MXPA97009900A - Endovascular measurement device and means of loading and display - Google Patents

Abstract

An apparatus and method for measuring the desired length of a prosthetic device which is implanted in a body cavity of a patient is described, the apparatus generally includes a helically wound fastener formed of an elastically deformable material, a plunger that is connected to the proximal end of the fixator, a cap that slides over the plunger and fixator when the plunger and cover are used to removably insert and unfold the fixator in the body cavity, and a scale to measure an indication of the length of the fixator once deployed removably in the body cavity the proximal movement of the cover to partially deploy the fixator causes a length to be indicated on the scale, according to a method of the invention, the helically wound fastener of the apparatus is partially positioned and deployed within the body cavity by means of the use of the plunger and the cover of the appliance, once the fixator has With the bridge of the body cavity, the scale of the apparatus is used to determine the length of the deployed fixator, then the apparatus is removed from the body cavity and a fixator similar to the fixative of the apparatus is cut to the indicated length on the scale In a second embodiment of the apparatus and method, the fixator of the measuring device is substantially non-porous to allow occlusion of lateral vessels extending from the body cavity, then the patient is monitored to analyze the damaging effects that result from the occlusi

Description

ENDOVASCULAR MEASUREMENT DEVICE AND MEANS OF LOADING AND DEPLOYMENT FIELD OF THE INVENTION This invention relates generally to a measuring and testing apparatus for determining the size of a fixative in a body vessel and for determining the effect of the fixative on the surrounding tissue and organs. More particularly, this invention is given to an apparatus and method for measuring the length of a tubular braided fixer needed for use in a blood vessel, and to apparatus and methods for loading and deploying the fixator. The invention also relates to methods for determining whether a fixator, when deployed, can block important connecting vessels, and whether such blocking could be detrimental to the patient.

BACKGROUND OF THE INVENTION Transluminal prostheses are well known in medical techniques for implantation in blood vessels, bile ducts or other similar organs of the living body. These prostheses are commonly known as fixators and are used to maintain, open or dilate tubular structures or to support tubular structures that are being annealed. When biocornpatible materials are used as a cover or liner for the fixative, the prostheses are referred to as fixative graft or endoluminal graft. If used specifically in blood vessels, the fixator graft is known as an endovascular graft. A fastener can be introduced into the body by stretching it longitudinally or by compressing it radially until its diameter is sufficiently reduced so that it can be fed into a catheter. The fixator is released through the catheter to the deployment site and then released from the catheter, after which it self-expands. The shrinkage ratio is iramiento and the radial pressure of the fixators can usually be determined from basic braiding equations. A full technical discussion of braiding equations and mechanical properties of doβ fixatives is found in Jedweb, M.R. and Clerc, C.O., "A Expanding Netallic Stent - theory and Expe- pment" Journal of Applied Biomatepals: Vol. 4, pp. 77-85 (1993). In light of the above, it is evident that a fixator must possess certain elastic and compression qualities. A typical state of the prior art fixer, such as that described in US Pat. No. 4,655,771 for Uallsten or UK Patent 1,205,743 for Di cott and Uallßten, is shown herein in Figures 1, 2, and 2a of the prior art. Didcott and Uallsten describe a tubular body fixer 10 composed of wire elements 12, each of which extends in an elicoidal configuration with a center line 14 of the fixator 10 or a common axis. Half of the elements 12 are indented in one direction while the other half are dented in an opposite direction. With this configuration, the diameter of the fixator can be changed by axial movement of the ends 9, 11 of the fixator. Typically, the cross members form a braid-like configuration and are arranged so that the diameter of the fastener 10 expands normally as shown in Figures 1 and 1 a. The diameter can be contracted by pulling the ends 9, 11 of the fastener 10 away from each other as shown by the arrows 16, 18 in Figure 2. When the ends of the body are released, the diameter of the fastener 10 self-expands and drags away. the ends 9, 11 of the closer closer to each other. The fact that the fasteners undergo different changes in size from their compressed form to their non-compressed form, causes complications in their placement. The placement of a fixator that has any degree of elongation and radial force or compression result is very difficult for different reasons. First, the fixator, depending on its angle of inclination, may have to be pushed out of the catheter for a large distance. This can be extremely difficult in view of the increased friction forces and different bent sections found in the catheter as it traverses a sinuous path. Secondly, the fixer can be reversibly shrunk significantly in length as its diameter expands, thereby making it difficult to place it exactly in a vessel. Instead, a thrombus plate or other protrusions or inclusions in the lumen of the blood vessel may alter the diameter of the fixator which consequently alters the length of the fixator. The importance of extr-ema accuracy in the placement of an endovascular graft (EVG) will be appreciated by those skilled in the art. For example, in aneurysm vessel disease, such as that found in the abdominal aorta where the distance between the renal arteries and the aneurysm is very short (less than 3 crn.), The poor placement of an EVC through the arteries Renal or sun rays in the aneurysm can be fatal. Proper fixation of the fixator becomes impossible where the fixator is too long or too short for the body cavity in which it is to be deployed. To be effective, the dimensions of a vessel must be known very well and the fixer must be designed to match the vessel's specifications. However, different difficulties arise when trying to determine the appropriate fixator length for any particular cavity. One of these problems, present specifically when the self-expandable fixator design as it is written by Uallsten and Didcott, is that it is often difficult to predict exactly at what length the fixator should be cut to fit it properly within a particular blood vessel. For example, when an EVG is deployed in an aortic aneurysm, the distant end of the fixator may receive