Guidewire management device and method thereof

Abstract

Guidewire management devices and methods thereof are disclosed herein. A guidewire management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured to feed the guidewire distally out of the guidewire management device. The first sleeve can also be configured to feed the guidewire proximally into the guidewire management device. The second sleeve can be proximal to the first sleeve in the guidewire management device. The second sleeve can be configured to feed the guidewire in unison with the first sleeve. At least a 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. Methods of guidewire management devices can include methods of using guidewire management devices such as the aforementioned guidewire management devices.

Description

[0001] Priority

[0002] This application claims priority benefit of U.S. Provisional Application No. 62 / 926,327, filed October 25, 2019, which is incorporated by reference in its entirety into the present application. BACKGROUND

[0003] Catheters are commonly placed in a patient’s blood vessels using the Seldinger technique, which involves inserting a hollow needle into the blood vessel, inserting a guidewire into 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 the catheter is properly placed in the patient’s vasculature. The guidewire is then removed from the patient.

[0004] Guidewires used in accordance with the Seldinger technique are commonly packaged in a coiled-tube dispenser to maintain the guidewire sterile and to make it easier to handle the guidewire. However, inserting such a guidewire from the dispenser into a hollow needle requires two hands. Specifically, one hand is needed to hold both the needle and an engagement piece configured to guide the guidewire into the needle, while the other hand is needed to grasp the guidewire and guide the guidewire from the dispenser into the needle. The more the guidewire is handled, the more the chance of contaminating or damaging the guidewire. In view of the foregoing, there is a need for better guidewire management in medical procedures such as those requiring the Seldinger technique.

[0005] Disclosed herein are guidewire management devices and methods thereof that address the foregoing. SUMMARY

[0006] Disclosed herein is a guidewire management device that, in some embodiments, includes a guidewire, a first sleeve, and a second sleeve. The first sleeve is configured to feed the guidewire distally out of the guidewire management device. The first sleeve is also configured to feed the guidewire proximally into the guidewire management device. The second sleeve is proximal to the first sleeve in the guidewire management device. The second sleeve is configured to feed the guidewire in unison with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve is disposed within a sterile barrier configured to maintain sterility of the guidewire.

[0007] In some embodiments, the first sleeve has a distal end portion configured as a male connector having a Luer taper for connecting the first sleeve to a complementary female connector.

[0008] In some embodiments, the first sleeve is configured to straighten the guidewire when feeding the guidewire proximally into the guidewire management device.

[0009] In some embodiments, the first sleeve includes a seal configured to block fluid from entering or escaping the guidewire management device when the guidewire is fed proximally into the guidewire management device.

[0010] In some embodiments, the first sleeve has a proximal end portion that includes a bore configured to receive a distal end portion of the aseptic barrier.

[0011] In some embodiments, the second sleeve has a distal end portion that includes a bore configured to receive a proximal end portion of the aseptic barrier.

[0012] In some embodiments, the second sleeve has a proximal end portion that includes another bore configured to block one end of the guidewire from passing completely through the second sleeve.

[0013] In some embodiments, the guidewire has a distal end portion that includes a 'J' tip configured to straighten when the tip of the guidewire enters the first sleeve when the guidewire is fed proximally into the guidewire management device.

[0014] In some embodiments, the guidewire has a proximal end portion that includes a ball tip configured to block the guidewire from passing completely through the second sleeve.

[0015] In some embodiments, the aseptic barrier is a pleated bag. The bag is configured to unpleat when the bag is pulled out of the second sleeve (while the guidewire is fed distally out of the guidewire management device). The bag is also configured to pleat when the bag is inserted into the first sleeve (while the guidewire is fed distally out of the guidewire management device).

[0016] In some embodiments, the aseptic barrier is a bellowed boot configured to stretch from an equilibrium state and relax back to the equilibrium state while the guidewire is fed distally out of the guidewire management device.

