专利摘要:
MEDICAL DEVICES INCLUDING BOTTLE ADAPTER WITH INLINE DRY DRUG MODULE. The present invention relates to medical devices that include a vial adapter (32) with an in-line dry drug module (33) for use with a vial (20), a needleless syringe (10) and a liquid carrier ( 26) to fill the needleless syringe with an injection solution for injection into a patient. The in-line dry drug modules (33) include a dry drug storage component (57) for storing a dosage of dry drug and a uniform liquid carrier delivery component (58) to promote uniform contact of the storage component with dried drug by the liquid carrier to form an injection solution from the dry drug dosage. In-line dry drug modules can include a separate dry drug storage component and a separate liquid carrier liquid delivery component or a dual purpose component not only for drug storage but also for uniform liquid carrier delivery. . The vial adapter can be provided in vented or non-vented versions.
公开号:BR112015027555B1
申请号:R112015027555-9
申请日:2014-05-05
公开日:2022-02-01
发明作者:Hugh Zachary Marks;Nimrod Lev;Amir Lev
申请人:Medimop Medical Projects Ltd;
IPC主号:
专利说明:

Field of Invention
[0001] The present invention pertains to medical devices with an in-line dry drug module that includes a dry drug dosage for use with a liquid source for parenteral administration to a patient. Background of the invention
[0002] Medical treatments often involve parenteral administration of liquid drugs to the human body. Liquid drugs can be in the form of solutions, suspensions, and the like. Some reagent drugs have extended shelf lives in a dry state and only a short shelf life after reconstitution or rehydration.
[0003] US Patent No. 6,520,932 to Taylor describes an in-line drug shipping package 35 that connects in-line with an IV IV line and allows mixing of the diluent with a reagent drug to be shipped to a patient. The drug shipping package includes a housing 37 with a reagent bed 110 consisting of a fluid soluble material suitable for administration to a patient via dissolution and IV drip. The housing includes radial inlet fins 65 which cooperate with back pressure from an inlet frit 80 to promote even distribution of diluent across the entire cross-section of the drug delivery package. An internal drug bed bypass mechanism is provided to split the diluent flow between the bypass and the drug bed to achieve a solution concentration suitable for IV administration as the dry reagent is dissolved.
[0004] US Patent No. 6,951,613 to Reif et al., describes a genetic vaccination device and a process for forming an injection solution therefor. The device includes a syringe 2 and a cannula 3 coupled to an in-line membrane absorber (5) having genetic material adsorbed thereto. The process includes eluting the genetic material from the absorber membrane to form an injection solution containing the genetic material.
[0005] US Patent Application Publication No. US2008/0294100 to de Costa et al. describes a pharmaceutical device for administering substrates to a patient. Costa's pharmaceutical device is similar to the aforementioned Reif genetic vaccination device in that it includes an in-line porous membrane supporting a water-soluble glassy material and having biological materials such as vaccines stabilized therein so that when the biological material requires administration, the eluent can be passed through the membrane dissolving the glass and causing the substance to be carried by the liquid into the patient.
[0006] Reif's Genetic Vaccination Device and Costa's Pharmaceutical Device are relatively cumbersome and inconvenient to handle when injecting an injection solution into a patient. Furthermore, the device housings thereof containing the dry drug dosage to be injected into a patient necessarily impose injections at greater injection angles into a patient's body than is usual.
[0007] There is a need for medical devices with an in-line dry drug module to facilitate the injection of an injection solution to a patient. Summary of the invention
[0008] The present invention is directed to medical devices that include a vial adapter with an in-line dry drug module having a dry drug dosage for use with a needleless syringe and a vial for filling the needleless syringe with a solution of injection formed from the dosage of dry drug for injection into a patient. Medical devices are preferably used with an initially empty needleless syringe and a vial initially filled with a liquid carrier. Alternatively, the medical device may be used with a syringe initially pre-filled with a liquid carrier and an initially empty vial. The liquid carrier may be diluent alone or alternatively it may include an active component.
[0009] The vial adapter has a similar construction as commercially offered vented or non-vented vial adapters except for the in-line dry drug modules. In-line dry drug modules include a dry drug storage component for storing a dosage of dry drug and a uniform liquid carrier delivery component to promote uniform contact of the dry drug storage component with the liquid carrier to form the injection solution. The dry drug storage component and the uniform liquid carrier delivery component can be two distinct components. Alternatively, the two components can be combined into a single component with two objectives.
