Patent Description:
Described herein is a depth penetration limiter for use with a meniscal repair device which has a built-in, self-stopper feature to prevent the limiter from disengaging from the device housing. The self-stopper feature is a cantilevered flexure on a bottom surface of the limiter that deflects as it is moved through the housing. As the flexure passes the edge of a recess in the housing, the flexure returns to its original shape, trapping the flexure within the recess and preventing further distal movement of the limiter/depth tube. Additionally, a connection feature on the limiter advantageously provides increased pull-off resistance of the depth tube from the limiter.

Further examples of the tissue repair devices of this disclosure may include one or more of the following, in any suitable combination. In examples, a tissue repair device of this disclosure includes a handle having a proximal end and a distal end, and a needle assembly disposed at least partially within a channel extending through the handle. A depth tube including a cannulation is configured to receive at least a portion of the needle assembly therein. A limiter member includes a housing disposed within the handle and a shaft extending from the distal end of the handle. The shaft is configured to engage the cannulation of the depth tube. The limiter member has a finger-engageable actuator for allowing axial movement of the depth tube relative to the needle assembly. The housing of the limiter member includes a flexure configured to engage a recess in the housing to limit distal movement of the limiter member relative to the housing.

In further examples, a proximal side of the flexure includes a cantilevered surface configured to allow for proximal movement of the limiter member relative to the housing. In examples, an outer surface of the shaft of the limiter member has at least one connection feature for increasing pull-out resistance between the shaft of the limiter member and the cannulation of the depth tube. In examples, the at least one connection feature is at least one circumferential rib formed by a conical section of the shaft of the limiter member. In other examples, the at least one connection feature is a plurality of barbs on an outer surface of the shaft of the limiter member. In examples, the handle has a hub coupled to a distal end of a tube extending through the handle, and the housing of the limiter member is disposed within the hub. In examples, a top portion of the housing extends through an open slot in the hub. In examples, a proximal portion of the depth tube and a distal end of the needle assembly include coordinated markings for indicating a tissue penetration depth of the needle assembly. In examples, the depth tube is comprised of a flexible material such that a proximal end of the depth tube configured to stretch about an outer surface of the shaft of the limiter member. In examples, the limiter member includes tabs for successively engaging grooves of the handle upon longitudinal movement of the limiter member within the handle.

Further examples of a tissue repair device of this device include a handle having a proximal end and a distal end, and a needle assembly disposed at least partially within a channel extending through the handle. A depth tube including a cannulation is configured to receive at least a portion of the needle assembly therein. A limiter member includes a housing disposed within the handle and a shaft extending from the distal end of the handle. The shaft is configured to engage the cannulation of the depth tube. The limiter member has a finger-engageable actuator for allowing axial movement of the depth tube relative to the needle assembly. An outer surface of the shaft of the limiter member includes at least one connection feature for increasing pull-out resistance between the shaft of the limiter member and the cannulation of the depth tube.

In further examples, the housing of the limiter member includes a flexure configured to engage a recess in the housing to limit distal movement of the limiter member relative to the housing. In examples, a proximal side of the flexure includes a cantilevered surface configured to allow for proximal movement of the limiter member relative to the housing. In examples, the at least one connection feature is at least one circumferential rib formed by a conical section of the shaft of the limiter member. In other examples, the at least one connection feature is a plurality of barbs on an outer surface of the shaft of the limiter member. In examples, the handle includes a hub coupled to a distal end of a tube extending through the handle, and the housing of the limiter member is disposed within the hub. In examples, a top portion of the housing extends through an open slot in the hub. In examples, a proximal portion of the depth tube and a distal end of the needle assembly include coordinated markings for indicating a tissue penetration depth of the needle assembly. In examples, the depth tube is comprised of a flexible material such that a proximal end of the depth tube is configured to stretch about an outer surface of the shaft of the limiter member. In examples, the limiter member includes tabs for successively engaging grooves of the handle upon longitudinal movement of the limiter member within the handle.

These and other features and advantages is apparent from a reading of the following detailed description and a review of the associated drawings.

The disclosure is 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 to 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. Use of the terms "above," "below" and the like is intended only to help in the clear description of the present disclosure and are not intended to limit the structure, positioning and/or operation of the tissue repair device in any manner.

