Vascular prosthesis connecting stent

• US 8,092,520 B2
• Filed: 11/09/2006
• Issued: 01/10/2012
• Est. Priority Date: 11/10/2005
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Technologies Incorporated
• Inventors: Quadri, Arshad
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US12/084,586
• Publication Number:
  US 20090216314A1
• Time in Patent Office: 1,888 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.36
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An expandable vascular stent includes an m×n array of ovals formed in a cylinder, m being the number of columns of ovals in the circumferential direction and n being the number of rows of ovals in the axial direction, and a plurality of prongs extending inwardly from the outer ends of respective ovals in rows 1 and n of the m×n array, and being arranged in facing pairs extending from axially-aligned ovals. The cylinder is expandable from an initial diameter to a pre-determined final diameter, wherein an increase in the diameter of the stent results in a substantial decrease in the length of the stent. The tube and the prongs can be made of surgical stainless steel, the tube being expandable using an angioplasty balloon; or the tube and the prongs can be made of a memory metal and the tube is self-expanding.

Claims

1. An expandable vascular stent comprising

an m×

n array of ovals formed in a cylinder having a diameter, a circumference, an axis, and a length in the direction of the axis, where m is the number of columns of ovals in the circumferential direction and n is the number of rows of ovals in the axial direction, the ovals having a short axis and a long axis, the short axis of the ovals extending in the circumferential direction and the long axis of the ovals extending in the axial direction, the cylinder being expandable from an initial diameter to a pre-determined final diameter, wherein an increase in the diameter of the stent results in a decrease in the length of the stent; and

a plurality of prongs located at rows 1 and n of the m×

n array for connecting the cylinder to a surrounding body, a first plurality of prongs located at row 1 extending generally radially outwardly from the ovals and generally toward a second plurality of prongs located at row n, and the second plurality of prongs located at row n extend generally radially outwardly from the ovals and generally toward the first plurality of prongs at row 1;

wherein when the stent is expanded to the final diameter, each of the prongs is bent at or adjacent the ovals so that an elongate first portion along the length of the prong extends radially outwardly, and each of the prongs is further bent radially inwardly relative the first portion so that an elongate second portion along the length of the prong is spaced radially outwardly from the ovals and extends in a generally axial direction.

2. The expandable vascular stent of claim 1, wherein prongs from the first plurality of prongs are arranged in facing pairs with prongs from the second plurality of prongs when the respective prongs extend from ovals that are in alignment in the axial direction.

3. The expandable vascular stent of claim 2, wherein when the stent is expanded to the final diameter, the elongate second portions of the prongs in facing pairs are approximately collinear.

4. The expandable vascular stent of claim 2, wherein prior to expansion of the cylinder, the prongs substantially conform to the shape of the cylinder and after expansion, the prongs extend outwardly, from the cylinder to engage the surrounding body.

5. The expandable vascular stent of claim 1, further comprising circumferential connectors connecting adjacent ovals to each other in the circumferential direction and axial connectors connecting adjacent ovals to each other in the axial direction.

6. The expandable vascular stent of claim 5, wherein the circumferential connectors and the axial connectors are positioned between the ovals coincident with the common short and long axes of the ovals, respectively.

7. The expandable vascular stent of claim 5, further comprising prongs extending from at least some of the circumferential connectors between ovals in rows 1 and n.

8. The expandable vascular stent of claim 1, wherein on continued expansion at a desired location within a patient, due to foreshortening of the ovals tissue is engaged in between the prongs so as to form a stable connection of the stent to tissue at the desired location.

9. The expandable vascular stent of claim 8, wherein the prongs exert a generally longitudinally-directed force on the tissue engaged therebetween.

10. The expandable vascular stent of claim 1, wherein the cylinder and the prongs are made of surgical stainless steel and the cylinder is expanded using an angioplasty balloon.

11. The expandable vascular stent of claim 1, wherein the cylinder and the prongs are made of a memory metal and the cylinder is self-expanding.

12. The expandable vascular stent of claim 1, further comprising a percutaneous heart valve seated inside the cylinder.

13. An expandable vascular stent comprising:

an m×

n array of ovals formed in a cylinder having a diameter, a circumference, an axis, and a length in the direction of the axis, where m is the number of columns of ovals in the circumferential direction and n is the number of rows of ovals in the axial direction, the ovals having a short axis and a long axis, the short axis of the ovals extending in the circumferential direction and the long axis of the ovals extending in the axial direction, the cylinder being expandable from an initial diameter to a pre-determined final diameter, wherein an increase in the diameter of the stent results in a decrease in the length of the stent; and

a plurality of prongs located at rows 1 and n of the m×

n array for connecting the cylinder to a surrounding body, a first plurality of prongs located at row 1 extending generally radially outwardly from the ovals and generally toward a second plurality of prongs located at row n, and the second plurality of prongs located at row n extend generally radially outwardly from the ovals and generally toward the first plurality of prongs at row 1;

wherein each prong includes a spine extending the length of the long axis of the oval and a furcation on either side of the spine at a location between the ends of the spine.

