Guidewire management device and method thereof

Abstract

Guidewire management devices 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.

Description

[0001] priority

[0002] This application claims the priority benefit of U.S. Patent Application No. 62 / 989,371, filed March 13, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to guidewire management devices and methods thereof. Background Technology

[0004] The Seldinger technique is typically used to place a catheter in a patient's blood vessel. This technique involves inserting a hollow needle into the vessel, inserting a guidewire into the needle, advancing the guidewire into the vessel, and removing the needle from the vessel while leaving the guidewire in place. The catheter is then advanced over the guidewire until it is properly positioned within the patient's vascular system. The guidewire is then removed from the patient.

[0005] Guidewires used in the Seldinger technique are typically packaged in coiled-tube dispensers to maintain sterility and facilitate manipulation. 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 the connector (configured to guide the guidewire into the needle), while the other hand grasps the guidewire and guides it from the dispenser into the needle. The more the guidewire is manipulated, the greater the likelihood of contamination or damage. Given these considerations, better guidewire management is needed in medical procedures, such as those requiring the Seldinger technique.

[0006] This article discloses a guidewire management device and method for solving the above problems. Summary of the Invention

[0007] This document discloses a guidewire management device, which in some embodiments includes a guidewire, a first sleeve, and a second sleeve. The first sleeve is configured to feed the guidewire distally away from the guidewire management device. The first sleeve is also configured to feed the guidewire proximally into the guidewire management device. The second sleeve is located proximal to the first sleeve in the guidewire management device. The second sleeve is configured to feed the guidewire concurrently with the first sleeve. At least a portion of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain the sterility of the guidewire. The sterile barrier is a separable cannula configured to detach from the guidewire while simultaneously feeding the guidewire distally away from the guidewire management device.

[0008] In some embodiments, the first sleeve has a distal portion configured as a convex connector with a Luer taper for connecting the first sleeve to a complementary concave connector.

[0009] In some implementations, the first sleeve is configured to straighten the guidewire when the guidewire is fed proximally into the guidewire management device.

[0010] In some embodiments, the first sleeve includes a seal configured to prevent fluid from entering or escaping the guidewire management device when the guidewire is fed proximally into the guidewire management device.

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

[0012] In some embodiments, the second sleeve has a distal portion that includes an aperture configured to receive a proximal portion of a sterile barrier.

[0013] In some embodiments, the second sleeve has a proximal portion that includes another hole configured to prevent one end of the guidewire from passing completely through the second sleeve.

[0014] In some embodiments, the guidewire has a distal portion including a 'J'-shaped tip configured to straighten the tip of the guidewire as it enters the first sleeve when the guidewire is fed proximally into the guidewire management device.

[0015] In some implementations, the guidewire has a proximal portion that includes a ball end configured to prevent the guidewire from passing completely through the second sleeve.

[0016] In some implementations, the guidewire management device is configured to rearrange the separable sleeve above the guidewire while feeding the guidewire proximally into the guidewire management device.

[0017] This document also discloses a guidewire management device, which in some embodiments includes a handle, a guidewire, a first sleeve formed in a distal portion of the handle, a second sleeve formed in a proximal portion of the handle, and a thumb wheel disposed below the guidewire between the first and second sleeves. At least a length of the guidewire extending between the first and second sleeves is disposed within a sterile barrier configured to maintain the sterility of the guidewire. The sterile barrier is a separable cannula configured to separate from the guidewire while simultaneously feeding the guidewire distally away from the guidewire management device. The thumb wheel is configured to assist in feeding the guidewire distally away from the guidewire management device by means of the first sleeve. The thumb wheel is also configured to assist in feeding the guidewire proximally into the guidewire management device by means of the first sleeve.

[0018] In some embodiments, the first sleeve has a distal portion configured as a convex connector with a Luer joint for connecting the first sleeve to a complementary concave connector.

[0019] In some implementations, the first sleeve is configured to straighten the 'J'-shaped tip in the distal portion of the guidewire as the tip of the guidewire enters the first sleeve when the guidewire is fed proximally into the guidewire management device.

[0020] In some embodiments, the second sleeve has a proximal portion that includes an orifice with a constriction portion configured to capture the ball end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

[0021] In some implementations, the separable sleeve is located over the entire guidewire except inside or on the distal side of the first sleeve.

[0022] In some embodiments, the guidewire management device further includes: a guidewire conduit coupled to a second sleeve; and a cannula conduit coupled to both a first dissociative sleeve in a distal portion of the handle and a second dissociative sleeve in a proximal portion of the handle. The guidewire conduit is configured to feed the guidewire distally into the second sleeve. The cannula conduit is configured to collect a separable cannula therein, which dissociates from the guidewire as the guidewire is fed distally away from the guidewire management device.

[0023] In some implementations, the handle includes a channel configured to retain the guidewire catheter therein when the guidewire catheter is in a coiled configuration.

[0024] In some embodiments, the guidewire management device further includes a guidewire-cannula conduit connected to both a second sleeve and a first dissociative sleeve in the distal portion of the handle. The guidewire-cannula conduit is configured to feed the guidewire distally into the second sleeve. The guidewire-cannula conduit is also configured to collect a separable cannula therein by means of the first dissociative sleeve, which dissociates from the guidewire as the guidewire is fed distally away from the guidewire management device.

[0025] In some implementations, the distal end of the separable cannula that separates the guidewire is configured to chase the proximal end of the guidewire near the guidewire-cannula while the guidewire is being fed distally away from the guidewire management device.

[0026] In some implementations, the handle includes a channel configured to retain the guidewire-cannula in which the guidewire-cannula is in a coiled configuration.

