Fundoplication apparatus and method

• US 7,156,863 B2
• Filed: 03/15/2001
• Issued: 01/02/2007
• Est. Priority Date: 03/16/2000
• Status: Active Grant

• Current Assignee: Medigus Limited
• Original Assignee: Medigus Limited
• Inventors: Crainich, Lawrence, Sonnenschein, Elazar, Chinnock, Randal, Zonnenshein, Minelu
• Primary Examiner(s): Leubecker; John P.
• Application Number:
  US09/809,291
• Publication Number:
  US 20010056282A1
• Time in Patent Office: 2,119 Days
• Field of Search: 600/173, 600/117, 600/130, 606/219, 606/142, 606/143, 227/181.1, 227/175.1, 227/179.1
• US Class Current: 606/219
• CPC Class Codes: A61B 1/0005 combining images e.g. side-by-side, superimposed or tiled
• CPC Class Codes: A61B 1/00181 for multiple fixed viewing angles A61B1/00193 takes precedence
• CPC Class Codes: A61B 1/00193 adapted for stereoscopic vision
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/2905 flexible

Abstract

An endoscopic device for the partial fundoplication for the treatment of GERD, comprises: a) a distal bending portion and a flexible portion suitable to be positioned in extended shape within the esophagus of a subject; b) a positioning assembly comprising two separate elements, one of which is located on said distal bending portion, and the other on said flexible portion; c) a stapling assembly comprising a staple ejecting device, wherein said staple ejecting device is located on either said bending portion or on said flexible portion, said staple ejecting devices being in working positioned relationship when said two separate elements of said positioning assembly are aligned; and d) circuitry for determining when said two separate elements of said positioning assembly are aligned.

Claims

1. An endoscopic device for carrying out a partial fundoplication, comprising:

a distal bending portion having a distal tip and a flexible portion suitable to be positioned in extended shape within the esophagus of a subject;

a positioning assembly comprising two separate elements, one of which is located on said distal bending portion, and the other on said flexible portion;

a stapling assembly comprising a staple ejecting device, wherein said staple ejecting device is located on either said bending portion or on said flexible portion, said staple ejecting device being in working positioned relationship when said two separate elements of said positioning assembly are aligned; and

circuitry for determining when said two separate elements of said positioning assembly are aligned.

2. An endoscopic device according to claim 1, wherein the stapling assembly further comprises an anvil, wherein either said anvil or said staple ejecting device is located on said bending portion, and the other is located on said flexible portion, said anvil and said staple ejecting device being in working positioned relationship when the two separate elements of the positioning assembly are aligned.

3. An endoscopic device according to claim 2, wherein the portion of the stapling assembly located on the distal bending portion is located on the distal tip.

4. An endoscopic device according to claim 2, wherein the stapling assembly comprises portions including a staple ejecting device and an anvil, wherein said staple ejecting device and said anvil are located longitudinally displaced from one another along the longitudinal axis of said endoscopic device, with at least a part of the flexible portion between them.

5. An endoscopic device according to claim 4, wherein the portions of the stapling assembly are in correct working relationship when one or more alignment/locking pins that are stored either in the staple ejecting device or the anvil are extended and engage and lock into receptacles that have been provided on the other portion of said stapling assembly.

6. An endoscopic device according to claim 5, wherein the alignment/locking pins can be extended and retracted from the portion of the stapling assembly in which they are stored.

7. An endoscopic device according to claim 6, wherein a dual rack and single pinion system is employed to provide the motion of the alignment/locking pins.

8. An endoscopic device according to claim 5, wherein the alignment/locking pins can be locked and released from the receptacles that are provided in the portion of the stapling assembly.

9. An endoscopic device according to claim 5, wherein two alignment/locking pins are provided.

10. An endoscopic device according to claim 5, wherein the alignment/locking pins are stored in the anvil.

11. An endoscopic device according to claim 5, wherein the flexible portion is an articulation section and wherein the alignment/locking pins are manufactured such that the pin tips can be broken by the force exerted by unbending the articulation section.

