Irrigation sleeve for use with a surgical system - Patent Application 20070122997

Abstract

To provide an irrigation sleeve for use with a surgical system.SOLUTION: The present disclosure also provides a method of manufacturing an irrigation sleeve (78). The method comprises forming a sleeve body (86) extending between a proximal sleeve end and a distal sleeve end (86S), the sleeve body (86) having a first lumen (88) and a second lumen (90) spaced from the first lumen (88), the second lumen (90) having a crescent-shaped profile. The method further comprises positioning a shaft into the second lumen (90) at the distal sleeve end (86S), and reforming the sleeve body (86) around the shaft adjacent to the distal sleeve end (86S) to differentiate the second lumen (90) into a distal lumen region (94) having a cylindrical profile defined by the shaft and a proximal lumen region (92) having the crescent-shaped profile.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application is a continuation of U.S. Provisional Patent Application No. 62 / 536,733, filed June 25, 2017. This application claims all priority and benefit of the same, the disclosure of which is incorporated herein by reference. , which are hereby incorporated in their entirety.

[0002] [Technical field] The disclosure herein relates generally to surgical systems, and more particularly to surgical systems. This disclosure also relates to an irrigation sleeve for use with a surgical system. The present invention relates to a method for manufacturing an irrigation sleeve for use in a surgical instrument. [Background technology]

[0003] Conventional medical procedures involve approaching, viewing, and treating a local surgical site. Surgical tools are used routinely to perform surgical procedures or to assist medical professionals in performing treatments. Some applications include high speed drills, rotary burrs, fenestrated shavers, etc. In some cases, heat and debris buildup at the surgical site is inevitable. Irrigation systems are typically used that include an irrigation source connected to an irrigator via a flexible line. Irrigators are typically used to facilitate attachment to surgical tools for simultaneous movement with the surgical tools. The irrigation system typically includes one or more clips or fasteners. A user input device is provided to control the flow of fluid from the irrigator to the surgical site during use. Use.

[0004] Traditional irrigation systems can cause dripping outside the irrigator during use. This dripping tends to cause fluid to pool on the rotary cutting tool, resulting in This will result in splashing at the surgical site. The endoscopes used in the procedure tend to be splashed with droplets. It will be appreciated that any flashback will obstruct the medical professional's view of the surgical site.

[0005] To reduce the splashing mentioned above, some systems are located near the irrigator. However, these surgical systems may have additional valves or user input controls. Systems are expensive, difficult to keep clean and / or sterile, and require extensive medical or surgical care. Other surgical systems tend to separate irrigation from surgical tools, complicating the preparation and execution of the procedure. By positioning the irrigator further away from the axis of rotation of the cutting accessory, for example, By moving the lens towards the center, splashing is reduced. This configuration increases the handling size of the surgical tool and exposes a larger surgical site. This is undesirable and may result in some medical and surgical procedures, e.g. For example, in conflict with medical and surgical procedures such as those used in connection with minimally invasive surgery. become. Summary of the Invention [Problem to be solved by the invention]

[0006] There are known in the art surgical irrigation systems that overcome the aforementioned drawbacks and are suitable for use in medical and surgical procedures. It can be used in conjunction with various types of surgical tools commonly used in surgical equipment, and is useful, functional, and and manufacturing costs while providing consistent and reliable irrigation during use. There is a need for a surgical irrigation system that can provide [Means for solving the problem]

[0007] The present disclosure provides an irrigation sleeve for use with a surgical system, the surgical system comprising: an irrigation sleeve; a rotating instrument having an injection source, a tube extending from a distal end of the tube, a head, and a having an extending shank and adapted to be rotatably supported by a tube of a rotary tool; and a cutting accessory attached to the sleeve. a sleeve body extending between a proximal end of the sleeve and a distal end of the sleeve; A sleeve body is formed within the sleeve body for receiving at least a portion of the tube of the rotary instrument. The head of the cutting accessory is disposed adjacent to the distal end of the sleeve. A second lumen is formed in the sleeve body, spaced apart from the proximal lumen. The proximal lumen region is adapted to be in fluid communication with an irrigation source. The distal lumen region extends from the lumen entrance adapted to the distal lumen to the lumen transition. the fluid extends from the cutting accessory to a lumen outlet positioned to direct the fluid adjacent the head of the cutting accessory. The proximal lumen area has a larger cross-sectional area at the lumen transition than the distal lumen area. The distal lumen region of the second lumen is not in fluid communication with the first lumen. They are far apart.

[0008] The present disclosure provides an irrigation sleeve for use with a surgical system, the surgical system comprising: an irrigation sleeve; a rotating instrument having an injection source, a tube extending from a distal end of the tube, a head, and a having an extending shank and adapted to be rotatably supported by a tube of a rotary tool; The present invention also provides an irrigation sleeve comprising an irrigation sleeve and a cutting accessory. a sleeve body extending between a proximal end of the sleeve and a distal end of the sleeve; A sleeve body is formed within the sleeve body for receiving at least a portion of the tube of the rotary instrument. The head of the cutting accessory is disposed adjacent to the distal end of the sleeve. A second lumen is formed in the sleeve body, spaced apart from the proximal lumen. The proximal lumen region is adapted to be in fluid communication with an irrigation source. The distal lumen region extends from the lumen entrance adapted to the distal lumen to the lumen transition. the fluid extends from the cutting accessory to a lumen outlet positioned to direct the fluid adjacent the head of the cutting accessory. The proximal lumen region has a generally crescent-shaped profile, and the distal lumen region is a three-dimensional lumen of the proximal lumen region. It has a contour that is different from the sun-lunate contour.

