Patent Description:
Conventional medical procedures routinely involve the use of surgical tools to assist medical professionals in approaching, viewing, manipulating, or otherwise effecting treatment at localized surgical sites. Some of these medical procedures may involve surgical techniques such as drilling, shaping, or decortication of bone using a rotary instrument, where a cutting accessory, such as a high-speed bur, rotates at speeds in excess of <NUM> rpm to remove tissue. During use, contact between non-cutting portions of the bur (e.g., a shank) and soft tissue can result in tissue wrap, in which friction between the rotating shank and the soft tissue causes the soft tissue to be pulled around the shank. Surgeons must be mindful to avoid unexpected tissue wrap.

<CIT> discloses an ultrasonic aspirator which includes a body, a shield, an endoscope, a headpiece to vibrate and destroy tissue and an irrigation tube adapted to provide fluid to the body and the headpiece via an irrigation port for removing destroyed tissue. The shield is adapted to carry fluid for aspiration of sonicated tissue. An endoscope tube extends from the endoscope toward the headpiece and has an endoscope opening proximal of the headpiece to the body.

An irrigation sleeve with the features of claim <NUM> is provided. Further, optional features of the irrigation sleeve are defined in the dependent claims. In particular, the irrigation sleeve is for use with a surgical system comprising an irrigation source, a rotary instrument having a tube extending to a distal tube end, and a cutting accessory having a head and a shank adapted to be rotatably supported by the tube of the rotary instrument, wherein the irrigation sleeve includes a sleeve body extending between a proximal sleeve portion and a distal sleeve portion; a first lumen formed in the sleeve body for receiving at least a portion of the tube of the rotary instrument; a second lumen formed in the sleeve body and spaced out of fluid communication with the first lumen; a shield extension coupled to the sleeve body and extending between a proximal shield portion and a distal shield portion, the proximal shield portion engaged with the distal sleeve portion, the shield extension adapted to minimize tissue wrap about the cutting accessory shank; and a third lumen formed in the shield extension and in communication with the first lumen.

With reference to the Figures, wherein like numerals indicate like parts throughout the several views, a surgical system <NUM> is shown in <FIG>. The surgical system <NUM> generally comprises an irrigation system <NUM> and a surgical tool, each of which will be described in greater detail below. In the representative embodiment illustrated herein, the surgical tool is realized as a rotary instrument <NUM>. A console <NUM> is employed to control both the irrigation system <NUM> and the surgical tool via a footswitch <NUM>. However, as will be appreciated from the subsequent description below, both the irrigation system <NUM> and the surgical tool could be configured and controlled in a number of different ways. By way of non-limiting example, the surgical tool and the irrigation system <NUM> could be controlled independently, such as by discrete consoles or input devices. Suitable construction and operation of several subsystems of the surgical system <NUM> and irrigation system <NUM> are disclosed in commonly owned International Publication No. <CIT>.

The use of high-speed drills, rotating burs, open-window shavers, and the like necessarily results in the accumulation of debris at the surgical site <NUM>. Here, the surgical system <NUM> employs the irrigation system <NUM> to direct fluid towards the surgical site <NUM> to loosen, float, or displace debris for subsequent removal (for example, by suction). The irrigation system <NUM> may also be used to ensure proper operation of surgical tools during procedures by clearing debris from endoscopes, cooling cutting accessories, preventing the accumulation of debris on cutting accessories, and the like.

Referring to <FIG>, the surgical tool is configured as the rotary instrument <NUM>, which drives a cutting accessory, generally indicated at <NUM>. Here, the cutting accessory <NUM> is adapted to assist a medical professional in approaching or manipulating a surgical site <NUM> by effecting the removal of tissue, bone, and the like. To this end, the cutting accessory <NUM> is depicted throughout the drawings as a bur. The cutting accessory <NUM> could be of a number of different types or configurations, such as shavers, rasps, ultrasonic cutting tools, etc. As will be discussed below, several cutting accessories <NUM> (see <FIG>) are available to suit the needs associated with various surgical sites <NUM>. Specifically, different length cutting accessories 52A, 52B, 52C, i.e. those having different driveshaft lengths can be used with the rotary instrument <NUM>. While the representative surgical tool illustrated herein is realized as a rotary instrument <NUM>, the surgical tool could be configured in a number of different ways, including but not limited to an endoscope, a reciprocating tool, un ultrasonic tool, and the like, from any number of components controlled in any suitable way and operable to power the cutting accessory <NUM>.

The rotary instrument <NUM> generally comprises a housing <NUM>, which supports a coupler <NUM> and a motor <NUM> therein (depicted schematically in <FIG>). The motor <NUM> generates rotational torque that is translated to the coupler <NUM> which, in turn, is configured to releasably secure the cutting accessory <NUM> for concurrent rotation with the motor <NUM>. The rotary instrument <NUM> further comprises a tube, generally indicated at <NUM>, which extends from the housing <NUM> to a distal tube end <NUM>. The cutting accessory <NUM>, in turn, comprises a head <NUM> and a shank <NUM> extending from the head <NUM>. The shank <NUM> is adapted to be rotatably supported by the tube <NUM> of the rotary instrument <NUM>, and is secured axially to the rotary instrument <NUM> via the coupler <NUM> (not shown in detail). In the exemplary cutting accessory <NUM> illustrated herein, the head <NUM> is realized as a bur, but could be of any suitable type or configuration, as noted above.

In the exemplary rotary instrument <NUM> illustrated in <FIG>, the motor <NUM> is powered via a wired electrical connection with the console <NUM> and is controlled via the footswitch <NUM>, which is similarly disposed in electrical communication with the console <NUM>. However, the rotary instrument <NUM> could be configured with or without a wired motor <NUM> controlled by a console <NUM>. By way of non-limiting example, the rotary instrument <NUM> could be powered pneumatically or could be driven by a motor disposed within the console. Similarly, while the footswitch <NUM> is employed to effect control of the motor <NUM> via the console <NUM>, other types of user inputs are contemplated. For example, hand switches could be operatively attached to the housing <NUM> of the rotary instrument <NUM> to control rotation of the motor <NUM>, or the console <NUM> could control rotation of the motor <NUM> without the footswitch <NUM>.

