CN1870960B - Reservoir device with integral mounting means - Google Patents

Abstract

The present invention provides an apparatus comprising a housing and a flexible reservoir adapted to contain a fluid and having a septum member formed from a needle-penetratable self-sealing material. The flexible reservoir is arranged within the housing in combination with mounting means arranged within or formed by the housing, wherein the mounting means engages the septum member to thereby mount the flexible reservoir relative to the housing. In this way a secure fixation between the reservoir and the housing is provided without having to interfere with the general flexibility of the reservoir, e.g. substantially the entire flexible reservoir apart from the outlet/mounting means may be arranged free to move relative to the housing, this allowing the reservoir to be emptied to a high degree.

Description

Reservoir device with integral mounting means

technical field

The present invention generally relates to a device comprising a reservoir for storing a fluid. The reservoir can be used to contain, inter alia, medical fluid substances such as medicines, medical fluids, infusions, injections, dialysis fluids, perfusion fluids, chemical and nutritional fluids, human blood and components thereof, and the like. Such a reservoir can also be used for other purposes, for example for storing calibration fluids for analytical equipment.

Background technique

In the disclosure of the present invention, the above-listed liquids in the form of medical liquids are mainly directed, however, this is only an exemplary application of the present invention.

Medical liquids are usually contained in a reservoir (such as a container, bag or bottle) which is accessible by means of a hollow needle which usually penetrates a dedicated connection element (or access device) of the reservoir so as to communicate with the reservoir. fluid communication within the device. Needle access can be used both to withdraw fluid from the reservoir and to supply fluid to the reservoir. For example, when preparing a fluid that is to be administered to a patient from a given reservoir, it is common to supply the active drug into a pre-sealed reservoir filled with the delivery fluid, said The delivery fluid is usually sodium chloride solution or dextrose solution, and then the diluted drug is given to the patient through an intravenous (IV) infusion set. For such applications, the reservoir may be provided with a single connecting element adapted for both purposes, or the reservoir may comprise two connecting elements, each serving a respective purpose, e.g. Larger input device outlet needle and smaller drug injection needle. The connecting element can be opened by hand to provide an opening into which a needle can subsequently be inserted, or a pointed needle can be used to penetrate the connecting element, and the connecting element can be self-sealing, for example, after the needle has been withdrawn , the connecting element will seal the reservoir.

If the reservoir is made of glass, then the connecting element can be a separate element which is fitted to said glass reservoir by dedicated means, however, for plastic reservoirs the connecting element is usually formed with the reservoir A whole. One of the most widely used medical plastic reservoirs is the flexible infusion bag with one or more needle-penetrable connecting elements in the lower part. Such bags are usually made of flexible foils which are joined to form the interior space. Depending on the actual configuration of the pouch, the connection elements may be arranged on a surface portion of the foil, or may be arranged corresponding to an edge portion of the reservoir. For the latter type, a connecting element is usually arranged and fixed in position between two foils connected to each other by welding.

For both of the above constructions, the self-sealing element is usually carried by a tubular element which is attached to the bag in either of the above two ways. For example, US Pat. No. 4,362,458 discloses an infusion bag, wherein a tubular nozzle element is connected to the infusion bag corresponding to a free surface of the infusion bag, and a self-sealing rubber element is mounted on the nozzle.

For certain liquids, such as certain types of drugs, it is desirable that the elastomeric material normally used to make the sealing element does not come into contact with the drug. To solve this problem, European Patent Application EP0364783 discloses a vial having an outer sealing element held in place by a separate cap element which is attached to the outer surface of the vial. On the surface, and in FR2752410, a medical bag is disclosed, wherein a needle-penetrable element is attached to the outer surface of the medical bag.

US Pat. No. 6,074,369 discloses an injection device comprising a flexible reservoir consisting of two Belleville elastic membranes between which a needle-penetrable element is arranged. The reservoir is mounted within a housing by means of mounting means engaging the diaphragms.

The above-mentioned reservoirs are quite large, typically containing 100-1000ml of liquid, however, reservoirs accessible through a penetrating needle also use much smaller volumes. For example, certain calibration solutions used for calibrating analytical devices are contained in sachet-type reservoirs that contain only a few milliliters. With the right design, these small reservoirs could also be used for pharmaceutical purposes.

Contents of the invention

In view of the aforementioned reservoir and device, it is an object of the present invention to provide a device comprising a liquid reservoir which can be manufactured and used in an efficient manner. Another object of the present invention is to provide a device that is easy and safe to use and suitable for various purposes. Another object of the present invention is to provide such a reservoir which can be used for various liquids. Other objects and advantages of the present invention will be more clearly understood through the disclosure of the present invention together with the description of the exemplary embodiments.

In the disclosure of the present invention, some embodiments and some aspects of the present invention will be described, and these embodiments and these aspects can achieve one or more of the above objects, or these embodiments and these aspects can realize those from Purposes are apparent from the following disclosure and from the description of exemplary embodiments.

