Quick insertable central catheter and components thereof

Abstract

Rapidly insertable central catheters and assemblies thereof are disclosed. For example, a rapidly insertable central catheter ("RICC") can include a catheter tube, a suture wing disposed over a midsection of the catheter tube, a hub coupled to a proximal portion of the catheter tube, and a plurality of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube and a second section proximal to the first section. The suture wing can include a ledge opposite a patient-facing side of the suture wing and a needle through-hole through the ledge. The needle through-hole can be configured to receive a needle therethrough so as to insert the needle into a primary lumen of the catheter tube that passes through the suture wing through a catheter tube through-hole. Methods of RICCs can include using a RICC.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 126,997, filed December 17, 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 its components. Background Technology

[0004] The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, etc.) to introduce and advance a central venous catheter (“CVC”) through the patient’s vascular system. While the Seldinger technique is effective, the sheer number of steps is time-consuming, handling a large number of medical devices is difficult, and both can lead to patient trauma. Furthermore, the relatively high potential for contact contamination arises due to the number of medical devices that need to be exchanged during the multiple steps of the Seldinger technique. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing and advancing a catheter through a patient’s vascular system.

[0005] This article discloses a rapidly insertable central catheter (“RICC”) that addresses the aforementioned problems, RICC components, and methods thereof. Summary of the Invention

[0006] This document discloses a rapidly insertable central catheter (“RICC”) in some embodiments, comprising a catheter body, a suture wing disposed over a central portion of the catheter body, a bushing coupled to a proximal portion of the catheter body, and a plurality of extension legs extending from the bushing. The catheter body includes a first segment in a distal portion of the catheter body and a second segment proximal to the first segment. The suture wing includes an extension opposite to the patient-facing side of the suture wing and a needle port passing through the extension. The needle port is configured to receive a needle passing through it for insertion into a primary lumen of the catheter body, which passes through the suture wing via the catheter body port. The number of extension legs is equal to the number of lumens extending through the RICC.

[0007] In some embodiments, the suture flap also includes a diaphragm disposed within the needle orifice. The diaphragm is configured to provide a fluid-impermeable seal for the needle orifice during percutaneous puncture when the needle is positioned within the primary lumen of the catheter body. The diaphragm is also configured to provide a fluid-impermeable seal for the needle orifice after percutaneous puncture and once the needle has been withdrawn from the needle orifice.

[0008] In some embodiments, a first section of the catheter body is made of a first polymer material having a first hardness, and a second section of the catheter body is made of at least a second polymer material having a second hardness less than the first hardness.

[0009] In some embodiments, each of the first polymer material and the second polymer material is polyurethane.

[0010] In some embodiments, the second section includes an outer layer of the catheter body that is extruded over the inner layer of the catheter body, such that the outer diameter of the catheter body in the second section is larger than that in the first section.

[0011] In some embodiments, the catheter body further includes a bump that defines a third segment of the catheter body proximal to the second segment. The third segment has a larger outer diameter than both the first and second segments of the catheter body.

[0012] In some embodiments, the suture wing is positioned on a protrusion of the catheter body such that the needle hole is aligned with the needle eye in the catheter body, and the catheter body proximal to the suture wing has a larger outer diameter than the catheter body distal to the suture wing.

[0013] In some implementations, the RICC is a three-lumen catheter, which includes a three-branched bushing as a liner and three extension legs for extending from the bushing. Each of the three extension legs includes a Luer connector that engages with the proximal portion of the extension leg.

[0014] In some embodiments, the RICC includes a primary lumen extending from an opening in the proximal end of a first Luer connector to an opening in the distal end of a first segment of the catheter body, a secondary lumen extending from an opening in the proximal end of a second Luer connector to a first orifice in the distal portion of a second segment of the catheter body, and a tertiary lumen extending from an opening in the proximal end of a third Luer connector to a second orifice in the distal portion of the second segment of the catheter body, the second orifice being proximal to the first orifice.

[0015] This document also discloses a RICC assembly, which in some embodiments includes an RICC and a needle pre-loaded within the RICC. The RICC includes a catheter body, a suture wing disposed over a central portion of the catheter body, and a liner connected to a proximal portion of the catheter body. The catheter body includes a first segment in a distal portion of the catheter body and a second segment proximal to the first segment. The suture wing includes an extension opposite to the patient-facing side of the suture wing and a needle through-hole through the extension. The catheter passes through the suture wing via the catheter body through-hole, and the needle is inserted into the primary lumen of the catheter body via the needle through-hole of the suture wing.

[0016] In some implementations, the distal tip of the needle extends through the distal end of the catheter body to facilitate percutaneous needle insertion.

[0017] In some implementations, the RICC assembly also includes a guidewire pre-loaded within the RICC. The guidewire is inserted into the primary lumen of the catheter body proximal to the point of entry of the needle into the primary lumen of the catheter body.

[0018] In some embodiments, the suture flap also includes a diaphragm disposed within the needle orifice. The diaphragm is configured to provide a fluid-impermeable seal for the needle orifice during percutaneous puncture when the needle is positioned within the primary lumen of the catheter body. The diaphragm is also configured to provide a fluid-impermeable seal for the needle orifice after percutaneous puncture and once the needle has been withdrawn from the needle orifice.

[0019] In some embodiments, a first section of the catheter body is made of a first polymer material having a first hardness, and a second section of the catheter body is made of at least a second polymer material having a second hardness less than the first hardness.

[0020] In some embodiments, each of the first polymer material and the second polymer material is polyurethane.

