Mechanical dilator and medical device insertion system

Abstract

The present application relates to mechanical dilators and medical device insertion systems, which can include a first arm coupled to a second arm by a fulcrum, the first arm and the second arm cooperatively defining a locking and detent mechanism configured to limit lateral movement of the first arm relative to the second arm. The mechanical dilator can 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 convert lateral movement of the first arm relative to the second arm to lateral movement of the first side relative to the second side.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Patent Application No. 63 / 113,719, filed November 13, 2020, which is incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to mechanical expanders and medical device insertion systems. Background Technology

[0004] During medical device placement, the tissue surrounding the insertion site must be expanded or extended to allow for the insertion of a medical device with a cross-sectional diameter larger than the insertion site. This expansion of tissue may involve multiple steps using multiple instruments. Furthermore, clinicians must visually determine how far the tissue surrounding the insertion site must be expanded to facilitate insertion of the medical device. Visual determination can lead to over-expansion of the tissue. Being able to more precisely expand the tissue surrounding the insertion site using only a single instrument would be beneficial for both clinicians and patients. This article discloses an apparatus, system, and method for addressing these problems. Summary of the Invention

[0005] This document discloses a mechanical dilator comprising: a first arm connected to a second arm via a fulcrum, the first and second arms cooperatively defining a locking and stopping mechanism configured to restrict lateral movement of the first arm relative 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 convert lateral movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side.

[0006] In some implementations, the first arm is closer to the distal end of the expander body than the second arm, or the second arm is closer to the distal end of the expander body than the first arm.

[0007] In some implementations, the first arm is offset laterally from the second arm.

[0008] In some embodiments, the expander body includes a channel that bisects the expander body into a first side and a second side. In some embodiments, the channel has a uniform diameter and extends from the proximal end of each of the first and second arms to the expander tip.

[0009] In some implementations, the locking and stopping mechanism includes a first locking plate configured to slidably engage with the second locking plate.

[0010] In some implementations, a first locking plate is coupled to a first arm and a second locking plate is coupled to a second arm.

[0011] In some implementations, both the first locking plate and the second locking plate include tabs, multiple ridges, recesses, and stop ridges.

[0012] In some implementations, the mechanical expander can be configured to switch between an open structure and a closed structure.

[0013] In some implementations, in a closed configuration, the first side and the second side are in physical contact.

[0014] In some embodiments, in the opening 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 in the second recess of the second locking plate, and the second tab of the second locking plate is fixed in the first recess of the first locking plate.

[0015] In some implementations, the expander body is detachably connected to the first and second arms via press-fit, snap-fit, or interference fit.

[0016] In some implementations, the mechanical expander is either disposable or reusable.

[0017] In some implementations, the proximal end of each of the first and second arms includes a chamfered edge.

[0018] This document also discloses a medical device insertion system including a guidewire and a mechanical dilator configured to slide on the guidewire. In some embodiments, the mechanical dilator includes a first arm connected to a second arm via a pivot, the first and second arms cooperatively defining a locking and stop mechanism. The mechanical dilator also includes a dilator body including a first side extending from the first arm and a second side extending from the second arm and including a channel configured to slide on the guidewire, the channel dividing the dilator body into the first side and the second side, wherein the pivot is configured to convert movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side.

[0019] In some embodiments, the locking and stopping mechanism includes a first locking plate configured to slidably engage a second locking plate. The first locking plate includes a first tab, a plurality of first ridges, a first recess, and a first stop ridge, and the second locking plate includes a second tab, a plurality of second ridges, a second recess, and a second stop ridge.

[0020] In some implementations, the mechanical expander is configured to change from a closed configuration to an open configuration.

[0021] In some implementations, the closure structure includes a first side and a second side in physical contact.

[0022] In some embodiments, in the opening configuration, the first side and the second side are separated by the maximum possible distance, and the first tab of the first locking plate is fixed in the second recess of the second locking plate, while the second tab of the second locking plate is fixed in the first recess of the first locking plate.