in the aneurysm area if the fixator is cut other short in length, thus not sealing the aneurysm and causing potential problems such as the rupture of the aneurysm. On the other hand, if the EVG is cut too long, the distant end of the EVG may extend into one of the iliac arteries leading to coagulation of the iliac artery with ralateral contusion. Also, if it is deployed in a vessel with multiple branching, an EVG that is too Long may inadvertently cover an arterial ramp, thereby occluding the branch and killing the organ that is intended to be nourished with starvation. It is now known to approximate the deployment length of an EVG fixator using different angiographic techniques (x-ray examinations of blood or lymphatic vessels after the injection of a radiopaque substance). In particular, this is done by injecting radiopaque dye into a beaker and photographing the dye with an x-ray machine as it moves through the beaker. One drawback of this method, however, is that angiography usually produces only two-dimensional views of the vessels under examination, which is limited by the plane by which the x-rays become. As a result, angiograms often fail to reveal the presence of sinuous trajectories of the examined vessel, which may be in and out of the plane of the angiogram. In addition, the EVG can expand in the aneurysm area, depending on the fibrin (the end product of insoluble protein of blood coagulation, formed from fibrinogen by the action of troinbma in the presence of calcium ions) contained in the aneurysm. , and contracts the narrow areas of the aneuris, making it difficult to predict the size of the fixator needed. It is also known to use arithmetic cornput (CT) and srm-lays to show diameter, arterial from which the desired length of deployment of the fixative can be ex-apol. The prediction of fixator deployment length is based solely on portions of diameter, and also the predictability of fibrin content in an aneurysm, however, limit the accuracy of CT scans. Other novel methods for visualizing vessels include spiral CT scanning and intravascular ultrasound (IVUS). In addition to sharing some of the same disadvantages of CT angioscopy and scrutiny, spiral CT scan provides an image of the outside of the blood vessel only, and therefore fails to show the vessel's mtenor where plaques and thrombi accumulate and where the fixative is to be placed. IVUS does not visualize the compressibility of fibrin and does not provide a reading of vessel diameter and length. Another disadvantage shared by the apparatus mentioned above is that they only provide instantaneous views of the vessel, and therefore may not be representative of exactly the diameter of the vessel during systole or diastole of the vessel. Another problem encountered with fasteners, especially with coated fasteners (EVG deployment) is that branching arteries are often occluded. For example, when an aortic aneurysm is corrected, an EVG is deployed between the neck of the proximal portion of the .neurysm below the renal to the bifurcation, or in the case of a bifurcated EVG, to the iliac arteries or more As a result, the EVG can occlude arteries such as the lumbar arteries, intercostal arteries and even the myocardial artery. In general, the occlusion of these arteries is not harmful to the patient since the senile and the spinal cord are fed by other collateral arteries. However, in a small number of patients, blockage of these arteries may result in paraplegia.

BRIEF DESCRIPTION OF THE INVENTION Therefore, an object of the invention is to provide an apparatus and method for measuring the length of an endovascular fixator or graft in a body vessel that provides accurate results. Also, an object of the invention is to provide an apparatus and method for measuring the length of an endovascular fixator or graft in a body vessel that is easy to use. Another object of the invention is to provide a method for temporarily blocking a branch of a body vessel and determining whether its blocking is harmful to the patient. An additional object of l a. invention is to provide an apparatus and method for measuring the length of a fixator or endovascular graft on a body vessel including a fixator made of elastically defnable material. Another object of the invention is to provide an apparatus and method for measuring the length of endovascular fixator or graft in a body vessel including a plunger and a cover for introducing and placing a fixator in a body vessel. A further object of the invention is to provide an apparatus for temporarily blocking a branching vessel wherein the apparatus includes a fastener made of an elastically deformable material that is coated with another elastically openable material that is capable of blocking a vessel from rarni i cacion. A further object of the invention is to provide an apparatus and method for measuring the length of endovascular fixator or graft in a body vessel that includes a calibrated scale. Another object of the invention is to provide an apparatus and method for measuring the length of an endovascular fixator or graft in a body vessel including a hollow catheter. A further object of the invention is to provide an apparatus and method for loading and deploying a length of endovascular fixator or graft that was measured according to the methods of the invention. According to the invention, an apparatus for measuring the desired length of a prosthetic device to be implanted in a predetermined body cavity of a patient generally includes a convoluted fixator formed by an elastically deformable material with or without a coating. , a plunger and cover for inserting the fixator into the body cavity and then releasing the fixative into the body cavity, and a measuring device for measuring an indication of the length of the fixator once deployed in the body cavity. The apparatus can be constructed with a catheter having a Lumen that accommodates a guidewire, thereby facilitating the guidance of the apparatus toward the body cavity, and with a dilating tip to facilitate manipulation of the catheter through the vasculature. In the preferred embodiment of the invention, the proximal end of the fastener is attached to the distal end of the plunger, the proximal end of the plunger is marked with a scale which is proportionally calibrated to the length of the fastener when in the compressed state, and the cover It is a good choice over the plunger. In this way, the movement of the cover in relation to the plunger deploys the fixer of the cover so that the fixator is free to expand in the vessel in which it is unfolding removably. The amount of movement of the cover in relation to the plunger can be measured on the scale. The reading on the calibrated scale represents the "rest" or completely uncompressed length of the fixator that is deployed by the cover and the plunger. Other