# US 11,027,060 B2 · Flexible tubing, cannula and insertion needle

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- Number: US 11,027,060 B2
- Document ID: US11027060B2
- Status: Granted
- Kind: B2
- Application number: 15/973,465
- Filed: 2018-05-07
- Published: 2018-11-08
- Granted: 2021-06-08
- Earliest claimed: 2017-05-08
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic MiniMed, Inc.
- Inventors: Chia-Hung Chiu; Hsifu Wang; Rebecca K. Gottlieb
- Web page: https://patentgrep.com/patent/US11027060B2

## CPC

- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds}
- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/14248: {of the skin patch type}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0043: {characterised by structural features}
- A61M 39/02: Access sites
- A61M 39/08: Tubes; Storage means specially adapted therefor
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 2017/3454: {Details of tips}
- A61M 25/065: {Guide needles}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking}
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A flexible, fluid flow tubing is configured to be kink resistant, and a medical device is configured with such kink resistant tubing. The tubing has a length L and a circular cross-section shape taken perpendicular to the length dimension. The tubing has an inside radius r and an outside radius R, wherein L/R≥34.8, and wherein R/r≥1.5. The tubing may be made of a polyether block amide (PEBA) or other thermoplastic elastomer (TPE). The tubing may be received in a channel of a hollow needle, wherein the needle is slideable in the axial dimension relative to the tubing, to selectively slide off of at least a portion of the tubing.

## Claims

### Claim 1

A medical device comprising a fluid flow tubing configured to resist kinking, the tubing having a length L extending along an axial dimension of the tubing, the tubing having a fluid flow passage, a needle having a channel extending from a distal end of the needle along at least a portion of an axial length dimension of the needle, and a base, wherein the fluid flow tubing is located at least partially within the channel of the needle, wherein the needle has a side slot extending along a generally linear section of the needle in a direction of the axial length dimension of the needle and open to the channel, wherein a portion of the fluid flow tubing including a portion of the fluid flow passage extends out of the channel through the side slot, the fluid flow tubing having a distal end located within the channel of the needle and a second end located outside of the channel of the needle, the needle being slideable in the axial dimension relative to the fluid flow tubing, to selectively slide off of the distal end of the fluid flow tubing, wherein at least some of the portion of the fluid flow tubing extending outside of the channel is held by the base in a fixed position relative to distal end of the fluid flow tubing to inhibit movement of the tubing with the needle as the needle is slid off of the distal end of the fluid flow tubing, and wherein the entire portion of the fluid flow tubing located outside of the channel is contained in the base, in a fixed position relative to the distal end of the fluid flow tubing.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the tubing has an inside radius r and an outside radius R, and wherein R/r is equal to or greater than 1.5.

### Claim 3 (depends on 1)

The medical device of claim 1, wherein the tubing has a length L and an outside radius R, and wherein L/R is within the range of 34.889 to 78.667.

### Claim 4 (depends on 1)

The medical device of claim 1, wherein the tubing is made of a polyether block amide (PEBA) or other thermoplastic elastomer (TPE).

### Claim 5 (depends on 1)

The medical device of claim 1, wherein the fluid flow tubing has a first section including a first portion of the fluid flow passage that is located in the channel of a hollow needle, a second section including a second portion of the fluid flow passage located outside of the channel of the hollow needle, and a further section including the portion of the fluid flow passage that extends through the side slot of the hollow needle, the further section connecting the first portion of the fluid flow passage with the second portion of the fluid flow passage.

### Claim 6 (depends on 1)

The medical device of claim 1, wherein: the fluid flow tubing including the portion of the fluid flow passage extends through the side slot of the needle as the needle is slid at least partially off of the fluid flow tubing; and the slot extends from a distal end of the needle, along at least a portion of the axial length dimension of the needle.

### Claim 7 (depends on 1)

The medical device of claim 1, wherein the slot extends from the distal end of the needle, along the entire axial length dimension of the needle.

### Claim 8 (depends on 1)

The medical device of claim 1, wherein the needle has a “C” shaped cross-section shape taken perpendicular to the axial length dimension of the needle.

### Claim 9 (depends on 1)

The medical device of claim 1, wherein the side slot in the needle has a first width along a first section of the axial length dimension of the needle and a second width along a second section of the axial length dimension of the needle, the first width being different than the second width.

### Claim 10 (depends on 1)

The medical device of claim 1, wherein the base has at least one of a surface configured to abut and be secured to a patient's skin, and a mechanism for securing the base externally to a patient's skin.

### Claim 11 (depends on 1)

The medical device of claim 1, wherein the needle has a circular cross-section shape taken perpendicular to the length dimension, the tubing having a fluid flow passage along the length L, an inside radius r and an outside radius R, wherein L/R is equal to or greater than 34.8.

### Claim 12 (depends on 11)

The medical device of claim 11, wherein: L/R is within the range of 34.889 to 78.667; and R/r is equal to or greater than 1.5.

