Stent delivery apparatus and method

• US 6,530,947 B1
• Filed: 08/06/1999
• Issued: 03/11/2003
• Est. Priority Date: 10/22/1993
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Shoemaker, Susan M., Peterson, Dean A., Burmeister, Paul H, Buirge, Andrew W., Euteneuer, Charles L.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/369,918
• Time in Patent Office: 1,313 Days
• Field of Search: 606/1, 606/108, 606/192, 606/194, 606/195, 606/198, 623/1.1, 623/1.11, 623/1.12, 623/1.23
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A delivery system for implantation of a self-expanding stent in a vessel consists of an elongate flexible catheter for delivering a self-expanding stent to a predetermined location in a vessel. The stent surrounds the flexible catheter near its distal end and is held in a delivery configuration where the stent has a reduced radius along its entire axial length by a stent retaining and release means. The stent retaining and release means is either one or more slipping sleeves which either contain the stent themselves or form a waterproof chamber with the stent being contained by water soluble bands or swelling bands. The stent retaining and release means can also be a pair of sleeves connected to hydraulic pistons, or a pair of sleeves connected to push/pull wires.

Claims

1. A delivery system for implantation of a stent in a vessel, comprising:

an elongate flexible catheter having proximal and distal ends for delivering a self-expanding stent to a predetermined location in a vessel;

a self-expanding stent having proximal and distal ends, the stent surrounding the flexible catheter near its distal end, the stent being in a delivery configuration where the stent has a reduced radius along its entire axial length;

swelling band stent retaining and release means for retaining the stent in the delivery configuration and for deploying the stent, comprised of at least one band made of a water swelling material, which holds the self-expanding stent in its delivery configuration against the outwardly urging force of the self-expanding stent;

band protection sleeve means extending over the entire axial length of the stent to prevent fluid access, and

retraction means for retracting the band protection sleeve means over the entire axial length of the stent, allowing fluid to access and swell the band, thereby releasing the stent to self-expand.

2. The delivery system of claim 1 wherein the self-expanding stent is a nitinol stent.

3. The delivery system of claim 2 wherein the nitinol stent reaches its transition temperature before the distal end of the catheter reaches the delivery site, and where the swelling band retains the stent in its reduced delivery radius.

4. The delivery system of claim 3 wherein the swelling band material is collagen.

5. The delivery system of claim 4 wherein the collagen swelling band takes the form of a tubular outer sleeve of collagen which axially surrounds the stent.

6. The delivery system of claim 4 wherein the collagen swelling band takes the form of a tubular inner liner of collagen which lines the inside of the stent and which retains the stent in its reduced delivery radius.

7. The delivery system of claim 5 or 6 wherein the collagen is treated with a drug.

8. A delivery system for implantation of a stent in a vessel, comprising:

an elongate flexible catheter having proximal and distal ends for delivering a self-expanding stent to a predetermined location in a vessel;

a self-expanding stent having proximal and distal ends, the stent being carried inside the catheter and is delivered by pushing the stent through the catheter to the distal end and out of the distal end using a stent pusher, the stent being in a delivery configuration where the stent has a reduced radius along its entire axial length;

swelling band stent retaining and release means for retaining the stent in the delivery configuration comprised of at least one band made of a water swelling material, which holds the self-expanding stent in its delivery configuration against the outwardly urging force of the self-expanding stent until the stent is delivered and where the fluid to swells the band, thereby releasing the stent to self-expand.

9. Delivery system for implantation of a self-expanding stent in a vessel, comprising:

elongate flexible catheter means having proximal and distal ends for delivering a self-expanding stent to a predetermined location in a vessel;

a self-expanding stent having-proximal and distal ends, the stent surrounding the flexible catheter near its distal end, the stent being in a delivery configuration where the stent has a reduced radius along its entire axial length;

stent retaining and release means for retaining the stent in the delivery configuration and for deploying the stent, the stent retaining and release means selected from the group consisting of dissolving bands, slipping sleeves, hydraulic sleeves, push/pull sleeves and swelling bands;

wherein the dissolving band stent retaining and release means is comprised of at least one water soluble band surrounding the stent and retaining the stent in the delivery configuration;

band protection sleeve means extending over the entire axial length of the stent to prevent fluid access, and retraction means for retracting the band protection sleeve means over the entire axial length of the stent, allowing fluid to access and dissolve the band, thereby releasing the stent to self-expand;

