Stabilized elongate implantable vascular access device

• US 8,083,723 B2
• Filed: 04/07/2008
• Issued: 12/27/2011
• Est. Priority Date: 04/05/2007
• Status: Expired due to Fees

• Current Assignee: Stealth Therapeutics, Inc.
• Original Assignee: Stealth Therapeutics, Inc.
• Inventors: Glenn, Bradley J.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Scott, Brandy C
• Application Number:
  US12/080,981
• Publication Number:
  US 20080249509A1
• Time in Patent Office: 1,359 Days
• Field of Search: 604/105, 604/106, 604/175, 60428801-28804
• US Class Current: 604/288.01
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0232 having means for facilitating the insertion into the body
• 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 vascular access port is described that is elongate in form. A distal end is coupled to a tube which leads into a body lumen. A proximal end has a head thereon with a septum which can be repeatedly penetrated by a needle and reseal, for repeated administration of medications or other compositions through the port and into the body of the patient. A wing is attached to the body that has two positions including a streamlined first position for implantation and a wider second position for stabilization of the port after implantation. A stay is preferably also provided to abut the wing when in the second position to keep the wing in the second position when fully deployed.

Claims

1. A subcutaneous port for providing access to a body lumen, the port comprising in combination:

an elongate body having a hollow interior extending between ends thereof;

a head adjacent one of said ends of said body;

said head including a chamber communicating with said hollow interior of said elongate body;

a septum coupled to and in contact with said head and adjacent said chamber, said septum adapted to be penetrated by a needle passing through the skin;

said elongate body adapted to be coupled, at least indirectly, to a body, lumen; and

a rigid wing affixed to and in contact with said elongate body and movably coupled to said elongate body, said wing having at least one tip, said tip having at least two positions including a first position and a second position relative to said body, said first position closer to said body than said second position.

2. The port of claim 1 wherein said elongate body includes an outlet end opposite said head, said outlet end adapted to be coupled, at least indirectly, to the body lumen.

3. The port of claim 1 wherein said wing has an elongate form of constant length and is located at an intermediate position between said ends of said elongate body.

4. The port of claim 3 wherein said wing is located closer to a middle of said elongate body than to either of said ends of said body.

5. The port of claim 3 wherein said wing is located on an underside of said elongate body adapted to be oriented most distant from skin beneath which the port is adapted to be implanted.

6. The port of claim 1 wherein said at least one wing is streamlined such that it passes mom easily into a subcutaneous space than being pulled out of the subcutaneous space.

7. The port of claim 1 wherein said wing is adapted to rotate between said first position and said second position and a stay is adapted to be interposed against said wing to hold said wing in said second position.

8. The port of claim 7 wherein said stay includes a snap stay adapted to snap onto said elongate body and surrounding at least a portion of said elongate body adjacent said wing with said snap stay including at least one downwardly extending finger adapted to abut a portion of the wing which resists the wing from rotating from said second position to said first position.

21. The port of claim 1 wherein said rigid wing is adapted to pivot relative to said elongate body, between said first position and said second position.

22. The port of claim 21 wherein said wing is adapted to pivot about an axis non-parallel with a length of said elongate body.

23. The port of claim 22 wherein said wing is adapted to pivot about an axis substantially perpendicular to said length of said elongate body.

9. A method for reliably and repeatedly accessing a body lumen through a subcutaneous port, the method including the steps of:

providing a port having an elongate body having a hollow interior extending between ends thereof, a head adjacent one of the ends of the body, the head including a chamber communicating with the hollow interior of the elongate body, a septum coupled to and in contact with the head and adjacent the chamber, the septum adapted to be penetrated by a needle passing through the skin, the elongate body adapted to be coupled, at least indirectly, to a body lumen, and a rigid wing affixed to and in contact with the elongate body and movably coupled to the elongate body, the wing having at least one tip, the tip having at least two positions including a first position and a second position relative to the body, the first position closer to the body than the second position;

forming an incision adjacent where the port is desired to be implanted;

inserting the port into the desired position subcutaneously; and

coupling a portion of the body at least indirectly to the body lumen to be accessed.

