WO2016168422A1 - Suture grasper and method of use thereof - Google Patents

Suture grasper and method of use thereof Download PDF

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Publication number
WO2016168422A1
WO2016168422A1 PCT/US2016/027475 US2016027475W WO2016168422A1 WO 2016168422 A1 WO2016168422 A1 WO 2016168422A1 US 2016027475 W US2016027475 W US 2016027475W WO 2016168422 A1 WO2016168422 A1 WO 2016168422A1
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WO
Grant status
Application
Patent type
Prior art keywords
rod
suture
tubular member
cut
distal end
Prior art date
Application number
PCT/US2016/027475
Other languages
French (fr)
Inventor
Richard M. Lunn
Timothy Young
Original Assignee
Smith & Nephew, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B17/06109Big needles, either gripped by hand or connectable to a handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483Hand-held instruments for holding sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06009Means for attaching suture to needle having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06042Means for attaching suture to needle located close to needle tip

Abstract

A suture grasper includes a handle, a hollow sleeve, and a rod within the sleeve, one of the hollow sleeve and the rod being fixedly attached to the handle. The rod body may include a pointed distal tip and an open-sided cut-out region adjacent the distal tip. The rod may be positioned between a retracted position, where an open side of the cut-out region is positioned within the sleeve, and an extended position, where at least a portion of the open side of the cut-out region is exposed outside the sleeve. The rod may be further placed in a position intermediate to the retracted and extended positions, where a distal end of the sleeve covers a portion of the open side of the cut-out region to form a channel through the sleeve and rod accessible through a plurality of closed-sided portals, where the channel and portals are suitable for slidably retaining a suture.

Description

SUTURE GRASPER AND METHOD OF USE THEREOF

BACKGROUND

In many surgical operations, surgeons require the ability to route sutures through or around soft tissue. A suture so routed may subsequently be used to secure damaged anatomy back to its original state. A problem arises, however, when the suture must be passed through tissue using a suture grasper that pierces the tissue, creating a defect for the suture to be routed through. With increasing size of the routing defect, the likelihood of complications due to tissue tearing also increases. Furthermore, the risk of complications becomes much higher when a patient possesses thin or minimal tissue with which to work. Existing suture graspers often employ hinged structures for suture capture. When depositing a suture, tissue is displaced and damaged during insertion into the tissue by the cross-sectional area of these suture graspers, which includes the hinged structures.

BRIEF SUMMARY

Embodiments of the disclosure are directed to a suture grasper designed to facilitate suture capture while minimizing the size of the routing defect created in the patient when depositing the suture. Advantageously, the suture grasper may forgo the use of hinged structures, resulting in a smaller cross-sectional area and reduced tissue damage during the insertion of the suture.

As discussed in greater detail below, embodiments of the suture grasper include a handle, a sleeve attached at a proximal end to the handle, and a rod positioned within a sleeve. A proximal end of the rod extends within a body of the handle and mechanically engages a trigger. A first portion of the trigger extends within the handle body, engaging the proximal end of the rod, and a second portion of the trigger is positioned outside the handle body. A user grasping the handle may actuate the rod via the trigger to make the rod extend distally with respect to the handle for suture capture, or retract proximally towards the handle for retention of a captured suture. In further embodiments, the user may position the trigger to actuate the rod to an intermediate position which allows the suture to slide freely, while still being constrained by the tip geometry. In alternative embodiments, the rod may be fixed to the handle while the sleeve is capable of moving axially with respect to the rod. In embodiments, the sleeve and/or the rod is made of a rigid material, which may be one of a metal, metal alloy, plastic or ceramic. Alternatively, the rod is made of a flexible material. In other embodiments, the proximal and distal portions of the rod are rigid while a middle portion is flexible. The flexible material may be a nickel titanium alloy (Nitinol). In embodiments, the outer diameter of the sleeve is between about 1.5 mm to about 6 mm, and the inner diameter of the sleeve is between about 1 mm and about 5 mm. In embodiments, the distance between the proximal end and the distal end of the sleeve is between about 50.8 mm and about 216 mm. In embodiments, outer diameter of the rod is between about 1 mm and about 4 mm, and a length of the rod is between about 50.8 mm and about 241 mm.

In an embodiment, the body of the rod may include a pointed distal tip and, proximally adjacent to the tip, a cut-out region and a bridge connecting the distal tip to the remainder of the rod body. The cut-out region may include an open mouth or opening that provides access to the cut-out region from outside the rod. The cut-out region may be further dimensioned for receiving a suture. For example, the cut-out region may be formed in a generally elongate or slot-like shape. In certain embodiments, the shape of the cut-out region may be circular or elliptical in shape.

