Guidewire introducer and shaper

Abstract

A medical device (100) includes: a tubular structure (110) having a first end (112), a second end (114), and a body (116) extending between the first end and the second end; wherein the first end of the tubular structure is configured to detachably couple to a distal end (202) of a guidewire delivery device (200); wherein the second end of the tubular structure is distal to the first end of the tubular structure, and wherein the second end of the tubular structure has an opening (120) that is larger than an introducer opening (210) at the distal end of the guidewire delivery device; and wherein the tubular structure comprises a lumen (140) extending between the first end and the second end, wherein at least a part of the lumen has a tapered configuration.

Description

Attorney Docket: 22-032 PCTGUIDEWIRE INTRODUCER AND SHAPERFIELD

[0001] The field of the application relates to medical devices, and more specifically, to guidewire insertion and shaping tools, medical devices having such guidewire insertion and shaping tools, and the methods of using guidewire insertion and shaping tools.BACKGROUND

[0002] Physicians frequently use a shaped guidewire for procedures. For example, delivery of an intravascular implant (such as a stent, stent graft, flow-diverter, aneurysm occlusive device, vena cava filter, etc.) may require use of a guidewire that is inserted into the vascular system of the patient. The distal end of the guidewire may have a bent configuration, which allows navigation through the vasculature to a targeted implantation site.

[0003] In certain applications, such as in the neurovascular space, the guidewires may be required to navigate tortuous and intricate vasculature, including traveling within relatively fragile blood vessels in the brain, and are often required to change direction.

[0004] Commonly used vascular application to access a target site in a patient involves inserting a guidewire through an incision in the femoral artery near the groin, and advancing the guidewire until it reaches the target site. Then, an implant-delivery catheter is advanced over the guidewire until an open distal end of the catheter is disposed at the target site. Simultaneously or after placement of the distal end of the catheter at the target site, an intravascular implant is advanced through the catheter via a push or delivery wire.

[0005] The shaped guidewire may be pre-shaped by a manufacturer of the guidewire, or may be shaped by a physician. There are challenges associated with introducing a shaped guidewire into a catheter, such as a micro catheter.

[0006] One current technique of introducing a shaped guidewire into a catheter requires trying to get the shaped guidewire to go into a tunneled catheter hub. However, such technique may be unsuccessful, or it may cause physician to feel frustrated because getting the shaped guidewire to go into the tunneled catheter hub may be difficult and time-consuming.Attorney Docket: 22-032 PCT

[0007] Another current technique of introducing a shaped guidewire into a catheter requires backloading a guidewire introducer from the back end of the guidewire, and pulling the guidewire relative to a guidewire introducer until the guidewire introducer reaches the distal segment of the guidewire. However, such technique is time consuming, and may damage the coating on the guidewire as the guidewire is pulled relative to the guidewire introducer through a majority of the length of the guidewire.

[0008] Also, during a procedure, a guidewire may be required to be removed from the catheter, and may be required to be re-introduced into the catheter through a catheter hub, for one or multiple times (e.g., to re-shape the guidewire, and / or to deliver a device). Each time the guidewire needs to be introduced into the catheter via the catheter hub, the above technical problems would arise. Accordingly, the above technical problems may occur multiple times during a procedure — thus, lengthening procedure time.SUMMARY

[0009] A medical device includes: a tubular structure having a first end, a second end, and a body extending between the first end and the second end; wherein the first end of the tubular structure is configured to detachably couple to a distal end of a guidewire delivery device; wherein the second end of the tubular structure is distal to the first end of the tubular structure, and wherein the second end of the tubular structure has an opening that is larger than an introducer opening at the distal end of the guidewire delivery device; and wherein the tubular structure comprises a lumen extending between the first end and the second end, wherein at least a part of the lumen has a tapered configuration.

[0010] Optionally, the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0011] Optionally, the tubular structure comprises a wall, and wherein a part of the wall of the tubular structure is configured to extend over an outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.Attorney Docket: 22-032 PCT

[0012] Optionally, the part of the wall that is configured to extend over the outer surface of the guidewire delivery device extends along a majority of a longitudinal length of the tubular structure.

[0013] Optionally, the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.

[0014] Optionally, the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allow the second end of the tubular structure to abut against an inner surface of the catheter hub.

[0015] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

[0016] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is nonperpendicular with respect to an interior surface of the wall.

[0017] Optionally, the tubular structure has a funnel shape.

[0018] Optionally, the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.

[0019] Optionally, a majority of a longitudinal side of the tubular structure has a rectilinear profile.

[0020] Optionally, a majority of a longitudinal side of the tubular structure has a curvilinear profile.

[0021] Optionally, the medical device further includes a locking mechanism configured to lock the tubular structure with respect to the guidewire delivery device.

[0022] Optionally, the tubular structure is made from a polymer.

[0023] Optionally, the second end of the tubular structure is configured to shape a guidewire in response to application of force applied to the guidewire to urge the guidewire against the second end of the tubular structure.

[0024] Optionally, the part of the lumen having the tapered configuration is a majority part of the lumen.Attorney Docket: 22-032 PCT

[0025] Optionally, the part of the lumen having the tapered configuration is a minority part of the lumen at a location that is closer to the second end of the tubular structure than to the first end of the tubular structure.

