WO2013152209A1

WO2013152209A1 - Port needle and methods of use thereof

Info

Publication number: WO2013152209A1
Application number: PCT/US2013/035299
Authority: WO
Inventors: Tammy LIGHTNER
Original assignee: The Children's Mercy Hospital
Priority date: 2012-04-04
Filing date: 2013-04-04
Publication date: 2013-10-10

Abstract

The present invention overcomes the obstacles of the prior art and provides for a port access needle device that is specifically design for clinical use or family care. Preferably, the device provides visual accessibility of the needle insertion site such that the site can be monitored for signs of infection. Advantageously, such visualization provides an opportunity for both identification and early interventio in the event of a CBABSI and reduces the severity thereof. In preferred forms, the device includes a safety mechanism to prevent or reduce the incidence of needle stick injuries prior to, during, and after the use of port access needles in accordance with the present invention.

Description

PORT NEEDLE AND METHODS OF USE THEREOF

FIELD OF THE INVENTION

[0001] This invention relates to a port access needle device, suitable for accessing ports using a non-coring needle either clinically or in a family care environment.

BACKGROUND OF THE INVENTION

[0002] All venous access systems, including implantable venous and arterial access portal systems, are designed to permit repeated access to the patient's venous system for the parenteral delivery of medications, nutritional solutions, other fluids, and for the sampling of venous blood. Venous systems may be placed in the arm or chest. To access the implanted portal, percutaneous puncture with a needle, preferably a non-coring needle, through skin and the portal septum, is needed.

[0003] While venous access systems provide a wide range of applications ranging from anesthesia, IV, fluid delivery, to blood draws, the increased use of portal access needles has raised safety concerns. According to the best estimates available, central line-associated blood stream infections (CLABSIs) account for only about 15% of all hospital infections, but are responsible for at least 30% of the 99,000 annual hospital infection-related deaths. Further, studies have shown that each year there are more than 800,000 needle stick injuries to healthcare workers in the U.S. alone. Each needle stick injury is costly to the healthcare system and carries the risk of transmission of blood borne pathogens which can lead to long-term complications of HIV, hepatitis B and hepatitis C infections, costing many thousands of dollars. Healthcare workers are the most often affected, but patients, family members, or other personnel are also at risk of being injured by a needle stick. Therefore, portal access needle devices providing ease of use, promoting clinician and patient safety by reducing risks of CLABSIs as well as needle stick injury during access, de-access, and disposal following each use of the access needle are in great need. SUMMARY OF THE INVENTION

[0004] The present invention overcomes the obstacles of the prior art and provides for a port access needle device that is specifically designed for clinical use or family care. Preferably, the device provides visual accessibility of the needle insertion site such that the site can be monitored for signs of infection. Advantageously, such visualization provides an opportunity for both identification and early intervention in the event of a CBABSI and reduces the severity thereof. In preferred forms, the device includes a safety mechanism to prevent or reduce the incidence of needle stick injuries prior to, during, and after the use of port access needles in accordance with the present invention. Advantageously, the port access needle device of the present invention also provides a single use needle that permits safe storage, application, and disposal and avoids the concerns relating to needle stick injuries to medical personnel, patients, and care-givers who use port access needles on a frequent basis. Further, the port access needle device is designed for easy operation such that the user can visualize and thus optimizes the port insertion site assessment, avoids trial-and-error in sticking the needle to the port, prevents needle sliding by stabilizing the device while pushing and pulling the needle, and enables precise and fast access and de-access to implanted ports.

[0005] In one aspect of the present invention, a safety port access needle device which conforms to existing procedures for administering injections and allows unrestricted access for vascular access or catheter insertion is provided. Preferably, a port access needle as described herein includes the fewest number of components so that it can be produced at the lowest possible cost needed to accomplish the intended task of providing acceptable, low cost, error- free, single-use port access needle for the healthcare industry.

