Guidewire management devices and methods

Abstract

Disclosed herein are guidewire management devices and systems thereof. The guidewire management device can have a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured to route the guidewire distally out of the guidewire management device. The first sleeve can be further configured to route the guidewire proximally into the guidewire management device. A second sleeve can be located proximal to the first sleeve within the guidewire management device. The second sleeve can be configured to cooperate with the first sleeve to route the guidewire. At least a portion of the length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.

Description

[Technical Field]

[0001]

[0001] This application claims the benefit of priority to U.S. Patent Application No. 62 / 989,371, filed March 13, 2020, which is incorporated herein by reference in its entirety. [Background technology]

[0002]

[0002] Catheters are typically placed within a patient's blood vessels using the Seldinger technique, which involves inserting a hollow needle into the blood vessel, inserting a guidewire through the needle, advancing the guidewire into the blood vessel, and removing the needle from the blood vessel, leaving the guidewire in place. A catheter is then advanced over the guidewire until it is properly positioned in the patient's vasculature. The guidewire is then removed from the patient. Summary of the Invention [Problem to be solved by the invention]

[0003]

[0003] Guidewires used in accordance with the Seldinger technique are typically packaged in a coiled tubing dispenser to maintain the guidewire in a sterile condition and reduce the hassle of handling the guidewire. However, inserting such a guidewire from the dispenser into a hollow needle requires two hands. Specifically, one hand is required to hold both the needle and the engagement piece configured to guide the guidewire into the needle, while the other hand is required to grasp the guidewire and guide it from the dispenser into the needle. Increased handling of the guidewire increases the opportunity for the guidewire to become contaminated or damaged. In view of the above, there is a need for better guidewire management during medical procedures, such as those requiring the Seldinger technique. [Means for solving the problem]

[0004]

[0004] Disclosed herein are guidewire management devices and methods that address the above.

[0005] Disclosed herein is a guidewire management device, which in some embodiments includes a guidewire, a first sleeve, and a second sleeve. The first sleeve is configured to route the guidewire distally out of the guidewire management device. The first sleeve is further configured to route the guidewire proximally into the guidewire management device. A second sleeve is located proximal to the first sleeve within the guidewire management device. The second sleeve is configured to route the guidewire in cooperation with the first sleeve. At least a portion of the length of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain sterility of the guidewire. The sterile barrier is a splittable casing configured to separate from the guidewire while routing the guidewire distally out of the guidewire management device.

[0005]

[0006] In some embodiments, the first sleeve has a distal portion configured as a male connector with a luer taper for connecting the first sleeve to a complementary female connector.

[0006]

[0007] In some embodiments, the first sleeve is configured to straighten the guidewire as it is advanced proximally into the guidewire management device.

[0007]

[0008] In some embodiments, the first sleeve has a seal configured to prevent fluid from entering or escaping from the guidewire management device when the guidewire is advanced proximally into the guidewire management device.

[0008]

[0009] In some embodiments, the first sleeve has a proximal portion with a bore configured to receive the distal portion of the sterility barrier.

[0010] In some embodiments, the second sleeve has a distal portion having a bore configured to receive the proximal portion of the sterility barrier.

[0009]

[0011] In some embodiments, the second sleeve has a proximal portion with another bore configured to prevent the end of the guidewire from passing completely through the second sleeve.

[0012] In some embodiments, the guidewire has a distal portion with a J-shaped tip that is configured to straighten when the tip of the guidewire enters the first sleeve as the guidewire is advanced proximally into the guidewire management device.

[0010]

[0013] In some embodiments, the guidewire has a proximal portion with a bulbous end configured to prevent the guidewire from passing completely through the second sleeve.

[0014] In some embodiments, the guidewire management device is configured to reposition the splittable casing over the guidewire while advancing the guidewire proximally into the guidewire management device.

[0011]

[0015] Further disclosed herein is a guidewire management device, which in some embodiments includes a handle, a guidewire, a first sleeve formed within a distal portion of the handle, a second sleeve formed within a proximal portion of the handle, and a thumbwheel disposed beneath the guidewire between the first and second sleeves. At least a portion of the length of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain sterility of the guidewire. The sterile barrier is a splittable casing configured to separate the guidewire from the guidewire while routing the guidewire distally and out of the guidewire management device. The thumbwheel is configured to assist in routing the guidewire distally through the first sleeve and out of the guidewire management device. The thumbwheel is further configured to assist in routing the guidewire proximally through the first sleeve and into the guidewire management device.

[0012]

[0016] In some embodiments, the first sleeve has a distal portion configured as a male connector with a luer taper for connecting the first sleeve to a complementary female connector.

[0013]

[0017] In some embodiments, the first sleeve is configured to straighten the J-shaped tip in the distal portion of the guidewire as the tip of the guidewire enters the first sleeve when the guidewire is advanced proximally into the guidewire management device.

[0014]

[0018] In some embodiments, the second sleeve has a proximal portion having a bore with a narrowed portion configured to capture the bulbous end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

[0015]

[0019] In some embodiments, the splittable casing is over the entire guidewire except within or distal to the first sleeve.

[0020] In some embodiments, the guidewire management device further includes a guidewire conduit coupled to the second sleeve and a casing conduit coupled to both the first split sleeve in the distal portion of the handle and the second split sleeve in the proximal portion of the handle. The guidewire conduit is configured to route the guidewire distally into the second sleeve. The casing conduit is configured to collect a splittable casing therein that separates the guidewire from the guidewire while routing the guidewire distally out of the guidewire management device.

[0016]

[0021] In some embodiments, the handle has a channel configured to hold the guidewire conduit therein when the guidewire conduit is in a coiled configuration.