[00010] In-line dry drug modules can employ any of a number of commercially offered technologies to allow long-term storage of a dry drug dosage for subsequent formation into an injection solution on contact by the liquid vehicle. Suitable technologies commercially offered are, among other things, discussed in the prior art references mentioned in the Background of the present invention. The different technologies include, among other things, liquid carrier flowing through a porous substrate to dissolve or capture a dosage of dry drug, liquid carrier flowing across a surface of the substrate to dissolve or capture a dosage of dry drug, and the like.
[00011] The use of medical devices of the present invention with an initially empty needleless syringe and an initially filled vial involves a single aspiration. Alternatively, use of the medical devices of the present invention with an initially filled syringe and an initially empty vial requires an initial injection of a liquid carrier from the syringe into the vial and subsequent aspiration from the vial into the syringe. The first use takes less time while the last use can provide greater certainty regarding the complete use of a dry drug dosage.
[00012] The medical devices of the present invention provide a convenient, low-cost solution for the preparation of needleless syringes for the injection of injection solutions to patients. The medical devices of the present invention are particularly suitable for use with so-called thermostable drugs and reagents which have a relatively long shelf life at ambient temperatures thereby negating the need for refrigeration. Suitable drugs and reagents include, among other things, vaccines, and the like. Brief Description of Drawings
[00013] In order to understand the present invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which like parts are numbered therefrom. 1 is an illustrative view of an initially empty needleless syringe, a vial, and a first embodiment of a vented medical device in accordance with the present invention for filling the initially empty needleless syringe with an injection solution; figure 2 is a perspective bottom view of the medical device of figure 1; figure 3 is a side elevational view of the medical device of figure 1; figure 4 is a longitudinal cross-sectional view of the device figure 1 along the line A-A in figure 3; figure 5 is an exploded view of the medical device of figure 1; figure 6 is a perspective bottom view of a vehicle delivery component. uniform liquid volume of the medical device of Figure 1; Figure 7A shows an inverted assembly of the initially empty needleless syringe, the medical device of Figure 1 and the vial prior to aspiration of liquid carrier from the vial into the needleless syringe; Figure 7B shows the inverted assembly subsequent to partial aspiration of the liquid carrier from the vial into the needleless syringe; Figure 7C shows the inverted assembly with the needleless syringe filled with the injection solution for administration to a patient; the figure 8 is a longitudinal cross-sectional enlargement of the circled section of the assembly of Figure 7B showing the flow of liquid carrier from the vial to the syringe during aspiration; Figure 9 is an exploded view of a second embodiment of a medical device. vented according to the present invention; and Fig. 10 is a perspective bottom view of a uniform liquid carrier dispensing component of Fig. 9 medical device. Detailed Description of the Drawings
[00014] Figure 1 shows an empty needleless syringe 10, a vial 20 and a vented medical device 30 for use to fill the needleless syringe 10 with an injection solution for injection into a patient. The syringe 10 includes a barrel portion 11 with a plunger rod 12 and a syringe tip 13. The vial 20 includes a bottle-type vial 21 sealed by a vial cap member 22. The bottle-type vial 21 typically includes an aluminum seal 23 to secure vial cap member 22 to bottle type vial 21. Bottle type vial 21 has an inner vial 24 containing a liquid carrier 26. Liquid carrier 26 may be diluent only. . Alternatively, the liquid carrier 26 may include an active component.
[00015] Figures 1 to 6 show the medical device 30 having a longitudinal centerline of the device 31 and includes a vial adapter 32 with an in-line dry drug module 33. The vial adapter 32 includes a skirt portion 34 having a transverse top skirt portion wall 36 and downwardly hanging flexible members 37 for telescopic mounting onto the vial 20. The top skirt portion wall 36 is formed with a center skirt portion hub 38 coaxial with the top skirt portion 36. axis of longitudinal device 31 with six equidistantly spaced radial ribs 39 extending outwardly therefrom. The hub of the central skirt portion 38 is formed with a liquid transfer port 41 coaxial with the axis of the longitudinal device 31 and a ventilation port 42 offset with respect to the axis of the longitudinal device 31.
[00016] Vial adapter 32 includes a top cover portion 43 having a central vertical female connector 44 coaxial with the longitudinal centerline of device 31 for sealing connection with syringe tip 13. Syringe tip 13 is preferably a male Luer locking connector and the central vertical female connector 44 is a female Luer connector for threaded mounting of needleless syringe 10 to medical device 30. Alternatively, syringe tip 13 and female connector 44 may be formed with other connectors.
