SYSTEMS AND METHODS FOR ASSESSING AND TREATING TISSUE

• US 20150265334A1
• Filed: 03/16/2015
• Published: 09/24/2015
• Est. Priority Date: 03/19/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: CLARK, Bryan Allen, FLANAGAN, Aiden, FRANKE, Manfred, HINCAPIE ORDONEZ, Juan, HAMANN, Jason J., SHUROS, Allan
• Granted Patent: US 9,974,597 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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
• 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 2018/00904 : Automatic detection of target tissue
• 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:

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 having 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.

2. The medical device of claim 1, wherein the distal member is an expandable distal member.

3. The medical device of claim 2, wherein the plurality of contact elements are positioned radially and axially along the expandable distal member.

4. The medical device of claim 3, wherein 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 and each of the columns include contact elements that are radially spaced about the longitudinal axis at a same axial position.

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

6. 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.

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

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

9. The medical device of claim 1, wherein the device is coupled to a control unit and each of the contact of elements are configured to be independently controlled by the control unit.

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

11. A system for delivering energy to tissue comprising:

a user interface configured to display nerve stimulation response information and treatment information, and transmit user control instructions;

a control unit having a processer configured to receive the user control instructions and control energy output;

an energy source coupled to the control unit; and

a medical device comprising;

an elongate member having a proximal end electrically coupled to the energy source; and

a distal member at a distal end of the elongate member, the distal member having a plurality of contact elements configured to deliver stimulating energy to tissue, detect a response from the tissue to the stimulating energy, and deliver therapeutic energy to treat the tissue based on the response from the tissue.

12. The system of claim 11, further comprising a location detection member configured to transmit location information, and wherein the user interface is configured to display the location information.

13. The system of claim 11, wherein each of the plurality of contact elements comprise one or more sensors.

14. The system of claim 11, wherein the control unit is configured to control different modes of the system for delivering stimulating energy and delivering therapeutic energy.

15. The system of claim 14, wherein the control unit is configured to change modes over time.

16. A method of treating innervated lung 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 the contact elements to innervated tissue proximate the target location;

detecting responses from the innervated tissue to 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; and

delivering therapeutic energy to the one or more portions of innervated tissue identified for therapy.

17. The method of claim 16, wherein during the step of delivering therapeutic energy, only the contact elements directed towards the one or more portions of innervated tissue determined for therapy deliver the therapeutic energy.

18. The method of claim 16, wherein the step of determining comprises calculating energy profiles of the innervated tissue and comparing the energy profiles to identify the one or more of the portions of the innervated tissue having a minimum nerve activation threshold.

19. The method of claim 16, wherein the therapeutic energy is sufficient to treat the one or more portions of innervated tissue determined for therapy.

20. The method of claim 16, further comprising a step of delivering stimulating energy to the one or more portions of innervated tissue to which the therapeutic energy was delivered after the step of delivering therapeutic energy.