wherein the slipping sleeve stent retaining and release means is comprised of at least one sleeve retaining the stent in the delivery configuration, the sleeve being formed of a double walled section of sleeve folded over onto itself, with the end of the sleeve nearest the stent being fixedly connected to the catheter means and the other end of the sleeve connected to the catheter means with slip seal means and further including inflation means for inflating the sleeve with fluid, wherein increased fluid pressure in the sleeve causes the slip seal means end of the sleeve to move axially away from the stent, shortening the double walled section of the sleeve, thereby releasing the stent to self-expand;

wherein the hydraulic sleeve stent retaining and release means is comprised of proximal and distal sleeves, each retaining their respective proximal and distal stent portions in the delivery configuration, proximal and distal sliding seal means each carried inside a lumen of the elongate flexible catheter means and each connected by a wire to its respective proximal or distal sleeve and where fluid pressure in the proximal and distal sliding seal means lumens moves the proximal and distal sliding seal means axially apart, thereby moving the proximal and distal sleeves axially apart to release the stent to self-expand;

wherein the push/pull sleeve stent retaining and release means is comprised of proximal and distal sleeves, retaining their respective proximal and distal stent portions in the delivery configuration and each connected respectively to proximal and distal wires, each carried inside a lumen of the elongate flexible catheter means, the ends of the proximal and distal wires being movable such that the proximal and distal sleeves move axially apart to release the stent to self-expand;

wherein the swelling bands stent retaining and release means is comprised of at least one band attached to and surrounding the catheter and which is made of a water swelling material, and where the stent is pressed into and held in its delivery configuration by the water swelling material;

band protection sleeve means extending over the entire axial length of the stent to prevent fluid access, and retraction means for retracting the band protection sleeve means over the entire axial length of the stent, allowing fluid to access and swell the band, thereby releasing the stent to self-expand.

10. The delivery system of claim 9 wherein the dissolving band stent retaining and release means is selected from the group consisting of plural bands and tubular band,

wherein plural bands are comprised of a plurality of water soluble bands spaced along the stent and each surrounding the stent, the plurality of bands holding the stent in the delivery configuration, and

wherein tubular band is comprised of a tubular sleeve of water soluble material which surrounds the stent and holds the stent in the delivery configuration.

11. The delivery system of claim 10 wherein the dissolving band stent retaining and release means is constructed and arranged to allow the stent to self-expand in a predetermined manner.

12. The delivery system of claim 11 wherein the stent has a proximal region, a medial region and a distal region and where the plural bands or tubular band surrounding one of said proximal, medial or distal regions, are constructed so as to dissolve faster than the plural bands or tubular band surrounding the other said regions.

13. The delivery system of claim 12 wherein the water soluble bands are made from a material selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, mannitol, complex carbohydrates, polyethyleneoxide and mixtures thereof.

14. The delivery system of claim 13 wherein the band protection sleeve means is selected from the group consisting of protective sheath and slipping sleeve,

wherein protective sheath is comprised of a watertight sheath means which prevents fluid access to the stent, and which may be retracted to allow fluid access to the stent, thereby dissolving the plural bands or tubular band to release the stent for self-expansion;

and

wherein slipping sleeve is comprised of proximal and distal sleeves, each sleeve being formed of a double walled section of sleeve folded over onto itself and wherein the two sleeves abut to form a watertight seal which prevents fluid access to the stent, and which may be retracted to allow fluid access to the stent, thereby dissolving the plural bands or tubular band to release the stent for self-expansion.

15. The delivery system of claim 14 wherein the tubular band is thinner in one of said proximal, medial or distal regions whereby the thinner region will dissolve faster.

16. The delivery system of claim 14 wherein the tubular band is perforated, with a greater density of perforations in one of said proximal, redial or distal regions whereby the more densely perforated region will dissolve faster.

17. The delivery system of claim 14 including a pair of marker bands which are positioned axially on both sides of the stent, and which prevent axial movement of the stent.

18. The delivery system of claim 9 further wherein:

the dissolving band stent retaining and release means is comprised of a plurality of water soluble bands spaced axially along the stent and each surrounding the stent, the plurality of bands holding the stent in the delivery configuration, where the stent has proximal, medial and distal regions, and where the bands in the medial region are constructed so as to dissolve faster than the bands in the proximal and distal regions, and

where the band protection sleeve means is comprised of proximal and distal sleeves, each sleeve being formed of a double walled section of sleeve folded over onto itself and wherein the two sleeves abut to form a watertight seal which prevents fluid access to the stent, and which may be retracted to allow fluid access to the stent, thereby dissolving the plural bands or tubular band to release the stent for self-expansion.

19. The delivery system of claim 18 further including placement balloon means for seating the deployed stent into the vessel wall.