[0009] The present disclosure also provides a method of manufacturing an irrigation sleeve, the method comprising: forming a sleeve body extending between the distal end of the sleeve and the distal end of the sleeve body; has a first lumen and a second lumen spaced from the first lumen, the second lumen being crescent-shaped This direction is such that the shaft at the distal end of the sleeve is The sleeve body is placed in the second lumen and the portion of the sleeve body adjacent to the distal end of the sleeve is placed around the shaft. The second lumen is reshaped into a distal lumen region having a cylindrical contour defined by the shaft. and a proximal luminal region having a crescent-shaped contour.

[0010] Other features and advantages of the present disclosure will become apparent from the following description taken in conjunction with the accompanying drawings. Once understood, it will become readily apparent. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic diagram illustrating a surgical system including a console, an irrigation source, and a rotating instrument having a cutting accessory, with an irrigation sleeve assembly according to one embodiment coupled to the rotating instrument and positioned in fluid communication with the irrigation source. [Figure 2] FIG. 2 is a partial right side view of the rotary instrument, cutting accessory, and irrigation sleeve assembly of FIG. 1 , showing a jet of fluid exiting the irrigation outlet of the irrigation sleeve assembly projecting near and beyond the cutting accessory toward an exemplary surgical site. [Figure 3] FIG. 3 is a partial perspective view of the rotary instrument, cutting accessory, and irrigation sleeve assembly of FIG. 2, showing a jet of fluid projected near and beyond the cutting accessory toward an exemplary surgical site consisting of a vertebra. [Figure 4] FIG. 4 is a perspective view of the rotating instrument, cutting accessory, and irrigation sleeve assembly of FIGS. 1-3. [Figure 5] FIG. 5 is an exploded perspective view of the rotating instrument, cutting accessory, and irrigation sleeve assembly of FIG. 4. [Figure 6] 5 is a partially broken longitudinal cross-sectional view of the rotating instrument, cutting accessory, and irrigation sleeve assembly shown in FIG. 4. FIG. [Figure 7] FIG. 7 is a perspective view of one embodiment of the irrigation sleeve of the irrigation sleeve assembly shown in FIGS. 1-6. [Figure 8] FIG. 8 is an enlarged, partial perspective view of the irrigation sleeve of FIG. 7, including a first lumen and a second lumen, showing the second lumen (shown in phantom) having a distal lumen region and a proximal lumen region spaced apart from the first lumen. [Figure 9] FIG. 9 is a top view of the irrigation sleeve of FIGS. 7-8. [Figure 10] 10 is a cross-sectional slice taken along line 10-10 of FIG. 9. [Figure 11]FIG. 11 is a cross-sectional slice taken along line 11-11 of FIG. 9. [Figure 12] 12 is a cross-sectional slice view taken along line 12-12 of FIG. 9. [Figure 13] FIG. 11 is a cross-sectional view taken along line 11-11 of FIG. 9. [Figure 14] 14 is an enlarged partial cross-sectional view taken along the line 14 in FIG. 13. [Figure 15] Figure 15A is a partially exploded perspective view of a first mandrel assembly with a first mandrel spaced from a shaft, and Figure 15B is a perspective view of a second mandrel assembly. [Figure 16A] 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body with first and second lumens, showing in phantom the second lumen having a crescent-shaped profile; FIG. [Figure 16B] An enlarged partial perspective view of the distal end of a sleeve body having first and second lumens, with the second lumen shown in phantom lines having a proximal lumen region with a crescent-shaped contour and a distal lumen region with a cylindrical contour. [Figure 16C] FIG. 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body having first and second lumens, showing the sleeve distal end of the sleeve body having a tapered profile, with the second lumen shown in phantom lines having a proximal lumen region with a crescent-shaped profile and a distal lumen region with a cylindrical profile. [Figure 16D] FIG. 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body having first and second lumens, showing in phantom lines a second lumen having a proximal lumen region having a crescent-shaped profile and a distal lumen region having a cylindrical profile, and showing the sleeve distal end of the sleeve body having a tapered profile that is chamfer-cut to define a lumen outlet that is in fluid communication with the distal lumen region. [Figure 17] FIG. 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body having first and second lumens, showing in phantom lines a second lumen having a proximal lumen region having a crescent-shaped profile and a distal lumen region having a cylindrical profile, and showing the sleeve distal end of the sleeve body having a tapered profile sliced ​​to define a lumen outlet in fluid communication with the distal lumen region. [Figure 18] FIG. 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body having first and second lumens, showing in phantom lines a second lumen having a proximal lumen region having a crescent-shaped profile and a distal lumen region having a cylindrical profile, and showing the sleeve distal end of the sleeve body having a tapered profile drilled to define a lumen outlet in fluid communication with the distal lumen region. [Figure 19] FIG. 1 is an enlarged partial perspective view of a sleeve distal end of a sleeve body having first and second lumens, showing in phantom lines a second lumen having a proximal lumen region having a crescent-shaped profile and a distal lumen region having a cylindrical profile, and showing the sleeve distal end of the sleeve body having a generally flat profile that has been transected to define a lumen outlet positioned at the sleeve distal end so as to be in fluid communication with the distal lumen region. [Figure 20A] 15B is an enlarged partial cross-sectional view taken longitudinally through a first mandrel of the first mandrel assembly of FIG. 15A. FIG. [Figure 20B] 20B is another enlarged partial cross-sectional view of the first mandrel assembly of FIG. 20A supporting the sleeve distal end of the sleeve body shown in FIG. 16A. [Figure 20C] Another enlarged partial cross-sectional view of the first mandrel assembly and sleeve body of Figure 20B, showing the shaft of Figure 15A positioned through the insertion guide of the first mandrel assembly and into the second lumen of the sleeve body shown in Figure 16A. [Figure 20D] 16B is an enlarged partial cross-sectional view taken longitudinally through the second mandrel assembly of FIG. 15B, showing the second mandrel assembly supporting the distal end of the sleeve of the sleeve body shown in FIG. 16B. [Figure 20E] 20D showing the second mandrel assembly supporting the sleeve distal end of the sleeve body shown in FIG. 16C. FIG. [Figure 20F] FIG. 16E is an enlarged partial cross-sectional view of the sleeve distal end of the sleeve body shown in FIG. 16D. [Figure 21] FIG. 10 is a perspective view of another embodiment of an irrigation sleeve of the irrigation sleeve assembly of the surgical system. [Figure 22] An enlarged partial perspective view of the irrigation sleeve of Figure 21, comprising a first lumen and a second lumen, showing the second lumen (shown in phantom) comprising a distal lumen region and a proximal lumen region spaced apart from the first lumen. [Figure 23] FIG. 23 is a top view of the irrigation sleeve of FIGS. 21-22. [Figure 24] 24 is a cross-sectional slice view taken along line 24-24 of FIG. 23. [Figure 25] 25 is a cross-sectional slice view taken along line 25-25 of FIG. 23. [Figure 26] 26 is a cross-sectional slice view taken along line 26-26 of FIG. 23. [Figure 27] FIG. 25 is a cross-sectional view taken along line 25-25 of FIG. 23. [Figure 28] 28 is an enlarged partial cross-sectional view taken along the line 28 in FIG. 27. [Figure 29] FIG. 10 is a schematic diagram of a manufacturing system used to reshape a sleeve body having first and second lumens to differentiate the second lumen into a distal lumen region and a proximal lumen region, showing a first mandrel body rotatably supported about an axis. [Figure 30A] 30 is an enlarged partial perspective view of a first mandrel body of the manufacturing system of FIG. 29. [Figure 30B] FIG. 30B is another enlarged partial perspective view of the first mandrel body shown in FIG. 30A, further showing the sleeve body having first and second lumens and the first mandrel body extending within the first lumen of the sleeve body, with the second lumen shown in phantom having a crescent-shaped profile. [Figure 30C] 30C is another enlarged partial perspective view of the first mandrel body and sleeve body shown in FIG. 30B, showing the shaft disposed within the second lumen of the sleeve body. FIG. [Figure 30D] FIG. 30D is another enlarged partial perspective view of the first mandrel body, sleeve body, and shaft shown in FIG. 30C, further showing heat shrink tubing positioned around a portion of the sleeve body adjacent the sleeve distal end. [Figure 30E]FIG. 30E is another enlarged partial perspective view of the first mandrel body, sleeve body, shaft, and heat shrink tubing shown in FIG. 30D, shown rotating about an axis and subjected to localized heat. [Figure 30F] FIG. 30D is another enlarged partial perspective view of the first mandrel body, sleeve body, shaft, and heat shrink tubing shown in FIGS. 30E, illustrating the heat shrink tubing partially shrunk around the sleeve member in response to the application of localized heat. [Figure 30G] An enlarged, partial perspective view of the first mandrel body, sleeve body, and heat shrink tube of Figure 30F, showing in phantom lines a second lumen having a lumen waste region with a crescent-shaped contour, a proximal lumen region with a crescent-shaped contour, and a distal lumen region with a cylindrical contour. [Figure 30H] FIG. 30F is an enlarged, partial perspective view of the sleeve body of FIG. 30G showing a cylindrical distal lumen region disposed between the crescent-shaped lumen waste region and the crescent-shaped proximal lumen region. [Figure 30I] Another enlarged partial perspective view of the sleeve body of Figure 30H showing the sleeve distal end having a generally flat profile defined by a cross section of the sleeve body cut transversely along the cylindrical distal lumen region to define a lumen outlet positioned at the sleeve distal end so as to be in fluid communication with the distal lumen region. DETAILED DESCRIPTION OF THE INVENTION

