Deployment system for an endoluminal device

ES 2 568 263 T3

DESCRIPTION

Deployment system for an endoluminal device

Field of the invention

The present invention relates to means for deploying an endoluminal device within vascular or cardiac structures of an implant recipient.

Background of the invention

In recent years, several implantable medical devices have been developed to repair or reinforce cardiac and vascular structures. Some of these devices can be implanted within a vascular or cardiac structure, in particular by using so-called interventional or endovascular techniques. Interventional techniques involve surgically accessing the vascular system through a conveniently located artery or vein and introducing distal portions of a medical device assembly into the vascular system through the arterial or venous access point. Once the medical device assembly is introduced into the vascular system, it is threaded through the vasculature at an implantation site while the proximal portions of the assembly having manually operated control means remain outside the body of the implant recipient. . The medical device component of the assembly is then deposited at the implantation site and the remainder of the distal portion of the medical device assembly is removed from the vascular system through the access point.

Examples of interventional medical device assemblies include a catheter. The catheter can be used to precisely position the medical device at an implantation site, as well as to participate in the deployment of the medical device at the implantation site. Some catheters have guide wires that run their length to facilitate placement and deployment of the medical device. As an alternative to the guidewire, a catheter can be coaxial with an inner sleeve that runs the length of the catheter. The inner sleeve is used to hold an implantable medical device in position while the outer catheter is pulled, causing the device to deploy. Handles, knobs, or other manually operated control means are attached to the opposite end of the catheter in this assembly.

Some implantable medical devices, such as stents, stent grafts, or other endoluminal devices often require reconfiguration from an initial compact shape to an expanded cylindrical configuration as the device is deployed to an implantation site. These devices can be expanded by themselves due to the design and composition of their structural elements or through the use of an inflatable balloon placed inside the devices.

Self-expanding endoluminal medical devices are kept in a compact configuration in several different ways. Some devices are kept in a compact configuration simply by confining the compact devices within a catheter or similar tool. Other devices are placed inside a sleeve after compaction. In these sets, a control line is often used to help release the endoluminal device from the sheath.

In US Patent 6,352,561, issued to Leopold et al., A sheath is formed around an expandable endoluminal device and a control line is used to maintain the sheath around the endoluminal device. The sleeve is formed by folding a length of polymeric material in half and stitching the opposite edges together with the control line. The sewing pattern allows the control line to be removed from the sheath by pulling on a proximal end of the control line. As the control line is unsewn from the sheath, the endoluminal device is progressively released from its confinement within the sheath. The control line is removed from the assembly as a separate entity while the sheath remains at the implantation site.

In US Patent 5,647,857, issued to Anderson et al., An endoluminal device is held in a folded configuration over a catheter by a sheath. The assembly is provided with a control line having a free end and a fixed end on a collar component of the catheter. The sheath is removed from the endoluminal device by pulling on the control line. As the control line is pulled, it traverses and separates the sheath material from the distal end to the proximal end. As the sheath opens, the endoluminal device is released to expand. Unlike Leopold et al., The control line remains mechanically fixed in the sheath and catheter assembly after deployment of the endoluminal device.

In US Patent 6,447,540, issued to Fontaine et al., A confinement sheath is removed from around an endoluminal device with a control line traversing and separating the sheath material when a physician pulls on the sheath. much like Anderson et al. As with Leopold et al, the control line can be completely removed from the pool as a separate entity.

In US Patent 5,534,007, issued to St. Germain et al., A single wall sleeve that can be folded and shortened along its length is placed around a stent. As the distal portion of the sheath retracts, it reveals the stent. The uncovered stent is free to expand. A control line is

ES 2 568 263 T3 can be used to exert a pulling force on the foldable sheath as a means of removing the sheath from the stent. The control line remains fixed in the sheath during and after stent deployment.

US 6,254,628 (Wallace et al.) Relates to a deployment mechanism for a rolled sheet stent, comprising a tear-away sheath that functions like a banana peel. The sheath may be ridged with one or more lines of penetration and comprises a pull tab integrally formed with the sheath. When the pull tab is pulled on the proximal side, the sheath tears away from the stent.

In US Patent 6,059,813, issued to Vrba et al, a double-walled confining sleeve for an endoluminal device is described. In an assembly made of these components, the endoluminal device is positioned over a catheter shaft in a folded configuration. An outer tube is placed in slidable relationship over the catheter. The distal end of the outer tube does not extend to cover the endoluminal device. Rather, the double-walled sheath is placed over the folded endoluminal device. The inner wall of the sheath is attached to the catheter shaft near the proximal end of the endoluminal device. The outer wall of the double-walled sleeve is mechanically attached to the outer tube. Movement of the outer tube relative to the catheter causes the outer wall of the sheath to move past the inner wall of the sheath. Movement of the outer tube in the proximal direction causes the sheath to retract and expose the underlying endoluminal device. As the sheath retracts, the endoluminal device is free to expand. A control line is mechanically attached to the outer tube and serves to move the outer tube and retract the sleeve.

None of these medical device assemblies utilize a control line that is an integral part of a containment sheath. Neither are these assemblies provided with a sheath that can be transformed into a control line when the sheath is removed from around the endoluminal device. Such one-piece control line and confinement sleeve are preferably made of a thin-walled continuous material or composite thereof. The thin-walled material would be flexible and place minimal restrictions on the flexibility of an underlying endoluminal device. Thin-walled materials would also reduce the profile of the sheath and endoluminal device combination. A one-piece control line and containment sleeve would simplify the fabrication of control line-sleeve constructions by eliminating the need to mechanically attach the control line to the sleeve. A one-piece control line and containment sleeve would also eliminate concerns regarding the reliability of mechanical attachment of the control line to the sleeve. Additionally, the inclusion of materials, composites, constructions, and / or assemblies that exhibit compatibility, compressibility, resilience, and / or expandability when placed between the restrained endoluminal device and the delivery catheter would serve to cushion and retain the device. endoluminal device under the confining sheath in a delivery catheter, as well as to promote expansion of the endoluminal device in some embodiments.

