Pulsed or resonant irrigation syringe

The syringe generates pulsed flow using fluid momentum and resonance to improve catheter cleaning efficiency by reducing mechanical interaction and part count, addressing inefficiencies in conventional designs.

JP7742389B2Active Publication Date: 2025-09-19BECTON DICKINSON & CO
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Patent Information

Application Number
JP2023175937
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2018-01-28
Filing Date
2023-10-11
Publication Date
2025-09-19
Estimated Expiration
2039-01-25

AI Technical Summary

Technical Problem

Conventional irrigation syringes for IV catheters generate pulsed flow through mechanical interaction between the syringe plunger and barrel, which can cause a hammering impact on the clinician and require additional components, making them inefficient and cumbersome.

Method used

The syringe generates pulsed flow using the momentum of the fluid itself, employing rotating wheels or resonating components within the syringe barrel to induce rotational velocity and resonance, reducing mechanical interaction and simplifying the design.

Benefits of technology

This approach reduces the sensation of hammering impact on the clinician and minimizes the number of parts, potentially lowering manufacturing costs while providing efficient and effectively flushing the catheter by, for example, providing a pulsed, pulsatile, and/or to create a pulsating flow profile that enhances cleaning efficiency.

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Abstract

To reduce influence of a syringe plunger on a clinical person when performing a flushing operation and / or avoid use of an additional inline device.SOLUTION: A flush syringe comprises: a barrel which has a side wall extending from a base end part to a terminal part and defines a chamber that stores fluid; a syringe tip being the syringe tip which is arranged on the terminal part of the barrel, the fluid exiting from the barrel through the syringe tip; and a flushing mechanism having a flexible member which is arranged in the flow of the fluid that resonates over the range of the speed of the flow of the fluid. The flushing mechanism generates the pulse-like flow in the flow of the fluid existing from the syringe tip via the flushing mechanism from the chamber.SELECTED DRAWING: Figure 2A
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Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. § 119(e) from U.S. Provisional Patent Application No. 62 / 622,907, filed January 28, 2018, the contents of which (including all attachments filed therewith) are incorporated herein by reference in their entirety.

[0002] Technical Field In general, exemplary embodiments of the present disclosure relate to the field of vascular access devices, particularly cleaning devices for use in maintaining intravenous (IV) catheters. [Background technology]

[0003] background In medical applications, various procedures have been used to flush IV catheters to prevent blockages, which are potential sources of infection, and / or to clear bacteria and prevent bacterial colonization of IV catheters. Non-Patent Document 1 (Agnes Ferroniet et al. "Pulsative Flushing As A Strategy To Prevent Bacterial Colonization Of Vascular Access Devices" (Medical Devices: Evidence and Research 2014:7 379-383, Doverpress 2004) (the entire disclosure of which is incorporated herein by reference) cites a study demonstrating that the use of pulsed flow, sometimes referred to as "start-stop" flushing, which applies alternating high and low forces to the syringe plunger, is more than twice as effective at clearing bacteria from IV catheters compared to continuous (constant flow) flushing.

[0004] Conventional techniques involve manually generating a pulsed flow from conventional irrigation syringe designs, typically by manually applying alternating high and low forces to the syringe plunger. Other means of generating a pulsed flow from an irrigation syringe are described in U.S. Pat. No. 8,491,537 and U.S. Published Patent Application No. 2010 / 0076370, the disclosures of both of which are incorporated herein by reference in their entireties.

[0005] 1A and 1B, includes a syringe barrel 110 having an open proximal end 119 and a distal end 111 with a collar 121, a tip cap 124 for engaging with the collar 121, a plunger rod 130 disposed within the syringe barrel 110, a stopper 160 attached to one end 133 of the plunger rod 130, a thumb press 170 attached to a second end of the plunger rod 130, and a pulse control element 190 disposed between the thumb press 170 and the plunger rod 130. The pulse element 136 is provided as a protrusion disposed along the length of the plunger rod 130 that engages with the pulse element 126, and is provided as a protrusion disposed on the inner surface of the syringe barrel 110, causing a pulsing motion of the plunger rod 130 as it moves at least distally within the syringe barrel 110.