[0012] Referring now to the drawings, in Figure 1 a surgical system is shown at 40. Like numbers refer to like parts throughout the several views. Surgical System 40 The surgical instrument generally comprises an irrigation system 42 and surgical tools 44, each of which is described below. Both the irrigation system 42 and the surgical tools 44 are controlled by a foot switch 48. A console 46 is used to control the Thus, both the irrigation system 42 and the surgical tools 44 can be configured in many different ways. By way of non-limiting example, the surgical tool 44 and the irrigation system The systems 42 may be independently controlled, for example, by separate consoles or input devices. .

[0013] Referring now to Figures 1-3, in the exemplary embodiment shown in these figures, a surgical tool 44 is embodied as a rotary tool 50, generally designated 52. Here, the cutting accessory 52 drives the surgical site S. Approach T and / or the surgical site ST (by removing tissue, bone, etc.) To this end, the cutting The accessory 52 is depicted as a bar throughout the drawings. However, those skilled in the art will recognize that For example, it will be appreciated that the cutting accessory 52 may be of many different types or configurations. By way of non-limiting example, cutting accessory 52 may be a drill, shaver, etc. Additionally, the exemplary surgical tool 44 shown herein may be implemented as a rotary instrument 50. Although the surgical tool 44 is embodied in a surgical instrument, those skilled in the art will recognize that the surgical tool 44 may be implemented using an irrigation system (described in more detail below). Any number of configurations controlled by any suitable method sufficient to cooperate with system 42 Many different forms of tools (including elements) can be used, such as, but not limited to, endoscopes, reciprocating It will be understood that it may also be configured as a tool or the like.

[0014] Rotational tool 50 generally comprises a coupling 56 and a motor 58 (shown diagrammatically in FIG. 1). The motor 58 generates a rotational torque, and the rotational torque is coupled to the housing 54. The coupling 56 is adapted to releasably secure the cutting accessory 52. This allows the cutting accessory 52 to rotate simultaneously with the motor 58. The device 50 further includes a tube generally designated 60. The tube 60 is The cutting accessory 52 extends from the housing 54 to the tube distal end 62. The head 64 and the shank 66 extend from the head 64. The shank 66 is rotatable. It is adapted to be rotatably supported by the tube 60 of the instrument 50 (shown in detail The rotary tool 50 is axially fixed to the rotary tool 50 via a (non-rotating) coupling 56. In the exemplary cutting accessory 52, the head 64 is embodied as a burr, as previously described. As such, it may be of any suitable type or configuration.

