Catheter Assembly

Abstract

Rapidly insertable central catheters (RICCs) and methods thereof are disclosed, including a catheter assembly. The catheter assembly can include an introducer catheter, an introducer needle, and a RICC. The introducer needle can be positioned within the introducer-catheter lumen of the introducer catheter to form an introducer combination. The RICC can include a catheter tube including an introducer lumen having several lumens and a side opening extending through the side of the catheter tube. The side opening opens into the introducer lumen at the distal end of the catheter tube. The introducer combination can be positioned through the side opening, along the distal end of the catheter tube, within the introducer lumen, and through the distal end of the catheter tube to introduce the RICC into a patient's blood vessel.

Description

[Technical field]

[0001] The present invention relates to a rapidly insertable central catheter including a catheter assembly and method thereof. [Background technology]

[0002] Central venous catheters (CVCs) are formed from materials having a relatively low durometer, which contributes to CVCs having a lack of column strength. Due to the lack of column strength, CVCs are generally introduced into a patient and advanced through the patient's vasculature by the Seldinger technique. The Seldinger technique utilizes several steps and medical instruments (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming and handling many medical instruments is inconvenient, both of which can lead to trauma to the patient. In addition, due to the many medical instruments that need to be replaced during the many steps of the Seldinger technique, the potential for contact contamination is relatively high. Thus, there is a need to reduce the number of steps and medical instruments involved in introducing a catheter such as a CVC into a patient and advancing the catheter through its vasculature.

[0003] Disclosed herein are rapidly insertable central catheters (RICCs) and methods thereof that address the above-mentioned problems. Summary of the Invention

[0004] Disclosed herein is a method for inserting a RICC into a vascular lumen of a patient, which in some embodiments includes the steps of obtaining a catheter assembly, establishing a needle path, removing an introducer needle, advancing an introducer catheter, and advancing a RICC. The obtaining catheter assembly includes obtaining a catheter assembly including an introducer combination and a RICC. The introducer combination includes an introducer needle disposed within an introducer-catheter lumen of the introducer catheter. The RICC includes a catheter tube having an introducer lumen and a side opening through a side of the catheter tube that opens into the introducer lumen. The introducer combination is disposed through the side opening, along a distal end of the catheter tube within the introducer lumen, and through the distal end of the catheter tube. The establishing needle path includes establishing a needle path at a tip of the introducer needle. The needle path extends from an area of ​​the skin to the vascular lumen of the patient. The introducer needle removal step includes removing the introducer needle from the introducer combination, leaving the introducer catheter in place. The introducer catheter advancement step includes advancing the introducer catheter into the vessel lumen. The RICC advancement step includes advancing the RICC on the introducer catheter into the vessel lumen until a distal end of the RICC is coincident with the distal end of the introducer catheter, until the RICC is extruded from the introducer catheter, or until the distal end of the RICC is not extruded from the introducer catheter but passes through the distal end of the introducer catheter.

[0005] In some embodiments, the method further comprises an introducer combination placement step of placing the introducer combination within a side opening of the catheter tube.

[0006] In some embodiments, the method further includes an introducer combination adjustment step and a needle tip assurance step. The introducer combination adjustment step includes adjusting the introducer combination such that at least about 1-7 cm of the introducer combination extends from the distal end of the RICC. The needle tip assurance step includes ensuring that the tip of the introducer needle extends beyond the distal end of the introducer catheter prior to establishing the needle pathway.

[0007] In some embodiments, the method further includes aspirating blood using a syringe fluidly connected to the introducer needle to ensure that the tip of the introducer needle is positioned within the vessel lumen before removing the introducer needle from the introducer combination.

[0008] In some embodiments, the introducer catheter advancing step includes advancing the introducer catheter at least about 1-7 cm into the vessel lumen. Advancing the introducer catheter at least about 1-7 cm into the vessel lumen ensures that the introducer catheter is sufficiently positioned within the vessel lumen prior to the RICC advancing step.