[0017] Also disclosed herein is a guidewire management device that, in some embodiments, includes a guidewire, a frame including a pair of tubular rails, a guidewire conduit that passes through the tubular rails, a first sleeve mounted between each of the pair of rails, and a second sleeve mounted between each of the pair of rails proximal to the first sleeve. The guidewire includes a distal end portion including a 'J' tip and a proximal end portion including a ball end. The guidewire is disposed within the guidewire conduit. The first sleeve is configured to feed the guidewire distally out of the guidewire management device. The first sleeve is also configured to feed the guidewire proximally into the guidewire management device. The second sleeve is configured to feed the guidewire in unison with the first sleeve. At least a length of the guidewire that extends between the first sleeve and the second sleeve is disposed within a sterile barrier configured to maintain sterility of the guidewire.

[0018] In some embodiments, the first sleeve has a distal end portion configured as a male connector having a luer fitting for connecting the first sleeve to a complementary female connector.

[0019] In some embodiments, the first sleeve is configured to straighten the tip of the guidewire as the tip enters the first sleeve when feeding the guidewire proximally into the guidewire management device.

[0020] In some embodiments, the second sleeve has a proximal end portion including a bore having a constriction configured to capture the ball end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

[0021] In some embodiments, the guidewire conduit has a proximal end portion including a plug configured to prevent the ball end of the guidewire from passing through an opening in the proximal end of the guidewire conduit. Preventing the ball end of the guidewire from passing through the opening in the guidewire conduit prevents the tip of the guidewire from passing completely through the first sleeve and reforming the 'J' tip when feeding the guidewire proximally into the guidewire management device.

[0022] In some embodiments, the sterile barrier is a pleated bag. The bag is configured to unpleat when it is pulled out of the bore in the distal end portion of the second sleeve (while feeding the guidewire distally out of the guidewire management device). The bag is also configured to pleat when it is inserted into the bore in the proximal end portion of the first sleeve (while feeding the guidewire distally out of the guidewire management device).

[0023] In some embodiments, the sterile barrier is a bellows configured to stretch from an equilibrium state and relax back to the equilibrium state while feeding the guidewire distally out of the guidewire management device.

[0024] Also disclosed herein is a guidewire management device that in some embodiments includes a handle, a guidewire, a first sleeve formed in a distal end portion of the handle, a second sleeve formed in a proximal end portion of the handle, and a thumb wheel arranged below the guidewire between the first sleeve and the second sleeve. At least a length of the guidewire that extends between the first sleeve and the second sleeve is arranged within a sterile barrier configured to maintain sterility of the guidewire. The thumb wheel is configured to assist feeding the guidewire distally out of the guidewire management device by means of the first sleeve. The thumb wheel is also configured to assist feeding the guidewire proximally into the guidewire management device by means of the first sleeve.

[0025] In some embodiments, the first sleeve has a distal end portion configured as a male connector having a luer fitting for connecting the first sleeve to a complementary female connector.

[0026] In some embodiments, the first sleeve is configured to straighten a 'J' shaped tip in a distal end portion of the guidewire as the tip of the guidewire enters the first sleeve when feeding the guidewire proximally into the guidewire management device.

[0027] In some embodiments, the second sleeve has a proximal end portion comprising a bore having a constriction configured to capture a ball tip of the guidewire and to prevent the guidewire from passing completely through the second sleeve.

[0028] In some embodiments, the sterile barrier is a pleated bag over the entire guidewire except within or distal to the first sleeve. The bag is configured to be pleated as it is inserted into a bore in a proximal end portion of the first sleeve (while feeding the guidewire distally out of the guidewire management device).

[0029] In some embodiments, a proximal end of the bag is closed, providing a proximal limit to feeding the guidewire proximally into the guidewire management device by means of the first sleeve. The proximal limit established by the proximal end of the bag is configured to prevent the 'J' shaped tip of the guidewire from passing completely through the first sleeve when feeding the guidewire proximally into the guidewire management device by means of the first sleeve.

