Source: http://www.google.com/patents/US5865799?dq=7,603,356
Timestamp: 2017-11-19 17:19:08
Document Index: 32132747

Matched Legal Cases: ['arts 3', 'art 3', 'arts 3', 'arts 3', 'art 3', 'art 3', 'art 3', 'arts 3', 'arts 3', 'art 3', 'art 3', 'art 3', 'art 3']

Patent US5865799 - Prefilled syringe - Google Patents
A prefilled syringe capable of separate storage of different substances before use. It includes a tubular body having an injection needle at one end and a plunger at the other end, and a partition axially slidable in the tubular body. The partition includes a front part and a rear part independent of...http://www.google.com/patents/US5865799?utm_source=gb-gplus-sharePatent US5865799 - Prefilled syringe
Publication number US5865799 A
Application number US 08/899,053
Also published as CA2094660A1, CA2094660C, CN1080874A, CN1095680C, DE69319495D1, DE69319495T2, EP0568321A2, EP0568321A3, EP0568321B1, US5605542, US5716339, US5817056
Publication number 08899053, 899053, US 5865799 A, US 5865799A, US-A-5865799, US5865799 A, US5865799A
US 5865799 A
A prefilled syringe capable of separate storage of different substances before use. It includes a tubular body having an injection needle at one end and a plunger at the other end, and a partition axially slidable in the tubular body. The partition includes a front part and a rear part independent of each other, and as a whole divides the interior space of the tubular body into a front compartment and a rear compartment in a sealing manner for storing mutually different substances. A bypass is disposed generally between the front and rear compartments to introduce the substance in the rear compartment into the front compartment when the partition is slid under pressure provided by the plunger to be adjacent to the bypass to thereby mix the substances immediately prior to injection.
1. A prefilled syringe for storing at least two substances apart from each other and subsequently mixing the substances in the syringe prior to injection, said prefilled syringe comprising:
a tubular body having front and rear end portions and front and rear compartments, each of said compartments having one of the at least two substances therein, and said rear end portion being sealed by a plunger that is adapted to be axially slid in the tubular body by a push rod;
a bypass stopper plug that is axially slidable in said tubular body and disposed between said front and rear compartments for separating and sealing said front and rear compartments from each other and for sliding by being actuated by sliding of said plunger, said stopper plug having an axial thickness and a front section;
a bypass between said stopper plug and said front end portion of said tubular body for permitting one of the substances in one of said front and rear compartments to bypass said stopper plug so as to be introduced into the other of said front and rear compartments, said bypass having an axial length greater than the axial thickness of said stopper plug, and said stopper plug being slidable to said bypass by sliding of said plunger;
a double-pointed needle having a front end for injection and a rear piercing end, said needle being engagable with said front end portion of said tubular body; and
a front plug for sealing said front end portion of said tubular body, said front plug having a front central recess for guiding said rear piercing end of said needle into said front plug;
wherein said stopper plug has a front central recess axially aligned with said front central recess of said front plug for housing said rear piercing end of said needle after said needle has pierced said front plug.
2. A prefilled syringe for storing at least two substances apart from each other and subsequently mixing the substances in the syringe prior to injection, said prefilled syringe comprising:
a bypass stopper plug that is axially slidable in said tubular body and disposed between said front and rear compartments for separating and sealing said front and rear compartments from each other and for sliding by being actuated by sliding of said plunger, said stopper plug having an axial thickness and a front end;
a double-pointed needle having a front end for injection and a rear piercing end, said needle being engagable with said front end portion of said tubular body;
a front plug for sealing said front end portion of said tubular body, said front plug having a front central recess for guiding said rear piercing end of said needle into said front plug and a rear end; and
another central recess in one of said stopper plug and said front plug that is axially aligned with said front central recess of said front plug for housing said rear piercing end of said needle after said needle has pierced said front plug;
wherein said front end of said stopper plug is convex and said rear end of said front plug is concave, said stopper plug and said front plug engaging each other after the substances have been injected.