More specifically, in a first aspect of the invention there is provided a device comprising a housing, comprising: mounting means (for example disposed within or formed by the housing); a flexible reservoir, the flexible reservoir adapted to contain fluid; and comprising a septum element made of a needle-penetrable flexible material (eg, an elastomeric material), at least a portion of the flexible reservoir being disposed within the housing, wherein the mounting means engages the septum element, The flexible reservoir is thereby mounted relative to the mounting means. In this way, a firm fixation is provided between the reservoir and the mounting means without interfering with the overall flexibility of the reservoir, e.g. substantially the entire flexible reservoir, except for the outlet/mounting means, can be arranged relative to The mounting means can move freely, which allows the reservoir to be emptied to a high degree. Usually, the housing is closed such that the reservoir is arranged within the housing, however, in principle the housing may be open, in which case the housing acts as a supporting structure, in the context of the present invention the term The housing includes support members. The mounting means may be fixed relative to the housing, or may be movable relative to the housing, eg the mounting means may be slidable relative to the housing, which allows the reservoir to be moved into engagement with other components such as a pump assembly.

In an exemplary embodiment, the membrane is self-sealing. Although the term "self-sealing" will be clear to those skilled in the art, it should be noted that it cannot be considered an absolute term for a given membrane, as it depends on the use of the given reservoir. For example, a given septum is configured to be self-sealing, connects to needles of a given range of gauges (ie diameters), and has a given profile design for the pointed tip. Thus, a relatively thin septum suitable for a correspondingly thin needle may not self-sealing when pierced by a larger needle. Furthermore, the punctured septum may leak if the reservoir is pressed above a predetermined internal pressure.

The term "suitable for containing" is defined as that the reservoir of the present invention may be provided in an empty state for subsequent filling, or the reservoir may be filled during manufacture to provide a pre-filled storage.

The reservoir may comprise first and second flexible foil parts that are sealed together (e.g., provided by separate foil elements or a single folded foil element) so as to form a closed chamber for containing fluid, such The reservoir has a bag-like structure.

If the fluid (liquid or gas) contained in the reservoir places no specific performance requirements on the surrounding walls (e.g. in terms of evaporation, leakage or chemical inertness), then the first wall part may be made of a single layer of material, or Yes, the reservoir is generally made of a single material. If the fluid requires specific properties from the reservoir, the reservoir may be provided with an outer surface generally made of a first material and an inner surface generally made of a second material. The portion of the wall providing the first mounting surface may have a particular configuration (eg, to allow needle penetration) and the remainder of the reservoir wall have different properties.

The reservoir may comprise at least first and second flexible foil (or membrane) elements sealed together so as to form at least one closed chamber for containing liquid. A foil element may be two or more separate elements, or may be a single element folded upon itself. The foil element may be a composite laminate of successive layers comprising an outer layer and an inner layer. This allows the outer surface to be optimized for connection with the diaphragm element and the inner surface can be optimized in terms of reservoir performance for the fluid contained. Any laminate mentioned in the present invention may be a conventional laminate, a coextrusion or an extrusion laminate. The walls making up the reservoir may be made of a single material or a single type of laminate, or different materials or laminates may be used for different wall portions of the reservoir.

The foil elements may comprise an intermediate layer, the inner layer being made of a weldable material which allows the foil elements to be at least partially sealed together by welding the peripheries of the corresponding bags. If the outer layer only provides the mounting surface for the membrane, then the "middle" layer may provide the outer layer for a portion of the reservoir. In order to allow the contained liquid to be seen through the reservoir wall, at least a portion of the reservoir wall may be made of a transparent or translucent material.

Just as a portion of the outer reservoir wall can be optimized to attach the diaphragm by welding, so can the diaphragm mounting surface. For example, the membrane may be a laminate comprising two or more layers, the "lower" layer providing the mounting surface. The diaphragm may be welded to the reservoir corresponding to substantially the entire mounting surface, however, the diaphragm may also be welded with one or more (concentric) peripheral welds.

In addition to sealing properties, diaphragms can also be configured to provide additional properties. For example, a portion of the diaphragm or the entire diaphragm may be configured to bend with the portion of the reservoir to which it is mounted, which allows the diaphragm to be bent during manufacture as well as during use. To allow for such bending, the diaphragm may be in the form of a relatively thin element, or it may comprise relatively thin sections. Furthermore, when the diaphragm is placed "naked" on the reservoir, it can be accessed over a wide range of angles.

In an exemplary embodiment, the device further comprises a fluid conduit having an inlet and an outlet, the inlet being adapted to be placed in fluid communication with the reservoir outlet device, wherein from an initial position and a connected position , the fluid conduit and the reservoir are movable relative to each other. In the initial position, there is no fluid communication between the inlet of the fluid conduit and the reservoir. In the connected position, the inlet of the fluid conduit is in fluid communication with the reservoir through the reservoir outlet device. The fluid conduit may be in the form of (or include) a pointed needle.

In an exemplary embodiment, the device further includes an expulsion assembly adapted to expel fluid (eg, drug) contained in the reservoir through an outlet of the reservoir. The expulsion assembly can be used to actuate or draw drug from the reservoir. In the latter case, the expulsion assembly may be in the form of a suction pump having: an inlet; an outlet; Create fluid communication.

The reservoir and expulsion assembly can be configured to be relatively movable. If the reservoir is movable, this means that the mounting means are also movable relative to the expulsion assembly and the housing. Alternatively, both the reservoir and expulsion assembly may be fixed relative to each other, with fluid communication provided by a moveable fluid connection, advantageously provided as part of the expulsion assembly, so as to serve as an inlet. More specifically, in an initial state, a fluid connection may be provided inside the expulsion assembly, the fluid connection including an inlet and an outlet, wherein the fluid connection is configured to be operated from the initial state and into an operational state, in the operational state , a fluid connection is formed between the interior of the reservoir and the interior of the expulsion assembly through a fluid joint, and the outlet of the fluid joint is arranged in the flow path of the expulsion assembly.

