Medical device for cutting sutures during minimally invasive procedures

Abstract

A medical device for cutting sutures during a minimally invasive procedure may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis, a handle disposed at the proximal end of the elongate shaft and including an actuation mechanism, and a cutting blade disposed proximate the distal end of the elongate shaft. The cutting blade is axially movable within the elongate shaft in response to operation of the actuation mechanism. The elongate shaft includes a distal port for receiving a suture. The elongate shaft includes a transverse slot extending inwardly from an outer surface of the elongate shaft generally perpendicular to the central longitudinal axis. The elongate shaft includes a suture lumen extending axially within the elongate shaft from the distal port to the transverse slot. The cutting blade intersects the transverse slot adjacent to the suture lumen.

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 disposed at the proximal end of the elongate shaft and including an actuation mechanism, and a cutting blade disposed proximate the distal end of the elongate shaft. The cutting blade is axially movable within the elongate shaft in response to actuation of the actuation mechanism. The elongate shaft includes a distal port configured to receive a suture therein. The elongate shaft includes a transverse slot extending inward from an outer surface of the elongate shaft generally perpendicular to the central longitudinal axis. The elongate shaft includes a suture lumen extending axially within the elongate shaft from the distal port to the transverse slot. The cutting blade intersects the transverse slot adjacent to the suture lumen.

[0004] Additionally or alternatively to the examples described herein, the elongate shaft includes a side port located generally opposite the transverse slot relative to the cutting blade. Additionally or alternatively to examples described herein, the transverse slot includes a first proximal wall facing toward the distal end of the elongate shaft, and the side port includes a second proximal wall facing toward the distal end of the elongate shaft, the second proximal wall being disposed distal to the first proximal wall.

[0005] Additionally or alternatively to the examples described herein, the cutting blade includes a flat body portion oriented substantially parallel to the central longitudinal axis. Additionally or alternatively to the examples described herein, the cutting blade includes a longitudinally oriented slot extending transversely through the cutting blade.

[0006] Additionally or alternatively to the examples described herein, the cutting blade further includes a sharp cutting edge adjacent the distal end of the cutting blade and facing toward the proximal end of the elongate shaft.

[0007] Additionally or alternatively to the examples described herein, proximal axial movement of the cutting blade relative to the elongate shaft moves the sharp cutting edge toward the lateral slot. Additionally or alternatively to the examples described herein, the sharp cutting edge is configured to cooperate with the transverse slot to sever a suture extending through the longitudinally oriented slot of the cutting blade.

[0008] Additionally or alternatively to the examples described herein, the elongate shaft includes a rounded distal cap secured to a distal end of the elongate shaft, the rounded distal cap including a distal port.

[0009] Additionally or alternatively to the examples described herein, in another example, a medical device for cutting 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 disposed at the proximal end of the elongate shaft and including an actuation mechanism, and a cutting blade disposed proximal to the distal end of the elongate shaft. The actuation mechanism includes a pivotal connection proximal to the distal end of the elongate shaft, the pivotal connection being coupled to the cutting blade. The cutting blade is axially movable within the elongate shaft in response to operation of the actuation mechanism. The elongate shaft includes a distal port configured to receive a suture therein. The elongate shaft includes a suture lumen extending proximally from the distal port within the elongate shaft. The cutting blade is configured to intersect the suture lumen upon axial movement of the cutting blade from a first position to a second position.

[0010] Additionally or alternatively to the examples described herein, the cutting blade is slidably disposed within a longitudinally extending rectangular slot. Additionally or alternatively to the examples described herein, the cutting blade includes a sharp cutting edge facing distally.

[0011] Additionally or alternatively to the examples described herein, the medical device may include a polymer block immovably disposed distally within a longitudinally extending rectangular slot in the cutting blade.

[0012] Additionally or alternatively to the examples described herein, the pivot connection includes a central pivot point and a slot extending radially from the central pivot point and configured to slidably engage a pin coupled to the cutting blade.

[0013] Additionally or alternatively to the examples described herein, the suture is movable within the suture lumen when the cutting blade is disposed in the first position. In addition to or alternative to the examples described herein, in another example, a medical device for cutting 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 distal tip member fixedly attached to the distal end of the elongate shaft, and a cutting blade non-rotatably disposed within the distal tip member. The cutting blade is axially movable within the distal tip member in response to operation of an actuation mechanism disposed near the proximal end of the elongate shaft. The distal tip member includes a distal port configured to receive a suture therein. The distal tip member includes a transverse slot extending radially inward from an outer surface of the distal tip member generally perpendicular to the central longitudinal axis, the transverse slot being at least partially formed by a distally-facing first proximal wall. The distal tip member includes a suture lumen extending axially within the distal tip member from the distal port to the transverse slot. The distal tip member includes a side port disposed generally opposite the transverse slot, the side port being at least partially defined by a distally-facing second proximal wall axially offset from the first proximal wall along the central longitudinal axis.

