Lead locking device and method

• US 20030036788A1
• Filed: 08/20/2001
• Published: 02/20/2003
• Est. Priority Date: 12/04/2000
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Plasket, Thomas E., Coe, Michael Sean, Harlan, Kenneth D.
• Granted Patent: US 6,772,014 B2
• Time in Patent Office: Days
• US Class Current: 607/119
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

A lead locking device has a lead insertion member having a proximal end and a distal end and has a lead engaging assembly. The lead insertion member defines a lumen extending along a longitudinal axis between the distal end and the proximal end of the lead engaging assembly. A mandrel disposed in the lumen of the lead engaging assembly extends along substantially the entire length of the lumen and protrudes beyond the most proximal end of the lead insertion member. The mandrel includes a distal portion in slidable contact with at least a portion of the lead engaging assembly. The lead engaging assembly has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging the lead from within the lumen of the lead. The lead engaging member has at least two expansion jaws that, in the first configuration, define a substantially cylindrical body. The expansion jaws translate radially outwardly from the longitudinal axis to engage the lumen of the lead when in the second configuration.

Claims

1. A lead locking device, comprising:

a lead insertion member having a proximal end and a distal end and comprising a lead engaging assembly, said lead insertion member defining a lumen extending along a longitudinal axis between said distal end and said proximal end of said lead engaging assembly,

a mandrel disposed in said lumen of said lead engaging assembly extending along substantially the entire length of said lumen and protruding beyond the most proximal end of said lead insertion member, said mandrel including a distal portion in slidable contact with at least a portion of said lead engaging assembly,

wherein said lead engaging assembly has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging said lead from within said lumen of said lead,

wherein said lead engaging member comprises at least two expansion jaws that in said first configuration define a substantially cylindrical body, and

wherein said at least two expansion jaws translate radially outward from the longitudinal axis to engage said lumen of said lead when in said second configuration.

2. The lead locking device of claim 1, wherein said distal portion of said mandrel has a conically shaped surface.

3. The lead locking device of claim 2, wherein said two expansion jaws include conically-shaped surfaces that correspond to the conically-shaped outer surface of said distal portion of said mandrel such that engagement of the surface of the distal portion of said mandrel with the surfaces of the at least two expansion jaws causes the expansion jaws to each translate radially outward with respect to the longitudinal axis of said lumen.

4. The lead locking device of claim 1, wherein the surfaces of the at least two expansion jaws include detents adapted to engage said lead when said distal end portion is in said second configuration.

5. The lead locking device of claim 1, wherein a forward end of each of said expanding jaws has generally a rounded configuration adapted to facilitate entry into said lumen of said lead.

6. The lead locking device of claim 5, wherein an end opposing said forward end of each said expansion jaw is resiliently connected to a connector section of said lead insertion member.

7. The lead locking device of claim 1, further comprising:

a second lead engaging assembly disposed between said distal end and said proximal end of said lumen,

wherein said second lead engaging assembly has a first configuration while being inserted into said lumen of said lead and a second configuration while engaging said lead from within said lumen of said lead.

8. The lead locking device of claim 7, wherein said second lead engaging assembly includes at least two expansion jaws that in said first configuration define a portion of a substantially cylindrical body, and each of said at least two expansion jaws translate radially outward from the longitudinal axis to engage said lumen of said lead when in said second configuration.

9. The lead locking device of claim 7, wherein said mandrel further includes a proximal cam portion for engagement with said second lead engaging assembly, an outer surface of said proximal cam portion being conically shaped.

10. The lead locking device of claim 9, wherein said at least two expansion jaws of said second engagement assembly include conically shaped inner surfaces that correspond to the conically shape outer surface of said proximal cam portion of said mandrel adapted to engage the outer surface of said proximal cam portion with the inner surfaces of the at least two expansion jaws of the second engagement assembly causes the expansion jaws to each translate radially outward with respect to the longitudinal axis of said lumen.

11. The lead locking device of claim 10, wherein the outer surfaces of the at least two expansion jaws of said second engagement member include detents for engagement with said lumen of said lead when said second engagement assembly is in said second configuration.