Such a device may be in the form of a skin-mountable pump device, further comprising: a transdermal device adapted to penetrate the skin of the subject; a mounting surface adapted to be applied to the skin of the subject, wherein The reservoir contains a fluid medicament, and in use, the expulsion assembly is configured to expel said medicament from said reservoir and through the skin of a subject through the transdermal device. Transdermal devices can be in the form of pointed hollow infusion needles, microneedle sets, pointed needle sensors, or a combination of blunt cannulae that are themselves quite soft, or sensors with pointed needles can provide pointed transdermal devices , the pin can be retracted after being inserted into the blunt part of the transdermal device. Advantageously, the cannula is flexible and bendable relative to the pin, which is usually a stiff steel needle. In the disclosure of the present invention and the description of the exemplary embodiments, a transdermal device in the form of an infusion needle is primarily directed. The reservoir may be provided to the user in a pre-filled form, or may be filled (and refilled) by the user.

The present invention also provides a method of mounting a flexible reservoir comprising the steps of: providing a support structure including mounting means; providing a flexible reservoir comprising a needle penetrable self-sealing septum element engaging the diaphragm element and the mounting means so that the mounting means clamps or engages the diaphragm element to correctly fix and position the diaphragm element relative to the mounting means.

When the reservoir comprises first and second flexible foil parts that are sealed together so as to form a reservoir having a pouch-like configuration, this may be achieved by a reservoir having a welded area along the length of the reservoir. The peripheral part of the device and the folding part are set. The mounting means may engage the welded and/or folded peripheral portion to properly secure the reservoir in place with the mounter engaging the diaphragm element, or the securing of the reservoir may be done separately. For example, if the reservoir is sufficiently rigid, mounting means engaging the peripheral portion of the reservoir can correctly position the diaphragm element without engaging the diaphragm.

As noted above, a "bare" septum configuration may be adapted to allow needle insertion at an angle other than perpendicular. Accordingly, in another aspect of the invention there is provided a device comprising a flexible reservoir comprising first and second flexible foil portions sealed together so as to form a A closed chamber for fluid, the reservoir has a pouch-like configuration defining a general plane, the needle-penetrable outlet being provided on a portion of the reservoir inclined relative to said general plane. In fact, the outlet will have to be adapted to provide a seal around the needle in order to avoid leakage of any substance. The device also includes a needle having a generally straight inlet portion and an outlet, the inlet being adapted to be placed in fluid communication with the reservoir, wherein the needle and reservoir are configured to move from an initial position to a connected position Relatively movable, in an initial position, there is no fluid communication between the needle inlet and the reservoir, in the connected position, the needle inlet and the reservoir are in fluid communication through the outlet in the reservoir, wherein the needle in the connected position is substantially The reservoir is pierced parallel to the general plane.

The reservoir can be formed, for example, from two separate foil elements welded together at their periphery (for example at the four sides of a square reservoir), or by folding the foil over the remaining perimeter (for example at the four sides of a square reservoir). at three sides of the vessel) to form the reservoir, or, the foil tube is welded together at both ends to form the reservoir. Thus, for a typical bag or bladder shaped reservoir, welds (eg two opposed welds) can be used to define the general plane of the reservoir, however, welds may also be placed in other locations. When the reservoir is filled, the reservoir will typically expand providing one or more convex surfaces, the convex surfaces other than the "top" surface will be disposed at an inclination relative to the general plane. In order to provide a portion of the foil surface that is more sloped than the surface of the reservoir of the "native" configuration, a portion of the reservoir can be skewed relative to the rest of the reservoir, e.g., bent along a line, which facilitates needle insertion into in storage.

The outlet may be provided in any suitable configuration to allow the needle to be in fluid communication with the interior of the reservoir. If the foil material forming the reservoir allows the needle to penetrate in a leak-tight manner, no additional elements need be provided, however, in most cases additional outlet elements must be provided.

For example, the reservoir outlet element may be in the form of a septum element formed from a needle-penetrable self-sealing material as described above, advantageously the septum being joined by welding. The membrane may also cover parts of the reservoir other than those forming the outlet, for example, the membrane may be arranged on a circular edge portion of the reservoir so as to also cover the surface of the reservoir perpendicular to said general plane. part of the positioning. As noted above, the walls of the reservoir may comprise one or more layers, depending on the fluid contained within the reservoir.

In some preferred embodiments, said inclination angle is less than 45 degrees, preferably less than 30 degrees, more preferably less than 15 degrees (parallel is defined as zero degrees). By introducing the needle at an oblique angle, it is possible to completely or partially collapse the reservoir without the needle penetrating the part of the reservoir opposite the outlet element.

In an exemplary embodiment, the angled needle configuration described above may be combined with an expulsion assembly and a transdermal device to provide the delivery device described above.

