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. Provisional Patent Application No. 62 / 989,397, 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, in some embodiments, is a method of a guidewire management device, the method including a connecting step of connecting a first sleeve of the guidewire management device to a hub of a medical device inserted into an insertion site of a patient. The first sleeve is configured as a male connector with a Luer taper. The method further includes an advancing step of advancing a guidewire of the guidewire management device from the first sleeve, through the hub of the medical device, and into the insertion site of the patient. The guidewire is disposed within a sterile barrier configured to maintain sterility of the guidewire before being advanced into the first sleeve. The method further includes a retracting step of retracting the guidewire from the insertion site of the patient, through the hub of the medical device, and into the first sleeve. A bore within a proximal portion of the first sleeve has a metering mechanism configured to adjust the sterile barrier extending out of the bore to retrieve the guidewire as the guidewire is retracted from the insertion site of the patient.

[0005]

[0006] In some embodiments, the advancing step includes grasping the guidewire within the sterile barrier and manually advancing the guidewire into the first sleeve, wherein the sterile barrier is a pleated bag or a bellows boot.

[0006]

[0007] In some embodiments, the advancing step includes pressing the guidewire within the sterile barrier against a thumbwheel and rotating the thumbwheel to advance the guidewire into the first sleeve, wherein the sterile barrier is a pleated bag.

[0007]

[0008] In some embodiments, the method further includes a stopping step of stopping advancement of the guidewire into the patient's insertion site when the bulbous end of the proximal portion of the guidewire becomes trapped within a constriction of the bore in the proximal portion of the second sleeve of the guidewire management device.

[0008]

[0009] In some embodiments, a seal within the first sleeve prevents fluid from entering or escaping from the guidewire management device when the guidewire is retracted from the patient's insertion site, through the hub of the medical device, and into the first sleeve.

[0009]

[0010] In some embodiments, the distal portion of the guidewire has a J-shaped tip that is configured to straighten when the tip of the guidewire enters the first sleeve upon retraction of the guidewire from the insertion site.

[0010]

[0011] In some embodiments, the method further includes stopping retraction of the guidewire from the patient's insertion site when the proximal end of the guidewire abuts a plug within the proximal portion of the guidewire conduit of the guidewire management device.

[0011]

[0012] 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, a wheel disposed under the guidewire between the first and second sleeves, the wheel configured to grip the guidewire when the wheel is rotated, and a knob coupled to the wheel. The guidewire extends between the first and second sleeves while being disposed within a capsule for maintaining sterility of the guidewire. The knob is configured to assist in routing the guidewire distally through the first sleeve and out of the guidewire management device when the knob is rotated clockwise. The knob is further configured to assist in routing the guidewire proximally through the first sleeve and into the guidewire management device when the knob is rotated counterclockwise.

[0012]

[0013] 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]

[0014] In some embodiments, the first sleeve is configured to straighten the J-shaped tip of 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]

[0015] 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]

[0016] In some embodiments, the guidewire management device further includes a guidewire conduit coupled to the second sleeve, the guidewire conduit configured to route the guidewire distally through the second sleeve and into the guidewire management device, the guidewire conduit configured to maintain sterility of the guidewire outside of the first sleeve, the capsule, and the second sleeve.

[0016]

[0017] In some embodiments, the handle has a channel configured to hold the guidewire conduit therein when the guidewire conduit is in a coiled configuration.

[0018] 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 gapped guidewire conduit coupled to the second sleeve. At least a portion of the length of the guidewire extends between the first and second sleeves while disposed within a sterile barrier configured to maintain sterility of the guidewire. The gap in the gapped guidewire conduit is configured to grip the guidewire and allow it to be routed distally through the second sleeve and into the guidewire management device.

[0017]

[0019] 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.

[0018]

[0020] In some embodiments, the first sleeve is configured to straighten the J-shaped tip of 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.

[0019]

[0021] 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.

[0020]

[0022] In some embodiments, the sterility barrier is a pleated bag over the entire guidewire except for within or distal to the first sleeve, the bag being configured to pleat as the bag is inserted into a bore in the proximal portion of the first sleeve while advancing the guidewire distally and out of the guidewire management device.

[0021]

[0023] In some embodiments, the sterility barrier is a splittable casing over the entire guidewire except within or distal to the first sleeve, the splittable casing configured to separate from the guidewire while routing the guidewire distally and out of the guidewire management device.

[0022]

[0024] In some embodiments, the guidewire management device further includes a first split sleeve within the distal portion of the handle configured to eject the splittable casing while advancing the guidewire distally and out of the guidewire management device.

[0023]

[0025] 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, a guidewire conduit coupled to the second sleeve, and a tether coupled to a proximal portion of the guidewire and disposed within the guidewire conduit along with the guidewire. The guidewire extends between the first and second sleeves, optionally disposed within a capsule for maintaining sterility of the guidewire. The guidewire conduit is configured to route the guidewire distally through the second sleeve and into the guidewire management device. The guidewire conduit is configured to maintain sterility of the guidewire outside the first sleeve, capsule, and second sleeve. The tether is configured to assist in routing the guidewire distally through the first sleeve and out of the guidewire management device when the tether is withdrawn from the guidewire management device.

[0024]

[0026] 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.

[0025]

[0027] In some embodiments, the first sleeve is configured to straighten the J-shaped tip of 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.

[0026]

[0028] In some embodiments, the second sleeve has a proximal portion having a bore with a narrowed portion configured to capture a mass around the proximal portion of the guidewire and prevent the guidewire from passing completely through the second sleeve.

[0027]

[0029] In some embodiments, the handle has a guidewire conduit channel configured to hold the guidewire conduit therein when the guidewire conduit is in a coiled configuration.

[0028]

[0030] In some embodiments, the handle has a tether channel extending through a portion of the handle, and the tether is disposed within the tether channel without a guidewire.

[0031] In some embodiments, the tether wire is sufficiently stiff to allow it to be routed proximally into the guidewire management device along with the guidewire.

[0029]

[0032] In some embodiments, the guidewire management device further comprises a thumbwheel configured to assist in routing the tether wire distally out of the guidewire management device.

[0030]

[0033] In some embodiments, the tether wire is coupled to a slider disposed within a slot in the handle, the slider configured to provide at least a user interface for distally routing the guidewire out of the guidewire management device.

[0031]

[0034] In some embodiments, the guidewire management device is configured so that the tether wire does not contact the guidewire except for a coupler that joins the proximal ends of the tether wire and guidewire together.

[0032]

[0035] In some embodiments, the guidewire is disposed within a splittable casing that is within at least the guidewire conduit, and any portion of the splittable casing that separates from the guidewire forms at least a tether line configured to provide a user interface for distally routing the guidewire out of the guidewire management device.

[0033]

[0036] 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, a guidewire conduit coupled to the second sleeve, and a combination of a thumbwheel, a guidewire gripping wheel coupled to the thumbwheel, and a compression wheel located between the first and second sleeves. The guidewire is concealed within the handle between the first and second sleeves to maintain sterility of the guidewire. The guidewire conduit is configured to route the guidewire distally through the second sleeve and into the guidewire management device, and to maintain sterility of the guidewire in combination with the handle. The guidewire is disposed between the guidewire gripping wheel and the compression wheel, such that, as the thumbwheel rotates, the guidewire is routed distally through the first sleeve and out of the guidewire management device or proximally through the first sleeve and into the guidewire management device.

