CN1277586C - Universal anti-infection protector for needle-free syringes - Google Patents

Abstract

A medical device for avoiding cross-contamination of patients or syringes, wherein a protective layer (14) is used in combination with other components (16) of a needleless syringe (18) to minimize or eliminate back splash contamination of the syringe.

Description

Universal anti-infection protector for needle-free syringes

Related patent applications

This application claims priority and benefit from two earlier applications, one of which is Russian Patent Application No. 99121141 filed on October 12, 1999, now known as Russian Patent No. 2152227; the other application is from 1999 The disclosure of Russian Patent Application No. 99124268, now Russian Patent No. 2152228, filed on November 23 with the Federal Institute of Industrial Property of the Russian Federation is hereby incorporated by reference.

                            

The present invention relates to injection devices, including injection devices for intradermal, subcutaneous and intramuscular injections.

Background of the Invention

The most effective way to prevent many diseases is mass vaccination. Since medical science has understood the principles of virus theory and its importance in the spread of disease, the need to interrupt the chain of transmission of a virus or bacterium from host to host has become very certain. There are many methods accepted by medical science to break this chain of transmission, as the situation requires. The most stringent protocols include sterilization, disinfection and sanitation of equipment using thermochemical and/or ionizing radiation.

Shielding is another common convention and can be as simple as creating a hypothetical shield where one side of the shield is kept clean and the other side is defined as being polluted. Any object that is transferred from the clean side of the boundary line to the contaminated side of the boundary line will not return to the clean side until it has been sterilized, sanitized, and disinfected. A typical example of such an agreement is in the field of medical surgery. The operating table surface is defined as this boundary. Any item that falls below the surface of the operating table is immediately qualified as contaminated. Items referred to here include surgical instruments or the surgeon's hands.

With needle injection devices, there are two common conventions that proceed from the premise that a used syringe is, by definition, contaminated. The first convention, commonly used in dentistry, is to use only syringes, and sometimes sterile needles, that are sterilized after each use. The second convention is more commonly used in general medicine in the United States and other developed countries. This is the single-use syringe and needle assembly. Because of its generally low production costs—less than $0.10 per syringe component—this engagement is well accepted.

On the other hand, jet injection systems continue to be characterized by their relatively high cost per syringe ($1.00 or more) as the injection portion of each used syringe is discarded. In addition, challenges exist in developing countries where there is a lack of knowledge about virus theory and/or a prevalent psychological preparedness to follow generally accepted practices in all aspects of health and hygiene. With the recognition of bloodborne pathogens of human immunodeficiency virus (HIV), hepatitis B, hepatitis C and other diseases in subjects, the need to follow the correct protocol becomes even more critical.

Jet injectors such as the Ped-O-Jet(R), Ammo-Jet(R) and similar mass campaign jet injectors have been incorporated into the healthcare system in the past. Apart from the complicated disassembly and sterilization process of these jet syringes, there is no guarantee against the transmission of blood-borne pathogens. These types of syringes fell out of favor in the mid and late 1980's when bodily fluids were determined to be readily transmissible from one patient to another in mass immunization campaigns.

To eliminate the possibility of transfer of pathogens carried by blood between individuals, single-use or partially single-use jetting syringes were developed. The Bio-Jet(R), J-Tip(R) and other jet injectors characterize this type of jet injector. Due to their high direct costs, general acceptance of these devices is limited, even in developed countries like the United States. A standard example of breaking the chain of contamination transmission has been brought to attention, which requires either making the syringe single-use or designing it so that it can be easily decontaminated. Currently, there is a steadily increasing risk of epidemics (AIDS, hepatitis, tuberculosis, and other blood-borne viral diseases) being passed from person to person through needleless injections.

A conventional needle-free injector includes: a basic design; a housing with an internal energy unit; a drug unit and a nozzle. The function of the energy unit is to pump the drug into the cavity under the plunger of the drug unit chamber and to expel the drug from the nozzle.

