INJECTOR DEVICE

Abstract: The invention concerns an injector device (1) for essentially simultaneous introduction of one or several media into or through a patient's skin (27), said device (1) comprising a carrier (2) arranged to be applied on the skin (27). The carrier (2) supports a plurality of needle means (7) intended for injection of the media, said plurality of needle means (7) arranged to be moved essentially simultaneously from a first position externally of the skin (27) to a second position in which said needle means have pierced or penetrated through the skin (27). The carrier (2) is formed with at least one membrane (10) arranged to actuate said needle means (7). The device (1) further comprises a pressure generating means (17) which is arranged to affect the membrane (10) by exerting pressure thereon to move said needle means (7) between said first and second positions.

Description: INJECTOR DEVICE The present invention relates to a device for introducing media into or through a patient's skin, and more particularly it relates to a device of the kind defined in the preamble of the appended claim 1 for essentially simultaneous introduction of one or several media into or through a patient's skin. In for example allergy testing, it is common practice in accordance with prior-art technique to apply an allergen-containing medium to an area of a patient's skin, whereupon a needle or similar means is made to pierce the skin in the area concerned. The medium thus is transferred by the needle into the skin, and the allergic reactions of the patient, if any, are determined visually. Since particularly in the case of allergy tests, as a rule several different media are to be transferred into the patient's skin when the above technique is used, the testing procedure is comparatively time-consuming. This involves problems, particularly if the patient is frightened of or experiences pain during the testing, which is not uncommon for example when children are tested. It is not either uncommon for the patient to retract his arm or other part of the body where the test is being performed, with the result that the different media applied on the arm are inadvertently mixed or drop off from the arm. In order to reduce these problems it has been suggested to inject a plurality of media essentially simultaneously into or through a patient's skin by employing different injection or introduction devices, said devices comprising a carrier adapted to be placed on the skin and supporting a plurality of needle means designed for injection of the media, said plurality of needle means arranged to be moved essentially simultaneously from a first position externally of the skin to a second position, in which said needle means have pierced or pene- trated the skin. US-A-5 335 670 shows one example of a device of this kind. According to the embodiment shown, this prior-art injector device does, however, require that the operator, for instance a physician, a nurse or other trained per- sonnel, uses both hands to hold the injector device and in a first stage moves the needle means into contact with the media in question and in a second stage brings the needle means into said second position, wherein the needles have pierced or penetrated the skin. US-A-5 179 959 and US-A-5 097 810 show additional examples of injector devices of this kind. According to the embodiments shown, also in these cases the operator needs to use at least one hand which he positions adjacent the carrier in order to force the needle means into said second position. In order to alleviate the fear in patients, for instance children, that are frightened of tests or injections, it is usually advantageous to divert the patient's attention from the injector device before administering the tests or injections. All prior-art devices referred to above comprise some kind of mechanical means by means of which pressure applied manually to a plate or similar element placed in the immediate vicinity of the points of skin penetration or piercing by the needle means, forces the needle means to pierce the patient's skin. In view of the fact that in testing or injecting, all prior-art devices must be actuated manually in the immediate vicinity of the points of skin penetration or piercing, it is, however, diffi- cult to divert the patient's attention from the injector device as the test or injection is being administered, which is a drawback. One object of the present invention thus is to provide an injector device that lends itself to remote control actuation. Another object of the present invention is to provide an injector device that is simple to use. These and other objects are achieved in accordance with the subject invention by means of an injector device as defined in the appended claims. Presently advantageous embodiments will be described in more detail in the following with reference to the accompanying drawings, wherein: Fig. 1 is a schematic view as seen from below of the carrier of an inventive injector device in accordance with a first embodiment. Fig. 2 is a schematic lateral sectional view taken on line A-A of Fig. 1, schematically illustrating a pressure generating means incorporated in the injector device . Fig. 3 is a schematic view from above of the carrier of Figs 1 and 2, but fitted with a fastening means. Fig. 4 is a schematic, broken lateral sectional view of an injector device in accordance with an alternative embodiment . Figs 5-7 