Methods and Apparatuses for Navigating the Subaracnhnoid Space

• US 20090076357A1
• Filed: 11/25/2008
• Published: 03/19/2009
• Est. Priority Date: 07/13/2001
• Status: Active Grant

• Current Assignee: Endophys Holdings, LLC
• Original Assignee: Phillip D. Purdy
• Inventors: Purdy, Phillip D.
• Granted Patent: US 7,787,954 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 subarachnoid 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.

Claims

1. A method of achieving intracranial access from an entry location in spinal subarachnoid space, comprising:

introducing a guidewire into the spinal subarachnoid space;

introducing a device over the guidewire and into the spinal subarachnoid space;

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

introducing a penetration apparatus through the device;

puncturing the pia mater using the penetration apparatus;

advancing an electrode through the device and through the pia mater; and

placing the electrode on or in brain tissue.

2. The method of claim 1, further comprising:

applying electric current to the brain tissue with the electrode.

3. The method of claim 2, where the electrode is linked to a wire through a signal can be sent to the electrode to cause application of the electric current.

4. The method of claim 2, where a signal is wireless sent to the electrode to cause application of the electric current.

5. The method of claim 1, further comprising:

applying heat to the brain tissue with the electrode.

6. The method of claim 5, where the electrode is linked to a wire through a signal can be sent to the electrode to cause application of the heat.

7. The method of claim 5, where a signal is wireless sent to the electrode to cause application of the heat.

8. The method of claim 1, further comprising:

applying cryothermal stimulation to the brain tissue with the electrode.

9. The method of claim 8, where the electrode is linked to a wire through a signal can be sent to the electrode to cause the cryothermal stimulation.

10. The method of claim 8, where a signal is wireless sent to the electrode to cause the cryothermal stimulation.

11. The method of claim 1, where the penetration apparatus includes an outer sleeve element and an inner puncture element, and the outer sleeve element and the inner puncture element are slidably coupled together.

12. The method of claim 11, further comprising:

applying electric current to the brain tissue with the electrode.

13. The method of claim 12, where the electrode is linked to a wire through a signal can be sent to the electrode to cause application of the electric current.

14. The method of claim 12, where a signal is wireless sent to the electrode to cause application of the electric current.

15. The method of claim 11, further comprising:

applying heat to the brain tissue with the electrode.

16. The method of claim 15, where the electrode is linked to a wire through a signal can be sent to the electrode to cause application of the heat.

17. The method of claim 15, where a signal is wireless sent to the electrode to cause application of the heat.

18. The method of claim 11, further comprising:

applying cryothermal stimulation to the brain tissue with the electrode.

19. The method of claim 18, where the electrode is linked to a wire through a signal can be sent to the electrode to cause the cryothermal stimulation.

20. The method of claim 18, where a signal is wireless sent to the electrode to cause the cryothermal stimulation.

21. A method of achieving intracranial access from an entry location in spinal subarachnoid space, comprising:

introducing a guidewire into the spinal subarachnoid space;

introducing a device over the guidewire and into the spinal subarachnoid space;

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

introducing a penetration apparatus through the device;

puncturing the pia mater using the penetration apparatus;

advancing a detector through the device and through the pia mater; and

placing the detector on or in brain tissue.

22. The method of claim 21, where the detector is an electroencephalography electrode and the method further comprises:

monitoring electrical activity using the electroencephalography electrode.

23. The method of claim 21, where the detector is a sensor and the method further comprises:

monitoring a biochemical property using the sensor.

24. The method of claim 23, where the biochemical property comprises pH, glucose concentration, oxygen tension, carbon dioxide concentration, or sodium concentration.

25. The method of claim 21, where the detector is a thermal sensor and the method further comprises:

monitoring temperature using the sensor.

26. The method of claim 21, further comprising:

monitoring neurotransmitter concentration using the detector.

27. The method of claim 21, where the detector includes an anchoring mechanism.

28. A method of achieving intracranial access from an entry location in spinal subarachnoid space, comprising:

introducing a guidewire into the spinal subarachnoid space;

introducing a first device over the guidewire and into the spinal subarachnoid space;

advancing the first device from the spinal subarachnoid space into the intracranial subarachnoid space;

introducing a penetration apparatus through the first device;

puncturing the pia mater using the penetration apparatus;

advancing a second device through the first device and through the pia mater; and

positioning the second device proximate the brain, the ventricular system, or a cranial nerve.

29. A sheath comprising:

a first sheath member having a first passageway, a first length, and a first proximal end defined by a first valve apparatus configured to seal the first passageway, the first passageway having a first passageway diameter at a location in the first passageway; and

a second sheath member coupled to the first sheath member, the second sheath member having a second passageway and a second length, the second passageway having a second passageway diameter at a location in the second passageway;

where the first passageway and the second passageway are separate from each other and not co-axial, the first length is different from the second length, and the first and second sheath members are positioned beside each other for a portion of their first and second lengths.

30. The sheath of claim 29, where the first passageway diameter is different from the second passageway diameter.

31. The sheath of claim 29, where the first passageway diameter is the same as the second passageway diameter.

32. The sheath of claim 29, where the first length is greater than the second length, and the first passageway diameter is greater than the second passageway diameter.

33. The sheath of claim 29, where the first length is greater than the second length, and the second passageway diameter is greater than the first passageway diameter.

34. The sheath of claim 29, where the first sheath member has a first cross-sectional outer profile, the second sheath member has a second cross-sectional outer profile, and the first sheath member is coupled to the second sheath member with a coupling device that has a third cross-sectional outer profile that is different from both the first and second cross-sectional outer profiles.