Tumor access device and method for delivering medication into a body cavity

• US 5,112,303 A
• Filed: 05/02/1991
• Issued: 05/12/1992
• Est. Priority Date: 05/02/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation
• Inventors: Pudenz, Robert H., East, Gary P.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, C.
• Application Number:
  US07/694,679
• Time in Patent Office: 376 Days
• Field of Search: 604/8, 604/27-28, 604/48-49, 604/93, 604/96-97, 604/100, 604/131, 604/153, 604/173-175, 604/183, 604/891.1, 606/191-192, 128/DIG. 12
• US Class Current: 604/502
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 method for delivering a medication into a body cavity includes the steps of inflating a flexible bag within the body cavity such that the flexible bag expands to fill most of the void of the body cavity, and injecting medication into the space between an exterior surface of the flexible bag and the cavity wall such that the medication substantially surrounds the flexible bag and fills the remaining void. The steps of inflating the flexible bag and injecting medication are accomplished through subcutaneous injection at a site remote from the body cavity. To accomplish this, a surgically implantable tumor access device includes co-located first and second injection ports, for respectively, receiving a sterile fluid and a fluid medication. A flexible fluid conduit, which includes two coaxial tubes, directs the injected fluids, in a manner providing separate fluid flow paths, to a point adjacent to an inlet for the flexible bag. An inner tube fluidly connects the flexible bag with the first injection port. An outer tube surrounding the inner tube directs medication from the second injection port to medication delivery tubes fixed to an exterior surface of the flexible bag.

Claims

1. A surgically implantable device for accessing a body cavity through a relatively small cavity wall aperture, and delivering medication through the device into the body cavity, the device comprising:

means for receiving a first fluid subcutaneously by injection into the device at a location remote from the body cavity;

a first conduit extending from the first fluid receiving means to the cavity wall aperture;

a flexible, fluid impermeable bag configured for insertion into the body cavity through the cavity wall aperture, the fluid impermeable bag having an exterior surface and a bag inlet connected to the first conduit opposite to the first fluid receiving means such that fluid injected into the first fluid receiving means flows into the fluid impermeable bag to inflate it within the body cavity, and such that fluid withdrawn from the first fluid receiving means collapses the fluid impermeable bag permitting it to be withdrawn from the body cavity;

means for receiving by injection, at a location remote from the fluid impermeable bag, medication into the device;

a second conduit connected to the medication receiving means and extending adjacent to the first conduit to the cavity wall aperture; and

means for delivering the medication from the medication receiving means into a space between walls defining the body cavity and the exterior surface of the fluid impermeable bag, wherein the medication delivering means includes at least one medication outlet which directs the medication injected into the medication receiving means into said space such that the medication substantially surrounds the fluid impermeable bag.

2. A device as set forth in claim 1, wherein the fluid impermeable bag includes encircling radiopaque markers.

3. A device as set forth in claim 1, wherein the second conduit is coaxial with and surrounds at least a portion of the first conduit.

5. A device as set forth in claim 1, wherein the first fluid receiving means includes a first injection port comprising a first base and a first self-sealing dome which define therebetween a fluid injection chamber, and wherein the medication receiving means includes a second injection port comprising a second base and a second self-sealing dome which define therebetween a medication injection chamber, and wherein the first and second injection ports are co-located and share a common base, wherein a needle guard is positioned within each of the injection chambers adjacent to the base.

6. A surgically implantable device for accessing a body cavity through a relatively small cavity wall aperture, and delivering medication through the device into the body cavity, the device comprising:

a flexible, fluid impermeable bag configured for insertion into the body cavity through the cavity wall aperture, the fluid impermeable bag having a bag inlet and an exterior surface;

means for receiving by injection, at a location remote from the fluid impermeable bag, a fluid utilized for inflating the fluid impermeable bag;

a fluid conduit connecting the fluid impermeable bag to the inflating fluid receiving means, such that fluid injected into the inflating fluid receiving means passes through the fluid conduit and the bag inlet to inflate the fluid impermeable bag;

means for receiving by injection, at a location remote from the fluid impermeable bag, medication into the device; and

means for delivering the medication from the medication receiving means into a space between the walls of the body cavity and the exterior surface of the fluid impermeable bag;

wherein the inflating fluid receiving means includes a first injection port comprising the first base and a first self-sealing dome which define therebetween a fluid injection chamber, wherein a first open end of the fluid conduit is attached to the first injection port such that fluid injected into the fluid injection chamber freely passes through the first open end of the fluid conduit for delivery to the fluid impermeable bag.

7. A device as set forth in claim 6, wherein the medication receiving means includes a second injection port comprising a second base and a second self-sealing dome which define therebetween a medication injection chamber, wherein a second open end of the fluid conduit is attached to the second injection port such that fluid injected into the medication injection chamber freely passes through the second open end of the fluid conduit for delivery to the medication delivering means.

