Subcutaneous access needle and method

• US 6,544,214 B1
• Filed: 05/25/1999
• Issued: 04/08/2003
• Est. Priority Date: 05/25/1999
• Status: Expired due to Fees

• Current Assignee: DSU Medical Corporation
• Original Assignee: DSU Medical Corporation
• Inventors: Utterberg, David S.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/318,419
• Time in Patent Office: 1,414 Days
• Field of Search: 604/93.01, 604/272, 604/264, 604/244, 604/265, 604/183, 604/242, 604/175, 604/164.01, 604/164.04, 604/164.1, 604/164.11, 604/164.12, 604/164.13
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2039/009 Means for limiting access to the septum, e.g. shields, grids
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A cannula is provided for connection with an implanted artificial port through a preformed needle track through the skin of a patient. The port has a flow conduit to connection with the body lumen and the closure member for blocking flow between the port and the body lumen. The closure member is normally closed, but openable by an insertion of a properly sized cannula into the port. The first cannula has a proximal end which is connected to a hub, a proximal portion adjacent to the proximal end, and a distal portion. The distal portion is of insufficient size to open the closure member when inserted into the port, so that the first cannula may be used for flushing the implanted port interior and the needle track with disinfectant solution. The proximal portion is of larger diameter than the distal portion and is proportioned to dilate the needle track to facilitate subsequent advancement of a larger diameter fluid flow cannula through the needle track after withdrawing of the first cannula. The larger, fluid flow cannula is of a size sufficient to open the closure member to obtain communication with the body lumen.

Claims

1. A combination cannula and artificial port comprising:

an implantable artificial port having a flow conduit for connection with a body lumen and a closure member for blocking flow between the port and the body lumen, said closure member being normally closed but openable by insertion of a properly sized and shaped cannula into said port; and

a first, substantially rigid predilation and disinfecting cannula for connection with the implantable artificial port through the skin of a patient, said first cannula having a proximal end, a proximal portion adjacent to said proximal end, a distal portion, and a frustoconical transition portion between the proximal and distal portions, said distal portion being of insufficient size to open said closure member when inserted at least partially into the port, said proximal portion being of larger diameter than said distal portion and being proportioned to dilate said needle track to facilitate subsequent advancement of a larger fluid flow cannula through said needle track after withdrawing said first cannula, said first cannula being connected to a source of solution for flushing and disinfecting of said needle track.

2. The cannula of claim 1 in which said first cannula is at least 15 mm. in length.

3. The cannula of claim 2 in which said proximal portion for the first cannula has an outer diameter of about 1.2 to 2.7 mm. and said distal portion has an outer diameter of about 0.5 to 1.5 mm.

4. The cannula of claim 1 in which said distal cannula portion has a blunt end.

5. The cannula of claim 1 in which said first cannula is connected to a source of disinfectant solution capable of use for flushing of said needle track.

6. The cannula of claim 1 in which said proximal and distal-portions are cylindrical.

7. A medical procedure kit which comprises:

a first cannula set having a first, substantially rigid, predilation, disinfecting cannula for connection with an implantable artificial port through a preformed needle track through the skin of a patient, said first cannula having a proximal portion and a distal portion, said proximal portion being of larger diameter than said distal portion and being proportioned to dilate said needle track to facilitate subsequent advancement of a larger diameter blood flow cannula through said needle track after withdrawing said first cannula, said first cannula further defining a frustoconical transition portion between said proximal and distal portions and the distal portion having a diameter less than a diameter of a bore of the artificial port so that a gap is formed between a side of the cannula and the bore of the artificial port providing for disinfectant fluid to be passed through the cannula, into the artificial port, through the gap and through the tissue track so that the first cannula provides a dual function of dilating and flushing the needle track;

a second cannula set which comprises a second blood flow cannula for providing access through the skin of a patient through said needle track, the proximal portion of said first cannula having a minimum outer diameter that is about seventy to one hundred twenty five percent of a minimal outer diameter of said second cannula; and

packaging for both of said cannula sets.

8. The kit of claim 7 in which said second cannula comprises a proximal end connected to a second hub and a distal end, said second cannula tapering inwardly from the proximal to the distal end.

9. The kit of claim 8 in which said proximal and distal portions are cylindrical and the distal cannula end being blunt.

10. The kit of claim 9 in which said first cannula is connected to a length of tubing, said tubing being also connected to a source of solution capable of use for flushing of a needle track extending through the skin and outer tissue of a patient.

11. The kit of claim 10 in which the minimum outer diameter of the first cannula proximal portion is at least twice the minimum outer diameter of the first cannula distal portion.

