Blood Flash Indicator for a Catheter Insertion Device

Abstract

This application relates to a blood flash indicator for a catheter insertion device. The blood flash indicator includes a needle having a distal sharp tip with a distal end opening; a proximal portion including a first notch and a second notch in the sidewall of the needle, the first notch and the second notch being in fluid communication with the distal end opening via a needle lumen; and a translucent chamber surrounding the first notch and the second notch, the translucent chamber being sealed to the outer surface of the needle, wherein the catheter insertion device includes a needle hub having a longitudinally extending slot, and the translucent chamber of the blood flash indicator is disposed in the longitudinally extending slot.

Description

[0001] Divisional Information

[0002] This application is a divisional application of the patent application for invention with application number 202011105345.5 and invention title "Blood Control for a Catheter Insertion Device", which was filed on September 12, 2017. This patent application for invention is in turn a divisional application of the patent application for invention with application number 201780054901.0 and invention title "Blood Control for a Catheter Insertion Device", which was filed on September 12, 2017.

[0003] Cross - reference to Related Patent Applications

[0004] This patent application claims the benefit of U.S. Provisional Patent Application No. 62 / 393,531, titled "BLOOD CONTROL FOR A CATHETER INSERTION DEVICE", filed on September 12, 2016, the entire disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0005] This application relates to the field of medical devices, and more particularly to a blood flash indicator for a catheter insertion device. BACKGROUND ART

[0006] Currently, there is no blood flash indicator as described herein in the art for ensuring that a needle has correctly entered a vein or other desired blood-carrying blood vessel. SUMMARY OF THE INVENTION

[0007] Briefly, embodiments of the present invention relate to a blood flash indicator for a catheter insertion device, including a needle having a distal sharp tip with a distal end opening; a proximal portion including a first notch and a second notch in the sidewall of the needle, the first notch and the second notch being in fluid communication with the distal end opening via a needle lumen; and a translucent chamber surrounding the first notch and the second notch, the translucent chamber being sealed to the outer surface of the needle, wherein the catheter insertion device includes a needle hub having a longitudinally extending slot, and the translucent chamber of the blood flash indicator is disposed in the longitudinally extending slot.

[0008] In one embodiment, the longitudinally extending slot includes a plurality of shoulders configured to support the needle, wherein the proximal shoulder includes a proximal edge configured to prevent liquid adhesive from flowing out of the longitudinally extending slot when liquid adhesive is used to secure the needle in the longitudinally extending slot. In one embodiment, the needle hub further includes a radially extending ridge disposed near the proximal end of the needle hub, the radially extending ridge configured to support a spring of the catheter insertion device. In one embodiment, the translucent chamber of the blood flash indicator surrounds a portion of the needle. In one embodiment, a first notch is disposed distal to a second notch, toward the distal end of the translucent chamber. In one embodiment, the second notch is configured to provide an exit point for air in the translucent chamber to equalize air pressure and enable blood to continue entering the translucent chamber through the first notch. In one embodiment, the blood flash indicator further includes an additional notch that enables blood present in the needle lumen to travel proximally upward into the space between the outer surface of the needle and the inner surface of the catheter.

[0009] These and other features of the embodiments of the present invention will become more apparent from the following description and the appended claims, or may be learned by the practice of the embodiments of the present invention as shown below. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] A more particular description of the disclosure will be given by reference to specific embodiments of the disclosure shown in the drawings. It should be appreciated that these drawings only show typical embodiments of the invention and are not to be considered limiting of its scope. The exemplary embodiments of the invention will be described and illustrated in more specific and detailed manner by using the drawings, in which:

[0011] Figure 1A and Figure 1B is a perspective view of a catheter insertion device according to one embodiment;

[0012] Figure 2 is Figure 1A and Figure 1B is an exploded view of the catheter insertion device of

[0013] Figure 3 is a cross-sectional side view of a catheter according to one embodiment;

[0014] Figure 4 is Figure 3 a perspective view of the blood control component of the catheter of

[0015] Figure 5A and Figure 5B show various views of the blood control component of Figure 4 ;

[0016] Figures 6A to 6CShows various views of a blood control component for a catheter according to one embodiment;

