JP4709461B2 - Needleless syringe with prefilled cartridge - Google Patents

Description

[0001]
BACKGROUND 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 problem inherent in the packaging of liquid parenteral drugs is the lack of sufficient biocompatibility data on the interaction between those drugs and thermoplastic containers. . While plastic is commonly used in many infusion devices, most parenteral drugs can hardly be exposed to plastic except for a short period of time just prior to injection. This is because the drug or injectable material may chemically react with the plastic, and the material in the plastic may leach into the injected material, which may introduce impurities into the drug. If the storage period is long, such contact with the plastic container can cause a degradation reaction of the drug. For these reasons, it is usually avoided in the pharmaceutical industry to store the infused material in some thermoplastic materials, such as polypropylene, commonly used in syringes and associated injection device sets. Similarly, biocompatibility data for engineering or high strength thermoplastics such as polycarbonate, the most commonly used plastic in needleless injection systems, has not existed for a long time.
[0003]
For this reason, the injected material is typically stored in glass vials. Immediately prior to injection, the injection substance chamber of the needleless injection system is filled with the drug contained therein from a glass vial. This typically involves the use of a vial adapter, or access needle, also called a blunt fill device, which penetrates the protective film at the top of the vial and thereby directs the infused material into the chamber or cartridge of the needleless infusion system. I need.
[0004]
There are many drawbacks to this conventional approach. For example, the extra step of having to transfer medication from a glass vial to a needle-free infusion system is time consuming and is going to be dispensed at home, for patients who may be physically weak It can be cumbersome. Even for non-weak people, the adapter must be picked up and sterilized to prevent contamination of the injected material. The adapter typically includes a transfer needle with a sharp tip at one end for penetrating the vial film. It can also lead to injuries, unintentional introduction of the injected substance into the handling personnel or medication and / or contamination of the injected substance. The extra step of filling the needleless injection system just prior to this injection also introduces the possibility of leakage and waste of the injected material and can introduce air to the injection system if performed improperly. Unlike conventional needle and syringe systems, the introduction of air represents a bottleneck in the needleless injection system because it is not easy to expel air from the chamber of the needleless device. Thus, the release of an infusion system with a portion of the chamber filled with air causes a lower dosage to be infused into the patient. It can also cause injection with inappropriate pressure. One advantage of this patent-assigned Bioject needle-free injection system allows them to inject a predetermined amount of injected material precisely at a predetermined precise location in the patient's tissue. That is. The introduction of air can make it difficult to achieve such accuracy.
[0005]
This invention is made | formed in view of such a situation, and it aims at providing the prefilled cartridge used for a needle-free 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 infusate through the nozzle orifice. Specifically, the assembly includes a cartridge having a plunger disposed at a rear end thereof and having an inner portion having a throat at a front portion thereof, and the cartridge further includes an interface surface extending substantially laterally. . A movable outlet valve disposed from the beginning is included in the throat, and the outlet valve has a non-channel valve body. The nozzle includes a front portion that receives the cartridge with a rearwardly directed cartridge receiving portion and defines 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 extending interface surface that abuts the interface surface of the cartridge. Finally, a seal is disposed behind the interface surface between the cartridge and the nozzle to prevent or at least reduce leakage of the injected material from between the cartridge and the nozzle.
[0007]
Another aspect of the present invention provides a method of making a needleless injection system. The method includes the following steps, not necessarily in the order listed. (1) A plunger that can be positioned at the rear end, an inner portion having a throat at the front, and an outlet valve that can be positioned in the throat, and an interface surface extending substantially laterally. Select a glass cartridge further comprising: (2) a seal is positioned behind the laterally extending interface surface of the cartridge; and (3) one of the plunger and the outlet valve is positioned within the cartridge. (4) before placing the other of the plunger and the outlet valve in the cartridge, filling the cartridge with an injecting substance; and (5) placing the other of the plunger and the outlet valve in the cartridge. , (6) a rear cartridge receiving portion and a plurality of channels and 1 therein And a front portion defining a valve receiving portion having an injection orifice, wherein the front portion is configured to receive the valve when the valve is moved to a forwardly disposed position, Selecting a nozzle further having an interface surface extending in the direction, and (7) the interface surface is adjacent to form a cartridge / seal assembly, and the seal is disposed behind such an adjacency. A cartridge is installed in the nozzle and (8) the cartridge / seal assembly is stored in a sterile environment prior to use.
