JP2003507094A - Injection means - Google Patents

Abstract

(57) [Summary] The injection device has a small-mass needle that, when struck by a fast-moving block, is very quickly and easily accelerated to high speeds, causing pain in penetration. Decrease. And then, when the needle penetrates the skin, the substance is injected.

Description

Description: FIELD OF THE INVENTION [0001] The present invention relates to the use of, for example, drugs, vaccines, fluorescent or magnetic materials inside surfaces such as the skin of humans, animals or other organisms. And devices for delivering substances such as dyes. The substance is, for example, a solid, a specific fluid,
Or it may be a paste. Conventionally, many such devices have been proposed. Simple hypodermic syringes are the most well-known, although other mechanical combinations are well known, such as, for example, manually operated auto-injectors. [0003] Mechanically actuated devices have also been proposed to facilitate injection. This allows high-speed injection to reduce pain and bruises and bleeding caused by the injection. [0004] US Pat. No. 5,681,283 discloses the use of a system in which the needle is injected at a higher rate into the skin using a resilient band with the intent of making a less painful injection. Also, US Pat.
A pneumatically actuated self-rotating cassette with multiple stylets is disclosed to reduce the pain of injection. [0005] We have invented an improved apparatus and method for injecting a substance into a surface that facilitates faster use. The invention comprises a needle, a container for the substance to be injected, means for pouring the substance from the container to the tip of the needle, driving the needle through a surface and into it. An apparatus for injecting the substance into a surface comprising means for delivering the substance is provided. The driving means includes a block slidably provided in the conduit. The block is accelerated by a controlled force to strike the needle glulam, thereby causing acceleration of the needle to drive the needle into a surface. [0007] Preferably, there is a joint between the needle and the container, the joint being sufficiently flexible such that the needle penetrates the skin without breaking the joint. In hypodermic syringes and other devices, the needle is attached directly to the container for the substance to be injected. The needle and the container then move as a unit when the needle penetrates a surface. [0008] However, when a higher injection speed is used, the needle, the container and the substance to be injected are accelerated to the desired speed and the frictional force against the injection by the surface or the stop mechanism is increased. Either, enough force must be applied to stop them. The greater their mass, the more power and energy is required, and the more pain, scarring, bleeding, etc. is expected. In addition, the driving means has a larger mass and is more robust.
ust) and the weight must be larger. And the noise during the operation is larger, and the exhaustion and the like must be larger. The present invention minimizes the driving mass, thereby reducing or overcoming the above problems. If the mass of the fluid to be injected is small enough, the reservoir for said fluid will:
The needle and the reservoir can be combined with the needle so that they are accelerated as a unit, the volume of the fluid should be less than 1 ml and its mass should be less than 1 gram. [0010] Preferably, the mass of the needle holder (including the fluid reservoir, if included), ie the mass of the needle and its associated moving parts, is from 0.01 to 5.
Grams, more preferably 0.1 to 3 grams, and most preferably 0.1 to 3 grams.
