Device for subcutaneous accessibility

• US 6,013,058 A
• Filed: 06/12/1996
• Issued: 01/11/2000
• Est. Priority Date: 06/12/1996
• Status: Expired due to Fees

• Current Assignee: Biolink Corp. (Acacia Capital Corp.)
• Original Assignee: Biolink Corp. (Acacia Capital Corp.)
• Inventors: Whipple, Dale, Prosl, Frank R.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US08/661,903
• Time in Patent Office: 1,308 Days
• Field of Search: 604/93, 604/174, 604/175, 604/246, 604/283, 604/891.1, 604/167, 604/247, 604/256, 604/169, 604/264, 128/DIG. 26, 128/912, 251/149.1
• US Class Current: 604/167.03
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• 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: Y10S 128/26 Cannula supporters
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

Hemodialysis access and lock device (10) and system, the device comprising an improved lock (32) formed of a resilient plug (34) surrounding an inserted needle cannula (NC) and having radial blades (40) with a tapered outer edge (42) locking to a corresponding tapered surface (44) of a surrounding shell (12) and an internal passage sealed by a duck-bill valve and a strain relief at a catheter and the system comprising one or more of such devices and corresponding hub structures (100) connectable to external fluid conduits and providing control of the needle cannula and an internal obturator (OB) associated with it.

Claims

1. In an access device for subcutaneous access for transfer of fluid into and/or out of a human or animal body and defining an internal passage therein and having a device entrance for access at one end by a cannula passing through the skin and at the other end by an implanted conduit such as a catheter, the improvement therein comprising:

(a) locking structure within the device adjacent the internal passage and any cannula therein and restrained within the device,

(b) means defining a shell structure surrounding the locking structure and having an internal surface adjacent to the locking structure,

(c) means defining at least one essentially rigid blade within the shell spanning the gap between the surface of a cannula inserted in the passage and said internal shell surface, and

(d) said internal shell surface being tapered toward the device entrance so that the beginning of inadvertent cannula withdrawal motion produces an increase in locking force against the at least one blade that in turn restrains cannula axial movement,

the foregoing structure being constructed and arranged so that twisting the cannula pushes each blade from its locking alignment to an unlocking alignment to allow easy cannula withdrawal.

2. Device in accordance with claim 1 wherein three blades are provided.

3. Device in accordance with claim 1 wherein four or more blades are provided.

4. Device in accordance with any of claims 1 or 2 wherein the blades also have an external edge tapering down towards the entrance, corresponding to the taper of said shell internal surface.

5. Device in accordance with claim 1 and further comprising a flexible seal that is held out of the passage when the cannula is inserted and is urged into the passage to block it when the cannula is withdrawn.

6. Device in accordance with claim 5 wherein the flexible seal is in the form of a flexible multiple flap.

7. Device in accordance with claim 6 wherein a small pocket is provided for each flap when pushed aside by the cannula, such pockets being the only regions of the seal for fluid collection when the flaps block the entrance.

8. Device in accordance with claim 7 wherein wire springs are provided to urge the flaps into closing position.

9. Device in accordance with claim 6 wherein there are two flaps to form a duckbill seal.

10. Device in accordance with 6, or 7 wherein cantilever wire springs are provided to urge the flaps into closing position.

11. An access system for transfer of fluid into and/or out of a human or animal body, comprising:

(a) at least one subcutaneously implantable access and lock device with an internal passage, the device being constructed and arranged with an internal body fluid conduit at one end of its internal passage and means to receive a cannula passing through the skin of said body at its other internal passage end and relatively lock the cannula therein or unlock it,

(b) means defining needle assembly with a thin wall sheath or cannula and an internal obturator movable axially therein,

(c) means defining a hub structure for use outside the body for establishing a fluid flow moving between an external conduit and said cannula for providing a passage for controlled positioning of said obturator,

(d) the cannula and obturator being insertable into the access and lock device together and removable separately, whereby the assembled cannula and obturator can be passed through the skin from outside the body to reach the internal passage of the lock device and lock the cannula therein, and wherein the obturator can then be removed, and

means for unlocking and removal of the cannula.

12. The system of claim 11 wherein a connected multiple of lock devices are provided in a form implantable together and in parallel.

