Thermal detachment system for implantable devices

• US 20060200192A1
• Filed: 05/03/2006
• Published: 09/07/2006
• Est. Priority Date: 08/25/2004
• Status: Active Grant

• Current Assignee: Joseph Gulachenski, Matthew Fitz
• Original Assignee: Joseph Gulachenski, Matthew Fitz
• Inventors: Gulachenski, Joseph, Fitz, Matthew
• Granted Patent: US 9,414,819 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Abstract

The present invention provides for implant device delivery apparatuses and related methods of use. The delivery systems of the present invention incorporate a stretch resistant tube that advantageously makes the implant device, such as an embolic coil, stretch resistant while a delivery system is being used to position the implant device at a desired target site.

Claims

1-33. -33. (canceled)

34. A method of manufacturing an implant delivery system comprising a delivery pusher component, a tether defining a first end and a second end, and an implant component;

said method comprising the steps of;

a. attaching the first end of said tether to a first component of said implant delivery system;

b. placing a portion of the first component in proximity to a portion of a second component;

c. placing tension on said tether;

d. attaching said second end of said tether to the second component.

35. The method of claim 34, wherein said first component is said implant component and said second component is said delivery pusher component.

36. The method of claim 34, wherein said first component is said delivery pusher component and said second component is said implant component.

37. The method of claim 34, wherein said implant component is a coil defining an inner lumen, a distal end, and a proximal end.

38. The method of claim 37, wherein said tether is attached near said proximal end of said coil.

39. The method of claim 37, wherein said tether passes substantially through said inner lumen of said coil and is attached near said distal end of said coil.

40. The method of claim 34, wherein said implant component is a stent.

41. The method of claim 34, wherein said tether is disposed in proximity to a heater.

42. The method of claim 41, wherein said implant is released from said delivery pusher by activation of said heater.

43. The method of claim 34, wherein said tether is comprised of a material selected from a group consisting of:

polypropylene, polyamide, ethylene vinyl alcohol, polyethylene, and polyolefin elastomer.

44. The method of claim 34, wherein said tension is in a direction approximately coaxial to said delivery pusher.

45. The method of claim 34, wherein said tension is less than about 250 grams.

46. An implant delivery system comprising:

a delivery pusher having a proximal end and a distal end;

an implant disposed at a distal end of said delivery pusher;

a thermally activated attachment member connecting said implant to said delivery pusher;

a heating element connected to said attachment member; and

said thermally activated attachment member sized to release said implant device from said delivery pusher less than 1 second after activation of said heating element.

47. The implant delivery system of claim 46, wherein said thermally activated attachment member is in a stressed state when connecting said implant to said delivery pusher.

48. The implant delivery system of claim 47, wherein said stressed state of said thermally activated attachment member is a stretched state.

49. The implant delivery system of claim 46, wherein said thermally activated attachment member is comprised of a material selected from a group consisting of:

polypropylene, polyamide, polyethylene, and PET.

50. The implant delivery system of claim 46, wherein said heating element comprises a heating coil contacting said thermally activated attachment member.

51. The implant delivery system of claim 46, wherein said thermally activated attachment member is comprised of an elongated filament having a diameter sized to melt within one second of said activation of said heating element.

52. The implant delivery system of claim 46, wherein said thermally activated attachment member is comprised of a material that melts in less than one second upon receiving heat from said heating element.

53. A method of releasing an implant from a delivery device comprising:

providing a delivery device having an implant connected to said delivery device with an engagement member;

positioning a distal end of said delivery device at a target location within a lumen of a patient;

activating a heating member of said delivery device such that said engagement member releases said implant from said delivery device in less than about one second after activation of said heating member.

54. The method of claim 53, wherein said engagement member releases said implant from said delivery device about 0.75 seconds after the activating of said heating member.

55. The method of claim 53, wherein the providing of a delivery device includes providing said engagement member in a pre-stressed state as between said implant and said delivery device.

56. The method of claim 53, wherein the activating of a heating member includes applying current to said heating member selected from a group consisting of alternating current, direct current, and radiofrequency current.

57. An implant delivery system comprising:

a delivery pusher;

said delivery pusher including a first radiopaque layer disposed along a portion of the length of said delivery pusher; and

said delivery pusher including a second radiopaque layer overlying said first radiopaque layer;

wherein said second radiopaque layer includes a first region having a first thickness and a second region having a second thickness, said first thickness being different from said second thickness.

58. The implant delivery device of claim 57, wherein said second radiopaque layer includes a third region having a third thickness, said third thickness being different from said first and second thickness.

59. The implant delivery device of claim 57, wherein said first radiopaque layer has a first radiopaque value and said second radiopaque layer has a second radiopaque value different than said firs radiopaque value.

60. The implant delivery device of claim 59, wherein said first radiopaque value is higher than said second radiopaque value.

61. The implant delivery device of claim 59, wherein said first radiopaque layer comprises a material selected from the group consisting of tungsten, tantalum, platinum, and gold.

62. The implant delivery device of claim 59, wherein said second radiopaque layer comprises a material selected from the group consisting of Elgiloy, Nitinol, and stainless steel.

63. The implant delivery device of claim 57, where said second region has a length of about 3 cm and is positioned toward a distal end of said delivery pusher.

64. A method of delivering an implant comprising:

providing an implant delivery device comprising a first radiopaque layer and a second radiopaque layer, said second radiopaque layer having a transition area between of a first region having a first diameter and a second layer having a second diameter;

providing a delivery catheter having a radiopaque marker;

positioning a distal end of said delivery catheter at a target location within a patient;

introducing said implant delivery device into a lumen of said delivery catheter;

aligning said transition area of said implant delivery device with said radiopaque marker on said delivery catheter; and

delivering an implant.

