Mechanical expander

Abstract

A mechanical dilator 100 is disclosed, which can include a first arm 104A coupled to a second arm 104B by a fulcrum 116, the first arm and second arm cooperatively defining a locking and stopping mechanism configured to limit lateral movement of the first arm relative to the second arm. The mechanical dilator can further include a dilator body 110 having a first side extending from the first arm and a second side extending from the second arm. The fulcrum is configured to translate lateral movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side.

Description

Technical Field

[0001] The present invention relates to medical devices, and more particularly to mechanical dilators.

Background Art

[0002] During the placement procedure of a medical device, the tissue around the insertion site must be expanded or enlarged so that a medical device with a cross-sectional diameter larger than the insertion site can be inserted. The method of expanding the tissue may include multiple steps using multiple instruments. Further, the clinician must visually determine how much the tissue around the insertion site should be expanded in order to facilitate the insertion of the medical device into the insertion site. Visual judgment may lead to over-expansion of the tissue. It would be beneficial for both the clinician and the patient if the tissue around the insertion site could be more accurately expanded with a single instrument. Apparatus, systems, and methods for addressing the above are disclosed herein.

Summary of the Invention

[0003] Disclosed herein is a mechanical dilator, which includes a first arm coupled to a second arm by a fulcrum, wherein the first arm and the second arm cooperate with a lock and stop mechanism configured to limit the lateral movement of the first arm with respect to the second arm to define a first arm, and an expander body having a first side extending from the first arm and a second side extending from the second arm, and the fulcrum is configured to convert the lateral movement of the first arm with respect to the second arm into 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. In some embodiments, the first arm is offset laterally from the second arm.

[0005] In some embodiments, the expander body includes a channel that divides the expander body into a first side and a second side. In some embodiments, the channel has a consistent diameter and extends from the proximal ends of the first and second arms to the tip of the expander.

[0006] In some embodiments, the locking and stopping mechanism includes a first locking plate configured to slidably engage with a second locking plate. In some embodiments, the first locking plate is coupled to the first arm, and the second locking plate is coupled to the second arm.

[0007] In some embodiments, the first locking plate and the second locking plate each include a tab, a plurality of protrusions, a recess, and a stop protrusion. In some embodiments, the mechanical expander may be configured to transition between an open configuration and a closed configuration.

[0008] In some embodiments, in a closed configuration, the first side and the second side are in physical contact. In some embodiments, in an open configuration, the first side and the second side are separated by the maximum possible distance, the first tab of the first locking plate is fixed to the second recess of the second locking plate, and the second tab of the second locking plate is fixed to the first recess of the first locking plate.

[0009] In some embodiments, the expander body is removably coupled to the first and second arms by press-fit, snap-fit, or interlocking fit. In some embodiments, the mechanical expander is disposable or reusable.

[0010] In some embodiments, the proximal ends of the first and second arms each include a chamfered edge. Also disclosed herein are medical device insertion systems comprising a guidewire and a mechanical dilator configured to slide along the guidewire. In some embodiments, the mechanical dilator has a first arm coupled to a second arm by a pivot point, the first and second arms cooperating to define a locking and stopping mechanism. The mechanical dilator also comprises a dilator body having a first side extending from the first arm and a second side extending from the second arm, and a channel configured to slide along the guidewire, the channel dividing the dilator body into the first and second sides, the pivot point configured to convert the movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side.

[0011] In some embodiments, the locking and stopping mechanism comprises a first locking plate configured to slidably engage with a second locking plate. The first locking plate has a first tab, a first set of protrusions, a first recess, and a first stopping protrusion, and the second locking plate has a second tab, a second set of protrusions, a second recess, and a second stopping protrusion.

[0012] In some embodiments, the mechanical expander is configured to transition from a closed configuration to an open configuration. In some embodiments, the closing configuration includes a first side and a second side that are in physical contact.

[0013] In some embodiments, in an open configuration, the first side and the second side are separated by the maximum possible distance, the first tab of the first locking plate is fixed to the second recess of the second locking plate, and the second tab of the second locking plate is fixed to the first recess of the first locking plate.

[0014] In some embodiments, the mechanical expander slides on the guide wire in a closed configuration or on the guide wire in an open configuration. In some embodiments, the channel has a constant diameter.

