阅读说明：本技术 包括导管组件的可快速插入的中心导管及其方法 (Rapidly insertable central catheter including catheter assembly and method thereof ) 是由 G·H·豪厄尔 J·R·斯塔斯 于 2021-05-20 设计创作，主要内容包括：公开了一种包括导管组件的可快速插入的中心导管(“RICC”)及其方法。例如,RICC组件包括RICC和导引器。RICC包括导管管件、导管衬套和按前述顺序联接的一个或多个延伸腿。导管管件包括侧孔,该侧孔通向至少从侧孔延伸至RICC的远端的导引内腔。导引器包括可伸缩针装置、注射器和联接衬套,该联接衬套在RICC组件的立即部署状态下在侧孔的近侧将可伸缩针装置与注射器联接在一起。可伸缩针装置包括导引针。当RICC组件处于RICC组件的立即部署状态时,导引针的杆部的远端部分中的针尖端延伸超出RICC的远端。(A rapidly insertable central catheter ("RICC") including a catheter assembly and methods thereof are disclosed. For example, a RICC component includes a RICC and an introducer. The RICC includes a catheter tube, a catheter hub, and one or more extension legs coupled in the aforementioned order. The catheter tubing includes a side hole leading to a guide lumen extending at least from the side hole to the distal end of the RICC. The introducer comprises a retractable needle device, a syringe, and a coupling hub that couples the retractable needle device and the syringe together proximal to the side hole in the immediate deployment state of the RICC assembly. The retractable needle device includes an introducer needle. When the RICC assembly is in its immediate deployed state, the needle tip in the distal portion of the shaft of the introducer needle extends beyond the distal end of the RICC.)

1. A rapidly insertable central catheter ("RICC") assembly, comprising:

a RICC, the RICC comprising:

a catheter tube including a first section formed of a first material having a first hardness, a second section formed of a second material having a second hardness that is less than the first hardness, and a side hole through a side of the catheter tube in a distal portion of the catheter tube but proximal to the first section of the catheter tube, the side hole leading to a guide lumen of the catheter tube extending from at least the side hole to a distal end of the RICC;

a catheter hub coupled to a proximal portion of the catheter tube; and

one or more extension legs, each of the one or more extension legs coupled to the catheter hub through a distal portion thereof;

an introducer, the introducer comprising:

a retractable needle device comprising an introducer needle having a shaft and a needle tip in a distal portion of the shaft, the needle tip extending beyond a distal end of the RICC when the RICC assembly is at least in an immediately deployed state of the RICC assembly;

an injector; and

a coupling bushing that couples the retractable needle device and the syringe together proximal to the side hole, at least in an immediate deployment state of the RICC assembly.

2. The RICC assembly of claim 1, wherein at least in an immediate deployment state of the RICC assembly, the shaft of the introducer needle extends through the longitudinal throughbore of the coupling hub, through the side bore of the catheter tubing, and along the introducer lumen of the catheter tubing.

3. The RICC assembly of claim 1, wherein the coupling hub comprises a sealed flashback chamber, a notch of the shaft of the introducer needle disposed in the flashback chamber configured to release blood into the flashback chamber when the needle tip enters a vascular lumen of a patient.

4. The RICC assembly of claim 3, wherein the coupling hub comprises a side arm extending from one side of the coupling hub, the syringe fluidly coupled to the blood flashback chamber through a side arm lumen of the side arm for aspirating blood upon entering the blood vessel lumen.

5. The RICC assembly of claim 1, wherein the introducer further comprises:

a clamp having a syringe gripping portion and a needle device gripping portion, the syringe gripping portion of the clamp configured to grip the syringe through a barrel of the syringe and the needle device gripping portion of the clamp configured to grip the retractable needle device through a body of the retractable needle device while allowing the retractable needle device to slide in the needle device gripping portion of the clamp.

6. The RICC assembly of claim 5, wherein the syringe comprises a plunger disposed in a barrel of the syringe, the plunger comprising a plunger extension configured to allow a clinician to withdraw the plunger from the barrel by pushing a tongue of the plunger extension proximally while manipulating the RICC assembly around the coupling hub.

7. The RICC assembly of claim 1, wherein the coupling bushing comprises a tab configured to allow a clinician to use a single finger of one hand to one-handed advance the RICC over the needle tip while holding the distal portion of the retractable needle device between the thumb and another finger or fingers of that hand.

8. The RICC assembly of claim 1, wherein the retractable needle device further comprises:

an access guidewire disposed in a needle lumen of the introducer needle; and

an access guidewire actuator configured to advance a distal portion of the access guidewire beyond the needle tip or to withdraw the distal portion of the access guidewire into a distal portion of the shaft of the introducer needle proximal of the needle tip.

9. The RICC assembly of claim 8, wherein the access guidewire actuator comprises a slider slidably disposed in a longitudinal slot of a housing of the retractable needle device, the slider comprising an extension coupled to a proximal portion of the access guidewire within a lumen of the retractable needle device enclosed by the housing.

10. The RICC assembly of claim 9, wherein a proximal end portion of the introducer needle is disposed in a carriage of the retractable needle device, the introducer needle actuator of the retractable needle device being configured to release a compressed compression spring around the carriage and push both the carriage and the introducer needle proximally into a lumen of the retractable needle device when actuated.

11. The RICC assembly of claim 10, wherein the carriage is configured to engage a slider of the entry guidewire actuator when the carriage is pushed proximally into the lumen of the retractable needle device, thereby withdrawing the entry guidewire into the lumen of the retractable needle device along with the guide needle through a distal end portion of the entry guidewire when the guide needle actuator is actuated.

12. The RICC assembly of claim 1, further comprising a sterile barrier over the catheter tubing between the catheter hub and the side hole of the catheter tubing, the sterile barrier configured to rupture when the sterile barrier tab is pulled away from the catheter tubing by a sterile barrier tab of a proximal portion of the sterile barrier.

13. The RICC assembly of claim 1, wherein the RICC comprises a set of three lumens, including a distal lumen, a middle lumen and a proximal lumen, formed by three catheter tube lumens, three hub lumens and three fluid connections extending the leg lumens, the guide lumen of the catheter tube coinciding with the distal portion of the distal lumen.

14. The RICC assembly of claim 13, wherein the distal lumen has a distal lumen hole in a distal end of the RICC, the middle lumen has a middle lumen hole in a side of the catheter tube proximal to the distal lumen hole, the proximal lumen has a proximal lumen hole in a side of the catheter tube proximal to the middle lumen hole, and the side hole of the catheter tube is between the distal lumen hole and the middle lumen hole, between the middle lumen hole and the proximal lumen hole, or proximal to the proximal lumen hole.

