• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    systems and methods for providing an antiseptic applicator. an antiseptic applicator device having a reservoir for storing an antiseptic agent, the reservoir being coupled to an applicator element, and a breakable membrane being interposed between the reservoir and the applicator element. embodiments of the device further include opposing wings, wherein an inner wing lumen houses a breakable vial containing a desired solution, and wherein from moving the wings to a closed position, the vials are broken to release the solutions. which are then absorbed by the applicator element.
    公开号:BR112012005863B1
    申请号:R112012005863
    申请日:2010-08-04
    公开日:2019-12-03
    发明作者:Karl Burkholz Jonathan；Hoang Minh；f harding Weston
    申请人:Becton Dickinson Co；
    IPC主号:
    专利说明:

    "APPLICATOR DEVICE AND METHOD FOR MAKING THE SAME" BACKGROUND OF THE INVENTION The present invention relates to systems and methods for providing an antiseptic applicator. The antiseptic applicator is used to apply an antiseptic agent to a desired surface thereby preparing the surface for an antiseptic procedure or treatment.
    Antiseptic and antibacterial agents are commonly used to treat various wounds, such as cuts and abrasions. These agents are also commonly applied to various surfaces in preparation for sterile or antiseptic procedures. For example, a common preoperative procedure in the medical industry involves rubbing alcohol, iodine or peroxide on the surface of a skin to exterminate bacteria and thereby reduce the chance of infection. Other common practices include cleaning a chair or table surface with an antiseptic agent before exposing a patient or instruments to the surface.
    Typically, an applicator, such as a cotton swab or foam element, is soaked with an antiseptic that must be poured from a bottle or other container. This step requires the user to remove the container lid and foil seal to access the antiseptic. In an emergency situation, or in a situation where one of the user's hands is occupied, the user must release both hands to access the antiseptic agent. In addition, when the bottle or other container is opened, the sterility of the bottle is normally compromised resulting in excess waste of otherwise useful antiseptic agent.
    After these steps, the antiseptic is usually poured into an open secondary container that provides a puddle in which the applicator is dipped or soaked. The open, secondary container can include a plate or a small bowl having a large opening through which the applicator is passed. In an emergency situation the user must be careful to prevent reaching or disarming the secondary container in order to prevent spillage of the antiseptic. In the event that the antiseptic agent is spilled, additional antiseptic should be provided thereby requiring the user to once again access the antiseptic container or bottle.
    In other procedures, an antiseptic agent is applied directly to a surface from the bottle or other container, and is then spread and applied with the applicator. During these procedures, the user must take care to control the amount of antiseptic used to contain the antiseptic and avoid wasting substances.
    For some procedures, a portion of the applicator that contacts the desired surface is held directly in the user's hand. For example, where the applicator is a cloth and the surface is a table top, the user usually holds the cloth in his hands and rubs the surface with the cloth. The proximity of the user's hand to the table surface poses the risk of contaminating the recently cleaned surface with the user's hand. Although the user may choose to wear protective gloves or wash their hands before applying the antiseptic, in an emergency situation the user may not have enough time to take the necessary care.
    Thus, although there are currently techniques that are used to apply an antiseptic agent to a desired surface, challenges remain. Consequently, it would be an improvement in the technique to increase or even replace current techniques with other techniques.
    BRIEF SUMMARY OF THE INVENTION The present invention relates to a convenient hand-held device for delivering an antiseptic solution to a desired surface. Some embodiments of the present invention provide an applicator device including a body having a lumen for receiving an antiseptic agent. The body is usually composed of a semi-flexible polymer material capable of being compressed or squeezed by a user. One end of the body is configured to receive a fluid reservoir containing a desired antiseptic solution. When coupling the fluid reservoir to the body, the solution inside the reservoir is transferred to the body lumen. At the other end of the body, the device includes an adapter element to absorb and apply the antiseptic solution to a desired surface. The applicator element generally includes a foam or non-woven material suitable for applying the antiseptic solution.
    A destructible membrane is interposed between the body lumen and the applicator, in such a way that the antiseptic agent is prevented from contacting the applicator. In some embodiments, the device also includes a wing so that after activation of the wing the membrane is destroyed in this way allowing the antiseptic agent to flow through the membrane and contact the applicator. In other embodiments, the membrane is destroyed simply by compressing the body of the device to increase the pressure within the lumen. The increased pressure is released when the membrane is destroyed and the antiseptic agent can flow through the membrane. In other embodiments, the membrane is replaced by a one-way valve that is destroyed by increasing the pressure within the body's lumen.
    In some embodiments of the present invention, the applicator is shaped and configured to apply the antiseptic agent to an orifice, such as a boa or a breather tube. In other embodiments, the applicator is shaped and configured to apply the antiseptic agent to a generally flat surface such as an I.V. insertion site, a surgical procedure site or a table.
