Needle guide

• US 7,059,368 B2
• Filed: 11/04/2004
• Issued: 06/13/2006
• Est. Priority Date: 02/20/2004
• Status: Expired due to Fees

• Current Assignee: Point Guard Medical Incorporated
• Original Assignee: Point Guard Medical Incorporated
• Inventors: Filler, Aaron G.
• Primary Examiner(s): Douglas, Steven O.
• Application Number:
  US10/982,713
• Publication Number:
  US 20050187533A1
• Time in Patent Office: 586 Days
• Field of Search: 141/329, 141/330, 141 21- 27, 604/416
• US Class Current: 141/329
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/085 Protection against injuring the user
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02

Abstract

A needle guide for decreasing the incidence of needle injury to an operator who is accessing the interior of a container, such as a medical fluid container, by an accessing device, such as a syringe with a needle attached to the distal end of the syringe. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the device comprising a container, such as a medical fluid container, with an integrated needle guide. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container, such as a medical fluid container, by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the method comprising providing a needle guide according to the present invention, or providing a device comprising a container with an integrated needle guide according to the present invention.

Claims

1. A needle guide for decreasing the incidence of needle injury to an operator who is accessing the interior of a container, such as a medical fluid container, by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the needle guide comprising:

a proximal portion comprising a proximal end that is at least partly open and comprising a distal end; and

a distal portion connected to the proximal portion, the distal portion comprising a proximal end and comprising a distal end that is at least partly open;

where the proximal portion comprises an inner surface that tapers from the proximal end of the proximal portion to the distal end of the proximal portion;

where the distal portion comprises an inner surface that is continuous with the inner surface of the proximal portion though an opening; and

where the distal portion is configured such that the inner surface of the distal portion fits snugly over part or all of the container to be accessed.

2. The needle guide of claim 1, where the proximal portion has a substantially conical shape with the larger end proximally and the narrow end distally.

3. The needle guide of claim 1 further comprising one or more than one seal, sealing the proximal end of the proximal portion and sealing the distal end of the distal portion of the needle guide to maintain sterility of the inner surface of the proximal portion and the inner surface of the distal portion of the needle guide prior to use.

4. The needle guide of claim 3, where the seal is a metal foil removably attached to the lip of the proximal portion by an adhesive.

5. The needle guide of claim 3, where the seal is a wrapping covering the entire needle guide.

6. The needle guide of claim 3, where the seal is resealable.

7. The needle guide of claim 3, where the seal comprises a first layer and a second layer, and further comprises a sterilizing pad between the first layer and the second layer.

8. The needle guide of claim 1, where the proximal portion and the distal portion of the needle guide are configured to be separable from one another by the operator.

9. The needle guide of claim 8, where the distal end of the proximal portion comprises a mechanism that mates with a companion mechanism on the proximal end of the distal portion device.

10. The needle guide of claim 9, where the mechanism on the proximal portion and the mechanism on the distal portion are interlocking screw-type mechanisms.

18. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container by an accessing device, the method comprising:

a) providing a container comprising a proximal portion and comprising a distal storage portion whose interior is to be accessed, and providing a needle guide according to claim 1;

b) inserting the distal portion of the needle guide over the proximal portion of the container until that the distal end of the proximal portion of the needle guide contacts or comes in close proximity to the proximal portion of the container;

c) providing an accessing device comprising a needle at the distal end; and

d) inserting the needle through the proximal portion of the needle guide and through the proximal portion of the container, thereby accessing the distal storage portion of the container.

19. The method of claim 18, where the proximal portion of the container comprises a seal, and where the method further comprises removing the seal.

20. The method of claim 18, where the distal end of the distal portion of the needle guide comprises a seal, and where the method further comprises removing the seal.

21. The method of claim 18, where the proximal end of the proximal portion of the needle guide comprises a seal, and where the method further comprises removing the seal.

