Bottle adapter with universal connector

Abstract

A vial adapter includes: a body having a component connection interface; a piercing member having a first end connected to the body and a second end positioned opposite the first end, where the piercing member and the body define a fluid passage in fluid communication with the component connection interface; and a bottle body fixing member extending from the main body. The bottle body fixing member is configured to fix the main body to the bottle body. The bottle body fixing component can move between a first position and a second position, and in the first position, the bottle body fixing component limits a first length and a first width; in the second position, the bottle fixing member has a second length and a second width, where the first length is greater than the first width, the first length is greater than the second length, and the second width is greater than the first width.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Patent Application No. 18 / 477,847, filed on September 29, 2023, entitled “Vial Adapter with Universal Connection,” the disclosure of which is incorporated herein by reference in its entirety.

[0002] Technical Field

[0003] This invention relates to a bottle adapter with a universal bottle connector.

[0004] Existing technology The reconfiguration, transportation, and administration of hazardous medications (e.g., cancer treatments) by healthcare providers can expose them to these medications and pose a hazard to the healthcare environment. Unintentional chemotherapy exposure can affect the nervous system, damage the reproductive system, and increase the risk of future blood cancers. Some medications require dissolution or dilution before administration, which involves transferring the solvent from a container to a sealed vial containing the medication in powder or liquid form. If any pressure difference exists between the inside of the vial and the surrounding atmosphere, the medication may be inadvertently released into the atmosphere as a gas or aerosol during the removal of the vial. To reduce the risk of healthcare providers' exposure to toxic medications, the transfer of these medications is accomplished using a closed system transfer device or system.

[0005] A bottle adapter for accessing a vial or container utilizes a piercing member that penetrates the container's sealing member and defines an opening at its distal end. Typically, after the piercing member is inserted into the vial, the vial is inverted to remove the medication from the container. Such a device may also include a pressure equalization device to prevent pressurization of the container or the creation of a vacuum within the container, which could deform the container and increase the risk of medication entering the surrounding environment. Before withdrawing liquid medication from the container, air can be introduced into a syringe that can be attached to a syringe adapter by pulling back the plunger of the syringe. The air in the syringe is pushed into the container through the vial adapter, causing the pressure equalization device to expand. The liquid medication is then withdrawn, where the air in the pressure equalization device replaces the fluid within the container to maintain pressure within the container.

[0006] Drug containers (typically bottles) come in various sizes and dimensions. Because bottle adapters are positioned on the bottle's closure, and bottles come with closures of various sizes, a variety of bottle adapter sizes are required to accommodate bottles of different sizes. Providing bottle adapters of various sizes to healthcare providers increases inventory management and workflow complexity. Summary of the Invention

[0007] In one aspect or embodiment, the bottle adapter includes: a body having a component connection interface configured to engage a connection interface of a mating component; a piercing member having a first end and a second end, the first end being connected to the body and the second end being positioned opposite the first end, wherein the piercing member and the body define a fluid passage in fluid communication with the component connection interface; and a bottle fixing member extending from the body. The bottle fixing member is configured to fix the body to a bottle, wherein the bottle fixing member is movable between a first position and a second position, in which the bottle fixing member defines a first length and a first width, and in a second position, the bottle fixing member has a second length and a second width. The first length is greater than the first width, the first length is greater than the second length, and the second width is greater than the first width.

[0008] The bottle adapter may further include a pressure balancing assembly having a balancing housing and an expandable member, wherein the balancing housing and the expandable member define a space configured to expand from a first volume to a second volume, the second volume being larger than the first volume. The balancing housing defines a balancing opening in fluid communication with the space, wherein a piercing member defines a pressure balancing channel in fluid communication with the balancing opening.

[0009] The bottle-holding member may be annular. It may be flexible and configured to be reshaped by a healthcare professional to move between a first position and a second position. The bottle-holding member may define an ellipse, wherein the major axis of the ellipse corresponds to a first length and a second length, and the minor axis of the ellipse corresponds to a first width and a second width. The bottle-holding member may be connected to the body via a first arm and a second arm. The bottle-holding member may be axially spaced from the body.