[0023] In some implementations, the mechanical dilator slides on the guidewire in a closed configuration, or in an open configuration.

[0024] In some implementations, the channel comprises a consistent diameter.

[0025] In some implementations, the tip of the dilator is sharp to facilitate the insertion of the dilator body into the insertion site.

[0026] This document also discloses a method for expanding an insertion site using a mechanical dilator, comprising inserting a guidewire into the insertion site, sliding the mechanical dilator on the guidewire to enter the insertion site, expanding the tissue around 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 dilator includes a first arm connected to a second arm via a pivot, the first and second arms cooperatively defining a locking and stopping mechanism configured to restrict lateral movement of the first arm relative to the second arm; the mechanical dilator has a dilator body including a first side extending from the first arm and a second side extending from the second arm and including a channel dividing the dilator body into the first side and the second side, wherein the pivot is configured to convert lateral movement of the first arm relative to the second arm into lateral movement of the first side relative to the second side.

[0027] In some implementations, the locking and stopping mechanism includes a first locking plate connected to the first arm and a second locking plate connected to the second arm.

[0028] In some embodiments, the first locking plate includes a first tab, a plurality of first ridges, a first recess, and a first stop ridge, and the second locking plate includes a second tab, a plurality of second ridges, a second recess, and a second stop ridge.

[0029] In some implementations, in a closed configuration, the first side and the second side are in physical contact with each other.

[0030] In some embodiments, in the opening 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 in the second recess of the second locking plate, and the second tab of the second locking plate is fixed in the first recess of the first locking plate.

[0031] In some implementations, expanding the tissue around the insertion site includes configuring locking and stop mechanisms to prevent excessive expansion of the insertion site.

[0032] In some implementations, expanding the tissue around the insertion site includes sliding an elongated medical device along a guidewire through the channel of the mechanical dilator into the insertion site when the mechanical dilator is in an open configuration.

[0033] In some implementations, the elongated medical device includes a catheter.

[0034] In some implementations, sliding a mechanical dilator on the guidewire includes sliding a mechanical dilator on the guidewire in an open configuration.

[0035] In some implementations, sliding a mechanical dilator on the guidewire includes sliding a mechanical dilator on the guidewire in a closed configuration.

[0036] In some implementations, sliding the mechanical dilator on the guidewire includes changing the mechanical dilator from an open configuration to a closed configuration before insertion into the insertion site.

[0037] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of these concepts in more detail. Attached Figure Description

[0038] A more specific description of the disclosure will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Example embodiments of the invention will be described and illustrated with additional features and details using the drawings, wherein:

[0039] Figure 1A A side view of a mechanical expander according to some embodiments is shown.

[0040] Figure 1B A perspective view of a mechanical expander according to some embodiments is shown.

[0041] Figure 2A A perspective view of the expander body according to some implementation schemes is shown.

[0042] Figure 2B A plan view of the proximal end of an expander body including a channel, according to some embodiments, is shown.

[0043] Figure 3A A perspective view of a locking and stopping mechanism connected to a mechanical expander according to some embodiments is shown.

[0044] Figure 3B A cross-sectional view of a locking and stopping mechanism connected to a mechanical expander according to some embodiments is shown.

[0045] Figures 4A-4B A plan view of an exemplary method of an expansion mechanical expander according to some embodiments is shown.

[0046] Figures 5A-5C A perspective view is shown of an exemplary method of using a mechanical dilator in a medical device insertion system according to some embodiments.

[0047] Figure 6 A flowchart illustrating an exemplary method for using a mechanical expander to expand tissue around an insertion site, according to some implementation schemes, is shown. Detailed Implementation

[0048] It should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein, prior to the more detailed disclosure of certain specific embodiments. It should also be understood that the specific embodiments disclosed herein may have features that can be readily separated from the specific embodiments and optionally combined with or substituted for any of the various other embodiments disclosed herein.