14. The expandable vascular stent of claim 13, wherein the spine has end hinge points at the ends thereof and an intermediate hinge point at the base of the furcations, and wherein an amount by which the ovals are foreshortened and an angle of the furcations upon expansion depends on the location of the intermediate hinge point relative to the end hinge points.

15. A support for a vascular prosthesis, comprising:

at least one row of interconnected foreshortening cells extending circumferentially around a longitudinal axis of the support, each of the foreshortening cells having a circumferential axis in the circumferential direction and a long axis in the longitudinal direction, each foreshortening cell having a proximal end and a distal end, the support being expandable from a compacted diameter to an expanded diameter, the foreshortening cells being configured so that when the support is expanded from the compacted diameter to the expanded diameter, the circumferential axis of each foreshortening cell increases while simultaneously the long axis of each foreshortening cell decreases;

a plurality of elongate distal prongs extending from the distal ends of foreshortening cells in one of the at least one row of interconnected foreshortening cells, the elongate distal prongs extend generally radially outwardly from the foreshortening cells and generally axially toward the proximal end of the associated foreshortening cells, each distal prong having a first and a second portion along its length, the prong being bent between the first and second portions so that the second portion extends in a more axially-directed direction than the first portion; and

a plurality of elongate proximal prongs extending from the proximal ends of foreshortening cells in one of the at least one row of interconnected foreshortening cells, the elongate proximal prongs extending generally radially outwardly from the foreshortening cells and generally axially toward the distal end of the associated foreshortening cells so that a space is defined between tips of the proximal and distal prongs, each proximal prong having a first and a second portion along its length, the prong being bent between the first and second portions so that the second portion extends in a more axially-directed direction than the first portion;

wherein when the support is radially expanded a longitudinal distance between the tips of the proximal and distal prongs decreases.

16. The support of claim 15, wherein the foreshortening cells are defined by a plurality of interconnected struts.

17. The support of claims 15, wherein when the support is expanded in diameter a shape of each foreshortening cell changes.

18. The support of claim 17, wherein at a first stent diameter a first one of the foreshortening cells is oval-shaped, and at a second stent diameter the first foreshortening cell is diamond-shaped.

19. The support of claim 15, wherein the support comprises a plurality of rows of interconnected foreshortening cells, and the proximal prongs extend from a different row of interconnected foreshortening cells than do the distal prongs.

20. The support of claims 15, wherein in the expanded configuration, the second portion of each of the distal and proximal prongs is substantially straight, and the substantially straight second portion of one of the proximal prongs is generally collinear with the substantially straight second portion of one of the distal prongs.

21. The support of claims 20, wherein in the expanded configuration the substantially straight second portion of one of the proximal prongs is generally parallel to the substantially straight second portion of another of the proximal prongs.

22. The support of claims 21, wherein in the expanded configuration the substantially straight second portion of one of the proximal prongs is generally parallel to the substantially straight second portion of at least one of the distal prongs.

23. The support of claim 15, further comprising a percutaneous heart valve seated inside the support.

24. The support of claim 15, wherein the prongs are configured so that when the support is expanded from the compacted diameter to the expanded diameter so that the longitudinal distance between the tips of the proximal and distal prongs decreases, body tissue in the space between the tips of the proximal and distal prongs is engaged by the prongs sufficient to form a stable connection between the support and the tissue.

25. The support of claim 24, wherein the tips of the prongs exert a generally longitudinally-directed force on the tissue engaged therebetween.

26. The support of claim 25 in combination with an expandable balloon, wherein the support is made of surgical stainless steel and is expandable using the balloon.

27. The support of claim 25, wherein the support is made of a memory metal and is configured to self-expand toward the expanded diameter.

28. A support for a vascular prosthesis, comprising:

at least one row of interconnected foreshortening cells extending circumferentially around a longitudinal axis of the support, each of the foreshortening cells having a circumferential axis in the circumferential direction and a long axis in the longitudinal direction, the support having a proximal end and a distal end and being expandable from a compacted diameter to an expanded diameter, the foreshortening cells being configured so that when the support is expanded from the compacted diameter to the expanded diameter, the circumferential axis of each foreshortening cell increases while simultaneously the long axis of each foreshortening cell decreases;

an elongate distal prong extending from a foreshortening cell in one of the at least one row of interconnected foreshortening cells, the elongate distal prong extending generally radially outwardly from the foreshortening cell and generally axially toward the proximal end of the support; and

an elongate proximal prong extending from the support proximal of the distal prong, the elongate proximal prong extending generally radially outwardly relative to the foreshortening cells of the support and generally axially toward the distal end of the support so that a space is defined between tips of the proximal and distal prongs and the distal prong tip is distal of the proximal prong tip;

wherein the prongs are bent when the support is radially expanded so that a first portion of each prong, which first portion is spaced from the prong tip, extends outwardly relative to the longitudinal axis of the support, and the prongs are further bent so that a second portion of the prong adjacent the prong tip extends inwardly relative to the outwardly-bent first portion; and

wherein when the support is radially expanded a longitudinal distance between the tips of the proximal and distal prongs decreases.