2 to 0.6 grams (typical mass is about 0.6 grams). This means
It also means that the needle and other components connected to it have less kinetic energy and reduce the risk of bleeding and the like. This differs from other injection techniques, such as, for example, tranquillising darts, where the needle contains the substance to be injected when the needle penetrates the surface and its formation. It is fixed and directly connected to the chamber. [0011] Preferably, the mass of the block is 0.8 to 3 times, more preferably 1 to 2 times, the mass of the needle holder. The present invention can achieve very fast acceleration of the needle, the acceleration of the needle being preferably between 1 and 20000 g. [0012] Under these high acceleration and / or high speed conditions, it is important that the needle move very linearly along its axis, minimizing any lateral or longitudinal movement or bending. It is. In one embodiment of the invention, the block moves very linearly along its axis, hitting the needle glue directly in front of the central part. Also, the needle glue preferably limits lateral or longitudinal movement, which also minimizes bending. [0013] The driving means may include one or more leaf springs and a stop arrangement, or a bistable spring, or an arrangement of diaphragms. The needle drive means may include a mechanically hydraulic, pneumatic, or electromechanically driven drive mechanism. The preferred drive means is pneumatically actuated and is movable within said conduit such that the application of a fluid force at one end of the conduit produces, for example, a pulse of gas, such as air. Is provided. The wave of the gas propels the block in the conduit at a reduced speed, so that the block strikes the end piece that is connected to the end of the needle. Preferably, the block is allowed to return to its original position by reducing the pressure in the conduit. [0015] Preferably, said block is arranged so that its end contacts a source of air waves to act as a seal, and is held in place by the pneumatic pressure created behind it. When the release mechanism is activated, the block is free to move,
Propelled along the conduit by air pressure. The preferred seal is tapered at the end and conforms to the corresponding shape at the end of the tube in connection with the pneumatic source so that it forms a solid seal. The end of the block acts as a plug valve, forming a tight fit and being held in place by frictional forces. To act, the block is given a small push or light push to overcome frictional forces, so that the block moves along the conduit. The device may be provided in place for use with the block, such that air pressure is created behind the block for release. The end piece that is struck appropriately reinforces the end of the needle, if necessary.
It can also be a terminating component, or a component attached to the needle, or a forming part of the needle. The terminating piece generally, though not necessarily, has a flat terminus that is struck to facilitate operation. Suitable means for applying the fluid force include a hand held bellows, a pre-compressed gas, a piston with a spring return or motorized means. The bellows:
For example, forming a sealed rubber chamber connected to the conduit. Other means of operation use pen-type injectors, which are convenient to carry, and are used as needed. They can be a source of compressed gas that produces a wave of gas. The compressed gas is, for example, a gas such as carbon dioxide or air. The fluid force is created, for example, by the generation of a gas by evaporation of water or an organic liquid, such as by an electric heater. The gas then propels the block along the conduit. In another embodiment, there is a decrease in pressure in the conduit below the block in the direction the block moves. That is, a partial vacuum is formed, and this reduced pressure drives the block. The block is then sucked along the conduit. The method of using reduced pressure is used on its own or, as described above, either continuously or simultaneously, with the application of fluid force. In a preferred embodiment of the present invention, the needle contacts the skin with the needle,
For example, as described above, apply a blow to the needle so that the needle penetrates to a controlled distance inside the skin, and then guide the needle to the desired depth. Optionally, one step at a time is introduced into the skin by adding another sip or puffs. For example, the needle is guided inside the skin until it contacts the bone, and then, for example,
A puff is applied to the needle to inject it into the bone marrow to guide the needle into the bone. If more than one blow is required, this may be performed as described above, and / or more than one block may have its plurality of
