# US 10,478,305 B2 · Steerable lesion excluding heart implants for congestive heart failure

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- Number: US 10,478,305 B2
- Document ID: US10478305B2
- Status: Granted
- Kind: B2
- Application number: 15/688,668
- Filed: 2017-08-28
- Published: 2018-03-15
- Granted: 2019-11-19
- Earliest claimed: 2005-08-19
- Assignees: BioVentrix, Inc.
- Applicants: BioVentrix, Inc.
- Inventors: Lon S. Annest; Arthur A. Bertolero; Sing-Fatt Chin; David K. Swanson
- Web page: https://patentgrep.com/patent/US10478305B2

## CPC

- A61F 2/2487: {Devices within the heart chamber, e.g. splints}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- 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)}
- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- 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)}
- 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}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00044: {Sensing electrocardiography, i.e. ECG}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/003: {Steerable}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts}
- A61B 2017/0412: {having anchoring barbs or pins extending outwardly from suture anchor body}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0462: {One way system, i.e. also tensioning the suture}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/048: {for reducing heart wall tension, e.g. sutures with a pad on each extremity}
- A61B 2017/0496: {for tensioning sutures}
- 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}
- A61B 2017/06176: {with protrusions, e.g. barbs}
- A61B 2017/22054: {with two balloons}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 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:
providing a perforation device having a distal tip that is configured to deliver electrosurgical energy to heart tissue to enable the perforation device to penetrate through the heart tissue;
penetrating, via the perforation device, the septum at a first location selected for deployment of an implant;
penetrating, via the perforation device, the wall at a second location selected for the deployment of the implant;
controllably steering the perforation device between the first location and the second location; and
deploying the implant by affixing a first anchor of the implant adjacent the penetration of the septum, affixing a second anchor of the implant adjacent the penetration of the wall, and applying tension between the first anchor and the second anchor;
wherein the tensioned members are tensioned sufficiently to bring the wall and septum into engagement, and thereby effectively exclude a region of the wall and septum from the left ventricle with scar tissue extending along the excluded region.

### Claim 2 (depends on 1)

The method of claim 1, further comprising sensing a pressure from a distal end of the perforation device advancing through the heart tissue at the first and/or second locations so as to characterize the tissue.

### Claim 3 (depends on 1)

The method of claim 1, further comprising 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 such that the implants, in combination, extend the engagement across a portion of the chamber sufficiently to exclude a plurality of regions of the wall and septum from the left ventricle with scar tissue extending along the excluded regions.

### Claim 4 (depends on 1)

The method of claim 1, further comprising engaging tissue near the first location or the second location with a probe prior to penetrating the heart tissue, 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.

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

The method of claim 1, wherein the electrosurgical energy that is delivered via the perforation device comprises electrical energy or laser energy.

### Claim 8 (depends on 1)

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, wherein the adhesions are induced to affix the septum and wall to each other.

### Claim 9 (depends on 8)

The method of claim 8, wherein treating the region of endocardium bordering the first chamber comprises subjecting the region to mechanical injury.

### Claim 10 (depends on 9)

The method of claim 9, wherein the mechanical injury is subjected on the region via application of electrical energy, laser energy, or an agent or compound.

### Claim 11 (depends on 8)

The method of claim 8, further comprising a probe having a surface that treats the endocardium to promote formation of adhesions on the heart tissue.

### Claim 12 (depends on 11)

The method of claim 11, wherein treating the endocardium to promote formation of adhesions on the heart tissue comprises:
imposing mechanical trauma via a mechanical energy application surface of the probe;
applying electrosurgical energy via an electrode surface of the probe;
applying visible or invisible radiation via a light refracting surface of the probe; or
transmitting caustic or sclerosing agents via one or more agent delivery ports of the probe.

### Claim 13 (depends on 12)

The method of claim 12, wherein the mechanical trauma is imposed via a bur.

### Claim 14 (depends on 8)

The method of claim 8, 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.

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 15)

The method of claim 15, 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.

### Claim 17 (depends on 1)

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

### Claim 18 (depends on 1)

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

### Claim 19 (depends on 1)

The method of claim 1, further comprising capturing an image of the heart 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.
