WO2018089385A1

WO2018089385A1 - Needle cover apparatus

Info

Publication number: WO2018089385A1
Application number: PCT/US2017/060468
Authority: WO
Inventors: James D. Mitchell; Andrew A. THORESON
Original assignee: Redsmith, Inc.
Priority date: 2016-11-08
Filing date: 2017-11-07
Publication date: 2018-05-17

Abstract

A needle cap assembly for protecting an access needle used with an integrated medical device. The needle cap assembly includes a needle cap body having a medial cylindrical portion and a tapered conical distal portion. The medial cylindrical portion and the tapered conical distal portion define a cavity configured for receipt of the access needle. A cap riser is connected to the medial cylindrical portion and includes a cavity configured to receive the integrated medical device.

Description

NEEDLE COVER APPARATUS

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims priority to U.S. Pat. App. No. 62/419,444 filed November 8, 2016, entitled Needle Cover Apparatus, 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 an apparatus for constraining a needle, or portions of a needle, to maintain integrity of the system before use, and prevent injury to oneself immediately prior to use in the medical patient.

BACKGROUND OF THE INVENTION

[003] All sharp medical devices used in contemporary medicine require the use of a mechanism to contain or constrain the sharp end, acting as a so-called "cap". Such cap is in place to prevent the accidental injury to oneself, or premature, unintended injury to the patient, prior to the device's intended use. The cap also maintains constraint of the device together as a unit during packaging and immediately prior to use.

[004] Devices that comprise a cap as a component are typically those used for venipuncture or arterial access. Venipuncture refers generally to a process of obtaining percutaneous access into a patient's vein for one of many potential applications, including, but not limited to, the infusion of fluids, medication, and blood products, and the like.

Alternatively, such device could be used to aspirate blood samples for laboratory assessment and the like. Furthermore, devices can be used to access the arterial system in a similar manner, with typical intended use for measurement of intravascular blood pressure monitoring and arterial blood gas measurement, amongst other less common applications. Finally, sharp medical devices in the scope of the present discussion include, most typically, other needles, such as sutures, trocars, and other access needles.

[005] Specifically, in the prior art, an exemplar of a needle requiring a cap is the typical intravenous or "IV" access needle. Here, the needle is linear, and comprises a needle with sharp distal end, and a proximal receiving hub. A "cap", as indicated by the term, implies a member with a cavity closed on one end as to terminate the end of an elongate member. Said cap then receives an elongate member such as a needle intended for venipuncture.

[006] Furthermore, however, a cap could be a semi-fixed elongate member having both open proximal and distal ends. Such cap, although an open member on both ends, is constructed in such a manner for the benefit of manufacture or ease of use and is of sufficient length as to constrain the length of the entire needle, and beyond the needle tip, to prevent inadvertent injury. Exemplars of such double open needle caps are typically those needles of more appreciable length as seen in trocars and biopsy devices, amongst others.

[007] Regardless of overall design, as there are many subtle differences in the art, the overall objective is the same - to provide safety for all those that are potentially in contact with the sharp object. In this regard, it is important to ensure that the needle cap easily and safely fits the intended sharp device, which the cap remains engaged with the sharp device until removal is desired, and that the cap can be replaced should sharp device require recapping for the protection of the user or others. SUMMARY OF THE INVENTION

[008] It is, therefore, advantageous to provide a needle cap comprising a generally elongate member with an elongate cavity extending axially therein to receive and constrain a needle or other sharp device. The cavity of the cap is constrained on its distal end to cover and protect the sharp end of the needle contained therein. Furthermore, the proximal portion of the cap is open to receive the needle hub and remained fixed in place until desired cap removal.

[009] In the preferred embodiment, the cap not only constrain an access needle, but also constrains the needle and an integrated device. Such integrated device is represented in the present invention as a central venous catheter with preassembled, preloaded needle and disclosed in U. S. Ser. No. 15/008628 for Rapid Insertion Integrated Catheter and Method of Using an Integrated Catheter, which is incorporated herein by reference. The cap could also be used to cover and constrain any other combination of needle and catheter as could be envisioned. Such needle/catheter combinations include, but are not limited to a combination of needle and central venous catheter, midline or extended dwell peripheral intravenous catheter, peripherally inserted central catheter, peripheral intravenous (IV) line, or other vascular access device.

