Medical device

• US 9,585,668 B2
• Filed: 12/13/2004
• Issued: 03/07/2017
• Est. Priority Date: 03/31/2004
• Status: Expired due to Fees

• Current Assignee: Merlin MD Pte. Ltd.
• Original Assignee: Merlin MD Pte. Ltd.
• Inventors: Rudakov, Leon, O'Connor, Michael, Gandhi, Deepak
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US10/580,139
• Publication Number:
  US 20070100430A1
• Time in Patent Office: 4,467 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.2, 623/135, 623 138- 14, 623/1.42, 623 144- 146, 623/1.49
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• 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 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2250/0037 : differing in height or in length
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A medical device for insertion into a bodily vessel to treat an aneurysm (201), the device comprising: a mechanically expandable device (202) expandable from a first position to a second position, said mechanically expandable device (202) is expanded radially outwardly to the second position such that the exterior surface of said mechanically expandable (202) engages with the inner surface of the vessel so as to maintain a fluid pathway through said vessel; and a membrane (203) expandable from a first position to a second position in response to expansion of said mechanically expandable device (202), said membrane (203) obstructing blood circulation to the aneurysm (201) when expanded to the second position, and at least a portion of the membrane (203) is secured to the mechanically expandable device (202) to maintain the position of the membrane (203) relative to the mechanically expandable device (202) when expanded to the second position.

Claims

1. A medical device for insertion into a bodily vessel to treat an intracranial aneurysm, the device comprising:

a mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the mechanically expandable device engages with an inner surface of the vessel so as to maintain a fluid pathway through the vessel, the mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects three axially adjacent circumferential rings, such that at least one of the first longitudinal struts is circumferentially adjacent to at least one of the second longitudinal struts, wherein the mechanically expandable device comprises a region bounded by a pair of boundary lines extending only longitudinally from a proximal end of the mechanically expandable device to a distal end of the mechanically expandable device, wherein a total number of the first longitudinal struts in the region exceeds a total number of the second longitudinal struts in the region; and

a porous membrane, expandable in response to expansion of the mechanically expandable device;

wherein at least a portion of the membrane is secured to the mechanically expandable device, such that a proximal end of the membrane is proximate to the proximal end of the mechanically expandable device, and a distal end of the membrane is proximate to the distal end of the mechanically expandable device; and

wherein the membrane has a substantially uniform porosity over a length extending from the distal end of the membrane to the proximal end of the membrane, the membrane having pores with a size between about 20 microns and about 100 microns and a distance between adjacent pores of the membrane being less than 75 microns, the membrane having a width that is less than 0.001 inches; and

wherein, when the mechanically expandable device is expanded in the bodily vessel, adjacent to the aneurysm, the membrane is configured to;

(i) obstruct blood flow from the vessel into the aneurysm such that blood flow into the aneurysm is reduced; and

(ii) permit blood flow through pores in the membrane and into branch vessels arising from the bodily vessel so as not to inhibit blood supply functions of perforator vessels.

2. The medical device of claim 1, wherein a distance between adjacent pores is greater than about 40 microns.

3. The medical device of claim 1, wherein the membrane is made of a biocompatible and elastomeric polymer.

4. The medical device of claim 1, wherein a ratio of a material surface area of the membrane is from about 25 to 75%.

5. The medical device of claim 1, wherein the membrane is made from a polymeric material or a biodegradable material.

6. The medical device of claim 5, wherein the polymeric material or the biodegradable material forms multiple sub-layers mixed with drugs or reagents.

7. The medical device of claim 6, wherein the at least one drug or reagent is in a form selected from the group consisting of a solid tablet, a liquid, and a powder.

8. The medical device of claim 1, wherein the membrane isotropically expands.

9. The medical device of claim 1, wherein the membrane is disposed on an exterior surface of the mechanically expandable device.

10. The medical device of claim 1, wherein the membrane completely covers the exterior surface of the mechanically expandable device.

11. The medical device of claim 1, wherein the membrane circumferentially surrounds a portion of the mechanically expandable device.

12. The medical device of claim 1, wherein the membrane covers a portion of the mechanically expandable device.

13. The medical device of claim 1, wherein the membrane is made from a solid polymer.

14. The medical device of claim 1, wherein the pores are fabricated.

15. The medical device of claim 14, wherein the pores are fabricated by laser drilling.

16. The medical device of claim 1, wherein the membrane comprises a plurality of polymeric strips secured to the mechanically expandable device.