[0049] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used for convenience and do not imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms of “a,” “an,” and “the” include plural references.

[0050] Regarding "proximal," for example, the "proximal portion" or "proximal portion" of a mechanical dilator disclosed herein includes the portion of the mechanical dilator intended to be close to the clinician when used on a patient. Similarly, for example, the "proximal length" of a mechanical dilator includes the length of the mechanical dilator intended to be close to the clinician when used on a patient. For example, the "proximal end" of a mechanical dilator includes the end of the mechanical dilator intended to be close to the clinician when used on a patient. The proximal portion, proximal portion, or proximal length of a mechanical dilator may include the proximal end of the mechanical dilator; however, the proximal portion, proximal portion, or proximal length of a mechanical dilator does not need to include the proximal end of the mechanical dilator. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a mechanical dilator is not the distal portion or distal length of the mechanical dilator.

[0051] Regarding "distal," for example, the "distal portion" or "distal part" of a mechanical dilator disclosed herein includes the portion of the mechanical dilator intended to be close to or located within the patient when used with the patient. Similarly, the "distal length" of a mechanical dilator includes the length of the mechanical dilator intended to be close to or located within the patient when used with the patient. For example, the "distal end" of a mechanical dilator includes the end portion of the mechanical dilator intended to be close to or located within the patient when used with the patient. The distal portion, distal part, or distal length of a mechanical dilator may include the distal end of the mechanical dilator; however, the distal portion, distal part, or distal length of a mechanical dilator need not include the distal end of the mechanical dilator. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a mechanical dilator is not the distal portion or distal length of the mechanical dilator.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0053] Figure 1A A side view of a mechanical expander 100 according to some embodiments is shown. In some embodiments, the mechanical expander 100 includes a first arm 104A and a second arm 104B. In some embodiments, an expander body 110 extends from the distal end of the first arm 104A and the distal end of the second arm 104B. In some embodiments, the expander body 110 extends to an expander tip 112. In some embodiments, the first arm 104A and the second arm 104B together define a locking and stop mechanism 120, which can be configured to restrict lateral movement of the first arm 104A relative to the second arm 104B. Figure 1AAs shown, 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.

[0054] Figure 1B A perspective view of a mechanical expander 100 according to some embodiments is shown. In some embodiments, the mechanical expander 100 can be configured to switch between a closed configuration and an open configuration. In some embodiments, a first arm 104A can be compressed toward a second arm 104B. In some embodiments, because 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 stop mechanism 120 can be located at the position 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 can include rectangular prisms, tapered rectangular prisms, rounded rectangular prisms, cuboids, cylinders, pentagonal prisms, hexagonal prisms, combinations thereof, etc. In some embodiments, the first arm 104A and the second arm 104B can be connected together by a pivot 116 extending therebetween. In some embodiments, the pivot 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 divided in two by a channel 118.

[0055] Figure 2A A perspective view of the expander body 110 according to some embodiments is shown. Figure 2A As shown, channel 118 divides expander body 110 into two equal sides, a first side 114A extending from first arm 104A and a second side 114B extending from second arm 104B. Expander body 110 can be configured to laterally expand or contract by lateral movement of the first arm 104A and the second arm 104B. In some embodiments, expander body 110 terminates at expander tip 112, and expander tip 112 may be tapered. In some embodiments, expander tip 112 may be sharp to facilitate entry of expander body 110 into the insertion site. In some embodiments, expander body 110 is cylindrical. However, other shapes are also contemplated. Advantageously, the cylindrical shape of expander body 110 allows isocircular expansion of tissue around the insertion site. In some embodiments, isocircular expansion reduces skin deflection and allows for consistent sizing of the insertion site, resulting in consistent placement of the medical device.

