Surgical device for controlled anchoring in the intestine

• US 9,980,727 B2
• Filed: 07/05/2012
• Issued: 05/29/2018
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Charam Khosrovaninejad
• Original Assignee: Charam Khosrovaninejad
• Inventors: Khosrovaninejad, Charam
• Primary Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/234,834
• Publication Number:
  US 20140222039A1
• Time in Patent Office: 2,154 Days
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00995 having a thin film
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

The present invention relates to a surgical anchor device (1) suitable for being anchored on the mucous membrane of the inner wall of the intestine (10), the device comprising a temporary anchor element (2) presenting anchoring that can be modified in controlled manner and comprising a first substantially cylindrical multiply-perforated wall presenting properties of radial elasticity whereby said first wall presents an outer diameter that can be varied in controlled manner, the device being characterized in that at least a portion of the inner surface of said first wall (2a) is lined with an independent leakproof inner sheath having only its longitudinal ends (3a, 3b) fastened to said anchor element (2) in such a manner as to define a suction chamber (5) between said inner sheath (3) and said first wall, said temporary anchor element (2) being coupled to a flexible or semi-rigid tube referred to as an “injection-suction” tube (6), extending outside said anchor element (2), an open end (6a) of said injection-suction tube opening out into said suction chamber (5) enabling air to be injected into or sucked out from said suction chamber.

Claims

1. A surgical anchor device suitable for being anchored in the mucous membrane of an intestinal wall, the surgical anchor device comprising a temporary anchor element for anchoring to said mucous membrane, that is capable of being modified in a controlled manner, comprising at least a first semi-rigid hollow longitudinal element defining a first wall in the form of a first surface of revolution about a longitudinal axis having a first cylindrical multiply-perforated main portion of circular section, said first semi-rigid hollow longitudinal element being made of a material that gives it properties of radial elasticity such that it is capable of being compressed radially into a radially retracted position, and is capable of adopting a maximally radially expanded position after radial compression has been released, whereby said first wall presents a first outer diameter that is capable of being varied between:

a minimum first outer diameter in said radially retracted position of, at most, 20 mm; and

a maximum first outer diameter in said maximally radially expanded position;

wherein at least a portion of a length of said first wall is lined with an independent leak proof layer forming an inner sheath, only opposing longitudinal ends of said inner sheath being fastened in a leak tight manner to said cylindrical main portion of said first wall at each of said opposing longitudinal ends of said inner sheath with first leak tight fasteners so that said inner sheath is radially expandable, together with said first leak tight fasteners, where said inner sheath is fastened to said first wall, so as to define a suction chamber between said inner sheath and said first wall, said temporary anchor element being coupled to a flexible or semi-rigid injection-suction tube extending outside said temporary anchor element, an open end of said flexible or semi-rigid injection-suction tube opening out into said suction chamber; and

wherein sucking and injecting air in said suction chamber and between said first wall and said intestinal wall, through said flexible or semi-rigid injection-suction tube enables control of a position of said first wall with respect to the intestinal wall, in attracting said intestinal wall against said first wall by sucking air from said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube, and, respectively, in separating said intestinal wall from said first wall by injecting air in said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube; and

wherein said temporary anchor element comprises one or more enteral prostheses of a stent type, said one or more enteral prostheses comprising a mesh of spiral-wound metal, or elastomer wires, or yarns.

2. The surgical anchor device according to claim 1, wherein said inner sheath is constituted by a leak proof film forming a flexible tubular wall.

3. The surgical anchor device according to claim 1, wherein the open end of said flexible or semi-rigid injection-suction tube opening out into said suction chamber is constituted by a multiply-perforated tube portion extending inside said suction chamber.

4. The surgical anchor device according to claim 3, wherein said multiply-perforated tube portion is in the form of a Z-shaped line and running helically about said longitudinal axis along said suction chamber and stuck to a cylindrical inner surface of said temporary anchor element.

5. The surgical anchor device according to claim 1, wherein said first leak tight fasteners are annular walls, and wherein the open end of said flexible or semi-rigid injection-suction tube, opening out into said suction chamber, passes in a leak tight manner through one of said annular first leak tight fasteners, at one of the opposing longitudinal ends of said inner sheath.

6. The surgical anchor device according to claim 5, wherein said first leak tight fasteners are annular elastomer adhesive gaskets.

7. The surgical anchor device according to claim 1, further comprising an outer sheath having a tubular wall constituted by a flexible film fastened to said temporary anchor element at a longitudinal end of said temporary anchor element.

