Patent Description:
The disclosure set forth herein relate, generally, to surgical systems and, more specifically, to irrigation sleeves for use with surgical systems. The disclosure also relates to methods of manufacturing irrigation sleeves for use with surgical systems.

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. In certain applications, such as those which involve the use of high-speed drills, rotating burs, open-window shavers, and the like necessarily results in the accumulation of heat and debris at the surgical site. Here, surgical systems employ irrigation systems which generally comprise an irrigation source connected to an irrigator via a flexible line. The irrigator typically employs one or more clips or fasteners to facilitate attachment to the surgical tool for concurrent movement. Irrigation systems also typically employ a user input to control the flow of fluid out of the irrigator fluid towards the surgical site during use. <CIT> discloses a shaver blade assembly useable in either an irrigation-only mode, an aspiration-only mode or an irrigation/aspiration mode. The shaver blade assembly has a stationary elongated outer tube and a movable (e.g. rotatable) elongated inner tube, both inner and outer tubes having hubs attached to their proximal ends for attachment to a handpiece which provides power to move the inner blade relative to the outer blade. The inner and outer tubes are provided with cutting windows at their distal tips and the relative movement between these cutting windows acts to cut tissue during surgical procedures. The outer tube is provided with a fluid inlet port at the proximal end of its tubular surface and a fluid adapter is selectively attachable to the outer tube so as to provide a means for introducing irrigating fluid into the fluid port. The adapter is integrally formed with sealing surfaces which obviate the need for O-rings and the like. A longitudinally extending irrigating channel is provided between the inlet fluid port at one end of the irrigating channel and the outlet fluid port at the distal end of the irrigating channel.

Conventional irrigation systems have a tendency to produce a dripping effect out of the irrigator during use, which causes fluid to accumulate on rotating cutting instruments, resulting in splashing at the surgical site. Here, there is a tendency for fluid to splash onto endoscopes used during the surgical procedure. It will be appreciated that splashing of the endoscope can obstruct the medical professional's view of the surgical site.

In order to mitigate the splashing effect described above, certain surgical systems may comprise additional valves or user input controls positioned close to the irrigator. However, these surgical systems tend to be expensive, difficult to clean and/or sterilize, and add complexity to preparing for and carrying out the medical or surgical procedure. Other surgical systems attempt to mitigate the splashing effect by positioning the irrigator further away from the surgical tool, for example by moving the irrigator away from the rotational axis of the cutting accessory. However, this arrangement adds handling bulk to the surgical tool and necessitates exposing a larger surgical site, which is undesirable and may be incompatible with certain medical and surgical procedures, such as those used in connection with minimally invasive surgery.

There remains a need in the art for a surgical irrigation system which overcomes the disadvantages mentioned above, which can be used in connection with different types of surgical tools used in a broad array of medical and surgical procedures, and which strikes a substantial balance between usability, functionality, and manufacturing cost while, at the same time, affording consistent and reliable irrigation in use.

The invention provides an irrigation sleeve according to claim <NUM>. Further embodiments of the invention are provided in the dependent claims.

The present disclosure also provides a method of manufacturing an irrigation sleeve. The method comprises forming a sleeve body between a proximal sleeve end and a distal sleeve end, the sleeve body having a first lumen and a second lumen spaced from the first lumen, the second lumen having a crescent-shaped profile. The method further comprises positioning a shaft into the second lumen at the distal sleeve end, and reforming the sleeve body around the shaft adjacent to the distal sleeve end to differentiate the second lumen into a distal lumen region having a cylindrical profile defined by the shaft and a proximal lumen region having the crescent-shaped profile.

Other features and advantages of the present disclosure will be readily appreciated, as the same becomes better understood, after reading the subsequent description taken in conjunction with the accompanying drawings.

With reference now to the drawings, wherein like numerals indicate like parts throughout the several views, a surgical system is shown at <NUM> in <FIG>. The surgical system <NUM> generally comprises an irrigation system <NUM> and a surgical tool <NUM>, each of which will be described in greater detail below. A console <NUM> is employed to control both the irrigation system <NUM> and the surgical tool <NUM> via a footswitch <NUM>. However, as will be appreciated from the subsequent description below, both the irrigation system <NUM> and the surgical tool <NUM> could be configured and/or controlled in a number of different ways. By way of non-limiting example, the surgical tool <NUM> and the irrigation system <NUM> could be controlled independently, such as by discrete consoles or input devices.

Referring now to <FIG>, in the representative embodiment illustrated herein, the surgical tool <NUM> is realized as a 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 and/or manipulating a surgical site ST 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. However, those having ordinary skill in the art will appreciate that the cutting accessory <NUM> could be of a number of different types or configurations. By way of non-limiting example, the cutting accessory <NUM> could be a drill, a shaver, and the like. Moreover, while the representative surgical tool <NUM> illustrated herein is realized as a rotary instrument <NUM>, those having ordinary skill in the art will appreciate that the surgical tool <NUM> could be configured in a number of different ways, including but not limited to an endoscope, a reciprocating tool, and the like, from any number of components controlled in any suitable way sufficient to cooperate with the irrigation system <NUM> as described in greater detail below.