15. A method for inserting a rapidly insertable central catheter ("RICC") into a vascular lumen of a patient, comprising:

obtaining a RICC assembly comprising a RICC and an introducer of a retractable needle device and a syringe coupled together by a coupling hub, the retractable needle device comprising an introducer needle having a shaft that, at least in an immediate deployed state of the RICC assembly, extends through a longitudinal through-hole of the coupling hub, through a side hole in a distal portion of a catheter tubing of the RICC, extends along a guiding lumen of the catheter tubing, and extends beyond a distal end of the RICC;

establishing a needle track from the skin area of the patient to the vascular lumen using a needle tip of the introducer needle while holding a distal portion of the retractable needle device;

advancing the distal portion of the catheter tube into the vascular lumen over the needle tip; and

withdrawing the shaft of the introducer needle from the introducer lumen via the side hole of the catheter tube.

16. The method of claim 15, wherein establishing the needle track includes ensuring flashback of blood to a sealed blood flashback chamber of the coupling hub, a notch of a shaft of the introducer needle being disposed in the blood flashback chamber for releasing blood into the blood flashback chamber when establishing the needle track.

17. The method of claim 16, further comprising aspirating blood using the syringe prior to withdrawing the shaft of the introducer needle from the introducer lumen, thereby confirming that the needle tip is disposed in the patient's vascular lumen, the syringe fluidly coupled to the flashback chamber through a side arm lumen of a side arm of the coupling hub for aspirating blood upon entering the patient's vascular lumen.

18. The method of claim 15, wherein advancing the distal portion of the catheter tube into the vessel lumen comprises: using a single finger of one hand to advance the catheter tubing into the vascular lumen while holding the distal portion of the retractable needle device between the thumb and one or more fingers of the one hand, the coupling hub comprising a tab configured to advance the catheter tubing into the vascular lumen using the single finger.

19. The method of claim 15, further comprising advancing a distal portion of an access guidewire disposed in a needle lumen of the introducer needle into the vascular lumen prior to advancing the distal portion of the catheter tube into the vascular lumen over the needle tip, the advancing comprising sliding a slider slidably disposed in a longitudinal slot of a housing of the retractable needle device, the slider comprising an extension coupled to a proximal portion of the access guidewire disposed in a lumen of the retractable needle device surrounded by the housing.

20. The method of claim 19, wherein withdrawing the shaft of the introducer needle from the introducer lumen of the catheter tube comprises actuating an introducer needle actuator of the retractable needle device, wherein a proximal portion of the introducer needle disposed in a carriage of the retractable needle device is configured to push proximally into a lumen of the retractable needle device when a compressed compression spring around the carriage is released by the introducer needle actuator.

21. The method of claim 15, further comprising advancing a steering guidewire into the vessel lumen via a distal lumen having a distal lumen hole in a distal end of the RICC, the guide lumen of the catheter tube coinciding with a distal portion of the distal lumen, thereby requiring withdrawal of the shaft of the guide needle from the guide lumen of the catheter tube prior to advancing the steering guidewire into the vessel lumen.

22. The method of claim 15, further comprising removing the sterile barrier by breaking apart the sterile barrier by pulling a sterile barrier tab of a proximal portion of the sterile barrier disposed over the catheter tubing between a catheter hub of the RICC and a side hole of the catheter tubing away from the catheter tubing.

23. The method of claim 15, wherein the catheter tube includes a first section formed of a first material having a first hardness and a second section formed of a second material having a second hardness less than the first hardness, the second section being proximal to the first section, the first section of the catheter tube being configured with a column strength for advancing the catheter tube into the vascular lumen.

Technical Field

The present application relates to the field of medical devices, and more particularly to a rapidly insertable central catheter including a catheter assembly and methods thereof.

Background

Central venous catheters ("CVCs") are formed of materials having a relatively low durometer, which results in a lack of column strength for the CVC. 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 multiple steps and multiple medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). While the seldinger technique is effective, multiple steps are time consuming, handling multiple medical devices is cumbersome, and both can cause trauma to the patient. Furthermore, the likelihood of touch contamination is relatively high due to the need to interchange multiple medical devices during multiple steps of the seldinger technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter (such as a CVC) into a patient and advancing the catheter through the patient's vasculature.

Disclosed herein are a rapidly insertable central catheter ("RICC") including a catheter assembly and methods thereof that address the above-mentioned problems.

Disclosure of Invention

A RICC component is disclosed herein. In some embodiments, a RICC component comprises a RICC and an introducer. The RICC includes a catheter tubing, a catheter hub coupled to a proximal portion of the catheter tubing, and one or more extension legs, wherein each of the one or more extension legs is coupled to the catheter hub by a distal portion thereof. The catheter tubing includes a first section, a second section, and a side hole through one side of the catheter tubing in the distal portion of the catheter tubing but proximal to the first section of the catheter tubing. The first section of the catheter tubing is formed of a first material having a first hardness. The second section of the catheter tubing is formed of a second material having a second hardness that is less than the first hardness. The side hole opens into a guiding lumen of the catheter tubing that extends at least from the side hole to the distal end of the RICC. The introducer includes a retractable needle device, a syringe, and a coupling hub that couples the retractable needle device and the syringe together proximal to the side hole, at least in a ready-to-deploy (ready-to-deploy) state of the RICC assembly. The retractable needle device includes an introducer needle. The introducer needle has a shaft (draft) and a needle tip in a distal portion of the shaft. When the RICC assembly is at least in the immediate deployed state of the RICC assembly, the needle tip extends beyond the distal end of the RICC.

In some embodiments, at least in the immediate deployment state of the RICC assembly, the shaft of the introducer needle extends through the longitudinal through-hole of the coupling hub, through the side hole of the catheter tubing and along the introducer lumen of the catheter tubing.

In some embodiments, the coupling hub includes a sealed blood-flashback (blood-flashback) chamber. The notch of the shaft of the introducer needle is disposed in the flashback chamber. The incision is configured to release blood into the blood flashback chamber when the needle tip enters the lumen of a blood vessel of a patient.

In some embodiments, the coupling bushing includes a sidewall extending from one side of the coupling bushing. A syringe is fluidly coupled to the blood flashback chamber through a side arm lumen of the side arm for drawing blood upon entry into the vessel lumen.

In some embodiments, the introducer further comprises a clamp having a syringe clamping portion and a needle device clamping portion. The syringe-holding portion of the clamp is configured to hold a syringe through a barrel of the syringe. The needle device gripping portion of the clamp is configured to grip the retractable needle device through the body of the retractable needle device while allowing the retractable needle device to slide within the needle device gripping portion of the clamp.

In some embodiments, the syringe includes a plunger disposed in a barrel of the syringe. The plunger includes a plunger extension configured to allow a clinician to withdraw the plunger from the barrel by: the tab (tab) of the plunger extension is pushed proximally while manipulating the RICC assembly around the coupling hub.

In some embodiments, the coupling hub includes a tab configured to allow a clinician to use a single finger of one hand to manually advance the RICC over the needle tip while holding the distal portion of the retractable needle device between the thumb and another finger or fingers of that hand.

