Quick insertable central catheter and method thereof

Abstract

Rapidly insertable central catheters ("RICCs") and methods are disclosed. A RICC can include a first section of a first polymeric material in a distal portion of a catheter tube, a second section of a second polymeric material proximal of the first section, and a tapered junction therebetween. The first polymeric material has a first durometer. The second polymeric material has a second, lesser durometer. The junction is formed of the second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer. The first section has a proximal portion disposed in a receptacle of the junction. When the RICC is inserted into an insertion site of a patient, a proximal lumen surface of a distal portion of the junction smoothly transitions onto a proximal lumen surface of the proximal portion of the first section without edges that catch on the skin.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 047,118, filed July 1, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to a rapidly insertable central catheter and a method thereof. Background Technology

[0004] Central venous catheters (CVCs) are formed from materials with relatively low rigidity, resulting in a lack of column strength. Due to this lack of column strength, CVCs are typically inserted into the patient and advanced through their vascular system using the Seldinger technique. The Seldinger technique involves multiple steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the numerous steps are time-consuming, handling of medical devices is difficult, and both can cause patient trauma. Furthermore, the large number of medical devices that need to be interchanged during the multiple steps of the Seldinger technique presents a relatively high risk of contact contamination. Therefore, there is a need to reduce the number of steps and medical devices involved in inserting catheters such as CVCs into patients and advancing them through their vascular system.

[0005] This article discloses a rapidly insertable central catheter (RICC) that includes catheter components and methods for addressing at least the aforementioned problems. Summary of the Invention

[0006] This document discloses a re-internal conduit (RICC) comprising, in some embodiments, a first segment, a second segment, and a tapered junction of a catheter fitting. The first segment of the catheter fitting is formed of a first polymer material having a first hardness. The first segment is located in the distal portion of the catheter fitting. The second segment of the catheter fitting is formed of a second polymer material having a second hardness less than the first hardness. The second segment is located in the distal portion of the catheter fitting proximal to the first segment. The junction of the catheter fitting is formed of the second polymer material, a third polymer material having a third hardness closer to the second hardness than the first hardness, or a combination thereof. The first segment of the catheter fitting has a proximal portion disposed within and securely attached to a receiver in the junction. When the RICC is inserted into the patient's insertion site, the proximal luminal surface of the distal portion of the junction smoothly transitions to the proximal luminal surface of the proximal portion of the first segment without any edges catching on the skin.

[0007] In some embodiments, the edges include solvent-interdiffused polymer materials comprising the first polymer material and the polymer material at the junction.

[0008] In some implementations, the first polymer material is polytetrafluoroethylene, polypropylene, or polyurethane.

[0009] In some implementations, the second polymer material is polyvinyl chloride, polyethylene, polyurethane, or silicone.

[0010] In some implementations, the RICC is a three-lumen catheter having a main lumen, a secondary lumen, and a third lumen. The main lumen has a main lumen orifice in the distal end of a first segment of the catheter fitting. The secondary lumen has a secondary lumen orifice in the side of a second segment of the catheter fitting. The third lumen has a third lumen orifice in the side of the second segment proximal to the secondary lumen orifice.

[0011] In some embodiments, the joint includes a third polymer material that is radio frequency (“RF”) welded to a second section of the conduit fitting. Only the main lumen extends from the second section through the joint and into the first section.

[0012] In some implementations, the RICC has column strength sufficient to prevent buckling of the catheter fitting as it is inserted into the insertion site and advances through the patient's vascular system.

[0013] A method for manufacturing RICC is also disclosed. In some embodiments, the method includes a mandrel insertion step, a first conduit fitting insertion step, a melting step, a pushing step, a first removal step, and a second removal step. The mandrel insertion step includes inserting a stepped mandrel into the main lumen of a second segment of the conduit fitting. The mandrel insertion step forms a conduit with the mandrel mounted. The first conduit fitting insertion step includes inserting the mandrel-mounted conduit fitting into a cavity of an RF welding mold such that the distal end of the mandrel-mounted conduit fitting does not reach the end of the RF welding mold. The melting step includes melting a polymer material, supplementary polymer material, or a combination thereof of the mandrel-mounted conduit fitting within the RF welding mold by heating the RF welding mold. During the melting step, the molten polymer material conforms to the cavity of the RF welding mold, forming a joint welded to the second segment of the conduit fitting. The melting step forms a soft portion of the conduit fitting, which includes the second segment of the conduit fitting and the joint. The pushing step involves pushing the mandrel and the soft portion of the conduit fitting mounted thereon into the end of the RF welding mold as excess molten polymer material flows out through the outlet hole in the end of the mold. The pushing action in the pushing step cuts excess molten polymer material from the distal end of the soft portion of the conduit fitting. The first removal step involves removing the mandrel and the soft portion of the conduit fitting mounted thereon from the RF welding mold. The second removal step involves removing the mandrel from both the main lumen of the second section of the conduit fitting and the receiver of the joint.

[0014] In some embodiments, the method further includes a second catheter insertion step and a coupling step. The second catheter insertion step includes inserting the proximal portion of the rigid part of the catheter fitting into the receiver of the junction. The coupling step includes securing the rigid and soft parts of the catheter fitting together such that when the RICC is inserted into the patient's insertion site, the proximal luminal surface of the distal portion of the junction smoothly transitions to the proximal luminal surface of the proximal portion of the first segment, without any edges snagging on the skin.

[0015] In some embodiments, the method further includes a solvent application step. The solvent application step includes applying solvent to a proximal portion of the rigid part of the catheter fitting, a receiver at the junction, or both. The solvent application step is performed prior to the second catheter fitting insertion step.

[0016] In some embodiments, the method further includes a first conduit fitting obtaining step or a first conduit fitting extrusion step. The first conduit fitting obtaining step or the first conduit fitting extrusion step each include obtaining or extruding a first segment of the conduit fitting. The first segment corresponds to the commensurate portion of the conduit fitting.

