Systems and methods for assessing and treating tissue

• US 9,974,597 B2
• Filed: 03/16/2015
• Issued: 05/22/2018
• Est. Priority Date: 03/19/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Franke, Manfred, Clark, Bryan Allen, Flanagan, Aiden, Hincapie Ordonez, Juan, Hamann, Jason J., Shuros, Allan
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/658,676
• Publication Number:
  US 20150265334A1
• Time in Patent Office: 1,163 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00128 related to intensity or progress of surgical action
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2034/2061 : using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2562/0261 : Strain gauges
• CPC Class Codes: A61B 2562/0266 : Optical strain gauges
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0031 : Implanted circuitry
• CPC Class Codes: A61B 5/0036 : including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence

Abstract

A medical device including an elongate member having a proximal end configured to be electrically coupled to an energy source, and a distal member disposed at a distal end of the elongate member. The distal member may include a plurality of contact elements configured to deliver stimulating energy to innervated tissue, detect a response from the innervated tissue to the stimulating energy, and deliver therapeutic energy to the innervated tissue based on the response from the innervated tissue.

Claims

1. A medical device, comprising:

a first member having a proximal end configured to be electrically coupled to an energy source; and

a distal member disposed at a distal end of the first member, the distal member having a plurality of contact elements configured to deliver stimulating energy to tissue, detect electromyography (EMG) responses from the tissue to the stimulating energy, and deliver therapeutic energy to the tissue from only some of the plurality of contact elements based on the detected EMG responses from the tissue; and

a controller coupled to the distal member, the controller being configured to;

initiate delivery of stimulating energy from one or more of the contact elements to tissue proximate a target location;

receive electromyography (EMG) responses, from the distal member, of the tissue to the stimulating energy from one or more contact elements that are offset from the one or more of the contact elements used to deliver the stimulating energy;

determine one or more portions of the tissue for therapy based on the responses detected from the tissue to the stimulating energy;

initiate delivery of therapeutic energy from one or more of the contact elements to the one or more portions of tissue identified for therapy; and

initiate delivery of additional stimulating energy to a first location proximal to, and a second location distal to, the one or more portions of tissue to which the therapeutic energy was delivered after delivering the therapeutic energy, and initiate delivery of additional therapeutic energy to the one or more portions when stimulation at both the first location and the second location causes an EMG response greater than a threshold value.

2. The medical device of claim 1, wherein the distal member is an expandable distal member, the plurality of contact elements are positioned along the expandable distal member, and the plurality of contact elements are arranged in a plurality of rows radially spaced about a longitudinal axis of the expandable distal member, each of the plurality of rows including contact elements that are longitudinally aligned in columns.

3. The medical device of claim 1, wherein the contact elements comprise portions configured to penetrate the tissue.

4. The medical device of claim 1, wherein each of the plurality of contact elements is separated by a non-energy delivering portion of the distal member.

5. The medical device of claim 1, further comprising a location detection member configured to transmit location information.

6. The medical device of claim 1, wherein the plurality of contact elements are electrodes, and the therapeutic energy is ablative energy.

7. The medical device of claim 1, wherein distal member has a basket, balloon, spiral, or loop shape.

8. A method of treating tissue comprising:

positioning a medical device at a target location, the medical device having an expandable element and an array of contact elements;

delivering stimulating energy from one or more of the contact elements to tissue proximate the target location;

detecting electromyography (EMG) responses from the tissue to the stimulating energy from one or more contact elements that are offset from the one or more of the contact elements used to deliver the stimulating energy;

determining one or more portions of the tissue for therapy based on the responses detected from the tissue to the stimulating energy;

delivering therapeutic energy to the one or more portions of tissue identified for therapy; and

delivering additional stimulating energy to a first location proximal to, and a second location distal to, the one or more portions of tissue to which the therapeutic energy was delivered after the step of delivering therapeutic energy, and applying additional therapeutic energy to the one or more portions when stimulation at both the first location and the second location causes an EMG response greater than a threshold value.

9. The method of claim 8, wherein only some of the contact elements are used to deliver therapeutic energy during the step of delivering therapeutic energy.

