Devices for reconfiguring a portion of the gastrointestinal tract

• US 8,920,437 B2
• Filed: 06/20/2013
• Issued: 12/30/2014
• Est. Priority Date: 03/13/2007
• Status: Expired due to Fees

• Current Assignee: Longevity Surgical, Inc.
• Original Assignee: Longevity Surgical, Inc.
• Inventors: Harris, Peter S., Rabin, Barry Hal
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/923,281
• Publication Number:
  US 20130338680A1
• Time in Patent Office: 558 Days
• Field of Search: None
• US Class Current: 606/139
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• 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 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

The present invention involves new interventional methods and devices for reconfiguring a portion of the gastrointestinal tract. The procedures are generally performed laparoscopically and may generally be described as laparoscopic plication gastroplasty (LPG) in which, after obtaining abdominal access, spaced apart sites on a gastric wall are engaged, approximated and fastened to create one or more tissue folds forming one or more plications projecting into the gastrointestinal space. The serosal tissue may optionally be treated during the procedure to promote the formation of a strong serosa-to-serosa bond that ensures the long-term stability of the tissue plication. These procedures are preferably carried out entirely extragastrically (i.e. without penetrating through the gastrointestinal wall), thereby minimizing the risks of serious complications.

Claims

1. A device for manipulating tissue comprising:

a tool assembly adapted for insertion into an abdominal cavity having a handle assembly positioned at a proximal end and an elongate tubular member having a longitudinal axis, the elongate tubular member being positioned between the tool assembly and the handle assembly, wherein the tool assembly comprises at least two extendible members adjustable between an insertion condition and an extended condition, each of the extendible members having at least one associated tissue engagement mechanism located at a distal end, wherein each tissue engagement mechanism is capable of controllably and selectively piercing tissue at a tissue site, and a staple forming mechanism comprising movable pistons and a stationary anvil positioned centrally of the pistons;

a plurality of staples in a pre-deployed state within the elongate tubular member;

a mechanism for automatically feeding individual staples sequentially from the pre-deployed state into a pre-fire state wherein the staple is positioned between the stationary anvil and movable pistons;

an actuator positioned on the handle assembly comprising a trigger assembly adapted for moving the movable pistons to form and eject a staple held in the pre-fire state; and

an operator-actuated control feature capable of drawing the tissue engagement mechanisms together to form pierced tissue shoulders at each tissue site and approximating the pierced tissue shoulders in proximity to one another by drawing the pierced tissue shoulders towards the longitudinal axis from a position laterally spaced from the longitudinal axis.

2. The device of claim 1, wherein the staples are box-type staples.

3. The device of claim 1, wherein the tissue engagement mechanisms are positionable using a remote actuator.

4. The device of claim 1, wherein the tissue engagement mechanisms are selected from the group consisting of:

hooks, barbs, teeth, clips and t-tags.

5. An interventional instrument for engaging and approximating soft body tissues during an interventional procedure comprising:

an approximating tool assembly having a shaft positionable through a laparoscopic port with a longitudinal axis and with a distal end positionable at an interventional site and at least one internal working channel;

a handle assembly positioned at a proximal end of the shaft;

an actuating mechanism on or in proximity to the handle;

at least two extendible members adjustable between a collapsed condition in which they are substantially confined within the internal working channel and an extended condition in which they extend distally along a longitudinal axis of the working channel and beyond the distal end of the shaft, each extendible member having at least one associated tissue engagement mechanism located at its distal end and being capable of engaging tissue at a tissue engagement site in a manner that allows formation of a tissue shoulder at the tissue engagement site; and

a fastening tool assembly having a stationary anvil positioned at the distal end of the shaft and centrally of movable pistons extendible distally of the anvil;

wherein the actuating mechanism is operatively connected to the extendible members to provide controllable extension of the extendible members along a predefined path distally of the shaft, and additionally comprising an operator actuated control feature that draws the tissue engagement mechanisms together to approximate the tissue shoulders formed at the tissue engagement sites in proximity to one another by drawing the tissue shoulders towards the longitudinal axis from a position laterally spaced from the longitudinal axis.

6. The interventional instrument of claim 5, wherein an outer diameter of the shaft is 15 mm or less.

7. The interventional instrument of claim 5, wherein an outer diameter of the shaft is 12 mm or less.

8. The interventional instrument of claim 5, wherein the extendible members are produced from an elastically deformable material.

9. The interventional instrument of claim 5, wherein the tissue engagement mechanisms are tissue hooks having sharpened points that curve toward the longitudinal axis when the extendible members are in the extended condition.

10. The interventional instrument of claim 5, wherein the extendible members have a non-circular, generally flattened cross sectional configuration.

11. The interventional instrument of claim 5, wherein at least one of the cross-sectional shape, physical dimensions and mechanical properties of the extendible members varies along their length.

12. The interventional instrument of claim 5, wherein the extendible members, in extended condition, include at least two bends having radii of curvature in substantially opposing directions.

13. The interventional instrument of claim 5, wherein the handle assembly additionally comprises a trigger operatively connected to the extendible members, whereby movement of the trigger controllably retracts the extendible members into the working channel.

14. The interventional instrument of claim 5, additionally comprising a rotating collar that allows an orientation of the handle assembly to be independently adjusted by an operator relative to an orientation of the approximating tool assembly.

15. The interventional instrument of claim 5, wherein the handle assembly additionally comprises an actuating mechanism allowing an operator to adjust a span of the extendible members when in the extended condition.

16. An interventional instrument for engaging, approximating and fastening soft body tissues during an interventional procedure comprising:

an approximating tool assembly having a shaft positionable through a laparoscopic port with a longitudinal axis and with a distal end positionable at an interventional site and at least one internal working channel;

a handle assembly positioned at a proximal end of the shaft;

first and second actuating mechanisms on or in proximity to the handle;

at least one elastically deformable extendible member adjustable between a collapsed condition in which it is substantially confined within the internal working channel and an extended condition in which it extends out of the working channel and beyond the distal end of the shaft, whereby the at least one extendible member is operatively connected to the first actuating mechanism to provide controllable extension of the at least one extendible member along a predefined path;

at least one tissue engagement mechanism associated with the at least one extendible member, wherein each tissue engagement mechanism is capable of piercing tissue at a tissue site in a manner that allows formation of a tissue shoulder, a fastening tool assembly having a stationary anvil positioned at the distal end of the shaft and centrally of movable pistons extendible distally of the anvil and operatively connected to the second actuating mechanism to provide extension of the movable pistons; and

an operator actuated control feature that repositions each tissue engagement mechanism to form a pierced tissue shoulder at each tissue site and positions the pierced tissue shoulder in proximity to the distal end of the fastening tool assembly by drawing the pierced tissue shoulder towards the longitudinal axis from a position laterally spaced from the longitudinal axis.

17. The interventional instrument of claim 16, additionally comprising guide channels for slidably retaining staples.

18. The interventional instrument of claim 16, comprising at least two extendible members.