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WO2015036979A2 - Système de fil guide à formation de boucle commandable - Google Patents

Système de fil guide à formation de boucle commandable Download PDF

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Publication number
WO2015036979A2
WO2015036979A2 PCT/IB2014/064520 IB2014064520W WO2015036979A2 WO 2015036979 A2 WO2015036979 A2 WO 2015036979A2 IB 2014064520 W IB2014064520 W IB 2014064520W WO 2015036979 A2 WO2015036979 A2 WO 2015036979A2
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
distal end
control tube
control
loop
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2014/064520
Other languages
English (en)
Other versions
WO2015036979A3 (fr
Inventor
Assaf Klein
Hadar GILBOA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MEDIVALVE Ltd
Original Assignee
MEDIVALVE Ltd
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 MEDIVALVE Ltd filed Critical MEDIVALVE Ltd
Publication of WO2015036979A2 publication Critical patent/WO2015036979A2/fr
Publication of WO2015036979A3 publication Critical patent/WO2015036979A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/0915—Guide wires having features for changing the stiffness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • Embodiments of the invention relate to guidewires which may be used in surgical procedures.
  • a guidewire is a thin, typically flexible wire that can be inserted into an anatomical lumen (channel or opening) of an animal, typically a human, such as an intestine, a vein or an artery.
  • a guidewire may assist in insertion, placement and removal of other medical devices such as catheters, endoscopes, stents and replacement valves.
  • Guidewires are commonly used in a number of surgical and diagnostic procedures including but not limited to gastrointestinal, urinary and cardiac procedures.
  • PAVR percutaneous aortic valve replacement
  • a risk associated with use of guidewires in humans is the potential of a distal tip of the guidewire puncturing soft tissue as it is advanced within the human's body.
  • advancement of a guidewire that has reached a patient's left ventricle may puncture the soft tissue of the left ventricle, leading to injury or even death.
  • One of the ways that guidewires have been modified to reduce such a risk is by manufacturing guidewires with a pre-formed curve, also known as a J-tip, at the distal end of the guidewire, or by pre-shaping the distal end of the guidewire before use in a catheterization laboratory.
  • An aspect of an embodiment of the invention relates to providing a controllable guidewire system configured to form a loop, preferably a closed loop, at its distal end upon entering a region of a lumen to prevent puncturing of soft tissue by the guidewire.
  • the loop may be easily adjustable in size and shape to form a loop or loops of varying sizes and shapes by the operator to be lodged in a region of a lumen in a secure fashion.
  • a guidewire may be formed of a material having regions of varying flexibility along its length. Regions of increased flexibility may be configured to bend in order for the guidewire to form a loop having an appropriate size to be securely lodged in a lumen of an animal, thereby preventing the distal advancement of the guidewire.
  • distal refers to a direction away from the opening in the body along the axis of the main portion of the guidewire after being inserted into the body.
  • proximal refers to a direction towards the opening in the body along the axis of the main portion of the guidewire after being inserted into the body.
  • a guidewire is configured to form a loop at its distal end, the loop configured for lodging a distal portion of the guidewire securely in a lumen, for instance in a terminus of a lumen, such as the left ventricle of a patient, thereby preventing advancement of the guidewire in the distal direction.
  • the guidewire may then be used to assist in maneuvering a device to the lumen.
  • the guidewire may assist in performing a medical or diagnostic procedure, such as PAVR.
  • Guidewires according to embodiments of the invention provide more stability and allow for accurate placement and positioning, relative to guidewires that have been previously described in the prior art. These guidewires may reduce risk of life threatening complications of catheterization procedures, such as ventricular perforation or mitral valve damage. Often, practitioners must apply significant force on a guidewire in the distal direction when performing medical or diagnostic procedures, in order to gain improved stability to introduce medical devices such as delivery systems using the guidewire.
  • Embodiments of the invention comprising guidewires configured to form a closed loop, avoid the above-mentioned risks, even when a practitioner applies significant force on the guidewire in the distal direction.
