US20190015560A1 - Composition for catheter and production method therefor - Google Patents
Composition for catheter and production method therefor Download PDFInfo
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- US20190015560A1 US20190015560A1 US16/068,173 US201716068173A US2019015560A1 US 20190015560 A1 US20190015560 A1 US 20190015560A1 US 201716068173 A US201716068173 A US 201716068173A US 2019015560 A1 US2019015560 A1 US 2019015560A1
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- Prior art keywords
- catheter
- foley
- carbon nanotube
- zno
- silicon
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Images
Classifications
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Definitions
- the present invention relates to a composition for producing a foley catheter which is inserted in vivo and a method for producing the same.
- bladder paralysis is inevitably accompanied in such patients.
- a treatment of bladder paralysis is entirely dependent on the prognosis of the patient, and a foley catheter is maintained in the bladder as a treatment for these patients.
- the foley catheter is made by attaching a foley to the distal end portion of the tubular catheter body so that the foley is expanded by the fluid introduced from the outside to have a balloon shape, which the catheter is held in the bladder.
- an antibiotic drug or a substance is applied to a foley catheter made of a silicone to suppress invasion of bacteria.
- antibiotics are initially effective in antibiotics, biofilm formation is occurred inevitably due to the intubation of the urinary tract for more than from 2 to 3 days according to the nature of the catheter.
- Such biofilm formation may cause the antibiotic effect of the foley catheter to decrease or disappear so that there is a problem that the complications such as urinary tract infection is resulted and treatment for this should be accompanied and the length of hospital stay is prolonged.
- inventive step of the present invention should not be judged based on the recognition for the problems and challenge of the prior art described above because such recognition is not obvious to those of ordinary skill in the art.
- the composition for producing the foley catheter which is inserted in vivo consists of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon, wherein from 1.0 to 2.2 parts by weight of the said carbon nanotube polymer are combined with 100 parts by weight of silicon.
- CNT Polymer carbon nanotube polymer
- ZnO zinc oxide
- the said composition for the catheter foley is used to produce the foley for catheter being affixed to the catheter body to be inflatable by fluid externally introduced, and made of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon, and from 4.0 to 13.2 parts by weight of the said carbon nanotube polymer are combined with 100 parts by weight of silicon.
- CNT Polymer carbon nanotube polymer
- ZnO zinc oxide
- the process for producing a foley catheter of the present invention comprises the step of composite combining the dispersed carbon nanotube and zinc oxide (ZnO) with silicon and then constituting the material which a carbon nanotube polymer (CNT Polymer) is combined to silicon.
- a catheter body and a foley for catheter are made of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon so that it is possible to inhibit the formation of a biofilm, which is the source of bacterial infection, without coating a separate antibiotic materials.
- CNT Polymer carbon nanotube polymer
- ZnO zinc oxide
- the foley for catheter according to the present invention has no side effects such as resistance of antibiotics, and is characterized in that the lifetime of the carbon nanotube polymer is decided according to the amount of static electricity possessed by the said carbon nanotube polymer and the carbon nanotube polymer has high thermal conductivity so that it has the effect of minimizing the patient's rejecting feel during inserting process into a body and reducing the additional replacement cost and the increase of the medical expenses due to the infection.
- FIG. 1 is a perspective view showing a configuration of a foley catheter according to an embodiment of the present invention.
- FIG. 2 is a cross sectional view showing an example of a cross sectional configuration of the foley catheter shown in FIG. 1 .
- FIGS. 3 to 8 are diagrams showing experimental results on an effect for inhibiting a biofilm formation of the material constituting the foley catheter and the foley for catheter.
- FIG. 9 is a view showing experimental results for explaining an effect of reducing the foreign sensation when the materials constituting a foley catheter and a foley for catheter are inserted into the human body.
- FIG. 10 is a drawing for explaining the configuration and operation of a foley for catheter according to an embodiment of the present invention.
- FIG. 11 is a drawing showing one embodiment of the configuration of a foley for catheter according to the present invention in more detail.
- FIGS. 12 to 16 are cross-sectional views showing examples of the cross sectional configuration of a foley for catheter shown in FIG. 11 .
- FIG. 1 is a perspective view showing a configuration of a foley catheter according to an embodiment of the present invention
- FIG. 2 is a cross sectional view of a foley catheter taken along line B-B of FIG. 1 as an example of cross sectional constitution of a foley catheter.
- a catheter according to an embodiment of the present invention may be a urine catheter for discharging urine in a bladder of a patient.
- a foley catheter may be constituted such that one side of catheter body is provided with a urine inlet and an inflatable foley, and a main tube positioned at the center of the catheter body communicates with a urine discharging part located on the other side of the catheter body to discharge urine in the bladder of the patient.
- the catheter and the foley for catheter according to an embodiment of the present invention may be applied to various catheters such as a cardiovascular catheter in addition to the urethral catheter as described above.
- the foley catheter comprises a catheter body 100 which is a tubular tube, and a foley for catheter 200 that is joined to the catheter body 100 to be inflatable by an externally introduced fluid.
- catheter body 100 may be formed with a urine passage 110 in which one end 50 is closed and urine moves and fluid passages 120 and 121 in which fluids move, respectively.
- the urine inlet 11 is connected to the urine passage 110 of the catheter body 100 and the fluid outlet 21 may be connected to the fluid passages 120 and 121 of the catheter body 100 .
- FIG. 2 illustrates a catheter and a foley for catheter according to an embodiment of the present invention, for example, in which a catheter body 100 has one urine passage 110 and two fluid passages 120 and 121 , the present invention is not limited thereto.
- one fluid passageway may be formed in the catheter body 100 and in case of a catheter of three-way mode rather than a two-way mode as shown in FIG. 1 , a drug passage (not shown) may be additionally provided for introducing the medicine separately from the urine passage 110 .
- the fluid passages 120 and 121 are connected to the fluid outlet 21 respectively so that fluid introduced from the outside through the fluid inlet 23 flows through the fluid passages 120 and 121 and the fluid outlet 21 and can be delivered to the jointed portion of the foley for catheter 200 .
- said fluid may be a gas such as air or a liquid such as saline.
