Guidewire retention device

Abstract

An apparatus includes a dilator having a hub (38) and an elongated body (36). A locking mechanism (30) is configured to limit the distance a guidewire (28) can extend distally of the dilator. The guidewire has a guidewire stop (92B) that is capturable by the elongated dilator body (36). The guidewire lock (30) has at least one member movable between an engaged state and a disengaged state, and is biased toward the engaged state in which the guidewire lock interacts with the guidewire. The locking mechanism and the dilator are configured to allow the locking mechanism (30) to be removed from the dilator by axially moving the guidewire (28) in a proximal direction relative to the dilator with the guidewire stop abutting at least a portion of the locking mechanism through which the opening extends.

Description

[0001] This application is a divisional application of parent application number 201980028929.6, filed February 26, 2019, having the title "Guide Wire Retention Device".

[0002] INCORPORATION BY REFERENCE

[0003] The contents of U.S. Provisional Patent Application No. 62 / 637,317, filed March 1, 2018, U.S. Provisional Patent Application No. 62 / 648,522, filed March 27, 2018, and U.S. Patent Application No. 15 / 942,217, filed March 30, 2018, are hereby incorporated by reference as part of this disclosure. Any feature, structure, material, method or step described and / or illustrated in any embodiment of the above provisional patent applications can be used in combination with, or in place of, any feature, structure, material, method or step described in the following paragraphs of this specification and / or illustrated in the drawings accompanying the following paragraphs of this specification. TECHNICAL FIELD

[0004] The present disclosure relates generally to access devices for introducing and / or delivering medical articles (e.g., catheters, cannulas, sheaths, etc.) into a body space such as an artery, vein, vessel, body cavity, or drainage site, and more particularly to devices including structures for interlocking or engaging with a guide wire. BACKGROUND

[0005] One preferred non-surgical method for inserting a catheter or vascular sheath into a blood vessel includes using a percutaneous (Seldinger) technique or a modified percutaneous technique that includes an access needle inserted into a patient's blood vessel. A guide wire is inserted through the needle into the blood vessel, the needle is then removed, and a dilator and sheath are inserted over or separately over the guide wire, and then the dilator and sheath are inserted together or separately through the tissue into the blood vessel a short distance, after which the dilator and guide wire are removed and discarded. A catheter or other medical article can then be inserted through the sheath into the blood vessel to a desired location, or the sheath can simply be left in the blood vessel.

[0006] The above technique requires a swap over the guide wire, which presents a risk of losing the cannula, losing the guide wire, and contamination. The overall technique is a time-intensive dangerous move, which is a move of the medical article and guide wire relative to the patient. Thus, there is a need for a more user-friendly and safer vascular access device, particularly one that reduces the risk of accidental embolization and other risks associated with over-torquing a vascular access. SUMMARY

[0007] The access devices described herein advantageously provide improved mechanisms for safely effecting placement of medical devices within the vasculature. Without limiting the scope of the disclosure, its more prominent features will be discussed briefly. With the discussion in mind, and particularly in conjunction with the detailed description of the preferred embodiments presented later in this section, it will be understood how the features and aspects of these embodiments provide a number of advantages over prior access devices.

[0008] One aspect is an access device for placing a medical article within a body space, the access device comprising a dilator having a hub and an elongate dilator body extending from the hub. The access device further comprises a guidewire configured to slide within the dilator body and having a guidewire stop. The access device further comprises a locking mechanism supported by the dilator and having a guidewire lock. The locking mechanism is configured to interlock with the guidewire at least when the dilator is passed over the guidewire and the guidewire lock is in axial alignment with the guidewire stop.

[0009] Another aspect is an access device for placing a medical article within a body space, the access device comprising a guidewire having a guidewire stop and a dilator. The dilator is configured to be disposed coaxially with the guidewire. The access device further comprises a locking mechanism disposed on the dilator, the locking mechanism configured to move from an unlocked state to a locked state. When the locking mechanism is in the unlocked state, the locking mechanism is disengaged from the guidewire, thereby allowing the guidewire to move axially in a proximal direction and a distal direction through the locking mechanism. When the locking mechanism is in the locked state, the locking mechanism is engaged with the guidewire, thereby limiting axial movement of at least a portion of the guidewire relative to at least a portion of the dilator in the distal direction.

[0010] Yet another aspect is a method of limiting a distance that a guidewire can extend from a distal end of a dilator and into a patient. The method comprises piercing a patient with a needle having an inner bore, sliding the guidewire through the inner bore and into the patient, and removing the needle from the patient. The method further comprises threading the dilator over the guidewire and into the patient. The dilator comprises a locking mechanism configured to receive and interlock to the guidewire so as to inhibit at least relative axial movement between at least a portion of the guidewire and at least a portion of the dilator in one direction.

[0011] The locking mechanism can comprise an attachment to at least a region of the guidewire such that the guidewire is not inadvertently advanced too far into the patient, causing a loss or embolization of the guidewire within the vasculature.

[0012] The locking mechanism can be configured to maintain a maximum guidewire length beyond a tip of the needle upon advancement. The locking mechanism can be configured to retain the guidewire to the access device such that the guidewire is not misplaced or lost within the patient.

[0013] In some embodiments, the locking mechanism (adjustable) limits the extent to which the guidewire can move (e.g., advance) relative to the needle. In some modes, a groove or recess can be provided at the proximal end region of the guidewire to avoid the proximal region from disengaging from the locking mechanism and into the patient. In other modes, a groove or recess can be provided at other locations along the guidewire to help adjust the length of the guidewire that can extend from the needle tip. Preferably, there is an interaction (e.g., interference, engagement, friction, mechanical coupling, adhesion, etc.) between the guidewire and the locking mechanism to inhibit relative motion between these components.

[0014] These and other aspects of the application will become apparent to those skilled in the art from the following detailed description of the preferred embodiments, when considered in light of the accompanying drawings. The present application, however, is not limited to the specific embodiments disclosed. BRIEF DESCRIPTION OF DRAWINGS

[0015] These and other features, aspects, and advantages of the access devices disclosed herein are described in more detail below with reference to various embodiments illustrated in the drawings, which are intended to illustrate but not limit the present application. Additionally, in the various drawings, like reference numerals are used to denote like parts throughout the several views. A brief description of each drawing is as follows.

[0016] FIG. 1 is an isometric view of an embodiment of an access device including a dilator coaxially aligned with a sheath, a guidewire is shown.

[0017] FIG. 2A is a side view of a needle that can be used to assist in the insertion of a guidewire of FIG. 1 into a patient.

[0018] FIG. 2B is a side cross-sectional view of the needle of FIG. 2A along line 2B-2B.

[0019] FIG. 3A is a top view of the dilator of the access device of FIG. 1 including a locking mechanism.

[0020] FIG. 3B is a side cross-sectional view of the dilator of FIG. 3A along line 3B-3B.

[0021] FIG. 4A is an enlarged view of the portion of the dilator of FIG. 3A that lies within the range of line 4A-4A, the dilator including a receptacle configured to receive a locking mechanism.

[0022] FIG. 4B is a cross-sectional view of the dilator of FIG. 4A along line 4B-4B of FIG. 4C .

[0023] FIG. 4C is FIG. 4A an end view of the dilator in a distal direction.

[0024] FIG. 5A is FIG. 1 a proximal end view of the sheath of the access device of

[0025] FIG. 5B is FIG. 5A a side view of the sheath of

[0026] FIG. 6 is FIG. 1 a cross-sectional view of the access device of

[0027] FIG. 6 is FIG. 7A a view of the proximal end region of one embodiment of the guidewire shown in

[0028] FIG. 1 is FIG. 7B a view of the proximal end region of another embodiment of the guidewire shown in

[0029] FIG. 1 is FIG. 8 a front isometric view of the locking mechanism of

[0030] FIG. 4A is FIG. 9 a back isometric view of the locking mechanism of

[0031] FIG. 8 is FIG. 10 a front isometric view of the locking mechanism in an open state to allow the guidewire to pass through the locking mechanism when the dilator and sheath are passed over the guidewire.

[0032] FIG. 8 is FIG. 11 a back isometric view of the locking mechanism in a locked state in

[0033] FIG. 10 is FIG. 11A a close-up side view of the locking mechanism of FIG. 11 interlocking with the guidewire stop of the guidewire of

[0034] FIG. 7A is FIG. 11B a close-up side view of the locking mechanism of FIG. 11 interlocking with the guidewire stop of the guidewire of

[0035] FIG. 7B is FIG. 12A a side view of the needle piercing the body.

[0036] FIG. 2A is FIG. 12B an enlarged side view of the distal end of the needle circumscribed by line 12B-12B.

[0037] FIG. 12A is FIG. 13A a cross-sectional view of the needle piercing the vasculature.

[0038] FIG. 12A is FIG. 13B an enlarged side view of the distal end of the needle circumscribed by line 13B-13B.

[0039] FIG. 13A is FIG. 14 a side view of the needle with the guidewire having been passed through the needle and fed into the patient's vasculature.

[0040] FIG. 13A is FIG. 15 a cross-sectional view of the needle with the guidewire having been extended into the patient's vasculature.

[0041] FIG. 14 is FIG. 16A a side view of the dilator and sheath of FIG. 1 having been slid along the outside of the guidewire of until the locking mechanism in the dilator interlocks with the guidewire stop.

[0042] FIG. 15 FIG. 16B is an enlarged side view of a portion of the dilator and sheath of

[0043] circumscribed by line 16B-16B. FIG. 16A FIG. 16C is

[0044] a side view of the dilator and sheath of FIG. 16B wherein the dilator and sheath have been slid further along the outside of the guidewire into the patient's vasculature, thereby separating the dilator from the locking mechanism. FIG. 17

[0045] is FIG. 16A a side view of the dilator and sheath of FIG. 18 wherein the guidewire and interlocked locking mechanism have been withdrawn from the dilator and sheath.

