WO2018089275A1

WO2018089275A1 - Needle hub assembly for a medical device

Info

Publication number: WO2018089275A1
Application number: PCT/US2017/060065
Authority: WO
Inventors: James D. Mitchell; Andrew A. THORESON
Original assignee: Redsmith, Inc.
Priority date: 2016-11-08
Filing date: 2017-11-04
Publication date: 2018-05-17

Abstract

A needle hub assembly including a needle and a needle hub to facilitate vascular access with a medical device. The needle hub includes a securement member for securing the medical device to the needle.

Description

NEEDLE HUB ASSEMBLY FOR A MEDICAL DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims priority to U.S. Pat. App. No. 62/419,435 filed November 8, 2016, entitled Needle Hub Assembly For A Medical Device, the disclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

[002] The present invention is directed, generally, to the field of vascular access and systems for performing venipuncture, arterial puncture, placement of a vascular line, and other such related procedures. More particularly, the present invention provides a novel hub assembly including a needle and a needle hub to facilitate vascular access with a medical device.

BACKGROUND OF THE INVENTION

[003] Needle access systems are ubiquitous in the medical setting. Typically, access needles, regardless of their intended use, are linear and have an elongate shape with distal sharp tip and proximal needle hub. A needle hub is conventionally integrated with the needle shaft and provides a means for the needle to be attached to another device, such as medical tubing, or provide wire access through the needle for additional application. The hub generally comprises one of two common attachments - one with externally disposed spiral threading (the so-called Luer lock), and one with smooth internal and external fitting (the so- called slip tip). [004] Once access is obtained in the vein or artery with the distal needle tip, an associated device, such as the flexible intravenous catheter, is advanced over the needle into the vessel. When access is obtained and the device is in place, the rigid needle is removed, leaving the device singularly in the vessel. Alternatively, when vascular access is obtained and confirmed, a guidewire is advanced though the proximal needle hub and ultimately, in the vessel where the rigid needle is removed, leaving the wire singularly in place until another device is advanced over the guidewire into place within the vessel lumen.

[005] Conventional needle access systems are effective and widely employed with conventional medical devices. Recently, needle access systems may include integrated devices beyond simply a needle with or without an associated intravenous catheter. For instance, a needle may be preloaded or integrated in another fashion with other vascular access devices to include central lines (CVCs), midlines and extended-dwell peripheral intravenous lines (EDPIVs), and peripherally inserted central venous catheters (PICCs), amongst other devices. One such exemplary contemporary device can be seen in U.S. Ser. No. 15/008628, Rapid Insertion Integrated Catheter and Method of Using an Integrated Catheter.

[006] When a needle is integrated with a device, the added device, although advantageous as a rapid and safe integrated system, requires additional components that must be constrained together in either a temporary or permanent fashion to facilitate stability of the system and ease of use. In this regard, it is important to consider a needle hub assembly that allows a user to establish a secure connection between the needle and integrated device. Additionally, the needle constitutes the accessing portion of the system that must remain fixed. The needle hub assembly according to the present invention, therefore, provides a novel needle for use with a medical device and a novel needle hub for removable connection with an integrated device, such as a fully integrated catheter having a side port for receiving the needle.

SUMMARY OF THE INVENTION

[007] It is, therefore, advantageous to provide an improved needle hub assembly for performing vascular access, particularly those devices that contain or integrate with other devices and systems. Whilst the assembly described herein is particularly useful for facilitating the placement of an integrated device with needle system into a central or peripheral vein, the present invention could be used with a general tubular needle access system for the arteries or, perhaps, access devices for the viscera and other structures of the body. The hub assembly according to the present invention may be used in conjunction with any medical device employing a guidewire, including U.S. Ser. No. 15/008628 for Rapid Insertion Integrated Catheter and Method of Using an Integrated Catheter, which is incorporated herein by reference. As used herein, the terms "proximal" and "distal"

(excluding horizontal cross-sections) are used to refer to the axial ends of the assembly. The term "proximal end" refers to the end closely adjacent the user of the assembly and the term "distal end" refers to the end of the assembly to be intravascularly positioned.

