Surgical instruments for manipulating and threading sutures

Abstract

This invention discloses a suture threading device for manipulating and threading sutures through tissue. The device includes a handle, an elongated shaft extending from the handle, and a hook movably disposed within the elongated shaft. The elongated shaft includes a distal portion having an open end. The hook is movable from a retracted configuration to an unfolded configuration, in which at least a portion of the hook is located within the elongated shaft, and in the unfolded configuration, the hook extends distally from the open end. The hook is operatively coupled to an actuator in the handle via a connecting member, and the hook is moved from the retracted configuration to the unfolded configuration by applying tension to the connecting member.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of provisional patent application 62 / 960,477, filed on January 13, 2020, entitled “SURGICAL INSTRUMENT FORMANIPULATING AND PASSING SUTURE”, which is incorporated herein by reference in its entirety. Technical Field

[0003] This invention relates to a surgical instrument capable of manipulating and threading sutures through tissue. Background Technology

[0004] Endoscopic or arthroscopic surgery involves surgical procedures performed through small openings and under endoscopic visualization. Access to target tissues is typically provided through one or more openings created directly within the patient's body, or through the insertion of one or more cannulas into the patient via small incisions. The desired surgical procedure is then performed by the surgeon using thin instruments inserted through these cannulas.

[0005] Sutures can be passed through tissue during endoscopic surgery. They may be needed to repair tears in tissue or to connect two or more pieces of soft tissue to each other. Passing and retrieving sutures through tissue can be challenging in endoscopic or arthroscopic surgeries where visualization and space are limited.

[0006] Various endoscopic instruments have been developed for guiding and retrieving sutures through tissue. In some cases, suture retrieval can be accomplished simply by grasping the suture with ordinary tweezers. Some suture retrieval devices consist of a simple loop extending from the tip of a slender tube, which closes as the suture passes through the loop.

[0007] Direct-penetration devices have become increasingly popular, such as the Smith and Nephew ACCU-PASS sold by Smith and Nephew Inc. TMAnd at least disclosed in commonly owned and incorporated herein by reference in its entirety, U.S. Patent 10,265,062. Direct-threading devices can be used for both suture retrieval and capture without using shuttle sutures / threads. A hook-shaped suture can be selectively actuated by pushing the hook along and out of the hollow needle end. A limitation of these devices is the balance between the complexity of the actuation retrieval hook and the needle bend. Preferably, the device hook is manipulated sufficiently close to the suture or target tissue location. In endoscopic procedures where the entry point is restricted, positioning the hook so close to the suture or target location may preferably require an angular offset between the hook and the proximal end of the device. However, angular offsets, including complex bends (such as sharper bends for better alignment with tissue locations), tend to frustrate hook actuation. The pushing mechanism may not easily translate along the complex needle curve, and applying a higher load may cause the suture to buckle.

[0008] Therefore, there is a need for a suturing instrument that overcomes the above-mentioned drawbacks and manipulates sutures through tissues using a more complex needle bend. Attached Figure Description

[0009] For a detailed description of the exemplary embodiments, reference will now be made to the accompanying drawings, in which:

[0010] Figure 1A and 1B An exemplary end of a needle with a sharp bend or a complex bend is shown;

[0011] Figure 2 An exemplary suture threader according to at least some embodiments is shown;

[0012] Figure 3A and 3B A flexible ring construction for a suture capturing member for an actuating suture threader is shown according to at least some embodiments;

[0013] Figure 4 A cross-section of a suture threader handle having a closed-loop pulley construction is shown according to at least some embodiments;

[0014] Figure 5A and 5B A method for unfolding and retracting a suture thread catcher according to at least some embodiments is shown; and

[0015] Figure 6A and 6B An embodiment of a tension biasing device having an operative connection to a flexible ring construction is shown, according to at least some embodiments. Summary of the Invention

[0016] Various terms are used to refer to specific system components. Different companies may use different names to refer to a component—this document is not intended to distinguish between components with different names but the same function. In the following discussion and claims, the terms "comprising" and "including" are used in an open-ended manner and should therefore be interpreted as "including but not limited to...". Furthermore, the terms "connected" or "coupled" are intended to indicate indirect or direct connection. Thus, if a first device is connected to a second device, the connection can be either a direct connection or an indirect connection via other devices and connections.