### Claim 13 (depends on 12)

The medical device of claim 12, wherein the tubing is made of a polyether block amide (PEBA) or other thermoplastic elastomer (TPE).

### Claim 14

A method of making a medical device comprising:
providing a kink resistant fluid flow tubing having a length L extending along an axial dimension of the tubing and a fluid flow passage along the length L;
receiving a first portion of the fluid flow tubing within a channel in a needle, the channel extending from a distal end of the needle along at least a portion of a length of the needle, wherein the needle has a side slot extending along a generally linear section of the needle in a direction of the length of the needle and open to the channel; and
extending a second portion of the fluid flow tubing including a portion of the fluid flow passage out of the channel and through the side slot of the needle;
wherein the needle is slideable in the axial dimension relative to the fluid flow tubing, to selectively slide off of at least a distal end portion of the fluid flow tubing;
wherein the method further comprises holding at least some of the second portion of the fluid flow tubing in a fixed position relative to the distal end portion of the fluid flow tubing to inhibit movement of the fluid flow tubing with the needle when the needle is slid off of the distal end portion of the fluid flow tubing; and
wherein the entire portion of the fluid flow tubing located outside of the channel is held in the base, in a fixed position relative to the distal end of the fluid flow tubing.

### Claim 15 (depends on 14)

The method of claim 14, wherein the fluid flow tubing has an outside radius R, and wherein L/R is equal to or greater than 34.8.

### Claim 16 (depends on 15)

The method of claim 15, wherein the fluid flow tubing has an inside radius r, and wherein R/r is equal to or greater than 1.5.

### Claim 17 (depends on 16)

The method of claim 16, wherein providing the kink resistant fluid flow tubing comprises forming the tubing of polyether block amide (PEBA) or other thermoplastic elastomer (TPE).

### Claim 18 (depends on 14)

The method of claim 14, wherein the fluid flow tubing has an outside radius R, and wherein L/R is within the range of 34.889 to 78.667.

### Claim 19 (depends on 14)

The method of claim 14, wherein providing the kink resistant fluid flow tubing comprises forming a tubing of polyether block amide (PEBA) or other thermoplastic elastomer (TPE).

### Claim 20 (depends on 14)

The method of claim 14, further comprising providing the base has at least one mechanism for securing the base externally to a patient's skin.

### Claim 21

A medical device comprising:
a hollow needle having a central channel, a side slot extending along a generally linear section of the needle in a length dimension of the needle and open to the channel, a distal end and an opening at the distal end;
a fluid flow tubing configured to resist kinking, the tubing having a length L extending along an axial dimension of the tubing, and a circular cross-section shape taken perpendicular to the length dimension, the tubing having a fluid flow passage along the length L and an outside radius R, wherein L/R is equal to or greater than 34.8, the tubing having a distal end and a length portion located within the central channel of the hollow needle, the fluid flow tubing having a portion including a portion of the fluid flow passage that extends out of the channel through the side slot of the needle; and
a base;
wherein the needle is slideable in the axial dimension relative to the tubing, to selectively slide off of at least the distal end of the tubing, and cause the distal end of the tubing to exit the channel through the opening at the distal end of the needle as the needle is slid at least partially off of the tubing, while the portion of the fluid flow tubing including the portion of the fluid flow passage extends out of the channel through the side slot of the needle;
wherein at least a portion of the fluid flow tubing outside of the channel of the needle is held by the base in a fixed position relative to the distal end of the fluid flow tubing to inhibit movement of the fluid flow tubing with the needle as the needle is slid off of the distal end of the fluid flow tubing; and wherein the entire portion of the fluid flow tubing located outside of the channel is contained in the base, in a fixed position relative to the distal end of the fluid flow tubing.

### Claim 22

A medical device comprising a fluid flow tubing configured to resist kinking, the tubing having a length L extending along an axial dimension of the tubing, the tubing having a fluid flow passage, a needle having a channel extending from a distal end of the needle along at least a portion of an axial length dimension of the needle, and a base, wherein the fluid flow tubing is located at least partially within the channel of the needle, wherein the needle has a side slot extending along a generally linear section of the needle in a direction of the axial length dimension of the needle and open to the channel, wherein a portion of the fluid flow tubing including a portion of the fluid flow passage extends out of the channel through the side slot, the fluid flow tubing having a distal end located within the channel of the needle and a second end located outside of the channel of the needle, the needle being slideable in the axial dimension relative to the fluid flow tubing, to selectively slide off of the distal end of the fluid flow tubing, wherein at least some of the portion of the fluid flow tubing extending outside of the channel is held by the base in a fixed position relative to distal end of the fluid flow tubing to inhibit movement of the tubing with the needle as the needle is slid off of the distal end of the fluid flow tubing, and wherein the portion of the fluid flow tubing extending outside of the channel is held by the base in a fixed bend of between about 90° and about 160°.