Endoscopic anchoring device and associated method

• US 20050234512A1
• Filed: 04/19/2005
• Published: 10/20/2005
• Est. Priority Date: 04/19/2004
• Status: Active Grant

• Current Assignee: Granit Medical Innovations LLC
• Original Assignee: Granit Medical Innovations LLC
• Inventors: Nakao, Naomi L.
• Granted Patent: US 7,833,238 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue

Abstract

An endoscopic fastening assembly having a diameter sufficiently small so that the fastening assembly is slidably insertable into a working channel of a flexible or rigid endoscope for performing a fastening operation, comprises one or more surgical anchors within an elongated tubular member configured for delivery and deployment of said anchors. One or more anchors being disposed in a substantially closed pre-deployment configuration inside the tubular body are configured for being delivered and deployed into a target tissue while remaining in a substantially closed configuration, and assuming its open anchoring properties only once embedded in tissue.

Claims

1. An endoscopic fastening assembly configured for securing tissue internal to the body utilizing an endoscope, comprising:

an elongate tubular body provided with a sharp hollow tip coextensive with said tubular body distal end;

one or more anchors disposed inside said elongate tubular body;

an elongate pushing device provided for advancing said anchors in a distally directed motion of said pushing device; and

means for said anchors to be cinched together to provide tissue approximation for securing of said tissue.

2. The endoscopic fastening assembly in accordance with claim 1, wherein said assembly is utilizable in conjunction with a flexible endoscope.

3. The endoscopic fastening assembly in accordance with claim 1, wherein said system is utilizable in conjunction with a rigid endoscope.

4. The endoscopic fastening assembly in accordance with claim 1, wherein said elongate tubular body houses one or more anchors.

5. The endoscopic fastening assembly in accordance with claim 1, whereby said pushing device is slidably disposed inside said elongate tubular body, said pushing device being provided for advancing said anchors in a distal direction towards said tubular body'"'"'s distal end.

6. The endoscopic fastening assembly in accordance with claim 1, whereby said anchors are disposed in a substantially closed pre-deployment configuration within said elongated tubular body.

7. The elongated tubular body in accordance with claim 1, whereby said tubular body is provided with a hollow needle or other sharp tip at its distal end for delivering said anchors into target tissue.

8. The endoscopic fastening assembly in accordance with claim 1 wherein said anchor is made from at least one of metal or plastic.

9. The endoscopic fastening assembly accordance with claim 1 wherein said anchor is made at least partially of a spring biased metal.

10. The endoscopic fastening assembly in accordance with claim 1 whereby said anchor is made at least partially of a shape memory alloy.

11. The surgical anchor in accordance with claim 10 whereby said anchor is made at least partially of a shape memory alloy which displays stress-induced martensite properties.

12. The surgical anchor in accordance with claim 11 whereby said anchor is made at least partially of a shape memory alloy which displays stress-induced martensite properties, at temperatures ranging between 35 and 40 degrees Celsius.

13. The endoscopic fastening assembly in accordance with claim 1 wherein said anchor is elastic and is configured to splay to an open state when ejected from the tubular body under a spring biased force.

14. The endoscopic fastening assembly in accordance with claim 1 whereby said anchor may include an oval shaped body, whereby a plurality of spines are co-joined with said oval body.

15. The surgical anchor in accordance with claim 1, whereby said anchor may be provided with a plurality of wires or spines coupled together by a ring-shaped crimping mechanism.

16. The surgical anchor in accordance with claim 14 whereby the spines are configured and operable to splay out when deployed into a target tissue.

17. The surgical anchor in accordance with claim 14 whereby said anchor spines are configured with sharply pointed curved distal ends.

18. The endoscopic fastening assembly in accordance with claim 1 further comprising a line element coupled to said anchor.

19. The endoscopic fastening assembly in accordance with claim 1 yet further comprising an actuation handle coupled to the pushing device.

20. The endoscopic fastening assembly in accordance with claim 19, wherein the pushing device includes an indexing locking mechanism.

21. The endoscopic fastening assembly in accordance with claim 18 whereby the anchor includes a body and a plurality of spines coupled with the body, the body being provided with an opening for a line element to traverse therethrough.

22. The endoscopic fastening assembly in accordance with claim 1 further comprising multiple anchors that are coupled to one another by a line element.

23. The endoscopic fastening assembly of claim 1 yet further comprising a plurality of anchors disposed end to end in the elongated tubular body.

24. The endoscopic fastening assembly in accordance with claim 1 wherein the elongate tubular body is provided with a passageway traversing longitudinally therethrough for introducing fluid of differing temperatures to be ejected from tubular body'"'"'s distal end, thereby affecting anchor'"'"'s shape and consistency.

34. The surgical anchor in accordance with claim 15 whereby said anchor crimping mechanism and anchor spines are made of the same material.

35. The surgical anchor in accordance with claim 1 whereby said anchor crimping mechanism and anchor spines are made of different materials.

36. The surgical anchor in accordance with claim 11, wherein said anchor spines are made from a shape memory alloy such as Nitinol, enabling said anchor to assume a martensitic state at certain temperatures, and revert to an austenitic state at other, higher temperatures.

