JP2003528699A - Needleless syringe with prefilled cartridge - Google Patents

Abstract

SUMMARY OF THE INVENTION The present invention provides a cartridge and nozzle assembly (10) having a nozzle (14) having a valve receiving portion that includes a plurality of channels to facilitate the flow of an injectate through a nozzle orifice. I do. Specifically, the assembly comprises a cartridge (12) having a plunger (24) disposed at a rear end thereof and having an inner portion having a throat (21) at a front portion thereof, wherein the cartridge has a substantially side surface. And an interface surface extending inward.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD OF THE INVENTION

This application is a partial continuation application of 09 / 207,398 filed on Dec. 8, 1998. The present invention relates to a needleless injection system having a prefilled cartridge.

[0002]

[Prior Art and Problems to be Solved by the Invention]

One of the problems inherent in the packaging of liquid parenteral drugs is the lack of sufficient biocompatibility data on the interaction between those drugs and the thermoplastic container. . While plastics are commonly used in many infusion devices, most parenteral drugs can be barely exposed to plastic except for the short period immediately prior to injection. This is because the drug or injectate may chemically react with the plastic, and the substance in the plastic may leach into the injectate, which may introduce impurities into the drug. In the case of long storage times, such contact with plastic containers can cause drug decomposition reactions. For these reasons, the pharmaceutical industry generally avoids storing injectables in some thermoplastic materials, such as polypropylene, which is commonly used in syringes and related sets of injection devices. Similarly, biocompatibility data for engineered or high strength thermoplastics such as polycarbonate, the most commonly used plastic in needleless injection systems, has long been absent.

For this reason, injectables are typically stored in glass vials. Immediately prior to injection, the injectate chamber of the needleless injection system is filled from a glass vial with the drug contained therein. This usually involves the use of a vial adapter, also called a blunt fill device, or access needle, which penetrates the protective membrane at the top of the vial, thereby guiding the injectate into the chamber or cartridge of the needleless injection system. I need.

There are many drawbacks to this conventional approach. For example, the extra step of having to transfer the drug from a glass vial to a needleless infusion system is time consuming and also for patients who are trying to administer at home and who may be physically frail. It can be complicated. Even for people who are not frail, the adapter must be picked up and sterilized to prevent contamination of the infused material. Adapters typically include a transfer needle with a sharp tip at one end for penetrating the vial membrane. It can also lead to injuries, unintended introduction of the injectate into the handling personnel or medication and / or contamination of the injectate. The extra step of filling the needleless injection system immediately prior to this injection also introduces the possibility of leakage and waste of the injected material, which can introduce air into the injection system if improperly performed. Unlike conventional needle-syringe systems, introducing air is an obstacle to needle-free infusion systems because it is not easy to force air out of the chamber of a needle-free device. Thus, the release of an infusion system with a portion of its chamber filled with air causes a lower dosage to be infused into the patient. It can also cause infusion at inadequate pressure. Bi, the assignee of this patent
One advantage of oject's needleless injection systems is that they allow for the injection of a precise, predetermined volume of injectable material at a precise location in the tissue of a patient.
The introduction of air can make it difficult to achieve such accuracy.

The present invention has been made in view of such circumstances, and an object thereof is to provide a prefilled cartridge used in a needleless injection system.

[0006]

[Means for Solving the Problems]

The present invention provides a cartridge and nozzle assembly having a nozzle having a valve receiving portion that includes a plurality of channels to facilitate the flow of injectate through the nozzle orifice. Specifically, the assembly comprises a cartridge having a plunger disposed at a rear end thereof and having an inner portion having a throat at a front portion thereof, the cartridge further comprising a generally laterally extending interface surface. . Also,
Included within the throat is a moveable outlet valve that is initially located, the outlet valve having a channelless valve body. The nozzle receives a cartridge with a rearwardly directed cartridge receiving portion and includes a front portion defining a valve receiving portion having a plurality of channels and an injection orifice. Thus, the inner portion of the cartridge advances liquid through the channel to the orifice. The nozzle also includes a generally extended interface surface that abuts the interface surface of the cartridge. Finally, a seal is located behind the interface surface between the cartridge and the nozzle to prevent, or at least reduce, the leakage of injected material from between the cartridge and the nozzle.