[0017] Figures 7A to 7C Shows Figures 6A to 6C various views of the use of the catheter and the blood control catheter;

[0018] Figures 8A to 8F Shows Figure 1A and Figure 1B various views of the needle hub of the catheter insertion device;

[0019] Figure 9 is Figure 1A and Figure 1B a cross-sectional view of the flash indicator of the catheter insertion device;

[0020] Figure 10 is Figure 1A and Figure 1B a perspective view of the valve of the catheter insertion device; and

[0021] Figure 11 shows the isolation view of the blood control component of the valve of the catheter insertion device for puncturing Figure 1A and Figure 1B ; DETAILED DESCRIPTION

[0022] Now referring to the drawings, where like structures will have like reference numerals. It should be understood that the drawings are illustrative and schematic of exemplary embodiments of the present invention and are not a limitation of the present invention, nor are they necessarily drawn to scale.

[0023] For clarity, it should be understood that the term "proximal" refers to the direction relatively closer to the clinician using the device to be described herein, and the term "distal" refers to the direction relatively farther from the clinician. For example, the end of a catheter placed within a patient's body is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Additionally, as used herein (including in the claims), the terms "comprising," "having," and "with" shall have the same meaning as the term "including."

[0024] Generally speaking, embodiments of the present invention relate to a tool for assisting in placing a catheter or other tubular medical device into a patient. For example, catheters of various lengths are typically placed in a patient to establish access to the patient's vasculature and enable the infusion of drugs or the aspiration of body fluids. The catheter insertion tool described herein facilitates such catheter placement. It should be noted that although the discussion below focuses on the placement of a particular type and relatively short length of catheter, catheters of various types, sizes, and lengths can be inserted via this device, including peripheral intravenous intermediate or extended dwell catheters, PICC catheters, central venous catheters, etc. In one embodiment, a catheter having a length between about 1.25 inches and about 2.25 inches can be placed, but many other lengths are possible.

[0025] Figures 1A to 2 Various details of a catheter insertion tool (the "insertion tool" or "insertion device"), generally designated 10, are shown in accordance with one embodiment. As shown, the insertion tool 10 includes a housing 12, which itself may include a proximal housing portion 12A and a distal housing portion 12B. The housing 12 also includes an open distal end and may include a flat bottom to enable the insertion device 10 to rest flat on a surface without tipping. In another embodiment, the housing is integrally formed. In another embodiment, a top housing portion and a bottom housing portion may be employed, or more than two portions may be used. In the present embodiment, the housing is constructed of a thermoplastic such as polycarbonate and is translucent, but other configurations are also contemplated. The housing 12 defines a gripping surface 13 on either side of the housing, as Figure 1A and Figure 1B shown, to enable the insertion device 10 to be gripped by a user.

[0026] A needle hub 14 that supports a hollow needle 16 (which forms part of a needle assembly in one embodiment) is included within the housing 12. In the present embodiment, the needle hub 14 is fixed within a cavity 13 defined by the housing within the housing 12, but in another embodiment, the needle hub may be integrally formed with the housing.

[0027] As will be described in further detail below, the needle hub 14 includes a slot for receiving a portion of the needle 16 and a quantity of adhesive, such as a liquid or UV curable adhesive, to secure the needle in place within the needle hub. The needle 16 extends distally from the needle hub 14 so as to extend beyond the distal end of the distal housing portion 12B and terminate at its distal end 16B. A notch 18 is defined through the wall of the needle 16, near the distal end of the needle. During a catheter insertion procedure, the notch 18 enables blood to flow back out of the lumen defined by the hollow needle 16 once the hollow needle has entered the patient's vasculature. Thus, blood exiting the notch 18 can be observed by the clinician to confirm that the needle is properly placed within the vasculature, as will be further described below.

[0028] A catheter 42 including a catheter body 44 is removably disposed over a portion of a needle 16 that is external to a housing 12 such that the needle occupies a lumen of the catheter defined by the catheter body. The catheter body 44 extends distally from a hub 46 of the catheter 42 that is initially disposed adjacent an open distal end of a distal housing portion 12B, as Figure 1A and Figure 1B shown.