The irrigation system <NUM> of the surgical system <NUM> is configured to direct fluid from an irrigation source <NUM> towards the surgical site <NUM>. In <FIG>, the irrigation source <NUM> comprises a fluid reservoir <NUM> realized as a bag of saline solution disposed in fluid communication with a motor-driven pump cassette <NUM> which, in turn, is disposed in fluid communication with a line <NUM>. Here, the pump cassette <NUM> is operatively attached to the console <NUM>, is controlled via the footswitch <NUM>, and is configured to direct fluid from the fluid reservoir <NUM> to the line <NUM>. The line <NUM>, in turn, is adapted to releasably attach to an irrigation sleeve assembly, generally indicated at <NUM>, to direct fluid towards the surgical site <NUM> as described in greater detail below in connection with <FIG>. An irrigation sleeve suitable for certain implementations of the irrigation system is disclosed in aforementioned commonly owned International Publication No. <CIT>.

The irrigation sleeve <NUM> is adapted to be coupled to the tube <NUM> of the rotary instrument <NUM> and, in certain configurations, is configured to project a fluid jet FJ next to and beyond the head <NUM> of the cutting accessory <NUM> towards the surgical site <NUM> (see <FIG>). To this end, the illustrated irrigation system <NUM> may further comprise a feeder tube <NUM>, a connector <NUM>, and an adhesive member <NUM>. The feeder tube <NUM> is interposed in fluid communication between the connector <NUM> and the irrigation sleeve <NUM>, and the connector <NUM> is adapted for attachment to the line <NUM> of the irrigation system <NUM>. Thus, fluid displaced by the pump cassette <NUM> flows from the irrigation source <NUM>, through the line <NUM> and the feeder tube <NUM>, to the irrigation sleeve <NUM> which, in turn, projects the fluid jet FJ, as noted above, and as described in greater detail below.

The feeder tube <NUM> can be coupled to the irrigation sleeve <NUM> and to the connector <NUM> in a number of different ways, such as via ultraviolet bonding, gluing, a barbed connection, and the like. While the connector <NUM> is adapted for releasable attachment to the line <NUM> described above, other configurations are contemplated. For example, the feeder tube <NUM> could be of various lengths and may be adapted for attachment directly to the irrigation source <NUM>, directly to the pump cassette <NUM>, to a valve interface, and the like. The adhesive member <NUM> is coupled to the feeder tube <NUM> and is configured to secure the feeder tube <NUM> to the housing <NUM> of the rotary instrument <NUM> during use.

Conventional irrigation systems <NUM> can be used in connection with a number of different types of surgical tools. As such, irrigation systems <NUM> are generally adjustable in terms of fluid flowrate or pump speed. Thus, depending on the type of medical or surgical procedure, the specific configuration of the surgical tool being used, or the preferences of the medical professional, the irrigation system <NUM> may be configured to supply fluid at a particular, adjustable flowrate (for example, by selecting a certain pump speed). The irrigation systems <NUM> can be configured and controlled in a number of different ways. Specifically, the irrigation system <NUM> could be controlled via a discrete console, as noted above. Moreover, while the pump cassette <NUM> is advantageously driven with an electric motor via the console <NUM>, other arrangements of irrigation sources <NUM> are contemplated herein. For example, displacement of fluid from the fluid reservoir <NUM> towards the irrigation sleeve <NUM> could be achieved via a manually-actuated pump. Furthermore, the irrigation system <NUM> and/or the surgical tool could incorporate, or otherwise cooperate with, a suction system or other systems, tools, and the like utilized in connection with medical or surgical procedures.

Furthermore, certain elements of the irrigation system <NUM> may be supplied individually or combined as a sub-assembly. For example, irrigation sleeve <NUM> may be further defined as an irrigation assembly wherein the feeder tube <NUM>, the connector <NUM>, and the adhesive member <NUM> are pre-assembled with the irrigation sleeve <NUM> as a single-use disposable. Alternatively, each of the components may be available as a kit to be assembled by the user. Some or all of these components may also be reusable owing to construction comprising a sterilizable material, as will be discussed in further detail below.

Referring now to <FIG>, the illustrated embodiments of the irrigation sleeve <NUM> are adapted to be coupled to the tube <NUM> of the rotary instrument <NUM>, as noted above. The irrigation sleeve <NUM> has a generally elongated shape with two ends, a first end <NUM> and a second or working end <NUM>, which are spaced along a longitudinal axis A1. Generally speaking, the first end <NUM> is arranged proximal to the user (surgeon) and the working end <NUM> is arranged distal to the user (surgeon). The first end <NUM> is configured to receive the rotary instrument <NUM> and the working end <NUM> is configured to receive the cutting accessory <NUM>, i.e. the working end <NUM> is nearer to the head <NUM> of the cutting accessory <NUM>, which performs the tissue removal procedure.

In one configuration, shown in <FIG>, the irrigation sleeve <NUM> comprises a sleeve body <NUM> that extends between a proximal sleeve end <NUM> and a distal sleeve end <NUM> to define a length <NUM>. The sleeve body <NUM> has an outer surface <NUM> and an inner surface <NUM>, and defines a generally annular profile. The inner surface <NUM> is accessible through a first lumen <NUM> formed in the proximal sleeve end <NUM> of the sleeve body <NUM>. The first lumen <NUM> receives at least a portion of the tube <NUM> of the rotary instrument <NUM>, such that the head <NUM> of the cutting accessory <NUM> is arranged at the working end <NUM> of the irrigation sleeve <NUM> when the cutting accessory <NUM> is installed in the rotary instrument <NUM>. As will be appreciated from the subsequent description below, the irrigation sleeve <NUM> may be first positioned onto the tube <NUM> of the rotary instrument <NUM>, and then the cutting accessory <NUM> may be subsequently secured to the rotary instrument <NUM>. An irrigation lumen <NUM>, spaced from the first lumen <NUM>, is also formed in the sleeve body <NUM> and is isolated from the first lumen <NUM> such that no fluid communication occurs between the first lumen <NUM> and the irrigation lumen <NUM>. Best shown in the cross-sectional view of <FIG>, both the first lumen <NUM> and the irrigation lumen <NUM> are defined in the sleeve body <NUM>.