[0017] Generally, a device for selectively capturing and releasing surgical elements such as sutures is disclosed. The device includes a needle tip for accessing a target location, the needle preferably including a tissue-penetrating tip. The needle is hollow and houses a capturing member within it. Once in the desired position, the capturing member slides and protrudes from the needle tip to capture the surgical element. Throughout this disclosure, the capturing member is shown as a hook; however, other embodiments may include a shaped thread, or multiple curved threads or hooks, generally configured to protrude from the needle tip and capture or wrap around the surgical element to move the element to different locations. This different location may include through the thickness of tissue.

[0018] In some embodiments, the needle may have at least one bend along it to improve proximity to a target location. In some embodiments, the at least one bend may include a complex curve defined as at least one bend having at least 60 degrees along at least one plane. In other words, the needle may include at least one bend that angularly offsets the longitudinal axis of the distal end of the needle relative to the longitudinal axis of the proximal portion of the needle, the angular offset extending through the distal end of the device by at least 60 degrees. In some instances, the complex curve may include at least two consecutive curves, such as an S-curve. In other instances, the complex curve may define a curve in three-dimensional space, such as a spiral curve. Exemplary needle curves 10A and 10B are respectively in Figure 1A and 1B As shown in the image. Figure 1A A single curve with an angle greater than 60 degrees is shown. More precisely, Figure 1A A single curve exceeding 90 degrees and approximately 120 degrees is shown. Figure 1BA spiral curve 10B is shown. In a needle extending along a complex curve as described herein, using a pusher to deploy a sliding capture member can be frustrating. A pusher rigid enough to transmit a push (compressive load) may not be suitable for easily bending around complex geometric curves or sharp bends. This disclosure includes flexible constructions, such as those formed from flexible cables, threads, ropes, or stitches, that can extend around and slide along the complex geometry of the needle. In some embodiments, the needle may have a first bend or be straight and may be malleable, allowing a user to selectively adjust the needle bend. The flexible constructions described herein are configured to accommodate a range of bends adjustable due to a malleable instrument or instrument shaft; malleability is defined as a malleable deformable portion of the shaft such that when the shaft is bent, it retains the bend shape upon release of the force applied from the user. In other embodiments, the needle may include a flexible portion that can be controllably hinged to selectively hinge to the bend construction. For example, an exemplary flexible portion may include a tubular spring or a series of axially spaced slots defining ridges.

[0019] The handle end of the device can be operably coupled to a flexible structure to apply tension and move the flexible structure in a desired direction. One side of the flexible structure can be under tension to deploy the capture member, and the other side of the flexible structure can be under tension to retract the capture member.

[0020] The following discussion relates to various embodiments of the invention. While one or more of these embodiments may be preferred, the disclosed embodiments should not be construed as or otherwise used to limit the scope of this disclosure, including the claims. Furthermore, those skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is intended only as an example of that embodiment and is not intended to imply that the scope of this disclosure, including the claims, is limited to that embodiment.

[0021] Various embodiments relate to a suture threading device for manipulating and threading sutures through tissue. The device includes a handle and an elongated shaft extending from the handle. The shaft has a distal portion with an opening. The device also includes a hook movable from a retracted configuration to an unfolded configuration, in which at least a portion of the hook is located within the shaft, and in the unfolded configuration, the hook extends out of the shaft and through the opening. The device further includes a connecting member operatively coupled to both the hook and the actuator of the handle. Tension on the connecting member moves the hook from the retracted configuration to the unfolded configuration.

