US20170056223A1 - Strain Management in Stent Delivery System - Google Patents

Abstract

A delivery system for a medical implant and a method of delivering the medical implant. The delivery system includes an inner catheter and an outer catheter. The inner catheter includes a wire coil disposed between an inner tube and an outer tube, the wire coil having gaps between turns of the coil at a proximal and a distal region thereof. The outer catheter is disposed about the inner catheter. The system includes a flow path for liquid from a proximal end to a distal end thereof, the flow path including a radially extending portion through the gaps. The method includes inserting the delivery system into a body lumen, injecting visualizing fluid into the proximal end of the system, the visualizing fluid moving through the flow path and exiting the distal end of the system, and retracting the outer catheter to release the medical implant.

Description

PRIORITY
• This application is a division of U.S. patent application Ser. No. 10/555,228, filed Oct. 31, 2005, now U.S. Pat. No. 8,790,385, as a national stage application under 35 USC §371 of International Application No. PCT/EP2004/004974, filed May 10, 2004, claiming priority to United Kingdom Application No. GB 0310714.1, filed May 9, 2003, each of which is incorporated by reference into this application as if fully set forth herein.
BACKGROUND OF THE INVENTION
• This invention relates to medical devices and, more particularly, but not exclusively, to devices for performing minimally-invasive surgical procedures.
• When performing medical operations, it is of paramount importance that the surgery itself causes as little trauma to the patient as possible. For this reason, medical science is continually developing new and improved methods for treating patients and reducing the risk of severe consequences arising from the procedure itself In recent years, techniques such as keyhole surgery and endoluminal or transluminal treatments, which avoid the need for traumatic open surgery, have become common practice in many parts of the world. Benefits to the patient include reduced external scarring, minimal trauma during surgery, reduced risk of infection and shorter recovery periods. Correspondingly, there has been a demand for new and improved surgical equipment, capable of performing minimally invasively the functions required to successfully treat the numerous and varying medical conditions. As a result, there is ever-increasing pressure for individual instruments to combine an increasing range of functions, to be of smaller dimensions and to maintain or improve the accuracy and manipulability of the devices.
• In the specific field of transluminal or endoluminal surgery, one drive is towards reducing the diameter of devices to be inserted into and guided along a body lumen, in order to allow surgical procedures to be performed in narrow conduits such as blood vessels which are inaccessible to larger devices. At the same time, it is necessary to ensure that the devices can perform to a high level of accuracy and can be easily directed and controlled by the surgeon, particularly when they have to be guided through the tortuous passageways such as are defined by interconnecting blood vessels within the human body.
• Common procedures include the treatment of coronary diseases and deficiencies by the endoluminal implantation and deployment of stents or replacement valve structures at locations where the natural blood vessels have become defective, blocked or damaged. In such a procedure, a medical device is loaded onto or into a delivery catheter in a compressed or reduced-diameter configuration. The catheter is then inserted through an incision into a blood vessel, typically the femoral artery, and guided through the passageway of inter-connecting blood vessels to the site requiring treatment. The medical device then expands or is expanded within the passageway at the treatment site, where it remains. The delivery catheter is then retracted through the passageway and removed through the same incision.
• EP 0836447 B1 discloses a stent delivery system comprising an inner core, having a proximal end and a distal end, made from a wire coil; a stent concentrically arranged around the inner coil near the distal end; a sheath concentrically arranged around the inner coil extending from the proximal end to a distal end proximal of the stent; an outer sheath covering the stent; and means for retracting the outer sheath. When the delivery system has been inserted and guided to the correct location, the outer sheath is retracted, releasing the stent contained therein. During insertion of the catheter, the wire coil is flexible, allowing it to advance through the tortuous passageway defined by the inter-connecting blood vessels. During retraction of the outer sheath.
• EP 1181906 B1 discloses a similar stent delivery catheter, including a wire coil and further including a covering that fits over the coil to help resist buckling in bending and compression.