[0022] In some embodiments, the guidewire management device further includes a guidewire-casing conduit coupled to both the second sleeve and the first split sleeve within the distal portion of the handle, the guidewire-casing conduit configured to route the guidewire distally into the second sleeve, and the guidewire-casing conduit further configured to receive a splittable casing therein via the first split sleeve that separates the guidewire from the guidewire while routing the guidewire distally out of the guidewire management device.

[0017]

[0023] In some embodiments, the distal end of the splittable casing that separates from the guidewire is configured to track the proximal end of the guidewire around the guidewire-casing conduit while routing the guidewire distally and out of the guidewire management device.

[0018]

[0024] In some embodiments, the handle has a channel configured to hold the guidewire-casing conduit therein when the guidewire-casing conduit is in a coiled configuration.

[0019]

[0025] In some embodiments, the guidewire management device further includes a flexible membrane extending from a distal portion of the handle over the thumbwheel to a proximal portion of the handle, the flexible membrane configured to be pressed downward against the thumbwheel to either route the guidewire distally out of the guidewire management device or route the guidewire proximally into the guidewire management device.

[0020]

[0026] These and other features of the concepts presented herein will become apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which more particularly describe particular embodiments of the concepts presented herein. Additionally, this application is related to U.S. Patent Application No. 17 / 079,320, filed October 23, 2020, which is incorporated herein by reference in its entirety. [Brief explanation of the drawings]

[0021] [Figure 1]

[0027] FIG. 1 is an isometric view illustrating a first guidewire management device according to some embodiments. [Figure 2]

[0028] 1A-1C are longitudinal cross-sectional views illustrating a first guidewire management device according to some embodiments. [Figure 3]

[0029] FIG. 10 is an isometric view of a second guidewire management device according to some embodiments. [Figure 4]

[0030] 10A-10C are longitudinal cross-sectional views illustrating a second guidewire management device according to some embodiments. [Figure 5]

[0031] FIG. 10 is a detailed view showing the bulbous end of the guidewire distal to the plug in the guidewire conduit according to some embodiments. [Figure 6]

[0032] FIG. 10 is a side view illustrating a third guidewire management device according to some embodiments. [Figure 7]

[0033] FIG. 10 is an isometric view of a handle of a fourth guidewire management device according to some embodiments. [Figure 8]

[0034] 10A-10C are longitudinal cross-sectional views illustrating a fourth guidewire management device according to some embodiments. [Figure 9]

[0035] FIG. 10 is a side view illustrating a handle of a fifth guidewire management device according to some embodiments. [Figure 10]

[0036] FIG. 10 illustrates a handle of a fifth guidewire management device with the guidewire partially advanced out of the guidewire management device, according to some embodiments. [Figure 11]

[0037] 11 shows the handle of a fifth guidewire management device with the guidewire partially advanced further out of the guidewire management device than shown in FIG. 10. [Figure 12]

[0038] FIG. 10 is a side view illustrating a handle of a sixth guidewire management device according to some embodiments. [Figure 13]

[0039] FIG. 10 is an isometric view of a seventh guidewire management device according to some embodiments. [Figure 14]

[0040] FIG. 10 is a side view illustrating a seventh guidewire management device according to some embodiments. [Figure 15]

[0041] FIG. 10 is an isometric view of an eighth guidewire management device according to some embodiments. [Figure 16]

[0042] FIG. 10 is a side view illustrating an eighth guidewire management device according to some embodiments. [Figure 17]

[0043] FIG. 10 is a side view illustrating an eighth guidewire management device coupled to a catheter assembly, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0022]

[0044] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. Furthermore, it should be understood that the specific embodiments disclosed herein may have features that can be readily separated from the specific embodiment and that can optionally be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0023]

[0045] Furthermore, with regard to the terms used herein, it should be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify various features or steps within a group of features or steps, and do not provide a definitive or numerical limit on a sequence. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, nor are particular embodiments having such features or steps necessarily limited to only these three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "rear" are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such designations are used to reflect, for example, a relative location, relative orientation, or relative direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0024]

[0046] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be closest to the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be closest to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be closest to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context dictates otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or the terminal-most length of the catheter.

[0025]

[0047] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a clinician when the catheter is used with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context dictates otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or the terminal-most length of the catheter.

[0026]

[0048] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0049] As noted above, there is a need for better guidewire management in medical procedures, such as those requiring the Seldinger technique. Disclosed herein are guidewire management devices and methods that address the above. Guidewire Management Device

[0050] 1-16 illustrate various guidewire management devices, namely, guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500. For ease of explanation, the following description will first highlight features that guidewire management devices 100, 300, 600, and 700 have in common with each other and with many of the other guidewire management devices described herein. These features may be indicated among the various guidewire management devices by the same reference numeral (e.g., guidewire 102), similar reference numerals (where the reference numerals differ in prefix to reflect the figure or embodiment associated with those features, e.g., first sleeve 110, first sleeve 610, or first sleeve 710), descriptions, or combinations thereof. Indeed, common features may be similarly described among any group of guidewire management devices of the various guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500. After an initial description of guidewire management devices 100, 300, 600, and 700, guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500 will be described below individually or collectively with respect to some of their unique features.

[0027]

[0051] As shown, guidewire management device 100, 300, 600, or 700 has a guidewire 102, a first sleeve 110, 610, or 710, and a second sleeve 120, 620, or 720.

[0028]

[0052] The first sleeve 110, 610, or 710 is configured to have a lumen (i.e., an inner cavity) for feeding or advancing the guidewire 102 distally and out of the guidewire management device 100, 300, 600, or 700. The first sleeve 110, 610, or 710 has a distal portion configured as a male connector with a Luer taper for connecting the first sleeve 110, 610, or 710 to a complementary female connector, such as a connector on the hub of a hollow needle or catheter. The male connector is configured such that when mated with such a complementary female connector on, for example, the catheter, guidewire management device 100, 300, 600, or 700 forms a single unit with the catheter, thereby allowing the single unit to be held in one hand for guidewire management (e.g., feeding guidewire 102 distally out of guidewire management device 100, 300, 600, or 700 and into the catheter). (See FIG. 17.) First sleeve 110, 610, or 710 also has a proximal portion having a bore (i.e., hole) 112, 612 (not shown), or 712, and the lumen of first sleeve 110, 610, or 710 opens to the interior of this bore. The bore 112, 612, or 712 is configured to accommodate or receive the distal portion of the sterile barrier 104 or 304 when the guidewire 102 is advanced distally and out of the guidewire management device 100, 300, 600, or 700.

