MECHANICAL EXPANDER

Abstract

A mechanical dilator is described, which may include a first arm coupled to a second arm by a fulcrum, the first and second arms cooperatively defining a locking and stopping mechanism configured to limit the lateral movement of the first arm relative to the second arm. The mechanical dilator may further include a dilator body having a first side extending from the first arm and a second side extending from the second arm, wherein the fulcrum is configured to transfer the lateral movement of the first arm relative to the second arm to the lateral movement of the first side relative to the second side.

Description

MECHANICAL EXPANDER PRIORITY

[0001] This application claims the benefit of priority of U.S. Patent Application No. 63 / 113,719, filed November 13, 2020, which is incorporated by reference in this application. BACKGROUND OF THE INVENTION

[0002] During a medical device placement procedure, the tissue around the insertion site must be dilated or expanded to allow the insertion of a medical device with a cross-sectional diameter larger than the insertion site. The process of expanding the tissue may involve multiple steps with multiple instruments. In addition, the clinician must visually determine how much the tissue around the insertion site needs to expand to facilitate the insertion of the medical device. Visual determination can lead to over-expansion of the tissue. It would be beneficial for both the clinician and the patient to be able to more accurately dilate the tissue around the insertion site using a single instrument. This document describes an apparatus, a system, and a method that address the above. BRIEF DESCRIPTION OF THE INVENTION

[0003] This document describes a mechanical dilator that includes a first arm coupled to a second arm by a fulcrum, the first arm and second arm cooperatively defining a locking and stopping mechanism configured to limit the lateral movement of the first arm with respect to the second arm, and a dilator body having a first side extending from the first arm and a second side extending from the second arm, wherein the fulcrum is configured to transfer the lateral movement of the first arm with respect to the second arm to the lateral movement of the first side with respect to the second side.

[0004] In some embodiments, the first arm is closer to the distal end of the dilator body than the second arm, or the second arm is closer to the distal end of the dilator body than the first arm.

[0005] In some embodiments, the first arm is displaced laterally from the second arm.

[0006] In some embodiments, the dilator body includes a channel that divides the dilator body into first and second sides. In some embodiments, the channel has a constant diameter and extends from the proximal end of each of the first and second arms to the tip of the dilator.

[0007] In some embodiments, the locking and stopping mechanism includes a first locking plate configured to slide into a second locking plate.

[0008] In some embodiments, the first locking plate attaches to the first arm and the second locking plate attaches to the second arm.

[0009] In some embodiments, the first locking plate and the second locking plate each include a tongue, a plurality of flanges, a recess, and a stop flange.

[0010] In some embodiments, the mechanical dilator can be configured to transition between an open configuration and a closed configuration.

[0011] In some embodiments, in the closed configuration, the first side and the second side are in physical contact.

[0012] In some embodiments, in the open configuration, the first side and the second side are at the maximum possible distance, the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

[0013] In some embodiments, the dilator body is separably coupled to the first arm and the second arm by means of a press fit, a snap fit, or an interference fit.

[0014] In some embodiments, the mechanical dilator is disposable or reusable.

[0015] In some embodiments, the proximal ends of each of the first arm and the second arm include chamfered edges.

[0016] Also described herein is a medical device insertion system that includes a guide wire and a mechanical dilator configured to slide on the guide wire. In some embodiments, the mechanical dilator includes a first arm coupled to a second arm by a fulcrum, the first and second arms cooperatively defining a locking and stopping mechanism. The mechanical dilator also includes a dilator body comprising a first side extending from the first arm and a second side extending from the second arm, a channel configured to slide on the guide wire, the channel dividing the dilator body into the first and second sides, wherein the fulcrum is configured to translate the movement of the first arm relative to the second arm into the lateral movement of the first side relative to the second side. Q7QCnn / C7n7 / R / VIAI

[0017] In some embodiments, the locking and stopping mechanism includes a first locking plate configured to slide-engage with a second locking plate. The first locking plate includes a first tab, a first plurality of flanges, a first recess, and a first stop flange, and the second locking plate includes a second tab, a second plurality of flanges, a second recess, and a second stop flange.

[0018] In some embodiments, the mechanical dilator is configured to switch from a closed configuration to an open configuration.

[0019] In some embodiments, the closed configuration includes the first side and the second side being in physical contact.