[010] The present invention comprises an elongate tubular member that covers a substantial length of a needle or needle integrated with another device. The needle cap may have a closed distal end, a partially closed distal end, or an open distal end so as to cover and/or protect the needle tip. It may be desirable for the distal tip to be vented to facilitate the sterilization processes during manufacturing of the device (i.e., allow gases to escape), while also effectively providing sufficient closure to prevent accidental needle injury. The proximal end of the device is open to integrate and receive the hub of the access needle. The proximal end has a locking means to integrate with the needle hub and remain locked in place until the user detaches or reattaches said cap.

[Oil] Preferably, the locking means comprises one or more tabs oriented in a generally circumferential or arcuate arrangement around the periphery of the proximal open end. These tabs then integrate with the hub of the access needle. The tabs are separated by slots, providing the tabs having the appearance of separate leaves or petals. For the purposes of this specification, this will be referred to as a "petal configuration". Said petals, themselves, are oriented in a generally radial configuration extending proximally from the open proximal end. [012] The petals provide for the locking means while integrating with the receiving portion of the needle hub. These tabs, or petals, in combination with the interspaced slots separating the petals, integrate with the corresponding shape of the proximal needle hub, and create the capping mechanism. Such capping mechanism remains locked with the needle hub until the user pulls the cap with sufficient force to release the attachment. [013] For the applications of the present invention, the access needle is preferably integrated with another access device. For simplicity of the application, we will refer to this preferred device as a central venous catheter (CVC). Although, as previously mentioned, the integrated device could be one of many in the art, known currently, or not currently known.

[014] Furthermore, for ease of discussion, the example given in this specification also includes a nonlinear needle that is integrated with the central line. However, it is in the scope of the present invention to utilize a linear needle. Specifically, the needle in the example takes an elongated S-shaped curvilinear course, beginning at the hub, bending slightly in one direction, and then the opposite, to reassume an all-together forward-oriented needle. Hence, the needle cap is not completely linear in the example. Again, it is in the spirit of the present invention to include all potential needle shapes and their integrated devices. As such, one skilled in the art could envision a cap of slightly varying shape from truly linear, and other designs having varying relationships between the cap opening and the other substantial portion of the needle barrel.

BRIEF DESCRIPTION OF THE DRAWINGS

[015] Figure 1 is a side perspective view showing the needle cap of the needle cover according to the present invention;

[016] Figure 2 is a top plan view of the needle cap of Figure 1 ;

[017] Figure 3 is a bottom plan view of the needle cap of Figure 1 ;

[018] Figure 4 is a perspective view of the needle cap of Figure 1 ;

[019] Figure 5 is a proximal end view of the needle cover;

[020] Figure 6 is a side perspective view of the needle cover in a locked position with the needle and integrated central line;

[021] Figure 7 is a perspective view of a catheter with the needle cap thereon;

[022] Figure 8 is a side elevational view of the needle cap connected to a needle hub;

[023] Figure 9 is a side elevational view, partially broken away, of the needle cover; and

[024] Figure 10 is a perspective view, partially broken away, of the needle cover.

DETAILED DESCRIPTION OF THE INVENTION

[025] 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. [026] As used herein, the term "proximal" is used to refer to the end of the member or device closest to the practitioner using the member or device. The term "distal" is used to refer to the end of the member or device in the direction of use of the device, such as the end for obtaining vascular access. The phrase "longitudinal axis" refers to an axis extending between proximal and distal ends. The term "radial" refers to a direction transverse to the longitudinal direction, at any angle.

[027] As shown in Figures 1-10 an exemplary needle cap 10 for integrated access needle 19 and central venous catheter 20 with exemplary needle 19 representing a nonlinear needle including a curved or angularly oriented portion 17 as shown in Figure 6. The needle cap assembly 10 includes a needle cap body 21 having a medial cylindrical portion 1 land a tapered conical distal portion 12 defining a cap tip 14. The medial cylindrical portion 11 has a predetermined diameter to accommodate the needle 19 and defines a proximal opening 24. The medial cylindrical portion 11 is hollow and, together with the hollow tapered conical distal portion 12, defines a first cavity 22 configured for receipt of the access needle. As shown in Figure 1, the first cavity 22 has a longitudinal axis A.

