Patent Description:
Medical devices, such as suture anchors, have been developed for attaching soft tissue to bone. A suture anchor is typically inserted into and fixed within a bone hole drilled into bone at a surgical repair site. Sutures are typically coupled to the anchor and are used to secure the soft tissue to the bone to effect the repair. For many repair procedures, accuracy in the placement of suture anchors in bone is required to achieve consistently positive surgical outcomes, requiring substantial skill on the part of the surgeon.

Accurate placement of bone holes and suture anchors can be particularly challenging when repair is performed arthroscopically, as both access to and visibility of an arthroscopic surgical site may be more limited than is the case with open surgical procedures. For example, accurately drilling bone holes and placing suture anchors into these holes, at certain joint areas of the body, can be difficult for even a very experienced surgeon. This is due to the inability of the delivery devices to reach a preferred anchor delivery point or a preferred anchor trajectory, or both. One solution has been to provide curved drill guides to access locations and trajectories that would be difficult or impossible to access using straight in-line instruments. Most existing curved drill guides have cannulated shafts with varying degrees of curvature to guide passing instruments along a desired path. However, use of curved drill guides also necessitates the use of auxiliary curved instrumentation, such as a drill, an obturator, and/or an anchor inserter. <CIT> relates to a system for implanting an anchor into the bone.

Disclosed herein is an anchor delivery system which includes both a straight and curved drill guide along with a flexible drill, a flexible obturator and a flexible anchor inserter. The curved drill guide has a distal tip with approximately a <NUM>° bend from the primary axis of the drill guide. Both the drill and the obturator have a reduced diameter section to improve flexibility during passage through the curved drill guide. Additionally, a surface of the inserter shaft has a laser cut pattern which permits flexing of the inserter around the inner diameter of the curved drill guide. Each of these adaptations advantageously allows the instruments to be used with both the straight and curved guides to achieve a wider range of access and trajectories during arthroscopic procedures.

Further examples of the anchor delivery system of this disclosure may include one or more of the following, in any suitable combination.

Examples of the anchor delivery system of this disclosure include a guide for insertion into a repair site, the guide having a central passage extending therethrough. A distal portion of the guide is curved relative to a longitudinal axis of the guide. The system also includes an obturator insertable through the passage of the guide for blocking the passage during insertion of the guide into the repair site. The obturator includes a shaft having a flexible portion. A diameter of the flexible portion is selected to allow bending of the obturator so as to pass through the curve of the guide. The system further includes a drill insertable through the passage of the guide for forming a hole in a bone at the repair site. The drill including a shank having a flexible portion. A diameter of the flexible portion is selected to allow bending of the drill so as to pass through the curve of the guide. The system also includes an anchor delivery tool insertable through the passage of the guide for implanting an anchor into the hole. The anchor delivery tool includes an elongate member having a flexible portion. A surface of the flexible portion includes a plurality of cuts permitting flexing of the anchor delivery tool about the cuts so as to pass through the curve of the guide. The elongate member comprises a tapered region between its distal portion and its proximal portion, the distal portion comprising an area of reduced diameter relative to the proximal portion.

In further examples of the system, a tip of the guide is configured to stabilize the guide against the bone. The distal portion of the guide includes at least one aperture in the surface of the guide in communication with the central passage of the guide. In examples, an angle of the curve is about <NUM> degrees. The diameter of the flexible portion of the shaft of the obturator is selected to be smaller than a diameter of a non-flexible portion of the shaft. In examples, the obturator includes a conical, atraumatic tip. The diameter of the flexible portion of the shank of the drill is selected to be smaller than a diameter of a non-flexible portion of the shank. In examples, the shank of the drill comprises Nitinol. In examples, the flexible portion of the shank of the drill includes a series of necked-down regions for increasing flexibility of the flexible portion. In other examples, the flexible portion of the shank of the drill includes a series of lobes for providing a bearing surface and a reduced clearance space between the drill and the guide. The series of lobes are adjacent to a cutting portion formed on or attached to a distal end of the drill. In examples, a distal end the elongate member of the anchor delivery tool comprises an area of reduced diameter. In examples, the system further includes an anchor coupled to the anchor delivery tool via a suture routed through a channel of the delivery tool and through a transverse eyelet of the anchor.

