Apparatus for establishing access to the body

• US 7,678,100 B2
• Filed: 09/27/2004
• Issued: 03/16/2010
• Est. Priority Date: 03/06/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Adams, John B., Chin, Yem, Bottcher, Benjamin J., Liu, Clifford M.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Bouchelle; Laura A
• Application Number:
  US10/949,394
• Publication Number:
  US 20050049570A1
• Time in Patent Office: 1,996 Days
• Field of Search: 604/165.01, 604/165.02, 604/523, 604/533, 604/535, 604/538, 604/539, 604/166.01, 604/158, 604/160, 604/164.07, 604/910, 606/108, 128/DIG.26
• US Class Current: 604/533
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An apparatus and method for access to the inside of a body includes a transparent sheath with a radiopaque marking and fastener for securing a guidewire or catheter. The transparent sheath permits objects located within and near the sheath to be visualized with an external imaging system. Objects located near the sheath can also be observed with an imaging device disposed inside the sheath. The radiopaque marker permits accurate positioning of the sheath in the body. The sheath can be inserted into the body over an interventional device. A fastener prevents migration of a guidewire or catheter during the procedure.

Claims

1. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated member configured to maintain the patency of an opening in the human or animal body, the elongated member having a lumen configured to receive at least a portion of a medical device such that the medical device may be moved from a first position to a second position, the elongated member defining a slot in communication with the lumen, the elongated member including a clip disposed adjacent at least a portion of the slot, the slot configured to engage the medical device when the medical device is passed through the slot and is in the second position to restrict longitudinal motion of the medical device with respect to the elongated member, the clip configured to engage the medical device when the medical device is in the second position, the elongated member being made of a transparent material.

2. The sheath of claim 1, wherein the transparent material is a material that is transparent to visible light.

3. The sheath of claim 1, wherein the transparent material is a material that is transparent to x-rays.

4. The sheath of claim 1, wherein the elongated member includes at least one radiopaque marker.

5. The sheath of claim 1, wherein the elongated member includes at least one radiopaque marker disposed on a distal end portion of the elongated member.

6. The sheath of claim 1, wherein the elongated member includes at least one radiopaque marker that is disposed on and parallel to a length of the elongated member.

7. The sheath of claim 1, wherein the medical device is a guidewire.

8. The sheath of claim 1, wherein the medical device is a catheter.

9. The sheath of claim 1, wherein the elongated member defines a longitudinal axis, the elongated member including a distal end face, the distal end face and the longitudinal axis defining an angle of about 90 degrees.

10. The sheath of claim 1, wherein the elongated member defines a longitudinal axis, the elongated member including a distal end face, the distal end face and the longitudinal axis defining an angle of less than 90 degrees.

11. The sheath of claim 1, wherein the slot includes a “

T”

shaped portion.

12. The sheath of claim 1, wherein the slot includes an “

L”

shaped portion.

13. The sheath of claim 1, wherein the lumen is configured to receive at least a portion of an imaging device.

14. The sheath of claim 1, wherein the elongated member includes a band disposed proximate to the slot, the band configured to engage the medical device when the medical device is in the second position.

15. The sheath of claim 1, wherein the clip is configured to directly engage the medical device when the medical device is in the second position.

16. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated member configured to maintain the patency of an opening in the human or animal body, the elongated member defining a proximal end portion, a distal end portion, and a lumen extending from the proximal end portion to the distal end portion, the lumen being configured to receive at least a portion of a medical device such that the medical device may be moved from a first position where the medical device passes through a portion of the lumen defined by the proximal end portion of the elongated member to a second position, the elongated member including a clip disposed on the proximal end portion of the elongated member at least partially adjacent a slot defined by the proximal end portion of the elongated member, the slot being in communication with the lumen, the clip being configured to engage the medical device when the medical device is in the second position and a portion of the medical device is passed through the slot to restrict longitudinal motion of the medical device with respect to the elongated member.

17. The sheath of claim 16, wherein the elongated member is made of a material that is transparent to visible light.

18. The sheath of claim 16, wherein the elongated member is made of a material that is transparent to x-rays.

19. The sheath of claim 16, wherein the elongated member includes at least one radiopaque marker.

20. The sheath of claim 16, wherein the medical device is a guidewire.

21. The sheath of claim 16, wherein the medical device is a catheter.

22. The sheath of claim 16, wherein the clip is configured to directly engage the medical device when the medical device is in its second position.

