DEVICES, TOOLS AND METHODS FOR PERFORMING MINIMALLY INVASIVE ABDOMINAL SURGICAL PROCEDURES

• US 20090281377A1
• Filed: 05/28/2009
• Published: 11/12/2009
• Est. Priority Date: 04/19/2006
• Status: Active Grant

• Current Assignee: Vibrynt, Inc.
• Original Assignee: Vibrynt, Inc.
• Inventors: Shiu, Brian K, Bender, Theodore M., Makower, Joshua, Limon, Timothy A., George, Robert M., Rathi, Pankaj, Huss, Beverly, Newell, Matthew B., Uemura, Shuji, Brooks, Narvel M. III, Acosta, Pablo G., Dreissigacker, Marlo, Johnson, Dane A., Lee, Crystine M.
• Granted Patent: US 8,585,733 B2
• Time in Patent Office: Days
• US Class Current: 600/104
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

Abstract

Methods, systems, devices and assemblies are provided for treating a patient by: making an incision or puncture though the patient'"'"'s skin over the abdominal cavity; establishing an initial tract through an opening formed by the incision or puncture; advancing an instrument through the tract; contacting a distal end portion of the instrument against an inner surface of the abdominal cavity; driving at least one stitching needle through the inner surface of the abdominal cavity; continuing the driving until the at least one stitching needle exits the inner surface of the abdominal cavity; anchoring a suture carried by each of the at least one stitching needle to a suture anchor at an exit location, respectively; and applying tension to each of the sutures.

Claims

1. A method of treating a patient said method comprising:

making an incision or puncture though the patient'"'"'s skin;

establishing an initial tract through an opening formed by the incision or puncture and through an abdominal wall of the patient;

inserting a guide member having a flexible distal portion and a distal lip into the initial tract and extending the initial tract to form a delivery tract leading to and following along a portion of the curvature of the diaphragm of the patient;

dilating the opening formed by the incision or puncture and initial tract through the abdominal wall by torquing a distal end of a dilator therethrough, wherein an introducer cannula is mounted over said dilator and a distal end portion of said introducer cannula is passed through the abdominal wall along the tract;

removing said dilator from said introducer cannula and from said patient, while leaving said introducer cannula in position;

passing an obturator, having a delivery conduit mounted thereon, over said guide member and through said introducer conduit;

advancing said obturator and delivery conduit over said guide member to an extent where distal end portions of said obturator and delivery conduit bend and track along a portion of the curvature of the diaphragm followed by said guide member; and

removing said obturator and guide member while leaving said delivery conduit in place, wherein said delivery conduit defines a delivery tract for delivery of at least one or more tools and/or implants.

2. The method of claim 1, further comprising:

advancing an implantation system into said delivery conduit, said implantation system including an implantation device mounted on an implantation instrument and placing a distal end of said implantation device in proximity with a distal end of said delivery conduit;

retracting said delivery conduit relative to said implantation device to expose said implantation device distally of said distal end of said delivery conduit;

contacting an attachment tab portion of said implantation device to a target implantation site in the patient, using said implantation instrument;

visualizing positioning and orientation of at least said attachment tab portion of said implantation device;

upon visual confirmation that said positioning and orientation is satisfactory, driving at least one stitching needle into the target implantation site at an initial location;

continuing said driving until said at least one stitching needle exits the target implantation site at an exit location;

anchoring a suture carried by each said at least one stitching needle to a suture anchor at said exit location, respectively; and

applying tension to each said suture and fixing tension in each said suture, using a suture retainer fixed to said attachment tab portion, at each said initial location, respectively, thereby maintaining tension in each said suture.

3. The method of claim 2, wherein said driving at least one stitching needle comprises driving a plurality of stitching needles, said stitching needles being arranged in at least two rows.

4. The method of claim 2, further comprising:

driving at least one stabilizing pin per each said stitching needle into the target implantation site adjacent each said initial location, respectively, after said contacting an attachment tab portion against the target implantation site, but before said driving at least one stitching needle into the target implantation site at an initial location.

5. The method of claim 2, further comprising cutting an excess portion of each said suture at a location proximal of a location of said suture retainer, respectively.

6. The method of claim 5, further comprising:

connecting a port in fluid communication with said implant;

inserting the port through the incision or puncture;

securing the port to fascia of the patient; and

closing the incision or puncture.

