Syringe configured to indicate arterial puncture

The syringe, equipped with an arterial indicator that provides feedback upon reaching arterial pressure, addresses the challenge of determining needle placement within arteries or veins, improving access success and patient comfort.

WO2025058909A1PCT designated stage expired Publication Date: 2025-03-20BECTON DICKINSON & CO
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Patent Information

Application Number
PCT/US2024/045194
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-11
Filing Date
2024-09-04
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Clinicians face difficulties determining whether a needle is inserted inside an artery or vein, leading to failed access attempts and patient discomfort.

Method used

A syringe configured with a barrel, plunger, and arterial indicator, which provides visual and/or haptic feedback when the needle is positioned within an artery or vein by resisting movement until arterial pressure is reached.

Benefits of technology

The syringe effectively provides feedback to clinicians, indicating arterial puncture, thereby reducing failed access attempts and enhancing patient comfort.

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Abstract

A syringe can be configured to indicate arterial puncture. Such a syringe can be used to determine when a needle that has been inserted into the patient is within an artery or vein. The syringe can be configured to provide visual feedback and / or haptic feedback representing the arterial puncture.
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Description

SYRINGE CONFIGURED TO INDICATE ARTERIAL PUNCTUREBACKGROUND

[0001] Clinicians have had difficulties determining whether a needle is inside an artery or vein such as when placing a central line. These difficulties oftentimes lead to failed access attempts and patient discomfort.

[0002] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.SUMMARY

[0003] The present disclosure relates generally to a syringe that is configured to indicate arterial puncture. Such a syringe can be used to determine when a needle that has been inserted into the patient is within an artery or vein. The syringe can be configured to provide visual feedback and / or haptic feedback representing the arterial puncture.

[0004] In some embodiments, a syringe configured in accordance with one or more embodiments of the present disclosure may include a barrel, a plunger, and an arterial indicator.

[0005] In some embodiments, the plunger may be movable with respect to the barrel to a depressed position.

[0006] In some embodiments, the arterial indicator may be at least partially positioned inside the barrel when the plunger is in the depressed position.

[0007] In some embodiments, the plunger may include a plunger channel within which the arterial indicator is positioned.

[0008] In some embodiments, the plunger channel may extend between and through distal and proximal ends of the plunger.

[0009] In some embodiments, the arterial indicator may include a rod and a seal at a distal end of the rod.

[0010] In some embodiments, the seal may be configured to resist movement of the arterial indicator within the plunger channel until a threshold pressure exists distal to the seal.

[0011] In some embodiments, the threshold pressure may be arterial pressure.

[0012] In some embodiments, the arterial indicator may include a flange that extends proximally out from the plunger channel.

[0013] In some embodiments, the plunger may include a section that is visible through the barrel. The section may be proximally offset from a distalmost position of the seal.

[0014] In some embodiments, the plunger may include one or more blocks within the plunger channel to limit proximal movement of the arterial indicator within the plunger channel.

[0015] In some embodiments, a wall of the plunger channel may be formed of glass.

[0016] In some embodiments, the arterial indicator may include a door across the plunger channel and a bellow positioned over an opening of the plunger channel.

[0017] In some embodiments, the arterial indicator may include a stopper against which the door rests when the door is in a closed position.

[0018] In some embodiments, a syringe configured in accordance with one or more embodiments of the present disclosure may include a barrel having an adapter at a distal end. The barrel forms a chamber. The syringe may also include a plunger that inserts through a proximalend of the barrel into the chamber. The plunger may form a plunger channel. The syringe may further include an arterial indicator positioned within the plunger channel.

[0019] In some embodiments, the plunger channel may extend between and through distal and proximal ends of the plunger.

[0020] In some embodiments, the arterial indicator may include a rod having a seal at a distal end and a flange at a proximal end.

[0021] In some embodiments, the flange may extend proximally beyond the proximal end of the plunger.

