Accessing and deaccessing tools and methods

• US 6,673,091 B1
• Filed: 11/24/1999
• Issued: 01/06/2004
• Est. Priority Date: 05/24/1996
• Status: Expired due to Fees

• Current Assignee: Jeanette Perlick, Robert Burns, Terry Shaffer
• Original Assignee: Jeanette Perlick, Robert Burns, Terry Shaffer
• Inventors: Burns, Robert, Shaffer, Terry, Perlick, Jeanette
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/424,709
• Time in Patent Office: 1,504 Days
• Field of Search: 604/115, 604/116, 606/201, 606/1, 600/201, 600/210
• US Class Current: 606/201
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• 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 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A tool is used to assist in the manual insertion and removal of a needle into a medical device implanted under the skin of a patient. The tool includes an elongated body having a handle section and an enlarged guard section with an elongated slot extending from an edge of the guard section into the guard section, terminating at an internal portion of the guard section. Preferably, the guard section of this tool is transparent, and it has indicia thereon which assist in aligning the tool with the implanted medical device. The guard section may include a depression on its underside which overlies the implanted medical device when the guard is placed in position for accessing or deaccessing the needle.

Claims

1. A tool for assisting in accessing and deaccessing a needle, including

an elongated body having a handle section with a length of 3 inches or more and an enlarged guard section made of a transparent material and having an area of 1.0 square inch or more,

said handle section having a marker indicating that a hand of the nurse should be behind said marker, said marker being located to position the hand of the nurse at least 2.5 inches away from the needle during use, and

an elongated slot extending from an edge of the guard section into the guard section, terminating at an internal portion of the guard section.

2. The tool of claim 1 where said guard section has

a forward edge terminating at opposed ends, side edges at each opposed end which extend rearward to said handle section, and said elongated slot extending from the forward edge rearward towards said handle section,

said forward edge having a length of from 1 to 6 inches, said side edges having a length of from 0.5 to 3.0 inches, and said slot having a length of from 0.25 to 3 inches.

3. The tool of claim 2 where the slot is at a right angle with respect to the forward edge.

4. The tool of claim 2 where the minimum distance between the slot and a side edge is {fraction (3/16)} inch and the maximum distance between the slot and a side edge is 3 inches.

5. The tool of claim 1 where the slot has a width of from {fraction (1/16)} to ¼

inch.

6. The tool of claim 1 where the slot and the handle section are in substantial alignment with each other, both lying along a common longitudinal axis.

7. The tool of claim 1 where the guard section has a thickness of from {fraction (1/32)} to {fraction (3/16)} inch.

8. The tool of claim 1 where handle section includes an intermediate neck section, and said guard section is joined to the intermediate neck, said handle section and said intermediate neck being at an acute angle of from 0 to 20 degrees, and said intermediate neck section and said guard section being at an acute angle of from 10 to 40 degrees.

9. The tool of claim 1 where guard section has a smooth, generally planar underside surface.

10. The tool of claim 1 where the elongated body has a length of from 3 to 11 inches.

11. The tool of claim 1 where the slot has tapered edges.

12. The tool of claim 1 where the marker comprises a raised thumb lever.

13. The tool of claim 1 made from an injected molded polymeric material.

14. The tool of claim 13 where the polymeric material is a polypropylene or polycarbonate.

15. The tool of claim 1 where the handle section has an elongated depression therein extending lengthwise along said handle section.

16. The tool of claim 1 where the guard section has a pair of marks thereon space apart a distance approximately equal to the width of an implanted medical device.

17. A tool for accessing and deaccessing a needle used with a medical device of a predetermined configuration and implanted under the skin of a patient, including

an elongated body including a handle section and an enlarged guard section,

said guard section having an area of 1.0 square inch or more, an edge, and an underside with a depression having a configuration substantially the same as the configuration of the medical device, so that when the guard section overlies the implanted medical device and is pressed against said implanted medical device, the skin of the patient and at least a portion of the medical device are received in said depression,

an elongated slot which extends from the edge of said guard section and terminates in the guard section at in an enlarged open portion through which a needle is inserted when accessing the implanted medical device.

18. The tool of claim 17 where the enlarged open portion has an area in excess of 0.0036 square inch.

19. The tool of claim 17 where there is indicia at least partially encompassing the enlarged open portion which assist the nurse to align the open portion with the implanted medical device.

20. The tool of claim 17 where the handle has a connector section that is attached to the guard section, with said connector section and guard section form an angle of 60 degrees or more.

21. The tool of claim 20 where the angle is between 60 and 90 degrees.

22. A method for manually removing a needle from a medical device implanted under the skin of a patient, including

grasping with one hand a handle section of a tool having a guard section having an area of 1.00 square inch or more and a slot therein,

sliding the slot along the needle to bring the guard section into an overlying relationship with the implanted medical device,

maintaining said one hand a minimum distance away from the needle of at least 2.5 inches, and

with the other hand withdrawing said needle free of the implanted medical device.

23. The method of claim 22 where the guard section is made of a transparent material.

24. The method of claim 22 where the tool includes

an elongated body having the handle section attached to the guard section,

said guard section having a forward edge terminating at opposed ends, side edges at each opposed end which extend rearward to said handle section, and an elongated slot which extends from the forward edge rearward towards said handle section,

said forward edge having a length of from 1 to 6 inches, said side edges having a length of from 0.5 to 3 inches, and said slot having a length of from 0.25 to 3 inches.

