# US 11,077,318 B2 · System and process of utilizing energy for treating biological tissue

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- Number: US 11,077,318 B2
- Document ID: US11077318B2
- Status: Granted
- Kind: B2
- Application number: 16/039,779
- Filed: 2018-07-19
- Published: 2018-11-29
- Granted: 2021-08-03
- Earliest claimed: 2012-05-25
- Assignees: Ojai Retinal Technology, LLC
- Applicants: Ojai Retinal Technology, LLC
- Inventors: Jeffrey K. Luttrull; David B. Chang; Benjamin W. L. Margolis
- Web page: https://patentgrep.com/patent/US11077318B2

## CPC

- A61N 5/0603: {for treatment of body cavities}
- A61B 18/1206: {Generators therefor}
- A61B 18/14: Probes or electrodes therefor
- A61F 9/00817: {Beam shaping with masks}
- A61F 9/00821: {for coagulation}
- A61N 5/025: {Warming the body, e.g. hyperthermia treatment}
- A61N 5/045: {specially adapted for treatment inside the body}
- A61N 5/0625: {Warming the body, e.g. hyperthermia treatment}
- A61N 7/022: {intracavitary}
- A61B 2018/00005: {Cooling or heating of the probe or tissue immediately surrounding the probe}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61F 2009/00863: {Retina}
- A61N 1/403: {for thermotherapy, e.g. hyperthermia}
- A61N 5/067: using laser light
- A61N 2005/0604: {Lungs and/or airways}
- A61N 2005/0608: {Rectum}
- A61N 2005/0609: {Stomach and/or esophagus}
- A61N 2005/063: {comprising light transmitting means, e.g. optical fibres}
- A61N 2005/0651: {Diodes}
- A61N 2005/0659: {infrared}
- A61N 2005/0662: {Visible light}
- A61N 2007/0043: {intra-cavitary}
- 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)
- 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 process for heat treating biological tissue includes providing a plurality of energy emitters formed into an array. Treatment energy is generated from the plurality of emitters and applied to target tissue. The treatment energy has energy and application parameters selected so as to raise the target tissue temperature sufficiently to create a therapeutic effect while maintaining an average temperature of the target tissue over several minutes at or below a predetermined temperature so as not to destroy or permanently damage the target tissue.

## Claims

### Claim 1

A process for heat treating biological tissue, comprising the steps of:
providing a plurality of energy emitters formed into an array;
generating treatment energy from the plurality of emitters;
providing an initial treatment to target tissue by repeatedly applying the energy to the target tissue in a pulsed manner for the exposure duration comprising less than one second;
halting application of the pulsed energy to the target tissue for an interval of time comprising between three seconds and three minutes; and
providing a secondary treatment to the target tissue after the interval of time, within a single treatment session, by repeatedly reapplying the pulsed energy for the exposure duration comprising less than one second
wherein the treatment energy has energy and application parameters selected so as to raise the target tissue temperature sufficiently to create a therapeutic effect while maintaining an average temperature of the target tissue over several minutes at or below a predetermined temperature so as to not destroy or permanently damage the target tissue.

### Claim 2 (depends on 1)

The process of claim 1, wherein the selected energy and application parameters comprise tissue application spot size or area, average power or average power density, and exposure duration.

### Claim 3 (depends on 1)

The process of claim 1, wherein during an interval of time, comprising less than one second, between applications of energy applied to a first area of the target tissue, applying treatment energy to a second area of the target tissue sufficiently spaced apart from the first area of the target tissue to avoid thermal tissue damage of the target tissue.

### Claim 4 (depends on 3)

The process of claim 3, wherein repeatedly applying, in an alternating manner during the same treatment session, the treatment energy to each of the first and second areas of the target tissue until a predetermined number of energy applications to each of the first and second areas of the target tissue has been achieved.

### Claim 5 (depends on 3)

The process of claim 3, including the step of introducing a phase delay in the activation of the energy emitters of the array to generate treatment energy in a phased manner using a predetermined delay of activation in order to apply treatment energy to each of the first and second areas of the target tissue.

### Claim 6 (depends on 3)

The process of claim 3, including the step of activating the energy emitters of the array sequentially in order to apply treatment energy to each of the first and second areas of the target tissue.

### Claim 7 (depends on 1)

The process of claim 1, wherein the treatment energy raises the target tissue to up to eleven degrees Celsius at least during application of the pulsed treatment energy thereto.

### Claim 8 (depends on 1)

The process of claim 1, wherein the average target tissue temperature is maintained at six degrees Celsius or less over several minutes.