Best shown in <FIG>, the irrigation lumen <NUM> comprises an irrigation lumen inlet <NUM> and an irrigation lumen outlet <NUM>. The irrigation lumen inlet <NUM> is adapted for fluid communication with the irrigation source <NUM> via the feeder tube <NUM> and the line <NUM> (see <FIG>). The irrigation lumen inlet <NUM> is defined in a lumen support <NUM>, which protrudes from the sleeve body <NUM> near the proximal sleeve end <NUM>.

The irrigation lumen <NUM> extends from the irrigation lumen inlet <NUM> to the irrigation lumen outlet <NUM>, which is defined in the sleeve body <NUM>. The irrigation lumen outlet <NUM> is arranged to direct fluid adjacent to the head <NUM> of the cutting accessory <NUM>. In certain configurations, the irrigation lumen outlet <NUM> promotes projecting the fluid jet FJ away from the shank <NUM> of the cutting accessory <NUM>. In certain other configurations, the irrigation lumen outlet <NUM> promotes projecting the fluid jet FJ substantially parallel with the shank <NUM> of the cutting accessory <NUM>. As noted above, the sleeve body <NUM> could have other profiles, configurations, and the like (see, for example, <FIG>).

Throughout the specification, the term irrigation sleeve <NUM> is used to refer to one type of instrument sleeve that is capable of providing irrigation to a location near the surgical site <NUM>. Irrigation may be implemented into the surgical system <NUM> by providing an irrigation lumen <NUM>, which may be integrated with, or separate from, the instrument sleeve so as to enable the instrument sleeve to direct fluid toward the surgical site <NUM>. In this way, the irrigation sleeve is realized as an instrument sleeve used in combination with an irrigation lumen <NUM>. Alternative configurations of an instrument sleeve combining aspects of the sleeve body <NUM> and shield extension <NUM> discussed herein may be realized without the irrigation lumen described above. Instrument sleeves without an irrigation lumen may be provided for use in procedures where irrigation is not used or where alternative irrigation systems <NUM> are used.

The irrigation sleeve <NUM> comprises the sleeve body <NUM> and further comprises a shield extension <NUM> coupled to the sleeve body <NUM>. When removing tissue with the cutting accessory <NUM>, loose material may adhere to the shank <NUM> and cause tissue wrap. Specifically, when the shank <NUM> is spinning and contacts tissue, surface friction causes the loose tissue to adhere to the shank <NUM>. Due to the high rotational speed of the shank <NUM> loose tissue that adheres to the shank <NUM> has a tendency to wrap around the shank <NUM>. When the loose tissue wraps around the shank <NUM> tension between the loose tissue and the shank <NUM> increases. This increase in tension between the loose tissue and the shank <NUM> may continue until the shank <NUM> experiences adverse effects. Therefore, in order to minimize tissue wrap, unintended contact between the shank <NUM> and the tissue should be minimized. By decreasing the amount of the shank <NUM> that is exposed between the distal tube end <NUM> and the head <NUM>, the shank <NUM> is less likely to contact loose tissue, which may bind or adhere to the shank <NUM>. In other words, in such a configuration, there is a much smaller portion of the shank <NUM> that is exposed to tissue because the portion of the shank <NUM> that is between the head <NUM> and the distal tube end <NUM> is surrounded by the shield extension <NUM>. This makes the shank <NUM>, and thus the cutting accessory <NUM> more reliable and reduces potential trauma during use.

As used throughout the specification the terms proximal and distal refer to the arrangement of a first portion relative to a second portion of the respective element. Accordingly, the irrigation sleeve <NUM> has a proximal sleeve portion <NUM> and a distal sleeve portion <NUM>. The proximal sleeve portion <NUM> is nearer to the first end <NUM> than the distal sleeve portion <NUM>. Said differently, the distal sleeve portion <NUM> is nearer to the working end <NUM> than the proximal sleeve portion <NUM>. The spatial relationships used to describe of the various elements of the irrigation sleeve <NUM> refer only to the configuration of their respective element. Specifically, both the sleeve body <NUM> and the shield extension <NUM> have respective proximal and distal portions, the distal portion being associated with the working end <NUM> and the proximal portion being associated with the first end <NUM> only in relation to the corresponding portion of the respective element.

More specifically, the sleeve body <NUM> has a proximal body portion <NUM> and a distal body portion <NUM>. The proximal body portion <NUM> is nearer to the first end <NUM> than the distal body portion <NUM>. Said differently, the distal body portion <NUM> is nearer to the working end <NUM> than the proximal body portion <NUM>.

In the same way, the shield extension <NUM> has a proximal shield portion <NUM> and a distal shield portion <NUM>. The proximal shield portion <NUM> is nearer to the first end <NUM> than the distal shield portion <NUM>. Said differently, the distal shield portion <NUM> is nearer to the working end <NUM> than the proximal shield portion <NUM>. The shield extension <NUM> further has an outer shield surface <NUM> and defines a shield lumen <NUM> that extends between the proximal shield portion <NUM> and the distal shield portion <NUM>. The outer shield surface <NUM> and the shield lumen <NUM> cooperate to define an annular profile of the shield extension <NUM>, the outer shield surface <NUM> having a shield outer diameter <NUM> and the shield lumen <NUM> having a shield lumen diameter <NUM>, the shield outer diameter <NUM> being greater than the shield lumen diameter <NUM>.