[0017] In some embodiments, a first section of the catheter fitting is formed of a first polymer material having a first hardness, a second section of the catheter fitting is formed of a second polymer material having a second hardness less than the first hardness, and the joint of the catheter fitting is formed of the second polymer material, a supplementary polymer material, or a combination thereof, wherein the supplementary polymer material is a third polymer material having a third hardness closer to the second hardness than the first hardness.

[0018] In some embodiments, the method further includes a second catheter fitting acquisition step or a second catheter fitting extrusion step. The second catheter fitting acquisition step or the second catheter fitting extrusion step each include acquiring or extruding a second segment of the catheter fitting. The second segment of the catheter fitting is multi-lumen, having one or more additional lumens leading to the main lumen.

[0019] In some embodiments, the method further includes a polymer rod insertion step. The polymer rod insertion step involves inserting one or more polymer rods into one or more additional cavities prior to the melting step. The one or more polymer rods provide supplemental polymer material.

[0020] In some embodiments, the method further includes a sacrificial tube arrangement step. The sacrificial tube arrangement step includes arranging a sacrificial polymer tube on a stepped mandrel before or after forming the conduit fitting with the mandrel mounted thereon. The sacrificial polymer tube provides supplementary polymer material.

[0021] This document also discloses a method for using a RICC assembly, which in some embodiments includes an insertion site generation step, an RICC insertion step, and an RICC advancement step. The insertion site generation step includes creating an insertion site for access to the patient's vascular system using a guide needle disposed within the main lumen of the RICC. The RICC insertion step includes inserting a distal portion of the RICC catheter fitting through a tapered junction between a first segment and a second segment of the catheter fitting into the insertion site, without snagging on the patient's skin or the edge between the first segment and the junction during RICC insertion. The RICC advancement step includes advancing the distal portion of the catheter fitting through the patient's vascular system without using the Seldinger technique.

[0022] In some embodiments, the method further includes a needle withdrawal step of withdrawing the guide needle from the main lumen of the RICC after the insertion site generation step and insertion of at least some distal portions of the catheter fitting into the insertion site.

[0023] In some implementations, the insertion site is located in the right subclavian vein or the right internal jugular vein.

[0024] In some implementations, the RICC advancement step includes advancing the distal portion of the catheter fitting through the right subclavian vein or right internal jugular vein, right brachiocephalic vein, and into the superior vena cava.

[0025] These and other features of the concepts provided herein will become more readily understood by those skilled in the art, taking into account the accompanying drawings which describe specific embodiments of these concepts in more detail and the following description. Attached Figure Description

[0026] Figure 1 The RICC components according to some implementation schemes are shown.

[0027] Figure 2 The following are illustrated according to some implementation schemes. Figure 1 The distal portion of the RICC conduit fitting.

[0028] Figure 3 The following are illustrated according to some implementation schemes. Figure 2 The first cross-section of the conduit fitting.

[0029] Figure 4 The following are illustrated according to some implementation schemes. Figure 2 The second cross section of the conduit fitting.

[0030] Figure 5 The following are illustrated according to some implementation schemes. Figure 2 The third cross section of the conduit fitting.

[0031] Figure 6 The following are illustrated according to some implementation schemes. Figure 2 The fourth cross section of the conduit fitting.

[0032] Figure 7A Manufacturing according to some implementation schemes is shown Figure 1 The polymer rod insertion step in the first method of RICC.

[0033] Figure 7B Manufacturing according to some implementation schemes is shown Figure 1 The mandrel insertion step in the first method of RICC.

[0034] Figure 7C Manufacturing according to some implementation schemes is shown Figure 1 The melting step and the pushing step in the first method of RICC.

[0035] Figure 8A Manufacturing according to some implementation schemes is shown Figure 1 The sacrificial tube-disposing step in the second method of RICC.

[0036] Figure 8B Manufacturing according to some implementation schemes is shown Figure 1 The mandrel insertion step in the second method of RICC.

[0037] Figure 8C Manufacturing according to some implementation schemes is shown Figure 1 The melting step and the pushing step in the second method of RICC.

[0038] Figure 9 Manufacturing according to some implementation schemes is shown Figure 1 Detailed views of the melting and pushing steps in the first or second method of RICC.

[0039] Figure 10 The second conduit fitting insertion step and the connection step are shown in a method according to some embodiments. Detailed Implementation

[0040] 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 provided herein. It should also be understood that features of the specific embodiments disclosed herein can be readily separated from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0041] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that they do 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 within a set of features or steps, and do not provide for a series or numerical limitation. For example, the features or steps “first,” “second,” and “third” need not appear in sequence, and a particular embodiment including these features or steps is not limited to these three features or steps. For convenience, terms such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used, and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative positions, orientations, or directions. Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include plural references.

[0042] Regarding "proximal," for example, the "proximal" or "proximal portion" or "proximal portion" of a catheter disclosed herein includes the portion of the catheter intended to be close to the clinician when the catheter is used with the patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used with the patient. For example, the "proximal end" of a catheter includes the tip of the catheter intended to be close to the clinician when the catheter is used with the patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter may not necessarily include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0043] Regarding "distal," for example, the "distal" or "distal portion" or "distal part" of a catheter disclosed herein includes the portion of the catheter intended to be close to or within the patient when the catheter is used in the patient. Similarly, the "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when the catheter is used in the patient. For example, the "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when the catheter is used in the patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter may not necessarily include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0044] 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.

[0045] As mentioned above, there is a need to reduce the number of steps and medical devices involved in inserting a catheter into a patient and advancing it through their vascular system. This article discloses a RICC and its method for addressing the above needs.