preferred aspects of the invention include a cover for < err or stop the plunger at the proximal end of the cover that contains a screw cap and a compressible ring, and a plunger to close the catheter-at a proximal end of the plunger that also includes a screw cap and a ring or compressible . The screw hood and the compressible ring of the closure of the plunger cover are used to prevent unintentional movement of the cover in relation to the plunger.This also serves as a hemostasis valve during a surgical procedure. The screw cap and the compressible ring of the plunger closure to the catheter serves as an additional hernosetasis valve. If desired, a radiopaque means may be dispensed at the distal end of the hollow cat ter to allow the user to monitor the advance of the apparatus. In accordance with the objects of the invention, a method of measuring the desired length of a prosthetic device that is implanted in a body cavity of a patient using the measuring apparatus of the invention is provided. In accordance with the method of the invention, the elastically wound fastener of the apparatus is placed and deployed within the cavity of the body by means of positioning the apparatus. Once enough fixer length is deployed within the body cavity to encompass the desired length, the device's measuring device is used to determine the length at which the fixator should be cut. Then the apparatus is removed from the body cavity, and the fixative "read apparatus, or an equivalent fixator is cut to the measured length. In the preferred method of the invention, a guidewire is first manipulated through the body cavity where the fixative is deployed-until it reaches a point slightly beyond the deployment site. The cover of the apparatus is then fully extended by the fastener of the apparatus so that the fastener is compressed completely inside the cover. Then, the device is screwed along the guidewire by the hollow inner catheter of the apparatus until it is properly placed inside the body cavity. The user can regroup the advancement of the compressed fixator by using a fluoroscopic and radiopaque means that is transported and disseminated throughout the apparatus as it travels through the patient. In addition, the catheter and fixator alone are preferably radiopaque, thereby further assisting visualization under fluoroscopy. Once in position, the cover of the apparatus is retracted while keeping the piston stationary. The portion of the compressed fixator that is not covered by the cover is deployed within the body cavity by expanding radially and decreasing in length. The 1? Retraction of the cover continues until the user determines ediante? 1 uoroscopy that the area of the body cavity by bridging through the fixative, this is complemented by a bridge. At that point, that is, once the appropriate length of the fastener has been displayed, the position of the top of the cover in relation to the scale is read. Since the scale is calibrated, the values obtained will correspond directly to the length of the non-compressed fixator required to support the body cavity. After the measurement is completed, the cover is extended by the fixative, which is then repaired once for easy removal from the body cavity. A separate fixator is then prepared to the indicated length, and may be deployed in the body cavity by any means known in the art. Alternatively, the fixator used to measure the cavity can be used by cutting it off the measuring device at the indicated length and placing it in the body cavity accordingly. In accordance with other aspects of the invention, a removable bell is secured over the proximal end of the inner catheter, and the plunger-to-catheter closure is made removable. Using this arrangement, the length of the fixator is measured as outlined above. Once the measurement is read, the measuring device is completely removed from the body, the next removable hood is removed, the removable piston to inner catheter closure is removed, and L3 the distal end of the catheter is pulled out and the catheter is removed from the hollow plunger. The plunger connected to the fixative is then pulled anally until the fixer is removed from the cover. The fastener is then marked from its distal end to the required length, and the proximal end of the plunger still attached to the fastener is inserted into the plunger cover until the proximal end of the plunger protrudes from the distal end of the cover. The proximal end of the plunger is pulled hard from the distal end of the cover until the fastener is pulled to the deck triads and out the far end of the deck to the mark. Then, the fixative is cut close to the mark so that the fixative on the cover is of the desired size, and the plunger containing the other end of the fixer can be discarded; or alternatively, the remaining portion of the fixator-can be separated from the plunger by which the plunger can be reused. With the fixator loaded, the introducer system is preferably re-threaded with the removable bell, the removable plunger closure with catheter, and a new or reused plunger. Additional objects and advantages of the invention will be apparent to the person skilled in the art by reference to the detailed description taken in conjunction with the Figures provided.

BRIEF DESCRIPTION OF THE DRAWING Figure 1 is a side elevational view of a prior art fastener expanded in an unstretched position. Figure 1 is a cross-sectional view along the line 1A-1A of Figure 1. Figure 2 is a side elevational view detached of a prior art stretched and contracted fixator; FIG. A is a cross-sectional view along the line 2A-2A of Figure 2. Figure 3 is a transparent side view detached from the endovascular measurement apparatus of the invention with its cover retracted. Figure 4 is a transparent side view detached from the endovascular measurement apparatus of the invention when partially inserted into a body cavity and with its cover fully extended. Figure 5 is a later-to-transparent view detached from the endovascular measurement apparatus of the invention when it is fully inserted into a body cavity and with its cover fully extended. Figure 6 is a transparent side view detached from the apparatus of endovascular measurement of the invention that deploys the fixator within a body cavity so that the fixator partially bridges the body cavity. Figure 7 is a detached transparent side view of the endovascular measurement apparatus of the invention which deploys the fixator within a body cavity of the nose that the fixator completely bridges the body cavity. Figure 8 is a view similar to Figure 7 illustrating the measuring apparatus with a non-porous fixer deployed in a body cavity having branching vessels; Figure 9 is an elongated view similar to Figure 3 of a removable proximal bell used in conjunction with a method of the invention to deploy the measured fastener; and Figure LO is an elongated view similar to Figure 3 of a removable hernosetasis valve used in conjunction with a method of the invention for deploying the measured fixator.