[0006] In another aspect of the present invention, the port needle device of the invention generally comprises a port access needle secured to a protective cover, a padding affixed to the bottom plate of said protective cover, and a safety needle mechanism having a retaining means allowing the sharpened end of the needle to be trapped in or shielded by the safety casing when the device is not in use. Preferably, said protective cover of the port needle device of the present invention has a top arm, a bottom plate pivotally connected to the top arm and having a pair of side wings extending away in a direction generally perpendicular to the top arm. Preferably, the bottom plate also includes an opening beneath at least a portion of the top arm and between the side wings. In some preferred forms, the padding of the device has an opening of same shape and size as the space contained in the bottom plate to provide a window for insertion site visualization. In other preferred forms, the opening in the padding is smaller or larger than the opening in the bottom plate.

[0007] In another aspect of the invention, a safety port access needle device which is manually operable is provided. In one preferred embodiment, the top arm of the protective cover to the port access needle device is rotatably connected to the bottom plate. In one embodiment, the movable, or rotary, connection is via a pivot extending upward from the bottom plate at one end. Such a pivot may include a detent, a shaft or axle extending through a hole on each side of the pivot, and the like.

[0008] In yet another aspect of the invention, the port access needle device further comprises a coil spring positioned between the top arm and the bottom plate at the end where the pivot is located. The spring provides the biasing force when pushing or pulling the top arm to enable a smooth and controlled transition between a retracted configuration and an operative configuration. When the port access needle device is in a retracted configuration, the top arm is at a starting angle with the bottom plate, and the sharpened needle tip is locked, entrapped, resting in, shielded by, or secured in the safety casing. Depending on the size and the length of the needle, the starting angle between the top arm and the bottom plate in a retracted position is between about 10 degrees to about 80 degrees. In other embodiments, the starting angle in a retracted position is about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80 degrees, or any other angle within the range. In one preferred embodiment the starting angle in a retracted position is 30 degrees. In another embodiment, the starting angle in a retracted position is 60 degrees. When the port access needle device is in an operative configuration, in which the operational angle between the top arm and the bottom plate is smaller than the starting angle, the sharpened needle tip is released from the safety casing and travels down award across the openings of the bottom plate and the padding. When the operational angle reaches close to about zero degree, the port access needle device is in a full- operative configuration, which means that the needle can penetrate the skin and access an implanted port device, such as a PORT-A- CATH® (Smith's Medical, St. Paul, MN).

[0009] In another aspect of the invention, a safety port access needle device which renders the insertion site visible and the port puncture error-free is provided. Preferably, the device is single-use in nature. Preferably, in one embodiment, the bottom plate of the port access needle device has an opening, or a window area, between the two ends and two side wings of the bottom plate. One preferred embodiment further provides a pad underneath the bottom plate having a opening of matching size and position to the opening of the bottom plate. In one embodiment, the protective cover of the port access needle device is a clear casing that enables the skin in the area enclosed by the openings of the bottom plate and the padding to be visible, thereby optimizing the needle insertion site assessment. In another embodiment, the protective cover of the port access needle device is made of clear plastic, gel, or the like, to provide visualization of the insertion site, where the needle enters the skin. In all such embodiments, visibility of the insertion site permits identification of and intervention for any potential problems including CBABSIs. Through early identification of and intervention for insertion site issues, the present invention will reduce the severity of or incidence of CBABSIs.

[0010] In another aspect of the present invention, a safety port access needle device which is compatible to existing port access needles of various types and sizes is provided.

[0011] In another aspect of the present invention, a safety port access needle device that allows a protective cover to be used with straight needles, or bent needles that include a change in axis at the sharpened distal tip, such as implanted port needles or needles with a "Huber" tip is provided. In one preferred embodiment, a user can assemble a port access needle of a desired size to the protective cover prior to use. In such forms of the invention, the device includes the components noted above, but without a needed included therein. The needle can be attached by a user or automatically.