[0046] In addition to the need for such RICCs and their methods, certain human factors need to be overcome during the manufacture of RICCs. For example, an RICC may be multi-lumen, but the transition from its distal portion to a single-lumen portion is quite difficult to manufacture without creating edges or bulges that hook onto the patient's skin around the insertion site and prevent RICC insertion. Therefore, this paper also discloses RICCs and their methods that address the aforementioned needs.

[0047] Quick-insertion central catheter

[0048] Figure 1 The RICC components according to some implementation schemes are shown.

[0049] As shown in the figure, the RICC assembly 100 includes an RICC 102, a guide needle 104, an entry guidewire 106, and a manipulating guidewire 108 connected together in the ready-to-deploy state of the RICC assembly 100. Each of the aforementioned components of the RICC assembly 100 is described sequentially in the sections described below; however, due to the interrelationships in the RICC assembly 100, there are some overlaps between the sections for the RICC 102, guide needle 104, entry guidewire 106, and manipulating guidewire 108.

[0050] RICC 102 can be a single-lumen or multi-lumen RICC (e.g., double-lumen RICC, triple-lumen RICC, quadruple-lumen RICC, pentalumen RICC, hexalumen RICC, etc.). In fact, Figure 1 The RICC 102 shown is a three-lumen system comprising a group of three lumens. Such a group of three lumens includes a main lumen 110 (e.g., distal lumen), a secondary lumen 112 (e.g., intermediate lumen), and a third lumen 114 (e.g., proximal lumen), formed by fluid connections of three catheter lumens, three bushing lumens, and three extension leg lumens.

[0051] (see Figure 2 and Figure 3-6 )

[0052] Whether RICC 102 is single-lumen or multi-lumen, RICC 102 includes at least a main lumen 110. The main lumen 110 typically extends from the proximal end of RICC 102 to the distal end of RICC 102, for example, from the opening of a corresponding Luer connector to a main lumen aperture 116 at the distal end of catheter fitting 124 (e.g., the rigid portion of catheter fitting 124 or a first segment of catheter fitting 124), as described below. When RICC 102 has two or more lumens, RICC 102 also includes at least a secondary lumen 112. The secondary lumen 112 typically extends from the proximal end of RICC 102 to the distal portion of RICC 102, for example, from the opening of a corresponding Luer connector to a secondary lumen aperture 118 proximal to the main lumen aperture 116 in the distal portion of catheter fitting 124 (e.g., the soft portion of catheter fitting 124 or a second segment of catheter fitting 124). When RICC 102 has three or more lumens, RICC 102 also includes at least a third lumen 114. The third lumen 114 typically extends from the proximal end of RICC 102 to a distal portion of RICC 102, for example, from the opening of the corresponding Luer connector to a distal portion of catheter fitting 124 (e.g., the soft portion of catheter fitting 124 or a first segment of catheter fitting 124) in a third lumen aperture 120 proximal to the secondary lumen aperture 118. Nevertheless, considering different manufacturing methods, each lumen of the secondary lumen 112 and the third lumen 114 may extend distally slightly beyond the secondary lumen aperture 118 and the third lumen aperture 120, respectively. (See...) Figure 2 , Figure 5 and Figure 6 )

[0053] RICC 102 is shown with a guide hole 122 dedicated to receiving a guide needle 104 through which to connect RICC 102 and guide needle 104 together in RICC assembly 100. However, RICC 102 does not necessarily include a dedicated guide hole, such as guide hole 122. In practice, in some embodiments, a secondary lumen hole 118 or a third lumen hole 120 can be used as guide hole 122, requiring different modes of connection of RICC 102 and guide needle 104 as described below. Alternatively, for example, when RICC 102 is a single lumen, a guide hole can be formed as needed by puncturing catheter fitting 124 with guide needle 104.

[0054] RICC 102 further includes a guide lumen that coincides with the distal portion of the main lumen 110. In other words, the guide lumen is the guide portion of the main lumen 110 of RICC 102. In RICC 102, the guide lumen is the distal portion of the main lumen 110 extending from the guide port 122 to the main lumen port 116. The guide port 122 opens directly to the proximal end of the guide portion of the main lumen 110 of RICC 102, and this guide port 122 may be distal to the secondary lumen port 118, between the secondary lumen port 118 and the third lumen port 120, or proximal to the third lumen port 120. For RICCs without a guide port 122, the guide lumen is the distal portion of the main lumen 110 extending from the secondary lumen port 118, the third lumen port 120, or a puncture port created by the guide needle 104 to the main lumen port 116. Whether the guiding lumen extends from the secondary lumen 118, the third lumen 120, or the puncture port depends on which of the aforementioned holes accommodates the guide needle 104. Neither the secondary lumen 118 nor the third lumen 120 opens directly to the proximal end of the guiding portion of the main lumen 110 of the RICC, which lacks a guide port 122. Instead, the guide needle 104 punctures the septum 123 between the secondary lumen 112 or the third lumen 114 and the main lumen 110 through the secondary lumen 118 or the third lumen 120, respectively.

[0055] RICC 102 includes a catheter fitting 124, a catheter bushing 126, and one or more extension legs 128.

[0056] Figure 2 The following are illustrated according to some implementation schemes. Figure 1 The distal portion of the conduit fitting 124 of RICC 102. Figure 3-6 The following are illustrated according to some implementation schemes. Figure 2 Multiple cross sections of the conduit fitting 124.

