Drug Delivery Assembly

Abstract

To provide a drug transfer assembly including a connector connectable to a portion of an intravenous injection line and an adapter cap removably connectable with the connector.SOLUTION: A first connector 14 is formed of a rigid material and an adapter cap 30 is formed of a pliable material. By connecting both of them, the adapter cap protectively surrounds and shields the first connector. The adapter cap provides a cushioning surface which prevents rubbing of the first connector against the skin of a patient. In this manner, the adapter cap prevents the first connector of a drug transfer assembly 10 from causing irritation and / or infection to the skin of a patient. Furthermore, the adapter cap provides a protective shield which prevents the first connector of the drug transfer assembly from becoming contaminated with undesirable substances.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to drug transfer assemblies. In particular, the present disclosure relates to an adapter cap that protectively surrounds and shields a connector to provide a leak-proof seal throughout the drug transfer procedure.

[0002] Personal intravenous therapy applications allow patients to receive infusions and medications at home. For example, home therapy can include administering medications via IV, using intravenous and subcutaneous or subcutaneous routes, i.e., into the bloodstream and beneath the skin. Medications that personal intravenous therapy applications can provide to patients include antibiotics, pain management medications, cancer medications, and similar medications. Personal intravenous therapy applications can enable more cost-effective medical care and reduce the duration of an in-patient hospital stay. Additionally, returning patients to their homes and families can promote faster recovery and improve a patient's quality of life. Summary of the Invention [Problem to be solved by the invention]

[0003] In such applications, the drug delivery device stores the medication until it is needed by the user. For example, a syringe may contain the medication required by the user. The patient is provided with a personal intravenous system, which may include intravenous tubing and a connector adapted to receive an injector and / or syringe containing the required medication. In this manner, when treatment is required, the user can connect the syringe assembly to the connector and then administer the medication intravenously via the injector and / or syringe assembly, the connector, and the intravenous tubing. However, the connector of the personal intravenous system used by the patient may cause irritation to the patient's skin due to its hard material and / or sharp edges. [Means for solving the problem]

[0004] The present disclosure provides a drug transfer assembly including a connector for connection to a portion of an intravenous line adapted for connection to a patient's bloodstream and an adapter cap removably connectable to the connector. The connector is formed of a rigid material, and the adapter cap is formed of a pliable material. By connecting the adapter cap to the connector, the adapter cap protectively surrounds and shields the connector. The adapter cap provides a cushioning surface that prevents the connector from rubbing against the patient's skin. This allows the adapter cap to prevent the connector of the drug transfer assembly from causing irritation and / or infection to the patient's skin. Additionally, the adapter cap provides a protective shield that prevents undesirable substances from contaminating the connector of the drug transfer assembly.

[0005] In an embodiment of the invention, a drug transfer assembly includes an intravenous line adapted for connection to a patient's bloodstream and a connector connected to a portion of the intravenous line, the connector having a connector material hardness. The drug transfer assembly also includes a syringe containing a medication that is removably connectable to the connector, and an adapter cap removably connectable to the connector, the adapter cap having a material hardness that is less than the connector material hardness. When the syringe is connected to the connector, the connector provides a closed connection for the syringe and the intravenous line, allowing the syringe to be in fluid communication with the intravenous line through the connector to inject medication into the patient's bloodstream, and when the adapter cap is connected to the connector, the adapter cap protectively surrounds the connector.

[0006] In one configuration, the connector comprises a rigid material and the adapter cap comprises a flexible material. In one configuration, the IV line comprises flexible tubing. In another configuration, the injector comprises a syringe assembly. In one configuration, the drug delivery system further comprises a second connector connected to a second portion of the IV line, the second connector being adapted to receive an IV bag containing a second medication. In another configuration, the adapter cap comprises a thermoplastic elastomer. In yet another configuration, the adapter cap comprises a thermoset elastomer. In one configuration, the adapter cap can have a hardness ranging from Shore A5 to Shore A50. In another configuration, the adapter cap can have a hardness ranging from Shore A20 to Shore A40.

