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Patentes

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Número de publicaciónWO1994024961 A1
Tipo de publicaciónSolicitud
Número de solicitudPCT/US1994/000604
Fecha de publicación10 Nov 1994
Fecha de presentación1 Feb 1994
Fecha de prioridad23 Abr 1993
También publicado comoCA2158757A1, CA2158757C, EP0695152A1
Número de publicaciónPCT/1994/604, PCT/US/1994/000604, PCT/US/1994/00604, PCT/US/94/000604, PCT/US/94/00604, PCT/US1994/000604, PCT/US1994/00604, PCT/US1994000604, PCT/US199400604, PCT/US94/000604, PCT/US94/00604, PCT/US94000604, PCT/US9400604, WO 1994/024961 A1, WO 1994024961 A1, WO 1994024961A1, WO 9424961 A1, WO 9424961A1, WO-A1-1994024961, WO-A1-9424961, WO1994/024961A1, WO1994024961 A1, WO1994024961A1, WO9424961 A1, WO9424961A1
InventoresJoseph Edward Laptewicz, Jr., Paul Jeffrey Thompson
SolicitanteSchneider (Usa) Inc.
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos:  Patentscope, Espacenet
Covered stent and stent delivery device
WO 1994024961 A1
Resumen
A radially self-expanding stent (10) is disclosed that is circumscribed with a matrix (15) of flexible polymeric material. This matrix (15) provides a barrier to tissue and/or tumor ingrowth. A deployment device (20) for the stent (10) includes an interior tube (30) on which the stent (10) may be placed and a hose (55) folded on itself surrounding and compressing the stent (10) on the interior tube (30).
Reclamaciones  (El texto procesado por OCR puede contener errores)
CLAIMS What is claimed is: 1. A stent (10) , comprising: a first plurality of thread elements (11) each of which extends in a helix configuration along a center line of the stent and having a first common direction of winding and which are axially displaced relative to each other; a second plurality of thread elements (11) each of which extends in a helix configuration along the center line of the stent and having a second common direction of winding and being axially displaced relative to each other so as to cross the first plurality of thread elements (11) and form a plurality of interstices between each of the thread elements (11) ; the first plurality of thread elements (11) and the second plurality of thread elements (11) together define a stent inner surface and a stent outer surface; and a matrix of polymeric material (15) covering the stent so as to occlude the interstices between each of the thread elements (11) of the stent.
2. The stent (10) of claim 1 wherein the polymeric material is silicone rubber.
3. The stent (10) of claim 1 wherein the polymeric material is polyurethane.
4. The stent (10) of claim 1 wherein the polymeric material is Teflon.
5. The stent (10) of claim 1 wherein the matrix (15) occluding the interstices is about .004 inches thick.
6. The stent (10) of claim 2 wherein the matrix (15) occluding the interstices is about .004 inches thick.
7. The stent (10) of claim 3 wherein the matrix (15) occluding the interstices is about .004 inches thick.
8. The stent (10) of claim 4 wherein the matrix (15) occluding the interstices is about 0.004 inches thick.
9. The stent (10) of any of claims 1-8 wherein the matrix (15) of polymeric material extends toward the outer surface of the stent.
10. The stent (10) of any of claims 1-8 wherein the matrix (15) of polymeric material extends toward the inner surface of the stent.
11. A device (20) for implanting a stent in a body passage, comprising: an elongate inner tube (30) having a distal portion and a proximal portion wherein at least the distal portion is flexible; a proximal tube (50) coaxially disposed around the proximal portion of the elongate inner tube (30) ; a hose (55) surrounding a portion of the distal portion of the elongate inner tube (30) , the hose (55) being folded on itself to form a double- walled section having an inner wall and an outer wall and wherein the inner wall is connected to the elongate inner tube (30) and the outer wall is connected to the proximal tube (50) ; and a lubricous coating on a surface of at least one of the inner wall or the outer wall of the double-walled section of the hose (55) .
12. The device (20) of claim 11 wherein the lubricous coating is hydrophilic.
13. A device (20) for deploying a radially, self-expanding stent, comprising: an elongate inner tube (30) having a distal portion and a proximal portion wherein at least the distal portion is flexible; a radially expandable stent (10) covered by a matrix (15) of polymeric material surrounding a portion of the elongate inner tube (30) ; a proximal tube (50) coaxially disposed around the proximal portion of the elongate inner tube (30) ; a hose (55) surrounding a portion of the distal portion of the elongate inner tube (30) and the stent (10) so as to maintain the stent (10) in a radially contracted state on the elongate inner tube (30) , the hose (55) being folded on itself to form a double-walled section having an inner wall and an outer wall and wherein the inner wall is connected to the elongate inner tube (30) and the outer wall is connected to the proximal tube (50) ; and a lubricous coating on a surface of at least one of the inner wall or the outer wall of the double-walled section of the hose (55) .