Another aspect of the invention provides a method of making a needleless injection system. The method includes the following steps, but not necessarily in the order listed. (
1) A plunger that can be located at the rear end, an inner portion that has a throat at the front, and an outlet valve that can be located in the throat, and further has an interface surface that extends substantially laterally. Selecting a glass cartridge having, (2) positioning a seal behind the laterally extending interface surface of the cartridge, (3) positioning one of the plunger and the outlet valve in the cartridge, (4) filling the cartridge with injectable material before positioning the other of the plunger and the outlet valve in the cartridge, and (5) positioning the other of the plunger and the outlet valve in the cartridge, (6) Rear cartridge receiving portion with multiple channels and one therein A front portion defining a valve receiving portion having an injection orifice, the front portion being configured to receive the valve when the valve is moved to a forward position, the front portion being generally lateral. To select a nozzle that further has an interface surface extending to (7) to form a cartridge / seal assembly,
Mounting the cartridge in the nozzle such that the interface surfaces are adjacent and the seal is located behind such adjacency, (8) storing the cartridge / seal assembly in a sterile environment prior to use To do.

An additional aspect of the method is to apply a rearward pressure on the assembly such that an injector ram exerts a forward pressure on the plunger, such that the cartridge / Mounting a nozzle assembly and moving the outlet valve from the throat to the valve receiving portion, resulting in the injectate moving air in the front of the nozzle.

[0009] In this last-mentioned embodiment, actuation of the injector exerts the effect of injection, causing the ram of the injector to push the plunger forward, resulting in ejection of the injectate from the nozzle orifice. .

[0010]

DETAILED DESCRIPTION OF THE INVENTION

(Embodiment of FIGS. 1 to 10) The objects of the present invention are optimally achieved when the present invention has the form of the embodiment shown in FIGS. The present description first refers to these figures. Depicted generally as 10 is a cartridge / nozzle assembly in which the cartridge may be pre-filled with a liquid injectate. This assembly
The preferred embodiment includes a cartridge 12 formed of tempered glass and, in a preferred embodiment, a nozzle 14 formed of a high strength thermoplastic such as polycarbonate. The nozzle 14 has a conventional design except that it includes a plurality of protrusions at regular intervals in the rear (or left in FIG. 1) portion. In the depicted embodiment, four such protrusions are included, which are arranged 90 degrees apart around the nozzle, two of which are
One is indicated by a broken line in FIG. Alternatively, 3 or even more 2
Two such protrusions may be used.

While the cartridge 12 remains in the partially inserted position shown in dashed lines in FIG. 1, the projections 16 are radially disposed on the outer surface and are retained there by the cartridge wall 18. It It is easy to insert the cartridge 12 in this partially inserted position. This is because the wall 18 of the cartridge is tapered at 20 at its front end. The tapered wall 20 thus defines an internal throat 21 arranged at the front end of the cartridge 12. An O-ring 22 is disposed generally between the cartridge and nozzle 14 and adjacent this front tapered end of the cartridge 12. A step 28 is provided on the inner surface of the side wall 30 of the nozzle 14 to provide a stop and seal for the O-ring 22 disposed between the tapered portion 20 of the cartridge wall 18 and the inner surface of the nozzle side wall 30. Therefore, the O-ring prevents the flow of the injected material between the outer surface of the cartridge wall 18 and the inner surface of the nozzle side wall 30. A plunger 24 is arranged in the wall 18 of the cartridge 12,
Controls the injection of injectable material outside the cartridge as desired by the operator.
At the factory or at the user's point of use, the cartridge 12 is inserted into the nozzle 14 as shown in FIG. And then the cartridge 12 is shown in FIG.
As shown by the solid line in FIG.
4 is pushed forward until it abuts the cartridge abutment surface 26 at the front end of No. 4, and is completely pushed into the nozzle.

One of the advantages of the present invention is that the cartridge 12 is pre-filled with infusate and then either in factories, hospitals or other medical facilities, in pharmacies, ambulances or in the housing of patients in need of medical care. It can be stored in a suitable place. Alternatively, the cartridge 12 may be pre-filled and stored in position within the nozzle 14 ready for insertion into a needleless injector, such as generally indicated at 32 in FIG. .

A needleless injection system 32 in which the cartridge / nozzle assembly 10 is typically used is shown in US Pat. No. 5,399,163 to Peterson et al. However, the assembly 10 may be used with a wide variety of other needleless injection systems. The Peterson 163 patent is incorporated herein by reference. As shown in FIG. 3, the cartridge / nozzle assembly 10 includes a series of evenly spaced protrusions 3.
Attached to the front end 34 of the injector 32 by 6. Nozzle 1 with three protrusions 36
4 are arranged at intervals of approximately 120 degrees. The protrusion 36 in the nozzle 14 is positioned to pass through a corresponding space 38 located in the front end 34 of the injector 32. Thereafter, the cartridge / nozzle assembly 10 is rotated to lock it in such a position that the projection 36 is located between the inner surface 40 of the front end 34 of the injector 32 and the abutment surface 42 of the injector 32. When the cartridge and nozzle assembly is inserted into the injector 32, the front end of the ram 44 abuts a somewhat elastic Teflon pad 45 attached to the rear end of the plunger 24. Ram 44, pad 4
The contact between 5 and the plunger 24 is made before the projection 36 reaches the projection abutment surface 42 in the injector 32. The protrusion 36 is positioned opposite the protrusion abutment surface 42 so that the cartridge 12 continues to be pushed into the injector 32 while the stationary ram 44 slides the plunger 24 forward, resulting in The outlet valve 46 is advanced to the liquid injecting substance of FIG. 2 to allow the liquid to flow into the inner part 50 and toward the jet orifice 52 (see FIG. 1). The amount of liquid flowing through the outlet valve 46 during insertion of the cartridge 12 into the injector 32 is
It is controlled by the length of the ram 44 relative to the projection abutment surface 42.

