JP2003516195A - Syringe with retractable needle assembly - Google Patents

Abstract

(57) Abstract: A disposable, single use syringe having a hollow body, a retractable needle assembly located inside the hollow body, and a plunger assembly inside the hollow body. The plunger assembly includes an elongated frame portion having at least one guide track between its ends. The retraction member is releasably secured to one end of the frame and a catch member having a catch end is positioned by a guide member configured to move within the plunger frame guide track. An elastic member extends between the retraction member and the catch member. The retaining assembly is at the opposite end of the plunger frame and is configured to receive and secure the catch end, thereby exerting tension on the resilient member. The needle assembly and the retraction member have complementary mating members. Thereby, when the needle assembly and the retraction member are fitted, the tension of the elastic member is released, and the injection means is retracted into the hollow body. A manufacturing method is also disclosed.

Description

Detailed Description of the Invention

TECHNICAL FIELD The present invention relates generally to protection from accidental cuts and punctures from unprotected needles. More particularly, the present invention relates to retractable needle syringes (needle syringes) for protection against accidental cuts and punctures from used syringes of the type commonly associated with medical practice. More particularly, the present invention relates to an automatic retractable needle syringe for protection against accidental cuts and punctures from used syringes.

BACKGROUND ART [0002] Recently, it has been recognized that it is necessary to protect a person from inadvertent cuts and punctures of an injection needle. Moreover, very recently there has been interest in the potential for serious and life-threatening infections as a result of such accidents. In addition, a recent trend is that many states are considering legislation requiring the use of safe needle technology, awaiting approval from the Occupational Safety and Health Administration. However, although the need to protect against accidental cuts and punctures from blades and needles has been recognized, practical protective equipment is not yet available.

In US Pat. No. 5,209,739, both are retractable (retractable).
A hypodermic needle assembly including a cannula and a syringe are disclosed. An elastomer tube is connected between the cannula and the passageway to the fluid chamber. In order to retract the cannula into the second compartment in each example, the user must independently operate a separate mechanical device. Since fluid must pass through the elastomeric tube and bypass to the second compartment, there is a potential risk that air will be directly injected into the patient if the elastomeric tube fails.

EP 0 862 A1 discloses a device in which a needle is to be retracted into a syringe. In some embodiments of this instrument, the user must independently operate a mechanical instrument to retract the needle. In one embodiment using an elastic member, the user has to depress the plunger to stress the elastic member because the elastic member is not preloaded. After that, it is necessary to continue to apply pressure to the plunger so that the return of the plunger does not start too early. Therefore, both hands are required to operate this instrument.

Various methods of providing a prestressed, one-handed retractable assembly are disclosed in co-owned PCT Application No. PCT / US97 / 20646 and International Application No. WO 98/20923. . Although these devices work well, the retractable members are in prestressed condition due to tension, so their storage life (
Shelf life) can be somewhat shorter.

Other devices have been introduced to allow the user to apply a load to the retractable member. However, these instruments generally require complex and specialized procedures to do this. As operations become less commonplace, they generally become unacceptable in the medical field. Moreover, some of these instruments require mechanical adjustment of the instrument. This adjustment can be difficult to make or can cause deformations that preclude normal operation of the instrument. See, for example, US Pat. Nos. 5,928,200 and 5,836,917 in this regard.

In addition, many retractable systems use retractable members that have a geometric structure (configuration) that mates with (matches) the geometrical members of the needle assembly. The common problem with these is that the retracting member with a geometric structure is in front of the plunger sealing surface (sealing surface, sealing surface), so that it penetrates the needle assembly before all fluid is expelled. Engaging with the passage to seal it. As a result, the pressure inside the syringe body rises. As the needle assembly is retracted, the fluid passageway is opened and pressurized fluid is expelled therefrom.

Another problem with prior art devices is that the manufacturing process is complicated and expensive. Due to the sheer volume of syringes and other needle devices used in the medical field, a substantial increase in product cost is undesirable and generally unacceptable.

DISCLOSURE OF THE INVENTION Accordingly, there is a need for a syringe with a self-retracting used needle assembly that can be used in conventional ways and is not complicated to manufacture.

The present invention relates to a disposable, single-use syringe having a hollow body, a retractable needle assembly located inside the hollow body, and a plunger assembly inside the hollow body. The plunger assembly has an elongate frame portion that extends between a sealing platform and a catch platform and defines at least one guide track located between the platforms.
The sealing platform is in sealing engagement with the hollow body. The retracting member is releasably (removably) secured to the sealing platform and the catch member with the catch tip is arranged with a guide configured to move within a guide track of the plunger frame. To be done. An elastomeric member extends between the retraction member and the catch member. The retention assembly is configured to hang from the catch platform and receive and secure the catch tip, thereby tensioning the elastomeric member.
Is activated. The needle assembly and retracting member have complementary mating members (matching members). This relieves the tension of the elastomeric member as the needle assembly and retracting member are mated and the injection means is retracted within the hollow body. Manufacturing methods are also provided.

(Best Mode for Carrying Out the Invention) A preferred embodiment will be described with reference to the drawings. Note that the reference numerals represent the same elements throughout.

The components of the preferred embodiment of the present invention will be described with reference to FIG. The syringe assembly 8 generally includes a cap member 10 and a syringe barrel 4
0, the needle assembly 70, and the plunger assembly 100.

The cap member 10 has an open mating end 12 and a closed cone 14. The mating end 12 is preferably configured for sliding engagement with the syringe barrel 40. Alternatively, mating end 12 may be provided with threads (not shown) that can engage corresponding threads (not shown) on syringe barrel 40. Other caps and corresponding outer cylinder shapes are well known, and these may be used. The closed cone 14 preferably has a plurality of ribs 16 that aid in gripping the cap member 10.

Referring to FIGS. 2 and 3, the syringe barrel 40 includes a closed end 44 and an open end 5.
And a hollow body portion 42 having An outer stable gripping member 56 extends from the hollow body 42 in front of it near the open end 54. The gripping member 56 may have various shapes, but preferably has the oval shape shown. An inner annular shoulder 60 is formed in hollow body portion 42 at approximately the same location as gripping member 56. The open end 54 forms an open recess 58 behind the inner annular shoulder 60. An inner annular lip 62 may be provided near the open end 54.

The closed end 44 is defined by a truncated cone 46 that includes a truncated plane having an opening 48. As will be described in detail below, there is a retaining groove 50 within the hollow body 42 near the closed end that holds the needle assembly 70 in place during use.
Referring to FIG. 3, the closed end near the truncated cone 46 has a generally convex taper 47 and at least one internal ramp 52 whose function will be described later.

Referring to FIG. 4, the needle assembly 70 has a needle 72 centrally located within a conical protrusion 74. The conical protrusion 74 fits the entire inside of the truncated cone 46 of the syringe outer barrel 40. The sealing ring (sealing ring,
There is a sealing ring) 76. The protrusion 74 and the sealing ring 76 are formed as a single molded product of synthetic rubber. The internal passage 78 of the needle assembly 70 includes a hollow needle 72 and a cavity 8 of geometric structure extending to the back surface of the needle assembly 70.
Communicate with 0. In the preferred embodiment, the cavity 80 has a cylindrical portion 80a and a hemispherical portion 80b that mate with the geometrical tip 176 of the plunger mandrel 170. Needle assembly 70 includes needle 72 extending through opening 48 and
Located within the syringe barrel 40 such that the sealing ring 76 is positioned and retained by the retaining groove 50.

