Apparatus and method for forming the tip of a rapid insertion central venous catheter (RICC) - Patent Application 20070233633

Abstract

A method of forming a rapid insertion central venous catheter, the method comprising the steps of providing a catheter body section (232) having a primary lumen (210), a secondary lumen (212), and a tertiary lumen (213), each extending longitudinally, and placing a distal end of the catheter body into a die (300), the die having a first mandrel (310) engaging the primary lumen, a second mandrel (312) engaging the secondary lumen, and a third mandrel (314) engaging the tertiary lumen. and melting a polymeric material disposed within the die cavity to form an expansion section (234) coupled to the distal tip of the catheter body, the expansion section defining a tapered outer contour and including a secondary lumen opening (218) and a tertiary lumen opening (220), the secondary lumen opening disposed in the sidewall and in communication with the secondary lumen, and the tertiary lumen opening disposed in the sidewall and in communication with the tertiary lumen.

Description

[Technical field]

[0001] The present disclosure relates to devices and methods for forming the tips of rapid insertion central venous catheters (RICCs). [Background technology]

[0002] The rapid insertion central catheter (RICC) system includes a RICC catheter having a catheter body defining two or more lumens and an access site extending from the catheter body and defining a single lumen. The RICC further includes an expansion site disposed between the access site and the catheter body site and defining a tapered outer contour. The RICC configuration allows a physician to access the vasculature, expand the access site, and deploy the catheter body defining one or more lumens in a single motion. Conventional catheter deployment techniques require such steps to be performed separately, necessitating repeated introduction and removal of multiple tools and medical devices. The RICC system thus simplifies complex and cumbersome deployment techniques to reduce introduction of pathogens and reduce overall procedure time.

[0003] However, to form a RICC catheter that is required to perform several different functions, it is necessary to join three different structures, the catheter body, the expansion site, and the access site, while maintaining a smooth abluminal surface. Each of the three different structures is required to exhibit different mechanical properties to fulfill its role in the deployment process, and therefore is often formed of different materials. Conventional manufacturing techniques result in the formation of bumps or ridges adjacent the junction of two or more of these structures. If the bumps occur on the outer surface, they may trap a portion of the skin at the insertion site, inhibiting distal advancement of the RICC and impeding the deployment procedure. If the bumps occur within the lumen, they may trap the tip of a guidewire or the like, preventing the guidewire from moving within the lumen. Additional machining or milling steps are required to remove such bumps or ridges and provide a smooth surface, but such secondary manufacturing steps increase cost and complexity.

[0004] Additionally, conventional manufacturing techniques often require secondary machining or milling procedures to form openings in communication with the lumen. The openings are formed in the sidewall or distal end of the catheter after it is formed. Forming openings in a tapered outer surface while maintaining a smooth abluminal surface can be particularly difficult. Errors in these secondary machining procedures can lead to waste in the manufacturing process or failure of the device. Thus, openings are often formed distal or proximal to the tapered region and perpendicular to the axis of the lumen. Summary of the Invention

[0005] Briefly summarized, embodiments disclosed herein relate to distal tip structures for catheters, such as rapid insertion central catheters (RICCs), and related manufacturing methods. The embodiments relate to forming complex distal tip structures comprising one or more different materials while improving manufacturing efficiency. The embodiments relate to providing RICC distal tip structures with smooth abluminal and luminal surfaces with little or no secondary machining steps to remove ridges or protuberances, or forming openings. Additionally, the embodiments relate to forming openings in tapered surfaces during the primary manufacturing process. Such distal tip structures improve the effectiveness of the device, since they reduce the longitudinal length between the openings and the distal tip. Additionally, the reduced number of manufacturing steps reduces costs and waste, while improving manufacturing efficiency.

[0006] Disclosed herein is a method of forming a rapid insertion central venous catheter, the method comprising the steps of providing a catheter body section having a primary lumen, a secondary lumen, and a tertiary lumen each extending longitudinally, placing a distal end of the catheter body into a die, the die having a first mandrel engaging the primary lumen, a second mandrel engaging the secondary lumen, and a third mandrel engaging the tertiary lumen, and melting a polymeric material disposed within a cavity of the die to form an expansion section coupled to the distal tip of the catheter body, the expansion section defining a tapered outer profile and including a secondary lumen opening and a tertiary lumen opening, the secondary lumen opening disposed in a sidewall and communicating with the secondary lumen, and the tertiary lumen opening disposed in a sidewall and communicating with the tertiary lumen.

[0007] In some embodiments, the method further comprises forming an access site integrally with the dilation site and extending from a distal end of the dilation site, the access site defining a single lumen in communication with the primary lumen and extending to a primary lumen opening disposed at a distal tip of the access site.

[0008] In some embodiments, the access site and the expansion site are formed of a first polymeric material and the catheter body is formed of a second polymeric material, the first polymeric material exhibiting a harder durometer than the second polymeric material.

[0009] In some embodiments, the first mandrel includes a collar disposed at a distal end of the first mandrel, the collar defining an outer diameter equal to an outer diameter of the access site. In some embodiments, the method further comprises positioning a proximal end of the access site within a receptacle of the expansion site defined by a collar of the first mandrel, and securing the access site to the expansion site using adhesive, bonding, solvent bonding, or welding.

[0010] In some embodiments, the access site is formed from a first polymeric material and the catheter body is formed from a second polymeric material, the first polymeric material exhibiting a harder durometer than the second polymeric material.

[0011] In some embodiments, the expansion portion is formed from one of a first polymeric material, a second polymeric material, and a third polymeric material having a durometer harder than the second polymeric material and softer than the first polymeric material.

[0012] In some embodiments, the melting step further comprises applying one of radio frequency (RF) energy or thermal energy to melt the polymeric material. In some embodiments, one or both of the secondary and tertiary lumen openings are located at a longitudinal midpoint between the proximal and distal ends of the expansion region.

