KR-102964829-B1 - Rapidly insertable central catheters including catheter assemblies and methods thereof

KR102964829B1KR 102964829 B1KR102964829 B1KR 102964829B1KR-102964829-B1

Abstract

A rapid-insertable central catheter (“RICC”) comprising a catheter assembly and a method thereof are disclosed. The catheter assembly may comprise an introductory catheter, an introductory needle, and an RICC. The introductory needle may be positioned within the introductory-catheter lumen of the introductory catheter forming an introductory assembly. The RICC may comprise a catheter tube comprising an introductory lumen having a plurality of lumens and a lateral opening through the side of the catheter tube. The introductory lumen extends from the proximal end of the catheter tube to the distal end of the catheter tube. The lateral opening opens into the introductory lumen at the distal end portion of the catheter tube. The introductory assembly may be positioned through the lateral opening along the distal end portion of the catheter tube within the introductory lumen and through the distal end of the catheter tube to introduce the RICC into a patient's blood vessel.

Inventors

호웰, 글레이드, 에이치.

Assignees

바드 액세스 시스템즈, 인크.

Dates

Publication Date: 20260513
Application Date: 20210419
Priority Date: 20200420

Claims (16)

As a rapidly insertable central catheter ("RICC") including a catheter tube, The above catheter tube is, An induction lumen composed of multiple catheter tube lumens - said induction lumen extends from the proximal end of said catheter tube to the distal end of said catheter tube - ; Multiple lumen openings; A self-sealing side opening adjacent to the plurality of lumen openings above—the side opening passes through the side of the catheter tube that opens into the introduction lumen within the distal-end portion of the catheter tube, and the side opening is sealed when an introduction needle, introduction catheter, or a combination of the same is removed from the RICC through the side opening—; and A separately formed catheter tip coupled to the distal end of the catheter tube—the catheter tube is configured to receive the introducer needle, the introducer catheter, or the introducer combination through the side opening and through the distal end of the catheter tube along the distal end portion of the catheter tube within the introduction lumen in order to introduce the rapid-insertable central catheter into the patient's blood vessel—; Includes, and The above-mentioned rapid-insertable central catheter is, A hub coupled to a proximal end portion of the catheter tube, comprising a number of hub lumens equal to the number of catheter tube lumens; and A plurality of extension legs extending from the above hub, with a number equal to the number of catheter tube lumens—each of the plurality of extension legs includes an extension-leg lumen—; including, Rapidly insertable central catheter.
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In paragraph 1, The above-mentioned side opening is, A perforation formed by the above-mentioned introductory needle, the above-mentioned introductory catheter, or the above-mentioned introductory combination, and At least the catheter tube around the perforation site, Formed of an elastomeric material configured to return to a default state when the introductory needle, the introductory catheter, or the introductory combination is removed from the perforation to seal the perforation, Rapidly insertable central catheter.
In paragraph 1, The above catheter tube is, A flap configured to be positioned above the side opening, extend into the side opening, or be kept open by the introductory needle, the introductory catheter, or the introductory assembly, and configured to return to a default state when the introductory needle, the introductory catheter, or the introductory assembly is removed from the side opening to seal the side opening; including, Rapidly insertable central catheter.
In any one of paragraphs 1, 3, and 4, The above catheter tube is, An area of reinforcement around the side opening configured to maintain the integrity of the catheter tube around the side opening; including, Rapidly insertable central catheter.
In any one of paragraphs 1, 3, and 4, The number of the catheter tube lumens, the number of the hub lumens, and the number of the extension-leg lumens are 3, and The above-mentioned rapid-insertable central catheter is, A set of three lumens comprising a proximal lumen, a central lumen, and a distal lumen formed by fluidly connected portions of the catheter tube lumen, the hub lumen, and the extension-leg lumen, Rapidly insertable central catheter.
In paragraph 6, The number of the above lumen openings is 3, and, The above distal lumen has a distal-lumen opening at the distal end of the rapid-insertable central catheter, The central lumen has a central-lumen opening on the side of the catheter tube far from the lateral opening, The above proximal lumen has a proximal lumen opening on the side of the catheter that is far from the above lateral opening but close to the above central lumen opening, Rapidly insertable central catheter.
As a catheter assembly, Introductory catheter; An introducer needle disposed within the introducer-catheter lumen of an introducer catheter forming an introducer assembly; and Rapidly Insertable Central Catheter ("RICC") containing a catheter tube Includes, and, The above catheter tube is, An induction lumen composed of multiple catheter tube lumens - said induction lumen extends from the proximal end of said catheter tube to the distal end of said catheter tube - ; Multiple lumen openings; A side opening adjacent to the plurality of lumen openings above—the side opening passes through the side of the catheter tube that opens into the introduction lumen within the distal-end portion of the catheter tube—; and A separately formed catheter tip coupled to the distal end of the catheter tube—the introductor assembly is positioned along the distal-end portion of the catheter tube within the introduction lumen, through the side opening and through the distal end of the catheter tube, to introduce the rapid-insertable central catheter into the patient's blood vessel—; including, Catheter assembly.
In paragraph 8, A syringe including a tip extending from the body of the syringe; Includes more of, and The above tip portion is composed of a lure connector connected to the hub of the introduction hook, which is configured as a complementary lure connector. Catheter assembly.
In paragraph 8, The above-mentioned side opening is configured to be sealed when the introductory catheter is removed from the rapid-insertable central catheter. Catheter assembly.
In Paragraph 10, The above-mentioned side opening is a perforation formed by the above-mentioned introductory needle, and At least the catheter tube around the perforation site, Formed of an elastomeric material configured to return to a default state when the introductory catheter is removed from the perforation to seal the perforation, Catheter assembly.
In Paragraph 10, The above catheter tube is, A flap configured to be positioned above the side opening, extend into the side opening, or be kept open by the introductory catheter, and configured to return to a default state when the introductory catheter is removed from the side opening to seal the side opening; including, Catheter assembly.
In any one of paragraphs 8 through 12, The above catheter tube is, An area of reinforcement around the side opening configured to maintain the integrity of the catheter tube around the side opening; including, Catheter assembly.
In any one of paragraphs 8 through 12, The above-mentioned rapid-insertable central catheter is, A hub coupled to a proximal end portion of the catheter tube, comprising a number of hub lumens equal to the number of catheter tube lumens; and A plurality of extension legs extending from the above hub, with a number equal to the number of catheter tube lumens - each of the plurality of extension legs includes an extension-leg lumen - ; including, Catheter assembly.
In Paragraph 14, The number of the catheter tube lumens, the number of the hub lumens, and the number of the extension-leg lumens are 3, and The above-mentioned rapid-insertable central catheter is, A set of three lumens comprising a proximal lumen, a central lumen, and a distal lumen formed by fluidly connected portions of the catheter tube lumen, the hub lumen, and the extension-leg lumen, Catheter assembly.
In paragraph 15, The number of the above lumen openings is 3, and, The above distal lumen has a distal-lumen opening at the distal end of the rapid-insertable central catheter, The central lumen has a central-lumen opening on the side of the catheter tube far from the lateral opening, The above proximal lumen has a proximal lumen opening on the side of the catheter that is far from the above lateral opening but close to the above central lumen opening, Catheter assembly.