As best shown in FIG. 4, the outlet valve 46 is disposed in contact with the inner surface of the tapered wall 21 at the front end of the cartridge 12. The valve 46 is typically formed of butyl rubber or other resilient material that can be sterilized prior to insertion into the cartridge 12. As shown in FIG. 4, the valve 46 is designed to fit snugly on the front end of the cartridge 12. As best shown in FIGS. 6-10, the middle portion or body 58 of the outlet valve 46 is typically circular in cross section so that it fits snugly within the tapered wall 20 of the cartridge 12. It is said to be the size. At the rear of the outlet valve 46 are four circular slots 5 arranged in the body portion 58 of the outlet valve 46 and extending rearward from the center.
6 is provided. A forwardly extending member 62 is provided at the front end 51 of the outlet valve 46 and extends axially from a body 58 of the outlet valve 46, defining two vertical valve channels 64.

In a preferred embodiment, the outer diameter of the outlet valve is tapered, such that the outer diameter of the outlet valve is approximately 0.105 inch and the inner diameter of the tapered wall is 0.098 inch. It is slightly smaller than the inner diameter of the wall 21. This dimensional difference allows for a friction fit on the front end of the cartridge 12 with some elastic properties of PTFE (polytetrafluoroethylene) or other material from which the outlet valve 46 is formed. However, once hydraulic pressure is exerted on the outlet valve 46, such as when the cartridge / nozzle assembly 10 is pushed into the needleless injector 32 while the ram 44 is stationary in the injector. , The outlet valve 46 is pushed forward to the initial pressurization position shown in FIG. 5, and the front end of the outlet valve 46 is located at the back portion 50 at the front end of the nozzle 14.
The valve abutting surface 48 is disposed so as to face the front end of the valve. The abutment surface 51 has a surface or a shoulder portion that extends in a direction substantially perpendicular to the longitudinal direction of the nozzle 14 and the moving direction of the outlet valve 46. The front end 51 of the outlet valve 46 has a surface that generally complements the shoulder of its abutment surface, which also extends perpendicular to the longitudinal direction of the valve and the direction of valve travel. The front end of the back 50 terminates in a jet orifice 52 having an orifice channel 54 that is generally conical in shape. The respective dimensional relationships of the outlet valve 46, the inner surface of the tapered wall 20, and the interior 50 allow liquid to flow from the cartridge into the interior surrounding the outlet valve and possibly out the injection openings 52. It is said that even things are possible. Operation of the Embodiments of Figures 1-10 In operation, at the factory or user location, the cartridge 12 is inserted into the nozzle 14 as shown by the dashed line in Figure 1, and then shown in solid line in Figure 1. As shown, the cartridge 12 is pushed completely into the nozzle until the tapered portion 20 of the wall 18 of the cartridge 12 abuts the cartridge abutment surface 26 at the front end of the nozzle 14. Before the cartridge / nozzle assembly 10 is installed in the injector 32, the outlet valve 46 remains in its pre-initial pressure position within the throat 21 of the cartridge 12, as shown in FIGS. With the valve in this position, the liquid contained in the cartridge will flow into the body portion 58 of the valve 46.
This prevents the throat 21 from flowing out.

The ram 44 within the injector 32 is held stationary so that the plunger against liquid placed in the cartridge 12 when the cartridge / nozzle assembly 10 is inserted into the injector 32. The pressure of 24 causes the outlet valve 46 to move to the forward initial pressure position shown in FIG. The outlet valve 46 having the slot 56 allows liquid in the cartridge to flow through the cartridge throat 21 and into the cartridge interior 50. The front valve channel 64 of the outlet valve 46 allows liquid to rapidly flow into the interior 50 and replace any air in the interior 50, expelling that air from the orifice channel 54 and the orifice 52. The interior, the orifice channel, and the opening are completely filled with injectate. This can also cause some injected material to drip from the jet orifice, but it is of little importance since it is a negligible amount. The important point is that all air is expelled from the front of the nozzle 14. This makes it possible to accurately measure the amount of infusate injected into the patient, which is not possible without knowing the amount of air entering the front of the nozzle. This also makes it possible to precisely schedule the pressure, which is not possible without the amount of air entering the front of the nozzle being able to be determined.