[0014] Additionally or alternatively to the examples described herein, the second proximal wall is offset distally from the first proximal wall. Additionally or alternatively to examples described herein, the second proximal wall is oriented generally parallel to the first proximal wall.

[0015] Additionally or alternatively to the examples described herein, the cutting blade is disposed between the first proximal wall and the second proximal wall. Additionally or alternatively to the examples described herein, when the suture extends within the suture lumen, into the lateral slot, through the longitudinally oriented slot in the cutting blade, and out the side port, and the cutting blade is moved proximally within the distal tip member, the suture biases the cutting blade toward the first proximal wall, away from the second proximal wall, such that further proximal movement of the cutting blade within the distal tip member results in cooperation between the sharp cutting edge of the cutting blade and the first proximal wall, causing the suture to be severed within the distal tip member.

[0016] 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]

[0017] 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] 1 is a partial cross-sectional view of an exemplary heart and mitral valve. [Figure 2] 1A-1D illustrate an exemplary process for implanting a chordae repair assembly. [Figure 3] 1A-1D illustrate an exemplary process for implanting a chordae repair assembly. [Figure 4] 1A-1D illustrate an exemplary process for implanting a chordae repair assembly. [Figure 5] 1A-1D illustrate an exemplary process for implanting a chordae repair assembly. [Figure 6] 1A-1D illustrate an exemplary process for implanting a chordae repair assembly. [Figure 7] FIG. 1 illustrates a configuration having two or more chordal repair assemblies implanted. [Figure 8] 1A-1D illustrate exemplary configurations of medical devices associated with the present disclosure. [Figure 9]1A-1D illustrate exemplary configurations of medical devices associated with the present disclosure. [Figure 10] 1A-1D illustrate selected aspects of the structure and use of medical devices associated with the present disclosure. [Figure 11] 1A-1D illustrate selected aspects of the structure and use of medical devices associated with the present disclosure. [Figure 12] 1A-1D illustrate selected aspects of the structure and use of medical devices associated with the present disclosure. [Figure 13] 10A-10C illustrate side views of alternative configurations of medical devices associated with the present disclosure. [Figure 14] 1A-1D illustrate selected aspects of the structure and use of medical devices associated with the present disclosure. [Figure 15] 1A-1D illustrate selected aspects of the structure and use of medical devices associated with the present disclosure. [Figure 16] 10A-10C illustrate selected aspects of the construction and use of alternative configurations of medical devices associated with the present disclosure. [Figure 17] 10A-10C illustrate selected aspects of the construction and use of alternative configurations of medical devices associated with the present disclosure. [Figure 18] 1A-1D illustrate selected aspects of a handle associated with a medical device. [Figure 19] 10A-10C illustrate selected aspects of alternative configurations of a handle associated with a medical device. [Figure 20] FIG. 20 is a partial cross-sectional view of the handle of FIG. 19. DETAILED DESCRIPTION OF THE INVENTION

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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).

[0022] Although some preferred dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, it will be understood by those skilled in the art after reading this specification that the desired dimensions, ranges, and / or values ​​can be derived from the explicit descriptions.

[0023] 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.

[0024] 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 further away from or 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," "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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] Diseases and / or conditions affecting the cardiovascular system are prevalent worldwide. Some mammalian hearts (e.g., humans) include four types of heart valves: a tricuspid valve 12, a pulmonary valve 14, an aortic valve 16, and a mitral valve 18, as seen in the exemplary heart 10 shown in partial cross-section in FIG. 1 . The purpose of the heart valves is to control blood flow from major veins (e.g., inferior vena cava 24, superior vena cava 26, etc.) into the heart 10, through the heart 10 (from the atria to the ventricles), and out of the heart 10 into major arteries connected to the heart 10 (e.g., the aorta 20, the pulmonary artery 22, 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 10 may also include a left atrium 30, a left ventricle 40, a right atrium 50, and a right ventricle 60. The left ventricle 40 may include a first papillary muscle 42 attached to and / or extending from the wall of the left ventricle 40, a second papillary muscle 44 attached to and / or extending from the wall of the left ventricle 40, and a plurality of chordae tendineae 46 connecting the first papillary muscle 42 and the second papillary muscle 44 to the plurality of leaflets of the mitral valve 18. 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 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).

