Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
  • A61M2005/005—Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
  • A61M2005/2403—Ampoule inserted into the ampoule holder
  • A61M2005/2411—Ampoule inserted into the ampoule holder from the front
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
  • A61M2005/2485—Ampoule holder connected to rest of syringe
  • A61M2005/2492—Ampoule holder connected to rest of syringe via snap connection
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
  • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
  • A61M5/3007—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end

Definitions

• This invention relates to hypodermic injection systems, and more particularly to injection systems wherein the injectate is held in containers, and the system discharges the injectate from the containers.
• the invention finds particular use as a multi-channel injection system.
• hypodermic injection systems are widely used throughout the world today, both with respect to humans and with respect to animals. Moreover, there are many situations when multiple injections made simultaneously are either required or would be helpful.
• different materials can be injected (often referred to herein as "injectates") for protecting against a variety of diseases, for serving as components for a single disease, for providing added health benefits to humans or animals, such as by way of added vitamins, minerals, etc., or to provide improved characteristics, such as to cause cattle to provide more milk, to enhance their growth, or to deliver immunopharmaceutical compounds to inhibit the reproductive system in food producing animals, or a particular type of medical procedure in humans.
• An object of the present invention is to provide a hypodermic injection system for providing injectate from containers holding the injectate in an efficient and safe manner.
• An object of the present invention is to provide a hypodermic injection system for avoiding needle sticks in the person administering the injection.
• Another object of the present is to provide an injection system for simultaneously providing at least two injections, and further including means for preventing needle sticks to persons who are not supposed to be injected. It is yet another object of the present invention to provide an injection system wherein the injectate is held in cartridges having injection orifices through which the injectate passes and enters the desired body.
• Yet still another object of the present invention is to provide an injection system having biasing means for urging injectate from a cartridge into a body, and a loading station for energizing the biasing means in a fast and economical manner.
• Another object of the present invention is to provide a hypodermic injection system having a container holding member for holding injectate containers, the holding member with the container members being disposable after an injection without requiring any physical contact or handling of the disposable portion by the user.
• Another object of the present invention is to provide a hypodermic injection system for simultaneously injecting injectate from at least two cartridges, the cartridges being disposable after an injection without any physical contact or handling of the disposable portion by the user.
• a further object of the present invention is to provide a hypodermic injection system for injecting injectate from at least one cartridge, the cartridge(s) being held in position by a disposable front plate.
• Another object of the present invention is to provide a multi-cartridge injection system with one or more springs for applying pressure to the cartridges to dispense the injectate, and a latching apparatus for cocking and releasing the spring(s).
• Yet a further object of the present invention is to provide a multi-channel injection system wherein the injection means are provided in close proximity to enable multiple multi-channel injections safely and effectively.
• Another object of the present invention is to provide an injection cartridge, the cartridge having a dispensing end with an orifice or perforator through which the injectate can be dispensed, and a movable plunger in the cartridge which can be moved into the injectate-holding portion of the cartridge to effect the dispensing of the injectate.
• An additional object of the invention is to provide an injection cartridge for holding at least two components of an injection dosage.
• a further object of the present invention is to provide an injection system for a plurality of cartridges, the cartridges having plungers for dispensing the injection injectate in the cartridges, the injection system further having a carriage with rams for moving towards the plungers to drive the injectate from the cartridges, and means for resetting the carriage in a cocked position. It is yet another object of the present invention to provide a hypodermic injection system for dispensing injectate from at least one cartridge, the system having biasing means which is placed and held in the cocked position in accordance with a sensing signal indicating whether or not a cartridge is loaded in the system.
• a jet hypodermic injection system for holding at least one cartridge for holding a serum, a vaccine or other injectate.
• the cartridge preferably has a dispensing end with an end portion having a channel with an exit nozzle being an orifice.
• a plunger is provided in the cartridge, and an injectate is disposed between the plunger and the end portion.
• the end portion could alternatively have a perforator rather than an orifice for the exit nozzle.
• the system includes a housing having a disposable front end plate with holes having holding surfaces for holding the forward end of the cartridges.
• the housing houses a movable carriage with rams for moving the plungers through the respective cartridges.
• the carriage is movable between a set position and a dispensing position.
• One or more springs move or drive the carriage from its set position, wherein the springs are in a cocked position, to a dispensing position wherein the carriage carries the rams for moving the respective plungers through the cartridges to force injectate through the respective channels and exit nozzles into the body being injected.
• the spring(s) are held in a cocked position by a releasable latch, which could be a solenoid piston which is actuated when a cartridge sensor emits a signal to the solenoid according to whether a cartridge or cartridges are loaded in the housing.