[0012] In another aspect of the present invention, the safety port access needle device of this invention is manufactured by automation and thus is assembled with needles of predetermined size and type and is ready-to-use. In one preferred embodiment, the non-coring port access needle is mounted on or secured to the protective cover. In preferred forms, the port access needle size and/or gauge used in the device is designated by color, symbol, numerical, other written indicia, wing shape, cut-out shape on at least one of the wings, shaped protrusion on the device, protrusion or indention along the outer edge, or other coding. For example, a 22 gauge needle could be designated by the color yellow, a sunflower, the number 22, or a zig-zag shape for the outer edge of at least one side wing. Preferably only one such designation would be utilized on the device, but having additional designations thereon is envisioned. It is understood that the designation can appear anywhere on the device, but one preferred embodiment includes side wings having a color that indicates the needle size. In preferred forms, the color still permits visualization of the insertion site. Upon seeing the designation, a user would automatically know what size of a needle was being used, thereby making replacement easier as well as more accurate and more efficient. In some preferred forms, the packaging for the needles or devices would include a corresponding designation Incorrect use of needles of the wrong size increases port puncture, infiltrations, and extravasations, and therefore it is important in preferred forms of the invention that the size of the needle is unambiguously indicated or provided by the port access needle device of the present invention. In one embodiment, the designation is presented on the top arm of the protective cover of the port access needle device. In another embodiment, the designation is on at least one of the wing members of the bottom plate of the port access needle device. In yet another embodiment utilizing a color coding designation, the designation is formed by colored material used in the manufacturing process. In still another embodiment, the designation is provided by a label attached to the port access needle device.

[0013] In another aspect of the invention, a safety port access needle device is provided that permits patient comfort and ease of application. In one preferred embodiment, the port access needle device of the present invention comprises a pair of opposed, outwardly-extending wing members on sides of the bottom plate. In preferred forms, the pair of wings is perpendicular to the longitudinal axis of the opening of the bottom plate. In one embodiment, the pair of wings is an integral part of the bottom plate. In another embodiment, the two wings are removably attached to the bottom plate and can be attached to the side of the bottom plate during manufacturing and thereby become a part of the bottom plate. In one preferred embodiment, the width of the port access needle device is about 2 inches from wing to wing with the length of the bottom plate being about 1 inch. Preferably, the wings are made of material having flexibility such that the user can press, pinch, push, or otherwise compress them down onto the patient's skin in order to stabilize the port access needle device during application and ensure proper needle placement and precise needle insertion. Preferably, an adhesive is on the bottom side of the side wings to secure them to the patient's skin.

[0014] In another aspect of the invention, the safety port access needle device generally comprises a padding affixed to the bottom plate with a thickness providing a distance from the bottom of the bottom plate to the patient's skin. In one preferred embodiment, the padding is made of an absorbent material including, but not limited to, sponge, gel, cotton gauze, and microfiber. Preferably, the padding is impregnated with suitable antiseptic agent including, but not limited to, chlorehexidine, alcohols, chlorine, hexachlorophene, iodophors, chloroxylenol (PCMX), quaternary ammonium compounds, and triclosan.

