Source: http://patents.com/us-9889260.html
Timestamp: 2019-01-21 15:43:51
Document Index: 18686731

Matched Legal Cases: ['Application No. 201380023499', 'art.\n6', 'art.\n7', 'art.\n9', 'Application No. 12168374', 'art 604', 'art 606', 'art 604', 'art 606', 'art 604', 'art 604', 'art 604', 'art 604', 'art 604', 'art 606', 'art 606', 'art 606', 'art 606', 'art 606', 'art 604', 'art 604', 'art 604', 'art 604', 'art 606', 'art 606', 'art 606', 'art 606']

United States Patent 9,889,260
Laugere , et al. February 13, 2018
The invention relates to a dispense interface comprising a body comprising at least a first channel structure and a second channel structure, wherein each of the at least two channel structures comprises at least a first inlet channel comprising a first inlet opening and a second inlet channel comprising a second inlet opening, wherein each of the at least two inlet openings of one channel structure is configured for fluid communication with a respective reservoir of at least two reservoirs and wherein at least one connecting channel configured for a fluid communication between at least one outlet opening and one of the at least two channel structures is provided.
Laugere; Frederic (Bedfordshire, GB), Popa; Cristian (Norfolk, GB), Impey; Ben (Cambridgeshire, GB), MacLeod; Andrew (Cambridgeshire, GB)
Family ID: 1000003113678
14/395,993
PCT/EP2013/060164
WO2013/171311
US 20150320942 A1 Nov 12, 2015
May 16, 2012 [EP] 12168374
Current CPC Class: A61M 5/3294 (20130101); A61M 5/1407 (20130101); A61M 5/16827 (20130101); A61M 5/31596 (20130101); A61M 5/329 (20130101); A61M 39/223 (20130101); A61M 5/19 (20130101); A61M 2005/3128 (20130101)
Current International Class: A61M 5/32 (20060101); A61M 39/22 (20060101); A61M 5/315 (20060101); A61M 5/19 (20060101); A61M 5/168 (20060101); A61M 5/14 (20060101); A61M 5/31 (20060101)
5417667 May 1995 Tennican et al.
5478323 December 1995 Westwood
5916201 June 1999 Wilson et al.
7416540 August 2008 Edwards
2008/0147014 June 2008 Lafferty
101400390 Apr 2009 CN
101945678 Jan 2011 CN
94/22507 Oct 1994 WO
International Search Report for Int. App. No. PCT/EP2013/060164, completed Aug. 9, 2013. cited by applicant .
Chinese Office Action for CN Application No. 201380023499.1, dated Jun. 3, 2016. cited by applicant.
1. A dispense interface comprising: a body comprising at least a first channel structure and a second channel structure, wherein the first channel structure comprises at least a first inlet channel comprising a first inlet opening and a second inlet channel comprising a second inlet opening, wherein the second channel structure comprises at least a third inlet channel comprising a third inlet opening and a fourth inlet channel comprising a fourth inlet opening, wherein the first inlet opening of the first channel structure is configured for fluid communication with a first reservoir and the second inlet opening of the first channel structure is configured for fluid communication with a second reservoir, wherein the third inlet opening of the second channel structure is configured for fluid communication with a third reservoir and the fourth inlet opening of the second channel structure is configured for fluid communication with a fourth reservoir, and wherein at least one connecting channel configured for a fluid communication between at least one outlet opening and one of the at least two channel structures is provided in such a way that only one channel structure is in fluid communication with the outlet opening at the same time, wherein at least one separate member comprising at least the at least one connecting channel and the at least one outlet opening is provided, wherein the at least one separate member is configured for a fluid tight connection with the body.
2. The dispense interface according to claim 1, wherein a first double-ended needle assembly comprising at least a first double-ended needle and a second double-ended needle is provided, wherein the first double-ended needle assembly is configured for a fluid tight connection with the at least two inlet openings of one channel structure.
3. The dispense interface according to claim 1, wherein the body is formed as a cylinder comprising a distal end surface and a proximal end surface, wherein the at least two inlet openings of at least one channel structure are arranged at an edge region of the proximal end surface.
4. The dispense interface according to claim 3, wherein the at least two inlet openings of at least one channel structure are arranged on a straight line which passes the center of the proximal end surface.
5. The dispense interface according to claim 1, wherein the body comprises at least a first part and a second part, wherein the first part is a cylindrical axis comprising the at least one outlet opening and the at least one connecting channel and wherein the second part comprising at least the first channel structure and the second channel structure is at least rotatably mounted on the first part.
6. The dispense interface according to claim 5, wherein the first part comprises a first double-ended needle assembly, wherein the first double-ended needle assembly is arranged at the proximal end of the first part in such a way that the first double-ended needle assembly is tightly connectable with the at least two inlet openings of one channel structure of the second part.