are schematic views of the injector device of Fig. 4, shown in different operative positions. The injector device illustrated in Fig. 2 and generally designated by reference 1, comprises a carrier 2. In turn, the carrier 2 has a bottom 3 and a lid 4. A plurality of nozzles 5 are disposed in the bottom 3. A bore 6 extends inside each nozzle 5 and in accordance with the shown embodiment each bore is fitted with a guide sleeve 14. In addition, the carrier 2 of the injector device 1 comprises a plurality of needle means, generally referenced by numeral 7, each one of which comprises a needle 8 which extends inside the guide sleeve 14 in the bore 6 and which is connected to a spacer means 9. In addition, the carrier 2 of the injector device 1 is fitted with at least one membrane 10 and in accordance with the shown embodiment the membrane is attached, in an area around each spacer means, to spacer plates 11, 12 and 13 disposed intermediate the bottom 3 and the lid 4. In accordance with the shown embodiment the spacer means 9 are secured to the membrane 10, at a lower part thereof as seen in Fig. 2, for instance by means of glue. A chamber 15 is formed inside the carrier at the upper face of the membrane 10 as seen in Fig. 2, in the area of inter- connection between the respective needle means 7 and the membrane 10. Via channels 16 (see Fig. 3) in the carrier, the chambers 15 are sealingly connectable to a pressure generating means, referenced generally by numeral 17 (see Fig. 2). As in the embodiment illustrated in Fig 2, the pressure generating means could comprise a dosage means having a function essentially identical to equivalent means in syringes, but it is easily understood that the pressure generating means 17 could have any configuration designed to cause pressure to be exerted on the membrane 10. Preferably, the pressure generating means 17 comprises an actuator 18, such as the dosage means mentioned above, which preferably is located spaced from the carrier 2 for reasons to be explained further on. As appears from Fig. 2, the actuator 18 is connectable to the carrier 2 via a tube 19, the extension of which is such as to allow the actuator 18 to be located remote from the carrier 2. In accordance with the shown embodiment, the tube 19 is sealingly connectable to a nipple 20 which in turn, via a seal 21, is connected to a branch- off means 22 which is connected to the channels 16 in the carrier 2 via a seal 21' . As appears from Fig. 2, the nipple 20, the branch- off means 22, the bottom 3, the lid 4 and the spacer plates 11, 12 and 13 are secured to one another by fasteners 23. The chambers 15 and the channels 16 above the membrane 10 are sealingly connectable to the pressure generating means 17 and are sealed from an area 24 located around the respective needle means 7 in the carrier 2 below the membrane 10, as seen in Fig. 2. Each area 24 communicates in accordance with the shown embodiment with the atmosphere externally of the carrier 2 via an opening 25. As appears from the left-hand part of Fig. 2, in accordance with a first embodiment the injection device comprises a layer 26 which is penetrable by the needles 8. The layer 26 is arranged to be positioned intermediate the carrier 2 and the patient's skin 27, and preferably it is attached to the carrier 2. The layer 26 carries one or several media to be injected into or through the skin 27. The injector device 1 in accordance with Figs 1-3 functions as will be described in the following. In an initial stage, the needles 8 of the needle means 7 are in a protected position inside the carrier 2, as shown by continuous lines in Fig. 2. The needle means 7 could be moved to the initial position illustrated in Fig. 2 in continuous lines by application, through the agency of the operator, of a negative pressure on the membrane 10 with the aid of the pressure generating means 17. Alternatively, this initial position may be obtained by biasing means (not shown) , such as compression springs arranged to bias the needles means 7 and/or the membrane to the initial position. The carrier 2 is then placed against the skin of a patient in the area where the test/injections is/are to be carried out. For instance, the carrier 2 may be held manually in position in this area but preferably some kind of fastening means is employed to attach the carrier 2 to the patient's skin. Fig. 3 illustrates one example of such fastening means, which in this case are configured as fastening straps of similar construction to those used as watchstraps. In accordance with this embodiment the carrier 2 is arranged to be attached with the aid of the fastening straps to for example an arm or a leg of a patient. It will be appreciated that said fastening means could be configured differently from that illustrated in Fig. 3, for instance as straps fitted with Velcro tape to attach the carrier to the patient's skin. Once the carrier 2 is placed on the patient' s skin the pressure generating means 17 is actuated to produce a pressure which essentially momentarily affects the respective needle means via the membrane 10 for displace- ment of said means from the above-mentioned initial position to a second position, in which the needle means have pierced the layer 26 and penetrated into or through the skin 27 of e.g. an arm 28. This second position is illustrated in broken lines in Fig. 2 as regards the needle means 7 and the membrane 10. When moving to said second position each