Turning now to <FIG>, an example of a tissue repair device <NUM>, including the depth penetration limiter <NUM> of the present disclosure, is shown in an assembled view. The device <NUM> generally includes a handle <NUM>, a knob <NUM> coupled to the handle <NUM>, a tube <NUM> disposed within the knob <NUM> and the handle <NUM>, and a hub <NUM> coupled to the tube <NUM>. The depth penetration limiter <NUM> of this disclosure is disposed within the hub <NUM> and coupled to a depth tube <NUM>, as further described below. A needle assembly <NUM> extends through the depth tube <NUM> and houses at least one suture anchor (not shown) for deployment from the needle assembly <NUM> into tissue. Other non-limiting examples of the handle <NUM>, the knob <NUM>, the tube <NUM>, the hub <NUM> and the needle assembly <NUM> are disclosed in <CIT>.

Turning now to <FIG>, examples of the hub <NUM> are shown in detailed views. <FIG> shows the assembled hub <NUM> having a first part <NUM> (<FIG>) and a second part <NUM> (<FIG>). When assembled, the first part <NUM> and the second part <NUM> define a cannulation <NUM> extending through the hub <NUM>. Both the first part <NUM> and the second part <NUM> include a first section 171a, 172a and a second section 171b, 172b. An open slot <NUM> extends between the first sections 171a, 172a in communication with the cannulation <NUM>. The first sections 171a, 172a also include a front portion 171a', 172a' and grooves 171a",172a", the purpose of which will be described in more detail below. Each part <NUM>, <NUM> also includes tabs 171d, 172d located on an outer surface of the second sections 171b, 172b. The second sections 171b, 172b are housed within the tube <NUM> (<FIG>) such that the tabs 171d, 172d are disposed within holes <NUM> of the tube <NUM>, thereby coupling the hub <NUM> to the tube <NUM>.

Turning now to <FIG>, an example of a depth tube <NUM> is shown in a detailed view. The depth tube <NUM> includes a distal portion 300a, a proximal portion 300b, and a cannulation 300c for passage of the needle assembly <NUM>. In examples, the proximal portion 300b of the depth tube <NUM> includes markings 300d. The depth tube <NUM> can be made of a flexible material such that the proximal portion 300b of the depth tube <NUM> can be stretched about an outer surface of the depth penetration limiter <NUM>, as further described below.

As shown in <FIG>, the depth penetration limiter <NUM> of this disclosure is coupled to the proximal portion 300b of the depth tube <NUM> while the needle assembly <NUM> extends from the distal portion 300a of the depth tube <NUM>. A distal end of the needle assembly <NUM> also includes markings <NUM> for indicating a penetration depth of the needle assembly <NUM> during repair. In use, as the depth tube <NUM> is moved longitudinally along the needle assembly <NUM>, the front portions 171a', 172a' of the hub <NUM> and a front portion 300a' of the depth tube <NUM> will continue to align with the respective markings 300d, <NUM> such that the markings 300d, <NUM> with which the fronts portions 171a', 172a', 300a' are respectively aligned will be equivalent to each other. For example, when the front portions 171a', 172a' are aligned with a marking 300d that corresponds to <NUM>, the front portion 300a' is also aligned with a marking <NUM> that corresponds to <NUM>.

Turning now to <FIG>, the depth penetration limiter <NUM> of this disclosure is shown in a side view (<FIG>) and an isometric view (<FIG>). The depth penetration limiter <NUM> includes a shaft <NUM>, a housing <NUM> coupled to the shaft <NUM>, and a cannulation <NUM> for passage of the needle assembly <NUM> and/or an actuator <NUM> (<FIG>). In examples, a flexure <NUM> is coupled to an inner surface of the cannulation <NUM> such that the flexure extends below the housing <NUM>, the purpose of which will be described in more detail below. The shaft <NUM> includes a connection feature <NUM> which is configured to couple the shaft <NUM> to the proximal portion 300b of the depth tube <NUM>. In examples, the connection feature <NUM> is one or more circumferential ribs <NUM> defined by a cone-shaped section <NUM> of the shaft <NUM>. In other examples, shown in <FIG>, the connection feature <NUM> is a plurality of barbs <NUM> disposed about a circumference of the shaft <NUM>. In examples, a cross-section of the barbs <NUM> could be cylindrical, mirror-symmetric, rectangular, triangular, pentangular, star-shaped etc. The connection feature <NUM> is configured to provide sufficient assembly force as well as to increase pull-off resistance of the depth tube <NUM> from the shaft <NUM>. The depth tube <NUM> can be assembled to the shaft <NUM> by stretching the proximal portion 300b of the depth tube <NUM> around the connection feature <NUM> and allowing the depth tube <NUM> to relax back around the surface of the shaft <NUM>.