[0006] U.S. Patent Application Publication No. 2010 / 0076370 describes other variations in plunger rod and barrel designs, as well as an in-line pulse device for generating pressure pulses to provide turbulent flow for purging, as illustrated in Figures 9-14 of U.S. Patent Application Publication No. 2010 / 0076370, in which an in-line automatic pulse device 310 has an upstream or proximal connection 320 to which liquid from a liquid source is supplied and an output port and connector 330 that may be connected to a downstream catheter system; in Figures 15-17, a pinch or squeeze pump 410 has an upstream or proximal connection 420 to which liquid from a liquid source is supplied and an output port and connector 430 that may be connected to a downstream catheter system; and in Figures 18-20, a device 510 for providing manually or digitally generated controlled pressure pulses for purging a catheter system has an upstream or proximal connection 520 to which liquid from a liquid source is supplied and an output port and connector 530 that may be connected to a downstream catheter system.

[0007] Both U.S. Patent No. 8,491,537 and U.S. Patent Application Publication No. 2010 / 0076370 describe embodiments in which a pulsed fluid flow may be generated by mechanical interference and interaction between features on the syringe plunger rod and features on the syringe barrel, and / or by an additional in-line pulsing device. Alternative embodiments that can reduce the impact of the syringe plunger on the clinician when performing a flushing operation and / or avoid the use of an additional in-line device are desirable. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 8,491,537 [Patent Document 2] US Patent Application Publication No. 2010 / 0076370 [Non-patent literature]

[0009] [Non-Patent Document 1] Agnes Ferroniet al. “Pulsative Flushing As A Strategy To Prevent Bacterial Colonization Of Vascular Access Devices” (Medical Devices: Evidence and Research 2014:7 379-383, Doverpress 2004 Summary of the Invention

[0010] overview The matters exemplified in this detailed description are provided to help comprehensively understand the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications to the embodiments described herein can be made without departing from the scope and spirit of the present disclosure. Also, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0011] As would be readily understood by one skilled in the relevant art, terms such as "pulse," "pulsed," "flow," "distal," "proximal," "irrigation," "syringe," "wheel," "vane," "slope," "wall," "top," "side," "bottom," and other descriptive terms are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination, or individually, to implement various aspects of embodiments of the present disclosure.

[0012] Exemplary embodiments of the present disclosure provide an irrigation syringe for use in maintaining an intravenous catheter that can more efficiently and effectively flush the catheter by, for example, providing a pulsed, pulsatile, and / or pulsed flow of fluid rather than a constant flow. In exemplary embodiments, the pulsed flow is generated using the momentum of the moving fluid itself, rather than by the mechanical action of, for example, a syringe plunger. According to exemplary embodiments, a clinician operating a syringe in accordance with exemplary embodiments of the present disclosure can apply a steady force to the plunger to provide a pulsed flow of fluid to the catheter during flushing.

[0013] According to an exemplary embodiment of the present disclosure, a pulsating flow may be generated by a flowing fluid causing rotation of a wheel having blades disposed in the flowing fluid. In an exemplary embodiment, the blades may be non-tilted, and a rotational velocity component may be induced in the fluid before the fluid impinges on the non-tilted blades. In another exemplary embodiment, the blades may be tilted, and the tilt of the blades may induce a rotational velocity component in the fluid. In yet another exemplary embodiment, the configuration of the tilted blades on the wheel may be similar to that of a turbine or pinwheel.

[0014] In further exemplary embodiments of the present disclosure, the rotating wheel can include one or more openings that alternately cover and uncover outlet orifices downstream of the wheel, e.g., starting and stopping fluid flow at each outlet orifice to provide a pulsed flow through the syringe tip.

[0015] According to further exemplary embodiments of the present disclosure, the pulsed flow can be caused by the movement of the fluid being injected at the tip of the syringe barrel, such that pressure waves in the fluid can be damped before reaching, for example, the syringe plunger and the user's thumb or finger. An exemplary, non-limiting advantage that can be achieved is a reduction in the sensation to the clinician of having a hammering impact caused by the prior embodiment, which may occur when the syringe plunger interacts with alternating features on the syringe barrel or other components.