    For some implementations of the present invention, the antiseptic applicator device includes a pair of opposite wings coupled to an applicator element. Each wing includes an inner lumen configured to accommodate a fluid reservoir, such as an ampoule or vial. Each lumen is in fluid communication with the applicator element, such that when a fluid reservoir is destroyed, the fluid contained in the reservoir is released and absorbed by the applicator element.
    In some embodiments, the fluid reservoir for each wing is destroyed simply by compressing or squeezing the outer surface of the wing to crush or rupture the reservoir material. In other embodiments, a wedge tip is positioned between the opposing wings in such a way that the wings are moved to a closed position, the wedge tip is driven into or against the fluid reservoirs thereby destroying the reservoirs.
    When a fluid reservoir is included in each of the two wings, the fluid reservoir for each wing can include the same or different solutions. For example, where the antiseptic agent is a two-part reagent, the fluid reservoir on one wing can include the first part of the antiseptic agent, and the fluid reservoir on the other wing can include the second part of the antiseptic agent. Thus, when the reservoirs are destroyed, the first and second half of the antiseptic agent are mixed to provide the desired antiseptic solution.
    In some embodiments, it may be desirable to apply a first solution contained in the fluid reservoir of the first wing before applying a second solution contained in the fluid reservoir of the second wing. Thus, some embodiments of the device include a multi-stage wedge tip whereby the first fluid reservoir is destroyed based on a first position of the opposite wings, and the second fluid reservoir is destroyed based on a second position of the opposite wings . In addition, some embodiments include a layered applicator such that contaminated layers of the element can be removed to provide a new, uncontaminated application surface.
    Finally, in some embodiments, the device includes a membrane that has a grooved surface that is partially destroyed in response to lateral force. When the lateral force is increased, additional portions of the membrane are destroyed in this way allowing more flow of the antiseptic agent through the membrane. In other embodiments, the membrane includes a plurality of grooves having various thicknesses and dimensions to progressively destroy for the membrane in response to progressive increases in lateral force against the membrane.
    BRIEF DESCRIPTION OF THE VARIOUS VIEWS OF THE DRAWINGS
    In order to readily understand the manner in which the characteristics and advantages mentioned above and other characteristics of the invention are obtained, a more specific description of the invention briefly described above will be presented with reference to its specific modalities which are illustrated in the accompanying drawings. These drawings illustrate typical embodiments of the invention and, therefore, should not be considered to limit the scope of the invention. Figure 1 is a perspective view of an antiseptic applicator device according to a representative embodiment of the present invention. Figure 2A is a cross-sectional view of an antiseptic applicator device before activation in accordance with a representative embodiment of the present invention. Figure 2B is a cross-sectional view of an antiseptic applicator device after activation in accordance with a representative embodiment of the present invention. Figure 3A is a cross-sectional view of an antiseptic applicator device before activation when coupled to a fluid reservoir according to a representative embodiment of the present invention. Figure 3B is a cross-sectional view of an antiseptic applicator device before activation when coupled to a fluid reservoir according to a representative embodiment of the present invention. Figure 4 is a cross-sectional view of an antiseptic applicator device including a one-way valve according to a representative embodiment of the present invention. Figure 5A is a perspective view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 5B is a top view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 5C is a rear cross-sectional view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 5D is a rear cross-sectional view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 6A is a top view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 6B is a top view of a two-wing antiseptic applicator according to a representative embodiment of the present invention. Figure 7A is a top view of a two-wing antiseptic applicator device having a multi-stage wedge tip according to a representative embodiment of the present invention. Figure 7B is a top view of a two-wing antiseptic applicator device having a multi-stage wedge tip after breaking the first bottle according to a representative embodiment of the present invention. Figure 7C is a top view of a two-wing antiseptic applicator device having a multi-stage wedge tip after breaking the second bottle according to a representative embodiment of the present invention. Figure 8 is a perspective view of a two-wing antiseptic applicator having an elongated joint portion and angled wings in accordance with a representative embodiment of the present invention. Figure 9A is a cross-sectional view of an antiseptic applicator device incorporating a grooved membrane according to a representative embodiment of the present invention. Figure 9B is a cross-sectional view of Figure 9A showing a grooved membrane according to a representative embodiment of the present invention.
    DETAILED DESCRIPTION OF THE INVENTION
    The currently preferred embodiments of the present invention will be better understood by reference to the drawings, where similar reference numbers indicate functionally similar or identical members. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is simply representative of the currently preferred embodiments of the invention.
