Introducer sheath

• US 7,011,647 B2
• Filed: 12/23/2002
• Issued: 03/14/2006
• Est. Priority Date: 07/13/2001
• Status: Expired due to Fees

• Current Assignee: Endophys Holdings, LLC, Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation), Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Eder, Joseph C., Bashiri, Mehran, Purdy, Phillip D., Ramzipoor, Kamal, Pham, Pete Phong, Nair, Ajit
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/328,349
• Publication Number:
  US 20030130577A1
• Time in Patent Office: 1,177 Days
• Field of Search: 604/95.03, 604/96.01, 604/158, 604/161, 604/164.01, 604/164.02, 604/164.03, 604/164.04, 604/164.07, 604/164.1, 604/174, 604/264, 604/523, 604/524, 604/525, 606/191, 606/192, 606/194
• US Class Current: 604/164.04
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

A variety of devices for use in accessing the subarachnoid space are described. In several embodiments an introducer sheath is disclosed having three main sections, a distal portion, an intermediate portion, and a proximal portion. The distal portion and intermediate portion form a first bend, and the intermediate portion and the proximal portion form a second bend, giving the overall device a general L-shape, S-shape, C-shape, or a three dimensional Z-shape. Apparatuses for attaching an introducer sheath to the skin of a patient are also discussed, as are methods for using, shaping and sizing an introducer sheath.

Claims

1. An introducer sheath including an elongate shaft having a proximal end and a distal end comprising:

a first section at the distal end of the elongate shaft;

a second section proximate the first section;

a third section proximate the second section;

wherein the first section and the second section are predisposed at a first angle, and the second section and the third section are predisposed at a second angle;

an attachment apparatus coupled to the elongate shall adjacent the second angle;

wherein the first section, the second section, and the third section include a lumen passing therethrough; and

wherein the first section is adapted for introduction into a spinal subarachnoid space and the first angle, and intermediate section, are adapted for passage through an interspace.

2. The introducer sheath according to claim 1, wherein the second section provides a S-shaped intermediation between the first section and the third section.

3. The introducer sheath according to claim 2, wherein the first section is of a lesser stiffness than the second section and the third section.

4. The introducer sheath according to claim 1, wherein the first angle may be adjusted by warming the material of area of the introducer sheath corresponding to the first angle to a temperature above room temperature.

5. The introducer sheath according to claim 1, wherein the second section has a length in the range of 2–

12 centimeters.

6. The introducer sheath according to claim 5, wherein the second section has a length in the range of 5–

7 centimeters.

7. The introducer sheath according to claim 1, wherein the first section has a length in the range of 1 and 75 centimeters.

8. The introducer sheath according to claim 7, wherein the first section has a length in the range of 25 and 50 centimeters.

9. The introducer sheath according to claim 1, wherein the third section has a length of at least 5 centimeters.

10. The introducer sheath according to claim 9, wherein the third section has a length of 30 centimeters or less.

11. The introducer sheath of claim 1, wherein the second section has a length that is adapted to separate the first section and the third section such that when the first section is inserted into a subarachnoid space of a patient, at least part of the third section is disposed adjacent the skin of the patient.

12. The introducer sheath according to claim 1, wherein the third section includes a non-return valve.

13. The introducer sheath according to claim 12, wherein the non-return valve is a Leur valve, a hemostatic valve, an injection membrane, or an injection port.

14. The introducer sheath according to claim 1, wherein the first and second sections are adapted for entry into the subarachnoid space of a vertebrate organism.

15. The introducer sheath according to claim 1, wherein the first angle is effected across a length in the range of 0.5–

7 centimeters of the first section.

16. The introducer sheath according to claim 15, wherein the first angle is effected across a length in the range of 3–

5 centimeters of the first section.

17. The introducer sheath according to claim 1, wherein the first angle is effected across a length of the first section that is more flexible than the rest of the first section.

18. The introducer sheath according to claim 1, wherein the first angle is effected across a length of the first section that is softer than the rest of the first section.

19. The introducer sheath according to claim 1, wherein the second angle is effected across a length in the range of 0.5–

7 centimeters of the second section.

20. The introducer sheath according to claim 19, wherein the second angle is effected across a length in the range of 3–

5 centimeters of the second section.

21. The introducer sheath according to claim 1, wherein the second angle is effected across a length of the second section that is softer than the rest of the second section.

22. The introducer sheath according to claim 1, wherein the second angle is effected across a length of the second section that is more flexible than the rest of the second section.

23. The introducer sheath of claim 1, wherein a portion of the lumen extending trough the first section has an inner diameter in the range of about 0.1–

3 millimeters.

24. The introducer sheath of claim 1, wherein the first section has an outer diameter in the range of 0.2–

4 millimeters.

25. The introducer sheath of claim 24, wherein the first section has an outer diameter in the range of 1–

4 millimeters.

26. The introducer sheath of claim 1, wherein the attachment apparatus includes a suture location for attaching the attachment apparatus to a patient'"'"'s skin with a suture.

27. The introducer sheath of claim 1, wherein the attachment apparatus includes an adhesive layer for adhering the attachment apparatus to a patient'"'"'s skin.

28. The introducer sheath of claim 1, wherein the attachment apparatus defines an attachment lumen through which the third section passes.

