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WO2025080272A1 - Re-usable bronchoscope coated with antimicrobial hydrophilic coating - Google Patents

Re-usable bronchoscope coated with antimicrobial hydrophilic coating Download PDF

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Publication number
WO2025080272A1
WO2025080272A1 PCT/US2023/076831 US2023076831W WO2025080272A1 WO 2025080272 A1 WO2025080272 A1 WO 2025080272A1 US 2023076831 W US2023076831 W US 2023076831W WO 2025080272 A1 WO2025080272 A1 WO 2025080272A1
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WIPO (PCT)
Prior art keywords
tich
coating layer
exterior coating
base material
aspects
Prior art date
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Pending
Application number
PCT/US2023/076831
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French (fr)
Inventor
Matthew CARTRIGHT
Genevieve MESSINA
William E. Parmentier
Kyra TEMPLE
Summer L. FORD
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Bard Peripheral Vascular Inc
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Bard Peripheral Vascular Inc
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Priority to PCT/US2023/076831 priority Critical patent/WO2025080272A1/en
Publication of WO2025080272A1 publication Critical patent/WO2025080272A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/12Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/12Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/04Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/08Coatings comprising two or more layers

Definitions

  • a 2 nd aspect of the present disclosure concerns the exterior coating layer of the 1 st aspect, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
  • PTFE polytetrfluoroethylene
  • ePTFE expanded polytetrafluoroethylene
  • E-CTFE chlorotrifluoroethylene
  • PFA perfluoroalkoxy
  • ETFE ethylene tetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • a 6 th aspect of the present disclosure concerns an exterior coating layer covering at least a part of a working length of a bronchoscope, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh) composite
  • TiCh titanium-dioxide
  • a 7 th aspect of the present disclosure concerns the exterior coating layer of the 6 th aspect, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE.
  • a 13 th aspect of the present disclosure concerns the exterior coating layer of the 12 th aspect, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
  • the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
  • a 22 nd aspect of the present disclosure concerns the endobronchial device of the 21 st aspect, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
  • the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
  • a 23 rd aspect of the present disclosure concerns an endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh) composite.
  • TiCh titanium-dioxide
  • a 24 th aspect of the present disclosure concerns the endobronchial device of the 23 rd aspect, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE.
  • FIG. 2 shows an aspect of the present disclosure wherein a TiCh composite overlays the base material on the substrate of the exterior surface of an endoscopic device.
  • TiCh is present as nanoparticles dispersed throughout a baser material of the exterior coating layer. In some aspects, the TiCh is bound and/or entangled and/or cross-linked with the base material.
  • the exterior coating layer may include polytetrafluoroethylene (PTFE) as the base material or substrate of the exterior coating layer.
  • PTFE polytetrafluoroethylene
  • other materials can be substituted and/or combined with PTFE as the base material of the exterior coating layer.
  • ePTFE expanded polytetrafluoroethylene
  • E-CTFE chlorotrifluoroethylene
  • PFA perfluoroalkoxy
  • ETFE ethylene tetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • the base material provides a hydrophilic material with low coefficient of friction that assists in maneuvering the working length through the airways of a subject.
  • the present disclosure concerns an exterior coating layer that is a antimicrobial hydrophilic coating that is applied to the working length of the device (insertion tube) that comes into contact with the patients airways.
  • the exterior coating layer is a composite coating of TiCh and PTFE/ePTFE/ETFE/FEP/PFA. E-CTFE.
  • the composite coating reduces surface friction, increase lubricity, provide antimicrobial and anticorrosive properties; which would allow the coating to reduce the bacterial build-up between patients and reduce the risk of transmitted infection.
  • the hydrophilic aspect of the coating is expected to improve the reprocessing ability of the device in comparison to the uncoated prior art.
  • the exterior coating layer is a composite of TiCh and ePTFE.
  • the TiCh is embedded within the ePTFE or deposited thereon.
  • the TiCh is bound and/or embedded and/or cross-linked with the ePTFE.
  • the ePTFE base material is first applied to the working length and then the TiCh.
  • the ePTFE may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto.
  • the ePTFE may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind.
  • TiCh and/or ePTFE nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon.
  • the exterior of the working length may be pre-treated or precoated with one or more intermediary layers to increase the adhesion of the base material to the exterior of the working length.
  • Such may include an adhesive coating and/or plasma pretreatment to generate radical with which the base material can more strongly interact.
  • the intermediary coating may be of the base material as described herein.
  • FIG. 2 shows view wherein a TiCh composite overlays the base material on the substrate of the exterior surface of an endoscopic device.
  • the exterior coating layer is applied to the exterior surface of the working length of a bronchoscope and/or on a coating preapplied thereon.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials For Medical Uses (AREA)
  • Laminated Bodies (AREA)