8. A device as set forth in claim 7, wherein the first and second injection ports are co-located and share a common base, and wherein a needle guard is positioned within each of the injection chambers adjacent to the base.

9. A surgically implantable device for accessing a body cavity through a relatively small cavity wall aperture, and delivering medication through the device into the body cavity, the device comprising:

a flexible, fluid impermeable bag configured for insertion into the body cavity through the cavity wall aperture, the fluid impermeable bag having a bag inlet and an exterior surface;

means for receiving by injection, at a location remote from the fluid impermeable bag, a fluid utilized for inflating the fluid impermeable bag;

a fluid conduit connecting the fluid impermeable bag to the inflating fluid receiving means, such that fluid injected into the inflating fluid receiving means passes through the fluid conduit and the bag inlet to inflate the fluid impermeable bag;

means for receiving by injection, at a location remote from the fluid impermeable bag, medication into the device; and

means for delivering the medication from the medication receiving means into a space between the walls of the body cavity and the exterior surface of the fluid impermeable bag;

wherein the fluid conduit extends between and connects the medication receiving means and the medication delivering means, such that fluid injected into the medication receiving means passes through the fluid conduit into the medication delivering means for passage into the space between the walls of the body cavity and the exterior surface of the fluid impermeable bag, and wherein the fluid conduit includes a first section of tubing having a first end which receives fluid injected into the inflating fluid receiving means, and a second end which discharges fluid passing therethrough into the fluid impermeable bag through the bag inlet, the fluid conduit further including a second section of tubing which is coaxial with and surrounds the first section of tubing for at least a portion of the length of the fluid conduit, and which has a first end which receives fluid injected into the medication receiving means, and a second end which discharges fluid into the medication delivering means.

4. A device as set forth in claim 12, wherein the medication delivering means includes a plurality of medicinal tubes, each having a first end in fluid communication with the second conduit, wherein the medicinal tubes are attached to and extend substantially equidistantly about a portion of the exterior surface of the fluid impermeable bag, each of said medicinal tubes including a plurality of medication outlets.

10. A device as set forth in claim 9, wherein the fluid impermeable bag includes radiopaque markers.

11. A device as set forth in claim 9, wherein the fluid impermeable bag is distensible to accommodate varied body cavity geometries.

12. A device as set forth in claim 9, wherein the medication delivering means includes at least one medicinal tube having an end in fluid communication with medication injected into the medication receiving means, wherein the medicinal tube is attached to and extends about a portion of the exterior surface of the fluid impermeable bag, and includes at least one aperture through which medication is delivered into the space between the walls of the body cavity and the exterior surface of the fluid impermeable bag.

13. A device as set forth in claim 12, wherein the medication delivering means includes a plurality of medicinal tubes each having a first end in fluid communication with medication injected into the medication receiving means, and a second plugged end, wherein the medicinal tubes are attached to and extend substantially equidistantly about a portion of the exterior surface of the fluid impermeable bag, and each includes at least one aperture through which medication is delivered into the space between the walls of the body cavity and the exterior surface of the fluid impermeable bag.

14. A device as set forth in claim 9, wherein the inflating fluid receiving means includes a first injection port comprising a firs base and a first self-sealing dome which define therebetween a fluid injection chamber, wherein a first open end of the fluid conduit is attached to the first injection port such that fluid injected to the fluid injection chamber freely passes through the first open end of the fluid conduit for delivery to the fluid impermeable bag.

15. A device as set forth in claim 14, wherein the medication receiving means includes a second injection port comprising a second base and a second self-sealing dome which define therebetween a medication injection chamber, wherein a second open end of the fluid conduit is attached to the second injection port such that fluid injected into the medication injection chamber freely passes through the second open end of the fluid conduit for delivery to the medication delivering means.

16. A device as set forth in claim 15, wherein the first and second injection ports are co-located and share a common base, and wherein a needle guard is positioned within each of the injection chambers adjacent to the base.

17. A method for delivering a medication into a body cavity, the steps comprising:

inflating a flexible bag within the body cavity utilizing a sterile fluid, such that the flexible bag expands a fill most of the void of the body cavity; and

injecting medication into the space between an exterior surface of the flexible bag and the cavity wall such that the medication substantially surrounds the flexible bag and fills the remaining void;

wherein the steps of inflating the flexible bag and injecting medication are accomplished through subcutaneous injection at a site remote from the body cavity.

18. A method as set forth in claim 17, including the step of inserting the flexible bag into the body cavity through a cavity wall aperture, wherein the fluid impermeable bag includes a bag inlet and an exterior surface, and the step of implanting a fluid conduit which connects the fluid impermeable bag to the injection site such that fluid injected into the injection site passes through the fluid conduit to the bag inlet for inflating the flexible bag within the body cavity.

19. A method as set forth in claim 18, wherein the injection site comprises means for receiving by injection the sterile fluid utilized to inflate the fluid impermeable bag, and means for receiving by injection a medication into the device, wherein the medication receiving means is separable from the inflating fluid receiving means.

