Medical device for cutting sutures during minimally invasive procedures

Abstract

A medical device for severing sutures during a minimally invasive procedure includes an elongate shaft, a handle housing disposed at a proximal end of the elongate shaft, and a cutting blade disposed proximate a distal end of the elongate shaft. The proximal portion of the handle housing includes an actuation mechanism including a lever arm disposed outside the handle housing and having a first portion extending distally from the proximal portion of the handle housing. Movement of the first portion of the lever arm relative to the handle housing causes axial movement of the cutting blade within the elongate shaft. The medical device system may include a stand configured to support at least one medical device and a medical device securable to the stand.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods for using medical devices. More particularly, the present disclosure relates to aspects of medical devices for severing sutures during minimally invasive procedures such as chordae tendineae repair. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as surgical and / or intravascular applications. These medical devices are manufactured by any of a variety of different manufacturing methods and are used according to any of a variety of different methods. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and / or using medical devices. Summary of the Invention

[0003] In one example, a medical device for severing sutures during a minimally invasive procedure may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end, a handle housing disposed at the proximal end of the elongate shaft, and a cutting blade disposed proximate the distal end of the elongate shaft. The proximal portion of the handle housing may include an actuation mechanism including a lever arm disposed outside the handle housing and having a first portion extending distally from the proximal portion of the handle housing. Movement of the first portion of the lever arm relative to the handle housing may cause axial movement of the cutting blade within the elongate shaft.

[0004] Additionally or alternatively to any of the examples described herein, the actuation mechanism includes a rack that is axially slidable parallel to the central longitudinal axis and at least one gear engaged with the rack.

[0005] Additionally or alternatively to any of the examples described herein, the second portion of the lever arm, disposed inside the handle housing, is coupled to at least one gear. Additionally or alternatively to any example described herein, at least one gear has a semicircular profile.

[0006] Additionally or alternatively to any of the examples described herein, the cutting blade is operably coupled to the rack. Additionally or alternatively to any example described herein, movement of the first portion of the lever arm away from the handle housing causes axial movement of the rack within the handle housing.

[0007] Additionally or alternatively to any of the examples described herein, movement of the first portion of the lever arm away from the handle housing causes the rack to move axially proximally within the handle housing.

[0008] Additionally or alternatively to any example described herein, the medical device further comprises a locking element configured to prevent movement of the lever arm relative to the handle housing.

[0009] Additionally or alternatively to any of the examples described herein, a medical device system includes a stand configured to support at least one medical device and a medical device securable to the stand. The medical device may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end, a handle housing disposed at the proximal end of the elongate shaft, and a cutting blade disposed proximate the distal end of the elongate shaft. The proximal portion of the handle housing may include an actuation mechanism including a lever arm disposed outside the handle housing and having a first portion extending distally from the proximal portion of the handle housing. Movement of the first portion of the lever arm relative to the handle housing may cause axial movement of the cutting blade within the elongate shaft.

[0010] Additionally or alternatively to any example described herein, the stand includes a support member having a first yoke configured to engage the handle housing and a second yoke configured to engage the handle housing.

[0011] Additionally or alternatively to any examples described herein, the handle housing includes a first groove configured to engage the first yoke and a second groove configured to engage the second yoke.

[0012] Additionally or alternatively to any example described herein, the support member includes at least one locking element configured to secure the handle housing to the support member. Additionally or alternatively to any of the examples described herein, the stand includes a second support member configured to engage a steering system, the steering system having a steerable and flexible elongate tubular member extending away from the second support member, the steering system configured to receive the elongate shaft of the medical device within the steerable and flexible elongate tubular member.

[0013] Additionally or alternatively to any example described herein, the second support member includes a first yoke configured to engage a handle of the steering system and a second yoke configured to engage a handle of the steering system.

[0014] Additionally or alternatively to the examples described herein, a medical device for severing sutures during a minimally invasive procedure may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end, a handle housing disposed at the proximal end of the elongate shaft, and a cutting blade disposed proximate the distal end of the elongate shaft. The proximal portion of the handle housing may include an actuation mechanism configured to move the cutting blade within the elongate shaft. The actuation mechanism may include a rack disposed within the handle housing, the rack axially slidable parallel to the central longitudinal axis, and a lever arm having a first portion disposed outside the handle housing and a second portion disposed inside the handle housing, the second portion including a first leg fixedly attached to a first gear configured to engage the rack and a second leg fixedly attached to a second gear configured to engage the rack.

[0015] Additionally or alternatively to any example described herein, movement of the first portion of the lever arm relative to the handle housing causes axial movement of the rack within the handle housing.

[0016] Additionally or alternatively to any of the examples described herein, the pull wires extend from the rack to the cutting blade. Additionally or alternatively to any example described herein, the first leg and the second leg are disposed radially outward from the rack relative to the central longitudinal axis.

[0017] Additionally or alternatively to any of the examples described herein, the first leg and the second leg are disposed on opposite sides of the rack. Additionally or alternatively to any of the examples described herein, the distal portion of the handle housing includes one or more ports in fluid communication with the elongate shaft.

[0018] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0019] The present disclosure will be more fully understood from the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 illustrates selected embodiments of medical devices relevant to the present disclosure. [Figure 2] FIG. 2 illustrates selected embodiments of medical devices relevant to the present disclosure. [Figure 3] FIG. 3 illustrates selected embodiments of medical devices relevant to the present disclosure. [Figure 4] FIG. 4 is a partial cross-sectional view illustrating selected aspects of the medical device of FIGS. [Figure 4A] FIG. 4A is a perspective view detailing selected aspects of a cutting blade associated with a medical device. [Figure 5] FIG. 5 is a partial cutaway view illustrating selected embodiments of the medical device of FIGS. 1-3. [Figure 6] FIG. 6 is a partial cutaway view illustrating selected embodiments of the medical device of FIGS. 1-3. [Figure 7] FIG. 7 is a partial cutaway view illustrating selected embodiments of the medical device of FIGS. [Figure 8] FIG. 8 illustrates selected aspects related to the use of the medical device. [Figure 9] FIG. 9 illustrates selected aspects related to the use of the medical device. [Figure 10]FIG. 10 illustrates selected aspects related to the use of the medical device. [Figure 11] FIG. 11 illustrates selected aspects related to the use of the medical device. [Figure 12] FIG. 12 illustrates selected aspects of a medical device system relevant to the present disclosure. [Figure 13] FIG. 13 illustrates selected aspects of the medical device system of FIG. 12 in greater detail. [Figure 14] FIG. 14 illustrates selected aspects of an alternative configuration of a medical device system. DETAILED DESCRIPTION OF THE INVENTION

[0020] While aspects of the present disclosure are susceptible to various modifications and alternative forms, certain of which have been shown by way of example in the drawings and described in detail. It is to be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments illustrated. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0021] The following description should be read with reference to the drawings. The drawings are not necessarily to scale, and like reference numerals indicate like elements throughout the drawings. The detailed description and drawings are intended to illustrate, but not limit, the present disclosure. Those skilled in the art will recognize that the elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate example embodiments of the present disclosure.

