Vascular access methods and devices

• US 20110046477A1
• Filed: 08/19/2010
• Published: 02/24/2011
• 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 10,463,838 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• 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 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

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 target tissue; detecting a change in pressure about the distal portion of the coupled probe during advancing, where the detected pressure change indicates probe positioning in a vein or artery of the patient; 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 a target vein of the patient;

detecting a change in pressure about the distal portion of the coupled probe during advancing so as to indicate probe positioning in a vein or an artery of the patient, 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, wherein advancing comprises inserting a distal portion of the probe into a vein of the patient.

5. The method of claim 4, wherein the vein is an internal jugular vein, subclavian vein, or femoral vein.

6. The method of claim 4, detecting an increase in pressure upon probe entry into the vein and discontinuing advancement.

7. The method of claim 4, detecting an increase of pressure indicating that the probe has entered an artery, and altering device advancement based on the detected pressure.

8. The method of claim 4, drawing blood toward a syringe coupled to the proximal portion of the housing for blood visualization.

9. The method of claim 4, introducing a guidewire into the patient'"'"'s vein following confirmation of probe positioning.

10. The method of claim 9, introducing a catheter over the guidewire and into the patient'"'"'s vein.

11. The method of claim 1, the device further comprising a guidewire port carried by the housing and fluidly coupled to the distal portion coupled probe.

12. The method of claim 11, introducing a guidewire through the guidewire port of the device and into the patient'"'"'s vein through the coupled probe.

13. The method of claim 12, detecting a pressure about the distal portion of the probe with the guidewire positioned in the patient'"'"'s vein.

14. A device for detecting positioning of a coupled probe in a vein or artery of a patient, the device comprising:

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

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;

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 vein or artery of the patient; and

a guidewire port carried by the housing and fluidly coupled to the first port.

15. The device of claim 14, 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 about a channel.

16. The device of claim 15, 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.

17. The device of claim 16, wherein the channel is at least partially translucent exteriorly to the device so as to allow visualization of fluid within the channel.

18. The device of claim 17, wherein the guidewire port is fluidly coupled to the channel.

19. The device of claim 17, wherein the pressure sensing unit is in operable communication with the channel.

20. The device of claim 14, wherein the probe comprises a needle.

21. The device of claim 14, wherein the visual display is angled proximally as carried by the housing.

22. The device of claim 14, the reporting signal output via the display comprising at least two different readings indicative of average pressures each measured over a time period having different length of time, frequency of pressure reading, or both.

23. The device of claim 14, the reporting signal output via the display comprising a numerical pressure reading and a non-numerical pressure reading.

24. The device of claim 14, the non-numerical pressure reading comprising bar graph image.

25. An assembly for detecting positioning of a coupled probe in a vein or artery of a patient, the assembly comprising:

a device comprising a housing having a distal portion with a first port that is detachably coupled to a probe and a proximal portion with a second port detachably coupled to a syringe;

a pressure sensing system 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;

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 vein or artery of the patient;

wherein the pressure sensing system and the output unit are disposed substantially between the distal and proximal portions of the housing.