As mentioned above, the shield outer diameter <NUM> is greater than the shield lumen diameter <NUM>, however as can be seen in <FIG>, the shield outer diameter <NUM> in the proximal shield portion <NUM> is greater than the shield outer diameter <NUM> in the distal shield portion <NUM>. That is to say that the shield outer diameter <NUM> is tapered along the shield extension <NUM> from the proximal shield portion <NUM> to the distal shield portion <NUM>. When the shield lumen diameter <NUM> is constant, the tapered shield outer diameter <NUM> has the effect of reducing a thickness of the shield extension <NUM> along the shield extension <NUM>. Alternatively, it is contemplated that the shield lumen diameter <NUM> could increase along the shield extension from the proximal shield portion <NUM> to the distal shield portion <NUM> while the shield outer diameter <NUM> is constant, which would similarly reduce the thickness of the shield extension <NUM> nearer to the working end <NUM>.

Cooperation between the sleeve body <NUM> and the shield extension <NUM> aligns the outer surface <NUM> of the sleeve body <NUM> adjacent to the outer shield surface <NUM> such that a continuous exterior surface of the irrigation sleeve <NUM> is formed. A length indicia <NUM> is arranged on the exterior surface for indicating a length of the irrigation sleeve <NUM>. Specifically, the shield extension <NUM> comprises the length indicia <NUM>, which is arranged on the outer shield surface <NUM> spaced at a predetermined distance from the proximal shield portion <NUM>. The length indicia <NUM> may be radial scores <NUM> arranged along the longitudinal axis A1 concentric with the outer shield surface <NUM> of the shield extension <NUM>. The radial scores <NUM> provide a groove that can be used to guide a scalpel or other cutting instrument for severing the shield extension at the length indicia <NUM>.

As will be discussed in further detail below, each of the length indicia <NUM> indicates one or more predetermined lengths that facilitate use of different cutting accessories 52A, 52B, 52C. More specifically, a shield length <NUM> is defined between each of the length indicia <NUM> and a proximal reference <NUM> of the sleeve body <NUM>. A frangible segment <NUM> is defined between each length indicia <NUM> and the distal shield portion <NUM> that is configured to be removed from the shield extension <NUM>. By removing the frangible segment <NUM> a cutting accessory 52C having a shorter shank 66C may be engaged with the rotary instrument <NUM> such that the head 64C is arranged adjacent to the distal shield portion <NUM>.

In some configurations the length indicia <NUM> may define a plurality of weakened segments <NUM>, which are arranged along the distal sleeve portion <NUM> at predetermined intervals for facilitating customization of the length <NUM> of the sleeve body <NUM>. The length <NUM> of the sleeve body <NUM> may be customized by removing at least one of the plurality of weakened segments <NUM> from the sleeve body <NUM>. According to one method, the user may remove a weakened segment <NUM> by applying a force, which exceeds the material's strength, to a weakened segment <NUM>, thereby causing the sleeve body <NUM> to break where the force is concentrated. The user may use their hands to snap the weakened segments <NUM> or a tool to increase the force applied.

While the length indicia <NUM> are illustrated throughout the various figures as radial scores <NUM> formed in the sleeve body <NUM>, alternative length indicia <NUM> are contemplated. For example, the length indicia <NUM> may take the form of a ruler scale printed on the outer shield surface <NUM>, which provides a visual reference of a distance from the distal tube end <NUM> when the irrigation sleeve <NUM> installed on the rotary instrument <NUM>. The length indicia <NUM> may be printed using screen printing techniques, engraved using laser engraving techniques, etched via a chemical process, or applied via an adhesive label. Further, the length indicia <NUM> may be integrally formed with the shield extension <NUM> raised from the outer shield surface <NUM> or sunk into the outer shield surface <NUM>. It is further contemplated that the irrigation sleeve <NUM> may be used in combination with a jig (not shown) having a length indicia to transfer predetermined measurements to the exterior surface in furtherance of customizing the length <NUM> of the irrigation sleeve <NUM>.

The shield extension <NUM> may be manufactured from a polymer material in various processes known in the art. The polymer may be chosen for its specific properties, which may a thermoplastic polymer that is resilient and durable in order to resist abrasion from the cutting accessory <NUM> during use. In one configuration, the shield extension <NUM> is constructed from a polyether ether ketone (PEEK) thermoplastic polymer. Similarly, some or all of the shield extension <NUM> may be provided with a smooth coating to further resist abrasion. In one example, the shield lumen <NUM> may be provided with a slippery or low coefficient of friction coating, such as polytetrafluoroethylene. Alternatively or additionally, a biocompatible material may be deposited on the shield extension <NUM>. In one configuration, the shield extension <NUM> is manufactured from a sterilizable material. In other configurations, the shield extension <NUM> may be manufactured from a transparent or semi-transparent material so as to promote visibility of the rotary instrument <NUM> during use. However, the shield extension <NUM> could be manufactured from any suitable material or combination or materials.

While the sleeve body <NUM> and the shield extension <NUM> are shown throughout the figures as separate components, the irrigation sleeve <NUM> may be realized by a unitary, one-piece construction whereby the sleeve body <NUM> and the shield extension <NUM> are formed in an integral manner. Here, the distal sleeve portion <NUM> is attached to the proximal sleeve portion <NUM> by manufacturing the irrigation sleeve <NUM> as a singular body with the distal sleeve portion <NUM> protruding from the proximal sleeve portion <NUM>. In these realizations, the combined proximal sleeve portion <NUM> and the distal sleeve portion <NUM> each define proximal and distal sub-portions that are associated with the corresponding proximal and distal portions of either the sleeve body <NUM> or the shield extension <NUM>.