  • a lumen of a given patient may differ in size than a corresponding lumen in another patient. For instance, a patient having a large body size may have a left ventricle larger than the left ventricle of a patient having a smaller body size.
  • termini of lumens may vary in shape from patient to patient.
  • a single guidewire may comprise multiple regions of increased flexibility, each region configured to bend to form a loop of a unique dimension, thereby enabling a user of the guidewire, such as a medical practitioner performing a procedure, to choose a region of the guidewire to bend to form a loop suitable for use in a patient's lumen, depending upon the size of a patient's lumen.
  • the loop-forming regions of the guidewire may be marked with a radio opaque marking which may enable a practitioner to easily image the guidewire to ensure proper placement of the loop and/or the guidewire.
  • a loop-forming guidewire system may comprise a guidewire having at least one area of increased flexibility, a control tube external to the guidewire, and a control wire having two ends, the distal end connected to the distal end of a guidewire and the proximal end configured to be located external to the patient.
  • Motion of the control wire in the proximal direction relative to the guidewire may bend a region of increased flexibility of a guidewire to form a circular or oval shaped loop which can then be securely lodged in a lumen of an animal through distal advancement of both the control wire and the guidewire.
  • control tube may comprise a control portal which may be an aperture in proximity to the distal end of the control tube.
  • the control wire may be threaded through the control tube from its proximal end until the control portal, through which the control wire exits the control tube.
  • the control wire at or near its distal end, may be attached to the distal end of the guidewire.
  • a loop-forming guidewire system may comprise a guidewire having at least one area of increased flexibility, a control tube external to the guidewire, and a control wire having two ends, one distal end connected to the distal end of a guidewire or at a specific distance from the distal end and another end pivotably tethered to an area close to the distal end of the control tube.
  • Motion of the guidewire in the distal direction relative to the control tube for example pulling of the control tube and/or the control wire relative to the guidewire, may bend a region of increased flexibility of the guidewire to form a loop which may be securely lodged in a lumen of an animal by distal advancement of both the guidewire and the control tube.
  • a hollow guidewire having an aperture in proximity to its distal end may be used to convey a control wire from a proximal end of the guidewire to the distal area of the guidewire.
  • the control wire may exit the guidewire through the aperture and connect to the distal area of the guidewire to form a loop capable of assisting in positioning the guidewire.
  • cardiovascular structures such as vessels, arteries, veins, branches, occlusions, blockages, chambers and valves may be imaged or treated.
  • Gastrointestinal structures such as the throat, esophagus, stomach, duodenum, intestines, colon and blockages therein may also be imaged or treated.
  • Pulmonary structures such as trachea, bronchi and thorax may also be imaged or treated.
  • Uro-gynecological structures such as the ureter, bladder, cervix, uterus, fallopian tubes and blockages may also be imaged or treated.
  • other medical devices may be positioned with guidewire systems according to embodiments of the invention including but not limited to, stents, catheters, balloon catheters, pace makers, radioactive medicines, therapeutics, cameras, laparoscopes, endoscopes and sterilization devices.
  • Guidewire systems may be used to direct laparoscopic or endoscopic surgery or to visualize target anatomical structures with directed energy therapies such as radiation therapy.
  • FIG. 1 shows a prior art guidewire introduced into a left ventricle via an aorta
  • FIG. 2A-2E schematically show guidewire systems according to embodiments of the invention
  • Figs. 3A-3C schematically show guidewire systems according to embodiments of the invention
  • FIG. 4 schematically shows a guidewire system according to embodiments of the invention
  • FIGs. 5A-5D schematically show deployment of guidewire systems according to embodiments of the invention.
  • FIG. 6A shows a prior art guidewire introduced into a left ventricle
  • FIGs. 6B and 6C show deployment of a guidewire system in a left ventricle according to embodiments of the invention.
  • FIGs. 7A and 7B show a guidewire system comprising a hollow guidewire, according to embodiments of the invention.