14. The device (20) of claim 13 wherein the radially, self-expanding stent (10) comprises: a first plurality of thread elements (11) each of which extends in a helix configuration along a center line of the stent and having a first common direction of winding and which are axially displaced relative to each other; a second plurality of thread elements (11) each of which extends in a helix configuration along the center line of the stent and having a second common direction of winding and being axially displaced relative to each other so as to cross the first plurality of thread elements (11) and form a plurality of interstices between each of the thread elements (11) ; the first plurality of thread elements (11) and the second plurality of thread elements (11) together define a stent inner surface and a stent outer surface; and wherein the matrix (15) of polymeric material covers the stent so as to occlude the interstices between each of the thread elements (11) of the stent.
15. The device (20) of claim 13 wherein the polymeric material is silicone rubber.
16. The device (20) of claim 14 wherein the polymeric material is silicone rubber.
17. The device (20) of claim 13 wherein the polymeric material is polyurethane.
18. The device (20) of claim 14 wherein the polymeric material is polyurethane.
19. The device (20) of claim 13 wherein the lubricous coating is hydrophilic.
20. The device (20) of claim 13 wherein the lubricous coating is polyethylene oxide.
21. The device (20) of claim 13 wherein the lubricous coating is hyaluronic acid.
22. The device (20) of claim 14 wherein the lubricous coating is hydrophilic.
23. The device (20) of claim 14 wherein the lubricous coating is polyethylene oxide.
24. The device (20) of claim 14 wherein the lubricous coating is hyaluronic acid.
25. The device (20) of any of claims 13-24 wherein the matrix (15) of polymeric material is about .004 inches thick.
26. A device (20) for implanting a stent (10) in a body passage, comprising: an elongate inner tube (30) having a distal portion and a proximal portion wherein at least the distal portion is flexible; a proximal tube (50) coaxially disposed around the proximal portion of the elongate inner tube (30) ; and a hose (55) formed from lubricous material surrounding a portion of the distal portion of the elongate inner tube (30) , the hose (55) being folded on itself to form a double-walled section having an inner wall and an outer wall and wherein the inner wall is connected to the elongate inner tube (30) and the outer wall is connected to the proximal tube (50).
27. The device (20) of claim 26 further comprising a radially expandable stent (10) covered by a matrix (15) of polymeric material surrounding a portion of the elongate inner tube (30) .
28. The device (20) of claim 27 wherein the radially, self-expanding stent (10) comprises: a first plurality of thread elements (11) each of which extends in a helix configuration along a center line of the stent and having a first common direction of winding and which are axially displaced relative to each other; a second plurality of thread elements (11) each of which extends in a helix configuration along the center line of the stent and having a second common direction of winding and being axially displaced relative to each other so as to cross the first plurality of thread elements (11) and form a plurality of interstices between each of the thread elements (11) ; the first plurality of thread elements (11) and the second plurality of thread elements (11) together define a stent inner surface and a stent outer surface; and wherein the matrix (15) of polymeric material covers the stent so as to occlude the interstices between each of the thread elements of the stent.
29. The device (20) of claim 26 wherein the lubricous material is Teflon.
30. The device (20) of claim 27 wherein the lubricous material is Teflon.
31. The device (20) of claim 28 wherein the lubricous material is Teflon.
32. The device (20) of any of claims 27, 28, 30 or 31 wherein the matrix (15) of polymeric material is silicone rubber.
33. The device (20) of any of claims 27, 28, 30 or 31 wherein the matrix (15) of polymeric material is polyurethane.
34. A method of deploying a radially, self- expanding stent (10) covered by a matrix (15) of polymeric material from a device (20) having an elongate inner tube (30) having a distal portion and a proximal portion wherein the stent (10) surrounds the distal portion for delivery to a treatment site and at least the distal portion is flexible, a proximal tube (50) coaxially disposed around the proximal portion of the elongate inner tube (30) , a hose (55) surrounding a portion of the distal portion of the elongate inner tube (30) on which the stent (10) is located to maintain the stent (10) in a radially contracted state, the hose (55) being folded on itself to form a double-walled section defined by an inner wall and an outer wall and wherein the inner wall is connected to the elongate inner tube (30) and the outer wall is connected to the proximal tube (50) , comprising: injecting a lubricous fluid between the inner wall and the outer wall of the double-walled section of the hose (55) ; inserting the device (20) into a body vessel and advancing the device (20) to a treatment site in the body vessel; and moving the outer wall of the double-walled section of the hose (55) in a proximal direction away from contact with the stent (20) to allow the stent (20) to radially expand into engagement with the body vessel.
35. The method of claim 32 wherein the lubricous fluid is polyethylene glycol.
Descripción  (El texto procesado por OCR puede contener errores)