[0057] The catheter fitting 124 includes a rigid portion and a soft portion, wherein "rigid" and "soft" are used in a relative sense, because the rigid portion of the catheter fitting 124 is harder than the soft portion. Similarly, the soft portion of the catheter fitting 124 is softer than the rigid portion. The rigid portion of the catheter fitting 124 includes a first segment 130 in the distal portion of the catheter fitting 124, while the soft portion includes a second segment 132 extending from the proximal portion of the catheter fitting 124 to its distal portion but proximal to the first segment 130. Although the tapered joint 134 of the catheter fitting 124 in RICC 102 includes the proximal portion of the rigid portion of the catheter fitting 124, the soft portion of the catheter fitting 124 is generally considered to include the joint 134 based on its construction. The arrangement of the first section 130, the second section 132, and the junction 134 of the catheter fitting 124 simultaneously has column strength sufficient to prevent buckling of the catheter fitting 124 when it is inserted into an insertion site established by percutaneous puncture and advanced through the patient's vascular system.

[0058] Each of the first section 130, the second section 132, and the joint 134 of the conduit fitting 124 is described in more detail below.

[0059] Similar to RICC 102 described above, catheter fitting 124 can be single-lumen or multi-lumen. In practice, catheter fitting 124 includes one or more catheter lumens corresponding in name and number to those in RICC 102. One or more catheter lumens extend through catheter fitting 124, as described above for RICC 102.

[0060] Similar to the RICC 102 described above, the catheter fitting 124 is shown with a guide hole 122 extending through its distal portion. Similarly, the guide hole 122 is dedicated to receiving a guide needle 104 through which it passes, for joining the RICC 102 and the guide needle 104 together in the RICC assembly 100. However, neither the RICC 102 nor the catheter fitting 124 needs to include a dedicated guide hole. In fact, excluding the guide hole 122, the catheter fitting can include n-1 side holes extending through its sides, depending on the number of lumens n of the RICC. In embodiments of the RICC without a dedicated guide hole, any one of the n-1 side holes can serve as the guide hole 122. Considering a RICC with three lumens like the RICC 102 described above, the catheter fitting for such a RICC includes two side holes, such as the secondary lumen hole 118 and the third lumen hole 120 described above. In addition to providing different holes for aspirating blood, delivering fluids, etc., any of these side holes can be used as guide holes 122 for connecting the RICC and guide needle 104 together in the respective RICC assembly.

[0061] A first segment 130 of the catheter fitting 124 is located in the distal portion of the catheter fitting 124. The first segment 130 includes a distal end 136 with a relatively short taper that extends from the angled end 146 of the guide needle 104 in the RICC assembly 100 to the outer diameter of the remainder of the first segment 130. The taper of the distal end 136 is configured to immediately expand tissue around the percutaneous puncture established with the guide needle 104 until the outer diameter of the remainder of the first segment 130 of the catheter fitting 124 is reached. The first segment 130 also includes a proximal portion disposed within and fixedly coupled (e.g., solvent-bonded, adhered, welded, etc.) to the receiver 138 of the junction 134.

[0062] The first section 130 of the catheter fitting 124 is formed of a first polymer material having a first rigidity. The first polymer material may be polytetrafluoroethylene, polypropylene, or polyurethane, but is not limited to the aforementioned polymers. Polyurethane is advantageous because the first section 130 of the catheter fitting 124 can be relatively rigid at room temperature, but becomes more flexible in the body at body temperature, which reduces phlebitis and irritation to the blood vessel walls.

[0063] A second section 132 of the catheter fitting 124 extends from the proximal portion of the catheter fitting 124 to its distal portion, but is close to the first section 130 of the catheter fitting 124. The second section 132 includes a distal end and a proximal end, the distal end being integrally formed with the proximal end of the junction 134 (e.g., RF welding), and the proximal end being disposed in and fixedly coupled to the catheter bushing 126 (e.g., solvent bonding, welding, adhesion, etc.).

[0064] The second section 132 of the catheter fitting 124 is formed of a second polymer material having a second hardness less than that of the first hardness. The second polymer material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the aforementioned polymers. Polyurethane is advantageous in addition to the polyurethane described above in the first section 130 of the catheter fitting 124 because it is less prone to thrombosis than some other polymers.

[0065] The junction 134 of the catheter fitting 124 connects the first section 130 and the second section 132 of the catheter fitting 124 together. The junction 134 includes a receiver 138 in its distal portion (see...). Figure 10 The distal portion includes the proximal portion of the first segment 130 of the catheter fitting 124, which is disposed therein and securely joined (e.g., solvent-bonded, welded, adhered, etc.) to it. The proximal end of the junction 134 is integral with the distal end of the second segment 132 of the catheter fitting 124 (e.g., by RF welding), effectively terminating the passage of the lumen of the second segment 132 of the catheter fitting 124 through the junction 134, except for the main lumen 110. The junction 134 also includes a taper along its length from distal to proximal, configured to immediately expand the tissue surrounding the percutaneous puncture to the outer diameter of the second segment 132 of the catheter fitting 124. When the RICC 102 is inserted into the patient's insertion site, the proximal luminal surface of the junction 134 smoothly transitions from the proximal luminal surface of the proximal portion of the first segment 130 without hooking the edge 140 onto the skin. Except for the edge 140 being minimal to negligible, the edge 140 may include a polymer material in which the solvent of the first polymer material and the polymer material of the joint 134 diffuses into each other, which makes the transition from the first segment 130 of the conduit fitting 124 to the joint 134 smooth.

[0066] The joint 134 of the conduit fitting 124 is formed of a second polymer material or a third polymer material having a hardness closer to the second hardness than the first hardness. Similarly, the second polymer material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the aforementioned polymers.

[0067] Similarly, the first section 130 of the conduit fitting 124 is formed of a first polymeric material having a first hardness, the second section 132 of the conduit fitting 124 is formed of a second polymeric material having a second hardness less than the first hardness, and the joint 134 of the conduit fitting 124 is formed of either a second polymeric material or a third polymeric material having a third hardness closer to the second hardness than the first hardness. Both the second and third hardnesses are less than the first hardness, and the soft portion of the conduit fitting 124 including the second section and the joint 134 is softer than the hard portion of the conduit fitting 124 including the first section. In other words, the first hardness is greater than each of the second and third hardnesses.