[0026] A medical device includes: a tubular structure having a first end, a second end, and a body extending between the first end and the second end; wherein the first end of the tubular structure is configured to detachably couple to a distal end of a guidewire delivery device; wherein the second end of the tubular structure is distal to the first end of the tubular structure, and wherein the second end of the tubular structure has an opening that is larger than an introducer opening at the distal end of the guidewire delivery device; wherein the tubular structure comprises a lumen extending between the first end and the second end; and wherein the tubular structure has a wall with an exterior surface, and wherein a majority of a longitudinal side of the exterior surface of the tubular structure is parallel to a longitudinal axis of the tubular structure.

[0027] Optionally, the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0028] Optionally, the tubular structure comprises a wall, and wherein a part of the wall of the tubular structure is configured to extend over an outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0029] Optionally, the part of the wall that is configured to extend over the outer surface of the guidewire delivery device extends along a majority of a longitudinal length of the tubular structure.

[0030] Optionally, the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.

[0031] Optionally, the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allow the second end of the tubular structure to abut against an inner surface of the catheter hub.Attorney Docket: 22-032 PCT

[0032] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

[0033] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is nonperpendicular with respect to an interior surface of the wall.

[0034] Optionally, the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.

[0035] Optionally, the medical device further includes a locking mechanism configured to lock the tubular structure with respect to the guidewire delivery device.

[0036] Optionally, the tubular structure is made from a polymer.

[0037] Optionally, the second end of the tubular structure is configured to shape a guidewire in response to application of force applied to the guidewire to urge the guidewire against the second end of the tubular structure.

[0038] A method of using a medical device, the medical device comprising a tubular structure having a first end, a second end, a body extending between the first end and the second end, and a lumen extending between the first end and the second end, the method includes: detachably couple the first end of the tubular structure to a distal end of a guidewire delivery device; and advancing a guidewire distally relative to the guidewire delivery device and relative to the tubular structure until a distal end of the guidewire exits from the lumen of the tubular structure.

[0039] Optionally, the method further includes using the second end of the tubular structure to shape the guidewire.

[0040] Optionally, the act of using the second end of the tubular structure to shape the guidewire is performed after the first end of the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0041] Optionally, the method further includes inserting the second end of the tubular structure into a catheter hub.

[0042] Optionally, the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.

[0043] Optionally, the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allowAttorney Docket: 22-032 PCT the second end of the tubular structure to abut against an inner surface of the catheter hub, and wherein the act of inserting is performed until the second end of the tubular structure abuts against the inner surface of the catheter hub.

[0044] Optionally, the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0045] Optionally, the tubular structure comprises a wall, and wherein a part of the wall at the first end of the tubular structure is configured to extend over an outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

[0046] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

[0047] Optionally, the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is nonperpendicular with respect to an interior surface of the wall.

[0048] Optionally, the tubular structure has a funnel shape.

[0049] Optionally, the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.

[0050] Optionally, a majority of a longitudinal side of the tubular structure has a rectilinear profile.

[0051] Optionally, a majority of a longitudinal side of the tubular structure has a curvilinear profile.

[0052] Optionally, the method further includes locking the tubular structure with respect to the guidewire delivery device using a locking mechanism.

[0053] Optionally, the tubular structure is made from a polymer.

[0054] Optionally, at least a part of the lumen of the tubular structure has a tapered configuration.

[0055] Optionally, the part of the lumen having the tapered configuration is a majority part of the lumen.Attorney Docket: 22-032 PCT

[0056] Optionally, the part of the lumen having the tapered configuration is a minority part of the lumen at a location that is closer to the second end of the tubular structure than to the first end of the tubular structure.

[0057] Other and further aspects and features will be evident from reading the following detailed description.DESCRIPTION OF THE DRAWINGS

[0058] The drawings illustrate the design and utility of embodiments, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only exemplary embodiments and are not therefore to be considered limiting in the scope of the claims.

[0059] FIG. 1 illustrates a medical device;

[0060] FIG. 2A illustrates the medical device of FIG. 1 , showing the medical device is a side cross-sectional view;

[0061] FIG. 2B illustrates the medical device of FIG. 1 , showing the medical device being detachably coupled with a guidewire delivery device;

[0062] FIG. 2C illustrates the medical device of FIG. 1, showing exemplary dimensions;

[0063] FIG. 3 illustrates the medical device of FIG. 1, showing the medical device being used to shape a guidewire;

[0064] FIG. 4 illustrates the medical device of FIG. 1, showing the medical device detachably coupled with a guidewire delivery device, and being used to insert a guidewire into a catheter hub;

[0065] FIGS. 5A-5B illustrate a variation of the medical device of FIG. 1 ; and

[0066] FIG. 6 illustrates a method of using the medical device of FIG. 1 .DETAILED DESCRIPTION

[0067] Various embodiments are described hereinafter with reference to the figures. The figures are not necessarily drawn to scale, and elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be understood that the figures are only intended to facilitate theAttorney Docket: 22-032 PCT description of the embodiments, and are not intended as an exhaustive description of the claimed inventions, or as a limitation on the scope thereof, which is defined only by the appended claims and their equivalents.

[0068] In addition, the respective illustrated embodiments need not have all of the depicted features. Also, an aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.

[0069] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0070] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. Also, in some cases, “about” may refer to a range of values that are within + / - 10%, + / - 5%, or + / - 1% of the stated value. For example, “about 5 cm” may refer to a range of values that are 5 cm + / - 0.5 cm, or + / - 0.25 cm or + / - 0.05 cm.