7. The dispense interface according to claim 5, wherein a stop element is arranged at the distal end of the first part, wherein at least one elastic element is arranged between the stop element and the second part and wherein the elastic element is configured to exert a force onto the second part into a proximal direction.
8. The dispense interface according to claim 7, wherein the second part is configured for releasing the fluid tight connection between the first double-ended needle assembly and the at least two inlet openings of a first channel structure by a movement in a distal direction and wherein the second part is configured for establishing a fluid tight connection between the first double-ended needle assembly and the at least two inlet openings of a second channel structure by a rotational movement and a movement in a proximal direction of the second part.
9. The dispense interface according to claim 1, wherein at least one inlet opening is sealed by a pierceable material.
10. The dispense interface according to claim 1, wherein at least one part of the body is produced by injection molding.
11. The dispense interface according to claim 1, wherein at least one non-return valve is provided.
12. A system comprising: a dispense interface according to claim 1, and an ejection device, wherein the dispense interface is attachable to the ejection device.
13. A method for using a dispense interface according to claim 1 comprising the steps of: attaching a first double ended needle assembly to the inlet openings of one channel structure of the dispense interface and attaching the dispense interface to an ejection device having at least two reservoirs such that a fluid tight connection is established between the at least two reservoirs and one channel structure of the dispense interface.
14. The method according to claim 13, further comprising the steps of: ejecting a fluid from at least one of the reservoirs through the dispense interface and removing the dispense interface from the ejection device.
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. .sctn.371 of International Application No. PCT/EP2013/060164 filed May 16, 2013, which claims priority to European Patent Application No. 12168374.2 filed May 16, 2012. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
The dispense interfaces in the state of the art are, however, often of complex design. In order to provide the manifold to lead the medicaments from two different reservoirs to a single outlet, multiple complex and/or small parts need to be produced and assembled. A dispense interface in the state of the art normally has one channel structure with at least two inlet channels.
The dispense interface is regularly kept at the drug delivery device for a longer period of time. This means that only the dose dispenser in form of a double ended needle, for instance, is exchanged for every or nearly every injection procedure. The dispense interface, however, remains at the drug delivery device. The same channel structure is used a plurality of times. An exchange of the dispense interface itself is regularly only necessary, when the reservoirs of the drug delivery device need to be exchanged.
This causes requirements for the material and design of the dispense interface to be fulfilled. Since the drug agents from the first and/or the second reservoir remain inside the dispense interface, e.g. in the inlet channels of the channel structure, after a dispense procedure, a material compatibility of these parts of the dispense interface being in contact with the drug agents needs be to provided. No harmful substances must diffuse into the drug agents, since these would then be delivered to the patient with the next delivery procedure. Hence a biocompatibility is required, which guarantees that either no or negligible amounts of substances can diffuse into drug agents or are set free into the liquid.
Another option for guaranteeing that either no or only negligible amounts of substances can diffuse into drug agents or are set free into the liquid is the use of single use dispense interfaces. In particular, a dispense interface is used for only one ejection or injection procedure. In this case, the drug is in contact with parts of the dispense interface, like the inlet channel, for a short time period. Due to the short time period, either no or negligible amounts of substances can diffuse into the drug agents. However, an obvious disadvantage of single use dispense interfaces is that after every ejection procedure the used dispense interface has to be disposed. In particular, for environmental reasons single use dispense interfaces should be avoided.
In light of the aforementioned, the invention faces the technical problem of material compatibility and cross contamination and at the same time, overcoming the environmental problems.
The technical problem is solved by a dispense interface comprising a body comprising at least a first channel structure and a second channel structure, wherein each of the at least two channel structures comprises at least a first inlet channel comprising a first inlet opening and a second inlet channel comprising a second inlet opening, wherein each of the at least two inlet openings of one channel structure is configured for fluid communication with a respective reservoir of at least two reservoirs and wherein at least one connecting channel configured for a fluid communication between at least one outlet opening and one of the at least two channel structures is provided.
By providing a body comprising at least two channel structures, wherein each channel structure is preferably configured for (only) one ejection procedure, the dispense interface can be used at least for two ejections. More particularly, a multi-use dispense interface with a plurality of single-use channel structures can be provided. The discarding of the dispense interface after every ejection can be avoided, which is advantageous in view of environmental reasons.
The dispense interface is particular suitable for an ejection device. Furthermore, the production of the dispense interface is also more cost-efficient than the production of single use dispense interfaces since it is not required to produce a plurality of single-use dispense interfaces. Merely one multi-use dispense interface with a plurality of single-use channel structures can be produced. As a consequence, the total productions costs and efforts are reduced.
