Instrument conveying device
By integrating the scrubbing cap in the instrument conveying device, the problem of difficulty in completely disinfecting the needleless connector is solved, and comprehensive cleaning and disinfection of the needleless connector is achieved, ensuring sterile conditions and reducing the risk of infection.
Patent Information
- Application Number
- CN202420885446.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Priority Date
- 2023-04-25
- Filing Date
- 2024-04-25
- Publication Date
- 2025-02-11
- Estimated Expiration
- 2034-04-25
AI Technical Summary
Prior art When using pinless connectors, it is difficult to completely and effectively disinfect all its inner and outer surfaces, especially in complex threaded areas, and do not comply with sterile non-contact technical standards.
An instrument conveying device is designed, which is integrated with a scrubbing cap, connected to the catheter assembly through a coupling device, and using the cleaning substance and structure of the scrubbing cap, it is possible to effectively clean the inner and outer surfaces of the needleless connector, including complex threaded areas.
Complete disinfection of needleless connectors is achieved, ensuring sterile conditions before the connection device delivery device, reducing the risk of catheter-related blood flow infection, and complying with sterile non-contact technical standards.
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Figure CN222445154U_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to U.S. Provisional Application No. 63 / 461,695, filed on April 25, 2023, entitled “Instrument Delivery Device with Integrated Scrubbing Cap and Method of Use Thereof,” the entire disclosure of which is incorporated herein by reference. Technical Field
[0003] The present disclosure relates to a catheter system with an integrated scrub cap. Background Art
[0004] Catheters are commonly used to inject fluids into the body and remove fluids from the body. Patients in various settings, including in hospitals and home care, receive fluids, medications, and blood products via a vascular access device (VAD), which includes such a catheter inserted into the patient's vascular system. Common VADs include plastic catheters inserted into the patient's veins, where, as an example, the length of the catheter varies from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to many centimeters when the VAD is a central venous catheter (CVC). VADs can be indwelled for a short period of time (several days), a medium period of time (several weeks), or a long period of time (several months to years).
[0005] In many VADs, a needleless connector is used to close the VAD (i.e., seal the hub or port of the VAD) when an intravenous (IV) catheter is used, wherein the needleless connector is subsequently accessed to introduce an instrument into the patient (via the catheter) to draw blood, infuse medication or other necessary fluids, and / or provide blood-related monitoring or analysis. That is, a blood drawing device or other instrument delivery device can be coupled to the needleless connector to provide for the introduction and advancement of a catheter or other instrument (e.g., a guidewire, probe, etc.) into the IV catheter. In such an arrangement, the needleless connector must be properly cleaned and disinfected before the device is engaged with the needleless connector to prevent the entry of microorganisms and possible catheter-related blood stream infection (CRBSI). Currently, clinicians often use alcohol wipes to wipe and disinfect the needleless connector before connecting a blood drawing device or instrument delivery device. However, using alcohol wipes to clean and disinfect needleless connectors in this manner is often not completely effective in disinfecting all interior / exterior surfaces of the needleless connector, including the complex threaded area around the luer portion of the needleless connector that couples with the blood draw or instrument delivery device. In addition, using alcohol wipes to clean and disinfect needleless connectors does not meet Aseptic Non-Touch Technique (ANTT) standards.
[0006] Therefore, there is a need in the art for a scrubbing device that can disinfect a needleless connector (or other access port) of a peripheral IV catheter prior to connecting a blood drawing device or other instrument delivery device to the needleless connector and that complies with the ANTT standard. Utility Model Content
[0007] The present invention provides an instrument delivery device that can be coupled to a catheter assembly that includes a catheter that can be positioned intravenously in a patient's body. The instrument delivery device includes: an instrument that is configured to be inserted into a catheter; a housing that has a proximal end and a distal end and defines an internal volume that is configured to movably receive the instrument; a coupling device that is positioned at the distal end of the housing and includes a lock that is configured to couple the housing to a proximal connector of the catheter assembly; and a propulsion member that is configured to move relative to the housing to move the instrument between a first position and a second position, in which the distal end of the instrument is disposed within the housing or within the lock, and in which the distal end of the instrument is disposed within the catheter or beyond the distal end of the catheter. The instrument delivery device also includes a scrub cap that engages with the lock, wherein the scrub cap also includes: a scrub insert; a housing, the housing of the scrub cap including a connector portion and a retainer portion, the connector portion being configured to engage with the lock to secure the scrub cap to the instrument delivery device, the retainer portion being distal to the connector portion and including a cavity configured to retain the scrub insert in the cavity; and a seal attached to the retainer portion to seal the scrub insert within the cavity. The scrub cap engages with the lock in a manner that allows the scrub cap to be removed from the instrument delivery device.
[0008] In some embodiments, the connector portion includes a protrusion having a distal end and a proximal end, the distal end of the protrusion being coupled to the connector portion, the proximal end of the protrusion having an opening formed therein, the opening providing access to a channel formed in the protrusion.
[0009] In some embodiments, the lock comprises an elongated member insertable into the channel of the protrusion and a pair of locking arms positioned on opposite sides of the elongated member and engageable with the protrusion.
[0010] In some embodiments, the protrusion of the connector portion includes: a first portion having a first outer diameter; a second portion positioned proximal to the first portion and having a second outer diameter smaller than the first outer diameter, the second portion including an opening; and an annular flange disposed between the first portion and the second portion and forming a lip, wherein the annular flange is positioned so that: when the elongated member is inserted into the channel, the hooked end of each locking arm of the pair of locking arms engages with the lip of the annular flange.
[0011] In some embodiments, the first part includes a pair of retaining stops formed on the outer surface of the first part and adjacent to the annular flange, the pair of retaining stops being arranged to form a retaining seat that receives the hooked ends of the corresponding locking arms of the pair of locking arms, wherein the retaining seat prevents circumferential displacement of the locking arms.
[0012] In some embodiments, the channel includes: a first channel portion, which is formed in the first portion of the protrusion; and a second channel portion, which is formed in the second portion of the protrusion, wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter.
[0013] In some embodiments, the elongated member includes a male luer portion and a blunted cannula portion extending distally from the male luer portion, wherein the blunted cannula portion is sized to fit within the first channel portion and the male luer portion is sized to fit within the second channel portion.
[0014] In some embodiments, the elongate member includes or is a male luer connector sized to fit within the second channel portion, and the first channel portion remains open when the elongate member is inserted into the channel.
[0015] In some embodiments, the lock includes an elongated member insertable into the channel of the protrusion and a ferrule positioned about the elongated member and including a threaded inner surface.
[0016] In some embodiments, the protrusion of the connector portion includes a threaded outer surface configured to engage the threaded inner surface of the ferrule to secure the scrub cap to the lock.
[0017] In some embodiments, the elongate member includes or is a male luer connector sized to fit within the passageway.