[0030] Also disclosed herein is a method of guidewire management that in some embodiments includes a connecting step of connecting a first sleeve of a 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 having a luer fitting. The method further includes a pushing step of pushing 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 arranged within a sterile barrier configured to maintain sterility of the guidewire until being fed into the first sleeve.

[0031] In some embodiments, the advancing step includes pinching the guidewire within a sterile barrier and pushing the guidewire into the first sleeve with a hand. The sterile barrier is a pleated bag or bellows cover.

[0032] In some embodiments, the advancing step includes pressing the guidewire within a sterile barrier onto a thumb wheel and rolling the thumb wheel to advance the guidewire into the first sleeve. The sterile barrier is a pleated bag.

[0033] In some embodiments, the method further includes a ceasing step of ceasing advancing the guidewire into the insertion site of the patient when the ball end of the proximal portion of the guidewire is captured in the constriction of the aperture in the proximal portion of the second sleeve of the guidewire management device.

[0034] In some embodiments, the method further includes withdrawing the guidewire from the insertion site of the patient through the hub of the medical device and into the first sleeve. The seal in the first sleeve blocks fluid from entering or escaping the guidewire management device when the guidewire is withdrawn from the insertion site.

[0035] In some embodiments, the distal portion of the guidewire includes a 'J' tip configured to straighten as the tip of the guidewire enters the first sleeve when the guidewire is withdrawn from the insertion site.

[0036] In some embodiments, the method further includes ceasing withdrawing the guidewire from the insertion site of the patient when the proximal end of the guidewire abuts a plug in the proximal portion of the guidewire conduit of the guidewire management device.

[0037] These and other features of the concepts provided herein will become more apparent from the accompanying drawings and the following description in which specific embodiments of these concepts are described in more detail. BRIEF DESCRIPTION OF DRAWINGS

[0038] Figure 1 A first guidewire management device is shown in accordance with some embodiments.

[0039] Figure 2 A longitudinal cross-section of a first guidewire management device is shown in accordance with some embodiments.

[0040] Figure 3 A second guidewire management device is shown in accordance with some embodiments.

[0041] Figure 4 A longitudinal cross-section of a second guidewire management device is shown in accordance with some embodiments.

[0042] Figure 5 A ball end of a guidewire distal of a plug in a guidewire conduit is shown in accordance with some embodiments.

[0043] Figure 6 A third guidewire management device is shown in accordance with some embodiments.

[0044] Figure 7 A detailed view of a handle of a third guidewire management device is shown in accordance with some embodiments.

[0045] Figure 8 A longitudinal cross-section of a third guidewire management device is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0046] Before particular embodiments are disclosed in more detail, it is to be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It is also to be understood that particular embodiments disclosed herein can have features that can be readily separated from the particular embodiments into individual features or claims or can be optionally combined into further aspects or claims with other features described herein or claimed dependent thereto.

[0047] With respect to the terms used herein, it is also to be understood that these terms are used for the purpose of describing some particular embodiments and that these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps and do not supply a serial or numerical limitation. For example, "first," "second," and "third" features or steps need not be in that order and the particular embodiments including such features or steps need not have three features or steps. Labels such as "left," "right," "front," "back," "top," "bottom," and the like are used for convenience and are not intended to imply any particular fixed location, orientation, or direction. On the contrary, such terms are used in connection with the exemplary embodiments to reflect relative locations and / or orientations for purposes of illustration only and are not intended to limit the scope of the concepts provided herein to only such relative locations or orientations.

[0048] A "proximal," "proximal portion," or "proximal end portion" of, for example, a catheter includes a portion of the catheter intended to be proximate to a clinician when the catheter is used on a patient. Likewise, a "proximal length" of, for example, a catheter includes a length of the catheter intended to be proximate to a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter intended to be proximate to a clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include a proximal end of the catheter; however, a proximal portion, proximal end portion, or proximal length of a catheter need not include a proximal end of the catheter. That is, unless the context indicates otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a distal portion or a distal length of the catheter.

