WO2020060516A2

WO2020060516A2 - Medical devices coated with boron nanoparticles having antimicrobial properties

Info

Publication number: WO2020060516A2
Application number: PCT/TR2019/050664
Authority: WO
Inventors: Seda KELEŞTEMUR
Original assignee: Istanbul Medipol Universitesi
Priority date: 2018-08-09
Filing date: 2019-08-08
Publication date: 2020-03-26
Also published as: WO2020060516A3

Abstract

The present invention relates to medical devices coated with a coating containing boron nanoparticles, and to the use of boron nanoparticles for the preparation of medical devices with antimicrobial properties.

Description

MEDICAL DEVICES COATED WITH BORON NANOPARTICLES HAVING

ANTIMICROBIAL PROPERTIES

Technical Field

The present invention relates to medical devices coated with a coating comprising boron nanoparticles, and to the use of boron nanoparticles for the preparation of medical devices with antimicrobial properties.

State of the Art

Latex, silicone, polyvinyl chloride and polyurethane-like materials that are used in the production of catheters and similar medical devices provide a suitable environment for the attachment and colonization of microorganisms and for formation of biofilms. Microorganisms especially after the formation of biofilms on catheters and similar medical devices can cause sepsis in patient and even death of the patient. Therefore, coating the surface of catheters and similar medical devices with a material having antimicrobial effect prevents biofilm formation on the surface of medical devices with short-term and long-term use and contributes to the solution of this problem.

In the prior art, clinically tested antimicrobial coating methods are available. Of the methods in the prior art, silver coating and antibiotic coating are the most prominent methods.

Silver coatings are problematic in use, because of their high cost and occasional toxic effects, and antibiotic coatings are problematic because they cause antibiotic resistance.

Although, clinically not yet tested, chlorohexidine, triclosan, antimicrobial peptides, bacteriophages, antimicrobial enzymes, nitric oxide, polyzwitter ions, polymeric coatings and liposomes are used to coat the surface of medical devices, such as catheters. The full range of studies on these materials are scarce. For example, the release mechanism of chlorohexidine is not fully understood. Disadvantages such as limited use due to the toxic effects of the materials used in the coating, or denaturing of biological materials such as enzymes during the sterilization process restrict the use of these materials in the manufacture of medical devices.

Considering the state of the art, it is seen that there is need for new coatings that will impart catheters and similar medical devices antimicrobial property and prevent formation of bio film on them and for medical devices prepared with these coatings.

There is also a need for coatings that are non-toxic and do not cause antimicrobial resistance to the patient.

In order to meet the aforementioned needs and to develop coatings that provide antimicrobial properties to catheters and similar medical devices, the inventors have found that boron nanoparticle coatings have antimicrobial properties and prevent biofilm formation.

Detailed Description of the Invention

The invention relates to the use of coatings comprising boron nanoparticles on medical device surfaces.

Boron is naturally present in the world and boron ores are among the top resources of our country. For this reason, the widespread use of boron products in different fields paves the way for the efficient use and utilization of available resources. At the same time, it is possible to switch to an economically advantageous position over many of the coating materials currently used.

Boron nanoparticles will prolong the use of these medical devices not only because of their antimicrobial effect, but also because they provide resistance to the surface of catheters and similar medical devices and increase their resistance to external effects. The prolonged use of said medical devices will provide an economic advantage in the medical field.

Boron nanoparticles are used for the first time in the field of medical product development. In this way, a new field of application other than neutron capture therapy, which is one of the superior properties of boron nanoparticles in the clinic, can be utilized. In the context of the invention, the term "medical device" refers to any device, tool appliance, application, machine, equipment, implant, additive for in vitro use, material or other similar or related articles intended by the manufacturer for use in humans for (a) the diagnosis, prevention, monitoring, treatment or reduction of the disease in a mammal, for example a human, (b) the diagnosis, monitoring, treatment, reduction or compensation of an injury; any device, instrument used alone or in combination for investigating, replacing, altering or supporting the anatomy of the physiological process, (d) supporting or sustaining life, (e) protecting from pregnancy, (e) examining human body specimens in vitro either alone or in combination with one another.