8. The surgical anchor device according to claim 7, wherein said outer sheath comprises an extension of said inner sheath extending outside said temporary anchor element.

9. The surgical anchor device according to claim 7, wherein said flexible or semi-rigid injection-suction tube and said outer sheath extend outside said temporary anchor element from the same end of said temporary anchor element.

10. The surgical anchor device according to claim 9, wherein said flexible or semi-rigid injection-suction tube and said outer sheath are secured to each other, said flexible or semi-rigid injection-suction tube being situated outside said outer sheath.

11. The surgical anchor device according to claim 7, wherein said inner and outer sheaths are made of biocompatible synthetic material, having a wall thickness of 0.01 mm to 1 mm.

12. The surgical anchor device according to claim 11, wherein said inner and outer sheaths are made of silicone or polyurethane elastomer materials having a thickness in a range of 0.05 mm to 1 mm, and comprise properties of radial and longitudinal elasticity, and at least said outer sheath presenting shape memory properties and non-stick properties, said outer sheath, at rest, presenting a length downstream from said anchor element of at least 50 cm, and a diameter lying in a range of 18 mm to 45 mm.

13. The surgical anchor device according to claim 1, wherein said temporary anchor element includes a second semi-rigid hollow longitudinal element defining a second wall in the form of a second surface of revolution around said longitudinal axis having a second cylindrical multiply-perforated main portion of circular section, said second wall being arranged coaxially inside said first wall, only longitudinal ends of said second wall being fastened in a leak tight manner to longitudinal ends of said first wall using the first leak tight fasteners which are annular, or second leak tight annular fasteners, at each of said longitudinal ends of said second wall, said second semi-rigid hollow longitudinal element being made of a second material giving it properties of radial elasticity such that it is capable of being compressed radially such that a second outer diameter of said second wall is capable of being varied between:

a minimum second outer diameter that is less than said minimum first outer diameter; and

a maximum second outer diameter that is less than said maximum first outer diameter.

14. The surgical anchor device according to claim 13, wherein said second wall is interposed between said inner sheath and said first wall, and the open end of said flexible or semi-rigid injection-suction tube opens out into said suction chamber between said inner sheath and said second wall.

15. The surgical anchor device according to claim 14, wherein each of said first and second semi-rigid hollow longitudinal element includes, at one of the longitudinal ends of each of said first and second walls, respectively, a flared extension defining non-cylindrical parts of said first and second surfaces of revolution with a circular section of a diameter that increases from the end of said first or second wall towards the end of the corresponding said first or second semi-rigid hollow longitudinal element, and the extension of maximum diameter equal to at least 105% of said maximum first outer diameter, said first and second hollow longitudinal elements being engaged one inside the other, and head to tail so that said temporary anchor element has said flared extension at each of its longitudinal ends.

16. The surgical anchor device according to claim 13, wherein said second semi-rigid hollow longitudinal element includes the second wall fitted against an inner surface of said first wall, said first and second walls being of the same length.

17. The surgical anchor device according to claim 1, wherein said first wall comprises

a length of at least 30 mm, and said first outer diameter that is capable of being varied between said first minimum outer diameter in the radially retracted position wall of no more than 10 mm, and said first maximum outer diameter in the maximally radially expanded position lying in the range of 18 mm to 45 mm.

18. The surgical anchor device according to claim 1, further comprising a flared extension disposed at a longitudinal end of the temporary anchor element, said flared extension having a margin to which a yarn is attached;

and wherein said yarn is of a length not less than the length of the flexible or semi-rigid injection-suction tube.

19. The surgical anchor device according to claim 1, wherein said flexible or semi-rigid injection-suction tube is connected at a free longitudinal end of said flexible or semi-rigid injection-suction tube to a connection endpiece connected reversibly, or suitable for being connected reversibly, with a device for injecting or sucking air or liquid, said connection endpiece including a shutter device, and a vacuum indicator device suitable for indicating the degree of vacuum in said suction chamber at an opposing end of said flexible or semi-rigid injection-suction tube.

20. The surgical anchor device according to claim 1, wherein at least one longitudinal end of said first wall comprises a flared extension, defining a non-cylindrical part of said first surface of revolution about said longitudinal axis with a circular section of increasing diameter having a maximum diameter equal to at least 105% of said maximum first outer diameter.

21. The surgical anchor device according to claim 1, wherein said maximum first outer diameter is in a range of 18 mm to 45 mm.