[0009] In some embodiments, in the RICC advancement step, the RICC is advanced over the introducer catheter into the blood vessel lumen until the distal end of the RICC is coincident with the distal end of the introducer catheter or until the distal end of the RICC passes through the distal end of the introducer catheter without being pushed out of the introducer catheter.

[0010] In some embodiments, the method further comprises an introducer catheter removal step of removing the introducer catheter from the RICC through a side opening penetrating the side of the catheter tube.

[0011] In some embodiments, in the RICC advancement step, advancing the RICC over the introducer catheter into the blood vessel lumen until the RICC is pushed out of the introducer catheter simultaneously removes the introducer catheter from the RICC through a side opening penetrating the side of the catheter tube.

[0012] Also disclosed herein, in some embodiments, is a RICC including a catheter tube, a hub, and several extension legs extending from the hub. The catheter tube includes an introduction lumen of several catheter tube lumens and a side opening penetrating a side of the catheter tube. The introduction lumen extends from a proximal end of the catheter tube to a distal end of the catheter tube. The side opening opens into the introduction lumen at the distal end of the catheter tube. The catheter tube is configured to receive an introducer needle, an introducer catheter, or a combination thereof through the side opening, along the distal end of the catheter tube within the introduction lumen, and through the distal end of the catheter tube to introduce the RICC into a blood vessel of a patient. A hub is attached to a proximal end of the catheter tube. The hub includes a number of hub lumens equal to the number of catheter tube lumens. The number of extension legs extending from the hub is equal to the number of catheter tube lumens. Each of the several extension legs includes an extension leg lumen.

[0013] In some embodiments, the side opening is configured to seal when the introducer needle, introducer catheter, or a combination thereof is removed from the RICC.

[0014] In some embodiments, the side opening is a perforation established by an introducer needle, an introducer catheter, or a combination thereof. At least the catheter tube around the perforation is formed from an elastomeric material that is configured to return to its default state when the introducer needle, the introducer catheter, or a combination thereof is removed from the perforation. The catheter tube around the perforation seals the perforation when it returns to its default state.

[0015] In some embodiments, the catheter tube includes a flap covering and / or extending into the side opening configured to be held open by the introducer needle, introducer catheter, or combination thereof. The flap is configured to return to its default state when the introducer needle, introducer catheter, or combination thereof is removed from the side opening. The flap seals the side opening when it returns to its default state.

[0016] In some embodiments, the catheter tube includes a reinforced region around the side opening, the reinforced region configured to maintain the integrity of the catheter tube around the side opening.

[0017] In some embodiments, the number of catheter tube lumens, the number of hub lumens, and the number of extension leg lumens is three. The RICC includes a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen. The set of three lumens is formed from fluidly connected portions of the catheter tube lumens, the hub lumen, and the extension leg lumens.

[0018] In some embodiments, the distal lumen has a distal lumen opening at the distal end of the RICC, the middle lumen has a middle lumen opening on a side of the catheter tube distal to the side opening, and the proximal lumen has a proximal lumen opening on a side of the catheter tube distal to the side opening but proximal to the middle lumen opening.

[0019] Also disclosed herein in some embodiments is a catheter assembly including an introducer catheter, an introducer needle, and a RICC. The introducer needle is disposed within an introducer-catheter lumen of the introducer catheter to form an introducer combination. The RICC has a catheter tube including an introducer lumen among several catheter tube lumens and a side opening through a side of the catheter tube. The introducer lumen extends from a proximal end of the catheter tube to a distal end of the catheter tube. The side opening opens into the introducer lumen at the distal end of the catheter tube. The introducer combination is disposed through the side opening, along the distal end of the catheter tube within the introducer lumen, and through the distal end of the catheter tube to introduce the RICC into a blood vessel of a patient.

[0020] In some embodiments, the catheter assembly further includes a syringe including a tip extending from the barrel of the syringe, the tip configured as a luer connector for connecting to a hub of the introducer needle, the hub configured as a complementary luer connector.