As described above, there is provided a reservoir comprising a membrane in combination with additional means for mounting and/or connecting the reservoir. Accordingly, in accordance with a further aspect of the present invention, there is provided a reservoir itself adapted to contain a fluid in a chamber formed by walls, the reservoir comprising a first wall portion, the first wall portion Made of a needle-penetrable material, wherein the wall portion includes an outer first mounting surface. This reservoir also comprises a septum element (hereinafter also referred to as a septum) made of a needle-penetrable self-sealing material, the septum element comprising a second mounting surface, wherein, corresponding to the second mounting surface, The diaphragm element is mounted on the first mounting surface by welding the two surfaces together. The arrangement of the material of the first mounting surface corresponds only to the seating of the diaphragm, or alternatively, the material of the first mounting surface may cover the entire outer surface or a part of the outer surface of the reservoir. Such a reservoir can be a relatively rigid reservoir, such as a blown bottle, or a more flexible reservoir, such as a conventional intravenous (IV) access bag as described above.

Although the septum can be mounted separately, it is desirable to provide additional mounting means so that access means such as tubing can be connected to a reservoir such as the known IV bag described above . For example, a tubular connector protruding from the surface of the reservoir may be attached around the septum, eg, peripherally. In this way, the two parts can be connected independently of each other without the need to mount the diaphragm to the joint, but in a convenient manner, during the welding process, to connect the two parts to the reservoir at the same time superior.

Diaphragms can also be fabricated for other purposes. For example, if the reservoir is in the form of a flexible reservoir which is adapted to be installed in the drug delivery device described above, then, during the installation procedure, just as the septum can be used as a barrier between the reservoir and the delivery device. Like the connecting device, the membrane can be used to handle the reservoir, for example, the membrane element can be welded to the delivery device, or the membrane element and delivery device can be provided with cooperating adapters.

The membrane and reservoir forming materials according to the different aspects of the invention may be selected according to the above-described embodiments and their use. For example, the wall portion providing the first mounting surface may be made of or comprise the following materials: polyethylene (PE), polypropylene (PP), oriented polypropylene (OPP), amorphous polyester (PET), Oriented amorphous polyester (OPET), polyamide (PA) or oriented polyamide (OPA). The part of the membrane forming the second mounting surface may be made of a thermoplastic elastic (TPE) material, for example an oleophilic based thermoplastic material or an oleophilic based thermoplastic vulcanizate or a mixture thereof. More particularly, the TPE may be a thermoplastic vulcanizate consisting of bromo-butyl rubber in a polypropylene matrix (such as that marketed under the registered trademark Trefsin), a thermoplastic vulcanizate made of EPDM in a polypropylene matrix. Thermoplastic vulcanizates of rubber (such as those sold under the registered trademark Santoprene) or elastomers based on styrene-butadiene-butylene (SEBS) copolymers (such as those sold under the registered trademark Kraiburg elastomer). In addition, TPU, TPE-A or TPE-E can also be used.

As used herein, the term "drug" includes any flowable drug containing drug, such as a liquid, solution, gel or fine suspension, which can be delivered in a controlled manner through a delivery device such as a hollow needle. Representative drugs include agents such as peptides, proteins, hormones, biologically derived or active agents, hormone and gene based agents, nutritional formulas and other substances in solid (dispensed) or liquid form. In the description of the exemplary embodiments of the present invention, the use of insulin is mainly described. Thus, the term "subcutaneous" infusion includes any method of subcutaneous delivery to a subject.

Here, the term "insulin" refers to insulin from any species, such as porcine insulin, bovine insulin and human insulin, its salts such as zinc salts, protamine salts and active derivatives of insulin and insulin analogs. The term "active derivatives of insulin" is generally considered by those skilled in the art to be derivatives referred to in general textbooks, for example, insulin with a substitute not present in the parent insulin molecule. The term "insulin analogue" means an insulin in which one or more amino acid residues have been exchanged for another amino acid residue, and/or from which one or more amino acid residues bases have been deleted, and/or from such insulin, one or more amino acid residues have been provisoed such that the insulin analog has sufficient insulin activity.

The materials used to form the reservoir or reservoir device of the present invention can be selected according to the application. Therefore, these materials can be required to meet specific functional requirements such as physical property requirements of materials after sterilization, chemical requirements of materials after sterilization, and cleanliness requirements. Thus, materials can be sterilized using gamma rays, electron beams, steam or ethylene oxide. The material can also be selected according to one or more of the following requirements, these requirements are: 1) the material must be transparent, 2) the material must have good resistance to water evaporation; 3) the material must have good resistance to gas ( such as oxygen and carbon dioxide); 4) the material must have good resistance to preservatives (such as phenol and partial cresol (meta-cresol)); 5) the material must have good resistance to odors (such as preservatives); 6) the material must be resistant to Resistance to environmental stress cracking (e.g., oil, spices); 7) material must be resistant to bending cracking; 8) material must have good sealing properties (e.g., by welding); 9) material must be resistant to cracking during handling or storage The period must not delaminate after sterilization, 10) the material must not relax significantly during storage and use, 11) the material must not release substances to the drug that have an impact on the health and safety of the patient (leachable);12 ) the material must have very low levels of extractables; 13) the material must be compatible with the formulated drug contained. It is also relevant that the material fulfills certain health and safety requirements, preferably most or all of the requirements mentioned in the following document regulations: 1) European Pharmacopoeia (PH.Eur) 2002 No. 4th edition; 2) United States Pharmacopoeia (USP) 25; 3) Japanese Pharmacopoeia (JP) XIV; 4) EEC regulation 90/128 + revision "on plastic materials and articles used in contact with food"; 5) Federal regulations (CFR ), 21 Title Food and Drugs, Parts 170-190; 6) III/9090/90EN. Plastic primary packaging material. Guidance note; 7) Industry guide. Container Closure Systems, Chemistry, Manufacturing, and Controls Documentation for Packaging Human Drugs and Biologics. FDA, May 1999.