[0007] In another embodiment of the present invention, a drug transfer assembly includes an intravenous line adapted for connection to a patient's bloodstream, a connector connected to a portion of the intravenous line and having a connector material hardness, and an adapter cap removably connectable to the connector, the adapter cap having an adapter cap material hardness that is less than the connector material hardness.

[0008] In one configuration, the drug transfer assembly includes a medication-containing injector removably connectable to the connector. In another configuration, when the injector is connected to the connector, the connector provides a closed connection for the injector and the IV line, allowing the injector to be in fluid communication with the IV line through the connector to inject medication into the patient's bloodstream, and an adapter cap is connected to the connector, protectively enclosing at least a portion of the connector. In a further configuration, the connector includes a rigid material and the adapter cap includes a flexible material. In one configuration, the IV line includes flexible tubing.

[0009] When the adapter cap is connected to the connector, the adapter cap protectively surrounds at least a portion of the connector. In other configurations, the connector comprises a hard material and the adapter cap comprises a soft material. In further configurations, the adapter cap can have a hardness ranging from Shore A5 to Shore A50. In one configuration, the adapter cap can have a hardness ranging from Shore A20 to Shore A40.

[0010] The above and other features and advantages of the present disclosure, as well as the manner in which they are realized, will become more apparent, and the disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is an assembled perspective view of a drug delivery assembly according to one embodiment of the present invention; FIG. [Figure 2A] FIG. 1 is an exploded perspective view of a connector and adapter cap of a drug transfer assembly according to one embodiment of the present invention. [Figure 2B] 2B is a perspective view showing the connector according to the embodiment of the present invention in an assembled state with an adapter cap connected thereto, as compared to FIG. 2A. [Figure 3]2 is a perspective view of the drug delivery assembly of FIG. 1, illustrating application of the drug delivery assembly to a patient in accordance with one embodiment of the present invention. [Figure 4] 4 is an exploded perspective view of the drug transfer assembly of FIG. 3, showing an adapter cap connected to a connector of the drug transfer assembly removed in accordance with one embodiment of the present invention. [Figure 5] 4 is a perspective view of the drug delivery assembly of FIG. 3, showing an injector connected to the connector of the drug delivery assembly in accordance with one embodiment of the present invention. [Figure 6A] FIG. 1 is a perspective view of an adapter cap of a drug transfer assembly according to one embodiment of the present invention. [Figure 6B] FIG. 6B is a top view of the adapter cap of the drug transfer assembly shown in FIG. 6A in accordance with one embodiment of the present invention. [Figure 6C] FIG. 6B is a front view of the adapter cap of the drug transfer assembly shown in FIG. 6A in accordance with one embodiment of the present invention. [Figure 6D] FIG. 6B is a side view of the adapter cap of the drug transfer assembly shown in FIG. 6A in accordance with one embodiment of the present invention. [Figure 6E] FIG. 6B is a bottom view of the adapter cap of the drug transfer assembly shown in FIG. 6A in accordance with one embodiment of the present invention. [Figure 6F] FIG. 6F is a cross-sectional view of the adapter cap of the drug transfer assembly shown in FIG. 6B along line 6F-6F according to one embodiment of the present invention. [Figure 7A] FIG. 1 is a perspective view of an adapter cap of a drug transfer assembly according to one embodiment of the present invention. [Figure 7B] FIG. 7B is a bottom view of the adapter cap of the drug transfer assembly shown in FIG. 7A in accordance with one embodiment of the present invention. [Figure 7C] FIG. 6B is a side view of the adapter cap of the drug transfer assembly shown in FIG. 6A in accordance with one embodiment of the present invention. [Figure 7D] FIG. 7B is a top view of the adapter cap of the drug transfer assembly shown in FIG. 7A according to one embodiment of the present invention. [Figure 7E]FIG. 7E is a cross-sectional view of the adapter cap of the drug transfer assembly shown in FIG. 7B along line 7E-7E according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The examples described herein are exemplary embodiments of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any way.