[0008]
An additional aspect of the method is to apply a cartridge / nozzle assembly at the front end of the injector by applying a backward pressure on the assembly such that the injector ram exerts a forward pressure on the plunger. Mounting, moving the outlet valve from the throat to the valve receiving portion, and consequently moving the air in the front of the nozzle to the injection material.
[0009]
In this last mentioned embodiment, the injection effect is exerted by driving the injector, and the plunger is pushed forward by the ram of the injector, so that the injection substance is discharged from the nozzle orifice.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
(Embodiment of FIGS. 1-10)
The objects of the invention are optimally achieved when the invention is in the form of the embodiment shown in FIGS. The description first refers to these figures. Depicted generally as 10 is a cartridge / nozzle assembly in which the cartridge can be pre-filled with a liquid injecting material. The assembly includes a cartridge 12 made of tempered glass in a preferred embodiment and a nozzle 14 made of a high strength thermoplastic, typical of polycarbonate in a preferred embodiment. The nozzle 14 has a conventional design except that it includes a plurality of protrusions at equal intervals in the rear (or left side in FIG. 1) portion. In the depicted embodiment, four such protrusions are included, which are arranged around the nozzle at 90 degree intervals, two of which are indicated by broken lines in FIG. Yes. Alternatively, three or even more so two such protrusions may be used.
[0011]
The protrusions 16 are radially disposed on the outer surface and held there by the cartridge wall 18 while the cartridge 12 is disposed in the partially inserted position shown in broken lines in FIG. It is easy to insert the cartridge 12 into this partially inserted position. This is because the cartridge wall 18 is tapered 20 at its front end. The tapered wall 20 thus defines an internal throat 21 that is disposed at the front end of the cartridge 12. An O-ring 22 is generally disposed between the cartridge and the nozzle 14 adjacent to the 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 stopping and sealing of an O-ring 22 disposed between the tapered portion 20 of the cartridge wall 18 and the inner surface of the nozzle side wall 30. This O-ring thus 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 disposed in the wall 18 of the cartridge 12 and controls the injection of the injected material out of the cartridge as desired by the operator. At the factory or at the user's location, the cartridge 12 is inserted into the nozzle 14 as shown in FIG. The cartridge 12 is then pushed forward 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 as shown by the solid line in FIG. Is pushed into.
[0012]
One of the advantages of the present invention is that the cartridge 12 is pre-filled with infusion material, and then any suitable location in the factory, hospital or other medical facility, pharmacy, ambulance, or the patient's home in need of medical care. It is possible to be stored in Alternatively, the cartridge 12 may be prefilled and stored in a position within the nozzle 14 and ready for insertion into a needleless injector as generally indicated at 32 in FIG. .
[0013]
A needleless injection system 32 in which the cartridge / nozzle assembly 10 is typically used is shown in US Pat. No. 5,399,163 by Peterson et al. However, the assembly 10 can 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 is attached to the front end 34 of the injector 32 by a series of equally spaced projections 36. Three projections 36 are arranged around the nozzle 14 at intervals of approximately 120 degrees. The protrusion 36 in the nozzle 14 is positioned to pass through a corresponding space 38 disposed at the front end 34 of the injector 32. Thereafter, the cartridge / nozzle assembly 10 is rotated to lock it in a position such that the protrusion 36 is disposed 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-nozzle assembly is inserted into the injector 32, the front end of the ram 44 abuts a somewhat resilient Teflon pad 45 attached to the rear end of the plunger 24. The contact between the ram 44, the pad 45 and the plunger 24 is made before the protrusion 36 reaches the protrusion contact surface 42 in the injector 32. The protrusion 36 is disposed opposite the protrusion abutting surface 42 so that the cartridge 12 continues to be pushed into the injector 32 and the stationary ram 44 slides the plunger 24 forward, resulting in the inside of the cartridge 12. The outlet valve 46 is advanced to the liquid injection material, and the liquid can flow into the inner portion 50 and toward the jet orifice 52 (see FIG. 1). The amount of liquid flowing through the outlet valve 46 while the cartridge 12 is inserted into the injector 32 is controlled by the length of the ram 44 relative to the protrusion abutment surface 42.