[0071] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0072] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0073] FIG. 1 illustrates a medical device 100. The medical device 100 includes: a tubular structure 110 having a first end 112, a second end 114, and a body 116 extending between the first end 112 and the second end 114. The first end 1 14 of the tubular structure 110 is configured to detachably couple to a distal end 202 of a guidewire delivery device 200. The second end 114 of the tubular structure 110 is distal to the first end 112 of the tubular structure 110. The second end 114 of the tubular structure 110 has an opening 120 that is larger than an introducer opening 210 at the distal end 202 of the guidewire delivery device 200. The tubular structure 110Attorney Docket: 22-032 PCT comprises a lumen 140 extending between the first end 112 and the second end 114. At least a part of the lumen 140 has a tapered configuration.

[0074] In some cases, the part of the lumen 140 having the tapered configuration is a majority part of the lumen 140. In other cases, the part of the lumen 140 having the tapered configuration is a minority part of the lumen 140 at a location that is closer to the second end 114 of the tubular structure 110 than to the first end 112 of the tubular structure 110.

[0075] The tubular structure 110 has an interior surface 150 defining the lumen 140 of the tubular structure 110, wherein the interior surface 150 has a proximal edge 152 that forms a continuous and / or a smooth transition with an inner surface 230 of the guidewire delivery device 200 when the tubular structure 110 is detachably coupled to the distal end 202 of the guidewire delivery device 200 (see FIG. 2B). In other cases, the proximal edge 152 of the interior surface 150 of the tubular structure 110 may form a slight gap with the inner surface 230 of the guidewire delivery device 200. The gap may be less than 2 mm, less than 1 mm, less than 0.5 mm, less than 0.3 mm, less than 0.1 mm, less than 0.05 mm, less than 0.03 mm, less than 0.01 mm, etc.

[0076] The tubular structure 110 comprises a wall 160, and wherein a part 162 of the wall 160 of the tubular structure 110 is configured to extend over an outer surface 240 of the guidewire delivery device 200 when the tubular structure 110 is detachably coupled to the distal end 202 of the guidewire delivery device 200.

[0077] In some cases, the part 162 of the wall 160 that is configured to extend over the outer surface 240 of the guidewire delivery device 200 extends along a majority of a longitudinal length of the tubular structure 110. In other cases, the part 162 of the wall 160 that is configured to extend over the outer surface 240 of the guidewire delivery device 200 extends along a minority of a longitudinal length of the tubular structure 110.

[0078] In some cases, a tip 162 of the wall 160 of the tubular structure 110 at the second end 114 of the tubular structure 110 forms a smooth transition with the interior surface 150 of the wall 160.

[0079] In some cases, the tip 162 of the wall 160 of the tubular structure 110 at the second end 114 of the tubular structure 110 may have a tip surface 164 that is nonperpendicular with respect to an interior surface 150 of the wall 160.Attorney Docket: 22-032 PCT

[0080] In some cases, the tubular structure 110 may have a funnel shape. In other cases, the tubular structure 110 may have a non-funnel shape, such as a straight tubular configuration.

[0081] In some cases, the tubular structure 110 may have a smooth interior surface 150 extending along a majority of a longitudinal length of the tubular structure 110. In other cases, the tubular structure 110 may have a texturized interior surface 150 extending along a majority or a minority of a longitudinal length of the tubular structure 110.

[0082] As shown in FIG. 1 , a majority of a longitudinal side of the tubular structure 110 may have a curvilinear profile. In other cases, a majority of a longitudinal side of the tubular structure 110 may have a rectilinear profile.

[0083] In some cases, the medical device 100 optionally further includes a locking mechanism configured to lock the tubular structure 110 with respect to the guidewire delivery device 200. By means of non-limiting examples, the locking mechanism may be a screw connector, a pin connector, a snap-fit connector, an anchor, or a frictional connector. In one implementation, the inner surface of the wall of the tubular structure 110 may be configured to frictionally engage with an outer surface of the guidewire delivery device 200.

[0084] The tubular structure 100 may be made from a polymer. In other cases, the tubular structure 100 may be made from a metal, an alloy, a 3D printing material, etc. Also, in some cases, the tubular structure 100 may be made from multiple different materials. For example, in some cases, the tubular structure 100 may be made from two concentric tubular elements (an inner tubular element and an outer tubular element). The tubular elements may be made from different respective materials having different elastic modulus and different respective hardness. The two tubular elements may be molded together, glued together, or welded together to form a laminated tubular structure.

[0085] In some cases, the medical device 100 may optionally further include a coating that coats the inner surface 150 of the wall 160 defining the lumen 140. The coating may provide a smoother surface (compared to the surface when no coating is applied) in order to allow the guidewire to slide more easily against the surface. In other cases, the coating is optional, and the medical device 100 may not include any coating.Attorney Docket: 22-032 PCT

[0086] FIG. 2A illustrates a side cross-sectional view of the medical device 100 of FIG. 1 . As shown in the figure, the first end 112 of the tubular structure 110 defines a lumen 130 configured to accommodate the distal end 202 of the guidewire delivery device 200. The lumen 130 is a proximal part of the lumen 140. The first end 112 of the tubular structure 110 also defines an opening 132 configured to allow the distal end 202 of the guidewire delivery device 200 to be inserted therein. Also, as shown in the figure, the wall 160 of the tubular structure 110 defines a step 134 having a step height. The step height may be equal to a wall thickness at the distal end 202 of the guidewire delivery device 200. Alternatively, the step height may be less than the wall thickness at the distal end 202 of the guidewire delivery device 200. Due to the step 134, the proximal end of the lumen 140 has a cross-sectional dimension that is less than the cross-sectional dimension of the lumen 130. However, the cross-sectional dimension 136 of the distal opening 120 is larger than the cross-sectional dimension 242 of the lumen of the guidewire delivery device 200.