    Referring now to Figure 1, an implementation of an antiseptic device 100 is shown. Some embodiments of antiseptic device 100 generally include a body 110, having a proximal end 112 and a distal end 114. Proximal end 112 is generally configured to receive from a reservoir 120 or vial containing an antiseptic agent 122, shown in spectrum, compatible form. In some embodiments, reservoir 120 contains approximately 0.5 - 50 ml of antiseptic agent 122. In other embodiments, reservoir 120 contains an alcohol-based antimicrobial solution.
    For example, in some embodiments, an antimicrobial solution according to the present invention includes a 50-95% alcohol solution that further includes additional antimicrobial agents such as CHG, PCMX, triclosan, octenidine, hexachlorophene, PVP-1, iodine, and / or quaterine compounds in the range of 0.05% to 5% by weight / weight. Alcohol is generally selected from at least one of ethyl alcohol, isopropyl alcohol, ol-n-propanol, and mixtures thereof. In some embodiments, the solution also contains dimethyl-na, glycerin, cationic polymer such as PVP, cellulose, docosanol, BTMS, beenyl alcohol and / or poloxamers. In a preferred embodiment, a basic antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin preparation, and 0.12% CHG in alcohol for mouth disinfection. Those of skill in the art will consider that other ingredients, including those mentioned above, can be added to each of the base antimicrobial solutions to provide a desired antimicrobial or antiseptic agent 122 for a specific application.
    In some embodiments, the reservoir 120 includes a neck portion 124 that has a set of threads 126 for screwing in with the compatible threads 200 (not shown) located within the proximal end 112 of the body 110. In other embodiments, the reservoir 120 is coupled to the proximal end 112 of the body 110 by means of a pressure adjustment, a mechanical interface, or an adhesive. Reservoir 120 further includes a membrane 128 or seal for retaining agent 122 within reservoir 120 prior to coupling reservoir 120 to body 110. Diaphragm 128 generally comprises a foil seal which is applied to opening 130 by means of an adhesive or heat sealing process. In some embodiments, membrane 128 comprises a cardboard or paper material coated with plastic that is applied to opening 130 in a similar manner. The membrane 128 may also include a polymer material. Finally, in some embodiments portions of the membrane are grooved 132 or otherwise weakened in this way causing the membrane 128 to break or be destroyed in a predictable manner.
    In some embodiments, the proximal end 112 of the body 110 further comprises a feature (not shown) whereby membrane 128 is perforated or otherwise destroyed from the coupling of reservoir 120 to body 110. For example, in some embodiments the proximal end 112 includes a tip 202 (see Figure 2A), so that by screwing the reservoir 120 into the proximal end 112, the tip 202 punctures and displaces the membrane 128 to provide access to the antiseptic agent 122 within the reservoir 120. Alternatively, in other embodiments, membrane 128 is physically removed from reservoir 120 before coupling reservoir 120 to body 110. The distal end 114 of body 110 includes applicator 140. Applicator 140 comprises a non-woven material or a sponge element foam that is attached to the distal end 114 by means of an adhesive that is compatible with the antiseptic agent 122. The size and shape of applicator 140 varies depending on the intended application of the antiseptic device 100. For example, the applicator 140 of the antiseptic device 100 is sized and formed for use as a mouth disinfectant device or a surgical / skin disinfectant device.
    Occasionally, the internal and / or external surfaces of the mouth must be disinfected, for example, before inserting a respirator tube or other medical device into the mouth or throat. Consequently, the shape and size of applicator 140 are designed for insertion compatible with a patient's mouth. For example, an applicator 140 for use as a mouth disinfectant device may include an elongated dome shape having a base diameter that is easily inserted into the patient's mouth. The elongated dome shape eliminates any right angles that might otherwise prevent complete and uniform contact between applicator 140 and the curved natural surfaces of the inner mouth. Additionally, in some embodiments, the outer surface of the applicator 140 includes a small radius that allows application of the applicator to the inner and outer surfaces of a respirator tube or other medical device before inserting the device into the patient's mouth.
    Where the antiseptic device 100 is intended as a surgical site / skin disinfectant device, applicator shape and size 140 is selected to provide a flat, wide surface to maximize contact between applicator 140 and a generally flat skin surface. An example of such an applicator is shown and discussed in connection with Figure 3B, below.
    In some embodiments, the antiseptic device 100 further comprises a wing 150. Wing 150 comprises a first end 152 coupled with the distal end 114 of the body 110 and a second end 154 which extends outwardly from the body 110. With Referring to Figure 2A, a cross-sectional view of antiseptic device 100 is shown. Body 110 of antiseptic device 100 comprises a hollow interior or lumen 212 for receiving and storing antiseptic agent 122 from reservoir 120. Body 110 further includes a fluid dispensing chamber 220. The fluid dispensing chamber 220 is located at the most distal end 114 of the body 110 and holds the applicator 140. In some embodiments, the fluid dispensing chamber 220 comprises a lumen 222 which has a plurality of windows 224 through which the antiseptic agent 122 flows and is absorbed by the applicator 140. In other embodiments, the lumen 122 of the chamber fluid dispenser 220 comprises a plurality of holes, slits or other orifices.