The rotary instrument <NUM> generally comprises a housing <NUM> which supports a coupling <NUM> and a motor <NUM> therein (depicted schematically in <FIG>). The motor <NUM> generates rotational torque which is translated to the coupling <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 coupling <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 herein, 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, those having ordinary skill in the art will appreciate that the rotary instrument <NUM> could be configured in a number of different ways, 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, buttons, switches, and the like 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>.

Those having ordinary skill in the art will appreciate that 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 ST. Here, the surgical system <NUM> employs the irrigation system <NUM> to directs fluid towards the surgical site ST to loosen, float, and/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 <NUM> during procedures by clearing debris from endoscopes, cooling cutting accessories, preventing the accumulation of debris on cutting accessories, and the like.

The irrigation system <NUM> of the surgical system <NUM> is configured to direct fluid from an irrigation source <NUM> towards the surgical site ST. 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 ST as described in greater detail below in connection with <FIG>.

It will be appreciated that conventional irrigation systems <NUM> can be used in connection with a number of different types of surgical tools <NUM>. 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 <NUM> being used, and/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). Those having ordinary skill in the art will appreciate that irrigation systems <NUM> can be configured and/or 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 assembly <NUM> could be achieved via a manually-actuated pump. Furthermore, it will be appreciated that the irrigation system <NUM> and/or the surgical tool <NUM> could incorporate, or otherwise cooperate with, a suction system or other systems, tools, and the like utilized in connection with medical and/or surgical procedures.

Referring now to <FIG> and <FIG>, the illustrated irrigation sleeve assembly <NUM> comprises an irrigation sleeve <NUM>, a feeder tube <NUM>, a connector <NUM>, and an adhesive member <NUM>. As will be appreciated from the subsequent description below, the irrigation sleeve assembly <NUM> can accommodate different types of surgical tools <NUM>, irrigation systems <NUM>, surgical systems <NUM>, and the like, and may be configured as a disposable, single-use product may can be configured as a cleanable and/or serializable, multi-use product.

As is described in greater detail below, 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 ST (see <FIG>). To this end, 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> described above. 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 is described in greater detail below.

It will be appreciated that 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 (see <FIG>; adhesion not shown in detail). Furthermore, it will be appreciated that irrigation sleeve assembly <NUM> may employ irrigation sleeves <NUM> of different styles, lengths, configurations, and the like consistent with the present disclosure. By way of non-limiting example, the embodiment of the irrigation sleeve <NUM> illustrated in <FIG> has a generally "tapered" distal profile, and the embodiment of the irrigation sleeve <NUM> illustrated in <FIG> has a generally "flat" distal profile. The specific differences between the illustrated embodiments will be described in greater detail below.

Referring now to <FIG> and <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 (see <FIG>). To this end, in one configuration, the irrigation sleeve <NUM> comprises a sleeve body <NUM> which extends between a proximal sleeve end 86P and a distal sleeve end <NUM>. A first lumen <NUM> is formed in the sleeve body <NUM> for receiving 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 adjacent to the distal sleeve end <NUM> (see <FIG>, <FIG>, and <FIG>). 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>. A second 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 second lumen <NUM>. The illustrated embodiments of the irrigation sleeve <NUM> employ a unitary, one-piece sleeve body <NUM> in which with the first lumen <NUM> and the second lumen <NUM> are formed.

With reference to <FIG>, <FIG>, and <FIG>, the second lumen <NUM> of the sleeve body <NUM> comprises a proximal lumen region <NUM> and a distal lumen region <NUM>. As is described in greater detail below, the distal lumen region <NUM> is configured differently from the proximal lumen region <NUM> such that the fluid FJ is projected in a consistent and reliable fashion and under a number of different operating conditions. In certain configurations, the distal lumen region <NUM> promotes projecting the fluid jet FJ away from the shank <NUM> of the cutting accessory <NUM>. In certain configurations, the distal lumen region <NUM> promotes projecting the fluid jet FJ substantially parallel with the shank <NUM> of the cutting accessory <NUM>. Other configurations are contemplated herein.

With continued reference to <FIG>, <FIG>, and <FIG>, the proximal lumen region <NUM> extends from a lumen inlet <NUM> (see <FIG>) to a lumen transition <NUM>. The 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 distal lumen region <NUM> extends from the lumen transition <NUM> to a lumen outlet <NUM>. The lumen outlet <NUM> is arranged to direct fluid adjacent to the head <NUM> of the cutting accessory <NUM>, as described in greater detail below. In some configurations, the lumen transition <NUM> defines a transition surface <NUM> (see also <FIG> and <FIG>), and the distal lumen region <NUM> extends in fluid communication between the lumen outlet <NUM> and the transition surface <NUM>. To this end, and as is best shown in <FIG> and <FIG>, the distal lumen region <NUM> comprises a transition inlet <NUM> defined in the transition surface <NUM> such that the distal lumen region <NUM> extends in fluid communication between the transition inlet <NUM> and the lumen outlet <NUM>. The first lumen <NUM>, the second lumen <NUM>, the proximal lumen region <NUM>, the distal lumen region <NUM>, the lumen inlet <NUM>, the lumen transition <NUM>, the lumen outlet <NUM>, the transition surface <NUM>, and the transition inlet <NUM> will each be described in greater detail below.