[0034]

[0037] 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, U.S. Patent Application No. 17 / 079,320, filed October 23, 2020, is incorporated herein by reference in its entirety. [Brief explanation of the drawings]

[0035] [Figure 1]

[0038] FIG. 1 is an isometric view illustrating a first guidewire management device according to some embodiments. [Figure 2]

[0039] 1A-1C are longitudinal cross-sectional views illustrating a first guidewire management device according to some embodiments. [Figure 3]

[0040] FIG. 10 is an isometric view of a second guidewire management device according to some embodiments. [Figure 4]

[0041] 10A-10C are longitudinal cross-sectional views illustrating a second guidewire management device according to some embodiments. [Figure 5]

[0042] 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]

[0043] FIG. 10 is a side view illustrating a third guidewire management device according to some embodiments. [Figure 7]

[0044] FIG. 10 is an isometric view of a handle of a fourth guidewire management device according to some embodiments. [Figure 8]

[0045] 10A-10C are longitudinal cross-sectional views illustrating a fourth guidewire management device according to some embodiments. [Figure 9]

[0046] FIG. 10 is a side view illustrating a fifth guidewire management device according to some embodiments. [Figure 10]

[0047] 10A-10C are longitudinal cross-sectional views illustrating a fifth guidewire management device according to some embodiments. [Figure 11]

[0048] FIG. 10 is a top view of a sixth guidewire management device according to some embodiments. [Figure 12]

[0049] FIG. 10 is a side view illustrating a seventh guidewire management device according to some embodiments. [Figure 13]

[0050] FIG. 10 is a side view illustrating an eighth guidewire management device according to some embodiments. [Figure 14]

[0051] FIG. 13 is a side view illustrating a ninth guidewire management device according to some embodiments. [Figure 15]

[0052] FIG. 14 is a side view illustrating a tenth guidewire management device according to some embodiments. [Figure 16]

[0053] FIG. 16 is a side view illustrating an eleventh guidewire management device according to some embodiments. [Figure 17]

[0054] FIG. 16 is a top view showing the handle of an eleventh guidewire management device according to some embodiments. [Figure 18]

[0055] FIG. 16 is a side view illustrating a twelfth guidewire management device according to some embodiments. [Figure 19]

[0056] FIG. 16 is a longitudinal cross-sectional view of a twelfth guidewire management device according to some embodiments. [Figure 20]

[0057] FIG. 16 is a top view showing the handle of a twelfth guidewire management device according to some embodiments. [Figure 21]

[0058] A detailed view showing the proximal portion of the handle of a twelfth guidewire management device according to some embodiments. [Figure 22]

[0059] FIG. 16 is a detailed view showing a proximal portion of the handle of a twelfth guidewire management device without a guidewire conduit, according to some embodiments. [Figure 23]

[0060] FIG. 16 is a detailed view showing a proximal portion of a guidewire conduit of a twelfth guidewire management device according to some embodiments. [Figure 24]

[0061] FIG. 13 is an isometric view of a thirteenth guidewire management device according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0036]

[0062] 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.

[0037]

[0063] 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 serial limitation or numerical limit. 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, orientation, or direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0038]

[0064] 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.

[0039]

[0065] 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.

[0040]

[0066] With respect to "tether," a tether as disclosed herein includes a tether mechanism including any tether line, tether handle, slider, or other element directly or indirectly coupled to a guidewire configured to advance or retract the guidewire out of or into a guidewire management device, respectively.

[0041]

[0067] 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.

[0068] 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

[0069] 1-23 illustrate various guidewire management devices, namely, guidewire management devices 100, 300, 600, 700, 1700, 2000, 2100, 2200, 2300, 2400, and 2600. 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 among any group of guidewire management devices may be similarly described for various guidewire management devices 100, 300, 600, 700, 1700, 2000, 2100, 2200, 2300, 2400, and 2600. Following an initial description of guidewire management devices 100, 300, 600, and 700, guidewire management devices 100, 300, 600, 700, 1700, 2000, 2100, 2200, 2300, 2400, and 2600 will be described below, individually or collectively, with reference to some of their unique features.

[0042]

[0070] 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.

[0043]

[0071] 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 of, for example, the above-described catheter, the 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., advancing the guidewire 102 distally out of the guidewire management device 100, 300, 600, or 700 and into the catheter).

[0044]

[0072] First sleeve 110, 610, or 710 has a proximal portion with a bore (i.e., hole) 112, 612 (not shown), or 712 to which the lumen of first sleeve 110, 610, or 710 opens. Bore 112, 612, or 712 is configured to receive or collect a distal portion of sterile barrier 104 or 304 as guidewire 102 is advanced distally out of guidewire management device 100, 300, 600, or 700. Bore 112, 612, or 712 can have an adjustment feature, such as a circumferential ridge of bore 112, 612, or 712. Such circumferential ridges are configured to retain a rear portion (e.g., pleats) of sterile barrier 104 within bore 112, 612, or 712 distal to the circumferential ridges after a distal portion of sterile barrier 104 is received within bore 112, 612, or 712. When guidewire 102 is advanced proximally into guidewire management device 100, 300, or 700, as described below, sterile barrier 104 is adjusted to exit bore 112, 612, or 712 in small increments (e.g., one pleat at a time), thereby facilitating proximal advancement of guidewire 102 into guidewire management device 100, 300, or 700 by advancing only the amount of sterile barrier 104 immediately needed to retrieve guidewire 102.

[0045]

[0073] 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. First sleeve 110, 610, or 710 can have a guidewire lock configured to lock guidewire 102 in place, for example, when guidewire 102 is advanced proximally into guidewire management device 100, 300, 600, or 700 to reach a desired depth of guidewire 102 within the patient. The guidewire lock can be configured to lock guidewire 102 in place by rotating the distal end piece of first sleeve 110, 610, or 710 to more tightly compress "O" ring 114 against guidewire 102.Alternatively, the guidewire lock can have a ball stopper configured to move along the guidewire management device 100, 300, 600, or 700 and tighten, thereby allowing the clinician to adjust the guidewire lock to prevent the guidewire 102 from being deployed beyond the midpoint when the clinician only deploys the guidewire 102 to the midpoint.

[0046]

[0074] 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.

[0047]

[0075] 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 stop means for stopping the end of the guidewire 102 to prevent a mass, such as a bulbous or slug end of the guidewire 102, from passing completely through the second sleeve 120, 620, or 720 as the guidewire 102 is advanced distally and out of the guidewire management device 100, 300, 600, or 700. Because narrowed portion 124, recess 724, or similar stop means is configured to stop the end of guidewire 102 from passing completely through second sleeve 120, 620, or 720, narrowed portion 124, recess 724, or similar stop means is also configured to stop the guidewire from passing completely through guidewire management device 100, 300, 600, or 700 and into the patient (where guidewire 102 may be lost). Nevertheless, the mass may be configured to sever the end of guidewire 102 upon manual application of a threshold tension, such as after guidewire 102 has reached its appropriate depth within the patient, when it is desired to release the guidewire from guidewire management device 100, 300, 600, or 700.

[0048]

[0076] 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.

[0049]

[0077] Guidewire 102 has a distal portion and a proximal portion.

[0078] 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 extends beyond the needle, such as in a blood vessel.

[0050]

[0079] The proximal portion of the guidewire 102 can have a mass, such as a bulbous end of the guidewire 102, 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.

[0051]

[0080] 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.

[0052]

[0081] 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 when passed 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 advancing guidewire 102 proximally into guidewire management device 100, 600, or 700. Bag 104 is further configured to pleat when inserted into or through second sleeve 120, 620, or 720 of guidewire management device 100 while advancing guidewire 102 proximally into guidewire management device 100, 600, or 700.