In a retracted position of the rod, the cut-out region may be positioned within the sleeve, while the sharp distal tip may extend distally from the sleeve. This retracted position may be suitable for tissue piercing. In an extended position, a portion of the rod may be extended distally from the sleeve, exposing at least a portion of the cut-out region distally of the sleeve. The suture grasper maybe used to grasp a suture in the extended position. For example, the suture may be captured within the open mouth so that the suture is positioned within the cut-out region.

The rod may be further transitioned to an intermediate position between the extended and retracted positions. The cut-out region and the distal end of the sleeve are formed so as to facilitate suture retention in this intermediate position. In an embodiment, the sleeve may include one or more projections extending distally from its distal end or, alternatively, the distal end of the sleeve may have a circular rim. In an alternative embodiment, the rod may include one or more projections extending proximally from the distal end of the cut-out region. When in the intermediate position, the one or more projections block a first portion of the mouth of the cut-out region (e.g., a portion of the mouth positioned opposite the bridge). Concurrently, the projections do not block a second portion of the cut-out region, leaving the second portion of the cut-out region exposed outside the sleeve. So positioned, cut-out region forms a closed channel through the suture grasper. A suture captured within the cut-out region in the intermediate position is therefore free to slide within the closed channel of the suture grasper.

Once a suture is captured in this manner, the suture grasper may be utilized to introduce a suture to a desired location within a tissue. As a portion of the suture is secured within the suture grasper, the secured suture portion is drawn along with the suture grasper. After the suture grasper is positioned, the rod may be transitioned to the extended position to release the secured portion of the suture from the suture grasper. The suture grasper is subsequently withdrawn from the tissue, leaving the secured portion of the suture in the desired location of the tissue and limbs of the suture extending from the secured portion of suture outside of the tissue. Embodiments of the suture grasper may be further employed to capture a suture limb extending outside of the tissue and deposit that captured suture limb in another tissue location, different from the location of the originally secured portion of the suture.

In further embodiments of the suture grasper, the channel formed in the distal end inhibits significant axial displacement of a captured suture (e.g., motion in the direction of the longitudinal axis of the instrument) without applying pressure to the suture (e.g., pinching). Rather, the edges of the channel portal constrain the suture within the instrument. Suture retention in this manner may avoid damaging a grasped suture, which can otherwise occur when a suture is constrained in place by pressure. Additionally, the channel permits free sliding of a captured suture in directions transverse to the longitudinal axis of the instrument. As a result, the suture may slide through the channel when the instrument is removed from the tissue. This eliminates the need for use of additional instruments to facilitate suture sliding (e.g., looped suture retrievers). As a result, embodiments of the instrument may deposit sutures in tissue with fewer procedural steps, simplifying repair surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

Objects, features and advantages will be apparent from the following more particular description of the embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the embodiments.

Figure 1 is a schematic illustration of an embodiment of a suture grasper of the present disclosure;

Figures 2A-2B are schematic illustrations of embodiments of the suture grasper of Figure 1 in retracted and extended configurations; (A) retracted; (B) extended;

Figures 3 A-3B are schematic illustrations of embodiments of a distal tip of the suture grasper of Figure 1 in a retracted configuration suitable for piercing tissue;

Figures 3C-3D are schematic illustrations of embodiments of a distal tip of the suture grasper of Figure 1 A extended configuration suitable for grasping a suture;

Figures 3E-3F are schematic illustrations of embodiments of a distal tip of the suture grasper of Figure 1 in a position intermediate to that of Figures 3A-3D suitable for securing a grasped suture;

Figures 4A-4F are schematic illustrations of embodiments of the suture grasper of

Figure 1 in a process of grasping and securing a suture;

Figures 5A-5F are schematic illustrations of embodiments of the suture grasper of Figure 1 depositing a grasped suture in a tissue; and

Figures 6A-6C are schematic illustrations of an alternative embodiment of the suture grasper of Figure 1; (A) retracted configuration; (B) extended configuration; (C) intermediate configuration.

DETAILED DESCRIPTION

The following description of embodiments of the disclosure is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses.

The terms comprise, include, and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. And/or is open ended and includes one or more of the listed parts and combinations of the listed parts.

Embodiments of the suture grasper 100 of the disclosure will now be described with respect to the figures. As shown in Figure 1, an embodiment of the suture grasper 100 generally includes a handle 102, a tubular member 104, and a rod 106 disposed within the tubular member 104. A proximal end 104A of the tubular member 104 is attached to the handle 102 and extends distally from the handle 102 along a longitudinal axis 110. The rod 106 is positioned within the tubular member 104 and extends into the handle 102. As discussed in greater detail below, the rod 106 may be actuated by a user to slide within the tubular member 104 proximally or distally with respect to the handle 102.