[0010] The bottle adapter may also include a locking member configured to lock the bottle retaining member in a second position. The bottle retaining member may define a first opening and a second opening, wherein the locking member extends through the first opening and the second opening of the bottle retaining member. The locking member may be a cable tie.

[0011] The component connection interface may include a diaphragm and can be configured to mate with a syringe adapter. The body and the balancing housing may be formed separately.

[0012] In another aspect or embodiment, the bottle adapter includes: a body having a component connection interface configured to engage a connection interface of a mating component; a piercing member having a first end and a second end, the first end being connected to the body and the second end positioned opposite the first end, wherein the piercing member and the body define a fluid passage in fluid communication with the component connection interface; and a bottle retaining member extending from the body, wherein the bottle retaining member is configured to secure the body to a bottle. The bottle retaining member is cycloidal in shape and defines curved sides, wherein the curved sides of the bottle retaining member are configured to expand radially to receive a first bottle having a first diameter and a second bottle having a second diameter. The second diameter is larger than the first diameter. Attached Figure Description

[0013] Figure 1 This is a perspective view of a bottle adapter according to one aspect or embodiment of this application; Figure 2A yes Figure 1 A perspective view of the bottle adapter, showing the bottle adapter connected to the bottle; Figure 2B yes Figure 1 A partial sectional view of the bottle adapter; Figure 3 yes Figure 1 A perspective view of the bottle adapter, showing the bottle adapter connected to the bottle; Figure 4 yes Figure 1 A partial perspective view of the bottle adapter, showing the bottle adapter connected to the bottle; Figure 5 yes Figure 1 A partial perspective view of the bottle adapter, showing the bottle adapter connected to the bottle; Figure 6 yes Figure 1 A bottom view of the bottle adapter, showing the steps for attaching the bottle adapter to the bottle; Figure 7 yes Figure 1 A bottom view of the bottle adapter shows another step in attaching the bottle adapter to the bottle; Figure 8 yes Figure 1 A bottom view of the bottle adapter, showing the bottle adapter connected to the bottle; Figure 9 yes Figure 1 A bottom view of the bottle adapter, showing the bottle adapter connected to the bottle via a fixing member; Figure 10This is a bottom view of a bottle adapter according to another aspect or embodiment, showing the bottle adapter being fixed to a first-sized bottle; Figure 11 yes Figure 10 A bottom view of the bottle adapter shows the bottle adapter being attached to a second-sized bottle; and Figure 12 yes Figure 10 The bottom view of the bottle adapter shows the bottle adapter being attached to a third-size bottle. Detailed Implementation

[0014] In the following description, for descriptive purposes, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that, unless explicitly stated to the contrary, the invention may take various alternative variations and sequences of steps. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific sizes and other physical features associated with the embodiments disclosed herein should not be considered limiting. Furthermore, it should be understood that, unless explicitly stated to the contrary, the invention may take various alternative variations and sequences of steps.

[0015] refer to Figures 1 to 7 According to one aspect or embodiment, the bottle adapter 10 includes a body 12, a puncture member 14, and a bottle retaining member 16. The bottle adapter 10 is a component of a closed-system transfer device and is used to facilitate the transfer of medication from the bottle to another container or component (e.g., a syringe connected to a syringe adapter (not shown)) while preventing the release of medication from the bottle 18 into the surrounding environment. The bottle 18 may be a container with a punctureable closure 20 and a neck 22, such as a glass or polymer container, but the bottle 18 may be any other suitable container typically used for drug transfer.