[0018] In some embodiments, the protrusion of the connector portion includes a first portion and a second portion positioned proximally of the first portion, wherein the second portion includes the opening and the threaded outer surface is formed on the second portion.
[0019] In some embodiments, the channel includes a first channel portion formed in the first portion of the protrusion and a second channel portion formed in the second portion of the protrusion, wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter.
[0020] In some embodiments, the elongated member includes a male luer portion and a blunted cannula portion extending distally from the male luer portion, wherein the blunted cannula portion is sized to fit within the first channel portion and the male luer portion is sized to fit within the second channel portion.
[0021] In some embodiments, the cavity in the holder portion and the scrub insert are sized and reconfigured to receive a female Luer connection of the proximal connector of the catheter assembly.
[0022] A method of using an instrument delivery device having a scrub cap integrated with the instrument delivery device is also provided. The method includes: removing a seal from a retainer portion; positioning a proximal connector of a catheter assembly into the retainer portion so that the proximal connector contacts a scrub insert; and cleaning the proximal connector with the scrub insert by applying a twisting motion to the instrument delivery device.
[0023] In some embodiments, the method further comprises removing the scrub cap from the lock after cleaning the proximal connector, and coupling the lock to the proximal connector, wherein when the lock is coupled to the proximal connector, the instrument delivery device is operable to move the instrument from the first position to the second position.
[0024] The present invention also provides a method for manufacturing an instrument delivery device that can be coupled to a catheter assembly, the catheter assembly including a catheter that can be positioned intravenously in a patient's body. The method includes providing an instrument delivery device, the instrument delivery device including: an instrument, the instrument is configured to be inserted into the catheter; a housing having a proximal end and a distal end and defining an internal volume configured to movably receive the instrument; a coupling device, the coupling device is positioned at the distal end of the housing, and the coupling device includes a lock, the lock is configured to couple the housing to the proximal connector of the catheter assembly; and a propulsion member, the propulsion member is configured to move relative to the housing to move the instrument between a first position and a second position, in which the distal end of the instrument is disposed in the housing or in the lock, and in which the distal end of the instrument is disposed in the catheter or beyond the distal end of the catheter. The method also includes engaging a scrub cap with the lock, the scrub cap including: a scrub insert; a housing, the housing of the scrub cap including a connector portion and a retainer portion, the connector portion being configured to engage with the lock to secure the scrub cap to the instrument delivery device, the retainer portion being distal to the connector portion and including a cavity configured to retain the scrub insert in the cavity; and a seal attached to the retainer portion to seal the scrub insert within the cavity. The scrub cap engages with the lock in a manner that allows the scrub cap to be removed from the instrument delivery device.
[0025] In some embodiments, engaging the scrub cap with the lock includes inserting an elongated member of the lock into a channel formed in the connector portion of the scrub cap and clamping a pair of locking arms of the lock onto an annular flange formed around a protrusion of the connector portion.
[0026] In some embodiments, a locking arm of the pair of locking arms is secured between a pair of retaining stops formed on the protrusion of the connector portion, thereby preventing circumferential displacement of the pair of locking arms relative to the connector portion.
[0027] In some embodiments, engaging the scrub cap with the lock includes inserting the elongated member of the lock into a channel formed in the connector portion of the scrub cap and threadingly engaging an internally threaded ferrule of the lock with a threaded outer surface of a protrusion of the connector portion. BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Figure 1 is a perspective view of a catheter system according to one aspect or embodiment of the present application;
[0029] Figure 2 According to one aspect or embodiment of the present application Figure 1 A perspective view of an instrument delivery device of the system;
[0030] Figure 3 yes Figure 2 An exploded view of the device delivery device;
[0031] Figure 4 yes Figure 2 A side cross-sectional view of an instrument delivery device showing the instrument in a first retracted position;
[0032] Figure 5 yes Figure 2 A side cross-sectional view of an instrument delivery device showing the instrument in a second retracted position;
[0033] Fig. 6A According to one aspect or embodiment of the present application Figure 2 An exploded view of a scrub cap included in an instrument delivery device and a coupling device of the instrument delivery device;
[0034] Figure 6B Is matched with the coupling device Fig. 6A Detailed view of the scrub cap;
[0035] Figure 7 yes Fig. 6A A cross-sectional view of a scrubbing cap and a coupling device;
[0036] Figure 8 yes Fig. 6AA cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0037] Fig. 9 According to one aspect or embodiment of the present application, Figure 1 An exploded view of a scrub cap and associated coupling device for use with a system;
[0038] Fig.10 yes Fig. 9 A cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0039] Fig.11 According to one aspect or embodiment of the present application, Figure 1 An exploded view of a scrub cap and associated coupling device for use with a system;
[0040] Fig.12 yes Fig.11 A cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0041] Fig.13 According to one aspect or embodiment of the present application, Figure 1 An exploded view of a scrub cap and associated coupling device for use with a system;
[0042] Fig.14 yes Fig.13 A cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0043] Fig.15 According to one aspect or embodiment of the present application, Figure 1 An exploded view of a scrub cap and associated coupling device for use with a system;
[0044] Fig.16 yes Fig.15 A cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0045] Fig.17 According to one aspect or embodiment of the present application, Figure 1 An exploded view of a scrub cap and associated coupling device for use with a system;
[0046] Fig.18 yes Fig.17 A cross-sectional view of a scrub cap and a coupling device, wherein the scrub cap is positioned above the proximal connector;
[0047] Fig.19 According to one aspect or embodiment of the present application, Figure 1An exploded view of a scrub cap and associated coupling device for use with a system;
[0048] Fig. 20 yes Fig.19 A cross-sectional view of a scrub cap and coupling device, wherein the scrub cap is positioned above the proximal connector. DETAILED DESCRIPTION
[0049] The following description is provided to enable those skilled in the art to make and use the various aspects described for implementing the present invention. However, various modifications, equivalents, variations and substitutes will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present disclosure.
[0050] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless otherwise expressly stated. 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. Therefore, the specific dimensions and other physical characteristics associated with the various aspects disclosed herein should not be considered limiting.
[0051] In the present disclosure, the distal end of a component or device refers to the end farthest from the user's hand when the component or device is in the use position, i.e., when the user holds the catheter insertion device ready for use or during use, and the proximal end refers to the end closest to the user's hand. Similarly, in the present application, the terms "in the distal direction" and "distally" refer to the direction toward the distal end of the needle or catheter of the system, while the terms "in the proximal direction" and "proximally" refer to the direction opposite to the direction of the distal end of the needle or catheter.
[0052] refer to Figure 1 , Figure 1 A non-limiting embodiment of a catheter system 10 according to one aspect or embodiment of an embodiment of the present invention may be implemented is shown. The catheter system 10 includes a catheter assembly 12, and an associated instrument delivery device 14 may be used with the catheter assembly 12. Although the instrument delivery device 14 is described below as a delivery device for introducing a tube of a catheter into the catheter assembly 12 to draw blood (i.e., a "blood drawing device"), it should be appreciated that, as other non-limiting examples, the instrument delivery device may alternatively deliver another suitable instrument (e.g., a guidewire or a sensing probe) into the patient's vasculature.
