Tissue fixation devices and methods

Patent metadata

Field	Value
Publication number	US-2016287387-A1
Application number	US-201514677294-A
Country	US
Kind code	A1
Filing date	Apr 2, 2015
Priority date	Apr 2, 2015
Publication date	Oct 6, 2016
Grant date	—

Abstract

The present disclosure describes tissue gripping devices, systems, and methods for gripping mitral valve tissue during treatment of a mitral valve and while a tissue fixation device is implanted in the mitral valve. The tissue gripping device includes a flexible member and one or more tissue gripping members coupled to one or more arms of the flexible member. The flexible member is formed from a shape-memory material, such as nitinol, and the tissue gripping member(s) are formed from a material that is more rigid than the shape-memory material. The tissue gripping member(s) are attached to the flexible member by threading or looping suture lines around and/or through the tissue gripping member(s) and the flexible member and/or by applying a cover material to the tissue gripping device to hold the tissue gripping member(s) against the flexible member.

First claim

What is claimed is:

1 . A tissue gripping device comprising:
a flexible member formed from a shape-memory material, the flexible member comprising a base section and an arm, the arm having a first end connected to the base section, a free end extending away from the base section, and an attachment surface disposed between the joining end and the free end; and at least one tissue gripping member formed from a second material, the second material being more rigid than the shape-memory material, the tissue gripping member comprising a mating surface coupled to the attachment surface of the arm to join the tissue gripping member to the flexible member, and a tissue gripping surface disposed opposite the mating surface, the tissue gripping surface including a frictional element configured to resist movement of tissue away from the tissue gripping surface after the tissue has contacted the tissue gripping surface.

2 . The tissue gripping device of claim 1 , wherein the shape-memory material is nitinol.

3 . The gripping fixation device of claim 1 , wherein the second material is selected from the group consisting of: cobalt-chromium alloy, cobalt-chromium-nickel alloy, cobalt-chromium-nickel-iron-molybdenum-manganese alloy, and stainless steel.

4 . The tissue gripping device of claim 1 , wherein the frictional element is formed as a plurality of raised barbs disposed along a side edge of the tissue gripping member, and wherein the tissue gripping member includes a plurality of slotted recesses disposed along the side edge at sections adjacent to the raised barbs.

5 . The tissue gripping device of claim 4 , further comprising at least one suture line encircling at least a portion of the tissue gripping member and at least a portion of the arm, the suture line being configured to fasten the tissue gripping member to the arm, the suture line passing through and lodging within one or more of the slotted recesses as it encircles the tissue gripping member and the arm.

6 . The tissue gripping device of claim 1 , wherein the arm further comprises at least one hole, and wherein the tissue gripping member further comprises at least one hole configured to correspond with the hole of the arm as the mating surface of the tissue gripping member is coupled to the attachment surface of the arm.

7 . The tissue gripping device of claim 6 , further comprising a suture line configured to fasten the tissue gripping member to the arm, the suture line passing through the hole of the arm and the hole of the tissue gripping member.

8 . The tissue fixation device of claim 1 , further comprising a cover, the cover surrounding the arm and the tissue gripping member to hold the tissue gripping member to the flexible member.

9 . The tissue fixation device of claim 1 , wherein
the frictional element is formed as a plurality of raised barbs disposed along a side edge of the tissue gripping member, and wherein the tissue gripping member includes a plurality of slotted recesses disposed along the side edge at sections adjacent to the raised barbs, and wherein the arm further comprises at least one hole and the tissue gripping member further comprises at least one hole configured to correspond with the hole of the arm as the mating surface is coupled to the attachment surface, and wherein the tissue fixation device further comprises at least one suture line encircling at least a portion of the tissue gripping member and at least a portion of the arm, the suture line passing through the hole of the first or second arm and the hole of the tissue gripping member and passing through and lodging within one or more of the slotted recesses, and wherein the tissue fixation device further comprises a polymer cover surrounding the arm and the tissue gripping member to hold the tissue gripping member to the flexible member.

10 . The tissue fixation device of claim 1 , wherein the tissue gripping member is joined to the flexible member by welding or soldering the mating surface of the tissue gripping member to the attachment surface of the arm.

11 . The tissue fixation device of claim 1 , wherein the mating surface of the tissue gripping member includes a press-fit portion, and the attachment surface of the arm includes a corresponding press-fit portion allowing the tissue gripping member to be joined to the flexible member by engaging the corresponding press-fit portions.

12 . The tissue fixation device of claim 1 , wherein the arm further comprises a proximal side and a distal side, and wherein the attachment surface is disposed on the distal side.

13 . The tissue fixation device of claim 12 , wherein the arm is configured to bend proximally while moving from a relaxed configuration toward a stressed configuration, and to resiliently flex distally toward a relaxed configuration when positioned in a stressed configuration, thereby forcing the attachment surface of the arm against the tissue gripping member as the arm flexes distally toward a relaxed configuration.

14 . A tissue fixation system configured for intravascular delivery and for use in joining mitral valve tissue during treatment of the mitral valve, the system comprising:
a body; a proximal element comprising:
a flexible member formed from a shape-memory material, the flexible member comprising a base section and an arm, the arm having a first end connected to the base section, a free end extending away from the base section, and an attachment surface disposed between the joining end and the free end; and
at least one tissue gripping member formed from a second material, the second material being more rigid than the shape-memory material, the tissue gripping member comprising a mating surface coupled to the attachment surface of the arm to join the tissue gripping member to the flexible member, and a tissue gripping surface disposed opposite the mating surface, the tissue gripping surface including a frictional element configured to resist movement of tissue away from the tissue gripping surface after the tissue has contacted the tissue gripping surface; and
a distal element having a first end pivotally coupled to the body and extending to a free second end and a tissue engagement surface between the first and second end, the tissue engagement surface being configured to approximate and engage a portion of the leaflets of the mitral valve, wherein the proximal element is configured to cooperate with the distal element to form a space for receiving a portion of mitral valve tissue therebetween.

15 . The system of claim 14 , wherein the frictional element is formed as a plurality of raised barbs disposed along a side edge of the tissue gripping member, and
wherein the tissue gripping member includes a plurality of slotted recesses disposed along the side edge at sections adjacent to the raised barbs, and wherein the arm further comprises at least one hole and the tissue gripping member further comprises at least one hole configured to correspond with the hole of the arm as the mating surface of the tissue gripping member is coupled to the attachment surface of the arm, and the proximal element further comprising at least one suture line encircling the tissue gripping member and the arm, the suture line passing through the hole of the arm and the hole of the tissue gripping member and passing through and lodging within one or more of the slotted recesses.

16 . The system of claim 14 , wherein the shape-memory material is nitinol and the second material is a cobalt-chromium-nickel-iron-molybdenum-manganese alloy.

17 . A method of man

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Wei Michael F

Classifications

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61B17/122

  Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} · CPC title

• A61B2017/00867

  shape memory effect · CPC title

• A61B2017/00964

  composite · CPC title

• A61B2017/00243

  cardiac · CPC title