[0015] In the exemplary rotary instrument 50 shown herein, the motor 58 is connected to the console 46. powered by a wired connection to the footswitch, which is similarly electrically connected to the console 46. However, those skilled in the art will appreciate that the rotary tool 50 is controlled via the console. The motor 58 controlled by 46 may be wired or not, and may take many different forms. It will be appreciated that the rotating tool 50 may be configured in any suitable manner. It may be pneumatically powered or driven by a motor located within the console. Similarly, the foot switch 48 may be operated via the console 46 to control the speed of the motor 58. It is intended to be used for control, but other forms of user input are also possible. For example, buttons, switches, etc. that control the rotation of the motor 58 are located on the housing of the rotary tool 50. The console 46 may be operably attached to the footswitch 48. The rotation of the motor 58 may be controlled without going through the

[0016] Those skilled in the art will appreciate that the use of high speed drills, rotary burrs, fenestrated shavers, etc., can be used to perform surgical procedures. It will be understood that debris accumulation in the ST region will inevitably occur. The system 40 utilizes an irrigation system 42 to direct fluid toward the surgical site ST to loosen debris and Floating and / or moving, and then removing the debris (e.g., by suction) Additionally, an irrigation system 42 is provided to clear debris from the endoscope and to aid in the cutting action during the procedure. 4. The surgical tool 4 is cooled by the cutting accessory, preventing the accumulation of debris on the cutting accessory, etc. 4 may be used to ensure proper operation.

[0017] The irrigation system 42 of the surgical system 40 directs fluid from an irrigation source 68 toward the surgical site ST. In FIG. 1, irrigation source 68 includes a fluid reservoir 70. Fluid reservoir 70 contains a reservoir of saline in fluid communication with a motor-driven pump cassette 72. The pump cassette 72 is disposed in fluid communication with the line 74. Here, a pump cassette 72 operably attached to the console 46 is A foot switch 48 is provided to direct fluid from a fluid reservoir 70 to a line 74. The lines 74 are connected to an irrigation sleeve assembly generally designated 76. The irrigation sleeve assembly 76 is adapted to be removably attached to the , which directs fluid toward the surgical site ST, as described in more detail below. do.

[0018] Conventional irrigation systems 42 can be used in conjunction with many different types of surgical tools 44. It should be understood that the irrigation system 42 may therefore generally be configured to have a flow rate or pump It is adjustable in terms of speed, i.e., depending on the type of medical or surgical procedure, the surgical technique used, Depending on the particular configuration of the tool 44 and / or the preferences of the medical professional, the irrigation system 42 may be For example, by selecting a pump speed, the fluid can be supplied at a specific, adjustable flow rate. Those skilled in the art will appreciate that irrigation system 42 may be configured in a number of different ways. It will be understood that the irrigation system may be configured and / or controlled by The stem 42 may be controlled by a separate console as previously described. The pump cassette 72 is advantageously driven by an electric motor via the console 46. However, other configurations of irrigation source 68 are contemplated herein. For example, a fluid reservoir 70 may be connected to an irrigation source. Fluid transfer to the reed assembly 76 may be accomplished by a manual pump. The system 42 and / or surgical tool 44 may be utilized in connection with a medical and / or surgical procedure. It may be integrated with or cooperate with a suction system or other system, tool, etc. It should be understood that this may also be used.

[0019] 1 and 4-6, the illustrated irrigation sleeve assembly 76 includes an irrigation sleeve. The device is provided with a tube 78, a liquid supply tube 80, a connector 82, and an adhesive member 84. As will be apparent, the irrigation sleeve assembly 76 can be used with various types of surgical tools 44, irrigation sleeves, and The present invention is applicable to the medical system 42, surgical system 40, etc., and is a disposable, single-use product. may be configured as a washable and / or sterilizable multi-use product. Good too.

[0020] As will be described in more detail below, the irrigation sleeve 78 is attached to the tubing 60 of the rotary instrument 50. and in some configurations, a fluid jet FJ disconnecting accessory 52. configured to project near and beyond the head 64 toward the surgical site ST. To achieve this purpose, the liquid supply tube 80 is connected to the connector 8 2 and the irrigation sleeve 78, and the connector 82 is The pump is adapted to be attached to line 74 of the pump system 42. Fluid transferred by set 72 travels from irrigation source 68 through line 74 and delivery tubing 80. 7 through the irrigation sleeve 78, which is then irrigated as previously described and further described below. As will be described in detail below, a fluid jet FJ is projected.

[0021] The liquid delivery tube 80 can be bonded by many different methods, for example, UV bonding, adhesive bonding, reverse welding, etc. It is understood that the irrigation sleeve 78 and connector 82 can be connected by a The connector 82 is adapted to be releasably attached to the line 74 described above. However, other configurations are contemplated. For example, the delivery tube 80 may be of various lengths and may be used for irrigation. It is adapted to be attached directly to the source 68, pump cassette 72, valve connection, etc. The adhesive member 84 may be connected to the liquid supply tube 80 and may be used to hold the liquid supply tube 80 in place during use. It is configured to be secured to the housing 54 of the rotary tool 50 (see FIG. 5; however, adhesive (Not shown in detail). Additionally, the irrigation sleeve assembly 76 is adapted for use with the present disclosure. It should be understood that irrigation sleeves 78 having various styles, lengths, configurations, etc. may be used. By way of non-limiting example, the embodiment of irrigation sleeve 78 shown in FIGS. 1-14 generally comprises: Irrigation sleeve 7, shown in FIGS. 21-28, has a "tapered" distal profile. The eighth embodiment has a generally "flat" distal profile. The specific differences are described in more detail below.