The irrigation sleeve <NUM> may be manufactured from a transparent or semitransparent material so as to promote visibility of the rotary instrument <NUM> during use. In one configuration, the irrigation sleeve <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, an inner surface of 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 of the irrigation sleeve <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 ST. In one configuration, the irrigation sleeve <NUM> is manufactured from a sterilizable material. However, those having ordinary skill in the art will appreciate that the irrigation sleeve <NUM> could be manufactured from any suitable material or combination or materials.

As noted above, the lumen inlet <NUM> of irrigation sleeve <NUM> is adapted for fluid communication with the irrigation source <NUM>. To this end, as shown in <FIG>, the lumen inlet <NUM> is arranged adjacent to the proximal sleeve end 86P of the sleeve body <NUM> and is coupled to the feeder tube <NUM>. Here, the irrigation sleeve <NUM> is provided with a tube receptacle, generally indicated at <NUM>, which is shaped to receive a portion of the feeder tube <NUM> therein so as to facilitate fluid communication between the feeder tube <NUM> and the distal lumen region <NUM> of the second lumen <NUM>. In the irrigation sleeves <NUM> illustrated throughout the drawings, the tube receptacle <NUM> is formed integrally with the sleeve body <NUM> to define the lumen inlet <NUM>, such as by widening the proximal lumen region <NUM> of the second lumen <NUM> adjacent to the proximal sleeve end 86P of the sleeve body <NUM> (see <FIG> and <FIG>). However, those having ordinary skill in the art will appreciate that the lumen inlet <NUM> could be formed in any suitable way sufficient to facilitate fluid communication between the irrigation source <NUM> and the second lumen <NUM> of the irrigation sleeve <NUM>. Furthermore, while the irrigation sleeves <NUM> illustrated herein comprise a single second lumen <NUM> with a single proximal lumen region <NUM> and a single distal lumen region <NUM>, it will be appreciated that multiple proximal lumen regions <NUM> could be disposed in communication with a single distal lumen region <NUM>. Similarly, a single proximal lumen region <NUM> could be disposed in communication with multiple distal lumen regions <NUM>. Moreover, it will be appreciated that multiple second lumens <NUM> could be utilized.

Referring now to <FIG> and <FIG>, the first lumen <NUM> is aligned about a first lumen path <NUM> (see <FIG> and <FIG>), and the proximal lumen region <NUM> of the second lumen <NUM> is arranged about a second lumen path <NUM> (see <FIG> and <FIG>) spaced from the first lumen path <NUM>. In the representative embodiments of the irrigation sleeve <NUM> illustrated herein, the first lumen path <NUM> and the second lumen path <NUM> are both linear, and the second lumen path <NUM> is radially spaced from and is aligned in parallel fashion with the first lumen path <NUM>. This arrangement compliments the configuration of the tube <NUM> of the rotary instrument <NUM>, which is illustrated throughout the drawings as having a generally straight-cylindrical profile. However, as noted above, the rotary instrument <NUM> could be configured in a number of different ways and, thus, could employ tubes <NUM> with different shapes, configurations, profiles, and the like. By way of non-limiting example, the tube could have a curved, cylindrical profile, wherein the first lumen path <NUM> and the second lumen path <NUM> here would be non-linear (curved) so as to compliment the profile of the tube. Here too in this example, the first lumen path <NUM> and the second lumen path <NUM> could be spaced from and aligned with respect to each other. However, irrespective of the specific configuration of the tube <NUM>, those having ordinary skill in the art will appreciate that the first lumen path <NUM> and/or the second lumen path <NUM> could be arranged, disposed, or otherwise defined in any suitable way.

With continued reference to <FIG> and <FIG>, in one configuration, the distal lumen region <NUM> of the second lumen <NUM> is arranged about a third lumen path <NUM> which, like the second lumen path <NUM>, is generally linear and is radially spaced in parallel fashion from the first lumen path <NUM>. In the embodiment of the irrigation sleeve <NUM> illustrated in <FIG>, the third lumen path <NUM> is generally coincident with the second lumen path <NUM> (see <FIG>). However, in the embodiment of the irrigation sleeve <NUM> illustrated in <FIG>, the third lumen path <NUM> is radially spaced from the second lumen path <NUM> (see <FIG>). Here too, it will be appreciated that the third lumen path <NUM> may be arranged, disposed, or otherwise defined in a number of different ways.