[0015] In some embodiments, the tip of the dilator is sharpened to facilitate the entry of the dilator body into the insertion site. Furthermore, this specification also discloses a method for dilating an insertion site using a mechanical dilator, comprising: inserting a guidewire into the insertion site; sliding the mechanical dilator along the guidewire toward the insertion site; dilating the tissue surrounding the insertion site by moving the mechanical dilator from a closed configuration to an open configuration; and removing the mechanical dilator from the guidewire. In some embodiments, the mechanical expander comprises a first arm coupled to a second arm by a pivot point, the first and second arms cooperating to define a locking and stopping mechanism configured to restrict the lateral movement of the first arm relative to the second arm, and the mechanical expander comprises an expander body having a first side portion extending from the first arm and a second side portion extending from the second arm, and a channel dividing the expander body into the first and second side portions, the pivot point configured to convert the lateral movement of the first arm relative to the second arm into the lateral movement of the first side portion relative to the second side portion.

[0016] In some embodiments, the locking and stopping mechanism includes a first locking plate coupled to a first arm and a second locking plate coupled to a second arm. In some embodiments, the first locking plate includes a first tab, a first set of protrusions, a first recess, and a first stop protrusion, and the second locking plate includes a second tab, a second set of protrusions, a second recess, and a second stop protrusion.

[0017] In some embodiments, in a closed configuration, the first side and the second side are in physical contact with each other. In some embodiments, in an open configuration, the first side and the second side are separated by the maximum possible distance, the first tab of the first locking plate is fixed to the second recess of the second locking plate, and the second tab of the second locking plate is fixed to the first recess of the first locking plate.

[0018] In some embodiments, expanding the tissue surrounding the insertion site includes configuring a locking and stopping mechanism to prevent excessive expansion of the insertion site. In some embodiments, expanding the tissue surrounding the insertion site involves sliding a slender medical device through a channel in the mechanical dilator onto a guide wire into the insertion site when the mechanical dilator is in an open configuration.

[0019] In some embodiments, the elongated medical device includes a catheter. In some embodiments, sliding the mechanical expander on the guide wire includes sliding the mechanical expander on the guide wire in an open configuration.

[0020] In some embodiments, sliding the mechanical expander on the guide wire includes sliding the mechanical expander on the guide wire in a closed configuration. In some embodiments, sliding the mechanical expander on a guide wire includes transitioning the mechanical expander from an open configuration to a closed configuration before insertion into the insertion site.

[0021] These and other features of the concepts provided herein will become more apparent to those skilled in the art in consideration of the accompanying drawings and the following description, which disclose in more detail specific embodiments of such concepts.

[0022] A more specific description of the present disclosure is provided by reference to its specific embodiments shown in the accompanying drawings. These drawings show only typical embodiments of the invention and thus should not be considered as limiting its scope. Exemplary embodiments of the invention are described and explained with additional specificity and detail by using the accompanying drawings.

Brief Description of the Drawings

[0023] [Figure 1A] A side view of a mechanical dilator according to some embodiments is shown. [Figure 1B] A perspective view of a mechanical dilator according to some embodiments is shown. [Figure 2A] A perspective view of a dilator body according to some embodiments is shown. [Figure 2B] A plan view of the proximal end of a dilator body including a channel according to some embodiments is shown. [Figure 3A] A perspective view of a locking and stopping mechanism coupled to a mechanical dilator according to some embodiments is shown. [Figure 3B] A cross-sectional view of a locking and stopping mechanism coupled to a mechanical dilator according to some embodiments is shown. [Figure 4A] A plan view of an exemplary method of expanding a mechanical dilator according to some embodiments is shown. [Figure 4B] A plan view of an exemplary method of expanding a mechanical dilator according to some embodiments is shown. [Figure 5A] A perspective view of an exemplary method of using a mechanical dilator in a medical device insertion system according to some embodiments is shown. [Figure 5B] A perspective view of an exemplary method of using a mechanical dilator in a medical device insertion system according to some embodiments is shown. [Figure 5C] A perspective view of an exemplary method of using a mechanical dilator in a medical device insertion system according to some embodiments is shown. [Figure 6]A flowchart illustrates an exemplary method of expanding the tissue surrounding an insertion site using a mechanical dilator, according to several embodiments. [Modes for carrying out the invention]

[0024] Before disclosing some specific embodiments in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that are easily separable from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0025] With regard to the terms used herein, it should be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, features or steps labeled "1st," "2nd," and "3rd" do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Indications such as "left," "right," "up," "down," "front," and "back" are for convenience and do not imply, for example, a specific fixed position, direction, orientation, etc. Instead, such indications are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural subjects unless explicitly indicated in the context.