[0022] In some example embodiments, the distal axial portion may define a needle with a distal tip that penetrates tissue. A connecting member may be slidably located within the elongated distal axial portion and has a distal end disposed within the distal axial portion. The connecting member may define a flexible ring configuration. The flexible ring configuration may surround a rod that extends across and within the distal axial portion. Tension on a first side of the flexible ring configuration is configured as an unfolding hook, and tension on a second side of the flexible ring is configured as a retracting hook. The elongated distal axial portion defines an axis that may define a complex curve, and the connecting member may extend along the complex curve. The connecting member may extend along the entire complex curve in both the unfolding and retracting configurations. The connecting member may be coupled to the shank via a biasing member configured to maintain minimal tension on the connecting member.

[0023] An exemplary method of manipulating a suture is disclosed, comprising the step of placing the open end of an elongated shaft of a suture threader near a target suture. Tension is applied to a connecting member disposed along the elongated shaft to unfold an inner member from the open end. The suture is engaged by the inner member. In some exemplary methods, the elongated shaft defines an axis having a complex curve configured to position the inner member adjacent to the target suture at a location angularly offset from the proximal longitudinal axis of the elongated shaft. In some exemplary methods, the connecting member extends around the complex curve, and the inner member is engaged to the connecting member distal to the complex curve. The connecting member may be a flexible member loop having a first side and a second side of the loop. Applying tension to the connecting member to unfold the inner member may include applying tension to the first side. Applying tension to the second side may retract the inner member back into the shaft. The method may also include piercing tissue with a sharp distal tip of the elongated shaft. The method may further include adjusting the angular offset between the open end and the proximal axis of the instrument before engaging the suture with the inner member. The elongated shaft may be deformable to change the angular offset.

[0024] Another exemplary embodiment of a suture threader is disclosed, comprising a shank having an actuator and an elongated shaft extending distally from the shank. The elongated shaft includes a distal end having an opening. The suture threader also includes a capturing member slidably disposed along the shaft and extending through the opening. The suture threader further includes a connecting member slidably located within the shaft and operatively coupled to both the capturing member and the actuator. The connecting member moves the capturing member between a retracted position, in which the capturing member is received within the shaft, and in an extended position, the capturing member extends from the opening. One side of the connecting member slides proximally while moving the capturing member to the extended position.

[0025] In some example embodiments, a distal end defines an axis having a complex curve along its distal end, and a connecting member extends around this complex curve. The connecting member may define a flexible ring configuration extending along the axis, the distal end of which is spaced proximally from an opening in the axis. The connecting member may surround a first rod and a second rod, the first rod being proximally spaced and fixedly spaced from the opening, and the second rod being fixedly disposed adjacent to the actuator. Tension on the other side of the connecting member can retract the capturing member. Detailed Implementation

[0026] Various embodiments relate to apparatus and methods for translating a hook along the complex curve of a suture threader. The specification now turns to exemplary systems.

[0027] The foregoing discussion is intended to illustrate the principles and various embodiments of the invention. Many variations and modifications will become apparent to those skilled in the art once the foregoing disclosure is fully understood. The following claims are intended to be construed as including all such variations and modifications.

[0028] Figure 2 A surgical instrument 100 for manipulating and threading sutures is shown. Instrument 100 includes a handle 1, a lever, a slider or button 2, an elongated shaft 3, and a working end 4. The working end 4 may define a distal end that penetrates tissue, which is hollow and houses a hook or capture member therein. As described herein, the slider 2 controls the position of the hook relative to the working end 4. The working end 4 may include at least one sharp bend (greater than 60 degrees) or a complex curve as defined herein. The working end 4 is capable of being bent to form a complex curve via input from the user. A flexible structure 5 may be disposed within the working end 4 and along the elongated shaft. The flexible structure 5 can selectively deploy the capture member (hook) from an opening 6. Instrument 100 can be used for threading and / or retrieving sutures in a wide variety of applications, including labrum or rotator cuff repairs.

