Means of disinfection detecton and device differentiation in an intravenous administration system via force sensitive resistors

Abstract

A connector for an intravenous administration system includes a housing, a body at least partially disposed in the housing and defining a longitudinal axis and a lumen, a first fitting at a first end of the body, a second fitting 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. The scrubbing sensor includes one or more force sensing elements configured to engage the housing when the body moves relative to the housing. The one or more force sensing elements are configured to emit an electrical signal when contacting the housing.

Description

MEANS OF DISINFECTION DETECTON AND DEVICE DIFFERENTIATION IN AN INTRAVENOUS ADMINISTRATION SYSTEM VIA FORCE SENSITIVE RESISTORSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application No. 63 / 426,490 entitled “Means of Disinfection Detection and Device Differentiation in an Intravenous Administration System via Force Sensitive Resistors” filed November 18, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates to a connector for an intravenous medication administration system, and, more particularly, to a connector having a sensor for detecting disinfection of the connector.Description of Related Art

[0003] Catheter-related bloodstream infections are caused by bacteria / fungi in patients with intravascular catheters. These infections are a significant cause of illness and excess medical costs. Various guidelines and regulations prescribe practices to limit catheter-related bloodstream infections in hospital, outpatient, and home care settings. These guidelines and regulations address issues such clinician hand hygiene, catheter site care, admixture preparation, and connector cleanliness. Despite these guidelines, catheter-related bloodstream infections continue to plague our healthcare system.

[0004] Scrubbing of connectors is an important component of infection prevention, but proper scrubbing can be difficult to quantify and verify. As scrubbing is performed manually by the clinician, the resulting cleanliness of connectors is susceptible to inconsistency, and, in the worst case, inadequacy that places the patient at risk for infection. Therefore, a need exists for connectors which include features for validating that sufficient scrubbing has been performed to mitigate the risk of blood infection from connector contamination.SUMMARY OF THE INVENTION

[0005] In accordance with an embodiment of the present invention, a connector for an intravenous administration system includes a housing, a body at least partially disposed in the housing and defining a longitudinal axis and a lumen, a first fitting at a first end of the body, asecond fitting 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, wherein 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 when contacting the housing.

[0006] In accordance with 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.

[0007] In accordance with an embodiment of the present invention, the scrubbing sensor includes a flexible substrate on which the one or more force sensing elements are disposed.

[0008] In accordance with an embodiment of the present invention, the housing includes one or more ribs aligned with the one or more force sensing elements.

[0009] In accordance with 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 positioned diametrically opposite one another on the body.

[0010] In accordance with an embodiment of the present invention, the flexible substrate engages an electrical module for receiving the electrical signals emitted by the one or more force sensing elements.

[0011] In accordance with an embodiment of the present invention, the housing includes a seal cap having one or more contact pads aligned with at least one of the one or more force sensing elements.

[0012] In accordance with an embodiment of the present invention, the one or more contact pads are configured to engage a disposable connected to the first fitting.

[0013] In accordance with an embodiment of the present invention, the one or more contact pads entirely surround an orifice of the seal cap through which the first fitting extends.

[0014] In accordance with 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.

[0015] In accordance with an embodiment of the present invention, the connector further includes an electrical module configured to determine, based on the electrical signal emitted by the one or more force sensing elements, that a scrubbing procedure has been performed.

[0016] In accordance with an embodiment of the present invention, the connector further includes an electrical module configured to determine, based on the electrical signal emitted by the one or more force sensing elements, that a disposable is connected to the first fitting.

[0017] In accordance with an embodiment of the present invention, the electrical module is configured to determine, based on the electrical signal emitted by the one or more force sensing elements, a type of the disposable is connected to the first fitting.

[0018] In accordance with an embodiment of the present invention, the electrical signal emitted by the one or more force sensing elements is a binary signal, such as one of a digital signal and an analog signal.

[0019] In accordance with an embodiment of the present invention, the electrical signal emitted by the one or more force sensing elements is one of a transient signal and a static signal.

[0020] In accordance with an embodiment of the present invention, the one or more force sensing elements includes at least two force sensing elements having different sensitivities.

[0021] In accordance with an embodiment of the present invention, the housing is pivotally connected to the body.

[0022] In accordance with an embodiment of the present invention, the body at least partially floats in the housing.

[0023] In accordance with an embodiment of the present invention, the one or more force sensing elements are arranged to engage the housing in response to a lateral force acting perpendicular to the longitudinal axis.

