REINFORCED TUBING AND METHOD OF MAKING THE SAME

A reinforced tubing comprising a shaft, a tubular body, and two or more reinforcing members is provided. The shaft has a lumen extending from a proximal port to a distal port having an inner and outer polymer layer. At least a portion of the shaft includes a tubular body and a tubular body reinforced by two or more reinforcing members. A chemical and heat treatment is performed to the two or more reinforcing members, forming an antibacterial surface thereon. A method of making a tubular body for a reinforced tubing shaft is provided. The method comprises providing two or more reinforcing members, providing a reinforced tubing mold and an extruder operatively associated therewith, attaching the two or more reinforcing members to the reinforced tubing mold, and extruding a polymer material into the reinforced tubing mold, wherein the polymer material surrounds the two or more reinforcing members forming the reinforced tubing.

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to polymer tubing, and more particularly, to reinforced tubing and method of making the same.

Description of the Related Art

Stainless steel is a low maintenance, corrosion resistant material that is widely used in a variety of industries. The alloy can be made into stainless steel plates, bars, wire, sheets and tubing, for use in manufacturing surgical instruments, appliances, cookware and cutlery, and industrial equipment etc. However, stainless steel is an inert material and is not in itself bioactive. Thus, despite being used in kitchens, food processing plants, hospitals, medical offices, surgical centers and other industries, disease-causing bacterial can form on its surfaces if not cleaned and sterilized often.

For making stainless steel antibacterial, bioavailable silver or copper atoms can be coated on the metal surface, as silver and copper are powerful bactericides. However, current techniques are complex, costly, wear off easily and can be harmful to the environment.

Food grade silicone is a non-toxic type of silicone that doesn't contain chemical fillers or byproducts. In the U.S., food grade silicone is regulated by the FDA, and in EU countries, LFGB (Germany) or DGCCRF (France) certification is often sought for commercial application. In addition to being an abundant natural resource, non-toxic and odorless, and recyclable, food grade silicone can withstand operating temperatures of between −40° Celsius to +240° Celsius.

Food grade silicone and stainless steel have been combined for use in a variety of products for a variety of industries. While both have been used for tubing, the challenges of making stainless steel antibacterial over time still remains, and additionally, bondability between stainless steel and silicone for durability and lastability is also a challenge.

There is demand for reinforced tubing and methods for making the same to solve the aforementioned problems.

BRIEF SUMMARY OF THE INVENTION

Reinforced tubing and methods of making the same are provided.

In an embodiment, a reinforced tubing comprising a shaft, a tubular body, and two or more reinforcing members is provided. The shaft is flexible and has a proximal end and distal end. The shaft also has a lumen extending from a proximal port to a distal port having an inner and outer polymer layer. In the embodiments, the inner and outer polymer layers are made of silicone. In an embodiment, at least a portion of the shaft includes a tubular body and a tubular body being reinforced by two or more reinforcing members extending laterally between the inner and outer polymer layers; however, the embodiment is not limited thereto. In alternative embodiments, portions of the tubular body have different flexibilities via the two or more reinforcing members. In the embodiments, the two or more reinforcing members are a stainless steel wire. In the embodiments, the shape of the two or more reinforcing members is cylindrical.

In the embodiments, a chemical treatment and heat treatment is performed to the two or more reinforcing members. An inorganic solvent bath is employed in the chemical treatment, forming a plurality of cavities on the outer surface of the two or more reinforcing members. In the embodiments, the ratio of inorganic solvent to water for the chemical treatment in the inorganic solvent bath forming the plurality of cavities on the outer surface of the two or more reinforcing members is in the range from 1.15:1 to 1.45:1. An antibacterial surface is formed on the two or more reinforcing members following the heat treatment. In the embodiments, the temperature of the heat treatment for forming the antibacterial surface on the outer surface of the two or more reinforcing members is in the range from 470° C. to 760° C. In the embodiments, the time period of the heat treatment for forming the antibacterial surface on the outer surface of the two or more reinforcing members is in the range 10 minutes to 60 minutes.

