Devices and methods for pyloric anchoring

• US 9,498,366 B2
• Filed: 08/09/2004
• Issued: 11/22/2016
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel R., Hall, Gregory W., Campbell-White, Annette, Bajor, Jordan T.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US10/915,716
• Publication Number:
  US 20050055039A1
• Time in Patent Office: 4,488 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.71, 606/151, 606/157, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12086 magnetically detachable
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A device for performing one or more functions in a gastrointestinal tract of a patient includes an anchoring member and at least one actuator, sensor, or combination of both coupled with the anchoring device. The anchoring device is adapted to maintain at least part of the device within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue. Actuators perform any suitable function, such as transmitting energy to tissue, acting as a sleeve to reduce nutrient absorption, occupying space in the stomach, eluting a drug and/or the like. Sensors may be adapted to sense any suitable patient characteristic within the patient'"'"'s gastrointestinal tract, such as pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and/or hemoglobin.

Claims

1. A device for performing one or more functions in a gastrointestinal tract of a patient, the device comprising:

a first anchoring member adapted to maintain a deployed configuration having a fixed shape within a pyloric portion of the patient'"'"'s stomach and to intermittently engage, without directly attaching to, stomach tissue such that the first anchoring member is proximally translatable relative to a pyloric valve whereby a passage between the first anchoring member and the pyloric valve is opened intermittently;

a tissue contacting portion extending from the first anchoring member comprising two or more members which have an opened configuration;

a spanning member having a proximal end attached to the two or more members of the tissue contacting portion and further having a shape adapted to pass at least partially through the pyloric valve;

a second anchoring member coupled to a distal end of the spanning member for maintaining the first anchoring member in intermittent contact with the pyloric valve and further having a shape sized for passage through the pyloric valve after deployment; and

at least one actuator coupled with the first anchoring member and actuated from within the stomach for performing a function from within the patient'"'"'s gastrointestinal tract.

2. A device as in claim 1, wherein the first anchoring member comprises a stomach retention portion having sufficient size and rigidity to prevent passage of the stomach retention portion through the pyloric valve.

3. A device as in claim 2, wherein at least one actuator is coupled with the stomach retention portion.

4. A device as in claim 2, wherein the stomach retention portion is expandable from a first configuration for delivery through an esophagus of the patient to a second configuration for preventing passage of the stomach retention portion through the pyloric valve.

5. A device as in claim 2, wherein the first anchoring member further includes a tissue engagement portion adapted to intermittently engage pyloric stomach tissue without causing significant damage to the tissue.

6. A device as in claim 5, wherein at least one actuator is coupled with the tissue engagement portion.

7. A device as in claim 5, wherein the tissue engagement portion comprises at least one compliant material.

8. A device as in claim 1, wherein the at least one actuator is coupled with the spanning member.

9. A device as in claim 1, wherein the second anchoring member is adapted to reside in a duodenum of the patient.

10. A device as in claim 1, wherein the at least one actuator is coupled with spanning member and the second anchoring member.

11. A device as in claim 1, wherein at least one actuator is coupled with the second anchoring member and is adapted to extend into a small intestine of the patient.

12. A device as in claim 1, wherein at least one of the first anchoring member, the spanning member and the second anchoring member is adapted to change configurations while residing in the gastrointestinal tract.

13. A device as in claim 12, wherein the spanning member is adapted to change its length.

14. A device as in claim 12, wherein the spanning member is adapted to change its diameter.

15. A device as in claim 1, further comprising an attachment mechanism for attaching to a catheter device extended into the stomach to adjust or modify the device.

16. A device as in claim 15, wherein the attachment mechanism comprises a magnet.

17. A device as in claim 1, wherein the first anchoring member includes at least one passage for allowing substances to pass through the device.

18. A device as in claim 1, wherein the at least one actuator comprises one or more substances releasably coupled with the device.

19. A device as in claim 18, wherein the one or more substances are selected from the group consisting of lipids, drugs, enzymes, diagnostic agents, lipids, vitamins, and minerals.

20. A device as in claim 18, wherein the at least one substance is releasably coupled with at least one outer surface of the device such that the substance automatically releases from a surface over time.

21. A device as in claim 20, further comprising a substrate coupled with an outer surface for releasably coupling the at least one substance with the device.

22. A device as in claim 18, wherein the at least one substance is housed within at least one reservoir on the device.

23. A device as in claim 22, wherein the at least one substance is automatically released from the at least one reservoir over time.

24. A device as in claim 22, wherein the at least one substance is released from the at least one reservoir when the device receives a signal from a transmitter outside the patient.

25. A device as in claim 22, wherein the at least one reservoir is adapted to be refilled while the device resides in the gastrointestinal tract.

26. A device as in claim 25, wherein the reservoir are adapted to be refilled via a catheter device passed into the stomach via an esophagus of the patient.