12. The lead locking device of claim 11, wherein said expansion jaws of said second engagement assembly are resiliently connected to an intermediate connector section of said lead insertion member.

13. The lead locking device of claim 12, wherein said intermediate connector section is resiliently connected to said ends of said expansion jaws of said second lead engagement assembly.

14. The lead locking device of claim 13, wherein said second engagement assembly and first mentioned engagement assembly are adapted to move from said first configuration to said second configuration substantially simultaneously.

15. The lead locking device of claim 14, wherein said first mentioned lead engaging assembly and said second lead engaging assembly have a maximum transverse diameter in said first configuration that is less than substantially all diameters of said lumen of said lead along substantially the entire length of said lead, and said first mentioned lead engaging assembly and said second lead engaging assembly have a transverse diameter in said second configuration that is at least substantially equal to diameters of said lumen of said lead.

16. The lead locking device of claim 15, wherein the two expansion jaws of the second lead engaging assembly are rotated approximately 90 degrees relative to the two expansion jaws of the first mentioned lead engaging assembly.

17. A lead locking device according to claim 1, further comprising a latching mechanism having at least a portion attached to said proximal end of said lead insertion member.

18. A lead locking device according to claim 17, wherein said latching mechanism has a portion attached to a proximal portion of said mandrel, said portion of said latching mechanism attached to said proximal end of said lead insertion member being selectively and removably attachable to said portion of said latching mechanism attached to said proximal portion of said mandrel.

19. A lead locking device according to claim 18, wherein said portion of said latching mechanism attached to said proximal end of said lead engaging member and said portion of said latching mechanism attached to said proximal portion of said mandrel cooperatively form a snap-fit latching mechanism.

20. A lead locking device according to claim 19, wherein said portion of said latching mechanism attached to said proximal end of said lead insertion member is a first hypotube having a detent defined by an inner surface, and said portion of said latching mechanism attached to said proximal portion of said mandrel has an outer surface defining at least two axially spaced apart indents, said detent being secured within one of said indents in a latched configuration of said latching mechanism.

21. A lead locking device according to claim 20, wherein the material of said first hypotube is stainless steel.

22. The lead locking device of claim 1, wherein the material of said mandrel is stainless steel.

23. The lead locking device of claim 1, wherein said lead engaging member engages said lead along at least about 30% of the entire longitudinal length of said lumen of said lead.

24. The lead locking device of claim 23, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes at least a portion of a proximal end and at least a portion of a distal end of said lumen of said lead.

25. The lead locking device according to claim 24, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes substantially the entire length of said lumen of said lead.

26. A lead locking device, comprising:

a lead engaging member having a distal end and a proximal end, said lead engaging member including a series of juxtaposed sections, each section forming a through hole and each through hole being aligned with an adjacent through hole of an adjacent section to define a bore hole extending along a longitudinal axis between said distal end and said proximal end;

a mandrel disposed in said bore hole and fixedly attached to at least one of said sections of said lead engaging member, said mandrel extending along substantially the entire length of said bore hole and protruding beyond the most proximal end of said lead engaging member,

wherein said lead engaging member has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging said lead from within said lumen of said lead.

27. The lead locking device of claim 26, wherein said lead engaging member engages said lead along at least about 30% of the entire longitudinal length of said lumen of said lead.

28. The lead locking device of claim 27, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes at least a portion of a proximal end and at least a portion of a distal end of said lumen of said lead.

29. The lead locking device according to claim 28, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes substantially the entire length of said lumen of said lead.

30. The lead locking device of claim 26, wherein each of said sections of said lead engaging member has a maximum transverse dimension that is less than substantially all of the diameters of said lumen of said lead along substantially the entire length of said lead so that said lead engaging member can be inserted into said lumen of said lead while in said first configuration.

31. The lead locking device of claim 30, wherein each of said sections of said lead engaging member is skewed with respect to a normal of the longitudinal axis so that when a torque is applied to said mandrel, each element is substantially inhibited from rotation by the adjacent element to cause some of said elements to radially deflect with respect to the longitudinal axis and engage said lumen of said lead in said second configuration.