[0022] For the following defined terms, these definitions shall be applied, unless a different definition is given either in the claims or this specification. All numerical values, whether expressly stated or not, are assumed to be modified by the term "about." The term "about," in the context of numerical values, generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" includes multiple numerical values ​​that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numeric contexts), unless expressly stated, are assumed to have the common and customary definition that can be understood from and consistent with the context of this specification.

[0023] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0024] Although certain preferred dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0025] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is used in the sense of "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that certain elements of the present disclosure may be described in the singular even if the element is present more than once or repeatedly in a disclosed embodiment. Each instance of an element may include and / or encompass a singular disclosure unless expressly stated otherwise. For purposes of brevity and clarity, not every element of the present disclosure is shown in each drawing or described in detail below. However, the following description may apply equally to any and / or all components present one or more times, unless expressly stated otherwise. In addition, not every instance of some element or feature may be shown in each drawing for purposes of clarity.

[0026] Relative terms such as "proximal," "distal," "advance," "retract," and variations thereof generally refer to the placement, orientation, and / or operation of various elements relative to a user / operator / operator of a device. Here, the terms "proximal" and "retract" mean or refer to being closer to or toward a device user, and the terms "distal" and "advance" mean or refer to being farther away from a user. In some instances, the terms "proximal" and "distal" have been assigned arbitrarily for purposes of facilitating understanding of the present disclosure, and such examples would be readily understood by one of ordinary skill in the art. Relative terms such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device. "Axial," "circumferential," "longitudinal," "lateral (also referred to as transverse)," "radial," and / or other relative terms generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structures or devices.

[0027] The term "extent" may be understood to mean the maximum measurement of a stated or identified dimension, unless the range or dimension in question is preceded by "minimum" or identified as such, and "minimum" may be understood to mean the minimum measurement of a stated or identified dimension. For example, the term "external extent" may be understood to mean the outer dimension, the term "radial extent" may mean the radial dimension, and the term "longitudinal extent" may be understood to mean the longitudinal extent. Examples of "extent" vary (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and are understandable to those skilled in the art from the context of their particular use. In general, "extent" may be considered the maximum possible dimension measured according to the intended use, while the term "minimum extent" may be considered the smallest possible dimension measured according to the intended use. In some examples, "extent" is measured orthogonally in a plane and / or a cross-section, but may also be measured diagonally, radially, circumferentially (e.g., along an arc), etc., as apparent from the specific context.

[0028] The terms "monolithic" and "integral" generally refer to an element or elements made from or consisting of a single structure or basic unit / element. Monolithic and / or integral element shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0029] References in the specification to "an embodiment," "some embodiments," "another embodiment," etc., mean that the described embodiment includes a particular element, structure, or characteristic, but not necessarily all embodiments include the particular element, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular element, structure, or characteristic is described in connection with a particular embodiment, it is within the knowledge of one skilled in the art to associate that particular element, structure, or characteristic with other embodiments, whether or not expressly stated, unless expressly stated otherwise. That is, even if not explicitly stated in a particular combination, those skilled in the art will understand that various elements described below can be combined or configured with each other to form additional embodiments or to complement or improve the described embodiments.

[0030] For purposes of clarity, certain numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or claims to name and distinguish features described in the specification and claimed herein. It should be understood that the numerical designations are for illustrative purposes only and are not intended to be limiting. In some embodiments, for purposes of brevity and clarity, variations or departures from previously used numerical designations may be made. That is, a feature identified as a "first" element may later be referred to as a "second" or "third" element, or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and designations in each instance will be understood by one of ordinary skill in the art.

[0031] Diseases and / or conditions affecting the cardiovascular system are prevalent worldwide. Some mammalian hearts (e.g., humans) have four types of heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. The purpose of the heart valves is to control blood flow from major veins (e.g., the inferior vena cava, the superior vena cava, etc.) into the heart, through the heart (from the atria to the ventricles), and out of the heart into major arteries connected to the heart (e.g., the aorta, the pulmonary artery, etc.). Each heart valve may have multiple leaflets configured to transition between an open configuration that allows fluid to flow through the heart valve and a closed configuration in which the free edges of the leaflets coapt to substantially prevent fluid from flowing through the heart valve. The heart may include a left atrium, a left ventricle, a right atrium, and a right ventricle. The left ventricle may include a first papillary muscle attached to and / or extending from the wall of the left ventricle, a second papillary muscle attached to and / or extending from the wall of the left ventricle, and multiple chordae tendineae connecting the first and second papillary muscles to the multiple leaflets of the mitral valve. In a normally functioning heart valve, blood is allowed to pass or flow downstream through the heart valve (e.g., from the atrium to the ventricle, from the ventricle to the artery, etc.) when the heart valve is open (e.g., during diastole), and blood is prevented from passing or flowing backward upstream through the heart valve (e.g., from the ventricle to the atrium, etc.) when the heart valve is closed (e.g., during systole).

[0032] In some instances, when mitral regurgitation occurs, the mitral valve may fail to open and / or close properly, allowing blood to pass through or backflow upstream through the mitral valve. In some instances, defective heart valves may cause the valve leaflets to fail to close or to close completely. In some instances, secondary or functional mitral regurgitation may be a secondary effect of left ventricular dysfunction, e.g., left ventricular dilation and / or expansion caused by ischemic or idiopathic cardiomyopathy, leading to left ventricular annular dilation and / or expansion, and subsequent leaflet tethering and papillary muscle displacement with insufficient coaptation of the mitral valve leaflets during systole. In some instances, degenerative mitral regurgitation may involve redundant tissue in parts of the heart valve and / or heart valve leaflets (e.g., mitral valve prolapse). In some instances, mitral regurgitation may be caused or exacerbated by stretching and / or rupture of one or more of the chordae tendineae.

[0033] Surgical methods for treating stretched or ruptured chordae tendineae may include replacing the chordae tendineae by suturing one or more sutures (e.g., Gore-Tex®, etc.) to the first and / or second papillary muscles and one or more of the valve leaflets to mimic natural chordae tendineae. However, open-heart surgery can pose significant risks to the patient, including complications, disability during recovery, and / or morbidity. Minimally invasive solutions may include transcatheter prosthetic valve replacement, but valve replacement may require lifelong anticoagulant therapy. Another alternative solution may involve marginal fixation of the valve leaflets, but such treatment precludes the option of future minimally invasive valve replacement surgery. Therefore, there is a need for a minimally invasive treatment for repairing heart valves while preserving options for future treatment options.

[0034] Disclosed herein are one or more medical devices, systems, and / or methods that can be used to diagnose, treat, and / or repair a portion of the cardiovascular system. One potential treatment is a percutaneous procedure that can replace stretched and / or ruptured chordae. The disclosed medical devices, systems, and / or methods can be used percutaneously, preferably via minimally invasive endovascular techniques, or alternatively, using open-heart surgery techniques. The medical devices, systems, and methods disclosed herein can also provide numerous additional desirable features and / or advantages, as described in more detail below.

