# US 12,109,072 B2 · Protecting non-target tissue during ablation procedures and related systems and methods

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- Number: US 12,109,072 B2
- Document ID: US12109072B2
- Status: Granted
- Kind: B2
- Application number: 17/325,858
- Filed: 2021-05-20
- Published: 2021-12-23
- Granted: 2024-10-08
- Earliest claimed: 2020-06-22
- Assignees: Medtronic Navigation, Inc.
- Applicants: Medtronic Navigation, Inc.
- Inventors: Christine Drown; Rebecca Vincelette
- Web page: https://patentgrep.com/patent/US12109072B2

## CPC

- A61B 18/22: the beam being directed along or through a flexible conduit, e.g. an optical fibre; {Couplings or} hand-pieces therefor
- A61B 90/04: {Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery (protection of eyes against laser radiation A61F9/022)}
- A61B 18/20: using laser
- A61B 2017/00128: {related to intensity or progress of surgical action}
- A61B 2018/00446: {Brain}
- A61B 2018/00452: {Skin}
- A61B 2018/00511: {Kidney}
- A61B 2018/00529: {Liver}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/0066: {without feedback, i.e. open loop control}
- A61B 2018/00666: {using a threshold value}
- A61B 2018/00678: {upper}
- A61B 2018/00708: {switching the power on or off}
- A61B 2018/00714: {Temperature}
- A61B 2018/00791: {Temperature}
- A61B 2018/00898: {Alarms or notifications created in response to an abnormal condition}
- A61B 2090/0409: {Specification of type of protection measures}
- A61B 2090/049: {against light, e.g. laser}
- A61B 2090/374: {NMR or MRI}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems and methods for protecting non-target tissue from damage during a medical procedure for disrupting target tissue via heat application are disclosed. Data associated with the target tissue to be disrupted may be received. Based on the received data, one or more non-target objects of tissue that may be affected by the applied heat are identified. Both a temperature threshold and thermal dose threshold for each of the one or more non-target objects may be generated. Both the temperature and the thermal dose of each of the one or more non-target objects may be evaluated during performance of the medical procedure. A response may be generated when either the evaluated temperature of any of the one or more non-target objects reaches the corresponding temperature threshold or the thermal dose of any of the one or more non-target objects reaches the corresponding thermal dose threshold.

## Claims

### Claim 1

A computer system comprising:
one or more processors; and
one or more non-transitory computer-readable storage media having stored thereon computer-executable instructions that are executable by the one or more processors to cause the computer system to protect non-target tissue from damage during a medical procedure for applying heat to a target tissue, the computer-executable instructions including instructions that are executable to cause the computer system to perform at least the following:
receive images of a zone of tissue comprising the non-target tissue and the target tissue;
determine, based on the images of the zone of tissue, one or more non-target objects of tissue that are both different than the target tissue and that are susceptible to damage from an amount of the heat applied to the target tissue;
identify, based on the images of the zone of tissue, a type of tissue associated with each of the one or more non-target objects of tissue;
determine, based at least partially on the type of tissue identified, a temperature threshold for each of the one or more non-target objects of tissue, wherein the temperature threshold comprises a first temperature for each of the one or more non-target objects of tissue at which a corresponding non-target object of the type of tissue identified is damaged quickly in a first amount of time;
determine, based at least partially on the type of tissue identified, a thermal dose threshold for each of the one or more non-target objects of tissue, wherein the thermal dose threshold corresponds to an accumulation of thermal energy over time at which the corresponding non-target object of the type of tissue identified begins to physiologically alter when a second temperature is applied to the corresponding non-target object of the type of tissue identified over a second amount of time, wherein the second temperature is less than the first temperature, and wherein the second amount of time is greater than the first amount of time;
determine, based on measurements received from a temperature sensor, a temperature at each of the one or more non-target objects of tissue during performance of the medical procedure;
determine, based on the temperature determined and the heat applied to the target tissue, an amount of accumulated thermal energy of each of the one or more non-target objects of tissue during performance of the medical procedure when the temperature at each of the one or more non-target objects of tissue determined to be lower than the first temperature, wherein the amount of accumulated thermal energy comprises the temperature at each of the one or more non-target objects of tissue and a duration that the temperature at each of the one or more non-target objects of tissue is applied over a period of time during performance of the medical procedure;
cause a representation of the amount of accumulated thermal energy of each of the one or more non-target objects of tissue to be rendered to a user interface of a display device during performance of the medical procedure; and
cause a response alert to be output by the computer system when the amount of accumulated thermal energy of any of the one or more non-target objects of tissue reaches the thermal dose threshold for the corresponding non-target object of the type of tissue identified.

### Claim 2 (depends on 1)

The computer system of claim 1, wherein the medical procedure comprises a laser ablation procedure.