[0013] The following description is provided to enable one skilled in the art to make and use the described embodiments considered to practice the invention. However, those skilled in the art will readily recognize that various modifications, equivalents, changes, and alternatives are possible. Any and all such modifications, equivalents, changes, and alternatives are intended to be within the spirit and scope of the invention.

[0014] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will be used to refer to the present invention as orientations in the drawings. However, the present invention contemplates various alternatives unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following description are merely exemplary embodiments. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0015] 1-5, drug delivery assembly 10 includes an IV line 12 adapted for connection to the bloodstream of a patient P. Drug delivery assembly 10 further includes a patient portion 13 of IV line 12, a first connector 14 connected to a first portion 16 of IV line 12, a second connector 18 connected to a second portion 20 of IV line 12, an IV line connector 22 connecting patient portion 13 of IV line 12 in fluid communication with first portion 16 and second portion 20 of IV line 12, a patient connector 24 disposed at a patient end 26 of IV line 12, and an adapter cap 30 removably connectable to first connector 14.

[0016] 1-5, in one embodiment, IV line 12 can include sections of flexible plastic tubing. The sections of plastic tubing can be connected in fluid communication by IV line connector 22. In one embodiment, IV line connector 22 can have a Y-shape, as shown in FIG. 1. In other embodiments, IV line connector 22 can have a T-shape, as shown in FIGS. 3-5. It is further contemplated that IV line connector 22 can be fabricated in various shapes and sizes utilized to accommodate the sections of plastic tubing, such that first connector 16 and second connector 18 are positioned a distance from one another.

[0017] In one embodiment, first connector 14 is a Becton Dickinson ("BD") PhaSeal, available from Becton, Dickinson and Company of Franklin Lakes, New Jersey (the assignee of the present invention). TM In other embodiments, first connector 14 comprises a connector compatible with other occlusive drug delivery devices.

[0018] In one embodiment, second connector 18 comprises an IV bag connector suitable for receiving an IV bag containing a second medication. In one embodiment, second connector 18 comprises a Becton Dickinson ("BD") PhaSeal® bag connector suitable for receiving an IV bag containing a second medication. TM In other embodiments, second connector 18 comprises a connector compatible with other occlusive drug delivery devices.

[0019] The drug delivery assembly 10 of the present disclosure can be used in connection with personal intravenous therapy applications, allowing patients to receive infusions and medications at home. However, the drug delivery assembly 10 can also be used in other situations. Home therapy can include administering medications via IV using intravenous and subcutaneous or subcutaneous routes, i.e., into the bloodstream and beneath the skin. Examples of medications that a personal intravenous therapy application can provide to a patient include antibiotics, pain management medications, cancer medications, and similar medications.

[0020] The medication may be packaged as a "pre-filled" device, where the syringe assembly is pre-filled with the medication prior to packaging and delivery to the patient. A "pre-filled" device eliminates the need for the user to fill the device prior to injection.

[0021] Certain drugs or agents are preferably provided in powder or dry form (e.g., lyophilized form) and therefore require reconstitution prior to administration. Lyophilized drugs, for example, are typically supplied in lyophilized form and must be mixed with a diluent to reconstitute the material into a form suitable for injection. In addition, drugs may be provided as multipart systems that require mixing prior to administration. For example, one or more liquid components, such as a flowable slurry, and one or more dry components, such as powdered or granular components, may be provided in separate containers and must be mixed prior to administration.

[0022] Referring to FIG. 5, drug delivery assembly 10 includes an injector 40 removably connectable to first connector 14 and a syringe assembly 42 containing a drug or fluid 44. Drug 44 may be packaged in syringe assembly 42 as a "pre-filled" device, or drug 44 may be a reconstituted drug as described above. Once drug 44 is contained in syringe assembly 42, it is ready to be administered into the bloodstream of a patient, such as patient P (FIGS. 3-5). When the patient is ready to receive the drug, the patient removes adapter cap 30 (FIG. 4) from first connector 14, as described in more detail below.

