# US 8,465,534 B2 · Radio-frequency tissue welder with polymer reinforcement

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- Number: US 8,465,534 B2
- Document ID: US8465534B2
- Status: Granted
- Kind: B2
- Application number: 13/102,947
- Filed: 2011-05-06
- Published: 2011-09-01
- Granted: 2013-06-18
- Earliest claimed: 2008-05-20
- Applicants: David A. Schechter
- Inventors: David A. Schechter
- Web page: https://patentgrep.com/patent/US8465534B2

## CPC

- A61B 18/1445: {at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod}
- A61B 10/02: Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61B 18/20: using laser
- A61B 2017/00805: {Treatment of female stress urinary incontinence}
- A61B 2018/00011: {with fluids}
- A61B 2018/00065: {porous}
- A61B 2018/00095: {high, i.e. heat conducting}
- A61B 2018/0013: {non-sticking}
- A61B 2018/00619: {Welding}
- A61B 2018/0063: {Sealing}
- A61B 2018/1412: {Blade}
- A61B 2018/1455: {having a moving blade for cutting tissue grasped by the jaws}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61N 7/02: Localised ultrasound hyperthermia
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

There are disclosed methods and apparatus for attachment and welding of tissue. In an embodiment, the apparatus includes an energy applicator configured to apply energy to generate heat within a target tissue to evaporate water to create dried tissue, and a thermally conductive material disposed adjacent the first tissue contacting surface or the second tissue contacting surface. The thermally conductive material may be configured for direct contact with the target tissue heated by the energy applicator. The thermally conductive material provides a high coefficient of thermal conductivity so as to evenly distribute heat within the targeted tissue area. Other embodiments are also disclosed.

## Claims

### Claim 1

Apparatus for attachment and welding of tissue, the apparatus comprising:
an energy applicator positioned adjacent a first tissue contacting surface, the energy applicator configured to apply an amount of energy to generate heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue, and denature at least one of collagen and elastin within the target tissue to attach portions of the target tissue together; and
a thermally conductive material disposed at a second tissue contacting surface, the thermally conductive material configured for direct contact with the target tissue heated by the energy applicator, and the thermally conductive material providing a path of thermal conduction.

### Claim 2 (depends on 1)

Apparatus in accordance with claim 1, wherein the thermally conductive material is a thermally conductive polymer.

### Claim 3 (depends on 1)

Apparatus in accordance with claim 1, wherein the thermally conductive material is a biopolymer applicator.

### Claim 4 (depends on 1)

Apparatus in accordance with claim 1, wherein the thermally conductive material is a porous plate.

### Claim 5 (depends on 1)

Apparatus in accordance with claim 1, wherein the at least one of the first tissue contacting surface and the second tissue contacting surface include electrode materials and end-effector materials, and wherein the electrode materials and end-effector materials have a high coefficient of thermal conductivity so as to evenly distribute heat within the targeted tissue area.

### Claim 6 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials are electrically insulative.

### Claim 7 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials have coefficients of thermal conductivity greater than approximately 10 W/mK.

### Claim 8 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials have electrical resistivity in the range of 1012 to 1016 ohm-cm.

### Claim 9 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials resist surface breakdown and tracking as measured by a Comparative Tracking Index (ASTM D3638) at voltages greater than 300V.

### Claim 10 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials in contact with the target tissue have a low thermal mass and specific heat capacity less than approximately 1.30 J/g° C., so as not to divert energy required for tissue fusion back into the energy applicator.

### Claim 11 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials in contact with the target tissue are thermally insulated from other portions of the energy applicator so as not to divert energy required for tissue fusion back into the energy applicator.

### Claim 12 (depends on 5)

Apparatus in accordance with claim 5, wherein at least one of the electrode materials and end-effector materials comprise a thermally conductive material including at least one of polyimide (PI), polyamide-imine (PAI), polyphthalamide (PPA), polyphenylene sulfide (PPS), liquid crystalline polymer (LCP), and silicone.

### Claim 13 (depends on 12)

Apparatus in accordance with claim 12, wherein the thermally conductive material has been formulated with a thermally conductive filler.

### Claim 14 (depends on 12)

Apparatus in accordance with claim 12, wherein the thermally conductive material comprises boron nitride.

### Claim 15 (depends on 5)

Apparatus in accordance with claim 5, wherein the energy applicator includes a set of jaws.

### Claim 16 (depends on 5)

Apparatus in accordance with claim 5, further comprising a pressure controller in operable connection with the set of jaws, wherein the pressure controller has a low pressure setting and a high pressure setting, wherein the low pressure setting is configured to allow the jaws to apply a low amount of pressure so as to grasp and approximate tissue without excessive damage to the tissue, and wherein the high pressure setting is configured to allow the jaws to apply a high amount of pressure so as to clamp the tissue for welding with the energy applicator and the thermally conductive material disposed at the at least one of the first tissue contacting surface and the second tissue contacting surface.

### Claim 17 (depends on 5)

Apparatus in accordance with claim 5, further comprising a pressure controller in operable connection with a set of jaws, wherein the pressure controller is configured to allow the jaws to apply a pressure is between 5 to 10 kgf/cm2 and the pressure is distributed over substantially an entire portion of the tissue contacting surface.

