Removable sharps device for accessing a portal reservoir

• US 7,510,543 B2
• Filed: 12/28/2005
• Issued: 03/31/2009
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical MD Incorporated (ICU Medical Incorporated)
• Inventors: Michels, Lester D., Travis, Ronald G., Beling, William L.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/318,485
• Publication Number:
  US 20070149921A1
• Time in Patent Office: 1,189 Days
• Field of Search: 604/93.01, 604/110, 604/233, 604/239, 604/117, 604/131, 604/181
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A portal access device that is adapted to provide long term access to a port implanted in a patient has two major components, an infuser assembly and a safety needle insertion device. The infuser assembly has an infuser housing that can be configured into a specific shape, for example a dome. A blunt cannula is attached to and extends downwardly from the underside of the infuser housing. Also connected to the infuser housing, preferably at a side thereof, is a tubing or catheter. The safety needle inserter assembly has a base having a proximal portion that is configured to form fit over the infuser housing. At the distal portion of the base uprights are provided so that a second end of an arm, to which first end a needle or a sharp cannula is connected, may be movably and hingedly connected to the base. The sharp cannula extends from the underside of the proximal end of the arm and passes through the base by way of a bore formed at the proximal portion of the base. The bore is defined between an opening at the underside of the base and an opening at the upper surface of the base. Locking mechanisms are provided at the base uprights and the distal end of the arm so that when the arm is moved away from the base, and as the distal end of the arm pivots about the uprights, the respective locking mechanisms provided at the arm and the base would coact to lock the arm in place, to thereby maintain the tip of the needle within the bore formed in the base. To use, the safety needle inserter is placed over the infuser assembly, with the sharp cannula extending through the infuser housing and axially mating with the blunt cannula of the infuser assembly, but with the tip of the sharp cannula protruding beyond the tip of the blunt cannula. The combined needle inserter/infuser assembly is pressed down onto the skin surface of the patient so that the combination sharp/blunt cannulas penetrate the patient and puncture the self-sealing septum of a portal reservoir implanted in the patient. Once the safety needle inserter is removed from the infuser assembly, with the infuser housing septum being self-sealing, a closed fluid communication path is established between the portal reservoir and a fluid store that may be connected to the catheter of the infuser assembly. Long term access of the implanted portal reservoir is thereby achieved.

Claims

1. Apparatus comprising a base having a distal portion and a proximal portion, a cannula attached to a first end of an arm, a second end of said arm hingedly connected to the distal portion of said base so that said arm is pivotable relative to said base at its second end, one opening at an upper surface of said base and an other opening at a lower surface of said base provided at the proximal portion of said base wherethrough said cannula passes, a bore defined between said one opening at the upper surface of said base and said other opening at the lower surface of said base, a first lock mechanism provided at the distal portion of said base and a second lock mechanism provided at the second end of said arm, said first and second lock mechanisms coacting to prevent further movement of said arm relative to said base after the tip of said cannula moves past said other opening at the lower surface of said base and is within said bore.

2. Apparatus of claim 1, wherein said second lock mechanism comprises a leg extending from the second end of said arm and wherein first lock mechanism comprises a shoulder at the distal portion of said base, wherein said leg biases against said shoulder to prevent said arm from further downward movement once said arm has been pivoted to a predetermined position whereby the tip of said cannula is positioned within said bore.

3. Apparatus of claim 1, wherein said second lock mechanism comprises a boss extending from the second end of said arm and wherein said first lock mechanism comprises a groove or recess at the distal portion of said base, wherein said boss is caught in and biases against said groove or recess to prevent said arm from further upward movement once said arm has been pivoted to a predetermined position whereby the tip of said cannula is positioned within said bore.

4. Apparatus of claim 1, wherein said second lock mechanism comprises a leg extending from one side of said arm and a boss extending from another side of said arm, and said first lock mechanism comprises a shoulder at one side of the distal portion of said base and a groove or recess provided at an upright at another side of the distal portion of said base;

and

wherein when said arm is pivoted upwards relative to said base to a predetermined position whereby the tip of said cannula is positioned within said bore, said leg biases against said shoulder to prevent said arm from downward movement and said boss biases against said groove or recess to prevent said arm from further upward movement so that said arm is locked into said predetermined position relative to said base.

