Surgical knot pusher

Abstract

A knot pusher (10) comprises a tubular suture holder (12) provided with a tubular wall provided with a suture receiving slot (20) in which a spindle (22) is axially movable, said suture receiving slot (20) preferably comprising a narrow distal slot portion, a first transition region and a second transition region, the first transition region begins from a first distance from a distal tip, where a first edge (26) is formed offset from a second edge (28) of the slot extending in an axial direction, and the second transition region begins from a further distance from the distal tip, where the second edge is offset from the first edge in the axial direction, where the second edge is formed offset from the second edge in the axial direction. This defines a chute through the tubular suture fixture and for receiving a suture.

Description

[0001] FIELD AND BACKGROUND OF THE INVENTION

[0002] The present invention relates to surgical devices, and more particularly to a device for advancing and tightening suture knots.

[0003] Many surgical techniques utilize sutures that must be knotted. In many cases, this is accomplished by using a knot pusher to push a sliding knot along one side of the suture, known as a "track line." Once in place, the knot is converted to a locking knot, known as a "locking line," by applying additional tension to the other line. Summary of the invention

[0004] The present invention is a knot pusher.

[0005] According to the teachings of an embodiment of the present invention, a knot pusher for pushing a knot along a suture is provided, the knot pusher comprising: (a) a tubular suture holder having a tubular wall, the tubular wall defining an inner hole, the inner hole having a central longitudinal axis and terminating at a distal tip, the tubular suture holder having a suture receiving slot formed through the tubular wall and extending proximally from the distal tip so that a section of a suture is loaded into the inner hole through the suture receiving slot, and a continuation of the suture is exposed from the distal tip; and (b) a mandrel axially movable in the inner hole, the mandrel biased from a retracted position toward an advanced position, in which the suture receiving slot allows a section of a suture to be loaded into the inner hole through the suture receiving slot, and a continuation of the suture is exposed from the distal tip, and in the advanced position, the mandrel blocks a distal end of the suture receiving slot so as to retain the section of the suture in a portion of the inner hole, and the continuation of the suture is exposed from the distal tip. Extending from the distal tip and a proximal end of the suture receiving groove, the mandrel defines a channel within the portion of the inner bore to allow the suture to slide along the channel; wherein the suture receiving groove includes: (i) a distal groove portion, adjacent to the distal tip, and formed with a first edge and a second edge, the first edge and the second edge being separated by a first width, the first width being at an angle of less than 30 degrees to the central longitudinal axis; (ii) a first transition region, beginning at a first distance from the distal tip, the first edge being formed to deviate from the second edge, and the second edge extending along an axial direction; and (iii) a second transition region, beginning at a second distance from the distal tip, the second distance being greater than the first distance, the second edge deviating from the first edge from the axial direction, the first edge in the first transition region and the second edge in the second transition region defining at least a portion of an oblique groove, at least a portion of the oblique groove traversing the tube wall and for receiving a suture.

[0006] According to further features of an embodiment of the present invention, the oblique groove corresponds to an opening passing through the tube wall, multiple angular ends of the tube wall form a groove angle between 120 degrees and 240 degrees around the central longitudinal axis, and an angular position of the distal groove portion forms an angular interval of at least about 20 degrees with multiple ends of the oblique groove.

[0007] According to further features of an embodiment of the present invention, a maximum depth of the oblique groove defines a baseline of the oblique groove, a base plane of the oblique groove is defined as a plane containing the baseline and parallel to the central axis, and the second edge at the beginning of the second transition area provides a suture capture protrusion, and the suture capture protrusion is located at a height X from the base plane, wherein the height X is greater than the first width.

[0008] According to further features of embodiments of the present invention, the height X is at least 30% of the radius of the tube wall of the tubular suture anchor.

[0009] According to further features of an embodiment of the present invention, the distal tip of the tubular suture anchor forms an end closure member, which closes most of the area of ​​the inner hole, and the end closure member includes a radial groove, which is adjacent to the distal groove portion of the suture receiving groove, and the radial groove terminates in a retaining hole, and a transverse dimension of the retaining hole is greater than the first width.

[0010] According to further features of an embodiment of the present invention, the mandrel terminates in at least one protruding finger, a cross-sectional area of ​​the protruding finger is smaller than half of a cross-sectional area of ​​the mandrel near the protruding finger, and the protruding finger is deployed so that when a suture is captured by the mandrel in the suture receiving groove, the tension in the suture tends to retract the mandrel toward the retracted position, causing the suture to engage with the protruding finger to inhibit the release of the suture and apply force to the suture to return the suture toward the distal tip.

[0011] According to further features of embodiments of the present invention, the knot pusher further comprises an axially displaceable cutting element, which is located outside or inside the tubular suture holder and is selectively displaceable in a distal direction to cut a suture exiting through a proximal end of the suture receiving groove.

[0012] According to further features of an embodiment of the present invention, the knot pusher also includes a handle supporting the tubular suture holder, the handle having a manually operable slider device and an associated spring device, the spring device including at least one spring, the manually operable slider device being configured such that an axial force applied to the slider device in a first axial direction acts on the spring device to displace the spindle from the advanced position to the retracted position, and an axial force applied to the slider device in a second axial direction opposite to the first axial direction acts on the spring device to displace the cutting element to cut a suture exiting through a proximal end of the suture receiving slot, wherein the slider device is locked by a locking configuration to prevent displacement in the first axial direction, and a release element of the slider device is configured such that an initial displacement of the release element in the first axial direction effectively unlocks the locking configuration before displacement of the spindle.