[0016] Refer again Figures 1 to 7The body 12 has a component connection interface 24 configured to engage a connection interface of a mating component (e.g., a syringe adapter). In one aspect or embodiment, the component connection interface 24 includes a diaphragm 26 and is configured to mate with a syringe adapter. The component connection interface 24 may be the same as and operate in the same manner as the connection interface shown in Figures 20 and 21 of U.S. Patent Application Publication No. 2018 / 0200147. The piercing member 14 has a first end 28 and a second end 30, the first end 28 being connected to the body 12 and the second end 30 being positioned opposite the first end 28, wherein the piercing member 14 and the body 12 define a fluid passage 32 in fluid communication with the component connection interface 24. In one aspect or embodiment, at least a portion of the piercing member 14 is covered by a retractable sleeve (not shown). This retractable sleeve may be the same as the retractable sleeve shown and described in U.S. Patent No. 9,919,826. A bottle-fixing member 16 extends from the main body 12, wherein the bottle-fixing member 16 is configured to fix the main body 12 to the bottle body 18. For example... Figure 6 and Figure 7 As shown, the bottle fixing member 16 can be in the first position (e.g. Figure 6 (as shown) and the second position (as shown) Figure 7 The bottle body fixing member 16 moves between (as shown), in a first position, defining a first length L1 and a first width W1, and in a second position, having a second length L2 and a second width W2. The first length L1 is greater than the first width W1, the first length L1 is greater than the second length L2, and the second width W2 is greater than the first width W1. In one aspect or embodiment, the ratio of the first length L1 to the first width W1 is between 2.0 and 3.0. In one aspect or embodiment, the ratio of the first length L1 to the first width W1 is between 2.0 and 2.5. In one aspect or embodiment, the ratio of the first length L1 to the first width W1 is 2.14.

[0017] In one aspect or embodiment, the bottle retaining member 16 is configured to be grasped and deflected by a healthcare worker to move the bottle retaining member 16 from a first position (e.g., Figure 6 (As shown) Move to the second position (as shown) Figure 7As shown, the bottle retaining member 16 can accommodate bottles of various sizes and dimensions. In other words, the bottle retaining member 16 can be deflected or opened to the extent required to allow it to receive the bottle 18 and secure the bottle adapter 10 to it. Due to the elasticity of the bottle retaining member 16, it is configured to return to a first position, positioning it at the neck 22 of the bottle 18 below the closure 20, thereby securing the bottle adapter 10 to the bottle 18. In one aspect or embodiment, the bottle retaining member 16 is configured to provide a clamping force of 15 N to secure the bottle adapter 10 to the bottle 18. In another aspect or embodiment, the bottle retaining member 16 is configured to provide a clamping force of 20 N to secure the bottle adapter 10 to the bottle 18. In one aspect or embodiment, the thickness of the bottle fixing member 16 is 1.6 mm or 2.0 mm to provide a clamping force of 15 N or 20 N, respectively.

[0018] refer to Figure 2A and Figure 2B In some aspects or embodiments, the bottle adapter 10 further includes a pressure balancing assembly 34 having a balancing housing 36 and an expandable member 38, wherein the balancing housing 36 and the expandable member 38 define a space 40 configured to expand from a first volume to a second volume, the second volume being larger than the first volume. In some aspects or embodiments, the expandable member 38 is a thin film attached to the balancing housing 36, the film being configured to expand and contract. The balancing housing 36 defines a balancing opening 42 in fluid communication with the space 40, and the piercing member 14 defines a pressure balancing channel 44 in fluid communication with the balancing opening 42. The pressure balancing assembly 34 is configured to balance the pressure within the bottle 18 during fluid transfer by using the pressure balancing channel 44, the balancing opening 42, and the expandable member 38. The pressure balancing channel 44 is in fluid communication with the space 40 such that air or fluid introduced into the bottle 18 using the bottle adapter 10 will replace the air within the bottle 18 and expand the expandable member 38 from the first volume to the second volume. Specifically, during the use of the bottle adapter 10, the pressure equalization component 34 is used to regulate the pressure inside the bottle 18 and to contain the drug and any vapors therefrom within the bottle adapter 10 and the bottle 18.