Abstract

The present disclosure concerns coatings for re-usable bronchoscopes that increase dry lubrication while also providing a bactericidal quality to allow for increased hygienic re-use. In aspects, the present disclosure concerns a titanium dioxide-polytetrafluoroethylene composite coating along the working length of the bronchoscope.

Description

Re-usable bronchoscope coated with antimicrobial hydrophilic coating
BACKGROUND
[0001] Bronchoscopes are utilized to provide a thin tube through the nose or mouth and along the throat to allow a user to view into the lungs of a subject. Largely, bronchoscopes are prepared as single use out of sanitary concerns. Current reusable bronchoscopes do not have any device coating and are susceptible to contamination even when appropriate cleaning/disinfection/reprocessing guidelines are followed. Hence there lies a need for a sustainable re-usable bronchoscope that meets sanitary and health concerns while also not contributing to needless solid-waste.
SUMMARY
[0002] A 1st aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns an exterior coating layer covering at least a part of a working length of a bronchoscope, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh).
[0003] A 2nd aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 1st aspect, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
[0004] A 3rd aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 1st or 2nd aspect, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
[0005] A 4th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 1st, 2nd, or 3rd aspect, wherein TiCh is present as a nanoparticle.
[0006] A 5th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 4th aspect, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
[0007] A 6th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns an exterior coating layer covering at least a part of a working length of a bronchoscope, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh) composite [0008] A 7th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 6th aspect, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE. [0009] An 8th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 6th or 7th aspect, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
[0010] A 9th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 6th, 7th, or 8th aspect, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
[0011] A 10th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 6th, 7th, 8th, or 9th aspect, wherein TiCh is present as a nanoparticle.
[0012] An 11th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 10th aspect, wherein the nanoparticle has a mean width of 0. 1 nm to 100 nm.
[0013] A 12th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 1st or 6th aspect, wherein the base material further comprises a nonionic surfactant.
[0014] A 13th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the exterior coating layer of the 12th aspect, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
[0015] A 14th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns a method for assessing the airways of a subject comprising provding a bronchoscope through the mouth or nose of a subject, wherein a working length of the bronchoscope comprises the exterior coating layer of any of the 1st through 13th aspects. [0016] A 15th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns an endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer of any of the 1st through 13th aspects.
[0017] A 16th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns an endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh)
[0018] A 17th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 16th aspect, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
[0019] A 18th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 16th or 17th aspect, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
[0020] A 19th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 16th, 17th, or 18th aspect, wherein TiCh is present as a nanoparticle.
[0021] A 20th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 19th aspect, wherein the nanoparticle has a mean width of 0. 1 nm to 100 nm.
[0022] A 21st aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 16th aspect, wherein the base material further comprises a nonionic surfactant.
[0023] A 22nd aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 21st aspect, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
[0024] A 23rd aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns an endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh) composite.
[0025] A 24th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 23rd aspect, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE. [0026] A 25th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 123rd or 24th aspect, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
[0027] A 26th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 23rd, 24th, or 25th aspect, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
[0028] A 27th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 23rd, 24th, 25th, or 26th aspect, wherein TiCh is present as a nanoparticle.
[0029] A 28th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 27th aspect, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
