Portal access device with removable sharps protection

• US 20070149920A1
• Filed: 12/28/2005
• Published: 06/28/2007
• 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: Beling, William, Travis, Ronald, Michels, Lester
• Granted Patent: US 7,549,976 B2
• Time in Patent Office: Days
• US Class Current: 604/93.10
• 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 to which 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 an opening at a proximal portion of said base, the proximal portion of said base configured to fit over 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.

2. Combination of claim 1, wherein said base comprises a body having a bore extending from said opening at its proximal portion through which said sharp cannula passes, 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 said infuser comprises a housing having an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal said housing, 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 proximal portion of said base comprises a dome that covers 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, said port pierceable by said sharp cannula to position at least a portion of said blunt cannula in said port, the portion of said blunt cannula remaining inside said port after the removal of said sharp cannula from said blunt cannula so that a fluid path is established between said port and said tube through said infuser.

14. Apparatus of claim 1, wherein the proximal portion of said base comprises a dome that covers said infuser when said sharp cannula is mated to said blunt cannula.

9. Apparatus comprising:

an infuser having 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 distal portion and a proximal portion, 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, an opening provided at the proximal portion of said base, said base covering said infuser with said sharp cannula removably mated to said blunt cannula through said opening 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.

10. Apparatus of claim 9, wherein said base comprises a body having a bore extending from said opening at its proximal portion through which said sharp cannula passes, said arm being 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.

11. Apparatus of claim 9, 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.

12. Apparatus of claim 9, 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.

13. Apparatus of claim 9, wherein said infuser comprises a housing having an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal said housing, 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 for establishing fluid communication to a port implanted to a patient, comprising:

an infuser having 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, said base superposed over said infuser, 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.

16. Apparatus of claim 15, wherein said base comprises a body having a distal portion and a proximal 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, an opening provided at the proximal portion of said base through which said sharp cannula is removably mated to said blunt cannula, the proximal portion of said base being configured to cover said infuser, a bore extending from said opening at the proximal portion of said body, said sharp cannula being removed from said blunt cannula when said arm is pivoted at its second end to raise the second end of said arm away from said body, the tip of said sharp cannula being positioned within said bore once said sharp cannula is removed from said infuser.

17. Apparatus of claim 15, 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.

18. Apparatus of claim 15, wherein said infuser comprises a housing having an aperture at its top in longitudinal alignment with said blunt cannula, a septum at said aperture to seal said housing, 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.

19. 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 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;

c) superposing said base over 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.

20. Method of claim 19, wherein said base comprises a body having a distal portion and a proximal 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;

providing an opening at the proximal portion of said body through which said sharp cannula is removably mated to said blunt cannula; and

providing a bore extending from said opening at the proximal portion of said body.

21. Method of claim 20, 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.

22. Method of claim 21, 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.

23. Method of claim 19, wherein said infuser comprises a housing, the method further comprising the steps of:

providing an aperture on the top of said housing 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 said housing after said sharp cannula is removed from said infuser.

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

configuring the proximal portion of said base to cover said housing; and

configuring the distal portion of said base to cover said tube.

25. Apparatus comprising an infuser housing adaptable for storing fluids, a blunt cannula extending downwardly from said housing adapted to be inserted into a port, and a tube connected to a side of said housing, a fluid path being established between said tube and said blunt cannula through said housing.

26. Apparatus of claim 25, further comprising a septum provided at the top of said housing in axial alignment with said blunt cannula, said septum adaptable to enable a sharp cannula to be inserted therethrough to mate axially within said blunt cannula, with the tip of said sharp cannula protruding from the tip of said blunt cannula, said septum self sealing once said sharp cannula is removed therefrom to maintain the fluid path between said blunt cannula and said tubing as closed fluid path.