[0020] In some embodiments, in the open configuration, the first side and the second side are at the maximum possible distance and the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

[0021] In some embodiments, the mechanical dilator slides over the guide wire in the closed configuration or the mechanical dilator slides over the guide wire in the open configuration.

[0022] In some embodiments, the channel includes a consistent diameter.

[0023] In some embodiments, the tip of the dilator is sharpened to facilitate the entry of the dilator body into an insertion site.

[0024] Also described in this document is a method for using a mechanical dilator to dilate an insertion site that includes inserting a guide wire into an insertion site, sliding the mechanical dilator over the guide wire into the insertion site, dilating the tissue surrounding the insertion site by moving the mechanical dilator device from a closed configuration to an open configuration, and withdrawing the mechanical dilator from the guide wire.In some embodiments, the mechanical dilator includes a first arm coupled to a second arm by a fulcrum, the first arm and the second arm cooperatively defining a locking and stopping mechanism configured to limit the lateral movement of the first arm with respect to the second arm; the mechanical dilator having a dilator body comprising a first side extending from the first arm and a second side extending from the second arm, a channel dividing the dilator body into the first side and the second side, wherein the fulcrum is configured to transfer the lateral movement of the first arm with respect to the second arm to the lateral movement of the first side with respect to the second side.

[0025] In some embodiments, the locking and stopping mechanism includes a first locking plate attached to the first arm and a second locking plate attached to the Q7QCnn / C7n7 / R / VIAI second arm.

[0026] In some embodiments, the first locking plate includes a first tab, a first plurality of flanges, a first recess, and a first stop flange, and the second locking plate includes a second tab, a second plurality of flanges, a second recess, and a second stop flange.

[0027] In some embodiments, in the closed configuration, the first side and the second side are in physical contact with each other.

[0028] In some embodiments, in the open configuration, the first side and the second side are at the maximum possible distance, the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

[0029] In some embodiments, dilating the tissue surrounding the insertion site includes setting the lock-and-stop mechanism to prevent over-dilation of the insertion site.

[0030] In some embodiments, dilating the tissue surrounding the insertion site includes sliding an elongated medical device over the guide wire through the mechanical dilator channel toward the insertion site, when the mechanical dilator is in the open configuration.

[0031] In some embodiments, the elongated medical device includes a catheter.

[0032] In some embodiments, sliding the mechanical dilator over the guide wire includes sliding the mechanical dilator over the guide wire in the open configuration.

[0033] In some embodiments, sliding the mechanical dilator over the guide wire includes sliding the mechanical dilator over the guide wire in the closed configuration.

[0034] In some embodiments, the sliding of the mechanical dilator over the guide wire includes the transition of the mechanical dilator from the open configuration to the closed configuration prior to insertion at the insertion site.

[0035] These and other features of the concepts provided in this document will be more evident to those skilled in the art in view of the accompanying drawings and the following description, which describe particular embodiments of such concepts in greater detail. BRIEF DESCRIPTION OF THE FIGURES

[0036] A more specific description of this disclosure will be given with reference to specific embodiments thereof illustrated in the accompanying drawings. It should be noted that these drawings represent only typical embodiments of the invention and should therefore not be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained in further specificity and detail by use of the accompanying drawings, in which: Q7QCnn / C7n7 / R / VIAI

[0037] FIG. 1A illustrates a side view of a mechanical dilator, according to some embodiments.

[0038] FIG. IB illustrates a perspective view of the mechanical dilator, according to some embodiments.

[0039] FIG. 2A illustrates a perspective view of the dilator body, according to some embodiments.

[0040] FIG. 2B illustrates a plan view of a proximal end of the dilator body including a channel, according to some embodiments.

[0041] FIG. 3A illustrates a perspective view of a locking and stopping mechanism coupled to the mechanical dilator, according to some embodiments.

[0042] FIG. 3B illustrates a cross-sectional view of the locking and stopping mechanism coupled to the mechanical dilator, according to some embodiments.

[0043] FIG. 4A-4B illustrate a plan view of an exemplary method of expansion of a mechanical dilator, according to some embodiments.

[0044] FIG. 5A-5C illustrate a perspective view of an exemplary method of using a mechanical dilator in a medical device insertion system, according to some embodiments.

[0045] FIG. 6 illustrates a flow diagram of an exemplary method of using a mechanical dilator to dilate the tissue around an insertion site, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0046] Before some particular embodiments are described in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment described herein may have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features from any of the other embodiments described herein.

