Reinforced catheter tip, catheter, and method thereof

Abstract

Catheters, including reinforced catheter tips, rapid insertion central catheters (RICCs), and methods thereof reduce the number of steps and medical devices involved in introducing a catheter into a patient. In one example of a catheter, the RICC includes a catheter tube, a catheter hub coupled to a proximal portion of the catheter tube, and a number of extension legs extending from the catheter hub. The catheter tube includes a first section at a distal portion of the catheter tube and a second section proximal to the first section. The first section of the catheter tube terminates distally at a catheter tip reinforced with a reinforcing band therein. The number of extension legs extending from the catheter hub are equal in number to the number of lumens extending through the RICC. In another example, a method includes a method of making an RCC as described above.

Description

[Technical field]

[0001] The present invention relates to a reinforced catheter tip, catheter, and method thereof. [Background technology]

[0002] Central venous catheters ("CVCs") are typically introduced into a patient and advanced through the patient's vascular system using the Seldinger technique. The Seldinger technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming, the handling of many of the medical devices is cumbersome, and both of the foregoing can lead to trauma to the patient. In addition, due to the large number of medical devices that need to be replaced during the Seldinger technique, there is a relatively high potential for contact contamination. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system.

[0003] Disclosed herein are catheters, including reinforced catheter tips, rapidly insertable central catheters ("RICCs"), and methods thereof, that reduce the number of steps and medical devices involved in introducing a catheter into a patient. Summary of the Invention

[0004] In some embodiments, a RICC is disclosed herein that includes a catheter tube, a catheter hub coupled to a proximal portion of the catheter tube, and a plurality of extension legs extending from the catheter hub. The catheter tube includes a first section at a distal portion of the catheter tube and a second section proximal to the first section. The first section of the catheter tube terminates distally at a catheter tip reinforced with a reinforcing band therein. The plurality of extension legs extending from the catheter hub are equal in number to a plurality of lumens extending through the RICC.

[0005] In some embodiments, the stiffening band has sufficient stiffness over its length to support aspiration through the RICC without collapsing the catheter tip. In some embodiments, the reinforcement band has sufficient stiffness over its length to prevent buckling of the catheter tip when the RICC is inserted into the needle path, optionally over an access guidewire, into the vessel lumen.

[0006] In some embodiments, the stiffening band is formed from a thermoplastic polymer or metal onto which the first section of the catheter tubing is molded or extruded. In some embodiments, the stiffening band is formed from a thermoplastic polymer selected from thermoplastic polyurethanes, carbonate-based thermoplastic polyurethanes, polyamides, and polyamide-block-polyether copolymers.

[0007] In some embodiments, the stiffening band is formed from a metal selected from stainless steel, titanium, and nitinol. In some embodiments, the RICC is a three-lumen catheter including a trifurcated catheter hub as a catheter hub and three extension legs for multiple extension legs, each of the three extension legs including a luer connector coupled to a proximal portion of the extension leg.

[0008] In some embodiments, the RICC includes a primary lumen, a secondary lumen, and a tertiary lumen. The primary lumen extends from an opening at the proximal end of the first Luer connector to an opening at the catheter tip. The secondary lumen extends from an opening at the proximal end of the second Luer connector to a secondary lumen opening at the distal portion of the second section of the catheter tube. The tertiary lumen extends from an opening at the proximal end of the third Luer connector to a tertiary lumen opening at the distal portion of the second section of the catheter tube proximal to the secondary lumen opening.

[0009] In some embodiments, each of the secondary and tertiary lumens terminates at the distal end of the second section of the catheter tube. In some embodiments, the proximal end of the first section of the catheter tubing is attached to the distal end of the second section of the catheter tubing.

[0010] In some embodiments, a first section of the catheter tube is formed from a first polymeric material having a first durometer and a second section of the catheter tube is formed from a second polymeric material having a second durometer that is less than the first durometer.

[0011] In some embodiments, each of the first and second polymeric materials is a polyurethane. In some embodiments, each of the secondary and tertiary lumens terminates within an intermediate portion of the first section of the catheter tube.

[0012] In some embodiments, an outer layer of the catheter tube is extruded onto an inner layer of the catheter tube, the inner layer of the catheter tube including a reinforcement band thereon. In some embodiments, the first section of the catheter tube tapers from the second section of the catheter tube toward the catheter tip, whereas the second section of the catheter tube has a constant outer diameter.

[0013] Also disclosed herein in some embodiments is a catheter tube including a first section at a distal portion of the catheter tube and a second section proximal to the first section. The first section of the catheter tube has a single catheter tube lumen therethrough. In addition, the first section of the catheter tube terminates distally at a catheter tip reinforced with a reinforcement band therein. The second section of the catheter tube has two or more catheter tube lumens therethrough, including the same catheter tube lumen as the catheter tube lumen through the first section of the catheter tube.