Summary of the invention

The present invention relates to a deployment system for an endoluminal or endoprosthetic device as described in the appended claims.

In preferred embodiments, the endoluminal device is self-expanding as a result of the design of the device and the materials used to make the device. In other embodiments, the endoluminal device can be expanded with an inflatable balloon or other dilatation means positioned within the device. In still other embodiments, the endoluminal device is an inflatable balloon. The endoluminal device is held in a compact or folded configuration by a removable sheath. In preferred embodiments, the removable sheath is removed from around the endoluminal device by applying tension on a deployment line. The deployment line is a one-piece, continuous extension of the sheath and is made of the same material as the sheath. As the deployment line is pulled, the sheath is progressively withdrawn from around the endoluminal device and also functions as an extension of the deployment line. When the sheath has been substantially removed from around a part of the endoluminal device, that part of the endoluminal device is free to expand. Removal of the sheath can be continuous until the entire endoluminal device has been released from radial restraint. The deployment line, along with any remaining sheath material, can be removed from the implantation site through a catheter used to bring the sheathed endoluminal device to the site.

In embodiments employing an endoluminal device in the form of a stent, the sheath can be removed from around the stent by inflating a balloon or other dilating means located within a folded lumen of the stent and expanding the stent against the sheath until the sheath is removed by the action of a permanent balloon or other means of dilation. The sheath is removed with the help of the deployment line portion of the present invention and / or with a mechanism capable of storing and releasing kinetic energy. As seen in Figure 13, the mechanism is referred to herein as the active spring element 25 and is preferably in the form of spring elements incorporated in the deployment line portion and / or the sheath portion of the present invention. Alternatively, the active elastic elements may be in the form of rubber bands and elastomeric polymers, including fluoroelastomers.

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The removable cover is made of one or more thin and flexible polymeric materials, including compounds thereof. The sheath is in the form of a continuous thin-walled tube when it confines an endoluminal device. Such a thin-walled sheath exerts minimal resistance to longitudinal flexion of the underlying endoluminal device. The thin-walled sheath also reduces the profile of the sheath-endoluminal device combination, when compared to conventional limitations. In preferred embodiments, a double-walled tubular sheath is used. The double walls allow the sheath to be retracted around an endoluminal device by sliding one wall past the other wall. As the sheath is retracted, or unrolled, in this manner, the sheath portion does not rub or scrape the underlying endoluminal device. This is particularly advantageous when coatings containing drugs and / or pharmaceuticals are placed on surfaces of the endoluminal device that could be disturbed by a sheath rubbing or scraping the endoluminal device as the sheath is removed from the device.

The deployment line is formed from the same material as the removable cover and is an integral part of the cover material. In some embodiments, the deployment line portion (16) extends from the sheath portion (12, 12a) through a delivery catheter to a control knob (not shown) located at the proximal end of the catheter (Figures 3 to 7). Among these embodiments, the sheath portion extends proximally beyond the endoluminal device toward the distal end of the deployment system (Figure 5). In preferred embodiments, the sheath extends over the underlying delivery catheter a desired length to a point where the sheath portion transforms into the deployment line portion (Figure 7). In more preferred embodiments, the sheath portion extends substantially the entire length of the delivery catheter before becoming a deployment line. In the most preferred embodiment (Figure 11), at least a portion of the sheath-deployment line construction (12) is enclosed within a secondary catheter (19a), a catheter lumen, or other confining device such as a tube. expanded porous polytetrafluoroethylene. By pressing the control knob, the deployment line is actuated. Once the deployment line is actuated, the removable sheath begins to move or retract around the endoluminal device.

As the removed sheath material travels past the recoil end of the sheath, the sheath begins to transform into a deployment line. Deployment line sheath transformation generally begins at a point where the tubular sheath breaks, separates, and converges toward the deployment line material. In preferred embodiments, means are provided to initiate or maintain the transformation of the sheath on the deployment line. These means may take the form of perforations, projections, or other mechanical weaknesses embedded in the sheath material. The means can also be cutting edges or sharp surfaces on the delivery catheter.

In preferred embodiments, materials, composites, constructions, and / or assemblies that exhibit compatibility, compressibility, resilience, and / or expandability are positioned between the stent, or endoluminal device, and the delivery catheter to provide a stent mounting member. . An endoprosthesis mounting element also serves to cushion the endoluminal device when it is confined by the sheath and can promote expansion of the device when it is not. A stent mounting member also serves to anchor and retain the endoluminal device in place around an underlying catheter shaft, while minimizing the profile of the delivery system. Anchoring the endoluminal device with a stent mounting element eliminates the need to use barrier, or retention, means at each end of the endoluminal device. The absence of barrier means contributes to a reduction in the profile of the deployment system, as well as an increase in the flexibility of the distal portion of the system. The present invention may also be provided with an additional catheter or catheter lumen for the sheath-deployment line in order to prevent the deployment line portion from straying out of the general pathway established by the delivery catheter. In one embodiment, the stent mounting member is in the form of an inflatable or otherwise expandable balloon. The present invention can be used alone or in combination with other means of stent delivery. Multiple stent devices can also be administered with the present invention.

Therefore, an embodiment of the present invention is a deployment system for an endoluminal device comprising an expandable endoluminal device mounted on a delivery catheter provided with a stent mounting element, a removable sheath adapted to cover the endoluminal device, the sheath comprising a fluoropolymer material adapted to surround at least a part of the endoluminal device and maintain the device in an introduction profile, wherein the deployment system includes a deployment line that is an integral part of the sheath to effect deployment of the device, and wherein upon deployment, the sheath is separated from the endoluminal device by actuation of the deployment line, The device cover is disassembled together with the deployment line.