[0035] FIG. 1 illustrates selected aspects of a medical device 200 for severing sutures 140 (e.g., FIGS. 3-4) during a minimally invasive procedure. In some embodiments, the medical device 200 may include an elongate shaft 210 having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end. In some embodiments, the medical device 200 and / or the elongate shaft 210 may include a distal tip member 220 fixedly attached to the distal end of the elongate shaft 210. In some embodiments, the distal tip member 220 may be integrally formed with the elongate shaft 210. In some embodiments, the distal tip member 220 may be constructed separately from the elongate shaft 210 and then fixedly attached to the elongate shaft 210. Some suitable, but non-limiting, materials for the elongate shaft 210 and / or distal tip member 220, such as metallic materials, polymeric materials, composite materials, etc., are described below.

[0036] In some embodiments, the cutting blade 260 can be disposed proximate the distal end of the elongate shaft 210. In some embodiments, the cutting blade 260 can be disposed within the distal tip member 220. Further details regarding the cutting blade 260 and / or the distal tip member 220 are described herein.

[0037] In some embodiments, medical device 200 may include a handle 300 and / or handle housing 310 disposed at the proximal end of elongate shaft 210. Elongate shaft 210 may extend distally from handle 300 and / or handle housing 310. In at least some embodiments, the proximal end of elongate shaft 210 may be fixedly attached to handle housing 310. In some embodiments, handle housing 310 may include an opening 306 extending through a sidewall of handle housing 310. Further details and / or uses of opening 306 are described below.

[0038] In some embodiments, the handle 300 and / or handle housing 310 may include one or more ports 330 attached to the handle housing 310 and in fluid communication with the elongate shaft 210. In some embodiments, the one or more ports 330 may include a first port 332 and a second port 334. In some embodiments, a fluid source may be connectable to the first port 332 via a first tube 333, and a vacuum source may be connectable to the second port 334 via a second tube 335, or vice versa. The fluid source may supply a fluid, such as saline or other biocompatible fluid, into the elongate shaft 210, and the vacuum source may aspirate and / or remove air bubbles, debris, contaminants, etc. from the elongate shaft 210. Other configurations are also contemplated. Some suitable, but non-limiting, materials for the handle 300, handle housing 310, etc., such as metallic materials, polymeric materials, composite materials, etc., are described below.

[0039] In some embodiments, the medical device 200 may be configured in a “side shooter” or single operator exchange (SOE) configuration. In a “side shooter” or single operator exchange (SOE) configuration, the suture 140 (e.g., of FIGS. 3 and 4 ) may enter a lumen of the medical device 200 at or near the distal end of the medical device 200, exit the side of the medical device 200, and then extend alongside the medical device 200. In some embodiments, the medical device 200 may be configured in an internal or over-the-wire (OTW) configuration. In an internal or over-the-wire (OTW) configuration, the suture 140 may enter a lumen of the medical device 200 at or near the distal end of the medical device 200 and extend internally the entire length of the medical device 200 to a proximal port or opening. Compared to the “side shooter” or single operator exchange (SOE) configuration, the built-in or over-the-wire (OTW) configuration may require the suture 140 to have additional length to allow the medical device 200 to be advanced over the entire length of the suture 140. In the “side shooter” or single operator exchange (SOE) configuration, the suture 140 may be shorter because the medical device 200 only requires a short portion of the suture 140 to be threaded through and / or inside the medical device 200. For purposes of illustration only, the medical device 200 is shown herein in a “side shooter” or single operator exchange (SOE) configuration, however, such illustration should not be construed as limiting the present disclosure to the “side shooter” or single operator exchange (SOE) configuration.

[0040] FIG. 2 shows selected aspects of the handle 300 and / or handle housing 310 in more detail. For clarity, some features and / or elements of the medical device 200 are not shown. In some embodiments, the distal portion 312 of the handle housing 310 may include one or more ports 330 (e.g., a first port 332, a second port 334, etc.) in fluid communication with the elongate shaft 210. In some embodiments, the proximal portion 314 of the handle housing 310 may include an actuation mechanism configured to move the cutting blade 260 relative to and / or within the elongate shaft 210. In some embodiments, the actuation mechanism may include a lever arm 340 having a first portion 342 disposed outside the handle housing 310 and extending distally from the proximal portion 314 of the handle housing 310. In some embodiments, the handle housing 310 may include a left handle housing 316 and a right handle housing 318. In at least some embodiments, a left handle housing 316 and a right handle housing 318 can be assembled to form the handle housing 310. In some embodiments, the left handle housing 316 and the right handle housing 318 can be assembled to form the handle housing 310 using removable fasteners (e.g., screws, bolts, etc.), snap fit features, mechanical latches, etc. Other configurations are also contemplated.

[0041] The handle housing 310 may include a longitudinally oriented opening that extends through a sidewall of the handle housing 310. The lever arm 340 may extend through and / or be movable within the longitudinally oriented opening of the handle housing 310. The lever arm 340 may be movable between an initial position and an actuated position.

[0042] In at least some embodiments, the first portion 342 of the lever arm 340 can be oriented parallel to the central longitudinal axis of the elongate shaft 210 in an initial position. In some embodiments, the medical device 200 can include a locking element configured to prevent movement of the lever arm 340 relative to the handle housing 310 and / or movement of the lever arm 340 within the longitudinally oriented opening. In some embodiments, the locking element can be configured to prevent unintended movement and / or actuation of the lever arm 340. In some embodiments, the locking element can be configured to prevent premature movement and / or actuation of the lever arm 340.

[0043] In at least some embodiments, the locking element may include a locking pin 304 configured to engage and prevent relative movement between the handle housing 310 and the lever arm 340. In some embodiments, the locking pin 304 may be disposed within and / or through an opening 306 in the handle housing 310 and may engage with the lever arm 340 inside the handle housing 310 when the lever arm 340 is disposed in an initial position, thereby preventing movement of the lever arm 340 relative to the handle housing 310 (e.g., toward the actuated position).

[0044] In some embodiments, the locking element may include a ratchet mechanism. In some embodiments, the locking element may include a cam mechanism. In some embodiments, the locking element may include a sliding mechanism and / or a slide lock. In some embodiments, the locking element may include an actuator. In some embodiments, the locking element may include a solenoid. In some embodiments, the locking element may include a knob or lever. In some embodiments, the locking element may include a frangible connection between the lever arm 340 and the handle housing 310. Other configurations are contemplated.

[0045] In some embodiments, the handle 300 may include a grip fixedly attached to the handle housing 310. In some embodiments, the handle housing 310 may include a grip monolithically and / or integrally formed therewith. The grip may be configured to be grasped by a user's hand. In some embodiments, the distal portion 312 of the handle housing 310 may include a grip, be formed as a grip, and / or include a grip monolithically and / or integrally formed therewith. Other configurations are also contemplated. In some embodiments, the handle housing 310 may be configured to engage with and / or be received by a stand 600 (e.g., FIGS. 12-13 ), as described herein.