[0049] "distal portion" or "distal length" of a catheter includes the length of the catheter that is intended to be near or in a patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or in a patient when the catheter is used on a patient. The distal, distal portion, or distal length of a catheter can include the distal end of the catheter; however, the distal, distal portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, the distal, distal portion, or distal length of a catheter is not the terminal portion or length of the catheter.

[0050] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art.

[0051] As noted above, better guidewire management is needed in medical procedures such as those requiring Seldinger techniques. Disclosed herein are guidewire management devices and methods that address the above.

[0052] Guidewire management device

[0053] Figure 1 and 2 A first guidewire management device 100 according to some embodiments is shown. Figure 3 and 4 A second guidewire management device 300 according to some embodiments is shown. Figures 6-8 A third guidewire management device 600 according to some embodiments is shown. The guidewire management devices 100, 300, and 600 are first described below, with emphasis on their common features. Subsequently, the guidewire management devices 100, 300, and 600 are described below primarily with respect to their unique features.

[0054] As shown, the guidewire management device 100, 300, or 600 includes a guidewire 102, a first sleeve 110 or 610, and a second sleeve 120 or 620.

[0055] The first hub 110 or 610 is configured to feed or advance the guidewire 102 distally out of the guidewire management device 100, 300, or 600. The first hub 110 or 610 has a distal end portion that is configured to be a male connector having a luer connector for connecting the first hub 110 or 610 to a complementary female connector, such as a connector of a hub of a hollow needle, which facilitates single-handed operation of the guidewire management device 100, 300, or 600, including feeding the guidewire 102 distally out of the guidewire management device 100, 300, or 600. The first hub 110 or 610 also has a proximal end portion that includes a bore 112 or 712 configured to accommodate or collect a distal end portion of the sterile barrier 104 when the guidewire 102 is fed distally out of the guidewire management device 100, 300, or 600.

[0056] The first hub 110 or 610 is also configured to feed or retract the guidewire 102 proximally into the guidewire management device 100, 300, or 600. The first hub 110 or 610 is configured to straighten the guidewire 102, such as a 'J' tip thereof (see FIG. 1), when the guidewire 102 is fed proximally into the guidewire management device 100, 300, or 600. Figure 7 and 8 The first hub 110 or 610 can include a seal, such as an 'O' ring 114 or 714, configured to block fluid (e.g., blood) from entering the guidewire management device 100, 300, or 600 when the guidewire is fed proximally into the guidewire management device 100, 300, or 600. The seal, e.g., the 'O' ring 114 or 714, is also configured to block fluid (e.g., air) from escaping the guidewire management device 100, 300, or 600 when the guidewire is fed proximally into the guidewire management device 100, 300, or 600, thereby minimizing or eliminating the risk of air embolism.

[0057] The second hub 120 or 620 is proximal to the first hub 110 or 610 in the guidewire management device 100, 300, or 600, such that at least a length of the guidewire 102 extends between the first hub 110 or 610 and the second hub 120 or 620. The at least the length of the guidewire 102 extending between the first hub 110 or 610 and the second hub 120 or 620 is disposed within the sterile barrier 104.

[0058] The second sleeve 120 or 620 is configured to feed the guidewire 102 in unison with the first sleeve 110 or 610, such as feeding the guidewire 102 distally out of the guidewire management device 100, 300, or 600. The second sleeve 120 or 620 has a proximal end portion that optionally includes a hole 122. For example, the second sleeve 120 has a proximal end portion that includes a hole 122, while the second sleeve 620 has a proximal end portion that does not have such a hole. Whether the second sleeve 120 or 620 includes such a hole, the second sleeve 120 or 620 also includes a constriction 124, a recess 724, or similar stop device to prevent the end of the guidewire 102, such as its ball tip, from passing completely through the second sleeve 120 or 620 when the guidewire 102 is fed distally out of the guidewire management device 100, 300, or 600. Because the constriction 124, the recess 724, or similar stop device is configured to prevent the end of the guidewire 102 from passing completely through the second sleeve 120 or 620, the constriction 124, the recess 724, or similar stop device is also configured to prevent the guidewire from passing completely through the guidewire management device 100, 300, or 600 and into the patient, where the guidewire 102 can be lost.