[0047] With respect to the terms used in this document, it should also be understood that the terms are intended to describe certain particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different functions or steps within a group of functions or steps, and do not provide a numerical or sequential limitation. For example, the features or steps first, second, and third do not have Q7QCnn / C7n7 / R / VIAI that do not necessarily appear in that order, and the particular realizations that include such features or steps need not be limited to all three features or steps. Labels such as left, right, up, down, front, back, and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. The singular forms of a / an and the / a include plural references unless the context clearly dictates otherwise.

[0048] With respect to proximal, a proximal portion or proximal end portion of, for example, a mechanical dilator described herein includes a portion of the mechanical dilator intended to be near a physician when the mechanical dilator is used on a patient. Likewise, a proximal length of, for example, the mechanical dilator includes a length of the mechanical dilator intended to be near the physician when the mechanical dilator is used on the patient. A proximal end of, for example, the mechanical dilator includes an end of the mechanical dilator intended to be near the physician when the mechanical dilator is used on the patient. The proximal portion, proximal end portion, or proximal length of the mechanical dilator may include the proximal end of the mechanical dilator; however, the proximal portion, proximal end portion, or proximal length of the mechanical dilator need not include the proximal end of the mechanical dilator.That is, unless the context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the mechanical dilator is not a terminal portion or a terminal length of the mechanical dilator.

[0049] With respect to distal, a distal portion or distal end portion of, for example, a mechanical dilator described herein includes a portion of the mechanical dilator intended to be near or in a patient when the mechanical dilator is used in the patient. Likewise, a distal length of, for example, the mechanical dilator includes a length of the mechanical dilator intended to be near or in the patient when the mechanical dilator is used in the patient. A distal end of, for example, the mechanical dilator includes an end of the mechanical dilator intended to be near or in the patient when the mechanical dilator is used in the patient. The distal portion, distal end portion, or distal length of the mechanical dilator may include the distal end of the mechanical dilator; however, the distal portion, distal end portion, or distal length of the mechanical dilator need not include the distal end of the mechanical dilator.That is, unless the context suggests otherwise, the distal portion, the distal end portion, or the distal length of the mechanical dilator is not a terminal portion or a terminal length of the mechanical dilator.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by Q7acnn / C7n7 / R / viAi experts in the field.

[0051] FIG. 1A illustrates a side view of a mechanical dilator 100, according to some embodiments. In some embodiments, the mechanical dilator 100 includes a first arm 104A and a second arm 104B. In some embodiments, a dilator body 110 extends from a distal end of the first arm 104A and a distal end of the second arm 104B. In some embodiments, the dilator body 110 extends to the tip of the dilator 112. In some embodiments, the first arm 104A and the second arm 104B together define a locking and stopping mechanism 120 that can be configured to limit the lateral movement of the first arm 104A with respect to the second arm 104B. As illustrated in FIG. 1A, in some embodiments, the first arm 104A may be closer to a distal end of the dilator body 110 than the second arm 104B.In some embodiments, the second arm 104B may be closer to the distal end of the dilator body 110 than the first arm 104A. In some embodiments, the first arm 104A may be displaced laterally from the second arm 104B.

[0052] FIG. IB illustrates a perspective view of the mechanical dilator 100, according to some embodiments. In some embodiments, the mechanical dilator 100 can be configured to transition between a closed and an open configuration. In some embodiments, the first arm 104A can be compressed toward the second arm 104B. In some embodiments, a portion of the first arm 104A makes contact with a portion of the second arm 104B when the first arm 104A and the second arm 104B are compressed against each other. In some embodiments, the locking and stopping mechanism 120 can be located where the first arm 104A contacts the second arm 104B. In some embodiments, the shape of the first arm 104A and the second arm 104B may include a rectangular prism, a conical rectangular prism, a rounded rectangular prism, a parallelepiped cylindrical pentagonal prism, a hexagonal prism, or a combination thereof or similar.In some embodiments, the first arm 104A and the second arm 104B can be coupled together by means of a fulcrum 116 extending between them. In some embodiments, the fulcrum 116 translates the lateral movement of the first arm 104A and the second arm 104B into movement of the dilator body 110, which will be described in more detail later in this document. In some embodiments, the dilator body 110 is divided in two by a channel 118.

