Portal access device with removable sharps protection

• US 7,549,976 B2
• Filed: 12/28/2005
• Issued: 06/23/2009
• 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
• Inventors: Michels, Lester D., Travis, Ronald G., Beling, William L.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/318,484
• Publication Number:
  US 20070149920A1
• Time in Patent Office: 1,273 Days
• Field of Search: 604/93.01, 604/110, 604/233, 604/239
• 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. In combination, a blunt cannula, an infuser having a body of a given shape to which lower surface said blunt cannula is connected, a tube extending from said infuser, said infuser establishing a fluid communication path between said blunt cannula and said tube, a sharp cannula removably mated to said blunt cannula through said infuser with the tip of said sharp cannula exposed beyond the tip of said blunt cannula, said sharp cannula attached to a first end of an arm, a second end of said arm movably connected to a distal portion of a base, said sharp cannula extending through a bore defined by an opening at an upper surface and an other opening at a lower surface at a proximal portion of said base, the proximal portion of said base configured to have a shape that form fits over the given shape of the body of said infuser when said sharp cannula is mated to said blunt cannula, said sharp cannula removed from said blunt cannula when the first end of said arm is moved in a direction away from the proximal portion of said base, said base removable from said infuser when said sharp cannula is removed from said blunt cannula and said arm is locked in place relative to said base as the first end of said arm is moved in the direction away from the proximal portion of said base.

2. Combination of claim 1, wherein after the first end of said arm is fully moved to its upmost position, the tip of said sharp cannula is positioned within said bore.

3. Combination of claim 1, wherein said base comprises at its distal portion one part of a lock mechanism and wherein said arm comprises at its second end an other part of said lock mechanism, said one and other parts coacting to prevent further movement of said arm relative to said base after the first end of said arm has been moved to its upmost position relative to said base to thereby fixedly maintain the tip of said sharp cannula within said bore.

4. Combination of claim 1, further comprising a septum provide on said infuser through which said sharp cannula passes when said sharp cannula is mated to said blunt cannula, said septum sealing said infuser when said sharp cannula is removed from said infuser.

5. Combination of claim 1, wherein the body of said infuser comprises an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal the body of said infuser, wherein said sharp cannula mates to said blunt cannula through said septumed aperture, and wherein said infuser has a lower surface adapted to lie substantially flat against the skin of a patient where the blunt cannula is inserted to the patient.

6. Combination of claim 1, wherein the body of said infuser is dome shaped, and wherein the proximal portion of said base comprises a dome that form fittedly covers the body of said infuser when said sharp cannula is mated to said blunt cannula.

7. Combination of claim 5, further comprising at least one wing provided at said infuser to enable a user to maintain said infuser against the skin of the patient as said sharp cannula is removed from said blunt cannula or when said base is separated from said infuser.

8. Combination of claim 1, further comprising a port implanted in the patient, wherein said port is pierced by said sharp cannula to position at least a portion of said blunt cannula in said port when the combination of blunt cannula and sharp cannula is inserted into the patient, the portion of said blunt cannula inserted in said port remaining inside said port after the removal of said sharp cannula from said blunt cannula and the removal of said base from said infuser, said infuser remaining on the patient so that a fluid path is established between said port and said tube through said infuser.

9. Combination of claim 1, wherein the proximal portion of said base comprises a window to enable a user to confirm that the proximal portion is appropriately form fitted over the body of said infuser.

10. Apparatus comprising:

an infuser having a body of a given shape, a blunt cannula extending downwardly from a lower surface of the body and a tube connected to the body for establishing a fluid communication path between said tube and said blunt cannula;

a base having a distal portion and a proximal portion configured to have a shape to form fit over the given shape of the body of said infuser, an arm having a second end hingedly and movably connected to the distal portion of said base, a sharp cannula attached to a first end of said arm, a bore defined between an opening at an upper surface and an other opening at a lower surface at the proximal portion of said base, the proximal portion of said base form fitting over the body of said infuser when said sharp cannula is removably mated to said blunt cannula through said bore at the proximal portion of said base and the tip of said sharp cannula exposed beyond the tip of said blunt cannula when said arm lies substantially longitudinally along said base;

wherein said sharp cannula is removed from said blunt cannula when said first end of said arm is moved pivotally in a direction away from said base.

11. Apparatus of claim 10, wherein said arm is pivoted at its second end to remove said sharp cannula from said blunt cannula, the tip of said sharp cannula being positioned within said bore after said sharp cannula is removed from said blunt cannula and said infuser, said base being separable from said infuser after said sharp cannula is removed from said infuser.

12. Apparatus of claim 10, wherein said base comprises at its distal portion one part of a lock mechanism and wherein said arm comprises at its second end an other part of said lock mechanism, said one and other parts coacting to prevent further movement of said arm relative to said base after said sharp cannula has been removed from said infuser.