[008] A needle hub assembly in accordance with the present invention comprises a hollow needle attached to a needle hub. The needle is generally elongate and hollow, and may be entirely linear or even curvilinear. A doubly-curved needle with elongate S-shape is provided as an exemplary model. The hub proximal end comprises an open end that may have either smooth, slip-tip type fitting, or threaded Luer fitting.

[009] Preferably, the hub comprises a hub securement member. The securement member is meant to grab or clip another apparatus in place parallel to, and generally disposed, along the long axis of the needle. The securement member would be preferably arcuate and mostly semicircular in its curve, although may translate in an arc greater or less than a true semicircle.

[010] Preferably, the securement member holds a device in place to be used with the needle for vascular access. According to one aspect, the securement member is intended to hold a central venous catheter or other vascular access device. The securement member acts to stabilize the central venous catheter in place while obtaining access with the attached needle. Again, one skilled in the art could envision this type of securement member to be used with other medical or surgical access devices.

[Oil] Additionally, to facilitate the grasping mechanism of the securement member, the needle hub may or may not have a member recess, or indentation, on the hub outer surface to facilitate improved clamping and inward radial force on the device to be held by the securement member. The securement member is intended to hold, in a semi-fixed manner, a central line or other device, during needle access and introduction of the needle-device system. The securement member provides significantly improved rigidity to the overall system for improved safety and ease of use.

[012] Once durable access is obtained with the needle and/or associated guidewire, the central line may be detached from the member in an unclipping fashion. Once detached, the central line or other device may slidably advance over the needle and away from the hub and securement member.

BRIEF DESCRIPTION OF THE DRAWINGS

[013] FIG. 1 is a side elevational view of the needle assembly including the needle and needle hub;

[014] FIG. 2 is a bottom plan view of the needle assembly of Figure 1 ; [015] FIG. 3 is a perspective view of the needle hub of Figure 1;

[016] FIG. 4 is a proximal end view of the needle hub of Figure 1;

[017] FIG. 5 is a distal end view of the needle hub of Figure 1 ;

[018] FIG. 6 is a perspective view of a catheter utilizing the needle assembly;

[019] FIGS 7 A and 7B are additional perspective views of a catheter utilizing the needle assembly; and

[020] FIGS 8A and 8B are top plan and side elevational views, respectively, of a catheter utilizing the needle assembly. DETAILED DESCRIPTION OF THE INVENTION

[021] The present invention will now be described in detail hereinafter by reference to the accompanying drawings. The invention is not intended to be limited to the embodiments described; rather, this detailed description is provided to enable any person skilled in the art to make and practice the invention.

[022] Referring to the drawings, a needle hub assembly 10 includes a generally elongate tubular, hollow needle 1, comprising a needle shaft 11, and a hub 12. The needle shaft 11 terminates at the preferably beveled, hollow needle tip 13 with distal needle opening 18. According to one aspect of the present invention, the needle is nonlinear and includes a curved intermediate portion 20 along its proximal needle shaft 11. It is within the scope of the present invention, however, to provide a linear or other non-linear configured needle shaft 11 without departing from the spirit or scope of the invention. The needle 1 is connected to the hub body 12 at its proximal end.

[023] The needle hub 12 defines a cavity 14 configured to receive the needle shaft 11 through a distal aperture 3 and a proximal aperture 23. The hub 12 further comprises at least one hub grip 16, and preferably a plurality of grips 16, for example four as shown, which are flanges extending outwardly from the circumferential surface of the hub 12 to facilitate the grasping of the hub 12 during use.