In another embodiment, the present invention is a deployment system for an endoluminal device comprising an expandable endoluminal device positioned over a stent mounting member and at least partially enclosed by a removable sheath, and a deployment line that is an integral part of the detachable sheath, wherein the detachable sheath can be transformed into the deployment line as the sheath is removed from the endoluminal device.

ES 2 568 263 T3

Other examples are provided in the numbered clauses below for ease of understanding.

1. - A deployment system for an endoluminal device, comprising:

a removable endolumial device mounted on a catheter device provided with a stent mounting member;

a removable sheath adapted to cover the endoluminal device, the sheath comprising a fluoropolymer material adapted to surround at least a portion of the endoluminal device and contract the device into an introductory profile;

wherein the deployment system includes a deployment line integral with the holster to effect deployment of the device; and wherein after deployment, the sheath is separated from the endoluminal device through actuation of the deployment line, the sheath being withdrawn from the device along with the deployment line.

two. - The deployment system of clause 1, in which the cover comprises an extruded tube with a fixed wall.

3. - The deployment system of clause 1, in which the sheath comprises a thin continuous film.

Four. - The deployment system of clause 1, in which the sleeve is in the form of a thin-walled extruded tube reinforced with a thin continuous film tube.

5. The deployment system of clause 1, wherein the sheath delimits a stent mounting member to a smaller profile on the delivery catheter than a stent mounting member without the sheath.

6. - The deployment system of clause 1, in which the sheath is divided to transform from a sheath into an elongated filament.

7. - The clause 6 deployment system, in which means are provided to help split from a sheath into the filament.

8. - The display system of clause 6, in which the means to help divide understand a divisor.

9. - The deployment system of clause 6, in which the means to help divide comprise a technical defect incorporated in the deployment line of the sheath.

10. - The deployment system of clause 1, in which the cover comprises a wall with a thickness of less than 0.05 mm.

eleven. - The deployment system of clause 1, in which the sheath comprises a fluoropolymer that surrounds the endoluminal device in a double layer.

12. - The deployment system of clause 10, in which one layer of the double layer is laid on top of the other layer and one layer is moved past the other layer after unfolding.

13. - The deployment system of clause 1, wherein the system includes a single catheter shaft.

14. - The deployment system of clause 1, in which the actuation of the deployment line is achieved, in part, with an active elastic element incorporated therein.

fifteen. - The deployment system of clause 13, in which the catheter shaft extends remotely beyond the endoluminal device in its introductory profile.

16. - The deployment system of clause 1, further comprising at least a portion of a second catheter placed co-axially over at least a portion of said delivery catheter.

17. - The deployment system of clause 16, in which said at least a portion of a second catheter substantially delimits said deployment line of the sheath.

18. - The deployment system of clause 1, wherein the mounting member of the endo-prosthesis is in the form of an inflatable balloon.

19. - The deployment system of clause 1, wherein the stent mounting member is non-inflatable.

twenty. - The deployment system of clause 18, in which the inflatable balloon includes polytetrafluoroethylene.

ES 2 568 263 T3

twenty-one. - The deployment system of clause 1, wherein the length of the sheath retracted from the self-expanding endoluminal device is substantially equal to the length of the deployment line during deployment of the self-expanding endoluminal device.

22. - The deployment system of clause 1, wherein the length of the sheath retracted from the self-expanding endoluminal device is essentially half the length of the deployment line displaced during deployment of the self-expanding endoluminal device.

2. 3. - The deployment system of clause 1, in which the sheath is not attached to a catheter shaft.

24. - A deployment system for an endoluminal device, comprising:

an expandable endoluminal device positioned on a mounting member of the stent and at least partially enclosed by a removable sheath; and a deployment line integral with the removable sheath, wherein the detachable sheath is convertible to the deployment line as the sheath is removed from the endoluminal device.

25. - The deployment system of clause 24, in which the sheath is in the form of an extruded tube of fine wall.

26. - The deployment system of clause 24, in which the sheath is in the form of a thin continuous film.

27. - The deployment system of clause 24, in which the sheath is in the form of a thin-walled extruded tube reinforced with a thin continuous film tube.

28. The deployment system of clause 24, wherein the sheath delimits a stent mounting member to a smaller profile on the delivery catheter than a stent mounting member without the sheath.

29. - The deployment system of clause 24, in which the removable cover is divided to convert the cover into a deployment line.

30. - The deployment system of clause 24, wherein the sheath comprises a continuous film that surrounds the endoluminal device in a double layer.

31. - The deployment system of clause 24, wherein the sheath comprises an extruded fluoropolymer tube that surrounds the endoluminal device in a double layer.

32. - The deployment system of clause 30, in which the cover is convertible in a deployment line over at least a portion of the length of the cover.

33. - The deployment system of clause 24, further comprising a catheter positioned within the endoprosthesis mounting member.

3. 4. - The deployment system of clause 24, wherein the stent mounting member is in the form of an inflatable balloon.

35. - The deployment system of clause 34, in which the inflatable balloon includes polytetrafluoroethylene.

36. - The deployment system of clause 24, wherein the mounting member of the endo-prosthesis is non-inflatable.

37. - The deployment system of clause 33, in which the catheter has a single lumen.

38. - The deployment system of clause 24, further comprising at least a portion of a second catheter placed coaxially over at least a portion of said delivery catheter.

39. - The deployment system of clause 38, in which said at least a portion of a second catheter substantially delimits said deployment line of the sheath.

40. - The deployment system of clause 33, further comprising means on the catheter to initiate the conversion of the removable sheath in the deployment line.