[0013] In some embodiments, the secondary lumen opening and the tertiary lumen opening are disposed equal longitudinal lengths from the distal tip of the rapid insertion central venous catheter. In some embodiments, the method further includes forming an introduction opening disposed proximal to one or both of the secondary and tertiary lumen openings and in communication with the primary lumen, the introduction opening configured to receive an access needle therethrough, the distal tip of the access needle extending through the primary lumen opening disposed at the distal tip of the rapid insertion central venous catheter.

[0014] In some embodiments, providing the catheter body further comprises extruding or cutting the catheter body section to a predetermined length and connecting the proximal end of the catheter body to one or more catheter hubs and one or more extension legs.

[0015] A rapid insertion central venous catheter system comprising a rapid insertion central venous catheter comprising: a catheter body defining a primary lumen, a secondary lumen, and a tertiary lumen and including an introduction opening, the introduction opening including an introduction opening disposed in a sidewall and in communication with the primary lumen; an expansion section extending distally from the catheter body and defining a tapered outer contour, the expansion section defining a secondary lumen opening disposed in the sidewall and in communication with the secondary lumen, and a tertiary lumen opening disposed in the sidewall and in communication with the tertiary lumen; an access section extending from the expansion section, the access section including a primary lumen opening disposed at a distal tip of the access section and in communication with the primary lumen; and a needle extending through the introduction opening and a distal portion of the primary lumen, the distal tip of the needle extending through the primary lumen opening.

[0016] In some embodiments, the secondary lumen opening and the tertiary lumen opening are disposed equal longitudinal lengths from the distal tip of the access site. In some embodiments, the longitudinal length of the access site is less than the longitudinal length of the expansion site.

[0017] In some embodiments, the access site is formed of a first material and the catheter body is formed of a second material having a softer durometer than the first material. In some embodiments, the expansion region is formed from one of a first material, a second material, and a third material having a durometer harder than the second material and softer than the first material.

[0018] In some embodiments, the expansion section and the access section are integrally formed as a single monolithic piece and fused to the catheter body using RF welding. In some embodiments, the expansion site is fused to the catheter body using RF welding and defines a receptacle at a distal end, the receptacle having a diameter equal to the outer diameter of the access site, and the proximal end of the access site is coupled to the receptacle using adhesives, bonding, solvent bonding, or welding.

[0019] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0020] [Figure 1] 1 is a side view of an exemplary RICC placement system, according to embodiments disclosed herein. [Diagram 2] 2 is an enlarged detailed view of a distal portion of the RICC of FIG. 1 according to an embodiment disclosed herein. [Figure 3A] 3 is a cross-sectional view of the distal portion of FIG. 2 according to an embodiment disclosed herein. [Figure 3B] 3 is a cross-sectional view of the distal portion of FIG. 2 according to an embodiment disclosed herein. [Figure 3C] 3 is a cross-sectional view of the distal portion of FIG. 2 according to an embodiment disclosed herein. [Figure 3D] 3 is a cross-sectional view of the distal portion of FIG. 2 according to an embodiment disclosed herein. [Figure 4A]1 is a perspective view of a RICC placement system according to an embodiment disclosed herein. [Figure 4B] 4B is a side view of the RICC placement system of FIG. 4A according to an embodiment disclosed herein. [Diagram 5] 4B is a distal end view of the RICC of the RICC deployment system of FIG. 4A according to an embodiment disclosed herein. [Figure 6A] FIG. 2 is a perspective view of a distal portion of a RICC according to an embodiment disclosed herein. [Figure 6B] 1 is a plan view of a distal portion of a RICC according to an embodiment disclosed herein. [Figure 6C] 2A is a longitudinal cross-sectional view of a RICC according to an embodiment disclosed herein. [Figure 7A] FIG. 2 is a vertical cross-sectional view of a die along its longitudinal axis according to an embodiment disclosed herein. [Figure 7B] FIG. 7B is a horizontal cross-sectional view along the longitudinal axis of the die of FIG. 7A according to an embodiment disclosed herein. [Figure 7C] 7B is a lateral cross-sectional view of the die of FIG. 7A according to an embodiment disclosed herein. [Figure 8A] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. [Figure 8B] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. [Figure 8C] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. [Figure 8D] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. [Figure 8E] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. [Figure 8F] 1A-1C illustrate an exemplary method of forming a catheter tip according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 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 that can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0022] 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 among 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. Designations such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply any particular fixed position, orientation, or direction, for example. Rather, such designations are used to indicate relative positions, orientations, or directions, for example. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include the plural.

[0023] In the following description, the terms "or" and "and / or" as used herein should be construed as inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means any of the following: "A, B, C", "A and B", "A and C", "B and C", "A, B and C". Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way inherently mutually exclusive.

[0024] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is closest to the physician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter that is closest to the physician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes the end of the catheter that is closest to the physician when the catheter is used on a patient. Although a proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or length of a catheter.

[0025] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is near or within the patient when the catheter is in use with the patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is near or within the patient when the catheter is in use with the patient. For example, a "distal end" of a catheter includes an end of the catheter that is near or within the patient when the catheter is in use with the patient. Although a distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or length of the catheter.

[0026] To aid in illustrating the embodiments described herein, as shown in FIG. 4A, a longitudinal axis extends substantially parallel to the axial length of the catheter. A transverse axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and transverse axes. A horizontal plane is defined by the longitudinal and transverse axes. A vertical plane extends perpendicular to the horizontal plane.

[0027] 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 described herein, there is a need to overcome certain problems in the manufacture of rapid insertion central venous catheters (RICCs). For example, a RICC may include a multi-lumen catheter body section and transition to a single-lumen access section adjacent the distal end. The transition between these sections can be very difficult to achieve without creating edges or bumps on the outer surface of the RICC that could catch the patient's skin around the insertion site and interfere with subcutaneous placement of the RICC. Thus, a RICC and method of manufacture thereof that meets the aforementioned needs are also disclosed herein.