With regard to laminates, the following definition applies: Coextrusion includes a process in which two or more polymeric materials are combined in two or more extruders and passed through a flat die or nozzle The system is coextruded and then cooled to form a coextruded foil. Extrusion lamination includes a process in which one or more layers of molten material are applied from one or more extruders to a feedstock in the form of a foil material through flat nozzles or systems of flat nozzles and then cooled to Extruded laminated foils are formed. "Conventional" lamination involves a process in which two supply blanks of foil material are joined together by adding a suitable adhesive to the foils, and then a second foil is added to form the laminated foil. A tie layer is a layer which is placed between two polymeric layers for the purpose of bonding in order to join said two layers together.

Description of drawings

Exemplary embodiments of the present invention will be further described below with reference to the accompanying drawings, in which,

Figure 1 is a perspective view of a drug delivery device,

Figure 2 is a perspective view of another drug delivery device,

Figures 3 and 4 show a pump unit and reservoir connection,

Figure 5A is a general schematic diagram of a pump connected to a reservoir,

Figure 5B is an exploded view of the pump assembly,

Figure 5C is a cross-sectional view of the pump assembly in Figure 5B,

5D and 5E are partial cross-sectional views of the pump assembly in FIG. 5C,

Figure 6A is a perspective view of a flexible reservoir,

Figure 6B is a side view of the reservoir in Figure 6A,

Figure 6C is a top view of the reservoir in Figure 6A,

Figure 7A is a side view of a reservoir with needles inserted,

Figure 7B is a perspective view of the reservoir in Figure 7A viewed from above,

Figure 7C is a perspective view of the reservoir in Figure 7A viewed from below,

Figure 8 is an exploded view of another reservoir unit.

In these figures, the same components are mainly denoted by the same reference numerals.

Detailed ways

When the terms "upper" and "lower", "left" and "right", "horizontal" and "vertical" or similar relative terms are used below, these terms are for the drawings only and not for actual usage. spoken. The drawings are only schematic and for this reason the arrangement and relative dimensions of the different components are for explanatory purposes only.

In FIG. 1 , a drug delivery device is shown that includes a flexible reservoir that may embody one or more aspects of the present invention.

More specifically, FIG. 1 shows an exploded perspective view of a medical device in the form of a drug delivery device 200 comprising: a needle unit 210 having a needle housing 211; a base member 230 , the base element having a lower mounting surface suitable for application to the skin of a subject; a separate reservoir and pump unit 250 . In the illustrated embodiment, the base element comprises a relatively stiff upper part 231 which is connected to a softer adhesive sheet element 232 provided with grippable strips and having a lower adhesive surface, This lower adhesive surface provides the mounting surface itself. In the illustrated embodiment, the needle housing is attached to the base plate as a single unit, the two elements being combined to form the needle unit. A hollow infusion needle 212 is rotatably arranged in the housing.

The needle unit comprises first and second openings 213, 214 which may be opened or covered by a needle penetrable membrane to provide a sealed interior. The needle includes a proximal inlet end and a pointed distal outlet end. The housing also includes a driving device (not shown in the figure) and a retracting device (not shown in the figure), the driving device is used to move the needle between the retracted state and the extended state, and the retracting device Used to move the needle between an extended position and a retracted position. The driving means and the retracting means are driven by graspable first and second straps 221, 222, which are connected to corresponding means through slot-shaped openings in the housing, Fig. The slot 223 for the first strap in the housing can be seen in . The second strip is also connected to the sheet strip 233 . Provided on the housing are user actuatable male coupling means 240 in the form of a pair of resiliently disposed hook elements adapted to mate with female coupling means on the reservoir unit Cooperate. The housing also includes connection means 225 for establishing fluid communication between the pump unit and the reservoir (see below), and communication means 226 for activating and deactivating the expulsion means.

The reservoir unit 250 comprises a housing 251 in which the reservoir and expulsion means comprising a pump unit 270 and a control and drive means 280 are arranged. The reservoir 260 is in the form of a pre-filled flexible collapsible bag with a needle-penetrable septum 261 welded thereto, adapted to be placed in fluid communication with the pump unit through the pump inlet 272 . The reservoir is in the form of a flat bag substantially parallel to the general plane of the device, and the septum is mounted on an initially convex upper surface of the reservoir, thereby allowing the needle to be substantially parallel to the upper wall of the reservoir and The lower wall pierces the septum. The housing includes mounting means (not shown) which secure the diaphragm relative thereto and a window 252 which allows the user to inspect the contents of the reservoir. The pump shown is a mechanically driven membrane pump, however, the expulsion means may be of any suitable construction.

The control and driving device can be arranged on a PCB or a flex-print, and the control and driving device includes: a pump driving element 281, which is a lever and piston structure, driven by a coil driver 282; Processor 283, used to control pump driving, etc.; contact switch 284, which cooperates with the communication device 226 on the needle unit; signal generating device 285, used to generate auditory and/or tactile signals; energy source 286.

In Fig. 2, a drug delivery device having the same general structure as in Fig. 1 is shown. More specifically, FIG. 2 shows a drug delivery device 500 comprising a needle unit 510 having a housing portion 511 and a relatively rigid base portion 530 connected to a softer adhesive. On the sheet element 532, the adhesive sheet element has a lower adhesive surface for providing the mounting surface itself. A needle drive unit 509 is provided inside the housing, and the needle drive unit includes a hollow infusion needle 512 arranged to be rotatable relative to the base plate.