- the foley 200 for catheter is composed of a material which may be expanded or contracted as the fluid flows in, and can be bonded to the catheter body 100 while surrounding the fluid outlet 21 formed in the catheter body 100 .
- the foley catheter and the foley for catheter according to an embodiment of the present invention having the structures described with reference to FIGS. 1 and 2 are made of a material which a carbon nanotube polymer (CNT polymer) is combined with a silicone, and it is possible to inhibit the formation of a biofilm which is the source of bacterial infection, without application or coating of antibiotics.
- CNT polymer carbon nanotube polymer
- the carbon nanotubes are cylindrical crystals made of a carbon atom and have a diameter from 2 to 20 nm (1 nm being corresponding to 1/1,000,000 m) and a length from several hundred to several thousand nm.
- One carbon atom in the carbon nanotube forms a hexagonal honeycomb pattern by sp2 bonding with three other carbon atoms around it, which is called nanotube because the diameter of the tube is very small of about nanometers (nm).
- the carbon nanotube polymer is a polymer in which carbon nanotubes (CNT) are bonded with zinc oxide (ZnO), and wherein carbon nanotubes (CNT) and zinc oxide (ZnO) can be polymerized at the same ratio from each other or zinc oxide (ZnO) can have a higher ratio than carbon nanotubes (CNT), and vice versa if necessary.
- the catheter body 100 constituting the catheter according to an embodiment of the present invention may be consisted of materials which are blended 100 parts by weight of silicon with 1.0 to 2.2 parts by weight of carbon nanotube polymer, but the combining ratio may be variable.
- the carbon nanotube polymer as a component of the catheter body 100 has a constant capacitance in response to a potential in the intubated human body, so that such a capacitance is harmless to the human body, but has a galvanic effect which are deadly to bacteria and biofilms, which enable to minimizes the formation of biofilm, and the rejection of the subject during inserting process into the human body due to the high thermal conductivity which is characteristic of carbon nanotubes.
- the foley catheter according to the present invention can be used for at least 4 to 5 weeks due to the silicon which the carbon nanotube polymer (CNT polymer) having the above described effect is added.
- the carbon nanotube (CNT) may be a multi-walled carbon nanotube (MWNT) since the multi-walled carbon nanotube (MWNT) has a merit to use in a solid state and is likely to be commercialized in terms of price.
- MWNT multi-walled carbon nanotube
- the foley catheter and the foley for catheter according to an embodiment of the present invention may be consisted of material which a carbon nanotube polymer (CNT polymer) bonded carbon nanotubes (CNT) and zinc oxide (ZnO) as below chemical formula 1 is combined with a silicone respectively.
- CNT polymer carbon nanotube polymer
- ZnO zinc oxide
- m, n and p represent the number of each of molecules of silicon, zinc oxide (ZnO) and carbon nanotube (CNT), m is 50 to 300, n is 7 to 30, and p is 10 to 50, but the present invention is not limited thereto.
- the above m, n, and p may be set different from each other.
- the catheter body 100 and the foley for catheter 200 for constituting the catheter according to an embodiment of the present invention may be a tubular tube obtained by extruding a carbon nanotube polymer (CNT) bonded carbon nanotube (CNT) and zinc oxide (ZnO) together with silicone in a predetermined ratio.
- CNT carbon nanotube polymer
- ZnO zinc oxide
- the above materials may be formed by compounding carbon nanotubes (CNT) and zinc oxide (ZnO) dispersed using a chemical vapor deposition (CVD) composite into silicon, for example, at a pressure of 1,000,000 Pa and a pressure of 50° C. for 30 minutes via dispersing process.
- CNT carbon nanotubes
- ZnO zinc oxide
- CVD chemical vapor deposition
- a carbon nanotube polymer composed of carbon nanotubes (CNT) and zinc oxide (ZnO) can be uniformly inserted into the silicon, whereby the catheter and the foley for catheter made of this material can have antibacterial activity uniformly with regardless of location.
- FIGS. 3 to 5 show the results obtained by culturing E. coli ( Escherichia coli .) which is a major pathogen of urinary tract infection, on a catheter slice composed of the above materials for 3 days, 5 days, and 7 days, and experiment of forming degree of biofilm using the crystal violet method.
- E. coli Escherichia coli .
- FIG. 6 is a graph showing the results of the experiment described above with respect to the experimental materials
- FIG. 7 is a graph showing the results of the experiments described above with respect to the culturing time.
- the average value of absorbance is generally lower than that in the case of a material in which the carbon nanotubes (CNT) are mixed with silicon (i.e. 0% of zinc oxide (ZnO)) and 1% of zinc oxide (ZnO) is mixed with silicon and carbon nanotube (CNT), thereby the inhibitory effect on the biofilm formation of a major strain of urinary tract infection, E. coli ( Escherichia coli .) is clearly shown.
- FIG. 8 is a photograph of the results obtained by culturing E. coli ( Escherichia coli ) in a material having a zinc oxide (ZnO) blending ratio of 1% for 7 days and then taking the results of the experiment with a scanning electron microscope (SEM).
- E. coli Escherichia coli
- ZnO zinc oxide
- the material constituting the catheter and the foley for catheter according to an embodiment of the present invention have a bactericidal reduction rate of more than 99.9% and a bacteriostatic reduction rate for staphylococcus aureus , pneumococcus, Escherichia coli and pseudomonas aeruginosa in addition to said E. coli .
- the catheter and the foley for catheter configured as described above can minimize the patient's rejection feeling in the process of inserting the human body due to the high heat conduction characteristic of the carbon nanotube.
- FIG. 9 is view showing experimental results for explaining an effect of reducing the foreign sensation when the materials constituting a foley catheter and a foley for catheter are inserted into the human body.
- FIG. 9 ( a ) is a thermal image of a catheter made of silicon in which carbon nanotubes do not internalized
- FIG. 9 ( b ) is a thermal image of a catheter made of silicon in which carbon nanotubes are internalized.
- FIG. 10 is a drawing for explaining the configuration and operation of a foley for catheter according to an embodiment of the present invention. The descriptions for the same components as those described with reference to FIGS. 1 to 9 will be omitted herein.
- a catheter body 100 is formed with a urine inlet 11 and a foley for catheter 200 adjacent one end 50 of the foley for catheter that is inserted into the bladder.