In some embodiments, the retractable needle device further comprises an access guidewire and an access guidewire actuator. An access guidewire is disposed in the needle lumen of the introducer needle. The access guidewire actuator is configured to advance a distal portion of the access guidewire beyond the needle tip. The access guidewire actuator is further configured to withdraw a distal end portion of the access guidewire into a distal end portion of the shaft of the introducer needle proximal of the needle tip.

In some embodiments, the access guidewire actuator includes a slider slidably disposed in a longitudinal slot of a housing of the retractable needle device. The slider includes an extension coupled to a proximal end portion of the access guidewire within a lumen of the retractable needle device enclosed by the housing.

In some embodiments, the proximal portion of the introducer needle is disposed in a carriage (carriage) of the retractable needle device. When actuated, the introducer needle actuator of the retractable needle device is configured to release the compressed compression spring around the carriage and push (thust) both the carriage and the introducer needle proximally into the lumen of the retractable needle device.

In some embodiments, the carriage is configured to engage a slider of the entry guidewire actuator when the carriage is pushed proximally into the lumen of the retractable needle device. When the introducer needle actuator is actuated, the access guidewire is withdrawn into the lumen of the retractable needle device along with the introducer needle by accessing the distal portion of the guidewire.

In some embodiments, the RICC further comprises a sterile barrier over the catheter tubing between the catheter hub and the side hole of the catheter tubing. The sterile barrier is configured to break apart when the sterile barrier tab is pulled away from the catheter tubing by a sterile barrier tab of a proximal portion of the sterile barrier.

In some embodiments, the RICC comprises a set of three lumens, including a distal lumen, a middle lumen, and a proximal lumen, formed by the fluid connections of the three catheter tubing lumens, the three liner lumens, and the three extension leg lumens. The guiding lumen of the catheter tube coincides with the distal end portion of the distal lumen (coincident).

In some embodiments, the distal lumen has a distal lumen hole in the distal end of the RICC. The intermediate lumen has an intermediate lumen hole in a side of the catheter tube that is proximal to the distal lumen hole. The proximal lumen has a proximal lumen hole in a side of the catheter tube that is proximal to the medial lumen hole. The side hole of the catheter tube is between the distal lumen hole and the medial lumen hole, between the medial lumen hole and the proximal lumen hole, or proximal to the proximal lumen hole.

Also disclosed herein is a method for inserting a RICC into a vascular lumen of a patient. In some embodiments, the method comprises a RICC assembly acquisition step, a needle track creation step, a RICC advancement step, and an introducer needle withdrawal step. The RICC component acquisition step comprises acquiring a RICC component. The RICC component includes a RICC and an introducer. The introducer comprises a retractable needle device and a syringe coupled together by a coupling hub. The retractable needle device comprises an introducer needle having a shaft that extends through a longitudinal through-hole of the coupling hub, through a side hole in a distal portion of a catheter tube of the RICC, along a guide lumen of the catheter tube, and beyond a distal end of the RICC, at least in an immediate deployment state of the RICC assembly. The needle track establishing step includes establishing a needle track from the skin region of the patient to the lumen of the blood vessel using the needle tip of the introducer needle while holding the distal portion of the retractable needle device. The RICC advancing step includes advancing the distal portion of the catheter tube into the vascular lumen over the needle tip. The introducer needle withdrawing step comprises withdrawing the shaft of the introducer needle from the guide lumen via the side hole of the catheter tube.

In some embodiments, the needle track establishing step includes ensuring that blood is returned into the sealed blood return chamber of the coupling hub. The notch of the shaft of the introducer needle is disposed in the flashback chamber for releasing blood into the flashback chamber upon entering the lumen of a patient's blood vessel.

In some embodiments, the method further comprises a blood aspiration step. The blood drawing step includes drawing blood using a syringe after the needle track establishing step but before the introducer needle withdrawing step. The syringe is fluidly coupled to the blood flashback chamber through a side arm lumen of a side arm of the coupling hub for a blood aspiration step. The blood aspiration step confirms that the needle tip is disposed in the lumen of the patient's blood vessel.

In some embodiments, the RICC advancing step comprises advancing the catheter tube into the vascular lumen using a single finger of one hand while holding the distal portion of the retractable needle device between the thumb and another finger or fingers of that hand. The coupling hub includes a tab configured for advancing the catheter tubing into the vascular lumen using a single finger.

In some embodiments, the method further comprises an access guidewire advancement step. The access guidewire advancing step comprises: a distal portion of an access guidewire disposed in a needle lumen of an introducer needle is advanced into a vascular lumen. The distal portion of the guidewire is advanced by sliding a slider slidably disposed in a longitudinal slot of a housing of the retractable needle device. The slider includes an extension coupled to a proximal end portion of the access guidewire disposed in a lumen enclosed by a housing of the retractable needle device. The access guidewire advancement step is performed prior to the RICC advancement step.

In some embodiments, the introducer needle withdrawal step comprises actuating an introducer needle actuator of the retractable needle device. The proximal end portion of the introducer needle is disposed in a carriage of the retractable needle device, the carriage configured to push proximally into a cavity of the retractable needle device when a compressed compression spring around the carriage is released by an introducer needle actuator.

In some embodiments, the method further comprises a steering guidewire advancement step. The steering guidewire advancing step comprises advancing a steering guidewire into the vascular lumen via a distal lumen having a distal lumen hole in a distal end of the RICC. The guiding lumen of the catheter tube coincides with the distal portion of the distal lumen, which requires that a (mangate) introducer needle withdrawal step be performed prior to the steering of the guidewire advancement step.

In some embodiments, the method further comprises a sterile barrier removal step. The sterile barrier removal step comprises removing the sterile barrier disposed over the catheter tubing between the catheter hub of the RICC and the side hole of the catheter tubing. The sterile barrier is removed by tearing the sterile barrier apart by pulling the sterile barrier tab of the proximal portion of the sterile barrier away from the catheter tubing.

In some embodiments, the catheter tubing includes a first section formed of a first material having a first hardness and a second section proximal to the first section formed of a second material having a second hardness less than the first hardness. The first section of the catheter tubing is configured with column strength for advancing the catheter tubing into a vascular lumen.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the drawings and following description that describe in greater detail specific embodiments of the concepts.

Drawings

Fig. 1 illustrates an isometric view of a RICC assembly including a RICC and an introducer, according to some embodiments.

Fig. 2 illustrates a top view of a RICC assembly according to some embodiments.

Fig. 3 illustrates a side view of a RICC assembly according to some embodiments.

Fig. 4 illustrates a longitudinal cross-section of a RICC assembly according to some embodiments.

Fig. 5 illustrates a distal portion of a catheter tubing of a RICC according to some embodiments.

Fig. 6 illustrates a first transverse cross-section of a catheter tubing according to some embodiments.

Fig. 7 illustrates a second transverse cross-section of a catheter tubing according to some embodiments.

Fig. 8 illustrates a third or fourth transverse cross-section of a catheter tubing according to some embodiments.

Fig. 9 illustrates a sterile barrier over a steering guidewire of a RICC assembly, according to some embodiments.