In the early stages of the development of needle-free injection, when no one-way valve was used as a control device to function in the drug chamber, one way to prevent foreign particles from entering the syringe nozzle was to use a sealed nozzle cap. Such nozzle caps are limited by filling the drug chamber with drug and cannot guarantee against contamination.

Another way to prevent contamination problems is to use disposable, low cost one-shot nozzle assemblies for jetting syringes. The nozzle assembly consists of a two-piece molding unit combined with a generally cylindrical nozzle body having a longitudinal central bore of predetermined diameter extending from the proximal end of the nozzle. end extending toward its distal end, terminating in the conical portion of the nozzle. A very small jet-forming hole, usually made at the apex of the conical portion of the central hole. A disadvantage of this device is its low efficiency (ie slow vaccination rate) due to the low flow rate due to the conical design. Furthermore, a plastic nozzle element also increases the cost of vaccination.

A typical jet injector design has additional disadvantages. Even if a protective cap is used in practice, there is the potential for transmission of infection from one person to another through reflection of fluid (blood, lymph, drug) from the skin surface (“splashback”) during injection sex. The protective cap may be a one shot protective cap including an injection nozzle. One function of this device is to avoid multiple uses of a protective cap on a nozzle. This object is achieved by removing, replacing and/or destroying the protective cap at a later stage of the injection. However, cross-contamination continues to be unpredictable because during the injection phase, contaminated material can be transferred through the nozzle to the interior of the syringe, for example into the cavity, and transferred to a new patient through a new protective cap and nozzle.

Achieving the minimum safety requirements to avoid cross-contamination is not guaranteed using various known devices, as recently presented (Glenn Austin et al., "Cross-contamination Tests for Inoculation Jet Syringes - A Preliminary Report", in PATH, Seattle , WA, 98109). Other studies have shown an extremely dangerous situation. For example, studies in Russia and Brazil have shown that unlucky figures rise to 1.0% of the study subjects - exceeding the risk level so large that it cannot be ignored.

When the various jet injectors were introduced in the 1940s, they were popular with needle-phobic patients and patients with small veins. Advances have allowed jet syringes to deliver billions of prophylaxis that have saved countless lives. However, when pathogen transfer was found to occur, jet injectors fell out of favor to such an extent that the World Health Organization (WHO) and the US Department of Defense no longer recommended their use.

For example, an outbreak of hepatitis B in the mid-1980s was caused by the use of a high-duty syringe in a weight loss clinic. This is known from "Hepatitis B Outbreak and Jet Injectors in a Weight Loss Clinic" by Canter et al., 1990, Arch. Intern. Med. (Vol. 150, pp. 1923-1927).

The current parenteral injection technique has recently been considered by the World Health Organization (WHO) to be in conflict with the requirements of its planned Global Program on Vaccination and Immunization (GPV) initiative. It is estimated that by 2005, six additional parental vaccines will be recommended for childhood immunization, requiring a total of 3.6 billion immunization syringes per year. The total number of parental injections, including injected drugs and vaccines, will be approximately 10 times that number. This is in addition to the needs in the military recruiting centers, needs in the case of contagious diseases, worldwide immunization needs, and veterinary needs, etc. The billions of needs. Major healthcare providers such as UNICEF (UNICEF--United Nation International Children's Emergency Fund), World Health Organization (WHO) and Centers for Disease Control (CDC-Centerof Disease Control) have recently identified the need for a basic New technology that can be used by individuals with minimal training and that is safer, more convenient and more comfortable than syringes and needles. (See Jodar L., Aguado T., Lloyd J., and Lambert P-H, "Revolutionizing Immunization," Gen. Eng. News (1998) 18, p. 6.)

In other words, use as a terrestrial range life rescuer becomes a less than ideal product. The present invention addresses these issues associated with pathogen transfer, and addresses many of the issues associated with the high cost of disposable units.