[0053]

[0082] Advantageously, in guidewire management devices such as guidewire management devices 600 and 700, the combination of a portion of the length of bag 104, the sealed (e.g., heat-shrunk) proximal end of bag 104, and the attached distal end of bag 104 is configured to provide a stop for the end (e.g., bulbous end) of guidewire 102 as it is routed proximally into guidewire management device 600 or 700. That is, the proximal end of bag 104 itself provides a stop as guidewire 102 is routed proximally into guidewire management device 600 or 700 until bag 104 reaches its maximum length from where it is attached to guidewire management device 600 or 700. By blocking the end of guidewire 102 so that it does not pass through the proximal end of bag 104, the tip of guidewire 102 is prevented from passing completely through first sleeve 110 and reforming its J-shaped tip when guidewire 102 is advanced proximally into guidewire management device 600 or 700.

[0054]

[0083] 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.

[0055]

[0084] 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.

[0056]

[0085] 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.

[0057]

[0086] 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 1204 (see FIG. 12 ) that overlies the entire guidewire 102 or over at least a majority of the guidewire 102, except within or distal to first sleeve 110, 610, or 710. Splittable casing 1204 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 1700, 2000, 2100, 2200, 2300, and 2400.) Some of the above-described guidewire management devices are configured to insert guidewire 102 into splittable casing 1204 while routing guidewire 102 proximally and into the guidewire management device. Dividable casing 1204 can have scale markings thereon configured to indicate the length of a portion of guidewire 102 from the distal end of guidewire 102 .

[0058]

[0087] 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.

[0059]

[0088] 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.

[0060]

[0089] FIG. 5 shows the bulbous end of guidewire 102 distal to plug 152 within guidewire conduit 150, according to some embodiments.

[0090] Guidewire conduit 150 has a proximal portion with a plug 152 configured to stop the bulbous end of guidewire 102 (or any similar mass at the 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. By stopping the bulbous end of guidewire 102 from passing through such an opening in guidewire conduit 150, the tip of guidewire 102 is prevented 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.

[0061]

[0091] Referring to Figures 6-8 to describe at least some of the unique features of guidewire management devices 600 and 700, guidewire management device 600 or 700 includes a handle 640 or 740, a guidewire 102, a first sleeve 610 or 710 formed within a distal portion of handle 640 or 740, a second sleeve 620 or 720 formed within a proximal portion of handle 640 or 740, and a thumbwheel 642 or 742 disposed under guidewire 102 between first sleeve 610 or 710 and second sleeve 620 or 720.

[0062]

[0092] Handle 640 or 740 is ambidextrous, as it is configured to be held in either the clinician's right or left hand. Additionally, handle 640 or 740 is configured to be held in at least two configurations. A first configuration, when handle 640 or 740 is held by a clinician in a manner such as a person might hold the handle of a hammer, is a general configuration for handling guidewire management device 600 or 700. A second configuration, when the clinician repositions their thumb over thumbwheel 642 or 742, is an operable configuration for advancing guidewire 102 out of or retracting guidewire 102 into guidewire management device 600 or 700. Notwithstanding the above, some clinicians may find it comfortable to hold handle 640 or 740 in a manner such as a person might hold the barrel of a flashlight, thereby allowing access to both the first and second configurations with reduced hand movement.

[0063]

[0093] Handle 640 has a channel 641 configured to hold a conduit therein. The conduit may be a guidewire conduit, a guidewire-casing conduit, or the like. Advantageously, this channel can hold the conduit in a coiled configuration, thereby allowing an otherwise elongated conduit to be packed into a compact space. While only handle 640 with an optional channel is shown, handle 740 can have a channel configured to hold a conduit. In addition, handle 640 need not have channel 641.

[0064]

[0094] The thumbwheel 642 or 742 may be rotatably mounted on an axle fixedly coupled to each side of the handle 640 or 740, such that the thumbwheel 642 or 742 rotates relative to both the axle and the handle 640 or 740. Alternatively, the thumbwheel 642 or 742 may have an axle (e.g., as a single piece) or may be fixedly mounted on an axle, which in turn is rotatably coupled to each side of the handle 640 or 740, such that the combination of the thumbwheel 642 or 742 and axle rotates relative to the handle 640 or 740. The thumbwheel 642 or 742 is configured to assist in routing the guidewire 102 distally through the first sleeve 610 or 710 and out of the guidewire management device 600 or 700. Thumbwheel 642 or 742 is further configured to assist in routing guidewire 102 proximally through first sleeve 610 or 710 and into guidewire management device 600 or 700 .

[0065]

[0095] Below, methods are described for delivering or advancing guidewire 102 distally and out of guidewire management device 600 or 700. Further below, methods are described for delivering or retracting guidewire 102 proximally and into guidewire management device 600 or 700.

[0066]

[0096] 9-11 to describe at least some of the unique features of guidewire management device 1700, guidewire management device 1700 includes a handle 1740, a guidewire 102, a first sleeve 1710 formed within a distal portion of handle 1740, a second sleeve 1720 formed within a proximal portion of handle 1740, a guidewire gripping wheel 1742 disposed below guidewire 102 between first sleeve 1710 and second sleeve 1720 configured to grip the guidewire when guidewire gripping wheel 1742 is turned, and a knob 1744 coupled to guidewire gripping wheel 1742. Guidewire 102 extends between first sleeve 1710 and second sleeve 1720 and is disposed within capsule 1746, which acts as a sterility barrier to maintain the sterility of guidewire 102 between first sleeve 1710 and second sleeve 1720. In addition to capsule 1746, guidewire management device 1700 has a guidewire conduit 1750 coupled to second sleeve 1720 configured to maintain the sterility of guidewire 102 outside of first sleeve 1710, capsule 1746, and second sleeve 1720. Because both capsule 1746 and guidewire conduit 1750 are configured to maintain the sterility of the guidewire, a sterility barrier such as bag 104 or splittable casing 1204 is not required for guidewire management device 1700.

[0067]

[0097] Although there may be differences in one or more design elements, handle 1740 is similar to handle 640 described above. Accordingly, the description provided above of handle 640 should be understood to extend to handle 1740 as if handle 1740 were included in the description of handle 640. This also includes the description for channel 641 because handle 1740 also has channel 1741.

[0068]

[0098] Although there may be possible differences in one or more design elements, the first sleeve 1710 is 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 sleeve 1710 as if the first sleeve 1710 were included in the descriptions of the first sleeves 110, 610, and 710.

[0069]

[0099] Although there may be possible differences in one or more design elements, second sleeve 1720 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeve 120, 620, and 720 should be understood to extend to second sleeve 1720 as if second sleeve 1720 were included in the descriptions of second sleeve 120, 620, and 720.

[0070]

[0100] The combination of guidewire gripping wheel 1742 and knob 1744 is configured to route guidewire 102 distally out of guidewire management device 1700 or route guidewire 102 proximally into guidewire management device 1700. In practice, guidewire gripping wheel 1742 has an axle (e.g., as a single piece) fixedly coupled to knob 1744, such that when knob 1744 is rotated relative to handle 1740, guidewire gripping wheel 1742 rotates with knob 1744. Alternatively, knob 1744 has an axle (e.g., as a single piece) and guidewire gripping wheel 1742 is fixedly coupled to the axle of knob 1744, such that when knob 1744 is rotated relative to handle 1740, guidewire gripping wheel 1742 rotates with knob 1744. Further alternatively, guidewire gripping wheel 1742 and knob 1744 can be independently fixedly coupled to a shaft such that when knob 1744 is rotated relative to handle 1740, guidewire gripping wheel 1742 rotates with knob 1744. In this manner, the guidewire gripping wheel 1742 and knob 1744 combination is configured to assist in distally routing guidewire 102 through first sleeve 1710 and out of guidewire management device 1700, such as when knob 1744 is rotated clockwise. The guidewire gripping wheel 1742 and knob 1744 combination can be configured to slide when a threshold pressure is encountered while distally routing guidewire 102 out of guidewire management device 1700. The combination of guidewire gripping wheel 1742 and knob 1744 is further configured to assist in advancing guidewire 102 proximally through first sleeve 1710 and into guidewire management device 1700, such as when knob 1744 is rotated counterclockwise.The guidewire gripping wheel 1742 has teeth configured to grip the guidewire 102 using friction created by gently pressing the guidewire 102 against the capsule 1746 to either advance the guidewire 102 distally out of the guidewire management device 1700 or advance the guidewire 102 proximally into the guidewire management device 1700.

