Implantable infusion device

• US 5,057,084 A
• Filed: 03/01/1990
• Issued: 10/15/1991
• Est. Priority Date: 03/01/1990
• Status: Expired due to Term

• Current Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Ensminger, William D., Knol, James A., Andrews, James C.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US07/487,541
• Time in Patent Office: 593 Days
• Field of Search: 604/175, 604/167, 604/256, 604/93, 604/86, 604/244, 604/905, 604/283, 604/4, 604/8-10, 604/49, 128/DIG. 26
• US Class Current: 604/167.04
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0666 Flap-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• 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 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An infusion part for implantation adapted for providing repeated access to specific tissue within a patient and communicating with the tissue by an internal implanted catheter. The infusion ports according to this invention incorporate an enlarged entrance orifice with a funnel shaped internal cavity which narrows down to a reduced diameter passageway. An articulating catheter valve is provided within the passageway which normally prevents the flow of fluids through the valve but can be penetrated by an external introduced filament such as a catheter. After implantation, an external filament which is fed through an incision in the patient as is guided by the port internal cavity into registry with the catheter valve. Continued feeding of the filament causes the catheter to pass through the valves. Thereafter, when a catheter is inserted, therapeutic agents infused within the patient, or body fluids can be withdrawn. Alternate embodiments disclose means for providing a change in direction of the an introduced filament inserted through the infusion device. Additional embodiments disclose the concepts of providing a antimicrobial fluid bath within the device for prevention of infection and various approaches for securely connecting an internal catheter to an infusion port.

Claims

1. An implantable patient access device for permitting access to an internal catheter by a flexible filament such as an external catheter, wire or optical fiber comprising:

a housing defining an entrance orifice and a single exit orifice with said entrance orifice having a cross-sectional open area which decreases from said entrance orifice to a passageway communicating with said exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to enter and pass through said passageway,

at least one articulating catheter valve positioned with said housing passageway which normally remains closed to provide resistance to flow of fluids through said valve, yet opens when contacted to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter through said exit orifice, and

mounting means formed by said housing for enabling a fastener to affix said housing subcutaneously.

2. An implantable patient access device according to claim 1 wherein said catheter valve comprises a leaflet valve having a generally circular flat disk of a resilient material with at least one cut through said disk which crosses the center of said disk.

3. An implantable patient access device according to claim 2 wherein said device includes at least two of said leaflet valves which are stacked together and are oriented so that said cuts of a first of said valves are not aligned with said cuts of a second of said valve disks.

4. An implantable patient access device according to claim 1 wherein said catheter valve comprises a cup valve having a nipple with an exit side and a valve cup for sealing engagement with said nipple, and means for resiliently urging said cup to seal against said nipple, and said cup valve oriented such that said filament unseats said cup from said nipple when introduced into said access device.

5. An implantable patient access device according to claim 1 wherein said catheter valve comprises a ball-and-seat type valve wherein said ball sealingly engages with a seat formed by said access device and said ball is urged to unseat from said seat when said filament is introduced into said access device.

6. An implantable patient access device according to claim 1 wherein said access device comprises at least two of said articulating catheter valves positioned within said housing and separated to define an antimicrobial fluid reservoir.

7. An implantable patient access device according to claim 1 wherein said device further comprises an elastic septum covering said entrance orifice and having a preformed slit therethrough.

8. An implantable patient access device according to claim 1 wherein said entrance orifice defines a generally circular perimeter and wherein said passageway is an elongated cylindrical bore with said entrance orifice concentric with said passageway.

9. An implantable patient access device according to claim 1 wherein said entrance orifice defines a generally circular perimeter lying on a plane positioned such that a line normal to said plane forms a right angle to the central axis of said passageway with said housing orifice shaped to guide said filament inserted into said entrance orifice to bend and become inserted through said catheter valve.

10. An implantable patient infusion access according to claim 1 wherein said entrance orifice defines a plane which is oriented such that a line normal to said plane forms an obtuse angle with respect to a central longitudinal axis through said exit orifice.