The inlet portion of the needle is arranged corresponding to the axis of rotation, and the inlet portion is protected by a cylindrical member 513 so as to prevent the user from accidentally being stuck by the needle. In order to cooperate with the driving and retracting strips 521, 522, the needle driving unit 509 includes: driving means for moving the needles between retracted and extended states; Move the needle between the back positions. The needle unit also includes a male adapter 540 and a female adapter (not shown), which are adapted to cooperate with corresponding female and male adapters 555 on the reservoir unit and connection means 525, so that the pump unit and The reservoirs are in fluid communication (see below).

The reservoir unit 550 comprises a housing made up of an upper housing part 551 and a lower housing part 553 in which the reservoir and expulsion means comprising a pump unit 570 and a control means 580 are arranged. The lower housing portion includes two windows 552, 554 to allow the user to inspect the contents of the reservoir, corresponding to a reservoir indicator (see below). The reservoir 560 is in the form of a pre-filled flexible foldable bag formed by folding a flexible foil corresponding to one edge of the reservoir and sealing along the remaining three edges, corresponding to the circular folded edges, A needle-penetrable septum 561 is welded to the reservoir. The pump unit in the illustrated embodiment is in the form of a membrane pump comprising: a pump drive element in the form of a coil driver 582 and operatively connected thereto; a mounting device in the form of a The form of the slot 562 makes it possible to install and fix the diaphragm with respect to the inlet device of the pump.

The control device includes: a microprocessor 583 for controlling pump driving, etc.; a signal generating device 585 for generating auditory and/or tactile signals; and an energy source 586 . A reservoir indicator 582 is connected to the control unit for indicating to the user the amount of drug remaining in the reservoir. The indicator may be in the form of an electrochemical strip such as the type used in batteries.

Referring to Figures 3 and 4, another alternative construction of the reservoir mounting device is shown. The pump unit 670 comprises: a base plate 675, which has a first groove portion 676; a clamping element 677, which has a second groove portion 678, as shown in FIG. 4, when the clamping element is locked to the base plate When on, the two groove portions are adapted to engage opposite surfaces of the diaphragm member 661 of the reservoir 660 so that the diaphragm member is securely seated relative to the pump inlet device 672 . These slot portions may be provided with additional gripping means (such as protrusions, not shown) for preventing the diaphragm from sliding out of engagement with the mount. In the illustrated embodiment, the pump inlet device is in the form of a pointed hollow needle which protrudes from the pump unit prior to installation of the reservoir, however, advantageously, when the reservoir is installed just prior to use, the pump unit and reservoir There may be no fluid communication between them, which will be explained in more detail below. In the illustrated embodiment, the diaphragm is clamped between a part of the pump and a separate clamping element, however, it is also possible to form one or both of these members with housing parts such as upper and lower housing parts. A whole.

The pump unit also includes a coil driver 682 adapted to engage the piston elements 683, 340 of a diaphragm pump (see below). In the illustrated embodiment, the base plate 675 and clamping member 677 are separate components, however, they may be integrally formed with the upper and lower housing portions, respectively.

In FIG. 8, an exploded view of another reservoir unit is shown, comprising: an upper housing element 710; a lower housing element 720 having a transparent region 721; a flexible reservoir 760, the flexible The reservoir has a circular edge portion 762, on which the diaphragm element 761 is mounted; a pump assembly 770, which has a driver; a circuit board (not shown), which is arranged above the reservoir, and Includes some electronics for controlling the pump drive. The upper and lower housing elements include mounting means in the form of opposed upper and lower ridge portions 780 (lower not visible) adapted to engage and mount said reservoir in the housing. Each ridge portion includes a central cutout portion 781 for engaging the opposing surface of the diaphragm member when the housing member is assembled to lock the reservoir in place within the housing. The degree of locking is determined by the pressure exerted on the membrane element, the elasticity of the membrane element and the friction between the ridge and the membrane element. On each side of the cutout portion, the ridge portion includes a straight portion 782 that can facilitate mounting the reservoir in the housing. The straight portion may engage an initially pre-filled reservoir to help lock the reservoir in place, however, as the reservoir becomes empty and flattened, this clamping force may decrease. In contrast, this engagement with the septum is adapted to secure the reservoir properly in place when the reservoir becomes empty. The straight part can also be used to clamp the reservoir and flatten the reservoir completely, so that the straight part acts as an additional mounting means. Additional mounting means (not shown) may engage and clamp the reservoir at other locations, such as along weld edge 765 to engage and clamp the reservoir.

Referring to FIG. 5A, there is shown a general schematic view of a pump connected to a reservoir, the pump including the following general features: a fluid connection 391 for filling a reservoir 390; a safety valve 392; an inlet valve 393 and an outlet valve. valve 394; pump chamber 395 with associated piston 396; outlet 397. The arrows in the figure indicate the direction of flow between the various components. As the piston moves downwards (in the figure), a relative negative pressure will develop in the pump chamber which will cause the inlet valve to open and fluid to be drawn from the reservoir through the open first side of the relief valve. When the piston moves upwards (in the figure), a relative overpressure is formed in the pump chamber, which closes the inlet valve and opens the outlet valve and safety valve, so that the fluid passes from the pump chamber through the outlet valve and safety valve. The two sides flow to the outlet. As shown, during normal operation, the relief valve is "passive" by allowing fluid to pass therethrough during intake and expulsion of fluid. However, in the event that the reservoir is pressurized (as may happen with flexible reservoirs), the elevated pressure in the reservoir will be transferred through the pump chamber to the first side of the safety valve and also to the side of the safety valve. The second side, in which case the pressure on the first side of the relief valve will prevent the second side from opening.