[0022] 1-14 and 21-28, an illustrative embodiment of the irrigation sleeve 78 is shown. The configuration is adapted to be coupled to the tube 60 of the rotary instrument 50 as previously described. (See FIGS. 4-6.) To this end, in one embodiment, irrigation sleeve 78 The sleeve body 86 extends between a proximal sleeve end 86P and a distal sleeve end 86S. A first lumen 88 for receiving the tube 60 of the rotary instrument 50 is provided in the sleeve. The body 86 is formed so that the head 64 of the cutting accessory 52 is positioned at the distal end of the sleeve. It is located adjacent to 86S (see Figures 2, 3, and 6). As will be clear from the following explanation, The sleeve 78 is first placed around the tube of the rotary tool 50 and then the cutting actuator A second lumen 90 spaced from the first lumen 88 is also provided. , formed in the sleeve body 86. The second lumen 90 is connected to the first lumen 88 and the second lumen 90. The irrigation sleeve 90 is isolated from the first lumen 88 so that there is no fluid communication between the first lumen 88 and the irrigation sleeve 90. The illustrated embodiment of the tube 78 is a single tube having a first lumen 88 and a second lumen 90 formed therein. A sleeve body 86 is used.

[0023] 6, 8, and 22, the second lumen 90 of the sleeve body 86 is a proximal lumen region 92 and distal lumen region 94. As will be explained in more detail below, the distal lumen The cavity area 94 allows the fluid FJ to project consistently and reliably under many different operating conditions. In some configurations, the proximal lumen region 92 is configured differently to allow for better vascularization. , the distal lumen region 94 directs the fluid jet FJ away from the shank 66 of the cutting accessory. In some configurations, the distal lumen region 94 is adapted to facilitate the projection of a cutting To encourage the projection of the fluid jet FJ substantially parallel to the shank 66 of the accessory 52, It has become.

[0024] 6, 8, and 22, the proximal lumen region 92 includes a lumen entrance 96 (see FIG. 6). The lumen inlet 96 extends from the delivery tube 80 to the lumen transition 98. The distal lumen region is adapted to be in fluid communication with an irrigation source 68 via the distal lumen region. 94 extends from a lumen transition 98 to a lumen outlet 100. The lumen outlet 100 is hereinafter referred to as a lumen outlet. As will be described in more detail, a plurality of cutting accessory members 52 may be provided to direct fluid adjacent to the head 64 of the cutting accessory 52. In some configurations, the lumen transition 98 defines a transition surface 102 (see FIG. 1). 3-14 and 27-28), the distal lumen region 94 is defined by a lumen exit 100 and a transition surface 110. 02. To this end, As best seen in FIG. 22, the distal lumen region 94 is defined by a transition surface 102. The distal lumen region 94 thus includes a transition inlet 104 and a lumen The first lumen 88 extends to provide fluid communication with the outlet 100. lumen 90, proximal luminal region 92, distal luminal region 94, luminal entrance 90, luminal transition 98, tube Each of the cavity outlet 100, transition surface 102, and transition inlet 90 are described in further detail below. Reveal.

[0025] The irrigation sleeve 78 may be made of a transparent or semi-transparent material to facilitate visibility of the rotary instrument 50 during use. In one configuration, the irrigation sleeve 78 is made of a transparent material. 78 to conform to the shape of the tube 60 of the rotary tool 50. The device is made of a flexible or expandable material, such as soft plastic or rubber. To that end, the first lumen 88 advantageously extends around the circumference of the tube 60 of the rotary instrument 50. Here, first lumen 88 is shaped and sized to fit more closely. The inner surface of the irrigation sleeve 78 prevents accidental movement between the irrigation sleeve 78 and the tubing 60 of the rotating instrument 50. To prevent this, anti-slip coatings or high coefficient of friction coatings (e.g., co-extruded adhesive thermal Conversely, the outer surface of the irrigation sleeve 78 may be provided with an irrigation coating. NOTE: To facilitate movement of the sleeve 78 toward the surgical site ST, a lubricious coating (e.g., For example, a coating of polytetrafluoroethylene may be provided, or the coating may be coated with a water-soluble lubricant. In one configuration, the irrigation sleeve 78 is made from a sterile material. However, one skilled in the art will appreciate that the irrigation sleeve 78 may be made of any material or combination of materials. It will be understood that the same may be made from

[0026] As previously mentioned, the lumen inlet 96 of the irrigation sleeve 78 is adapted to be in fluid communication with the irrigation source 68. To this end, as shown in FIG. 6, the lumen entrance 96 is , which is disposed adjacent to the sleeve proximal end 86P of the sleeve body 86 and is connected to the liquid delivery tube 80. Here, the irrigation sleeve 78 is connected to a tube receiving portion generally designated 106. The tube receiver 106 is located distal to the delivery tube 80 and the second lumen 90. 1. The lumen region 94 receives a portion of the delivery tube 80 to facilitate fluid communication between the lumen region 94 and the In the irrigation sleeve 78 shown throughout the drawings, The tube receiver 106 is, for example, a part of the proximal lumen region 92 of the second lumen 90 (sleeve body 86) adjacent to the proximal sleeve end 86P of the sleeve body 8 6 (see Figures 9-12 and 23-26). For example, the lumen inlet 96 provides fluid communication between the irrigation source 68 and the second lumen 90 of the irrigation sleeve 78. It is understood that the present invention may be formed in any suitable manner sufficient to facilitate Additionally, the irrigation sleeve 78 shown here has a single proximal lumen region 92 and a single 1. The distal lumen region 94 of the single second lumen 90 has a plurality of proximal lumens. It will be appreciated that region 92 may be arranged to connect with a single distal lumen region 94. Similarly, a single proximal lumen region 92 may be configured to communicate with multiple distal lumen regions 94. Additionally, it should be appreciated that multiple second lumens 90 may be utilized.