[0071]

[0101] A capsule 1746 extends over the guidewire 102 between the first sleeve 1710 and the second sleeve 1720, thereby maintaining the sterility of the guidewire 102 between the first sleeve 1710 and the second sleeve 1720. The capsule 1746 provides a backing against which the guidewire gripping wheel 1742 is configured to gently press the guidewire 102 for distally routing the guidewire 102 out of the guidewire management device 1700 or for gripping the guidewire 102 for proximally routing the guidewire 102 into the guidewire management device 1700. The capsule 1746 may be translucent to allow visualization of the guidewire 102 during distal routing out of or proximally routing the guidewire 102 into the guidewire management device 1700. However, the capsule 1746 may also be opaque. This is because, if the guidewire conduit 1750 is translucent as described later, it is possible to visualize the guidewire 102 within the guidewire conduit 1750 while advancing the guidewire 102 distally and out of the guidewire management device 1700 or while advancing the guidewire 102 proximally and into the guidewire management device 1700.

[0072]

[0102] Guidewire conduit 1750 is configured to route guidewire 102 distally through second sleeve 1720 and into guidewire management device 1700 during distal routing of guidewire 102 out of guidewire management device 1700, and to receive guidewire 102 proximally through second sleeve 1720 and back within guidewire conduit 1750 during proximal routing of guidewire 102 into guidewire management device 1700. Guidewire conduit 1750 can be opaque or translucent, depending on the polymeric material selected. If the guidewire conduit 1750 is translucent, the guidewire conduit 1750 is configured to allow visualization of the guidewire 102 while it is being advanced distally into the guidewire management device 1700, or while it is being advanced proximally into the guidewire management device 1700 and the guidewire 102 is again received within the guidewire conduit 1750.

[0073]

[0103] Guidewire management device 1700 can further include one or more guidewire conduit clips 1758 configured to hold various portions of guidewire conduit 1750 therein. Advantageously, guidewire conduit clips 1758 can hold guidewire conduit 1750 in a coiled configuration, thereby allowing an otherwise elongated guidewire conduit 1750 to be packed into a compact space.

[0074]

[0104] Referring to Figures 12 and 13 to describe at least some of the unique features of guidewire management device 2000 or 2100, guidewire management device 2000 or 2100 includes a handle 2040 or 2140, a guidewire 102, a first sleeve 2010 or 2110 formed within a distal portion of handle 2040 or 2140, a second sleeve 2020 or 2120 formed within a proximal portion of handle 2040 or 2140, and a guidewire conduit 2050 or 2150 having a gap (i.e., an interruption) coupled to second sleeve 2020 or 2120.

[0075]

[0105] Handle 2040 or 2140 is similar to handle 640 described above, although there are some differences in one or more design elements, such as not having a thumbwheel (e.g., thumbwheel 642). Accordingly, the description above of handle 640 should be understood to extend to handle 2040 or 2140 as if handle 2040 or 2140 were included in the description of handle 640. This also includes the description for channel 641 because handle 2040 or 2140 also has a channel (not shown). However, as suggested, handle 2040 or 2140 does not have a thumbwheel, such as thumbwheel 642 of handle 640, and therefore the description above does not extend to handle 2040 or 2140. Instead, the handle 2040 or 2140 has a ridge 2042 or 2142 that is between the first sleeve 2010 or 2110 and the second sleeve 2020 or 2120. The ridge 2042 or 2142 may be arcuate, as shown, or striped (e.g., having transverse grooves), and is configured to provide a tactile sense of placement when the clinician chooses to gently press the guidewire 102 into the ridge 2042 or 2142 with their thumb or using available pressure to either advance the guidewire 102 distally out of the guidewire management device 2000 or 2100 or advance the guidewire 102 proximally into the guidewire management device 2000 or 2100.

[0076]

[0106] Although there may be possible differences in one or more design elements, the first sleeve 2010 or 2110 is similar to the first sleeve 110, 610, or 710 described above. Accordingly, the above description of the first sleeve 110, 610, or 710 should be understood to extend to the first sleeves 2010 and 2110 as if they were included in the description of the first sleeves 110, 610, and 710.

[0077]

[0107] Although there may be possible differences in one or more design elements, second sleeve 2020 or 2120 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the above description of second sleeve 120, 620, or 720 should be understood to extend to second sleeve 2020 or 2120 as if second sleeve 2020 and 2120 were included in the description of second sleeve 120, 620, and 720.

[0078]

[0108] The gapped guidewire conduit 2050 or 2150 has a gap 2056 or 2156 within the gapped guidewire conduit 2050 or 2150 proximal to the second sleeve 2020 or 2120. The gap 2056 or 2156 is configured to expose the guidewire 102 within the gapped guidewire conduit 2050 or 2150 such that the guidewire 102 can be grasped (e.g., between the thumb and index finger) and routed distally through the second sleeve 2020 or 2120 into the guidewire management device 2000 or 2100. As guidewire 102 is routed distally through second sleeve 2020 or 2120 and into guidewire management device 2000 or 2100, guidewire 102 is further routed distally through first sleeve 2010 or 2110 and out of guidewire management device 2000 or 2100. Gap 2056 or 2156 is further configured to expose guidewire 102 within gapped guidewire conduit 2050 or 2150 such that guidewire 102 can be grasped (e.g., between the thumb and index finger) and routed proximally through second sleeve 2020 or 2120 and into gapped guidewire conduit 2050 or 2150. As guidewire 102 is routed proximally through second sleeve 2020 or 2120 and into gapped guidewire conduit 2050 or 2150, guidewire 102 is further routed proximally through first sleeve 2010 or 2110 and into guidewire management device 2000 or 2100. Routed proximally or distally with guidewire 102 exposed by gap 2056 or 2156 may be useful for larger or smaller routed lengths for coarse or fine adjustment of guidewire 102, whereas a clinician may find routed proximally or distally with guidewire 102 over ridge 2042 or 2142 as described above more suitable for smaller routed lengths for fine adjustment of guidewire 102.

[0079]

[0109] Guidewire management device 2000 or 2100 may further include one or more guidewire conduit clips, such as guidewire conduit clip 2058, configured to hold therein various portions of gapped guidewire conduit 2050. The guidewire conduit clips advantageously hold gapped guidewire conduit 2050 or 2150 in a coiled configuration as described above in connection with guidewire management device 1700, but also advantageously provide structural integrity to gapped guidewire conduit 2050 or 2150 when positioned on either side of gap 2056 or 2156.

[0080]

[0110] Because the configuration of guidewire management device 2000 or 2100 requires direct handling of guidewire 102, the entire guidewire 102 is disposed within a sterile barrier, such as bag 104 or divisible casing 1204, except for any portion of guidewire 102 within or distal to first sleeve 2010 or 2110. When the sterile barrier is bag 104, first sleeve 2010 or 2110 has a bore, such as bore 112, 612, or 712 of guidewire management device 100, 600, or 700, within the proximal portion of first sleeve 2010 or 2110, such that bag 104 can pleat as it is inserted into first sleeve 2010 while feeding guidewire 102 distally and out of guidewire management device 2000 or 2100. When the sterility barrier is a splittable casing 1204, the splittable casing 1204 is configured to separate from the guidewire 102 while routing the guidewire distally and out of the guidewire management device 2000 or 2100.