needle 8 carries medium from the layer 26 into or through the skin 27. It is particularly preferable to provide the layer 26 with different media in the area that is penetrated by the needle tips. This allows different media to be introduced into the patient by different needle means, which often is preferable in allergy testing. When the injection of the medium or media into or through the skin 27 is completed, the carrier 2 is removed from the patient. Preferably, the needles are retracted from the skin 27 prior to removal of the carrier 2 and are placed e.g. in the above-mentioned initial position. The needles may be moved to this position, for instance by exposing the membrane 10 to a negative pressure generated by said pressure generating means 17 or by means of said biasing means, after removal of the positive pressure generated by the pressure generating means 17, for instance by communicating the tube 19, the channels 16 or the chambers 15 with the sur- rounding atmosphere. Upon displacement of the needle means from the initial position to the second position the movement of each needle 8 is guided by the bore 6 and the guide sleeve 14 received therein. The movement of the membrane 10 from the initial position to said second position is facilitated by the respective areas 24 being vented by the respective openings 25. In the initial position shown in continuous lines in Fig. 2, the spacer means 9 are spaced a distance s from the bottom 3. In said second position, illustrated in broken lines, the spacer means 9 have been displaced into contact with the upper part of the bottom 3 as seen in Fig. 2, said upper part serving as an abutment face to the spacer means 9. By varying the distance s between the spacer means 9 and the abutment means of the bottom 3, the depth of penetration of the needle means 7 of an injector device may be set. According to the above embodiment a layer carrying one or several media is interposed between the patient' s skin and the carrier 2. The layer 26 may for example be impregnated with the desired media in patches adjacent the needles 8, or else receive these media in the form of drops on its surface. According to one alternative, illustrated by the embodiment at the right-hand side of Fig. 2, one or several media are contained in spaces 29 which are located in the areas of the needle tips of the respective needle means 7, or in areas through which the needle tips of the respective needle means 7 pass when moving from the initial position to said second position. The medium contained in the spaces 29 is transferred by the needle 8 into or through the patient's skin in a manner similar to that when the layer 26 is used. In accordance with one embodiment of the invention (not shown) , a medium dispensing apparatus is used to place said medium or media in the spaces 29. The medium dispensing apparatus could comprise for instance at least one pipetting means. Preferably, a plurality of pipetting means are mounted in a frame in such a manner that they are spaced apart by a distance matching the distance between the spaces 29 of the injector device. In accordance with this embodiment an injector device is moved to the frame and placed in such a position that each space 29 is turned towards the mouth of a pipetting means whereupon the pipetting operation is carried out such that the pipetting means ensure that the medium or media is/are introduced into the spaces 29, preferably essentially simultaneously. According to the above embodiments the spacer means 9 are connected with the membrane 10. It should be appreciated, however, that in accordance with an alternative embodiment the needle means 7 and the membrane 10, in an initial position or first position, may be spaced apart but that nonetheless the membrane 10 in accordance with this embodiment is arranged to affect the needle means 7 in order to produce the injecting movement of the needle means 7. In other words, the needle means 7 should be arranged so as to be actuated by the membrane 10. Figs 4-7 illustrate the mode of operation of an alternative embodiment of an injector device. In Figs 4-7 components similar to those illustrated in Figs 1-3 have received like numeral references with the addition of the prime sign. The needle means 7' shown in Fig. 4 comprises spacer means 9' in the form of a receptacle presenting a cavity 40 in its face turned towards the membrane 10' . The needle means 7' comprises a needle 8' having a bore 41 therein which communicates the cavity 40 with the tip of the needle 8' . Initially, the cavity 40 of Fig. 4 is not filled with medium. By actuation of a pressure generating means the needle means 7' may be shifted from the position shown in Fig. 4 to the position shown in Fig. 5 in continuous lines, in which position the tip of the needle 8' has penetrated into a container 42 filled with the desired medium. In this position, the membrane 10' sealingly abuts against the spacer means 9' in the area around the cavity 40. This may be achieved for example by attaching, e.g. by means of glue, the spacer means 9' to the mem- brane 10' in the area of abutment. Alternatively, the sealing-abutment feature is obtained in this second position may by means of the pressure between the mem- brane 10' and the spacer means 9' . When the pressure exerted on the membrane 10' by the pressure generating means is increased, the membrane 10' may be moved into the cavity 40, for example to the position