During an ejection procedure a liquid may enter the dispense interface through the first inlet opening of a first channel structure and another liquid may enter the dispense interface through the second inlet opening of the first channel structure. Guided by the respective inlet channels of the first channel structure and the connecting channel, the liquids can leave the dispense interface via the outlet opening. The dispense interface can thus be seen as a manifold.
Since a channel structure of the dispense interface is only in connection with the reservoirs of the ejection device substantially during the ejection procedure, there is only a short time for possible substances or chemicals in the dispense interface to diffuse into the liquid ejected by the ejection device and guided through the inlet, connecting and/or outlet channels.
There is also substantially no time for the liquids within the reservoirs to become cross-contaminated, since each channel structure is preferably used for only one ejection. After all channel structures has been used for a respective number of ejection procedures, the dispense interface can be discarded.
It shall be understood that, generally, every channel structure can also be used for two or more ejections.
As a consequence of the above mentioned, an easy usage of a multi-use dispense interface is provided and at the same time the problems of material compatibility and cross contamination as well as environmental problems are overcome.
According to an embodiment of the dispense interface according to the invention, at least one separate member comprising at least the at least one connecting channel and the at least one outlet opening is provided, wherein the separate member is configured for a fluid tight connection with the body. For instance, suitable connecting elements are provided for establishing a fluid tight connection between the body and the separate member. Thereby, the connecting channel can be configured for a fluid connection between an outlet of the first inlet channel and an outlet of the second inlet channel of one channel structure. Thereby, the separate member, in particular, the connecting channel, may be configured to establish a respective fluid communication with all channel structures of the body.
Furthermore, the outlet opening of the separate member may be provided with a further connecting element configured for a connection with a second needle assembly. The second needle assembly attached to the separate member, corresponding to the outlet opening, can serve as a dose dispenser comprising an injection needle, for example. Preferably, the separate member can be a single-use item. After the ejection procedure, the separate member can be disconnected from the multi-use body. Preferably, the separate member is used for only one ejection procedure.
In another embodiment of the dispense interface according to the invention, a first double-ended needle assembly comprising at least a first double-ended needle and a second double-ended needle is provided, wherein the first double ended needle assembly is configured for a fluid tight connection with the at least two inlet openings of one channel structure. For instance, the double ended needle assembly is a separate component. The body may have at least one connecting element corresponding to at least one connecting element of the first double-ended needle assembly for securely connecting the respective components to each other. The first double-ended needle assembly may comprise a first piercing needle and a second piercing needle. The first and second needle may correspond to the first and second inlet opening of one channel structure, respectively. The needles can be inserted into the respective openings.
In particular, double ended needles are provided. The needles may be configured to pierce for example the septa of the corresponding reservoirs. The needles of the first double ended needle assembly may guide the liquids of the reservoirs to the first and second opening of one channel structure of the dispense interface.
The first double ended needle assembly may be a single use item. After the ejection process, the first double-ended needle assembly can be disconnected from the body. Preferably, the first double-ended needle assembly is used for only one ejection procedure.
Furthermore, according to another embodiment of the dispense interface of the invention, the body is formed as a cylinder comprising a distal end surface and a proximal end surface, wherein at least two inlet openings of at least one channel structure are arranged at an edge region of the proximal end surface. In particular, the body may be a drum. Preferably, all inlet openings of the respective channel structures are arranged at the edge region of the proximal end surface. The end surfaces may have a circular shape. The distances between the respective two inlet openings of each channel structure may be substantially equal. The distance between the two openings of one channel structure, preferably of each channel structure, may correspond to the distance of the first and second reservoir of the ejection device. All channel structures can be easily connected with the respective reservoirs, for instance, by a first double ended needle assembly.
In particular, according to a further embodiment, the at least two inlet openings of at least one channel structure are arranged on a straight line which passes the center of the proximal end surface. By the arrangement of the inlet openings on a straight line which passes the center of the proximal end surface at the edge region of a circular surface, the provided surface can be used efficiently. In particular, all openings may be arranged on a circular path of the drum.
According to another preferred embodiment of the dispense interface of the invention, the body comprises at least a first part and a second part, wherein the first part provides a cylindrical axis on which a second cylindrical part can be mounted, the first part comprising the at least one outlet opening and the at least one connecting channel and wherein the second part comprises at least the first channel structure and the second channel structure. By providing a second part comprising two or more channel structures rotatably mounted on the first part, a user can easily switch from a first channel structure to a second channel structure, for instance after an ejection procedure. By providing a first part in the form of a longitudinal axis and a second part rotatably mounted on this axis, the user can switch between at least two channel structures by simply rotating the second part. An easy and user-friendly handling of the dispense interface can be provided.