[028] The needle cap assembly 10 also includes cap riser 13 on its proximal end. The cap riser 13 defines a cap opening 15 and has a width which is greater than the diameter of the medical cylindrical portion 11 as shown. The needle cap 10 defines a second cavity 18 having a second longitudinal axis B configured for receipt of the integrated medical device 20, such as a medical device 20 including a needle hub 30. The longitudinal axis A is offset from the longitudinal axis B to accommodate an integrated medical device wherein the needle hub 30 is received within the second cavity 18 of the cap riser 13 and the needle 19 is received within the first cavity 22 defined by the medial cylindrical portion 11 and conical portion 12. The second cavity 18 is defined by the proximal cap riser opening 15 and cap riser distal wall 23. As shown, the cap riser distal wall 23 is positioned distally to the medial portion opening 24. Together, the medial portion opening 24 and the cap riser proximal opening 15 form a substantially continuous opening. However, the first and second cavities 22, 18 are not substantially in open communication along lengths thereof.

[029] A cap tip 14 terminates the distal end of the needle cap 10 at the distal end of the tapered conical portion 12 in order to completely cover the sharp tip of the needle 19.

Alternative embodiments of the distal cap tip 14 include an open tubular portion of the cap that is sufficiently long to cover the needle and prevent inadvertent injury.

[030] The cap riser opening 15 comprises a system of one or more petal tabs 16 that removably integrate with the needle hub 30 of needle 19. Here, for purposes of discussion, our exemplary system comprises three petal tabs 16. The tabs are separated by tab slots 37.

[031] When engaged with the needle hub 30, the tabs 16 and slots 37 integrate with the needle hub 30 so as to slidably fit the needle hub 30. More specifically, a clipping action occurs with the slidable action so the needle cap 10 remains engaged with the needle 19 until removal. Such removal requires sufficient force to allow the petals 16 to unclip and/or expand radially outwardly from the needle hub 30. The remaining movement of the cap 10 removal is forward/distal sliding of the cap 10 to substantially expose the full length of the needle 19 and integrated device for its use. Should the device not be used, the cap can be replaced in a similar method of first slidably advancing the cap back over the sharp device and engaging the petal tabs to clip onto the hub once again.

[032] The example contained herein shows a cap device 10 for the intended use with a needle 19 that is integrated with another device. As such, the cap 10 requires a cap riser 13 to allow for the larger-sized and nonlinear preassembled needle-device. The needle cap member 10 could altematively be straight to cover only a single linear needle, or comprise a different size or shape of the riser 13 to accommodate alternate devices. [033] 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 cap assembly for an integrated medical device and an access needle for obtaining vascular access comprising:

a medial cylindrical portion extending between proximal and distal ends, said medial cylindrical portion defining a proximal opening and having a diameter;

a tapered conical portion extending from said medial cylindrical portion distal end, said medial cylindrical portion and said conical portion defining a first longitudinal cavity having a first longitudinal axis and configured for receipt of the access needle, said tapered conical distal portion defining a cap tip;

a cap riser connected to said tapered conical portion proximal end, said cap riser extending between proximal and distal ends, and having a width greater than said medial portion diameter wherein said cap riser proximal end defines a proximal cap opening and a second longitudinal cavity between said cap riser proximal and distal ends having a second longitudinal axis configured for receipt of the integrated medical device and wherein said first longitudinal axis is offset from said second longitudinal access; and

wherein said proximal cap opening of said riser defines at least one flexible tab which cooperates with the integrated medical device to secure the needle cap assembly to the medical device and for positioning said first longitudinal cavity of said medial cylindrical portion and said tapered conical portion for receiving said access needle and wherein forces applied distally to said needle cap assembly disconnects said at least one tab form said integrated medical device.

2. A needle cap assembly according to Claim 1 wherein said cap riser defines a closed distal end.

3. A needle cap assembly according to Claim 1 wherein a portion of said cap riser between said proximal and distal ends extends adjacent a proximal portion of said medial cylindrical portion wherein said cap riser distal end is positioned distally from said proximal opening of said medial cylindrical portion.

4. A needle cap assembly according to Claim 3 wherein said proximal opening of said medial cylindrical portion and said proximal cap opening are adjacent one another so as to define a substantially continuous opening for receiving the access needle and integrated medical device.

5. A needle cap assembly according to Claim 4 wherein said first and second cavities are substantially not in open communication along lengths thereof.

6. A needle cap assembly according to Claim 1 wherein said cap tip defines an aperture and said tapered conical portion is configured to enclose the access needle.

7. A needle cap assembly according to Claim 1 wherein said proximal cap opening defines at least two flexible tabs and a slot between said two tabs for cooperating with the integrated medical device.

8. A needle cap assembly for an integrated medical device and an access needle for obtaining vascular access comprising:

wherein said first and second cavities are substantially not in open communication along lengths thereof.