Means for disinfection detection and device differentiation in intravenous administration systems via force sensitive resistors

Abstract

A connector for an intravenous administration system includes: a housing; a body at least partially disposed within the housing and defining a longitudinal axis and an interior cavity; a first fitting located at the first end of the body; a second fitting located at the second end of the body; the flexible sealing element is arranged in the first accessory, and the flexible sealing element is used for preventing pollution in the first accessory; and the scrubbing sensor is arranged on the body. The body is movable relative to the housing. The scrubbing sensor includes one or more force sensing elements configured to engage with the housing as the body moves relative to the housing. The one or more force sensing elements are configured to emit an electrical signal upon contact with the housing.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 426,490, filed on Nov. 18, 2022, entitled "Means of Disinfection Detection and Device Differentiation in an Intravenous Administration System via Force Sensitive Resistors", the entire disclosure of which is incorporated herein by reference.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present disclosure relates to a connector for an intravenous drug administration system, and more particularly, to a connector having a sensor for detecting disinfection of the connector.

[0006] Description of the Related Art

[0007] Catheter-related bloodstream infections are caused by bacteria / fungi in a patient's body when using an intravascular catheter. These infections are an important cause of disease and excessive medical costs. Various guidelines and regulations prescribe practices for limiting catheter-related bloodstream infections in hospital, outpatient, and home care settings. These guidelines and regulations address issues such as clinician hand hygiene, catheter site care, admixture preparation, and connector cleaning. Despite these guidelines, catheter-related blood infections continue to plague our healthcare system.

[0008] Scrubbing of the connector is an important part of infection prevention, but proper scrubbing can be difficult to quantify and verify. Since scrubbing is performed manually by a clinician, the cleanliness of the connector is prone to inconsistency, and in the worst case, insufficient cleaning puts the patient at risk of infection. Therefore, there is a need for a connector that includes features for verifying that adequate scrubbing has been performed to mitigate the risk of blood infection due to connector contamination. Summary of the Invention

[0009] According to an embodiment of the present invention, a connector for an intravenous administration system includes: a housing; a body that is at least partially disposed within the housing and defines a longitudinal axis and a lumen; a first fitting located at a first end of the body; a second fitting located at a second end of the body; a flexible seal disposed in the first fitting for preventing contamination in the first fitting; and a scrubbing sensor disposed on the body. The body is movable relative to the housing, and the scrubbing sensor includes one or more force sensing elements configured to engage the housing when the body moves relative to the housing, and wherein the one or more force sensing elements are configured to emit an electrical signal upon contact with the housing.

[0010] According to an embodiment of the present invention, the one or more force sensing elements include at least one of a force sensitive resistor, a piezoelectric film, and / or a membrane switch.

[0011] According to an embodiment of the present invention, the scrubbing sensor includes a flexible substrate, and the one or more force sensing elements are disposed on the flexible substrate.

[0012] According to an embodiment of the present invention, the housing includes one or more ribs that are aligned with the one or more force sensing elements.

[0013] According to an embodiment of the present invention, the flexible substrate is contoured around the body such that two of the at least one force sensing elements are radially positioned opposite each other on the body.

[0014] According to an embodiment of the present invention, the flexible substrate is engaged with an electrical module for receiving the electrical signal emitted by the one or more force sensing elements.

[0015] According to an embodiment of the present invention, the housing includes a sealing cap having one or more contact pads that are aligned with at least one of the one or more force sensing elements.

[0016] According to an embodiment of the present invention, the one or more contact pads are configured to engage a disposable item connected to the first fitting.

[0017] According to an embodiment of the present invention, the one or more contact pads completely surround an orifice of the sealing cap, and the first fitting extends through the orifice.

[0018] According to an embodiment of the present invention, the one or more force sensing elements aligned with the one or more contact pads face substantially forward toward the first fitting.

[0019] According to an embodiment of the present invention, the connector further includes an electrical module configured to determine that a scrubbing procedure has been performed based on an electrical signal emitted by the one or more force sensing elements.

[0020] According to an embodiment of the present invention, the connector further includes an electrical module configured to determine that a disposable item is connected to the first fitting based on an electrical signal emitted by the one or more force sensing elements.