Preferably, all inlet openings of the respective channel structures are arranged at the edge region the proximal end surface of the second part. The distance between the two openings of one channel structure, preferably of each channel structure, may correspond to the distance of the first reservoir and second reservoir of the ejection device. All channel structures can be easily connected with the respective reservoirs, for instance, by a first double ended needle assembly.
It is further preferred that the first part comprises a first double-ended needle assembly, wherein the first double-ended needle assembly is arranged at the proximal end of the first part in such a way that the first double-ended needle assembly is tightly connectable with the at least two inlet openings of one channel structure of the second part. The first double ended needle assembly may be formed as an integral component of the first part. The double ended needle assembly may be designed in such a way that it can be used for a plurality of ejections. In particular, the double ended needle can be configured to be used at least as often as corresponds to the number of channel structures in the second part. A suitable material can be used with a required biocompatibility. The first double ended needle assembly can be configured for a fluid connection between a first reservoir and a first inlet opening of a channel structure and for a fluid connection between a second reservoir and a second inlet opening of the channel structure.
According to a further embodiment, a stop element is arranged at the distal end of the first part, wherein at least one elastic element is arranged between the stop element and the second part and wherein the elastic element is configured to exert a force onto the second part into the proximal direction. By providing an elastic element which exerts a force in the proximal direction, in particular along the axis of the first part, it can be ensured that a fluid tight connection is formed between the first double-ended needle assembly and the openings of at least one channel structure. The elastic element is preferably a spring, in particular, a helical spring. A helical spring can be easily mounted on the first part between the second part and the stop element.
According to another embodiment, the second part is configured to release the fluid tight connection between the first double-ended needle assembly and the at least two inlet openings of a first channel structure by a movement in a distal direction. The second part is further configured to establish a fluid tight connection between the first double-ended needle assembly and the at least two inlet openings of a second channel structure by a rotational movement and a movement in a proximal direction of the second part. The user can switch from a first channel structure to a second channel structure in a simple way. For instance, in a first step, the user can push the second part into the distal direction of the dispense interface along the axis of the first part. Thereby, the force to be exerted by the user must be larger than the force exerted by the at least one elastic element. If the needles of the first double-ended needle assembly are exposed, the second part can be freely rotated. In particular, the user can rotate the second part until the first and second inlet opening of an e.g. unused channel structure is located opposite the respective needles of the first double ended needle assembly. If the user releases the second part, the force exerted by the elastic element causes that the respective needles to enter the respective inlet openings and a fluid tight connection is established. An easy and user-friendly handling of the dispense interface can be provided.
Furthermore, it is preferred that at least one inlet opening is sealed by a pierceable material. For instance, a rubber seal or a film can be provided. The material of the film or layer may be metal, polymer and/or biopolymer. Preferably, a layer is bonded to the distal end surface comprising the at least one inlet opening. For instance, adhesive bonding techniques and/or thermal bonding techniques, such as fusion or laser techniques, can be used. In particular, all inlet openings are sealed by a pierceable material. A sealing layer can prevent particles from entering into a channel structure, in particular an unused channel structure. Furthermore, a user can recognize which channel structures have already been used and which are still unused.
According to a further embodiment, at least one part of the body is produced by injection molding. With this manufacturing process at least one of the parts can be produced from plastic, such as a thermoplastic or a thermosetting material. It is preferred that both or all parts are produced from plastic. This reduces the operating expenses and costs of the manufacturing process of the dispense interface making it suitable for a low cost multi use component.
When the inlet and connecting channels are configured such that a liquid can flow freely from any region of higher pressure to any region of lower pressure, the dispense interface is particularly easy and cost efficient to manufacture. No components, in particular valves, are provided in the inlet and connecting channels, which would increase the efforts and expenses during the manufacture of the dispense interface. The risk of a cross-contamination or a diffusion of substances into the liquid guided with the dispense interface is counteracted by the fact that one channel structure of the dispense interface can be only used for one ejection procedure. Hence, there is only a short period of time, in which the guided liquid and the respective channel structure of the dispense interface are in contact reducing the risk of any contaminations of the dispense interface.
Alternatively, it is also possible, that at least one non return valve is provided. In particular, the connecting channel may comprise such a valve. This prevents or minimizes the back flow of a fluid back into one of the reservoirs. Additionally, the common volume can be reduced, in which both fluids from the reservoirs mix. This is advantageous, in case the user forgets to remove the dispense interface from the ejection device. In that case a cross-contamination can still be prevented. Especially, when the fluids are ejected one after another, the risk of a cross-contamination is higher, since there is a reduced counter pressure for the fluid from the one reservoir to enter the other reservoir compared to when both fluids are ejected simultaneously. Preferably, either a valve, such as a diaphragm valve, for each the first and the second inlet channels is provided or a valve, such as a shuttle valve, which prevents backflow in both the first and the second inlet channels is provided. In case more than two inlet channels are provided, a corresponding number of valves is preferably provided.
