US20040236402A1 - Partial encapsulation of stents - Google Patents

Abstract

An implantable medical device having a first and second ePTFE tube with a support layer positioned therebetween. The support layer may include a plurality of ring stents or may be a single stent structure. Slits may be cut into the first and/or second ePTFE tube to provide flexibility to the implantable medical device. These slits may be cut in any direction (longitudinally, circumferentially, diagonally, etc.) and may be oriented with respect to the support layer such that a desired degree of flexibility may be attained. The first and second ePTFE tubes may be bonded together through openings in the support layer to produce a partially encapsulated stent device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a division of application Ser. No. 09/848,740, filed May 3, 2001, which is a division of application Ser. No. 09/388,496, filed Sep. 2, 1999, now U.S. Pat. No. 6,398,803, which claims the benefit of provisional application Ser. No. 60/118,269, filed Feb. 2, 1999. This application expressly incorporates by reference the entirety of each of the above-mentioned applications as if fully set forth herein.[0001]
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• Not applicable.[0002]
REFERENCE TO A COMPACT DISK APPENDIX
• Not applicable.[0003]
BACKGROUND OF THE INVENTION
• The present invention relates generally to the field of medical devices, and more particularly, to encapsulation of stents.[0004]
• Stents and related endoluminal devices are currently used by medical practitioners to treat portions of the vascular system that become so narrowed that blood flow is restricted. Stents are tubular structures, usually of metal, which are radially expandable to hold a narrowed blood vessel in an open configuration. Such narrowing (stenosis) occurs, for example, as a result of the disease process known as arteriosclerosis. Angioplasty of a coronary artery to correct arteriosclerosis may stimulate excess tissue proliferation which then blocks (restenosis) the newly reopened vessel. While stents are most often used to “prop open” blood vessels, they can also be used to reinforce collapsed or narrowed tubular structures in the respiratory system, the reproductive system, biliary ducts or any other tubular body structure. However, stents are generally mesh-like so that endothelial and other cells can grow through the openings resulting in restenosis of the vessel.[0005]
• Polytetrafluoroethylene (PTFE) has proven unusually advantageous as a material from which to fabricate blood vessel grafts or prostheses used to replace damaged or diseased vessels. This is partially because PTFE is extremely biocompatible causing little or no immunogenic reaction when placed within the human body. This is also because in its preferred form, expanded PTFE (ePTFE), the material is light and porous and is potentially colonized by living cells becoming a permanent part of the body. The process of making ePTFE of vascular graft grade is well known to one of ordinary skill in the art. Suffice it to say that the critical step in this process is the expansion of PTFE into ePTFE following extrusion from a paste of crystalline PTFE particles. Expansion represents a controlled longitudinal stretching in which the PTFE is stretched up to several hundred percent of its original length. During the expansion process fibrils of PTFE are drawn out of aggregated PTFE particle (nodes), thereby creating a porous structure.[0006]
• If stents could be enclosed in ePTFE, cellular infiltration could be limited, hopefully preventing or limiting restenosis. Early attempts to produce a stent enshrouded with ePTFE focused around use of adhesives or physical attachment such as suturing. However, such methods are far from ideal, and suturing, in particular, is very labor intensive. More recently, methods have been developed for encapsulating a stent between two tubular ePTFE members whereby the ePTFE of one-member contacts and bonds to the ePTFE of the other member through the openings in the stent. However, such a monolithically encapsulated stent tends to be rather inflexible. In particular, radial expansion of the stent may stress and tear the ePTFE. There is a continuing need for a stent that is encapsulated to prevent cellular intrusion and to provide a smooth inner surface blood flow and yet still capable of expansion without tearing or delaminating and is relatively more flexible.[0007]
BRIEF SUMMARY OF THE INVENTION
• The present invention is directed to encapsulated stents wherein flexibility of the stent is retained, despite encapsulation.[0008]
• It is an object of this invention to provide a stent device that has improved flexibility, yet maintains its shape upon expansion.[0009]
