Device and implantation system for electrical stimulation of biological systems

• US 8,543,210 B2
• Filed: 01/25/2009
• Issued: 09/24/2013
• Est. Priority Date: 01/25/2008
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US12/359,317
• Publication Number:
  US 20090264951A1
• Time in Patent Office: 1,703 Days
• Field of Search: 607/40, 607126-131
• US Class Current: 607/40
• CPC Class Codes: A61B 5/6879 Means for maintaining contact with the body A61B5/6847 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.

Claims

1. An implantable device for stimulating the smooth muscles or nerves inside the body, comprising:

a stimulating electrode;

a stimulator for generating pulses and delivering the generated pulses to said smooth muscles or nerve through the stimulating electrode;

an anchoring unit, having a base, attached to said stimulator, wherein said anchoring unit has a pre-deployment shape and a post deployment shape, wherein said post deployment shape is different than the pre-deployment shape, wherein said anchoring unit is capable of anchoring said stimulator to an implant site proximate to said smooth muscles or nerve, and wherein said anchoring unit is capable of puncturing a wall of an organ at a puncture site, wherein said anchoring unit is capable of foreshortening upon deployment of said device in the wall of an organ to pull the device deeper into said wall of the organ, and wherein, upon being pulled deeper into said wall, the base of said anchoring unit is adapted to seal said puncture site;

a power source; and

a microcontroller for instructing the stimulator to selectively generate said pulses.

2. The device of claim 1, wherein said anchoring unit is further used to facilitate puncture at the implant site for deployment of said device.

3. The device of claim 1, wherein, upon deployment of said device into an implant site, a shape of said anchoring unit changes to a predetermined shape, said predetermined shape being determined according to the implant site.

4. The device of claim 3, wherein the shape of said anchoring unit changes to any one of a T-bar, a ship anchor, a spiral disc, a hook, a spiral loop, a loop or any non-linear shape capable of anchoring.

5. The device of claim 1, wherein said device comprises more than one anchoring unit and said more than one anchoring unit each assume either similar or different shapes upon deployment.

6. The device of claim 1, wherein said device comprises a sensor module with a sensing electrode or sensor for detecting a change in physiological parameters.

7. The device of claim 6, upon deployment of said device into an implant site, the shape of said sensing electrode changes to a predetermined shape, said predetermined shape being determined according to the implant site.

8. The device of claim 6, wherein the shape of said sensing electrode changes to any one of a spiral shape, an acute angular shape, a J-shape, a U-shape or a hook.

9. The device of claim 6, wherein said sensing electrode or sensor is configured as a disk attached to one surface of said device.

10. The device of claim 1, wherein upon deployment of said device into an implant site, a shape of said stimulating electrode changes to a predetermined shape, said predetermined shape being determined according to the implant site.

11. The device of claim 10, wherein the shape of said stimulating electrode changes to any one of a spiral shape, a hook, a double hook, a J-shape or a U-shape.

12. The device of claim 1, wherein said stimulating electrode is configured as a disk attached to one surface of said device.

13. The device of claim 1, wherein said anchoring unit is used to deliver said stimulus pulses to the smooth muscles or the nerve.

14. The device of claim 6, wherein said sensing electrode is used to deliver said stimulus pulses to the smooth muscle or the nerve and detect changes in physiological parameters.

15. The device of claim 1, wherein said anchoring unit is also used to detect changes in physiological parameters.

16. The device of claim 1, wherein one electrode unit comprises the stimulating electrode, and the anchoring unit.

17. The device of claim 6, wherein one electrode unit comprises the stimulating electrode, the sensing electrode, and the anchoring unit.

18. The device of claim 1 and claim 6 where the anchoring unit, the sensing electrode or the stimulating electrode are made of shape memory alloys.

19. The device of claim 6, wherein said physiological parameters include at least one of pH, pressure, peristalsis, temperature, impedance, motion, flow, electrical activity, chemical activity, hormonal activity, and neural activity or muscular activity.

20. A catheter system for containing, delivering, and implanting a device for stimulating the smooth muscles or nerves inside the body, comprising:

a catheter having a housing further comprising

a stimulating electrode;

a stimulator for generating pulses and delivering the generated pulses to said smooth muscles or nerves through the stimulating electrode;

a power source; and

a microcontroller for instructing the stimulator to selectively generate said pulses; and

an anchoring unit, having a base, attached to said stimulator, wherein said anchoring unit is capable of puncturing a wall of an organ at a puncture site, wherein said anchoring unit is capable of foreshortening upon deployment of said device in the wall of the organ to pull the device deeper into said wall of the organ, and wherein, upon being pulled deeper into said wall, the base of said anchoring unit is adapted to seal said puncture site.

21. The catheter system of claim 20, wherein, upon deployment of said device into an implant site, a shape of said anchoring unit changes to a predetermined shape, said predetermined shape being determined according to the implant site.

22. The catheter system of claim 21, wherein the shape of said anchoring unit changes to any one of a T-bar, a ship anchor, a spiral disc, a hook, a spiral loop, a loop or non-linear form shape capable of anchoring.