Ball nozzle dispenser with hermetically sealed eccentric polymer ampoule

Abstract

Provided herein is a liquid adhesive dispenser device comprising a housing having: a first housing portion having a proximal end, a distal end, a first port at the distal end, and a sidewall between the proximal end and the distal end, the proximal end, the distal end, and the sidewall defining a first chamber, the first chamber is configured to hold a liquid adhesive; a second housing portion having a proximal end, a distal end, a second port at the distal end, and a sidewall between the proximal end and the distal end of the second housing portion, the proximal end, the distal end, and the sidewall of the second housing portion defining a second chamber configured to receive a liquid adhesive; and a ball applicator disposed adjacent to the second port, where the first housing portion has a distally extending projection disposed to seal the first port, where the second housing portion has a first seat disposed adjacent to a proximal end thereof and a second seat disposed adjacent to a proximal end thereof, where the second seat is disposed to seal the second port. A first seat is configured to receive a distally extending projection of the first housing portion, and a second seat adjacent a distal end thereof, the second seat being configured to rotatably retain a ball applicator.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present invention claims priority to U.S. patent application Ser. No. 18 / 094,878, filed on Jan. 9, 2023, entitled “Ball Nozzle Dispenser with Hermetically Sealed Eccentric Polymer Ampoules,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to fluid dispensing devices, and in particular to disposable and / or single-use liquid adhesive dispenser devices for dispensing a quantity of liquid adhesive for use in medical procedures such as intravenous (IV) port securement, insertion site sealing, and / or wound closure procedures. Background Art

[0004] Liquid adhesives, such as curable polymer solutions, are used in medical procedures, such as fixing intravenous (IV) ports to patient skin, and for wound closure and insertion site sealing to prevent or reduce microbial invasion. For example, minimally invasive surgery, such as laparoscopic surgery, typically uses small incisions to complete. Such small incisions can be closed by traditional techniques, such as introducing sutures or staples to close incisional wounds. However, recently, the use of surgical adhesives has gained favor in closing incisions and wounds.

[0005] Many different packaging configurations, dispenser devices and applicators have been developed to provide a predetermined amount of liquid adhesive to a specific surgical site, such as a wound or insertion site. For example, the liquid adhesive can be provided in a disposable bag or sleeve that can be punctured or torn to release the liquid adhesive contained therein. Disposable tools, such as swabs, brushes or sponges, can also be used to provide the liquid adhesive to the patient's skin. More complex dispensers and applicator devices may include sealed ampoules, cartridges, vials or other containers that hold a certain amount of liquid adhesive to provide to the wound or incision site. Many existing dispenser devices include a mechanism for opening the container and then allowing the liquid adhesive to be discharged from the container by gravity. Other dispenser devices may include a pumping or squeezing mechanism for discharging the liquid adhesive from the dispenser device.

[0006] However, there is a need for improved dispenser devices that allow the user to precisely control the fluid flow rate and volume to deposit a desired amount of liquid adhesive at a desired surgical / wound site. The dispenser device of the present disclosure is configured to provide such precise control over fluid release while also providing a long shelf life and preventing contamination and leakage of the device and / or the liquid adhesive contained therein prior to use. Summary of the Invention

[0007] The present invention provides a liquid adhesive dispenser device, comprising a housing having a first housing portion, the first housing portion having a proximal end, a distal end, a first port at the distal end, and a sidewall between the proximal and distal ends, the proximal end, distal end, and sidewall defining a first chamber configured to hold a liquid adhesive; a second housing portion having a proximal end, a distal end, a second port at the distal end, and a sidewall between the proximal and distal ends of the second housing portion, the proximal end, distal end, and sidewall of the second housing portion defining a second chamber configured to receive the liquid adhesive; and a roller ball applicator arranged adjacent to the second port, wherein the first housing portion has a distally extending protrusion, the distally extending protrusion being arranged to seal the first port, wherein the second housing portion has a first seat and a second seat, the first seat being arranged adjacent to its proximal end and configured to receive the distally extending protrusion of the first housing portion, and the second seat being adjacent to its distal end and configured to rotatably hold the roller ball applicator.

[0008] According to an embodiment of the invention, the first port and the protrusion are radially offset with respect to a center of the distal end of the first housing part.

[0009] According to one embodiment of the invention, the first seat is radially offset with respect to the centre of the proximal end of the second housing part.