- the foley for catheter 200 may expand to form a balloon when fluid (e.g., air or saline) is introduced from the fluid inlet 23 provided on the other side of the catheter.
- fluid e.g., air or saline
- a fluid may be introduced in a manner such that a fluid is previously injected into a syringe, the syringe needle is inserted into the inflow hole 22 at the end of the fluid inflow portion 23 , and the syringe is compressed.
- a foley for catheter 200 configured to abut one end 50 of the catheter body 100 is inserted into the bladder, and at that state, the fluids flow from the fluid inlet 23 through the fluid passages 120 and 121 and the fluid outlet 21 into the foley for catheter 200 , thereby the foley for catheter 200 bulges in a balloon shape and spans the bladder neck 60 to secure the catheter within the bladder.
- a urine passage 110 connected to the urine inlet 11 is formed at the center of a cross section of the catheter body 100 and a urine outlet 13 is formed at the end of the urine passage 110 .
- the urine generated in the urethra is introduced into the urine passage 110 through the urine inlet 11 located in the urethra, and then discharged via the urine outlet 12 , which is the end of the urine discharging portion 13 located at outside of the urethra.
- FIG. 11 shows a drawing showing one embodiment of the configuration of a foley for catheter according to the present invention in more detail, and specifically an enlarged representation of the portion of the foley for catheter 200 shown in FIGS. 1 and 11 where it is joined.
- bonding surfaces 210 and 211 are formed at both ends of the foley for catheter 200 to be joined to the catheter body 100 and bonding surfaces 210 and 211 may be bonded to the catheter body 100 using an adhesive during process forming the foley for catheter 200 at the catheter body 100 .
- a carbon nanotube polymer (CNT polymer) in which carbon nanotubes and zinc oxide (ZnO) are bonded is combined with a silicone and then is extruded into a tubular tube to form a catheter body 100 .
- CNT polymer in which carbon nanotubes and zinc oxide (ZnO) are bonded is combined with a silicone and then is extruded or molded into a tubular tube to form a foley for catheter 200 .
- the mixing ratio of the carbon nanotube, zinc oxide (ZnO), or carbon nanotube polymer as a raw material for producing the catheter body 100 and the mixing ratio of the carbon nanotube, zinc oxide (ZnO) or a carbon nanotube polymer as a raw material for producing the foley for catheter 200 may be different.
- the surface area is increased, and the distribution of the carbon nanotube polymer per unit area is decreased, and the antibacterial ability may be lowered.
- the combining ratio of the carbon nanotube polymer in the foley for catheter 200 is preferably higher than that of the carbon nanotube polymer in the catheter body 100 . Therefore, the distribution of the carbon nanotube polymer per unit area has the same or similar range as that of the catheter body 100 even when inflated, so that a uniform infectious power can be maintained regardless of the position of the foley for catheter 200 .
- the foley for catheter 200 expands to increase the surface area by about 4 to 6 times, as being described above, when the catheter body 100 is formed of a material mixed with 1.0 to 2.2 parts by weight of carbon nanotube polymer relative to 100 parts by weight of silicon, the foley for catheter 200 may be composed of a material blended with 4.0 to 13.2 parts by weight of carbon nanotube polymer relative to 100 parts by weight of silicone in proportion to an increase in surface area.
- n and m in the chemical formula 1 increase in proportion to the increase in surface area upon expansion of the foley for catheter 200 .
- bonding surfaces 210 and 211 of the foley for catheter 200 are attached to the catheter body 100 and the foley catheter can be manufactured by forming a tip provided with an urine inlet 11 at one end of the catheter body 100 .
- the method of manufacturing a foley catheter and the method of forming a foley for a catheter according to an embodiment of the present invention may further include additional steps such as a drying step in addition to the steps described above and a separate step may be added.
- FIGS. 12 to 16 are cross-sectional views showing examples of the cross sectional configuration of a foley for catheter shown in FIG. 11 .
- FIG. 12 is a cross-sectional view taken along the C-C line shown in FIG. 11 , showing a structure in which the foley for catheter 200 covers the catheter body 100 having the urine passage 110 and the fluid passages 120 and 121 .
- the current can flow until the potential difference is no longer present between the catheter body 100 shown in FIG. 12 and the foley for catheter 200 .
- zinc oxide creates a high electrical potential and current flow from the foley for catheter 200 to the catheter body 100 at the abutting portion each other.
- ZnO zinc oxide
- An insulating layer 900 is interposed between the catheter body 100 and the foley for catheter 200 as shown in FIG. 13 to prevent current from flowing from the foley for catheter 200 to the catheter body 100 .
- the insulating layer 900 may be composed of a gas such as an air layer or a sterilizing gas layer (for example, EO gas), or a carbon nanotube coating layer having a high concentration.
- a gas such as an air layer or a sterilizing gas layer (for example, EO gas), or a carbon nanotube coating layer having a high concentration.
- the insulating layer 900 By preventing the electric current from flowing from the foley for catheter 200 to the catheter body 100 by the insulating layer 900 , a potential difference due to the difference in the mixing ratio of the carbon nanotube polymer can be maintained, thereby the antibacterial power can be maintained in the same or similar range as the catheter body 100 even when the foley for catheter 200 is inflated.
- the air layer is injected into between catheter body 100 and the foley for catheter 200 or an EO gas treatment or a high concentration carbon nanotube coating may be further applied to the outer surface of the catheter body 100 during the formation of the foley for catheter 200 so that an insulating layer 900 is formed between the catheter body 100 and the foley for catheter 200 .
- FIG. 14 is a cross-sectional view taken along the line D-D shown in FIG. 11 , showing a cross-sectional structure of a portion of bonding surface 210 where the foley for catheter 200 is bonded to the catheter body 100 .
- an insulating film 1000 may be formed on a bonding surface 210 where the foley for catheter 200 is bonded to the catheter body 100 .
- the insulating film 1000 may be formed by coating a high concentration carbon nanotube on the bonding surface 210 as a carbon nanotube insulating film, and when the foley for catheter 200 is inflated, it may be dismantled naturally by increase of a surface area.
- the insulating film 1000 as shown in FIG. 14 is also preferably applied to a cardiovascular catheter.