[0087] FIG. 2B illustrates the medical device 100 of FIG. 1 , showing the medical device 100 being detachably coupled with a guidewire delivery device 200. As shown in the figure, after the medical device 100 is detachably coupled with the guidewire delivery device 200, the interior surface 150 of the tubular structure 110 forms a continuous surface with the interior surface 230 of the guidewire delivery device 200. This can be achieved by configuring the step 134 to have a step height that is the same as the wall thickness of the guidewire delivery device 200. In other cases, there may be a slight gap between the two interior surfaces 230, 150, as described herein. Also, in other cases, the interior surfaces 230, 150 may not aligned with each other, and may form a slight step.

[0088] In some cases, the lumen 130 at the first end (proximal end) 112 of the tubular structure 110 may have a cross-sectional dimension that is less than an exterior cross-sectional dimension at the distal end 202 of the guidewire delivery device 200. In such cases, as the distal end 202 of the guidewire delivery device 200 is pushed into the lumen 130, the part 162 of the wall 160 of the tubular structure 110 may elastically expand radially in response to the insertion force exerted by the guidewire delivery device 200 towards the tubular structure 110. Such feature may enhance the coupling force (e.g., the frictional coupling force) between the medical device 100 and the guidewire delivery device 200. In other cases, the lumen 130 at the first end (proximal end) 112 of the tubular structure 110 may have a cross-sectionalAttorney Docket: 22-032 PCT dimension that is the same as an exterior cross-sectional dimension at the distal end 202 of the guidewire delivery device 200.

[0089] FIG. 2C illustrates the medical device 100 of FIG. 1 , showing exemplary dimensions. In some cases, the tubular structure 110 of medical device 100 may have a total longitudinal length 250 that is anywhere from 10 mm to 50 mm, or from 15 mm to 40 mm, or from 15 mm to 30 mm, or from 18 mm to 22 mm, or 20 mm + / - 3 mm, etc. Also, in some cases, the cross-sectional dimension 252 (e.g., diameter) of the proximal end 112 of the tubular structure 110 may be anywhere from 2 mm to 8 mm, or from 2 mm to 6 mm, or from 3 mm to 5 mm, or 4 mm + / - 0.5 mm, etc. The cross- sectional dimension 254 (e.g., diameter) of the distal end 114 of the tubular structure 110 may be anywhere from 5 mm to 10 mm, or from 6 mm to 8 mm, etc. The width 256 (measured in a direction that is perpendicular to the longitudinal axis of the tubular structure 110) of the proximal lumen 270 extending from the proximal end 112 may be anywhere from 0.8 mm to 1.2 mm, or from 0.9 mm to 1.1 mm, such as 1 mm, etc. The proximal lumen 270 is configured to receive the distal end of the guidewire delivery device 200. The width 258 (measured in a direction that is perpendicular to the longitudinal axis of the tubular structure 110) of the proximal end of the distal lumen 272 extending from the distal end of the proximal lumen 270 may be anywhere from 0.4 mm to 0.8 mm, or from 0.5 mm to 0.7 mm, such as 0.6 mm, etc.

[0090] In other cases, the medical device 100 may have dimensions that are different from the above examples. For example, in some cases, the medical device 100 may be used in interventional cardiology cases (involving use of coronary wires) and peripheral cases (involving use of peripheral wires). In such cases, the dimensions of the medical device 100 may be configured to fit the particular application.

[0091] As shown in the figure, the different dimensions of the lumens 270, 272 results in a step. After the distal end of the guidewire delivery device 200 (or insertion tool) is inserted into the proximal lumen 270, and is advanced, the distal end of the guidewire delivery device 200 (or insertion tool) can only reach until the step. However, the distal end of the guidewire can exit from the distal opening of the medical device 100.

[0092] In some cases, the medical device 100 may be made from a solid component (e.g., a solid block). In such cases, the proximal lumen 270 and the distal lumen 272 may be cut out from the solid block. In other cases, the medical deviceAttorney Docket: 22-032 PCT100 may be made from a solid cylinder. In such cases, the lumen of the solid cylinder may be processed (e.g., by grinding and / or cutting the inner surface of the solid cylinder) to form the proximal lumen 270 and the distal lumen 272.

[0093] During use, the medical device 100 is detachably coupled to the distal end 202 of the guidewire delivery device 200. The guidewire delivery device 200 may be a needle, a catheter, or any tube configured to house a guidewire and / or to deliver a distal segment of the guidewire to a site within a patient or to another medical device.