[0029]

[0053] First sleeve 110, 610, or 710 is further configured to advance or retract guidewire 102 proximally into guidewire management device 100, 300, 600, or 700. First sleeve 110, 610, or 710 is configured to straighten guidewire 102 (e.g., a J-shaped tip of the guidewire) when advancing guidewire 102 proximally into guidewire management device 100, 300, 600, or 700. (See FIGS. 7 and 8 for the J-shaped tip of guidewire 102 according to some embodiments.) First sleeve 110, 610, or 710 can have a seal, such as an “O” ring 114, 614 (not shown), or 714, configured to prevent fluid (e.g., blood) from entering guidewire management device 100, 300, 600, or 700 as the guidewire is advanced proximally into guidewire management device 100, 300, 600, or 700. The seal, such as “O” ring 114, 614, or 714, is further configured to prevent fluid (e.g., air) from leaking out of guidewire management device 100, 300, 600, or 700 as the guidewire is advanced proximally into guidewire management device 100, 300, 600, or 700, thereby minimizing or eliminating the risk of air embolism.

[0030]

[0054] A second sleeve 120, 620, or 720 is proximal to the first sleeve 110, 610, or 710 within the guidewire management device 100, 300, 600, or 700, such that at least a partial length of the guidewire 102 extends between the first sleeve 110, 610, or 710 and the second sleeve 120, 620, or 720. This at least a partial length of the guidewire 102 extending between the first sleeve 110, 610, or 710 and the second sleeve 120, 620, or 720 is disposed within the sterile barrier 104 or 304.

[0031]

[0055] The second sleeve 120, 620, or 720 is configured with a lumen for routing the guidewire 102 in cooperation with the first sleeve 110, 610, or 710, such as routing the guidewire 102 distally and out of the guidewire management device 100, 300, 600, or 700. The second sleeve 120, 620, or 720 has a proximal portion optionally having a bore 122, and the lumen of the second sleeve 120, 620, or 720 opens to the interior of this bore. For example, the second sleeve 120 has a proximal portion having a bore 122, while the second sleeve 620 or 720 has a proximal portion without such a bore. Whether or not the second sleeve 120, 620, or 720 has such a bore, the second sleeve 120, 620, or 720 may further have a constriction 124, recess 724, or similar stopping means for stopping the end of the guidewire 102, such as its bulbous end or slug end, from passing completely through the second sleeve 120, 620, or 720 as the guidewire 102 is advanced distally out of the guidewire management device 100, 300, 600, or 700. Because the narrowed portion 124, recess 724, or similar stopping means is configured to stop the end of the guidewire 102 from passing completely through the second sleeve 120, 620, or 720, the narrowed portion 124, recess 724, or similar stopping means is further configured to stop the guidewire from passing completely through the guidewire management device 100, 300, 600, or 700 and into the patient (where the guidewire 102 may be lost).

[0032]

[0056] Second sleeve 120, 620, or 720 is further configured to cooperate with first sleeve 110, 610, or 710 to route guidewire 102 proximally into guidewire management device 100, 300, 600, or 700. Second sleeve 120, 620, 720 has a distal portion with bore 126, 626 (not shown), or 726, into which the lumen of second sleeve 120, 620, or 720 opens. Bore 126, 626, or 726 is configured to house or receive the proximal portion of sterile barrier 104 or 304 when guidewire 102 is routed proximally into guidewire management device 100, 300, 600, or 700.

[0033]

[0057] Guidewire 102 has a distal portion and a proximal portion.

[0058] The distal portion of guidewire 102 can have a J-shaped tip configured to straighten the tip of guidewire 102 as it enters first sleeve 110, 610, or 710 when guidewire 102 is advanced proximally into guidewire management device 100, 300, 600, or 700. When guidewire 102 is advanced distally out of guidewire management device 100, 300, 600, or 700, the J-shaped tip is configured to reform the "J" shape when released from the stenosis (e.g., first sleeve 110, 610, or 710). When first sleeve 110, 610, or 710 is connected to a complementary female connector, such as a connector on the hub of a hollow needle, the tip of guidewire 102 does not reform the "J" shape until the tip distally passes over the needle, such as in a blood vessel.

[0034]

[0059] The proximal portion of the guidewire 102 can have a bulbous end configured to stop the guidewire 102 from passing completely through the second sleeve 120, 620, or 720 by a narrowed portion 124, recess 724, or similar stopping means when the guidewire 102 is advanced distally and out of the guidewire management device 100, 300, 600, or 700.

[0035]

[0060] Sterility barrier 104 or 304 is configured to maintain the sterility of guidewire 102 while it is disposed therein. Importantly, the guidewire never needs to be touched by the clinician during the procedure, thereby maintaining the sterility of guidewire 102 and further ensuring that the clinician does not come into contact with bodily fluids.

[0036]

[0061] Sterility barrier 104 is a pleated bag. Sterility barrier 104 or bag 104 is configured to unpleat when pulled from second sleeve 120 of guidewire management device 100 or through second sleeve 620 or 720 of guidewire management device 600 or 700 while routing guidewire 102 distally and out of guidewire management device 100, 600, or 700. Bag 104 is further configured to pleat when inserted into first sleeve 110, 610, or 710 while routing guidewire 102 distally and out of guidewire management device 100, 600, or 700. Similarly, bag 104 is configured to unpleat when pulled from first sleeve 110, 610, or 710 while routing guidewire 102 proximally and into guidewire management device 100, 600, or 700. Bag 104 is further configured to pleat when inserted into second sleeve 120 of guidewire management device 100 or when passing through second sleeve 620 or 720 of guidewire management device 600 or 700 while advancing guidewire 102 proximally into guidewire management device 100, 600, or 700.