  • FIG. 1 depicts a prior art guidewire 110 introduced into a left ventricle 100 of a human heart.
  • the guidewire is introduced through the aorta and aortic valve 120 to the left ventricle.
  • Guidewire 110 has a curved distal end 130 which curves along the apex of the left ventricle.
  • FIG. 2A schematically depicts a guidewire system 10 according to embodiments of the invention.
  • Guidewire system 10 comprises a control tube 20, a guidewire 30, a control wire 36.
  • Control tube 20 has a proximal end 12.
  • Guidewire 30 comprises a distal end 34.
  • Guidewire 30, control wire 36 and control tube 20 may each be formed from one or a combination of the following: metals such as stainless steel, shape memory alloys, superelastic alloys, titanium alloys, surgical steel, zirconium alloys, niobium alloys, tantalum alloys, polymers or other flexible and medically safe materials.
  • metals such as stainless steel, shape memory alloys, superelastic alloys, titanium alloys, surgical steel, zirconium alloys, niobium alloys, tantalum alloys, polymers or other flexible and medically safe materials.
  • guidewire 30, control wire 36 and control tube 20 may each individually be formed in a wire or tubular formation, having a circular cross section, or in a strip formation, having a flat or oblong formation.
  • guidewire 30 may have a diameter of between about 0.4 to about 0.9 mm (millimeters). According to an embodiment of the invention, the diameter is between 0.4 to 0.65 mm.
  • Guidewire 30 may have a distal tip enlarged relative to the remainder of the guidewire. The distal tip may have a diameter of about 0.7 - 2 mm, preferably about 0.9 mm.
  • control wire 36 may have a diameter of between about 0.04 to about 0.4 mm, preferably between about 0.06 to about 0.15 mm.
  • the control wire may have a strip-like cross section with a thickness of about 0.02 to about
  • control tube 20 may have an inner diameter of between about 0.5 to about 0.7 mm.
  • the outer diameter may be about 0.9 mm.
  • Guidewire 30 may be configured to be slidably attached to control tube 20.
  • Control tube 20 is configured to be external to guidewire 30.
  • guidewire 30 may slide, with low friction, through control tube 20.
  • Guidewire 30 may be controlled by pulling or pushing relative to control tube 20 at control tube's proximal end 12.
  • Guidewire 30 may comprise an increased flexibility area 32.
  • the increased flexibility area may have lower resistance to bending and deforming than other areas of guidewire 30.
  • a guidewire 30 may comprise multiple increased flexibility areas.
  • Flexibility of area 32 may be increased relative to other regions of guidewire 30 using a number of possible modifications including, but not limited to: decreased diameter, modified shape (such as flat or oval cross-section as opposed to round cross section), and modified material.
  • area 32 may be formed of another, more flexible material than the material used to form other sections of guidewire 30 or from a combination of different materials or manufacturing processes.
  • Guidewire 30 may be formed from separate materials for example, a thin nickel-titanium core and covered with a stainless steel coil.
  • control tube 20 may have areas of increased flexibility (not shown) at or in the vicinity of its distal end, in order to provide flexibility to assist in loop formation.
  • Guidewire 30 may be pivotably attached to control wire 36 at distal end 34.
  • control wire 36 is thinner than guidewire 30.
  • Guidewire 30 and control wire 36 may be two sections of one wire having two ends, the wire folded over so that each end extends to the proximal end 12 of control tube 20.
  • guidewire 30 and control wire 36 may be connected at or in proximity to their respective distal ends using welding, soldering or gluing.
  • guide wire system 10 may be introduced into a body, such as a human body, using a guiding catheter system having dimensions adapted for introduction through the body, for example, through the cardiovascular system and passage to a relevant lumen of a patient.
  • the relevant lumen is the left ventricle. The catheter may then be removed from the patient.
  • a radio-opaque marker may be affixed in proximity to the distal end of guidewire system 10 in order to assist in imaging the guidewire system.
  • a radio-opaque marker may comprise a radio-opaque metal such as gold, platinum or tantalum.
