Safety syringe

• US 6,156,013 A
• Filed: 11/04/1998
• Issued: 12/05/2000
• Est. Priority Date: 11/04/1998
• Status: Expired due to Term

• Current Assignee: Sudha S. Mahurkar Trust
• Original Assignee: Sakharam D. Mahurkar
• Inventors: Mahurkar, Sakharam D.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US09/187,316
• Time in Patent Office: 762 Days
• Field of Search: 604/195, 604/198, 604/218, 604/187, 604/110
• US Class Current: 604/195
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612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

Abstract

A single-use safety syringe assembly comprises an elongated, generally cylindrical barrel which forms a hollow nozzle located at the distal end of the barrel and which opens into the interior of the barrel. A plunger is slidably mounted in the barrel and forms a longitudinal cavity. A needle holder carries a hollow needle on its distal end, and the needle holder is slidably mounted in the longitudinal cavity of the plunger. A biasing arrangement urges the needle holder in a direction for retracting the needle into the barrel. However, a releasable latching arrangement retains the needle holder against the urging of the biasing arrangement in a position wherein the needle projects from the barrel. An In-Barrel assembly sequence is provided which permits sequentially inserting components of the syringe into the barrel and effecting assembly with a push of the plunger. An OTN catheter may also be employed in combination with the syringe assembly.

Claims

1. A safety syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel,

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle;

a needle holder mounting said needle at a distal end thereof and slidably mounted in said longitudinal open channel of said plunger for movement between an advanced position in which said needle on the distal end of said needle holder projects from a distal end of said nozzle, and a retracted position in which said needle is retracted within said barrel;

a compression spring mounted inside of said barrel and means supporting a distal end portion of said spring against expansion;

said spring urging said needle holder toward its retracted position; and

a latch arrangement having a closed position in which said needle holder is latched relative to said barrel to hold said needle holder in its advanced position against the urging of said spring, and an open position in which said needle holder is unlatched relative to said barrel to allow said spring to expand in a proximal direction to move said needle holder to its retracted position;

said latch arrangement including a radially projecting arm on one of said needle holder and said barrel by which the needle holder is directly or indirectly engaged with the barrel, at least when in its closed position.

2. The syringe assembly of claim 1 wherein said spring is a helical spring disposed around said plunger.

3. The syringe assembly of claim 1 wherein said spring is a helical spring disposed around said needle holder within said longitudinal open channel of said plunger.

4. The syringe assembly of claim 1 wherein said spring is a helical spring.

6. The syringe assembly of claim 1 wherein said barrel includes a guide slot and wherein said needle holder includes a lateral arm extending laterally from said plunger open channel into said guide, whereby said needle holder is guided by said guide slot as it moves toward its retracted position.

7. The syringe assembly of claim 6 wherein said latch is mounted for movement into and out of registry with a distal end of said guide slot for capturing and releasing said lateral arm at the distal end of said guide slot.

8. The syringe assembly of claim 1 which includes a hollow needle attached to the distal end of said needle holder.

11. The syringe assembly of claim 1 wherein said barrel has outwardly extending gripping flanges and said latch comprises a needle holder locking element mounted on one of said barrel flanges for movement between a locking position and non-locking position.

12. The syringe assembly of claim 6 wherein said guide slot is formed in the wall of said barrel and extends radially through the wall of said barrel.

13. The syringe assembly of claim 6 wherein said guide slot includes a detent at a proximal end thereof for resisting advancing movement of said needle holder after it has been fully retracted.

14. The syringe assembly of claim 1 wherein said longitudinal open channel of said plunger includes a detent for slidably retaining said needle holder within said longitudinal channel.

15. The syringe assembly of claim 1 wherein said barrel includes an outwardly extending finger flange to facilitate gripping of the barrel, and wherein said flange can be used to rotate the barrel relative to the plunger in a direction for releasing said latch to effect one-handed rotary retraction of the needle holder.

16. The syringe assembly of claim 15 wherein said lateral arm extends radially through the barrel wall, and wherein said latch is located adjacent said flange to engage a portion of said lateral arm.