[0028] Rapid insertion central venous catheter system 1-3D illustrate an exemplary rapid insertion central venous catheter (RICC) placement system (system) 100, according to some embodiments. As shown, the system 100 generally includes a rapid insertion central venous catheter (RICC) 102, an introducer needle (needle) 104, and one or more guidewires, such as an access guidewire 106 and a placement guidewire 108.

[0029] In one embodiment, the RICC 102 may be 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.). As shown in FIG. 1 and FIG. 3D, the RICC 102 is a three-lumen RICC that includes a set of three lumens. Such a set of three lumens includes a primary lumen 110 (e.g., a distal lumen), a secondary lumen 112 (e.g., a middle lumen), and a tertiary lumen 114 (e.g., a proximal lumen).

[0030] 1, the RICC 102 further includes a hub 126 disposed at a proximal end and one or more extension legs 128 extending proximally from the hub 126. Each extension leg 128 is in fluid communication with a lumen 110, 112, or 114 of the RICC 102. For example, as shown, a first extension leg 128A is in fluid communication with the distal lumen 110, a second extension leg 128B is in fluid communication with the middle lumen 112, and a third extension leg 128C is in fluid communication with the proximal lumen 114.

[0031] Regardless of whether the RICC 102 is single-lumen or multi-lumen, the RICC 102 includes at least a primary lumen 110. The primary lumen 110 typically extends from a proximal end of the RICC 102 to a distal end of the RICC 102. For example, the primary lumen 110 extends from an opening of a corresponding luer connector to a primary lumen opening 116 at a distal end of the catheter tube 124 (e.g., a rigid portion of the catheter tube 124 or a first portion (access site 130) of the catheter tube 124) described herein. When the RICC 102 has more than one lumen, the RICC 102 further includes at least a secondary lumen 112. The secondary lumen 112 typically extends from a proximal end of the RICC 102 to a distal portion of the RICC 102. For example, the secondary lumen 112 extends from the opening of a corresponding Luer connector to a secondary lumen opening 118 in a distal portion of the catheter tube 124 proximal to the primary lumen opening 116 (e.g., in the soft portion of the catheter tube 124 or in a second section (catheter body 132) of the catheter tube 124).

[0032] When the RICC 102 has three or more lumens, the RICC 102 further includes at least a tertiary lumen 114. The tertiary lumen 114 typically extends from a proximal end of the RICC 102 to a distal portion of the RICC 102. For example, the tertiary lumen 114 extends from an opening of a corresponding luer connector to a tertiary lumen opening 120 at a distal portion of the catheter tube 124 proximal to the secondary lumen opening 118 (e.g., at a soft portion of the catheter tube 124 or a first portion 132 of the catheter tube 124). Notwithstanding the above, each lumen of the secondary lumen 112 and the tertiary lumen 114 may extend slightly distal to the secondary lumen opening 118 and the tertiary lumen opening 120, respectively, to allow for different manufacturing methods.

[0033] In one embodiment, the longitudinal length between the primary lumen opening 116 and the secondary lumen opening 118 may be a first length (L1). In one embodiment, the longitudinal length between the primary lumen opening 116 and the tertiary lumen opening 120 may be a second length (L2). In one embodiment, the first length (L1) may be longer than the second length (L2). Thus, the difference between the first length (L1) and the second length (L2) may be a third length (L3). In one embodiment, the first length (L1) or the second length (L2) may be 3 cm to 10 cm. In one embodiment, the first length (L1) or the second length (L2) may be substantially 7 cm. However, it is understood that there may be lengths longer or shorter than this.

[0034] In one embodiment, the RICC 102 includes a dedicated introduction opening 122 to receive the insertion of the introducer needle 104 for connecting the RICC 102 to the introducer needle 104 within the system 100. However, the RICC 102 does not have to include a dedicated introduction opening such as the introduction opening 122. In fact, the secondary lumen opening 118 or the tertiary lumen opening 120 may function as the introduction opening 122 in some embodiments. This requires a different manner of connecting the RICC 102 to the introducer needle 104. Alternatively, if the RICC 102 is of the single lumen type, an introduction opening may be formed as needed by puncturing the catheter tube 124 with the introducer needle 104.

[0035] The RICC 102 further includes an introduction lumen that coincides with the distal portion of the primary lumen 110. In other words, the introduction lumen is the introduction portion of the primary lumen 110 of the RICC 102. In the RICC 102, the introduction lumen is the distal portion of the primary lumen 110 that extends from the introduction opening 122 to the primary lumen opening 116. The introduction opening 122, which may be distal to the secondary lumen opening 118, between the secondary lumen opening 118 and the tertiary lumen opening 120, or proximal to the tertiary lumen opening 120, opens directly into the proximal end of the introduction portion of the primary lumen 110 of the RICC 102. In the case of a RICC without the introduction opening 122, the introduction lumen is the distal portion of the primary lumen 110 that extends from the secondary lumen opening 118, the tertiary lumen opening 120, or the puncture made by the introduction needle 104 to the primary lumen opening 116. Whether the introducer lumen extends from the secondary lumen opening 118, the tertiary lumen opening 120, or the puncture depends on which of the aforementioned openings accommodates the introducer needle 104. Neither the secondary lumen opening 118 nor the tertiary lumen opening 120 open directly into the proximal end of the introducer portion of the primary lumen 110 of the RICC without via an introducer opening 122. Instead, the introducer needle 104 punctures the partition between the secondary lumen 112 or the tertiary lumen 114 and the primary lumen 110 from the secondary lumen opening 118 or the tertiary lumen opening 120, respectively.