The step of inserting the cartridge / nozzle assembly 10 into the injector 32 is typically performed just prior to injection. Thus, with the assembly 10 installed, the needleless injector 32 is actuated, pushing the ram 44 and the plunger 24 forward, which causes the injectate to move through the slot 56 and into the outlet valve 46, where the depth 50. Flow around a body 58 disposed therein, through valve channel 64 into open channel 54 and open 52, and into the patient. The configuration of the outlet valve 46, the throat 21, and the inner wall of the inner part 50 pushes the liquid out of the cartridge and the ejection opening, and also causes a slight pressure drop. Embodiment of FIGS. 11, 12A and 12B FIGS. 11, 12A and 12B illustrate one alternative embodiment of a prefilled cartridge / nozzle assembly, generally designated 110. Embodiment 11
0 has an elastomeric membrane at the position of the outlet valve, which is designed to rupture and open when a given pressure is applied, as shown in FIGS. 12A and 12B. There is. Membrane 166 typically has a fragile portion where rupture occurs. In the depicted embodiment, this frangible portion is configured as a notch 167 that extends into most, but not all, of the throat 121 around the throat 121 inside the cartridge 112. Membrane 166 is held in place by aluminum seal 168, which is often used to help seal the cartridge, which typically contains the drug.

The other parts of the embodiment 110 are substantially similar to the embodiment 10 in that they have an O-ring 122 and a nozzle 114 and are generally pre-filled with an injectate. The membrane 166 ruptures and opens when the plunger (not shown) is slightly pushed by the injector ram (not shown) and loaded into the needleless injection system, as described above. Is designed. With the membrane 166 ruptured, the injectate flows into the back 155 of the front end of the nozzle 114, displacing any air and preparing the assembly for injection. Embodiment of FIGS. 13A and 13B FIGS. 13A and 13B illustrate another alternative embodiment of the cartridge / nozzle assembly, generally designated 210. This embodiment uses an aluminum seal 268 like embodiment 110, but also has an outlet valve 246. The outlet valve 246 has a pair of radially extending vanes 270 that pinch the outlet valve 246 under the aluminum seal 268 to a pressure sufficient to push the outlet valve 246 out of the internal throat 221 of the cartridge 212. To be When this predetermined pressure is reached, the valve 270 is withdrawn from the seal 268 and the valve advances into the interior 250 of the nozzle 214 until it contacts the nozzle abutment surface 248.

1-10, except for the presence of vanes 270.
Outlet valve 4 in cartridge / nozzle assembly 10 of
It is similar to 6. Thus, when the outlet valve 246 is moved to its forward position shown in FIG.
50 and any air is displaced, thus assembly 210 as previously described.
Prepares for injection. 14A-C embodiment The cartridge / nozzle assembly 310 of FIGS. 14A-C includes the assembly 210 except that the vanes 370 of the outlet valve 346 have weakened portions.
Is equivalent to In the depicted embodiment, these frangible portions are provided with a pair of notches 37.
It takes the form of 2. Thus, when the cartridge / nozzle assembly 310 is installed in a needleless injection system (not shown), the vanes 370 seal the seal 36.
Instead of being pulled out of engagement with 8, the vanes split generally out of notch 372, allowing the outlet valve to move to the forward position shown in FIG. 14C.
Other aspects of the operation of cartridge / nozzle assembly 310 are similar to assemblies 10 and 210 described above. Embodiments of FIGS. 15, 16A and 16B The cartridge / nozzle assembly 410 of FIGS. 15, 16A and 16B except that the interior 450 of the nozzle 414 has a plurality of evenly spaced ribs 474. , Which is equivalent to the assembly 10 of FIGS. In the depicted embodiment, four such ribs 474 are provided. These are, as shown in FIG.
The outlet valve 446 is sized to fit snugly in the interior 450. A channel 476 defined between ribs 474 allows liquid to flow from around outlet valve 446 to orifice 52. In other respects, cartridge / nozzle assembly 410 is constructed and operates in the same manner as assembly 10 of FIGS. 1-10. 17A and B Embodiments FIGS. 17A and 17B show another alternative embodiment of a cartridge / nozzle assembly, generally designated 510. The assembly includes a cartridge 5
12 and a nozzle 514. The cartridge 512 is pre-filled with the injectable material as described above, and is sealed with the aluminum seal 568 and the elastomer thin film 566. Spokes 578 are provided that penetrate the membrane 566 as the cartridge continues to be inserted into position in the nozzle, as shown in FIG. 17B. This is usually done just prior to injection. A plastic spike seal 580 is provided adjacent to the spike to prevent leakage of the injectate. The assembly 510 is then attached to the needleless infusion system and air is displaced to prepare the unit for infusion, as previously described.