• There is associated with endoluminal surgical procedures the need to visualize the position of the catheter as it is advanced through the bodily lumen, and to ensure that the device is properly located prior to, during and after deployment. In order to visualize the position of the advanced distal end of the catheter, pulses of visualizing fluid are injected into the bodily lumen so that the catheter distal end can be seen using visualisation means, such as radioscopy or fluoroscopy. In order to transport the visualizing fluid, prior art devices either provide a separate lumen within the catheter, for transporting visualizing fluid from the proximal end to the distal end of the catheter, or visualizing fluid may be injected through a guide catheter, within which the delivery catheter is advanced. In the latter system, the catheter can be provided with a shaft that is narrow except at the distal end, where the medical device is held, so that a sufficient volume of visualizing fluid can flow within the guide catheter lumen around the shaft and is not restricted until it reaches the distal end. A continuing preoccupation for catheter designs is how to provide sufficient quantity of visualizing fluid from a proximal end to a distal end of the delivery catheter without requiring an increased diameter catheter and without restricting the flow past the delivery catheter.
• With the prior art devices, there is often a trade-off between the flexibility of the delivery catheter and the resistance of the delivery catheter to compressive forces during retraction of the sheath containing the medical device. One method of mitigating this difficulty has been to reduce the length of the sheath relative to that of the medical device, and thereby reduce the friction force resisting retraction of the sheath during deployment of the medical device. A pull wire within the catheter can be used for controlled retraction of the sheath once the catheter is correctly positioned. In some prior art devices, the outer sheath is braided or has wire reinforcement to prevent the sheath from lengthwise stretching, so that the sheath will retract when the actuating means is operated and not just become longitudinally stretched. This results in the sheath having increased thickness. Therefore, another problem is to provide a system with reduced overall diameter that is flexible and controllable, without losing compression-resistance in the inner coil, and without the sheath stretching during retraction and incorrectly deploying or failing to deploy the medical device.
BRIEF SUMMARY OF THE INVENTION
• In accordance with one aspect of the invention there is provided a percutaneous, transluminal system with a distal end for inserting into a body and a proximal end to remain outside the body, and comprising an inner tube which runs the length of the system and has a distal end and a proximal end; a wire coil disposed around at least a portion of the inner tube, having a distal end, a proximal end, a distal region, an intermediate region and a proximal region; and an outer tube, having a distal end and a proximal end, disposed around at least a portion of the wire coil, characterized by: the wire coil having a closed-coil structure in the intermediate region and an open-coil structure in at least one of the distal region and the proximal region; and by a flow path for liquid from the proximal to the distal end of the system which includes a radially extending portion through said open-coil structure.
• According to another aspect of the present invention there is provided a system for a medical apparatus comprising: a tube member having a distal end and a proximal end; and a sheath, having a distal end and a proximal end, disposed around at least a portion of the inner tube, said sheath being retractable in a proximal direction relative to the tube to perform an actuating step at the distal end of the system, by the application of an endwise tensile stress to the proximal end of the sheath, characterized in that: the tube member resists the associated radially-inward contraction of the sheath which arises from the applied tensile stress during said actuating step.
• According to various embodiments of medical surgical devices, there may be provided any, some or all of the following features either independently or in combination and according to any possible arrangement.
• The inner tube can be made of any suitable material, such as a metal or polymeric material, having a distal end and a proximal end. The inner tube may define a lumen therethrough, which may be a lumen suitable for the insertion and retraction of a guide-wire. The inner tube is highly flexible and capable of navigating the tortuous channels such as in the biliary tree, arterial or venous system within the human body, and also provides some resistance to compression.
• The wire coil, preferably a reinforcing coil, is made from a biologically compatible material, preferably a metal such as nickel-titanium alloy or stainless steel. The coil is disposed around the inner tube and provides torsional, radial and compressive reinforcement for that tube. At least one, and preferably both, of a proximal region and a distal region of the wire coil has an open-coil structure, whilst an intermediate region of the wire coil has a closed-coil structure. The wire coil is flexible and able to navigate the abovementioned tortuous passageways defined by inter-connecting blood vessels. The wire coil is elastically extendable and compressible, but will remain substantially uncompressed under the attendant compressive forces normally encountered by such a member during the routine operational procedures required to operate the medical surgical device.