• the spring(s) are preferably guided and positioned by movable rods which extend between the carriage and the rear part of the housing through which they extend.
• a fixed member on the rod(s) defines a shoulder for supporting one end of the s ⁇ ring(s); the other end of the spring(s) engages the inner part of the rear wall of the housing. As the carriage moves towards the set position, it moves the respective rods and compresses the spring(s) to their cocked position.
• the front plate for holding the respective cartridges is ⁇ jeetable or catapulted away from the injector after the cartridges have been used, and the plate with the spent cartridges are thereby disposed.
• the cam or other carriage resetting apparatus is moved from the final position to an initial position by means of a motor having a motor- driven tool designed for rotating the cam or other apparatus.
• a loading station can be provided for resetting the cams of one or more injection systems according to the invention, which is preferably done when new cartridge(s) are to be loaded in the system.
• Figure 4 is a pictorial view of the front end of the invention showing the center two cartridges having orifices loaded in the front end and the four outer cartridge locations having dummy loads;
• Figure 6 is a transparent pictorial view of a cartridge according to the invention
• Figure 7 is a cross-sectional view of the preferred embodiment of the energy storage part of the system shown in Figure 1;
• Figure 9 is a pictorial view of the rear portion of the embodiment shown in Figure 8.
• Figures 10-12 are schematic views of dispensing portions for a six-channel injection system according to the invention.
• FIGS. 1 and 2 a preferred embodiment of the invention is shown. These figures show a hypodermic injection system 1 having a housing 3 and a handle 5. Housing 3 includes a front end or plate 7 having an injection trigger 9 and a front end release trigger 11. Trigger 9 can be in the form of a rotatable lever, whereas trigger 11 can be a depressible button. System 1 is shown for delivering six simultaneous injections as described below, although the number can be from one to N (i.e., any number of injections).
• front end trigger 11 After an injection has been given from the cartridges loaded in system 1, the user actuates front end trigger 11 which withdraws locking members 17 which have entered grooves 19 in front plate 7, and which further releases the springs located in the mating holes at position 21 to exert a spring force urging front end 7 with cartridges 13 forwardly away from housing 3, to catapult these parts from housing 3 for disposal, such as into a container B designed to hold contaminated goods.
• Front plate 7 is shown in further detail in Figure 3. As explained earlier, front plate 7 is one of many possible devices for holding the injectate containers, such as cartridges 13.
• Front plate 7 includes an external front surface 23 and a rearwardly extending portion 25 into the opposite sides of which are provided grooves 19. Front plate 7 can be slid into place and grabbed by locking members 17 near the front of housing 3, which are received in grooves 19, these members 17 being withdrawn upon the actuation of trigger 11. Alternatively, locking slides or the like can be removably inserted into grooves 19 to lock front plate 7 to housing 3 (of which the front end forms a part), the front plate being ejectable from the remainder of housing 3 once the locking members 17 are removed from grooves 19. Front end 7 further has holes 29 with holding surfaces 31 for gripping the forward ends of cartridges 13 which are preferably press fit into holes 29 to hold the cartridges in place.
• the outer surfaces of cartridge 13 can have a high friction surface if necessary, to assure a firm grip.
• Guard rings 33 are provided around each of holes 29 in order to prevent the splashing of blood or of injectate as it flows through the exit nozzle of cartridge 13, particularly during the injection process.
• An additional splash ring 35 can also be provided, as shown in Figure 2, to add more protection against splashing.
• Front plate 7 or other holding members are disposable as explained above. In order to maintain the sterility of the front end, it is provided in a package for keeping the front end sterile. Sterile packaged cartridges can be filled at the site of the injection procedure, or they can be delivered already filled with the selected vaccines ready for insertion into front plate 7. Alternatively, the front end can be provided with cartridges previously inserted and filled with the proper dosage of the respective injectate to be contained therein, all of which would be provided in the sterile package of the front end in which they are being gripped. It should be noted that front end 7 could hold one cartridge, six as shown, or indeed any number of cartridges. For various practical reasons as discussed below, it is anticipated that no more than six injections would be simultaneously given.
• Orifice 35 could be replaced with a perforator, such as perforators on the order of 0.5 to 1.0 mm in length, as disclosed in U.S. patent application Serial No. 08/738,303, as shown as perforators 36 in Figure 5.
• perforators would allow for lower injection pressures and a reduction, if not the total elimination, in the amount of injectate fluid remaining on the surface following an injection.
• Experimental programs by the inventors have shown that perforators would sometime improve the efficacy and also reduce impact trauma to the patient.