[0056] In one embodiment, the expander body 110 can be detachably connected to the first arm 104A and the second arm 104B. In one embodiment, the expander body 110 can be press-fitted, snap-fitted, or interference-fitted with the first arm 104A and the second arm 104B. In this embodiment, the mechanical expander 100 and the expander body 110 can be disposed separately, and then the expander body 110 can be connected to the first arm 104A and the second arm 104B before use. In some embodiments, various expander bodies 110 having different diameters 117 of channels 118 can be detachably connected to the mechanical expander 100. Detachable connection of various expander bodies 110 to the mechanical expander 100 allows the user to select the desired expansion at the insertion site before use. In some embodiments, the mechanical expander 100 including the expander body 110 can 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 a portion thereof including the expander body 110 may be configured to be reusable or disposable.

[0057] Figure 2B A plan view of a first arm 104A and a second arm 104B of a mechanical expander 100 according to some embodiments is shown. In some embodiments, a 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 uniform diameter 117 extending 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 therein. As the expander body 110 laterally expands, the diameter 117 of the channel 118 may also expand. As the expander body 110 laterally expands, the diameter 117 of the channel 118 may also expand uniformly. In some embodiments, the diameter 117 of the channel 118 may be expanded to be larger than the cross-sectional diameter of an elongated medical device, thereby allowing a portion of the elongated medical device to move through the channel 118.

[0058] Figure 3AA perspective view of a first locking plate 122A of a locking and stopping mechanism 120 according to some embodiments is shown. 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 configured to slidably engage a second locking plate 122B. In some embodiments, the first locking plate 122A includes a first tab 124A, a plurality of first ridges 126A projecting from the first locking plate 122A, a first recess 128A, and a first stop ridge 130A. In some embodiments, the first locking plate 122A may be configured to slidably engage a second tab 124B. In some embodiments, the mechanical expander 100 may include a first locking plate 122A coupled to the first arm 104A and a second tab 124B coupled to the second arm 104B.

[0059] Figure 3B A cross-sectional view of a first locking plate 122A and a second locking plate 122B, according to some embodiments, of a locking and stopping mechanism 120 coupled to a mechanical expander 100. In some embodiments, the second locking plate 122B includes a second tab 124B, a plurality of second ridges 126B projecting from the second locking plate 122B, a second recess 128B, and a second stop ridge 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 laterally compressed together, the first tab 124A slidably engages with the plurality of second ridges 126B, and the second tab 124B slidably engages with the plurality of first ridges 126A. The first arm 104A and the second arm 104B can be laterally compressed 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. A first stop ridge 130A prevents further lateral movement of the second tab 124B and the second arm 104B, while a second stop ridge 130B prevents further lateral movement of the first tab 124A and the first arm 104A. The first stop ridge 130A and the first recess 128A, as well as the second stop ridge 130B and the second recess 128B, ensure that the channel 118 can be configured to open to its maximum possible diameter. In some embodiments, a plurality of first ridges 126A can be configured to have the same number of ridges as a plurality of second ridges 126B. In some embodiments, each ridge within a plurality of first ridges 126A can be configured to have a corresponding ridge within a plurality of second ridges 126B.

[0060] In one embodiment, when the first tab 124A passes over each of the plurality of second ridges 126B and the second tab 124B passes over each of the plurality of first ridges 126A, the user can be notified by audible sounds (e.g., clicks, thumps, etc.) that the first tab 124A and the second tab 124B are traveling on the plurality of second ridges 126B. In this embodiment, the audible sounds of the first tab 124A and the second tab 124B passing over each of the plurality of second ridges 126B may correspond to an incremental increase in the expansion of the expander body 110. In some embodiments, the locking and stopping mechanism 120 may include visual indicators of the travel of the first tab 124A and the second tab on the plurality of second ridges 126B. In one embodiment, the visual indicator may include each of a plurality of first ridges 126A and a corresponding ridge of a plurality of second ridges 126B, the ridges having a different color corresponding to a specific diameter of the channel 118. In this embodiment, the user is able to visually determine the expansion progress of the expander body 110 and the diameter 117 of the channel 118. In some embodiments, audible sound and visual indicators of the progress of the first tab 124A through each of the plurality of second ridges 126B and the second tab 124B through each of the plurality of first ridges 126A may be combined to provide the user with two different mechanisms to determine the expansion progress of the expander body 110 and the diameter 117 of the channel 118.

