# US 2017/0283601 A1 · Recycled Resin Compositions And Disposable Medical Devices Made Therefrom

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- Number: US 2017/0283601 A1
- Document ID: US20170283601A1
- Status: Published application
- Kind: A1
- Application number: 15/630,128
- Filed: 2017-06-22
- Published: 2017-10-05
- Earliest claimed: 2010-08-20
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Ankur S. Kulshrestha; Mildred Calistri-Yeh; Lourdes Pia Lopez Amora; Richard Giddes
- Web page: https://patentgrep.com/patent/US20170283601A1

## CPC

- C08L 23/12: Polypropene
- A61L 29/04: Macromolecular materials
- A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions}
- A61L 31/04: Macromolecular materials
- A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- B29C 45/0001: {characterised by the choice of material}
- B29C 48/475: using pistons, accumulators or press rams
- B29K 2023/12: {PP, i.e. polypropylene}
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

Compositions including recycled resin components and medical devices and components made form such compositions are disclosed. The compositions and medical devices are characterized as biocompatible and sterilization stable. In one or more embodiments, the compositions include a recycled resin component and may include one or more of an anti-oxidant component, slip additive component, anti-static component, impact modifier component, colorant component, acid scavenger component, X-ray fluorescence agent component, radio opaque filler component, surface modifier component, melt stabilizer component, clarifier component, processing aid component and reinforcing agent component. Methods of forming medical articles and components are also disclosed.

## Claims

### Claim 1

A method of forming a medical device comprising:
providing a melt blend composition including a 50% to 99% recycled resin component, the melt blend composition having a cytotoxicity score of zero;
stabilizing the composition to withstand exposure to gamma rays, electron beams, X-ray radiations, ethylene oxide gas, autoclave, plasma sterilization; and
solidifying the composition in a pre-selected shape.

### Claim 2 (depends on 1)

The method of claim 1, wherein providing a melt blend composition comprises feeding a recycled resin component and one or more of an antioxidant component, slip additive component, anti-static component, impact modifier component, colorant component, acid scavenger component, nucleating agents, clarifiers, x-ray fluorescence agent component, radio opaque filler component, surface modifier component, processing aid component and reinforcing agent component into a melt compounding extruder.

### Claim 3 (depends on 1)

The method of claim 1, wherein solidifying the composition comprises one of injection molding the composition, extruding the composition, blow molding the composition and rotational molding the composition.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pre-selected shape comprises one of a plunger rod, a syringe barrel, a catheter, a blood collection device, a surgical blade handle, a needle shield, safety shield, catheter wings, catheter flow control plugs and a needle hub, sharps containers, body fluid collection devices, tubing, adapters and drainage tubes.

### Claim 5 (depends on 1)

The method of claim 1, further comprising stabilizing the composition to withstand exposure to gamma rays in the range from about 5 kGys to about 75 kGys.

### Claim 6 (depends on 1)

The method of claim 1, wherein the recycled resin component is biocompatible.

### Claim 7 (depends on 1)

The method of claim 1, wherein the recycled resin component comprises from about 0.1% to about 100% by weight recycled resin selected from one of post-industrial recycled resin, post-consumer recycled resin and combinations thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein the melt blend composition further comprises one or more of a virgin resin component and/or a biobased resin component.

### Claim 9 (depends on 8)

The method of claim 8, wherein the composition of recycled resin composition mechanically mixed with virgin polypropylene resin comprises 60% by weight of recycled resin composition and 40% by weight of the virgin polypropylene resin.

### Claim 10 (depends on 8)

The method of claim 8, wherein the composition of recycled resin composition mechanically mixed with virgin polypropylene resin comprises 70% by weight of recycled resin composition and 30% by weight of the virgin polypropylene resin.

### Claim 11 (depends on 8)

The method of claim 8, wherein the composition of recycled resin composition mechanically mixed with virgin polypropylene resin comprises 50% by weight of recycled resin composition and 50% by weight of the virgin polypropylene resin.

### Claim 12

A composition for molding a medical device comprising:
a recycled resin sourced from a traceable source; and
one or more of an antioxidant component, slip additive component, anti-static component, impact modifier component, colorant component, acid scavenger component, x-ray fluorescence agent component, radio opaque filler component, surface modifier component, processing aid component, melt stabilizer component, clarifier component, nucleating agents and reinforcing agent component,
wherein the composition is biocompatible and has a cytotoxicity score of zero.

### Claim 13 (depends on 12)

The composition of claim 12, wherein the composition is capable of withstanding exposure to gamma rays in the range from about 5 kGys to about 75 kGys.

### Claim 14 (depends on 12)

The composition of claim 12, wherein the composition is capable of withstanding exposure to electron beams in the range from about 30 kGys to about 100 kGys.

### Claim 15 (depends on 12)

The composition of claim 12, wherein the composition is capable of withstanding exposure to one of X-ray radiation, ethylene oxide gas, autoclaving and plasma sterilization.

### Claim 16 (depends on 12)

The composition of claim 12, comprising a flexural modulus in the range from about 70 kpsi to about 350 kpsi.

### Claim 17 (depends on 12)

The composition of claim 12, comprising a melt flow range in the range from about 3 dg/minute to about 80 dg/minute.

### Claim 18 (depends on 12)

The composition of claim 12, comprising a heat deflection temperature from about 60° C. to 260° C.

### Claim 19 (depends on 12)

The composition of claim 12, comprising notched izod impact strength in the range from about 0.1 ft-lb/in to about 4.0 ft-lb/in.

### Claim 20 (depends on 12)

The composition of claim 12, further comprising one or more of a virgin resin component and a biobased resin component.