    In some embodiments, a breakable membrane 270 is interposed between the inner lumen 212 and the fluid dispensing chamber 220 of the body 110. The membrane 270 is provided to prevent fluid communication between the lumen 212 and the dispensing chamber fluid 220. A portion of membrane 270 is grooved 272 or otherwise weakened to encourage membrane 270 to break or shatter in a predictable manner. In some embodiments, the membrane 270 is located opposite the first end of the wing 150. Consequently, when the wing 150 is driven towards the body 110 from a closed position to an open position, the first end 152 of the handle 150 applies a torque force on the membrane 270 thus causing the membrane 270 to be smashed along the grooved portion 272, as shown in Figure 2B. When destroyed, an opening 280 is provided through the membrane 270 such that the lumen 212 and the fluid dispensing chamber 220 are in fluid communication.
    Referring now to Figure 3A, a cross-sectional view of the antiseptic device 100 is shown coupled to a reservoir in cross section, prior to the actuation of the wing 150. As previously discussed, when the antiseptic device 100 is coupled to the reservoir 120 the tip 202 perforates membrane 128 to provide fluid communication between reservoir 120 and internal lumen 212 of body 110. Thus, when membrane 128 is destroyed, antiseptic device 100 and fixed reservoir 120 are inverted to allow the antiseptic agent 122 flows into the inner lumen 212 of the body 110. However, before operating the wing 150 to a closed position, the antiseptic agent 122 is substantially prevented from bypassing the membrane 272 and flowing into the fluid dispensing chamber 220.
    With reference now to Figure 3B, a cross-sectional view of an antiseptic device 300 is shown attached to a reservoir in cross section, before the wing 150 is activated. In the process of coupling device 300 to reservoir 120, the tip feature 202 punctures, punctures, or otherwise destroys membrane 128 to provide fluid communication between reservoir 120 and inner lumen 212 of device body 110. Antiseptic device 300 is modified to include a linear flat applicator 340 that has a wide surface for apply antiseptic agent 122 to a generally flat surface. For this embodiment, the fluid dispensing chamber 320 generally comprises a tubular shape having an inclined end end surface 322 configured to receive the flat applicator 340. An opening 330 between the fluid dispensing chamber 320 and the applicator 340 allows the fluid within the dispensing chamber 320 contact applicator 340 and thereby be absorbed. Applicator 340 comprises a non-woven material or foam sponge element that is sized and textured for applying antiseptic agent 122 to a desired surface. For example, in some embodiments, applicator 340 includes an abrasive outer surface 342 to aid in exfoliation or debridement of a skin surface. In some embodiments, applicator 340 includes an abrasive outer surface to assist in rubbing and disinfecting an object, such as a piece of machinery or a surface such as a table or bed surface. And in some embodiments, applicator 340 includes a smooth outer surface for applying antiseptic agent 122 to disinfect a surface without severe scrubbing.
    In some embodiments, the end end surface 322 is inclined with respect to the body portion 110 of the antiseptic device 300. Consequently, when the applicator 340 is coupled to the end end surface 322, the applicator 340 is also inclined with respect to the body of applicator 110. Applicator angle 340 is selected to assist a user in contacting a surface with applicator 340 while holding the body portion 110 of the device in an ergonomically effective position. In addition, the position and length of the body portion 110 is selected to provide a grip surface for the device 300 and to remove the user's hand from the area near the applicator 340. As such, the wing function of the body portion 110 provides the user control over device 300 while preventing unwanted exposure and / or contamination of the treatment surface or location.
    Referring now to Figure 4, a cross-sectional view of an antiseptic device 400 is shown coupled to a reservoir in cross-section 120. In some embodiments, a one-way valve 410 is interposed with the fluid dispensing chamber 220 and internal lumen 212 of device 400. One-way valve 410 generally comprises a flexible or semi-flexible polymer material that is trapped within a constricted portion of inner lumen 212. In some embodiments, valve 410 includes a duckbill or like an umbrella. In other embodiments, valve 410 includes a slit 420 that is propelled to a closed position to prevent fluid communication between the fluid delivery chamber 220 and the inner lumen 212. However, when a pressure within the inner lumen 212 exceeds a limit pressure of the one-way valve 140, the one-way valve 410 is bypassed in such a way that the slot 420 opens to provide fluid communication between the inner lumen 212 and the fluid delivery chamber 220.