[0021] According to an embodiment of the present invention, the electrical module is configured to determine the type of the disposable item connected to the first fitting based on an electrical signal emitted by the one or more force sensing elements.

[0022] According to an embodiment of the present invention, the electrical signal emitted by the one or more force sensing elements is a binary signal, such as at least one of a digital signal and an analog signal.

[0023] According to an embodiment of the present invention, the electrical signal emitted by the one or more force sensing elements is at least one of a transient signal and a static signal.

[0024] According to an embodiment of the present invention, the one or more force sensing elements include at least two force sensing elements having different sensitivities.

[0025] According to an embodiment of the present invention, the housing is pivotally connected to the body.

[0026] According to an embodiment of the present invention, the body is at least partially floating in the housing.

[0027] According to an embodiment of the present invention, the one or more force sensing elements are arranged to engage with the housing in response to a lateral force acting perpendicular to the longitudinal axis.

[0028] According to an embodiment of the present invention, the one or more force sensing elements are arranged to engage with the housing in response to a torsional force acting about the longitudinal axis.

[0029] Further details and advantages of the various examples described in detail herein will become apparent after the following detailed description of the various examples in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The above and other features, advantages, and ways of achieving these features and advantages of the present disclosure will become more apparent and the present disclosure itself will be better understood by referring to the following description of embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0031] Figure 1 is a perspective view of a connector according to an embodiment of the present disclosure;

[0032] Figure 2 is Figure 1 A perspective view of the connector, with its housing not shown;

[0033] Figure 3 is Figure 1 A perspective view of the scrubbing sensor of the connector;

[0034] Figure 4 is the top view of the scrubbing sensor of Figure 3 in a preformed state;

[0035] Figure 5 is Figure 1 A perspective view of the housing of the connector;

[0036] Figure 6 is Figure 1 A cross-sectional view of the connector;

[0037] Figure 7 is Figure 1 A perspective view of the sealing cap of the connector;

[0038] Figure 8 is a perspective view of the connector according to an embodiment of the present disclosure, with its housing not shown;

[0039] Figure 9 is in a preformed state Figure 8 A perspective view of the scrubbing sensor of the connector;

[0040] Figure 10 is Figure 8 A perspective view of the sealing cap of the connector;

[0041] Figure 11 is Figure 8 A cross-sectional view of the connector; and

[0042] Figure 12 is a schematic diagram of the connector connected to a disposable article Figure 1 or Figure 8 .

[0043] In all of the several views, corresponding reference numerals denote corresponding parts. The examples presented herein illustrate exemplary embodiments of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any way. Detailed Description

[0044] The following description is provided to enable those skilled in the art to make and use the various aspects contemplated for implementing the present disclosure. However, various modifications, equivalents, variations, and alternatives will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0045] In the following, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that unless there is a clear indication to the contrary, the present invention can adopt various alternative variations. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary aspects of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered restrictive.

[0046] All numbers used in the specification and claims should be understood to be modified in all cases by the term "about". The terms "approximate", "about" and "substantially" mean a range of plus or minus ten percent of the recited value. In addition, the terms "substantially equal" and similar terms mean that the compared values or dimensions are within plus or minus ten percent of each other.

[0047] The terms "first", "second", etc. are not intended to refer to any particular order or sequence, but rather to different conditions, properties, or elements.

[0048] With respect to an injection device (such as a syringe), the term "proximal" as used herein refers to the end of the device that is farthest from the outlet, or to the direction towards the end of the device that is farthest from the outlet. With respect to an injection device (such as a syringe), the term "distal" as used herein refers to the end of the device that is closest to the outlet, or to the direction towards the end of the device that is closest to the outlet.

[0049] As used herein, "at least one of..." is synonymous with "one or more of...". For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of only A; or one or more of only B; or one or more of only C; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of A, one or more of B, and one or more of C.