[0024] In accordance with an embodiment of the present invention, the one or more force sensing elements are arranged to engage the housing in response to a torsional force acting about the longitudinal axis.

[0025] Further details and advantages of the various examples described in detail herein will become clear upon reviewing the following detailed description of the various examples in conjunction with the accompanying drawing figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0027] FIG. 1 is a perspective view of a connector according to an embodiment of the present disclosure;

[0028] FIG. 2 is a perspective view of the connector of FIG. 1, with a housing thereof not shown;

[0029] FIG. 3 is a perspective view of a scrubbing sensor of the connector of FIG. 1 ;

[0030] FIG. 4 is a top view of the scrubbing sensor of FIG. 3 in a pre-shaped state;

[0031] FIG. 5 is a perspective view of the housing of the connector of FIG. 1;

[0032] FIG. 6 is a cross-sectional view of the connector of FIG. 1;

[0033] FIG. 7 is a perspective view of a seal cap of the connector of FIG. 1 ;

[0034] FIG. 8 is a perspective view of a connector according to an embodiment of the present disclosure, with a housing thereof not shown;

[0035] FIG. 9 is a perspective view of a scrubbing sensor of the connector of FIG. 8 in a preshaped state;

[0036] FIG. 10 is a perspective view of a seal cap of the connector of FIG. 8;

[0037] FIG. 11 is a cross-sectional view of the connector of FIG. 8; and

[0038] FIG. 12 is a schematic of the connector of FIGS. 1 or 8 connected to a disposable.

[0039] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.DETAILED DESCRIPTION

[0040] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the disclosure. Various modifications, equivalents, variations, and alternatives, however, will remain readily 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.

[0041] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

[0042] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value. Further, the term “substantially equal” and like terms mean that the compared values or dimensions are within a range of plus or minus ten percent of one another.

[0043] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0044] As used herein with reference to an injection apparatus such as a syringe, the term “proximal” refers to an end of the apparatus farthest from the outlet, or to a direction toward the end of the apparatus farthest from the outlet. As used herein with reference to an injection apparatus such as a syringe, the term “distal” refers to an end of the device or apparatus closest to the outlet, or to a direction toward the end of the apparatus closest to the outlet.

[0045] 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 A alone; or one or more of B alone; or one or more of C alone; 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 all of A, B, and C.

[0046] Referring first to FIGS. 1-7, an example of a needleless connector (hereinafter “connector 100”) is illustrated in accordance with the present disclosure. Generally, the connector 100 includes a body 102 having a first fitting, namely a female luer fitting 110, at one end and a second fitting, namely a male luer fitting 120, at the opposite end. A lumen extends through the body 102 of the connector 100 between the female luer fitting 110 and the male luer fitting 120 to facilitate fluid flow through the connector 100. The body 102 of the connector 100 may be generally cylindrical in shape, defining a longitudinal axis 104. A flexible seal 112 is disposed in the female luer fitting 110 and prevents contamination of the lumen by sealing the female luer fitting 110. The female luer fitting 110 is configured to receive a complementary male luer fitting of a component (e.g. a disposable such as a syringe 400, see FIG. 12) connected to the connector 100. When connected, the complementary male luer fitting depresses the seal 112 into the lumen, thereby opening at least one channel through the lumen to allow fluid flow through the connector 100.

[0047] The body 102 of the connector 100 is at least partially disposed within a housing 130, which includes a seal cap 132. The housing 130 encloses a scrubbing sensor 200 and an associated electrical module 300. FIG. 2 shows the housing 130 and seal cap 132 removedfrom the connector 100 so that underlying components of the connector 100 can be seen. The body 102 is mounted within the housing 130 a manner that allows relative movement between the body 102 and the housing 130. In some embodiments, the body 102 may be connected to the housing 130 at a pivot point. In some embodiments, the body 102 at least partially floats within the housing 130. In some embodiments, a foam or other resilient material may be located between the body 102 and housing 130 to allow relative movement.

[0048] Referring still to FIGS. 1-7, to ensure a sterile connection between the female luer fitting 110 and a connected component (e.g. a disposable such as a syringe 400, see FIG. 12), the seal 112 is disinfected prior to connection to the connected component. To disinfect the seal 112, a clinician typically grasps the housing and / or male luer fitting 120 of the connector 100 and scrubs the seal 112 with a swab pad including isopropyl alcohol or another suitable disinfectant. Because scrubbing is performed manually by the clinician, cleanliness and sterility of the seal 112 is susceptible to inconsistency if left only to the skill and experience of the clinician. To eliminate such inconsistency and ensure sufficient scrubbing is performed, the scrubbing sensor 200 validates that adequate force, pressure, intensity, and / or scrubbing duration have been applied during the scrubbing procedure.