Referring to FIGS. 1 and 5 to 11, the plunger assembly 100 includes a plunger frame 110, a retraction assembly 160, a thumb pad 104, and a sealing member (sealing member) 150. The plunger frame 110 has a sealing end 130 and a retaining end 11 having a pair of opposing connecting rods 126 extending therebetween.
4 and. The counter connecting rod 126 defines a guide track 128 of the counter retracting assembly.

The sealing end (sealing end) 130 includes an opening base (shelf with openings) 132 extending between the connecting rods 126, and an opening pressure cone 138 extending from the opening base 132.
And an open cylindrical portion 134 terminating at. As for the opening, the continuous opening 140 is the base 13
It is preferably concentric so that the sealing end 130 can be passed from 2 to the pressure cone 138. The opening 140 has a diameter greater than that of the inside of the pressure cone 138, and the base 132
It is preferable that the inside of the taper has a large taper. Further, an inner annular ring 142 extends into the opening 140 near the pressure cone 138. An outer annular retaining ring 136 is positioned around the junction of cylinder 134 and pressure cone 138. The function of these taper, inner and outer rings 142, 136 will be described in detail below.

Referring to FIG. 6, the retaining end 114 of the plunger frame 110 has a termination plate 116 extending between and bridging the opposing connecting rods 126. An annular thumb pad retaining ring 117 extends around the end plate 116. Furthermore,
A guide member 118 may extend outwardly from each connecting rod 126 near the end plate 116. Retaining assembly 120 extends inwardly from end plate 116 between opposing connecting rods 126. The preferred retaining assembly 120 comprises a pair of opposed L-shaped members 122 each having a bevel catch 124 extending therefrom. Other retention assemblies that allow inward passage and then retention of the tip of the geometric structure are also within the scope of the invention.

Each component of the plunger frame 110 is preferably made of polypropylene or glass filled polypropylene. Other materials may be used, including various plastics. Plunger frame 110, in addition to the components of retraction assembly 150, is preferably formed as the first shot of a multiple shot injection molding process, as described in detail below.

Referring to FIG. 8, the plunger sealing member 150 is located around the cylinder 134 and the outer retaining ring 136 and is held in place by the outer retaining ring 136. The sealing member (sealing member, sealing member) 150 comprises annular seals 152 and 154 at each end with a narrow portion 156 therebetween. When the plunger assembly 100 is positioned in the syringe barrel 40, the annular seal 152 seals against the inner surface of the hollow body portion 42 with an open space area around the narrow portion 156 (
Engage in a sealed state). The annular seal 154 may also be sealingly engaged (engaged in a sealed manner) with the hollow body 142, but may also have a passage in the narrow portion 156 to prevent a vacuum from being created. The sealing member 150 is preferably made of an elastomer.
A usable material is Kraton® manufactured by Shell Oil Company.
A preferred material is Kraton® G2706 manufactured by Shell Oil Company. As will be described in more detail below, the sealing member 150 is preferably overmolded directly in place, but may be separately manufactured and placed around the cylinder 134 and the retaining ring 136.

The retaining end 114 of the plunger frame 110 may be used with only the termination plate 116. However, it is preferable to provide the thumb pad 104, which is retained by the retaining ring 117, around the end plate 116, as shown in FIG.
The thumb pad 104 is also preferably made of an elastomer, preferably Kraton. With respect to the sealing member 150, the thumb pad 104 is preferably overmolded directly in place, but may be separately manufactured and placed and secured around the end plate 116.

A suitable retraction assembly 160 will be described with reference to FIGS. 8, 10 and 11. The retracting assembly 160 has a mandrel 170, a catch plate 190 and an elastic member 164. Referring to FIG. 10, the mandrel 170 has a generally cylindrical body 172 with a tapered portion 174 extending from one end and a shaft portion 180 extending from the other end. The tapered portion 174 is the tip 17 of the geometric structure.
Terminate at 6. A mandrel annular retaining ring 178 extends around the cylindrical body 172 near the juncture with the tapered portion 174. The shaft portion 180 has a plurality of plate-shaped protrusions 182 extending to hold the elastic member 164. Referring to FIG. 8, an annular stop 184 extends around the cylindrical body 172 near the end of the shaft. Stop 184 is preferably elastomeric and, therefore, preferably formed associated with elastic member 164.

Referring to FIGS. 5 and 11, the catch plate 190 is the elongated plate 1.
92, the elongated plate 192 is sized so that each end of the plate 192 extends into and moves within a respective retraction assembly guide track 128 of the plunger frame 110. Has been. Extending from one side of the elongated plate 192 is a shaft 194 with a plate-like protrusion 196 extending therefrom to retain the elastic member 164. A second shaft 198 extends from the opposite side of the elongated plate 192 and terminates in a geometrical catch tip 200. The tip portion 200 has a holding assembly 1 for the plunger frame 110.
20 and adapted to be retained by the retaining assembly 120.

The mandrel 170 and the catch plate 190 are preferably made of the same material as the plunger frame 110. Thus, these components can be formed during the first shot of the multiple shot injection molding process used to form the plunger frame 110.

The elastic member 164 extends between the mandrel 170 and the catch plate 190.
The elastic member 164 is preferably an elastomer, but is made from an elastic material that may be other materials such as stainless steel springs. The elastic member 164 is
It is preferably manufactured in Kraton. In the preferred manufacturing method described below, the elastic member 164 is formed between the mandrel 170 and the catch plate 190 by a second injection overmolding shot. Due to the fact that the elastic member 164 is overmolded directly on the tabbed shafts 180 and 194 and due to the inherent adhesive properties of suitable materials, the elastic member 164 is fixed to the mandrel 170 and the catch plate 190. There is no need for additional fixing means such as glue to hold the. The elastic member 164 is also manufactured individually regardless of the manufacturing material thereof.
It may be fixed to 70 and the catch plate 190. Sealing member 150, thumb pad 104, and stop 184 are preferably all made of the same material as elastic member 164 so that they are formed during the second injection overmolding shot. Is preferred.

Having described the preferred components of the syringe 8, its assembly and use will now be described with reference to FIGS. 12-19. Needle assembly 70 has opening 4
8 is located within a syringe barrel 40 with a needle member (needle) 72 extending therethrough. The needle assembly 70 includes a sealing ring (sealing ring, sealing ring).
The syringe body 76 is inserted until it is fitted and held in the syringe body holding groove 50. The cap member 10 may mate with the closed end 44 of the syringe barrel 40 either before or after insertion of the needle assembly 70.

The plunger assembly 100 includes a plunger frame 110 having a thumb pad 104 and a sealing member 150 already located thereon, and a retraction assembly 16.
It is assembled by assembling 0 and. As mentioned above, the elastic member 164 is preferably molded directly on the mandrel 170 and the catch plate 190, thereby forming the retraction assembly 160. When not integrally formed, the elastic member 164 is provided on the shaft portion 18 of the mandrel and the plate of the catch plate.
It is fixed with respect to 0,194. Once the retracting assembly 160 is complete, the mandrel 170 is inserted through the opening 140 through the plunger frame sealing end 130. The mandrel 170 includes an inner annular ring 14 with a mandrel retaining ring 178 at the sealed end.
It is inserted until it is fixed by 2. The mandrel retaining ring 178 includes a pressure cone 1
38 with the plunger sealing end 130 near 38 to form a fluid tight seal
0 is sealed. The elastic stop 184 abuts the back surface of the sealing platform 132 to form a fluid tight seal around this end of the opening 140. A vacuum is created as the plunger assembly is withdrawn from the hollow body portion 42. The seal formed by the elastic stop 184 prevents internal vacuum forces from drawing air or other substances through the mandrel 170 and into the hollow body portion 42.

