Single use medical device with retraction mechanism

• US 5,389,076 A
• Filed: 04/05/1994
• Issued: 02/14/1995
• Est. Priority Date: 04/05/1994
• Status: Expired due to Term

• Current Assignee: Thomas J Shaw
• Original Assignee: Thomas J Shaw
• Inventors: Shaw, Thomas J.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/222,888
• Time in Patent Office: 315 Days
• Field of Search: 604/110, 604/187, 604/192, 604/195, 604/198, 604/218, 604/263
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/3241 Needle retraction energy is accumulated inside of a hollow plunger rod
• CPC Class Codes: A61M 2005/3242 Needle retraction by vacuum
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/508 Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

Abstract

A single use retractable syringe has three main parts which are coaxially arranged. An outer barrel is fitted with a slidable plunger and an elongated needle rod is carried within the plunger and biased for retraction. In the unretracted position of the needle rod, an injection needle is extended from the front of the barrel. The needle rod is held in the unretracted position by a resilient ring member frictionally mounted on one larger part of the needle rod just behind a reduced size front part of the needle rod. The needle communicates with a variable fluid chamber behind the resilient ring member below the front end of the plunger. After an injection, further depression of the plunger pushes the resilient ring member forward and off the larger diameter portion of the needle rod to release the needle rod which is biased to retract along with the needle into the plunger. The needle rod may be biased in the retraction direction by a spring or by a vacuum in the plunger behind the needle rod. The device is simple in operation and especially suited for mass production and robotic assembly. Retraction is reliable and permanent.

Claims

1. In a single use medical device having a retraction mechanism with a needle for collecting and injecting fluid, an elongate hollow outer body containing a retraction mechanism and a plunger slidable axially in the outer body, the retraction mechanism including a needle holding member having an unretracted extended position wherein the needle is extended from the body while being biased toward a retracted position entirely within the body, a biasing element for applying retraction force to the needle holding member in a retraction direction and a release element capable of holding the needle holding member against the biasing force provided by the biasing element, the release element being triggered to release the needle holding member for retraction of the needle in response to selective movement of the plunger, the improvement comprising:

the needle holding member comprises an elongated needle rod having a needle extending from a front end thereof, said needle rod having a front portion and a back portion wherein said front portion is a smaller than said back portion;

said release element is a separate release element slidingly mounted on the back portion of said needle rod, behind the smaller front portion and held thereon with a friction force that exceeds said retraction force;

said release element cooperates with the outer body to hold the needle rod with the needle extended in the unretracted position while the plunger is movable relative to said outer body to collect or inject fluid;

part of the back portion of said needle rod being positioned within said plunger at all positions of the plunger while moving the plunger during use of the device for collecting and injecting fluid;

retraction is initiated by relative movement of the release element from the back portion to the smaller front portion of the needle rod, caused by force applied by the front of the plunger to the release element at the end of the plunger stroke; and

retraction occurs when the release element loses its frictional holding force in excess of said retraction force as a result of the release element being pushed to the smaller front portion of the needle rod whereupon the needle rod is free to retract and moves into said retracted position.

2. The single use medical device of claim 1 wherein a varying chamber for injection fluid is created behind the release element by rearward movement of the plunger away from the release element, said chamber being in fluid communication with an opening in the needle.

3. The single use medical device of claim 2 wherein said biasing element operates inside the plunger to apply said retraction force in the retraction direction to the needle rod.

4. The single use medical device of claim 2 wherein the varying chamber for injection fluid is sealed by the retainer member and by a front head portion of the plunger having a resilient piston which slides with the plunger inside the outer body.

5. The single use medical device of claim 1 wherein during use of the device, with the needle in the extended unretracted position, the back portion of the needle rod passes through the front head portion of the plunger and is sealed thereby.

6. The single use medical device of claim 5 wherein said biasing element is mounted inside the plunger and operates to apply said retraction force in the retraction direction to said needle rod.

7. The single use medical device of claim 6 wherein the interior of the plunger has a support surface for one end of said biasing element and the back end of the needle rod has a sliding guide head and a support surface for the other end of the biasing element, the biasing dement comprising a spring compressible between said support surfaces to provide said retraction force to the needle rod.

