Self retracting medical needle apparatus and methods

• US 5,616,135 A
• Filed: 12/01/1995
• Issued: 04/01/1997
• Est. Priority Date: 01/10/1995
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L., Thorne, Gale H., Owen, Charles V.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/565,881
• Time in Patent Office: 487 Days
• Field of Search: 604/192, 604/187, 604/198, 604/263, 604/195, 128/763-765, 128/919
• US Class Current: 604/192
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150488 Details of construction of shaft
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150603 by rotation, e.g. bayonet or screw
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 2005/3101 Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• CPC Class Codes: A61M 2005/3121 via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
• CPC Class Codes: A61M 2005/3206 Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe body
• CPC Class Codes: A61M 2005/3223 : Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2005/3224 : Means to disalign the needle tip and syringe nozzle
• CPC Class Codes: A61M 2005/3226 : with means obstructing or blocking the needle mounting opening
• CPC Class Codes: A61M 2005/3242 : Needle retraction by vacuum
• CPC Class Codes: A61M 2005/3247 : Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/586 : Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 25/0612 : Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/0631 : having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/283 : by telescoping of ampoules or carpules with the syringe body
• 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 5/322 : Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3232 : Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• 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

Abstract

Method and apparatus associated with safe retraction of medical needles after use. Embodiments are disclosed for self-retracting needle systems for both blood draw, syringe and catheter insertion systems. Invention manufacture requires only a minimal number and complexity of parts such that a projected manufacturing cost is potentially low enough to permit the apparatus to be cost competitive with contemporary non-self retracting needle systems. Methods for making and assembling each of the disclosed the embodiments is also disclosed. One blood draw embodiment can be made with as few as three molded parts. Energy-storing, needle-retracting mechanisms comprise elastic tubing and vacuum generating piston parts. In an elastic tubing embodiment, selective, constrictive control of stretched tubing volumes effectively inhibits regurgitant flow from the needle. In all embodiments, needle retraction is a single handed operation permitting a technicians other hand to be used in wound care. Use of frangible parts permits the apparatus housing to be attached to a needle cover, which, in combination, are used as a transport container to further reduce apparatus costs.

Claims

1. Apparatus for transporting and using and then safely retracting a medical needle directly from a patient into a container after use, said apparatus comprising:

the container comprising;

one end through which the medical needle passes when retracted;

another end which is moved apart from the medical needle to permit extension of said apparatus whereby the apparatus and the medical needle are configured for use in a medical procedure;

at least one container based catch for an associated latch whereby said apparatus is securely affixed in the extended configuration;

a portion of the container which is deformable such that a predetermined deformation of the container portion, in combination with a needle support catch, a releasable latch and trigger means, causes the needle to be released for safe retraction into the container;

a needle cover releasibly coupled to the container at the one end, the needle cover in combination with the container providing a protective barrier for contents of the cover and container prior to extending the apparatus;

a medical needle assembly disposed for transport and storage within said cover and container, said assembly comprising;

the medical needle comprising a sharpened point for entry into a patient and a pathway for flow of medical and physiological fluids;

connector hub means comprising;

a secure attachment to the medical needle;

the releasable latch which is integrally joined to the attachment and which is affixed to the needle support catch when the apparatus is extended to secure the medical needle for use in the medical procedure;

the trigger means for releasing the medical needle from being affixed by the needle support catch and releasable latch when acted upon via deformation of the container portion; and

a connecting hub which is integral with said attachment and which affixes said assembly to a linear motion energy storage member;

the needle support catch which is disposed in a predetermined position to thereat be engaged with the releasable latch when the apparatus is extended;

the linear motion energy storage member comprising a first end which is proximal to the connecting hub and a second end which is distal from the connecting hub, said member being attached to the connecting hub at the first end for storing medical needle retraction energy as the other end of the container and needle are moved apart as the apparatus is extended.

2. Apparatus according to claim 1 wherein said linear motion energy storage member comprises elastic tube means which comprise an elongated elastic tube which is stretched as the apparatus is extended to provide both energy for retracting said needle and a fluid pathway from said needle.

3. Apparatus according to claim 2 wherein said elastic tube is made from silicone rubber.

4. Apparatus according to claim 2 wherein said elastic tube is made from medical grade latex.

5. Apparatus according to claim 2 wherein said connecting hub comprises a barbed fitting for the elastic tube.

6. Apparatus according to claim 2 wherein said connecting hub comprises a fitting for said elastic tube which is substantially the same outside diameter as the inside diameter of the elastic tube to limit increase in internal volume of the elastic tube as the tube is stretched.