[0013] According to the teachings of the embodiments of the present invention, there is also provided a knot pusher for pushing a knot along a suture, the knot pusher comprising: (a) a tubular suture anchor having a tube wall, the tube wall defining an inner hole, the inner hole having a central longitudinal axis and terminating at a distal tip, the tubular suture anchor having a suture receiving groove, and the suture receiving groove is formed through the tube wall and extends proximally from the distal tip, the suture receiving groove comprising a distal groove portion and an oblique groove, the distal groove portion being close to the distal tip and forming a first edge and a second edge, the first edge and the second edge being separated by a first width, the oblique groove being close to and adjacent to the distal groove portion, the oblique groove having a width greater than the first width and being used to receive a suture; and (b) a mandrel that can move axially in the inner hole, the mandrel being biased to a An advanced position, in which the mandrel blocks a distal end of the suture receiving slot so as to slidably capture a suture that enters the inner hole at the distal tip and exits through the bevel slot, and the mandrel can be retracted to a retracted position, in which the suture receiving slot is open to receive a suture; wherein the mandrel terminates in at least one protruding finger, the protruding finger having a cross-sectional area that is less than half of a cross-sectional area of ​​the mandrel near the protruding finger, the protruding finger being deployed so that when a suture is captured by the mandrel in the suture receiving slot, tension in the suture tends to retract the mandrel toward the retracted position, causing the suture to engage with the protruding finger to inhibit release of the suture, and applying force to the suture to return the suture toward the distal tip.

[0014] According to the teachings of the embodiments of the present invention, a knot pusher for pushing a knot along a suture is also provided, the knot pusher comprising: (a) a tubular suture anchor having a tubular wall, the tubular wall defining an inner hole, the inner hole having a central longitudinal axis and terminating at a distal tip, the tubular suture anchor having a suture receiving groove, the suture receiving groove being formed through the tubular wall and extending proximally from the distal tip, the suture receiving groove comprising a distal groove portion and an oblique groove, the distal groove portion being close to the distal tip and being formed with a first edge and a second edge, the first edge of the first suture anchor having a central longitudinal axis and terminating at a distal tip, the suture receiving groove comprising a distal groove portion and an oblique groove, the distal groove portion being close to the distal tip and being formed with a first edge and a second edge, the first edge of the first suture anchor having a central longitudinal axis and terminating at a distal tip, the suture receiving groove comprising a distal groove portion and an oblique groove, the distal groove portion being close to the distal tip and being formed with a first edge and a second edge, the first edge of the first suture anchor having a central longitudinal axis and terminating at a distal tip, the suture receiving groove comprising a distal groove portion and a .... (a) a mandrel that is axially movable in the inner hole, the mandrel being biased to an advanced position in which the mandrel blocks a distal end of the suture receiving groove so as to slidably capture a suture that enters the inner hole at the distal tip and exits through the beveled groove, the mandrel being retractable to a retracted position in which the suture receiving groove is open to receive a suture; c) an axially displaceable cutting element located outside or inside the tubular suture holder and selectively displaceable in a distal direction to cut a suture exiting through a proximal end of the suture receiving slot; and (d) a handle supporting the tubular suture holder, the handle having a manually operable slider means and associated spring means, the spring means including at least one spring, the manually operable slider means being configured such that an axial force applied to the slider means in a first axial direction acts on the spring means to displace the mandrel from the advanced position to the retracted position, and an axial force applied to the slider means in a second axial direction opposite the first axial direction acts on the spring means to displace the cutting element to cut a suture exiting through a proximal end of the suture receiving slot; wherein the slider means is locked against displacement in the first axial direction by a locking arrangement, a release element of the slider means being associated with the locking arrangement such that an initial displacement of the release element in the first axial direction is effective to unlock the locking arrangement prior to displacement of the mandrel. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The present invention is described, by way of example only, with reference to the accompanying drawings, in which:

[0016] Figure 1A and Figure 1B Front and rear isometric views, respectively, of a knot pusher and suture cutter, constructed and operative in accordance with embodiments of the present invention.

[0017] FIG. 2A to FIG. 2C They are from Figure 1A Isometric view of the tubular suture holder, mandrel assembly, and cutting element of the knot pusher and suture cutter.

[0018] Figure 3A yes Figure 2A Schematic diagram of the distal end portion of a tubular suture anchor, showing the form of a suture receiving groove according to an embodiment of one aspect of the present invention.

[0019] Figure 3B is along Figure 3A A schematic cross-sectional view taken along line AA.

[0020] Figure 3C is similar to Figure 3B The view shows Figure 3A Varying geometries of suture receiving grooves.

[0021] FIG. 4A to FIG. 4D Insert the suture into Figure 1A Schematic representation of the successive stages of the knot pusher process.

[0022] Figure 5A yes Figure 1A Schematic diagram of a knot pusher used to push a sliding knot along a track thread during suture tightening.

[0023] Figure 5B and Figure 5C Schematic enlargements of the sliding knot during pushing and after locking, respectively.

[0024] Fig. 6A and Figure 6B are side views of two embodiments of suture-receiving channels.

[0025] 7A to 7C Is to display the suture into Figure 1A Isometric view of the stages in a knot mover.

[0026] Figure 8 is an isometric view showing the force a user would preferably apply when tightening a knot during a surgical procedure.

[0027] Fig. 9A is Figure 8 Magnified view of the distal tip of the knot pusher in its original state.

[0028] Fig. 9B is similar to Fig. 9A View of the suture cutting element during operation.