In the illustrated embodiments of the irrigation sleeve <NUM> depicted throughout the drawings, and as is best shown in <FIG> and <FIG>, the first lumen <NUM> has a generally cylindrical profile which is complimentarily to the shape of the tube <NUM> of the rotary instrument <NUM>. While the first lumen <NUM> is illustrated with a closed, circular periphery (e.g., an unbroken cylindrical profile), it is conceivable that the first lumen <NUM> could be slotted and/or could be configured with a different shape, profile, and the like. Other configurations are contemplated, and it will be appreciated that the first lumen <NUM> could have any suitable profile sufficient to receive a portion of the tube <NUM> of the rotary instrument <NUM>.

In the embodiment of the irrigation sleeve <NUM> depicted in <FIG>, the first lumen <NUM> has a generally tapered profile adjacent to the distal sleeve end <NUM> of the sleeve body <NUM>, which is shaped complimentarily to the distal tube end <NUM> of the tube <NUM> of the rotary instrument <NUM>, which likewise has a tapered and generally frustoconical profile (see also <FIG>). In the embodiment of the irrigation sleeve <NUM> illustrated in <FIG>, the distal sleeve end <NUM> of the sleeve body <NUM> has been chamfer cut through both the first lumen <NUM> and the distal lumen region <NUM> of the second lumen <NUM> such that the lumen outlet <NUM> is arranged between the lumen transition <NUM> and the distal sleeve end <NUM> of the sleeve body <NUM>. However, in the embodiment of the irrigation sleeve <NUM> illustrated in <FIG>, the distal sleeve end <NUM> of the sleeve body <NUM> has been cut transversely through both the first lumen <NUM> and the distal lumen region <NUM> of the second lumen <NUM> such that the lumen outlet <NUM> is arranged at the distal sleeve end <NUM> of the sleeve body <NUM>. As noted above, the sleeve body <NUM> could have other profiles, configurations, and the like (see, for example, <FIG>).

In the embodiments of the irrigation sleeve <NUM> illustrated throughout the drawings, the proximal lumen region <NUM> of the second lumen <NUM> has a generally crescent-shaped profile (see <FIG> and <FIG>) and the distal lumen region <NUM> of the second lumen <NUM> has a generally cylindrical profile (see <FIG> and <FIG>). Here, the crescent-shaped profile of the proximal lumen region <NUM> is configured so as to accumulate fluid along the length of the sleeve body <NUM> to be provided to the distal lumen region <NUM> while, at the same time, efficiently positioning the fluid within the second lumen <NUM> of the irrigation sleeve <NUM> in close proximity to the tube <NUM> of the rotary instrument <NUM>. It will be appreciated that this configuration affords significant advantages to the overall size of the irrigation sleeve <NUM>. However, those having ordinary skill in the art will recognize that the proximal lumen region <NUM> could have different shapes, arrangements, and the like sufficient to direct fluid towards the distal lumen region <NUM> along the length of the sleeve body <NUM> and, thus, other proximal lumen region <NUM> profiles are contemplated, including but not limited to circular, polygonal, rectangular, and the like.

Referring now to <FIG>, <FIG>, <FIG>, and <FIG>, as noted above, the lumen transition <NUM> defines the transition surface <NUM> such that the distal lumen region <NUM> extends in fluid communication between the lumen outlet <NUM> and the transition inlet <NUM> defined in the transition surface <NUM>. As is best shown in <FIG> and <FIG>, the transition surface <NUM> is generally planar and acts as a "step" between the proximal lumen region <NUM> and the distal lumen region <NUM> of the second lumen <NUM>. However, it will be appreciated that the transition surface <NUM> could be configured differently, such as with a "draft," so as to taper between the proximal lumen region <NUM> and the distal lumen region <NUM>.

It will be appreciated that the outer periphery of the transition surface <NUM> is defined at least partially by the generally crescent-shaped profile of the the proximal lumen region <NUM> of the second lumen <NUM>. More specifically, as shown in <FIG> and <FIG>, the proximal lumen region <NUM> of the second lumen <NUM> has a profile comprising a first lumen corner surface <NUM>, a second lumen corner surface <NUM>, a first arc surface <NUM>, and a second arc surface <NUM>. The first and second arc surfaces <NUM>, <NUM> face towards each other and extend between the first and second lumen corner surfaces <NUM>, <NUM>. In the embodiments of the irrigation sleeve <NUM> depicted in <FIG> and <FIG>, the transition surface <NUM> has a profile comprising a first transition corner surface <NUM> which is arranged generally coincident with the first lumen corner surface <NUM> of the proximal lumen region <NUM>. However, it will be appreciated that other alignments are contemplated (e. g, concentric alignment).