Accordingly, in the technology of needle-free injection devices, the problem of cross-contamination in mass vaccination needs to be solved. More specifically, there is a need for a protective device for the nozzle tip of a needle-free injector that blocks "splashback" of contaminants and that is low enough cost to be used as a Disposable device application.

Invention Overview

The present invention solves the above-mentioned problems and achieves technical progress. Disclosed is an injection device in which a protective layer is used in combination with other components to minimize or eliminate backsplash.

                  Brief Introduction

Figure 1 shows an exploded view of a simple embodiment of the invention.

Figure 1A shows this simple embodiment in an assembled state.

Figure 2 shows an exploded view of another embodiment of the invention, in which another element is introduced.

Fig. 3 shows an exploded view of another embodiment of the invention in which some elements have been modified.

Fig. 4 and Fig. 4A show other embodiments of the present invention, in which the protective layer is arranged at different positions or has different structures.

Fig. 5 shows another embodiment of the present invention, wherein the provided middleware is shown.

Fig. 6 shows yet another embodiment of the present invention, wherein a protective layer is shown in different positions.

Detailed description

Figure 1 shows an exploded view of the invention. Syringe assembly 10 is shown. One function of the syringe assembly 10 is to enable needle-free injection of the drug into the skin 12 . As described herein, syringe assembly 10 is provided with a layer, such as protective layer 14 . The protective layer 14 generally comprises a material adapted to allow injection of the drug in one direction while minimizing or stagnating reverse flow of the drug. In this regard, protective layer 14 may function as a back splashguard. Specifically, for example, and not as a limitation of the embodiment, an optional baffle 16 may be provided to facilitate the reduction of reverse flow. The source of the drug jet is from the syringe 18 . Common syringes include Med-E-Jet(R), Ped-O-Jet(R), Ammo-Jet(R), and similar syringes. The barrier 16 also includes a barrier aperture 20 which can take any desired shape and size depending on the application. In this regard, the size of the baffle apertures 20 will affect how much reverse flow hits the protective layer 14 . It is contemplated that in all embodiments, the baffle apertures 20 may be sized to minimize disturbance to the drug jet while maximizing the protection provided by the protective layer 14 . If the baffle apertures 20 are too small, the baffle 16 may interfere with the drug jet, thus reducing the energy of the jet. If it happens that the jet energy is reduced too much, then the jet will not be able to penetrate the skin 12 in the desired manner to the desired depth.

The bulkhead 16 can be sized to accommodate the desired shape and can optionally include a bulkhead wing 15 . Naturally, the length and diameter may vary significantly, but in one example, the partition 16 may be approximately greater than 11 mm in diameter and greater than 5 mm in length. Typically, the diameter of the diaphragm aperture 20 should be slightly larger than the diameter of the drug jet. Therefore, it does not really matter how big the small hole of the dividing plate is, as long as the diameter of the small hole of the dividing plate is slightly larger than the diameter of the jet, no matter how big the injection small hole 22 of the syringe is.

The syringe 18 has a syringe aperture 22 disposed at the distal end of the syringe conduit 24 through which the drug to be injected exits the syringe aperture 22 and pierces the protective layer 14 . The drug jet then enters the diaphragm aperture 20 and hits the skin 12 . The energy of the drug jet is selected to ensure the desired depth and site of injection. For example, for deeper injections, greater energy will be required. The drug jet then enters the skin 12 and travels to the desired location. However, impacting the skin 12 is not without some accompanying effect. One effect is the dislodgement and detachment of surface tissues, fluids, cells and cellular contents from the surface of the skin 12 and fly around. Splashback of such debris may travel in the opposite direction of the jet and strike the baffle 16 and protective layer 14 . However, debris typically does not travel fast enough to penetrate the protective layer 14 again. In this regard, protective layer 14 stagnates or minimizes entry of debris into syringe aperture 22 and syringe 18 due to backsplash. One of the functions of the protective layer 14 is to avoid contamination of the syringe. In this regard, the simple concept of the present invention is to protect the syringe orifice 22 from contamination. In this way, it is possible for the syringe itself to bear the protective layer 14 without the use of the spacer 16 . Thus, a first element may comprise at least a syringe, a septum or a bushing.

