Needle shield

• US 5,098,400 A
• Filed: 02/14/1991
• Issued: 03/24/1992
• Est. Priority Date: 02/14/1991
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: Goodsir, Stephen W., Crouse, Roger L., McCormick, Paul Y.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Finkel, Sharon
• Application Number:
  US07/655,873
• Time in Patent Office: 404 Days
• Field of Search: 604/192, 604/197, 604/198, 604/199, 604/263
• US Class Current: 604/192
• 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/3213 Caps placed axially onto the needle, e.g. equipped with finger protection guards axially-extensible protective sleeves A61M5/3243

Abstract

The present invention relates to a shield for use on a prefilled hypodermic syringe assembly. The shield is intended to be retrofitable over a sheath/needle sub-assembly of the hypodermic syringe assembly in such a manner that insertion of the sheath/needle sub-assembly into the shield can be simply and easily accomplished by a medical worker, and subsequent extraction of the sheath from the shield is prevented by retention members which are formed from the housing of the shield, and which protrude into the chamber to hold the sheath. The retention member are formed so as to allow the sheath to be easily slidable into the chamber of the shield, yet engage the exterior surface of the sheath to resist extraction thereof once the sheath has engaged the retention members. Also disclosed are unique method of manufacturing the sheath of the present invention along with preferred methods of use thereof.

Claims

1. A shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering a distal portion of a needle cannula, said shield comprising:

a relatively rigid housing forming an elongate chamber therein, said chamber forming an open proximal end, and said chamber and said open proximal end having cross-sectional areas sized to allow the sheath/needle sub-assembly to be inserted through said open proximal end and into said chamber; and

retention means formed as a part of said housing and permanently located within said chamber away from said open proximal end, for locking the sheath within said chamber to prevent separation of the sheath from said shield when the needle cannula is removed from the sheath, said retention means including at least one retention member having a sliding surface and a barbed end;

whereby said shield is easily positionable over the sheath/needle sub-assembly, and said sliding surface contacts the sheath during insertion thereof, and the sheath, when engaged within said shield, is easily removable from the needle cannula by removing said sheath, and said barbed end functions to grip and retain the sheath against subsequent retraction of the sheath from said chamber.

2. A shield according to claim 1 wherein said retention means forms an effective cross-sectional area of said chamber which is less than the cross-sectional area of the sheath.

3. A shield according to claim 2 wherein said retention means includes at least one retention member projecting into said chamber and functioning to allow movement of the sheath/needle sub-assembly into said chamber and subsequently to automatically inhibit movement of the sheath out of said chamber.

4. A shield according to claim 3 wherein said at least one retention member is relatively resilient when subjected to forces thereagainst caused by the sheath/needle sub-assembly as it is inserted into said shield, and relatively rigid when subjected to forces thereagainst caused by the sheath during attempted retraction thereof from said shield.

5. A shield according to claim 1 wherein said at least one retention member is located directly adjacent to and partially forms an opening extending through said housing into said chamber.

6. A shield according to claim 5 wherein said housing is formed of a generally cylindrical outer surface and said chamber is formed of a generally cylindrical inner surface.

7. A shield according to claim 6 wherein said housing includes a plurality of reinforcement ribs integrally formed with an extending longitudinally along said cylindrical outer surface of said housing.

8. A shield according to claim 7 wherein said opening formed at least partially by said at least one retention member is located between at least two of said plurality of reinforcement ribs.

9. A shield according to claim 3 including a plurality of said retention members, said plurality of retention members forming at least one set of retention members spaced uniformly about a circumference of said chamber.

10. A shield according to claim 9 including at least two of said sets of retention members, each of said sets being located at a different longitudinal position along said chamber, whereby said shield is adapted to receive and retain sheath/needle sub-assemblies of varying lengths.

11. A shield according to claim 2 wherein said cross-sectional area of said chamber is a circular area and said effective cross-sectional area is an effective circular area formed by said retention means.

12. A shield according to claim 11 wherein said circular area is approximately 0.20 inches in diameter and said effective circular area is approximately 0.15 inches in diameter.

13. A shield according to claim 1 wherein said elongate chamber further includes a closed distal end.

14. A shield according to claim 13 further including stop means located adjacent said distal end of said chamber, for abutment against a distal end of the sheath to prevent insertion of the sheath beyond said stop means.