  • control wire 36 may be pulled in the proximal direction (relative to control tube 20) thereby bending area 32 to begin to form a loop as shown in Fig. 2B. As shown in Fig. 2C, continued pulling of control wire 36 continues to bend area 32 to form a loop.
  • the size and geometry of the loop now can be controlled by pushing or releasing the control wire or pulling or pushing the control tube 20. For example, pulling the control wire in the proximal direction extends the size of the loop and makes it more elliptical. Size and shape of the loop may be modified to make it more round by pushing the control tube.
  • Guidewire system 10 upon formation of the loop, may be placed in a lumen such as a left ventricle (not shown) by distal motion of guidewire 30 or of guidewire system 10.
  • the loop formed by area 32 upon contact with an extended surface of a tissue surrounding a lumen such as the apex of a left ventricle, prevents damage to the tissue, even if guidewire system 10 is forcibly pushed in the distal direction.
  • the positioning of the loop against a large surface area of the tissue may also stabilize the position of guidewire 30 thereby enhancing accuracy of imaging and/or therapy associated with guidewire 30.
  • a loop formed by guidewire 30 may be elliptical in shape.
  • the long axis of the ellipse has a diameter of about 20-100 mm and a short axis of about 10-60 mm.
  • FIG 2D schematically depicts a guidewire system 10' according to embodiments of the invention.
  • Guidewire system 10' comprises a control tube 20, a guidewire 30, a control wire 36.
  • Guidewire 30 may be attached to control wire 36 at a point 34' which is situated proximally from the distal end of guidewire 30.
  • Control wire 36 may be pulled in the proximal direction (relative to control tube 20) thereby bending area 32 to form a loop.
  • Guidewire system 11 comprises two control wires, 36 and 36' connected to distal end 34 and to point 34' respectively.
  • a loop may formed by pulling one or both of control wires 36 and/or 36' proximally relative to guidewire 30 thereby bending area 32 to form a loop (not shown).
  • Shape of the loop may be conformed by proximal motion of one or both of control wires 36 and 36', bending guidewire 30 to fit in a terminus of a lumen of a patient (not shown).
  • a guidewire system comprises 2, 3, 4, 5 or more control wires.
  • Figs. 3A, 3B, 3C and 4 depict guidewire systems according to some embodiments of the invention.
  • a guidewire system 40 comprising a guidewire 44, the guidewire having a distal end 48 and an area 46, the area having increased flexibility relative to the remainder of guidewire 44.
  • Guidewire system 40 further comprises a control tube 42, a control wire 50.
  • Control tube 42 comprises an anchor 52.
  • Control tube 42 may be configured to allow guidewire 44 to slide through it.
  • Control wire 50 may be pivotably attached at one end to anchor 52 and at the other end to distal end 48 to allow for flexing of guidewire 44.
  • Guidewire system 40 may be inserted into the body of a patient in a relatively collapsed position, as depicted in Fig. 3A. This may be accomplished by simultaneously advancing guidewire 44 with control tube 42. Upon reaching a relevant lumen (not shown), guidewire 44 may be advanced in the distal direction relative to the control tube 42, either through pushing guidewire 44 distally or pulling control tube 42 proximally, thereby flexing area 46 to form a loop (loop is not shown). The loop may be advanced to be lodged in a relevant terminus of a lumen by simultaneously advancing both guidewire 44 and control tube 42.
  • the loop may then be removed by moving guidewire 44 in the proximal direction relative to the control tube 42, thereby straightening flexible area 46.
  • Guidewire system 40 may then be in a significantly collapsed position to allow removal from the body of a patient.
  • a guidewire system 41 comprising a guidewire 44, the guidewire having a connection point 49 located at a flexible area 46, the flexible area having increased flexibility relative to the remainder of guidewire 44.
  • Guidewire system 41 further comprises a control tube 42 and a control wire 50.
  • Control tube 42 comprises an anchor 52.
  • Control tube 42 may be configured to allow guidewire 44 to slide through it.