[0021] In some embodiments, the side opening is configured to seal when the introducer catheter is removed from the RICC. In some embodiments, the side opening is a perforation established by the introducer needle. At least the catheter tube around the perforation is formed from an elastomeric material configured to return to its default state when the introducer catheter is removed from the perforation. The catheter tube around the perforation seals the perforation when it returns to its default state.

[0022] In some embodiments, the catheter tube includes a flap covering and / or extending into the side opening configured to be held open by the introducer catheter. The flap is configured to return to its default state when the introducer catheter is removed from the side opening. The flap seals the side opening when it returns to its default state.

[0023] In some embodiments, the catheter tube includes a reinforced region around the side opening, the reinforced region configured to maintain the integrity of the catheter tube around the side opening.

[0024] In some embodiments, the RICC further includes a hub and a number of extension legs extending from the hub. The hub is attached to a proximal end of the catheter tube. The hub includes a number of hub lumen equal to the number of catheter tube lumens. The number of extension legs extending from the hub is equal to the number of catheter tube lumens. Each of the number of extension legs includes an extension leg lumen.

[0025] In some embodiments, the number of catheter tube lumens, the number of hub lumens, and the number of extension leg lumens is three. The RICC includes a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen. The set of three lumens is formed from fluidly connected portions of the catheter tube lumens, the hub lumen, and the extension leg lumens.

[0026] In some embodiments, the distal lumen has a distal lumen opening at the distal end of the RICC, the middle lumen has a middle lumen opening on a side of the catheter tube distal to the side opening, and the proximal lumen has a proximal lumen opening on a side of the catheter tube distal to the side opening but proximal to the middle lumen opening.

[0027] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 shows a diagram of a catheter assembly including a RICC, according to some embodiments. [Diagram 2] FIG. 2 shows the distal end of a catheter tube of a RICC, according to some embodiments. [Diagram 3] FIG. 3 illustrates a first transverse cross-section of a catheter tube according to some embodiments. [Figure 4] FIG. 4 shows a second or third transverse cross section of a catheter tube according to some embodiments. [Diagram 5] FIG. 5 shows a side opening in the side of a catheter tube, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Before some specific embodiments are disclosed 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 can be easily separated from the specific embodiment and can be combined or substituted in any way with any of the other several embodiments disclosed herein.

[0030] With respect to the terms used herein, it should also be understood that the terms are intended to describe certain particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequentiality or numerical limitations. For example, the "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment that includes such features or steps be limited to those three features or steps. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a particular fixed position, orientation, direction, etc. Rather, such designations are used to reflect, for example, a relative position, orientation, direction, etc. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0031] For example, references to the "proximal," "proximal portion," or "proximal end" of a catheter disclosed herein include the portion of the catheter that is intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be located near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be located near the clinician when the catheter is used on a patient. The proximal portion, end, or length of a catheter may include the proximal end of the catheter. However, the proximal portion, end, or length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, end, or length of a catheter is not the terminal portion, or length of the catheter.

[0032] For example, references to the "distal," "distal portion," or "distal end" of a catheter disclosed herein include the portion of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. The distal portion, end, or length of a catheter may include the distal end of the catheter. However, the distal portion, end, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, end, or length of a catheter is not the terminal portion, or length of the catheter.

[0033] With reference to "several" features or steps, the several features or steps include one or more features or steps. For example, the several catheter tube lumens of a catheter tube are intended to be one or more catheter tube lumens of a catheter tube. Similarly, the several extension legs of a catheter are intended to be one or more extension legs of a catheter.

[0034] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0035] As discussed above, there is a need to reduce the number of steps and medical instruments involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the vasculature. Disclosed herein are RICCs and methods thereof that address the above-mentioned challenges.

[0036] Rapidly insertable central catheter Figure 1 shows a diagram of a catheter assembly 100 including a RICC 102, according to some embodiments. Figure 2 shows a distal end of a catheter tube 104 of a RICC 102, according to some embodiments. Figures 3 and 4 show various transverse cross sections of the catheter tube 104, according to some embodiments.

[0037] As shown, the RICC 102, in some embodiments, includes a catheter tube 104, a hub 106, and a number of extension legs 108 extending from the hub 106. The catheter tube 104, the hub 106, and the number of extension legs 108 will be described in turn below.

