Treating dysfunctional cardiac tissue

• US 8,968,175 B2
• Filed: 07/23/2013
• Issued: 03/03/2015
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Argento, Claudio, Butler, William, Heflin, Ernest
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/949,025
• Publication Number:
  US 20140031613A1
• Time in Patent Office: 588 Days
• Field of Search: 600 16- 17, 600/37
• US Class Current: 600/16
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Claims

1. A kit for treating a heart of a patient comprising:

a plurality of curved hollow bore insertion needles configured for penetrating first and second heart walls bordering a chamber of the heart, wherein each of the insertion needles includes a sharp distal tip that is aligned with an axis of a proximal straight portion and a distal portion that is curved, the curved distal portion enabling the sharp distal tip to penetrate the first heart wall at an angle and to penetrate the second heart wall at an angle as the respective insertion needle is advance through the heart, and wherein a radius of curvature of the curved distal portion of each of the insertion needles is different to provide different ranges for ventricular reshaping;

an introducer having a proximal end and a distal end with a shaft therebetween, the distal end insertable along an insertion path through the first and second heart walls bordering the chamber of the heart;

a first anchor, the first anchor being axially translatable along the path of the introducer through the heart walls; and

an elongate member extendable proximally from the first anchor and rotationally coupled to the first anchor so as to enable axial rotation of the first anchor from proximally of the heart walls and to orient an arm of the anchor along a lateral orientation corresponding to a contour of the heart.

2. The kit of claim 1, wherein the first anchor comprises an arm structure pivotally coupled to the elongate member so as to pivot from an insertion configuration to a deployed configuration, the arm structure in the deployed configuration defining first and second arms extendable from the elongate member with the first arm extending along a first orientation and the second arm extending opposite the first orientation, and the arm structure in the insertion configuration extending along an axis of the elongate member with the first arm extending proximally and the second arm extending distally of a distal end of the elongate member.

3. The kit of claim 1, wherein the elongate member comprises a tension member extending proximally from an elongate shaft of the first anchor, the elongate shaft pivotally coupled to the arm structure.

4. The kit of claim 1, wherein the elongate member comprises a tether having a plurality of axially repeating features, each of the repeating features comprising at least one of a protrusion, barb, or pawl.

5. The kit of claim 2, wherein the arm structure is connected to the elongate member through a flexible joint.

6. The kit of claim 1, further comprising a second anchor, wherein the second anchor comprises a locking mechanism operatively engageable with the elongate member so as to allow axial movement of the anchors toward each other, and so as to inhibit axial movement of the anchors away from each other.

7. The kit of claim 1, further comprising a second anchor and a third anchor, each anchor having an associated elongate member tensionable so as to compress the walls together between the anchor and an associated opposing anchor, the first, second, and third anchors each rotatable about axes of the associated elongate members so as to align arms of the anchors along a desired wall contact contour from proximally of the walls of the heart.

8. The kit of claim 1, wherein each curved distal portion of each of the insertion needles is configured to accommodate a different range of separation distances between a first penetration point of the first heart wall and a second penetration point of the second heart wall.

9. A kit for treating a heart of a patient, comprising:

a plurality of curved guidewire introducers having a hollow bore through which a guidewire is insertable, each guidewire introducer being configured for insertion through first and second heart walls bordering a chamber of the heart, wherein each of the guidewire introducers includes a sharp distal tip that is aligned with an axis of a proximal straight portion and a distal portion that is curved, the curved distal portion enabling the sharp distal tip to penetrate the first heart wall at an angle and to penetrate the second heart wall at an angle as the respective guidewire introducer is advance through the heart, and wherein a radius of curvature of the curved distal portion of each of the guidewire introducers is different to provide different ranges for ventricular reshaping;

an introducer catheter having a proximal end and a distal end with a shaft therebetween, the distal end being insertable along an insertion path through the first and second heart walls bordering the chamber of the heart;

a first anchor, the first anchor being axially translatable along the path of the introducer catheter through the heart walls; and

an elongate member extendable proximally from the first anchor and rotationally coupled to the first anchor so as to enable axial rotation of the first anchor from proximally of the heart walls and to orient an arm of the anchor along a lateral orientation corresponding to a contour of the heart.

10. The kit of claim 9, further comprising a dilation member having a tapered distal end that is configured to dilate a perforation in the first and/or second heart walls as the dilation member is advanced through the perforation.

11. The kit of claim 9, further comprising an expansion member, the expansion member being expandable within a chamber of the heart and moveable therein to urge the second heart wall toward the first hear wall.

12. The kit of claim 9, wherein the first anchor comprises an arm structure pivotally coupled to the elongate member so as to pivot from an insertion configuration to a deployed configuration.

13. The kit of claim 12, further comprising a second anchor, wherein the second anchor comprises a locking mechanism operatively engageable with the elongate member so as to allow axial movement of the anchors toward each other, and so as to inhibit axial movement of the anchors away from each other.

14. An assembly of surgical instruments comprising:

a plurality of curved insertion needles that are each configured for insertion through first and second heart walls bordering a chamber of the heart, wherein each of the insertion needles includes a sharp distal tip that is aligned with an axis of a proximal straight portion and a distal portion that is curved, the curved distal portion enabling the sharp distal tip to penetrate the first heart wall at an angle and to penetrate the second heart wall at an angle as the respective insertion needle is advance through the heart, and wherein a radius of curvature of the curved distal portion of each of the insertion needles is different to provide different ranges for ventricular reshaping;

an introducer catheter having a proximal end and a distal end with a shaft therebetween, the distal end being insertable through the first and second heart walls;

a first anchor, the first anchor being axially translatable along a path of the introducer catheter through the heart walls;

a tension member extendable proximally from the first anchor; and

a second anchor, the second anchor including a locking mechanism that is operatively engageable with the tension member to allow axial movement of the first and second anchors toward each other and to inhibit axial movement of the first and second anchors away from each other.

15. The assembly of claim 14, wherein each insertion needle includes a hollow bore through which a guidewire is insertable.

16. The assembly of claim 14, wherein the tension member is rotationally coupled to the first anchor so as to axially rotate the first anchor from proximally of the heart walls and to orient an arm of the anchor along a desired lateral orientation.

17. The assembly of claim 14, further comprising a dilation member having a tapered distal end that is configured to dilate a perforation in the first and/or second heart walls as the dilation member is advanced through the perforation.

18. The assembly of claim 14, further comprising an expansion member, the expansion member being expandable within a chamber of the heart to urge the first and second heart walls toward one another.

19. The assembly of claim 14, wherein the first anchor comprises an arm structure pivotally coupled to the tension member so as to pivot from an insertion configuration to a deployed configuration.