13. Apparatus of claim 10, further comprising a septum provide on the body of said infuser through which said sharp cannula passes when said sharp cannula is mated to said blunt cannula, said septum sealing the body of said infuser when said sharp cannula is removed from said infuser.

14. Apparatus of claim 10, wherein the body of said infuser comprises an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal said body, wherein said sharp cannula mates to said blunt cannula through said septumed aperture, and wherein said infuser has a lower surface adapted to lie substantially flat against the skin of a patient where the blunt cannula is inserted to the patient.

15. Apparatus of claim 10, wherein the body of said infuser is dome shaped and wherein the proximal portion of said base comprises a dome that form fittedly covers said infuser when said sharp cannula is mated to said blunt cannula, said dome shaped proximal portion including a window to enable a user to view the body of said infuser.

16. Apparatus for establishing fluid communication to a port implanted to a patient, comprising:

an infuser having a body of a given shape with a blunt cannula extending downwardly therefrom and a tube connected thereto for establishing a fluid communication path between said tube and said blunt cannula;

a base having a sharp cannula, a proximal portion of said base configured to have a shape that form fits over the body of said infuser and a remainder portion configured to fit over said tube, said sharp cannula removably mated to said blunt cannula with the tip of said sharp cannula exposed beyond the tip of said blunt cannula;

wherein said sharp cannula is removed from said blunt cannula after the combined sharp and blunt cannulas were inserted to the patient to position said cannulas in said port, said blunt cannula remaining positioned in said port to establish a fluid communication path from said infuser to said port via said blunt cannula.

17. Apparatus of claim 16, wherein said base further comprises a distal portion, an arm having a second end hingedly connected to the distal portion of said base, said sharp cannula attached to a first end of said arm, a bore provided at the proximal portion of said base through which said sharp cannula is removably mated to said blunt cannula when the proximal portion is form fitted over the body of said infuser, said bore defined between and extending from an opening at an upper surface and an other opening at a lower surface at the proximal portion of said base, said sharp cannula being removed from said blunt cannula when said arm is pivoted to raise its second end away from the body of said infuser, the tip of said sharp cannula being positioned within said bore once said sharp cannula is removed from said infuser.

18. Apparatus of claim 16, wherein said base comprises at its distal portion one part of a lock mechanism and wherein said arm comprises at its second end an other part of said lock mechanism, said one and other parts coacting to prevent further movement of said arm relative to said base after the tip of said sharp cannula has been removed from said infuser.

19. Apparatus of claim 16, wherein the body of said infuser comprises an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal said infuser, wherein said sharp cannula mates to said blunt cannula through said aperture, said septum sealing said infuser after said sharp cannula is removed from said infuser.

20. Apparatus of claim 16, wherein the proximal portion of said base comprises a window to enable a user to confirm that the proximal portion is appropriately form fitted over the body of said infuser.

21. A method of establishing a fluid path between a fluid store and a port implanted in a patient, comprising the steps of:

a) providing an infuser having a body of a given shape and a blunt cannula extending downwardly therefrom and a tube having one end connected thereto and another end connected to said fluid store, said tube being in fluid communication with said blunt cannula;

b) providing a base having a sharp cannula, and a proximal portion configured to have a shape form fittable over the body of said infuser and a remainder portion configured to fit over said tube;

c) form fitting the proximal portion of said base over the body of said infuser and removably mating said sharp cannula to said blunt cannula until the tip of said sharp cannula is exposed beyond the tip of said blunt cannula;

d) inserting the combined sharp and blunt cannulas to the patient to position said cannulas into said port; and

e) removing said sharp cannula from said blunt cannula while leaving said blunt cannula in said port;

whereby a fluid communication path is established between said port and said fluid store through said blunt cannula and said infuser.

22. Method of claim 21, wherein said base further comprises a distal portion, said step b further comprising the steps of:

hingedly connecting a second end of an arm to the distal portion of said base;

attaching said sharp cannula to a first end of said arm; and

providing a bore at the proximal portion of said body through which said sharp cannula is removably mated to said blunt cannula, said bore defined between an opening at an upper surface and an other opening at a lower surface of the proximal portion of said base.

23. Method of claim 22, wherein said step e further comprises the step of:

maintaining the tip of said sharp cannula within said bore once said sharp cannula is removed from said infuser.

24. Method of claim 23, further comprising the step of:

providing respective coacting parts of a locking mechanism at the distal portion of said body and the second end of said arm to prevent said arm and said body from further movement relative to each other once the tip of said cannula is positioned within said bore.

25. Method of claim 21, further comprising the steps of:

providing an aperture on the top of the body of said infuser in longitudinal alignment with said blunt cannula, said sharp cannula mating to said blunt cannula through said aperture;

adding a septum to said aperture to seal the body of said infuser after said sharp cannula is removed from said infuser.

26. Method of claim 21, further comprising the step of:

forming a window at the proximal portion of said base to enable a user to confirm that the proximal portion is appropriately form fitted over the body of said infuser.