• The outer tube is disposed about at least a portion of the inner tube. Preferably, the outer tube is a shrink-tube layer constraining the wire coil. The outer tube can be of any suitable material, and is preferably made from low friction PTFE. The outer tube is flexible and able to navigate tortuous bodily lumens. The outer tube gives added stability, and therefore compressive strength, to the wire coil, and prevents kinking of said coil during advancement through a tortuous passageway.
• The wire coil in combination with the inner and outer tubes can define a fluid flow path between the inner and outer tubes and along a helical path defined by the adjacent turns of the wire coil. The fluid flow path may alternatively comprise a helical or an annular path between the coil and the outer tube, or between the coil and the inner tube, for example when the coil structure is such that substantially no fluid can pass from inside the coil to outside the coil or from outside the coil to inside the coil between the adjacent turns of the closed-coil structure.
• There may be provided an outer sheath disposed around the outer tube, that advantageously has little or even no radial gap between the sheath and the outer tube. The outer sheath is made from any suitable polymeric material, and is preferably made from a thermoplastic elastomer such as the one sold by DuPont under the trademark HYTREL. Although there is preferably minimal gap between the sheath and the outer tube, there may be provided a layer of lubricious material between the two, which may be a silicone coating on the outer surface of the outer tube. The sheath may even be in a circumferentially pre-stressed condition if the outside diameter of the outer tube is selected to be greater than the unstressed inner diameter of the sheath.
• In a medical surgical device comprising an inner tube, wire coil, outer tube and sheath, the inner tube and sheath preferably extend from a proximal end to a point distal of the distal ends of the wire coil and outer tube. There may be provided at the end of the medical surgical device a tip. The tip may be formed as an atraumatic, tapered extension of the distal end of the sheath or the tip may be provided at the distal end of the inner tube, optionally as a separate element attached to the inner tube. Such an attached tip may be made from any suitable soft material such as a polyurethane like Pellethane (a registered trademark of Dow Chemical). The tip may be secured to the inner tube with a suitable adhesive, such as those sold by DYMAX Corporation.
• In one preferred embodiment, the wire coil extends proximally of the outer tube by about 10 mm and extends distally of the outer tube by about 10 mm, with the proximal region and distal region of the wire coil being within (or comprising) the portions of the coil length extending beyond the outer tube and just inside it, whilst the intermediate region is the remaining, closed-coil, main part of the length of the wire coil lying within the lumen of the outer tube.
• There may be provided near the distal end of the medical surgical device a pusher element disposed around the inner tube and adjacent the distal end of the wire coil. The pusher element can be attached to the wire coil distal end, for example by glueing with DYMAX glue. Attachment is achieved preferably without glue. One way to do this is to have an end region of the coil overlap radially outwardly over a proximally-extending annulus of the pusher and butting up against a proximal-facing shoulder of the pusher element.
• The pusher element is advantageously made from PEEK. The pusher element may comprise a relatively long, cylindrical, proximal portion and a shorter, distal shoulder portion of larger diameter, with opposed shoulder surfaces facing proximally and distally. The pusher element is suitable for receiving on the distal-facing shoulder surface a proximal end face of an annular medical device such as a stent or stent graft, the proximal end of the medical device abutting the pusher element.
• There may be provided a medical device at or near a distal end of the medical surgical apparatus. The medical device may be a self-expanding stent. The medical device can be disposed about a distal region of the inner tube which extends distally beyond the distal ends of the wire coil and outer tube. The medical device is accommodated proximal of any tip at the distal end of the medical surgical device and distal of any pusher element at the distal end of the wire coil. The medical device may be held in position by a sheath extending over at least a portion of, and preferably the entire length of, the medical device. A medical device which is a self-expanding stent or stent graft can be held within the sheath in a first, compressed state, to be released by retraction of the sheath in a proximal direction relative to the inner tube, wire coil and outer tube, the medical device being prevented from moving proximally by endwise compressive stress within the wire coil and any pusher element. When released, the medical device can expand, or be expanded, to a second, non-compressed state.