[0014]
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. Valve 46 is typically formed of butyl rubber or other resilient material that can be sterilized prior to insertion into cartridge 12. As shown in FIG. 4, the valve 46 is designed to fit securely to the front end of the cartridge 12. As best shown in FIGS. 6-10, the intermediate portion or body 58 of the outlet valve 46 is typically circular in cross-section so that it fits securely into the tapered wall 20 of the cartridge 12. It is said to be size. At the rear of the outlet valve 46, four circular slots 56 are provided, which are arranged in the body portion 58 of the outlet valve 46 and extend rearward from the center. A forwardly extending member 62 is provided at the front end 51 of the outlet valve 46 extending axially from the body 58 of the outlet valve 46 and defines two vertical valve channels 64.
[0015]
In the preferred embodiment, the outer diameter of the outlet valve is approximately 0.105 inches, and the outer diameter of the outlet valve is that of the tapered wall 21 such that the inner diameter of the tapered wall is 0.098 inches. It is slightly smaller than the inner diameter. This dimensional difference allows for a friction fit to the front end of the cartridge 12 by accompanying some elastic properties of the PTFE (polytetrafluoroethylene) or other material from which the outlet valve 46 is formed. However, once hydraulic pressure is applied to 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 to the initial pressurization position shown in FIG. 5 in the front, and the front end of the outlet valve 46 is disposed opposite to the valve contact surface 48 at the front end of the inner portion 50 at the front end of the nozzle 14. The The abutment surface 51 has a surface or shoulder that extends in a direction substantially perpendicular to the longitudinal direction of the nozzle 14 and the movement 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, and this surface also extends perpendicular to the longitudinal direction of the valve and the direction of movement of the valve. The front end of the back 50 ends with a jet orifice 52 having an orifice channel 54 that is generally conical. The dimensional relationship between the outlet valve 46, the inner surface of the tapered wall 20, and the back 50 allows liquid to flow from the cartridge into the back and around the outlet valve, possibly out of the jet opening 52. It is supposed to be even possible.
(Operation of the embodiment of FIGS. 1 to 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 FIG. 1, and then the wall 18 of the cartridge 12 as shown by the solid line in FIG. The cartridge 12 is completely pushed into the nozzle until the tapered portion 20 contacts the cartridge contact 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 previous initial pressure position in the throat 21 of the cartridge 12, as shown in FIGS. With the valve in this position, the liquid disposed in the cartridge is prevented from flowing out of the throat 21 by the body portion 58 of the valve 46.
[0016]
The ram 44 in the injector 32 is held stationary so that when the cartridge / nozzle assembly 10 is inserted into the injector 32, the pressure of the plunger 24 against the liquid disposed in the cartridge 12. Moves the outlet valve 46 to the front initial pressurizing position shown in FIG. Since the outlet valve 46 has the slot 56, the liquid in the cartridge can flow through the cartridge throat 21 and into the cartridge inner portion 50. The front valve channel 64 of the outlet valve 46 allows liquid to flow rapidly into the back 50 and displace any air in the back 50 and expel that air from the orifice channel 54 and orifice 52. The back, the orifice channel, and the opening are completely filled with injectable material. This can also cause some injected material to drip from the jet orifice, but it is of little importance because 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 impossible without knowing the amount of air entering the front of the nozzle. This also allows the pressure to be accurately scheduled, which is impossible if the amount of air entering the front of the nozzle cannot be determined.
