Catheter assembly and related methods

Abstract

The present application relates to catheter assemblies and related methods. An intravenous catheter device or apparatus (100) includes a catheter hub (110), a kink-resistant catheter tube (150), a needle (101), and a needle hub (103). The catheter tube (150) includes a catheter body (151) having a lumen (156), an outer circumference, and a wall thickness between the lumen and the outer circumference or between an outer surface (158) and an inner surface (137). The catheter body (151) can have at least two different portions made of two different materials having two different stiffness properties. A first portion (152) can be made of a first material and a second portion (155) can be made of a second material, and wherein the stiffness of the second material can be greater than the stiffness of the first material.

Description

Technical Field

[0001] This disclosure generally relates to intravenous catheter devices, apparatuses, and assemblies (IVCs) including peripheral and central venous catheter components, and more particularly to IVCs having catheter bodies, each catheter body characterized by a reinforcing region to help the catheter body resist kinking while maintaining flexibility, and related methods. This application is a divisional application, with parent application number 201980041455.9, filed on April 15, 2019, entitled "Catheter Assembly and Related Methods". Background Technology

[0002] IVCs are common invasive medical devices routinely used for a variety of infusion therapies, including infusing fluids into a patient, aspirating blood from a patient, or monitoring various parameters of a patient's vascular system. Access to the patient's vascular system is typically achieved by inserting a catheter body (a procedure known as venipuncture). IV catheter bodies are inserted into the majority of hospitalized patients during their hospital stay and are frequently initiated in many emergency situations.

[0003] The insertion of an IVC involves four basic steps: (1) the healthcare professional inserts the needle and catheter body together into the patient's vein; (2) after the needle tip is inserted into the vein, the healthcare professional pushes the catheter body forward into the patient's vein using his or her fingers; (3) the healthcare professional grasps the hub (opposite to the tip) to withdraw the needle while simultaneously applying pressure to the patient's skin at the insertion site with his or her other hand to slow or stop blood flow through the catheter body; and (4) the healthcare professional then tapes the exposed end of the catheter body and / or the catheter hub to the patient's skin and connects it to the fluid source to be administered into the patient's vein. Because a portion of the catheter body remains inside the patient, patient comfort and safety are affected by the flexibility, size (e.g., diameter), and material selection of the catheter body. In IVC cases requiring a longer catheter body, the additional length for a given diameter necessitates a larger diameter or more rigid catheter body to prevent kinking as it advances deeper into the vein after venipuncture. A larger diameter catheter body requires a larger opening at the insertion site, and therefore a larger needle, which causes additional pain and discomfort associated with using a larger needle. Additionally, a larger opening at the insertion site increases the risk of infection and prolongs wound healing time. A larger diameter catheter body may also obstruct a larger portion of the vein's inner diameter. Following venipuncture, the increased rigidity of the catheter body can potentially cause damage to the venous valves and vein walls as it is fed into the desired location. Furthermore, a more rigid catheter body causes additional discomfort and pain at the insertion site, which may lead to further complications for the patient and delay recovery. Summary of the Invention

[0004] The various aspects of the intravenous catheter assembly and catheter body have several features, none of which individually is solely responsible for its desired properties. Without limiting the scope of the embodiments set forth in the following claims, its more prominent features will now be briefly discussed.

[0005] This disclosure includes aspects of an intravenous catheter assembly and related methods for forming the intravenous catheter assembly, the intravenous catheter assembly comprising at least one catheter body having at least one ridge. The intravenous catheter assembly may be a needle device or a component or sub-assembly beyond a needle catheter assembly.

[0006] The catheter body described herein can be used with the catheter hub described herein and can form part of the catheter assembly described herein.

[0007] The ridge can be understood as a reinforcement, as its inclusion strengthens that portion of the tube body to prevent or limit kinking to the conduit material. The ridge may have a strip with a surface and a cross-sectional profile having a regular or irregular area, such as an elliptical, square, circular, rhomboid, polygonal, or irregular shape. The ridge may have a length that extends along the full length of the conduit body, or it may have a length that does not extend along the full length of the conduit body, such as a slight indentation from the distal opening of the conduit body.

[0008] The catheter body may include a catheter body composed of a first flexible portion and a second flexible portion, wherein the second flexible portion is more rigid than the first flexible portion.

[0009] Another aspect of this disclosure is a catheter device comprising: a catheter hub having a catheter body attached thereto; a needle having a needle tip attached to the needle hub and the needle protruding through the catheter body, wherein the needle tip protrudes distally toward a distal opening of the catheter body; the catheter body may include a catheter body having a wall, the catheter body having an outer surface, an inner surface, a wall thickness between the outer surface and the inner surface, and an inner lumen defined by the inner surface.

[0010] The catheter body may include: a first portion having a wall thickness formed of a first material having a first stiffness property, the first portion having an inner surface and an outer surface, the inner surface forming at least a portion of the inner lumen and the inner surface of the catheter body, and the outer surface forming at least a portion of the outer surface of the catheter body; and a second portion having a wall thickness formed of a second material having a second stiffness property, the second portion having an inner surface and an outer surface. The second stiffness property of the second material may be greater than the first stiffness property of the first material.

[0011] The second part may be embedded within the wall thickness of the catheter body, or it may not be embedded within the wall thickness of the catheter body. When the second part is embedded within the wall thickness of the catheter body, it should be understood that the outer surface or external surface of the second part is enclosed by the wall thickness of the catheter body, or is enclosed by the first part. When the second part is not embedded within the wall thickness of the catheter body, it should be understood that the external surface, internal surface, or both external and internal surfaces of the second part are exposed and not covered by the wall thickness of the catheter body, or are not covered by the first part.

[0012] When the second part is not embedded in the wall thickness of the catheter body, (i) the inner surface of the second part forms another part of the inner lumen and the inner surface of the catheter body, (ii) the outer surface of the second part forms another part of the outer surface of the catheter body, or (iii) the inner surface of the second part forms another part of the inner lumen and the inner surface of the catheter body, and the outer surface of the second part forms another part of the outer surface of the catheter body.

[0013] The second part may have a cross-sectional profile of a certain width, which is approximately constant along the length of the conduit body. When the material of the second part is more rigid than that of the first part, the second part may be a ridge or a reinforcement.

[0014] The second part may also have a surface that extends longitudinally or along the length of the conduit body.

[0015] The length of the catheter body can range from about 1.4 cm to about 6.4 cm or from about 8 cm to about 12 cm.

[0016] The distal end of the catheter body may be tapered.

[0017] The first material may include polyurethane (PUR) and may have a stiffness property lower than that of the second stiffness property.

[0018] The material may include fluorinated ethylene propylene (FEP) and may have a stiffness property lower than that of the second stiffness property.

[0019] The first material may include polyether block amide (PEBA) and may have a stiffness property lower than that of the second stiffness property.

[0020] The second material can be barium sulfate (BaSO4).

[0021] The second material can be alternatively made of PEEK or PROPELL. TM Made.

[0022] In other examples, the second material used to manufacture the second part or ridge may be basic bismuth carbonate (Bi2O2CO3) or bismuth oxychloride (BiOCl).

[0023] The second material can be fluorinated ethylene propylene (FEP), and the first material has low stiffness properties. The first material can be PUR.

[0024] The first and second parts can extend from the distal opening of the catheter body or very close to the distal opening of the catheter body toward the proximal end of the catheter body.

[0025] The catheter body may have three strips with spaced-apart ridges, each strip having a stiffness property greater than the first stiffness property used to form the catheter body.

[0026] The second part may be the first ridge, and the tube body may further include a second ridge spaced apart from the first ridge.

[0027] The second part may have a cross-sectional profile of a certain width, which increases from the distal end to the proximal end along the length of the duct body.

[0028] The needle protector may be provided with a conduit hub having a surface configured to cover the needle tip. For example, the needle protector may have a surface positioned to one side of the needle in a ready-to-use position, and wherein the surface of the needle protector is movable distal to the needle tip in a protected position to cover the needle tip in case of accidental needle puncture.

[0029] The needle protector can be positioned within the lumen of the catheter hub in the ready position.

[0030] A needle protector may include a proximal wall and two arms extending distal to the proximal wall. These two arms may intersect each other in a ready-to-use position and a protected position.

[0031] The second part may include two or more spaced-apart ridges.

[0032] The two or more spaced-apart ridges can be embedded within the wall thickness of the conduit body.

[0033] The two or more spaced-apart ridges may not be embedded within the wall thickness of the conduit body.

[0034] At least one ridge may be embedded within the wall thickness of the catheter body, and at least one ridge may not be embedded within the wall thickness of the catheter body.

[0035] The catheter body described herein can be used with an extended needle assembly for catheterization to reduce or minimize kinking by utilizing at least one strip or ridge together with the tube body, the strip or ridge being more rigid than the rest of the tube body, and the use of the tube body with the at least one ridge can be performed when X-rays are not involved or when visual inspection of the catheter body is not required or demanded.

[0036] The catheter body described herein can be used with an extended needle assembly for catheterization to reduce or minimize kinking by utilizing at least one strip or ridge along with the catheter body, which is more rigid than the remainder of the catheter body along its length, which is longer than a standard catheter body. For example, a catheter body having a catheter body as described as having at least one ridge can have a length from about 8 cm to about 12 cm, which is longer than a standard catheter body having a length from about 1.4 cm to about 6.4 cm. However, a catheter body having a catheter body as described as having at least one ridge can have a standard catheter body length from about 1.4 cm to about 6.4 cm.

[0037] The invention further includes a method of forming a catheter assembly. The method may include: forming a catheter hub having a catheter body attached thereto; forming a needle hub having a needle tip, and causing the needle to protrude through the catheter body, wherein the needle tip protrudes distally to a distal opening of the catheter body.

[0038] The catheter body may include a catheter body with a wall, having an outer surface, an inner surface, a wall thickness between the outer and inner surfaces, and an inner lumen defined by the inner surface.

[0039] Further aspects of the invention include a method of using a catheter assembly having a catheter body having anti-kink properties. The method of use may include: placing the catheter body into a vein, the catheter body being attached to a catheter hub; and wherein the catheter body includes a catheter body having a wall, the catheter body having an outer surface, an inner surface, a wall thickness between the outer and inner surfaces, and a lumen defined by the inner surface.

[0040] An intravenous catheter device or apparatus in the ready position allows the needle tip to extend distal to the catheter body for venous puncture. Throughout this disclosure, the catheter device or apparatus may be interchangeably referred to as an extended-needle catheter device or a needle device.

[0041] The catheter device or apparatus may include: a needle having a needle tip connected to a needle hub; a catheter hub including a hub body defining an inner lumen; and a catheter body extending distally to the catheter hub.