[024] Furthermore, the hub 12 includes a hub securement member 17 extending outwardly from the hub body. The securement member 17 is configured for receipt of a tubular medical device, such as a central venous catheter 32 as shown in Figures 6-8. The securement member 17 defines a concave seat 19 for receipt of a portion of the catheter 32. The hub assembly 10 further comprises a securement member recess 20 defined by a groove on the hub surface adjacent the securement member. Recess 20 provides a seat for the catheter 32 when the hub 12 is connected thereto. This indentation 20 further secures the catheter by providing additional surface area configured to receive the catheter and provides radial, frictional forces to removably retain the central catheter or other device.

[025] The central line or other device connected to the securement member 17 may be engaged with the needle 1 in a preassembled form or may be clipped into the securement member prior to use. Once access is obtained with the needle hub assembly 10, the central line or other device that is retained in the securement member 17, is undipped or slidably advanced off or through the securement member 17.

[026] For the purposes of its use with the rapid insertion venous catheter as shown in Figure 6, the needle hub assembly 12 is attached to the proximal end of the venous access needle 1. The catheter assembly 30, as shown in Figures 6, 7 and 8, includes, generally, a triple lumen catheter 32, hollow needle 1 having a guidewire preloaded therein, and hub assembly 10. The guidewire enters the catheter lumen from a side port. Alternatively, the guidewire may be inserted into the access needle during the procedure, that is, it is not "pre-loaded" into the needle. The assembly 10 may also be used in a manner as to be contained within the housing of a peripheral IV (PIV) or midline/extended dwell peripheral IV (EDPIV) device, or as a mechanism to be used in conjunction with any type and configuration of a peripheral or central line. One skilled in the art of vascular access and minimally invasive procedures could also envision a device that could contain this mechanism not only for peripheral or central venous access, but also for arterial access as is seen in arterial lines for invasive vital sign monitoring, or hemostatic vascular sheaths for venous/arterial procedures, for example. Additionally, the guidewire device 10 described herein could be used in conjunction or incorporated in a device used for percutaneous access into any cavity as is seen in image- guided drain/catheter placements into an abscess, the renal collecting system, biliary system, or any space or potential space of the human body.

[027] While exemplary embodiments have been shown and described above for the purpose of disclosure, modifications to the disclosed embodiments may occur to those skilled in the art. The disclosure, therefore, is not limited to the above precise embodiments and that changes may be made without departing from its spirit and scope.

Claims

WHAT IS CLAIMED IS:

1. A needle hub assembly for obtaining vascular access for a medical device comprising: a needle hub having a proximal and distal end for selectively connecting to the medical device; a needle having a proximal end connected to said needle hub distal end and a central lumen configured for receipt of a guidewire; a securement member extending outwardly from said needle hub and defining a seat configured for receipt of a portion of the medical device to position said needle for cooperation with the medical device to achieve vascular access.

2. A needle hub assembly according to Claim 1 wherein said securement member is substantially arcuate and defines a concave seat for receipt of a correspondingly configured portion of the medical device.

3. A needle hub assembly according to Claim 2 wherein said needle hub further defines a recess adjacent said securement member for further facilitating receipt of the medical device.

4. A needle hub assembly according to Claim 1 wherein said needle hub comprises at least one flange extending outwardly from an outer surface.

5. A needle hub assembly according to Claim 4 wherein said needle hub comprises at least two of said flanges.

6. A needle hub assembly according to Claim 1 wherein said needle is nonlinear.

7. A needle hub assembly according to Claim 6 wherein said needle comprises an intermediate portion which is non-linear with respect to the proximal portion of the needle adjacent said needle hub.

8. A needle hub assembly according to Claim 1 wherein said needle is preloaded with the guidewire.

9. A needle hub assembly according to Claim 1 wherein said needle extends from said needle hub and into a longitudinal side of the medical device when said needle hub is connected to the medical devices by said securement member.

10. A needle hub assembly according to Claim 1 wherein said needle hub is positioned alongside the medical device between proximal and distal ends of the medical device when connected by said securement member.