[0046] FIG. 17 is FIG. 19A side sectional view of the expander and sheath, with the expander removed from the patient and the sheath removed.

[0047] FIG. 18 yes FIG. 20 A cross-sectional view of the sheath, in which the catheter is aligned with the sheath for insertion into the patient's vascular system.

[0048] FIG. 19 yes FIG. 21 A lateral sectional view of the sheath, in which the catheter is inserted through the sheath and into the patient's vascular system.

[0049] FIG. 20 yes FIG. 22 A side sectional view of the sheath, in which the two parts of the sheath are peeled off from each other so that the sheath no longer surrounds the catheter.

[0050] FIG. 21 This is a front view of one embodiment of the locking mechanism.

[0051] FIG. 23A yes FIG. 23B Rear view of the locking mechanism.

[0052] FIG. 23A yes FIG. 23C A sectional view along the locking line 23C-23C.

[0053] FIG. 23A yes FIG. 24A A side sectional view of the locking mechanism, in which a guide wire is inserted through the locking mechanism.

[0054] FIG. 23A yes FIG. 24B Side sectional view of the locking mechanism interlocked with the guidewire.

[0055] FIG. 24A This is a front view of one embodiment of the locking mechanism.

[0056] FIG. 25A yes FIG. 25B Side section view along the locking line 25B-25B.

[0057] FIG. 25A yes FIG. 26A A side sectional view of the locking mechanism, which is attached to the expander, and a guide wire inserted through the locking mechanism.

[0058] FIG. 25A yes FIG. 26B A cross-sectional view of the locking mechanism that interlocks with the guidewire.

[0059] FIG. 25A This is a side sectional view of one embodiment of a locking mechanism that engages with an expander and has a guide wire inserted through the locking mechanism.

[0060] FIG. 27A is a side cross-sectional view of the locking mechanism interlocked with a guidewire. FIG. 27B

[0061] FIG. 27A is a front view of one embodiment of the locking mechanism.

[0062] FIG. 28A is a rear view of the locking mechanism. FIG. 28B

[0063] FIG. 28A is a side cross-sectional view of the locking mechanism along line 28C-28C. FIG. 28C

[0064] FIG. 28A is a side cross-sectional view of the locking mechanism interlocked with a guidewire. FIG. 29A

[0065] FIG. 28A FIG. 29B DETAILED DESCRIPTION

[0066] The present disclosure provides an access device for delivering a medical article (e.g., a catheter or sheath) to a blood vessel or drainage site. FIG. 28A One access device 20 configured to be inserted into a blood vessel (e.g., a vein or artery) is shown in accordance with embodiments discussed herein. Although the access device (e.g., for vascular access) is described below in the context, the device can also be used to access and place a medical article (e.g., a catheter or sheath) into other sites (e.g., drainage sites) in a patient’s body and into the respective sites, as well as for other purposes (e.g., draining an abscess).

[0067] ​​​​​​In some embodiments, the access devices disclosed in the context place exemplary single-piece tubular medical articles into a body space within a patient. Once placed, the tubular article can be used to house other medical articles (e.g., catheters, guide wires, etc.) to provide access to the body space and / or to provide access for the introduction of fluids into the body space, or the removal (e.g., drainage) of fluids from the body space. As the embodiments illustrate, the tubular medical article can be a sheath or catheter that is primarily configured to provide fluid access to a vein. However, the present disclosure should not be interpreted as being limited to the placement of single-piece sheaths or catheters, or the subsequent insertion of medical articles through the sheath or catheter. Rather, in accordance with the present disclosure, those skilled in the art will appreciate that the access devices disclosed herein can also be successfully used in conjunction with the placement of one or more other types of medical articles. Other types of medical articles include other types of sheaths, fluid drainage and delivery tubes, and single or multi-lumen catheters that are placed within the patient directly or indirectly through another medical article.

[0068] For example, and without limitation, the access devices disclosed herein can be configured to place central venous catheters, peripheral inserted central catheters, hemodialysis catheters, surgical drainage tubes, peel-away sheaths, multi-piece sheaths, scopes, and sleeves for electrical wires or cables that connect to external or implanted electronic devices or sensors directly or indirectly. The medical articles listed herein can be placed within the patient directly through the dilator and guide wire of the access device, or the medical articles placed within the patient through the dilator and guide wire of the access device subsequently.

[0069] Embodiments of the present disclosure are not limited to the coaxial insertion of a single medical article. For example, two catheters can be inserted into a patient through an inserted sheath, or a second catheter can be inserted into a patient through a first catheter that is inserted. In some cases, the medical article inserted through the dilator and guide wire can form a lumen in addition to the lumen of the subsequently inserted medical article. Other applications of the devices and systems disclosed herein can also be found by those skilled in the art. Thus, the illustration and description of the access device in conjunction with a sheath (e.g., for micro-puncture applications) is merely an example of one possible application of the access device.

[0070] FIG. 1 is an isometric view of an embodiment of an access device 20 that includes a dilator 24 coaxially aligned with a sheath 26, and further showing a guide wire 28. FIG. 1 The components of the access device 20 shown include a dilator 24 and a sheath 26. In the embodiment shown, the access device 20 further includes a guide wire 28. The sheath 26 can be coaxially mounted on the dilator 24. The telescoping capability of the components of the access device is achieved by arranging the components with their axes arranged substantially parallel, rather than coaxial (e.g., a single rail design).

[0071] Each of these components includes a lumen fitting at an end or transition (e.g., a hub) and an elongate structure extending from the fitting. Thus, in the illustrated embodiment, dilator 24 includes dilator shaft 36 extending distally from dilator hub 38, and sheath 26 includes sheath body 40 extending distally from sheath hub 42. In certain embodiments, guidewire 28 includes a guidewire hub or cap.

[0072] As FIG. 1 illustrated, access device 20 further includes a stop or locking mechanism 30. Locking mechanism 30 forms one or more interlocks or interconnections between locking mechanism 30 and one or more other components of guidewire and / or access device 20. In certain embodiments, locking mechanism 30 provides a first interlock between locking mechanism 30 and guidewire 28. In certain embodiments, locking mechanism 30 further forms a second interlock between locking mechanism 30 and another component of access device 20. For example, in certain implementations, the first and second interlocks of locking mechanism 30 can respectively engage guidewire 28 and dilator 24. Locking mechanism 30 need not include both a first and second interlock. In certain embodiments, locking mechanism 30 further locks to another component of access device 20. For example, locking mechanism 30 can include an interlock for locking to sheath 26.

[0073] The phrase "interlock" denotes a feature of locking mechanism 30 that inhibits movement of locking mechanism 30 in at least one direction relative to a component of access device 20. The interlock can be an interaction (e.g., interference, engagement, friction, mechanical coupling, mechanical interconnection, mechanical interaction, adhesion, etc.). For example, in certain embodiments, such a feature includes one or more structures of locking mechanism 30, such as tabs, teeth, grooves, etc., as well as the size or shape of locking mechanism 30 itself. For example, the exterior of locking mechanism 30 can be sized and shaped to inhibit movement of locking mechanism 30 relative to an interior surface of a component of access device 20 via contact between the exterior and the interior surface.

[0074] Locking mechanism 30 is configured to prevent the proximal portion of guidewire 28 from advancing too far through dilator 24. Advancing guidewire 28 beyond the proximal end of dilator 24 creates a risk of the guidewire becoming lost within the vessel. Moreover, even if guidewire 28 does not advance beyond the proximal end of dilator 24, there is a risk when dilator 24 is withdrawn from sheath 26. This risk is that the friction created between flowing blood and guidewire 28 inserted into the blood pulls guidewire 28 into the vessel. In certain embodiments, locking mechanism 30 allows guidewire 28 to be withdrawn from access device 20 substantially simultaneously with dilator 24.

[0075] In certain embodiments, the advanced guidewire 28 is prevented from being withdrawn into the dilator 24. For example, the interlock between the locking mechanism 30 and the guidewire 28 can inhibit proximal and / or distal movement of the guidewire 28 relative to the dilator 24. Such an arrangement can reduce the risk of breaking off the distal end of the guidewire 28 and having the distal end of the guidewire 28 enter the vasculature.

[0076] FIG. 3B-4C is a side view of a needle 22 that can be used to insert a guidewire 28 into a patient in FIG. 2A is a side view of a needle 22 that can be used to insert a guidewire 28 into a patient in FIG. 1 is a side view of a needle 22 that can be used to insert a guidewire 28 into a patient in FIG. 2B is a side view of a needle 22 that can be used to insert a guidewire 28 into a patient in FIG. 2A is a side view of a needle 22 that can be used to insert a guidewire 28 into a patient in

[0077] Preferably, the needle body 32 is elongated and tubular with a circular, constant diameter inner bore 54 and a circular, constant diameter outer surface. However, in other embodiments, the needle body 32 can have other bore and outer shapes (e.g., but not limited to, an oval cross-section). The interior or exterior of the needle 22 can also include grooves or channels. The grooves or channels can direct fluid around or to certain structures of the needle 22 within the needle bore, or within the needle 22 (e.g., around the guidewire 28). In some embodiments, the grooves or channels can help maintain the needle 22 in a desired orientation relative to the dilator 24.

[0078] The needle body 32 has a length sufficient to access a target subcutaneous body space and a gauge size large enough to withstand insertion forces into the body space without causing undue trauma. For many applications, the needle body 32 is 3-20 cm in length (e.g., between 3-10 cm). For example, to access a body space (e.g., a blood vessel) within the thoracic cavity of an adult human, the needle body 32 is preferably 7 cm or more in length, more preferably 9 cm or more, and most preferably 9-10 cm in length. The needle 22 is preferably 18 gauge or smaller (e.g., between 18-28 gauge, or between 18-26 gauge for minimally invasive puncture applications (peripheral vein)). For neonatal applications, the needle body 32 should be significantly shorter and smaller in gauge, e.g., 3-4 cm in length and 26-28 gauge. The needle body 32 can have a beveled tip 52 disposed on the distal end portion 48.