[0046] In some embodiments, the handle housing 310 may include a first groove 350 configured to engage and / or be received by the stand 600, as described herein. In some embodiments, the first groove 350 may be disposed within the distal portion 312 of the handle housing 310 and / or proximate the distal end of the handle housing 310. Other configurations are also contemplated. In some embodiments, the first groove 350 may include a first circumferential surface 352 that extends circumferentially around the handle housing 310 and faces outwardly from the handle housing 310. The first circumferential surface 352 may be defined proximally by a first ridge 354 that extends circumferentially around the handle housing 310, and the first circumferential surface 352 may be defined distally by a second ridge 356 that extends circumferentially around the handle housing 310.

[0047] In some embodiments, the handle housing 310 may include a second groove 360 ​​configured to engage and / or be received by the stand 600, as described herein. In some embodiments, the second groove 360 ​​may be disposed within the proximal portion 314 of the handle housing 310 and / or proximate the proximal end of the handle housing 310. Other configurations are also contemplated. In some embodiments, the second groove 360 ​​may extend circumferentially around the handle housing 310 and include a second circumferential surface 362 facing outwardly from the handle housing 310. The second circumferential surface 362 may be defined proximally by a first ridge 364 extending circumferentially around the handle housing 310, and the second circumferential surface 362 may be defined distally by a second ridge 366 extending circumferentially around the handle housing 310.

[0048] Referring back to FIG. 3 , in some embodiments, the elongate shaft 210 and / or the distal tip member 220 may include a distal port 212 configured to receive the suture 140 therein. In some embodiments, the elongate shaft 210 and / or the distal tip member 220 may include a rounded distal cap 230 secured to the distal end of the elongate shaft 210 and / or the distal tip member 220. In some embodiments, the rounded distal cap 230 includes a distal port 232. In some embodiments, the distal port 212 and the distal port 232 may be the same port. In some embodiments, the distal port 212 and the distal port 232 may be in fluid communication with one another. Other configurations are also contemplated. Some suitable, but non-limiting, materials for the rounded distal cap 230, such as metallic materials, polymeric materials, ceramic materials, composite materials, etc., are described below.

[0049] The rounded distal cap 230 may be adapted, configured, and / or constructed to substantially avoid and / or prevent entanglement with multiple chordae that may be intact and / or unruptured when operating within the left ventricle of the heart. In at least some embodiments, the distal port 212 and / or the distal port 232 may be laterally and / or radially offset from the central longitudinal axis of the elongate shaft 210 to facilitate axial movement of the cutting blade 260, as described herein.

[0050] In some embodiments, the elongate shaft 210 and / or distal tip member 220 include a transverse slot 240 that extends radially inward from the outer surface of the elongate shaft 210 and / or the outer surface of the distal tip member 220, generally perpendicular to the central longitudinal axis of the elongate shaft 210. Further details regarding the transverse slot 240 are provided below.

[0051] 4 is a partial cross-sectional view illustrating selected elements associated with the structure of medical device 200, elongate shaft 210, and / or distal tip member 220, as well as selected aspects associated with severing suture 140. In particular, FIG. 4 illustrates elements disposed proximate the distal end of elongate shaft 210.

[0052] In some embodiments, the elongate shaft 210 and / or the distal tip member 220 may include a suture lumen 250 extending proximally within the elongate shaft 210 and / or the distal tip member 220. In some embodiments, the suture lumen 250 may extend axially and / or proximally within the elongate shaft 210, the distal tip member 220, and / or the rounded distal cap 230 from the distal port 212 and / or the distal port 232. In some embodiments, the suture lumen 250 may extend axially and / or proximally within the elongate shaft 210, the distal tip member 220, and / or the rounded distal cap 230 from the distal port 212 and / or the distal port 232 to the transverse slot 240.

[0053] In some embodiments, lateral slot 240 may include and / or may be at least partially formed by a distally-facing first proximal wall 242 that faces toward the distal end of elongate shaft 210 and / or distal tip member 220. lateral slot 240 may include and / or may be at least partially formed by a proximally-facing first distal wall 244 that faces toward the proximal end of elongate shaft 210 and / or distal tip member 220. In some embodiments, suture lumen 250 may open into lateral slot 240 through first distal wall 244.

[0054] In some embodiments, the medical device 200 may include a cutting blade 260 disposed proximate the distal end of the elongate shaft 210. A perspective view illustrating selected aspects of the cutting blade 260 in greater detail is provided in FIG. 4A for reference. In some embodiments, the cutting blade 260 may include a flat body portion 262 oriented substantially parallel to the central longitudinal axis of the elongate shaft 210. The flat body portion 262 of the cutting blade 260 may extend from the proximal end of the cutting blade 260 to the distal end of the cutting blade 260. In some embodiments, the cutting blade 260 may include a longitudinally oriented slot 264, which may extend transversely through the cutting blade 260 and / or extend transversely through the flat body portion 262 of the cutting blade 260. In some embodiments, the cutting blade 260 may include a sharp cutting edge 266 proximate the distal end of the cutting blade 260. In some embodiments, the sharp cutting edge 266 may face proximally, toward the proximal end of the elongate shaft 210 and / or distal tip member 220. In some embodiments, the sharp cutting edge 266 may face distally, toward the distal end of the elongate shaft 210 and / or distal tip member 220. In some embodiments, the cutting blade 260 may include a beveled portion 268 extending from the entire thickness of the flat body portion 262 toward the sharp cutting edge 266. The beveled portion 268 may be oriented at an oblique angle relative to the central longitudinal axis of the flat body portion 262 and / or elongate shaft 210.

[0055] In some embodiments, the cutting blade 260 may be slidably disposed within a longitudinally extending rectangular slot 270 formed within the elongate shaft 210 and / or the distal tip member 220. In some embodiments, the cutting blade 260 may be axially movable within the elongate shaft 210 and / or the distal tip member 220 in response to operation of an actuation mechanism. In some embodiments, the cutting blade 260 may be axially movable within the longitudinally extending rectangular slot 270 formed within the elongate shaft 210 and / or the distal tip member 220. In some embodiments, the cutting blade 260 may be axially movable between a first position and a second position in response to operation of an actuation mechanism.

[0056] In some embodiments, the cutting blade 260 can intersect the transverse slot 240 adjacent to the suture lumen 250. The suture 140 can be movable within the suture lumen 250 and / or movable relative to the elongate shaft 210 and / or distal tip member 220 when the cutting blade 260 is disposed in a first position and / or when the lever arm 340 is in an initial position. In some embodiments, the first position of the cutting blade 260 can be a distal position as seen in FIG. 4 and the second position of the cutting blade 260 can be a proximal position as seen in FIG. 10. In at least some embodiments, the cutting blade 260 can be non-rotatably disposed within the elongate shaft 210 and / or distal tip member 220. Some suitable, but non-limiting, materials for the cutting blade 260, such as metallic materials, polymeric materials, ceramic materials, composite materials, etc., are described below.

