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MXPA98002870A - Methods and apparatus for deriving arterial obstructions and / or carrying out other transvascular procedures - Google Patents

Methods and apparatus for deriving arterial obstructions and / or carrying out other transvascular procedures

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Publication number
MXPA98002870A
MXPA98002870A MXPA/A/1998/002870A MX9802870A MXPA98002870A MX PA98002870 A MXPA98002870 A MX PA98002870A MX 9802870 A MX9802870 A MX 9802870A MX PA98002870 A MXPA98002870 A MX PA98002870A
Authority
MX
Mexico
Prior art keywords
catheter
tissue
extravascular
location
passageway
Prior art date
Application number
MXPA/A/1998/002870A
Other languages
Spanish (es)
Inventor
Makower Joshua
C Evard Philip
R Machold Timothy
C Flaherty J
T Garibotto John
E Macaulay Patrick
B Whitt Jason
A Vidal Clade
J Redmond Russel
Original Assignee
Transvascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Transvascular Inc filed Critical Transvascular Inc
Publication of MXPA98002870A publication Critical patent/MXPA98002870A/en

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Abstract

The present invention relates to methods, devices and systems for revascularization, and / or to perform other medical procedures in intracorporeal vascular or non-vascular locations, within the body of a mammal. The methods generally comprise the formation of at least one extravascular passageway with respect to a target location or vascular or non-vascular target. In the methods of revascularization the extravascular passageway is used as a conduit to access or carry out procedures in the target location or vascular or non-vascular objective. Also disclosed are devices usable for forming the extravascular passages of the invention, as well as apparatuses for modifying, maintaining and / or closing such extravascular passages.

Description

METHODS AND APPARATUS FOR DERIVING ARTERIAL OBSTRUCTIONS AND / OR CARRYING OUT OTHER TRANSVASCULAR PROCEDURES Field of the Invention The present invention generally pertains to methods, devices, and medical systems, and more particularly to methods, devices, and systems for a) revascularization and / or b) for performing medical procedures at vascular or non-vascular sites within the body of a mammal.
Background of the Invention A. Background that is related to the Revascularization Procedures In modern medical practice, it is often desirable to derive segments of arteries that have become clogged, diseased or damaged. Typical surgical procedures used to bypass blocked, diseased or damaged segments of the blood vessels require open surgical exposure of the artery, and fixation (for example, suturing) of a tubular graft (for Ref.027248 example , homograft, xenograft, allograft, prosthetic or bioprosthetic graft) to the affected artery such that one end of the graft is connected upstream of the obstructed segment, diseased or damaged, and the other end of the graft is connected to the artery upstream of the graft. same. In this way, the arterial blood is channeled through the bypass graft, whereby the blood flow that is remote from the clogged, diseased or damaged segment of the artery is restored, and ischemia of the tissue, the infarction, is prevented, and other sequelae which result from altered blood flow through the affected artery. Although the graft of the surgical bypass of the arteries has been effected in various places within the body, it is more likely for such arterial bypass procedures to be effected by the treatment of either: coronary artery disease. or ii the peripheral vascular disease that affects the ext remides, n ^ ir.itT.ores.
Coronary Artery Disease The infiltration of the coronary artery continues to be one of the main causes of morbidity and mortality, in all cases. The etiology typical of coronary arr disease is characterized by the accumulation of atherosclerotic plaque within the coronary arteries. Such atherosclerotic plaque deposits tend to totally or partially block blood flow through the affected coronary arteries, and if left untreated they can lead to myocardial ischemia, infarction and death. For many years, the traditional surgical treatment of coronary artery disease has been coronary artery bypass surgery where the patient is usually anesthetized, placed on a cardiopulmonary bypass and the patient's heart is temporarily stopped. A thoracotomy (for example, a median or average sternotomy) is performed and the obstructed coronary blood vessels are exposed for surgical dissection. One or more segments of the patient's vein or of the internal mammary artery is / sor. cciectados for use as a graft (s) of the jer: empty .. The segments (s) collected from the vein c artery is / are then subjected to anastamosis with respect to the coronary artery (s) ( s) obs r__idc_, s; to form bypass conduit (s) around the arterial obstruction (s). Such a bypass of the traditional coronary artery is expensive, extremely invasive, and is associated with significant operative and postoperative complications.
An alternative for traditional coronary artery bypass surgery is balloon angioplasty. In balloon angioplasty, a flexible guide catheter is inserted percutaneously into a peripheral artery. { for example, the femoral artery) and transluminally advanced through the vasculature until the tip away from the catheter is within the ostium of an obstructed coronary artery. After that, a balloon catheter is passed through the guide catheter and into the obstructive lesion. The balloon catheter balloon is inflated one or more times to dilate the coronary artery in the region of the obstructive lesion. These balloon angioplasty procedures tend to be less expensive and less traumatic than traditional coronary artery bypass surgery. However, balloon angioplasty procedures of this type may be associated with a significant incidence of restenosis at the site of angioplasty. The cause and mechanism of such restenosis continues to be the subject of a study in progress. However, such restenosis has been generally attributed to either a) an increase in the mass of the artery wall (e.g., neointima formation), b) a thickening of the artery wall without substantial change in its mass (eg, vascular remodeling and / or c) the radial contraction of the artery wall dilated by the balloon during the healing of cracks and fissures that have been created by the process of balloon dilation. Another alternative to traditional coronary artery bypass surgery is intraluminal removal (for example, atherectomy) or ablation (for example, ultrasound, laser beam) of the obstructive material within the coronary artery. This intraluminal removal or ablation procedures are performed by passing a catheter mounted to the removal or ablation apparatus mounted to the catheter, through the vasculature to the site of coronary obstruction. The catheter mounted ablation removal apparatus is then used to cut, slice, apply sound, spray, or vaporize or otherwise ablate the obstructive material of the coronary artery lumen. These procedures should be performed with caution to avoid perforation or damage to the arterial wall, because such perforation or damage can lead to excessive bleeding or scarring and subsequent reocclusion of the lumen of the artery. Furthermore, these ablation procedures, in some cases at least, can be confused by the need to meticulously contain and remove the evicted or cut pieces of the obstructive material, to prevent such fragments of the obstructive material escaping into the patient's circulatory system. Examples of atherectomy catheters and other ablation apparatuses mounted to the catheter are described in U.S. Pat. Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman, et al), 4,808,153 (Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris), 4,924,863 (Sterzer), 4B70, 953 (Don Michael, et al.), 5,069,664 (Suess). , et al.), 4,920,954 (Alliger, et al.) and 5,100,423 (Fearnot), as well as foreign patent / patent publications EP0347098A2 (Shiber), W087-05739 (Cooper), WO89-06515 (Bernstein, et al. ), WO90-0130 (Sonic Needle Corp.), EP316789 (Don Michael, et al.), DE 3,821,836 (Schubert), DE2438648 (Pohlman), and EP 0443256A1 (Baruch). Other alternatives to traditional coronary artery bypass surgery have included minimally invasive endoscopic procedures which, ostensibly at least, can be performed through small incisions (eg, 1-3 cm) formed in the chest wall of the patient, by the insertion of a thoracoscope and the associated operative instrument through such incisions. One such minimally invasive coronary bypass procedure is described er. U.S. Patent No. 5,452,733 (Sterman et al). If perfected, these minimally invasive coronary artery bypass procedures may suffer from such minimally invasive procedures versus those who undergo traditional coronary artery bypass surgery. However, endoscopic surgical procedures of this type typically require a large amount of experience and operator training. further, as with traditional coronary artery bypass surgery, these thoracoscopic procedures are typically performed under general anesthesia, and typically require that one or more chest tubes be left in place during the postoperative period to drain any amount of blood from the chest. which leaks from the anastamosis of the graft and to reduce the pneumothorax which has been created by the formation of incision (s) of full thickness in the chest wall. In addition, some of these thoracoscopic coronary artery bypass procedures require that the patient be placed on the cardiopulmonary bypass, and that the patient's heart be temporarily stopped. Other of these thoracoscopic procedures imply that they will be usable without placing the patient in cardiopulmonary bypass, and without stopping the heart. However, these thoracoscopic procedures which are implied to be usable without cardiopulmonary bypass and heart detection, are relatively complex to perform and typically require the temporary fixation or ligation of the coronary artery which is to be derived. Consequently, even those thoracoscopic procedures which can be used without the cardiovascular bypass / arrest of the heart, are prone to unique and significant risks and difficulties due to the complexities of the procedure and the need to temporarily secure or completely close the artery (s). (s) coronary (s) that are derived. Accordingly, many of the disadvantages associated with traditional coronary artery bypass surgery, as well as some other potential disadvantages, may be associated with these minimally invasive tactical procedures. Another procedure previously described which does not actually result in blockages of the coronary artery but which nevertheless may be usable to improve sar-quinec flow to the ischemic regions of the myocardium, is ur. cr; cedi iento known as revascularization t rar.sriccárdica (TMR). In the procedure of TMP ur ... a penetrable pathway in the tissue, such as a y-rsyc laser probe, is used to form numerous portions of the full thickness through the ischemic m-eccardial parenchyma, and towards the camera. Left Side Left. The oxygenated blood from the left ventricle then flows out through such tracts of penetration, so that the ischemic myocardium is perfused. Examples of such transmyocardial revascularization procedures are described in U.S. Patent Nos. 5,554,152 (Aita et al.), 5,380,316 (Aita et al.), And 5,125,926 (Linhares et al.). A modification of the TMR procedure requires the formation of a transmyocardial passageway internally constricted and / or provided with valves (eg, an interstitial tunnel formed in the muscular wall of the heart) from the left ventricle of the heart to an obstructed coronary artery, downstream of the obstacle. Such modified TMR procedures are described in U.S. Pat. Nos. 5,287,861 (WilkR 5.40 * ^, 019 (Wiík), and 5,429,114 (Wilk). ii. Peripheral vascular disease Peripheral vascular disease commonly results from the accumulation of atherosclerotic plaque and / or other material in the peripheral arteries. In many cases, when the arteries of the lower extremities have become obstructed by peripheral vascular disease, a phenomenon known as intermittent claudication results. Intermittent claudication is characterized by progressive pain and weakness in the legs during exercise (ie walking or running). The typical surgical approach for the treatment of peripheral vascular disease, especially in patients exhibiting symptoms of intermittent claudication, is surgically exposed to the affected artery and subjected to anastomosis by a tubular bypass graft (e.g., a tube formed of woven polyester or expanded polytetrafluoroethylene (ePTFE)) to the affected artery such that one end of the graft is fixed upstream of the obstruction, and the other end of the graft is fixed downstream of the obstruction. In this way, arterial blood will flow through the graft of the tubular shunt and around the arterial obstruction, whereby blood flow to the portion of the artery downstream of the obstruction is restored. An alternative to traditional arterial bypass graft surgery for the treatment of peripheral vascular disease of the lower extremities is a procedure known as venous shunt in situ. These in situ vein shunting procedures are typically carried out by forming at least two (2) open incisions in the leg, to expose the affected artery to the sites upstream and downstream of the obstruction. A peripheral vein, which extends through the leg generally parallel to the affected artery, is then prepared by inserting an instrument into the vein to lyse or rupture the venous valves located within the vein. After this, any small branches or lateral tubes extending from the vein are cut, bound or blocked by embolization. The prepared vein is then transected in the places above and below the arterial obstruction, and the transected ends of the vein are placed in contact with, and sutured directly to, the artery at the sites upstream and downstream of the obstruction. In this way, the arterial blood flow becomes channeled through the prepared segment of the vein, such that the prepared segment of the vein will act as a bypass conduit around the arterial obstruction. Examples of in situ venous shunt procedures are described in White, R.A. and Fogarty, T.J., Peripheral Endovascular Interventions, p. 166-169, Mosby & Co. (1996). iii. Trauma and Other Diseases Which Can Damage the Flow Through the Arteries Several arteries of the body can be damaged by trauma (for example, lacerations, crush injuries, direct abdominal trauma) or can be invaded or compressed by extra-vascular disease processes (for example, proliferation and growth). of an adjacent tumor). The typical surgical approach to the treatment of arteries affected by such trauma or disease is to surgically and directly expose the affected segment of the artery, and after this a) resect and reconnect or b) derive the affected segment from the artery, restore arterial blood flow through or around the affected segment of the artery. In many such cases, the segment of the artery affected by the damage or disease may be so large as to prevent or prevent simple resection, removal of the affected segment, and end-to-end ossication of the adjacent severed ends of the artery. artery. In consecuense, in such cases where resection and end-to-end anastamosis are not an available option, it may be desirable to fix a tubular bypass graft (eg, a tubular graft formed from woven polyester, or ePTFE) to the affected artery , to derive the affected segment of the artery. Although a number of the surgical procedures described above represent relatively recent advances whereby the invasiveness and risk associated with traditional surgical approaches has been mitigated, a need remains in the art for the development of new, safe, and reliable procedures that are transluminal and minimally invasive to derive segments of arteries which have become obstructed, damaged or affected by a disease.
B. Background that Relates to Other Interventional / Surgical Procedures Extravascular Many types of surgical and interventional procedures have previously been formed in the organs, tissues or bodily cavities of the body. Traditionally, access to such organs, tissues or body cavities is achieved through the formation of one or more surgical incisions in the body, whereby the affected organs, tissues or body cavities are surgically exposed.
In recent years, substantial efforts have been made to develop "minimally invasive" surgical techniques whereby one or more endoscopes are used to observe the affected organ, tissue or body cavity, and where operating instruments or other devices are used. inserted in the body to perform the desired surgical or interventional procedure through incisions of "minimum access" (eg, less than 3 cm) relatively small. Although the advent of these endoscopic "minimal access" surgical procedures may have advantages over traditional open surgical techniques in that they can minimize the size of the incision. Surgical, and as a result, may lead to less postoperative discomfort, such er.d procedures are frequently limited to prc red_r? e :. : s within the cavities or lumens of the body, according to which they can be filled with a liquid. Are they insufflated with a gas to provide a correct area within which the er.j- are placed? - ^ p: o s, operative (s) and the instrument (s). In view of the limitations associated with the even more modern surgical and interventional procedures of "minimal access", there remains a need in the art for the development of new methods and apparatus for accessing tumors, organs, tissues and other extravascular sites within the body, to allow the operation of interventional and / or surgical procedures without the need to form any open surgical incision in the body.
Brief Description of the Invention In general, the present invention provides methods for using the vascular system of the body of a mammal as a conduit for performing various types of medical procedures. Due to the wide distribution of vessels ducts throughout the body, the vascular system provides a path through which devices can be guided to obtain access in close proximity to selected treatment sites which otherwise they can be accessible only through the direct incision. Specific methods of the present invention include a) revascularization methods, and b) methods for performing various types of medical procedures in other intracorporeal locations within the body. The methods of revascularization of the present invention generally comprise the formation of one or more extravascular passages between the blood vessels, the different locations on the same blood vessel, or a blood vessel and another anatomical structure containing blood (for example, the chamber of the blood vessel). heart), in such a way that blood will flow through such passage (s). In many applications of the invention, it will be desirable for oxygenated blood (i.e. blood which has a p02 value greater than 50) to be carried through the extravascular passage (s) for the purpose of providing or improving perfusion of tissues. The extravascular passages according to the revascularization methods of the present invention can be formed by a transluminal, percutaneous approach or approach, which prevents the formation of open surgical incisions in the body of a mammal. These revascularization methods of the present invention can be used in the peripheral blood vessels and / or in the coronary blood vessels. FromIn accordance with the methods of revascularization of the present invention, methods are provided to provide the flow of arterial blood to tissue which has been stripped of blood due to the presence of an obstruction, damage or disease within a segment of a artery. The method generally comprises the step of forming a first extravascular passageway between an anatomical conduit which contains the arterial blood (for example, an artery or chamber of the left side of the heart), and a blood vessel which will perfuse the stripped or free tissue. of blood, in such a way that the arterial blood will pass through the flow passage of the extravascular blood and into the blood vessel, to thereby perfuse the free tissue of the blood through the blood vessel. In some applications of this method, the first passageway of blood flow will be formed between an adjacent artery and vein, such that blood will flow from the artery to the adjacent vein and subsequently pass through the vein in the direction retrograde so that the tissue will retroperfuse through the venous vasculature. Alternatively, a second passageway for blood flow can be formed between the vein and the artery where obstruction, damage or disease is localized, such that the arterial blood which is introduced into the vein will be reintroduced to the artery, downstream of the segment affected by the obstruction, the damage or the disease, of the same, for which the free tissue of the blood is perfused through the endogenous artery where the segment affected by the obstruction, the damage or the disease is localized.
The methods of the present invention for effecting the medical procedure (s) at the target site (s) or vascular target (s) or non-vascular (s) within the body, broadly comprise the step of forming at least one extravascular passageway from a blood vessel to another intracorporeal location (eg, blood vessel, organ, body cavity, tumor, etc.) and subsequently passing a substance or apparatus through the passageway extravascular to perform the desired medical procedure at the selected intracorporal site. In addition, according to the invention, a device is provided which is insertable into a blood vessel and usable to form an extravascular passageway which extends from the blood vessel within which the catheter device is inserted to a target site and objective. The target site may be a) another blood vessel, b) another anatomical structure containing blood (eg, the heart chamber, c) another location on the same blood vessel, or od) an extravascular location (eg, the organ, tumor, body cavity, etc.). The extravascular catwalks formed by this catheter device can be used to effect revascularization and / or methods of the medical procedures of the present invention, as summarized herein above. This catheter device forming a passage can comprise an elongate, flexible catheter body having a tissue penetrating element (eg, an element, device or energy flow) which is capable of passing from the catheter body, to form a passageway through the wall of the blood vessel in which the catheter is placed, and through any other tissue placed between the blood vessel and the target or target location (eg, another blood vessel, anatomical structure, location) extravascular, or another location on the same blood vessel) to which the passageway is desired to extend. The penetrating element of the tissue may comprise a suitable type of tissue penetrating element, device or energy flow, which includes but is not necessarily limited to a solid and / or hollow needle, a needle with a trocar tip (with or without a liner). foldable surrounding), a laser beam, an element emitting a laser beam, an electrocautery probe, a hot tip probe, a tissue penetrating, rotating device, or an ultrasonic ablation probe. Optionally, the catheter device may be equipped with a suction lumen, inflatable balloon (s) or other attributes or structural apparatuses usable to facilitate or assist in the passage of the tissue penetrating element (eg, the element, apparatus, etc.). , energy flow) from the blood vessel to the target location or target selected. Also, optionally, the tissue penetrating element of the catheter device may incorporate a guide wire lumen or other means for passing a guidewire through the extravascular passageway formed by the tissue penetrating element. In addition, according to the invention, the catheter device forming the passageway of the preceding character can be combined with one or more devices to orient the penetrating element of the tissue to ensure that the extravascular passageway is formed in its intended location. Such an orientation apparatus can be mounted on c incorporated in the catheter that forms the passageway. C, tc.1 orientation apparatus can be formed separately from the catheter that creates the catwalk and uses .JO in conjunction with the catheter, from any suitable intracorporal and / or extracorporeal uMcation. The orientation apparatus may comprise several rippers and active and / or passive devices, but not limited thereto, an extracorporeal ultrasound device, a Doppler extracorporeal device, a device radiographic intracorporai c ext raer, rcoral, a magnetic resonance imaging apparatus, a tomography apparatus, induction bins, electromagnetic devices, and various markers that carry the catheter, which are identifiable by radiographic, sonic, ultrasonic, photographic, MRI , or other means. Still further in accordance with the invention, passageway modifying devices are provided for unloading, coating, branching, longitudinally compressing and / or otherwise modifying the extravascular passage (s) which are formed by the present invention. . The additional advantages and advantages of the present invention will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiments described hereinafter, wherein certain embodiments and currently preferred examples of the invention are described in detail. .
Brief Description of the Drawings Figure 1 is a front perspective view of a heart uman '. which shows the typical locations of the coronary arteries and the veins on it.
Figure lb is a rear perspective view of the human heart showing the typical positions of the arteries and veins thereon. Figure 1c is a view in longitudinal section through an adjacent coronary artery and a coronary vein within segment 1c of Figure 1, wherein the passages for blood flow have been formed in accordance with the present invention to derive a localized obstruction within the coronary artery. Figure ld is a cross-sectional view through lines ld-ld of figure lc. The figure is a diagram of the Brouck-Moscheau triangle, an anatomical signal which is defined by certain coronary arteries and coronary veins of the human heart, as viewed on an x-ray radiograph from the right anterior oblique observation plane. Figure 1 is a perspective view of an alternative revascularization method of the present invention wherein an extravascular interstitial passageway is formed from a first location on a blood vessel (upstream of an obstruction) to a second location thereon. blood vessel (downstream of the obstruction).
Figure 1f 'is a perspective view of the blood vessel shown in Figure 1, following the complete application of the revascularization method of the present invention to form a bypass passage around the obstruction. Figure 2 is a perspective view of a human body incorporating a schematic illustration of a transvascular method for performing a medical procedure in an extravascular location within the body, in accordance with the present invention. Fig. 2a is an enlarged perspective view of the target tissue of Fig. 2, showing the manner in which a penetrating element of the tissue is passed through the catheter that forms the passageway toward the target tissue or target . Figure 2a 'is an enlarged view of the target tissue of Figure 2 showing an access conduit which has been advanced through, and / or exchanged into, the extravascular passageway and toward the target tissue. objective. Figure 2b is a schematic view showing a resident sampling / delivery cannula having a subcutaneous injection port for repetitive infusion / extraction of the material to / from a target or target area or to verify the conditions in the target area or target.
Figure 2c is a schematic view showing a catheter inserted through the extravascular passageway for the temporary deployment of a device towards, checking the conditions on, or infusing / extracting the material to / from the target or target area. Figure 2d is a schematic view showing a permanently placed device (e.g., deviation of fluid drainage) utilizing the extravascular passageway of the present invention. Figure 2e is a schematic view showing a catheter inserted through the extravascular passageway of the present invention and into the lumen of another tubular anatomical passage, for sampling, access, verification, or operation of an interventional surgical procedure. inside the anatomical tubular passage. Figure 2f is a schematic view showing a transvascular procedure for performing extravascular microsurgery, in accordance with the present invention. Figure 3 < _t is a longitudinal sectional view showing a blood flow passageway, not modified, formed in accordance with the present invention.
Figure 3b is a longitudinal sectional view showing an internally coated blood flow passageway, formed in accordance with the present invention. Figure 3c is a longitudinal sectional view showing a flow passageway of longitudinally compressed blood formed in accordance with the present invention. Figure 3d is a longitudinal sectional view showing a flow passageway of the present invention having a small non-protruding tube or a small tubular graft placed therein. Figure 3d 'is a perspective view showing an optional projection and / or optional projections which can be incorporated into a small non-protruding tube or small tubular graft disposable within a passageway for the blood flow of the present invention. according to figure 2d. Figure 3e is a sectional view through a flow passageway of the blood of the present invention, having a first embodiment of a small semi-protruding or protruding small tube or small tubular graft placed therein.
Figure 3f is a sectional view through the first and second blood flow passages of the present invention, having a second embodiment of a small protruding tube or small tubular graft placed therein. Figure Aa is a schematic illustration of a first approach for forming the arteriovenous blood flow passages according to the present invention. Figure 4b is a schematic illustration of a second approach for forming the arteriovense blood flow passageways according to the present invention. Figure 4c is a schematic illustration of a third approach for forming arteriovenous blood flow passages. according to the present invention. The figure _i is _r, -. schematic illustration of a fourth approach for the passageways of blood flow arter: cver..s- according to the present invention. Figure 4 < rs a schematic illustration of a fifth approach to form a passageway of arterial blood flow. according to the present invention.