- FIG. 15 is a cross-sectional view taken along the line E-E shown in FIG. 11 , showing a cross-sectional structure of a portion where the fluid outlet 21 is formed.
- fluid outlets 21 a and 21 b may be formed at the corresponding positions communicated to the two fluid passages 120 and 121 formed in the catheter body 100 , respectively.
- the fluid introduced from the outside flows through the fluid passages 120 and 121 of the catheter body 100 and then flows out through the fluid outlets 21 a and 21 b to the foley for catheter 200 , and then the foley for catheter 200 is expanded by the pressure of the fluid.
- FIG. 16 is a cross-sectional view illustrating the expanded state of the foley for catheter 200 .
- the electrostatic capacity of the foley for catheter 200 may be kept the same or similar to that of the catheter body 100 when expanding so that the antibacterial power of the foley catheter can be uniform.
- the steps according to the manufacturing method may be added or reduced depending on the type or function of the catheter or the foley for catheter according to the present invention.
Abstract
Description
- The present invention relates to a composition for producing a foley catheter which is inserted in vivo and a method for producing the same.
- In general, patients with systemic or lower body paralysis caused by cerebral diseases such as stroke or spinal injuries are increasing year by year due to an increase in the elderly population and an increase rapidly in traffic accidents or industrial accidents.
- A bladder paralysis is inevitably accompanied in such patients. A treatment of bladder paralysis is entirely dependent on the prognosis of the patient, and a foley catheter is maintained in the bladder as a treatment for these patients.
- The foley catheter is made by attaching a foley to the distal end portion of the tubular catheter body so that the foley is expanded by the fluid introduced from the outside to have a balloon shape, which the catheter is held in the bladder.
- In the case of a conventional antibiotic catheter, an antibiotic drug or a substance is applied to a foley catheter made of a silicone to suppress invasion of bacteria. Although antibiotics are initially effective in antibiotics, biofilm formation is occurred inevitably due to the intubation of the urinary tract for more than from 2 to 3 days according to the nature of the catheter.
- Such biofilm formation may cause the antibiotic effect of the foley catheter to decrease or disappear so that there is a problem that the complications such as urinary tract infection is resulted and treatment for this should be accompanied and the length of hospital stay is prolonged.
- In addition, since the antibiotic drugs or substances applied to the surface of the conventional foley catheter are always held in the fastening state, the urinary tract infections and stones are formed, resulting in kidney failure in 40% of the total patients, which is the greatest cause of death.
- On the other hand, in order to solve the problems of the above-mentioned antibiotic catheter, there are some products coated with antibacterial materials such as gold, silver or silver nano. However, there has been a problem that the antibacterial activity is decreased due to peeling of the coated antibacterial substance when used over a certain period of time.
- It should be understood that the inventive step of the present invention should not be judged based on the recognition for the problems and challenge of the prior art described above because such recognition is not obvious to those of ordinary skill in the art.
- Accordingly, it is an object of the present invention to provide a composition for producing a foley catheter having an improved antibacterial property and being able to maintain its antibacterial property even for long-term use, and a method for producing the same.
- According to an embodiment of the present invention, it is characterized in that the composition for producing the foley catheter which is inserted in vivo consists of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon, wherein from 1.0 to 2.2 parts by weight of the said carbon nanotube polymer are combined with 100 parts by weight of silicon.
- In a preferred embodiment of the present invention, it is characterized in that the said composition for the catheter foley is used to produce the foley for catheter being affixed to the catheter body to be inflatable by fluid externally introduced, and made of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon, and from 4.0 to 13.2 parts by weight of the said carbon nanotube polymer are combined with 100 parts by weight of silicon.
- According to an embodiment of the present invention, it is characterized in that the process for producing a foley catheter of the present invention comprises the step of composite combining the dispersed carbon nanotube and zinc oxide (ZnO) with silicon and then constituting the material which a carbon nanotube polymer (CNT Polymer) is combined to silicon.
- Being constituting as the above, according to an embodiment of the present invention, a catheter body and a foley for catheter are made of a material which a carbon nanotube polymer (CNT Polymer) bonded a carbon nanotube and zinc oxide (ZnO) is combined with a silicon so that it is possible to inhibit the formation of a biofilm, which is the source of bacterial infection, without coating a separate antibiotic materials.
- In addition, it has the effect of maintaining antibacterial property by inactivating the bacteria which is stenosed to the foley with keeping an induction of bio potential effect of the carbon nanotube polymer homogeneously.
- In addition, the foley for catheter according to the present invention has no side effects such as resistance of antibiotics, and is characterized in that the lifetime of the carbon nanotube polymer is decided according to the amount of static electricity possessed by the said carbon nanotube polymer and the carbon nanotube polymer has high thermal conductivity so that it has the effect of minimizing the patient's rejecting feel during inserting process into a body and reducing the additional replacement cost and the increase of the medical expenses due to the infection.
- The effects of the present invention described above are merely one of various effects according to the present invention, and the present invention can be realized in various forms according to the application mode of the embodiment.
- The combustion promoter according to the present invention will now be described by way of example only, with reference to the accompanying drawings, in which:
-
FIG. 1 is a perspective view showing a configuration of a foley catheter according to an embodiment of the present invention. -
FIG. 2 is a cross sectional view showing an example of a cross sectional configuration of the foley catheter shown inFIG. 1 . -
FIGS. 3 to 8 are diagrams showing experimental results on an effect for inhibiting a biofilm formation of the material constituting the foley catheter and the foley for catheter. -
FIG. 9 is a view showing experimental results for explaining an effect of reducing the foreign sensation when the materials constituting a foley catheter and a foley for catheter are inserted into the human body. -
FIG. 10 is a drawing for explaining the configuration and operation of a foley for catheter according to an embodiment of the present invention. -
FIG. 11 is a drawing showing one embodiment of the configuration of a foley for catheter according to the present invention in more detail. -
FIGS. 12 to 16 are cross-sectional views showing examples of the cross sectional configuration of a foley for catheter shown inFIG. 11 . - Hereinafter, a foley catheter, a foley for catheter and a method for producing the same according to the present invention will be described in further detail with reference to preferred embodiments. It is to be understood, however, that the scope of the present invention is not limited to these embodiments.