15. A shield according to claim 14 wherein said closed distal end of said chamber comprises a enclosure means affixed to said housing, said stop means being integrally formed with said plug means.

16. A shield according to claim 1 wherein said housing is formed of a generally cylindrical outer surface and said chamber is formed of a generally cylindrical inner surface.

17. A shield according to claim 16 wherein said cylindrical outer surface includes a plurality of reinforcement ribs integrally formed with and extending longitudinally along said cylindrical outer surface of said housing.

18. A shield according to claim 1 further including flange means integrally formed with and extending radially outward from said housing at a location adjacent said open proximal end of said chamber.

19. A shield according to claim 1 made from polypropylene.

20. A shield according to claim 1 wherein said chamber includes an open distal end.

21. A shield according to claim 20 further including stop means located in said chamber adjacent said opened distal end, for abutment with a distal end of the sheath for preventing insertion of the sheath beyond said stop means.

22. A shield according to claim 21 wherein said stop means is integrally formed with said housing and extends into said chamber at a location adjacent said open distal end.

23. A method of using a shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering the distal portion of a needle cannula, said sheath including a relatively rigid housing forming an elongate chamber therein, the chamber having an open proximal end and a retention means including at least one retention member permanently located within said chamber and away from the chamber open end and formed as a part of the housing, for locking the sheath within the chamber to prevent separation of the sheath from the chamber when the needle cannula is removed, said at least one retention member including a sliding surface and a barbed end, said method of using the shield comprising the steps of:

inserting the sheath/needle sub-assembly through the open proximal end of the chamber until the sheath engages and slides along the sliding surface of the at least one retention member;

removing the sheath from the needle cannula by removing the shield while the retention means holds the sheath in locked position therein, the barbed end of the at least one retention member gripping and retaining the sheath against subsequent retraction of the sheath from the chamber.

24. A method according to claim 23 further including the step of:

replacing the sheath with the shield affixed thereabout, over the needle cannula.

25. A method according to claim 24 further including the step of:

removing the hypodermic syringe assembly from a sterile package prior to inserting the sheath/needle sub-assembly thereof into the shield.

26. A method according to claim 23 wherein the shield includes a plurality of retention members forming at least two sets of retention members, each set of retention members including a plurality of retention members space uniformly about a circumference of the chamber and each set of retention members is located at a different longitudinal position along the chamber, said step of inserting the sheath/needle sub-assembly into the chamber further includes engaging at least one of the sets of retention member with the sheath.

27. A method according to claim 26 wherein said step of engaging the sheath with the retention members includes engaging said sheath with only one set of retention members.

28. A method according to claim 26 wherein said step of engaging the sheath with the retention members includes engaging the sheath with at least two sets of retention members.

29. A method according to claim 23 wherein the chamber is cylindrical in shape having a circular cross-sectional area through which the sheath must pass during insertion, and the retention means forms an effective cross-sectional area which is less than the cross-sectional area of the chamber and less than the cross-sectional area of the sheath, said step of inserting the sheath/needle sub-assembly into the chamber further includes the step of resiliently deforming the sheath as it passes beyond the retention means during insertion thereof into the chamber.

30. A method according to claim 23 wherein the shield further includes stop means located adjacent the distal end of the chamber and said method further includes the step of abutting a distal end of the sheath against the stop means at the completion of said inserting step, the stop means functioning to prevent further insertion of the sheath into the chamber beyond the stop means.

31. A method of making a shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering a distal portion of a needle cannula, said method of making the shield comprising the steps of:

forming a relatively rigid housing with an elongate chamber therein, with the chamber being formed with an open proximal end, the open proximal end of the chamber being formed to a size sufficient to allow the sheath/needle sub-assembly to be insertable therethrough into the chamber; and

forming a retention means within the chamber away from the open proximal end for locking the sheath within the chamber when the shield is positioned thereover, said step of forming a retention means includes forming at least one retention member having a sliding surface and a barbed end, said sliding surface of said at least one retention member contacting the sheath during insertion thereof and being relatively resilient when subjected to forces thereagainst caused by the sheath/needle sub-assembly as it is inserted into the shield, and said barbed end of said at least one retention member being relatively rigid when subjected to forces thereagainst caused by the sheath during attempted retraction thereof from the shield, the barbed end functioning to grip and retain the sheath within the chamber.

