Vascular access device and method of use

Abstract

A vascular access device includes a base housing and a needle guide extending from the base housing at an acute angle. The vascular access device also includes an acoustic sensor disposed in the base housing and configured to output a detection signal in response to detecting an acoustic signal generated by a blood vessel. The vascular access device further includes an indicator coupled to the acoustic sensor and configured to output an indication based on the detection signal.

Description

VASCULAR ACCESS DEVICE AND METHOD OF USECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application Serial No. 63 / 600,102 filed on November 17, 2023. The entire contents of the foregoing application are incorporated by reference herein.BACKGROUND

[0002] The radial, ulnar, and brachial arteries can be used for arterial catheterization of the upper extremity. Arterial pressure monitoring is essential for the management of hemodynamically unstable patients. The placement of an arterial catheter is sometimes technically challenging because some arteries have small calibers, anatomic variations, or arterial calcifications, or vasospasms. Multiple cannulation attempts are associated with a higher failure rate and complications such as hematoma, hemorrhage, vasospasm, occlusion, and infection. Ultrasound is a useful tool for peripheral arterial catheterization. Ultrasound guidance has been shown to facilitate arterial catheterization with fewer attempts. Ultrasound guidance for arterial catheterization improves the first and second attempt success rates and decreases the rate of complications compared to palpation or Doppler assistance. In addition, ultrasound is a good modality for evaluating the extent of the artery in vasospasm as well as relaxation of the spasm after treatment. There is a need for an apparatus that avoids the use of expensive ultrasound machines and simplifies the process of arterial access.SUMMARY

[0003] According to one embodiment of the present disclosure, a vascular access device is disclosed. The vascular access device includes a base housing and a needle guide extending fromthe base housing at an acute angle. The vascular access device also includes an acoustic sensor disposed in the base housing and configured to output a detection signal in response to detecting an acoustic signal generated by a blood vessel. The vascular access device further includes an indicator coupled to the acoustic sensor and configured to output an indication based on the detection signal.

[0004] According to another embodiment of the present disclosure, a method for vascular access is disclosed. The method includes placing a vascular access device over tissue including a blood vessel. The vascular access device further includes a base housing and a needle guide extending from the base housing at an acute angle. The method also includes activating an acoustic sensor disposed in the base housing and configured to output a detection signal in response to detecting an acoustic signal generated by the blood vessel. The method additionally includes moving the vascular access device until an indicator coupled to the acoustic sensor outputs an indication based on the detection signal indicating the vascular access device is positioned over the blood vessel. The method further includes inserting a needle through the needle guide into the blood vessel.

[0005] Implementations of the above embodiments may include one or more of the following features. According to one aspect of the above embodiment, the acute angle of the needle guide may be about 45°. The indicator may be one or more light emitters such as an LED. Intensity of light emitted by the LED(s) corresponds to an amplitude of the detection signal. The light emitters may be arranged in a linear orientation transverse or longitudinal to the artery to assist the user in localizing the target artery. The vascular access device may include a signal processor configured to process the detection signal. The indicator may be a speaker. The amplitude of an audio tone emitted by the speaker corresponds to the amplitude of the detection signal. Theneedle guide may have a longitudinal tubular structure. The longitudinal tubular structure may not be fully enclosed, but more of a half-cylinder or other shaped needle guide. The base housing and the needle guide may be formed from a polymer, which may be one of polycarbonate, polypropylene, acrylonitrile butadiene styrene, polyethylene terephthalate glycol, polyethylene, polymethyl methacrylate, polyvinyl chloride, and combinations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:

[0007] FIG. 1 is a diagram of a patient’s radial and ulnar arteries;

[0008] FIG. 2 is a side view of a vascular access device according to an embodiment of the present disclosure;

[0009] FIG. 3 is a top view of the vascular access device of FIG. 2; and

[0010] FIG. 4 is a schematic view of the vascular access device of FIG. 2.DETAILED DESCRIPTION

[0011] Embodiments of the present disclosure are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term “proximal” refers to the portion of a device that is closer to the user, while the term “distal” refers to the portion that is farther from the user. The term “about” denotes a range of ±5% from the stated value.

[0012] FIG. 1 shows a patient’s hand having a radial artery and an ulnar artery that may be accessible using a vascular access device 10 (FIG. 2). It is envisioned that the vascular accessdevice 10 may be used on any blood vessel and that the radial and ulnar arteries described herein are exemplary.

[0013] The radial artery is commonly used for arterial catheterization because of adequate collateral blood supply, low complication rates, and easy accessibility. The average diameter of the radial artery in adults and children may be 2.2-2.3 ± 0.4 mm and 1.2-1.3 ± 0.2 mm, respectively. The average depth of the radial artery from the skin in adults and children may be 2.5 ± 0.3 mm and 2.3 ± 0.7 mm, respectively. The radial artery originates from the brachial artery and reaches the lateral side of the wrist. After the radial artery divides into the superficial and deep branches at the styloid process level of the radial head, the radial and ulnar arteries are connected with the superficial palmar and deep palmar arches.