[0026] With respect to “proximal,” for example, the “proximal portion” or “proximal end portion” of a mechanical dilator disclosed herein includes the portion of the mechanical dilator that is intended to be near the clinician when the mechanical dilator is used on a patient. Similarly, for example, the “proximal length” of a mechanical dilator includes the length of the mechanical dilator that is intended to be near the clinician when the mechanical dilator is used on a patient. For example, the “proximal end” of a mechanical dilator includes the end of the mechanical dilator that is intended to be near the clinician when the mechanical dilator is used on a patient. The proximal portion, proximal end portion, or proximal length of a mechanical dilator may include the proximal end of the mechanical dilator. However, the proximal portion, proximal end portion, or proximal length of a mechanical dilator does not have to include the proximal end of the mechanical dilator. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a mechanical dilator is not the terminal portion or terminal length of the mechanical dilator.

[0027] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a mechanical dilator disclosed herein includes the portion of the mechanical dilator that is intended to be near or within the patient when the mechanical dilator is used on a patient. Similarly, for example, the “distal length” of a mechanical dilator includes the length of the mechanical dilator that is intended to be near or within the patient when the mechanical dilator is used on a patient. For example, the “distal end” of a mechanical dilator includes the end of the mechanical dilator that is intended to be near or within the patient when the mechanical dilator is used on a patient. The distal portion, distal end portion, or distal length of a mechanical dilator may include the distal end of the mechanical dilator. However, the distal portion, distal end portion, or distal length of a mechanical dilator does not necessarily include the distal end of the mechanical dilator. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a mechanical dilator is not the terminal portion or terminal length of the mechanical dilator.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. Figure 1A shows a side view of a mechanical expander 100 according to several embodiments. In some embodiments, the mechanical expander 100 includes a first arm 104A and a second arm 104B. In some embodiments, the expander body 110 extends from the distal ends of the first arm 104A and the second arm 104B. In some embodiments, the expander body 110 extends to the expander tip 112. In some embodiments, the first arm 104A and the second arm 104B cooperate to define a locking and stopping mechanism 120 which may be configured to restrict the lateral movement of the first arm 104A relative to the second arm 104B. As shown in Figure 1A, in some embodiments, the first arm 104A may be closer to the distal end of the expander body 110 than the second arm 104B. In some embodiments, the second arm 104B may be closer to the distal end of the expander body 110 than the first arm 104A. In some embodiments, the first arm 104A may be laterally offset from the second arm 104B.

[0029] Figure 1B shows perspective views of the mechanical expander 100 according to several embodiments. In some embodiments, the mechanical expander 100 may be configured to transition between a closed configuration and an open configuration. In some embodiments, the first arm 104A may be compressed toward the second arm 104B. In some embodiments, when the first arm 104A and the second arm 104B are compressed together, a portion of the first arm 104A contacts a portion of the second arm 104B. In some embodiments, a locking and stopping mechanism 120 may be positioned where the first arm 104A contacts the second arm 104B. In some embodiments, the shapes of the first arm 104A and the second arm 104B may include rectangular prisms, tapered rectangular prisms, rounded rectangular prisms, cubes, cylindrical shapes, pentagonal prisms, hexagonal prisms, and combinations thereof. In some embodiments, the first arm 104A and the second arm 104B may be connected to each other by a pivot point 116 extending between them. In some embodiments, the pivot point 116 converts the lateral movement of the first arm 104A and the second arm 104B into movement of the expander body 110, which will be described in more detail herein. In some embodiments, the expander body 110 is bifurcated by a channel 118.

[0030] Figure 2A shows a perspective view of the expander body 110 according to several embodiments. As shown in Figure 2A, the channel 118 divides the expander body 110 into two equal sides, namely, a first side 114A extending from a first arm 104A and a second side 114B extending from a second arm 104B. The expander body 110 may be configured to expand or contract laterally through the lateral movement of the first arm 104A and the second arm 104B. In some embodiments, the expander body 110 terminates at an expander tip 112, which may be tapered. In some embodiments, the expander tip 112 may be sharpened to facilitate the entry of the expander body 110 into the insertion site. In some embodiments, the expander body 110 is cylindrical. However, other shapes are also possible. Advantageously, the cylindrical shape of the expander body 110 allows for uniform circumferential expansion of the tissue surrounding the insertion site. In some embodiments, uniform circumferential expansion reduces skin sagging and ensures a consistent size of the insertion site, thus ensuring consistent placement of the medical device.

