Subcutaneous peritoneal injection catheter

• US 4,405,305 A
• Filed: 02/17/1981
• Issued: 09/20/1983
• Est. Priority Date: 10/27/1980
• Status: Expired due to Fees

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: Jacobsen, Stephen C., Hanover, Barry K., Stephen, Robert L., Harrow, Jeffrey J., Kablitz, Carl
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/235,185
• Time in Patent Office: 945 Days
• Field of Search: 128/214 R, 128/274, 128/213 A, 128/348-350, 604/28, 604/29, 604/49, 604/175, 604/8-10
• US Class Current: 604/502
• 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 novel implantable, peritoneal injection catheter apparatus and method, the apparatus including an open top, fluid-receiving reservoir mounted to one end of a hollow stem and a penetrable membrane covering the open top of the receiving reservoir. The hollow stem is configurated to extend into the peritoneal cavity and includes a retaining flange system for retaining the hollow stem in fluid communication with the peritoneal cavity. The penetrable membrane serves as an injection site for inserting a hollow needle into the receiving reservoir. The penetrable membrane also includes a dome configuration that may be depressed to expel injection fluids from the reservoir into the peritoneal cavity. A substantial portion of the injection catheter is covered with a velour coating to accomodate tissue ingrowth for further securement of the catheter in the tissue of the abdominal wall.

Claims

1. A subcutaneous conduit for injecting a drug into a peritoneal cavity, comprising:

an injection receiver having a diametrally enlarged, convergent receiving surface and an opening in the receiving surface;

a diametrally enlarged, penetrable cover across the receiving surface in spaced relationship therewith, the cover forming a receiving reservoir in combination with the receiving surface;

a hollow stem having a proximal end and a distal end, the proximal end of the stem being attached to the injection receiver such that the stem forms a passageway extending from the opening in the receiving surface, the stem having a length sufficient that the stem penetrates the parietal peritoneal membrane and extends into the peritoneal cavity; and

a diametrally enlarged flange attached to the stem such that, when the conduit is implanted under a layer of skin adjacent the peritoneal cavity and the flange is secured adjacent the parietal peritoneal membrane, the distal end of the hollow stem is directed toward the mesenteric peritoneal membrane.

2. A subcutaneous conduit as defined in claim 1 wherein the injection receiver comprises a penetration-resistant material.

3. A subcutaneous conduit as defined in claim 1 wherein the injection receiver comprises a generally circular periphery around the convergent receiving surface and a raised rim circumscribing the periphery, the rim assisting the cover in defining the receiving reservoir.

4. A subcutaneous conduit as defined in claim 3 wherein the injection receiver further comprises an annular shelf below the rim and the cover comprises an annular lip that is engagedly received by the shelf.

5. A subcutaneous conduit as defined in claim 1 wherein the diametrally enlarged flange is attached adjacent the distal end of the hollow stem, the flange thereby inhibiting the stem from retracting into tissue into which the conduit is implanted.

6. A subcutaneous conduit as defined in claim 1 wherein the injection receiver includes a bore which is countersunk into the receiver from the side opposite the convergent surface, the countersunk bore receiving the hollow stem with the passageway in alignment with the opening.

7. A subcutaneous conduit as defined in claim 1 wherein the penetrable cover is fabricated from a resilient material and with a dome-like configuration, the dome extending away from the receiving surface.

8. A subcutaneous conduit as defined in claim 1 wherein the cover comprises a circumferential groove, the groove serving a a channel for receiving a suture means, the suture means securing the cover to the injection receiver.

9. A subcutaneous conduit as defined in claim 1 wherein the conduit comprises a velour covering over at least a portion of the external surface of the conduit, the velour covering comprising a biocompatible material and providing for tissue ingrowth into the velour material.

10. A subcutaneously implantable injection conduit for injecting a drug into a peritoneal cavity, comprising:

a hollow receptacle for receiving the drug, the hollow receptacle being formed as an open-top chamber;

a penetrable membrane over the open top of the chamber;

a hollow stem having a proximal end and a distal end, the proximal end of the stem being attached to the receptacle such that the stem forms a passageway extending from the chamber, the stem having a length sufficient that the stem penetrates the parietal peritoneal membrane and extends into the peritoneal cavity;

a diametrally enlarged flange attached to the stem such that, when the conduit is implanted under a layer of skin adjacent the peritoneal cavity and the flange is secured adjacent the parietal peritoneal membrane, the distal end of the hollow stem is directed toward the mesenteric peritoneal membrane; and

mounting means for mounting the receptacle under a layer of skin adjacent the peritoneal cavity.