[0022] In some embodiments, the seal may be configured to prevent the arterial indicator from sliding proximally within the plunger channel until a threshold pressure exists distal to the seal.

[0023] In some embodiments, the threshold pressure may be arterial pressure.

[0024] In some embodiments, the plunger channel may include one or more blocks that limit proximal movement of the arterial indicator within the plunger channel.

[0025] In some embodiments, the plunger may include a section that is visible through the barrel. The section may be proximally offset from a distalmost position of the seal at a distance corresponding to a distance that the arterial indicator should travel when the threshold pressure is reached.

[0026] In some embodiments, a syringe configured in accordance with one or more embodiments of the present disclosure may include a barrel forming a chamber and having an adapter by which the syringe may be coupled to a needle, a plunger that is slidably positioned within the chamber, the plunger forming a plunger channel, and an arterial indicator positioned within the plunger channel. The arterial indicator is configured to provide feedback when the needle is positioned within an artery or vein.

[0027] In some embodiments, the arterial indicator may be configured to slide proximally within the plunger channel when the needle is positioned within an artery or vein by resisting movement until a threshold pressure exists distal to the arterial indicator.

[0028] In some embodiments, the threshold pressure may be arterial pressure.

[0029] It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0030] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0031] Figure 1 is an example of a syringe that is configured in accordance with one or more embodiments of the present disclosure;

[0032] Figure 2 is a cross-sectional view of a syringe that is configured in accordance with one or more embodiments of the present disclosure;

[0033] Figures 3A and 3B provide an example of how a syringe that is configured in accordance with one or more embodiments of the present disclosure can indicate an arterial puncture; and

[0034] Figures 4A and 4B are cross-sectional views of another syringe that is configured in accordance with one or more embodiments of the present disclosure.DESCRIPTION OF EMBODIMENTS

[0035] Figures 1 and 2, which are perspective and cross-sectional views respectively, provide an example of a syringe 100 that is configured in accordance with one or more embodiments of the present disclosure. Syringe 100 includes a barrel 110 and a plunger 120. Barrel 110 includes an adapter 111 (e.g., a luer lock or slip lock) at its distal end and a finger flange 112 at its proximal end. Barrel 110 also forms a chamber 113 that extends between and through adapter 111 and finger flange 112. Plunger 120 includes a rod 121 with a thumb rest 122 at its proximal end and a stopper 123 at its distal end. Stopper 123 forms a seal against the wall of chamber 113. Plunger 120 also includes a plunger channel 124 that extends between and through the distal and proximal ends of plunger 120. Figures 1-2 illustrate the plunger in a depressed position, according to some embodiments.

[0036] Syringe 100 further includes an arterial indicator 130 that is positioned within plunger channel 124. Arterial indicator 130 includes a rod 131 with a flange 132 at its proximal end and a seal 133 at its distal end. Seal 133 is configured to contact and form a seal against the wall of plunger channel 124. Seal 133 can be configured to prevent movement of arterial indicator 130 within plunger channel 124 until a threshold pressure exists on the distal side of seal 133. For example, this threshold pressure can correspond with a typical arterial pressure such as approximately 30mmHg so that seal 133 will only slide within plunger channel 124 if a needle to which syringe 100 is coupled is positioned within an artery or vein. In some embodiments, seal133 can be configured to resist movement at pressures below the threshold pressure by forming seal 133 and / or plunger channel 124 from a particular material and / or with a particular shape or size to create an appropriate coefficient of friction. In some embodiments, the wall of plunger channel 124 may be formed of glass having low friction to increase pressure sensitivity of arterial indicator 130. In some embodiments, blocks 125 may be positioned within plunger channel 124 to limit the proximal movement of arterial indicator 130 (e.g., to prevent arterial indicator 130 from escaping plunger channel 124).