[0042] The needle hub can be directly coupled to or in contact with the proximal end of the catheter hub. In other examples, the needle hub can be indirectly coupled to the proximal end of the catheter hub via an intermediate hub (not shown). For example, a third hub, as shown in Figures 13 and 14 of U.S. Patent No. 8,591,468, can be positioned between the catheter hub and the needle hub, with the needle hub spaced apart from the catheter hub. For all purposes, the contents of the '468 patent are expressly incorporated herein by reference.

[0043] In the preparatory position, before the catheter body is inserted into the patient's vein, a needle with a needle tip may protrude through the lumen or orifice of the catheter body. The needle tip may have a bevel, which is either facing away from the patient's skin or upwards during venous puncture. The upward-facing bevel of the needle tip may be oriented in the same manner as the upper portion of the catheter hub body and away from the lower portion facing the patient's skin.

[0044] The needle can protrude through the lumen of the catheter body and form a seal with the distal opening at the distal end of the catheter body to prevent blood from flowing through the annular space between the catheter body and the outside of the needle after a successful venipuncture.

[0045] The distal end of the catheter body tapers inward, and the opening forms a tight fit around the needle, so that when the needle and catheter body are inserted into the patient's body, the catheter body will not snag on any tissue, such as the skin or vein wall, during the insertion of the needle into the vein.

[0046] When the needle pierces the wall of a patient's vein and enters the vein, blood flows through the needle into the needle hub. Blood can then flow into the lumen of the needle hub and / or into a blood collection device or vent plug located proximal to the hub. This is called primary reflux, and it is used to indicate appropriate venous access.

[0047] The needle protector 104 can be positioned inside the cavity of the catheter hub. In the example, the needle protector can be a clip type that is mounted on the needle and can slide on the needle to cover the needle tip. Alternatively, the needle protector can be positioned in a third housing located between the needle hub and the catheter hub, as previously described.

[0048] In another example, the needle protector may be of a retractable type, retracting the needle and needle tip into a protective housing, with or without a spring. In still other examples, the needle protector is of a type that allows the barrel or sheath to move over the needle tip. When the needle protector is of a clip type, a contour-changing portion (such as a pleat or ridge) may be incorporated proximal to the needle tip to engage the enclosure defining the opening on the needle protector. In other examples, a tether may be used instead of a contour-changing portion to prevent the needle protector from displaced distally away from the needle. An exemplary catheter assembly is shown in U.S. Patent No. 8,333,735, the contents of which are expressly incorporated herein by reference.

[0049] In other examples, the valve and valve opener may be positioned inside the catheter hub to restrict blood flow from a proximal opening in the hub body after successful venipuncture and removal of the needle and needle hub from the catheter hub. The valve may have one or more slits defining one or more flaps. By inserting the tip of a male Luer element into the catheter hub to push the valve opener distally, the valve opener can be advanced distally into the valve to open it. Aspects of the valve and valve opener are discussed in U.S. Patent No. 8,333,735, which is previously incorporated herein by reference. The valve and valve opener are also described in U.S. Publication No. 2018 / 0214673, the contents of which are expressly incorporated herein by reference.

[0050] The catheter hub may include a tab positioned on the upper portion of the catheter hub. This tab can function as a lever during insertion and / or removal of the needle and needle hub. The tab may be located at the “upper portion” of the catheter hub, which can be understood as facing away from the skin when used with or on the patient. A registration groove may be located on the catheter hub opposite the tab or positioned opposite the tab using the catheter hub. The registration groove may be configured to receive ribs or protrusions on the needle hub to facilitate alignment and orientation of the needle and needle hub with the catheter hub. The registration groove may be located at the external threads of the catheter hub. If the tab is omitted, the upper portion is understood as the portion facing upwards or away from the patient's skin.

[0051] The conduit hub may have a hub body and an inner cavity defined by the wall surface of the hub body. The conduit hub may further include a conduit tube in fluid communication with the inner cavity of the hub body.

[0052] Using conventional means (such as a metal bushing), the conduit body can be attached to a distal section of the hub body. The metal bushing can act as a wedge to secure the proximal end of the conduit body to the hub body. In other embodiments, the conduit body can communicate with the interior of the hub body and a fluid port extending from one side of the hub body.

[0053] If a fluid port is incorporated, a flexible valve, typically in a cylindrical configuration, can be located inside the conduit hub to control fluid flow through the fluid port. The fluid port can extend at an angle from or perpendicular to the axis of the hub body. The hub body may have a proximal inlet in a proximal section and a female Luer element tapered portion for receiving a male Luer element tip, such as a male infusion line, syringe, or male Luer element adapter. The proximal section may also include external threads for secure engagement with threads on a male Luer element locking fitting or syringe tip (also known as a Luer element lock).

[0054] The catheter hub may also include a tab positioned on the hub body (between the proximal and distal segments of the hub body) to aid in clamping and / or guiding the needle device when it is inserted into a patient's vein. Hereinafter, the upper portion of the catheter hub or hub body may be understood to refer to the location of the tab. Further, the upper portion is understood to mean, along the elevation-wise, the portion of the catheter hub, catheter device, or hub body above a pair of wings or above a lower hub portion configured to contact the patient's skin.

[0055] In the ready-to-use position, the needle device should be positioned with the bevel of the needle tip facing upwards (e.g., if the catheter hub extends directly onto the bevel, it should be arranged in a similar orientation to the upper portion of the catheter hub) and away from the patient's skin. The tab can be used as a reference point to orient the needle device relative to the patient's skin and the puncture site.

[0056] With the bevel of the needle oriented in the same upward direction as the upper part of the catheter hub (where the tab is located), the position of the tab can be used as an indicator of the position of the bevel when the needle device is inserted into the patient's vein, and when the catheter hub is installed and secured to the patient after a successful venous puncture.

[0057] The tab can have a rectangular shape with smooth edges. However, the tab can be of any shape and thickness, as long as there is sufficient rigidity to provide a leverage point for the user to push against. Grooves or small protrusions can be formed on the surface of the tab to help clamp or hold it. The position of the tab can also be used to indicate reinforced areas of the conduit body, such as the upper part of the tube body.

[0058] A pair of wings may extend laterally across the hub body to provide additional surface areas for supporting the catheter hub against the patient. In some embodiments, the catheter hub may also be equipped with a diaphragm or valve (not shown) located inside the lumen of the hub body or near the proximal inlet of the hub body to restrict or constrain fluid flow across the catheter hub.

[0059] The catheter body may include a catheter body or tube body having an outer or outer surface and an inner or inner surface defining an inner lumen. The inner lumen may be in fluid communication with a catheter hub, such as with the inner lumen of a catheter hub. The tube body may have a wall thickness between the outer and inner surfaces.

[0060] The diameter of the catheter lumen can be large enough to surround the needle and to deliver fluid to and / or from the patient at the desired flow rate after successful venipuncture. The inner diameter or lumen of the catheter at the distal end is slightly larger than the diameter of the needle. The catheter body may have a tapered portion at the distal end or distal tip, and the proximal end may be connected to the catheter body indirectly or directly by, for example, a metal sheath or some other attachment means (such as adhesive).

[0061] The catheter body may have a wall thickness between its outer surface or outer boundary and the inner surface defining the catheter lumen. The wall thickness may be constant along the length of the catheter body proximal to the tapering portion and decrease towards the distal end of the catheter body at the tapering portion. In other words, the diameter of the outer surface of the catheter body may be substantially the same along the length of the catheter body proximal to the tapering portion and decrease towards the distal end of the catheter body at the tapering portion.

[0062] A distal lumen opening or distal opening is defined at the distal end of the catheter body. In an embodiment, the diameter of the distal lumen opening is smaller than the nominal diameter of the catheter lumen, such that the distal opening at the distal end has a form fit around the needle. The distal end may have a seal around the needle axis. The distal lumen opening may be slightly smaller than the diameter of the needle to form a seal with the needle. When the needle is removed after successful venous puncture or when the needle is moved proximally such that at least a portion of the bevel is within the lumen, the seal between the distal lumen opening and the needle can be terminated to allow blood to flow into the catheter lumen, thereby indicating that the catheter body has successfully penetrated the vein and provided access to the patient's vascular system. This is referred to as secondary flashback.

[0063] The catheter body may include a first portion formed of a first material and a second portion formed of a second material, the first and second portions being joined together to form a tubular structure. The tubular structure formed of the catheter body having at least the first and second portions may have a uniform outer surface and a uniform inner surface. Both the first and second materials may be flexible. However, the second material may be harder or more rigid than the first material. For example, the stiffness property of the second material may be higher than that of the first material.

[0064] Both the first part made of the first material and the second part made of the second material can each be formed into an arcuate structure with a concave inner surface and a convex outer surface. However, the sides of the first and second parts can have any shape, such that the overall shape of the first and second parts can also have any shape other than having arcuate inner and outer surfaces.

[0065] The lengths of the first and second parts can extend parallel to the axis of the catheter body. The sides of the first part can connect to the sides of the second part to collaboratively form the catheter body. That is, both the first part, made of a first material, and the second part, made of a second material (different from the first material), can extend longitudinally side-by-side and parallel to the axis of the catheter body.

[0066] The concave inner surface of the first part and the concave inner surface of the second part can together form the inner lumen of the catheter, and the convex outer surface of the first part and the convex outer surface of the second part can together form the outer surface or outer boundary of the catheter body.

[0067] In other examples, there may be multiple first parts and multiple second parts that are connected together to form the conduit body of the present invention.

[0068] In some embodiments, the concave inner surface of the second portion and the convex surface of the second portion, both made of the second material, form the catheter lumen and the outer surface of the catheter body, respectively, while the first portion, made of the first material, is embedded within the inner and outer surfaces of the second portion (e.g., within the wall thickness). In other embodiments, the concave inner surface of the first portion and the convex surface of the first portion, both made of the first material, form the catheter lumen and the outer surface of the catheter body, respectively, while the second portion, made of the second material, is embedded within the inner and outer surfaces of the first portion (e.g., within the wall thickness).

[0069] The stiffness (k) of the second part made of the second material can be greater than the stiffness of the first part made of the first material. Therefore, when the catheter body has both the first and second parts, the second part forms a region of the catheter body that is more rigid than one or more other parts of the catheter body not made of the second material. Since the reinforcing region of the catheter body is formed by the second part, the overall stiffness of the catheter body can be increased compared to a catheter body made entirely of the first material. Therefore, the elastic modulus or Young's modulus (E) of the catheter body, proportional to its stiffness, is also greater than that of a catheter body without a reinforcing region or (in the case where the catheter body is entirely made of the same first material) without at least one strip of material with relatively greater stiffness.

