Spinal canal access and probe positioning, devices and methods

• US 20110054353A1
• Filed: 08/19/2010
• Published: 03/03/2011
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Mirador Biomedical Inc.
• Inventors: Swartz, Douglas, Hulvershorn, Justin, Schmidt, Karl
• Granted Patent: US 8,814,807 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• 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 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

Methods and devices for detecting positioning of a probe in a tissue of a patient. A method can include providing a detection device; advancing a device coupled probe through the tissue of the patient and toward the patient'"'"'s spinal canal; detecting a change in pressure about the distal portion of the coupled probe during advancing, where the detected pressure change indicates probe positioning in the patient'"'"'s spinal canal; outputting the detected pressure change or indication of probe positioning to a visual display.

Claims

1. A method for detecting positioning of a probe in a tissue of a patient, comprising:

providing a device comprising a housing having a proximal portion and a distal portion coupled to a probe, the device further comprising;

a pressure sensing system at least partially carried by the housing and comprising a processing unit coupled with a pressure sensor so as to receive signal from the pressure sensor and determine from the received signal a pressure value of an environment about a distal portion of the coupled probe; and

an output unit carried by the housing and comprising a visual display, the output unit coupled to the pressure sensing system so as to receive pressure value signal and output to the visual display a reporting signal indicating the determined pressure value and/or positioning of the probe in the tissue of the patient;

advancing the device distally such that a distal portion of a probe advances through the tissue of the patient and toward the patient'"'"'s spinal canal;

detecting a change in pressure about the distal portion of the coupled probe during advancing indicating probe positioning in the patient'"'"'s spinal canal, and outputting corresponding reporting signal to the visual display.

2. The method of claim 1, wherein the probe is rigidly coupled to the device so as to allow positioning of probe by position manipulation of the device housing by a user.

3. The method of claim 1, wherein the probe is directly coupled to the device.

4. The method of claim 1, comprising coupling probe to the distal portion of the device following insertion of the probe into ligament tissue in the patient'"'"'s back tissue.

5. The method of claim 1, wherein advancing the device comprises entering the probe into epidural space of the patient'"'"'s spinal canal.

6. The method of claim 5, further comprising introducing pressure into the device prior to and/or while advancing the probe into the epidural space.

7. The method of claim 6, detecting a decrease in detected pressure as indication of entry into the epidural space.

8. The method of claim 5, detecting a pressure waveform indicating positioning of the probe in the epidural space.

9. The method of claim 5, introducing an epidural catheter through the probe following detection of entry into the epidural space.

10. The method of claim 5, aspirating the probe or a positioned catheter for determining presence or absence of CSF or blood fluid. This is confusing to me b/c claim 5 only refers to a probe. How does the positioned catheter fit in?

11. The method of claim 1, wherein advancing the device comprises advancing the probe through dura and entering into the subarachnoid space.

12. The method of claim 11, comprising detecting an increase in pressure as an indication of entry into the CSF space.

13. The method of claim 11, comprising detecting a pressure waveform indicating positioning of the probe in the CSF space.

14. The method of claim 11, further comprising flowing fluid into the probe, device or coupled syringe for CSF fluid collection or further indication of probe positioning.

15. The method of claim 11, further comprising monitoring pressure of the CSF during a fluid collection.

16. The method of claim 15, further comprising discontinuing fluid collection in response to detected pressure readings.

17. The method of claim 11, detecting CSF pressure indicative of a pathological condition.

18. A device for detecting positioning of a coupled probe in a spinal canal of a patient, the device comprising:

a housing having a distal portion with a first port that is detachably couplable to a probe, and a proximal portion;

a pressure sensing system at least partially carried by the housing and comprising a processing unit coupled with a pressure sensor so as to receive signal from the pressure sensor and determine from the received signal a pressure value of an environment about a distal portion of the coupled probe; and

an output unit carried by the housing and comprising a visual display, the output unit coupled to the pressure sensing system so as to receive pressure value signal and output to the visual display a reporting signal indicating the determined pressure value and/or positioning of the probe in a spinal canal of the patient,

wherein the pressure sensing system, processor, and output unit are disposed substantially between the first port and the proximal portion of the housing.

19. The device of claim 18, further comprising a memory having instructions that when executed cause the processor to determine a change in pressure indicative of i) entry into epidural space;

ii) entry into CSF space;

iii) a pressure waveform characteristic of a patient'"'"'s spinal canal;

or iv) a combination thereof.

20. The device of claim 18, wherein the device is sized for hand-held use by a medical provider.

21. The device of claim 20, the housing comprising a gripping portion with the display carried by the housing on a side generally opposite the gripping portion.

22. The device of claim 20, wherein the visual display is angled proximally relative to a long axis of the devices.

23. The device of claim 18, the proximal portion of the housing comprising a second port that is detachably couplable to a syringe, and the first port fluidly coupled to the second port.

24. The device of claim 23, further comprising a probe coupled to the first port and a syringe coupled to the second port such that the probe, device, and syringe are arranged axially and in sequence.

25. The device of claim 18, the probe comprising an epidural needle.

26. The device of claim 18, the probe comprising a lumbar puncture needle.

27. The device of claim 18, further comprising a pressure relief or buffer system structured to accommodate non patient-anatomical fluctuations of pressure in the device.

28. The device of claim 27, the pressure relief or buffer system comprising a reservoir disposed between a pressure tube and a fluid channel.