- The foregoing objects, features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying figures. Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying figures. Like reference numerals designate like elements throughout the specification. Furthermore, in the following description, the well-known functions or constructions are not described in detail to avoid obscuring the subject matter of the present invention.
-
FIG. 1 is a perspective view showing a configuration of a foley catheter according to an embodiment of the present invention, andFIG. 2 is a cross sectional view of a foley catheter taken along line B-B ofFIG. 1 as an example of cross sectional constitution of a foley catheter. - A catheter according to an embodiment of the present invention may be a urine catheter for discharging urine in a bladder of a patient. A foley catheter may be constituted such that one side of catheter body is provided with a urine inlet and an inflatable foley, and a main tube positioned at the center of the catheter body communicates with a urine discharging part located on the other side of the catheter body to discharge urine in the bladder of the patient.
- However, the catheter and the foley for catheter according to an embodiment of the present invention may be applied to various catheters such as a cardiovascular catheter in addition to the urethral catheter as described above.
- Referring to
FIGS. 1 and 2 , the foley catheter comprises acatheter body 100 which is a tubular tube, and a foley forcatheter 200 that is joined to thecatheter body 100 to be inflatable by an externally introduced fluid. - More specifically, the inside of
catheter body 100 may be formed with aurine passage 110 in which oneend 50 is closed and urine moves andfluid passages - Furthermore, the
urine inlet 11 is connected to theurine passage 110 of thecatheter body 100 and thefluid outlet 21 may be connected to thefluid passages catheter body 100. - Although
FIG. 2 illustrates a catheter and a foley for catheter according to an embodiment of the present invention, for example, in which acatheter body 100 has oneurine passage 110 and twofluid passages - For example, one fluid passageway may be formed in the
catheter body 100 and in case of a catheter of three-way mode rather than a two-way mode as shown inFIG. 1 , a drug passage (not shown) may be additionally provided for introducing the medicine separately from theurine passage 110. - As being described above, the
fluid passages fluid outlet 21 respectively so that fluid introduced from the outside through thefluid inlet 23 flows through thefluid passages fluid outlet 21 and can be delivered to the jointed portion of the foley forcatheter 200. - Here, said fluid may be a gas such as air or a liquid such as saline.
- The
foley 200 for catheter is composed of a material which may be expanded or contracted as the fluid flows in, and can be bonded to thecatheter body 100 while surrounding thefluid outlet 21 formed in thecatheter body 100. - The foley catheter and the foley for catheter according to an embodiment of the present invention having the structures described with reference to
FIGS. 1 and 2 are made of a material which a carbon nanotube polymer (CNT polymer) is combined with a silicone, and it is possible to inhibit the formation of a biofilm which is the source of bacterial infection, without application or coating of antibiotics. - The carbon nanotubes (CNTs) are cylindrical crystals made of a carbon atom and have a diameter from 2 to 20 nm (1 nm being corresponding to 1/1,000,000 m) and a length from several hundred to several thousand nm. One carbon atom in the carbon nanotube forms a hexagonal honeycomb pattern by sp2 bonding with three other carbon atoms around it, which is called nanotube because the diameter of the tube is very small of about nanometers (nm).
- Furthermore, the carbon nanotube polymer (CNT polymer) is a polymer in which carbon nanotubes (CNT) are bonded with zinc oxide (ZnO), and wherein carbon nanotubes (CNT) and zinc oxide (ZnO) can be polymerized at the same ratio from each other or zinc oxide (ZnO) can have a higher ratio than carbon nanotubes (CNT), and vice versa if necessary.
- The
catheter body 100 constituting the catheter according to an embodiment of the present invention may be consisted of materials which are blended 100 parts by weight of silicon with 1.0 to 2.2 parts by weight of carbon nanotube polymer, but the combining ratio may be variable. - According to the present invention, the carbon nanotube polymer as a component of the
catheter body 100 has a constant capacitance in response to a potential in the intubated human body, so that such a capacitance is harmless to the human body, but has a galvanic effect which are deadly to bacteria and biofilms, which enable to minimizes the formation of biofilm, and the rejection of the subject during inserting process into the human body due to the high thermal conductivity which is characteristic of carbon nanotubes. - In addition, for the case of a catheter applied or coated with a conventional antibiotic, it is impossible to use the catheter for more than one week due to formation of biofilm and bacterial infection. But, the foley catheter according to the present invention can be used for at least 4 to 5 weeks due to the silicon which the carbon nanotube polymer (CNT polymer) having the above described effect is added.
- According to an embodiment of the present invention, the carbon nanotube (CNT) may be a multi-walled carbon nanotube (MWNT) since the multi-walled carbon nanotube (MWNT) has a merit to use in a solid state and is likely to be commercialized in terms of price.
- As being described above, the foley catheter and the foley for catheter according to an embodiment of the present invention may be consisted of material which a carbon nanotube polymer (CNT polymer) bonded carbon nanotubes (CNT) and zinc oxide (ZnO) as below
chemical formula 1 is combined with a silicone respectively. - In the above chemical formula (1), m, n and p represent the number of each of molecules of silicon, zinc oxide (ZnO) and carbon nanotube (CNT), m is 50 to 300, n is 7 to 30, and p is 10 to 50, but the present invention is not limited thereto.
- On the other hand, in the catheter and the foley for catheter, the above m, n, and p may be set different from each other.
- In addition, the
catheter body 100 and the foley forcatheter 200 for constituting the catheter according to an embodiment of the present invention may be a tubular tube obtained by extruding a carbon nanotube polymer (CNT) bonded carbon nanotube (CNT) and zinc oxide (ZnO) together with silicone in a predetermined ratio. - Herein, the above materials may be formed by compounding carbon nanotubes (CNT) and zinc oxide (ZnO) dispersed using a chemical vapor deposition (CVD) composite into silicon, for example, at a pressure of 1,000,000 Pa and a pressure of 50° C. for 30 minutes via dispersing process.
- Accordingly, a carbon nanotube polymer composed of carbon nanotubes (CNT) and zinc oxide (ZnO) can be uniformly inserted into the silicon, whereby the catheter and the foley for catheter made of this material can have antibacterial activity uniformly with regardless of location.