[0037]

[0062] Advantageously, in guidewire management devices such as guidewire management devices 600 and 700, the combination of a partial length of bag 104 and its sealed or valved end is configured to stop the end (bulbed end) of guidewire 102 from passing through what would otherwise be an opening in the proximal end of bag 104. Stopping the end of guidewire 102 from passing through such an opening prevents the tip of guidewire 102 from passing completely through first sleeve 110 and reforming the J-shaped tip as guidewire 102 is advanced proximally into guidewire management device 600 or 700.

[0038]

[0063] Described below are methods for delivering or advancing guidewire 102 distally out of guidewire management device 100, 600, or 700. Further described below are methods for delivering or retracting guidewire 102 proximally into guidewire management device 100, 600, or 700.

[0039]

[0064] Sterility barrier 304 is a bellows boot. Sterility barrier 304, or boot 304, is configured to repeatedly stretch from an equilibrium state and relax back to the equilibrium state while advancing guidewire 102 distally and out of guidewire management device 300. Similarly, boot 304 is configured to repeatedly stretch from an equilibrium state and relax back to the equilibrium state while advancing guidewire 102 proximally and into guidewire management device 300.

[0040]

[0065] Below, methods are described for delivering or advancing guidewire 102 distally and out of guidewire management device 300. Further below, methods are described for delivering or retracting guidewire 102 proximally and into guidewire management device 300.

[0041]

[0066] Although not shown for any of guidewire management devices 100, 300, 600, and 700, sterility barrier 104 or 304 may alternatively be, for example, a splittable casing 904 over the entirety of guidewire 102 or over at least a majority of guidewire 102 except within or distal to first sleeve 110, 610, or 710. Splittable casing 904 is configured to separate from guidewire 102 while routing guidewire 102 distally and out of the guidewire management device. (See, e.g., guidewire management devices 900, 1200, 1300, and 1500.) Some of the guidewire management devices described above (e.g., guidewire management devices 1300 and 1500) are configured to insert guidewire 102 into splittable casing 904 while routing guidewire 102 proximally and into the guidewire management device. Dividable casing 904 can have scale markings thereon configured to indicate the length of a portion of guidewire 102 from the distal end of guidewire 102 .

[0042]

[0067] 1-4 to illustrate at least some of the unique features of guidewire management devices 100 and 300, guidewire management devices 100 and 300 include a guidewire 102, a frame 140 having a pair of tubular rails 142, a guidewire conduit 150 threaded through the pair of tubular rails 142, a first sleeve 110 mounted on the struts between the rails of the pair of tubular rails 142, and a second sleeve 120 mounted on the struts proximal to first sleeve 110 and between the rails of the pair of tubular rails 142. At least a portion of guidewire 102 is disposed within guidewire conduit 150.

[0043]

[0068] Guidewire conduit 150 may be opaque or translucent, depending on the polymeric material selected. If guidewire conduit 150 is translucent, guidewire conduit 150 is configured to allow visualization of guidewire 102 while routing guidewire 102 distally out of guidewire management device 100 or 300 or while routing guidewire 102 proximally into guidewire management device 100 or 300.

[0044]

[0069] FIG. 5 shows the bulbous end of guidewire 102 distal to plug 152 within guidewire conduit 150, according to some embodiments.

[0070] Guidewire conduit 150 has a proximal portion with a plug 152 configured to stop the bulbous end of guidewire 102 from passing through what would otherwise be an opening in the proximal end of guidewire conduit 150. Alternatively, plug 152 is simply a constricted portion of guidewire conduit 150, which has a similar effect. Stopping the bulbous end of guidewire 102 from passing through such an opening prevents the tip of guidewire 102 from passing completely through first sleeve 110 and reforming the J-shaped tip as guidewire 102 is advanced proximally into guidewire management device 100 or 300.

[0045]

[0071] 6-16 to describe at least some of the unique features of guidewire management devices 600, 700, 900, 1200, 1300, and 1500, guidewire management device 600, 700, 900, 1200, 1300, or 1500 includes a handle 640, 740, 940, 1240, 1340, or 1540, a guidewire 102, and a first sleeve 610, 710, 910, 1240, 1340, or 1540 formed within a distal portion of handle 640, 740, 940, 1240, 1340, or 1540. 10, 1310, or 1510, a second sleeve 620, 720, 920, 1220, 1320, or 1520 formed in a proximal portion of the handle 640, 740, 940, 1240, 1340, or 1540, and a thumbwheel 642, 742, 942, 1242, 1342, or 1542 disposed under the guidewire 102 between the first sleeve 610, 710, 910, 1210, 1310, or 1510 and the second sleeve 620, 720, 920, 1220, 1320, or 1520.

[0046]

[0072] Handle 640, 740, 940, 1240, 1340, or 1540 is ambidextrous, as it is configured to be held in either the right or left hand of a clinician. Additionally, handle 640, 740, 940, 1240, 1340, or 1540 is configured to be held in at least two configurations. The first configuration, in which handle 640, 740, 940, 1240, 1340, or 1540 is held by a clinician in a manner such as a person might hold the handle of a hammer, is the general configuration for handling guidewire management device 600, 700, 900, 1200, 1300, or 1500. When the clinician repositions their thumb over thumbwheel 642, 742, 942, 1242, 1342, or 1542, the second configuration is an operable configuration for advancing guidewire 102 out of or retracting guidewire 102 into guidewire management device 600, 700, 900, 1200, 1300, or 1500. Notwithstanding the above, some clinicians may find it comfortable to hold handle 640, 740, 940, 1240, 1340, or 1540 in a manner similar to that which a person might use to hold the barrel of a flashlight, thereby allowing access to both the first and second configurations with reduced hand movement.