17. The syringe assembly of claim 1 wherein said latch is formed on said needle holder and releasably engages said barrel.

18. The syringe assembly of claim 1 and further including a retaining member comprising said means for supporting a distal end portion of the spring.

19. The syringe assembly of claim 18 and further including an inwardly extending surface on said barrel supporting said retaining member.

20. The syringe assembly of claim 6 wherein said latch is located at a distal end of said guide slot, and comprises a longitudinal track on an outer surface of said barrel and a locking element slidably mounted on said track for reciprocating movement between a locking position at said distal end of said guide slot and a non-locking position away from said distal end of said guide slot.

21. The syringe assembly of claim 1 wherein said latch comprises a locking element formed as an integral part of the outer surface of said barrel and including an integral hinge permitting pivoting movement of said locking element between a locking position and a non-locking position.

32. The syringe assembly of claim 21 wherein said longitudinal open channel of said plunger includes a detent for slidably retaining said needle holder within said longitudinal open channel.

63. The syringe assembly of claim 1, wherein said channel of said plunger has a locking detent that holds the needle holder at the proximal end of the plunger when retracted.

5. A safety syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger for movement between an advanced position in which a needle on the distal end of said needle holder projects from a distal end of said nozzle, and a retracted position in which said needle is retracted within said barrel;

a spring mounted inside said barrel and urging said needle holder toward its retracted position; and

a latch having a closed position in which said needle holder is latched to said barrel to hold said needle holder in its advanced position against the urging of said spring, and an open position in which said needle holder is unlatched from said barrel to allow said spring to move said needle holder to its retracted position;

wherein said needle holder has a lateral arm which extends radially, and wherein said latch engages said lateral arm of said needle holder when said latch is in its closed position.

9. The syringe assembly of claim 5 wherein said spring comprises a helical spring disposed around said plunger.

10. A safety syringe assembly comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger for movement between an advanced position in which a needle on the distal end of said needle holder projects from a distal end of said nozzle, and a retracted position in which said needle is retracted within said barrel;

a spring mounted inside said barrel and urging said needle holder toward its retracted position; and

a latch having a closed position in which said needle holder is latched to said barrel to hold said needle holder in its advanced position against the urging of said spring, and an open position in which said needle holder is unlatched from said barrel to allow said spring to move said needle holder to its retracted position;

wherein said latch comprises a needle holder locking element rotatably mounted on said barrel for rotary movement between a locking position and non-locking position on the barrel.

22. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger;

a latch arrangement for latching and unlatching said needle holder relative to said barrel;

said latch arrangement including a radially projecting arm on one of said needle holder and said barrel by which the needle holder is directly or indirectly engaged with the barrel, at least when latching said needle holder relative to said barrel; and

a compression spring located in said barrel in surrounding relation to said needle holder and having a distal end held against expansion so as to expand in a proximal direction for retracting said needle holder in response to unlatching said needle holder by said latching means.

23. The syringe assembly of claim 22 wherein said spring comprises a coil spring disposed around said plunger.

24. The syringe assembly of claim 22 wherein said spring comprises a coil spring disposed around said needle holder within said longitudinal open channel of said plunger.

25. The syringe assembly of claim 22 wherein said spring comprises a coil spring, and further including a support member for supporting a distal end of said coil spring.

26. The syringe assembly of claim 25 wherein the support member comprises an L-shaped bracket supported by a proximal portion of said barrel.

29. The syringe assembly of claim 22 wherein said barrel includes outwardly extending gripping flanges and said latch comprises a locking element mounted on one of said barrel flanges for movement between a locking position and non-locking position relative to said needle holder.

37. The syringe assembly of claim 22 and further including a support element to support the spring at a distal end portion of the spring.

38. The syringe assembly of claim 23 and further an inwardly extending surface on said barrel which supports a distal end of the spring.

40. The syringe assembly of claim 22 wherein said latch comprises a locking element formed as an integral part of the outer surface of said barrel and including an integral hinge for permitting pivoting movement of said locking element between a locking position and a non-locking position.

41. The syringe assembly of claim 22 wherein the barrel and plunger have cooperating interlocking elements which engage and lock when the plunger is fully advanced relative to the barrel, to prevent retraction of the plunger.