[0081]

[0111] Guidewire management device 2000 or 2100 may be configured with or without a first split sleeve for ejecting splittable casing 1204, which separates from guidewire 102 as guidewire 102 is advanced distally and out of guidewire management device 2000 or 2100. For example, guidewire management device 2000 is shown without such a first split sleeve. In such an embodiment, splittable casing 1204, which separates from guidewire 102 as guidewire 102 is advanced distally and out of guidewire management device 2000, separates from guidewire 102 between first sleeve 2010 and second sleeve 2020 and is ejected on one side of handle 2040. Guidewire management device 2100, however, is shown with first split sleeve 2111. In such an embodiment, the first split sleeve 2111 is configured to eject the splittable casing 1204 while advancing the guidewire 102 distally and out of the guidewire management device 2100. Whether or not the guidewire management device 2000 or 2100 has a split sleeve, a clinician may find it useful to advance the guidewire 102 distally by pulling the splittable casing 1204 like a tether, which separates the guidewire 102. Indeed, in cases where the guidewire 102 is advanced distally a large distance to coarsely adjust the guidewire 102, a clinician may find it more appropriate to advance the guidewire 102 distally in this manner.

[0082]

[0112] 14 and 15 to describe at least some of the unique features of guidewire management device 2200 or 2300, guidewire management device 2200 or 2300 includes a handle 2240 or 2340, a guidewire 102, a first sleeve 2210 or 2310 formed within a distal portion of handle 2240 or 2340, a second sleeve 2220 or 2320 formed within a proximal portion of handle 2240 or 2340, a guidewire conduit 2250 or 2350 coupled to second sleeve 2220 or 2320, and a tether, such as tether 2360 coupled to a proximal portion of guidewire 102 and disposed within guidewire conduit 2250 or 2350 along with the guidewire.

[0083]

[0113] Handle 2240 or 2340 is similar to handle 640 described above, although there may be differences in one or more design elements, such as tether channel 2361 extending through at least a portion of handle 2340, which carries the tether line of guidewire management device 2300. Accordingly, the description provided above of handle 640 should be understood to extend to handle 2240 or 2340 as if handle 2240 or 2340 were included in the description of handle 640. This also includes the description for channel 641, since handle 2240 or 2340 also has a channel (not shown).

[0084]

[0114] Although there may be possible differences in one or more design elements, first sleeve 2210 or 2310 is similar to first sleeve 110, 610, or 710 described above. Accordingly, the descriptions provided above for first sleeve 110, 610, and 710 should be understood to extend to first sleeve 2210 or 2310 as if first sleeve 2210 or 2310 were included in the descriptions of first sleeve 110, 610, and 710.

[0085]

[0115] Although there may be possible differences in one or more design elements, second sleeve 2220 or 2320 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeve 120, 620, and 720 should be understood to extend to second sleeve 2220 or 2320 as if second sleeve 2220 or 2320 were included in the descriptions of second sleeve 120, 620, and 720.

[0086]

[0116] Guidewire management device 2200 or 2300 can have membrane 2206 (not shown) or 2306 or capsule 2246 (not shown) or 2346 extending over guidewire 102 between first sleeve 2210 or 2310 and second sleeve 2220 or 2320, thereby maintaining sterility of guidewire 102 between first sleeve 2210 or 2310 and second sleeve 2220 or 2320. If guidewire management device 2200 or 2300 has membrane 2206 or 2306, guidewire management device 2200 or 2300 can further have a thumbwheel, such as thumbwheel 1242 described above in connection with guidewire management device 1200, or a ridge, such as ridge 2042 or 2142 described above in connection with guidewire management device 2000 or 2100. The thumbwheel may be configured to at least route guidewire 102 proximally into guidewire management device 2200 or 2300, while the tether is configured to route guidewire 102 distally and out of guidewire management device 2200 or 2300, as described below. Similarly, the ridge may be configured to at least route guidewire 102 proximally into guidewire management device 2200 or 2300, as described above in connection with at least guidewire management device 2000 or 2100. If guidewire management device 2200 or 2300 includes capsule 2246 or 2346, guidewire management device 2200 or 2300 may further include a knob coupled to the guidewire gripping wheel. The knob and guidewire gripping wheel may be configured to at least route the guidewire 102 proximally into the guidewire management device 2200 or 2300, while the tether is configured to route the guidewire distally and out of the guidewire management device 2200 or 2300, as described below.

[0087]

[0117] Guidewire conduit 2250 or 2350 is configured to maintain the sterility of guidewire 102 outside first sleeve 2210 or 2310, membrane 2206 (not shown) or 2306 or capsule 2246 (not shown) or 2346, and second sleeve 2220 or 2320. Guidewire conduit 2250 or 2350 is configured to route guidewire 102 distally through second sleeve 2220 or 2320 and into guidewire management device 2200 or 2300 during distal routing of guidewire 102 out of guidewire management device 2200 or 2300, and to receive guidewire 102 proximally through second sleeve 2220 or 2320 within guidewire conduit 2250 or 2350 during proximal routing of guidewire 102 into guidewire management device 1200 or 2300. Guidewire conduit 2250 or 2350 may be opaque or translucent, depending on the polymeric material selected. If guidewire conduit 2250 or 2350 is translucent, it is configured to allow visualization of guidewire 102 while it is being routed distally into guidewire management device 2200 or 2300, or while it is being received again within guidewire conduit 2250 or 2350 as it is being routed proximally into guidewire management device 2200 or 2300. As shown in FIG. 14 , guidewire conduit 2250 of guidewire management device 2300 can have an opening proximal to second sleeve 2220 through which a tether line can be pulled.

[0088]

[0118] Guidewire management device 2200 or 2300 may further include one or more guidewire conduit clips 2258 or 2358 configured to hold various portions of guidewire conduit 2250 or 2350 therein. Advantageously, guidewire conduit clip 2258 or 2358 holds guidewire conduit 2250 or 2350 in a coiled configuration.

[0089]

[0119] With respect to guidewire management device 2200, guidewire 102 is disposed within splittable casing 1204 when within guidewire conduit 2350, and a tether line separates from guidewire 102 extending through an opening in guidewire conduit 2250 proximal to second sleeve 2220. The tether is configured to route guidewire 102 distally through first sleeve 2210 and out of guidewire management device 2200 as the tether line is pulled from the opening in guidewire conduit 2250 and away from guidewire management device 2200. As the tether line is pulled out of the opening in guidewire conduit 2250, additional splittable casing 1204 separates from guidewire 102 before guidewire 102 exits first sleeve 2210. Proximal routing of guidewire 102 through first sleeve 2210 and into guidewire management device 2200 can be accomplished by a thumbwheel, a ridge, or a knob and guidewire gripping wheel, depending on which features, if any, are present on guidewire management device 2200. Without a thumbwheel, ridge, or knob and guidewire gripping wheel, guidewire management device 2200 is configured for manual removal of guidewire 102 from the patient.

