Use of biosurgical adhesive as bulking agent

• US 7,914,511 B2
• Filed: 10/18/2006
• Issued: 03/29/2011
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Rund, Derek, Powell, Darrel M., Ortiz, Mark S., Shelton, Frederick E. IV
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US11/550,628
• Publication Number:
  US 20080154228A1
• Time in Patent Office: 1,623 Days
• Field of Search: 604/502, 604/506, 604/513, 604/516, 606/213, 606/215, 606/216
• US Class Current: 604/506
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• 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 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially

Abstract

An exemplary method of reducing the volume of a stomach comprises providing an adhesive applier and a biocompatible adhesive. The exemplary method further comprises introducing at least a portion of the adhesive applier into the stomach and dispensing the adhesive through the adhesive applier into the stomach. The adhesive may be applied between the submucosa and muscle layers of the stomach to reduce the volume of the stomach. The adhesive may alternatively be applied in layers onto the inner surface of the stomach. Alternatively, a non-expandable member may be introduced into the stomach, and an adhesive may be used to secure the non-expandable member to the stomach. Such uses may provide a treatment for morbid obesity. An adhesive may also be used to provide flow restriction, such as by injecting the adhesive between the submucosa and muscle layers of a cardia or rectum.

Claims

1. A method of reducing the volume of a stomach, wherein the stomach has a first layer comprising a mucosa layer or a submucosa layer and a second layer adjacent to the first layer, the second layer comprising a muscular layer, the method comprising:

(a) performing a Roux-en-Y gastric bypass procedure, wherein the act of performing a Roux-en-Y gastric bypass procedure comprises;

(i) separating a first portion of a patient'"'"'s stomach from a second portion of the patient'"'"'s stomach, wherein the first portion is adjacent to the esophagus and the second portion is adjacent to the patient'"'"'s small intestine,

(ii) forming a pouch with the first portion, and

(iii) joining the patient'"'"'s small intestine to the pouch via an anastamosis;

(b) providing an adhesive applier, wherein the adhesive applier is operable to apply an adhesive;

(c) providing a biocompatible adhesive;

(d) introducing at least a portion of the adhesive applier into the first portion of the stomach;

(e) penetrating the first layer of the first portion of the stomach wherein the act of penetrating the first layer of the first portion of the stomach comprises using the adhesive applier to penetrate the first layer of the first portion of the stomach; and

(f) dispensing the adhesive through the adhesive applier into the first portion of the stomach to reduce or restrict the volume of the first portion of the stomach, wherein the act of dispensing the adhesive comprises dispensing the adhesive in an interstitial location between the penetrated first layer of the first portion of the stomach and the second layer of the first portion of the stomach adjacent to the first layer, wherein act of dispensing is performed after the act of performing the Roux-en-Y gastric bypass procedure.

2. The method of claim 1, wherein the adhesive is generally flexible.

3. The method of claim 1, the method further comprising introducing an imaging device into the stomach.

4. The method of claim 3, wherein the imaging device is introduced into the stomach via an esophagus.

5. The method of claim 3, wherein the imaging device comprises an endoscope.

6. The method of claim 3, wherein the imaging device has a working channel configured to receive a medical instrument, wherein the at least a portion of the adhesive applier is introduced into the stomach via the working channel.

7. The method of claim 1, wherein the adhesive applier is operable to inject the adhesive after penetrating the first layer of the first portion of the stomach, wherein the act of dispensing the adhesive comprises using the applier to inject the adhesive after the act of using the applier to penetrate the first layer of the first portion of the stomach.

8. The method of claim 1, wherein the stomach has a plurality of rugal folds, wherein the act of dispensing the adhesive comprises injecting the adhesive into one or more of the rugal folds.

9. The method of claim 1, wherein the act of dispensing the adhesive comprises dispensing the adhesive at a plurality of locations within the stomach.

10. The method of claim 1, wherein the act of dispensing the adhesive separates at least part of the first layer from the second layer, urging the separated part of the first layer inwardly toward a central region within the stomach to thereby reduce an internal volume defined by the stomach.

11. A method of reducing the volume of a stomach, wherein the stomach has a submucosa layer and a muscle layer, the method comprising;

(a) performing a Roux-en-Y gastric bypass procedure, wherein the act of performing a Roux-en-Y gastric bypass procedure comprises;

(i) separating a first portion of a patient'"'"'s stomach from a second portion of the patient'"'"'s stomach, wherein the first portion is adjacent to the esophagus and the second portion is adjacent to the patient'"'"'s small intestine,

(ii) forming a pouch with the first portion, and

(iii) joining the patient'"'"'s small intestine to the pouch via an anastamosis;

(b) providing an adhesive applier, wherein the adhesive applier is operable to apply an adhesive;

(c) providing a biocompatible adhesive;

(d) introducing at least a portion of the adhesive applier into the first portion of the stomach, wherein the at least a portion of the adhesive applier is introduced into the first portion of the stomach via an endoscope;

(e) penetrating the submucosa layer of the first portion of the stomach to reach an interstitial location between the submucosa layer and the muscle layer; and

(f) dispensing the adhesive through the adhesive applier into the interstitial location between the penetrated submucosa layer and the muscle layer of the first portion, wherein act of dispensing is performed after the act of performing the Roux-en-Y gastric bypass procedure.