US-20260124344-A1 - MEDICAL DEVICE WITH SUBSTRATE COMPRISING NATURAL FIBRES

Abstract

A biodegradable urinary catheter for intermittent catheterization includes a substrate comprising at least 30 wt % cellulose fibers, with all components being non-toxic and biodegradable. The substrate is compostable according to standardized protocols, such as ASTM D6400 or EN 13432, and is capable of biodegrading by microorganisms when exposed to environmental conditions, providing an eco-friendly alternative for urinary catheterization.

Inventors

• Asa Rindlav Westling
• Frida ISELAU
• Heikki Sojakka

Assignees

• DENTSPLY IH AB

Dates

Publication Date

20260507

Application Date

20260105

Priority Date

20210225

Claims (20)

1. 1 . A urinary catheter for intermittent catheterization comprising: a substrate comprising at least 30 wt % cellulose fibers; wherein all components of the urinary catheter are biodegradable and non-toxic; wherein the substrate is compostable according to ASTM D6400 or EN 13432; and wherein the substrate is biodegradable by microorganisms under environmental exposure.
2. 2 . The urinary catheter of claim 1 , wherein the substrate is formed from a renewable resource.
3. 3 . The urinary catheter of claim 1 , wherein the substrate is formed of at least 40 wt % cellulose fibers.
4. 4 . The urinary catheter of claim 1 , wherein the substrate is made primarily of paper.
5. 5 . The urinary catheter of claim 1 , wherein the substrate forms a wall enclosing an internal cavity and has a tubular body construction, the wall extending between a proximal insertion end and a distal rearward end.
6. 6 . The urinary catheter of claim 5 , wherein the substrate is formed of multiple layers forming a laminated construction.
7. 7 . The urinary catheter of claim 6 , wherein an internal surface enclosing the internal cavity has been treated with a surface sizing agent.
8. 8 . A urinary catheter comprising: a tubular substrate comprising at least 30 wt % cellulose fibers; a plurality of drainage openings formed in a wall of the tubular substrate adjacent a proximal insertion end; wherein the plurality of drainage openings are formed by one of: punching, cutting, or laser ablation through the tubular substrate.
9. 9 . The urinary catheter of claim 8 , further comprising a separate tip element connected to the tubular substrate, wherein the plurality of drainage openings are positioned in the separate tip element.
10. 10 . The urinary catheter of claim 8 , wherein a central opening at a proximal end serves as a drainage opening.
11. 11 . The urinary catheter of claim 8 , wherein the tubular substrate is formed of multiple layers forming a laminated construction.
12. 12 . The urinary catheter of claim 8 , wherein the tubular substrate has a continuous thermoplastic polymer matrix, and wherein the cellulose fibers distributed throughout the continuous thermoplastic polymer matrix.
13. 13 . The urinary catheter of claim 12 , wherein the continuous thermoplastic polymer matrix is formed of a polylactic acid.
14. 14 . The urinary catheter of claim 8 , wherein the tubular substrate forms a wall enclosing an internal cavity, the wall extending between the proximal insertion end and a distal rearward end, and wherein an internal surface has been treated with a surface sizing agent.
15. 15 . A urinary catheter comprising: a tubular substrate comprising cellulose fibers; wherein an internal surface facing a lumen formed by the tubular substrate has greater water resistance than an external surface; wherein the internal surface has been treated with a surface sizing agent; and wherein the tubular substrate is configured to maintain a structural integrity when urine flows through the lumen for at least 10 minutes.
16. 16 . The urinary catheter of claim 15 , wherein the surface sizing agent comprises starch.
17. 17 . The urinary catheter of claim 15 , wherein a middle portion of the tubular substrate has greater water absorption than the internal surface.
18. 18 . The urinary catheter of claim 15 , wherein the tubular substrate comprises at least 30 wt % cellulose fibers.
19. 19 . The urinary catheter of claim 15 , wherein the tubular substrate is formed of multiple layers forming a laminated construction.
20. 20 . The urinary catheter of claim 15 , further comprising a plurality of drainage openings formed in the tubular substrate near a proximal insertion end thereof.