COVERED STENT AND STENT DELIVERY DEVICE Background of the Invention The present invention relates to a stent which can be used within a vessel of the body of a living animal or a living human. This invention also relates to a device for delivering the stent to the treatment site. The stent includes a flexible tubular body which has a specific diameter at an unloaded state but which can be contracted to a smaller diameter by the application of force such as by radially compressing the stent or by pulling the ends of the stent apart. This feature makes the stent particularly useful for mechanical translu inal implantation in biliary ducts, respiratory tracts, the esophagus, blood vessels or the like. The stent delivery device includes a first tube having a central lumen for accommodating a guidewire and a flexible hose folded over itself and removably surrounding the first tube. The stent is placed around the first tube and held in a radially contracted state by the flexible hose. In this manner, the stent can be delivered percutaneously and transluminally to a treatment site in a body vessel. The stent is deployed by rolling the flexible hose off of the stent to allow the stent to radially self- expand. Once the stent is deployed, the stent delivery device can be withdrawn.

Prior radially self-expanding stents have an open mesh construction. After positioning such a stent in a body vessel, tissue may grow through the spaces between the wires of the stent. In many applications, such an occurrence is not detrimental to the efficacy of the stent. Indeed in many cases such tissue ingrowth is desirable because it helps to keep the stent in place preventing migration of the stent.

However, in certain applications, tissue ingrowth could be detrimental. For example, if the stent is to be placed in a body passage that has tumor growth therein to maintain the patency of the body passage, tumor ingrowth through the stent would limit the effectiveness of the stent. Indeed tumor ingrowth could completely block the body vessel. In addition, such tumor ingrowth would permanently

"lock" the stent in place. In certain applications where the ability to remove the stent is a consideration, that is undesirable.

Prior delivery devices for radially self- expanding stents generally perform in accordance with their intended purposes. Typical prior delivery devices have a moveable tubular member that constrains the stent in a contracted state on an inner catheter. The tubular member is removed from contact with the stent to allow the stent to be deployed. In certain devices, the tubular member is folded over itself to form a double-walled section. However, such prior delivery devices may not be totally effective in delivering a stent to a treatment site. For instance, friction between the walls of the double-walled section of the moveable tubular member as the walls move past each other can make removal of the tubular member from the stent difficult. One means of minimizing this problem is by the application of pressure between the walls of the tubular member to move the walls of the tubular member away from contact with each other. However, this makes the delivery device difficult to operate. The operator of the delivery device must continuously monitor the pressure to ensure that the pressure is maintained in a certain range. If the pressure is too low, friction forces will not be overcome. If the pressure it too high, the delivery device could rupture.

Therefore, it would be desirable to provide a stent that will maintain the patency of a body vessel and reduce the tissue ingrowth through the stent. It would also be desirable to provide a stent that is removably placeable within a body vessel.

It would be further desirable to provide a stent delivery device that can deploy a stent at a treatment site with little difficulty. Summary of the Invention These and other objects are achieved by the covered stent of the present invention. The covered stent comprises a flexible tubular body, the diameter of which can be changed by radial compression of the stent or by axial movement of the ends of the body relative to each other. The covered stent takes on a specified diameter when it is left in an unloaded condition free of external forces. The body is composed of several individual, rigid but flexible thread elements each of which extends in a helix configuration with the center line of the body as a common axis. A number of such thread elements have the same direction of winding but are displaced axially relative to each other. The remaining thread elements have the opposite direction of winding and are also axially displaced to each other. Thus, each thread element crosses a number of other thread elements in an over and under braided configuration. The stent is also covered with a continuous and flexible polymeric matrix that is preferably silicone rubber. This covering limits tissue ingrowth through the stent when the stent is implanted in a body vessel. The film is preferably applied to the stent by dip coating the stent in a bath of silicone rubber and an organic solvent. The thickness of the film can be controlled by the ratio of the silicone rubber and organic solvent in the bath and by the number of dip coatings to which the stent is subjected.

The stent delivery device includes an elongate and flexible length of inner tubing with a central lumen for accommodating a guidewire. The stent is placed on this tubing in a radially contracted state for transport to the treatment site. A flexible hose surrounds the tubing and is folded over itself to form a double-walled section. This double-walled section surrounds and confines the stent in a radially contracted state on the tubing. To facilitate the movement of the flexible hose away from the stent, at least that portion of the hose that contacts itself in the double-walled section is lubricous. This lubricous characteristic can be achieved by placing a lubricous coating on the surface of the hose that contacts itself in the double-walled section of the hose, by injecting a lubricous liquid into the space between the walls of the double-walled section or by forming the flexible hose from a naturally lubricous material. This makes the stent delivery device of the present invention easy to use and makes simple the deployment of a stent therefrom.

When it is desired to deploy the stent at a treatment site, the flexible hose is rolled back proximally to first expose the distal end of the stent. This allows the operator of the stent delivery device first to align properly the distal portion of the stent in the body vessel. When proper alignment is obtained, the operator can continue to roll the flexible hose proximally to completely uncover the stent and allow it to radially self- expand into engagement with the vessel wall. Brief Description of the Drawings The above and other objects and advantages of this invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout and in which:

FIG. 1 is a perspective view of the covered stent of this invention clearly showing the braided configuration of the thread elements;

FIG. 2 is a perspective view of the covered stent of this invention in a radially contracted state clearly showing the braided configuration of the thread elements;

FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 9.