Referring specifically to <FIG>, further details of the irrigation sleeve <NUM> are shown. The view facing the first end <NUM> of the irrigation sleeve <NUM> of <FIG> depicts the inner surface <NUM> of the sleeve body <NUM>. The inner surface <NUM> is accessible through the first lumen <NUM> defined in the proximal sleeve end <NUM> for receiving at least a portion of the tube <NUM> of the rotary instrument <NUM>. <FIG> shows the irrigation sleeve <NUM> slid over the tube <NUM> into a partially installed position. The distal tube end <NUM> and a portion of the tube <NUM> of the rotary instrument <NUM> have been partially inserted into the first lumen <NUM> such that further insertion of the tube <NUM> into the first lumen <NUM> will cause the distal tube end <NUM> to move toward the distal sleeve end <NUM> until the irrigation sleeve <NUM> reaches a fully installed position, shown in <FIG>.

Shown in <FIG>, the first lumen <NUM> has a proximal region <NUM>, a transition region <NUM>, and a first lumen apex <NUM>. The first lumen <NUM> extends from the proximal sleeve end <NUM>, through the proximal region <NUM> and proceeds distally through the transition region <NUM> to the first lumen apex <NUM>. The proximal region <NUM> is arranged nearest to the proximal sleeve end <NUM> and the transition region <NUM> is immediately distal to the proximal region <NUM>. In this way, the first lumen <NUM> defines the inner surface <NUM> of the sleeve body <NUM>, which extends between the proximal sleeve end <NUM> and the first lumen apex <NUM>.

The proximal region <NUM> of the first lumen <NUM> defines a first lumen diameter <NUM>, which is sized to accommodate the tube <NUM> of the rotary instrument <NUM>. In the transition region <NUM> a second lumen diameter <NUM> is defined at the first lumen apex <NUM>, which is smaller than the first lumen diameter <NUM>. In order for the inner surface <NUM> to extend between the proximal sleeve end <NUM> and the first lumen apex <NUM>, the transition region <NUM> of the first lumen <NUM> is tapered toward the first lumen apex <NUM> between first lumen diameter <NUM> and the second lumen diameter <NUM>. Depending on the material from which the sleeve body <NUM> is constructed the first lumen diameter <NUM> may range from slightly smaller than the tube <NUM> to slightly larger than the tube <NUM>. Specifically, materials that exhibit more elastic properties may be sized slightly smaller than the tube <NUM> such that upon assembly of the irrigation sleeve <NUM> and the rotary instrument <NUM> the sleeve body <NUM> is stretched, which creates a compressive force on the tube <NUM> thereby promoting secure attachment of the irrigation sleeve <NUM> to the rotary instrument <NUM>.

The proximal shield portion <NUM> of the shield extension <NUM> further comprises a shoulder portion <NUM>, which defines a shoulder diameter <NUM>. The shoulder diameter <NUM> is less than the first lumen diameter <NUM> such that the shoulder portion <NUM> can be engaged with the distal body portion <NUM> of the sleeve body <NUM> near the first lumen apex <NUM>. The shield extension <NUM> is assembled to the sleeve body <NUM> by inserting the shoulder portion <NUM> into the distal body portion <NUM> and the first lumen <NUM>. To this end the shoulder diameter <NUM> is approximately equal to the second lumen diameter <NUM> such that the shoulder portion <NUM> is an interference fit with the sleeve body <NUM>, which retains the shield extension <NUM> to the sleeve body <NUM>.

As seen here, the shield extension <NUM> further comprises a pilot member <NUM> coupled to the proximal shield portion <NUM> and extending into the first lumen <NUM> in a proximal direction toward the first end <NUM>. The pilot member <NUM> is configured for engagement with a portion of the tube <NUM> of the rotary instrument <NUM> to provide rigidity to the sleeve body <NUM>. The pilot member <NUM> has a generally annular profile with an inner surface defined by the shield lumen <NUM> and a pilot surface <NUM>, which defines a pilot diameter <NUM>. The pilot diameter <NUM> is greater than the shield lumen diameter <NUM> and less than the first lumen diameter <NUM>. In the embodiment illustrated herein the pilot diameter <NUM> is also less than the shoulder diameter <NUM> to provide a limit stop for engagement with the distal tube end <NUM>. However, other configurations are contemplated where the shoulder diameter <NUM> and the pilot diameter <NUM> are equal such that the lumen apex <NUM> functions as the limit stop for engagement with the distal tube end <NUM>. The shield lumen <NUM> extends through the pilot member <NUM> into communication with the first lumen <NUM> such that the cutting accessory <NUM> can be inserted into the distal sleeve end <NUM>, through the shield lumen <NUM> and received by the tube <NUM> in the first lumen <NUM>.

The pilot member <NUM> is arranged with the annular profile protruding from the shoulder portion <NUM>, near the first lumen apex <NUM>, into the first lumen <NUM> such that the pilot surface <NUM> extends between the first lumen apex <NUM> and a proximal pilot end <NUM>. When the proximal pilot end <NUM> is received in the distal tube end <NUM> the pilot member <NUM> provides rigidity to the sleeve body <NUM> by urging the shield lumen <NUM> into alignment with the tube <NUM> of the rotary instrument <NUM>, which constrains movement of the working end <NUM>. In some configurations not forming part of the present invention the irrigation sleeve <NUM> may be constructed such that the shield extension <NUM> does not protrude into the first lumen <NUM>, i.e. does not have a pilot member <NUM>.

The location of the proximal reference <NUM> of the sleeve body <NUM> may vary between different configurations of the irrigation sleeve <NUM>. In one configuration the proximal reference <NUM> may be the position of the distal tube end <NUM> when the irrigation sleeve <NUM> is assembled to the rotary instrument <NUM> so that the shield length <NUM> may be determined relative to the distance that the cutting accessory <NUM> protrudes from the distal tube end <NUM>. Alternatively, the proximal reference <NUM> may be the position of a structural element of the irrigation sleeve <NUM> itself, such as the lumen apex <NUM>, the proximal pilot end <NUM>, the shoulder portion <NUM>, the proximal sleeve end <NUM>, and the like.