(end piece) is provided in the conduit so as to strongly hit the end piece. The needle and the block are both connected separately, such that they are alternately slidable so as to be propelled along a conduit, and when the needle enters the skin and stops. The block hits the end of the needle continuously so that there is a double hit. That is, the overstrike refers to the impact when the needle enters the skin while striking the skin, and then when the block strikes the end of the needle to further advance the needle. In another embodiment, a valve and port arrangement is used with a compressed gas to drive the block toward the needle glue, as is well known in the aerodynamic arts. . When the block arrives at the end of its travel, the valve vents the forward driving pressure and applies pressure in the opposite direction to the block. The reciprocation is then repeated as required. In another embodiment, a portion of the momentum of the block is transmitted to the syringe plunger to create a pressure to inject an amount of the substance to be injected into the skin. If a rapid series of injections were required, for example, if the needle had penetrated a small distance into the skin, the motorized means would generate a wave of gas and a subsequent reversal of pressure. Used for In one embodiment of the invention, the substance to be injected is contained in a reservoir fluidly connected to the needle, and the needle is moved without accelerating the reservoir. , Having means for accelerating independently. This means that the mass to be accelerated is smaller,
This means that the needle can be easily accelerated and stopped. The supply of the substance to the needle is discontinuous, such that the needle is synchronized with a time just below the skin so that the substance is continuously infused into the patient in small volumes. . The needle is separated from and adjacent to the syringe containing the substance to be delivered, one end of which is flexibly connected to the end of the syringe, for example by means of a flexible tube or the swirl length of the needle. Is done. Thus, the rapid movement of the needle is not meaninglessly prohibited by the connection with the syringe. The needle is guided by the driving means until it has penetrated to the required depth. The syringe is then operated such that the substance contained therein is injected into the interior of the surface via the needle. In another embodiment, the syringe is struck by a piston that is operated in the usual manner, with a needle protruding from its end, and a driving means protruding from the piston and guiding the needle into the surface. And a connecting means between the syringe and the needle, the substance in the syringe being able to pass from the syringe through the needle as the piston is pushed. In use, the needle is placed against a surface and the end of the extension is struck as described above to guide the needle into the surface. And then, when the needle is guided to the required depth, the piston is pushed to inject the substance in the syringe into the interior of the surface. Preferably, the needle is adapted to guide it into the skin to the required depth,
One or more impacts are applied to its end to guide it into the user's skin. The substance to be delivered is then poured through the needle. Optionally, fit around the needle to assist in positioning and positioning the needle, hold the needle accurately on the survey line during the injection, and avoid any risk of the needle bending. A reducing needle guide is provided. A feature of the present invention is that the mass that must be accelerated at a high speed is much smaller than other techniques for propelling the needle with low energy, and stopping the needle is said other technique. Is much easier than that. The present invention provides for
Very high accelerations of up to 00 g can easily be achieved by simple means. For example, the required air pressure is obtained by blowing the conduit. The needle used has been found to be dull. Also, at least for some applications, blunt needles, i.e., needles with round or conical tips, and needles with less sharp or less sharp surfaces compared to typical hypodermic syringes or lancets It has been discovered that such a structure can be used and can cause less capillary severing and bleeding. This is thought to be because, when driven at the speed of the present invention, the blunt needle pushes away from skin components, such as capillaries and cells, rather than cutting them. Because,
If you used sharper needles, cut them. This reduces the risk and extent of scarring and the possible formation of fibrils and the like. For people like hemophilia etc. this is very beneficial. This advantage was surprising, and penetrating the skin with a blunt needle was considered difficult, painful, and would cause tissue damage if the skin was not cut. Was against. Preferably, said needle is hollow with at least one hole in which the wick is connected immediately adjacent its tip so that the injection is made at any depth below 1 mm of the skin surface . The needle has a smooth, tapered, rounded, essentially non-sharp edge or blade, or a chamfered edge, or essentially uncut tip with a surface. Optionally, the needle has a conical or rounded point, and a wick is connected to its exterior such that, in use, the substance is delivered to the skin surface. Or there are more grooves. And when the needle is inserted into the skin, the one or more grooves are essentially closed to prevent the intrusion of extraneous material or tissue into its core. ing. And, when fluid pressure is applied from the wick to the exterior, the area of the one or more grooves increases such that the flow of fluid material is greater. The one or more grooves are straight and parallel to the axis of the needle;
A movable valve that tilts at an angle to its axis, is helical in shape, or closes like a valve when external pressure is applied to the needle and opens like a valve when internal pressure is applied They are arranged as specified. The present invention is particularly useful for use in high speed injection methods, for example, where the needle has a speed of 1 meter to 100 meters per second to penetrate the skin and deliver material thereto. . Preferably, the driving means moves the needle at a speed of 5 to 50 meters per second.