[0031] In one embodiment, the expander body 110 may be detachably coupled to the first arm 104A and the second arm 104B. In one embodiment, the expander body 110 may be attached to the first arm 104A and the second arm 104B by press-fitting, snap-fitting, or crimp-fitting. In this embodiment, the mechanical expander 100 and the expander body 110 may be provided separately, and the expander body 110 may then be coupled to the first arm 104A and the second arm 104B before use. In some embodiments, various expander bodies 110 having channels 118 with different diameters 117 may be detachably coupled to the mechanical expander 100. By detachably coupling various expander bodies 110 to the mechanical expander 100, the user can select the desired expansion of the insertion site immediately before use. In some embodiments, the mechanical expander 100, including the expander body 110, may be made of metal (e.g., steel, aluminum, etc.), plastic (e.g., polyester, polyethylene, polyvinyl chloride, polypropylene, etc.), or a combination thereof. In some embodiments, the mechanical expander 100 or its parts, including the expander body 110, may be configured to be reusable or disposable.

[0032] Figure 2B shows plan views of the first arm 104A and the second arm 104B of the mechanical expander 100 according to several embodiments. In some embodiments, the channel 118 extends from the proximal side of the mechanical expander 100 to the expander tip 112. In some embodiments, the channel 118 may be configured to have a constant diameter 117 through the expander body 110. In some embodiments, the proximal side of the channel 118 may include a chamfered edge configured to allow a medical device to slide through it. As the expander body 110 expands laterally, the diameter 117 of the channel 118 can also expand. As the expander body 110 expands laterally, the diameter 117 of the channel 118 can also expand uniformly. In some embodiments, the diameter 117 of the channel 118 may expand to be larger than the cross-sectional diameter of an elongated medical device, allowing a portion of the elongated medical device to move through the channel 118.

[0033] Figure 3A shows a perspective view of the first locking plate 122A of the locking and stopping mechanism 120 according to several embodiments. In some embodiments, the mechanical expander 100 may be configured to include a portion of the locking and stopping mechanism 120 on a first arm 104A and a portion of the locking and stopping mechanism 120 on a second arm 104B. In some embodiments, the locking and stopping mechanism 120 includes a first locking plate 122A which can be configured to slidably engage with the second locking plate 122B. In some embodiments, the first locking plate 122A includes a first tab 124A, a first set of protrusions 126A projecting from the first locking plate 122A, a first recess 128A, and a first stopping protrusion 130A. In some embodiments, the first locking plate 122A may be configured to slidably engage with the second tab 124B. In some embodiments, the mechanical expander 100 may include a first locking plate 122A coupled to a first arm 104A and a second tab 124B coupled to a second arm 104B.

[0034] Figure 3B shows cross-sectional views of a first locking plate 122A and a second locking plate 122B of a locking and stopping mechanism 120 coupled to a mechanical expander 100, according to several embodiments. In some embodiments, the second locking plate 122B includes a second tab 124B, a second set of protrusions 126B projecting from the second locking plate 122B, a second recess 128B, and a second stopping protrusion 130B. In some embodiments, the first locking plate 122A may be coupled to a first arm 104A, and the second locking plate 122B may be coupled to a second arm 104B. When the first arm 104A and the second arm 104B are pushed laterally toward each other, the first tab 124A slidably engages with the second plurality of protrusions 126B, and the second tab 124B slidably engages with the first plurality of protrusions 126A. The first arm 104A and the second arm 104B may be pushed laterally toward each other until the first tab 124A is fixed in the second recess 128B, and the second tab 124B is fixed in the first recess 128A. The first stop protrusion 130A prevents the second tab 124B and the second arm 104B from moving further laterally, and the second stop protrusion 130B prevents the first tab 124A and the first arm 104A from moving further laterally. The first stop ridge 130A and the first recess 128A, and the second stop ridge 130B and the second recess 128B, can be configured to open the channel 118 to its maximum possible diameter. In some embodiments, the first plurality of ridges 126A may be configured to have the same number of ridges as the second plurality of ridges 126B. In some embodiments, each ridge in the first plurality of ridges 126A may be configured to have a corresponding ridge in the second plurality of ridges 126B.