Examples of a method of delivering an anchor to a repair site of this disclosure, which do not form part of the invention, include passing an obturator through a passage of a guide, the obturator including a shaft having a flexible portion. A diameter of the flexible portion is selected to allow bending of the obturator so as to pass through a curve of the guide. The method also includes passing the obturator and the guide over a guide wire implanted in a bone, and placing the tip of the guide against the bone to stabilize the guide. The method further includes removing the obturator from the passage of the guide and inserting a drill through the passage of the guide to drill a hole in the bone. The drill includes a shank having a flexible portion. A diameter of the flexible portion is selected to allow bending of the drill so as to pass through the curve of the guide. The method also includes removing the drill from the passage of the guide and passing an anchor coupled to an anchor delivery tool through the passage of the guide. The anchor delivery tool includes an elongate member having a flexible portion. A surface of the flexible portion includes a plurality of cuts permitting flexing of the anchor delivery tool about the cuts so as to pass through the curve of the guide. Examples of the method also include inserting the anchor into the hole in the bone, implanting the guide wire in the bone, removing the anchor delivery tool from the passage of the guide.

Examples of an anchor delivery tool of this disclosure include an elongate member having a flexible portion. A surface of the flexible portion includes a plurality of cuts permitting flexing of the tool about the cuts so as to pass through a curve of the guide. In examples, a distal end the elongate member comprises an area of reduced diameter. Examples of the anchor delivery tool further include an anchor coupled to the tool via a suture routed through a channel of the tool and through a transverse eyelet of the anchor.

Examples of a drill apparatus of this disclosure include a drill shaft having a proximal end and distal end. The drill apparatus also includes a cutting portion formed on or attached to the distal end of the drill shaft. The drill apparatus also includes a plurality of lobes formed on the drill shaft adjacent to the cutting portion. An outer circumferential surface of each lobe has a bearing surface. The drill apparatus also includes a plurality of neck segments. Each of the neck segments is located between adjacent instances of the lobes and have a lesser diameter than the plurality of lobes.

In further examples of the drill apparatus, the proximal end of the drill shaft is configured for coupling to a drill. In examples, the drill shaft is made from nitinol. In examples, the drill shaft extends through the curved drill guide. In examples, the curved drill guide includes a handle and a guide shaft coupled to the handle. The guide shaft includes a distal portion angled relative to a longitudinal axis of the guide shaft. The distal portion includes an end having a serrated edge. In examples, the drill shaft further includes a counterbore positioned distally to the plurality of lobes. The counterbore defines a plurality of cutting elements. In examples, each of the plurality of cutting elements has a cutting angle of between about <NUM>-<NUM>°.

The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:.

In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.

As used in the specification and claims, for the purposes of describing and defining the invention, the terms "about" and "substantially" are used represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. "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.

Referring now to <FIG>, an exemplary anchor delivery system <NUM> of the present disclosure is illustrated. As shown in <FIG>, the anchor delivery system <NUM> may include a curved guide <NUM> and a straight guide <NUM>. A bend or curve is incorporated into curved guide <NUM> to direct passing instruments around anatomy during surgery, especially anatomy that prevents a straight trajectory. An anchor delivery tool <NUM> may also be provided which has a flexible shaft portion 42b. The anchor delivery tool <NUM> is capable of delivering an anchor <NUM>, which may be a soft suture anchor, into a bone hole in a repair site of a patient. A flexible obturator <NUM> may also be provided and may be used for insertion through a passage extending through each of the guides <NUM> and <NUM>. Finally, a flexible drill <NUM> may further be provided. A cutting portion <NUM> of the drill <NUM> may be capable of drilling a hole in bone for insertion of the anchor <NUM>, as further described below.

<FIG> and <FIG> illustrate in further detail the curved guide <NUM> and the straight guide <NUM> of the present disclosure. Both of the guides <NUM>, <NUM> may comprise a high-strength material, such as stainless steel, in order to substantially reduce the possibility of plastic deformation of the guides <NUM>, <NUM> when subjected to various bending forces during surgery. However, other high-strength material known to one of ordinary skill in the art can be used. As shown in <FIG>, the guides <NUM>, <NUM> each include a shaft <NUM> coupled to a handle <NUM>. A central passage <NUM> (<FIG>) extends through the shaft <NUM> and the handle <NUM> for receiving the drill <NUM>, the obturator <NUM> and the anchor delivery tool <NUM> of <FIG>. The shaft <NUM> further includes a proximal portion 24a and a distal portion 24b. The proximal portion 24a is coupled to the handle <NUM> and extends distally from the handle <NUM>. In examples, the handle <NUM> is slightly tapered toward the shaft <NUM> and includes ribs <NUM> along a length of the handle <NUM> for maintaining a grip on the handle <NUM> while imparting axial compression and bending into the guides <NUM>, <NUM> during surgery. However, other means for maintaining a grip, known to one of ordinary skill in the art, may be used.