FIG. 4 is a detailed view in perspective of a portion of the stent of this invention without the covering to show the braided configuration of the thread elements;

FIG. 5 is a detailed sectional view of a portion of the stent of this invention without the covering to show the braided configuration of the thread elements;

FIG. 6 is a diagrammatic sectional view of a portion of the covered stent of this invention showing the flexible polymeric matrix located along the exterior of the stent; FIG. 7 is a view similar to the view of FIG. 6 with the flexible polymeric matrix located along the interior of the stent;

FIG. 8 is a side view of the stent delivery device of this invention with a covered stent loaded therein;

FIG. 9 is an enlarged side view of the area encircled at 9 in FIG. 8;

FIG. 10 is an enlarged side view of the area encircled at 10 in FIG. 8; and

FIGS. 11-14 are side views of a distal portion of the stent delivery device and the covered stent of the present invention in various stages of a stent deployment operation in a body vessel. Detailed Description of the Invention

In FIG. 1 there is shown an example of the covered stent 10 of the present invention in an unloaded condition. Covered stent 10 is in the form of a cylindrical tubular body. Stent 10 is formed by a number of individual thread elements 11. Some of these elements extend in helix configuration in one direction axially displaced in relation to each other having the center longitudinal axis of stent 10 as a common axis. The other elements extend in helix configuration in the opposite direction and are also axially displaced in relation to each other having the center longitudinal axis as a common axis. Thus thread elements 11 extend in two directions and cross each other in a braided over and under configuration. Thread elements 11 of stent 10 are preferably arranged symmetrically so that the same number of thread elements are used in each direction of a winding. The number of thread elements needed is a function of the diameter of stent 10 in an unloaded condition. For a stent having a diameter of 10 millimeters preferably 24 thread elements are used. Thread elements 11 are helically wound about a cylindrical mandrel. One set of thread elements is wound in one direction while the other set of thread elements is wound in the opposite direction.

Thread elements 11 should be maintained in tension. Insufficient tensile force may allow the individual thread elements to depart from their configuration causing the braided structure of stent 10 to unravel. When thread elements 11 are properly tensioned, a slight impression is formed in the overlying thread element at each intersection. See FIGS. 4 and 5. Each thread element is thus deformed such that it is bent over other thread elements and partly circumscribes these other thread elements. Generally, only the parts of the respective thread elements lying on top of the crossing thread elements as seen in the radial direction have been subject to bending. These impressions, or saddles, tend to lock the thread elements relative to one another at the intersections. This maintains the stent configuration without the need for welding or other bonding of thread elements 11 at their intersections. In addition, this allows a suitable length of the tubular braid to be cut in order to make a stent of the desired length. The cut length of the tubular braid essentially maintains its cylindrical shape at the end sections. In order to further improve the radial stability of stent 10, the axially directed angle between crossing thread elements should be at least 60°, preferably greater than about 90" and even more preferably greater than about 100* when stent 10 is in an unloaded condition. The greater the angle, the higher the stability of stent 10 under external pressure.

Thread elements 11 forming stent 10 can be made from a biocompatible and flexible yet rigid material such as various polymers, e.g. Kevlar, and metal such as stainless steel. Other materials include alloys substantially based on cobalt, chromium, nickel and molybdenum, the alloying residue being iron. In addition, thread elements 11 can be formed from a core and a tubular case surrounding the core. This configuration can enhance the radiopacity of stent 10. For example, the core can be constructed of tantalum for radiopacity while the case can be constructed of a cobalt-based alloy such as an alloy available under the brand name "Elgiloy", "Phynox" and "MP35N". Such a clad composite thread element for use in making a stent is described in commonly assigned, co-pending patent application Serial No. 08/006,216 filed on January 19, 1993, which is hereby incorporated by reference.

The diameter of stent 10 can be changed by radially compressing stent 10 or by axially displacing the ends of stent 10 relative to each other. In FIG. 2 there is illustrated how stent 10 according to FIG. 1 has been given reduced diameter by moving the ends away from each other in the direction of the arrows. Since stent 10 must engage against the wall of the body vessel in which stent 10 is to be placed with certain pressure in order to remain fixed, the diameter of stent 10 in the radially contracted state must be smaller than the diameter of stent 10 at free expansion. Stent 10 is covered by a matrix 15 of a flexible, polymeric material such as silicone rubber, polyurethane or Teflon. Other flexible and biocompatible polymers could also be used. Preferably silicone rubber is used. Matrix 15 can take the form of a film or a braided or woven covering.

Matrix 15 is preferably applied to stent 10 by dip coating. Liquid silicone rubber is mixed with an organic solvent, preferably xylene, to make the silicone rubber flowable. For a stent having a diameter of 10 mm, 24 thread elements and a braid angle of 110° and where the stent is supported in the silicone rubber and xylene bath only at the ends, a ratio of 27% silicone rubber to xylene is preferably used. Using this arrangement only one dip coating is needed to completely cover stent 10. For a stent having a diameter of 20 mm, 36 thread elements and a braid angle of 110° and where the stent is supported in the silicone rubber and xylene bath by an internal mandrel, a ratio of 18% silicone rubber to xylene is preferably used. Using this arrangement 3 to 5 dip coatings is needed to completely cover stent 10.