22. The surgical anchor device according to claim 1, wherein all of a cylindrical inner surface of said first wall is lined with said inner sheath.

23. The surgical anchor device according to claim 1, wherein said temporary anchor element presents properties of radial expansion that are controlled as a function of temperature.

24. The surgical anchor device according to claim 1, wherein said temporary anchor element presents properties of radial expansion that are controlled mechanically by an independent instrument.

25. The surgical anchor device according to claim 1, wherein sucking and injecting air in said suction chamber and between said first wall and said intestinal wall, through said flexible or semi-rigid injection-suction tube and through multiple perforations of the multiply-perforated main portion enables control of a position of said first wall with respect to the intestinal wall without changing the radial expansion of said first wall, in attracting said intestinal wall against said first wall by sucking air from said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube and through the multiple perforations, and, respectively, in separating said intestinal wall from said first wall by injecting air in said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube and through the multiple perforations.

26. A surgical anchor device suitable for being anchored in the mucous membrane of the intestinal inner wall, the surgical anchor device comprising a temporary anchor element for anchoring to said mucous membrane, that is capable of being modified in a controlled manner, comprising at least a first semi-rigid hollow longitudinal element defining a first wall in the form of a first surface of revolution about a longitudinal axis having a first cylindrical multiply-perforated main portion of circular section, said first semi-rigid hollow longitudinal element being such that it is capable of being compressed radially into a radially retracted position and is capable of adopting a maximally radially expanded position after radial compression has been released, whereby said first wall presents a first outer diameter that is capable of being varied between:

a minimum first outer diameter in said radially retracted position of at most 20 mm; and

a maximum first outer diameter in said maximally radially expanded position;

wherein at least a portion of a length of said first wall is lined with an independent leak proof layer forming an inner sheath, only opposing longitudinal ends of said inner sheath being fastened in a leak tight manner to said cylindrical main portion of said first wall at each of said opposing longitudinal ends of said inner sheath with first leak tight fasteners so that said inner sheath is radially expandable, together with said leak tight fasteners, where said inner sheath is fastened to said first wall, so as to define a suction chamber between said inner sheath and said first wall, said temporary anchor element being coupled to an injection-suction tube extending outside said temporary anchor element, an open end of said injection-suction tube opening out into said suction chamber;

wherein said first wall is configured to enable sucking or injecting air in said suction chamber and between said first wall and an intestinal inner wall, in sucking or injecting air through said injection-suction tube; and

wherein said temporary anchor element comprises one or more enteral prostheses of a stent type, said one or more enteral prostheses comprising a mesh of spiral-wound metal, or elastomer wires, or yarns.

27. The surgical anchor device according to claim 26, wherein said maximum first outer diameter is in a range of 18 mm to 45 mm.

28. The surgical anchor device according to claim 26, wherein said inner sheath and said first wall are spaced at a distance of 0.2 mm to 5 mm where said inner sheath is fastened to said first wall.

29. The surgical anchor device according to claim 26, further comprising an outer sheath in extension of said inner sheath outside said temporary anchor element, and said inner and outer sheaths have a diameter in the range of 18 mm to 45 mm.

30. The surgical anchor device according to claim 26, wherein said inner sheath is constituted by a leak proof film forming a flexible tubular wall.

31. The surgical anchor device according to claim 26, wherein the open end of said flexible or semi-rigid injection-suction tube opening out into said suction chamber is constituted by a multiply-perforated tube portion extending inside said suction chamber.

32. The surgical anchor device according to claim 31, wherein said multiply-perforated tube portion is in the form of a Z-shaped line and running helically about said longitudinal axis along said suction chamber and stuck to a cylindrical inner surface of said temporary anchor element.

33. The surgical anchor device according to claim 26, wherein said first leak tight fasteners are annular walls, and wherein the open end of said flexible or semi-rigid injection-suction tube, opening out into said suction chamber, passes in a leak tight manner through one of said annular first leak tight fasteners, at one of the opposing longitudinal ends of said inner sheath.

34. The surgical anchor device according to claim 33, wherein said first leak tight fasteners are annular elastomer adhesive gaskets.

35. The surgical anchor device according to claim 26, further comprising an outer sheath having a tubular wall constituted by a flexible film fastened to said temporary anchor element at a longitudinal end of said temporary anchor element.

36. The surgical anchor device according to claim 35, wherein said outer sheath comprises an extension of said inner sheath extending outside said temporary anchor element.

