Introducer sheath

• US 20030130577A1
• Filed: 12/23/2002
• Published: 07/10/2003
• Est. Priority Date: 07/13/2001
• Status: Active Grant

• Current Assignee: Endophys Holdings, LLC, Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Eder, Joseph C., Bashiri, Mehran, Nair, Ajit, Purdy, Phillip D., Ramzipoor, Kamal, Pham, Pete Phong
• Granted Patent: US 7,011,647 B2
• Time in Patent Office: Days
• US Class Current: 600/433
• 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
• 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 at a first angle, and the second section and the third section are at a 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 at least 30 centimeters.

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 through 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, further including an attachment apparatus coupled to the third section.

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

28. The introducer sheath of claim 26, wherein the attachment apparatus includes an adhesive layer for adhering the attachment apparatus to a patient'"'"'s skin.

29. The introducer sheath of claim 26, wherein the attachment apparatus defines an attachment lumen through which the third section passes.

30. The introducer sheath of claim 29, wherein the attachment lumen runs 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.

31. The introducer sheath of claim 26, wherein the attachment apparatus is adapted to allow the third section to divide into a multi-member segment.

32. The introducer sheath of claim 26, wherein the attachment apparatus includes two or more separate devices each including an attachment mechanism for attachment to the skin of a patient.

33. The introducer sheath of claim 26, wherein the attachment apparatus includes a gap adapted to decrease discomfort caused to a patient by the attachment apparatus.

34. The introducer sheath of claim 26, wherein the attachment apparatus includes a foam pad adapted to decrease discomfort caused to a patient by the attachment apparatus.

35. 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.

36. The introducer sheath of claim 1, wherein the first angle is in the range of 60-180 degrees.

37. The introducer sheath of claim 36, wherein the first angle is in the range of 125-145 degrees.

38. The introducer sheath of claim 1, wherein the second angle is in the range of 30-170 degrees.

39. The introducer sheath of claim 38, wherein the second angle is in the range of 120-150 degrees.

40. 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.

41. 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.

42. 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.

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

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

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

46. The introducer sheath of claim 44, wherein the coating includes dysprosium.

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

48. 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.

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

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

51. 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.

52. 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.

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

54. 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.

55. 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.

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

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

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

59. A method of accessing the subarachnoid space comprising:

providing an introducer sheath having a first section connected by a second section to a third section and an introducer lumen extending therethrough, the first section and the second section forming a first angle, the second section and the third section forming a second angle, the introducer lumen being adapted to allow a medical device to slide therethrough; and

percutaneously introducing the introducer sheath into the spinal subarachnoid space at an entry location, the introducer sheath once introduced into a patient having at least a portion of the first section disposed inside the spinal subarachnoid space and at least a portion of the third section external to the patient.

60. The method of claim 59, wherein the step of percutaneously introducing the introducer sheath includes the step of piercing the dural membrane of the spinal subarachnoid space with a needle.

61. The method of claim 60, wherein the step of percutaneously introducing the introducer sheath further includes the step of advancing a guidewire through the needle into the subarachnoid space and advancing the introduce sheath over the guidewire.

62. The method of claim 59, further including the step of advancing a first device via the introducing lumen of the introducer sheath into the subarachnoid space.

63. The method of claim 62, further including the steps of:

removing the first device from the subarachnoid space; and

advancing a second device via the introducing lumen into the subarachnoid space.

64. The method of claim 59, further including the step of shaping the introducer sheath to match the anatomical contours of the patient prior to the step of percutaneously introducing the introducer sheath into the spinal subarachnoid space.

65. The method of claim 64, further including the step of treating the introducer sheath to cause the material used in making the introducer sheath to become temporarily more flexible.

66. The method of claim 65, wherein the step of treating the introducer sheath includes applying heat to a portion of the introducer sheath.

67. The method of claim 59, further including the step of securing the introducer sheath to the skin of the patient.

68. The method of claim 67, wherein the step of securing the introducer sheath includes suturing an attachment device to the skin of the patient.

69. The method of claim 67, wherein the step of securing the introducer sheath includes pressing an attachment device having an adhesive area to the skin of the patient.

70. The method of claim 59, wherein the first section, once introduced into the spinal subarachnoid space, extends from the entry location towards the patient'"'"'s head.

71. The method of claim 59, wherein the first section, once introduced into the spinal subarachnoid space, extends from the entry location away from the patient'"'"'s head.

72. The method of claim 59, further including the step of shaping the introducer sheath to match the anatomy of the patient during the step of percutaneously introducing the introducer sheath into the spinal subarachnoid space.

73. The method of claim 59, wherein, after insertion of the introducer sheath, the first section and at least five centimeters of the third section lie in planes parallel to the coronal plane of a patient into whom the introducer sheath has been inserted.

74. The method of claim 59, wherein, after insertion of the introducer sheath, the second section forms an angle of between about 55 to 125 degrees with respect to the coronal plane of the patient along a transverse plane of the patient.