[0061] In some embodiments, the locking and stopping mechanism 120 may 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 larger than the diameter of a user-selected elongated medical device. In some embodiments, the number of ridges in the plurality of first ridges 126A preceding the first recess 128A and the number of ridges in the plurality of second ridges 126B preceding the second recess 128B may be increased to be configured to increase the maximum diameter of the channel 118. In some embodiments, the user may desire that the diameter of the channel 118 be smaller than the maximum diameter of the channel 118. Before the second tab 124B is slidably engaged in the first recess 128A and the first tab is slidably engaged in the second recess 128B, the user may stop the advance of the first tab 124A and the second tab 124B at any position along the plurality of first and second ridges 126A / 126B.

[0062] In some embodiments, each of the plurality of first ridges 126A or the plurality of second ridges 126B may correspond to an increase in the diameter of the channel 118. In some embodiments, each of the plurality of first ridges 126A and the plurality of second ridges 126B may correspond to an increase in the diameter of the channel 118, which corresponds to the French catheter scale. For example, in a mechanical dilator 100 comprising five of the plurality of first ridges and a recess, extending a first tab 124A over the first of the plurality of second ridges 126B and extending a second tab 124B over the first of the plurality of second ridges can expand the channel diameter 117 to accommodate a 12 French catheter. Extending a first tab 124A over the second of the plurality of second ridges and extending a second tab 124B over the second of the plurality of second ridges can expand the channel diameter 117 to accommodate a 13 French catheter. Fixing the first tab 124A in the second recess of the second locking plate 122B and fixing the second tab 124B in the first recess of the first locking plate 122A can expand the channel diameter 117 to accommodate the 17 French catheter.

[0063] Figures 4A-4B A plan view of an exemplary method of expanding a mechanical expander 100 according to some embodiments is shown. The pivot 116 allows lateral movement of the first arm 104A relative to the second arm 104B to translate into an increase or decrease in the diameter 117 of the channel 118, and the first side 114A and the second side 114B to be moved laterally closer together or further apart. Figure 4A As shown, 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 together laterally. In some embodiments, the mechanical expander 100 can be configured in a closed configuration when the first side 114A and the second side 114B are in physical contact.

[0064] like Figure 4BAs shown, laterally compressing the first arm 104A and the second arm 104B 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 expander 100 can be configured to an open configuration when the first side 114A and the second side 114B are no longer in physical contact and are separated by a maximum permissible distance. In other words, the open configuration of the mechanical expander 100 includes the case where the first arm 104A and the second arm 104B are laterally compressed together and the channel diameter 117 is the maximum diameter allowed by the user and the locking and stop mechanism 120. In some embodiments, the mechanical expander 100 can slide into the insertion site in a closed configuration. In some embodiments, switching the mechanical expander 100 between a closed configuration and an open configuration expands the insertion site, including one or more surrounding tissues, as will be described in more detail herein. In some embodiments, the mechanical expander can be biased into 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, once the mechanical expander 100 has been changed from a closed configuration to an open configuration, the mechanical expander 100 may not change back to a closed configuration. In some embodiments, once the mechanical expander 100 has been changed from a closed configuration to an open configuration, the mechanical expander 100 may be changed back to a closed configuration by manually resetting the locking and stop mechanism 120.