37. The surgical anchor device according to claim 35, wherein said flexible or semi-rigid injection-suction tube and said outer sheath extend outside said temporary anchor element from the same end of said temporary anchor element.

38. The surgical anchor device according to claim 37, wherein said flexible or semi-rigid injection-suction tube and said outer sheath are secured to each other, said flexible or semi-rigid injection-suction tube being situated outside said outer sheath.

39. The surgical anchor device according to claim 35, wherein said inner and outer sheaths are made of biocompatible synthetic material, having a wall thickness of 0.01 mm to 1 mm.

40. The surgical anchor device according to claim 39, wherein said inner and outer sheaths are made of silicone or polyurethane elastomer materials having a thickness in a range of 0.05 mm to 1 mm, and comprise properties of radial and longitudinal elasticity, and at least said outer sheath presenting shape memory properties and nonstick properties, said outer sheath, at rest, presenting a length downstream from said anchor element of at least 50 cm, and a diameter lying in a range of 18 mm to 45 mm.

41. The surgical anchor device according to claim 26, wherein said temporary anchor element includes a second semi-rigid hollow longitudinal element defining a second wall in the form of a second surface of revolution around said longitudinal axis having a second cylindrical multiply-perforated main portion of circular section, said second wall being arranged coaxially inside said first wall, only longitudinal ends of said second wall being fastened in a leak tight manner to longitudinal ends of said first wall using the first leak tight fasteners which are annular, or second leak tight annular fasteners, at each of said longitudinal ends of said second wall, said second semi-rigid hollow longitudinal element being made of a material giving it properties of radial elasticity such that it is capable of being compressed radially such that a second outer diameter of said second wall is capable of being varied between:

a minimum second outer diameter that is less than said minimum first outer diameter; and

a maximum second outer diameter that is less than said maximum first outer diameter.

42. The surgical anchor device according to claim 41, wherein said second wall is interposed between said inner sheath and said first wall, and the open end of said flexible or semi-rigid injection-suction tube opens out into said suction chamber between said inner sheath and said second wall.

43. The surgical anchor device according to claim 42, wherein each of said first and second semi-rigid hollow longitudinal element includes, at one of the longitudinal ends of each of said first and second walls, respectively, a flared extension defining non-cylindrical parts of said first and second surfaces of revolution with a circular section of a diameter that increases from the end of said first or second wall towards the end of the corresponding said first or second semi-rigid hollow longitudinal element, and the extension of maximum diameter equal to at least 105% of said maximum first outer diameter, said first and second hollow longitudinal elements being engaged one inside the other, and head to tail so that said temporary anchor element has said flared extension at each of its longitudinal ends.

44. The surgical anchor device according to claim 41, wherein said second semi-rigid hollow longitudinal element includes the second wall fitted against an inner surface of said first wall, said first and second walls being of the same length.

45. The surgical anchor device according to claim 26, wherein said first wall comprises a length of at least 30 mm, and said first outer diameter that is capable of being varied between said first minimum outer diameter in the radially retracted position of no more than 10 mm, and said first maximum outer diameter in the maximally radially expanded position lying in the range of 18 mm to 45 mm.

46. The surgical anchor device according to claim 26, wherein at least one longitudinal end of said first wall comprises a flared extension, defining a non-cylindrical part of said first surface of revolution about said longitudinal axis with a circular section of increasing diameter having a maximum diameter equal to at least 105% of said maximum first outer diameter.

47. The surgical anchor device according to claim 26, further comprising a flared extension disposed at a longitudinal end of the temporary anchor element, said flared extension having a margin to which a yarn is attached;

and wherein said yarn is of a length not less than the length of the flexible or semi-rigid injection-suction tube.

48. The surgical anchor device according to claim 26, wherein said flexible or semi-rigid injection-suction tube is connected at a free longitudinal end of said flexible or semi-rigid injection-suction tube to a connection endpiece connected reversibly, or suitable for being connected reversibly, with a device for injecting or sucking air or liquid, said connection endpiece including a shutter device, and a vacuum indicator device suitable for indicating the degree of vacuum in said suction chamber at an opposing end of said flexible or semi-rigid injection-suction tube.

49. The surgical anchor device according to claim 26, wherein all of a cylindrical inner surface of said first wall is lined with said inner sheath.

50. The surgical anchor device according to claim 26, wherein said temporary anchor element presents properties of radial expansion that are controlled as a function of temperature.

51. The surgical anchor device according to claim 26, wherein said temporary anchor element presents properties of radial expansion that are controlled mechanically by an independent instrument.