    For example, in some embodiments the body portion 110 of the device 400 comprises a semi-flexible tubing material capable of being compressed or tightened by the user. Thus, when the user compresses the body portion 110, the pressure inside the inner lumen 212 increases to exceed the limit pressure of the one-way valve 140. When this occurs, the one-way valve 410 is bypassed and the antis agent -septic 122 can bypass valve 410, through slot 420, and flow into the fluid delivery chamber 220. When the pressure is exhausted, the valve closes to prevent further flow into the dispensing chamber 220. In some modalities, the one-way valve 410 is replaced by a mechanical valve that the user directly manipulates, such as a sliding or flap valve. In other embodiments, the breakable membrane is replaced by a small hole that would allow the antiseptic agent 122 to flow from the inner lumen 212 to the dispensing chamber 220 when the body portion 110 is compressed. However, the fluid could not flow without compression due to the fact that the internal lumen is not ventilated and due to the surface tension of the antiseptic agent 122.
    Although applying positive pressure to the body portion 110 of the device 400 is a method of overriding valve 412, those of skill in the art will consider that other methods can be used to override valve 410 as well. For example, in some embodiments, the fluid dispensing chamber 220 is modified to include a vacuum source whereby the pressure within fluid dispensing chamber 220 is decreased below the limit pressure of one-way valve 410. In other embodiments, reservoir 120 comprises a syringe ( (not shown) containing an antiseptic agent 122. When the syringe is compressed, antiseptic agent 122 is injected into the inner lumen 212 thereby increasing the pressure within the inner lumen 212. When the pressure within the inner lumen 212 exceeds the valve's limit pressure one way 410, valve 410 is bypassed and antiseptic agent 122 flows into the fluid dispensing chamber 220 through the open slot 420.
    Referring now to Figure 5A-8, various embodiments of a two-winged antiseptic device are shown. Referring to Figure 5A, a perspective view of a two-wing device 500 is shown. The two-wing device 500 according to the present invention generally comprises a bifurcated body 510, wherein each half of the body forms an opposite wing. A joint portion 520 of the body 510 forms the terminal end 522 of the body 510, and is coupled to a mounting plate 530. The mounting plate 530 provides a generally flat surface to which an applicator 540 is attached. The bifurcated body 510 includes a first wing 512 and a second wing 514. The forked body 510 further includes an internal lumen 516 which is comprised of interconnected lumens located within the first wing 512, the second wing 514 and the joint portion 520. In some embodiments , a portion of the inner lumen 516 is configured to receive an ampoule or vial 550 containing a desired antiseptic agent 552. For example, in some embodiments portions of the lumen 516 located on each wing 512, 514 are configured to receive a vial 550 containing an agent antiseptic 552. Antiseptic agent 552 is released from each vial 550 when vial 550 is broken into the respective portion of lumen 516. In some embodiments, the bifurcated body 510 comprises a semi-flexible polymer material that is capable of being compressed or flexed by the user's hand. When the user compresses a single wing, for example, wing 512, vial 550 contained within wing 512 is broken in this way releasing antiseptic agent 552 from vial 550 and into the inner lumen 516. Alternatively, when the user holds and compresses the two wings together, vial 550 contained within each wing 512 and 514 is broken in this way releasing antiseptic agent 552 from each vial 550 and into the inner lumen 516. Thus, the material that can being broken from vial 550 serves as a barrier between antiseptic agent 552 and inner lumen 516.
    Referring now to Figure 5B, a top view of a two-winged device 500 is shown. In some embodiments, the bifurcated body 510 further includes a wedge tip 560 interposed with opposite wings 512 and 514. The wedge tip 560 generally comprises a rigid feature that has a tensile strength greater than the tensile strength of vial material 550. In some embodiments, the wedge tip 560 is positioned between the opposite wings in such a way that when the wings 512 and 514 are closed or placed together, the wedge tip 560 is clamped between the opposing wings resulting in the wedge tip 560 breaking the 550 bottles.
    Referring to Figure 5C, a rear cross-sectional view of the two-wing device 500 is shown. In some embodiments, the adjacent inner surfaces of the opposing wings 512 and 514 include access windows 524 through which a middle portion of the tip is positioned. wedge 560. The access windows 524 are generally configured to provide passage for the middle portion of the wedge tip 560 and still prevent the passage of fluid located within the lumen of each wing 512 and 514. The wedge tip 560 comprises a first end 562 located within the inner lumen of the first wing 512, and a second end 564 located within the inner lumen of the second wing 514. The first and second end 562 and 564 are connected via the middle portion of the wedge tip 560. In some embodiments, the first end 562 comprises a flat, anvil surface configured to lean directly against the flask 55 0 inside the first wing 512. The second end 564 comprises a concave surface configured to directly receive the outer diameter of the bottle 550 located in the second wing 514. Thus, when the first and second wings are closed or brought together, the wedge tip 560 binds each vial 550 against the inner surface of the outer wall of each wing. Continuous closing of the wings 512 and 514 then forces the first and second ends 562 and 564 of the wedge tip 560 through their respective vials 550 thereby releasing the antiseptic agents 552 contained therein.