32. A method according to claim 31 wherein the step of forming a retention means includes forming at least one retention member which projects into the chamber.

33. A method according to claim 32 wherein said step of forming at least one retention member includes forming a plurality of retention members which comprise a set of retention members which are spaced uniformly about a circumference of the chamber.

34. A method according to claim 33 wherein said step of forming at least one set of retention members further includes forming two sets of retention members, each set being located at a different longitudinal position along the chamber.

35. A method according to claim 31 wherein said step of forming a relatively rigid housing with an elongate chamber therein includes forming the chamber into a generally cylindrical shape.

36. A method according to claim 35 wherein said step of forming the chamber into a cylindrical shape includes forming the chamber to a diameter of approximately 0.20 inches, and said step of forming a retention means in the chamber includes forming the retention means within the chamber which have an effective cross-sectional diameter of approximately 0.15 inches.

37. A method according to claim 31 wherein said step of forming a relatively rigid housing includes forming a closed distal end in the elongated chamber formed by the housing.

38. A method according to claim 31 wherein said step of forming a relatively rigid housing with an elongate chamber therein further includes forming stop means within the elongated chamber whereby a stop means can contact a distal end of a sheath when inserted into the chamber and prevent insertion of the sheath beyond the stop means.

39. A method according to claim 37 wherein said step of forming a relatively rigid housing with an elongate chamber includes forming a enclosure means to close a distal end of a chamber, and further includes forming stop means integrally with the enclosure means, for contact of a distal end of a sheath to prevent insertion of the sheath beyond the stop means.

40. A method according to claim 31 further including the stop of forming flange means integrally with, and extending radially outward from, the housing at a location adjacent the open proximal end of the chamber.

41. A method according to claim 31 wherein the shield is formed from polypropylene.

42. A method according to claim 31 wherein said step of forming an elongate chamber within the relatively rigid housing includes forming the chamber with an open distal end.

43. A method according to claim 42 including the further steps of a plug means sized to cover the open distal end of the chamber, said step of forming the plug means including forming stop means integrally covering the open distal end of the chamber with the plug means such that the stop means are located within the chamber.

44. A method according to claim 31 wherein said step of forming a retention means includes forming at least one retention member by piercing through the housing of the shield into the chamber thereof to force a portion of the housing into the chamber to form the retention member.

45. A method according to claim 44 wherein said step of forming a relatively rigid housing includes forming the housing of a generally cylindrical outer surface and forming the chamber of a generally cylindrical inner surface, and forming a plurality of reinforcement ribs integrally with, and extending longitudinally along, the cylindrical outer surface of the housing.

46. A method according to claim 44 wherein said step of piercing the housing to form a retention member includes piercing the housing in a plurality of locations to form a plurality of retention members.

47. A method according to claim 46 wherein the step of forming a plurality of retention members includes forming at least one set of retention members circumferentially about the chamber wall in uniform spaced apart relationship.

48. A method according to claim 47 wherein said step of forming a plurality of retention members includes forming the retention members in between the reinforcement ribs.

51. A shield according to claim 46 wherein said step of forming at least one retention member includes forming a plurality of retention members which comprise a set of retention members which are spaced uniformly about a circumference of the chamber.

52. A shield according to claim 51 wherein said step of forming at least one set of retention members further includes forming two sets of retention members, each set being located at a different longitudinal position along the chamber.

49. A shield for insertion over and retention of a sheath of a hypodermic syringe assembly which has been formed by the process of:

forming a relatively rigid housing having an elongate chamber therein, the chamber being formed with an open proximal end which is sized to allow a sheath/needle sub-assembly of the hypodermic syringe assembly to be insertable therethrough into the chamber; and

forming a retention means within the chamber away from the open proximal end for retaining and locking the sheath within the chamber when the shield is positioned thereover, said step of forming at least one retention including forming a sliding surface and a barbed end on the at least one retention member whereby the sliding surface can contact the sheath during insertion thereof and the barbed end can grip and retain the sheath against subsequent attempts to retract the sheath from the chamber.