Alignment of the tube <NUM> within the first lumen <NUM> is facilitated by the transition region <NUM> of the first lumen <NUM>. When the tube <NUM> is inserted into the first lumen <NUM> the distal tube end <NUM> will engage the inner surface <NUM> of the sleeve body <NUM>, which guides the distal tube end <NUM> toward the lumen apex <NUM> as the tube <NUM> is moved in a proximal to distal direction. In addition to the tapered shape of the transition region <NUM>, the proximal pilot end <NUM> may be tapered near the proximal pilot end <NUM> to further aid in alignment of the irrigation sleeve <NUM> on the rotary instrument <NUM>.

The sleeve body <NUM> may be manufactured from a transparent or semi-transparent material so as to promote visibility of the rotary instrument <NUM> during use. In one configuration, the sleeve body <NUM> is manufactured from a resilient, compliant, or otherwise expandable material, such as a soft plastic or rubber, to help the irrigation sleeve <NUM> conform to the shape of the tube <NUM> of the rotary instrument <NUM>. To this end, the first lumen <NUM> is advantageously sized and dimensioned to closely fit over the tube <NUM> of the rotary instrument <NUM>. Here, the inner surface <NUM> in the first lumen <NUM> may be provided with a non-slip or high coefficient of friction coating (for example, a co-extruded and tacky thermoplastic elastomer) to prevent inadvertent movement between the irrigation sleeve <NUM> and the tube <NUM> of the rotary instrument <NUM>. Conversely, the outer surface <NUM> of the sleeve body <NUM> may be provided with a smooth coating (for example, polytetrafluoroethylene), or may be covered with a water-activated lubricant, to help the irrigation sleeve <NUM> move towards the surgical site <NUM>. In one configuration, the sleeve body <NUM> is manufactured from a sterilizable material. The sleeve body <NUM> could be manufactured from any other suitable material or combination or materials.

In alternative or addition to the interference fit, the sleeve body <NUM> and the shield extension <NUM> may be bonded using an adhesive (not shown). The adhesive may be applied to a portion of at least one of the shoulder portion <NUM> and the transition region <NUM> of the first lumen <NUM> prior to insertion of the shield extension <NUM> into the sleeve body <NUM>. Different types of adhesive may be utilized depending on the materials chosen for both the shield extension <NUM> and the sleeve body <NUM>, for example, the adhesive may facilitate a mechanical bond by hardening to interlock each part and resist separation. Alternatively, the adhesive may facilitate a chemical bond between each part. Coupling of the sleeve body <NUM> and the shield extension <NUM> may be further accomplished by other bonding processes including, but not limited to, friction welding, ultrasonic welding, laser welding, heat staking, and the like.

In configurations where the irrigation sleeve <NUM> is constructed with a unitary, one-piece construction, whereby the sleeve body <NUM> and the shield extension <NUM> are formed in an integral manner, the sleeve body <NUM> and the shield extension <NUM> are formed from the same material. Here, the material chosen may be the same or similar material as described above in connection with either the sleeve body <NUM> of the shield extension <NUM>. Alternatively, other materials that combine properties of either of these materials may also be used. In another configuration the irrigation sleeve <NUM> may be formed using a co-molding process, in which the sleeve body <NUM> and the shield extension <NUM> are integrally formed from separate materials.

Referring again to <FIG>, each figure shows different exemplary combinations of elements of the surgical system <NUM>. Specifically, <FIG> shows the rotary instrument <NUM> fitted with a first irrigation sleeve 100A and a first cutting accessory 52A having a head 64A and a shank 66A. <FIG> shows the rotary instrument <NUM> fitted with a second irrigation sleeve 100B and a second cutting accessory 52B having a head 64B and a shank 66B. <FIG> shows the rotary instrument <NUM> fitted with a third irrigation sleeve 100C and a third cutting accessory 52C having a head 64C and a shank 66C.

As is shown in <FIG>, each of the cutting accessories 52A, 52B, 52C is different than the other and, as such, results in a different configuration of the surgical system <NUM>. Specifically, each cutting accessory 52A, 52B, 52C has a different length shank 66A, 66B, 66C. The first shank 66A is longer than both the second shank 66B and the third shank 66C, and the second shank 66B is longer than the third shank 66C. Said differently, the first shank 66A is the longest and the third shank 66C is the shortest. The length of each shank 66A, 66B, 66C is merely intended to illustrate one of many possible configurations of cutting accessories, which may have shank lengths that are longer and shorter than are shown here. The length of the shank may be selected based on the preferences of the surgeon or the particular surgical procedure that is being performed. Because the rotary instrument <NUM> shown between the figures is the same, the head 64A, 64B, 64C of each cutting accessory 52A, 52B, 52C protrudes from the distal tube end <NUM> at a distance that corresponds with the length of the shank 66A, 66B, 66C when assembled with the rotary instrument <NUM>.

In much the same way, the particular surgical procedure or the preferences of the surgeon may influence an exposed shank distance 190A, 190B, 190C that the head 64A, 64B, 64C of each cutting accessory 52A, 52B, 52C protrudes from the distal sleeve end <NUM>, i.e. how much of the shank 66A, 66B, 66C is exposed outside of the irrigation sleeve 100A, 100B, 100C. The exposed shank distance 190A, 190B, 190C is a function of the length of the shank 66A, 66B, 66C and the shield length 192A, 192B, 192C. Here, the first and second irrigation sleeves 100A, 100B both have the same shield length 192A, 192B, but the first shank 66A is longer than the second shank 66B, which results in the first cutting accessory 52A having a larger exposed shank distance 190A than the exposed shank distance 190B of the second cutting accessory 52B. Similarly, the third irrigation sleeve 100C has a shorter shield length 192C than either of the first and second irrigation sleeves 100A, 100B, and the shank 66C of the third cutting accessory 52C is shorter than the shank 66A, 66B of either the first and second cutting accessories 52A, 52B. As a result, the exposed shank distance 190C of the third cutting accessory 52C is shorter than the exposed shank distance 190A, 190B of either the first and second cutting accessories 52A, 52B. Specifically, the first exposed shank distance 190A of <FIG> is greater than both the second exposed shank distance 190B of <FIG> and the third exposed shank distance 190C of <FIG>, and the second exposed shank distance 190B is greater than the third exposed shank distance 190C. Said differently, the first exposed shank distance 190A is the longest and the third exposed shank distance 190C is the shortest.