32. The lead locking device of claim 30, wherein each of said sections of said lead engaging member is connected to an adjacent section with a member capable of transmitting torque.

33. The lead locking device of claim 32, wherein said member is a flexible member.

34. The lead locking device according to claim 26, wherein the juxtaposed sections are blocks.

35. A method of removing a lead implanted in a patient'"'"'s body, comprising:

inserting a lead locking device into a lumen defined by said lead, said lead locking device comprising a lead engaging member that extends along substantially the entire length of said lead, said lead engaging member having a narrower overall radial dimension in a relaxed configuration than in a radially torqued configuration, wherein said lead engaging member is in said relaxed configuration during said inserting said lead locking device;

applying a torque to said lead engaging member, wherein said applying said torque to said lead engaging member cause the lead engaging member to have an overall radial dimension that is substantially equal to an inner diameter of said lumen of said lead; and

applying traction to said lead locking device,

wherein said lead engaging member engages said lead along substantially the entire longitudinal length of said lead.

36. A method of removing a lead implanted in a patient'"'"'s body according to claim 35, further comprising:

releasing said torque applied to said lead engaging member prior to removing said lead from said patient'"'"'s body; and

removing said lead locking device from said lumen of said lead.

37. A method of removing a lead implanted in a patient'"'"'s body according to claim 36, further comprising:

reinserting said lead locking device back into said lumen defined by said lead;

applying a torque to said lead engaging member of said lead locking device after said reinserting said lead locking device; and

applying traction to said lead locking device.

38. A lead locking device, comprising:

a hypotube defining a plurality of openings therein, said hyptotube having a longitudinal axis extending between a distal end and a proximal end thereof;

a lead engaging member disposed in said hypotube, said lead engaging member including a plurality of bristles radially extending from a mandrel, said bristles being resiliently biased in an outward radial direction of the longitudinal axis, said mandrel being disposed generally along said longitudinal axis and extending along substantially the entire length of said hypotube and protruding beyond the most proximal end of said hypotube,

wherein said lead engaging member has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging said lead from within said lumen of said lead.

39. The lead locking device of claim 38, wherein said lead engaging member engages said lead along at least about 30% of the entire longitudinal length of said lumen of said lead.

40. A lead locking device according to claim 39, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes at least a portion of a proximal end and at least a portion of a distal end of said lumen of said lead.

41. A lead locking device according to claim 40, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes substantially the entire length of said lumen of said lead.

42. A lead locking device according to claim 38, wherein distal ends of said bristles of said lead engaging member are arranged within said hypotube in said first configuration, wherein the diameter of said hypotube is less than the diameters of said lumen of said lead.

43. A lead locking device according to claim 42, wherein the distal ends of said bristles of said lead engaging member extend through said openings of said hypotube in the second configuration, the distal ends in the second configuration having an overall transverse diametric dimension that is at least substantially equal to diameters of said lumen of said lead along substantially the entire length of said lead so that some of said distal ends engage said lumen.

44. The lead locking device according to claim 43, wherein all of said bristles are generally pointed in the same direction with the end attached to the mandrel being forward of the distal end of each bristle.

45. A lead locking device according to claim 38, further comprising a latching mechanism having at least a portion attached to said proximal end of said hypotube.

46. A lead locking device according to claim 45, wherein said latching mechanism has a portion attached to a proximal portion of said mandrel, said portion of said latching mechanism attached to said proximal end of said lead insertion member being selectively and removably attachable to said portion of said latching mechanism attached to said proximal portion of said mandrel.

47. A lead locking device according to claim 46, wherein said portion of said latching mechanism attached to said proximal end of said hypotube and said portion of said latching mechanism attached to said proximal portion of said mandrel cooperatively form a snap-fit latching mechanism.

48. A lead locking device according to claim 47, wherein said portion of said latching mechanism attached to said proximal end of said hypotube is a second hypotube having a detent defined by an inner surface, and said portion of said latching mechanism attached to said proximal portion of said mandrel has an outer surface defining at least two axially spaced apart indents, said detent being secured within one of said indents in a latched configuration of said latching mechanism.