[0030] A 29th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 23rd aspect, wherein the base material further comprises a nonionic surfactant.
[0031] A 24th aspect of the present disclosure, either alone or in combination with any other aspect herein, concerns the endobronchial device of the 29th aspect, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] It is to be understood that both the foregoing general description and the following detailed description describe various aspects and are intended to provide an overview or framework for understanding the nature and character of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various aspects, and are incorporated into and constitute a part of this specification. The drawings illustrate the various aspects described herein, and together with the description serve to explain the principles and operations of the claimed subject matter.
[0033] FIG. 1 is a schematic of a bronchoscope. The dashed box shows the region thereon wherein the exterior coating layer of the present disclosure is applied. A cross- sectional view of the end of the working length is depicted in the inset.
[0034] FIG. 2 shows an aspect of the present disclosure wherein a TiCh composite overlays the base material on the substrate of the exterior surface of an endoscopic device.
DESCRIPTION
[0035] The present disclosure concerns a coating along the working length of a bronchoscope. FIG. 1 depicts a schematic of a bronchoscope with the parts labelled therein. As shown in FIG. 1, the bronchoscope includes a working channel and a working length that actively are inserted into the subject’s mouth or nose. The end of the working length includes a CCD/lens (or similar imaging device) and a light source to allow for images captured to be illuminated and visible. The inside of the working length operably connects the CCD/lens and light source to controls therefor. The outside of the working length is typically a rubber or similar flexible material to allow for maneuvering through airways without causing injury. [0036] The present disclosure concerns an exterior coating along the working length of the bronchoscope, as well as potentially over all or part of the working channel. The exterior coating includes titanium dioxide (TiCh) deposited or linked therein. TiCh possesses photocatalytic properties that can help to decompose organic materials. TiCh is a broadspectrum bactericide with high biocompatibility to human subjects. In some aspects, TiCh allows for the generation of reactive oxygen species from water and/or dioxide molecules.
[0037] In some aspects, TiCh is present as nanoparticles dispersed throughout a baser material of the exterior coating layer. In some aspects, the TiCh is bound and/or entangled and/or cross-linked with the base material.
[0038] In some aspects, the exterior coating layer may include TiCh at a concentration of about 0.01 to 10 pg/mm2. In certain aspects, the TiCh or TiCh nanoparticle is provided on the device in the polymer coating at a density of from about 0.01 to about 1 pg/mm2 or about 0.1 to about 10 pg/mm2 or about 0.5 to about 5 pg/mm2 or about 0.05 to about 5 pg/mm2. In some aspects, the dose density of the TiCh in the coating can vary from about 0.1 to about 10 pg/mm2, including about 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, .1, 2.8., 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7,
4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8,
6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9,
9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, and 9.9 pg/mm2.
[0039] In some aspects, the TiCh is present as a nanoparticle deposited on and/or within the base material of the exterior coating layer. In aspects, the TiCh nanoparticle is of from about 0.1 nm to about 100 nm, including about 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 99 nm and any size or number therein.
[0040] In some aspects, the exterior coating layer may include polytetrafluoroethylene (PTFE) as the base material or substrate of the exterior coating layer. It will be appreciated that other materials can be substituted and/or combined with PTFE as the base material of the exterior coating layer. For example, expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP). The base material provides a hydrophilic material with low coefficient of friction that assists in maneuvering the working length through the airways of a subject. Similarly, the base material provides a dry lubricant coating along the working length of the bronchoscope. It will also be appreciated that the base material can also be a metal, such as stainless steel. In aspects, it will also be appreciated that when the base material is a metal, the degree of flexibility is significantly impacted.
[0041] In aspects, the present disclosure concerns an exterior coating layer that is a antimicrobial hydrophilic coating that is applied to the working length of the device (insertion tube) that comes into contact with the patients airways. In aspects, the exterior coating layer is a composite coating of TiCh and PTFE/ePTFE/ETFE/FEP/PFA. E-CTFE. The composite coating reduces surface friction, increase lubricity, provide antimicrobial and anticorrosive properties; which would allow the coating to reduce the bacterial build-up between patients and reduce the risk of transmitted infection. In addition, the hydrophilic aspect of the coating is expected to improve the reprocessing ability of the device in comparison to the uncoated prior art.