64. The syringe assembly of claim 22, wherein said channel of said plunger has a locking detent that holds the needle holder at the proximal end of the plunger when retracted.

27. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger;

a latch for latching and unlatching said needle holder relative to said barrel; and

a spring for retracting said needle holder in response to unlatching said needle holder by said latching means;

wherein said needle holder has a lateral arm which extends radially, and wherein said latch releasably engages the lateral arm of said needle holder.

28. The syringe assembly of claim 27 wherein said latch comprises a needle holder locking element rotatably mounted on said barrel for rotary movement between a locking position and non-locking position relative to said lateral arm.

30. The syringe assembly of claim 27 wherein a guide slot is formed in a proximal wall portion of said barrel for receiving and guiding said lateral arm.

31. The syringe assembly of claim 30 wherein said guide slot includes a detent at a proximal end thereof for resisting advancing movement of said needle holder after it has been fully retracted.

33. The syringe assembly of claim 30 wherein said barrel includes outwardly extending finger flanges to facilitate gripping of the barrel, and wherein said flanges can be used to rotate the barrel relative to the plunger in a direction for releasing said latch to effect one-handed rotary retraction of the needle holder.

34. The syringe assembly of claim 33 wherein said lateral arm extends radially through the barrel wall.

35. The syringe assembly of claim 34 wherein said latch is located adjacent said flange to releasably engage a portion of said needle holder lateral arm.

36. The syringe assembly of claim 30 wherein said needle holder includes a lateral arm for engaging the latch and said barrel has an open end and said plunger includes recesses alignable with said open end of said barrel for defining a relief space for deformation of said open end of barrel to permit initial insertion of said lateral arm of said needle holder past said open end of said barrel and into said guide slot.

39. The syringe assembly of claim 30 wherein said latch comprises a longitudinal track on an outer surface of said barrel and a locking element slidably mounted on said track for reciprocating movement between a locking position at a distal end of said guide slot and a non-locking position away from said distal end of said guide slot.

42. An over-the-needle catheter and syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger for movement between an advanced position in which a needle on the distal end of said needle holder projects from a distal end of said nozzle, and a retracted position in which said needle is retracted within said barrel;

an elastic biasing member mounted inside said barrel and contacting said needle holder for urging said needle holder toward its retracted position;

a latch releasably engageable with said needle holder and movable between a closed position in which said needle holder is latched to hold said needle holder in its advanced position against the urging of said biasing means, and an open position in which said needle holder is unlatched to allow said biasing means to move said needle holder to its retracted position;

an over-the-needle catheter; and

cooperating locking surfaces on said catheter and said syringe releasably securing said catheter to said syringe.

43. The catheter and syringe assembly of claim 42 wherein said cooperating locking surfaces include a luer taper located on said nozzle which engages with a mating luer tape located on said catheter.

44. The catheter and syringe assembly of claim 42 said catheter further including a valve.

45. The catheter and syringe assembly of claim 44 wherein said valve comprises a slit valve.

46. The catheter and syringe assembly of claim 44 wherein said valve comprises a rotary ball valve.

47. The catheter and syringe assembly of claim 42 wherein said catheter comprises a catheter body, and an elongated, generally cylindrical catheter tip extending from said body.

48. The catheter and syringe assembly of claim 47 and further including a slit valve in said catheter body.

49. The catheter and syringe assembly of claim 42 wherein said catheter comprises a pair of orthogonally disposed catheter body portions, an elongated projecting catheter tip aligned with one of said body portions and a valve for operatively coupling said catheter body portions with said tip.

50. The catheter and syringe assembly of claim 49 wherein said valve comprises a rotary ball valve.

51. A syringe assembly comprising:

an elongated, generally cylindrical barrel forming a hollow nozzle located at the distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in the said barrel and forming a longitudinal channel;

a needle holder slidably mounted in said longitudinal open channel of the said plunger and having a lateral arm;

latching means for latching and unlatching said lateral arm of said needle holder with the needle holder distally advanced relative to the barrel; and

elastic means located in said barrel for retracting said needle holder within the barrel in response to the unlatching of the needle holder from said barrel.