[0038] The catheter tube 104 includes an introduction lumen 110 among several catheter tube lumens. The introduction lumen 110 extends from a proximal end of the catheter tube 104 to a distal end of the catheter tube 104, which in some embodiments corresponds to a distal end of a tip 112 of the RICC 102. That is, in some embodiments, the tip 112 of the RICC 102 is formed from the distal end of the catheter tube 104. However, in other embodiments, the tip 112 is formed separately and coupled to the distal end of the catheter tube 104. In such embodiments, the introduction lumen 110 extends further from the distal end of the catheter tube 104 to the distal end of the tip 112. In any event, the catheter tube 104 is configured to accommodate an introducer needle, an introducer catheter, or a combination of these introducers (i.e., an introducer catheter over an introducer needle) along the distal end of the catheter tube 104 within the introduction lumen 110 and through the distal end or tip 112 of the catheter tube 104 for introducing the RICC 102 into the patient's vasculature. The distal or tip 112 of the catheter tube 104 is configured to have an engineered fit, such as a clearance fit (e.g., free running, easy running, close running, sliding, or location clearance fit) or transition fit (e.g., tight, similar, or fixed transition fit) with the introducer needle, introducer catheter, or combination of introducers, in accordance with International Organization for Standardization (ISO) geometric product specifications for tolerances, specifically ISO 286.Such an engineered fit facilitates a smooth transition from the distal end or tip 112 of the catheter tube 104 to the introducer needle, introducer catheter, or introducer combination thereof, leaving little space for skin or other tissue to become trapped between the distal end or tip 112 of the catheter tube 104 and the introducer needle, introducer catheter, or introducer combination.

[0039] The catheter tube 104 may include a side opening 114 that penetrates the side of the catheter tube 104. If present, the side opening 114 is approximately 1-4 cm from the distal or tip 112 of the catheter tube 104 and opens into an introducer lumen 110 in the distal end of the catheter tube 104. The catheter tube 104 is further configured to accommodate an introducer needle, introducer catheter, or a combination of introducers through the side opening 114, as well as along the distal end of the catheter tube 104 within the introducer lumen 110 and through the distal or tip 112 of the catheter tube 104, for introducing the RICC 102 into the patient's vasculature.

[0040] FIG. 5 shows a side opening 114 in the side of the catheter tube 104 according to some embodiments. As shown, the side opening 114 may be a self-sealing side opening configured to seal when the introducer needle, introducer catheter, or introducer combination is removed from the RICC 102.

[0041] In one example, the catheter tube 104 can include a flap 116 (e.g., a small piece of elastomeric material adhered to the catheter tube 104) covering and / or extending into the side opening 114. The flap 116 is configured to be held open by an introducer needle, introducer catheter, or introducer combination. The flap 116 is configured to return to its default state when the introducer needle, introducer catheter, or introducer combination is removed from the side opening 114. The flap 116 seals the side opening 114 when it returns to its default state.

[0042] In another example, the catheter tube 104 can include a perforation established by an introducer needle, an introducer catheter, or a combination thereof, as the side opening 114. At least the catheter tube 104 around the side opening 114 (e.g., perforation) is formed from an elastomeric material configured to return to its default state when the introducer needle, the introducer catheter, or a combination thereof is removed from the side opening 114. The catheter tube 104 around the side opening 114 (e.g., perforation) seals the side opening 114 when returning to its default state. Alternatively or additionally, the catheter tube 104 can include a region or reinforcement 118, described below, that serves the same function as the catheter tube 104 around the side opening 114 (e.g., perforation) that is formed from an elastomeric material.

[0043] Notwithstanding the above-described self-sealing form of side opening 114, side opening 114 can be configured to remain open at all times, even when the introducer needle, introducer catheter, or introducer combination is removed from side opening 114.

