KR-102964820-B1 - Two-piece rapid-insertable central catheters, introducers therefor, and methods therefor

KR102964820B1KR 102964820 B1KR102964820 B1KR 102964820B1KR-102964820-B1

Abstract

A 2-piece rapid-insertable central catheter (“RICC”), an inducer, and a method are disclosed. For example, the distal catheter piece of the RICC and the inducer may be coupled in an inducer assembly configured to be operated by one finger of the same hand while the inducer is held between the thumb and other fingers or fingers of the hand. The catheter-advancing hub of the inducer comprises a manifold coupled to the proximal portion of the distal catheter-hub piece of the distal catheter piece. The inducer needle of the syringe of the inducer comprises a needle shaft extending through the manifold and the distal end of the distal catheter piece. An inducer housing is positioned over the syringe tip, the manifold, and the proximal portion of the distal catheter piece. The inducer housing of the inducer is configured to provide column strength to the catheter tube of the distal catheter piece during venipuncture.

Inventors

호웰, 글레이드 에이치.
스타츠, 제이슨 알.

Assignees

바드 액세스 시스템즈, 인크.

Dates

Publication Date: 20260513
Application Date: 20210730
Priority Date: 20200731

Claims (20)

As a rapidly insertable central catheter (RICC) system, Distal catheter-hub piece of a 2-piece catheter hub; and A catheter tube comprising one or more catheter-tube lumens — said catheter tube is coupled to said distal catheter-hub piece by a proximal portion of said catheter tube —; A distal catheter piece of the RICC comprising; and Introduction; Includes, The above-mentioned introducer is configured to be coupled with the distal catheter piece in an introducer assembly having a ready-to-deploy state, wherein the introducer is configured to be operated by a single finger of the hand while being held between the thumb and other fingers or fingers of the hand. The above-mentioned introductory device is, A catheter-advancement hub comprising a manifold and a lateral arm, and coupled to the proximal portion of the distal catheter-hub piece in the deployment-ready state of the introductory assembly; Introducer needle having a needle shaft extending through the distal end of the distal catheter piece and the manifold in the deployment preparation state of the introducer assembly; A syringe comprising a barrel having a distal portion terminating at a syringe tip and fluidly coupled to the introductory needle; and Introducer housing extending across the syringe tip, the manifold, and the proximal portion of the distal catheter piece in the deployment preparation state of the above-mentioned introducer assembly; Includes, The above-mentioned introductory housing is, Providing column strength to the catheter tube while performing venipuncture on the patient with the above-mentioned introductory needle, and Served to be divided longitudinally so as to allow the distal catheter piece to be removed from the introductory housing after the venous puncture, RICC system.
In paragraph 1, The above-mentioned introductory housing is, A lock at a distal portion of the introductory housing comprising a hook of a slidable piece of the introductory housing and a latch of a stationary piece of the introductory housing—the hook and the latch are configured to lock the slidable piece and the stationary piece together in a state ready for deployment of the introductory assembly—; including, RICC system.
In paragraph 2, The fixed piece of the above-described introductory housing comprises a channel—the channel comprises a latch in a proximal portion of the channel and a ramp in a distal portion of the channel—and the combination of the hook and the ramp is configured to push the slidable piece of the above-described introductory housing away from the fixed piece when the distal surface of the hook engages with the proximal surface of the ramp while advancing the slidable piece distally relative to the fixed piece. RICC system.
In paragraph 2 or 3, The above-mentioned introductory housing includes a sliding hinge in a proximal portion of the introductory housing, comprising a captive tab of the slideable piece of the introductory housing and a track of the fixed piece of the introductory housing, and The above-mentioned captive tab is positioned captively but slidably within the track so that the slidable piece can advance distally relative to the fixed piece without separating the slidable piece from the fixed piece at the proximal portion of the introductory housing. RICC system.
In paragraph 4, The proximal portion of the captive tab located inside the outer surface of the introductor housing is radiated to facilitate the separation of the slideable piece of the introductor housing from the fixed piece of the introductor housing at the distal portion of the introductor housing. RICC system.
In paragraph 5, The proximal portion of the introductory housing comprises a longitudinal cutout configured to provide a path to the side arm of the catheter-advancement hub while advancing the catheter-advancement hub distally within the introductory housing. RICC system.
In any one of paragraphs 1 through 3, The above manifold comprises one or more manifold lumens having the same number as the one or more catheter-tube lumens, and the one or more manifold lumens are fluidly connected to the one or more catheter-tube lumens in a ready-to-development state of the introductory assembly. RICC system.
In Paragraph 7, The side arm of the catheter-advancing hub comprises a side-arm lumen fluidly coupled to the one or more manifold lumens to simultaneously prime each lumen of the one or more catheter-tube lumens before inserting the catheter tube into the patient's vascular lumen. RICC system.
In any one of paragraphs 1 through 3, The catheter-advancement hub is configured to advance the catheter-advancement hub distally with a single finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and other fingers or fingers of the hand, and further comprises a catheter-advancement push tab extending from the side arm. RICC system.