[0027] In some embodiments, the guidewire management device also includes a flexible diaphragm extending from the distal portion of the handle to the proximal portion of the handle above the thumbwheel. The flexible diaphragm is configured to press down on the thumbwheel for feeding the guidewire distally out of the guidewire management device or proximally into the guidewire management device.

[0028] These and other features of the concepts provided herein will become more apparent to those skilled in the art from the accompanying drawings and the following description, which illustrate specific embodiments of these concepts in more detail. Furthermore, this application relates to U.S. Patent Application No. 17 / 079,320, filed October 23, 2020, which is incorporated herein by reference in its entirety. Attached Figure Description

[0029] Figure 1 An isometric view of a first guidewire management device according to some implementation schemes is provided.

[0030] Figure 2 A longitudinal section of a first guidewire management device according to some implementation schemes is provided.

[0031] Figure 3 An isometric view of a second guidewire management device according to some implementation schemes is provided.

[0032] Figure 4 A longitudinal section of a second guidewire management device according to some implementation schemes is provided.

[0033] Figure 5 Detailed views of the ball end of the guidewire distal to the plug in the guidewire catheter are provided according to some embodiments.

[0034] Figure 6 A side view of a third guidewire management device according to some implementation schemes is provided.

[0035] Figure 7 An isometric view of the handle of a fourth guidewire management device according to some embodiments is provided.

[0036] Figure 8 A longitudinal section of a fourth guidewire management device according to some implementation schemes is provided.

[0037] Figure 9 A side view of the handle of a fifth guidewire management device according to some embodiments is provided.

[0038] Figure 10 A handle for a fifth guidewire management device is provided according to some embodiments, wherein the guidewire is partially advanced away from the guidewire management device.

[0039] Figure 11A handle for the fifth guidewire management device is provided, wherein the guidewire is positioned relative to... Figure 10 The further distance shown partially propels the wire away from the guidewire management device.

[0040] Figure 12 A side view of the handle of a sixth guidewire management device according to some implementation schemes is provided.

[0041] Figure 13 An isometric view of a seventh guidewire management device according to some implementation schemes is provided.

[0042] Figure 14 A side view of a seventh guidewire management device according to some implementation schemes is provided.

[0043] Figure 15 An isometric view of an eighth guidewire management device according to some implementation schemes is provided.

[0044] Figure 16 A side view of an eighth guidewire management device according to some implementation schemes is provided.

[0045] Figure 17 A side view of an eighth guidewire management device coupled to a catheter assembly is provided according to some implementation schemes. Detailed Implementation

[0046] 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 provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may optionally be combined with or substituted for any of the many other embodiments disclosed herein.

[0047] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that they 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 different features or steps within a set of features or steps, and do not provide for a series or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in sequence, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as “left,” “right,” “up,” “down,” “front,” and “back” are for convenience and do not imply any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0048] For example, the terms "proximal," "proximal portion," or "proximal portion" of a catheter disclosed herein include a portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Similarly, the term "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the term "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when the catheter is used on a patient. A proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise requires, a proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0049] For example, the terms "distal," "distal portion," or "distal part" as used with respect to the catheter disclosed herein include the portion of the catheter intended to be close to or in the patient when the catheter is used on a patient. Similarly, the term "distal length" of the catheter includes the length of the catheter intended to be close to or in the patient when the catheter is used on a patient. For example, the term "distal end" of the catheter includes the end of the catheter intended to be close to or in the patient when the catheter is used on a patient. The distal, distal portion, or distal length of the catheter may include the distal end of the catheter; however, the distal, distal portion, or distal length of the 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 the catheter is not the distal portion or distal length of the catheter.

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

[0051] As mentioned above, better guidewire management is needed in medical procedures, such as those requiring the Serdinger technique. This paper discloses a guidewire management device and method that address the aforementioned problems.

[0052] Guide wire management device

[0053] Figures 1 to 16Various guidewire management devices, namely guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500, are illustrated. For ease of explanation, guidewire management devices 100, 300, 600, and 700 are described first, focusing on features common to each other and many other guidewire management devices described herein. Such features can be identified in the various guidewire management devices by the same reference numerals (e.g., guidewire 102), similar reference numerals (e.g., first sleeve 110, first sleeve 610, first sleeve 710, etc., wherein the preceding numerals of the reference numerals are different to reflect the feature or the embodiment associated with the feature), descriptions, or combinations thereof. In fact, common features in any group of guidewire management devices of the various guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500 can be similarly identified. Following the initial description of the guidewire management devices 100, 300, 600, and 700, the following descriptions, individually or collectively, describe some unique features of the guidewire management devices 100, 300, 600, 700, 900, 1200, 1300, and 1500.

[0054] As shown in the figure, the guide wire management device 100, 300, 600 or 700 includes a guide wire 102, a first sleeve 110, 610 or 710 and a second sleeve 120, 620 or 720.

[0055] The first sleeve 110, 610, or 710 is configured with an inner cavity for distally feeding or distally advancing the guidewire 102 away from or from the guidewire management device 100, 300, 600, or 700. The first sleeve 110, 610, or 710 has a distal portion configured as a convex connector with a Luer joint for connecting the first sleeve 110, 610, or 710 to a complementary concave connector, such as a bushing of a hollow needle or a concave connector of a catheter. The convex connector is configured such that when coupled to such a complementary concave connector, such as the aforementioned catheter, the guidewire management device 100, 300, 600, or 700 forms a single unit with the catheter, thereby enabling guidewire management (e.g., distally feeding the guidewire 102 away from the guidewire management device 100, 300, 600, or 700 into the catheter) using one hand (see...). Figure 17 The first sleeve 110, 610, or 710 also has a proximal portion including a hole 112, 612 (not shown), or 712, the inner cavity of the first sleeve 110, 610, or 710 leading to the hole. The hole 112, 612, or 712 is configured to receive or collect the distal portion of the sterile barrier 104 or 304 when the guidewire 102 is fed distally away from the guidewire management device 100, 300, 600, or 700.