[0070] The shape of the second part can also affect the overall stiffness of the catheter body. For example, the overall stiffness of the catheter body can be increased by increasing the moment of inertia of the second part. In the example, this can be achieved by increasing the cross-sectional area of ​​the ridge or by changing the shape of the ridge. When the stiffness of the second part increases, the overall elastic modulus of the catheter body can increase. Again, the stiffness of the second part can be increased by changing its shape and / or width.

[0071] Increased stiffness of the catheter body can require greater force to deflect the catheter body, thereby reducing the likelihood of kinking. Therefore, the increased stiffness of the catheter body (characterized by a second portion made of a second material that is more rigid than the first material used to make the first portion of the catheter body) allows for the use of relatively longer catheter bodies while maintaining a similar or identical diameter to a catheter body with only the first portion and no second portion.

[0072] In some examples, by incorporating the second portion together with the first portion to form the tube body of the catheter, the length of the catheter body can be extended compared to a standard catheter body, and the range can be from about 8 cm to about 12 cm. Alternatively, the catheter body of this disclosure having the first portion and the second portion can also be used for shorter length catheter bodies or standard length catheter bodies, such as catheter bodies with a length from about 1.4 cm to 6.4 cm.

[0073] By utilizing a second part made of a second material that is more rigid than the first material of the first part, it is possible for the first part to be made of a softer, more flexible, and less rigid material, thereby reducing the possibility of damage to the inner surface of the vein wall due to contact.

[0074] In some examples, the first part can form the lower portion of the catheter body, while the second part can form the upper portion of the catheter body along the elevation direction. This arrangement can be useful for certain catheterizations, such as those used for superficial venous punctures.

[0075] The catheter body of the present invention (having a first portion made of a first material having a first hardness and a second portion made of a second material having a second hardness) can be used to limit or prevent kinking, can be used to make the catheter body relatively longer (compared to a standard catheter body made of a single material formed from the beginning), and / or for insertion into a patient's vein, but does not facilitate X-ray or image capture of the catheter body. The second material used to form the second portion can be a single strip of the second material, or can include two or more spaced-apart strips. Each strip can include a surface and cross-sectional area. This area can have a regular shape or an irregular shape.

[0076] The second portion, made of a second material that is more rigid than the first material of the first portion, may be referred to as the ridge or catheter ridge. As discussed above, the ridge (i.e., the second portion made of a second material with relatively greater rigidity) can help prevent or resist kinking of the catheter body, which, if it occurs, obstructs fluid flow through the catheter lumen. For example, after successful venipuncture, a kinked catheter body can obstruct or delay the flow of intravenous fluid to the patient. Therefore, it is preferable to use a kink-resistant catheter body. The catheter body of this disclosure (having a first portion of a first material and a second portion of a second material that is more rigid than the first material) is kink-resistant.

[0077] In the example, the second material of the ridge or second portion has a constant cross-sectional profile and extends longitudinally along the upper portion of the catheter body on the same side as the tabs of the catheter hub. That is, the exemplary embodiment has a ridge formed as a narrow strip having a substantially constant cross-sectional profile extending between the proximal end and the distal end of the catheter body.

[0078] In some examples, the ridge forms a narrow strip along the length of the duct body that does not have a constant cross-sectional profile.

[0079] In other embodiments, the ridge has a variable cross-sectional profile along the length of the catheter body. For example, the distal portion of the catheter body may have a relatively narrow cross-sectional profile, and the width of this cross-sectional profile may increase as the length extends in the proximal direction. Furthermore, instead of having tapered sidewalls for the ridge, these sidewalls may vary between straight, tapered, undulating, outwardly tapering, etc.

[0080] The first part joins together at the side of the catheter ridge to jointly form a seamless and smooth outer surface of the catheter body. This allows the catheter body to avoid snagging or cutting tissue when inserted into a vein and when fed into the desired location within the vein. The first part and the catheter ridge may also join together to form a seamless catheter lumen or inner surface. For example, the ridge may be co-extruded with the first part to form a seamless inner and outer surface of the catheter body.

[0081] In this embodiment, the ridge is oriented upwards, similar to the top or upper portion of the catheter body. In other words, the ridge may form the upper portion of the catheter body or catheter tubing, and the first portion may form the remaining portion or at least the lower portion of the catheter body along the elevation angle.

[0082] The cross-sectional profile of the ridge of the catheter body can occupy approximately 25 degrees to approximately 180 degrees of the arc of the catheter body, and the first portion can occupy the remainder of the catheter body. The ridge can occupy more or less of the catheter body, depending on the outer diameter of the catheter body and the desired overall stiffness of the catheter body. That is, the width of the cross-sectional profile and the shape of the ridge can determine the stiffness of the catheter body and therefore the desired length.

[0083] To increase the rigidity of the catheter body, the material of the ridge can be selected to be, for example, more rigid than the typical material used for the catheter body, such as more rigid than the rest of the material used to form the catheter body. The relatively more rigid material selected for the ridge can be used to form the entire catheter body, but more preferably only a few parts of the catheter body, while the rest can be formed using typical or conventional catheter body materials.

[0084] In the example, the catheter body has at least two different materials used to form the length of the catheter body, such as 50% or more of the length of the catheter body. In the example, the material of the ridge should be harder than the fluorinated ethylene propylene copolymer (FEP) material typically used for standard single-material catheter bodies. Another exemplary material that can be used to form the first part is polyurethane (PUR). In some examples, the second part used to form the ridge may be made of FEP, while the first part used to form the remainder of the catheter body may be made of PUR.

[0085] In a specific example, barium sulfate (BaSO4) can be used to form the ridge of the tube body. Therefore, as a specific example, a catheter body having a lumen can be formed using FEP or PUR material and BaSO4 material, wherein the BaSO4 material is used to form the ridge or second portion extending longitudinally along the tube body, and the FEP or PUR material forms the balancing portion of the tube body, which can be referred to as the first portion.

[0086] The first part can be made of a softer, common conduit material, which may include polyurethane (PUR) or femtosecond epoxide (FEP). In an example, BaSO4 material is mixed with an effective amount of polyether block amide (PEBA) or other compatible polymeric material to promote bonding with the first material, such as to promote bonding with FEP or PUR material. Any suitable biocompatible material can be used for the second part, provided that the material used to form the ridge has greater stiffness than the material used to form the first part.

[0087] The conduit body can be manufactured using a co-extrusion process. The second material used to form the ridge can be embedded in the inner and outer surfaces of the tube body, or can be co-extruded to form at least a portion of the outer surface, the inner surface, or both the inner and outer surfaces of the tube body.

[0088] In other examples, depending on various aspects of the catheter body, the tube body may have a plurality of ridges or a plurality of spaced-apart second portions, said ridges or second portions being formed of the material constituting the first portion to form the tube body of the catheter body.

[0089] Multiple ridges may be embedded in or not embedded in the inner and outer surfaces of the tube body, or there may be ridges embedded in the inner and outer surfaces of the tube body and ridges not embedded in the inner and outer surfaces of the tube body.

[0090] When one or more strips are incorporated into the ridge, the increased stiffness of the catheter body allows for the use of a longer catheter body. The catheter body can be made more rigid, at least along the segment or space occupied by the ridge, to reduce the likelihood of bending or kinking. Because the lower portion of the catheter body, having a first part and a second part, can be made of a softer material (a softer material is used to form the first part 152, and a relatively more rigid or harder material is used to form the ridge of the second part), the possibility of injury caused by contact between the lower portion of the catheter body and the inner wall tissue of the vein can be minimized.

[0091] To allow the catheter body to be used together with the catheter hub (where a ridge is formed along the upper portion of the body and a first portion formed from a more flexible or less rigid material along the lower portion of the body), the catheter body can be advanced into the vein after successful venipuncture, with the needle removed from the catheter body. During the advancement of the catheter body, the distal tip of the body encounters the inner wall of the vein. The reaction force of the inner wall counteracts the driving force of the catheter body, which is applied to the catheter body by the vein wall. The reaction force applied to the catheter body causes the catheter body to deflect, and the deflection angle increases.

[0092] This reaction force can cause the lower portion of the catheter body to bend upwards, resulting in the lower portion being under tension, and the upper portion of the catheter body (such as the second portion or the ridge) experiencing at least some compression. However, due to various aspects of the invention, the catheter body is more rigid when one or more ridges are incorporated together with the catheter body, so the upward deflection is limited by the rigidity of the ridges, thereby allowing the distal tip of the catheter body to advance further into the vein without bending upwards too far or too much (such as substantially or completely upwards) and contacting the opposite side (if it is the vein wall and kinking may occur).

[0093] For a typical catheter body, if it deflects too much upon encountering the inner wall of a vein, the catheter body will form tight bends or kinks, resulting in reduced or blocked fluid flow through the catheter lumen. Increasing the stiffness or Young's modulus of the catheter body (e.g., by incorporating ridges as disclosed herein) will require greater force to bend the catheter body, thus reducing the likelihood of kinks forming within the catheter body. The stiffness of the catheter body can be adjusted by changing the width or shape of the ridge's cross-sectional profile, reducing the number of ridges used with the catheter body, or by both.

[0094] In further examples, the relative stiffness between the second and first parts can be selected based on the choice of materials. Materials can be selected such that the material of the second part has a stiffness ratio from about 1.05 to 1.8 of the material stiffness of the first part. In still further examples, the stiffness ratio is chosen to be greater than about 1.8 of the material stiffness of the second part to the material stiffness of the first part. For example, the second material stiffness can have a Young's modulus (E) value of 3.7 MPa, and the first material stiffness can have a Young's modulus (E) value of 2.46 MPa, with a ratio of 1.5.

[0095] In one embodiment, the width of the cross-sectional profile of the ridge may be substantially constant longitudinally, extending from very close to the distal tip of the catheter body toward the proximal end of the catheter body. The ridge may or may not extend to the very proximal end of the catheter body. In another embodiment, the ridge may have a width or cross-sectional profile that increases or varies from a point at the distal end of the catheter body or tube (e.g., a point proximal to the tapered portion just at the distal end) or from the distal opening toward the proximal end of the catheter body or tube. In embodiments with increasing cross-sectional width, the stiffness of the tube body increases from the distal end of the tube body to the proximal end of the tube body. In still other examples, the distal point of the ridge may originate proximal to the tapered portion and extend up to several millimeters proximal to the tapered portion.