With the mandrel 170 in place, the plunger assembly 100 is ready for insertion into the syringe barrel 40 through the open end 54. Annular seals 152 and 154 sealingly engage with the interior of syringe barrel 40 when plunger assembly 100 is inserted. As shown in FIG. 12, the plunger assembly 100 is inserted approximately halfway into the syringe barrel 40 until the elongated plate 192 abuts the shoulder 60. The syringe 8 is ready for packaging and shipping. At this point, the elastic member 164 is under tension.
Note that does not work. Since the elastic member 164 is not in a constant tension state, it is useful for extending the storage life (shelf life) of the syringe 8.
If shelf life is not an issue, the catch plate 190 may be secured to the retaining assembly 120 prior to packaging, in which case the elastic members of the syringe 8 will have prestress.

After removing the syringe assembly 8 from the packaging, the user can hold the syringe by the typical one-handed method, with two fingers on the gripping member 56 and a thumb resting on the thumb pad 104. . The user depresses thumb pad 104 almost completely, thus pushing plunger assembly 100 into syringe barrel 40 to expel air from syringe hollow body portion 42. This is similar to standard syringe operation. When the plunger assembly 100 is pushed, the elongated plate 19
2, and thus the catch plate 190 is also held by the shoulder 60 and the catch plate 190 cannot be advanced. However, the plunger frame 110 continues to advance. Although the catch plate 190 is held, the plunger frame 11
As the 0 and fixed mandrel 170 continue to advance, elastic member 164 expands and tension begins to act. As shown in FIG. 13, as the advancement continues, the catch tip 200 of the catch plate geometry will move toward the plunger frame 1.
10 is retained in mating engagement with retaining assembly 120. Thereby, the elastic member 16
4 is in a state in which a load is applied by receiving tension between the fixed mandrel 170 and the fixed catch plate 190. Tip 200 and retaining assembly 1
A "click" sound may be generated when mating with 18 to provide an appropriate fit signal to the user. In the preferred embodiment, the syringe barrel annular lip 62 at this time near the open end prevents complete depression of the plunger assembly 100.

When the elastic member 164 is loaded, as shown in FIG. 14, the cap 10 is removed, the needle member (needle) 72 is inserted into a desired vial, and the plunger assembly 100 is pulled out. The syringe 8 can be filled in the conventional manner of withdrawing the desired dose. The elastic member 164 is under tension between the two components secured to the plunger frame 110 so that withdrawing the plunger assembly 100 does not result in movement of the elastic member 164 (not triggered). . Thus, the plunger assembly 100 operates as a standard syringe plunger.

When air is expelled from the syringe barrel 40 in a known manner, the needle member (needle) 72 of the device (device) 8 is ready for insertion into the patient. As mentioned above, since the elastic member 164 is pulled between the two fixing elements, the elastic member 164 does not act to move the plunger assembly 100 in either direction.
Therefore, the user does not have to maintain a constant pressure on the plunger assembly, so that the syringe 8 is freely held in a conventional dirt-like manner between the thumb and index finger of one hand while the other The hand can pinch the patient's skin at the site of subcutaneous injection insertion, spread the skin for intramuscular injection, or press the skin for IV injection. These injection methods are generally preferred in the medical field. When the needle member 72 is inserted, the backward force indicated by the arrow A in FIG.
Join the needle assembly 70. However, the needle assembly sealing ring (needle assembly sealing ring, needle assembly sealing ring) 7
6 is sufficiently fixed in the holding groove 50. Further, since the syringe barrel taper surface 47 around the truncated cone 46 is convex, the rearward force is as indicated by arrow B:
The syringe barrel surface is urged inward, which creates a stronger holding force around the needle assembly 70. After the user inserts the needle member 72 into the patient, the user depresses the thumb pad 104 to inject the drug into the patient.

As shown in FIG. 16, when the plunger assembly 100 is substantially pushed down,
The mandrel tip 176 begins to enter the needle assembly cavity 80. At approximately the same time, the first annular seal 152 causes the ramp 52 near the closed end 44 of the syringe barrel 40.
The fluid resistant seal is destroyed by being deformed (deflected) by the inclined portion 52 in contact with. Any fluid trapped between the plunger sealing member 150 and the needle assembly 70 is passed through the deformed annular seal 152 into the open space around the narrow portion 156. The second annular seal 154 may remain in sealing engagement with the syringe barrel 40 to prevent any unwanted inward or outward flow through the sealing member 150. However, the annular seal 154 may include small passages around the narrow portion 156 to allow trapped air to escape.

The mandrel tip 176 passes through the needle assembly cavity cylindrical portion 80a and into the geometrical cavity sealing portion 80b, as shown in FIG. Thereby, the mandrel 170 is fixed to the needle assembly 70. In this position, the mandrel tip 176 moves as far as possible within the needle assembly 70, but the plunger frame 110 does not move this full stroke. Therefore, the force exerted on the thumb pad 104 continues to move the plunger frame 110 forward. The position of the mandrel 170 is fixed and the plunger frame 110 receives a forward force. Accordingly, the mandrel retaining ring 178 receives an inward force past the plunger seal end retaining ring 136, thereby releasing the mandrel 170, as shown in FIG. That is, the mandrel retaining ring 178 moves to the rear (rear) of the retaining ring 136, as shown in phantom. The mandrel 170 has an elastic member 164.
Of the elastic member 164 causes the mandrel 170 to automatically retract into the plunger frame 110 between the connecting rods 126 as it is under the load of the elastic member 164 and is no longer held by the retaining ring 136. Get caught As shown in FIG. 19, the needle assembly 70 is retracted into the plunger frame 110 through the connection between the mandrel tip 176 and the geometrical needle assembly cavity 80. Tapered pressure cone 138 at the sealed end of plunger frame 110
Contacts the convex tapered portion 47 on the truncated cone 46 and causes it to expand slightly. As a result, the holding force of the truncated cone 46 on the needle assembly 70 is reduced to assist the retraction of the needle assembly 70. Further, since the tapered portion 47 has a convex shape, the force of the advancing fluid and the plunger shown by the arrow C in FIG.
The tapered portion 47 is squeezed outward, as shown by, and the holding force further decreases and the required retraction force decreases. This bending (deflection, bending) preferably occurs at the same time as the mandrel 176 enters the sealing portion 80a of the needle assembly cavity 80, or shortly thereafter.

Referring again to FIG. 19, as the plunger assembly 100 travels the full stroke, the thumb pad 104 enters the open cavity 58 at the end of the syringe barrel 40. In the preferred embodiment, the thumb pad 104 is made of a resilient material that sealingly engages the syringe barrel 40 so that the open end 54 is closed to prevent accidental outflow of fluid out of the syringe barrel 40. To prevent. Additionally, the thumb pad 104 enters and is housed within the open cavity 58, reducing the likelihood of accidental or intentional removal of the plunger assembly 100 exposing the used needle member 72. Thumb pad 10
4 preferably has a semi-dome shape for ease of removal. In addition, the thumb pad 104 is preferably adapted to be inserted and retained over the inner annular lip, making it more difficult to remove.