[0021] In some embodiments, the second section includes an outer layer of the catheter body that is extruded over the inner layer of the catheter body, such that the outer diameter of the catheter body in the second section is larger than that in the first section.

[0022] In some embodiments, the catheter body further includes a bump that defines a third segment of the catheter body proximal to the second segment. The third segment has a larger outer diameter than both the first and second segments of the catheter body.

[0023] In some embodiments, the suture wing is positioned on a protrusion of the catheter body such that the needle hole is aligned with the needle eye in the catheter body, and the catheter body proximal to the suture wing has a larger outer diameter than the catheter body distal to the suture wing.

[0024] In some implementations, the RICC is a three-lumen catheter, which includes a three-branched bushing as a liner and three extension legs extending from the bushing. Each of the three extension legs includes a Luer connector that engages with the proximal portion of the extension leg.

[0025] In some embodiments, the RICC includes a primary lumen extending from an opening in the proximal end of a first Luer connector to an opening in the distal end of a first segment of the catheter body, a secondary lumen extending from an opening in the proximal end of a second Luer connector to a first orifice in the distal portion of a second segment of the catheter body, and a tertiary lumen extending from an opening in the proximal end of a third Luer connector to a second orifice in the distal portion of the second segment of the catheter body, the second orifice being proximal to the first orifice.

[0026] This document also discloses a method for introducing a recombinant intravascular coagulation (RICC) into a patient's vascular lumen. In some embodiments, the method includes an RICC assembly acquisition step, a needle path establishment step, an RICC advancement step, and a needle withdrawal step. The RICC assembly acquisition step includes acquiring the RICC assembly. The RICC assembly includes the RICC and a needle pre-loaded in the RICC in a ready-to-introduce state. The RICC includes a catheter body, a suture wing disposed over a central portion of the catheter body, and a bushing connected to a proximal portion of the catheter body. In the ready-to-introduce state of the RICC assembly, the axial length of the needle extends through a needle aperture, through the suture wing, and through the primary lumen of the catheter body. Additionally, in the ready-to-introduce state of the RICC assembly, the distal tip of the needle extends beyond the distal end of the catheter body. The needle path establishment step includes establishing a needle path from the skin region to the vascular lumen using the distal tip of the needle. The RICC advancement step includes advancing the distal portion of the catheter body over the needle into the vascular lumen. The needle withdrawal step includes withdrawing the needle from the RICC through the needle aperture of the suture wing.

[0027] In some embodiments, the method further includes a syringe connection step and a blood aspiration step. The syringe connection step is optional because it includes connecting the syringe to the needle if the syringe is not already connected to the needle in the ready-to-introduce state of the RICC assembly. The blood aspiration step includes aspirating blood using the syringe prior to the needle withdrawal step. The blood aspiration step confirms that the distal tip of the needle is positioned within the lumen of the blood vessel.

[0028] In some implementations, the method further includes a guidewire advancement step. The guidewire advancement step involves advancing the guidewire into the vascular lumen beyond the distal end of the catheter body after the needle withdrawal step. With the RICC assembly ready for introduction, the guidewire is pre-loaded into the RICC proximal to the needle entry point within the primary lumen of the catheter body.

[0029] In some embodiments, the catheter body includes a first segment of a first polymer material having a first hardness and a second segment of at least a second polymer material proximal to the first segment, the second polymer material having a second hardness less than the first hardness. Therefore, the catheter body is configured with column strength for advancing at least the distal portion of the catheter body into the vascular lumen without bending.

[0030] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of such concepts in more detail. Attached Figure Description

[0031] Figure 1 The diagram shows RICC components in an assembled, ready-to-be-introduced state according to some implementation schemes.

[0032] Figure 2 The RICC assembly in a disassembled state is shown according to some embodiments.

[0033] Figure 3 The RICC in a disassembled state is shown according to some embodiments.

[0034] Figure 4 An end view of the stitched wing of a RICC according to some embodiments is shown.

[0035] Figure 5 A side view of the suture flaps on the catheter body of a RICC according to some embodiments is shown.

[0036] Figure 6 Alternative combinations of stitched wings and bushings for RICC according to some implementation schemes are shown.

[0037] Figure 7 The following are illustrated according to some implementation schemes. Figure 3 The distal portion of the RICC catheter body.

[0038] Figure 8A A cross-section of the first section of a catheter body according to some embodiments is shown.

[0039] Figure 8B A cross-section of the transition between the first and second sections of a catheter body according to some embodiments is shown.

[0040] Figure 8C Another cross section is shown showing the transition between the first and second sections of the catheter body according to some embodiments.

[0041] Figure 8DA cross-section of the second section of a catheter body according to some embodiments is shown.

[0042] Figure 9 A portion of the manufacture of a catheter body according to some embodiments is shown. Detailed Implementation

[0043] 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 the specific embodiments disclosed herein may have features that allow them to be readily separable from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0044] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms 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 in a set of features or steps, and do not provide for any order or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not need to appear in that order, and a particular embodiment including such features or steps does not need to be limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0045] Regarding terms like "proximal," "proximal portion," or "proximal section" of a catheter, these terms include a portion of the catheter intended to be close to the clinician when used with a patient. Similarly, "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when used with a patient. For example, "proximal end" of a catheter includes the end of the catheter intended to be close to the clinician when used with a patient. A proximal portion, proximal section, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal section, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise suggests, a proximal portion, proximal section, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0046] Regarding terms like "distal," "distal portion," or "distal part" of a catheter, these include the portion of the catheter intended to be close to or within the patient when used with the catheter. Similarly, "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when used with the catheter. For example, "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used with the catheter. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0047] 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.