50. A shield according to claim 49 wherein the step of forming a retention means includes forming at least one retention member which projects into the chamber.

53. A shield according to claim 49 wherein said step of forming a relatively rigid housing with an elongate chamber therein includes forming the chamber into a generally cylindrical shape.

54. A shield according to claim 53 wherein said step of forming the chamber into a cylindrical shape includes forming the chamber to a diameter of approximately 0.20 inches, and said step of forming a retention means in the chamber includes forming the retention means within the chamber which have an effective cross-sectional diameter of approximately 0.15 inches.

55. A shield according to claim 49 wherein said step of forming a retention means includes forming at least one retention member which is relatively resilient when subject to forces thereagainst caused by the sheath/needle subassembly as it is inserted into the shield and relatively rigid when subjected to forces thereagainst caused by the sheath during attempted retraction thereof from the shield.

56. A shield according to claim 49 wherein said step of forming a relatively rigid housing includes forming a closed distal end in the elongated chamber formed by the housing.

57. A shield according to claim 49 wherein said step of forming a relatively rigid housing with an elongate chamber therein further includes forming stop means within the elongated chamber whereby a stop means can contact a distal end of a sheath when inserted into the chamber and prevent insertion of the sheath beyond the stop means.

58. A shield according to claim 56 wherein said step of forming a relatively rigid housing with an elongate chamber includes forming a enclosure means to close a distal end of a chamber, and further includes forming stop means integrally with the enclosure means, for contact of a distal end of a sheath to prevent insertion of the sheath beyond the stop means.

59. A shield according to claim 49 further including the stop of forming flange means integrally with, and extending radially outward from, the housing at a location adjacent the open proximal end of the chamber.

60. A shield according to claim 49 wherein the shield is formed from polypropylene.

61. A shield according to claim 49 wherein said step of forming an elongate chamber within the relatively rigid housing includes forming the chamber with an open distal end.

62. A shield according to claim 61 including the further steps of a plug means sized to cover the open distal end of the chamber, said step of forming the plug means including forming stop means integrally covering the open distal end of the chamber with the plug means such that the stop means are located within the chamber.

63. A shield according to claim 49 wherein said step of forming a retention means includes forming at least one retention member by piercing through the housing of the shield into the chamber thereof to force a portion of the housing into the chamber to form the retention member.

64. A shield according to claim 63 wherein said step of forming a relatively rigid housing includes forming the housing of a generally cylindrical outer surface and forming the chamber of a generally cylindrical inner surface, and forming a plurality of reinforcement ribs integrally with, and extending longitudinally along, the cylindrical outer surface of the housing.

65. A shield according to claim 63 wherein said step of piercing the housing to form a retention member includes piercing the housing in a plurality of locations to form a plurality of retention members.

66. A shield according to claim 65 wherein the step of forming a plurality of retention members includes forming at least one set of retention members circumferentially about the chamber wall in uniform spaced apart relationship.

67. A shield according to claim 66 wherein said step of forming a plurality of retention members includes forming the retention members in between the reinforcement ribs.

68. A method of using a shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering the distal portion of a needle cannula, said sheath including a relatively rigid housing forming an elongate chamber therein, the chamber being cylindrical in shape having a circular cross-sectional area through which the sheath must pass during insertion and including an open proximal end, and a retention means including a plurality of tension member located from the chamber open end and formed as part of the housing, the retention members including a sliding surface and a barbed end and being relatively resilient when subjected to forces there against caused by the sheath/needle sub-assembly as it is inserted into the shield and relatively rigid when subjected to forces there against caused by the sheath during attempted retraction thereof from the shield, the retention means forming an effective cross-sectional area which is less the cross-sectional area of the chamber and less than the cross-sectional area of the sheath, said method of using the shield comprising the steps of:

inserting the sheath/needle sub-assembly through the open proximal end of the chamber,

contacting the sheath and the sliding surface of the retention members during insertion of the sheath into the chamber and resiliently deforming the sheath as it passes beyond the retention means during insertion thereof into the chamber,

removing the sheath from the needle cannula by removing the shield while the barbed end of the retention members contacts and grips the sheath to retain the sheath against subsequent retraction thereof from the chamber.