Method and apparatus for performing sterile medical procedures

• US 6,497,686 B1
• Filed: 04/21/2000
• Issued: 12/24/2002
• Est. Priority Date: 04/21/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Ronald D., Sullivan, Roy H.
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): DAHBOUR, HENRY
• Application Number:
  US09/556,690
• Time in Patent Office: 977 Days
• Field of Search: 604/158, 604/93.01, 604/117, 604/164.01, 604/164.02, 604/164.04, 604/164.06, 604/164.07, 604/167.01, 604/167.06, 604/181, 604/187, 604/212, 604/214, 604/216, 604/258, 604/268
• US Class Current: 604/268
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/3441 with distal sealing means
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

A method and related device for performing sterile medical procedures are disclosed. The method and related device are capable of accessing a sterile environment from a non-sterile environment to perform a medical procedure within the sterile environment. The method and related device can achieve a sterile technique during endoluminal procedures and in uncontrolled and unsterile environments. The device includes an inner hollow member moveably disposed within an outer hollow member. The outer hollow member is adapted to penetrate a boundary separating non-sterile and sterile environments and the inner hollow member is adapted to extend past the outer hollow member and into the sterile environment. A fluid compartment is adapted to be in selective fluid communication with the outer tube such that when the inner member extends past the outer member and into the sterile environment, fluid enters the outer member and the boundary.

Claims

1. A device for performing sterile medical procedures, comprising:

an outer hollow member including a distal end capable of penetrating a boundary layer separating a non-sterile environment from a sterile environment;

an inner hollow member moveably disposed within the outer hollow member, said inner hollow member including a distal end adapted to extend past said outer hollow member distal end and into a sterile environment; and

a compartment defining a reservoir in selective fluid communication with said outer hollow member so as to flow fluid into a portion of said outer hollow member surrounding said inner hollow member.

2. The device of claim 1, wherein said reservoir is for containing a solution to sterilize said inner hollow member and said boundary layer adjacent said outer hollow member.

3. The device of claim 1, wherein the hollow members are tubes.

4. The device of claim 1, wherein said compartment includes a partition separating said reservoir and said outer hollow member.

5. The device of claim 4, wherein said partition includes perforations for selective fluid communication between said reservoir and said outer hollow member.

6. The device of claim 5, further comprising a breakable sealing member for sealing said perforations prior to said selective fluid communication.

7. The device of claim 6, wherein said sealing member includes a plastic membrane.

8. The device of claim 4, further comprising a sealing member adapted to engage with said partition to seal said outer hollow member so that said sterile environment is sealed from said surrounding non-sterile environment.

9. The device of claim 8, wherein said sealing member includes a cap having a first portion adapted to fit within an opening in said partition.

10. The device of claim 9, wherein the partition includes perforations for selective fluid communication between said reservoir and said hollow outer member, and said cap includes a second portion adapted to seal said perforations.

11. The device of claim 1, wherein said compartment is adapted to collapse.

12. The device of claim 1, wherein said inner hollow member is attached to a proximal end of said compartment and extends through said compartment into said outer hollow member, and said compartment is adapted to collapse so that said inner hollow member distal end moves past said outer hollow member distal end and into the sterile environment.

13. The device of claim 12, further comprising a partition forming a distal end of said compartment, said inner hollow member extending from said compartment proximal end through an opening in said partition into said outer hollow member.

14. The device of claim 13, wherein said partition is adapted to disengage from a remainder of said compartment to separate said partition and said outer hollow member from said inner hollow member.

15. The device of claim 1, further comprising a partition forming a distal end of said compartment and separating said reservoir and said outer hollow member, wherein said partition is configured to remain within the non-sterile environment when said outer hollow member penetrates said tissue layer.

16. The device of claim 1, wherein said outer hollow member has a length less than a thickness of said boundary layer.

17. The device of claim 1, further comprising a catheter extending from a proximal end of said compartment, wherein said catheter and said inner hollow member are in fluid communication with each other such that said sterile environment is accessed through said catheter and said inner hollow member.

18. The device of claim 1, wherein said outer hollow member distal end includes a seal adapted to be broken by said inner hollow member distal end.

19. A device for performing a sterile medical procedure, comprising:

an outer hollow member having a sharp distal end for penetrating a tissue separating a sterile environment from a non-sterile environment, the outer hollow member having a seal at the sharp distal end; and

an inner hollow member within the outer hollow member and axially movable with respect to the outer hollow member, the inner hollow member having a sharp distal end for penetrating the seal and the tissue and extending into the sterile environment.

20. The device of claim 19, wherein the outer hollow member has a length so that the outer hollow member does not extend into the sterile environment.

21. The device of claim 19, further comprising a compartment coupled to the inner hollow member, the compartment defining a reservoir in selective fluid communication with a lumen of the outer hollow member.

22. The device of claim 21, wherein the compartment includes a partition defining a distal end of the reservoir.

23. The device of claim 22, wherein the partition includes at least one hole for permitting fluid communication between the reservoir and the lumen of the outer hollow member.

