Methods and apparatuses for navigating the subarachnoid space

• US 7,455,666 B2
• Filed: 07/13/2001
• Issued: 11/25/2008
• Est. Priority Date: 07/13/2001
• Status: Expired due to Fees

• Current Assignee: Endophys Holdings, LLC
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Purdy, Phillip D.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): MOULTON, ELIZABETH ROSE
• Application Number:
  US09/905,670
• Publication Number:
  US 20030014016A1
• Time in Patent Office: 2,692 Days
• Field of Search: 604/500, 604/506, 604/508, 604/510, 604/522, 604/523, 604/93.01, 604/96.01, 604/164.01, 604/164.13, 604/264, 604/272, 128/898
• US Class Current: 604/506
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• 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 2025/091 : having a lumen for drug delivery or suction
• 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 25/09 : Guide wires
• CPC Class Codes: A61M 25/09041 : Mechanisms for insertion of guide wires
• 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
• CPC Class Codes: A61M 39/22 : Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy

Abstract

Disclosed is a method of navigating a spinal subarchnoid space in a living being, that includes percutaneously introducing a device into the spinal subarachnoid space at an entry location. The device has a first passageway that is sized to slidably receive, and work with, at least a guidewire. The device can be a catheter or a sheath. The method can also include advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location. Alternatively, the method can include advancing the device within the spinal subarachnoid space to facilitate intracranial access with a second device introduced through the first passageway. Also disclosed is a device suited for attachment to a patient'"'"'s skin, such as a sheath, that includes an elongated member, a skin-attachment apparatus having a flexible skin-attachment flap, and a valve apparatus. The skin-attachment apparatus and the valve apparatus may be coupled to the elongated member in spaced relation to each other.

Claims

1. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a guidewire in a first direction through an introducer and into the spinal subarachnoid space at an entry location, the guidewire being sufficiently flexible to navigate the spinal subarachnoid space, the introducer having a distal end;

advancing the guidewire in a second direction beyond the distal end of the introducer, the second direction being different from the first direction;

percutaneously introducing a device over the guidewire and into the spinal subarachnoid space, the device having a first passageway sized to slidably receive, and work with, at least the guidewire, and the guidewire being positioned in the first passageway;

advancing the device over the guidewire and within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together;

puncturing the pia matter using the penetration apparatus; and

advancing the device over the guidewire from the spinal subarachnoid space into the intracranial subarachnoid space.

2. The method of claim 1, further comprising:

removing a portion of the brain of the living being.

3. The method of claim 1, wherein the living being contains cerebrospinal fluid, and further comprising:

flushing at least some cerebrospinal fluid in order to remove blood from that cerebrospinal fluid.

4. The method of claim 1, wherein the device includes a second passageway sized to slidably receive, and work with, at least a guidewire.

5. The method of claim 4, further comprising:

introducing an endoscope through the first passageway of the device.

6. The method of claim 4, wherein the device includes a first sub-elongated member that has the first passageway, and a second sub-elongated member coupled to the first sub-elongated member, the second sub-elongated member having the second passageway.

7. The method of claim 6, wherein the device further includes a braiding material wrapped around the first and second sub-elongated members.

8. The method of claim 1, wherein a cross section taken along the device has a shape that is non-circular.

9. The method of claim 1, further comprising:

delivering medication to an intracranial subarachnoid space.

10. The method of claim 1, wherein the device includes a wall to which an electroencephalography electrode is attached.

11. The method of claim 1, wherein the device includes a wall to which a sensor useful for monitoring a biochemical property is attached, and further comprising:

monitoring either pH, glucose concentration, oxygen tension, carbon dioxide concentration, or sodium concentration using the sensor.

12. The method of claim 1, wherein the device includes a wall to which a thermal sensor useful for monitoring temperature is attached, and further comprising:

monitoring temperature using the thermal sensor.

13. The method of claim 1, further comprising:

creating a lesion in the brain of the living being.

14. The method of claim 1, further comprising:

monitoring the position of the device for a period of time using magnetic resonance imaging, fluoroscopy, endoscopy, computed tomography, thermal imaging, sonography, or any combination of these.

15. The method of claim 1, further comprising:

introducing material through the first passageway of the device; and

placing the material proximate a cranial nerve to assist in treating a neurologic condition.

16. The method of claim 1, further comprising:

introducing genetic material through the first passageway of the device; and

placing the genetic material within the living being to assist in treating a neurologic condition.

17. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a guidewire in a direction through an introducer and into the spinal subarachnoid space at an entry location, the guidewire being sufficiently flexible to navigate the spinal subarachnoid space, the introducer having a distal end;

advancing the guidewire in another direction beyond the distal end of the introducer;

percutaneously introducing a device over the guidewire and into the spinal subarachnoid space, the device having a first passageway sized to slidably receive, and work with, at least the guidewire, and the guidewire being positioned in the first passageway;

advancing the device over the guidewire and within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together;

puncturing the pia matter using the penetration apparatus;

accessing at least one ventricle located within the head with a second device introduced through the first passageway of the device; and

inducing hypothermia in at least some brain tissue.

18. The method of claim 17, further comprising:

draining at least one ventricle located within the head.

19. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a guidewire in a first direction through an introducer and into the spinal subarachnoid space at an entry location, the guidewire being sufficiently flexible to navigate the spinal subarachnoid space, the introducer having a distal end;

advancing the guidewire in a second direction beyond the distal end of the introducer, the second direction being different from the first direction;

percutaneously introducing a device over the guidewire and into the spinal subarachnoid space, the device having a first passageway sized to slidably receive, and work with, at least the guidewire, and the guidewire being positioned in the first passageway;

advancing the device over the guidewire and within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together; and

puncturing the pia matter using the penetration apparatus.

20. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a guidewire into the spinal subarachnoid space at an entry location, the guidewire being sufficiently flexible to navigate the spinal subarachnoid space;

percutaneously introducing a device over the guidewire and into the spinal subarachnoid space, the device having a first passageway sized to slidably receive, and work with, at least the guidewire, and the guidewire being positioned in the first passageway; and

advancing the device over the guidewire and within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

wherein the advancing is achieved via a robotic device.

21. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a device into the spinal subarachnoid space at an entry location, the device having a first passageway sized to slidably receive, and work with, at least a guidewire;

advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together; and

puncturing the pia matter using the penetration apparatus.

22. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a device into the spinal subarachnoid space at an entry location, the device having a first passageway sized to slidably receive, and work with, at least a guidewire; and

advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location using a robotic device.

23. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a device into the spinal subarachnoid space at an entry location, the device having a first passageway sized to slidably receive, and work with, at least a guidewire;

advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together;

puncturing the pia matter using the penetration apparatus;

advancing the device over the guidewire from the spinal subarachnoid space into the intracranial subarachnoid space;

introducing an electroencephalography electrode through the first passageway of the device; and

placing the electrode on or in brain tissue.

24. A method of navigating a spinal subarachnoid space in a living being, comprising:

percutaneously introducing a device into the spinal subarachnoid space at an entry location, the device having a first passageway sized to slidably receive, and work with, at least a guidewire;

advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location;

introducing a penetration apparatus through the first passageway of the device, the penetration apparatus including an outer sleeve element and an inner puncture element, the outer sleeve element and the inner puncture element being slidably coupled together;

puncturing the pia matter using the penetration apparatus; and

accessing at least one ventricle located within the head with a second device introduced through the first passageway of the device.

25. The method of claim 24, further comprising:

draining at least one ventricle located within the head.