[0056] The first sleeve 110, 610, or 710 is also configured to feed or retract the guidewire 102 proximally into or out of the guidewire management device 100, 300, 600, or 700. The first sleeve 110, 610, or 710 is configured to straighten the guidewire 102, for example, its 'J'-shaped tip (see [reference]) when the guidewire 102 is fed proximally into the guidewire management device 100, 300, 600, or 700. Figure 7 and 8 According to some embodiments, the guidewire 102 has a 'J'-shaped tip. The first sleeve 110, 610, or 710 may include a seal, such as an 'O'-ring 114, 614 (not shown), or 714, configured to prevent fluid (e.g., blood) from entering the guidewire management device 100, 300, 600, or 700 when the guidewire is fed proximally into the guidewire management device 100, 300, 600, or 700. The seal (e.g., 'O'-ring 114, 614, or 714) is also configured to prevent fluid (e.g., air) from escaping the guidewire management device 100, 300, 600, or 700 when the guidewire is fed proximally into the guidewire management device 100, 300, 600, or 700, thereby minimizing or eliminating the risk of air embolism.

[0057] The second sleeve 120, 620, or 720 is proximal to the first sleeve 110, 610, or 710 in the guidewire management device 100, 300, 600, or 700, such that at least a portion of the length of the guidewire 102 extends between the first sleeve 110, 610, or 710 and the second sleeve 120, 620, or 720. At least a portion of the guidewire 102 extending between the first sleeve 110, 610, or 710 and the second sleeve 120, 620, or 720 is disposed within a sterile barrier 104 or 304.

[0058] The second sleeve 120, 620, or 720 is configured with an inner cavity for feeding the guide wire 102 in accordance with the first sleeve 110, 610, or 710 (e.g., feeding the guide wire 102 distally away from the guide wire management device 100, 300, 600, or 700). The second sleeve 120, 620, or 720 has a proximal portion optionally including a hole 122, and the inner cavity of the second sleeve 120, 620, or 720 opens into the hole. For example, the second sleeve 120 has a proximal portion including the hole 122, while the second sleeve 620 or 720 has a proximal portion without such a hole. Regardless of whether the second sleeve 120, 620, or 720 includes such an aperture, the second sleeve 120, 620, or 720 further includes a constriction portion 124, a recess 724, or a similar stop for preventing the end of the guidewire 102 (such as its ball end or block end) from completely passing through the second sleeve 120, 620, or 720 when the guidewire 102 is fed distally away from the guidewire management device 100, 300, 600, or 700. Because the constriction portion 124, the recess 724, or the similar stop is configured to prevent the end of the guidewire 102 from completely passing through the second sleeve 120, 620, or 720, and is also configured to prevent the guidewire from completely passing through the guidewire management device 100, 300, 600, or 700 and entering the patient, the guidewire 102 may be lost in this situation.

[0059] The second sleeve 120, 620, or 720 is also configured to feed the guidewire 102 proximally into the guidewire management device 100, 300, 600, or 700 in accordance with the first sleeve 110, 610, or 710. The second sleeve 120, 620, or 720 has a distal portion including an aperture 126, 626 (not shown), or 726, the inner cavity of which leads to the aperture. The aperture 126, 626, or 726 is configured to receive or collect a proximal portion of the sterile barrier 104 or 304 when the guidewire 102 is proximally fed into the guidewire management device 100, 300, 600, or 700.

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

[0061] The distal portion of guidewire 102 may include a 'J'-shaped tip configured to straighten as the tip of guidewire 102 enters a first sleeve 110, 610, or 710 when the guidewire 102 is fed proximally into guidewire management devices 100, 300, 600, or 700. When the guidewire 102 is fed distally away from guidewire management devices 100, 300, 600, or 700, the 'J'-shaped tip is configured to reform into a 'J' shape upon release from its constriction (e.g., the first sleeve 110, 610, or 710). If the first sleeve 110, 610, or 710 is connected to a complementary concave connector, such as a concave connector for a hollow needle bushing, the tip of guidewire 102 does not reform into a 'J' shape until the tip extends distally beyond the needle (e.g., within a blood vessel).

[0062] The proximal portion of the guidewire 102 may include a ball end configured to prevent the guidewire 102 from passing completely through the second sleeve 120, 620, or 720 when the guidewire 102 is fed distally away from the guidewire management device 100, 300, 600, or 700, based on the constriction portion 124, the recess 724, or a similar stop.

[0063] A sterile barrier 104 or 304 is configured to maintain the sterility of the guidewire 102 while it is placed therein. Importantly, the guidewire never needs to be touched by the clinician during the procedure, thus maintaining the sterility of the guidewire 102 and ensuring that the clinician remains free from contact with bodily fluids.

[0064] The sterile barrier 104 is a pleated bag. The sterile barrier 104 or bag 104 is configured not to pleat when the guidewire 102 is pulled out of or through the second sleeve 620 or 720 of the guidewire management device 600 or 700 while being fed distally away from the guidewire management device 100, 600, or 700. The bag 104 is also configured to pleat when the guidewire 102 is inserted into the first sleeve 110, 610, or 710 while being fed distally away from the guidewire management device 100, 600, or 700. Similarly, the bag 104 is configured not to pleat when the guidewire 102 is pulled out of the first sleeve 110, 610, or 710 while being fed proximally into the guidewire management device 100, 600, or 700. The bag 104 is also configured to pleat when the guide wire 102 is fed proximally into the guide wire management device 100, 600 or 700, and when the second sleeve 120 of the guide wire management device 100 is inserted or the second sleeve 620 or 720 of the guide wire management device 600 or 700 is passed through.