[0057] 4 , in some embodiments, the elongate shaft 210 and / or the distal tip member 220 can include a side port 280 located generally opposite the transverse slot 240 relative to the cutting blade 260. In some embodiments, the side port 280 can include and / or be at least partially formed by a distally-facing second proximal wall 282 that faces toward the distal end of the elongate shaft 210 and / or the distal tip member 220. In some embodiments, the second proximal wall 282 is axially offset from the first proximal wall 242 along the central longitudinal axis of the elongate shaft 210. In some embodiments, the second proximal wall 282 is distally offset from the first proximal wall 242. In some embodiments, the second proximal wall 282 is disposed distally of the first proximal wall 242. In some embodiments, the second proximal wall 282 is oriented generally parallel to the first proximal wall 242 .

[0058] In some embodiments, the second proximal wall 282 is spaced from the first proximal wall 242. In some embodiments, the cutting blade 260 is disposed between the first proximal wall 242 and the second proximal wall 282. In some embodiments, the second proximal wall 282 is spaced from the first proximal wall 242 by the cutting blade 260.

[0059] In some embodiments, medical device 200 and / or actuation mechanism may include a pull wire 302 extending proximally to the proximal end of medical device 200 and / or elongate shaft 210. In some embodiments, pull wire 302 may be fixedly attached to cutting blade 260. For example, pull wire 302 may be welded, brazed, soldered, adhesively bonded, or otherwise permanently and fixedly attached to cutting blade 260. In at least some embodiments, pull wire 302 may be formed from a metallic material. Other materials and / or configurations are also contemplated. Pull wire 302 may be substantially inelastic and / or adapted, configured, and / or constructed to substantially avoid and / or prevent axial stretching. Some suitable, but non-limiting, materials for pull wire 302, such as metallic materials, polymeric materials, ceramic materials, composite materials, etc., are described below.

[0060] 5-7 show selected elements of the medical device 200 and / or the handle 300. For improved understanding, the left handle housing 316 is not shown in FIG. 5 and the right handle housing 318 is not shown in FIGS. 6-7. Some elements described herein may be shown in more than one figure, and some elements described herein may be shown in one or more figures but not in one or more other figures.

[0061] In at least some embodiments, the actuation mechanism may include a rack 380 that is axially slidable within the handle housing 310. In some embodiments, the rack 380 may be axially slidable parallel to the central longitudinal axis of the elongate shaft 210. In some embodiments, the rack 380 may include a T-shaped cross-section. In some embodiments, the rack 380 may include a central body 381, a first flange 382, ​​and a second flange 383, as seen in FIGS. 5-6 . The first flange 382 and the second flange 383 may extend outward from the central body 381 laterally from the central longitudinal axis of the elongate shaft 210.

[0062] In some embodiments, the rack 380 may be slidably held between an upper slide 390 and a lower slide 392. The upper surface of the rack 380 may be oriented parallel to the upper slide 390 and / or the lower slide 392. The lower surface of the rack 380 may be oriented parallel to the upper slide 390 and / or the lower slide 392. In at least some embodiments, the upper slide 390 and / or the lower slide 392 may be oriented parallel to the central longitudinal axis. The upper slide 390 and / or the lower slide 392 may be laterally offset from the central longitudinal axis.

[0063] In some embodiments, the first flange 382 may include a first linear gear formed on and / or fixedly attached to the first flange 382, ​​and the second flange 383 may include a second linear gear formed on and / or fixedly attached to the second flange 383. In some embodiments, the first linear gear and the second linear gear may be oriented parallel to one another.

[0064] In some embodiments, the actuation mechanism may include at least one gear 384 engaged with the rack 380. In some embodiments, the at least one gear 384 may have a semicircular profile. In at least some embodiments, the at least one gear 384 may not be perfectly circular and / or may extend less than 360 degrees about the axis of rotation. In some embodiments, the at least one gear 384 may extend less than 270 degrees about the axis of rotation. In some embodiments, the at least one gear 384 may extend less than 225 degrees about the axis of rotation. In some embodiments, the at least one gear 384 may extend less than 180 degrees about the axis of rotation. In some embodiments, the at least one gear 384 may extend less than 135 degrees about the axis of rotation. In some embodiments, the at least one gear 384 may extend approximately 120 degrees, approximately 105 degrees, approximately 90 degrees, approximately 75 degrees, etc. about the axis of rotation.

[0065] In some embodiments, the at least one gear 384 may include a first gear 386 configured to engage the rack 380 and a second gear 388 configured to engage the rack 380, as seen in FIGS. 5-6 . In some embodiments, the at least one gear 384 may include only one gear (e.g., the first gear 386, the second gear 388, or a different gear). In some embodiments, the at least one gear 384 may include three or more gears. In some embodiments, the first gear 386 may be engaged with a first linear gear, and the second gear 388 may be engaged with a second linear gear.

[0066] In some embodiments, at least one gear 384 may be directly engaged with the rack 380. In some embodiments, the first gear 386 may be directly engaged with a first linear gear, and the second gear 388 may be directly engaged with a second linear gear. In some embodiments, at least one gear 384 may be directly engaged with the rack 380 such that a 1:1 gear ratio is used in the actuation mechanism. Although not explicitly shown, multiple gears can be used to form a gear set that engages the rack 380, changing the gear ratio to be greater or less than 1:1. Other configurations are also contemplated. In at least some embodiments, direct engagement between the at least one gear 384 and the rack 380 such that the gear ratio is 1:1 may be preferred.

[0067] In some embodiments, the second portion of the lever arm 340 can be disposed inside the handle housing 310. In some embodiments, the second portion of the lever arm 340 can include a first leg 346 and a second leg 348, as seen in FIGS. 5-6 . In at least some embodiments, the first leg 346 can be oriented parallel to the second leg 348. In some embodiments, the first leg 346 and the second leg 348 can be oriented transversely relative to the first portion 342 of the lever arm 340. In some embodiments, the first leg 346 and the second leg 348 can be oriented perpendicular to the first portion 342 of the lever arm 340. In some embodiments, the first leg 346 and the second leg 348 can be oriented transversely relative to the central longitudinal axis of the elongate shaft 210 in the initial position. In some embodiments, the first leg 346 and the second leg 348 may be positioned on opposite sides of a central longitudinal axis of the elongate shaft 210. In some embodiments, the first leg 346 and the second leg 348 may be positioned radially outward from the rack 380 relative to the central longitudinal axis of the elongate shaft 210. In some embodiments, the first leg 346 and the second leg 348 may be positioned on opposite sides of the rack 380.

[0068] In some embodiments, the second portion of the lever arm 340 may be coupled to at least one gear 384. In some embodiments, the first leg 346 and the second leg 348 may be coupled to at least one gear 384. In some embodiments, the first leg 346 may be coupled to the first gear 386 and the second leg 348 may be coupled to the second gear 388. In some embodiments, the first leg 346 may be fixedly attached to the first gear 386 and the second leg 348 may be fixedly attached to the second gear 388. In some embodiments, the first leg 346 may be monolithically and / or integrally formed with the first gear 386 and the second leg 348 may be monolithically and / or integrally formed with the second gear 388. Other configurations are contemplated.