In an embodiment, a method of making a tubular body for a reinforced tubing shaft is provided. The reinforced tubing comprises a shaft, a tubular body, and two or more reinforcing members. In the embodiments, the method comprises providing two or more reinforcing members. In the embodiments, the two or more reinforcing members are a stainless steel wire and the shape of the two or more reinforcing members is cylindrical. Following, the surfaces of the two or more reinforcing members are cleaned and rinsed. Then, they are immersed in an inorganic solvent bath for chemical treatment. In the embodiments, the ratio of inorganic solvent to water for the chemical treatment in the inorganic solvent bath is in the range from 1.15:1 to 1.45:1. Following the chemical treatment, a plurality of cavities is formed on the two or more reinforcing members. Next, the two or more reinforcing members are rinsed and dried and prepared for heat treatment. Then, the two or more reinforcing members are heat treated. In the embodiments, the temperature of the heat treatment is in the range from 470° C. to 760° C. Following heat treatment, an antibacterial surface is formed on the two or more reinforcing members. In the embodiments, the time period of the heat treatment for forming the antibacterial surface on the outer surface of the two or more reinforcing member is in the range 10 minutes to 60 minutes.

Following, in the method of making a tubular body for a reinforced tubing shaft, a reinforced tubing mold and an extruder operatively associated with the two or more reinforcing members are provided. The two or more reinforcing members are attached to the reinforced tubing mold. Next, a polymer material with a melting temperature is extruded into the reinforced tubing mold, wherein the polymer material surrounds the two or more reinforcing members forming a lumen and an inner and outer polymer layer. In the embodiments, the inner and outer polymer layers are made of silicone. After, the tubular body is heated for bonding of the polymer material with the two or more reinforcing members. In an embodiments, the tubular body can next be cut and removed after cooling, forming the reinforced tubing for a reinforced tubing shaft.

In the embodiments of the method of making a tubular body for a reinforced tubing shaft, the shaft is flexible and has a proximal end and distal end. The lumen of the shaft extends from a proximal port to a distal port. In an embodiment, at least a portion of the shaft includes a tubular body and a tubular body being reinforced by two or more reinforcing members extending laterally between the inner and outer polymer layers; however, the embodiment is not limited thereto. In alternative embodiments, portions of the tubular body have different flexibilities via the two or more reinforcing members.

These, as well as other components, steps, features, benefits, and advantages of the present application, will now made clear by reference to the following detailed description of the embodiments, the accompanying drawings, and the claims.

DETAILED DESCRIPTION OF THE INVENTION

It is understood that the following disclosure provides many different embodiments, or examples, for implementing different features of the invention. Specific examples of devices and arrangements are described below to simplify the present disclosure. These are, of course, merely examples and are not intended to be limiting. For example, the formation of a first feature over or on a second feature in the description that follows can include embodiments in which the first and second features are formed in direct contact, and can also include embodiments in which additional features are formed between the first and second features, such that the first and second features are not in direct contact. In addition, the present disclosure can repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. It is intended that the scope of the present technology be defined by the claims appended hereto and their equivalents.

A reinforced tubing comprising a shaft, a tubular body, and two or more reinforcing members is provided. The shaft has a lumen extending from a proximal port to a distal port having an inner and outer polymer layer. At least a portion of the shaft includes a tubular body and a tubular body being reinforced by two or more reinforcing members. A chemical treatment and heat treatment is performed to the two or more reinforcing members, forming an antibacterial surface thereon. A method of making a tubular body for a reinforced tubing shaft is provided. The method comprises providing two or more reinforcing members, providing a reinforced tubing mold and an extruder operatively associated therewith, attaching the two or more reinforcing members to the reinforced tubing mold, and extruding a polymer material into the reinforced tubing mold, wherein the polymer material surrounds the two or more reinforcing members forming the reinforced tubing.

