Implant delivery device

• US 8,652,193 B2
• Filed: 05/05/2006
• Issued: 02/18/2014
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Angiomed GmbH & Co. Medizintechnik KG
• Original Assignee: Angiomed GmbH & Co. Medizintechnik KG
• Inventors: Dorn, Jurgen
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/914,094
• Publication Number:
  US 20080234796A1
• Time in Patent Office: 2,846 Days
• Field of Search: 606/151, 606/191, 623/1.11
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell

Abstract

An implant delivery device preferably includes a first shaft having a proximal portion and a distal portion. The first shaft includes an outer surface and an inner surface defining a first lumen along a longitudinal axis. The distal portion includes a tip defining a taper in the distal direction toward the longitudinal axis and terminating at a distal opening. The device also includes a second shaft having a proximal portion and a distal portion and an inner surface defining a second lumen therebetween having a first cross-section. The second shaft is disposed within the first lumen such that the second lumen is generally coaxial with the first lumen to define a chamber. The distal portion of the second shaft terminates in a port having an opening in communication with the distal opening of the first shaft. The port preferably includes a second cross-section greater than the first cross-section.

Claims

1. An implant delivery device comprising:

a first shaft having a proximal portion and a distal portion, the first shaft having an outer surface and an inner surface defining a first lumen along a longitudinal axis, the distal portion having a tip defining a taper in the distal direction toward the longitudinal axis and terminating at a distal opening;

a second shaft having a proximal portion and a distal portion and an inner surface defining a second lumen therebetween having a first cross-section, the second shaft disposed within the first lumen such that the second lumen is generally coaxial with the first lumen to define a chamber, the distal portion of the second shaft terminating in a port having an opening in communication with the distal opening of the first shaft, the opening of the port having a second cross-section greater than the first cross-section.

2. The implant delivery device of claim 1, wherein the port includes a flared portion extending in a distal direction toward the inner surface of the first shaft.

3. The implant delivery device of claim 2, wherein the port includes a portion distal of the flared portion that is parallel to the longitudinal axis.

4. The implant delivery device of claim 2, wherein the distal portion circumscribes the longitudinal axis such that at least a portion of the port is substantially frusto-conical.

5. The implant delivery device of claim 2, wherein the flared portion circumscribes the longitudinal axis such that at least a portion of the port is substantially tulip-shaped.

6. The implant delivery device of claim 1, further comprising an inner shaft having a proximal portion, a distal portion, an outer surface and an inner surface defining a lumen, the inner shaft disposed in the lumen of the second shaft such that distal portion of the second shaft directs a guide wire from the distal opening of the first shaft to the lumen of the inner shaft.

7. The implant delivery device of claim 6, wherein the outer surface of the inner shaft is substantially contiguous with the inner surface of the second shaft along a substantial length of the second shaft.

8. The implant delivery device of claim 6, wherein the second shaft is coupled to the inner shaft such that the second shaft is slidable along the longitudinal axis relative to the first shaft.

9. The implant delivery device of claim 6, wherein the proximal portion of the second shaft terminates along a portion of the inner shaft between the distal and proximal portion of the inner shaft.

10. The implant delivery device of claim 6, wherein the outer surface of the inner shaft defines a maximum distance transverse to the longitudinal axis and the inner surface of the second shaft defines a maximum distance transverse to the longitudinal axis, the maximum transverse distance of the second shaft being about ten percent greater than the maximum transverse distance of the inner shaft.

11. The implant delivery device of claim 1, wherein the outer surface and the inner surface of the tip define a wall.

12. The implant delivery device of claim 11, wherein the wall has a thickness that decreases in a direction along the longitudinal axis from the proximal portion to the distal opening.

13. The implant delivery device of claim 12, wherein the wall thickness decreases from a maximum of about 0.2 millimeters to a minimum of about 0.1 millimeters.

14. The implant delivery device of claim 13, wherein the thickness decreases at a substantially constant rate over the axial length of the tip.