29. The introducer sheath of claim 28, wherein the attachment lumen rums in a longitudinal direction of the attachment apparatus, the length of the attachment apparatus is in the range of up to 50 centimeters, the width of the attachment apparatus is in the range of up to 50 centimeters, and the height of the attachment apparatus is in the range of 2–

50 millimeters.

30. The introducer sheath of claim 1, wherein the attachment apparatus is adapted to allow the third section to divide into a multi-member segment.

31. The introducer sheath of claim 1, wherein the attachment apparatus includes two or more separate devices each including an attachment mechanism for attachment to the skin of a patient.

32. The introducer sheath of claim 1, wherein the attachment apparatus includes a gap adapted to decrease discomfort caused to a patient by the attachment apparatus.

33. The introducer sheath of claim 1, wherein the attachment apparatus includes a foam pad adapted to decrease discomfort caused to a patient by the attachment apparatus.

34. The introducer sheath of claim 1, further including a fourth section for attaching to the proximal end of the third section, the third section and the fourth section forming a joint therebetween.

35. The introducer sheath of claim 1, wherein the first angle is in the range of 60–

180 degrees.

36. The introducer sheath of claim 35, wherein the first angle is in the range of 125–

145 degrees.

37. The introducer sheath of claim 1, wherein the second angle is in the range of 30–

170 degrees.

38. The introducer sheath of claim 37, wherein the second angle is in the range of 120–

150 degrees.

39. The introducer sheath of claim 1, wherein the first section and at least 5 centimeters of the third section lie in planes parallel to the coronal plane of a patient into whom the introducer sheath has been inserted.

40. The introducer sheath of claim 1, wherein the sheath is adapted so that, once introduced into a patient, the first section extends from a chosen entry location for the patient towards the patient'"'"'s head.

41. The introducer sheath of claim 1, wherein the third section is of a sufficient length to allow a physician to access the proximal end of the introducer sheath while the first section is disposed within the spinal subarachnoid space of a patient while the patient is being imaged in a magnetic resonance imaging system.

42. The introducer sheath of claim 1, wherein the third section includes more than one non-return valve.

43. The introducer sheath of claim 1, wherein the first section includes a coating detectable by a magnetic resonance imaging system.

44. The introducer sheath of claim 43, wherein the coating includes extracellular gadolinium.

45. The introducer sheath of claim 43, wherein the coating includes dysprosium.

46. The introducer sheath of claim 1, wherein the first section is more flexible than the second section.

47. The introducer sheath of claim 1, wherein the distal end of the first section is more flexible than a less-distal portion of the first section.

48. The introducer sheath of claim 1, wherein at least a portion of the elongate shaft is resistant to kinking.

49. The introducer sheath of claim 48, wherein the elongate shaft includes a kink-resistant support member extending for a portion of the elongate shaft.

50. The introducer sheath of claim 1, wherein the distal end of the first section is softer than a less-distal portion of the first section.

51. The introducer sheath of claim 1, wherein the distal end of the first section is softer than at least a portion of the first section, second section, and third section.

52. The introducer sheath of claim 1, wherein the distal end includes an atraumatic tip.

53. The introducer sheath of claim 1, wherein the first section includes at least one temperature sensor for sensing the temperature of an area of the subarachnoid space.

54. The introducer sheath of claim 1, wherein the first section includes at least one pressure sensor for sensing the pressure within an area of the subarachnoid space.

55. The introducer sheath of claim 1, wherein the elongate shaft is adapted to be detectable using X-ray visualization techniques.

56. The introducer sheath of claim 1, wherein at least a portion of the elongate shaft includes a hydrophilic outer surface.

57. The introducer sheath of claim 56, wherein the hydrophilic outer surface is effected by providing a hydrophilic coating over a portion of the elongate shaft.

58. An introducer sheath comprising:

an elongated tubular member;

means for allowing the elongated tubular member to include a first section that is adapted to be disposed in a spinal subarachnoid space of a person, a second section adapted to be disposed in an interspace of a person, a third section adapted to extend externally from the person, the second section and the third section predisposed at an angle, and an attachment apparatus coupled elongated tubular member adjacent the angle.

59. An introducer sheath for use in percutaneous interspinal navigation into a subarachnoid space of a vertebrate organism, the introducer sheath comprising:

an elongated shaft having a proximal end and a distal end, the shaft including a first section at the distal end and a second section proximal to the first section;

the first section and the second section preformed at an angle similar to the angle defined by an interspace between two vertebrae of the organism and the a spinal subarachnoid space of the organism;

a third section coupled to the second section, the third section being preformed at an angle relative to the second section and disposed proximally of the second section; and

an attachment apparatus attached to the shall adjacent to the angle between the second section and the third section.

60. The introducer sheath of claim 59, wherein the first section is adapted and configured for insertion into a spinal subarachnoid space of the organism, and the second section is adapted end configured for insertion into the interspace between two vertebrae of the organism.

61. The introducer sheath of claim 59, wherein the length of the second section is defined by the distance between the spinal subarachnoid space and the skin of the organism.

62. The introducer sheath of claim 59, wherein the angle between the second section and the third section is similar to the angle defined by the interspace between two vertebrae of the organism and the surface of the skin on the back of the organism.