Steerable lesion excluding heart implants for congestive heart failure

• US 9,402,722 B2
• Filed: 05/27/2015
• Issued: 08/02/2016
• Est. Priority Date: 08/19/2005
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Bertolero, Arthur A., Chin, Sing-Fatt, Swanson, David K.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/723,187
• Publication Number:
  US 20160022422A1
• Time in Patent Office: 433 Days
• Field of Search: 600 16- 18
• US Class Current: 1/1
• 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 17/0401 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 17/0487 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• 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 2017/0496 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
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/22054 : with two balloons
• CPC Class Codes: A61B 2017/22069 : Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints

Abstract

Devices, systems, and methods for treating a heart of a patient may make use of one or more implant structures which limit a size of a chamber of the heart, such as by deploying a tensile member to bring a wall of the heart toward (optionally into contact with) a septum of the heart.

Claims

1. A method for treating a heart, the heart having a first chamber bordered by a septum and a wall, wherein the chamber comprises a left ventricle of the heart, the heart having a second chamber separated from the first chamber by the septum, the method comprising:

penetrating the septum at a first location;

penetrating the wall at a second location;

penetrating the wall at a third location that is laterally offset from the second location;

affixing a first anchor adjacent the penetration of the septum;

affixing a second anchor adjacent the penetration of the wall at the second location, wherein a first tension member extends from the first anchor to the second anchor and tensionalby couples the first anchor and the second anchor;

affixing a third anchor adjacent the penetration of the wall at the third location, wherein a second tension member extends from the first anchor to the third anchor and tensionalby couples the first anchor and the third anchor such that a plurality of anchors positioned adjacent the wall are tensionably coupled with the first anchor;

applying tension between the first anchor, the second anchor, and the third anchor by tensioning the first tension member and the second tension member so that tension is applied between the septum and the wall;

wherein the first anchor, the second anchor, and the third anchor are tensioned sufficiently to bring the wall and septum into engagement, and wherein the second and third anchors are separated so as to, in combination, extend the engagement across a portion of the wall sufficiently to effectively exclude regions of the wall and septum from the left ventricle with scar tissue extending along the excluded regions.

2. The method of claim 1, wherein the third anchor is angularly offset from the second anchor.

3. The method of claim 1, further comprising engaging tissue near the first location or the second location with a probe to characterize the engaged tissue with the probe.

4. The method of claim 3, wherein the engaged tissue is characterized by pacing the engaged tissue with an electrode of the probe.

5. The method of claim 1, wherein the anchors are affixed by radially expanding the anchors and engaging axially-oriented surfaces of the anchors with tissue adjacent the perforations.

6. The method of claim 1, wherein at least one of the anchors comprises a plurality of arms that are deployable against the surface of the septum or wall.

7. The method of claim 1, further comprising inducing adhesions between the wall and the septum by treating a region of endocardium bordering the first chamber, the tension being applied so as to approximate the wall and the septum along the endocardium region.

8. A method for treating a heart, the heart having a first chamber bordered by a septum and a wall, wherein the chamber comprises a left ventricle of the heart, the heart having a second chamber separated from the first chamber by the septum, the method comprising:

penetrating the septum;

penetrating the wall at a first location;

penetrating the wall at a second location that is laterally offset from the first location;

affixing a septal anchor adjacent the penetration of the septum;

affixing a first wall anchor adjacent the penetration of the wall at the first location, wherein a first tension member extends from the septal anchor to the first wall anchor;

affixing a second wall anchor adjacent the penetration of the wall at the second location, wherein a second tension member extends from the septal anchor to the second wall anchor;

applying tension between the septal anchor and the first and second wall anchors via the first and second tension members to apply tension to the septum and the wall.

9. The method of claim 8, wherein the second wall anchor is angularly offset from the first wall anchor.

10. The method of claim 8, further comprising engaging tissue near the septum or the wall with a probe to characterize the engaged tissue with the probe.

11. The method of claim 10, wherein the engaged tissue is characterized by pacing the engaged tissue with an electrode of the probe.

12. The method of claim 8, wherein the septal anchor, first wall anchor, and second wall anchor are affixed by radially expanding said anchors and engaging axially-oriented surfaces of the anchors with tissue adjacent the perforations.

13. The method of claim 8, wherein at least one of the septal anchor, first wall anchor, or second wall anchor comprises a plurality of arms that are deployable against the surface of the septum or wall.

14. The method of claim 8, further comprising inducing adhesions between the wall and the septum by treating a region of endocardium bordering the first chamber, the tension being applied so as to approximate the wall and the septum along the endocardium region.

15. A method for treating a heart, the heart having a first chamber bordered by a first wall and a second wall, the method comprising:

penetrating the first wall;

penetrating the second wall at a first location;

penetrating the second wall at a second location that is laterally offset from the first location;

affixing a first anchor adjacent the penetration of the first wall;

affixing a second anchor adjacent the penetration of the second wall at the first location;

coupling a first tension member with the first anchor and the second anchor, the first tension member being tensionable to apply tension to the first wall and the second wall at the first location via the first anchor and the second anchor;

affixing a third anchor adjacent the penetration of the second wall at the second location; and

coupling a second tension member with the first anchor and the third anchor, the second tension member being tensionable to apply tension to the first wall and the second wall at the second location via the first anchor and the third anchor.

16. The method of claim 15, wherein the third anchor is angularly offset from the second anchor.

17. The method of claim 15, further comprising engaging tissue near the first wall or the second wall with a probe to characterize the engaged tissue with the probe.

18. The method of claim 17, wherein the engaged tissue is characterized by pacing the engaged tissue with an electrode of the probe.

19. The method of claim 15, wherein the first anchor, second anchor, and third anchor are affixed by radially expanding said anchors and engaging axially-oriented surfaces of the anchors with tissue adjacent the perforations.

20. The method of claim 15, wherein at least one of the first anchor, second anchor, or third anchor comprises a plurality of arms that are deployable against the surface of the first wall or second wall.