[0094] In some cases, if a user wants to shape the guidewire, the medical device 100 may be used to shape the guidewire. FIG. 3 illustrates the medical device 100 of FIG. 1 , showing the medical device 100 being used to shape a guidewire 300. After the distal end 302 of the guidewire 300 is delivered out of the second end 114 of the tubular structure 110, a distal segment 310 of the guidewire 300 may be shaped by bending the distal segment 310 of the guidewire 300 towards the edge or the tip 162 at the second end 114 of the tubular structure 110. In such cases, the second end 114 of the tubular structure 1 10 is configured to shape the guidewire 300 in response to application of force applied to the guidewire 300 to urge the guidewire 300 against the second end 114 of the tubular structure 110. The bending may continue using the tubular structure 110 as a mandrel until a desired degree of bending is achieved for the guidewire 300. In the illustrated example, the guidewire 300 may be made from a malleable material that allows the guidewire 300 to be bent to a desired shape.

[0095] After the guidewire 300 has been bent, the guidewire 300 may then be pulled proximally relative to the tubular structure 110 until the distal end 302 of the guidewire 300 is inside the tubular structure 110 of the medical device 100.

[0096] In some cases, the guidewire 300 may be further retracted proximally relative to the guidewire delivery device 200 until the distal end 302 of the guidewire 300 is inside the guidewire delivery device 200. In such cases, the medical device 100 may be decoupled from the guidewire delivery device 200 while the guidewire 300 is inside the guidewire delivery device 200. The guidewire delivery device 200 may then be used to deliver the distal end 302 of the guidewire 300 to a location inside a patient, and / or to another medical device, such as a catheter.

[0097] It should be noted that the curvilinear surface at the tip 162 of the tubular structure 1 10 is advantageous because it prevents the guidewire 300 from being damaged while the distal end 114 of the tubular structure 110 is being used to shape the guidewire 300. Also, after the guidewire 300 has been bent by the medical deviceAttorney Docket: 22-032 PCT100, the guidewire 300 may be pulled back into the guidewire delivery device 200 through the medical device 100. During such action, the medical device 100 also protects the guidewire 300 from being damaged because the medical device 100 has a smooth interior surface 150 providing an obstruction-free zone in which the guidewire 300 may be maneuvered. If the medical device 100 is not used, when the bent guidewire 300 is retracted into the lumen of the guidewire delivery device 200, the tip of the guidewire delivery device 200 may damage the guidewire 300 due to its sharp edge.

[0098] It should be noted that while the guidewire delivery device 200 is containing the guidewire 300, the curvilinear segment 310 of the guidewire 300 is “unbent” and confined inside the lumen of the guidewire delivery device 200. The segment 310 of the guidewire 300 that is “straightened” or “unbent” inside the lumen of the guidewire delivery device 200 may or may not have a rectilinear configuration. Thus, the terms “straightened” and “unbent” describe the condition in which the curvilinear segment 310 is less curved (e.g., having a larger radius of curvature) when inside the lumen of the guidewire delivery device 200 compared to the condition when the curvilinear segment 310 is outside the lumen of the guidewire delivery device 200.

[0099] In other cases, instead of decoupling the medical device 100 from the guidewire delivery device 200, the medical device 100 may stay connected to the guidewire delivery device 200. In such cases, the medical device 100 may be used to introduce the guidewire 300 into another medical device, such as a catheter hub or a catheter lumen of a catheter. FIG. 4 illustrates the medical device 100 of FIG. 1 , showing the medical device 100 detachably coupled with a guidewire delivery device 200, and being used to insert a guidewire 300 into a catheter hub 400. As shown in the figure, the second end 114 of the tubular structure 110 has a cross-sectional dimension that is less than a first inner diameter 410 at a proximal hub end 412 of a catheter hub 400 to thereby allow the second end 114 of the tubular structure 110 to be inserted into the catheter hub 400. The cross-sectional dimension of the second end 114 of the tubular structure 110 is larger than a second inner diameter 420 of the catheter hub 400 to thereby allow the second end 114 of the tubular structure 110 to abut against an inner surface 430 of the catheter hub 400. The above feature is advantageous because it allows the second end 114 (the distal end) of the tubular structure 110 to be easily inserted into the catheter hub 400, and also allows theAttorney Docket: 22-032 PCT second end 1 14 of the tubular structure 110 to stop at an intermediate location between opposite ends of the catheter hub 400.

[0100] In some cases, after the medical device 100 is inserted into the catheter hub 400, the medical device 100 may be secured to an internal part of the catheter hub 400, such as via friction. Alternatively, instead of securing the medical device 100 to the internal part of the catheter hub 400 via friction, the medical device 100 may be coupled to the catheter hub 400 via another securing mechanism, or may be held in place by the user. For example, in other cases, the medical device 100 may include a snap fit coupler that couples to an internal part of the catheter hub 400. As another example, the medical device 100 may include a screw implemented on a surface of the tubular structure 110. In such cases, the medical device 100 may be coupled to the catheter hub 400 by screwing the medical device 100 into a mating screw-hole inside the catheter hub 400. Also, in other cases, instead of securing the medical device 100 against an internal part of the catheter hub 400, the medical device 100 may be inserted into the catheter lumen of a catheter. The medical device 100 may be secured to an internal part (e.g., a wall) of the catheter via friction or via another securing mechanism (e.g., snap-fit connector, screw connector, etc.). Alternatively, the medical device 100 may be held in place by the user.

[0101] When the medical device 100 is inserted into the catheter hub 400, the medical device 100 and the inner wall of the catheter hub 400 are frictionally engaged with each other, thereby coupling the medical device 100 with the catheter hub 400. The hub lumen of the catheter hub 400 is in fluid communication with a catheter lumen in a catheter. Accordingly, the guidewire 300 may be advanced distally into the hub lumen of the catheter hub 400, and into the catheter lumen of the catheter. Alternatively, the catheter lumen of the catheter may directly accommodate the medical device 100. In such cases, the guidewire 300 may be introduced directly into the catheter lumen without going through the catheter hub 400.