FIG. 1is a schematic perspective view illustrating a reinforced tubing having two reinforcing members according to various embodiments. As shown inFIG. 1, in an embodiment, a reinforced tubing100comprising a shaft1, a tubular body16,17,86, and two or more reinforcing members13,18is provided. The shaft1is flexible and has a proximal end12and distal end19. The shaft1also has a lumen11extending from a proximal port81to a distal port91having an inner polymer layer14and outer polymer layer15. In the embodiments, the inner and outer polymer layers14,15, respectively, are made of silicone, for example, and not to be limiting, food grade silicone; however, the embodiments are not limited thereto. Other biodegradable polymer materials with a melting temperature can be employed. In an embodiment, at least a portion of the shaft1includes a tubular body16,17and a tubular body86being reinforced by two or more reinforcing members13,18extending laterally between the inner and outer polymer layers14,15; however, the embodiment is not limited thereto. In alternative embodiments, portions of the tubular body can have different flexibilities via the two or more reinforcing members13,18or similar flexibilities.

FIG. 2is a schematic perspective view illustrating an alternative reinforced tubing having two reinforcing members according to various embodiments. As shown inFIG. 2, in an alternative embodiment, a reinforced tubing200comprising a shaft2, a tubular body96, and two or more reinforcing members23,28is provided. The shaft2is flexible and has a proximal end22and distal end29. The shaft2also has a lumen21extending from a proximal port82to a distal port92having an inner polymer layer24and outer polymer layer25.

In the embodiments, the two or more reinforcing members13,18,23,28are stainless steel wires. As an example, and not to be limiting, the stainless steel wire can comprise 50 wt % or more of iron, 12 wt % or more of chromium and 2 to 4 wt % of copper, among other elements. In the embodiments, the shape of the two or more reinforcing members13,18,23,28is cylindrical and the outer surface diameter thereof is less than a perpendicular distance between the inner polymer and outer polymer layer14,24and15,25, respectively. In the embodiments, the diameter of the lumen11,21is greater than the outer surface diameter of the two or more reinforcing members13,18,23,28.

As an example, and not to be limiting, the two or more reinforcing members13,18,23,28comprise a flexural rigidity and a Young's modulus higher than that of the lumen11of the shaft1having an inner polymer layer14and outer polymer layer15made of silicone, as an example, and not to be limiting, for flexibility and fixing. The structural design allows the reinforced tubing to be oriented and fixed in any direction. As an example, and not to be limiting, oriented and fixed in any angular direction and/or circular direction via twisting, etc.

FIG. 3is a schematic cross-sectional view illustrating the reinforced tubing ofFIG. 2having two reinforcing members according to various embodiments.FIG. 4is a schematic enlarged cross-sectional view illustrating a reinforcing member according to various embodiments.FIG. 5is a schematic longitudinal cross-sectional view illustrating a reinforcing member according to various embodiments. As shown inFIGS. 3 to 5, and referring again toFIG. 2, in the embodiments, a chemical treatment and heat treatment is performed to the two or more reinforcing members23,28. An inorganic solvent bath is employed in the chemical treatment, forming a plurality of cavities42on the outer surface of the two or more reinforcing members23,28. In the embodiments, as an example, and not to be limiting, the ratio of inorganic solvent to water for the chemical treatment in the inorganic solvent bath forming the plurality of cavities42on the outer surface of the two or more reinforcing members23,28can range from 1.15:1 to 1.45:1.

As an example, and not to be limiting, in the embodiments, the chemical treatment and the inorganic solvent bath forming the plurality of cavities42, can be any chemical treatment and inorganic solvent bath known to those skilled in the art for removing contaminants and forming a chromium rich and uniform passive layer. For example, and not to be limiting, the inorganic solvent bath can comprise hydrochloric acid HCl, sulfuric acid H2SO4, nitric acid HNO3, phosphoric acid H3PO4, boric acid H3BO3, hydrofluoric acid HF, hydrobromic acid HBr, perchloric acid HClO4, or the like. So long as contaminants can be removed from, and the plurality of cavities42can be formed on, the outer surface of the two or more reinforcing members, forming a chromium rich and uniform passive layer.

