Enhancing bond strength of medical devices

Patent metadata

Field	Value
Publication number	US-11649343-B2
Application number	US-202017012932-A
Country	US
Kind code	B2
Filing date	Sep 4, 2020
Priority date	Sep 26, 2016
Publication date	May 16, 2023
Grant date	May 16, 2023

Abstract

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

First claim

What is claimed is:

1. A tubing for a medical device formed from a blend comprising:
a base polymeric formulation comprising: from 10% to 50% by weight of a polyethylene homopolymer; and a thermoplastic elastomer (TPE) comprising a copolymer of polypropylene monomeric units with other monomeric units; wherein the base polymeric formulation excludes free poly(ethylene oxide); and
an additive comprising a polypropylene-poly(ethylene oxide) amphiphilic graft copolymer (PP-g-PEO copolymer), the PP-g-PEO copolymer being effective to enhance solvent bonding of the tubing to a connector;
wherein the other monomeric units of the thermoplastic elastomer (TPE) comprise ethylene and butylene monomeric units, wherein a total of propylene, ethylene, and butylene monomeric units is 100 mol %.

2. The tubing of claim 1 , wherein the PP-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.

3. The tubing of claim 1 , wherein the PP-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 percentages of grafted maleic anhydride units, m, is in the range from 2 to 10 mole percent; the molar values of propylene units, n, is in the range from 98 to 90 mole percent, and p is in the range of 5 to 500 ethylene oxide units.

4. The tubing of claim 1 , wherein the thermoplastic elastomer (TPE) comprises ethylene and propylene monomeric units in a total amount of at least 57 mol %.

5. A medical device comprising:
the tubing of claim 1 ; and
a connector bonded to the tubing;
wherein the PP-g-PEO copolymer is effective to enhance solvent bonding of the tubing to the connector.

6. The medical device of claim 5 , wherein the thermoplastic elastomer (TPE) comprises ethylene and propylene monomeric units in a total amount of at least 57 mol %.

7. The medical device of claim 5 , wherein the PP-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 percentages of grafted maleic anhydride units, m, is in the range from 2 to 10 mole percent; the molar values of propylene units, n, is in the range from 98 to 90 mole percent, and p is in the range of 5 to 500 ethylene oxide units.

8. The medical device of claim 5 , 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).

9. A medical tubing manufactured by a process comprising:
melting a polymeric base comprising: from 10% to 50% by weight of a polyethylene homopolymer; a thermoplastic elastomer (TPE) comprising a copolymer of propylene monomeric units with other monomeric units, the other monomeric units of the thermoplastic elastomer (TPE) comprising ethylene and butylene monomeric units, wherein a total of propylene, ethylene, and butylene monomeric units is 100 mol %; 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 polypropylene-poly(ethylene oxide) amphiphilic graft copolymer (PP-g-PEO copolymer) to the melted polymeric base to form a blend the PP-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.

10. The medical tubing of claim 9 , wherein the PP-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 percentages of grafted maleic anhydride units, m, is in the range from 2 to 10 mole percent; the molar values of propylene units, n, is in the range from 98 to 90 mole percent, and p is in the range of 5 to 500 ethylene oxide units.

11. The medical tubing of claim 9 , wherein the thermoplastic elastomer (TPE) comprises ethylene and propylene monomeric units in a total amount of at least 57 mol %.

12. A method of making a medical device comprising:
obtaining a polypropylene-poly(ethylene oxide) amphiphilic graft copolymer (PP-g-PEO);
combining the PP-g-PEO with a base polymeric formulation comprising: from 10% to 50% by weight of a polyethylene homopolymer; and a thermoplastic elastomer (TPE) comprising a copolymer of polypropylene monomeric units with other monomeric units, the other monomeric units of the thermoplastic elastomer (TPE) comprising ethylene and butylene monomeric units, wherein a total of propylene, ethylene, and butylene monomeric units is 100 mol %, and excluding free poly(ethylene oxide) to form a blend, the PP-g-PEO 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;
bonding the tubing to a connector in the presence of a solvent to form the medical device;
wherein the PP-g-PEO is effective to enhance bonding of the tubing to a connector.

13. The method of claim 12 , wherein ethylene oxide ring-opening polymerization of a polypropylene-maleic anhydride co-polymer (PP-MA) having from 10-50 weight percent of maleic anhydride is used to form the PP-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 percentages of grafted maleic anhydride units, m, is in the range from 2 to 10 mole percent; the molar values of propylene units, n, is in the range from 98 to 90 mole percent, and p is in the range of 5 to 500 ethylene oxide units.

14. The method of claim 12 , wherein the thermoplastic elastomer (TPE) comprises ethylene and propylene monomeric units in a total amount of at least 57 mol %.

15. The method of claim 12 , wherein the thermoplastic elastomer (TPE) comprises ethylene, propylene, butylene monomeric units in an amount of 100 mol %, and the PP-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.

16. The method of claim 12 , wherein:
combining the PP-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.

Assignees

• Becton Dickinson Co

Inventors

• Zhang Jianbin
• Hermel-Davidock Theresa
• Coughlin Edward Bryan
• Datashvili Tea

Classifications

• C08L23/20 Primary

  having four to nine carbon atoms · CPC title

• C08L23/12

  Polypropene · CPC title

• A61L27/16 Primary

  obtained by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• C08L2203/18

  used for pipes · CPC title

• F16L13/103

  Adhesive joints · CPC title