12. An endoscopic device according to claim 4, wherein either the staple ejecting device or of the anvil is located proximately to the proximal end of the flexible portion and the other portion of the stapling assembly is located proximately to the distal end of said flexible portion.

13. An endoscopic device according to claim 12, wherein the staple ejecting device is located proximately to the proximal end of the flexible portion and the anvil is located on the distal tip of said flexible portion.

14. An endoscopic device according to claim 4, wherein either the staple ejecting device or the anvil is located on the flexible portion of the endoscopic device and the other portion of the stapling assembly is located proximately to the distal end of said flexible portion.

15. An endoscopic device according to claim 4, wherein either the staple ejecting device or the anvil is located on the flexible portion.

16. An endoscopic device according to claim 4, wherein the flexible portion is an articulation section.

17. An endoscopic device according to claim 16, wherein the articulation section is a two-way articulation section.

18. An endoscopic device according to claim 16, wherein the articulation section is a four-way articulation section.

19. An endoscopic device according to claim 16, wherein activation of the articulation section causes the portions of the stapling assembly to be brought into correct working relationship.

20. An endoscopic device according to claim 4, wherein the staple ejecting device contains a staple cartridge containing one or a plurality of arrays of staples each array consisting of one or a plurality of staples.

21. An endoscopic device according to claim 20, wherein the arrays of staples are fired by staple pushers actuated by cams actuable by proximal mechanism.

22. An endoscopic device according to claim 20, wherein the staple cartridge is indexable after the firing of each of the arrays of staples by the action of a proximal actuating device.

23. An endoscopic device according to claim 20, wherein the number of the arrays of staples is three and the number of staples in each of said arrays is five.

24. An endoscopic device according to claim 20, wherein the staples of each array are arranged in three rows with the pinholes aligned with the middle row.

25. An endoscopic device according to claim 4, comprising safety means for disabling the operation of the staple ejecting device when the two separate portions of the stapling assembly are not aligned.

26. An endoscopic device according to claim 2, wherein the staple ejecting device is a staple cartridge, said endoscopic device comprising a transducer, that transmits only, or receives only, or both transmits/receives, mounted into either the anvil or said staple cartridge.

27. An endoscopic device according to claim 1, comprising safety means for disabling the operation of the staple ejecting device when the two separate elements of the positioning assembly are not aligned.

28. An endoscopic device according to claim 1, comprising viewing means.

29. An endoscopic device according to claim 28, wherein the viewing means comprise a video camera.

30. An endoscopic device according to claim 28, wherein the viewing means comprise illumination apparatus.

31. An endoscopic device according to claim 1, comprising one or more channels for supplying one or more of the following:

water and suction.

32. An endoscopic device according to claim 1, further comprising positioning markings to position a portion of the stapling assembly within the esophagus at a location of about 5–

6 cm above the gastroesophageal junction, when said endoscopic device is in working position.

33. An endoscopic device according to claim 32, wherein the portion of the stapling assembly comprises the staple ejecting device.

34. An endoscopic device according to claim 10, wherein the anvil is essentially ring-like in shape.

35. An endoscopic device according to claim 32, wherein the portion of the stapling assembly is displaced along the axis of said endoscopic device by the action of a flexible threaded cable coupled with a female thread located in said portion of said stapling assembly.

36. An endoscopic device according to claim 35, wherein the flexible threaded cable is located within said endoscopic device, and is in contact with the female thread through a slit provided in said endoscopic device.

37. An endoscopic device according to claim 35, wherein the flexible threaded cable is embedded in said endoscopic device, and is in direct contact with the female thread of the portion of the stapling assembly.

38. An endoscopic device according to claim 35, wherein the flexible threaded cable is rotated using a micrometric assembly, thereby to displace the portion of the stapling assembly positioned within the esophagus by a controlled distance.

39. An endoscopic device according to claim 1, wherein the element of the positioning assembly located on the distal bending portion is located on the distal tip.

40. An endoscopic device according to claim 1, comprising two or more separate optical channels that produce two or more distinct views, each of said optical channels consisting of an objective lens and a means of capturing or viewing the image, wherein each objective lens is located at a different position along the length of said endoscopic device.