[0042] In aspects, the exterior coating layer is provided as a sprayed or dip-coated layer along the working length of the bronchoscope. Methods of applying the coating may include dip coating, metering coating, spray coating, electrostatic spray coating, roller coating, spin coating, ink-jet printing, 3D printing, or combinations thereof. In some aspects, TiCh is prepared in a solution with PTFE/ePTFE/ETFE/FEP/PFA/E-CTFE or a combination thereof dissolved therein. As the solvent evaporates, the base material and TiCh remain on the exterior surface of the working length. It will be appreciated that such coatings may be applied 2, 3, 4, or more times until the base material and/or TiCh is at a desired concentration and/or thickness on the working length.
[0043] In aspects, the exterior coating layer is a composite of TiCh and PTFE. In some aspects, the TiCh is embedded within the PTFE or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the PTFE. In some aspects, the PTFE base material is first applied to the working length and then the TiCh. In some aspects, the PTFE may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the PTFE may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, a sub-layer, such as polydopamine, can be provided between the base material and the coating layer. In some aspects, TiCh and/or PTFE nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon (see, e.g., Zhang et al. App. Surface Sci. 490: 231-241, 2019)
[0044] In aspects, the exterior coating layer is a composite of TiCh and ePTFE. In some aspects, the TiCh is embedded within the ePTFE or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the ePTFE. In some aspects, the ePTFE base material is first applied to the working length and then the TiCh. In some aspects, the ePTFE may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the ePTFE may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, TiCh and/or ePTFE nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon.
[0045] In aspects, the exterior coating layer is a composite of TiCh and ETFE. In some aspects, the TiCh is embedded within the ETFE or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the ETFE. In some aspects, the ETFE base material is first applied to the working length and then the TiCh. In some aspects, the ETFE may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the ETFE may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, TiCh and/or ETFE nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon [0046] In aspects, the exterior coating layer is a composite of TiCh and FEP. In some aspects, the TiCh is embedded within the FEP or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the FEP. In some aspects, the FEP base material is first applied to the working length and then the TiCh. In some aspects, the FEP may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the FEP may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, TiCh and/or FEP nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon
[0047] In aspects, the exterior coating layer is a composite of TiCh and PFA. In some aspects, the TiCh is embedded within the PFA or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the PFA. In some aspects, the PFA base material is first applied to the working length and then the TiCh. In some aspects, the PFA may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the PFA may be pre-treated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, TiCh and/or PFA nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon
[0048] In aspects, the exterior coating layer is a composite of TiCh and E-CTFE. In some aspects, the TiCh is embedded within the E-CTFE or deposited thereon. In some aspects, the TiCh is bound and/or embedded and/or cross-linked with the E-CTFE. In some aspects, the E-CTFE base material is first applied to the working length and then the TiCh. In some aspects, the E-CTFE may be additionally treated, such as with an intermediary like an amino acid and the TiCh allowed to covalently bind thereto. In aspects, the E-CTFE may be pretreated with energy, such as plasma, to provide radicals on the surface of the base material with which the TiCh and/or intermediary, such as amino acid, can bind. In some aspects, TiCh and/or E-CTFE nanoparticles can be embedded within a TiCh sol gel, dip-coated and then dried thereon
[0049] In some aspects, the base material is bound or cross-linked with a composite of the base material and TiCh, such as TiCh-PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh- ETFE, TiO2-E-CTFE, or a combination thereof. As such, the present disclosure may include a base material of PTFE bound to TiCh-PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh- ETFE, TiO2-E-CTFE, or a combination thereof, a base material of ePTFE bound to TiCh- PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh-ETFE, TiO2-E-CTFE , or a combination thereof, a base material of ETFE bound to TiCh-PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh-ETFE, TiO2-E-CTFE, or a combination thereof, a base material of PFA bound to TiCh- PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh-ETFE, TiO2-E-CTFE, or a combination thereof, a base material of E-CTFE bound to TiCh-PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh-ETFE, TiO2-E-CTFE, or a combination thereof, and/or a base material of FEP bound to TiCh-PTFE, TiCh-ePTFE, TiCh-PFA, TiCh-FEP, TiCh-ETFE, TiO2-E-CTFE, or a combination thereof. The composite material may be applied to the base material already deposited on the exterior surface of the working length. The composite material may be applied as a slurry or a solution with the two components dissolved or suspended therein.