In alternative embodiments of the suture grasper 100, the position of the rod 106 is fixed relative to the handle 102. That is, a proximal end of the rod 106 is attached the handle 102 and extends distally from the handle 102 along the longitudinal axis. The tubular member 104 surrounds the rod 106 and is axially-movable with respect to the rod 106. In this embodiment, tubular member 104 may be actuated by a user to slide over the rod 106 proximally or distally with respect to the handle 102.

In certain embodiments, the tubular member 104 and the rod 106 may each be independently formed from materials having sufficient mechanical properties to pierce tissue without failure (e.g., plastic deformation, crack growth, fracture, etc.). Examples of such materials may include, but are not limited to, one or more of metals, metal alloys, plastics, or ceramics. Examples of metals and metal alloys may include, but are not limited to, stainless steels, titanium, titanium alloys, cobalt-chromium alloys, platinum alloys, and palladium alloys). Examples of polymers may include, but are not limited to, polyurethanes, polyamides, fluoropolymers, polyolefins, polyimides, polyvinyl chloride (PVC) polyethylene (PE), polyethylene glycol (PEG), polystyrene (PS), polymethyl methacrylate (PMMA), polyglycolic acid (PGA), polylactic acid (PLA), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK). Examples of ceramics may include, but are not limited to, oxide-based ceramics such as aluminum oxides, calcium oxides, zirconium oxides. In certain

embodiments, the materials may be independently selected to possess one or more of shape memory and/or superelastic properties (e.g., nickel titanium alloys (Nitinol)).

The tubular member 104 and rod 106 are dimensioned to facilitate use in arthroscopic procedures. For example, the outer diameter of the tubular member 104 may be selected within the range between about 1.5 mm to about 6 mm. The inner diameter of the tubular member 104 may be selected within the range between about 1 mm to about 5 mm. The distance between the proximal end 104A and distal end 104B of the tubular member 104 may be selected between about 50.8 mm (about 2 in) and about 216 mm (about 8.5 in), alternatively between about 50.8 mm (about 2 in) and about 191 mm (about 7.5 in). In an embodiment, the outer diameter of the rod 106 may be selected within the range between about 1 mm to about 4 mm The length of the rod 106 may be selected between about 50.8 mm (about 2 in) to about 241 mm (about 9.5 in). It may be understood, however, that alternative embodiments of the suture grasper 100 may employ different dimensions than those discussed above.

With reference to Figures 2A-2B, the handle 102 includes a body 200 and a trigger 202. The handle 102 further includes an opening 204 for receiving a user's fingers, allowing a user to easily grasp the handle 102. In the embodiment shown, the handle 102 is formed in an in-line configuration, substantially co-axial with a longitudinal axis 110 of the tubular member 104. In alternative embodiments, not shown, the handle may be formed in a pistol- grip configuration. As shown in Figure 2B, the trigger 202 includes a first portion 202A and a second portion 202B. The first portion 202 A extends into the body 200 for engagement with a proximal end of the rod 106. The second portion 202B extends outside the body 200 (e.g., positioned on or adjacent an outer surface of the body 200). As illustrated in Figures 2A-2B, actuation of the trigger 202 distally causes the rod 106 to extend distally from the distal end 104B of the tubular member 104. In similar fashion, actuation of the trigger 202 proximally causes the reverse motion of the rod 106.

In alternative embodiments, where the rod 106 is fixed to the handle 102, the first portion 202A of the trigger 202 extends into the body 200 for engagement with a proximal end of the tubular member 104. Actuation of the trigger 202 causes the tubular member 104 to retract proximally, thus exposing the rod 106 from the distal end 104B of the tubular member 104. Likewise, actuation of the trigger 202 in a reverse direction causes the distal motion of the tubular member 104, covering the rod 106. It is also contemplated by this disclosure that the tubular member 104 is an independent "slide on" member that incorporates an integral, external trigger 202.

In the embodiment illustrated in Figures 2A-2B, the first portion 202A of the trigger 202 includes a plurality of holes 206. A securing mechanism (e.g., set screws, and the like) is passed through the plurality of holes 206 on each side of the first portion 202A of the trigger 202 and extends towards the longitudinal axis 110 of the suture grasper 100 to compress the proximal end of the rod 106 and hold the rod 106 in place with respect to the trigger 202, providing mechanical engagement between the trigger 202 and the proximal end of the rod 106. It may be understood that in alternative embodiments of the suture grasper 100, other mechanisms for engaging the trigger 202 with the rod 106 may be employed without limit. For example, the trigger 202 may be over-molded about the proximal end of the rod 106.