[0047]

[0073] Handle 640, 1340, or 1540 has a channel 641, 1341, or 1541 configured to hold a conduit therein. As described below, the conduit may be, for example, guidewire conduit 1350 of guidewire management device 1300 or guidewire-casing conduit 1550 of guidewire management device 1500. Advantageously, this channel can hold the conduit in a coiled configuration, thereby allowing for packing of otherwise elongated conduits into a compact space. While only handles 640, 1340, and 1540 with channels are shown, any of handles 740, 940, and 1240 can have a channel configured to hold a conduit. Additionally, handle 640, 1340, or 1540 need not have channel 641, 1341, or 1541.

[0048]

[0074] Although there may be possible differences in one or more design elements, the first sleeves 910, 1210, 1310, or 1510 are similar to the first sleeves 110, 610, or 710 described above. Accordingly, the descriptions provided above for the first sleeves 110, 610, and 710 should be understood to extend to the first sleeves 910, 1210, 1310, and 1510 as if they were included in the descriptions of the first sleeves 110, 610, and 710.

[0049]

[0075] Although there may be possible differences in one or more design elements, second sleeve 920, 1220, 1320, or 1520 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeves 120, 620, and 720 should be understood to extend to second sleeves 920, 1220, 1320, and 1520 as if they were included in the descriptions of second sleeves 120, 620, and 720.

[0050]

[0076] The thumbwheel 642, 742, 942, 1242, 1342, or 1542 may be rotatably mounted on an axle fixedly coupled to each side of the handle 640, 740, 940, 1240, 1340, or 1540, such that the thumbwheel 642, 742, 942, 1242, 1342, or 1542 rotates relative to both the axle and the handle 640, 740, 940, 1240, 1340, or 1540. Alternatively, the thumbwheel 642, 742, 942, 1242, 1342, or 1542 can have an axle (e.g., as a single piece) or can be fixedly mounted on an axle that is further rotatably coupled to each side of the handle 640, 740, 940, 1240, 1340, or 1540, such that the combination of the thumbwheel 642, 742, 942, 1242, 1342, or 1542 and the axle rotates relative to the handle 640, 740, 940, 1240, 1340, or 1540. Thumbwheel 642, 742, 942, 1242, 1342, or 1542 is configured to assist in routing guidewire 102 distally through first sleeve 610, 710, 910, 1210, 1310, or 1510 and out of guidewire management device 600, 700, 900, 1200, 1300, or 1500. Thumbwheel 642, 742, 942, 1242, 1342, or 1542 is further configured to assist in routing guidewire 102 proximally through first sleeve 610, 710, 910, 1210, 1310, or 1510 and into guidewire management device 600, 700, 900, 1200, 1300, or 1500.

[0051]

[0077] Described below are methods for feeding or advancing guidewire 102 distally out of guidewire management device 600, 700, 900, 1200, 1300, or 1500. Further described below are methods for feeding or retracting guidewire 102 proximally into guidewire management device 600, 700, 900, 1200, 1300, or 1500.

[0052]

[0078] 9-12 to describe at least some of the unique features of guidewire management device 900 or 1200, guidewire management device 900 or 1200 has a first split sleeve 911 or 1211 formed within a distal portion of handle 940 or 1240.

[0053]

[0079] A first split sleeve 911 or 1211 separates from the first sleeve 910 or 1210 within the distal portion of the handle 940 or 1240. The first split sleeve 911 or 1211 is configured to have a lumen similar to the lumen of the first sleeve 110, 610, or 710 described above, and by extension, similar to the lumen of the first sleeve 910 or 1210. In effect, the lumen of the first split sleeve 911 or 1211 separates or branches from the lumen of the first sleeve 910 or 1210, thereby forming a branch lumen between the first sleeve 910 or 1210 and the first split sleeve 911 or 1211 within the distal portion of the handle 940 or 1240. The first sleeve 910 or 1210 is configured to at least route the guidewire 102 distally and out of the guidewire management device 900 or 1200, while the first split sleeve 911 or 1211 is configured to eject the splittable casing 904, which separates from the guidewire 102, while routing the guidewire 102 distally and out of the guidewire management device 900 or 1200. In effect, the branched lumens between the first sleeve 910 or 1210 and the first split sleeve 911 or 1211 are configured to facilitate the separation of the splittable casing 904 from the guidewire 102 while routing the guidewire 102 distally and out of the guidewire management device 900 or 1200.

[0054]

[0080] 12 to describe at least some of the unique features of guidewire management device 1200, guidewire management device 1200 has a flexible membrane 1206 that extends from a distal portion of guidewire management device 1200, over thumbwheel 1242, to a proximal portion of guidewire management device 1200. In practice, membrane 1206 may be coupled to a portion of a first sleeve 1210 in the distal portion of guidewire management device 1200 and a portion of a second sleeve 1220 in the proximal portion of guidewire management device 1200.

[0055]

[0081] Membrane 1206 is configured to route guidewire 102 distally out of guidewire management device 1200 or route guidewire 102 proximally into guidewire management device 1200. Membrane 1206 is sufficiently flexible to allow a middle portion of membrane 1206 to be pushed downward against a proximal portion of thumbwheel 1242 and move distally when thumbwheel 1242 is rotated, and to be released, in one or more additional steps described above, to return to the equilibrium state of membrane 1206. Similarly, membrane 1206 is sufficiently flexible to allow a middle portion of membrane 1206 to be pushed downward against a distal portion of thumbwheel 1242 and move proximally when thumbwheel 1242 is rotated, and to be released, in one or more additional steps described above, to return to the equilibrium state of membrane 1206.