[0065] Figures 5A-5C An exemplary method of using a mechanical dilator 100 in a medical device insertion system 200 according to some embodiments is shown. In some embodiments, the medical device insertion system 200 includes a guidewire 202 and a mechanical dilator 100. Figure 5A As shown, the guidewire 202 can be inserted into the target region 204 through the insertion portion 206. In some embodiments, once the guidewire 202 is inserted, the mechanical dilator 100, more specifically the dilator body 110, can be configured to slide on the guidewire 202 in a closed configuration to slidably engage the insertion portion 206, as shown. Figure 5B As shown. More specifically, guidewire 202 can be inserted through channel 118 and mechanical dilator 100 can slide on guidewire 202. In some embodiments, mechanical dilator 100 can slide on guidewire 202 in an open configuration and then transition to a closed configuration before insertion into insertion site 206. In some embodiments, such as Figure 5CAs shown, once the mechanical dilator 100 engages in the insertion portion 206, the mechanical dilator 100 can be configured to expand the insertion portion 206 by laterally compressing the first arm 104A relative to the second arm 104B and laterally expanding the first side 114A relative to the second side 114B, or simply, by transitioning from a closed configuration to an open configuration. In some embodiments, the locking and stop mechanism 120 can be configured to prevent excessive expansion of the tissue surrounding the insertion portion 206.

[0066] Figure 6 A flowchart illustrating an exemplary method 300 for placing an elongated medical device using a mechanical dilator 100 according to some embodiments is shown. In some embodiments, method 300 includes inserting a guidewire 202 into an insertion site 206 in a target region 204 (box 302). In some embodiments, the target region 204 may include an anatomical target (e.g., a blood vessel). In some embodiments, the guidewire 202 may be inserted into the insertion site 206 via an insertion needle. Method 300 further includes sliding the mechanical dilator 100 in a closed configuration over the guidewire 202 to slidably engage the insertion site 206 (box 304). In some embodiments, the dilator body 110 may slide into the insertion site 206 until a portion of the dilator body 110 is no longer visible. In some embodiments, the dilator body 110 may slide into the insertion site until the entire dilator body 110 is no longer visible. In some embodiments, the mechanical dilator 100 may slide on the guidewire 202 in an open configuration and transform into a closed configuration before insertion into the insertion site 206.

[0067] Method 300 further includes expanding the tissue surrounding the insertion site 206 using a mechanical dilator 100 (box 306). In some embodiments, expanding the tissue surrounding the insertion site 206 includes laterally compressing the first arm 104A relative to the second arm 104B to extend the first side 114A away from the second side 114B, thereby expanding the channel 118. Method 300 further includes configuring a locking and stop mechanism 120 to prevent over-expansion of the insertion site 206 (box 308). In some embodiments, configuring the locking and stop mechanism 120 includes laterally compressing the first arm 104A relative to the second arm 104B until the first tab 124A is secured in a second recess 128B of the second locking plate 122B and the second tab 124B is secured in a first recess 128A of the first locking plate 122A. In some embodiments, the locking and stop mechanism 120 is configured to laterally compress the first arm 104A relative to the second arm 104B until the first tab 124A is secured in one of a plurality of second ridges of the second locking plate, and the second tab 124B is secured in one of a plurality of first ridges of the first locking plate 122A.

[0068] Method 300 further includes removing the mechanical dilator 100 from the insertion site 206 (box 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 the optional step of sliding an elongated medical device over the guidewire 202, allowing it to slide through the channel 118 of the mechanical dilator 100 into the insertion site 206 (box 309). In some embodiments, the elongated medical device may include a catheter or a needle. Advantageously, inserting the mechanical dilator 100 through the guidewire 202 into the insertion site ensures that tissue expansion occurs along the path taken by the elongated medical device.

