MXPA98001895A - Medication supply device - Google Patents
Medication supply deviceInfo
- Publication number
- MXPA98001895A MXPA98001895A MXPA/A/1998/001895A MX9801895A MXPA98001895A MX PA98001895 A MXPA98001895 A MX PA98001895A MX 9801895 A MX9801895 A MX 9801895A MX PA98001895 A MXPA98001895 A MX PA98001895A
- Authority
- MX
- Mexico
- Prior art keywords
- container
- delivery device
- medicament
- reservoir
- housing
- Prior art date
Links
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- ZLMJMSJWJFRBEC-UHFFFAOYSA-N potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 235000011056 potassium acetate Nutrition 0.000 description 1
- 230000003389 potentiating Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000036633 rest Effects 0.000 description 1
- 230000000284 resting Effects 0.000 description 1
- 229960002646 scopolamine Drugs 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000037380 skin damage Effects 0.000 description 1
- NHXLMOGPVYXJNR-ATOGVRKGSA-N somatostatin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@@H](CC=2C3=CC=CC=C3NC=2)C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N1)[C@@H](C)O)NC(=O)CNC(=O)[C@H](C)N)C(O)=O)=O)[C@H](O)C)C1=CC=CC=C1 NHXLMOGPVYXJNR-ATOGVRKGSA-N 0.000 description 1
- 229960004532 somatropin Drugs 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- GGCSSNBKKAUURC-UHFFFAOYSA-N sufentanil Chemical compound C1CN(CCC=2SC=CC=2)CCC1(COC)N(C(=O)CC)C1=CC=CC=C1 GGCSSNBKKAUURC-UHFFFAOYSA-N 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229960003726 vasopressin Drugs 0.000 description 1
- 229960001722 verapamil Drugs 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
Abstract
A medicament delivery device 10 having a reservoir within a housing 11 and means for propelling the medicament from the reservoir is described. The device is provided with a filling mechanism on which a medicine container 19 sealed through a penetrable plug 25 is mounted. The mechanism comprises an internal hole 20, which is adapted to an internal rod 21, from which a needle 22 projects. The needle 22 is hollow and is in communication with the reservoir. In order to fill the reservoir, the container 19 is compressed in the hole 20, causing the needle 22 to puncture the plug 25, the cap abuts against the rod 21 and acts as a piston to propel the medicament from the container 19, to as the container 19 is pushed towards the hole 20 and moves relative to the plug 25. In this way, the reservoir can be filled with the sterile medicament with which it is stable when stored in the container 19, the filling is achieved easily without the use of a syringe. An advantageous additional aspect is provided through a supply needle, which is mounted on the periphery of the lower surface of the housing. This configuration allows the drive means to be located adjacent to the skin, thus providing a more stable temperature and more predictable operation of the device.
Description
MEDICATION SUPPLY DEVICE
TECHNICAL FIELD
This invention relates to drug delivery devices for the delivery of pharmacological, biological and nutritive substances to a human or animal, in the form of a liquid, suspension solution or other flowable form such as a flowable gel
BACKGROUND OF THE PREVIOUS TECHNIQUE
The drug delivery devices for delivering drugs to a patient generally comprise a reservoir for the medicament and means for supplying the medicament to the patient. The reservoir may be pre-filled with a medicament, or the device may be provided with means for filling the reservoir Typically, said means may be a self-sealing shutter, which can be pierced with a syringe to allow the medication to be injected into the reservoir. There is awareness regarding pre-filled medicament delivery devices with respect to stability and storage characteristics of the drug. medication within the warehouse Regulatory authorities are reluctant to approve products that have a potentially long storage residence if the medication is stored in, for example, an elastomeric reservoir (many devices have a reservoir attached, in part, through a flexible diaphragm , he which is used to compress and deliver the medication) Generally, drugs are probably more stable and regulatory approval is easier to obtain if the drugs are stored in glass jars, as is traditional with drugs. In addition, some drugs are unstable when stored in liquid form, and thus require reconstitution, dilution or dissolution from a solid or semi-solid form before use. If the deposit is to be filled before use, and if administration by part of the patient is desired, there are many aspects about the filling by the patient, the reservoir, where a syringe is used for this purpose, for safety reasons, incorrect dosage or procedural error The present invention seeks to address these problems and provide means for storing drugs in a stable condition for extended periods and subsequently filling said device for supplying the drug quickly, easily and safely Another problem associated with drug delivery devices refers to the speed of delivery of the drug therefrom In general, driving means are used to supply The medicament from the reservoir after the reservoir has been filled. The currently preferred delivery means employs a gas generator such as an electrolytic cell to generate a gas and push the medicament from the reservoir. This type of delivery means may be preferred because at its reliable and controllable supply speed However, it is usually the case that variations in temperature affect the gas generation speed and the gas volume already generated (and the same can also be true for other driving media). ) Accordingly, the invention seeks to provide an arrangement, which minimizes variations in the rate of supply that arise from environmental temperature variations. Another object of the invention is the provision of a device which is easier to apply to the skin than other devices of the prior art such as the device described in WO 95/13838. It uses a removable cover, which jumps from a position where the needle is hidden to a position where the needle is exposed. The cover is placed against (and adheres to) the skin and then the device is compressed on the skin, causing the device to jump on the cover, the needle penetrating the skin through a centrally arranged opening of the cover Since this arrangement has a number of advantages, including the inherent safety aspect of having a needle protected by the removable cover, the needle can only be exposed when the jump cover moves up relative to the device, a good amount of force may be required to fix the device on the cover. A further object of the invention is to provide a device, which gives a visual indication of the level of medication remaining for delivery, since this allows the patient or physician to replace the device as soon as the supply is completed, if necessary. Devices that are used adjacent to the skin are not suitable for use with certain medications, since some medications (such as many polypeptides) are unstable at temperatures as low as human body temperature during extended periods.