[0029] Figure 3A and 3BA flexible configuration 5 for deploying a capture member from within a needle cavity is shown, the needle having a complex bend as defined herein. Configuration 5 relies on a flexible member 250, which may be, for example, a rope, cable, thread, or stitch that can be in a continuous loop. The flexible configuration 5 extends and moves readily along the complex curve. Configuration 5 advances and retracts the capture member 270 by applying tension to the flexible configuration 5, thus avoiding the frustration associated with pushing an actuating member around the complex curve. A slider or button 2 may be operably coupled to the flexible member 250 at point 210. The slider or button 2 may be a wheel, a slide, or any other device for applying tension to the flexible member 250. The slider or button 2 may slide in a first direction to advance the capture member 270 and in the opposite direction to retract the capture member. For example, the slider 2 may move in a proximal direction along the longitudinal axis of the device to advance the capture member 270. The slider 2 may move in a distal direction along the longitudinal axis of the device to retract the capture member 270. Alternatively, the slider 2 can be operatively coupled to a biasing member (not shown) such that release of the slider 2 automatically moves the slider 2 to retract the capturing member 270. The configuration 5 may also include two pulley rods 255a and 255b, and the flexible member 250 may form a continuous loop around the two rods 255a and 255b. The flexible member 250 is movable around the two rods 255a and 255b. The proximal rod 255a may be disposed within the handle 1. The distal rod 255b may be disposed along the working end 4 and may be adjacent to the opening 6. The distal rod 255b may extend across the inner diameter of the working end 4. The capturing member 270 is operatively coupled to the flexible member 250 at the working end 4. The capturing member may be formed separately from the flexible member 250 and coupled to the flexible member 250 via a coupling means (e.g., fastening, adhesive, or welding). The capturing member 270 may preferably be more rigid than the flexible member 250. For example, the capture member can be a biocompatible metal, such as stainless steel. The flexible ring component 250 can form a ring and extend around the proximal rod 255a and the distal rod 255b, forming a pulley configuration. Pushing or pulling the actuator 2 slides the flexible component 250 along the shaft 3 and the working end 4, which translates the capture member 270 into and out of the opening 6. Two rods 255a and 255b are shown here. Depending on the curve geometry, additional rods may be required along the curve.

[0030] The capturing member 270 can be in the form of a hook to retrieve, manipulate, and release a length of suture during surgery. The capturing member 270 is preferably rigid to better aim at itself and resist deformation when the captured suture is pulled and manipulated. Therefore, the entire length of the capturing member 270 can be configured to be fully accommodated within the needle tip in a stress-free or low-stress configuration. In a retractable configuration, the entire length of the capturing member 270 can be positioned within the working end and along the working end, between the opening 6 and the furthest lateral bend 12. This allows the capturing member 270 to have greater stiffness to deformation, while the flexible configuration 5 provides a mechanism for translating the device (unfolding and retracting) along complex curves. The concept of this mechanism is... Figure 3A The diagram is shown on the working end 4 with a single bend, where α passes through the distal end at an angle of approximately 60 degrees. However, the same mechanism can be used for more extremely complex working end curves, such as... Figure 3B , 1A And the example shown in 1B. Figure 3B It shows a ratio Figure 3A An exemplary embodiment of the more abrupt curve 12, wherein the capturing member 270 has a length H, the capturing member 270 is in a retracted configuration, and is thus positioned between the open end 6 and the furthest bend 12. In some embodiments, the shaft 3 may be malleable or alternatively steerable, such that the bend 12 may be variable.

[0031] Preferably, the flexible structure 5 extends along the complex curve of the working end 4, while the more rigid suture capturing member 270 remains relatively neutral (stress-free or flexural). Therefore, the flexible structure 5 extends along a larger portion of the complex curve of the working end. The most distal end of the flexible structure 5 is defined by the bar 255b, and thus the bar 255b is preferably positioned adjacent to the opening 6. The bar 255b may preferably be positioned at the most distal lateral bend 12, and more preferably along the working end 4 on one side of the most distal lateral bend 12 opposite to the handle 1. Thus, the flexible structure 5 as a whole remains axially stationary relative to the axis, because the bars 255a and 255b may not move when the capturing member 270 moves into and out of the needle tip. Although the flexible member 250 can slide axially along the axis, its position is limited within the axis by the position of the bar 255. In other words, the flexible structure 5 does not move into and out of the needle tip when the suture capturing member 270 unfolds and retracts.

