CLOT CAPTURE SYSTEMS AND ASSOCIATED METHODS

• US 20110125181A1
• Filed: 07/22/2009
• Published: 05/26/2011
• Est. Priority Date: 07/22/2008
• Status: Active Grant

• Current Assignee: Neuravi Limited (Johnson & Johnson)
• Original Assignee: Neuravi Limited (Johnson & Johnson)
• Inventors: Brady, Eamon, O'Shaughnessy, John, Vale, David, Razavi, Mahmood
• Granted Patent: US 8,777,976 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped

Abstract

A clot capture system for disengaging a clot 2001 from a vessel wall 2002 and removing the clot 2001 from the vessel 202, comprises a clot capture device 2140 for placement on a distal side of a clot 2001. The clot capture device 2140 has a retracted delivery configuration and an expanded deployed configuration. The clot removal device has a proximal support frame 2012, and a distal fibre net 2130. The support frame 2012 has a retracted delivery configuration and an expanded deployed configuration. The proximal support frame 2012 in the expanded configuration defines a proximal inlet mouth for engaging a clot 2001 and a net 2130 for confining the clot 2001. An elongate member facilitates capture and/or withdrawal of a clot 2001 from a vessel 2002. The system also comprises a clot debonding device 2091 for placement on a proximal side of a clot 2001. The clot debonding device 2091 has a retracted delivery configuration and an expanded deployed configuration and comprises a clot engagement element 2112 which defines a distal abutment in the deployed configuration for urging a clot 2001 into the clot cap 2140.

Claims

1-45. -45. (canceled)

46. A clot removal device for restoring blood flow to a vessel occluded by an obstructive clot, the device having an expanded deployed configuration, and a retracted delivery configuration in which it may be advanced through a microcatheter across said obstructive clot, and the device configured such that upon deployment at least a part of the device is deployed distal to the clot and at least a portion is deployed proximal to the clot, the device comprising:

a frame, a net and a shaft,

the frame comprising at least two struts and at least one crown, and,

the frame also comprising at least one connector element, the proximal end of the at least one connector element being connected to the shaft,

the frame comprising a cylindrical section in the expanded configuration, said cylindrical section being configured to engage with a clot, and the net being configured to confine at least a portion of a clot.

47. The clot removal device as claimed in claim 46 wherein the shaft comprises an inner member and an outer member which are movable relative to one another to assist the expansion of the frame.

48. The clot removal device as claimed in claim 46 wherein the shaft comprises an elongate member which is movable relative to the frame.

49. The clot removal device as claimed in claim 46 wherein the frame in the expanded configuration defines at least one inlet mouth for engaging a clot.

50. The clot removal device as claimed in claim 46 wherein the shaft is extendable proximally exterior of a patient and wherein movement of the shaft causes movement of a captured clot.

51. The clot removal device as claimed in claim 46 wherein the frame comprises a plurality of net attachment features.

52. The clot removal device as claimed in claim 51 wherein the net attachment features comprise holes through which at least one fibre is looped.

53. The clot removal device as claimed in claim 46 wherein the net attachment features of adjacent struts are offset from one another in a wrapped configuration.

54. The clot removal device as claimed in claim 46 wherein the net comprises at least one fibre of less than 25 microns in diameter.

55. The clot removal device as claimed in claim 46 wherein the net comprises at least one fibre having an ultimate tensile strength of at least 2 GPa.

56. The clot removal device as claimed in claim 46 wherein the net comprises at least one fibre and wherein the fibre is of a material selected from one or more of nitinol, stainless steel, ultra high molecular weight polyethylene, and an aramid such as Kevlar.

57. A clot removal device for restoring blood flow to a vessel occluded by an obstructive clot, the device having an expanded deployed configuration, and a retracted delivery configuration in which it may be advanced through a microcatheter across said obstructive clot, the device being configured such that upon deployment, at least a part of the device is deployed distal to the clot and at least a portion is deployed proximal to the clot, the device comprising:

a shaft, aproximal section and a distal section,

a distal end of said shaft being attached to a proximal end of said proximal section,

said proximal section comprising an axially extending portion, a radially extending portion and a circumferentially extending portion,

said proximal section also comprising at least two struts and at least one crown,

and said distal section comprising a net,

the net being configured to confine at least a portion of a clot.

58. The clot removal device as claimed in claim 57 wherein the shaft comprises an elongate member which is movable relative to the proximal section.

59. The clot removal device as claimed in claim 57 wherein the proximal section in the expanded configuration defines at least one inlet mouth for engaging a clot.

60. The clot removal device as claimed in claim 57 wherein the shaft is extendable proximally exterior of a patient and wherein movement of the shaft causes movement of a captured clot.

61. The clot removal device as claimed in claim 57 wherein the net comprises at least one fibre of less than 25 microns in diameter.

62. The clot removal device as claimed in claim 57 wherein the net comprises at least one fibre having an ultimate tensile strength of at least 2 GPa.

63. The clot removal device as claimed in claim 57 wherein the net comprises at least one fibre and wherein the fibre is of a material selected from one or more of nitinol, stainless steel, ultra high molecular weight polyethylene, and an aramid such as Kevlar.

64. A method for removing an obstruction from a vessel comprising providing a clot retrieval device, the device comprising an elongate member having a capture frame and capture net affixed thereto, the capture frame having a collapsed configuration and an expanded configuration and the elongate member comprising an inner member and an outer member, the method further comprising the steps of:

advancing the device with the capture frame in the collapsed configuration across the obstruction;

moving the inner member relative to the outer member to support the expansion of the frame;

advancing the device proximally to capture the obstruction; and

removing the clot retrieval device from the patient.

65. A method for removing an obstruction from a vessel comprising providing a clot retrieval device, the device comprising an elongate member having a capture frame affixed there to, the capture frame having a collapsed configuration and an expanded configuration, the elongate member comprising a shaft and a guidewire,

the method further comprising the steps of:

advancing the device with the capture frame in the collapsed configuration across the obstruction;

deploying the device across the obstruction;

retracting the device shaft to move the capture frame proximally to capture and withdraw some or all of the obstruction whilst leaving the guidewire in position to retain access to the vessel; and

removing the clot retrieval device from the patient.

66. The method as claimed in claim 65 wherein the device is advanced over the guidewire and through a microcatheter to cross the obstruction.

67. The clot removal device as claimed in claim 65 wherein the capture frame comprises strut elements and a capture net.

68. The clot removal device as claimed in claim 67 wherein the strut elements comprise a plurality of net attachment features.