[0014] In some embodiments, the stiffening band has sufficient stiffness over its length to support aspiration through the catheter tube without collapsing the catheter tip.

[0015] In some embodiments, the reinforcement band has sufficient stiffness over its length to prevent buckling of the catheter tip when the catheter tube is inserted into the needle path, optionally over an access guidewire, into the vessel lumen.

[0016] In some embodiments, the stiffening band is formed from a thermoplastic polymer or metal onto which the first section of the catheter tubing is molded or extruded. In some embodiments, the stiffening band is formed from a thermoplastic polymer selected from thermoplastic polyurethanes, carbonate-based thermoplastic polyurethanes, polyamides, and polyamide-block-polyether copolymers.

[0017] In some embodiments, the stiffening band is formed from a metal selected from stainless steel, titanium, and nitinol. In some embodiments, the catheter tube is a three-lumen catheter tube including a primary catheter tube lumen, a secondary catheter tube lumen, and a tertiary catheter tube lumen. The primary catheter tube lumen corresponds to a catheter tube lumen through both the first and second sections of the catheter tube. The primary catheter tube lumen extends from an opening at the proximal end of the second section of the catheter tube to an opening at the catheter tip. The secondary catheter tube lumen extends from an opening at the proximal end of the second section of the catheter tube to a secondary lumen opening at a distal portion of the second section of the catheter tube. The tertiary catheter tube lumen extends from an opening at the proximal end of the second section of the catheter tube to a tertiary lumen opening at a distal portion of the second section of the catheter tube proximal to the secondary lumen opening.

[0018] In some embodiments, each of the secondary and tertiary catheter tube lumens terminates at a distal end of the second section of the catheter tube.

[0019] In some embodiments, the proximal end of the first section of the catheter tubing is attached to the distal end of the second section of the catheter tubing. In some embodiments, a first section of the catheter tube is formed from a first polymeric material having a first durometer and a second section of the catheter tube is formed from a second polymeric material having a second durometer that is less than the first durometer.

[0020] In some embodiments, each of the first and second polymeric materials is a polyurethane. In some embodiments, each of the secondary and tertiary catheter tube lumens terminates within an intermediate portion of the first section of the catheter tube.

[0021] In some embodiments, an outer layer of the catheter tube is extruded onto an inner layer of the catheter tube, the inner layer of the catheter tube including a reinforcement band thereon. In some embodiments, the first section of the catheter tube tapers from the second section of the catheter tube toward the catheter tip, the second section of the catheter tube having a constant outer diameter.

[0022] In some embodiments, a method for making a catheter tube is also disclosed herein, the method including an inner layer forming step, a banding step, a drawing step, an outer layer forming step, and a catheter tube cutting step. The inner layer forming step includes forming an inner layer of the catheter tube by extruding a single-lumen tube of a first polymeric material using an extruder. The banding step includes banding the single-lumen tube at regular intervals using a plurality of reinforcing bands to form a banded single-lumen tube. The reinforcing bands are regularly interspersed along the banded single-lumen tube. The drawing step includes drawing the banded single-lumen tube through a die of the same or a different extruder using a drawing machine. The outer layer forming step includes periodically extruding a melt of the first polymeric material or the second polymeric material through a die around the banded single-lumen tube to form an output tube having a section of the single-lumen tube and including regularly interspersed sections of layered tube. The catheter tube cutting step includes periodically cutting the output tube just before each section of layered tubing having sections of single lumen tubing and regularly interspersed therebetween, thereby forming the catheter tube.

[0023] In some embodiments, the method further comprises an adhesive layer applying step, which comprises applying an adhesive layer onto the single lumen tube prior to extruding a melt of the first or second polymeric material through a die around the banded single lumen tube in the outer layer forming step.

[0024] In some embodiments, the method further comprises a lumen forming step, which comprises forming one or more additional lumens in the lumen of the single lumen tube by injecting air into the melt of the first or second polymeric material while extruding the melt of the first or second polymeric material through a die around the banded single lumen tube in the outer layer forming step.

[0025] In some embodiments, the method further includes an opening cutting step, which includes cutting one or more openings in the catheter tube to correspondingly establish one or more openings for one or more additional lumens.

[0026] In some embodiments, the method further includes a tapering step, which includes periodically increasing a pulling speed of the output tube with a pulling machine and returning the pulling speed of the output tube to a constant pulling speed to form a tapered first section and a constant diameter second section of each of the catheter tubes.

[0027] In some embodiments, the first section of each of the catheter tubes terminates in a catheter tip that is reinforced with one of the reinforcement bands.