[0029] Fig. 10A is an isometric view of the distal portion of the tubular suture holder and mandrel when separated.

[0030] Fig. 10B is a partially cutaway isometric view of the assembled knot pusher showing the path of the loaded suture through the tubular suture holder.

[0031] FIG. 11A to FIG. 11C yes Figure 1A Isometric views of the distal end of the mandrel of the knot pusher in , showing variations of the mandrel tip having two protruding fingers, one protruding finger, and a flat end, respectively.

[0032] FIG. 12A to FIG. 12C They are respectively FIG. 11A to FIG. 11C Top view of the distal end of the knot pusher for each implementation of the mandrel.

[0033] Fig.13A and Fig. 13B Under the condition of excessive unexpected retraction force Fig. 12A Schematic isometric view of the distal end of the knot pusher in FIG, with the suture gate closed and partially opened due to retraction forces.

[0034] FIG. 14A to FIG. 14C yes Fig. 12A Schematic top view of the distal end of the knot pusher in , showing the various stages during the loading of suture into the knot pusher with the assistance of the distal displacement of the mandrel.

[0035] FIG. 15A to FIG. 15D yes Figure 1A Isometric views of the handle of the knot pusher in , showing the configuration of the slider device in the locked state, unlocked state, mandrel retracted state and suture cutting state, respectively.

[0036] FIG. 16A to FIG. 16D yes Figure 1A Isometric view of the distal end of the knot pusher in FIG. 15A to FIG. 15D Each state in corresponds to a configuration of the knot pusher.

[0037] Fig.17 yes Figure 1A A side view of the knot pusher with the handle's body half shell removed to show the internal components.

[0038] Fig.18 yes Figure 1A Plan view of the knot pusher in Fig.

[0039] 19A to 19D is along Fig.18 The cross-sectional views taken along the line XIX-XIX in correspond to FIG. 15A to FIG. 15D status.

[0040] Fig. 20A and Fig. 20B yes Figure 1AAn enlarged isometric view of the slider assembly of the knot pusher in FIG. 1 , showing the locked configuration in the locked and unlocked states, respectively.

[0041] Fig. 20C yes Fig. 20B Magnified view of the area marked XX in FIG.

[0042] Fig.21 is used for Figure 1A Schematic side view of an alternative slider arrangement in a knot pusher.

[0043] Fig.22A and Fig. 22B is based on Figure 1A Partially cut away isometric views of a distal portion of a knot pusher of an alternative embodiment in which a cutting element is internally deployed to a tubular suture holder, showing the cutting element in a retracted and distally deployed cutting position, respectively.

[0044] Fig. 22C is similar to Fig. 22B Uncut view.

[0045] Fig.23A and Fig. 23B Front and rear isometric views, respectively, of a knot pusher and suture cutter, constructed and operative in accordance with another embodiment of the present invention, configured for use with a flying lead having a guide wire.

[0046] FIG. 24A to FIG. 24D yes Fig.23A Isometric views of the handle of the knot pusher in , showing the configuration of the slider device in the locked state, unlocked state, mandrel retracted state and suture cutting state, respectively.

[0047] FIG. 25A to FIG. 25D yes Fig.23A An isometric view of the distal end of the knot pusher showing the FIG. 24A to FIG. 24D Each state corresponds to a configuration of the knot pusher. DETAILED DESCRIPTION

[0048] The present invention is a knot pusher for pushing a knot along a suture, preferably integrated with a suture cutter.

[0049] The principles and operation of a knot pusher according to the present invention may be better understood with reference to the drawings and accompanying description.

[0050] With reference to the accompanying drawings, Figures 1A to 25D A knot pusher, generally designated 10 or 10', for pushing a knot along a suture is shown constructed and operative in accordance with various embodiments of the present invention.

[0051] In general, with reference to all of the variations of the drawings, knot pusher 10 comprises a tubular suture holder 12 having a tubular wall defining an inner bore 14 having a central longitudinal axis 16 and terminating in a distal tip 18. The tubular suture holder 12 has a suture receiving slot 20 formed through the tubular wall and extending proximally from the distal tip 18. A mandrel 22 is movable within the inner bore 14 to a closed position (best seen in FIG. 1 ). Figure 7C , Fig. 10B and Fig.16A ) and an open position (best seen in Fig. 7A , Figure 7B and Fig. 16C ), wherein the mandrel 22 blocks the distal end of the suture receiving slot 20, thereby slidably clamping a section of a suture 100 in the inner hole, so that the continuation of the suture is exposed from the distal tip 18 and the proximal end of the suture receiving slot 20, wherein the suture receiving slot 20 is opened to load the section of the suture 100. The suture receiving slot 20 together with the mandrel 22 is referred to herein as a "suture gate" (SG), which is opened or closed according to the corresponding position of the mandrel 22. The displacement of the mandrel 22 is generally axial, wherein the mandrel is biased toward an advanced (distal) closed position and can be selectively retracted to a retracted (proximal) open position, although certain aspects of the present invention are also applicable to mandrels that perform rotational movement or any other more complex movement between open and closed positions.