10. The method of claim 8, wherein the step of determining comprises calculating energy profiles of the tissue and comparing the energy profiles to identify the one or more of the portions of the tissue having a minimum activation threshold.

11. The method of claim 8, wherein the therapeutic energy is sufficient to treat the one or more portions of tissue determined for therapy.

12. The method of claim 8, wherein additional therapeutic energy is not delivered to the one or more portions of tissue when the additional stimulation at the first location causes an EMG response below the threshold value.

13. The method of claim 8, wherein the array of contact elements includes a first row of contact elements, and a second row of contact elements circumferentially spaced apart from the first row of contact elements, and delivering stimulating energy from one or more of the contact elements to tissue proximate the target location includes:

delivering stimulating energy with only the first row of contact elements; and

after delivering the stimulating energy with only the first row of contact elements, delivering stimulating energy with only the second row of contact elements.

14. The method of claim 13, wherein detecting electromyography (EMG) responses from the tissue to the stimulating energy includes:

detecting EMG responses with the second row of contact elements when the stimulation energy is delivered with only the first row of contact elements;

after the delivery of stimulation energy with only the first row of contact elements, detecting EMG responses from the tissue with the first row of contact elements in response to the stimulation from only the first row of contact elements;

detecting EMG responses with the first row of contact elements when the stimulation energy is delivered with only the second row of contact elements; and

after the delivery of stimulation energy with only the second row of contact elements, detecting electromyography responses from the tissue with the second row of contact elements in response to the stimulation from only the second row of contact elements.

15. The method of claim 8, wherein the tissue is innervated tissue, and the method further includes detecting electroneurography (ENG) responses from the innervated tissue to the stimulating energy from one or more contact elements that are offset from the one or more of the contact elements used to deliver the stimulating energy.

16. The method of claim 8, wherein the one or more portions of tissue where therapeutic energy is delivered is in a first generation bronchus or a second generation bronchus.

17. A method of treating lung tissue comprising:

positioning a medical device at a target location within a first generation bronchus or a second generation bronchus of the lung, the medical device having an expandable element and an array of contact elements;

delivering stimulating energy from one or more of the contact elements to innervated tissue proximate the target location;

detecting electromyography (EMG) and electroneurography (ENG) responses from the innervated tissue to the stimulating energy from one or more contact elements that are circumferentially offset from the one or more of the contact elements used to deliver the stimulating energy;

determining one or more portions of the innervated tissue for therapy based on the responses detected from the innervated tissue to the stimulating energy;

delivering therapeutic energy to the one or more portions of innervated tissue identified for therapy from only some of the contact elements;

delivering additional stimulating energy to a first location proximal to, and a second location distal to, the one or more portions of innervated tissue to which the therapeutic energy was delivered, after the step of delivering therapeutic energy; and

applying additional therapeutic energy to the one or more portions when stimulation at both the first location and the second location causes an EMG or ENG response greater than a respective threshold value, wherein additional therapeutic energy is not delivered to the one or more portions of tissue when the additional stimulation at the first location causes an EMG or ENG response below the respective threshold value.

18. The method of claim 17, wherein the array of contact elements includes a first row of contact elements, and a second row of contact elements circumferentially spaced apart from the first row of contact elements, and delivering stimulating energy from one or more of the contact elements to tissue proximate the target location includes:

delivering stimulating energy with only the first row of contact elements; and

after delivering the stimulating energy with only the first row of contact elements, delivering stimulating energy with only the second row of contact elements; and

wherein detecting EMG and ENG responses from the innervated tissue to the stimulating energy from one or more contact elements includes;

detecting EMG and ENG responses with the second row of contact elements when the stimulation energy is delivered with only the first row of contact elements;

after the delivery of stimulation energy with only the first row of contact elements, detecting EMG and ENG responses from the tissue with the first row of contact elements in response to the stimulation from only the first row of contact elements;

detecting EMG and ENG responses with the first row of contact elements when the stimulation energy is delivered with only the second row of contact elements; and

after the delivery of stimulation energy with only the second row of contact elements, detecting EMG and ENG responses from the tissue with the second row of contact elements in response to the stimulation from only the second row of contact elements.