[0050] First, refer to Figures 1 to 7 ,Figures 1 to 7 An example of a needleless connector (hereinafter referred to as "connector 100") according to the present disclosure is shown. Generally, connector 100 includes a body 102 that has a first fitting (i.e., a female Luer fitting 110) at one end and a second fitting (i.e., a male Luer fitting 120) at the opposite end. A lumen extends through body 102 of connector 100 between female Luer fitting 110 and male Luer fitting 120 to facilitate fluid flow through connector 100. Body 102 of connector 100 may be generally cylindrical in shape, defining a longitudinal axis 104. A flexible seal 112 is disposed in female Luer fitting 110 and prevents contamination of the lumen by sealing female Luer fitting 110. Female Luer fitting 110 is configured to receive a complementary male Luer fitting of a component (e.g., a disposable item such as a syringe 400, see Figure 12 ). When connected, the complementary male Luer fitting presses seal 112 into the lumen, thereby opening at least one passage through the lumen to allow fluid to flow through connector 100.

[0051] Body 102 of connector 100 is at least partially disposed within a housing 130 that includes a sealing cap 132. Housing 130 encloses a scrub sensor 200 and an associated electrical module 300. Figure 2 An illustration shows housing 130 and sealing cap 132 removed from connector 100 so that the underlying components of connector 100 can be seen. Body 102 is mounted within housing 130 in a manner that allows relative movement between body 102 and housing 130. In some embodiments, body 102 may be connected to housing 130 at a pivot point. In some embodiments, body 102 is at least partially floating within housing 130. In some embodiments, foam or other resilient material may be located between body 102 and housing 130 to allow relative movement.

[0052] Still referring to Figures 1 to 7 , to ensure a sterile connection between female Luer fitting 110 and a connecting component (e.g., a disposable item such as a syringe 400, see Figure 12 ), seal 112 is disinfected prior to being connected to the connecting component. To disinfect seal 112, a clinician typically grasps housing 130 of connector 100 and / or male Luer fitting 120 and scrubs seal 112 with a wipe pad that includes isopropyl alcohol or other suitable disinfectant. Because the scrubbing is performed manually by the clinician, the cleanliness and sterility of seal 112 can be inconsistent if relying solely on the clinician's skill and experience. To eliminate this inconsistency and ensure sufficient scrubbing is performed, scrub sensor 200 verifies that sufficient force, pressure, intensity, and / or scrub duration has been applied during the scrubbing process.

[0053] The scrubbing sensor 200 includes at least one force sensing element (e.g., a Force Sensitive Resistor (FSR), a force sensitive film (e.g., a piezoelectric PVDF film), a membrane switch, etc.) having an optional separate activation area, and the at least one force sensing element is configured to output an electrical signal in response to an applied force or pressure. In Figures 1 to 7 the illustrated embodiment, the scrubbing sensor 200 includes a flexible substrate 210 having sensors including separate areas. For example, one sensor can be divided into multiple segments, such as five FSRs 212a, 212b, 212c, 212d, and 212e are provided. Each of the FSRs 212a to 212e is positioned to detect forces applied at different positions and / or orientations relative to the connector 100. Each of the FSRs 212a to 212e transmits an electrical signal to the electrical module 300 via a header 214 (e.g., a zero insertion force header, a soldered joint, etc.) that is in electrical communication with the electrical module 300. The scrubbing sensor 200 can be manufactured as a flat component, as Figure 4 shown, and then formed (e.g., folded and / or rolled up) into Figure 3 the profile shown in. In particular, the portions of the substrate 210 including the FSRs 212a, 212c are formed around the perimeter of the body 102 such that the FSRs 212a, 212c are positioned radially opposite each other on the body 102. The FSRs 212d, 212e are provided on the front flap 211 of the substrate 210, and the front flap 211 is folded such that the FSRs 212d, 212e face substantially forward toward the female luer fitting 110. The header 214 of the substrate 210 is positioned to physically and electrically engage the electrical module 300.

[0054] Continuing to refer to Figure 5 and Figure 6 , the housing 130 includes one or more internal side ribs 140 aligned with the FSRs 212a, 212c. When the body 102 moves laterally relative to the housing 130, causing the FSR 212a to contact the associated rib 140, the FSR 212a emits an electrical signal indicating the applied force / pressure. Similarly, when the body 102 moves in the opposite direction such that the FSR 212c contacts the associated rib 140, the FSR 212c emits an electrical signal indicating the applied force / pressure. The housing 130 also includes an internal top rib 142 aligned with the FSR 212b. When the body 102 moves vertically relative to the housing 130, causing the FSR 212b to contact the corresponding rib 142, the FSR 212b emits an electrical signal indicating the applied force / pressure.