[0056]

[0082] Membrane 1206 can have a low durometer, tackiness, or the like to facilitate gripping guidewire 102 or the combination of guidewires 102 within bag 104 or splittable casing 904 for the purpose of routing guidewire 102 distally out of guidewire management device 1200 or proximally into guidewire management device 1200. As shown in FIG. 12 , for example, the combination of guidewires 102 within splittable casing 904 is disposed between membrane 1206 and thumbwheel 1242 of guidewire management device 1200. When the middle portion of membrane 1206 is pressed downward against the proximal or distal portion of thumbwheel 1242, the combination of guidewires 102 within splittable casing 904 is also pressed downward against the proximal or distal portion of thumbwheel 1242. Then, when thumbwheel 1242 is rotated, the combination of guidewires 102 within splittable casing 904 is moved distally or proximally along with the intermediate portion of membrane 1206. Furthermore, when the intermediate portion of membrane 1206 is released, returning membrane 1206 to its equilibrium state, the combination of guidewires 102 within splittable casing 904 is also released. In this way, one or more of the above-described additional steps can advance guidewires 102 distally out of guidewire management device 1200 or advance guidewires 102 proximally into guidewire management device 1200.

[0057]

[0083] Referring to Figures 13 and 14 to describe at least some of the unique features of guidewire management device 1300, guidewire management device 1300 has a guidewire conduit 1350 coupled to second sleeve 1320 and a casing conduit 1354 coupled to both first split sleeve 1311 in the distal portion of handle 1340 and second split sleeve 1321 in the proximal portion of handle 1340.

[0058]

[0084] Although there may be possible differences in one or more design elements, the first split sleeve 1311 is similar to the first split sleeve 911 or 1211 described above. Accordingly, the descriptions provided above of the first split sleeves 911 and 1211 should be understood to extend to the first split sleeve 1311 as if the first split sleeve 1311 were included in the description of the first split sleeve 911 or 1211.

[0059]

[0085] A second split sleeve 1321 separates from the second sleeve 1320 within the distal portion of the handle 1340. The second split sleeve 1321 is configured to have a lumen similar to the lumen of the second sleeve 120, 620, or 720 described above, and by extension, similar to the lumen of the second sleeve 1320. In effect, the lumen of the second split sleeve 1321 separates or branches from the lumen of the second sleeve 1320, thereby forming a branch lumen between the second sleeve 1320 and the second split sleeve 1321 within the distal portion of the handle 1340. Similar to the channel 1341 of the handle 1340 configured to hold the guidewire conduit 1350 therein, the second split sleeve 1321 is configured to hold the casing conduit 1354 therein.

[0060]

[0086] As described above, thumbwheel 1342 is configured to assist in distally routing guidewire 102 through first sleeve 1310 and out of guidewire management device 1300. In cooperation with thumbwheel 1342, guidewire conduit 1350 is configured to distally route guidewire 102, or more specifically, guidewire 102 disposed within splittable casing 904, into second sleeve 1320. Guidewire conduit 1350 may be opaque or translucent, depending on the polymeric material selected. If guidewire conduit 1350 is translucent, guidewire conduit 1350 is configured to visualize guidewire 102 while routing guidewire 102 distally into second sleeve 1320. Additionally, casing conduit 1354 is configured to receive splittable casing 904 therein, which separates from guidewire 102 as it routes guidewire 102 distally and out of guidewire management device 1300. Similar to guidewire conduit 1350, casing conduit 1354 may be opaque or translucent, depending on the polymeric material selected. If casing conduit 1354 is translucent, casing conduit 1354 is configured to allow visualization of splittable casing 904 separating from guidewire 102 and into casing conduit 1354 as it routes guidewire 102 distally and out of guidewire management device 1300.

[0061]

[0087] As further described above, the thumbwheel 1342 is further configured to assist in routing the guidewire 102 proximally through the first sleeve 1310 and into the guidewire management device 1300. In cooperation with the thumbwheel 1342, the casing conduit 1354 is configured to route the splittable casing 904 into the first sleeve 1310, separating it from the guidewire 102 while routing the guidewire 102 distally and out of the guidewire management device 1300, and to route the guidewire 102 proximally for combination with the guidewire 102 as it enters the guidewire management device 1300. Again, the casing conduit 1354 can be opaque or translucent. If the casing conduit 1354 is translucent, the casing conduit 1354 is configured to visualize the splittable casing 904 while routing it proximally through the guidewire management device 1300 for combination with the guidewire 102. Guidewire conduit 1350 is configured to receive the combination of guidewire 102 and splittable casing 904 while advancing guidewire 102 proximally through guidewire management device 1300, and preferably, the guidewire 102 repositioned within splittable casing 940. Again, guidewire conduit 1350 may be opaque or translucent. If guidewire conduit 1350 is translucent, guidewire conduit 1350 is configured to allow visualization of the combination of guidewire 102 and splittable casing 904 while advancing guidewire 102 proximally through guidewire management device 1300.

[0062]

[0088] 15 and 16 to describe at least some of the unique features of guidewire management device 1500, guidewire management device 1500 has a guidewire-casing conduit 1550 coupled to both second sleeve 1520 and first split sleeve 1511 within a distal portion of handle 1540. Handle 1540 can have a channel 1541 configured to retain guidewire-casing conduit 1550 therein when guidewire-casing conduit 1550 is in a coiled configuration, such as the configuration shown.

[0063]

[0089] Although there may be possible differences in one or more design elements, the first split sleeve 1511 is similar to the first split sleeve 911 or 1211 described above. Accordingly, the descriptions provided above of the first split sleeves 911 and 1211 should be understood to extend to the first split sleeve 1511 as if the first split sleeve 1511 were included in the description of the first split sleeve 911 or 1211.