  • Control wire 50 may be pivotally attached at one end to anchor 52 and at the other end to connection point 49 to allow for flexing of guidewire 44.
  • Guidewire system 41 may be inserted into the body of a patient in a relatively collapsed position, as depicted in Fig. 3B. This may be accomplished by simultaneously advancing guidewire 44 with control tube 42. Upon reaching a relevant lumen (not shown), guidewire 44 may be advanced in the distal direction relative to control tube 42, either through pushing guidewire 44 distally or pulling control tube 42 proximally, thereby flexing area 46 to form a loop (not shown). The loop may be advanced to be lodged in a relevant terminus of a lumen by simultaneously advancing both guidewire 44 and control tube 42.
  • the loop may then be removed by moving guidewire 44 in the proximal direction relative to control tube 42, thereby straightening area 46.
  • Guidewire system 41 may then be in a significantly collapsed position to allow for easy removal from the body of the patient.
  • a guidewire system 53 comprising a guidewire 59, control wires 58 and 54 and control tube 61.
  • Control tube 61 comprises anchors 52 and 55 to anchor control wires 58 and 54 respectively.
  • Guidewire 59 has a distal end 57 and a connection point 56.
  • Control wire 58 is attached to anchor 52 and to distal end 57.
  • Control wire 54 is attached to connection point 56 and to anchor 55.
  • Guidewire system 53 may be inserted into the body of a patient in a relatively collapsed position (not shown), by simultaneously advancing guidewire 59 with control tube 61.
  • guidewire 59 may be advanced in the distal direction relative to the control tube 61, either through pushing guidewire 59 distally or pulling control tube 61 proximally, thereby flexing guidewire 59 to form a loop.
  • the loop may be advanced to be lodged in a relevant terminus of a lumen (not shown) by simultaneously advancing both guidewire 59 and control tube 61.
  • Fig. 3C shows guidewire system 53 configured in a loop configuration. Stability and shape of loop may be maintained by 2 control wires 54 and 58.
  • multiple control wires may connect between various positions on the guidewire and the control tube.
  • a guidewire system may be equipped with 2, 3, 4, 5 or 6 control wires.
  • a guidewire system may comprise one or more control wires connecting between a guidewire and a control tube and one or more control wires connected to the guidewire at or near its distal end and threaded through a control tube to the vicinity of the guidewire 's proximal end.
  • Figure 4 depicts a guidewire system 60 comprising a guidewire 64, a control tube 62, an area 66, the area 66 having increased flexibility relative to the remainder of guidewire 64, a distal end 68, a control wire 70 and a control portal 72.
  • Guidewire 64 is configured to be slidable within control tube 62.
  • Control wire 70 is attached to distal end 68 and proceeds from distal end 68 in the proximal direction through control portal 72 through the proximal end of control tube 62.
  • Guidewire system 60 may be inserted into the body of a patient in a relatively collapsed position (as shown in the figure), by simultaneously advancing guidewire 64 with control tube 62 and control wire 70.
  • control wire 70 may be pulled in the proximal direction, relative to control tube 62 and guidewire 64.
  • Control wire 70 moves in the proximal direction, through control portal 72 thereby flexing area 66 to form a loop (not shown).
  • the loop may then be pushed in the distal direction, by moving the control tube 62, guidewire 64 and control wire 70 simultaneously distally, to be lodged in a terminus of a lumen, such as the apex of a left ventricle (not shown).
  • Figs. 5A, 5B, 5C and 5D show a guidewire system 80 according to embodiments of the invention.
  • Guidewire system 80 comprises a control tube 78, a guidewire 82, and a control wire 96.
  • Guidewire 82 is connected to control wire 96 at the guidewire's distal end 98.
  • Guidewire 82 comprises flexible regions 84, 88 and 92.
  • Flexible regions 84, 88 and 92 have more flexibility than other regions of guidewire 82.
  • Flexible regions 84 and 88 are separated by region 86.
  • Flexible regions 88 and 92 are separated by region 90.