[0028] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon review of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0029] [Figure 1] 1 illustrates a perspective view of a RICC, according to some embodiments. [Diagram 2] 1 illustrates an exploded view of a RICC, according to some embodiments. [Diagram 3] 1 shows a detailed view of a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 4A] 4 shows a cross-sectional view of a distal portion of the catheter tube of FIG. 3 according to some embodiments. [Figure 4B] 4 shows another cross-sectional view of the distal portion of the catheter tube of FIG. 3 according to some embodiments. [Figure 4C] 4 shows yet another cross-sectional view of the distal portion of the catheter tube of FIG. 3 according to some embodiments. [Figure 4D] 4 shows yet another cross-sectional view of the distal portion of the catheter tube of FIG. 3 according to some embodiments. [Figure 5A] 4 shows a longitudinal cross-sectional view of the distal portion of the catheter tube of FIG. 3 along a sagittal plane, according to some embodiments. [Figure 5B] 4 shows a longitudinal cross-sectional view of the distal portion of the catheter tube of FIG. 3 along a coronal plane, according to some embodiments. [Figure 6] 13 shows a detailed view of a distal portion of another catheter tube of a RICC, according to some embodiments. [Figure 7A] 7 shows a cross-sectional view of a distal portion of the catheter tube of FIG. 6 according to some embodiments. [Figure 7B] 7 shows another cross-sectional view of the distal portion of the catheter tube of FIG. 6 according to some embodiments. [Figure 7C] 7 shows yet another cross-sectional view of the distal portion of the catheter tube of FIG. 6 according to some embodiments. [Figure 7D] 7 shows yet another cross-sectional view of the distal portion of the catheter tube of FIG. 6 according to some embodiments. [Figure 8]7 illustrates a method of forming a tube for the catheter tube of FIG. 6, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0031] With regard to the terms used herein, it should also be understood that each term is intended to describe certain embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps from one another within a group of features or steps, and do not impose any order or numerical limitations. For example, the "first," "second," and "third" features or steps do not necessarily have to appear in this order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Also, unless otherwise indicated, any of the features or steps may be sequential, and may further include one or more features or steps. Designations such as "left," "right," "upper," "lower," "front," and "rear" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such designations are used to indicate, for example, relative positions, orientations, or directions. Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural.

[0032] With respect to "proximal," for example, a "proximal portion" or "proximal section" of a catheter disclosed herein includes the portion or section of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. Although a proximal portion, section, or length of a catheter can include the proximal end of the catheter, a proximal portion, section, or length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, section, or length of a catheter is not a terminal portion or length of the catheter.

[0033] With respect to "distal," for example, a "distal portion" or "distal section" of a catheter includes a portion or section of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, section, or length of a catheter can include the distal end of the catheter, a distal portion, section, or length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, section, or length of a catheter is not a terminal portion or length of a catheter.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As mentioned above, the Seldinger technique is efficient in terms of introducing a CVC into a patient, but many steps are time-consuming, the handling of many medical devices is cumbersome, and both of the above may lead to trauma to the patient. In addition, due to the large number of medical devices that need to be replaced during the Seldinger technique, the possibility of contact contamination is relatively high. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing a catheter such as a CVC into a patient and advancing the catheter through the patient's vascular system.

[0035] Disclosed herein are catheters including reinforced catheter tips, RICCs, and methods thereof that reduce the number of steps and medical devices involved in introducing a catheter into a patient. In one example, the RICC can include a catheter tube, a catheter hub coupled to a proximal portion of the catheter tube, and a plurality of extension legs extending from the catheter hub. The catheter tube can include a first section at a distal portion of the catheter tube and a second section proximal to the first section. The first section of the catheter tube can terminate distally at a catheter tip reinforced with a reinforcing band therein. The plurality of extension legs extending from the catheter hub can be equal in number to the plurality of lumens extending through the RICC. In another example, a method can include a method of making the aforementioned RICC.

[0036] The foregoing and other features of the reinforced catheter tips, catheters (e.g., RICCs), and methods disclosed herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in detail certain embodiments of the foregoing, beginning with a RICC. However, it should be understood that CVCs such as RICCs are only one type of catheter that may include a reinforced catheter tip such as that disclosed herein. Indeed, other CVCs, peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like, may include reinforced catheter tips for their rapid-insertion versions.

[0037] RIC 1 and 2 show different views of a RICC 100, according to some embodiments.

[0038] As shown, the RICC 100 includes a catheter tube 102 or 202, a catheter hub 104, one or more extension legs 106, and one or more extension leg connectors 108.

