Steerable lesion excluding heart implants for congestive heart failure

• US 9,044,231 B2
• Filed: 03/11/2013
• Issued: 06/02/2015
• 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:
  US13/794,096
• Publication Number:
  US 20130325041A1
• Time in Patent Office: 813 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 for prostheses A61F2210/0014
• 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 hollow suture needles A61B2017/061
• 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:

imaging the first chamber of the heart to select locations for deployment of a plurality of implants relative to the septum and the wall, the locations being selected so that upon engagement of the wall and septum, an arrangement of the deployed implants approximates the shape of a healthy heart chamber and avoids formation of excessive thrombus-accumulating voids;

characterizing via the image of the first chamber, the tissue of the selected locations as comprising scar tissue or viable contractile tissue;

penetrating the septum at a first location selected for deployment of a first implant;

penetrating the wall at a second location selected for the deployment of the first implant;

controllably steering between the first location and the second location with reference to the image of the first chamber;

deploying the first implant by affixing a first anchor of the first implant adjacent the penetration of the septum, affixing a second anchor of the first implant adjacent the penetration of the wall, and applying tension between the first anchor and the second anchor; and

penetrating the wall at a plurality of additional locations, wherein a plurality of separate implants are deployed, each deployed implant having a tension member extending from a first anchor at an associated penetration of the septum to a second anchor at an associated penetration of the wall so that the tension members are laterally offset, wherein tension is applied between the septum and the wall by the laterally offset tension members of the implants;

wherein the tensioned members are tensioned sufficiently to bring the wall and septum into engagement, and wherein the tension members, the anchors, and associated penetrations are separated so as to, in combination, extend the engagement across a portion of the chamber 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, further comprising engaging tissue near the first location or the second location with a probe, characterizing the engaged tissue with the probe, and repositioning the probe from the characterized tissue to the first location or the second location for penetration.

3. The method of claim 2, wherein the engaged tissue is characterized by pacing the engaged tissue with an electrode of the probe.

4. 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.

5. The method of claim 4, wherein at least one of the anchors comprises a plurality of arms defined by axial cuts in a tube, wherein radial expansion of the anchors comprises bending the arms radially outwardly with the axially-oriented surface comprising a first portion of each arm and being supported by a longer angled portion of the arm.

6. The method of claim 4, further comprising supporting the axially-oriented surface by introducing a fluid into the anchor, the fluid being restrained by a bladder material.

7. The method of claim 6, wherein the fluid hardens within the anchor.

8. The method of claim 1, further comprising releasing a bioactive material from the implant.

9. The method of claim 8, wherein the bioactive material comprises an elutable drug.

10. 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.

11. The method of claim 10, wherein at least a portion of the implant biodegrades or is removed so that the adhesions restrain a size of the first chamber and effectively exclude scar tissue from the first chamber.

12. The method of claim 1, wherein the tension is applied between the anchors by decreasing a length of a tension member extending between the anchors.

13. The method of claim 12, wherein the decreasing length of the tension member between the anchors results in a portion of the tension member extending through the wall and remaining in an extra-cardiac space.

14. The method of claim 1, further comprising inflating a balloon adjacent the perforation of the wall so as to inhibit bloodflow through the perforation.

15. The method of claim 1, wherein at least a portion of the implant is deployed by accessing the epicardial surface from outside the heart.

16. The method of claim 1, further comprising capturing the image using at least one of intra cardiac echocardiography, extra cardiac echocardiography, endoscopy, or fluoroscopy, and wherein the implant or delivery system components associated therewith provide high-contrasts within the image.

19. The method of claim 1, further comprising engaging tissue near the first location or the second location with a probe to verify that the first location or the second location comprises scar tissue or is otherwise suitable for penetration.

17. A system for treating a heart, the heart having a first chamber bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the system comprising:

an imaging device that is configured to image the first chamber of the heart so as to characterize scar tissue and viable contractile tissue of the first chamber for selecting deployment locations for implants that approximate the shape of a healthy heart chamber and avoids formation of excessive thrombus-accumulating voids;

a perforation device advanceable through the septum and/or wall and having a probe disposed at a distal end thereof that is configured to verify that engaged tissue of the septum and/or wall at the selected deployment locations comprises scar tissue or is otherwise suitable for penetration; and

a plurality of separate implants, each implant having an anchor, a wall anchor, and a tension member to apply tension between the septum and wall when the implant is deployed at one of the selected deployment locations so as to bring the wall and septum into engagement, the implants together configured to extend the engagement across a portion of the chamber sufficiently to effectively exclude regions of the wall and septum from the chamber when adjacent anchors are separated along the septum and wall.

18. A system for treating a heart, the heart having a first chamber bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the system comprising:

an implant having an anchor, a wall anchor, and a tension member to apply tension between the septum and wall when the implant is deployed so as to bring the wall and septum into engagement;

at least one additional implant, the at least one additional implant being deployable separated from the first implant;

means for imaging the first chamber of the heart so as to characterize scar tissue and viable contractile tissue of the first chamber;

means for penetrating the wall of the heart and the septum from a surgical site outside the heart and within the patient;

means for directing the penetrating means to form a plurality of penetrations through the wall and the septum and at locations separated across a lower portion of the chamber so that the implants, when deployed, are separated from each other and form a region of engagement extending across the lower portion of the chamber; and

means for sensing pressure within the heart, the pressure sensing means coupled to the penetrating means.