8. The single use medical device of claim 7 wherein the plunger has a laterally enlarged back with an axially aligned opening for insertion of the needle rod, the opening having a restricted diameter through which the guide head of the needle rod can be forced in one direction during assembly but prevents the needle rod from exiting thereafter.

9. The single use medical device of claim 1 wherein the outer body has a front end portion from which the needle, in the unretracted position of the needle rod, extends for use;

the front end portion of the outer body being equipped with a tip member having a stop surface located in the path of the needle rod to arrest forward movement of the needle rod.

10. The single use medical device of claim 9 wherein in the unretracted position of the needle, the needle rod has a front end positioned against the stop surface of the tip member to prevent forward movement, and said release element cooperates with a stop surface on the inside of the outer body to prevent reverse movement of the needle rod.

11. The single use medical device of claim 10 wherein the needle member has a portion enclosed within the front of the needle rod, terminating at a fluid opening in the needle rod which is located behind the release element with the needle extended in the unretracted position.

12. The single use medical device of claim 11 wherein the release element is a resilient ring member which simultaneously creates a sliding seal around the needle rod and around the interior of the outer body when said resilient ring member is positioned on the back portion of the needle rod with the needle rod and needle in the unretracted position, thereby establishing the bottom of said variable chamber within the outer body above said resilient ring member.

13. The single use medical device of claim 12 wherein the plunger has a front head portion through which the back portion of the needle rod is sealingly extended into the plunger when the needle is in the extended position for use.

14. The single use medical device of claim 13 wherein a resilient piston on the front head portion of the piston simultaneously slidingly seals the back portion of the needle rod and the inner surface of the outer body, with the needle in the extended position.

15. The single use medical device of claim 13 wherein the resilient piston has a laterally extending face and an opening through which the back portion of the needle rod sealingly passes with the needle rod extended, said face and said resilient ring member coming together to expel substantially all fluid from said variable chamber when the plunger is depressed and thereafter upon further depression, the face of said piston serving to move the ring member from its previous position into a position over said smaller front portion of the needle member, thereby initiating said retraction.

16. A single use syringe having a permanently retractable needle for injecting fluid into a body comprising:

(a) a hollow outer body having a longitudinal axis and being elongated axially between a tip end at the front and a back end and providing a cavity for the fluid;

(b) a movable plunger disposed partially within the hollow outer body, having an internal space and a front portion having a piston mounted thereon in slidable sealed contact with the interior surface of the hollow outer body to form a variable chamber for the fluid below the piston;

(c) a needle rod axially positioned partially within the internal space of the plunger, the needle rod having a front portion extending through the piston, said front portion having an embedded needle and a front end from which said needle protrudes;

(d) a retainer member mounted on the front portion of the needle rod below the piston in contact with the interior surface of the hollow outer body, the retainer member frictionally but slidably engaging the needle rod with a frictional holding force to hold the needle rod in an unretracted position with the needle extended for use;

(e) a biasing means within the plunger applying a retraction force to the needle rod which is less than said frictional holding force;

(f) a stop member in the tip end of said outer body in the path of the front end of the needle rod and a stop above the retainer member to prevent the needle rod from moving axially;

(g) a reduced size portion of the needle rod below said retainer member and above the front end of the needle rod;

(h) whereby, the plunger may be used to draw fluid into a variable chamber above the retainer member and to expel said fluid by depression of the plunger and upon further depression of the plunger after said fluid has been expelled, the retainer member is moved forward to the reduced size portion of the needle rod whereupon the frictional holding force becomes less than the retraction force which automatically causes the needle rod and needle to permanently retract into the syringe.

17. The single use syringe of claim 16 wherein the hollow outer body is a cylindrical barrel and said retainer member has a circular outer surface adapted to slidingly and sealingly contact the interior surface of the cylindrical outer body.

18. The single use syringe of claim 17 wherein said retainer member has a circular outer surface which is smaller in diameter than the interior of the cylindrical body and a circular land which is adapted to slidingly seal the interior surface of said cylindrical outer body.

19. The single use syringe of claim 17 wherein said retainer member is made from a resilient elastomer having a durometer of at least about 40.

