JP-2026514341-A - Low-absorption multilayer medical tubing

Abstract

Medical tubing can have a continuous inner layer with a continuous outer layer on the surface, the inner layer containing polyethylene, polypropylene, or a polyolefin such as a functionalized polyolefin. The outer layer can contain a thermoplastic polymer such as one or more of thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), styrene-based block copolymer (SBC), or a mixture containing these. Advantageously, the outer and/or inner layers do not contain polyvinyl chloride. Such tubing material can be readily solvent-bonded to medical connectors and used with infusion sets.

Inventors

• セヴィンチ、ゼフラ
• トレーナー、ローレンス ジェイ．
• スウィト、ワンティジナルジョ
• ドーアン、マーク
• ゲバラ、アンソニー チャールズ

Assignees

• ケアフュージョン ３０３、インコーポレイテッド

Dates

Publication Date

20260511

Application Date

20240314

Priority Date

20230331

Claims (19)

1. A medical tube material having a continuous inner layer having a continuous outer layer on its surface, The inner layer contains polyolefin, The outer layer comprises a thermoplastic polymer selected from thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene-based block copolymer (SBC). The medical tube material is a medical tube material having at least 25% higher adhesive strength than a medical tube composed of a single layer of the thermoplastic polymer.
2. The medical tube material according to claim 1, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.
3. The medical tubing material according to claim 2, wherein the polyolefin is made of polyethylene or polypropylene.
4. The medical tubing material according to claim 2, wherein the polyolefin comprises maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, or a combination thereof.
5. The medical tubing material according to claim 2, wherein the thermoplastic polymer is made of thermoplastic urethane.
6. The medical tubing material according to any one of claims 1 to 5, wherein the thermoplastic polymer is one or more of styrene-containing thermoplastic elastomers (S-TPE), polyolefin elastomers (POE), styrene-based block copolymers (SBC), or a mixture thereof.
7. The medical tubing material according to any one of claims 1 to 6, wherein the outer layer and the inner layer do not contain polyvinyl chloride.
8. The medical tubing material according to any one of claims 1 to 7, wherein the inner layer is in direct contact with the outer layer.
9. The medical tubing material is the medical tubing material according to any one of claims 1 to 8, wherein the Shore A hardness is less than approximately 65.
10. An infusion set comprising the medical tubing material described in any one of claims 1 to 9, bonded to a medical connector by solvent adhesive.
11. The infusion set according to claim 10, wherein the medical connector comprises an acrylic-based polymer, and the medical tubing material is bonded to the acrylic-based polymer.
12. The intravenous fluid set according to claim 10, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.
13. The infusion set according to any one of claims 10 to 12, wherein the polyolefin is made of polyethylene or polypropylene, and the thermoplastic polymer is made of thermoplastic urethane.
14. A method for preparing an infusion set comprising the medical tubing material described in any one of claims 1 to 9, A thin layer of solvent is applied to one or both of the surfaces of the medical tubing material and the medical connector, and A method comprising, after applying the thin layer of the solvent, holding together the surface of the medical tube material and the surface of the medical connector until a seal is formed between them.
15. The method according to claim 14, wherein the solvent is applied to the outer layer of the tube material as the surface of the tube material.
16. The method according to claim 14 or 15, wherein the medical connector comprises an acrylic-based polymer.
17. The method according to any one of claims 14 to 16, wherein the solvent comprises one or more alcohols, glycols, ketones, esters such as ethyl acetate, amides, sulfoxides, or hydrocarbons.
18. The method according to any one of claims 14 to 17, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.
19. The method according to claim 18, wherein the polyolefin is made of polyethylene or polypropylene.

Description

This disclosure generally relates to tubing materials, and more particularly to flexible medical tubing materials that absorb little medical fluid and components of such fluids, but can be easily bonded to other medical components by solvent bonding. Such tubing materials can be used in medical devices, such as tubing materials for administering medical fluids by injection. Plastic tubing is widely used in the medical field, specifically for patient diagnosis and treatment procedures. However, medical tubing requires a variety of sometimes incompatible requirements. For example, medical tubing should be strong yet flexible or bendable, resistant to twisting, resistant to reaction with fluids, and prevent the introduction of undesirable chemicals into the fluid being transported through it. However, many plastic materials with such properties are inflexible. Many plastic materials with such properties are inert, making it difficult to bond such tubing with solvents. However, in many applications, medical tubing is used with infusion pumps that move fluid through the tubing by pinching, squeezing, or pressurizing the tubing. In such applications, the tubing needs to be flexible, easy to pinch, and quickly recover its shape. Flexible tubing materials such as polyvinyl chloride containing plasticizers have been used in infusion sets for many years. Unfortunately, plasticized polymer materials such as plasticized polyvinyl chloride can be sticky, potentially causing blockages and ruptures in tubing. Therefore, there continues to be a demand for medical tubing materials that can address the diverse requirements of various medical applications. This is a diagram of an exemplary medical tube having a continuous inner layer and a continuous outer layer according to an aspect of the present disclosure.This is a diagram of another exemplary medical tube according to an aspect of the present disclosure, comprising a continuous inner layer, a continuous outer layer on the surface of the inner layer, and a bonding layer between the continuous inner layer and the continuous outer layer.This is a diagram of a multi-material polyolefin backing layer for medical use, which includes a continuous polyolefin inner layer, a continuous outer layer, and a solvent-bondable, intermittent compartmental layer in direct contact with the outer layer.This is a bar graph showing the maximum load (in Newtons) required to break a medical tubing material connected to a medical connector. The graph compares a medical tubing material (control group) consisting of a single layer of polymer material ("mono") with a medical tubing material having a thermoplastic polymer with a polyolefin backing layer, and further compares such tubing materials with medical tubing materials manufactured by alternative extrusion technology (AET).This figure shows how several variables affect the extrusion molding of medical tubing materials.This figure shows the effect of adjusting several variables during extrusion molding on the resulting adhesion strength. The detailed description below describes various configurations of the patented technology and is not intended to represent only the configurations in which the patented technology can be implemented. The detailed description includes specific details necessary for a complete understanding of the patented technology. Therefore, dimensions are given as non-limiting examples in some embodiments. However, it will be apparent to those skilled in the art that the patented technology can be implemented even without these specific details. In some cases, well-known structures and components are shown in block diagrams to avoid obscuring the concept of the patented technology. This disclosure includes examples of the patentable technology, but should be understood not to limit the scope of the attached claims. Various aspects of the patentable technology are disclosed below by specific but non-limiting examples. The various embodiments described in this disclosure may be carried out in different ways and variations according to the desired application or practice. The patented aspect of the technology relates to medical tubing materials that can meet the requirements of different properties. To overcome the technical challenges arising from conflicting design requirements for medical tubing materials, advanced material formulations and structures are necessary for such tubing materials. For example, medical tubing materials should be able to be bonded to joints and other components for connecting tubing materials by solvent bonding, for example, because solvent bonding is relatively easy, convenient, and cost-effective. Furthermore, medical tubing materials should simultaneously be resistant to absorption by medical fluids and their components without significantly altering the tubing material itself or any active pharmaceutical ingredient (API). This requires the material to be inert for drug compatibility and solve