[0048] As mentioned above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient and advancing it through their vascular system. This document discloses a RICC, RICC components, and methods for addressing these issues.

[0049] The central catheter can be inserted quickly.

[0050] Figure 1 and Figure 2 RICC 100 in RICC component 102 according to some implementation schemes is shown. Figure 3 The RICC 100 in a disassembled state is shown according to some embodiments.

[0051] As shown in the figure, the RICC 100 includes a catheter body 104, a suture wing 106, a bushing 108, and a plurality of extension legs 110 extending from the bushing 108.

[0052] A suture wing 106 is disposed over the middle portion of the catheter body 104, between the proximal and distal portions. The suture wing 106 includes an extension 112 opposite to the patient-facing side of the suture wing 106 and a needle port 114 passing through the extension 112. The needle port 114 is configured to receive a needle (e.g., needle 150) passing through it for insertion into the primary lumen of the RICC 100, specifically, the primary catheter body lumen 146 of the catheter body 104, which passes through the suture wing 106 via the catheter body port 116.

[0053] The suture wing 106 also includes a diaphragm 118 disposed in the needle port 114. The diaphragm 118 is configured to provide a fluid-impermeable seal for the needle port 114 during percutaneous puncture using a needle (e.g., needle 150) when disposed in the primary lumen of the RICC 100 (e.g., the primary catheter body lumen 146 of the catheter body 104), for example, in the ready-to-introduce state of the RICC assembly 102 as described below. The diaphragm 118 is also configured to provide a fluid-impermeable seal for the needle port 114 after percutaneous puncture and withdrawal of the needle from the needle port 114.

[0054] The suture wing 106 includes a pair of wings 120, each including a plurality of wing through-holes 122 for suturing the suture wing 106 to a patient. Each of the pair of wings 120 may include one, two, three, or four wing through-holes for suturing the suture wing 106 to a patient.

[0055] Figure 6 An alternative suturewing-and-hub combination 107 for RICC 100 according to some embodiments is shown.

[0056] As shown in the figure, the suture wing-shroud assembly 107, like the suture wing 106, includes a needle through-hole 114 configured to receive a needle (e.g., needle 150) passing through it for insertion into the primary lumen of the RICC 100, specifically the primary catheter lumen 146 of the catheter body 104, which passes through the suture wing 106 via the catheter body through-hole 116.

[0057] Each of the suture wings 106 and the suture wing-shroud assembly 107 offers advantages over any other RICC currently under development in the use of the RICC 100 because the needle used to establish percutaneous puncture via the RICC 100 can be shorter than that required by other RICCs. In fact, another RICC requires a relatively long needle positioned within its primary lumen, extending from an opening in the proximal end of the other RICC (e.g., the opening of a Luer connector) to an opening in its distal end. With such a long needle, a considerable amount of time is required to observe blood return after percutaneous puncture. Additionally, such a long needle is prone to forming clots within the lumen. However, with the RICC 100, the needle can be shorter than that required by other RICCs, thus providing a relatively short time to observe blood return after percutaneous puncture and reducing the risk of clots within the lumen.

[0058] The bushing 108 is coupled to the proximal portion of the catheter body 104, for example, by inserting the proximal portion of the catheter body 104 into holes in the distal portion of the bushing 108. Although not shown, the bushing 108 also includes a plurality of holes in the proximal portion of the bushing 108, the number of which corresponds to the number of extension legs 110. The plurality of holes in the distal portion of the bushing 108 are configured to receive insertion of the plurality of extension legs 110 into the plurality of holes.

[0059] The RICC 100 can be a single-lumen catheter or a multi-lumen catheter, such as a double-lumen catheter, a triple-lumen catheter, a quadruple-lumen catheter, a quintuple-lumen catheter, or a six-lumen catheter. Therefore, the bushing 108 is either unbranched for a single-lumen catheter or branched for multiple lumens extending through the RICC 100. For example, the bushing 108 can be branched for a double-lumen catheter or for a triple-lumen catheter. Depending on the chosen manufacturing method, the bushing 108 can be molded over multiple core pins for longitudinally extending fluid paths through the bushing 108, the core pins being configured to fluidly connect multiple catheter body lumens of the catheter body 104 to multiple extension leg lumens of the multiple extension legs 110. Alternatively, the bushing 108 can be molded over multiple sleeves extending longitudinally through the bushing 108, the sleeves being configured to fluidly connect multiple catheter body lumens of the catheter body 104 to multiple extension leg lumens of the multiple extension legs 110.

[0060] The plurality of extension legs 110 extend from the bushing 108 through their distal portions. The number of extension legs 110 is equal to the number of extensions that extend through the lumen of the RICC 100. For example: if the RICC 100 is a single-lumen catheter, one extension leg extends from the bushing 108. If the RICC 100 is a double-lumen catheter, two extension legs extend from the bushing 108. If the RICC 100 is a triple-lumen catheter, three extension legs extend from the bushing 108.

[0061] The RICC 100 also includes a plurality of Luer connectors 124 for fluidly connecting a plurality of medical devices to the RICC 100. Each of the plurality of extension legs 110 includes a Luer connector of the plurality of Luer connectors 124, which is coupled to the proximal portion of the extension leg. As described above, the number of Luer connectors 124 is equal to the number of extension legs 110, which in turn is equal to the number of extensions extending through the lumen of the RICC 100. For example: if the RICC 100 is a single-lumen catheter, one extension leg extends from the bushing 108, and one Luer connector is coupled to one extension leg. If the RICC 100 is a double-lumen catheter, two extension legs extend from the bushing 108, and two Luer connectors are coupled to the two extension legs respectively. If the RICC 100 is a triple-lumen catheter, three extension legs extend from the bushing 108, and three Luer connectors are coupled to the three extension legs respectively.