In other respects, the cartridge / nozzle assembly is configured and operates similar to the previously described embodiments. Embodiments of Figures 18-22 Figures 18-22 illustrate another alternative embodiment of a cartridge / nozzle assembly. The assembly, shown generally as 610, includes a cartridge 612.
And a nozzle 614. FIG. 18 shows the assembly 610 screwed onto the needleless injector 632. The injector 632 is similar to the injector 32 described above, except for this screw attachment. Also, an anti-contamination cap 633 is shown in FIG. The cap is mounted over the front end of the nozzle 614 prior to use to prevent contamination of the nozzle orifice 652 and injectate contained in the cartridge / nozzle assembly 610.

The depicted anti-contamination cap 633 is shown to be hermetic. However, the cap 633 should be understood as allowing air and / or injectate to escape from the nozzle orifice 652 when hydraulic pressure is applied. Therefore, as described below, when the cartridge / nozzle assembly is attached to the injector 632, air and some of the injectate material will not flow through the cap 63.
It will pass through 3 and leak. Alternatively, it allows the cap to be securely attached to the front end of the nozzle 614, although the anti-contamination cap may have ribs that facilitate leakage of air and injectate from the nozzle during the attachment process. Good.

The cartridge 612 is usually made of tempered glass and is pre-filled with a liquid injecting substance. The illustrated nozzle 614 is formed of high strength thermoplastic, which is typically polycarbonate. Cartridge 6
12 has an outer wall 618 that is slightly sloped at its front 620.
Tapered wall 620 converges to form internal throat 621 at the front end of cartridge 612. An O-ring seal 622 is located adjacent to the front of it, the tapered portion of the cartridge 612 between the cartridge and the nozzle sidewall 630. In other words, the positioning of the O-ring 622 is located between the outer surface (outer wall 618) of the cartridge and the inner surface of the nozzle, adjacent the rear end of the throat. In the illustrated embodiment, a step 628 is shown on the inner surface of the sidewall 630 to provide O-ring stop and seal. Thus, when the cartridge is in place within the nozzle, the O-ring 622 prevents or at least reduces the flow of injectate along the interface between the outer surface of the cartridge wall 618 and the inner surface of the nozzle side wall 630, and is also suitable. Maintain the high pressure required for needleless injection.

A plunger 624 is disposed in the wall 618 of the cartridge 612 and controls the flow of injectate from the cartridge as desired by the operator. In a factory where medicines are aseptically filled (in a sterile environment), a cartridge 612 is inserted into a nozzle 614 and pushed forward as shown in FIG. 19, and the front end of the cartridge 612 is located behind the nozzle 614. It is pushed all the way into the nozzle until it abuts the cartridge abutment surface 626 at the end. This cartridge abutment surface 626 is sometimes referred to herein as a laterally extending interface surface.

As best shown in FIG. 19, the outlet valve 646 has a throat 62.
1 is initially located adjacent to the front end of the cartridge 612. In the illustrated embodiment, the outlet valve 646 is constructed in a spherical shape and is made of PTFE (polytetrafluoroethylene) or other elastic material suitable for drug storage and prior to insertion into the cartridge 612. It is made of materials that can be sterilized. As shown in FIG. 19, the outlet valve 646 is designed to fit snugly within the front end of the cartridge 612. Valve 6
Since 46 is spherically configured and, in the preferred embodiment, does not have any slots or openings therein and is sized to fit snugly within the throat 621 of the cartridge 612. , Cartridge throat 62
It may be said that it has a body that fits against one wall, which prevents the injectate from escaping the cartridge until the valve 646 is pushed out of the cartridge throat.

In a preferred embodiment, the outlet valve 646 has an outer diameter of 0.110.
The inner diameter of the throat 621 is 0.098 inch. This dimensional difference allows a friction fit on the front end of the cartridge 612, with some elastic properties of the PTFE or other material from which the outlet valve 646 is formed. In fact, if the outlet valve 646 is more elliptical than that shown in FIGS. 18 and 19, the fact that the inner diameter of the throat 621 is smaller than the diameter of the outlet valve 646 is obtained. Once hydraulic pressure is exerted on the outlet valve 646, the outlet valve 646 is pushed out of the cartridge throat 621 into the valve receiving cup 647 and against the valve abutment surface 648 at the front end of the valve receiving cup at the front of the nozzle 614. It can be pushed forward. This typically occurs when the assembly 614 is screwed into the receiving screw of the injector 632. This screwing step will cause the plunger 624 to be pushed slightly outward or forward (to the right in FIG. 18) and thus the outlet valve 646 as well. The front end of the valve receiving cup 647 terminates in a jet orifice 652 having a generally conical nozzle orifice channel 654. The valve receiving cup 647 is sometimes referred to herein as the interior of the nozzle.