[0090]

[0120] With respect to guidewire management device 2300, guidewire 102 is either bare or disposed within splittable casing 1204 while within guidewire conduit 2350. If guidewire 102 is bare, a proximal portion of tether line 2362 (e.g., a cord or wire) is coupled to the proximal portion of guidewire 102 within guidewire conduit 2350. If guidewire 102 is disposed within splittable casing 1204, tether line 2362 is separate from guidewire 102, similar to the splittable casing of guidewire management device 2200. In either case, a distal portion of tether line 2362 can extend from guidewire conduit 2350, through tether channel 2361 extending through handle 2340, and out an opening in handle 2340. A distal portion of tether line 2362, such as a distal end of tether line 2362, can be coupled to tether handle 2364, as shown. Tether 2360 is configured to route guidewire 102 distally through first sleeve 2310 and out of guidewire management device 2300 as tether line 2362 is pulled from an opening in handle 2340 and away from guidewire management device 2300. As an alternative to tether handle 2364, the distal portion of tether line 2362 is coupled to a slider disposed in a slot in handle 2340, thereby providing at least an alternative user interface for distally routing guidewire 102 out of guidewire management device 2300. The slider can have a bifurcated clip slidably disposed around the tether line 2362 so that when the slider is pressed into the narrow slider channel of the handle 2340 inside the slot and simultaneously moved distally, the slider grasps the tether line 2362 and sends the guidewire 102 distally through the first sleeve 2310 and out of the guidewire management device 2300.As the tether line 2362 is pulled out of the opening in the handle 2340, or as the slider is advanced if the guidewire 102 is disposed within the splittable casing 1204, the additional splittable casing 1204 separates from the guidewire 102 before the guidewire 102 exits the first sleeve 2310. Proximal routing of the guidewire 102 through the first sleeve 2310 and into the guidewire management device 2200 can be accomplished by pushing the tether line 2362 of the tether 2360 into the tether channel 2361 if the tether line 2362 is sufficiently stiff (e.g., is a wire), or by pushing the slider into the narrow slider channel of the handle 2340 and simultaneously moving the slider proximally. Alternatively, routing the guidewire 102 proximally through the first sleeve 2310 and into the guidewire management device 2200 may be accomplished by a thumbwheel, a ridge, or a knob and guidewire gripping wheel, depending on which features, if any, are present on the guidewire management device 2300. Without a sufficiently stiff tether line 2362, or without a slider, thumbwheel, ridge, or knob and guidewire gripping wheel, the guidewire management device 2300 is configured to manually remove the guidewire 102 from the patient.

[0091]

[0121] Referring to Figures 16 and 17 to describe at least some of the unique features of guidewire management device 2400, guidewire management device 2400 has a handle 2440, a guidewire 102 disposed within a sterile barrier (e.g., bag 104 or divisible casing 1204), a first sleeve 2410 formed within a distal portion of handle 2440, a second sleeve 2420 formed within a proximal portion of handle 2440, and a tether 2460 coupled to the proximal portion of guidewire 102.

[0092]

[0122] Handle 2440 is similar to handle 640 described above, although there may be differences in one or more design elements, such as tether channel 2461 extending through at least a portion of handle 2440, which carries tether line 2462 (e.g., cord, wire, etc.) of guidewire management device 2400. Accordingly, the description provided above of handle 640 should be understood to extend to handle 2440 as if handle 2440 were included in the description of handle 640.

[0093]

[0123] Although there may be possible differences in one or more design elements, first sleeve 2410 is similar to first sleeve 110, 610, or 710 described above. Accordingly, the descriptions provided above for first sleeve 110, 610, and 710 should be understood to extend to first sleeve 2410 as if first sleeve 2410 were included in the descriptions of first sleeve 110, 610, and 710.

[0094]

[0124] Although there may be possible differences in one or more design elements, second sleeve 2420 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeve 120, 620, and 720 should be understood to extend to second sleeve 2420 as if second sleeve 2420 were included in the descriptions of second sleeve 120, 620, and 720.

[0095]

[0125] Guidewire management device 2200 or 2300 can have a membrane 2406 or capsule 2446 extending over guidewire 102 between first sleeve 2410 and second sleeve 2420, thereby maintaining sterility of guidewire 102 between first sleeve 2410 and second sleeve 2420 following removal of bag 104 or dividable casing 1204, which occurs within bore 2422 in the proximal portion of handle 2440. If guidewire management device 2400 has membrane 2406, guidewire management device 2400 can further have a thumbwheel or ridge, such as ridge 2042 or 2142, described above in connection with guidewire management device 2000 or 2100. The thumbwheel may be configured to at least route guidewire 102 proximally into guidewire management device 2400, while tether 2460 is configured to route guidewire 102 distally and out of guidewire management device 2400, as described below. Similarly, the ridge may be configured to at least route guidewire 102 proximally and into guidewire management device 2400, as described above in connection with guidewire management device 2000 or 2100. If guidewire management device 2400 has capsule 2446, guidewire management device 2400 may further have a knob coupled to the guidewire gripping wheel, such as knob 1744, and guidewire gripping wheel 1742, as described above in connection with guidewire management device 1700. As described above in connection with guidewire management device 1700, the knob and guidewire gripping wheel may be configured to at least route guidewire 102 proximally into guidewire management device 2400, while tether 2460 is configured to route the guidewire distally and out of guidewire management device 2400, as described below.

[0096]

[0126] When guidewire 102 is disposed within bag 104, a proximal portion of tether line 2462 is coupled to a proximal portion of guidewire 102. Additionally, a distal portion of tether line 2462 extends from its attachment point to guidewire 102, through a tether channel 2461 extending through handle 2440, and out an opening in handle 2440. A distal portion of tether line 2462, such as a distal end of tether line 2462, can be coupled to tether handle 2464, as shown. Tether 2460 is configured to route guidewire 102 distally and out of guidewire management device 2400 via first sleeve 2410 as tether line 2462 is pulled out of the opening in handle 2440 and away from guidewire management device 2400. As an alternative to the tether handle 2460, a distal portion of the tether line 2462 is coupled to a slider disposed in a slot in the handle 2440, thereby providing an alternative user interface for at least routing the guidewire 102 distally and out of the guidewire management device 2400, as described above for the guidewire management device 2400. As the tether line 2462 is pulled out of an opening in the handle 2440 or the slider is advanced, the guidewire 102 separates from and exits the bag 104 in the second sleeve 2420, travels to the first sleeve 2410, and exits the guidewire management device 2400 via the first sleeve 2410. Meanwhile, the bag 104 pleats within the bore 2422 of the second sleeve 2420 simultaneously as the guidewire 102 separates from and exits the bag 104. The guidewire 102 can be routed proximally through the first sleeve 2410 and into the guidewire management device 2400 by pushing the tether line 2462 of the tether 2460 into the tether channel 2461 if the tether line 2462 is sufficiently stiff (e.g., a wire), or by pushing the slider inside the slot into the narrow slider channel of the handle 2440 and simultaneously moving the slider proximally.Alternatively, routing the guidewire 102 proximally through the first sleeve 2410 and into the guidewire management device 2400 may be accomplished by a thumbwheel, a ridge, or a knob and guidewire gripping wheel, depending on which features, if any, are present on the guidewire management device 2400. Without a sufficiently stiff tether line 2362, or without a slider, thumbwheel, ridge, or knob and guidewire gripping wheel, the guidewire management device 2400 is configured to manually remove the guidewire 102 from the patient.