[0017]
The step of inserting the cartridge / nozzle assembly 10 into the injector 32 is typically performed immediately prior to injection. Thus, with the assembly 10 installed, the needleless injector 32 is driven, pushing the ram 44 and plunger 24 forward, thereby moving the injected material through the slot 56 into the outlet valve 46 and the back 50. Flows around the body 58 disposed therein, through the valve channel 64, into the open channel 54 and 52, and into the patient. Due to the configuration of the outlet valve 46, the throat 21 and the inner wall of the inner portion 50, the liquid is pushed out of the cartridge and the ejection opening, and a slight pressure drop occurs.
(Embodiment of FIGS. 11, 12A and 12B)
11, 12A and 12B show one alternative embodiment of a prefilled cartridge / nozzle assembly, generally designated as 110. FIG. Embodiment 110 has an elastomeric membrane at the outlet valve location, which is designed to rupture and open when given pressure, as shown in FIGS. 12A and 12B. Has been. The thin film 166 typically has a fragile portion where rupture occurs. In the depicted embodiment, the fragile portion is in the form of a notch 167 extending around 360 ° but not all of the throat 121 inside the cartridge 112. The membrane 166 is held in place by an aluminum seal 168 that is often used to help seal the cartridge that typically contains the drug.
[0018]
The other part of embodiment 110 has an O-ring 122 and a nozzle 114 and is generally similar to embodiment 10 in that it is generally pre-filled with injectable material. 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. Designed. With the membrane 166 ruptured, the injected material flows into the back 155 of the front end of the nozzle 114, thereby moving any air and the assembly is ready for injection.
(Embodiment of FIGS. 13A and 13B)
FIGS. 13A and 13B illustrate another alternative embodiment of a cartridge / nozzle assembly, generally designated as 210. FIG. This embodiment uses an aluminum seal 268 as in embodiment 110, but also has an outlet valve 246. The outlet valve 246 has a pair of radially extending vanes 270 that are clamped under the aluminum seal 268 to a predetermined pressure sufficient to push the outlet valve 246 out of the inner throat 221 of the cartridge 212. It is done. When this predetermined pressure is reached, the vanes 270 are withdrawn from the seal 268 and the valve advances into the back 250 of the nozzle 214 until it contacts the nozzle abutment surface 248.
[0019]
Except for the presence of vanes 270, the outlet valve 246 is similar to the outlet valve 46 described above in the cartridge / nozzle assembly 10 of FIGS. Thus, when the outlet valve 246 moves to its forward position shown in FIG. 13B, the injected material flows out of the cartridge 212 and flows into the back 250, and any air moves, so the assembly 210 is injected as described above. Prepare for.
(Embodiment of FIGS. 14A-C)
The cartridge / nozzle assembly 310 of FIGS. 14A-C is equivalent to the assembly 210 except that the vane 370 of the outlet valve 346 has a weakened portion. In the illustrated embodiment, these weak portions are in the form of a pair of notches 372. Thus, when the cartridge / nozzle assembly 310 is attached to a needleless injection system (not shown), instead of the vane 370 being pulled out of engagement with the seal 368, the vane generally splits from the notch 372 and the outlet valve is shown in FIG. It becomes possible to move to the forward position shown by 14C. Other aspects of operation of the cartridge / nozzle assembly 310 are similar to the assemblies 10 and 210 described above.
(Embodiment of FIGS. 15, 16A and 16B)
The cartridge / nozzle assembly 410 of FIGS. 15, 16A and 16B is equivalent to the assembly 10 of FIGS. 1-10, except that the back 450 of the nozzle 414 has a plurality of equally spaced ribs 474. is there. In the depicted embodiment, four such ribs 474 are provided. These are sized such that the outlet valve 446 fits securely into the back 450 as shown in FIG. 16B. Channels 476 defined between the ribs 474 allow liquid to flow from the periphery of the outlet valve 446 to the orifice 52. In other respects, the cartridge / nozzle assembly 410 is configured and operates in the same manner as the assembly 10 of FIGS.