[0059] The second sleeve 120 or 620 is also configured to feed the guidewire 102 in unison with the first sleeve 110 or 610 proximally into the guidewire management device 100, 300, or 600. The second sleeve 120 or 620 has a distal end portion that includes a hole 126 or 726 configured to accommodate the proximal end portion of the sterile barrier 104 or collect the proximal end portion of the sterile barrier 104 when the guidewire 102 is fed proximally into the guidewire management device 100, 300, or 600.

[0060] The guidewire 102 has a distal end portion and a proximal end portion.

[0061] The distal end portion of the guidewire 102 can include a 'J' tip configured to straighten when the tip of the guidewire 102 enters the first sleeve 110 or 610 when the guidewire 102 is fed proximally into the guidewire management device 100, 300, or 600. The 'J' tip is configured to reform the 'J' when released from its constriction (e.g., the first sleeve 110 or 610) when the guidewire 102 is fed distally out of the guidewire management device 100, 300, or 600. If the first sleeve 110 or 610 is connected to a complementary female connector, such as a female connector of a hub of a hollow needle, the tip of the guidewire 102 does not reform the 'J' until the tip distally exceeds the needle (such as in a blood vessel).

[0062] The proximal portion of the guidewire 102 can comprise a ball end configured to be stopped by the constriction 124, the recess 724 or similar stop means from the guidewire 102 passing completely through the second sleeve 120 or 620 when the guidewire 102 is fed distally out of the guidewire management device 100, 300 or 600.

[0063] The sterile barrier 104 is configured to maintain the sterility of the guidewire 102 while the guidewire 102 is disposed therein. Importantly, the guidewire never needs to be touched by the clinician during the procedure, thereby maintaining the sterility of the guidewire 102 and ensuring that the clinician remains free from contact with bodily fluids.

[0064] The sterile barrier 104 can be a pleated bag 105. The bag 105 is configured to not be pleated when the guidewire 102 is pulled out of the second sleeve 120 or 620 while it is being fed distally out of the guidewire management device 100 or 600. The bag 105 is also configured to be pleated when the guidewire 102 is inserted into the first sleeve 110 or 610 while it is being fed distally out of the guidewire management device 100 or 600. Likewise, the bag 105 is configured to not be pleated when the guidewire 102 is pulled out of the first sleeve 110 or 610 while it is being fed proximally into the guidewire management device 100 or 600. The bag 105 is also configured to be pleated when the guidewire 102 is inserted into the second sleeve 120 or 620 while it is being fed proximally into the guidewire management device 100 or 600.

[0065] With respect to at least the guidewire management device 600, the proximal end of the bag 105 is closed and optionally coupled to, for example, the ball end of the guidewire 102, which provides a proximal limit to the feeding of the guidewire 102 proximally into the guidewire management device 600 by means of the first sleeve 610. When the bag 105 is fully extended, the proximal limit established by the proximal end of the bag 105 is configured to prevent the 'J' shaped tip of the guidewire 102 from passing completely through the first sleeve 610 when the guidewire 102 is fed proximally into the guidewire management device 600 via the first sleeve 610. This is advantageous because it is particularly difficult to reinsert the 'J' shaped tip of the guidewire 102 back into the first sleeve 610 if the 'J' shaped tip of the guidewire 102 passes completely through the first sleeve 610 when the guidewire 102 is fed proximally into the guidewire management device 600.

[0066] A method for feeding or advancing the guidewire 102 distally out of the guidewire management device 100 or 600 is presented below. A method for feeding or retracting the guidewire 102 distally into the guidewire management device 100 or 600 is also presented below.

[0067] The sterile barrier 104 can be a bellows cover 305. The cover 305 is configured to repeatedly stretch from a balanced state and relax back to the balanced state while feeding the guidewire 102 distally out of the guidewire management device 300. Likewise, the cover 305 is configured to repeatedly stretch from a balanced state and relax back to the balanced state while feeding the guidewire 102 proximally into the guidewire management device 600.

