# US 2026/0061143 A1 · Maintaining thermal energy tissue shrinkage and restoring mechanical properties of the tissue via protein crosslinker delivery

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- Number: US 2026/0061143 A1
- Document ID: US20260061143A1
- Status: Published application
- Kind: A1
- Application number: 19/311,979
- Filed: 2025-08-27
- Published: 2026-03-05
- Earliest claimed: 2024-08-28
- Assignees: Spinal Simplicity, LLC
- Applicants: Spinal Simplicity, LLC
- Inventors: Thomas P. Hedman; Adam Rogers; John Goebel
- Web page: https://patentgrep.com/patent/US20260061143A1

## CPC

- A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/1477: {Needle-like probes}
- A61B 18/16: Indifferent or passive electrodes for grounding
- A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)}
- A61M 5/46: having means for controlling depth of insertion
- A61B 2018/00714: {Temperature}
- A61B 2018/00791: {Temperature}
- A61B 2018/0293: {using an instrument interstitially inserted into the body, e.g. needle}
- A61B 2018/126: {bipolar}
- A61B 2018/1425: {Needle}
- A61B 2018/143: {multiple needles}
- A61B 2018/162: {located on the probe body}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method, kits, and devices for performing the method of immediately improving and/or restoring the mechanical integrity and material properties of thermally shrunk collagenous tissue through delivery of a non-toxic protein crosslinker to the tissue. A thermal energy device shrinks the target tissue using controlled application of thermal energy. A non-toxic protein crosslinker is injected and/or topically applied to the target tissue before, during, and/or after thermal shrinkage. A dual applicator may comprise a thermal energy probe and injection needle. The thermal energy probe may apply thermal energy to the target tissue and the injection needle may apply the non-toxic protein crosslinker to the target tissue. A kit for use in performing the method may provide various components used for applying thermal energy and applying the non-toxic protein crosslinker to the target tissue.

## Claims

### Claim 1

A method of delivering a protein crosslinker to a target tissue at a treatment site, the method comprising:
creating a minimally invasive incision at the treatment site;
inserting a thermal energy device into the minimally invasive incision;
applying thermal energy to the target tissue using the thermal energy device,
wherein applying thermal energy further comprises contacting at least a portion of the target tissue with the thermal energy device to shrink the target tissue; and
contacting the shrunk target tissue with a protein crosslinker to thereby restore a mechanical property of the shrunk target tissue, such that a mechanical integrity of the shrunk target issue is improved.

### Claim 2 (depends on 1)

The method of claim 1,
wherein contacting at least a portion of the shrunk target tissue with the protein crosslinker comprises injecting the protein crosslinker into the shrunk target tissue.

### Claim 3 (depends on 2)

The method of claim 2,
wherein the protein crosslinker is genipin and the genipin is solubilized in a buffer to form a genipin reagent;
wherein the genipin reagent contains genipin within a range of 10 mM to 100 mM;
wherein the buffer contains 50 mM to 500 mM phosphate ions and 50 mM to 250 mM 4-(2-Hydroxyethyl)-1-piperazinepropanesulfonic acid; and
wherein the genipin reagent is buffered at a pH between 8.0 and 10.0.

### Claim 4 (depends on 1)

The method of claim 1, wherein the mechanical property is at least one of strength, fatigue resistance, stress-relaxation, creep, Young's modulus, yield stress, yield strain, ultimate tensile stress, ultimate tensile strain, resilience, toughness, load-history dependence, hysteresis, storage and loss moduli.

### Claim 5 (depends on 1)

The method of claim 1,
wherein the thermal energy device defines a proximal end, a distal end, and a hollow extending from the distal end to the proximal end,
wherein contacting the shrunk target tissue with the protein crosslinker further comprises:
injecting the protein crosslinker through the hollow.

### Claim 6 (depends on 1)

The method of claim 1, wherein contacting the shrunk target tissue with the protein crosslinker comprises placing at least one of a microneedle patch, a biodegradable film, a biodegradable gel, or a protein crosslinker-coated suture on the shrunk target tissue.

### Claim 7 (depends on 1)

The method of claim 1,
wherein the thermal energy device comprises a bipolar radiofrequency probe having at least one active electrode and at least one return electrode.

### Claim 8

A dual applicator for treating a target tissue comprising:
a housing;
a thermal energy probe received in the housing,
wherein the thermal energy probe is longitudinally translatable within the housing;
an energy supply connection interface coupled to the thermal energy probe and configured to supply thermal energy to the thermal energy probe; and
an injection needle comprised in the housing and coupled to a trigger;
wherein actuating the trigger causes longitudinal translation of the injection needle to thereby adjust a depth of the injection needle inserted into the target tissue.

### Claim 9 (depends on 8)

The dual applicator of claim 8, further comprising a Luer lock connector operable to receive a syringe vial.

### Claim 10 (depends on 8)

The dual applicator of claim 8, further comprising a depth gauge, wherein the depth gauge indicates a position of the injection needle.

### Claim 11 (depends on 8)

The dual applicator of claim 8, wherein actuating the energy supply connection interface longitudinal translates the thermal energy probe.

### Claim 12 (depends on 9)

The dual applicator of claim 9, further comprising an aperture, wherein the aperture provides a view of the syringe vial connected to the Luer lock connector.

### Claim 13 (depends on 8)

The dual applicator of claim 8, wherein the thermal energy probe is a bipolar radiofrequency probe comprising at least one active electrode and at least one return electrode.

### Claim 14 (depends on 8)

The dual applicator of claim 8, wherein the injection needle is received through a hollow in the housing.

### Claim 15

A method of treating a target tissue, comprising:
creating a minimally invasive incision,
inserting, through the minimally invasive incision, a distal end of a dual applicator, wherein the dual applicator comprises:
a thermal energy probe;
an injection needle;
a trigger; and
a vial containing a protein crosslinker;
adjusting a position of the thermal energy probe relative to the target tissue,
wherein the adjustment comprises contacting a first region of the target tissue with the thermal energy probe;
applying thermal energy to the first region via the thermal energy probe,
adjusting a position of the injection needle relative to the target tissue,
wherein the adjustment of the injection needle comprises:
inserting the injection needle into the first region; and
actuating the trigger to translate the injection needle within the dual applicator; and
delivering the protein crosslinker to the first region from the vial.

### Claim 16 (depends on 15)

The method of claim 15, further comprising:
performing a second adjustment of the position of the injection needle,
wherein the second adjustment of the position of the injection needle comprises inserting the injection needle into a second region by actuating the trigger to translate the injection needle out of the first region and into the second region; and
delivering the protein crosslinker to the second region from the vial.

### Claim 17 (depends on 15)

The method of claim 15, wherein applying thermal energy to the first region comprises applying a voltage within a range of 10 volts to 500 volts to the first region.

### Claim 18 (depends on 15)

The method of claim 15, wherein applying thermal energy to the first region comprises applying thermal energy to the first region until the first region reaches a predefined temperature.

### Claim 19 (depends on 15)

The method of claim 15, wherein applying thermal energy to the first region further comprises:
applying thermal energy to the first region of the target tissue until the target tissue has shrunk by within a range of 10% to 50% of a pre-treatment length of the target tissue.

### Claim 20 (depends on 15)

The method of claim 15, wherein the dual applicator further comprises an energy supply connection interface coupled to the thermal energy probe and configured to supply thermal energy to the thermal energy probe,
wherein adjusting the position of the thermal energy probe further comprises moving the energy supply connection interface to thereby translate the thermal energy probe.