[0096] Besides the location of the ridge, its shape can also contribute to the stiffness of the conduit body. In one example, the ridge has an arched knot. The arched structure of the ridge and the cylindrical shape of the conduit body as a whole allow the conduit body to extend in a straight configuration along its longitudinal direction. The stiffness of the ridge and the conduit body can be increased by increasing the width of the cross-sectional profile of the arched ridge, which is wider along the outer surface of the ridge than along the inner surface. As the width of the cross-sectional profile of the ridge increases, the height of the arched ridge also increases, thereby dramatically increasing the moment of inertia of the ridge.

[0097] For comparison, when taking half a section of the conduit body and placing it on a flat surface, the height of the half section is greater than that of the quarter section. Therefore, by increasing the width of the cross-sectional profile of the ridge, the height can also be increased. The increase in moment of inertia also increases the stiffness of the ridge. In short, the stiffness of the conduit body can be adjusted by the shape of the ridge. For example, when the ridge has a first width of cross-sectional profile, the conduit body can have a first stiffness, and the conduit body can have a second stiffness by changing the shape of the cross-sectional profile to a second width, which is greater than the first width. In yet another example, stiffness can be increased by changing the angles of the two sidewalls of the arched ridge. For example, looking at… Figure 4The sidewalls of the ridge, which taper outward as they extend from the outer surface to the inner surface, make the inner arcuate surface wider than the outer arcuate surface.

[0098] The catheter body may include one or more ridges embedded within the wall thickness of the first portion. One, two, three, or more than three ridges are conceived. When more than one embedded ridge is incorporated (e.g., two or more ridges), these ridges may be equidistant or unequally spaced from each other. The ridges may be spaced away from the catheter lumen and the outer surface of the catheter body. The embedded ridges may be enclosed or sealed between the inner and outer surfaces of the catheter body.

[0099] The catheter body can have two types of ridges, such as one or more embedded ridges and one or more non-embedded ridges.

[0100] The ridge can be elliptical, circular, rectangular, or any other regular or irregular shape. The ridge can extend longitudinally and between the proximal and distal ends of the catheter body, including the nearest and farthest lateral ends. The embedded ridge can be made of the same material as the material used to form the unembedded ridge, or a softer material. The unembedded ridge has a surface exposed along the outer surface of the catheter body, along the inner surface of the catheter body, or both.

[0101] The material of the first part may be softer than the materials of: ridges embedded in the tube body, which are spaced apart from each other and have surfaces that are entirely within the inner and outer surfaces of the tube body; and ridges not embedded in the tube body, which have at least one surface exposed along the outer surface of the tube body, along the inner surface of the tube body, or both.

[0102] In the example, the unembedded ridge is made of BaSO4, and the first part is made of polyurethane. Alternatively, the first part is made of silicone. In yet another example, the first part is made of polyethylene. In still another example, the first part is made of a compound, such as Teflon / PTFE.

[0103] The ridge embedded within the tube body can be made of BaSO4. If BaSO4 is used, the material for the ridge can be blended with an effective amount of PEBA to promote bonding with the material of the first part. The properties of BaSO4 are sufficient to increase the stiffness of the catheter body and can also provide X-ray visibility. Aspects of this disclosure relate to using the disclosed catheter body to limit or prevent kinking compared to tube bodies made of a single material or a homogeneous blend composite, and to enable the manufacture of tube bodies of extended lengths.

[0104] In some examples, the relatively more rigid material used to form or manufacture the ridge is PEEK or PROPELL.TM In other examples, the second material used to manufacture the second part or ridge is basic bismuth carbonate (Bi2O2CO3) or bismuth oxychloride (BiOCl).

[0105] When the multiple strips of the second portion are incorporated together with the first portion to form the tube body of the catheter, the multiple strips of the second portion may be made of the same material or different materials. For example, in a catheter body embodiment having two embedded ridges and one non-embedded ridge, BaSO4 may be used to manufacture the non-embedded ridge, and Bi2O2CO3 may be used to manufacture the embedded ridge.

[0106] Ridges can increase the overall stiffness of the catheter body. Ridges can be embedded, non-embedded, or both. In some examples, the catheter body can have multiple ridge types, such as two or more embedded ridges and two or more non-embedded ridges. When incorporated, the one or more ridges should be positioned such that the area of ​​greater stiffness of the catheter body is along the upper portion of the catheter body. Ridges can also be positioned away from the distal tip and tapered portion of the catheter body to ensure that the distal tip of the catheter body remains the softer first portion. The catheter body can be manufactured using a co-extrusion process.

[0107] In the example, the three embedded ridges can be made of BaSO4 material and can be used for X-ray visibility and optical transparency. The non-embedded ridges can be relatively larger than the embedded ridges (e.g., having a larger perimeter or width) to increase the stiffness of the tube body along the upper portion. This arrangement has all the advantages of a similar conduit body (with a relatively stiffer upper portion) described elsewhere in this document.

[0108] The conduit body may include two non-embedded ridges spaced apart from each other by a first portion. A non-embedded ridge, or a strip of material with stiffness properties different from the material used to form the conduit body, is understood to be an object having an exposed internal surface, an exposed external surface, or both an exposed internal surface and an exposed external surface.

[0109] Two non-embedded ridges can be positioned away from the upper portion of the catheter body, such as along a horizontal midline that runs through the catheter body. In such embodiments, a softer first material is incorporated into both the upper and lower portions of the catheter body. Thus, the lower portion of the catheter body, which can contact the inner surface of the vein wall during catheter body advancement, will be the softer first portion made of the first material to minimize potential damage or injury to the vein wall.

[0110] In an embodiment where two non-embedded ridges are positioned away from the upper portion of the catheter body, the inner concave surfaces of the two ridges and the inner concave surface of the first portion, as well as the outer convex surfaces of the two ridges and the first portion, can collectively form the exterior of the catheter body. In one embodiment, the ridge of the second portion can be made of BaSO4 material, and the first portion can be made of polyurethane material. Optionally, an effective amount of PEBA can be incorporated together with the BaSO4 material to promote bonding.

[0111] The advantages of a catheter body having at least one ridge made of a material with increased stiffness (different from the rest of the tube body and positioned away from the lower portion of the catheter body) include greater resistance to bending and kinking, while maintaining a flexible lower portion that can contact the inner surface of the vein wall during catheter body advancement after venous puncture. The stiffness and therefore rigidity of the ridge can be configured according to the needs and application of the catheter device or equipment, or can be used for standard length catheters beyond the needle length, not just for extended length catheter bodies.

[0112] Greater benefits can be obtained when the teachings of this invention are used in conjunction with a relatively longer catheter body. Furthermore, the increased stiffness of the catheter body ensures patency (e.g., an unobstructed lumen), thereby preventing infection or phlebitis and reducing pain. Another benefit of the increased stiffness is that the catheter body of this invention can be advanced deep into the vein without a guidewire, although a guidewire can be used. The catheter body of this invention is an anti-kink catheter having a first portion and a second portion, the first and second portions being made of two different materials having two different stiffness properties, wherein the softer, more flexible material of the two is specifically positioned to minimize or prevent damage to the vein wall. For example, the softer, more flexible material can be positioned along the lower or bottom portion of the catheter body in an elevation direction.

[0113] The catheter body 150 according to various aspects of the invention may include a first segment or portion made of a first material and a second segment or portion made of a second material. The catheter body may have an outer surface and an inner surface defining a lumen. In this embodiment, the second portion may be a strip embedded in the first portion, such as embedded in the wall thickness of the first portion between the inner and outer surfaces. The second portion (which may be referred to as a ridge) may have a surface completely enclosed within the first portion. The first portion may be made of PUR or PEBA material, and the second portion may be made of FEP material. In other examples, the first portion may be made of FEP, PUR, or PEBA, and the second portion may be made of BaSO4. The second portion may be positioned along the upper portion of the catheter body in an elevation direction.

[0114] According to another aspect of the invention, the catheter body may include a first segment or portion made of a first material and a second segment or portion made of a second material. The catheter body has an outer surface and an inner surface defining a lumen. In this embodiment, the second portion may include three spaced strips embedded in the first portion, such as embedded in the wall thickness of the first portion between the inner and outer surfaces. The three strips of the second portion (which may be referred to as ridges) may each have a surface completely enclosed within the first portion. The first portion may be made of PUR or PEBA, and the second portion (such as the three ridges) may be made of FEP. In other examples, the first portion may be made of FEP, PUR, or PEBA, and the second portion (such as the three ridges) may be made of BaSO4. The second portion (i.e., the three ridges) may be positioned along the upper portion of the catheter body on a centerline passing through the center of the catheter body.

[0115] Methods of manufacturing and using needle catheter devices (where the catheter body has at least two different parts made of at least two different materials) are within the scope of this invention. Attached Figure Description

[0116] These and other features and advantages of this apparatus, system, and method will become more apparent from its description, claims, and drawings, in which:

[0117] Figure 1 This is a cross-sectional view of an over-the-needle catheter device or apparatus according to an embodiment of the present disclosure.

[0118] Figure 2 This is a front schematic diagram of a conduit assembly or hub according to an embodiment of the present disclosure.

[0119] Figure 3 According to embodiments of this disclosure Figure 1 A schematic diagram of a cross-section of the conduit hub taken at line 3-3, the conduit hub including the conduit body.

[0120] Figure 4 yes Figure 3 A schematic diagram of a cross-section of the catheter body taken at point 4-4. The catheter body includes a first body and a second body.

[0121] Figure 5 yes Figure 1 A perspective view of a portion of the conduit body.

[0122] Figure 6 yes Figure 5 A schematic diagram of the outline of this part of the conduit body.

[0123] Figure 7 and Figure 8 This is a schematic diagram of the catheter in a vein after venipuncture.

[0124] Figure 9 This is a schematic cross-sectional view of the conduit body according to another embodiment of the present disclosure.

[0125] Figure 10 This is a schematic cross-sectional view of the conduit body according to another embodiment of the present disclosure.

[0126] Figure 11 This is a schematic end view of the cross-section of a conduit body according to another embodiment of the present disclosure.

[0127] Figure 12 This is a schematic end view of the cross-section of another conduit body according to another embodiment of the present disclosure. Detailed Implementation

[0128] The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of embodiments of intravenous catheter devices, apparatuses, and components having a catheter body with a reinforced region provided according to various aspects of the present apparatus, system, and method, and is not intended to represent the only form in which the present apparatus, system, and method can be constructed or utilized. This description sets forth the features and steps for constructing and using embodiments of the present apparatus, system, and method in conjunction with the illustrated embodiments. However, it will be understood that the same or equivalent functions and structures may be implemented by different embodiments that are also intended to be included within the spirit and scope of this disclosure. As indicated elsewhere herein, similar reference numerals are intended to indicate similar or analogous elements or features.