  • a region 94 is distally located relative to flexible region 92.
  • guidewire system 80 may be introduced to the proximity of a lumen (not shown) in a configuration substantially as depicted in Fig. 5A.
  • a guidewire system may have multiple regions of increased flexibility, for example, 2, 3, 4 ...10 such regions. The different regions of increased flexibility may be similar in size or different in size from eachother.
  • Flexible regions 92, 88 and 84 of guidewire 82 differ in size compared to one another.
  • a practitioner may introduce a guidewire system 80 into a lumen and simultaneously extend guidewire 82 and control wire 96 distally until part of guidewire 82 protrudes distally of control tube 78, comprising flexible region 92.
  • a loop may be formed by flexible reginon 92 by pulling control wire 96 proximally relative to guidewire 82 and control tube 78. Such a loop is depicted in Fig. 5B.
  • the practitoner may further pull control wire 96 in the proximal direction relative to guidewire 82 and control tube 78, thereby straightening the loop and pulling flexible region 92 into control tube 78.
  • a loop may then be formed using flexible region 88 by manipulating guidewire 82 as described above.
  • a configuration of such a loop formed is shown in figure 5C. If such a loop is too small to properly fit in a relevant terminus of a lumen in a patient (not shown), the practitioner may pull control wire 96 in the proximal direction as described above and may form a loop from flexible region 84 as described above, as depicted in Fig. 5D. If such a loop properly fits in a relevant terminus of a lumen in a patient (not shown), guidewire 82 may be employed to perform a diagnostic or interventional procedure. Upon completion of the procedure, the practitioner may move guidewire 82 and control wire 96 proximally relative to control tube 78 to collapse the loop formed by flexible region 84. Guidewire system 80 may then be removed from the patient's body.
  • FIG. 6 A shows a prior art guidewire 142 introduced into a left ventricle 140 of a human heart.
  • the plane of the aortic valve is shown as a dotted line 144.
  • Guidewire 142 having a J-tip is introduced via aorta 146 through the aortic valve into left ventricle 140.
  • guidewire 142 passes through a plane of the aortic valve (not indicated in the figure) in a configuration which is not normal to the plane.
  • placement of a replacement aortic valve using guidewire 142 may be faulty due to the positioning of guidewire 142 relative to the aortic valve plane.
  • Fig. 6B and 6C show deployment of a guidewire system 150 in a left ventricle 140 of a human heart according to embodiments of the invention.
  • guidewire system 150 comprises guidewire 156, control tube 148 and control wire 152.
  • Control wire 152 has a distal end 154.
  • guidewire system 150 may be in a non-centered position relative to the center of aortic valve, as shown in Fig. 6B. Additionally a guidewire system 150 may be configured in a position to be not normal to the plane formed by the aortic valve.
  • Introduction of guidewire system 150 may be performed by introducing control tube 148 into an entrance to left ventricle 140 in a collapsed position (not shown).
  • Guidewire 156 may be extended in the distal direction relative to control tube 148, while moving control wire 152, which is connected to distal end 154, in the proximal direction to form a loop.
  • the loop may be positioned in the apex of the left ventricle as shown in Fig. 6B.
  • guidewire 156 may comprise a relatively stiff section 158 and a flexible region 160, having increased flexibility relative to section 156 and to the section of guidewire 156 proximal to flexible section 160.
  • control wire 152 may be pulled proximally relative to guidewire 156 and control tube 148.
  • Position of guidewire 156 may be adjusted as flexible region 160 may be pulled from a wall of the left ventricle to an orientation normal and centrally located within a plane of the aortic valve, as designated by dotted line 144.
  • the normal and centrally located positioning is useful in proper placement of a replacement aortic valve, in an axis normal and centered relative to the plane of the aortic valve or the annulus of the aortic valve.
  • guidewire system 150 may be removed by pulling guidewire 156 relative to control tube 148 to retract into control tube 148, and subsequently removing control tube 148 from the patient.
  • FIGs. 7A and 7B show guidewire systems 170 and 171 respectively.