49. A method of removing a lead implanted in a patient'"'"'s body, comprising:

inserting a lead locking device into a lumen defined by said lead, said lead locking device comprising a hypotube having a plurality of openings formed therein, a lead engaging member disposed in said hypotube, said lead engaging member including a plurality of bristles radially extending from a mandrel, said bristles being resiliently biased in the outward radial direction of the longitudinal axis, said bristles being disposed within said hypotube in a first configuration for inserting said lead locking device into said lead,

applying an axial force to said mandrel so that bristles of said lead engaging member protrude from said openings to engage the lead, wherein the overall radial dimension of the distal ends of said bristles is substantially equal to an inner diameter of said lumen of said lead; and

applying traction to said lead locking device,

wherein said lead engaging member engages said lead along substantially the entire longitudinal length of said lead.

50. A method of removing a lead implanted in a patient'"'"'s body according to claim 49, further comprising:

applying an axial force in the opposite direction to that for applying traction so that the distal ends of said bristles retract through said openings and are disposed within said hyptotube prior to removing said lead from said patient'"'"'s body; and

removing said lead locking device from said lumen of said lead.

51. A method of removing a lead implanted in a patient'"'"'s body according to claim 49, further comprising:

reinserting said lead locking device back into said lumen defined by said lead;

applying an axial force to said mandrel so that bristles of said lead engaging member protrude from said openings to engage the lumen of the lead; and

applying traction to said lead locking device after said reinserting said lead locking device

52. A lead locking device, comprising:

a mandrel; and

a lead engaging member having a distal end and a proximal end, said lead engaging member including a plurality of radially expandable elastic members disposed around said mandrel,

wherein said mandrel extends along a longitudinal axis between said distal end and said proximal end, said mandrel protruding beyond the most proximal end of said lead engaging member, and

wherein said lead engaging member has a first configuration while being inserted into a lumen of a lead and a second configuration while engaging said lead from within said lumen of said lead.

53. The lead locking device of claim 52, wherein said lead engaging member engages said lead along at least about 30% of the entire longitudinal length of said lumen of said lead.

54. A lead locking device according to claim 53, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes at least a portion of a proximal end and at least a portion of a distal end of said lumen of said lead.

55. A lead locking device according to claim 53, wherein said at least 30% of the entire longitudinal length of said lumen of said lead includes substantially the entire length of said lumen of said lead.

56. A lead locking device according to claim 52, wherein said lead engaging member has a maximum transverse diameter in said first configuration that is less than substantially all diameters of said lumen of said lead along substantially the entire length of said lead, and said lead engaging member has a transverse diameter in said second configuration that is at least substantially equal to diameters of said lumen of said lead along substantially the entire length of said lead.

57. A lead locking device according to claim 52, wherein said plurality of expandable elastic members includes a plurality of expandable elastic ring sections that are substantially relaxed in the first configuration and radially expanded under a compressive force in the second configuration.

58. A lead locking device according to claim 57, further comprising spacers disposed between said plurality of expandable elastic ring sections, each of said spacers forming a ring and being disposed around said mandrel.

59. A lead locking device according to claim 58, wherein a distal spacer is fixedly attached to a distal end of said mandrel proximate said distal end of said lead engaging member.

60. A lead locking device according to claim 58, further comprising a tubular elastic jacket disposed over said lead engaging member.

61. A lead locking device according to claim 52, wherein said plurality of expandable elastic members includes a series of beveled washers that are substantially relaxed in the first configuration and radially expanded under a compressive force in the second configuration.

62. A lead locking device according to claim 52, wherein said plurality of expandable elastic members includes a single expansion element, said single expansion element includes a series of radially expandable elastic sections, each section being integrally connected to an adjacent section, each of said elastic sections being substantially relaxed in the first configuration and radially expanded under a compressive force in the second configuration.