• Figure 5 shows perforators 36 at the active channels, and dummy cartridges 37 at the inactive channels.
• Figure 6 shows an injectate container in its preferred form as cartridge 13.
• Cartridge 13 has an outer wall 38 and an inner wall 39 which defines a tube 41.
• Slidable into tube 41 is a plunger 43 with a seal at its outer circumference to prevent leakage out the back end and which can be made from an elastomeric material, such as a rubber-like compound, plastic or even glass, but with a rubber seal.
• Plunger 43 is dimensioned to engage inner wall 39 in a fluid-tight manner.
• Plunger 43 can have two wall-engaging cylindrical portions 45 (towards the front) and 47 (towards the rear) to further discourage leakage during an injection.
• Plunger 43 defines an injectate-holding portion 49 of cartridge 13, between plunger 43 and a forward part 51 of cartridge 13 having a channel 53 which terminates in orifice 35.
• the portion of cartridge 13 at its forward end has a smaller diameter than does the rearward part, and is preferably press fit into front plate 7 as explained earlier.
• the rear part of front plate 7 preferably engages a shoulder 55 when cartridge 13 is press fit into plate 7.
• Cartridge 13 could be filled on-site or could be filled off-site, depending on the circumstances. Furthermore, cartridges 13 could be preloaded into the holding member such as front plate 7 at the site where the system is to be used, or it can be done off-site. When done off-site, the cartridge could be filled and sent to the loading facility separately from the front plate, or they could be preloaded into the front plate (or other holding member) and provided in a sterile package.
• Cartridges 13 could be designed for lyophilized vaccine by providing two compartments that are separated by an easily rupturable seal, such as seals 56 shown in dotted lines.
• One compartment would contain the lyophilized vaccine, medication or serum, and the adjoining compartment would contain the correct amount of fluid for mixing it.
• Means could also be provided for rupturing the seal and mixing the ingredients together when a cartridge is inserted into front plate 7 or when the cartridge- laden plate is inserted into the injector.
• a means of mixing lyophilized vaccines in the cartridge at the time of injection is described in U.S. Patent No. 5,080,648.
• FIG. 7 is a cut-away view of system 1 without the handle or triggers discussed earlier.
• System 1 has housing 3 and end plate 7, as explained earlier. To avoid undue complexity in Figure 7, the means for ejecting or catapulting front plate 7 away from the injector are not shown.
• Housing 3 houses a carriage 57 which has extending from it rams or plunger rods 59.
• a set of three springs 61 (for each of the three cartridges shown, there being six cartridges and springs in system 1) extend around the set of drive rods 63, each of which having nuts or movable spring supports 65. Supports 65 are movable along threaded rods 63 to provide a means to adjust spring preload and, therefore, injection pressure.
• Figure 7 shows injection system 1 after an injection has been made.
• Carriage 57 is in its dispensed position, having been moved all the way to the right to the front of housing 3.
• Rams 60 have pushed plungers 43 to the forward end of cartridges 13 to discharge the injectate from the two active cartridges during the injection process.
• shaft 83 and cam 81 are rotated clockwise by a motor (as discussed below) causing roller 89 to roll across the periphery of cam 81 and move cam follower 85 and carriage 57 rearwardly to the left in Figure 7.
• the contour of cam 81 is configured to effect this movement as its radius increases at the point of contact with roller 89.
• rods 63 are forced to the left as well.
• trigger 9 In order to commence an injection with carriage assembly 57 in its set or cocked position and springs 61 in their cocked position as well, the user of system 1 actuates trigger 9. This action will either release a mechanical latch (not shown) or will provide a slight rotation to cam 81 to allow roller 89 to release as it moves onto the sharp drop off 87 of cam 81. Springs 61 drive rods 63 forwardly to move carriage assembly 57 forwardly, and thereby drive rams 60 against plungers 43 to force injectate through channels 51 of cartridges 13 and out through orifices 35 (or perforators 36). After the injection, the user actuates trigger 11, causing the catapulting of front plate 7 and cartridges 13 from the unit for disposal, such as into a barrel B.
• a motor and power source are included in handle 5 for resetting cam 81 to its initial position.
• a unit such as that in Figures 1 and 2 is portable, easy to use, and particularly easy to use for injections for large numbers of people or large numbers of animals.
• injector system 1 is small, lightweight and easy to handle, in some situations it might be advantageous to make the hypodermic injection system according to the invention even smaller and lighter, when masses of people or animals are being injected, such as where a health care worker administers hundreds or thousands of injections over the course of a day. Accordingly, the preferred embodiment shown in Figures 8 and 9 form another aspect of the present invention.