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY Turning now to Figure 3, the endovascular measurement apparatus 100 of the invention broadly includes a hollow plunger 102, a wire fixator 104, a hollow cover 106, and a hollow interior catheter 108 attached to a bell 109. The plunger 102 has a proximal end 110 with a first closing hemostasis valve 112 and a distal end 117 which is IB fixed to the proximal end 118 of the fixator 104. The hernostase valve 112 includes a ring 0 113, and a closure cap L14. Fi lumen (not shown) of the hollow plunger L02 is dimensioned so that it can freely slide over the body of the hollow inner catheter 108. The hollow inner catheter 1 (18) serves as a guide for a guide wire 144 and as a latch. to retain a soft flexible hollow dilator tip 148 in position at the distal end 146 of the catheter 108. The tip 140 can be adjusted relative to the distal end 116 of the plunger 102 by sliding the internal catheter 108 into the plunger 102. Once the tip 148 is adjusted to accommodate the compressed fi lter 104, the inner catheter 108 is closed in position by tightening the cap 114 on a thread portion 117 of the first closure hemostatic valve 112. The layer 114 is effectively a closure mechanism. which comprises the ring 0 113, thereby fixing or closing the plunger 112 in relation to the inner catheter 108 and the tip 148. The body 120 of the plunger 102 contains a calibrated scale 122 having, p or example, 50 major divisions 124 separated into calibrated intervals. The scale 122 is calibrated to adjust the longitudinal shrinkage and diameter expansion experienced by the particular fixator 104 when decompressed; that is, the ratio of the length of the fixer when it is on the cover to the length of the fixer when it is not compressed. The proximal end 1.8 of the wire fixer 104 ße 1? f-i ja to the distal end 1 L6 of plunger 102 by any convenient means such as heat fusion, insert molding, or adhesion with epoxy resin. The body 128 of the fixator and wire 104 when not compressed has a greater diameter r. The plunger 102 and the cover 106 are opened. The distal end portion 130 of the cover 106 is open, and the cover LU6 has a diameter Slightly larger than that of the body 122 of the plunger 102, which can be moved to along the body dl ernboLo. Cover 106 LU is furthermore movable on the fixator 104 due to flexible and deformable features of the fixator 104. It will be appreciated that when the cover 106 is placed over the fixator and aLambre 104, the fixer 104 contracts and lengthens in a manner similar to that discussed in FIG. the background of the invention and 15 shown at 132. The proximal end 131 of the cover 106 is attached to a second henosease valve 133 which is preferably provided with external threads 135. A second screw cap 138 containing a second compressible ring 0 140 is 20 coiled copper the proximal end of a second sealing hernose valve 133. The second screw cap 138 matches the threads 135 of the second shutoff valve 133 to reversibly tighten the cover 106 to the plunger 102. The 0 ring is used to prevent inadvertent sliding of the cover 106 in relation to the plunger 102 acting as a friction closure mechanism, and to serve as a hernostasis valve during surgical intervention procedures. Pulling the first shutoff valve 112 away from the second shut-off valve 133 'or pushing the cover 106 in relation to the plunger 102), the fastener-on the hoist L04 can be pulled towards the cover 106 and compressed. Rather, by pushing the first shut-off valve 112 towards the second shut-off valve 133 (or pulling the cover 106 relative to the plunger L02), the distal end 126 of the wire fastener 104 can be released and expanded toward its configuration. uncompressed relaxed towards (and if) being restricted by the blood vessel in which it is deploying. It will be appreciated that the second lock valve 133 can be positioned and closed anywhere along the body 120 of the plunger 102., thus providing the user with a means to control the length of the fastener 104 to be deployed. By reading the scale 122 at the location of the nearest end 142 of the second shut-off valve 133, can it determine the length of fixer required for deployment within the body cavity 20? at any given time. In particular, since the scale 122 is preferably calibrated to the ratio of the length of the fastener 104 when compressed in the cover 106 to the length of the fastener 104 in its uncompressed state, the reading provided on the calibrated scale will inform the practitioner about the length of non-compressed fixer required to make any cavity in any path, regardless of the state in which the fixer assumes when deployed in the cavity. Referring still to Figure 3, it is observed that both the first and the second closing hernosetasis valve 112, 133, are provided, preferably with flood lines L15, 137. Lines 116 and 137 allow the spaces between the concentric hollow cover 106, hollow catheter 108 and hollow plunger 102 are flooded with hepatic saline during the insertion procedure. It is also seen that the hollow catheter L08 extends from the proximal bell 109 after the open distant extrusion 126 of the fixator 104. The catheter 108 has an internal lumen (not shown) di-injected to follow a guidewire 144 toward the body cavity 202 (see Figure 4) of a patient. The distal end 146 of the catheter 108 is coupled to the hollow dilator tip 148. The hollow catheter 108 and the dilator tip 148 are capable of transporting a radiopaque contrast medium (not shown) used for fluoroscopic visibility. The plunger 102 and the cover 106 of the apparatus 100 can be made of any durable biocompatible material such as nylon, polyurethane, Teflon®, polyester, PVC, polyethylene, polypropylene, etc., or different combinations of the above, with or without radiopaque fillings such as as barium sulfate or bismuth subearbonate. The dilator tip 148 can be formed of the same materials as the plunger 102 and the cover 106, but is preferably formed of a softer material such as Shore 80A, polyure + ano or Pebax nylon with a radiopaque filler or a marking band. -ad? o? The measuring apparatus 100 of the invention can be made deεsable or reusable. The lumen (not shown) of the inner catheter-108 or the annular space L50 between the cover 106 and the plunger 102 can be used to inject opaque radio contrast medium into the vessel to assist in the placement of the 100th accessory. as discussed above. The fixer material 104 may be the same material and geometry similar to that used in an EVG, or may be a radiopaque material such as tungsten, stainless steel, gold and the like. Apparatus 100 can be used in virtually any body cavity