[0065] Advantageously, in guide wire management devices such as guide wire management devices 600 and 700, the combination of the length of the bag 104 and its sealing or valve end is configured to prevent the end of the guide wire 102 (e.g., the ball end) from passing through an opening that would otherwise be in the proximal end of the bag 104. When the guide wire 102 is fed proximally into the guide wire management device 600 or 700, preventing the end of the guide wire 102 from passing through this opening prevents the tip of the guide wire 102 from passing completely through the first sleeve 110 and reforming the 'J'-shaped tip.

[0066] A method for feeding or advancing guidewire 102 distally away from guidewire management device 100, 600 or 700 is provided below. A method for feeding or withdrawing guidewire 102 distally into or out of guidewire management device 100, 600 or 700 is also provided below.

[0067] The sterile barrier 304 is a bellowed boot. The sterile barrier 304 or boot 304 is configured to repeatedly extend and relax back to a balanced state while feeding the guidewire 102 distally away from the guidewire management device 300. Similarly, the boot 304 is configured to repeatedly extend and relax back to a balanced state while feeding the guidewire 102 proximally into the guidewire management device 300.

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

[0069] Although not shown for any of the guidewire management devices in guidewire management devices 100, 300, 600, and 700, the sterile barrier 104 or 304 may alternatively be a separable cannula 904 over the entire guidewire 102, or at least a majority of the guidewire 102, except within or distal to the first sleeve 110, 610, or 710. The separable cannula 904 is configured to separate from the guidewire 102 while feeding it distally away from the guidewire management device (e.g., see guidewire management devices 900, 1200, 1300, and 1500). Some of the aforementioned guidewire management devices (e.g., guidewire management devices 1300 and 1500) are configured to insert the guidewire 102 into the separable cannula 904 while feeding it proximally into the guidewire management device. The separable cannula 904 may include graduations configured to indicate the length of the guidewire 102 from its tip.

[0070] See Figures 1 to 4To describe at least some unique features of 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 guide rails 142; a guidewire conduit 150 passing through the pair of tubular guide rails 142; a first sleeve 110 mounted on a post between each of the pair of tubular guide rails 142 and mounted on a post between each of the pair of tubular guide rails 142; and a second sleeve 120 mounted proximal to the first sleeve 110 on a post between each of the pair of tubular guide rails 142. At least a portion of the guidewire 102 is disposed within the guidewire conduit 150.

[0071] Depending on the polymer material chosen, the guidewire conduit 150 can be opaque or translucent. When the guidewire conduit 150 is translucent, it is configured to allow observation of the guidewire 102 while it is being fed distally out of the guidewire management device 100 or 300 or proximally into the guidewire management device 100 or 300.

[0072] Figure 5 The ball end of the guidewire 102 distal to the plug 152 in the guidewire catheter 150 is shown according to some embodiments.

[0073] The guidewire catheter 150 has a proximal portion including a plug 152 configured to prevent the ball end of the guidewire 102 from passing through an opening that would otherwise be in the proximal end of the guidewire catheter 150. Alternatively, the plug 152 is simply a crimped portion of the guidewire catheter 150 having the same effect. When the guidewire 102 is fed proximally into the guidewire management device 100 or 300, preventing the ball end of the guidewire 102 from passing through this opening prevents the tip of the guidewire 102 from passing completely through the first sleeve 110 and reforming the 'J'-shaped tip.

[0074] Turning Figures 6 to 16To describe at least some unique features of guidewire management devices 600, 700, 900, 1200, 1300, and 1500, the guidewire management devices 600, 700, 900, 1200, 1300, or 1500 include: a handle 640, 740, 940, 1240, 1340, or 1540; a guidewire 102; and a first sleeve 610, 710, 910, 1210, 1310, or 1510, which is located in the distal portion of the handle 640, 740, 940, 1240, 1340, or 1540. Formed; a second sleeve 620, 720, 920, 1220, 1320 or 1520, which is formed in the proximal portion of the handle 640, 740, 940, 1240, 1340 or 1540; and a thumbwheel 642, 742, 942, 1242, 1342 or 1542, which is arranged below the guide wire 102 between the first sleeve 610, 710, 910, 1210, 1310 or 1510 and the second sleeve 620, 720, 920, 1220, 1320 or 1520.

[0075] Handles 640, 740, 940, 1240, 1340, or 1540 are dexterous because they are configured to be held in the right or left hand of the clinician. Furthermore, handles 640, 740, 940, 1240, 1340, or 1540 are configured to be held in at least two different modes. The first mode (where the clinician holds handle 640, 740, 940, 1240, 1340, or 1540 like a person holding the handle of a hammer) is the general mode for manipulating guidewire management devices 600, 700, 900, 1200, 1300, or 1500. The second mode (where the clinician places his or her thumb back on the thumb wheel 642, 742, 942, 1242, 1342, or 1542) is the mode of operation used to advance guidewire 102 away from guidewire management device 600, 700, 900, 1200, 1300, or 1500, or to withdraw guidewire 102 from guidewire management device 600, 700, 900, 1200, 1300, or 1500. Despite the above, some clinicians may find it comfortable to hold the handle 640, 740, 940, 1240, 1340, or 1540 as if holding a flashlight, thus requiring less hand movement to enter both the first and second modes.