52. The surgical anchor device according to claim 26, wherein sucking and injecting air in said suction chamber and between said first wall and said intestinal inner wall, through said flexible or semi-rigid injection-suction tube and through multiple perforations of the multiply-perforated main portion enables control of a position of said first wall with respect to the intestinal inner wall without changing radial expansion of said first wall, in attracting said intestinal inner wall against said first wall by sucking air from said suction chamber and between said first wall and said intestinal inner wall through said flexible or semi-rigid injection-suction tube and through the multiple perforations, and, respectively, in separating said intestinal inner wall from said first wall by injecting air in said suction chamber and between said first wall and said intestinal inner wall through said flexible or semi-rigid injection-suction tube and through the multiple perforations.

53. A surgical anchor device suitable for being anchored in the mucous membrane of an intestinal wall, the surgical anchor device comprising a temporary anchor element for anchoring to said mucous membrane, that is capable of being modified in a controlled manner, comprising at least a first semi-rigid hollow longitudinal element defining a first wall in the form of a first surface of revolution about a longitudinal axis having a first cylindrical multiply-perforated main portion of circular section, said first semi-rigid hollow longitudinal element being made of a material that gives it properties of radial elasticity such that it is capable of being compressed radially into a radially retracted position, and is capable of adopting a maximally radially expanded position after radial compression has been released, whereby said first wall presents a first outer diameter that is capable of being varied between:

a minimum first outer diameter in said radially retracted position of, at most, 20 mm; and

a maximum first outer diameter in said maximally radially expanded position;

wherein at least a portion of a length of said first wall is lined with an independent leak proof layer forming an inner sheath, only opposing longitudinal ends of said inner sheath being fastened in a leak tight manner to said cylindrical main portion of said first wall at each of said opposing longitudinal ends of said inner sheath with first leak tight fasteners so that said inner sheath is radially expandable, together with said first leak tight fasteners, where said inner sheath is fastened to said first wall, so as to define a suction chamber between said inner sheath and said first wall, said temporary anchor element being coupled to a flexible or semi-rigid injection-suction tube extending outside said temporary anchor element, an open end of said flexible or semi-rigid injection-suction tube opening out into said suction chamber; and

wherein sucking and injecting air in said suction chamber and between said first wall and said intestinal wall, through said flexible or semi-rigid injection-suction tube enables control of a position of said first wall with respect to the intestinal wall, in attracting said intestinal wall against said first wall by sucking air from said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube, and, respectively, in separating said intestinal wall from said first wall by injecting air in said suction chamber and between said first wall and said intestinal wall through said flexible or semi-rigid injection-suction tube; and

wherein said temporary anchor element includes a second semi-rigid hollow longitudinal element defining a second wall in the form of a second surface of revolution around said longitudinal axis having a second cylindrical multiply-perforated main portion of circular section, said second wall being arranged coaxially inside said first wall, only longitudinal ends of said second wall being fastened in a leak tight manner to longitudinal ends of said first wall using the first leak tight fasteners which are annular, or second leak tight annular fasteners, at each of said longitudinal ends of said second wall, said second semi-rigid hollow longitudinal element being made of a material giving it properties of radial elasticity such that it is capable of being compressed radially such that a second outer diameter of said second wall is capable of being varied between;

a minimum second outer diameter that is less than said minimum first outer diameter; and

a maximum second outer diameter that is less than said maximum first outer diameter.

54. The surgical anchor device according to claim 53, wherein said second semi-rigid hollow longitudinal element includes the second wall fitted against an inner surface of said first wall, said first and second walls being of the same length.

55. The surgical anchor device according to claim 53, wherein said second wall is interposed between said inner sheath and said first wall, and the open end of said flexible or semi-rigid injection-suction tube opens out into said suction chamber between said inner sheath and said second wall.

56. The surgical anchor device according to claim 55, wherein each of said first and second semi-rigid hollow longitudinal element includes, at one of the longitudinal ends of each of said first and second walls, respectively, a flared extension defining non-cylindrical parts of said first and second surfaces of revolution with a circular section of a diameter that increases from the end of said first or second wall towards the end of the corresponding said first or second semi-rigid hollow longitudinal element, and the extension of maximum diameter equal to at least 105% of said maximum first outer diameter, said first and second hollow longitudinal elements being engaged one inside the other, and head to tail so that said temporary anchor element has said flared extension at each of its longitudinal ends.