[0069] In some embodiments, the lever arm 340 and / or the second portion of the lever arm 340 may be pivotally coupled to the handle housing 310. In some embodiments, the lever arm 340 may be configured to pivot and / or rotate about a pivot pin 349. In some embodiments, the pivot pin 349 may be configured to engage with one or more recesses formed in the handle housing 310 (e.g., the left handle housing 316, the right handle housing 318, etc.). In some embodiments, the pivot pin 349 may be monolithically and / or integrally formed with the second portion of the lever arm 340. In some embodiments, the pivot pin 349 may be monolithically and / or integrally formed with the handle housing 310, the left handle housing 316, and / or the right handle housing 318. In some embodiments, the pivot pin 349 may be a separate element from the lever arm 340, the handle housing 310, the left handle housing 316, and / or the right handle housing 318.

[0070] In some embodiments, the first leg 346 of the lever arm 340 may include an aperture 345 therein, as seen in FIG. 5 . The aperture 345 in the first leg 346 may be aligned with the aperture 306 in the handle housing 310 when the lever arm 340 is in the initial position. In some embodiments, the locking pin 304 (e.g., FIG. 2 ) may be configured to extend into and / or through the aperture 306 in the handle housing 310 and the aperture 345 in the first leg 346 when the lever arm 340 is in the initial position to prevent movement of the lever arm 340 relative to the handle housing 310 (e.g., toward the actuated position). Other locking elements as described herein are also contemplated.

[0071] In some embodiments, the handle housing 310 may include an internal chamber 320 in fluid communication with one or more ports 330 attached to the handle housing 310, as seen in FIGS. 5-7. The internal chamber 320 may include a chamber cover 322. In some embodiments, the chamber cover 322 may be removable from the internal chamber 320. In some embodiments, the internal chamber 320 may be in fluid communication with the elongate shaft 210 and one or more ports 330. In some embodiments, a fluid source may supply a fluid, such as saline solution or other biocompatible fluid, into the internal chamber 320 and / or the elongate shaft 210, and a vacuum source may aspirate and / or remove air bubbles, debris, contaminants, etc. from the internal chamber 320 and / or the elongate shaft 210. Other configurations are also contemplated. In at least some embodiments, the pull wire 302 may pass through the internal chamber 320 with the chamber cover 322 removed, as seen in FIG. 7. In some embodiments, the cutting blade 260 may be operably coupled to the rack 380. In some embodiments, the cutting blade 260 may be operably coupled to the rack 380 by a pull wire 302. In some embodiments, the pull wire 302 may extend distally from the rack 380 to the cutting blade 260. In some embodiments, the pull wire 302 may be fixed to the rack 380. In some embodiments, the pull wire 302 may be fixedly attached to the rack 380.

[0072] In some embodiments, movement of the first portion of the lever arm 340 relative to the handle housing 310 may cause the rack 380 to move axially within the handle housing 310, as seen in FIG. 8. In some embodiments, movement of the first portion of the lever arm 340 away from the handle housing 310 may cause the rack 380 to move axially within the handle housing 310. In some embodiments, movement of the first portion of the lever arm 340 away from the handle housing 310 may cause the rack 380 to move axially proximally within the handle housing 310. In some embodiments, movement of the first portion of the lever arm 340 relative to the handle housing 310 may cause the cutting blade 260 to move axially within the elongate shaft 210 and / or distal tip member 220, as seen in FIGS. 9-10.

[0073] In some embodiments, proximal axial movement of the cutting blade 260 relative to the elongate shaft 210 and / or distal tip member 220 (e.g., via proximal movement of the pull wire 302) and / or proximal axial movement of the cutting blade 260 within a longitudinally extending rectangular slot 270 formed within the elongate shaft 210 and / or distal tip member 220 can move the sharp cutting edge 266 of the cutting blade 260 toward the lateral slot 240 and / or the first proximal wall 242 that at least partially forms the lateral slot 240.

[0074] With regard to the operation of the medical device 200 and / or cutting blade 260, as shown in FIG. 4, when the cutting blade 260 is in the first position, the suture 140 extends within the suture lumen 250, into the lateral slot 240, through the longitudinally oriented slot 264 formed in the flat body portion 262 of the cutting blade 260, and out the side port 280, the suture 140 may be axially movable within the suture lumen 250, the longitudinally oriented slot 264, and the side port 280. As shown in FIG. 9 , when the suture 140 extends within the suture lumen 250, into the lateral slot 240, through the longitudinally oriented slot 264 formed in the flat body portion 262 of the cutting blade 260, and out the side port 280, and the cutting blade 260 is moved toward a second position (e.g., proximally) and / or relative to and / or within the elongate shaft 210 and / or distal tip member 220, the suture 140 may become sandwiched between the second proximal wall 282 and the angled portion 268 of the cutting blade 260, thereby causing the suture 140 to be pulled toward the cutting blade. 10 , further axial and / or proximal movement of the cutting edge 266 of the cutting blade 260 relative to and / or within the elongate shaft 210 and / or distal tip member 220 results in cooperation between the cutting edge 266 of the cutting blade 260 and the first proximal wall 242 to sever the suture 140 extending through the longitudinally oriented slot 264 of the cutting blade 260 within the elongate shaft 210 and / or distal tip member 220.

[0075] In some embodiments, the medical device 200 may include a stepped offset through the longitudinally oriented slot 264 of the flat body portion 262 of the cutting blade 260, and / or the first proximal wall 242 and the second proximal wall 282 may form a stepped offset. The angled portion 268 and the second proximal wall 282 may cooperate to bias the cutting blade 260 toward the first proximal wall 242, which uses the suture 140 itself to form and / or act as a shearing plane. As a result of this configuration, biasing springs and / or extremely tight tolerances are not required to achieve a clean cut of the suture 140. This may be particularly useful when the suture material undergoes at least some compression before the suture can or is cut. For example, some materials may have and / or include multiple voids within the material itself that can be compressed and / or squeezed before the cut is made. If excessive gap or lateral movement between the cutting blade and the shearing surface (e.g., the first proximal wall) is present in the device, the suture may be squeezed and / or pinched between the surfaces rather than being properly cut, which may lead to stretching, thinning without cutting, tearing, scraping or scraping of material, binding, excessive force required for axial movement of the cutting blade, etc.

[0076] For reference, FIG. 11 shows a perspective view of distal tip member 220 of medical device 200 of FIG. 10 after suture 140 has been cut and the proximal portion of suture 140 has been removed. 12-13 illustrate selected aspects of a medical device system 100. The medical device system 100 may include a stand 600 configured to support at least one medical device. In some embodiments, the medical device system 100 may include a medical device 200. The medical device 200 may be connectable and / or securable to the stand 600.

[0077] In some embodiments, stand 600 may include a base 610. In some embodiments, base 610 may be configured to be secured to a table. In some embodiments, base 610 may be configured to be secured to a surgical robot. Other configurations are also contemplated. In some embodiments, stand 600 may include a slide rail 620 coupled to stand 600. In some embodiments, slide rail 620 may be fixedly attached to base 610.