[0030] In some instances, when mitral regurgitation occurs, a heart valve (e.g., mitral valve 18) may be unable to properly open and / or close, causing blood to pass through or flow backward upstream through the heart valve (e.g., from the ventricle to the atrium, etc.). In some instances, a defective heart valve 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 dilation caused by ischemic or idiopathic cardiomyopathy, leading to, for example, annular dilation and / or expansion of the left ventricle 40 and subsequent leaflet tethering and displacement of the papillary muscles 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 can be caused or exacerbated by stretching and / or rupture of one or more of the chordae tendineae 46.

[0031] 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 42 and 44 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.

[0032] Disclosed herein are one or more medical devices and / or one or more 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 and / or methods can be used percutaneously, preferably via minimally invasive endovascular techniques, or alternatively, using open-heart surgery techniques. The medical devices and methods disclosed herein can also provide numerous additional desirable features and / or advantages, as described in more detail below. For purposes of this disclosure, the following description relates to repairing multiple chordae 46 attached to the mitral valve 18 and is so described for brevity. However, this is not intended to be limiting, and one of ordinary skill in the art will recognize that the following description can be applied to other heart valves with no or only minimal changes to the structure and / or scope of the present disclosure. Additionally, while the present disclosure is described in the context of repairing one of the multiple chordae 46 for the sake of brevity, it may be applied within the scope of the present disclosure to repairing two or more of the multiple chordae 46.

[0033] 2-7 illustrate aspects of a percutaneous and / or minimally invasive method for implanting artificial chordae in the left ventricle 40. Some aspects of the method may be performed according to techniques known in the art and therefore will not be described in detail. As seen in FIG. 2 , the method may include accessing the left atrium 30 and / or the mitral valve 18 using a delivery catheter 100. In some embodiments, the delivery catheter 100 may access the left atrium 30 and / or the mitral valve 18 transseptally. In some embodiments, the delivery catheter 100 may access the mitral valve 18 via a transaortic approach. Other techniques and / or configurations are also contemplated. Some suitable, but non-limiting, materials for the delivery catheter 100, such as metallic materials, polymeric materials, composite materials, etc., are described below.

[0034] Chordal repair assembly 110 may then be implanted from delivery catheter 100 into heart 10. In at least some embodiments, chordal repair assembly 110 may be implanted into left ventricle 40 of heart 10. In some embodiments, chordal repair assembly 110 may include leaflet grasping elements 120, ventricular anchors 130, and sutures 140 connecting leaflet grasping elements 120 to ventricular anchor 130. In some embodiments, additional elements may be included in chordal repair assembly 110.

[0035] The leaflet grasping element 120 may be attached to one of the leaflets of the mitral valve 18 using known delivery devices and / or techniques, such as a first catheter advanced through the delivery catheter 100. In some embodiments, the leaflet grasping element 120 may be attached to one of the leaflets of the mitral valve 18 from within the left ventricle 40. In some embodiments, the leaflet grasping element 120 may be attached to a free edge of one of the leaflets of the mitral valve 18. In at least some embodiments, the leaflet grasping element 120 may be fixedly attached to the free edge of one of the leaflets of the mitral valve 18. In some embodiments, the leaflet grasping element 120 may be removably attached to the free edge of one of the leaflets of the mitral valve 18.

[0036] In some embodiments, leaflet grasping element 120 may include a spring clip configured to clamp the free edge of one of the leaflets of mitral valve 18. In some embodiments, leaflet grasping element 120 may include a ratcheting clip mechanism, a threaded fixation element, or another type of element configured to attach to the free edge of one of the leaflets of mitral valve 18. Other configurations are also contemplated. Some suitable, but non-limiting, materials for leaflet grasping element 120 and / or other associated components are described below, such as metallic materials, polymeric materials, composite materials, etc.

[0037] In some embodiments, medical imaging may be used to facilitate placement of leaflet grasping element 120 and to verify the placement of leaflet grasping element 120. In some embodiments, medical imaging may be used to verify the quality of attachment of leaflet grasping element 120 to one of the leaflets of mitral valve 18. If the placement and / or quality of attachment of leaflet grasping element 120 is unsatisfactory, leaflet grasping element 120 may be removed and repositioned or replaced with a different leaflet grasping element.