A preferred manufacturing method will be described with reference to FIGS. 20 and 21. Using the first shot injection molding process, the components of the plunger frame 110 (retaining end 114,
The sealing ends 130 and the connecting rods 126) extending therebetween, the mandrel 170, and the catch plate 190 are formed by a single shot of the desired material, which is polypropylene in the preferred embodiment. The components (components) obtained are shown in FIG. Axle 170 and catch plate 190 provide elements 170, 19
It is held in place with respect to each other and with respect to the plunger frame 110 by runners 210 extending from 0 to the connecting rod 126. The formed plunger frame 110, mandrel 170, and catch plate 190 are then transferred into the second molding cavity. As shown in FIG. 21, the kraton (
A second injection molded overmold shot of the desired material, which is a registered trademark), is used to force the elastic member 164, the stop 184, the sealing member 150, and the thumb pad 104 into contact with each other.
It is formed directly on the corresponding parts of the plunger frame 110, the mandrel 170 and the catch plate 190. After the plunger assembly 100 is removed from the second molding, the runner 210 is removed from the mandrel 170 and the connecting rod 126, freeing the mandrel 170. The mandrel 170 is then pushed through the hollow shaft 140 at the plunger sealing end until it is held in place by the interaction of the mandrel retaining ring 178 and the retaining ring 136 at the plunger sealing end. After the mandrel 170 has been fixed, the runner 210 has a catch plate 190 and a connecting rod 12.
It can be detached between 6 and. Although it is possible to remove all runners 210 at the same time, hold the runner 210 that supports the catch plate 190,
It is preferred to avoid moving the retraction assembly 160 too far during insertion of the mandrel 170. With the mandrel 170 inserted and the runner 210 removed, the plunger assembly 100 is ready for use in accordance with the above.

This method of overmolding the elastic elastomeric material around the frame assembly can be used to mold a variety of other medical and non-medical products. With regard to medical products, retractable blood collection devices, automatic lancets, syringes with inner or outer elastomeric sheaths that have or may have tension, and butterfly devices and the like are contemplated.

Although the present invention has been described in terms of a preferred embodiment, various other modifications within the scope of the invention as defined by the claims will be apparent to those skilled in the art.

[Brief description of drawings]

FIG. 1 is an enlarged view of a syringe assembly (syringe assembly) according to the present invention.

FIG. 2 is a sectional view of a preferred syringe barrel.

3 is an exploded view of the closed end of the syringe barrel of FIG.

FIG. 4 is a side view of the needle assembly.

FIG. 5 isometric of a preferred plunger assembly of the present invention.
view).

6 is a cross-sectional view of the plunger frame of the plunger assembly of FIG.

7 is an exploded view of a sealing end portion (sealing end portion, sealing end portion) of the plunger frame of FIG.

8 is a cross-sectional view of the plunger assembly of FIG. 5 taken along line 8-8.

9 is an exploded view of the retaining end of the plunger assembly of FIG.

FIG. 10 is a side view of a preferred mandrel of the present invention.

FIG. 11 is a side view of a preferred catch plate of the present invention.

FIG. 12: Suitable syringe (syringe) in an assembled state and an unused state
FIG.

FIG. 13 is a view of FIG. 12 during initial substantial depression of the plunger assembly.
It is a figure which shows the syringe of FIG.

14 shows the syringe of FIG. 12 after filling the syringe.

FIG. 15 shows the front portion of the syringe of FIG. 12 when the syringe is inserted into a patient.

FIG. 16 shows the front portion of the syringe of FIG. 12 with the plunger assembly substantially depressed.

FIG. 17 shows the anterior portion of the syringe of FIG. 12 after the mandrel tip has entered the cavity of the needle assembly.

18 shows the front portion of the syringe of FIG. 12 when the plunger assembly is fully depressed.

FIG. 19 shows the syringe of FIG. 12 after retracting (after retracting) the needle assembly.

FIG. 20 is a diagram of a plunger assembly member formed by a first injection molding shot according to a preferred manufacturing method.

FIG. 21 is a diagram of a plunger assembly formed by a second injection overmolding shot according to a preferred manufacturing method.

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] March 19, 2002 (2002.19)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Correction target item name] Full text

[Correction method] Change

[Contents of correction]

Title: Syringe with retractable needle assembly

[Claims]

Detailed Description of the Invention

TECHNICAL FIELD The present invention relates generally to protection from accidental cuts and punctures from unprotected needles. More particularly, the present invention relates to retractable needle syringes (needle syringes) for protection against accidental cuts and punctures from used syringes of the type commonly associated with medical practice. More particularly, the present invention relates to an automatic retractable needle syringe for protection against accidental cuts and punctures from used syringes.

BACKGROUND ART [0002] Recently, it has been recognized that it is necessary to protect a person from inadvertent cuts and punctures of an injection needle. Moreover, very recently there has been interest in the potential for serious and life-threatening infections as a result of such accidents. In addition, a recent trend is that many states are considering legislation requiring the use of safe needle technology, awaiting approval from the Occupational Safety and Health Administration. However, although the need to protect against accidental cuts and punctures from blades and needles has been recognized, practical protective equipment is not yet available.

In US Pat. No. 5,209,739, both are retractable (retractable).
A hypodermic needle assembly including a cannula and a syringe are disclosed. An elastomer tube is connected between the cannula and the passageway to the fluid chamber. In order to retract the cannula into the second compartment in each example, the user must independently operate a separate mechanical device. Since fluid must pass through the elastomeric tube and bypass to the second compartment, there is a potential risk that air will be directly injected into the patient if the elastomeric tube fails.

European Patent No. 0 480 862 A1 discloses a device in which an injection needle is to be retracted into a syringe. In some embodiments of this instrument, the user must independently operate a mechanical instrument to retract the needle. In one embodiment using an elastic member, the user has to depress the plunger to stress the elastic member because the elastic member is not preloaded. After that, it is necessary to continue to apply pressure to the plunger so that the return of the plunger does not start too early. Therefore, both hands are required to operate this instrument.

Further, French Patent No. 2,673,844 is a device in which a user applies a load to an elastic member by pressing the plunger (pushing in), and the plunger is not careless afterwards. Disclosed is a device that requires continued pressure on the plunger to avoid premature withdrawal.

[0006] Various methods of providing a prestressed, one-handed retractable assembly are disclosed in co-owned PCT Application No. PCT / US97 / 20646 and International Application No. WO 98/20923. . While these devices work well, the retractable assembly is in prestressed condition under tension, which can result in somewhat shorter shelf life.

Other devices that allow a user to apply a load to the retracting assembly
Has been introduced. However, these instruments generally require complex and specialized procedures to do this. As operations become less commonplace, they generally become unacceptable in the medical field. Moreover, some of these instruments require mechanical adjustment of the instrument. This adjustment can be difficult to make or can cause deformations that preclude normal operation of the instrument. This point, for example,
See U.S. Pat. Nos. 5,928,200 and 5,836,917.