[0102] In particular, the guidewire 300 may be advanced distally relative to the guidewire delivery device 200, so that the distal segment 310 of the guidewire 300 inters into the catheter hub 400 and / or into a catheter lumen of the catheter. The guidewire 300 may be advanced further until the distal segment 310 of the guidewire 300 exits from the distal end of the catheter, and into a patient’s body. After the distal segment 310 has exited from the distal end of the catheter, the distal segment 310Attorney Docket: 22-032 PCT may assume a more curvilinear configuration (a bent configuration), which allows a user to access different parts of the patient’s body.

[0103] In the illustrated example, the distal opening 120 of the tubular structure 110 has a cross-sectional dimension 136 (measured perpendicularly with respect to a longitudinal axis of the tubular structure 110) that is slightly larger (e.g., larger by 30% or less, or 20% or less, or 10% or less, etc.) than the narrowest part of the hub lumen of the catheter hub 400. Thus, after the distal segment 310 of the guidewire 300 exits from the distal end of the medical device 100, the distal segment 310 freely enters into the hub lumen of the catheter hub 400 and / or into the catheter lumen of the catheter without encountering any obstacle. The distal segment 310 may assume a partial bent configuration in which the radius of curvature of the distal segment 310 is smaller compared to that when the distal segment 310 is confined within the lumen of the guidewire delivery device 200. However, when accommodated inside the catheter lumen of the catheter, the distal segment 310 of the guidewire 300 remains relatively “straight” and “unbent” in the sense that the distal segment 310 has a radius of curvature that is larger than that when the distal segment 310 is freely unconfined outside the catheter. In other cases, the distal opening 120 of the tubular structure 110 has a cross-sectional dimension 136 (measured perpendicularly with respect to a longitudinal axis of the tubular structure 110) that is larger than the narrowest part of the hub lumen by more than 30%.

[0104] In some cases, the medical device 100 may optionally be removed during a procedure by moving the medical device 100 proximally relative to the guidewire 300 (while the distal segment 310 of the guidewire 300 is inside the patient) until the medical device 100 slips off the guidewire 300 proximal end.

[0105] It should be noted that the medical device 100 is not limited to having the above features, and that one or more of the above features may not be required for the medical device 100. For example, in other cases, the tubular structure 110 may not have a funnel shape. FIGS. 5A-5B illustrate a variation of the medical device 100 of FIG. 1 . The medical device 100 includes: a tubular structure 110 having a first end 112, a second end 114, and a body 116 extending between the first end 112 and the second end 114. The first end 112 of the tubular structure 110 is configured to detachably couple to a distal end of a guidewire delivery device 200. The second end 114 of the tubular structure 110 is distal to the first end 1 12 of the tubular structure 110. The second end 114 of the tubular structure 110 has an opening 120 that isAttorney Docket: 22-032 PCT larger than an introducer opening 210 at the distal end 202 of the guidewire delivery device 200. The tubular structure 100 comprises a lumen 140 extending between the first end 112 and the second end 114. The tubular structure 110 has a wall 160 with an exterior surface 502, and wherein a majority of a longitudinal side of the exterior surface 502 of the wall 160 of the tubular structure 110 is parallel to a longitudinal axis 500 of the tubular structure 110.

[0106] The medical device 100 of FIGS. 5A-5B may have any (e.g., one, a combination of two or more, or all) of the features described with reference to FIGS. 1-4

[0107] In some cases, the medical device 100 described herein may optionally also include the guidewire delivery device 200. In such cases, the medical device 100 includes both the tubular structure 110 and the guidewire delivery device 200. In further cases, the medical device 100 may optionally further include the guidewire 300. In further cases, the medical device 100 may optionally further include the catheter hub 400 or the catheter having the catheter hub 400. By means of non-limiting examples, the catheter or the catheter hub 400 may be part of an implant delivery system, a drug delivery system, a biopsy system, a treatment system that includes an energy source, etc.

[0108] Although the medical device 100 has been described with reference to it being used to assist delivery of the guidewire 300 into a catheter hub of a catheter, in other cases, the medical device 100 may be used to assist delivery of the guidewire 300 into other medical devices or into a patient’s body (instead of the catheter lumen). For example, in other cases, the medical device 100 may be used to assist delivery of the guidewire 300 into a patient’s body through a trocar. In such cases, the catheter hub 400 may be replaced with a trocar, and the medical device 100 may be configured to be inserted into the trocar.

[0109] Also, in further cases, the medical device 100 may be considered as a guidewire introducer itself.

[0110] FIG. 6 illustrates a method 600 of using the medical device 100 of FIG. 1. The medical device 100 comprises a tubular structure 1 10 having a first end 112, a second end 114, a body 116 extending between the first end 112 and the second end 114, and a lumen 140 extending between the first end 112 and the second end 114. The method 600 includes: detachably couple the first end of the tubular structure to a distal end of a guidewire delivery device (item 602), and advancing a guidewire distallyAttorney Docket: 22-032 PCT relative to the guidewire delivery device and relative to the tubular structure until a distal end of the guidewire exits from the lumen 140 of the tubular structure (item 604).