area such as the urethra, esophagus, bile duct, blood vessels, etc., or in any surgically made conduit or shunt such as those made in the liver during transhepatic portosystemic shunt procedures. transjugular. Referring now to Figures 4-7, apparatus 100 of the invention is seen with reference to the method of the invention. In accordance with the method of the invention, the measuring apparatus 100 of the invention is placed micially in its fully extended position axially (see Figure 4), with the cover 106 covering the entire length of the wire fixer 104 which is Completely compressed. In this configuration, the second shut-off valve 133 of the cover 106 is at its distance far from the first shut-off valve 112 of the plunger 102, and is aligned with the scale 122 that the closest end 142 of the stopper coincides with The "0" mark 204 on the scale 122. The tip 148 is adjusted to accommodate it in the cover 106 by loosening the first shut-off valve 112 and pulling the inner hollow catheter 108 proximally so that the graduated proximal end 143 of the tip 148 fits into the cover 106 and the distal end 116 of the plunger 102 bears on the proximal end 118 of the ripper 104. The former remote paddle 206 of the guide wire 144 is located sufficiently after the body cavity 202 to allow the proper placement of the measuring apparatus 100. When the measuring apparatus is placed 100, the distant ends of the fixator 104 and the cover 106 should locate only slightly after the distant neck 208 of the body cavity 202 in which the fixer 100 is deployed (see Figure 5). This is done to compensate for the tendency of the fastener 104 to contract in length when going from its configuration compressed in the cover 106 to its deployed configuration in the vessel 202. It should be noted that the flexible hollow dilator tip 148 at the distal end 146 of the catheter 108 is radiopaque. In this way, a user can monitor the progress and placement of the measuring apparatus 100 by means of a fluoroscope (not shown). Once the measuring apparatus 100 is properly positioned within the body cavity 202 (as in Figure 5), the cover 106 is slowly retracted (see Figure 6) by first loosening the shutter 138 on the second shut-off valve. 133 and thereafter, while holding the stationary plunger 102, pulling the cover 106 toward it attracts. As the cover retracts, the distal end 126 of the fastener 104 is released and expanded back to its uncompressed configuration until it engages the distal neck 208 of the cavity 202. It will be appreciated that as the distal end 126 of the fastener 104 has a non-compressed diameter at rest greater than the diameter of the distal neck 208 of the body cavity 202, the distal end 126 of the fixator exerts pressure on the distal neck 208 when deployed, causing the distal end 126 of the fixator-104 close in place. As mentioned before, the total length of the fixator 104 decreases as it goes from its compressed configuration to its expanded configuration compressed. In this way, it is important that the user position of the distal end 126 of the fastener 104 sufficiently pass the distal neck 208 of the body cavity 202 to compensate for this shrinkage. However, it will be noted that if the practitioner discovers, after the cover 106 has been retracted, that the distal end 126 of the fixator 104 is not sufficiently positioned within the distal neck 208 of the body cavity 202, the practitioner only needs re-extending the cover 106 completely over the fixator 104 and repeating the previous steps of placement. As indicated in Figure 7, the cover 106 is retracted until the user determines, by fluoroscopy, that the fixator 104 is deployed sufficiently to bridge the length of the body cavity 202. As shown in Figure 7 , the length of the fixator 104 rotatably deployed must be substantially larger than the length of the body cavity 202. In this manner, the proximal end 718 of the length of the deployed fixator 104 and the distal end 126 of the fixator are Place respectively within the proximal and distant necks 210, 208, of the body cavity 202. Once the desired length of the fastener 104 is retractably deployed, the closest end 142 of the second shut-off valve 133 is used as an indicator on scale 122 of plunger 102. As discussed earlier, scale 12? Is it calibrated in a way that the indicated number 70? represents the uncompressed length of the fixer required to completely bridge the body cavity 202. In this particular case, the scale 122 indicates 27 inrn, meaning that a fixative having at rest a non-compressed length of 27 mrn must be used to make - bridge appropriately with body cavity 202, which can be, eg, 20 rnm long. Once the measurement is completed, the cover 106 is again extended over the fixator 104 (as in FIG. 5), thus compressing it again, and all of the measuring apparatus 100 is removed from the body cavity 202 and the patient. The fixator 104 can be released after the LOO cortome measurement step, for example with scissors, or a new fixative or fixative can be obtained (not shown) having the same properties and inclination angle. that the fixator 104 of the measuring device 100, and that has at rest a non-compressed length equal or proportional to the recorded measurement. In the previous example, a 27 mm fixator of the same diameter and geometry can be obtained in such a way. This fixative is then inserted into the body cavity 202 by deployment by any means known in the art. As the measurement method of the invention has already determined the proper length of the fixator, the user is left alone with the task of appropriately placing the fixator within the body cavity 202. Returning now to FIG. 8, it observes a second embodiment of the apparatus 300 of the invention. In this embodiment, the fixator 304 of the measuring apparatus 300 is coated with a microporous or non-porous elastomeric membrane. The apparatus 300 has particular advantageous use when the body cavity 301 has several branch vains 302, 303, and a saccular aneurysm 308. With the measuring apparatus 300 deployed within the body cavity 301 as shown, they can be repeated. organs and tissues (not shown) fed by branching vessels 302, 303, to determine whether they are suffering from detrimental effects as a result of blockage of branching vessels 302, 303, caused by the non-porous fixer 304. For example, If Branching vessels 302, 303, represent arteries that nourish the spinal cord, the lower extremities of the patient can be analyzed and monitored to determine if blockage of these arteries causes paraplegia in the patient. If such determination is made, the coated fixer may be cut shortly in order not to block the branching vessels, or the process may be completely terminated. Similarly, when a bridge is established in an aortic aneurysm, the measurement device can be used with a coated fixator to determine if