Referring specifically to the embodiment of the irrigation sleeve <NUM> depicted in <FIG>, the transition surface <NUM> has a profile further comprising a second transition corner surface <NUM> which is similarly arranged so as to be generally coincident with the second lumen corner surface <NUM> of the proximal lumen region <NUM>. Here too, other alignments are contemplated. Furthermore, in this embodiment, the transition inlet <NUM> has a generally cylindrical profile and is formed in the transition surface <NUM> so as to be arranged between the first transition corner surface <NUM> and the second transition corner surface <NUM>. While the transition inlet <NUM> is generally illustrated as being disposed equidistantly between the first and second transition corner surfaces <NUM>, <NUM>, other configurations are contemplated.

Referring specifically to the embodiment of the irrigation sleeve <NUM> depicted in <FIG>, the transition surface <NUM> has a profile further comprising an inlet corner surface <NUM> defined by the transition inlet <NUM>, which is likewise illustrated with a generally cylindrical profile. Here, the transition inlet <NUM> is arranged so as to be generally coincident with the inlet corner surface <NUM> of the transition surface <NUM>, and also generally coincident with the second lumen corner surface <NUM> of the proximal lumen region <NUM> of the second lumen <NUM>. Here too, it will be appreciated that other alignments are contemplated.

As noted above, the proximal lumen region <NUM> and the distal lumen region <NUM> of the second lumen <NUM> are configured differently from each other. To this end, in one configuration, the proximal lumen region <NUM> has a larger cross sectional area than the distal lumen region <NUM> taken at the lumen transition <NUM> (see <FIG>, <FIG>, <FIG>, and <FIG>). As will be appreciated from the subsequent description below, neither the cross sectional area of the proximal lumen region <NUM> nor the cross sectional area of the distal lumen region <NUM> varies substantially along the respective length of the sleeve body <NUM> in the illustrated embodiment of the irrigation sleeve <NUM>. In light of the forgoing, for the embodiment of the irrigation sleeve <NUM> depicted in <FIG>, <FIG> (which are for the purposes of this description shown at the same scale) comparatively illustrate the cross sectional areas of the distal lumen region <NUM> (see <FIG>) and of the proximal lumen region <NUM> (see <FIG>). Put differently, <FIG> are representative of the cross sectional areas of the distal lumen region <NUM> and the proximal lumen region <NUM>, respectively, taken adjacent to the lumen transition <NUM> in this embodiment (see also <FIG>). Furthermore and similarly, for the embodiment of the irrigation sleeve <NUM> depicted in <FIG>, <FIG> (which are for the purposes of this description shown at the same scale) comparatively illustrate the cross sectional areas of the distal lumen region <NUM> (see <FIG>) and of the proximal lumen region <NUM> (see <FIG>). Put differently, <FIG> are representative of the cross sectional areas of the distal lumen region <NUM> and the proximal lumen region <NUM>, respectively, taken adjacent to the lumen transition <NUM> in this embodiment (see also <FIG>).

In one configuration, the cross sectional area of the proximal lumen region <NUM> is between two and twenty times larger than the larger than the cross sectional area of the distal lumen region <NUM>. In one configuration, the cross sectional area of the proximal lumen region <NUM> is between five and fifteen times larger than the larger than the cross sectional area of the distal lumen region <NUM>. In one configuration, the cross sectional area of the proximal lumen region <NUM> at least ten times larger than the cross sectional area of the distal lumen region <NUM>.

Referring now to <FIG> and <FIG>, the lumen transition <NUM> is arranged closer to the distal sleeve end <NUM> than to the proximal sleeve end 86P. In one configuration, a first distance <NUM> is defined between the lumen outlet <NUM> and the lumen transition <NUM>, and a second distance <NUM>, larger than the first distance <NUM>, is defined between the lumen transition <NUM> and the lumen inlet <NUM>.

Those having ordinary skill in the art will appreciate that relatively long fluid paths with relatively small cross sectional areas resist fluid flow. Moreover, too much resistance to flow can adversely impact the ability of the irrigation source <NUM> to direct fluid towards the surgical site ST. Here, because of the differences in the profiles, cross sectional areas, and relative lengths of the proximal lumen region <NUM> and the distal lumen region <NUM> described above, fluid can travel along the proximal lumen region <NUM> towards the distal lumen region <NUM> without significant pressure increase, while, at the same time, ensuring that the fluid jet FJ projects from the lumen outlet <NUM> to beyond and adjacent to the head <NUM> of the cutting accessory <NUM> during use (see <FIG>). Furthermore, it will be appreciated that the configuration of the irrigation sleeve <NUM> described above affords significant advantages for certain medical and surgical procedures where providing irrigation to the surgical site ST is otherwise difficult, such as in connection with minimally invasive surgical procedures (for example, minimally invasive spinal surgery), endoscopic surgical procedures (for example, endoscopic transnasal surgery), and the like.