[0052] The general operation and function of the knot pusher 10 is generally as follows. With the mandrel 22 retracted, one or more lengths of suture are loaded into the suture receiving channel 20 (e.g., by a sequence described in more detail below) so as to be located within a portion of the inner bore 14 from a proximal region of the suture receiving channel 20 to the distal tip 18 of the tubular suture anchor 12, such as Figure 7B Then, the mandrel 22 is shifted to its closed position, and the suture door is closed to capture the suture. The mandrel 22 is shaped to define a channel within a portion of the inner hole 14, such as Fig. 10B As shown, in order to allow the suture 100 to slide along the inner hole, or in other words, to allow the knot pusher to slide along the suture. FIG. 5A to FIG. 5C , Figure 8 and Fig. 9AAs shown, a knot pusher can be used to engage and advance along one or more track threads 102, thereby pushing a sliding knot (sliding hitch) 104 along the track threads while applying tension to the track threads, thereby tightening a loop 106 that performs whatever function the suture is intended to perform (e.g., holding two tissue regions together or tightening an object 108). Once the loop is properly tightened, additional tension applied to a locking thread 110 (while the track threads 102 remain under tension) converts the sliding knot into a locking knot ( Figure 5C ). If multiple knots are required, the knot pusher can be used to form and tighten more knots. Finally, in a particularly preferred embodiment, wherein the knot pusher also includes a cutting element 24, the track thread 102 is released by opening the suture gate, and all sutures are reloaded into the suture gate. The knot pusher is then slid down the suture to the desired cutting position, and the cutting element (described below) is activated to cut the suture above the knot ( Fig. 9B ).

[0053] Various aspects of the present invention further elaborate on the above-mentioned specific structures and functions. The first aspect of the present invention provides a particularly advantageous form of suture receiving groove 20, while the second aspect of the present invention provides a particularly advantageous form of mandrel 22. The third aspect of the present invention provides a handle having a particularly preferred implementation of a user interface for operating a knot pusher. The fourth aspect of the present invention relates to a configuration of a knot pusher that can be used on an over-the-wire (OTW) where there is a guide wire that can be used to guide the device to the position where the knot is to be tightened. Each of these aspects of the present invention can be used alone to advantage, and the implementation of the knot pusher is substantially different from the other aspects of the present invention described herein. However, some or all of these various aspects of the present invention are considered to be particularly suitable for implementation in a single device to provide a particularly advantageous combination of features, as described below.

[0054] Turning now to the preferred form of the suture receiving slot 20, as shown Figure 3A is schematically shown in Fig. 6A and Figure 6B 1 and 2. The suture receiving groove 20 is shown in a non-limiting preferred exemplary embodiment. The suture receiving groove 20 preferably includes a distal groove portion, which is adjacent to the distal tip 18 and is formed with a first edge 26 and a second edge 28, and the first edge 26 and the second edge 28 are separated by a first width W. The first width W is relatively narrow, preferably forming an angle of less than 30 degrees with the central longitudinal axis 16, and is typically 5 to 20 degrees. The width must be sufficient to allow the suture (regardless of the thickness used) to pass through. A width of 1 to 2 mm is generally sufficient, and in many cases, the distal groove portion can be a sub-millimeter width groove.

[0055] A first transition region of the suture receiving slot 20 begins at a first distance L1 from the distal tip 18, wherein the first edge 26 is formed at point "d" so as to deviate from the second edge 28, which itself extends along an axial direction another distance Δ to point "c". The term "axial" is used in the description and claims herein to refer to a direction that is visually parallel to the central axis 16, which allows for imperfect alignment (e.g., up to about ±20 degrees from the axis), and does not require that the second edge 28 is completely straight. A second transition region begins at point "c", a second distance L2 (equivalent to L1+Δ) from the distal tip, wherein the second edge 28 deviates from the first edge 26 from the axial direction.

[0056] The first edge 26 in the first transition region and the second edge 28 in the second transition region define at least a portion of an oblique channel extending through the tube wall to receive a suture. Figure 3B and Figure 3C The importance of this structure can be appreciated, where the oblique slot is a portion of the visible cylindrical wall, which is visible as an opening in the cross-sectional view. This allows the suture to be inserted through the slot to a "maximum depth" corresponding to the base line 30 of the slot, from area "a" of edge 26 to area "b" of edge 28. Figure 3B and Figure 3C As shown, a point "c" corresponding to the area of ​​the second edge 28 where the second transition area begins provides a suture capture projection (local projection area) at a height X from the base line 30 (or more precisely, a base plane passing through the base line 30 and parallel to the central axis 16). The height X is preferably greater than the first width W of the distal groove portion, and is preferably at least 30% of the tube wall radius R of the tubular suture anchor. The height is staggered with the groove, wherein point "d" is closer to the distal tip than point "c", providing an efficient geometry for capturing the suture for insertion into the device.

[0057] FIG. 4A to FIG. 4D A typical sequence for capturing a suture and inserting it along the slot is shown. The knot pusher is placed close to the suture to be joined ( Figure 4A ) and position it so that the suture spans the bottom of the groove ( Figure 4B ). In this position, the suture capture projection "c" is raised above the suture, thereby facilitating capture of the suture, typically by rotational movement of the knot pusher, such as Figure 4C Once the suture is captured on protrusion "c", further rotation of the knot pusher causes the suture to slide along edge 28 and pass through the narrow distal slot to be guided to the Figure 4DThe suture is then positioned in a position ready for closing the door by displacement of the mandrel (not shown here). Although presented here in a sequence of steps / positions, the entire sequence is generally intuitively formed in a quick single action. Unlike various conventional knot pushers, this suture capture movement can be performed without the need for rotation of the device about its longitudinal axis, making operation simple and intuitive.