65. An implant device delivery system comprising:

a delivery pusher having a proximal end and a distal end and a heater member;

a conductive core member disposed on said delivery pusher towards said proximal end of said delivery pusher;

an insulating layer disposed on at least a portion of said conductive core member;

a conductive layer disposed on at least a portion of said insulating layer;

a first wire connecting said conductive core to said heater member; and

a second wire connecting said conductive layer to said heater member.

66. The implant device delivery system of claim 65, wherein said conductive layer is comprised of a material selected from a group consisting of silver, gold, platinum, steel, copper, conductive polymer, or conductive materials.

67. The implant device delivery system of claim 65, wherein a portion of said conductive core is exposed.

68. A method of detecting detachment of an implant from a delivery pusher comprising:

providing an implant connected to a delivery pusher at a distal end of said delivery pusher;

determining a first inductance value of said delivery pusher;

executing an operation intended to detach said implant from said delivery pusher;

determining a second inductance value of said delivery pusher;

deciding whether detachment of said implant from said delivery pusher has occurred based on an evaluation of said first and second inductance values.

69. The method of claim 68, wherein said determining of said first inductance value includes measuring a first inductive resistance.

70. The method of claim 69, wherein said determining a said second inductance value includes measuring a second inductive resistance.

71. The method of claim 70, wherein said first inductive resistance value and said second inductive resistance value is measured with respect to a heater coil disposed in said delivery pusher.

72. A method of detecting detachment of an implant from a delivery pusher comprising:

providing a delivery pusher housing a heater member and a detachable implant;

performing a first electrical property measurement of said heater member;

causing said heater member to increase in temperature so as to disconnect said implant from said delivery pusher;

performing a second electrical property measurement of said heater member;

determining disconnection of said implant from said delivery pusher based on an evaluation of said first and second electrical property measurement of said heater member.

73. The method of claim 72, wherein said performing a first electrical property measurement includes measuring a first inductive resistance of said heater member.

74. The method of claim 73, wherein said performing a second electrical property measurement includes measuring a second inductive resistance of said heater member.

75. The method of claim 72, wherein said performing a first electrical property measurement includes measuring a first time constant of said heater member.

76. The method of claim 75, wherein said performing a second electrical property measurement includes measuring a second time constant of said heater member.

77. An implant device delivery system comprising:

a delivery pusher having a proximal end and a distal end;

a stretch resistant tube coupled to the distal end of the delivery pusher;

a heating element coupled to the proximal end of the stretch resistant tube; and

an implant device coupled to the stretch resistant tube distal from the heating element.

78. The implant device delivery system of claim 77, wherein the heating element is disposed on an exterior surface of the stretch resistant tube.

79. The implant device delivery system of claim 77, further comprising:

a positive electrical wire coupled to the heating element; and

a negative electrical wire coupled to the heating element;

wherein the positive electrical wire and the negative electrical wire are configured to apply a current to the heating element.

80. The implant device delivery system of claim 79, further comprising a power source coupled to the positive electrical wire and the negative electrical wire.

81. The implant device delivery system of claim 77, further comprising an atraumatic distal end.

82. The implant device delivery system of claim 77, wherein the implant device comprises a coil.

83. The implant device delivery system of claim 77, wherein the delivery pusher comprises a hollow tube.

84. The implant device delivery system of claim 77, wherein the delivery pusher comprises a solid core wire.

85. The implant device delivery system of claim 77, wherein the delivery pusher comprises a hollow tube and a flexible coil.

86. The implant device delivery system of claim 77, wherein the delivery pusher comprises a material chosen from the group consisting of plastic, steel, platinum, and steel coils.

87. The implant device delivery system of claim 77, wherein the stretch resistant tube comprises a hollow tube.

88. The implant device delivery system of claim 77, wherein the stretch resistant tube comprises a solid member.

89. The implant device delivery system of claim 77, wherein the stretch resistant tube is formed from a polymer.

90. The implant device delivery system of claim 77, wherein the heating element is formed from a material chosen from the group consisting of tantalum, tungsten, steel, platinum, and mangalin.

91. The implant device delivery system of claim 77, wherein the heating element comprises a structure chosen from the group consisting of a coil, a band, a pipe, and a hypotube.

92. The implant device delivery system of claim 77, further comprising an insulting sleeve surrounding the heating element.

93. The implant device delivery system of claim 77, further comprising a compressive spring configured to detach the implant device from the implant device delivery system.

94. An implant device delivery system comprising:

a delivery pusher comprising a proximal end, a distal end, a lumen therebetween, and a core wire disposed in the lumen;

a stretch resistant tube coupled to the distal end of the delivery pusher;

a heating element disposed within the lumen of the delivery pusher and formed by a positive electrical wire, a negative electrical wire, and the core wire; and

an implant device coupled to the stretch resistant tube distal from the heating element.

95. The implant device delivery system of claim 94, further comprising a power source coupled to the positive electrical wire and the negative electrical wire, the positive electrical wire and the negative electrical wire being coupled to the core wire.

96. The implant device delivery system of claim 94, wherein the implant device comprises a coil.

97. The implant device delivery system of claim 94, further comprising a compressive spring coupled to the stretch resistant tube proximal to the implant device, wherein the compressive spring is configured to detach the implant device from the implant device delivery system.

98. The implant device delivery system of claim 94, further comprising an atraumatic distal end.