Figure 5a is a longitudinal sectional view of two (2) adjacent blood vessels, illustrating a first means for orienting, directing and guiding a tissue penetrating element to form a flow passageway for the arteriovenous blood according to the present invention . Figure 5b is a longitudinal sectional view of an adjacent artery and vein, illustrating a second means for orienting, directing and guiding a tissue penetrating element to form a flow passage of the arteriovenous blood according to the present invention. Figure 5c is a longitudinal sectional view of an adjacent artery and vein, illustrating a third means for orienting, directing and guiding a tissue penetrating element to form a flow passage for the arteriovenous blood according to the present invention. Figure S-. is a longitudinal sectional view of an adjacent artery and vein, illustrating a median room for orienting, directing and guiding a penetrating element of the tissue to form a flow passageway for the arteriovenous blood according to the present invention. Figure 5e is a schematic view showing a method for using radiographically visible, passive markers to orient, direct or guide a tissue penetrating element to form an extravascular passageway according to the present invention. Figure 5e 'shows a first type of radiographic markers which can be used according to Figure 5e. Figure 5e '' shows a second type of radiographic markers which can be used according to Figure 5e. Figure 5e '' 'shows a third type of radiographic markers which can be used according to Figure 5e. Figure 5f is a schematic view showing a method for using an ultrasonically visible marker to direct, align and / or guide a tissue penetrating element to form an extravascular passageway according to the present invention. Figure 5f is a perspective view of the ultrasonically visible marker shown in Figure 5f. Figure 5g is a schematic view of a method for using magnetic resonance imaging (MRI) to orient, direct or guide a tissue penetrating element to form an extravascular passageway according to the present invention.
Figure 5g 'is a perspective view of a first modality of a marker visible by magnetic resonance imaging (MRI) to facilitate orientation, direction and / or guidance of a penetrating element of the tissue to form an extravascular catheter of according to the present invention. Figure 5g '' is a perspective view of a second modality of a visible marker for magnetic resonance imaging (MRI) to facilitate orientation, direction and / or guidance of a tissue penetrating element to form an extravascular passageway according to the present invention. Figure 5h is a schematic view showing how to use a Doppler device to facilitate orientation, the direction and / or guidance of a penetrating element of the tissue to form an extravascular passageway according to the present invention. Figure 5i is a schematic view showing the manner of using a pressure sensitive apparatus to facilitate orientation, direction and / or guidance of a tissue penetrating element to form an extravascular passageway according to the present invention. Figure 5j is a schematic view showing the manner of using a transmitter and receiver apparatus for orienting, directing and / or guiding a tissue penetrating element to form an anterior-venous blood flow passageway according to the present invention. Fig. 5k is a schematic view showing a means for using an induction and transmission coil apparatus for orienting, directing and / or guiding a tissue penetrating element to form a flow passage of the arteriovenous blood according to the present invention. Figure 51 is a schematic view showing the manner of using a magnetic apparatus to orient, direct and / or guide a tissue penetrating element to form a passageway for the flow of arteriovenous blood according to the present invention. Figure 6a is a longitudinal sectional view of a portion of a penetrating catheter of the transvascu- lar tissue of the present invention, showing a first means for exiting the tissue penetrating element from the catheter. Figure 6b is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing a second half to exit the tissue penetrating element from the catheter. Figure 6c is a longitudinal sectional view of a portion of a penetrating catheter of the cardiovascular tissue of the present invention, showing a third means for exiting the penetrating element of the tissue from the catheter. Figure 6d is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing a fourth means for exiting the tissue penetrating element from the catheter. Figure 6d 'is a perspective view through the far end of the catheter device shown in Figure 6d. Figure 6e is a longitudinal sectional view of a portion of a transvascular tissue penetrating catheter of the present invention, showing a fifth means for exiting the tissue penetrating element from the catheter. Figure 6f is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing a sixth means for exiting the tissue penetrating element from the catheter. Figure 6g is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing a seventh means for exiting the tissue penetrating element from the catheter.
Figure 6h is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing an eighth means for exiting the tissue penetrating element from the catheter. Figure 6i is a longitudinal sectional view of a portion of a penetrating catheter of the transvascular tissue of the present invention, showing a ninth means for exiting the penetrating element of the tissue from the catheter. Figure 7a is a longitudinal sectional view of a portion remote from the first embodiment of a penetrating element of the fabric according to the present invention. Figure '' a 'is a cross-sectional view through line 7a' -7a 'of figure 7a. Figure "r is a longitudinal sectional view of a p.rc -n away from the second embodiment of an element of the fabric according to the present invention. Figure ^ c is a sectional view. longitudinal section of the tissue in accordance with the present invention The figure "is a longitudinal sectional view of a portion remote from the fourth embodiment of a penetrating element of the tissue according to the present invention. Figure 7d 'is a cross-sectional view through the line 7d' -7d 'of Figure 7d. Figure 7e is a longitudinal sectional view of a portion remote from the fifth embodiment of a tissue penetrating element according to the present invention. Figure 7e 'is a cross-sectional view through line l' -le 'of Figure 7e. Figure 7e '' is a cross-sectional view through an alternative embodiment of the device shown er. Figure 7e, comprising a hollow tube having a stylet or solid probe placed therein. Figure 1 is a longitudinal sectional view of a portion remote from the sixth embodiment of a penetrant-element. of the fabric according to the present invention. The figur_. * "f is a perspective view of the trocar elongate element, which forms a portion of the penetrating element of the fabric shown in Figure 7f, Figure 7g is a longitudinal sectional view of a portion remote from the seventh embodiment of a penetrating element of the fabric according to the present invention, Figure 7h is a longitudinal sectional view of a portion remote from the eighth embodiment of a penetrating element of the fabric according to the present invention. longitudinal section of a portion remote from the ninth embodiment of a penetrating element of the fabric according to the present invention Figure 7j is a longitudinal sectional view of a portion remote from the tenth embodiment of a penetrating element of the fabric according to the invention. present invention Figure 7k is a longitudinal sectional view of a portion remote from the eleventh embodiment of a tissue penetrating element according to the present invention. Figure 71 is a longitudinal sectional view of a portion remote from the twelfth embodiment of a tissue penetrating element according to the present invention. Figure 7m is a longitudinal sectional view of a portion remote from the thirteenth embodiment of a tissue penetrating element according to the present invention.
Figure 8a is a longitudinal sectional view of a first embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8b is a longitudinal sectional view of a second embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8c is a longitudinal sectional view of a third embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8d is a longitudinal sectional view of a fourth embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8e is a longitudinal sectional view of a fifth embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8f is a longitudinal sectional view of a sixth embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8g is a longitudinal sectional view of a seventh embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8h is a side elevational view taken by cutting, partial, of an eighth embodiment of an apparatus for modifying an interstitial passage formed in accordance with the present invention. Figure 8h 'is a side elevational view taken away, partially, of a variation emitting energy of the mode shown in Figure 8h. Figure 8h "is an elevation view of the device of Figure 8h that is used to modify the flow passage of the arteriovenous blood according to the present invention. Figure 9a is an elevation view of a first embodiment of a device usable for longitudinally compressing an arteriovenous catwalk formed in accordance with the present invention. Figure 9a 'is an exploded perspective view of the device shown in Figure 9a. Figure 9b is an elevation view of a second embodiment of a device usable for longitudinally compressing a flow passage of the arteriovenous blood according to the present invention.
Figure 9b 'is a partial longitudinal sectional view of the device of Figure 9b mounted within a delivery catheter. Figure 9b "is a perspective view of the device of Figure 9b partially ejected from its delivery catheter. Figure 9b '' 'is a perspective view of the device of Figure 9b fully ejected from its delivery catheter. Figure 9c is an elevation view of a third embodiment of a device usable for longitudinally compressing a flow passage of the arteriovenous blood according to the present invention. Figure 9d is an elevation view of a fourth embodiment of a device usable for longitudinally compressing a flow passage of the arteriovenous blood according to the present invention. Figure 9e is an elevation view of a fifth embodiment of a device usable for longitudinally compressing a flow passage of the arteriovenous blood according to the present invention. Fig. 9f is an elevation view of a sixth embodiment of a device usable for longitudinally compressing a flow passage of the arteriovenous blood according to the present invention. Figure 9f is a partial longitudinal sectional view of the device of Figure 9f mounted within a delivery catheter. Figure 9f '' is a perspective view of the device of Figure 9f when it is mounted within its delivery catheter. Figure 9 '' 'is a longitudinal sectional view of the device of Figure 9f partially deployed outside its delivery catheter. Figure 9i '' '' is a cross-sectional view of the device of Figure 9f deployed completely outside its delivery catheter. Figure 10a is a perspective view of a first embodiment of a penetrating catheter device dei te ij. : rar.svascular of the present invention. Figure ICr is a longitudinal sectional view through line 10b-10b of Figure 10. Figure .c is a longitudinal sectional view through line 10c of Figure 10a.
Figure 10 is a cross-sectional view through line 10O-lOd of Figure 10a. Figure 10c 'is a schematic view of an apparatus that pushes the optional guide liner / wire, which can be incorporated in any embodiment of the penetrating catheter of the transvascular tissue of the present invention. Figure 10c '' is a schematic view showing the apparatus of Figure 10c 'as the tissue penetrating element of the catheter device which is penetrating through the tissue. Figure 10c '' 'is a schematic view showing the device of Figure 10c after the penetrating element of the tissue has penetrated through the tissue and into a vascular lumen or an open cavity. The figure lid is a view in longitudinal section through a component of the manual part of a second modality of a penetrating catheter device of the vascular tissue of the present invention. The lit figure is a partial longitudinal sectional view of a remote portion of the second embodiment of the penetrating catheter device of the transvascular tissue of the present invention.
Figure 11c is a longitudinal section showing the device of Figure 11b during a first stage of a tissue penetration procedure. Figure 11c is a longitudinal section showing the device of Figure 11b during a second stage of a tissue penetration procedure. The figure lid is an elongated longitudinal section view of a lid segment of figure 11c.
Detailed Description of the Preferred Modalities The following detailed description and the drawings to which it relates, are provided for the purpose of describing certain currently preferred embodiments of the present invention only, and are not intended to limit the scope of the invention in any way. Really, it will be appreciated that the detailed descriptions and examples described herein below are provided only as examples or illustrations of certain ways in which the invention may be used or practiced. These examples and illustrations are not intended to provide an exhaustive description of all possible embodiments and examples of the invention, but rather, are illustrative of some but not all of the applications to which the invention may be. applied The Methods of the Present Invention i. Revascularization Methods Broadly explained, the revascularization method of the present invention provides a method for the establishment of one or more path (s) through which blood can flow from or into at least one blood vessel. In most cases, the blood which flows through the passage will preferably have a p02 in excess of about 50. In some cases the extravascula route (s) will be used to derive a blocked segment, damaged or affected by a disease, of an artery. In some embodiments of the invention, only a primary blood flow path (eg, a pathway or passageway from the artery upstream of the obstruction) will be formed between an artery obstructed, damaged, or affected by a disease (or other undamaged artery). or an anatomical structure filled with blood such as a chamber of the heart), and a vein by which the arterial blood will then be allowed to flow in the backward direction through the vein, so that the tissues are retroprofused through the venous vasculature. In other embodiments of the invention, one or more passages of secondary blood flow will also be formed between the obstructed artery and the vein, downstream of the obstruction, such that the arterial blood which has been introduced into the lumen of the vein to through the passage (s) of primary blood flow may subsequently be introduced or reintroduced into the lumen of the artery, downstream of the obstruction, thereby perfusing the tissues through the remaining portion (e.g., unobstructed) of the obstructed artery). Although the anatomical illustrations provided in Figures la and Ib are specific with respect to the coronary vasculature, it will be appreciated that the methods of the present invention can be applied to blood vessels throughout the body and are not necessarily limited to the treatment of obstructed coronary arteries (for example, the femoral-popliteal region, the aorta-iliac region, etc. With reference to the drawings, figures 1 and 1 provide detailed displays of the normal vascular anatomy of a human heart where the The coronary arteries are substantially parallel and adjacent to the coronary veins The specific anatomical structures shown in the figures, lb, are labeled according to the following legend: A Aorta - AIV Intraventricular Vein Anterior CA Coronary Artery CV Vena Coronary CS Coronary Sine CIR Circumflex Artery IVC Vena Cava Inferior LAD. . . Anterior Descending Artery Left SVC Vena Superior Cava PA Pulmonary Artery PV Vena Pulmonary TA Tunica Adventitia TM Tunica Media TI Intima Tunica GVC Coronaria Mayor Figures lc-ld illustrate a specific application of the present invention, wherein an OB obstruction is located within a coronary artery located on the left inner aspect of the heart. As shown, the obstructed CA coronary artery is located adjacent, and generally parallel to, a CV coronary vein. A first passageway 10a for blood flow is formed between the CA coronary artery and the adjacent CV coronary vein, in a location upstream of the OB arterial obstruction. Also, in the display of Figure 1, a second passageway 10b for blood flow has been formed between the lumen of the coronary vein CV and the lumen of the coronary artery CA, in a location downstream of the OB obstruction. Also, in these figures, the optional embolization elements 12a, I2b are shown to have been placed in the lumen of the coronary vein CV at sites near the first passageway 10a for blood flow, and away from the second passage 10b for the flow of blood, optional. This optional embolization element serves to guide the flow of arterial blood which is introduced to the CA coronary artery through the first passageway 10a for the flow of blood, t is of a segment of the adjacent CV coronary vein, and through the second passageway 10b for the flow of the heal so that the arterial blood is reintred. to the lumen of the coronary artery CA, current aba e ae 1 _ »obstruction OB. The embolization elements 12a, 12b may be any or a combination of devices sufficient to block or impede flow, such as coils or spools; ne static materials such as collagen, Gelfoa ™ or fiprma, small covered tubes or structures, detachable balloons, valve structures, clips, fasteners or plugs, etc. In addition, the function served by these elements can also be effected using various methods that include ligation or bonding, welding, coagulation, or other surgical methods. As illustrated in the cross section shown in Figure 1, each passageway 10 for blood flow of the present invention is essentially an interstitial tunnel which extends through the wall of an artery (such as a coronary artery CA). ) through the wall of an adjacent vein (such as a coronary vein CV) and through any connective or membranous tissue which may be located between the CA coronary artery and the CV coronary vein. In this way, each passage 10 of blood flow acts as a flow conduit between the lumens of the CA coronary artery and the CV vein. The figure is a diagram of a portion of the coronary vasculature known as the Brouck-Moscheau Triangle. The Brouck-Moscheau Triangle is defined by the anterior descending coronary artery LAD, CIR circumflex cephalic artery, anterior intraventricular vein AIV and major coronary artery GCV, as shown. Obstructions resulting from the accumulation of the atherosclerotic plaque are frequently found in the proximal portions of the left anterior descending artery LAD and / or the CIR circumflex artery. The revascularization methods of the present invention can be used to treat such obstructions of the left anterior descending artery LAD and / or circumflex artery CIR by forming the passageways 10 for proper blood flow, between the arteries and the veins surrounding the artery. Triangle of Brouck-Moscheau. For example, if an obstruction is present in the proximal portion of the left anterior descending artery LAD, a first passage 10a for blood flow can be formed between the major coronary artery GCV and the circumflex artery CIR and a second catwalk 10b for the artery. Blood flow can be formed between the left anterior descending artery LAD and the anterior intraventricular artery AIV, in a location downstream from the obstruction. A lumen-blocking element 12 can be placed within the major coronary artery GVC, close to the first catheter 10a for blood flow and / or within the anterior intraventricular vein AIV remote from the second catheter 10b for flow of the blood. blood in such a way that the arterial blood from the CIR circumflex artery will flow through the first passageway 10a for blood flow, through the major coronary artery GCV, through the anterior intraventricular vein AIV and toward the left anterior descending artery LAD, downstream of the obstruction. Alternatively, in cases where the obstruction is present in the circumflex artery CIR, the first passageway 10a for the blood flow and the second passageway 10b for the flow of blood can be inverted, such that the blood flowing Through the left anterior descending artery LAD will flow through the anterior intraventricular vein AIV, through the major coronary artery GCV and into the circumflex artery CIR, downstream of the obstruction. In accordance with these examples, it will be appreciated that the revascularization method of the present invention can be used in a manner which obtains arterial blood from an artery or from any other source (eg, the left ventricle), and such blood passes arterial to another artery. Furthermore, according to the revascularization methods of the present invention, it will be appreciated that the second passageway 10b for blood flow, in some cases, can be eliminated and arterial blood can be provided to the blood free regions of the blood. myocardium by retroprofusion through the anterior interventricular vein AIV or the major coronary vein GCV. It will be appreciated that in some applications of the revascularization method of the present invention, the extravascular catwalk 10 may comprise an interstitial tunnel which extends from a first place to a second place, on the same blood vessel. As shown in FIG. 1f, a blood vessel BV having an OB obstruction formed therein can be derived using a catheter 100 forming a passageway of the present invention, whereby a penetrating element 102 of the tissue is made pass through the wall of the blood vessel upstream of the obstruction, through the adjacent tissue, and subsequently through the blood vessel pareo downstream of the obstruction. In this way, an interstitial passageway 10, shown in FIG. 1f ', forms a bypass conduit around the obstruction OB in the blood vessel BV. ii. Methods for Carrying Out Procedures Surgical or Interventional in Extravascular Places In addition to the revascularization methods described above, the present invention also includes methods for performing various surgical or interventional procedures in extravascular sites within the body. These methods of the present invention are performed by forming one or more extravascular passages from a blood vessel to an extravascular site or site (eg, the organ, tissue, body cavity, etc.), and subsequently passing one or more devices that perform the procedure through the extravascular passage to carry out the surgical or interventional procedure desired in the extravascular site. The types of surgical or interventional procedures which may be performed according to this method of the present invention include: SUPPLY OF THERAPEUTIC MATTER • Provision of a drug substance that can flow; • Implantation of an implantable drug delivery device (for example, microspheres, etc.); • Supply of medical treatment fluids; • Implantation of the access catheter to initiate the dosage of the drug; • Implantation of genetic material, cells, viral or microbial vectors, etc.
TEMPORARY OR PERMANENT DEPLOYMENT OF A (S) DEVICE (S) • Implantation of a stimulator (electric or physical); • Sensor implant; • Electrode implant; • Implant of the transmitter, receiver or transponder; • Implant the support element (for example, the small tube); • Implant marker (for example, radiographically visible markers, or solutions.
RESECTION, EXCISION OR ABLATION OF THE TISSUE • Abiaci r. tissue destruction; • C transection of the tissue (for example, the r &r;, fibers); • Resection and removal of neoplasms, tissue and er. íerrr.e, etc .; • Dilation, staging or other modification of the endogenous to restore the flow, the flow, the configuration, and the function.
SAMPLING APPLICATIONS • Sampling of the tissue (for example, biopsy); • Sampling of solid material (for example, calculations, tophi, etc.); • Sampling of material that can flow (for example, biological fluid).
VERIFICATION APPLICATIONS • Determination of the pressure, pH, temperature, oxygen saturation, partial pressure of the dissolved gas, ECG, EEG, evoked potentiolos, or other variables which are measurable in the target area.
Figures 2-2f are provided for the purpose of further describing and illustrating some of the interventional and / or surgical procedures which may be effected in accordance with this embodiment of the present invention. Figure 2 shows a schematic illustration of the human body in which a catheter apparatus 100 that forms a passageway of the present invention has been inserted percutaneously into a blood vessel (e.g., the femoral vein) and has been advanced through from the vena cava, the internal jugular vein and the Galen's ampulla, to a desired location adjacent to the target area or extravascular target (for example, the ventricle of the brain). After this, a penetrating element 102 of the tissue is passed from the catheter 100 through the wall of the cerebral blood vessel where the remote portion of the catheter 100 is located and the penetrating element of the tissue is advanced through the tissue of the tissue. brain adjacent to a target T location or extravascular target, inside the brain. In this manner, an extravascular passage 10 has been formed from the cerebral blood vessel to the target location T or extravascular target. When necessary, the passageway 10 which is initially formed by the tissue penetrating element 102, may be unloaded, enlarged or modified in accordance with the apparatus and methods for modification of the passageway shown in Figures 8a-8h and described with more detail here later. Figure 2a is an enlarged view of the target area T or target and the adjacent blood vessel BV within which the catheter device 100 forming the catwalk, progress has been made. Initially, the tissue penetrating element 102 of the catheter device 100 that forms the passageway is advanced outside the catheter 100, through the wall of the blood vessel BV, and through the tissue which is located between the blood vessel BV and the area T of target or target. The tissue penetrating element 102, used in this application, preferably incorporates a lumen 114 through which a secondary guide wire GW2 can be advanced toward the target area T or target. After this, the tissue penetrating element 102 can be retracted and removed with the catheter 100 forming the passage, leaving the secondary guide wire GW2 in place. As shown in Figure 2a, an access cannula 103 can then be advanced over the pre-positioned secondary guidewire GW2 in such a way that the cannula 103 extends through the vasculature, through the extravascular passage 10 formed by the element 102 penetrating the tissue and toward the target area T or target. This access cannula can then be used as a conduit for the introduction of drugs, the implantation of devices, sampling, verification, deployment of surgical devices or other applications according to the methods for performing the surgical or interventional procedures in IACaisations. extravascular, described here above.