Additional coats could be applied to stent 10 beyond what is described above. However, if too many coats are used, the flexibility of the resulting stent will be compromised making it difficult to load the resulting stent on a delivery device or to deploy the resulting stent at a treatment site. It has been found that a coating about .004 inches thick is preferable. Alternatively, if a matrix 15 with more flexibility is desired, matrix 15 can take the form of a braided or woven covering. Stent 10 can be dip coated by supporting the ends of stent 10, by using an external mandrel or by using an internal mandrel to support stent 10 when it is dipped in the bath of silicone rubber and xylene. When stent 10 is dip coated by supporting the ends of stent 10, the silicone rubber surrounds thread elements 11 so that the silicone rubber only extends in the interstices between thread elements 11 and there is little excess silicone rubber on the outside or inside of stent 10. See FIG. 3 and FIG. 14. When stent 10 is supported by an external mandrel the silicone rubber coating tends to extend toward the outside of thread elements 11 forming stent 10. See FIG. 6. When stent 10 is supported by an internal mandrel the silicone rubber tends to extend toward the inside of thread elements 11 forming stent 10. See FIG. 7. Preferably, stent 10 should be supported at the ends or by an external mandrel during the dip coating process. The matrix resulting from this process tends to be stronger and more tear resistant so that it is better able to prevent tissue ingrowth through the interstices between thread elements 11 forming stent 10.

Although the dip coating process described above is the preferred process for covering the stent of this invention, matrix 15 can also be applied by other methods such as by injection molding or spray coating stent 10 with the polymeric material.

Stent 10 is placed on a stent delivery device 20 in a radially contracted state for delivery to the treatment site in a body vessel. Stent 10 is carried by the distal portion of delivery device 20. The proximal portion of delivery device 20 generally remains outside of the body for manipulation by the operator.

Delivery device 20 comprises an elongated, inner tube 30, preferably having an axially extending lumen 35 therethrough. A distal portion of inner tube 30 is flexible and can be made from nylon or any other suitably flexible biocompatible polymeric material. At its distal end, inner tube 30 is provided with a head 31, through which lumen 35 continues. Head 31 serves to facilitate the insertion of delivery device 20 through a narrow opening in a body vessel. The proximal portion of inner tube 30 is preferably formed from stainless steel or some other suitably rigid metal alloy. The proximal end of the distal portion of inner tube 30 is bonded to the distal end of the proximal portion of inner tube 30 in any conventional manner such as by using a standard adhesive. A proximal tube 50 surrounds the proximal portion of inner tube 30 in coaxial fashion. Preferably proximal tube 50 is formed from polyurethane. The proximal end of proximal tube 50 is connected to a valve body 40 having a side port 41. An extension tube 45 extends from side port 41 to an opening 42. This arrangement allows fluid to be injected through extension tube 45 and between proximal tube 50 and inner tube 30.

A moveable hose 55 surrounds the distal portion of inner tube 30. Hose 55 is rolled over itself to form a double-walled section. The proximal end of the inner wall 56 of the double-walled section is connected directly to inner tube 30. The proximal end of the outer wall 57 of the double-walled section is connected to the outer surface of the distal portion of proximal tube 50. These connections can be achieved by any conventional means such as by a standard adhesive. This arrangement allows hose 55 to be rolled off stent 10 placed on the distal portion of inner tube 30. By moving valve body 40 in the proximal direction, outer wall 57 of hose 55 slides proximally over inner wall 56. This causes inner wall 56 to "roll back" off of stent 10. To facilitate movement of hose 55 off of stent 10, at least that portion of inner wall 56 that contacts outer wall 57 in the area where hose 55 is folded over to form the double-walled section should be lubricous. The lubricous characteristic can be achieved by adding a lubricous substance*to this surface of hose 55, injecting a lubricous liquid between inner wall 56 and outer wall 57 or forming hose 55 from a naturally slippery material such as Teflon. In the preferred embodiment, at least the surfaces of inner wall 56 and outer wall 57 that face each other in the double-walled section are coated with a lubricous hydrophilic coating. Preferably a hydrophilic coating manufactured and sold by The Hydromer Company under the designation 2018-M is used. Other materials include polyethylene oxide and hyaluronic acid. When wet the hydrophilic coating becomes lubricous and thus reduces friction between inner wall 56 and outer wall 57 of the double-walled section of hose 55 as outer wall 57 moves past inner wall 56. This facilitates the removal of the double- walled section of hose 55 from stent 10.

Preferably, hydrophilic material is added to hose 55 during the assembly of delivery device 20. In order for the hydrophilic material to adequately bond to hose 55, the material used to manufacture hose 55 must be matched to the hydrophilic material used. It has been found that polyurethane works well as the material to form hose 55. In particular, a blend of 65D and 75D polyurethane provides sufficient flexibility to allow hose 55 to roll over itself yet still be soft enough and compatible with the hydrophilic material so it can be properly coated. Preferably the blend is composed of 50% 65D polyurethane and 50% 75D polyurethane.