[0097]

[0127] When guidewire 102 is disposed within splittable casing 1204, tether line 2462 is splittable casing 1204 that separates from guidewire 102, similar to the splittable casing of guidewire management device 2200. Additionally, a distal portion of tether line 2462 extends from its attachment point to guidewire 102 (e.g., within bore 2422), through tether channel 2461 that extends through handle 2440, and out an opening in handle 2440. A distal portion of tether line 2462, such as a distal end of tether line 2462, can be coupled to tether handle 2464, as shown. Tether 2460 is configured to route guidewire 102 distally and out of guidewire management device 2400 via first sleeve 2410 as tether line 2462 is pulled from the opening in handle 2440 and away from guidewire management device 2400. As an alternative to the tether handle 2460, a distal portion of the tether line 2462 is coupled to a slider disposed in a slot in the handle 2440 described above. As the tether line 2462 is pulled out of an opening in the handle 2440 or as the slider is advanced, the additional separable casing 1204 separates from the guidewire 102 in the second sleeve 2420 (e.g., in the bore 2422) before the guidewire 102 reaches the first sleeve 2410 and exits the guidewire management device 2400 via the first sleeve 2410. Routing the guidewire 102 proximally through the first sleeve 2410 and into the guidewire management device 2400 can be accomplished by a slider, a thumbwheel, a ridge, or a knob and guidewire gripping wheel, depending on which features, if any, the guidewire management device 2400 has. Without the thumbwheel, ridge, or knob and guidewire gripping wheel, guidewire management device 2400 is configured to manually remove guidewire 102 from the patient.

[0098]

[0128] 18-23 to describe at least some of the unique features of guidewire management device 2600, guidewire management device 2600 includes a handle 2640, a guidewire 102, a tether line 2662 at least partially disposed within a sterile barrier 104 (e.g., bag 104) and coupled to a proximal portion of guidewire 102, a first sleeve 2610 formed within a distal portion of handle 2640, and a tether line 2662 coupled to a proximal portion of guidewire 102. 40, a second sleeve 2620 formed in the proximal portion of the handle 2640, a third sleeve 2611 in the distal portion of the handle 2640 adjacent to the first sleeve 2610, a fourth sleeve 2621 in the proximal portion of the handle 2640 adjacent to the second sleeve 2620, a thumbwheel 2642 between the first sleeve 2610 and the second sleeve 2620, and a guidewire-tether conduit 2650 coupled to the proximal portion of the handle 2640.

[0099]

[0129] The handle 2640 is similar to the handle 640 described above, although there are possible differences in one or more design elements, such as a tether channel 2661 extending through at least a portion of the handle 2640, which carries the drive wire or tether line 2662 of the guidewire management device 2600. Additionally, the handle 2640 is similar to the handle 1740 in that the guidewire 102 extends between the first sleeve 2610 and the second sleeve 2620 but is generally disposed within the handle 2640 adjacent the tether channel 2661, and the handle 2640 functions as an extension of the sterility barrier 104 to maintain the sterility of the guidewire 102 between the first sleeve 1710 and the second sleeve 1720. Therefore, the descriptions provided above for handles 640 and 1740 should be understood to extend to handle 2640 as if handle 2640 were included in the descriptions of handles 640 and 1740 .

[0100]

[0130] A proximal portion of tether line 2662 is coupled to a proximal portion of guidewire 102 by a slug 2666 or some other mass (e.g., a ball), and tether line 2662 and guidewire 102 are fixedly attached (e.g., welded) to this slug 2666 or some other mass (e.g., ball). Alternatively, the proximal portion of tether line 2662 is fixedly attached (e.g., welded) directly to the proximal portion of guidewire 102. In any event, the proximal portion of the tether line 2662 extends from the slug 266 (or similar) or from where it is directly attached to the proximal portion of the guidewire 102, through the sterile barrier 104 within the guidewire-tether conduit 2650, through the tether channel 2661 extending through the handle 2640, and out the opening in the third sleeve 2611, so that the tether line 2662 never contacts the guidewire 102 except in embodiments where the proximal portion of the tether line 2662 is fixedly attached (e.g., welded) directly to the proximal portion of the guidewire 102.

[0101]

[0131] The tether line 2662 is configured to route the guidewire 102 distally and out of the guidewire management device 2600 via the first sleeve 2610 as the tether line 2662 is pulled out of the opening in the third sleeve 2611 and away from the guidewire management device 2600. The guidewire-tether conduit 2650 is configured to facilitate distal routing of the guidewire 102 out of the guidewire management device 2600 by limiting the degrees of freedom that the tether line 2662 and the guidewire 102 would otherwise have to only such distal routing (and even proximal routing). As the tether line 2662 is pulled out of the third sleeve 2611, the sterility barrier 104 within the guidewire-tether conduit 2650 pleats within the distal portion of the guidewire-tether conduit 2650. Tether line 2662 is further configured to route guidewire 102 proximally through first sleeve 2610 and into guidewire management device 2600 as tether line 2662 is pushed toward guidewire management device 2600 and into the opening of third sleeve 2611. Concurrent with pushing tether line 2662 into third sleeve 2611, sterile barrier 104 within guidewire-tether conduit 2650 unpleats from the distal portion of guidewire-tether conduit 2650 to retrieve guidewire 102 and maintain sterility of guidewire 102.

[0102]

[0132] Although there may be possible differences in one or more design elements, the first sleeve 2610 is 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 sleeve 2610 as if the first sleeve 2610 were included in the descriptions of the first sleeves 110, 610, and 710.

[0103]

[0133] Although there may be possible differences in one or more design elements, second sleeve 2620 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeve 120, 620, and 720 should be understood to extend to second sleeve 2620 as if second sleeve 2620 were included in the descriptions of second sleeve 120, 620, and 720.

[0104]

[0134] The third sleeve 2611 is configured with a lumen for pulling or advancing the tether line 2662 distally and out of the guidewire management device 2600. The lumen of the third sleeve 2611 corresponds to a portion of the tether channel 2661. The third sleeve 2611 is further configured to advance or retract the tether line 2662 proximally and into the guidewire management device 2600.

[0105]

[0135] The fourth sleeve 2621 is configured with a lumen for pulling or advancing the tether line 2662 distally, such as by cooperating with the third sleeve 2611 to route the tether line 2662 distally and out of the guidewire management device 2600. The lumen of the fourth sleeve 2621 corresponds to a portion of the tether channel 2661. The third sleeve 2611 is further configured with the third sleeve 2611 to proximally route or retract the tether line 2662 proximally, such as by cooperating with the third sleeve 2611 to route the tether line 2662 proximally and out of the guidewire management device 2600.

[0106]

[0136] Although there may be possible differences in one or more design elements, thumbwheel 2642 is similar to thumbwheel 642 or 742 described above. Accordingly, the descriptions provided above for thumbwheel 642 and 742 should be understood to extend to thumbwheel 2642 as if thumbwheel 2642 were included in the descriptions of thumbwheel 642 and 742. However, thumbwheel 2642 is configured to assist in distally routing tether line 2662 (but not guidewire 102) through third sleeve 2611 and out of guidewire management device 2600 when thumbwheel 2642 is used instead of pulling tether line 2662. Thumbwheel 2642 may provide finer control over distal routing of tether line 2662, and thus guidewire 102, compared to pulling tether line 2662. The thumbwheel 2642 is further configured to assist in routing the tether line 2662 proximally through the third sleeve 2611 and into the guidewire management device 2600 .

[0107]

[0137] In cooperation with thumbwheel 2642, or in coordination with pulling tether line 2662, guidewire-tether conduit 2650 is configured to route both guidewire 102 and tether line 2662 through guidewire management device 2600 while routing guidewire 102 distally and out of guidewire management device 2600. Guidewire-tether conduit 2650 may be opaque or translucent. If guidewire-tether conduit 2650 is translucent, guidewire-tether conduit 2650 is configured to allow visualization of both guidewire 102 and tether line 2662 while routing them through guidewire management device 2600. Similarly, in cooperation with thumbwheel 2642, guidewire-tether conduit 2650 is configured to receive both guidewire 102 and tether line 2662 therein while routing guidewire 102 proximally into guidewire management device 2600. Again, guidewire-tether conduit 2650 may be opaque or translucent. If guidewire-tether conduit 2650 is translucent, guidewire-tether conduit 2650 is configured to allow visualization of both guidewire 102 and tether line 2662 while receiving guidewire 102 and tether line 2662 within guidewire-tether conduit 2650.