11. An implantable patient access device according to claim 1 wherein said entrance orifice has a cross-sectional area at least four times that of the cross-sectional area of said passageway.

12. An implantable patient access device according to claim 1 wherein said access device exit orifice defines an annular pocket formed between inner and outer tubular portions with an end of said internal catheter fitting over said inner tubular portion and within said annular pocket.

13. An implantable patient access device according to claim 1 further comprising a compression ring for compressing said internal catheter radially inwardly against said access device housing.

14. An implantable patient access device according to claim 1 further comprising a compression ring for comprising an end of said internal catheter attached to said access device radially inwardly against said access device housing.

15. An implantable patient access device according to claim 1 wherein said access device exit orifice defines an externally ribbed nipple with an end of said internal catheter positioned around said nipple.

16. An implantable patient access device according to claim 15 further comprising a compression ring for compressing said internal catheter end radially inwardly against said access device housing.

17. An implantable patient access device according to claim 1 wherein said access device exit orifice defines an annular gap formed between an inner and outer tubular portion, with an end of the internal catheter disposed within said gap and having a compression ring having means for interlocking with said outer tubular portion.

18. A method for permitting repeated access to preselected tissue within a patient by a filament such as an external catheter, wire or optical fiber, comprising the steps of:

providing an implantable access device having an enlarged funnel shaped entrance orifice and a single exit orifice with an articulating catheter valve positioned between said orifices which normally resists the flow of fluids through said valve,

providing an internal catheter connectable to said device exit orifice,

making an incision in the patient'"'"'s skin,

implanting said device subcutaneously within the patient,

mounting said access device to subcutaneously patient tissue using a fastener engaging a mounting feature of said device,

positioning said internal catheter to communicate from the device exit orifice to said preselected tissue,

providing a flexible filament,

inserting said filament through an incision and into said device entrance orifice, and

feeding said filament through said articulating catheter valve, thereby providing said access to said preselected tissue.

19. The method according to claim 18 further comprising the steps of:

providing a skin punch having a flat elongated blade with a flange and making said incision by pushing said punch against the patient'"'"'s skin causing said blade to cut the skin and said flange limiting the depth of said incision.

20. The method according to claim 18 further comprising the step of providing a semi-rigid guide wire and inserting said wire into an external catheter to add rigidity to said external catheter to facilitate insertion of said catheter.

21. A method for permitting repeated access to preselected tissue within a patient by a filament such as an external catheter, wire or optical fiber, comprising the steps of:

providing an implantable access device having an enlarged funnel shaped entrance orifice, and an exit orifice with an articulating catheter valve positioned between said orifices which normally resists the flow of fluids through said valve,

providing an internal catheter connectable to said device exit orifice,

providing a skin punch having a flat elongated blade with a flange,

making an incision in the patient'"'"'s skin by pushing said punch against the patient'"'"'s skin causing said blade to cut the skin and said flange limiting the depth of said incision,

implanting said device subcutaneously within a patient,

positioning said internal catheter to communicate from the device exit orifice to said preselected tissue,

providing a flexible filament,

inserting said filament through an incision and into said device entrance orifice, and

feeding said filament through said articulating catheter valve, thereby providing said access to said preselected tissue.

22. A method for permitting repeated access to preselected tissue within a patient by an external catheter, comprising the steps of:

providing an implantable access device having an enlarged funnel shaped entrance orifice, and an exit orifice with an articulating catheter valve positioned between said orifices which normally resists the flow of fluids through said valve,

providing an internal catheter connectable to said device exit orifice,

making an incision in the patient'"'"'s skin,

implanting said device subcutaneously within the patient,

positioning said internal catheter to communicate from the device to said preselected tissue,

providing a semi-rigid guide wire and inserting said wire into said external catheter to add rigidity to said external catheter to facilitate insertion of said external catheter,

inserting said external catheter through said incision and into said device entrance orifice, and

feeding said external catheter through said articulating catheter valve, thereby providing said access to said preselected tissue.