[0010] According to an embodiment of the present invention, the first housing part is rotatable relative to the second housing part.

[0011] According to an embodiment of the present invention, the protrusion is retained within the first seat and is frangible such that as the first housing portion and / or the second housing portion are rotated relative to each other, the protrusion is removed from the first port, thereby placing the first chamber in fluid communication with the second chamber.

[0012] According to one embodiment of the present invention, the roller ball applicator is configured to rotate as the device is moved over the patient's skin, thereby allowing the liquid adhesive to be delivered to the patient's skin.

[0013] According to an embodiment of the invention, the second port and the roll-on applicator are arranged such that one or more fluid paths exist between the roll-on applicator and a side wall of the second housing portion.

[0014] According to an embodiment of the invention, the second port and the roll-on applicator are arranged such that one or more slots are present between the roll-on applicator and a side wall of the second housing portion.

[0015] According to one embodiment of the invention, the second housing part is collapsible.

[0016] According to an embodiment of the invention, the second housing part comprises one or more gripping portions arranged on an outer surface of the side wall.

[0017] According to an embodiment of the present invention, the liquid adhesive dispenser device further comprises liquid adhesive received in the first chamber.

[0018] According to one embodiment of the present invention, the amount of liquid adhesive received in the first chamber is a single-use amount.

[0019] According to one embodiment of the present invention, the single dosage is equal to or less than about 1.0 mL, optionally less than about 0.5 mL, optionally less than about 0.2 mL.

[0020] According to an embodiment of the present invention, the liquid adhesive comprises a tissue adhesive configured for securing a vascular access device to a patient's skin, a wound closure, and / or an insertion site closure.

[0021] According to one embodiment of the present invention, the liquid adhesive comprises a cyanoacrylate composition.

[0022] According to one embodiment of the invention, the first housing portion comprises a flange at a distal end thereof, the flange being configured to be received within a recess adjacent to a proximal end of the second housing portion.

[0023] Also provided herein is a kit comprising a liquid adhesive dispenser device and packaging configured to hold the liquid adhesive dispenser device.

[0024] According to one embodiment of the invention, the device is hermetically sealed within the packaging.

[0025] According to one embodiment of the invention, the device and / or packaging is sterilized. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a side view of an apparatus according to a non-limiting embodiment described herein;

[0027] Figure 2A is a cross-sectional view of a device according to a non-limiting embodiment described herein;

[0028] Figure 2B is a cross-sectional view of a device according to a non-limiting embodiment described herein;

[0029] Figure 3A is a partial cross-sectional view of an apparatus according to a non-limiting embodiment described herein;

[0030] Figure 3B is a partial cross-sectional view of an apparatus according to a non-limiting embodiment described herein;

[0031] Figure 4 is a side view of an apparatus according to a non-limiting embodiment described herein;

[0032] Figure 5 is a perspective view of a device and packaging thereof according to a non-limiting embodiment described herein; and

[0033] Figure 6 is a schematic diagram of a process for forming an apparatus according to non-limiting embodiments described herein. DETAILED DESCRIPTION

[0034] The following description is provided to enable those skilled in the art to make and use the described embodiments, which are contemplated for use in practicing the present invention. However, various modifications, equivalents, variations, and alternatives will remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0035] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the present invention as it is oriented in the accompanying drawings. However, it is to be understood that the present invention may assume various alternative variations, unless expressly specified to the contrary. It is also to be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0036] It should be understood that any numerical range recited herein is intended to include all values and subranges contained therein. For example, the range "1 to 10" is intended to include all subranges between the listed minimum value of 1 and the listed maximum value of 10 (inclusive of 1 and 10), that is, having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10.

[0037] Provided herein is a dispensing device, optionally for liquid adhesives, that can be used to provide controlled application of a fluid, such as a liquid adhesive, to a skin puncture site, such as a venipuncture via a central venous catheter (CVC), a peripheral intravenous catheter (PIVC), or a peripherally inserted central catheter (PICC).