Embodiments of the tubular member 104 and the rod 106 will now be discussed in greater detail with respect to Figures 3A-3F. In the illustrated embodiments, the tubular member 104 is tube-shaped with an approximately circular cross-section. In alternative embodiments, the tubular member 104 may possess an elliptical cross-section. In further alternative embodiments, the tubular member 104 may possess a faceted, closed sided cross- section of three or more sides. The distal end 104B of the tubular member 104 further includes a sleeve body 300 enclosing a lumen 313 and having a plurality of projections 314, which may be four projections 314, distributed about its circumference, the purpose of which will be discussed in greater detail below. In alternative embodiments, however, the sleeve body 300 may only include a single projection 314.

In Figures 3A-3B, the rod 106 includes a rod body 302 and a pointed distal tip 322 positioned at a distal end of the rod body 302. In certain embodiments, the rod body 302 may adopt a cross-sectional shape matching that of the tubular member 104 to facilitate concentric sliding of the rod body 302 with respect to the tubular member 104. In alternative

embodiments, not shown, the rod body 302 and the sleeve body 300 may be further adapted to inhibit rotation with respect to one another. For example, outer surface of the rod body 302 and the inner surface of the sleeve body 300 may include one or more mating features that inhibit rotation of the rod body 302 with respect to the sleeve body 300, such as a groove extending parallel to the longitudinal axis 110 of the suture grasper 100 on one surface and a corresponding protrusion on the other surface.

As shown in Figures 3C-3D, the rod 106 further includes a cut-out region 306 formed in the rod body 302, positioned proximal to the distal tip 322. The cut-out region 306 includes a proximal end 306A and a distal end 306B, where the distal end 306B of the cut-out region 306 is positioned proximal to the distal tip 322. In the illustrated embodiment, the cutout region 306 is positioned adjacent to the distal tip 322. In alternative embodiments, the cut-out region 306 may be spaced from the distal tip 322 by a selected distance. The cut-out region 306 extends through an outer surface of the rod body 302 such that the distal tip 322 of the rod 106 is connected to the rod body 302 by a bridge 310. In particular, the cut-out region 306 extends through a plurality of surfaces of the rod body 302. In an embodiment, the cutout region 306 extends through a first surface of the rod body 302 opposite the bridge 310. In further embodiments, the cut-out region 306 further extends through a plurality of second, opposing surfaces of the rod body 302, adjacent the bridge 310. The first and second surfaces may be continuous. In further embodiments, the cut-out region 306 may be formed in a generally elongate or slot-like shape. In certain embodiments, the shape of the cut-out region 306 may be circular or elliptical in shape. For example, in an embodiment, the cut-out region 306 may be formed in a hook-like or "J" cross-sectional shape, with the base of the J-shape forming the distal end 306B of the cut-out region 306.

In the embodiment of Figures 3A-3B, the rod 106 is illustrated in a retracted position. In the retracted position, the rod body 302 is positioned within the sleeve body 300 such that the entirety of the cut-out region 306 is positioned within the sleeve body 300. In other words, the cut-out region 306 is covered by the sleeve body 300 and not accessible in the retracted position. It may be further recognized that, in the retracted position, the rod 106 is most rigidly supported by the sleeve body 300, making this position of the rod 106 suitable for piercing tissue with the distal tip 322. In the embodiment of Figures 3C-3D, the rod 106 is illustrated in an extended position, where the rod body 302 is extended distally with respect to the retracted position. The cut-out region 306 is exposed outside of the sleeve body 300, allowing access to the cut-out region 306. Accordingly, in the extended position, a suture may be positioned within the cut-out region 306. Any embodiment of the suture grasper 100 may further include a biasing member (not shown) in mechanical communication with the rod 106. The biasing member may urge the rod 106 towards one of the retracted position and the extended position.

In Figures 3E-3F, the rod 106 is illustrated in an intermediate position between the retracted position and the extended position. A first portion of the cut-out region 306 is positioned within the sleeve body 300 while a second portion of the cut-out region 306 (e.g., the distal end 306B) is exposed outside of the sleeve body 300. With the rod 106 in the intermediate position, at least one projection 314 extends over the first surface of the rod body 302 opposite the bridge 310 and blocks access to the cut-out region 306 through the first surface of the rod body 302. Concurrently, at least a portion of the cut-out region 306 extending through the second, opposing surfaces of the rod body 302 is not blocked by the distal end 104B of the tubular member 104 (including the at least one projection 314). So positioned, the distal end 306B of the cut-out region 306 and the distal end 104B of the tubular member 104, including the one or more projections 314, form a through channel 316, including portals 312 at either ends of the channel 316. Thus, a suture retained by the suture grasper 100 extends through the channel 316 and exits the suture grasper 100 through the portals 312. So positioned, the suture is constrained from exiting the channel 316 in the direction of the longitudinal axis 110 of the suture grasper 100. In alternative embodiments, the extent of proximal motion of the rod 106 may be modified such that the retracted position is unavailable. Accordingly, the user may reversibly move the rod 106 only between the intermediate position and the extended position.