[0076] Handles 640, 1340, or 1540 include channels 641, 1341, or 1541 configured to retain a catheter therein. As described below, the catheter may be a guidewire conduit 1350 of the guidewire management device 1300, a guidewire sheath conduit 1550 of the guidewire management device 1500, etc. Advantageously, such channels can retain the catheter in a coiled configuration, thereby filling a compact space with an elongated catheter. Although only handles 640, 1340, and 1540 with channels are shown, any handle of handles 740, 940, and 1240 may include channels configured to retain a catheter. Additionally, handles 640, 1340, or 1540 need not include channels 641, 1341, or 1541.

[0077] Although there may be differences in one or more design elements, the first sleeves 910, 1210, 1310, or 1510 are similar to the first sleeves 110, 610, or 710 described above. Thus, the descriptions of the first sleeves 110, 610, and 710 described above should be understood to be extended to the first sleeves 910, 1210, 1310, and 1510 as if the first sleeves 910, 1210, 1310, and 1510 were included in the descriptions of the first sleeves 110, 610, and 710.

[0078] Although there may be differences in one or more design elements, the second sleeves 920, 1220, 1320, or 1520 are similar to the second sleeves 120, 620, or 720 described above. Thus, the descriptions of the second sleeves 120, 620, and 720 above should be understood as extending to the second sleeves 920, 1220, 1320, and 1520, as if the descriptions of the second sleeves 120, 620, and 720 included the second sleeves 920, 1220, 1320, and 1520.

[0079] Thumb wheels 642, 742, 942, 1242, 1342, or 1542 can be rotatably mounted on a shaft (which is fixedly connected to each side of a handle 640, 740, 940, 1240, 1340, or 1540) such that thumb wheels 642, 742, 942, 1242, 1342, or 1542 rotate relative to both the shaft and the handle 640, 740, 940, 1240, 1340, or 1540. Alternatively, thumbwheels 642, 742, 942, 1242, 1342, or 1542 may include a shaft (e.g., as an integral part) or be fixedly mounted on a shaft, which is in turn rotatably coupled to each side of handles 640, 740, 940, 1240, 1340, or 1540, such that the combination of thumbwheels 642, 742, 942, 1242, 1342, or 1542 and the shaft rotates relative to handles 640, 740, 940, 1240, 1340, or 1540. Thumb rollers 642, 742, 942, 1242, 1342, or 1542 are configured to assist in feeding the guidewire 102 distally away from the guidewire management device 600, 700, 900, 1200, 1300, or 1500 by means of a first sleeve 610, 710, 910, 1210, 1310, or 1510. Thumb rollers 642, 742, 942, 1242, 1342, or 1542 are also configured to assist in feeding the guidewire 102 proximally into the guidewire management device 600, 700, 900, 1200, 1300, or 1500 by means of a first sleeve 610, 710, 910, 1210, 1310, or 1510.

[0080] A method for feeding or advancing guidewire 102 distally away from guidewire management device 600, 700, 900, 1200, 1300, or 1500 is provided below. A method for feeding or withdrawing guidewire 102 distally into or out of guidewire management device 600, 700, 900, 1200, 1300, or 1500 is also provided below.

[0081] Turning Figures 9 to 12 To describe at least some unique features of the guidewire management device 900 or 1200, the guidewire management device 900 or 1200 includes a first separation sleeve 911 or 1211 in the distal portion of the handle 940 or 1240.

[0082] The first separating sleeve 911 or 1211 is separated from the first sleeve 910 or 1210 in the distal portion of the handle 940 or 1240. As described above regarding the cavities of the first sleeves 110, 610, or 710 and by extension, the cavities of the first sleeves 910 or 1210, the first separating sleeve 911 or 1211 is configured with an inner cavity. In effect, the inner cavity of the first separating sleeve 911 or 1211 separates from or branches from the inner cavity of the first sleeve 910 or 1210, thereby forming a branched inner cavity in the distal portion of the handle 940 or 1240 between the first sleeve 910 or 1210 and the first separating sleeve 911 or 1211. The first sleeve 910 or 1210 is configured to feed the guidewire 102 at least distally away from the guidewire management device 900 or 1200, while the first separation sleeve 911 or 1211 is configured to remove the separable sleeve 904, which separates from the guidewire 102 while feeding the guidewire 102 distally away from the guidewire management device 900 or 1200. In practice, the bifurcated cavity between the first sleeve 910 or 1210 and the first separation sleeve 911 or 1211 is configured to facilitate the separation of the separable sleeve 904 from the guidewire 102 while feeding the guidewire 102 distally away from the guidewire management device 900 or 1200.

[0083] Turn Figure 12 To describe at least some unique features of the guidewire management device 1200, the guidewire management device 1200 includes a flexible membrane 1206 extending from the distal portion of the guidewire management device 1200 above the thumbwheel 1242 to the proximal portion of the guidewire management device 1200. In practice, the membrane 1206 may be coupled to a portion of a first sleeve 1210 in the distal portion of the guidewire management device 1200 and a portion of a second sleeve 1220 in the proximal portion of the guidewire management device 1200.

[0084] Membrane 1206 is configured to feed guidewire 102 distally out of guidewire management device 1200 or proximally into guidewire management device 1200. Membrane 1206 is flexible enough that its central portion presses down on the proximal portion of thumbwheel 1242, moves distally as thumbwheel 1242 rolls, and releases back to equilibrium for one or more additional rounds of the foregoing. Similarly, membrane 1206 is flexible enough that its central portion presses down on the distal portion of thumbwheel 1242, moves proximally as thumbwheel 1242 rolls, and releases back to equilibrium for one or more additional rounds of the foregoing.