29. The support of claim 28, wherein the prongs are configured so that when the support is expanded from the compacted diameter to the expanded diameter so that the longitudinal distance between the tips of the proximal and distal prongs decreases, body tissue in the space between the tips of the proximal and distal prongs is engaged by the prongs sufficient to form a stable connection between the support and the tissue.

30. The support of claim 29, wherein the prongs exert a generally longitudinally-directed force on the tissue engaged therebetween.

31. The support of claim 30 additionally comprising a percutaneous replacement heart valve attached inside the support, and the support is sized and configured so that the prongs axially engage tissue as the support is radially expanded so as to anchor the support within a native heart valve opening.

32. The support of claims 31, wherein in the expanded configuration the distal and proximal prongs each comprise a substantially straight portion, and the straight portions are generally parallel to the longitudinal axis of the support.

33. The support of claim 32, wherein the support is made of a memory metal material, and is configured to self-expand from the compacted diameter toward the expanded diameter, and wherein a memory shape of the prongs is to comprise a base portion that bends radially outwardly relative to the corresponding foreshortening cell, and an elongate portion that extends generally straight and parallel to the longitudinal axis of the support.

34. The support of claim 33, wherein the proximal and distal prongs extend longitudinally toward one another when the support is in the compacted diameter.

35. The support of claim 28, wherein the elongate proximal prong extends from a foreshortening cell in one of the at least one row of interconnected foreshortening cells.

36. A support for a vascular prosthesis, comprising:

a support body comprising an array of interconnected cells extending circumferentially around a longitudinal axis of the support, the support body having a proximal end and a distal end and being radially expandable from a compacted state to an expanded state;

an elongate distal prong extending from the support body, the elongate distal prong extending generally toward the proximal end of the support body so that a tip of the distal prong is longitudinally proximal of a base of the distal prong;

an elongate proximal prong extending from the support body, the elongate proximal prong extending generally toward the distal end of the support body so that a tip of the proximal prong is longitudinally distal of a base of the proximal prong and the tip of the proximal prong is proximal of the tip of the distal prong;

the prongs bent when in the expanded state so that a first portion of each prong adjacent the prongs base is bent outwardly relative to the longitudinal axis of the support and the prongs are further bent so that a second portion of the prong adjacent the prong tip is directed inwardly relative to the outwardly-bent first portion;

the support body comprising a foreshortening portion between at least the tips of the distal and proximal prongs, the foreshortening portion configured to longitudinally shorten as the support body is radially expanded from the compacted state to the expanded state;

wherein when the support body is radially expanded from the compacted state to the expanded state a longitudinal distance between the tips of the proximal and distal prongs decreases; and

wherein when the support body is in the expanded state the distal prong extends generally radially outwardly from the support body and toward the proximal end of the support body, and the proximal prong extends generally radially outwardly from the support body and toward the distal end of the support body.

37. The support of claim 36, wherein the interconnected cells in the foreshortening portion are each defined by a plurality of interconnected struts, and wherein when the support body is radially expanded a shape of each cell in the foreshortening portion changes.

38. The support of claim 37, wherein when the support body is in the compacted state the cells in the foreshortening portion are generally oval-shaped, and when the support body is in the expanded state the cells in the foreshortening portion are generally diamond-shaped.

39. The support of claim 36, wherein the prongs are configured so that when the support body is radially expanded from the compacted state to the expanded state so that the longitudinal distance between the tips of the proximal and distal prongs decreases, body tissue in a space between the tips of the proximal and distal prongs is engaged by the prongs sufficient to form a stable connection between the support and the tissue.

40. The support of claim 39, wherein the prongs exert a generally longitudinally-directed force on the tissue engaged therebetween.

41. The support of claim 40 additionally comprising a percutaneous replacement heart valve attached inside the support body, and the support is sized and configured so that the prongs axially engage tissue as the support is radially expanded so as to anchor the support within a native heart valve opening.

42. The support of claims 41, wherein in the expanded state the second portions of the prongs are substantially straight and generally parallel to the longitudinal axis of the support.

43. The support of claim 42, wherein in the expanded state the first portions of the prongs are substantially straight, and a second bend point is defined between the first and second portions.

44. The support of claim 36, wherein the elongate distal prong extends from one of the cells in the foreshortening portion.

45. The support of claim 44, wherein the elongate proximal prong extends from one of the cells in the foreshortening portion.