[0058] The depth of the groove is preferably a relatively large portion of the thickness of the tube wall while leaving a sufficient portion of the tube wall to provide structural integrity. Typically, an oblique groove corresponds to an opening through the tube wall that encloses a groove angle α of between 120 degrees and 240 degrees about the central longitudinal axis, which can occur at the same axial position along the groove or can be staggered, measured from the angular extremities of the first edge 26 and the second edge 28. Even though these angular extremes occur at the same axial position along the groove, the groove is still referred to as an "oblique" groove due to the asymmetry between edges 26 and 28, with edge 26 extending further outward than edge 28. A particular feature of certain particularly preferred embodiments of the present invention is that the angular position of the distal groove portion (e.g., defined as the midpoint on the chord between "c" and "d" relative to the central longitudinal axis) is angularly spaced at least about 20 degrees from the end of the oblique groove. Figure 3B In the example of Figure 3C In the embodiment of the present invention, the distal groove portion is asymmetrically positioned relative to the groove angle. As long as the distal groove portion is significantly spaced from the end of the groove angle, such as at least about 20 degrees, the suture capture projection "c" will be sufficiently elevated above the resting position of the suture in the groove to facilitate reliable capture of the suture. The height of point "d" above the groove base line also defines an obstacle that is easily overcome when inserting the suture, such as by referring to the above Figure 4C and Figure 4D The described rotational motion, however, helps reduce the likelihood that the suture will inadvertently come out of the distal slot during use because the slot is generally facing upward rather than in the direction that would normally apply tension to the suture ends.

[0059] To facilitate pushing the knots in, make sure they do not enter the inner hole of the tubular suture holder, e.g. Figure 3B , Figure 3C and Fig. 10AAs shown, the distal tip of the tubular suture anchor is preferably formed with an end closure 32, which closes off a majority of the inner bore. The end closure 32 includes a radial slot 34 adjacent to the distal slot portion of the suture receiving slot 20 and generally having a width W similar to the distal slot portion. The radial slot 34 preferably terminates in a retaining hole 36 having a transverse dimension greater than the first width W. Thus, for example, the distal slot portion and the radial slot may have a first width W that is sized to allow a single suture to pass through the slot, and the retaining hole 36 is preferably large enough to receive all suture ends used, such as when the suture ends are loaded for cutting. If a double strand suture is used, it may be necessary to introduce four strands of suture at a time while still fitting tightly enough to prevent a slip knot from entering the inner bore. The radial slot 34 and the retaining hole 36 generally form a keyhole slot shape together.

[0060] Turning now to the features of certain preferred embodiments of the spindle 22, Fig. 10A and Fig.11A A particularly preferred but non-limiting example is shown. The portion of the mandrel 22 that reaches at least the area of ​​the suture receiving groove 20 is formed with a notch, channel or cutout 38, which together with the wall of the tubular suture holder 12 defines a channel between the distal tip 18 and the proximal end of the bevel, through which the suture can slide, such as Fig. 10B The cutout 38 (so-called cutout 38 is to describe its shape without limiting the device to any particular production technology) can be a flat surface corresponding to a cutout that is less than half of a cylinder. In this case, a distal chamfered surface 40 can advantageously provide additional clearance to allow the suture to run freely through the retaining hole 36.

[0061] According to another aspect of the present invention, according to certain particularly preferred embodiments, the mandrel 22 terminates in at least one protruding finger 42 having a cross-sectional area that is less than half of the cross-sectional area of ​​the protruding finger 42 proximal to the mandrel 22. Fig. 10A and Fig.11A In the example of the embodiment of the present invention, the mandrel 22 has two protruding fingers 42, and thus, the mandrel 22 can alternatively be viewed as a bifurcated tip, or as a tip having a groove or "notch" 44. The notch 44 is preferably aligned with the distal slot portion, so that tension applied to the suture acts to pull it through the distal slot portion in the opposite direction, tending to engage the suture with the notch 44. The notch 44 is preferably sized to simultaneously receive all the thicknesses of suture that may be loaded into the knot pusher during the tightening of the knot.

[0062] The resulting functions are as follows Fig.13A and Fig. 13BAs shown. In various situations, particularly if the tip of the knot pusher is inserted deeper into the target tissue than the suture tissue, the tension applied by the user on the track line and the locking line may cause significant proximal forces to be applied directly to the suture gate. Since the distal slot is positioned toward the "top" of the tip of the knot pusher, in most cases, these forces act on the sides of the retaining hole 36. However, in some cases, if the suture is aligned with the distal slot, these proximal forces may force the mandrel 22 to retract and possibly cause the suture to come out. The protruding fingers 42 and the notches 44 help prevent the suture from coming out.

[0063] Specifically, when a suture 100 is trapped by the mandrel 22 in the suture receiving groove 20, as previously described, the tension in the suture tends to retract the mandrel to the retracted position, causing the suture to engage the protruding fingers 42 (e.g., in the notches 44), thereby inhibiting the release of the suture. Fig. 13B As shown, the increased force may cause the mandrel 22 to retract, but the tension maintains the engagement of the suture 100 with the notch 44 so that the suture does not slip out of the suture door. When the situation of excessive retraction force (e.g., over-insertion, etc.) is improved, the spring bias for advancing the mandrel 22 can effectively restore the normally closed state of the suture door.

[0064] FIG. 14A to FIG. 14C The above preferred features show additional possible functions of the mandrel 22. Although the above ( FIG. 4A to FIG. 4D ) describes the process of inserting the suture 100 into the suture receiving slot 20, which is performed by manipulating the tubular suture holder 12 while the mandrel 22 is retracted and the suture door is open, but certain preferred embodiments of the mandrel 22 described herein facilitate loading the suture into the knot pusher. Specifically, as before, when the mandrel 22 is retracted, the suture 100 is inserted across the oblique slot (such as Fig.14A When the mandrel 22 is released to return to its distal position, one of the protruding fingers 42 engages the suture 100 ( Fig. 14B ) and carry it distally so as to be passed along the suture receiving groove 20 to the engagement position, and the suture door is closed, as shown in FIG. Fig. 14C shown.