[00017] The vial adapter 32 includes a downwardly-pending puncture cannula 46 coaxial with the longitudinal device 31 for puncturing the vial cap member 22 for flow communication with the inner vial 24 in the telescopic mount of the medical device 30 in the vial 20. Cannula 46 includes a liquid transfer light 47 in flow communication with the liquid transfer port 41 and a vent light 48 in flow communication with the vent port 42.
[00018] The vial adapter 32 includes a filter cover 49 for placement between the top cover portion 43 and the wall of the top skirt portion 36. The filter cover 49 encloses an air filter 51 disposed in the ribs 39. The air filter 51 has a central air filter opening 52 coaxial with the axis of the longitudinal device 31. The filter cover 49 includes a central opening of the filter cover 53 coaxial with the axis of the longitudinal device 31 and a peripheral edge of filter cover 54 formed with a plurality of ventilation openings 56.
[00019] The in-line dry drug module 33 is arranged in-line between the central vertical female connector 44 and the puncture cannula 46 and in particular the liquid transfer port 41. The in-line dry drug module 33 includes a dry drug storage member 57 proximate the vertical female connector 44 and distal from the puncture cannula 46. The in-line dry drug module 33 further includes a uniform liquid carrier delivery component 58 proximate the puncture cannula 46 and distal from vertical female connector 44.
[00020] The dry drug storage component 57 is preferably formed as a disk-shaped substrate formed from a wide variety of suitable inert porous biocompatible materials that allow the liquid carrier 26 to flow therethrough. Suitable materials include, among other things, fiberglass, fiber plastic, and the like. Dry drug storage component 57 is provided with a dry drug dosage 59 for administration to a patient. The dry drug dosage 59 may be in the form of very fine particles, and the like, to allow reconstitution of an injection solution by capturing the liquid carrier 26 through the dry drug storage component 57.
[00021] The uniform liquid vehicle delivery member 58 is preferably formed as a disk-shaped member having a uniform liquid vehicle delivery member on the top side 58A facing the vertical female connector 44, a vehicle delivery component uniform liquid on the underside 58B facing the puncture cannula 46, and a peripheral edge of the uniform liquid carrier dispensing member 61. The underside of the uniform carrier dispensing member 58B is formed with a series of radial grooves 62 each of which terminates in a cut 63 in the peripheral edge of the uniform liquid carrier dispensing member 61 to allow flow communication from the underside of the uniform liquid carrier dispensing member 58B to the upside of the uniform liquid vehicle distribution component 58A.
[00022] The use of the medical device 30 for use in preparing the needleless syringe 10 with an injection solution for injection into a subject is now described with reference to Figures 7A through 7C and Figure 8 which is an enlargement of the circled area denoted A in figure 7B:
[00023] Figure 7A shows a user telescopically mounting the medical device 30 onto the vial 20 to puncture the vial cap member 22. The user attaches the needleless syringe 10 to the female connector 44. The user reverses the assembly. so that vial 20 sits above needleless syringe 10 and begins to draw liquid carrier 26 from vial 20 into needleless syringe 10.
[00024] Figure 7B and Figure 8 show the flow of the liquid carrier 26 from the vial 20 to the initially empty needleless syringe 10 as follows: the liquid carrier 26 flows downwards along the liquid transfer light 47 to the underside of the uniform liquid vehicle delivery member 58B. The liquid carrier 26 flows radially outward from the underside center of the uniform liquid carrier dispensing member 58B along the radial grooves 62 to the peripheral edge of the uniform liquid carrier dispensing member 61.
[00025] Liquid carrier 26 flows downwards through cuts 63 and then radially inwardly through porous dry drug storage member 57 to capture the dry drug dosage 59 therewith to form an injection solution 64. During the aspiration of the liquid carrier 26 from the vial 20 into the syringe 10, air is drawn through the vents 56, the air filter 51 and the vent light 48 into the vial 20 as indicated by the air bubbles in the liquid vehicle 26.