(Embodiment of FIGS. 17A and 17B)
FIGS. 17A and B illustrate another alternative embodiment of a cartridge / nozzle assembly, generally designated as 510. FIG. The assembly includes a cartridge 512 and a nozzle 514. The cartridge 512 is pre-filled with the injecting material as described above, and is sealed with an aluminum seal 568 and an elastomer 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 immediately before injection. A plastic spike seal 580 is provided adjacent to the spike to prevent leakage of the injected material. The assembly 510 is then attached to the needleless infusion system as described above and air is transferred to prepare the unit for infusion.
[0020]
In other respects, the cartridge / nozzle assembly is configured and operated in a manner similar to the previously described embodiments.
(Embodiment of FIGS. 18-22)
Figures 18-22 illustrate another alternative embodiment of the cartridge / nozzle assembly. The assembly generally shown as 610 includes a cartridge 612 and a nozzle 614. FIG. 18 shows the assembly 610 threaded onto the needleless injector 632. The injector 632 is the same as the injector 32 described above except for the attachment by the screw. Also shown in FIG. 18 is an anti-contamination cap 633. This cap is attached to cover the front end of the nozzle 614 prior to use to prevent contamination of the nozzle orifice 652 and contamination of the infusion material contained in the cartridge / nozzle assembly 610.
[0021]
The depicted anti-contamination cap 633 is shown to be airtight. However, the cap 633 should be understood as allowing air and / or infused material to escape from the nozzle orifice 652 when hydraulic pressure is applied. Thus, as described below, when the cartridge / nozzle assembly is attached to the injector 632, air and some of the injected material will leak through the cap 633. Alternatively, the cap can 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 infused material from the nozzle during the attachment process. Good.
[0022]
The cartridge 612 is typically made of tempered glass and is pre-filled with a liquid injecting material. The illustrated nozzle 614 is formed of a high strength thermoplastic, typically polycarbonate. The cartridge 612 has an outer wall 618 that is slightly inclined at a front portion 620 thereof. The tapered wall 620 converges to form an internal throat 621 at the front end of the cartridge 612. An O-ring seal 622 is disposed adjacent to the taper portion of the cartridge 612 between the cartridge and the nozzle sidewall 630, which is the front side thereof. In other words, the positioning of the O-ring 622 is disposed between the outer surface (outer wall 618) of the cartridge and the inner surface of the nozzle adjacent to 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 in the nozzle, the O-ring 622 prevents or at least reduces the flow of injected material along the interface between the outer surface of the cartridge wall 618 and the inner surface of the nozzle side wall 630, and is suitable. Maintain the high pressure required for needleless injection.
[0023]
A plunger 624 is disposed in the wall 618 of the cartridge 612 and controls the flow of infusate from the cartridge as desired by the operator. In a factory where the drug is aseptically filled (in an aseptic environment), the cartridge 612 is inserted into the nozzle 614 and pushed forward as shown in FIG. It is pushed completely into the nozzle until it abuts the cartridge abutment surface 626 at the end. In this specification, the cartridge contact surface 626 is sometimes called an interface surface extending to the side.
[0024]
As best shown in FIG. 19, an outlet valve 646 is initially disposed in the throat 621 adjacent the front end of the cartridge 612. In the illustrated embodiment, the outlet valve 646 is configured in a spherical shape and is a PTFE (polytetrafluoroethylene) or other elastic material suitable for storage of chemicals and prior to insertion into the cartridge 612. It is formed from what can be sterilized. As shown in FIG. 19, the outlet valve 646 is designed to fit securely within the front end of the cartridge 612. Valve 646 is configured in a spherical shape, and in a preferred embodiment does not have any slots or openings therein, and is sized to fit securely within throat 621 of cartridge 612. Thus, it may be said that it has a body that fits against the wall of the cartridge throat 621, which prevents the infusate from flowing out of the cartridge until the valve 646 is pushed out of the cartridge throat.