Figures 2b-2f illustrate the specific examples of the types of extravascular surgical or interventional procedures which may be effected in accordance with this aspect of the invention. With reference to Figure 2b, a subcutaneous door apparatus 105 may be mounted on the proximal end of the access cannula 103, and may be used for the injection or withdrawal of flowable substances (eg, drugs, treatment fluids). medical, radiographic contrast solutions, cells, genetic material, microbial or viral vectors, etc.) through the access cannula 103, and towards the target area T or target. Also, the door or opening apparatus 105 and cannula 103 can be used to effect periodic verification of pressure or other conditions in the target area T or target (e.g., filling cannula 103 with fluid and inserting a needle connected to a pressure transducer within the door or opening apparatus 105, a reading of the pressure in the target area T or target can be obtained). Accordingly, FIG. 2b illustrates the manner in which a resident access cannula 103 having an injection port 105 positioned subcutaneously can be used for continuous infusion or extraction of the flowable material to / from the target area T or target . Specific examples of the types of conditions which can be treated by repeated infusions of drugs to a specific target area T within the body, include Parkinson's disease, epilepsy, hypertension, tumors, depression, Alzheimer's disease, sleep disorders , behavioral disorders, motor dysfunctions, etc. Additionally, the access cannula 103 and the injection port or opening 105 can be used as a means to periodically infuse fluids or replacement solutions to perform various types of replacement therapies. These applications can also be carried out with the device shown in Figure 2c. Figure 2c shows an alternative arrangement where the access cannula 1C3 is exteriorized and is used as ur. conduit for the passage of a temporary device 106 dentre - -I area T of target or target. The device 106 may be connected to an extracorporeal apparatus IC "7 the c_-1 will provide some form of energy to the lube device, or receive the information from the ICt device Examples of the types of extracorporeal apparatus 1 -7 which may be used include, but are not necessarily limited to, electric signal generators, electrocautery devices, radio frequency signal generators, cryogenic devices, ultrasonic generators, oscilloscope forms, monitors, chart recorders, galvanometers, lightning laser, telescopes, other instrumentation, etc. Specific examples of the types of treatments which can be delivered to the target area T or targets, by means of a temporarily placed device 106, include tissue ablation by radiofrequency (e.g. the nervous tracts or the arithmogenic tracts inside the heart), the cryogenic destruction of the t ejido (for example, of a tumor), electrocautery (for example, to stop a hemorrhage or to ablate a tissue), etc. Examples of the types of verification or information retrieval operations which can be used in relation to temporarily placed device 106 include localized EEG measurements, localized ECG measurements. The registration of galvanometric responses, oxygen saturation measurements, partial pressure measurements of gases dissolved in fluids, pH measurements, electrode determinations of specific electrolyte concentrations or other chemical substances, etc. . Figure? D shows an application of the present invention wherein the access cannula 103 is used to continuously drain the fluid from the target area T or target. In this way, the proximal portion of the access cannula 103 is provided with a plurality of exit openings 109 such that excess fluid is collected within the target area T or target will be drained approximately through the lumen of the access cannula. 103 and outside the outlet openings 109. The proximal portion of the access cannula 103 having the outlet openings 109 formed therein can be exteriorized such that the excess fluid is drained to a localized container or container. extracorporeally, or alternatively be implanted in another location within the body (for example, the peritoneal cavity) in such a way that the excess fluid will pass into another such body area where it can be assimilated by the natural physiological functions without causing an injury or damage to the body. An example of such an application is the use of cannula 103 as a resident bypass or draining excess cerebrospinal fluid from a ventricle of the brain to a secondary location (eg, the peritoneum) within the body. Because the cannula 103 has been implanted through the vasculature and through the extravascular passageway 10 created according to the invention, the technique used for implanting the cannula 103 can be performed percutaneously without requiring large surgical incisions such as it may be typical of other methods used to implant deviating fluid drainage devices used for the treatment of hydrocephalus or hydrocephalus and other disorders. Figure 2e shows another specific application of the present invention, wherein the access cannula 103 extends from the blood vessel BV, through the extravascular passageway 10 of the present invention and towards the lumen 111 of a secondary tubular anatomical passage or conduit which is the blank T in this application or request. The types of tubular passages or ducts which can form the target or T target in this application of the invention include blood vessels, gene-urinary ducts, exocrine ducts, endocrine ducts and lymphatic ducts. After the access cannula 103 has been placed within the lumen 111 of the target or catheter T or catwalk, any of the applications listed above for this methodology can be used including the extraction of the drug infusion samples, the deployment of devices, etc. Figure 2f illustrates yet another specific example of an application of the invention wherein the access cannula 103 extends through the vasculature, through an extravascular passageway 10 of the present invention, and toward a target area T or target in such a way that one or more instruments 113 can be passed to the target area T or target for the purpose of performing a surgical procedure (eg, microsurgical) within the target area T or target. In this manner, an externalized control system 115 may be connected to the surgical instrument (s) 113 and may be used to effect the desired operation and manipulation of the surgical instrument 113 within the target area T or target. iii. Types of Passages Figures 3a-3f, and the detailed description described hereinafter, describe certain types of extravagant passageways 10 which may be formed in accordance with the present invention. The images of Figures 3a-3f and the following detailed description are presented only as examples of the types of passages which can be formed, and are not proposed to exhaustively describe all possible types of passages 10 which can be used in accordance with the present invention. Furthermore, it is to be noted that although the images of Figures 3a-3f are directed to the passageways 10 formed between a vein and an artery, the various modifications of the passageway illustrated in Figures 3a-3f are broadly applicable to any of all the types of extravascular catwalks 10 formed in accordance with the present invention, for which such modifications may be suitable. Actually, the passages 10 shown in Figures 3a-3f and described hereinafter are not limited to the passageways formed between the arteries and the veins, but can be broadly applicable to all passages 10 of the present invention. As shown in Figures 3a, the passages 10 of the present invention may comprise interstitial tunnels without small, uncoated tubes (Figure 3a). Alternatively, as shown in Figures 3b-3f, such passageways 10 can be provided with various types of surface modifications or auxiliary devices, such as tubular coatings (Figure 3b), clamps or longitudinal clamping jaws (Figure 3c), small tubes or small tube grafts which are confined within the passageway 10 (Figure 3d), or small tubes or grafts of small tubes which protrude outside and beyond passageway 10 (Figures 3e-3f). Referring specifically to Figure 3a, there is shown a passageway 10 which extends between two blood vessels and which is free of any small tube, coating, tubing, liner, valve, surface modification, substance or apparatus placed within the passageway. In this regard, this unmodified passageway 10, uncoated, without small tubes, is simply an interstitial tunnel (eg, a perforated tract or tunnel) which extends between two blood vessels so that blood can flow from the lumen of a blood vessel to the lumen of another vessel. Figure 3t shows a passageway 10 formed between two blood vessels and having a tubular inner liner 20 cclccadc therein. Such an internal coating 2C may comprise a segment of flexible or rigid plastic tubing, a layer of a bi-compatible polymeric coating, a layer of cells that differs from that surrounding tissue (for example, a. of the endothelial layer, etc., _r.-_ e-_p_ of tissue of modified density that can be signed by treatment of laser beam, electrocautery, etc., or any other type of material which di.ore of the inner surface of the passageway 1C without small and uncoated threads Such a covering 20 within the passageway 10 may serve to a) facilitate laminar and non-turbulent blood flow through passageway 1. cb) prevent unwanted closure of the passageway to the natural contraction of the muscle or surrounding tissue that has grown in the passageway 10. In the cases where the covering 20 is formed by the application of a material that can flow or energy (for example, a subst chemical chemistry to produce controlled chemical burning of the tissue or a biocompatible polymeric coating, a suspension of endothelial cells, etc ...) to the walls of the passage 10, the application of such material that can flow to the wall (s) of the passageway 10 can be effected through the use of a device such as that shown in Figures 8h-8h '' and described in greater detail subsequently, with reference to the devices of the present invention. Figure 3c shows a passageway 10 in which a longitudinal restriction apparatus 22 has been positioned to longitudinally compress the opposite ends of the passageway 10 toward each other, whereby any tees, for example loose connective tissue, are compacted. which is located between the blood vessels. Such longitudinal restriction apparatus 22 may also be constructed to provide radial support for, and / or to maintain the opening of passageway 10. The application of longitudinal compression to passageway 10 by a restriction apparatus 22 may be particularly important in applications of the invention wherein the blood vessels which connect the passageway 10 are located on the surface of an organ (for example, the epicardially located coronary artery and vein), or are otherwise located in such a way that the tissue cavernous or loose (for example, loose connective tissue) or open space, exists between the artery and the vein. The presence of such cavernous or loose tissue may allow blood to flow through the passageway 10 to infiltrate into such tissue or space between the artery and the vein, which may result in the formation of a hematoma. Examples of the specific types of restriction apparatus 22 which can be used to longitudinally compress passageway 10 for blood flow as shown in Figure 2c, or to otherwise facilitate the coupling of two blood vessels by anastamosis collateral, are shown in Figures 9a-9f, and are described hereinafter more fully, with reference to Figures 9a-9f. Figure 3d shows a passageway 10 of the present invention having a small non-protruding tube or graft with small tubes 24 placed within the passageway 10. Such a small tube or small tube graft 24 may comprise a small tube or self-expanding or expanding cylindrical structure. under pressure, and may optionally be covered by a continuous tubular member such as a collapsible segment of woven polyester or expanded polytetrafluoroethylene (ePTFE) the arrangement of such a small tube or small tube graft 24 within the passageway 10 may serve to maintain the passageway 10 in a substantially open configuration for facilitating non-turbulent blood flow through the passageway 10. The small tube or small tube graft 24 may be formed of any suitable material including, but not necessarily limited to, various types of intertwined strands or of wire mesh self-expanding or expandable under pressure, matt polymeric rial. In cases where a graft with small tubes 24 is used, the tubular graft covering the graft with small tubes 24 may be continuous or may be partial, such that only a portion of the small tube is covered. It will be appreciated that when a graft with protruding small tubes (e.g., covered small tube 26 or 28) is used, it may be unnecessary to additionally place additional embolization elements 12 within the lumen of the blood vessel within which the graft with small tubes 26, 28 extends, when the tubular outer envelope over the graft with small tubes will serve to define a closed flow passage through the lumen of this blood vessel and will substantially block the flow of endogenous blood through this portion of the blood vessel. , whereby the need for separate embolization elements 12 is avoided. Figure 3d 'shows the modifications of the small tube or graft with small tubes 24a to include a projection 25 and / or perpendicular projections 27 extending from one or both end (s) of the small tube or graft with small tubes 24a to keep the small tube or graft with small tubes 24a in a substantially fixed position within the passageway 10. Figure 3e shows a small tube or graft with small tubes 26 protruding or semi-protruding, which can be constructed in the same way as the small tube or graft with small tubes 24 not protruding, shown in Figure 3d, but which differs from that shown in figure 3d in that it protrudes or extends beyond from the ends of passage 10, towards the adjacent portions of artery A and the vein. When deployed like this, this small tube or graft with small tubes 26 will generally assume an "S" configuration, as shown in Figure 3e, to facilitate the non-turbulent, laminar flow of blood in the desired direction through the passageway. 10. The dotted lines on Figure 3e illustrate a "semi-outstanding" mode of the small tube or graft with small tubes 26 wherein one end thereof is at the same level as one end of the passageway 10, while the other end thereof extends towards the anatomical structure (i.e., the vein) adjacent to this end of the passage 10. Such "semi-outstanding" mode of the small tube or graft with small tubes 26 may be employed so as not to obstruct any blood flow that can be obtained through the artery A, and will be particularly applicable in patients in whom the OB obstruction is not complete, and in whom some of the arterial blood flow continued to pass through s of artery A. In other patients where the OB obstruction is complete, it may be appropriate to use the complete "protruding" mode of the small tube or graft with small tubes 26 where such a small tube or graft with small tubes 26 extends out from both ends of the passageway 10 to the adjacent anatomical structures (ie, the vein and the artery), as indicated by the dotted lines in Figure 3e. Figure 3f shows another small tube or graft with small protruding tubes 28, which extends fully through a first passageway 10a for blood flow and a second passageway 10b for optional blood flow, and which protrudes further to through the adjacent portions of artery A and vein V, whereby a continuous "U" shaped duct is formed through which non-turbulent, laminar blood flow can pass through both passages 10a, 10b . It will be appreciated that one or more valves may also be formed within any embodiment of the small tube or graft with small tubes 24, 26, 28 or within a tubular coating 20, or within a longitudinal restriction apparatus 22, or otherwise within the passageway 10, to facilitate the flow of blood in a desired direction (s) through the passageway (s) 10 while preventing or preventing backflow of blood to through the passage (s) 10 in the direction (s) opposite (s) to the desired address (es);?; iv. Transvascular Approaches to Form the Passage (s) between Two Blood Vessels Figures 4 and 4e and the following detailed description are provided for the purpose of illustrating some approaches which can be used to form extravasaral passageways between two blood vessels to carry out certain methods of revascularization of the present invention. The images of Figures 4a-4e and the following detailed description are not intended to exhaustively illustrate all possible approaches which can be used to form such passages 10, but instead are provided only as examples of the approaches currently perceived. of such procedures. In addition, although the images of Figures 4a-4e illustrate applications where an OB obstruction is present within one of the blood vessels, the general approach that is illustrated in these figures may be applicable to various revascularization methods wherein the catwalks are located in the blood vessels. they are formed for purposes other than bypass obstructions, or where CB obstructions are located remote from the locations at which the passage (s) 10 is formed. Furthermore, it will be appreciated that the approach that is illustrated in Figures 4a-4c need not necessarily be effected between two blood vessels or between an artery and a vein. Actually, these approaches may be applicable between any blood vessel or any other hollow anatomical structure, and may be usable for 1C passageway from vein to vein, from artery to artery or from vein to artery. Figure 4a shows a type of approach in which a catheter i 00 is transluminally advanced towards an artery A and a penetrating element 102 of the tissue is passed from the catheter 100 to form a first passageway 10a through the wall of the artery A, through a tissue located between artery A and vein V, and through the wall of the vein. After the first passageway 10a for blood flow has been created in this manner, a guidewire can be passed through the tissue penetrating element 102 or through the catheter 100, and through the first newly created catwalk 10a. After this, the penetrating element of the tissue is deactivated (for example, retracted towards the catheter 100), and the catheter is advanced over the guide wire, through the first passageway 10a, and toward the lumen of the vein, once that the site of the OB obstruction is passed in the adjacent artery A. After this, with the remote portion of the catheter positioned within the lumen of the vein, the penetrating element 102 of the tissue is once again advanced out of the catheter 100 to forming a second passage 102 for the flow of blood, which extends through the wall of the vein, any tissue located between the vein and artery A, and through the wall of Artery A. After this, the penetrating element of the tissue 102 can again be retracted towards the catheter 100 and the catheter can be retracted from the vasculature and out of the body. In this way, the approach shown in Figure 4a, performs the formation of a first passageway 10a for the blood flow upstream of the arterial obstruction OB and a second passageway 10b of the blood flow downstream of the obstruction. arterial. Figure 4b shows an alternative approach in which a catheter 100 is transluminally advanced towards the lumen of a vein, and the far end of the catheter is positioned adjacent to the location at which the first passage 10a for blood flow goes to be created After this, the penetrating element of the tissue 102 is passed out of the catheter 100 to form the first flow passage 10a for the flow of blood through the wall of the vein V, any tissue between the vein V and the artery A, and through the wall of artery A. After this, the penetrating element 102 of the tissue is deactivated (e.g., retracted towards the catheter 100), and the catheter is further advanced through the vein V to the far end of the catheter located adjacent to the location at which the second passageway 10b for blood flow is to be created. After this, the penetrating element of the tissue 102 is again passed out of the catheter 100, to form the second desired passageway 10b, through the wall of the vein V, and the tissue between the vein V and the artery A, and through the wall of artery A. After this, the penetrating element of tissue 102 is again deactivated (for example, retracted towards catheter 100) and catheter 100 can be removed from the venous vasculature and removed. In this way, the approach shown in Figure 4b effects the formation of a first passageway 10a for blood flow, downstream of the arterial obstruction OB and a second passageway 10b for blood flow, upstream of the obstruction OB, by transluminal catheterization and cannulation of the V vein only. Figure 4c shows another alternative approach where a catheter 100 is advanced transluminally to an artery A, and the remote end of the catheter 100 is positioned adjacent to the site in which the first catheter 10a for blood flow is to be formed . After this, the penetrating element of tissue 102 is passed out of catheter 100 to form the first passageway 10a for the flow of blood through the artery wall, any tissue between artery A and vein V, and Through the wall of the vein V. After this, the penetrating element of the tissue 102 is deactivated (for example, retracted towards the catheter 100) and the catheter is further advanced through the lumen of Artery A and passed through through the OB obstruction until the remote end of the catheter 100 is located adjacent to the site at which the second passageway 10b for blood flow is to be formed. Such advancement of the catheter 100 through the OB obstruction will typically require that a guidewire will initially advance through the OB obstruction to facilitate subsequent advancement of the catheter 100 through the OB obstruction. Such an initial step of a guidewire through the OB obstruction can be performed in cases where the OB obstruction is partial, or where the obstructive material is soft enough to allow a guidewire to penetrate through it. However, in cases where the OB obstruction is complete or formed of calcified plaque or other hard material, the approach shown in Figure 4c may be less than available and the operator will typically opt for one of the approaches shown in the drawings. Figures 4a or 4b in such cases. However, in cases where the catheter 100 has been successfully advanced through the OB obstruction as shown in FIG. 4c, the penetrating element of the tissue 102 will then be advanced back out of the catheter 100 to create the second catwalk 10b for the flow of blood through the wall of artery 10a, any tissue between artery A and vein V, and through the wall of the vein V. After this, the penetrating element of tissue 102 will be deactivated (for example, retracted towards catheter 100) and the catheter will be removed from the arterial vasculature and removed from the body. In this way, the approach shown in Figure 4c carries out the formation of a first passageway 10a for blood flow and a second passageway 10b for blood flow according to the present invention. Figure 4d shows another alternative approach where a catheter 100 is provided with a positive pressure pump 104, for pumping positive pressure fluid (eg, saline solution) through the catheter and out of a plurality of outlet openings 106 of positive pressure, formed in the body of the catheter 100 near the far end thereof. A nearby sealing element IOS (for example, a balloon which completely blocks the lumen of the blood vessel) is formed on the catheter, close to the ositi a pressure exit openings 106. A sealing element (eg, a balloon 110, remote, separate, is placed within the lumen of the vein V, slightly upstream of the site in, r, the second passageway 10b for the flow of blood v, _ = ¡ The catheter 100 is advanced through the lumen of vein V until the end remote from the catheter is positioned adjacent to the site in which the egun passageway 10b for blood flow is to be created. this, the proximal sealing element t is deployed (eg, deflated) to completely seal the vein V near the positive pressure outlet openings, 106 of the catheter 100. After this, the fluid under positive pressure (e.g. , salty solution) is passed through a lumen of the catheter and out of the positive pressure outlet openings 106, to cause the pressure P ± within the vein V to become high and, preferably, substantially equal to the average pressure P 2 within artery A. Such pressurization of the vein V lumen provides a viable method of identification of the presence of any SB venous side branches which may require ligation or attachment, closure or embolization to prevent any negligible inadvertent movement of blood from the recently created venous bypass line. Additionally, such pressurization of a lumen of the vein V can be maintained while the penetrating element of the tissue 102 is advanced out of the catheter 100, through the wall of the vein V and through the wall of the artery A to form the passageway 10 of the present invention. Such equalization of the pressure Pi within the vein V with the pressure F; inside the artery also serves to prevent any effusion or blood flow from the lumen of artery A to the lumen of the vein V when the catwalk 10 is created. Figure 4e shows another alternative approach where a first catheter 100 is advanced towards artery A, and a second catheter 100 is advanced towards the vein V. In some cases, the first and second catheters 100 will be advanced in directions generally opposite, as shown in Figure 4e. After this, the tissue penetrating elements 102 of the respective catheters 100 are used to form first and second passages 10a, 10b for blood flow, between artery A and vein V, as shown. After this, the penetrating elements of the tissue 102 will be deactivated (for example, retracted towards the catheters 100 and the catheters 100 will be extracted from the vasculature and removed from the body.) Thus, the approach shown in Figure 4e achieves the formation of first and second passages 10a and 10b for the flow of blood between the desired blood vessels, according to the present invention. v. Methods and Apparatus for Controlling, Guiding and Guiding a Tissue Penetrating Element and / or Auxiliary Devices Used to Form the Extravascular Catwalk (s) Figures 5a-51 show examples of the apparatus which can be used to orient, direct, control and / or guide the penetrating element of the tissue 102 when it is advanced from the catheter 100 of the present invention, to create the extravascular passageway 10 desired. In general, these orientation, direction, control and guidance apparatuses are proposed to place the catheter 100 in such a way that, when the penetrating element of the tissue 102 is passed out of the catheter 100, it will come into contact with and penetrate the wall. of the blood vessel within which the catheter 100 is placed. It will be appreciated that the drawings described in Figures 5a-51 and the following detailed description are provided only as examples of the types of orientation, direction, control and / or guidance apparatuses which may be used in the present invention, and they are not proposed to show or describe exhaustively all the possible devices which can be used for these purposes. In addition, it is to be understood that any or all of the apparatuses shown in Figures 5a-51 and described hereinafter, can be combined with any other element of the invention described herein to form a "system" by which the catheters can be used. The formers of the passages of the present invention can be oriented, directed, controlled or guided. Figure 5a shows an approach in which an active imaging device 50 is placed within the same blood vessel as the catheter 100 of the present invention. This active imaging device 50 can comprise any suitable type of imaging device carried by the catheter, including, but not limited to, an intravascular ultrasound device (IVUS catheter), a Doppler apparatus, an angioscope, etc. . In many cases, the active imaging device 50 will have a sensor (e.g., an ultrasound transducer, a sonic transducer, a trained image receiving lens, etc.) formed at a specific location thereon. Typically it will be desirable for such a sensor 52 to be located immediately adjacent to the location at which the tissue penetrating element 102 is introduced to the wall of the blood vessel to provide the desired observation, the direction and guidance of the tissue penetrating element 102. It will be appreciated that the active image forming device 50 may be mounted on or internally formed with respect to the catheter 100 forming the passageway, may be transported within a monorail or lateral stroller formed on catheter 100 (see Figs. 9-10), or it may be located within a discrete or completely separate catheter body, as shown in Fig. 5a. The embodiments of a catheter device 100 that forms the passageway, which incorporates means for mounting at least a portion remote from the active imaging device 50 within the catheter 100 that creates the passage, are specifically shown in FIGS. , and are hereinafter fully described with reference to such figures. An alternative approach for observing, directing and guiding the penetrating element of the tissue 102 is shown in Figure 5b, wherein the device for forming active images 50 is placed inside the blood vessel within which the penetrating element of the tissue 102 of the tissue will pass. 100 catheter that creates the catwalk. As shown in Figure 5b, the sensor 52 of the imaging device 50 can be located immediately adjacent to the site in which the passageway 10 is to be formed, such that the sensor 52 can direct and guide the penetrating element. of the tissue 102 when it extends from the catheter 100, to the sensor 52 of the active imaging device 50. Figure 5c shows another alternative approach which incorporates the use of a secondary imaging apparatus 54 (e.g. , a passive or coercive apparatus) in addition to the primary active imaging device 50. This secondary imaging apparatus can be formed on the catheter 100 that creates the passage, or on the penetrating element itself of the tissue, and is capable of of communicating with or being detected by the preliminary imaging apparatus 50. The primary imaging device 50, which has a sensor 52 located thereon, is located in the adjacent blood vessel as that in which the catheter 100 that creates the passageway is located. The active imaging device 50 will detect or communicate with the secondary imaging apparatus 54 to provide a direct means for observing, directing and guiding the tissue penetrating element 102. In this embodiment, the secondary imaging apparatus 54 can comprise any type of substance or apparatus which is interrogative, capable of forming an image, or otherwise discernible by the active imaging device 50. For example, the sensor 52 of the active imaging device 50 can they comprise a radiofrequency transmitter and the secondary apparatus of ícrr.ic é :. j images 54 on the catheter 100 that creates the passage, may comprise a transponder ae r s. - which can be interrogated by, and * t? t.r__ a response signal to, a radio signal at * -j by the radio frequency transmitter of the active imaging device 50. Alternately , in embodiments wherein the device for transferring active images 50 is a fluoroscopy, the intravascular ultrasound (IVUS) or Doppler device, the secondary imaging apparatus 54 on the catheter 100 forming the passage, can comprising a radiopaque marker, a reflection surface or an aperture for sound application from which the radiation, sonic or ultrasonic energy can be reflected back to the active imaging device 50. Examples of the types of apertures for the application of the sound or the surfaces that can be formed on the body of the catheter 100, or the penetrating element of the tissue 102 that will improve the visualization of the same by a device ositive of formation of active images 50, are described in the Patent of the United States of America nc. 4,977,897 (Hurwitz). Figure 5d shows a system in which the magnets 57a, 57b are mounted within the catheters 101a forming the modified passage zc, and are used in conjunction with a penetrating guidewire 103 of the tissue, having a sharp tip 107, for forming a passageway 10 between two blood vessels BVi, BV2 as shown, each of the catheters 101a, 101b have a magnet 5, 5 mounted on one side thereof. Each magnet, and adjacent inserts formed within the body of the catheter, have a hollow lumen 109 extending therethrough. In this manner, the lumenal openings in the magnets 57a, 57b can be placed in direct alignment with each other, using the attractive force of the magnets 57a, 57b to effect such aligned positioning. After this, the penetrating guidewire 103 of the tissue, having the sharp tip 107 sharp, can be advanced through the lumen 109a of the guide wire of the first catheter 101a and out of the lumenal opening in the magnet 57a of this catheter 101a , through the wall of the first blood vessel BVX, through any tissue located between the first blood vessel BVX, and the second blood vessel BV2, through the wall of the second blood vessel BV2 and towards the lumenal opening of the magnet 57b of the other catheter 101b forming the passageway. In this way, the penetrating guide wire 103 of the tissue will have a passageway 10 formed between the first blood vessel BV "and a second blood vessel BV2. It will be appreciated that the remote tip 107 of the penetrating guidewire 103 of the tissue may comprise a sharpened remote tip which is retractable toward the guidewire such that the guidewire GW can remain within the blood vessels after the catheters 101a, 101b have been removed. Alternatively, the penetrating guide wire 103 of the tissue may be a laser beam wire, a hot wire or any other type of tissue penetrating element suitable to form the desired passageway 10.