12. A cannula for providing predilation and disinfection fluid flow access through the skin of a patient, the cannula comprising:

a first, substantially rigid cannula having a proximal end, said cannula having a proximal portion adjacent to said proximal end, said proximal portion having an outer diameter of about 1.2 to 2.7 mm, said cannula having a distal portion adjacent to a cannula distal end, said distal portion having an outer diameter of about 0.5 to 1.5 mm, a maximum outer diameter of the distal portion being smaller than a minimum outer diameter of the proximal portion and smaller than an inner diameter of a pre-formed bore receiving the cannula so that a gap is formed between the distal portion outer diameter and the bore, said cannula further defining a frustoconical transition portion between said proximal and distal portions, said cannula providing for dilation and flushing of a needle track within a patient'"'"'s skin and the cannula being connected to a source of disinfecting solution flowing through the cannula, into the patient, through the gap and into the needle track while the cannula resides therein.

13. The cannula of claim 12 in which said proximal and distal portions are cylindrical.

14. The cannula of claim 12 in which said distal cannula end is blunt.

15. The cannula of claim 12 in which said hub is connected to a length of tubing or a syringe, said tubing or syringe containing disinfectant solution capable of use for flushing of said needle track extending through the skin and outer tissue of a patient.

16. The cannula of claim 12 in which the minimum outer diameter of the first cannula proximal portion is at least twice the minimum outer diameter of the first cannula distal portion.

17. A medical procedure kit which comprises:

the cannula of claim 12;

a second cannula set which comprises a second cannula for providing access through the skin of a patient, the proximal portion of said first cannula having a minimum outer diameter that is about seventy to one hundred percent of a minimum outer diameter of said second cannula; and

packaging for both of said cannulas.

18. The kit of claim 17 in which said second cannula comprises a proximal end connected to a second hub and having a distal end, said second cannula tapering inwardly from the proximal to the distal end.

19. The method of providing access through the skin of a patient for flow communication with a body lumen of a patient, which comprises:

advancing a first cannula having a blunt forward end through a preformed needle track through the skin of the patient, without significantly cutting tissue of the patient, while dilating at least most of the needle track with the cannula to a diameter that is about 70 to 125 percent of the minimum outer diameter of a subsequent cannula, said first cannula having a distal portion of less outer diameter than a first cannula proximal portion positioned for dilating said needle track, said distal portion penetrating an implanted artificial port without opening a closure valve that closes flow between the port and the body lumen, and including the step of passing flushing liquid through said first cannula, most of which liquid then passes out of the patient through said needle track;

removing the first cannula; and

advancing the subsequent cannula through the dilated needle track into flow communication with the patient body lumen, said subsequent cannula being advanced into said flow communication by engagement with said implanted, artificial port.

22. The disinfected blood flow circuit system of claim 19 wherein the predilation cannula has an outer diameter that is about 70-125% of the outer diameter of the blood flow cannula.

23. The disinfected blood flow circuit system of claim 19 wherein the predilation cannula includes a portion having a diameter larger than the second diameter.

24. The disinfected blood flow circuit system of claim 19, wherein the predilation cannula is connected to a disinfectant fluid flow source.

25. The disinfected blood flow circuit system of claim 19 wherein the blood flow circuit cannula includes a portion having a fourth diameter less than the first diameter.

26. The disinfected blood flow circuit system of claim 19 wherein the blood flow circuit cannula has a tapered distal end.

20. A method of providing access through the skin of a patient for communicating with a body

lumen of a patient, which comprises:

advancing a first cannula having a blunt forward end through a preformed needle track through the skin of a patient, without significantly cutting tissue of the patient, while dilating at least most of the needle track with the cannula to a diameter that is about 70 to 125 percent of the minimum diameter of a subsequent cannula;

removing the first cannula; and

advancing the subsequent cannula through the dilated needle track into flow communication with the patient body lumen and wherein said first cannula has a distal portion of less outer diameter than a first cannula proximal portion positioned for dilating said needle track, said distal portion penetrating an implanted artificial port without opening a closure valve that separates the port from the body lumen, and including the step of passing flushing liquid through said first cannula, most of said liquid then passing out of the patient through the needle track.

21. A system for providing a disinfected blood flow circuit comprising:

an artificial port having a flow conduit for connection with a body lumen, the flow conduit having a first diameter and a closure member for blocking flow between the port and the body lumen, the closure member openable by a blood-flow circuit cannula having a first diameter at its distal portion sized for opening the closure member and sealing the flow conduit; and

a predilation cannula having at its distal portion a second diameter smaller than the first diameter, the predilation cannula inserted through a needle track into the artificial port wherein the closure member remains closed and the flow conduit remains at least partially open and upon injection of a disinfecting fluid into the predilation cannula the fluid may exit through the flow conduit providing flushing and disinfecting of a needle track while the predilation cannula resides therein.