41. - The deployment system of clause 24, wherein the removable cover is divided by the means to initiate the conversion of the removable cover on the deployment line.

42. - The deployment system of clause 24, in which the removable cover is made of a polymeric material.

43. - The deployment system of clause 42, in which the polymeric material includes a fluoropolymer.

44. - The deployment system of clause 43, in which the fluoropolymer is polytetrafluoroethylene.

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Four. Five. - The deployment system of clause 44, wherein the polytetrafluoroethylene is porous expanded polytetrafluoroethylene.

46. - The deployment system of clause 45, wherein the porous expanded polytetrafluoroethylene is in the form of a tube.

47. - The deployment system of clause 46, in which the tube has a wall with a thickness of less than 0.05 mm.

48. The deployment system of clause 24, wherein a first portion of the removable sheath substantially surrounds at least one portion of the self-expanding endoluminal device and a second portion of the removable sheath substantially covers the first portion.

49. - The deployment system of clause 48, wherein the deployment line is integral with the second portion of the removable cover.

fifty. - The deployment system of clause 24, in which the sheath is not attached to a catheter shaft.

These improved features and other peculiarities of the deployment system of the present invention are better understood by examining the following description.

Brief description of the drawings

Figure 1 illustrates a longitudinal cross section of the present invention.

Figure 1A is an enlarged view of Figure 1.

Figure 2 illustrates a perspective view of the present invention.

Figure 3 illustrates a longitudinal cross section of the present invention.

Figure 3A is an enlarged view of Figure 3.

Figure 4 illustrates a longitudinal cross section of the present invention.

Figure 4A is an enlarged view of Figure 4.

Figure 5 illustrates a longitudinal cross section of the present invention.

Figure 5A is an enlarged view of Figure 5.

Figure 6 illustrates a longitudinal cross section of the present invention.

Figure 6A is an enlarged view of Figure 6.

Figure 7 illustrates a longitudinal cross section of the present invention.

Figure 7A is an enlarged view of Figure 7.

Figure 7B illustrates the embodiment of Figure 7A viewed from the direction indicated by the arrow.

Figure 7C illustrates the embodiment of Figure 7A viewed from the direction indicated by the arrow.

Figures 8 and 8A illustrate longitudinal cross-sectional views of the present invention positioned within a vascular or cardiac structure.

Figure 9 illustrates a longitudinal cross section of the present invention with a liner placed over a stent mounting member.

Figure 9A illustrates a longitudinal cross section of the present invention without a liner placed on a stent mounting member.

Figure 10 illustrates a longitudinal cross section of the present invention with a stent mounting member positioned between an underlying delivery catheter and an endoluminal device.

Figure 11 illustrates a longitudinal cross section of the present invention having an external catheter, or tube, positioned over substantially the entire length of a sheath-deployment line construction.

Figure 12 illustrates a longitudinal cross section of the present invention showing an endoluminal device in the form of a folded inflatable balloon having a first dimension confined to a second dimension with a sheath-deployment line of the invention.

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Figure 13 illustrates a cross section of the present invention showing an active elastic member attached to the sheath portion of the present invention as a means for removing the sheath from around an endoluminal device.

Detailed description of the invention

The present invention relates to a deployment system for an endoluminal device having a removable sheath with a deployment line or filament that forms an integral part of the sheath. As indicated by the relative difference in spacing between the x arrows and the y arrows in Figure 12, the sheath portion (12) confines the endoluminal device (18a) to a smaller profile than is possible without the sheath. The sheath radially confines the endoluminal device in a compact or collapsed configuration during storage and introduction into the vascular system of a patient. The confinement sheath maintains the endoluminal device in a compact configuration until the device is delivered with a catheter to an implantation site in a vascular or cardiac structure. At the time of deployment, the sheath is retracted from the endoluminal device. The sheath material transforms into deployment line material as the sheath is removed from the endoluminal device. As the sheath is withdrawn from the endoluminal device, the endoluminal device is free to expand. Once released from the confining sleeve, the endoluminal device can expand spontaneously or with the help of an inflatable balloon. Any remaining sheath material can be removed from the implantation site along with the deployment line.

The one-piece sheath-deployment line is preferably a flexible polymeric material that is continuous throughout the length of the construction. Preferably, the physical and mechanical properties of the sheath portion are such that they are uniform and homogeneous throughout the length of the sheath portion used to restrain the endoluminal device. Since most endoluminal devices are generally circularly cylindrical in shape, the sheath is preferably tubular in shape in order to enclose most or all of the endoluminal device. Conical, tapered or other suitable shapes are also contemplated in the present invention. The flexibility of the sleeve is enhanced by making the walls of the sleeve as thin as possible. In one embodiment of the present invention (20), the tubular sheath portion (12a) of the sheath - deployment line has a single wall (Figure 3). The deployment line portion may extend from either end of the single wall sleeve (12a). When the sheath portion is retracted around an endoluminal device, the length of the retracted sheath is substantially equal to the length of the deployment line during deployment of the endoluminal device.