DESCRIPTION OF THE INVENTION
The invention provides a medicament delivery device comprising a housing, a reservoir within the housing, a filling mechanism for the integral reservoir with the housing and means for propelling the medicament from the filled reservoir, the filling mechanism being adapted to receive a container for the medicament, said container being sealed by a penetrable cap, and the filling mechanism comprising means for penetrating the cap, said penetrating means being in communication with the reservoir to allow the medicament to be transferred from the container to the reservoir at Through the filling mechanism it will be appreciated that said device allows the medicament stored in a container, such as a vial or vial, to be charged directly to the delivery device without the use of a syringe, thus eliminating the aspects with respect to patient error in filling the reservoir, while also allowing While the medicament is stored for an extended period before being used in a sterile condition Preferably, the container is able to slide into the medicament, the cap makes a leak-proof slide fastener with the interior of the container. Also, preferably, the housing it is provided with a hole, which receives the container and the penetration means are arranged on a stop inside the hole, so that the plug is penetrated and rests against the stop when the container is pushed along the hole, the penetrated plug acting as a piston to deliver the medication from the container In this way, the penetrating means may be depressed within the housing, avoiding the risk of damage to the person filling the device or subsequent damage when the device is discarded. Device filling action is extremely simple, merely requiring that the container It is pushed along the hole This action causes the penetration of the plug and the expulsion of the contents of the container through the opening created in the plug through the penetration means. Since the medication is sealed inside the container until the cap is penetrated and since no external means are used to transfer the medication into the reservoir, sterility can be ensured. This is not the case where a syringe must be used to withdraw the medication from a vial or ampoule and subsequently inject the medication into a reservoir. The reference to piston-type actuation means simply that the plug moves relative to the container (i.e., the plug can be held in place and the container moved, unlike a regular piston, which moves as the cylinder remains fixed). According to a preferred embodiment, the penetrating means comprise a hollow needle and the stop is a bar extending inside the hole, the needle communicating with the reservoir through a conduit that extends internally in the bar. A hollow needle communicating with the reservoir through a conduit is particularly suitable as it allows easy penetration and transfer of the medicament into the reservoir. The bar that extends into the hole provides a structure, which allows the transfer of medication through the internal passage, and which allows a container, such as a cylindrical bottle, to be pushed along the hole, the bar being adapted inside the cylinder as the cylinder empties. Preferably, the container leaves the housing before use and moves to a depressed position within the housing when the reservoir is filled with the medicament. This arrangement is particularly suitable, since it allows easy disposal of the entire device, including the container, which does not have to be disposed of separately. This is particularly important since the disposal of containers containing small amounts of potent drugs is an obvious health hazard, if the children will have access to the containers after discarding them. This can happen, for example, when the delivery device is used for self-administration by patients at home. The arrangement further reduces any possibility of incorrect filling of the reservoir, since the container, which leaves the device, merely has to be pushed from a resting position to a depressed position within the housing to ensure that the reservoir has been properly filled. In a preferred embodiment, the container is integral with the housing. This embodiment is particularly preferred in many applications for reasons of hygiene and sterility. By mounting the container on the housing during assembly, and preferably making the container as an integral part of the device, a sealed assembly is provided, which can be designed to eliminate any possibility of contamination or alteration with the medication. In this way, a device can be obtained which is effectively salable as a pre-filled device, but which eliminates the aspects on the conditions under which the medication is stored during the storage life of the device. Alternatively, under suitable circumstances, the container is separated from the housing and mounted therein before use. This modality may be more appropriate if the device (other than the container) was sold as a medically-general-purpose delivery device, with a scale of types of drugs and strength available for use with the device. This option also allows the use of a reconstitutable or soluble drug, which can be stored in a container in solid form, and reconstituted or dissolved immediately before use, and the container can then be fixed to the housing and the medication added to the reservoir. Since such an arrangement may not be as inherently hygienic as a sealed assembly, it nevertheless offers the possibility of a safe, accurate and reliable filling mechanism for use with drugs that might otherwise be unstable if stored in a delivery device. of medication. It may also be the case that when a solid or semi-solid drug is stored in a sealed container, and is subsequently reconstituted, diluted or suspended, the plug is punctured during the addition of the liquid medium, at which point it is provided with a small hole . In such circumstances, however, the container is still considered a "sealed" container through the penetrable plug. Accordingly, the invention encompasses the device as such, when supplied without the container (but the filling mechanism is adapted to receive a container which is sealed through the penetrable plug). Suitably, the penetrating means partially penetrates towards but not completely through the plug before use. This arrangement helps to retain the plug in the correct position in relation to the penetration means, reduces the force necessary to completely penetrate the plug and ensures a correct penetration of the plug. The invention also provides a medicament