- Hereinafter, the effect for inhibiting formation of biofilm at the material constituting the foley catheter and the foley for catheter according to one embodiment of the present invention will be described with reference to
FIGS. 3 to 8 . -
FIGS. 3 to 5 show the results obtained by culturing E. coli (Escherichia coli.) which is a major pathogen of urinary tract infection, on a catheter slice composed of the above materials for 3 days, 5 days, and 7 days, and experiment of forming degree of biofilm using the crystal violet method. - With reference to
FIG. 3 , when E. coli (Escherichia coli) was cultured for 3 days, the average value of absorbance was measured with 0.303 for the blending ratio of zinc oxide (ZnO) of 0%, the average value of absorbance was measured with 0.326 for the blending ratio of zinc oxide (ZnO) of 1%, the average value of absorbance was measured with 0.252 for the blending ratio of zinc oxide (ZnO) of 2%, and the average value of absorbance was measured with 0.299 for the blending ratio of zinc oxide (ZnO) of 3%. - With reference to
FIG. 4 , when E. coli (Escherichia coli) was cultured for 5 days, the average value of absorbance was measured with 0.362 for the blending ratio of zinc oxide (ZnO) of 0%, the average value of absorbance was measured with 0.380 for the blending ratio of zinc oxide (ZnO) of 1%, the average value of absorbance was measured with 0.356 for the blending ratio of zinc oxide (ZnO) of 2%, and the average value of absorbance was measured with 0.448 for the blending ratio of zinc oxide (ZnO) of 3%. - With reference to
FIG. 5 , when E. coli (Escherichia coli) was cultured for 7 days, the average value of absorbance was measured with 0.486 for the blending ratio of zinc oxide (ZnO) of 0%, the average value of absorbance was measured with 0.425 for the blending ratio of zinc oxide (ZnO) of 1%, the average value of absorbance was measured with 0.407 for the blending ratio of zinc oxide (ZnO) of 2%, and the average value of absorbance was measured with 0.413 for the blending ratio of zinc oxide (ZnO) of 3%. -
FIG. 6 is a graph showing the results of the experiment described above with respect to the experimental materials, andFIG. 7 is a graph showing the results of the experiments described above with respect to the culturing time. - According to the experimental results shown in
FIGS. 3 to 6 , for a material in which the silicon and the carbon nanotubes (CNT) are mixed with silicon (i.e. 0% of zinc oxide (ZnO)), the average value of absorbance is rapidly increased over time, thereby formation of the biofilm is increased. - On the other hand, for a material in which 1% of zinc oxide (ZnO) is mixed with silicon and carbon nanotube (CNT), the average value of absorbance is slowly increased than that in the case of a material in which the carbon nanotubes (CNT) are mixed with silicon (i.e. 0% of zinc oxide (ZnO)), thereby formation of the biofilm is suppressed to some extent.
- In addition, for a material in which 2% of zinc oxide (ZnO) is mixed with silicon and carbon nanotube (CNT), the average value of absorbance is generally lower than that in the case of a material in which the carbon nanotubes (CNT) are mixed with silicon (i.e. 0% of zinc oxide (ZnO)) and 1% of zinc oxide (ZnO) is mixed with silicon and carbon nanotube (CNT), thereby the inhibitory effect on the biofilm formation of a major strain of urinary tract infection, E. coli (Escherichia coli.) is clearly shown.
- And, for material in which 5% of zinc oxide (ZnO) is mixed with silicon and carbon nanotube (CNT), the average value of absorbance after 7 days of culture was lower than before, resulting in an effect for inhibiting a biofilm formation according to use of long period of time.
- Based on the above experimental results, when a catheter and a foley for catheter are composed of silicon and carbon nanotube (CNT) in which zinc oxide (ZnO) is blended with about 2%, an inhibitory effect on the biofilm formation of a major strain of urinary tract infection, E. coli (Escherichia coli.) can be stably achieved.
-
FIG. 8 is a photograph of the results obtained by culturing E. coli (Escherichia coli) in a material having a zinc oxide (ZnO) blending ratio of 1% for 7 days and then taking the results of the experiment with a scanning electron microscope (SEM). - With reference to
FIG. 8 , even after 7 days of culture, it can be seen that the microorganisms, E. coli do not form a biofilm by aggregation. - Also, referring to the experimental results shown in Table 1 below, the material constituting the catheter and the foley for catheter according to an embodiment of the present invention have a bactericidal reduction rate of more than 99.9% and a bacteriostatic reduction rate for staphylococcus aureus, pneumococcus, Escherichia coli and pseudomonas aeruginosa in addition to said E. coli.
-
TABLE 1 Staphylococcus aureus (CFU/ml) Proliferation Bactericidal Bacteriostatic Initial value reduction rate reduction rate Sample NO vaccination 24 hours (F) (%) (%) name 1 3.1E+04 1.7E+06 55 — — SD BLANK 2 1.0E+01 99.97% 99.99% 3 1.0E+01 99.97% 99.99% ZnO 15 Pneumococcus (CFU/ml) Proliferation Bactericidal Bacteriostatic Initial value reduction rate reduction rate Sample NO vaccination 24 hours (F) (%) (%) name 1 2.2E+04 3.0E+06 136 — — SD BLANK 2 1.0E+01 99.95% 99.99% 3 1.0E+01 99.95% 99.99% ZnO 15 Escherichia coli (CFU/ml) Proliferation Bactericidal Bacteriostatic Initial value reduction rate reduction rate Sample NO vaccination 24 hours (F) (%) (%) name 1 2.1E+04 1.8E+06 86 — — SD BLANK 2 1.0E+01 99.95% 99.99% 3 1.0E+01 99.95% 99.99% ZnO 15 Pseudomonas aeruginosa (CFU/ml) Proliferation Bactericidal Bacteriostatic Initial value reduction rate reduction rate Sample NO vaccination 24 hours (F) (%) (%) name 1 1.2E+04 1.8E+06 150 — — SD BLANK 2 1.0E+01 99.92% 99.99% 3 1.0E+01 99.92% 99.99% ZnO 15 - On the other hand, the catheter and the foley for catheter configured as described above can minimize the patient's rejection feeling in the process of inserting the human body due to the high heat conduction characteristic of the carbon nanotube.