During the assembly of delivery device 20, one side of hose 55 is coated with the hydrophilic material after hose 55 (outer wall 57) has been connected to proximal tube 50. Isopropyl alcohol is first applied to one side of hose 55 to clean the surface and remove the waxy film resulting from the plasticizers in the polyurethane. Next that same side of hose 55 is coated with the hydrophilic material. The surface of hose 55 should be flushed with alcohol for about 30 seconds. Similarly, that surface of hose 55 should be flushed with the hydrophilic coating for about 30 seconds. It has been found that this technique deposits sufficient hydrophilic material on inner wall 56 and outer wall 57 to allow hose 55 to be rolled back with minimal friction when the hydrophilic material is wet.

Once delivery device 20 has been assembled and is ready for use, the hydrophilic coating is wetted with physiological saline solution by injecting the solution through extension tube 45, past proximal tube 50 and into the space between inner wall 56 and outer wall 57 of the double-walled section of hose 55. Excess fluid exits from the hole 59 formed toward the distal end of the double-walled section of hose 55. In this same manner, a lubricous fluid such as polyethylene glycol can be injected into the space between inner wall 56 and outer wall 57 of the double-walled section to provide the lubricous characteristic of hose 55 in place of adding a lubricous hydrophilic material to hose 55 as described above.

To deliver stent 10 to a treatment site in a body vessel, stent 10 is placed in a radially compressed state in a surrounding relationship to the outer distal end of inner tube 30. Stent 10 is constrained on inner tube 30 by the double-walled section of hose 55. It is important that stent 10 not be confined too tightly on inner tube 30. Hose 55 should apply just enough force to stent 10 to hold stent 10 in place. The double-walled section of hose 55 can be removed from surrounding relation to stent 10 by pulling valve body 40 and proximal tube 50 in a proximal direction. The double-walled section

"rolls" off of stent 10. No sliding movement takes place between stent 10 and inner wall 56 which contacts stent 10. Along with the movement of the double-walled section in a proximal direction, the distal end of stent 10 will be exposed in a radial direction to engagement against the wall of the body vessel. See FIG. 13. As the double-walled section of hose 55 continues moving proximally, more of stent 10 expands in a radial direction until the entire length of stent 10 is exposed and engages the wall of a body vessel. See FIG. 14.

Lumen 35 is used to allow stent delivery device 20 to follow a guidewire (not shown) previously inserted percutaneously into the body vessel. Lumen 35 of inner tube 30 can also be used to introduce a contrast fluid to the area around the distal end of delivery device 20 so that the position of delivery device 20 may be easily detected for example by using X-ray technique.

Thus it is seen that a covered stent is provided that maintains the patency of a body vessel and reduces tissue ingrowth through the stent. In addition, a stent delivery device is provided that minimizes friction between moving parts and that can deploy a covered stent at a treatment site with little difficulty. One skilled in the art will appreciate that the described embodiments are presented for purposes of illustration and not of limitation and that the present invention is only limited by the claims which follow.