3. The prefilled syringe of claim 2, wherein the other said central recess is disposed in said front end of said stopper plug.
4. The prefilled syringe of claim 2, wherein the other said central recess is disposed in said rear end of said front plug.
5. A prefilled syringe for storing at least two substances apart from each other and subsequently mixing the substances in the syringe prior to injection, said prefilled syringe comprising:
a bypass stopper that is axially slidable in said tubular body and disposed between said front and rear compartments for separating and sealing said front and rear compartments from each other and for sliding by being actuated by sliding of said plunger, said bypass stopper comprising a first stopper plug and a second stopper plug, said first stopper plug being located in front of said second stopper plug, and said bypass stopper having an axial thickness;
a bypass between said bypass stopper and said front end portion of said tubular body for permitting one of the substances in one of said front and rear compartments to bypass said bypass stopper so as to be introduced into the other of said front and rear compartments, said bypass having an axial length greater than the axial thickness of said bypass stopper, and said bypass stopper being slidable to said bypass by sliding of said plunger;
another central recess in one of said first stopper plug and said front plug that is axially aligned with said front central recess of said front plug for housing said rear piercing end of said needle after said needle has pierced said front plug.
6. The prefilled syringe of claim 5, wherein the other said central recess is disposed in said rear end of said front plug.
This is a Rule 60 Divisional application of Ser. No. 08/530,674, filed Sep. 19, 1995, now U.S. Pat. No 5,716,339, which is a Divisional of Ser. No. 08/052,622, filed Apr. 27,1993, now abandoned.
Since a powdery medicinal component tends to become unstable in the presence of water, it is essential to dry out at least the side of the partition 33 facing the front compartment 34 which contains a desiccated powdery injection, component. It is common practice to dry the syringe at a temperature of 100° C. or more for hours, but this high temperature unfavorably affects the vehicle L in the rear compartment 35. As a result, this high temperature heat-drying method cannot be adopted.
It is common practice to provide the partition 33 with annular or ring-shaped ribs 33a along the periphery so as to reduce friction between the parition 33 and the inside wall of the body 33. In this case, they unavoidably form one or more ring-shaped grooves (G) therebetween. These grooves (G) trap the injection liquid when the injection liquid is ejected from the rear compartment 35 to the front compartment 34 so that the injection liquid remains unused in the grooves (G). Specifically, the injection liquid is pushed axially through the bypass 36, but the ribs 33a catch some of the liquid through the bypass 36 and divert it circumferentially into the grooves (G) where it is trapped and remains unused. This results in waste of the injection liquid.
In order to solve this problem, applicants have considered indicia or markings at an appropriate position on the plunger where the plunger is to be stopped. This marking method encounters the difficulty of restraining the plunger from axial movement relative to the tubular body while the mixing is effected by swinging the syringe. Besides, attention must be constantly paid to the marking while the rod is pushed. The conventional prefilled syringe has no device which has solved this problem.
According to another aspect of the present invention, the prefilled syringe includes a tubular body having a front end closable by a plug and adapted to accept an injection needle and a rear end closable by a plunger with a rod which is movable in the tubular body. A movable partition divides the interior space of the tubular body into a front compartment and a rear compartment in a sealing manner, the front compartment storing a first substance and the rear compartment storing a second substance. The partition includes circumferentially extending ring-shaped first ribs along the periphery thereof, with a ring-shaped groove interposed therebetween, and second transverse ribs for bridging and subdividing the groove into small recesses. The second ribs having the same height as of the ring-shaped first ribs. A bypass is also produced in the front compartment so as to introduce the second substance into the front compartment therethrough when the partition is moved into the front compartment under pressure provided by the plunger, thereby effecting a predetermined action, such as dispersing or dissolving between the first and second substances in the front compartment.