[0038] The ventricular anchor 130 may be attached to tissue within the left ventricle 40 using known delivery devices and / or delivery techniques, such as a second catheter advanced into the heart 10 through the delivery catheter 100. In some embodiments, the ventricular anchor 130 may be attached to the first papillary muscle 42, as shown in FIG. 2 . In some embodiments, the ventricular anchor 130 may be attached to the second papillary muscle 44. In some embodiments, the ventricular anchor 130 may be attached to the wall of the left ventricle 40. As explained above, some procedures may use more than one chordae tendineae repair assembly 110, and in such procedures, one or more ventricular anchors may be attached to at least one, and in some cases, more than one, of the first papillary muscle 42, the second papillary muscle 44, and / or the wall of the left ventricle 40. In some embodiments, the ventricular anchor 130 may be fixedly attached to tissue within the left ventricle 40. In some embodiments, the ventricular anchor 130 may be fixedly attached to the first papillary muscle 42. In some embodiments, the ventricular anchor 130 may be fixedly attached to the second papillary muscle 44. In some embodiments, the ventricular anchor 130 may be fixedly attached to the wall of the left ventricle 40. In some embodiments, the ventricular anchor 130 may be removably attached to tissue within the left ventricle 40. In some embodiments, the ventricular anchor 130 may be removably attached to the first papillary muscle 42. In some embodiments, the ventricular anchor 130 may be removably attached to the second papillary muscle 44. In some embodiments, the ventricular anchor 130 may be removably attached to the wall of the left ventricle 40. Other configurations are also contemplated. Some suitable, but non-limiting, materials for the ventricular anchor 130 and / or other related components are described below, e.g., metallic materials, polymeric materials, composite materials, etc.

[0039] In some embodiments, medical imaging may be used to facilitate placement of ventricular anchor 130 and to verify the placement location of ventricular anchor 130. In some embodiments, medical imaging may be used to verify the quality of attachment of ventricular anchor 130 to tissue within left ventricle 40. If the placement location and / or quality of attachment of ventricular anchor 130 is unsatisfactory, ventricular anchor 130 may be removed and repositioned or replaced with a different ventricular anchor.

[0040] As seen in FIG. 2 , after placement of the leaflet grasping elements 120 and the ventricular anchor 130, the suture 140 may extend from the leaflet grasping elements 120, through the ventricular anchor 130, and into the delivery catheter 100. In some embodiments, the suture 140 may be a surgical suture as known in the art. In some embodiments, the suture 140 may be and / or include a filament, strand, wire, thread, or other flexible member. In some embodiments, the suture 140 may be substantially inelastic in the axial direction (e.g., longitudinally). Thus, the suture 140 may be adapted, configured, and / or constructed to substantially avoid or prevent axial stretching. In some embodiments, the suture 140 may be configured to allow limited axial stretching (e.g., less than 10%, less than 5%, less than 2%, etc.). Some suitable, but non-limiting, materials for the suture 140 are described below, such as metallic materials, polymeric materials, composite materials, etc.

[0041] 3 , the tension on the suture 140 between the leaflet grasping element 120 and the ventricular anchor 130 can be adjusted as needed to provide sufficient and / or appropriate movement of the leaflets of the mitral valve 18. For example, at least a portion of the suture 140 can be pulled proximally to remove slack therefrom. In some embodiments, at least a portion of the suture 140 can be pulled proximally to decrease the distance between the leaflet grasping element 120 and the ventricular anchor 130 and / or adjust the tension therebetween.

[0042] In some embodiments, the ventricular anchor 130 may be selectively lockable to and / or relative to the suture 140. Thus, the suture 140 may be configured to slide through the ventricular anchor 130 when the ventricular anchor 130 is in the unlocked configuration, and the suture 140 may be secured relative to the ventricular anchor 130 when the ventricular anchor 130 is in the locked configuration.

[0043] After tension is applied to the suture 140, the ventricular anchor 130 may be shifted from the unlocked configuration to the locked configuration. With the ventricular anchor 130 in the locked configuration, the effect of the chordae tendineae repair assembly 110 on the valve leaflets and valve function may be observed using medical imaging. Further tensioning and / or loosening of the suture 140 may be performed (via unlocking and relocking the ventricular anchor 130 as needed) until the desired function is achieved and / or obtained.

[0044] As seen schematically in Figure 4, a medical device 200 for cutting the suture 140 may then be advanced over the suture 140 and / or through the delivery catheter 100. Further details related to the medical device 200 are described below. As shown in Figure 5, the medical device 200 may be positioned adjacent the proximal end of the ventricular anchor 130, and the suture 140 may be cut using the medical device 200, as described herein.