### Claim 3 (depends on 1)

The computer system of claim 1, wherein determining the one or more non-target objects of tissue includes identifying a subtype of tissue associated with each of the one or more non-target objects of tissue identified.

### Claim 4 (depends on 1)

The computer system of claim 1, wherein the computer-executable instructions further include instructions that are executable to cause the computer system to:
cause a damage response alert to be output by the computer system when the temperature of any of the one or more non-target objects reaches the temperature threshold for the corresponding non-target object of type of tissue identified.

### Claim 5 (depends on 1)

The computer system of claim 1, wherein the type of tissue identified for at least one of the one or more non-target objects of tissue comprises brain tissue, kidney tissue, liver tissue, or skin tissue.

### Claim 6 (depends on 1)

The computer system of claim 1, wherein the computer-executable instructions further include instructions that are executable to cause the computer system to:
determine a tissue structure of at least one of the one or more non-target objects of tissue to determine a criticality associated with the at least one of the one or more non-target objects of tissue, wherein the criticality defines an importance of the at least one of the one or more non-target objects of tissue relative to other non-target objects of tissue; and
adjust, based on the criticality, an output of the heat applied to the target tissue during the medical procedure from a first energy level to a second energy level, wherein the second energy level is lower than the first energy level.

### Claim 7 (depends on 1)

The computer system of claim 1, wherein, when the amount of accumulated thermal energy of any of the one or more non-target objects of tissue reaches the thermal dose threshold for the corresponding non-target object of the type of tissue identified, the computer-executable instructions further include instructions that are executable to cause the computer system to automatically reduce an amount of heat applied to the target tissue.

### Claim 8 (depends on 1)

The computer system of claim 1, wherein the computer-executable instructions further include instructions that are executable to cause the computer system to determine the amount of accumulated thermal energy of each of the one or more non-target objects of tissue after a heat source generating the heat has stopped and restarted based at least in part on an amount of time that each of the one or more non-target objects of tissue absorbed the heat before the heat source stopped and before the heat source restarted.

### Claim 9 (depends on 1)

The computer system of claim 1, wherein the computer-executable instructions further include instructions that are executable to cause the computer system to:
receive, in real time, data associated with the target tissue during the medical procedure; and
determine, based on the data received, the one or more non-target objects of tissue.

### Claim 10 (depends on 1)

The computer system of claim 1, wherein the thermal dose threshold for each of the one or more non-target objects of tissue is associated with an accumulation of thermal energy at which the corresponding non-target object of the type of tissue identified begins to physiologically alter by necrosis.

### Claim 11 (depends on 1)

The computer system of claim 1, wherein the thermal dose threshold for each of the one or more non-target objects of tissue is associated with an accumulation of thermal energy at which the corresponding non-target object of the type of tissue identified begins to physiologically alter by opening a blood-brain barrier.

### Claim 12

A method for protecting non-target tissue from damage during a medical procedure for applying heat to a target tissue, comprising:
determining, by one or more processors based on images received of a zone of tissue, one or more non-target objects of tissue that are both different than the target tissue and that are susceptible to damage from an amount of the heat applied to the target tissue;
identifying, by the one or more processors based on the images received of the zone of tissue, a type of tissue associated with each of the one or more non-target objects of tissue;
determining, by the one or more processors, a temperature threshold for each of the one or more non-target objects of tissue, wherein the temperature threshold comprises a first temperature for each of the one or more non-target objects of tissue at which a corresponding non-target object of the type of tissue identified is damaged quickly in a first amount of time;
determining, by the one or more processors, a thermal dose threshold for each of the one or more non-target objects of tissue based at least partially on the type of tissue identified, wherein the thermal dose threshold corresponds to an accumulation of thermal energy over time at which a the corresponding non-target object of the type of tissue identified begins to physiologically alter when a second temperature is applied to the corresponding non-target object of the type of tissue identified over a second amount of time, wherein the second temperature is less than the first temperature, and wherein the second amount of time is greater than the first amount of time;
determining, by the one or more processors based on measurements received from a temperature sensor, a temperature at each of the one or more non-target objects of tissue during performance of the medical procedure;
determining, by the one or more processors based on the temperature determined and the heat applied to the target tissue, an amount of accumulated thermal energy of each of the one or more non-target objects of tissue during performance of the medical procedure when the temperature at each of the one or more non-target objects of tissue determined to be lower than the first temperature, wherein the amount of accumulated thermal energy comprises the temperature at each of the one or more non-target objects of tissue and a duration that the temperature at each of the one or more non-target objects of tissue is applied over a period of time during performance of the medical procedure;
causing, by the one or more processors, a representation of the amount of accumulated thermal energy of each of the one or more non-target objects of tissue to be rendered to a user interface of a display device during performance of the medical procedure; and
causing, by the one or more processors, a response alert to be output when the amount of accumulated thermal energy of any of the one or more non-target objects of tissue reaches the thermal dose threshold for the corresponding non-target object of the type of tissue identified.

