Method and apparatus for augmentation of a sphincter

• US 7,833,281 B2
• Filed: 12/15/2005
• Issued: 11/16/2010
• Est. Priority Date: 12/15/2004
• Status: Active Grant

• Current Assignee: Indiana University Research & Technology Corporation (Indiana University)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Lehman, Glen A., Rucker, Brian K.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US11/300,911
• Publication Number:
  US 20060142789A1
• Time in Patent Office: 1,797 Days
• Field of Search: 623/23.65, 623/23.69, 623/23.7, 623/23.72, 606/200, 606/157, 604/57, 604/59, 604/60
• US Class Current: 623/23.7
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence

Abstract

A system and method for delivering one or more implantable members, such as metal coils, via an introducer member, such as an endoscopic needle, into a space created within the submucosal layers of the LES to augment and bulk the sphincter to improve compliance in patients with gastroesophageal reflux disease. The implantable member comprises a first substantially straightened configuration when carried by the introducer member, whereby it assumes a more curvilinear or coiled configuration following deployment such that it expands against adjacent submucosal tissue, creating a bulge at the implantation site. In another embodiment, the implantable member can serve as an anchoring port for sutures or other elements introduced for gastroplication of the LES to create tissue folds that increase sphincter compliance. The implantable members may be configured to include an external portion that interconnects with an adjacent implantable member, thereby creating tension that also increases compliance of the LES.

Claims

1. A medical apparatus for adding bulk to the lower esophageal sphincter of a patient, comprising:

an elongate introducer member including a distal end configured for penetrating tissue and a first passageway extending therethrough;

one or more resilient implantable members, each said implantable member being constrainable by the introducer member into an elongate first configuration from an expanded second configuration, the medical apparatus comprising a mechanism configured to urge the one or more implantable members from the introducer member into the tissue of the lower esophageal sphincter, the one or more implantable members being adapted to resiliently expand toward the expanded second configuration upon deployment from the introducer member, said one or more implantable members being configured to expand into static contact with surrounding tissue of the lower esophageal sphincter on implantation to push against the surrounding tissue of the lower esophageal sphincter, so that expansive force by said one or more implantable member on the tissue is in equilibrium with containing force exerted by the tissue on said one or more implantable member, the second configuration being substantially more curvilinear in shape than the first configuration,

wherein said apparatus includes a means for separating tissue and creating a pocket within the submucosal layers sufficient for implantation of at least one of the one or more implantable members.

2. The medical apparatus of claim 1, wherein the introducer member comprises a coaxial outer sheath and a needle portion extendable therefrom, the needle member being sized and configured for introduction through an endoscope.

3. The medical apparatus of claim 1, wherein the proximal end of the apparatus is adapted for connecting a fluid reservoir that communicates with the first passageway for the infusion of fluids through the introducer member.

4. The medical apparatus of claim 1, further comprising a second passageway.

5. The medical apparatus of claim 4, wherein the second passageway communicates with an infusion port such that fluid may be infused from the distal end of the introducer member while at least one of the one or more implantable members is disposed within the first passageway.

6. The medical apparatus of claim 1, wherein the implantable member is preloaded in the first passageway.

7. The medical apparatus of claim 1, wherein the first passageway includes a plurality of implantable members disposed therein.

8. The medical apparatus of claim 1, further comprising a pusher member configured for deploying the one or more implantable members from the first passageway.

9. The medical apparatus of claim 1, wherein the implantable member comprises a coiled configuration when in the second configuration, said coiled configuration comprising said coil looped around on itself in a plurality of loops, said loops being in contact with each other.

10. The medical apparatus of claim 1, wherein the implantable member comprises a serpentine member in the second configuration.

11. The medical apparatus of claim 1, wherein the implantable member comprises an irregular shape in the second configuration.

12. The medical apparatus of claim 1, wherein the implantable member is adapted to retract in at least one dimension, while expanding in at least another dimension when deployed into the second configuration.

13. The medical apparatus of claim 12, wherein the change in the width to length ratio of the implantable member when deployed is greater than 50%.

14. The medical apparatus of claim 12, wherein the change in the width to length ratio of the implantable member when deployed is greater than 100%.

15. The medical apparatus of claim 12, wherein the change in the width to length ratio of the implantable member when deployed is greater than 1000%.