11. A subcutaneously implantable injection conduit as defined in claim 10 wherein the receptacle comprises a cavity formed as an inverted, right frustoconical vessel having a diameter greater than depth with a circular base forming the open top of the chamber and connected at the apex of the frustoconical vessel to the hollow stem.

12. A subcutaneously implantable injection conduit as defined in claim 10 wherein the receptacle comprises a funnel-shaped receiver and the hollow stem is mounted to the apex of the funnel-shaped receiver.

13. A subcutaneously implantable injection conduit as defined in claim 12 wherein the apex of the funnel-shaped receiver includes a countersunk bore and the hollow stem is telescopically mounted in the bore.

14. A subcutaneously implantable injection conduit as defined in claim 13 wherein the hollow stem is fabricated from a suitable material to accommodate the hollow stem being adjustable in length.

15. A subcutaneously implantable injection conduit as defined in claim 10 wherein the diametrally enlarged flange is attached adjacent the distal end of the hollow stem, the flange thereby inhibiting the stem from retracting into tissue into which the conduit is implanted.

16. A subcutaneously implantable injection conduit as defined in claim 10 wherein the mounting means comprises a velour covering over the injection conduit, the velour accommodating tissue ingrowth.

17. A subcutaneously implantable injection conduit as defined in claim 10 wherein the penetrable membrane is fabricated with a dome configuration from a resilient material, the dome allowing the penetrable membrane to be depressed to expel the drug from the receptacle.

18. A method for injecting a drug into a peritoneal cavity in a direction toward the mesenteric peritoneal membrane, the method comprising the steps of:

obtaining an injection conduit, comprising;

a shallow vessel with an open top;

a penetrable membrane covering the open top of the vessel;

a hollow stem having a proximal end and a distal end, the proximal end of the stem being attached to the vessel such that the stem forms a passageway extending from the vessel; and

a diametrally enlarged flange attached to the stem such that, when the conduit is implanted underneath a layer of skin adjacent the peritoneal cavity and the flange is secured adjacent the parietal peritoneal membrane, the distal end of the hollow stem is directed toward the mesenteric peritoneal membrane;

implanting the injection conduit underneath a layer of skin adjacent the peritoneal cavity with the membrane being generally parallel to the skin, the hollow stem penetrating the parietal peritoneal membrane and extending into the peritoneal cavity, the diametrally enlarged flange being secured adjacent the parietal peritoneal membrane, the distal end of the hollow stem being directed toward the mesenteric peritoneal membrane, and the passageway communicating between the vessel and the peritoneal cavity; and

injecting a drug into the peritoneal cavity by penetrating the layer of skin and the penetrable membrane with a hollow needle and forcing the drug through the hollow needle into the vessel with the hollow stem carrying the drug into the peritoneal cavity in a direction toward the mesenteric peritoneal membrane.

19. A method as defined in claim 18 wherein the implanting step further comprises securing the hollow stem in the peritoneal cavity thereby preventing dislodgement of the hollow stem.

20. A method as defined in claim 18 wherein the injection circuit further comprises a biocompatible velour material covering at least a portion of the injection conduit, the biocompatible velour material providing for tissue ingrowth into the velour material after implanting the injection conduit.

21. A method as defined in claim 18 wherein the vessel is fabricated from a puncture-resistant material.

22. A method as defined in claim 18 wherein the diametrally enlarged flange is attached adjacent the distal end of the stem, the flange thereby inhibiting the stem from retracting into tissue into which the injection conduit is implanted.

23. A method as defined in claim 18 wherein the penetrable membrane is fabricated from a resilient material and with a dome-like configuration, the dome extending away from the vessel.

24. A method as defined in claim 23 wherein the injecting step further comprises selectively, manually depressing the dome thereby expelling the drug from the vessel into the peritoneal cavity in a direction toward the mesenteric peritoneal membrane.

25. A method as defined in claim 24 wherein the depressing step comprises manually releasing the dome, the resilient material returning the dome to its dome-like configuration and repeating the depressing step thereby flushing the vessel.

26. A method as defined in claim 18 wherein the vessel comprises a diametrally enlarged convergent receiving surface.

27. A method as defined in claim 18 wherein the drug is insulin and wherein the insulin, upon entering the peritoneal cavity through the hollow stem so as to contact the mesenteric peritoneal membrane, is absorbed into the blood circulation of the portal venous system via said mesenteric peritoneal membrane, whereby the insulin is transported directly to the liver.