[0062] The catheter body 104 includes at least a first segment 126 in the distal portion of the catheter body 104 and a second segment 128 proximal to the first segment 126. According to the method of manufacturing the catheter body 104 described below, the catheter body 104 may include a transition portion 130 between the first segment 126 and the second segment 128. In fact, according to the manufacturing method described below, the transition portion 130 and the second segment 128 of the catheter body 104 include an outer layer 132 of the catheter body 104 (see...). Figures 8B to 8D ), which is located in the inner layer 134 of the catheter body 104 (see Figures 8A to 8D The outer diameter of the catheter body 104 is squeezed out from above, so that starting from the transition 130 between the first section 126 and the second section 128 of the catheter body 104, the outer diameter of the catheter body 104 is larger in the second section 128 than in the first section 126.

[0063] The inner layer 134 of both the first segment 126 of the catheter body 104 and the transition portion 130 and the second segment 128 of the catheter body 104 may be formed of a first polymer material having a first hardness (e.g., polytetrafluoroethylene, polypropylene, or polyurethane), while the remaining portion of the transition portion 130 and the second segment 128 of the catheter body 104 (i.e., its outer layer 132) may be formed of a second polymer material having a second hardness less than, greater than, or substantially equal to the first hardness (e.g., polyvinyl chloride, polyethylene, polyurethane, or silicone). For example, each layer of the inner layer 134 and the outer layer 132 of the catheter body 104 may be made of different polyurethanes with different hardnesses (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, etc.). Polyurethane is advantageous for catheter bodies (104) because it is relatively rigid at room temperature but becomes more flexible at body temperature, reducing irritation to the blood vessel walls and phlebitis. Another advantage of polyurethane is that its thrombotic potential is lower than that of some other polymers.

[0064] Despite the above description, the first segment 126 and the second segment of the catheter body 104, comprising both the inner layer 134 and the outer layer 132, can be formed of the same polymer material (e.g., polyurethane) with the same hardness, provided that the breaking strength of the catheter body 104 is sufficient to prevent the catheter body 104 from bending when inserted into the insertion site and advanced through the patient's vascular system. In any given embodiment, the breaking strength of the catheter body 104 is noteworthy because it allows for rapid insertion of the catheter body 104 into the insertion site and advancement of the catheter body 104 through the patient's vascular system without the use of the Seldinger technique.

[0065] It should be understood that the first hardness and the second hardness can have different scales (e.g., type A or type D). Therefore, even if the second hardness of the second polymer material is less than the first hardness of the first polymer material, the second hardness may not be numerically less than the first hardness. Similarly, even if the second hardness of the second polymer material is greater than the first hardness of the first polymer material, the second hardness may not be numerically greater than the first hardness. In other words, the hardness of the second polymer material can still be less than or greater than the hardness of the first polymer material, because different scales—each ranging from 0 to 100—are designed to characterize different materials in a group of materials with similar hardness.

[0066] The catheter body 104 may include a third segment 136 proximal to the second segment 128 of the catheter body 104, the third segment including a protrusion diameter defined by a protrusion 138 in the intermediate portion of the catheter body 104. The third segment 136 of the catheter body 104 has a larger outer diameter than both the first segment 126 and the second segment 128 of the catheter body 104. Figure 1 and Figure 2 As shown, the suture wing 106 can be positioned on the protrusion 138 such that the needle aperture 114 is aligned with an optional needle eye 140 in the catheter body 104. Therefore, the catheter body 104 proximal to the suture wing 106 (also referred to herein as the catheter body extension) has a larger outer diameter than the catheter body 104 distal to the suture wing 106. This larger outer diameter of the third segment 136 of the catheter body 104 proximal to the suture wing 106 provides a thicker, more kink-resistant catheter body wall, which allows the bushing 108 and the multiple extension legs 110 to bend away from the patient's head or neck during RICC 100 use. Additionally, any lumen present in the catheter body 104 can have a larger diameter in the third segment 136 of the catheter body 104 proximal to the suture wing 106 than distal to it. This prevents a decrease in flow rate, especially when the third segment 136 of the catheter body 104 proximal to the suture wing 106 is away from the patient's head or neck and is bent.

[0067] The catheter body 104 between the suture wing 106 and the bushing 108 may have an inverted tapered shape, wherein the larger outer diameter of the catheter body 104 continues to increase from the suture wing 106 to the bushing 108. In other words, the catheter body 104 gradually tapers from the bushing 108 to the suture wing 106, but continues to have a larger outer diameter than the catheter body 104 distal to the suture wing 106. Associated with the continuously increasing outer diameter of the catheter body 104 from the suture wing 106 to the bushing 108, the thickness of the catheter body wall may continuously increase, the cross-sectional area of ​​any lumen of the catheter body 104 may continuously increase, or a combination thereof. Therefore, the catheter body 104 between the suture wing 106 and the bushing 108 may be more resistant to kinking and flow rate reduction, especially when the catheter body 104 proximal to the suture wing 106 is bent away from the patient's head or neck. Despite the above, the conduit body 104 between the suture wing 106 and the bushing 108 may alternatively have a constant diameter from the suture wing 106 to the bushing 108.