In another embodiment of the present invention (10), the sheath portion (12) of the sheath - deployment line has a double wall (Figures 1, 2, and 4 to 11). In a preferred embodiment, the double-walled sleeve portion (12) is made of a polymeric material that folds back on itself. The double-walled sheath portion is positioned over the endoluminal device (14) so ​​that the fold (22) is positioned at the distal end (ie, furthest from the control knob) of the sheath portion (12). The inner wall of the sheath portion may be anchored to a portion of an underlying delivery catheter (19) proximal to the endoluminal device (14). In preferred embodiments, the sheath portion (12) is not attached to the delivery catheter (19). The proximal end of the outer wall of the sheath has at least one part, or integral extension, that can be transformed into a deployment line (16). The space between the walls of the double-walled sheath portion can be filled with fluids, lubricants, pharmaceutical compositions, and / or combinations thereof. The deployment line (16) is routed through the delivery catheter (19) to a control knob (not shown) located at the proximal end of the deployment system (10). Alternatively, a separate catheter (13) or catheter lumen (11) is provided for the deployment line (Figures 4 and 1, respectively). These embodiments provide additional confinement to the deployment line portion, particularly when small radius bends or bends are anticipated in a patient's vasculature. In the most preferred embodiment (Figure 11), the sheath portion of the sheath construction - deployment line extends substantially the entire length of the delivery catheter (19) and is confined within a separate catheter (19a) or lumen. catheter. The deployment line portion is formed near the proximal end of the deployment system and is attached to a control knob (not shown).

Preferably, the physical and mechanical properties of the sheath portion are such that they are uniform and homogeneous throughout the length of the sheath portion used to restrain the endoluminal device. When the sheath portion is retracted around an endoluminal device, the length of the retracted sheath is basically half the length of the deployment line displaced during deployment of the endoluminal device. This two-to-one relationship between the length of the retracted deployment line and the length of the removed sheath material reduces the effect of pulling too fast or too hard on the deployment line when releasing the endoluminal device from the sheath.

Fluoropolymer materials are preferred for making collapsible tubular restraint deployment line-sheath constructions of the present invention. The fluoropolymer materials used in the present invention are strong, thin, and lubricating. The lubricity of fluoropolymer materials is especially advantageous in embodiments that utilize a sheath-deployment line having walls that slide over one another or over an endoluminal device. Preferred fluoropolymer materials are porous expanded polytetrafluoroethylene materials alone or in combination with fluorinated ethylenepropylene materials. Most of the preferred fluoropolymer materials are strong and thin, such as those described in Example 2, to

ES 2 568 263 T3 continued. The sheath - deployment line is made by building a suitable tube from layers of film and / or membrane. The sheath - deployment line can also be constructed from extrusions of polymeric materials. The extrusions can be used alone or in combination with film / membrane materials. Once constructed, a significant portion of the tube becomes filamentous by winding and heating.

The sheath is transformed into a deployment line by pulling the deployment line and causing the sheath material to separate and converge into a single filament. As the sheath material is transformed into a deployment line by this process, the edge of the sheath that delivers material to the deployment line recedes causing the sheath to retract from around the endoluminal device. As a portion of the sheath retracts, the portion of the endoluminal device confined by the sheath is released to expand (Figures 8 -. 8A). Optionally, means is provided to the deployment system that initiates or maintains the transformation of the sheath on the deployment line. As shown in Figure 7, the means includes perforations (71), cuts (72), or other technical defect introduced into the sheath material. As shown in Figure 5, the means also includes cutters (21) or other sharp edges on the delivery catheter. Such cutting means can be formed on the delivery catheter by exposing a reinforcing stainless steel strand from within the catheter and adapting the strand to sever the sheath portion.

In the preferred embodiment of the present invention, materials, composites, constructions, and / or assemblies that exhibit compatibility, compressibility, resilience, and / or expandability are positioned between the endoluminal device and the delivery catheter to form a " assembly of endoprosthesis (18) ". The stent mounting member can be covered (15) or uncovered (Figure 9). At least a portion of the endoluminal device is snapped into a covered or uncovered stent mounting member to anchor the endoluminal device in the delivery catheter and prevent the endoluminal device from moving along the length of the catheter. Materials with a tacky surface are useful with the stent mounting element, particularly in combination with a lubricating sheath material. The stent mounting element eliminates the need to use barrier, or retention, means at the proximal and distal end of the endoluminal device. In addition to the flexibility imparted to the deployment system without the barrier means, the profile of the combination sheath and endoluminal device is reduced without the barrier means. In yet another embodiment, the stent mounting member is in the form of an inflatable balloon (Figure 10, part 18a). Suitable materials for the stent mounting member include, but are not limited to, silicones, silicone foams, polyurethane, polyurethane foams, and polytetrafluoroethylene foams or combinations thereof. The stent mounting member is attached to the outer wall of the delivery catheter with adhesives, heat, or other suitable means.

A non-inflatable stent mounting member is preferably enclosed with a cover (15) in the form of a polymeric material. The polymeric material is preferably a fluoropolymer-based material. Porous expanded polytetrafluoroethylene is the preferred fluoropolymer for enclosing the compressible material. Other suitable polymeric materials include, but are not limited to, silicone, polyurethane, polyester, and the like.

Examples

Example 1

This example describes the construction of a deployment system of the present invention. Construction of the system begins with preparing a distal catheter shaft to receive an expandable stent. Once the distal catheter was prepared, the expandable stent was placed within a sheath - deployment line. The distal catheter portion of this combination was attached to a main catheter shaft. The deployment line portion was then routed through the main catheter to a control knob. The control knob was part of a connector located proximally on the main catheter. The sheath portion of the sheath - deployment line was in the form of a single wall tube.

A three inch long tubular material was obtained from Burnham polymeric, Inc., Glens Falls, NY for use as a distal catheter shaft. The tube was made from a polyether block amide material, commonly known as PEBAX® resin and was reinforced with a stainless steel braid. The outer diameter (OD) was 1.01mm and the inner diameter (ID) was 0.76mm. A stent mounting member in the form of a compressible material was then placed over the catheter.

To place the stent mounting member on the catheter, the catheter was mounted on a mandrel having an outer diameter of 0.74 mm. A porous expanded polytetrafluoroethylene (ePTFE) film was obtained in accordance with the teachings of US Patent 5,814,405, issued to Branca. A discontinuous fluorinated ethylenepropylene (FEP) coating was applied to one side of the ePTFE material in accordance with US Patent 6,159,565, issued to Campbell et al .. One edge of the two inch wide ePTFE-FEP composite film was heat fixed to the catheter shaft. After initial fixation, the film was wrapped around the catheter shaft forty-five (45) times under light tension. With every fifth turn of the film, and over the final layer, the film further fixed itself with the heat supplied by a soldering iron.