41. An endoscopic device according to claim 40, in which each of said distinct multiple views may be formed by a single optical channel to produce a monocular view, or by multiple optical channels to produce a binocular or stereoscopic view.

42. An endoscopic device according to claim 41, in which the field of view of each of said optical channels may be of any suitable shape.

43. An endoscopic device according to claim 42, wherein the field of view of each of said optical channels is either circular or rectangular.

44. An endoscopic device according to claim 42, wherein the field of view of each of said optical channels has an angular view of up to more than 180 degrees or more.

45. An endoscopic device according to claim 40, in which the components of said optical channels and said display apparatus are chosen such that said endoscopic device can operate in either the visible, ultraviolet, infrared, or x-ray portions of the electromagnetic spectrum.

46. An endoscopic device according to claim 40, wherein each channel comprises one or more of the following elements:

a) an optical relay system;

b) an occular; and

c) a coupling lens suitable to deliver the image acquired by said objective lens to an image sensor and display apparatus.

47. An endoscopic device according to claim 46, in which said objective lens, occular, and coupling lens have either fixed focal length, multiple focal lengths, or variable focal lengths.

48. An endoscopic device according to claim 40, in which the center of each of said distinct views is at an angle of between 0 and 180 degrees with respect to the mechanical axis of said endoscopic device.

49. An endoscopic device according to claim 1 wherein the staple ejecting device is a stapler cartridge comprising one or more reflectors of ultrasonic waves is created on or within or as an integral part of the surface of said cartridge.

55. A method for positioning the endoscopic device of claim 1 in pre-aligned working position, comprising the steps of:

(One) introducing said endoscopic device through the mouth of a patient and locating the position of the gastroesophageal junction;

(Two) determining the distance from a reference point located on said endoscopic device, and said gastroesophageal junction;

(Three) introducing said endoscopic device into the stomach to a distance below said gastroesophageal junction sufficient to permit the distal tip to be flexed into a position where the fundus is pushed toward the esophagus;

(Four) locking said endoscopic device such that it cannot move relative to the axis of said esophagus;

(Five) determining the position of the portion of the stapling assembly positioned within said esophagus by using its original axial location, said distance determined in step (two), and the radius of curvature of the distal portion of said endoscopic device; and

(Six) displacing said portion of the stapling assembly so as to position it in the range of about 5–

6 cm above said gastroesophageal junction.

50. A method for carrying out an endoscopic partial fundoplication of the fundus of the stomach of a patient, comprising the steps of:

(One) providing an endoscopic device comprising a bending portion and a flexible portion, a positioning assembly comprising two separate elements, and a stapling assembly comprising a staple ejecting device;

(Two) moving the distal tip of said endoscopic device so as to engage said fundus of said patient and to displace it toward the lower part of the esophagus;

(Three) bringing said stapling assembly into working positioned relationship by aligning said two separate elements of said positioning assembly, wherein one of said elements is located on the bending portion and the other on the flexible portion of said endoscopic device;

(Four) determining when said two separate elements of said positioning assembly are aligned by maximizing a signal resulting by bringing them into close positioned relationship, which is received at a signal receiving and analyzing circuit cooperating with said positioning assembly;

(Five) ejecting a plurality of staples from said staple ejecting device, thereby to connect the tissue between them; and

(Six) rotating said endoscopic device relative to the axis of said esophagus and repeating steps (c) through (e) for as many times as needed to achieve the desired partial fundoplication.

51. A method according to claim 50, wherein the stapling assembly further comprises an anvil, wherein either said anvil or said staple ejecting device is located on the bending portion, and the other is located on the flexible portion.

52. A method according to claim 51, wherein the distance between the staple ejecting device and the anvil is between about 0.5 and 1.5 cm.

53. A method according to claim 50, wherein the signal resulting by bringing the two separate elements of said positioning assembly into close positioned relationship is maximized by measuring a physical parameter which is a function of the distance.

54. A method according to claim 50, wherein the signal resulting by bringing the two separate elements of said positioning assembly into close positioned relationship is maximized by correlating it to a measured physical parameter.