Use of biosurgical adhesive on inflatable device for gastric restriction

• US 7,892,250 B2
• Filed: 11/01/2006
• Issued: 02/22/2011
• Est. Priority Date: 11/01/2006
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Shelton, Fredrick E. IV, Byrum, Randal T., Ortiz, Mark S.
• Primary Examiner(s): Woo; Julian W
• Assistant Examiner(s): Templeton; Christopher L
• Application Number:
  US11/555,322
• Publication Number:
  US 20080103593A1
• Time in Patent Office: 1,574 Days
• Field of Search: 606191-199, 606/213, 606/153, 606/108, 606/202, 623 2365- 2367, 604/96.01, 604/516, 604104-109, 128/898
• US Class Current: 606/195
• 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

Abstract

An apparatus for forming a gastric restriction comprises an applier, an expandable member, and an adhesive. The applier comprises an elongate shaft, and is dimensioned to fit in an esophagus. The applier has a conduit configured to communicate a fluid medium. The expandable member is in fluid communication with the conduit of the applier. The adhesive is positioned on at least a portion of the outer surface of the expandable member. The adhesive is configured to adhere the expanded expandable member to the inner wall of a patient'"'"'s stomach. The expandable member may have a generally toroid configuration with a stoma, such that the expandable member may provide a gastric restriction when expanded and adhered to the inner wall of a patient'"'"'s stomach. The expandable member may thus provide a treatment for morbid obesity by reducing food intake, by reducing stomach volume, or otherwise.

Claims

1. A method of using an applier, an expandable member, and an adhesive to form a gastric flow restriction, wherein the applier comprises an elongate shaft and a distal tip, wherein the elongate shaft comprises a sheath retractable in a longitudinal direction relative to the shaft, wherein the sheath is configured such that the adhesive will not adhere to the sheath despite contact, wherein the applier is dimensioned to fit in an esophagus, wherein the applier has a conduit configured to communicate a fluid medium, wherein the expandable member is in fluid communication with the conduit of the applier, wherein the expandable member is configured to expand from a non-expanded configuration to an expanded configuration, wherein the expandable member has an outer surface, wherein a portion of the expandable member defines an opening that extends through the expandable member, wherein the shaft is positioned within the opening of the expandable member such that the shaft extends through the expandable member, wherein the applier further comprises one or more arms, wherein the one or more arms are configured to deploy about a respective pivot, the method comprising:

(a) inserting the applier and the expandable member through a patient'"'"'s esophagus until the expandable member and at least a portion of the applier reach the patient'"'"'s stomach, wherein the applier is positioned such that the applier extends through the opening of the expandable member with the distal tip positioned below the expandable member during the act of inserting;

(b) retracting the sheath in a longitudinal direction relative to the shaft while the shaft remains positioned within the opening of the expandable member;

(c) deploying the one or more arms, wherein the act of deploying the one or more arms comprises extending the one or more arms in an outward motion sweeping proximally towards the sheath such that extending the one or more arms results in forming a substantially horizontal platform, wherein the substantially horizontal platform is configured and positioned to support the expandable member;

(d) expanding the expandable member within the patient'"'"'s stomach, wherein the act of expanding comprises communicating a fluid medium through the conduit while the shaft remains positioned within the opening of the expandable member, wherein the act of expanding comprises resting at least a portion of the expandable member on the substantially horizontal platform formed by the one or more arms, wherein the distal tip acts as a barrier to prevent the lower portion of the stomach from interfering with the expandable member during the act of expanding the expandable member;

(e) adhering a portion of the outer surface of the expanded expandable member to the inner wall of the patient'"'"'s stomach with the adhesive to form a gastric flow restriction within the patient'"'"'s stomach, wherein at least a portion of the gastric flow restriction is defined by the opening within the expandable member;

(f) retracting the one or more arms, wherein the act of retracting the one or more arms comprises inwardly sweeping the one or more arms such that the one or more arms sweep distally to position the one or more arms substantially parallel to the elongate shaft; and

(g) removing the applier from the patient'"'"'s stomach by removing the shaft from the opening of the expandable member.

2. The method of claim 1, further comprising providing the adhesive on the outer surface of the expandable member, wherein the adhesive is provided on the outer surface of the expandable member prior to the act of inserting the applier and the expandable member through a patient'"'"'s esophagus.