More preferably, it is driven at a speed of 6 to 35 meters per second, or at a speed of 10 to 20 meters (for example, 15 meters). For people who need to inject frequently, such as diabetics who need to inject insulin regularly, reducing scars and bleeding is very beneficial,
The invention applies in particular to use for such people. After injection, the needle is withdrawn from the surface, at which time it has been discovered that in at least some applications, relatively slow withdrawal of the needle can reduce the risk of skin scarring. In another application, needle withdrawal is improved by rapid reversal acceleration of the needle. This is achieved, for example, by the release of a compressed spring or the flipping action of the moving block. As the block withdraws, a connection is made between the needle and the block to withdraw from the surface on which the needle is being injected. This feature is particularly beneficial in applications such as injection through a fingernail. With conventional syringes, it is difficult to remove the pliers that have to be used, for example, to pull out the needle when the needle gets stuck in the nail. As used for infusion of fluids, the device of the invention can be used for aspiration. The present invention will be described by the following examples, but is not limited to the examples. The tube and pneumatic drive weighs the block up to 0.4 g at a speed of 5-15 meters per second.
Used to accelerate at an acceleration of. A needle glue weighing 0.2 g is adjacent to the skin to strike the tip of the rounded needle. The needle includes a side hole adjacent to the tip and is capable of delivering a small amount of sterile saline to the skin without pain and being driven up to 10 mm into the skin of the arm, causing bleeding and Leaves no scars. For comparison, an injection device was tested that fires a 29 gauge bevel tip hypodermic syringe at a rate of 4 meters per second into the skin of the arm to a depth of 11 mm. There was significant pain and some bleeding after withdrawing the needle, and the scar that had spread around the penetration did not disappear after 5 days. Referring to FIG. 1, the syringe (10) comprises a piston (1) provided inside which is pushed by a handle (2). There is an outlet (4) from the syringe, and when the piston (1) is pushed, the substance in the body of the syringe (3) is pushed out through the outlet (4). One end of the needle (13) is attached to the outlet beside the Luer connector (5). The needle (13) is flexible and fixed with respect to the holder (6). The needle is zigzag or spiral, as shown in FIGS. 1a and 1b. The striker plate (8) is mounted on the holder (6), is the terminal part of the needle (13) and is slidably mounted in the conduit (9). Within said conduit is a block (20). The end of the conduit (9) allows forced air to enter the conduit and the block (20)
To strike the plate (8), it is coupled to a fluid pump or the like so that it can be propelled along said conduit (9). Due to the reversal of the direction of the air in the conduit, the block (20) is sucked towards the end of the conduit. In use, the substance to be injected is placed in the syringe (10) and one or more of the blocks (20) are connected to the conduit (9) remote from the end of the needle (7). ) At the end. The end of the needle (7) is placed against the surface to be injected and one or more of the blocks (20) are moved along the conduit (9) to strike the plate (8). A wave of high pressure air is sent to the conduit (9) so as to propel at the required high speed (i.e., 1 meter per second or more). The needle is then driven inside the surface and an impact is created on the plate (8), the needle penetrating through the surface. When the needle penetrates the surface, the piston (1) in the syringe (10) is pushed and the substance in the syringe is injected into the surface. Referring to FIG. 2, the syringe (24) has a needle (27) attached to one end, said needle being close to the tip (27) outside the end seal (31) of the syringe. It has one or more openings. The needle further has a gap along a shaft (23) leading inside the terminal seal of the syringe. Thereby, the substance in the syringe can enter the needle. The extension (28) facing said needle (27) slidably and tightly passes through the piston (25) and terminates in a striker plate (29). The striker
The plate is located below in the conduit (30). The block of the conduit (30) is propelled by air to strike the plate (29). In use, the syringe is filled with the substance to be injected and the needle (27
) Are arranged in contact with the surface. One or more blocks are propelled along the conduit (30) in a manner similar to that described above with reference to FIG. 1 to move the striker plate (29) and the needle (27) inside the surface. Drive.