[00026] Figure 7C shows the syringe 10 filled with an injection solution 64 ready for injection to an individual after disconnecting from the female connector 44 and attaching the needle
[00027] Figure 9 shows a ventilated medical device 70 similar in construction and operation to the ventilated medical device 30 and therefore similar parts are numbered in the same way. The latter 70 differs from the former 30 in that its in-line dry drug module 33 includes a single dual-purpose component 71 which acts as both a dry drug dosage storage component and a delivery component. of uniform liquid vehicle. Dual purpose component 71 has a similar construction to uniform liquid vehicle delivery member 58 in that it includes a top side of uniform liquid vehicle delivery component 71A facing female connector 44, one side bottom of the uniform liquid vehicle delivery member 71B facing the puncture cannula 46 and a peripheral edge of the uniform liquid vehicle delivery member 72. The top side of the uniform liquid vehicle delivery member 71A has a dry drug dosage liner 73 which constitutes a dry drug dosage storage component. The underside of the uniform vehicle delivery member 71B is formed with a series of radial grooves 62 each of which terminate in a cut 63 in the peripheral edge of the uniform liquid vehicle delivery member 72 to allow flow communication to from the underside of the uniform liquid carrier dispensing component 71B to the upside of the uniform liquid carrier dispensing component 71A.
[00028] While the present invention has been described with respect to a limited number of embodiments, it will be understood that many variations, modifications, and other applications of the present invention may be realized within the scope of the appended claims.
权利要求:
Claims (6)
[0001]
1. Medical device for use with a needleless syringe, a vial and a liquid carrier for filling the needleless syringe with an injection solution for injection into a patient, the needleless syringe having a male connector, the vial having a vial cap and an inner vial, the medical device having a longitudinal centerline of the device and comprising: (a) a vial adapter having a skirt with flexible members that hang downwards for telescopic mounting on the vial, a puncture cannula for the puncture of the vial cap element in said telescopic type assembly for flow communication with the inner vial and a central vertical female connector in flow communication with said puncture cannula and intended for connection to the male connector; characterized by the fact that: (b) an in-line dry drug module disposed in-line between said female connector and said puncture cannula, said in-line dry drug module which includes a dry drug storage component that stores a dry drug dosage and a uniform liquid carrier delivery component to promote uniform contact of said dry drug storage component with said liquid carrier in the suction of liquid carrier from the liquid carrier. vial through the in-line dry drug module directly into the needleless syringe to form the injection solution.
[0002]
2. The device of claim 1, wherein said in-line dry drug module includes a separate dry drug storage component for storing said dry drug dosage and a separate liquid carrier delivery component. uniform to promote said uniform contact.
[0003]
Device according to claim 1, characterized in that said in-line dry drug module includes a dual-purpose component for storing said dry drug dosage and also for promoting said uniform contact.
[0004]
Device according to claim 3, characterized in that the uniform liquid vehicle component includes an upside of the uniform liquid vehicle component facing said female connector, an underside of the vehicle distribution component uniform liquid facing said puncture cannula and a peripheral edge of the uniform liquid carrier delivery component, wherein said top side of the uniform liquid carrier delivery component has a dry drug dosage coating constituting the delivery component. dry drug storage.
[0005]
Device according to claim 4, characterized in that the underside of the uniform liquid vehicle delivery component is formed with a series of radial grooves each of which ends in a cut in the peripheral edge of the component of distribution. uniform liquid carrier delivery to allow flow communication from the underside of the uniform liquid carrier delivery component to the upside of the uniform liquid carrier delivery component on aspiration of the needleless syringe to sip the liquid content at from the vial through the in-line dry drug module directly into the needle-free syringe.
[0006]
Device according to any one of claims 1 to 3, characterized in that said uniform liquid vehicle component includes a top side of the uniform liquid vehicle component facing said female connector, a side of bottom of the uniform liquid carrier dispensing member facing said puncture cannula and a peripheral edge of the uniform liquid carrier dispensing member, said underside of the uniform liquid carrier dispensing member having a plurality of radial grooves each of which terminating in a cut in said peripheral edge of the uniform liquid carrier dispensing member thereby allowing the liquid carrier to flow from said underside of the uniform liquid carrier dispensing member to said upside of the liquid carrier component. even distribution of liquid vehicle in the aspiration of the needleless syringe to sip the liquid contents fluid from the vial through the in-line dry drug module directly into the needleless syringe.
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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2020-02-04| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2021-11-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2022-02-01| 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 05/05/2014, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US201361821760P| true| 2013-05-10|2013-05-10|
US61/821,760|2013-05-10|
PCT/IL2014/050405|WO2014181328A1|2013-05-10|2014-05-05|Medical devices including vial adapter with inline dry drug module|
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