7. Apparatus according to claim 2 wherein, in combination, said container and connector hub means comprise means for causing the internal volume of the stretched elastic tube to be smaller than the internal volume of the elastic tube during and after retraction of the needle to eliminate regurgitant flow from the needle as a result of retraction.

8. Apparatus according to claim 2 wherein the elastic tube means further comprise volume restricting means in restrictive communication with the elastic tube which, as the tube is stretched, compressibly reduce the internal volume of the elastic tube to a volume which is less than the elastic tube when unstretched to eliminate liquid regurgitation when the needle is retracted.

9. Apparatus according to claim 8 wherein the volume restricting means is made from the same material as the elastic tube.

10. Apparatus according to claim 2 further comprising a barrel part integrally affixed at the other end of the container and an elastic tube connection, said barrel part receiving biological fluid through the connection to the elastic tube and being instrumental in delivering biological fluid from a patient to an evacuated blood collection tube, an example of which is a Vacutainer®

by Becton Dickenson.

11. Apparatus according to claim 2 further comprising a luer fitting integrally affixed at the other end of the container and a connection between the fitting and the elastic tube, said fitting receiving fluid through the connection to the elastic tube.

12. Apparatus according to claim 1 wherein said needle is a catheter insertion needle.

13. Apparatus according to claim 12 further comprising a catheter initially disposed about said catheter insertion needle and slidably removable therefrom as the catheter insertion needle is retracted.

14. Apparatus according to claim 12 wherein said linear motion energy storage member comprises elastic tube means which comprise an elastic tube which provides both energy for retracting said needle and a fluid pathway from said needle.

15. Apparatus according to claim 12 wherein said elastic tube is made from silicone rubber.

16. Apparatus according to claim 12 wherein said elastic tube is made from medical grade latex.

17. Apparatus according to claim 12 further comprising a filter which discriminately passes gasses but is impervious to liquids and a user viewable blood flash part which provides a visual indication of blood received through the needle.

18. Apparatus according to claim 1 wherein the container-based catch and needle support catch are the same part and the associated latch and releasable latch are the same part.

19. Apparatus according to claim 1 wherein said needle support catch comprises a slidable connection to said needle wherethrough the needle passes during retraction.

20. Apparatus according to claim 19 wherein said connection comprises a plug which substantially voids access to the container following retraction of the needle.

21. Apparatus according to claim 19 wherein said needle support catch and releasable latch are a single part joined by a frangible bridge which is broken through action of the trigger means.

22. Apparatus according to claim 1 wherein said catch comprises a slidable connection to said needle and a plug which closes all of the one end except for the slidable connection which comprises a small longitudinal hole substantially the diameter of the needle.

23. Apparatus according to claim 22 wherein said catch is made from hydrophobic material to substantially eliminate blood flow through the slidable connection hole.

24. Apparatus according to claim 1 wherein said needle support catch comprises a needle cover connector and said needle cover comprises a complementary catch connector whereby the needle cover is releasibly connected to cover and protect the needle assembly.

25. Apparatus according to claim 1 wherein said needle cover and said container, in combination, comprise a frangible part which connects the needle cover to the container for transport and storage prior to use and which is frangibly broken to permit apparatus extension, said needle cover and said container providing a sterile protective barrier for the medical needle assembly while joined and said frangible part providing a indicator for detection of tampering.

26. Apparatus according to claim 1 wherein said container comprises an exterior shield which, until removed, protects the deformable portion from inadvertent triggering during the medical procedure and which is facilely removed for access to the deformable portion and therethrough to the trigger means.

27. A method for using an apparatus which safely retracts a medical needle directly from a patient into a container after completing a medical procedure comprising the steps of:

providing an extendable apparatus comprising a container into which the medical needle is retracted, the medical needle initially disposed for protection within apparatus and attached to a linear motion energy storage member which receives needle retraction energy when the apparatus is extended and a removable needle cover and which is activated by a trigger, the container comprising a deformable portion which communicates with a trigger which accessible through the deformable portion;

extending the apparatus, thereby positioning the needle for use in the medical procedure, cocking the trigger and storing energy in the linear energy storage member;

exposing the needle by removing the needle cover;

introducing the medical needle into the patient;

performing the medical procedure;

accessing the deformable portion by placing a portion of a users hand thereover;

depressing the deformable portion thereby triggering release of the linear energy storage member and thereby safely retracting the medical needle into the container.