[0045] FIG. 6 illustrates a chordae tendineae repair assembly 110 in place within the heart 10. In some embodiments, the method and / or technique may require only one chordae tendineae repair assembly 110. In some embodiments, the method and / or technique may require a first chordae tendineae repair assembly 110 having a first ventricular anchor 130 attached to a first papillary muscle 42 and a second chordae tendineae repair assembly 110 having a second ventricular anchor 130 attached to a second papillary muscle 44, as shown in FIG. 7. In some embodiments, the first chordae tendineae repair assembly 110 and / or the first leaflet grasping element 120 may be spaced apart from the second chordae tendineae repair assembly 110 and / or the second leaflet grasping element 120. Other configurations are also contemplated. In at least some embodiments, placement of multiple chordae tendineae repair assemblies may be performed through the same delivery catheter to minimize access points to the patient's vasculature and / or heart.

[0046] 5 and 6, the medical device 200 is shown in a "side shooter" or single operator exchange (SOE) configuration. In the "side shooter" or single operator exchange (SOE) configuration, the suture 140 may enter the 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 through the delivery catheter 100. FIG. 8 shows selected embodiments of the medical device 200 in a "side shooter" or single operator exchange (SOE) configuration. In some configurations, the medical device 200 may have an internal or over-the-wire (OTW) configuration, some embodiments of which are shown in FIG. 9. In the internal or over-the-wire (OTW) configuration, the suture 140 may enter the 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 internal or over-the-wire (OTW) configuration may require the suture 140 to have additional length to allow for the medical device 200 to be advanced 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.

[0047] As seen in FIGS. 8-9 , 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, medical device 200 may include a handle 300 (e.g., FIGS. 19-20 ) disposed at the proximal end of elongate shaft 210. In some embodiments, medical device 200 and / or handle 300 may include an actuation mechanism, as described herein. In some embodiments, at least a portion of the actuation mechanism may be disposed proximate the proximal end of elongate shaft 210.

[0048] In some embodiments, medical device 200 and / or elongate shaft 210 may include a distal tip member 220 fixedly attached to the distal end of elongate shaft 210. In some embodiments, distal tip member 220 may be integrally formed with elongate shaft 210. In some embodiments, distal tip member 220 may be constructed separately from elongate shaft 210 and then fixedly attached to elongate shaft 210. Some suitable, but non-limiting, materials for elongate shaft 210 and / or distal tip member 220, such as metallic materials, polymeric materials, composite materials, etc., are described below.

[0049] 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.

[0050] The rounded distal cap 230 may be adapted, configured, and / or constructed to substantially avoid and / or prevent entanglement with multiple chordae 46, which may be intact and / or unruptured, when operating within the left ventricle 40 of the heart 10 (e.g., FIG. 1 ). 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.

[0051] 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 a central longitudinal axis of the elongate shaft 210. Further details regarding the transverse slot 240 are provided below.

[0052] 10-12 are partial cross-sectional views illustrating selected aspects of the configuration of medical device 200 and selected aspects of the cutting of suture 140. In some embodiments, elongate shaft 210 and / or distal tip member 220 can include a suture lumen 250 extending proximally within elongate shaft 210 and / or distal tip member 220. In some embodiments, suture lumen 250 can extend axially and / or proximally within elongate shaft 210, distal tip member 220, and / or rounded distal cap 230 from distal port 212 and / or distal port 232. In some embodiments, the suture lumen 250 may extend from the distal port 212 and / or the distal port 232 axially and / or proximally within the elongate shaft 210, the distal tip member 220, and / or the rounded distal cap 230 to the lateral 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. 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 includes 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 blade 260 may include a sharp cutting edge 266 proximate the distal end of the 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. In at least some embodiments, the cutting blade 260 may be non-rotatably disposed within the elongate shaft 210 and / or the 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.

[0056] In some embodiments, the elongate shaft 210 and / or distal tip member 220 can include a side port 280 located generally opposite the transverse slot 240 from 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 facing toward the distal end of the elongate shaft 210 and / or 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 located 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 .

[0057] 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.

[0058] 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.

[0059] 10-12, in some embodiments, the cutting blade 260 can intersect the transverse slot 240 adjacent 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. In some embodiments, the first position of the cutting blade 260 can be a distal position as seen in FIG. 10, and the second position of the cutting blade 260 can be a proximal position as seen in FIG. 12.

[0060] As shown in Figures 10-12, 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 defines the lateral slot 240.

[0061] As shown in FIG. 10 , 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 in the first position, 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. 11 , 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 away from the cutting blade. The cutting edge 266 of the cutting blade 260 can be biased toward the first proximal wall 242, away from the second proximal wall 282, such that, as the cutting edge 266 of the cutting blade 260 is moved further axially and / or proximally relative to and / or within the elongate shaft 210 and / or distal tip member 220, as shown in FIG. 12 , cooperation between the cutting edge 266 of the cutting blade 260 and the first proximal wall 242 occurs 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.