52. The syringe assembly of claim 51 and further including guide means forming a guide slot extending along a proximal end portion of said barrel for engaging said lateral arm of said needle holder.

53. The syringe assembly of claim 51 and further including guide means forming a helical guide slot extending along a proximal end portion of said barrel for engaging said lateral arm of said needle holder.

54. The syringe assembly of claim 51 wherein said latching means comprises a needle holder locking element slidably mounted on said barrel for reciprocating movement between a locking position and a non-locking position.

55. The syringe assembly of claim 51 wherein the barrel and plunger have cooperating interlocking elements which engage and lock when the plunger is fully advanced relative to the barrel, to prevent retraction of the plunger.

65. The syringe assembly of claim 51, wherein said channel of said plunger has locking detent means that hold the needle holder at the proximal end of the plunger when retracted.

73. The syringe assembly of claim 52 wherein said longitudinal open channel and said guide slot have detents for retaining said needle holder lateral arm at a proximal end thereof when said needle holder is retracted to thereby render the syringe assembly interlocked and inoperative.

56. A syringe assembly comprising:

an elongated, generally cylindrical barrel forming a hollow nozzle located at the distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in the said barrel and forming a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of the said plunger and having a lateral arm;

latching means for latching and unlatching said lateral arm of said needle holder relative to the barrel; and

elastic means located in the proximal end portion of said barrel and responsive to unlatching of the needle holder from said barrel for retracting said needle holder within the barrel.

57. The syringe assembly of claim 56 wherein the barrel includes an outwardly extending finger flange, and said latching means include a movable lever in the flange to capture the lateral arm of said needle holder that extends adjacent to the flange.

58. The syringe assembly of claim 56 which includes a hollow needle attached to the distal end of said needle holder.

59. The syringe assembly of claim 56 wherein a guide slot is formed in the wall of the barrel and extends radially through the wall of the barrel.

60. The syringe assembly of claim 56 wherein the elastic means comprises a spring and a proximal portion of the barrel has an internally projecting surface for directly or indirectly supporting a distal end of said spring.

61. The syringe assembly of claim 56 wherein the elastic means comprises a spring and a bracket at a proximal end portion of the barrel supports a distal end of the spring.

62. The syringe assembly of claim 56 wherein the proximal portion of the barrel containing the elastic retraction means has a larger inside diameter than the distal portion of the barrel to define said projecting surface at a shoulder formed at the transition between the proximal and distal barrel portions.

66. The syringe assembly of claim 56, wherein said channel of said plunger has locking detent means that hold the needle holder at the proximal end of the plunger when retracted.

67. A syringe assembly, comprising:

an elongated generally cylindrical barrel forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and forming a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger;

a latch that releasably couples the needle holder with the barrel; and

an elastic spring located in a proximal end portion of said barrel for retracting said needle holder within the open channel in response to release of said latch.

68. The syringe assembly of claim 67 wherein said barrel includes an internally projecting support ring for seating one of the elastic spring and a support element for supporting said elastic spring, said elastic spring being compressed by the needle holder when the needle holder is coupled to the barrel by the latch.

69. The syringe assembly of claim 67 including a bracket projecting into said barrel for supporting a distal end of said elastic spring, said elastic spring being compressed when the latch is unreleased and expanding to its full uncompressed length when the latch is released.

70. The syringe assembly of claim 67 wherein said barrel includes a finger flange to facilitate gripping of the barrel and said latch comprises a sliding lever mounted to said finger flange and removably projecting into the plunger open channel to releasably latch the needle holder to the barrel.

71. The syringe assembly of claim 67 wherein said latch comprises a needle holder locking element slidably mounted on said barrel for reciprocating movement between a locking position and non-locking position.

72. The syringe assembly of claim 67 wherein said nozzle has a male luer taper on an outer surface thereof.

74. The needle-syringe assembly of claim 67 wherein said plunger open channel includes a plurality of detent elements formed as integral parts of an interior surface of said open channel for retaining the needle holder in sliding engagement with said open channel.

75. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and forming a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger;

guide slot means defining a guide slot extending along a proximal end portion of said barrel for guiding a retracting motion of said needle holder within the barrel in response to a retractile force between the barrel and the needle holder; and

latching means on said barrel for latching and unlatching said needle holder at the distal end of said guide slot.

76. The syringe assembly of claim 75 wherein said guide slot has latching means at a distal end thereof for releasably latching said needle holder against said retractable force, and detent means for interlocking the barrel, plunger and needle holder at a proximal end.

77. A syringe assembly, of claim 75 including latching means on said barrel for releasably latching said needle holder against said retractable force, and comprising a locking element formed as an integral part of the outer surface of said barrel and including an integral hinge for permitting pivoting movement of said locking element between a locking position, and a non-locking position.

78. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and forming a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger and having a lateral arm;

means defining a guide slot extending along a proximal end portion of said barrel for engaging said lateral arm of needle holder and guiding said needle holder within the barrel in response to relative movement between the barrel and the needle holder;

latching means on said barrel for latching and unlatching said needle holder at a distal end of said guide slot, and comprising a locking tab hingedly joined to said barrel and movable between a locking position in engagement with said lateral arm of said needle holder at said distal end of said guide slot and a non-locking position out of engagement with said lateral arm of said needle holder; and

retractable force providing means coupled with said needle holder for applying a force thereto for causing said relative movement between said barrel and said needle holder in a direction for retracting said needle holder within said barrel.

79. The syringe assembly of claim 78 wherein the retractable force providing means is a coil spring.

80. A method of assembling a safety syringe assembly comprising, in sequence:

providing a barrel, a plunger having a longitudinal open channel, a needle holder which mounts a needle at a distal end thereof, a plunger cap, and a helical coil compression spring;

axially inserting a plunger cap and said needle holder with said compression spring thereabout into said barrel;

aligning said channel portion of said plunger with said needle holder;

axially inserting said plunger into the barrel; and

applying longitudinal force on said plunger for causing said plunger to advance into said barrel and cause latching of said needle holder to said barrel and sliding engagement of said needle holder with said plunger channel.

81. The method of syringe assembly of claim 80 wherein said needle holder includes a lateral arm for engaging a guide slot in said barrel and said barrel has an open end and said plunger includes recesses alignable with said open end of said barrel for defining a relief space for deformation of said open end of barrel to permit initial insertion of said lateral arm of said needle holder past said open end of said barrel into said guide slot, and further including deforming said open end of said barrel and simultaneously inserting said lateral arm of said needle holder past said open end of said barrel and into said guide slot.

82. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and having a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger for movement between an advanced position in which a needle on the distal end of said needle holder projects from a distal end of said nozzle, and a retracted position in which said needle is retracted within said barrel;

an elastic biasing member mounted inside said barrel and contacting said needle holder for urging said needle holder toward its retracted position; and

a latch releasably engageable with said needle holder and movable between a closed position in which said needle holder is latched to hold said needle holder in its advanced position against the urging of said biasing means, and an open position in which said needle holder is unlatched to allow said biasing means to move said needle holder to its retractable position.

83. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and forming a longitudinal open channel;

a needle holder slidably mounted in said longitudinal open channel of said plunger;

retracting means for retracting said needle holder relative to the open channel in response to a retractile force between the barrel and the needle holder; and

latching means on said barrel for latching and unlatching said needle holder.

84. A syringe assembly, comprising:

an elongated, generally cylindrical barrel having a hollow interior forming a hollow nozzle located at a distal end of said barrel and opening into the interior of said barrel;

a plunger slidably mounted in said barrel and forming a longitudinal open channel;

a needle holder slidable mounted in said longitudinal open channel of said plunger and having a lateral arm;

a guide slot in said barrel for engaging said lateral arm of needle holder and guiding said needle holder within the barrel in response to relative movement between the barrel and the needle holder;

latching means on said barrel for latching and unlatching said needle holder; and

retractable force providing means coupled with said needle holder for applying a force thereto for causing said relative movement between said barrel and said needle holder in a direction for retracting said needle holder.