20. The delivery system of claim 19 further including catheter securing balloon means for preventing movement of the catheter in the vessel during deployment of the stent.

21. The delivery system of claim 9 wherein the slipping sleeve stent retaining and release means is comprised of proximal and distal sleeves, retaining their respective proximal and distal stent portions in the delivery configuration and wherein increased fluid pressure in the sleeves causes the slip seal means ends of each sleeve to move axially away from the stent.

22. The delivery system of claim 21 further including means for individually controlling the movement of each sleeve.

23. The delivery system of claim 22 wherein the means for individually controlling the movement of each sleeve is comprised of a separate fluid lumen for controlling the inflation of each sleeve whereby the user may selectively release the distal end of the stent first, release the proximal end of the stent first or release both ends simultaneously.

24. The delivery system of claim 23 further including placement balloon means for seating the deployed stent into the vessel wall.

25. The delivery system of claim 24 further including catheter securing balloon means for preventing movement of the catheter in the vessel during deployment of the stent.

26. The delivery system of claim 21 wherein the proximal and distal each share the same fluid inflation lumen.

27. The delivery system of claim 26 further including means for controlled release allowing release of either end of the stent prior to release of the opposite end.

28. The delivery system of claim 27 wherein the means for controlled release is comprised of varying the sleeve lengths of the proximal and distal sleeves with respect to one another.

29. The delivery system of claim 27 wherein the means for controlled release is comprised of varying the tightness of the seals of the proximal and distal sleeves to the catheter with respect to one another.

30. The delivery system of claim 27 wherein the means for controlled release is comprised of varying the outside diameter of the proximal and distal sleeves with respect to one another.

31. The delivery system of claim 27 wherein the means for controlled release is comprised of speed control bumps in the catheter means.

32. The delivery system of claim 9 wherein the slipping sleeve stent retaining and release means is comprised of a single sleeve retaining the stent in the delivery configuration and sleeve abutment means fixedly attached to the catheter and abutting the distal end of the sleeve to prevent fluid access into the slipping sleeve, and wherein increased fluid pressure in the sleeve causes the slip seal means end of the sleeve to move axially away from the stent, pulling the sleeve from the distal sleeve abutment means and releasing the stent to self-expand.

33. The delivery system of claim 9 further including means for controlled release allowing release of either end of the stent prior to release of the opposite end.

34. The delivery system of claim 33 wherein the means for controlled release is comprised of a fluid communication port between the lumens carrying the proximal and distal sliding seal means, and positioned such that increased fluid pressure moves the distal sliding seal means past the fluid communication port to allow fluid to flow into the proximal sliding seal means lumen, which moves the proximal sliding seal means proximally, whereby the distal end of the stent is release prior to the release of the proximal end.

35. The delivery system of claim 34 further including placement balloon means for seating the deployed stent into the vessel wall.

36. The delivery system of claim 35 further including catheter securing balloon means for preventing movement of the catheter in the vessel during deployment of the stent.

37. The delivery system of claim 9 wherein the push/pull sleeve stent retaining and release means proximal and distal sleeves are sized to allow the distal end to be released before release of the proximal end, whereby the stent may be retrieved if it is misplaced.

38. The delivery system of claim 9 further including placement balloon means for seating the stent into the vessel wall, and wherein the stent retaining and release means is used to recapture the placement balloon when the stent is fully deployed.

39. The delivery system of claim 38 further including catheter securing means for preventing movement of the catheter in the vessel during deployment of the stent.

40. The delivery system of claim 39 wherein the catheter securing means is comprised of balloon means.

41. The delivery system of claim 39 wherein the catheter securing means is comprised of magnet means.

49. A method of deploying a stent utilizing the delivery system of claim 40, comprising the steps of:

attaching a stent around the stent expansion means;

covering the stent using the stent covering means;

moving the distal end of the catheter means to a predetermined deployment site;

uncovering the stent, and

expanding the stent using the stent expansion means.