75. The method of claim 74, wherein, after insertion of the introducer sheath, the second section forms an angle of between about 70 and 110 degrees with respect to the coronal plane of the patient along a transverse plane of the patient.

78. The method of claim 73, wherein the step of selecting an interspace of the patient includes:

determining the size of the lumen required for performing a medical procedure that utilizes the lumen; and

determining the size of an interspace required to pass an introducer sheath having a lumen of the required size.

76. A method of performing a medical operation on a patient, the method including:

selecting an interspace of the patient;

providing an introducer sheath having a distal end, a proximal end, and a lumen therethrough, the distal end adapted for introduction through the interspace; and

advancing the distal end through the interspace into the spinal subarachnoid space of the patient.

77. The method of claim 76, further including the step of:

advancing the introducer sheath into the spinal subarachnoid space until the distal tip of the first section is adjacent the pia mater.

79. The method of claim 76, wherein the introducer sheath includes a preformed shape, the method further including the step of modifying the preformed shape adapt the introducer sheath to the characteristics of the selected interspace.

80. 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, and a third section adapted to extend externally from the person.

81. An attachment apparatus for attaching a spinal introducer sheath to a patient, the apparatus comprising:

a body member;

a means for attaching the body member to the back of a patient;

a means for attaching the spinal introducer sheath to the body member.

82. 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 forming 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.

83. The introducer sheath of claim 82, wherein the first section is adapted and configured for insertion into a spinal subarachnoid space of the organism, and the second section is adapted and configured for insertion into the interspace between two vertebrae of the organism.

84. The introducer sheath of claim 82, wherein the length of the second section is defined by the distance between the spinal subarachnoid space and the skin of the organism.

85. The introducer sheath of claim 82, further including a third section proximal to the second section, the second section and the third section forming an angle 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.

86. A medical device comprising:

an elongate member having a proximal end and a distal end, the distal end sized for insertion into a spinal subarachnoid space via an interspace; and

a transducer disposed on the elongate member near the distal end.

87. The medical device of claim 86, wherein the transducer is a pressure sensor.

88. The medical device of claim 86, wherein the transducer is a temperature sensor.

89. The medical device of claim 86, wherein the transducer is adapted for wirelessly communicating a chemical or biometric property while disposed in the spinal subarachnoid space.

90. The medical device of claim 86, further comprising communication means coupled to the transducer.

91. The medical device of claim 90, wherein the communication means is embedded into a portion of a wall of the elongate member.

92. A method of measuring a biometric property within a subarachnoid space, the method comprising:

providing an elongate member having a proximal end and a distal end;

attaching a transducer to the elongate member near the distal end;

inserting the distal end of the elongate member into a spinal subarachnoid space through an interspace between two vertebrae;

advancing the distal end of the elongate member within the spinal subarachnoid space until the transducer is disposed within the spinal subarachnoid space; and

capturing data related to the biometric property with the transducer.

93. The method of claim 92, wherein the biometric property is CSF pressure.

94. The method of claim 92, wherein the transducer is adapted for wireless communication.

95. The method of claim 92, further comprising:

providing a communication means for communicating with the transducer;

coupling the communication means to the transducer such that, as the transducer is introduced into the spinal subarachnoid space, a part of the communication means enters the spinal subarachnoid space.

96. The method of claim 95, wherein the communication means is a wire.

97. The method of claim 96, wherein the wire is embedded into the elongate member.

98. The method of claim 92, further comprising advancing the elongate member through the spinal subarachnoid space and into the intracranial space until the transducer is within one of the lateral ventricles.

99. The method of claim 92, further comprising advancing the elongate member through the spinal subarachnoid space and into the intracranial space until the transducer is within the third ventricle.

100. The method of claim 92, further comprising advancing the elongate member through the spinal subarachnoid space and into the intracranial space until the transducer is within the fourth ventricle.

101. A method of monitoring a physiological condition, the method comprising:

providing an elongate medical device having a proximal end and a distal end, the elongate medical device adapted to enter the subarachnoid space; and

providing a transducer on the distal end of the elongate medical device.

102. The method of claim 101, wherein the elongate medical device is adapted for entry to the spinal subarachnoid space via a burr-hole.

103. The method of claim 101, wherein the elongate medical device is adapted for entry to the subarachnoid space through the intraspinal subarachnoid space.

104. The method of claim 101, wherein the elongate medical device is adapted for entry directly into the intracranial subarachnoid space.

105. A method of performing a ventriculostomy, the method comprising:

providing a medical device having a proximal end and a distal end, the medical device being adapted for entry to the subarachnoid space;

providing a pressure transducer on a distal portion of the medical device;

inserting the distal end of the medical device into the subarachnoid space such that the pressure transducer is disposed at a location to allow for measurement of local pressure in an area of the subarachnoid space.