[0053] According to one embodiment, the catheter assembly 12 includes a catheter hub 16 and a non-integrated extension kit 18, which includes a catheter stabilizing catheter connector 20 (hereinafter referred to as "catheter connector 20") and an extension tube 22. The catheter hub 16 receives a catheter 24 and is coupled to the catheter connector 20. In one aspect or embodiment, the catheter hub 16 can be an AccuCath commercially available from Becton, Dickinson and Company. TM Catheter system.
[0054] The catheter connector 20 is configured to contact the patient's skin surface at or near the insertion site of the catheter 24. The catheter connector 20 can have any suitable shape, size and / or configuration. In the non-limiting embodiment shown, the catheter connector 20 has a connector portion 26 and a stabilizing portion 28. The connector portion 26 has a proximal port with a proximal connector 30, a distal port with a distal connector 32, and defines at least one lumen (not shown) extending through the connectors 30 and 32 or otherwise communicating with the connectors 30 and 32 fluids. The proximal connector 30 and / or the distal connector 32 can be, for example, a male Luer lock or a female Luer lock and / or any other suitable connector. In the embodiment shown, the proximal connector 30 is set to a needleless access connector (i.e., a needleless connector (Needle-free Connector, NFC)), hereinafter referred to as a "needleless access connector 30", which can be physically and fluidically coupled to a peripheral device, such as a blood drawing device (e.g., a PIVO from Beckton Dickinson) TM ), or a Vascular Access Probe (VAP) for intravenous digital measurement of patient data (e.g., temperature, pH, lactate, and / or other blood-based measurements). The proximal connector 30 presents a female Luer connector / lock to which such a peripheral device can be connected. The distal connector 32 can be physically and fluidically coupled to the catheter hub 16 so that the lumen of the connector portion 26 is at least selectively in fluid communication with the catheter 24. In some embodiments, the inner surface of the connector portion 26 can be configured to provide alignment, guidance, centering, etc. to an object or device (e.g., a blood drawing catheter, etc., as described above) that is advanced through the connector portion.
[0055] Connector portion 26 may also include and / or define one or more additional ports, such as side port 34. Side port 34 may be included in connector portion 26, proximal connector 30, distal connector 32, and / or a combination thereof, and / or side port 34 may be part of: connector portion 26, proximal connector 30, distal connector 32, and / or a combination thereof. In some cases, positioning side port 34 at a desired location along the length of connector portion 26 between connector 30 and connector 32 may allow for a reduction in the length of connector portion 26 and / or may facilitate flushing and / or fluid transfer via side port 34.
[0056] The side port 34 defines a lumen (not shown) that is in fluid communication with a lumen located between the distal connector 32 and the proximal connector 30. In other words, the connector portion 26 and / or the side port 34 may include and / or define a first lumen (e.g., located between the distal connector 32 and the proximal connector 30) and a second lumen (e.g., a lumen defined by the side port 34 and the extension tube 22). Thus, the side port 34 may provide access to the lumen between the distal connector 32 and the proximal connector 30, which in turn may provide access to a device (e.g., a VAD) coupled to the distal connector 32 and / or may provide access to a portion of the body in which the VAD is at least partially disposed.
[0057] In some embodiments, the arrangement of the side ports 34 can be such that the connector portion 26 forms, for example, a Y-shaped connector or a T-shaped connector. More particularly, the side ports 34 can be substantially disposed perpendicular (e.g., approximately 90 degrees) to the lumen of the connector portion 26 and close to or adjacent to the proximal connector 30. In a non-limiting embodiment, the side ports 34 extend from the connector portion 26 at an angle other than 90 degrees relative to the lumen between the distal connector 32 and the proximal connector 30 (e.g., the side ports 34 extend at an angle within a range of, for example, but not limited to, 15 degrees to 165 degrees (including all values and sub-ranges therebetween)). In a non-limiting embodiment, more than one side port 34 is included in the connector portion 26.
[0058] like Figure 1As shown, the side port 34 can be coupled to the extension tube 22 so that the extension tube 22 is in fluid communication with the lumen of the side port 34. In some embodiments, the side port 34 and / or the extension tube 22 can be and / or can form at least a portion of a fluid line that can be used to deliver fluids, remove fluids, and / or flush fluids, etc. In such embodiments, for example, the arrangement of the side port 34 adjacent to the proximal connector 30 can enable flushing of the proximal connector 30, any one or more valves included in the proximal connector, and / or the space between any one or more valves and the inner surface of the connector portion 26 (e.g., defining at least a portion of the lumen).
[0059] As shown, the extension set 18 includes a proximal access port 36 coupled to a proximal portion of the extension tube 22, wherein the extension tube 22 is in fluid communication with the side port 34 of the catheter connector 20. A clamp 38 may be disposed on the extension tube 22, wherein the clamp 38 is configured to selectively restrict flow through the extension tube 22.
[0060] Reference again Figure 1 , and now also refer to Figure 2 and Figure 3 , the instrument delivery device 14 (hereinafter referred to as the "blood drawing device 14") includes a housing 70, a coupling device 72, a catheter 74, an auxiliary catheter 76, and a propulsion member 78. As further described in detail herein, a user can convert the blood drawing device 14 from a first configuration to a second configuration to advance the catheter through an existing, placed and / or indwelling catheter 24 (i.e., when the blood drawing device 14 is coupled to the catheter 24) so that at least an end of the catheter 74 is disposed in a distal position relative to the indwelling catheter 24. In addition, where each indwelling catheter each has a shape, size, and / or configuration that can vary based on, for example, the manufacturer of the indwelling catheter 24 and / or its intended use, the blood drawing device 14 can be arranged to couple to an indwelling catheter 24 having any suitable configuration and subsequently advance at least a portion of the catheter through the indwelling catheter 24. Furthermore, the blood drawing device 14 can be manipulated by a user to position the distal surface of the catheter 74 a predetermined and / or desired distance beyond the distal surface of the indwelling catheter 24 to be disposed within a portion of a vein that receives substantially unobstructed blood flow.
[0061] The housing 70 of the blood drawing device 14 can be an elongated member having a proximal end 80 and a distal end 82 and defining an internal volume 83. In some embodiments, the housing 70 can be formed by a pair of housing portions 70a, 70b coupled together to define the internal volume 83. The housing 70 can include one or more features or surface finishes on its outer surface, which can be arranged to increase the ergonomics of the blood drawing device 14, which in some cases can allow the user to manipulate the blood drawing device 14 with one hand (i.e., one-handed use). The distal end 82 of the housing 70 can include a coupler 84 formed thereon, the coupler 84 being configured to cooperate with the coupling device 72 of the blood drawing device, and in one embodiment, the coupler 84 can include a threaded inner surface that engages with the coupling device 72. In addition, the proximal end 80 of the shell 70 may include an opening or port 85, which is configured to receive a portion of the auxiliary catheter 76 (i.e., the portion of the auxiliary catheter 76 extending proximally from the shell 70) and provide advancement and retraction of the auxiliary catheter 76 through the port 85.