16. The medical apparatus of claim 1, wherein the implantable member comprises a superelastic material configured into a helically coiled structure.

19. The medical apparatus of claim 1, wherein the implantable member is enclosed in a bag.

20. The medical apparatus of claim 1, wherein the implantable member includes a plurality of attached fibers extending therefrom.

21. The medical apparatus of claim 20, wherein said fibers are adapted to elicit a biological response within the sphincter tissue.

22. The medical apparatus of claim 2, wherein said coaxial sheath and needle portion have a length sufficient to move through an endoscope placed through the esophagus to the gastroesophageal junction.

24. The medical apparatus of claim 1, wherein in said second configuration said implantable member has approximately diametrically-opposed portions that are adapted to contact and keep separate portions of tissue of said sphincter when said implantable member is within said sphincter.

25. The medical apparatus of claim 1, wherein the implantable member comprises stainless steel or a superelastic alloy.

17. A medical apparatus for introduction into the submucosal space of the lower esophageal sphincter of a patient, comprising:

an elongate needle member and a coaxial outer sheath sized and configured for introduction through a flexible endoscope, the needle member including a distal end and a first passageway extending therethrough;

at least one implantable member;

wherein the at least one implantable member is constrainable into a first substantially linear configuration for introduction through the first passageway of the needle member, and in said first configuration said implantable member is substantially straight and has a substantially constant external diameter;

and wherein the at least one implantable member includes a shape memory such that it is adapted to assume a second configuration upon deployment from the needle member, the at least one implantable member comprising a plurality of bends such that it is adapted to create a volumetric expansion of the submucosal space when implanted therein,

and wherein the assumption of said second configuration includes maintaining said external diameter as substantially constant while said implantable member curls into a plurality of loops, said loops in contact along at least a portion of their respective exteriors.

18. The medical apparatus of claim 17, wherein the needle member includes an outer surface configured for enhanced ultrasonic reflectivity, said configuration of said outer surface being non-mobile with respect to said needle member.

23. The medical apparatus of claim 18, wherein said needle includes a pattern of indentations about a distal portion of said needle, said pattern of indentations providing said enhanced reflectivity.

26. The medical apparatus of claim 18, wherein said outer surface has a plurality of flat surfaces linearly arranged that provide enhanced ultrasonic reflectivity.

34. The medical apparatus of claim 17, wherein said at least one implantable member includes a coil having an unoccupied lumen throughout.

27. A medical apparatus for adding bulk to the lower esophageal sphincter of a patient, comprising:

an elongate introducer member including a distal end configured for penetrating tissue and a first passageway extending therethrough;

one or more resilient implantable members, each said implantable member being constrainable by the introducer member into an elongate first configuration from an expanded second configuration, the medical apparatus comprising a mechanism configured to urge the one or more implantable members from the introducer member into the tissue of the lower esophageal sphincter, the one or more implantable members being adapted to resiliently expand toward the expanded second configuration upon deployment from the introducer member, said one or more implantable members being configured to expand into contact with tissue of the lower esophageal sphincter on implantation, so that force by said one or more implantable member on the tissue is in equilibrium with force exerted by the tissue on said one or more implantable member, the second configuration being substantially more curvilinear in shape than the first configuration,

wherein at least one of said implantable members is configured to be anchored in the lower esophageal sphincter by piercing the lower esophageal sphincter with said at least one implantable member or a suture connected to said at least one implantable member.

28. The apparatus of claim 27, wherein the suture has a continuous loop that is anchored by adjacently placed implantable members.

29. The apparatus of claim 27, wherein the suture is a single length affixed to a first of said implantable members and looped through a second of said implantable members.

30. The apparatus of claim 27, wherein a first and a second of said implantable members each include a respective external portion, said external portions adapted to engage with each other when said implantable members are in tissue of the lower esophageal sphincter.

31. The apparatus of claim 30, wherein the external portion of the first implantable member is a hook portion and the external portion of the second implantable member is a loop portion, said hook portion and said loop portion being adapted to be coupled to thereby tighten the sphincter.

32. The apparatus of claim 27, wherein at least one of said external portions of said first and second implantable members comprises a material or outer coating that is resistant to degradative substances.

33. The apparatus of claim 27, wherein a first and a second of said implantable members are interconnected by a single interconnecting portion.