• There may be provided at the distal end of the sheath a radiopaque marker and there may be provided at the distal end of the wire coil a radiopaque marker, such that release of the medical device is indicated by a movement of the radiopaque marker on the sheath to a position aligned with the radiopaque marker at the distal end of the wire coil, which indication can be viewed using visualizing means such as radioscopy or fluoroscopy. The radiopaque markers also serve to indicate the correct positioning of the medical device within a blood vessel or other body lumen during insertion and advancement of the medical surgical apparatus.
• There may be provided at the proximal end of the medical surgical device actuating means connected, directly or indirectly, to the proximal ends of any inner tube, wire coil, outer tube or sheath. The actuating means is capable of holding the inner tube, wire coil and outer tube in place, and retracting the sheath in a proximal direction relative to the inner tube, wire coil and outer tube. The actuating means may be connected to the individual members directly, using means such as gluing, welding, etc. The inner tube and wire coil may be glued to a portion of the actuating means proximal of the portion of the actuating means to which the sheath is glued. Depending on the polymer present, the glue may be DYMAX glue.
• The actuating means may include a Luer connection that communicates with the inner tube, wire coil and outer tube, the Luer providing access to an internal lumen of the inner tube.
• The sheath may be connected to a second Luer providing access to a fluid flow path between the inner tube, outer tube and adjacent turns of the wire coil.
• The actuating means may further include a Tuohy Borst valve, preventing fluid escaping from the proximal end of the medical surgical device. The actuating means may further comprise a swivel nut to lock the position of the sheath relative to the outer tube during insertion.
• The actuating means may also provide a safety clip to prevent accidental retraction of the sheath during deployment.
• In a medical surgical device comprising a wire coil between two tubular members, and where the wire coil has an open-coil structure at a proximal region and a distal region and a closed-coil structure in an intermediate region between the distal region and proximal region, a phenomenon is created whereby it is possible to introduce fluid into and through the gaps between the turns of the coil at a proximal region and then with a pressure differential urge said fluid along a fluid flow path defined between the adjacent turns of the coil and bounded outside and inside by the outer tube and the inner tube respectively. In this way, it is possible to advance the fluid along the helical path between the turns of the coil, even in the closed-coil structure of the intermediate section. In the case where the outer tube is tight on the outer cylindrical surface of the coil, but the inner tube is less tight on the luminal cylindrical surface of the coil, fluid can flow within an annular gap between the inner tube and the turns of the coil. The open-coil structure at the distal end of the coil allows an increased volume flow of fluid to exit radially outwardly at the distal end and increases the overall flow rate. In this way, no separate lumen is required for transferring the fluid, which may be a flushing fluid or visualizing fluid, and therefore results in a reduced overall diameter of the device. Because the main supporting member is the wire coil, the device remains highly flexible for advancement through tortuous passageways, yet is resistant to compressive forces associated with the retraction of an outer sheath. Therefore, the device can be advanced through narrower blood vessels whilst maintaining the required levels of controllability and ensuring accurate deployment of any medical devices to be delivered.
• In one embodiment, an outer catheter sheath is disposed about the tube member, and the sheath extends along substantially the entire length of and distal of the tube member to enclose a compressed medical device, with the proximal end of the medical device abutting the distal end of the tube member, and the medical device having an equal or lesser diameter to the tube member when compressed. In this embodiment, no separate distal sheath is required. Because the proximal end of the medical device being inserted abuts the distal end of the inner tube member and both are covered by the outer sheath, no separate actuating member is required within the medical surgical device for proximal retraction of the sheath at the distal end, since this is achieved at a proximal end of the medical surgical device, resulting in a reduced-diameter delivery apparatus. Further, in this way, the diameter of the medical surgical device does not increase at the distal end where the medical device is located but remains constant along the entire length of the medical surgical device.