there is a counterflow, for example, a lumbar artery, to the aneurysm, which it is not occluded, it can lead to rupture of the aneurysm. If a counterflow is detected, intervention block of the Lumbar artery with an occlusion device may be required before applying the fixative in the aorta. In accordance with another aspect of the invention, in FIGS. 9 and 10, a removable bell and valve are shown to be capable of being used in conjunction with the methods for loading and deploying a fixator or fixator graft. In particular, in FIG. 9 a removable bell 310 is seen for use in the endovascular measurement apparatus 100 of FIGS. 3-8 (in place of the bell 109), which has a cover 312 which is threaded onto the filaments 314. , a ring 0 316, a lumen 317, and a handle 318 having a luer lock 320 capable of being connected to a valve of the like or the like. The internal catheter 315 is fed through the lumen 317 of the detachable bell and closed in position by pressing the lid 312 on the filaments 314, thereby compressing the ring 0 316. Similarly, the flexible hernosetasis valve 410 of Figure 10 is intended to replace the valve closure L12 of Figures 3-8. The removable henostasis valve 410 includes a body portion 4L2 having proximal filaments 414 and distant filaments 416, distant and proximal caps 418, 420, a lumen 422, distant and nearby aniLlos 0 424, 426, and a flood gate 430. The catheter 108 and the plunger 120 pass through the lumen 422, and when in position, the distal cap 420 can be pressed onto the distant filaments 416 to compress the distal ring 042 and close the valve on the plunger 120. Similarly, the proximal cap 418 may be tightened on the proximal filaments 414 to compress the proximal ring 0 426 to close over the inner catheter 108. The flood gate 430 may be used to allow flooding of the annular space between the embolus 120 and internal catheter 108 with, v.gr-.saline solution hepap ni zada. With the removable hood 310 and closure 410 provided as in Figures 9 and 10, the method of measuring a desired length of fixer as described above with reference to Figures 3-8 can be carried out. However, in accordance with another aspect of the invention, after the measurement, the apparatus provided can be used for loading and deploying the fixative-fixed fixator. In particular, after the desired length of the fixator has been measured, the entire measuring apparatus is removed fthe patient's body. Preferably, all lumens of the apparatus are then flooded with hepapnicized saline. The removable hood 310 (FIG. 9) is then peeled off and removed, and the peelable closure 410 is peeled off and removed. With the hood 3L0 and closure 410 removed, the tip of the Latadora 148 is grasped and pulled away fit, so that the internal catheter 108 is completely removed fthe hollow plunger 120. Afterwards, the proximal end of the plunger 120 is pulled out of the proximal end. It is necessary to pull the fixator 104 fone side to the other and completely out of the cover 106. Using a sterile waterproof felt tip pen, or the like, or any other convenient mechanism, the fixing fixator or graft 104 is marked to the desired length fits distant end 126 (e.g., 27 rnrn fthe distant end of the fixator). With the marked fixator, the proximal end of the plunger 102, still connected to the fixator 104, is inserted into the cover, and through the plunger closure 133 the proximal end 120 of the plunger protrudes fthe distal end of the cover 106.; that is, the plunger is inserted backwards through the cover. The proximal end of the plunger protruding from the distal end of the cover is then pulled to pull the fixator or locking graft 104 toward the cover and away from the distal end of the cover at 20 brand. Then, the fixer 104 is cut at or close to the mark so that the remaining fixer (with the mark) with the plunger can be discarded and the fixer on the cover can be properly loaded. With the cover loaded, the introducer system is reassembled by inserting the catheter 108 through the cover and fixator, if desired, providing a plunger to push out the fixator or graft fixer L04 when properly located, and, if it is desired, joining again the bell 31 ü to the catheter, and the closure 41 ü to the plunger and the catheter. It will be appreciated that the plunger used with the loaded cover may be a new plunger used to deploy the fixator 104, or the remaining portion of the fixator used in the initial filling with the excess fixator-removed from the plunger. The loading and unfolding method of the invention has several advantages as indicated above. It will be appreciated that, since the fastener is loaded by pulling the fastener with the plunger, there is less chance that the fastener threads will scrape and puncture the cover pair. In addition, the tunnels usually required to load the fixer are eliminated, and the fixer loading operation is simple. In addition, the fixing fixator or graft used is the same unit that was used as the measuring device, thereby making the system expensive. Various embodiments of a tubular braided fastener and a manufacturing method of the inventive fastener have been described and illustrated herein. Although particular embodiments of the invention have been described, the invention is not considered to be limited thereto, since the invention is considered to be as broad in scope as the technique allows and the specification to be so read. In this way, although particular arrangements of fixer have been described for use with the apparatus of the invention, it will be appreciated that other designs may also work. For example, although a fastener has been described as having a homogeneous angle of inclination, a fastener with a different end body and tip angle can also be used, as described in the co-pending US patent application. S.N. 08 / 388,612, or hyperbola fixators of continuous variation can be used. Furthermore, although a particular mechanism has been described for adjusting and closing the cover in relation to the plunger and a similar method for closing the plunger in relation to the internal catheter, it will be understood that other mechanisms or no mechanism may also be used. Also, although a particular type of scale was described, it will be recognized that any other suitable scale can be used. For example, although a metric scale was described, an English system scale or any other scale of measurement system may also be used. In addition, although a printed scale was described along the plunger body, instead, the scale may include electronic measurement means coupled to an LCD reading marker. In addition, although he described that the scale has a particular calibration, any other calibration can be used. For example, although the scale was calibrated to calculate the contraction experienced by the fixator when it is in an uncompressed configuration, the scale