[0068] Advantageously, the catheter body 104 between the suture wing 106 and the bushing 108, i.e., the third segment 136 or catheter body extension of the catheter body 104, is a single catheter body configured to reduce bacterial entry between the dressing applied to the suture wing 106 and the patient's skin. Existing CVCs or peripherally inserted central catheters (“PICCs”) have multiple extension legs extending from the suture wing-bushing combination common to CVCs and PICCs. These multiple extension legs in a CVC or PICC provide multiple pathways for microbial entry below the dressing. The catheter body 104 is a single catheter body at least between the suture wing 106 and the bushing 108, which allows the dressing to be clamped more tightly around the catheter body 104 than is possible with the multiple extension legs of existing CVCs or PICCs. For example, the dressing can easily wrap around the entire catheter body 104 and clamp together between the catheter body 104 and the patient below the catheter body 104. Conversely, even when the dressing is wrapped around multiple extension legs of an existing CVC or PICC as described for the catheter body extension, gaps remain between adjacent extensions for bacterial entry. Therefore, the catheter body 104, as a single catheter body, restricts bacterial entry between the dressing applied to the suture wing 106 and the patient's skin.

[0069] The catheter body 104 between the suture wing 106 and the bushing 108, as well as the third segment 136 or extension of the catheter body 104, are also configured to reduce patient discomfort caused by the proximity of the plurality of extension legs 110 to the patient's head or neck. As described above, the third segment 136 of the catheter body 104 proximal to the suture wing 106 provides a thicker, more kink-resistant catheter wall; however, the third segment 136 of the catheter body 104 is flexible enough to allow the catheter body 104 to bend away from the patient's head or neck and to be secured to the patient for his or her comfort.

[0070] Figure 7 The distal portion of the catheter body 104 of the RICC 100 according to some embodiments is shown. Figures 8A to 8D Various cross sections of the conduit body 104 according to some embodiments are shown.

[0071] Similarly, RICC 100 can be a single-lumen catheter or a multi-lumen catheter, such as a double-lumen catheter, a triple-lumen catheter, a quadruple-lumen catheter, a quintuple-lumen catheter, or a six-lumen catheter. The catheter body 104 can correspondingly be a single-lumen catheter body or a multi-lumen catheter body, such as a double-lumen catheter body, a triple-lumen catheter body, a quadruple-lumen catheter body, a quintuple-lumen catheter body, or a six-lumen catheter body.

[0072] When RICC 100 is configured as follows Figures 1 to 3 , Figure 7 and Figures 8A to 8D In the case of the three-lumen catheter shown, the RICC 100 includes a primary lumen, a secondary lumen, and a tertiary lumen. The primary lumen extends from an opening in the proximal end of a first Luer connector of the plurality of Luer connectors 124 to an opening in the distal or distal end of a first segment 126 of the catheter body 104. The secondary lumen extends from an opening in the proximal end of a second Luer connector of the plurality of Luer connectors 124 to an orifice 142 in the distal portion of a second segment 128 of the catheter body 104. The tertiary lumen extends from an opening in the proximal end of a third Luer connector of the plurality of Luer connectors 124 to an orifice 144 proximal to the orifice 142 in the distal portion of the second segment 128 of the catheter body 104. Each of the primary, secondary, and tertiary lumens is further described in separate paragraphs below.

[0073] The primary lumen of RICC 100 includes a fluid-connected lumen segment comprising a primary catheter lumen 146 extending along the entire length of the catheter body 104, a primary fluid channel or primary sleeve lumen of the bushing 108, primary extension leg lumens of the first extension legs of the plurality of extension legs 110, and primary Luer connector lumens of the first Luer connectors of the plurality of Luer connectors 124.

[0074] The secondary lumen of the RICC 100 includes a fluid-connected lumen segment comprising a secondary catheter lumen 148 extending proximally from an orifice 142 in the distal portion of the second segment 128 of the catheter body 104 along the remainder of the catheter body 104. The fluid-connected lumen segment of the secondary lumen of the RICC 100 also includes a secondary fluid passage or secondary sleeve lumen of the bushing 108, secondary extension leg lumens of the second extension legs of the plurality of extension legs 110, and secondary Luer connector lumens of the second Luer connectors of the plurality of Luer connectors 124.

[0075] The tertiary lumen of the RICC 100 includes a fluid-connected lumen segment comprising a tertiary catheter lumen 149 extending proximally along the remainder of the catheter body 104 from an orifice 144 in the distal portion of the second segment 128 of the catheter body 104. The fluid-connected lumen segment of the tertiary lumen of the RICC 100 also includes a tertiary fluid channel or tertiary sleeve lumen of the bushing 108, tertiary extension leg lumens of the third extension legs of the plurality of extension legs 110, and tertiary Luer connector lumens of the third Luer connectors of the plurality of Luer connectors 124.

[0076] When the RICC 100 is configured as a dual-lumen catheter, it includes a primary lumen and a secondary lumen. Similar to the RICC 100 configured as a triple-lumen catheter, the primary lumen extends from an opening in the proximal end of a first Luer connector of a plurality of Luer connectors 124 to an opening in the distal or distal end of a first segment 126 of the catheter body 104. The secondary lumen extends from an opening in the proximal end of a second Luer connector of a plurality of Luer connectors 124 to an orifice 142 in the distal portion of a second segment 128 of the catheter body 104. Because the primary and secondary lumens of the RICC 100 configured as a dual-lumen catheter are similar to those of the RICC 100 configured as a triple-lumen catheter, additional details of each lumen of the primary and secondary lumens of the RICC 100 configured as a dual-lumen catheter can be discerned from the above description of the primary and secondary lumens of the RICC 100 configured as a triple-lumen catheter.