[0016] According to another exemplary embodiment of the present disclosure, an irrigation syringe is configured to generate a pulsed or pulsatile flow to an IV catheter for more efficient irrigation using resonance of one or more components to generate a pulsed flow. In the exemplary embodiment, the underlying technical principle involves the resonance of a flexible body due to the interaction between pressure differences and turbulence as fluid flows around the body, and the flexibility of the body allowing it to distort due to pressure fluctuations along its surface and turbulent velocity eddies. Exemplary, non-limiting advantages of the provided exemplary embodiment include the use of fewer total parts and no moving parts, which may require tighter tolerances.

[0017] In exemplary embodiments, one or more members may be structurally flexible and / or disposed internally within the irrigation syringe. In exemplary embodiments, the present disclosure provides additional components to existing irrigation syringe designs, which may be flexible and rigidly disposed relative to mating components or attachment points on the irrigation syringe. Exemplary, non-limiting advantages include potentially allowing for looser tolerances, further reducing manufacturing costs.

[0018] In exemplary embodiments of certain embodiments of the present disclosure, the pulsating fluid flow is generated from resonance caused by the interaction of one or more flexible members with the fluid flowing through the syringe and into the catheter. The resonance of the flexible members alternately disrupts or restricts the fluid flow, creating a pulsating flow profile (varying the flow pressure / velocity) that is beneficial for improving cleaning. Alternatively, in exemplary embodiments, the resonance can create pressure waves in the flow without disrupting or restricting the fluid flow (e.g., as sound pressure waves move through a liquid).

[0019] An exemplary embodiment of the present disclosure provides a resonating component that includes a relatively thin, wide tube that is nominally closed. Fluid ejected from a flushing syringe passes through the tube, causing the walls of the tube to alternately open and close relative to one another in a "fluttering" manner. In the exemplary embodiment, the thin-walled tube walls resonate with one another, creating a pulsating flow that exits the syringe. In a non-limiting example, the operating mechanism resembles the "buzzing" sound of a balloon neck as air is released from the balloon neck.

[0020] Another exemplary embodiment of the present disclosure provides a resonating component that includes an elongated tube through which fluid discharged from a flushing syringe flows. In the exemplary embodiment, at least a portion or all of the tube whips due to the exit velocity of the fluid at the tip of the tube. In a non-limiting example, the operating mechanism is similar to the whipping of a fire hose (or other high-pressure hose) when high-velocity fluid flows through it.

[0021] Yet another exemplary embodiment of the present disclosure provides a resonating component including a relatively thin, wide "ribbon-like" member through which fluid ejected from a flushing syringe passes. In the exemplary embodiment, the fluid flows around the resonating member rather than through it. In a non-limiting exemplary embodiment, fluid flowing over the surface of the ribbon-like member causes it to "flutter," alternately contacting opposing syringe tip walls (or other walls of the syringe body) and alternately closing off fluid flow on one side or the other of the member. In a non-limiting example, the operating mechanism resembles a feather flapping in a strong wind, or a reed vibrating in the sound of a wild animal or a wind instrument.

[0022] According to embodiments of the present disclosure, the resonating member is configured to avoid tearing or becoming severed so as not to block the fluid path of the catheter.

[0023] Exemplary embodiments of the present disclosure can provide a flexible member that will only resonate over a specific range of fluid velocities. An exemplary, non-limiting advantage is that it allows a clinician to depress the syringe plunger faster (e.g., with more force) or slower (e.g., with less force) to avoid a range of fluid velocities that will resonate and cause a pulsating flow, for example, if the clinician does not want to administer a pulsating flow to the catheter. [Brief explanation of the drawings]

