Subcutaneous venous access device and needle system

• US 4,861,341 A
• Filed: 07/18/1988
• Issued: 08/29/1989
• Est. Priority Date: 07/18/1988
• Status: Expired due to Term

• Current Assignee: Robert T. Woodburn
• Original Assignee: Robert T. Woodburn
• Inventors: Woodburn, Robert T.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/220,609
• Time in Patent Office: 407 Days
• Field of Search: 604/93, 604/96, 604/104, 604/239, 604/272-274, 604/244, 604/239, 604/174, 604/175, 604/411, 604/412
• US Class Current: 604/175
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft

Abstract

A system of a subcutaneous venous access device or injection port and needle, wherein the port includes a self-closing septum for repeatedly and periodically receiving a predetermined section of an injection needle, and which septum covers an injection-receiving chamber in communication with a vein. The needle has a non-coring (e.g., "Huber" or removable stylet) point and means for providing a locking configuration such as increased diameter but smooth outer surface of the needle port-received section, which, when properly inserted, is within the septum or chamber, so as to more securely affix the needle within the port and prevent or decrease the incidence of accidental partial or total removal and the resulting undesirable subcutaneous infiltration of chemicals during infusion. The locking configuration means is, in one embodiment, an expansion section which is maintained (and returned) to a non-expanded configuration by use of a needle core or stylet and which section automatically expands upon removal of the stylet. A second embodiment employs a balloon segment of the needle which is manually inflated in the chamber after setting of the needle in the port. A third and fourth embodiment provide permanent, multi-ridged surfaces which cooperate with the septum to secure the needle in its proper position.

Claims

1. In a subcutaneous venous access system of

a port device defining a chamber with a septum for allowing a needle input into the chamber and a catheter output from the chamber:

a needle assembly having a shaft section and a point, means for allowing the non-coring entry of the needle point through skin and the septum and which, when seated in the chamber, has a shaft segment which extends through the septum and into the chamber; and

means for providing a changed outside diameter portion of the outside surface of the shaft in said segment;

whereby said needle assembly may be seated into the chamber of the port device and said changed diameter section serve to prevent or reduce the possibility of said needle being unintentionally removed from the chamber and septum during use.

2. The system of claim 1, wherein said changed diameter is achieved by an increasing diameter wall portion in said shaft segment of said needle.

3. The system of claim 2, wherein said increased-diameter wall portion is achieved with a smooth, streamlined outer surface transition above and below said portion and the outside diameter of the shafts varies from a minimum to a maximum which, is at least maximum approximately twice the minimum diameter.

4. The system of claim 2, wherein said increased diameter section is created by a ballooning outward of the outer wall portion.

5. The system of claim 4, wherein said ballooning is selectably achieved by providing an elastic outer wall segment of said shaft at said portion, means defining a secondary fluid path through the needle shaft between said portion and a location remote from the needle point, and means for providing a second fluid pressure input into said secondary path at said remote location.

6. The system of claim 5, wherein said secondary pressure input includes a second septum, and the pressure may be increased or decreased to balloon out or retract said elastic wall segment by injecting a fluid through a removable needle into said second septum.

7. The system of claim 2, wherein said increased diameter section is reversably formed by spring action.

8. The system of claim 7, wherein said needle apparatus includes a central stylet which is sized and shaped to pass through the needle shaft and which when fully inserted causes the increased diameter section to reduce its diameter and when removed permits it to spring outward to increase its diameter.

9. The system of claim 1, wherein a plurality of successive changed diameter outer surface portions are formed along the length of the shaft in said section, to form a row of ridges which are gripped by said septum when the needle is properly seated in said port.

10. The system of claim 9 wherein the diameter of the ridges is at least approximately twice the minimum diameter between the ridges.

11. A needle apparatus for use with a subcutaneous venous access device of a type having a needle entry septum of a predetermined thickness and a chamber thereunder of a set depth under the septum, comprising:

a needle shaft defining a fluid passageway to a needle point, said shaft having a section from the point rearward of a length equal to this set depth and the predetermined thickness, said shaft having an approximately constant diameter over the majority of its length;

a non-coring needle point formed at the end of said shaft; and

means for providing a different outside surface configuration of said shaft at said section for aiding in releasably securing the needle apparatus in said device when said needle point is driven into and through said septum and into said chamber for a distance.

12. The needle apparatus of claim 11, wherein said means for providing a different outside configuration provides a series of successive ridges along at least a portion of the length of said section.

13. The needle apparatus of claim 11, wherein said means for providing a change in the outside configuration provides an expanded bulge therein near the point, which bulge is located under the septum when the needle has passed through it and entered the chamber.

14. The needle apparatus of claim 13, wherein said means includes means for selectively forming and retracting said bulge.

15. The needle apparatus of claim 14, wherein said selectable forming and retracting means is a stylet which is sized to be inserted into said shaft and when so inserted also provides the non-coring feature of the point.

16. The needle apparatus of claim 15, wherein said stylet has a conical point and said needle point has a decreased diameter which mates with said conical point, whereby the stylet when pressed downward to the point presses against the needle point and axially stresses the needle shaft, and the section includes a flexible wall section which forms said bulge when not axially stressed, but which when axially stressed tends to retract, whereby placing and pressing the stylet into the shaft substantially retracts the bulge for insertion and retraction, but removal of the stylet allows the bulge to form.