[0077] When the RICC 100 is configured as a single-lumen catheter, the RICC 100 includes a single lumen, which, for consistency with the above description, is also referred to herein as the primary lumen. Similar to the RICC 100 configured as a three-lumen catheter, the primary lumen extends from an opening in the proximal end of the first Luer connector among the plurality of Luer connectors 124 to an opening in the distal or distal end of the first segment 126 of the catheter body 104. Because the primary lumen of the RICC 100 configured as a single-lumen catheter is similar to that of the RICC 100 configured as a three-lumen catheter, additional details regarding the primary lumen of the RICC 100 configured as a single-lumen catheter can be seen from the above description of the primary lumen of the RICC 100 configured as a three-lumen catheter.

[0078] RICC components

[0079] Figure 1 and Figure 2 RICC component 102 according to some embodiments is shown. In particular, Figure 1 The diagram shows an assembled, ready-to-be-introduced RICC component 102 according to some embodiments, while Figure 2 The RICC assembly 102 in a disassembled state is shown according to some embodiments.

[0080] As shown in the figure, the RICC assembly 102 includes at least an RICC 100 and a needle 150, which is pre-loaded in the RICC 100 in a ready-to-be-introduced state. Optionally, the RICC assembly 102 includes a guidewire 152 pre-loaded in the RICC 100, a syringe 154 coupled to a bushing of the needle 150, or both the guidewire 152 and the syringe 154 in a ready-to-be-introduced state. In its packaged state, the RICC assembly 102 resembles its ready-to-be-introduced state; however, if the syringe 154 is present in the package including the RICC assembly 102, the syringe 154 does not need to be coupled to the bushing of the needle 150. In fact, the syringe 154 can be packaged side-by-side with the remainder of the RICC assembly 102 in its packaged state.

[0081] With the RICC assembly 102 in the ready-to-introduce state, the needle 150 is inserted into the primary lumen of the RICC 100 through the needle port 114 of the suture wing 106. Specifically, the needle 150 is inserted into the primary lumen 146 of the catheter body 104, which passes through the suture wing 106 via the catheter body port 116. Additionally, the distal tip of the beveled needle 150 extends beyond the distal end of the catheter body 104 to facilitate percutaneous puncture.

[0082] With the RICC assembly 102 in the ready-to-introduce state, guidewire 152 is inserted into the primary lumen of the RICC 100 through an opening in the proximal end of the first Luer connector of the plurality of Luer connectors 124. The distal end of guidewire 152 is proximal to the point of entry of needle 150 in the primary lumen of the RICC 100, specifically, proximal to the primary catheter lumen 146 of the catheter body 104. This placement of guidewire 152 in the ready-to-introduce state of the RICC assembly 102 allows guidewire 152 to be advanced into the patient's vascular lumen immediately after percutaneous puncture with needle 150 and withdrawal from the RICC 100. This placement of guidewire 152 in the ready-to-introduce state of the RICC assembly 102 is superior to placing guidewire 152 within needle 150 because it allows guidewire 152 to have a larger diameter than is permitted by needle 150, which provides greater stability to catheter body 104 when manipulated on guidewire 152.

[0083] method

[0084] The methods described above for RICCs and RICC components include methods for manufacturing and using RICCs and RICC components. An example method for manufacturing RICC 100 is described below, followed by a method for using RICC component 102, particularly a method for introducing RICC 100 into the lumen of a patient's blood vessel.

[0085] A method for manufacturing RICC 100 includes one or more catheter body manufacturing steps for manufacturing catheter body 104, one or more extrusion steps for extruding one or more extrudable components (e.g., a plurality of extension legs 110) other than catheter body 104, one or more molding steps for molding one or more moldable components, and one or more assembly steps for assembling RICC 100 or any part thereof by joining the extrudable and moldable components including catheter body 104 together.

[0086] Figure 9 A portion of the manufacture of a catheter body 104 according to some embodiments is shown.

[0087] The one or more catheter body manufacturing steps include an inner layer forming step. The inner layer forming step includes forming an inner layer 134 of the catheter body 104 by extruding a single-lumen tube 156 of a first polymer material.

[0088] The manufacturing steps of the one or more conduit bodies also include an insertion step. The insertion step includes inserting one end of a single-lumen tube 156 through a die 158 passing through an extruder 160.

[0089] The one or more conduit body manufacturing steps further include a second layer forming step. The second layer forming step includes forming an outer layer 132 of the conduit body 104 by periodically forcing a melt 162 of a second polymer material around a single-lumen tube 156 through a mold 158, thereby forming an output tube, wherein segments of the mixed-layer tube 164 are regularly distributed with segments of the single-lumen tube 156.

[0090] The one or more conduit body manufacturing steps may also include an adhesive layer application step. The adhesive layer application step includes applying an adhesive layer on the single-lumen tube 156 before forcing the melt 162 of the second polymer material around the single-lumen tube 156 through the mold 158 in the second layer forming step.

[0091] The one or more catheter body manufacturing steps also include an inner lumen forming step. The inner lumen forming step includes forming one or more additional cavities (e.g., secondary catheter inner lumen 148, tertiary catheter inner lumen 149, etc.) in the inner lumen of the single-lumen tube 156 by injecting air into the melt 162 of the second polymer material while forcing the melt 162 of the second polymer material around the single-lumen tube 156 through a mold 158.