delivery kit comprising: (a) a medicament delivery device comprising a housing, a reservoir within the housing, a filling mechanism for the integral reservoir with the housing and means for driving the medicament from the filled reservoir, the filling mechanism being adapted to receive a container for the medicament, said container being sealed through a penetrable cap, the filling mechanism comprises means for penetrating the cap, the penetrating means being in communication with the deposit to allow the medication to be transferred from the container to the reservoir through the filling mechanism; and (b) a sealed container through a penetrable plug, said plug making a leak-proof sliding fastener with the interior of the container. Said equipment is inherently safer and more hygienic than a medication delivery device, which is filled through a syringe, since the syringe must first be extracted in the medicament and subsequently injected, and thus implies the possibilities of contamination of the medication. In addition, it is preferred to remove the syringes as much as possible due to the hazards associated with contamination or needle damage. Suitably, the driving means comprise a gas generating apparatus. According to a preferred embodiment, the gas generating apparatus is in the form of an electrolytic cell. Suitably, the electrolytic cell incorporates a battery. In an alternative embodiment, the gas generating apparatus comprises two substances, which when contacted react to generate a gas. Preferably, the substances are an acid and a base. In the currently preferred embodiment, citric acid and sodium bicarbonate are used, mainly due to their easy reaction and non-toxicity, as well as the inert nature of the reaction products (carbon dioxide and water). According to another embodiment, the driving means comprise an inflatable gel. Preferably, the inflatable gel is incated upon contact with a liquid and the delivery means further comprises a container containing said liquid, and means for contacting the liquid and the gel. As indicated above, the medicament can be provided in the form of a solid or semi-solid material, which is reconstituted with a liquid form before using the device. Preferably, in such a case, the medicament is provided as a lyophilized solid. The invention also provides a medicament delivery device comprising a medicament having a surface contact with the skin, a reservoir within the housing, a hollow needle communicating with the reservoir extending, during use, through the periphery of the surface of contact with the skin, and means of driving to propel a medicament from the reservoir towards a patient through the needle. The arrangement of a water on the periphery of the surface that is in contact with the skin (that is, towards the edge of the surface instead of the central area of the surface) gives rise to a number of advantages in terms of the design of the design of the device and manufacturing costs, and in terms of ease of application of the device to the skin, as will be discussed below.
Similarly, the driving means are located intermediate to the reservoir and the skin contact surface. In this way, the driving means are close to the skin and are maintained at a temperature close to the skin temperature of the subject. In the same way that the back of a watch is maintained at a regular temperature, since the temperature of the watch face can vary substantially, the drive means of the device according to the invention are maintained at a regular temperature. , this increases the accuracy and reliability of the speed at which the medication is driven from the reservoir, leading to an improvement in the safety of the device by providing a regular dosage of the medication to the patient. Having the means of delivery closest to the skin that the tank, it is possible to place the tank adjacent to the upper surface of the tank. Having a transparent or translucent upper surface (or having a portion of the upper surface, which is transparent or translucent), a visual indication can be provided regarding the level of medicament in the reservoir. The appropriate configuration of the upper surface allows the Drug volume is calibrated or, alternatively, allows a simpler indication, which merely shows that it is time to replace or refill the device. This prevents a patient from believing that the device is supplying the medication when in fact it is empty. Providing a deposit in the top surface of the device and having a transparent top cover also allows a visual inspection of the medication Regulatory authorities usually require data sheets to perform a precaution such as "parenteral drug products should be visually inspected for particulate matter and discoloration Before administration, each time the solution and the container allow it "This can be achieved using the previous configuration. This configuration provides an important additional advantage, since it places the tank away from the heat of the skin, allowing the medication to be maintained at a lower temperature than in the prior art If necessary, the tank can be thermally insulated to prevent conduction of heat from the body through the drive means This allows the drugs, which are unstable at higher temperatures they are used safely in a device that is used close to the skin. Thermal insulation of the device can be achieved to any desired degree, that is, the deposit can be totally enclosed by an insulating material or only the lower surface of the deposit (closest to the skin) can be isolated In many cases, the boundary between the deposit and the means of impulse n is a membrane of some type, in which case a suitable insulating material can be chosen to be used as a membrane. Preferably, the driving means have a substantially planar configuration and are arranged parallel to the skin contacting surface. This arrangement maximizes the volume of the driving means, which lie close to the skin, helping to maintain a regular temperature. Most preferably, the drive means are located immediately above the skin contact surface. As discussed above, the drive means may comprise a gas generating apparatus in the form of an electrolytic cell. The cell preferably comprises upper and lower plates and an electrolytic intermediate of said plates optionally including a battery. This type of cell is easy to manufacture, gives rise to the flat configuration presented above, and can be manufactured inexpensively as an independent component, which is incorporated in a scale of drug delivery devices. If one of the plates is the