[0029] The insertion device 10 further includes a guidewire advancement assembly 20 for advancing a guidewire 22 through the needle and into a patient's vasculature after the needle 16 has entered a blood vessel. The guidewire 22 ( Figures 1A to 2 ) is prepositioned within the lumen of the needle 16. The guidewire advancement assembly 20 includes a guidewire rod 24 that selectively advances the guidewire 22 in a distal direction during use of the insertion device 10 such that a distal portion of the guidewire extends beyond a distal end 16B of the needle 16. In the present embodiment, a finger pad 28 of the guidewire lever 24 is slidably disposed on the housing 12 via a slot 32 such that a user's thumb and / or finger can selectively advance the guidewire 22 distally past the distal end 16B of the needle 16. Of course, other engagement schemes that convert a user input into guidewire movement may be used. In one embodiment, the guidewire 22 may include a guidewire support tube to provide additional stiffness to the guidewire and facilitate the distal advancement described above. In another embodiment, a proximal end of the guidewire may be attached at an anchor point on the interior of the housing 12 (or other fixed portion of the insertion device 10) and looped around a proximal portion of the guidewire lever 24 in a generally U-shaped configuration such that for each unit distance of movement of the finger pad 28, the distal end of the guidewire extends distally beyond the distal end 16B of the needle 16 by two unit distances. These and other modifications may thus be considered.

[0030] In one embodiment, a majority of the length of the guidewire comprises a metal alloy of nickel and titanium commonly referred to as nitinol, although other suitable guidewire materials may be employed.

[0031] Figure 1A and Figure 1B shows the catheter 42 removably attached to the insertion device 10 such that its catheter body 44 is disposed over a portion of the needle 16 that extends distally from the housing 12 such that the catheter is external to the insertion device housing. The catheter 42 in the present embodiment is held in place against the open distal end of the housing by a friction fit with one or more features disposed on the distal end of the housing. A tab 48 is included on the catheter hub 46 to assist a user in manually extending the catheter 42 distally during use.

[0032] Note that in one embodiment, the outer diameter (and / or other regions) of the needle 16 and the catheter body 44 are lubricated with silicone or other suitable lubricants to enhance the sliding of the catheter body relative to the needle and to facilitate insertion of the catheter into the patient.

[0033] The insertion device 10 includes a retraction system that is configured to selectively retract the needle 16 into the housing 12. Specifically, a spring element such as a coil spring 50 is disposed between the distal end of the inner lumen 13 of the housing 12 and a ridge 144 disposed at the proximal end of the needle hub 14. The spring 50 surrounds the needle hub 14, and the needle hub is slidable proximally within the cavity of the housing 12. The needle hub 14 is held in a distal position within the cavity of the housing 12, where the spring is held in a compressed configuration by a retraction button 52 disposed near the distal end of the housing 12. Manual pressing of the retraction button 52 releases the engagement of the retraction button with the needle hub 14, which in turn causes the spring 50 to expand, thereby moving the needle hub proximally within the cavity of the housing 12. This in turn retracts the needle 16 such that its distal end 16B retracts into the housing 12 and prevents inadvertent contact by the user. Note that other needle safety configurations may also be employed.

[0034] The use of the insertion device 10 for placing the catheter 42 in the patient's vasculature is described herein. The user holding the insertion device 10 first guides the distal portion of the needle 16 through the skin and into a subcutaneous blood vessel at a suitable insertion site. After confirming that the needle has entered the blood vessel, the guidewire advancement assembly 20 is actuated, where a finger pad 28 (disposed within a slot 32 defined in the housing 12) is advanced by the user's finger to advance distally a guidewire 22 ( Figure 1A ) initially disposed within the hollow needle 16. Note that the guidewire 22 is advanced distally by a guidewire lever 24 that is operatively attached to the slidable finger pad 28.

[0035] The distal advancement of the guidewire 22 continues until the finger pad 28 slides distally a predetermined distance such that a predetermined length of the guidewire 22 extends beyond the distal end of the needle 16, as Figure 1A and Figure 1B shown. This places the distal portion of the guidewire 22 within the blood vessel.