can be calibrated from any other configuration or it may not be calibrated. When it is not calibrated, the practitioner can perform the math calculations necessary to determine the length of the non-compressed fixer to be used, or it can cut a fixative in its compressed state in a cover the same way as the cover of the apparatus. In fact, if desired, no scale or calibration is necessarily required on the plunger, since the plunger can be marked by the practitioner during use and measured later. Although this measuring apparatus has been described for use with a self-expanding fixator of Ualisten or Didcott configuration, it will be appreciated that the measuring apparatus can be calibrated for use with other devices such as Palrnaz or Gianturco balloon expandable fixators and the like. The device can also be used to acquire accurate measurements of body cavities for data collection and subsequent use for other procedures such as bypass surgery, electrophysical rnapeo, endoscopic surgery, etc. In addition, although a particular configuration for the dilator tip was described, it will be appreciated that other configurations or no dilator tips may also be used. In addition, although a particular monitoring means was described-to be used with the apparatus, it will be understood that any monitoring means can be used similiarly. In particular, although fluoroscopy was described as monotherapy medium, other means such as fluoroscopy and CT scanning may also be used. Furthermore, although a particular method was described - of measuring the length of deployment of a fixator in a body cavity using the apparatus of the invention, it will be understood by the person skilled in the art that the details can be altered without changing the nature of the method. Therefore, it will be appreciated by the person skilled in the art that other modifications may still be made to the apparatus and method provided with the invention, without deviating from its spirit and scope as claimed.

Claims (9)

NOVELTY OF THE INVENTION CLAIMS

1. An apparatus for measuring an indicated length of a prosthetic device to be implanted in a cavity of a living body, comprising: a) a fixator formed of a material that is deformable only; b) placing fixedly attached means to said fixator to insert and partially unfold said fixator in the body cavity without releasing said fastener from said positioning means, and to remove said fixator from the body cavity once partially deployed; c) measuring means for measuring an indication of a length of said fixator that was partially deployed in the body cavity, said measuring means being coupled to any of said helically wound fastener and said positioning means.

2. An apparatus according to claim 1, characterized in that said fixator is a helically wound fastener.

3. An apparatus according to claim 1, characterized in that said fixator has a coating that is substantially or substantially non-porous.

4. An apparatus according to claim 1, characterized in that said fastener has a distal end and a proximal end, said positioning means comprises a plunger having a distal end or said proximal end of said fastener, and an adjustable cover deflectably around said plunger and said plunger. 5.- An apparition according to the renouncement 4, characterized in that said measuring means comprises a scale. 6. An apparatus according to claim 4, characterized in that said measuring means comprises a calibrated scale. ? . - An apparatus in accordance with the claim 6, characterized in that said calibrated scale is calibrated by the ratio of a diameter of the fixer when the fixer is not compressed to a diameter of said fixer when said fixer is in said cover. 8. An apparatus according to claim 4, characterized in that said rail has a proximal end having a closing mechanism. 9. An apparatus according to claim 4, characterized in that said cover has a ring 0, which extends around said plunger. 10. An apparatus according to claim 4, characterized in that said apparatus further comprises guiding means for guiding said apparition inside the cavity of the body. 11. An apparatus according to claim 10, characterized in that said guide means include a hollow catheter extending from said proximal end of said plunger to said distal end of said helically wound clamp, said catheter having a lumen. Directed to fit around and be moveable around a guide thread. 12.- A part in accordance with the claim 11, further characterized in that it comprises monitoring means for monitoring the placement of said apparatus in the body cavity. 13. An apparatus in accordance with the claim 12, characterized in that said monitoring means comprises a dilating tip located at said distal end of said hollow catheter and contains a radiopaque medium. 14. An apparatus comprising: a) a fastener formed of an elastically deformable material and having a proximal and distant end; b) a plunger having a proximal end and a distal end, said distal end of said plunger being fixed to the proximal end of said fixator; c) an adjustable cover slidable about said plunger and said fixator, wherein the axial movement of said cover effects radial expansion and contraction of said fixator with said plunger being fixed to said fixator of said node that said fixator is not released from said fixator. plunger; and d) a hollow catheter extending from said proximal end of said plunger to said distal end of said fixator, said catheter having a lumen directed to fit about and be translatable around a guide wire. 15.- An apparatus in accordance with the claim 14, further characterized in that it comprises: o) measuring means for measuring an indication of a length of said fastener that is deploying in the body, said measuring means are coupled to one of the helically wound fastener, said plunger and said cover. 1 .- An apparatus according to claim 15, further characterized by comprising: f) a dilator tip coupled to a distal end of said hollow catheter. 17. An apparatus in accordance with the claim 15, further characterized in that it comprises: f) a first hernosetasis valve coupled to a proximal extrusion of said cover; and g) a second hernostase valve connected to a proximal end of said plunger. 18. An apparatus according to claim 15, characterized in that said second hernostasis valve is detachable from said proximal end of said plunger. 19. A device according to claim 18, characterized in that said catheter has a proximal bell that is removable from said catheter. 20. An apparatus in accordance with claim 15, characterized in that said measuring means comprises a scale calibrated on said plunger, said calibrated scale is calibrated by a ratio of a diameter of said fixator when said fixator is not compressed to a meter of said fixator when the fixator is in said cover. 