[0062] The coupling device 72 of the blood drawing device 14 is disposed at the distal end 82 of the housing 70, wherein the coupling device 72 provides a connection between the blood drawing device 14 and the catheter assembly 12 (e.g., via Figure 1 In some embodiments, the coupling device 72 is configured as a lock 86, and the lock 86 includes a blunting cannula 88 and a locking arm 90 for coupling to the needleless access connector 30 of the catheter assembly 12, wherein the blunting cannula 88 and the locking arm 90 form three contact points. However, those skilled in the art will recognize that as long as the distal end of the catheter 74 can pass through the coupling device 72 to approach the catheter assembly 12, any connector or coupling member, such as a Luer member, can be used. In addition, the proximal end of the coupling device 72 can be configured as a threaded connector 91 (that is, a threaded outer surface), which is configured to engage with the coupler 84 of the housing 70, wherein the threaded connector 91 of the coupling device 72 engages with the threaded inner surface of the coupler 84.
[0063] According to some aspects of the present disclosure, the pusher member 78 of the blood drawing device 14 includes a first portion 92 and a second portion 94. The first portion 92 is movably disposed along an upper surface 96 of the housing 70, and the second portion 94 is movably disposed within the interior volume 83 of the housing 70. The pusher member 78 and the housing 70 are arranged so that a connector portion (not shown) of the pusher member 78 that joins the first portion 92 and the second portion 94 is located within a groove 98 formed in the upper surface 96 of the housing 70, the groove 98 generally extending between the proximal end 80 and the distal end 82 of the housing 70. When the first portion 92 and the second portion 94 are coupled together, movement of the first portion 92 along the upper surface 96 of the housing 70 causes corresponding movement of the second portion 94 within the interior volume 83.
[0064] like Figure 2 and Figure 3 As shown, the first portion 92 of the advancement member 78 can be configured as a tab 100 having a contact surface that can be engaged by a user and a bottom surface that contacts the outer surface 96 of the housing 70. In such an embodiment, the upper surface 96 of the housing 70 can include a track 101, such as a set of ribs, ridges, protrusions and / or grooves, etc., along which the bottom surface of the tab or protrusion advances when the user engages the advancement member 78. In this way, the user can engage the first portion 92 of the advancement member 78 and can move the advancement member 78 relative to the housing 70.
[0065] like Figure 3 As further shown, the second portion 94 includes an opening 102 extending therethrough, the opening 102 being configured to grip or retain a portion of the catheter 74. Because the portion of the catheter 74 is retained within the opening 102 of the second portion 94, movement of the advancement member 78 relative to the housing 70 causes corresponding movement of the catheter 74 relative to the housing 70. In this manner, the distal end 104 of the catheter 74 can be selectively moved out of or back into the interior volume 83 of the housing 70 as desired, such as by advancing the distal end 104 of the catheter 74 out of the housing 70 when the blood drawing device 14 has been coupled to the catheter assembly 12 and a blood drawing procedure is to be performed.
[0066] In addition to receiving the catheter 74 therein, the second portion 94 also clamps or retains a portion of the auxiliary catheter 76 therein. That is, the distal end 106 of the auxiliary catheter 76 is fixed to the second portion 94 (i.e., in the opening 102 thereof) and extends proximally therefrom, wherein the auxiliary catheter 76 extends out through the opening 85 of the housing 70. The proximal end 108 of the auxiliary catheter 76 can include a coupler 110 thereon, which can be coupled to a fluid reservoir, a fluid source, a syringe, a vacuum container or a pump, etc., wherein the auxiliary catheter 76 establishes fluid communication between the reservoir, fluid source, pump, etc. and the catheter 74. In addition, in some embodiments, the auxiliary catheter 76 can also have a clamp 112 disposed thereon, such as a sliding clamp or a spring clamp, to facilitate blocking flow through the auxiliary catheter 76.
[0067] Reference now Figure 4 and Figure 5 , Figure 4 and Figure 5 1 and 2 show the change of the blood drawing device 14 between the first configuration and the second configuration. The blood drawing device 14 can be in the first configuration before use, and can be changed from the first configuration ( Figure 4 ) to the second configuration ( Figure 5 ) to position at least the distal end 104 of the catheter 74 in a distal position relative to the housing 70.
[0068] When the conduit 74 is disposed in the first position within the housing 70, the blood drawing device 14 is in Figure 4 In some embodiments, when the conduit 74 is in the first position, substantially the entire conduit 74 is disposed within the housing 70. In other embodiments, when the conduit 74 is in the first position, the conduit 74 is disposed within the housing 70 and the lock 86.
[0069] When the blood drawing device 14 is in the first configuration, the advancement member 78 is disposed in the proximal position and the user can engage the tab 100 of the advancement member 78 to move the advancement member 78 relative to the housing 70, which in turn moves the catheter 74 from the first position (e.g., disposed within the housing 70) to the second position. In this manner, the catheter 74 is moved through the interior volume 83 of the housing 70 and through the lock 86 such that at least the distal end 104 of the catheter 74 is disposed outside and distal to the lock 86.
[0070] When the catheter 74 is set in the second position, the blood drawing device 14 is in Figure 5The second position of catheter 74 is reached when distal end 104 of catheter 74 is placed in a desired position relative to the distal end of catheter 24. In some cases, for example, when catheter 74 is in the second position, distal end 104 of catheter 74 may be substantially flush with the distal end of catheter 24. In other cases, distal end 104 of catheter 74 may extend beyond the distal end of catheter 24 by a predetermined distance, such that distal end 104 of catheter 74 is positioned within the vein at a predetermined distance beyond the distal end of catheter 74 (e.g., a position within the vein that is substantially free of debris (e.g., fibrin / blood clots) that would otherwise surround the distal portion of catheter 24).
[0071] When the catheter 74 is in the second position (e.g., when the blood drawing device 14 is in the Figure 5 In the second configuration shown, the user can establish fluid communication between the fluid reservoir, fluid source, and / or syringe, etc. and the catheter 74. The blood drawing device 14 can then be based at least in part on positioning the distal end 104 of the catheter 74 beyond the catheter 24 ( Figure 1 ) to draw a certain amount of blood from the vein at a predetermined distance and / or a desired distance from the distal surface of the catheter 74. In some cases, once the desired amount of blood has been collected and / or once the desired volume of drug has been delivered to the patient, the user can move the advancement member 78 in the proximal direction, such as moving the advancement member 78 back to its most proximal position, so as to move the catheter 74 back to the first position.