Figures 5e-5e '' 'show the methods and apparatus by which radiographic, passive, visible markers formed on a catheter 100 forming a passageway of the present invention can be used to effect the accurate rotating placement of the catheter 100 prior to the formation of each extravascular passageway 10. Figure 5e shows, schematically, a catheter 100 creating a passageway, placed within the first blood vessel BVi with the intention of forming a passageway 10 in accordance with the present invention, from the first blood vessel BVi to an adjacent T target (e.g., a body cavity, tissue mass or other blood vessel). A radiographic imaging apparatus 118 such as a fluoroscope or X-ray device is used to provide a radiographic image of the first blood vessel BVj, and the second blood vessel BV2 on a 120 mesh screen (for example, a light cassette). X or fluoroscopy screen). Figure 5e 'shows a catheter 100 having radiographically visible (eg, radiopaque or radiotransparent) markers 112a, 122b formed at locations spaced apart longitudinally on opposite sides of catheter 100. These radiographically visible markers 122a and 122b are preferably in positions of elevation equivalent in relation to the height H of the catheter 100, but are spaced apart longitudinally, as shown. Accordingly, the precise rotational positioning of the catheter 100 can be achieved by causing these radiographically visible markers 122a, 122b to become aligned directly on the screen 120 in equivalent elevation positions, as shown in the lower side box of Figure 5e ' Figure 5e '' shows another type of passive marking system which can be used to achieve the precise rotational positioning of the catheter 100. With reference to figure 5e '', the catheter 100 forming the passageway has a radiographically visible marking 124 circular, on one side and a radiographic marking 126 in the shape of a disc or dot, on the other side, directly opposite the circular marking 124. In this way, the precise rotational positioning of the catheter 100 can be achieved by causing the marking 126 in the form of a disc or point becomes placed within the circular marking 124, as seen on the screen 120. This is illustrated in the lower side box of Figure 5e '. Still another type of radiographically visible marking which can be used to achieve the precise rotational positioning of the catheter 100 is shown in Figure 5e '' '. Referring to Figure 5e '' ', a catheter 100 having two (2) radiolucent openings 128a, 128b of substantially equivalent size, formed one directly opposite the other, on opposite sides of catheter 100 is provided. , the precise rotational positioning of the catheter 100 can be achieved by rotating the catheter 100 until the first and second radiolucent openings 128a and 128 appear as a single opening when viewed on the screen 120, as illustrated in the side box of the figure 5e '' '. Figures 5f-5f show the manner in which an ultrasonically visible marking 130 formed on the catheter 100 of the passageway formation can be used in conjunction with a transducer 132 for extracorporeally placed ultrasound imaging to perform the orientation Precise rotating of the catheter 100. As shown, the visible marker 130 is aseonically formed at a specific location on the catheter 100, such that the specific location has a known relationship to the site and direction in which the penetrating element of the tissue 102 will pass from the catheter 100. The ultrasound imaging transducer 132 is placed on the body to form images both on the blood vessel BV_ where the catheter 100 forming the catwalk is positioned as on the target or target ( for example, the second blood vessel, the tissue mass, or another target or target location) within which the penetrating element of the tissue 102 of the catheter 100 is to be passed. After this, the catheter 100 is rotated until the ultrasonically visible marking 130 is formed as a clear and complete image by the transducer 132. Such placement of the ultrasonically visible marker 130 serves to establish that the catheter has been placed in its orientation rotationally suitable for causing the penetrating element of the tissue to pass toward the target or objective T. Figures 5g-5g '' illustrate the manner in which the passive markers on catheter 100 forming the passageway are used in conjunction with a system of magnetic resonance imaging (MRI) for performing the precise longitudinal and rotational positioning of the catheter 100 as well as for the determination of ia d ._ - - p:; a between the blood vessel in which the catheter 1? is located and the target or objective T, to pre-erect a means to determine the distance which iet < - • being traversed by the penetrating element of the tissue 1 U to form the desired passageway between the blood vessel BV. and the target or objective T. In this embodiment, the catheter body 100 is formed of a material which is visible by MRI. Additionally, the discrete MRI marker 134 is formed on the catheter body, at a specific location. The label can comprise an induction coil 134a or a small mass of material 134b which differs from the material of which the body 100 of the catheter is formed so that it is specifically visible on the MRI. With specific reference to FIG. 5g ', the induction coil 134a is positioned on or within the wall of the catheter 100 at a specific location, and is connected by the wires 135 which extend through the catheter to an external location on the catheter. where they can be connected to a suitable current source, oscilloscope and / or other verification system by which the current, phase and amplitude of the electromagnetic field within the coil 134a can be verified. In this way, the movement of the ICO catheter within the MRI scanner 135 will cause the location of coil 134a to be altered within the variable but known magnetic field created by the MRI system. In this way, each movement of the catheter 100 within the MRI field causes a change in current, phase and amplitude. The information of the phase and the amplitude of the current received from the coil 134a can then be used to determine the precise location of the coil 134a relative to the target or target T.
Furthermore, if the coil 134a becomes located outside the specific plane which is being formed in its image by the MRI scanner 135, this will indicate that the catheter 100 has been moved longitudinally out of the desired plane. In this way, coil 134a can be used for the precise, and rotational, longitudinal orientation of catheter 100. In addition, the information received from coil 134a can be used to determine the distance extacted between coil or spool 134a and target T by means of which information is provided that will enable the operator to control the penetrating element 102 of the fabric in a manner consistent with the length of the passageway 10 to be formed. With specific reference to Figure 5g '', an alternative MRI marker 134b, comprises a discrete mass of material which differs from the body material 100 of the catheter, and which is visible on the MRI. In this way, the visible MRI marker 134b can be observed precisely * on the MRI image, and can be used to visually adjust the longitudinal or rotational orientation and place the catheter 100 relative to the target or T objective. Also, the distance observed between the marker 134b and the target or objective T can be used to make it possible for the operator to control the passage of the tissue penetrating element 102, to create a passageway 10 of the desired length between the blood vessel BVi within which the tissue is located. catheter 100 and target or target T. Specific examples of the "active" imaging apparatus which may be associated with, mounted on or incorporated in catheter 100 that forms the passage, to facilitate accurate rotational orientation of catheter 100 Within a blood vessel, they are shown in Figures 5h-51. With reference to Figure 5h, a type of active image forming apparatus which may be associated with, mounted on or incorporated in the catheter 100 forming the passageway, is a Doppler apparatus 136, such as that which is incorporated in a commercially available device, known as Smart Needle, Cardiovascular Dynamics, Inc., Sunnyvale, California. With reference to Figure 5h, the Doppler apparatus 136 is mounted on or within the catheter 100 and is oriented or directed in a lateral direction (eg, perpendicular) to the longitudinal axis of the catheter 100. The Doppler apparatus 136 is usable for locating and discerning a flow of fluid or other material within the target or target T. Therefore, the embodiment shown in figure 5h is usable when the target or target T comprises a blood vessel or other anatomical structure where the fluid or other material is flowing . The amplitude of the signal provided by the Doppler apparatus 136 and other information discernable therefrom makes it possible for the operator to: a) longitudinally position the catheter in such a way that the Doppler apparatus 136 is forming the image of the flow characteristics desired with the target or T target (eg, downstream of an obstruction and an artery), b) rotate the catheter so that the amplitude of the Doppler signal is converted to a maximum to indicate that the Doppler device 136 is oriented precisely at the flow center within the target or T target (eg, the lumen center in a blood vessel) and c) determining the distance between the Doppler apparatus 136 and the center of the flow within the target or target T. Such determination of the distance between the Doppler apparatus 136 and the center of fiow, for example, the center of the lumen, within the target or target T will make it possible for the operator to control the element. or tissue penetrant, such that tissue penetrating element 102 will pass or extend only to the desired distance from catheter 100, but a passageway 10 is formed in the flow center (eg, lumen). ) of the target or target, but that does not travel too far so that it could puncture or perforate the contralateral side of the target or target T. After the catheter 100 has been placed in the first BVl blood vessel the Doppler device 136 will be activated and the catheter 100 will be moved longitudinally and / or rotated until the Doppler signal is indicative of the desired flow within the portion with the image formed of the target or target T and such that the amplitude of the Doppler signal has been a maximum, which indicates that the Doppler apparatus 136 has been directly aligned with the target or target T. After this, the output of the Doppler Apparatus frequency 136 can be varied and the frequency which produces the maximum amplitude response will indicate the distance from the Doppler device 136 to the target or objective T. In this modality, the target or objective T must be a blood vessel or other anatomical structure where the flow of the material is present, so that it is discerned or detected by sonic means (for example, the Doppler). Fig. 5i shows a modality in which an intravascular ultrasound imaging apparatus 138 is placed over the catheter 100 forming the passageway, at a specific location on one side of the catheter 100. Such a specific location of the catheter forming apparatus. ultrasound images 100 is preferably at a known linear distance and at a known rotational distance away from the location at which tissue penetrating element 102 will pass out of catheter 100. After catheter 100 has been placed within the first blood vessel BVi, the catheter 100 can be rotated until the target or T target (eg, blood vessel, pulsating tissue, or other locations of the target or target visible by ultrasound imaging) is in direct alignment, and its image directly by the ultrasound apparatus 138, whereby it is indicated that the catheter 100 has been oriented longitudinally dinally and rotatably to cause the penetrating element 102 to pass through the wall of the first blood vessel BV; and towards the target or objective T, as proposed. Figure Sj. illustrates the manner in which a first transmitter / receiver wire 140a and a second transmitter wire 14r can be used to effect the precise rotational orientation of the catheter 100 that forms the passageway. As shown, the first transmitting wire or receiver i 0a is positioned in or within the wall of the ICC catheter which forms the passageway at a specific location on one side of the catheter 100. The location of this transmitting or receiving wire 140a is preferably immediately adjacent to the location at which the penetrating element of the tissue 102 will exit the catheter 100. A second transmitting wire or receiver 140b is placed within the target or target T (eg, the second blood vessel, the tissue of target or target or other location within which the penetrating element of the tissue of the catheter 100 forming the passageway is to be passed). After the catheter 100 has been advanced towards the first blood vessel BVi, the catheter will be rotated while a signal is emitted from a transmitter or receiver wire 140a, 140b so that such signal can be received by another transmitter or receiver wire 140a, 140b. In this way, the catheter can continue to be rotated until the amplitude of the signal received by the transmitting / receiving, receiving wire 140a, 140b is converted into a maximum, whereby it is indicated that the first transmitter / receiver wire 140a and the second transmitter / receiver wire 140b are at their closest point, which indicates that the catheter 100 has been placed in its desired rotational orientation within the first blood vessel BV .. Additionally, one or both of the receiver wires 140a, 140b can be placed in blood vessel BV. The target area and / or the target area T performs the desired longitudinal cranking of the catheter 100 within the blood vessel BVj., when the signal verified between the wires 140a, 140b so indicates.
Figure 5k shows an alternative arrangement wherein the induction coil 142 is formed on or within the wall of the catheter 100 that forms the passage, at a specific location which corresponds to the site from which the tissue penetrating element 102 will exit from the catheter 100. A transmitter wire 144 is positioned within the target or target T (eg, the second blood vessel, the target tissue or other location within which the penetrating element 102 of the catheter tissue 100 is proposed to pass. ), the transmitter wire 144 is energized to emit an electromagnetic signal and the induction coil 142 is also energized. After this, the catheter 100 is rotated until the phase and the amplitude of the signal within the induction coil 142 indicate that the induction coil 142 is at its closest point to the transmitter wire 100, for which it is confirmed that the catheter 100 has been placed in its proper rotational orientation to cause the tissue penetrating element 102 to pass from the catheter 100, through the wall of the first BVi, and toward the target or objective T. Figure 51 illustrates the manner wherein the first and second magnets 146a-146b can be used to effect the precise rotational orientation of the catheter 100 that forms the passageway. The first magnet 146a is positioned on or within the wall of the catheter 100 that forms the passage, at a specific location which corresponds to the site from which the tissue penetrating element 102 will exit the catheter 100. The second magnet 146b is placed on a second catheter 148 which is inserted into the target or target T (eg, the second blood vessel, target tissue or target or other location within which the tissue penetration element 102 is to be passed). The catheter 100 forming the passageway is then rotated, or allowed to auto-rotate) until the first magnet 146a and the second magnet 146b are in alignment with and are as close as possible to each other, whereby it is indicated that the catheter 100 forming the passageway has been placed in its correct rotational orientation to cause tissue penetrating element 102 to pass through the wall of the first BVL blood vessel and into the target or objective T.
B. Devices of the Present Invention Figures 6 to 12 show the devices of the present invention which are usable to form the extravascular passages 10 according to the present invention, or to modify or otherwise equip such passages 10. It is to be appreciated that the images of the Figures 6-12 and the detailed descriptions described hereinafter are intended to describe and illustrate only certain examples and currently preferred embodiments of the devices, and are not intended to list and exhaustively describe all possible devices or modalities in which this invention can take a physical form. i. Outlet Schemes to Facilitate the Passage of the Penetrating Element of the Tissue, Outside the Catheter Body Figures 6a-6i show the examples of arrangements and apparatuses by means of which a penetrating element 102 can be used to initially form an extravascular passageway 10 of the present invention, can be passed outside the catheter 100 forming the passageway , placed within the lumen of a blood vessel such that the penetrating element 102 of the tissue will pass through the wall of the blood vessel in which the catheter 100 is placed, to create the desired extravascular passageway 10. The detailed description of Figures 6a-6i described hereinafter refers to the various types of penetrating elements 102 of the fabric. The term "tissue penetrating element" as used herein is intended to encompass all possible types of elongated elements which can be used to penetrate the tissue, devices or devices which can be used to penetrate tissue, or energy flows (eg, heat, laser beam, etc.), which can be used to penetrate the tissue. Accordingly, when it was established that the tissue penetrating element 102 is "passed" out of the catheter 100, such a foundation will not necessarily involve the passage of a solid element from the catheter body, but may also include the operation of an apparatus penetrating the tissue or passing an energy flow (eg, heat, or a laser beam) from the catheter body in a manner and in a direction which will create the desired extravascular passageway 10. In addition, it will be appreciated that the images of Figures 6a-6i and the description provided in conjunction with such figures is not intended to describe or illustrate all possible arrangements or apparatuses by which the penetrating elements of the fabric 102 can be passed through. outside the catheters 100 forming the passageway of the present invention. Additionally, the following detailed description refers to some penetrating elements 102 of the fabric, which comprise a "pre-bent elastic element". The term "pre-bent elastic element" will mean an element which, when not under tension, will assume a curvilinear configuration but which is sufficiently flexible to be urged towards and subjected to tension by a lumen of catheter device 100 without causing deformation Elastic element. Examples of the materials which can be used to form the pre-bent elastic elements usable to form some of the penetrating elements 102 of the fabric, of the present invention, include the materials which are flexible, elastic or superelastic at body temperature and within the range of other temperatures under which the device will be used. The extruders of these materials include some stainless steels, some plastics, and certain superelastic metal alloys and polymers such as nickel and titanium alloys. Figure 6_ is a mode of the catheter 100a that forms the lumen, wherein a lumen 112a extends longitudinally through the catheter 100a and ends remote from an aperture 114 of the far end. The penetrating element 1C2 of the fabric comprises an elastic element, predcbiado, as defined here above. When retracting within lumen 112, this embodiment of the penetrating element of tissue 102 assumes a configuration that is not bent or minimally bent, substantially straight, according to the surrounding wall of catheter 100a. However, when the penetrating element of the tissue 102 is advanced out of the exit opening 114a at the far end of the catheter 100a, the tissue penetrating element 102 will assume its pre-bent configuration such that the far end of the penetrating element 102 of the tissue, will penetrate through the wall of the blood vessel where the catheter 100a is placed. It will be appreciated that with respect to this embodiment, and all other embodiments of the invention described herein, the penetrating element of the fabric 102 can be configured to form any desired shape and size of the passageway 10. Therefore, in the embodiments where the penetrating element of the fabric comprises a pre-bent elastic element, the pre-bent configuration of the penetrating element of the fabric can be continuous, partially straight and partially curvilinear, multicurved, c any other pre-bent configuration which is suitable for forming the extravascular passageway. initial, of the desired shape and size. Furthermore, as will be discussed in greater detail hereinafter, various passageway modifying devices may be used to unload, enlarge, dilate or otherwise modify the size and / or shape of the passageway such that the resulting final shape of the passageway 10 may differ substantially from that which is initially created by the first penetration of the tissue penetrating element 102. Figure 6b shows a catheter device 100b that forms a catwalk, having a lumen 112 extending longitudinally from start to finish and ending away from an exit opening 114b of the side wall. A baffle surface 115 is formed within the lumen 112b, between the opening of the side wall 114b, and the collateral surface of the lumen 112b. A tissue penetrating element 102, formed of a collapsible material, is of a substantially straight configuration when retracted into the lumen 112b. However, when advancing in the direction of withdrawal, the far end of this penetrating element 102 of the tissue will be deflected by the baffle surface 115, and will exit the catheter body 100b through the opening 114b of the side wall. In this way, the penetrating element of the tissue can be caused to exit the catheter body 100b in a lateral direction relative to the longitudinal axis LA of the catheter 100b. Figure 6c shows a catheter device 100c having a lumen 112c extending longitudinally therethrough and ending away from an exit opening 114c of the side wall. The tissue penetrating element 102 may be a pre-bent elastic element and is of a substantially straight configuration when it is completely retracted into the lumen 112c of the catheter 100c. However, when this penetrating element 102 of the fabric is advanced in the away direction, the far end of such pre-bent elastic element 102 will self-locate and pass out of the exit aperture 114c due to its inherent tendency to look for its pre-bent configuration, there is no need for butt contact against or deflection from any surface of lumen wall 112c. Figures 6d and 6d 'show a 100OO catheter device which has a lumen 112d extending longitudinally therethrough and ending at an exit aperture 114d of the far end. An anvil member 180 is mounted at a distance spaced forward of the distal end of the 100OO catheter, and is secured to the catheter by means of integrally formed posts 182. The anvil member 180 has a dull remote distance 184, and a baffle surface 186 formed on the proximal side thereof, in direct alignment with the exit aperture 114d of the end remote from lumen 112d of the 100d catheter. The tissue penetrating element 102, in this embodiment can comprise either a collapsible or elastic element, the pre-bent element which assumes a substantially straight or minimally bent configuration, which conforms to and is retractable towards the lumen 114d of the catheter, as is shown However, the puncturing element 102 is advanced outside the opening 114d of the end remote from the catheter, the tip away from the penetrating tissue element 102 will abut against the deflecting surface 186 of the anvil element 180, and will be deflected, guided , by means of this, or it is caused to flex or bend in the lateral direction, so that the penetrating element of the tissue will pass through the wall of the blood vessel BV, as shown. Preferably, the baffle surface 186 of the anvil element 180 is not continuous with the inner surface of the lumen 112d of the catheter 100d. Figure 6e shows another embodiment of the 100OO catheter device wherein the 100OO catheter device comprises ur. liner 190 of the catheter, external, retractable, and an elongate internal member 192 having an elastic tube 194, pre-folded, formed within or mounted within the remote portion thereof. The elongated inner member 192 has a dull-tipped end 196 and an elongated lateral opening 198 formed therein, so that when the liner 190 of the outer catheter is retracted in the proximal direction, the pre-bent elastic tubular member 194 will flex outwardly. until its configuration curves laterally, pre-bent, as shown. The tissue penetration element 102, of this embodiment, can be a foldable element or a pre-bent elastic element which will assume a pre-bent configuration when it is advanced outwardly of the opening ll.e of the remote end, formed at the end of the inner tube element 194. Of this In this manner, the pre-bent tube element 194 can form a first angle Ai when the liner 190 of the catheter is retracted in the proximal direction, and the elastic tissue penetrating member 102 can form a second additional angle A2 when it is made advancing outwardly from the opening 114e of the end remote from the pre-bent pipe element 194, such that the first angle Ai and the second angle A2 will combine to form a third resulting angle A3 between the direction in which the tip is remote from the element 102 penetrant of the tissue is oriented and the longitudinal axis LA of the catheter 100%. As explained in detail here above, the angle A3 between the direction of the tip away from the tissue penetrating element 102 and the longitudinal axis LA of the 100OO catheter does not necessarily dictate or define the precise angle at which the passageway 10 will be formed by the element. 