Description

CROSS REFERENCE TO RELATED APPLICATION(S) This patent document is a continuation of U.S. patent application Ser. No. 17/680,833, filed on Feb. 25, 2022, which claims the benefits and priority of European Patent Application No. 21159364.5, filed on Feb. 25, 2021, each of which is incorporated herein by reference in its entirety. TECHNICAL FIELD The present invention relates to a medical device for insertion into a natural or artificial body opening, such as a urinary or rectal catheter. BACKGROUND Many medical devices incorporate elongate shafts, or similar types of substrates, such as tubes which are intended for insertion into and through passageways of a living body such as those of the urethral tract, the rectal tract and the cardiovascular system. The most common type of this general grouping of medical devices are known as catheters. Example catheters include those designated for urological use, i.e., urinary catheters, and for enterology use, such as rectal catheters. Because of the intended use of such medical devices, certain parameters need to be satisfied by the material from which the substrate/elongate shaft is manufactured. The material must fulfill such requirements as softness, stiffness, good kink resistance, good dimensional stability, processability, for example ease to form and glue, and the possibility to be sterilized by radiation, steam, ethylene oxide or other means. The material must also be able to withstand contact with liquids it is exposed to during use, such as urine. For some products, there is further the need for the material to accept a surface treatment which will impart desired surf ace properties to the medical device, such as hydrophilicity, surface roughness or smoothness, slipperiness, etc. To this latter end, the chemistry of the substrate material is critical since this affects the possibility to coat the substrate. For many years now polyvinyl chloride (PVC) has been used to manufacture medical devices having elongate shafts for insertion into a body passageway, such as catheters, due to PVC fulfilling the requirements mentioned in the preceding paragraph. For instance, EP 0 093 093 by the present applicant makes known a process for manufacturing a PVC urinary catheter having a hydrophilic outer surface coating which exhibits a low coefficient of friction when wetted. However, the suitability of PVC for medical devices such as catheters is now being questioned on environmental grounds and further because of the toxicity of the plasticizers added to PVC. Other substrate materials have also been proposed. For example, WO 97/49437 by the present applicant proposes to use a polyether block amide and a styrene block copolymer as substrate material for a hydrophilic catheter, and U.S. Pat. No. 8,168,249, also by the present applicant, proposes the use of a polyolefin based substrate material. However, a problem with these materials is that these materials are relatively expensive to manufacture. Further, these materials are not from renewable resources or biodegradable. Thus, there is a general problem for most previously known substrates for catheters and similar medical devices that they are costly and/or harmful to the environment, and/or that there are problems related to the hydrophilic coating, such as too poor water retention properties, especially after leaching, too poor adherence to the substrate and too high friction of the hydrophilic surface when wetted. Further, alternatively or additionally, the mechanical properties of the substrates may be inadequate, such as being too stiff or having too high resilience. There is therefore a need for a new substrate material for medical devices, and in particular medical devices to be coated with a hydrophilic surface coating. Specifically, there is a need for medical devices, and substrate thereof, which are environmentally acceptable and cost effective, to which the hydrophilic coating can be adequately adhered, and which have adequate mechanical and chemical properties. In particular, there is a need for medical devices which are more sustainable, and which reduces the carbon footprint. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a medical device, such as a catheter, for insertion into a natural or artificial body opening, which at least alleviates the above-discussed problems. This object is obtained by means of a medical device in accordance with the disclosed embodiments. According to a first aspect of the invention, there is provided a medical device for insertion into a natural or artificial body opening, said medical device comprising a substrate having a wall enclosing an internal cavity, the wall extending between a proximal insertion end and a distal rearward end, wherein said wall comprises at least 30 wt % of natural fibers. Natural fibers are fibers produced naturally in the nature. The natural fibers are preferably at least one of vegetable, bacterial and animal