[0129] Figure 1 A cross-sectional view of an intravenous catheter device or apparatus 100 is depicted, shown in a ready position, with a needle tip 102 extending distally for venous puncture. Throughout this disclosure, the catheter device or apparatus 100 may also be interchangeably referred to as an extraneous catheter device, catheter assembly, or needle device. The catheter device, assembly, or apparatus 100 includes: a needle 101 having a needle tip 102 connected to a needle hub 103; a catheter hub 110 including a hub body 111 defining a lumen 112; and a catheter body 150 extending distally to the catheter hub 110. The catheter body may be attached to the catheter hub using a conventional collar or metal bushing. The needle hub 103 is shown directly coupled to or in contact with the proximal end of the catheter hub 110. In other examples, the needle hub 103 may be indirectly coupled to the proximal end of the catheter hub 110 via an intermediate hub (not shown). For example, a third hub, as shown in Figures 13 and 14 of U.S. Patent No. 8,591,468 ('468 Patent), may be disposed between the guide hub and the needle hub, with the needle hub spaced apart from the guide hub. For all purposes, the contents of the '468 Patent are expressly incorporated herein by reference.

[0130] In the preparatory position, before the catheter body 150 is inserted into the patient's vein, a needle 101 with a needle tip 102 protrudes through the lumen or orifice 156 of the catheter body 150. The needle tip 102 is shown as having a bevel, wherein the bevel faces away from the patient's skin or upwards. The upward-facing bevel of the needle tip 102 is oriented in the same manner as the upper portion of the catheter hub body and away from the lower portion facing the patient's skin.

[0131] The needle 101 protrudes through the lumen 156 of the catheter body 150 and forms a seal with the distal opening 149 at the distal end of the catheter body 150 to prevent blood from flowing through the annular space between the catheter body 150 and the outside of the needle 101 after successful venipuncture. The distal opening 149 at the distal end of the catheter body 150 tapers inward, and this opening forms a tight fit around the needle, such that when the needle 101 and the catheter body 150 are inserted together into the patient, the catheter body 150 will not snag on any tissue, such as skin or vein wall, during the insertion of the needle 101 into the vein. As the needle 101 pierces the patient's vein wall and enters the vein, blood can flow through the needle 101 into the needle hub 103. Blood can flow into the lumen 106 of the needle hub 103 and / or into the blood collection device or vent plug 107 located proximal to the needle hub 103. This is called primary reflux, which is used to indicate proper venipuncture entry.

[0132] The needle protector 104 can be positioned inside the cavity 112 of the catheter hub 110. In an example, the needle protector 104 can be a clip type that is mounted on the needle 101 and can slide on the needle 101 to cover the needle tip 102. For example, the needle protector 104 can have a... Figure 1 The surface positioned on one side of the needle in the ready-to-use position, and wherein the surface is movable distally to the needle tip in the protected position to cover the needle tip in case of accidental puncture. Optionally, the needle protector 104 may be substantially outside the catheter hub, such as being positioned in a third housing located between the needle hub and the catheter hub, as previously described with reference to '468 patent. In another example, the needle protector may be of a retractable type, which retracts the needle 101 and the needle tip 102 into the protective housing, with or without a spring. In the case that the needle protector is of a clip type, a contour-changing portion 105 (such as a pleat or bulge) may be incorporated proximally to the needle tip 102 for engaging the enclosure defining the opening on the needle protector 104. In other examples, a tether may be used instead of a contour-changing portion to prevent the needle protector from displacing distally away from the needle. An exemplary catheter assembly is shown in U.S. Patent No. 8,333,735, the contents of which are expressly incorporated herein by reference.

[0133] In other examples, the valve and valve opener may be positioned within the catheter hub 110 to restrict blood flow from a proximal opening in the hub body after successful venipuncture and removal of the needle and needle hub from the catheter hub. The valve may have one or more slits defining one or more flaps. By inserting the tip of a male Luer element into the catheter hub to push the valve opener distally, the valve opener may be advanced distally into the valve to open it. Aspects of the valve and valve opener are discussed in U.S. Patent No. 8,333,735, which is previously incorporated herein by reference.

[0134] Figure 2 The diagram shows... Figure 1 A front view of the catheter hub 110, shown without the needle 101 and needle hub 103, as seen from the distal end or proximal end of the catheter body towards the hub. The catheter hub 110 includes a tab 114 positioned on the upper portion of the catheter hub 110. The tab 114 can function as a lever during insertion and / or removal of the needle and needle hub. The tab 114 is shown located at the “upper portion” of the catheter hub 110 in an elevation direction, which will be referenced below. Figure 3 Further detailed description. The registration groove 90 is located on the catheter hub and opposite the tab 114. The registration groove 90 is configured to receive a rib or protrusion on the needle hub to facilitate the alignment and orientation of the needle and needle hub with the catheter hub. The registration groove 90 may be located at the external threads of the catheter hub.

[0135] Figure 3 It is along Figure 2The image shows a cross-sectional side view of the conduit hub 110 taken from line 3-3. The conduit hub 110 has a hub body 111 with walls and an inner cavity 112 defined by the inner wall surface of the hub body. The conduit hub 110 further includes a conduit body 150 in fluid communication with the inner cavity 112 of the hub body 111. As shown, the conduit body 150 is attached to a distal segment 116 of the hub body 111 using conventional means (e.g., using a metal bushing 120). The metal bushing 120 can act as a wedge to secure the proximal end of the conduit body 150 to the hub body 111. In other embodiments, the conduit body 150 communicates with the inner cavity 112 of the hub body 111 and a fluid port extending from one side of the hub body 111. If the fluid port is incorporated, a flexible valve, typically in a cylindrical configuration, can be located inside the conduit hub to control fluid flow through the fluid port. The fluid port may extend at an angle from or perpendicular to the axis of the hub body 111. The hub body 111 has a proximal inlet or proximal opening 113 at a proximal section 115. The proximal section at the opening 113 may have or may incorporate a female Luer taper for receiving a male Luer tip, such as a male infusion line, syringe, or male Luer adapter. The proximal section 115 may also include external threads 92 for secure engagement with threads on a male Luer locking fitting or syringe tip (also referred to as a Luer lock).

[0136] The catheter hub 110 may also include a tab 114 positioned on the hub body 111 (between the proximal segment 115 and the distal segment 116 of the hub body 111) to assist in clamping and / or guiding the needle device when it is inserted into the patient's vein. Hereinafter, the upper portion of the catheter hub or hub body 111 is where the tab 114 is located. If the tab 114 is omitted, the upper portion is understood as the portion facing upwards or away from the patient's skin. Further, the upper portion or upward direction is understood to mean, along the elevation direction, the portion of the catheter hub, catheter device, or hub body at a pair of wings 125 (… Figure 1 The portion or direction above or above the lower hub portion, which is configured to contact the patient's skin.

[0137] like Figure 1As shown, in the ready-to-use position of the needle device, the bevel of the needle tip 102 faces upward (e.g., towards the upper portion of the catheter hub if the catheter hub 110 extends directly onto the bevel) and is away from the patient's skin. The tab 114 can be used as a reference point to orient the needle device relative to the patient's skin and puncture site. With the bevel of the needle oriented in the same upward direction as the upper portion of the catheter hub (where the tab 114 is located), the position of the tab can serve as an indicator of the bevel's position when the needle device is inserted into the patient's vein, and when the catheter hub 110 is mounted and secured to the patient after a successful venous puncture. As shown, the tab 114 has a rectangular shape with smooth edges. Undulated surfaces may be incorporated into one or more of these edges. However, the tab 114 can exhibit any shape and thickness. Grooves or small protrusions may be formed on the surface of the tab to help hold or retain the tab 114. See below for reference. Figure 4-6 Furthermore, the position of the tab 114 can also be used to indicate the reinforcement or enhancement area of ​​the catheter body 150.

[0138] A pair of wings 125 (see) Figure 1 The hub body 111 may extend laterally to provide an additional surface area for supporting the catheter hub 110 against the patient. In some embodiments, the catheter hub 110 may also be equipped with a diaphragm or valve (not shown) located inside the lumen 112 of the hub body 111 or adjacent to the proximal inlet 113 of the hub body 111 to restrict or constrain fluid flow across the catheter hub 110.

[0139] Now for reference Figure 4-6 And continue to refer to Figure 1 and Figure 2 The catheter body 150 includes a catheter body or tube body 151 having an outer or outer surface 158 and an inner or inner surface 137 defining an inner lumen or catheter inner lumen 156 in fluid communication with a catheter hub. The catheter body 150 of this embodiment, as well as other catheter bodies of this application, can be used with catheter hubs described elsewhere herein.

[0140] The catheter body 151 has a wall thickness between its outer surface 158 and its inner surface. The diameter of the catheter lumen 156 is large enough to surround the needle 101 and to deliver fluid to and / or from the patient at the desired flow rate after successful venous puncture. As shown, the inner diameter proximal to the distal or distal opening 149, or the catheter lumen 156, is slightly larger than the diameter of the needle 101. The catheter body 151 has a tapered portion 157 at its distal or distal tip, and the proximal end can be connected to the hub body 111 indirectly or directly by, for example, a metal bushing 120 or some other attachment means (such as adhesive).

[0141] The catheter body or tube body 151 has a wall thickness between its outer surface or outer boundary 158 and the inner surface defining the catheter lumen 156. The wall thickness may be constant along the length of the catheter body 151 proximal to the tapering portion 157, and decreases at the tapering portion 157 toward the distal opening 149 at the distal end of the catheter body 151. In other words, the diameter of the outer surface 158 of the catheter body 151 is substantially the same along the length of the catheter body 151 proximal to the tapering portion 157, and decreases at the tapering portion 157 toward the distal opening 149 at the distal end of the catheter body 151.

[0142] A distal lumen opening, or distal opening 154, is defined at the distal end of the catheter body 151. In an embodiment, the diameter of the distal lumen opening 154 is smaller than the nominal diameter of the catheter lumen 156, such that the distal opening 154 of the distal end 149 has a form fit around the needle. As shown, the distal lumen opening 154 is slightly smaller than the diameter of the needle to form a seal with the needle. When the needle is removed after successful venipuncture or when the needle is moved proximally such that at least a portion of the bevel is within the lumen 156 of the catheter body 151, the seal between the distal lumen opening 154 and the needle is terminated to allow blood to flow into the catheter lumen 156, thereby indicating that the catheter body 150 has successfully penetrated the vein and provided access to the patient's vascular system. This is referred to as secondary reflux.