In addition, many retractable systems use retractable members that have a geometry that matches (matches) the geometry of the needle assembly. The common problem with these is that the retracting member with a geometric structure is in front of the plunger sealing surface (sealing surface, sealing surface), so that it penetrates the needle assembly before all fluid is expelled. Engaging with the passage to seal it. As a result, the pressure inside the syringe body rises. As the needle assembly is retracted, the fluid passageway is opened and pressurized fluid is expelled therefrom.

Another problem with the prior art devices is that the manufacturing process is complicated and expensive. Due to the sheer volume of syringes and other needle devices used in the medical field, a substantial increase in product cost is undesirable and generally unacceptable.

DISCLOSURE OF THE INVENTION Accordingly, there is a need for a syringe with a self-retracting used needle assembly that can be used in conventional ways and is not complicated to manufacture.

The present invention relates to a disposable, single-use syringe having a hollow body, a retractable needle assembly located inside the hollow body, and a plunger assembly inside the hollow body. The plunger assembly has an elongate frame portion extending between the sealing end and the catch platform and defining at least one guide track located therebetween. The sealing end is in sealing engagement with the hollow body (engages in a sealed state). A mandrel (retracting member) is releasably (removably) fixed to the sealed end, and a catch member having a catch tip is configured to move within a guide track of the plunger frame ( Guide) is arranged. A flexible member, preferably an elastomeric member, is made up of the mandrel (
(Mandrill) and the catch member. The retention assembly is configured to hang from the catch platform and receive and secure the catch tip, thereby exerting tension on the flexible member. The needle assembly and mandrel have complementary mating members (matching members). This relieves tension on the flexible member as the needle assembly and mandrel mate and the injection means is retracted inside the hollow body. Manufacturing methods are also provided.

(Best Mode for Carrying Out the Invention) A preferred embodiment will be described with reference to the drawings. Note that the reference numerals represent the same elements throughout.

The components of the preferred embodiment of the present invention will be described with reference to FIG. The syringe 8 generally includes a cap member 10, a syringe barrel 40, a needle assembly 70, and a plunger assembly 100.

The cap member 10 has an open mating end 12 and a closed cone 14. The mating end 12 is preferably configured for sliding engagement with the syringe barrel 40. Alternatively, mating end 12 may be provided with threads (not shown) that can engage corresponding threads (not shown) on syringe barrel 40. Other caps and corresponding outer cylinder shapes are well known, and these may be used. The closed cone 14 preferably has a plurality of ribs 16 that aid in gripping the cap member 10.

Referring to FIGS. 2 and 3, the syringe barrel 40 includes a closed end 44 and an open end 5.
And a hollow body 42 having The outer stable gripping member 56 has the open end 5
4 extends from the hollow body 42 in front of it. The gripping member 56 may have various shapes, but preferably has the oval shape shown. Internal annular shoulder 60
Is formed in the hollow body portion 42 at substantially the same position as the grip member 56. The open end 54 forms an open recess 58 behind the inner annular shoulder 60. Internal annular lip 6
2 may be provided near the open end 54.

The closed end 44 is defined by a truncated cone 46 that includes a truncated plane having an opening 48. As will be described in detail below, there is a retaining groove 50 within the hollow body 42 near the closed end that holds the needle assembly 70 in place during use.
Referring to FIG. 3, the closed end near the truncated cone 46 has a generally convex taper 47 and at least one internal ramp 52 whose function will be described later.

Referring to FIG. 4, the needle assembly 70 has a needle 72 centrally located within a conical protrusion 74. The conical protrusion 74 fits the entire inside of the truncated cone 46 of the syringe outer barrel 40. The sealing ring (sealing ring,
There is a sealing ring) 76. The protrusion 74 and the sealing ring 76 are formed as a single molded product of synthetic rubber. The internal passage 78 of the needle assembly 70 includes a hollow needle 72 and a cavity 8 of geometric structure extending to the back surface of the needle assembly 70.
Communicate with 0. In the preferred embodiment, the cavity 80 has a cylindrical portion 80a and a hemispherical portion 80b that mate with the geometrical tip 176 of the plunger mandrel 170. Needle assembly 70 includes needle 72 extending through opening 48 and
Located within the syringe barrel 40 such that the sealing ring 76 is positioned and retained by the retaining groove 50.

Referring to FIGS. 1 and 5 to 11, the plunger assembly 100 includes a plunger frame 110, a retraction assembly 160, a thumb pad 104, and a sealing member (sealing member) 150. The plunger frame 110 has a sealing end 130 and a retaining end 11 having a pair of opposing connecting rods 126 extending therebetween.
4 and. The counter connecting rod 126 defines a guide track 128 of the counter retracting assembly.

The sealing end (sealing end) 130 includes an opening base (shelf with openings) 132 extending between the connecting rods 126, and an opening pressure cone 138 extending from the opening base 132.
And an open cylindrical portion 134 terminating at. As for the opening, the continuous opening 140 is the base 13
It is preferably concentric so that the sealing end 130 can be passed from 2 to the pressure cone 138. The opening 140 has a diameter greater than that of the inside of the pressure cone 138, and the base 132
It is preferable that the inside of the taper has a large taper. Further, an inner annular ring 142 extends into the opening 140 near the pressure cone 138. An outer annular retaining ring 136 is positioned around the junction of cylinder 134 and pressure cone 138. The function of these taper, inner and outer rings 142, 136 will be described in detail below.

Referring to FIG. 6, the retaining end 114 of the plunger frame 110 has a catch platform 116 extending between and bridging the opposing connecting rods 126. Annular thumb pad retaining ring 117 provides catch platform 116.
Extend around. Further, the guide member 118 is provided with a catch platform 116.
It may extend outward from each connecting rod 126 in the vicinity. Retaining assembly 120 extends inwardly from catch platform 116 between opposing connecting rods 126. A preferred retention assembly 120 includes bevel catches 1 each extending therefrom.
A pair of opposing L-shaped members 122 having 24 are provided. Other retention assemblies that allow inward passage and then retention of the tip of the geometric structure are also within the scope of the invention.

Each component of the plunger frame 110 is preferably made of polypropylene or glass filled polypropylene. Other materials may be used, including various plastics. Plunger frame 110, in addition to the components of retraction assembly 160, is preferably formed as the first shot of a multiple shot injection molding process, as described in detail below.

Referring to FIG. 8, the plunger sealing member 150 is located around the cylinder 134 and the outer retaining ring 136 and is held in place by the outer retaining ring 136. The sealing member (sealing member, sealing member) 150 comprises annular seals 152 and 154 at each end with a narrow portion 156 therebetween. When the plunger assembly 100 is positioned in the syringe barrel 40, the annular seal 152 seals against the inner surface of the hollow body portion 42 with an open space area around the narrow portion 156 (
Engage in a sealed state). The annular seal 154 may also be sealingly engaged (engaged in a hermetically sealed manner) with the hollow body 42, but may also have a passageway in the narrow portion 156 to prevent a vacuum from being created. The sealing member 150 is preferably made of an elastomer. A usable material is Kraton® manufactured by Shell Oil Company. A preferred material is Kraton® G2706 manufactured by Shell Oil Company. As will be described in more detail below, the sealing member 150 is preferably overmolded directly in place, but is preferably manufactured separately and has the cylinder 134 and the retaining ring 1.
It may be arranged around 36.

The retaining end 114 of the plunger frame 110 is attached to the catch platform 1
Only 16 may be provided and used. However, as shown in FIG. 9, the retaining ring 117
A thumb pad 104 retained by is preferably provided around the catch platform 116. The thumb pad 104 is also preferably made of an elastomer, preferably Kraton. With respect to the sealing member 150, the thumb pad 104
Are preferably overmolded directly in place, but may be separately manufactured and placed and secured around catch platform 116.