As mentioned above, the particular surgical procedure or the preferences of the surgeon may influence the desired length of the shank <NUM> as well as the exposed shank distance <NUM>. In order to encompass the greatest number of shank length and exposed shank distances the irrigation sleeve <NUM> can be customized to suit the preferences of the surgeon or the availability of a particular cutting accessory <NUM>. Specifically, an irrigation sleeve <NUM> with a relatively long shield extension <NUM> is provided, which is capable of receiving a cutting accessory <NUM> with a shank <NUM> that is likewise relatively long, and providing a relatively short exposed shank distance <NUM>. The ability of the irrigation sleeve <NUM> to be customized shortening the shield extension <NUM> affords the irrigation sleeve <NUM> the capability of receiving a cutting accessory <NUM> having a relatively short shank <NUM>, which if used with a longer shield extension <NUM> would otherwise be too short to fully engage the rotary instrument <NUM>.

A method for customizing a surgical system <NUM> in connection with the irrigation sleeve <NUM> is provided. In <FIG>, the rotary instrument <NUM> having the tube extending to a distal tube end <NUM> is shown. The cutting accessory <NUM> is shown disengaged and spaced from both the irrigation sleeve <NUM> and the rotary instrument <NUM> along the longitudinal axis A1. The method comprises a step of providing the irrigation sleeve <NUM> having the sleeve body <NUM>, the lumen <NUM> formed in the sleeve body <NUM>, and the shield extension <NUM> having at least one length indicia <NUM> coupled to the sleeve body <NUM>.

The method further includes a step of coupling the irrigation sleeve <NUM> to the rotary instrument <NUM> such that at least a portion of the tube <NUM> is disposed in the lumen <NUM>. The irrigation sleeve <NUM> is slid over the tube <NUM> until the pilot member <NUM> is received in the distal tube end <NUM>. In this embodiment the irrigation sleeve <NUM> is provided separately from the rotary instrument <NUM>. Alternatively, the irrigation sleeve <NUM> may be provided installed on the rotary instrument <NUM>, as will be discussed in further detail below. In this step the method may further comprise a step of fluidly coupling the irrigation lumen <NUM> to the irrigation source <NUM>. Fluidly coupling the irrigation lumen <NUM> to the irrigation source <NUM> may be accomplished by coupling the feeder tube <NUM> to the line <NUM> via the connector, by inserting the feeder tube <NUM> into the irrigation lumen inlet <NUM>, by coupling a pre-assembled feeder tube <NUM> directly to the pump cassette <NUM>, and the like.

In <FIG>, a close-up section view of the rotary instrument <NUM> with the irrigation sleeve <NUM> installed and the cutting accessory <NUM> spaced beneath the rotary instrument <NUM> in a position that corresponds to a fully installed position of the cutting accessory <NUM>. Here, in this view the shield length <NUM> is shown relative to the exposed shank distance <NUM> that would result from assembly of this surgical system <NUM>. It can be seen that the head <NUM> would limit insertion of the cutting accessory <NUM> into the tube <NUM>. Said differently, the shank <NUM> of the cutting accessory <NUM> is too short to fully engage the rotary instrument <NUM> due to interference between the head <NUM> and the shield extension <NUM>.

In order to assemble the surgical system <NUM>, the method further comprises a step of severing the shield extension <NUM> at one of the at least one length indicia <NUM>, as shown in <FIG>. Here, one of the frangible segments <NUM> has been removed from the distal shield portion <NUM> and is spaced from the irrigation sleeve <NUM>. The frangible segment <NUM> is shown in phantom prior to the step of severing the shield extension <NUM>.

An alternative method for customizing the surgical system <NUM> in connection with the irrigation sleeve <NUM> is also provided. The method comprises a step of providing the irrigation sleeve <NUM> comprising the sleeve body <NUM> having a plurality of weakened segments <NUM>, the lumen <NUM> formed in the sleeve body <NUM>, and the pilot member <NUM> disposed in the first lumen <NUM>. The method further comprises a step of sliding the sleeve body <NUM> over the rotary instrument <NUM> such that the tube <NUM> is received by the lumen <NUM>. A step of engaging the pilot member <NUM> with the distal tube end <NUM> ensures that the irrigation sleeve <NUM> is fully engaged with the tube <NUM>.

Best shown in <FIG>, the method further comprises a step of removing at least one of the weakened segments <NUM> from the sleeve body <NUM> such that when the cutting accessory <NUM> is rotatably supported by the tube <NUM> of the rotary instrument <NUM> the shank <NUM> engages the rotary instrument <NUM> and the head <NUM> is spaced from the lumen <NUM>. As mentioned above, the irrigation sleeve may be supplied installed on the rotary instrument <NUM> prior to removing one of the weakened segments <NUM>. In this way the step of providing the irrigation sleeve <NUM> and the step of sliding the sleeve body <NUM> over the rotary instrument <NUM> are combined to be performed prior to severing the shield extension <NUM>. However, in the event that the irrigation sleeve <NUM> is supplied separately from the rotary instrument <NUM> it should be appreciated that the step of inserting the tube <NUM> of the rotary instrument <NUM> into the lumen <NUM> can be performed before, as well as after, a step of severing the shield extension <NUM> using the weakened segments <NUM> at one of the length indicia <NUM> in order to remove one of the frangible segments <NUM>.