The at least one valve can either be an integral part of the dispense interface. Alternatively the at least one valve can also be designed as a separate part and then assembled with the body and/or the separate member. Possible valves are for example a diaphragm or flap valve, a shuttle valve, a molded duck bill valve, a flat spring, or rotation flap valve.
The technical problem is further solved by a system comprising a dispense interface according to the invention and an ejection device, wherein the dispense interface is attachable to the ejection device. For instance, the user can attach the dispense interface by a first double ended needle assembly to the ejection device. For this, connection elements of the respective components are adapted to each other. In particular, a fluid connection between two inlet channels of a preferably unused channel structure and at least one reservoir of the ejection device can be established. For instance, the user can rotate a body in the form of a drum until two unused inlet openings match the respective needles of the first double ended needle assembly.
As a consequence, the dispense interface can be used for a plurality of ejections, wherein the number of ejections may correspond to the number of channel structures. After all channel structures have been used, the dispense interface can be discarded.
The technical problem is further solved by a method for using a previously described dispense interface comprising the steps of attaching a first double ended needle assembly to the inlet openings of one channel structure of the dispense interface and attaching the dispense interface to an ejection device having at least two reservoirs such that a fluid tight connection is established between the at least two reservoirs and the channel structure of the dispense interface.
If a first double ended needle assembly is not an integral part of the body, a respective double ended needle assembly can be attached to each of the inlet openings of an unused channel structure of the dispense interface. If the double ended needle assembly is part of a first part of the body, the respective double ended needle assembly can be attached to the inlet openings of an unused channel structure of the second part of the body of the dispense interface.
When the user attaches the dispense interface to the ejection device, preferably the first needle of the double ended needle assembly provides a fluid tight connection to the first reservoir of the ejection device, for example by piercing a septum of the first reservoir, while the second needle of the double ended needle assembly provides a fluid tight connection to the second reservoir of the ejection device, for example by piercing a septum of the second reservoir.
In case the needle tips of the first double ended needle assembly are covered with needle covers, the user needs to remove these covers before attaching the dispense interface to the ejection device. In case the needle tip of the second needle assembly is covered with a needle cover, the user needs to remove this cover before performing an ejection procedure.
These steps are performed after having attached the dispense interface to the ejection device. When another ejection should be performed, a user can choose an unused channel structure of the body, for instance, by rotating the body. After all channel structures have been used, the dispense interface can be discarded. When a used channel structure of the dispense interface is removed after an ejection procedure, for example by the user, the risk of possible contaminations of the fluids and/or the reservoirs is reduced.
FIG. 12 illustrates an exploded view of a dispense interface according to the invention;
FIG. 13 illustrates a perspective view of the dispense interface illustrated in FIG. 12;
FIG. 14 illustrates a cross-sectional view of a further dispense interface according to the invention;
FIG. 15 illustrates valve elements, which can be used in a dispense interface according to the invention; and
FIG. 16 illustrates a flowchart of a method for using a dispense interface according to the invention.
The main body 14 contains a micro-processor control unit, an electro-mechanical drive train, and at least two medicament reservoirs. When the end cap or cover 18 is removed from the device 10 (as illustrated in FIG. 1), a dispense interface 200 is mounted to the distal end 15 of the main body 14, and a dose dispenser (e.g., a needle assembly) can be attached to the interface. The drug delivery device 10 can be used to administer a computed dose of a second medicament (secondary drug compound) and a variable dose of a first medicament (primary drug compound) through a single needle assembly, such as a double ended needle assembly.
Referring now to FIGS. 4 to 11, one preferred arrangement of this interface 200 will now be discussed. In this one preferred arrangement, this interface 200 comprises: a. a main outer body 210, b. an first inner body 220, c. a second inner body 230, d. a first piercing needle 240, e. a second piercing needle 250, f. a valve seal 260, and g. a septum 270.
FIG. 12 illustrates an exploded view of a dispense interface 500 according to the invention. In the present example, the dispense interface 500 comprises a body 502. The body 502 is of a cylindrical shape. In particular, the body 502 is a drum 502. For instance, the body 502 can be formed by molding, in particular by injection molding.
The body 502 comprises multiple channel structures wherein in the present example only a first channel structure 504 and a second channel structure 506 are provided with reference signs for sake of clarity. The first channel structure 504 comprises a first inlet channel 508 and a second inlet channel 510. Each of the inlet channels 508, 510 comprises an inlet opening 516, 518. The inlet openings 516, 518 are arranged at an edge region of the body 502. Thereby, the inlet openings 516, 518 of the first channel structure 504 may be arranged on a straight line 530 which passes the center 528 of the proximal end surface 552 of the body 502.