Further examples (not shown) of the depth tube <NUM> and/or the connection feature <NUM> are contemplated by this disclosure. For example, the depth tube <NUM> could include a window to act as a catch to the connection feature <NUM>. Similarly, there could be many catches on the depth tube <NUM> acting as a ratchet-pawl style mechanism with the connection feature <NUM> of the shaft <NUM>. In other examples, surface roughness, material combinations, and various other surface parameters could be adjusted on the depth tube <NUM> and/or the shaft <NUM> to achieve the design intent. In other examples, the connection feature <NUM> could be an asymmetric "mini-barb" requiring more force to remove from the depth tube <NUM> than to assemble to the depth tube <NUM>. In further examples, a round cross-section of one of the depth tube <NUM> or the shaft <NUM> could be mated to a square cross-section of the other of the depth tube <NUM> or the shaft <NUM>. In other examples, the shaft <NUM> and the depth tube <NUM> could utilize a helical interface to screw together. In further examples, the mating surface between the depth tube <NUM> and the shaft <NUM> could be an inner diameter of a boss on the shaft <NUM> and an outer diameter of the depth tube <NUM>.

Turning now to <FIG>, in further examples of the depth penetration limiter <NUM> of this disclosure, the housing <NUM> has a top portion 402a for extending through the slot <NUM> in the hub <NUM> (<FIG>), and a bottom portion 402b connected to the shaft <NUM>. The top portion 402a includes upper tabs <NUM>. The housing <NUM> is located within the hub <NUM> such that the upper tabs <NUM> are located within the grooves 171a", 172a" of the hub <NUM>. The cannulation <NUM> is configured to allow passage of an actuator <NUM> for deploying anchors from the needle assembly <NUM>. Longitudinal movement of the depth tube <NUM> occurs via pressing on the top portion 402a of the housing <NUM> in a direction towards the bottom portion 402b, so as to remove the upper tabs <NUM> from one of the grooves 171a",172a". The housing <NUM> can thus be moved longitudinally and then the top portion 402a can be released such that the upper tabs <NUM> are deposited into other one of the grooves 171a",172a". Meanwhile, the flexure <NUM> deforms within the hub <NUM> and slides along a bottom surface <NUM> of the cannulation <NUM> of hub <NUM>. However, once the upper tabs <NUM> reach the distal-most grooves 171a", 172a", the flexure <NUM> is configured to engage recesses <NUM> in the bottom surface <NUM> of the hub <NUM> and return to their original shape, preventing further distal movement of the housing <NUM> relative to the hub <NUM>. Notably, a proximal side 409a of the flexure <NUM> is cantilevered such that proximal movement of the housing <NUM> allows the flexure <NUM> to slide out of the recesses <NUM> to enable proximal movement of the depth tube <NUM>. The cantilever of the proximal side 409a furthermore evenly distributes stress along the length of the cantilever.

Claim 1:
A tissue repair device comprising:
a handle (<NUM>) having a proximal end and a distal end;
a needle assembly (<NUM>) disposed at least partially within a channel extending through the handle (<NUM>);
a depth tube (<NUM>) including a cannulation (300c) receiving at least a portion of the needle assembly (<NUM>) therein; and
a limiter member comprising a housing (<NUM>) disposed within the handle (<NUM>) and a shaft (<NUM>) extending from the distal end of the handle (<NUM>), wherein the shaft is coupled to a distal end of the housing of the limiter member, the shaft (<NUM>) configured to engage the cannulation (<NUM>) of the depth tube (<NUM>), the limiter member having a finger-engageable actuator (<NUM>) for allowing axial movement of the depth tube (<NUM>) relative to the needle assembly (<NUM>);
wherein the handle (<NUM>) comprises a hub (<NUM>) coupled to a distal end of a tube (<NUM>) extending through the handle (<NUM>), wherein the housing of the limiter member is disposed within the hub (<NUM>),
characterized in that the housing (<NUM>) of the limiter member comprises a flexure (<NUM>) configured to engage a recess (<NUM>) in the hub to prevent further distal movement of the limiter member relative to the hub (<NUM>) when the finger-engageable actuator is pressed.