3. A method of forming a gastric flow restriction with an applier, an expandable member, and an adhesive, the applier comprising an elongate shaft, a distal tip, a vacuum lumen extending longitudinally through the elongate shaft and through the distal tip, and an inflation lumen separate from the vacuum lumen, wherein a first portion of the inflation lumen is positioned parallel to the vacuum lumen, wherein a second portion of the inflation lumen is oriented at an angle in relation to the vacuum lumen, wherein the first portion and the second portion of the inflation lumen are connected at an angled bend, wherein the inflation lumen is further configured to be selectively coupled with the expandable member, the expandable member comprising an outer surface, wherein the expandable member is in fluid communication with the inflation lumen, wherein a portion of the expandable member defines an opening extending through the entire expandable member, the method comprising;

(a) applying the adhesive to the outer surface of the expandable member;

(b) inserting the applier and the expandable member through the esophagus of the patient and into the stomach of the patient, wherein the applier is positioned such that the applier extends through the opening of the expandable member with the distal tip positioned below the expandable member during the act of inserting;

(c) drawing the inner walls of the patient'"'"'s stomach towards the expandable member with a suction created by the vacuum lumen;

(d) establishing sealed communication between the inflation lumen and the expandable member;

(e) delivering a fluid to the expandable member to inflate the expandable member, wherein the fluid is delivered through the inflation lumen, wherein the distal tip acts as a barrier to prevent the lower portion of the stomach from interfering with the inflation of the expandable member during the act of delivering a fluid;

(f) stopping the delivery of the fluid to the expandable member after at least a portion of the outer surface of the expandable member adheres to the inner wall of the patient'"'"'s stomach; and

(g) withdrawing the applier through the opening of the expandable member and further through the esophagus of the patient.

4. A method of using an applier and an expandable member to form a gastric restriction, wherein the applier comprises an elongate shaft and a distal tip, wherein the applier is dimensioned to fit in an esophagus, wherein the elongate shaft comprises a vacuum lumen extending longitudinally through the applier, wherein the applier has a conduit configured to communicate a fluid medium, wherein a first portion of the conduit is configured to run parallel to the elongate shaft, wherein a second portion of the conduit is connected to the first portion of the conduit at an angle, wherein the second portion of the conduit is further configured to selectively couple with the expandable member, wherein the applier comprises a pair of deployable arms having an undeployed position and a deployed position, wherein the pair of deployable arms in the undeployed position are positioned parallel to the elongate shaft, wherein the pair of deployable arms in the deployed position are positioned approximately perpendicular to the elongate shaft thereby forming a horizontal platform, wherein the expandable member has an outer surface, a corresponding outer circumference, and a stoma extending therethrough, wherein the expandable member has a toroidal shape, wherein the expandable member is configured to expand from a non-expanded configuration to an expanded configuration, the method comprising:

(a) retaining the pair of deployable arms in the undeployed position;

(b) inserting the applier and the expandable member through a patient'"'"'s esophagus until the expandable member and at least a portion of the applier reach the patient'"'"'s stomach, wherein the applier is positioned through the stoma of the expandable member during the act of inserting the applier and the expandable member with the distal tip positioned below the expandable member during the act of inserting;

(c) deploying the pair of deployable arms from the undeployed position to the deployed position by sweeping the pair of deployable arms outwardly toward the esophagus, wherein the act of deploying forms a horizontal platform with the deployable arms;

(d) drawing the inner walls of a patient'"'"'s stomach towards the expandable member by using a suction communicated through the vacuum lumen;

(e) expanding the expandable member within the patient'"'"'s stomach while the applier is positioned through the stoma of the expandable member, wherein the act of expanding comprises communicating a fluid medium through the conduit, wherein during the act of expanding, at least a portion of the expandable member is supported by the platform formed by the pair of deployable arms, wherein the distal tip acts as a barrier to prevent the lower portion of the stomach from interfering with the expandable member during the act of expanding the expandable member;

(f) adhering a portion of the outer surface of the expanded expandable member to the inner wall of the patient'"'"'s stomach with an adhesive such that an area of contact between the inner wall of the patient'"'"'s stomach and the outer surface of the expandable member defines a band corresponding to the outer circumference of the expandable member to form a gastric flow restriction such that any food traveling from the esophagus to the duodenum passes through the stoma of the expandable member;

(g) retracting the pair of deployable arms, wherein the act of retracting the pair of deployable arms comprises inwardly sweeping the pair of deployable arms such that the pair of deployable arms sweep to position the pair of deployable arms substantially parallel to the elongate shaft; and

(h) withdrawing the applier through the opening of the expandable member and further through the esophagus of the patient.