[0049] The scrubbing sensor 200 includes at least one force sensing element, such as a force sensitive resistor (FSR), force-sensitive film, such as piezo-electric PVDF film, a membrane switch, and the like, with optionally separately activated zones, that is configured to output an electrical signal in response to an applied force or pressure. In the embodiment illustrated in FIGS. 1-7, the scrubbing sensor 200 includes a flexible substrate 210 having a sensor that includes separate zones. For example, one sensor may be divided into segments, such as five FSRs 212a, 212b, 212c, 212d, and 212e are disposed. Each of the FSRs 212a-212e is positioned to detect a force applied at a different location and / or direction relative to the connector 100. Each of the FSRs 212a-212e transmits an electrical signal to the electrical module 300 via a header 214 (e.g. a zero insertion force header, soldered header, etc.) in electrical communication with the electrical module 300. The scrubbing sensor 200 may be manufactured as a flat component, as shown in FIG. 4, and subsequently shaped (e.g. folded and / or rolled) into the profile shown in FIG. 3. In particular, the portions of the substrate 210 including the FSRs 212a, 212c are contoured around the perimeter of the body 102 such that the FSRs 212a, 212c are positioned about diametrically opposite one another on the body 102. The FSRs 212d, 212e are disposed on a front flap 211 of the substrate 210, with the front flap 211 being folded such that the FSRs 212d, 212e face substantially forward toward the femaleluer fitting 110. The header 214 of the substrate 210 is positioned to physically and electrically engage the electrical module 300.

[0050] With continued reference to FIGS. 5 and 6, the housing 130 includes one or more internal lateral ribs 140 aligned with the FSRs 212a, 212c. When the body 102 shifts laterally relative to the housing 130, causing the FSR 212a to contact the associated rib 140, the FSR 212a emits an electrical signal indicative of the applied force / pressure. Similarly, when the body 102 shifts in the opposite direction such that the FSR 212c contacts the associated rib 140, the FSR 212c emits an electrical signal indicative of the applied force / pressure. The housing 130 further includes an internal top rib 142 aligned with the FSR 212b. When the body 102 shifts vertically relative to the housing 130, causing the FSR 212b to contact the corresponding rib 142, the FSR 212b emits an electrical signal indicative of the applied force / pressure.

[0051] Electrical signals emitted by the FSRs 212a, 212b, 212c may be processed by the electrical module 300 (or may be transmitted by the electrical module 300 to an external processor) to validate that requisite force, pressure, and / or duration has been applied during a scrubbing procedure. In particular, the FSRs 212a, 212b, 212c emit signals in response to the body 102 shifting within the housing 130, which is indicative of a scrubbing motion being applied to the female luer fitting 110 while the clinical grasps the connector 100 by the housing 130 and / or the male luer fitting 120. The FSRs 212a, 212b, 212c and corresponding ribs 140, 142 may be arranged so as to engage one another in response to one or both of: (i) lateral forces acting perpendicular to the longitudinal axis 104 (corresponding to side-to-side scrubbing motions across the face of the seal 112), and (ii) torsional forces acting about the longitudinal axis 104 (corresponding to circular scrubbing motions). Based on the magnitude and / or duration of the signal emitted by one or more of the FSRs 212a, 212b, 212c, the electrical module 300 (or external processor) can determine whether sufficient scrubbing has been performed to ensure that the seal 112 is disinfected.

[0052] Referring now to FIG. 7, the seal cap 132 may include a lip 134 that connects to a corresponding lip 138 of the housing 130 (see FIGS. 5 and 6). The seal cap 132 further includes one or more contact pads 136 aligned with the FSRs 212d, 212e (see FIGS. 3 and 4). Thus, force and / or pressure applied to the contact pads 136 is transmitted to the corresponding FSRs 212d, 212e, thereby causing the FSRs 212d, 212e to emit an electrical signal indicative of the applied force / pressure. Electrical signals emitted by the FSRs 212e, 212f may be processed by electrical module 300 (or may be transmitted by the electrical module 300 to an external processor) to detect connection of certain disposables 400 (see FIG. 12) to the female luerfitting 110. That is, certain disposables 400 may have structure configured to engage the contact pads 136 of the seal cap 132 when the disposables 400 are connected to the female luer fitting 110, thereby applying a force / pressure to the FSRs 212e, 212f.