20. A method as set forth in claim 19, wherein the fluid conduit includes a first section of tubing having a first end which receives fluid injected into the inflating fluid receiving means, and a second end which discharges fluid passing therethrough into the fluid impermeable bag such that fluid injected into the inflating fluid receiving means inflates the flexible bag within the body cavity.

21. A method as set forth in claim 20, wherein the fluid conduit includes a second section of tubing having a first end which receives fluid injected into the medication receiving means, and a second end which discharges fluid in a manner permitting delivery thereof into the space between the exterior surface of the flexible bag and the cavity wall.

22. A method as set forth in claim 21, wherein the second section of tubing is coaxial with and surrounds the first section of tubing for at least a portion of the length of the fluid conduit.

23. A method as set forth in claim 19, wherein the inflating fluid receiving means includes a first base and a first self-sealing dome which define therebetween a fluid injection chamber, wherein the medication receiving means comprises a second base and a second self-sealing dome which define therebetween a medication injection chamber, and wherein the inflating fluid receiving means and the medication receiving means are co-located such that the first and second bases form a unitary base structure.

24. A method as set forth in claim 18, wherein the step of injecting medication utilizes means for delivering the medication into the space between the exterior surface of the flexible bag and the cavity wall, wherein the medication delivering means includes at least one medicinal tube having an end in fluid communication with the fluid conduit, wherein the medicinal tube is attached to and extends about a portion of the exterior surface of the fluid impermeable bag and includes a plurality of apertures through which medication is delivered into the space between the walls of the body cavity and the exterior surface of the fluid impermeable bag.

25. A method as set forth in claim 24, wherein the medication delivering means includes a plurality of medicinal tubes, each having a first end in fluid communication with medication injected at the injection site, and a second plugged end, wherein the medicinal tubes are attached to and extend substantially equidistantly about a portion of the exterior surface of the fluid impermeable bag.

26. A method for accessing a body cavity through a relatively small cavity wall aperture, and for delivering medication into the body cavity, the steps comprising:

inserting a flexible, fluid impermeable bag into the body cavity through the cavity wall aperture;

implanting an injection site at a location remote from the body cavity, and a fluid conduit extending between the injection site and a bag inlet;

injecting fluid into the injection site in a manner and in quantities sufficient to inflate the bag to substantially fill the body cavity; and

injecting medication into the injection site such that the medication is directed into the body cavity between the flexible bag and the walls of the body cavity.

27. A method as set forth in claim 26, wherein the fluid conduit includes a first conduit extending from the injection site to the cavity wall aperture, and a second conduit connected to the injection site and coaxially extending with the first conduit to the cavity wall aperture.

28. A method as set forth in claim 27, wherein the step of injecting medication such that the medication is directed into the body cavity between the flexible bag and the walls of the body cavity, is effected by means for delivering the medication from the injection site through the second conduit into a space between the walls defining the body cavity and the exterior surface of the fluid impermeable bag, wherein the medication delivering means includes a plurality of medication outlets which direct the medication injected into the injection site into said space such that the medication substantially surrounds the fluid impermeable bag.

29. A method as set forth in claim 28, wherein the medication delivering means includes at least one medicinal tube having an end in fluid communication with the second fluid conduit, wherein the medicinal tube is attached to and extends about a portion of the exterior surface of the fluid impermeable bag, and includes a plurality of apertures through which medication is delivered into the space between the walls of the body cavity and the exterior surface of the fluid impermeable bag.

30. A method as set forth in claim 27, wherein the injection site includes means for receiving a first fluid subcutaneously by injection into the device at a location remote from the body cavity, the inflating fluid receiving means including a first base and a first self-sealing dome which define therebetween a fluid injection chamber, wherein a first open end of the first conduit is attached to the inflating fluid receiving means such that fluid injected into the fluid injection chamber freely passes through the first open end of the first conduit for delivery to the bag inlet.

31. A method as set forth in claim 30, wherein the injection site further includes means for receiving by injection, at a location remote from the fluid impermeable bag, medication into the device, the medication receiving means including a second base and a second self-sealing dome which define therebetween a medication injection chamber, wherein the first end of the second conduit is attached to the medication receiving means such that fluid injected into the medication injection chamber freely passes through the second conduit, wherein the inflating fluid receiving means and the medication receiving means, although defining separate fluid reception sites, are co-located such that the first and second bases form a unitary base structure, and wherein a needle guard is positioned within each of the injection chambers adjacent to the base.

32. A method as set forth in claim 26, including the step of detecting the configuration of the fluid impermeable bag within the body cavity by means of x-ray detection, wherein for this purpose the fluid impermeable bag includes radiopaque markers.

33. A method as set forth in claim 26, wherein the fluid-impermeable bag is distensible so as to conform to varied body cavity geometries as the bag is inflated.