[0036] Figure 2 shows a distal portion of the catheter tube 124 of the RICC 102 of Figure 1, according to some embodiments. Figures 3A-3D show various cross sections of the catheter tube 124 of Figure 2, according to some embodiments.

[0037] The catheter tube 124 includes a rigid portion of the catheter tube 124 and a flexible portion of the catheter tube 124. "Rigid" and "flexible" are used in a relative sense in that the rigid portion of the catheter tube 124 is harder than the flexible portion of the catheter tube 124. The rigid portion of the catheter tube 124 includes a first single lumen portion or "access portion" 130 at a distal portion of the catheter tube 124. The flexible portion of the catheter tube 124 includes a second portion or "catheter body" 132 having one or more lumens and extending from a proximal portion to a distal portion of the catheter tube 124 but proximal to the access portion 130. In one embodiment, the enlarged portion 134 or expansion portion 134 of the catheter tube 124 may be formed of the same material as the access portion 130 and may have the same mechanical properties. In one embodiment, the expansion portion 134 of the catheter tube 124 may be formed of the same material as the catheter body portion 132 and may have the same mechanical properties. In one embodiment, the expansion section 134 of the catheter tube 124 may be formed of a third material that is different from the first material of the access site 130 and the second material of the catheter body section 132. In one embodiment, the third material may be softer than the relatively stiff first material and harder than the relatively stiff second material. In one embodiment, the third material may be softer than the second material of the catheter body section 132. In one embodiment, the third material may be harder than the first material of the access site 130.

[0038] In one embodiment, the aforementioned arrangement of the access site 130 of the catheter tube 124, the catheter body portion 132 of the catheter tube 124, and the expansion portion 134 has sufficient column strength to prevent buckling of the catheter tube 124 when inserted into an insertion site established by percutaneous puncture and advanced within the patient's vasculature. As described herein, the catheter tube 124 is shown with its distal portion, e.g., the introduction opening 122 through the side of the catheter tube 124 at the access site 130.

[0039] The access site 130 of the catheter tube 124 is at the distal portion of the catheter tube 124. The access site 130 includes a distal tip 136 having a relatively short taper that continues from the beveled tip 146 of the introducer needle 104 in the system 100 to the outer diameter of the remaining portion of the access site 130. The taper of the distal tip 136 is configured to immediately dilate tissue surrounding the percutaneous puncture established with the introducer needle 104 to the outer diameter of the remaining portion of the access site 130 of the catheter tube 124. The access site 130 also includes a proximal portion disposed and fixedly coupled (e.g., solvent bonded, adhesively, welded, etc.) to a receptacle 138 of the dilation site 134.

[0040] The access site 130 of the catheter tube 124 is formed of a first polymeric material having a first durometer (hardness). The first polymeric material may be polytetrafluoroethylene, polypropylene, or polyurethane, but is not limited to the aforementioned polymers. Polyurethane is advantageous in that the access site 130 of the catheter tube 124 remains relatively stiff at room temperature, but becomes more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis.

[0041] The catheter body section 132 of the catheter tube 124 extends from a proximal portion to a distal portion of the catheter tube 124, but is proximal to the access site 130 of the catheter tube 124. In one embodiment, the catheter body section 132 includes a distal end that is integral (e.g., RF welded) with the proximal end of the expansion section 134 and a proximal portion that is disposed within and fixedly coupled (e.g., solvent bonded, welded, glued, etc.) to the catheter hub 126.

[0042] The catheter body portion 132 of the catheter tube 124 is formed of a second polymeric material having a second durometer less than the first durometer. The second polymeric material may be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the aforementioned polymers. In addition to what has been discussed above about polyurethane at the access portion 130 of the catheter tube 124, polyurethane is advantageous in that it is less thrombogenic than some other polymers.

[0043] The expansion section 134 of the catheter tube 124 interconnects the access section 130 and the catheter body section 132 of the catheter tube 124. The expansion section 134 includes a receptacle 138 (see FIG. 8D) at a distal portion thereof. The receptacle 138 includes a proximal portion of the access section 130 of the catheter tube 124 disposed therein and fixedly coupled (e.g., solvent bonded, welded, glued, etc.). The proximal end of the expansion section 134 is integral (e.g., RF welded) with the distal end of the catheter body section 132 of the catheter tube 124. This effectively terminates, in embodiments, the lumens of the catheter body section 132 of the catheter tube 124 other than the primary lumen 110 (e.g., the intermediate and proximal lumens 112, 114) from passing through the expansion section 134.

[0044] In one embodiment, the expansion section 134 also includes a taper along its length from the distal end to the proximal end configured to instantly expand the tissue surrounding the percutaneous puncture to the outer diameter of the catheter body section 132 of the catheter tube 124. The abluminal surface of the expansion section 134 transitions smoothly from the abluminal surface of the proximal portion of the access section 130 without edges that may catch the skin when the RICC 102 is inserted into the patient's insertion site. In addition to having minimal to negligible edges, the edges may include a solvent interdiffusion of the first polymeric material with the polymeric material of the expansion section 134. This provides a smooth transition from the access section 130 to the expansion section 134 of the catheter tube 124.

[0045] In one embodiment, the expansion section 134 of the catheter tube 124 is formed of a second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer, and the second polymeric material may be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the aforementioned polymers.

[0046] The access section 130 of the catheter tube 124 is formed of a first polymeric material having a first durometer. The catheter body section 132 of the catheter tube 124 is formed of a second polymeric material having a second durometer that is less than the first durometer. The expansion section 134 of the catheter tube 124 is formed of the second polymeric material or a third polymeric material having a third durometer that is closer to the second durometer than the first durometer. Since the second and third durometers are less than the first durometer, the soft section of the catheter tube 124, including the second section of the catheter tube 124 and the expansion section 134, is softer than the hard section of the catheter tube 124, including the access section of the catheter tube 124. In other words, the first durometer is greater than the second and third durometers. The first durometer is greater than the second and third durometers. Thus, the rigid portion of the catheter tube 124 including the access section of the catheter tube 124 is stiffer than the flexible portion of the catheter tube 124 including the second portion of the catheter tube 124 and the expansion section 134 .