[0053] Based on the electrical signal emitted by the FSRs 212e, 212f, the electrical module 300 can detect the presence of a disposable 400 connected to the female luer fitting 110. Further, based on the electrical signal emitted by the FSRs 212e, 212f, the electrical module 300 can validate that the disposable 400 is fully seated, by determining that the force that the disposable 400 applies to the contact pads 136 meets or exceeds a known and / or predetermined connecting force. The known and / or predetermined connecting force may be difference for different types of disposables 400. Thus, based on the electrical signal emitted by the FSRs 212e, 212f, the electrical module 300 can detect the type of disposable 400 connected to the female luer fitting 110.

[0054] Referring now to FIGS. 8-11, another embodiment of the connector 100 is substantially similar to the embodiment of FIGS. 1-7, with like reference numerals indicating identical or functionally equivalent components. Differences between the embodiments include that the seal cap 133 of FIGS. 8-11, which is functionally similar to the seal cap 132 of FIGS. 1-7, fits substantially within the housing 130, and that the seal cap 133 includes a continuous contact pad 137 entirely surrounding an orifice 139 through which the female luer fitting 110 extends. The contact pad 137 is aligned with certain FSRs of the scrubbing sensor 200 in the same manner as the contact pads 136 of FIGS. 1-7. In particular, the flap 211 of the flexible substrate 210 of the scrubbing sensor 200 entirely surrounds the female luer fitting 110, and includes three FSRs 212f, 212g, 212h. Force and / or pressure applied to the contact pad 137 is transmitted to the FSRs 212f, 212g, 212h, thereby causing the FSRs 212f, 212g, 212h to emit an electrical signal indicative of the applied force / pressure. The FSRs 212f, 212g, 212h may be used to detect connection of a disposable (e.g. a syringe 400, see FIG. 12) to the female luer fitting 110 based on the force / pressure that the disposable 400 applies to the contact pad 137. Additionally, the electrical module 300 may be configured to validate the connection of the disposable 400, and to determine the type of disposable 400 connected, based on the electrical signal emitted by the FSRs 212f, 212g, 212h in substantially the same manner discussed in connection with FIGS. 1-7.

[0055] While the embodiments of the scrubbing sensor 200 illustrated in FIGS. 1-11 utilize FSRs 212a-212h to detect force and / or pressure, the FSRs could be substituted for alternative force sensing elements such as piezoelectric elements, membrane switches, and / or the like. The sensitivity of the scrubbing sensor 200 may be configured mechanically and / or electricallyto provide a binary signal, such as one of a digital signal and an analog signal, or at least one of a transient signal or a static signal output as needed to balance the competing goals of sensor resolution and computational overhead. Additionally, each of the FSRs 212a-212h (or alternate force sensing elements) may be configured individually to a desired sensitivity.

[0056] Although the invention has been described in detail for the purpose of illustration based on what is currently 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 that are within the spirit and scope of the appended claims. For example, it is to be understood that the present 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

THE INVENTION CLAIMED IS:

1. A connector for an intravenous administration system, the connector comprising: a housing; a body at least partially disposed in the housing and defining a longitudinal axis and a lumen; a first fitting at a first end of the body; a second fitting 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, wherein the body is movable relative to the housing, wherein the scrubbing sensor comprises 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 of claim 1, wherein the one or more force sensing elements comprise at least one of a force sensitive resistor, a piezoelectric film, and a membrane switch.

3. The connector of claim 1, wherein the scrubbing sensor comprises a flexible substrate on with the one or more force sensing elements are disposed.

4. The connector of claim 1, wherein the housing comprises one or more ribs aligned with the one or more force sensing elements.

5. The connector of claim 3, wherein the flexible substrate is contoured around the body such that two of the at least one force sensing elements are positioned about one another on the body.

6. The connector of claim 1, wherein the flexible substrate engages an electrical module for receiving the electrical signals emitted by the one or more force sensing elements.

7. The connector of claim 1, wherein the housing comprises a seal cap having one or more contact pads aligned with at least one of the one or more force sensing elements.

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

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

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

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

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

14. The connector of 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 of 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 of claim 1, wherein the one or more force sensing elements comprises at least two force sensing elements having different sensitivities.

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

18. The connector of claim 1 , wherein the body at least partially floats in the housing.

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

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

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