[0078] In some embodiments, the stand 600 may include a support member 630 slidably coupled to the slide rail 620. In some embodiments, at least one securing element 622 (e.g., a set screw, a thumb screw, a friction lock, etc.) may be configured to secure the support member 630 to and / or relative to the slide rail 620. In some embodiments, the support member 630 may include a first yoke 632 configured to engage with the handle housing 310 of the medical device 200 and a second yoke 634 configured to engage with the handle housing 310 of the medical device 200. In some embodiments, the first groove 350 and / or the first circumferential surface 352 may be configured to engage the first yoke 632, and the second groove 360 ​​and / or the second circumferential surface 362 may be configured to engage the second yoke 634. In some embodiments, the first yoke 632 may include a generally U-shaped portion and may be configured to receive the first groove 350 and / or the first perimeter surface 352 within the generally U-shaped portion. In some embodiments, the second yoke 634 may include a generally U-shaped portion and may be configured to receive the second groove 360 ​​and / or the second perimeter surface 362 within the generally U-shaped portion. In some embodiments, the support member 630 may include at least one fixation element 636 (e.g., a set screw, a thumb screw, a friction lock, etc.) configured to secure the medical device 200 and / or the handle housing 310 relative to the support member 630.

[0079] In some embodiments, stand 600 may include a second support member 640 slidably coupled to slide rail 620. In some embodiments, at least one securing element 622 (e.g., a set screw, thumb screw, friction lock, etc.) may be configured to secure second support member 640 to and / or relative to slide rail 620. In some embodiments, second support member 640 may include a first yoke 642 configured to engage a second medical device (e.g., steering system 700, described further below) and a second yoke 644 configured to engage the second medical device in a manner similar to first yoke 632 and second yoke 634 that engage medical device 200 and / or handle housing 310, described above. In some embodiments, first yoke 642 may include a generally U-shaped portion and may be configured to receive a second medical device within the generally U-shaped portion. In some embodiments, the second yoke 644 may include a generally U-shaped portion and may be configured to receive a second medical device within the generally U-shaped portion. In some embodiments, the second support member 640 may include at least one fixation element 646 (e.g., a set screw, a thumb screw, a friction lock, etc.) configured to secure the second medical device to and / or relative to the second support member 640.

[0080] In some embodiments, medical device system 100 may include a second medical device coupleable and / or securable to stand 600 and / or second support member 640. In some embodiments, the second medical device may include a steering system 700 for steerable and flexible elongate member 710. In some embodiments, steering system 700 may include a handle 720. Steerable and flexible elongate member 710 may extend distally from handle 720. In some embodiments, handle 720 may include a control knob 730 disposed on a housing block 740. Handle 720 and / or housing block 740 may be engageable and / or coupleable with second support member 640. In some embodiments, at least some working components of handle 720 and / or steering system 700 may be disposed within and / or supported by housing block 740. In one example, steering system 700 may include a gear system disposed within housing block 740 and operably coupled to and / or associated with control knob 730. Other configurations are contemplated.

[0081] In some embodiments, steering system 700 may include one or more flexible elongate steering elements 712 extending from housing block 740 along and / or into steerable flexible elongate member 710. In some embodiments, a gear system may be operatively engaged with and / or associated with one or more flexible elongate steering elements 712. In one example, the gear system may be configured to apply tension to the one or more flexible elongate steering elements 712 to selectively deflect, bend, and / or steer a distal portion and / or a distal tip of steerable flexible elongate member 710. In some embodiments, steering system 700 may be configured to deflect, bend, and / or steer a distal portion and / or a distal tip of steerable flexible elongate member 710 in at least one direction within a plane of deflection. In some embodiments, steering system 700 can be configured to deflect, bend, and / or steer a distal portion and / or distal tip of steerable flexible elongate member 710 in two opposing directions within a bending plane. Other configurations are also contemplated.

[0082] In some embodiments, the steerable and flexible elongate member 710 can extend away from the second support member 640. The steering system 700 can be configured to receive the elongate shaft 210 of the medical device 200 within the steerable and flexible elongate member 710, as seen in FIG. 12 . In at least some embodiments, the steering system 700 can be configured to slidably receive the elongate shaft 210 of the medical device 200 within the steerable and flexible elongate member 710. In some embodiments, the stand 600 can be used to axially secure the elongate shaft 210 relative to the steerable and flexible elongate member 710. Other configurations are contemplated.

[0083] In some embodiments, medical device system 100 may optionally include an adapter device 500. In some embodiments, adapter device 500 may be configured to receive elongate shaft 210 of medical device 200 at a proximal end and may extend into steering system 700 and / or steerable and flexible elongate member 710 at a distal end. In some embodiments, steerable and flexible elongate member 710 may have an inner diameter that is larger than the outer diameter of elongate shaft 210. In some embodiments, steerable and flexible elongate member 710 may be configured to receive more than one type and / or size of medical device. In some embodiments, the adapter device 500 can provide size adjustment between the elongate shaft 210 and the steerable and flexible elongate member 710 to prevent fluid leakage while allowing the steerable and flexible elongate member 710 to accept a medical device having an outer diameter larger than the outer diameter of the elongate shaft 210.

[0084] In some embodiments, support member 630 may be configured to receive and / or support one or more additional medical devices, which may be interchangeably received and / or engaged by first yoke 632 and / or second yoke 634 of support member 630.

[0085] 14 , the one or more additional medical devices may include a second steering system 800 for a steerable and flexible second elongate member 810. In some embodiments, the second steering system 800 may include a handle 820. The steerable and flexible second elongate member 810 may extend distally from the handle 820. In some embodiments, the handle 820 may include one or more control knobs 830 disposed on a housing block 840. The handle 820 and / or the housing block 840 may be engageable with and / or connectable to the support member 630. In some embodiments, at least some working components of the handle 820 and / or the second steering system 800 may be disposed within and / or supported by the housing block 840. In one example, second steering system 800 may be disposed within housing block 840 and operably coupled to one or more control knobs 830 and / or may include a gear system associated with one or more control knobs 830. Other configurations are contemplated.

[0086] In some embodiments, the second steering system 800 may include one or more flexible elongate steering elements extending from the housing block 840 along and / or within the steerable and flexible second elongate member 810. In some embodiments, a gear system may be operatively engaged with and / or associated with the one or more flexible elongate steering elements. In one example, the gear system may be configured to apply tension to the one or more flexible elongate steering elements to selectively deflect, bend, and / or steer a distal portion and / or a distal tip of the steerable and flexible second elongate member 810. In some embodiments, the second steering system 800 may be configured to deflect, bend, and / or steer a distal portion and / or a distal tip of the steerable and flexible second elongate member 810 in at least one direction within a plane of deflection. In some embodiments, the second steering system 800 may be configured to deflect, bend, and / or steer the distal portion and / or distal tip of the steerable and flexible second elongate member 810 in two opposite directions within a bending plane.

[0087] In some embodiments, the second steering system 800 may be configured to deflect, bend, and / or steer the distal portion and / or distal tip of the steerable and flexible second elongate member 810 in at least one direction within two different bending planes. Thus, in at least some embodiments, the second steering system 800 may be configured to provide four-way steering. In some embodiments, the second steering system 800 may be configured to deflect, bend, and / or steer the distal portion and / or distal tip of the steerable and flexible second elongate member 810 in two opposite directions in each of the two bending planes. In some embodiments, the two different bending planes may be oriented perpendicular to each other. Other configurations are also contemplated.