### Claim 18

Apparatus for attachment and welding of tissue, the apparatus comprising:
an energy applicator positioned adjacent at least one of a first tissue contacting surface and a second tissue contacting surface, the energy applicator configured to apply an amount of energy to generate heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue, and denature at least one of collagen and elastin within the target tissue to attach portions of the target tissue together; and
a thermally conductive material disposed adjacent the at least one of the first tissue contacting surface and the second tissue contacting surface, the thermally conductive material configured for direct contact with the target tissue heated by the energy applicator, and the thermally conductive material providing a high coefficient of thermal conductivity so as to evenly distribute heat within the targeted tissue area.

### Claim 19 (depends on 18)

Apparatus in accordance with claim 18, wherein the energy applicator comprises electrodes offset by a distance, the electrodes configured to direct current flow through the compressed tissue in an direction coplanar to the at least one of the first tissue contacting surface and the second tissue contacting surface, and wherein the applied voltage does not exceed about 100 V(rms)/mm with respect to the offset electrode spacing between the electrodes.

### Claim 20 (depends on 18)

Apparatus in accordance with claim 18, wherein the at least one of the first tissue contacting surface and the second tissue contacting surface comprises of a non-stick material.

### Claim 21 (depends on 18)

Apparatus in accordance with claim 18, wherein the energy applicator comprises a knife for division of the target tissue.

### Claim 22 (depends on 21)

Apparatus in accordance with claim 21, wherein the knife is attached to a deployable electrode portion of a radio-frequency applicator of the energy applicator.

### Claim 23 (depends on 21)

Apparatus in accordance with claim 21, wherein the knife is configured to separate the target tissue during or after RF activation.

### Claim 24 (depends on 18)

Apparatus in accordance with claim 18, wherein the non-stick material is PTFE.

### Claim 25

Apparatus for attachment and welding of tissue, the apparatus comprising:
an energy applicator positioned adjacent at least one of a first tissue contacting surface and a second tissue contacting surface, the energy applicator configured to apply an amount of energy to generate heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue, and denature at least one of collagen and elastin within the target tissue to attach portions of the target tissue together; and
electrodes of the energy applicator offset by a distance, the electrodes configured to direct current flow through the compressed tissue in an direction coplanar to the at least one of the first tissue contacting surface and the second tissue contacting surface, and an applied voltage of the energy applicator not exceeding about 100 V(rms)/mm with respect to the offset electrode spacing between the electrodes.

### Claim 26 (depends on 25)

Apparatus in accordance with claim 25, wherein the energy applicator includes a set of jaws.

### Claim 27 (depends on 25)

Apparatus in accordance with claim 25, further comprising a pressure controller in operable connection with the set of jaws, wherein the pressure controller has a low pressure setting and a high pressure setting, wherein the low pressure setting is configured to allow the jaws to apply a low amount of pressure so as to grasp and approximate tissue without excessive damage to the tissue, and wherein the high pressure setting is configured to allow the jaws to apply a high amount of pressure so as to clamp the tissue for welding with the energy applicator and the thermally conductive material disposed at the at least one of the first tissue contacting surface and the second tissue contacting surface.

### Claim 28 (depends on 25)

Apparatus in accordance with claim 25, wherein the pressure controller is configured to allow the jaws to apply a pressure is between 5 to 10 kgf/cm2 and the pressure is distributed over substantially an entire portion of the at least one of the first tissue contacting surface and the second tissue contacting surface.

### Claim 29 (depends on 25)

Apparatus in accordance with claim 25, wherein the energy applicator comprises a knife for division of the target tissue.

### Claim 30 (depends on 29)

Apparatus in accordance with claim 29, wherein the knife is attached to a deployable electrode portion of a radio-frequency applicator of the energy applicator.

### Claim 31 (depends on 29)

Apparatus in accordance with claim 29, wherein the knife is configured to separate the target tissue during or after RF activation.

### Claim 32

A method of attaching and reinforcing tissue, the method comprising:
applying energy adjacent to tissue surfaces with an energy applicator, wherein the application of the energy is configured to generate an amount of heat within a target tissue so as to evaporate intracellular and extracellular water from a target tissue to create dried tissue; and
directing contact with the target tissue heated by the energy applicator with a thermally conductive material disposed adjacent the at least one of the first tissue contacting surface and the second tissue contacting surface, and evenly distributing heat within the targeted tissue area with the thermally conductive material providing a high coefficient of thermal conductivity.

### Claim 33

A method of reinforcing tissue, the method comprising:
applying energy adjacent a tissue surface with an energy applicator, wherein the application of the energy is configured to generate an amount of heat within a target tissue so as to evaporate intracellular and extracellular water from the target tissue to create dried tissue; and
directing current flow through the compressed tissue in an direction coplanar to the at least one of the first tissue contacting surface and the second tissue contacting surface with electrodes of the energy applicator offset by a distance, and limiting an applied voltage of the energy applicator to not exceed about 100 V(rms)/mm with respect to the offset electrode spacing between the electrodes.