[0027] 9-14 and 23-28, the direction of the first lumen 88 is 10-13 and 24-27), and the proximal portion of the second lumen 90 The direction of the side lumen region 92 is generally in the direction of the second lumen passage 92 away from the first lumen passage 108. (See FIGS. 11 and 25.) A representative example of the irrigation sleeve 78 shown in these figures is shown in FIG. In one embodiment, the first lumen passage 108 and the second lumen passage 110 are both straight. The second lumen passage 110 is radially spaced from the first lumen passage 108 and is 108. This arrangement allows for a generally straight cylindrical profile throughout the drawing. This is compatible with the configuration of the tube 60 of the rotary tool 50 shown as having As mentioned, the rotary tool 50 may be configured in many different forms and therefore may be used in a variety of applications. Tubes 60 having any shape, configuration, contour, etc. may be used. The tube may have a curved cylindrical profile, in which case the first lumen passage 108 and the second lumen The channel 110 may be non-linear (curved) to match the contour of the tube. In this example, the first lumen passage 108 and the second lumen passage 110 are also spaced apart from each other. However, regardless of the particular configuration of tube 60, those skilled in the art will recognize that The first lumen passage 108 and the second lumen passage 110 may be configured in any suitable manner. , located, or defined.

[0028] 9-14 and 23-28, in one configuration, the second lumen 90 The direction of the distal lumen region 94 is generally aligned with the direction of the third lumen passage 112. The lumen passage 112, like the second lumen passage 110, is generally straight and extends from the first lumen passage 108. The first lumen passage 108 is radially spaced apart from the first lumen passage 108 and is aligned parallel to the first lumen passage 108. In this embodiment of the sleeve 78, the third lumen passage 112 is generally coincident with the second lumen passage 110. (See Figures 13-14.) However, the implementation of the irrigation sleeve 78 shown in Figures 21-28 In this configuration, the third lumen passage 112 is radially spaced from the second lumen passage 110 (see FIG. 27-28). Again, the third lumen passage 112 may be configured, arranged, and configured in many different configurations. It should be understood that the distance may be defined as a number.

[0029] In the illustrated embodiment of the irrigation sleeve 78 shown throughout the drawings, FIGS. As best shown in FIGS. 24-26, the first lumen 88 is connected to the tubing of the rotary instrument 50. 60. The first lumen 88 has a generally cylindrical profile that is complementary to the shape of the first lumen 80. Although shown as a fully cylindrical region, the first lumen 88 may be slotted. and / or may be configured with different shapes, contours, etc. For example, the first lumen 88 may receive a portion of the tube 60 of the rotating instrument 50. It should be understood that the shape may have any suitable contour sufficient to accommodate the shape.

[0030] In the embodiment of the irrigation sleeve 78 shown in FIGS. 7-14, the first lumen 88 ( The portion of body 86 adjacent sleeve distal end 86S has a generally tapered profile. The sleeve distal end 86S is complementary to the tube distal end 62 of the tube 60 of the rotary instrument 50. The distal end 62 of the tube is shaped to have a tapered, generally frustoconical profile, similar to that of the distal end 62 of the tube (FIG. 1- 6). In the embodiment of irrigation sleeve 78 shown in FIGS. 7-14, sleeve body 86 The distal end 86S of the sleeve is a lumen region 86S distal to the first lumen 88 and the second lumen 90. The lumen outlet 100 is formed by cutting both ends of the lumen 100 at an angle. The sleeve body 86 is disposed between the cavity transition portion 98 and the distal end 86S of the sleeve body 86. However, in the embodiment of the irrigation sleeve 78 shown in FIGS. 21-28, the sleeve body 86 The distal end 86S of the sleeve is in the distal lumen region 94 of the first lumen 88 and the second lumen 90. Both are cut transversely, so that the lumen outlet 100 is formed in the sleeve body 8 As described above, the sleeve body 86 may have other contours, shapes, etc. (see, for example, Figures 17-19).

[0031] In the embodiment of the irrigation sleeve 78 shown throughout the figures, the proximal portion of the second lumen 90 The side lumen region 92 has a generally crescent shape (see FIGS. 11 and 25) and is distal to the second lumen 90. Lumen region 94 has a generally cylindrical profile (see FIGS. 10 and 24). The crescent shape of region 92 directs fluid delivered to distal lumen region 94 along the length of sleeve body 86. the second lumen 90 of the irrigation sleeve 78 along the length of the It is configured to be efficiently positioned adjacent to the tube 60 of the rotary instrument 50. It should be appreciated that this configuration provides significant advantages in the overall size of the irrigation sleeve 78. However, those skilled in the art will appreciate that the proximal lumen region 92 provides a fluid path along the length of the sleeve body 86. The distal lumen region 94 may have a variety of shapes, configurations, etc. sufficient to guide the distal lumen region 94. Therefore, other proximal lumen region 92 contours, such as, but not limited to, , circular, polygonal, rectangular, etc. are also contemplated.

[0032] 8, 13-14, 22, 27-28, as previously mentioned, the lumen transition 98 , and defines a transition surface 102, and the distal lumen region 94 has a lumen exit 100 and a transition surface 102. 8 and 22. As best seen, the transition surface 102 is a generally flat surface that extends from the proximal end of the second lumen 90. It acts as a "step" between lumen region 92 and distal lumen region 94. However, the transition The surfaces 102 may be configured differently, for example, the proximal lumen region 92 and the distal lumen region It should be understood that the axial length may be configured as a "draft" tapering between 94. .

[0033] The outer periphery of the transition surface 102 is defined by the generally crescent contour of the proximal lumen region 92 of the second lumen 90. It should be understood that the periphery of the periphery is at least partially defined. More specifically, the periphery of the periphery shown in FIGS. As shown, the proximal lumen region 92 of the second lumen 90 has a first lumen corner surface 114, a second lumen corner surface 115, and a The lumen has a contour including a lumen corner surface 116, a first arcuate surface 118, and a second arcuate surface 120. The first and second arcuate surfaces 118, 120 face each other and are spaced apart from each other by the first and second pipes. The irrigation sleeve 78 shown in FIGS. In this embodiment, the transition surface 102 is approximately aligned with the first lumen corner surface 114 of the proximal lumen region 92. The contours have a matching first transition corner surface 122. However, other arrangements (e.g. It should be understood that other arrangements (e.g., concentric arrangements) are also contemplated.