• Alternatively, for delivery of medical devices having an irreducible diameter larger than what is needed for the shaft of the delivery system, the shaft may have a diameter substantially less than the distal end of the system where the medical device is housed. Where the polymeric sheath extends for substantially the entire length of the medical surgical device, and is disposed tightly around the tube member, and a tensile stress is applied to the outer sheath when the sheath is being retracted by actuating means at the proximal end, the outer sheath would normally tend to contract radially inwards, as the endwise tensile stress increases. In preferred embodiments of the invention, this tendency is inhibited, because the tube member located closely inside the outer sheath resists this radially inward motion. Hence, the two-dimensional stress matrix formed in the thin sheath is altered and results in the sheath behaving, effectively, less elastically. This means that the sheath will not stretch when the tensile force is applied, and allows for accurate deployment of the medical device contained therein. Further, the material of the outer sheath is observed to be capable of bearing an increased endwise tensile stress before it yields. The effect can be used to enable the sheath to be made without any reinforcing wire or braided structure or with reduced wall thickness and, consequently, of smaller outside diameter. This allows the designer to achieve a reduced overall diameter of the medical surgical device.
• In a device as described above, it has been found that an inner tube member of PTFE, and an outer sheath of HYTREL with a lubricious material disposed between the two, possibly silicone, results in a very small coefficient of friction between the two layers. Indeed, these two materials behave almost as if they repel one another, which assists in retraction of the sheath for deployment of a medical device.
• Further advantage is provided because of the ease of manufacture and assembly of the surgical medical apparatus. This is due to the ease with which the selected materials can be manufactured, and also due to the small number of component parts required to build such a device. This ought to reduce manufacturing time and costs.
• It will be appreciated that the present invention is characterized by the support which the inner tube gives to the outer tube when the outer tube is in endwise tension when called upon to release from its distal end a medical implant such as a self-expanding stent. This support manifests itself in a smaller contraction of the diameter of the outer tube during release of the implant than would be the case in the absence of the inner tube. Accordingly, one way of discovering whether any particular co-axial delivery device utilises the teaching of the present disclosure is to examine the magnitude of diametrical contraction, with and without the presence of the inner tube. If the presence of the inner tube fails to reduce the amount of diametrical contraction, this would suggest that the support taught herein is not being given by the inner tube to the outer tube. In addition, the shape of the stress/elongation plot for the outer sheath is significantly different, depending whether the outer sheath is receiving support from the inner tube assembly.
• Preferred embodiments of the invention will now be described, by way of example, and with reference to the accompanying drawings in which:
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a longitudinal diametrical section through a stent delivery system according to a first embodiment of the invention;
• FIG. 2 is a longitudinal diametrical section through a stent delivery catheter according to a second embodiment of the invention; and
• FIG. 3 is a longitudinal diametrical section through one possible embodiment of a medical surgical device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIG. 1 shows a system having a proximal end and a distal end. At the proximal end there is an actuating means150,152,250,252 connected to anelongate tube member100 within the lumen of asheath202. There is alubricious coating132 applied to substantially the entire length of the tube member, which fills the annulus between the tube member and the sheath. The actuating means consists of a first connectingsection150 joined to thetube member100 and having a pair of finger loops152, and a second connecting means250 attached to thesheath202 having second manual gripping means also in the form offinger loops252. The system has acentral bore104 therethrough, suitable for the insertion and retraction of a guide wire. Thetube member100 may be a single tube of polymeric material, or it may have a composite structure. The outside surface of the tube member is made from PTFE. The sheath is made from the thermoplastic elastomer HYTREL The lubricious coating is a thin coating of silicone.
• In operation, the actuating means is held in the open position, with connectingmeans150 and250 spaced apart, whilst the distal end of the system is inserted into and advanced along a body lumen. Once the distal end has reached the treatment site, the device is operated by retracting theactuator250 proximally, which moves the actuating means to a closed position, with connectingmeans150 and250 adjacent one another. Closing the actuating means causes thesheath202 to retract in a proximal direction relative to thetube member100.
• It is conceived that there may be located at the distal end of the system any one of a range of mechanisms operated by the retraction of said sheath, although the system is most immediately contemplated as for use as a catheter to deliver a stent or similar endoluminal medical surgical devices.