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This procedure provided a stent mounting element in the form of a compressible material, or flexible pillow, on the distal catheter shaft. The expandable stent was mounted on the stent mounting element. The stent mounting member provides a means of retaining an expandable stent on the catheter shaft during storage, administration to an implantation site, and deployment of the expandable stent at the implantation site. Optionally, the stent mounting member can be reinforced with a thin coating of an elastomeric material such as silicone, urethane, and / or a fluoroelastomer.

An eight (8) cell 6mm diameter nitinol stent was obtained from Medinol Ltd., Tel-Aviv, Israel. The stent was placed over the stent mounting member of the catheter in an expanded state. The combination was placed within a machine having a mechanical iris that compacts or compresses the stent portion of the assembly onto the stent mounting member. While held in the mechanical iris machine, the stent lowered its temperature from room temperature (22 ° C) to approximately five degrees Celsius (5 ° C). At the reduced temperature, the iris machine was operated to compact, or fold, the stent over the stent mounting member. While in the cooled and compressed configuration, the catheter, stent mount, and stent were placed within a sheath-deployment line of the present invention.

The sheath - deployment line having a length equal to or greater than the length of the final deployment system was made in the following manner. A length of stainless steel mandrel (1 m) measuring 1.89 mm in diameter was covered with a tubular extruded ePTFE material having a total length of approximately 200 cm. The tubular ePTFE material had an outer diameter of 1.41 mm, a wall thickness of 0.05 mm, and a mean longitudinal tensile strength of 3.52 kgf with a mean circumferential strength of 0.169 kgf. The tubular ePTFE material also had a mean mass / length of 0.0473 g / ft with a mean matrix tensile strength of 69.125 PSI. At one end (proximal end), the tubular ePTFE material was crowded onto the mandrel, while the opposite end (distal end) of the ePTFE material remained smooth on the mandrel.

The first few centimeters of the tubular ePTFE material were sacrificed and the next 5 cm from the distal end (smooth end) of the extruded ePTFE material was then reinforced with a fluoropolymer material composed as follows. The ePTFE covered mandrel was attached to retaining clips on a film wrapping machine. A first reference line located approximately 5 cm from the end of the smooth part of the extruded ePTFE material was drawn circumferentially around the material with a permanent marker (Sharpie®). A 5 cm wide composite membrane made of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylenepropylene (FEP) was applied proximally from the first reference line onto the extruded ePTFE material so that the FEP part of the material membrane composite was against extruded ePTFE material. The composite membrane was wound around the ePTFE covered mandrel twice so that the main strength of the extruded ePTFE material was oriented perpendicular to the longitudinal axis of the mandrel. The composite membrane was initially glued in place over the extruded ePTFE material with heat applied with a soldering iron. The composite ePTFE / FEP material had a density of approximately 2.14 g / cm³, a thickness of 0.005 mm and tensile strengths of approximately 340 KPa (approximately 49,000 psi) in a first direction and approximately 120 KPa (approximately 17,000 psi) in a second direction (perpendicular to the first direction). Tensile measurements were carried out on an Instron Tensile Machine (Instron Corporation, Canton, MA) at 200 mm / min., And at a loading rate with a 2.5 cm (one inch) jaw spacing.

The material of the sheath construction - deployment line adjacent to the reinforced portion was smoothed along the mandrel and a second reference line was drawn around the material 5 cm from the first reference line.

A second part of the sheath construction - deployment line was reinforced as follows. A second reference line was drawn around the extruded ePTFE material 5 cm from the proximal end of the first reinforced part. Using the second reference line to align a 2 cm wide strip of the aforementioned ePTFE / FEP composite membrane, the composite membrane was wrapped once around the remaining part of the extruded ePTFE material. to form a second reinforced part of the sheath - deployment line of the present invention. The second reinforced part had a length of approximately 2 cm. The composite reinforcing membrane material was attached to the extruded ePTFE material as described above, with the exception that the main strength component of the material was parallel to the axis of the mandrel.

Any air trapped in the construction was removed by applying a sacrificial layer of ePTFE tightly around the construction. An inch wide ePTFE film was helically overwound around the reinforced portion of the construction. Two layers of the ePTFE film were applied in one direction and two layers were applied in the opposite direction. The sacrificial layer construction was then placed in an oven heated to 320 ° C for eight minutes. Upon removal from the hot oven, the combination was allowed to cool to room temperature. The sacrificial ePTFE material was then removed.

ES 2 568 263 T3

The construction was then removed from the mandrel and another mandrel (1.83 mm diameter x 12 inches long) was inserted into the reinforced end of the construction. With the mandrel supporting the reinforced end, a 5 mm long slit was made proximal to the reinforced portion of the sheath-deployment line construction. A second mandrel was placed into the construction up to the 5mm gap where it exited the construction. The proximal portion of the sheath construction - deployment line was transformed into a filament by placing the proximal end in the clamps of the film wrap clamps and rotating the film wrap approximately 2,800 times while the mandrel with the reinforced construction was immobilized. . After the construction was formed into a filament, the filament was strengthened by rapidly applying heat to the filament with a 450 ° C solder. The reinforced filament was smoothed and its diameter made more uniform by passing the filament over a 1.8 cm diameter 3.8 cm long spike heated to about 320 ° C. The filament was passed over the heated pin at an angle of 45 ° with light tension. This process was repeated two more times for the entire length of the filament.