[0050] In some aspects, the base material may include one or more surfactant materials to increase adhesion to the exterior of the working length. In some aspects, the surfactant is a non-ionic surfactant. By way of example and not limitation, such may include, perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or combinations thereof. In some aspects, the exterior coating layer(s) may include multiple excipients, and one excipient is more hydrophilic than one or more of the other excipients. In another embodiment, the exterior coating layer multiple excipients, and one excipient has a different structure from that of one or more of the other excipients. In yet another aspect, the coating layer includes multiple excipients. Some aspects of the present disclosure may include a mixture of at least two additional excipients, for example, a combination of one or more surfactants and one or more chemical compound with one or more hydroxyl, amine, carbonyl, carboxyl, amides or ester moieties. By incorporating a mixture of multiple excipients, the coating layer may have improved properties over a formulation with only one excipient or no excipient.
[0051] In aspects, the exterior of the working length may be pre-treated or precoated with one or more intermediary layers to increase the adhesion of the base material to the exterior of the working length. Such may include an adhesive coating and/or plasma pretreatment to generate radical with which the base material can more strongly interact. In some aspects, the intermediary coating may be of the base material as described herein. FIG. 2 shows view wherein a TiCh composite overlays the base material on the substrate of the exterior surface of an endoscopic device. [0052] In aspects, the exterior coating layer is applied to the exterior surface of the working length of a bronchoscope and/or on a coating preapplied thereon. It will be appreciated the exterior coating layer can be applied to any endobronchial device, particular when considering the dry lubricant and antimicrobial properties provided thereby. In aspects, the coating may be used with a re-usable or single use bronchoscope. In aspects, the bronchoscope may be a rigid bronchoscope or a flexible bronchoscope.
[0053] While particular aspects have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subj ect matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.
[0054] It is appreciated that all reagents are obtainable by sources known in the art unless otherwise specified.
[0055] It is also to be understood that this disclosure is not limited to the specific aspects and methods described herein, as specific components and/or conditions may, of course, vary. Furthermore, the terminology used herein is used only for the purpose of describing particular aspects of the present disclosure and is not intended to be limiting in any way. It will be also understood that, although the terms “first,” “second,” “third” etc. may be used herein to describe various elements, components, regions, layers, and/or sections, these elements, components, regions, layers, and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section. Thus, “a first element,” “component,” “region,” “layer,” or “section” discussed below could be termed a second (or other) element, component, region, layer, or section without departing from the teachings herein. Similarly, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms, including “at least one,” unless the content clearly indicates otherwise. “Or” means “and/or.” As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof. The term “or a combination thereof’ means a combination including at least one of the foregoing elements.
[0056] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
[0057] Reference is made in detail to exemplary compositions, aspects and methods of the present disclosure, which constitute the best modes of practicing the disclosure presently known to the inventors. The Figures are not necessarily to scale. However, it is to be understood that the disclosed aspects are merely exemplary of the disclosure that may be embodied in various and alternative forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for any aspect of the disclosure and/or as a representative basis for teaching one skilled in the art to variously employ the present disclosure.
[0058] Patents, publications, and applications mentioned in the specification are indicative of the levels of those skilled in the art to which the disclosure pertains. These patents, publications, and applications are incorporated herein by reference to the same extent as if each individual patent, publication, or application was specifically and individually incorporated herein by reference.
[0059] The foregoing description is illustrative of particular embodiments of the disclosure, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the disclosure.