22. The method of claim 21, further comprising resealing the proximal end of the proximal portion of the needle guide.

23. The device of claim 21, where the seal comprises a first layer and a second layer, and further comprises a sterilizing pad between the first layer and the second layer, and where the method further comprises removing the first layer of the seal to access the sterilizing pad, and then using the sterilizing pad to sterilize part of the container to be contacted with the needle from the accessing device.

24. The method of claim 18, further comprising withdrawing material from the container through the needle or introducing material into the container from the accessing device.

25. The method of claim 18, further comprising withdrawing the needle from the proximal portion of the container, and from the needle guide.

26. The method of claim 18, where the container is a “

snap-open”

type of medical fluid container comprising a breakable junction between the proximal portion and the distal storage portion; and

where the method further comprises separating the proximal portion of the container from the distal storage portion of the container by breaking the container at the junction.

27. The method of claim 18, where the container is a “

snap-open”

type of medical fluid container comprising a breakable junction between the proximal portion and the distal storage portion;

where the proximal portion and the distal portion of the needle guide are configured to be separable from one another by the operator; and

where the method further comprises inserting distal portion of needle guide over the distal storage portion of the container before separating the proximal portion from the distal storage portion by breaking the container at the junction, separating the distal storage portion of the container from the proximal portion by breaking the container at the junction, removing the distal storage portion, and then joining the proximal portion of the needle guide to the distal portion of the needle guide.

11. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, the device comprising:

a container comprising a proximal portion and a distal storage portion; and

a needle guide comprising a proximal portion with a proximal end and a distal end, and comprising a distal portion, where the distal portion of the needle guide is integrally attached to the proximal portion of container; and

where the proximal portion of the needle guide tapers from the proximal end to the distal end.

12. The device of claim 11, where the proximal portion of the needle guide has a substantially conical shape with the larger end proximally and the narrow end distally.

13. The device of claim 11, where the proximal portion of the needle guide has an inner surface, and further comprising a seal, sealing the proximal end of the proximal portion of the needle guide to maintain sterility of the inner surface of the proximal portion prior to use.

14. The device of claim 13, where the seal is a metal foil removably attached to the lip of the proximal portion of the needle guide by an adhesive.

15. The device of claim 13, where the seal is a wrapping covering the entire device.

16. The device of claim 13, where the seal is resealable.

17. The device of claim 13, where the seal comprises a first layer and a second layer, and further comprises a sterilizing pad between the first layer and the second layer.

28. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container, such as a medical fluid container, by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the method comprising:

a) providing a device according to claim 11;

b) providing an accessing device comprising a needle at the distal end; and

c) inserting the needle through the proximal portion of the needle guide and through the proximal portion of the container, thereby accessing the distal storage portion of the container.

29. The method of claim 28, where the proximal end of the proximal portion of the needle guide comprises a seal, and where the method further comprises removing the seal.

30. The method of claim 29, further comprising resealing the proximal end of the proximal portion of the needle guide.

31. The method of claim 28, further comprising withdrawing material from the container through the needle or introducing material into the container from the accessing device.

32. The method of claim 28, further comprising withdrawing the needle from the proximal portion of the container and from the needle guide.

33. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the device comprising:

a base comprising a center and a periphery, and comprising a proximal side and a distal side; and

a plurality of supports attached to the base extending generally perpendicular to the base and oriented circumferentially around the periphery of the proximal side of the base;

where the base and supports are configured generally to retain the container; and

where the base is magnetic and of sufficient strength and configuration to attract a needle approaching the base from proximal to the supports toward the center of the base.

34. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container comprising a proximal portion and a distal storage portion to be accessed, by an accessing device comprising a needle at the distal end, the method comprising:

a) providing a device according to claim 33;

b) placing the container between the supports;

c) providing the accessing device; and

d) inserting the needle through the proximal portion of the container, thereby accessing the distal storage portion of the container.

35. The method of claim 34, further comprising withdrawing material from the container through the needle or introducing material into the container from the accessing device.