[0039] 3, 4A-4D, 5A and 5B show various views of the catheter tube 102 of a RICC 100, according to some embodiments. However, it should be understood that a CVC such as the RICC 100 is only one type of catheter that may include the catheter tube 102 and its reinforced catheter tip 114. Indeed, other CVCs, PICCs, dialysis catheters, and the like, may include the catheter tube 102 and its reinforced catheter tip 114 for rapid insertion versions of such catheters.

[0040] As shown in the figure, the catheter tube 102 includes a first section 110 at a distal portion of the catheter tube 102 and a second section 112 proximal to the first section 110 .

[0041] The first section 110 of the catheter tube 102 terminates distally at a catheter tip 114 reinforced with a reinforcing material therein. Furthermore, the first section 110 of the catheter tube 102 tapers from a flat proximal end of the first section 110, the proximal end of which is fixedly coupled to the distal end of the second section 112 of the catheter tube 102, to the distal end of the first section 110 or its catheter tip 114. In effect, the first section 110 of the catheter tube 102 includes a taper from an outer diameter of the proximal end of the first section 110, which corresponds to an outer diameter of the second section 112 of the catheter tube 102, to an outer diameter of the distal end of the first section 110 or its catheter tip 114. The taper of the first section 110 of the catheter tube 102 is configured to immediately dilate the tissue around the needle path established by the introducer needle to the outer diameter of the second section 112 of the catheter tube 102.

[0042] The second section 112 of the catheter tube 102 includes a constant outer diameter along its length from the flattened distal end of the second section 112 to the proximal end of the second section 112. The constant diameter of the second section 112 of the catheter tube 102 is configured for smooth insertion into the aforementioned needle tract and target vasculature after expansion by the first section 110 of the catheter tube 102.

[0043] The first section 110 and the second section 112 of the catheter tube 102 are fixedly attached to each other at their ends. In fact, the flat surface proximal end of the first section 110 of the catheter tube 102 is attached to the flat surface distal end of the second section 112 of the catheter tube 102 by solvent bonding, adhesive bonding, or heat welding. The abluminal surface of the catheter tube 102 smoothly transitions from the abluminal surface of the first section 110 of the catheter tube 102 to the abluminal surface of the second section 112 of the catheter tube 102 so as to provide minimal to negligible edges that catch on the skin when the catheter tube 102 is inserted into the needle path. And, when solvent bonded, minimal to negligible edges can include solvent interdiffusion of the polymeric materials from which the first section 110 and second section 112 of the catheter tube 102 are formed, which smooths the transition from the first section 110 of the catheter tube 102 to the second section 112 of the catheter tube 102.

[0044] 6 and 7A-7D show various views of the catheter tube 202 of the RICC 100, according to several other embodiments. Again, it should be understood that a CVC such as the RICC 100 is just one type of catheter that may include the catheter tube 202 and its reinforced catheter tip 114. Indeed, other CVCs, PICCs, dialysis catheters, and the like, may include the catheter tube 202 and its reinforced catheter tip 114, for rapid insertion versions of such catheters.

[0045] As shown in the figure, the catheter tube 202 is similar to the catheter tube 102 in that it includes a first section 110 at a distal portion of the catheter tube 202 and a second section 112 proximal to the first section 110.

[0046] The first section 110 of the catheter tube 202 terminates distally in a catheter tip 114 that is reinforced with a reinforcing material therein. Additionally, the first section 110 of the catheter tube 202 tapers from the proximal end of the first section 110 toward the distal end of the first section 110 or its catheter tip 114. In effect, the first section 110 of the catheter tube 202 includes a taper from an outer diameter of the proximal end of the first section 110 that corresponds to an outer diameter of the second section 112 of the catheter tube 202 to an outer diameter of the distal end of the first section 110 or its catheter tip 114. Again, the taper of the first section 110 of the catheter tube 202 is configured to immediately dilate the tissue around the needle path established by the introducer needle to the outer diameter of the second section 112 of the catheter tube 202.

[0047] The second section 112 of the catheter tube 202 includes a constant outer diameter along its length from the distal end of the second section 112 to the proximal end of the second section 112. Again, the constant diameter of the second section 112 of the catheter tube 202 is configured for smooth insertion into the aforementioned needle tract and target vasculature after expansion by the first section 110 of the catheter tube 202.

[0048] Unlike the catheter tube 102, the first section 110 and the second section 112 of the catheter tube 202 are not fixedly bonded to each other at their ends, but are extruded together in accordance with the method of manufacturing the catheter tube 202 described below. In fact, the catheter tube 202 includes an outer layer 116 extruded onto an inner layer 118, optionally with an adhesive layer 120 therebetween, the inner layer 118 of the catheter tube 202 being formed from a single lumen tube as described in the method of manufacturing the catheter tube 202 below. Notably, by extruding the first section 110 and the second section 112 of the catheter tube 202 in a co-extrusion, the abluminal surface of the catheter tube 202 transitions smoothly from the abluminal surface of the first section 110 of the catheter tube 202 to the abluminal surface of the second section 112 of the catheter tube 202, such that the catheter tube 202 has minimal to negligible edges that catch on the skin when the catheter tube 202 is inserted into a needle path.