[0079] As explained in greater detail below, the guidewire 28 is introduced into the punctured blood vessel from the hollow portion 68 of the needle hub 34 and through the needle body 32. After the needle 22 is removed from the patient, the remaining guidewire 28 allows the medical practitioner to guide the dilator 24 and sheath 26 into the blood vessel.

[0080] FIG. 2B is usable with the access device 20 of FIG. 3A is a top view of the dilator 24 including the locking mechanism 30 usable with the access device 20 of FIG. 1 is FIG. 3B is a side cross-sectional view of the dilator 24 along 3B-3B of

[0081] FIG. 3A is FIG. 4A is an enlarged view of the portion of the dilator shown in the range of line 4A-4A. The dilator 24 includes a receptacle 74. In some embodiments, the receptacle is configured to house the locking mechanism 30. However, the locking mechanism 30 need not be located within the dilator 24. In some embodiments, the locking mechanism 30 is located on top of the dilator 24 or outside of the dilator 24 so long as the guidewire 28 passes through the locking mechanism 30.

[0082] In some embodiments, the receptacle 74 is sized and shaped to allow the locking mechanism 30 to be housed in the dilator hub 38. The locking mechanism 30 can be removed from the receptacle 74 after interlocking with the guidewire 28.

[0083] The locking mechanism 30 can be removably engaged with at least a portion of the dilator hub 38 such that the locking mechanism 30 can be moved into or out of the receptacle 74 as the dilator hub 38 slides along the guidewire 28 in the proximal or distal direction, respectively. For example, the locking mechanism 30 can be removably retained within the receptacle 74 via any suitable interaction (e.g., interference, engagement, friction, mechanical coupling, adhesion, etc.). In some embodiments, once the locking mechanism 30 is interlocked with the guidewire 28 and abuts a surface of the receptacle 74, further movement of the guidewire 28 relative to the distal end of the dilator 24 can be prevented. In such embodiments, the locking mechanism 30 is interlocked with the guidewire 28 such that the guidewire 28 and the locking mechanism 30 move in unison during removal of the guidewire 28. In some embodiments, once the locking mechanism 30 is interlocked with the guidewire 28, further proximal movement of the guidewire 28 relative to the dilator 24 can be sufficient to overcome the interaction force that removably retains the locking mechanism 30 in the receptacle 74. For example, after the locking mechanism 30 is engaged with the guidewire 28, the guidewire 28 is moved in the proximal direction relative to the dilator 24 by applying a sustained pulling force, thereby removing the locking mechanism 30 from the receptacle 74. In some embodiments, one or more walls, such as the bottom surface 58 of the receptacle 74, can prevent distal movement of the locking mechanism 30 relative to the receptacle 74.

[0084] FIG. 4A is FIG. 4B is an enlarged view of the portion of the dilator shown in the range of line 4A-4A. The dilator 24 includes a receptacle 74. In some embodiments, the receptacle is configured to house the locking mechanism 30. However, the locking mechanism 30 need not be located within the dilator 24. In some embodiments, the locking mechanism 30 is located on top of the dilator 24 or outside of the dilator 24 so long as the guidewire 28 passes through the locking mechanism 30. FIG. 4ASectional view of line 4B-4B. FIG. 4C yes FIG. 4C The distal view of the expander 24 shown.

[0085] The expander bushing 38 may include locking structures at the proximal region 72 and distal region 70 of the expander 24. Each locking structure may be a Luer-type or other type of connection. In the illustrated embodiment, the expander bushing 38 includes a Luer connector 78. In some embodiments, the Luer connector 78 (e.g., a male Luer sliding joint) is capable of engaging with... FIG. 4A The sheath bushing 42 (e.g., a female Luer sliding joint) on the sheath 26 shown engages. Furthermore, the male and female Luer sliding joints on these components are interchangeable.

[0086] The color of the dilator 24 can be selected to increase the contrast between the dilator 24 and the blood or other fluid. For example, during blood flow, the flow of blood between the dilator 24 and the sheath 26 can be observed to confirm proper placement in the blood vessel. To increase visibility of the fluid flowing between the sheath 26 and the dilator 24, the sheath 26 is preferably made of a clear or transparent material, and the color of the dilator 24 contrasts with the color of the fluid. For example, the dilator 24 can be white to enhance its contrast with red blood. Depending on the color of the fluid and the desired contrast, the dilator 24 can also be other colors. Furthermore, only a portion of the dilator 24 with a different color located in the blood can be set as a contrasting color.

[0087] In use, the dilator 24 expands the opening or channel formed by the needle 22. The expanded channel facilitates the subsequent introduction of the sheath 26. The needle 22 allows the guidewire 28, followed by the dilator 24, and finally the sheath 26 to be introduced into the patient's body.

[0088] FIG. 5B Is it possible to... FIG. 5A End view of the sheath 26 used in conjunction with the passage device 20. FIG. 1 yes FIG. 5B The image shows a side view of the sheath 26. The sheath 26 includes a sheath body 40, a sheath bushing 42, a distal region 86, and a proximal region 88. The sheath body 40 may be partially or entirely made of a clear, translucent, transparent, or translucent material. The sheath body 40 may also include one or more radiopaque markings, such as barium sulfate stripes. In a preferred embodiment, the sheath includes two such radiopaque stripes arranged on completely opposite sides of the sheath body 40.

[0089] Sheath body 40 can be a single piece sheath through which a catheter or other medical article is inserted into a blood vessel. In such embodiments, sheath body 40 forms a conduit for insertion of a catheter or other medical article. In addition to providing a conduit, sheath 26 or a portion of the sheath can form a lumen in addition to the lumen of the catheter. For example, a catheter equivalent to a three-lumen catheter can be formed by inserting a dual lumen catheter through sheath body 40 such that sheath body 40 itself forms a third lumen.

[0090] Depending on the type of catheter or medical article to be inserted into a blood vessel after use of access device 20, it can be beneficial to remove a portion or the entire sheath body 40. For example, a portion of sheath body 40 can be separated or peeled away and removed after a catheter or other medical article is inserted into a blood vessel. A peel-away sheath can include perforations, serrations, tabs or other structures, or include other materials (e.g., bismuth-impregnated polytetrafluoroethylene) to allow a physician or medical staff to easily remove a portion or the entire sheath body 40.

[0091] Sheath hub 42 can include a luer slip connector 90. Luer slip connector 90 can include locking or attachment structures that mate or engage with corresponding structures. For example, luer slip connector 90 can be configured to engage with luer connector 78 of dilator hub 38.

[0092] As FIG. 5A As best shown, preferably, sheath hub 42 is designed such that luer connector 78 of dilator hub 38 can enter sheath hub 42 substantially unimpeded. However, in use, once sheath hub 42 is placed in a desired position on dilator shaft 36, a physician or medical staff can push, pull or twist sheath hub 42 and cause luer slip connector 90 to disengage or engage with a corresponding fitting on another medical article. Luer slip connector 90 creates a mechanical fit such that dilator hub 38 and sheath hub 42 can be releasably interlocked. Preferably, sheath hub 42 engages with corresponding luer connector 78 on dilator hub 38. Preferably, the locking site can be disengaged or engaged by pulling, pressing, pushing or twisting dilator hub 38 relative to sheath hub 42.

[0093] In further embodiments, sheath hub 42 can include radially extending wings or handle structures to allow sheath body 40 to be easily released and removed from other portions of access device 20. In some applications, the wings are also sized to provide leverage for a medical staff member to separate sheath hub 42. For example, sheath hub 42 can include a film for connecting two halves of sheath hub 42, the film being sized such that the two halves of sheath hub 42 can be held together until a medical staff member removes sheath hub 42 from access device 20. The medical staff member manipulates the wings to break the film and separate sheath hub 42 into two removable halves.

[0094] FIG. 5A is FIG. 6 is a side cross-sectional view of the access device 20 after the passage of the guidewire 28. Thus, in the illustrated embodiment, the dilator 24 includes a dilator shaft 36 extending distally from a dilator hub 38, and the sheath 26 includes a sheath body 40 extending distally from a sheath hub 42. In certain embodiments, the guidewire 28 includes a guidewire hub or guidewire cap (not shown). In the illustrated embodiment, the dilator 24 and the sheath 26 are releasably interlocked at the proximal end of the access device 20. In some embodiments, the releasable interlock between the dilator 24 and the sheath 26 is a linear interlock, in which the sheath 26 is locked onto the dilator 24. FIG. 1 illustrates the relative position of the distal end of the dilator 24 to the distal end of the sheath 26. For example, the distal end of the dilator body 36 extends beyond the distal end of the sheath 26.

[0095] FIG. 6 and 7B is FIG. 7A are various views of the proximal end region 94 of the guidewire 28, showing guidewire stops 92A, 92B configured for use by the locking mechanism 30 to secure to the guidewire 28. In certain embodiments, the guidewire stops 92A, 92B are one or more features of the guidewire 28 that allow the locking mechanism 30 to engage the guidewire 28. In FIG. 1 In the illustrated embodiment, the guidewire stop 92A is in the form of an annular groove defined by one or more ridges (e.g., two ridges). As described herein, the groove can be sized and configured to engage with a corresponding locking mechanism 30. Although the illustrated guidewire stop 92A is a groove, those skilled in the art will appreciate that the guidewire stop can include any shape or size that is capable of engaging with the locking mechanism 30. For example, as FIG. 7A As illustrated, the guidewire stop 92B can include an outward protrusion configured to inhibit further distal movement of the guidewire 28 relative to the locking mechanism 30 once the guidewire stop 92B is abutting and / or engaging the locking mechanism 30. The guidewire stop 92B can function in a similar manner as the guidewire stop 92A. In some cases, the guidewire stop 92B can include one or more outward protrusions (e.g., cams) protruding from one or more sides of the guidewire 28. The one or more cams can be sized and configured to be engaged by the opposing jaws 80 when they pass in a proximal direction relative to the locking mechanism 30, as described herein, and FIG. 7B and FIG. 8When the one or more cams pass through the pair of jaws 80, the pair of jaws 80 can close behind the one or more cams to prevent movement of the one or more cams relative to the distal end of the pair of jaws 80. Additionally, while the guidewire stops 92A, 92B are shown as being located at the proximal end region 94 of the guidewire 28, those skilled in the art will appreciate that the guidewire stops 92A, 92B can be disposed at any location along the guidewire 28. In certain other embodiments, the guidewire stops can be notches, tapers, barbs, adhesives, magnets, or other features.