102 of tissue penetration. Actually, the penetrating element 102 of the fabric can be of any suitable configuration, including a continuous curvilinear configuration which will create a continuous curvilinear passageway. Figure 6f shows another embodiment of the catheter device lOOf, wherein the catheter device lOOf comprises a tubular outer liner 202, which is retractable in the proximal direction, and an elongate internal member 204 having a dull tip 206 and a retractable tip 206. side opening 208 formed therein. The tissue penetrating element 102 is preferably a pre-bent elastic element mounted within the elongated element 104, immediately adjacent to the side opening 208 such that, when the liner 202 of the external catheter is advanced so as to cover the lateral engagement 208, the penetrating element of the fabric 1 U will assume a configuration substantially rec "minimally bent to conform to, and ar-. q._e is contained within the internal lumen 112: ae_ catheter device lOOf. However, when the outer ferr 202 is withdrawn in the proximal direction to expose the lateral opening 208, the tissue penetrating member 102 will flex outwardly to a pre-bent configuration such that the far end of the penetrating member of the fabric will be directed to or will be placed in immediate contact with, the wall of the container BV within which the catheter device 100OO is inserted. In at least some embodiments, the penetrating element of the tissue can be advanced in the away direction to penetrate through the wall of the snail vessel and through any extravascular tissue required to form the extravascular passageway 10 according to the present invention. Figure 6g shows yet another embodiment of a 100OO catheter device forming the catwalk, comprising a tubular catheter body having a hollow lumen 112g extending longitudinally therethrough and opening as it moves away through the catheter. an opening 114g of the far end. The remote end of the lOOg catheter body can be bent in a lateral direction, as shown in the dotted lines of Figure 6g. Such extreme bending away from the catheter device l.Oa in the lateral direction, will cause the exit aperture 114g to be directed towards the wall of the blood vessel within which the lOOg catheter device is positioned, such that the Subsequent advancement of the tissue penetrating element 102 out of the opening 114g of the far end of the 100g catheter device will cause the penetrating tissue element 102 to contact and pass through the wall of the blood vessel BV within which it is placed. the lOOg catheter device. The fold-away end of the lOOg catheter can be caused to transition from its straight configuration to its curved configuration or bent by the presence of an alloy of shape memory, a pull wire, opposing electromagnetic coils or any other mechanism, apparatus or suitable material, which is known in the art to cause the tip of a catheter to bend. Figure 6h still shows another embodiment of a catheter device forming a 10000 catheter comprising a tubular catheter lOOh having a tissue penetrating element 102 that can pass therethrough. An inflatable balloon 210 is formed on one side of the catheter device 10000, opposite the location in which the extravascular catheter 10 is to be formed in the blood vessel BV. Inflation of the balloon 210 prior to or during advancement of the tissue penetrating element 102 will: a) prevent or prevent the 10000 catheter from being wound and pressed against the collateral wall of the blood vessel BV when the tissue penetrating member 102 is advanced to Through the wall of the blood vessel BV, and b) it may operate to stabilize and retain the remote portion of the catheter device lOOh in a substantially fixed position within the lumen of the blood vessel BV, to allow the application of an improved force or pressure on the penetrating element 102 of the tissue when it is advanced and passes otherwise through the wall of blood vessel BV. In the embodiment shown in Figure 6h, the catheter device has a distal end opening 114h and the tissue penetrating element 102 is a pre-bent elastic element which will assume a curved or bent configuration when it leaves the opening 114h from the far end. It will be appreciated, however, that the side balloon 210 shown in Figure 6h can be incorporated and used in conjunction with any of the types of the catheters shown in Figures 6a-6i, including those in which the penetrating element of the tissue comes out at through a lateral outlet opening formed in the side wall of the catheter device 10000. FIG. 6i shows yet another embodiment of a 100I catheter device forming a passageway, comprising a flexible, elongated tubular catheter body having a hollow lumen 114i extending therethrough and a blunt tipped element 212 rotatably mounted on the remote end of the tubular catheter body. The element 212 of the remote tip has a curved lumen 214 extending therethrough, the proximal end of which is in alignment with lumen 114i of the 100OO catheter, and the far end of which terminates in a lateral exit opening. 114 i formed on one side of the remote tip element 112. The tissue penetrating element 102, in this embodiment may comprise a folding element or a pre-bent elastic element. In any case, the tissue penetrating element 102 can be initially advanced to an intermediate position where the tip remote from the tissue penetrating element is positioned within the curved lumen 214 of the remote tip element 212. With the tissue penetrating element 102. in such an intermediate position, the tissue penetrating element 102 can be rotated. The rotation of the penetrating element 102 of the fabric, due to its frictional engagement within the curved lumen 214 of the remote tip element 121, causes the remote tip element 212 to rotate concurrently. In this manner, the partial advancement and rotation of the tissue penetrating element 102 can be used as a means to rotationally move the remote tip element 212 to adjust the rotational orientation of the side exit aperture 114i to direct the penetrating element. of the tissue in the desired lateral direction to form the extravascular passageway 10 of the present invention at the desired location. In this way, the further advancement of the tissue penetrating element 102 out of the side exit aperture 114i, after the desired rotational orientation of the remote tip element 212 has been achieved., will cause the penetrating element of the tissue to form the desired extravascular passageway 10 through the wall of blood vessel BV within which the catheter device 100i is placed. ii. Types of Tissue Penetrating Elements which can be incorporated into the Catheter that forms the Catwalk The following figures 7a-7m and the accompanying detailed description described hereinafter are intended to describe and illustrate some types of tissue penetrating elements 102 which may be used in accordance with the present invention. It will be appreciated and understood that the specific types of tissue penetrating elements 102 described hereinafter and shown in Figures 7a-7m are not intended to list and exhaustively explain all possible types of penetrating elements 102 of the tissue which may be Usable, but, instead, are proposed to provide examples of the types of tissue penetrating elements 102 which may be used. As explained hereinabove, the term "tissue penetrating element" is not limited to solid elements but also includes various devices, apparatuses, or energy flows. In addition, the term "pre-bent, elastic element" should be interpreted in accordance with the definition of such term as described hereinbefore. With reference to Figures 7a-7m, various types of tissue penetrating elements 102 are shown which can be incorporated into catheter 100 forming the passageway of the present invention. These penetrating elements 102 of the tissue are designed to pass out of a flexible catheter body and to penetrate through the wall of the blood vessel within which the catheter 100 is located, and to adjust the adjacent extravascular tissue, when necessary, to forming the desired avascular extense passage 10 of the present invention. The figures "a" and "a" show a first embodiment of a tissue piercing e-errt.106.This embodiment of the penetrating fabric e.erer.t ^ lC2a comprises an elongated foldable needle, formed of a foldable material tl; ", A polyimide pipe of the commercially available type, and having a sharp, beveled, tapered tip 300 formed thereon, An optional lumen 302 may extend longitudinally through the penetrating element 102a. is positioned longitudinally within the tissue penetrating element 102a, or alternatively a pull wire When the element 102a is retracted into the lumen of the catheter 100 which forms the passageway, the elastic spine element 304a will be caused to assume a substantially straight configuration or minimally bent which conforms to the lumen configuration of the catheter and allows the penetrating element 102a of the tissue to be fully retracted I enter the lumen of the catheter. However, when the penetrating element of the tissue is exposed or advanced outside the catheter 100 forming the passageway, a portion remote from the pre-bent spine element 304 will bend or flex in a lateral direction, whereby the element is caused to 102a, tissue penetrating, foldable, complete, assumes such curved configuration and laterally bent, as designated by the interrupted lines on Figure 7a. In this way, the pre-bent elastic spine element 304 will cause the flexible or foldable body of the tissue penetrating member to assume the desired curved or bent laterally configuration. In some cases, this arrangement may also allow the collapsible body of the tissue penetrating element 102a to be rotated or wound around the pre-bent elastic spine element 304a to facilitate or improve the advancement of the tissue penetrating element through the wall of the blood vessel. or of the adjacent tissue. Figure 7b shows another embodiment of a tissue penetrating element 102b which comprises an elongated, foldable, proximal shaft 306, having a sharp, remote tip element 308, rigid, mounted on, or otherwise attached to the far end of the proximal shaft 306. In this modality, the proximal axis 306 of the tissue penetrating element 102b is sufficiently foldable and unible to navigate tortuous anatomical curves or curves within the lumen of a catheter, while the portion 308 of the rigid remote tip is formed of a rigid material, such as stainless steel, to maintain a substantially sharp remote tip 310, which will penetrate and pass through the wall of the blood vessel and the desired extravascular tissue, to form the extravascular passageway 10 in accordance with the present invention. Figure 7c shows another embodiment of a tissue penetrating element 102c which comprises an elongated hollow or solid needle, having a sharpened remote tip 312, and formed of a pre-bent elastic material such as a superelastic nickel-titanium alloy or other alloy metal which exhibits flexible, elastic or superelastic properties within the temperature range which the penetrating element 102c of the fabric will encounter during normal use. This embodiment of the tissue penetrating element 102c, which is formed of a pre-bent elastic material, will assume a substantially straight or minimally flexed configuration when retracted towards the lumen 112 of the catheter 100 forming the passage, such that the penetrating element 102c tissue may be retracted into the lumen 112. However, when the tissue penetrating element 102c is advanced outside the exit opening 114c in the catheter 100, the tissue penetrating element 102c will assume its pre-bent configuration to become curved or bent in the lateral direction at an angle A relative to the longitudinal axis LA of the catheter, whereby the advance of the remote portion of the tissue penetrating element 102c through the wall of the blood vessel and through any adjacent tissue is facilitated. forming the desired extravascular passageway 10 according to the present invention. Figure 7d still shows another embodiment of a tissue penetrating element 102d comprising a hollow needle having a sharp (eg, bevelled) tip 314, and a lumen 316 for the passage of the guide wire, which extends longitudinally through of the same. It will be appreciated that this hollow needle can be formed of any collapsible material or elastic material, pre-folded, according to various outlines of the tissue penetrating element, illustrated in Figures 6a-6i and described in detail here above. The embodiment of the pricking element 102d shown in Figure 7d has the advantage of allowing a guide wire GW to be advanced through the lumen 316 of the guidewire. In this way, the guide wire GW can be periodically advanced in the remote direction or it can be placed under pressure directed to remote, continuous control, such that, when the sharpened remote tip 314 of the penetrating element 102d of the fabric is introduced. to the lumen of another blood vessel or another hollow cavity, the guidewire GW will rapidly advance in the direction of retraction, whereby signals will be sent that the sharpened remote tip 314 of the tissue penetrating element 102d has been inserted into such lumen of the vessel blood or hollow cavity. Accordingly, this embodiment of the penetrating element 102d is particularly usable in the revascularization methods of the present invention wherein an extravascular passageway 10 is formed between two blood vessels, c in other extravascular procedures of the present invention wherein the extravasation passageway 10 goes to be formed between a blood vessel and a target or target T which comprises another blood vessel or another hollow cavity of the body. The remote-controlled pressure on the guide wire GW can be applied manually or by means of a pressure-releasing safety apparatus, of the type shown in figures 10c ', 10c' 'and 10c' '' and described hereinafter in full . Figure 7e still shows another embodiment of a tissue penetrating element 102e comprising a solid needle having a sharp pointed tip (e.g., bevelled) 318. This embodiment of the piercing or puncturing element 102e may be formed of a continuous solid elongate element, such as a wire, as illustrated in Figure 7e '. Alternatively, as illustrated in Figure 7e '', this embodiment of the tissue penetrating element may comprise an outer tubular element 102e '' having a hollow lumen 114e '' extending longitudinally therethrough, and a stylet element. removable solid 320, coaxially inserted into the hollow lumen 114e '' of the penetrating element 102e '' such that the tubular penetrating element 102e '', in combination with the solid stylet element 320, will essentially form a solid needle structure similar to the elongated piercing or puncturing element 102e 'shown in Figure 7e'. Figure 7f shows still another embodiment of a tissue penetrating element 102f which is composed of the combination of an elongated tubular or solid element 322, having a sharpened trocar tip 324 formed on the far end thereof, and an outer lining 326 that can be advanced longitudinally. The remote portion of the outer liner 326 can be sharpened, not shown, so that it can pass over and protect the sharp trocar tip 324 of the elongated element 322. However, when it is advanced through the wall of the blood vessel or other tissue, the sharpened trocar tip 324 will exit out of the opening of the end remote from the outer liner 326 to penetrate and advance through the wall of the blood vessel and / or other tissue. When the trocar tip has passed into another blood vessel lumen or other hollow body cavity, the outer liner 326 can be advanced in response to the continuous, intermittent, distance directed pressure applied to the outer liner 326. Such prestir, directed at a distance can be applied manually by means of a safety device which exerts a continuous pressure of the type shown in figures 10c ', 10c' 'and 10c' '', as described more closely. here later. Figure 7g shows still another embodiment of a tissue penetrating element 102g which comprises an elongated tubular element 328 having a remote tip 330 emitting energy, formed on the far end thereof. One or more elements or wires 332 for energy transmission, may extend through the tubular element 328 and be connected to the remote tip 330 which emits energy, to supply the desired form of energy to the far tip 330. Of this Thus, the remote tip that emits energy can emit any type of energy which will ablate, cut or facilitate the advancement of the element 328 through the blood vessel and other extravascular tissue, according to the methodology of the present invention. Examples of the types of energy that can be emitted from the aleute tip 33C that emits energy include heat (for example, the heat of an electrical resistance or the heat of a laser beam to form a "hot tip").;, monopolar electrocautery, bipolar electrocautery, ultrasound, etc. Figure "* h shows yet another embodiment of a penetrating tissue IGSh element comprising an aiargae flexible catheter: 10C having a lumen 112 extending lengthwise from beginning to end and a tip 336 forming a rotating passage, mounted on the remote end thereof A rotary pulse element 338 extends longitudinally through the lumen 112 of the catheter 100, and operates to rotate the remote tip 336 when it is desired to advance the penetrating element 102h through the wall of the tissue. a blood vessel and other tissue The rotatable remote tip 336 may be of any suitable configuration which, when rotated, will form a tunnel or passageway through the tissue of the desired configuration.In this regard, the outer surface of the tip Rotary 336 may be provided with a threaded element or sharp spiral blade 337 or other suitable tissue dilation or cutting apparatus to facilitate the piercing rotating, cutting or delaying the desired tissue of the rotary tip 336. FIG. 7i shows yet another embodiment of a tissue penetrating element 102i. In this embodiment, the tissue penetrating element 102i comprises a continuous or pulsating laser beam of light, which is projected out of an aperture or door covered with a lens 114i formed in the catheter 100. A laser beam transmitting element 340 such as the optical fiber extends longitudinally through the lumen 112 of the catheter 100, and ends close to and in alignment with a reflective surface 341, such as a mirror, from which the laser light emanating from the remote end of the element transmitting the laser beam 340 will be reflected out of the opening or side door 114i. Accordingly, in this particular embodiment, the tissue penetrating element 120i is not formed of a solid material or penetrating apparatus of the deployable tissue, but instead comprises a pulsating or continuous laser light beam, capable of vaporizing or subjecting ablating the blood vessel wall and other extravascular tissue to form the desired extravascular passageway of the present invention. It will be appreciated that this embodiment of the penetrating element 102i of the fabric can be modified in various ways. For example, instead of the reflective surface 341 a continuous energy guide (eg, fiber optic) can extend through the catheter body and terminate at an exit door or lens located on the lateral wall of the catheter, such so that the flow of energy (for example, laser light) will flow outward in the lateral direction from the catheter. Alternatively, an energy-emitting apparatus may be mounted on or within the side wall of the catheter to emit the desired energy flow in a laterally outward direction from the catheter. In addition, the mode shown specifically in Figure 7i and the variations thereof mentioned above, will not be limited to laser energy, but may use any suitable flow of energy including heat, ultrasound, laser light, etc. Figure 7j shows yet another embodiment of tissue penetrating element 102j which can be incorporated into the catheters 100 forming the passageway of the present invention. In this embodiment, the tissue penetrating element 102j comprises an element that transmits the elongated laser beam, through which the laser energy can be passed in such a way that the laser energy will emanate out of the remote end 343 of the ray transmitting element. 102j laser elongated. The element that transmits the elongated laser beam 102j can be pre-bent in such a way that if it passes outside the opening 114 of the far end in a catheter 100, it will automatically bend or flex in a lateral direction to contact the wall of the catheter 100. blood vessel BV within which the catheter 100 is located, to allow the laser energy emanating from the remote end 343 of the element that transmits the laser beam 102j forms the extravascular passage 10 in the wall of the blood vessel and other extravascular tissue. Alternatively, it will be appreciated that several other output schemes may be used for the element that transmits the laser beam 102j, such as the openings in the side wall formed in the catheter 100, in accordance with the appropriate output schemes for all the elements 102. tissue penetrants as illustrated in Figures 6a-6i and fully described hereinbefore.
Figure 7k shows still another alternative embodiment of a tissue penetrating element 102k, usable in catheters 100 forming a passage, of the present invention. The penetrating element 102k of the fabric shown in Figure 7k comprises an elongated hollow needle having a lumen 316 extending longitudinally therethrough and having a sharp, tapered tip. A vacuum source (eg, a suction) 344 is attached to the proximal end of the lumen 316 of the tissue penetrating element 102k to pull or pull the tissue toward the lumen 316 when the far end of the tissue penetrating element is being advanced through the wall of blood vessel BV or other tissue through which the extravascular passage 10 of the present invention is to be formed. An optional seal fist 317, which comprises an inflatable annular balloon mounted around the exterior of the tissue penetrating element 102k at a spaced distance from the sharpened remote tip thereof, may be placed in abutting contact with the wall of blood vessel BV to form a seal which will prevent with the suction applied to lumen 316 that the blood be drawn or leaked out of the lumen of blood vessel BV. In this manner, the optional seal fist 317 may facilitate removal or aspiration of tissue from the vessel wall BV or other extravascular tissue towards the far end of the lumen 316 when the penetrating tissue element 102k is advanced through the tissue of the blood vessel wall or other extravascular tissue. Yet another embodiment of a tissue penetrating element 1021 usable in the catheters forming the passageway 100 of the present invention is shown in Figure 71. With reference to Figure 71, there is provided a penetrating element 1021 of the tissue formed by the combination of a penetrating element 102 of the standard fabric such as a solid or hollow needle having a sharp, tapered tip, and a surrounding tubular sheath 346 having an elastic pre-bent remote portion 347 and a hollow lumen 349 extending longitudinally therethrough . The liner 346 having the penetrating element 102 of the tissue mounted therewith is advanced through the lumen 112 of the catheter 100. When the portion 347 of the liner 346 is advanced outside the opening 114 of the end remote from the catheter 100, the pre-folded perineum 347 of the liner will automatically bend or flex in a lateral direction, as indicated above. After this, the piercing element 102 of the pre-bent; will be advanced through the lumen 349 of the liner 346, and through the wall of the blood vessel BV or other extravascular tissue. to form the desired extravascular passageway 10 according to the present invention. Optionally, a vacuum source 345 may be connected to the proximal end of the lumen 349 of the liner to draw or stretch the vessel wall BV in contact with the remote end of the remote portion 347 of the liner 346, thereby facilitating the advancement and the efficient penetration of the penetrating element 102 of the tissue through the wall of the blood vessel or other tissue. Yet another embodiment of a tissue penetrating element 102m is shown in Figure 7m. With reference to Figure 7m, a catheter 100 having a side wall opening 114 therein and a hollow lumen 112 extending longitudinally therethrough, and terminating in the opening 114 of the side wall is provided. A penetrating element 102 of the tissue, such as a sharp needle or hollow needle, can be advanced through lumen 112 of catheter 100 and outside of lateral aberration 114. A vacuum source 350 (e.g. a < - suction), is attached to the proximal end of lumen 112 and suction is applied, to remove or stretch the wall to blood vessel BV downwardly and in contact with lateral opening 114, as shown in figure 7m. Such suction-induced contact of the blood vessel wall BV with the lateral opening 114 facilitates the efficient advancement and penetration of the tissue penetrating element 102 through the wall of the blood vessel BV, to create the desired extravascular catwalk 10, in accordance with the present invention. Also, this suction fixation helps maintain the tissue which is being penetrated, in an exposed state, whereby the penetration of such tissue is facilitated. iii. Cage Modifier Apparatus Figures 8a-8h and the detailed description thereof described hereinafter, show various types of apparatus which can be used to treat, enlarge, unload, dilate, coat, coat or otherwise modify the extravascular passageway 10 formed initially by the penetrating element of the fabric 102. It will be appreciated and understood that the images of Figures 8a-8h and the following detailed description can be objected because they describe and illustrate representative examples of the passage modifying apparatus which can be used in accordance with the present invention, and are not intended to list and exhaustively describe each and every possible type of the catwalk modifying apparatus usable in accordance with the present invention.
Figure 8a shows a first embodiment of a passage modifier apparatus 500a comprising an elongated tubular member having a sharp, annular, sharpened cutting tip 502 formed on the far end thereof, and a hollow lumen 504a extending longitudinally to through it. This embodiment of the passage modifier apparatus 500a can be advanced on a guidewire GW which has been passed through the initial passage or tract created by the penetrating element 102 of the tissue, such that the remote cutting tip 502, nulling, unloading or enlarging the initial tract or passage formed by the penetrating element 102 of the tissue, to provide an extravascular passage 10 of the desired size and configuration. It will be appreciated that, the suction or vacuum may be applied to the proximal end of lumen 504a of this embodiment of the catwalk modifier apparatus 500a, to facilitate the formation of the tissue core by the remote cutting tip 502 such that the tissue being cut by the cutting, annular, cutting tip 502 will be withdrawn in the proximal direction through lumen 504a, and may be collected in a collection container appropriate for subsequent pathological examination. Figure 8b shows another embodiment of a catwalk modifier apparatus 500b which comprises a tapered dilator having a proximal portion 506 generally cylindrical, and a remote portion 508 tapered tapering. A hollow lumen 504b extends longitudinally through this embodiment of the passage modifier apparatus 500b in such a way that the passage modifying apparatus 500b can be advanced over a GW guidewire which has been inserted through the initial passageway or tract. created by the tissue penetrating element 102. When this modifying apparatus of the passageway 500b is advanced through such tract or passageway initially formed, the tapered remote portion 508 will expand the passage or tract to the enlarged diameter of the proximal portion 506 of the apparatus 500b. An optional power-emitting band 510 can be mounted around the proximal portion 506 of the apparatus 500b, so as to emit heat or other energy to further modify the surface of the passageway 10 when the apparatus 500b is advanced therethrough. Figure 8c shows a third embodiment of a passage modifier apparatus 500c which comprises an elongated tubular member having a sharp, annular, sharp cutting tip 512, which is similar to the remote cutting tip 502 of the embodiment shown here above in Figure 8a, but which is further adapted to emit the energy (e.g., heat, vibration, laser light, etc.).
In this embodiment of the apparatus 500c, an element or wire for the transmission of energy 514 extends through the tubular proximal portion of the apparatus 500c and is connected to the remote, annular cutting tip 512 to transmit the electric energy, the vibration ultrasonic, or any other suitable form of energy to the remote tip 512, to facilitate advancement of the remote tip 512 to the wall of the desired blood vessel or to another extravascular tissue. The hollow lumen 504 formed through the apparatus 500c allows the apparatus 500c to be advanced over a guidewire which has been placed within the initially formed passageway or tract created by the penetrating element of the tissue. The electric current or other energy will be passed through the transmitting element or wire of the energy 514 during the advance of the apparatus 500c, in such a way that heat or other energy is emitted by the remote tip to facilitate the passage and advance of the apparatus 500c through the tissue. It will be appreciated that a vacuum source (eg, suction) can be attached to the proximal end of lumen 504c to further facilitate advancement of the apparatus 500c through the tissue, and to remove any tissue with the core removed through lumen 504c of So that the removed tissue can be collected in the collection container and subjected to subsequent pathological study.