Materials selected for the protective layer 14 include any material that facilitates penetration of the fluid jet in one direction, but stagnates fluid flow from penetrating in the opposite direction. For example, the protective layer may comprise a biochemically inert material approved for use in contact with the drug, such as, but not limited to, at least one of the following materials, including plastics, rubber, polymers , polyethylene, polytetrafluoroethylene, polyurethane (ethylene), polypropylene, polyolefin and polysulfone materials. In this regard, a material that allows penetration by the jet in one direction, but seals itself after the jet stops is more desirable. Desirably one or more protective layers are thin, for example greater than 0.001 mm. Preferably but not exclusively, the thickness may be in the range of about 0.004 to 0.08 mm, further about 0.2 to 0.5 mm. It should be noted that the selected thickness may vary. The protective layer 14 may also be textured, woven, woven, or if desired, made to ensure better bonding, or to ensure better set-up, or to prevent or minimize movement. For example, the protective layer may have various forms of grooves. As indicated, the diameter of the protective layer (in the case of a disk, or its width in the case of a strip) should be slightly larger than the diameter of the jet.

As shown in Figure 1, its various components are shown in an exploded view. In assembly, the septum 16 may be designed to fit within the syringe 18 and generally sandwich the protective layer 14 between the septum 16 and the syringe 18 . It is desirable to align the syringe aperture 22 with the bulkhead aperture 20 to minimize any attenuation of the energy of the jet. As with any connection and assembly herein, the bulkhead 16 may be suitably configured for a friction fit fit, a snap-in snap fit, a threaded fit, or a grooved reverse taper fit. Any of the components here may also be heat-sealed mounted. The protective layer 14 can also be glued or welded or otherwise disposed on the syringe 18, the septum 16 or any other parts as required.

Figure 1A shows a simple embodiment of the invention. As can be seen, the protective layer 14 may generally be sandwiched between the septum 16 and the syringe 18 . The protective layer 14 may be generally sandwiched or partially sandwiched between the elements described herein. When the drug is injected through the syringe channel 24 and the syringe aperture 22, it will penetrate the protective layer 14 and pass through the barrier aperture 20.

It should be noted that in any embodiment of the invention, the drug does not need to be liquid. In addition to aqueous solutions, the present invention may employ suspensions, aqueous colloids, emulsions or controlled release injectables. Other dosage forms include powders. For example, Powderject Pharmaceuticals of Oxford, England, and/or Powderject Vaccines of Madison, Wisc. have developed a syringe that advances a powdered drug in the same manner as a traditional needle-free injector. See, for example, US Patent Nos. 5,733,600, 6,053,889, and 5,899,880, the disclosures of which are expressly incorporated herein in their entirety. Since the drug in powder form accounts for less than 1% of the volume of the drug in liquid form, it is also desirable to adapt powder syringes for use in accordance with the present invention. Typically, but not exclusively, the possible range of particle sizes for a powder drug is typically no more than 50 microns compared to the 500 micron diameter size of a syringe needle. In other words, vaccines in powder form, such as recombinant DNA-based vaccines, including hepatitis B and HIV vaccines, and other powder form drugs used to treat influenza, tetanus, erectile dysfunction, allergies, pain, cancer, etc. being considered. These powdered substances may be mixed with a small amount (eg, about 1-10%) of sterile water or other physiologically acceptable diluents to form a paste or suspension. It is therefore within the purview of a person of ordinary skill in the art to modify a powder syringe with a protective cap and/or protective film in accordance with the present invention.