[0047] The first durometer of the first polymeric material, the second durometer of the second polymeric material, and the third durometer of the third polymeric material may be of different scales (e.g., Type A or Type D). It should be understood that the second durometer or the third durometer may not be numerically smaller than the first durometer. In other words, the first durometer material may not be numerically larger than the second durometer and the third durometer with respect to the different scales. However, the hardness of the second or third polymeric material may still be lower than the hardness of the first polymeric material. Or, the hardness of the first polymeric material may still be higher than the hardness of the second or third polymeric material. The reason is that the different scales, each ranging from 0 to 100, are intended to characterize different materials in a group of materials having similar hardness.

[0048] Notwithstanding the above, the access portion 130 of the catheter tube 124, the catheter body portion 132 of the catheter tube 124, and the expansion portion 134 may be formed of the same polymeric material or different polymeric materials having substantially equal durometers, so long as the column strength of the catheter tube 124 is sufficient to prevent buckling of the catheter tube 124 when inserted into an insertion site established by percutaneous puncture and advanced within the patient's vasculature.

[0049] In one embodiment, each extension leg of the one or more extension legs 128 typically includes a luer connector coupled thereto through which the extension leg, and thus the extension leg lumen, may be connected to another medical device. In one embodiment, the introducer needle 104 includes a shaft 142, a needle hub 144 about a proximal portion of the shaft 142, and a beveled tip 146 at a distal portion of the shaft 142.

[0050] When the system 100 is in a ready-to-deploy state, the introducer needle 104 or its shaft 142 is positioned in the introducer lumen through the introducer aperture 122 (if present). Thus, the beveled tip 146 of the introducer needle 104 extends beyond the distal end of the access site 130 of the catheter tube 124 to establish a percutaneous puncture. The access guidewire 106 has a sufficient length to advance a distal portion of the RICC 102 into the vessel lumen and maintain access after establishing access to the vessel lumen by advancing the access guidewire 106 a sufficient distance into the vessel lumen.

[0051] The access guidewire 106 is disposed within the needle lumen of the introducer needle 104 when the system 100 is in at least a ready-to-deploy state. In effect, the distal end of the access guidewire 106 is proximal to the beveled tip 146 of the introducer needle 104, but distal to the dilation site 134. This allows the distal end of the access guidewire 106 to be immediately advanced beyond the beveled tip 146 of the introducer needle 104 and into the vessel lumen upon establishing access to the vessel lumen.

[0052] The access guidewire 106 includes a stop 148 (e.g., hub, ball, slug, etc.) about a proximal portion of the access guidewire 106 that forms a stop end (e.g., hub end, ball end, slug end, etc.) of the access guidewire 106. The stop end of the access guidewire 106 is larger than any opening in the RICC 102 or its catheter tube 124, thereby providing a distal limit for advancement of the access guidewire 106 within the RICC 102. The placement guidewire 108 includes an atraumatic tip (e.g., a coiled or partially coiled tip) and has a length sufficient to advance the placement guidewire 108 up to the lower third of the superior vena cava ("SVC") of the heart.

[0053] When the system 100 is in at least a ready-to-deploy state, the placement guidewire 108 is disposed within the primary lumen 110 of the RICC 102 such that the distal end of the placement guidewire 108 is proximal to the introducer opening 122 and distal to the catheter hub 126. This allows the distal end of the placement guidewire 108 to be immediately advanced into the vessel lumen upon removal of the introducer needle 104 or its shaft 142 from the introducer lumen. In fact, the placement guidewire 108 cannot be advanced distal to the introducer lumen due to the presence of the introducer needle 104 or shaft 142, at least in the ready-to-deploy state of the system 100.

[0054] The placement guidewire 108 includes a stop 150 (e.g., hub, ball, slug, etc.) about a proximal portion of the placement guidewire 108 that forms a stop end (e.g., hub end, ball end, slug end, etc.) of the placement guidewire 108. The stop end of the placement guidewire 108 is larger than the proximal end opening at the luer connector of the extension leg in which the placement guidewire 108 is placed. This provides a distal limit for advancement of the placement guidewire 108 within the RICC 102.

[0055] 4A and 4B illustrate one embodiment of a RICC 202 configured for use with the RICC system 100 described herein. The RICC 202 generally includes a single-lumen access site 230 disposed distally and defining a first diameter (d1) and a multi-lumen catheter body site 232 disposed proximally and defining a second diameter (d2). The first diameter (d1) may be smaller than the second diameter (d2). The RICC 202 further includes an expansion site 234 disposed between the access site 230 and the catheter body site 232 and may define a tapered abluminal surface extending between the first diameter (d1) and the second diameter (d2), as described herein. In one embodiment, one or more of the intermediate or secondary lumen opening 218 and the proximal or tertiary lumen opening 220 are formed within the tapered expansion site 134. In one embodiment, the secondary lumen opening 218 and the tertiary lumen opening 220 are disposed at equal longitudinal lengths (L4) from the primary lumen opening 216. In one embodiment, the length (L4) is between 0.1 cm and 7 cm. However, it is understood that greater or lesser distances may be present. In one embodiment, the introduction opening 122 is disposed proximal to the expansion region 234, i.e., proximal to the secondary lumen opening 218 and the tertiary lumen opening 220, and communicates with the primary lumen 210.