Figure 8d shows a fourth embodiment of a passageway modification apparatus 500d, comprising an elongated tubular catheter 516 having a hollow lumen 504d extending longitudinally therethrough and an annular balloon 518 mounted on the outer surface thereof. . A separate balloon inflation lumen (not shown) will extend through a proximal portion of the catheter 516 to allow the inflation fluid to be injected or withdrawn from the interior of the balloon 518. This embodiment of the catwalk modifier apparatus 500d can be advancing on a guidewire GW which has been placed within the initial passageway or tract created by the penetrating element of the tissue, until the deflated balloon 518 is placed within such initially created passageway or tract. After this), the balloon 518 can be inflated to dilate or stretch the initially formed passageway or tract, to procreate a modified extravascular passageway 10 having the desired diameter and / or configuration. Figure e reveals a fifth embodiment of a catwalk modifier apparatus .TR, which comprises an elongated, extendable catheter body, composed of a proximal portion 52C and a remote portion 520", placed in longitudinal alignment with each other. The proximal and the remote portions 520 'and 520' 'are connected to each other by two (2) cutting wires 522, which can be bent, elongated. A hollow lumen 504a extends through the proximal portions 520 'and remote 520' of the apparatus 500e, so that the apparatus 500e can be advanced over a guidewire GW which has been inserted through the passage or tract Initially created by the tissue penetrating element 102. A pull wire (not shown), or the guidewire itself, can couple the remote portion 520"of the catheter body so that the remote portion of the body of the catheter The catheter can be pulled in the approaching direction, whereby the gap between the proximal portion 520 'and the remote portion 520"of the catheter body is decreased. This will cause the cutting wires 522 to be warped outward, as shown by the interrupted lines on Figure 8e. In the operation, the aparate. 5C0e will be advanced on the GW guide wire and through the passage or tract formed initially. After this, the proximal portion 520"of the catheter body will be stretched in the proximal direction to match the distance between the far end of the proximal portion 520 'and the remote portion 520" of the catheter body, whereby the causes the cutting wires 522 to curve outwards. Optionally, the electric current can be passed through the cutting wires in such a way that the cutting action of the wires will be improved. After this, the apparatus 500e will be stretched in the proximal direction through the passageway or tract formed initially, created by the penetrating element 102 of the fabric, such that the cutting wires 522 curved outward will enlarge the passage or tract formed initially to converting by this the passage or tract into an extravascular passageway 10 resembling an enlarged slot, in accordance with the present invention. Fig. 8f shows a sixth embodiment of a passage modifier apparatus 500f, which comprises an elongated shaft member 530 having a cutting or withdrawing cutting apparatus 532, mounted on the remote end thereof. The withdrawal cutting apparatus 532 comprises a rigid element having a dull remote surface 534 and a proximal cutting edge 536 annular. A hollow lumen 504f extends longitudinally through the axis 530 and the withdrawal cutting element 532 in such a way that the apparatus 500f can be advanced on a guidewire GW which has been inserted into the passage or tract formed initially, created by the penetrating element 102 of the fabric. After the withdrawal cutting element 532 has been completely advanced towards the passage or tract formed initially, it will be retracted in the approaching direction in such a way that the proximal cutting surface 536 will separate the fabric by cutting, so as to enlarge or unload the passageway. Optionally, the cutting surface 536 can be rotated during retraction of the removal element 532 to facilitate cutting of the fabric. Also, optionally, an anvil (not shown) may be placed at the opposite end of the passageway 10 to provide a back pressure against the cutting edge 536, whereby cutting of the fabric by the withdrawal cutting element 532 is facilitated. is cut from the part of the passageway by the proximal cutting surface 536, it will be collected inside the inner chamber 538 of the withdrawal cutting element 532. Figure 8g shows a seventh embodiment of a modifying apparatus 500g of the passageway, which comprises an elongated shaft 540 having a forward pushing cutting element 542 mounted on the distal end thereof. A hollow lumen 504g extends longitudinally through the axis 540 and the cutting element 542 in such a way that the apparatus 500g can be advanced on a guidewire GW which has been inserted through the passage or tract formed initially, created by the penetrating element 102 of the tissue. The cutting element 542 comprises a remote portion 542 'having a generally cylindrical external surface and a proximal portion 542' 'having an outwardly tapered outer surface. A sharp annular cutting edge 544 is formed on the far end of the remote portion 542 'such that, when the apparatus 500g is advanced in the direction away, the cutting edge 544 will cut a generally cylindrical mass of the tissue, to enlarge by means of this the passage or tract formed initially, through which the apparatus 500g is advanced. Optionally, the sharp annular cutting edge 544 of the apparatus 500g can be rotated during the advancement of the apparatus 500g. Also, an optional anvil (not shown) can be placed at the opposite end of the passageway 10 to provide a back pressure against the cutting edge 544, whereby cutting of the fabric by the apparatus 500g is facilitated. Figure 8h shows an eighth embodiment of a modifying apparatus 500n of the passageway. Such an apparatus comprises an elongated tubular member 550 having a lumen 504h extending longitudinally therethrough. A plurality of external flow openings 554 are formed in the tubular element 550, within a region which is at a distance spaced from the far end of the tubular element 550. Also, an outlet opening of the remote guide wire is formed in the end remote from the element 550 in such a way that the apparatus 500h can be advanced on a guidewire GW which has been inserted through a passage or tract formed initially, created by the penetrating element 502 of the fabric. The proximal and remote sealing balloons 552 ', 552"are formed around the outer surface of the tubular member 550, proximal and remote with respect to the external flow openings 554. As shown in Figure 8h '', the tubular element 550 can be advanced over the guide wire GW until the external flow openings 534 are located within the passageway 10 which is to be treated with a liquid substance that can flow . After this, the annular seal balloons 552 ', 552"will be inflated to completely seal the opposite ends of the passageway 10. After this, the desirable, flowable substance will be passed through the lumen 504h of the tubular member. 550 in such a way that it will flow outwardly from the external flow openings 554 and fill the interior of the passageway 10, which remains sealed by the sealing balloons 552 ', 552". After the material that can flow has effected the desired treatment of the walls of the passage 10, the negative pressure can be applied to the lumen 504h to remove or extract the material that can flow from the interior of the passageway 10. After this, the sealing balloons 522 ', 522"will be deflated and the apparatus 500h will be removed and removed from the catwalk 10. Figure 8h 'shows an alternative modification of the device 500h' in which none of the openings 554 for the external flow of the liquid are formed on the tubular element 550, but instead, an energy transmitting element ( not shown) such as a wire, will extend through the body of the tubular element 550 and the region of the tubular element 550 between the sealing balloons 552 ', 552"will be equipped with an electrode, electrocautery device, resistance heater, laser beam device, or other energy-emitting apparatus, such that the outer surface of the tubular member 550 between the sealing balloons 552 ', 552"will become heated or will otherwise use energy to treat the walls of the passage 10 when the appliance 500h '' becomes placed in the passageway, in the manner described hereinabove with reference to Figures 8h and 8h ''. iv. Apparatus for Longitudinal Compression and / or the support of the Extravascular Passages formed between two Blood Vessels In those applications where the extravascular passages 10 to the present invention are formed between two [2, blood vessels (as in many of the revascularization procedures described above) the presence of cavernous or loose tissue between the walls of the blood vessels may be problematic, because the blood flowing through the passage 10 may tend to infiltrate such cavernous or loose tissues, thereby causing the blood to leak and / or the formation of bruises. Other means to prevent such infiltration of blood into the tissue or space between the walls of the adjacent blood vessels, is the placement of a compression apparatus 22 of the longitudinal passageway, within the passageway 10 to compress such cavernous or loose tissue, so which prevents the infiltration of blood in it. In addition, the deployment of the longitudinal compression pad 22 within the passageway 10 may additionally provide the structural support within the passage to maintain the passageway opening and prevent undesirably bending or closing of the passage due to movement of the adjacent tissues. It will be appreciated, however, that any longitudinal compression apparatus 22 will preferably be constructed to provide sufficient longitudinal compression to prevent unwanted infiltration of blood into adjacent tissues but will not cause overcompression of such tissues which could cause iatrogenic ischemia and the possible necrosis of such tissues. Figures 9a-9f '' 'and the following detailed description of such figures are directed to examples of the specific longitudinal compression apparatus 22 which can be placed within the extravascular passages 10 of the present invention to prevent infiltration into the tissue of the blood and / or to provide structural support within the passageway. It is to be understood that Figures 9a-9f '' 'and the following detailed description are not intended to list and exhaustively describe all possible types of the longitudinal compression apparatus 22 which may be usable in accordance with the present invention. Instead, these figures and the following detailed description are only examples of the types of longitudinal compression apparatus 22, which can therefore be used. The utility of the longitudinal compression apparatus 22 shown in Figures 9a-9f '' 'and described hereinafter, is not necessarily limited to the extravascular catwalks 10 of the present invention, but may also be usable in relation to other methods for forming the collateral connections (for example, anastamosis) between the juxtaposed tubular anatomical passages of the body such as blood vessels, uterine tubes, etc.
Figures 9a-9a 'show a first embodiment of a longitudinal compression apparatus 22a which comprises a first annular element 600 and a second annular element 602, which are directly alignable and connectable with each other so as to longitudinally compress the walls of the blood vessels and other tissues which surround the passage 10 formed between two blood vessels BVX and BV2. The first circular element 600 has a plurality of leg elements 604 which extend from one side thereof. The second circular or ring element 602 has a plurality of receiving openings 606 which are positioned and configured to receive the leg members 604 therein. Each of the elements of the legs 604 has a bayonet connector 608 or another type of connector formed thereon such that, when the elements of the legs 604 become inserted in the receiving openings 606, the connector 608 will engage the corresponding elements or surfaces formed within the receiving openings 606 so as to fix and retain the first and second ring elements 600, 602 in a manner which causes longitudinal compression of the portions of the walls of the blood vessels BVi and BV2 and other intervening tissues, which surround the passage 10.
Figures 9b-9b '' 'show a second embodiment of a longitudinal compression apparatus 22b which comprises an elastic wire ring (e.g. superelastic) which has been bent in the configuration shown in Figure 9b having two segments upper arches 610 ', 610' 'and two lower arched segments 612' and 612 '', as shown. The apparatus 22b is initially mounted within the lumen 614 of a tubular catheter 616. An internal catheter element 618 having a remote portion of reduced diameter, is coaxially positioned within the lumen 614 of the external catheter 616, such that the arcuate portions 612 ', 612' 'longitudinally extended, of the apparatus 22b, are captured and frictionally coupled between the external surface of the reduced diameter portion remote from the inner tubular catheter 618, and the internal luminal surface of the external catheter 616, as shows in figure 9b '. The external catheter 616 is initially advanced through the passageway 10 where the device 22b is to be deployed, and the inner catheter 616 is then advanced in the away direction to push the upper arched portions 610 ', 610"extended longitudinally, outside the end opening away from the catheter 616, such that the upper arcuate portions 610 ', 610"will be flexed elastically outward to become placed on the lumenal surface of the first blood vessel BVi. After this, the internal catheter 618 is withdrawn or stretched back to release the lower arched portions 612, 612 ', 612"longitudinally extended, which form a frictional engagement and which are captured between the internal tubular catheter 618 and the tubular catheter 616, and the outer tubular catheter 616 is withdrawn such that the lower arcuate portions 612 ', 612"will pass out the open end of the catheter 616 and will flex outwardly to abut against and to engage the luminal surface of the second blood vessel BV2, whereby the walls of blood vessels BVi and BV2 and the cavernous or loose tissue placed between them are compressed, in the manner illustrated in Figure 9b. The circular wire element from which the apparatus 22b is formed, may be any suie elastic material type, and may preferably comprise a nickel-titanium alloy or polymer exhibiting superelasticity or high flexural properties within the temperature range which will be found by the apparatus 22b during deployment and implant within the body of the mammal.
Figure 9c shows a third embodiment of a longitudinal compression apparatus 22c comprising a first toroidal balloon 620 and a second toroidal balloon 622. The first and second toroidal balloons 620, 622 are placed in longitudinal alignment with each other and are joined by a plurality of longitudinal connector elements 624. The apparatus 22c is initially positioned within the passageway such that the first toroidal balloon 620 is positioned adjacent to the luminal surface of the first blood vessel BV¿ and the second balloon twisted! 622 deflated is positioned adjacent the luminal surface of the second blood vessel 622, with connecting elements 624 extending longitudinally through the passageway 10. After this, the first and second toroidal balloons 620, 622 are inflated to compress the portions longitudinally. of the walls of blood vessels BVX and BV2 and the portions of the tissue located between them, which surround the loop 10, as shown in Figure 9c. The toroidal calix element 620, 622 can be inflated with a curable or gelatinous polymer substance which will be partially or fully sealed after the toroidal balloon element 620, 622 has become inflated, thereby avoiding any problem with the downstream leak or deflation to the toroidal balloon element 620, 622.
Figure 9d shows a fourth embodiment of a longitudinal compression apparatus 22d which comprises a first annular magnet 626 and a second annular magnet 628 connected by a plurality of longitudinal connector elements 630. The apparatus 22d is initially deployed within the passageway 10 of such so that the first annular magnet 626 is positioned adjacent the luminal surface of the first blood vessel BVi and the second annular magnet 628 is positioned adjacent the luminal surface of the second blood vessel BV2. These annular magnets 626, 628 are then allowed to move magnetically towards each other in such a way that the longitudinal connecting elements 630 will become coupled and will longitudinally connect the magnets, whereby the adjacent portions of the walls of the vessels are compressed. blood BV. , BV. and any fabric placed therebetween, which surrounds the passageway 10. Figure 9e shows a fifth embodiment of a longitudinal compression apparatus 22e comprising a first ring element 632 and a second ring element 634, which can be compressed inwards and connected by the inflation of the first and second balloons 640, 642. At least one connector element 636 extends from the inner side of the first ring element 632. At least one corresponding receiving aperture (not shown) is / are formed in the second ring element 634, and such receiving opening (s) is / are dimensioned and configured to receive the connector element (s) 636, and to engage teeth of saw or other engageable surfaces formed on the connector element (s) 636. The apparatus 22e is mounted within the passageway 10 initially advancing the catheter 638, with the balloons 640, 642, deflated, through of the passageway until the upper ring element 632 is juxtaposed with and in abutting contact with the lumenal surface of the first blood vessel BVi, and the second ring element 634 is juxtaposed with and in abutting contact with the luminal surface of the blood vessel. second blood vessel BV2. After this, the balloons 640, 642 are simultaneously inflated to push the ring elements 632, 634 inwardly with each other. When the ring elements 632, 634 are pushed inward, the legs 636 of the first ring element 632 will be advanced further towards the receiving openings of the second ring element 634 and the saw teeth on the leg 636 will be coupled in a manner friction and maintained within such receiving apertures (not shown). When the desired amount of compression of the walls of the blood vessels BVi, BV2, and the tissue interposed therebetween and surrounding the passageway 10 has been achieved, the balloons 640, 642 can be deflated, and the catheter 638 carrying the deflated balloons 640, 642 will be removed or removed, leaving device 22e in place within passageway 10. Figures 9f-9f "'' 'show a sixth embodiment of a longitudinal compression apparatus 22f which may be mounted within the passageway. extravascular 10 formed between two blood vessels BVi, BV2, according to the present invention. As shown, this apparatus 22f comprises a plurality of elastic, pre-bent, elongated, substantially parallel wire elements 646 arranged or arranged in a generally cylindrical array. Optionally, a cylindrical connector element 648 formed of rigid or foldable material may be connected to each of the individual wire elements 646 to retain them in the desired cylindrical arrangement. Each wire element 646 is pre-bent so that, when it is not under pressure, the opposite ends of each wire element 646 will bend outwardly so as to cause the wire element to assume a generally "shaped" configuration. C ", as it is shown by the dotted lines in Figure 9f ''. Initially the apparatus 22f is mounted within the lumen 652 of a tubular delivery catheter 650. An internal tubular catheter element 654 is positioned coaxially within lumen 652 of delivery catheter 650. Internal catheter 654 has a remote portion 656 of reduced external diameter. The apparatus 22f is mounted within the lumen 652 of the delivery catheter 656 such that the individual wire elements 646 are restricted and maintained in substantially straight configurations. The proximal ends of the wire elements 646 are captured between the outer surface of the remote portion 656 of the internal tubular catheter 654 and the internal luminal wall of the external catheter 650 as shown in Figure 9f '. The apparatus 22f is implanted within the passageway 10 by initially passing the delivery catheter 650 into the passageway 10 such that the distal end of the delivery catheter is flush with the lumenal surface of the first blood vessel BVL as shown in Figure 9f ' After that, the inner tubular catheter 654 is advanced in the away direction to cause the remote ends of the wire elements 646 to come out of the far end of the outer catheter 650, whereby the far end of the wire element 646 is allowed it curves outwards and makes butt contact or becomes compressively inserted within the lumenal surface of the first blood vessel BV .., as shown in Figure 9f '' '. After this, the inner catheter 654 is retracted slightly in the approaching direction to free the proximal lens from the wire elements 646 of the catch and friction engagement between the remote portion 656 of the inner tube 654 and the inner luminal surface of the outer tube. 650. After this, the entire catheter 650 is retracted in the proximal direction whereby the entire apparatus 22f is released from the restriction of the surrounding catheter 650 and the proximal ends of the wire elements 646 are allowed to bend and join. or they become compressively inserted into the luminal surface of the second blood vessel BV2, as shown in Figure 9f '' '. In this way, the apparatus 22f serves to compress the walls of the blood vessels BVi, BV2, and any tissue interposed therebetween, in the area surrounding the passageway 10. Additionally, as shown in Figure 9f '' ' , it will be appreciated that in embodiments where the cylindrical connector element 64b is employed, such a cylindrical connector element may comprise a segment of bioprosthetic graft material to form a substantially tubular internal coating within the passageway 10, as illustrated in Figure 9f ' '' '. It will be appreciated that, although the apparatus 22f has hereinabove been described as a pre-bent elastic structure, the wire elements 646 may alternatively be formed of a malleable metal or other pressure-deformable material and a suitable deformation tool such as an inflatable balloon. it can be deployed within the introducer catheter 650 to voluntarily pressurize the ends of the wire elements 646 as they pass out of the catheter tube 650, whereby the desired pre-bent "C" shaped configuration is provided. v. A System and Catheter that Forms a Catwalk Favorite The Figures 10A-llo show two basic embodiments of a catheter forming a preferred passage, and an accompanying apparatus which is combined to form a system forming the passageway, according to the present invention. Figures 12a-13 __ * provide step-by-step views of the preferred method, to use the system and catheters that form the passageway, shown in Figures 10A-11, to create an extravascular passageway 10 between two blood vessels PV_, BV. adjacent. with reference to FIG. 10A-10c, there is shown a first modality and a lOOp catheter device forming the preferred passageway, which comprises a flexible elongated catheter body 700 having a lumen 702 extending longitudinally through and ending, at its far end, in a remote outlet opening 704. A penetrating element 102 of the fabric, which may comprise any penetrating element of the fabric including any of those shown in Figures 7a-7k and described hereinabove, is placed within the lumen 702 of the body 700 of the catheter. It will be appreciated that the exit aperture 704 and lumen configuration 702 can be modified to accommodate any of the appropriate exit schemes for passing the tissue penetrating element out of the exit aperture 704, including those exit schemes of the elements. penetrating, shown specifically er. Figures 6a-6i, and described hereinabove. The body 700 of the flexible catheter is preferably formed of a flexible polymeric material such as nylon, pebax, pclietilenc, etc., or a collapsible metal pipe such as a thin-walled hypotube. An eta tape, ica or other reinforcing material may be mounted on and formed within the wall of the catheter body 700 to provide structural reinforcement and for perr.it .. r that the body of the catheter 700 be rotated or applied to it. a twisting torque without curling or undue distortion. Additionally, in embodiments wherein the tissue penetrating element 102 comprises a pre-bent needle or elastic element, a rigid tubular reinforcement element 701 may be placed around a portion remote from the lumen 702 of the catheter body 700, as shown in FIG. Figure 10b, to provide a rigid restriction for the pre-bent remote portion of the penetrating element 102 when the penetrating element 102 is retracted towards the lumen 702 of the catheter body 700. The presence of such a tubular reinforcing element 701 will further prevent any sharp pointed tip on the tissue penetrating member 102 from making a mark or penetrating the relatively soft plastic material from which the body 700 of the catheter can be made. A hand piece 706 is mounted on the proximal end of the body 700 of the collapsible catheter. The handmade piece 706 comprises a rigid outer shell having a hollow internal cavity 712, generally cylindrical, formed therein. A proximal portion of the tissue penetrating element 102 extends into the internal cavity 712 of the hand piece 706. An actuator button 710 is connected to the tissue penetrating element 102, as shown in Figure 10c. The actuator button 710 may be depressed and advanced in the remote direction to cause the tissue penetrating element 102 to pass out of the exit aperture 704 for the purpose of forming an extravascular passageway 10 of the present invention. After this, the actuator button 710 can be retracted in the approaching direction to retract the tissue penetrating element towards the lumen 702 of the body 700 of the flexible catheter. Optionally, a lateral slide 720 of the catheter for imaging can be attached to the remote portion of the body 700 of the flexible catheter. This lateral slide 720 of the catheter for imaging comprises an elongated tube having a lumen 722 extending longitudinally therethrough. A window 724 is formed in the upper side wall of the lateral carriage 720, immediately adjacent the exit opening 704. An imaging catheter 50, such as an intravascular ultrasound catheter of the commercially available types of Boston Scientific / Cardiovascular Imaging, MA; Endosonics, Inc., Pleasonton, CA: and Hewlett-Packard, North Andover, MA. , it is insertable into the lumen 722 of the sidecar 720 in such a way that the sensor portion 52 (for example, the portion where the ultrasound for image formation is emitted and received) is placed after the window 724. material from which the sidecar 720 is made, is preferably a material which will prevent the transmission of the type of energy (e.g., ultrasound) which is used by the imaging catheter 50, but the window 724 is either in an open entrance or. it is covered with a material which can be permeated by the energy used by the catheter for imaging 50. In this way, the sensing portion 52 of the imaging catheter 50 will receive an image only of the area which is in alignment with the window 724. Additionally, the window 724 is preferably of a rectangular configuration and is confined to the lateral wall of the lateral carriage 720 which is immediately adjacent to the outlet opening 704 of the body 700 of the flexible catheter. In this way, such sizing, configuration and specific placement of the window 724 may allow the user to perform the precise rotational orientation of the lOOp catheter apparatus by simply rotating the lOOp apparatus until the target or target tissue (e.g., another blood vessel) ) is clearly seen by the imaging catheter 50 through the window 724, whereby it is indicated that the exit opening 704 is correctly positioned so that the subsequent passage of the penetrating element of the tissue 102 out of the opening The outlet 704 will cause the penetrating element 102 of the tissue to advance through the wall of the blood vessel in which the lOOp catheter apparatus is located, and toward the target or target tissue (e.g., another blood vessel). In addition, such placement of the window 724 will allow the catheter for the formation of the images 50 to be used to observe the actual movement and penetration of the penetrating element 102 of the tissue, whereby it is ensured that the extravascular passageway is formed at the location desired. As an alternative for the formation of a window 724 at a discrete location within the sidecar 720, the far end of the sidecar 720 may be located adjacent to the site at which the tissue penetrating member 102 passes out of the body 700 of the catheter and the sensing portion 52 of the catheter for forming the images 50 can simply extend out of and beyond the far end of the side carriage 720 in such a way that it can clearly form the image of the deployment and movement of the penetrating element 102 of the tissue. In this alternative arrangement the field from which the image was formed by the catheter 50 for the formation of the image, will no longer be limited or inhibited by the window 724 and the catheter for the formation of the images 50 may be able to form an image. in a total radius of 360 ° around the far end of the side carriage 720. Accordingly, any suitable types of the marking apparatus or marking materials can be formed on the lOOp catheter apparatus or tissue penetrating element 102p to allow the catheter 550 for the formation of the images to be used for the desired function of determining the correct rotational orientation of the lOOp catheter device prior to the deployment or actuation of the penetrating element 102 of the tissue. Additionally, as described hereinabove, a lumen 726 of the guidewire may extend longitudinally through tissue penetrating element 102 and may terminate away from an outlet opening 728 of the guidewire formed at the remote end of the penetrating element 102 of the guidewire. tissue. In this way, a guide wire GW can extend through the penetrating element 102 of the fabric and can be advanced out of the outlet opening 728 of the guide wire. In embodiments wherein the penetrating element 102 of the tissue is provided with a lumen 726 of guide wire and the outlet opening 728 of the guide wire at its remote end, the presence of a GW guidewire within such a lumen 726 can be used as a means to determine exactly when the end remote from the tissue penetrating element 102 has penetrated into the lumen of a target or target blood vessel or other cavity or area open To accomplish this, the directed pressure to distar, continuous, or intermittent, will be applied to the guidewire GW when the penetrating element 102 of the tissue is advanced through the wall of the blood vessel in which the lOOp catheter apparatus is located and through any other extravascular tissue through which the passageway 10 will pass. As the far end of the tissue penetrating element 102 is in abutting contact with the tissue, the GW guidewire will be prevented from coming out and moving out of the way. the outlet opening 728 of the guide wire of the far end and, consequently, the distance directed pressure applied to the guide wire GW will be of satisfactory strength due to the presence of the tissue which butts against the exit opening 728 of the guide wire . However, when the far end of the tissue penetrating element 102 is inserted into the target or target blood vessel lumen or other open space, the exit opening 728 of the guidewire will be immediately discovered and the guide wire GW will be allowed which rapidly advances out of the outlet opening 728 of the guidewire, in response to the remote directed pressure that is applied thereto. Such rapid advancement of the guide wire GW will send a signal to the operator that the tip away from the penetrating element 102 of the tissue has actually been introduced into the lumen of the target or other target blood vessel or other open space. At this point, the advance of the penetrating element 102 of the tissue can be stopped at will, so as to avoid any possibility that the penetrating element of the tissue will perforate the contralateral wall of the target or other blood vessel on the other side. of the open area within which the passageway 10 will extend. Figures 10c '-10c' '' provide a schematic illustration of an apparatus which can be incorporated into the lOOp catheter forming the passageway, to exert a directed distance, intermittent or continuous pressure, on the guidewire GW, as shown in FIG. described here above, to determine when the far end of the tissue penetrating element 102 has been passed to the lumen of the target or cDjetivc blood vessel or other open space. With reference to FIGS. 10c '' ', the apparatus 800 comprises one or more springs 802 which are connected, by means of a connector element 804, to a portion of the wire, which extends from the proximal end of the body 700 of the catheter. It will be appreciated that the apparatus 80C may be incorporated within the internal cavity 712 of the hand-made piece 706, or it may be formed as a separate unit which is mountable on the proximal end of the hand-made piece 706.
