# US 11,998,756 B2 · Apparatus and methods for determining a property of a tissue

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- Number: US 11,998,756 B2
- Document ID: US11998756B2
- Status: Granted
- Kind: B2
- Application number: 15/619,154
- Filed: 2017-06-09
- Published: 2017-09-28
- Granted: 2024-06-04
- Earliest claimed: 2007-09-28
- Assignees: Clinical Laserthermia Systems AB
- Applicants: Clinical Laserthermia Systems AB
- Inventors: Pär H. Henriksson; Karl-Göran Tranberg
- Web page: https://patentgrep.com/patent/US11998756B2

## CPC

- A61N 5/0601: {Apparatus for use inside the body}
- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00084: {Temperature}
- A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter}
- A61B 2018/208: {with multiple treatment beams not sharing a common path, e.g. non-axial or parallel}
- 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)

## Abstract

An apparatus for determining a thermal property of tissue includes a base unit with one or more energy source and at least two, preferably detachable, leads. The distal end of each lead, which is introduced into the tissue to be treated, has at least two longitudinally spaced temperature measuring elements to measure surrounding tissue temperature and at least two longitudinally spaced electrode surfaces for applying current to the tissue. Each distal end is also provided with an element which uses energy emitted by the sources of energy to heat up the surrounding tissue. The base unit has computing elements, current generating elements for generating an alternating current, and conductance determining elements for determining the tissue conductance between pairs of electrode surfaces based on the alternating current applied by the current generating elements to the tissue. Methods for using the device and leads for use in the device are also described.

## Claims

### Claim 1

A method for heat treatment of a tissue, said method comprising:
positioning a first lead above the tissue and inserting the first lead through the skin of a subject and into the tumor interstitially, such that a distal end of the first lead is positioned within the tumor; the first lead comprises a movable outer sleeve and a first tissue heating element arranged in a lumen of said movable outer sleeve and wherein said first tissue heating element comprises an optical fiber used for providing light from a bare fibre tip or a diffusor;
positioning said bare fiber tip or diffusor at a distance of between 0 and 40 mm, from an extremity of said distal end of said first lead with use of said movable sleeve and then locking said movable sleeve in place;
measuring a first temperature at or near a boundary of the tumor, wherein said first temperature is measured closer to the boundary than the bare fibre tip or diffusor;
providing energy to the first tissue heating element to heat the tumor;
monitoring a first temperature at or near the boundary of the tumor;
controlling the energy provided to the first tissue heating element in response to the monitored first temperature to heat the tissue to be treated and thereby maintain the monitored first temperature at a predefined temperature range, wherein the monitored first temperature is controlled to kill tumor cells and avoid the destruction of tumor antigens.

### Claim 2 (depends on 1)

The method of claim 1, wherein said predefined temperature range is between 42.5° C. and 48° C.

### Claim 3 (depends on 1)

The method of claim 1, wherein said heat treatment is configured for providing tumor antigens for inducing an immune response to a tumor in a mammal.

### Claim 4 (depends on 1)

The method of claim 1, wherein tissue in the tumor is heated to a temperature of between 43° C. and 46° C.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method is automated and said providing energy, monitoring, and controlling is performed by a control system comprising a microprocessor coupled to the first lead.

### Claim 6 (depends on 1)

The method of claim 1, and further comprising imaging the tumor before and/or during the insertion of the first lead into the tumor.

### Claim 7 (depends on 6)

The method of claim 6, wherein said imaging provides information about one or more of: tumor size, tumor location, location of a blood vessel in the tumor, and location of a duct in the tumor.

### Claim 8 (depends on 1)

The method of claim 1, comprising determining a depth of a light energy emission area of said first tissue heating element when said first lead is being positioned, by providing a scale of said first tissue heating element and a reference point on said sleeve.

### Claim 9 (depends on 8)

The method of claim 8, comprising locking said first tissue heating element and said sleeve in position by a locking means arranged at said sleeve.

### Claim 10

A method for heat treatment of a tissue, said method comprising:
inserting a first lead comprising a first tissue heating element into the tumor such that a distal end of the first lead is positioned within the tumor; said first tissue heating element is arranged in a lumen of a movable outer sleeve and wherein said first tissue heating element comprises an optical fiber positioned inside said first lead used for providing light through an optical fiber to a light energy emission area arranged at a distal end of said first lead, and wherein said light energy emission area is a bare fibre tip or a diffusor;
positioning said bare fiber tip or diffusor at a distance of between 0 and 40 mm, from an extremity of said distal end of said first lead with use of said movable sleeve and then locking said movable sleeve in place;
positioning a second lead comprising a first temperature sensor so that said first temperature sensor is positioned at or near a boundary of the tumor, said second lead being free from direct physical attachment to said first lead so that they are percutaneously introduced at two different locations;
providing energy to the first tissue heating element to heat to the tumor;
monitoring a first temperature at or near the boundary of the tumor by means of the first temperature sensor;
controlling the energy provided to the first tissue heating element in response to the monitored first temperature to maintain the monitored first temperature; and
controlling the energy provided to the first tissue heating element to heat tissue in the tumor and thereby kill tumor cells and avoid the destruction of tumor antigens.

### Claim 11 (depends on 10)

The method of claim 10, wherein the first lead comprises a plurality of longitudinally separated temperature sensors and controlling the energy provided to the first tissue heating element comprises controlling the energy provided in response to temperatures measured by the plurality of longitudinally separated temperature sensors.

### Claim 12 (depends on 10)

The method of claim 10, wherein the second lead comprises a plurality of longitudinally separated temperature sensors and controlling the energy provided to the first tissue heating element comprises controlling the energy provided in response to temperatures measured by the plurality of longitudinally separated temperature sensors.