28. A peritoneal catheter comprising:

a body having a diametrally enlarged, convergent receiving surface and having an opening in the receiving surface, a periphery around the receiving surface, a raised rim circumscribing the periphery, and a shelf below the rim;

a hollow stem attached to the body, the stem forming a passageway extending from the opening; and

a diametrally enlarged, penetrable cover across the receiving surface in spaced relationship therewith, the cover being assisted by the rim in forming a receiving reservoir in combination with the receiving surface, and the cover having a lip that is engagedly received by the shelf.

29. An implantable peritoneal injection catheter, comprising:

a body having a penetration-resistant, diametrally enlarged, convergent receiving surface and an opening at the center of the receiving surface, said body comprising a circular periphery around the convergent receiving surface, a raised rim circumscribing the periphery, an annular shelf below the rim, and a bore which is countersunk into the body from the side opposite the convergent surface such that the countersunk bore is in alignment with the opening;

a diametrally enlarged, penetrable cover across the receiving surface in spaced relationship therewith, the cover being assisted by the raised rim in forming a receiving reservoir in combination with the receiving surface, the cover comprising an annular lip that is engagedly received by the shelf, and the cover being fabricated from a resilient material and having a dome-like configuration, the dome extending away from the receiving surface; and

a hollow stem having a proximal end and a distal end, the proximal end of the stem being telescopically received into the countersunk bore such that the stem forms a passageway extending from the opening, the distal end of the stem being formed as a diametrally enlarged flange, and the stem having a predetermined length such that, when the catheter is implanted under a layer of skin adjacent to a peritoneal cavity, the stem extends from the body into the peritoneal cavity with the distal end of the stem being inside the peritoneal cavity and the enlarged flange residing against a wall of the peritoneal cavity so as to surround a point on the wall of the peritoneal cavity through which the stem enters the peritoneal cavity, the stem thereby accommodating fluid communication into the peritoneal cavity, and the flange inhibiting the stem from retracting into tissue into which the catheter is implanted.

30. The implantable peritoneal injection catheter defined in claim 29 wherein the cover further comprises a circumferential groove, the groove serving as a channel for receiving a suture means, the suture means securing the cover to the body.

31. The implantable peritoneal injection catheter defined in claim 29 further comprising means for mounting the catheter under a layer of skin adjacent to the peritoneal cavity, said mounting means comprising a biocompatible velour covering over at least a portion of the external surface of the peritoneal catheter, the velour covering providing for tissue ingrowth into the velour material.

32. A subcutaneously implantable injection conduit for injecting insulin into a peritoneal cavity in a direction toward the mesenteric peritoneal membrane, comprising:

an injection receiver having a penetration-resistant, diametrally enlarged, convergent receiving surface and an opening at the center of the receiving surface, said injection receiver comprising a circular periphery around the convergent receiving surface, a raised rim circumscribing the periphery, an annular shelf below the rim, and a bore which is countersunk into the injection receiver from the side opposite the convergent surface such that the countersunk bore is in alignment with the opening;

a diametrally enlarged, penetrable cover across the receiving surface in spaced relationship therewith, the cover being assisted by the raised rim in forming a receiving reservoir in combination with the receiving surface, the cover comprising an annular lip that is engagedly received by the annular shelf, and the cover being fabricated from a resilient material and having a dome-like configuration, the dome extending away from the receiving surface;

a hollow stem having a proximal end and a distal end, the proximal end of the stem being telescopically received into the countersunk bore in the injection receiver such that the stem forms a passageway extending from the opening in the receiving surface, and the stem having a length sufficient that, when the injection conduit is implanted in tissue adjacent the peritoneal cavity, the stem penetrates the parietal peritoneal membrane and extends from the injection receiver into the peritoneal cavity; and

a diametrally enlarged flange attached adjacent the distal end of the hollow stem such that the flange inhibits the stem from retracting into tissue into which the conduit is implanted, and such that, when the flange is secured adjacent the parietal peritoneal membrane, the distal end of the stem is directed toward the mesenteric peritoneal membrane, whereby the insulin, upon entering the peritoneal cavity through the hollow stem, contacts the mesenteric peritoneal membrane and is absorbed into the blood circulation of the portal venous system via said mesenteric peritoneal membrane, whereby the insulin is transported directly to the liver.

33. A subcutaneously implantable injection conduit as defined in claim 32 further comprising means for mounting the conduit in tissue adjacent the peritoneal cavity, said mounting means comprising a biocompatible velour covering over at least a portion of the external surface of the conduit, the velour covering providing for tissue ingrowth into the velour material.