A plurality of bypass channels 649 a , b and c are formed in the valve receiving cup 647 and valve abutment surface 648 to facilitate the flow of injectate from the cartridge 612 through the jet orifice 652. These are the openings between the valve and the channel when the outlet valve 646 is in any position of the valve receiving cup 647, or in the position opposite the valve abutment surface 648, where the injectate is orificed through the channel. Sufficiently dimensioned to provide sufficient clearance to bypass the jet orifice 652 from within the channel 654. In a preferred embodiment, the outlet valve 646 has a diameter of 0.
． 110 inches and the valve receiving cup is approximately 0.115 in diameter with the valve channel being 0.150 inches when measuring the diameter, or from the center of the valve receiving cup to the end of this channel. It is said to be 075 inches. When using a configuration with three bypass channels 649 a , b , c , each channel is approximately 45 ° wide and the channels are equally spaced, where each centerline is 1
20 degrees apart. Of course, other channel configurations can be used, or other configurations that allow liquid to pass through the outlet valve and into the orifice channel.

When the plunger 624 is pushed slightly forward, the pressure of the liquid infusate in the cartridge 612 pushes the outlet valve 624 out of the throat 621 into the valve receiving cup 647 and onto the valve abutment surface 648. Press against.
Therefore, the liquid injectate will flow through the valve receiving cup 647 and the channels 649 a , 64.
9 b and 649 c , filling nozzle orifice channel 654 and dripping from nozzle orifice 652. With the anti-contamination cap 633 in place, when the assembly 610 is screwed into place in the injector 632, this causes leakage of injectate from the cap.

When the device is ready for operation, the anti-contamination cap 633 is removed and the injector 632 is opened. This drives the plunger 624 forward, driving the injectate out of the orifice 652 and into the patient (not shown).

In other respects, the cartridge / nozzle assembly 610 is similar to that of FIGS.
Similar to that of the ten embodiments. (Operation of the Embodiment of FIGS. 18 to 22) The cartridge 612 is inserted into the nozzle 614 at a factory location where sterility is ensured. In such an insertion process, the cartridge 612 is pushed forward, and the front end of the cartridge is the front end of the nozzle and the cartridge contact surface 626.
Is completely pushed into the nozzle until it touches. This position is shown in FIG. Since the injectate is stored in a glass cartridge, the assembly can be stored for an extended period of time before use. It is usually stored in a sterile bag or bag (not shown). Many such cartridge / nozzle assemblies 610 can be delivered to a patient. In this state, the outlet valve 646 disposed in the throat 621 tightly seals the cartridge, prevents the injected substance from leaking to the outside of the cartridge, and prevents the injected substance from being contaminated. Anti-contamination cap 633
(Shown only in FIG. 18 and attached to injector after assembly)
Helps prevent pollution.

When the user is ready for dosing, the assembly 610 is removed from its bag or sterile bag and screwed onto the front end of the injector, shown as 632 in FIG. When this screwing is complete, the injection ram 644 is stationary in the injector, thus pushing the plunger 624 forward. This pushes the outlet valve 646 out of the cartridge throat 621 and also into the valve receiving cup 647, against the valve abutment surface 648. Thus, the injectate fills the entire air space at the tip of the nozzle, allowing air and some injectant to escape from the cap 633.

Once the cartridge / nozzle assembly is in place, the device is ready for injection. Immediately prior to injection, the anti-contamination cap 633 is removed from the nozzle 614, the nozzle is positioned against the patient's skin and the injector is activated.

In other respects, the operation of the cartridge / nozzle assembly 610 is essentially similar to that of the assembly 10 shown in FIGS.

Changes and modifications may be made to the invention without departing from the spirit and scope of the invention. Such modifications and improvements are intended to cover the following claims.

[Brief description of drawings]

FIG. 1 is a side sectional view of a prefilled cartridge of the present invention, showing its initial position before the cartridge is inserted by a broken line, and the insertion position before the initial pressurization by a solid line.

FIG. 2 is an end cross-sectional view taken along line 2-2 of FIG. 1, showing the cartridge in its insertion position.

FIG. 3 is a side cross-sectional view showing the position of the cartridge and nozzle in the preferred embodiment of the needleless injection system.

4 is a partial enlarged side cross-sectional view of the outlet valve and adjacent portions of the cartridge / nozzle assembly of the embodiment of FIG. 1, showing the outlet valve in a non-pressurized position.

5 is a view corresponding to FIG. 4, except that the outlet valve is shown in section and has been moved to the forward position.