63. A lead locking device according to claim 56, wherein each of said elastic members have substantially no compressive load applied thereto in the first configuration, and the elastic members have a compressive force applied thereto in the second configuration so that an outer diameter of each elastic member expands so that some of the elastic members engage the lumen of the lead.

64. A lead locking device according to claim 63, further comprising a latching mechanism having at least a portion attached to said proximal end of said lead engaging member.

65. A lead locking device according to claim 64, wherein said latching mechanism has a portion attached to a proximal portion of said mandrel, said portion of said latching mechanism attached to said proximal end of said lead engaging member being selectively and removably attachable to said portion of said latching mechanism attached to said proximal portion of said mandrel.

66. A lead locking device according to claim 65, wherein said portion of said latching mechanism attached to said proximal end of said lead engaging member and said portion of said latching mechanism attached to said proximal portion of said mandrel cooperatively form a snap-fit latching mechanism.

67. A lead locking device according to claim 66, wherein said portion of said latching mechanism attached to said proximal end of said lead engaging member is a first hypotube having a detent defined by an inner surface, and said portion of said latching mechanism attached to said proximal portion of said mandrel has an outer surface defining an indent, said detent being secured within said indent in a latched configuration of said latching mechanism.

68. A method of removing a lead implanted in a patient'"'"'s body, comprising:

inserting a lead locking device into a lumen defined by said lead, said lead locking device comprising a plurality of radially expandable elastic members disposed around a mandrel, each of said plurality of radially expandable elastic members having a smaller radial dimension in a relaxed configuration than in a compressed configuration, wherein said elastic members being in a relaxed configuration during said inserting said lead locking device;

applying an axial compressive force to said elastic members so that said elastic members of said lead engaging member extend radially outward to engage the lumen of the lead in the compressed configuration, wherein the transverse diameter of some of the elastic members in the compressed configuration are substantially equal to an inner diameter of said lumen of said lead;

applying traction to said lead locking device,

wherein said lead engaging member engages said lead along substantially the entire longitudinal length of said lead.

69. A method of removing a lead implanted in a patient'"'"'s body according to claim 68, further comprising:

releasing the compressive force applied to the elastic members prior to removing said lead from said patient'"'"'s body; and

removing said lead locking device from said lumen of said lead.

70. A method of removing a lead implanted in a patient'"'"'s body according to claim 69, further comprising:

reinserting said lead locking device back into said lumen defined by said lead;

applying an axial compressive force to said elastic members so that said elastic members of said lead engaging member extend radially outward to engage the lumen of the lead in the compressed configuration;

applying traction to said lead locking device.

71. A method of removing a lead implanted in a patient'"'"'s body, comprising:

attaching a lead locking device to said lead along at least about 30% of an entire longitudinal length of said lead; and

applying a traction force to said lead locking device.

72. A method of removing a lead implanted in a patient'"'"'s body according to claim 71, further comprising inserting a lead engaging portion of said lead locking device into a lumen defined by said lead.

73. A method of removing a lead implanted in a patient'"'"'s body according to claim 72, wherein said attaching said lead locking device to said lead comprises attaching said lead engaging member along at least about 30% of said lumen defined by said lead.

74. A method of removing a lead implanted in a patient'"'"'s body according to claim 73, wherein said at least about 30% of said lumen defined by said lead includes at least a proximal portion and a distal portion of said lumen defined by said lead.

75. A method of removing a lead implanted in a patient'"'"'s body according to claim 73, wherein said at least about 30% of said lumen defined by said lead includes substantially said entire longitudinal length of said lead.

76. A method of removing a lead implanted in a patient'"'"'s body according to claim 72, further comprising sliding a catheter over said lead wherein said lead extends along a lumen defined by said catheter.

77. A method of removing a lead implanted in a patient'"'"'s body according to claim 76, wherein said catheter is a laser catheter.

78. A method of removing a lead implanted in a patient'"'"'s body according to claim 73, further comprising detaching said lead engaging member from said lead.

79. A method of removing a lead implanted in a patient'"'"'s body according to claim 78, further comprising re-attaching said lead locking device to said lead.