Claims

1. An exterior coating layer covering at least a part of a working length of a bronchoscope, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh).
2. The exterior coating layer of claim 1, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
3. The exterior coating layer of claim 1 or 2, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
4. The exterior coating layer of claim 1, 2, or 3, wherein TiCh is present as a nanoparticle.
5. The exterior coating layer of claim 4, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
6. An exterior coating layer covering at least a part of a working length of a bronchoscope, wherein the exterior coating layer comprises a base material and titanium-dioxide (TiCh) composite.
7. The exterior coating layer of claim 6, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE.
8. The exterior coating layer of claim 6 or 7, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
9. The exterior coating layer of claim 6, 7, or 8, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
10. The exterior coating layer of claim 6, 7, 8, or 9, wherein TiCh is present as a nanoparticle.
11. The exterior coating layer of claim 10, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
12. The exterior coating layer of claim 1 or 6, wherein the base material further comprises a nonionic surfactant.
13. The exterior coating layer of claim 12, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
14. A method for assessing the airways of a subject comprising provding a bronchoscope through the mouth or nose of a subject, wherein a working length of the bronchoscope comprises the exterior coating layer of any of claims 1-13.
15. An endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer of any of claim 1-13.
16. An endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer, wherein the exterior coating layer comprises a base material and titaniumdioxide (TiCh)
17. The endobronchial device of claim 16, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
18. The endobronchial device of claim 16 or 17, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
19. The endobronchial device of claim 16, 17, or 18, wherein TiCh is present as a nanoparticle.
20. The endobronchial device of claim 19, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
21. The endobronchial device of claim 16, wherein the base material further comprises a nonionic surfactant.
22. The endobronchial device of claim 21, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
23. An endobronchial device comprising a working length configured to enter the airway of a human subject, wherein at least part of an exterior surface of the working length is covered by the exterior coating layer, wherein the exterior coating layer comprises a base material and titaniumdioxide (TiO2) composite.
24. The endobronchial device of claim 23, wherein the TiCh composite comprises TiO2 and at least one of PTFE, ePTFE, ETFE, FEP, PF A, and E-CTFE.
25. The endobronchial device of claim 23 or 24, wherein the base material is chosen from polytetrfluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), chlorotrifluoroethylene (E-CTFE), perfluoroalkoxy (PF A), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP).
26. The endobronchial device of claim 23, 24, or 25, wherein TiCh is present at a concentration of about 0.01 to 10 pg/mm2.
27. The endobronchial device of claim 23, 24, 25, or 26, wherein TiCh is present as a nanoparticle.
28. The endobronchial device of claim 27, wherein the nanoparticle has a mean width of 0.1 nm to 100 nm.
29. The endobronchial device of claim 23, wherein the base material further comprises a nonionic surfactant.
30. The endobronchial device of claim 29, wherein the nonionic surfactant is chosen from perfluoroacetic acid, polysorbate 20 (Tween® 20), polysorbate 60 (Tween® 60), polysorbate 80 (Tween® 80), tricosaethylene glycol dodecyl ether (Brij L23), polyoxyethylene (20) oleyl ether (Brij 020), or a combination thereof.
PCT/US2023/076831 2023-10-13 2023-10-13 Re-usable bronchoscope coated with antimicrobial hydrophilic coating Pending WO2025080272A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090318746A1 (en) * 2006-01-31 2009-12-24 Angiotech Biocoatings Corp. Lubricious echogenic coatings
US11446414B2 (en) * 2017-03-30 2022-09-20 Terumo Kabushiki Kaisha Medical device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090318746A1 (en) * 2006-01-31 2009-12-24 Angiotech Biocoatings Corp. Lubricious echogenic coatings
US11446414B2 (en) * 2017-03-30 2022-09-20 Terumo Kabushiki Kaisha Medical device

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ZHANG ET AL., APP. SURFACE SCI., vol. 490, 2019, pages 231 - 241
ZHANG SHUAI ET AL: "Advanced titanium dioxide-polytetrafluorethylene (TiO2-PTFE) nanocomposite coatings on stainless steel surfaces with antibacterial and anti-corrosion properties", APPLIED SURFACE SCIENCE, vol. 490, 1 October 2019 (2019-10-01), pages 231 - 241, XP085720633, ISSN: 0169-4332, DOI: 10.1016/J.APSUSC.2019.06.070 *

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