In <FIG>, it can be seen that the distal portion 24b of the shaft <NUM> includes an area of reduced diameter <NUM> terminating in a tip <NUM> configured for stabilizing the guide <NUM>, <NUM> against bone. The distal portion 24b may also include at least one open side window <NUM>. For the purposes of this disclosure, there are two windows <NUM> formed on opposite sides of the shaft <NUM>. However, there may be more or fewer than two windows <NUM>. The windows <NUM> may be useful for viewing depth markings on a surface of the passing instruments shown in <FIG>. In examples, the windows <NUM> are located as distally as possible along the shaft <NUM>, since the space to view them arthroscopically is small in some joints (such as the hip). In other examples, the windows <NUM> may be located more or less distally along the shaft <NUM>. As seen in <FIG>, the distal portion 24b of the curved guide <NUM> is bent or curved relative to the longitudinal axis A of the curved guide <NUM>. In examples, the angle of the bend or curve is about <NUM>°.

<FIG> show examples of the tip <NUM> of the guide <NUM>, <NUM> (shown as straight guide <NUM> for illustrative purposes). Specifically, the distal portion 24b of the guide <NUM>, <NUM> as shown in <FIG> includes a forked tip <NUM> and an open side window <NUM> in communication with the central passage <NUM> of the guide <NUM>, <NUM>. Similarly, the guide <NUM>, <NUM> as shown in <FIG> includes a crown-shaped tip <NUM> and open side windows <NUM>. Other convenient shapes may be used for the tip <NUM> of the distal portion 24b of the shaft <NUM>, the shape being selected to help stabilize the guide <NUM>, <NUM> against bone.

<FIG> illustrates examples of the anchor delivery tool <NUM> and the anchor <NUM> of the present disclosure. The anchor delivery tool <NUM> includes a shaft <NUM> and a handle (<FIG>) coupled to the shaft <NUM>. In examples, the shaft <NUM> and the handle may be assembled by heat staking, ultrasonic staking, spin welding, insert molding, or other methods known to one of ordinary skill in the art. The shaft <NUM> comprises stainless steel, but may be made from another biocompatible material known to one of ordinary skill in the art. Also, for the purposes of this disclosure, the handle may include suture retaining features for retaining a repair suture <NUM>.

The shaft <NUM> includes a proximal portion 42a and a tapered-down distal portion 42b. The distal portion 42b comprises an area of reduced diameter <NUM> which is used for depth stop and relief purposes, as will be further described below. A surface of the proximal portion 42a further comprises a laser cut pattern <NUM> which permits flexing of the proximal portion 42a around the curve of the curved guide <NUM>. As shown in <FIG>, the anchor <NUM> is disposed on a proximally-extending boss <NUM>. The repair suture <NUM> extends through a cannulation of the shaft <NUM> and through opposing slots <NUM> in the distal portion 42b of the shaft <NUM>. The repair suture <NUM> is also routed through a transverse eyelet <NUM> of the suture anchor <NUM>. When the repair suture <NUM> is pulled proximally by the handle, the boss <NUM> is pulled inside the distal portion 42b of the shaft <NUM> such that the anchor <NUM> abuts the distal end of the distal portion 42b and is coupled to the delivery tool <NUM>, as shown in <FIG>.