[0068] It should be understood that the first hardness of the first polymer material, the second hardness of the second polymer material, and the third hardness of the third polymer material can be on different scales (e.g., type A or type D), so the second hardness or the third hardness may not be numerically less than the first hardness. In other words, considering different scales, the material with the first hardness may not be numerically greater than the second or third hardness. That is to say, the hardness of the second or third polymer material can still be less than the hardness of the first polymer material, or the hardness of the first polymer material can still be greater than the hardness of the second or third polymer material, because different scales (each scale ranging from 0 to 100) are designed to characterize different materials in a group of materials with the same hardness.

[0069] Nevertheless, the first section 130, the second section 132, and the junction 134 of the catheter fitting 124 may be formed of the same polymeric material or different polymeric materials having substantially equal hardness, provided that the column strength of the catheter fitting 124 is sufficient to prevent buckling of the catheter fitting 124 when it is inserted into the insertion site established by percutaneous puncture and advanced through the patient's vascular system.

[0070] The catheter bushing 126 is coupled to the proximal portion of the catheter fitting 124. The catheter bushing 126 includes one or more catheter bushing lumens corresponding in number to one or more catheter lumens. The one or more catheter bushing lumens extend from the proximal end of the catheter bushing 126 through the entire catheter bushing 126 to the distal end of the catheter bushing 126.

[0071] Each of the one or more extension legs 128 is coupled to the catheter bushing 126 via a distal portion of the extension leg. The one or more extension legs 128 correspondingly include one or more extension leg lumens, which in turn correspond in number to one or more catheter fitting lumens. Each of the one or more extension leg lumens extends from the proximal end of the extension leg through the entire extension leg to the distal end of the extension leg.

[0072] Each of the one or more extension legs 128 typically includes a Luer connector attached to the extension leg, and the extension leg and its interior can be connected to another medical device via the Luer connector.

[0073] The guide needle 104 includes a rod 142, a needle bushing 144 surrounding a proximal portion of the rod 142, and an angled end 146 in a distal portion of the rod 142.

[0074] When the RICC assembly 100 is in the deployment-ready state, the guide needle 104 or its rod 142 is positioned within the guide lumen through the guide port 122 (if present), or through the secondary lumen port 118 or the third lumen port 120 (if the guide port is absent), or by using the guide needle 104 to create a puncture, such that the inclined end 146 of the guide needle 104 extends beyond the distal end of the first segment 130 of the catheter fitting 124 to establish a percutaneous puncture. When the guide needle 104 or its rod 142 is positioned within the guide lumen through the secondary lumen port 118 or the third lumen port 120, the guide needle 104 or its rod 142 is also positioned to pass through the diaphragm 123 that separates the secondary lumen 112 or the third lumen 114 from the main lumen 110.

[0075] The guidewire 106 includes a length sufficient for advancement, i.e., a distance sufficient to establish access to the vascular lumen, to advance the distal portion of the RICC 102 into the vascular lumen, thereby maintaining access.

[0076] When the RICC assembly 100 is at least in the ready-to-deploy state, the access guidewire 106 is positioned within the needle lumen of the guide needle 104. In practice, the distal end of the access guidewire 106 is close to the angled end 146 of the guide needle 104, but distal to the junction 134. This allows the distal end of the access guidewire 106 to immediately advance beyond the angled end 146 of the guide needle 104 and into the blood lumen upon establishing access to the access guidewire 106.

[0077] The guidewire 106 includes a stop 148 (e.g., bushing, ball, bump, etc.) surrounding the proximal portion of the guidewire 106, which forms a blocking end (e.g., bushing end, ball end, bump end, etc.) of the guidewire 106. The blocking end of the guidewire 106 is larger than any orifice of the RICC 102 or its catheter fitting 124, thereby providing a distal limit for advancing the guidewire 106 into the RICC 102.

[0078] The manipulator 108 includes a trauma-resistant tip (e.g., a coiled or partially coiled tip) and a length sufficient to advance the manipulator 108 into the lower third of the superior vena cava (“SVC”) of the heart.

[0079] When the RICC assembly 100 is at least in the ready-to-deploy state, the manipulating guidewire 108 is positioned within the main lumen 110 of the RICC 102 such that the distal end of the manipulating guidewire 108 is close to the guide port 122 but distal to the catheter bushing 126. This allows the distal end of the manipulating guidewire 108 to be immediately advanced into the blood lumen when the guide needle 104 or its rod 142 is removed from the guide lumen. In practice, because the guide needle 104 or its rod 142 is present in the at least ready-to-deploy state of the RICC assembly 100, the manipulating guidewire 108 cannot be advanced distally into the guide lumen.

[0080] The control wire 108 includes a stop 150 (e.g., bushing, ball, bump, etc.) surrounding a proximal portion of the control wire 108, the stop 150 forming a stopping end (e.g., bushing end, ball end, bump end, etc.) of the control wire 108. The stopping end of the control wire 108 is larger than the proximal opening in the Luer connector of the extension leg, in which the control wire 108 is disposed, thereby providing for advancing the control wire 108 to the distal limit in the RICC 102.

[0081] method

[0082] The method of RICC component 100 includes a method of manufacturing RICC component 100 and a method of using RICC component 100. Figures 7A-7C , Figure 9 and Figure 10 The various steps of a first method for manufacturing RICC 102 of RICC component 100 according to some embodiments are shown. Figures 8A-8C , Figure 9 and Figure 10 The steps of a second method for manufacturing RICC 102 of RICC component 100 according to some embodiments are shown. After describing the first and second methods for manufacturing RICC 102, a method for using RICC component 100 is described.

