Method and apparatus for the ablation of gastrointestinal tissue

• US 9,700,365 B2
• Filed: 10/06/2009
• Issued: 07/11/2017
• 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:
  US12/573,946
• Publication Number:
  US 20100114083A1
• Time in Patent Office: 2,835 Days
• Field of Search: 606 27, 606 31, 606 45- 46, 604509, 604 9401, 60410101, 60410103, 60410105, 60410314
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/048 in gaseous form
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The present invention is directed toward a device that performs ablation of tissue. The device has a catheter with a shaft through which an ablative agent can travel, a first positioning element attached to the catheter shaft at a first position and a second positioning element attached to the catheter shaft at a second position. The shaft also has ports through which the ablative agent can be released.

Claims

1. A device adapted to treat Barrett'"'"'s esophagus in an esophagus of a patient by ablating esophageal tissue, comprising:

a catheter having an outer sheath and an inner shaft through which an ablative agent can travel, wherein the outer sheath is positioned around the inner shaft and movable with respect to the inner shaft;

a first positioning element attached to said inner shaft at a distal end of said inner shaft, wherein said first positioning element comprises an inflatable balloon configured to be positioned in a gastric cardia of the patient, thereby positioning the catheter at a fixed distance from the esophageal tissue to be ablated;

an input port at a second position and in fluid communication with said inner shaft in order to receive said ablative agent wherein the inner shaft comprises one or more ports through which said ablative agent can be released out of said inner shaft, wherein each of said one or more ports is positioned between the input port and the distal end along and circumferentially around said inner shaft and separated from the inflatable balloon by a distance of at least 1 mm; and

a controller programmed to determine an amount of thermal energy needed to ablate said esophageal tissue programmed to limit a maximum dose of said ablative agent based on a type of disorder being treated, wherein said type of disorder comprises Barrett'"'"'s esophagus, and programmed to limit the amount of thermal energy delivered such that a pressure within the patient'"'"'s esophagus does not exceed 5 atm.

2. The device of claim 1 wherein said device is configured to generate said pressure within the patient'"'"'s esophagus and wherein said pressure within the patient'"'"'s esophagus is equal to or less than 5 atm.

3. The device of claim 1 wherein the ablative agent has a temperature between 100 degrees Celsius and 200 degrees Celsius.

4. The device of claim 1 wherein said catheter further comprises a temperature sensor.

5. The device of claim 1 wherein said catheter further comprises a pressure sensor.

6. The device of claim 1 wherein a diameter of the first positioning element is between 0.01 mm and 100 mm.

7. The device of claim 1 wherein said first positioning element comprises a circular body with a diameter between 0.01 mm and 10 cm.

9. The device of claim 7 further comprising a temperature sensor wherein said temperature sensor is used to control a release of said steam.

10. The device of claim 7 wherein said first positioning element is separated from each of said plurality of ports by a distance of up to 10 cm.

11. The device of claim 7 wherein a diameter of the first positioning element is between 10 mm and 100 mm.

8. A device adapted to treat Barrett'"'"'s esophagus in an esophagus of a patient by ablating esophageal tissue, comprising

a catheter having a hollow inner shaft through which steam can be transported;

a first positioning element attached to said catheter at a distal end of said catheter, wherein said first positioning element comprises an inflatable balloon configured to abut a gastroesophageal junction when placed in a gastric cardia;

an input port at a second position and in fluid communication with said hollow inner shaft in order to receive said steam wherein the hollow inner shaft comprises a plurality of ports through which said steam can be released out of said hollow inner shaft, wherein each of said plurality of ports is positioned between the input port and the distal end along and circumferentially around said hollow inner shaft and separated from the inflatable balloon by a distance of at least 1 mm; and

a controller programmed to determine an amount of thermal energy needed to ablate said esophageal tissue, programmed to limit a maximum dose of said steam based on a type of disorder being treated, wherein said type of disorder comprises Barrett'"'"'s esophagus, and programmed to limit the amount of thermal energy delivered such that a pressure within the patient'"'"'s esophagus does not exceed 5 atm.

12. A device adapted to treat Barrett'"'"'s esophagus in an esophagus of a patient by ablating esophageal tissue, comprising

a catheter having a hollow shaft through which steam can be transported;

a first positioning element attached to said catheter at a distal end of said shaft, wherein said first positioning element comprises an inflatable balloon configured to abut the esophageal tissue;

an input port at a second position and in fluid communication with said hollow shaft in order to receive said steam wherein the hollow shaft comprises one or more ports, through which said steam can be released out of said hollow shaft onto the esophageal tissue, wherein each of said one or more ports is positioned between the input port and the distal end along and circumferentially around said shaft and separated from the inflatable balloon by a distance of at least 1 mm; and

a controller programmed to

calculate an amount of thermal energy needed to ablate said esophageal tissue based, at least in part, on a volume of said first positioning element indicative of a distance to said esophageal tissue;

limit a maximum dose of said steam based on a type of disorder being treated, wherein said type of disorder comprises Barrett'"'"'s esophagus;

determine a dimension of said esophageal tissue by using a pressure volume cycle to raise a pressure of the inflatable balloon to a predetermined level and thereby determine said volume of said first positioning element; and

limit the amount of thermal energy delivered such that a pressure within the patient'"'"'s esophagus does not exceed 5 atm.

13. The device of claim 12 further comprising a temperature sensor wherein said temperature sensor is used to control a release of said steam.

14. The device of claim 12 wherein a diameter of the first positioning element is 0.1 mm to 50 mm.