• Because the sheath extends for substantially the entire length of the tube member, there will be a tensile force within the sheath during retraction, due to friction between the sheath and the distal device and the inner tube, and a resisting compressive force within the tube member. The gap between the tube member and sheath is sufficiently small to reduce radially inward contraction of the sheath under tensile stresses, thereby helping to prevent the sheath from stretching lengthwise. Further, the friction forces between the sheath and the tube member are kept small by judicious selection of the involved materials, which helps to prevent the compressive stress in the tube member from deforming it and displacing the distal tip proximally, which is particularly undesirable in an endoluminal device delivery system.
• FIG. 2 shows a cross-sectional view through a member forming part of a medical surgical apparatus. The member comprises a flexibleinner tube102, which is made from a polymeric material. At a distal end of the inner tube there is atip106, which is made from Pellethane. The inner tube and distal tip have anaxial bore104 running therethrough, which forms a guide wire lumen. Disposed around the inner tube, from the proximal end to a point near the distal end of the inner tube, is awire coil110. The wire coil is wound around the inner tube and has adistal region114, aproximal region112 and an intermediate region between the two. As illustrated, the wire coil has an open-coil structure in the distal region and proximal region, and a closed-coil structure throughout the intermediate region and in the short zones at the very proximal and distal ends of the coil. The wire-coil is made from stainless steel, providing the necessary flexibility and compression resistance.
• At the distal end of the wire coil is apusher element118. The pusher element consists of a wider, proximal flange-like portion120 and a narrowerproximal shoulder portion122 which receives radially about it the very distal end of thewire coil110. The pusher element is made from PEEK, and is either attached to the wire coil using DYMAX glue or the distal end of the coil is tight enough around thecylinder122 to need no glue. There is formed between thepusher element118 and the distal tip106 a region suitable for receiving a medical device for insertion into a body lumen. In particular, seeFIG. 3, this medical device receiving area is capable of holding a self-expanding stent, with the distal end of the stent abutting thetip106 and the proximal end of the stent disposed around a shoulder123 of the pusher element and abutting theflange portion120. The region may therefore be termed a “stent bed”.
• Disposed around the intermediate region of thewire coil110 is anouter tube124. This tube is a shrink-tube made of PTFE and fits tightly around the turns of the coil. The outer tube acts to constrain the wire coil in the desired shape and inhibits the coil from kinking during advancement of the member through a tortuous passageway, such as a body lumen. Because the outer tube is tight around the coil it inhibits the adjacent turns of the coil from overlapping one another. In this way, the wire coil structure provides good resistance to compressive forces occurring within the member. Prior to insertion of the member into a body lumen, flushing fluid can be passed through the fluid flow path defined between the inner tube, outer tube and adjacent turns of the wire coil. During a surgical procedure visualizing fluid may be transported from a proximal end of the member to a distal end of the member along the same fluid flow path. A gap between the coil and theinner tube102 is the main fluid flow path in the intermediate region of the wire coil.
• FIG. 3 shows a medical surgical device for delivering a self-expanding stent. The device comprises a proximal end and a distal end with an elongate, tubular intermediate region. The apparatus comprises aninner catheter100 and anouter sheath member200.
• The inner catheter comprises aninner tube102 made from polymeric material having alumen104 therethrough which is suitable to be used as a guide wire lumen. At the distal end of the inner tube there is atip106, made from Pellethane, glued to the distal end of the inner tube with DYMAX glue. Disposed about the inner tube, at a proximal region of the inner tube, is a rigid, stainlesssteel push rod108. A stainlesssteel wire coil110 abuts the distal end of the push rod and is disposed around substantially the remaining length of the inner tube, except for a small distal region of the inner tube proximal of the Pellethane tip. The wire coil has aproximal region112 and adistal region114 having open-coil structures and anintermediate region116 having a closed-coil structure. Abutting the distal end of the wire coil and disposed around the inner tube is apusher element118 made from PEEK consisting of a proximal flange-like portion120 and a distal shoulder portion123. The pusher element is joined to the wire coil (not shown inFIG. 3) as explained above by reference toFIG. 2. The wire coil is joined at the proximal end to the distal end of the push rod, either in like manner or in any other way chosen by a person skilled in designing stent delivery systems. Disposed around the intermediate region of the wire coil is a PTFE shrink-tube124 constraining the wire coil and preventing the coil from kinking during advancement through a tortuous passageway. This helps to increase the compression resistance of the wire coil, by preventing the adjacent turns of the coil from overlapping, without substantially reducing the flexibility of the wire coil. At the proximal end of theinner catheter100 is aLuer126 and aswivel nut128 connected to afirst part150 of a proximal actuating means.Luer126 provides access to theguide wire lumen104.