• It is also an object of this invention to provide a stent encapsulated to prevent cellular infiltration wherein portions of the stent can move during radial expansion without stressing or tearing the encapsulating material.[0010]
• These and additional objects are accomplished by an encapsulation process that leaves portions of the stent free to move during expansion without damaging the ePTFE covering. The most basic form of this invention is produced by placing a stent over an inner ePTFE tube (e.g., supported on a mandrel) and then covering the outer surface of the stent with an outer ePTFE tube into which slits have been cut. The outer ePTFE tube is then laminated to the inner ePTFE tube through openings in the stent structure to capture the stent. By selecting the size and location of the slits, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. Not only does the slit prevent capture of the underlying PTFE, it forms a focal point for the ePTFE to flex. A more complex form of the process is to place over the stent an ePTFE sleeve into which apertures have been cut. This “lacey” outer sleeve leaves portions of the stent exposed for increased flexibility and for movement of the stent portions during expansion without damaging the ePTFE. Although a single stent can be used, these approaches lend themselves to use of a plurality of individual ring stents spaced apart along an inner ePTFE tube and covered by a “lacey” ePTFE sleeve.[0011]
• In the present invention, individual ring stents are partially encapsulated using the procedure outlined above. Preferably, ring stents of zigzag sinusoidal structure are placed “in phase” (e.g., peaks and valleys of one stent aligned with those of a neighboring stent) on the surface of a tubular ePTFE graft supported by a mandrel. A sleeve of ePTFE is cut using CO[0012]₂laser so that openings are created, resulting in a “lacey” pattern. This “lacey” sleeve is then placed over the ring stents. The resulting structure is then subjected to heat and pressure so that regions of ePTFE become laminated or fused together where the lacey sleeve contacts the tubular graft. In addition, the ends of the stent can be completely encapsulated, by known methods, to stabilize the overall structure.
• A more complete understanding of the encapsulation process will be afforded to those skilled in the art, as well as a realization of additional advantages and objects thereof, by a consideration of the following detailed description of the preferred embodiment. Reference will be made to the appended sheets of drawings which will first be described briefly.[0013]
BRIEF SUMMARY OF THE DRAWINGS
• FIG. 1 is a perspective view of a tubular ePTFE member with individual ring stents arranged thereon.[0014]
• FIG. 2 is a perspective view of the “lacey” sleeve of the present invention.[0015]
• FIG. 3 is a perspective view of the sleeve in FIG. 2 placed over the structure of FIG. 1.[0016]
• FIG. 4 is a perspective view of one configuration of the slitted sleeve of the present invention with longitudinally oriented slits.[0017]
• FIG. 5 is a perspective view of a second configuration of the slitted sleeve of the present invention with circumferentially oriented slits.[0018]
• FIG. 6 is a perspective view of a third configuration of the slitted sleeve as it is placed over the structure in FIG. 1.[0019]
• FIG. 7 is a perspective view of an alternate embodiment of the present invention.[0020]
DETAILED DESCRIPTION OF THE INVENTION
• The present invention satisfies the need for an encapsulated stent device to prevent restenosis that is flexible upon expansion and contraction so that the general structural form is retained. This is accomplished encapsulating a stent or a plurality of stent rings using an ePTFE covering into which openings have been cut.[0021]
• Referring now to the drawings, in which like reference numbers represent similar or identical structures throughout, FIG. 1 illustrates an initial step in constructing the partially encapsulated stent of the present invention. A[0022]tubular ePTFE graft20 is placed over a mandrel for the assembly of a device10 (FIG. 3). A stent is then placed over thegraft20. In a preferred embodiment, as shown in FIG. 1, a series of zigzagsinusoidal ring stents30 are placed over the outer surface of thegraft20. Alternatively, one or more stents wherein each stent comprises more than one ring or hoop (e.g., where the rings are helically connected) can be used. Thering stents30 can be made of any material but a preferred material is metal. Thezigzag ring stents30 may be assembled “in phase” with each adjacent ring stent having peaks and valleys aligned. Alternatively, theindividual stents30 can be “out of phase” to different degrees. It will be apparent