42. A method of deploying a stent comprising the steps of:

providing a stent delivery system comprising;

elongate flexible catheter means having proximal and distal ends for delivering a self-expanding stent to a predetermined location in a vessel;

a self-expanding stent having proximal and distal ends, the stent surrounding the flexible catheter near its distal end, the stent being in a delivery configuration where the stent has a reduced radius along its entire axial length;

stent retaining and release means for retaining the stent in the delivery configuration and for deploying the stent, the stent retaining and release means selected from the group consisting of dissolving bands, slipping sleeves, hydraulic sleeves, push/pull sleeves and swelling bands;

wherein the dissolving band stent retaining and release means is comprised of at least one water soluble band surrounding the stent and retaining the stent in the delivery configuration;

band protection sleeve means extending over the entire axial length of the stent to prevent fluid access, and retraction means for retracting the band protection sleeve means over the entire axial length of the stent, allowing fluid to access and dissolve the band, thereby releasing the stent to self-expand;

wherein the slipping sleeve stent retaining and release means is comprised of at least one sleeve retaining the stent in the delivery configuration, the sleeve being formed of a double walled section of sleeve folded over onto itself, with the end of the sleeve nearest the stent being fixedly connected to the catheter means and the other end of the sleeve connected to the catheter means with slip seal means and further including inflation means for inflating the sleeve with fluid, wherein increased fluid pressure in the sleeve causes the slip seal means end of the sleeve to move axially away from the stent, shortening the double walled section of the sleeve, thereby releasing the stent to self-expand;

wherein the hydraulic sleeve stent retaining and release means is comprised of proximal and distal sleeves, each retaining their respective proximal and distal stent portions in the delivery configuration, proximal and distal sliding seal means each carried inside a lumen of the elongate flexible catheter means and each connected by a wire to its respective proximal or distal sleeve and where fluid pressure in the proximal and distal sliding seal means lumens moves the proximal and distal sliding seal means axially apart, thereby moving the proximal and distal sleeves axially apart to release the stent to self-expand;

wherein the push/pull sleeve stent retaining and release means is comprised of proximal and distal sleeves, retaining their respective proximal and distal stent portions in the delivery configuration and each connected respectively to proximal and distal wires, each carried inside a lumen of the elongate flexible catheter means, the ends of the proximal and distal wires being movable such that the proximal and distal sleeves move axially apart to release the stent to self-expand;

wherein the swelling bands stent retaining and release means is comprised of at least one band attached to and surrounding the catheter and which is made of a water swelling material, and where the stent is pressed into and held in its delivery configuration by the water swelling material;

band protection sleeve means extending over the entire axial length of the stent to prevent fluid access, and retraction means for retracting the band protection sleeve means over the entire axial length of the stent, allowing fluid to access and swell the band, thereby releasing the stent to self-expand;

securing the stent in the delivery configuration using the stent retaining and release means;

moving the distal end of the catheter means to a predetermined deployment site;

releasing the stent using the stent retaining and release means.

43. The method of claim 42 including the further step of controlling the release of the stent such that the stent self-expands in a predetermined manner.

44. The method of claim 43 including the further step of inflating a placement balloon to seat the stent into the vessel wall.

45. The method of claim 44 including the further step of recovering the balloon used to seat the stent using the push/pull sleeve stent retaining and release means.

46. The method of claim 42 including the further step of recovering a partially deployed stent.

47. The method of claim 42 including the further step of securing the catheter to prevent movement of the catheter in the vessel during deployment of the stent.

48. Delivery system for implantation of a stent in a vessel, comprising:

elongate flexible catheter means having proximal and distal ends for delivering a stent to a predetermined location in a vessel;

stent expansion means surrounding the flexible catheter near its distal end;

a stent having proximal and distal ends, the stent surrounding the stent expansion means;

stent covering means for covering the stent, the stent covering means selected from the group consisting of slipping sleeves, hydraulic sleeves, and push/pull sleeves;

wherein the slipping sleeve stent covering means is comprised of at least one sleeve covering the stent, the sleeve being formed of a double walled section of sleeve folded over onto itself, with the end of the sleeve nearest the stent being fixedly connected to the catheter means and the other end of the sleeve connected to the catheter means with slip seal means and further including inflation means for inflating the sleeve with fluid, wherein increased fluid pressure in the sleeve causes the slip seal means end of the sleeve to move axially away from the stent, shortening the double walled section of the sleeve, thereby uncovering the stent;

wherein the hydraulic sleeve stent covering means is comprised of proximal and distal sleeves, each covering their respective proximal and distal stent portions, proximal and distal sliding seal means each carried inside a lumen of the elongate flexible catheter means and each connected by a wire to its respective proximal or distal sleeve and where fluid pressure in the proximal and distal sliding seal means lumens moves the proximal and distal sliding seal means axially apart, thereby moving the proximal and distal sleeves axially apart to uncover the stent;

wherein the push/pull sleeve stent covering means is comprised of proximal and distal sleeves, retaining their respective proximal and distal stent portions, and each connected respectively to proximal and distal wires, each carried inside a lumen of the elongate flexible catheter means, the ends of the proximal and distal wires being movable such that the proximal and distal sleeves move axially apart to uncover release the stent.