[0062] The design of the medical device 200 shown in FIGS. 10-12 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 surface. 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 if 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.

[0063] In some alternative embodiments, the medical device 200 may include a different configuration for the distal tip member 220 fixedly attached to the distal end of the elongate shaft 210, as seen, for example, in FIGS. 13-17 . While not explicitly shown, it should be understood that at least some embodiments of the medical device 200 shown in FIGS. 13-17 may include a rounded distal cap 230, as described herein. In some embodiments, the distal tip member 220 may include a first side portion 221 and a second side portion 222. As above, the elongate shaft 210 and / or the distal tip member 220 may include a distal port 212. While the medical device 200 is explicitly shown in FIGS. 13-17 as having an internal or over-the-wire (OTW) configuration, the medical device 200 may have a “side shooter” or single operator exchange (SOE) configuration, as described herein.

[0064] 14-17 illustrate selected aspects related to the configuration of medical device 200 and selected aspects related to the severing of suture 140. In FIGS. 14-17, first side 221 of distal tip member 220 is not shown for clarity.

[0065] In some embodiments, the elongate shaft 210 and / or distal tip member 220 may include a suture lumen 250 extending proximally within the elongate shaft 210 and / or distal tip member 220. In some embodiments, the suture lumen 250 may extend axially and / or proximally within the elongate shaft 210, distal tip member 220, and / or rounded distal cap 230 from the distal port 212 and / or distal port 232 (rounded distal cap 230 not shown).

[0066] In some embodiments, the medical device 200 may include a cutting blade 260 disposed proximate the distal end of the elongate shaft 210. 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 blade 260 may include a sharp cutting edge 266 proximate the distal end of the blade 260. In some embodiments, the sharp cutting edge 266 may face proximally, toward the proximal end of the elongate shaft 210 and / or the 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 the distal tip member 220. In some embodiments, the cutting blade 260 may include an angled portion 268 extending from the entire thickness of the flat body portion 262 to a sharp cutting edge 266. The angled portion 268 may be oriented at an oblique angle relative to the central longitudinal axis of the flat body portion 262 and / or the elongate shaft 210.

[0067] 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. In at least some embodiments, the cutting blade 260 may be non-rotatably disposed within the elongate shaft 210 and / or the 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.

[0068] In some embodiments, the actuation mechanism may include a pivot connection 290 proximate the distal end of the elongate shaft 210 and / or within the distal tip member 220. The pivot connection 290 may be movably coupled to the cutting blade 260. In some embodiments, the pivot connection 290 may be configured to move and / or actuate within the distal tip member 220 and / or the distal end of the elongate shaft 210 to axially move the cutting blade 260 within and / or relative to the elongate shaft 210 and / or distal tip member 220.

[0069] In some embodiments, the pivot connection 290 may include at least one bar 291 configured to rotate about a central pivot point 292. In some embodiments, the central pivot point 292 may include and / or be a pin, shaft, dowel, or the like. In some embodiments, the pivot connection 290 and / or the at least one bar 291 may include a slot 293 extending radially from the central pivot point 292 and configured to slidably and / or pivotally engage a pin 294 coupled to the cutting blade 260 proximate and / or adjacent to a first end of the at least one bar 291. In some embodiments, the pivot connection 290 may include a second bar member 295 pivotally coupled to a second end of the at least one bar 291 opposite the first end of the at least one bar 291.

[0070] 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 coupled to pivot connection 290. In some embodiments, pull wire 302 may be movably and / or pivotally coupled to pivot connection 290 and / or the second bar member 295 of pivot connection 290. In some embodiments, pull wire 302 may be permanently and / or fixedly attached to at least a portion of pivot connection 290. Other configurations are also contemplated. 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 the pull wire 302, pivot connection 290, and / or elements thereof are described below, such as metallic materials, polymeric materials, ceramic materials, composite materials, etc.

[0071] 14-17, in some embodiments, the cutting blade 260 can be configured to intersect with the suture lumen 250 upon axial movement of the cutting blade 260 from a first position to a second position. 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 the first position. In some embodiments, the first position of the cutting blade 260 can be the proximal position seen in FIGS. 14 and 16, and the second position of the cutting blade 260 can be the distal position seen in FIGS. 15 and 17.

[0072] As shown in FIGS. 14-17, distal 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 actuation of the pivot connection 290) and / or 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 and / or through the suture lumen 250.

