Body lumen device anchor, device and assembly

• US 7,309,354 B2
• Filed: 11/19/2004
• Issued: 12/18/2007
• Est. Priority Date: 05/08/2002
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kowalsky, Leonard, Mathis, Mark L., Beeson, Cruz, Reuter, David G.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/994,169
• Publication Number:
  US 20050149180A1
• Time in Patent Office: 1,124 Days
• Field of Search: 623 136- 237, 623/1.11
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0086 with bar code
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

An anchor anchors a therapeutic device having an elongated body within a body lumen. The anchor includes a fixation member carried on the device which is adjustable from a first configuration that permits placement of the device in the body lumen to a second configuration that anchors the device within the body lumen. The anchor further includes a lock that locks the fixation member in the second configuration. The fixation member may be locked in any one of a plurality of intermediate points between the first configuration and a maximum second configuration.

Claims

1. A mitral valve regurgitation treatment device comprising:

an elongated body dimensioned to be placed in a coronary sinus of a heart adjacent a mitral valve annulus; and

an anchor adjustable from a first configuration that permits placement of the device in the coronary sinus to a second configuration that anchors the device within the coronary sinus, the anchor comprising;

an elongated fixation member having a first end coupled to the device body and a second end opposite the first end, wherein the fixation member extends along the device body closely spaced to the device body when the anchor is in the first configuration and wherein the fixation member is pivoted from the device body when the anchor is in the second configuration to engage the coronary sinus and anchor the device in the coronary sinus; and

a support member having a first end hingedly coupled to the fixation member second end, the support member rendering the fixation member substantially rigid when the anchor is in the second configuration.

2. The device of claim 1 further comprising a lock that locks the fixation member in the anchor'"'"'s second configuration.

3. The device of claim 2 wherein the lock is releasable to release the fixation member from the second configuration to permit the device to be moved within the coronary sinus.

4. The device of claim 2 wherein the lock locks the support member second end on the device body.

5. The device of claim 4 wherein the support member second end is slidable on the device body.

6. The device of claim 1 wherein the fixation member is deformable to permit the device to be moved within the coronary sinus.

7. The device of claim 1 wherein the fixation member is a first fixation member, the anchor further comprising a second fixation member having a first end coupled to the device body and a second end opposite the first end, wherein the second fixation member extends along the device body closely spaced to the device body when the anchor is in the first configuration and wherein the second fixation member is pivoted from the device body when the anchor is in the second configuration to engage the coronary sinus and anchor the device in the coronary sinus, the support member being hingedly coupled to the second fixation member second end, the support member rendering the second fixation member substantially rigid when the anchor is in the second configuration.

8. The device of claim 1 wherein the fixation member is a first fixation member and the support member is a first support member, the anchor further comprising:

a second fixation member having a first end coupled to the device body and a second end opposite the first end, wherein the second fixation member extends along the device body closely spaced to the device body when the anchor is in the first configuration and wherein the second fixation member is pivoted from the device body when the anchor is in the second configuration to engage the coronary sinus and anchor the device in the coronary sinus, and

a second support member having a first end hingedly coupled to the second fixation member second end, the second support member rendering the second fixation member substantially rigid when the anchor is in the second configuration.

9. A device that effects the condition of a mitral valve annulus of a heart comprising:

an elongated body dimensioned to be placed in the coronary sinus of the heart adjacent the mitral valve annulus;

a fixation member carried by the device, the fixation member being adjustable from a first configuration that permits placement of the device in the coronary sinus to a second configuration that anchors the device within the coronary sinus, the fixation member being elongated and having a first end hingedly coupled to the device body, wherein the fixation member extends along the device body closely spaced to the device body when in the first configuration and wherein the fixation member is pivoted from the device body when in the second configuration to engage the coronary sinus and anchor the device in the coronary sinus, and wherein the fixation member includes a second end opposite the first end;

a support that renders the fixation member substantially rigid when in the second configuration, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end; and

a lock that locks the fixation member in the second configuration, wherein the lock locks the support member second end on the device body.

10. The device of claim 9 wherein the support member second end is slidable along the device body.

11. The device of claim 9 wherein the device comprises a plurality of the fixation members and support members.

12. An assembly that effects the condition of a mitral valve annulus of a heart, the assembly comprising:

a mitral valve therapy device dimensioned to be placed in the coronary sinus adjacent the mitral valve annulus, the device including an elongated body, a fixation member carried by the device, the fixation member being adjustable from a first configuration that permits placement of the device in the coronary sinus to a second configuration that anchors the device within the coronary sinus, and a lock that locks the fixation member in the second configuration, the fixation member being elongated and having a first end hingedly coupled to the device body, wherein the fixation member extends along the device body when in the first configuration, and wherein the fixation member includes a second end opposite the first end;

a flexible catheter having a lumen that receives the device and being dimensioned to be advanced into the coronary sinus to place the device adjacent the coronary sinus, wherein the catheter transitions the fixation member from the first configuration to the second configuration and wherein the fixation member is pivoted from the device body into the second configuration by distal movement of the catheter with respect to the device to engage the coronary sinus and anchor the device in the coronary sinus;

a support that renders the fixation member substantially rigid when in the second configuration, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end, and wherein the lock locks the support member second end on the device body when the support member second end is in a locked position; and

a tether receivable by the catheter lumen and engagable with the device to pull the device distally with respect to the catheter.

13. The assembly of claim 12 further comprising an elongated pusher that is received by the lumen of the catheter proximal to the device and that permits the device and the catheter to be moved opposite each other.

14. The assembly of claim 12 wherein the support member second end is slidable along the device body by the catheter into the locked position.

15. The assembly of claim 14 wherein the device comprises a plurality of the fixation members and support members.

16. The assembly of claim 12 wherein the lock is releasable to release the fixation member from the second configuration to permit the device to be removed from the coronary sinus.

17. The asembly of claim 12 wherein the fixation member is deformable to permit the device to be moved within the coronary sinus.

18. An anchor that anchors, in a body lumen, a device having an elongated body dimensioned to be placed in the body lumen, the anchor comprising:

a fixation member carried on the device, the fixation member being adjustable from a first configuration that permits placement of the device in the body lumen to a second configuration that anchors the device within the body lumen, wherein the fixation member is elongated and has a first end hingedly coupled to the device body, wherein the fixation member extends along the device body closely spaced to the device body when in the first configuration and wherein the fixation member is pivoted from the device body when in the second configuration to engage the body lumen and anchor the device in the body lumen, wherein the fixation member includes a second end opposite the first end;

a support that renders the fixation member substantially rigid when in the second configuration, wherein the support comprises a support member having a first end hingedly coupled to the fixation member second end, wherein the support member has a second end opposite the support member first end; and

a lock that locks the fixation member in the second configuration, wherein the lock locks the support member second end on the device body.

19. The anchor of claim 18 wherein the support member second end is slidable along the device body.

20. The anchor of claim 18 comprising a plurality of the fixation members and support members.