The filament portion of the sheath-deployment line of the present invention was routed through a lumen of a main catheter and connected to a control knob. The control knob was part of a connector located at the proximal end of the main catheter. When the deployment line portion was removed from the deployment line sheath, the sheath portion was retracted from around the stent.

Example 2

This example describes the construction of a deployment system of the present invention. Construction of the system begins with preparing a distal catheter shaft to receive an expandable stent. After the distal catheter was prepared, the expandable stent was placed within a sheath - deployment line. The distal catheter portion of this combination was attached to a main catheter shaft. The deployment line portion was then routed through the main catheter to a control knob. The control knob was part of a connector located proximally on the main catheter. The sheath portion of the sheath - deployment line was in the form of a double-walled tube.

A three inch long tubular material was obtained from Burnham polymeric, Inc., Glens Falls, NY for use as a distal catheter shaft. The tube was made from a polyether block amide material, commonly known as PEBAX® resin and was reinforced with a stainless steel braid. The outer diameter (OD) was 1.01mm and the inner diameter (ID) was 0.76mm. A stent mounting member in the form of a compressible material was then placed over the catheter. To place the stent mounting member on the catheter, the catheter was mounted on a mandrel having an outer diameter of 0.74 mm. A porous expanded polytetrafluoroethylene (ePTFE) film was obtained in accordance with the teachings of US Patent 5,814,405, issued to Branca. A discontinuous fluorinated ethylenepropylene (FEP) coating was applied to one side of the ePTFE material in accordance with US Patent 6,159,565, issued to Campbell et al ..

One edge of the two inch wide ePTFE-FEP composite film was heat affixed to the catheter shaft. After initial fixation, the film was wrapped around the catheter shaft forty-five (45) times under light tension. With every fifth turn of the film, and on top of the final coat, the film further sets itself with heat. This process provides a stent mounting element on the distal catheter shaft. The expandable stent is mounted on the stent mounting member. The stent mounting member provides a means of retaining an expandable stent on the catheter shaft during storage, administration to an implantation site, and deployment of the expandable stent at the implantation site. Optionally, the stent mounting member can be reinforced with a thin coating of an elastomeric material such as silicone, urethane, and / or a fluoroelastomer.

An eight (8) cell 6mm diameter nitinol stent was obtained from Medinol Ltd., Tel-Aviv, Israel. The stent was placed over the stent mounting member of the catheter in an expanded state. The combination was placed within a machine having a mechanical iris that compacts or compresses the stent portion of the assembly onto the stent mounting member. While held in the mechanical iris machine, the stent lowered its temperature from room temperature to approximately five degrees Celsius (5 ° C). At the reduced temperature, the iris machine was operated to compact, or fold, the stent over the stent mounting member. While in the cooled and compressed configuration, the catheter, stent mount, and stent were placed within a sheath-deployment line of the present invention.

The sheath - deployment line having a length equal to or greater than the length of the final deployment system was made in the following manner. A stainless steel mandrel measuring 1.73mm in diameter was covered with a sacrificial layer of ePTFE. The sacrificial ePTFE material favored sheath removal - mandrel deployment line. Two turns of a thin polytetrafluoroethylene (PTFE) membrane were applied to the mandrel. The ePTFE membrane was applied so that the main resistance of the film was oriented parallel to the longitudinal axis of the mandrel. The film was initially glued in place with heat applied with a soldering iron. The thickness of the membrane measured approximately 0.0002 (0.005 mm) and had tensile strengths of approximately 49,000 psi (approximately 340 KPa) in a first direction and approximately 17,000 psi (approximately 120 KPa) in a second direction (perpendicular to the first address). Tensile measurements were made at 200mm / min, and at a loading rate with a 1 ”(2.5cm) jaw spacing. The

ES 2 568 263 T3 membrane had a density of approximately 2.14 g / cm³. The membrane was further modified by applying a FEP coating on one side in accordance with US Patent 6,159,565, issued to Campbell et al .. Next, two turns of another ePTFE film, made according to the teachings of Bacino in US Patent 5,476,589 and, further modified with a discontinuous layer of a FEP material applied to one side of the ePTFE film, they were applied to one end of the construction (approximately 1 wide). US Patent 5,476,589.

These two turns had the main resistance direction of the film oriented perpendicular to the longitudinal axis of the mandrel. These layers of film provide additional tangential or radial strength to the sheath-roll-line construction. The mandrel and sheath-deployment line construction were placed in an air convection oven from The Grieve Corporation, Round Lake, IL., And heat treated at 320 ° C for 12 minutes. After air cooling, the ePTFE / FEP tube construction was removed from the mandrel and the sacrificial ePTFE layer was removed. In this example, a length of sheath - deployment line was provided that extended beyond the end of the stent. The additional length of the sheath - deployment line was folded over part of the sheath enclosing the stent to form a double-walled construction. The double-walled deployment line sheath had an inner wall and an outer wall. The inner wall was against the stent and the outer wall included the integral deployment line portion of the construction. The construct was then attached to a main catheter shaft using standard heat and materials.

The deployment line portion of the sheath - deployment line was made by separating the sheath - deployment line along its length from a proximal end to, but not including, the sheath portion enclosing the stent. The material thus obtained was gathered into a filament by winding the material. Heat was applied to the material to set the material into the filamentary form. The deployment line filament was routed through a lumen in the main catheter and connected to a control knob. The control knob was part of a connector located at the proximal end of the main catheter. When the deployment line portion of the sheath - deployment line was removed, the sheath portion was retracted from around the stent.

Example 3

This example describes the incorporation of means to initiate or maintain the transformation of the sheath part of the sheath - deployment line to deployment line by introducing perforations and projections provided in the sheath.