[0025]
In the preferred embodiment, the outlet valve 646 has an outer diameter of 0.110 inches, and the throat 621 has an inner diameter of 0.098 inches. This dimensional difference allows for a friction fit to the front end of the cartridge 612 by accompanying some elastic properties of the PTFE or other material from which the outlet valve 646 is formed. Indeed, if the outlet valve 646 is configured to be more elliptical than that shown in FIGS. 18 and 19, the fact is that the inner diameter of the throat 621 is smaller than the diameter of the outlet valve 646. Once hydraulic pressure acts 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 is pushed forward. This typically occurs when assembly 614 is screwed into the receiving screw of injector 632. This screwing step causes the plunger 624 to be pushed slightly outward or forward (right side in FIG. 18), and thus the outlet valve 646 is likewise pushed forward. The front end of the valve receiving cup 647 terminates with a jet orifice 652 having a nozzle orifice channel 654 that is generally conical. In this specification, the valve receiving cup 647 is sometimes referred to as the back of the nozzle.
[0026]
To facilitate the flow of infusate from the cartridge 612 through the jet orifice 652, a plurality of bypass channels 649 are provided. a , b as well as c Are formed on the valve receiving cup 647 and the valve contact surface 648. These include that the injecting substance is placed between the valve and the channel through the channel when the outlet valve 646 is in any position of the valve receiving cup 647 or in the position facing the valve abutment surface 648. It is sized sufficiently to provide sufficient clearance to allow diversion out of channel 654 and out of jet orifice 652. In a preferred embodiment, the diameter of the outlet valve 646 is 0.110 inches and the valve receiving cup is approximately 0.115 in diameter, with the valve channel being 0.150 inches in diameter measurement, or the valve receiving cup. From the center of the channel to the end of this channel. 075 inches. Three bypass channels 649 a , b , c Are used, each channel is approximately 45 ° wide, and the channels are equally spaced, where each center line is 120 ° apart. Of course, other channel configurations can be used, or other configurations can be substituted that allow liquid to pass through the outlet valve and into the orifice channel.
[0027]
When the plunger 624 is pushed slightly forward, the pressure of the liquid injection material in the cartridge 612 pushes the outlet valve 624 out of the throat 621 into the valve receiving cup 647 and against the valve abutment surface 648. . Accordingly, the liquid injecting material can be used in the valve receiving cup 647 and the channel 649. a , 649 b And 649 c , Fills nozzle orifice channel 654 and drips from nozzle orifice 652. Because the anti-contamination cap 633 is in place, when the assembly 610 is screwed into place in the injector 632, this will cause leakage of the injected material from the cap.
[0028]
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 infusate out of the orifice 652 and into the patient (not shown).
[0029]
In other respects, the cartridge / nozzle assembly 610 is similar to that of the embodiment of FIGS.
(Operation of the embodiment of FIGS. 18 to 22)
The cartridge 612 is inserted into the nozzle 614 at a factory location where aseptic conditions are ensured. In such an insertion process, the cartridge 612 is pushed forward and pushed completely into the nozzle until the front end of the cartridge contacts the cartridge abutment surface 626 at the front end of the nozzle. This position is shown in FIG. Because the injected material 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, an outlet valve 646 disposed in the throat 621 securely seals the cartridge, preventing the injected material from leaking out of the cartridge and preventing contamination of the injected material. Anti-contamination cap 633 (shown only in FIG. 18 and attached to the injector after assembly) helps prevent contamination.
[0030]
When the user is ready to dispense, the assembly 610 is removed from its bag or sterile bag and screwed into the front end of the syringe, as shown at 632 in FIG. When this screwing is complete, the plunger 624 is pushed forward because the injection ram 644 is stationary in the injector. This pushes the outlet valve 646 out of the cartridge throat 621 and into the valve receiving cup 647 against the valve abutment surface 648. Thus, the injected material fills all the air space at the tip of the nozzle, causing air and a small amount of injected material to escape from the cap 633.
[0031]
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 and the nozzle is positioned against the patient's skin to operate the injector.
[0032]
In other respects, the operation of the cartridge / nozzle assembly 610 is essentially similar to that of the assembly 10 shown in FIGS.
[0033]
Modifications and improvements of the present invention may be made without departing from the spirit and scope of the invention. Such changes and modifications are intended to cover the following claims.