In Figures 3E-3F, the shape of the distal end 306B of the cut-out region and the distal end 104B of the tubular member 104, including the projections 314, are formed so that the sides of the portals 312 are smooth (e.g., curved-sided). For example, the distal end 306B of the cut-out region 306 and the distal end 104B of the tubular member 104, including the projections 314, may be formed in semi-circular or "U" shapes having similar or identical radii of curvature. So formed, in the retracted position, the overlap of the distal end 306B of the cut-out region 306 and the distal end 104B of the tubular member 104 form portals 312 that are circular-shaped. However, it may be understood that the portals 312 may adopt any shape, as necessary. For example, in certain embodiments, the portals 312 may adopt other smooth-sided shapes, such as ovals. In further alternative embodiments, the portals 312 may instead be formed with three or more sides in the same shape or different shapes, as necessary.

While embodiments of the suture grasper 100 are discussed above in terms of a generally straight configuration, alternative embodiments of the suture grasper 100 may be curved. Examples of curves may include, but are not limited to, crescent shapes, left pigtail hooks, right pigtail hooks, different angles (e.g., between about 15° and about 70°). For example, the suture grasper 100 may include a curve or bend at a selected distance from the distal end. For example, the sleeve body 300 may be formed from a material that is sufficiently rigid to pierce tissue (e.g. steel) while capable of bending through mechanical means, and the rod 106 may be formed so as to allow the rod 106 to reversibly travel through a bend in the sleeve body 300 regardless of the relative positions in which the rod 106 and the sleeve body 300 are placed during use. In an embodiment, the rod 106 may be formed from a flexible material (e.g., Nitinol). In other embodiments, the rod 106 may be generally rigid and straight in proximal and distal sections and further include a flexible section between the proximal and distal sections. The length of such a flexible section may be greater than the length of the bent portion of the sleeve body 300.

Additionally, certain embodiments of the suture grasper 100 may include a locking mechanism (not shown) in mechanical communication with the rod 106 that inhibits motion of the rod 106 and the trigger 202 with respect to the sleeve body 300. For example, the locking mechanism may be a reversible ratchet mechanism that permits motion of the rod 106 in one axial direction and inhibits motion of the rod 106 in the opposite axial direction. The ratchet mechanism may include a gear or linear rack with teeth mounted to the rod 106 and a pawl mounted to the sleeve body 300 or the handle 102 that engages the gear or teeth. In another example, the locking mechanism may be one or more mechanical stops that fix the position of the rod 106 with respect to the sleeve body 300 at one or more selected locations (e.g., the retracted position, the extended position, intermediate positions there-between, etc.). A mechanical stop may include a retractable pin mounted to the sleeve body 300 and adapted for engagement with a socket formed in the rod 106. The pin may be moved between an engaged position, where the pin inhibits motion of the rod 106 with respect to the sleeve body 300, and a disengaged position, where the pin does not inhibit motion of the rod 106 with respect to the sleeve body 300. Alternatively or additionally, a mechanical stop may be a protrusion formed in one of the rod 106, the sleeve body 300, or the trigger 202 and a corresponding groove formed in one of the remaining ones of the rod 106, the sleeve body 300 or the trigger 202. Frictional engagement between the protrusion and groove may inhibit motion of the rod 106 and the trigger 202 with respect to the sleeve body 300, absent the application of force to displace the protrusion from the groove (e.g., a user urging the rod 106 in a desired axial direction using the trigger 202). In further embodiments, a locking mechanism that inhibits motion of the rod 106 with respect to the sleeve body 300 may be omitted from the suture grasper 100 and the rod 106 may be free to axially slide to any location within and including the extended and retracted positions. For example, a user may manually position the rod 106 and hold it in place using the trigger 202. Plastic flex features may also be incorporated into these elements to engage/disengage.