### Claim 13 (depends on 12)

The method of claim 12, wherein the medical procedure comprises a laser ablation procedure.

### Claim 14 (depends on 12)

The method of claim 12, wherein the type of tissue identified for at least one of the one or more non-target objects of tissue comprises brain tissue, kidney tissue, liver tissue, or skin tissue.

### Claim 15 (depends on 12)

The method of claim 12, further comprising:
determining, by the one or more processors, a tissue structure of at least one of the one or more non-target objects of tissue to determine a criticality associated with the at least one of the one or more non-target objects of tissue, wherein the criticality defines an importance of the at least one of the one or more non-target objects of tissue relative to other non-target objects of tissue; and
adjusting, by the one or more processors based on the criticality, an output of the heat applied to the target tissue during the medical procedure from a first energy level to a second energy level, wherein the second energy level is lower than the first energy level.

### Claim 16 (depends on 12)

The method of claim 12, further comprising:
causing an amount of heat applied to the target tissue to be reduced when the amount of accumulated thermal energy of any of the one or more non-target objects of tissue reaches the thermal dose threshold for the corresponding non-target object of the type of tissue identified.

### Claim 17

A computer program product comprising one or more non-transitory computer readable media having stored thereon computer-executable instructions that are executable by one or more processors of a computer system to cause the computer system to protect non-target tissue from damage during a medical procedure for applying heat to a target tissue, the computer-executable instructions including instructions that are executable to cause the computer system to perform at least the following:
receive images of a zone of tissue comprising the non-target tissue and the target tissue;
determine, based on the images of the zone of tissue, one or more non-target objects of tissue that are both different than the target tissue and that are susceptible to damage from an amount of the heat applied to the target tissue;
identify, based on the images of the zone of tissue, a type of tissue associated with each of the one or more non-target objects of tissue;
determine, based at least partially on the type of tissue identified, a temperature threshold for each of the one or more non-target objects of tissue, wherein the temperature threshold comprises a first temperature for each of the one or more non-target objects of tissue at which a corresponding non-target object of the type of tissue identified is damaged quickly in a first amount of time;
determine, based at least partially on the type of tissue identified, a thermal dose threshold for each of the one or more non-target objects of tissue, wherein the thermal dose threshold corresponds to an accumulation of thermal energy over time at which the corresponding non-target object of the type of tissue identified begins to physiologically alter when a second temperature is applied to the corresponding non-target object of the type of tissue identified over a second amount of time, wherein the second temperature is less than the first temperature, and wherein the second amount of time is greater than the first amount of time;
determine, based on measurements received from a temperature sensor, a temperature at each of the one or more non-target objects of tissue during performance of the medical procedure;
determine, based on the temperature determined and the heat applied to the target tissue, an amount of accumulated thermal energy of each of the one or more non-target objects of tissue during performance of the medical procedure, wherein the amount of accumulated thermal energy comprises the temperature at each of the one or more non-target objects of tissue and a duration that the temperature at each of the one or more non-target objects of tissue is applied over a period of time during performance of the medical procedure when the temperature at each of the one or more non-target objects of tissue determined to be lower than the first temperature;
cause a representation of the amount of accumulated thermal energy of each of the one or more non-target objects of tissue to be rendered to a user interface of a display device during performance of the medical procedure; and
cause a response alert to be output when the amount of accumulated thermal energy of any of the one or more non-target objects of tissue reaches the thermal dose threshold for the corresponding non-target object of the type of tissue identified.

### Claim 18 (depends on 17)

The computer program product of claim 17, wherein the computer-executable instructions further include instructions that are executable to cause the computer system to:
cause a damage response alert to be output by the computer system when the temperature of any of the one or more non-target objects reaches the temperature threshold for the corresponding non-target object of type of tissue identified.

### Claim 19 (depends on 17)

The computer program product of claim 17, wherein the thermal dose threshold for each of the one or more non-target objects of tissue is associated with an accumulation of thermal energy at which the corresponding non-target object of the type of tissue identified begins to necrotize.

### Claim 20 (depends on 19)

The computer program product of claim 19, wherein a temperature threshold for each of the one or more non-target objects of tissue is associated with a temperature at which the corresponding non-target object of the type of tissue identified begins to open a blood-brain barrier.

### Claim 21 (depends on 12)

The method of claim 12, further comprising:
causing, by the one or more processors, a damage response alert to be output by a computer system when the temperature of any of the one or more non-target objects reaches the temperature threshold for the corresponding non-target object of type of tissue identified.