In one embodiment of the invention, a coating comprising boron nanoparticle is used in all medical devices meeting the above definition. The coating may be present in the medical device (i.e. its inner surface), on the outside (i.e. its outer surface), or both inside and outside (i.e. both its inner surface and its outer surface).

In another aspect, the invention relates to medical devices coated with a coating comprising boron nanoparticles.

In one embodiment of the invention, the medical device can be re-useable surgical instruments such as keratoscope, ophthalmoscope, otoscope, scalpel, surgical microscope, hand-held surgical saw, surgical scissors or acupuncture needles, angioscope, biopsy needle kits, blood transfusion tubes, choledochoscope, gastroscope, infusion cannula, intubation set, syringe needle, medical needle, sigmaidoscope, aspiration catheters, trachea tubes, urinary catheter, e.g. foley catheter, electrocautery device, electrosurgical unit, hip implant, implantable stapler, infusion port, intraocular lenses, maxillo facial implants, prosthetic joints, ureteral stents, aneurysm clips, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiac use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), cardiovascular stent, cerebrospinal resistances, coronary drug eluting stents, embolization implants, iliac stents, implantable infusion pumps, implantable hearing aids, implantable, implantable pacemaker, implantable stimulator, contraceptive devices for uterus, neurologic catheters, neuroendoscopes, cardiac valve prosthetic vessels can be selected from a group of urological catheters. In a preferred embodiment of the invention, the medical device is selected from aspiration catheters, urinary catheters such as foley catheters, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiac use, cardiovascular catheters (e.g, angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters) neurological catheters, urological catheters.

In a particularly preferred embodiment of the invention, the medical device is a foley catheter.

Accordingly, one embodiment of the invention is directed to, aspiration catheters, urinary catheters such as foley catheters, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiovascular use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheter, etc.), neurological catheters, urological catheters that are coated with boron nanoparticles.

In another aspect, the present invention relates to use of coatings comprising boron nanoparticles for coating the surface of aspiration catheters, urinary catheters such as foley catheters, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiac use, cardiovascular catheters (e.g., angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), neurological catheters, urological catheters.

In an embodiment of the invention, the coating comprising the boron nanoparticle according to the invention may be on the inner surface or the outer surface of the medical device, or on both the inner and outer surface.

In a preferred embodiment of the invention, the expression "coating comprising boron nanoparticles" refers to coatings containing only boron nanoparticles.

In a preferred embodiment of the invention, the expression "coating comprising boron nanoparticles" refers to coatings comprising at least one excipient in addition to boron nanoparticles.

Said excipient may be any substance which may aid in improving the physical properties such as fluidity, surface adhesion, etc. in the use of boron nanoparticles as coatings. The boron nanoparticles used in the context of the invention have a size in the range of 1- 1000 nm, preferably in the range of 1-500 nm.

The boron nanoparticles used in the context of the invention may be made of elemental boron or salts of boron that are known in the art. Within the scope of the invention, preferably, boron nanoparticles obtained from the elemental board are used. FIG. 1, which does not limit the scope of the invention, is enclosed in this description. The description of Figure 1 and the description of the numbers contained herein are given below.

Figure 1 : Boron nanoparticle coated Foley catheter

1 : Urine entry

2: The balloon that swells and prevents the catheter inserted into the patient from coming out

3: Main section of catheter

4: The part where the urine is poured into the bladder in the outside

5: The section used to inflate the balloon after the catheter is inserted into the patient

The inner and outer surfaces of the catheter of Figure 1 are coated with a coating containing boron nanoparticle.

Around these basic concepts, it is possible to develop a wide variety of applications relating to the subject matter of the invention, the invention not being limited to the examples described herein, but essentially as set forth in the claims.

It is evident that a person skilled in the art can demonstrate the novelty disclosed in the invention using similar embodiments and / or may apply this embodiment to other fields of similar purpose as are used in the art. It is therefore evident that such embodiments will lack the criterion of novelty and in particular the inventive step.