15. The implant delivery device of claim 1, wherein the taper of the tip defines an acute angle with a line parallel to the longitudinal axis, the angle ranging from about eight degrees to about twenty degrees.

16. The implant delivery device of claim 1, wherein the distal portion of the first shaft includes at least one radiopaque marker for identifying the position of an implant in the chamber.

17. The implant delivery device of claim 16, wherein the at least one marker comprises an annular member secured to the first shaft having about ninety percent platinum and about ten percent iridium.

18. The implant delivery device of claim 1, wherein the outer and inner surface of the first shaft proximal the tip define a wall thickness that increases in a direction from the distal portion to the proximal portion, ranging from about 0.2 millimeters to about 0.3 millimeters.

19. The implant delivery device of claim 1, wherein the tip is substantially made of PEBAX®

having a durometer of about 40D.

20. The implant delivery device of claim 1, wherein the first shaft has at least two slits, the at least two slits extending axially along the length of the tip diametrically opposite one another about the distal opening.

21. The implant delivery device of claim 1, wherein the port includes an aperture to provide communication between the tip and the lumen of the second shaft.

22. An implant delivery device comprising:

an inner shaft having a first diameter extending between a proximal end and a distal end spaced apart along a longitudinal axis, the inner shaft terminating in a port having a second diameter greater than the first diameter; and

an outer sheath disposed about the inner shaft, the outer sheath terminating in a distal tip tapering toward the longitudinal axis, the outer sheath being movable along the longitudinal axis in a proximal direction relative to the inner shaft to expose the port, the outer sheath having a layer including a proximal portion, a distal portion, and at least one intermediate portion therebetween, the proximal, distal and at least one intermediate portions being discrete portions along the longitudinal axis, each having a discrete durometer.

23. The implant delivery device of claim 22, wherein the distal portion comprises a thermoplastic polymer, the proximal portion comprises polyamide Nylon and the at least one intermediate portion being one of PEBAX®

6333 and PEBAX®

7233.

24. The implant delivery device of claim 22, wherein the durometers of the discrete portions increase from the distal portion to the proximal portion.

25. An implant delivery device comprising:

an inner shaft having a proximal end and a distal end spaced apart along a longitudinal axis; and

an outer sheath having a proximal portion, a distal portion and at least one intermediate portion therebetween, the outer sheath being disposed about the inner shaft, the outer sheath being movable along the longitudinal axis relative to the inner shaft;

the outer sheath having an outer layer of a first polymer, an inner layer of a second polymer having a durometer greater than that of the first polymer, an intermediate layer of at least a third polymer disposed between the first and second polymer, and a braiding disposed between a portion of the inner and outer layer, the intermediate layer joining the braid to the first and second polymer.

26. The implant delivery device of claim 25, wherein the first and second polymer are PEBAX®

and the third polymer comprises PET.

27. The implant delivery device of claim 25, wherein the first polymer is disposed between the distal portion and the at least one intermediate portion.

28. The implant delivery device of claim 25, wherein the first polymer includes at least one shoulder, the second polymer engaging the shoulder to join the first polymer to the second polymer.

29. The implant delivery device of claim 25, wherein the braiding comprises a metallic wire having a diameter of about 0.05 millimeters at a density of 45 crossings per linear inch.

30. The implant delivery device of claim 25, wherein at least a portion of the third polymer is surrounded by a heat melted polymer.

31. The implant delivery device of claim 25, further comprising at least one marker disposed about 1.5 millimeters from a terminal end of the braiding so that the marker abuts the third polymer.

32. The implant delivery device of claim 31, wherein the marker is about one millimeter in length.

33. The implant delivery device of claim 25, wherein the outer layer of the outer sheath includes a fourth polymer coupled to the second polymer, and a fifth polymer joined to the fourth polymer, the fifth polymer being Nylon 75D.

34. The implant delivery device of claim 33, wherein the second polymer has an axial length greater than ten millimeters, the second and fourth polymers extending in the axial direction over a length of at least eighty millimeters.