The discussion will now turn to Figures 4A-4F, which illustrate use of embodiments of the suture grasper 100 to grasp a suture 400, either inside or outside of a patient's body. In Figure 4A, the distal end of the suture grasper 100 is moved towards the suture 400 while the rod 106 is positioned in the retracted position. In Figure 4B, the rod 106 is actuated to the extended position. In Figure 4C, the suture grasper 100 is maneuvered to position a portion of the suture 400 (e.g., a bent portion 402) into the cut-out region 306. In Figures 4D-4E, the rod 106 is actuated to move to the intermediate position, with the suture 400 positioned within the channel 316. Notably, in this position, the suture 400 is constrained from exiting the channel 316. As a result, the suture 400 is captured by the suture grasper 100 and may be positioned by manipulation of the suture grasper 100 into a desired position. Beneficially, in the intermediate position, the suture 400 is free to slide within the suture grasper 100. That is to say, the suture 400 may be drawn laterally, through the portals 312, without substantial resistance.

In an alternative embodiment, shown in Figure 4F, once the suture 400 has been captured within the channel 316, the rod 106 may be proximally retracted from the intermediate position. The cross-sectional area of portal 312' in this configuration is less than portal 312 in the intermediate position and the suture 400 may be compressed between the distal end 306B of the cut-out region 306 and the distal end 104B of the sleeve body 300 (i.e., pinched). In this configuration of the suture grasper 100, the suture 400 is constrained from freely sliding within the suture grasper 100. In certain surgical techniques, the added suture stabilization provided by such a pinching constraint may be beneficial.

Figures 5A-5F illustrate placement of the suture 400 captured by the suture grasper 100 in a tissue 500. In Figure 5 A, the distal end of the instrument, containing a captured suture 400, is moved towards tissue 500. In Figure 5B, the distal tip 322 of the suture grasper 100 has pierced the tissue 500 at entry point 502 and the suture 400 is drawn through the tissue 500. In Figures 5C-5D, the rod 106 is placed in the extended position, allowing the suture 400 to be deployed from the suture grasper 100. In Figures 5E-5F, the rod 106 is placed in either the intermediate or retracted position and the suture grasper 100 is withdrawn through the tissue 500. This motion draws the suture grasper 100 out of the tissue 500, while retaining the suture 400 within the tissue 500.

Figures 6A-6C illustrate an alternative embodiment of the suture grasper 100' including tubular member 604 and rod 602 that are modified with respect to the tubular member 104 and the rod 106 discussed above. In suture grasper 100', the distal projections 314 are removed from distal end 604B of the tubular member 604 such that the distal end 604B forms a circular rim 624. The rod 602 further includes a distal tip 622 and a cut-out region 606 (Figure 6B) having proximal and distal ends 606A, 606B, respectively, where least one proximally extending projection 614 is added to a distal end 606B of cut-out region 606. For example, a projection 614 may extend along a portion of the first surface of the rod 602, opposite bridge 610. The suture grasper 100' may be otherwise unchanged from suture grasper 100, including the handle 102 and trigger 202. It should be noted that, in the embodiments described below, either one of the tubular member 104 or the rod 106 may be fixed to the handle 102, and the other of the tubular member 104 or the rod 106 may be axially movable relative thereto, as long as the tubular member 104 and the rod 106 are capable of axial movement relative to each other.

In Figure 6A, the rod 602 is illustrated in a retracted position, where the rod 602 is positioned within a lumen 613 of the sleeve body 600. So positioned, the entirety of the cutout region 606 is positioned within the sleeve body 600 and not accessible. In Figure 6B, the rod 602 is illustrated in an extended position, where the rod body 302 is extended distally with respect to the retracted position. The cut-out region 606 is exposed outside of the sleeve body 600, allowing access to the cut-out region 606. Accordingly, in the extended position, a suture may be maneuvered into the cut-out region 606.

In Figure 6C, the rod 602 is illustrated in an intermediate position between the retracted position and the extended positions of Figures 6A and 6B, respectively. A first portion of the cut-out region 606 is positioned within the sleeve body 600 while a second portion of the cut-out region 606 (e.g., the distal end 606B) is exposed outside of the sleeve body 600. With the rod 602 in the intermediate position, the at least one projection 614 extends over the first surface of the rod 602 opposite the bridge 610 and abuts the distal end 604B of the tubular member 604, blocking access to the cut-out region 606 through the first surface of the rod 602. Concurrently, the portion of the cut-out region 606 extending through the second, opposing surfaces of the rod 602 is not blocked by the distal end 604B of the tubular member 604, including the at least one projection 614. So positioned, the distal end 606B of the cut-out region 606, including the one or more projections 614, and the distal end 604B of the tubular member 604 form a through channel 616, including portals 612 at either end of the channel 616. A suture retained by the suture grasper 100 extends through the channel 616 and exits the suture grasper 100 through the portals 612. So positioned, the suture is constrained from exiting the channel 616 in the direction of the bridge 610 of the suture grasper 100' .

