# US 11,305,333 B2 · Methods for forming low stress component for medical devices

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- Number: US 11,305,333 B2
- Document ID: US11305333B2
- Status: Granted
- Kind: B2
- Application number: 16/836,356
- Filed: 2020-03-31
- Published: 2021-09-30
- Granted: 2022-04-19
- Earliest claimed: 2020-03-31
- Assignees: Insulet Corporation
- Applicants: Insulet Corporation
- Inventors: Ian McLaughlin
- Web page: https://patentgrep.com/patent/US11305333B2

## CPC

- B21K 1/20: valve parts
- B23P 15/00: Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
- A61M 39/00: Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use (for respiratory devices, e.g. tracheal tubes, A61M16/00; artificial heart valves A61F2/24)
- B21K: MAKING FORGED OR PRESSED METAL PRODUCTS, e.g. HORSE-SHOES, RIVETS, BOLTS OR WHEELS (making particular articles by working sheet metal without essentially removing material B21D; processing wire B21F; making pins, needles or nails B21G; making particular articles by rolling B21H; forging machines, pressing machines, hammering machines, in general B21J; making chains B21L; plating B23K)
- B23P: METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS (arrangements for copying or controlling B23Q)
- 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

Disclosed herein are approaches of forming a component, such as a valve, for a medical device. One approach includes providing a cylinder within a tube, the tube and the cylinder joined together in an interference fit, and annealing the tube and the cylinder, wherein the tube and the cylinder are no longer joined together in the interference fit following the annealing.

## Claims

### Claim 1

A method of forming a device for a wearable drug delivery system, the method comprising:
joining together a first component within an interior of a second component, wherein the first and second components are engaged together in an interference fit;
annealing the first and second components; and
cooling the first and second components after the annealing until the first and second components are no longer engaged together in the interference fit.

### Claim 2 (depends on 1)

The method of claim 1, further comprising pressing the second component over an exterior of the first component to cause the second component to expand.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first and second components are the same or different materials.

### Claim 4 (depends on 1)

The method of claim 1, further comprising causing the first component to elongate after the annealing.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
providing a central port through the first component;
providing an exterior port through the second component; and
actuating the first and second components with respect to one another to align the central port with the exterior port.

### Claim 6 (depends on 1)

The method of claim 1, wherein actuating the first and second components comprises rotating the first and second components with respect to one another or axially moving the first and second components with respect to one another.

### Claim 7

A method of forming a valve for a medical device, comprising:
providing a cylinder within a tube, the tube and the cylinder joined together in an interference fit such that an outer diameter of the cylinder is greater than an inner diameter of the tube;
annealing the tube and the cylinder; and
cooling the tube and the cylinder, wherein the tube and the cylinder are no longer joined together in the interference fit following the annealing and the cooling.

### Claim 8 (depends on 7)

The method of claim 7, further comprising providing an oil between the tube and the cylinder.

### Claim 9 (depends on 7)

The method of claim 7, further comprising pressing the tube over the cylinder to cause the cylinder to expand.

### Claim 10 (depends on 7)

The method of claim 7, wherein the cylinder and the tube are the same material.

### Claim 11 (depends on 7)

The method of claim 7, wherein the cylinder and the tube are different material.

### Claim 12 (depends on 7)

The method of claim 7, further comprising causing the cylinder to elongate after the annealing.

### Claim 13 (depends on 7)

The method of claim 7, further comprising providing a port through the tube or the cylinder.

### Claim 14 (depends on 7)

The method of claim 7, further comprising:
providing a central port through the cylinder;
providing an exterior port through the tube; and
actuating the tube and the cylinder with respect to one another to align the central port with the exterior port.

### Claim 15

A method of forming a valve for a wearable medical device, comprising:
providing a cylinder within a tube, the tube and the cylinder joined together in an interference fit;
annealing the tube and the cylinder; and
cooling the tube and the cylinder after the annealing until the cylinder and the tube are no longer engaged in the interference fit.

### Claim 16 (depends on 15)

The method of claim 15, further comprising providing an oil between the tube and the cylinder.

### Claim 17 (depends on 15)

The method of claim 15, wherein providing the cylinder within the tube comprises pressing the tube over the cylinder to cause the tube to expand.

### Claim 18 (depends on 15)

The method of claim 15, wherein the cylinder and the tube are the same or different materials.

### Claim 19 (depends on 15)

The method of claim 15, further comprising causing the cylinder to elongate after the annealing.

### Claim 20 (depends on 15)

The method of claim 15, further comprising:
providing a central port through the cylinder;
providing an exterior port through the tube; and
actuating the tube and the cylinder with respect to one another to align the central port with the exterior port.