-
FIG. 9 is view showing experimental results for explaining an effect of reducing the foreign sensation when the materials constituting a foley catheter and a foley for catheter are inserted into the human body.FIG. 9 (a) is a thermal image of a catheter made of silicon in which carbon nanotubes do not internalized, andFIG. 9 (b) is a thermal image of a catheter made of silicon in which carbon nanotubes are internalized. - With reference to
FIGS. 9 (a) and 9 (b), it can be seen that the temperature distribution is uniform due to the high thermal conductivity in the case of a catheter composed of silicon in which carbon nanotubes are internalized. -
FIG. 10 is a drawing for explaining the configuration and operation of a foley for catheter according to an embodiment of the present invention. The descriptions for the same components as those described with reference toFIGS. 1 to 9 will be omitted herein. - Referring to
FIG. 10 , acatheter body 100 is formed with aurine inlet 11 and a foley forcatheter 200 adjacent oneend 50 of the foley for catheter that is inserted into the bladder. - The foley for
catheter 200 may expand to form a balloon when fluid (e.g., air or saline) is introduced from thefluid inlet 23 provided on the other side of the catheter. - For example, a fluid may be introduced in a manner such that a fluid is previously injected into a syringe, the syringe needle is inserted into the
inflow hole 22 at the end of thefluid inflow portion 23, and the syringe is compressed. - A foley for
catheter 200 configured to abut oneend 50 of thecatheter body 100 is inserted into the bladder, and at that state, the fluids flow from thefluid inlet 23 through thefluid passages fluid outlet 21 into the foley forcatheter 200, thereby the foley forcatheter 200 bulges in a balloon shape and spans thebladder neck 60 to secure the catheter within the bladder. - On the other hand, a
urine passage 110 connected to theurine inlet 11 is formed at the center of a cross section of thecatheter body 100 and aurine outlet 13 is formed at the end of theurine passage 110. - For example, the urine generated in the urethra is introduced into the
urine passage 110 through theurine inlet 11 located in the urethra, and then discharged via theurine outlet 12, which is the end of theurine discharging portion 13 located at outside of the urethra. -
FIG. 11 shows a drawing showing one embodiment of the configuration of a foley for catheter according to the present invention in more detail, and specifically an enlarged representation of the portion of the foley forcatheter 200 shown inFIGS. 1 and 11 where it is joined. - Referring to
FIG. 11 , bonding surfaces 210 and 211 are formed at both ends of the foley forcatheter 200 to be joined to thecatheter body 100 andbonding surfaces catheter body 100 using an adhesive during process forming the foley forcatheter 200 at thecatheter body 100. - Hereinafter, a method of manufacturing a foley catheter and a method of forming a foley for catheter according to an embodiment of the present invention will be described with reference to
FIG. 11 . - First, as being described above, a carbon nanotube polymer (CNT polymer) in which carbon nanotubes and zinc oxide (ZnO) are bonded is combined with a silicone and then is extruded into a tubular tube to form a
catheter body 100. - In addition, a carbon nanotube polymer (CNT polymer) in which carbon nanotubes and zinc oxide (ZnO) are bonded is combined with a silicone and then is extruded or molded into a tubular tube to form a foley for
catheter 200. - Herein, the mixing ratio of the carbon nanotube, zinc oxide (ZnO), or carbon nanotube polymer as a raw material for producing the
catheter body 100 and the mixing ratio of the carbon nanotube, zinc oxide (ZnO) or a carbon nanotube polymer as a raw material for producing the foley forcatheter 200 may be different. - For example, when the foley for
catheter 200 is inflated by the fluid introduced from the outside, the surface area is increased, and the distribution of the carbon nanotube polymer per unit area is decreased, and the antibacterial ability may be lowered. - As being described above, if the foley for
catheter 200 is inflated and the antibacterial ability is lowered, even if formation of biofilm is suppressed in thecatheter body 100, biofilm is formed in the foley forcatheter 200 which the antibacterial ability was lowered and then may cause bacterial infection. - According to one embodiment of the present invention, the combining ratio of the carbon nanotube polymer in the foley for
catheter 200 is preferably higher than that of the carbon nanotube polymer in thecatheter body 100. Therefore, the distribution of the carbon nanotube polymer per unit area has the same or similar range as that of thecatheter body 100 even when inflated, so that a uniform infectious power can be maintained regardless of the position of the foley forcatheter 200. - Assuming that the foley for
catheter 200 expands to increase the surface area by about 4 to 6 times, as being described above, when thecatheter body 100 is formed of a material mixed with 1.0 to 2.2 parts by weight of carbon nanotube polymer relative to 100 parts by weight of silicon, the foley forcatheter 200 may be composed of a material blended with 4.0 to 13.2 parts by weight of carbon nanotube polymer relative to 100 parts by weight of silicone in proportion to an increase in surface area. - On the other hand, for the foley for
catheter 200, it may be preferable that the values of n and m in thechemical formula 1 increase in proportion to the increase in surface area upon expansion of the foley forcatheter 200. - After the
catheter body 100 and the foley forcatheter 200 are prepared, bonding surfaces 210 and 211 of the foley forcatheter 200 are attached to thecatheter body 100 and the foley catheter can be manufactured by forming a tip provided with anurine inlet 11 at one end of thecatheter body 100. - The method of manufacturing a foley catheter and the method of forming a foley for a catheter according to an embodiment of the present invention may further include additional steps such as a drying step in addition to the steps described above and a separate step may be added.