[0024] Referring to the drawings, in which like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows. [Figure 1A] FIG. 1A shows an example of a cleaning syringe assembly. [Figure 1B] FIG. 1B shows an example of a cleaning syringe assembly. [Figure 2A] FIG. 2A shows various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2B] 2A and 2B show various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2C] 2A-2C show various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2D] 2A-2D show various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2E] 2E shows various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2F] 2F shows various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 2G] 2G shows various views of a syringe barrel including a cleaning mechanism and its various components, according to an exemplary embodiment of the present disclosure. [Figure 3A] 3A-3D show various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3B] 3A-3B show various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3C] 3A-3C show various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3D] 3A-3D show various views of a syringe barrel including a flushing mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3E] 3E shows various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3F] 3F shows various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 3G] 3G shows various views of a syringe barrel including a cleaning mechanism and its various components according to another exemplary embodiment of the present disclosure. [Figure 4A] 4A-4D show various views of a syringe barrel including a flushing mechanism and its various components, according to yet another exemplary embodiment of the present disclosure. [Figure 4B] 4A-4B show various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4C] 4A-4C show various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4D] 4A-4D show various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4E] 4E shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4F] 4F shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4G] 4G shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4H] 4H shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4I] FIG. 4I shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 4J] 4J shows various views of a syringe barrel including a cleaning mechanism and its various components according to yet another exemplary embodiment of the present disclosure. [Figure 5A]FIG. 5A shows a perspective view of a syringe barrel comprising a cleaning mechanism or combination of mechanisms according to an exemplary embodiment and / or embodiment of the present disclosure. [Figure 5B] FIG. 5B shows a perspective view of a ring, such as an O-ring, that may be utilized to secure a flushing mechanism, or combination of mechanisms, within a syringe barrel according to an exemplary embodiment and / or embodiments of the present disclosure. [Figure 6A] 6A-6D show various views of a syringe barrel including a flushing mechanism and its various components according to an alternative exemplary embodiment of the present disclosure. [Figure 6B] 6A and 6B show various views of a syringe barrel including a cleaning mechanism and its various components according to an alternative exemplary embodiment of the present disclosure. [Figure 6C] 6A-6C show various views of a syringe barrel including a flushing mechanism and its various components according to an alternative exemplary embodiment of the present disclosure. [Figure 6D] 6A-6D show various views of a syringe barrel including a flushing mechanism and its various components according to an alternative exemplary embodiment of the present disclosure. [Figure 7A] 7A-7D show various views of a syringe barrel including a flushing mechanism and its various components according to another alternative exemplary embodiment of the present disclosure. [Figure 7B] 7A and 7B show various views of a syringe barrel including a flushing mechanism and its various components according to another alternative exemplary embodiment of the present disclosure. [Figure 7C] 7A-7C show various views of a syringe barrel including a flushing mechanism and its various components according to another alternative exemplary embodiment of the present disclosure. [Figure 7D] 7A-7D show various views of a syringe barrel including a flushing mechanism and its various components according to another alternative exemplary embodiment of the present disclosure. [Figure 8A] FIG. 8A shows various views of a syringe barrel including a cleaning mechanism and its various components, according to yet another alternative exemplary embodiment of the present disclosure. [Figure 8B] 8A and 8B show various views of a syringe barrel including a flushing mechanism and its various components, according to yet another alternative exemplary embodiment of the present disclosure. [Figure 8C] 8A-8C show various views of a syringe barrel including a flushing mechanism and its various components in accordance with yet another alternative exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0025] DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS The matters exemplified herein are provided to facilitate a comprehensive understanding of the exemplary embodiments with reference to the accompanying drawings. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein may be made within the scope of the appended claims without departing from the full scope and equivalents thereof. Additionally, descriptions of well-known functions and structures have been omitted for clarity and conciseness. Similarly, specific naming conventions, labels, and terminology used in the context of this disclosure are non-limiting and are provided solely for illustrative purposes to facilitate understanding of the exemplary embodiments.

[0026] 2A-2G and 3A-3G, according to an exemplary embodiment of the present disclosure, a cleaning syringe 200 / 300 includes a cleaning mechanism 210 / 310 disposed within a syringe barrel 240. As shown in the exemplary embodiment of FIG. 5A, the syringe barrel 240 includes a sidewall 244 defining an essentially cylindrical chamber 245 with an open proximal end (not shown) and a distal end 241 having a syringe tip 242, wherein a plunger rod (not shown) disposed within the syringe barrel 240, when pushed toward the distal end 241 by, for example, a clinician, generates a flow of fluid within the chamber 245 toward the distal end 241 and out of the syringe tip 242.