[0064]

[0090] As described above, the thumbwheel 1542 is configured to assist in distally routing the guidewire 102 through the first sleeve 1510 and out of the guidewire management device 1500. In cooperation with the thumbwheel 1542, the guidewire-casing conduit 1550 is configured to distally route the guidewire 102, or more specifically, the guidewire 102 disposed within the splittable casing 904, into the second sleeve 1520. The guidewire-casing conduit 1550 may be opaque or translucent, depending on the polymeric material selected. When the guidewire-casing conduit 1550 is translucent, the guidewire-casing conduit 1550 is configured to visualize the guidewire 102 while routing it distally into the second sleeve 1520. Additionally, guidewire-casing conduit 1550 is configured to receive splittable casing 904 therein, which separates from guidewire 102 as guidewire 102 is routed distally and out of guidewire management device 1500. The distal end of splittable casing 904, which separates from guidewire 102, is configured to track the bulbous end of guidewire 102 around guidewire-casing conduit 1550 as guidewire 102 is routed distally and out of guidewire management device 1500. In fact, if guidewire-casing conduit 1550 is translucent, guidewire-casing conduit 1550 is configured to visualize splittable casing 904 tracking the bulbous end of guidewire 102 around guidewire-casing conduit 1550 as guidewire 102 is routed distally and out of guidewire management device 1500.

[0065]

[0091] As further described above, the thumbwheel 1542 is further configured to assist in routing the guidewire 102 proximally through the first sleeve 1510 and into the guidewire management device 1500. In cooperation with the thumbwheel 1542, the guidewire-casing conduit 1550 is configured to route the splittable casing 904 into the first sleeve 1510 to separate from the guidewire 102 while routing the guidewire 102 distally and out of the guidewire management device 1500, so as to combine with the guidewire 102 as it is routed proximally into the guidewire management device 1500. Again, the guidewire-casing conduit 1550 may be opaque or translucent. If the guidewire-casing conduit 1550 is translucent, it is configured to allow visualization of the splittable casing 904 while advancing the splittable casing 904 proximally into the guidewire management device 1500 for combination with the guidewire 102. The guidewire-casing conduit 1550 is configured to receive the combination of the guidewire 102 and the splittable casing 904 therein while advancing the guidewire 102 proximally into the guidewire management device 1500, and preferably the guidewire 102 repositioned within the splittable casing 940. If the guidewire-casing conduit 1550 is translucent, it is configured to allow visualization of the combination of the guidewire 102 and the splittable casing 904 while advancing the guidewire 102 proximally into the guidewire management device 1500.

[0066]

[0092] 17 provides a side view of an assembly 1700 of guidewire management device 1500 coupled to a catheter assembly 1702, according to some embodiments. With the luer connectors of guidewire management device 1500 and catheter assembly 1720 coupled as shown, handle 1540 of guidewire management device 1500 allows for one-handed guidewire management while holding assembly 1700. method

[0093] The method of guidewire management device 100, 300, or 600 includes a connecting step of connecting the first sleeve 110 or 610 of guidewire management device 100, 300, or 600 to the hub of a medical device (e.g., a hollow needle) inserted into an insertion site of a patient.

[0067]

[0094] The method further includes an advancing step of advancing the guidewire 102 of the guidewire management device 100, 300, or 600 from the first sleeve 110 or 610, through the hub of the medical device, and into the insertion site of the patient. A seal (e.g., "O" ring 114 or 714) within the first sleeve 110 or 610 prevents fluid (e.g., air) from leaking from the guidewire management device 100, 300, or 600 as the guidewire 102 is advanced through the hub of the medical device and into the insertion site of the patient.

[0068]

[0095] The advancing step may include grasping the guidewire 102 within the sterile barrier 104 or 304 and manually advancing the guidewire 102 into the first sleeve 110. Such advancing may alternatively include pressing the guidewire 102 within the sterile barrier 104 against the thumbwheel 742 and rotating the thumbwheel 742 to advance the guidewire 102 into the first sleeve 610.

[0069]

[0096] In practice, guidewires 102 can be advanced into first sleeve 110 or 610 and out of guidewire management device 100 or 600 by picking up the combination of guidewires 102 within bag 104 or pressing guidewires 102 within bag 104 against thumbwheel 742, advancing guidewires 102 into first sleeve 110 manually or by turning thumbwheel 742, releasing the combination of guidewires 102 within bag 104, and repeating the above as needed. Guidewires 102 can be advanced into first sleeve 110 and out of guidewire management device 300 by picking up the combination of guidewires 102 within boot 304, manually advancing guidewires 102 into first sleeve 110, releasing the combination of guidewires 102 within boot 304, and repeating the above as needed.

[0070]

[0097] The method may further include a stopping step of stopping the advancement of guidewire 102 into the patient's insertion site when the bulbous end of guidewire 102 becomes trapped within narrowed portion 124 of bore 122 in second sleeve 120 of guidewire management device 100 or 300. Similarly, the stopping step may include stopping the advancement of guidewire 102 into the patient's insertion site when the bulbous end of guidewire 102 becomes trapped within recess 724 in second sleeve 620 of guidewire management device 600.

[0071]

[0098] The method further includes retracting the guidewire 102 from the insertion site in the patient, through the hub of the medical device, and into the first sleeve 110 or 610. A seal (e.g., "O" ring 114 or 714) within the first sleeve 110 or 610 prevents fluid (e.g., blood) from entering the guidewire management device 100, 300, or 600 as the guidewire 102 is retracted from the insertion site.

[0072]

[0099] In practice, guidewires 102 may be retracted into guidewire management device 100 or 600 through first sleeve 110 or 610 by picking up the combination of guidewires 102 within bag 104 or pressing guidewires 102 within bag 104 against thumbwheel 742, retracting guidewires 102 from first sleeve 110 manually or by turning thumbwheel 742, releasing the combination of guidewires 102 within bag 104, and repeating the above as needed. Guidewires 102 may be retracted into guidewire management device 300 through first sleeve 110 by picking up the combination of guidewires 102 within boot 304, manually retracting guidewires 102 from first sleeve 110, releasing the combination of guidewires 102 within boot 304, and repeating the above as needed.