[0108]

[0138] Referring to FIG. 24 to describe at least some of the unique features of guidewire management device 2700, guidewire management device 700 has a handle 2740, a guidewire 102, a first sleeve 2710 formed within a distal portion of handle 2740, a second sleeve 2720 formed within a proximal portion of handle 2740, and an exposed thumbwheel 2742 coupled to a guidewire gripping wheel 2744 hidden between first sleeve 2710 and second sleeve 2720, wherein hidden guidewire gripping wheel 2744 is configured to grip guidewire 102 and feed guidewire 102 distally through first sleeve 2710 and out of or into guidewire management device 2700 when exposed thumbwheel 2742 is turned. Guidewire 102 extends between first sleeve 2710 and second sleeve 2720 but is disposed within handle 2740, which acts as a sterility barrier to maintain the sterility of guidewire 102 between first sleeve 2710 and second sleeve 2720. In addition to handle 2740, guidewire management device 2700 itself has a guidewire conduit 2750 coupled to second sleeve 2720 configured to maintain the sterility of guidewire 102 outside of handle 2740 having first sleeve 2710 and second sleeve 2720. Because both handle 2740 and guidewire conduit 2750 are configured to maintain the sterility of guidewire 102, a sterility barrier such as bag 104 or splittable casing 1204 is not required for guidewire management device 2700.

[0109]

[0139] Although there may be possible differences in one or more design elements, handle 2740 is similar to handle 640 described above. However, handle 2740 has similar features to handle 1740 in that handle 2740 is configured to maintain the sterility of guidewire 102. Additionally, given the distance to exposed thumbwheel 2742 from one side of handle 2740 as used by a left-handed clinician, handle 2740 may be better suited for use by the clinician's right hand rather than for ambidexterity. In any event, the description provided above of handle 640 should be understood to extend to handle 2740 as if handle 2740 were included in the description of handle 640. This also includes the description for channel 641 because handle 2740 also has channel 2741.

[0110]

[0140] Although there may be possible differences in one or more design elements, the first sleeve 2710 is 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 sleeve 2710 as if the first sleeve 2710 were included in the descriptions of the first sleeves 110, 610, and 710.

[0111]

[0141] Although there may be possible differences in one or more design elements, second sleeve 2720 is similar to second sleeve 120, 620, or 720 described above. Accordingly, the descriptions provided above for second sleeve 120, 620, and 720 should be understood to extend to second sleeve 2720 as if second sleeve 2720 were included in the descriptions of second sleeve 120, 620, and 720.

[0112]

[0142] The combination of exposed thumbwheel 2742 and hidden guidewire gripping wheel 2744 is configured to route guidewire 102 distally out of guidewire management device 2700 or route guidewire 102 proximally into guidewire management device 2700. In practice, exposed thumbwheel 2742 has an axle (e.g., as a single piece) disposed within handle 2740, and hidden guidewire gripping wheel 2744 is fixedly coupled to this axle, such that when exposed thumbwheel 2742 is rotated relative to handle 2740, hidden guidewire gripping wheel 2744 rotates with exposed thumbwheel 2742. Alternatively, hidden guidewire gripping wheel 2744 has an axle (e.g., as a single piece) disposed within handle 2740, and exposed thumbwheel 2742 is fixedly coupled to this axle, such that when exposed thumbwheel 2742 is rotated relative to handle 2740, hidden guidewire gripping wheel 2744 rotates with exposed thumbwheel 2742. Still alternatively, exposed thumbwheel 2742 and hidden guidewire gripping wheel 2744 are independently fixedly coupled to axles disposed within handle 2740, such that when exposed thumbwheel 2742 is rotated relative to handle 2740, hidden guidewire gripping wheel 2744 rotates with exposed thumbwheel 2742. Further alternatively, exposed thumbwheel 2742 and hidden guidewire gripping wheel 2744 are a single piece having an axis disposed within handle 2740, such that when exposed thumbwheel 2742 is rotated relative to handle 2740, hidden guidewire gripping wheel 2744 rotates with exposed thumbwheel 2742. In this manner, the combination of exposed thumbwheel 2742 and hidden guidewire gripping wheel 2744 is configured to assist in routing guidewire 102 distally through first sleeve 2710 and out of guidewire management device 2700, such as when exposed thumbwheel 2742 is rotated toward first sleeve 2710.The combination of exposed thumbwheel 2742 and hidden guidewire gripping wheel 2744 is configured to assist in routing guidewire 102 proximally through first sleeve 2710 and into guidewire management device 2700, such as when exposed thumbwheel 2742 is rotated toward second sleeve 2720. Hidden guidewire gripping wheel 2744 has teeth configured to grip guidewire 102 using friction created by gently compressing guidewire 102 against compression wheel 2746 to route guidewire 102 distally out of guidewire management device 2700 or proximally into guidewire management device 2700.

[0113]

[0143] Guidewire conduit 2750 is configured to route guidewire 102 distally through second sleeve 2720 and into guidewire management device 2700 during distal routing of guidewire 102 out of guidewire management device 2700, and to receive guidewire 102 proximally through second sleeve 2720 within guidewire conduit 2750 again during proximal routing of guidewire 102 into guidewire management device 2700. Guidewire conduit 2750 may be opaque or translucent depending on the polymeric material selected. If the guidewire conduit 2750 is translucent, the guidewire conduit 2750 is configured to allow visualization of the guidewire 102 while it is being advanced distally and out of the guidewire management device 2700, or while it is being advanced proximally and into the guidewire management device 2700 while the guidewire 102 is again received within the guidewire conduit 2750.

[0114]

[0144] Although not shown, guidewire management device 2700 may further include one or more guidewire conduit clips configured to hold various portions of guidewire conduit 2750 therein. Advantageously, the guidewire conduit clips may hold guidewire conduit 2750 in a coiled configuration, thereby allowing an otherwise elongated guidewire conduit 2750 to be packed into a compact space. method

[0145] 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.

[0115]

[0146] 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.

[0116]

[0147] 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.

[0117]

[0148] In practice, guidewires 102 may be advanced into first sleeve 110 or 610 and out of guidewire management device 100 or 600 by pinching 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 may be advanced into first sleeve 110 and out of guidewire management device 300 by pinching 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.

[0118]

[0149] 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.

[0119]

[0150] 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.

[0120]

[0151] In practice, guidewires 102 may be retracted into guidewire management device 100 or 600 through first sleeve 110 or 610 by pinching 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 pinching 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.

[0121]

[0152] 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.

[0122]

[0153] 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: 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, the second sleeve extending between the first and second sleeves with the guidewire disposed within a capsule that maintains sterility of the guidewire; and a guidewire gripping wheel having teeth disposed under the guidewire between the first sleeve and the second sleeve, the teeth configured to grip the guidewire by pressing the guidewire against the capsule when the guidewire gripping wheel is rotated; and a knob coupled to the wheel 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 when the knob is rotated clockwise or counterclockwise, respectively; and A guidewire management device comprising:

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

4. 4. The guidewire management device of claim 1, 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.

5. 5. The guidewire management device of claim 1, further comprising a guidewire conduit coupled to the second sleeve configured to route the guidewire distally through the second sleeve and into the guidewire management device, the guidewire conduit configured to maintain sterility of the guidewire outside of the first sleeve, the capsule, and the second sleeve.

6. The guidewire management device of claim 5 , wherein the handle has a channel configured to retain the guidewire conduit therein when the guidewire conduit is in a coiled configuration.

Images