[0111] Optionally, the method 600 further includes using the second end 114 of the tubular structure 110 to shape the guidewire 300.

[0112] Optionally, in the method 600, the act of using the second end 1 14 of the tubular structure 1 10 to shape the guidewire 300 is performed after the first end 112 of the tubular structure 110 is detachably coupled to the distal end of the guidewire delivery device 200.

[0113] Optionally, the method 600 further includes inserting the second end 114 of the tubular structure 110 into a catheter hub 400.

[0114] Optionally, in the method 600, the second end 114 of the tubular structure 110 has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub 400 to thereby allow the second end 114 of the tubular structure 1 10 to be inserted into the catheter hub 400.

[0115] Optionally, in the method 600, the cross-sectional dimension of the second end 114 of the tubular structure 110 is larger than a second inner diameter of the catheter hub 400 to thereby allow the second end 114 of the tubular structure 110 to abut against an inner surface of the catheter hub 400, and wherein the act of inserting is performed until the second end 114 of the tubular structure 110 abuts against the inner surface of the catheter hub 400.

[0116] Optionally, in the method 600, the tubular structure 110 has an interior surface 150 defining the lumen 140 of the tubular structure 110, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device 200 when the tubular structure 110 is detachably coupled to the distal end of the guidewire delivery device 200.

[0117] Optionally, in the method 600, the tubular structure 110 comprises a wall 160, and wherein a part of the wall 160 at the first end 112 of the tubular structure 110 is configured to extend over an outer surface of the guidewire delivery device 200 when the tubular structure 110 is detachably coupled to the distal end of the guidewire delivery device 200.

[0118] Optionally, in the method 600, the tubular structure 110 comprises a wall 160, and wherein a tip 162 of the wall 160 at the second end 114 of the tubular structure 110 forms a smooth transition with an interior surface of the wall 160.Attorney Docket: 22-032 PCT

[0119] Optionally, in the method 600, the tubular structure 110 comprises a wall 160, and wherein a tip 162 of the wall 160 at the second end 114 of the tubular structure 110 has a tip surface that is non-perpendicular with respect to an interior surface of the wall 160.

[0120] Optionally, in the method 600, the tubular structure 110 has a funnel shape.

[0121] Optionally, in the method 600, the tubular structure 110 has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure 110.

[0122] Optionally, in the method 600, a majority of a longitudinal side of the tubular structure 110 has a rectilinear profile.

[0123] Optionally, in the method 600, a majority of a longitudinal side of the tubular structure 110 has a curvilinear profile.

[0124] Optionally, the method 600 further includes locking the tubular structure 110 with respect to the guidewire delivery device 200 using a locking mechanism.

[0125] Optionally, in the method 600, the tubular structure 110 is made from a polymer.

[0126] Optionally, in the method 600, at least a part of the lumen 140 of the tubular structure 110 has a tapered configuration.

[0127] Optionally, in the method 600, the part of the lumen 140 having the tapered configuration is a majority part of the lumen 140.

[0128] Optionally, in the method 600, the part of the lumen 140 having the tapered configuration is a minority part of the lumen 140 at a location that is closer to the second end 114 of the tubular structure 110 than to the first end 112 of the tubular structural 10.

[0129] It should be noted that the method 600 is not limited to being performed using the medical device 100 of FIG. 1 , and that the method 600 may be performed using other medical devices in other cases.

[0130] Although particular embodiments have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the disclosed inventions, and it will be obvious to those skilled in the art that various changes, permutations, and modifications may be made (e.g., the dimensions of various parts, combinations of parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative ratherAttorney Docket: 22-032 PCT than restrictive sense. The various embodiments shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.

Claims

Attorney Docket: 22-032 PCTWhat is claimed is:1 . A medical device comprising: a tubular structure having a first end, a second end, and a body extending between the first end and the second end; wherein the first end of the tubular structure is configured to detachably couple to a distal end of a guidewire delivery device; wherein the second end of the tubular structure is distal to the first end of the tubular structure, and wherein the second end of the tubular structure has an opening that is larger than an introducer opening at the distal end of the guidewire delivery device; and wherein the tubular structure comprises a lumen extending between the first end and the second end, wherein at least a part of the lumen has a tapered configuration.

2. The medical device of claim 1 , wherein the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

3. The medical device of claim 1 , wherein the tubular structure comprises a wall, and wherein a part of the wall of the tubular structure is configured to extend over an outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

4. The medical device of claim 3, wherein the part of the wall that is configured to extend over the outer surface of the guidewire delivery device extends along a majority of a longitudinal length of the tubular structure.

5. The medical device of claim 1 , wherein the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.Attorney Docket: 22-032 PCT6. The medical device of claim 5, wherein the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allow the second end of the tubular structure to abut against an inner surface of the catheter hub.

7. The medical device of claim 1 , wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

8. The medical device of claim 1 , wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is non-perpendicular with respect to an interior surface of the wall.

9. The medical device of claim 1 , wherein the tubular structure has a funnel shape.

10. The medical device of claim 1 , wherein the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.11 . The medical device of claim 1 , wherein a majority of a longitudinal side of the tubular structure has a rectilinear profile.

12. The medical device of claim 1 , wherein a majority of a longitudinal side of the tubular structure has a curvilinear profile.

13. The medical device of claim 1 , further comprising a locking mechanism configured to lock the tubular structure with respect to the guidewire delivery device.