[0049] The first section 110 of the inner layer 118 of the catheter tube 102 or 202 may be formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer. The second section 112 of the outer layer 116 of the catheter tube 102 or 202 may be formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer less than the first durometer. For example, a first section 110 of the inner layer 118 of the catheter tube 102 or 202 can be formed from a first polyurethane having a first durometer, while a second section 112 of the outer layer 116 of the catheter tube 102 or 202 can be formed from a second, different polyurethane (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or with different additives, etc.) having a second durometer that is less than the first durometer. Indeed, polyurethanes are advantageous for the catheter tube 102 or 202 in that they are relatively stiff at room temperature but can become more flexible at body temperature in vivo, thereby reducing irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous in that they can be less thrombogenic than some other polymers. Notwithstanding the above, however, the first and second sections 110, 112 or the inner and outer layers 116, 118 of the catheter tube 102 or 202 may be formed from the same polymeric material selected from among the polymeric materials discussed above.

[0050] It should be understood that the first durometer of the first polymeric material and the second durometer of the second polymeric material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer of the second polymeric material may not be numerically less than the first durometer of the first polymeric material when the second durometer is less than the first durometer. In fact, the hardness of the second polymeric material may still be less than the hardness of the first polymeric material because each of the different scales ranging from 0 to 100 are designed to characterize different materials in a group of materials having similar hardness.

[0051] Returning to the catheter tip 114 of the first section 110 of the catheter tube 102 or 202, the catheter tip 114 may include a reinforcement band 122 as a reinforcement within the catheter tip 114. Such a reinforcement band has sufficient stiffness over its length to support aspiration through the catheter tube 102 or 202, or the RICC 100 including the catheter tube 102 or 202, without collapsing the catheter tip 114. Additionally or alternatively, the reinforcement band 122 has sufficient stiffness over its length to prevent buckling of the catheter tip 114 when the catheter tube 102 or 202, or the RICC 100 including the catheter tube 102 or 202, is inserted into a needle path, optionally over an access guidewire, into a vessel lumen of the target vasculature. The reinforcement band 122 may be formed from a metal or thermoplastic polymer inserted into a bore of the first section 110 of the catheter tube 102 corresponding to the reinforcement band 122. Alternatively, the first section 110 of the catheter tube 102 may be molded or extruded over the metallic or polymeric reinforcement band 122. Still alternatively, the outer layer 116 of the catheter tube 202 may be extruded over the metallic or polymeric reinforcement band 122, as described below in the method of manufacturing the catheter tube 202. When the reinforcement band 122 is formed from a metal, the metal may be selected from at least stainless steel, titanium, and nitinol. When the reinforcement band 122 is formed from a thermoplastic polymer, the thermoplastic polymer may be selected from at least thermoplastic polyurethane, carbonate-based thermoplastic polyurethane, polyamide, and polyamide-block-polyether copolymer. Advantageously, the thermoplastic polymer of the reinforcement band 122 may be selected to remain relatively stiff in vivo at body temperature, as opposed to those described above for the first and second sections 110 and 112 or the inner and outer layers 116 and 118 of the catheter tube 102 or 202.Additionally, the thermoplastic polymer of the stiffening band 122 can be formulated to include a radiopaque agent, such as bismuth trioxide or barium sulfate, to improve the radiopacity of the catheter tip 114 .

[0052] The catheter tube 102 or 202 includes one or more catheter tube lumens extending therethrough. Typically, however, in a single lumen or multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), there is only one catheter tube lumen extending from the proximal end of the catheter tube 102 or 202 to the distal end of the catheter tube 102 or 202. In fact, the first section 110 of the catheter tube 102 or 202 typically includes a single lumen therethrough, as shown in Figures 3 and 4A-4D for the catheter tube 102 and in Figures 6 and 7A-7D for the catheter tube 202. In particular, as shown in Figures 3 and 4A-4D, the secondary lumen 130 and the tertiary lumen 132 terminate at the distal end of the second section 112 of the catheter tube 102. Alternatively, as shown in Figures 6 and 7A-7D, the secondary lumen 130 and the tertiary lumen 132 terminate within an intermediate portion of the first section 110 of the catheter tube 202.