In FIG. 5B, an exploded view of a pump assembly 300 utilizing the pumping principles described in FIG. 5A is shown. The pump assembly (hereinafter also referred to as the pump) is suitable for use with the reservoir in Figures 1-4. The pump is a membrane pump comprising a piston driven pump membrane with fluidically controlled inlet and outlet valves. The pump has a generally laminated structure comprising first, second and third elements 301, 302, 303 between which first and second membrane layers 311, 312 are sandwiched so that the first and The second element is combined with the first film layer to form a pump chamber 341, the first and third elements are combined with the first film layer to form a safety valve 345, and the second and third elements are combined with the second film layer to form an inlet valve 342 and outlet valve 343 (see Figure 5C). The layers are fixed by an external clip 310 into a stacked structure. The pump also comprises an inlet 321 and an outlet 322 and a connection opening 323, which are covered by corresponding membranes 331, 332, 333 which seal the interior of the pump in the initial sterile state. These membranes can be penetrated or punctured by needles or other elements introduced through a given seal (eg made of paper). The outlet also includes a self-sealing, needle-penetrable (eg, rubber-like material) septum 334 that allows the pump to be connected to the outlet needle. As shown in Figure 5C, through the first side of the safety valve 345, between the inlet 321 (see below) and the inlet valve 342, between the inlet valve, the pump chamber 345 and the outlet valve 343, through the second side of the safety valve Both sides form a fluid path (indicated by dark lines) between the outlet valve and the outlet 322, the fluid path being formed in or between different layers. The pump also includes a piston 340 for driving the pump membrane, the piston being driven by an external drive (not shown).

The pump also includes a fluid connection in the form of a hollow connection needle 350 slidably disposed in a needle cavity 360 behind the connection opening, see Figure 5D. The needle chamber is formed by these layers of the pump and includes an inner sealing membrane 315 through which the needle is slidably disposed, the membrane being formed by said first membrane layer. The needle comprises: a pointed distal end 351; a proximal end at which a needle plunger 352 is located; a proximal opening 353 in fluid communication with the distal end, the needle and plunger relative to the inner septum and lumen is set slidably. As can be seen in Figure 5D, the needle piston in its initial position is bypassed by one or more radially disposed keyways 359, which are provided to allow steam sterilization to When moving, expel air that would otherwise be trapped inside.

The pump assembly described above may be provided in a drug delivery device of the type shown in FIG. 2 . In the state of use connecting the reservoir unit to the needle unit, the proximal end of the infusion needle is introduced through the outlet seal of the pump and the septum 334 and the connecting element 525 (see FIG. 2 ) is guided through the connecting membrane 333 . By this action, the connecting needle is pushed from its initial position shown in FIG. 5D to the actuated position shown in FIG. 5E , wherein the distal end moves through the inlet membrane 331 and further through the needle of the adjacent reservoir. The penetrable septum thus forms a fluid path between the reservoir and the inlet valve through the proximal opening 353 in the needle. In this position, a seal is formed between the needle piston and the needle chamber.

As shown, when the two units are disconnected, the infusion needle 212 is withdrawn from the pump outlet, while the connecting needle permanently provides fluid communication between the pump and the reservoir.

Another configuration of a flexible pre-filled drug reservoir suitable for use in a delivery device of the type shown in Figures 1 and 2 will now be described with reference to Figures 6A-6C and 7A-7C.

The flexible reservoir 400 comprises first and second flexible wall foil elements 404, 405 which are sealed together at their peripheries by a welded seam 406 forming a relatively flat pouch, For containing liquid medication, the welded seams of the pouch define a general plane. The elastic membrane element 410 is mounted on the first foil element, preferably by welding. The septum element comprises a relatively thin disc-shaped base portion, from the central portion of which protrudes an extension 411, the peripheral peripheral portion 412 of which base portion forms a needle-penetrable self-sealing connection. The protrusions and mounting means can be utilized to secure the reservoir relative to other components during manufacture or handling of the reservoir without interfering with movement of the flexible foil walls.

Although the filled reservoir 400 has a generally convex, needle-permeable first surface that allows insertion of the needle generally parallel to the general plane of the reservoir, FIGS. 7A-7C illustrate the configuration of the reservoir. , this configuration improves insertion of the needle through the needle-penetrable portion 412 of the septum parallel to the general plane of the reservoir.

More specifically, by deflecting a portion of the reservoir downward relative to the general plane (e.g., by about 30 degrees as shown in FIG. The needle 450 is arranged parallel to the general plane of the reservoir so that the needle can be easily inserted. As shown in FIG. 7A, the curved reservoir includes a first "major" portion 415 and a second "minor" portion 416, said first "major" portion 415 being disposed substantially corresponding to said general plan, said The second "minor" portion 416 is biased relative to the first "main" portion in a direction away from the first surface such that a portion 413 of the peripheral portion of the diaphragm element is disposed on the second portion of the reservoir. In Figures 7A-7C, the reservoir is shown without means for bending the reservoir, however, such means could be provided by some member surrounding the housing. Needle 450 may be in the form of the removable needle hub described above.