[0085] The membrane 1206 may have low hardness and a certain degree of adhesion to facilitate clamping the guidewire 102 or a combination of guidewires 102 within the bag 104 or the separable sleeve 904, for feeding the guidewire 102 distally out of the guidewire management device 1200 or proximally into the guidewire management device 1200. For example... Figure 12 As shown, for example, the assembly of guidewires 102 within the separable sleeve 904 is arranged between the membrane 1206 and the thumbwheel 1242 of the guidewire management device 1200. When the middle portion of the membrane 1206 is pressed down onto the proximal or distal portion of the thumbwheel 1242, the assembly of guidewires 102 within the separable sleeve 904 is also pressed down onto the proximal or distal portion of the thumbwheel 1242. As the thumbwheel 1242 subsequently rolls, the assembly of guidewires 102 within the separable sleeve 904 moves distally or proximally together with the middle portion of the membrane 1206. And when the middle portion of the membrane 1206 is released back to the equilibrium state of the membrane 1206, the assembly of guidewires 102 within the separable sleeve 904 is also released. Thus, in one or more of the aforementioned processes, the guidewire 102 can be fed distally away from the guidewire management device 1200 or proximally into the guidewire management device 1200.

[0086] Turning Figure 13 and 14 To describe at least some unique features of the guidewire management device 1300, the guidewire management device 1300 also includes: a guidewire conduit 1350 connected to a second sleeve 1320; and a cannula conduit 1354 connected to both a first separation sleeve 1311 in the distal portion of the handle 1340 and a second separation sleeve 1321 in the proximal portion of the handle 1340.

[0087] Although there may be differences in one or more design elements, the first separating sleeve 1311 is similar to the first separating sleeve 911 or 1211 described above. Thus, the descriptions of the first separating sleeves 911 and 1211 described above should be understood to extend to the first separating sleeve 1311 as if the first separating sleeve 1311 were included in the description of the first separating sleeves 911 or 1211.

[0088] The second separating sleeve 1321 is separated from the second sleeve 1320 in the distal portion of the handle 1340. As described above regarding the lumens of the second sleeves 120, 620, or 720, and by extension, the lumens of the second sleeve 1320, the second separating sleeve 1321 is configured with an inner cavity. In effect, the inner cavity of the second separating sleeve 1321 separates from or branches from the inner cavity of the second sleeve 1320, thereby forming a bifurcated inner cavity between the second sleeve 1320 and the second separating sleeve 1321 in the distal portion of the handle 1340. Similar to the channel 1341 of the handle 1340 (which is configured to retain the guidewire conduit 1350 therein), the second separating sleeve 1321 is configured to retain the cannula conduit 1354 therein.

[0089] As described above, the thumbwheel 1342 is configured to assist in feeding the guidewire 102 distally away from the guidewire management device 1300 by means of the first sleeve 1310. Consistent with the thumbwheel 1342, the guidewire conduit 1350 is configured to feed the guidewire 102 (or more specifically, the guidewire 102 arranged in the separable sleeve 904) distally into the second sleeve 1320. Depending on the polymer material chosen, the guidewire conduit 1350 can be opaque or translucent. When the guidewire conduit 1350 is translucent, it is configured to allow observation of the guidewire 102 while it is being fed distally into the second sleeve 1320. Additionally, the cannula conduit 1354 is configured to collect the separable sleeve 904 therein, which separates from the guidewire 102 while it is being fed distally away from the guidewire management device 1300. Similar to guidewire catheter 1350, depending on the selected polymer material, cannula catheter 1354 can be opaque or translucent. When cannula catheter 1354 is translucent, it is configured to allow observation of separable cannula 904, which separates from guidewire 102 and enters cannula catheter 1354 while simultaneously feeding guidewire 102 distally away from guidewire management device 1300.

[0090] As further explained above, the thumbwheel 1342 is also configured to assist in feeding the guidewire 102 proximally into the guidewire management device 1300 by means of the first sleeve 1310. Consistent with the thumbwheel 1342, the cannula 1354 is configured to feed a separable cannula 904, detached from the guidewire 102, into the first sleeve 1310 simultaneously with feeding the guidewire 102 distally away from the guidewire management device 1300, to combine with the guidewire 102 when it is fed proximally into the guidewire management device 1300. Similarly, the cannula 1354 can be opaque or translucent. When the cannula 1354 is translucent, it is configured to allow observation of the separable cannula 904 during proximal feeding into the guidewire management device 1300 for combination with the guidewire 102. The guidewire catheter 1350 is configured to collect the combination of the guidewire 102 and the separable cannula 904 while the guidewire 102 is being fed proximally into the guidewire management device 1300, preferably with the guidewire 102 rearranged within the separable cannula 904. Similarly, the guidewire catheter 1350 can be opaque or translucent. When the guidewire catheter 1350 is translucent, it is configured to allow observation of the combination of the guidewire 102 and the separable cannula 904 while the guidewire 102 is being fed proximally into the guidewire management device 1300.

[0091] Turning Figure 15 and 16 To describe at least some unique features of the guidewire management device 1500, the guidewire management device 1500 includes: a guidewire-cannula 1550 coupled to both a second sleeve 1520 and a first separation sleeve 1511 in the distal portion of a handle 1540. The handle 1540 may include a channel 1541 configured to retain the guidewire-cannula 1550 therein when the guidewire-cannula 1550 is in the coiled configuration shown.

[0092] Although there may be differences in one or more design elements, the first separating sleeve 1511 is similar to the first separating sleeve 911 or 1211 described above. Thus, the descriptions of the first separating sleeves 911 and 1211 described above should be understood to be extended to the first separating sleeve 1511 as if the first separating sleeve 1511 were included in the description of the first separating sleeve 911 or 1211.