[0053] According to the above-described first section 110 or inner layer 118 of the catheter tube 102 or 202, second section 112 or outer layer 116 of the catheter tube 102 or 202, and catheter tip 114, the catheter tube 102 or 202 has sufficient column strength to prevent buckling of the catheter tube 102 or 202 when inserted into a needle path established by an introducer needle into a patient's vascular lumen, optionally in combination with an access guidewire disposed therein. The column strength of the catheter tube 102 or 202 is also sufficient to prevent buckling of the catheter tube 102 or 202 when advanced through a patient's vasculature without pre-dilating the tissue or blood vessels of the vasculature around the needle path with a separate dilator. Indeed, the column strength of the catheter tube 102 or 202 is noteworthy in that it allows the catheter tube 102 or 202, or a RICC 100 including the catheter tube 102 or 202, to be rapidly inserted into a needle path into a vascular lumen and the catheter tube 102 or 202 to be advanced through a patient's vascular system without the use of the Seldinger technique.

[0054] The catheter hub 104 includes a pair of suture wings 124 that include a number of suture wing through holes 126 for suturing the catheter hub 104 to a patient. Each wing of the pair of suture wings 124 can include one, two, three, or four suture wing through holes 126 for suturing the catheter hub 104 to a patient.

[0055] The catheter hub 104 also includes one or more catheter hub lumens that correspond in number to the one or more catheter tube lumens. The one or more catheter hub lumens extend entirely through the catheter hub 104 from the proximal end of the catheter hub 104 to the distal end of the catheter hub 104. When the catheter hub 104 is coupled to a proximal portion of a catheter tube 102 or 202, as shown in FIG. 1, the one or more catheter tube lumens continue through the one or more catheter hub lumens, respectively.

[0056] Each extension leg of the one or more extension legs 106 is coupled by its distal portion to the catheter hub 104 and thus extends from the catheter hub 104. Each of the one or more extension legs 106 includes one or more extension leg lumens, the number of which corresponds to the number of the catheter hub lumens. Each extension leg lumen of the one or more extension leg lumens extends entirely through the extension leg from the proximal end of the extension leg to the distal end of the extension leg. When the one or more extension legs 106 are coupled to the catheter hub 104, as shown in FIG. 1, the one or more catheter hub lumens continue through the one or more extension leg lumens, respectively.

[0057] Each of the one or more extension leg connectors 108 is on a proximal portion of one of the one or more extension legs 106. For example, each of the one or more extension leg connectors 108 may be a Luer connector on a proximal portion of one of the one or more extension legs 106. Through such an extension leg connector, a corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen.

[0058] The RICC 100 may be a single lumen RICC or a multi-lumen RICC, such as a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc. When the RICC 100 is configured as a three-lumen RICC as shown in Figures 1 and 2, the RICC 100 includes a set of three lumens. The set of three lumens includes a primary lumen 128, a secondary lumen 130, and a tertiary lumen 132 formed from the fluidly connected portions of the three catheter tube lumens of the catheter tube 102 or 202, the three catheter hub lumens of the trifurcated hub for the catheter hub 104, and the three extension leg lumens of the three extension legs 106. The primary lumen 128 has a primary lumen opening 134 at the distal end of the first section 110 of the catheter tube 102 or 202 or at its catheter tip 114, which corresponds to the distal end of the RICC 100. The secondary lumen 130 has a secondary lumen opening 136 on the side of the distal portion of the catheter tube 102 or 202. The tertiary lumen 132 has a tertiary lumen opening 138 on the side of the distal portion of the catheter tube 102 or 202 proximal to the secondary lumen opening 136.

[0059] method The methods include methods for making the catheter tube 102 or 202 of the above-mentioned RICC 100. For example, the method for making the catheter tube 202 includes one or more steps selected from an inner layer forming step, a banding step, an adhesive layer application step, a drawing step, an outer layer forming step, a tapering step, a lumen forming step, a catheter tube cutting step, and an opening cutting step.

[0060] The inner layer forming step involves forming the inner layer 118 of the catheter tube 202 by extruding a single lumen tube of a first polymeric material using an extruder 140 .

[0061] The banding step includes using a plurality of reinforcing bands to band the single lumen tube at regular intervals to form a banded single lumen tube 142. The reinforcing bands are regularly interspersed along the banded single lumen tube 142.

[0062] The adhesive layer application step involves applying an adhesive layer 120 onto the single lumen tube or banded single lumen tube 142 before a melt 144 of the first or second polymeric material is extruded through a die 146 of an extruder 140 around the banded single lumen tube 142 in an outer layer formation step.

[0063] The drawing step involves pulling the banded single lumen tube 142 through a die 146 of the same or a different extruder using a drawing machine (not shown).

[0064] The outer layer forming step includes periodically extruding a melt 144 of the first polymer material or the second polymer material through a die 146 around the banded single lumen tube 142 to form an output tube 148 having sections of single lumen tube and including regularly interspersed sections of layered tube.