[0014] The ulnar artery is smaller than the radial artery in the palpable region of the wrist, although it is larger than the radial artery at the division site just below the elbow. The average diameter of the ulnar artery in adults may be 2.3-2.5 ± 0.5 mm, which is smaller than the radial artery at the wrist level. The ulnar artery is a branch of the brachial artery and runs along the medial side of the wrist. The artery is located lateral to the ulnar nerve and flexor carpi ulnaris tendon in the palpable region of the wrist.

[0015] In addition to radial and ulnar arteries, the vascular access device 10 may be used to establish access in any other arteries or veins, including but not limited to, other vessels located in the arm, such as brachial vessels or basilic vein, vessels located in the neck, such as carotid and other cervical blood vessels, lower extremity vessels, such as femoral blood vessels or popliteal vessels, and the like.

[0016] With reference to FIGS. 2 and 3, the vascular access device 10 includes a base housing 12 which includes circuitry for identifying sounds generated by the blood flow of the arterybeing accessed. The vascular access device 10 uses the sound from an artery to localize the center of a blood vessel and contains a fixture, i.e., needle guide 14, to guide an introducer needle 16 into the vessel at a suitable angle enabling safe and reproducible vascular access in a variety of medical environments without requiring an expensive or cumbersome ultrasound machine.

[0017] The needle guide 14 may have a longitudinal tubular structure, which extends from the base housing 12 and defines a lumen 15 through the needle guide 14, which allows for insertion of the introducer needle 16 into the artery. The needle guide 14 includes a proximal end 18 defining an opening 18a and distal end 19 contacting the base housing 12. The lumen 15 passes through the needle guide 14 and the base housing 12 and terminates at a bottom (i.e., tissue contacting) surface of the base housing 12 in an opening 19a. The needle 16 may have a gauge from 16 to 21 and may be from about 20 mm to about 60 mm long. The lumen 15 as well as the openings 18a and 19a may have a diameter suitable for accommodating the needle 16 and may be about from about 1 mm to about 5 mm. In embodiments the needle guide 14 may be a halfpipe or have another trough shape having a triangular or polygonal cross-section suitable for sliding the needle 16.

[0018] The needle guide 14 may extend from the base housing 12 at any suitable acute angle, which may be from about 30° to about 60°, and in embodiments may be about 45°. The base housing 12 and the needle guide 14 may be formed from any suitable biocompatible material including, but not limited to, polycarbonate, polypropylene, acrylonitrile butadiene styrene, polyethylene terephthalate glycol, polyethylene, polymethyl methacrylate, polyvinyl chloride, and combinations thereof. The base housing 12 and the needle guide 14 may be formed using any suitable manufacturing technique, e.g., injection molding, 3D printing, etc. as individual ormultiple parts which are assembled and secured together, e.g., via adhesives, sonic welding etc. In embodiments, the vascular access device 10 may be formed as a unitary, integral piece.

[0019] With reference to FIGS. 3 and 4, the base housing 12 includes an acoustic sensor 20 configured to detect sounds generated by the blood flow of the artery being accessed. The base housing 12 may have any suitable shape, e.g., rectangular, oval, etc. and the acoustic sensor 20 may be centrally disposed on a central axis “X-X” defined by the base housing 12 along with the needle guide 14. The acoustic sensor 20 may be a microphone or any other type of acoustic transducer configured to measure sound, such as a flexible membrane transducer, a microelectromechanical systems (MEMS) microphone, an electret diaphragm microphone, or any other microphone. The acoustic sensor 20 may have a frequency range from about 10 Hz to about 10 kHz.

[0020] The signal of the acoustic sensor 20 is provided to a signal processor 22, which may be digital or analog processing circuit and is configured to process the signal, e.g., isolate, filter, amplify a blood flow sound waveform. The signal processor 22 is configured to block and / or pass certain frequencies and may include one or more of the following filters: high pass, low pass, band pass, notch filters and / or digital equivalents thereof. The signal processor 22 is also configured to remove ambient sounds (e.g., voices) from detected blood flow sound waveforms. The filtered sound waveform signal may also be amplified through an amplifier such that the sound is output at the supraphy si ologi cal level.

[0021] The signal processor 22 is also coupled to one or more output devices, which may be audio or visual indicators, such as one or more LEDs 24 and a speaker 26, respectively. The base housing 12 further includes a voltage source, such as a battery 21, configured to power the circuit components, such as the acoustic sensor 20, the signal processor 22, the LEDs 24, and thespeaker 26. In embodiments, the vascular access device 10 may include one or more electrical contacts 23 which may be used to couple to a connector of an external electrical power source (not shown). The external power source may be used for charging the battery 21 when the vascular access device 10 is not in use or to provide power directly to the components of the vascular access device 10. The vascular access device 10 also includes a switch 25 configured to toggle the acoustic sensor 20 and other components on and off.