cathode and the other is the anode, one or both can be made of a material that conducts heat efficiently for the reasons given above. In an alternative embodiment, the cell comprises a reservoir for a liquid electrolyte attached in one part by a gas-permeable membrane, impervious to liquid, optionally including a battery. The hydrophobic membrane prevents the liquid electrolyte (preferably a diluent electrolyte such as a solution of potassium acetate or dipotassium diphosphate) from drying out. Said cell can also be made in a flat configuration and placed adjacent to the contact surface with the skin. The gas generator may comprise two substances, which when contacted react to generate a gas, suitably an acid and a base, and in one embodiment, citric acid and sodium bicarbonate. A gas generator depending on the chemical reaction benefits strongly as it is placed close to the skin. In another embodiment, the driving means comprises an inflatable gel. Suitably, the inflatable gel swells upon contact with a liquid and the delivery means further comprises a container containing a liquid, and means for contacting the liquid and the gel. As a rule, any of the above types of drive means (or, in fact, alternative suitable drive means) benefit from having the needle extend through the periphery through the skin contact surface, since this it allows the placement of the intermediate drive means to that surface and the tank without having a conduit passing through half of the drive means, an arrangement, which is more difficult and expensive to design and manufacture. In a preferred embodiment, the contact surface with the skin is in the form of a cover attached to the housing, said cover being able to move between first and second positions, the needle being hidden by said cover when the cover is in a first position, and The needle is exposed when the cover is in the second position. The cover provides a secure appearance in a number of ways. Before use, the cover conceals the needle, thus preventing accidental damage from occurring. In addition, the needle, being hidden, will not pick up any contamination, making it more sterile when it is placed on the skin. The cover can be moved to the second position through the application of the device to the subject's skin, in the manner that the needle only emerges when the deposit has been applied. After removal of the device, the cover can be moved back to the first position and thus hide the needle and allow safe disposal of the device or allow storage of the device to be reused, if desired. Preferably, said cover it is mounted on the housing through a hinge mechanism. Accordingly, the cover can be placed against the skin in the first position with the hinge allowing the device to be compressed or towards the skin causing the needle to come out through the cover and pierce the skin when the cover is in the second position . Preferably, the needle exits through the cover at a point distant from the hinge. This makes it easier to pierce the skin with water since a force is made when pushing the housing towards the skin. Preferably, the cover is provided with a jump mechanism allowing jumping between the first and second positions. This provides the most effective penetration of the skin, since the jump mechanism causes the needle to inflate the skin quickly (opposite the user who compresses the needle slowly towards and through the skin). The provision of a hinge and a jump mechanism provides a less traumatic and painful application of the device. Typical drugs suitable for use with the device according to the invention include peptides., proteins or hormones such as insulin, calcitonin, calcitonin gene regulation protein, colony stimulation factor of atpal natrophetic protein, betaseron, eptropoietin (EPO), interferons such as α, β or β-interferon, somatropin, somatotropin, somatostatin, insulin-like growth factor (somatomedins), luteinizing hormone-releasing hormone (LHRH), tissue plasminogen activator (TPA), growth hormone-releasing hormone (GHRH), oxytocin, estradiol, growth hormones , leuprolide acetate, factor VIII, interleukins such as nterleucin-2 and analogous thereof, analgesics such as fentanyl, sufentanil, butorphanol, butrenorphine, legorphanol, morphine, hydromorphone, hydrocodone, oxymorphone, methodone, hdocaine, bupivacaine, diclofenac, naproxen, pavepna and analogs thereof, anti-migraine agents such as sumatpptan, ergot alkaloids, and analogs thereof, anticoagulant agents such as hepapna, hirudin, and analogs thereof, anti-emetic agents such as scopolamine, ondanesetron, dompepdone, metoclopramide and analogues thereof, cardiovascular agents, anti-hypertensive agents and vasculature vessels such as diltiazine, clonidine, nifedithine, verapamil, 5-isosorbide mononitrate, organic nitrates, agents used in the treatment of heart disorders, and analogous thereof; sedatives such as benzodiacetins, phenothiocins and analogues thereof; narcotic antagonists such as naltrexone, naloxin, and analogs thereof; chelating agents such as deferoxamine, and analogs thereof; anti-diuretic agents such as desmopressin, vasopressin and analogs thereof; anti-anginal agents such as nitroglycerin and its analogues; neoplastic agents such as 5-fluoracil, bleomycin and analogs thereof; prostaglandins and analogs thereof; and chemotherapeutic agents such as vincristine and its analogues. The invention will now be illustrated further through the following description of the modalities thereof given by way of example only with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a plan view, partially in section of a device according to the invention before use; Figure 2 is an elevation in sections of the device of Figure 1, taken along the line ll-ll; Figure 3 shows the device as illustrated in Figure 1 when used;
Figure 4 shows the device illustrated in Figure 2 when used; Figure 5 is a perspective view of the gas generator of the device illustrated in Figures 1-4; Figure 6 is a sectional elevation of the gas generator shown in Figure 5; Figure 7 is a longitudinal sectional view of a container adapted for use in the present invention; Figure 8 is an elevation view of a second embodiment of the medicament delivery device according to the invention; Figure 9 shows the device as illustrated in Figure 8 in use; Figure 10 is a perspective view of a gas generator for use in a device according to the invention; Figure 11 is a sectional view of the generator of Figure 10; and Figure 12 is a section elevation of a third embodiment of the liquid delivery device according to the invention.