17. The medical device of claim 16, wherein the strips are less than 0.075 mm wide.

18. The medical device of claim 1, wherein the membrane comprises a mesh secured to the mechanically expandable device.

19. The medical device of claim 18, wherein an interstitial spacing of the mesh is less than 100 μ

m and a width of the meshing is between 0.025 to 0.050 mm.

20. The medical device of claim 1, wherein the mechanically expandable device comprises a generally tubular structure having an exterior surface defined by the plurality of circumferential rings having interstitial spaces therebetween.

21. The medical device of claim 20, wherein the membrane is supported by the generally tubular structure and is attached to at least one circumferential rings of the mechanically expandable device.

22. A method of making the medical device of claim 20, the method comprising:

disposing the first mechanically expandable device on a mandrel; and

incorporating the membrane between circumferential rings of the first mechanically expandable device.

23. The medical device of claim 1, wherein the mechanically expandable device is self-expandable or balloon expandable.

24. The medical device of claim 1, wherein the mechanically expandable device comprises a stent.

25. The medical device of claim 24, wherein the membrane is tubular;

and wherein the membrane is disposed onto the outer surface of the stent or introduced by dip coating or spraying between the circumferential rings of the stent.

26. The medical device of claim 24, wherein the membrane is a segment of a tubular structure disposed onto a portion of an outer surface of the stent.

27. The medical device of claim 1, wherein at least one radiopaque marker is provided on the mechanically expandable device.

28. The medical device of claim 27, wherein the at least one radiopaque marker comprises gold or platinum.

29. The medical device of claim 27, wherein center radiopaque markers and end radiopaque markers are provided on the mechanically expandable device.

30. A method of making the medical device of claim 1, the method comprising:

disposing the first mechanically expandable device on a mandrel; and

disposing the membrane onto an outer surface of the first mechanically expandable device.

31. A medical device for treating a bifurcation or trifurcation intracranial aneurysm between at least two bodily vessels, the device comprising:

a first mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the first mechanically expandable device is configured to engage an inner surface of a first branch vessel arising from a parent vessel so as to maintain a fluid pathway through the first branch vessel, the first mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects three axially adjacent circumferential rings, wherein each of the plurality of first longitudinal struts is straight along an entire length thereof, wherein the first mechanically expandable device comprises a region bounded by a pair of boundary lines extending only longitudinally from a proximal end of the first mechanically expandable device to a distal end of the first mechanically expandable device, wherein a total number of the first longitudinal struts in the region exceeds a total number of the second longitudinal struts in the region;

a second mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the second mechanically expandable device is configured to engage an inner surface of a second branch vessel arising from the parent vessel so as to maintain a fluid pathway through the second branch vessel; and

a porous membrane, at least a portion of a proximate end of the membrane is secured to the first mechanically expandable device and a distal end of the membrane is secured to the second mechanically expandable device;

wherein the membrane has a substantially uniform porosity over a length extending from the distal end of the membrane to the proximal end of the membrane and a distance between adjacent pores of the membrane being less than 75 microns, the membrane having a thickness that is less than 0.001 inches and a durometer of 75 A Shore; and

wherein, when the first mechanically expandable device is expanded in the first branch vessel adjacent to the aneurysm and the second mechanically expandable device is expanded in the second branch vessel adjacent to the aneurysm, the membrane;

(i) obstructs blood flow into the aneurysm such that blood flow into the aneurysm is reduced; and

(ii) permits blood flow through pores in the membrane and into perforators and/or microscopic branches of brain arteries so as not to inhibit blood supply functions of perforator vessels.

32. The medical device of claim 31, wherein the membrane expands in response to expansion of the first mechanically expandable device.

33. The medical device of claim 31, wherein the membrane expands in response to expansion of the first and second mechanically expandable devices.