In any one of paragraphs 1 through 3, The above RICC further includes a proximal catheter piece, and The above proximal catheter piece is, The proximal catheter-hub piece of the above 2-piece catheter hub, and One or more extension legs, each containing one or more extension-leg lumens Includes, Each of the one or more extension legs is coupled to the proximal catheter-hub piece by the distal portion of the extension leg, and The RICC has a connected state in which the proximal catheter-hub piece is connected to the distal catheter-hub piece such that the one or more extension-leg lumens are each fluidly coupled to the one or more catheter-tube lumens across the 2-piece catheter hub. RICC system.
In Paragraph 10, The above RICC includes a set of three lumens in the connection state of the above RICC, and the set of three lumens includes a primary lumen, a secondary lumen, and a tertiary lumen, RICC system.
In Paragraph 11, The primary lumen has a primary lumen aperture at the distal end of the 2-piece catheter, the secondary lumen has a secondary lumen aperture on the side of the catheter tube proximal to the primary lumen aperture, and the tertiary lumen has a tertiary lumen aperture on the side of the catheter tube proximal to the secondary lumen aperture. RICC system.
In any one of paragraphs 1 through 3, The above catheter tube is, A first section formed of a first material having a first durometer, and A second section formed of a second material having a second durometer smaller than the first durometer. By including more, The above catheter tube is configured to have both column strength for inserting the catheter tube into a patient and compliance for advancing the catheter tube through the patient's vascular structure. RICC system.
In any one of paragraphs 1 through 3, The above-mentioned introductory device further comprises a syringe housing around the barrel of the syringe having a distal portion and a proximal portion, wherein the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger disposed in the barrel such that the plunger is withdrawn from the barrel when the syringe housing is slid proximally relative to the barrel. RICC system.
In Paragraph 14, The above syringe further includes a plunger-withdrawal push tab, and The plunger-withdrawal push tab extends proximally over the barrel from the distal portion of the barrel to which the plunger-withdrawal push tab is coupled, and The plunger-withdrawal push tab is configured to slide the syringe housing proximally relative to the barrel by pushing with the single finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and other fingers or fingers of the hand, and to withdraw the plunger from the barrel. RICC system.
In Paragraph 14, The above-described introductory device further comprises an access guidewire disposed in an access-guidewire lumen formed by at least the plunger lumen of the plunger and the needle lumen of the introductory device needle, and The access guidewire has a length sufficient for the access guidewire to extend through the distal end of the distal catheter piece. RICC system.
In Paragraph 16, The above-mentioned introductory device is, It further includes a slider that extends distally from the syringe housing over the barrel and is configured to operate the access guide wire with the single finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and other fingers or fingers of the hand. The slider includes an extension extending into the access-guidewire lumen through the longitudinal slots of the barrel and the plunger, respectively, and the extension is coupled to the access guidewire. RICC system.
As an introductory device for a rapid insertable central catheter ("RICC"), A catheter-advancement hub comprising a manifold and a side arm, configured to be coupled to the distal catheter piece of the RICC in an introducer assembly; Introducer needle having a needle shaft configured to extend through the distal end of the distal catheter piece and the manifold in the ready-to-deploy state of the introducer assembly; A syringe comprising a barrel having a distal portion that is fluidically coupled to the introductor needle and terminates at a syringe tip, and configured to be held around the distal portion of the barrel between the thumb and other fingers or fingers of the hand, leaving a single finger to operate the introductor; and Introducer housing extending across the syringe tip, the manifold, and the proximal portion of the distal catheter piece in the deployment preparation state of the above-mentioned introducer assembly; Includes, The above-mentioned introductory housing is, Providing column strength to the catheter tube of the distal catheter piece while performing venipuncture on the patient with the above-mentioned introductory needle, and Served to be divided longitudinally so as to allow the distal catheter piece to be removed from the introductory housing after the venous puncture, Introduction period.
In Paragraph 18, The above-mentioned introductory housing is, A lock at a distal portion of the introductory housing, comprising a hook of a slidable piece of the introductory housing and a latch of a stationary piece of the introductory housing—the hook and the latch are configured to lock the slidable piece and the stationary piece together—; including, Introduction period.
In Paragraph 19, The fixed piece of the above-described introductory housing comprises a channel—the channel comprises a latch in a proximal portion of the channel and a ramp in a distal portion of the channel—and the combination of the hook and the ramp is configured to push the slidable piece of the introductory housing away from the fixed piece when the distal surface of the hook engages with the proximal surface of the ramp while advancing the slidable piece distally relative to the fixed piece. Introduction period.