[0083] The first and second methods for manufacturing RICC 102 are similar in that each method includes a mandrel insertion step, a first conduit fitting insertion step, a melting step, a pushing step, a first removal step, and a second removal step. The primary difference between the first and second methods is the addition of supplementary polymer material to the joint 134. Indeed, the first method includes adding supplementary polymer material as one or more polymer rods 152, while the second method includes adding supplementary polymer material as a sacrificial polymer tube 154. That is, the method for manufacturing RICC 102 need not include adding supplementary polymer material according to the first or second method, because at least an excess distal portion of the second segment 132 of the conduit fitting 124 can be used as supplementary polymer material when manufacturing RICC assembly 100. When manufacturing RICC assembly 100, the excess distal portion of the second segment 132 is the portion in RICC 102 that exceeds the second segment 132 of the conduit fitting 124. This is how the joint 134 is formed. The step of adding supplementary polymer material according to the first and second methods has been described initially, followed by steps common to both methods, which are described sequentially in the following sections.

[0084] Despite the above description, regardless of whether the first or second method for manufacturing RICC 102 is implemented, each of the first and second methods includes a second conduit fitting obtaining step or a second conduit fitting forming step, which is designated as the second segment 132 corresponding to conduit fitting 124. The second conduit fitting obtaining step or the second conduit fitting forming step respectively includes obtaining or forming the second segment 132 of conduit fitting 124 of a second polymeric material having a second hardness. The second conduit fitting forming step includes forming the second segment 132 of conduit fitting 124, for example, by extruding the second segment 132, cutting the second segment 132 to an appropriate length, etc. The second segment 132 of conduit fitting 124 may be single-lumen or multi-lumen (having one or more additional lumens besides the main lumen 110).

[0085] As shown in Figure 7A, a first method for preparing the RICC 102 includes a polymer rod insertion step. The polymer rod insertion step involves inserting one or more polymer rods 152 (e.g., ≤ about 1 / 2″ of each of the one or more polymer rods 152) into one or more additional lumens of a second segment 132 of the conduit fitting 124. The one or more polymer rods 152 provide supplemental polymer material to the junction 134, which may be the second or third polymer material described above. The one or more additional lumens are those other than the main lumen 110 in a multi-lumen RICC. Such one or more additional lumens include, for example, a secondary lumen 112 or a third lumen 114. The polymer rod insertion step can be performed before or after the mandrel insertion step, but it is easiest to perform it before the mandrel insertion step based on the smaller diameter of each lumen of the one or more additional lumens compared to the larger diameter of the main lumen 110. In practice, it may be more difficult to locate the one or more additional lumens when the stepped mandrel 156 is already arranged in the main lumen 110 and may block the one or more additional lumens.

[0086] like Figure 8A As shown, the second method for preparing RICC 102 includes a sacrificial tube arrangement step. The sacrificial tube arrangement step includes arranging a sacrificial polymer tube 154 (e.g., about 1 / 2″ of the sacrificial polymer tube 154) on the mandrel 156. The sacrificial polymer tube 154 provides supplemental polymer material to the joint 134, which may be the second or third polymer material described above. The sacrificial tube arrangement step can be performed before or after the mandrel insertion step, but based on the larger diameter of the stepped portion of the mandrel 156 compared to the smaller diameter of the body of the mandrel 156, the sacrificial tube arrangement step is most likely to be performed before the mandrel insertion step. In fact, considering the tighter tolerances between the sacrificial polymer tube 154 and the stepped portion of the mandrel 156, it may be more difficult to arrange the sacrificial polymer tube 154 directly on the larger diameter stepped portion of the mandrel 156 than on the smaller diameter body of the mandrel 156. Although the sacrificial polymer tube 154 is shown as being on the body of the mandrel 156, it should be understood that the sacrificial polymer tube 154 can be arranged on the stepped portion of the mandrel 156. As described above, it may be more difficult to do so directly.

[0087] Advantageously, the second method of manufacturing RICC 102 is useful for single-lumen RICCs that do not include one or more additional lumens leading to the main lumen 110. Indeed, if the first method of manufacturing RICC 102 and its polymer rod insertion step are used for a single-lumen RICC, one or more polymer rods 152 will utilize supplemental polymer material in RICC 102 to block one and only main lumen 110.

[0088] Whether the first method or the second method for manufacturing RICC 102 is implemented, each of the first and second methods includes the above-described mandrel insertion step, first conduit insertion step, melting step, pushing step, first removal step, and second removal step.

[0089] like Figure 7B and 8B As shown, the mandrel insertion step includes inserting mandrel 156 into the main lumen 110 of the second segment 132 of catheter fitting 124 to form a catheter fitting 158 with the mandrel mounted. Although the stepped portion of mandrel 156 is shown at a distance from the distal end of the second segment 132 of catheter fitting 124, it should be understood that the stepped portion of mandrel 156 can be adjacent to the distal end of the second segment 132. In practice, it is preferable to insert mandrel 156 into the main lumen 110 of the second segment 132 of catheter fitting 124 such that the stepped portion of mandrel 156 is as close as possible to the distal end of the second segment 132. Figure 7B As shown, the conduit fitting 158 mounted on the mandrel also includes one or more polymer rods 152 disposed in one or more additional lumens. Figure 8B As shown, the conduit fitting 158 with the mandrel mounted also includes a sacrificial polymer tube 154 disposed on the mandrel 156.

[0090] like Figure 7C and 8C As shown, the first conduit fitting insertion step includes inserting the conduit fitting 158 with a mandrel mounted into the cavity of the RF welding mold 160, such that the distal end of the conduit fitting 158 with the mandrel mounted does not reach the end of the RF welding mold 160.

[0091] like Figure 7C and 8C as well as Figure 9 As shown, the melting step includes melting a polymer material, supplementary polymer material, or a combination thereof, of the conduit fitting 158 with a mandrel mounted in the RF welding mold 160 by heating the RF welding mold 160. During the melting step, the molten polymer material conforms to the cavity of the RF welding mold 160, forming a joint 134 welded to the second segment 132 of the conduit fitting 124. The melting step forms a soft portion of the conduit fitting 124, which includes the second segment 132 of the conduit fitting 124 and the joint 134.