10. The method of claim 9 including the further step of rotating the rigid wing by a pivoting motion from the first position to the second position.

11. The method of claim 10 including the further step of manipulating a stay to abut the wing and resist rotation of the wing from the second position to the first position.

24. The method of claim 10 wherein said rotating step includes pivoting the wing about an axis non-parallel with a length of the elongate body.

12. A method for reliably and repeatedly accessing a body lumen through a subcutaneous port, the method including the steps of:

providing a port having an elongate body having a hollow interior extending between ends thereof, a head adjacent one of the ends of the body, the head including a chamber communicating with the hollow interior of the elongate body, a septum coupled to the head and adjacent the chamber, the septum adapted to be penetrated by a needle passing through the skin, the elongate body adapted to be coupled, at least indirectly, to a body lumen, and a rigid wing affixed to the elongate body and movably coupled to the elongate body, the wing having at least one tip, the tip having at least two positions including a first position and a second position relative to the body, the first position closer to the body than the second position;

forming an incision adjacent where the port is desired to be implanted;

inserting the port into the desired position subcutaneously; and

coupling a portion of the body at least indirectly to tie body lumen to be accessed, rotating the rigid wing by a pivoting motion from the first position to the second position;

pushing on a portion of the elongate body on a side of the wing opposite the head through the skin to cause portions of the elongate body on a side of the wing opposite where pushing is occurring to be moved toward the skin; and

passing a needle through the skin and into the septum within the head of the elongate body after the head has been raised for easy access by said pushing step.

13. A subcutaneous body lumen access port, comprising in combination:

an elongate body extending between a distal end and a proximal end;

said elongate body including a hollow interior pathway extending substantially from said distal end to said proximal end;

said elongate body having a length from said distal end to said proximal end and a width lateral to said length, said width less than said length;

said proximal end including a septum adjacent thereto;

said septum adapted to be penetrated by a needle to facilitate transfer of fluids between said hollow interior and the needle;

said distal end adapted to be coupled to a body lumen in a manner facilitating transfer of fluids between said hollow interior pathway of said elongate body and the body lumen; and

wherein a rigid wing is affixed to said elongate body and interposed between said proximal end and said distal end, said wing adapted to move from a first position to a second position with said elongate body having a narrower cross-section when said wing is in said first position than said second position and said wing having a greater cross-section than said proximal end when said wing is in said second position.

14. The port of claim 13 wherein said septum is rigidly coupled to said elongate body, said septum having an access surface at which the needle is adapted to pass into said septum, said access surface oriented substantially perpendicular to a longitudinal axis of said elongate body extending from said proximal end to said distal end.

15. The port of claim 13 wherein a length of said elongate body between said proximal end and said distal end is at least five times greater than said width of said elongate body.

16. The port of claim 13 wherein a stay is movably locatable adjacent said wing to resist movement of said wing from said second position to said first position.

17. The port of claim 13 wherein said rigid wing is elongate with a constant length and is rotatably coupled to said elongate body.

18. The port of claim 13 wherein said septum is located within a head adjacent said proximal end of said elongate body, said head having a width greater than said width of other portions of said elongate body, such that palpation of said port when said port is implanted subcutaneously allows a medical practitioner to discern where said head is located relative to other portions of said port.

19. The port of claim 18 wherein said head is angled up from a longitudinal axis of said elongate body extending from said proximal end to said distal end, with said septum adapted to be accessed substantially axially at said head.

20. The port of claim 13 wherein a tube is coupled to said distal end, said tube having a flexible elongate form with an interior of said tube in fluid communication with said hollow interior pathway of said elongate body, said tube adapted to extend from said distal end of said elongate body to an interior of the body lumen for transfer of fluids between said hollow interior of said elongate body and the body lumen.