[0023] Referring to FIG. 5 , patient P may then connect an injector 40 to first connector 14, which is connected to first portion 16 of intravenous line 12 of drug transfer assembly 10. A syringe assembly 42 may then be connected to injector 40. In one embodiment, injector 40 and syringe assembly 42 may be a single component connected to first connector 14. By connecting injector 40 to first connector 14, first connector 14 provides a secure, closed connection to injector 40 and syringe assembly 42, thereby providing a leak-proof seal throughout the drug transfer procedure. Furthermore, first connector 14 fluidly connects injector 40 and syringe assembly 42 to intravenous line 12, as shown in FIG. 5 . In this manner, patient P may inject medication 44 into his or her bloodstream. In such an embodiment, the drug 44 can be injected from the syringe assembly 42 through the injector 40 to the first connector 14, from the first portion 16 of the IV line 12 through the IV line connector 22 to the patient portion 13, and then through the patient connector 24 at the patient end 26 of the IV line 12 into the bloodstream of the patient P in a secure, leak-free closed connection, i.e., in a manner that prevents the ingress of external contaminants into the drug transfer assembly 10 and prevents leakage of the drug during movement through the above-mentioned flow path.

[0024] Once a dose of medication has been administered, the injector 40 and syringe assembly 42 are removed from the first connector 14. In this configuration, the first connector 14 is connected to the first section 16 of the intravenous line 12, as shown in FIG. 3 . A patient using the drug transfer assembly may need to carry the drug transfer assembly 10, along with the first connector 14, on their body. This can result in the first connector 14, formed from a hard material having a hardness, contacting areas of the patient's skin, potentially resulting in irritation and / or infection. In one exemplary embodiment, the first connector 14 is made from a material having a hardness greater than the hardness of the adapter cap material. For example, the first connector 14 can be made from thermoset or thermoplastic polymers, such as polypropylene, polyethylene, polycarbonate, acrylics, nylons, or similar materials. Additionally, the first connector 14 may include sharp edges, which may contact areas of the patient's skin, potentially resulting in irritation and / or infection. Additionally, exposure of the first connector 14 to the environment can cause the first connector 14 to become contaminated with undesirable substances.

[0025] To eliminate the above-mentioned disadvantages of the drug delivery assembly, as shown in Figure 3, when the patient has finished administering a dose of medication, the adapter cap 30 of the present disclosure is connected to the first connector 14. In this manner, the adapter cap 30 protectively surrounds and shields the first connector 14, preventing contact between the first connector 14 and the patient's skin and preventing contamination of the first connector 14 of the drug delivery assembly 10.

[0026] 6A-6F illustrate an adapter cap 30A according to an exemplary embodiment of the present disclosure. The adapter cap 30A generally includes an adapter body 50 defining an outer adapter wall 52 and an inner adapter wall 54 corresponding to the outer and inner contours, respectively, of the adapter cap 30A. Referring to FIG. 6F, the inner wall 54 defines a cavity 56 that is sized and shaped to receive the first connector 14 via an interference-fit connection, as described below. The adapter body 50 generally includes a frustoconical tapered portion 58, a first cylindrical portion 60, a second cylindrical portion 62, and an arcuate or curved edge 64. In this manner, the adapter cap 30A is free of any sharp edges.

[0027] The adapter body 50 of the exemplary embodiment is preferably made of a flexible material, such as soft rubber or flexible plastic. In one exemplary embodiment, the adapter body 50 is made of a thermoplastic elastomer, such as styrene block copolymers, polyolefin blends and alloys, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic polyamides, or similar materials. In other embodiments, the adapter body 50 is made of a thermoset elastomer (rubber), such as silicone, polyisoprene, neoprene, or similar materials. The adapter body 50 can be injection molded using TPE elastomers or liquid rubber, or injected or cast using silicones. The hardness of the flexible material forming the adapter cap 30A, i.e., the adapter cap material hardness, is sufficient to provide a cushioning surface for the adapter outer wall 52, for example, to prevent irritation to the patient's skin while the patient is holding the drug delivery assembly. Furthermore, the adapter cap material hardness is less than the first connector material hardness of the material forming the first connector 14.