[Figure 6]   2 is an enlarged side view of the outlet valve of the embodiment of FIG. 1. FIG.

[Figure 7]   FIG. 7 is a side sectional view taken along line 7-7 of FIG. 6.

8 is a cross-sectional end view taken along line 8-8 of FIG. 6, showing the front portion of the outlet valve.

9 is a cross-sectional end view taken along line 9-9 of FIG. 4, showing the rear portion of the outlet valve.

[Figure 10]   FIG. 10 is an isometric view of the outlet valve of FIGS. 1-9.

FIG. 11 is a side cross-sectional view of an alternative embodiment showing a membrane as a substitute for an outlet valve.

FIG. 12A   FIG. 12 is a side sectional view when the thin film of the embodiment of FIG. 11 is broken.

FIG. 12B   FIG. 12B is an isometric view corresponding to FIG. 12A.

FIG. 13A is a side cross-sectional view of the second alternative embodiment outlet valve in its closed position.

FIG. 13B is the same as FIG. 13 except that the outlet valve is shown in its forward position.
It is a figure corresponding to A.

FIG. 14A is an outlet valve equivalent, such as the outlet valve shown in FIGS. 13A and B, except that the valve vanes are provided with cuts to facilitate separation when pressure is applied to the valve. FIG.

FIG. 14B is a view corresponding to FIG. 13A, except that the type of outlet valve shown in FIG. 14A with a cut in the vanes is shown.

14C is the same as FIG. 14B except that the outlet valve is shown in its open position.
It corresponds to.

FIG. 15 is a partial side cross-sectional view of yet another alternative embodiment of a nozzle with a cartridge or outlet valve removed, showing the ribs at the back of the nozzle.

16A is an enlarged side cross-sectional view of the embodiment of FIG. 15 showing the cartridge and outlet valve in its closed position.

16B is an illustration of FIG. 16A except that the outlet valve is shown in its front position.
It is a figure corresponding to.

FIG. 17A   FIG. 7 is a side view of an alternative embodiment of the present invention.

FIG. 17B   It is a figure corresponding to that of FIG. 17A.

FIG. 18 is a side cross-sectional view showing the cartridge and nozzle positions in the alternative embodiment shown in FIGS.

19 is a side cross-sectional view of the embodiment of FIG. 18 when the plunger is in its rear position prior to mounting the assembly on the injector.

FIG. 20   FIG. 20 is an end cross-sectional view taken along line 20-20 of FIG. 19.

21 is a side cross-sectional view of the embodiment of FIG. 18 except that the plunger is shown in its forward position after the injectate has been injected from the assembly.

FIG. 22   FIG. 22 is an end cross-sectional view taken along line 22-22 of FIG. 21.

[Explanation of symbols]

10 Cartridge / Nozzle Assembly 12 Cartridge 14 Nozzle 16 Projection 18 Cartridge Wall 20 Tapered Wall 21 Internal Throat 22 O-ring 24 Plunger 26 Cartridge Contact Surface 30 Side Wall 32 Needleless Injection System 38 Space 40 Inner Surface 42 Contact Surface 44 Ram 45 Teflon (Registered trademark) pad 46 outlet valve 48 valve contact surface 50 back 52 jet orifice 54 orifice channel 56 circular slot 58 body 64 valve channel 110 cartridge / nozzle assembly 112 cartridge 114 nozzle 121 throat 122 O-ring 166 thin film 167 notch 168 aluminum Seal 210 Cartridge / Nozzle Assembly 212 Cartridge 214 Nozzle 221 Internal Throat 24 Outlet valve 250 Back 248 Nozzle contact surface 268 Aluminum seal 270 Vane 310 Cartridge / nozzle assembly 346 Outlet valve 368 Seal 370 Vane 372 Notch 410 Cartridge / nozzle assembly 414 Nozzle 446 Outlet valve 450 Back 474 Rib 476 Channel 510 Cartridge / nozzle Assembly 512 Cartridge 514 Nozzle 566 Elastomer Thin Film 568 Aluminum Seal 578 Spoke 610 Cartridge / Nozzle Assembly 612 Cartridge 614 Nozzle 618 Outer Wall 620 Tapered Wall 621 Inner Throat 622 O-Ring 624 Plunger 626 Cartridge Abutment 630 Nozzle Sidewall 632 Needle Injector Pollution cap 44 injection ram 646 outlet valve 647 valve receiving cup 648 valve contact surface 652 jet orifice 654 nozzle orifice channel 649 a ~ c bypass channel