28. A method according to claim 27 wherein the accessing step comprises removing a shield which covers and protects the deformable portion from inadvertent triggering.

29. A method according to claim 27 wherein the retracting step comprises retracting the needle through a hole in the container approximately the same size as the outside diameter of the needle, thereby substantially retracting the needle into a closed container relative to opportunity for the needle or liquid to escape the container after retraction.

30. A method according to claim 27 wherein the safely retracting step comprises elastically compacting a elastic tube previously stretched in the extending step, the stretched tube providing both storage of retractive energy and a pathway for biological fluid flow.

31. A method according to claim 30 wherein the extending and retracting steps, in combination, limit the internal volume of the elastic tube when stretched to be less than the elastic tube when compacted.

32. A method according to claim 27 wherein the performing step comprises utilizing means for drawing blood using an evacuated blood collection tube.

33. A method according to claim 27 wherein the performing step comprises utilizing means for introducing an IV (intravenous) catheter into the patient.

34. A method according to claim 27 wherein the introducing and performing steps, in combination, comprise employing a luer fitting to attach the apparatus to a syringe.

35. A method according to claim 27 wherein the accessing step comprises using pressure from a single finger to cause the needle to be retracted from the patient.

36. Apparatus for transporting and using and then safely retracting a medical needle directly from a patient into a container after use, said apparatus comprising:

the container comprising;

one end through which the medical needle passes when retracted;

another end which is moved apart from the medical needle to permit extension of said apparatus whereby the apparatus and the medical needle are configured for use in a medical procedure;

at least one container based catch for an associated latch whereby said apparatus is securely affixed in the extended configuration;

a portion of the container comprising force communicating means through which a trigger is activated in combination with a releasable latch, to cause the needle to be released for safe retraction into the container;

a needle cover releasibly coupled to the container at the one end, the needle cover in combination with the container providing a protective barrier for contents of the cover and container prior to extending the apparatus;

a medical needle assembly disposed for transport and storage within said cover and container, said assembly comprising;

the medical needle comprising a sharpened point for entry into a patient and a pathway for flow of medical and physiological fluids;

connector hub means comprising;

a secure attachment to the medical needle;

the releasable latch which is integrally joined to the attachment and which is affixed to the needle support catch when the apparatus is extended to secure the medical needle for use in the medical procedure;

the trigger means for releasing the medical needle from being affixed by the needle support catch and releasable latch when acted upon via force through the communicating means of the container portion; and

a connecting hub which is integral with said attachment and which affixes said assembly to a linear motion energy storage member;

the needle support catch which is disposed in a predetermined position to thereat be engaged with the releasable latch when the apparatus is extended;

the linear motion energy storage member comprising an elastic tube having a first end which is proximal to the connecting hub and a second end which is distal from the connecting hub, said member being attached to the connecting hub at the first end for storing medical needle retraction energy in the elastic tube as the other end of the container and needle are moved apart as the apparatus is extended, said tube also providing a lumen which acts as a pathway for medical and physiological fluids which pass through said needle.

37. Apparatus according to claim 36 wherein said energy communicating means comprise a deformable portion of said container.

38. Apparatus according to claim 36 wherein said elastic tube is made from silicone rubber.

39. Apparatus according to claim 36 wherein said elastic tube is made from medical grade latex.

40. Apparatus according to claim 36 wherein said connecting hub comprises a barbed fitting for the elastic tube.

41. Apparatus according to claim 36 wherein said connecting hub comprises a fitting for said elastic tube which is substantially the same outside diameter as the inside diameter of the elastic tube to limit increase in internal volume of the elastic tube as the tube is stretched.

42. Apparatus according to claim 36 wherein, in combination, said container and connector hub means comprise means for causing the internal volume of the stretched elastic tube to be smaller than the internal volume of the elastic tube during and after retraction of the needle to eliminate regurgitant flow from the needle as a result of retraction.

43. Apparatus according to claim 36 wherein the elastic tube means further comprise volume restricting means in restrictive communication with the elastic tube which, as the tube is stretched, compressibly reduce the internal volume of the elastic tube to a volume which is less than the elastic tube when unstretched to eliminate liquid regurgitation when the needle is retracted.