[0015] In yet another aspect of the present invention, a safety port access needle device which entraps or captures the sharpened tip of the needle prior to and after use is provided. In such an embodiment, the port access needle device effectively shields the sharpened distal tip of the needle when it's not in use. In one preferred embodiment, the port access needle device of the present invention includes a deformable retaining means for retaining or entrapping the sharpened end of a needle. In another embodiment, the safety port access needle device comprises a deformable retaining means that is an integral part of a safety casing. In another embodiment, the safety port access needle device of this invention has a deformable retaining means that include a needle tip gripping means. In yet another embodiment, the safety port access needle device comprises a deformable retaining means that is retrofitted to an existing safety casing during manufacturing. In one embodiment the deformable retaining means of the safety casing contains a deformable needle trap that is biased against or toward the needle. Prior to use, the port access needle device is in a fully retracted configuration and the needle tip is releasably retained in the needle trap. When using the port access needle device of the present invention, the top arm is pressed downward to transition the device from a retracted configuration to an operative configuration. While the manual force pushes the needle downward, the access needle is urged to start travel downward and against the interface of the deformable needle trap where the needle tip rests. The bent portion, or the curve, of the access needle generates tension and further pushes the needle trap away from the needle such to release the needle tip to allow further movement. The access needle continues to travel until the user stops pressing the top arm, or when the top arm rests on the base plate when the full operative position is reached. To remove the port access needle device after application, the top arm is pulled upward such that the port access needle device is transitioned from a fully operative configuration to a retracted configuration. During the configuration transition, the needle travels upward while pressing against the surface of the deformable needle trap and with the sharpened distal end advancing towards the needle trap. When the sharpened end of the needle reaches the needle trap, the interfacial tension between the needle trap and the needle releases and the needle tip is entrapped, retained, or locked, by the deformable needle trap. In one embodiment, the safety casing may further comprise a tether, or other limiting means, limiting the potential sliding movement of the needle tip when it's entrapped in a deformable needle trap.

[0016] In another aspect of the present invention, a method of reducing the incidence of or the severity of CBABSIs is provided. In general, the method comprises the steps of providing a port access needle device having means for viewing the needle insertion site. Preferably, the port access needle device includes a port access needle secured to a protective cover. Even more preferably, the protective cover includes a top arm operably attached to a bottom or base plate. In preferred forms, the attachment is pivotable or rotatable. Preferably, the base plate includes at least one, and preferably two side wings. The side wings are preferably formed of a flexible material or sponge and have an adhesive on one side. The bottom plate also preferably includes a padding material on one side thereof, and preferably on the same side as the adhesive when it is present on the side wings. In other preferred forms, the base plate has an oval shape with a length greater than its width. Preferably the base plate includes an opening therein such that when positioned on a patient's skin, a portion of the skin is exposed. Preferably the opening will be disposed between the two side wings and between the two ends of the device. Similarly, the padding material preferably includes a hole or opening therein. In some forms, the opening is similar in size and shape to the opening of the base plate while in other forms, it is smaller or larger than the opening of the base plate. In other preferred forms, an antiseptic is applied to the padding. The method can further comprise the step of securing the device to a patient's skin by pressing the side wings containing adhesive thereon against the skin. Once the device is securely positioned over the desired insertion site above the port-a-cath, the top arm is moved from a retracted position to an operative position, passing the needle through the opening of the bottom or base plate, through the skin of the patient at an insertion site, and eventually penetrating the port-a-cath such that the needle can deliver material to the portal of the port-a-cath. In preferred forms, at least a portion of the protective cover is formed so that the insertion site is visible from the outside. This can be done using clear plastic, transparent or translucent colored plastic, and the like. Thus, in preferred forms of the method, the method includes the step of visualizing the insertion site and if/when issues or symptoms resembling or indicating infection appear, the device can be removed and the infection treated sooner than possible with devices of the prior art. In preferred forms, due to the easy visualization of the insertion site, infections can be identified or visually detected and treated much quicker than using the devices and methods of the prior art. Preferably, the symptoms of infection are visually detected and/or identified within 2 days of becoming visible, more preferably within 1 day of becoming visible, still more preferably within 16 hours of becoming visible, even more preferably within 12 hours of becoming visible, still more preferably within 10 hours of becoming visible, more preferably within 8 hours of becoming visible, still more preferably within 6 hours of becoming visible, even more preferably within 4 hours of becoming visible, still more preferably within 2 hours of becoming visible, and most preferably within 1 hour or less of becoming visible or detectable by sight. Of course, once infection is detected, treatment should begin immediately or soon thereafter.

[0017] In another aspect of the present invention, a port access needle having a low profile or overall height when placed on the skin in the operative position is provided. Such a low profile will aid in access to the insertion site including areas with double lumens. Advantageously, the low profile design will also permit easier dressing application, when needed.