7. The method of claim 1, wherein said establishing an initial tract comprises:

inserting an endoscope into an optical trocar surrounded by an optical cannula;

inserting the optical trocar and endoscope to the incision or puncture;

advancing the optical trocar, optical cannula and endoscope, while viewing at least one of;

the tissues being advanced through, and the tissues surrounding the initial tract being established; and

removing the optical trocar and endoscope after extending the initial tract through the abdominal wall, while leaving the optical cannula in a position extending through the abdominal wall and extending proximally out of the patient;

wherein said inserting a guide member comprises inserting the guide member through the optical cannula.

8. The method of claim 1, comprising viewing advancement of the guide member as the guide member forms the delivery tract and extends toward and around at least a portion of the diaphragm, using fluoroscopy.

9. The method of claim 1, comprising inserting an endoscope into the guide member, and viewing advancement of the guide member through a distal tip of the guide member, using the endoscope inserted therein, as the guide member forms the delivery tract and extends toward and around at least a portion of the diaphragm.

10. The method of claim 1, comprising inserting a rigid member within the flexible distal end portion of the guide member to render at least part of the distal end portion temporarily rigid as the distal end portion travels over a portion of the delivery tract as the delivery tract is formed.

11. The method of claim 10, comprising ensuring that the rigid member is not inserted within the flexible distal end portion of the guide member when the distal end portion contacts the diaphragm.

12. The method of claim 1, wherein, upon completing formation of the delivery tract, the distal tip of the guide member is placed posterior to the left lateral segment of the liver of the patient and anterior to the stomach of the patient.

13. The method of claim 12, further comprising removing the endoscope from the guide member upon completion of the formation of the delivery tract, and delivering a local anesthetic to a target implantation site in the patient through a lumen in the guide member.

14. The method of claim 1, wherein at least a portion of each of the dilator and introducer cannula are transparent said method further comprising inserting an endoscope within the dilator and introducer and viewing at least a portion of the procedure defined by said dilating, through said transparent portions, using said endoscope.

15. The method of claim 1, comprising viewing advancement of said obturator and delivery conduit over said guide member, using fluoroscopy.

16. The method of claim 2, comprising viewing advancement of said implantation device through said delivery conduit using fluoroscopy.

17. The method of claim 2, wherein said retracting said delivery conduit includes, at the same time moving a proximal end portion of said delivery conduit in a direction transverse to a longitudinal axis of said implantation system, wherein a slit in said delivery conduit allows said proximal end portion of said conduit to be slid off of said implantation system so that said implantation system is external of said proximal end portion of said delivery conduit.

18. The method of claim 2, further comprising, prior to said driving at least one stitching needle, inserting an endoscope through said delivery conduit and viewing, through said endoscope, the attachment tab portion relative to the target implantation site to ensure that there is no other tissue interposed between the attachment tab portion and the anatomical structure that the attachment tab is to be fixed to at the surgical implantation site.

19. The method of claim 2, wherein the implantation device is in a contracted configuration upon said advancing an implantation system into said delivery conduit said method further comprising:

expanding said implantation device prior to said driving at least one stitching needle.

20. The method of claim 19, wherein said expanding is performed prior to said visualizing positioning and orientation, and wherein said visualizing positioning and orientation includes visualizing positioning and orientation of an expandable member portion of said implantation device.

21. The method of claim 20, comprising ensuring that said positioning and orientation of said expandable member are satisfactory, prior to said driving at least one stitching needle.

22. The method of claim 21, wherein a satisfactory orientation and positioning of said expandable member includes a superior portion of the expandable member positioned under the left lateral segment of the liver, and an inferior portion of the expandable member is located in the mid-abdomen, below the costal margin of the patient, and in contact with the anterior abdominal wall.

23. The method of claim 2, wherein the target implantation site is the anterior abdominal wall of the patient inferior to the costal margin.

24. A method of treating a patient said method comprising:

making an incision or puncture though the patient'"'"'s skin;

establishing an initial tract through an opening formed by the incision or puncture and through an abdominal wall of the patient;

inserting a guide member having a flexible distal portion and a distal tip into the initial tract and extending the initial tract to form a delivery tract leading to and following along a portion of the curvature of the diaphragm of the patient;

dilating the opening formed by the incision or puncture and initial tract through the abdominal wall by torquing a distal end of a dilator therethrough, wherein an introducer cannula is mounted over said dilator and a distal end portion of said introducer cannula is passed through the abdominal wall along the tract;

removing said dilator from said introducer cannula and from said patient, while leaving said introducer cannula in position;

attaching a cap to a proximal end of the introducer cannula, thereby sealing off the proximal end of the introducer cannula; and

forming a pneumoperitoneum in the abdominal cavity.

25. The method of claim 24, comprising opening a port in said cap and delivering insufflation gas through said introducer cannula.