Fig. 10 illustrates a sterile barrier over a catheter tubing according to some embodiments.

Fig. 11 illustrates a plunger extension of a syringe of an introducer according to some embodiments.

Fig. 12 illustrates a clamp of an introducer according to some embodiments.

Detailed Description

Before disclosing in greater detail some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that particular embodiments disclosed herein may have features that may be readily separated from the particular embodiments and that may optionally be combined with or substituted for features of any of the various other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that these terminology is for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps need not occur in this order, and particular embodiments that include such features or steps need not be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back", and the like are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such tags are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

For example, reference to a "proximal," "proximal portion," or "proximal portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter includes the length of the catheter that is expected to be 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 near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may comprise the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the distal portion or end length of the catheter.

For example, reference to a "distal", "distal portion", or "distal portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be near or in a patient when the catheter is used on the patient. Likewise, for example, the "distal length" of a catheter includes the length of the catheter that is expected to be near or in a patient when the catheter is used on the patient. For example, the "distal end" of a catheter includes an end of the catheter that is intended to be near or in a patient when the catheter is used on the patient. The distal portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, or distal length of the catheter is not the tip portion or end length of the catheter.

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

As mentioned above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vasculature.

A RICC comprising a catheter assembly and methods thereof are disclosed herein that address the above-mentioned problems. However, it should be understood that RICC is but one type of catheter that can implement or otherwise incorporate the concepts provided herein. Indeed, peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like may also embody or otherwise incorporate the concepts provided herein for RICCs and their catheter assemblies and methods.

RICC assembly

Fig. 1-3 illustrate various views of a RICC assembly 100 including a RICC102 and an introducer 104, according to some embodiments. Fig. 4 illustrates a longitudinal cross-section of a RICC assembly 100 according to some embodiments. Fig. 5 illustrates a distal portion of a catheter tubing 106 of a RICC102 according to some embodiments. Fig. 6-8 illustrate various transverse cross-sections of the catheter tubing 106 according to some embodiments. Fig. 9-12 illustrate various other features of the RICC assembly 100 according to some embodiments.

As shown, in some embodiments, RICC assembly 100 includes a RICC102 and an introducer 104. RICC102 and introducer 104 are described in turn in the sections set forth below; however, in view of the interrelationship of RICC102 and introducer 104 in RICC assembly 100, there is some intersection between portions of RICC102 and introducer 104.

The RICC102 includes a catheter tube 106, a catheter hub 108, and one or more extension legs 110.

The catheter tube 106 comprises two or more parts including a catheter tip 112 in a distal part of the catheter tube 106, one or more catheter tube lumens and a side hole 114 in the distal part of the catheter tube 106 through one side of the catheter tube 106.

The two or more portions of the catheter tube 106 may be the main body of the catheter tube 106 and the catheter tip 112, which may be formed as a single extrusion of a single material or two similar materials. Alternatively, the catheter tubing 106 and the body of the catheter tip 112 may be formed as two different extrusions of two similar materials and subsequently coupled. However, fig. 5 illustrates an embodiment of the catheter tubing 106 in which the catheter tubing 106 is formed as two different extrusions of two different materials and subsequently coupled. Indeed, depending on the manner in which the first section 116 and the second section 118 of the catheter tube 106 are coupled, the catheter tube 106 includes a first section 116 (which includes the catheter tip 112), a second section 118 (which includes the side hole 114), and an optional transition portion 120 therebetween. For example, the first section 116 and the second section 118 of the catheter tubing 106 may be bonded by an elevated temperature, solvent, or adhesive such that the first section 116 and the second section 118 abut one another, or the second section 118 may be inserted into the first section 116 and bonded thereto by an elevated temperature, solvent, or adhesive, thereby forming the transition portion 120. Advantageously, the latter coupling of the second section 118 into the first section 116 facilitates the incorporation of a smooth taper into the transition portion 120, which taper is useful for expansion during methods of using the RICC assembly 100.

The first section 116 of the catheter tube 106 may be formed of a first material (e.g., a polymeric material such as polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer, while the second section 118 of the catheter tube 106 may be formed of a second material (e.g., a polymeric material such as polyvinyl chloride, polyethylene, polyurethane, or silicone) having a second durometer that is less than the first durometer. For example, each of the first section 116 and the second section 118 of the catheter tubing 106 may be made of different polyurethanes having different hardnesses. Indeed, polyurethane is advantageous in that the polyurethane section of the catheter tube 106 may be relatively rigid at room temperature, but becomes more flexible at body temperature, reducing irritation to the vessel wall and phlebitis. Polyurethane is also advantageous in that it can form thrombi less than some other polymers.

The catheter tube 106 having at least a first section 116 of a first polymeric material and a second section 118 of a second polymeric material has a column strength sufficient to prevent buckling of the catheter tube 106 when the catheter tube 106 is inserted into an insertion site and advanced through the vasculature of a patient. The column strength of the catheter tube 106 is significant so that the catheter tube 106 can be quickly inserted to the insertion site and advanced through the vasculature of the patient without using the seldinger technique.

It should be understood that the first and second hardnesses may be on different scales (e.g., type a or type D), and thus the second hardness of the second polymeric material may not be numerically less than the first hardness of the first polymeric material. That is, the hardness of the second polymeric material may still be less than the hardness of the first polymeric material because different scales (each scale ranging from 0 to 100) are designed to characterize different materials in a group of materials having similar hardness.

Although as previously described, the first section 116 and the second section 118 of the catheter tube 106 may be formed of the same polymeric material or different polymeric materials having substantially equal stiffness, provided that the column strength of the catheter tube 106 is sufficient to prevent buckling of the catheter tube 106 when inserted into the needle tract of a vascular lumen and advanced through the vasculature of a patient.

The one or more catheter tubing lumens may extend through the entire catheter tubing 106; however, in a multi-lumen RICC (e.g., a dual lumen RICC, a three lumen RICC, a four lumen RICC, a five lumen RICC, a six lumen RICC, etc.), typically only one catheter tube lumen extends from the proximal end of the catheter tube 106 to the distal end of the catheter tube 106. In practice, the catheter tip 112 typically includes a single lumen therethrough. Alternatively, the single lumen through the catheter tip 112 may be referred to as a "tip lumen" (particularly with reference to the first section 116 of the catheter tube 106), which is formed separately from and coupled to the remainder of the catheter tube 106.

Again, the side hole 114 passes through a side of the catheter tubing 106 in the distal part of the catheter tubing 106; however, the side hole 114 is proximal to the first section 116 of the catheter tubing 106. The side hole 114 opens into a guide lumen 122 of one or more catheter tubing lumens. The guide lumen 122 extends at least from the side hole 114 in the second section 118 of the catheter tube 106, extends through the first section 116 of the catheter tube 106 distal to the side hole 114, and extends to the distal end of the RICC102 (e.g., the distal end of the distal catheter tube 106 or the distal end of the catheter tip 112). The guide lumen 122 coincides with the distal portion of the one catheter tube lumen that generally extends from the proximal end of the catheter tube 106 to the distal end of the catheter tube 106 (particularly the distal portion of the catheter tube lumen that is distal to the side hole 114 as previously described).