Referring now to <FIG>, as noted above, the irrigation sleeve <NUM> can advantageously be used to promote irrigation of surgical sites ST, such as to irrigate bone BN. Here, it will be appreciated that contacting bone BN before the bur head <NUM> with the fluid jet FJ advantageously minimizes or otherwise prevents "splashing" of fluid across the surgical site ST which could otherwise be caused by fluid contacting the shank <NUM> of the cutting accessory <NUM>, or by fluid which projects directly towards the bur head <NUM>. However, depending on the preferences of the medical professional and the procedure being performed, it may be advantageous to "skim" the outer edge of the bur head <NUM> in certain applications, which can be achieved by adjusting the irrigation source <NUM> and/or by adjusting the relative position and/or orientation of the lumen outlet <NUM> relative to the bur head <NUM> by moving the irrigation sleeve <NUM> along the tube <NUM> of the rotary instrument <NUM>.

The process of manufacturing the embodiment of the irrigation sleeve <NUM> illustrated in <FIG> is disclosed and described below in connection with <FIG>, and the process of manufacturing the embodiment of the irrigation sleeve <NUM> illustrated in <FIG> is disclosed and described below in connection with <FIG>.

Referring now to <FIG>, a first mandrel assembly, generally indicated at <NUM>, is shown in <FIG>. The illustrated first mandrel assembly <NUM> comprises a first mandrel body <NUM>, an insertion guide <NUM>, a collar <NUM>, and a shaft <NUM>. Here, the first mandrel body <NUM> extends from the collar <NUM> which, in turn, supports the insertion guide <NUM>. The insertion guide <NUM> has a hollow, tapered, "funnel" configuration and is shaped to support the shaft <NUM> therethrough. In <FIG>, a second mandrel assembly, generally indicated at <NUM>, is shown comprising a second mandrel body <NUM> having a conical region <NUM>. In <FIG>, the embodiment of the irrigation sleeve <NUM> described above in connection with <FIG> is shown in progressive and/or alternative "steps" of manufacture, as described in greater detail below in connection with <FIG>.

In <FIG>, a first sleeve body 86A is shown partially. Here, the first sleeve body 86A likewise extends between the distal sleeve end <NUM> and proximal sleeve end 86P (not shown). Here, too, the first lumen <NUM> and the second lumen <NUM> are formed in the first sleeve body 86A and are spaced from each other. At this step of manufacturing, and according to the representative embodiment illustrated herein, the second lumen <NUM> has the crescent-shaped profile along the entire length of the first sleeve body 86A between the distal sleeve end <NUM> and the proximal sleeve end 86P. However, as noted above, other profiles of the second lumen <NUM> are contemplated. Here, it will be appreciated that the first sleeve body 86A can advantageously be provided via an extrusion manufacturing process, which allows the longitudinal length of the first sleeve body 86A (and, thus, of the irrigation sleeve <NUM>) to be easily adjusted for particular applications without a significant increase in manufacturing cost.

Referring now to <FIG>, portions of first mandrel assembly <NUM> are depicted in cross section. <FIG> shows the first mandrel body <NUM>, the insertion guide <NUM>, and the collar <NUM> of the first mandrel assembly <NUM>. <FIG> illustrates a progressive step continuing from <FIG>, and shows the first sleeve body 86A described above supported on a portion of the first mandrel body <NUM>, which is positioned so as to extend through the first lumen <NUM> of the first sleeve body 86A. <FIG> also shows the distal sleeve end <NUM> of the sleeve body <NUM> abutting the collar <NUM> of the first mandrel assembly <NUM>. <FIG> illustrates a progressive step continuing from <FIG>, and shows the shaft <NUM> of the first mandrel assembly <NUM> positioned extending through the insertion guide <NUM> and into the second lumen <NUM>. Here, it will be appreciated that the first mandrel assembly <NUM> can be configured so as to allow the shaft <NUM> to be aligned in a number of different ways. Specifically, while the proximal lumen region <NUM> and the distal lumen region <NUM> of the second lumen <NUM> are generally aligned with each other in this embodiment (compare <FIG>, see also <FIG>), different arrangements, alignments, and configurations are contemplated.

After the first sleeve body 86A has been positioned with respect to the first mandrel assembly <NUM> as illustrated in <FIG>, the first sleeve body 86A is reformed into a second sleeve body 86B, such as by applying localized heat LH to the first sleeve body 86A adjacent to the distal sleeve end <NUM>. Here, heat could be applied using various localized heating devices, such as laser heating, heat guns, and the like. As described in greater detail below in connection with <FIG>, heat-shrink tubing may be positioned over the first sleeve body 86A so as to apply hoop compression to the first sleeve body 86A as the material is reformed into the second sleeve body 86B. The second sleeve body 86B is best depicted in <FIG> and is described in greater detail below in connection with <FIG>.

As shown in <FIG>, the second sleeve body 86B is configured such that at least a portion of the distal sleeve end <NUM> has been reformed around the shaft <NUM> of the first mandrel assembly <NUM> so as to differentiate the second lumen <NUM> into the distal lumen region <NUM> having a cylindrical profile defined by the shaft <NUM>, and the proximal lumen region <NUM>, which retains the crescent-shaped profile described above in connection with the first sleeve body 86A. At this point, the second sleeve body 86B is removed from the first mandrel body <NUM>, the shaft <NUM> is removed from the second lumen <NUM>, and the second sleeve body 86B is then supported on the second mandrel body <NUM> of the second mandrel assembly <NUM>, as depicted in <FIG>.