[0092] like Figure 9As shown, the pushing step includes pushing the mandrel and the soft portion of the conduit fitting mounted thereon into the end of the RF welding mold 160 as excess molten polymer material flows out through the outlet hole 162 in the end of the RF welding mold 160. Through the pushing action in the pushing step, excess molten polymer material is cut from the distal end of the soft portion of the conduit fitting 124.

[0093] The first removal step includes removing the mandrel 156 and the soft portion of the conduit fitting 124 mounted thereon from the RF welding mold 160.

[0094] The second removal step includes removing the mandrel 156 from both the main lumen 110 of the second section 132 of the conduit fitting 124 and the receiver 138 of the junction 134.

[0095] Regardless of whether the first method or the second method for manufacturing RICC 102 is implemented, each of the first and second methods includes a first conduit / tube part obtaining step or a first conduit / tube part extrusion step, which is designated as a first segment 130 corresponding to conduit / tube part 124. The first conduit / tube part obtaining step or the first conduit / tube part forming step respectively includes obtaining or forming the first segment 130 of conduit / tube part 124 of a first polymeric material having a first hardness. The first conduit / tube part forming step includes forming the first segment 130 of conduit / tube part 124, for example, by extruding the first segment 130, cutting the first segment 130 to an appropriate length, etc. The first segment 130 corresponds to the hard portion of conduit / tube part 124.

[0096] Whether the first method or the second method for manufacturing RICC 102 is implemented, each of the first and second methods may further include an application step, a second conduit insertion step, a connection step, and a hole generation step.

[0097] The application step includes a solvent application step of applying a solvent, or an adhesive application step of applying adhesive to the proximal portion of the rigid portion of the catheter fitting 124, the receiver 138 of the joint 134 of the soft portion of the catheter fitting 124, or both. The application step is performed before the second catheter fitting insertion step.

[0098] like Figure 10As shown, the second catheter insertion step involves inserting the proximal portion of the rigid part of the catheter fitting 124 (i.e., the first segment 130 of the catheter fitting 124) into the receiver 138 of the junction 134. Specifically, the inner diameter of the first segment 130 of the catheter fitting 124 and the inner diameter of the portion of the first lumen 110 within the junction 134 are matched after the second catheter insertion step. This eliminates the difficulty of the guidewire getting caught between the lumen surface of the first segment 130 of the catheter fitting and the junction 134.

[0099] The joining step includes allowing solvent evaporation after the second catheter fitting insertion step, thereby forming a solvent-bonded joint between the first segment 130 of the catheter fitting 124 and the junction 134, having a polymer material in which the solvents of the first polymer material and the polymer material of the junction 134 diffuse into each other. If an adhesive is used, the joining step includes allowing the adhesive to dry (i.e., allowing its solvent to evaporate) after the insertion step, thereby forming an adhesive-bonded joint between the first segment 130 of the catheter fitting 124 and the junction 134, which optionally also has an adhesive, a polymer material in which the polymer material of the junction 134 and the solvents of the first polymer material diffuse into each other. Thus, the joining step securely joins the rigid and soft portions of the catheter fitting 124 together such that when the RICC 102 is inserted into the patient's insertion site, the proximal luminal surface of the distal portion of the junction 134 smoothly transitions over the edge 140 to the proximal luminal surface of the proximal portion of the first segment 130 without snagging on the skin.

[0100] like Figure 10 As shown, the orifice-forming step includes creating one or more orifices, such as a secondary lumen orifice 118 or a third lumen orifice 120, in the distal portion of the catheter fitting 124 for each of the one or more additional lumens. The orifice-forming step may include a orifice-puncture step, wherein the orifice-puncture step involves puncturing the catheter fitting 124 to form one or more orifices, and the orifice-melting step involves melting the catheter fitting 124 to form one or more orifices.

[0101] In view of the above-described method for manufacturing RICC 102, the first section 130 of the conduit fitting 124 is formed of a first polymeric material having a first hardness, the second section 132 of the conduit fitting 124 is formed of a second polymeric material having a second hardness less than the first hardness, and the joint 134 of the conduit fitting 124 is formed of a second polymeric material, a supplementary polymeric material, or a combination thereof, wherein the supplementary polymeric material is a third polymeric material having a third hardness closer to the second hardness than the first hardness.

[0102] The method of using RICC component 100 or RICC 102 includes an insertion site generation step, an RICC insertion step, and an RICC advancement step.

[0103] The insertion site creation step includes creating an insertion site by using a guide needle 104 positioned within the main lumen 110 of the RICC 102 to enter the patient's vascular system. The insertion site can be in the subclavian vein (e.g., the right or left subclavian vein), the internal jugular vein (e.g., the right or left internal jugular vein), or the femoral vein.

[0104] The RICC insertion step involves inserting the distal portion of the catheter fitting 124 of the RICC 102 into the insertion site, up to the junction 134 between the first segment 130 and the second segment 132 of the catheter fitting 124, without the edge 140 between the first segment 130 and the junction 134 catching on the patient's skin during the RICC insertion step. Optionally, the RICC insertion step begins with an entry guidewire insertion step and a subsequent needle withdrawal step. The entry guidewire insertion step involves inserting an entry guidewire 106 through the distal end of the guidewire 104 and into one of the aforementioned veins.

[0105] The method further includes a needle withdrawal step. The needle withdrawal step includes withdrawing the guide needle 104 from the main lumen 110 of the RICC 102 after the insertion site creation step and insertion of at least some distal portions of the catheter fitting 124 into the insertion site.