[0053] FIG. 2A illustrates a perspective view of the body of dilator 110, according to some embodiments. As illustrated in FIG. 2A, the channel 118 divides the body of dilator 110 into two equal sides, a first side 114A extending from the first arm 104A and a second side 114B extending from the second arm 104B. The body of dilator 110 can be configured to expand or contract laterally by lateral movement of the first arm 104A and the second arm 104B. In some embodiments, the body of dilator 110 terminates at the tip of dilator 112, and the tip of dilator 112 can be tapered. In embodiments Q7QCnn / C7n7 / R / VIAI, the tip of dilator 112 can be sharpened to facilitate the insertion of the dilator body 110 into an insertion site. In some embodiments, the dilator body 110 is cylindrical. However, other shapes are also contemplated. Advantageously, the cylindrical shape of the dilator body 110 allows for equal circumferential expansion of the tissue surrounding the insertion site. In some embodiments, equal circumferential expansion reduces skin deviation and allows for a consistent insertion site size, leading to consistent placement of the medical device.

[0054] In one embodiment, the dilator body 110 can be detachably attached to the first arm 104A and the second arm 104B. In another embodiment, the dilator body 110 can be press-fitted, quickly, by interference fit, or similarly, to the first arm 104A and the second arm 104B. In this embodiment, the mechanical dilator 100 and the dilator body 110 can be supplied separately, and the dilator body 110 can then be attached to the first arm 104A and the second arm 104B before use. In some embodiments, several dilator bodies 110 having different channel diameters 117 can be detachably attached to the mechanical dilator 100. Having several dilator bodies 110 detachably attached to the mechanical dilator 100 allows the user to select, just before use, the desired dilation of the insertion site.In some embodiments, the mechanical dilator 100, which includes the body of the dilator 110, may be constructed of metals (e.g., steel, aluminum, or similar materials), plastics (e.g., polyester, polyethylene, polyvinyl chloride, polypropylene, or similar materials), or a combination thereof. In some embodiments, the mechanical dilator 100 or parts thereof, including the body of the dilator 110, may be configured to be reusable or disposable.

[0055] FIG. 2B illustrates the plan view of the first arm 104A and the second arm 104B of the mechanical dilator 100, according to some embodiments. In some embodiments, the channel 118 extends from the proximal side of the mechanical dilator 100 to the tip of the dilator 112. In some embodiments, the channel 118 can be configured to have a constant diameter 117 throughout the body of the dilator 110. In some embodiments, the proximal side of the channel 118 can include chamfered edges, configured to allow the sliding of medical devices within it. As the body of the dilator 110 expands laterally, the diameter 117 of the channel 118 can also expand. As the dilator body 110 expands laterally, the diameter 117 of the channel 118 can also expand uniformly.In some embodiments, the diameter 117 of channel 118 can be expanded to be larger than the diameter of the cross-section of an elongated medical device, allowing a portion of the elongated medical device to be moved through channel 118.

[0056] FIG. 3A illustrates a perspective view of a first locking plate 122A of the locking and stopping mechanism 120, according to some embodiments. In some In certain embodiments, the mechanical dilator 100 can be configured to include a portion of the locking and stopping mechanism 120 in the first arm 104A and a portion of the locking and stopping mechanism 120 in the second arm 104B. In some embodiments, the locking and stopping mechanism 120 includes the first locking plate 122A, which can be configured to slide-engage with a second locking plate 122B. In some embodiments, the first locking plate 122A includes a first tab 124A, a first plurality of flanges 126A projecting from the first locking plate 122A, a first recess 128A, and a first stop flange 130A. In some embodiments, the first locking plate 122A can be configured to slide-engage with a second tab 124B.In some embodiments, the mechanical dilator 100 may include the first locking plate 122A coupled to the first arm 104A and the second tab 124B coupled to the second arm 104B.