MEANS FOR CARRYING OUT THE INVENTION
In Figures 1 and 2, a medication delivery device according to the invention is illustrated, generally at 10. The device 10 comprises a housing, in which there is a reservoir 12 for holding a medicament before being delivered via a conduit 13 to a hollow supply needle 14 extending through the periphery of the lower surface of the device 10. The needle 14 can perform intradermal, transcutaneous or intramuscular delivery. A gas generator 15 comprising a battery 16 and an electrolyte 17 is used to generate a gas, thus forcing an elastomeric diaphragm 18 upwards to pressurize the medicament contained in the reservoir 12 and medically ejected through the needle 14. The operation of said device is described in WO 95/13838. Before use, the device is filled from a container 19, which extends from the housing 11 of the device. The housing 11 has an internal hole 20 in which the container 19 is slidably received when pressure is applied to the container 19 to compress it in the housing 11. The hole 20 fits an internal bar 21, which acts as a stop and starts from which a hollow needle 22 is projected 22. The bar 21 has an internal passage 23, which allows the needle 22 to communicate with the reservoir 12. The container 19 is filled with a medicament 24 and sealed through a stopper elastomeric, longitudinally slidable 25. The needle 22, before use, penetrates but not through the elastomeric stop 25. When the container 19 is compressed in the hole 20, the needle 22 pierces through the stopper 25, and then the stopper 25 abuts the bar 21. Additional movement of the container 19 towards the housing 11 causes the plug 25 to act as a piston (since it remains in a position relative to the housing, while the cylindrical container 19 is ueve towards the accommodation). This causes the medicament 24 to be compressed and is expelled from the container 19 through the needle 22 and from the conduit 23 towards the reservoir 12. A filter (not shown) in the conduit, serves as a safety precaution to remove the possibility of accidental contamination of the drug by solid particles. The container 19 is integrally assembled with the housing 11, and is delivered to the patient as shown in Figures 1 and 2. It will be appreciated that all that is required to fill the reservoir of the sterile, sealed container 19 is the container 19 in the hole 20 of the housing 11. Through the process, that is, before, during, and after use, the needle 22 remains hidden. In this way, the device 10 (including the container 19) must be easily discarded without the danger of damage or misuse. The operation of the device will now be described. The gas generator 15 is operated through a switch 26 adjacent a base cover 27 as described below. The cover base 27 hides the supply needle 14 before use. The lower surface 28 of the base cover 27 is coated with an adhesive. When it is desired to use a device (i.e., after the container 19 has been compressed in the housing 11 to carry the reservoir 12), the device 10 is compressed against and adhered to the skin. A jump mechanism 29 allows the cover 27 to jump upward under the applied pressure, as the cover 27 joins the housing 11 of the device 10 through a hinge 30. The needle 14 pierces the skin as a result of this action and the cover 27 operates switch 26, thereby causing gas generation and subsequent delivery of medication from reservoir 12 through conduit 13 and delivery needle 14 to the patient. It will be appreciated that the jump mechanism 29 and the hinge 30 are more efficient than a jump mechanism where the entire device must jump on the deck. It requires a good force of small amount to fix by jump the cover in its place where a hinge that acts as a fulcrum is used. This makes the application of the device less powerful, which can help the patient's complaint and acceptance. Furthermore, since the needle 14 is placed on the periphery of the surface defined by the cover 27, it travels approximately twice as fast when the cover 27 per jump is activated since if it were placed in the center of the device (i.e. double as close as possible to the hinge). This leads to a less traumatic and less painful perforation of the skin, since experience shows that a needle that quickly punctures the skin damages less than a needle that is slowly compressed into the skin.