[0096] In certain instances, the guidewire stops 92A, 92B can be formed by altering the width of the guidewire 28. For example, the guidewire 92B can include a portion of the guidewire 28 having an increased width relative to other portions of the guidewire 28. The portion of the guidewire 92B having the increased width can be followed by a portion of the guidewire 28 having a reduced width, which is located distal and proximal to the guidewire stop 92B. As described herein, the increased width of the guidewire stop 92B can be sized and configured to allow the locking mechanism 30 to engage the guidewire stop 92B, while also having a sufficient width to inhibit the guidewire stop 92B from passing through the opening 82 of the locking mechanism 30. The increased width of the guidewire stop 92B is configured to engage the locking mechanism 30, while also allowing the guidewire stop 92B to pass through the inner bore 54 of the needle 22. For example, the outer width of the guidewire stop 92B can be less than the inner diameter of the inner bore 54 of the needle 22. The increased width of the guidewire stop 92B can be formed in any suitable manner, for example, the guidewire stop 92B can include an annular flange along the guidewire 28. As another example, the guidewire stop 92B can be formed by stamping and / or compressing a portion of the guidewire 28 to shape the guidewire stop 92. The guidewire stop 92 has a compressed surface having an increased width that protrudes outwardly along the guidewire 28.

[0097] Preferably, the guidewire stops 92A, 92B are disposed at the proximal end region 94 of the guidewire 28 and are configured to engage the locking mechanism 30 at least when the dilator 24 is passed over the guidewire 28. Until the guidewire stops 92A, 92B interlock with the locking mechanism 30 and cause the locking mechanism 30 and / or the guidewire stops 92A, 92B to abut against the wall 58, the medical professional can freely manipulate the guidewire 28 within the dilator 24. However, after the guidewire stops 92A, 92B interlock and then contact the wall 58, the medical professional can not further extend the guidewire distally relative to the dilator 24.

[0098] In certain embodiments, when the guidewire 28 is initially threaded through the dilator hub 38, the locking mechanism 30 encircles the outer surface of the guidewire 28 to pinch the guidewire 28. In certain instances, the pinching force can not be sufficient to engage with the guidewire 28. In certain embodiments, the bite force exerted by the locking mechanism 30 on the guidewire 28 is not sufficient to prevent the guidewire 28 from moving relative to the locking mechanism 30. The bite force exerted by the locking mechanism 30 on the guidewire 28 can still allow the guidewire 28 to move relative to the locking mechanism 30 until the locking mechanism 30 interlocks or engages with the guidewire stops 92A, 92B. For example, the locking mechanism 30 can not sufficiently block the guidewire 28 from passing through the locking mechanism 30 until the locking mechanism 30 engages with the guidewire stops 92A, 92B. Once the locking mechanism 30 engages with the guidewire stops 92A, 92B, the locking mechanism 30 inhibits at least further distal movement of the guidewire 28 relative to the locking mechanism 30.

[0099] FIG. 9 is FIG. 8 an isometric view of the locking mechanism 30 disengaged from the dilator 36. FIG. 4A is an isometric view of the opposite end of the locking mechanism 30 from FIG. 9 . As described herein, the dilator hub 38 includes the locking mechanism 30. In certain embodiments, the locking mechanism 30 is disposed in the sheath 26 or other medical article. The locking mechanism 30 can be configured to lock or secure to the guidewire 28. As FIG. 8 and FIG. 8 illustrated, the locking mechanism 30 includes a guidewire lock 44 and an opening 82. The guidewire lock 44 can include one or more engagement mechanisms, such as a pair of opposing clips, teeth, tabs, or openings, although other types of locking mechanisms including tabs and / or slots can be used.

[0100] In the illustrated embodiment, the guidewire lock 44 is configured as a pair of opposing clips 80. The locking mechanism 30 is generally V-shaped and configured to bias toward a closed state while still allowing the locking mechanism 30 to slide over the guidewire 28 and then snap to the guidewire stops 92A, 92B as the guidewire 28 is advanced through the V-shaped locking mechanism 30.

[0101] FIG. 9 is a view similar to FIG. 10 , except that the guidewire lock 44 is open or in an unlocked state, allowing the guidewire 28 to pass through the locking mechanism 30 as the dilator 24 and sheath 26 are threaded over the guidewire 28. As FIG. 8 illustrated, the guidewire lock 44 can be biased toward a closed configuration. The degree to which the guidewire lock 44 is biased toward the closed state is selected such that the guidewire 28 can slide through the guidewire lock 44 when the guidewire lock 44 is not in contact or engagement with the stops 92A, 92B. When the guidewire lock 44 is engaged with the guidewire stops 92A, 92B, the guidewire lock 44 is in a locked state (asFIG. 8 , 11A (as shown in 11B).

[0102] FIG. 11 Is with FIG. 11 A similar view, but taken from the opposite end of the locking mechanism 30, with the guide wire 28 further inserted into the expander 24 and sheath 26 until the locking mechanism 30 interlocks with the wire stops 92A, 92B on the guide wire 28. FIG. 10 yes FIG. 11A A partially enlarged cross-sectional view showing the interlocking of the locking mechanism 30 with the guide wire stop 92A on the guide wire 28. As another example, FIG. 11 yes FIG. 11B A partially enlarged cross-sectional view showing the locking mechanism 30 interlocking with the guide wire stops 92B on the guide wire 28. In the illustrated embodiment, the locking mechanism 30 has slid distally relative to the guide wire 28 until it interlocks with the guide wire stops 92A, 92B on the guide wire 28. The clamps 80 of the guide wire lock 44 can engage with protruding and / or recessed surfaces such as the guide wire stops 92A, 92B as shown in FIG. 7. Once engaged, the guide wire lock 44 prevents undesirable sliding or release of the guide wire stops 92A, 92B relative to the locking mechanism 30. The guide wire 28 can substantially carry the locking mechanism 30 and move in unison with it. In some embodiments, the guide wire lock 44 is hinged to provide a bias toward the center of the dilator bushing 38. This bias prevents the fixed portion of the guide wire 28 from sliding or disengaging from the guide wire lock 44.

[0103] FIG. 11 The interlocking structure shown is merely one example of a type of mating structure, which may include interconnecting or interlocking the locking mechanism 30 with the guidewire 28 and / or the dilator 24. In some embodiments, the interlocking does not engage with the guidewire 28 until the dilator 24 is fully threaded over the guidewire 28 to allow the interlocking structure to contact the guidewire lock 44. In this way, the interlocking structure does not inhibit use or significantly increase contact friction as the medical personnel manipulate the guidewire 28 until the guidewire lock 44 contacts the guidewire stops 92A, 92B.

[0104] FIG. 8-11 and 27B These are various views of the locking mechanism 30 and the expander bushing 38 according to some embodiments. In some cases, at least a portion of the locking mechanism 30 (e.g., FIG. 27A The opposing clips 80A and 80B shown can engage with a portion of the expander bushing 38 to hold the locking mechanism 30 in the open position from its initial state. (See details below.) FIG. 27A and 27BAs shown, the locking mechanism 30 may have a first open state located on the expander bushing 38 and a second closed state located on and / or engaged with the guide wire 28.

[0105] like FIG. 27A As shown, when the locking mechanism 30 is in the open position, the locking mechanism 30 can be arranged along a portion of the expander bushing 38. The locking mechanism 30 can be clamped, pre-formed, or otherwise arranged on or around at least a portion of the expander bushing 38 to temporarily hold the locking mechanism 30 in the open position and prevent the locking mechanism 30 from entering the closed position. The inner surface of the expander bushing 38 may include a platform, groove, ridge, or any suitable protrusion, and the inner surface of the expander bushing 38 is configured to engage with one or more opposing clips 80A, 80B, thereby holding the locking mechanism 30 in the open position before interacting with the guide wire stop.

[0106] The protrusion can be sized and configured to extend along any portion and / or length of the receiving portion 74 of the expander bushing 38. For example, the protrusion can be configured to be located within the receiving portion 74 at the distal or proximal end of the expander bushing 38. For example, the expander bushing 38 may include one or more platforms 76A, 76B configured to engage with corresponding clips 80A, 80B. The protrusion can be configured such that a first portion of the locking mechanism 30 (e.g., a first clip 80A) is positioned along a corresponding portion of the protrusion (e.g., a first platform 76A), and a second portion of the locking mechanism 30 (e.g., a second clip 80B) is positioned along a corresponding second portion of the protrusion (e.g., a second platform 76B) to hold the locking mechanism 30 in the open position. When the locking mechanism 230 is initially placed into the receiving portion 74, it can be configured to interlock, engage, or adhere to the protrusion. In some embodiments, the first and second portions of the locking mechanism 30 (e.g., clips 80A, 80B) are capable of adhering at least to a protrusion comprising an adhesive. In some embodiments, the adhesive may extend along the entire inner circumference of the protrusion. The protrusion may be made of a single integral (e.g., an annular ridge) within an expander bushing 38, configured to allow opposing clips 80A, 80B to rest on and / or around one or more platforms 76A, 76B to temporarily hold the locking mechanism 30 in the open position.