[0044] In the absence of the side opening 114, the middle lumen opening 120 or the proximal lumen opening 122 described below can be used for the introducer needle, introducer catheter, or introducer combination. Similar to that described above for the perforation established by the introducer needle, introducer catheter, or introducer combination as the side opening 114, the catheter tube 104 can include a perforation established by the introducer needle, introducer catheter, or introducer combination through a septum that separates the distal lumen from the middle or proximal lumen via the middle lumen opening 120 or the proximal lumen opening 122. Again, the catheter tube 104 can be formed from an elastomeric material that is configured to return to its default state and seal when the introducer needle, introducer catheter, or combination thereof is removed from the perforation via the middle lumen opening 120 or the proximal lumen opening 122.

[0045] The catheter tube 104 may include a reinforced region 118 around the side opening 114. For example, the reinforced region 118 may be a segment of the catheter tube 104 that is slightly thicker, a segment of the catheter tube 104 of a different polymeric material, such as a more durable or more elastic material, a band on the catheter tube 104 of a more durable or more elastic material, etc. The reinforced region 118 is configured to maintain the structural integrity of the catheter tube 104 around the side opening 114, such as when an introducer needle, introducer catheter, or a combination thereof is placed in the side opening 114 and the catheter assembly is being manipulated.

[0046] A hub 106 is attached to the proximal end of the catheter tube 104 . The hub 106 includes suture wings having through holes for suturing the hub 106 to the patient.

[0047] The hub 106 includes a number of hub lumens equal to the number of catheter tube lumens, each of the several hub lumens being fluidly connected to one of the several catheter tube lumens.

[0048] A number of extension legs 108 extend from the hub 106. The number of extension legs 108 is equal to the number of hub lumens, which in turn is equal to the number of catheter tube lumens. Each of the number of extension legs 108 includes an extension leg lumen fluidly connected to one of the number of hub lumens.

[0049] Although the RICC 102 may include any number of lumens, the RICC 102 of FIGS. 1-4 is of a three-lumen type, including three catheter tube lumens, three hub lumens, and three extension leg lumens. In fact, the RICC 102 includes a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen, formed from fluidly connected portions of the three catheter tube lumens, the three hub lumens, and the three extension leg lumens. As shown, the distal lumen has a distal lumen opening at the distal end of the RICC 102. The middle lumen has a middle lumen opening 120 at the side of the catheter tube 104, proximal to the distal lumen opening, but distal to the side opening 114, if present. The proximal lumen has a proximal lumen opening 122 on a side of the catheter tube 104 that is proximal to the mid lumen opening 120 but distal to the side opening 114, if present. However, the RICC 102 is not limited to the aforementioned arrangement of openings. Indeed, the distal lumen opening, mid lumen opening 120, and proximal lumen opening 122 are generally arranged as described, but the side opening 114, if present, can be distal to the mid lumen opening 120, between the mid lumen opening 120 and the proximal lumen opening 122, or proximal to the proximal lumen opening 122 as shown.

[0050] Catheter Assembly FIG. 1 shows a diagram of a catheter assembly 100 including a RICC 102, according to some embodiments.

[0051] As shown, the catheter assembly 100, in some embodiments, includes a RICC 102 and an introducer combination of an introducer needle 124 disposed within an introducer catheter 126, which is then disposed within a side opening 114 of a catheter tube 104 of the RICC 102.

[0052] The catheter assembly 100 may further include a syringe 128. The syringe 128 includes a tip extending from the barrel of the syringe 128. The tip is configured as a luer connector for connecting to the hub of the introducer needle 124, and the hub is configured as a complementary luer connector to the tip of the syringe 128.

[0053] The catheter assembly 100 may be packaged with the introducer combination disposed within the side opening 114 of the catheter tube 104 of the RICC 102 for immediate use upon removal from the package containing the catheter assembly 100. Alternatively, the catheter assembly 100 can be packaged with the introducer combination separate from the RICC 102. In either case, instructions for using the catheter assembly 100, including assembling the catheter assembly 100 (e.g., placing the introducer combination within the catheter tube 104 of the RICC 102), can be included within the package, if desired.