Figures 3 and 4 show the device 10 of Figures 1 and 2, when in use. In this way, it can be seen that the container 19 is completely compressed in the housing 11, the plug 25, being held in place by the bar 21, has moved through the length of the container 19, thereby completely emptying the container. container 19 of the medication. The medicament 24 has been discharged through the needle 22 and the internal conduit 23 into the reservoir 12 (Figure 4). Since the device 10 has been compressed against the skin of the patient, the base cover 27 has been fixed by jumping upward, exposing the needle 14 and allowing the supply of medicament 24 within the reservoir 12 through the skin. Figures 5 and 6 show the gas generator of the device of Figures 1-4 in great detail. Figure 5 shows that the generator, generally illustrated at 40, is in the form of a circular disc 41 having a flexible raised contact 42 extending therefrom. In Figure 6, it can be seen that the generator comprises a battery 43 and an electrolyte 44, the electrolyte being in contact on one side with a cathode 45 and extending from the battery 43, and on the other side with an anode in the form of a contact 42. It will be appreciated that the gas generator as illustrated does not generate gas until the contact 42 has been compressed to touch the battery 43, thus completing the circuit. In this way, when the gas generator is incorporated (in the inverted position) to the device illustrated in Figures 1-4, gas generation only begins when the base cover 27 (see Figures 2 and 4) has been set by jump upward as the device 10 is compressed against the patient's skin. When the gas generator 40 is incorporated in the device 10, it lies parallel to the contact surface with the skin. The substantially flat configuration of the generator 40 maximizes the surface area and volume of the generator that lies close to the skin. It can be seen from Figures 2 and 4 that the internal components of the device 10 are arranged to have the gas generator intermediate the tank and the skin, an inversion of the conventional configuration. It has been found that the configuration shown in Figures 2 and 4, however, is preferred since the electrolytic cell remains at a temperature very close to the temperature of the skin. Once calibrated, the rate of gas generation and therefore the drug supply can be reliably predicted and utilized. Not only does the rate of gas generation vary less, but the volume of gas below the membrane 18 also fluctuates less. The placement of the needle 14 at the periphery of the skin contact surface 27 allows this configuration to be exploited using the less expensive and simple electrolytic cell of Figures 5 and 6. Generally, the placement of the cell between the reservoir and The skin could be expected to involve an electrolytic cell design that allows a conduit to pass through the reservoir towards the needle. This can be done if necessary, but if it is desired to use a cell produced separately for subsequent inclusion in the device, then the cell must have a delicate design, such as an annular design. This problem is overcome by diverting the needle from the reservoir side to extend through the periphery and the skin contact surface. This arrangement is advantageous not only with electrolytic cells and other gas generators, but also with any type of temperature-dependent driving means. Figure 7 illustrates a container for use with the device according to the invention. The container, generally illustrated 50, comprises a container body 51 in the form of a glass bottle containing a medicament 52, and sealed through a penetrable elastomeric cap 53 The container 50 can be sold separately from a device such as that illustrated in Figures 1-4, or may be sold in the equipment in the form of equipment with device according to the invention. In Figures 1-4, the device is shown as being attached in a preferred embodiment, with the container pre-mounted on the device. , this is not the only way to supply the device, the individual type of device can be sold together with a wide variety of containers in the form of container 50, each different container having a different type of drug or a different resistance to the drug Figure 8 illustrates a second embodiment of the device according to the invention. The device, generally indicated at 60, is in many ways similar to the device illustrated in Figures 1-4, except that different means of delivery are used to deliver the medicament. of flow comprise an inflatable gel 61 located in a compartment 62 together with a drip-proof water container 63 Making re Referring to Figure 9, it can be seen that when the supply 60 is applied and adheres to the skin, a cover 64 is fixed by jumping upwards and causes the needle 65 to pierce the container 63, releasing the water and thus moistening the gel 61, which causes the gel 61 to swell, and in this way displaces a membrane 66 to effect the delivery of medicament from the reservoir 67 in a manner similar to the supply effected by the generation of gas in the device of the Figures 1-4 Another embodiment of the invention has the same configuration illustrated in Figures 8 and 9, but the gel 61 is replaced by sodium bicarbonate, and the container 63 contains a solution of citric acid instead of water When the container 63 is perforated as the cover 64 is fixed by jumping upwards, the citric acid is released to contact the sodium bicarbonate, thus generating carbon dioxide to propel the medication from the depo The mode having an inflatable gel is preferred because of its slow release of medicament during, for example, 12, 24 or 48 hours. The mode having an acid and a base is suitable for a rapid supply. minutes