[0068] A method for feeding or advancing the guidewire 102 distally out of the guidewire management device 300 is presented below. A method for feeding or retracting the guidewire 102 distally into the guidewire management device 300 is also presented below.

[0069] Referring to Figures 1-4 To describe some features unique to the guidewire management devices 100 and 300, the guidewire management devices 100 and 300 include a guidewire 102, a frame 140 including a pair of tubular rails 142, a guidewire conduit 144 that runs through the pair of rails 142, a first sleeve 110 mounted on a strut between each rail of the pair of rails 142, and a second sleeve 120 mounted on a strut between each rail of the pair of rails 142 proximal to the first sleeve 110. The guidewire 102 is disposed within the guidewire conduit 144.

[0070] Figure 5 A ball end of the guidewire 102 distal of the plug 145 in the guidewire conduit 144 is shown in accordance with some embodiments.

[0071] The guidewire conduit 144 has a proximal end portion that includes a plug 145 configured to block the ball end of the guidewire 102 from passing through an opening that would otherwise be in the proximal end of the guidewire conduit 144. Blocking the ball end of the guidewire 102 from passing through the opening in the guidewire conduit 144 prevents the tip of the guidewire 102 from passing completely through the first sleeve 110 and reforming a ‘J’-shaped tip when the guidewire 102 is fed proximally into the guidewire management device 100 or 300.

[0072] Referring to Figures 6-8 To describe some features unique to the guidewire management device 600, the guidewire management device 600 includes a handle 640, a guidewire 102, a first sleeve 610 formed in a distal end portion of the handle 640, a second sleeve 620 formed in a proximal end portion of the handle 640, and a thumbwheel 742 disposed under the guidewire 102 between the first sleeve 610 and the second sleeve 620.

[0073] The thumb wheel 742 is mounted on an axle connected to each side of the handle 640. The thumb wheel 742 is configured to assist in feeding the guidewire 102 distally out of the guidewire management device 600 by means of the first sleeve 610. The thumb wheel 742 is also configured to assist in feeding the guidewire 102 proximally into the guidewire management device 600 by means of the first sleeve 610.

[0074] A method for feeding or advancing the guidewire 102 distally out of the guidewire management device 600 is presented below. A method for feeding or retracting the guidewire 102 distally into the guidewire management device 600 is also presented below.

[0075] Method

[0076] The method of the guidewire management device 100, 300, or 600 includes a connecting step of connecting the first sleeve 110 or 610 of the guidewire management device 100, 300, or 600 to a hub of a medical device (e.g., a hollow needle) inserted into an insertion site of a patient.

[0077] 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. As the guidewire 102 is advanced through the hub of the medical device and into the insertion site of the patient, the seal (e.g., the 'O' ring 114 or 714) in the first sleeve 110 or 610 blocks fluid (e.g., air) from escaping the guidewire management device 100, 300, or 600.

[0078] The advancing step can include squeezing the guidewire 102 within the sterile barrier 104 and pushing the guidewire 102 into the first sleeve 110 by hand. The advancing can instead include pressing the guidewire 102 within the sterile barrier 104 against the thumb wheel 742 and rolling the thumb wheel 742 to push the guidewire 102 into the first sleeve 610.

[0079] In practice, the guidewire 102 can be pushed into the first sleeve 110 or 610 and out of the guidewire management device 100 or 600 by squeezing the combination of guidewires 102 within the pouch 105 or pressing the guidewire 102 within the pouch 105 against the thumb wheel 742, pushing the guidewire 102 into the first sleeve 110 by hand or by rolling the thumb wheel 742, releasing the combination of guidewires 102 within the pouch 105, and repeating the foregoing as necessary. The guidewire 102 can be pushed into the first sleeve 110 and out of the guidewire management device 300 by squeezing the combination of guidewires 102 within the tube cover 305, pushing the guidewire 102 into the first sleeve 110 by hand, releasing the combination of guidewires 102 within the tube cover 305, and repeating the foregoing as necessary.