[0073]

[0100] The method may further include stopping the retraction of the guidewire 102 from the patient's insertion site when the proximal or bulbous end of the guidewire 102 abuts a plug 152 within the proximal portion of the guidewire conduit 150 of the guidewire management device 100 or 300.

[0074]

[0101] Although some specific embodiments are disclosed herein, and specific embodiments are disclosed in some detail, these specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass these additional adaptations and / or modifications. Thus, variations may be made from the specific embodiments disclosed herein without departing from the scope of the concepts presented herein.

Claims

1. 1. A guidewire management device comprising: A guide wire; a first sleeve configured to route the guidewire distally out of the guidewire management device or route the guidewire proximally into the guidewire management device; a second sleeve proximal to the first sleeve configured to cooperate with the first sleeve to route the guidewire, wherein at least a portion of the length of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain sterility of the guidewire, the sterile barrier being a splittable casing configured to separate from the guidewire while routing the guidewire distally and out of the guidewire management device; a conduit coupled to the first sleeve, the conduit configured to receive a portion of the splittable casing separated from the guidewire.

2. 10. The guidewire management device of claim 1, wherein the first sleeve has a distal portion configured as a male connector with a luer taper for connecting the first sleeve to a complementary female connector.

3. The guidewire management device of claim 1 or 2, wherein the first sleeve is configured to straighten the guidewire when the guidewire is advanced proximally into the guidewire management device.

4. 4. The guidewire management device of claim 1, wherein the first sleeve comprises a seal configured to prevent fluid from entering or escaping from the guidewire management device when the guidewire is advanced proximally into the guidewire management device.

5. The guidewire management device of claim 1 , wherein the first sleeve has a proximal portion with a bore configured to accommodate a distal portion of the sterile barrier.

6. The guidewire management device of claim 1 , wherein the second sleeve has a distal portion having a bore configured to accommodate a proximal portion of the sterile barrier.

7. 7. The guidewire management device of claim 1, wherein the second sleeve has a proximal portion with another bore configured to prevent the end of the guidewire from passing completely through the second sleeve.

8. 8. The guidewire management device of claim 1, wherein the guidewire has a distal portion with a J-shaped tip, the J-shaped tip configured to straighten when the tip of the guidewire enters the first sleeve when the guidewire is advanced proximally into the guidewire management device.

9. 9. The guidewire management device of claim 1, wherein the guidewire has a proximal portion with a bulbous end configured to prevent the guidewire from passing completely through the second sleeve.

10. 10. The guidewire management device of claim 1, wherein the guidewire management device is configured to reposition the splittable casing over the guidewire while advancing the guidewire proximally into the guidewire management device.

11. 1. A guidewire management device comprising: The handle and A guide wire; a first sleeve formed within a distal portion of the handle; a second sleeve formed within a proximal portion of the handle, wherein at least a portion of the length of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain sterility of the guidewire, the sterile barrier being a splittable casing configured to separate from the guidewire while routing the guidewire distally and out of the guidewire management device; a thumbwheel disposed beneath the guidewire between the first and second sleeves configured to assist in distally routing the guidewire through the first sleeve and out of the guidewire management device or proximally routing the guidewire through the first sleeve and into the guidewire management device; a conduit coupled to the first sleeve, the conduit configured to receive a portion of the splittable casing separated from the guidewire; A guidewire management device comprising:

12. 12. The guidewire management device of claim 11, wherein the first sleeve has a distal portion configured as a male connector with a luer taper for connecting the first sleeve to a complementary female connector.

13. 13. The guidewire management device of claim 11 or 12, wherein the first sleeve is configured to straighten a J-shaped tip within a distal portion of the guidewire when the tip of the guidewire enters the first sleeve as the guidewire is advanced proximally into the guidewire management device.

14. 14. The guidewire management device of claim 11, wherein the second sleeve has a proximal portion having a bore with a narrowed portion configured to capture the bulbous end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

15. The guidewire management device of any one of claims 11 to 14, wherein the splittable casing overlies the entire guidewire except for the interior of the first sleeve or the distal side of the first sleeve.

16. a guidewire conduit coupled to the second sleeve configured to route the guidewire distally into the second sleeve; a casing conduit coupled to both a first split sleeve in the distal portion of the handle and a second split sleeve in the proximal portion of the handle, the casing conduit configured to receive the splittable casing therein, the split casing separating the guidewire while routing the guidewire distally and out of the guidewire management device; The guidewire management device of any one of claims 11 to 15, further comprising:

17. 17. The guidewire management device of claim 16, wherein the handle has a channel configured to retain the guidewire conduit therein when the guidewire conduit is in a coiled configuration.

18. 16. The guidewire management device of claim 11, further comprising a guidewire-casing conduit coupled to both the second sleeve and a first split sleeve within the distal portion of the handle, the guidewire-casing conduit configured to route the guidewire distally into the second sleeve and to receive the splittable casing therein via the first split sleeve, the splittable casing separating the guidewire from the guidewire while routing the guidewire distally out of the guidewire management device.

19. 20. The guidewire management device of claim 18, wherein a distal end of the splittable casing that separates from the guidewire is configured to track a proximal end of the guidewire around the guidewire-casing conduit while routing the guidewire distally and out of the guidewire management device.

20. 20. The guidewire management device of claim 18 or 19, wherein the handle has a channel configured to hold the guidewire-casing conduit therein when the guidewire-casing conduit is in a coiled configuration.

21. 21. The guidewire management device of claim 11, further comprising a flexible membrane extending from the distal portion of the handle over the thumbwheel to the proximal portion of the handle, the flexible membrane configured to be pressed downward against the thumbwheel to direct the guidewire distally out of the guidewire management device or to direct the guidewire proximally into the guidewire management device.

Images