• The outer tubular member comprises asheath202 extending from near the proximal end of the inner tubular member to the distal end of the inner tube and abutting the Pellethane tip. The sheath is disposed tightly about the PTFE shrink-tube124 of theinner catheter100, leaving substantially no gap between the two, the existing gap being filled by alubricious material132, which is a silicone coating on the outer surface of the PTFE shrink-tube. The sheath is slideable in a proximal direction over the inner catheter and is made from the thermoplastic elastomer HYTREL.
• At the distal end of the sheath, on an inner surface, there is a radiopaque marker band204 for determining the location of the distal end of the surgical apparatus during insertion through a body lumen using visualizing means such as radioscopy. Thepusher120 functions as a further radiopaque marker band located at the proximal end of the stent bed. When the sheath is retracted, complete retraction is observable by the radiopaque marker band204 on the distal end of thesheath202 aligning with the radiopaque marker band130 at the distal end of thewire coil110.
• At the proximal end of the outer tubular member there is asecond part250 of the proximal actuating means, also comprising aswivel nut206 for locking the position of theouter sheath member200 relative to theinner coil member100, to prevent unwanted retraction of the sheath during insertion of the medical surgical device. There is asecond Luer208 connected with thesecond part250 of the actuating means to provide access to thefluid flow path134 defined between theinner tube102,outer tube124 and adjacent turns of thewire coil110. Access into the flow path is achieved by fluid passing into the open-coil structure of the wire coil at the proximal end, via the second Luer and then into the gaps between the coils between the inner tube and outer tube. There is further provided aTuohy Borst valve210 to prevent fluid escaping proximally from the sheath member. Disposed around a proximal region of the sheath is a rigid,tubular support member212.
• A self-expandingstent300 is contained within the apparatus at a distal region in the stent bed between thePellethane tip106 andPEEK pusher element118. The proximal end of the self-expandingstent300 abuts theflange portion120. This prevents the stent from moving proximally relative to theinner tube102 during retraction of thesheath202. The sheath is disposed over the entire length of the self-expanding stent and maintains the stent in a first, radially compressed state. When the sheath is retracted, the stent begins to expand and is held in the correct deployment position by forces from the sheath and pusher element. The operation of the medical surgical apparatus will now be described.
• Prior to the insertion into a body lumen, any air within the device is removed by passing flushing fluid from the proximal end to the distal end of the device through thefluid flow path132 via thesecond Luer208, and through thecentral lumen104 via thefirst Luer126.Swivel nut206 is tightened to lock the position of theouter sheath member200 relative to theinner coil member100. Thetip106 of the medical surgical apparatus is then inserted into a body lumen. It follows a path along a previously inserted guide wire which runs through theinner lumen104. The apparatus is advanced until the distal end reaches the treatment site.
• The position and orientation of the medical surgical apparatus within the body lumen can be visualized using a radioscope to monitor pulses of contrast fluid injected into the body lumen through theinternal lumen134 of the medical surgical device.Radiopaque markers204 and120 can then be used to correctly position the stent across the treatment zone.
• Once the stent is correctly positioned, theswivel nut206 is released, and thesheath202 can be retracted by moving the second part of the actuating means250 proximally towards the first part of the actuating means150. As the sheath is retracted, the self-expandingstent300 is released, and expands to engage and hold apart the inner wall of the body lumen. Once theradiopaque marker bands204 and120 have been observed to be aligned, the stent is fully deployed and the medical surgical apparatus can be retracted, the Pellethane tip able to return proximally through the inner lumen of the expanded stent.
• The illustrated embodiments are Examples within the scope of the clams that follow. The invention is applicable to a range of implant delivery systems beyond those for self-expanding stents. It is applicable to both over the wire and rapid exchange systems, as well as to systems which lack any guidewire lumen at all. Evidently the skilled reader will bring his/her specialist background knowledge to bear, when extracting useful teaching from the above description.