[0072] Although the instrument delivery device 14 is Figures 1 to 5 70 is shown and described as having a propulsion member 68 having a first portion 92 and a second portion 94 configured to move along an upper surface 96 of a housing 70 and within an interior volume 83 of the housing 70, but it should be appreciated that the instrument delivery device 14 can have an alternatively configured propulsion member. For example, according to another embodiment, the instrument delivery device 14 can be configured to have a nested housing arrangement, wherein the propulsion member is configured as a telescoping cylinder that can move within the housing 70 to advance (and retract) the catheter 74. It should be appreciated that according to aspects of the present disclosure, the instrument delivery device 14 can still implement other propulsion member configurations.
[0073] It should be appreciated that when the blood drawing device 14 is initially connected to the catheter assembly 12 (via the coupling of the lock 86 to the needleless access connector 30), it is desirable to sterilize the needleless access connector 30 prior to connecting the blood drawing device 14 to the needleless access connector 30. That is, it is desirable to clean and sterilize the needleless access connector 30 prior to engaging the lock 86 (e.g., by inserting the blunted cannula 88 into the needleless access connector 30) with the needleless access connector 30 to prevent microbial entry and possible catheter-related bloodstream infection (CRBSI).
[0074] According to aspects of the present disclosure, a scrub cap 116 is integrated with the blood drawing device 14 to clean and disinfect the needleless access connector 30 prior to engaging the blood drawing device 14 with the needleless access connector 30. The scrub cap 116 is secured to the lock 86 and is configured to engage with the needleless access connector 30 to enable cleaning and disinfection of the interior and / or exterior surfaces of the needleless access connector 30, such as by a twisting and scrubbing motion between the scrub cap 116 and the needleless access connector 30. After the cleaning and disinfection of the needleless access connector 30 is completed, the scrub cap 116 can be removed from the lock 86, thereby enabling the lock 86 to be subsequently coupled to the needleless access connector 30 and the catheter 74 of the blood drawing device 14 to be advanced into the catheter assembly 12.
[0075] like Figures 1 to 3 As shown and now FIG. 6A to FIG. 8 As shown, the scrub cap 116 includes a cap body 118, a scrub insert 120, and a peelable seal 122. The cap body 118 can be an integrally molded structure made by injection molding and can be made of an alcohol-compatible material such as polypropylene or polyethylene. The cap body 118 can generally be described as including a retainer portion 124 and a connector portion 126, wherein the retainer portion 124 retains the insert 120 therein, and the connector portion 126 is configured to cooperate with the coupling device 72 (i.e., the lock 86) of the blood drawing device 14.
[0076] The holder portion 124 may have a cup shape formed by a base 128 and a sidewall structure 130, the sidewall structure 130 defining an opening 132 at one end thereof. The sidewall structure 130 is integrally formed with the base 128 to define a cavity 134 configured to receive the insert 120 therein. FIG. 6A to FIG. 8 As shown, the cavity 134 can have a cylindrical cross-sectional shape, and the cavity 134 can have a depth suitable for receiving the insert 120 in a recessed manner therein. However, it should be understood that the retainer portion 124 and the cavity 134 defined thereby can take other shapes, including square, hexagonal, etc., and the shape and size of the retainer portion 124, the cavity 134 of the retainer portion, and the insert 120 disposed in the cavity can be configured to enable the scrub cap 116 to clean a medical device of a specific size and configuration to be used with the scrub cap 116 (i.e., the catheter connector 20 of the catheter assembly 12).
[0077] The retainer portion 124 may be sized so that the cavity 134 defined by the sidewall structure 130 compresses the insert 120 when the insert 120 is installed in the cavity 134, thereby retaining the insert 120 in the cavity. The insert 120 may also be adhered to the bottom (i.e., base 128) of the retainer portion 124 using a suitable hot melt glue or other suitable adhesive, although it should be appreciated that other suitable methods (including, for example, mechanical fastening) may also be used to secure the insert 120 to the retainer portion 124. An annular lip 136 may be formed on the retainer portion 124 (i.e., on the sidewall structure 130) around the opening 132 to define a platform for receiving the seal 122, wherein the seal 122 cooperates with the annular lip 136 to seal the opening 132 of the cavity 134 and retain the insert 120 in the cavity. The seal 122 seals the cavity 134 of the holder portion 124 and the insert 120 therein to prevent contamination from the external environment and provides a leak-proof barrier to protect the contents of the insert 120 and maintain a sealed, sterile environment. The seal 122 provides adequate sealing over a range of temperatures, pressures, and humidity levels and, according to various embodiments, may be formed as an aluminum or multi-layer polymer film peel-top member. In some embodiments, the seal 122 is heat-sealed or induction-sealed to the open end of the scrub cap 116. The seal 122 may include tabs 138 to facilitate manipulation of the seal 122 and removal of the seal 122 from the scrub cap 116.
[0078] The insert 120 is made of a foam material such as an injection molded structure, or the insert 120 can be die-cut from a foam sheet. According to various embodiments, the foam insert 120 can be open-cell, semi-open-cell or closed-cell. The insert 120 includes a cleaning substance impregnated therein (while in the retainer portion 124), such as a solution of a suitable microbicide or bactericide. Depending on the size of the insert of the foam material, the cleaning substance can include any suitable type and amount of antibacterial disinfectant. For example, in one embodiment, a volume of from about 0.20cc (cubic centimeters) to about 0.75cc of an aqueous solution is used, the aqueous solution including about two percent (2%) chlorhexidine gluconate (Chlorhexidine Solution, "CHG"). Alternatively, a solution including about 0.50cc is used. In another embodiment, the cleaning substance includes a solution including about 70 percent (70%) isopropyl alcohol (Isopropyl Alcohol, "IPA") in an aqueous solution. In yet another embodiment, the cleaning substance includes a solution comprising about 70 percent (70%) IPA and about 2 percent (2%) CHG in an aqueous solution in an amount of about 0.2 ml. In the latter solution, it should be appreciated that in one embodiment, the concentration of IPA can vary from about 60 percent (60%) to about 90 percent (90%), and the concentration of CHG can vary from about one percent (1%) to about five percent (5%). Other suitable solution compositions and concentrations are also possible. For example, in one embodiment, a povidone-iodine solution or a hydrogen peroxide solution can be included in the cleaning substance.