that the phase relation ofadjacent stents30 will alter the lateral flexibility as well as the longitudinal compressibility of the structure. The phase relationship can be varied along the length of thedevice10, thereby altering the physical properties in different portions of thedevice10. Havingindividual ring stents30, as opposed to a single tubular stent, provides the advantage that the periodicity, or the number and precise shape of the zigzags per ring, can readily be varied along the length of the graft to influence flexibility and stability properties of the structure. Also, spacing of the individual stents (number of stents per unit length) as well as the phase relationship of stent to stent can be varied to produce stent grafts with desired properties. By placing thering stents30 over the outer surface of thetubular ePTFE graft20, the resulting structure has an inner (luminal) surface that is completely smooth to facilitate the flow of blood. However, there may be instances where thering stents30 or other tubular stents are advantageously placed in contact with the inner graft surface or on both the inner and outer surfaces, as one of ordinary skill in the art will readily appreciate.
• FIG. 2 shows the structure of a “lacey” graft comprising a sleeve of[0023]ePTFE40 into which apertures have been cut. This “lacey”graft40 is placed over thering stents30 in the preferred embodiment. The “lacey”graft40 is created by cuttingopenings44 in atubular ePTFE graft42. Theopenings44 were cut into the sleeve by a CO₂laser, although any other cutting technology could readily be employed. The “lacey”graft40 is slid over thering stents30 and the underlyingtubular graft20 to form thepreferred structure10 shown in FIG. 3. Thestructure10 is then exposed to heat and pressure, such as that caused by wrapping with PTFE tape followed by heating in an oven, thereby causing the ePTFE regions of the “lacey”graft40 to fuse or laminate to thetubular graft20 wherever they touch each other. It should be appreciated that the circumferential sections ofePTFE46 that are placed over thering stents30 can encompass many different designs. As illustrated, asleeve42 withopenings44 cut out is one way of accomplishing the goal of flexibility and stability. Theopenings44 between the rings ofePTFE46 can be altered to control the degree of flexibility and stability desired. In the preferred embodiment shown in FIG. 3, the “lacey”graft40 forms a number ofcircumferential sections46, which are intended to cover a portion of the circumference of eachring stent30, leaving the ends of the zigzags uncovered. By circumferentially covering only a portion of eachring stent30, the maximum amount of lateral flexibility is provided.
• However, circumferentially covering the[0024]individual ring stents30 without any longitudinal support would result in a structure with little longitudinal strength and stability that would be prone to “telescoping”. Thus, thelongitudinal sections48 that connect the rings ofePTFE46 are important, because thelongitudinal sections48 are completely laminated to theunderlying graft20 and act as “anti-compression” devices by resisting the shortening of the structure10 (the double thickness of ePTFE resists telescoping of the longitudinal sections48). The width of thecircumferential sections46 and thelongitudinal sections48 control longitudinal strength and stability versus lateral flexibility. By adjusting these parameters, grafts can be made more or less flexible with greater or lesser anti-compression strength. In the preferred embodiment, fourlongitudinal sections48 are formed and the ends of thestructure10 are completely encapsulated for greater stability. Of course, a larger number oflongitudinal sections48 could be formed. Also thelongitudinal sections48 may themselves zigzag or may be helically arranged depending on how theopenings44 are cut into thesleeve42. Each different structure will possess different properties. Similarly, thecircumferential sections46 can have different forms and may be undulating. There is nothing to preclude a covering with a more complex pattern where circumferential sections and longitudinal sections are difficult to discern or are even nonexistent.