  • Fig. 7A shows a guidewire system 170 which comprises a hollow guidewire 172, an aperture 174, a control wire 176.
  • Hollow guidewire 172 comprises a flexible region 180 towards its distal end 178, and a connection point 182.
  • Control wire 176 may be configured to enter hollow guidewire at its proximal end (not shown) and proceed to aperture 174, at which point it exits hollow guidewire 172, and enters distal end 178 and continues in hollow guidewire 172 to connection point 182, at which point it is affixed to hollow guidewire 172.
  • guidewire 172 may be configured in "flat mode" in which control wire 176 is parallel to hollow guidewire 172, and flexible region 180 is relatively straight (configuration not shown.)
  • guidewire system 170 may be introduced into a human body, through, for example, a catheter to reach a location of interest for a diagnostic or medical interventional procedure, for example, a terminus of a lumen such as the left ventricle.
  • control wire 176 may pull control wire 176 from its proximal end, thereby bending flexible region 180 to form a loop.
  • a closed loop formed by control wire 176 and hollow guidewire 172 is shown in Fig. 7A.
  • guidewire system 171 is shown, which further comprises control tube 186.
  • Hollow guidewire 172 may be advanced distally through control tube 186.
  • an operator of guidewire system 171 may pull control wire 176 in the proximal direction from its proximal end, thereby bending flexible region 180 to form a loop, as shown in Fig. 7B.
  • Distal motion of control tube 186 relative to hollow guidewire 172 and control wire 176 may further flex flexible region 184, forming a loop of a desired size.
  • the formed loop may then be lodged in a terminus of a lumen such as an apex of a left ventricle.
  • a guidewire system comprising: a control tube having a lumen, distal and proximal ends, and dimensioned so that with the proximal end outside a body the control tube may be inserted into the body to position the distal end inside the body; a flexible guidewire having a distal end characterized by elasticity that varies as a function of distance from the distal end that is pushable through the control tube to protrude the distal end outside the distal end of the control tube; and a control wire connected to the guidewire distal end and slidable in the control tube to control a radius of curvature of the distal end of the guidewire when the guidewire distal end protrudes outside the control tube distal end.
  • the cross section of the guidewire varies as a function of distance from the end of the guidewire to provide the elasticity that varies as a function of distance from the distal end of the guidewire.
  • a composition of the material in the guidewire varies to provide the elasticity that varies as a function of distance from the distal end of the guidewire.
  • the microstructure of the guidewire varies as a function of distance from the end of the guidewire to provide the elasticity that varies as a function of distance from the distal end of the guidewire.
  • the control wire exits the control tube through an aperture in the wall of the tube.
  • control wire extends through the distal end of the control tube when the distal end of the guidewire protrudes from the distal end of the control tube.
  • system further comprises at least one additional control wire connected to the distal end of the guidewire.
  • the system comprises a slide wire having a first end connected to the distal end of the guidewire and a second end formed having a loop through which the guidewire is slidably threaded, and wherein the control wire is connected to the slidewire loop.
  • a system comprising: a control tube having distal and proximal ends and dimensioned so that with the proximal end outside a body the control tube may be inserted into the body to position the distal end inside the body; a flexible guidewire having a distal end characterized by elasticity that varies as a function of distance from the distal end that is pushable through the control tube to protrude the distal end outside the distal end of the control tube; and a control wire connected to the guidewire distal end and control tube distal end.
  • a guidewire system comprising: a hollow flexible guidewire having a proximal end, a distal end, and an aperture towards its distal end; a control wire slidable within the guidewire from its proximal end to the aperture, the control wire configured to exit the guidewire at the aperture and to enter the guidewire at its distal end.
  • the guidewire system further comprising a connection point within the guidewire wherein the control wire and the guidewire are connected at the connection point.
  • the guidewire system further comprises a control tube configured to comprise the guidewire within it and to allow for slidable motion of the guidewire.
  • a guidewire system wherein the guidewire has a cross sectional diameter of about 0.4-0.9 mm.