[0093] As described above, the thumbwheel 1542 is configured to assist in feeding the guidewire 102 distally away from the guidewire management device 1500 by means of the first sleeve 1510. Consistent with the thumbwheel 1542, the guidewire-cannula 1550 is configured to feed the guidewire 102 (or more specifically, the guidewire 102 arranged in the separable cannula 904) distally into the second sleeve 1520. Depending on the polymer material chosen, the guidewire-cannula 1550 can be opaque or translucent. When the guidewire-cannula 1550 is translucent, it is configured to allow observation of the guidewire 102 while it is being fed distally into the second sleeve 1520. Additionally, the guidewire-cannula 1550 is configured to collect a separable cannula 904 therein, which separates from the guidewire 102 while simultaneously feeding the guidewire 102 distally away from the guidewire management device 1500. The distal end of the separable cannula 904, separated from the guidewire 102, is configured to follow the ball end of the guidewire 102 near the guidewire-cannula 1550 while simultaneously feeding the guidewire 102 distally away from the guidewire management device 1500. In practice, when the guidewire-cannula 1550 is semi-transparent, it is configured to allow observation of the separable cannula 904, which follows the ball end of the guidewire 102 near the guidewire-cannula 1550 while simultaneously feeding the guidewire 102 distally away from the guidewire management device 1500.

[0094] As further explained above, the thumbwheel 1542 is also configured to assist in feeding the guidewire 102 proximally into the guidewire management device 1500 by means of the first sleeve 1510. Consistent with the thumbwheel 1542, the guidewire-cannula 1550 is configured to feed a separable cannula 904, detached from the guidewire 102, into the first sleeve 1510 simultaneously with feeding the guidewire 102 distally away from the guidewire management device 1500, to combine with the guidewire 102 when the guidewire is fed proximally into the guidewire management device 1500. Similarly, the guidewire-cannula 1550 can be opaque or translucent. When the guidewire-cannula 1550 is translucent, it is configured to allow observation of the separable cannula 904 during proximal feeding into the guidewire management device 1500 for combination with the guidewire 102. The guidewire-cannula 1550 is configured to collect the combination of the guidewire 102 and the separable cannula 904 while the guidewire 102 is proximally fed into the guidewire management device 1500, preferably with the guidewire 102 rearranged within the separable cannula 904. When the guidewire-cannula 1550 is translucent, it is configured to allow observation of the combination of the guidewire 102 and the separable cannula 904 while the guidewire 102 is proximally fed into the guidewire management device 1500.

[0095] at last, Figure 17 A side view of the guidewire management device 1500 coupled to the catheter assembly 1702 according to some embodiments is provided. The connection between the guidewire management device 1500 and the catheter assembly 1702 via the Luer connector is shown in the figure, enabling one-handed guidewire management while holding the assembly 1700 via the handle 1540 of the guidewire management device 1500.

[0096] method

[0097] A method of using guidewire management device 100, 300, or 600 includes a connection step of connecting a first sleeve 110 or 610 of guidewire management device 100, 300, or 600 to the bushing of a medical device (e.g., a hollow needle) inserted into the patient's insertion site.

[0098] The method further includes an advancement step: advancing the guidewire 102 of the guidewire management device 100, 300, or 600 from the first sleeve 110 or 610 through the bushing of the medical device and into the patient's insertion site. As the guidewire 102 is advanced through the bushing of the medical device and into the patient's insertion site, a seal (e.g., an O-ring 114 or 714) in the first sleeve 110 or 610 prevents fluid (e.g., air) from escaping from the guidewire management device 100, 300, or 600.

[0099] The advancement step may include squeezing the guidewire 102 within the sterile barrier 104 or 304 and manually advancing the guidewire 102 into the first sleeve 110. Advancement may alternatively include pressing the guidewire 102 within the sterile barrier 104 onto the thumb wheel 742 and rolling the thumb wheel 742 to advance the guidewire 102 into the first sleeve 610.

[0100] In practice, the guide wire 102 can be pushed into the first sleeve 110 or 610 and removed from the guide wire management device 100 or 600 by: squeezing the assembly of the guide wire 102 in the bag 104 or pressing the guide wire 102 against the thumb wheel 742 in the bag 104, pushing the guide wire 102 into the first sleeve 110 by hand or by rolling the thumb wheel 742, releasing the assembly of the guide wire 102 in the bag 104, and repeating the above operations as needed. The guide wire 102 can also be pushed into the first sleeve 110 and removed from the guide wire management device 300 by: squeezing the assembly of the guide wire 102 in the cover 304, pushing the guide wire 102 into the first sleeve 110 by hand, releasing the assembly of the guide wire 102 in the cover 304, and repeating the above operations as needed.

[0101] The method may further include a termination step: stopping the advancement of the guidewire 102 into the patient's insertion site when the ball end of the guidewire 102 is caught in the contraction 124 of the hole 122 in the second sleeve 120 of the guidewire management device 100 or 300. Similarly, the termination step may include stopping the advancement of the guidewire 102 into the patient's insertion site when the ball end of the guidewire 102 is caught in the recess 724 in the second sleeve 620 of the guidewire management device 600.

[0102] The method further includes withdrawing the guidewire 102 from the patient's insertion site through the bushing of the medical device and into the first sleeve 110 or 610. When the guidewire 102 is withdrawn from the insertion site, a seal (e.g., an O-ring 114 or 714) in the first sleeve 110 or 610 prevents fluid (e.g., blood) from entering the guidewire management device 100, 300 or 600.

[0103] In practice, the guide wire 102 can be withdrawn into the guide wire management device 100 or 600 through the first sleeve 110 or 610 as follows: Squeeze the assembly of the guide wire 102 inside the bag 104 or press the guide wire 102 against the thumb wheel 742 inside the bag 104, withdraw the guide wire 102 from the first sleeve 110 by hand or by rolling the thumb wheel 742, release the assembly of the guide wire 102 inside the bag 104, and repeat the above operations as needed. The guide wire 102 can also be withdrawn into the guide wire management device 300 through the first sleeve 110 as follows: Squeeze the assembly of the guide wire 102 inside the cover 304, withdraw the guide wire 102 from the first sleeve 110 by hand, release the assembly of the guide wire 102 inside the cover 304, and repeat the above operations as needed.