[0034] With particular reference to the embodiment of the irrigation sleeve 78 shown in FIG. 14, the transition surface 102 is a second lumen corner surface 116 of the proximal lumen region 92, similarly positioned to generally coincide with the second lumen corner surface 116 of the proximal lumen region 92; The contour further includes a transition corner surface 124. Again, other arrangements are contemplated. Furthermore, in this embodiment, the transition inlet 104 has a generally cylindrical profile, and the first transition The transition surface 102 is formed to be located between the corner surface 122 and the second transition corner surface 124. The transition entrance 104 is formed between the first and second transition corner faces 122, 124. Although shown schematically as equidistantly spaced, other configurations are contemplated.

[0035] With particular reference to the embodiment of the irrigation sleeve 78 shown in FIG. 28, the transition surface 102 is defined by a transition inlet 104 (again shown to have a generally cylindrical profile). The transition entrance 104 has a contour further comprising an entrance corner surface 126. The proximal lumen of the second lumen 90 is generally aligned with the entrance corner surface 126 of the first lumen 90. The second lumen corner surface 116 of the region 92 is positioned so as to be substantially coincident with the second lumen corner surface 116 of the region 92. It should be understood that other arrangements are possible.

[0036] As previously mentioned, the proximal lumen region 92 and the distal lumen region 94 of the second lumen 90 are To this end, in one embodiment, the proximal Lumen region 92 has a cross-sectional area greater than that of distal lumen region 94 at the cross-section of lumen transition 98. As will be clear from the following explanation, In the illustrated embodiment of the irrigation sleeve 78, the cross-sectional area of ​​the proximal lumen region 92 and the distal The cross-sectional area of ​​any of the lumen regions 94 does not vary substantially along the length of the sleeve body 86 . As previously mentioned, in the embodiment of the irrigation sleeve 78 shown in FIGS. 7-14 (as in this description), 10 and 11 show the cross-sectional area of ​​the distal lumen region 94 (see FIG. 10). ) and the cross-sectional area of ​​the proximal lumen region 92 (see FIG. 11 ). 10 and 11 are cross-sectional views of the distal portion of this embodiment adjacent the lumen transition 98. 13-14 show the cross-sectional area of ​​the lateral lumen region 94 and the cross-sectional area of ​​the proximal lumen region 92. 21-28. 24 and 25 (shown to the same scale for purposes of this illustration) are cross-sectional views of distal lumen region 94. 24) and the cross-sectional area of ​​the proximal lumen region 92 (see FIG. 25). In other words, Figures 24 and 25 each show cross-sections adjacent lumen transition 98 of this embodiment. 9A and 9B represent the cross-sectional areas of the distal lumen region 94 and the proximal lumen region 92 in the plane ( See also Figures 27-28).

[0037] In one configuration, the cross-sectional area of ​​the proximal lumen region 92 is 2 times larger than the cross-sectional area of ​​the distal lumen region 94. In one configuration, the cross-sectional area of ​​the proximal lumen region 92 is between 20 and 30 times larger than the cross-sectional area of ​​the distal lumen region 9 4. In one embodiment, the cross-sectional area of ​​the proximal lumen region 92 is , at least ten times larger than the cross-sectional area of ​​the distal lumen region 94 .

[0038] 9 and 23, the lumen transition 98 is located closer to the sleeve distal end than the sleeve proximal end 86P. In one configuration, the first distance 128 is located near the distal end 86S of the lumen. and the lumen transition 98, and a second distance 130 greater than the first distance 128 is defined between the It is defined between the lumen transition 98 and the lumen entrance 96 .

[0039] Those skilled in the art will appreciate that a relatively long flow path with a relatively small cross-sectional area can impede fluid flow. Furthermore, excessive resistance to fluid may lead to fluid being directed toward the surgeon's site ST. This will adversely affect the performance of the irrigation source 68. The difference in the contours, cross-sectional areas, and relative lengths of the lumen regions 94 causes the fluid to undergo significant pressure Flow along the proximal lumen region 92 toward the distal lumen region 94 without increasing At the same time, during use, the fluid jet FJ can be directed from the lumen outlet 100 to the cutting accessory 52. This ensures that the beam is projected near and beyond the head 64 (FIG. 2 -3). Furthermore, the above-described configuration of the irrigation sleeve 78 is suitable for minimally invasive surgery (e.g., surgical departments, such as in invasive spinal surgery, endoscopic surgery (e.g., endoscopic transnasal surgery), etc. It offers significant advantages for some medical and surgical procedures where irrigation of the ST region is difficult. I want you to understand that.

[0040] 2-3, as previously mentioned, the irrigation sleeve 78 advantageously provides an irrigation system for the surgical site S. It may be used to facilitate irrigation of T, for example, to irrigate bone BN. Advantageously, the bone (BN) is brought into contact with the fluid jet (FJ) before the burr head (64). Minimizing or preventing fluid splashing across the ST It should be understood that fluid splashing occurs when the fluid is The fluid is injected directly into the bar head 64 or by contact with the bar head 66. However, depending on the preference of the medical professional and the procedure being performed, several In some applications, the outer edge of the burr head 64 may be skinned. This can be done by adjusting the irrigation source 68 and / or rotating the irrigation sleeve 78 with the instrument 5 10 along the tube 60) to the burr head 64 This is achieved by adjusting the relative position and / or orientation of the 00.

[0041] The process for manufacturing the embodiment of irrigation sleeve 78 shown in FIGS. 7-14 will now be described with reference to FIG. 15. A-20F. Also, the irrigation sleeve shown in Figs. 21-28 A process for manufacturing an embodiment of tube 78 is disclosed and described in connection with Figures 29-30I. do.