This invention may be better understood, and its numerous objects and advantages will become apparent to those skilled in the art, by reference to the accompanying drawings,
FIG. 12 is a cross-section through a modified version of the example of FIG. 10 in which a partition and a plunger have ring-shaped ribs and bridging ribs;
Referring to FIG. 1, the exemplary prefilled syringe has a generally tubular body 1 which is open at the front and rear ends, and a plunger 2 having a push rod slidably inserted into the body 1 through the rear end. The push rod may be detachable. The body 1 includes a front compartment 4 and a rear compartment 5 separated by a partition or sealing means 3 in a liquid-tight manner, the partition 3 being slidable axially in the body 1 under pressure provided by the plunger 2. The front compartment stores a medicinal component P as a powder, microcapsules, granules, tablets, and liquids, or any other form or state, and the rear compartment 5 stores a vehicle L in a liquid or any other form for dissolving or dispersing the medicinal component P, or for becoming mixed therewith. The body 1 is provided with a bypass 6 on the inside wall thereof. The bypass or bypass means 6 is produced in the form of a recess for introducing the vehicle L in the rear compartment 5 into the front compartment 4, which will be described in detail.
The partition 3 includes a front part or portion or bypass stopper or stopper plug 3a and a rear part or portion or bypass stopper or stopper plug 3b which are independent of each other and separately movable. Each of the partition parts or stoppers 3a, 3b extends radially and the inner walls of the body 1 to seal the rear compartment 5 from the front compartment 4 independently of the other partition part with which it is paired. The combined axial length of the partition parts 3a, 3b is less than the axial length of the bypass 6 and permit the injection liquid to be conveyed from the rear compartment 5 to the front compartment 4. When the partition 3 is between the bypass 6 and the rear end of the syringe, the partition parts preferably engage each other, but if they are slightly spaced because of air being compressed therebetween when the they are front part 3a is slid into the body during assembly, the axial distance of such a space is less than the axial width of one of the partition parts 3a and 3b. In use, as the plunger 2 is initially pushed, the air between the partition parts 3a and 3b is compressed by the movement of the rear part 3b. This compression urges the front part 3a forward until the rear face of the front partition part 3a reaches the bypass 6, whereupon any air between the partition parts 3a and 3b escapes therefrom to the bypass 6 to permit the partition parts 3a and 3b to engage each other if not already engaged. It is in this engaged state in which the partition 3 travels the remainder of the syringe.
The front end portion 1a of the body 1 is closed by a movable plug 7. As described below in detail, the front end 1a of the syringe is capped with a cap carrying an injection needle. Herein, the front, end portion of the syringe, covers the front end of the syringe and a further portion extending slightly toward the bypass 6 from the front end of the syringe. Hereinafter, the front end portion of the syringe may be referred to as the "front end of the syringe". It should be noted that the plug 7, before actuation of the plunger, may be spaced from the extreme front end of the syringe to minimize the chances that the plug 7 will prematurely slide out of the front end. The distance that the plug 7 is spaced from the extreme front end may depend upon the volume of the substances to be mixed. Such a volume may define the space between the bypass 6 and the plug 7, and hence the distance between the plug 7 and the extreme front end.
FIG. 9 shows a modification to the example of FIG. 8, characterized in that the plug 7 is provided with a recess 7a in the concave surface, the recesses 7a and 7b being aligned with each other, with the front part 3a of the partition 3 having no recess. The recess 7a in this modification functions like the recess 7a as described with respect example of FIG. 5.