[0022] The LEDs 24 are configured to light up based on the amplitude of the output signal of the signal processor 22. In embodiments, the number and / or intensity of the LEDs 24 changes based on the amplitude of the output signal. The LEDs 24 may light up in a sequence, i.e., initially outside LEDs 24 are lit up as the signal reaches a first threshold and the inner LEDs 24 is lit up once the signal reaches a second, higher threshold. The sequence may be used to indicate that the acoustic sensor 20 is disposed over the artery.

[0023] Similarly, the speaker 26 may output a continuous audio tone that changes in intensity in response to the amplitude of the output signal of the signal processor 22. Thus, the louder the tone, the closer is the acoustic sensor 20 to the artery being accessed. The acoustic sensor 20 is disposed next to, e.g., 1-4 mm away from, the distal opening 19a such that the point of the entry of the needle 16 coincides with the source of the sound detected by the acoustic sensor 20. The acoustic sensor 20 may also be disposed in contact with the bottom surface of the base housing 12 to maximize transmission of sound waves.

[0024] During use, the user activates the switch 25 and places the vascular access device 10 onto the tissue site to identify the location of the vessel, e.g., radial artery, such that the bottom surface of the base housing 12 contacts the skin. The vascular access device 10 may be moved around and / or side to side of the approximate location of the blood vessel while the acousticsensor 20 is activated. The sound and / or visual cues provided by the speaker 26 and / or the LEDs 24, respectively, are used to determine the location of the artery. Once identified, the vascular access device 10 is held in place while the needle 16 is inserted through the needle guide 14 into the blood vessel.

[0025] The vascular access device 10 democratizes the ability to gain vascular access using an inexpensive device that is small, portable, possibly battery powered, and potentially disposable. This can be used in the ICU or emergency department settings by practitioners with various licenses and levels of training. Emergency medical technicians can use the device in the field to help guide vascular access. Field medics would have technology to guide vascular access for the first time. Physicians using the device would be able to quickly and safely access even very small vessels with high reproducibility and requiring little training.

[0026] It will be appreciated that of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims. Unless specifically recited in a claim, steps or components of claims should not be implied or imported from the specification or any other claims as to any particular order, number, position, size, shape, angle, or material.

Claims

WHAT IS CLAIMED IS:

1. A vascular access device comprising: a base housing; a needle guide extending from the base housing at an acute angle; an acoustic sensor disposed in the base housing and configured to output a detection signal in response to detecting an acoustic signal generated by a blood vessel; and an indicator coupled to the acoustic sensor and configured to output an indication based on the detection signal.

2. The vascular access device according to claim 1, wherein the acute angle is approximately 45°.

3. The vascular access device according to claim 1, wherein the indicator is at least one LED.

4. The vascular access device according to claim 3, wherein intensity of light emitted by the at least one LED corresponds to an amplitude of the detection signal.

5. The vascular access device according to claim 4, further comprising a signal processor coupled to the acoustic sensor and configured to process the detection signal.

6. The vascular access device according to claim 1, wherein the indicator is a speaker.

7. The vascular access device according to claim 6, wherein amplitude of an audio tone output by the speaker corresponds to an amplitude of the detection signal.

8. The vascular access device according to claim 1, wherein the needle guide has a longitudinal tubular structure.

9. The vascular access device according to claim 1, wherein the base housing and the needle guide are formed from a polymer selected from the group consisting of polycarbonate, polypropylene, acrylonitrile butadiene styrene, polyethylene terephthalate glycol, polyethylene, polymethyl methacrylate, polyvinyl chloride, and combinations thereof.

10. A method for vascular access, the method comprising: placing a vascular access device over tissue including a blood vessel, the vascular access device including a base housing and a needle guide extending from the base housing at an acute angle; activating an acoustic sensor disposed in the base housing and configured to output a detection signal in response to detecting an acoustic signal generated by the blood vessel; moving the vascular access device until an indicator coupled to the acoustic sensor outputs an indication based on the detection signal indicating the vascular access device is positioned over the blood vessel; and inserting a needle through the needle guide into the blood vessel.

11. The method according to claim 10, wherein the acute angle is about 45°.

12. The method according to claim 10, wherein the indicator is at least one LED.

13. The method according to claim 12, wherein intensity of light emitted by the at least one LED corresponds to an amplitude of the detection signal.

14. The method according to claim 13, further comprising processing the detection signal at a signal processor coupled to the acoustic sensor.

15. The method according to claim 10, wherein the indicator is a speaker.

16. The method according to claim 15, wherein amplitude of an audio tone output by the speaker corresponds to an amplitude of the detection signal.

17. The method according to claim 10, wherein the needle guide has a longitudinal tubular structure.

18. The method according to claim 10, wherein the base housing and the needle guide are formed from a polymer selected from the group consisting of polycarbonate, polypropylene, acrylonitrile butadiene styrene, polyethylene terephthalate glycol, polyethylene, polymethyl methacrylate, polyvinyl chloride, and combinations thereof.

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