[0036] Once the guidewire lever 24 is fully extended distally by the sliding of the finger pad 28, which extends the guidewire 22 beyond the distal end 16B of the needle 16, the tab 48 of the catheter hub 46 is used to manually advance the catheter 42 distally, which causes the catheter body 44 to slide over the distal portions of the needle 16 and the guidewire 22 and enter the patient's vasculature via the insertion site. In accordance with this, it should be understood that in the present embodiment, the finger pad 28 serves as a first member for advancing the guidewire 22, while manual advancement is used to advance the catheter 42. In another embodiment, it should be understood that the finger pad 28 may also be used to deploy the catheter 42 distally into the blood vessel at least in part.

[0037] The catheter 42 is advanced distally until the catheter is properly positioned within the patient's blood vessel. Then, the user manually presses the retraction button 52 on the housing 12, which decompresses the spring 50 and retracts the needle hub 14, which in turn retracts the distal end 16B of the needle 16 into the housing 12 and prevents it from emerging again, thereby protecting the user from accidental needle sticks. Thus, this serves as an example of a needle safety component according to the present embodiment; other components may also be employed. At this time, the catheter 42 is physically separated from the housing 12. Now, at the appropriate location within the patient, the catheter 42 can be prepared for use and trimming according to standard procedures. Then the insertion device 10 can be discarded.

[0038] More specifically, Figure 2 A continuous blood flash indicator 80 is shown that can be used with the insertion device 10 according to one embodiment. The flash indicator 80 is used to indicate the presence of blood in the lumen of the needle 16 during use of the device 10, thereby ensuring that the needle has properly entered a vein or other desired blood-carrying blood vessel. As Figure 9 shown, the flash indicator 80 includes a translucent chamber 82 that is generally cylindrical, sealed at either end, and disposed around a portion of the needle 16 such that the needle projects from either sealed end. In the present embodiment, the chamber 82 of the flash indicator 80 is disposed in the slot 142 ( Figures 8A to 8F ) of the needle hub 14 within the housing 12, but it may also be disposed at other locations along the needle.

[0039] Two notches (a first notch 83 and a second notch 84) are defined in the needle 16 to provide fluid communication between the lumen of the needle and the interior of the flash indicator chamber. In one embodiment, the notches 83, 84 replace the notch 18 ( Figure 2), and in another embodiment, includes both of these notches in addition to notch 18. It should be understood that in one embodiment, the blood passage through notch 18 serves as an initial indicator that the distal end 16B of the needle has entered the vein, while the embodiment shown herein serves as an additional indicator to verify that the distal end of the needle remains in the vein after the initial entry. More details regarding the flash indicator 80 can be found in U.S. Patent Application No. 15 / 154,384, filed on May 13, 2016, entitled "Catheter Placement Device Including an Extensible Needle Safety Component", which is incorporated herein by reference in its entirety.

[0040] In this embodiment, the guide wire 22 passes through the lumen of the needle 16 to extend through the flash indicator 80. The first notch 83 is disposed distal to the second notch 84, toward the distal end of the chamber 82.

[0041] When vascular access is achieved through the distal end 16B of the needle 16, blood travels proximally upward between the inner surface of the needle and the outer surface of the guide wire 22 disposed in the lumen of the needle ( Figure 9 ). Upon reaching the relatively more distal first notch 83 defined in the needle 16, a portion of the blood will pass through the first notch and enter the chamber 82. When the chamber 82 is filled with blood, the user can observe the chamber through the translucent housing 12 of the insertion device 10 and observe the blood therein, thereby confirming that vascular access has been achieved. In another embodiment, the housing 12 can be configured such that the chamber 82 can be directly observed, for example, with no intervening structure interposed between the chamber and the user.

[0042] The second notch 84 serves as an exit point for air in the chamber 82 to equalize the air pressure and enable blood to continue entering the chamber through the first notch 83. It should be noted that in the absence of a blood passage through the second notch 84, the gap between the inner surface of the needle 16 and the outer surface of the guide wire 22 allows air rather than blood to pass therebetween, thereby equalizing the air pressure in the chamber. In this way, the flash indicator 80 is a continuous indicator such that blood continuously flows into the chamber 82 while the distal end 16B of the needle is disposed within a blood-carrying vessel.