    Referring now to Figure 5D, an alternative embodiment of the wedge tip 560 is shown. For this embodiment, the first end 582 and the second end 584 of the wedge tip 580 are configured to mate with the outer surfaces of the opposite wings 512 and 514 Consequently, when the first and second wings are closed or joined, the wedge tip 560 immobilizes the inner portions of the outer surface thereby causing vials 550 to be compressed and pressed between the inner surface of the outer wall of each wing. and the inner surface of the inner wall of each wing.
    Referring now to Figure 6A, an alternative wedge tip embodiment is shown. For this embodiment, the wedge tip 570 is a molded extension, woven connecting the first and second wings 512 and 514 adjacent to the joint portion 520 of the body 510. In some embodiments, the wedge tip 570 is formed during the molding process of the device body 510, wherein a mold used to form the body 510 includes an empty space to receive a sufficient amount of material to form the wedge tip 570. In other embodiments, the wedge tip 570 is formed or shaped into a separate process and subsequently coupled with the opposing wings 512 and 514 by means of an appropriate method, such as plastic welding, an adhesive, or interconnecting surfaces / resources.
    In some embodiments, the wedge tip 580 is provided having flap features 582 to apply force to a specific portion of the flasks 554. Some flasks 554 include a grooved surface 556 to promote or control how the flask 554 is broken. Consequently, in some embodiments, the wedge tip 580 includes flap features 582 which are designed to contact vials 554 so as to break vial 554 along the grooved surface 556. Flap features 582 may include a molded feature of the body of device 520, a separate device, or a combination of a molded feature and a separate device.
    In some embodiments, each vial 554 contained within the wing portion of the inner lumen 516 may contain the same or different solutions. For example, in some embodiments, bottle 554 of first bottle 512 contains a detergent solution, while bottle 554 of second wing 514 contains a disinfectant solution. A method for using different solutions may include: 1) Breaking a first bottle to release a first solution in which the first solution is a detergent to rinse and clean in and around an incision site to remove the bulk of the contamination before performing antiseptic preparation of the skin; and 2) Breaking a second bottle to release a second solution, where the second solution is an antiseptic agent suitable for skin preparation.
    Referring to Figures 7A-7C, a device 500 is shown housing a first vial 556 containing a first solution, and a second vial 558 containing a second solution. The device 500 also includes a multi-step wedge tip 590 positioned interposed with the first wing 512 and second wing 514. Finally, the device 500 includes a layered applicator including a first applicator 542 and a second applicator 540. The tip of multi-step wedge 590 comprises a first contact 592 coupled to a second contact 594 by means of a spacer 596. The first contact 592 is positioned adjacent to the joint portion 520 of the body so as to rest against only the first bottle 556. In some embodiments, the first and second vials 556 and 558 are positioned within the wings 512 and 514 such that the distal end 566 of the first vial 556 overlaps the distal end 568 of the second vial 558. The length of the spacer 596 is selected for provide a distance between the first contact 592 and the second contact 594 such that the first contact 592 is positioned adjacent the end distal 566 of the first vial 556, and the second contact 594 is positioned adjacent to the distal end 568 of the second vial 558. Thus, when moving the wings 512 and 514 to a partially closed position, as shown in Figure 7B, the first contact 592 from the multi-step wedge point 590 is driven into the distal end 566 of the first vial 556. When the first 556 is squeezed between the first contact 292 and the inner surface of the second wing 514, vial 556 is destroyed or broken 572 of that mode releasing the first solution.
    In some embodiments, the first solution comprises a detergent to remove the bulk of contaminants from a desired surface. Consequently, in some embodiments the device 500 includes a first applicator 542 which is sized and textured to rub or otherwise apply the detergent solution to the desired surface. After complete application of the first solution, the first applied 542 is removed from the device 500 to reveal the second uncontaminated applicator 540. The first applied 542, including the bulk of the contaminants contained therein, is then discarded.
    After removing the first applicator 542, the opposing wings 512 and 514 are moved to a completely closed position, as shown in Figure 7C. In that position, the second contact 594 of the multi-step wedge point is driven to the distal end 568 of the second vial 558. When the second vial 558 is squeezed between the second contact 594 and the inner surface of the first wing 512, the vial 558 it is destroyed or broken 574 thereby releasing the second solution.
    In some embodiments, the second solution comprises an antiseptic solution to clean or otherwise remove pathogens from a desired surface. Consequently, in some embodiments the second applicator 540 is sized and texturized to scrub or otherwise apply the antiseptic solution to a desired surface. After complete application of the second solution, device 500 is discarded.