The catheter hub 108 is coupled to the proximal portion of the catheter tubing 106. The catheter hub 108 includes one or more catheter hub lumens, the number of which corresponds to the one or more catheter tubing lumens. The one or more catheter hub lumens extend from the proximal end of the catheter hub 108 through the entire catheter hub 108 to the distal end of the catheter hub 108.

Each of the one or more extension legs 110 is coupled to the catheter hub 108 by a distal portion thereof. The one or more extension legs 110 each include one or more extension leg lumens, which in turn correspond in number to the one or more catheter tube lumens. Each of the one or more extension leg lumens extends from the proximal end of the extension leg through the entire extension leg to the distal end of the extension leg.

Each of the one or more extension legs 110 typically includes a luer connector coupled to the extension leg through which the extension leg and its extension leg lumen may be connected to another medical device.

Although RICC102 can be a single-lumen or multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), RICC102 shown in fig. 1-8 is three-lumen, including groups of three lumens. The set of three lumens includes, for example, a distal lumen 124, a middle lumen 126, and a proximal lumen 128, the three lumens being formed by the fluid connections of the three catheter tubing lumens, the three liner lumens, and the three extension leg lumens. Whether RICC102 is single-lumen or multi-lumen, RICC102 includes at least a distal lumen 124. The distal lumen 124 includes at least the one catheter tube lumen described above, which generally extends from the proximal end of the catheter tube 106 to the distal end of the catheter tube 106, the catheter tube lumen portion that serves as the distal lumen 124, and the fluidly connected hub lumen portion and extension leg lumen portion of the distal lumen 124. According to the aforementioned catheter tubing lumen, the guide lumen 122 of the catheter tubing 106 coincides with a distal end portion of the distal lumen 124, in particular with a distal end portion of the distal lumen 124 distal to the side hole 114.

Further to the three-lumen embodiment of RICC102, distal lumen 124 has a distal lumen hole 130 in the distal end of RICC102 (e.g., the distal end of catheter tubing 106 or the distal end of catheter tip 112). The intermediate lumen 126 has an intermediate lumen hole 132 in a side of the catheter tube 106 proximal to the distal lumen hole 130 and distal to the next proximal lumen hole, such that the intermediate lumen 126 is between the distal lumen hole 130 and the proximal lumen hole. The proximal lumen 128 has a proximal lumen hole 134 in a side of the catheter tube 106 proximal of the medial lumen hole 132. The side aperture 114 of the catheter tubing 106 may be between the distal lumen aperture 130 and the medial lumen aperture 132, between the medial lumen aperture 132 and the proximal lumen aperture 134, or proximal of the proximal lumen aperture 134 as shown in fig. 5, such that each of the distal lumen aperture 130, the medial lumen aperture 132, and the proximal lumen aperture 134 is distal of the side aperture 114.

RICC102 can further include steering guidewire 136. Although not shown, steering guidewire 136 may include an atraumatic tip (e.g., a coiled or partially coiled tip) and a length of inferior 1/3 sufficient for advancing steering guidewire 136 to the superior vena cava ("SVC") of the heart. In at least the immediate deployment state of RICC assembly 100, steering guidewire 136 can be captively disposed in RICC 102. For example, the steering guidewire 136 may be disposed in the distal lumen 124 of the RICC102 with a proximal or intermediate portion of the steering guidewire 136 disposed in the extension leg lumen portion of the distal lumen 124, an intermediate or distal portion of the steering guidewire 136 disposed in the liner lumen portion of the distal lumen 124, and a distal portion of the steering guidewire 136 disposed in the catheter tube lumen portion of the distal lumen 124 (which is formed by one of the catheter tube lumens described above that generally extends from the proximal end of the catheter tube 106 to the distal end of the catheter tube 106). However, the distal portion of the aforementioned catheter tubing lumen distal to the side hole 114 coincides with a guide lumen 122 that is occupied by a guide needle 146 at least in the immediate deployment state of the RICC assembly 100, as described below. Due to the presence of the introducer needle 146 in the introducer lumen 122, the distal end of the steering guidewire 136 does not just reach the side hole 114, at least in the immediate deployment state of the RICC assembly 100.

Steering wire 136 can include a stop 138 (e.g., a bushing, ball, slug, etc.) surrounding a proximal portion of steering wire 136, thereby forming a stop end (e.g., a bushing end, a ball end, a slug end, etc.) of steering wire 136. The blocking end of steering guidewire 136 is larger than the proximal end opening of distal lumen 124 or the portion of its extending leg lumen, thereby providing a distal restriction to advancement of steering guidewire 136 into RICC 102. In addition, the steering guidewire 136 may be arranged in a sterile barrier 188 (e.g., a longitudinal bag) of fixed length, the sterile barrier 188 including a closed or sealed proximal end and an additional open distal end removably coupled (e.g., removably adhered) to the proximal end of the luer connector of the extension leg, so as to manually remove both the sterile barrier and the steering guidewire 136 when desired. The combination of the fixed length sterile barrier, the closed or sealed proximal end of the sterile barrier, and the distal end of the sterile barrier coupled with the luer connector provides a constrained track within which steering guidewire 136 may move proximally, thereby providing a proximal constraint for withdrawal of steering guidewire 136 from RICC 102. The proximal restraint retains the atraumatic tip of steering guidewire 136 in distal lumen 124, wherein at least in embodiments of the atraumatic tip having a coiled or partially coiled tip, the atraumatic tip is maintained in a straightened or uncoiled state, e.g., as discussed in U.S. patent publication No. 2015/0038943 and U.S. patent publication No. 2016/0015943, each of which is incorporated by reference herein in its entirety. This is advantageous because reinserting such a guidewire into the lumen of a medical device, such as a catheter, is particularly difficult.

Optionally, the blocking end of steering guidewire 136 is coupled (e.g., adhered) to the proximal end of the sterile barrier to maintain the blocking end of steering guidewire 136 at the proximal end of the sterile barrier, thereby reducing the mismatch between the length of the proximal portion of steering guidewire 136 extending beyond the proximal end of RICC102 (e.g., the proximal end of a luer connector) and the unpeeled length of the sterile barrier. Reducing the mismatch between the aforementioned lengths reduces the likelihood of losing the blocked end of steering guidewire 136 in the middle portion of the sterile barrier, which may require time and effort (which would be better spent on the patient) to be rematched.

In addition to providing proximal restrictions for withdrawal of the steering guidewire from the RICC102, the sterility barrier is also configured to maintain sterility of the steering guidewire 136 prior to use of the RICC assembly 100 (e.g., transport and handling, storage, etc.) and during use of the RICC assembly 100. During use of the RICC assembly 100, the sterile barrier is configured to provide a non-contact advancement means for advancing the steering guidewire 136 into the patient's vascular lumen while establishing a needle track to the patient's vascular lumen. As such, the sterile barrier is configured to provide a non-contact withdrawal means for withdrawing the steering guidewire 136 from the vascular lumen of the patient, e.g., after the catheter tube 106 has been advanced over the steering guidewire 136.