[0065] The tapering step includes cyclically increasing the pulling speed of the output tube 148 with a pulling machine and returning the pulling speed of the output tube 148 to a constant pulling speed to form a tapered first section 110 and a constant diameter second section 112 of each of the catheter tubes.

[0066] The lumen forming step includes forming one or more additional lumens in the lumen of the single lumen tube by injecting air into the melt 144 of the first or second polymer material while extruding the melt 144 of the first or second polymer material through a die 146 around the banded single lumen tube 142 in the outer layer forming step.

[0067] The catheter tube cutting step includes periodically cutting the output tube 148 immediately before each of the regularly interspersed layered tube sections having sections of single lumen tube, thereby forming catheter tubes, each of which has a first catheter tube section 110 terminating in a catheter tip 114 reinforced with one of the reinforcement bands 122.

[0068] The opening cutting step includes cutting (e.g., laser cutting) one or more openings in the catheter tube to correspondingly establish one or more openings for one or more additional lumens (e.g., secondary lumen opening 136, tertiary lumen opening 138, etc.).

[0069] Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be understood by those skilled in the art. In the broader aspects, these adaptations and / or modifications are also encompassed. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A RICC as a rapid insertion central venous catheter, A catheter tube, a first section in the distal portion of the catheter tube, the first section terminating distally in a catheter tip reinforced with a reinforcement band therein; a second section proximal to the first section; and a catheter hub coupled to a proximal portion of the catheter tube; a plurality of extension legs extending from the catheter hub, the extension legs being equal in number to the plurality of lumens extending through the RICC; RICC is equipped with:

2. 2. The RICC according to claim 1, A RICC in which the reinforcement band has sufficient stiffness along its length to support aspiration through the RICC without collapsing the catheter tip.

3. 3. The RICC according to claim 1 or 2, A RICC in which the reinforcement band has sufficient stiffness over its length to prevent buckling of the catheter tip when the RICC is inserted into a needle path, optionally over an access guidewire, into a vessel lumen.

4. 3. The RICC according to claim 1 or 2, The reinforcement band is formed from a thermoplastic polymer or metal onto which the first section of the catheter tubing is molded or extruded.

5. 5. The RICC according to claim 4, the reinforcement band is formed from a thermoplastic polymer; The thermoplastic polymer is selected from thermoplastic polyurethanes, carbonate-based thermoplastic polyurethanes, polyamides, and polyamide-block-polyether copolymers, RICC.

6. 5. The RICC according to claim 4, The reinforcing band is formed from metal, RICC, wherein the metal is selected from stainless steel, titanium, and nitinol.

7. 3. The RICC according to claim 1 or 2, The RICC is a three-lumen catheter including a trifurcated catheter hub as a catheter hub and three extension legs for multiple extension legs; An RICC, wherein each of the three extension legs includes a luer connector coupled to a proximal portion of the extension leg.

8. 8. The RICC according to claim 7, a primary lumen extending from an opening at the proximal end of the first luer connector to an opening at the catheter tip; a secondary lumen extending from an opening at the proximal end of the second luer connector to a secondary lumen opening at a distal portion of the second section of the catheter tube; a tertiary lumen extending from an opening at the proximal end of the third luer connector to a tertiary lumen opening in a distal portion of the second section of the catheter tubing proximal to the secondary lumen opening; Including RICC.

9. 9. The RICC according to claim 8, The secondary and tertiary lumens each terminate at the distal end of the second section of the catheter tubing, RICC.

10. 10. The RICC according to claim 9, The RICC, wherein the proximal end of the first section of catheter tubing is adhered to the distal end of the second section of catheter tubing.

11. 3. The RICC according to claim 1 or 2, the first section of the catheter tube is formed from a first polymeric material having a first durometer; The second section of the catheter tube is formed from a second polymeric material having a second durometer less than the first durometer.

12. 12. The RICC according to claim 11, Each of the first and second polymeric materials is a polyurethane. RICC.

13. 9. The RICC according to claim 8, The secondary and tertiary lumens each terminate within the intermediate portion of the first section of the catheter tubing.

14. 14. The RICC according to claim 13, an outer layer of the catheter tube is extruded onto the inner layer of the catheter tube; The inner layer of the catheter tube includes a reinforcing band thereon, RICC.

15. 3. The RICC according to claim 1 or 2, the first section of the catheter tube tapers from the second section of the catheter tube toward the catheter tip; The second section of the catheter tubing has a constant outer diameter, RICC.

16. A catheter tube, a first section in the distal portion of the catheter tube having a single catheter tube lumen therethrough and terminating distally in a catheter tip reinforced with a reinforcement band therein; a second section of catheter tubing proximal to the first section of catheter tubing, the second section including the same catheter tubing lumen as the first section of catheter tubing and having two or more catheter tubing lumens therethrough; A catheter tube comprising:

17. The catheter tube according to claim 16, The catheter tube, wherein the stiffening band has sufficient stiffness along its length to support aspiration through the catheter tube without collapsing the catheter tip.