An inlet channel 508, 510 may comprise a first channel part which is substantially linear and runs parallel with the axis of the body 502 and a second part following the first part, wherein the second part is substantially linear and runs parallel to the distal end surface of the body 502. The second part of the inlet channel is an open recess 524. A channel can be established by connecting a separate member 532 at the distal end 554 of the drum 502, as will be explained hereinafter.
The second channel structure 506 comprises a first inlet channel 512 comprising a first inlet opening 520 and a second inlet channel 514 comprising a second inlet opening 522. Preferably, all channel structures 504, 506 in the body 502 are similarly formed.
Furthermore, a connecting channel 534 and an outlet opening 536 are provided. In the present example, the connecting channel 534 and the outlet opening 536 are provided by a separate component 532 which can be tightly connected to the body 502. Thereby, the connecting channel 534 is configured for a fluid communication between the two inlet channels 508, 510, 512, 514 of (only) one channel structure 504, 506. In particular, only one channel structure 504, 506 can be in fluid communication with the outlet opening 536 at the same time.
Furthermore, a first double-ended needle assembly 544 comprising a first double ended needle 548 and a second double ended needle 550 is provided. The first double-ended needle assembly 544 can be tightly connected with the body 502, in particular, with a first inlet opening 516, 520 and a second inlet opening 518, 522 of one channel structure 504, 506. In particular, only one channel structure 504, 506 can be in fluid communication with the first double ended needle 548 and the second double ended needle 550 at the same time.
A second needle assembly 542 comprising an ejection needle 546 is provided. The second needle assembly 542 can be an integral part of the separate component 532 or a further separate part which can be tightly connected to the outlet opening 536 of the separate component 532.
FIG. 13 illustrates a perspective view of the dispense interface 500 illustrated in FIG. 12. In FIG. 13, the first double ended needle assembly 544 is tightly connected to the body 502. In particular, the first double ended needle assembly 544 is tightly connected to the first channel structure 504. Furthermore, the separate component 532 is also tightly connected with the body 502. In particular, the separate component 532 is tightly connected to the first channel structure 504.
The illustrated dispense interface 500 can be attached to an ejection device, for instance manually by a user. After operating the ejection device, for instance, after ejecting at least one fluid from at least one reservoir of the ejection device, the dispense interface 500 can be removed from the ejection device. In addition, the separate component 532 and the first needle assembly 544 can be removed from the body 502. If the separate component 532 and the first double ended 544 needle assembly are single-use items, the respective components 532, 544 can be discarded.
If a further ejection should be performed, preferably a new separate component 532 and a new first double ended needle assembly 544 can be tightly attached to the body 502. In particular, the separate component 532 and the first double ended needle assembly 544 can be attached to an unused channel structure, like the second channel structure 506. Preferably, each channel structure of the body 502 is used for only ejection procedure. In the present example, since six channel structures are provided, the body 502 or drum 502 can be used six times. It shall be understood that according to other variants of the invention, there may be provided more or less channel structures.
FIG. 14 illustrates a cross-sectional view of a further embodiment of a dispense interface 600 according to the invention. The dispense interface 600 comprises a body 602 having a first part 604 and a second part 606. The first part 604 has at least partly a cylindrical shape. The second part 606 is rotatably mounted to the first part 604.
Furthermore, the first part 604 comprises a first double-ended needle assembly 626 with a first double ended needle 628 and a second double ended needle 630. The first double-ended needle assembly 626 is an integral part of the first part 604. It forms the proximal end 650 of the first part 604.
At the distal end 652 of the first part 604, a stop element 632 is arranged. As can be seen from FIG. 13, an elastic element 634, in particular, a spring 634 is provided between the stop element 632 and the second part 606. The elastic element is configured to exert a force onto the second part 606 in the proximal direction 636. This causes that the second part 606 is pushed against the first double-ended needle assembly 626.
The second part 606 may be a rotationally symmetric part having a plurality of channel structures. In the present FIG. 14, a first channel structure 608 comprising a first inlet channel 610 and a second inlet channel 612 is illustrated. The further (not shown) channel structures may comprise the same shape as the first channel structure 608. Each inlet channel 610 612 comprises an inlet opening 614, 616. The first and the second inlet openings 614, 616 are sealed with a pierceable layer 618, 620. Preferably, all inlet openings are sealed by a pierceable layer. For instance, a rubber seal or film is provided. For instance, the layer 618, 620 may be made of metal, polymer and/or biopolymer. The layer 618, 620 can be attached to the proximal end surface of the second part 606 by any suitable process, like bonding techniques or thermal bonding techniques, such as fusion, laser techniques.