[0073] 14 and 16, when the suture 140 extends within the suture lumen 250 and the cutting blade 260 is in a first position, the suture 140 may be axially movable within the suture lumen 250. As shown in FIGS. 15 and 17, when the suture 140 extends within the suture lumen 250 and the cutting blade 260 moves toward a second position (e.g., distally) and / or relative to and / or within the elongate shaft 210 and / or distal tip member 220, the suture 140 may be severed by the cutting blade 260 and / or the sharp cutting edge 266 of the cutting blade 260.

[0074] In some embodiments, the suture 140 may be cut by the cutting blade 260 and / or the sharp cutting edge 266 of the cutting blade 260 when the cutting blade 260 and / or the sharp cutting edge 266 of the cutting blade 260 passes completely through the suture lumen 250, as seen in Figures 14-15.

[0075] In some alternative embodiments, medical device 200 may include a polymer block 272 immovably disposed within longitudinally extending rectangular slot 270. In some embodiments, polymer block 272 may be fixedly attached within longitudinally extending rectangular slot 270. In some embodiments, polymer block 272 may “capture” or receive cutting edge 266 of cutting blade 260 as cutting blade 260 is moved axially distally and / or toward the second position. As seen in FIGS. 16-17 , polymer block 272 may cooperate with cutting edge 266 of cutting blade 260 to function as a shearing surface that cuts suture 140 during and / or as cutting blade 260 and / or cutting edge 266 of cutting blade 260 pass through suture lumen 250. Some suitable, but non-limiting, materials for polymer block 272 are described below.

[0076] In some embodiments, the medical device 200 may include a handle 300. In some embodiments, the handle 300 may include an actuation mechanism or at least a portion of the actuation mechanism. In some embodiments, the handle 300 may include a handle body 310 fixed and / or attached to the proximal end of the elongate shaft 210. In some embodiments, the handle body 310 may be fixedly attached to the proximal end of the elongate shaft 210. The elongate shaft 210 may extend distally from the handle body 310. In some embodiments, the handle 300 may include a grip 320 fixedly attached to the handle body 310. In some embodiments, the handle 300 may include one or more ports 330 attached to the handle body 310 and in fluid communication with the elongate shaft 210.

[0077] In some embodiments, shown in FIG. 18 , the handle 300 can include an actuation lever 340 that is movable relative to the handle body 310. In some embodiments, the actuation lever 340 can be pivotally attached to the handle body 310. In some embodiments, the actuation lever 340 can be fixed to the pull wire 302. In some embodiments, the actuation lever 340 can be fixedly attached to the pull wire 302. The actuation lever 340 can be configured to pivot from a first position to a second position relative to the handle body 310 toward the grip 320 to axially move the pull wire 302 proximally within and / or relative to the elongate shaft 210, thereby shifting and / or axially moving the cutting blade 260 from a first position to a second position (e.g., FIGS. 10-12 and 14-17 ). In some embodiments, the first position can be a proximal position and the second position can be a distal position. Other configurations are contemplated. In some embodiments, the handle 300 may include a locking pin 350 or other locking element insertable into the handle body 310 when the actuating lever 340 is in the first position to prevent movement and / or actuation of the actuating lever 340 relative to the handle body 310 and / or grip 320.

[0078] 19-20 , the handle 300 may include an actuation lever 340 that is movable relative to the handle body 310. In some embodiments, the actuation lever 340 may be axially movable relative to the handle body 310. In some embodiments, the actuation lever 340 may be fixedly attached to the pull wire 302. The actuation lever 340 may be configured to move and / or slide axially from a first position to a second position relative to the handle body 310 to axially move the pull wire 302 within and / or proximally relative to the elongate shaft 210, thereby shifting and / or axially moving the cutting blade 260 from a first position to a second position (e.g., FIGS. 10-12 and 14-17 ). In some embodiments, the first position may be a distal position engaged with and / or adjacent the handle body 310, and the second position may be a proximal position spaced apart from the handle body 310. Other configurations are also contemplated. In some embodiments, the handle 300 may include a locking pin or other locking element insertable into the handle body 310 and / or attachable to the actuation lever 340 when the actuation lever 340 is in the first position to prevent movement and / or actuation of the actuation lever 340 relative to the handle body 310.

[0079] In some embodiments, the handle body 310 may include an internal chamber 312 in fluid communication with one or more ports 330 attached to the handle body 310. In at least some embodiments, the pull wire 302 may pass through the internal chamber 312. In some embodiments, the internal chamber 312 may be 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 and a vacuum source may be connectable to the second port 334, or vice versa. The fluid source may supply a fluid, such as saline or other biocompatible fluid, into the internal chamber 312 and / or the elongate shaft 210, and the vacuum source may aspirate and / or remove air bubbles, debris, contaminants, etc. from the internal chamber 312 and / or the elongate shaft 210. Other configurations are also contemplated. Some suitable, but non-limiting, materials for the handle 300, handle body 310, grip 320, and / or other related components are described below, such as metallic materials, polymeric materials, composite materials, etc.