18. The catheter tube according to claim 16 or 17, The catheter tube, wherein the stiffening band has sufficient stiffness over its length to prevent buckling of the catheter tip when the catheter tube is inserted into a needle path, optionally over an access guidewire, into the vessel lumen.

19. The catheter tube according to claim 16 or 17, A catheter tube, wherein the reinforcement band is formed from a thermoplastic polymer or metal, onto which the first section of the catheter tube is molded or extruded.

20. 20. The catheter tube according to claim 19, the reinforcement band is formed from a thermoplastic polymer; The catheter tube, wherein the thermoplastic polymer is selected from thermoplastic polyurethanes, carbonate-based thermoplastic polyurethanes, polyamides, and polyamide-block-polyether copolymers.

21. 20. The catheter tube according to claim 19, The reinforcing band is formed from metal, The catheter tube, wherein the metal is selected from stainless steel, titanium, and nitinol.

22. The catheter tube according to claim 16 or 17, the catheter tube is a three-lumen catheter tube; The three-lumen catheter tube is a primary catheter tube lumen corresponding to a catheter tube lumen passing through both the first and second sections of the catheter tube and extending from an opening at the proximal end of the second section of the catheter tube to an opening at the catheter tip; a secondary catheter tube lumen extending from an opening at the proximal end of the second section of the catheter tube to a secondary lumen opening at a distal portion of the second section of the catheter tube; a tertiary catheter tube lumen extending from an opening at the proximal end of the second section of the catheter tube to a tertiary lumen opening at a distal portion of the second section of the catheter tube proximal to the secondary lumen opening; a catheter tube.

23. The catheter tube according to claim 22, A catheter tube, wherein each of the secondary and tertiary catheter tube lumens terminates at a distal end of the second section of the catheter tube.

24. The catheter tube according to claim 23, A catheter tube, wherein a proximal end of a first section of the catheter tube is adhered to a distal end of a second section of the catheter tube.

25. The catheter tube according to claim 16 or 17, the first section of the catheter tube is formed from a first polymeric material having a first durometer; The catheter tube, wherein the second section of the catheter tube is formed from a second polymeric material having a second durometer less than the first durometer.

26. 26. The catheter tube according to claim 25, The catheter tube, wherein each of the first and second polymeric materials is polyurethane.

27. The catheter tube according to claim 22, A catheter tube, wherein each of the secondary and tertiary catheter tube lumens terminates within an intermediate portion of the first section of the catheter tube.

28. 28. The catheter tube of claim 27, an outer layer of the catheter tube is extruded onto the inner layer of the catheter tube; The inner layer of the catheter tube includes a reinforcing band thereon.

29. The catheter tube according to claim 16 or 17, the first section of the catheter tube tapers from the second section of the catheter tube toward the catheter tip; The second section of the catheter tube has a constant outer diameter.

30. 1. A method for making a catheter tube, comprising: forming an inner layer of the catheter tube by extruding a single lumen tube of a first polymeric material using an extruder; banding the single lumen tube with a plurality of reinforcing bands at regular intervals to form a banded single lumen tube, the reinforcing bands being regularly interspersed along the banded single lumen tube; pulling the banded single lumen tubing through the same or a different die using a pulling machine; periodically extruding a melt of the first polymer material or the second polymer material through a die around the banded single lumen tube to form an output tube including sections of layered tube regularly interspersed with sections of single lumen tube; periodically cutting the output tube immediately before each section of layered tubing regularly interspersed with sections of single-lumen tubing, thereby forming a catheter tube; A method comprising:

31. The method of claim 30 further comprising: applying an adhesive layer onto the single lumen tubing before extruding a melt of the first or second polymeric material through a die and around the banded single lumen tubing; A method comprising:

32. The method according to claim 30 or 31 further comprises: forming one or more additional lumens in the lumen of the single lumen tube by injecting air into the melt of the first or second polymeric material while extruding the melt of the first or second polymeric material through a die and around the banded single lumen tube; A method comprising:

33. The method of claim 32 further comprising: cutting one or more openings in the catheter tube to correspondingly establish one or more openings for one or more additional lumens. A method comprising:

34. The method according to claim 30 or 31 further comprises: periodically increasing the speed at which the output tube is pulled using a pulling machine; returning the pulling speed of the output tube to a constant pulling speed to form a tapered first section and a constant diameter second section of each catheter tube; A method comprising:

35. 35. The method of claim 34, The method wherein the first section of each catheter tube terminates in a catheter tip reinforced with one of the reinforcement bands.

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