[0038] Go to Figure 1 , shows a non-limiting embodiment of a dispensing device 100, comprising a first housing portion 110 and a second housing portion 120. The first housing portion 110 can be an ampoule and can include a proximal end 112, a distal end 114 and a sidewall 116 therebetween, the proximal end, the distal end and the sidewall defining a first chamber 118, the first chamber being configured to receive and / or retain a liquid adhesive. The first housing portion 110 can be formed from any suitable material, such as a plastic material. In a non-limiting embodiment, the first housing portion 110 is collapsible such that a user can compress the sidewall 116 to discharge the liquid adhesive received or retained therein. The first housing portion 110 can also include a first port 117 disposed at its distal end 114, the first port being sealed by a protrusion 115. The protrusion 115 can be frangible and can take any suitable shape. As Figures 2A to 2B , the protrusion 115 can be generally circular and can include a frustoconical portion. The port 117 can be eccentrically disposed at the distal end 114 of the first housing portion 110. For example, the port 117 can be radially offset relative to the center of the first housing portion 110, such as relative to a longitudinal axis extending through the center of the first housing portion 110 in the proximal-distal direction.

[0039] The second housing portion 120 may be a nozzle and may include a proximal end 122, a distal end 124, and a sidewall 126 therebetween, the proximal end, the distal end, and the sidewall defining a second chamber 128 configured to receive and / or retain a liquid adhesive. The second housing portion 120 may be formed from any suitable material, such as a plastic material. In a non-limiting embodiment, the second housing portion 120 is collapsible so that a user can compress the sidewall 126 to expel the liquid adhesive received or retained therein. In a non-limiting embodiment, the sidewall 126 includes one or more grips 142 configured to allow a user to grip the sidewall 126 to compress the second housing portion 120. The second housing portion 120 may also include a second port 127 disposed at its distal end 124. The second port 127 may include a rollerball applicator 140 received within the port 127.

[0040] Go to Figures 2A to 2B , showing the state before its use ( Figure 2A ) and use ( Figure 2B) configuration. As shown in these cross-sectional views, the roller ball applicator 140 of the second housing portion 120 can be optionally rotatably secured within the second port 127 by a first seat 134. The first seat 134 can be formed by a flange having a passage 136 therethrough to allow the liquid adhesive to pass through the second chamber 128 and out of the second port 127. The second housing portion 120 can also include a second seat 132, which is optionally connected to the sidewall 126 of the second housing portion by the flange 130. The second seat 132 can be eccentrically disposed at the proximal end 122 of the second housing portion 120. For example, the second seat can be radially offset relative to the center of the second housing portion 120, such as radially offset relative to a longitudinal axis extending through the center of the second housing portion 120 in the proximal-distal direction.

[0041] like Figures 2A to 2B , the first housing portion 110 can include a flange 119 at its distal end 114 that is configured to be received within a corresponding recess 123 in a sidewall 126 of the second housing portion 120 at its proximal end 122. This arrangement can allow for a snap fit between the first housing portion 110 and the second housing portion 120 while optionally maintaining a rotatable relationship between the first housing portion 110 and the second housing portion 120. That is, the first housing portion 110 and the second housing portion 120 can be fixed to each other and can rotate relative to each other.

[0042] like Figure 2A As shown in FIG, in the pre-use configuration, a protrusion 115 blocking a first port (not shown) of the first housing portion 110 may be received within a seat 132 in the second housing portion 120. Figure 2B As noted above, the first housing portion 110 and the second housing portion 120 can rotate relative to each other. Due to the eccentric arrangement of the first port 117 (and protrusion 115) and the second seat 132, rotation of the housing portions 110, 120 relative to each other can cause the protrusion 115 to disengage from the port 117. This disengagement places the first chamber 118 in fluid communication with the second chamber 128, thereby allowing any liquid adhesive received and / or retained within the first chamber 118 to flow to the second chamber 128 (at Figure 2B depicted by arrows).

[0043] With the first chamber 118 and the second chamber 128 placed in fluid communication and the liquid adhesive entering the second chamber 128, such adhesive can be dispensed through the second port 127 in a variety of ways. The liquid adhesive can be actively dispensed from the device 100 by a user applying pressure to and compressing the first housing portion 110 and / or the second housing portion 120. As used herein, "active" dispensing of the liquid adhesive means that some portion or component of the device 100 is manipulated or actuated to force the liquid adhesive out of the device 100. In contrast, "passive" dispensing of the liquid adhesive refers to the movement of the fluid caused by environmental or inherent forces, such as gravity, the natural elasticity of a container or component of the device, osmosis, pressure differentials, etc.