Although not shown, the RICC102 can further include a stiffening stylet, such as a stylet in either or both of the middle lumen 126 or proximal lumen 128 of the three-lumen embodiment of the RICC102, to stiffen the RICC102, providing additional column strength to prevent buckling of the catheter tubing 106 when the catheter tubing 106 is inserted into the insertion site and advanced through the patient's vasculature.

The RICC102 can further include a sterility barrier 190 (e.g., bag, housing, etc.) configured to maintain sterility of the catheter tubing 106 between the catheter hub 108 and the side hole 114 of the catheter tubing 106 prior to inserting the catheter tubing 106 into the vascular lumen of the patient. When present, the sterile barrier 190 covers the catheter tubing 106 between the catheter hub 108 and the side bore 114 of the catheter tubing 106, at least in the immediate deployment state of the RICC assembly 100. The sterile barrier 190 is configured to split when the sterile barrier tab 192 of the proximal portion of the sterile barrier 190 is pulled apart from the catheter tubing 106, thereby providing a non-contact mechanism for removing the sterile barrier 190 from the catheter tubing 106.

Introducer 104 includes a safety needle device, such as a retractable needle device 140, a syringe 142, and a coupling hub 144 configured to couple retractable needle device 140 and syringe 142 together. Except for the distal portion of the introducer needle 146, such as described below, the introducer 104 is proximal to the side hole 114 of the catheter tubing 106 in at least the immediate deployment state of the RICC assembly 100 shown in fig. 4.

The safety needle device is configured to ensure that the clinician is safe from injury (e.g., inadvertent needle sticks), contamination, or both while using the RICC assembly 100. For example, the retractable needle device 140 includes an introducer needle 146, an introducer needle actuation mechanism configured to retract the introducer needle 146, an access guidewire 148, and an access guidewire actuation mechanism configured to advance or retract the access guidewire 148. Introducer needle actuation mechanism to retract introducer needle 146 to prevent injuryAnd withdrawing the access guidewire 148 to prevent contamination is an example of an AccuCath Ace^TMIntravascular catheter systems (Becton, Dickinson and Company (BD), franklin lake, new jersey) are disclosed in various aspects in U.S. patent No. 8,728,035, U.S. patent No. 9,162,037, and U.S. patent No. 10,220,191, each of which is incorporated by reference herein in its entirety. The safety needle device may alternatively be based onMidline catheter products such as PowerGlide PRO^TMThe design principles of midline catheters (BD, franklin lake, new jersey), aspects of which are disclosed in U.S. patent No. 8,721,546, U.S. patent No. 8,932,258, U.S. patent No. 8,986,227, U.S. patent No. 8,998,852, U.S. patent No. 9,757,540, U.S. patent No. 9,872,971, U.S. patent No. 9,950,139, U.S. patent No. 10,086,171, U.S. patent No. 10,384,039, and U.S. patent No. 10,426,931, each of which is incorporated by reference in its entirety.

The introducer needle 146 has a shaft, a needle lumen along the length of the shaft, a cutout 149 on the side of the shaft that opens into the needle lumen, and a needle tip 150 (e.g., a beveled needle tip) in a distal portion of the shaft. At least in the immediate deployment state of the RICC assembly 100, the proximal portion of the shaft including the notch 149 is disposed in the blood flashback chamber 182 of the coupling hub 144, described below, while the distal portion of the shaft extends through the longitudinal throughbore of the coupling hub 144, described below, through the side bore 114 of the catheter tubing 106, and along the guide lumen 122 of the catheter tubing 106 in the immediate deployment state of the RICC assembly 100. When the RICC assembly 100 is at least in the immediate deployed state of the RICC assembly 100, the needle tip 150 extends beyond the distal end of the RICC 102.

The introducer needle actuation mechanism includes an introducer needle actuator 152 and a carriage 154, the carriage 154 being disposed in a cavity 156 enclosed or otherwise defined by a housing 158 formed by the body of the retractable needle device 140. A proximal portion of the introducer needle 146 (e.g., a proximal portion of the shaft) is also disposed in the carriage 154. The carriage 154 may be spring loaded with a compressed compression spring 160 around the carriage 154, wherein the compression spring 160 is compressed between a proximal flange 162 of the carriage 154 and a distal end of the retractable needle device 140 (e.g., a distal wall of the housing 158), at least in an immediate deployment state of the RICC assembly 100. The introducer needle actuator 152 may include a catch 164 configured to retain the spring-loaded carriage 154 via a complementary recess 166 in a coupling bushing connection portion of the carriage 154 that extends through the distal end of the retractable needle device 140 or its housing 158. When the previously described introducer needle actuator 152 is toggled, such as by button 168 of introducer needle actuator 152, the introducer needle actuator 152 moves catch 164 out of recess 166 in the coupling bushing connection portion of carriage 154, thereby releasing spring-loaded carriage 154 and compression spring 160 thereabout. Releasing the spring-loaded carriage 154 allows the compressed compression spring 160 to relax, which allows the potential energy stored by the compressed compression spring 160 to be released. When relaxed, the compression spring 160 extends proximally and pushes both the carriage 154 and the introducer needle 146 into the cavity 156 of the retractable needle device 140.

The access guidewire 148 is captively disposed in the combination of the lumen 156 of the retractable needle device 140 and the needle lumen of the introducer needle 146. At least in the immediate deployment state of the RICC assembly 100, a proximal portion of the access guidewire 148 is disposed in the cavity 156, while a distal portion of the access guidewire 148 is disposed in the needle lumen. Advantageously, during most, if not all, of the plurality of operating states of the RICC assembly 100, most of the access guidewire 148 is contained within the retractable needle device 140. The inclusion of the access guidewire 148 within the retractable needle device 140 also includes within the retractable needle device 140 any blood or other bodily fluids that may be generated as a result of withdrawing the access guidewire 148 from the patient's vascular lumen. This minimizes or prevents the possibility of blood or other bodily fluids contaminating the surgical field or any clinician operating within the surgical field.

The access guidewire actuation mechanism includes an access guidewire actuator 170 coupled to a proximal portion of the access guidewire 148 disposed within the housing 158 of the retractable needle device 140. For example, the access guidewire actuator 170 includes a slider 172, the slider 172 being slidably disposed in a closed-end longitudinal slot of the housing 158 of the retractable needle device 140, the closed end of the longitudinal slot providing a distal stop and a proximal stop for advancement and retraction, respectively, of the access guidewire 148. Although not shown, the slider 172 may include an extension that extends into the lumen 156 of the retractable needle device 140 where the slider 172 is coupled to the proximal portion of the access guidewire 148. The aforementioned access guidewire actuator 170 is configured to advance the distal end portion of the access guidewire 148 beyond the needle tip 150 when the access guidewire actuator 170 is moved distally according to the longitudinal slot. Likewise, the access guidewire actuator 170 is configured to withdraw the access guidewire 148 into the retractable needle device 140 as the access guidewire actuator 170 moves proximally according to the longitudinal slot, such as withdrawing a distal portion of the access guidewire 148 into a proximal portion of the shaft or needle lumen proximal of the needle tip 150.