[0080] The method can further include a step of aborting the pushing of the guidewire 102 into the insertion site of the patient when the ball end of the guidewire 102 is captured in the constriction 124 of the hole 122 in the second sleeve 120 of the guidewire management device 100 or 300. Likewise, the step of aborting can include aborting the pushing of the guidewire 102 into the insertion site of the patient when the ball end of the guidewire 102 is captured in the recess 724 in the second sleeve 620 of the guidewire management device 600.

[0081] The method further includes withdrawing the guidewire 102 from the insertion site of the patient through the hub of the medical device and into the first sleeve 110 or 610. The seal (e.g., the 'O' ring 114 or 714) in the first sleeve 110 or 610 blocks fluid (e.g., blood) from entering the guidewire management device 100, 300, or 600 when the guidewire 102 is withdrawn from the insertion site.

[0082] In practice, the guidewire 102 can be withdrawn through the first sleeve 110 or 610 into the guidewire management device 100 or 600 by squeezing the combination of the guidewire 102 within the pocket 105 or pressing the guidewire 102 within the pocket 105 against the thumbwheel 742, withdrawing the guidewire 102 from the first sleeve 110 with the hand or by rolling the thumbwheel 742, releasing the combination of the guidewire 102 within the pocket 105, and repeating the foregoing as necessary. The guidewire 102 can be withdrawn through the first sleeve 110 into the guidewire management device 300 by squeezing the combination of the guidewire 102 within the tube 305, withdrawing the guidewire 102 from the first sleeve 110 with the hand, releasing the combination of the guidewire 102 within the tube 305, and repeating the foregoing as necessary.

[0083] The method can further include a step of aborting the withdrawing of the guidewire 102 from the insertion site of the patient when the proximal end or the ball end of the guidewire 102 abuts the plug 145 in the proximal portion of the guidewire conduit 144 of the guidewire management device 100 or 300.

[0084] While certain specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in some detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications of these specific embodiments can occur to persons skilled in the art. Therefore, it is intended that the scope of the concepts provided herein encompass those additional adaptations and / or modifications. Accordingly, while the specific embodiments have been disclosed, this has been done by way of example only, and without limitation, and various changes and modifications within the scope of the concepts provided herein will become apparent to those skilled in the art.

Claims

1. A guidewire management device comprising: a guidewire; a first hub configured to feed the guidewire distally out of the guidewire management device or to withdraw the guidewire proximally into the guidewire management device; a second hub proximal of the first hub, the second hub configured to feed the guidewire in unison with the first hub, wherein at least a length of the guidewire extending between the first hub and the second hub is disposed within a sterile barrier configured to maintain sterility of the guidewire; a frame comprising a pair of tubular rails; and a guidewire conduit passing through the tubular rails, the guidewire conduit comprising the guidewire disposed therein; wherein the first hub is mounted between each of the pair of tubular rails, and the second hub is mounted between each of the pair of tubular rails.

2. The guidewire management device of claim 1, wherein the first hub has a distal portion configured as a male connector having a luer fitting for connecting the first hub to a complementary female connector.

3. The guidewire management device of claim 1 or 2, wherein the first hub is configured to straighten the guidewire as the guidewire is withdrawn proximally into the guidewire management device.

4. The guidewire management device of claim 1, wherein the first hub comprises a seal configured to block fluid from entering or escaping the guidewire management device as the guidewire is withdrawn proximally into the guidewire management device.

5. The guidewire management device of claim 1, wherein the first hub has a proximal portion comprising an aperture configured to receive a distal portion of the sterile barrier.

6. The guidewire management device of claim 1, wherein the second hub has a distal portion comprising an aperture configured to receive a proximal portion of the sterile barrier.

7. The guidewire management device of claim 1, wherein the second hub has a proximal portion comprising another aperture configured to stop an end of the guidewire from passing completely through the second hub.

