Vascular access methods and devices

• US 10,463,838 B2
• Filed: 08/19/2010
• Issued: 11/05/2019
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Inventors: Hulvershorn, Justin, Schmidt, Karl, Swartz, Douglas
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): Tran, Tho Q
• Application Number:
  US12/806,798
• Publication Number:
  US 20110046477A1
• Time in Patent Office: 3,365 Days
• Field of Search: 600481, 60416801
• 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 of distinguishing between positioning of a probe in a vein or an artery of a patient, comprising:

providing a device comprising a housing having a proximal housing portion and a distal housing portion, the distal housing portion coupled to the 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 a signal from the pressure sensor and determine from the signal a pressure value of an environment about a distal portion of the probe, and

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

advancing the device distally such that the distal portion of the probe advances through tissue of the patient and into the vein of the patient;

detecting a change in pressure about the distal portion of the probe during advancing so as to indicate positioning of the distal portion of the probe;

distinguishing between positioning of the distal portion in the vein of the patient in response to the reporting signal on the visual display;

introducing a guidewire through the housing proximally to distally generally align with the probe into the vein following distinguishing of probe positioning, wherein the guidewire extends out a distal end of the probe; and

drawing blood toward a syringe coupled to the proximal housing portion of the housing for blood visualization.

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;

wherein advancing includes advancing a probe tip of the probe through the tissue of the patient, wherein detecting a change in pressure includes transmitting pressure from the probe tip through a bore in the probe to the pressure sensing system; and

wherein advancing includes positioning the output unit adjacent a patient'"'"'s body during advancing so that the output unit is in a line of sight by the user advancing the device.

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

4. The method of claim 1, wherein the vein is an internal jugular vein, a subclavian vein, or a femoral vein.

5. The method of claim 1, further comprising detecting an increase in pressure upon probe entry into the vein and discontinuing advancement.

6. The method of claim 1, further comprising detecting an increase of pressure indicating that the probe has entered an artery, and altering device advancement based on the detected pressure.

7. The method of claim 1, further comprising withdrawing the probe and the housing while leaving the guidewire and introducing a catheter over the guidewire and into the patient'"'"'s vein.

8. The method of claim 1, the device further comprising a guidewire port carried by the housing, extending to a proximal side of the housing and fluidly coupled to the distal portion coupled probe, and wherein the guidewire port is fluidly sealed proximally to the pressure sensor, further comprising inserting the guidewire through the guidewire port.

9. The method of claim 8, wherein inserting the guidewire through the guidewire port includes introducing the guidewire into the patient'"'"'s vein through the coupled probe while measuring pressure at the distal end of the probe and with a syringe attached to the housing.

10. A device for distinguishing between positioning of a probe in a vein or an artery of a patient, the device comprising:

a housing having a proximal portion and a distal portion, the distal portion having a first port that is detachably couplable to the probe, 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, wherein the channel is at least partially translucent exteriorly to the device so as to allow visualization of fluid within the channel;

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 a signal from the pressure sensor and determine from the signal a pressure value of an environment about a distal portion of the probe;

an output unit carried by the housing intermediate the proximal portion and the distal portion, the output unit comprising a visual display, the output unit coupled to the pressure sensing system so as to receive pressure value signal and provide an output on the visual display comprising a reporting signal indicating at least one of the determined pressure value, a position of the probe in a vein or artery of the patient, or both, wherein the output on the display distinguishes between placement of the distal portion in the artery or the vein; and

a guidewire port carried by the housing and fluidly coupled to the first port wherein the syringe is coupled to the second port such that the probe, device, and syringe are arranged axially and in sequence from the distal portion to the proximal portion.

11. The device of claim 10, wherein the guidewire port is fluidly coupled to the channel with a frangible seal to allow a guidewire therethrough into a patient out a distal end of the probe with the pressure sensing system sensing pressure while inserting the guidewire into the vein without disconnecting the housing from either the probe or the syringe.

12. The device of claim 10, wherein the pressure sensing unit is in operable communication with the channel.

13. The device of claim 10, wherein the probe comprises a needle.

14. The device of claim 10, wherein the visual display is angled proximally within and by the housing and relative to the proximal portion of the housing.

15. The device of claim 10, 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.

16. The device of claim 10, the reporting signal output via the display comprising a numerical pressure reading and a non-numerical pressure reading having a waveform graph.

17. The device of claim 10, wherein the reporting signal output via the display comprises a non-numerical pressure reading comprising bar graph image.

18. An assembly for distinguishing between positioning of a probe in a vein or an 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 the probe and a proximal portion with a second port detachably coupled to a syringe, and a third port to receive a guidewire and connected to the first port to form a path for extending the guidewire through the housing and the probe into a vein;

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 probe; and

an output unit carried by the housing, the output unit comprising a visual display, the output unit coupled to the pressure sensing system so as to receive a pressure value signal and provide an output on the visual display comprising a reporting signal indicating the positioning of the probe in a vein or artery of the patient, wherein the output on the display distinguishes between placement of the distal portion in the artery or the vein, 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;

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

19. The assembly of claim 18, wherein the probe, housing and syringe are assembled substantially in an axial arrangement with the visual display being intermediate the probe and the second port of the housing.

20. The assembly of claim 18, wherein the visual display is intermediate the distal and proximal portions of the housing.

21. The assembly of claim 18, wherein the housing is adapted to be held in a single hand by a user.

22. The assembly of claim 18, wherein the pressure sensing system and the output unit are disposed substantially between the first port and the second port.