[0018] Other objects and benefits of this invention will become apparent from the description which follows hereinafter when read in conjunction with the figures that accompany it.

BRIEF DESCRIPTION OF FIGURES

[0019] Figure 1 is a front perspective view of the port access needle in a retracted configuration;

[0020] Fig. 2 is a side view of the port access needle in a retracted configuration, with the sharp end of the needle housed in the safety casing;

[0021] Fig. 3 is a top view of the port access needle in an operative configuration;

[0022] Fig. 4 is a front view of the port access needle in an operative configuration;

[0023] Fig. 5 is a side view of the port access needle in an operative configuration;

[0024] Fig. 6 is an illustration of implanted port system; and

[0025] Fig. 7 is an illustration of the port access needle accessing an arm-implanted port system. DETAILED DESCRIPTION OF THE INVENTION

[0026] Referring to FIGS 1-3, the port access needle device of the present invention comprises an access needle 1 having a sharpened distal end 11, a protective cover 2 which includes a top arm 21, a bottom plate 23, a safety casing 27, and a padding 3. The access needle 1 is mounted to the top arm 21 with the sharpened distal end 11 pointing away from the top arm 21 and towards the safety casing 27 and the bottom plate 23. The top arm 21 has side walls 22. The top arm 21 is operably connected to the bottom plate 23 via a pivot 24 extending upward from a first end of the bottom plate 23. The safety casing 27 is located at the second end of the bottom plate 23. A pair of opposed wing members 26 extend outwardly from the sides of the bottom plate 23. The bottom plate 23 has an opening 25 between the two ends of the bottom plate 23. Preferably the opening 25 is configured to contact or receive at least a portion of the top arm 21 side walls 22 to effectively close at least a portion of opening 25 when top arm 21 is pivoted into an operative position. The padding 3 has an opening 31 having matching size and position in some embodiments to the opening 25 of the bottom plate 23, while in other embodiments, padding 3 occupies more or less of opening 31.

[0027] Referring to FIGS. 4 and 5, when the user pushes the top arm 21 downward, the top arm 21 is rotated about the pivot 24 and the sharpened distal end 11 of the access needle 1 slides out of the safety casing 27 and travels through the opening 25 of the bottom plate 23 and the opening 31 of the padding 3 until the side walls 22 of the top arm rest on the bottom plate 23. When performing these steps in actual use, the access needle 1 penetrates the skin in order to access the implanted port system 40 (shown in FIG. 7).

[0028] Referring to FIG. 7, when the port access needle of the present invention is being used to access an implanted port system 40 as illustrated in FIG. 6, preferably the user can visualize the location of the implanted port by looking for the bump on the skin indicative of the port through the window area defined by the opening 25 and the opening 31. Alternatively, the user can locate the implanted port system 40 via tactile sensation. The user then places the padding 3 of the port access needle against the skin around the area where the port system is located, and adjusts the position of the port access needle if needed. Once the port access needle is placed at a determined location on the skin, the user can then push the pair of wings 26 using digits of the first hand to stabilize the port access needle device, and at the same time push the top arm 21 further towards the bottom plate 23 to release the sharpened distal end 11 of the access needle 1 from the safety casing using the second hand. The user pushes the top arm 21 until the sharpened distal end 11 of the access needle 1 touches the bottom of the portal chamber. The distance the needle 1 travels is equal or smaller than the maximum distance that the top arm 21 can travel.

[0029] When de-accessing or retracting the port access needle 1 from an implanted port, the fingers of the first hand remain on the wings 26 of the port access needle device when the user lifts the top arm 21 straight up until the sharpened distal end 11 of the access needle 1 returns to and is secure in its safety casing 27. The fully retracted port access needle device can then be disposed without the needle stick risk according to relevant protocols.