[0019] Refer again Figures 1 to 7The bottle retainer 16 is annular, but other suitable shapes, such as multiple spaced-apart arcuate segments, may also be used. As described above, the bottle retainer 16 is flexible and configured to be reshaped by a healthcare professional to move between a first position and a second position. The flexibility of the bottle retainer 16 may be provided by the material (e.g., a polymer) and / or the shape and size of the bottle retainer. In one aspect or embodiment, the bottle retainer 16 is formed of a polymer, such as a polypropylene homopolymer, and particularly may be the Bormed™ HD850MO polymer available from the Borealis Group. In one aspect or embodiment, as shown, the bottle retainer 16 defines an ellipse, wherein the major axis of the ellipse corresponds to a first length L1 and a second length L2, and the minor axis of the ellipse corresponds to a first width W1 and a second width W2. The bottle retainer 16 is connected to the body 12 by a first arm 46 and a second arm 48 positioned at opposite ends of the bottle retainer 16, but other suitable arrangements may also be used. The bottle fixing member 16 is axially spaced from the main body 12, but other suitable arrangements can also be used.

[0020] In one aspect or embodiment, a method of utilizing Figures 1 to 7 The method of the bottle adapter 10 shown includes: squeezing the bottle retaining member 16 of the bottle adapter 10 to move the bottle retaining member 16 from a first position to a second position; while holding the bottle retaining member 16 to hold the bottle retaining member 16 in the second position, pushing the bottle adapter 10 onto the bottle 18 such that the piercing member 14 is positioned inside the bottle 18 and the body 12 of the bottle adapter 10 engages the bottle 18; and releasing the bottle retaining member 16 such that the bottle retaining member 16 returns to the first position, wherein the bottle retaining member 16 is positioned below the closure 20 of the bottle 18 to secure the bottle adapter 10 to the bottle 18.

[0021] refer to Figure 5 , Figure 8 and Figure 9 In some aspects or embodiments, the bottle adapter further includes a locking member 60 configured to lock the bottle retaining member 16 in a second position. In some aspects or embodiments, after the bottle adapter 10 is connected to the bottle 18, the locking member 60 is used to move the bottle retaining member 16 to a third position (e.g., Figure 8 As shown), in the third position, the bottle fixing member 16 has a third length L3 and a third width W3. The third width W3 is less than the second width W2, and the third length L3 is greater than the second length L2. Figure 5 and Figure 9As shown, the bottle retaining member 16 may define a first opening 62 and a second opening 64, wherein a locking member 60 extends through the first opening 62 and the second opening 64 of the bottle retaining member 16. In one aspect or embodiment, the locking member 60 is a cable tie, but other suitable fasteners or arrangements may be utilized. The locking member 60 is configured to further secure the bottle retaining member 16 and, once the locking member 60 is secured, for example by pulling one end of the locking member 60, prevents any loosening or opening of the bottle retaining member 16.

[0022] refer to Figures 10 to 12 In another aspect or embodiment, besides the bottle adapter 10 including a cycloidal-shaped bottle fixing member 68 defining a curved side 70, the bottle adapter 10 and Figures 1 to 7 The same as shown and described above. The curved side 70 of the bottle retaining member 68 is configured to expand radially to receive a first bottle 72 having a first diameter and a second bottle 74 having a second diameter, wherein the second diameter is larger than the first diameter. The bottle retaining member 68 can also receive and secure a third bottle 76 having a third diameter to the bottle adapter 10, wherein the third diameter is smaller than the first diameter. In other words, the cycloidal shape of the bottle retaining member 68 is configured to allow the bottle retaining member 68 to be biased or deflected from a closed position to an open position to accommodate different bottle sizes, and then return to an unbiased position in which the bottle retaining member 68 is positioned below the closure 20 of the bottle 18 to secure the bottle adapter 10 to the bottle 18.