[0037] The threshold pressure at which seal 133 will allow arterial indicator 130 to slide proximally can be insufficient to cause plunger 120 to move proximally within chamber 113. In other words, when the needle is inserted into an artery or vein thus causing chamber 113 to be exposed to arterial pressure, arterial indicator 130 can slide proximally relative to plunger 120 while plunger 120 remains stationary relative to barrel 110. This proximal movement of arterial indicator 130 relative to plunger 120 provides feedback to the clinician that the needle is positioned within the artery or vein. This feedback can be visual feedback given that the clinician can see arterial indicator 130 protruding proximally from plunger 120. This feedback can also be haptic feedback as flange 132 may contact the clinician’s hand.

[0038] In some embodiments, plunger 120 may be configured to provide visual feedback for determining when the threshold pressure exists within chamber 113. For example, as represented in Figure 2, a section 126 of rod 121 can have a different color, pattern, or other visual distinction that can be seen through barrel 1 10. Section 126 can be offset proximally from the distal end of rod 121 (or from a distalmost position of seal 133) at a distance that represents how far seal 133 should travel when chamber 113 is exposed to arterial pressure. Seal 133 can also be visiblethrough barrel 110 so that the clinician can see when seal 133 is positioned within section 126 to thereby determine that the needle is positioned within an artery or vein.

[0039] Figures 3 A and 3B provide an example of how syringe 100 can indicate when a needle is positioned within an artery or vein. In Figure 3 A, a needle 300 is coupled to adapter 111 and it is assumed that needle 300 is not yet inserted into an artery or vein. Accordingly, blood is not present within needle 300 or chamber 113, and seal 133 remains at its distalmost position within plunger channel 124. In this distalmost position, seal 133 is distal to section 126. Turning to Figure 3B, it is now assumed that needle 300 is positioned within an artery or vein such that blood 301 has entered needle 300 and chamber 113. As a result of the blood / arterial pressure, seal 133 is forced proximally within plunger channel 124 to cause seal 133 to be positioned within section 126. In this way, the proximal movement of arterial indicator 130 can provide visual and / or haptic feedback to the clinician of the arterial puncture. Notably, stopper 123 prevents plunger 120 from sliding proximally in response to the arterial pressure. If the clinician desired to again confirm arterial puncture, such as if needle 300 were adjusted, the clinician could push arterial indicator 130 back into plunger channel 124. If arterial pressure still exists within chamber 113, the pressure will force arterial indicator 130 back towards or against blocks 125. Due to the confirmation of the arterial puncture, the clinician can proceed with an injection or blood draw using syringe 100 with confidence that the needle is properly positioned within the artery or vein.

[0040] Figures 4A and 4B provide another example of a syringe 400 that is configured in accordance with one or more embodiments of the present disclosure. Syringe 400 is similar to syringe 100 in that it includes a barrel 110 and a plunger 120 as described above. However, syringe 400 does not include arterial indicator 130. Instead, syringe 400 includes an arterial indicator 410formed by a door 41 1 that is positioned within plunger channel 124 and a bellows 413 positioned overtop an opening of plunger channel 124.

[0041] Door 411 can be configured to pivot (e.g., about a pin 41 la) within plunger channel 124 in response to an increase in arterial pressure within chamber 113. In particular, Figure 4A shows door 411 in a closed position in which it may rest on a stopper 412. In some embodiments, door 411 may be biased against stopper 412 such as by spring-loading pin 411a. Stopper 412 may be positioned relative to door 411 so that door 411 is substantially perpendicular to plunger channel 124 when in the closed position. Door 411 can be configured to form a seal against the wall of plunger channel 124 and can maintain this seal until arterial pressure exists below door 411.