[0027] In the exemplary embodiment, the cleaning mechanism 210 / 310 includes an orifice plate 230 / 330 disposed downstream or distal to the rotating wheel 220 / 320. Optionally, the orifice plate 230 / 330 can friction fit with the chamber 245. In the exemplary embodiment, the plate 230 / 330 includes a platen 232 / 332 having pins 238 / 338 extending therefrom about which the wheel 220 / 320 can rotate. In the exemplary embodiment, the platen 232 / 332 is essentially circular and has pins 238 / 338 extending essentially perpendicular thereto. Plate 230 / 330 further includes one or more orifices 236 / 336 in platen 232 / 332 (two orifices 236 in the example of FIGS. 2E-2G and three orifices 336 in the example of FIGS. 3E-3G), e.g., constituting exit orifices for fluid flowing from chamber 245 therethrough and out tip 242. Plate 230 / 330 can be positioned within chamber 245 proximate end 241 and can be rotatably and / or axially fixed within chamber 245, e.g., by platen 232 / 332, relative to the inner surface of sidewall 244 and / or the bottom portion of end 241.

[0028] In an exemplary embodiment, plate 230 / 330 includes a groove 234 / 334 on the outer periphery of platen 232 / 332 to accommodate a rubber, plastic, or other flexible or compressible O-ring, such as O-ring 500 illustrated in FIG. 5B , to facilitate a friction fit of plate 230 / 330 against the inner surface of sidewall 244. In an exemplary embodiment, plate 230 / 330 can be positioned within chamber 245 to facilitate a fluid-tight seal of plate 230 / 330 against the inner surface of sidewall 244. In an exemplary embodiment, the entire structure of plate 230 / 330 can be one piece, formed by, for example, injection molding.

[0029] In the exemplary embodiment, the wheel 220 / 320 includes a platen 222 / 322 having one or more angled vanes 224 / 324 (two vanes 224 in the example of FIGS. 2B-2D and three vanes 324 in the example of FIGS. 3B-3D ), e.g., at a non-90 degree angle relative to the platen 222 / 322, and a hub 228 / 328 extending therefrom. In the exemplary embodiment, the hub 228 / 328 is essentially centrally disposed on the platen 222 / 322 and extends substantially perpendicular thereto. The hub 228 / 328 and platen 222 / 322 have an essentially cylindrical opening 226 / 326 extending therethrough for receiving a pin 238 / 338. The platen 222 / 322 includes one or more openings, e.g., notches 229 / 329 (two openings 229 in the example of FIGS. 2B-2D, and three openings 329 in the example of FIGS. 3B-3D). In an exemplary embodiment, the entire structure of the wheel 220 / 320 may be one piece, formed, for example, by injection molding.

[0030] In further exemplary embodiments, the wheels 220 / 320 can be fixed relative to the plates 230 / 330, for example by snap-fitting pins 238 / 338 in the hubs 228 / 328, limiting axial movement of the wheels 220 / 230 relative to the plates 230 / 330 while allowing free rotational movement of the wheels 220 / 230 relative to the plates 230 / 330.

[0031] 2A-2G and 3A-3G, a pulsed flow is generated by the flow of fluid in the chamber 245, and a wheel 220 / 320 having vanes 224 / 324 disposed in the flowing fluid rotates relative to the plate 220 / 320 such that a rotational velocity component in the fluid can be induced by the tilted vanes 224 / 324. In an exemplary embodiment, the configuration of the tilted vanes 224 / 324 on the wheel 220 / 320 can be similar to that of a turbine or pinwheel. The rotating wheel 220 / 320 can have one or more openings 229 / 239 that alternately cover and uncover outlet orifices 236 / 336 in a plate 230 / 330 downstream of the wheel 220 / 320, e.g., starting and stopping fluid flow at each outlet orifice 236 / 336 to provide a pulsed flow through the syringe tip 242.

