Systems and methods for applying a selected treatment agent into contact with tissue to treat sphincter dysfunction

• US 20020115992A1
• Filed: 11/26/2001
• Published: 08/22/2002
• Est. Priority Date: 06/04/1998
• Status: Active Grant

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Curon Medical, Inc.
• Inventors: Gaiser, John W., Utley, David S., Croft, Rachel
• Granted Patent: US 6,802,841 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• 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 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/0066 : without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

Systems and methods apply a selected treatment agent or agents into contact with tissue at or in the region of a dysfunctional sphincter (in the case of GERD, fecal incontinence, or other dysfunctional sphincter disorders) to affect improved sphincter barrier function and/or to disrupt abnormal nerve pathways. The treatment agent can include at least one cytokine and/or at least one tissue bulking agent and/or at least one vanilloid compound to evoke a desired tissue response. The systems and methods can be used a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.

Claims

1. An apparatus for treating tissue at or near a sphincter comprising

an operative element adapted, in use, to be deployed adjacent to a tissue region, at, or near a sphincter,

a source of treatment agent including at least one cytokine coupled to the operative element to apply the treatment agent into contact with the tissue region.

3. An apparatus according to claim 1 or 2

wherein the operative element applies the treatment agent to surface tissue.

4. An apparatus according to claim 1 or 2

wherein the operative element injects the treatment agent into subsurface tissue.

5. An apparatus according to claim 1 or 2

wherein the operative element includes an electrode to apply energy to the tissue region to form at least one lesion.

6. An apparatus according to claim 5

wherein the operative element applies the treatment agent through a lumen in the electrode.

7. An apparatus according to claim 5

wherein the operative element applies the treatment agent through a lumen that is adjacent to the electrode.

2. An apparatus for treating tissue at or near a sphincter comprising

an operative element adapted, in use, to be deployed adjacent a tissue region at or near a sphincter,

a source of treatment agent including at least one vanilloid compound coupled to the operative element to apply the treatment agent into contact with the tissue region.

8. A method for treating a tissue region at or near a sphincter comprising the steps of

deploying an operative element adjacent a tissue region at or near a sphincter, and

applying through the operative element a treatment agent including at least one cytokine into contact with the tissue region.

10. A method according to claim 8 or 9

further including the step of forming at least one lesion in the tissue region to which the treatment agent is applied.

11. A method according to claim 8 or 9

wherein the treatment agent is applied to surface tissue.

12. A method according to claim 8 or 9

wherein the treatment agent is injected into subsurface tissue.

14. An apparatus according to claim 13

wherein the operative element injects the treatment agent into subsurface tissue.

15. An apparatus according to claim 13

wherein the operative element includes an electrode to apply energy to the tissue region to form at least one lesion.

16. An apparatus according to claim 15

wherein the operative element applies the treatment agent through a lumen in the electrode.

17. An apparatus according to claim 15

wherein the operative element applies the treatment agent through a lumen that is adjacent to the electrode.

19. A method according to claim 18 further including the step of forming at least one lesion in the tissue region to which the treatment agent is applied.

20. A method according to claim 18 wherein the treatment agent is injected into subsurface tissue.

9. A method for treating a tissue region at or near a sphincter comprising the steps of

deploying an operative element adjacent a tissue region at or near a sphincter, and

applying through the operative element a treatment agent including at least one vanilloid compound into contact with the tissue region.

13. An apparatus for treating tissue at or near a sphincter comprising

an operative element adapted, in use, to be deployed adjacent a tissue region at or near a sphincter,

a source of treatment agent including at least one tissue bulking agent coupled to the operative element to apply the treatment agent into contact with the tissue region.

18. A method for treating a tissue region at or near a sphincter comprising the steps of

deploying an operative element adjacent a tissue region at or near a sphincter, and

applying through the operative element a treatment agent including at least one tissue bulking agent into contact with the tissue region.