Claims

1. Use of boron nanoparticle-containing coatings on medical device surfaces.

2. Use according to claim 1, wherein the medical device is selected from a group comprising; reusable surgical instruments such as keratoscope, ophthalmoscope, otoscope, scalpel, surgical microscope, hand-held surgical saw, surgical scissors, acupuncture needles, angioscope, biopsy needle kits, blood transfusion tubes, choledochoscope, gastroscope, infusion cannula, intubation set, syringe needle, medical suture needle, sigmaidoscope, aspiration catheters, trachea tubes, urinary catheters, e.g. foley catheter, electrocautery device, electro surgical unit, hip implant, implantable stapler, infusion port, intraocular lenses , maxillo facial implants, prosthetic joints, ureteral stents, aneurysm clips, angioplasty balloon catheters, arterioscopes, cannula for cardiac or neurological use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), canrdiovascular stents, carotid artery shunt, cerebrospinal resistances, coronary drug eluting stents, embolization implants, iliac stent, implantable infusion pumps, implantable hearing aids, implantable pacemaker, implantable stimulator, uterine contraceptive devices, neurologic catheters, neuroendoscopes, cardiac valve prostheses, prosthetic vessels, urological catheters.

3. Use according to claims 1-2, wherein the medical device is selected from a group comprising aspiration catheters, urinary catheters, such as foley catheters, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiac use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), neurological catheters, urological catheters.

4. Use according to claim 3, wherein the medical device is a foley catheter.

5. Use according to claims 1-4, on the inner surface or the outer surface of the medical device or both the inner and outer surface.

6. Use according to claims 1-5, wherein the coating comprising boron nanoparticle comprises only boron nanoparticles or comprises at least one excipient as well as boron nanoparticles.

7. Use according to claims 1-6, wherein the boron nanoparticles in the coating comprising boron nanoparticles have a size in the range of 1-1000 nm.

8. Medical devices coated with a coating comprising boron nanoparticles.

9. Medical device according to claim 8 selected from a group comprising; reusable surgical instruments such as keratoscope, ophthalmoscope, otoscope, scalpel, surgical microscope, hand-held surgical saw, surgical scissors, acupuncture needles, angioscope, biopsy needle kits, blood transfusion tubes, choledochoscope, gastroscope, infusion cannula, intubation set, syringe needle, medical suture needle, sigmaidoscope, aspiration catheters, trachea tubes, urinary catheters, e.g. foley catheter, electrocautery device, electrosurgical unit, hip implant, implantable stapler, infusion port, intraocular lenses , maxillo facial implants, prosthetic joints, ureteral stents, aneurysm clips, angioplasty balloon catheters, art erio scopes, cannula for cardiac or neurological use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), canrdiovascular stents, carotid artery shunt, cerebrospinal resistances, coronary drug eluting stents, embolization implants, iliac stent, implantable infusion pumps, implantable hearing aids, implantable pacemaker, implantable stimulator, uterine contraceptive devices, neurologic catheters, neuroendoscopes, cardiac valve prostheses, prosthetic vessels, urological catheters.

10. Medical device according to claim 9, wherein the medical device is selected from a group comprising aspiration catheters, urinary catheters, such as foley catheters, angioplasty balloon catheters, arterioscopes, cannula for neurological or cardiac use, cardiovascular catheters (e.g. angiography, atherectomy, angioplasty, pericardium excretion, septostomy or vulvoplasty catheters), neurological catheters, urological catheters.

11. A medical device according to claim 10, wherein the medical device is a foley catheter.

12. A medical device according to claims 8-11, wherein the coating comprising boron nanoparticle is located on the inner surface or outer surface of the medical device, or on both the inner and outer surface.

13. A medical device according to claims 8-12, wherein the coating comprising boron nanoparticle comprises only boron nanoparticles.

14. A medical device according to claims 8-12, wherein the coating comprising boron nanoparticle comprises at least one excipient in addition to boron nanoparticles.

15. A medical device according to claims 8-14, wherein the boron nanoparticles are made from known salts of boron or from elemental boron.