[0055] The electrical signals emitted by the FSRs 212a, 212b, 212c can be processed by the electrical module 300 (or can be transmitted by the electrical module 300 to an external processor) to verify that the required force, pressure, and / or duration has been applied during the scrubbing process. In particular, the FSRs 212a, 212b, 212c emit signals in response to movement of the body 102 within the housing 130, which signals indicate that a scrubbing motion is being applied to the female luer fitting 110 when the clinician grasps the connector 100 through the housing 130 and / or the male luer fitting 120. The FSRs 212a, 212b, 212c and the corresponding ribs 140, 142 can be arranged to engage with each other in response to one or both of the following: (i) a lateral force acting perpendicular to the longitudinal axis 104 (corresponding to a side-to-side scrubbing motion on the surface of the seal 112), and (ii) a torsional force acting about the longitudinal axis 104 (corresponding to a circular scrubbing motion). Based on the amplitude and / or duration of the signals emitted by one or more of the FSRs 212a, 212b, 212c, the electrical module 300 (or the external processor) can determine whether sufficient scrubbing has been performed to ensure that the seal 112 is disinfected.

[0056] Referring now Figure 7 , the sealing cap 132 can include a lip 134 that is connected to a corresponding lip 138 of the housing 130 (see Figure 5 and Figure 6 ). The sealing cap 132 also includes one or more contact pads 136 that are aligned with the FSRs 212d, 212e (see Figure 3 and Figure 4 ). Thus, the force and / or pressure applied to the contact pads 136 is transmitted to the corresponding FSRs 212d, 212e, causing the FSRs 212d, 212e to emit electrical signals indicative of the applied force / pressure. The electrical signals emitted by the FSRs 212e, 212f can be processed by the electrical module 300 (or can be transmitted by the electrical module 300 to an external processor) to detect the connection of certain disposable articles 400 to the female luer fitting 110 (see Figure 12 ). That is, certain disposable articles 400 can have a structure that is configured to engage the contact pads 136 of the sealing cap 132 when the disposable article 400 is connected to the female luer fitting 110, thereby applying a force / pressure to the FSRs 212e, 212f.

[0057] Based on the electrical signals emitted by FSRs 212e, 212f, the electrical module 300 can detect the presence of the disposable item 400 connected to the female luer fitting 110. Additionally, based on the electrical signals emitted by FSRs 212e, 212f, the electrical module 300 can verify that the disposable item 400 is fully in place by determining that the force exerted by the disposable item 400 on the contact pad 136 meets or exceeds a known and / or predetermined connection force. The known and / or predetermined connection force may be different for different types of disposable items 400. Thus, based on the electrical signals emitted by FSRs 212e, 212f, the electrical module 300 can detect the type of the disposable item 400 connected to the female luer fitting 110.

[0058] Referring now to Figures 8 to 11 , another embodiment of the connector 100 is substantially similar to the embodiment of Figures 1 to 7 , where like reference numerals represent identical or functionally equivalent components. The differences between the embodiments include Figures 8 to 11 's sealing cap 133, which is functionally similar to Figures 1 to 7 's sealing cap 132, is mounted substantially within the housing 130, and the sealing cap 133 includes a continuous contact pad 137 that completely surrounds the orifice 139 through which the female luer fitting 110 extends. The contact pad 137 aligns with certain FSRs of the scrub sensor 200 in the same manner as Figures 1 to 7 's contact pad 136. In particular, the flaps 211 of the flexible substrate 210 of the scrub sensor 200 completely surround the female luer fitting 110 and include three FSRs 212f, 212g, 212h. The force and / or pressure applied to the contact pad 137 is transmitted to the FSRs 212f, 212g, 212h, causing the FSRs 212f, 212g, 212h to emit electrical signals indicative of the applied force / pressure. The FSRs 212f, 212g, 212h can be used to detect the connection of the disposable item (e.g., syringe 400, see Figure 12 ) to the female luer fitting 110 based on the force / pressure applied by the disposable item 400 to the contact pad 137. Additionally, the electrical module 300 can be configured to verify the connection of the disposable item 400 and determine the type of the connected disposable item 400 in a manner substantially the same as that discussed in connection with Figures 1 to 7 .

