# US 11,076,825 B2 · Surgical instrument to assess tissue characteristics

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- Number: US 11,076,825 B2
- Document ID: US11076825B2
- Status: Granted
- Kind: B2
- Application number: 16/170,503
- Filed: 2018-10-25
- Published: 2019-02-28
- Granted: 2021-08-03
- Earliest claimed: 2006-02-17
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Jeffrey H. Nycz; Fred J. Molz, IV; Steven Tethrake; Stanley Warren Olson, Jr.; William T. Donofrio
- Web page: https://patentgrep.com/patent/US11076825B2

## CPC

- A61B 8/0875: {for diagnosis of bone}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/4483: {characterised by features of the ultrasound transducer}
- A61B 8/483: {involving the acquisition of a 3D volume of data}
- A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)}
- A61B 17/1703: {using imaging means, e.g. by X-rays}
- A61B 17/8805: {for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence)}
- A61B 5/4504: {Bones (A61B5/4547 takes precedence)}
- A61B 5/4509: {Bone density determination}
- A61B 8/4245: {involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient}
- A61B 8/4472: {Wireless probes}
- A61B 17/56: Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A surgical instrument for assessing tissue characteristics such as tissue density and volume is disclosed. The surgical instrument is hand-held and includes transducers adapted for emitting and/or receiving acoustic signals. The surgical instrument utilizes pulse-echo to determine tissue characteristics. The surgical instrument may be utilized to determine such things as the size of a lesion and whether the lesion has been completely removed or filled with graft material.

## Claims

### Claim 1

A method of treating osteoporosis in a bone tissue, comprising:
placing a hand-held device at least proximate a surface of the bone tissue, the hand-held device comprising multiple emitting transducers, a dedicated receiving transducer, and a processor, each of the multiple emitting transducers being configured for emitting at least one acoustic signal into the bone tissue, and the dedicated receiving transducer being configured for receiving an echo corresponding to each of the at least one acoustic signals;
emitting, by each of the multiple emitting transducers, the at least one acoustic signal into the bone tissue, each of the at least one acoustic signal being reflected by a boundary of an osteoporotic region of the bone tissue as an echo;
detecting, by the dedicated receiving transducer, each of the echoes corresponding to each of the at least one acoustic signals;
determining, by the processor, a time delay for each of the detected echoes;
determining, by the processor, boundaries of the osteoporotic region by calculating depths thereof based on the determining of the time delays and assumed speeds for each of the at least one acoustic signals;
determining a location of the osteoporotic region in the bone tissue using the determined boundaries;
determining, by the processor, an approximate volume of the osteoporotic region based on the determined boundaries of the osteoporotic region and comparing the determined boundaries to one or more geometric shapes of known volume; and
utilizing the location and the approximate volume of the osteoporotic region to guide a surgical instrument to the osteoporotic region.

### Claim 2 (depends on 1)

The method of claim 1, further comprising delivering at least one of autograft, allograft, osteoconductive material, osteoinductive material, and bone morphogenic protein via the surgical instrument to the osteoporotic region.

### Claim 3 (depends on 1)

The method of claim 1, wherein each of the multiple emitting transducers is configured to emit the at least one acoustic signal at at least one of a plurality of different frequencies.

### Claim 4 (depends on 3)

The method of claim 3, wherein the plurality of different frequencies include frequencies in a range between 15 KHz and 100 MHz.

### Claim 5 (depends on 3)

The method of claim 3, wherein the plurality of different frequencies include frequencies in a range between 20 KHz to approximately 20 MHz.

### Claim 6 (depends on 1)

The method of claim 1, wherein the hand-held device includes a body portion having a first end and an opposite second end, and the multiple emitting transducers are provided at the first end.

### Claim 7 (depends on 6)

The method of claim 6, wherein the first end of the body portion includes a conductive surface formed as a disposable sheath; and the method further comprising replacing the disposable sheath after each use of the hand-held device.