or less, if desired Figures 10 and 11 illustrate an electrolytic cell alternative to that shown in Figures 5 and 6 The cell as generally indicated at 70, comprises a flat cylindrical housing 71 incorporating a battery 72 and an electrolyte reservoir The reservoir 73 is closed above and below through a pair of hydrophobic membranes 74, 75, which are gas permeable and liquid impervious. The reservoir 73 is filled with a diluent electrolyte, such as an aqueous acetate solution. of potassium (CH3COOK) 76 Alternative electrolytes, such as a solution of dipotassium acid phosphate (K2HPO4), will be known to those skilled in the art. Hydrophobic membranes 74, 75 prevent the electrolyte 76 from drying out during extended storage, but allows the release of gas from the reservoir 73 A cathode 77 and an anode 78 extend through the reservoir 73 and generate a gas when connected to the reservoir. the terminals of the battery 72 through a pair of contacts 79, 80 The contact 80 (see Figure 11) must be compressed against the battery 72 to complete the circuit, and in this way the attachment by jump of a cover is properly effected. closed as described above. Different combinations of drive means can be employed. In this way, basal delivery rates can be obtained by having an inflatable gel or an electrolytic cell, combined with one or more acid / base compartments for the rapid delivery of the medication through the depression of a button causing a needle to pierce a compartment. This type of arrangement may be appropriate when the device is used for patient-controlled analgesia, that is, providing a constant low dose of pain killer with smaller, stronger release boosters. In Figure 12, a further embodiment of the liquid delivery device according to the invention is indicated generally at 90. The device comprises a housing 91 having a gas generation compartment 92 of the medicament reservoir 93. The compartment 92 and the reservoir 93 are separated through an elastomeric diaphragm 94. The reservoir 92 is in communication with a filling mechanism, indicated generally at 95, identical to the filling mechanism described in detail with reference to Figures 1-4. In this way, it comprises an internal hole 96 for receiving a cylindrical container, which can be supplied integrally with the reservoir 90 or can be supplied separately. In cases where it is supplied separately, the hole 96 can be covered before being used through a sterile elastomeric tongue such as a Tyrax tongue (Tyrax is a trademark), the tongue being removable before being used to allow access to the hole, at which point a container, such as the container illustrated in Figure 7, is inserted into the hole and pushed as previously described. The gas generating chamber 92 contains an electrolytic cell, which basically comprises a battery 97 that it communicates with a cathode 98 and an anode 99, the chamber 92 being filled with an electrolyte. After the cell is actuated a current flows between the cathode 98 and the anode 99 through the electrolyte, thereby generating a gas, which forces the diaphragm 94 downward to expel a medicament from reservoir 97 through the hollow needle 7 The electrolytic cell is also provided with a pneumatic contact. Source 101, which is part of the electrical circuit between the two fixed contacts 102, 103 The bridge contact 101 is mounted on a switch diaphragm 104 If the needle 100 is occluded or the reservoir 93 is emptied, the pressure is increased within the gas generation chamber 92 causing the switch diaphragm 104 to rise upwards, starting with the electrical circuit between the contacts 102 103. This is used as a safety aspect to avoid the continuous generation of gas when the supply is completed or the needle 100 is occluded. It will be understood that the reservoir 90 is provided with a movable cover 105, which is provided with an underground surface of adhesive 106 to be attached to the skin of the subject. The difference of the devices of Figures 1 4, and the Figures 8 and 9, the cover 105 is not mounted through a hinge mechanism, but rather is provided with jump mechanisms 107, 108, both of which are fixed n by jumping to the position shown in Figure 12 when the device 90 is applied to and compressed against the skin. It can also be seen that the needle 100 is mounted substantially in the center of the base of the device 90, and not on the periphery of the lower surface. Although this is currently less preferred (since a needle located on the periphery of the lower surface gives rise to a number of advantages, as described above), it nevertheless illustrates that the filling mechanism 95 can be integrated into a wide variety of medicament delivery devices, including a device 90, which is adapted from the device described in WO 95/13838. Since the device described in WO 95/13838 had to be pre-filled with a medicament or filled with a syringe through an injection port immediately before use, thus giving rise to the disadvantages stated above, the device 90, being provided with the filling mechanism 95, it is easier to use, safer, and more hygienic than the devices of the prior art. In an alternative embodiment, the cover 105 is mounted on the housing 91 through a screw thread, which replaces the jump mechanisms 107, 108. In this way, the cover 105 is applied to and adheres to the skin and the housing 91 is rotated relative to the cover 105, the thread of the screw making the cover withdrawal towards the housing, thus causing the needle to extend through the cover and pierce the skin. Optionally, a switch can be activated when the housing and the cover approach each other, thus starting the supply of medicament when the needle has penetrated the skin.