[Brief description of the drawings]
FIG. 1 is a side cross-sectional view of a prefilled cartridge according to the present invention, showing an initial position before insertion of the cartridge by a broken line and an insertion position before initial pressurization by a solid line.
FIG. 2 is a cross-sectional end view taken along line 2-2 in 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 a preferred embodiment of the needleless injection system.
4 is a partially enlarged side cross-sectional view of the outlet valve and adjacent portion of the cartridge / nozzle assembly of the embodiment of FIG. 1, showing the outlet valve in a non-pressurized position.
FIG. 5 is a view corresponding to FIG. 4 except that the outlet valve is shown in cross section and moved to a forward position.
6 is an enlarged side view of the outlet valve of the embodiment of FIG. 1. FIG.
7 is a side cross-sectional view taken along line 7-7 in FIG.
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 an end cross-sectional view taken along line 9-9 of FIG. 4, showing the rear portion of the outlet valve.
FIG. 10 is an isometric view of the outlet valve of FIGS.
FIG. 11 is a side cross-sectional view of an alternative embodiment showing a thin film as a substitute for an outlet valve.
12A is a side cross-sectional view when the thin film of the embodiment of FIG. 11 is torn.
FIG. 12B is an isometric view corresponding to FIG. 12A.
FIG. 13A is a side cross-sectional view when the outlet valve of the second alternative embodiment is in its closed position.
FIG. 13B is a view corresponding to FIG. 13A except that the outlet valve in its forward position is shown.
FIG. 14A shows an outlet valve corresponding to the outlet valve shown in FIGS. 13A and B, except that the valve blades 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 cuts in the vanes is shown.
FIG. 14C corresponds to FIG. 14B, except that the outlet valve in its open position is shown.
FIG. 15 is a partial side cross-sectional view of yet another alternative embodiment of the nozzle with the cartridge or outlet valve removed, showing the inner rib 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.
FIG. 16B is a view corresponding to FIG. 16A, except that the outlet valve in its forward position is shown.
FIG. 17A is a side view of an alternative embodiment of the present invention.
FIG. 17B is a diagram corresponding to that of FIG. 17A.
FIG. 18 is a side cross-sectional view showing the location of the cartridge and nozzle in the alternative embodiment shown in FIGS.
FIG. 19 is a side cross-sectional view of the embodiment of FIG. 18 when the plunger is in its rearward position prior to attachment of the assembly to the injector.
20 is an end cross-sectional view taken along line 20-20 in FIG.
FIG. 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 infusate is injected from the assembly.
22 is a cross-sectional end view taken along line 22-22 in FIG. 21. FIG.
[Explanation of symbols]
10 Cartridge / nozzle assembly
12 cartridges
14 nozzles
16 Protrusion
18 Cartridge wall
20 Tapered wall
21 Internal throat
22 O-ring
24 Plunger
26 Cartridge contact surface
30 side walls
32 Needleless injection system
38 space
40 Inside
42 Contact surface
44 Lamb
45 Teflon (registered trademark) pad
46 Outlet valve
48 Valve contact surface
50 back
52 Jet orifice
54 Orifice channel
56 circular slots
58 body
64 Valve channel
110 Cartridge / Nozzle Assembly
112 cartridges
114 nozzles
121 Throat
122 O-ring
166 thin film
167 notch
168 Aluminum seal
210 Cartridge / Nozzle Assembly
212 cartridges
214 nozzles
221 Internal throat
246 Outlet valve
250 back
248 Nozzle contact surface
268 Aluminum seal
270 feathers
310 Cartridge / Nozzle Assembly
346 Outlet valve
368 seal
370 feathers
372 notch
410 Cartridge / Nozzle Assembly
414 nozzle
446 Outlet valve
450 back
474 ribs
476 channels
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 Exterior wall
620 taper wall
621 Internal throat
622 O-ring
624 Plunger
626 Cartridge contact surface
630 Nozzle side wall
632 Needleless injector
633 Anti-contamination cap
644 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

Claims (16)

A cartridge and nozzle assembly for use in a needleless injection system comprising:
A cartridge having a plunger disposed at a rear end thereof and including an inner portion having a throat at a front portion thereof, and further including an interface surface extending substantially laterally;
A movable outlet valve disposed from the beginning in the throat and having a channel-free valve body;
A nozzle for receiving the cartridge;