[0054] method A method of the catheter assembly 100 or its RICC 102 includes a method for inserting the RICC 102 into a vascular lumen of a patient. Such a method, in some embodiments, includes the steps of obtaining a catheter assembly, establishing a needle path, removing an introducer needle, advancing an introducer catheter, and advancing a RICC.

[0055] The catheter assembly obtaining step includes obtaining the catheter assembly 100 including the RICC 102 and introducer combination in or from its packaging. As described above, the RICC 102 can include a catheter tube 104 having a side opening 114 through the side of the catheter tube 104 that opens into the introducer lumen 110. The introducer combination includes an introducer needle 124 disposed within an introducer-catheter lumen of an introducer catheter 126. The introducer combination can be disposed through the side opening 114 of the RICC 102, along the distal end of the catheter tube 104 within the introducer lumen 110, and through the distal or tip 112 of the catheter tube 104.

[0056] If the catheter assembly 100 is not yet assembled, the method may further include an introducer combination placement step of placing the introducer combination within the side opening 114 of the catheter tube 104. Placing the introducer combination within the side opening 114 of the catheter tube 104 may include establishing the side opening 114 of the catheter tube 104 with the tip of an introducer needle 124.

[0057] Whether or not the catheter assembly 100 is already assembled, the method may further include an introducer combination adjustment step and a needle tip assurance step. The introducer combination adjustment step includes adjusting the introducer combination such that at least about 1-7 cm of the introducer combination extends from the distal end of the RICC 102. (See, e.g., FIG. 1.) The needle tip assurance step includes ensuring that the tip of the introducer needle 124 extends beyond the distal end of the introducer catheter 126 prior to the needle path establishment step.

[0058] The needle pathway establishment step involves establishing a needle pathway at the tip of the introducer needle 124 while the introducer combination is positioned within the RICC 102. Once established, the needle pathway will extend from the area of ​​the skin to the patient's vascular lumen.

[0059] The method may further include a blood aspirating step of aspirating blood using a syringe 128 fluidly connected to the introducer needle 124. The blood aspirating step ensures that the tip of the introducer needle 124 is positioned within the blood vessel lumen before removing the introducer needle 124 from both the patient and the introducer combination.

[0060] After the blood aspiration step, but prior to removing the introducer needle 124 from both the patient and the introducer combination, the method may further include a syringe separation step of separating the syringe 128 from the hub of the introducer needle 124. Once the syringe 128 has been removed from the hub of the introducer needle 124, an access guidewire may be advanced through the needle lumen of the introducer needle 124 and into the blood vessel lumen, in an access guidewire advancement step.

[0061] The introducer catheter advancing step includes advancing the introducer catheter 126 into the blood vessel lumen, such as over the introducer needle 124, an access guidewire extending from a needle lumen of the introducer needle 124 into the blood vessel lumen, or a combination thereof. For example, the introducer catheter advancing step includes advancing the introducer catheter 126 at least about 1-7 cm into the blood vessel lumen. Advancing the introducer catheter at least about 1-7 cm into the blood vessel lumen ensures that the introducer catheter 126 is sufficiently positioned within the blood vessel lumen prior to the RICC 102 advancing step.

[0062] The introducer needle removal step includes removing the introducer needle 124 from both the patient and the introducer combination, while leaving the introducer catheter 126 in place on both the patient and the RICC 102. If an access guidewire was advanced into the vessel lumen in the access guidewire advancement step, the introducer needle removal step can include removing the access guidewire as well.

[0063] The RICC advancement step includes advancing the RICC 102 over the introducer catheter 126 into the blood vessel lumen until the distal end of the RICC 102 is coincident with the distal end of the introducer catheter 126, until the RICC 102 is pushed out of the introducer catheter 126, or until the distal end of the RICC 102 is not pushed out of the introducer catheter 126 but passes through the distal end of the introducer catheter 126.