An antibacterial surface41is formed on the two or more reinforcing members23,28, including the plurality of cavities42, following the heat treatment. In the embodiments, as an example, and not to be limiting, the temperature of the heat treatment for forming the antibacterial surface41on the outer surface of the two or more reinforcing members, including the plurality of cavities42, can range from 470° C. to 760° C.; however, the embodiments are not limited thereto. The temperature of the heat treatment for forming the antibacterial surface41on the outer surface of the two or more reinforcing members, including the plurality of cavities42, can range from 470° C. to 630° C., or from 540° C. to 590° C.

In the embodiments, as an example, and not to be limiting, the time period of the heat treatment for forming the antibacterial surface on the outer surface of the two or more reinforcing members, including the plurality of cavities42can range from 10 minutes to 60 minutes.

As an example, and not to be limiting, the antibacterial surface41of the two or more reinforcing members23,28of the embodiments is formed by balanced formation of chromium and copper and other elements throughout the two or more reinforcing members23,28, including surfaces thereof. Copper(II) oxide is formed when the copper at the surface of the two or more reinforcing members23,28reacts with oxygen. Copper ions released from the surfaces of the two or more reinforcing members23,28can combine with proteins by electrostatic force to deform bacterial membrane, providing an antibacterial surface41having preventive corrosion properties. Following release of the copper ions, due to the balanced formation of copper throughout the two or more reinforcing members23,28, balance and stability remains, providing antibacterial surface regeneration properties.

FIG. 6is a schematic cross-sectional view illustrating an extruder and reinforced tubing mold according to various embodiments.FIG. 7is a schematic cross-sectional enlarged view illustrating the outlet A of the extruder and reinforced tubing mold ofFIG. 6according to various embodiments.FIG. 8is a flow chart illustrating a method of making a tubular body for a reinforced tubing shaft according to various embodiments. As shown inFIGS. 6 to 8, and referring again toFIG. 2. In an embodiment, a method1000of making a tubular body200for a reinforced tubing shaft is provided. The reinforced tubing200comprises a shaft2, a tubular body96, and two or more reinforcing members23,28. In the embodiments, in Step1110, the method1000comprises providing two or more reinforcing members23,28.

In the embodiments, as an example, and not to be limiting, the two or more reinforcing members23,28are stainless steel wires and the shape thereof is cylindrical. As an example, and not to be limiting, the stainless steel wire can comprise 50 wt % or more of iron, 12 wt % or more of chromium and 2 to 4 wt % of copper, among other elements.

Following, in Step1120, the surfaces of the two or more reinforcing members23,28are cleaned and rinsed. Then, in step1130, they are immersed in an inorganic solvent bath for chemical treatment. In the embodiments, the ratio of inorganic solvent to water for the chemical treatment in the inorganic solvent bath is in the range from 1.15:1 to 1.45:1.

As an example, and not to be limiting, in the embodiments, the chemical treatment and the inorganic solvent bath forming the plurality of cavities42, can be any chemical treatment and inorganic solvent bath known to those skilled in the art for removing contaminants and forming a chromium rich and uniform passive layer. For example, and not to be limiting, the inorganic solvent bath can comprise hydrochloric acid HCl, sulfuric acid H2SO4, nitric acid HNO3, phosphoric acid H3PO4, boric acid H3BO3, hydrofluoric acid HF, hydrobromic acid HBr, perchloric acid HClO4, or the like. So long as contaminants can be removed from, and the plurality of cavities42can be formed on, the outer surface of the two or more reinforcing members, forming a chromium rich and uniform passive layer.

Following the chemical treatment, a plurality of cavities42is formed on the two or more reinforcing members23,28. Next, in Step1140, the two or more reinforcing members23,28are rinsed and dried and prepared for heat treatment. Then, in Step1150, the two or more reinforcing members23,28are heat treated.