25. The method of claim 22 where said slot has a width that is slightly broader than the diameter of the needle.

26. The method of claim 22 where the tool has

an elongated body having a length of from 4 to 11 inches, said body including the handle section having a length of from 3 to 8 inches and an enlarged guard section having a length of from 0.5 to 3 inches,

said guard section having a forward edge having a length of from 1 to 6 inches, said forward edge terminating at opposed ends in side edges which extend rearward to said handle section, said side edges having a length of from 0.5 to 3 inches,

an elongated slot in the guard section which extends from the forward edge rearward towards said handle section and has a width of from {fraction (1/16)} to ¼

inch and a length of from 0.25 to 3 inches,

said slot being at a right angle with respect to the forward edge, with the slot and the handle section being in substantial alignment with each other, both lying along a common longitudinal axis,

the minimum distance between said slot and the side edges being {fraction (3/16)} inch and the maximum distance between the slot and the side edges being 3 inch.

27. A method for manually inserting a needle into a medical device implanted under the skin of a patient, including

(a) grasping with one hand a tool with a holder section and a handle section, and holding the tool by the handle section and pressing the holder section against the skin overlying the medical device,

(b) gripping the needle with the other hand and inserting said needle through said skin into the medical device, and

(c) maintaining the one hand a distance of at least 2.5 inches away from the needle as said needle is inserted into the medical device.

28. The method of claim 27 where said tool includes a handle section attached to the holder section, and said holder section has a pair of fork elements spaced apart a distance which is slightly greater than the width of the medical device.

29. The method of claim 27 where the fork elements are of equal length, each having a length of from 0.5 to 3 inch, and the holder section has a length of from 1.5 to 5 inches and the handle section has a length of from 3 to 8 inches.

30. The method of claim 27 where the tool is made from an injected molded polymeric material.

31. A method for manually inserting a needle into a medical device implanted under the skin of a patient, including

(a) grasping with one hand a tool with a transparent holder section with an open section therein providing access to the patient'"'"'s skin through which said needle is passed as said needle is inserted through said skin into the medical device, said guard section having indicia thereon for assisting in aligning the guard section with the implanted medical device,

said tool including

an elongated body including a handle section and an enlarged guard section,

said guard section having a floor made of a transparent material and having an area of from 1.00 square inch to 18 square inches,

said floor having a rear end to which the handle section is attached, opposed sides, and a forward edge,

an elongated slot which extends from the forward edge rearward towards said handle section and terminates at an end at least 0.5 inches from the forward edge,

said slot being substantially at a right angle with respect to the forward edge, with the slot and the handle section being in substantial alignment with each other, both lying along a common longitudinal axis, and

said slot having between the forward edge and the end of the slot a n enlarged open portion with an area in excess of 0.0036 square inch through which a needle is inserted when accessing the implanted medical device,

said handle section having a marker thereon indicating that a hand of the nurse should be behind said marker, said marker being a distance to position the hand of the nurse at least 2.5 inches away from the needle during use,

(b) gripping the needle with the other hand, said other hand being behind the marker, and inserting said needle through said skin into the medical device, and

(c) aligning the guard section with the implanted medical device, using the indicia to bring the guard section into an overlying relationship with the implanted medical device with the open section being approximately over the central section of the implanted medical device, and

(d) pressing the holder section against the skin overlying the medical device, covering the skin to maintain said one hand a safe distance away from the needle as said needle is inserted into the medical device.

32. A tool for accessing and deaccessing a needle, including

an elongated body including a handle section and a guard section,

said guard section having an area of 1.0 square inches or more, an edge, and an underside with a concave section having a substantially circular rim with a diameter of from {fraction (1/16)} to ½

inch, and a depth of from {fraction (1/16)} to {fraction (3/16)} inch,

an elongated slot which extends radially outward from the center of the concave section to the edge of said guard section.

33. The tool of claim 32 where the slot terminates in the guard section at in an enlarged open portion.

34. The tool of claim 33 where the enlarged open portion has an area in excess of 0.0036 square inch.

35. The tool of claim 32 where there is indicia at least partially encompassing the enlarged open portion which assist the nurse to align the open portion with the implanted medical device.

36. The tool of claim 32 where there is a receptacle member on said body in which a needle may be inserted.

37. A tool for accessing and deaccessing a needle, including

an elongated body including a handle section and a guard section molded from a polymeric material as a unitary structure,

said guard section having a substantially circular configuration with a center and an area of 1.0 square inch or more and an underside with a concave section having a center coincident with the center of the guard section and a substantially circular rim with a diameter of from {fraction (1/16)} to ½

inch, and a depth of from {fraction (1/16)} to {fraction (3/16)} inch, and

an elongated slot which extends radially outward from the center of the concave section to an edge of said guard section.

38. The tool of claim 37 where the slot terminates in the guard section at in an enlarged open portion having an area in excess of 0.0036 square inch.

39. The tool of claim 37 where there is a marker on the handle section indicating that a hand of the nurse should be behind said marker, said marker being located to position the hand of the nurse at least 2.5 inches away from the center of the concave section.

40. The tool of claim 37 where the handle section has top wall and side walls extending from the top wall substantially at a right angle with respect to the top wall, and the marker comprises a raised portion on the handle that serves as thumb lever.

41. The tool of claim 37 where the edge of said guard section is beveled.

42. The tool of claim 37 where the handle has a connector section that is attached to the guard section, with said connector section and guard section form an angle of 60 degrees or more.

43. The tool of claim 42 where the angle is between 60 and 90 degrees.