    Referring now to Figure 8, an alternative embodiment of the two-loop device 800 is shown. In some embodiments, the body 810 of the two-loop device 800 further includes an elongated joint portion 820, wherein the wings 812 and 814 are coupled to the joint 820 portion at a desired angle. The elongated joint portion 820 increases the volume of the inner lumen 816 thereby accommodating an increased volume of antiseptic agent 852. Additionally, the increased volume allows for the placement of a sponge or filter 830 to prevent broken glass from entering the applicator 540.
    In some embodiments, the desired angle of the opposing wings 812 and 814 is selected to accommodate a user for optimal contact with a desired surface with the 540 applicator while holding the wings 812 and 814 in an ergonomically effective position. The combination of the slanted wings 812 and 814 and the elongated joint portion 820 further provides increased spacing between the user's hands and the applicator 540. This increased spacing is advantageous to prevent unwanted contamination of the applicator 540 and the treatment surface by the user's hands. . Consequently, in some embodiments it is convenient to optimize the length of the joint portion 820 and the angle of the wings 812 and 814 to provide a device 800 that is effective for sanitizing a desired surface and provides an ergonomic handle.
    In other embodiments, the size and length of the opposing wings 812 and 814 are configured to adapt the device 800 to a specific procedure or grip technique. For example, for some procedures a large volume of antiseptic agent is thus required requiring the size of the opposing wings 812 and 814 to be increased. In addition, where a user wants to hold the device 800 by squeezing the device between their fingers, the size of the opposing wings 812 and 814 is decreased to ensure adequate control of the device through the desired grip. In some embodiments, the outer surfaces of the opposing wings 812 and 814 are further modified to include textures and / or contours to facilitate a user's grip. Finally, where a user wants to hold the device 800 in their hand, the size of the opposing wings 812 and 814 is increased to provide a larger grip surface.
    Referring to Figure 9A, an applicator device 900 is shown. The applicator device 900 comprises a fluid reservoir 910 having a proximal end 912 and a distal end 914. The proximal end 212 includes a cap 920 that seals or otherwise closes the proximal end 912. The distal end 914 is coupled to a fluid dispensing chamber 930 having a first end 932 to receive the distal end 914 of the fluid dispensing chamber 930, and a second end 934 to support an applicator element 940. The rupture or breakable membrane 950 is interposed with fluid reservoir 910 and fluid dispensing chamber 930, thereby preventing antiseptic agent 916 from flowing into fluid dispensing chamber 930 before destroying membrane 950. O device 900 is prepared to fill reservoir 910 with a desired antiseptic agent 916. After filling reservoir 910, cap 920 placed over the proximal end 912 of the shell 910 to seal the agent 916 within the reservoir 910. In some embodiments, the cover 920 is formed by heat pressing the proximal end 912 of the tank 910 thereby forming a seal.
    In some embodiments, the membrane 950 has a disk shape having a uniform depression or grooves 952 that are broken or destroyed by applying lateral force to the membrane 950. For example, in some embodiments the grooves 952 are broken by applying force to the element applicator 940, whereby force is transferred to the membrane 950 through the fluid dispensing chamber 930. In other embodiments, the grooves 952 are broken by compressing or tightening the fluid reservoir 910 to increase the pressure within the reservoir 910 in addition to the resistance of the grooved surface 952. When neutralized, the antiseptic solution 916 inside the reservoir 910 flows through the membrane 950 and is absorbed by the applicator element 940. The thickness of the membrane 950 and the depth of the grooves can vary depending on the desired calculated force to destroy the 950 membrane.
    Referring now to Figure 9B, the illustrated membrane 950 is disk shaped and is configured to fit in a compatible manner within the proximal end 932 of the fluid dispensing chamber 930. In some embodiments, grooves 952 comprise a membrane model featuring a plurality of grooves 960 having varying dimensions and breaking strength. For example, in some embodiments, portions of the membrane 950 are grooved at various depths or graduated depths to provide different resistance to rupture through the membrane 950. Thus, when compressed with a lateral force along the reservoir 910, the membrane 950 breaks along some of the grooved surface 952 and 960 to essentially form a gate valve. Since only some of the grooved surfaces are destroyed, the partially destroyed membrane 950 controls the flow of the antiseptic agent 916 through the membrane 950. However, by applying additional lateral force to the reservoir 910, additional portions of the grooved surfaces 952 and 960 are destroyed thereby increasing the amount of antiseptic agent 916 that can flow through the membrane 950. The present invention can be incorporated in other specific forms without departing from its structures, methods, or other essential features as widely described and hereinafter claimed. The described modalities should be considered in all aspects only as illustrative and not restrictive. The scope of the invention, therefore, is indicated by the appended claims, more properly than by the preceding description. All changes within the meaning and equivalence range of the claims must fall within its scope.