A suitable retraction assembly 160 is described with reference to FIGS. 8, 10 and 11. The retracting assembly 160 has a mandrel 170, a catch member 190 and a resilient member 164. Referring to FIG. 10, the mandrel 170 has a generally cylindrical body 172 with a tapered portion 174 extending from one end and a shaft portion 180 extending from the other end. Tapered portion 174 terminates in a geometrical tip 176. A mandrel annular retaining ring 178 extends around the cylindrical body 172 near the juncture with the tapered portion 174. The shaft portion 180 has a plurality of plate-shaped protrusions 182 extending to hold the elastic member 164. Referring to FIG. 8, an annular stop 184 extends around the cylindrical body 172 near the end of the shaft. Stop 184 is preferably elastomeric and, therefore, preferably formed associated with elastic member 164.

Referring to FIGS. 5 and 11, the catch member 190 may include the catch plate 1.
92, which has a catch plate 192.
Each of the ends of each of the plungers 110 is sized to extend into and move within a respective retraction assembly guide track 128 of the plunger frame 110.
Extending from one side of the catch plate 192 is a shaft 194 with a plate-like protrusion 196 extending therefrom to retain the elastic member 164. A second shaft 198 extends from the opposite side of the catch plate 192 and terminates in a geometrical catch tip 200. The tip portion 200 is the plunger frame 11
It is configured to fit into and be held by zero holding assembly 120.

The mandrel 170 and the catch member 190 are preferably made of the same material as the plunger frame 110. Thus, these components can be formed during the first shot of the multiple shot injection molding process used to form the plunger frame 110.

The elastic member 164 extends between the mandrel 170 and the catch member 190. The elastic member 164 is preferably an elastomer, but is made from an elastic material that may be other materials such as stainless steel springs. The elastic member 164 is preferably manufactured from Kraton. In the preferred manufacturing method described below, the elastic member 164 is formed between the mandrel 170 and the catch member 190 by a second injection overmolding shot. The elastic member 164 is a shaft 180 with a plate-like protrusion.
And an additional adhesive or the like to hold the elastic member 164 secured to the mandrel 170 and the catch member 190, based on being overmolded directly on 194 and the inherent adhesive properties of suitable materials. There is no need for fixing means. The elastic member 164 may also be manufactured separately and fixed to the mandrel 170 and the catch member 190 regardless of the manufacturing material. Sealing member 150, thumb pad 104, and stop 184 are preferably all made of the same material as elastic member 164 so that they are formed during the second injection overmolding shot. Is preferred.

Having described the preferred components of the syringe 8, its assembly and use will be described with reference to FIGS. 12-19. Needle assembly 70 has opening 4
8 is located within a syringe barrel 40 with a needle member (needle) 72 extending therethrough. The needle assembly 70 includes a sealing ring (sealing ring, sealing ring).
The syringe body 76 is inserted until it is fitted and held in the syringe body holding groove 50. The cap member 10 may mate with the closed end 44 of the syringe barrel 40 either before or after insertion of the needle assembly 70.

The plunger assembly 100 includes a plunger frame 110 having a thumb pad 104 and a sealing member 150 already located thereon, and a retraction assembly 16.
It is assembled by assembling 0 and. As mentioned above, the elastic member 164 is preferably molded directly on the mandrel 170 and the catch member 190, thereby forming the retracting assembly 160. When not integrally formed, the elastic member 164 is fixed to the plate-shaped shaft portion 180 of the mandrel and the plate-shaped shaft portion 194 of the catch member. Retracting assembly 160
Once completed, mandrel 170 is inserted through opening 140 through plunger frame sealing end 130. The mandrel 170 is inserted until the mandrel retaining ring 178 is secured by the inner annular ring 142 at the sealed end. Mandrel holding ring 17
8 forms a fluid tight seal with the plunger sealing end 130 near the pressure cone 138 to seal the opening 140. The elastic stop 184 abuts the back surface of the sealing platform 132 to form a fluid tight seal around this end of the opening 140. A vacuum is created as the plunger assembly is withdrawn from the hollow body portion 42. The seal formed by the elastic stop 184 prevents internal vacuum forces from drawing air or other substances through the mandrel 170 and into the hollow body portion 42.

With the mandrel 170 in place, the plunger assembly 100 is ready for insertion into the syringe barrel 40 through the open end 54. Annular seals 152 and 154 sealingly engage with the interior of syringe barrel 40 when plunger assembly 100 is inserted. As shown in FIG. 12, the plunger assembly 100 is inserted almost halfway into the syringe barrel 40 until the catch plate 192 abuts the shoulder 60. The syringe 8 is ready for packaging and shipping. Note that tension (tension, stress) is not acting on the elastic member 164 at this point. Since the elastic member 164 is not in a constant tension state, it is useful for extending the storage life (shelf life) of the syringe 8. If shelf life is not an issue, the catch member 190 may be secured to the retaining assembly 120 prior to packaging, in which case the flexible member of the syringe 8 will have prestress.

After removing the syringe 8 from the packaging, the user can hold the syringe by the typical one-handed method, with two fingers on the gripping member 56 and a thumb resting on the thumb pad 104. The user depresses thumb pad 104 almost completely, thus pushing plunger assembly 100 into syringe barrel 40 to expel air from syringe hollow body portion 42. This is similar to standard syringe operation. When the plunger assembly 100 is pushed, the catch plate 192, and thus the catch member 190, is retained by the shoulder 60 and the catch member 19
0 cannot move forward. However, the plunger frame 110 continues to advance. Although the catch member 190 is retained, the plunger frame 110 and the fixed mandrel 170 continue to move forward, so that the elastic member 164 expands and tensions.
Begins to work. As shown in FIG. 13, as the advancement continues, the geometrical catch tip 200 is retained in mating engagement with the retaining assembly 120 of the plunger frame 110. As a result, the elastic member 164 is in a state in which a load is applied by receiving tension between the fixed mandrel 170 and the fixed catch member 190. As the catch tip 200 and retaining assembly 120 mate, a "click" may be generated to signal the user the proper fit. In the preferred embodiment, the syringe barrel annular lip 62 at this time near the open end prevents complete depression of the plunger assembly 100.

When the elastic member 164 is loaded, as shown in FIG. 14, the cap 10 is removed, the needle member (needle) 72 is inserted into a desired vial, and the plunger assembly 100 is pulled out. The syringe 8 can be filled in the conventional manner of withdrawing the desired dose. The elastic member 164 is under tension between the two components secured to the plunger frame 110 so that withdrawing the plunger assembly 100 does not result in movement of the elastic member 164 (not triggered). . Thus, the plunger assembly 100 operates as a standard syringe plunger.