[0065] Fig.11A The dual finger configuration is particularly suitable for the form of the above-mentioned slot 20, providing support to prevent the suture from sliding into the bevel slot from either direction. Fig. 11B An alternative configuration with a single protruding finger 42 is shown in FIG. This configuration may be optimal for a knot pusher having a straight-sided groove 20′, such as Fig. 12BAs shown, the edge of the groove prevents the suture from sliding out of one side, and a single protruding finger 42 is sufficient to keep the suture from sliding toward the open proximal region of the groove. In this case, the mandrel 22 can be considered to have a stepped end. The configuration also provides FIG. 13A to FIG. 13B and FIG. 14A to FIG. 14C The functions described.

[0066] The features of the mandrel 22 described herein may be used with the features of the suture receiving slot 20 described above, but are not limited to use in this combination. Thus, for example, the suture receiving slot 20 may also be used with a mandrel that does not have protruding fingers, such as Fig. 11C and Fig. 12C In contrast, Fig.11A and 11B The mandrel can be used with a knot pusher that employs a conventional suture receiving slot, wherein the protruding fingers 42 and / or notches 44 are deployed in a properly aligned manner into the slot at the distal end of the suture gate to prevent the suture from slipping out if excessive tension is aligned with the gate.

[0067] Although the features of knot pusher 10 described thus far can be implemented in a knot pusher without a suture cutting feature, it is believed to be particularly beneficial to combine knot pusher functionality with suture cutting capabilities. To this end, certain preferred embodiments of the present invention include cutting element 24, which is generally implemented as a cylindrical tube ( Figure 2C ). In the embodiments described thus far, the cutting element constrains the tubular suture holder 12 from the outside. The cutting element 24 is biased to a retracted (proximal) position and as shown Fig. 9B The cutting element 24 can be selectively displaced in the distal direction to cut the suture separated by the proximal end of the suture receiving groove 20. When the cutting element 24 is the outermost element of the device shaft, it is preferably provided with a series of depth indicators (e.g., Figure 2C ) to facilitate insertion of the knot pusher to the correct depth during minimally invasive surgery. FIG. 22A to FIG. 22C In the illustrated alternative embodiment, the cutting element 24 is disposed internally to the tubular suture holder 12, the functionality of which remains essentially unchanged.

[0068] Another aspect of the invention relates to a knot pusher and suture cutter that provides an advantageous user interface for operating the knot pusher and suture cutter, with self-locking and easy release features. This aspect of the invention will be described in the context of a knot pusher and suture cutter incorporating the other aspects of the invention described above, by way of a non-limiting example. However, this aspect of the invention may also be used with a knot pusher and suture cutter having a tubular suture holder, the suture receiving slot of the tubular suture holder may be in a different form than described above, and has a different form of displaceable mandrel for opening and closing the suture gate, and an axially displaceable cutting element located outside or inside the tubular suture holder.

[0069] Generally speaking, the knot pusher and suture cutter according to this aspect of the invention includes a handle 46 that supports the tubular suture holder 12, and a manually operable slide assembly 48 for controlling the operation of the mandrel and cutting element.

[0070] The manually operable slider device 48 is configured such that an axial force F1 ( FIG. 15A to FIG. 15B ) acts on the spring means to displace the spindle 22 from its advanced (closed) position to its retracted (open) position, and an axial force F2 applied to the slider means 48 in a second axial direction opposite to the first axial direction acts on the spring means to displace the cutting element 24, thereby cutting the suture separated through the proximal end of the suture receiving slot 20 (as described above with reference to Fig. 9B described above).

[0071] A particularly preferred feature of certain embodiments of this aspect of the invention is that the slider device 48 includes a locking configuration that locks the spindle to prevent displacement in a retraction direction, thereby preventing the spindle from retracting due to tension applied to the end of the suture, and the locking configuration is released by an initial movement caused by manual displacement of the release element 50 in a first axial direction at the beginning of the spindle opening movement, and then the spindle itself moves.

[0072] Figures 17 to 20C The internal components of the slider arrangement and spring arrangement according to a particularly preferred but non-limiting exemplary embodiment are shown. In this case, the slider arrangement 48 includes a first slider 52 that is mechanically connected to the spindle 22 and is biased to a forward (distal) position by the spindle spring 54, and a second slider 56 that can be deployed to move the cutting element 24 and is biased to a retracted position by the cutting element spring 58.

[0073] The locking arrangement prevents accidental retraction of the spindle 22 and is implemented here as one or more resilient blocking elements 60, which are associated with the first slide 52 and are deployed to abut against a shoulder 62 formed in the body of the handle 46, as shown in FIG. Fig.19A In this implementation, the second slider 56 provides a protruding surface that protrudes slightly in the distal direction from the contact surface of the first slider 52 in the static state of the mechanism to provide a manually movable release element 50. When manual pressure is applied to the release element 50 (usually by the user's thumb), the first stage of movement aligns the release element 50 with the first slider 52 (from the FIG. 19A to FIG. 19B ), which effectively deflects the resilient blocking element 60 sufficiently to pass the shoulder 62, thereby unlocking the locked configuration. Further movement of the user's thumb can then effectively displace the first slider 52 (along with the second slider 56) in the proximal direction, against the spindle spring 54, thereby pulling the spindle 22 proximally to open the suture door, as previously described. When the slider is released, the spindle spring 54 returns the slider to its initial position, thereby advancing the spindle 22 to its closed position, closing the suture door and reengaging the locked configuration.