[0028] In one embodiment, the adapter cap material hardness of the material forming the adapter cap 30A may have a hardness value in the Type A range on the Shore Durometer scale for rubbers and softer plastics. In one exemplary embodiment, the adapter cap 30A may have a hardness ranging from Shore A5 to Shore A50. In another exemplary embodiment, the adapter cap 30A may have a hardness ranging from Shore A20 to Shore A40.

[0029] In one embodiment, the first connector material hardness of the material forming the first connector 14 may have a hardness value on the Shore Durometer scale in the Type D range for relatively hard plastics. In one exemplary embodiment, the first connector 14 may have a hardness ranging from Shore D40 to Shore D100. In another exemplary embodiment, the first connector 14 may have a hardness ranging from Shore D50 to Shore D80.

[0030] In one embodiment, adapter cap 30A is a Becton Dickinson ("BD") PhaSeal™ adapter cap available from Becton, Dickinson and Company, Franklin Lakes, New Jersey, the assignee of the present invention. TM In other embodiments, adapter cap 30A is compatible with other closed system drug transfer devices.

[0031] 2A and 2B, in an exemplary embodiment, the adapter cap 30 and the first connector 14 are secured to one another by an interference-fit connection to provide a tight fit therebetween, such that the adapter cap 30 protectively surrounds and shields the first connector 14, preventing contact between the first connector 14 and the patient's skin and preventing contamination of the first connector 14 of the drug transfer assembly 10. The adapter cap 30 as shown in FIGS. 2A and 2B is similar to the adapter cap 30B as shown in FIGS. 7A-7E, although the adapter cap 30A can be secured to the first connector 14 in a similar manner.

[0032] 2A, 2B, 6A-6F, and 7A-7E, adapter body 50 of adapter cap 30A and adapter body 70 of adapter cap 30B are each sized and shaped to correspond to outer contour 15 of first connector 14. The interference fit between adapter caps 30A, 30B and first connector 14 is achieved by sizing and shaping the two mating parts, i.e., the inner contour of adapter body 50 of adapter cap 30A (or the inner contour of adapter body 70 of adapter cap 30B) and the outer contour 15 of first connector 14, such that the inner contour of adapter body 50 of adapter cap 30A is slightly dimensionally offset from the outer contour 15 of first connector 14. This ensures a tight fit, and the adapter body 50 of adapter cap 30A (or adapter body 70 of adapter cap 30B) and the first connector 14 are secured to each other by frictional forces after the first connector 14 is inserted into the selected adapter cap 30.

[0033] 7A-7E illustrate an adapter cap 30B according to another exemplary embodiment of the present disclosure. The adapter cap 30B generally includes an adapter body 70 defining an outer adapter wall 72 and an inner adapter wall 74 corresponding to the outer and inner contours, respectively, of the adapter cap 30B. Referring to FIG. 7E, the inner wall 74 defines a cavity 76 sized and shaped to receive the first connector 14 via an interference fit connection as described above. The adapter body 70 generally includes an arcuate portion 78, a first cylindrical portion 80, a second cylindrical portion 82, and an arcuate or curved edge 84. In this manner, the adapter cap 30B is free of any sharp edges.

[0034] The adapter body 70 of the exemplary embodiment is preferably made of a flexible material, such as soft rubber or flexible plastic. In one exemplary embodiment, the adapter body 50 is made of a thermoplastic elastomer, such as styrene block copolymers, polyolefin blends or alloys, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic polyamides, or similar materials. In other embodiments, the adapter body 70 is made of a thermoset elastomer (rubber), such as silicone, polyisoprene, neoprene, or similar materials. The adapter body 70 can be injection molded using TPE elastomers or liquid rubber, or injected or cast using silicones. The hardness of the flexible material forming the adapter cap 30B, i.e., the adapter cap material hardness, is sufficient to provide a cushioning surface for the adapter outer wall 72, for example, to prevent irritation to the patient's skin while the patient is carrying the drug delivery assembly. Furthermore, the adapter cap material hardness is less than the first connector material hardness of the material forming the first connector 14.