5. Apparatus of claim 1, wherein said second end of said arm is hingedly connected to two uprights at the distal portion of said base;

wherein said first lock mechanism comprises;

two fingers extending sideways from said arm proximate to its second end, each of said fingers having at least two stop surfaces;

wherein said second lock mechanism comprises;

a pair of upright guides each extending from said base to face a corresponding one of said uprights, each guide having a notch to which a corresponding one of the fingers from said arm rests when said arm lies horizontally over said base, each guide having a guide surface along which the corresponding one finger of said arm moves when said arm is pivoted upwards away from said base and a stop surface that coacts against one of the stop surfaces of the corresponding one finger when the pivotal movement of said arm positions the tip of said cannula within said bore to thereby prevent said arm from moving in a downward direction; and

a recess formed on each front edge of said uprights, said recess coacts against other of the stop surfaces of the corresponding one finger when the pivotal movement of said arm positions the tip of said cannula within said bore to thereby prevent said arm from further upward movement relative to said base.

6. Apparatus of claim 1, further comprising a dam at the proximal portion forward of said one opening and said bore, said dam providing a stop for the first end of said arm for enabling a user to push said cannula into a patient by pressing on said arm.

7. Apparatus of claim 1, wherein said cannula comprises a vertical portion extending downwardly from the first end of said arm and a horizontal portion mounted along the length of said arm, the tip and a substantial portion of said vertical portion extending beyond said opening of said base prior to use.

8. Apparatus of claim 1, further comprising a tube connected to the horizontal portion of said cannula at the second end of said arm for establishing a fluid path whereby fluid is passable between said tube and the tip of said cannula.

9. Apparatus of claim 1, wherein the lower surface of said base is substantially flat to enable said base to lie substantially planarly along the skin of a patient, and wherein said bore extends from said other opening substantially flush with the flat lower surface to said one opening at the upper surface of said base.

10. Apparatus of claim 1, wherein the proximal portion of said base is dome shaped to enable said base to fittingly cover an infuser.

11. A safety needle device, comprising:

a base having a distal portion and a proximal portion, one opening at an upper surface of said base and an other opening at a lower surface of said base provided at the proximal portion of said base, a bore defined between said one opening at the upper surface of said base and said other opening at the lower surface of said base;

an arm having a first end and a second end, the second end of said arm being hingedly connected to the distal portion of said base so that said arm is pivotally movable relative to said base at its second end; and

a cannula having a tip extending downwardly from the first end of said arm and passes through said one and other openings of said base before use;

wherein when the first end of said arm is moved to its upmost position, said cannula is withdrawn from said other opening and the tip of said cannula is positioned within said bore.

12. Device of claim 11, further comprising:

a first lock mechanism provided at the distal portion of said base; and

a second lock mechanism provided at the second end of said arm;

wherein said first and second lock mechanisms coact to prevent further movement of said arm relative to said base after the tip of said cannula is positioned within said bore.

13. Device of claim 11, wherein said second lock mechanism comprises a leg extending from the second end of said arm and wherein first lock mechanism comprises a shoulder at the distal portion of said base, wherein said leg biases against said shoulder to prevent said arm from downward movement once said arm has been pivoted to a predetermined position whereby the tip of said cannula is positioned within said bore.

14. Device of claim 11, wherein said second lock mechanism comprises a boss extending from the second end of said arm and wherein said first lock mechanism comprises a groove or recess at the distal portion of said base, wherein said boss is caught in and biases against said groove or recess to prevent said arm from further upward movement once said arm has been pivoted to a predetermined position whereby the tip of said cannula is positioned within said bore.