[0080] The various components of the medical device and materials that can be used for the 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, delivery catheters, elongate shafts, pull wires, handles, distal tip members, rounded distal caps, cutting blades, and / or elements or components thereof.

[0081] In some embodiments, the system and / or its components may be formed of metals, metal alloys, polymers (some examples are described below), metal-polymer composites, ceramics, combinations thereof, etc., or another suitable material.

[0082] Other examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer, or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene terephthalates, polyethylene glycols ... 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., For example, KEVLAR®, polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., AorTech Biomaterials, Inc.),The sheath may comprise a biocompatible polymer, such as Elast-Eon® from AdvanSource Biomaterials or ChronoSil® from AdvanSource Biomaterials, or other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0083] 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.

[0084] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition is about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa Techno Material Co., Ltd., Kanagawa Prefecture, Japan. Other suitable materials include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, can be used to achieve the desired properties.

[0085] 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 during a medical procedure. This relatively bright image assists the user of the system and / or its components 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 design of the system and / or its components to achieve similar results.

[0086] 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 (i.e., 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.

[0087] In some embodiments, the system and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); and anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine). etc.); anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, 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); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0088] 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 arrangement of steps, without departing from the scope of the disclosure. This may include, to the extent appropriate, the use of any feature of one embodiment used in another embodiment. The scope of the disclosure is, of course, defined in the expressed terms 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 disposed at the proximal end of the elongate shaft and including an actuation mechanism; a cutting blade disposed near the distal end of the elongate shaft; the cutting blade is axially movable within the elongate shaft in response to operation of the actuation mechanism; the elongate shaft includes a distal port configured to receive a suture therein; the elongate shaft includes a transverse slot extending inward from an outer surface of the elongate shaft perpendicular to the central longitudinal axis; the elongate shaft includes a suture lumen extending axially through the elongate shaft from the distal port to the transverse slot; the elongate shaft includes a cutting blade lumen offset from the suture lumen, the cutting blade being slidable within the cutting blade lumen; The medical device, wherein the cutting blade intersects the transverse slot adjacent the suture lumen.

2. The medical device of claim 1 , wherein the elongate shaft includes a side port located on an opposite side of the cutting blade from the transverse slot.

3. the transverse slot includes a first proximal wall facing toward the distal end of the elongate shaft; the side port includes a second proximal wall facing toward the distal end of the elongate shaft; The medical device of claim 2 , wherein the second proximal wall is disposed distally of the first proximal wall.

4. The medical device of claim 1 , wherein the cutting blade includes a flat body portion oriented parallel to the central longitudinal axis.

5. The medical device of claim 4 , wherein the cutting blade includes a longitudinally oriented slot extending transversely therethrough.

6. The medical device of claim 5 , wherein the cutting blade further includes a sharp cutting edge on the distal end of the cutting blade and facing toward the proximal end of the elongate shaft.

7. The medical device of claim 6 , wherein proximal axial movement of the cutting blade relative to the elongate shaft moves the sharp cutting edge toward the transverse slot.

8. The medical device of claim 7 , wherein the sharp cutting edge is configured to cooperate with the transverse slot to sever a suture extending through the longitudinally oriented slot of the cutting blade.

9. 4. The medical device of claim 1, wherein the elongate shaft includes a rounded distal cap secured to the distal end of the elongate shaft, the rounded distal cap including the distal port.

10. The actuation mechanism includes a pivotal connection adjacent the distal end of the elongate shaft, the pivotal connection being connected to the cutting blade; The medical device of claim 1 , wherein the cutting blade is configured to intersect the suture lumen upon axial movement of the cutting blade from a first position to a second position.

11. The medical device of claim 10 , wherein the cutting blade is slidably disposed within a longitudinally extending rectangular slot.

12. The medical device of claim 11 , wherein the cutting blade includes a sharp cutting edge facing distally.

13. The medical device of claim 12, further comprising a polymer block non-movably disposed distally within the longitudinally extending rectangular slot of the cutting blade.

14. 14. The medical device of claim 10, wherein the pivot connection includes a central pivot point and a slot extending radially from the central pivot point and configured to slidably engage a pin coupled to the cutting blade.

15. 14. The medical device of any one of claims 10-13, wherein the suture is movable within the suture lumen when the cutting blade is disposed in the first position.

Images