<FIG> illustrates an exemplary obturator <NUM> that allows for easier percutaneous introduction of the guide <NUM>, <NUM> to a desired site within the body by filling the inner diameter of the central passage <NUM> of the guide <NUM>, <NUM> and substantially reducing the possibility of the tip <NUM> of the guide <NUM>, <NUM> becoming caught on tissue within the body. The obturator <NUM> includes a shaft <NUM> coupled to a handle (<FIG>). In examples, the shaft <NUM> and the handle of the obturator <NUM> are made from stainless steel and plastic, respectively. However, either one could be made from any other biocompatible material known to one of ordinary skill in the art. The shaft <NUM> may be cannulated for passing over a guide wire, as further described below. The shaft <NUM> includes a proximal portion 62a and a tapered-down distal portion 62b. A diameter of the distal portion 62b is selected to be smaller than a diameter of the proximal portion 62a to improve flexibility during insertion into the curved guide <NUM>. Specifically, the distal portion 62b allows the shaft <NUM> to bend along the angled distal portion 24b of the curved guide <NUM> when the shaft <NUM> is inserted through the guide <NUM>. The distal portion 62b of the obturator <NUM> may include a conical, atraumatic tip <NUM> for easier passage of the obturator <NUM> through the body. In other examples, not shown, the obturator <NUM> may have a sharp tip <NUM> allowing for easier and quicker insertion of the guide <NUM>, <NUM> into the body.

<FIG> shows an exemplary drill <NUM> for drilling a bone hole in bone. In an illustrative example of the drill <NUM>, a low friction bearing surface may be provided by a shoulder portion 82a of a drill shaft <NUM>. The shoulder portion 82a provides reduced clearance between the shaft <NUM> and the drill guide <NUM>, <NUM> in which it is installed to maintain centering of the drill shaft <NUM> with respect to the inside diameter of the drill guide <NUM>, <NUM>. A necked down portion 82b of the shaft <NUM> provides flexibility that allows the shaft <NUM> to extend through bends in a curved drill guide <NUM>.

Referring to <FIG>, in another illustrative example, a low friction bearing surface may include one or more sleeve portions <NUM> that extend around portions of the shaft <NUM>. The sleeve portions <NUM> are operative to further reduce friction between the shaft <NUM> and the drill guide <NUM>, <NUM> and to center the drill shaft <NUM> relative to the drill guide <NUM>, <NUM>. According to aspects of the present disclosure, the drill shaft <NUM> may be made of steel, nitinol or other metals. The sleeve portions <NUM> may be made of a plastic heat shrink material such as PEEK or PTFE, for example. In examples, the sleeve portions <NUM> may comprise plastic members that are press-fit or over-molded over the drill shaft <NUM>. The bearing material can be fiber reinforced to provide extra rigidity, for example. The coefficient of friction between the plastic sleeve portions <NUM> and an inner surface of the metal drill guide <NUM>, <NUM> is lower than between a metal surface of the drill shaft <NUM> and a metal inner surface of the drill guide <NUM>, <NUM>. In other examples, the low friction bearing surface and/or the drill guide <NUM>, <NUM> may be made from materials such as dissimilar metals with improved frictional properties to reduce particulate generation. According to another aspect of the present disclosure, the low friction bearing surface may include one or more separately created bearings that are later assembled onto the drill shaft <NUM>.

In the examples shown in <FIG>, the low friction bearing surface takes up clearance space between the drill <NUM> and the drill guide <NUM>, <NUM> to center the drill shaft <NUM> within the guide <NUM>, <NUM>, which improves alignment between the drill trajectory and the guide <NUM>, <NUM>. The reduced friction provided between the drill shaft <NUM> and the drill guide <NUM>, <NUM> also allows a smoother motion of the drill shaft <NUM> within the drill guide <NUM>, <NUM>, which improves controllability of the drill <NUM>. The reduced friction also reduces particulate generation, which can be harmful in a surgical environment.

