# US 2020/0399453 A1 · Enhancing Bond Strength Of Medical Devices

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- Number: US 2020/0399453 A1
- Document ID: US20200399453A1
- Status: Published application
- Kind: A1
- Application number: 17/012,927
- Filed: 2020-09-04
- Published: 2020-12-24
- Earliest claimed: 2016-09-26
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Jianbin Zhang; Theresa Hermel-Davidock; Edward Bryan Coughlin; Tea Datashvili
- Web page: https://patentgrep.com/patent/US20200399453A1

## CPC

- C08L 23/06: Polyethylene
- A61L 29/049: {Mixtures of macromolecular compounds}
- F16L 13/007: specially adapted for joining pipes of dissimilar materials {(joints between metal and plastic pipes F16L47/24)}
- C08L 2203/18: used for pipes
- C08L 2207/066: LDPE (radical process)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)
- 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)
- F16L: PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL

## Abstract

Components of medical devices include polyethylene-poly(ethylene oxide) amphiphilic graft copolymers (PE-g-PEO) in their base polymer formulations. The base polymeric formulations comprise at least a polymer or co-polymer of ethylene. These components are suitable for solvent-bonding with other components and enhance bond strength of the medical devices.

## Claims

### Claim 1

A tubing for a medical device formed from a blend comprising:
a base polymeric formulation comprising: polyethylene, polypropylene, or combinations thereof; and a thermoplastic elastomer (TPE) comprising a total polyethylene and/or polypropylene in an amount of at least 60 mol %; wherein the base polymeric formulation excludes free poly(ethylene oxide); and
an additive comprising a polyethylene-poly(ethylene oxide) amphiphilic graft copolymer (PE-g-PEO copolymer), the PE-g-PEO copolymer being effective to enhance solvent bonding of the tubing to a connector.

### Claim 2 (depends on 1)

The tubing of claim 1, wherein the PE-g-PEO copolymer is present in the blend in an amount in the range of 0.01 to 2.5% by weight of the blend.

### Claim 3 (depends on 1)

The tubing of claim 1, wherein the PE-g-PEO copolymer is a product of ethylene oxide ring-opening polymerization of an ethylene vinyl acetate copolymer having from 10 to 40 weight percent of vinyl acetate.

### Claim 4 (depends on 1)

The tubing of claim 1, wherein the PE-g-PEO copolymer is according to Formula (I):
wherein R is hydrogen, alkyl, substituted alkyl, vinylic substituted alkyl, hydrocarbyl, substituted hydrocarbyl, or vinylic substituted hydrocarbyl group; the molar value of m is in the range from 2 to 40 mole percent; the molar value of n is in the range from 60 to 98 mole percent; and p is in the range from 5 to 500 ethylene oxide units.

### Claim 5 (depends on 1)

The tubing of claim 1, wherein the base polymeric formulation consists of the polyethylene and the thermoplastic elastomer (TPE) comprising the total polyethylene and/or polypropylene in the amount of at least 60 mol %.

### Claim 6 (depends on 1)

The tubing of claim 1, wherein the PE-g-PEO copolymer has a dispersity index in the range of 2 to 10.

### Claim 7

A medical device comprising:
a tubing comprising:
a polymeric blend consisting of a base polymeric formulation consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE) comprising a total polyethylene and/or polypropylene in an amount of at least 60 mol %, or combinations thereof, and excluding free poly(ethylene oxide); and
an additive comprising a polyethylene-poly(ethylene oxide) amphiphilic graft copolymer (PE-g-PEO copolymer) according to Formula (I):
wherein R is hydrogen, alkyl, substituted alkyl, vinylic substituted alkyl, hydrocarbyl, substituted hydrocarbyl, or vinylic substituted hydrocarbyl group; the molar value of m is in the range from 2 to 40 mole percent; the molar value of n is in the range from 60 to 98 mole percent; and p is in the range from 5 to 500 ethylene oxide units;
wherein the PE-g-PEO copolymer is present in the blend in an amount in the range of 0.01 to 2.5% by weight of the blend; and
a connector bonded to the tubing;
wherein the PE-g-PEO copolymer is effective to enhance solvent bonding of the tubing to the connector.

### Claim 8 (depends on 7)

The medical device of claim 7, wherein the base polymeric formulation consists of the polyethylene and the thermoplastic elastomer (TPE) comprising the total polyethylene and/or polypropylene in the amount of at least 60 mol %.

### Claim 9 (depends on 7)

The medical device of claim 7, wherein the PE-g-PEO copolymer is a product of ethylene oxide ring-opening polymerization of an ethylene vinyl acetate copolymer having from 10 to 40 weight percent of vinyl acetate.

