Device and method for correction of a painful body defect

• US 6,506,196 B1
• Filed: 03/07/2000
• Issued: 01/14/2003
• Est. Priority Date: 06/22/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: NDO Surgical, Inc.
• Inventors: Laufer, Michael D.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/519,945
• Time in Patent Office: 1,043 Days
• Field of Search: 606/151, 606/153, 606/156, 606/219, 606/220, 606/221, 606/142, 606/143, 606/139, 623/23.65, 623/23.67, 600/207, 600/139, 600/140, 600/146, 227/175.1, 227/175.3, 227/175.8, 128/898, 604/26
• US Class Current: 606/142
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2915 : arcuate shaped guiding means
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2917 : with flexible part
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

Abstract

According to one aspect of the invention, a device for performing a medical procedure includes a first elongated member that is adapted to be positioned inside of an esophagus and a stomach, the first elongated member having a distal flexible portion having a first retracted configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape. The device also includes a second elongated member that is located adjacent to the first elongated member and is adapted to be positioned inside of the esophagus and the stomach, the second elongated member having a proximal flexible portion and a distal flexible portion, the proximal flexible portion having a first expanded configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape, the distal flexible portion having a first retracted configuration and a second expanded configuration defining an arcuate shape, the proximal flexible portion and the distal flexible portion being coaxially aligned with each other when in the first retracted configuration.

Claims

1. A single device for performing a fundoplication procedure, comprising:

a first elongated member that is adapted to be positioned inside of an esophagus and a stomach, the first elongated member having a distal flexible portion having a first retracted configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape; and

a second elongated member that is located adjacent to the first elongated member and is adapted to be positioned inside of the esophagus and the stomach, the second elongated member having a proximal flexible portion and a distal flexible portion, the proximal flexible portion having a first expanded configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape, the distal flexible portion having a first retracted configuration and a second expanded configuration defining an arcuate shape, the proximal flexible portion and the distal flexible portion being coaxially aligned with each other when in the first retracted configuration.

2. The device of claim 1, further comprising:

the first and the second elongated members having a terminating distal end; and

a fastening device located at one of the terminating distal ends.

3. The device of claim 2, wherein the fastening device is a stapling device.

4. The device of claim 2, wherein the fastening device further comprises:

a housing containing a staple;

a contact bar for contacting an activation surface of the staple; and

an indentation so that the staple ends come together as the staple is bent around the contact bar.

5. The device of claim 1, wherein the second elongated member distal flexible portion is located adjacent to the first elongated member when both portions are in the expanded configurations.

6. The device of claim 5, wherein the second elongated member distal flexible portion is aligned with the first elongated member when both portions are in the expanded configurations.

7. The device of claim 1, further comprising:

a third elongated member that is adapted to be positioned inside of the esophagus and the stomach.

8. The device of claim 1, wherein the second elongated member proximal flexible portion is expanded on a first plane and the second distal elongated member distal flexible portion is expanded on a second plane.

9. The device of claim 8, wherein the first plane is approximately orthogonal to the second plane.

10. The device of claim 1, wherein the arcuate shape further includes an arcuate length, which controls the tightness of the resulting fundoplication procedure.

11. The device of claim 1, wherein the device is sterilized.

12. A device for performing a fundoplication procedure, comprising:

a first elongated member that is adapted to be positioned inside of an esophagus and a stomach, the first elongated member having a distal flexible portion having a first retracted configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape;

a second elongated member that is located adjacent to the first elongated member and is adapted to be positioned inside of the esophagus and the stomach, the second elongated member having a proximal flexible portion and a distal flexible portion, the proximal flexible portion having a first expanded configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape, the distal flexible portion having a first retracted configuration and a second expanded configuration defining an arcuate shape, the proximal flexible portion and the distal flexible portion being coaxially aligned with each other when in the first retracted configuration, wherein

the elongated members each having a flexible portion with an internal bladder, a stiffening rib located on the elongated member that extends longitudinally along the length of the elongated members, and a plurality of slits located on the opposite side of the stiffening rib.

13. The device of claim 12, wherein the flexible portion side with the stiffening rib is stiffer than the side with the plurality of slits.

14. A device for performing a fundoplication procedure, comprising:

a first elongated member that is adapted to be positioned inside of an esophagus and a stomach, the first elongated member having a distal flexible portion having a first retracted configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape;

a second elongated member that is located adjacent to the first elongated member and is adapted to be positioned inside of the esophagus and the stomach, the second elongated member having a proximal flexible portion and a distal flexible portion, the proximal flexible portion having a first expanded configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape, the distal flexible portion having a first retracted configuration and a second expanded configuration defining an arcuate shape, the proximal flexible portion and the distal flexible portion being coaxially aligned with each other when in the first retracted configuration, wherein the first and the second elongated members having a terminating distal end; and

a fastening device located at one of the terminating distal ends, wherein the fastening device further comprises;

a housing for containing a staple;

a moveable plate;

a bladder that when inflated, forces the movable plate against the staple and out of the housing against the anvil.

15. A method of performing a fundoplication, comprising the steps of:

inserting a device having first and second elongated members into a patient'"'"'s stomach,

contacting a first portion of the stomach with the first elongated member;

contacting a fundus portion of the stomach with the second elongated member;

moving the distal end of the second elongated member to a position adjacent to the distal end of the first elongated member, thereby moving the fundus portion of the stomach around the esophagus and positioning the fundus portion of the stomach adjacent to the first portion of the stomach; and

fastening the fundus portion that is moved around the esophagus to the first portion of the stomach.

16. The method of claim 15, wherein the fundus portion is wrapped approximately 180 to 360 degrees around the esophagus.

17. The method of claim 15, wherein the fundus portion is wrapped approximately 250 to 290 degrees around the esophagus.

18. The method of claim 15, wherein the fundus portion is wrapped approximately 260 to 280 degrees around the esophagus.

19. The method of claim 15, wherein the fastening step is performed with a staple.

20. The method of claim 15, wherein the contacting steps include the first and the second elongated members moving from a first configuration to a second configuration.

21. The method of claim 20, wherein the second elongated portion includes a distal flexible portion that is expanded on a first plane and a proximal flexible portion that is expanded on a second plane, defining the second configuration.

22. A method of training a person to perform a fundoplication comprising the steps of demonstrating or instructing the method of claim 15.