  • the control wire has a cross sectional diameter of about 0.04-0.4 mm.
  • the control tube has an inner cross sectional diameter of about 0.5-0.7 mm and an outer diameter of about 0.9 mm.
  • a guidewire system configured to bend to form a loop.
  • the guidewire further comprising multiple regions of increased flexibility.
  • the length of one flexible region is different than the length of another flexible region.
  • the loop is configured to lodge the guidewire in the apex of a human left ventricle.
  • the loop is configured to have a short axis of about 10-60 mm and a long axis of about 20-100 mm.
  • the guidewire further comprises a region of increased rigidity located distally from a region of increased flexibility.
  • a method for placement of a guidewire in a patient comprising: introducing a guidewire system into a patient; bending the guidewire to form a loop configured to snugly fit in a terminus of a lumen of a patient; and lodging the loop in a terminus of a lumen of the patient.
  • the method further comprises adjusting the position of the guidewire to a position suitable for performing a procedure in the patient.
  • the method further comprises adjusting the position of the guidewire comprises pulling a control wire in the proximal direction, thereby adjusting the position of the guidewire relative to the lumen of the patient.
  • the terminus of a lumen of the patient is the apex of the patient's left ventricle.
  • pulling a control wire in the proximal direction changes the orientation of the guidewire crossing a valve to an orientation which is normal to the plane formed by the valve of the patient.
  • pulling a control wire in the proximal direction moves the guidewire to a position which is in the center of the aortic valve of the patient.
  • the method further comprises perfoming a diagnostic or medical procedure on the patient.
  • the method further comprises collapsing the loop formed by the guidewire.
  • the method further comprises removing the guidewire system from the patient.
  • the method further comprises removing the guidewire system from the patient using a catheter.
  • each of the verbs, "comprise,” “include” and “have,” and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

La présente invention concerne un système de fil guide à formation de boucle. Selon des modes de réalisation de la présente invention, un système de fil guide à formation de boucle peut comprendre un fil guide qui comporte au moins une zone de flexibilité augmentée, un tube de commande extérieur au fil guide, et un fil de commande qui possède deux extrémités, l'extrémité distale étant raccordée à l'extrémité distale d'un fil guide et l'extrémité proximale étant conçue pour être située à l'extérieur du patient. Le mouvement du fil de commande dans la direction proximale par rapport au fil guide peut fléchir une région de flexibilité augmentée d'un fil guide pour former une boucle de forme circulaire ou ovale qui peut alors être logée de manière sûre dans une lumière d'un animal par avance distale du fil de commande et du fil guide.
PCT/IB2014/064520 2013-09-16 2014-09-15 Système de fil guide à formation de boucle commandable Ceased WO2015036979A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361878058P 2013-09-16 2013-09-16
US61/878,058 2013-09-16

Publications (2)

Publication Number Publication Date
WO2015036979A2 true WO2015036979A2 (fr) 2015-03-19
WO2015036979A3 WO2015036979A3 (fr) 2015-06-11

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Application Number Title Priority Date Filing Date
PCT/IB2014/064520 Ceased WO2015036979A2 (fr) 2013-09-16 2014-09-15 Système de fil guide à formation de boucle commandable

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WO (1) WO2015036979A2 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5365943A (en) * 1993-03-12 1994-11-22 C. R. Bard, Inc. Anatomically matched steerable PTCA guidewire
CA2191619C (fr) * 1995-12-04 2002-03-05 David Kupiecki Cable de catheter medical en nickel-titane, a surface glissante
US6379319B1 (en) * 1996-10-11 2002-04-30 Transvascular, Inc. Systems and methods for directing and snaring guidewires
GB0307715D0 (en) * 2003-04-03 2003-05-07 Ethicon Endo Surgery Inc Guide wire structure for insertion into an internal space
US11246653B2 (en) * 2010-12-07 2022-02-15 Boaz Avitall Catheter systems for cardiac arrhythmia ablation

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