Claims

CLAIMS What is claimed is:

1. A port needle device comprising, a) an access needle (1) having a proximal end and sharpened distal end (11); b) a protective cover (2) securing the access needle (1), said protective cover having: a top arm (21) containing the access needle (1) and, a bottom plate (23) having a top side facing the top arm and an opposed bottom side, and an opening (25) in the bottom plate (23) sized to permit said access needle (1) to pass through said opening (25), and wherein said bottom plate (23) is pivotally connected to the top arm (21) at a first end; c) a pair of opposed side wings (26) attached to said bottom plate (23); and d) a padding disposed on the bottom side of said bottom plate (23).

2. The port needle device of claim 1, further comprising a safety casing (27) located near a second end of the bottom plate (23), wherein said safety casing (27) shields the distal end (11) of said access needle from unintended contact.

3. The port needle device of claim 2, wherein said safety casing (27) faces the access needle and the access needle slides against the safety casing when it transitions from a retracted position to an operative position.

4. The port access needle device of clam 1, further comprising a safety needle mechanism having a retaining means allowing the sharpened end of the needle trapped in or released from the safety casing when the top arm (21) pivotallly moves.

5. The port needle device of claim 1, wherein said padding (3) includes an antiseptic agent.

6. The port needle device of claim 1, wherein said side wings (26) include an adhesive disposed on the bottom side thereof.

7. The port needle device of claim 1, further comprising a designation on said device, wherein said designation indicates the size of the needle (1).

8. The port needle device of claim 1, wherein at least a portion of said protective cover (27) permits visualization of the area in said opening (25).

9. The port needle device of claim 1, wherein the top arm (21) rotatably transitions between a retracted configuration wherein the top arm (21) is pulled up and is at a starting angle relative to the bottom plate (23) and wherein the access needle (1) is retracted with the sharpened distal end (11) being above said opening (25), and an operative configuration wherein the top arm (21) is brought into proximity to the bottom plate (23) and is at an operative angle from about zero degrees to an angle smaller than the starting angle wherein the sharpened distal end (11) of said access needle (1) extends through said opening (25).

10. The port needle device of claim 1, wherein the padding (3) comprises a second opening matching the first opening (25) of the bottom plate (23).

11. The port needle device of claim 1 or 2, further comprising a safety needle mechanism, wherein said safety needle mechanism comprises a needle retaining means to trap the sharpened distal end (11) of the access needle (1).

12. The port needle device of claim 11, wherein the needle retaining means is a deformable needle trap that is biased against the port access needle (1).

13. The port needle device of claim 11, wherein the needle retaining means is an integral part of the safety casing. (27)

14. A method of accessing or exiting an implanted portal (40) in a patient comprising the steps of : a) locating the implanted portal (40); b) positioning the port access needle device of claim 1 above the implanted portal such that the port access needle 1) will penetrate the portal when the top arm (21) is pivoted to bring the top arm into proximity with the bottom plate (23); c) stabilizing the port access needle device against the patient's skin using said side wings (26); and d) pivoting said top arm (21) toward said bottom plate (23) such that the distal end of the needle (11) passes through said opening (25), pierces the patient's skin, and penetrates the implanted portal, thereby exiting the portal.

15. The method of claim 14, further comprising the step of pivoting said top arm (21) away from said bottom plate (23) such that the distal end of the needle (11) exits the portal (40), passes through said opening (25), and thereby deaccesses the portal.

16. A method of reducing the incidence of or severity of central line-associated blood stream infections (CLABSIs) comprising the steps of: a) using the port access needle device of claim 8 to access an implanted portal (40); b) inspecting the insertion site where the port access needle (1) enters the skin; c) identifying at least one symptom of infection during said inspecting step; and d) treating said infection.

17. The method of claim 16, wherein said port access needle device further comprises a transparent portion on either the bottom plate (23), the top cover (21), or both, and wherein said transparent portion permits the insertion site to be seen.

18. The method of claim 16, wherein said padding (3) on said port access needle device includes an antiseptic agent.

19. The method of claim 16, wherein the protective cover (2) includes a designation indicating the size of the port access needle.

20. The method of claim 16, wherein said symptom of infection is identified within 4 hours of becoming visible.