Description

Rapidly insertable central catheters including catheter assemblies and methods thereof The present disclosure relates to a catheter assembly, and more specifically, to a rapidly insertable central catheter comprising catheter assemblies. Central venous catheters ("CVCs") are formed from materials with relatively low durometers, which contributes to their weak column strength. Due to this weak column strength, CVCs are typically introduced into patients and advanced through the vascular system via the Seldinger technique. The Seldinger technique involves multiple steps and medical devices (e.g., needle, scalpel, guide wire, introducer sheath, dilator, CVC, etc.). While the Seldinger technique is effective, the multiple steps make it time-consuming, and handling numerous medical devices is cumbersome; both of these factors can lead to patient trauma. Furthermore, the risk of touch contamination is relatively high due to the many medical devices that must be replaced during the various steps of the Seldinger technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing catheters, such as CVCs, into patients and advancing them through the vascular system. To solve the aforementioned problems, rapidly insertable central catheters ("RICC") are disclosed herein. A method for inserting an RICC into a patient's blood-vessel lumen is disclosed herein, and such method comprises, in some embodiments, a catheter assembly-acquisition step, a needle-establishment step, an inducer needle-removal step, an inducer catheter-advancement step, and an RICC-advancement step. The catheter assembly-acquisition step comprises acquiring a catheter assembly comprising an inducer assembly and an RICC. The inducer assembly comprises an inducer needle positioned within the inducer-catheter lumen of the inducer catheter. The RICC comprises a catheter tube, the catheter tube having a side opening through the side of the catheter tube that is open into the inducer lumen and the inducer lumen. The inducer assembly is positioned along the distal end portion of the catheter tube within the inducer lumen and through the side opening through the distal end of the catheter tube. The needle-establishment step comprises forming a needle tube with the tip of the inducer needle. The needle tube extends from the patient's skin area to the vascular lumen. The introductory needle-removal step involves removing the introductory needle from the introductory assembly and leaving the introductory catheter in place. The introductory catheter-advancement step involves advancing the introductory catheter into the vascular lumen. The RICC-advancement step involves advancing the RICC into the vascular lumen over the introductory catheter until the distal end of the RICC aligns with the distal end of the introductory catheter, until the RICC is pushed out of the introductory catheter, or until the distal end of the RICC passes the distal end of the introductory catheter but is not pushed out of the introductory catheter. In some embodiments, the method further includes an introducer combination-placement step of placing the introducer combination within a side opening of a catheter tube. In some embodiments, the method further comprises an inducer assembly-adjustment step and a needle tip-ensuring step. The inducer assembly-adjustment step comprises adjusting the inducer assembly such that at least about 1 to 7 cm of the inducer assembly extends from the distal end of the RICC. The needle tip-ensuring step comprises ensuring that the tip of the inducer needle extends past the distal end of the inducer catheter before forming a needle tube. In some embodiments, the method further comprises a blood-aspiration step of aspirating blood with a syringe fluidically connected to an inducer needle. The blood-aspiration step ensures that the tip of the inducer needle is positioned within the vascular lumen before removing the inducer needle from the inducer assembly. In some embodiments, the introductory catheter-advancement step comprises advancing the introductory catheter into the vascular lumen by at least about 1 to 7 cm. Advancing the introductory catheter into the vascular lumen by about 1 to 7 cm ensures that the introductory catheter is sufficiently positioned into the vascular lumen before the RICC-advancement step. In some embodiments, the RICC is advanced into the vascular lumen over the introductory catheter during the RICC-advancement phase until the distal end of the RICC coincides with the distal end of the introductory catheter or until the distal end of the RICC passes the distal end of the introductory catheter but is not pushed out of the introductory catheter. In some embodiments, the method further includes an introductory catheter removal step of removing the introductory catheter from the RICC through a lateral opening through the side of the catheter tube. In an embodiment, during the RICC-advancement st