Figure 2 shows another embodiment of the invention. The syringe assembly 10 is shown having a bulkhead 16 and a bushing 26 . The liner 26 can suitably be manufactured with a liner reservoir 27 . The bushing 26 also has a bushing distal aperture 28 . The liner 26 may suitably be mounted with the bulkhead 16 so that it provides the added benefit of preventing backsplash during or after injection. The bushing 26 may be suitably mounted on the septum 16 such that the bushing 26 is used to help properly stretch the skin in the particular injection modality (intramuscular, subcutaneous or intradermal). As shown in the specific case by way of example and not limiting of the embodiment, the protective layer 14 is generally partially or fully disposed between the septum 16 and the syringe aperture 22 . In this arrangement, the jet exits syringe aperture 22 , penetrates protective layer 14 , exits through bulkhead aperture 20 and bushing distal aperture 28 to impinge skin 12 . Debris of the skin will splash back on the liner 26 , and any debris that flies into the distal aperture 28 of the liner will likely be blocked by the partition 16 . In the event that the trajectory of the debris allows the debris to pass through the bulkhead aperture 20 , the debris will strike the distal surface 29 of the protective layer 14 .

In this regard, the syringe orifice 22 is protected from contamination. Debris hitting the protective layer distal surface 29 will likely fall into the reservoir 27 and collect there. Bushings 26 may be suitably installed within bulkhead 16 when desired. One advantage of this way of arranging the bushing is the ease of handling of the device. As far as the arrangement is concerned, the syringe aperture 22 can be at a distance from the skin 12 . For example, it may be adjacent to the skin (in this case, no spacer or bushing is used and the protective layer 14 is placed directly on the syringe 18), or several millimeters away from the skin, for example 2-15mm away. Naturally, the chosen distance will affect the energy of the jet. Ideally, the distance of the syringe aperture 22 from the skin 12 is chosen to take this into account. In some arrangements, the skin-adjacent surface of the partition may be several millimeters away from the skin, for example 2-15mm, preferably 2-7mm. The diameter of the bushing aperture 28 can therefore also be set to 0.001 mm or larger. However, in one commercial embodiment, the liner 26, barrier 16 and protective layer 14 are discarded as an assembly once contaminated.

Figure 3 shows another embodiment of the invention. Shown are the septum 16 , bushing 26 , protective layer 14 and syringe 18 . In this arrangement, the baffle 16 suitably provides a larger surface area exposed to areas of potential backsplash. The liner 26 is also adapted to minimize backsplash contamination. For example, bushing 26 has an inner bushing surface 30 and an outer bushing surface 32 . As shown in dashed lines, the bushings 26 may be arranged to form "wings" in which the bushings 26 will cooperate with the diaphragm 16 . The diaphragm 16 has a diaphragm inner surface 34 that cooperates with the bushing 26 . As shown in this embodiment, the bushing outer surface 32 cooperates with the diaphragm inner surface 34 . The wings of the bushing 26 approach each other to form a bushing proximal aperture 36 . In this embodiment, any backsplash skin debris that enters the liner distal aperture 28 will likely hit the liner inner surface 30 or the bulkhead inner surface 34, or the distal surface 29 of the protective layer 14 . Where the liner 26 is provided without wings, any debris may still hit the liner inner surface 30 , the septum inner surface 34 or the distal inner surface 29 of the protective layer 14 .

Figure 4 shows yet another embodiment of the invention. Shown are several protective layers 14 indicated by dashed lines 38 . In this non-limiting example, the protective layer 14 is shown covering the diaphragm aperture 20 . The protective layer can be made integrally with the partition 16, or can be pasted on the partition 16 separately. In this embodiment, the separator 16 is removable to facilitate handling. It is also shown to have multiple protective layers. The protective layer can generally be found adjacent to the skin, aligned with the bushing distal aperture 28, adjacent to the bushing distal aperture 28, away from the septum 16, away from the septum aperture 20, aligned with the septum aperture 20, or Adjacent to the diaphragm aperture 20 . The number of protective layers can be chosen to maximize jet energy for penetration purposes, but minimize possible backsplash contamination. Also shown in FIG. 4 is an assembly wherein both the bushing 26 and the bulkhead 16 are disposed within the syringe assembly 18 . Multiple protective layers are used here, which may be adhesive, heat-sealed, or sandwiched protective layers.