• A second embodiment of the present invention can be seen in FIGS. 4-6. Instead of having a “lacey” graft structure, a slitted outer sleeve is used to provide partial encapsulation of the stent, the slits providing flexibility to the structure, allowing the stent to expand and retract more readily. In FIG. 4, four[0025]longitudinal slits52 run the length of the stent, leaving 5 to 10 mm of uncut sleeve at the ends. The slits are formed at 0°, 90°, 180°, and 270°, and are oriented to pass over a peak portion of each zigzag ring stent30 (FIG. 6). FIG. 5 showscircumferential slits62, wherein slits are cut circumferentially around thesleeve60 at spaced intervals, preferably to coincide with a stent ring. At each radial section, two slits are cut around the circumference at evenly spaced intervals. In a first radial section, the slits span from 0° to 90° and from 180° to 270°. Each successive radial section has a pair of slits which are offset 90° from the previous pair. Thus, a second radial section will have slits spanning from 90° to 180° and from 270° to 0°. Beside the configurations shown in FIGS. 4 and 5, a number of other slit configurations are possible, including diagonal and sinusoidal as will be appreciated by one skilled in the art. As shown in FIG. 6, asleeve70 is placed over thering stents30 and the underlyingtubular graft20 to form anew structure80. Thelongitudinal slits72, which are cut intosleeve70, differ from theslits52 shown in FIG. 4 in that they do not span the length of thestructure80 and are staggered around the circumference of thesleeve70. Ideally, the slits are aligned over the peaks in thezigzag ring stents30. Once theslits72 are cut into thesleeve70 using any of the known methods, thestructure80 is exposed to heat and pressure, such as that caused by wrapping with PTFE tape and heating in an oven, thereby causing the ePTFE regions of theslitted graft70 to fuse or laminate to thetubular graft20. Theslits72 in the slittedouter sleeve70 can be formed by using a C0₂laser, razor blade or any other suitable technique known in the art. The slits enhance the flexibility of the encapsulated structure and allow radial expansion without tearing of the ePTFE. In addition, a plurality of slits help the expanded graft to grip onto the vessel wall. This is particularly important where an encapsulated stent graft is spanning a region of damaged or weakened vessel as in an aneurysm. Further, during the healing process tissues readily grow into the slits further anchoring the graft to the vessel wall.
• An advantage that cutting slits into an ePTFE sleeve offers is that it is somewhat easier to manufacture than is the “lacey” graft. Because no material is removed the sleeve is somewhat stronger than a “lacey graft”. There are a multitude of configurations possible, including cutting the slits in asymmetric fashion to achieve desired results, such as using radial, longitudinal and diagonal cuts simultaneously. Moreover, a greater number of slits can be cut into a region of the structure in which greater expansion is desired.[0026]
• Although the above examples are described with the “lacey” and slitted grafts being placed over a stent which is itself placed over a tubular graft, this orientation can be readily reversed. That is, the “lacey” or slitted grafts can be placed on a mandrel; a stent or stents can be then placed over the “lacey” or slitted grafts, and a tubular graft can be then placed over the stent or stents. This results in a structure wherein part or much of the luminal surface is provided by the outer graft, providing superior healing as only a single layer of ePTFE would separate body tissues from the blood. Moreover, a structure with two “lacey” or slitted grafts is possible. As shown in FIG. 7, the[0027]openings112 in theouter graft110 are arranged out of phase with theopenings122 in theinner graft120. Such a configuration provides a blood tight structure wherein a majority of the final surface area of thedevice100 comprises a single layer separating body tissue from the circulating blood. Also, the areas occupied by the stent(s)30 and by overlap between the twografts110,120 present a barrier to cellular infiltration. The described structure has the advantage of a smaller profile when compressed because the overall amount of PTFE is reduced. In a further embodiment, a combination of the “lacey” graft and slitted graft could be produced.
• Having thus described preferred embodiments of the partial encapsulation of stents, it will be apparent by those skilled in the art how certain advantages of the present invention have been achieved. It should also be appreciated that various modifications, adaptations, and alternative embodiments thereof may be made within the scope and spirit of the present invention. For example, zigzag stent rings have been illustrated, but it should be apparent that the inventive concepts described above would be equally applicable to sinusoidal and other stent designs. Moreover, the words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus, if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself. The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. The described embodiments are to be considered illustrative rather than restrictive. The invention is further defined by the following claims.[0028]

