Injection port

• US 5,137,529 A
• Filed: 04/02/1991
• Issued: 08/11/1992
• Est. Priority Date: 02/20/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation (Medtronic Plc)
• Inventors: Leicht, Edward C., Heindl, Alfons, Licata, Mark J., Watson, David A.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/679,658
• Time in Patent Office: 497 Days
• Field of Search: 604/86, 604/88, 604/49, 604/93, 604/175, 604/185, 604/123, 604/124, 604/126, 604/891.1, 604/8-10, 128/DIG. 12
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 2039/0241 having means for filtering
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• 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 128/12 Pressure infusion

Abstract

A subcutaneously implantable injection port includes an elastomeric outer housing which encloses an easily assemblage multi-piece rigid base structure. An injection chamber is defined between an upper septum, formed integrally with the elastomeric outer housing, and the underlying base structure. The outer housing includes an upper dome and a lower reinforced sheet. The septum, which is formed integrally with the upper dome, includes a septum flange which is compressed, interiorly of the outer housing, between two base members. A filter extends across the injection chamber dividing it into upper and lower portions. A needle guard, provided by one of the base components, prevents contact between a needle inserted into the injection chamber and the filter. An outlet connector integrally formed with one of the base components extends through the outer housing for connecting a catheter or the like, with the lower portion of the injection chamber. In assembling the injection port, a first base member or rigid outer ring is placed adjacent to an interior surface of the elastomeric outer housing. A filter is placed within a second base member and held securely in place thereon by a third base member which provides the needle guard and fits within the second base member in an interference fit. This assembly is pushed into the first base member in a manner compressing the septum flange and creating a fluid-tight injection chamber.

Claims

1. An injection port, comprising:

an elastomeric outer housing including an integral elastomeric septum;

a first base member situated within the outer housing and contiguously engaging a peripheral flange of the septum;

a second base member situated within the first base member and the outer housing, the second base member contiguously engaging the peripheral flange of the septum opposite the first base member such that the septum is compressed between the first and second base members, wherein the second base member and the septum define an internal chamber;

a filter barrier supported by the second base member, the filter barrier separating the internal chamber into an upper portion adjacent to the septum and a lower portion;

an outlet extending from the lower portion of the internal chamber exteriorly through the outer housing; and

means for sealing an outer peripheral flange of the filter barrier adjacent to the second base member, to require any fluid injected into the upper portion of the internal chamber to pass through the filter barrier before passing through the outlet to exit the injection port, wherein the sealing means includes a needle guard for preventing contact between a needle inserted through the septum into the internal chamber, and the filter barrier.

2. An injection port as set forth in claim 1, wherein the sealing means comprises a third base member which is cup-shaped and includes a filter barrier-engaging base, a continuous wall which extends upwardly therefrom, and a floor spaced from the filter barrier and supported by the base, wherein the continuous wall engages an inner surface of the second base member in an interference fit.

3. An injection port as set forth in claim 2, wherein the third base member includes an upper septum-engaging section which extends upwardly from the continuous wall to underlie the peripheral flange of the septum and compress the peripheral flange of the septum between the first base member and the upper septum-engaging section of the third base member.

4. An injection port as set forth in claim 2, wherein the sealing means includes a gasket disposed between the third base member and the outer peripheral flange of the filter barrier, and wherein the filter barrier comprises a two-tenths micron filter.

5. An injection port as set forth in claim 1, wherein the second base member includes a floor having filter supports extending upwardly therefrom for supporting the filter barrier, the upwardly extending floor supports forming a labyrinth passageway in open fluid communication with the outlet.

6. An injection port as set forth in claim 1, wherein the elastomeric outer housing includes an upper dome attached to a lower reinforced sheet, the upper dome including a lower flange sealed to the reinforced sheet, a frusto-conical side wall extending upwardly from the lower flange, and the septum which is integrally formed with the side wall and supported thereby in spaced relation to the lower reinforced sheet.

7. An injection port as set forth in claim 6, wherein the first base member comprises a generally frusto-conical ring configured to engage and support an interior surface of the side wall, and a rigid upper flange which overlies the peripheral flange of the septum to provide a rigid barrier between the peripheral flange of the septum and the adjacent side wall portions, wherein the upper flange circumscribes the septum and engages the peripheral flange of the septum.

8. An injection port as set forth in claim 7, wherein the second base is cup-shaped and includes a floor and a continuous wall which extends upwardly therefrom, wherein the continuous wall projects from the floor to engage an inner surface of the first base member in an interference fit, the wall including an upper septum-engaging section which underlies the peripheral flange of the septum and compresses the peripheral flange of the septum against the upper flange of the first base member.