Description

Two-piece rapid-insertable central catheters, introducers therefor, and methods therefor The present disclosure relates to a catheter, and more specifically to a rapidly insertable central catheter. Conventional catheters are manufactured as fully ready-to-use devices. These catheters can range in length from 30 to 40 cm when measured from the proximal to the distal end. Rapidly Insertable Central Catheters (RICCs), currently under development, can be inserted over an introducer needle. However, inserting a RICC through a 30-40 cm introducer needle can be a cumbersome task for some clinicians. Furthermore, it can be difficult to determine in a timely manner whether a blood flashback has occurred and whether access to the vascular lumen is available during the RICC insertion process using a 30-40 cm introducer needle. Therefore, RICCs generally include a distal introduction opening designed to insert the RICC over a shorter introducer needle. However, since the introduction opening effectively becomes an artifact after RICC insertion, it would be advantageous to eliminate the introduction opening. FIG. 1 shows a first perspective view of an introductory assembly including a distal catheter piece and an introductory device of a 2-piece RICC according to some embodiments. FIG. 2 shows a second perspective view of an introductory assembly according to some embodiments. FIG. 3 shows a plan view of an introductory assembly according to some embodiments. FIG. 4 shows a bottom view of an introductory assembly according to some embodiments. FIG. 5 shows a side view of an introductory assembly in an operating state in which an access guide wire is advanced through the distal end of a distal catheter piece of RICC according to some embodiments. FIG. 6 illustrates a side view of an introductory assembly in a different operational state in which the distal catheter piece and the split introductory housing of the RICC are advanced from the ready-to-develop state of the introductory assembly according to some embodiments. FIG. 7 shows a perspective view of an introductory assembly in the same operating state as FIG. 6, according to some embodiments. FIG. 8 illustrates a sliding hinge located in the proximal part of an introductory housing according to some embodiments. FIG. 9 illustrates a locking portion located in the distal part of an introductory housing according to some embodiments. FIG. 10 illustrates a syringe of an introductory device according to some embodiments. FIG. 11 illustrates a longitudinal cross-sectional view of a portion of a syringe according to some embodiments. FIG. 12 illustrates a catheter-advancing hub coupled to a distal catheter-hub piece of a distal catheter piece in a state ready for deployment of an introductory assembly according to some embodiments. FIG. 13 illustrates a 2-piece RICC in a disconnected state according to some embodiments. FIG. 14 illustrates a 2-piece RICC in a connected state according to some embodiments. FIG. 15 illustrates the proximal catheter-hub piece and the distal catheter-hub piece of a 2-piece catheter hub in a disconnected state of an RICC according to some embodiments. FIG. 16 illustrates a proximal catheter-hub piece and a distal catheter-hub piece in a connected state of an RICC according to some embodiments. FIG. 17 illustrates the distal portion of the catheter tube of FIG. 13 and 14 of the RICC according to some embodiments. FIG. 18 illustrates a first cross-sectional view of the catheter tube of FIG. 17 according to some embodiments. FIG. 19 illustrates a second cross-sectional view of the catheter tube of FIG. 17 according to some embodiments. FIG. 20 illustrates a third cross-sectional view of the catheter tube of FIG. 17 according to some embodiments. FIG. 21 illustrates a fourth or fifth cross-sectional view of the catheter tube of FIG. 17 according to some embodiments. This patent application claims the benefit of priority to U.S. provisional patent application No. 63/059,798 filed on July 31, 2020, and the aforementioned U.S. patent application is incorporated by reference into this patent application. Before specifically disclosing certain embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It will also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may be optionally combined with or substituted with features of any many other embodiments disclosed herein. With respect to the terms used herein, it should be understood that the terms are intended for the purpose of describing certain specific embodiments and 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 a sequential or numerical lim