14. The medical device of claim 1 , wherein the tubular structure is made from a polymer.Attorney Docket: 22-032 PCT15. The medical device of claim 1 , wherein the second end of the tubular structure is configured to shape a guidewire in response to application of force applied to the guidewire to urge the guidewire against the second end of the tubular structure.

16. The medical device of claim 1 , wherein the part of the lumen having the tapered configuration is a majority part of the lumen.

17. The medical device of claim 1 , wherein the part of the lumen having the tapered configuration is a minority part of the lumen at a location that is closer to the second end of the tubular structure than to the first end of the tubular structure.

18. A medical device comprising: a tubular structure having a first end, a second end, and a body extending between the first end and the second end; wherein the first end of the tubular structure is configured to detachably couple to a distal end of a guidewire delivery device; wherein the second end of the tubular structure is distal to the first end of the tubular structure, and wherein the second end of the tubular structure has an opening that is larger than an introducer opening at the distal end of the guidewire delivery device; wherein the tubular structure comprises a lumen extending between the first end and the second end; and wherein the tubular structure has a wall with an exterior surface, and wherein a majority of a longitudinal side of the exterior surface of the tubular structure is parallel to a longitudinal axis of the tubular structure.

19. The medical device of claim 18, wherein the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

20. The medical device of claim 18, wherein the tubular structure comprises a wall, and wherein a part of the wall of the tubular structure is configured to extend over anAttorney Docket: 22-032 PCT outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.21 . The medical device of claim 20, wherein the part of the wall that is configured to extend over the outer surface of the guidewire delivery device extends along a majority of a longitudinal length of the tubular structure.

22. The medical device of claim 18, wherein the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.

23. The medical device of claim 22, wherein the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allow the second end of the tubular structure to abut against an inner surface of the catheter hub.

24. The medical device of claim 18, wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

25. The medical device of claim 18, wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is non-perpendicular with respect to an interior surface of the wall.

26. The medical device of claim 18, wherein the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.

27. The medical device of claim 18, further comprising a locking mechanism configured to lock the tubular structure with respect to the guidewire delivery device.

28. The medical device of claim 18, wherein the tubular structure is made from a polymer.Attorney Docket: 22-032 PCT29. The medical device of claim 18, wherein the second end of the tubular structure is configured to shape a guidewire in response to application of force applied to the guidewire to urge the guidewire against the second end of the tubular structure.

30. A method of deploying a guidewire using a tubular structure, the tubular structure having a first end, a second end, a body extending between the first end and the second end, and a lumen extending between the first end and the second end, the method comprising: detachably coupling the first end of a tubular structure to a distal end of a guidewire delivery device; and advancing a guidewire through the lumen of the tubular structure until a distal end of the guidewire exits a distal end opening of the tubular structure in communication with the lumen.31 . The method of claim 30, further comprising using the second end of the tubular structure to shape the guidewire.

32. The method of claim 31 , wherein the act of using the second end of the tubular structure to shape the guidewire is performed after the first end of the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

33. The method of claim 30, further comprising inserting the second end of the tubular structure into a catheter hub.

34. The method of claim 33, wherein the second end of the tubular structure has a cross-sectional dimension that is less than a first inner diameter at a proximal hub end of a catheter hub to thereby allow the second end of the tubular structure to be inserted into the catheter hub.

35. The method of claim 34, wherein the cross-sectional dimension of the second end of the tubular structure is larger than a second inner diameter of the catheter hub to thereby allow the second end of the tubular structure to abut against an inner surface of the catheter hub, and wherein the act of inserting is performed until the second end of the tubular structure abuts against the inner surface of the catheter hub.Attorney Docket: 22-032 PCT36. The method of claim 30, wherein the tubular structure has an interior surface defining the lumen of the tubular structure, wherein the interior surface has a proximal edge that forms a continuous and / or a smooth transition with an inner surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

37. The method of claim 30, wherein the tubular structure comprises a wall, and wherein a part of the wall at the first end of the tubular structure is configured to extend over an outer surface of the guidewire delivery device when the tubular structure is detachably coupled to the distal end of the guidewire delivery device.

38. The method of claim 30, wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure forms a smooth transition with an interior surface of the wall.

39. The method of claim 30, wherein the tubular structure comprises a wall, and wherein a tip of the wall at the second end of the tubular structure has a tip surface that is non-perpendicular with respect to an interior surface of the wall.

40. The method of claim 30, wherein the tubular structure has a funnel shape.

41. The method of claim 30, wherein the tubular structure has a smooth interior surface extending along a majority of a longitudinal length of the tubular structure.

42. The method of claim 30, wherein a majority of a longitudinal side of the tubular structure has a rectilinear profile.

43. The method of claim 30, wherein a majority of a longitudinal side of the tubular structure has a curvilinear profile.

44. The method of claim 30, further comprising locking the tubular structure with respect to the guidewire delivery device using a locking mechanism.Attorney Docket: 22-032 PCT45. The method of claim 30, wherein the tubular structure is made from a polymer.

46. The method of claim 30, wherein at least a part of the lumen of the tubular structure has a tapered configuration.

47. The method of claim 46, wherein the part of the lumen having the tapered configuration is a majority part of the lumen.

48. The method of claim 46, wherein the part of the lumen having the tapered configuration is a minority part of the lumen at a location that is closer to the second end of the tubular structure than to the first end of the tubular structure.

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