# US 12,758,740 B2 · Apparatus for retaining and sealing septum in insertion mechanism for fluid delivery device

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- Number: US 12,758,740 B2
- Document ID: US12758740B2
- Status: Granted
- Kind: B2
- Application number: 17/838,938
- Filed: 2022-06-13
- Published: 2022-12-29
- Granted: 2026-10-13
- Earliest claimed: 2021-06-24
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Laura Mejia-Suarez; Alexander Segit; Nitish Kunaparaju
- Web page: https://patentgrep.com/patent/US12758740B2

## CPC

- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 25/0625: {with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism}
- A61M 5/14248: {of the skin patch type}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/1583: {Needle extractors}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 2039/0072: {Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions}
- 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)}

## Abstract

An improved wedge is provided for a septum and wedge subassembly in a fluid path of a fluid delivery device such as for use in a catheter insertion mechanism of a patch pump. The wedge has a retaining edge to provide axial force to retain a septum therein to obviate need for additional insertion mechanism components to retain the septum in place as a needle passes therethrough to facilitate insertion of a catheter and then retracts. The retaining edge can be rolled or flanged to extend at least partially over a surface of the septum. The wedge is also configured to provide radial compression on the septum to achieve a sufficient needle and septum interface seal to withstand a filling pressure of the fluid delivery device.

## Claims

### Claim 1

A septum and wedge assembly for a fluid delivery device comprising:
a septum; and
a wedge comprising:
a cup portion and a stem portion defining a fluid path;
the cup portion being a unitary, integral component formed from a metal and having a continuous, circumferential side wall and a proximal opening dimensioned to receive the septum therein and a distal opening to the fluid path defined by the stem portion, the side wall having an inner diameter that is less than an outer diameter of the septum to provide radial compression on the septum;
wherein the cup portion has a retaining edge along the proximal opening of the side wall, the retaining edge being configured to extend over at least a portion of a proximal surface of the septum that is accessible via the proximal opening and provide an axial force along an axis parallel to the stem portion to retain the septum in the cup portion.

### Claim 2 (depends on 1)

The septum and wedge assembly of claim 1, wherein the retaining edge comprises a rolled retaining edge formed by rolling the retaining edge inwardly with respect to the cup portion and septum received therein, the rolled retaining edge extending a selected distance over the proximal surface of the septum to provide the axial force.

### Claim 3 (depends on 2)

The septum and wedge assembly of claim 2, wherein the retaining edge is coined inwardly with respect to the cup portion to form the rolled retaining edge.

### Claim 4 (depends on 1)

The septum and wedge assembly of claim 1, wherein the retaining edge comprises at least one finger that extends from a portion of the circumferential side wall of the cup portion and has a width less than a circumference of the circumferential side wall, and that is folded inwardly with respect to the cup portion and septum received therein to form a flanged retaining edge that extends a selected distance over the proximal surface of the septum to provide the axial force.

### Claim 5 (depends on 1)

The septum and wedge assembly of claim 1, wherein the retaining edge comprises a plurality of fingers that are folded inwardly with respect to the cup portion and septum received therein to form a flanged retaining edge comprising portions thereof that extend a selected distance over the proximal surface of the septum to provide the axial force.

### Claim 6 (depends on 1)

The septum and wedge assembly of claim 1, wherein the stem portion has an inner diameter that is less than the inner diameter of the cup portion.

### Claim 7 (depends on 6)

The septum and wedge assembly of claim 6, wherein the wedge comprises a flared portion joining the cup portion and the stem portion to define the fluid path, the flared portion having a varying inner diameter that decreases distally and varies from less than the inner diameter of the side wall of cup portion and greater than the inner diameter of the stem portion.

### Claim 8 (depends on 1)

The septum and wedge assembly of claim 1, further comprising a needle, wherein the stem portion has a catheter secured thereto that is dimensioned to slidably receive the needle.

### Claim 9 (depends on 1)

The septum and wedge assembly of claim 1, wherein the wedge is a unitary piece of material chosen from a malleable metal that is biocompatible with a fluid delivered by the fluid delivery device.

### Claim 10 (depends on 9)

The septum and wedge assembly of claim 9, wherein the metal is stainless steel.

### Claim 11 (depends on 1)

The septum and wedge assembly of claim 1, wherein the fluid path of the wedge is fluidically connected to a fluid path from a reservoir of the fluid delivery device, and wherein relative dimensions of the cup portion and the septum are selected to provide a needle-septum interface seal from radial compression that can withstand a designated filling pressure introduced to the fluid path of the wedge when the reservoir in the fluid delivery device undergoes filling.

### Claim 12 (depends on 11)

The septum and wedge assembly of claim 11, wherein the designated filling pressure is 20-55 pounds per square inch.

### Claim 13 (depends on 2)

The septum and wedge assembly of claim 2, wherein the rolled retaining edge comprises an annular ring shape dimensioned with an outer diameter of 2.8 millimeters (mm) and an inner diameter of 2.4 mm, and the cup portion having the septum therein is subjected to crimping and is dimensioned to have a height between 1.4 mm before the crimping and 1.0 mm after the crimping.

### Claim 14 (depends on 1)

The septum and wedge assembly of claim 1, wherein the cup portion having the septum therein is subjected to additional compression in at least one of two directions chosen from being compressed axially to achieve a designated height and being compressed radially to achieve a designated inner diameter.

### Claim 15 (depends on 14)

The septum and wedge assembly of claim 14, wherein the additional compression comprises the cup portion undergoing an axial compression such that the cup portion has a height prior to the axial compression of 1.6 millimeters (mm) with a tolerance of 0.04 mm, and the height of the cup portion after the axial compression is 1.4 mm with a tolerance of 0.05 mm.

### Claim 16 (depends on 14)

The septum and wedge assembly of claim 14, wherein the additional compression comprises the cup portion undergoing a radial compression such that the outer diameter of the septum is 3 millimeters (mm), the cup portion has an inner diameter less than the outer diameter of the septum prior to the radial compression, and the inner diameter of the cup portion is reduced after the radial compression to a diameter chosen from 2.1-2.5 mm.

### Claim 17 (depends on 8)

The septum and wedge assembly of claim 8, wherein the needle pierces the septum to align the needle and septum and wedge assembly.

### Claim 18 (depends on 1)

The septum and wedge assembly of claim 1, wherein the septum is manufactured from an elastomeric material.

### Claim 19 (depends on 1)

The septum and wedge assembly of claim 1, wherein the wedge is manufactured from 304 stainless steel.

### Claim 20 (depends on 1)

The septum and wedge assembly of claim 1, further comprising a catheter hub.