13. The system of claim 12 wherein a strain relief for a catheter attached to each device is provided and such strain relief is constructed and arranged to act as a supporting structure for each device, said strain relief including a web enclosure that surrounds the device and the proximal end of said catheter to avoid catheter distortion while allowing said device to pivot under the skin.

14. The system of either of claims 11 or 12 wherein the access and lock device has separate lock and seal elements therein, the lock element being constructed and arranged to control locking/unlocking of the cannula relative to the device by cannula insertion and the seal element constructed and arranged to seal the passage when the cannula is withdrawn.

15. The system of claim 14 wherein the hub structure has a cannula locked into such hub structure so that hub structure rotation results in cannula rotation.

16. The system of either of claims 11 or 12 wherein said hub structure associated with an access and lock device has a cannula locked into such hub structure so that hub structure rotation results in cannula rotation.

17. In an access device for subcutaneous access for transfer of fluid into and/or out of a human or animal body and defining an internal passage therein for access at one end by a cannula passing through the skin and at the other end by an implanted conduit such as a catheter, the improvement therein comprising:

(a) a sealing structure within the device adjacent the internal passage and any cannula therein with a movable portion of the sealing structure in a retracted position when a cannula is in the passage;

(b) the movable portion being constructed and arranged to automatically block the passage as the cannula is withdrawn from the passage wherein the movable portion of the seal structure is flexible and in the form of flexible multiple flaps, said multiple flaps having two flaps to form a duckbill seal,

and a small pocket is provided for each flap when pushed aside by the cannula, said pockets being the only regions of the seal for fluid collection when the flaps block the internal passage;

(c) the sealing structure providing substantially no volume unswept by flow through said access device internal passage other than a storage volume for the retracted movable portion that is filled by said portion upon retraction to thereby expel fluid, collected therein during sealing, back into the flow passage as the cannula is reinserted.

18. Device in accordance with claim 17 wherein wire springs are provided to urge the flaps into closing position.

19. In an access device for subcutaneous access for transfer of fluid into and/or out of a human or animal body and defining an internal passage therein for access at one end by a cannula passing through the skin and at the other end by a proximal end of an implanted conduit such as a catheter, and wherein strain relief is provided, said strain relief comprising a web enclosure that is capable of surrounding the access device and the proximal end of the catheter to avoid catheter distortion while allowing the access device to pivot under the skin.

20. A device in accordance with claim 19 wherein said strain relief web enclosure folds over said access device and may be unfolded to allow opening up for insertion of the device and catheter end.

21. A device as defined in claim 20 wherein said web enclosure encloses more than one access device.

22. Device in accordance with any of claims 19, 20 or 24 with the strain relief pivotable within the human or animal body to vary the passage access and location.

23. In an access device for an assembly to leave a streamlined flow passage from an external flow passage through a structure, a cannula having a distal end, an access device passage and a catheter subcutaneous access for transfer of fluid into and/or out of a human or animal body and defining an internal passage therein for access at one end by a cannula passing through the skin and at the other end by an implanted conduit such as a catheter, the improvement therein and further comprising:

a needle assembly comprising a thin walled cannula shell and an internal obturator rod, the rod having a distal end that protrudes out of the cannula distal end so that the assembly can penetrate the skin, guide an access end of the device and pass through the passage without scoring or otherwise marring passage defining walls, wherein said protruding end is of generally conical form, has a distal endmost section and next-to-endmost section (collar), the latter blending smoothly into a needle and the former providing the principal skin cutting portion in a way that penetrates skin without making long tears therein, wherein the protruding end is faceted with a first series of facets at said distal end and a second series of facets at the collar of greater number than the first series.

24. Device in accordance with any of claims 23 and further comprising an air escape passage along the needle assembly length.

25. Device in accordance with claim 24 wherein an elongated chordally cut-away section of the obturator provides such air escape passage within a round cannula interior.

26. Device in accordance with claim 23 wherein the device is ganged with a hub structure external to the human or animal body and the needle cannula shell is extendible from a cannula proximal end within the hub structure to within a subcutaneously implanted access device,

an obturator extending through said hub structure via a second passageway and through said cannula,

the hub structure having an internal flow passage blending smoothly with said second passageway at said cannula proximal end,

the obturator being removable from the needle assembly to leave a streamlined flow passage from an external flow passage through the hub structure, cannula, access device passage and catheter.