### Claim 9 (depends on 8)

The process of claim 8, wherein the average target tissue temperature is maintained at one degree Celsius or less over several minutes.

### Claim 10 (depends on 1)

The process of claim 1, wherein the applying step comprises the step of stimulating heat shock protein activation in the target tissue.

### Claim 11 (depends on 1)

The process of claim 1, wherein the treatment energy comprises light energy, radio frequency energy, microwave energy or ultrasound energy.

### Claim 12 (depends on 11)

The process of claim 11, wherein the treatment energy comprises a radio frequency between approximately three to six megahertz, a duty cycle of between approximately 2.5% and 5%.

### Claim 13 (depends on 12)

The process of claim 12, wherein the radio frequency is generated with coils having a radii between approximately 2 mm and 10 cm and between approximately 13 and 57 amp turns.

### Claim 14

A process for heat treating biological tissue, comprising the steps of:
providing a plurality of energy emitters formed into an array;
generating treatment energy from the plurality of emitters; and
applying the treatment energy to target tissue;
wherein the treatment energy has energy and application parameters selected so as to raise the target tissue temperature sufficiently to create a therapeutic effect while maintaining an average temperature of the target tissue over several minutes at or below a predetermined temperature so as to not destroy or permanently damage the target tissue; and
wherein during an interval of time, comprising less than one second, between applications of energy applied to a first area of the target tissue, applying treatment energy to a second area of the target tissue sufficiently spaced apart from the first area of the target tissue to avoid thermal tissue damage of the target tissue; and
including the step of introducing a phase delay in the activation of the energy emitters of the array to generate treatment energy in a phased manner using a predetermined delay of activation in order to apply treatment energy to each of the first and second areas of the target tissue.

### Claim 15 (depends on 14)

The process of claim 14, wherein the selected energy and application parameters comprise tissue application spot size or area, average power or average power density, and exposure duration.

### Claim 16 (depends on 14)

The process of claim 14, wherein repeatedly applying, in an alternating manner during the same treatment session, the treatment energy to each of the first and second areas of the target tissue until a predetermined number of energy applications to each of the first and second areas of the target tissue has been achieved.

### Claim 17 (depends on 14)

The process of claim 14, including the step of activating the energy emitters of the array sequentially in order to apply treatment energy to each of the first and second areas of the target tissue.

### Claim 18 (depends on 14)

The process of claim 14, wherein the treatment energy raises the target tissue to up to eleven degrees Celsius at least during application of the pulsed treatment energy thereto.

### Claim 19 (depends on 14)

The process of claim 14, wherein the average target tissue temperature is maintained at six degrees Celsius or less over several minutes.

### Claim 20 (depends on 19)

The process of claim 19, wherein the average target tissue temperature is maintained at one degree Celsius or less over several minutes.

### Claim 21 (depends on 14)

The process of claim 14, wherein the applying step comprises the step of stimulating heat shock protein activation in the target tissue.

### Claim 22 (depends on 14)

The process of claim 14, wherein the treatment energy comprises radio frequency energy.

### Claim 23 (depends on 22)

The process of claim 22, wherein the treatment energy comprises a radio frequency between approximately three to six megahertz, a duty cycle of between approximately 2.5% and 5%.

### Claim 24 (depends on 23)

The process of claim 23, wherein the radio frequency is generated with coils having a radii between approximately 2 mm and 10 cm and between approximately 13 and 57 amp turns.

### Claim 25

A process for heat treating biological tissue, comprising the steps of:
providing a plurality of energy emitters formed into an array;
generating treatment energy from the plurality of emitters; and
applying the treatment energy to target tissue;
wherein the treatment energy has energy and application parameters selected so as to raise the target tissue temperature sufficiently to create a therapeutic effect while maintaining an average temperature of the target tissue over several minutes at or below a predetermined temperature so as to not destroy or permanently damage the target tissue;
wherein during an interval of time, comprising less than one second, between applications of energy applied to a first area of the target tissue, applying treatment energy to a second area of the target tissue sufficiently spaced apart from the first area of the target tissue to avoid thermal tissue damage of the target tissue; and
wherein the treatment energy comprises a radio frequency between approximately three to six megahertz, a duty cycle of between approximately 2.5% and 5%.

### Claim 26 (depends on 25)

The process of claim 25, wherein the radio frequency is generated with coils having a radii between approximately 2 mm and 10 cm and between approximately 13 and 57 amp turns.