In another embodiment of the suture grasper 100, not shown, the cut-out region 306, 606 extends from the distal end of the suture grasper 100, rather than the side. This construction may reduce the radial area surrounding the suture grasper 100 that is needed for suture release and capture. For example, the volume needed for suture capture and passing can be estimated by the volume of a cylinder (V), given by V = π*(τ2)*1ι, where r is the radius and h is the height. Owing to the squared dependence of the volume on radius, the radius term contributes more significantly to the volume than the height. By omitting the need for side extension of the cut-out region 306, 606, the radius r, and therefore the volume of space employed for suture capture and passing, is decreased as compared to side-extending suture graspers. Suture management can therefore be carried out in tighter spaces. However, it should be noted that, in this embodiment, tissue piercing would not be possible since the distal tip 322 of the suture grasper 100 would not be pointed.

One skilled in the art will realize the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Scope of the invention is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

CLAIMS What is claimed is:
1. A suture grasper (100, 100'), comprising:
a handle (102);
a tubular member (104, 604) having a proximal end (104A, 604A), a distal end (104B, 604B) and a central lumen (113, 613) extending along the length therethrough; and
a rod (106, 602) captured within the lumen (113, 613), the rod (106, 602) including: a tip (322, 622) positioned at a distal end of the rod (106, 602); and
a cut-out region (306, 606) passing transversely through an outer surface of the rod (106, 602) proximal to the tip (322, 622);
wherein one of the rod (106, 602) and the tubular member (104, 604) is fixedly attached to the handle (102), and the other of the rod (106, 602) and the tubular member (104, 604) is axially moveable with respect thereto and adapted to slide between an extended position and a retracted position proximal to the extended position; and
wherein, at a position of the rod (106, 602) or tubular member (104, 604) intermediate to the extended and retracted positions, a distal end (306B, 606B) of the cut-out region (306, 606) and the distal end (104B, 604B) of the tubular member (104, 604) together form a channel (316, 616) that extends through the rod (106, 602).
2. The suture grasper of Claim 1, wherein the tubular member (104) further comprises at least one projection (314) extending distally from a distal end (104B) of the tubular member (104).
3. The suture grasper of Claim 1, wherein the rod (602) further comprises at least one projection (314) extending proximally from the distal end (606B) of the cut-out region (606).
4. The suture grasper of Claim 2 or 3, wherein, at the intermediate position of the rod (106, 602), the at least one projection (314) blocks access to the cut-out region (306, 606) from an upper surface of the cut-out region (306, 606).
5. The suture grasper of Claim 2 or 3, wherein, at the extended position of the rod (106, 602), the at least one projection (314) does not block at least a portion of the cut-out region (306, 606).
6. The suture grasper of Claim 1 or 3, wherein the distal end (604B) of the tubular member (604) comprises a circular rim (624).
7. The suture grasper of any one of Claims 1-6, wherein the distal end (306B, 606B) of the cut-out region (306, 606) and the distal end (104B, 604B) of the tubular member (104, 604) are approximately semi-circular when the rod (106, 602) is in the intermediate position.
8. The suture grasper of any one of Claims 1-7, wherein the tubular member (104, 604) is comprised of a rigid material.
9. The suture grasper of any one of Claims 1-8, wherein the rod (106, 606) is comprised of a rigid material.
10. The suture grasper of any one of Claims 1-8, wherein the rod (106, 606) is comprised of a flexible material.
11. The suture grasper of any one of Claims 1-8, wherein a proximal portion and a distal portion of the rod (106, 606) are comprised of a rigid material, and wherein a portion of the rod (106, 606) interposed between the proximal and distal portions of the rod (106, 606) is comprised of a flexible material.
12. The suture grasper of any one of Claims 8, 9 or 11, wherein the rigid material is selected from the group consisting of metals, metal alloys, plastics, and ceramics.
13. The suture grasper of Claim 10 or 11, wherein the flexible material is a nickel titanium alloy (Nitinol).
14. The suture grasper of any one of Claims 1-13, wherein an outer diameter of the tubular member (104, 604) is between about 1.5 mm to about 6 mm and an inner diameter of the tubular member (104, 604) is between about 1 mm and about 5 mm.
15. The suture grasper of any one of Claims 1-14, wherein a distance between the proximal end (104A, 604A) and distal end (104B, 604B) of the tubular member (104, 604) is between about 50.8 mm and about 216 mm.
16. The suture grasper of any one of Claims 1-15, wherein an outer diameter of the rod (106, 606) is between about 1 mm and about 4 mm.
17. The suture grasper of any one of Claims 1-16, wherein a length of the rod (106, 606) is between about 50.8 mm and about 241 mm.