Citas de patentes
Patente citada Fecha de presentación Fecha de publicación Solicitante Título
WO1988001924A1 *11 Sep 198724 Mar 1988Raychem CorporationManipulator
WO1992021399A1 *5 Jun 199210 Dic 1992Rtc Inc.Non-contaminating probe
DE3329176C1 *12 Ago 198322 Nov 1984Sterimed GmbhMedical device with an insertion aid
DE3918736A1 *8 Jun 198913 Dic 1990Christian Dr VallbrachtPTFE coating for metal mesh prosthesis used in artery expansion - internal and external coatings are applied to mesh and prevent thrombosis and further arterial restriction
DE4022956A1 *19 Jul 19906 Feb 1992Sebastian Dr FreudenbergSimply positioned endo-luminal body - consists of thermoplastic-coated resistance wire with terminals, formed into cage-like structure, and placed over inflatable balloon
EP0435518A1 *13 Dic 19903 Jul 1991Med Institute, Inc.A flexible, kink-resistant catheter
EP0481365A1 *11 Oct 199122 Abr 1992Angiomed AgDevice for expanding a stenosis in a body duct
GB1205743A * Título no disponible
GB2195257A * Título no disponible
Citada por
Patente citante Fecha de presentación Fecha de publicación Solicitante Título
WO1996025897A2 *22 Feb 199629 Ago 1996Menlo Care, Inc.Covered expanding mesh stent
WO1996025897A3 *22 Feb 199621 Nov 1996Menlo Care IncCovered expanding mesh stent
WO1996032077A1 *11 Abr 199617 Oct 1996The University Of QueenslandArtificial graft prosthesis
WO1997016133A1 *1 Nov 19969 May 1997Biocompatibles LimitedBraided stent
WO2010006786A1 *15 Jul 200921 Ene 2010Acandis Gmbh & Co. KgImplant with a braided mesh structure and method for producing such an implant
EP0696446A1 *9 Ago 199514 Feb 1996Olympus Optical Co., Ltd.Intraluminally indwelling stent and method for manufacturing the same
EP0788802A3 *31 Ene 199712 Abr 2000Schneider (Usa) Inc.,Titanium alloy self-expanding stent
EP0804934A2 *27 Mar 19975 Nov 1997Schneider (Usa) Inc.,Cobalt-chromium-molybdenum alloy stent and stent-graft
EP0804934A3 *27 Mar 19974 Ago 1999Schneider (Usa) Inc.,Cobalt-chromium-molybdenum alloy stent and stent-graft
EP0824899A1 *16 Ago 199625 Feb 1998Schneider (Europe) AgEndoprothesis
EP0853465A1 *30 Ago 199622 Jul 1998Emory UniversityEndovascular support device and method of use
EP0853465A4 *30 Ago 199627 Oct 1999Univ EmoryEndovascular support device and method of use
EP1084721A3 *11 Dic 19952 May 2003Advanced Cardiovascular Systems, Inc.Polymer film for wrapping a stent structure
EP1262200A2 *1 Jun 19954 Dic 2002Genzyme CorporationInhibition of platelet adherence and aggregation
EP1262200A3 *1 Jun 199512 Mar 2003Genzyme CorporationInhibition of platelet adherence and aggregation
EP1472994A216 Ago 19993 Nov 2004Boston Scientific Scimed, Inc.Stent-graft-membrane and method of making same
EP1961401A220 Feb 200827 Ago 2008Cardiatis Société AnonymeHyperplasia plaque-preventing stent
US5575818 *14 Feb 199519 Nov 1996Corvita CorporationEndovascular stent with locking ring
US5603698 *23 Ago 199518 Feb 1997Boston Scientific CorporationProsthesis delivery system
US5628788 *7 Nov 199513 May 1997Corvita CorporationSelf-expanding endoluminal stent-graft
US5674241 *15 Jul 19967 Oct 1997Menlo Care, Inc.Covered expanding mesh stent
US5700269 *13 Nov 199523 Dic 1997Corvita CorporationEndoluminal prosthesis deployment device for use with prostheses of variable length and having retraction ability
US5716981 *7 Jun 199510 Feb 1998Angiogenesis Technologies, Inc.Anti-angiogenic compositions and methods of use
US5741333 *3 Abr 199621 Abr 1998Corvita CorporationSelf-expanding stent for a medical device to be introduced into a cavity of a body
US5755769 *11 Mar 199326 May 1998Laboratoire Perouse ImplantExpansible endoprosthesis for a human or animal tubular organ, and fitting tool for use thereof
US5758562 *30 Abr 19962 Jun 1998Schneider (Usa) Inc.Process for manufacturing braided composite prosthesis
US5824037 *3 Oct 199520 Oct 1998Medtronic, Inc.Modular intraluminal prostheses construction and methods
US5843090 *5 Nov 19961 Dic 1998Schneider (Usa) Inc.Stent delivery device
US5849037 *3 Abr 199615 Dic 1998Corvita CorporationSelf-expanding stent for a medical device to be introduced into a cavity of a body, and method for its preparation
US5888201 *13 Jun 199730 Mar 1999Schneider (Usa) IncTitanium alloy self-expanding stent
US5891191 *30 Abr 19966 Abr 1999Schneider (Usa) IncCobalt-chromium-molybdenum alloy stent and stent-graft
US5902333 *21 Ago 199511 May 1999Boston Scientific CorporationProsthesis delivery system with dilating tip
US5919224 *12 Feb 19976 Jul 1999Schneider (Usa) IncMedical device having a constricted region for occluding fluid flow in a body lumen
US5928279 *3 Jul 199627 Jul 1999Baxter International Inc.Stented, radially expandable, tubular PTFE grafts
US5968070 *11 Ago 199719 Oct 1999Cordis CorporationCovered expanding mesh stent
US5980972 *22 Sep 19979 Nov 1999Schneider (Usa) IncMethod of applying drug-release coatings
US5984964 *31 Oct 199616 Nov 1999Boston Scientific CorporationProthesis delivery system
US6010530 *18 Feb 19984 Ene 2000Boston Scientific Technology, Inc.Self-expanding endoluminal prosthesis
US6019787 *7 Oct 19971 Feb 2000Laboratoire Perouse ImplantFitting tool for use of an expansible endoprosthesis for a human or animal tubular organ