[0035] In one embodiment, as the first tab 124A passes through each of the second plurality of protrusions 126B, and the second tab 124B passes through each of the first plurality of protrusions 126A, the user can be notified of the progress of the first tab 124A on the second plurality of protrusions 126B and the second tab 124B on the second plurality of protrusions 126B by an audible sound (e.g., a click, a pop). In this embodiment, the audible sounds of the first tab 124A passing through each of the second plurality of protrusions 126B and the second tab 124B passing through each of the first plurality of protrusions 126A can correspond to an incremental increase in the expansion of the expander body 110. In some embodiments, the locking and stopping mechanism 120 may have a visual indicator showing the progress of the first tab 124A on the second plurality of protrusions 126B and the second tab on the second plurality of protrusions 126B. In one embodiment, the visual indicator may include each protrusion of the first plurality of protrusions 126A and each corresponding protrusion of the second plurality of protrusions 126B, having different colors corresponding to a particular diameter of the channel 118. In this embodiment, the user can visually determine the progress of the expansion of the expander body 110 and the diameter 117 of the channel 118. In some embodiments, a combination of audible sound and a visual indicator showing the progress of the first tab 124A passing through each of the second plurality of protrusions 126B and the second tab 124B passing through each of the first plurality of protrusions 126A can provide the user with two different mechanisms for determining the progress of expansion of the expander body 110 and the diameter 117 of the channel 118.

[0036] In some embodiments, the locking and stopping mechanism 120 can be pre-configured for the maximum diameter 117 of the channel 118 or the maximum distance between the first side 114A and the second side 114B. For example, the maximum diameter 117 of the channel 118 may be configured to be greater than the diameter of the elongated medical device selected by the user. In some embodiments, the number of protrusions in the first plurality of protrusions 126A in front of the first recess 128A, and the number of protrusions in the second plurality of protrusions 126B in front of the second recess 128B, can be increased or configured to increase the maximum diameter of the channel 118. In some embodiments, the user may also desire a channel 118 diameter smaller than the maximum diameter of the channel 118. The user can stop the advance of the first tab 124A and the second tab 124B at any point along the first and second protrusions 126A / 126B before the second tab 124B slidably engages with the first recess 128A and the first tab slidably engages with the second recess 128B.

[0037] In some embodiments, each of the first set of protrusions 126A or the second set of protrusions 126B can correspond to an increase in the diameter of the channel 118. In some embodiments, each of the first set of protrusions 126A and the second set of protrusions 126B can correspond to an increased diameter of the channel 118 that matches a French catheter scale. For example, in a mechanical expander 100 having five protrusions and one recess in the first set of protrusions and the second set of protrusions, the channel diameter 117 can be expanded to fit a 4 mm (12 French) catheter by passing the first tab 124A over the first protrusion of the second set of protrusions 126B and the second tab 124B over the first protrusion of the second set of protrusions. By passing the first tab 124A over the second of the second set of protrusions and the second tab 124B over the second of the second set of protrusions, the diameter 117 of the channel can be expanded to accommodate a 4.3 mm (13 French) catheter. By fixing the first tab 124A to the second recess of the second locking plate 122B and the second tab 124B to the first recess of the first locking plate 122A, the diameter 117 of the channel can be expanded to accommodate a 5.7 mm (17 French) catheter.

[0038] Figures 4A and 4B are plan views illustrating exemplary methods of expanding the mechanical expander 100 according to several embodiments. The pivot point 116 converts the lateral movement of the first arm 104A relative to the second arm 104B into an increase or decrease in the diameter 117 of the channel 118, causing the first side 114A and the second side 114B to move laterally closer together or further apart. As shown in Figure 4A, the first arm 104A may be configured to move laterally away from the second arm 104B. When the first arm 104A is moved away from the second arm 104B, the diameter 117 of the channel 118 decreases, causing the first side 114A and the second side 114B to move laterally together. In some embodiments, the mechanical expander 100 can be in a closed configuration when the first side 114A and the second side 114B are in physical contact.