[0057] FIG. 3B illustrates a cross-sectional view of the first locking plate 122A and the second locking plate 122B of the locking and stopping mechanism 120 coupled to the mechanical expander 100, according to some embodiments. In some embodiments, the second locking plate 122B includes a second tab 124B, a second plurality of flanges 126B projecting from the second locking plate 122B, a second recess 128B, and a second stop flange 130B. In some embodiments, the first locking plate 122A can be coupled to the first arm 104A, and the second locking plate 122B can be coupled to the second arm 104B. As the first arm 104A and the second arm 104B are compressed laterally together, the first tab 124A slides into the second plurality of flanges 126B, and the second tab 124B slides into the first plurality of flanges 126A.The first arm 104A and the second arm 104B can be compressed laterally together until the first tab 124A is secured within the second recess 128B and the second tab 124B is secured within the first recess 128A. The first stop flange 130A prevents the second tab 124B and the second arm 104B from moving laterally, and the second stop flange 130B prevents the first tab 124A and the first arm 104A from moving laterally. The first stop flange 130A and the first recess 128A, and the second stop flange 130B and the second recess 128B, ensure that the channel 118 can be configured to open to its maximum possible diameter. In some embodiments, the first plurality of flanges 126A may be configured to have the same number of flanges as the second plurality of flanges 126B.In some embodiments, each flange within the first plurality of flanges 126A may be configured to have a corresponding flange within the second plurality of flanges 126B.

[0058] In one embodiment, when the first tab 124A passes each flange of the second plurality of flanges 126B and the second tab 124B passes each flange of the first plurality of flanges 126A, the user can be notified about the progress of the first tab Q7QCnn / C7n7 / R / VIAI 124A over the second plurality of flanges 126B and the second tab 124B over the second plurality of flanges 126B with an audible sound (e.g., a click, a snap, or the like). In this embodiment, the audible sound of the first tab 124A passing over each flange of the second plurality of flanges 126B and the second tab 124B passing over each flange of the first plurality of flanges 126A may correspond to an incremental increase in the expansion of the dilator body 110. In some embodiments, the locking and stopping mechanism 120 may include a visual indicator of the progress of the first tab 124A over the second plurality of flanges 126B and the second tab over the second plurality of flanges 126B.In one embodiment, the visual indicator may include each flange of the first plurality of flanges 126A and each corresponding flange of the second plurality of flanges 126B, which has a distinct color corresponding to a specific diameter of the channel 118. In this embodiment, the user may be able to visually determine the dilation progress of the dilator body 110 and the diameter 117 of the channel 118. In some embodiments, the audible sound and the visual indicator of the progress of the first tab 124A passing over each flange of the second plurality of flanges 126B and the second tab 124B passing over each flange of the first plurality of flanges 126A may be combined to provide the user with two different mechanisms for determining the dilation progress of the dilator body 110 and the diameter 117 of the channel 118.

[0059] In some embodiments, the locking and stopping mechanism 120 may be preconfigured for a maximum channel diameter 117 or a maximum distance between the first side 114A and the second side 114B. For example, the maximum channel diameter 117 may be configured to be greater than the diameter of a user-selected elongated medical device. In some embodiments, the number of flanges in the first flange plurality 126A before the first recess 128A and the number of flanges in the second flange plurality 126B before the second recess 128B may be increased to increase the maximum channel diameter 118. In some embodiments, the user may desire a channel diameter 118 that is smaller than the maximum channel diameter 118.The user can stop the progress of the first tab 124A and the second tab 124B anywhere along the first and second plurality of flanges 126A / 126B before the second tab 124B slides into the first recess 128A and the first tab slides into the second recess 128B.

[0060] In some embodiments, each flange on each of the first plurality of flanges 126A or the second plurality of flanges 126B may correspond to an increase in the diameter of channel 118. In some embodiments, each flange on each of the first plurality of flanges 126A and the second plurality of flanges 126B may correspond to an increased diameter of channel 118 corresponding to the scale of the French catheter. For example, in a dilator Q7QCnn / C7n7 / R / VIAI mechanical 100 including five flanges and a recess in the first and second plurality of flanges, by passing the first tab 124A over the first flange of the second plurality of flanges 126B and the second tab 124B over the first flange of the second plurality of flanges, the diameter of the channel 117 can be expanded to fit a 12 French catheter. Passing the first tab 124A over the second flange of the second plurality of flanges and the second tab 124B over the second flange of the second plurality of flanges can be expanded to fit a 13 French catheter. Securing the first tab 124A into the second recess of the second locking plate 122B and the second tab 124B into the first recess of the first locking plate 122A can expand the diameter of channel 117 to fit a 17 French catheter into it.

