Methods and devices for treating morbid obesity using hydrogel

• US 8,608,642 B2
• Filed: 02/25/2010
• Issued: 12/17/2013
• Est. Priority Date: 02/25/2010
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Burrell, Janna M., Byrum, Randal T., Pool, Larry D., Widenhouse, Christopher W., Koch, Robert Louis Jr.
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/712,466
• Publication Number:
  US 20110207994A1
• Time in Patent Office: 1,391 Days
• Field of Search: 606/151, 606/155, 606/156, 606/158, 606191-195, 606/153, 600/30, 600/37, 604/38, 604/121, 604/135, 604/141, 604/143, 604/152, 604/140, 604/891.1, 604/890.1, 604/892.1, 604/31, 604503-505, 604 65- 67, 128/898
• US Class Current: 600/37
• CPC Class Codes: A61F 2013/00676 hydrogel
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

An environmentally sensitive hydrogel material swells or collapses in response to a parameter such as pH level associated with consumption of food by a patient. This swelling or collapsing is harnessed to treat morbid obesity or some other condition of the patient. The swelling or collapsing of the hydrogel may be used to tighten a gastric band or gastric valve when the patient starts eating; then loosen the band or valve when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to increase the size of a space occupying device in the patient'"'"'s stomach when the patient starts eating; then decrease the size of the space occupying device when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to selectively restrict the absorption of nutrients within a patient'"'"'s gastrointestinal tract, such as in the duodenum.

Claims

1. An apparatus, comprising:

(a) a sensor device configured for implantation within a patient'"'"'s gastrointestinal tract, wherein the sensor device comprises;

(i) a hydrogel that senses a physiological parameter associated with consumption of food by the patient, wherein the hydrogel swells or collapses in response to sensing a physiological parameter associated with consumption of food by the patient, and

(ii) a fluid reservoir containing an actuation fluid, wherein the fluid reservoir is defined by the hydrogel;

(b) a restriction forming device configured for implantation within the patient, wherein the restriction forming device is configured to form a restriction in an anatomical structure of the patient, wherein the restriction forming device is coupled with the sensor device via a conduit such that the restriction forming device and the sensor device are in fluid communication via the conduit, wherein the restriction forming device selectively varies the degree of restriction formed by the restriction forming device based at least in part on whether the hydrogel is in a swelled state or a collapsed state, wherein the restriction forming device contains a fluid, wherein the degree of restriction formed by the restriction forming device is based on an amount of fluid in the restriction forming device, wherein the hydrogel is formulated to swell in response to being exposed to gastric fluids indicating consumption of food by the patient such that swelling by the hydrogel forces actuation fluid from the reservoir toward the restriction forming device to add fluid to the restriction forming device to thereby increase the degree of restriction formed by the restriction forming device; and

(c) a catheter, wherein the catheter couples the restriction forming device with the fluid reservoir of the sensor device such that the fluid reservoir of the sensor device is in communication with the restriction forming device.

2. The apparatus of claim 1, wherein the restriction forming device comprises a gastric band.

3. The apparatus of claim 2, wherein the gastric band comprises a bladder, wherein the size of the restriction formed by the gastric band is based on an amount of fluid in the bladder, wherein the amount of fluid in the bladder is based at least in part on whether the hydrogel is in the swelled state or the collapsed state.

4. The apparatus of claim 1, wherein the sensor device comprises a housing having a first section and a second section, wherein the fluid reservoir is defined in the first section of the housing, wherein the second section of the housing contains the hydrogel, wherein the second section of the housing defines a plurality of openings that permit communication of gastric fluids through the housing to reach the hydrogel.

5. The apparatus of claim 4, wherein the sensor device further comprises a piston disc in the housing, wherein the piston disc is positioned between the hydrogel and the actuation fluid, such that the piston disc provides a movable barrier separating the first section of the housing from the second section of the housing.

6. The apparatus of claim 4, wherein the hydrogel is formulated to swell in response to being exposed to gastric fluids indicating consumption of food by the patient such that swelling by the hydrogel forces actuation fluid from the first section of the housing toward the restriction forming device to add fluid to the restriction forming device to thereby increase the degree of restriction formed by the restriction forming device.

7. The apparatus of claim 1, further comprising a jacket external to the hydrogel, wherein the jacket permits communication of gastric fluids through the jacket to reach the hydrogel.

8. The apparatus of claim 7, wherein the jacket is non-extensible, such that the jacket substantially prevents outward swelling of the hydrogel, thereby forcing inward swelling of the hydrogel.

9. The apparatus of claim 1, wherein the hydrogel has a substantially hollow spherical shape.

10. The apparatus of claim 1, wherein the restriction forming device comprises a gastric sleeve.

11. The apparatus of claim 10, wherein the gastric sleeve comprises a body, wherein the body is formed of a material impregnated by the hydrogel.

12. The apparatus of claim 11, wherein the body comprises a plurality of openings, wherein the size of the openings is based on whether the hydrogel impregnating the body is in the swelled state or the collapsed state, wherein the size of the openings is reduced when the hydrogel impregnating the body is in the swelled state, wherein the reduced size openings restricts absorption of nutrients by the anatomical structure of the patient.

13. The apparatus of claim 1, wherein the hydrogel is responsive to pH levels associated with consumption of food by the patient, such that the hydrogel is in the swelled state or the collapsed state based on a pH level within the patient.

14. An apparatus, comprising:

(a) a sensor device configured for implantation within a patient'"'"'s gastrointestinal tract, wherein the sensor device comprises;

(i) a hydrogel that senses a physiological parameter associated with consumption of food by the patient, wherein the hydrogel swells or collapses in response to sensing a physiological parameter associated with consumption of food by the patient, and

(ii) a fluid reservoir containing an actuation fluid, wherein the fluid reservoir is defined by the hydrogel;

(b) a restriction forming device configured for implantation within the patient, wherein the restriction forming device is configured to form a restriction in an anatomical structure of the patient, wherein the restriction forming device is coupled with the sensor device via a conduit such that the restriction forming device and the sensor device are in fluid communication via the conduit, wherein the restriction forming device selectively varies the degree of restriction formed by the restriction forming device based at least in part on whether the hydrogel is in a swelled state or a collapsed state, wherein the restriction forming device contains a fluid, wherein the degree of restriction formed by the restriction forming device is based on an amount of fluid in the restriction forming device, wherein the hydrogel reservoir is formulated to collapse in response to being exposed to gastric fluids indicating consumption of food by the patient such that collapsing by the hydrogel reservoir forces actuation fluid from the reservoir toward the restriction forming device to add fluid to the restriction forming device to thereby increase the degree of restriction formed by the restriction forming device; and

(c) a catheter, wherein the catheter couples the restriction forming device with the fluid reservoir of the sensor device such that the fluid reservoir of the sensor device is in communication with the restriction forming device.