As shown in Figure 10c, prior to the beginning of the procedure, the guidewire GW can freely extend out of the outlet opening 728 at the far end of the penetrating element 102 of the fabric, whereby the spring elements 802 are allowed. of the 800 device assume a relaxed configuration (for example, shortened). Figure 10c '' shows that, when the tissue penetrating element 102 is advanced through the tissue, the remote end of the guidewire GW will be maintained level with the outlet opening 728, and the elastic elements 802 of the apparatus 800 will arrive to be subjected to tension (eg, stretched) due to the dnce directed pressure that is applied by the remote tip of the guidewire GW against the adjacent tissue. Figure 10c '' 'shows that, when the tip away from the penetrating element 102 of the tissue has exited towards the lumen of a blood vessel or other open area, the guidewire GW will be immediately advanced out of the exit aperture 728 of the wire guide, whereby the spring elements 802 of the apparatus 800 are allowed to assume once more their relaxed (eg shortened) configuration. This abrupt advance of the guidewire and the relaxation of the spring elements 802 will send signals to the operator, that the penetrating element of the tissue 102 has arrived inside the lumen of the blood vessel or other open space, and that the further advance of the element 102 Penetrating tissue must be stopped. As stated hereinbefore, it will be appreciated and understood that the apparatus exerting the pressure, described and shown in Figures 10c '-10c' '' is optional and does not necessarily need to be included within the lOOp catheter device. In addition, it will be understood and appreciated that the continuous or intermittent thrust of the guidewire GW in the remote direction can be carried out manually (ie by hand) without the need to use any device. The figures show the manner in which the lOOp system and catheter which forms the preferred passageway can be modified to accommodate the specific type of tissue penetrating element 102f in FIG. 7f and described hereinbefore. This penetrating element of the particular tissue is composed of an internal puncturing element 322 and an outer lining 326 that is longitudinally advanced. Figures 11-lld show a preferred, modified, 100p 'catheter device, which, similar to the previously described embodiment of the lOOp catheter device, comprises a flexible catheter body 700 having a lumen 702 extending longitudinally to the catheter. through it, a hand-made piece 706 having an internal cavity 712 formed therewith, and a sidecar 720 of the catheter for imaging, having a lumen 722 and the window 724 formed therein, the entire of which are described in detail here above. In this embodiment of the lOOp 'catheter device, the hand piece 706 is modified to incorporate first and second actuator buttons 710a, 710b. The first actuator button 710a is connected to the pre-bent elastic inner member 322, which has a sharp trocar tip 324 on the remote end thereof. The second actuator button 710b is connected to the tapered foldable liner 326 which can be advanced longitudinally on the internal member 322, in the manner described in detail here above with reference to FIG. 7f. Accordingly, in this modified embodiment of the catheter device 100p ', the inner member 322 and the surrounding liner 326 can be advanced and retracted independently using the actuator button 710a, 710b. It will be appreciated that, when the inner member 326 is free of any lumen of the guidewire, it will be optional to apply a dnce directed, continuous or intermittent pressure, to the outer skin 326 to perform the same function of signaling the penetration of the lumen described hereinbefore. with reference to figures 10c '-10c' ''. In consecuense, the spring apparatus 800 for applying a constant or intermittent pressure can be attached to the liner 326 in this embodiment of the catheter device 100rpm to continuously push the blade 326 in the away direction, in the same manner as described in the wire GW guide in figures 10c '-10c' '', or it can be carried out (if desired) by a manual technique. The catheter devices 100 and other devices and apparatuses described herein can be combined in various ways to form unique systems for carrying out the methods of the present invention. The systems described herein should be understood as going to be combinations of one or more of the described functional components, described. The components of these systems can be used in a mechanical or temporal relationship with each other to carry out the novel methods described herein, and can be used in any of the numerous possible combinations that sufficiently accomplish the stated objectives. Such systems may include a catheter body sized to fit within a blood vessel and may be advanced to a location which is in proximity with an extravascular target or target or vascular target of the environment. The catheter may be further combined in some manner with one or more of the passive or active orientation means, described, to aid in the proper placement of the catheter in the blood vessel with respect to the target or target. In addition, the catheter can incorporate at least one of the penetrating elements of the tissue in such a way that a passage can be formed from the blood vessel to the target or target. The system may also incorporate a guidewire sized to be inserted into the passageway, and inserted through the catheter in such a way that it can enter the passage and provide a rail to the target or target. The system may also incorporate the placement of one or more of the devices that are insertable or insertable into the passageway over the guidewire, such as means for maintaining and sizing the channel or other devices to effect a therapeutic or diagnostic endpoint. Also, the systems may include one or more of the various blood vessel blocking means such that a blood vessel in operative association with an extravascular catwalk of the present invention can be blocked or occluded to allow redirection of the blood. saw. Operation of the Preferred Modalities of the System and Catheter of Catwalk Formation Figures 12a-12d provide a step-by-step image of the preferred method of using the first embodiment of the lOOp tissue penetration catheter device shown in Figures 10-10c '. "Figures 13a-13b provide a step-by-step image. of the preferred method of utilization of the second embodiment of the system and catheter device forming the preferred passageway lOOp 'With reference to Figures 12a-12d, a catheter for image formation 50 is inserted into lumen 722 of the lateral cart 720 so that the sensing portion 52 for imaging the catheter 50 is positioned adjacent to the window 724. In this manner, the combi ise of the catheter for image formation 50 with the catheter member 100 '. which forms the passage, form a "system" according to the present invention with the penetrating element 102 of the tissue retracted towards the lumen 704 of the body 700 of the flexible catheter of such a Since the tip remote from the tissue penetrating element 102 is housed within the tubular reinforcing element 701, the system comprising the catheter apparatus -100p and the imaging catheter 50 is inserted into the vasculature of a mammalian patient and it advances until the far end of the catheter body 700 and the far end of the sidecar 720 are placed within a first blood vessel BVi located adjacent to a second blood vessel BV2 with the intention of forming a passageway 10 between the first blood vessel BVi and the second blood vessel BV2. The lOOp catheter device is then rotated until the IF imaging field observed by the catheter 50 for image formation, through the window 724, clearly detects the second blood vessel BV2 within which it is going to extending the passageway 10. This indicates that the lOOt catheter device has been placed in the correct rotary orientation to allow the penetrating member 102 of the tissue to form the passageway 10 in the desired location, such that it will extend into the second location. blood vessel BV2. After this, the actuator button 710 will be advanced until the tip away from the tissue penetrating member 1C2 begins to penetrate through the wall of the first blood vessel BVj. Optionally, the distance directed, intermittent or continuous pressure can to be applied to the guide wire GW manually (i.e. manually) or by the apparatus exerting the pressure 800, when the advancement of the tissue penetrating element 102 continues. With reference to FIG. 12b, as soon as the tip away from the tissue penetrating element 102 exits towards the lumen of the second blood vessel BV2, the GW guidewire will rapidly advance in the direction of travel, whereby a signal will be sent to the operator. that the advancement of the penetrating element 702 of the tissue must be stopped. At this point, the operator will stop further advancement of the actuator button 710. After this, the actuator button 710 will be retracted to its full proximal point to retract the penetrating element 102 from the tissue in the lumen 702 of the catheter body 700, while the guide wire GW is allowed to remain extended through the newly formed passageway 10 and towards the lumen of the second blood vessel BV2. As shown in Figure 12c, the lOOp catheter device that forms the catheter and the accompanying catheter 50 can then be removed and removed from the body, leaving the GW guidewire placed through the first blood vessel. BVi, through passage 10 and into the second blood vessel BV2. As shown in Figure 12d, an apparatus 500 modifier of the passage, such as any of the types of apparatuses 500 modifiers of passageways shown in figures 8a-8h, can then be advanced on the guide wire GB to modify (for example, enlarge, unload, coat, treat, etc.) the passage 10. It will be appreciated that, after the step shown in Figure 12v has been supplemented, the guidewire GW can be left in place through the passageway 10 to allow that any number of small tubes, grafts with small tubes, or apparatus 22 restricting the passageway, as shown in Figures 9a-9f, are deployed within the passageway 10. Figures 13a-13e illustrate a preferred method step by step for use the modified system mode and lOOp catheter device that forms the catwalk, shown in figures lla-llb. Initially, the desired imaging catheter 50 is inserted into the lumen 722 of the lateral carriage 720 such that the catheter for the formation of the images 50 and the catheter device 100p 'for the formation of the passageway will form, in combination, a "system" of formation of passages. The lOOp catheter for the catheter formation and the catheter 50 for accompanying image formation are then advanced towards the vasculature to a point where the far ends of the catheter body 700 and the side carriage 720 are placed inside the catheter. a first BVX blood vessel immediately adjacent to a second blood vessel BV2, between which a passageway 10 is to be formed. The imaging catheter 50 is then energized such that the sensor portion 52 of the catheter for the formation of the images will receive an image within the field of the IF image through window 724. The catheter device 100p 'is then rotated until the second blood vessel BV2 within which the catwalk 10 is to be extended its image is clearly formed by the catheter for imaging 50 through the window 724. This indicates that the orientation and correct rotational positioning of the device 100p 'catheter has been achieved. Additionally, the catheter device 100p 'can be moved longitudinally until the desired flow characteristics are observed within the second blood vessel BV2 in the field of the IF image, whereby it is indicated that the lOOp catheter device is in its position correct longitudinal. Additionally, the catheter for the formation of the images 50 can be used to determine the distance between the first blood vessel BVi and the second blood vessel BV2, to define the distance which the penetrating element 102f of the tissue must be deployed to form the catwalk desired from the first blood vessel BVX to the second blood vessel BV2. As shown in Figure 13a, after the lOOp 'catheter has been longitudinally and rotationally oriented, the tissue penetrating element 102f is deployed outside the catheter body 700, and begins to advance through the wall of the first blood vessel BVi. . The outer liner 326 of the tissue penetrating element 102f will be in a slightly retracted position such that the tip of the trocar 324 extends out of the far end of the liner 326 to effect the desired penetration through the tissue. During the advancement of the tissue penetrating element 102f as shown in Figure 13a, the manual pressure or the pressure exerted by the apparatus 800 can be used to apply a pressure directed remotely to the liner 326. In this way, when the trocar tip 324 of tissue penetrating element 102f is inserted into the lumen of the second blood vessel BV2, the liner 326 will be advanced immediately forward towards the lumen of the second blood vessel BV2, whereby a signal is sent to the operator that the desired passageway has been formed and that any further advancement of the penetrating element 102f of the tissue must be stopped.
Figure 13b shows that, after the lining 326 has advanced towards the lumen of the second blood vessel BV2, the elongated trocar tip element 322, can be removed and removed, whereby it is left to the liner or wrap 326 as a conduit through the passageway 10. As shown in Figure 13c, a GW guide wire can be then pass through the lumen of the liner 326 and into the second blood vessel BV2. After this, as shown in the figure 13d, the lOOp 'catheter device forming the catwalk and accompanying the catheter 50 for image formation can be removed and removed from the body, whereby the guidewire GW is left in place, and extended to through the lumen of the first blood vessel BVi, through the passageway 10 and into the second blood vessel BV2. After this, as shown in Figure 13e, any type of modified modifier of the passageway 500 can be advanced on the pre-positioned GW guide wire, to effect the desired modification of the passageway 10. It will be appreciated that the invention has been described here above only with reference to certain modalities and specific examples. No effort has been made to exhaustively describe all possible amendments of the invention, or to provide examples of each and every one of the ways in which the invention can be practiced. Actually, those skilled in the art will recognize that various additions, deletions, modifications and alterations can be made to the embodiments and examples described above without departing from the spirit and scope proposed of the invention. Accordingly, it is proposed that all additions, deletions, modifications and alterations be included within the scope of the following claims.
It is noted that in relation to this date the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Having described the invention as above, it is claimed as property and / or content in the following

Claims (125)

1. A method of revascularization, the method is characterized in that it comprises the step of: a) forming an extravascular passageway between a first location on a blood vessel and a second location on the blood vessel, such that blood having a p02 of minus 50 will flow through the extravascular catwalk.
2. The method according to claim 1, characterized in that the first location and the second location are on at least one blood vessel of the heart.
3. The method according to claim 1, characterized in that the first location and the second location are on the same blood vessel.
. The method according to claim 1, characterized in that the first location and the second location are on different blood vessels.
5. The method according to claim 4, characterized in that the blood vessels are an artery and a vein.
6. The method according to claim 4, characterized in that the blood vessels are a vein and a vein.
7. The method according to claim 4, characterized in that the blood vessels are an artery and an artery.
8. The method according to claim 4, characterized in that a plurality of the extravascular passages are formed between the blood vessels.
9. The method according to claim 1, characterized in that the extravascular passageway is formed for the purpose of deriving a clogged, damaged or diseased segment of a blood vessel.
10. The method according to claim 1, characterized in that the first location is on an artery and the second location is on a vein, in such a way that the blood will flow from the artery, through the extravascular passage, and towards the vein.
11. The method according to claim 10, characterized in that the blood which has been introduced into the vein through the extravascular passageway is subsequently caused to flow through the vein to retroperfuse the tissue through the venous vasculature.
12. The method according to claim 11, characterized in that the blood is caused to flow through the vein to retroperfuse the tissue through the venous vasculature by: b) blocking the vein at a location adjacent to the extravascular passage to cause that blood which flows into the vein through the extravascular passageway subsequently flows through the vein in a direction which will cause retroperfusion of the tissue through the venous vasculature.
13. The method according to claim 1, characterized in that the extravascular passage formed in step a is a primary extravascular passage formed between a first blood vessel and a second blood vessel such that blood having a p02 of at least 50 it will flow from the first blood vessel, through the extravascular passage, and into the second blood vessel.
14. The method according to claim 13, characterized in that the method further comprises the step of: b) forming at least one secondary extravascular passageway between the second blood vessel and another blood vessel of the heart in such a way that the blood that is introduced into the second The blood vessel through the first extravascular catheter will subsequently flow to another blood vessel through the secondary extravascular passageway.
15. The method according to claim 14, characterized in that the blood is caused to flow towards the other blood vessel through the secondary extravascular passageway by: c) blocking the second blood vessel at a location adjacent to the second extravascular passageway to cause the Blood flows from the second blood vessel through the second extravascular passage and back into the other blood vessel.
16. The method according to claim 1, characterized in that at least one of the first and second locations are on a blood vessel which is part of a blood vessel system where a blocked, damaged or diseased segment of a blood vessel is present. .
17. The method according to claim 1, characterized in that step a) of the method is carried out by means of: i) providing a catheter device that forms a passageway, comprising an elongate flexible catheter having a penetrating element of the catheter. tissue that can be passed from it, so that it penetrates through the wall of a blood vessel in which the body of the catheter is inserted; i i: inserting the catheter body into the vasculature and placing the catheter body in such a way that the penetrating element of the tissue is located adjacent to the location at which the extravascular passageway is to be formed; iii; the passage of the penetrating element of the tissue from the euerp: of the catheter to form the extravasable passage according to step a) of the method.
18. The method according to claim 17, characterized in that step i) further comprises: providing an orientation means for locating the first and second locations and for orienting the catheter device such that the penetrating element of the catheter tissue will pass from the first location to the second location, whereby the extravascular passageway is formed between the first location on a blood vessel and the second location on a blood vessel.
19. The method according to claim 17, characterized in that the penetrating element of the fabric of the device provided in step i) furthermore incorporates a lumen through which a guidewire can be passed during the creation of the extravasable passageway per penetration element. of the tissue, and wherein the method is characterized in that it further comprises the step of: passing a guidewire through the lumen and allowing the guidewire to remain extended through the extravascular passage following the extraction and removal of the catheter, for to provide by this the subsequent advancement of one or more other apparatuses through the passageway, over the guidewire.
20. A method of coronary revascularization in a mammalian heart having arteries and veins formed therein, the method is characterized in that it comprises the steps of: providing a catheter for the formation of a passageway, adapted to form an extravascular passageway between two blood vessels; inserting the catheter into a peripheral blood vessel and advancing the catheter into a blood vessel of the heart; using the catheter to form at least one primary extravascular passageway between the blood vessel of the heart in which the catheter is placed and another blood vessel of the heart, such that blood will flow from one of the blood vessels, through the extravascular passageway , and towards the other blood vessel.
21. The method according to claim 20, characterized in that at least one passageway is formed between an artery of the heart and a vein of the heart, such that blood from the artery will flow through at least one of the passageway (s). (s) extravascular (s) to the vein of the heart.
22. The method according to claim 21, characterized in that the arterial blood which has been made to flow from the artery of the heart to the vein of the heart is subsequently caused to flow through the vein to retroperfuse the cardiac tissues through the vasculature. cardiac venous
23. The method according to claim 22, characterized in that the arterial blood is caused to flow through the vein to retroperfuse the cardiac tissue through the cardiac venous vasculature, blocking the flow through the vein in an opposite direction, in a location adjacent to an extravascular catwalk.
'24. The method according to claim 21, characterized in that the method further comprises: using the catheter to form at least one secondary extravascular passageway from the vein of the heart to an artery of the heart in such a way that the arterial blood which has been introduced into the The heart vein will subsequently flow through at least one secondary extravascular passageway and into an artery of the heart, to profuse cardiac tissues through the cardiac arterial vasculature.
25. The method according to claim 20, characterized in that the method is carried out for the purpose of deriving a segment obstructed, damaged or affected by a disease, of an artery of the heart.
26. The method according to claim 25, characterized in that the revascularization is performed in the heart of a mammal having a Circumflex Artery, a Major Coronary, a Anterior Intraventricular Vein and a Anterior Left Descending Artery, for the purpose of deriving a clogged segment. , damaged or affected by the disease, of the Circumflex Artery, where the method also includes: i. form a primary extravascular passageway between the Anterior Left Descending Artery and the Anterior Intraventricular Vein; ii. forming a secondary extravascular passageway between the Coronaria Mayor and the Circumflex Artery in a location downstream of the obstructed segment, damaged or affected by the disease, thereof; and, iii. cause blood to flow from the Anterior Left Descending Artery through the primary extravascular passageway, through the Anterior Intraventricular Vein to the Major Coronary, and through the secondary extravascular passageway to the Circumflex Artery, downstream of the obstructed, damaged, or affected segment by illness, of it.
27. The method according to claim 26, characterized in that step iii) is performed by blocking the lumen of the intraventricular vein. Anterior in a location adjacent to the primary extravascular passage.
28. The method according to claim 27, characterized in that step iii) is further performed by blocking the lumen of the Major Coronary at a location adjacent to the secondary extravascular passageway.
29. The method according to claim 25, wherein the revascularization is performed in the heart of a mammal having a Circumflex Artery, a Major Coronary, a Anterior Intraventricular Vein, and a Anterior Left Descending Artery for the purpose of deriving a clogged segment. , damaged or affected by the disease, of the Anterior Left Descending Artery, the method is characterized because it comprises: i. form a primary extravascular passageway between the Circumflex Artery and the Major Coronary Artery; ii. form a secondary extravascular passageway between the Anterior Intraventricular Vein and the Anterior Descending Artery Left in a location downstream of the obstructed segment, damaged or affected by the disease, thereof; and, iii) cause blood to flow from the Circumflex Artery, through the primary extravascular passageway, through the Coronary Major, into the Anterior Intraventricular Vein, and through the secondary extravascular passage to the Anterior Left Descending Artery, downstream of the Segment obstructed, damaged or damaged by an illness.
30. E i ét .. J "in accordance with claim 29, characterized in that step iii) is performed by blocking the 1-men of the Major Coronary at an adjacent location < _! primary extravascular catwalk
31. The method according to claim 30, characterized in that step iii) is further effected by blocking the lumen of the Anterior Intraventricular Vein at a location adjacent to the secondary extravascular passageway.
32. A method for performing a method in a target location or intracorporeal target within the body of a mammal, the method is characterized in that it comprises the steps of: a) placing, within a blood vessel, a catheter device which comprises: i ) a flexible catheter body having a proximal end and a distal end; ii) a tissue penetrating element that can be passed out of the first location on the catheter body, to form an extravascular passageway which extends from the blood vessel in which the catheter is placed, to a target or target location intracorporal outside the blood vessel; b) orienting the first location of the catheter body relative to the target location or intracorporeal target so that the penetrating element of the tissue can pass out of the first place of the catheter body to form an extravascular passageway between the blood vessel and the blood vessel. target location or intracorporeal target; c) passing the penetrating element of the tissue out of the catheter body to form the extravascular passageway between the blood vessel and the target location or intracorporeal target; and, d) passing at least one apparatus for carrying out the procedure through the extravascular passageway and using the apparatus to carry out the procedure for performing the medical procedure at the target location or intracorporeal target.
33. The method according to claim 32, characterized in that the medical procedure is the supply of a substance that can flow, and wherein the apparatus for carrying out the process comprises a tubular cannula through which the substance can be passed through. which can flow, towards the extravascular location.
34. The method according to claim 32, characterized in that the medical procedure is the implantation of an implantable drug delivery apparatus, and wherein the apparatus for carrying out the procedure is an implant device for passing the delivery apparatus of the drug. drug through the extravascular catwalk and to implant the delivery device in the extravascular location.
35. The method according to claim 32, characterized in that the medical procedure is the implantation of a radioactive material for radiotherapy, and wherein the apparatus for carrying out the procedure is an operative implant apparatus for passing the radioactive material through the extravascular passage and to implant the radioactive material in the extravascular location.
36. The method according to claim 32, characterized in that the medical procedure is the implantation of a stimulator apparatus and wherein the apparatus carrying out the method comprises an implant apparatus for passing the stimulator apparatus through the extravascular passageway and for implant the stimulator device in the extravascular location.