[0107] Locking mechanism 30 may include opening 82 (e.g. FIG. 27AAs shown, opening 82 can be sized and configured to selectively allow at least a portion of guidewire 28 to pass through. Opening 82 is chamfered to facilitate insertion of the proximal end of the guidewire through opening 82. As described herein, the inner diameter of opening 82 is large enough to allow a portion of guidewire 28 to be located in and / or pass through opening 28. However, in some embodiments, the inner diameter of opening 82 is not large enough to allow at least another portion of guidewire 28 to pass through opening 282 (e.g., guidewire stop 92B). Therefore, guidewire stop 92B may typically be too large to pass through opening 82, and further proximal movement of guidewire 28 relative to dilator bushing 38 will cause locking mechanism 30 to close. For example, as FIG. 8-FIG. 11 As shown, the guide wire stop 92B can abut against the locking mechanism 30, causing the locking mechanism 30 to move relative to the expander bushing 38 in the proximal direction, thereby disengaging one or more clips 80A, 80B from the protrusions (e.g., one or more platforms 76A, 76B) of the expander bushing 38.

[0108] In some cases, when the locking mechanism 30 changes from the open state to the closed state, the locking mechanism 30 may be arranged around a portion of the guide wire 28, thereby preventing the guide wire 28 from moving beyond the distal end of the expander bushing 38. When the guide wire 28 moves relative to the expander bushing 38 in the proximal direction ( FIG. 27B (As shown), the guidewire stop 92B may abut against and / or engage with the locking mechanism 30. Further distal movement of the guidewire stop 92B relative to the dilator bushing 38 may cause the guidewire stop 92B to disengage the locking mechanism 30 from the protrusion of the dilator bushing 38. Removing the locking mechanism 30 from the protrusion may cause the locking mechanism 30 to transition to a closed state and engage with at least a portion of the guidewire 28 (e.g., as shown). FIG. 27A (As shown). In some cases, once the first clip 80A and / or the second clip 80B of the locking mechanism 30 are removed from the protrusion of the expander bushing 38, they can engage with the guide wire 28 to surround at least a portion of the guide wire 28. As described herein, the locking mechanism 30 can surround the guide wire 28 to prevent the engaged portion of the guide wire 28 from entering beyond the expander bushing 38 in the distal direction. As described herein, the locking mechanism 30 can tend to a closed state such that when the locking mechanism 30 disengages from the protrusion, the locking mechanism 30 automatically transitions to a closed state (e.g., FIG. 27B (As shown).

[0109] Other types of locking mechanisms can also be used to achieve this purpose. For example, but not limited to, an annular bead can be provided within the dilator hub 38 and biased toward a closed configuration. Once the guidewire stops 92A, 92B contact the guidewire lock 44, the bead closes around the guidewire 28. In some cases, the dilator hub 38 can include one or more annular grooves within the receptacle 74 that can prevent the bead and the guidewire 28 from further distal movement when the bead runs into the annular grooves.

[0110] In some embodiments, the locking mechanism 30 can include one or more finger or tang or cam elements to define a guidewire lock 44 or opening configured to allow the guidewire 28 to pass through the locking mechanism 30. The one or more finger elements can extend from a distal end of the locking mechanism 30 toward a proximal end of the locking mechanism 30. The one or more finger elements can allow the guidewire stops 92A, 92B to pass through the guidewire lock 44 or opening in a proximal direction but inhibit the guidewire stops 92A, 92B from passing through the guidewire lock 44 or opening in a distal direction. The guidewire stops 92A, 92B can pass through the opening in the proximal direction by the finger elements. When the guidewire stops 92A, 92B pass, the finger elements can lock into a biased closed position between the guidewire lock 44 or opening and the guidewire stops 92A, 92B. Once the guidewire stops 92A, 92B pass through the opening, the axial movement of the guidewire stops 92A, 92B is inhibited at least in the distal direction and / or substantially irreversibly blocked.

[0111] As with the illustrated embodiment, the degree of bias of the locking mechanism 30 toward the closed state is selected so that the guidewire 28 can slide through the locking mechanism 30 when the locking mechanism 30 is not in contact with the guidewire stops 92. Once the locking mechanism 30 contacts and locks to the guidewire stops 92, the medical practitioner can typically simultaneously withdraw the dilator 24 and the guidewire 28 from the sheath 26 without the risk of the guidewire 28 jamming. As can be appreciated from the description of the above embodiment, the engagement of the locking mechanism 30 with the guidewire 28 and / or the dilator 24 can occur by simple axial movement of the guidewire 28 relative to the dilator hub 38.

[0112] FIG. 27B is a cross-sectional view of the needle 22 penetrating the body 118. FIG. 12A is a cross-sectional view of the distal end of the needle 22. FIG. 2A is a cross-sectional view of the distal end of the needle 22. FIG. 12B is a cross-sectional view of the distal end of the needle 22. FIG. 12A is a cross-sectional view of the distal end of the needle 22. FIG. 13A is a cross-sectional view of the distal end of the needle 22. FIG. 13B is a cross-sectional view of the distal end of the needle 22. In use, the beveled tip 52 enters the blood vessel 122.

[0113] FIG. 13A is a cross-sectional view of the distal end of the needle 22. FIG. 14is a cross-sectional view similar to

[0114] As the guidewire 28 is fed through the needle 22, a guidewire pusher known in the art can be used. For example, if the guidewire 28 has a curved or J-shaped tip, a pusher can be employed to straighten the tip to facilitate entry of the guidewire 28 into the inner bore 54 of the needle 22. FIG. 13A is a cross-sectional view similar to FIG. 15 , except that the guidewire 28 has been extended further into the patient's vasculature.

[0115] FIG. 14 is a cross-sectional view similar to FIG. 16A , except that the needle 22 has been removed and the dilator 24 and sheath 26 have been slid along the exterior of the guidewire 28 until the locking mechanism 30 in the dilator 24 interlocks with the guidewire stops 92A, 92B. FIG. 15 is a partial enlarged cross-sectional view of FIG. 16B . The locking mechanism 30, which is located within the receptacle 74 of the dilator 24, has been effectively slid in a distal direction relative to the guidewire 28 until the locking mechanism 30 interlocks with the guidewire stops 92 on the guidewire 28. The clip 80 of the guidewire lock 44 can engage the lipped surface as shown in the guidewire stops 92A, 92B in FIG. 16A and 7B . Once engaged, the guidewire lock 44 can prevent unwanted slippage or release of the locked portion of the guidewire 28 relative to the locking mechanism 30. The guidewire 28 can substantially carry the locking mechanism 30 and move in unison with the locking mechanism 30. In certain embodiments, the guidewire lock 44 is hinged to provide a bias toward the center of the dilator hub 38 that can prevent the locked portion of the guidewire 28 from slipping or disengaging from the guidewire lock 44.

[0116] In some embodiments, the locking mechanism 30 can be oppositely oriented within the dilator hub 38. For example, FIG. 7A is a partial enlarged cross-sectional view similar to FIG. 16C , except that the opposing clip 80 of the locking mechanism 30 (as described herein) is located in a proximal direction from the opening 82 of the locking mechanism 30. When in the opposite orientation (as shown in FIG. 16BWhen the locking mechanism 30 is in the locked position (as shown), the locking mechanism 30 can function in the same manner as described herein; however, the guidewire 28 and the guidewire stops 92A, 92B can pass through the openings 82 prior to passing through or engaging the opposing clip 80, respectively. In such embodiments, the guidewire stops 92A, 92B and the openings 82 can be sized and configured to allow the guidewire stops 92A, 92B to pass through the openings 82. To further facilitate insertion of the guidewire proximal end through the openings 82, the distal side of the openings 82 can be provided with a chamfer.

[0117] FIG. 16C is a cross-sectional view similar to FIG. 17 where the dilator 24 and the sheath 26 have been further slid along the exterior of the guidewire 28 and into the patient's vasculature, spacing the dilator 24 from the locking mechanism 30. During passage of the sheath 26 and the dilator 24 over the guidewire 28 into the blood vessel 122, the guidewire 28 is free to slide through the locking mechanism 30 until the guidewire lock 44 interlocks with the guidewire stops 92A, 92B. Once interlocked, the guidewire 28 and the locking mechanism 30 can move in unison. In this configuration, the guidewire 28 is prevented from being pulled out of the distal end of the dilator 24 and lost within the patient in the distal direction.

[0118] FIG. 16A is a cross-sectional view similar to FIG. 18 where the guidewire 28 and the locking mechanism 30 interlocked therewith have been withdrawn from the dilator 24 and the sheath 26. In certain embodiments, the medical professional instead withdraws the dilator 24 until the locking mechanism 30 comes into contact with or interlocks with the dilator 24. Prior to removal of the guidewire 28, the locking mechanism 30 can interlock with the dilator 24 by abutting against the wall 58. Thus, further withdrawal of the dilator 24 also withdraws the locking mechanism 30 and the guidewire 28 from the sheath 26.

[0119] FIG. 17 is a cross-sectional view similar to FIG. 19 where the dilator 24 has been removed from the patient and the sheath 26. The sheath 26 is left properly inserted within the blood vessel 122. The dilator 24 can be removed after or together with the guidewire 28.

[0120] FIG. 18 is a cross-sectional view similar to FIG. 20 where the catheter 120 is aligned with the sheath 26 for insertion into the patient's vasculature. FIG. 19 is a cross-sectional view similar to FIG. 21 where the catheter 120 has been inserted into the patient's vasculature through the sheath 26, specifically the target blood vessel 122.