24. The device of claim 23, further comprising a breakable seal between the at least one hole and the lumen of the outer hollow member.

25. The device of claim 21, wherein the compartment is collapsible.

26. The device of claim 19, further comprising a sealing cap configured to seal said outer hollow member after a medical procedure has been performed.

27. The device of claim 19, further comprising a catheter configured to be in fluid communication with a lumen of the inner hollow member to provide access from the non-sterile environment to the sterile environment.

28. The device of claim 19, wherein said outer hollow member is made of a biodegradable material.

29. The device of claim 19, wherein said inner hollow member is configured to be separated from said outer hollow member after a medical procedure is performed.

30. A method of performing a sterile medical procedure, comprising the steps of:

penetrating a boundary with a distal end of an outer hollow member, said boundary separating a non-sterile environment from a sterile environment;

extending a distal end of an inner hollow member past said outer hollow member distal end and into said sterile environment, said inner hollow member moveably disposed within said outer hollow member; and

establishing fluid communication between a compartment for holding a fluid and said outer hollow member such that the fluid flows through a portion of said outer hollow member surrounding the inner hollow member.

31. The method of claim 30, wherein during said step of fluid communication, the fluid sterilizes said inner hollow member and the boundary surrounding said outer hollow member.

32. The method of claim 30, wherein the establishing step includes collapsing said compartment.

33. The method of claim 30, wherein said outer hollow member does not enter said sterile environment during said penetrating step.

34. The method of claim 30, wherein said inner hollow member distal end breaks a seal on said outer hollow member distal end during said extending step.

35. The method of claim 30, wherein the establishing step includes flowing fluid through a partition that separates a reservoir defined by the compartment from said outer hollow member.

36. The method of claim 35, wherein the establishing step includes flowing fluid through perforations of said partition.

37. The method of claim 35, wherein the establishing step includes breaking a fluid seal between said partition and said outer hollow member.

38. The method of claim 35, wherein said partition remains within the non-sterile environment during the extending and establishing steps.

39. The method of claim 30, further comprising the step of disengaging said outer hollow member from said inner hollow member.

40. The method of claim 39, further comprising the step of sealing a proximal end of said outer hollow member so that said sterile environment is sealed from said non-sterile environment after said disengaging step.

41. The method of claim 30, further comprising the step of providing a catheter extending from a proximal end of said compartment, wherein said catheter and said inner hollow member are in fluid communication with each other.

42. The method of claim 41, further comprising the step of accessing said sterile environment through said catheter and said inner hollow member to perform the medical procedure in said sterile environment.

43. A method of performing a sterile medical procedure, comprising the steps of:

penetrating a tissue separating a sterile environment from a non-sterile environment with a sharpened distal end of an outer hollow member, said distal end including a seal; and

extending a sharpened distal end of an inner hollow member in an axial direction with respect to the outer hollow member such that said sharpened distal end penetrates the seal and the tissue; and

further extending the distal end of the inner hollow member into the sterile environment.

44. The method of claim 43, wherein the outer hollow member distal end does not enter the sterile environment during the penetrating step.

45. The method of claim 43, further comprising the step establishing fluid communication between a reservoir and a lumen of the outer hollow member, the reservoir being defined by a compartment coupled to said inner hollow member.

46. The method of claim 45, wherein a partition defines a distal end of the reservoir and the compartment.

47. The method of claim 46, wherein the partition includes at least one hole for establishing the fluid communication between the reservoir and the lumen of the outer hollow member.

48. The method of claim 47, wherein the step of establishing fluid communication includes breaking a seal provided between the at least one hole and the lumen of the outer hollow member.

49. The method of claim 45, wherein the step of establishing fluid communication includes collapsing the compartment.

50. The method of claim 43, further comprising the step of removing said inner hollow tube and sealing said outer hollow member after performing the medical procedure.

51. The method of claim 43, further comprising the step of accessing said sterile environment through a catheter in fluid communication with a lumen of said inner hollow member.

52. A device for performing sterile medical procedures, comprising:

an outer hollow member including a distal end capable of penetrating a boundary layer separating a non-sterile environment from a sterile environment;

an inner hollow member moveably disposed within the outer hollow member, said inner hollow member including a distal end adapted to extend past said outer hollow member distal end and into a sterile environment; and

a compartment defining a reservoir in selective fluid communication with said outer hollow member, wherein said compartment is adapted to collapse.

53. A method of performing a sterile medical procedure, comprising the steps of:

penetrating a boundary with a distal end of an outer hollow member, said boundary separating a non-sterile environment from a sterile environment;

extending a distal end of an inner hollow member past said outer hollow member distal end and into said sterile environment, said inner hollow member moveably disposed within said outer hollow member; and

establishing fluid communication between a compartment for holding a fluid and said outer hollow member such that the fluid flows through said outer hollow member,

wherein the establishing step includes collapsing said compartment.