[0044] Go to Figures 3A to 4 , various arrangements of the second port 127 and the roller ball applicator 140 are shown, optionally for passive and / or active dispensing of the liquid adhesive. Figure 3A In a non-limiting embodiment, an arrangement is shown in which a roller ball applicator 140, a first seat 134, and a distal end 124 of the second housing portion 120 are arranged, wherein one or more fluid flow channels 150 are arranged around the circumference of the roller ball applicator 140 and between the roller ball applicator 140 and the distal end 124 of the second housing portion 120. The liquid adhesive can flow around the roller ball applicator 140, for example, by gravity and / or capillary effect, and can be applied to the area of interest on the patient's skin by rolling the roller ball applicator 140 over the area. In a non-limiting embodiment, the distal end 124 of the second housing portion 120 can include one or more slots 152 therein, such as, for example, Figures 3B to 4 . The size and arrangement of the slots 152 can enable the liquid adhesive to be dispensed in the form of droplets through the slots 152, for example, by active dispensing as described above. In such an embodiment, applying pressure to the second housing portion 120 can force the rollerball applicator 140 to move distally, sealing the one or more flow channels 150 and forcing the liquid adhesive through the one or more slots 152 (optionally in the form of droplets).

[0045] refer to Figure 5Also provided herein is a kit 200 comprising a liquid adhesive dispensing device 215 as described herein, and packaging 260 in which the device 215 can be received. As previously described, the device 215 can include: a first housing portion 210, optionally in the form of an ampoule; a second housing portion 220, optionally in the form of a nozzle; a roll-on applicator 240 disposed at a distal end of the second housing portion 220; and optionally, one or more grips 242 disposed on the second housing portion 220. The first housing portion 210 and the second housing portion 220 can include any of the features described herein. In a non-limiting embodiment, the device 215 is hermetically sealed within the packaging 260. In a non-limiting embodiment, the packaging 260 is tearable, for example, at a perforation, to allow a user to remove the device 215 from the packaging 260. In a non-limiting embodiment, when the device 215 is packaged, the device 215 and / or the package 260 are sterilized such that the device 215 remains sterile within the package 260 during commerce, optionally until the device 215 is removed.

[0046] Continuing with reference to the accompanying drawings and further referring to the above-described non-limiting embodiments, in non-limiting embodiments, the liquid adhesive is a tissue adhesive, also known as surgical glue, skin glue, or liquid suture, configured to adhere to the patient's skin. Tissue adhesives can be used, for example, to secure vascular access devices (such as intravenous (IV) ports) to the patient's skin. Tissue adhesives can also be used for wound closure or insertion site sealing to prevent microbial invasion. As is known in the art, the dispensing devices 100, 215 disclosed herein can be filled with various different types of biocompatible tissue adhesives. For example, the tissue adhesive contained in the dispensing devices 100, 215 can be a cyanoacrylate composition.

[0047] In some non-limiting embodiments, the dispensing devices 100, 215 disclosed herein can be configured as single-use and / or disposable devices that are configured to be discarded after delivering a single dose or single-use amount of liquid adhesive. As used herein, a "single-use amount" of a liquid adhesive refers to the amount of adhesive required to perform common medical actions, including but not limited to IV port fixation, wound closure of small wounds or incisions, and / or insertion site sealing. For example, the dispensing devices 100, 215 can be configured to accommodate less than about 1.0 mL, preferably less than 0.5 mL, or more preferably less than about 0.2 mL of liquid adhesive. In other examples, the dispensing devices 100, 215 can accommodate from about 0.05 mL to about 1.0 mL of liquid adhesive.

[0048] refer to Figure 6, this article also provides a process 300 for manufacturing a liquid adhesive dispensing device as described herein. Process 300 may include the step of extruding 310 a material (e.g., a polymeric material) into a mold. As described above, any suitable material may be used, such as a material with resilience, flexibility, and / or elasticity, to allow the device to be compressed to actively dispense liquid adhesive when needed. The step of forming 320 one or more parts of the liquid adhesive dispensing device within the mold may then be performed. In a non-limiting embodiment, a first housing portion (e.g., an ampoule) is formed in the mold in steps 310 and 320, and then filled 330 with liquid adhesive. In such an embodiment, the further step of sealing 340 the device (e.g., an ampoule) may then be performed. Thereafter, the device (e.g., an ampoule) may be sealed 340 and demoulded 350.