US6110198 *5 Ene 199929 Ago 2000Medtronic Inc.Method for deploying cuff prostheses
US6120536 *13 Jun 199619 Sep 2000Schneider (Usa) Inc.Medical devices with long term non-thrombogenic coatings
US6123722 *5 Ene 199926 Sep 2000Medtronics, Inc.Stitched stent grafts and methods for their fabrication
US6156064 *14 Ago 19985 Dic 2000Schneider (Usa) IncStent-graft-membrane and method of making the same
US61937454 Jun 199727 Feb 2001Medtronic, Inc.Modular intraluminal prosteheses construction and methods
US623746030 Abr 199829 May 2001Corvita CorporationMethod for preparation of a self-expanding stent for a medical device to be introduced into a cavity of a body
US627389518 May 200014 Ago 2001Corvita CorporationMethod of measuring a body cavity
US643212714 Nov 199713 Ago 2002Transvascular, Inc.Devices for forming and/or maintaining connections between adjacent anatomical conduits
US655841429 Sep 19996 May 2003Impra, Inc.Partial encapsulation of stents using strips and bands
US657931429 Oct 199917 Jun 2003C.R. Bard, Inc.Covered stent with encapsulated ends
US659261716 Ene 200115 Jul 2003Boston Scientific Scimed, Inc.Three-dimensional braided covered stent
US670945510 Oct 200023 Mar 2004Boston Scientific Scimed, Inc.Stent-graft-membrane and method of making the same
US674011511 Abr 200325 May 2004C. R. Bard, Inc.Covered stent with encapsulated ends
US67700873 May 20013 Ago 2004Bard Peripheral Vascular, Inc.Partial encapsulation of stents
US67767967 May 200117 Ago 2004Cordis CorportationAntiinflammatory drug and delivery device
US678692016 Oct 20017 Sep 2004Edwards Lifesciences CorporationRadially expandable stented tubular PTFE grafts
US700496210 May 200128 Feb 2006Schneider (Usa), Inc.Neuroaneurysm occlusion and delivery device and method of using same
US705251315 Jul 200330 May 2006Boston Scientific Scimed, Inc.Three-dimensional braided covered stent
US7211109 *10 Feb 20041 May 2007Schneider (Usa) Inc.Braided composite prosthesis
US78201937 Oct 200426 Oct 2010Angiotech Pharmaceuticals, Inc.Anti-angiogenic compositions and methods of use
US789691213 Abr 20041 Mar 2011Innovational Holdings, LlcExpandable medical device with S-shaped bridging elements
US791463910 Ago 200929 Mar 2011Bard Peripheral Vascular, Inc.Partial encapsulation of stents
US805273413 Jun 20088 Nov 2011Innovational Holdings, LlcExpandable medical device with beneficial agent delivery mechanism
US805273516 Jun 20088 Nov 2011Innovational Holdings, LlcExpandable medical device with ductile hinges
US819788131 Ago 201012 Jun 2012Conor Medsystems, Inc.Method and apparatus for loading a beneficial agent into an expandable medical device
US820643523 Feb 200926 Jun 2012Conor Medsystems, Inc.Expandable medical device for delivery of beneficial agent
US823604827 Abr 20047 Ago 2012Cordis CorporationDrug/drug delivery systems for the prevention and treatment of vascular disease
US830360928 Sep 20016 Nov 2012Cordis CorporationCoated medical devices
US833765029 Mar 201225 Dic 2012Bard Peripheral Vascular, Inc.Methods for making a supported graft
US834939022 Jul 20108 Ene 2013Conor Medsystems, Inc.Method and apparatus for loading a beneficial agent into an expandable medical device
US836153726 Oct 200729 Ene 2013Innovational Holdings, LlcExpandable medical device with beneficial agent concentration gradient
US843996822 Mar 201114 May 2013Innovational Holdings, LlcExpandable medical device for delivery of beneficial agent
US855695421 Oct 200915 Oct 2013Neovasc Medical LtdMethods for treating abnormal growths in the body using a flow reducing implant
US86173378 Feb 201131 Dic 2013Bard Peripheral Vascular, Inc.Partial encapsulation of stents
US861744117 Feb 201231 Dic 2013Bard Peripheral Vascular, Inc.Methods for making an encapsulated stent
US862306830 Sep 20117 Ene 2014Conor Medsystems, Inc.Expandable medical device with ductile hinges
US864745814 Dic 201211 Feb 2014Bard Peripheral Vascular, Inc.Methods for making a supported graft
US885861213 Sep 201314 Oct 2014Neovasc Medical Inc.Methods for treating abnormal growths in the body using a flow reducing implant
US894520228 Abr 20103 Feb 2015Endologix, Inc.Fenestrated prosthesis
US92542028 Ene 20139 Feb 2016Innovational Holdings LlcMethod and apparatus for loading a beneficial agent into an expandable medical device
US93643543 Oct 201414 Jun 2016Neovasc Medical LtdMethods for treating abnormal growths in the body using a flow reducing implant
US939310016 Nov 201119 Jul 2016Endologix, Inc.Devices and methods to treat vascular dissections
US954983518 Ago 201424 Ene 2017Endologix, Inc.Catheter system and methods of using same
US957910330 Abr 201028 Feb 2017Endologix, Inc.Percutaneous method and device to treat dissections
US968737414 Dic 201627 Jun 2017Endologix, Inc.Catheter system and methods of using same
US97007019 Jul 201211 Jul 2017Endologix, Inc.Catheter system and methods of using same
US975726216 Jul 201312 Sep 2017Endologix, Inc.Stent graft
Clasificaciones
Clasificación internacionalA61F2/90, A61M25/00, A61L31/10
Clasificación cooperativaA61F2/90, A61M25/0045, A61L31/10
Clasificación europeaA61L31/10, A61M25/00S1, A61F2/90
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