[0143] The catheter body 151 includes a first portion 152 formed of a first material and a second portion formed of a second material 155, the first and second portions being joined together to form a tubular structure. The tubular structure formed of the catheter body having at least the first portion 152 and the second portion 155 can have a uniform outer surface and a uniform inner surface. Both the first and second materials can be flexible. However, the second material can be harder or more rigid than the first material. For example, the stiffness property of the second material can be higher than that of the first material. Therefore, the stiffness of the catheter body 151 along the upper portion or upward direction according to various aspects of the invention can be more rigid or have a higher stiffness property than the rest of the catheter body 151.

[0144] As shown in the figure, both the first portion 152, made of a first material, and the second portion 155, made of a second material, each form an arcuate structure with a concave inner surface and a convex outer surface. However, the sides of the first and second portions can have any shape, such that the overall shape of the first and second portions can also have any shape other than having arcuate inner and outer surfaces. The lengths of the first portion 152 and the second portion 155 extend parallel to the axis of the catheter body 150. The sides of the first portion 152 connect to the sides of the second portion 155 to cooperatively form the catheter body 150. That is, both the first portion 152, made of the first material, and the second portion 155, made of a second material (different from the first material), extend longitudinally side by side and parallel to the axis of the catheter body 150. The concave inner surface of the first portion 152 and the concave inner surface of the second portion 155 are joined together to form the catheter lumen 156, and the convex outer surface of the first portion 152 and the convex outer surface of the second portion 155 together form the outer surface or outer boundary 158 of the catheter body 151. In other examples, there may be multiple first portions and multiple second portions, which are joined together to form the catheter body of the present invention.

[0145] In some embodiments, the concave inner surface of the second portion 155, made solely of the second material, and the convex surface of the second portion 155 respectively form the outer surfaces of the catheter lumen 156 and the catheter body 151, while the first portion 152, made solely of the first material, is embedded within the inner and outer surfaces of the second portion 155 (e.g., within the wall thickness). In other embodiments, the concave inner surface of the first portion 152, made solely of the first material, and the convex surface of the first portion 152 respectively form the outer surfaces of the catheter lumen 156 and the catheter body 151, while the second portion 155, made solely of the second material, is embedded within the inner and outer surfaces of the first portion 152 (e.g., within the wall thickness).

[0146] The stiffness (k) of the second portion 155, made of the second material, is greater than the stiffness of the first portion 152, made of the first material, and the second portion is positioned along the upper portion or upward direction of the tube body 151. Therefore, in the case where the catheter body 150 has both the first portion 152 and the second portion 155, the second portion 155 forms a region of the catheter body that is more rigid than other parts of the catheter body not made of the second material. Since the reinforcing region of the catheter body 151 is formed by the second portion 155, the overall stiffness of the catheter body 151 can be increased compared to a catheter body made entirely of the first material. Therefore, the elastic modulus or Young's modulus (E) of the catheter body 151, proportional to its stiffness, is also greater than that of a catheter body without a reinforcing region.

[0147] The shape of the second portion 155 can also affect the overall stiffness of the conduit body 151. For example, the overall stiffness of the conduit body can be increased by increasing the moment of inertia of the second portion 155. In this example, the increase in moment of inertia can be achieved by increasing the cross-sectional area of ​​the ridge or by changing the shape of the ridge. When the stiffness of the second portion 155 increases, the overall elastic modulus of the conduit body 150 can increase. Again, the stiffness of the second portion can be increased by changing its shape and / or width.

[0148] The increased stiffness of the catheter body 151 may require greater force to deflect the catheter body 150, thereby reducing the likelihood of kinking. Therefore, the increased stiffness of the catheter body 151 (characterized by a second portion 155 made of a second material that is more rigid than the first material used to form the first portion 152 of the catheter body 150) allows for the use of a relatively longer catheter body 150 while maintaining a diameter similar to or the same as a catheter body having only the first portion and no second portion. In the example, the second portion may be positioned along the upper portion of the catheter body 151 or in an upward direction.

[0149] In some examples, by incorporating the second portion 155 together with the first portion 152 to form the tube body of the catheter body, the length of the catheter body can be extended compared to a standard catheter body, and the range can be from about 8 cm to about 12 cm. Alternatively, the catheter body of this disclosure having the first portion 152 and the second portion 155 can also be used for shorter length catheter bodies or standard length catheter bodies, such as catheter bodies with a length from about 1.4 cm to 6.4 cm.

[0150] By using a second part 155 made of a second material that is more rigid than the first material of the first part 152 to form the catheter body having at least two arcuate segments connected along two sets of longitudinal edges, it is possible to make the first part 152 from a softer, more flexible, and less rigid material, thereby reducing the possibility of damage to the internal surface of the vein wall due to contact, as further referenced below. Figure 7 and Figure 8The discussion focuses on the following. In some examples, the first portion 152 may form the lower portion of the catheter body 151, while the second portion 155 may form the upper portion of the catheter body 151 in the elevation direction. The catheter body of the present invention (having a first portion made of a first material having a first hardness and a second portion made of a second material having a second hardness) can be used to limit or prevent kinking, can be used to make the catheter body relatively longer (compared to a standard catheter body made of a single material formed from beginning to end), and / or for entry into a patient's vein, but does not facilitate X-ray or image capture of the catheter body. The second material used to form the second portion may be a single strip of the second material, or may include two or more spaced strips. Each strip may include a surface and cross-sectional area. This area may have a regular or irregular shape. Kinking resistance may be due to a more rigid material having a higher elastic modulus or Young's modulus (E) and / or a higher moment of inertia compared to when the catheter body is made of only a single, softer or less rigid material.

[0151] The second portion 155, made of a second material that is more rigid than the first material of the first portion 152, may be referred to as the ridge or catheter ridge 155. As discussed above, the ridge 155 (i.e., the second portion 155 made of a second material with relatively greater rigidity) can help prevent or resist kinking of the catheter body 150, which, if it occurs, would obstruct fluid flow through the catheter lumen 156. For example, after a successful venipuncture, a kinked catheter body would obstruct intravenous infusion to the patient. Therefore, it is preferable to use a kink-resistant catheter body. The catheter body of this disclosure (having a first portion of a first material and a second portion of a second material that is more rigid than the first material) is kink-resistant.

[0152] In the example, such as Figure 3-5 As shown, the second material of the ridge 155 or the second portion has a constant cross-sectional profile, and extends along the upper portion of the conduit body 151 in accordance with the description above. Figure 3The ridge 155 extends longitudinally on the same side as the tab 114 of the catheter hub 110 or above the horizontal midplane of the catheter body. Specifically, an exemplary embodiment of the catheter body has a ridge 155 formed as a narrow strip having a substantially constant cross-sectional profile extending between the proximal and distal ends of the catheter body 150. In some examples, the ridge 155 forms part of the arcuate outer portion and part of the arcuate inner portion of the catheter body 150. In some embodiments, the ridge 155 forms a narrow strip that does not have a constant cross-sectional profile along the length of the catheter body 151. In other embodiments, the ridge 155 has a variable cross-sectional profile along the length of the catheter body 151. For example, the distal portion of the catheter body may have a relatively narrow cross-sectional profile, and the width of this cross-sectional profile may increase as the length extends in the proximal direction. Furthermore, instead of having tapered sidewalls for the ridge 155, these sidewalls may vary between straight, tapered, undulating, outwardly tapering, etc.

[0153] The first portion 152 joins with the lateral portion of the second portion's catheter ridge 155 to jointly form a seamless and smooth outer surface 158 of the catheter body 151 and an inner surface of the catheter body. This allows the catheter body 150 to avoid snagging or cutting tissue when inserted into a patient to access a vein and when fed into the desired location within the vein. The first portion 152 and the catheter ridge 155 may also join together to form a seamless catheter lumen 156 along the inner surface of the catheter body. For example, the ridge 155 may be co-extruded with the first portion 152 to form seamless inner and outer surfaces.

[0154] As discussed above, in the embodiments, the ridge 155 is oriented upwards or along an upper portion similar to the top side or upper portion of the catheter body 151. In other words, the ridge 155 may constitute the upper portion of the catheter body or catheter tube 151, and the first portion 152 may constitute the remaining portion or at least the lower portion of the catheter body 151. Figure 4 As shown, the cross-sectional profile of the ridge or second portion 155 of the catheter body 151 may occupy approximately 25 degrees to approximately 180 degrees of the arc of the catheter body 151, and the first portion 152 may occupy the remainder of the catheter body 151. The ridge 155 may occupy more or less of the catheter body 151, depending on the outer diameter of the catheter body 151 and the desired overall stiffness of the catheter body 151. That is, the width of the cross-sectional profile and the shape of the ridge 155 can determine the stiffness of the catheter body 151 and therefore the desired length.

[0155] To increase the stiffness of the catheter body 151, the material of the ridge 155 can be selected to be, for example, more rigid than the typical material used for a catheter body. The relatively more rigid material selected for the ridge can be used to form the entire catheter body or only a few sections of the catheter body, while the remaining sections can be formed using typical or conventional catheter body materials. In the example, the body of the catheter body has at least two different materials used to form the length of the body, such as 50% or more of the length of the body. In the example, the material of the ridge 155 should be more rigid than the fluorinated ethylene propylene copolymer (FEP) material typically used for standard single-material catheter bodies. Another exemplary material that can be used to form the first section 152 is polyurethane (PUR). In some examples, the second section may be made of FEP, while the first section is made of PUR.

[0156] In a specific example, barium sulfate (BaSO4) can be used to form the ridge. Therefore, as a specific example, a catheter body having a lumen can be formed using FEP or PUR material and BaSO4 material, wherein the BaSO4 material is used to form the ridge or second portion 155 extending longitudinally along the catheter body, and the FEP or PUR material forms the balance portion of the catheter body, which can be referred to as the first portion 152. The first portion 152 can be made of a softer, common catheter material, which may include polyurethane (PUR) or FEP. In the example, the BaSO4 material is mixed with an effective amount of polyether block amide (PEBA) or other compatible polymer material to promote bonding with the first material, such as to promote bonding with the FEP or PUR material. Any suitable biocompatible material can be used for the second portion 155, provided that the material used to form the ridge of the second portion has greater stiffness properties than the material used to form the first portion 152. The catheter body 150 can be manufactured by a co-extrusion manufacturing process. The second material used to form the ridge 155 can be embedded in the inner and outer surfaces of the tube body 151 (e.g., Figure 11 and 12 (as shown), or can be co-extruded to form at least a portion of the outer surface, the inner surface, or both the inner and outer surfaces of the tube body (such as, Figure 9 and Figure 10 (As shown in the diagram). In other examples, depending on various aspects of the catheter body, the tube body 151 may have a plurality of ridges or a plurality of spaced-apart second portions formed within or enclosed by a first portion to form the tube body. The plurality of ridges may or may not be embedded in the inner and outer surfaces of the tube body, or there may be ridges embedded in the inner and outer surfaces of the tube body and ridges not embedded in the inner and outer surfaces of the tube body, as shown in the diagram. Figure 9 As shown in the image.