[0056] Advantageously, as shown in Figures 6A-6C, with the secondary lumen opening 218 and the tertiary lumen opening 220 located within the tapered expansion section 234 and the introduction opening 122 located proximal to the expansion section 234, the longitudinal length of the access section 230 may be shortened to shorten the distance (L4) between the primary lumen opening 216 and one or both of the secondary lumen opening 218 and the tertiary lumen opening 230. This may reduce the distance between the introduction site of the first fluid introduced at the primary lumen opening 216 and the second or third fluid introduced at the secondary lumen opening 218 or the tertiary lumen opening 220, respectively. The positioning of the distal tip of the RICC catheter 202 within the vasculature may be important. If the fluid is introduced into an opening located proximal to the target location within the vasculature, such as the secondary lumen opening 218 or the tertiary lumen opening 220, the effectiveness of the treatment is reduced. Similarly, if the distal tip 236 of the catheter 202, substantially at the primary lumen opening 216, is forward too far (i.e., distal to the target location), the distal tip 236 may cause complications to the patient. For example, the distal tip 236 may be advanced into the atrium of the heart causing arrhythmia. Thus, decreasing the longitudinal distance between the primary lumen opening 216 and one or both of the secondary lumen opening 218 and the tertiary lumen opening 220 may increase the precision of placing fluid at the target location within the vasculature.

[0057] 7A-7C show details of a die 300 used in a manufacturing process to form at least a portion of a RICC catheter 202 as described herein. The die 300 generally includes a body 302 defining a cavity 304 extending between a proximal end 306 of the body 302 and a distal end 308 of the body 302. In one embodiment, an inner surface of the cavity 304 defines a shape that matches an abluminal surface of a portion of the RICC 202, such as a portion of the access site 230, the catheter body site 232, the expansion site 234, or a combination thereof. For example, the cavity 304 includes a tapered cavity 334 that defines a tapered inner contour. In one embodiment, the tapered cavity 334 extends between a first diameter (d1) and a second diameter (d2). Thus, the tapered inner contour of the tapered cavity 334 matches the tapered outer contour of the expansion site 234 of the RICC 202.

[0058] In one embodiment, the cavity 304 further includes a catheter section 332 defining a cylindrical inner contour. The inner diameter of the catheter section 332 may correspond to the outer diameter, or second diameter (d2), of the catheter body 232 of the RICC 202. In one embodiment, the cavity 304 further includes an access site cavity (not shown) defining a cylindrical inner contour. The inner diameter of the access site cavity corresponds to the outer diameter, or first diameter (d1), of the access site 230 of the RICC 202.

[0059] In one embodiment, the die 300 further includes one or more mandrels. As described in more detail herein, the mandrels extend substantially longitudinally through the cavity 304 and are configured to define a portion of the one or more lumens 210, 212, 214. For example, the die 300 includes a primary mandrel 310 that extends between the proximal end 306 and the distal end 308 and is configured to define a portion of the primary lumen 310. The die 300 further includes one of a secondary mandrel 312 and a tertiary mandrel 314. The secondary mandrel 312 and the tertiary mandrel 314 are configured to extend from an inner surface of the cavity 304 to the proximal end 306 of the body 302 and to define a portion of one of the secondary lumen 212 and the tertiary lumen 214, respectively. In one embodiment, one of the secondary mandrel 312 and the tertiary mandrel 314 extends from a wall of the tapered cavity 334 of the cavity 304. In one embodiment, the secondary mandrel 312 and the tertiary mandrel 314 are configured to form one of the secondary lumen opening 218 and the tertiary lumen opening 220, as described in more detail herein.

[0060] method 8A-8F illustrate an exemplary method of forming a catheter tip for the RICC 202, referred to as "tipping." Advantageously, the tipping process may form a portion of the distal end of the RICC 202. The RICC 202 includes one or more of an access site 230, a catheter body 232, an expansion site 234, or a combination thereof, formed from one or more of a first material, a second material, or a third material, or a combination thereof, as described herein. Each of the access site 230, the catheter body 232, and the expansion site 234 may exhibit different mechanical properties and have different functions in the placement procedure while maintaining a smooth abluminal surface. Additionally, the embodiments described herein provide a smooth transition between the inner surfaces of one or more lumens 210, 212, 214. This solves the difficulty of the guidewire getting caught between the luminal surfaces of the access site 230, the expansion site 134, and the catheter body site 232.

[0061] 8A, a catheter body section 232 may be provided by first obtaining or forming a catheter body section 232 of a RICC 202. The catheter body section 232 may be formed of a second polymeric material having a second durometer. The catheter body section 232 may be formed, for example, by extruding the catheter body section 232 and cutting the catheter body section 232 to an appropriate length. The catheter body section 232 may be single lumen or multi-lumen having one or more additional lumens relative to the primary lumen 210.

[0062] 8A also shows a die 300 including one or more mandrels 310, 312, 314, as described herein. The distal end of the catheter body section 232 is longitudinally inserted into the proximal end of the cavity 304. More specifically, the distal end of the catheter body section 232 is received within the catheter section 332 of the cavity 304. The inner diameter of the catheter section 332 of the cavity 304 is equal to or slightly smaller than the outer diameter of the distal end of the catheter body section 232, thereby engaging the catheter body section 232 with an interference fit.

[0063] In one embodiment, one or more of the mandrels 310, 312, 314 extend to the proximal end 306 of the die 300. In one embodiment, one or more of the mandrels 310, 312, 314 extend to a point distal to the proximal end 306 of the die 300. In one embodiment, the proximal end of one of the mandrels 310, 312, 314 engages the distal end of one of the lumens 210, 212, 214 with an interference fit while retaining the catheter body section 232 within the die 300. For example, the primary mandrel 310 engages the primary lumen 210 of the catheter body 232. The secondary mandrel 312 engages the secondary lumen 212 of the catheter body 232. The tertiary mandrel 314 engages the tertiary lumen 214 of the catheter body 232. In one embodiment, the cross-sectional shape of the mandrels 310, 312, 314 is equal to or slightly larger than the cross-sectional shape of the corresponding lumens 210, 212, 214 to provide an interference fit engagement with the lumens.