After the second sleeve body 86B has been positioned with respect to the second mandrel assembly <NUM> as illustrated in <FIG>, the second sleeve body 86B is reformed into a third sleeve body 86C (see <FIG>), such as by applying localized heat LH to the second sleeve body 86B adjacent to the distal sleeve end <NUM> to "shrink" the distal sleeve end <NUM> around the conical region <NUM>. Specifically, <FIG> illustrates a progressive step continuing from <FIG>, and shows the third sleeve body 86C reformed around conical region <NUM> of the second mandrel assembly <NUM> so as to define a correspondingly-shaped tapered profile adjacent to the distal sleeve end <NUM> (see <FIG>). At this point, the third sleeve body 86C is removed from the second mandrel body <NUM> and is formed into a fourth sleeve body 86D (see <FIG> and <FIG>).

The fourth sleeve body 86D is formed by removing at least a portion of the reformed distal sleeve end <NUM> to define, expose, or otherwise reveal the lumen outlet <NUM> described above (compare <FIG> with <FIG>). To this end, the reformed distal sleeve end <NUM> can be chamfer cut (see <FIG>), skived (see <FIG>) or punched (see <FIG>) to expose the lumen outlet <NUM> so as to define the fourth sleeve body 86D. However, those having ordinary skill in the art will appreciate that the lumen outlet <NUM> can be exposed in other ways. Moreover, it will be appreciated that the irrigation sleeve <NUM> described herein can be manufactured in any suitable way consistent with the foregoing description. By way of non-limiting example, <FIG> depicts an embodiment of the sleeve body <NUM> which has been "flat cut" generally perpendicularly (or, "transversely" to expose the lumen outlet <NUM>. Other configurations are contemplated.

As noted above, the process of manufacturing the embodiment of the irrigation sleeve <NUM> illustrated in <FIG> is disclosed in connection with <FIG>.

Referring now to <FIG>, a manufacturing system <NUM> is depicted schematically. The manufacturing system <NUM> generally comprises a driver <NUM>, a gearset <NUM>, and an energy applicator <NUM>. The driver <NUM> is configured to selectively generate rotational torque which, in turn, is translated to the gearset <NUM> to rotate a cylindrical first mandrel body <NUM> about the axis AX. To this end, the driver <NUM> may be realized by an electric motor, and the gearset <NUM> may be a planetary gear reduction to adjust the rotational speed of the first mandrel body <NUM> about the axis. However, it will be appreciated that the driver <NUM> could be configured in a number of different ways sufficient to rotate the first mandrel body <NUM>, with or without the use of a gearset <NUM>. The energy applicator <NUM>, likewise depicted schematically in <FIG>, is configured to generate, direct, or otherwise apply localized heat LH, and may be realized as a laser heater, a heat gun, and the like.

Referring now to <FIG>, certain steps involved in the process of manufacturing the embodiment of the irrigation sleeve <NUM> depicted and described above in connection with <FIG> are shown sequentially. In <FIG>, a portion of the generally cylindrical first mandrel body <NUM> is shown arranged for rotation about the axis AX, such as via torque selectively generated by the driver <NUM> (see <FIG>).

In <FIG>, a portion of a first sleeve body 86A of the type described above in connection with <FIG> is shown. Here too, the first sleeve body 86A likewise extends between the distal sleeve end <NUM> and proximal sleeve end 86P (not shown), with the first and second lumens <NUM>, <NUM> pre-formed in the first sleeve body 86A. At this step of manufacturing, and the second lumen <NUM> similarly has the crescent-shaped profile along the entire length of the first sleeve body, provided such as via an extrusion manufacturing process. The first sleeve body 86A is supported by the first mandrel body <NUM> by positioning the first mandrel body <NUM> within the first lumen <NUM> of the first sleeve body 86A.

In <FIG>, the shaft <NUM> is shown inserted into the second lumen <NUM> of the first sleeve body 86A, and is positioned adjacent to or otherwise in abutment with the first lumen corner surface <NUM>. However, as noted above, because the shaft <NUM> effectively defines the distal lumen region <NUM> of the second lumen <NUM>, it will be appreciated that the shaft <NUM> could be positioned within the second lumen <NUM> in other ways besides in abutment with the first lumen corner surface <NUM> of the second lumen <NUM>.

In <FIG>, a section of heat-shrink tubing <NUM> is shown placed over the first sleeve body 86A. As noted above, heat-shrink tubing <NUM> allows for the application of hoop compression to the first sleeve body 86A in response to the application of localized heat LH, such as from the energy applicator <NUM> (see <FIG>).