As can be further seen, the first part 604 comprises a connecting channel 622. The connecting channel 622 is configured for a fluid communication between the two inlet channels 610, 612 and an outlet opening 624 of the first part 604.
Furthermore, s second needle assembly 642 comprising a needle 644 is provided. In the present example, the second needle assembly 642 comprises a connecting element 648 which corresponds to a connecting element 646 of the first part 604. The first part 604 comprises an external thread 646 for providing a positive fit with the needle assembly 642 to provide a threaded engagement.
The illustrated dispense interface 600 can be attached, for instance manually by a user, to an ejection device for an ejecting process. Preferably, each channel structure is used for only ejection procedure. For attaching a new channel structure to the first double-ended needle assembly 626, the second part 606 can be pushed forward, preferably by a user, in a distal direction 638. Thereby, a force must be exerted which is larger than the force exerted by the elastic element 634. In case a spring 634 is employed, the force to be exerted depends at least on the spring constant.
When the second part 606 is pushed forward such that the double-ended needles 628, 630 are fully exposed, the second part 606 can be rotated. When a first and second opening of an unused channel structures is arranged opposite to the first and second double-ended needle 628, 630, a user can release the second part 606 and due to the force of the elastic element 634, the double-ended needles 628, 630 automatically puncture the sealing layer of the respective inlet openings. After a second needle assembly is attached to the dispense interface 600, the ejection device can be operated and at least one fluid of at least one reservoir can be ejected.
It shall be understood that a new channel structure can also be attached to the double-ended needle assembly 626 after the attachment to the ejecting device.
FIG. 15 shows embodiments of a valve arrangement in particular for a previously described dispense interface 500, 600.
The valve arrangements may for instance be integrally formed with another part of the dispense interface. Alternatively, the valve arrangement may for instance be manufactured separately from the other parts of dispense interface.
For instance, the valve arrangement may be inserted (e.g. potted/over-molded) into the body portion. For instance, the valve arrangement may at least partially be inserted (e.g. potted/over-molded) when the body portion are injection molded. For instance, the valve arrangement may at least partially be inserted (e.g. mounted) in a separate step after the body portion have been injection molded.
FIG. 15a illustrates a diaphragm/flap valve arrangement 3000a. The diaphragm/flap valve arrangement 3000a has an inlet 3010 and an outlet 3030. The inlet 3010 may for instance reside in fluid communication with one of the piercing needles 240, 250 of dispense interface 200 or with one of the piercing needles 548, 550 of dispense interface 500 or with one of the piercing needles 628, 630 of dispense interface 600, and the outlet 3030 may for instance reside in fluid communication with holding chamber 280 of dispense interface 200 or with the ejection needle 546 of dispense interface 500 or with the ejection needle 644 of dispense interface 600.
The diaphragm/flap valve arrangement 3000a has flexible diaphragm/flap 3040. When the fluidic pressure in the inlet 3010 is increased (e.g. during a dose priming or a dose injecting step), the diaphragm/flap 3040 will change from an un-stressed state to a stressed state. In the stressed state, the fluidic pressure bends the diaphragm/flap 3040 as indicated by the arrow in FIG. 15a so that the diaphragm/flap valve arrangement 3000a opens. In this stressed condition, the diaphragm/flap valve arrangement 3000a will allow fluid to flow from the inlet 3010 to the outlet 3030. When the fluidic pressure in the inlet is removed, the diaphragm/flap 3040 will return to its initial position and seal the inlet 3010, preventing backflow.
FIG. 15b illustrates a shuttling valve arrangement 3000b. The shuttling valve arrangement 3000b has a tube 3050. The tube 3050 has two inlets 3010, 3020 and an outlet 3030. In the tube 3050 a movable element 3060 (e.g. a piston or a ball) is arranged.
The diameter of the movable element 3060 corresponds to the diameter of the tube 3050 such that the movable element 3060 is movable between a first and a second (longitudinal) position in the tube 3050. In the first position (illustrated in FIG. 15b), the movable element 3060 seals the inlet 3010 and allows fluid flow from the inlet 3020 to the outlet 3030. In the second position (not illustrated), the movable element 3060 seals the inlet 3020 and allows fluid flow from the inlet 3010 to the outlet 3030. When the fluidic pressure in the inlet 3010 is for instance increased (e.g. during a dose priming or a dose injecting step), the movable element 3060 will be pushed towards the second position as indicated by the arrow in FIG. 15b.