34. A medical device for insertion into a bodily vessel to treat an intracranial aneurysm, the device comprising:

a mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the mechanically expandable device engages an inner surface of the vessel so as to maintain a fluid pathway through the vessel, the mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects three axially adjacent circumferential rings, such that an axially adjacent pair of circumferential rings are connected only by one of the second longitudinal struts, wherein each of the plurality of second longitudinal struts is straight along an entire length thereof, wherein the mechanically expandable device comprises a region bounded by a pair of boundary lines extending parallel to a central axis of the mechanically expandable device from a proximal end of the mechanically expandable device to a distal end of the mechanically expandable device, wherein a total number of the first longitudinal struts in the region exceeds a total number of the second longitudinal struts in the region; and

a porous membrane, expandable in response to expansion of the mechanically expandable device;

wherein at least a portion of the membrane is secured to the mechanically expandable device, such that a proximal end of the membrane is proximate to the proximal end of the mechanically expandable device, and a distal end of the membrane is proximate to the distal end of the mechanically expandable device; and

wherein the membrane has a substantially uniform porosity over a length extending from the distal end of the membrane to the proximal end of the membrane and a distance between adjacent pores of the membrane being less than 75 microns, the membrane having a thickness that is less than 0.001 inches and having a tensile strength of 7500 psi; and

wherein, when the mechanically expandable device is expanded in the bodily vessel, adjacent to the aneurysm, the membrane;

(i) obstructs blood flow from the vessel into the aneurysm such that blood flow into the aneurysm reduced; and

(ii) permits blood flow through pores in the membrane and into branch vessels arising from the bodily vessel so as not to inhibit blood supply functions of perforator vessels.

35. The medical device of claim 34, wherein a distance between adjacent pores is greater than about 40 microns.

36. The medical device of claim 34, wherein the membrane is made of a biocompatible and elastomeric polymer.

37. The medical device of claim 34, wherein a ratio of a material surface area of the membrane is from about 25 to 75%.

38. The medical device of claim 34, wherein the membrane is made from a polymeric material or a biodegradable material.

39. The medical device of claim 38, wherein the polymeric material or the biodegradable material forms multiple sub-layers mixed with drugs or reagents.

40. The medical device of claim 39, wherein the at least one drug or reagent is in a form selected from the group consisting of a solid tablet, a liquid, and a powder.

41. The medical device of claim 34, wherein the membrane is capable of isotropic expansion.

42. The medical device of claim 34, wherein the membrane is disposed on an exterior surface of the mechanically expandable device.

43. The medical device of claim 34, wherein the membrane completely surrounds the mechanically expandable device.

44. The medical device of claim 34, wherein the membrane circumferentially surrounds a portion of the mechanically expandable device.

45. The medical device of claim 34, wherein the membrane covers a portion of the mechanically expandable device.

46. The medical device of claim 34, wherein the membrane is made from a solid polymer.

47. The medical device of claim 34, wherein the pores are fabricated.

48. The medical device of claim 47, wherein the pores are fabricated by laser drilling.

49. The medical device of claim 34, wherein the membrane comprises a plurality of polymeric strips secured to the mechanically expandable device.

50. The medical device of claim 49, wherein the strips are less than 0.075 mm and a distance between adjacent strips is less than 100 μ

m.

51. The medical device of claim 34, wherein the membrane comprises a mesh secured to the mechanically expandable device.

52. The medical device of claim 51, wherein a spacing of the mesh is less than 100 μ

m and a width of the meshing is between 0.025 to 0.050 mm.

53. The medical device of claim 34, wherein the mechanically expandable device comprises a generally tubular structure having an exterior surface defined by a plurality of interconnected circumferential rings having interstitial spaces therebetween.

54. The medical device of claim 53, wherein the membrane is supported by the generally tubular structure and is attached to at least one circumferential ring.

55. The medical device of claim 54, wherein the membrane is tubular;

and wherein the membrane is disposed onto the outer surface of the stent or introduced by dip coating or spraying between the circumferential rings of the stent.

56. The medical device of claim 55, wherein the membrane is a segment of a tubular structure disposed onto a portion of an outer surface of the stent.

57. The medical device of claim 34, wherein the mechanically expandable device is self-expandable or balloon expandable.

58. The medical device of claim 34, wherein the mechanically expandable device comprises a stent.

59. The medical device of claim 34, wherein at least one radiopaque marker is provided on the mechanically expandable device.

60. The medical device of claim 59, wherein the at least one radiopaque marker comprises gold or platinum.

61. The medical device of claim 59, wherein center radiopaque markers and end radiopaque markers are provided on the mechanically expandable device.

62. A method of making the medical device of claim 34, the method comprising:

disposing the mechanically expandable device on a mandrel; and

disposing the membrane onto an outer surface of the mechanically expandable device.