38. The line element in accordance with claim 23, whereby said line element may enter through a proximal end of the elongate tubular body, operatively engage with said anchor/s, and exit from said proximal end of said elongate tubular body, or through a port proximate said proximal end.

39. The anchoring system in accordance with claim 1 wherein said elongate tubular body is comprised of a slidable, rigid or semi-rigid material, is provided with a hub on proximal end for connecting to a fluid injection device, and or a connector on proximal end for electric current, and or finger and thumb rings for anchor actuation.

25. An endoscopic fastening assembly configured for securing internal tissues in conjunction with an endoscope, comprising:

one or more expandable anchors configured for being positioned inside a tubular body that fits into a working channel of an endoscope; and

the anchor stored in a collapsed state inside tubular body, and operable to splay to an open state when ejected from said tubular body, said anchor being provided with one or more spines configured for entering and gripping tissue.

26. The surgical anchor in accordance with claim 25 wherein said anchor is formed of a shape memory alloy.

27. The surgical anchor in accordance with claim 26 wherein the shape memory alloy enables induction of a martensitic state for collapsing said anchor for containment and storage inside said elongated tubular body.

28. The surgical anchor in accordance with claim 27, wherein said shape memory alloy is in a martensitic state when the anchor is collapsed, and takes on an austenitic state when the anchor is heated thereby assuming an open configuration.

29. The surgical anchor in accordance with claim 28, wherein said shape memory alloy is heated to an austenitic state generally at a body temperature of a patient'"'"'s tissue into which the anchor is deployed.

30. The surgical anchor in accordance with claim 25, wherein the anchor spine is provided with a curved distal end for gripping a target tissue, curved state of said distal anchor spine being formed at body temperature.

31. The surgical anchor in accordance with claim 26, wherein said anchor'"'"'s assumption of a splayed or open state enables said spines to form an angle between respective spines from their point of origin proximate the and distal to the crimping mechanism, said angle being equal or greater than 60 degrees.

32. The surgical anchor in accordance with claim 25, wherein the shape memory alloy may assume a stress-induced martensitic state.

33. The surgical anchor in accordance with claim 25, wherein the spine has one of a generally straightened or minimally curved distal end, said distal end assuming more of a curve when said anchor is heated.

37. A surgical anchor for fastening tissue internal to the body said anchor being provided with:

one or more spines, said spines being provided with curved, sharp distal ends;

a means for connecting said spines to one another; and

a loop or other opening for coupling said anchor to a line element, said line element being configured for being coupled with one or more anchors.

40. An endoscopic fastening system for securing tissue internal to the body utilizing an endoscope comprising:

an elongated tubular body being provided at a distal end thereof with a needle, and being configured for housing one or more anchors;

a surgical anchor, said anchor comprising a plurality of spines, said anchor being disposed inside said elongated tubular body;

a pushing device slidably disposed inside said elongated tubular body, said pushing device being provided for advancing one or more anchors in a distal direction; and

a line element for coupling two or more anchors.

41. A method for performing surgical operations on internal body tissues of a patient, in accordance with the embodiment of present invention comprising the following steps;

(i) inserting an endoscope through an aperture in the patient'"'"'s body and locating a target tissue;

(ii) pushing an elongate tubular body with needle element attached to a distal end thereof in a direction towards said target tissue;

(iii) pushing said tubular body further in a distal direction, thereby plunging said needle element into said target tissue;

(iv) advancing an first anchor in a distal direction by actuation of a pushing device;

(v) withdrawing said needle from tissue, and retrieving a line element coupled with said anchor to an extracorporeal location;

(vi) reinserting same, or other needle attached to same or other elongate tubular body into a second location, and repeating steps iv and v; and

(v) cinching said line elements together by a ring element or another cinching mechanism practiced in the art, until desired tissue approximation and fastening is achieved.

(vi) the fastening procedure in accordance with the present invention may or may not be repeated during the same intubation.

42. An endoscopic fastening assembly comprising an elongate tubular body having an outer diameter sufficiently small, to be slidably insertable through an endoscope, said elongated tubular body being provided at a distal end thereof with a hollow needle, one or more anchors being disposed inside said elongated tubular body and coupled with a line element, and a push member for pushing said anchors in a distal direction.

43. The endoscopic fastening assembly in accordance with claim 42, wherein an individual line element is provided for an individual anchor.

44. The endoscopic fastening assembly in accordance with claim 42, wherein a common line element is provided for coupling together individual anchors.

45. A method of performing a suturing procedure through a flexible endoscope comprising:

directing at least one expandable anchor through a tubular body positioned in a working channel of an endoscope;

the anchor being in a collapsed state when positioned in the tubular body, and assuming an open, splayed state when ejected from said tubular body;

positioning a distal end of the tubular body into target tissue, and ejecting said anchor into said target tissue.

46. The method in accordance with claim 45, wherein a plurality of anchors is implanted at opposing ends of a target tissue for approximating said tissues, and securing said tissue.

47. The method in accordance with claim 46 further comprising a line element slidably connected to each anchor and including the step of cinching the line elements in order to draw the anchors and thereby the tissue together.

48. The method in accordance with claim 45 wherein the target tissue is a hollow organ and includes the steps of ejecting multiple anchors into said target tissue, drawing said deployed anchors together causing a volume restriction of said hollow organ.