In the embodiments, the temperature of the heat treatment is in the range from 470° C. to 760° C.; however, the embodiments are not limited thereto. The temperature of the heat treatment for forming the antibacterial surface41on the outer surface of the two or more reinforcing members, including the plurality of cavities42, can range from 470° C. to 630° C., or from 540° C. to 590° C. Following heat treatment, an antibacterial surface is formed on the two or more reinforcing members23,28, including the plurality of cavities42. In the embodiments, the time period of the heat treatment for forming the antibacterial surface on the outer surface of the two or more reinforcing members23,28, including the plurality of cavities42, is in the range 10 minutes to 60 minutes.

As an example, and not to be limiting, the antibacterial surface41of the two or more reinforcing members23,28of the embodiments is formed by balanced formation of chromium and copper and other elements throughout the two or more reinforcing members23,28, including surfaces thereof. Copper(II) oxide is formed when the copper at the surface of the two or more reinforcing members23,28reacts with oxygen. Copper ions released from the surfaces of the two or more reinforcing members23,28can combine with proteins by electrostatic force to deform bacterial membrane, providing an antibacterial surface41having preventive corrosion properties. Following release of the copper ions, due to the balanced formation of copper throughout the two or more reinforcing members23,28, balance and stability remains, providing antibacterial surface regeneration properties.

Following, in the method of making a tubular body for a reinforced tubing shaft, in Step1210, a reinforced tubing mold8and an extruder61operatively associated with the two or more reinforcing members23,28are provided. As an example, and not to be limiting, the extruder61can comprise a receiving end66, a hopper63, a barrel61, a screw64, and a motor65, extruding a polymer material with a melting temperature into the reinforced tubing mold8.

After, in Step1220, the two or more reinforcing members23,28are attached to the reinforced tubing mold8. As an example, and not to be limiting, the reinforced tubing mold8can comprise a distributive splitting channel81and a plug82, and be operatively attached to a receiving mold71having one or more funneled sections72for funneling of the polymer material with a melting temperature.

Next, in Step1230, a polymer material with a melting temperature is extruded into a distributive splitting channel81of the reinforced tubing mold8, wherein the polymer material surrounds the two or more reinforcing members23,28forming a lumen21and an inner polymer layer24and outer polymer layer25. In the embodiments, the inner polymer layer24and outer polymer layer25are made of silicone, for example, and not to be limiting, food grade silicone; however, the embodiments are not limited thereto. Other biodegradable polymer materials with a melting temperature can be employed.

After, in Step1240, the tubular body is heated for bonding of the polymer material with the two or more reinforcing members23,28. In the embodiments, in Step1250and Step1260, the tubular body can next be cut and removed after cooling, forming the reinforced tubing for a reinforced tubing shaft.

In the embodiments of the method of making a tubular body for a reinforced tubing shaft, the shaft2is flexible and has a proximal end22and distal end29. The lumen21of the shaft2extends from a proximal port82to a distal port92. In an embodiment, at least a portion of the shaft includes a tubular body and a tubular body being reinforced by two or more reinforcing members23,28extending laterally between the inner and outer polymer layers24,25; however, the embodiment is not limited thereto. In alternative embodiments, portions of the tubular body96have different flexibilities via the two or more reinforcing members23,28.

As an example, and not to be limiting, the outer surface diameter of the two or more reinforcing members23,28is less than a perpendicular distance between the inner polymer and outer polymer layer24,25, respectively. In the embodiments, the diameter of the lumen21is greater than the outer surface diameter of the two or more reinforcing members23,28.

As an example, and not to be limiting, the two or more reinforcing members23,28comprise a flexural rigidity and a Young's modulus higher than that of the lumen21of the shaft2having an inner polymer layer24and outer polymer layer25made of silicone, as an example, and not to be limiting, for flexibility and fixing. The structural design allows the reinforced tubing to be oriented and fixed in any direction. As an example, and not to be limiting, oriented and fixed in any angular direction and/or circular direction via twisting, etc.