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), OA (BF , BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, G M, KE, LS, MW, MZ, SD, SL, SZ, TZ , UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, B Z, CA, CH, CN, CR, CU, CZ, DE, DK , DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, J P, KE, KG, KP, KR, KZ, LC, LK, LR , LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, R O, RU, SD, SE, SG, SI, SK, SL, TJ , TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW F term (reference) 4C066 AA09 BB01 CC01 DD02 EE02                       FF10

Claims (18)

[Claims] 1. A cartridge and nozzle assembly for use in a needleless injection system, comprising an inner portion having a plunger disposed at a rear end thereof and having a throat at a front portion thereof, the outer portion being substantially lateral. A cartridge including an interface surface extending in a direction, a movable outlet valve initially disposed in the throat and having a channelless valve body, a nozzle for receiving the cartridge, and the cartridge and the nozzle. A seal disposed behind an interface surface between the cartridge and the nozzle to at least reduce leakage of injected material from between the nozzle, the nozzle defining a rear cartridge receiving portion, And a valve receiver having a plurality of channels defined therein and an injection orifice A minute-defining front portion, the front portion when the valve is moved to a forward position, such as when the outlet valve is moved from the throat to a valve receiving portion of the nozzle. Is configured to receive the valve, the inner portion of the cartridge advancing liquid through the channel to the orifice to define a generally laterally extending interface surface that abuts the interface surface of the cartridge. An assembly further comprising. 2. The cartridge throat is tapered and the seal is mounted adjacent a throat of the cartridge in a gap defined between the cartridge and the nozzle. 1. The assembly according to 1. 3. The assembly of claim 1, wherein the valve receiving portion of the nozzle is in the form of a recess having a valve abutment surface having the channel defined therein. 4. The assembly of claim 3, wherein the channel has a generally axially extending portion within the interior of the nozzle. 5. The assembly of claim 1, wherein the outlet valve has a smooth and regular surface. 6. The assembly of claim 5, wherein the outlet valve is rounded. 7. The outlet valve has a substantially spherical shape.
Assembly as described in. 8. The assembly of claim 7, wherein the outlet valve is elastic. 9. The cartridge is formed of glass.
Assembly as described in. 10. A cartridge having an inner portion having a plunger disposed at its rear end and having a throat at its front, and a throat of said cartridge further comprising a generally outwardly facing surface. A movable outlet valve disposed therein, a system for selectively providing a driving force to drive the plunger forward, a nozzle for receiving the cartridge, and the outwardly facing surface of the cartridge. Between the outwardly facing surface of the cartridge and the inwardly facing surface of the nozzle to at least reduce leakage of injectate between the nozzle and the inwardly facing surface of the nozzle. And a plurality of channels defined within the cartridge receiving portion and a plurality of channels defined therein. A front end terminating in and defining a valve abutment surface having an inlet orifice, said inner portion of said cartridge for advancing liquid through said channel to said orifice; The front portion is configured to receive the valve when the valve is moved to a forward position so that the valve is disposed opposite the valve abutment surface, and the front surface is configured to receive the valve. A needleless injection device further having a substantially inwardly facing surface that abuts. 11. The valve contact surface has a cup shape.
Assembly as described in. 12. The assembly of claim 11, wherein the outlet valve is rounded at least at a front end. 13. The assembly of claim 12, wherein the outlet valve is generally spherical. 14. The assembly of claim 1, wherein the outlet valve is elastic. 15. A method of making a needleless injection system, comprising a plunger positionable at a rear end, an inner portion having a throat at the front, and an outlet positionable within the throat. Have a valve,
Select a glass cartridge that further has a substantially laterally extending interface surface, locate a seal behind the laterally extending interface surface of the cartridge, and insert one of the plunger and the outlet valve into the cartridge. Filling the cartridge with injectable material and positioning the other of the plunger and the outlet valve in the cartridge before positioning the other of the plunger and the outlet valve in the cartridge. A cartridge receiving portion and a front portion defining a valve receiving portion having a plurality of channels and one injection orifice therein, the front portion defining when the valve is moved to a forward deployed position. Is configured to receive the valve and extends generally laterally Choosing a nozzle that further has an interface surface and placing the cartridge into the nozzle such that the interface surfaces are adjacent and the seal is located behind such an adjacency to form a cartridge / seal assembly. How to install. 16. The method of claim 15, further comprising positioning an anti-contamination cap on the front side of the nozzle. 17. A cartridge / nozzle assembly is further attached to the front end of the injector by exerting a rearward pressure on the assembly such that an injector ram exerts a forward pressure on the plunger. 16. The method of claim 15, wherein an outlet valve is moved from the throat to the valve receiving portion, resulting in the injectate moving air in the front of the nozzle. 18. The method of claim 17, wherein injecting is accomplished by actuating the injector, causing the ram of the injector to push the plunger forward, thereby ejecting the injectate from the nozzle orifice.