[0064] With respect to advancing the RICC 102 over the introducer catheter 126 into the blood vessel lumen until the distal end of the RICC 102 is flush with the distal end of the introducer catheter 126, the method may further include a first introducer catheter removal step of thereafter removing the introducer catheter 126 from the RICC 102 through a side opening 114 penetrating the side of the catheter tube 104. Once the introducer catheter 126 has been removed from the RICC 102 through the side opening 114 of the catheter tube 104, the introducer catheter 126 may be completely removed from the blood vessel lumen in a second introducer catheter removal step of removing the introducer catheter 126 from the patient.

[0065] With respect to advancing the RICC 102 over the introducer catheter 126 into the blood vessel lumen in the RICC advancement step until the distal end of the RICC 102 passes through the distal end of the introducer catheter 126, but is not pushed out of the introducer catheter, the method may also include a first introducer catheter removal step thereafter removing the introducer catheter 126 from the RICC 102 through a side opening 114 that penetrates the side of the catheter tube 104. Again, once the introducer catheter 126 has been removed from the RICC 102 through the side opening 114 of the catheter tube 104, the introducer catheter 126 may be completely removed from the blood vessel lumen in a second introducer catheter removal step that removes the introducer catheter 126 from the patient.

[0066] However, a first introducer catheter removal step is not necessary with respect to advancing the RICC 102 on the introducer catheter 126 into the vascular lumen until the RICC 102 is pushed out of the introducer catheter 126. In fact, advancing the RICC 102 on the introducer catheter into the vascular lumen until the RICC 102 is pushed out of the introducer catheter simultaneously removes the introducer catheter 126 from the RICC 102 through the side opening 114 that penetrates the side of the catheter tube 104. Again, once the introducer catheter 126 has been removed from the RICC 102 through the side opening 114 of the catheter tube 104, the introducer catheter 126 may be completely removed from the vascular lumen in a second introducer catheter removal step that removes the introducer catheter 126 from the patient.

[0067] The method may further include a steering guidewire advancement step, for example, advancing a steering guidewire into the lumen of a blood vessel via a distal lumen opening at the distal end of the RICC 102. The steering guidewire may be used to further advance the RICC 102 into the blood vessel, such as the lower third of the superior vena cava (SVC) of the heart, before being removed. As described above, the introducer lumen 110, which extends from the distal end of the catheter tube 104 through the distal end or tip 112 of the catheter tube 104, is configured to accommodate an introducer needle, introducer catheter, or introducer combination. If that portion of the introducer lumen 110 includes an introducer needle, introducer catheter, or introducer combination, the introducer needle, introducer catheter, or introducer combination must be removed prior to the steering guidewire advancement step to ensure that the introducer lumen 110 is free of the introducer needle, introducer catheter, or introducer combination.

[0068] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional improvements and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these improvements and / or modifications as well. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein. The technical ideas that can be understood from the above-described embodiment will be described below as supplementary notes. [Appendix 1] A rapidly insertable central catheter (RICC), A catheter tube comprising: an introduction lumen among the catheter tube lumens, the introduction lumen extending from a proximal end of the catheter tube to a distal end of the catheter tube; Several lumen openings; a side opening proximal to the several lumen openings, the side opening extending through the side of the catheter tube and opening into the introducer lumen at the distal end of the catheter tube; a separately formed catheter tip attached to the distal end of the catheter tube, the catheter tube configured to receive an introducer needle, an introducer catheter, or a combination thereof, through the side opening, along the distal end of the catheter tube within the introducer lumen, and through the distal end of the catheter tube for introducing the RICC into a patient's vasculature; a hub attached to a proximal end of the catheter tube, the hub including a number of hub lumens equal to the number of the catheter tube lumens; a number of extension legs extending from the hub, the number of extension legs being equal to the number of catheter tube lumens, each extension leg including an extension leg lumen. [Appendix 2] 2. The RICC of claim 1, wherein the side opening is configured to seal when the introducer needle, the introducer catheter, or the combination thereof is removed from the RICC. [Appendix 3] 3. The RICC of claim 2, wherein the side opening is a perforation established by the introducer needle, the introducer catheter, or the combination thereof, and the catheter tube at least around the perforation is formed from an elastomeric material configured to return to its default state when the introducer needle, the introducer catheter, or the combination thereof is removed from the perforation, thereby sealing the perforation. [Appendix 4] 3. The RICC of claim 2, wherein the catheter tube includes a flap covering and / or extending into the side opening that is configured to be held open by the introducer needle, the introducer catheter, or the combination thereof and to return to its default state when the introducer needle, the introducer catheter, or the combination thereof is removed from the side opening, thereby sealing the side opening. [Appendix 5] 5. The RICC of any one of claims 1 to 4, wherein the catheter tube includes a reinforced region around the side opening configured to maintain the integrity of the catheter tube around the side opening. [Appendix 6] 6. The RICC of any one of claims 1 to 5, wherein the number of the catheter tube lumens, the number of the hub lumens, and the number of the extension leg lumens are three, and the RICC includes a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen, formed from fluidly connected portions of the catheter tube lumens, the hub lumen, and the extension leg lumens. [Appendix 7] 7. The RICC of claim 6, wherein the lumen openings are three in number, the distal lumen having a distal lumen opening at a distal end of the RICC, the middle lumen having a middle lumen opening on the side of the catheter tube distal to the side opening, and the proximal lumen having a proximal lumen opening on the side of the catheter tube distal to the side opening but proximal to the middle lumen opening.