[0121] FIG. 20 is a cross-sectional view similar to FIG. 21FIG. 6 is a cross-sectional view of the sheath 26 with the two portions of the sheath 26 peeled away from each other so that the sheath 26 no longer encloses the catheter 120. The sheath 26 can be split along one or more split lines. The splitable sheath 26 provides the advantage that depending on the type of catheter or medical article that is inserted into the blood vessel after use of the access device 20, a portion or the entirety of the sheath body 40 can be removed. For example, after the catheter 120 is inserted into the blood vessel 122, a portion of the sheath body 40 is separated or peeled away and removed to reduce clutter at the access site. The peeled away sheath 26 can first be slid in the proximal direction along the catheter 120 until the sheath 26 is removed from the patient and then split apart. Alternatively, the sheath 26 can be split apart before the entire sheath 26 is removed from the patient. After the remaining portion of the sheath 26 is removed from the patient, the physician or medical staff can continue to disassemble the sheath 26. Of course, as shown in FIG. 6, the sheath 26 can be disassembled at the same time as it is removed from the patient. In certain embodiments, the sheath 26 is not disassemblable. FIG. 20

[0122] According to some embodiments, FIG. 22 are various views of the locking mechanism in engagement with the guidewire 28. In particular, FIG. 23A-24B is an elevational view of one embodiment of the locking mechanism 130, FIG. 23A and 23C are rear and side cross-sectional views, respectively, of the locking mechanism 130. FIG. 23B and FIG. 24A are cross-sectional views of one embodiment of a method of engaging the locking mechanism 130 with the guidewire 28 including the guidewire stop 92B. Unless otherwise noted, FIG. 24B the locking mechanism 130 shown in FIGS. 1-5 can include the same or substantially similar components as those identified by like reference numerals in the remaining figures discussed herein. It can be appreciated that FIG. 23A-24B the features of the locking mechanism 130 shown in FIGS. 1-5 can be used with any embodiment described and / or contemplated herein. It should also be appreciated that any feature, structure, material, step, or component of any embodiment described and / or shown herein can be used in place of or with any other feature, structure, material, step, or component of the locking mechanism 130 shown in FIGS. 1-5. FIG. 23A-24B the locking mechanism 130 shown in FIGS. 1-5. FIG. 23A-24B the locking mechanism 130 shown in FIGS. 1-5.

[0123] ​As shown in the embodiments described, the locking mechanism 130 may include a sphere having an outer wall 132. The locking mechanism 130 may be hollow to accommodate at least a portion of the guidewire 28 within the inner cavity 134 of the locking mechanism. In some embodiments, the locking mechanism 130 may include one or more openings. A user may utilize one or more openings to allow the guidewire 28 to pass through the locking mechanism 130 and engage the guidewire stop 92B within the inner cavity 134 to prevent accidental removal of the locking mechanism 130 from the guidewire 28. In some embodiments, the locking mechanism 130 may include an elastic material and / or a flexible structure such that the elastic material and / or flexible structure can slightly deform when the guidewire stop 92B passes through one or more openings of the locking mechanism 130.

[0124] As described herein, the first opening can serve as a guide wire lock 144. The second opening 182 allows a portion of the guide wire 28 near the guide wire stop 92B to pass through and / or exit the cavity 134 of the locking mechanism 130, while still retaining a portion of the guide wire 28 (e.g., the guide wire stop 92B) within the cavity 134. FIG. 23A-24B As shown, the opening can be located on the opposite side of the outer wall 132.

[0125] In some embodiments, the first opening or locking element 144 may be located at the distal end of the locking mechanism 130. The opening of the locking element 144 along the entire outer wall 132 of the locking mechanism 130 may not include a constant diameter (e.g., FIG. 23C-24B (As shown). For example, locking element 144 may include an external opening 146 and an internal opening 148 with a different diameter extending through the outer wall 132. In some embodiments, the diameter of the external opening 146 of locking element 144 may be larger than the diameter of the internal opening 148. Thus, locking element 144 may be tapered toward the internal opening 148. The tapering may advantageously allow guidewire stop 92B to pass through locking element 144 and enter cavity 134 only in the proximal direction, and once guidewire stop 92B enters cavity 144, prevents guidewire stop 92B from passing through locking element 144 in the distal direction. Locking element 144 may include any suitable shape and configuration capable of receiving and / or engaging guidewire stop 92B. For example, as FIG. 23C As shown, the locking element 144 may include a generally conical shape, but it should be understood that the locking element 144 may include any suitable wall structure (e.g., straight and / or curved) and have any suitable shape (e.g., cylindrical, conical).

[0126] like FIG. 23C to FIG. 24B and 24BAs shown, the diameter of the external opening 146 may be larger than the diameter of the guidewire 28 (e.g., including the guidewire stop 92B), but the diameter of the internal opening 148 may be at least smaller than the diameter of the guidewire stop 92B. In some cases, the diameter of the internal opening 148 may be smaller than the external width or diameter of the guidewire stop 92B, but should be large enough that the outer wall 132 defining the internal opening 148 temporarily elastically or flexibly increases in size to allow the guidewire stop 92B to pass through the internal opening 148 in the proximal direction and enter the cavity 134, while preventing the guidewire stop 92B from being removed from the cavity 134 in the distal direction once inserted.

[0127] like FIG. 24A As shown, in some embodiments, the second opening 182 and the internal opening 148 each include an inner diameter smaller than the outer width of the outer surface of the guidewire stop 92B to prevent accidental removal of the guidewire stop 92B from the proximal and / or distal end of the lumen 134. Therefore, the second opening 182 and the internal opening 148 can be sized to allow a portion of the guidewire 28 located at the distal and / or proximal end of the guidewire stop 92B to extend outside the lumen 134, while the guidewire stop 92B remains inside the lumen 134.

[0128] Locking element 144 may include any suitable shape and / or configuration that allows guide wire stop 92B to enter the cavity 134 of locking mechanism 130 while preventing guide wire stop 92B from being removed from the cavity 134. Outer wall 132 may include any material suitable for allowing engagement with guide wire 28 without causing locking mechanism 130 to tear or be irreversibly stretched or otherwise damaged as guide wire stop 92B passes through internal opening 148. In some embodiments, to prevent accidental disengagement of locking mechanism 130 from guide wire stop, locking mechanism 130 may include a semi-rigid, restorative, or elastic material that is slightly deformable when force is applied. When guide wire stop 92B is inserted into cavity 134, internal opening 148 is configured to deform axially outward or in an opening direction substantially perpendicular to the longitudinal axis of guide wire stop 92B. In some embodiments, internal opening 148 is configured to, after guide wire stop 92B is inserted into cavity 134 (e.g., FIG. 24B As shown in the diagram, it springs radially inward in a closing direction generally opposite to the opening. This advantageously allows the internal opening 148 of the locking element 144 to temporarily and / or permanently retain the guide wire stop 92B within the cavity 134.

[0129] According to some embodiments, FIG. 24B These are various views of another locking mechanism that engages with guide wire 28. In particular, FIG. 25A-26B This is a front view of one embodiment of the locking mechanism 230. FIG. 25A This is a side sectional view of the locking mechanism 230. FIG. 25Band 26B is a side cross-sectional view of an embodiment of the method by which the locking mechanism 230 engages with the guidewire 28 having a guidewire stop 92B. Unless otherwise noted, FIG. 26A The locking mechanism 230 shown can include components that are the same as or substantially similar to components identified by like reference numerals in the remaining figures discussed herein. It can be appreciated that, FIG. 25A-26B The features of the locking mechanism 230 shown can be used with any embodiment described and / or contemplated herein. It should also be appreciated that any feature, structure, material, step, or component of any embodiment described and / or shown herein can be used with or instead of FIG. 25A-26B any other feature, structure, material, step, or component of the locking mechanism 230 shown. FIG. 25A-26B any other feature, structure, material, step, or component of the locking mechanism 230 shown.

[0130] As FIG. 25A-26B and 26B shown, the locking mechanism 230 shown can include a sheath or disc configured to interact with at least a portion of the guidewire 28 (e.g., the guidewire stop 92B). As described herein, the locking mechanism 230 can be folded, wrapped, or otherwise positioned over or around the guidewire 28 to enclose at least a portion of the guidewire stop 92B, or otherwise interact with the guidewire stop 92B to prevent the locking mechanism 230 and the guidewire stop 92A from moving distally beyond the dilator hub 38 (e.g., into the dilator shaft).

[0131] The locking mechanism 230 can be made from a single unitary body that can fold, be folded, be wrapped, or otherwise automatically position itself over or around the dilator hub 38 and / or the guidewire 28 to prevent undesired distal movement of the guidewire 28 relative to the dilator hub 38. As FIG. 26A and 26B shown, the locking mechanism 230 can have a first configuration positioned at the proximal end portion 72 of the dilator hub 38 and a second configuration positioned on and engaged with the guidewire 26.

[0132] As FIG. 26AAs shown, when the locking mechanism has the first configuration, the locking mechanism 230 can be arranged on the proximal portion 72 of the expander bushing 38. The locking mechanism 230 can be sized and configured to extend and surround any portion and / or length of the receiving portion 74 of the expander bushing 38. For example, the locking mechanism 230 is configured to be positioned on the proximal end of the proximal portion 72 of the expander bushing 38 and surround the receiving portion 74. The locking mechanism 230 is configured such that a first portion 244a of the locking mechanism is arranged along a corresponding first portion of the expander bushing 38, and a second portion 244b of the locking mechanism 230 is arranged along a corresponding second portion of the expander bushing 38 to substantially surround the receiving portion 74. The locking mechanism 230 is configured to adhere to the expander bushing 32 when placed. In some embodiments, the first portion 244a and the second portion 244b of the locking mechanism 230 are capable of adhering to at least the expander bushing 38 along an adhesive-containing joint. In some embodiments, the engaging portion may extend along the entire outer periphery of the locking mechanism 230.