[0079] According to various aspects of the present disclosure, the insert 120 can be constructed (e.g., molded) to have a predetermined shape that conforms to the characteristic shape of the patient-end connector (i.e., the proximal connector 30) to be cleaned by it. The insert 120 can also have any of a variety of structures that provide effective cleaning of the connector, such as including a patterned or rough top surface and / or gaps or slits formed in its foam material so that the insert 120 can better deform / conform to the inner and outer surfaces of the connector. In one embodiment, the insert 120 is constructed to have a cylindrical shape, wherein the insert 120 is fingered, that is, cross-cut with a slit 140 in each of two perpendicular directions to form separate fingers 142. The slit 140 extends downwardly a portion of the height of the insert 120, for example, so that the fingers 142 extend upwardly from a common base 144 of a cylindrical cross-sectional shape in one piece. It should also be recognized that the insert 120 can have a cubic shape so that the fingers 142 each have a rectangular cross-sectional shape. When the insert 120 is disposed in the cavity 134 of the retainer portion 124, the insert 120 substantially occupies the cross-sectional area of the cavity 134. This enables the fingers 142 to be disposed over a cross-sectional area sufficient to clean the exterior and interior surfaces of a portion of the connector (i.e., the proximal connector 30) inserted into the retainer portion 124, as described in more detail below.
[0080] The connector portion 126 of the scrub cap 116 extends proximally away from the retainer portion 124 and is configured to cooperate with the blood drawing device 14 to fix the scrub cap 116 to the blood drawing device. That is, the connector portion 126 is configured to cooperate with the lock 86 of the blood drawing device 14 so that the connector portion 126 is fixed in place relative to the lock 86.
[0081] The connector portion 126 is generally configured as an elongated protrusion 146 extending outwardly from the base 128 of the retainer portion 124. The protrusion 146 can have a stepped profile, wherein a first portion 148 of the protrusion 146 is positioned adjacent the base 128 and a second portion 150 of the protrusion 146 is positioned proximal to the first portion 148. The first portion 148 of the protrusion 146 is formed to have a first diameter that is greater than a second diameter of the second portion 150. An annular flange 152 can be formed at a transition between the first portion 148 and the second portion 150, wherein the annular flange 152 extends outwardly from the first portion 148 to provide a lip 154. The lip 154 provided by the annular flange 152 can have a depth sufficient to provide engagement therewith by the locking arms 90 of the lock 86, wherein the hooked end 156 of each locking arm 90 engages with a distally facing surface of the lip 154. A pair of retention stops 158 may be formed on the first portion 148 of the protrusion 146 adjacent the distal-facing surface of the annular flange 152. The retention stops 158 are spaced apart to form a retention seat 160 therebetween, wherein the retention seat 160 is sized to receive therein one of the respective locking arms 90 of the lock 86. With the locking arms 90 clamped on the protrusion 146 and engaged with the distal-facing surface of the lip 154, and with one of the locking arms 90 received in the retention seat 160, circumferential displacement of the locking arms 90 about the connector portion 126 is prevented, which may occur, for example, when the blood drawing device 14 is rotated / twisted during cleaning of a connector (e.g., a needleless access connector 30) with the scrub cap 116, as explained in further detail below.
[0082] The second portion 150 of the protrusion 146 includes an opening 162 formed therein at a proximal end 152 of the protrusion 146, the opening 162 providing access to a channel 164 formed within the protrusion 146. The channel 164 can have a cylindrical cross-sectional shape and extend a majority of the length of the protrusion 146, such as to a location adjacent the base 128 of the retainer portion 124. The channel 164 is sized to receive the blunting cannula 88 of the lock 86 on the blood drawing device 14 therein. The blunting cannula 88 can form a press fit or an interference fit with the channel 164 to help secure the lock 86 to the scrub cap 116. In some embodiments, the proximal end of the second portion 150 of the protrusion 146 (and the channel 164 formed therein) tapers outwardly to receive the blunting cannula 88 therein.
[0083] According to one aspect of the present disclosure, the following will describe the use of the scrub cap 116 as a scrubbing device for cleaning and disinfecting the proximal connector 30 of the catheter assembly 12. The use of the scrub cap 116 begins by removing the seal 122 from the scrub cap 116. Figure 8As shown, after removing the seal 122, the user inserts the proximal connector 30 shown above, which can be configured as a female Luer connector having a threaded outer connector 166 defining a tapered lumen or cavity 168, into the foam insert 120. At this point, and as described above with respect to the structure of the insert 120, the fingers 142 of the insert 120 directly below the surface of the insertion portion of the proximal connector 30 are pressed into the retainer portion 124, while the fingers 142 located outside the catheter periphery remain upright and rest on the outer peripheral surface of the proximal connector 30 (i.e., the threaded outer connector 166), and the fingers 142 directly below the lumen 168 of the proximal connector 30 enter the lumen 168. As described above, the individual reaction of the fingers 142 is facilitated by forming the fingers 142 in a finger-like manner to separate from each other.
[0084] Once the portion of the proximal connector 30 is inserted into the foam insert 120 of the scrub cap 116, the scrub cap 116 is rotated relative to the proximal connector 30. For example, the user can hold the proximal connector 30 stationary while rotating the blood drawing device 14. When the scrub cap 116 is locked in place relative to the blood drawing device 14 (by connecting the lock 86 to the scrub cap 116 and retaining one of the locking arms 90 in a retaining seat 160 formed on the scrub cap 116), the rotation of the blood drawing device 14 causes a corresponding rotation of the scrub cap 116. The rotation of the scrub cap 116 relative to the proximal connector 30 can be done entirely in one direction, or can be a back-and-forth twisting motion. The scrub cap 116 is rotated a sufficient number of times relative to the female Luer connector of the proximal connector 30 to fully kill any bacteria that the solution-impregnated foam insert 120 contacts and / or remove any biofilm from the outer peripheral surface of the proximal connector 30 and the threaded outer connector 166 and the inner surface of the lumen 168 of the proximal connector 30. In this manner, both the exterior and interior lumen surfaces of the proximal connector 30 are scrubbed by the various fingers 142 of the insert 120 such that the cleaning material carried by the fingers 142 disinfects the surfaces and removes any biofilm disposed thereon.
[0085] After the cleaning and disinfection of the proximal connector 30 of the catheter assembly 12 is completed by the scrub cap 116, the proximal connector 30 is removed from the scrub cap 116. The scrub cap 116 can then be removed from the blood drawing device 14, wherein such removal is performed by releasing the locking arm 90 from the lip 154 and the retaining seat 160 of the connector portion 126 and by removing the passivation cannula 88 from the channel 164 of the connector portion 126. After allowing the proximal connector 30 to dry, the blood drawing device 14 can then be coupled to the catheter assembly 12 by coupling the lock 86 to the proximal connector 30, i.e., by inserting the passivation cannula 88 into the proximal connector 30 and clamping the locking arm 90 to the proximal connector 30.