shown in broken lines in Fig. 5. When the membrane 10' is moved into the cavity 40, the atmosphere present inside the cavity 40 is forced out of the cavity 40 and out of the needle 8' and into the container 42. As the pressure applied on the membrane 10' by the pressure generating means is subsequently reduced, the membrane 10' will be moved, first to the position illustrated in Fig. 5 in continuous lines, wherein suction is generated and the needle and preferably also the cavity 40 therefore are filled with the medium. When the pressure applied on the membrane 10' by the pressure generating means is reduced further, the membrane 10' is then moved to the position illustrated in Fig. 6. The carrier 2' is then applied on the skin 27' of a patient, whereupon renewed pressure application on the membrane 10' results in movement of the needle means 7' to the position illustrated in Fig. 7 in which it extends through the skin 27'. Additional pressure increase causes the membrane 10' to be moved into the cavity 40 again, the medium contained therein then being forced out of the cavity 40 and the needle 8' and transferred into the patient. According to this embodiment, the injector device thus creates a medium suction and emptying movement when the membrane 10' is being moved respectively into and out of the cavity 40. It is apparent from the above that the described injector device may be manufactured as a throw-away unit, in which case it preferably is made from plastics, or as a re-useable unit, and that it may be sterilised in some suitable manner prior to use. The injector device in accordance with the invention may, as already stated, be used for allergy testing but it should be appreciated that it could equally well be used for vaccine injections and the like. It should also be apparent that the embodiment of Figs 4-7 could be equipped with nozzles having a function similar to that of the nozzles 5 illustrated in Figs 1-3. Preferably, the carrier 2 and 2' , and as the case may be these nozzles, are configured to allow the carrier and/or the nozzle to abut directly or via said layer against the skin in the area where the individual needle means is to pierce the skin. It is naturally preferable to arrange for such abutment to take place simultaneously in all skin areas to be pierced by the needles. This arrangement is facilitated by the nozzles, since they project from the carrier in the area of each individual nozzle and since in accordance with a preferred embodiment they present a comparatively small area of abutment against the skin or said layer, a feature which allows the nozzles to be pressed against the skin directly or via said layer while the skin in consequence thereof as the need arises may be depressed resiliently inwards in the area of one or several nozzles in order to allow all nozzles to abut against the skin before the associated nozzle means pierces the skin. The carrier could also be configured for and/or be adaptable to the area of the skin of the patient where the test/injections are to be administered. For example, the carrier could have an arcuate extension, at least on the face that is to be turned towards the skin area, in order to facilitate the abutment, and could for instance have an arcuate shape adapted to fit the arcuate shape of the patient's arm or leg. Owing to the inventive device an essentially instantaneous displacement of the needle means 7; 7' into (as also out of) the skin 27; 27' is obtained. As described in the introduction, this is an advantage over the method involving several successive injections of media into or through the patient's skin, particularly in the case of patients that are frightened of the process of medium injection. Owing to the possibility of operating the pressure generating device 17 from a distance, away from the carrier 2; 2', the operator need not use his hands in the area of the carrier 2; 2' to administer the injection of the medium. This does, obviously, make the operator's task easier but it is advantageous also in the case of injection of media into frightened patients, since the inventive device makes it easier to divert the patient's attention from the carrier 2; 2' as a preliminary to administering the injection than in the case of devices configured in accordance with prior-art techniques. For instance, the operator may hide the pressure generating device 17 behind his back, thus preventing the patient from seeing when the pressure generation that causes the injection takes place. The inventive injector device ensures that essentially identical piercing pressure is applied on each needle means, which is important to achieve high accuracy and a high degree of safety with respect of the injection of the medium. In addition, all needle means 7; 7' are displaced over a distance of equal length when moved from said first initial position to said second position, which also contributes to the excellent medium injection results. In consequence, the inventive device is simple and safe to use. It goes without saying that some deviations may be made from the described embodiments. For instance, the carrier could, in accordance with an alternative embodiment, be configured as or form part of a cuff that could be applied for instance about a patient's arm or leg. All varieties and modifications that are comprised by the basic inventive idea should be regarded to be within the scope of the invention as defined in the appended claims.