Once the air has been expelled from the syringe barrel 40 in a known manner, the needle member 72 of the syringe 8 is ready for insertion into the patient. As described above, the elastic member 164
The elastic member 164 does not act to move the plunger assembly 100 in either direction because it is pulled between the two securing elements. Therefore, the user does not have to maintain a constant pressure on the plunger assembly, so that the syringe 8 is freely held in a conventional dirt-like manner between the thumb and index finger of one hand while the other The hand can pinch the patient's skin at the site of subcutaneous injection insertion, spread the skin for intramuscular injection, or press the skin for IV injection. These injection methods are generally preferred in the medical field. When the needle member 72 is inserted, the backward force indicated by the arrow A in FIG. 15 is applied to the needle assembly 70. However, the needle assembly sealing ring (needle assembly sealing ring, needle assembly sealing ring) 76 is
It is sufficiently fixed in the holding groove 50. Further, since the syringe barrel taper surface 47 around the frustoconical 46 is convex, the rearward force biases the syringe barrel surface inwardly, as indicated by arrow B, thereby causing the needle assembly 70 to move. Generates a stronger holding force around. After the user inserts the needle member 72 into the patient, the user depresses the thumb pad 104 to inject the drug into the patient.

As shown in FIG. 16, when the plunger assembly 100 is substantially pushed down,
The mandrel tip 176 begins to enter the needle assembly cavity 80. At approximately the same time, the first annular seal 152 causes the ramp 52 near the closed end 44 of the syringe barrel 40.
The fluid resistant seal is destroyed by being deformed (deflected) by the inclined portion 52 in contact with. Any fluid trapped between the plunger sealing member 150 and the needle assembly 70 is passed through the deformed annular seal 152 into the open space around the narrow portion 156. The second annular seal 154 may remain in sealing engagement with the syringe barrel 40 to prevent any unwanted inward or outward flow through the sealing member 150. However, the annular seal 154 may include small passages around the narrow portion 156 to allow trapped air to escape.

The mandrel tip 176 passes through the needle assembly cavity cylindrical portion 80a and into the geometrical cavity sealing portion 80b, as shown in FIG. Thereby, the mandrel 170 is fixed to the needle assembly 70. In this position, the mandrel tip 176 moves as far as possible within the needle assembly 70, but the plunger frame 110 does not move this full stroke. Therefore, the force exerted on the thumb pad 104 continues to move the plunger frame 110 forward. The position of the mandrel 170 is fixed, and the plunger frame 110 receives a forward force. Therefore, the mandrel retaining ring 178 receives an inward force past the plunger sealing end retaining ring 136, which results in a
Release the mandrel 170. That is, the mandrel retaining ring 178 moves to the rear (rear) of the retaining ring 136, as shown in phantom. The mandrel 170 includes the elastic member 16
4 under load, but no longer held by the retaining ring 136, the stress of the elastic member 164 causes the mandrel 170 to automatically into the plunger frame 110 between the connecting rods 126. Be drawn in. As shown in FIG. 19, the needle assembly 70 is retracted into the plunger frame 110 through the connection between the mandrel tip 176 and the geometrical needle assembly cavity 80. Tapered pressure cone 13 at the sealed end of plunger frame 110
8 contacts the convex taper portion 47 on the truncated cone 46 and causes it to expand slightly. As a result, the holding force of the truncated cone 46 on the needle assembly 70 is reduced to assist the retraction of the needle assembly 70. Further, since the tapered portion 47 is convex, the force of the advancing fluid and the plunger shown by the arrow C in FIG. 18 presses the tapered portion 47 outward as shown by the arrow D, and the holding force further decreases, which is necessary. Retractive force is reduced. This bending (deflection, bending) preferably occurs at the same time as the mandrel 176 enters the sealing portion 80a of the needle assembly cavity 80, or shortly thereafter.

Referring again to FIG. 19, as the plunger assembly 100 travels the full stroke, the thumb pad 104 enters the open cavity 58 at the end of the syringe barrel 40. In the preferred embodiment, the thumb pad 104 is made of a resilient material that sealingly engages the syringe barrel 40 so that the open end 54 is closed to prevent accidental outflow of fluid out of the syringe barrel 40. To prevent. Additionally, the thumb pad 104 enters and is housed within the open cavity 58, reducing the likelihood of accidental or intentional removal of the plunger assembly 100 exposing the used needle member 72. Thumb pad 10
4 preferably has a semi-dome shape for ease of removal. In addition, the thumb pad 104 is preferably adapted to be inserted and retained over the inner annular lip, making it more difficult to remove.

A preferred manufacturing method will be described with reference to FIGS. 20 and 21. Using the first shot injection molding process, the components of the plunger frame 110 (retaining end 114,
The sealing ends 130 and the connecting rod 126) extending therebetween, the mandrel 170, and the catch member 190 are formed by a single shot of the desired material, which is polypropylene in the preferred embodiment. Figure 2 shows the resulting components.
It shows in 0. The mandrel 170 and the catch member 190 are held in place with respect to each other and with respect to the plunger frame 110 by a runner 210 extending from the mandrel 170 and the catch member 190 to the connecting rod 126. The formed plunger frame 110, mandrel 170, and catch member 190 are then transferred into the second molding cavity. As shown in FIG. 21, the kraton (
A second injection molded overmold shot of the desired material, which is a registered trademark), is used to force the elastic member 164, the stop 184, the sealing member 150, and the thumb pad 104 into contact with each other.
It is formed directly on the corresponding parts of the plunger frame 110, the mandrel 170 and the catch member 190. After the plunger assembly 100 is removed from the second molding, the runner 210 is removed from the mandrel 170 and the connecting rod 126 and the mandrel 17 is removed.
0 becomes free. The mandrel 170 is then pushed through the hollow shaft 140 at the plunger sealing end until it is held in place by the interaction of the mandrel retaining ring 178 and the retaining ring 136 at the plunger sealing end. After the mandrel 170 is secured, the runner 210 can be removed between the catch member 190 and the connecting rod 126. Although it is possible to remove all runners 210 at the same time, retain the runner 210 that supports the catch member 190 to prevent the retraction assembly 160 from moving too much while inserting the mandrel 170. Is preferred. With the mandrel 170 inserted and the runner 210 removed, the plunger assembly 100 is ready for use in accordance with the above.

This method of overmolding the elastic elastomeric material around the frame assembly can be used to mold a variety of other medical and non-medical products. With regard to medical products, retractable blood collection devices, automatic lancets, syringes with inner or outer elastomeric sheaths that have or may have tension, and butterfly devices are contemplated.

Although the present invention has been described in terms of a preferred embodiment, various other modifications within the scope of the invention as defined in the claims will be apparent to those skilled in the art.

[Brief description of drawings]

FIG. 1 is an enlarged view of a syringe assembly (syringe assembly) according to the present invention.

FIG. 2 is a sectional view of a preferred syringe barrel.

3 is an enlarged view of the closed end of the syringe barrel of FIG.

FIG. 4 is a side view of the needle assembly.

FIG. 5 isometric of a preferred plunger assembly of the present invention.
view).

6 is a cross-sectional view of the plunger frame of the plunger assembly of FIG.

7 is an enlarged view of a sealing end portion (sealing end portion, sealing end portion) of the plunger frame of FIG.

8 is a cross-sectional view of the plunger assembly of FIG. 5 taken along line 8-8.

9 is an enlarged view of the retaining end of the plunger assembly of FIG.

FIG. 10 is a side view of a preferred mandrel of the present invention.

FIG. 11 is a side view of a preferred catch member of the present invention.

FIG. 12: Suitable syringe (syringe) in an assembled state and an unused state
FIG.

FIG. 13 is a view of FIG. 12 during initial substantial depression of the plunger assembly.
It is a figure which shows the syringe of FIG.

14 shows the syringe of FIG. 12 after filling the syringe.