[0104] The method may further include stopping the withdrawal of the guidewire 102 from the patient's insertion site when the proximal or ball end of the guidewire 102 abuts against the plug 152 in the proximal portion of the guidewire catheter 150 of the guidewire management device 100 or 300.

[0105] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A guidewire management device, comprising: handle; Guide wire; A first sleeve is formed in the distal portion of the handle; A second sleeve is formed in the proximal portion of the handle, and at least a portion of the guidewire extending between the first sleeve and the second sleeve is disposed within a sterile barrier configured to maintain the sterility of the guidewire. The sterile barrier is a separable cannula configured to detach from the guidewire while feeding the guidewire distally away from the guidewire management device. A thumbwheel is disposed below the guidewire between the first sleeve and the second sleeve. The thumbwheel is configured to feed the guidewire distally away from the guidewire management device with the assistance of the first sleeve or to feed the guidewire proximally into the guidewire management device with the assistance of the first sleeve. A guidewire conduit connected to the second sleeve, the guidewire conduit being configured to feed the guidewire distally into the second sleeve; and A cannula, which is connected to both a first dissociative sleeve in the distal portion of the handle and a second dissociative sleeve in the proximal portion of the handle, is configured to collect the dissociative cannula therein, the dissociative cannula separating from the guidewire as it is fed distally away from the guidewire management device.

2. The guide wire management device of claim 1, wherein the first sleeve has a distal portion configured as a convex connector with a Luer joint for connecting the first sleeve to a complementary concave connector.

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

4. The guidewire management device of claim 1, wherein the second sleeve has a proximal portion, the proximal portion including an orifice with a constriction portion configured to capture the ball end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

5. The guidewire management device of claim 1, wherein the separable sleeve is located over the entire guidewire except inside or distal to the first sleeve.

6. The guidewire management device of claim 1, wherein the handle includes a channel configured to retain the guidewire conduit in a coiled configuration.

7. The guidewire management device of claim 1, further comprising a guidewire-cannula conduit connected to both the second sleeve and a first disengagement sleeve in the distal portion of the handle, the guidewire-cannula conduit configured to feed the guidewire distally into the second sleeve and to collect the disengageable cannula therein by means of the first disengagement sleeve, the disengageable cannula separating from the guidewire as it is fed distally away from the guidewire management device.

8. The guidewire management device of claim 7, wherein the distal end of the separable cannula detached from the guidewire is configured to chase the proximal end of the guidewire near the guidewire-cannula while feeding the guidewire distally away from the guidewire management device.

9. The guidewire management device of claim 7, wherein the handle includes a channel configured to retain the guidewire-cannula in a coiled configuration.

10. The guidewire management device of claim 1, further comprising a flexible membrane extending from a distal portion of the handle above the thumb wheel to a proximal portion of the handle, the flexible membrane being configured to be pressed down on the thumb wheel to feed the guidewire distally away from the guidewire management device or to feed the guidewire proximally into the guidewire management device.

11. A guidewire management device, comprising: handle; Guide wire; A first sleeve is formed in the distal portion of the handle; A second sleeve is formed in the proximal portion of the handle, and at least a portion of the guidewire extending between the first sleeve and the second sleeve is disposed within a sterile barrier configured to maintain the sterility of the guidewire. The sterile barrier is a separable cannula configured to detach from the guidewire while feeding the guidewire distally away from the guidewire management device. A thumbwheel is disposed below the guidewire between the first sleeve and the second sleeve. The thumbwheel is configured to feed the guidewire distally away from the guidewire management device with the assistance of the first sleeve or to feed the guidewire proximally into the guidewire management device with the assistance of the first sleeve. and A guidewire-cannula conduit is connected to both a second sleeve and a first dissociative sleeve in the distal portion of the handle. The guidewire-cannula conduit is configured to feed the guidewire distally into the second sleeve and to collect the dissociative cannula therein by means of the first dissociative sleeve, the dissociative cannula separating from the guidewire as the guidewire is fed distally away from the guidewire management device.

12. The guide wire management device of claim 11, wherein the first sleeve has a distal portion configured as a convex connector with a Luer joint for connecting the first sleeve to a complementary concave connector.

13. The guidewire management device of claim 11, wherein the first sleeve is configured to straighten the 'J'-shaped tip in the distal portion of the guidewire when the tip of the guidewire enters the first sleeve as the guidewire is fed proximally into the guidewire management device.

14. The guidewire management device of claim 11, wherein the second sleeve has a proximal portion including an orifice with a constriction portion configured to capture the ball end of the guidewire and prevent the guidewire from passing completely through the second sleeve.

15. The guidewire management device of claim 11, wherein the separable sleeve is located over the entire guidewire except inside or distal to the first sleeve.

16. The guidewire management device of claim 11, wherein the distal end of the separable cannula detached from the guidewire is configured to chase the proximal end of the guidewire near the guidewire-cannula while feeding the guidewire distally away from the guidewire management device.

17. The guidewire management device of claim 11, wherein the handle includes a channel configured to retain the guidewire-cannula in a coiled configuration.

18. The guidewire management device of claim 11, further comprising a flexible membrane extending from a distal portion of the handle above the thumb wheel to a proximal portion of the handle, the flexible membrane being configured to be pressed down on the thumb wheel to feed the guidewire distally away from the guidewire management device or to feed the guidewire proximally into the guidewire management device.

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