The sheath - deployment line of Example 2 is modified as follows. Before rolling up the sheath portion to form a double-walled construction and loading the stent therein, the sheath is perforated and / or provided with projections that facilitate separation of the tubular sheath as the deployment line portion is retracted. . A suitable laser for making the perforations or protrusions is a 20-watt CO2 laser from Universal Laser Systems, Scottsdale, Arizona. To form the perforations in the sleeve portion, the sleeve is placed over a sandblasted stainless steel mandrel and exposed to the laser to cut a series of holes in a portion of the tube that will later serve as the outer wall of the dual construction. Wall. The geometry of the holes can be varied depending on the application. The perforated sleeve portion is used in a deployment line system of the present invention as described in Example 2. In this example, the tension applied to the deployment line portion at the end of the catheter connector results in the sheath folding around the stent and also results in the sheath being separated by the perforations. As the sheath part is detached, the sheath material can be transformed into a deployment line.

Example 4

This example describes the incorporation of means to initiate or maintain the transformation of the sheath portion of the sheath - deployment line to deployment line by using a suitable separation means.

The main catheter of Example 2 is modified as follows. The main part of the catheter is provided with a notch in the wall 180 degrees opposed and slightly distal to the point of entry of the deployment line part into the catheter lumen. The notch is further modified to provide a small cutting edge in the notch. In one embodiment, the cutting edge is easily attached to the notch with heat, adhesives, and the like. In another embodiment, the cutting edge is formed by exposing a portion of a metal braid used to reinforce the catheter shaft and forming the braid as a cutting edge. In this example, the tension applied to the deployment line portion at the connector end of the catheter results in the sheath folding around the stent and also results in the sheath being separated by the perforations. As the sheath part is detached, the sheath material can be transformed into a deployment line.

Example 5

This example describes the construction of a deployment system of the present invention for use in the delivery and deployment of both self-expanding and balloon-expandable devices. The deployment system of this example uses a stent mounting element in the form of an inflatable balloon.

ES 2 568 263 T3

A sheath - deployment line having a length equal to or greater than the length of the final deployment system is made in the following manner. A stainless steel mandrel measuring 1.73mm in diameter is covered with a sacrificial layer of ePTFE. The sacrificial ePTFE material favors sheath removal - mandrel deployment line. Two turns of a thin polytetrafluoroethylene (PTFE) membrane are applied to the mandrel. The ePTFE membrane is applied whereby the main resistance of the film is oriented parallel to the longitudinal axis of the mandrel. The film is initially glued in place with heat applied with a soldering iron. The thickness of the membrane measured approximately 0.0002 (0.005 mm) and had tensile strengths of approximately 49,000 psi (approximately 340 KPa) in a first direction and approximately 17,000 psi (approximately 120 KPa) in a second direction (perpendicular to the first address). Tensile measurements are made at 200mm / min, and at a load rate with a 1 ”(2.5cm) jaw spacing. The membrane has a density of approximately 2.14 g / cm³. The membrane is further modified by applying a fluorinated ethylene propylene (FEP) coating on one side in accordance with US Patent 6,159,565, issued to Campbell et al .. Next, two turns of another ePTFE film, made according to Bacino's teachings in US Patent 5,476,589 and further modified with a discontinuous layer of a FEP material applied to one side of the ePTFE film, is applied at one end of the construction (approximately 1 wide). These two turns have the main resistance direction of the film oriented perpendicular to the longitudinal axis of the mandrel. These layers of film provide additional tangential or radial strength to the sheath-roll-line construction. The mandrel and sheath-deployment line construction are placed in an air convection oven from The Grieve Corporation, Round Lake, IL., And heat treated at 320 ° C for 12 minutes. After air cooling, the ePTFE / FEP tube construction is removed from the mandrel and the sacrificial ePTFE layer is removed. The placement of this construction on an expandable stent and the formation of a deployment line portion thereof are described below.

As seen in Figure 10, a NIRFlex® balloon expandable stent (14), available from Medinol Ltd, Tel-Aviv, Israel, is placed over and compacted around a deflated and folded angioplasty balloon mounted on a shaft of administration catheter (19). The angioplasty balloon is made in accordance with US Patent 5,752,934 to Campbell et al., And is available from WL Gore & Associates, Inc., Flagstaff, Ariz., Under the trade name APTERA® angioplasty balloon. The APTERA® Angioplasty Balloon serves as a stent mounting element (18a) to receive and retain the compact stent (14).

While the stent is confined in a compact configuration, a length of sheath-deployment line (12) is placed over the compact stent and extends beyond the end of the stent. The additional length of the sheath - deployment line is folded over the portion of the sheath that encloses the stent to form a double-walled construction. The double wall deployment line sleeve has an inner wall and an outer wall. The inner wall is against the stent and the outer wall includes the integral deployment line portion of the construction.

The deployment line portion of the sheath - deployment line is made by separating the sheath - deployment line along its length from the proximal end towards the distal end by a distance. The slit can vary in length from about one centimeter to substantially the entire length of the sheath construction-deployment line up to, but not including, the portion of the sheath that encloses the stent. It is preferred to form the deployment line portion near the proximal end of the delivery catheter. The material thus obtained is gathered into a filament by winding the material. Heat is applied to the material to set the material into the filamentary form. The sheath - deployment line is routed through a specific lumen in the delivery catheter and exits through a connector in which the deployment line portion is attached to a control knob. The control knob is part of a connector located at the proximal end of the main catheter. When tension is applied to the deployment line portion of the sheath - deployment line, the sheath portion retracts from around the stent. Removal of the sheath portion of the underlying stent frees the stent to expand. The NIRFlex® stent in this example is expanded by inflating the APTERA® angioplasty balloon. Once the stent has expanded, the balloon is deflated and the delivery catheter along with the sheath-deployment line construction is removed from the implant recipient. When self-expanding stents are used in the present invention, the balloon is useful as a stent mounting element.