[0059] While Figures 1 to 11The illustrated embodiment of the scrub sensor 200 utilizes FSRs 212a through 212h to detect force and / or pressure, but the FSRs can be replaced with alternative force sensing elements (e.g., piezoelectric elements, membrane switches, etc.). The sensitivity of the scrub sensor 200 can be mechanically and / or electrically configured as needed to provide a binary signal (e.g., one of a digital signal and an analog signal, or at least one of a transient signal and a static signal output) to balance the competing goals of sensor resolution and computational overhead. Additionally, each of the FSRs 212a through 212h (or alternative force sensing elements) can be individually configured to a desired sensitivity.

[0060] Although, for the purposes of illustration, the invention has been described in detail based on presently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A connector for an intravenous administration system, the connector comprising: a housing; a body that is at least partially disposed within the housing and defines a longitudinal axis and a lumen; a first fitting located at a first end of the body; a second fitting located at a second end of the body; a flexible seal disposed in the first fitting for preventing contamination in the first fitting; and a scrub sensor disposed on the body; wherein the body is movable relative to the housing, wherein the scrub sensor includes one or more force sensing elements configured to engage the housing when the body moves relative to the housing, and wherein the one or more force sensing elements are configured to emit an electrical signal when contacting the housing.

2. The connector according to claim 1, wherein, The one or more force sensing elements include at least one of a force sensitive resistor, a piezoelectric film, and a membrane switch.

3. The connector according to claim 1, wherein The scrub sensor includes a flexible substrate on which the one or more force sensing elements are disposed.

4. The connector according to claim 1, wherein, The housing includes one or more ribs that are aligned with the one or more force sensing elements.

5. The connector according to claim 3, wherein, The flexible substrate is shaped around the body such that two of the at least one force sensing elements are positioned on the body relative to each other.

6. The connector according to claim 1, wherein The flexible substrate is engaged with an electrical module configured to receive the electrical signal emitted by the one or more force sensing elements.

7. The connector according to claim 1, wherein, The housing includes a sealing cap having one or more contact pads that are aligned with at least one of the one or more force sensing elements.

8. The connector according to claim 7, wherein, The one or more contact pads are configured to engage a disposable item connected to the first fitting.

9. The connector according to claim 7, wherein, The one or more contact pads completely surround an orifice of the sealing cap through which the first fitting extends.

10. The connector according to claim 7, wherein, The one or more force sensing elements aligned with the one or more contact pads face substantially forward toward the first fitting.

11. The connector according to claim 1, the connector further comprising an electrical module configured to determine that a scrubbing procedure has been performed based on the electrical signal emitted by the one or more force sensing elements.

12. The connector according to claim 1, the connector further comprising an electrical module configured to determine that a disposable item is connected to the first fitting based on the electrical signal emitted by the one or more force sensing elements.

13. The connector according to claim 12, wherein, The electrical module is configured to determine the type of the disposable item connected to the first fitting based on the electrical signal emitted by the one or more force sensing elements.

14. The connector according to claim 1, wherein, The electrical signal emitted by the one or more force sensing elements is a binary signal, such as at least one of a digital signal and an analog signal.

15. The connector according to claim 1, wherein, The electrical signal emitted by the one or more force sensing elements is at least one of a transient signal and a static signal.

16. The connector according to claim 1, wherein, The one or more force sensing elements include at least two force sensing elements having different sensitivities.

17. The connector according to claim 1, wherein, The housing is pivotally connected to the body.

18. The connector according to claim 1, wherein, The body is at least partially floating in the housing.

19. The connector according to claim 1, wherein, The one or more force sensing elements are arranged to engage with the housing in response to a lateral force acting perpendicular to the longitudinal axis.

20. The connector according to claim 1, wherein, The one or more force sensing elements are arranged to engage with the housing in response to a torsional force acting about the longitudinal axis.

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