21. - Apparatus according to claim 20, further characterized in that it comprises: f) a tip dLlatadora coupled to an extr-emo distant from said hollow catheter; g) a first herniated valve coupled to a proximal end of said cover; and h) a second sperm valve coupled to a proximal end of said plunger. 22. An apartment in accordance with the claim 21, characterized in that said second hernostasis valve is detachable from said proximal end of said plunger. 23. An apparatus in accordance with the claim 22, characterized in that said catheter has a proximal bell that is detachable from said catheter. 24. A method for measuring the desired length of a prosthetic device to be implanted in a body cavity of a patient using a measuring device having a fixator formed of an elastically deformable material, a means of positioning to insert and remodel said fixator removably in the body cavity, and a measuring means to obtain an indication of a length of said fixator that was deployed in the body, said method comprises: a) compressing the fixator of the apparatus so that the diameter of the fixator is smaller than the diameter of the body cavity; b) locating the compressed fixator within the body cavity; c) using the positioning means for deploying a first portion of the fixator in the body cavity in a manner that at least a portion of said first portion expands the diameter; d) obtain an indication of a length of the fixator that was deployed in the body cavity; and e) removing the fixative- and apparatus from the body cavity. 2

5. A method according to claim 24, characterized in that the fixator is wound helically. 26.- A method according to claim 24, characterized in that the fixator has a coating that is microporous or substantial.not porous, and the cavity of the body has one or more sideways edges that extend from the bottom. 27. A method according to claim 26, characterized in that it comprises: f) after using the positioning means to removably deploy at least a first portion of the fixator in the body cavity so that at least a portion of said first portion expands the diameter, monitoring the patient to determine how the occlusion affects the patient of one or more lateral vessels of the body cavity by the fixator-, 28. A method according to claim 25, further characterized by comprising: after obtaining an indication of a length of the fixator that was deployed in the body and before removing the fixator and the apparatus from the cavity of the body. body, capture all the fixative with the means of placement. 29. A method according to claim 25, further characterized in that it comprises: f) cutting the fastener to a length based on said indication obtained to obtain a cut fastener. 30. A method according to claim 29, further characterized in that it comprises: g) introducing the cut fastener into the cavity of the body. 31.- A method according to claim 25, further characterized in that it comprises: f) obtaining a fixative of sub-existent characteristics identical to the fixator that was unfolded removibly in the body cavity, the fixative of sub-substantially identical characteristics is of a related length with said indication obtained. 32. A method according to claim 31, further characterized in that it comprises: g) introducing said fixator of substantially identical characteristics in the body cavity. 33.- A method in accordance with the claim 29, further characterized in that it comprises: the measurement means of the apparatus on a calibrated scale, said obtaining an indication comprises observing the calibrated scale, and said cutting at a length is at the length indicated by the calibrated scale. 34.- A method of confinement with claim 31, characterized in that the measurement means of the apparatus is a calibrated scale, said obtaining of an indication comprises observing the calibrated scale, and said obtaining of a fixer of substantial characteristics. identical comprises obtaining a fixator of a length indicated by the calibrated scale. 35. A method of conformity with claim 25, characterized in that the placement means includes a cover and a plunger, with a distal end of the plunger attached to the fixator, and the plunger and the fixator are located in the cover, said method also comprises: f) removing the means of placement and the fixer of the cover; g) inserting the proximal end of the plunger first into the proximal end of the dome cover so that the plunger and the desired portion of the binder extend out of a distal end of the cover; and h) cutting the fastener of the distal end of the fastener-to a length based on said obtained indication, to obtain a cut fastener loaded in the cover. 36.- A method according to claim 35, further characterized in that it comprises: i) inserting said cover with said cut fastener into the body cavity; and j) pushing said cut fastener out of said cover in order to introduce said cut fastener into the body cavity. 37. A method of loading a fixator into a fixator introducer apparatus having a cover, comprising: a) obtaining a fixator attached to a plunger; b) inserting the plunger at the top of the cover until a first portion of the fastener is contained in the cover, and a second portion of the fastener is outside the cover; and c) cutting the substantial fixer adjacent to the cover and removing said second portion of the fixer with the plunger, said first portion of the fixer remaining loaded in the cover. SUMMARY OF THE INVENTION An appendix and method is decribed to measure the desired length of a prosthetic device that is implanted in a body cavity of a patient; the apparatus generally includes a wound clip which is formed of an elastically deformable material, a plunger that is connected to the proximal end of the fixator, a cover that slides over the plunger and fixator-when the plunger and cover are used to insert and releasably deploying the fixator in the body cavity, and a scale for measuring- an indication of the length of the fixator once deployed removably in the body cavity; the proxirnal movement of the cover to partially deploy the fixator causes a length to be indicated on the scale, according to a method of the invention, the helically wound fixator of the apparatus is placed and deployed partially within the body cavity by means of the use of the plunger and the cover of the apparatus; once the fixator bridges the body cavity, the scale of the apparatus is used to determine the length of the fixator-deployed; then, the apparatus is removed from the body cavity and a fixator similar to the fixative of the apparatus is cut to the indicated length on the scale; in a second embodiment of the apparatus and method, the fixator of the measuring apparatus is substantially non-porous to allow occlusion of lateral vessels extending from the body cavity; Then, the patient is monitored to analyze the harmful effects that result from the occlusion. EA / elt * fac * rnmm P97 / 1337F