Best shown in <FIG>, the method further comprises a step of and inserting the cutting accessory <NUM> through the lumen <NUM> and engaging the shank <NUM> with the rotary instrument <NUM>. In <FIG> a close up section view of the cutting accessory <NUM> inserted through the lumen <NUM> with the head <NUM> arranged adjacent to the distal shield portion <NUM> is shown. The weakened segment <NUM> has been removed from the distal shield portion <NUM> and is spaced from the irrigation sleeve <NUM> showing where the head <NUM> of the cutting accessory <NUM> would otherwise interfere with the irrigation sleeve <NUM>.

Referring now to <FIG> and <FIG>, an alternative embodiment of the surgical system <NUM> is shown. This embodiment is similar to the first embodiment of the surgical system <NUM> described above in connection with <FIG>. As such, the components and structural features of this embodiment of the surgical system <NUM> that are the same as or that otherwise correspond to the first embodiment of the surgical system <NUM> are provided with the same reference numerals. While the specific differences between these embodiments will be described in detail, for the purposes of clarity and consistency, only certain structural features and components common between these embodiments will be discussed and depicted in the drawing(s) of the second embodiment of the surgical system <NUM>. Here, unless otherwise indicated, the above description of the first embodiment of the surgical system <NUM> may be incorporated by reference with respect to the second embodiment of the surgical system <NUM> without limitation. With this background in mind, the surgical system <NUM> comprises the rotary instrument <NUM>, the cutting accessory <NUM>, and the irrigation sleeve <NUM>, which is installed on the rotary instrument <NUM>. In comparison to the rotary instrument <NUM> shown in <FIG> and <FIG>, the rotary instrument of <FIG> and <FIG> comprises a tube <NUM> that is longer.

The irrigation sleeve <NUM> according to this embodiment is shown removed from the rotary instrument <NUM> and the cutting accessory <NUM> in <FIG> and <FIG>. Here both the first end <NUM> and the working end <NUM> of the irrigation sleeve <NUM> can be seen, showing the increased length of the sleeve body <NUM>. The increased length of the sleeve body <NUM> allows the first lumen <NUM> to be correspondingly increased in size to accommodate the longer tube <NUM>. It should be appreciated that different lengths of the proximal sleeve portion <NUM> and the distal sleeve portion <NUM> can be provided to suit different rotary instruments <NUM> within the scope of the present disclosure. Likewise, the lengths of the shield extension <NUM> and to the sleeve body <NUM> can be supplied in standard increments to facilitate customization of the irrigation sleeve <NUM> to lengths falling between each standard increment.

<FIG> show two alternative implementations of the irrigation lumen of the irrigation sleeve. In many respects, the irrigation sleeve <NUM>', <NUM>" may be similar to that previously described with like numerals (plus a prime or double prim symbol e.g. <NUM>' and <NUM>") corresponding to like components, and any disclosure common to the corresponding components may be considered omitted in the interest of brevity should not be construed as limiting. Specifically, <FIG> show a punched feature <NUM>' and <FIG> show a skived feature <NUM>".

As shown in <FIG>, the punched feature <NUM>' is arranged near the distal sleeve end <NUM>' of the sleeve body <NUM>' and extends through the sleeve body <NUM>' from the outer surface <NUM>' to the inner surface <NUM>'. The punched feature <NUM>' defines an outlet surface <NUM>' and the lumen outlet <NUM>', with the lumen outlet <NUM>' arranged on the outlet surface <NUM>'. The outlet surface <NUM>' is generally perpendicular to the fluid jet FJ (see <FIG>) such that fluid is directed out of the lumen outlet <NUM>' toward the desired location. The fluid jet FJ may be approximately parallel to the longitudinal axis A1 (see <FIG>) extending through the sleeve body <NUM>', as the case may be.

Similar to above and as shown in <FIG>, the skived feature <NUM>" is arranged near the distal sleeve end <NUM>" of the sleeve body <NUM>" and modifies the outer surface <NUM>" of the sleeve body <NUM>" by locally reducing a thickness of the sleeve body <NUM>" such that the outlet surface <NUM>" is defined adjacent to the outer surface <NUM>". The outlet surface <NUM>" is generally perpendicular to the fluid jet FJ (see <FIG>) such that fluid is directed out of the lumen outlet <NUM>" toward the desired location. The fluid jet FJ may be approximately parallel to the longitudinal axis A1 (see <FIG>) extending through the sleeve body <NUM>', as the case may be.

As discussed above, the term irrigation sleeve <NUM> refers to one type of instrument sleeve, which is capable of providing irrigation to a location near the surgical site.

Claim 1:
An irrigation sleeve (<NUM>, <NUM>', <NUM>") for use with a surgical system (<NUM>) comprising an irrigation source (<NUM>), a rotary instrument (<NUM>) having a tube (<NUM>) extending to a distal tube end (<NUM>), and a cutting accessory (<NUM>) having a head (<NUM>) and a shank (<NUM>) adapted to be rotatably supported by the tube (<NUM>) of the rotary instrument (<NUM>), the irrigation sleeve (<NUM>, <NUM>', <NUM>") comprising:
a sleeve body (<NUM>) extending between a proximal body portion (<NUM>) and a distal body portion (<NUM>);
a first lumen (<NUM>) formed in said sleeve body (<NUM>) for receiving at least a portion of the tube (<NUM>) of the rotary instrument (<NUM>);
a second lumen (<NUM>) formed in said sleeve body (<NUM>) and spaced out of fluid communication with said first lumen (<NUM>);
a shield extension (<NUM>) coupled to said sleeve body (<NUM>) and having a proximal shield portion (<NUM>) and a distal shield portion (<NUM>), said proximal shield portion (<NUM>) engaged with said distal body portion (<NUM>), said shield extension (<NUM>) adapted to minimize tissue wrap about the cutting accessory shank (<NUM>), wherein said shield extension (<NUM>) further comprises a pilot member (<NUM>) coupled to said proximal shield portion (<NUM>) and at least partially disposed in said first lumen (<NUM>) and configured for engagement with a portion of the tube (<NUM>); and
a third lumen (<NUM>) formed in said shield extension (<NUM>) and in communication with said first lumen (<NUM>).