18. The suture grasper of any one of Claims 1-17, wherein the handle (102) includes a trigger (202) for mechanical engagement with one of a proximal end of the rod (106, 602) and the proximal end (104A, 604A) of the tubular member (104, 604).
19. The suture grasper of any one of Claims 1-18, wherein, in the retracted position, the rod (106, 602) is positioned within the tubular member (104, 604) such that the entirety of the cut-out region (306, 606) is positioned within the tubular member (104, 604).
20. The suture grasper of any one of Claims 1-19, wherein, in the intermediate position, a proximal portion of the cut-out region (306, 602) is positioned within the tubular member (104, 604) and distal portion of the cut-out region (306, 602) is exposed outside of the tubular member (104, 604).
21. A method of grasping a suture, the method comprising:
moving a distal end of a suture grasper (100, 100') towards a suture (400), the suture grasper (100, 100') compri sing :
a handle (102); a tubular member (104, 604) having a proximal end (104A, 604A), a distal end (104B, 604B) and a central lumen (113, 613) extending along the length therethrough; and
a rod (106, 602) captured within the lumen (113, 613), the rod (106, 602) including: a tip (322, 622) positioned at a distal end of the rod (106, 602); and a cut-out region (306, 606) passing transversely through an outer surface of the rod (106, 602) proximal to the tip (322, 622);
wherein one of the rod (106, 602) and the tubular member (104, 604) is fixedly attached to the handle (102), and the other of the rod (106, 602) and the tubular member (104, 604) is axially moveable with respect thereto and adapted to slide between an extended position and a retracted position proximal to the extended position;
sliding the rod (106, 602) or tubular member (104, 604) from the retracted position to the extended position;
maneuvering a portion of the suture (400) into the cut-out region (306, 606); and sliding the rod (106, 602) or tubular member (104, 604) into the intermediate position wherein the suture (400) is captured within a channel (316, 616) extending through the rod (106, 602) formed by a distal end (306B, 606B) of the cut-out region (306, 606) and the distal end (104B, 604B) of the tubular member (104, 604).
22. The method of Claim 21, wherein the suture (400) is constrained from axial movement within the channel (316, 616).
23. The method of Claim 21 or Claim 22, wherein the suture (400) may be drawn laterally through the channel (316, 616) without substantial resistance.
24. The method of Claim 21, further comprising retracting the rod (106, 602) from the intermediate position, such that the suture (400) is compressed between the distal end (306B, 606B) of the cut-out region (306, 606) and the distal end (104B, 604B) of the tubular member (104, 604).
25. The method of Claim 24, wherein the suture (400) is constrained from lateral movement through the channel (316, 616).
26. A method of depositing a suture in tissue, the method comprising:
moving a distal end of a suture grasper (100, 100') towards tissue (500), the suture grasper comprising:
a handle (102);
a tubular member (104, 604) having a proximal end (104A, 604A), a distal end (104B, 604B) and a central lumen (113, 613) extending along the length therethrough; and
a rod (106, 602) captured within the lumen (113, 613), the rod (106, 602) including: a tip (322, 622) positioned at a distal end of the rod (106, 602); a cut-out region (306, 606) passing transversely through an outer surface of the rod (106, 602) proximal to the tip (322, 622); and
a suture (400) disposed in the cut-out region;
wherein one of the rod (106, 602) and the tubular member (104, 604) is fixedly attached to the handle (102), and the other of the rod (106, 602) and the tubular member (104, 604) is axially moveable with respect thereto and adapted to slide between an extended position and a retracted position proximal to the extended position;
piercing the tissue (500) with the tip (322, 622) of the rod (106, 602);
drawing the suture (400) through the tissue (500);
placing the rod (106, 602) or the tubular member (104, 604) in the extended position, allowing the suture (400) to be deployed from the suture grasper (100, 100');
placing the rod (106, 602) or tubular member (104, 604) in one of the intermediate or retracted positions; and
withdrawing the suture grasper (100, 100') through the tissue (500);
wherein the suture (400) is retained within the tissue (500).
PCT/US2016/027475 2015-04-15 2016-04-14 Suture grasper and method of use thereof WO2016168422A1 (en)

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WO2011008607A1 (en) * 2009-07-15 2011-01-20 Pivot Medical, Inc. Method and apparatus for treating a hip joint, including the provision and use of a novel suture passer
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US20060069399A1 (en) * 2003-03-18 2006-03-30 Thomas Weisel Expandable needle suture apparatus and associated handle assembly with rotational suture manipulation system
WO2011008607A1 (en) * 2009-07-15 2011-01-20 Pivot Medical, Inc. Method and apparatus for treating a hip joint, including the provision and use of a novel suture passer
WO2014043703A1 (en) * 2012-09-17 2014-03-20 Pivot Medical, Inc. Method and apparatus for passing suture through tissue
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