-
FIGS. 12 to 16 are cross-sectional views showing examples of the cross sectional configuration of a foley for catheter shown inFIG. 11 . -
FIG. 12 is a cross-sectional view taken along the C-C line shown inFIG. 11 , showing a structure in which the foley forcatheter 200 covers thecatheter body 100 having theurine passage 110 and thefluid passages - Herein, when the foley for
catheter 200 is manufactured using a material having a higher mixing ratio of the carbon nanotube polymer than thecatheter body 100 as being described above, the current can flow until the potential difference is no longer present between thecatheter body 100 shown inFIG. 12 and the foley forcatheter 200. - This is because zinc oxide (ZnO) creates a high electrical potential and current flow from the foley for
catheter 200 to thecatheter body 100 at the abutting portion each other. When the potential difference is lost between thecatheter body 100 and the foley forcatheter 200, when the foley forcatheter 200 is expanded, the electrostatic capacity is lowered and the antibacterial power may be decreased. - An insulating
layer 900 is interposed between thecatheter body 100 and the foley forcatheter 200 as shown inFIG. 13 to prevent current from flowing from the foley forcatheter 200 to thecatheter body 100. - The insulating
layer 900 may be composed of a gas such as an air layer or a sterilizing gas layer (for example, EO gas), or a carbon nanotube coating layer having a high concentration. - By preventing the electric current from flowing from the foley for
catheter 200 to thecatheter body 100 by the insulatinglayer 900, a potential difference due to the difference in the mixing ratio of the carbon nanotube polymer can be maintained, thereby the antibacterial power can be maintained in the same or similar range as thecatheter body 100 even when the foley forcatheter 200 is inflated. - As being shown at
FIG. 13 , the air layer is injected into betweencatheter body 100 and the foley forcatheter 200 or an EO gas treatment or a high concentration carbon nanotube coating may be further applied to the outer surface of thecatheter body 100 during the formation of the foley forcatheter 200 so that an insulatinglayer 900 is formed between thecatheter body 100 and the foley forcatheter 200. -
FIG. 14 is a cross-sectional view taken along the line D-D shown inFIG. 11 , showing a cross-sectional structure of a portion ofbonding surface 210 where the foley forcatheter 200 is bonded to thecatheter body 100. - Referring to
FIG. 14 , an insulatingfilm 1000 may be formed on abonding surface 210 where the foley forcatheter 200 is bonded to thecatheter body 100. - This is because when the adhesive used to bond the
bonding surface 210 of the foley forcatheter 200 to thecatheter body 100 is conductive, the potential difference due to the difference in the mixing ratio of the carbon nanotube polymer causes thejunction surface 210 since the current can flow from the foley forcatheter 200 to thecatheter body 100 through the insulatingfilm 1000. - For example, the insulating
film 1000 may be formed by coating a high concentration carbon nanotube on thebonding surface 210 as a carbon nanotube insulating film, and when the foley forcatheter 200 is inflated, it may be dismantled naturally by increase of a surface area. - The insulating
film 1000 as shown inFIG. 14 is also preferably applied to a cardiovascular catheter. -
FIG. 15 is a cross-sectional view taken along the line E-E shown inFIG. 11 , showing a cross-sectional structure of a portion where thefluid outlet 21 is formed. - Referring to
FIG. 15 ,fluid outlets fluid passages catheter body 100, respectively. - Thereby, the fluid introduced from the outside flows through the
fluid passages catheter body 100 and then flows out through thefluid outlets catheter 200, and then the foley forcatheter 200 is expanded by the pressure of the fluid. -
FIG. 16 is a cross-sectional view illustrating the expanded state of the foley forcatheter 200. - Referring to
FIG. 16 , by increasing the blending ratio of the carbon nanotube polymer of the foley forcatheter 200 to the ratio of the surface area increase rate during expansion to be larger than the blending ratio of the carbon nanotube polymer of thecatheter body 100, the electrostatic capacity of the foley forcatheter 200 may be kept the same or similar to that of thecatheter body 100 when expanding so that the antibacterial power of the foley catheter can be uniform. - Although not shown separately in the drawings, the steps according to the manufacturing method may be added or reduced depending on the type or function of the catheter or the foley for catheter according to the present invention.
- Although the present invention has been particularly shown and described with reference to exemplary embodiments thereof for illustrative purposes, it is clearly understood that the same is by way of illustration and example only and is not to be construed to the preferred embodiments of the present invention, and that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanied claims.
Claims (10)
Applications Claiming Priority (13)
Application Number | Priority Date | Filing Date | Title |
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KR20160015702 | 2016-02-11 | ||
KR20160015711 | 2016-02-11 | ||
KR10-2016-0015711 | 2016-02-11 | ||
KR20160015841 | 2016-02-11 | ||
KR10-2016-0015702 | 2016-02-11 | ||
KR10-2016-0015841 | 2016-02-11 | ||
KR1020170013679A KR20170094758A (en) | 2016-02-11 | 2017-01-31 | Method of Manufacturing Composition for Catheter |
KR10-2017-0013674 | 2017-01-31 | ||
KR10-2017-0013677 | 2017-01-31 | ||
KR1020170013677A KR102082549B1 (en) | 2016-02-11 | 2017-01-31 | Composition for Catheter Foley |
KR10-2017-0013679 | 2017-01-31 | ||
KR1020170013674A KR102152574B1 (en) | 2016-02-11 | 2017-01-31 | Composition for Foley Catheter |
PCT/KR2017/001138 WO2017138716A1 (en) | 2016-02-11 | 2017-02-02 | Composition for catheter and production method therefor |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2017/001138 A-371-Of-International WO2017138716A1 (en) | 2016-02-11 | 2017-02-02 | Composition for catheter and production method therefor |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US16/991,435 Division US20200368399A1 (en) | 2016-02-11 | 2020-08-12 | Catheter, composition for catheter, production method therefor |
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Publication Number | Publication Date |
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US20190015560A1 true US20190015560A1 (en) | 2019-01-17 |
Family
ID=63220686
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US16/068,173 Abandoned US20190015560A1 (en) | 2016-02-11 | 2017-02-02 | Composition for catheter and production method therefor |
US16/991,435 Pending US20200368399A1 (en) | 2016-02-11 | 2020-08-12 | Catheter, composition for catheter, production method therefor |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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US16/991,435 Pending US20200368399A1 (en) | 2016-02-11 | 2020-08-12 | Catheter, composition for catheter, production method therefor |
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US6733513B2 (en) * | 1999-11-04 | 2004-05-11 | Advanced Bioprosthetic Surfaces, Ltd. | Balloon catheter having metal balloon and method of making same |
SE519802C2 (en) * | 2001-02-09 | 2003-04-08 | Wallsten Medical Sa | Balloon catheter for application of pressure and heat |
US20050038498A1 (en) * | 2003-04-17 | 2005-02-17 | Nanosys, Inc. | Medical device applications of nanostructured surfaces |
-
2017
- 2017-02-02 US US16/068,173 patent/US20190015560A1/en not_active Abandoned
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