[0043] It should be noted that the catheter insertion device 10 can include more than one flash indicator. In one embodiment and as described above, for example, a blood flash indicator 80 can be included, as well as another flash indicator, such as notch 18, which enables blood present in the lumen of the needle 16 to travel proximally upward into the space between the outer surface of the needle and the inner surface of the catheter 42.

[0044] Figure 3Shows various details of the blood control component 100 included in the catheter 42 according to one embodiment. As shown, the blood component 100 is slidably disposed within the cavity 46A of the catheter hub 46 and is configured to selectively enable fluid to flow through the catheter 42 together with the valve 102 also disposed within the catheter hub cavity. The valve 102 in this embodiment is a three - leaf valve that includes three lobes 102A defined by a plurality of slits 103, as Figure 10 shown, although other types of valves may also be employed.

[0045] Figures 4 to 5B Shows various details of the blood control component 100, which includes an elongated body 104 extending between a proximal end 104A and a distal end 104B and defining a central conduit 106 through which fluid can flow. A plurality of ribs 110 are disposed on the outer surface of the body 104 such that the ribs longitudinally extend from the proximal side past the proximal end 104A of the body to its distal end 104B. Each rib 110 extends radially from the body 104 to define a shaped profile along its longitudinal length. The body 104 and the ribs 110 contribute to generally defining the blood control component 100 as a conical shape. In other embodiments, a shape deviating from the conical shape may also be employed.

[0046] Each rib 110 also defines a notch 112 positioned intermediate along the longitudinal length of the rib, and a protrusion 114 at the proximal end of the rib. As Figure 3 shown, the notch 112 of each rib 110 receives a portion of an annular ridge 120 defined on the inner surface of the catheter hub cavity 46A to hold the blood control component 100 in place within the cavity prior to actuation. Accordingly, when the blood control component 100 is actuated, the protrusion 114 of each rib 110 engages the annular ridge 120 to prevent its further distal movement beyond its intended travel length. The body 104 defines channels 126 between adjacent ribs 110, thereby providing four fluid flow channels in the shown embodiment. It should be noted that in one embodiment, one or more ribs 110 may be offset along their longitudinal length such that the proximal portion of the rib including the protrusion 114 is not longitudinally aligned with the more distal portion of the rib (as Figure 5A and Figure 5B shown), but is circumferentially offset from the more distal portion of the rib.

[0047] Figures 6A to 6C Shows details of the blood control component 100 according to another embodiment, where the body 104 defines a plurality of channels 126 disposed around the conduit 106. An intermediate annular shoulder 128 is also defined by the body 104.

[0048] Figures 7A to 7C Shows Figures 6A to 6Cthe various operating phases of the blood control component 100, although the principles described herein also apply to Figures 4 to 5B the embodiments shown in Figure 7A and Figure 7B show the blood control component 100 in a relatively proximal position (also referred to herein as the unactuated state), where the annular ridge 120 is received within the notch 112 of each rib 110 of the blood control component (beneath the shoulder 128). In this position, the distal end 104B of the body 104 does not project through the valve 102 located distally of the blood control component, and thus no fluid can pass through the catheter 42 as needed. Accordingly, the valve 102 in the closed position prevents blood from leaking through the catheter 42, for example when the catheter has been placed within a patient but has not been externally connected to the catheter hub 46.

[0049] In contrast, Figure 7C shows the blood control component 100 in a relatively distal position (also referred to herein as the actuated state), where the blood control component has been distally advanced (such as by inserting a male luer connector into the catheter hub 46) such that its distal end 104B has passed through the leaflets 102A of the valve 102, thereby providing a fluid path through the valve via the catheter 106 of the blood control component. Further distal advancement of the blood control component 100 is prevented by the engagement of the protrusion 114 with the annular ridge 120. As described above, the distal movement of the blood control component 100 is caused by the insertion of a luer connector or other device that can be operably connected to the catheter hub 46 into the catheter hub cavity 46A.