[0049] Although the present disclosure has been described in detail for illustrative purposes based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is intended for that purpose only and that the present disclosure is not limited to the disclosed embodiments or aspects, but 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 can be combined with one or more features of any other embodiment.

Claims

1. A liquid adhesive dispenser device comprising: A housing, the housing comprising: a first housing portion comprising a proximal end, a distal end, a first port at the distal end, and a sidewall therebetween, the proximal end, the distal end, and the sidewall defining a first chamber configured to hold a liquid adhesive; a second housing portion comprising a proximal end, a distal end, a second port at the distal end, and a sidewall between the proximal and distal ends of the second housing portion, the proximal end, the distal end, and the sidewall of the second housing portion defining a second chamber configured to receive a liquid adhesive; as well as a roller ball applicator disposed adjacent the second port, wherein the first housing portion comprises a distally extending protrusion, the distally extending protrusion being arranged to seal the first port, wherein the second housing portion includes a first seat disposed adjacent a proximal end thereof and configured to receive a distally extending protrusion of the first housing portion, and wherein the second housing portion includes a second seat adjacent a distal end thereof and configured to rotatably retain the roller ball applicator.

2. The device according to claim 1, wherein The first port and the distally extending protrusion are radially offset from a center of the distal end of the first housing portion.

3. The device according to claim 2, wherein The first seat is radially offset relative to a center of the proximal end of the second housing portion.

4. The device according to claim 3, wherein The first housing portion is rotatable relative to the second housing portion.

5. The device according to claim 4, wherein The distally extending protrusion is retained within the first seat and is frangible such that as the first housing portion and / or the second housing portion are rotated relative to each other, the distally extending protrusion is removed from the first port, thereby placing the first chamber in fluid communication with the second chamber.

6. The device according to claim 5, wherein The roll-on applicator is configured to rotate as the device is moved across the patient's skin, thereby allowing liquid adhesive to be delivered to the patient's skin.

7. The device according to claim 1, wherein The second port and the roll-on applicator are arranged such that one or more fluid paths exist between the roll-on applicator and a sidewall of the second housing portion.

8. The device according to claim 1, wherein The second port and the roll-on applicator are arranged such that one or more slots are present between the roll-on applicator and a sidewall of the second housing portion.

9. The device according to claim 1, wherein The second housing portion is collapsible.

10. The device according to claim 1, wherein The second housing portion includes one or more grips disposed on an outer surface of the side wall.

11. The device of claim 1 , further comprising a liquid adhesive received within the first chamber.

12. The device of claim 11, wherein the amount of liquid adhesive received in the first chamber is a single-use amount.

13. The device of claim 12, wherein the single-use volume is equal to or less than about 1.0 mL, optionally less than about 0.5 mL, optionally less than about 0.2 mL.

14. The device of claim 1, wherein the liquid adhesive comprises a tissue adhesive configured to secure a vascular access device to a patient's skin, a wound closure, and / or an insertion site closure.

15. The device of claim 1, wherein the liquid adhesive comprises a cyanoacrylate composition.

16. The device according to claim 1, wherein The first housing portion includes a flange at a distal end thereof that is configured to be received within a recess adjacent a proximal end of the second housing portion.

17. A kit comprising: A liquid adhesive dispenser device comprising: A housing, the housing comprising: a first housing portion comprising a proximal end, a distal end, a first port at the distal end, and a sidewall therebetween, the proximal end, the distal end, and the sidewall defining a first chamber configured to hold a liquid adhesive; a second housing portion comprising a proximal end, a distal end, a second port at the distal end of the second housing portion, and a sidewall between the proximal and distal ends of the second housing portion, the proximal end, the distal end, and the sidewall of the second housing portion defining a second chamber configured to receive a liquid adhesive; and a roller ball applicator disposed adjacent the second port, wherein the first housing portion comprises a distally extending protrusion, the distally extending protrusion being arranged to seal the first port, wherein the second housing portion includes a first seat disposed adjacent a proximal end thereof and configured to receive a distally extending protrusion of the first housing portion, and wherein the second housing portion includes a second seat adjacent a distal end thereof and configured to rotatably retain the roll-on applicator; and A package is configured to receive the liquid adhesive dispenser device therein.

18. The kit of claim 17, wherein the liquid adhesive dispenser device is hermetically sealed within the packaging.

19. The kit of claim 17, wherein the liquid adhesive dispenser device and / or the packaging is sterilized.

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