### Claim 8

A method of treating osteoporosis in a bone tissue, comprising:
placing a hand-held device at least proximate a surface of the bone tissue, the hand-held device comprising multiple emitting transducers, a dedicated receiving transducer, and a processor;
emitting, by each of the multiple emitting transducers, at least one acoustic signal into the bone tissue;
detecting, by the dedicated receiving transducer, an echo reflected by a boundary of an osteoporotic region of the bone tissue as an echo corresponding to each of the at least one acoustic signals;
determining, by the processor, a time delay for each of the detected echoes;
determining, by the processor, boundaries of the osteoporotic region by calculating depths thereof based on the determining of the time delays and assumed speeds for each of the at least one acoustic signals;
determining a location of the osteoporotic region in the bone tissue using the determined boundaries;
determining, by the processor, an approximate volume of the osteoporotic region based on the determined boundaries of the osteoporotic region and comparing the determined boundaries to one or more geometric shapes of known volume; and
utilizing the location and the approximate volume of the osteoporotic region to guide a surgical instrument to the osteoporotic region.

### Claim 9 (depends on 8)

The method of claim 8, further comprising delivering at least one of autograft, allograft, osteoconductive material, osteoinductive material, and bone morphogenic protein via the surgical instrument to the osteoporotic region.

### Claim 10 (depends on 8)

The method of claim 8, wherein each of the emitting transducers is configured to emit the at least one acoustic signal at at least one of a plurality of different frequencies.

### Claim 11 (depends on 10)

The method of claim 10, wherein the plurality of different frequencies include frequencies in a range between 15 KHz and 100 MHz.

### Claim 12 (depends on 10)

The method of claim 10, wherein the plurality of different frequencies include frequencies in a range between 20 KHz to approximately 20 MHz.

### Claim 13 (depends on 8)

The method of claim 8, wherein the hand-held device includes a body portion having a first end and an opposite second end, and the multiple emitting transducers are provided at the first end.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first end of the body portion includes a conductive surface formed as a disposable sheath; and the method further comprising replacing the disposable sheath after each use of the hand-held device.

### Claim 15

A method of treating osteoporosis in a bone tissue, comprising:
emitting, by each of multiple emitting transducers, at least one acoustic signal into the bone tissue;
detecting, by a dedicated receiving transducer, an echo reflected by a boundary of an osteoporotic region of the bone tissue as an echo corresponding to each of the at least one acoustic signals;
determining, by a processor, a time delay for each of the detected echoes;
determining, by the processor, boundaries of the osteoporotic region by calculating depths thereof based on the determining of the time delays and assumed speeds for each of the at least one acoustic signals;
determining a location of the osteoporotic region in the bone tissue using the determined boundaries;
determining, by the processor, an approximate volume of the osteoporotic region based on the determined boundaries of the osteoporotic region and comparing the determined boundaries to one or more geometric shapes of known volume; and
utilizing the location and the approximate volume of the osteoporotic region to guide a surgical instrument to the osteoporotic region.

### Claim 16 (depends on 15)

The method of claim 15, further comprising delivering at least one of autograft, allograft, osteoconductive material, osteoinductive material, and bone morphogenic protein via the surgical instrument to the osteoporotic region.

### Claim 17 (depends on 15)

The method of claim 15, wherein each of the emitting transducers is configured to emit the at least one acoustic signal at at least one of a plurality of different frequencies.

### Claim 18 (depends on 17)

The method of claim 17, wherein the plurality of different frequencies include frequencies in a range between 15 KHz and 100 MHz.

### Claim 19 (depends on 17)

The method of claim 17, wherein the plurality of different frequencies include frequencies in a range between 20 KHz to approximately 20 MHz.

### Claim 20 (depends on 15)

The method of claim 15, wherein the multiple emitting transducers and the dedicated receiving transducer are part of an electronic instrument, the electronic instrument having a body portion including a first end and an opposite second end, the multiple emitting transducers are provided at the first end.