[0023] While this disclosure has been described as having an exemplary design, it can be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover such deviations from this disclosure within practices known or customary in the art to which this disclosure pertains, and such deviations fall within the limitations of the appended claims. To the extent possible, one or more features of any aspect or embodiment described above may be combined with one or more features of any other aspect or embodiment.

Claims

1. A bottle adapter, comprising: The main body has a component connection interface, which is configured as a connection interface for engaging mating components. A piercing member having a first end and a second end, the first end being connected to the body and the second end being positioned opposite the first end, the piercing member and the body defining a fluid channel in fluid communication with the component connection interface; as well as A bottle fixing member extends from the body and is configured to fix the body to a bottle. The bottle fixing member is movable between a first position and a second position. In the first position, the bottle fixing member defines a first length and a first width. In the second position, the bottle fixing member has a second length and a second width, wherein the first length is greater than the first width, the first length is greater than the second length, and the second width is greater than the first width.

2. The bottle adapter of claim 1, further comprising a pressure balancing assembly having a balancing housing and an expandable member defining a space configured to expand from a first volume to a second volume, the second volume being larger than the first volume, the balancing housing defining a balancing opening in fluid communication with the space, wherein, The piercing member defines a pressure balance channel in fluid communication with the balance opening.

3. The bottle adapter according to claim 1, wherein, The bottle fixing component is ring-shaped.

4. The bottle adapter according to claim 1, wherein, The bottle fixing component is flexible and configured to be reshaped by medical personnel to move between the first position and the second position.

5. The bottle adapter according to claim 1, wherein, The bottle-fixing member defines an ellipse, wherein the major axis of the ellipse corresponds to the first length and the second length, and the minor axis of the ellipse corresponds to the first width and the second width.

6. The bottle adapter according to claim 1, wherein, The bottle fixing component is connected to the main body via a first arm and a second arm.

7. The bottle adapter according to claim 1, wherein, The bottle fixing component is axially spaced from the main body.

8. The bottle adapter of claim 1, further comprising a locking member configured to lock the bottle fixing member in the second position.

9. The bottle adapter according to claim 8, wherein, The bottle-fixing member defines a first opening and a second opening, and the locking member extends through the first opening and the second opening of the bottle-fixing member.

10. The bottle adapter according to claim 9, wherein, The locking component includes cable ties.

11. The bottle adapter according to claim 1, wherein, The component connection interface includes a diaphragm and is configured to mate with a syringe adapter.

12. The bottle adapter according to claim 1, wherein, The main body and the balancing shell are formed separately.

13. A bottle adapter, comprising: The main body has a component connection interface, which is configured as a connection interface for engaging mating components. A piercing member having a first end and a second end, the first end being connected to the body and the second end being positioned opposite the first end, the piercing member and the body defining a fluid channel in fluid communication with the component connection interface; as well as A bottle fixing member extending from the body and configured to fix the body to a bottle, the bottle fixing member being cycloidal in shape and defining a curved side, the curved side of the bottle fixing member being configured to expand radially to receive a first bottle having a first diameter and a second bottle having a second diameter, wherein the second diameter is larger than the first diameter.

14. The bottle adapter of claim 13, further comprising a pressure balancing assembly having a balancing housing and an expandable member defining a space configured to expand from a first volume to a second volume greater than the first volume, the balancing housing defining a balancing opening in fluid communication with the space, wherein... The piercing member defines a pressure balance channel in fluid communication with the balance opening.

15. The bottle adapter according to claim 13, wherein, The bottle fixing component is flexible and configured to be reshaped by medical personnel to move between the first position and the second position.

16. The bottle adapter of claim 13, further comprising a locking member configured to lock the bottle fixing member in the second position.

17. The bottle adapter according to claim 16, wherein, The bottle-fixing member defines a first opening and a second opening, and the locking member passes through the first opening and the second opening of the bottle-fixing member.

18. The bottle adapter according to claim 16, wherein, The locking component includes cable ties.

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