[0032] 4A-4J, according to an exemplary embodiment of the present disclosure, a cleaning syringe 400 includes a cleaning mechanism 410 disposed within the syringe barrel 240. In the exemplary embodiment, the cleaning mechanism 410 includes an orifice plate 430 disposed downstream or distal of a rotating wheel 420, which is disposed downstream or distal of a stationary plate 440.

[0033] In the exemplary embodiment, plate 430 includes a platen 432 having a pin 438 extending therefrom, around which wheel 420 can rotate. In the exemplary embodiment, platen 432 is essentially circular and has a pin 438 extending essentially perpendicular thereto. Plate 430 further defines one or more orifices 436, e.g., exit orifices, in platen 432 through which fluid flows from chamber 245 out tip 242. Plate 430 can be positioned within chamber 245 proximate tip 241 and can be rotatably and / or axially fixed within chamber 245, e.g., by platen 432, with respect to the inner surface of sidewall 244 and / or the bottom of tip 241, permanently and / or removably secured thereto, e.g., by platen 432. In the exemplary embodiment, the entire structure of plate 430 can be one piece, formed, for example, by injection molding.

[0034] In the exemplary embodiment, wheel 420 includes a platen 422 having one or more non-angled vanes 424, which may be essentially perpendicular to the platen 422, and a hub 428 extending therefrom. In the exemplary embodiment, hub 428 is essentially centrally located on platen 422 and extends essentially perpendicular thereto. Hub 428 and platen 422 have a substantially cylindrical opening 426 extending therefrom for receiving pin 438. Platen 422 includes one or more openings, e.g., notches 429. In the exemplary embodiment, the entire structure of wheel 420 may be one piece, formed, for example, by injection molding.

[0035] In the exemplary embodiment, plate 440 includes a platen 442 having pins 448 extending therefrom. In the exemplary embodiment, pins 438 of plate 430 include hollow cylindrical openings 437 for receiving pins 448. In the exemplary embodiment, platen 442 is essentially circular and has pins 448 extending essentially perpendicular thereto. Plate 440 further includes one or more orifices 446 in platen 442 having sloping walls 447, such as exit orifices, through which fluid flows from chamber 245 to impinge on one or more vanes 424 at a non-zero angle. In the exemplary embodiment, plate 440 can be rotatably and / or axially fixed, permanently and / or removably, within chamber 245 with respect to the inner surface of sidewall 244 and / or the bottom portion of end 241, e.g., by platen 442, instead of or similar to plate 430. In the exemplary embodiment, the entire structure of plate 440 can be one piece, formed, for example, by injection molding.

[0036] In an exemplary embodiment, plates 430 and / or 440 may include a groove (not shown, see illustrations in FIGS. 2E-2G and 3E-3G ) on the outer periphery of platen 442 to accommodate a rubber, plastic, or other flexible or compressible O-ring, such as O-ring 500 depicted in FIG. 5B , to facilitate a friction fit of plates 430 and / or 440 against the inner surface of sidewall 244. In an exemplary embodiment, plates 430 and / or 440 may be disposed within chamber 245 to facilitate a fluid-tight seal of plates 430 and / or 440 against inner sidewall 234.

[0037] In a further exemplary embodiment, wheel 420 can be secured between plates 420 and 440, for example by a snap fit of pin 448 within hollow pin 438, limiting axial movement of wheel 420 relative to plates 430 and / or 440 while allowing free rotational movement of wheel 420 relative to plates 430 and 440.

[0038] 4A-4J , a pulsed flow can be generated by fluid flowing in chamber 245 through orifice 446, causing a rotational velocity component in the fluid to be induced by tilt 447, causing wheel 420 having vanes 424 positioned in the fluid flowing through orifice 446 to rotate relative to plate 420. Rotating wheel 420 includes one or more openings 429 that alternately cover and uncover exit orifices 436 in plate 430 downstream of wheel 420, e.g., causing fluid flow to start and stop at each exit orifice 436, resulting in a pulsed flow through syringe tip 242.