The access guidewire actuator 170 may be actuated to withdraw the access guidewire 148 into the retractable needle device 140 by manual actuation or automatic actuation as described above. With respect to automatic actuation, the carriage 154 of the introducer needle actuation mechanism may be configured to engage the guidewire actuator 170 when the carriage 154 is pushed proximally into the lumen 156 of the retractable needle device 140 by the compression spring 160 due to the relaxation of the compression spring 160. For example, the proximal end of the carriage 154 may be configured to engage the distal end of the slider 172, or an extension thereof, when the carriage 154 is urged proximally into the cavity 156 of the retractable needle device 140 by the compression spring 160. When the introducer needle actuator 152 is automatically actuated, the access guidewire 148 is withdrawn into the lumen 156 of the retractable needle device 140 along with the introducer needle 146 by accessing the distal portion of the guidewire.

The syringe 142 includes a barrel 174, a plunger 176 disposed in the barrel 174, and a syringe tip 178 extending from the distal end of the barrel 174, the syringe 142 being fluidly coupled to a side arm 180 of the coupling hub 144 described below, at least when the RICC assembly 100 is at least in its immediate deployment.

As shown, the plunger 176 may include a plunger extension 194 that extends distally from a distal portion of the plunger along the barrel 174 of the syringe. The plunger extension 194 includes a tab 196 configured to allow a clinician to withdraw the plunger 176 from the barrel 174 of the syringe 142 by pushing the tab 196 proximally (such as during a blood drawing procedure described below). This configuration for withdrawing the plunger 176 from the barrel 174 is advantageous when manipulating the RICC assembly 100 around the coupling hub 144, which is the preferred location for manipulating the RICC assembly 100 to minimize large movements in the distal portion of the RICC 102. Indeed, the more proximal the position of the RICC assembly 100 is manipulated, the greater will be the less unintentional movement of the hand in the distal portion of the RICC 102.

As described above, the coupling sleeve 144 is configured to couple the retractable needle device 140 and the syringe 142 together, such as in the immediate deployment state of the RICC assembly 100. The coupling bush 144 includes: a carriage connector configured to connect to the coupling bushing connection portion of the carriage 154, a side arm 180 extending from one side of the coupling bushing 144, and a side arm connector of the side arm 180 configured to connect with the syringe tip 178 of the syringe 142.

The coupling hub 144 is translucent and preferably colorless for viewing blood flashback from venipuncture using an introducer needle 146. Indeed, the coupling hub 144 includes a sealed blood flashback chamber 182 proximal to the longitudinal through bore of the coupling hub 144 for viewing blood flashback. As described above, the proximal portion of the shaft of the introducer needle 146 that includes the notch 149 is disposed in the flashback chamber 182, the notch 149 being configured to release blood into the flashback chamber 182 when the needle tip 150 of the introducer needle 146 enters the lumen of a blood vessel of a patient. In addition, the side arm 180 of the coupling hub 144 includes a side arm lumen that fluidly couples the syringe 142 to the blood flashback chamber 182 at least in the immediate deployed state of the RICC assembly 100. Once flashback of blood is observed in the flashback chamber 182 through venipuncture using the introducer needle 146, additional blood can be aspirated using the syringe 142 to confirm entry into the vessel lumen. Seals (e.g., gaskets) at the proximal and distal portions of the blood flashback chamber and a seal 184 (e.g., gasket) around the proximal end of the shaft of the introducer needle 146 enable additional blood to be drawn through the seals into the exposed, unwound portion of the guidewire 148 using the syringe 142.

The coupling bushing 144 may also include a tab 186 in a distal portion of the coupling bushing 144. Tab 186 is configured to allow a clinician to use a single finger of one hand to advance RICC102 one-handed over needle tip 150 while holding the distal portion of retractable needle device 140 between the thumb and another finger or fingers of that hand. The tab 186 facilitates a non-contact mechanism for advancing the RICC102 (particularly the distal portion of the catheter tubing 106) over the needle tip 150, into the distal portion of the guidewire 148, or a combination thereof and into a vascular lumen of a patient.

The coupling hub 144, including its side arms 180, may be rigid to hold the syringe 142 in place alongside the retractable needle device 140 in the ric assembly 100, at least in the immediate deployed state of the ric assembly 100. That is, in some embodiments, the aforementioned side arms 180 may alternatively be flexible. In such embodiments, the RICC assembly 100 or its introducer 104 includes a clamp 198, the clamp 198 having a syringe holding portion configured to hold a syringe through the barrel 174 of the syringe 142 and a needle device holding portion configured to hold a retractable needle device through the housing 158 formed by the body of the retractable needle device 140. The needle device gripping portion of the clamp 198 is configured to allow the retractable needle device 140 to slide therein. In other words, retractable needle device 140 is slidably disposed in the needle device gripping portion of clamp 198, which allows for the following introducer needle withdrawal steps.

Fig. 1-4 illustrate the RICC component 100 in at least an immediate deployment state. When the RICC assembly 100 is in the immediate deployed state, slightly more of the needle tip 150 of the introducer needle 146 extends from the distal end of the RICC102 for venipuncture. Indeed, when the RICC assembly 100 is at least in its immediate deployed state, a distal portion (e.g., approximately 7cm) of the shaft of the introducer needle 146 extends along the introducer lumen 122 of the catheter tube 106, through the longitudinal throughbore of the coupling hub 144, through the side bore 114 of the catheter tube 106, and through the distal end of the RICC 102. However, in some embodiments, 1cm to 3cm or more of the distal portion of the shaft can extend from the distal end of RICC102 for venipuncture. In such embodiments, the length of the first section 116 of the catheter tubing 106 is shorter as opposed to the longer length of the shaft. Other ones of the plurality of operating states of the RICC component 100 may be appreciated from the functional aspects of the RICC component 100 described above or the steps of the method for inserting the RICC102 described below.

Method

The methods of the RICC assembly 100 include methods for inserting the RICC102 into a vascular lumen of a patient. In some embodiments, such methods comprise a RICC assembly acquisition step, a needle track creation step, a RICC advancement step, and an introducer needle withdrawal step.

The RICC component acquisition step includes acquiring the RICC component 100. As described above, the RICC assembly 100 includes a RICC102 and an introducer 104. Introducer 104 includes a retractable needle device 140 and a syringe 142 coupled together by a coupling sleeve 144.