[0133] The locking mechanism 230 may include an opening 282, which is sized and configured to selectively allow at least a portion of the guidewire 28 to pass through. As described herein, the inner diameter of the opening 282 may be large enough to allow a portion of the guidewire 28 to reside within and / or pass through the opening 282. However, the inner diameter of the opening 282 may not be large enough to allow at least another portion of the guidewire 28 (e.g., guidewire stop 92B) to pass through the opening 282. FIG. 26A As shown, the guide wire stop 92B may be too large to pass through the opening 282, and further proximal movement of the guide wire 28 relative to the dilator bushing 38 will remove the locking mechanism 230 from the dilator bushing 38 in the proximal direction to disengage the locking mechanism 230 from the dilator bushing 38.

[0134] In some cases, when the locking mechanism 230 is in the second configuration, the locking mechanism 230 can be arranged around the guide wire stop 92B, thereby preventing the guide wire stop 92B from moving distally beyond the expander bushing 38. This is when the guide wire 28 moves proximally relative to the expander bushing 38 ( FIG. 26B (As shown), the guidewire stop 92B may abut against and / or engage with the locking mechanism 230. Further distal movement of the guidewire stop 92B relative to the dilator bushing 38 may cause the guidewire stop 92B to peel off and / or cause the locking mechanism 230 to disengage from the dilator bushing 38. Removal of the locking mechanism 30 from the dilator bushing 38 may cause the locking mechanism 230 to fold over the guidewire stop 92B (as shown). FIG. 26AIn some cases, once the first portion 244a and / or the second portion 244b of the locking mechanism 230 is removed from the dilator hub 38, the guidewire 28 can be adhered and / or engaged to enclose at least a portion of the guidewire stop 92B. As described herein, the locking mechanism 230 can enclose the guidewire stop 92B to prevent entry of the guidewire stop 92B beyond the dilator hub 38 in a distal direction beyond the dilator hub 38. The locking mechanism 230 can be folded in a lateral and / or longitudinal direction to cover the guidewire stop 92B.

[0135] In some embodiments, when the locking mechanism 230 is in the second configuration (as shown), it can be formed by folding, wrapping, enclosing, or crimping the locking mechanism 230 around or on at least a portion of the guidewire 28 to cover at least the guidewire stop 92B. The first portion 244a and / or the second portion 244b are configured to engage and / or adhere to a portion of the locking mechanism 230 itself and / or any portion of the guidewire 28. FIG. 26B

[0136] The locking mechanism 230 can be circular (as shown), square, rectangular, oval, or any other suitable size and / or shape to enclose and / or form a radial extension from a portion of the guidewire. To facilitate manufacturing and assembly, the locking mechanism 230 can initially be substantially flat. The locking mechanism 230 can be made from a variety of flexible or semi-rigid materials, such as a polyester film or sheet, a plastic sheet or film, or PET (polyethylene terephthalate). For example, the locking mechanism 230 can include a polyester film. As described herein, the locking mechanism 230 can be formed by adhering a plastic sheet or film to the dilator hub 38.

[0137] FIG. 26B are various views of a locking mechanism for engaging with a guidewire 28 according to some embodiments. Specifically, FIG. 28A-29B is a front view of a locking mechanism 330 of an embodiment, FIG. 28A and 28C are a back cutaway view and a side cutaway view, respectively, of the locking mechanism 330. FIG. 28B and 29B are side cutaway views of embodiments of a method of the locking mechanism 330 engaging with a guidewire 28 having a guidewire stop 92B. Unless otherwise noted, FIG. 29A The locking mechanism 330 shown in 28A-29B can include the same or substantially similar components as those identified by like reference numbers in the remaining figures discussed herein. It can be appreciated that the features of the locking mechanism 330 shown in 28A-29B can be used with any embodiment described and / or contemplated herein. It should also be appreciated that any feature, structure, material, step, or component of any embodiment described and / or shown herein can be used with FIG. 28A-29B ​​The locking mechanism 330 shown may be used in conjunction with or in place of any other features, structure, material, step, or component. FIG. 28A-29B Any other features, structure, material, steps, or components of the locking mechanism 330 shown.

[0138] As shown in the illustrated embodiment, the locking mechanism 330 may include a cylinder having an outer wall 332. The illustrated locking mechanism 330 may be substantially hollow to accommodate at least a portion of the guide wire 28 within a cavity 334 of the locking mechanism 330. In some embodiments, the locking mechanism 330 may include one or more openings. A user may utilize one or more openings to allow at least a portion of the guide wire 28 to pass through the locking mechanism 330. A first opening 346 may allow at least a portion of the guide wire 28 into the cavity 334 of the locking mechanism 330. A second opening 382 enables a portion of the guide wire 28 near the guide wire stop 92B to pass through and / or exit the cavity 334 of the locking mechanism 330, while still retaining a portion of the guide wire 28 (e.g., the guide wire stop 92B) within the cavity 334. FIG. 28A-29B As shown, the opening can be located on the opposite side of the outer wall 132.

[0139] The locking mechanism 330 may include a locking element 344 to engage with the guide wire stop 92B within the cavity 334 and prevent the locking mechanism 330 from being accidentally removed from the guide wire 28. FIG. 28C-29B As shown, in some embodiments, the locking element 344 may comprise an adhesive, elastic, and / or gel-like material (e.g., silicone or acrylic gel) capable of interacting with and / or interlocking with at least a portion of the guidewire 28 (e.g., guidewire stop 92B). As described herein, the locking mechanism 330 may adhere to, attach to, engage with, or otherwise interact with at least a portion of the guidewire stop 92B (e.g., around or enclose the mold) to prevent the locking mechanism 330 and the guidewire stop 92B from moving in the distal direction beyond the expander bushing 38 (e.g., into the expander shaft).

[0140] The locking element 344 may be made of a single integral component disposed within the cavity 334 of the locking mechanism 330 to prevent unintended distal movement of the guidewire 28 relative to the dilator bushing 38. In some embodiments, the locking element 344 may be arranged at least along the proximal end of the cavity 334. As shown in the illustrated embodiment, the locking element 344 may include a generally cylindrical shape, which may be generally hollow to accommodate at least a portion of the guidewire 28 within the locking element 344. In some embodiments, the locking element 344 may include one or more element openings. A user may utilize the one or more element openings to allow at least a portion of the guidewire 28 to pass through the locking element 344.

[0141] In some embodiments, an internal channel defined by the inner wall 345 of the element extends through the locking element 344. The inner wall 345 of the locking element 144 may not include an inner diameter that remains constant along the entire length of the inner wall 345 of the locking element 344 (e.g., FIG. 29B (As shown). For example, locking element 344 may include a first element opening 346 and a second element opening 348 with different diameters located at opposite ends (e.g., distal and proximal ends, respectively) of inner wall 345. In some embodiments, the diameter of the first element opening 346 of locking element 344 may be larger than the diameter of the second element opening 348 of locking element 144. Thus, inner wall 345 may be tapered toward the smaller diameter of the second element opening 348. As described herein, the tapering can advantageously facilitate at least a portion of guidewire 28 through locking element 344 in the proximal direction, while preventing guidewire stop 92B from passing through locking element 344 in the distal direction once guidewire stop 92B is interlocked with locking element 344. For example, the tapering of inner wall 345 may facilitate guiding (e.g., converging) the proximal end of guidewire 28 through locking mechanism 330.

[0142] like FIG. 28C-29B and 29B As shown, the diameter of the first element opening 346 can be larger than the diameter of the guide wire 28 (e.g., including the guide wire stop 92B), but the diameter of the second element opening 348 can be smaller than at least the guide wire stop 92B. In some cases, the diameter of the second element opening 348 can be smaller than the outer width or diameter of the guide wire stop 92B, such that when the guide wire stop 92B passes through the locking element 344, the tapered inner wall 345 facing the second element opening 348 can engage with the guide wire stop 92B (e.g., when the guide wire stop 92B passes through the locking element 344). FIG. 29A (As shown).

[0143] The second element opening 348 may have a similar size to the opening 382, ​​such that the second element opening 348 allows a portion of the guide wire 28 near the guide wire stop 92B to pass through and / or exit the cavity 334 of the locking mechanism 330, while still retaining a portion of the guide wire 28 (e.g., the guide wire stop 92B) within the cavity 334. The second element opening 348 may be coaxially aligned with the opening 382.

[0144] The locking element 344 may include any suitable shape and configuration capable of receiving and / or engaging with the guidewire stop 92B to prevent the guidewire stop 92B from being removed from the locking element 344 in the distal direction once inserted. For example, as FIG. 29BAs shown, the locking element 344 can include a generally cylindrical shape, although it is appreciated that the locking element 344 can include any suitable wall structure (e.g., straight and / or curved) and have any suitable shape (e.g., cylindrical, rectangular, tapered). In some embodiments, the locking element 344 can be configured to temporarily elastically or flexibly increase in size to allow the guidewire stop 92B to continue to pass through the locking element 344 in the proximal direction once the guidewire stop 92B initially engages the locking element 344. In certain instances, the locking element 344 can be made of a variety of flexible or semi-rigid materials having adhesive-like properties, such as silicone. The locking element 344 can be formed by adhering an adhesive substance within the inner lumen 334 of the locking mechanism 330.

[0145] In some instances, the locking element 344 can not have sufficient engagement and / or adhesion forces to engage with the guidewire 28 when the guidewire 28 is initially passed through the locking element 344. In certain embodiments, the adhesion of the locking element 344 on the guidewire 28 is not sufficient to prevent the guidewire 28 from moving relative to the locking mechanism 330. The adhesion of the locking element 344 on the guidewire 28 can still allow the guidewire 28 to move relatively freely (e.g., with minimal resistance) relative to the locking element 344 until the locking element 344 interlocks or engages with the guidewire stop 92B. For example, the locking element 344 can not be sufficient to stop the guidewire 28 from passing through the locking element 344 before the locking element 344 engages with the guidewire stop 92B. Once the locking element 344 engages with the guidewire stop 92B, the locking element 344 stops at least further distal movement of the guidewire 28 relative to the locking element 344.

