# US 10,864,014 B2 · Methods and devices for diastolic assist

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- Number: US 10,864,014 B2
- Document ID: US10864014B2
- Status: Granted
- Kind: B2
- Application number: 15/373,136
- Filed: 2016-12-08
- Published: 2017-06-15
- Granted: 2020-12-15
- Earliest claimed: 2015-12-10
- Assignees: Cordynamix, Inc.
- Applicants: Cordynamix, Inc.
- Inventors: Michael D. Laufer
- Web page: https://patentgrep.com/patent/US10864014B2

## CPC

- A61B 17/3211: Surgical scalpels, knives; Accessories therefor
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 6/487: {involving fluoroscopy}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 17/3209: Incision instruments
- A61B 2017/00044: {Sensing electrocardiography, i.e. ECG}
- A61B 2017/00243: {cardiac}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/22071: {Steering}
- A61B 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00172: {Connectors and adapters therefor}
- A61B 2018/00351: {Heart}
- A61B 2018/00589: {Coagulation}
- A61B 2018/00595: {Cauterization}
- A61B 2018/00601: {Cutting}
- A61B 2018/00827: {Current}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00892: {Voltage}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2018/1412: {Blade}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff.

## Claims

### Claim 1

A medical device for creating elongated incisions within soft tissue, the device comprising:
a handle comprising a handle body and an actuating member;
a flexible shaft having a near end coupled to the handle body and a far end;
an atraumatic tip located at the far end;
a cutting member pivotally secured within the flexible shaft and having a cutting edge;
a linking member coupling the actuating member of the handle to the cutting member, wherein when the actuating member applies a tensile force to the linking member, the cutting member pivots to a lateral side of the flexible shaft to expose the cutting edge and allow cutting of the soft tissue wherein the cutting member pivots about a pivot point that does not move axially relative to the shaft assembly, the tensile force also causing biasing of the far end of flexible shaft towards the lateral side to assist in maintaining the cutting edge within the soft tissue; and
at least one strut that extends away from the flexible shaft on a side of the shaft opposite to the cutting member, such that the strut provides a biasing to assist in maintaining the cutting edge within the soft tissue.

### Claim 2 (depends on 1)

The medical device of claim 1, further comprising a channel extending between the near end of the flexible shaft through the opening.

### Claim 3 (depends on 1)

The medical device of claim 1, where the linking member is offset from a pivot point of the cutting member.

### Claim 4 (depends on 1)

The medical device of claim 1, further comprising a sheath being slidably located on the flexible shaft, where the sheath can be advanced to cover the opening and retracted to expose the opening.

### Claim 5 (depends on 1)

The medical device of claim 1, where the cutting member comprises an electrically non-conductive material.

### Claim 6 (depends on 5)

The medical device of claim 5, further comprising at least one electrode located on the electrically non-conductive material, where the at least one electrode is electrically coupleable to a source of electrical current.

### Claim 7 (depends on 1)

The medical device of claim 1, where the cutting member comprises an electrically conductive material and where the cutting member is electrically coupleable to a source of electrical current.

### Claim 8 (depends on 1)

The medical device of claim 1, further comprising an opening adjacent to the far end of the flexible shaft, where the cutting edge of the cutting member extends through the opening when pivoted.

### Claim 9 (depends on 8)

The medical device of claim 8, further comprising an electrode adjacent to the opening.

### Claim 10 (depends on 1)

The medical device of claim 1, further comprising a rigid section at the far end of the flexible shaft where the rigid section comprises an opening through which the cutting edge of the cutting member extends when pivoted.

### Claim 11 (depends on 10)

The medical device of claim 10, where the rigid section comprises a conductive material and is coupleable to a source of current.

### Claim 12 (depends on 10)

The medical device of claim 10, where the rigid section comprises a metal enclosure.

### Claim 13 (depends on 10)

The medical device of claim 10, where the cutting member is located within the rigid section and configured to pivot.

### Claim 14 (depends on 1)

The medical device of claim 1, further comprising a strain measurement device coupled to the linking member.

### Claim 15 (depends on 1)

The medical device of claim 1, wherein the linking member is offset from an axis of the flexible shaft to assist in biasing the far end of the flexible shaft upon application of the tensile force.

### Claim 16 (depends on 1)

The medical device of claim 1, where the atraumatic tip comprises a curved elastic member.

### Claim 17 (depends on 1)

The medical device of claim 1, where the atraumatic tip is radiopaque.

### Claim 18 (depends on 1)

The medical device of claim 1, where the cutting member is releasably fixable upon pivoting to the lateral side such that the cutting member is adjustable between a range of angles relative to the flexible shaft, where the range of angles can be varied to adjust a cutting depth in the soft tissue.

### Claim 19 (depends on 18)

The medical device of claim 18, further comprising a stop coupled to the linking member, where the stop limits pivoting of the cutting member.

### Claim 20 (depends on 1)

The medical device of claim 1, where the flexible shaft further includes a braid such that to improve rotational stiffness of the flexible shaft.

### Claim 21 (depends on 1)

The medical device of claim 1, where the flexible shaft further includes a guidewire lumen.