[0042] Bellows 413 can span and seal the opening of plunger channel 124 at thumb rest 122. Bellows 413 can function to provide visual and / or haptic feedback when a needle is inserted into a patient’s artery or vein. For example, in Figure 4 A, it is assumed that needle 300 has not yet been inserted into an artery or vein. In such a case, plunger channel 124 may be filled with air at atmospheric pressure on both sides of door 411 such that bellows 413 will not be inflated. Then, in Figure 4B, it is assumed that needle 300 has been inserted into an artery or vein thus exposing plunger channel 124 below door 411 to arterial pressure (e.g., as blood 301 flows into / towards chamber 113). This increased pressure below door 411 can cause door 411 to pivot upwardly into an open position (e.g., by overcoming a frictional force between door 411 and the walls of plunger channel 124 and / or by overcoming a force that biases door 411 into the closed position) thereby exposing plunger channel 124 above door 41 1 to arterial pressure. As a result of this increased pressure, air from within plunger channel 124 will be forced into bellows 413 to thereby inflate bellows 413. Accordingly, the inflation of bellows 413 can notify the clinician that needle 300 is positioned within an artery or vein. In some embodiments, bellows 413 can be configured torepeatedly inflate and deflate in conjunction with changes in arterial pressure due to pulses. For example, in response to the pulses in arterial pressure, door 411 may repeatedly open and close.

[0043] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.

Claims

CLAIMSWhat is claimed:

1. A syringe comprising: a barrel; a plunger movable with respect to the barrel to a depressed position; and an arterial indicator at least partially positioned inside the barrel when the plunger is in the depressed position.

2. The syringe of claim 1, wherein the plunger includes a plunger channel within which the arterial indicator is positioned.

3. The syringe of claim 2, wherein the plunger channel extends between and through distal and proximal ends of the plunger.

4. The syringe of claim 2, wherein the arterial indicator comprises a rod and a seal at a distal end of the rod.

5. The syringe of claim 4, wherein the seal is configured to resist movement of the arterial indicator within the plunger channel until a threshold pressure exists distal to the seal.

6. The syringe of claim 5, wherein the threshold pressure is arterial pressure.

7. The syringe of claim 4, wherein the arterial indicator includes a flange that extends proximally out from the plunger channel.

8. The syringe of claim 4, wherein the plunger includes a section that is visible through the barrel, the section being proximally offset from a distalmost position of the seal.

9. The syringe of claim 4, wherein the plunger includes one or more blocks within the plunger channel to limit proximal movement of the arterial indicator within the plunger channel.

10. The syringe of claim 4, wherein a wall of the plunger channel is formed of glass.

11. The syringe of claim 3, wherein the arterial indicator comprises a door across the plunger channel and a bellows positioned over an opening of the plunger channel.

12. The syringe of claim 11, wherein the arterial indicator comprises a stopper against which the door rests when the door is in a closed position.

13. A syringe comprising: a barrel having an adapter at a distal end, the barrel forming a chamber; a plunger that inserts through a proximal end of the barrel into the chamber, the plunger forming a plunger channel; and an arterial indicator positioned within the plunger channel.

14. The syringe of claim 13, wherein the plunger channel extends between and through distal and proximal ends of the plunger.

15. The syringe of claim 14, wherein the arterial indicator includes a rod having a seal at a distal end and a flange at a proximal end.

16. The syringe of claim 15, wherein the flange extends proximally beyond the proximal end of the plunger.

17. The syringe of claim 16, wherein the seal is configured to prevent the arterial indicator from sliding proximally within the plunger channel until a threshold pressure exists distal to the seal.

18. The syringe of claim 17, wherein the threshold pressure is arterial pressure.

19. A syringe comprising: a barrel forming a chamber and having an adapter by which the syringe may be coupled to a needle; a plunger that is slidably positioned within the chamber, the plunger forming a plunger channel; and an arterial indicator positioned within the plunger channel, the arterial indicator being configured to provide feedback when the needle is positioned within an artery or vein.

20. The syringe of claim 18, wherein the arterial indicator is configured to slide proximally within the plunger channel when the needle is positioned within an artery or vein by resisting movement until a threshold pressure exists distal to the arterial indicator.

Citation Information

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