# US 5,137,529 A · Injection port

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- Number: US 5,137,529 A
- Document ID: US5137529A
- Status: Granted
- Kind: A
- Application number: 07/679,658
- Filed: 1991-04-02
- Granted: 1992-08-11
- Earliest claimed: 1990-02-20
- Assignees: Pudenz-Schulte Medical Research Corporation
- Inventors: David A. Watson; Mark J. Licata; Alfons Heindl; Edward C. Leicht
- Web page: https://patentgrep.com/patent/US5137529A

## CPC

- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 2039/0072: {Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions}
- A61M 2039/0229: {having means for facilitating assembling, e.g. snap-fit housing or modular design}
- A61M 2039/0241: {having means for filtering}
- A61M 2205/32: with radio-opaque indicia
- Y10S 128/12: Pressure infusion
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 7)

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.

### Claim 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.

### Claim 10 (depends on 9)

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.

### Claim 11 (depends on 9)

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.

### Claim 12 (depends on 9)

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.

### Claim 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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 13)

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.

### Claim 16 (depends on 15)

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.

### Claim 17 (depends on 16)

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.