37. The method according to claim 32, characterized in that the medical procedure is the implantation of a sensor apparatus and wherein the apparatus for carrying out the method comprises an implant device to pass the sensing device through the passageway. Extravascular to implant the sensory device in the extravascular location.
38. The method according to claim 32, characterized in that the medical procedure is the implantation of an electrode apparatus and wherein the apparatus for carrying out the method comprises an implant apparatus for passing the electrode apparatus through the extravascular passageway and to implant the electrode apparatus in the extravascular location.
39. The method according to claim 32, characterized in that the medical procedure is the implantation of a transmitting apparatus and wherein the apparatus carrying out the method comprises an implant apparatus for passing the transmitting device through the extravascular passageway and for 'implanting the transmitter aparate in the extravascular location.
40. The method according to claim 32, characterized in that the medical procedure is the implant of a receiving apparatus and wherein the apparatus for carrying out the method comprises an implant apparatus for passing the receiving apparatus through the extravascular passageway and to implant the receptor apparatus in the extravascular location.
41. The method according to claim 32, characterized in that the medical procedure is the implantation of a transponder or answering apparatus and wherein the apparatus carrying out the method comprises an implant apparatus for passing the transponder or answering device through the device. extravascular catheter and to implant the transponder or answering device in the extravascular location.
42. The method according to claim 32, characterized in that the medical procedure is the implant of an apparatus of the support element and wherein the apparatus for carrying out the method comprises an implant apparatus for passing the apparatus of the support element to through the extravascular passage and to implant the apparatus of the support element in the extravascular location.
43. The method according to claim 32, characterized in that the support element is a small tube which is initially deployed in a compact configuration when it is passed through the extravascular passage, and which is subsequently deployed to an operative configuration to impart structural support to at least one anatomical structure located in the extravascular location.
44. The method according to claim 32, characterized in that the medical procedure is the implantation of a marker apparatus and wherein the apparatus for carrying out the method comprises an implant apparatus for passing the marker apparatus through the extravascular passageway and for implant the marker device in the extravascular location.
45. The method according to claim 44, characterized in that the marker is formed of a radiographically visible material.
46. The method according to claim 32, characterized in that the medical procedure is the softening of the tissue, and wherein the apparatus that performs the procedure is a fabric softening apparatus.
47. The method according to claim 32, characterized in that the medical procedure is tissue destruction, and wherein the apparatus that performs the procedure is an apparatus for tissue destruction.
48. The method according to claim 32, characterized in that the medical procedure is the cutting of the tissue, and wherein the apparatus that performs the procedure is a tissue cutting device.
49. The method according to claim 48, characterized in that the medical procedure is the transection of a nerve, and wherein the apparatus that performs the procedure is an apparatus for transection of the nerve.
50. The method according to claim 32, characterized in that the medical procedure is sampling ae ur. biological fluid, and wherein the apparatus that performs the procedure is a cannula through which a sample of biological fluid can be aspirated from the extravascular location.
51. The method according to claim 32, characterized in that the medical procedure is the sampling of a solid matter, and wherein the apparatus that performs the procedure is an apparatus for removing a sample of solid matter from the estravascular location.
52. The method according to claim 51, characterized in that the medical procedure is a tissue biopsy, and wherein the apparatus for carrying out the procedure is an operative biopsy tool for cutting and recovering a segment of tissue from the location extravascular.
53. The method according to claim 32, characterized in that the method further comprises: withdrawing or removing the catheter from the vasculature following carrying out the medical procedure.
54. The method according to claim 32, characterized in that it further comprises: placing a tubular cannula into the extravascular passageway and causing the tubular cannula to remain within the extravascular passage following the removal and removal of the catheter.
55. The method according to claim 54, characterized in that the resident tubular cannula extends from the extravascular location to an intracorporeal location, to drain the fluid from the extravascular location to the second location.
56. The method according to claim 54, characterized in that the resident tubular cannula is accessible from any extracorporeal location to allow the desired material to be delivered through the cannula to the extravascular location.
57. The method according to claim 56, characterized in that the cannula extends through the extravascular passage, and through the vasculature, and is coupled to a subcutaneous injection port which is accessible from an extracorptive location, p-.r__ allow the material that can flow to be injected percutaneously into the injection port and delivered to the extravascular location through the resident cannula.
58. The metede according to claim 53, characterized in that the method further comprises: closing the opening in the blood vessel from which the extravascular catheter was formed, following which the medical procedure is complemented.
59. The method according to claim 58, characterized in that the closing of the opening in the blood vessel is carried out by the deployment of a device for closing the wall of the blood vessel selected from the group of apparatuses consisting of: an emitting device of energy; a cauterization device; a suture device; a device or stapling; an endovascular graft; an endovascular graft with small tubes; a ball; one spool c reel; ribbons of materials that produce coagulation; microfatory collagen; collagen spon; cellulose gel; and combinations thereof.
60. A catheter device insertable into a blood vessel and usable to form an extravascular passageway which extends through the wall of the blood vessel in which the catheter device is inserted, to a target location or intracorporeal target, the device catheter is characterized in that it comprises: a flexible catheter body, characterized in that it has a remote end and a proximal end; a penetrating element of the tissue that can be passed out of the first location of the catheter body to form the extravascular passageway; and, orienting means for determining at least the rotational orientation of the catheter body to facilitate proper placement of the first location of the catheter body such that the subsequent passage of the tissue penetrating element from the catheter body will form the extravascular passageway between the blood vessel and the location of the target or intracorporeal target.
61. The device according to claim 60, characterized in that the first location is an exit opening formed at the far end of the catheter body and the penetrating element of the tissue is passed out of the exit opening, and wherein the penetrating element The tissue is adapted to be bent in a first direction when it passes outside the outlet opening formed at the end remote from the catheter body, to penetrate the wall of the blood vessel in which the catheter has been inserted.
62. The device according to claim 60, characterized in that the first location is an exit opening formed in the side wall of the catheter body, and wherein the penetrating element of the tissue, when passed out of the outlet opening located in the the side wall of the catheter body will penetrate through the wall of the blood vessel into which the catheter has been inserted.
63. The device according to claim 60, characterized in that the penetrating element of the fabric comprises a foldable, elongated needle, having a sharpened remote point and a pre-bent elastic spine element placed therein, the spine element is operative to cause that the folding needle is flexed in the first direction.
64. The device according to claim 60, characterized in that the penetrating element of the fabric is an elongated element which comprises: i) a folding proximal shaft having a far end, and ii) a sharp pointed element formed of a rigid material and mounted on the far end of the foldable proximal shaft.
65. The device according to claim 60, characterized in that the penetrating element of the fabric comprises a pre-bent, elastic element, having a sharp pointed tip.
66. The device according to claim 65, characterized in that the needle is formed of a material which is superelastic when inserted into the body of the mammal.
67. The device according to claim 66, characterized in that the superelastic material is a nickel-titanium alloy.
68. The device according to claim 66, characterized in that the elastic element is a hollow needle having a hollow lumen extending longitudinally therethrough.
69. The device according to claim 66, characterized in that the pre-bent elastic element is a solid needle.
70. The device according to claim 60, characterized in that the tissue penetrating element comprises an elongate element having a trocar tip formed on the remote end thereof, in combination with a tubular sheath or wrapper placed around the needle and movable element. longitudinally relative to the needle element.
71. The device according to claim 60, characterized in that the penetrating element of the fabric comprises an elongated element that has a remote tip that emits energy, formed on it, the remote tip that emits energy is operative to emit energy, which will facilitate the Penetration of the penetrating element of the tissue through the tissue.
72. The device according to claim 60, characterized in that the remote point emitting the energy on the penetrating element of the fabric is selected from the group of energy-emitting apparatus consisting of: a tip heated by a resistance; a monopolar electrocautery tip; a tip of bipolar electrocautery; a tip element emitting ultrasound; and possible combinations thereof.
73. The device according to claim 60, characterized in that the penetrating element of the fabric comprises an elongated element having a far end cor. a rotary tissue cutting apparatus formed thereon.
74. The device according to claim 60, characterized in that the penetrating element of the tejxd is ur. flow of energy that can pass out of the outlet opening formed in the catheter body.
75. The device according to claim 60, characterized in that the energy flow is selected from the group of energy types consisting of: laser light; hot; ultrasound; and, possible combinations thereof.
76. The device according to claim 60, characterized in that the tissue penetration element comprises an elongate element having a lumen extending longitudinally therethrough, the lumen can be connected to a source of negative pressure to stretch the tissue towards the lumen through the far end of the penetrating element of the tissue.
77. The device according to claim 60, characterized in that the penetrating element of the device comprises: a tubular, elastic, pre-folded, having a far end; and, an elongate element having a sharp, tapered tip, the elongated element is positioned within the tubular liner and can be advanced through therethrough, such that the sharpened remote tip will come out of the far end. open lining or wrap; the elongated element is constructed of a material which is sufficiently foldable to conform to the pre-bent configuration of the tubular sheath or envelope.
78. The device according to claim 60, characterized in that it comprises: a sidecar apparatus connected to at least a portion remote from the flexible catheter body, the sidecar apparatus is configured to receive therein a catheter for imaging , such that the catheter for the formation of the images can be used to observe the passage of the penetrating element of the tissue out of the first location on the body of the catheter.
79. The device according to claim 78, characterized in that the lateral carriage is formed of a material which is at least partially impermeable to the energy used by the device for the formation of the images, and wherein the lateral carriage further comprises: window formed in the lateral carriage immediately adjacent to the first location on the catheter body to allow the imaging device to observe the passage of the penetrating element of the tissue out of the first location on the catheter body and through the wall of the catheter. blood vessel in which the catheter is placed.
80. The device according to claim 79, characterized in that the window is positioned in alignment with the direction in which the penetrating element of the tissue will pass during the creation of the extravascular passageway; the window thus comprises at least a portion of the orientation means, the orientation of the first location on the catheter body is controllable by means of this, by rotating the catheter device until an imaging apparatus placed within the The lateral carriage is able to observe the target or target area within which the passageway is to be formed, whereby it is ensured that the catheter device is in an appropriate rotational orientation prior to advancement of the penetrating element of the tissue outside the exit opening.
81. The device according to claim 60, characterized in that the catheter body is formed of a flexible plastic material, and wherein a rigid tubular stiffening element is placed around a lumen portion of the catheter body, adjacent to the opening outlet, to prevent the tissue penetrating element from resting in contact with the collapsible plastic material of the catheter body when the tissue penetrating member is retracted towards the catheter body.
82. The device according to claim 60, characterized in that it further comprises: a hand-piece, mounted on the proximal end of the catheter body, the hand-piece has an actuator button which is connected to the penetrating element of the tissue, the The actuator button may be advanced in a first direction to advance the penetrating element of the tissue out of the exit opening, and retractable in a second direction to retract the penetrating element of the tissue toward the lumen of the catheter body.
83. A system, characterized in that it comprises a catheter device forming the passageway according to claim 60, in combination with: an aparate for imaging which is usable in conjunction with the orienting means to further facilitate proper positioning of the catheter. The first location of the catheter body.
84. The system according to claim 83, characterized in that the apparatus for forming the images is selected from the group of image forming apparatuses consisting of: an ultrasonic imaging apparatus; a Doppler imaging apparatus; an apparatus for forming radiographic images; an apparatus for magnetic resonance imaging; an electromagnetic imaging apparatus; and possible combinations of them.
85. The system according to claim 84, characterized in that the apparatus is an image formation catheter which is separated from the catheter that forms the catwalk.
86. The system according to claim 85, characterized in that the catheter device forming the passageway further comprises a sidecar apparatus connected to at least a portion remote from the flexible catheter body, the sidecar apparatus is configured to receive the catheter for the formation of the images therein, in such a way that the catheter for the formation of the images can be used to observe the passage of the penetrating element of the tissue from the first location on the body of the catheter; and, the catheter for forming the images is located at least partially within the side car apparatus.
87. The system according to claim 84, characterized in that the sidecar apparatus is formed of a material which is at least partially permeable to the energy used by the catheter for the formation of the images, and wherein the sidecar apparatus further comprises: a window formed in the lateral carriage apparatus immediately adjacent to the first location on the catheter body to allow the catheter for the formation of rr.ager.es observe or detect the passage of the penetrating element of the tissue outside the first location on the catheter body and through the blood vessel in which the catheter body is placed; And, the catheter for the formation of the images is located inside the side car adjacent to the window so as to limit the field observed or detected by the catheter for the formation of the images with respect to that which is observable through the window.
88. The system according to claim 87, characterized in that the catheter device forming the passage can be torque applied in such a way that the catheter device can be rotated at will until the catheter for the formation of the images be able to observe the target or target area through the window, whereby it is ensured that the first location on the catheter body is in the correct rotating position prior to the passage of the penetrating element of the tissue outside the first location above. The body of the catheter.
89. The system comprising the catheter device according to claim 58, wherein the penetrating element of the tissue comprises an elongate element having ur. guidewire lumen extending longitudinally therethrough, such that a guidewire can be advanced through the lumen during the formation of the extravascular passageway by the tissue penetrating element, the system is characterized in that it comprises: the catheter device according to claim 58, further in combination with an elongate flexible guidewire, which can be passed through the guidewire lumen of the tissue penetrating element.
90. A longitudinal compression apparatus usable for longitudinally compressing the tissue surrounding the openings formed in the first and second tubular anatomical ducts having lumens, wherein the first and second tubular anatomical ducts are in collateral juxtaposition with each other in such a way that the openings are in alignment with each other, the longitudinal compression apparatus is characterized in that it comprises: a first portion that can be placed in abutting contact with the luminal surface of the first anatomical tubular conduit that surrounds the opening therein; a second portion that can be placed in abutting contact with the luminal surface of the second tubular anatomical duct that surrounds the opening formed therein; means for connecting the first and second portions together, for longitudinally compressing the tissue which surrounds the aligned openings of the first and second anatomical conduits and any extravascular tissue interposed therebetween.
91. The longitudinal compression apparatus according to claim 90, characterized in that the first and second portions comprise annular elements can be placed in abutting contact with the luminal surfaces.
92. The longitudinal compression apparatus according to claim 90, characterized in that the first and second portions comprise opposite ends of the elongated wire elements formed in a cylindrical array or network extending through the first and second openings, the opposite ends of the wire elements are bent outwards to make butt contact against and to couple the luminal surfaces of the first and second anatomical conduits.
93. The longitudinal compression apparatus according to claim 92, characterized in that the wire elements are pre-bent, elastic wire elements, which, when placed within the first and second openings and free of external stresses, will assume the bent configuration.
94. The longitudinal compression apparatus according to claim 92, characterized in that the wire elements are elastically deformable, and wherein the device further comprises a tool that exerts pressure, which is operative to bend the opposite ends of the wire elements afterwards. that the wire elements have been placed within the first and second openings.
95. A catheter device insertable into a blood vessel and usable to form an extravascular passageway which extends through the wall of the blood vessel in which the catheter device is inserted, to a target location or intracorporeal target, the device catheter is characterized in that it comprises: a flexible catheter body having a proximal end and a remote end; a tissue penetrating element that can be passed out to a first location on the catheter body, to form the extravascular passageway; the penetrating element of the tissue comprises an elongate element having a lumen of guidewire extending longitudinally therethrough, such that a guidewire can be advanced through the lumen of the guidewire during the formation of the extravascular passageway by the penetrating element of the tissue.
96. A system, characterized in that it comprises the catheter device according to claim 95, in combination with: a guide wire which can be passed through the lumen of the guidewire.
97. The device according to claim 95, characterized in that the first location is an exit opening formed at the end remote from the catheter body and the penetrating element of the tissue can be passed out of the exit opening, and wherein the element The tissue penetrant is adapted to flex in a first direction when it passes outside the exit opening formed at the far end of the catheter body, to thereby penetrate the wall of the blood vessel in which the catheter has been inserted. .
98. The device according to claim 95, characterized in that the first location is an exit opening formed in the side wall of the catheter body, and wherein the penetrating element of the tissue, when passed out of the outlet opening located in the the lateral wall of the catheter body will penetrate through the wall of the blood vessel into which the catheter has been inserted.
99. The device according to claim 95, characterized in that the penetrating element of the fabric comprises an elongated foldable needle, having a sharpened remote tip and a pre-bent elastic spine element, placed therein, the spine element is operative for cause the folding needle to bend in the first direction.
100. The device according to claim 95, characterized in that the penetrating element of the fabric is an elongated element comprising: i) a folding proximal shaft having a far end, and ii) a sharp pointed element formed of a material rigid and mentioned on the far end of the folding proximal shaft.
101. The device according to claim 95, characterized in that the penetrating element of the fabric comprises a pre-bent, elastic element, having a sharpened remote tip.
102. The device according to claim 101, characterized in that the needle is formed of a material which is superelastic when inserted into the body of a mammal.
103. The device according to claim 101, characterized in that the superelastic material is a nickel-titanium alloy.
104. The device according to claim 101 characterized in that the elastic pre-bent element is a hollow needle having a hollow lumen extending longitudinally therethrough.
105. The device according to claim 101, characterized in that the predcbladc elastic element is a solid needle.
106. The device according to claim 95, characterized in that the tissue penetrating element comprises an elongate element having a trocar tip formed on the remote end thereof, in combination with a tubular sheath or wrapper placed around the needle element and longitudinally movable relative to the needle element.
107. The device according to claim 95, characterized in that the penetrating element of the fabric comprises the elongated element having a remote tip that emits energy, formed on it, the remote tip that emits energy is operative to emit the energy which will facilitate the penetration of the penetrating element of the tissue, through the tissue.
108. The device according to claim 95, characterized in that the remote tip that emits the energy on the tissue penetrating element is selected from the group of energy emitting apparatuses consisting of: a tip heated by resistance; a monopolar electrocautery tip; a tip of bipolar electrocautery; a tip element emitting ultrasound; and, possible combinations thereof.
109. The device according to claim 95, characterized in that the penetrating element of the fabric comprises the elongated element having a far end with a rotating tissue cutting apparatus formed thereon.
110. The device according to claim 95, characterized in that the tissue penetrating element comprises the elongate element in combination with a flow of energy emissible from the elongate element to assist the elongate element in penetration through the tissue.
111. The device according to claim 95, characterized in that the energy flow is selected from the group of energy types consisting of; a laser light; hot; ultrasound; and possible combinations of them.
112. The device according to claim 95, characterized in that the penetrating element of the tissue comprises the elongated element having a suction lumen extending longitudinally therethrough, the suction lumen is connectable to a source of negative pressure to extract the tissue towards the suction lumen through the far end of the elongated element.
113. The device according to claim 95, characterized in that the penetrating element of the fabric comprises: a tubular, elastic, pre-bent tubular liner having an open remote end; and, the elongated element has a sharp pointed tip, the elongated element is positioned within the tubular sheath or envelope and can be advanced therethrough, such that the sharp pointed tip will come out of the open end of the sheath or wrap; The elongated element is constructed of a material which is sufficiently foldable to conform to the pre-bent configuration of the tubular liner or shell.
114. The device according to claim 95, characterized in that it further comprises: a sidecar apparatus connected to at least a portion remote from the flexible catheter body, the sidecar apparatus is configured to receive therein a catheter for the formation of images in such a way that the catheter for the formation of the images can be used to observe the passage of the tissue penetration element out of the first location on the catheter body.
115. The device according to claim 114, characterized in that the lateral carriage is formed of a material which is at least partially impermeable to the energy used by the device for the formation of the images, and wherein the lateral carriage further comprises: window formed in the lateral cart immediately adjacent to the first location on the catheter body to allow the device for image formation to observe the passage of the penetrating element of the tissue out of the first location on the body of the catheter and through the wall of the blood vessel in which the catheter is placed.
116. The device according to claim 15, characterized in that the window is positioned in alignment with the direction in which the penetrating element of the tissue will pass during the creation of the extravascular passageway; the window thus comprises at least a portion of the orientation means, the orientation of the first location on the catheter body is controllable by means of this by rotating the catheter device until an imaging apparatus placed inside the side car is able to observe the target or target area within which the passageway is to be formed, whereby it is ensured that the catheter device is in the proper rotational orientation prior to advancement of the penetrating element of the tissue outside the opening of the catheter. departure.
117. The device according to claim 95, characterized in that the catheter body is formed of a flexible plastic material and wherein a rigid tubular reinforcing element is placed around a portion of the lumen of the catheter body, adjacent to the opening of the catheter. outlet, to prevent the tissue penetrating element from resting in contact with the collapsible plastic material of the catheter body when the penetrating element of the tissue is retracted towards the catheter body.
118. The device according to claim 95, characterized in that it further comprises: a hand-piece, mounted on the proximal end of the catheter body, the hand-piece has an actuator button which is connected to the penetrating element of the tissue, the The actuator button can be advanced in a first direction to advance the tissue penetrating element out of the exit opening, and retractable in a second direction to retract the tissue penetrating element toward the lumen of the catheter body.
119. The device according to claim 95, characterized in that it further comprises: orientation means for determining at least the rotational orientation of the catheter body to facilitate proper positioning of the first location on the catheter body such that the subsequent catheter The penetrating element of the tissue will form the extravasable passageway between the blood vessel and the location of target or etiology in the body.
120. A system, characterized in that it comprises the catheter device forming the passageway according to claim 119, in further combination with: an image forming apparatus which is usable in conjunction with the orienting means to further facilitate proper positioning of the catheter. The first location on the catheter body.
121. The system according to claim 120, characterized in that the apparatus for forming the images is selected from the group of apparatuses for the formation of the images consisting of: an ultrasonic imaging apparatus; a Doppler imaging apparatus; an apparatus for forming radiographic images; an apparatus for magnetic resonance imaging; an electromagnetic imaging apparatus; and, possible combinations thereof.
122. The system according to claim 121, characterized in that the apparatus for the formation of the images is located on a catheter for the formation of the images, which is separated from the catheter for the formation of the passageway.
123. The system according to claim 122, characterized in that the catheter device forming the passageway further comprises a sidecar apparatus connected to at least a portion remote from the body of the flexible catheter, the sidecar apparatus is configured to receive inside the same the catheter for the formation of the images, in such a way that the catheter for the formation of the images can be used to observe the passage of the penetration element of the tissue from the first location on the body of the catheter; and, the catheter for forming the images is located at least partially within the side car apparatus.
124. The system according to claim 121, characterized in that the lateral carriage apparatus is formed of a material which is at least partially permeable to the energy used by the catheter for the formation of the images, and wherein the lateral carriage apparatus further comprises: a window formed in the lateral cart apparatus immediately adjacent to the first location on the catheter body to allow the catheter for image formation to observe or detect the passage of the tissue penetrating element out of the first location on the catheter body and through the wall of the blood vessel in which the body of the catheter is located; and, the catheter for the formation of the images is located within the lateral carriage adjacent to the window to limit the field observed by the catheter for the formation of the images with respect to that which is observable or detectable through the window.
125. The system according to claim 124, characterized in that the catheter device forming the passage can be torque applied in such a way that the catheter device can be rotated at will until the catheter for the formation of the images be able to observe or detect the target and target area through the window, whereby it is ensured that the first location on the catheter body is in the correct rotating position prior to passage of the penetrating element of the tissue outside the first location on the body of the catheter.
MXPA/A/1998/002870A 1995-10-13 1998-04-13 Methods and apparatus for deriving arterial obstructions and / or carrying out other transvascular procedures MXPA98002870A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US005164 1995-10-13
US010614 1996-02-02

Publications (1)

Publication Number Publication Date
MXPA98002870A true MXPA98002870A (en) 1999-05-31

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