Prior to the needle track establishing step, the method may further comprise a needle tip ensuring step of ensuring that the needle tip 150 of the introducer needle 146 extends from the distal end of RICC 102. As described above, the retractable needle device 140 includes an introducer needle 146, with the shaft of the introducer needle 146 extending through the longitudinal throughbore of the coupling bushing 144, through the side bore 114 in the distal portion of the catheter tubing 106 of the RICC102, along the guide lumen 122 of the catheter tubing 106, and beyond the distal end of the RICC102, at least in the immediate deployment state of the RICC assembly 100.

The needle path establishing step comprises: a needle track is established from the skin area of the patient to the lumen of the blood vessel using the needle tip 150 of the introducer needle 146 while holding the distal portion of the retractable needle device 140. The needle track establishing step may also include a sealed blood flashback chamber 182 that ensures blood flashback to the coupling hub 144. As described above, the notch 149 of the shaft of the introducer needle 146 is disposed in the flashback chamber 182 for releasing blood into the flashback chamber 182 upon entering the lumen of a patient's blood vessel.

The method may further comprise a blood aspiration step. The blood drawing step includes drawing blood using the syringe 142 after the needle track establishing step but before the introducer needle withdrawing step. Again, the syringe 142 is fluidly coupled to the blood return chamber 182 of the coupling hub 144 through the side arm lumen of the side arm 180 for the blood aspiration step. The blood aspiration step confirms that the needle tip 150 is disposed in the lumen of the patient's blood vessel.

The method may further comprise an access guidewire advancement step. The access guidewire advancement step includes advancing the distal portion of the access guidewire 148 from the needle lumen of the introducer needle 146 into the vascular lumen, which aids in the success of the first puncture by making the access guidewire 148 immediately available before possible loss due to minor accidental movement of the RICC assembly 100. In some embodiments, the distal portion of guidewire 148 is advanced by sliding slider 172 distally in a longitudinal slot of housing 158 of retractable needle device 140. As described above, the slider 172 may include an extension that is coupled to a proximal portion of the access guidewire 148, the proximal portion being disposed in the cavity 156 defined by the housing 158 of the retractable needle device 140. The entry guidewire advancement step is performed prior to the first RICC advancement step so that the distal portion of the catheter tubing 106 can be advanced over the entry guidewire 148 and the needle tip 150 of the introducer needle 146.

The first RICC advancement step includes advancing the distal portion of the catheter tube 106 into the vascular lumen over the needle tip 150, the access guidewire 148, or both. As described above, the catheter tubing 106 includes a first section 116 formed of a first material having a first hardness and a second section 118 formed of a second material having a second hardness that is less than the first hardness. The first section 116 of the catheter tube 106 is configured to have a column strength for advancing the catheter tube 106 into a vascular lumen over an access guidewire 148 or steering guidewire 136 (which is provided in the steering guidewire advancement step) described below. For example, the first RICC advancement step may include advancing the catheter tube 106 into the vascular lumen using a single finger of one hand (e.g., by a flick-type motion of the finger) while holding the distal portion of the retractable needle device 140 between the thumb and the other finger or fingers of that hand. The coupling sleeve 144 includes a tab 186 configured for advancing the catheter tubing 106 into a vascular lumen using a single finger. When the coupling sleeve is advanced by a single finger, the coupling sleeve 144 in turn advances the catheter tubing 106 into the vascular lumen.

The introducer needle withdrawal step includes withdrawing the shaft portion of the introducer needle 146 from the patient's vascular lumen and the introducer lumen 122 of the RICC102 through the side port 114 of the catheter tube 106. The introducer needle withdrawal step includes actuating the introducer needle actuator 152 of the retractable needle device 140 (e.g., via button 168). As described above, the proximal end portion of the introducer needle 146 is disposed in the spring-loaded carriage 154 of the retractable needle device 140, the carriage 154 being configured to push proximally into the cavity 156 of the retractable needle device 140 upon release of the compressed compression spring 160 around the carriage 154 by the introducer needle actuator 152.

The method may further include an access guidewire withdrawal step of withdrawing the access guidewire 148 from at least the lumen of the patient's blood vessel. The entry guidewire withdrawal step may be performed manually by manually actuating the entry guidewire actuator 170. For example, the guidewire 148 may be manually withdrawn from the patient's vascular lumen by sliding the slider 172 proximally in a longitudinal slot of the housing 158 of the retractable needle device 140. Alternatively, the entry guidewire withdrawal step may be performed automatically by automatically actuating the entry guidewire actuator 170. For example, the carriage 154 of the introducer needle actuation mechanism may be configured to engage the guidewire actuator 170 (e.g., the slider 172 or an extension thereof) when the carriage 154 is urged proximally into the lumen 156 of the retractable needle device 140 by the compression spring 160. Thus, when the guide needle actuator 152 is actuated to release the spring-loaded carriage 154 in the guide needle withdrawal step, an access guidewire withdrawal step is also performed.

In combination, the guide needle withdrawal step and the entry guidewire withdrawal step may be considered an introducer removal step that completely removes introducer 104 from RICC 102. However, depending on the length of the access guidewire 148, the introducer removal step may further include separating the introducer 104 from the RICC102 a distance sufficient to fully withdraw the access guidewire 148 from the guide lumen 122 of the RICC102 through the side hole 114 of the catheter tube 106. The introducer removal step may be performed after the first RICC advancement step (such as after properly placing the distal portion of the catheter tube 106 within the vessel lumen over both the needle tip 150 and the access guidewire 148).

The method may further manipulate the guidewire advancing step. The steering guidewire advancement step includes advancing a steering guidewire 136 into the vascular lumen through, for example, a distal lumen aperture 130 in the distal end of RICC 102. As described above, the guide lumen 122 of the catheter tube 106 coincides with the distal end portion of the distal lumen 124 (particularly the distal end portion of the distal lumen 124 distal to the side hole 114). As such, an introducer removal step requiring complete removal of introducer 104 from RICC102 prior to the steering guidewire advancement step ensures that distal lumen 124 or its guide lumen 122 is neither guide needle 146 nor guidewire 148 accessed.

The method may further comprise a second RICC advancing step: the distal portion of the catheter tube 106 is further advanced over the steering guidewire 136 into the vessel lumen, such as into the SVC. Steering guidewire 136 provides sufficient column strength of second section 118 of catheter tube 106 for the second RICC advancement step.

When there is a sterile barrier over the catheter tubing 106 between the catheter hub 108 of the RICC102 and the side hole 114 of the catheter tubing 106, the method may further comprise a sterile barrier removal step. The sterile barrier removal step includes removing the sterile barrier. The sterile barrier is removed by tearing the sterile barrier apart by pulling the sterile barrier tab of the proximal portion of the sterile barrier away from the catheter tubing 106.

The method may further include a steering guidewire withdrawal step of withdrawing steering guidewire 136 from the patient's vascular lumen and completely removing steering guidewire 136 from RICC 102.

Although certain specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications may be apparent to those of ordinary skill in the art, and in broader aspects, such adaptations and/or modifications are also contemplated. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.