As shown in Figure 4A, it should be noted that in any of the embodiments herein, the protective layer 14 or protective film need not be a separate piece. Instead, it can be integral with an element such as a diaphragm. For example, the protective layer may be part of the septum 16, wherein the area to be pierced by the jet is suitably exposed during injection. For example, if the partition is made of plastic, then the area for the protective layer could be made integral with the partition, but "dropped" slightly to make it thinner or more amenable to easy perforation. In yet another embodiment, the protective layer can be formed separately and then bonded in some way to an element, such as the spacer 16 . In another embodiment, the lowest of the embodiments shown in Figure 4A, several layers of films (shown in dashed lines) may also be used.

Figure 5 shows yet another embodiment of the present invention. The bulkhead 16 is provided with a number of bulkhead legs 40 . The bulkhead legs 40 may suitably cooperate with the middle piece 42 . Intermediate member 42 has a proximal end and a distal end such that various components may be located at either or both ends. In this specific example, which does not limit the embodiment, the middle piece 42 has a middle piece small hole 44 therethrough. The middle piece aperture 44 may be formed by one or more middle piece extensions 46 . As with any orifice described herein, the size and shape of the orifice may determine potential backsplash contamination and interference with jet energy. Intermediate piece 42 may be connected to syringe 18 and/or septum 16 and/or bushing 26 via intermediate piece connector 48 . The intermediate piece connector 48 may comprise any means to place one piece on another, and may further include a friction fit, a grooved counter-cone fit, or a threaded fit.

Thus, when medication is withdrawn from the medication vial 50, the medication is drawn into the syringe chamber 52, wherein the injection system then passes the medication through the syringe channel 24, through the syringe aperture 22 into the middle piece 42, through the middle piece aperture 44 and then through various remote components. As shown in Figure 5, after the drug exits the middle piece aperture 44, it will penetrate the protective layer 14, and then enter the partition 16 through the partition aperture 20, then pass through the bushing reservoir 27, and pass through the bushing distal aperture. 28, followed by impingement on the skin. Skin debris may enter the liner 26-baffle 16 assembly if tracked correctly. Debris may either strike the bulkhead 16 , such as the bulkhead splash guard 54 or the liner 26 itself, or possibly the protective layer distal surface 29 . In the event that the debris has sufficient energy to puncture the protective layer 14 again, the debris will then strike the intermediate piece 42 , for example the intermediate piece extension 46 . Thus, the only way the syringe tip can become contaminated is if the debris enters the intermediate piece 42 with such a precise trajectory that it passes through the aperture 44 and hits the syringe aperture 22 directly. However, although not shown in FIG. 5 , several protective layers 14 may be provided along different stages of the liner 26 , bulkhead 16 or intermediate piece 42 . The intermediate piece may also include an optional intermediate piece channel 56 in fluid communication with the atmosphere and intermediate piece cavity 57 . This allows the pressure in the middleware chamber 57 to equalize and allows any debris in the middleware chamber 57 to be expelled. As for size, the middle piece channel can be close to any size, but about 1mm.

Accordingly, syringe assembly 10 employs various components to improve protection against contamination. It should be noted that in any and all embodiments described herein, no one element is critical or essential to practicing the invention. For example, the embodiment shown in FIG. 5 may be configured so that it does not have a liner 26 , a spacer 16 , a protective layer 14 or intermediate piece 46 . In Figure 5, the addition of bushing 26 and bulkhead 16 provides additional benefits.

