Method and apparatus for tissue ablation

• US 9,561,067 B2
• Filed: 01/17/2014
• Issued: 02/07/2017
• Est. Priority Date: 10/06/2008
• Status: Active Grant

• Current Assignee: Santa Anna Tech LLC
• Original Assignee: Santa Anna Tech LLC
• Inventors: Sharma, Virender K.
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US14/158,687
• Publication Number:
  US 20140200568A1
• Time in Patent Office: 1,117 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/048 : in gaseous form
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0204 : Acoustic sensors
• CPC Class Codes: A61B 5/03 : Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2210/1433 : Uterus
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Methods of ablating endometrial tissue are disclosed. The methods include providing an ablation device that has a catheter with a hollow shaft through which an ablative agent can travel, a first positioning element, and a second positioning element positioned on the catheter distal to the first positioning element. The second positioning element is a disc shaped wire mesh and has a diameter in a range of 0.1 mm to 10 cm.

Claims

1. A method of ablating endometrial tissue comprising the steps of:

providing an ablation device comprising;

a catheter having a hollow shaft through which an ablative agent can travel;

a first positioning element attached to said catheter;

a second positioning element attached to said catheter and positioned on said catheter distal to said first positioning element, wherein said second positioning element is a disc shaped wire mesh and has a diameter in a range of 0.1 mm to 10 cm;

at least one infusion port on said catheter for delivery of said ablative agent to said endometrial tissue; and

a controller comprising a microprocessor for controlling the delivery of said ablative agent;

inserting said catheter through a cervix and into a uterus of a patient such that said first positioning element is positioned in said cervix and said second positioning element is positioned proximate a fundus or body of said uterus;

deploying said first and second positioning elements such that said first positioning element contacts said cervix, said second positioning element contacts a portion of said uterus proximate said fundus or body, and said catheter and at least one infusion port are positioned within a uterine cavity of said patient; and

delivering said ablative agent through said at least one infusion port to ablate said endometrial tissue.

2. The method of claim 1, wherein said ablation device further comprises at least one sensor for measuring at least one dimension of said uterine cavity and said method further comprises the steps of:

operating said at least one sensor to measure said at least one dimension of said uterine cavity; and

using said at least one dimension of said uterine cavity to determine an amount of said ablative agent to deliver to said endometrial tissue.

3. The method of claim 2, wherein said at least one sensor comprises an infrared sensor, an electromagnetic sensor, an acoustic sensor, or a radiofrequency energy emitter and sensor.

4. The method of claim 1, wherein said first positioning element is cone shaped and, once deployed, positions said catheter in a center of said cervix and occludes a cervical opening.

5. The method of claim 4, wherein said first positioning element is covered by an insulated membrane for preventing an escape of said ablative agent through said cervix and beyond said uterine cavity.

6. The method of claim 5, wherein a segment of said catheter includes a predetermined length and said method includes the steps of:

using said predetermined length and/or the diameter of said second positioning element to estimate a size of said uterine cavity; and

using said estimated size of said uterine cavity to calculate an amount of thermal energy of said ablative agent required to ablate said endometrial tissue.

7. The method of claim 1, wherein said first positioning element is oval shaped, having a length in a range of 0.1 mm to 10 cm and a width in a range of 0.1 mm to 5 cm and, once deployed, positions said catheter in a center of said cervix and occludes a cervical opening.

8. The method of claim 1, wherein said first and second positioning elements are separated from endometrial tissue to be ablated by a distance of greater than 1 mm.

9. The method of claim 1, wherein said first and second positioning elements are positioned within an area including endometrial tissue to be ablated.

10. The method of claim 1, wherein said delivering of said ablative agent is guided by predetermined programmatic instructions.

11. The method of claim 1, wherein said ablation device further comprises at least one sensor for measuring a parameter of said uterus and said method further comprises the steps of:

operating said at least one sensor to measure said parameter of said uterus; and

using said parameter to increase or decrease a flow of said ablative agent to said endometrial tissue.

12. The method of claim 11, wherein said at least one sensor is any one of a temperature, pressure, photo, or chemical sensor.

13. The method of claim 1, wherein said ablation device further comprises a coaxial member configured to restrain said first and second positioning elements and said step of deploying said first and second positioning elements further comprises withdrawing said coaxial member over said ablation device.

14. The method of claim 1, wherein said ablation device further comprises an input device and said method further comprises using said input device to control the delivery of said ablative agent.

15. The method of claim 1, wherein said ablation device further comprises at least one input port on said catheter for receiving said ablative agent.

16. A method of ablating endometrial tissue comprising the steps of:

providing an ablation device comprising;

a catheter having a hollow shaft through which an ablative agent can travel;

a first positioning element attached to said catheter;

a second positioning element attached to said catheter and positioned on said catheter distal to said first positioning element, wherein said second positioning element is a disc shaped wire mesh and has a diameter in a range of 0.1 mm to 10 cm;

at least one infusion port on said catheter for delivery of said ablative agent to said endometrial tissue;

at least one mechanism for measuring at least one dimension of a uterine cavity; and

a controller comprising a microprocessor for controlling the delivery of said ablative agent;

inserting said catheter through a cervix and into a uterus of a patient such that said first positioning element is positioned in said cervix and said second positioning element is positioned in the uterine cavity;

deploying said first and second positioning elements such that said first positioning element contacts said cervix, said second positioning element contacts a portion of said uterus within said uterine cavity, and said catheter and at least one infusion port are positioned within said uterine cavity of said patient;

operating said at least one mechanism to measure the at least one dimension of said uterine cavity;

using said at least one dimension to determine an amount of ablative agent to deliver to said endometrial tissue; and

delivering said ablative agent through said at least one infusion port to ablate said endometrial tissue.