[0088] In some embodiments, the steerable and flexible second elongate member 810 may extend away from the support member 630 and / or may extend within the steerable and flexible elongate member 710 of the steering system 700. The second steering system 800 may be configured to receive the elongate shaft 910 of the third medical device 900 within the steerable and flexible second elongate member 810, as seen in FIG. 14 . In at least some embodiments, the second steering system 800 may be configured to slidably receive the elongate shaft 910 of the third medical device 900 within the steerable and flexible second elongate member 810. Other configurations are contemplated.

[0089] In some embodiments, the stand 600 may include an extension arm 650 extending proximally from the support member 630. In some embodiments, the extension arm 650 may be fixedly attached to the support member 630. In some embodiments, the extension arm 650 may include a third support member 652 slidably coupled to the extension arm 650. In some embodiments, at least one fixation element 654 (e.g., a set screw, thumb screw, friction lock, etc.) may be configured to secure the third support member 652 to and / or relative to the extension arm 650. In some embodiments, the third support member 652 may include a yoke 656 configured to engage the third medical device 900, as seen in FIG. 14 , in a manner similar to the first yoke 632 and second yoke 634 that engage the medical device 200 and / or handle housing 310 described above. In some embodiments, the yoke 656 may include a generally U-shaped portion configured to receive the third medical device 900 within the generally U-shaped portion. In some embodiments, the third support member 652 may include at least one fixation element 658 (e.g., a set screw, a thumb screw, a friction lock, etc.) configured to secure the third medical device 900 to and / or relative to the third support member 652.

[0090] In some embodiments, the third medical device 900 may include a delivery and deployment system configured to deliver, manipulate, and / or deploy the implantable device. In some embodiments, the third medical device 900 may include a handle 920 configured to engage the third support member 652 and / or the yoke 656 of the third support member 652.

[0091] The various components of the medical device and materials that can be used for those various elements disclosed herein can include those generally corresponding to medical instruments. For brevity, the following description will refer to systems. However, this is not intended to limit the devices and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, medical devices, medical device systems, elongate shafts, handle housings, cutting blades, pull wires, lever arms, and / or elements or components thereof.

[0092] In some embodiments, the system and / or its components may be formed of metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or another suitable material.

[0093] Other examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL®), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (e.g., HYTREL®), polyamides (e.g., DURETHAN®, or CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®). , polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID®, etc.), perfluor The material may include poly(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymer (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc.In some embodiments, the system and / or its components can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0094] Some examples of suitable metals and alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625, UNS: N06022, such as HASTELLOY® C-22®, HASTELLOY® C276®, etc.) and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® B2® UNS: N10665), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®); platinum strengthened stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0095] In at least some embodiments, some or all of the system and / or its components may be doped with, fabricated of, or contain a radiopaque material. A radiopaque material can be understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique (e.g., ultrasound) during a medical procedure. This relatively bright image assists the user of the system in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils can be incorporated into the system design to achieve similar results.

[0096] In some embodiments, the system and / or its components are provided with some degree of magnetic resonance imaging (MRI) compatibility. For example, the system and / or its components, or portions thereof, may be formed of a material that does not substantially distort images or produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The system, or portions thereof, may also be formed of a material that can be imaged by an MRI machine. Materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, etc.

[0097] In some embodiments, the system and / or other elements disclosed herein may include and / or be treatable with a suitable therapeutic agent. Examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, PPack (dextrophenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombotic agents, etc.). antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and antiplatelet peptides; vascular cell growth promoters (growth factor inhibitors, growth factor receptor antagonists, transcription activators, translation promoters, etc.); vascular cell growth inhibitors (growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); immunosuppressants ("olimus" drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0098] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and order of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the disclosure is, of course, defined in the language of the appended claims.

Claims

1. 1. A medical device for severing sutures during a minimally invasive procedure, comprising: an elongate shaft having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end; a handle housing disposed at the proximal end of the elongate shaft; a cutting blade disposed proximate the distal end of the elongate shaft; the proximal portion of the handle housing includes an actuation mechanism including a lever arm disposed exteriorly of the handle housing and having a first portion extending distally from the proximal portion of the handle housing; A medical device wherein movement of the first portion of the lever arm relative to the handle housing causes axial movement of the cutting blade within the elongate shaft.

2. The medical device of claim 1 , wherein the actuation mechanism includes a rack axially slidable parallel to the central longitudinal axis and at least one gear engaged with the rack.

3. The medical device of claim 2 , wherein a second portion of the lever arm disposed inside the handle housing is coupled to the at least one gear.

4. The medical device of claim 2 or 3, wherein the at least one gear has a semicircular profile.

5. The medical device of any one of claims 2 to 4, wherein the cutting blade is operably connected to the rack.

6. The medical device of any one of claims 2 to 5, wherein movement of the first portion of the lever arm away from the handle housing causes axial movement of the rack within the handle housing.

7. 7. The medical device of claim 6, wherein movement of the first portion of the lever arm away from the handle housing causes proximal axial movement of the rack within the handle housing.

8. The medical device of any one of claims 1 to 7, further comprising a locking element configured to prevent movement of the lever arm relative to the handle housing.

9. 1. A medical device system comprising: a stand configured to support at least one medical device; A medical device system comprising: a medical device according to any one of claims 1 to 8, which is fixable to the stand.

10. The stand is a support member having a first yoke configured to engage the handle housing and a second yoke configured to engage the handle housing; The handle housing includes: The medical device system of claim 9 , comprising a first groove configured to engage the first yoke and a second groove configured to engage the second yoke.

11. The medical device system of claim 10 , wherein the support member includes at least one locking element configured to secure the handle housing to the support member.

12. the stand includes a second support member configured to engage a steering system; the steering system includes a steerable, flexible, elongated tubular member extending away from the second support member; the steering system is configured to receive the elongate shaft of the medical device within the steerable, flexible, elongate tubular member; The second support member includes:

12. The medical device system of claim 9, comprising: a first yoke configured to engage a handle of the steering system; and a second yoke configured to engage the handle of the steering system.

13. 1. A medical device for severing sutures during a minimally invasive procedure, comprising: an elongate shaft having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end to the distal end; a handle housing disposed at the proximal end of the elongate shaft; a cutting blade disposed proximate the distal end of the elongate shaft; a proximal portion of the handle housing including an actuation mechanism configured to move the cutting blade within the elongate shaft; The actuation mechanism includes: a rack disposed within the handle housing, the rack being axially slidable parallel to the central longitudinal axis; a lever arm having a first portion disposed outside the handle housing and a second portion disposed inside the handle housing, the second portion including a first leg fixedly attached to a first gear configured to engage the rack, and a second leg fixedly attached to a second gear configured to engage the rack.

14. The medical device of claim 13 , wherein the first leg and the second leg are disposed radially outward from the rack relative to the central longitudinal axis.

15. The medical device of claim 13 or 14, wherein the first leg and the second leg are disposed on opposite sides of the rack.

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