36. The method of claim 34, further comprising withdrawing the needle from the proximal portion of the container.

37. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, such as a syringe with a needle attached to the distal end of the syringe, the device comprising:

a proximal actuating portion; and

a distal retaining portion connected to the proximal actuating portion;

where the proximal actuating portion is configured to reversibly open and close the distal retaining portion;

where the distal retaining portion comprises a magnet of sufficient strength and configuration to attract a needle approaching the distal retaining portion and to guide the needle toward the center of the distal retaining portion; and

where the distal retaining portion is configured to grasp the container.

38. The device of claim 37, where the distal retaining portion comprises a plurality of arms.

39. The device of claim 38, where the arms form an incomplete circular enclosure.

40. The device of claim 38, where the arms form a cylinder.

41. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container comprising a proximal portion and a distal storage portion to be accessed, by an accessing device comprising a needle at the distal end, the method comprising:

a) providing a device according to claim 37;

b) providing the container to be accessed;

c) actuating the distal retaining portion to grasp the proximal portion of the container with the distal retaining portion;

d) providing the accessing device; and

e) inserting the needle through the proximal portion of the container, thereby accessing the distal storage portion of the container.

42. The method of claim 41, further comprising withdrawing material from the container through the needle or introducing material into the container from the accessing device.

43. The method of claim 41, further comprising withdrawing the needle from the proximal portion of the container.

44. The method of claim 41, further comprising sterilizing the distal retaining portion prior to actuating the distal retaining portion.

45. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, the device comprising:

a proximal portion comprising a center and a periphery; and

a distal portion attached to the proximal portion, and comprising a center and a periphery;

where the proximal portion comprises magnetic particles in a configuration more dense around the periphery and less dense in the center; and

where the distal portion is configured to fit snugly into the proximal opening of the container.

46. The device of claim 45, where the distal portion comprises magnetic particles in a configuration more dense around the periphery and less dense in the center.

47. The device of claim 45, where the magnetic particles are embedded directly into the proximal portion.

48. The device of claim 45, where the proximal portion comprises a washer with the magnetic particles embedded into the washer, and where the washer is attached to or embedded directly in the proximal portion.

49. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a container comprising a proximal portion and a distal storage portion to be accessed, by an accessing device comprising a needle at the distal end, the method comprising:

a) providing a device according to claim 45;

b) providing the container to be accessed;

c) introducing the distal portion of the device into the proximal portion of the container, thereby substantially sealing the proximal portion of the container;

d) providing the accessing device; and

e) inserting the needle through the proximal portion of the device and into the container.

50. The method of claim 49, further comprising withdrawing material from the container through the needle or introducing material into the container from the accessing device.

51. The method of claim 49, further comprising withdrawing the needle from the proximal portion of the container.

52. A device for decreasing the incidence of needle injury to an operator who is accessing the interior of the container by an accessing device, the device comprising:

a proximal portion and a distal storage portion attached to the proximal portion; and

a needle guide comprising a center and a periphery;

where the needle guide is integrally attached to the proximal portion and seals the proximal portion of the device; and

where the needle guide comprises magnetic particles in a configuration more dense around the periphery and less dense in the center.

53. The device of claim 52, further comprising a seal covering the needle guide to maintain sterility of the needle guide before use.

54. A method of decreasing the incidence of needle injury to an operator who is accessing the interior of a device comprising a proximal portion and a distal storage portion to be accessed, by an accessing device comprising a needle at the distal end, the method comprising:

a) providing a device according to claim 52;

b) providing the accessing device; and

c) inserting the needle through the needle guide of the device, thereby accessing the distal storage portion.

55. The method of claim of claim 54, where the device provided further comprises a seal covering the needle guide to maintain sterility of the needle guide before use, and where the method further comprises removing the seal.

56. The method of claim 54, further comprising withdrawing material from the device through the needle or introducing material into the device from the accessing device.

57. The method of claim 54, further comprising withdrawing the needle from the device.