Claims: CLAIMS 1. An injector device (1) for essentially simultaneous introduction of one or several media into or through a patient's skin (27; 27'), said device (1) comprising a carrier (2; 2') arranged to be applied on the skin (27; 27') and supporting a plurality of needle means (7; 7') intended for injection of the media, said plurality of needle means (7; 7') arranged to be moved essentially simultaneously from a first position externally of the skin (27; 27') to a second position in which said needle means have pierced or penetrated through the skin (27; 27'), c h a r a c t e r i s e d in that the carrier (2; 2') is formed with at least one membrane (10; 10'), that the needle means (7; 7') are arranged to be actuated by said membrane (10; 10'), and in that the device (1) comprises a pressure generating means (17) which is arranged to affect the membrane (10; 10' ) by exerting pressure thereon to move said needle means (7; 7') between said first and second positions. 2. An injector device as claimed in claim 1, c h a r a c t e r i s e d in that the pressure generating means (17) comprises an actuator (18) for initiating said needle means movement, said actuator (18) being spaced from the carrier (2;, 2') to allow remote control of said device (1) . 3. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that the device (1) comprises at least one fastener (36) by means of which the carrier (2; 2') is arranged to be attached to the patient. 4. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that the tips of the respective needle means (7; 7') are pro- tected by the carrier (2; 2') in said first position, and in that the needle means (7; 7') are disposed in respective bores (6, 14) in said carrier (7; 7'), said bores (6, 14) guiding the movement of the associated needle means (7; 7') between said first and said second positions . 5. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that the needle means (7; 7') are attached to one side of the membrane (10; 10' ) , and in that on the opposite side of the membrane, in the area of interconnection between each individual needle means (7; 7') and said membrane (10; 10') a chamber (15: 15') is provided, said chamber arranged to be sealingly connectable to said pressure generating means (17) via at least one channel (16) . 6. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that a space (29) for holding the medium is provided in the area of the tip of the individual needle means (7; 7') or in the area through which passes the tip of the individual needle means (7; 7') when moving from said first to said second positions. 7. An injector device (1) as claimed in claim 6, c h a r a c t e r i s e d in that it comprises a medium dispensing device, preferably formed with at least one pipetting means and arranged to position said medium or media in the spaces (29) . 8. An injector device (1) as claimed in claim 7, c h a r a c t e r i s e d in that the medium dispensing device comprises a plurality of pipetting means arranged so as to be spaced apart by a distance matching the distance between the spaces (29) . 9. An injector device (1) as claimed in any one of claims 1-5, c h a r a c t e r i s e d in that the device (1) comprises at least one layer (26) which is penetrable by the needle means (7; 7'), said layer (26) being inserted between the carrier (2; 2') and the patient's skin (7; 7') and preferably being attached to the carrier (2; 2'), and in that the layer (26) is provided with said medium in an area through which passes the tip of at least one needle means (7; 7') upon movement of the latter to said second position. 10. An injector device as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that each needle means (7; 7') is formed with a spacer means (9; 9') adjacent the membrane (10; 10'), that the carrier (2; 2' ) has at least one abutment means (3; 3' ) , that in said first position, the spacer means (9; 9') is spaced from the abutment means (3; 3' ) , and in that said spacer means (9; 9') is arranged to come into contact with the abutment means (3; 3') in said second position, the distance between said spacer means (9; 9') and the abutment means (3; 3') in said first position determining the depth of penetration of said needle means (7; 7'). 11. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that each needle means (7; 7') comprises a receptacle formed with a cavity (40) on its side facing the membrane (10; 10'), that the membrane (10; 10') is arranged to sealing- ly abut against the receptacle in the area around the cavity (40) , that a channel (41) passes through each needle means (7; 7') to interconnect the cavity (40) and the needle means tip, and in that the membrane (10; 10'), when actuated by said pressure generating means (17), is arranged to be moved into and out of said cavity (40) for the purpose of producing a suction and/or emptying movement with respect to said medium, at least in said channel (41) . 12. An injector device (1) as claimed in claim 10 and 11, c h a r a c t e r i s e d in that the spacer means (9; 9') is formed with said receptacle, and in that the membrane (10; 10'), following displacement of said spacer means (9; 9') to said second position into contact with said abutment means (3; 3'), is arranged to be moved into said cavity (40) . 13. An injector device (1) as claimed in any one of the preceding claims, c h a r a c t e r i s e d in that the device (1) comprises means arranged to facilitate the abutment against the skin (27; 27') by said device (1) in all areas where the needle means (7; 7') are to pierce the skin (27; 27' ) . 14. An injector device (1) as claimed in claim 13, c h a r a c t e r i s e d in that said means comprises nozzles (5) projecting from the carrier (2) and disposed adjacent said needle means (7; 7').

Inventors: NAENFELDT KAJSA, SIGURDSSON PER-ARNE, NAENFELDT, KAJSA, SIGURDSSON, PER-ARNE
Applicants: NAENFELDT KAJSA, SIGURDSSON PER ARNE, NAENFELDT, KAJSA, SIGURDSSON, PER-ARNE
Application year: 1997
Main classification: A61B17
IPC codes: A61B17, A61M5