[0064] As shown in FIG. 8B, with the proximal end of the catheter body section 232 engaged with the die 300, the material 80, e.g., one of the first polymeric material, the second polymeric material, or the third polymeric material, may be introduced into the cavity 304. The polymeric material may be provided in a flowable or semi-flowable state, as a single slug, tube, rod, or cylinder of material, or as a powder or granular material. In one embodiment, the material 80 may be disposed in the cavity 304 before the catheter body 232 engages with the catheter section 332 of the die 300. In one embodiment, the material 80 may be introduced into the cavity 304 after the catheter body 232 engages with the catheter section 332 of the die 300. For example, the material 80 may be introduced into the cavity 304 through the distal end 306 of the die 300 or through a dedicated lumen that extends through the wall of the die body 302 and communicates with the cavity 304.

[0065] As shown in FIG. 8C, energy (RF energy, thermal energy, etc.) may be applied to the material 80 in the cavity 304 of the die 300 to melt the material 80 and form the catheter tip. The material 80 may conform to the shape of the cavity 304 and around the mandrels 310, 312, 314. Furthermore, the material 80 may be fused to the distal end of the catheter body 232. Thus, the material 80 forms the expansion region 234 of the RICC 202 and is connected to the distal end of the catheter body 232. Furthermore, the junction between the transition section 234 and the catheter body 232 provides a smooth abluminal surface.

[0066] 8C and 8D , once the material 80 has been conformed to the shape of the cavity 304, the material 80 may be allowed to solidify or harden to maintain the shape. The die body 302 and one or more mandrels 310, 312, 314 may then be removed to provide an expansion region 234 connected with the catheter body region 232 and form a continuous abluminal surface. Additionally, a portion of one of the primary lumen 210, secondary lumen 212, or tertiary lumen 214 may be formed to extend through the expansion region 234.

[0067] In one embodiment, the die cavity 304 may define at least a portion of the access site 230, or the access site 302, of the RICC 202. Thus, material 80, which may include a first material, a second material, or a third material, may be injected into the cavity 304 to form both the expansion site 234 and the access site 230, as described herein.

[0068] In one embodiment, the diameter of the distal end 306 of the cavity 304 may be equal to the outer diameter (d1) of the access site 230. Additionally, the outer diameter of the distal end of the primary mandrel 310 may be equal to the inner diameter of the primary lumen 210. Thus, the access site 230 may be coupled to the distal end of the expansion site 234 by gluing, bonding, welding, etc. In one embodiment, the primary mandrel 310 may include a collar portion 316. In one embodiment, the outer diameter of the collar 316 of the primary mandrel 310 may be equal to the outer diameter (d1) of the access site 230.

[0069] Thus, as shown in Figures 8E and 8F, the proximal end of the access site 230 may be inserted into a receptacle 138 formed at the distal end of the expansion site 234 and secured therein using adhesives, bonding, welding, etc., as described herein. As described above, the access site 230 and the expansion site 234 may be formed of the same material and may be integrally formed in a die as a single monolithic part and coupled to the catheter body 232. In one embodiment, the access site 230 and the expansion site 234 may be formed of the same material and may be coupled to one another, e.g., in the receptacle 138, using adhesives, bonding, welding, etc., as described herein. In one embodiment, the access site 230 and the expansion site 234 may be formed of different materials and may be coupled to one another, e.g., in the receptacle 138, using adhesives, bonding, welding, etc., as described herein. In one embodiment, the insertion opening 122 may be formed in a distal portion of the catheter body 232 and may communicate with the primary lumen 210.

[0070] Advantageously, the methods described herein may form one or both of the secondary lumen opening 218 or the tertiary lumen opening 220 in the same step as forming the expansion region 234. This may reduce manufacturing complexity and associated costs by eliminating the need to form (e.g., machining, milling, skiving, cutting, etc.) the secondary lumen opening 218 or the tertiary lumen opening 220 after forming the expansion region 234 or after the chipping process. Additionally, the embodiments described herein illustrate methods of forming one or both of the secondary lumen opening 218 or the tertiary lumen opening 220 equally longitudinally distal from the primary lumen opening 216 and within the tapered contour of the expansion region 234 while maintaining smooth abluminal and / or luminal surfaces. Additionally, as shown in Figures 8B and 8C, the die 300, including one or more of the mandrels 310, 312, 314, extends across the junction between the expansion section 234 and the catheter body section 232, thereby providing smooth abluminal and luminal surfaces at the junction between these two structures.

[0071] An exemplary method of using the system 100 including one of the RICC 102 or RICC 202 includes the steps of creating an insertion site, inserting the RICC, and advancing the RICC. The insertion site creation step includes creating an insertion site for accessing the patient's vasculature with an introducer needle 104 disposed within the primary lumen 210 of the RICC 202. The insertion site may be a subclavian vein, such as the right or left subclavian vein, an internal jugular vein, such as the right or left internal jugular vein, or a femoral vein.

[0072] The RICC insertion step includes inserting a distal portion of the RICC 202 into an insertion site past an expansion section 234 disposed between an access site 230 and a catheter body section 232. Optionally, the RICC insertion step is preceded by an access guidewire insertion step followed by a needle withdrawal step. The access guidewire insertion step includes inserting an access guidewire 106 through the distal end of the introducer needle 104 and into one of the aforementioned veins.

[0073] The method further includes a needle withdrawal step, which includes withdrawing the introducer needle 104 from the primary lumen 210 of the RICC 202 after the insertion site preparation step, and inserting at least a portion of a distal portion of the RICC 202 into the insertion site.