20. The single use syringe of claim 16 wherein the front portion of the plunger is in slidingly sealed contact with the needle rod while the needle rod and needle are in the unretracted position with the needle extended for use.

21. The single use syringe of claim 20 wherein the piston on the front portion of the plunger is a resilient piston which simultaneously seals the needle rod and the inner surface of the outer body, with the needle in the extended position.

22. The single use syringe of claim 21 wherein the resilient piston has a laterally extending face and an opening through which the back portion of the needle rod sealingly passes with the needle rod extended, said face and said retainer member coming together to expel substantially all fluid from said variable chamber when the plunger is depressed and thereafter upon further depression, the face of said piston serving to move the retainer member from its previous position to a position over said reduced size portion of the needle rod, thereby initiating retraction.

23. The single use syringe of claim 16 wherein the back end of the needle rod has a glide head which slides loosely in the plunger and provides lateral support for the needle rod in aid of smooth retraction.

24. The single use syringe of claim 17 wherein said retraction force is applied to said guide head by said biasing means.

25. The single use syringe of claim 24 wherein said biasing means comprises an elongated spring surrounding said needle rod.

26. The single use syringe of claim 24 wherein said glide head is a sealing head which slidingly seals the back portion of said plunger, said plunger behind said sealing head being provided with a vacuum chamber which serves to apply said retraction force to said needle rod through said sealing head.

27. A single use syringe having a permanently retractable needle for injecting fluid into a body comprising:

a syringe body having a back and a front tip portion, the syringe body having an inner surface and an elongated plunger having a piston slidingly mounted for selective movement within the interior of the syringe body;

an elongated needle rod coaxially mounted within said plunger for positioning in an unretracted position and a retracted position, said needle rod being biased with a retraction force in a retraction direction toward the back of said syringe;

said needle rod having a front end from which a needle extends;

a resilient retainer member mounted on the needle rod and spaced behind said front end, said retainer member slidingly and frictionally engaging said elongated needle rod and holding said needle rod with a friction force exceeding said retraction force;

a variable chamber being defined within said syringe body between said retainer member and said piston and being in fluid communication with said needle;

stop member in said syringe body to restrain the resilient release member from movement in the retraction direction and establish the needle rod in the unretracted position with the needle extended;

means for preventing forward movement of the needle rod when the plunger is depressed;

whereby the needle rod is released for retraction in the retraction direction by depression of the plunger causing forward movement of the retainer member on the needle rod, said forward movement of the retainer member being accompanied by reduction of said frictional holding force and release of the needle rod whereupon the retraction force drives the needle rod and needle to the retracted position in the retraction direction entirely within the syringe.

28. The single use syringe of claim 27 wherein said needle rod includes a glide head comprising a sealing head which slidingly seals the back portion of said plunger, said plunger behind said sealing head being provided with a vacuum chamber which serves to apply said retraction force to said needle rod through said sealing head.

29. A single use syringe having a permanently retractable needle for injecting fluid into a body comprising:

a hollow syringe body having a tip portion containing means for preventing a needle rod from moving forward;

a hollow plunger having a front end portion equipped with a piston slidingly sealing the interior of the syringe body and defining the upper boundary of a variable fluid chamber within said syringe body;

a needle rod having a front end equipped with a needle and being slidingly mounted in the plunger, said needle rod having an unretracted position with the needle extended from the tip portion of the syringe for use and a retracted position wherein said needle rod and needle are withdrawn within the syringe;

a resilient release element frictionally mounted on the needle rod below the piston and cooperating with a stop in the syringe body to keep the release element from moving backward away from the tip portion of the syringe body, the release element being positioned on the needle rod at an axial location which positions the needle rod against the means for preventing the needle rod from moving forward;

the resilient release element defining a lower boundary of said variable fluid chamber within said syringe body and being movable to a release position in response to depression of said plunger wherein said resilient release element is released from frictional engagement with said needle rod to initiate retraction of the needle rod and needle to said retracted position;

a biasing means associated with said plunger to apply a retraction force to said needle rod so that when said resilient release element is released from said needle rod in response to depression of the plunger, said needle rod and said needle are automatically retracted into said syringe.