IP Library Granted Patent US 9,358,038
Granted Patent B2
US 9,358,038 · App. 14/322,015 · Granted Jun 7, 2016

Spinal canal access and probe positioning, devices and methods

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Quick Facts
Patent No.
US 9,358,038
App. No.
14/322,015
Granted
Jun 7, 2016
Kind
B2
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 (42)

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:

the housing including a main fluid passage and a chamber in parallel with and connected to a portion of the main fluid passage by a proximal port and a distal port;

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, wherein the pressure sensor is in communication with the chamber; 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 the 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 1 , further comprising detecting a decrease in detected pressure as indication of entry into the epidural space.

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

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

9. The method of claim 5 , further comprising aspirating the probe or a positioned catheter for determining presence or absence of CSF or blood fluid.

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

11. The method of claim 10 , comprising detecting an increase in pressure as an indication of entry into the CSF space.

12. The method of claim 10 , comprising detecting a pressure waveform indicating positioning of the probe in the CSF space.

13. The method of claim 10 , further comprising flowing fluid into the probe, device or coupled syringe for CSF fluid collection or further indication of probe positioning.

14. The method of claim 10 , further comprising monitoring pressure of the CSF during a fluid collection.

15. The method of claim 14 , further comprising discontinuing fluid collection in response to detected pressure readings.

16. The method of claim 10 , further comprising detecting CSF pressure indicative of a pathological condition.

17. 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, the housing including a main fluid passage and a chamber in parallel with and connected to a portion of the main fluid passage by a proximal port and a distal port;

a pressure sensing system at least partially carded 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, wherein the pressure sensor is in communication with the chamber; 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.

18. The device of claim 17 , 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.

19. The device of claim 17 , wherein the device is sized for hand-held use by a medical provider.

20. The device of claim 19 , wherein the housing comprising a gripping portion with the display carried by the housing on a side generally opposite the gripping portion.

21. The device of claim 19 , wherein the visual display is angled proximally relative to a long axis of the devices.

22. The device of claim 17 , wherein 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.

23. The device of claim 22 , 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.

24. The device of claim 17 , wherein the probe comprises an epidural needle.

25. The device of claim 17 , wherein the probe comprises a lumbar puncture needle.

26. The device of claim 17 , further comprising a pressure relief or buffer system structured to accommodate non patient-anatomical fluctuations of pressure in the device.

27. The device of claim 26 , wherein the pressure relief or buffer system comprises a reservoir disposed between a pressure tube and a fluid channel; and wherein, the pressure sensing system includes a positive pressure before the probe is inserted into tissue of a patient.

28. The method of claim 5 , further comprising introducing pressure into the device while advancing the probe into the epidural space.

29. The method of claim 28 , further comprising detecting a decrease in detected pressure as indication of entry into the epidural space relative to the initial pressure.

30. The method of claim 1 , further comprising introducing an initial pressure into the device prior to advancing the probe into the tissue of the patient.

31. The method of claim 30 , wherein introducing the initial pressure includes connecting a syringe to the device and activating the syringe to pressurize the device with a fluid.

32. The device of claim 17 , wherein pressure sensing system is configured to receive a fluid from syringe to create a raised positive pressure before introducing the probe into the tissue of the patient.

Assignments (6)
PATENT SECURITY AGREEMENT Recorded May 28, 2026
From: MEDLINE INDUSTRIES, LP
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS NOTES COLLATERAL AGENT
Reel/Frame 075643/0462 →
PATENT SECURITY AGREEMENT Recorded Jun 20, 2025
From: MEDLINE INDUSTRIES, LP
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS NOTES COLLATERAL AGENT
Reel/Frame 071672/0100 →
SECURITY INTEREST Recorded Oct 21, 2021
From: MEDLINE INDUSTRIES, LP
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 057927/0091 →
SECURITY INTEREST Recorded Oct 21, 2021
From: MEDLINE INDUSTRIES, LP
To: BANK OF AMERICA, N.A.
Reel/Frame 058040/0001 →
CHANGE OF NAME Recorded Oct 20, 2021
From: MEDLINE INDUSTRIES, INC.
To: MEDLINE INDUSTRIES, LP
Reel/Frame 057876/0748 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2019
From: CENTURION MEDICAL PRODUCTS COMPANY
To: MEDLINE INDUSTRIES, INC.
Reel/Frame 048032/0072 →