[0106] The RICC advancement step involves advancing the distal portion of catheter fitting 124 through the patient's vascular system 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 catheter fitting 124 through the right subclavian vein or right internal jugular vein, right brachiocephalic vein, and into the superior vena cava. Advancing the distal portion of catheter fitting 124 through the corresponding vascular system may also be required at other insertion sites, such as the left subclavian vein or left internal jugular vein. Optionally, the RICC advancement step may begin with a manipulator guidewire insertion step, which inserts manipulator guidewire 108 through the distal end of RICC 102 and to the target location (e.g., superior vena cava).

[0107] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A central catheter that can be quickly inserted, characterized in that, include: A first section of the catheter fitting, formed of a first polymer material having a first hardness, is located in the distal portion of the catheter fitting. The second section of the catheter fitting is formed of a second polymer material having a second hardness less than the first hardness, and the second section is located in the distal portion of the catheter fitting proximal to the first section. and The conical joint of the catheter fitting is formed of a second polymer material, a third polymer material, or a combination thereof, wherein the third polymer material has a third hardness that is closer to the second hardness than the first hardness. A first segment of the catheter fitting has a receiver disposed in the joint and fixedly coupled to a proximal portion of the receiver, such that when the rapidly insertable central catheter is inserted into the patient's insertion site, the proximal luminal surface of the distal portion of the joint smoothly transitions to the proximal luminal surface of the proximal portion of the first segment, without the edge between the first segment and the joint hooking onto the skin. The receiver, which fixes the proximal portion of the first section of the conduit fitting to the junction via solvent bonding, has an edge comprising a polymer material in which the solvents of the first polymer material and the polymer material of the junction diffuse into each other.

2. The rapidly insertable central catheter according to claim 1, characterized in that, The first polymer material is polytetrafluoroethylene, polypropylene, or polyurethane.

3. The rapidly insertable central catheter according to claim 1, characterized in that, The second polymer material is polyvinyl chloride, polyethylene, polyurethane, or silicone.

4. The rapidly insertable central catheter according to claim 1, characterized in that, The rapidly insertable central catheter is a three-lumen catheter, which has a main lumen, a secondary lumen, and a third lumen. The main lumen has a main lumen orifice at the distal end of the first section of the catheter fitting. The secondary lumen has a secondary lumen orifice on the side of the second section of the catheter fitting. The third lumen has a third lumen orifice on the side of the second section proximal to the secondary lumen orifice.

5. The rapidly insertable central catheter according to claim 4, characterized in that, The joint includes the third polymer material radiofrequency welded to the second section of the catheter fitting, with only the main lumen extending from the second section through the joint and into the first section.

6. The rapidly insertable central catheter according to claim 1, characterized in that, The rapidly insertable central catheter has column strength sufficient to prevent buckling of the catheter fitting when it is inserted into the insertion site and advanced through the patient's vascular system.

7. A method for manufacturing a rapidly insertable central catheter, characterized in that, include: The stepped mandrel is inserted into the main inner cavity of the second section of the conduit fitting, thereby forming a conduit fitting with the mandrel installed. The conduit fitting with the mandrel installed is inserted into the cavity of the radio frequency welding mold, such that the distal end of the conduit fitting with the mandrel installed does not reach the end of the radio frequency welding mold. By heating the radio frequency welding mold, the polymer material, supplementary polymer material, or combination thereof of the conduit fitting with the mandrel mounted is melted in the radio frequency welding mold. The molten polymer material conforms to the cavity of the radio frequency welding mold during melting to form a joint welded to a second section of the conduit fitting, and thus forms the soft portion of the conduit fitting. When excess molten polymer material flows out through the outlet hole in the end of the RF welding mold, the mandrel and the soft portion of the conduit fitting mounted thereon are pushed together into the end of the RF welding mold, and the excess molten polymer material is cut from the distal end of the soft portion of the conduit fitting. Remove the mandrel and the soft portion of the conduit fitting mounted thereon together from the radio frequency welding mold; Remove the mandrel from both the main lumen of the second section of the catheter fitting and the receiver of the joint; Insert the proximal portion of the rigid part of the conduit fitting into the receiver of the joint; and The rigid and flexible portions of the catheter fitting are securely connected together such that when the rapidly insertable central catheter is inserted into the patient's insertion site, the proximal surface of the distal portion of the junction smoothly transitions to the proximal surface of the proximal portion of the rigid portion, without the edge between the rigid portion and the junction getting caught on the skin.

8. The method according to claim 7, characterized in that, The method further includes applying a solvent to the proximal portion of the rigid portion of the catheter fitting, the receiver of the joint, or both, before inserting the proximal portion of the rigid portion of the catheter fitting into the receiver of the joint.

9. The method according to claim 7, characterized in that, It further includes obtaining or extruding a first section of the conduit fitting, the first section being proportional to the rigid portion of the conduit fitting.

10. The method according to claim 9, characterized in that, The first section of the catheter fitting is formed of a first polymer material having a first hardness, the second section of the catheter fitting is formed of a second polymer material having a second hardness, the second hardness being less than the first hardness, and the joint of the catheter fitting is formed of the second polymer material, the supplementary polymer material, or a combination thereof, the supplementary polymer material being a third polymer material having a third hardness, the third hardness being closer to the second hardness than the first hardness.

11. The method according to claim 7, characterized in that, Further includes obtaining or extruding a second section of the catheter fitting, the second section of the catheter fitting being multi-lumen, having one or more additional lumens in addition to the main lumen.

12. The method according to claim 11, characterized in that, The method further includes inserting one or more polymer rods into the one or more additional cavities before melting the polymer material in the radio frequency welding mold, the one or more polymer rods providing the supplementary polymer material.

13. The method according to claim 7, characterized in that, The method further includes, before or after forming the mandrel-mounted conduit fitting, arranging a sacrificial polymer tube above the stepped mandrel, the sacrificial polymer tube providing the supplementary polymer material.

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