[0061] Figures 4A-4B illustrate a plan view of an exemplary method of dilating the mechanical dilator 100, according to several embodiments. The fulcrum 116 allows lateral movement of the first arm 104A relative to the second arm 104B to result in an increase or decrease in the diameter 117 of the channel 118, and the first side 114A and the second side 114B are moved laterally closer together or farther apart. As illustrated in Figure 4A, the first arm 104A can be configured to move laterally away from the second arm 104B. Moving the first arm 104A away from the second arm 104B reduces the diameter 117 of the channel 118 and brings the first side 114A and the second side 114B closer together laterally. In some embodiments, the mechanical dilator 100 can be configured in the closed configuration, when the first side 114A and the second side 114B are in physical contact.

[0062] As illustrated in FIG. 4B, compressing the first arm 104A and the second arm 104B laterally together increases the diameter 117 of the channel 118, breaking the physical contact between the first side 114A and the second side 114B. In some embodiments, the mechanical dilator 100 can be set to the open configuration, where the first side 114A and the second side 114B are no longer in physical contact and are separated by the maximum permissible distance. In other words, the open configuration of the mechanical dilator 100 includes the first arm 104A and the second arm 104B being compressed laterally together and the channel diameter 117 being the maximum diameter permitted by the user and the locking and stopping mechanism 120. In some embodiments, the mechanical dilator 100 can be slid into an insertion site in the closed configuration.In some embodiments, the transition of the mechanical dilator 100 between the closed and open configurations dilates the insertion site, including one or more of the surrounding tissues, as will be described in more detail later in this document. In some embodiments, the mechanical dilator can be diverted to the closed configuration by including a diverting member (e.g., a spring). In some embodiments, the mechanical dilator can be diverted to the open configuration by including a diverting element (e.g., a spring). In some embodiments, once... Q7QCnn / C7n7 / R / VIAI Once the mechanical dilator 100 has moved from the closed to the open configuration, it cannot return to the closed configuration. In some embodiments, once the mechanical dilator 100 has moved from the closed to the open configuration, it can return to the closed configuration by manually resetting the locking and stopping mechanism 120.

[0063] Figures 5A-5C illustrate an exemplary method of using a mechanical dilator 100 in a medical device insertion system 200, according to some embodiments. In some embodiments, the medical device insertion system 200 includes a guide wire 202 and a mechanical dilator 100. As illustrated in Figure 5A, the guide wire 202 can be inserted into a target area 204, through an insertion site 206. In some embodiments, once the guide wire 202 is inserted, the mechanical dilator 100, more specifically the dilator body 110, can be configured to slide over the guide wire 202 in closed position to slide-engage the insertion site 206 as illustrated in Figure 5B. More specifically, the guide cable 202 can be inserted through channel 118 and the mechanical dilator 100 can be slid over the guide cable 202.In some embodiments, the mechanical dilator 100 can be slid onto the guide wire 202 in the open configuration and then transitioned to the closed configuration before insertion into the insertion site 206. In some embodiments, as illustrated in FIG. 5C, once the mechanical dilator 100 is engaged at the insertion site 206, it can be configured to dilate the insertion site 206 by laterally compressing the first arm 104A relative to the second arm 104B, laterally expanding the first side 114A relative to the second side 114B, or simply from the closed to the open configuration. In some embodiments, the locking and stopping mechanism 120 can be configured to prevent over-dilation of the tissue surrounding the insertion site 206.

[0064] Figure 6 illustrates a flowchart of an exemplary method 300 of using the mechanical dilator 100 to position an elongated medical device, according to some embodiments. In some embodiments, method 300 includes inserting a guide wire 202 into an insertion site 206 in a target area 204 (block 302). In some embodiments, the target area 204 may include an anatomical target (e.g., a blood vessel or the like). In some embodiments, the guide wire 202 may be inserted into the insertion site 206 through an insertion needle. Method 300 further includes sliding the mechanical dilator 100, in the closed configuration, over the guide wire 202 to slidably engage the insertion site 206 (block 304). In some embodiments, the body of the dilator 110 can be slid into the insertion site 206 until a portion of the body of the dilator 110 is no longer visible.In some embodiments, the body of the 110 dilator can be slid into the insertion site until the entire body of the 110 dilator is no longer visible. In some embodiments, the mechanical dilator 100 can be slid over it. Q7QCnn / C7n7 / R / VIAI guide cable 202 in open configuration and transition to closed configuration before insertion at insertion site 206.