Referring now to <FIG>, according to another aspect of the drill <NUM> of the present disclosure, a drill shaft <NUM> includes a series of lobes <NUM> and necked down regions <NUM>. The necked down regions <NUM> increase flexibility of the drill shaft <NUM>. The series of lobes <NUM> are located along the drill shaft <NUM> to provide a bearing surface between the drill shaft <NUM> and the drill guide <NUM>, <NUM>. In an illustrative example, the lobes <NUM> are adjacent a cutting portion <NUM> that is formed on or attached to the distal end of the drill shaft <NUM>. The lobes <NUM> can vary in number, size shape and spacing. The lobes <NUM> also provide reduced clearance space between the drill shaft <NUM> and the drill guide <NUM>, <NUM>. The reduced clearance increases alignment of the trajectory of the drill shaft <NUM> within the drill guide <NUM>, <NUM>. When the series of the lobes <NUM> are located within the drill guide <NUM>, <NUM>, spacing between the lobes <NUM> and the inner surface of the drill guide <NUM>, <NUM> reduces cocking of the drill <NUM> as it exits the guide <NUM>, <NUM>. The necked down regions <NUM> between the lobes <NUM> have reduced cross sectional area and thus lower the area moment of inertia of the drill shaft <NUM>. Deflection required for the drill shaft <NUM> to pass through a curved drill guide <NUM> is provided by the reduced area moment of inertia in the necked down region <NUM>. This allows the drill shaft <NUM> to bend with less force than a conventional drill shaft. Friction between the drill shaft <NUM> and the drill guide <NUM>, <NUM> is also reduced due to the improved flexibility provided by the necked down regions <NUM> of the drill shaft <NUM>. <FIG> and <FIG> illustrate an example of a counterbore <NUM> of the drill shaft <NUM> located distally to the series of lobes <NUM>. The counterbore <NUM> can be used to undercut the cutting portion <NUM> for reduction of the drilling force needed to move the drill <NUM> in hard bone media. In examples, each of a plurality of cutting elements <NUM> defined by the counterbore <NUM> have a cutting angle A of between about <NUM>-<NUM>° to allow for bone chip removal.

Although aspects of the present disclosure describe a drill shaft <NUM> having a series of lobes <NUM> and necked down regions <NUM> to reduce the area moment of inertia of the shaft <NUM> to increase flexibility of the drill <NUM>, persons having ordinary skill in the art should understand that other examples of the disclosed drill <NUM> may include other geometries that change the area moment of inertia of the shaft <NUM> to increase flexibility of the drill shaft <NUM>. According to another aspect of the present disclosure, flexibility of the drill <NUM> may be achieved via collapsible geometries that permit deflection or portions of the drill shaft <NUM>. As shown in <FIG>, whether the drill <NUM> exits the straight guide <NUM> (<FIG>) or the curved guide <NUM> (<FIG>), the drill <NUM> is aligned with the trajectory of the guide <NUM>, <NUM>.

Turning now to <FIG>, in use, the obturator <NUM> is inserted through the central passage <NUM> of the guide <NUM>, <NUM> (shown for exemplary purposes as straight guide <NUM>) and the combination is then passed over a guide wire <NUM> previously implanted in bone <NUM> at the desired site for tissue repair. Once the guide <NUM>, <NUM> reaches the desired site, the tip <NUM> of the guide <NUM>, <NUM> is placed against the bone <NUM> to stabilize the guide <NUM>, <NUM> for subsequent drilling and delivery of the suture anchor <NUM>. The guide wire <NUM> is then removed from the bone <NUM> and the obturator <NUM> is removed from the central passage <NUM> of the guide <NUM>, <NUM>.

Claim 1:
An anchor delivery system (<NUM>) comprising:
a guide (<NUM>, <NUM>) for insertion into a repair site, the guide (<NUM>, <NUM>) having a central passage (<NUM>) extending therethrough, a distal portion (24b) of the guide (<NUM>, <NUM>) being curved relative to a longitudinal axis of the guide (<NUM>, <NUM>);
an obturator (<NUM>) insertable through the passage of the guide (<NUM>, <NUM>) for blocking the passage during insertion of the guide (<NUM>, <NUM>) into the repair site, the obturator (<NUM>) including a shaft (<NUM>) having a flexible portion, a diameter of the flexible portion selected to allow bending of the obturator (<NUM>) so as to pass through the curve of the guide (<NUM>, <NUM>);
a drill (<NUM>) insertable through the passage of the guide (<NUM>, <NUM>) for forming a hole in a bone at the repair site, the drill (<NUM>) including a shank having a flexible portion, a diameter of the flexible portion selected to allow bending of the drill (<NUM>) so as to pass through the curve of the guide (<NUM>, <NUM>); and
an anchor delivery tool (<NUM>) insertable through the passage of the guide (<NUM>, <NUM>) for implanting an anchor (<NUM>) into the hole, the anchor delivery tool including an elongate member having a flexible proximal portion and a distal portion, a surface of the flexible proximal portion comprising a plurality of cuts permitting flexing of the anchor delivery tool about the cuts so as to pass through the curve of the guide (<NUM>, <NUM>), characterized in that the elongate member comprises a tapered region between the distal portion and the proximal portion, the distal portion comprising an area of reduced diameter (<NUM>) relative to the proximal portion.