Claims (8)
1 - . 1 - A mechanism supplying device comprising a housing having a surface contacting the skin, a reservoir within the housing, a hollow needle communicating with the reservoir, the hollow needle extending, during use, through the periphery of the contact surface with the skin, and driving means for driving a medicament from the reservoir towards a patient through the needle
2 - A medicament delivery device according to claim 1, wherein the driving means are located intermediates to the reservoir and the skin contacting surface
3 - A medicament delivery device according to claim 2, wherein the driving means have a substantially planar configuration and are arranged parallel to the skin contacting surface. - The medication delivery device according to claim 3, wherein the delivery means are located immediately above the skin contact surface 5 - A medicament delivery device according to any of claims 1-4, wherein the driving means comprises a gas generating apparatus 6 - A delivery device for medicament according to claim 5, wherein the gas generating apparatus is in the form of an electrolytic cell 7. A medicament delivery device according to claim 6, wherein the electrolytic cell comprises upper and lower plates and an intermediate electrolyte to said plates 8 - A medicament delivery device according to claim 6, wherein the electrolytic cell comprises a reservoir for a liquid electrolyte attached in part through a gas permeable membrane, impermeable to liquid. - A medication delivery device according to claim 7 or 8, wherein the electrolytic cell The invention further comprises a battery 10 - A medicament delivery device according to claim 9, wherein the gas generating apparatus comprises two substances, which are brought into contact to react and generate a gas 11 - A delivery device of medicament according to claim 10, wherein the substances are an acid and a base 12 - A medicament delivery device according to any of claims 1-11, wherein the delivery means comprise an inflatable gel 13 - A medicament delivery device according to claim 12, wherein the inflatable gel swells upon contact with a liquid, and the delivery means further comprises a container containing a liquid, and means for bringing liquid into contact with the liquid. the gel 1
4 - A medicament delivery device according to any of claims 1-13, wherein a portion of the housing This is transparent or translucent thus allowing visual inspection of the contents of the reservoir 1
5 - A medicament delivery device according to any of claims 1-14, wherein the surface in contact with the skin is in the form of a cover attached to the housing, said cover moving between first and second positions, the needle being hidden by the cover when the cover is in the first position, and the needle being exposed when the cover is in the second position 1
6 - A drug delivery device according to claim 15, wherein the cover is mounted on the housing through a hinge mechanism 1
7 - A medication delivery device according to claim 15 or 16, wherein the cover is provided with a mechanism for jump allowing it to be fixed by jump between the first and second positions 1
8 - A device for the supply of medicamen according to any of claims 1-17, further comprises a filling mechanism for the integral reservoir with the housing the filling mechanism being adapted to receive a container for the medicament, said container being sealed through a penetrable cap, and the filling mechanism comprises means for penetrating the cap , said penetrating means being in communication with the reservoir to allow the medicament to be transferred from the container to the reservoir through the filling mechanism. 19. A medicament delivery device according to claim 18, wherein the container is capable of sliding within the housing, and the cap makes a leak-proof sliding fit with the interior of the container. 20 - A medication delivery device according to claim 19, wherein the housing is provided with a hole, which receives the container and the penetration means are arranged on a stop within the hole, so that the stopper is penetrated and abuts against the stop when the container is pushed along the hole, the plug penetrated acting as a piston to deliver the medication from the container. 21. A medication delivery device according to claim 20, wherein the penetration means comprise a hollow needle and the stop is a bar extending into the hole, the needle communicating with the reservoir through a conduit extending internally of the bar. 22 - A medication delivery device according to any of claims 18-21, wherein the container leaves the housing before use and moves to a depressed position within the housing when the reservoir is filled with the drug 23 - A medicament delivery device according to any of claims 18-22, wherein the container is integral with the housing 24 - A medicament delivery device according to any of claims 18-23, wherein the container is separated of the housing and mounts thereon before use 25 - A medicament delivery device according to any of claims 18-24, wherein the penetrating means partially penetrates but not completely through the stop before use. - A drug delivery equipment comprising (a) A medicament delivery device according to claim 18, and (b) a sealed container through a penetrable stop said stop makes a leak-proof sliding fit with the interior of the container 27 - A medicament delivery device according to any of claims 1-25, wherein the The medicament is provided in the form of a solid or semi-solid material, which is reconstituted into a liquid form before being used in the device 28 - A delivery or medication device according to claim 27, wherein the medicament is provided as a solid freeze 29. - A medicament delivery device according to any of the preceding claims, wherein the medicament is selected from peptides, proteins, hormones, analgesics, anti-migraine agents, narcotic anticoagulant agents, chelating agents, anti-anginal agents, chemotherapeutic agents, sedatives, antineoplastic, prostaglandins and antidiuretic agents 30 - A drug delivery device substantially as described above with particular reference to and as illustrated in the accompanying drawings 31 - A drug delivery equipment substantially as described above with particular reference to and as It is illustrated in the attached drawings
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US003673 | 1987-01-15 | ||
US367395P | 1995-09-11 | 1995-09-11 | |
IE950702A IE77523B1 (en) | 1995-09-11 | 1995-09-11 | Medicament delivery device |
IE950702 | 1995-09-11 | ||
PCT/IE1996/000059 WO1997010012A1 (en) | 1995-09-11 | 1996-08-30 | Medicament delivery device |
Publications (2)
Publication Number | Publication Date |
---|---|
MX9801895A MX9801895A (en) | 1998-05-31 |
MXPA98001895A true MXPA98001895A (en) | 1998-10-23 |
Family
ID=
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