Figure 6 shows yet another embodiment of the present invention. In this embodiment, bushing 26 serves multiple roles. First, the bushing 26 is provided with a bushing connector 60, shown here as a threaded mount by way of example only. The middle piece 42 is provided with a middle piece distal connector 62, shown here as a threaded connector by way of example only. Thus, the intermediate piece distal connector 62 cooperates with the hub connector 60 to provide a detachable arrangement. The liner 26 suitably provides the same features as the bulkhead 16 (not shown), wherein it may also suitably have a liner splashback 64 . While protective layer 14 is shown adjacent to liner 26 , intermediate member 42 may also include an intermediate member protective layer 66 disposed anywhere along intermediate member 42 . This middle piece protective layer 66 is indicated by dashed lines, either away from the middle piece aperture 44 and aligned with the small hole 44 or close to the small hole 44 . In this regard, the middle piece protective layer 66 is remote from the syringe aperture 22 . During injection operations, debris entering the liner 26 will likely strike the liner splashback guard 64 , the protective layer 14 , the midpiece extension 46 or the midpiece protective layer 66 . In this respect, the detachability of the individual components is improved, wherein the inner surface 68 of the intermediate piece is generally kept clean, wherein most of the debris stays in the bushing 26 or hits the protective layer 14 , 66 .

It should be understood that the invention described herein is illustrated in sketches only. None of the embodiments shown here are intended to limit the invention. It will be apparent to those skilled in the art that changes and modifications may be made without departing from the scope of the invention as defined in the appended claims.

Claims (43)

1. injector assembly, this injector assembly comprises:

A) syringe, it has a near-end and a far-end, and this syringe comprises a syringe bore at far-end;

B) first element, this first element have the first element aperture of perforation, and first element is arranged on the far-end of syringe;

C) second element, this second element have the second element aperture of perforation, and second element is arranged on the far-end of syringe;

D) protective layer, it covers in the first and second element apertures at least one;

Wherein, first element, second element and protective layer have such structure at the far-end of injector assembly, in injection process and/or afterwards, can prevent that the chip splash from entering syringe bore.

2. injector assembly as claimed in claim 1, wherein, first element is a dividing plate.

3. injector assembly as claimed in claim 1, wherein, contiguous first element of protective layer.

4. injector assembly as claimed in claim 1, wherein, protective layer is the material that a kind of jet that allows medicine penetrates this protective layer.

5. injector assembly as claimed in claim 4, wherein, protective layer be following material one of them, these materials are plastics, rubber, polymer, polyethylene, politef, polyurethane, polypropylene, polyolefin and polysulfone material.

6. injector assembly as claimed in claim 4, wherein, contiguous first element of protective layer.

7. injector assembly as claimed in claim 1, wherein, second element is a lining.

8. injector assembly as claimed in claim 7, wherein, the contiguous lining of protective layer.

9. injector assembly as claimed in claim 7, wherein, protective layer is a polymeric material.

10. injector assembly as claimed in claim 9, wherein, protective layer be following material one of them, these materials are plastics, rubber, polymer, polyethylene, politef, polyurethane, polypropylene, polyolefin and polysulfone material.

11. injector assembly as claimed in claim 7, wherein, first element is a dividing plate, and protective layer is arranged between dividing plate and the lining.

12. injector assembly as claimed in claim 1, wherein, protective layer allows the powder jet of medicine to pass.

13. injector assembly as claimed in claim 12, wherein, contiguous first element of protective layer.

14. an injector assembly, this injector assembly comprises:

A) syringe, it has a near-end and a far-end, and this syringe comprises a syringe bore at far-end;

B) first element, this first element has an aperture that runs through, and first element is arranged on the far-end of syringe;

C) second element, this second element has an aperture that runs through, and second element is arranged on the far-end of syringe;

D) protective layer, it is arranged on the far-end of syringe, cover syringe bore, the first element aperture and the second element aperture at least one of them;

Wherein, first element, second element and protective layer have such structure in injector tip, in injection process and/or afterwards, can prevent that the chip splash from entering syringe.

15. injector assembly as claimed in claim 14, wherein, first element is a dividing plate.

16. injector assembly as claimed in claim 14, wherein, first element is a lining.

17. injector assembly as claimed in claim 14, wherein, second element is a dividing plate.

18. injector assembly as claimed in claim 14, wherein, second element is a lining.

19. injector assembly as claimed in claim 14, wherein, contiguous second element of first element.