[0157] When one or more strips of the ridge 155 are incorporated, the increased stiffness of the catheter body 151 allows for the use of a longer catheter body 150. The catheter body 151 can be made more rigid, at least along the section or space occupied by the ridge 155, to reduce the likelihood of bending or kinking. Because the lower portion of the catheter body 151, having the first portion 151 and the second portion 155, can be made of a softer material (a softer material is used to form the first portion 152, and a relatively more rigid or harder material is used to form the ridge 155 of the second portion), the possibility of injury caused by contact between the lower portion of the catheter body 151 and the inner wall tissue of the vein can be minimized.

[0158] Now for reference Figure 7 and Figure 8 In particular, referring to the ridge 155 formed along the upper portion of the catheter body 151 and the first portion 152 formed along the lower portion of the catheter body 150 by a more flexible or less rigid material, the catheter body 150 can be advanced into the vein after successful venipuncture and removal of the needle from the catheter body 150. During the advancement of the catheter body 150, the distal tip 149 of the catheter body 151 may encounter the inner wall or venous wall 135 of the vein 130. The reaction force of the inner wall 135 of the vein counteracts the driving force of the catheter body 150, and this reaction force is applied to the catheter body 150 by the venous wall 135. The reaction force applied to the catheter body 150 causes the catheter body 150 to deflect and the deflection angle increases, such as Figure 8 As shown in the diagram. More specifically, the reaction force will cause the lower portion of the catheter body 151 to bend upward, resulting in the lower portion being under tension, and the upper portion of the catheter body 151 (such as the second portion or ridge 151) experiencing at least some compression. However, due to various aspects of the invention, the catheter body 150 is more rigid when one or more ridges 155 are incorporated together with the catheter body, so the upward deflection is limited by the rigidity of the ridges, thereby allowing the distal tip of the catheter body 150 to advance further into the vein without bending upward too far or too much (such as substantially or completely upward) and contacting the opposite side (if it is the vein wall 135 and kinking may occur).

[0159] For a typical conduit body, if the deflection is too large, the conduit body will form tight bends or kinks, resulting in reduced or blocked fluid flow through the conduit lumen. Increasing the stiffness or Young's modulus of the conduit body 150 (e.g., by incorporating the ridges 155 of this disclosure) will require greater force to bend the conduit body 150, thus reducing the likelihood of kinks forming in the conduit body 150. The stiffness of the conduit body 150 can be adjusted by changing the width or shape of the cross-sectional profile of the ridges 155 or by reducing the number of ridges used with the conduit body. In other examples, the relative stiffness between the second and first portions can be selected based on the choice of materials. Materials can be selected such that the material of the second portion has a stiffness ratio of about 1.05 to 1.8 of the first material stiffness compared to the material of the first portion. In other examples, the stiffness ratio is selected to be greater than about 1.8 of the second material stiffness to the first material stiffness.

[0160] In one embodiment, the width of the cross-sectional profile of the ridge 155 may be substantially constant longitudinally, extending from very close to the distal tip of the catheter body 151 and toward the proximal end of the catheter body 151. The ridge 155 may or may not extend to the very proximal end of the catheter body 151. In another embodiment, the ridge 155 may have a width or cross-sectional profile that increases or varies from a point at the distal end of the catheter body or tube 151 (e.g., a point proximal to the tapered portion at the distal end) or from the distal opening and extends toward the proximal end of the catheter body or tube 151. In embodiments with increasing cross-sectional width, the stiffness of the tube body increases from the distal end of the tube body to the proximal end of the tube body 151. In still other examples, the distal point of the ridge 155 may originate proximal to the tapered portion 157 and extend up to several millimeters proximal to the tapered portion.

[0161] Besides the location of the ridge 155, the shape of the ridge 155 can also contribute to the stiffness of the conduit body 150. In one example, the ridge 155 has an arched structure, such as... Figure 4-5 As shown in the diagram, the arched structure of the ridge 155 and the cylindrical shape of the conduit body 150 as a whole allow the conduit body 150 to extend in a straight configuration along its longitudinal direction. The stiffness of the ridge and the conduit body can be increased by increasing the width of the cross-sectional profile of the arched ridge 155, which is wider along its outer surface than along its inner surface. As the width of the cross-sectional profile of the ridge 155 increases, the height of the arched ridge 155 also increases, thereby dramatically increasing the moment of inertia of the ridge 155.

[0162] In comparison, with the removal of the catheter body 1 / 2 segment and place it on a flat surface compared to when taking the catheter body1 / 4 section and when placed on a flat surface 1 The / 2 section is higher. Therefore, the height can also be increased by increasing the width of the cross-sectional profile of the ridge. The increase in moment of inertia also increases the stiffness of the ridge 155. In short, the stiffness of the conduit body 150 can be adjusted by the shape of the ridge 155. For example, when the ridge has a cross-sectional profile of a first width, the conduit body can have a first stiffness, and the conduit body can have a second stiffness by changing the shape of the cross-sectional profile to a second width, which is greater than the first width. In yet another example, the stiffness can be increased by changing the angles of the two sidewalls of the arched ridge 155. For example, looking at... Figure 4 The sidewalls of the ridge 155 may taper outward as they extend from the outer surface to the inner surface, such that the inner arcuate surface is wider than the outer arcuate surface.

[0163] Figure 9 Another embodiment of a catheter body 150 having a catheter body 151 (shown along an end cross section) is shown. Figure 9 The catheter body 150 and Figure 2-6 The catheter body 150 shown in the diagram is similar, except that... Figure 9 The catheter body 150 further includes one or more ridges 153 embedded within the wall thickness of the first portion 152. Three ridges 153 are shown, with one, two, or more than three ridges contemplated for use with the catheter body. When more than one embedded ridge 153 is incorporated, these ridges 153 may be equidistant or unequally spaced from each other. The ridges 153 may be spaced away from the catheter lumen 156 and the outer surface 158 of the catheter body 151. As shown, the embedded ridges 153 are enclosed or sealed between the inner and outer surfaces of the catheter body 151. Thus, aspects of the invention may include a catheter body having a catheter body, wherein the ridges or second segments are provided with an outer surface, an inner surface, or both an outer and inner surface extending or flowing from the first segment of the catheter body, and wherein the second ridge is enclosed or sealed between the inner and outer surfaces of the first segment of the catheter body 151. The additional ridge may be enclosed or sealed by the first section of the tube body, the ridge being made of a material less rigid than the material used to form the ridge.

[0164] The ridge 153 can be elliptical, circular, rectangular, or any other regular or irregular shape. The ridge 153 can extend longitudinally and between the proximal and distal ends of the catheter body 151, including the nearest and farthest lateral ends to the proximal and distal ends. The material of the embedded ridge 153 can be the same as or softer than the material used to form the unembedded ridge 155. The unembedded ridge 155 has surfaces exposed along the outer surface of the catheter body, along the inner surface of the catheter body, or both.

[0165] The material of the first portion 152 is softer than that of the following: ridges 153 embedded within the tube body 151, spaced apart from each other and having surfaces entirely within the inner and outer surfaces of the tube body 151; and ridges 155 not embedded within the tube body 151, having at least one surface exposed along the outer surface of the tube body, along the inner surface of the tube body, or both. In an example, the unembedded ridges 155 are made of BaSO4, and the first portion 152 is made of polyurethane. Alternatively, the first portion 152 is made of silicone. In yet another example, the first portion is made of polyethylene. In still another example, the first portion 152 is made of a compound, such as Teflon / PTFE.

[0166] The ridge 153 embedded within the tube body 151 can be made of BaSO4. If BaSO4 is used, the material for the ridge can be blended with an effective amount of PEBA to promote bonding with the material of the first portion 152. The properties of BaSO4 are sufficient to increase the stiffness of the catheter body and will also provide X-ray visibility. Aspects of this disclosure relate to using the disclosed catheter body to limit or prevent kinking and enable the manufacture of tube bodies of extended lengths compared to those made from a single material or a homogeneous blend.

[0167] In some examples, the relatively more rigid material used to form or manufacture the ridge 155 is PEEK or PROPELL. TM In other examples, the second material used to manufacture the second part or ridge is basic bismuth carbonate (Bi2O2CO3) or bismuth oxychloride (BiOCl).

[0168] When the multiple strips of the second portion 155 are incorporated together with the first portion 152 to form the tube body 151 of the catheter body, the multiple strips of the second portion may be made of the same material or different materials. For example, in a catheter body embodiment having two embedded ridges 153 and one non-embedded ridge 155, BaSO4 may be used to manufacture the non-embedded ridge, and Bi2O2CO3 may be used to manufacture the embedded ridge.

[0169] Ridges can increase the overall stiffness of the catheter body 150. Ridges can be embedded 153 or non-embedded 155, or both. In some examples, the catheter body 151 can have multiple ridge types, such as two or more embedded ridges 153 and two or more non-embedded ridges 155. When incorporated, the one or more ridges should be positioned such that the area of ​​greater stiffness of the catheter body is along the upper portion of the catheter body. Ridges 153 can also be positioned away from the distal tip and tapered portion 154 of the catheter body 151 to ensure that the distal tip of the catheter body 151 remains the softer first portion 152. The catheter body can be manufactured using a co-extrusion process.

[0170] In the example, Figure 9 The three embedded ridges 153 can be made of BaSO4 material and can be used for X-ray visibility and optical transparency. The non-embedded ridges 155 can be relatively larger than the embedded ridges 153 (e.g., having a larger circumference or width) to increase the stiffness of the tube body along the upper portion of the tube body. This arrangement has all the advantages of a similar conduit body (with a relatively more rigid upper portion) described elsewhere in this document.

[0171] Figure 10 Another embodiment of a catheter body 150 having a catheter body 151 (shown along an end cross section) is shown. Figure 10 The catheter body 151 in the middle and Figure 2-6 Similar to the catheter body 151 depicted in the text, except... Figure 10 The conduit body 151 includes two non-embedded ridges 155 spaced apart from each other by a first portion 152. A non-embedded ridge, or a strip of material with stiffness properties different from the material used to form the conduit body, is understood to be an object having an exposed internal surface, an exposed external surface, or both. In other words, Figure 10 The embodiments have more Figure 2-6 The embodiments include more spines.