[0092] The manufacturing steps of the one or more conduit bodies also include a perforation generation step. The perforation generation step includes generating one or more perforations (e.g., pinholes 140, 142, 144, etc.) in a segment of the mixed-layer tubing 164 to correspondingly create one or more openings into the primary conduit body lumen 146 or the one or more additional lumens.

[0093] The one or more conduit body manufacturing steps may also include a bump forming step. The bump forming step includes forming bumps (e.g., bumps 138 in the middle portion of the conduit body 104) in a segment of the mixed-layer tubing 164 by periodically slowing down the rate at which the output tubing is drawn with a puller to increase the outer diameter of the output tubing after the bump.

[0094] The one or more conduit body manufacturing steps may also include a reverse-tapering step. The reverse-tapering step involves tapering the outer diameter of the segment of the mixed-layer conduit 164 after the bump by continuously slowing down the rate at which the conduit is pulled out with a puller.

[0095] The manufacturing steps of one or more conduit bodies may also include a cooling step. The cooling step includes drawing the output tubing through a cooling tank using a puller to cool the output tubing.

[0096] The one or more catheter body manufacturing steps also include a cutting step. The cutting step includes cutting the output tubing in at least several segments of the single-lumen tubing 156 with a cutter to form a catheter body, such as catheter body 104.

[0097] The one or more extrusion steps may include extruding any one or more of the plurality of extension legs 110 in accordance with the description set forth above for the one or more extension legs.

[0098] The one or more molding steps may include molding any one or more moldable parts selected from the stitching wing 106 and bushing 108 in accordance with the description of such moldable parts set forth above. The one or more molding steps may also include molding any one or more of the plurality of Luer connectors 124 in accordance with the description of such one or more Luer connectors set forth above.

[0099] The assembly steps of assembling RICC 100 or any part thereof may include, according to Figure 3 As shown in the assembly of RICC 100, it should be understood that the distal portion of the catheter body 104 is inserted into the proximal portion of the suture wing 106.

[0100] A method for introducing RICC 100 into the lumen of a patient's blood vessel includes an RICC assembly acquisition step, a needle path establishment step, a first RICC advancement step and a second RICC advancement step, and a needle withdrawal step.

[0101] The RICC assembly acquisition step includes obtaining RICC assembly 102. As described above, RICC assembly 102 includes at least RICC 100 and needle 150, which are pre-loaded in the RICC in a ready-to-introduce state. Specifically, in the ready-to-introduce state of RICC assembly 102, the axis of needle 150 extends through the needle through-hole 114 of the suture wing 106 and the primary lumen of RICC 100, specifically, the primary catheter lumen 146 of the catheter body 104. Additionally, in the ready-to-introduce state of RICC assembly 102, the distal tip of needle 150 extends beyond the distal end of catheter body 104.

[0102] The needle tract establishment process involves using the distal tip of the needle 150 to create a needle tract from the skin area to the lumen of the blood vessel.

[0103] The first RICC advancement step involves advancing the distal portion of the catheter body 104 into the vascular lumen above the needle 150.

[0104] The needle withdrawal step includes withdrawing the needle 150 from the RICC 100 through the needle through hole 114 of the suture wing 106.

[0105] The second RICC advancement step involves advancing the catheter body 104 through the patient's vascular system without necessarily using the Seldinger technique. For example, if the insertion site is in the right subclavian vein or right internal jugular vein, the second RICC advancement step may include further inserting the catheter body 104 into the insertion site such that the catheter body 104, or at least its distal portion, is advanced through the right subclavian vein or right internal jugular vein, right brachiocephalic vein, and into the superior vena cava. Other insertion sites, such as in the left subclavian vein or left internal jugular vein, require advancing the distal portion of the catheter body 104 through the corresponding vascular system. Because the catheter body 104 has sufficient fracture strength to prevent bending when inserted into the insertion site and advanced through the patient's vascular system, the Seldinger technique is not required.

[0106] The method may further include a syringe connection step and a blood aspiration step. The syringe connection step is optional because it includes connecting the syringe 154 to the bushing of the needle 150 if the syringe 154 is not already connected to the needle 150 in the ready-to-be-introduced state of the RICC assembly 102. The blood aspiration step includes aspirating blood with the syringe 154 prior to the needle withdrawal step. The blood aspiration step confirms that the distal tip of the needle 150 is positioned within the lumen of the patient's blood vessel.

[0107] The method may also include a guidewire advancement step following the needle withdrawal step. The guidewire advancement step involves advancing the guidewire 152 into the patient's vascular lumen beyond the distal end of the catheter body 104 after the needle withdrawal step. As described above, in the ready-to-introduce state of the RICC assembly 102, the guidewire 152 is pre-loaded in the RICC 100, proximal to the point of entry of the needle 150 in the primary lumen of the RICC 100, specifically, in the primary catheter body lumen 146 of the catheter body 104.

[0108] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable 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 these adaptations and / or modifications are also covered in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A central catheter that can be quickly inserted, characterized in that, include: The catheter body comprises: The first section, located in the distal portion of the catheter body; and The second segment is located near the first segment; A suture wing, disposed over the middle portion of the catheter body and its needle hole, the suture wing comprising: The protrusion, which faces the patient-facing side of the suture wing; and A needle through-hole, which passes through the protrusion, is configured to receive a needle passing through the needle through-hole, so that the needle can be inserted through the needle hole of the catheter body and into the primary lumen of the catheter body, the catheter body passing through the suture wing through the catheter body through-hole; A bushing, which is connected to the proximal portion of the catheter body; and Multiple extension legs extend from the bushing, the number of which is equal to the number of extension legs extending through the lumen of the rapidly insertable central catheter.