When the needle has penetrated the surface to the required depth, the piston (25) is pushed and the substance is injected inside the surface. It will be appreciated that all embodiments of the present invention can be modified to deliver many different substances into the skin. The substance is, for example, a traditional tattoo dye, a fashion dye, a drug, a substance for gene therapy, or a granular substance. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an embodiment of the present invention. FIG. 2 is another embodiment of the present invention. [Description of Signs] 1, 25 Piston 2 Handle 3, 10, 20, 24 Syringe 4 Outlet 5 Luer Connector 6 Holder 7, 13, 27 Needle 8, 29 Striker Plate 9, 30 Conduit 23 Shaft 28 Extension

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Claims (1)

Claims: 1. A needle, a container for the substance to be injected, means for adding the substance from the container to the tip of the needle, and driving the needle through the surface. Means for delivering the substance thereto; the driving means comprising a block slidably mounted in a conduit, the block for hitting the needle glue with a controlled force. Accelerated to
An apparatus for injecting a substance into a surface configured to cause acceleration of the needle to drive the glue of the needle into the surface. 2. The device of claim 1, wherein in use, a majority of the energy for penetrating the surface after contacting the surface is the momentum of the needle and the portion operating in connection therewith. And not from the continuing force of the drive means. 3. Apparatus according to claim 1, wherein said drive means is actuated pneumatically. 4. The device according to claim 1, further comprising stopping means incorporated in the driving means to stop the needle quickly. 5. The apparatus according to claim 4, wherein the driving means is arranged such that application of a pneumatic force or a spring at one end of the conduit causes the block to be propelled at a reduced speed along the conduit. A block slidably mounted within the conduit, wherein the block strikes a terminating piece that forms part of the needle or that is connected to a terminal end of the needle. 6. The apparatus of claim 6, further comprising means for generating a pulse of gas within the conduit that propels the block along the conduit. 7. Apparatus according to claim 5, wherein the end of the block is tapered and forms a plug valve at the end of the tube.
Attached to the end of the correspondingly shaped tube connected to a source of compressed air, the device includes means for moving the block away from the end of the tube. 8. The device according to claim 6, further comprising means for returning the block to its original position by depressurization inside the conduit. 9. The apparatus according to claim 8, comprising means for applying a plurality of pulsed impulses to said plate, and means for retracting said block behind said conduit between pulses. 10. The device according to claim 9 or 10, wherein the block and the needle are withdrawn from the surface as the block returns to its original position or withdraws along the conduit. Are joined together. 11. Apparatus according to any one of claims 3 to 10, wherein the means for propelling the block along the conduit comprises a hand bellow, a piston, and a return spring or pre-compressed. Gas or motor driven gas pump. 12. The device according to claim 3, wherein:
Means for reducing the pressure below the block in the direction in which the block moves so that a partial vacuum is formed. 13. The device according to claim 4, wherein the needles are blown each time to control the interior of the skin until the needles are guided to a desired depth. Means for applying a plurality of puffs to the needle to penetrate the distance. 14. The apparatus according to claim 13, comprising two or more blocks provided in the conduit such that, in use, a plurality of hits strikes a terminal portion thereof. 15. The device of claim 13, wherein the needle and the block are slidably coupled to each other while being slidable so as to be propelled together along the conduit. When the needle enters the skin and stops, the block persists and strikes the end of the needle. 16. The device according to any one of the preceding claims, wherein the supply of the substance to the needle is discontinuous. 17. The device according to any one of the preceding claims, wherein the needle is separated from and adjacent to a syringe containing a substance to be fluidly injected at one end of the needle, and the needle of the syringe. A flexible connection with the end, such that the rapid acceleration and movement of the needle is not meaninglessly prohibited by the connection with the syringe.