[0039] An exemplary embodiment of the present disclosure with lower manufacturing costs can provide a wheel with angled blades (turbine) manufactured by molding. As described herein, the use of a wheel with angled blades can reduce the total number of parts required to generate the pulsed flow to one rotating wheel / turbine downstream of the wheel and one orifice plate, which includes pins about which the wheel can rotate, as shown, for example, in Figures 2A-2G and 3A-3G.

[0040] Exemplary embodiments of the present disclosure can be configured to have the lowest "stack height" of the pulsed flow mechanism, minimize the additional size and material of the wash syringe, minimize the volume of fluid remaining in the syringe so that it is not injected when the plunger reaches the pulsed flow mechanism, and can position the pulsed flow mechanism 210, 310, 410 at the distal end of the syringe barrel proximate to the syringe tip 242, as illustrated, for example, in FIGS. 2A-2G, 3A-3G, and 4A-4J.

[0041] In an exemplary embodiment, a rotational flow may be induced in the fluid before it exits the tip of the wash syringe. In a further exemplary embodiment, the rotational component of the fluid flow may continue until it reaches the IV catheter, and this rotational component of the fluid flow may help wash blood or other undesirable fluids from areas within the catheter fluid path that are difficult to clean with a constant, non-rotating flow (e.g., sharp interior corners, etc.).

[0042] An alternative embodiment of the present disclosure that uses fluid momentum to generate a pulsed flow utilizes a resonating (flapping, fluttering) flexible valve, which can flutter or resonate over a range of fluid velocities.

[0043] 6A-6D , an exemplary alternative embodiment of the present disclosure provides a syringe 600 having a resonant irrigation component 610 comprising a flapper, e.g., a nominally closed, relatively thin, wide tube 612, disposed on a flapper support structure 616, at the distal end 241 of the syringe barrel 240. As shown in more detail, the syringe tip 242 includes a tip 243 within a luer lock collar 247. Fluid 650 expelled from the barrel 240 of the irrigation syringe 600 by a moving plunger (not shown) flows into a narrow slit 614 in the flapper 612, passes through the flapper 612, and passes through 652, causing the walls of the flapper 612 to alternately open and close against each other in a “flapping” manner. For example, low pressure from fluid velocity causes the flapper walls to move toward each other, closing the slit 614. In an exemplary embodiment, the resonance of the walls of the thin-walled tube relative to one another creates a pulsed flow 654 that exits the syringe 600 at its tip 243. In a non-limiting example, the component 610 can be fabricated as a single component and axially and rotationally secured at its distal end 241 within the chamber 245 of the barrel 240 such that at least a portion of the flapper 612 extends into the tip 243 of the syringe 600.

[0044] 7A-7D , another exemplary alternative embodiment of the present disclosure provides a syringe 700 having a resonant cleaning component 710 at the distal end 241 of the syringe barrel 240, the resonant cleaning component 710 comprising a long, thin tube 712 having an opening 714 disposed on a tube support structure 716. Fluid 750 expelled from the barrel 240 of the cleaning syringe 700 by a moving plunger (not shown) enters the opening 714 of the tube 712 and flows 752 through the tube 712. In the exemplary embodiment, at least a portion, or all, of the tube 712 becomes whipped due to the exit velocity of the fluid at the tip of the tube 712. For example, the fluid exiting the tip of the tube 712 creates a compressive rebound force on the tube 712, causing the tube 712 to become unstable under the compressive rebound force 752, causing it to periodically kink and “whip,” creating a pulsating flow 754. In a non-limiting example, component 710 can be manufactured as a single component and axially and rotationally fixed at its distal end 241 within chamber 245 of barrel 240, with at least a portion of tube 712 extending into tip 243 of syringe 700.

