Methods, instruments and devices for extragastric reduction of stomach volume

• US 8,382,775 B1
• Filed: 04/04/2012
• Issued: 02/26/2013
• Est. Priority Date: 01/08/2012
• Status: Active Grant

• Current Assignee: Vibrynt, Inc.
• Original Assignee: Vibrynt, Inc.
• Inventors: Bender, Theodore M., Makower, Joshua, Shiu, Brian K., Acosta, Pablo G., George, Robert M., Bright, Earl A. II, Limon, Timothy A., Serventi, Lisa, Orbeta, Ed, Early, Scott
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US13/439,059
• Time in Patent Office: 328 Days
• Field of Search: 606/139, 606/144, 606/148, 606/153, 600/205, 600/210, 227/175.1, 604/22
• US Class Current: 606/144
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/0401 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 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/2944 : Translation of jaw members
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Methods, instruments and systems are provided for separating opposite walls of the stomach by extragastric application of suction. Plication of the stomach can be performed between the separated walls after which the separate walls are brought back toward one another. In another aspect, methods, instruments, devices and systems are provided for reducing the effective volume of a stomach by performing one or more extragastric plications of the stomach.

Claims

1. An instrument for use in modifying a patient'"'"'s stomach by operating on the stomach extragastrically to decrease the effective volume of the patient'"'"'s stomach, said instrument comprising:

a first elongate end effector formed at a distal end portion of said instrument, said first elongate end effector having a first operational surface configured to contact an external surface of the patient'"'"'s stomach;

a second elongate end effector formed at a distal end portion of said instrument, said second elongate end effector having a second operational surface configured to contact an external surface of the patient'"'"'s stomach on a location opposite of where the first elongate end effector is configured to contact the external surface of the stomach, and wherein said second operational surface opposes said first operational surface;

a first plurality of suction ports extending along a length of said first elongate end effector from a distal portion of said first end effector to a proximal portion of said first end effector and configured to deliver suction to the external surface of the stomach to engage said first elongate end effector therewith; and

a second plurality of suction ports extending along a length of said second elongate end effector from a distal portion of said second end effector to a proximal portion of said second end effector and configured to deliver suction to the external surface of the stomach to engage said second elongate end effector therewith and wherein said first end effector and said second end effector are movable by actuating a joint mechanism connecting said first and second end effectors.

2. The instrument of claim 1, wherein said first and second pluralities of suction ports are configured to apply suction in an amount sufficient to pull opposite walls of the stomach apart when said first and second elongate end effectors are engaged therewith and said first and second elongate end effectors are moved apart from one another, and wherein the opposite walls are pulled apart without losing engagement of said first and second elongate end effectors therewith.

3. The instrument of claim 2, wherein at least one of said first elongate end effector and said second elongate end effector comprises a clamping mechanism including at least one clamping member configured to assume an unclamped orientation configured so as not to clamp stomach tissue, and a clamped orientation configured to clamp stomach tissue relative to said instrument.

4. The instrument of claim 2, further comprising means for driving a plurality of connectors from said first elongate end effector, through stomach tissue and to said second elongate end effector.

5. The instrument of claim 4, further comprising means for fixing said connectors to maintain a plication in the stomach.

6. The instrument of claim 4, further provided with a layer of material configured to be placed adjacent or between locations where said connectors from said first elongate end effector are configured to pass through the stomach tissue and to said second elongate end effector.

7. The instrument of claim 1, further comprising a plurality of suture drivers extending along a length of said first elongate end effector.

8. The instrument of claim 7, further comprising a plurality of suture anchors extending along a length of said second elongate end effector and opposing said plurality of suture drivers, respectively.

9. The instrument of claim 8, further comprising a plurality of sutures releasably engaged with said plurality of suture drivers, respectively.

10. The instrument of claim 9, wherein each said suture extends through a suture lock releasably provided on said first elongate end effector.

11. The instrument of claim 9, wherein each said suture comprises an anchor mate mounted on a distal end portion thereof, said anchor mate being configured to engage with and connect to said anchor.

12. The instrument of claim 1, further including an expandable implant configured to be implanted in a plication created by said instrument.

13. A system for use in modifying a patient'"'"'s stomach by operating on the stomach extragastrically to decrease the effective volume of the patient'"'"'s stomach, said system comprising:

an engagement instrument comprising;

a first elongate end effector at a distal end portion of said engagement instrument, said first elongate end effector having a first operational surface configured to contact an external surface of the patient'"'"'s stomach;

a second elongate end effector at a distal end portion of said engagement instrument, said second elongate end effector having a second operational surface configured to contact an external surface of the patient'"'"'s stomach on a location opposite of where the first elongate end effector is configured to contact the external surface of the stomach, and wherein said second operational surface opposes said first operational surface;

a first plurality of suction ports extending along a length of said first elongate end effector and configured to deliver suction to the external surface of the stomach to engage said first elongate end effector therewith; and

a second plurality of suction ports extending along a length of said second elongate end effector and configured to deliver suction to the external surface of the stomach to engage said second elongate end effector therewith; and

a stitching instrument comprising;

a third end effector at a distal end portion of said stitching instrument, said third end effector having a third operational surface configured to contact an external surface of the patient'"'"'s stomach;

a fourth end effector at a distal end portion of said stitching instrument, said fourth end effector having a fourth operational surface configured to contact an external surface of the patient'"'"'s stomach on a location opposite of where the third end effector is configured to contact the external surface of the stomach, and wherein said fourth operational surface opposes said third operational surface;

at least one suture driver on the third end effector; and

at least one suture anchor on said fourth end effector opposing said suture driver.

14. The system of claim 13, wherein:

the third end effector is elongated;

the fourth end effector is elongated;

a plurality of suture drivers are spaced along a length of said third elongate end effector; and

a plurality of suture anchors are spaced along a length of said fourth elongate end effector and opposing said plurality of suture drivers, respectively.

15. The system of claim 14, wherein said first and second pluralities of suction ports are configured to apply suction in an amount sufficient to pull opposite walls of the stomach apart when said first and second elongate end effectors are engaged therewith and said first and second elongate end effectors are moved apart from one another,

wherein at least one of said first and second elongate effectors is configured with a clamping mechanism to mechanically clamp stomach wall tissue, and

wherein the opposite walls are pulled apart without losing engagement of said first and second elongate end effectors therewith.