[0032] refer to Figure 5A and 5B of Figure 4 A cross-section of the handle 1 is shown. The sliding actuator 2 is shown operatively coupled to the flexible structure 5. The flexible structure 5 includes a first or retracted side 5a and a second or extended side 5b. Figure 5A and 5BThe diagram illustrates a method of capturing a suture using a suture threader 100. To deploy (advance) the capturing member 270, a button or slider 2 can be pulled proximally from the retractable configuration. This applies tension to the first side 5a and slides the suture capturing member 270 out of the opening 6 at the working end 4. Depending on the geometry of the curve on the working end 4, the capturing member 270 can extend distally. For example... Figure 3B The complex curve shown allows the capturing member 270 to extend along the needle at an angle defined by curve 12. For example, if the complex curve orients the farthest end of the working end 4 at a 120-degree angle relative to the longitudinal axis of the proximal end of the shaft 3 through the far end, as... Figure 3B As shown, the stitch-catching member 270 can extend along approximately the same angle. Continuing this example, the catching member 270 can thus extend toward the handle and therefore in a direction defined by a complex curve in the proximal direction.

[0033] To retract the capture member 270 from the unfolded configuration, the button or slider 2 can be pushed distally to apply tension to the second side 5b and retract the capture member 270 back into the working end. Depending on the geometry of the curve on the working end 4, the capture member 270 can be pulled proximally. However, in Figure 1A In the geometry shown, the stitch-catching member 270 can be pulled into the working end 4 in a generally distal direction. In an alternative embodiment, the button or slider 2 can be attached to the other side of the ring, and thus pushing the slider 2 distally can apply tension to the first side 5a.

[0034] Figure 6AAn additional tension spring 280 is shown connecting the handle 2 and the rod 255a. In some embodiments, the rod 255a may therefore not be fixedly attached to the handle 2, but rather attached via the spring 280, and thus be movable to a limited extent. The rod 255a may be constrained to move only in a single direction. For example, the rod 255a may be constrained to move only axially using a groove or surface 256 associated with the handle 2, such that the rod 255a may translate only along a single (axial) direction. The spring 280 may be configured to compensate for any tension transfer on the flexible structure 5 during manipulation 100. For example, in some embodiments, the shaft 3 may be malleable and may be selectively bent to a target orientation by a surgeon. The tension on the flexible structure 5 may change during bending. In some embodiments, the shaft 3 may flex during tissue manipulation, and thus change the tension on the flexible structure 5. Additionally, the tension on the flexible structure 5 may relax over time during packaging or use. Alternative means of compensating for any transfer of tension on the flexible structure 5 may include a cantilever 290. A cantilever 290 can be connected between the handle 2 and the rod 255a. Similar to the embodiment with spring 280, the rod 255a can therefore not be directly attached to the handle 2, but rather via the cantilever 290. The rod 255a can be constrained to axial movement only using a slot or surface 256 associated with the handle 2, allowing the rod 255a to translate only in a single (axial) direction. The cantilever 290 can be configured to compensate for any tension transfer on the flexible structure 250 during actuation 100, similar to those described in conjunction with spring 280. The cantilever 290 or spring 280 can provide a means of maintaining a desired distance between the two rods (255a and 255b), configured to maintain minimum tension on the flexible structure. Without maintaining minimum tension on the flexible structure, axial translation of the first or second side of the flexible structure may not directly translate the position of the capturing member.