• FIG 8 shows two hypodermic injection systems 1 according to the invention, in this case without a handle.
• a loading station 101 is provided for putting the carriage in its set or cocked position, and for compressing or cocking the springs.
• housing 3 houses cam 81, springs 61, and injection chambers 88 for cartridges 13, as explained earlier.
• Loading station 101 has a series of walls defining compartments 103, 105 and 107 for each receiving an injection system 1.
• Each compartment 103, 105, 107 includes a drive mechanism 109 having a hexagonal shape for engaging a corresponding portion of cam axle 83.
• An enable button 111 is preferably provided so that when a system 1 is inserted in a compartment 103, 105, 107, button 11 is depressed and drive mechanism 109 rotates cam 81 to its loaded or injection ready position.
• the drive mechanism stops rotating upon the actuation of an internal disable switch which detects the correct amount of rotation.
• These injector positions could be sensed electronically rather than using the button switches as shown.
• the hand-held portion, system 1 of Figure 8 is then removed from station 101 for an injection to be made. The system is then reloaded and reset with loading station 101. While injection system 1 in Figure 8 has the same form (less the handle) as shown in Figure 1, in an actual commercial system, it will have a shape that is easily held by the user when giving an injection.
• Loading station 101 can be energized using the AC input 113 or a DC input 115.
• An on/off switch 117 is also provided.
• the power can be an AC grid or battery, or can use compressed gas, ignitable gas such as butane, hydraulic drive, or manual operation using a hand crank or a foot pedal.
• Systems 1 shown in Figures 8 and 9 can be easily moved when the injection procedures are completed. Load stations 101 need not be picked up by the health care worker when an injection is given. Loading station 101 and system 1 are only brought together when spring compression is needed, and this could even be done using a long speedometer-type cable connection instead of a direct contact interface as shown in Figures 8 and 9. Even though Figures 8 and 9 show DC and AC power inputs, manual loading is also possible in case of power failure or lack of power at a particular location.
• Figure 7 shows a spring for each cartridge, a single spring is also possible.
• Other means for providing pressure for dispensing injectate from the holding members are possible.
• Other springs besides wire springs could be used as well, including resilient plastic springs, elastomeric springs such as rubber or rubber-like materials, and possibly electro-magnetic fields.
• the cam system shown in Figure 7 has been found to be effective, other means for setting the system would also apply.
• there could be gearing systems, linear systems, such as those with linear gears, pawl and gear mechanisms, belts, rollers, and the like could be employed.
• the injectate containers have been shown as being rigid, but in some situations flexible plastic holders might be appropriate as well.
• FIG. 10 relate to a configuration analysis of the exit nozzles.
• the configuration of exit nozzles is particularly important with regard to multiple simultaneous injections which are given to a limb of a small child, wherein the available surface area needed to deliver an effective injection is limited.
• the injections In order to achieve this non-overlap condition, the injections must be delivered a certain minimum distance apart.
• the inventors have carried out a geometric analysis to determine the configuration of the exit nozzles that uses the least amount of surface area while still preventing overlap of the vaccines in the tissue.
• an analysis of the volume of tissue affected by an injection was required. Accordingly, a six-channel system with a delivery volume of 0.2 cc for each channel was assumed. However, it was also noted that the standard single-shot dose is actually 0.5 cc. It is possible that smaller doses from vaccine manufacturers may occur with multiple channel injections.
• the configurations considered by the inventors were rectangular, pentagonal with one orifice in the center, and hexagonal. Pathological observation by the inventors made during the course of a U.S.

Applications Claiming Priority (3)

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Citations (3)

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• 2000
  • 2000-03-21 WO PCT/US2000/007470 patent/WO2000056381A1/en not_active Application Discontinuation
  • 2000-03-21 EP EP00916577A patent/EP1171179A4/de not_active Withdrawn
  • 2000-03-21 JP JP2000606283A patent/JP2002539857A/ja active Pending
  • 2000-03-21 AP APAP/P/2001/002279A patent/AP2001002279A0/en unknown
  • 2000-03-21 AU AU37662/00A patent/AU3766200A/en not_active Abandoned
  • 2000-03-21 CA CA002368611A patent/CA2368611A1/en not_active Abandoned
  • 2000-03-21 BR BR0010769-7A patent/BR0010769A/pt not_active Application Discontinuation
  • 2000-03-21 MX MXPA01009531A patent/MXPA01009531A/es unknown
• 2001
  • 2001-09-03 ZA ZA200107275A patent/ZA200107275B/xx unknown

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