[0074] FIG. 20A to FIG. 20C More details of a non-limiting but particularly preferred embodiment of the release mechanism are shown in more detail. The resilient blocking element 60 shown herein has an integrally formed wedge-shaped structure 64, and the second slider 56 has an associated actuator rod 66, which has a lateral protrusion 68 that is deployed to interact with the wedge-shaped structure 64. When the release element 50 is displaced proximally, the lateral protrusion 68 passes upward over the wedge-shaped structure 64, thereby pressing the resilient blocking element 60 down enough to pass over the blocking shoulder 62 of the housing. After the first slider 52 is released and returned to its distal position, the second slider 56 is returned to its forward position by the elastic force of the blocking element 60 acting on the lateral protrusion 68, thereby relocking the spindle 22 to prevent retraction.

[0075] When the second slider 56 is manually pushed toward the distal direction ( Fig.19D ), which forces flange 70 associated with the cutting element tube in a distal direction against cutting element spring 58, thereby advancing the cutting element to cut the suture, as described above.

[0076] Although the slider arrangement and spring arrangement described so far employs two discrete slider elements and two discrete springs to control the movement of the spindle 22 and the cutting element 24, the above operating principle can also be implemented in a simpler manner using a single slider controlled by two springs or a single spring. Fig.21A schematic diagram showing a possible spindle locking mechanism. Movement of the spindle 22 is blocked by a locking bar 72 which holds the spindle flange 74 against retraction. A slide block 76 is positioned with a small "idle" distance from the spindle flange 74 and has a protruding release tab 78 which is positioned so that when the slide block 76 is moved toward the spindle flange 74, the release tab 78 presses against the locking bar 72 and lifts it from the spindle flange, thereby releasing the flange so that the spindle 22 is displaced by further movement of the slide block 76. The mechanism is shown in a highly schematic manner and without details of the spring or spring assembly and cutting element flange. However, it will be apparent that a single slider implementation of a spindle locking mechanism including release by initial movement of a manually operated slide block could be readily implemented by one of ordinary skill in the art based on the teachings of the present invention.

[0077] Turning now to the fourth aspect of the invention, which may be used alone or in combination with any and all other aspects of the invention described above, this relates to the "over-the-wire" (OTW) implementation of a knot pusher and / or suture cutter, which is guided to the desired location by a guide wire 82. Many minimally invasive surgical procedures use guide wires to guide various tools or implants to the target location. In some cases, when a guide wire is already in place from a previous stage of the surgery, it may be very helpful to use a guide wire to guide the knot pusher to achieve precise guidance of the knot pusher to the target location.

[0078] According to this aspect of the invention, the knot pusher 10' is formed with a guide wire lumen 80 that extends along and generally within the tubular suture anchor 12 and preferably extends from one end of the entire device to the other end. The knot pusher may include any, all, or none of the features described above in connection with the various other aspects of the invention. By way of non-limiting example, FIG. 23A to FIG. 25D It is shown how OTW implementation can be integrated with the other features described above by implementing a guidewire lumen along the lower portion of the tubular suture anchor 12 .

[0079] To facilitate manipulation of the apparatus to insert the suture into the suture portal, this may advantageously be accomplished prior to introducing the guide wire into lumen 80 .

[0080] It should be understood that the above description is by way of example only and that many other embodiments are possible within the scope of the invention as defined by the appended claims.

Claims

1. A knot pusher for pushing a knot along a suture, characterized in that: The knot pusher comprises: (a) a tubular suture anchor having a tubular wall defining an inner bore having a central longitudinal axis and terminating in a distal tip, the tubular suture anchor having a suture receiving slot formed through the tubular wall and extending proximally from the distal tip such that a section of a suture is received through the suture receiving slot into the inner bore and a continuation of the suture emerges from the distal tip; and (b) a mandrel that moves axially within the inner bore, the mandrel being biased from a retracted position toward an advanced position, in which the suture receiving slot allows a section of a suture to be loaded into the inner bore through the suture receiving slot while a continuation of the suture emerges from the distal tip, in which the mandrel blocks a distal end of the suture receiving slot so as to retain a section of the suture within a portion of the inner bore while the continuation of the suture extends from the distal tip and a proximal end of the suture receiving slot, the mandrel defining a channel within the portion of the inner bore to allow the suture to slide along the channel; Wherein the suture receiving groove comprises: (i) a distal groove portion, adjacent to the distal tip, and formed with a first edge and a second edge, the first edge and the second edge being separated by a first width, the first width forming an angle of less than 30 degrees with the central longitudinal axis; (ii) a first transition region beginning at a first distance from the distal tip, the first edge being shaped to diverge from the second edge, and the second edge extending along an axial direction; and (iii) a second transition region beginning at a second distance from the distal tip, the second distance being greater than the first distance, the second edge being offset from the first edge from the axial direction, the first edge in the first transition region and the second edge in the second transition region defining at least a portion of an oblique groove, at least a portion of the oblique groove traversing the tube wall and configured to receive a suture.

2. The knot pusher according to claim 1, characterized in that: The oblique groove corresponds to an opening through the tube wall, and multiple angular ends of the tube wall form a groove angle between 120 degrees and 240 degrees around the central longitudinal axis, and an angular position of the distal groove portion forms an angular interval of at least about 20 degrees with multiple ends of the oblique groove.