This example is designed to assist a stirring action of the medicinal component P and vehicle L after such are initially mixed in the front compartment so as to obtain a homogeneous injection liquid through a predetermined chemical state, such as dispersing or dissolving, as the case may be. The stirring is facilitated by a swinging of the syringe. In this case, it is difficult to retain the plunger 2 at an appropriate place when the injection liquid is in the front compartment; if the plunger 2 is moved excessively into the tubular body 1, the medicinal component P and vehicle L are likely to be injected through the syringe without reaching a homogeneous state. To solve this difficulty, the tubular body 1 is provided with a disc-shaped fingergrip 100 at the end of the tubular body 1 into which the plunger 2 is inserted. The fingergrip 100 has an inner peripheral rim or syringe portion 101 projecting slightly into the passage for the plunger 2. The plunger 2 has a rod 20 which is provided with projections or nubs 201 on the periphery thereof; in the exemplary embodiment, four projections 201 are displaced at 90° around the axis of the plunger 2. Each of the nubs 201 extends in a radial and axial direction. The nubs 201 are axially spaced from the rim 101 such that the plunger 2 freely slides through the rear compartment 5. The nubs 201 are also axially spaced from the rear end of the push rod so that the plunger 2 slides freely through the front compartment 4. Each projection 201 is located at such a position that it comes into engagement with the inner peripheral rim 101 when the forward end or face of the front part 3a of the partition 3 reaches the outlet or front side (left-hand side) of the bypass 6 as shown in FIG. 13(B) such that the bypass is almost or in fact is shut off relative to the front compartment 4 to minimize or prevent backflow to the bypass 6. At this position, the rear compartment 5 is completely sealed by the plunger 2 to prevent backflow into the push rod region during a shaking of the syringe. It should be noted that the syringe is conservatively constructed so that, even if the push rod 2 is pushed slightly past the nubs 201, the plunger still seals the bypass inlet.
An alternative example is shown in FIGS. 14(A) to 14(E). This example is characterized by the provision of slots 102 in the inner peripheral rim or syringe portion 101. The illustrated example has four slots 102 displaced at 90°. The rod 20 of the plunger 2 is provided with a number of blades 202 corresponding to that of the slots 102 so that the blades 202 can fit into the slots 102. The blades 202 have a size to permit passage through the respective slots 102 after the push rod 20 has been rotated or turned to match the blades 202 to their respective slots 102. The length from the central axis of the rod 20 up to the top edge of each blade 202 is slightly larger than the inside diameter of the peripheral resilient rim 101 so as to enable each blade 202 to fit in the respective slots 102. The forward end or engagement portion of each blade 202 is axially spaced from the inner peripheral resilient rim 101 before the plunger 2 is actuated. The forward end of each blade 202 is positioned so that each blade 202 can come into engagement with the rear end face of the fingergrip 100 when the forward end of the front part 3a of the partition 3 reaches the left-band side of the bypass 6 as shown in FIG. 14(D) such that the front compartment 4 is almost or in is fact is sealed relative to the bypass 6 to prevent backflow into the bypass 6. At this position, the plunger 2 also seals the rear compartment 5 against backflow from the bypass 6.
In using the syringe, the rod 20 is pushed until the front ends of the blades 202 come into engagement with the rear end face of the finger grip 100 as shown in FIG. 14(c), which shows the relationship between the blades 202 and the slots 102. The rod 20 is thus prevented from further entering the tubular body 1 when the of the syringe creates a centrifugal force on the plunger 2 and rod 20. At this position, as shown in FIG. 14(D), the front part 3a of the partition 3 has reached the left-hand side of the bypass 6 to almost or in fact shut off the bypass 6, and the vehicle L in the rear compartment 5 has completely entered the front compartment 4 as the plunger 2 has engaged the rear stopper. Then the syringe is swung so as to enable the medicinal component P and vehicle L to mix into a homogeneous injection liquid through a predetermined action, such as dispersing or dissolving, as the case may be. Finally the plunger 2 is turned or rotated and again pushed so as to enable the blades 202 to pass through the slots 102 as shown in FIG. 14(E). In this way the injection liquid is ejected through the syringe in a homogeneously mixed state.
US8679072 * Apr 26, 2012 Mar 25, 2014 DePuy Synthes Products, LLC Bone-regeneration material
US20120209172 * Apr 26, 2012 Aug 16, 2012 Synthes Usa, Llc Bone-Regeneration Material
WO2002076534A1 * Mar 26, 2002 Oct 3, 2002 Laboratoire De Contactologie Appliquee-Lca Syringe for visco-elastic solutions
Cooperative Classification A61M5/315, A61M5/31505, A61M2005/3132, A61M5/31513, A61M5/31511, A61M5/284, A61M5/31596
European Classification A61M5/315, A61M5/315C, A61M5/28M, A61M5/315M