Stainless steel is a low maintenance, corrosion resistant material that is widely used in a variety of industries. The alloy can be made into stainless steel plates, bars, wire, sheets and tubing, for use in manufacturing surgical instruments, appliances, cookware and cutlery, and industrial equipment etc. However, stainless steel is an inert material and is not in itself bioactive. Thus, despite being used in kitchens, food processing plants, hospitals, medical offices, surgical centers and other industries, disease-causing bacterial can form on its surfaces if not cleaned and sterilized often.

For making stainless steel antibacterial, bioavailable silver or copper atoms can be coated on the metal surface, as silver and copper are powerful bactericides. However, current techniques are complex, costly, wear off easily and can be harmful to the environment.

Food grade silicone is a non-toxic type of silicone that doesn't contain chemical fillers or byproducts. In the U.S., food grade silicone is regulated by the FDA, and in EU countries, LFGB (Germany) or DGCCRF (France) certification is often sought for commercial application. In addition to being an abundant natural resource, non-toxic and odorless, and recyclable, food grade silicone can withstand operating temperatures of between −40° Celsius to +240° Celsius.

Food grade silicone and stainless steel have been combined for use in a variety of products for a variety of industries. While both have been used for tubing, the challenges of making stainless steel antibacterial over time still remains, and additionally, bondability between stainless steel and silicone for durability and lastability is also a challenge.

The reinforced tubing of the embodiments comprises a shaft, a tubular body, and two or more reinforcing members. The shaft has a lumen extending from a proximal port to a distal port having an inner and outer polymer layer. At least a portion of the shaft includes a tubular body and a tubular body being reinforced by two or more reinforcing members. A chemical treatment and heat treatment is performed to the two or more reinforcing members, forming an antibacterial surface thereon. The reinforced tubing of the embodiments employ two or more stainless steel wires, surrounded by food grade silicone, allowing the reinforced tubing to be oriented and fixed in any angular direction and/or circular direction via twisting, etc. Also, the two or more stainless steel wires have a chromium rich and uniform passive layer following the chemical treatment, providing preventative corrosion properties thereto. In addition, in part to the composition of the two or more stainless steel wires and chemical and heat treatments performed thereto, the copper element therein is formed having balance and stability. Thus, following release of copper ions associated with the antibacterial properties thereof, balance and stability remains, providing antibacterial surface regeneration properties, making the antibacterial properties of the stainless steel last longer over time. Moreover, bondability between the two or more stainless steel wires and food grade silicone is strong via the plurality of cavities and the reinforced tubing of the embodiments is durable via the method of making the tubular body for the reinforced tubing shaft.

Those skilled in the art will appreciate that additional steps may be added to the process in order to incorporate additional features into the finished product. Also, the steps can be altered depending upon different requirements. Those skilled in the art will also appreciate that additional coatings, treatments, etc., as can be common with medical devices, sanitary equipment and industrial equipment etc., can be applied to the reinforced tubing.

The details of the construction or composition of the various elements of the reinforced tubing of the embodiments not otherwise disclosed are not believed to be critical to the present invention, so long as the recited elements poses the strength or mechanical properties needed for them to perform as disclosed. Additional details of construction are believed to be well within the ability of one of ordinary skill in the art.

Unless otherwise indicated, all numbers used herein to express quantities, dimensions, and so forth used should be understood as being modified in all instances by the term “about.” The use of the singular includes the plural unless specifically stated otherwise, and use of the terms “and” and “or” means “and/or” unless otherwise indicated.

From the foregoing it will be appreciated that, although specific embodiments have been described herein for purposes of illustration, various modifications can be made without deviating from the spirit and scope of the disclosure. Furthermore, where an alternative is disclosed for a particular embodiment, this alternative can also apply to other embodiments even if not specifically stated.