[0065] Method 300 further includes dilating the tissue surrounding the insertion site 206 using the mechanical dilator 100 (block 306). In some embodiments, dilating the tissue surrounding the insertion site 206 includes laterally compressing the first arm 104A relative to the second arm 104B to expand the first side 114A away from the second side 114B, thereby expanding the channel 118. Method 300 further includes configuring the locking and stopping mechanism 120 to prevent over-dilation of the insertion site 206 (block 308). In some embodiments, setting up the locking and stopping mechanism 120 includes laterally compressing a first arm 104A with respect to a second arm 104B until a first tab 124A is secured in a second recess 128B of a second locking plate 122B and a second tab 124B is secured in the first recess 128A of a first locking plate 122A.In some embodiments, setting up the locking and stopping mechanism 120 includes laterally compressing the first arm 104A with respect to the second arm 104B until the first tab 124A is secured in one of the flanges of a second plurality of flanges of the second locking plate and the second tab 124B is secured in one of the flanges of a first plurality of flanges of the first locking plate 122A.

[0066] Method 300 further includes removing the mechanical dilator 100 from the insertion site 206 (block 310). In some embodiments, removing the mechanical dilator 100 from the insertion site 206 includes removing the mechanical dilator 100 from the insertion site 206 in the open configuration. In some embodiments, Method 300 includes an optional step of sliding an elongated medical device over the guide wire 202, through a channel 118 of the mechanical dilator 100 at the insertion site 206 (block 309). In some embodiments, the elongated medical device may include a catheter or a stylet. Advantageously, inserting the mechanical dilator 100 over the guide wire 202 at the insertion site ensures that tissue dilation occurs along the path that the elongated medical device will take.

[0067] Although some specific embodiments have been described herein, and although those specific embodiments have been described in some detail, it is not intended that the specific embodiments limit the scope of the concepts provided herein. Further adaptations and / or modifications may seem appropriate to those skilled in the art, and in broader respects, these adaptations and / or modifications are also covered. Accordingly, deviations from the specific embodiments described herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A mechanical dilator, comprising: a first arm coupled to a second arm by a fulcrum, the first arm and the second arm cooperatively defining a locking and stopping mechanism configured to limit the lateral movement of the first arm with respect to the second arm; and a dilator body having a first side extending from the first arm and a second side extending from the second arm, wherein the fulcrum is configured to transfer the lateral movement of the first arm with respect to the second arm to the lateral movement of the first side with respect to the second side.

2. The mechanical dilator according to claim 1, wherein the first arm is closer to a distal end of the dilator body than the second arm.

3. The mechanical dilator according to claim 1, wherein the second arm is closer to the distal end of the dilator body than the first arm.

4. The mechanical dilator according to any of claims 1-3, wherein the first arm is laterally displaced from the second arm.

5. The mechanical dilator according to any of claims 1-4, wherein the dilator body includes a channel dividing the dilator body into a first side and a second side, the channel having a constant diameter and extending from a proximal end of each of the first arm and the second arm to a dilating tip.

6. The mechanical dilator according to any of claims 1-5, wherein the locking and stopping mechanism includes a first locking plate configured to slide into a second locking plate.

7. The mechanical dilator according to claim 6, wherein the first locking plate is coupled to the first arm and the second locking plate is coupled to the second arm.

8. The mechanical dilator according to claim 7, wherein the first locking plate and the second locking plate each include a tab, a plurality of flanges, a recess, and a stop flange.

9. The mechanical dilator according to any claim of claims 1-8, wherein the mechanical dilator can be configured to transition between an open configuration and a closed configuration.

10. The mechanical dilator according to claim 9, wherein, in the closed configuration, the first side and the second side are in physical contact. Q7QCnn / C7n7 / R / VIAI 11. The mechanical dilator according to claim 9, wherein, in the open configuration, the first side and the second side are at the maximum possible distance, the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

12. The mechanical dilator according to any of claims 1-11, wherein the dilator body is detachably coupled to the first arm and the second arm.

13. The mechanical dilator according to claim 12, wherein the dilator body is separably coupled via a press fit, a quick fit, or an interference fit.

14. The mechanical dilator according to any of claims 1-13, wherein the mechanical dilator is disposable or reusable.

15. The mechanical dilator according to any of claims 5-14, wherein the proximal ends of each of the first arm and the second arm have chamfered edges.