[0146] As FIG. 28A-29BAs shown, the locking mechanism 330 can be disposed within the receptacle 74 of the dilator hub 38. The locking mechanism 330 can be sized and configured to extend along and encompass any portion and / or length of the receptacle 74. The locking mechanism 330 can be disposed within the dilator hub 32 by any of the mechanisms described herein. The locking mechanism 330 can be removably engaged with at least a portion of the dilator hub 38 such that, once the locking mechanism 330 is interlocked with the guidewire 28, the locking mechanism 330 can be moved into or out of the receptacle 74 as the dilator hub 38 is slid in either the proximal or distal direction along the guidewire 28, respectively. For example, the locking mechanism 330 can be removably retained within the receptacle 74 by any suitable interaction (e.g., interference, engagement, friction, mechanical coupling, adhesion, etc.). In certain embodiments, once the locking mechanism 330 is interlocked with the guidewire 28, the guidewire 28 and the locking mechanism 330 move in unison during removal of the guidewire 28. For example, once the locking mechanism 330 is interlocked with the guidewire 28, further proximal movement of the guidewire 28 relative to the dilator 24 can be sufficient to overcome the interaction that removably retains the locking mechanism 330 within the receptacle 74.

[0147] As described, the inner diameter of the second element opening 348 can be large enough to allow a portion of the guidewire 28 to reside within and / or pass through the second element opening 348. However, the inner diameter of the second element opening 348 is not large enough to allow at least another portion of the guidewire 28 to pass through the second element opening 348 (e.g., the guidewire stop 92B). As shown, FIG. 29A As shown, as such, the guidewire stop 92B can be too large to pass through the second element opening 348, further proximal movement of the guidewire 28 relative to the dilator hub 38 will cause the locking mechanism 330 to engage at least a portion of the guidewire 28 (e.g., the increased width of the guidewire stop 92B) to interlock the locking mechanism 330 with the guidewire 28.

[0148] When the guidewire stop 92B is engaged with the locking mechanism 330, the locking element 344 is attached to the guidewire stop 92B such that the locking mechanism 330 prevents the guidewire stop 92B from moving distally beyond the dilator hub 38. When the guidewire 28 is moved in the proximal direction relative to the dilator hub 38 (as shown), FIG. 29B FIG. 29A As shown, the guidewire stop 92B can abut and / or engage the locking element 344. The locking element 344 can engage the guidewire stop 92B to prevent the guidewire stop 92B from moving distally beyond the dilator hub 38.

[0149] The embodiments described herein include conventional biocompatible materials. For example, preferably, the needle includes a ceramic, a rigid polymer, or a metal such as stainless steel, nickel-titanium alloy, or the like. Other components can be formed of suitable polymeric materials, such as polycarbonates, nylons, polyethylenes, high-density polyethylenes, polypropylenes, fluoropolymers and copolymers, such as perfluoro(ethylene-propylene) copolymers, polyurethane polymers or copolymers.

[0150] As noted above, the present access device can be used to place catheters at other locations within a patient's body. Thus, for example and without limitation, the access device can be used as or with a variety of catheters to drain fluid from abscesses, to drain air from pneumothorax, and to access the peritoneal cavity.

[0151] While the application has been disclosed by certain preferred embodiments and examples, it will be understood by those skilled in the art that the application extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the application and obvious modifications and equivalents thereof. Further, it is intended that each definition in the specification be understood as a means for providing equivalents. Moreover, while numerous embodiments of the application have been described in detail, those skilled in the art will understand that the application can be implemented in other specific forms without departing from the spirit or essential character thereof. Also, it is contemplated that various combinations or sub-combinations of specific features and aspects of embodiments can be made and still fall within the scope of the application. Accordingly, the disclosed embodiments are to be considered as illustrative and not restrictive, and the scope of the application is to be determined not with reference to the above description, but instead is to be determined with reference to the appended claims, along with their full scope of equivalents.

Claims

1. A access device for placing a medical article within a body space, the access device comprising: An expander having a bushing and an elongated expander body extending from the bushing; A guidewire configured to slide within the elongated expander body and having a guidewire stop that is accommodable by the elongated expander body; as well as A locking mechanism, removably engaged with and supported by the expander before the expander is inserted into the guidewire, includes a guidewire lock and an opening extending therethrough, the size and shape of which are configured to receive the guidewire and prevent the guidewire stop from passing through the opening. The locking mechanism is configured to interlock with the guidewire at least when the expander is inserted into the guidewire via an interaction between the guidewire lock and the guidewire. The guidewire lock has a pair of opposing components configured to be biased into a closed state to interlock with the guidewire stop. When the expander is fully inserted into the guidewire, the locking mechanism interacts with the guidewire. The locking mechanism and the expander are also configured to allow the locking mechanism to be removed from the expander by axially moving the guidewire relative to the proximal end of the expander.

2. The passage device of claim 1, wherein the expander is sized and shaped relative to the locking mechanism to prevent the locking mechanism from passing completely through the expander in the distal direction.

3. The access device of claim 2, wherein the expander includes a receiving portion for receiving the locking mechanism, the receiving portion including an abutting surface configured to prevent the locking mechanism from moving relative to the expander in a distal direction.

4. The access device according to claim 1, wherein the guide wire stop is a groove disposed in the guide wire.

5. The passage device according to claim 4, wherein the groove is annular.

6. The access device according to claim 1, wherein the guide wire stop is a notch disposed in the guide wire.

7. The access device of claim 1, wherein the guidewire is tapered at least a portion of its length, the portion being located at the guidewire stop.

8. The access device of claim 1, wherein the locking mechanism interlocks with the guidewire at a location on the proximal side of at least a portion of the dilator.

9. The access device of claim 8, wherein the guidewire lock is sized and shaped to allow the guidewire to move in the proximal direction through the locking mechanism until the guidewire stop contacts the guidewire lock and the guidewire lock closes around the guidewire.

10. The access device of claim 9, wherein when the guidewire lock engages with the guidewire stop, the locking mechanism inhibits at least further distal movement of the guidewire relative to the locking mechanism.

11. The access device of claim 1, wherein the guidewire lock comprises one or more tabs configured to engage with the guidewire stop.

12. The access device according to claim 1, wherein the locking mechanism comprises metal.

13. The access device according to claim 1, wherein the locking mechanism comprises plastic.

14. The passage device according to claim 1, wherein the locking mechanism has an annular shape.

15. The passage device according to claim 1, wherein the side view of the locking mechanism has a V-shape.

16. The access device of claim 1, further comprising a sheath disposed around the expander.

17. The passage device according to claim 1, wherein the locking mechanism is disposed in the bushing.

18. The access device of claim 1, wherein the locking mechanism comprises a sheath configured to be placed on at least a portion of the sheath of the dilator before the dilator is inserted into the guidewire, wherein, The sheath is also configured to surround at least a portion of the guidewire stop when the locking mechanism is interlocked with the guidewire.

19. The access device according to claim 1, wherein the locking mechanism comprises: The outer wall of the defined lumen is configured to accommodate at least a portion of the guidewire; as well as A locking element, the locking element being configured to be at least partially disposed within the cavity. The locking mechanism is configured to be located within the bushing of the expander before the expander passes through the guide wire, wherein when the locking mechanism is interlocked with the guide wire, the locking element is also configured to engage at least a portion of the guide wire stop.

20. A access device for placing a medical article within a body space, the access device comprising: Guide wire with guide wire stop; An expander configured to be coaxially disposed around the guidewire; as well as A locking mechanism removably engaged with and disposed on the expander prior to its coaxial placement around the guidewire, the locking mechanism having an opening sized and shaped to receive the guidewire and prevent the guidewire stop from passing through the opening, the locking mechanism being configured to move from an unlocked state to a locked state; when the locking mechanism is in the unlocked state, the locking mechanism is not engaged with the guidewire to allow axial movement of the guidewire through the locking mechanism in the proximal and distal directions relative to the expander; when the locking mechanism is in the locked state, the locking mechanism is engaged with the guidewire to restrict at least axial movement of a portion of the guidewire in the distal direction relative to at least a portion of the expander; the locking mechanism includes a pair of opposing components movable between the locked and unlocked states, the components being configured to bias towards a closed configuration to interlock with the guidewire when the expander is fully inserted into the guidewire; the locking mechanism and the expander are also configured to allow the locking mechanism to be removed from the expander by axially moving the guidewire in the proximal direction relative to the expander.

21. The access device of claim 20, wherein at least axial movement of the portion of the guidewire in the distal direction is inhibited by contact between the locking mechanism and the expander.

22. The access device of claim 20, wherein the guide wire stop is accommodated by the expander.

23. The access device of claim 20, wherein the expander is sized and shaped relative to the locking mechanism to prevent the locking mechanism from passing completely through the expander in the distal direction.

24. The access device according to claim 20, wherein the guide wire stop is a groove disposed in the guide wire.

25. The access device of claim 20, wherein the locking mechanism engages with the guidewire at a location on the proximal side of at least a portion of the dilator.

26. The access device of claim 20, wherein the locking mechanism comprises a guidewire lock configured to engage with the guidewire stop.

27. The passage device according to claim 20, wherein the locking mechanism has an annular shape.

28. The access device according to claim 20, wherein the side view of the locking mechanism has a V-shape.

29. The access device of claim 20, wherein the locking mechanism comprises a sheath configured to rest on at least a portion of the bushing of the expander when the locking mechanism is in an unlocked state, and wherein, The sheath is also configured to surround at least a portion of the guidewire stop when the locking mechanism is in the locked state.

30. The access device according to claim 20, wherein the locking mechanism comprises: The outer wall of the defined lumen is configured to accommodate at least a portion of the guidewire; as well as A locking element, the locking element being configured to be at least partially disposed within the cavity. Wherein, when the locking mechanism is in the unlocked state, the locking mechanism is configured to be located within the bushing of the expander, and wherein, when the locking mechanism is in the locked state, the locking element is further configured to engage with at least a portion of the guide wire stop.

Images