[0039] As shown in Figure 4B, when the first arm 104A and the second arm 104B are pushed laterally toward each other, the diameter 117 of the channel 118 increases, and physical contact between the first side 114A and the second side 114B is broken. In some embodiments, the mechanical expander 100 can be in an open configuration when the first side 114A and the second side 114B are not in physical contact and are separated by a maximum allowed distance. In other words, the open configuration of the mechanical expander 100 includes when the first arm 104A and the second arm 104B are pushed laterally toward each other and the diameter 117 of the channel is the maximum diameter allowed by the user and the locking and stopping mechanism 120. In some embodiments, the mechanical expander 100 may slide within the insertion portion in a closed configuration. In some embodiments, the mechanical expander 100 expands an insertion site, including one or more of the surrounding tissue, by transitioning between a closed configuration and an open configuration, as described in more detail herein. In some embodiments, the mechanical expander may be biased to a closed configuration by including a biasing member (e.g., a spring). In some embodiments, the mechanical expander may be biased to an open configuration by including a biasing member (e.g., a spring). In some embodiments, the mechanical expander 100 cannot be returned to a closed configuration after transitioning from a closed configuration to an open configuration. In some embodiments, the mechanical expander 100 can be returned to a closed configuration after transitioning from a closed configuration to an open configuration by manually resetting the locking and stopping mechanism 120.

[0040] Figures 5A-5C illustrate exemplary methods of using a mechanical dilator 100 in a medical device insertion system 200 according to several embodiments. In some embodiments, the medical device insertion system 200 includes a guide wire 202 and a mechanical dilator 100. As shown 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 on the guide wire 202 in a closed configuration and slidably engage with the insertion site 206, as shown in Figure 5B. More specifically, the guide wire 202 can be inserted through a channel 118, and the mechanical dilator 100 can slide on the guide wire 202. In some embodiments, the mechanical dilator 100 can slide on the guide wire 202 in an open configuration and then transition to a closed configuration before insertion into the insertion site 206. In some embodiments, as shown in Figure 5C, the mechanical expander 100 may be configured to expand the insertion site 206 by, upon engagement with the insertion site 206, pressing the first arm 104A laterally against the second arm 104B and expanding the first side 114A laterally against the second side 114B, or, simply put, expanding the insertion site 206 from a closed configuration to an open configuration. In some embodiments, a locking and stopping mechanism 120 may be configured to prevent excessive expansion of the tissue surrounding the insertion site 206.

[0041] Figure 6 shows a flowchart of an exemplary method 300 using a mechanical dilator 100 to position a long medical device, according to several embodiments. In some embodiments, method 300 includes inserting a guidewire 202 into an insertion site 206 within a target region 204 (block 302). In some embodiments, the target region 204 may include an anatomical target (e.g., a blood vessel). In some embodiments, the guidewire 202 can be inserted into the insertion site 206 through an insertion needle. Method 300 further includes sliding a closed-configuration mechanical dilator 100 on the guidewire 202 to slidably engage with the insertion site 206 (block 304). In some embodiments, the dilator body 110 can be slid within the insertion site 206 until a portion of the dilator body 110 is no longer visible. In some embodiments, the dilator body 110 can be slid within the insertion site until the entire dilator body 110 is no longer visible. In some embodiments, the mechanical expander 100 can slide along the guide wire 202 in an open configuration and transition to a closed configuration before insertion into the insertion site 206.

[0042] Method 300 further includes expanding the tissue around the insertion site 206 using a mechanical expander 100 (block 306). In some embodiments, expanding the tissue around the insertion site 206 includes pressing the first arm 104A laterally against the second arm 104B to expand the first side 114A away from the second side 114B and expand the channel 118. Method 300 further includes configuring a locking and stopping mechanism 120 to prevent over-expansion of the insertion site 206 (block 308). In some embodiments, configuring the locking and stopping mechanism 120 includes pressing the first arm 104A laterally against the second arm 104B until the first tab 124A is secured in the second recess 128B of the second locking plate 122B and the second tab 124B is secured in the first recess 128A of the first locking plate 122A. In some embodiments, configuring the locking and stopping mechanism 120 includes pressing the first arm 104A laterally against the second arm 104B until the first tab 124A is fixed to one of a second plurality of protrusions on the second locking plate and the second tab 124B is fixed to one of a first plurality of protrusions on the first locking plate 122A.

[0043] 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 an open configuration. In some embodiments, Method 300 includes an optional step (block 309) of sliding a slender medical device into the insertion site 206 through the channel 118 of the mechanical dilator 100 on the guidewire 202. In some embodiments, the slender medical device may include a catheter or a stylet. Advantageously, inserting the mechanical dilator 100 to the insertion site on the guidewire 202 ensures that tissue dilation occurs along the path taken by the slender medical device.