15. Device of claim 11, wherein said second lock mechanism comprises a leg extending from one side of said arm and a boss extending from another side of said arm, and said first lock mechanism comprises a shoulder at one side of the distal portion of said base and a groove or recess provided at an upright at another side of the distal portion of said base;

and

wherein when said arm is pivoted upwards relative to said base to a predetermined position whereby the tip of said cannula is positioned within said bore, said leg biases against said shoulder to prevent said arm from further downward movement and said boss biases against said groove or recess to prevent said arm from further upward movement so that said arm is locked into said predetermined position relative to said base.

16. Apparatus of claim 11, wherein said second end of said arm is hingedly connected to two uprights at the distal portion of said base;

wherein said first lock mechanism comprises;

two fingers extending sideways from said arm proximate to its second end, each of said fingers having at least two stop surfaces;

wherein said second lock mechanism comprises;

a pair of upright guides each extending from said base to face a corresponding one of said uprights, each guide having a notch to which a corresponding one of the fingers from said arm rests when said arm lies horizontally over said base, each guide having a guide surface along which the corresponding one finger of said arm moves when said arm is pivoted upwards away from said base and a stop surface that coacts against one of the stop surfaces of the corresponding one finger when the pivotal movement of said arm positions the tip of said cannula within said bore to thereby prevent said arm from moving in a downward direction; and

a recess formed on each front edge of said uprights, said recess coacts against other of the stop surfaces of the corresponding one finger when the pivotal movement of said arm positions the tip of said cannula within said bore to thereby prevent said arm from further upward movement relative to said base.

17. Device of claim 11, wherein said cannula comprises a right angle cannula having a horizontal portion mounted to said arm and a vertical portion having the tip that is positionable within said bore.

18. Device of claim 17, further comprising a tube connected to the horizontal portion of said cannula at the second end of said arm for establishing a fluid path whereby fluid is passable between said tube and the tip of said cannula.

19. Device of claim 11, wherein the lower surface of said base is substantially flat to enable said base to lie in substantially planarly along the skin of a patient, and wherein said bore extends from said other opening substantially flush with the flat lower surface to said one opening at the upper surface of said base.

20. Device of claim 11, wherein the proximal portion of said base is dome shaped to enable said base to fittingly cover an infuser.

21. A safety needle device, comprising:

a base having a distal portion and a proximal portion, one opening at an upper surface of said base and an other opening at a lower surface of said base provided at the proximal portion of said base, a bore defined between said one opening at the upper surface of said base and said other opening at the lower surface of said base;

an arm having a first end and a second end, the second end of said arm being hingedly connected to the distal portion of said base so that said arm is pivotally movable relative to said base at its second end;

a right angle cannula mounted to said arm, a vertical portion of said cannula including the tip of said cannula extending downwardly from the first end of said arm and passes through said one and other openings of said base before use, a horizontal portion of said cannula mounted along the length of said arm;

a first lock mechanism having a first and a second part provided at the distal portion of said base; and

a second lock mechanism having a first and second part provided at the second end of said arm;

wherein the respective first parts of said first and second lock mechanisms coact to prevent further movement of said arm relative to said base along one direction after the tip of said cannula is positioned within said bore, and

wherein the respective second parts of said first and second lock mechanisms coact to prevent further movement of said arm relative to said base along another direction once the tip of said cannula is positioned within said bore.

22. Device of claim 21, further comprising a tube connected to the horizontal portion of said cannula at the second end of said arm for establishing a fluid path whereby fluid is passable between said tube and the tip of said cannula.

23. Device of claim 21, wherein said the lower surface of said base is substantially flat to enable said base to lie substantially planarly along the skin of a patient, and wherein said bore extends from said other opening substantially flush with the flat lower surface to said one opening at the upper surface of said base.

24. Device of claim 21, wherein said first part and said second part of said first lock mechanism comprise a shoulder and a groove or recess, respectively, and wherein said first part and said second part of said second lock mechanism comprises a leg and a boss, respectively;

and

wherein said shoulder and said leg coact to prevent downward movement and said boss and said groove or recess coact to prevent further upward movement of said arm relative to said base when the tip of said cannula is positioned within said bore in said base.