35. The implant delivery device of claim 33, wherein the second and fifth polymers extending in the axial direction over a length of at least twenty millimeters.

36. The implant delivery device of claim 33, wherein the fourth polymer has a higher durometer than either of the first or third polymers.

37. The implant delivery device of claim 25, wherein the outer layer of the outer sheath includes a proximal portion, a distal portion, and at least one intermediate portion extending therebetween, the distal portion being a thermoplastic polymer, the proximal portion being a polyamide Nylon, and the intermediate portion being one of PEBAX®

6333 and PEBAX®

7233.

38. The implant delivery device of claim 37, wherein the proximal, distal and at least one intermediate portions of the outer layer of the outer sheath are discrete portions each having a discrete durometer.

39. A catheter sheath comprising:

a first polymer material that circumscribes and extends along a longitudinal axis over a first length;

a second polymer contiguous to the first polymer that extends along the longitudinal axis along a second length less than the first and having a surface exposed to the longitudinal axis;

a third polymer interposed between the first and second polymer that extends along the longitudinal axis along a third length less than the first length; and

a marker contiguous to one of the first and second polymers.

40. The catheter sheath of claim 39, wherein the marker comprises a marker disposed between the first and second polymers.

41. The catheter of claim 40, wherein the marker comprises a radiopaque material contiguous to the first, second and third polymers.

42. The catheter sheath of claim 39, further comprising a braiding disposed between the second and third polymer.

43. The catheter sheath of claim 42, wherein the braiding comprises metal wires braided in a cylindrical shape.

44. A catheter sheath comprising:

a proximal portion, a distal portion and at least one intermediate portion therebetween, the sheath having an outer layer of a first polymer circumferentially surrounding an inner layer of a second polymer having a durometer greater that of the first polymer and an intermediate layer of at least a third polymer disposed between the first and second polymer.

45. The sheath of claim 44, wherein the first and second polymer are PEBAX®

and the third polymer comprises PET.

46. The sheath of claim 44, wherein the first polymer is disposed between the distal portion and the at least one intermediate portion.

47. The sheath of claim 44, wherein the first polymer includes at least one shoulder, the second polymer engaging the shoulder to join the first polymer to the second polymer.

48. The sheath of claim 44, further comprising a braiding disposed between the inner layer and the outer layer, wherein the braiding is made of a metallic wire having a diameter of about 0.05 millimeters at a density of 45 crossings per linear inch.

49. The sheath of claim 48, wherein the third polymer joins the braiding to the first and second polymers.

50. The sheath of claim 48, further comprising at least one marker disposed about 1.5 millimeters from a terminal end of the braiding so that the marker abuts the third polymer.

51. The sheath of claim 50, wherein the marker is about one millimeter in length.

52. The sheath of claim 44, wherein at least a portion of the third polymer is surrounded by a heat melted polymer.

53. The sheath of claim 44, wherein the outer layer of the outer sheath includes a fourth polymer coupled to the second polymer, and a fifth polymer joined to the fourth polymer, the fifth polymer being Nylon 75D.

54. The sheath of claim 53, wherein the second polymer has an axial length greater than ten millimeters, the second and fourth polymers extend in the axial direction over a length of at least eighty millimeters.

55. The sheath of claim 53, wherein the second and fifth polymers extend in the axial direction over a length of at least twenty millimeters.

56. The sheath of claim 53, wherein the fourth polymer has a higher durometer than either of the first or third polymers.

57. The sheath of claim 44, wherein the outer layer of the outer sheath includes a proximal portion, a distal portion, and at least one intermediate portion extending in between, the distal portion being made of a thermoplastic polymer, the proximal portion polyamide Nylon, the intermediate portion being one of PEBAX®

6333 and PEBAX®

7233.

58. The sheath of claim 57, wherein the proximal, distal and at least one intermediate portions of the outer layer of the outer sheath are discrete portions each having a discrete durometer.