3. The knot pusher according to claim 1, characterized in that: A maximum depth of the bevel groove defines a baseline of the bevel groove, a base plane of the bevel groove is defined as a plane containing the baseline and parallel to the central axis, and the second edge at the beginning of the second transition area provides a suture capture protrusion, and the suture capture protrusion is located at a height X from the base plane, wherein the height X is greater than the first width.

4. The knot pusher according to claim 3, characterized in that: The height X is at least 30% of the radius of the tube wall of the tubular suture anchor.

5. The knot pusher according to claim 1, characterized in that: The distal tip of the tubular suture anchor forms an end closure that closes a majority of the inner bore, the end closure including a radial slot adjacent to the distal slot portion of the suture receiving slot, the radial slot terminating in a retaining hole having a transverse dimension greater than the first width.

6. The knot pusher according to claim 1, characterized in that: The mandrel terminates in at least one protruding finger, a cross-sectional area of ​​the protruding finger being less than half of a cross-sectional area of ​​the mandrel proximal to the protruding finger, the protruding finger being deployed such that when a suture is captured by the mandrel in the suture receiving groove, tension in the suture tends to retract the mandrel toward the retracted position, engaging the suture with the protruding finger to inhibit release of the suture and applying force to the suture to return the suture toward the distal tip.

7. The knot pusher according to claim 1, characterized in that: The knot pusher also includes an axially displaceable cutting element that is located outside or inside the tubular suture holder and is selectively displaceable in a distal direction to cut a suture exiting through a proximal end of the suture receiving channel.

8. The knot pusher according to claim 7, characterized in that: The knot pusher further includes a handle supporting the tubular suture holder, the handle having a manually operable slider device and associated spring device, the spring device including at least one spring, the manually operable slider device being configured such that an axial force applied to the slider device in a first axial direction acts on the spring device to displace the spindle from the advanced position to the retracted position, and an axial force applied to the slider device in a second axial direction opposite to the first axial direction acts on the spring device to displace the cutting element to cut a suture exiting through a proximal end of the suture receiving slot, wherein the slider device is locked against displacement in the first axial direction by a locking arrangement, and a release element of the slider device is configured such that an initial displacement of the release element in the first axial direction prior to displacement of the spindle effectively unlocks the locking arrangement.

9. A knot pusher for pushing a knot along a suture, characterized in that: The knot pusher comprises: (a) a tubular suture anchor having a tubular wall, the tubular wall defining an inner bore, the inner bore having a central longitudinal axis and terminating in a distal tip, the tubular suture anchor having a suture receiving slot, and the suture receiving slot is formed through the tubular wall and extends proximally from the distal tip, the suture receiving slot includes a distal slot portion and an oblique slot, the distal slot portion is adjacent to the distal tip and is formed with a first edge and a second edge, the first edge and the second edge are separated by a first width, the oblique slot is adjacent to and adjacent to the distal slot portion, the oblique slot has a width greater than the first width and is used to receive a suture; and (b) a mandrel axially movable within the inner bore, the mandrel biased to an advanced position in which the mandrel blocks a distal end of the suture receiving slot to slidably capture a suture entering the inner bore at the distal tip and exiting through the beveled slot, the mandrel retractable to a retracted position in which the suture receiving slot is open to receive a suture; wherein the mandrel terminates in at least one protruding finger, the protruding finger having a cross-sectional area that is less than half of a cross-sectional area of ​​the mandrel proximal to the protruding finger, the protruding finger being deployed such that when a suture is captured by the mandrel in the suture receiving groove, tension in the suture tends to retract the mandrel toward the retracted position, causing the suture to engage with the protruding finger to inhibit release of the suture and to apply force to the suture to return the suture toward the distal tip.

10. A knot pusher for pushing a knot along a suture, characterized in that: The knot pusher comprises: (a) a tubular suture anchor having a tubular wall, the tubular wall defining an inner bore, the inner bore having a central longitudinal axis and terminating at a distal tip, the tubular suture anchor having a suture receiving slot formed through the tubular wall and extending proximally from the distal tip, the suture receiving slot comprising a distal slot portion and an oblique slot, the distal slot portion being adjacent to the distal tip and forming a first edge and a second edge, the first edge and the second edge being separated by a first width, the oblique slot being adjacent to and adjacent to the distal slot portion, the oblique slot having a width greater than the first width and being configured to receive a suture; (b) a mandrel axially movable within the inner bore, the mandrel biased to an advanced position in which the mandrel blocks a distal end of the suture receiving slot to slidably capture a suture entering the inner bore at the distal tip and exiting through the beveled slot, the mandrel retractable to a retracted position in which the suture receiving slot is open to receive a suture; (c) an axially displaceable cutting element located outside or inside the tubular suture holder and selectively displaceable in a distal direction to cut a suture exiting through a proximal end of the suture-receiving channel; and (d) a handle supporting the tubular suture holder, the handle having a manually operable slider means and associated spring means, the spring means including at least one spring, the manually operable slider means being configured such that an axial force applied to the slider means in a first axial direction acts on the spring means to displace the mandrel from the advanced position to the retracted position, and an axial force applied to the slider means in a second axial direction opposite the first axial direction acts on the spring means to displace the cutting element to cut a suture exiting through a proximal end of the suture receiving slot; The slider device is locked by a locking configuration to prevent displacement along the first axial direction, and a release element of the slider device is connected to the locking configuration so that an initial displacement of the release element along the first axial direction effectively unlocks the locking configuration before the spindle is displaced.

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