Claims (20)

What is claimed is:

1. A delivery system for a medical implant comprising:

an inner catheter including a wire coil disposed between an inner tube and an outer tube, the wire coil having a plurality of gaps between turns of the coil at a proximal and a distal region of the coil;

an outer catheter disposed about the inner catheter;

a pusher element abutting a distal end of the wire coil;

and

a flow path for liquid from a proximal end through a distal end of the system past a distal end of the inner tube of the inner catheter, the flow path including a portion passing through the gaps.

2. The delivery system ofclaim 1 wherein the outer tube is disposed over an intermediate region of the wire coil having a closed-coil structure.

3. The delivery system ofclaim 2 wherein the outer tube comprises PTFE configured to fit tightly over the wire coil preventing adjacent turns of the coil from overlapping.

4. The delivery system ofclaim 3 wherein the flow path in the intermediate region is bounded by the inner tube and the outer tube.

5. The delivery system ofclaim 4 wherein

a distal end of the wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube,

and

a distal region of the inner tube defines a medical implant bed.

6. The delivery system ofclaim 1 further comprising a self-expanding stent, having a radially expanded configuration and a radially compressed configuration, wherein the stent is disposed about a portion of the inner catheter and maintained in the collapsed configuration by the outer catheter.

7. The delivery system ofclaim 6 wherein the pusher element is attached to the inner tube proximal of a medical implant bed, the pusher element including a flange portion and a shoulder portion.

8. The delivery system ofclaim 7 wherein an adhesive is disposed between at least a section of the shoulder portion and the inner tube.

9. The delivery system ofclaim 8 wherein a distal end of wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube.

10. The delivery system ofclaim 2 wherein the flow path in the intermediate region is bounded by the inner tube and the outer tube.

11. The delivery system ofclaim 10 further comprising a self-expanding stent, having a radially expanded configuration and a radially compressed configuration, wherein the stent is disposed about a portion of the inner catheter and maintained in the collapsed configuration by the outer catheter.

12. The delivery system ofclaim 11 wherein the pusher element is attached to the inner tube proximal of a medical implant bed, the pusher element including a flange portion and a shoulder portion.

13. The delivery system ofclaim 2 wherein the pusher element is attached to the inner tube proximal of a medical implant bed, the pusher element including a flange portion and a shoulder portion.

14. The delivery system ofclaim 13 wherein the flow path in the intermediate region is bounded by the inner tube and the outer tube.

15. The delivery system ofclaim 5 wherein the flow path in the intermediate region is bounded by the inner tube and the outer tube.

16. The delivery system ofclaim 15 wherein the pusher element is attached to the inner tube proximal of a medical implant bed, the pusher element including a flange portion and a shoulder portion.

17. The delivery system ofclaim 7 wherein a distal end of wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube.

18. The delivery system ofclaim 4 wherein a distal region of the inner tube defines a medical implant bed.

19. The delivery system ofclaim 1 wherein

a distal end of the wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube,

and

a distal region of the inner tube defines a medical implant bed.

20. The delivery system ofclaim 4 wherein

a distal end of the wire coil is disposed over at least a section of the shoulder portion to secure the position of the pusher element with respect to the inner tube,

and

a distal region of the inner tube defines a medical implant bed.

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