Claims (24)

What is claimed as new and desired to be protected by Letters Patent of the United States:

1. An implantable medical device, comprising:

a first and second extruded ePTFE tube, wherein said first ePTFE tube comprises a plurality of slits formed therein; and

a radially expandable support layer comprising at least one stent, wherein said support layer is positioned between said first and second ePTFE tubes and is at least partially encapsulated therebetween.

2. The implantable medical device according toclaim 1, wherein said plurality of slits are oriented longitudinally on said first ePTFE tube.

3. The implantable medical device according toclaim 2, wherein each of said plurality of slits span a majority of the longitudinal length of said first ePTFE tube, leaving an unslitted region at both a proximal and distal end of said first ePTFE tube.

4. The implantable medical device according toclaim 3, wherein said region at both proximal and distal ends of said first ePTFE tube has a length in the range of approximately 5 mm to 10 mm.

5. The implantable medical device according toclaim 3, wherein each of said plurality of slits is approximately equivalent in length.

6. The implantable medical device according toclaim 5, wherein said plurality of slits comprise four slits spaced equidistantly around the circumference of said first ePTFE tube.

7. The implantable medical device according toclaim 2, wherein said plurality of slits are positioned in spaced apart intervals around the circumference of said first ePTFE tube.

8. The implantable medical device according toclaim 7, wherein two or more slits are positioned at each of selected circumferential positions on said first ePTFE tube.

9. The implantable medical device according toclaim 2, wherein said support layer comprises a plurality of ring stents formed in a zigzag pattern of alternating peaks and valleys.

10. The implantable medical device according toclaim 9, wherein said ring stents are positioned longitudinally such that the alternating peaks and valleys of neighboring ring stents are in phase with one another.

11. The implantable medical device according toclaim 10, wherein each of said plurality of slits is oriented to pass over either a ring stent peak or valley.

12. The implantable medical device according toclaim 1, wherein said plurality of slits are oriented circumferentially on said first ePTFE tube.

13. The implantable medical device according toclaim 12, wherein said plurality of slits are positioned in spaced apart intervals along the length of said first ePTFE tube.

14. The implantable medical device according toclaim 13, wherein two or more slits are positioned at each of selected longitudinal positions on said ePTFE tube.

15. The implantable medical device according toclaim 14, wherein two slits are positioned at each of said longitudinal positions, said slits having approximately the same arc length, each of the ends of said slits being spaced approximately equidistantly from one another.

16. The implantable medical device according toclaim 15, wherein the two slits at successive longitudinal positions are circumferentially offset from one another, such that taken together they span substantially the entire circumference of said first ePTFE tube.

17. An implantable medical device, comprising:

a first and second extruded ePTFE tube, wherein said first ePTFE tube comprises a plurality of slits formed therein, wherein said plurality of slits are oriented longitudinally on said first ePTFE tube; and

a radially expandable support layer comprising at least one stent, wherein said support layer is positioned between said first and second ePTFE tubes and is at least partially encapsulated therebetween.

18. An implantable medical device, comprising:

a first and second extruded ePTFE tube, wherein said first ePTFE tube comprises a plurality of slits formed therein, wherein said plurality of slits are oriented circumferentially on said first ePTFE tube; and

a radially expandable support layer comprising at least one stent, wherein said support layer is positioned between said first and second ePTFE tubes and is at least partially encapsulated therebetween.

19. An implantable medical device, comprising:

a first and second extruded ePTFE tube, wherein said first ePTFE tube comprises a plurality of slits formed therein; and

a radially expandable support layer comprising a plurality of ring stents formed in a zigzag pattern of alternating peaks and valleys, wherein said support layer is positioned between said first and second ePTFE tubes and is at least partially encapsulated therebetween.

20. A method for making an implantable medical device, comprising the steps of:

providing a first and second extruded ePTFE tube;

cutting a plurality of slits in said first ePTFE tube;

positioning a radially expandable support layer, comprising at least one stent, between said first and second ePTFE tubes; and

subjecting the device to heat and pressure such that said first and second ePTFE tubes bond together through openings in said support layer.

21. The method according toclaim 20, wherein the cutting step comprises cutting the plurality of slits in a longitudinal direction in said first ePTFE tube.

22. The method according toclaim 21, wherein said support layer comprises a plurality of ring stents formed in a zigzag pattern of alternating peaks and valleys, and wherein the positioning step comprises orienting the alternating peaks and valleys of neighboring ring stents in phase with one another.

23. The method according toclaim 22, wherein the positioning step further comprises positioning the slits to pass over either a ring stent peak or valley

24. The method according toclaim 20, wherein the cutting step comprises cutting the plurality of slits in a circumferential direction in said first ePTFE tube.

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