[0035] In one embodiment, the adapter cap material hardness of the material forming the adapter cap 30B may have a hardness value in the Type A range on the Shore Durometer scale for rubbers and relatively soft plastics. In one exemplary embodiment, the adapter cap 30B may have a hardness ranging from Shore A5 to Shore A50. In another exemplary embodiment, the adapter cap 30B may have a hardness ranging from Shore A20 to Shore A40.

[0036] In one embodiment, the first connector material hardness of the material forming the first connector 14 may have a hardness value on the Shore Durometer scale in the Type D range for harder plastics. In one exemplary embodiment, the first connector 14 may have a hardness ranging from Shore D40 to Shore D100. In another exemplary embodiment, the first connector 14 may have a hardness ranging from Shore D50 to Shore D80.

[0037] In one embodiment, adapter cap 30B is a Becton Dickinson ("BD") PhaSeal™ adapter cap available from Becton, Dickinson and Company, Franklin Lakes, New Jersey, the assignee of the present invention. TM In other embodiments, adapter cap 30A is compatible with other closed system drug transfer devices.

[0038] The adapter caps 30A, 30B may be packaged separately from the other components of the drug transfer assembly 10. In other embodiments, the adapter caps 30A, 30B may be "packaged" so that they are pre-attached to the first connector 14 of the drug transfer assembly.

[0039] While this disclosure has been described as having an exemplary design, the disclosure can be further modified within the spirit and scope of the disclosure. Accordingly, this application is intended to cover any variations, uses, and adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains and fall within the limits of the appended claims.

Claims

1. 1. An adapter cap and connector arrangement for a drug transfer assembly, comprising: a connector having a connector material hardness; and an adapter cap removably connectable with the connector, the adapter cap having an adapter cap material hardness, the adapter cap material hardness is lower than the connector material hardness, the adapter cap has an outer wall defined by an opening, a first cylindrical portion, a second cylindrical portion, and an arcuate or curved edge, and the adapter cap outer wall is free of sharp edges; The adapter cap has inner diameters of the opening, the second cylindrical portion, and the first cylindrical portion that change from the opening toward the back of the cap, the first cylindrical portion having a first inner diameter that is larger than the inner diameter of the opening, and the second cylindrical portion having a second inner diameter that is smaller than the first inner diameter and larger than the inner diameter of the opening, the connector having a first connector cylindrical portion with a first connector outer diameter and a second connector cylindrical portion with a second connector outer diameter that is smaller than the outer diameter of the first connector cylindrical portion, and the adapter cap is attached to the connector.

10. An adapter cap and connector arrangement, wherein, in a connected state, the first connector cylindrical portion is received in the first cylindrical portion and the second connector cylindrical portion is received in the second cylindrical portion, the adapter cap and the connector are secured to one another by an interference fit connection, and the first cylindrical portion, the second cylindrical portion, and an outer wall of the adapter cap defined by an arcuate or curved edge cooperate to protectively surround and shield the connector, prevent contact between the connector and a patient's skin, and protectively shield the connector from contamination.

2. 10. The adapter cap and connector arrangement of claim 1, wherein the connector comprises a hard material and the adapter cap comprises a flexible material.

3. 2. The adapter cap and connector arrangement of claim 1, wherein the adapter cap has a hardness ranging from Shore A5 to Shore A50.

4. 2. The adapter cap and connector arrangement of claim 1, wherein the adapter cap has a hardness ranging from Shore A20 to Shore A40.

5. 2. The adapter cap and connector arrangement of claim 1, wherein the adapter cap has a frustoconical tapered portion.

6. 4. The adapter cap and connector arrangement of claim 3, wherein the connector has a hardness ranging from Shore D40 to Shore D100.

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