# US 2019/0167912 A1 · Method for producing needle-equipped outer tube and needle-equipped outer tube

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- Number: US 2019/0167912 A1
- Document ID: US20190167912A1
- Status: Published application
- Kind: A1
- Application number: 16/269,193
- Filed: 2019-02-06
- Published: 2019-06-06
- Earliest claimed: 2013-03-07
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Tsutomu SUGIKI; Masaaki KASAI; Kozo MATSUMOTO; Kenta GOTO
- Web page: https://patentgrep.com/patent/US20190167912A1

## CPC

- A61M 5/343: {Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub (A61M5/322 takes precedence)}
- A61M 5/28: Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M 5/3134: {characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula}
- A61M 5/34: Constructions for connecting the needle {, e.g. to syringe nozzle or needle hub (connecting catheter tubes to hubs A61M25/0014)}
- A61M 2005/3118: {via the distal end of a syringe, i.e. syringe end for mounting a needle cannula}
- 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

A method of manufacturing a needle-equipped outer tube includes a preheating step comprising heating a distal end connecting section to a temperature at or below a softening point of a material forming an outer tube member with a joint member inserted in a distal end connecting section of the outer tube member, and with a needle being inserted or inserted and fixed in the needle insertion hole; and a joint member welding step, performed after the preheating step, comprising thermally welding the joint member to the distal end connecting section of the outer tube member with a distal end portion of the joint member pressed toward the proximal end of the joint member by a pushing member with a pressing force in a range of 4 N to 30 N.

## Claims

### Claim 1

A needle-equipped outer tube comprising:
a needle;
a joint member comprising a needle insertion hole penetrating the joint member from a distal end to a proximal end, and a tapered portion in which an outer diameter decreases from a distal end side toward a proximal end side; and
an outer tube member comprising a distal end connecting section having a tapered hollow portion configured to receive the tapered portion of the joint member,
wherein the needle is located in the needle insertion hole,
wherein the joint member comprises a thermally-welded section that is disposed between an inner surface of the tapered hollow portion and an outer surface of the needle at a location separated from a distal end of the distal end connecting section by a predetermined distance toward a proximal end of the distal end connecting section,
wherein the joint member does not include a foamed portion.

### Claim 2 (depends on 1)

The needle-equipped outer tube according to claim 1, wherein both the joint member and the outer tube member are formed of a thermoplastic resin material.

### Claim 3 (depends on 2)

The needle-equipped outer tube according to claim 2, wherein both the joint member and the outer tube member are formed of the same thermoplastic resin material.

### Claim 4 (depends on 3)

The needle-equipped outer tube according to claim 3, both the joint member and the outer tube member are formed of cyclic olefin polymer.

### Claim 5 (depends on 1)

The needle-equipped outer tube according to claim 1, wherein the distal end connecting section has a contact section, which is a non-thermally-welded section that contacts the joint member but is not thermally welded to the joint member, at a location distal of the thermally-welded section, the contact section comprising a residual strain but no crack.

### Claim 6 (depends on 5)

The needle-equipped outer tube according to claim 5, wherein the contact section has a phase difference in birefringence measurement due to the residual strain, and an occurrence frequency of a phase difference exceeding 800 nm in birefringence measurement is equal to or smaller than one tenth of an occurrence frequency of a phase difference smaller than 800 nm.

### Claim 7 (depends on 6)

The needle-equipped outer tube according to claim 6, wherein a phase difference exceeding 900 nm does not occur in birefringence measurement in the contact section.

### Claim 8 (depends on 6)

The needle-equipped outer tube according to claim 6, wherein the contact section has a peak in an occurrence frequency in a range of 100 nm to 500 nm of a phase difference in birefringence measurement.

### Claim 9 (depends on 1)

The needle-equipped outer tube according to claim 1, wherein the thermally-welded section is disposed at a location separated from the proximal end of the distal end connecting section by a predetermined distance toward the distal end of the distal end connecting section.

### Claim 10 (depends on 1)

The needle-equipped outer tube according to claim 1, wherein the joint member comprises a distal end portion having a cylindrical shape, and a proximal end portion comprising the tapered portion.

### Claim 11 (depends on 1)

The needle-equipped outer tube according to claim 1, wherein the needle insertion hole comprises a distal end portion that has a larger diameter than a portion proximal of the distal end portion.