Claims

1. 1. A catheter assembly comprising: An introducer catheter; an introducer needle disposed within the introducer-catheter lumen of the introducer catheter to form an introducer combination; A rapidly insertable central catheter (RICC), comprising: A catheter tube comprising: an introduction lumen among the catheter tube lumens, the introduction lumen extending from a proximal end of the catheter tube to a distal end of the catheter tube; Several lumen openings; a side opening proximal to the several lumen openings, the side opening extending through the side of the catheter tube and opening into the introducer lumen at the distal end of the catheter tube; and a catheter tube including a separately formed catheter tip attached to the distal end of the catheter tube, the introducer combination being positioned through the side opening, along the distal end of the catheter tube within the introducer lumen, and through the distal end of the catheter tube to introduce the RICC into a patient's vasculature.

2. 10. The catheter assembly of claim 1, further comprising a syringe including a tip extending from a barrel of the syringe, the tip configured as a Luer connector for connecting to a hub of the introducer needle configured as a complementary Luer connector.

3. The catheter assembly of claim 1 or 2, wherein the side opening is configured to seal when the introducer catheter is removed from the RICC.

4. 4. The catheter assembly of claim 3, wherein the side opening is a perforation established by the introducer needle, and the catheter tube at least about the periphery of the perforation is formed from an elastomeric material configured to return to its default state when the introducer catheter is removed from the perforation, thereby sealing the perforation.

5. 4. The catheter assembly of claim 3, wherein the catheter tube includes a flap covering and / or extending into the side opening that is held open by the introducer catheter and configured to return to its default state when the introducer catheter is removed from the side opening, thereby sealing the side opening.

6. 6. The catheter assembly of claim 1, wherein the catheter tube includes a reinforced region around the side opening configured to maintain the integrity of the catheter tube around the side opening.

7. Said RICC further: a hub attached to a proximal end of the catheter tube, the hub including a number of hub lumens equal to the number of the catheter tube lumens; 7. The catheter assembly of claim 1, further comprising: a number of extension legs extending from the hub, the number of extension legs being equal to the number of catheter tube lumens, each extension leg including an extension leg lumen.

8. 8. The catheter assembly of claim 7, wherein the number of the catheter tube lumens, the number of the hub lumens, and the number of the extension leg lumens are three, and the RICC includes a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen, formed from fluidly connected portions of the catheter tube lumens, the hub lumen, and the extension leg lumens.

9. 9. The catheter assembly of claim 8, wherein the number of lumen openings is three, the distal lumen has a distal lumen opening at a distal end of the RICC, the middle lumen has a middle lumen opening on the side of the catheter tube distal to the side opening, and the proximal lumen has a proximal lumen opening on the side of the catheter tube distal to the side opening but proximal to the middle lumen opening.

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