[0045] 8A-8C , yet another exemplary alternative embodiment of the present disclosure provides a syringe 800 having a resonant cleaning component 810 at the distal end 241 of the syringe barrel 240, the resonant cleaning component 810 comprising a relatively thin, wide “ribbon-like” member 812 disposed on a ribbon support structure 816 at a retaining portion 814. Fluid expelled from the barrel 240 of the cleaning syringe 800 by a moving plunger (not shown) flows 850 through an opening 818 in the support structure 816 and over 852 the ribbon 812. In the exemplary embodiment, the fluid flows around the resonant member rather than through it. In a non-limiting exemplary embodiment, the fluid flowing 852 over the surface of the ribbon-like member 812 causes the ribbon 812 to flutter or sway, periodically interrupting the flow through the syringe tip and creating a pulsed flow 842, due to fluid-structure interactions between the vortex flow and the undulating shape of the ribbon 812. For example, fluttering or flailing of ribbon 812 alternately closes off fluid flow on one side or the other of ribbon 812 such that ribbon 812 alternately contacts opposing interior walls of syringe tip 243 (or other walls of the syringe body, e.g., within distal portion 241 of chamber 245). In a non-limiting example, component 810 can be fabricated as a single component and axially and rotationally secured, e.g., by a friction fit, at its distal end 241 within chamber 245 of barrel 240, such that at least a portion of ribbon 812 extends into tip 243 of syringe 800.

[0046] Although the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Furthermore, any of the features or elements of any exemplary embodiment of the embodiments of the present disclosure as described above may be implemented individually or in any combination, as would be readily apparent to a skilled artisan, without departing from the spirit and scope of the embodiments of the present disclosure.

[0047] Additionally, the accompanying drawings further illustrate non-limiting examples of certain exemplary embodiments of the present disclosure and aid in explaining the technology associated therewith. Any specific or relative dimensions or measurements provided in the above-described drawings and elsewhere are exemplary and are not intended to limit the scope or content of the inventive designs or methods as would be understood by one skilled in the relevant art(s) of the disclosure.

[0048] Other objects, advantages and salient features of the present disclosure will become apparent to those skilled in the art from the details provided in conjunction with the accompanying drawing figures, which disclose illustrative embodiments of the present disclosure.

Claims

1. 1. A cleaning syringe comprising: a barrel having a sidewall extending from a proximal end to a distal end and defining a chamber for containing a fluid; a syringe tip disposed at the distal end of the barrel, the fluid exiting the barrel through the syringe tip; and a resonating flexible member disposed in the fluid flow; the resonating flexible member comprises a flat tube having a wall with an internal slit and positioned at least partially within the syringe tip; A washing syringe wherein the flow of fluid through the internal slit causes the walls to resonate with each other creating a pulsed flow in the fluid flow from the chamber through the resonating flexible member and out the syringe tip.

2. 1. A cleaning syringe comprising: a barrel having a sidewall extending from a proximal end to a distal end and defining a chamber for containing a fluid; a syringe tip disposed at the distal end of the barrel, the fluid exiting the barrel through the syringe tip; and a resonating flexible member disposed in the fluid flow; the resonating flexible member comprises a hollow tube at least partially disposed within the syringe tip; A washing syringe wherein the fluid flow through the hollow tube causes a compressive rebound force on the hollow tube, causing the hollow tube to become unstable and periodically kink, producing pulses in the fluid flow from the chamber, through the resonating flexible member, and out the syringe tip.

3. 1. A cleaning syringe comprising: a barrel having a sidewall extending from a proximal end to a distal end and defining a chamber for containing a fluid; a syringe tip disposed at the distal end of the barrel, the fluid exiting the barrel through the syringe tip; and a resonating flexible member disposed in the fluid flow; the resonating flexible member: a ribbon at least partially disposed within the syringe tip; and a support structure that directs the fluid flow from the chamber onto the ribbon; the flow of fluid passing over the ribbon causes the ribbon to periodically disrupt flow through the syringe tip, creating pulses in the flow of fluid from the chamber, through the resonating flexible member, and exiting the syringe tip; A washing syringe, wherein the ribbon and the support structure are integrally formed.

4. The washing syringe of claim 3 , wherein the support structure includes at least one opening for the flow of the fluid.

5. The washing syringe of claim 3 , wherein the support structure is axially and rotationally fixed within the barrel.

6. 3. The washing syringe of claim 1, wherein the resonating flexible member is axially and rotationally fixed within the barrel.

Citation Information

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