[0035] This document also discloses a method for capturing surgical elements such as sutures, comprising placing the open needle end 6 of an elongated shaft of a suture threader 100 near a target location, and then applying tension to a flexible structure 5 disposed along the elongated shaft to unfold a capturing member 270 from the open end 6. Tension to a first side of the flexible structure can retract the first side of the flexible structure 5 and unfold the capturing member 270. The element can then be captured by the capturing member 270. Capturing may include applying tension to a second side of the flexible structure 5 (different from the first side), and the second side of the flexible structure 5 can be retracted, and the capturing member 270 having the capturing element therein can be retracted. The method may further include deforming the elongated shaft to form a bend along the elongated shaft. The method may further include hinged the elongated shaft to position the open end 6 closer to the target tissue. The flexible structure 5 may be operatively coupled to a shank actuator of the suture threader, and applying tension to the flexible structure may include actuating the actuator. The method may further include piercing the tissue with the sharp distal tip of the elongated shaft. The flexible structure 5 can define a closed-loop structure that extends along an elongated axis and is operatively coupled to the actuator, and the method can further include applying tension to a first side of the closed-loop structure to retract the first side and deploy the capture member, and applying tension to a second side of the closed loop to retract the second side and thereby retract the capture member back into the open end.

[0036] Although only a few embodiments of the invention have been described, it should be understood that the invention may be implemented in many other specific forms without departing from the spirit or scope thereof. Therefore, these embodiments should be considered illustrative rather than restrictive, and the invention is not limited to the details given herein, but may be modified within the scope of the appended claims.

Claims

1. A suture threading device, comprising: The handle at the proximal end of the device has an actuator; An elongated shaft extending from the shank, the elongated shaft including a distal portion having an opening; A hook, which is movable from a retracted configuration to an extended configuration, wherein at least a portion of the hook is located within the elongated shaft, and wherein the hook extends through the opening and extends to the outside of the elongated shaft in the extended configuration; as well as A connecting member operably connected to both the hook and the actuator, the connecting member being configured such that tension on the connecting member in the proximal direction causes the hook to move from the retracted configuration to the deployed configuration. The connecting member defines a flexible ring structure that surrounds a rod that extends across the distal portion of the elongated shaft. Tension along the proximal direction on a first side of the flexible ring structure unfolds the hook, and tension along the proximal direction on a second side of the flexible ring retracts the hook.

2. The suture threading device of claim 1, wherein the distal portion of the elongated shaft defines a needle, the needle having a distal tip capable of penetrating tissue.

3. The suture threading device according to claim 1, wherein the connecting member is slidably located within the elongated shaft, wherein, The farthest end of the connecting member is located within the slender shaft.

4. The suture threading device of claim 1, wherein the distal portion of the elongated shaft defines an axis, the axis defines a complex curve, and the connecting member extends along the complex curve.

5. The suture threading device of claim 1, wherein the connecting member is further connected to the handle by a biasing member configured to maintain minimum tension on the connecting member.

6. A suture threader, comprising: A handle having an actuator; An elongated shaft extending from the shank, the elongated shaft having a longitudinal axis extending through the elongated shaft to a distal end having an opening; A suture-catching member, slidably disposed along the elongated axis and extending through the opening. A connecting member, which is slidably located within the elongated shaft and operably connected to both the suture capturing member and the actuator; The connecting member is configured to move the suture capturing member along the longitudinal axis between a retracted position and an extended position, wherein in the retracted position the suture capturing member is received within the elongated shaft, and in the extended position the suture capturing member extends from the opening, and wherein, when the suture capturing member is moved to the extended position, one side of the connecting member slides proximally along the longitudinal axis. The connecting member defines a flexible ring structure that surrounds a rod that extends across the distal portion of the elongated shaft. Tension along the proximal direction on a first side of the flexible ring structure unfolds the suture capturing member, and tension along the proximal direction on a second side of the flexible ring retracts the suture capturing member.

7. The suture threader of claim 6, wherein the distal end of the elongated shaft defines an axis having a complex curve along the distal end of the shaft, and wherein the connecting member extends along the complex curve.

8. The suture threader according to claim 6, wherein, The farthest end of the flexible ring structure is spaced from the opening of the slender shaft towards the proximal side around the stationary rod.

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