63. A medical device for treating a bifurcation or trifurcation intracranial aneurysm between at least two bodily vessels, the device comprising:

a first mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the first mechanically expandable device engages an inner surface of a first branch vessel arising from a parent vessel so as to maintain a fluid pathway through the first branch vessel, the mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects only three axially adjacent circumferential rings, such that at least one of the first longitudinal struts is circumferentially adjacent to at least one of the second longitudinal struts, wherein at least some longitudinally adjacent pairs of the first longitudinal struts are not separated longitudinally by one of the second longitudinal struts;

a second mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the second mechanically expandable device engages an inner surface of a second branch vessel arising from the parent vessel so as to maintain a fluid pathway through the second branch vessel; and

a porous membrane, at least a portion of a proximate end of the membrane is secured to the first mechanically expandable device and a distal end of the membrane is secured to the second mechanically expandable device;

wherein the membrane has a substantially uniform porosity over a length extending from the distal end of the membrane to the proximal end of the membrane, and comprises pores with a size between about 20 microns and about 100 microns and a distance between adjacent pores of the membrane being less than 75 microns, a thickness of the membrane being less than 0.001 inches; and

wherein, when the first mechanically expandable device is expanded in the first branch vessel adjacent to the aneurysm and the second mechanically expandable device is expanded in the second branch vessel adjacent to the aneurysm, the membrane;

(i) obstructs blood flow into the aneurysm such that blood flow into the aneurysm is reduced; and

(ii) permits blood flow through pores in the membrane and into perforators and/or microscopic branches of brain arteries so as not to inhibit blood supply functions of perforators vessels.

64. A method of making the medical device of claim 63, the method comprising:

disposing the mechanically expandable device on a mandrel; and

incorporating the membrane between circumferential rings of the mechanically expandable device.

65. The medical device of claim 63, wherein the membrane expands in response to expansion of the first mechanically expandable device.

66. The medical device of claim 63, wherein the membrane expands in response to expansion of the first and second mechanically expandable devices.

67. A medical device for insertion into a bodily vessel to treat an intracranial aneurysm, the device comprising:

a mechanically expandable device, expandable from a contracted position to an expanded position such that, in the expanded position, an exterior surface of the mechanically expandable device engages an inner surface of the vessel, the mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects three axially adjacent circumferential rings, wherein each of the second longitudinal struts comprises a radiopaque marker forming a ring, wherein at least some longitudinally adjacent pairs of the first longitudinal struts are not separated longitudinally by one of the second longitudinal struts; and

a porous membrane, with a thickness that is less than 0.001 inches, expandable in response to expansion of the mechanically expandable device, the porous membrane;

(i) having a substantially uniform porosity over a length extending from a distal end of the membrane to a proximal end of the membrane and a distance between adjacent pores of the membrane being less than 75 microns;

(ii) being secured to the mechanically expandable device, such that the proximal end of the membrane is proximate a proximal end of the mechanically expandable device, and the distal end of the membrane is proximate a distal end of the mechanically expandable device; and

(iii) being configured to, when expanded in the bodily vessel adjacent the aneurysm, reduce blood flow from the vessel into the aneurysm and permit blood supply to perforator vessels through pores of the membrane along the length of the membrane so as not to inhibit blood supply functions of perforator vessels.

68. A medical device for insertion into a bodily vessel to treat an intracranial aneurysm, the device comprising:

a mechanically expandable device, expandable from a first position to a second position such that, in the second position, an exterior surface of the mechanically expandable device is sized and configured to engage an inner surface of the vessel so as to maintain a fluid pathway through the vessel, the mechanically expandable device comprising a plurality of circumferential rings, a plurality of first longitudinal struts, and a plurality of second longitudinal struts, wherein each of the first longitudinal struts connects only two axially adjacent circumferential rings, and wherein each of the second longitudinal struts connects three axially adjacent circumferential rings, wherein each of the second longitudinal struts comprises a radiopaque marker forming a ring, wherein at least some longitudinally adjacent pairs of the first longitudinal struts are not separated longitudinally by one of the second longitudinal struts; and

a porous membrane, secured to the mechanically expandable device, having a substantially uniform porosity, the membrane, having a thickness that is less than 0.001 inches, being expandable in response to expansion of the mechanically expandable device and, when the mechanically expandable device is in the second position, the membrane comprising pores with a size between about 20 microns and about 100 microns and a distance between adjacent pores of the membrane being less than 75 microns, such that the membrane reduces blood flow from the vessel into the aneurysm and permits blood supply to small branch vessels, branching from the vessel, through pores of the membrane so as not to inhibit blood supply functions of the small branch vessels.