FIG. 15 shows the front portion of the syringe of FIG. 12 when the syringe is inserted into a patient.

FIG. 16 shows the front portion of the syringe of FIG. 12 with the plunger assembly substantially depressed.

FIG. 17 shows the anterior portion of the syringe of FIG. 12 after the mandrel tip has entered the cavity of the needle assembly.

18 shows the front portion of the syringe of FIG. 12 when the plunger assembly is fully depressed.

FIG. 19 shows the syringe of FIG. 12 after retracting (after retracting) the needle assembly.

FIG. 20 is a diagram of a plunger assembly member formed by a first injection molding shot according to a preferred manufacturing method.

FIG. 21 is a diagram of a plunger assembly formed by a second injection overmolding shot according to a preferred manufacturing method.

─────────────────────────────────────────────────── ─── 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), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, SD, SL, SZ, TZ, UG, ZW ), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, C R, CU, CZ, DE, DK, DM, EE, ES, FI , GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, K Z, LC, LK, LR, LS, LT, LU, LV, MD , MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, S L, TJ, TM, TR, TT, UA, UG, US, UZ , VN, YU, ZA, ZW (72) Inventor Joseph Nevolon             United States 92130 Sa, California             Diego, Carmel Country Law             Number 31, 12608 (72) Inventor Robert Di Adams             08088 New Jersey, United States             Chamongs, Meetinghouse Court             No. 2 F-term (reference) 4C066 AA07 BB01 CC01 EE14 FF05                       HH12 LL25 LL26

Claims (24)

[Claims] 1. A hollow body comprising: a hollow body having one substantially open end and an opposite end formed with an opening through which the injection means passes; and a hollow body provided with the injection means passing through the opening. A retractable needle assembly located inside the hollow body and a plunger assembly located inside the hollow body, the plunger assembly comprising: a catch platform; and a sealing platform sealingly engaging the hollow body. An elongate frame portion extending therebetween, the elongate frame portion forming at least one guide track between the platforms; a retraction member releasably attached to the sealing platform, and movable within the guide track. A catch member having a configured guide and a catch tip, and a retracting part An elastomeric member extending between the catch member and the catch member, and a retaining assembly on the catch platform for receiving and securing the catch tip, thereby exerting tension on the elastomeric member. A single-use disposable syringe having a retaining assembly configured in, comprising: a mating means for mating the needle assembly and the retracting member; and an elastomer when the needle assembly and the retracting member are mated. A release means for releasing the tension acting on the member to draw the injection means into the hollow body. 2. The hollow body is a shoulder portion located in the vicinity of the open end portion, and when the catch member abuts, the catch member passes over the shoulder portion and passes into the hollow body. A syringe according to claim 1, comprising a shoulder adapted to prevent. 3. The plunger frame is freely movable with respect to the catch member so that the plunger frame is initially moved inside the hollow body, and is also freely movable with respect to the abutting catch plate. However, as a result, the engagement between the holding assembly and the catch tip portion is facilitated, and the catch plate is fixed to the plunger frame so as to move together with the plunger frame. 2. The syringe described in 2. 4. The syringe of claim 4, wherein an audible signal is produced when the retaining assembly and the catch tip are mated. 5. The syringe of claim 1, wherein the catch member is initially secured to the retaining assembly such that the elastomeric member is prestressed. 6. The sealing platform has a hollow integral shaft, and the retraction member is in and sealingly engaged with the first end of the integral shaft prior to the retraction. The syringe according to claim 1, wherein: 7. The syringe of claim 6, wherein the retraction member comprises retaining means for maintaining the retaining member fixed to the sealing platform prior to the retraction. 8. The syringe of claim 7, wherein the retaining means comprises an annular collar around the retracting member. 9. The syringe of claim 8, wherein the annular collar of the retaining means abuts an annular ring located within the hollow shaft. 10. The syringe of claim 6, further comprising a stop for sealingly engaging the second end of the hollow integral shaft. 11. The syringe according to claim 10, wherein the stop portion is formed integrally with the elastomer member. 12. The syringe of claim 1, wherein the sealing platform comprises an elastomeric sealing member that maintains sealing engagement with the hollow body. 13. The sealing member comprises first and second annular seals separated by a recessed region, each annular seal sealingly engaging the hollow body. Item 12. A syringe according to Item 12. 14. The hollow body engages with the first annular seal when the plunger assembly is substantially pressed to break the engagement of the first annular seal with the hollow body in a sealed state. 14. The syringe of claim 13 having at least one beveled end located near the closed end to allow trapped fluid to pass into the recessed area. 15. The syringe of claim 1, wherein the catch platform comprises an elastomeric thumb pad integral therewith. 16. The thumb pad enters the open end of the hollow body and sealingly engages the hollow body when the plunger assembly is substantially pressed. The syringe described. 17. The syringe of claim 16, wherein the hollow body includes an inner annular lip that engages the thumb pad and retains the thumb pad near the open end. 18. The closed end of the hollow body comprises a truncated cone in which the needle assembly is located and a convex surface located around the truncated cone. Syringe. 19. The syringe of claim 18, wherein pushing down on the plunger assembly produces a forward force that deflects the convex surface away from the truncated cone. 20. The flexure is generated at the same time as or immediately after the fitting between the holding member and the needle assembly.
9. The syringe according to item 9. 21. The tapered portion of the plunger assembly contacts and biases the hollow body near the closed end and biases it outwardly to assist in releasing the needle assembly from the hollow body. The syringe according to claim 1, wherein 22. The mating means for mating the needle assembly and the retraction member comprises a first geometrical structure integral with the needle assembly and a second geometrical structure integral with the retraction member. The syringe according to claim 1, having a biological structure. 23. At least two components of a first material that are rigid when cured, at least two rigid components that include a mounting region, and at least one component of a second material that is an elastomer when cured. A method of manufacturing an apparatus having: a) providing a first molding cavity forming a rigid component; b) filling the first molding cavity with the first material; and c) the first material. Substantially curing the material into a substantially rigid assembly, and d) forming the substantially rigid assembly into an elastomeric component such that at least two attachment components are positioned within the second molding cavity. Positioning step with respect to the second molding cavity E) filling the second molding cavity with the second material such that it covers at least a portion of each attachment portion, and f) at least substantially the second material. And g) at least one having an attachment portion that is at least partially covered by the second material to exert a tension on the elastomer component.
Removing at least one of the rigid components from the substantially rigid assembly having a mounting portion that is at least partially covered by the second material so that it can be moved relative to two other rigid components. A method comprising:,. 24. A plunger for use with a syringe including a retractable needle assembly, the plunger being configured to mate with a frame component, an elastomeric member, a first elastomeric mounting member and a needle assembly and a second mounting member. Providing a first molding cavity forming a frame component, a first elastomeric mounting member, and a retractable member having a second mounting member. B) filling the first molding cavity with a material that is substantially rigid when cured, and c) substantially curing the material from step b) above into a substantially rigid assembly. And d) the first and second mounting members are in the second molding cavity. Positioning the substantially rigid assembly to be positioned with respect to a second molding cavity forming an elastic member; and e) filling the second molding cavity with a material that becomes an elastomer when cured. At least partially covering each attachment member; f) at least substantially curing the second material; and g) first applying tension to the elastic member. Removing the retraction member from the substantially rigid assembly so that it can be moved relative to the mounting member.