9. A subcutaneously implantable injection port, comprising:

an elastomeric outer housing including an upper dome attached to a lower reinforced sheet, the upper dome including a lower flange sealed to the reinforced sheet, a frusto-conical side wall extending upwardly from the lower flange, and a septum integrally formed with the side wall and supported thereby in spaced relation to the lower reinforced sheet, the septum including a peripheral flange which extends circumferentially outwardly from the body of the septum toward the side wall;

a rigid first base member enclosed within the elastomeric outer housing, the first base member comprising a generally frusto-conical ring configured to contiguously engage and support an interior surface of the side wall, and a rigid upper flange, wherein the upper flange overlies the peripheral flange of the septum and provides a rigid barrier between the peripheral flange of the septum and the adjacent side wall portions;

a rigid second base member situated within the first base member and the elastomeric outer housing, the second base member being cup-shaped and including a floor and a continuous wall extending upwardly therefrom, the continuous wall engaging an inner surface of the first base member in an interference fit, the second base member defining, with the septum, an internal injection chamber, the second base member further including an upper septum-engaging section which extends upwardly from the continuous wall to underlie the peripheral flange of the septum and compress the peripheral flange of the septum between the upper flange of the first base member and the upper septum-engaging section of the second base member;

a filter barrier supported by the second base member, the filter barrier separating the injection chamber into an upper portion adjacent to the septum and a lower portion;

means for sealing an outer peripheral flange of the filter barrier adjacent to the second base member, to require any fluid injected into the upper portion of the injection chamber to pass through the filter barrier before exiting the injection port, the sealing means including a needle guard for preventing contact between a needle inserted through the septum into the injection chamber, and the filter barrier, the sealing means comprising a third rigid base member, the third base member being cup-shaped and including a filter barrier-engaging base, a continuous wall which extends upwardly therefrom, and a floor spaced from the filter barrier and supported by the base, the continuous wall of the third base member engaging an inner surface of the second base member in an interference fit; and

an outlet extending from the lower portion of the injection chamber, exteriorly through the housing, wherein the outlet includes a rigid outlet connector formed integrally with the second base member to provide a fluid conduit from an inlet port on an interior surface of the second base member, to an outlet port situated at an opposite end of the outlet connector.

10. An injection port as set forth in claim 9, wherein the third base member includes a upper septum-engaging section which underlies the peripheral flange of the septum and compresses the peripheral flange of the septum against the upper flange of the first base member.

11. An injection port as set forth in claim 9, wherein the sealing means includes a gasket disposed between the third base member and the outer peripheral flange of the filter barrier, and wherein the filter barrier comprises a two-tenths micron filter.

12. An injection port as set forth in claim 9, wherein the floor of the second base member includes filter supports extending upwardly therefrom for supporting the filter barrier, the upwardly extending floor supports forming a labyrinth passageway in open fluid communication with the outlet.

13. An injection port, comprising:

an elastomeric outer housing including an integral elastomeric septum;

a first base member situated within the outer housing and contiguously engaging a peripheral flange of the septum;

a second base member situated within the first base member and the outer housing, the second base member contiguously engaging the peripheral flange of the septum opposite the first base member such that the septum is compressed between the first and second base members, wherein the second base member and the septum define an internal chamber;

a filter barrier supported by the second base member, the filter barrier separating the internal chamber into an upper portion adjacent o the septum and a lower portion; and

an outlet extending from the lower portion of the internal chamber exteriorly through the outer housing;

wherein the second base member includes a floor having filter supports extending upwardly therefrom for supporting the filter barrier, the upwardly extending floor supports forming a labyrinth passageway in open fluid communication with the outlet.

14. An injection port as set forth in claim 13, including means for sealing an outer peripheral flange of the filter barrier adjacent to the second base member, to require any fluid injected into the upper portion of the internal chamber to pass through the filter barrier before passing through the outlet to exit the injection port.

15. An injection port as set forth in claim 13, wherein the elastomeric outer housing includes an upper dome attached to a lower reinforced sheet, the upper dome including a lower flange sealed to the reinforced sheet, a frusto-conical side wall extending upwardly from the lower flange, and the septum which is integrally formed with the side wall and supported thereby in spaced relation to the lower reinforced sheet.

16. An injection port as set forth in claim 15, wherein the first base member comprises a generally frusto-conical ring configured to engage and support an interior surface of the side wall, and a rigid upper flange which overlies the peripheral flange of the septum to provide a rigid barrier between the peripheral flange of the septum and the adjacent side wall portions, wherein the upper flange circumscribes the septum and engages the peripheral flange of the septum.

17. An injection port as set forth in claim 16, wherein the second base is cup-shaped and includes a floor and a continuous wall which extends upwardly therefrom, wherein the continuous wall projects from the floor to engage an inner surface of the first base member in an interference fit, the wall including an upper septum-engaging section which underlies the peripheral flange of the septum and compresses the peripheral flange of the septum against the upper flange of the first base member.