# US 9,005,139 B2 · Device, system and method for sizing of tissue openings

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- Number: US 9,005,139 B2
- Document ID: US9005139B2
- Status: Granted
- Kind: B2
- Application number: 13/139,305
- Filed: 2009-12-02
- Published: 2011-10-06
- Granted: 2015-04-14
- Earliest claimed: 2008-12-15
- Assignees: Assis Medical Ltd.
- Applicants: Moshe Klaiman; Ran Carmeli; Itai Yonat; Eyal Teichman
- Inventors: Moshe Klaiman; Ran Carmeli; Itai Yonat; Eyal Teichman
- Web page: https://patentgrep.com/patent/US9005139B2

## CPC

- A61B 5/1076: {for measuring dimensions inside body cavities, e.g. using catheters (A61B3/1005 takes precedence)}
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/6853: {with a balloon}
- A61F 2/2496: {Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers}
- A61B 2017/22098: {Decalcification of valves}
- A61B 2562/0247: Pressure sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A device for determining a physical parameter of a tissue opening is provided. The device includes an expandable member which is designed for positioning within a tissue opening such as a valve annulus. The expandable member is capable of expanding while applying an inward radial force indicative of a diameter thereof. When the expandable member is positioned within the tissue opening and expanded, an increase in the inward radial force induced by contact between the expandable member and tissue surrounding the opening can be utilized to derive information relating to the physical parameter of the tissue opening.

## Claims

### Claim 1

A device for determining a physical parameter of a tissue opening comprising a catheter having a semi-compliant expandable member including a non-compliant inflatable balloon at least partially covered by an elastic cage configured having a wire mesh, a wire spiral or wire struts, said elastic cage anchored to distal and proximal ends of said balloon, said expandable member being capable of expanding while applying an inward radial force indicative of a diameter thereof, such that when said expandable member is positioned within a tissue opening and expanded, an increase in said inward radial force can be indicative of contact between said expandable member and tissue surrounding the tissue opening.

### Claim 2 (depends on 1)

The device of claim 1, wherein said increase in said inward radial force can be utilized to derive information relating to the physical parameter of the tissue opening.

### Claim 3 (depends on 1)

The device of claim 1, wherein the tissue opening is a valve annulus.

### Claim 4 (depends on 1)

The device of claim 1, wherein said expandable member has an elastic diameter range of 4-35 mm.

### Claim 5 (depends on 1)

The device of claim 1, wherein said physical parameter is a diameter of the tissue opening.

### Claim 6 (depends on 1)

The device of claim 1, further comprising a plurality of imaging markers attached to said expandable member.

### Claim 7 (depends on 6)

The device of claim 6, wherein said plurality of imaging markers are arranged in a pattern selected for indicating a cross sectional shape of said expandable member when in an expanded state.

### Claim 8 (depends on 1)

The device of claim 1, wherein said cage is capable of elastic expansion without substantial structural deformation when expanded beyond a tissue contact diameter within the tissue opening.

### Claim 9

A method of sizing a tissue opening comprising (a) inflating a semi-compliant expandable member disposed on a catheter within said tissue opening, said expandable member including a non-compliant balloon positioned within an elastic cage anchored to distal and proximal ends of said inflatable balloon; (b) measuring volume and pressure of said inflatable structure during said inflation; and (c) utilizing said volume and pressure measurements to determine a point of contact between said expandable member and tissue of the tissue opening to thereby size the tissue opening.

### Claim 10 (depends on 9)

The method of claim 9, wherein the tissue opening is a valve annulus.