FIG. 15c illustrates a moulded duckbill valve arrangement 3000c. The moulded duckbill valve arrangement 3000c has a first and a second duckbill valve 3080, 3090. When the fluidic pressure in the inlet 3020 is increased (e.g. during a dose priming or a dose injecting step), the second duckbill valve 3090 will change from an un-stressed state to a stressed state. In the stressed state, the fluidic pressure inverts the naturally flattened shape of the duckbill valve as indicated in FIG. 15c so that the duckbill valve opens. In this stressed condition, the second duckbill valve 3090 will allow fluid to flow from the inlet 3020 to the outlet 3030. When the fluidic pressure in the inlet 3020 is removed, the second duckbill valve 3090 will return to its flattened shape and seal the inlet 3020, preventing backflow. The first duckbill valve 3080 operates in a similar manner as the second duckbill valve 3090 when the fluidic pressure is increased in the inlet 3010.
FIG. 15d illustrates a flat spring valve arrangement 3000d. The flat spring valve arrangement 3000d has a first and a second flat spring 3100, 3110. The first and the second flat spring 3100, 3110 may for instance be integrally formed.
When the fluidic pressure in the inlet 3010 is increased (e.g. during a dose priming or a dose injecting step), the first flat spring 3100 will change from an un-stressed state to a stressed state. In the stressed state, the fluidic pressure bends the first flat spring 3100 as indicated by the arrow in FIG. 15a so that the flat spring valve arrangement 3000d opens. In this stressed condition, the flat spring valve arrangement 3000d will allow fluid to flow from the inlet 3010 to the outlet 3030. When the fluidic pressure in the inlet is removed, the first flat spring 3100 will return to its initial position and seal the inlet 3010, preventing backflow. The second flat spring 3110 operates in a similar manner as the first flat spring 3100 when the fluidic pressure is increased in the inlet 3020.
FIG. 15e illustrates a rotating flap valve arrangement 3000e. The rotating flap valve arrangement 3000e has a flap 3120 which is rotatably mounted in a valve chamber 3130. The valve chamber has two inlets 3010, 3020 and an outlet 3030.
The flap 3120 is rotatable between a first and a second position. In the first position (illustrated in FIG. 15e), the flap 3120 seals the inlet 3010 and allows fluid flow from the inlet 3020 to the outlet 3030. In the second position (not illustrated), the flap 3120 seals the inlet 3020 and allows fluid flow from the inlet 3010 to the outlet 3030.
When the fluidic pressure in the inlet 3010 is for instance increased (e.g. during a dose priming or a dose injecting step), the flap 3120 will be pushed towards the second position as indicated by the arrow in FIG. 15e.
FIG. 16 illustrates a flowchart of a method for using a previously described dispense interface. In a first step 701, a first double ended needle assembly may be attached to the dispense interface. Preferable, the user attaches the first needle and the second needle to a first inlet opening and a second inlet opening, respectively, of an unused channel structure of the dispense interface. For selecting an unused channel structure, it may be required to rotate the body or a second part of the body of the dispense interface, as described hereinbefore. The user can recognise unused inlet openings e.g. by examining a provided seal layer.
It shall be understood that if a totally unused dispense interface is used, it may be necessary that in a previous step, a packaging must be removed by the user.
When the first double ended needle assembly is attached to the dispense interface, in an optional step, it may be necessary to attach a separate component to the body of the dispense interface. The separate component may already comprise a second needle assembly comprising an ejection needle. The separate component may be configured for establishing a fluid communication from the inlet channels of one channel structure via a connecting channel to an outlet opening of the dispense interface. In other variants of the invention, only the second needle assembly must be attached. For instance, a first part of the body, in particular, the outlet opening of the first part may comprise means for attaching a second needle assembly.
Then, in step 702, the dispense interface can be attached to the ejection device by the user. The needles of the first double-ended needle assembly provide the piercing needles for the first and the second reservoirs. This establishes a fluid tight connection between the primary fluid from the first reservoir with the outlet opening of the dispense device. Simultaneously, this establishes a fluid tight connection between the secondary fluid from the second reservoir with the outlet opening of the dispense device.
The user can then start an ejection procedure with the device in step 703.
After the ejection procedure, the user can remove the dispense interface from the ejection device (step 704).
If all channel structures have been used, the respective dispense interface can be discarded. Otherwise, the user can for instance put the dispense interface in a suitable storage box or the like. When a next ejection is required, the user can take the dispense interface from the storage box and can start the preparation of the dispense interface according to step 701. In particular, an unused channel structure can be attached by the user to a first double ended needle assembly.
Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-V- al-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly -Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
TABLE-US-00001 H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2, des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin- 4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4 (1-39); or des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin- 4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin- 4(1-39),
TABLE-US-00002 H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)- (Lys)6-NH2, H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)- (Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin- 4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)- (Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin- 4(1-39)-(Lys)6-NH2;
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