20. injector assembly as claimed in claim 14, wherein, protective layer or contiguous first element, perhaps contiguous second element.

21. injector assembly as claimed in claim 14, wherein, contiguous first element of protective layer and second element.

22. injector assembly as claimed in claim 14, wherein, contiguous second element of protective layer and away from first element.

23. injector assembly as claimed in claim 14, wherein, protective layer cover at least the first element aperture and the second element aperture one of them.

24. injector assembly as claimed in claim 14, wherein, injector assembly comprises several protective layers.

25. injector assembly as claimed in claim 14, wherein, at least several protective layers one of them away from first element or second element.

26. injector assembly as claimed in claim 14, wherein, first element is a dividing plate, and second element is a lining, and protective layer is away from first element.

27. an injector assembly, this injector assembly comprises:

A) syringe, it has a near-end and a far-end, and this syringe comprises a syringe bore at far-end;

B) first element, this first element have the first element aperture of perforation, and first element is arranged on the far-end of syringe;

C) second element, this second element have the second element aperture of perforation, and the second componentry ground is away from first element and be arranged on the far-end of syringe;

D) middleware;

E) protective layer, this protective layer are arranged between the middleware and the second element aperture;

Wherein, first element, second element and protective layer have such structure at the far-end of injector assembly, in injection process and/or afterwards, can prevent that the chip splash from entering syringe bore.

28. injector assembly as claimed in claim 27, wherein, middleware also comprises a connecting element.

29. injector assembly as claimed in claim 28, wherein, connecting element at least also comprise friction adapter, trough of belt counter bore adapter and screw connected adapter one of them.

30. injector assembly as claimed in claim 28, wherein, middleware also comprises a kind of connecting element that is arranged on each end of middleware.

31. injector assembly as claimed in claim 29, wherein, middleware also comprises a kind of connecting element that is arranged on each end of middleware.

32. injector assembly as claimed in claim 27, wherein, this syringe also comprises a kind of connecting element.

33. injector assembly as claimed in claim 32, wherein, the syringe connecting element is used for engaging with middleware.

34. injector assembly as claimed in claim 32, wherein, protective layer is away from syringe.

35. injector assembly as claimed in claim 34, wherein, middleware comprises that also connects an aperture that extends.

36. injector assembly as claimed in claim 35, wherein, the middleware aperture is aimed at the first and second element apertures.

37. injector assembly as claimed in claim 36, wherein, protective layer away from syringe contiguous first or second element one of them.

38. a method for preparing the syringe that is used to carry out Needleless injection, this syringe have near-end, far-end and in the syringe bore of far-end, comprise the following steps:

A) protective layer is applied on the syringe, so that the pollution minimum of syringe; With

B) location first element, second element and at the protective layer of the far-end of syringe with in injection process and/or afterwards, prevents that the chip splash from entering syringe bore.

39. an injector assembly, this injector assembly comprises:

A) syringe, it has a near-end and a far-end, and this syringe comprises a syringe bore at far-end;

B) first element, this first element have the first element aperture of perforation, and first element is arranged on the far-end of syringe;

C) second element, this second element have the second element aperture of perforation, and second element is arranged on the far-end of syringe;

D) a plurality of protective layers, it covers in the first element aperture and the second element aperture at least one;

Wherein, first element, second element and a plurality of protective layer have such structure at the far-end of injector assembly, in injection process and/or afterwards, can prevent that the chip splash from entering syringe bore.

40. injector assembly as claimed in claim 39, wherein, a plurality of protective layers at least one of them away from first element or second element.

41. injector assembly as claimed in claim 39, wherein, a plurality of protective layers at least one of them near first element or second element.

42. injector assembly as claimed in claim 40, wherein, a plurality of protective layers are polymeric material.

43. injector assembly as claimed in claim 42, wherein, a plurality of protective layers be following material one of them, these materials are plastics, rubber, polymer, polyethylene, politef, polyurethane, polypropylene, polyolefin and polysulfone material.

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