8. The guidewire management device of claim 1, wherein the guidewire has a distal portion comprising a 'J' tip configured to straighten as a tip of the guidewire enters the first hub as the guidewire is withdrawn proximally into the guidewire management device.

9. The guidewire management device of claim 1, wherein the guidewire has a proximal portion comprising a ball tip configured to stop the guidewire from passing completely through the second hub.

10. The guidewire management device of claim 1, wherein the sterile barrier is a pleated bag configured to unpleat as it is pulled from the second hub while the guidewire is being fed distally out of the guidewire management device and to pleat as it is inserted into the first hub.

11. The guidewire management device of claim 1, wherein the sterile barrier is a bellows cover configured to stretch from an equilibrium state and relax back to the equilibrium state while feeding the guidewire distally out of the guidewire management device.

12. The guidewire management device of any one of claims 8-11, wherein the first sleeve has a distal end portion configured as a male connector having a luer fitting for connecting the first sleeve to a complementary female connector.

13. The guidewire management device of any one of claims 8-11, wherein the first sleeve is configured to straighten a tip of the guidewire as the tip enters the first sleeve when the guidewire is being withdrawn proximally into the guidewire management device.

14. The guidewire management device of any one of claims 8-11, wherein the second sleeve has a proximal end portion comprising a bore having a constriction configured to capture a ball tip of the guidewire and prevent the guidewire from passing completely through the second sleeve.

15. The guidewire management device of claim 8, wherein the guidewire conduit has a proximal end portion comprising a plug configured to prevent a ball tip of the guidewire from passing through an opening in a proximal end of the guidewire conduit, thereby preventing the tip of the guidewire from passing completely through the first sleeve and reforming the 'J' tip when the guidewire is being withdrawn proximally into the guidewire management device.

16. The guidewire management device of any one of claims 8-11, wherein the sterile barrier is a pleated bag configured to unpleat as it is pulled out of a bore in a distal end portion of the second sleeve and to pleat as it is inserted into a bore in a proximal end portion of the first sleeve while feeding the guidewire distally out of the guidewire management device.

17. The guidewire management device of any one of claims 8-11, wherein the sterile barrier is a bellows cover configured to stretch from an equilibrium state and relax back to the equilibrium state while feeding the guidewire distally out of the guidewire management device.

18. The guidewire management device of claim 1, comprising: a handle; the guidewire comprising a 'J' tip in a distal end portion of the guidewire; the first sleeve formed in a distal end portion of the handle; the second sleeve formed in a proximal end portion of the handle; and a thumbwheel disposed under the guidewire between the first sleeve and the second sleeve, the thumbwheel configured to assist in feeding the guidewire distally out of the guidewire management device by means of the first sleeve or withdrawing the guidewire proximally into the guidewire management device by means of the first sleeve.

19. The guidewire management device of claim 18, wherein the first sleeve has a distal end portion configured as a male connector having a luer fitting for connecting the first sleeve to a complementary female connector. ​ 20. The guidewire management device of claim 18 or 19, wherein the first sleeve is configured to straighten the 'J' shaped tip of the guidewire as the tip of the guidewire enters the first sleeve when the guidewire is being proximally withdrawn into the guidewire management device.

21. The guidewire management device of claim 18, wherein the second sleeve has a proximal end portion comprising a bore having a constriction configured to capture a ball tip of the guidewire and prevent the guidewire from passing completely through the second sleeve.

22. The guidewire management device of claim 18, wherein the sterile barrier is a pleated pocket on the entire guidewire except within or distal of the first sleeve, the pleated pocket configured to be pleated as the pocket is inserted into a bore in a proximal end portion of the first sleeve while the guidewire is being fed distally out of the guidewire management device.

23. The guidewire management device of claim 22, wherein a proximal end of the pocket is closed, providing a proximal limit on withdrawal of the guidewire into the guidewire management device by means of the first sleeve, the proximal limit established by the proximal end of the pocket configured to prevent the 'J' shaped tip of the guidewire from passing completely through the first sleeve when the guidewire is being proximally withdrawn into the guidewire management device by means of the first sleeve.

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