23. A sheath for maintaining patency of an opening in a human or animal body, the sheath comprising:

an elongated member configured to maintain the patency of an opening in the human or animal body, the elongated member defining a proximal end portion, a distal end portion, and a lumen extending from the proximal end portion to the distal end portion, the lumen being configured to receive at least a portion of a medical device such that the medical device may be moved from a first position where the medical device passes through a portion of the lumen defined by the proximal end portion of the elongated member to a second position, the elongated member including a band disposed over a portion of a slot defined by the proximal end portion of the elongated member, the slot being in communication with the lumen, the band being configured to engage the medical device when the medical device is in the second position and a portion of the medical device is passed through the slot to restrict longitudinal motion of the medical device with respect to the elongated member.

24. The sheath of claim 23, wherein the elongated member is made of a material that is transparent to visible light.

25. The sheath of claim 23, wherein the elongated member is made of a material that is transparent to x-rays.

26. The sheath of claim 23, wherein the elongated member includes at least one radiopaque marker.

27. The sheath of claim 23, wherein the band is configured to directly engage the medical device when the medical device is in the second position.

28. A sheath for maintaining patency of an opening in a human or animal body, comprising:

an elongated hollow member having sufficient rigidity to maintain patency of the opening of the body, the elongated hollow member including a transparent material that permits imaging through the wall of the elongated hollow member, the transparent material being transparent to visible light, the elongated hollow member having a proximal end portion, a distal end portion, and a radiopaque marking, the proximal end portion including a proximal end face, the elongated hollow member allowing movement of a medical device from a first position where the medical device passes through the proximal end face to a second position where longitudinal motion of the medical device is restricted, the elongated hollow member defining a retaining slot to engage the medical device when in the second position to restrict longitudinal motion of the medical device, the elongated hollow member including a clip disposed at least partially adjacent the slot, the clip configured to engage the medical device when in the second position, the elongated hollow member including a magnet disposed adjacent to the slot.

29. The sheath of claim 28, wherein the slot provides an interference fit with the medical device to restrict longitudinal motion of the medical device with respect to the elongated member.

30. The sheath of claim 28, wherein the radiopaque marking is a radiopaque line disposed on and parallel to a length of the elongated hollow member.

31. The sheath of claim 28, further comprising:

a plurality of radiopaque markings.

32. The sheath of claim 28, wherein the elongated hollow member is configured to be viewed with an imaging device to view objects disposed within or adjacent to the elongated hollow member.

33. The sheath of claim 28, wherein the elongated hollow member is configured to be viewed with an imaging device to view objects disposed within or adjacent to the elongated hollow member, the imaging device being a side-viewing endoscope.

34. The sheath of claim 28, wherein the elongated hollow member is configured to be viewed with an imaging device to view objects disposed within or adjacent to the elongated hollow member, the imaging device being a fluoroscopic imaging system external to the body.

35. The sheath of claim 28, wherein the radiopaque marking is disposed at a distal end of the elongated hollow member.

36. The sheath of claim 28, wherein the radiopaque marking is disposed at a distal end of the elongated hollow member, the elongated hollow member is configured to be viewed with an imaging device to view objects with respect to the radiopaque marking.

37. The sheath of claim 28, wherein the transparent material is transparent to x-rays.

38. The sheath of claim 28, wherein at least one of the clip or the magnet is configured to directly engage the medical device when the medical device is in the second position.

39. A sheath for maintaining patency of an opening in a human or animal body, comprising:

an elongated hollow member having sufficient rigidity to maintain patency of the opening of the body, the elongated hollow member including a transparent material that permits imaging through the wall of the elongated hollow member, the transparent material being transparent to visible light, the elongated hollow member having a proximal end portion, a distal end portion, and a radiopaque marking, the proximal end portion including a proximal end face, the elongated hollow member allowing movement of a medical device from a first position where the medical device passes through the proximal end face to a second position where longitudinal motion of the medical device is restricted, the elongated hollow member comprising a band to engage the medical device when in the second position and when a portion of the medical device is passed through a slot defined by the proximal end portion of the elongated hollow member to restrict longitudinal motion of the medical device, the band being disposed over a portion of the slot, the slot being in communication with a lumen defined by the elongated hollow member.

40. The sheath of claim 39, further comprising:

a plurality of radiopaque markings.

41. The sheath of claim 39, wherein the transparent material is transparent to x-rays.

42. The sheath of claim 39, wherein the band is configured to directly engage the medical device when the medical device is in the second position.