In <FIG>, the first mandrel body <NUM>, the first sleeve body 86A, the shaft <NUM>, and the heat-shrink tubing <NUM> are shown rotating generally concurrently about the axis AX (compare <FIG> with <FIG>), such as via torque generated by the driver <NUM> (see <FIG>), while localized heat LH is applied adjacent to the heat-shrink tubing <NUM> to reform the material of the first sleeve body 86A around the first mandrel body <NUM> and the shaft <NUM>. More specifically, the rotation about the axis AX and the application of localized heat LH causes the heat-shrink tubing <NUM> to "shrink" and apply hoop compression, which helps reform the first sleeve body 86A into a second sleeve body 86B in an efficient and relatively evenly-distributed fashion.

In <FIG>, the rotation about the axis AX and the application of localized heat LH have ceased, and the second sleeve body 86B is shown supported on the first mandrel body <NUM>, with the shaft <NUM> still positioned within the second lumen <NUM>, and with the heat-shrink tubing <NUM> partially "shrunk" around a portion of the second sleeve body 86B. In <FIG>, the shaft <NUM> has been removed from the second lumen <NUM>, and the second lumen <NUM> has is shown as having been differentiated into the proximal lumen region <NUM> with the crescent-shaped profile, the distal lumen region <NUM> with the cylindrical profile defined by the shaft <NUM>, and scrap lumen region <NUM>. Here, the distal lumen region <NUM> effectively aligns with the portion of the "shrunk" heat-shrink tubing <NUM> that was exposed to localized heat LH, and is arranged longitudinally between the proximal lumen region <NUM> and the scrap lumen region <NUM>.

In <FIG>, the second sleeve body 86B is shown having been removed from the first mandrel body <NUM> and with the heat-shrink tubing <NUM> removed. In <FIG>, the second sleeve body 86B has been cut transversely through the first lumen <NUM> and a portion of the reformed distal lumen region <NUM> of the second lumen <NUM> to define the distal sleeve end <NUM> and the lumen outlet <NUM> (compare <FIG> with <FIG>). The lumen outlet <NUM> is arranged at the distal sleeve end <NUM> in this embodiment, as noted above.

In this way, the embodiments of the irrigation sleeves <NUM> of the irrigation sleeve assembly <NUM> described above allow for consistent, reliable irrigation of surgical sites ST, under a number of different operating conditions. Specifically, those having ordinary skill in the art will appreciate that the irrigation sleeves <NUM> facilitate fluid projection next to and beyond the head <NUM> of the cutting accessory <NUM> when irrigation is desired (such as by activating the footswitch <NUM>) and, at the same time, prevent excessive fluid from projecting out of the lumen outlet <NUM> and "splashing" against the shank <NUM> of the cutting accessory <NUM> when irrigation is ceased (such as by deactivating the footswitch <NUM>). Moreover, it will be appreciated that the low-profile of the irrigation sleeve <NUM> affords significant advantages in connection with medical and/or surgical procedures where irrigation is desirable but the surgical site ST is small, difficult to access, and the like (e.g., when used in connection with trans-nasal approaches). Furthermore, those having ordinary skill in the art will appreciate that the irrigation sleeves <NUM> described herein can be used in connection with a number of different types of surgical tools <NUM>, in particular those types of surgical tools <NUM> which are employed for use in confined surgical sites ST, and are adapted for use with a number of different types of conventional irrigation systems <NUM>.

It will be further appreciated that the terms "include," "includes," and "including" have the same meaning as the terms "comprise," "comprises," and "comprising. " Moreover, it will be appreciated that terms such as "first,""second,""third," and the like are used herein to differentiate certain structural features and components for the non-limiting, illustrative purposes of clarity and consistency.

Several configurations have been discussed in the foregoing description. However, the configurations discussed herein are not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.

Claim 1:
An irrigation sleeve (<NUM>) for use with a surgical system (<NUM>) comprising an irrigation source (<NUM>) and a surgical tool (<NUM>), the irrigation sleeve (<NUM>) comprising:
a sleeve body (<NUM>) extending between a proximal sleeve end (86P) and a distal sleeve end (<NUM>);
a first lumen (<NUM>) formed in the sleeve body (<NUM>) for receiving at least a portion of the surgical tool (<NUM>); and
a second lumen (<NUM>) formed in the sleeve body (<NUM>), spaced from the first lumen (<NUM>), and comprising a proximal lumen region (<NUM>) and a distal lumen region (<NUM>), the proximal lumen region (<NUM>) extending from a lumen inlet (<NUM>) adapted for fluid communication with the irrigation source (<NUM>) to a lumen transition (<NUM>), and the distal lumen region (<NUM>) extending from the lumen transition (<NUM>) to a lumen outlet (<NUM>), the proximal lumen region (<NUM>) having a larger cross-sectional area than the distal lumen region (<NUM>) taken at the lumen transition (<NUM>); and
wherein the distal lumen region (<NUM>) of the second lumen (<NUM>) is spaced out of fluid communication with the first lumen (<NUM>).