16. The mechanical dilator according to claim 5, wherein the tip of the dilator is sharpened to facilitate the entry of the dilator body into an insertion site.

17. A medical device insertion system comprising: a guide wire; and a mechanical dilator configured to slide on the guide wire, the mechanical dilator having a first arm coupled to a second arm by means of a fulcrum, the first arm and the second arm cooperatively defining a locking and stopping mechanism; a dilator body comprising a first side extending from the first arm and a second side extending from the second arm, a channel configured to slide on the guide wire, the channel dividing the dilator body into the first side and the second side, wherein the fulcrum is configured to translate the movement of the first arm with respect to the second arm to the lateral movement of the first side with respect to the second side.

18. The medical device insertion system according to claim 17, wherein the locking and stopping mechanism includes a first locking plate configured to slide into a second locking plate.

19. The medical device insertion system according to claim 18, wherein the first locking plate includes a first tab, a first plurality of flanges, a first recess and a first stop flange and the second locking plate includes a second tab, a second plurality of flanges, a second recess and a second stop flange.

20. The medical device insertion system according to claim 19, wherein the mechanical dilator is configured to transition from a closed configuration to an open configuration.

21. The medical device insertion system according to claim 20, wherein, in the closed configuration, the first side and the second side are in physical contact.

22. The medical device insertion system according to claim 20, wherein, in the open configuration, the first side and the second side are at the maximum possible distance, the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

23. The medical device insertion system according to claim 21, wherein the mechanical dilator slides over the guide wire in the closed configuration.

24. The medical device insertion system according to any of claims 17-23, wherein the channel includes a constant diameter and extends from a proximal end of each of the first arm and the second arm to a dilating tip.

25. The medical device insertion system according to claim 24, wherein the tip of the dilator is sharpened to facilitate the entry of the dilator body into an insertion site.

26. A method of using a mechanical dilator to dilate an insertion site comprising: inserting a guide wire into an insertion site; sliding the mechanical dilator over the guide wire into the insertion site, the mechanical dilator having a first arm coupled to a second arm by a fulcrum, the first arm and the second arm cooperatively defining a locking and stopping mechanism configured to limit the lateral movement of the first arm with respect to the second arm; the mechanical dilator having a dilator body comprising a first side extending from the first arm and a second side extending from the second arm, a channel dividing the dilator body into the first side and the second side, wherein the fulcrum is configured to transfer the lateral movement of the first arm with respect to the second arm to the lateral movement of the first side with respect to the second side;dilate the tissue surrounding the insertion site by moving the mechanical dilator from a closed to an open configuration; and withdraw the mechanical dilator from the guide wire.

27. The method according to claim 26, wherein the locking and stopping mechanism includes a first locking plate coupled to the first arm and a second locking plate coupled to the second arm.

28. The method according to claim 27, wherein the first locking plate includes Q7QCnn / C7n7 / R / VIAI a first tab, a first plurality of flanges, a first recess and a first stop flange and the second locking plate includes a second tab, a second plurality of flanges, a second recess and a second stop flange.

29. The method according to any of claims 26 to 28, wherein, in the closed configuration, the first side and the second side are in physical contact with each other.

30. The method according to any of claims 26-29, wherein, in the open configuration, the first side and the second side are at the maximum possible distance, the first tab of the first locking plate is secured in the second recess of the second locking plate and the second tab of the second locking plate is secured in the first recess of the first locking plate.

31. The method according to any of claims 26-30, wherein the dilation of the tissue surrounding the insertion site includes configuring the locking and stopping mechanism to prevent excessive dilation of the insertion site.

32. The method according to any of claims 26-31, wherein dilating the tissue surrounding the insertion site includes sliding an elongated medical device over the guide wire through the channel of the mechanical dilator toward the insertion site, when the mechanical dilator is in the open configuration.

33. The method according to claim 32, wherein the elongated medical device includes a catheter.

34. The method according to any of claims 26-33, wherein sliding the mechanical dilator over the guide cable includes sliding the mechanical dilator over the guide cable in the open configuration.

35. The method according to any of claims 26-33, wherein sliding the mechanical dilator over the guide cable includes sliding the mechanical dilator over the guide cable in the closed configuration.

36. The method according to claim 34, wherein sliding the mechanical dilator over the guide wire includes transitioning the mechanical dilator from the open configuration to the closed configuration before insertion at the insertion site.

Images