# US 12,408,966 B2 · Systems and methods for treating pyronies disease

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- Number: US 12,408,966 B2
- Document ID: US12408966B2
- Status: Granted
- Kind: B2
- Application number: 17/647,680
- Filed: 2022-01-11
- Published: 2022-07-14
- Granted: 2025-09-09
- Earliest claimed: 2021-01-11
- Assignees: Kemeny Healthcare Inc.
- Applicants: Kemeny Healthcare Inc.
- Inventors: Csaba Truckai
- Web page: https://patentgrep.com/patent/US12408966B2

## CPC

- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 2017/00792: {Plastic surgery}
- A61B 2017/3413: {guided by ultrasound}
- A61B 2018/00005: {Cooling or heating of the probe or tissue immediately surrounding the probe}
- A61B 2018/00315: {for treatment of particular body parts}
- A61B 2018/00547: {Prostate}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00714: {Temperature}
- A61B 2018/00791: {Temperature}
- A61B 2018/0293: {using an instrument interstitially inserted into the body, e.g. needle}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2090/0418: {Compensation}
- A61B 2090/0463: {against cooling or freezing}
- A61B 2090/378: {using ultrasound}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices and methods, and for remodeling tissues to treat Peyronie's disease including devices and methods adapted for cryogenic cooling of targeted plaque in a male penis to selectively remodel targeted tissue.

## Claims

### Claim 1

A method for cryogenically treating Peyronie's disease, comprising:
providing a cryogenic device including at least one tissue-penetrating needle with a cooling tip;
advancing the cooling tip into plaque in a subject's penile shaft; and
cooling the plaque with the cooling tip thereby inducing a cooling injury to the plaque to achieve a therapeutic effect by reducing curvature of the penile shaft.

### Claim 2 (depends on 1)

The method of claim 1, wherein cooling the plaque with the cooling tip maintains the cooling tip at a targeted cooling temperature for at least 5 seconds.

### Claim 3 (depends on 2)

The method of claim 2, wherein cooling the plaque with the cooling tip comprises cooling to a targeted cooling temperature lower than −10 degrees Celsius.

### Claim 4 (depends on 2)

The method of claim 2, wherein the targeted cooling temperature is between −10 and −80 degrees Celsius.

### Claim 5 (depends on 1)

The method of claim 1, wherein cooling the plaque with the cooling tip includes maintaining the cooling tip in a stationary position in the plaque.

### Claim 6 (depends on 1)

The method of claim 1, wherein cooling the plaque includes moving the cooling tip in the plaque.

### Claim 7 (depends on 1)

The method of claim 1, wherein the therapeutic effect comprises the plaque being absorbed by a body of a patient.

### Claim 8 (depends on 1)

The method of claim 1, further comprising imaging the plaque to provide a 3-dimensional map of the plaque.

### Claim 9 (depends on 8)

The method of claim 8, wherein imaging the plaque is performed with an ultrasound device.

### Claim 10 (depends on 8)

The method of claim 8, further comprising imaging during advancing the cooling tip.

### Claim 11 (depends on 8)

The method of claim 8, further comprising imaging during cooling the plaque.

### Claim 12 (depends on 8)

The method of claim 8, further comprising imaging with an ultrasound device.

### Claim 13 (depends on 12)

The method of claim 12, further comprising a controller operatively coupled to the cryogenic device and the ultrasound device.

### Claim 14 (depends on 13)

The method of claim 13, wherein the controller is configured to modulate cooling the plaque in response to imaging signals from the ultrasound device.

### Claim 15 (depends on 14)

The method of claim 14, wherein the controller is configured to (i) record a 3-dimensional map of the plaque provided by the ultrasound device, (ii) monitor location of one or more cooling tips within the plaque with the ultrasound device; and (iii) actuate the cryogenic device to cool the plaque; and (iv) terminate cooling with the cryogenic device in response imaging with the ultrasound device.

### Claim 16 (depends on 15)

The method of claim 15, further comprising a warming system with at least one warming needle with a warming tip and introducing a warming tip into tissue adjacent the plaque.

### Claim 17 (depends on 16)

The method of claim 16, further comprising warming an adjacent tissue with the warming tip to thereby prevent a cooling injury to the adjacent tissue.

### Claim 18 (depends on 17)

The method of claim 17, wherein warming is performed prior to cooling the plaque, contemporaneous with cooling the plaque, and/or after cooling the plaque.

### Claim 19 (depends on 18)

The method of claim 18, wherein the warming tip is operatively coupled to the controller and the controller is configured to modulate warming the adjacent tissue.

### Claim 20 (depends on 18)

The method of claim 18, wherein the warming the adjacent tissue is modulated in response to signals from a temperature sensor carried by the warming tip.