[0044] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be obvious to those skilled in the art, and in broader embodiments, these adaptations and / or modifications are also encompassed. Thus, one can deviate from any particular embodiment disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A mechanical expander, A first arm is connected to a second arm by a pivot point, the pivot point extending between the first arm and the second arm, and the first arm and the second arm cooperate to define a locking and stopping mechanism configured to restrict the lateral movement of the first arm relative to the second arm, the lateral direction being the direction intersecting the direction in which the pivot point extends, An expander body having a channel, wherein the channel divides the expander body into a first side and a second side, the first side extending from a first arm, and the second side extending from a second arm, comprising: The pivot point is configured to convert the lateral movement of the first arm relative to the second arm into the lateral movement of the first side relative to the second side. The mechanical expander is configured to transition between an open configuration in which the first side and the second side do not physically contact each other and a closed configuration in which the first side and the second side are physically in contact. The locking and stopping mechanism includes a first locking plate configured to slidably engage with a second locking plate, A mechanical expander wherein the locking and stopping mechanism is configured such that the mechanical expander cannot be returned to the closed configuration after it has transitioned from the closed configuration to the open configuration.

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

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

4. The mechanical expander according to any one of claims 1 to 3, wherein the first arm is offset laterally from the second arm.

5. The mechanical expander according to any one of claims 1 to 4, wherein the channel has a constant diameter and extends from the proximal ends of the first arm and the second arm to the tip of the expander.

6. The mechanical expander according to claim 1, wherein the first locking plate is coupled to the first arm and the second locking plate is coupled to the second arm.

7. The mechanical expander according to claim 6, wherein each of the first locking plate and the second locking plate has a tab, a plurality of protrusions, a recess and a stop protrusion.

8. The mechanical expander according to any one of claims 1 to 7, wherein in the open configuration, the first side and the second side are separated by the maximum possible distance, the first tab of the first locking plate is fixed to the second recess of the second locking plate, and the second tab of the second locking plate is fixed to the first recess of the first locking plate.

9. The mechanical expander according to any one of claims 1 to 8, wherein the expander body is detachably coupled to the first arm and the second arm.

10. The mechanical expander according to claim 9, wherein the expander body is removably coupled to the first arm and the second arm by press-fit, snap-fit, or interlocking fit.

11. A mechanical expander according to any one of claims 1 to 10, wherein the mechanical expander is disposable or reusable.

12. The mechanical expander according to any one of claims 5 to 11, wherein the proximal ends of the first arm and the second arm each have chamfered edges.

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

14. A medical device insertion system, Guide wire and A mechanical expander configured to slide along a guide wire, having a first arm connected to a second arm by a pivot point, the pivot point extending between the first arm and the second arm, and the first arm and the second arm cooperating to define a locking and stopping mechanism, An expander body comprising a first side portion extending from a first arm and a second side portion extending from a second arm, and a channel configured to slide on a guide wire, wherein the channel divides the expander body into a first side portion and a second side portion, The pivot point is configured to convert the movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side, and the lateral direction is a direction intersecting the direction in which the pivot point extends. The mechanical expander is configured to transition from a closed configuration in which the first side and the second side are in physical contact to an open configuration in which the first side and the second side are not in physical contact. The locking and stopping mechanism includes a first locking plate configured to slidably engage with a second locking plate, A medical device insertion system wherein the locking and stopping mechanism is configured such that the mechanical expander cannot be returned to the closed configuration after it has transitioned from the closed configuration to the open configuration.

15. The medical device insertion system according to claim 14, wherein the first locking plate has a first tab, a first plurality of protrusions, a first recess, and a first stop protrusion, and the second locking plate has a second tab, a second plurality of protrusions, a second recess, and a second stop protrusion.

16. The medical device insertion system according to claim 14 or 15, wherein, in the open configuration, the first side and the second side are separated by the maximum possible distance, the first tab of the first locking plate is fixed to the second recess of the second locking plate, and the second tab of the second locking plate is fixed to the first recess of the first locking plate.

17. The medical device insertion system according to claim 14 or 15, wherein the mechanical expander slides on the guide wire in the closed configuration.

18. The medical device insertion system according to any one of claims 14 to 17, wherein the channel has a constant diameter and extends from the proximal ends of the first arm and the second arm to the tip of the expander.

19. The medical device insertion system according to claim 18, wherein the tip of the expander is tapered to facilitate the entry of the expander body into the insertion site.

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