A seal disposed behind the interface surface between the cartridge and the nozzle to at least reduce leakage of the injected material from between the cartridge and the nozzle;
The nozzle defines a rear cartridge receiving portion and has a front portion defining a valve receiving portion having a plurality of channels and a single injection orifice defined therein, the outlet valve comprising: The front is configured to receive the valve when the valve is moved to a forward position, such as when moved from the throat to a valve receiving portion of the nozzle, An assembly wherein the inner portion further comprises a generally laterally extending interface surface that advances liquid through the channel to the orifice and abuts the interface surface of the cartridge.   The assembly of claim 1, wherein the throat of the cartridge is tapered and the seal is mounted adjacent to the throat of the cartridge in a gap defined between the cartridge and the nozzle. .   The assembly of claim 1, wherein the valve receiving portion of the nozzle is in the form of a back having a valve abutment surface having the channel defined therein.   4. The assembly of claim 3, wherein the channel has a portion extending substantially axially in the interior of the nozzle.   The assembly of claim 1, wherein the outlet valve has a smooth and regular surface.   The assembly of claim 5, wherein the outlet valve is rounded.   The assembly of claim 6, wherein the outlet valve is substantially spherical.   The assembly of claim 7, wherein the outlet valve is resilient.   The assembly of claim 8, wherein the cartridge is formed from glass. A cartridge including an inner portion having a plunger disposed at the rear end and having a throat at the front thereof;
A movable outlet valve disposed from the beginning in the throat of the cartridge further comprising a generally outwardly facing surface;
A system for selectively supplying a driving force for driving the plunger forward;
A nozzle for receiving the cartridge;
The outer facing surface of the cartridge and the nozzle of the nozzle to at least reduce leakage of infusate from between the outward facing surface of the cartridge and the inward facing surface of the nozzle. A seal disposed between the inwardly facing surface;
With
The nozzle defines a rear cartridge receiving portion and terminates at a valve abutment surface having a plurality of channels and a single injection orifice defined therein, and a front portion defining the same. And the valve is disposed forward so that the valve is disposed opposite the valve abutment surface for the inner portion of the cartridge to advance liquid to the orifice through the channel. A needleless infusion device further comprising a generally inwardly facing surface that is configured to receive the valve when moved to a position and abuts the surface of the cartridge. The needleless injection device according to claim 10, wherein the valve contact surface has a cup shape. The needle-free injection device according to claim 11, wherein the outlet valve is rounded at least at a front end. The needle-free injection device according to claim 12, wherein the outlet valve has a substantially spherical shape. The needle-free injection device according to claim 1, wherein the outlet valve has elasticity. A method of making a needleless injection system,
A glass having a plunger that can be positioned at the rear end, an inner portion having a throat at the front, and an outlet valve that can be positioned in the throat, and further having a substantially laterally extending interface surface Select the cartridge
Positioning a seal behind the laterally extending interface surface of the cartridge;
One of the plunger and the outlet valve is positioned in the cartridge;
Prior to positioning the other of the plunger and the outlet valve in the cartridge, the cartridge is filled with infusate,
Positioning the other of the plunger and outlet valve in the cartridge;
A rear cartridge receiving portion and a front portion defining a valve receiving portion having a plurality of channels and an injection orifice therein, the front portion when the valve is moved to a forward position. The nozzle is further configured to receive the valve, and selects a nozzle further having an interface surface extending substantially laterally;
A method of mounting the cartridge in the nozzle so that the interface surface is adjacent and the seal is disposed behind such an adjacency to form a cartridge / seal assembly.   16. The method of claim 15, further comprising positioning an anti-contamination cap on the front side of the nozzle.

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