### Claim 10 (depends on 7)

The medical device of claim 7, wherein the connector comprises a polar material selected from the group consisting of: poly(methyl methacrylate) (PMMA), styrene maleic anhydride (SMA), polycarbonate (PC), and methyl methacrylate-acrylonitrile-butadiene-styrene (MABS).

### Claim 11

A medical tubing manufactured by a process comprising:
melting a polymeric base consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE) comprising a total polyethylene and/or polypropylene in an amount of at least 60 mol %, or combinations thereof, and excluding free poly(ethylene oxide) at a temperature in the range of 60° C. to 300° C. to form a melted polymeric base;
adding an additive comprising a polyethylene-poly(ethylene oxide) amphiphilic graft copolymer (PE-g-PEO copolymer) to the melted polymeric base to form a blend the PE-g-PEO copolymer being present in the blend in an amount in the range of 0.01 to 2.5% by weight of the blend; mixing the blend for a time period in the range of 15 seconds to 90 seconds; and
melt extruding the blend to form the tubing.

### Claim 12 (depends on 11)

The tubing of claim 11, wherein the PE-g-PEO copolymer is according to Formula (I):
wherein R is hydrogen, alkyl, substituted alkyl, vinylic substituted alkyl, hydrocarbyl, substituted hydrocarbyl, or vinylic substituted hydrocarbyl group; the molar value of m is in the range from 2 to 40 mole percent; the molar value of n is in the range from 60 to 98 mole percent; and p is in the range from 5 to 500 ethylene oxide units.

### Claim 13 (depends on 11)

The tubing of claim 11, wherein the base polymeric formulation consists of the polyethylene and the thermoplastic elastomer (TPE) comprising the total polyethylene and/or polypropylene in the amount of at least 60 mol %.

### Claim 14

A method of making a medical device comprising:
obtaining a polyethylene-poly(ethylene oxide) amphiphilic graft copolymer (PE-g-PEO copolymer);
combining the PE-g-PEO copolymer with a base polymeric formulation comprising at least a polymer or co-polymer of ethylene or propylene and excluding free poly(ethylene oxide) to form a blend, the PE-g-PEO copolymer being present in the blend in an amount in the range of about 0.01 to about 5.0% by weight of the blend;
forming a tubing from the blend; and
bonding the tubing to a connector in the presence of a solvent to form the medical device;
wherein the PE-g-PEO copolymer is effective to enhance bonding of the tubing to a connector.

### Claim 15 (depends on 16)

The method of claim 16, wherein ethylene oxide ring-opening polymerization of an ethylene vinyl acetate copolymer having from 10 to 40 weight percent of vinyl acetate is used to form the PE-g-PEO, which is according to Formula (I):
wherein R is hydrogen, alkyl, substituted alkyl, vinylic substituted alkyl, hydrocarbyl, substituted hydrocarbyl, or vinylic substituted hydrocarbyl group; the molar value of m is in the range from 2 to 40 mole percent; the molar value of n is in the range from 60 to 98 mole percent; and p is in the range from 5 to 500 ethylene oxide units.

### Claim 16 (depends on 16)

The method of claim 16, wherein the base polymeric formulation comprises polyethylene, polypropylene, a polyethylene-polypropylene co-polymer, a polyethylene- and/or polypropylene-containing thermoplastic elastomer (TPE), or combinations thereof.

### Claim 17 (depends on 16)

The method of claim 16, wherein the base polymeric formulation comprises a co-polymer of polyethylene and polypropylene.

### Claim 18 (depends on 16)

The method of claim 16, wherein the polyethylene- and/or polypropylene-containing thermoplastic elastomer (TPE) comprises at least 60 mol % polyethylene and/or polypropylene.

### Claim 19 (depends on 16)

The method of claim 16, wherein the base polymeric formulation consists of the polyethylene and the thermoplastic elastomer (TPE) comprising the total polyethylene and/or polypropylene in the amount of at least 60 mol %, and the PE-g-PEO copolymer is present in the blend in an amount in the range of 0.01 to 2.5% by weight of the blend.

### Claim 20 (depends on 16)

The method of claim 16, wherein:
combining the PE-g-PEO copolymer with the base polymeric formulation comprises: melting the base polymeric formulation at a temperature in the range of 60° C. to 300° C. to form a melted polymeric base and mixing the blend for a time period in the range of 15 seconds to 90 seconds; and
forming the tubing comprises melt extruding the blend.