[0086] Although the blood drawing device 14 is Figures 1 to 8 1 and 2 are shown and described as including a coupling device 72 in the form of a lock 86 having a blunted cannula 88 and a locking arm 90, but it should be appreciated that the coupling device 72 can be configured as any suitable connection or coupling that allows it to engage with the proximal connector 30 and allow the distal end 104 of the catheter 74 to pass through the coupling device 72 to access the catheter assembly 12. It should also be appreciated that the specific structure of the scrub cap 116 will depend on the configuration of the coupling device 72 in order to provide appropriate engagement and fixation of the scrub cap 116 on the coupling device 72. Described below are a number of alternative structures for the coupling device 72 and the scrub cap 116 according to additional aspects of the present disclosure.
[0087] First reference Fig. 9 and Fig.10 , Fig. 9 and Fig.10 A coupling device 170 and a scrub cap 172 are shown according to an embodiment of the present disclosure. The coupling device 170 includes a proximal end configured as a threaded connector 174 configured to engage with the coupler 84 of the housing 70. The coupling device 170 is configured as a lock 176 that includes an elongated member 178 and a locking arm 180 for coupling to a needleless access connector, wherein the elongated member 178 and the locking arm 180 form three contact points. In this embodiment, the elongated member 178 has a hybrid structure, wherein the elongated member 178 includes a male luer portion 182 and a blunted cannula portion 184. The blunted cannula portion 184 extends distally from the male luer portion 182 and passes through the end of the locking arm 180, wherein the blunted cannula portion 184 has a smaller diameter than the male luer portion 182.
[0088] The scrub cap 172 is similar to the one previously shown in FIG. Figures 5 to 8 146 (and thus like reference numerals are used to identify like parts), except that the structure of the channel 186 formed in the protrusion is different from the previously described channel 164. That is, the channel 186 has a stepped configuration, wherein a first channel portion 188 is formed in the first portion 148 of the protrusion 146 and a second channel portion 190 is formed in the second portion 150 of the protrusion 146. The first channel portion 188 is formed to have a first channel diameter that is less than a second channel diameter of the second channel portion 190, wherein the first channel portion 188 is thus sized to receive the blunted cannula portion 184 of the lock 176 and the second channel portion 190 is thus sized to receive the male luer portion 182. In some embodiments, the proximal end of the second portion 150 of the protrusion 146 (and the second channel portion 190 formed therein) tapers outwardly to receive the male luer portion 182 of the lock 176.
[0089] Next reference Fig.11 and Fig.12 , a coupling device 192 and a scrub cap 194 are shown according to another embodiment of the present disclosure. The coupling device 192 includes a proximal end configured as a threaded connector 196 configured to engage the coupler 84 of the housing 70. The coupling device 192 is configured to include an elongated member 200 and a Luer lock 198 for coupling to an internally threaded ferrule 202 of a needleless access connector. In this embodiment, the elongated member 200 has a hybrid structure, wherein the elongated member 200 includes a male Luer portion 204 and a blunted cannula portion 206. The blunted cannula portion 206 extends distally from the male Luer portion 204, wherein the blunted cannula portion 206 has a smaller diameter than the male Luer portion 204.
[0090] The scrub cap 194 includes a retainer portion 124 that is identical to the previously described scrub caps 116, 172, and includes a connector portion 208. The connector portion 208 is generally configured as an elongated protrusion 210 extending outwardly from the base 128 of the retainer portion 124. The protrusion 210 can have a first portion 212 positioned adjacent to the base 128 and a second portion 214 of the protrusion 210 positioned proximal to the first portion 212. The protrusion 210 can have a generally uniform outer diameter along its length, except that the second portion 214 is configured to have a threaded outer surface 216 that is configured to engage with the internally threaded ferrule 202 of the Luer lock 198, thereby securing the scrub cap 194 to the Luer lock 198 of the coupling device 192.
[0091] The second portion 214 of the protrusion 210 includes an opening 218 formed therein at the proximal end 220 of the protrusion 210, the opening 218 providing access to a channel 222 formed within the protrusion 210. The channel 222 may have a stepped structure, wherein a first channel portion 224 is formed within the first portion 212 of the protrusion 210 and a second channel portion 226 is formed within the second portion 214 of the protrusion 210. The first channel portion 224 is formed to have a first channel diameter that is smaller than a second channel diameter of the second channel portion 226, wherein the first channel portion 224 is thus sized to receive the blunted cannula portion 206 of the Luer lock 198 and the second channel portion 226 is thus sized to receive the male Luer portion 204.
[0092] Next reference Fig.13 and Fig.14 , according to another embodiment of the present disclosure, a coupling device 230 and a scrubbing cap 232 are shown. The scrubbing cap 232 and Fig.11 and Fig.12 The scrub cap 194 is the same as in FIG. 1 and is therefore not described in detail below. The coupling device 230 is substantially the same as in FIG. Fig.11 and Fig.12192, except that the Luer lock 234 of the coupling device 230 includes an internally threaded rotating collar 236 that rotates relative to the elongated member 200 and the remainder of the coupling device 230 for coupling to the needleless access connector (rather than the collar 202 that is fixed to the Luer lock 198 in the coupling device 192). When the coupling device 230 is mated with the scrub cap 232 (or the proximal connector 30), the included rotating collar 236 allows the remainder of the blood drawing device 14 to remain stationary, with only the rotating collar 236 rotating to threadably engage the scrub cap 232.
[0093] Next reference Fig.15 and Fig.16 , a coupling device 240 and a scrub cap 242 are shown according to another embodiment of the present disclosure. The coupling device 240 includes a proximal end configured as a threaded connector 244, which is configured to engage the coupler 84 of the housing 70. The coupling device 240 is configured as a lock 246, which includes an elongated member 248 and a locking arm 250 for coupling to a needleless access connector, wherein the elongated member 248 and the locking arm 250 form three contact points. In this embodiment, the elongated member 248 is configured as a male luer 252.
[0094] The scrub cap 242 is similar to the one previously shown in Figures 9 and 10 140, except that scrub cap 242 cooperates with coupling device 240 in a different manner (as compared to the cooperation of scrub cap 172 with coupling device 174). That is, because elongated member 248 of lock 246 of coupling device 240 includes only male luer 252 (e.g., protrusion) (rather than having a hybrid structure with male luer portion 182 and blunted cannula portion 184 as elongated member 178 does), only second channel portion 190 formed in second portion 150 of protrusion 146 receives elongated member 248 (i.e., male luer 252) of lock 246 therein, while first channel portion 188 in first portion 148 of protrusion 146 remains open.
[0095] Next reference Fig.17 and Fig.18 , according to another embodiment of the present disclosure, a coupling device 254 and a scrubbing cap 256 are shown. The coupling device 254 is similar to Fig.11 and Fig.12 204, and the like. The coupling device 192 of the present invention is shown in FIG. 204, because the coupling device 254 includes a Luer lock 258 having an elongated member 260 and an internally threaded ferrule 262 for coupling to a needleless access connector. However, the elongated member 260 is not a hybrid structure like the elongated member 200 (having a male Luer portion 204 and a blunted cannula portion 206), but the elongated member 260 is constructed as a shortened male Luer 264.