Example: A reservoir containing 3ml of insulin is manufactured from two foil elements in a three-layer laminate comprising an intermediate layer made of PCTFE and epoxy Co-extruded epoxy modified polyethylene imine (bonding layer); an inner layer consisting of PE; an outer layer consisting of PP and laminated on PCTFE layer. Before welding the two foil elements together along their peripheries, a diaphragm element made of a thermoplastic elastomer compound is welded to the outer PP layer, and the insulin is filled before the reservoir is completely sealed. Inject into the reservoir.

In the above description of the preferred embodiment, different components and devices providing the described functions for different components have been described, and this description is enough for those skilled in the art to clearly understand the concept of the present invention. The detailed configuration and specifications of the various components are considered to be a conventional design that can be obtained by those skilled in the art following the contents described in the specification of the present invention.

Claims (12)

1. delivery device comprises:

Shell (251,551),

Installing device (562,675,677,780) is set up in the enclosure or by shell and forms,

Have the flexible reservoir (260,560,660) of outer surface part, be suitable for holding fluid, at least a portion of flexible reservoir is set up in the enclosure,

Diaphragm element (261,561,661), this diaphragm element is formed by the transparent flexible material of pin, wherein,

Described reservoir comprises the first and second flexible foils parts, and this first and second flexible foils part is sealed together, thereby is formed for holding fluidic sealing chamber, and described reservoir has a bag columnar structure,

Diaphragm element is installed on the outer surface part of reservoir by welding manner, and

Installing device engages with diaphragm element, so that with respect to installing device flexible reservoir is installed.

2. a device according to claim 1 is characterized in that, except diaphragm element, whole basically flexible reservoir can move freely with respect to installing device.

3. device according to claim 1 also comprises:

Fluid line (350), this fluid line has entrance and exit, and the inlet of this fluid line is suitable for being configured to form fluid by diaphragm element (261) and reservoir and is communicated with,

Wherein, fluid line and reservoir can relatively move from an initial position and a link position, and at initial position, fluid line and reservoir not fluid are communicated with, and at link position, the fluid line inlet forms fluid with reservoir by diaphragm element and is communicated with.

4. device according to claim 2 also comprises:

Fluid line (350), this fluid line has entrance and exit, and the inlet of this fluid line is suitable for being configured to form fluid by diaphragm element (261) and reservoir and is communicated with,

Wherein, fluid line and reservoir can relatively move from an initial position and a link position, and at initial position, fluid line and reservoir not fluid are communicated with, and at link position, the fluid line inlet forms fluid with reservoir by diaphragm element and is communicated with.

5. a device according to claim 3 is characterized in that, the inlet of fluid line is the form of the pin part of point, and diaphragm element is formed by self-sealing material.

6. a device according to claim 4 is characterized in that, the inlet of fluid line is the form of the pin part of point, and diaphragm element is formed by self-sealing material.

7. one kind according to the described device of one of claim 1-6, also comprises expulsion assembly (270), and this expulsion assembly is suitable for being communicated with by formed fluid in the diaphragm element discharges the fluid that is contained in the reservoir.

8. one kind according to the described device of one of claim 1-6, also comprise expulsion assembly (300,670), this expulsion assembly has inlet (321,672) and the outlet (322) and this expulsion assembly entrance and exit between the internal circulation path, the inlet of described expulsion assembly is suitable for being configured to form fluid with reservoir and is communicated with, and the expulsion assembly is suitable for discharging the fluid that is contained in the reservoir by the outlet of expulsion assembly.

9. a device according to claim 8 is characterized in that, the expulsion assembly comprises fluid coupling (350), and this fluid coupling is used as the inlet of expulsion assembly,

Wherein, in original state, fluid coupling (350) is set at the inside of expulsion assembly, fluid coupling includes inlet (351) and outlet (353), thereby fluid coupling is configured to be operated into a mode of operation from original state, in mode of operation, between reservoir inside and expulsion component internal, form fluid and be communicated with, and the outlet of fluid coupling is set in the circulation path of expulsion assembly through fluid coupling.

10. device according to claim 8 also comprises:

Transdermal equipment (212) is suitable for penetrating curee's skin,

Surface (232) is installed, is suitable for being applied on curee's the skin,

Wherein, reservoir comprises fluid medicine, and

In user mode, driven unit is used for described medicine is discharged from reservoir, and the skin through transdermal equipment and by the curee.

11. a device according to claim 9 also comprises:

Transdermal equipment (212) is suitable for penetrating curee's skin,

Surface (232) is installed, is suitable for being applied on curee's the skin,

Wherein, described reservoir comprises fluid medicine, and

In user mode, driven unit is used for described medicine is discharged from reservoir, and the skin through transdermal equipment and by the curee.

12. the method that flexible reservoir is installed comprises step:

Provide the structural support (251,551), this supporting construction comprises installing device,

Flexible reservoir is provided, this flexible reservoir comprises the transparent flexible partition element of pin, the flexible partition element is installed on the outer surface part of reservoir by welding manner, described reservoir comprises the first and second flexible foils parts, this first and second flexible foils part is sealed together, thereby be formed for holding fluidic sealing chamber, described reservoir has a bag columnar structure, and

Engage diaphragm element and installing device, so that described reservoir is installed with respect to described installing device.

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