[0074] The RICC advancement step includes advancing the distal portion of the RICC 202 within the patient's vasculature without using the Seldinger technique. For example, if the insertion site is in the right subclavian vein or right internal jugular vein, the RICC advancement step may include advancing the distal portion of the RICC 202 through the right subclavian vein, right internal jugular vein, or right brachiocephalic vein into the superior vena cava. Other insertion sites, such as the left subclavian vein or left internal jugular vein, require advancing the distal portion of the RICC 202 through the corresponding vasculature. Optionally, the RICC advancement step is preceded by a steering guidewire insertion step in which a placement guidewire 108 is inserted through the distal end of the RICC 202 to a target location (e.g., the superior vena cava).

[0075] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, it is not intended that the scope of the concept provided herein is limited by the specific embodiments. Additional adaptations and / or modifications may be understood by those skilled in the art. In the broader aspect, 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 concept provided herein.

Claims

1. 1. A method of forming a rapid insertion central venous catheter, the method comprising: providing a catheter body section having a primary lumen, a secondary lumen, and a tertiary lumen each extending longitudinally; placing the distal end of the catheter body section into a die, the die having a first mandrel engaging the primary lumen, a second mandrel engaging the secondary lumen, and a third mandrel engaging the tertiary lumen; and melting a polymeric material disposed within a cavity of the die to form an expansion section coupled to the distal tip of the catheter body section, the expansion section defining a tapered outer contour and including a secondary lumen opening and a tertiary lumen opening, the secondary lumen opening being disposed in a sidewall and communicating with the secondary lumen, and the tertiary lumen opening being disposed in a sidewall and communicating with the tertiary lumen.

2. 10. The method of claim 1, further comprising forming an access site integrally with the dilation site and extending from a distal end of the dilation site, the access site defining a single lumen in communication with a primary lumen, the single lumen extending to a primary lumen opening disposed at a distal tip of the access site.

3. 3. The method of claim 2, wherein the access section and the dilation section are formed of a first polymeric material and the catheter body section is formed of a second polymeric material, the first polymeric material exhibiting a harder durometer than the second polymeric material.

4. The method of claim 1 , wherein the first mandrel includes a collar disposed at a distal end of the first mandrel, the collar defining an outer diameter equal to an outer diameter of an access site.

5. 5. The method of claim 4, further comprising: positioning a proximal end of the access site within a receptacle of the expansion site defined by the collar of the first mandrel; and securing the access site to the expansion site using adhesive, bonding, solvent bonding, or welding.

6. 6. The method of claim 5, wherein the access site is formed of a first polymeric material and the catheter body site is formed of a second polymeric material, the first polymeric material exhibiting a harder durometer than the second polymeric material.

7. 7. The method of claim 6, wherein the expansion portion is formed from one of the first polymeric material, the second polymeric material, and a third polymeric material having a durometer harder than the second polymeric material and softer than the first polymeric material.

8. 8. The method of claim 1, wherein the melting step further comprises applying one of radio frequency (RF) energy or thermal energy to melt the polymer material.

9. 8. The method of claim 1, wherein one or both of the secondary lumen opening and the tertiary lumen opening are located at a longitudinal midpoint between the proximal and distal ends of the expansion region.

10. 8. The method of claim 1, wherein the secondary lumen opening and the tertiary lumen opening are disposed at equal longitudinal lengths from the distal tip of the rapid insertion central venous catheter.

11. 8. The method of claim 1, further comprising forming an introduction opening in communication with the primary lumen, the introduction opening being positioned proximal to one or both of the secondary lumen opening and the tertiary lumen opening, the introduction opening being configured to receive an access needle therethrough, the distal tip of the access needle extending through the primary lumen opening positioned at the distal tip of the rapid insertion central venous catheter.

12. 8. The method of claim 1, wherein the step of providing a catheter body section further comprises extruding or cutting the catheter body section to a predetermined length and connecting a proximal end of the catheter body section to one or more catheter hubs and one or more extension legs.

13. 1. A rapid insertion central venous catheter system comprising a rapid insertion central venous catheter, The rapid insertion central venous catheter comprises: a catheter body defining a primary lumen, a secondary lumen, and a tertiary lumen and including an introduction opening disposed in a sidewall and communicating with the primary lumen; an expansion section extending distally from the catheter body and defining a tapered outer contour, the expansion section defining a secondary lumen opening disposed in a sidewall and communicating with the secondary lumen, and a tertiary lumen opening disposed in a sidewall and communicating with the tertiary lumen; an access site extending from the dilation site, the access site including a primary lumen opening disposed at a distal tip of the access site and in communication with the primary lumen; a needle extending through the introduction opening and a distal portion of the primary lumen, the distal tip of the needle extending through the primary lumen opening. Rapid insertion central venous catheter system.

14. 14. The rapid insertion central venous catheter system of claim 13, wherein the secondary lumen opening and the tertiary lumen opening are disposed at equal longitudinal lengths from the distal tip of the access site.

15. 14. The rapid insertion central venous catheter system of claim 13, wherein the longitudinal length of the access site is less than the longitudinal length of the expansion site.

16. 14. The rapid insertion central venous catheter system of claim 13, wherein the access site is formed of a first material and the catheter body is formed of a second material having a softer durometer than the first material.

17. 17. The rapid insertion central venous catheter system of claim 16, wherein the expansion region is formed from one of the first material, the second material, and a third material having a durometer that is harder than the second material and softer than the first material.

18. 18. The rapid insertion central venous catheter system of claim 13, wherein the expansion section and the access section are integrally formed as a single monolithic piece and fused to the catheter body using RF welding.

19. 18. The rapid insertion central venous catheter system of claim 13, wherein the expansion section is fused to the catheter body using RF welding and defines a receptacle at a distal end, the receptacle having a diameter equal to an outer diameter of the access site, and the proximal end of the access site is coupled to the receptacle using adhesive, bonding, solvent bonding, or welding.

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