[0096] The scrub cap 256 includes the same retainer portion 124 as the scrub cap previously described, and includes a connector portion 264. The connector portion 264 is generally configured as a shortened protrusion 266 extending outwardly from the base 128 of the retainer portion 124. The protrusion 266 can have a generally uniform outer diameter along its length, and is configured to have a threaded outer surface 268 that is configured to engage with the internally threaded collar 262 of the Luer lock 258, thereby securing the scrub cap 256 to the Luer lock 258 of the coupling device 254. The protrusion 266 includes an opening 270 formed therein at the proximal end of the protrusion 210, which provides access to a channel 272 formed in the protrusion 266. The channel 272 is formed to have a diameter that accommodates the positioning of the male Luer 264 therein.
[0097] Next reference Fig.19 and Fig. 20 , according to another embodiment of the present disclosure, a coupling device 276 and a scrubbing cap 278 are shown. The scrubbing cap 278 is substantially the same as Fig.17 and Fig.18 The scrub cap 256 is the same as in FIG. 1 and is therefore not described in detail below. The coupling device 276 is similar to Fig.13 and Fig.14 204 and 206, because coupling device 276 includes a Luer lock 280 having an elongated member 282 and an internally threaded rotating collar 284 that rotates relative to the elongated member 282 and the remainder of coupling device 276 for coupling to a needleless access connector. However, elongated member 282 does not have a hybrid structure like elongated member 200 (having a male Luer portion 204 and a blunted cannula portion 206), but rather, elongated member 282 is constructed as a shortened male Luer 286.
[0098] Advantageously, embodiments of the present disclosure provide a scrub cap that is integrated with an instrument delivery device and sterilizes a needleless connector or other access port of a peripheral IV catheter prior to connecting the instrument delivery device to the needleless connector or other access port. The scrub cap is configured to securely mate with a coupling device positioned at a distal end of the instrument delivery device and to be removable from the coupling device after sterilizing the needleless connector / access port to provide for subsequent coupling of the instrument delivery device to the needleless connector / access port, thereby enabling advancement of the instrument into the peripheral IV catheter.
[0099] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments or aspects for the purpose of illustration, it should be understood that such detail is only for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but rather, the present disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
Claims
1. An instrument delivery device, characterized in that: The instrument delivery device is coupleable to a catheter assembly including a catheter positionable intravenously within a patient, the instrument delivery device comprising: an instrument configured to be inserted into the catheter; a housing having a proximal end and a distal end and defining an interior volume configured to movably receive the instrument; a coupling device positioned at the distal end of the housing, the coupling device comprising a lock configured to couple the housing to a proximal connector of the catheter assembly; an advancement member configured to move relative to the housing to move the instrument between a first position in which a distal end of the instrument is disposed within the housing or within the lock and a second position in which the distal end of the instrument is disposed within the catheter or beyond a distal tip of the catheter; and a scrub cap engaged with the lock, the scrub cap comprising: Scrub the insert; A housing, the housing of the scrubbing cap comprising: a connector portion configured to engage with the lock to secure the scrub cap to the instrument delivery device, a retainer portion distal to the connector portion and comprising a cavity configured to retain the scrub insert therein; and a seal attached to the retainer portion to seal the scrub insert within the cavity; wherein the scrub cap engages the lock in a manner that allows the scrub cap to be removed from the instrument delivery device.
2. The device delivery device according to claim 1, characterized in that: The connector portion includes a protrusion having a distal end and a proximal end, the distal end of the protrusion being coupled to the connector portion, the proximal end of the protrusion having an opening formed therein, the opening providing access to a passageway formed in the protrusion.
3. The device delivery device according to claim 2, characterized in that: The lock comprises: an elongated member insertable into the channel of the protrusion; and A pair of locking arms are positioned on opposite sides of the elongated member and are engageable with the protrusion.
4. The device delivery device according to claim 3, characterized in that: The protrusion of the connector portion includes: a first portion having a first outer diameter; a second portion positioned proximally of the first portion and having a second outer diameter smaller than the first outer diameter, the second portion including an opening; and an annular flange disposed between the first portion and the second portion and forming a lip; wherein the annular flange is positioned such that when the elongated member is inserted into the passage, the hooked end of each locking arm of the pair of locking arms engages with the lip of the annular flange.
5. The device delivery device according to claim 4, characterized in that: The first part includes a pair of retaining stops, which are formed on the outer surface of the first part and are adjacent to the annular flange. The pair of retaining stops are arranged to form a retaining seat, which receives the hooked ends of the corresponding locking arms of the pair of locking arms, wherein the retaining seat prevents circumferential displacement of the locking arms.
6. The device delivery device according to claim 5, characterized in that: The channel comprises: a first channel portion formed in the first portion of the protrusion; and a second channel portion formed in the second portion of the protrusion; Wherein, the first channel portion has a first channel diameter, and the second channel portion has a second channel diameter greater than the first channel diameter.
7. The device delivery device according to claim 6, characterized in that: The elongated member includes a male luer portion and a blunted cannula portion extending distally therefrom, wherein the blunted cannula portion is sized to fit within the first channel portion and the male luer portion is sized to fit within the second channel portion.
8. The device delivery device according to claim 6, characterized in that: The elongate member includes a male luer connector sized to fit within the second channel portion, and wherein the first channel portion remains open when the elongate member is inserted into the channel.
9. The instrument delivery device according to claim 2, characterized in that: The lock comprises: an elongated member insertable into the channel of the protrusion; and A ferrule is positioned about the elongated member and includes a threaded inner surface.
10. The device delivery apparatus according to claim 9, wherein: The protrusion of the connector portion includes a threaded outer surface configured to engage the threaded inner surface of the ferrule to secure the scrub cap to the lock.
11. The device delivery device according to claim 10, characterized in that: The elongate member includes a male luer connector sized to fit within the passageway.
12. The device delivery device according to claim 10, characterized in that: The protrusion of the connector portion includes: Part I; and a second portion, the second portion being positioned proximal to the first portion, the second portion comprising the opening; Wherein, the threaded outer surface is formed on the second portion.
13. The device delivery device according to claim 12, characterized in that: The channel comprises: a first channel portion formed in the first portion of the protrusion; and a second channel portion formed in the second portion of the protrusion; Wherein, the first channel portion has a first channel diameter, and the second channel portion has a second channel diameter greater than the first channel diameter.
14. The device delivery device according to claim 13, wherein: The elongated member includes a male luer portion and a blunted cannula portion extending distally therefrom, wherein the blunted cannula portion is sized to fit within the first channel portion and the male luer portion is sized to fit within the second channel portion.
15. The device delivery device according to claim 11, characterized in that: The cavity in the retainer portion and the scrubbing insert are sized and reconfigured to receive a female Luer connection of the proximal connector of the catheter assembly.