[0069] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, the intent of these specific embodiments is not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will likely occur to those skilled in the art, and are included in a broader sense as well. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A mechanical expander, characterized in that, include: A first arm, connected to a second arm via a pivot, and the first and second arms cooperatively defining a locking and stop mechanism comprising a plurality of separate locking positions, configured to restrict lateral movement of the first arm relative to the second arm, wherein the locking and stop mechanism includes a first locking plate configured to slidably engage a second locking plate; and An expander body having a first side extending perpendicularly from a first arm and a second side extending perpendicularly from a second arm, wherein the expander body includes a channel configured to divide the expander body into the first side and the second side. The support shaft is configured to convert the compressive lateral movement of the first arm relative to the second arm into an extended lateral movement of the first side relative to the second side. The mechanical expander is configured to switch between an open configuration and a closed configuration, wherein in the open configuration, the first side and the second side are not in physical contact.

2. The mechanical expander according to claim 1, characterized in that, 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, characterized in that, 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, characterized in that, The first arm is offset laterally from the second arm.

5. The mechanical expander according to claim 1, characterized in that, The channel has a uniform diameter and extends from the proximal end of each of the first and second arms to the top of the expander.

6. The mechanical expander according to claim 1, characterized in that, The first locking plate is connected to the first arm, and the second locking plate is connected to the second arm.

7. The mechanical expander according to claim 6, characterized in that, The first locking plate and the second locking plate each include a protrusion, a plurality of ridges, a recess, and a stop ridge.

8. The mechanical expander according to claim 1, characterized in that, In the closed structure, the first side and the second side are in physical contact.

9. The mechanical expander according to claim 1, characterized in that, In the opening 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 in the second recess of the second locking plate, and the second tab of the second locking plate is fixed in the first recess of the first locking plate.

10. The mechanical expander according to claim 1, characterized in that, The expander body is detachably connected to the first arm and the second arm.

11. The mechanical expander according to claim 10, characterized in that, The expander body is detachably connected by press fit, snap fit, or interference fit.

12. The mechanical expander according to claim 1, characterized in that, The mechanical expander may be disposable or reusable.

13. The mechanical expander according to any one of claims 5 to 12, characterized in that, The proximal ends of each of the first and second arms have chamfered edges.

14. The mechanical expander according to claim 5, characterized in that, The tip of the dilator is sharp to facilitate the insertion of the dilator body into the insertion site.

15. A medical device insertion system, characterized in that, include: Guide wire; and A mechanical expander configured to slide on the guide wire, the mechanical expander having a first arm connected to a second arm via a pivot, the first arm and the second arm cooperatively defining a locking and stop mechanism including a plurality of separate locking positions configured to restrict lateral movement of the first arm relative to the second arm, wherein the locking and stop mechanism includes a first locking plate configured to slidably engage a second locking plate; An expander body includes a first side extending perpendicularly from a first arm and a second side extending perpendicularly from a second arm, and a channel configured to slide on the guidewire, the channel dividing the expander body into the first side and the second side, wherein a pivot is configured to convert a compressive lateral movement of the first arm relative to the second arm into an expanding lateral movement of the first side relative to the second side. The mechanical expander is configured to switch between an open configuration and a closed configuration, wherein in the open configuration, the first side and the second side are not in physical contact.

16. The medical device insertion system according to claim 15, characterized in that, The first locking plate includes a first protrusion, a plurality of first ridges, a first recess, and a first stop ridge, and the second locking plate includes a second protrusion, a plurality of second ridges, a second recess, and a second stop ridge.

17. The medical device insertion system according to claim 15, characterized in that, In the closed structure, the first side and the second side are in physical contact.

18. The medical device insertion system according to claim 15, characterized in that, In the opening 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 in the second recess of the second locking plate, and the second tab of the second locking plate is fixed in the first recess of the first locking plate.

19. The medical device insertion system according to claim 17, characterized in that, In the closed configuration, the mechanical dilator slides on the guidewire.

20. The medical device insertion system according to any one of claims 15 to 19, characterized in that, The channel has a uniform diameter and extends from the proximal end of each of the first and second arms to the top of the expander.

21. The medical device insertion system according to claim 20, characterized in that, The tip of the dilator is sharp to facilitate the insertion of the dilator body into the insertion site.

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