2. The rapidly insertable central catheter according to claim 1, characterized in that, The suture flap also includes a diaphragm disposed in the needle orifice, the diaphragm being configured to provide a fluid-proof seal to the needle orifice during percutaneous puncture when the needle is positioned in the primary lumen of the catheter body or after the needle is withdrawn from the needle orifice following percutaneous puncture.

3. The rapidly insertable central catheter according to claim 1, characterized in that, The first section of the catheter body is made of a first polymer material having a first hardness, while at least a portion of the second section of the catheter body is made of a second polymer material having a second hardness less than the first hardness.

4. The rapidly insertable central catheter according to claim 3, characterized in that, Each of the first polymer material and the second polymer material is polyurethane.

5. The rapidly insertable central catheter according to claim 1, characterized in that, The second section includes the outer layer of the catheter body, which is extruded over the inner layer of the catheter body, such that the outer diameter of the catheter body in the second section is larger than that in the first section.

6. The rapidly insertable central catheter according to claim 1, characterized in that, The catheter body also includes a protrusion that defines a third segment of the catheter body proximal to the second segment, the third segment having a larger outer diameter than both the first and second segments of the catheter body.

7. The rapidly insertable central catheter according to claim 6, characterized in that, The suture wing is positioned on the protrusion of the catheter body such that the needle hole is aligned with the needle eye in the catheter body, and the catheter body proximal to the suture wing has a larger outer diameter than the catheter body distal to the suture wing.

8. The rapidly insertable central catheter according to claim 1, characterized in that, The quick-insertion central catheter is a three-lumen catheter, which includes a three-branched bushing as the bushing and three extension legs for extending from the bushing, each of the three extension legs including a Luer connector connected to the proximal portion of the plurality of extension legs.

9. The rapidly insertable central catheter according to claim 8, characterized in that, The rapidly insertable central catheter includes: a primary lumen extending from an opening in the proximal end of a first Luer connector to an opening in the distal end of a first segment of the catheter body; a secondary lumen extending from an opening in the proximal end of a second Luer connector to a first orifice in a distal portion of a second segment of the catheter body; and a tertiary lumen extending from an opening in the proximal end of a third Luer connector to a second orifice in a distal portion of the second segment of the catheter body, the second orifice being proximal to the first orifice.

10. A rapidly insertable central catheter assembly, characterized in that, include: A rapidly insertable central catheter, comprising: The catheter body comprises: The first section, located in the distal portion of the catheter body; and The second segment is located near the first segment; A suture wing, disposed over the middle portion of the catheter body and its needle hole, the suture wing comprising: The protrusion, which faces the patient-facing side of the suture wing; and A needle through-hole, which passes through the protrusion, through which the catheter body passes through the suture wing; and A bushing, which is connected to the proximal portion of the catheter body; and A needle, pre-loaded in the quick-insertion central catheter, is inserted into the primary lumen of the catheter body via the needle eye of the catheter body and the needle through-hole of the suture wing.

11. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The distal tip of the needle extends through the distal end of the catheter body to facilitate percutaneous puncture.

12. The rapidly insertable central catheter assembly according to claim 10, characterized in that, It also includes a guidewire pre-loaded in the quick-insertion central catheter, the guidewire being inserted into the primary lumen of the catheter body proximal to the point of entry of the needle into the primary lumen of the catheter body.

13. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The suture flap also includes a diaphragm disposed in the needle orifice, the diaphragm being configured to provide a fluid-impermeable seal to the needle orifice during percutaneous puncture when the needle is positioned in the primary lumen of the catheter body or after percutaneous puncture when the needle is withdrawn from the needle orifice.

14. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The first section of the catheter body is made of a first polymer material having a first hardness, while at least a portion of the second section of the catheter body is made of a second polymer material having a second hardness less than the first hardness.

15. The rapidly insertable central catheter assembly according to claim 14, characterized in that, Each of the first polymer material and the second polymer material is polyurethane.

16. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The second section includes the outer layer of the catheter body, which is extruded over the inner layer of the catheter body, such that the outer diameter of the catheter body in the second section is larger than that in the first section.

17. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The catheter body also includes a protrusion that defines a third segment of the catheter body proximal to the second segment, the third segment having a larger outer diameter than both the first and second segments of the catheter body.

18. The quick-insertion central catheter assembly according to claim 17, characterized in that, The suture wing is positioned on the protrusion of the catheter body such that the needle hole is aligned with the needle eye in the catheter body, and the catheter body proximal to the suture wing has a larger outer diameter than the catheter body distal to the suture wing.

19. The rapidly insertable central catheter assembly according to claim 10, characterized in that, The quick-insertion central catheter is a three-lumen catheter, which includes a three-branched bushing as the bushing and three extension legs for extending from the bushing, each of the three extension legs including a Luer connector connected to the proximal portion of each extension leg.

20. The quick-insertion central catheter assembly according to claim 19, characterized in that, The rapidly insertable central catheter includes: a primary lumen extending from an opening in the proximal end of a first Luer connector to an opening in the distal end of a first segment of the catheter body; a secondary lumen extending from an opening in the proximal end of a second Luer connector to a first orifice in a distal portion of a second segment of the catheter body; and a tertiary lumen extending from an opening in the proximal end of a third Luer connector to a second orifice in a distal portion of the second segment of the catheter body, the second orifice being proximal to the first orifice.

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