    权利要求:
    Claims (9)
    [1]
    1. An applicator device, comprising: a body (510, 810) comprising a pair of wings (512, 514, 812, 814); a reservoir comprising an ampoule (550, 556, 558, 850) positioned within at least one of the wings (512, 514, 812, 814), the reservoir containing an antiseptic agent (552, 852); an element (540) coupled to an internal lumen (516, 816); where a destructible barrier is provided by the ampoule (550, 556, 558, 850) and where from the activation of the pair of wings (512, 514, 812, 814) the destructible barrier is destroyed and the reservoir and element ( 540) are in fluid communication through the lumen (516, 816) CHARACTERIZED by the fact that the internal lumen (516, 816) is comprised of interconnected lumens located on the first wing (512, 812) and the second wing (514, 814).
    [2]
    2. Device, according to claim 1, CHARACTERIZED by the fact that it also comprises a wedge tip (560, 570, 580, 596) positioned interposed between the pair of wings (512. 514, 812, 814), wherein from the activation of the pair of wings (512, 514, 812, 814), the wedge tip (560, 570, 580, 814) destroys the destructible barrier.
    [3]
    3. Device, according to claim 2, CHARACTERIZED by the fact that the reservoir is positioned on each of the wings (512, 514, 812, 814).
    [4]
    4. Device, according to claim 3, CHARACTERIZED by the fact that from the activation of the wings (512, 514, 812, 814), the wedge point (560, 570, 580, 596) opens the first and the second reservoirs, thereby releasing antiseptic and liquid agents (552, 852) into the internal lumens (516, 816) and for contact with the applicator element (540).
    [5]
    5. Device according to claim 3 or 4, CHARACTERIZED by the fact that the first and second reservoirs are glass ampoules (550, 556, 558, 850).
    [6]
    6. Device according to any one of claims 3 to 5, CHARACTERIZED by the fact that the wedge tip (560, 570, 580, 596) comprises a first contact (592) coupled to a second contact (594) via spacer (596) to open the first reservoir before opening the second reservoir.
    [7]
    7. Device according to claim 1, CHARACTERIZED by the fact that the body (510, 810) comprises a semi-flexible material, in which from the compression of the body (510, 810), the destructible barrier is destroyed.
    [8]
    8. A method for manufacturing an applicator device, comprising: providing a body (510, 810) comprising a pair of wings (512, 514, 812, 814) having a lumen (516, 816); positioning a reservoir comprising an ampoule (550, 556, 558, 850) providing a destructible barrier in which the reservoir is positioned on at least one of the wings (512, 514, 812, 814), the reservoir containing the antiseptic agent (552 , 852); couple an element to the lumen (516, 816), in which from the activation of the pair of wings (512, 514, 812, 814), the destructible barrier is destroyed and the reservoir and element (540) are placed in communication of fluid with each other through the lumen (516, 816), CHARACTERIZED by the fact that the internal lumen is comprised of interconnected lumens located within the first wing and the second wing.
    [9]
    9. Method, according to claim 8, CHARACTERIZED by the fact that the body (510, 810) comprises a semi-flexible material, in which from the compression of the body (510, 810), the destructible barrier (550) is destroyed .
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    同族专利:
    公开号 | 公开日
    WO2011034665A1|2011-03-24|
    US8348913B2|2013-01-08|
    JP5632478B2|2014-11-26|
    AU2010295916A1|2012-03-22|
    ES2599070T3|2017-01-31|
    EP2477687A1|2012-07-25|
    AU2010295916B2|2015-03-26|
    BR112012005863A2|2016-02-16|
    CN102497908B|2014-10-01|
    EP3108922B1|2018-06-13|
    IN2012DN02023A|2015-08-21|
    JP2013504404A|2013-02-07|
    CN102497908A|2012-06-13|
    EP3108922A1|2016-12-28|
    US20110066121A1|2011-03-17|
    ES2687193T3|2018-10-24|
    EP2477687B1|2016-07-20|
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    法律状态:
    2019-01-15| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-09| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2019-11-05| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2019-12-03| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/08/2010, OBSERVADAS AS CONDICOES LEGAIS. (CO) 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/08/2010, OBSERVADAS AS CONDICOES LEGAIS |
    优先权:
    申请号 | 申请日 | 专利标题
    US24244509P| true| 2009-09-15|2009-09-15|
    US12/846,530|US8348913B2|2009-09-15|2010-07-29|Systems and methods for providing an antiseptic applicator|
    PCT/US2010/044431|WO2011034665A1|2009-09-15|2010-08-04|Systems and methods for providing an antiseptic applicator|
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