[0050] According to the present embodiment, the blood control component 100 is configured to eliminate the trapped region between the blood control component and the valve 102 after the blood control component pierces the valve in its actuated state. Specifically, and with respect to Figures 4 to 5B the embodiment shown in Figure 11 when the blood control component pierces the valve, the ribs 110 cause additional deformation of the leaflets 102A of the valve 102, as shown in

[0051] Note that, in the present embodiment, the outer termination points of each slit 103 forming the lobule 102A define staggered termination points, as Figure 11 shown. It should also be noted that the ribs described herein are only one example of one or more extending surfaces, and the one or more extending surfaces may be included in the blood control component so that additional fluid flow channels can be defined on the outer surface of the blood control component, enabling fluid to flow around the outside of the blood control component when the blood control component pierces the valve. Examples of other extending surfaces include bumps, annular surfaces, fins, etc. Thus, these and other embodiments are contemplated.

[0052] Figures 6A to 6C The operation of the blood control component 100 of Figures 6A to 6C is similar to the operation of the blood control component described above in connection with Figures 4 to 5B wherein the channel 126 provides fluid flow in addition to the catheter 106 to prevent fluid flow stagnation between the blood control component 100 and the valve 102.

[0053] Figures 8A to 8F Various details of the aforementioned needle hub 14 of the insertion device 10 are shown, which insertion device includes an elongate body 140 that extends between a proximal end 140A and a distal end 140B. The slot 142 extends longitudinally along the length of the body 140 and is sized to receive a portion of the length of the needle 16 therein. As described above, the ridge 144 is included on the proximal end 140A of the needle hub and provides a surface against which the spring 50 can retract the needle hub and attach the needle 16 to the cavity of the housing 12. The slot 142 defines a volume 146 within which the aforementioned flash indicator 80 can be received.

[0054] Note that the slot 142 is configured such that needles of different sizes can be received therein and fixed therein. To this end, the slot 142 includes three shoulders 148 to support the needle 16 within the slot 142. The shape of the proximal edge of not each shoulder 148 is relatively inclined to prevent liquid epoxy adhesive placed in the slot 142 near the shoulder from overflowing for fixing the needle 16 within the slot.

[0055] Embodiments of the present invention may be embodied in other specific forms without departing from the substance of the present disclosure. The embodiments are to be considered in all respects only as illustrative and not restrictive. Thus, the scope of these embodiments is indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims will be embraced within the scope of the claims.

Claims

1. A blood flash indicator for a catheter insertion device, comprising: a needle, the needle comprising: a distal sharp tip, the distal sharp tip comprising a distal end opening; a proximal portion, the proximal portion comprising a first notch and a second notch in the sidewall of the needle, the first notch and the second notch being in fluid communication with the distal end opening via a needle lumen; and a translucent chamber surrounding the first notch and the second notch, the translucent chamber being sealed to the outer surface of the needle, wherein the catheter insertion device comprises a needle hub, the needle hub comprising a longitudinally extending slot, the translucent chamber of the blood flash indicator being disposed in the longitudinally extending slot, wherein the second notch is configured to provide an exit point for air in the translucent chamber to equalize air pressure and enable blood to continue to enter the translucent chamber through the first notch without blood passing through the second notch.

2. The blood flash indicator according to claim 1, wherein the longitudinally extending slot comprises a plurality of shoulders configured to support the needle, wherein a proximal shoulder comprises a proximal edge configured to prevent liquid adhesive from flowing out of the longitudinally extending slot when the liquid adhesive is used to secure the needle in the longitudinally extending slot.

3. The blood flash indicator according to claim 1, wherein the needle hub further comprises a radially extending ridge disposed near a proximal end of the needle hub, the radially extending ridge being configured to support a spring of the catheter insertion device.

4. The blood flash indicator according to claim 1, wherein the translucent chamber of the blood flash indicator surrounds a portion of the needle.

5. The blood flash indicator according to claim 1, wherein the first notch is disposed distal to the second notch, toward a distal end of the translucent chamber.

6. The blood flash indicator according to claim 1, further comprising an additional notch that enables blood present in the needle lumen to travel proximally upward into a space between an outer surface of the needle and an inner surface of a catheter.

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