[0172] As shown in the figure, the two ridges 155 are not located at the upper portion of the catheter body 151, but rather along a horizontal midline passing through the catheter body. A softer first material 152 is incorporated at both the upper and lower portions of the catheter body 151. Therefore, the lower portion of the catheter body 151, which can contact the inner surface of the vein wall 135 during the advancement of the catheter body 150, will be the softer first portion 152 made of the first material, to minimize potential damage or injury to the vein wall 135. Figure 10In one embodiment, the inner concave surfaces of the two ridges 155 and the inner concave surface of the first portion 152 together form the catheter lumen 156, and the outer convex surfaces of the two ridges 155 and the outer convex surface of the first portion 152 together form the outer surface of the catheter body. In one embodiment, the ridges 155 may be made of BaSO4 material, and the first portion 152 may be made of polyurethane material. Optionally, an effective amount of PEBA may be incorporated together with the BaSO4 material to promote bonding.

[0173] The advantages of a catheter body 150 with a ridge made of a material with increased stiffness (compared to the material used to form the rest of the tube body and positioned away from the lower portion of the catheter body 150) include greater resistance to bending and kinking, while maintaining a flexible lower portion that can contact the inner surface of the vein wall during the advancement of the catheter body 150 after venous puncture. The stiffness and therefore rigidity of the ridge 155 can be configured according to the needs and application of the catheter device, assembly, or equipment 100, or can be used for standard length catheters beyond the needle length, not just for extended length catheter bodies.

[0174] Greater benefits can be obtained when the teachings of the invention are used in conjunction with a relatively longer catheter body 150. Furthermore, the increased stiffness of the catheter body ensures patency (e.g., an unobstructed lumen), thereby preventing infection or phlebitis and reducing pain. Another benefit of the increased stiffness is that the catheter body of the present invention can be advanced deep into the vein without a guidewire, although a guidewire can be used. The catheter body 150 of the present invention is an anti-kink tube having at least two first and second portions made of two different materials having two different stiffness properties, wherein the softer, more flexible material of the two is specifically positioned to minimize or prevent damage to the vein wall 135. For example, the softer, more flexible material may be positioned along the lower or bottom portion of the catheter body.

[0175] Now for reference Figure 11The diagram illustrates a catheter body 150 having a tube body 151 provided according to another aspect of the invention. This catheter body 150 is similar to other catheter bodies described elsewhere herein and includes a first portion or segment 152 made of a first material and a second portion or segment 153 made of a second material. The tube body 151 has an outer surface 158 defining an inner lumen 156 and an inner surface 137. In this embodiment, the second portion or segment 153 is a strip embedded in the first portion 152. The second portion 153 (which may be referred to as a ridge) has a surface completely enclosed within the first portion 152. The first portion 152 may be made of PUR or PEBA material, and the second portion 153 may be made of FEP material. In other examples, the first portion 152 may be made of FEP, PUR, or PEBA material, and the second portion 153 may be made of BaSO4 material. As shown, the second portion 153 is positioned along the upper portion of the tube body 151 in an elevation direction.

[0176] Now for reference Figure 12 This illustration shows a catheter body 150 having a tube body 151 provided according to a further aspect of the invention. This catheter body 150 is similar to other catheter bodies described elsewhere herein and includes a first segment or portion 152 made of a first material and a second segment or portion 153 made of a second material. The tube body 151 has an outer surface 158 defining an inner lumen 156 and an inner surface 137. In this embodiment, the second portion 153 includes three spaced-apart strips embedded in the first portion 152. Each of the three strips of the second portion 153 (which may be referred to as ridges) has a surface completely enclosed within the first portion 152. The first portion 152 may be made of PUR or PEBA, and the second portion 153 (such as the three ridges) may be made of FEP. In further examples, the first portion 152 may be made of FEP, PUR, or PEBA, and the second portion 153 (such as the three ridges) may be made of BaSO4. As shown in the figure, the second part 153 is positioned above the centerline 163 that passes through the center of the tube body 151, along the upper part of the tube body 151.

[0177] Methods of manufacturing and using needle catheter devices (where the catheter body has at least two different parts made of at least two different materials) are within the scope of this invention.

[0178] Although limited embodiments of intravenous catheter assemblies and their components (including a catheter body having a first portion and a second portion, which may be one or more ridges) have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, various intravenous catheter assemblies and catheter bodies with ridges may incorporate other forms of ridge features, etc. Furthermore, it should be understood and contemplated that features specifically discussed for one intravenous catheter assembly embodiment may be incorporated with another intravenous catheter assembly embodiment, provided that functional compatibility is maintained. For example, a catheter body with embedded ridges may be used in another embodiment having a non-embedded configuration. Therefore, it will be understood that intravenous catheter assemblies and their components constructed according to the principles of the disclosed devices, systems, and methods may also be embodied, in addition to those specifically described herein. This disclosure is also defined in the appended claims.

Claims

1. A catheter assembly (100) comprising: The catheter hub (110) has a catheter body (150) attached thereto. A needle (101) having a needle tip (102) attached to a needle hub (103) and the needle (101) protruding through the catheter body (150), wherein the needle tip (102) protrudes distally to a distal opening (149) of the catheter body (150); The catheter body (150) includes a catheter body (151) having a wall, the catheter body having an outer surface (158), an inner surface (137), a wall thickness between the outer surface (158) and the inner surface (137), and an inner lumen (156) defined by the inner surface (137), the catheter body (151) comprising: A first portion (152) having a wall thickness is formed of a first material having a first stiffness property. The first portion (152) has an inner surface and an outer surface. The inner surface forms at least a portion of the inner surface (137) of the inner cavity (156) and the inner surface (151) of the catheter body (151). The outer surface forms at least a portion of the outer surface (158) of the catheter body (151). A second portion (153) formed of a second material having a second stiffness property, the length of the second portion (153) being at least 50% of the length of the conduit body; Wherein, the second stiffness property of the second material is greater than the first stiffness property of the first material; The second portion (153) is embedded within the wall thickness of the catheter body (150), such that the second portion (153) is enclosed or sealed between the outer surface (158) and the inner surface (137) of the catheter body. The second portion is positioned above the centerline passing through the center of the catheter body along the upper portion of the catheter body, wherein the upward-facing bevel of the needle tip is oriented in the same manner as the upper portion.

2. The catheter assembly of claim 1, wherein, The second part (153) has a cross-sectional profile of a certain width, which is constant along the length of the conduit body (150).

3. The catheter assembly according to claim 1, wherein, The length of the catheter body (151) is between 1.4 cm and 6.4 cm or between 8 cm and 12 cm.

4. The catheter assembly according to claim 1, wherein, The distal end of the catheter body (150) is tapered.

5. The catheter assembly according to claim 1, wherein, The first material comprises polyurethane (PUR) and has a stiffness property lower than that of the second material.

6. The catheter assembly according to claim 1, wherein, The first material comprises fluorinated ethylene propylene (FEP) and has a stiffness property lower than that of the second material.

7. The catheter assembly according to claim 1, wherein, The first material comprises polyether block amide (PEBA) and has a stiffness property lower than that of the second stiffness property.

8. The catheter assembly according to claim 1, wherein, The second material is barium sulfate (BaSO4).

9. The catheter assembly according to claim 1, wherein, The second material is fluorinated ethylene propylene (FEP).

10. The catheter assembly of claim 1, wherein, The first portion (152) and the second portion (153) extend from the distal opening (149) of the catheter body (151) or very close to the distal opening (149) of the catheter body (151) toward the proximal end of the catheter body (151).

11. The catheter assembly of claim 1, wherein, The catheter body (151) has three strips of spaced-apart ridges (153), each strip having a stiffness property greater than the first stiffness property.

12. The catheter assembly of claim 1, wherein, The second portion (153) is a first ridge, and the catheter assembly further includes a second ridge spaced apart from the first ridge.

13. The catheter assembly of claim 1, further comprising a needle guard (104) having a surface configured to move distally toward the needle tip (102) to cover the needle tip (102).

14. A method of forming a catheter assembly (100), the method comprising: A conduit hub (110) is formed, the conduit hub having a conduit body (150) attached thereto. A needle hub (103) is formed having a needle (101) having a needle tip (102), and the needle (101) protrudes through the catheter body (150), wherein the needle tip (102) protrudes distally to the distal opening (149) of the catheter body (150); The catheter body (150) includes a catheter body (151) having a wall, the catheter body having an outer surface (158), an inner surface (137), a wall thickness between the outer surface (158) and the inner surface (137), and an inner lumen (156) defined by the inner surface (137). The catheter body (151) includes: A first portion (152) having a wall thickness is formed of a first material having a first stiffness property. The first portion (152) has an inner surface and an outer surface. The inner surface forms at least a portion of the inner surface (137) of the inner cavity (156) and the inner surface (151) of the catheter body (151). The outer surface forms at least a portion of the outer surface (158) of the catheter body (151). A second portion (153) formed of a second material having a second stiffness property, the length of the second portion (153) being at least 50% of the length of the conduit body; Wherein, the second stiffness property of the second material is greater than the first stiffness property of the first material; The second portion (153) is embedded within the wall thickness of the catheter body (150), such that the second portion (153) is enclosed or sealed between the outer surface (158) and the inner surface (137) of the catheter body. The second portion is positioned above the centerline passing through the center of the catheter body along the upper portion of the catheter body, wherein the upward-facing bevel of the needle tip is oriented in the same manner as the upper portion.

15. A catheter assembly (100) comprising: The catheter hub (110) has a catheter body (150) attached thereto. A needle (101) having a needle tip (102) attached to a needle hub (103) and the needle (101) protruding through the catheter body (150), wherein the needle tip (102) protrudes distally to a distal opening (149) of the catheter body (150); The catheter body (150) includes a catheter body (151) having a wall, the catheter body having an outer surface (158), an inner surface (137), a wall thickness between the outer surface (158) and the inner surface (137), and an inner lumen (156) defined by the inner surface (137). The catheter body (151) includes a first portion (152) and a second portion (153), wherein the first portion (152) has a first stiffness property, and the second portion (153) has a second stiffness property and a length of at least 50% of the length of the catheter body, wherein the second stiffness property is greater than the first stiffness property. The second portion (153) is embedded within the wall thickness of the catheter body (150), such that the second portion (153) is enclosed or sealed between the outer surface (158) and the inner surface (137) of the catheter body. The second portion is positioned above the centerline passing through the center of the catheter body along the upper portion of the catheter body, wherein the upward-facing bevel of the needle tip is oriented in the same manner as the upper portion.

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