44. Apparatus according to claim 43 wherein the volume restricting means is made from the same material as the elastic tube.

45. Apparatus according to claim 36 further comprising a barrel part integrally affixed at the other end of the container and an elastic tube connection, said barrel part receiving biological fluid through the connection to the elastic tube and being instrumental in delivering biological fluid from a patient to an evacuated blood collection tube, an example of which is a Vacutainer®

by Becton Dickenson.

46. Apparatus according to claim 36 further comprising a luer fitting integrally affixed at the other end of the container and a connection between the fitting and the elastic tube, said fitting receiving fluid through the connection to the elastic tube.

47. Apparatus according to claim 36 wherein said needle is a catheter insertion needle.

48. Apparatus according to claim 47 further comprising a catheter initially disposed about said catheter insertion needle and slidably removable therefrom as the catheter insertion needle is retracted.

49. Apparatus according to claim 47 further comprising a filter which discriminately passes gasses but is impervious to liquids and a user viewable blood flash part which provides a visual indication of blood received through the needle.

50. Apparatus according to claim 36 wherein the container-based catch and needle support catch are the same part and the associated latch and releasable latch are the same part.

51. Apparatus according to claim 36 wherein said needle support catch comprises a slidable connection to said needle wherethrough the needle passes during retraction.

52. Apparatus according to claim 51 wherein said connection comprises a plug which substantially voids access to the container following retraction of the needle.

53. Apparatus according to claim 51 wherein said needle support catch and releasable latch are a single part joined by a frangible bridge which is broken through action of the trigger means.

54. Apparatus according to claim 36 wherein said needle support catch comprises a slidable connection to said needle and a plug which closes all of the one end except for the slidable connection which comprises a small longitudinal hole substantially the diameter of the needle.

55. Apparatus according to claim 54 wherein said needle support catch is made from hydrophobic material to substantially eliminate blood flow through the slidable connection hole.

56. Apparatus according to claim 36 wherein said needle support catch comprises a needle cover connector and said needle cover comprises a complementary catch connector whereby the needle cover is releasibly connected to cover and protect the needle assembly.

57. Apparatus according to claim 36 wherein said needle cover and said container, in combination, comprise a frangible part which connects the needle cover to the container for transport and storage prior to use and which is frangibly broken to permit apparatus extension, said needle cover and said container providing a sterile protective barrier for the medical needle assembly while joined and said frangible part providing a indicator for detection of tampering.

58. Apparatus according to claim 36 wherein said container comprises an exterior shield which, until removed, protects the force communicating means and therefore the trigger from inadvertent triggering during the medical procedure and which is facilely removed for access to the deformable portion and therethrough to the trigger means.

59. Apparatus for transporting and using and then safely retracting a medical needle directly from a patient into a container after use, said apparatus comprising:

the container into which the needle is retracted;

the medical needle through which medical and physiological fluids flow;

an elastic tube is which is directly joined to said medical needle, stretched to store energy required for retraction of the medical needle and which comprises a lumen which serves as a pathway for the medical and physiological fluids;

at least one member which compresses the elastic tube when stretched to assure a smaller internal volume of the elastic tube lumen when the elastic tube is stretched and a larger internal volume of the elastic tube lumen when the elastic tube is unstretched.

60. Apparatus as in claim 59 wherein said at least one member is made from the same material as the elastic tube.

61. Apparatus as in claim 59 wherein said at least one member is integrally joined to said elastic tube.

62. A method for retracting a medical needle into a container for safe containment without regurgitating fluid outwardly from said needle comprising the steps of:

providing the container into which the needle is retracted;

providing the medical needle which is disposed outside the container for use in a medical procedure and which is retracted into said container at the end of the procedure;

providing an elastic tube which is securely affixed to the needle, stretched to provide retraction energy for the needle and which inherently comprises a lumen which provides a pathway for fluids passing through said needle, said lumen comprising a rest volume when the elastic tube is in an unstretched state;

compressing the exterior of the elastic tube when stretched to reduce the volume of the lumen without closure of the lumen to a volume which is less than the rest volume; and

retracting the needle as the elastic tube is elastically relaxed substantially to the unstretched state without compressing the exterior of the elastic tube thereby permitting the lumen of the elastic tube when relaxed to be greater than the lumen of the elastic tube when stretched, said larger volume of the relaxed tube being the result of forces inherent in the tube which assure retention of fluid within the lumen as the tube is shortened.