Be flexible enough. 18. The device according to claim 17, wherein the needle is coiled, looped, or zigzag. 19. A device according to any one of the preceding claims, wherein the end is struck by a piston attached to the needle projecting from the end and a drive means for guiding the needle into the surface. A syringe having the other end of the needle having an extension protruding from the piston; and means for coupling the two, wherein the substance in the syringe removes the needle from the syringe as the piston is depressurized. Can pass through. 20. Apparatus according to any one of claims 16 to 19, wherein a part of the momentum of the operating block comprises a pressure for injecting a certain amount of the substance to be injected into the skin. To cause it to be transmitted to the plunger of the syringe. 21. The device according to any one of the preceding claims, wherein the needle has a needle guide device which, when in use, has a limited longitudinal or lateral movement so that it can slide. 22. The device of claim 21, wherein the needle guidance device limits the vertical or horizontal movement of the needle to no more than +/− 2 °. 23. The device of claim 22, wherein the needle guidance device limits vertical or horizontal movement of the needle to no more than +/- 0.5 °. 24. The device of claim 21, wherein the needle guidance device limits vertical or horizontal movement of the needle to no more than +/- 0.1 °. 25. A device according to any one of the preceding claims, wherein in use 1 m per second to penetrate the skin and deliver the substance thereto.
Means for driving said needle at a speed from 100 to 100 meters per second. 26. The apparatus according to claim 25, wherein the needle driving means drives the needle within a range of 5 to 50 meters per second in use. 27. The apparatus according to claim 25, wherein the needle driving means drives the needle within a range of 10 to 20 meters per second. 28. The apparatus according to any one of the preceding claims, wherein the means for driving the needle accelerates the needle in use from 1 to 20000 g. 29. Any of the devices according to the preceding claims, wherein the mass of the fluid to be injected is less than 1 gram and the container for the fluid is integrated with the needle . 30. The device according to any one of the preceding claims, wherein the mass of the needle and the associated working part is between 0.01 and 5.0 grams. 31. The device according to any one of the preceding claims, wherein the mass of the needle and its associated working part is 0.1 to 3 grams. 32. The device according to any one of the preceding claims, wherein the mass of the needle and the associated working part is between 0.2 and 0.6 grams. 33. The apparatus according to any one of the preceding claims, wherein the mass of the block is 0.8 to 3 times the mass of the needle holder. 34. The apparatus according to claim 33, wherein the mass of the block is one to two times the mass of the holder of the needle. 36. A device as claimed in any one of the preceding claims, wherein the substance to be delivered is a natural, manual or mechanical pressure on the needle by a syringe or a compressible bag. Infused under. 37. Apparatus according to any one of the preceding claims, comprising means for repeating a cycle of needle insertion, substance delivery and needle withdrawal. 38. The apparatus of claim 37, wherein the infusion rate is between 1 and 50 per second. 39. The device according to any one of the preceding claims, wherein the needle is directly in contact with the core adjacent to the tip such that the injection is less than 1 mm deep below the skin surface. It is hollow with at least one opening to join. 40. Apparatus according to the preceding claim, wherein the needle has an essentially non-sharp edge, or a non-jagged, tapered, rounded blade, or a beveled edge or outer surface. Having an essentially uncut tip. 41. A device according to claim 41, wherein the needle has a conical or rounded needle tip, and further comprises a subcutaneous material for use and subsurface of the skin. There is one or more slots that couple the wick to its exterior so that it can be delivered, wherein the one or more slots do not allow any external material or tissue to enter the interior of the wick. So that it is closed tightly. 42. The apparatus of claim 41, wherein when one or more fluid pressures are applied externally from the core, the area of the one or more slots increases the flow of the fluid material. To increase. 43. The apparatus of claim 41, wherein the one or more slots are elongate, parallel to, and inclined at an angle to, an axis of the needle. It is helically shaped or arranged to define a movable flap that closes like a valve when external pressure is applied to the needle and opens like a valve when internal pressure is applied. 44. An apparatus for injecting a substance into a surface, as described above with reference to the figures. 45. Use of the device according to any one of the preceding claims,
How to deliver the substance.