[0042] Referring to Figures 15A-20F, a first mandrel assembly, generally designated 132, The first mandrel assembly 132 shown is a first The mandrel includes a mandrel body 134, an insertion guide 136, a collar 138, and a shaft 140. Here, the first mandrel body 134 extends from a collar 138 and 8 supports an insertion guide 136. The insertion guide 136 is a hollow tapered funnel ( The insertion guide 136 has a funnel-like shape and is configured to support a shaft 140 that passes through the insertion guide 136. A second mandrel assembly, generally designated 142, is shown in FIG. 15B. The second mandrel assembly 142 is a mandrel having a conical region 146. 16A-16D, the irrigation system described above in connection with FIGS. Embodiments of sleeve 78 are described in more detail below in conjunction with Figures 20A-20F. The invention is shown according to the primary and / or secondary manufacturing "steps."

[0043] In FIG. 16A, the first sleeve body 80A is partially shown. The sleeve body 86A of the first embodiment is similarly connected to the sleeve distal end 86S and the sleeve (not shown). The first lumen 88 and the second lumen 90 extend between the proximal end 86P. , are formed in the first sleeve body 86A and are spaced apart from each other. According to the exemplary embodiment shown here, the second lumen 90 is the first sleeve main Extending along the entire length of body 86A between sleeve distal end 86S and sleeve proximal end 86P However, as previously mentioned, other configurations of the second lumen 90 are also contemplated. Here, the first sleeve body 86A is advantageously formed by an extrusion manufacturing process. It should be understood that the irrigation sleeve 78 may be prepared by an extrusion manufacturing process. The first sleeve body 86A can be customized for a particular application without significantly increasing manufacturing costs. It can be easily adjusted.

[0044] 20A-20C, a cross section of a portion of first mandrel assembly 132 is shown. FIG. 20A shows the first mandrel body 1 of the first mandrel assembly 132. 34, insertion guide 136, and collar 138. FIG. 20B is a continuation of FIG. 20A. Here, the first sleeve body 86A is shown in its first The first mandrel body 134 is supported by a portion of the first mandrel body 134 positioned to extend through the lumen 88 of the first mandrel body 134. FIG. 20B shows the first mandrel assembly 132 abutting against the collar 138. Also shown is the sleeve distal end 86S of the sleeve body 88. Figure 20C is a step following Figure 20B. 1 shows a step in which the shaft 140 of the first mandrel 132 is inserted into the The first mandrel is inserted through the guide 136 and into the second lumen 90. The assembly 132 is designed to allow the shaft 140 to be positioned in many different configurations. It should be understood that the second lumen is configured as follows. Specifically, in this embodiment, The proximal lumen region 92 and the distal lumen region 94 of the tubular member 90 are generally aligned with each other ( 10 and 11; see FIG. 14), various arrangements, alignments, and configurations are possible. do.

[0045] As shown in FIG. 20C, the first sleeve body 86A is attached to the first mandrel assembly 1. After being positioned relative to the first sleeve body 86A, for example, local heat LH is applied to the sleeve of the first sleeve body 86A. The first sleeve body 86A is attached to the portion adjacent to the distal end 86S of the sleeve. 2 sleeve body 86B, where heat can be applied by various local heating devices, e.g. The adhesive may be applied using laser heating, a heat gun, etc. As the material is reformed into second sleeve body 86B, as described in more detail below, In order to apply hoop compression to the first sleeve body 86A, a heat shrinking A tube may be placed over the first sleeve body 86A. is best seen in FIG. 16B. The second sleeve 8 will now be described in connection with FIG. 20D. 6B will be explained in more detail.

[0046] Referring to FIG. 16B, the second sleeve body 86B is configured as follows: At least a portion of the distal end 86S of the tube is wrapped around the shaft 140 of the first mandrel 132. The second lumen 90 is then re-formed, thereby forming a cylindrical lumen defined by the shaft 140. The contoured distal lumen region 94 and the three-dimensional structure described in connection with the first sleeve body 86A. and a proximal luminal region 92 that maintains a lunate contour. At this point, the second sleeve body 86B is removed from the first mandrel body 134 and the shaft The second sleeve body 86B is then removed from the second lumen 90. 20D, the second mandrel body 1 of the second mandrel assembly 142 Supported by 44.

[0047] As shown in FIG. 20D, the second sleeve body 86B is attached to the second mandrel assembly 1 After being positioned relative to the second sleeve body 86B, the second sleeve body 86B may, for example, apply local heat LH to the first sleeve body 86B. The sleeve body 86B has a portion adjacent to the sleeve distal end 86S, and the sleeve distal end 86S is reshaped into a third sleeve body C by shrinking it around the conical region 146. (See FIG. 16C.) FIG. 20E shows the steps following FIG. 20D. Specifically, the third sleeve body 86C corresponds to a portion adjacent to the sleeve distal end 86S. The second mandrel assembly 142 is configured to define a tapered profile. At this point, the third slot is re-formed around the conical region 146 (see FIG. 16C). The sleeve body 86C is removed from the second mandrel body 144 and the fourth sleeve body 8 6D (see Figures 16D and 20F).

[0048] The fourth sleeve body 86D is configured to retain at least a portion of the reshaped sleeve distal end S. by defining, exposing, or otherwise removing to expose the lumen outlet 100 of the (Compare Figures 20E and 20F.) To achieve this goal, The distal end 86S of the sleeve is beveled (FIG. 16) to expose the lumen outlet 100. D), thin-slicing (see Figure 17), or drilling (see Figure 18), which results in A fourth sleeve body 86D may be defined. However, those skilled in the art will recognize that the lumen outlet 10 It will be understood that the 0 may be exposed by other methods. The irrigation sleeve 78 may be manufactured by any suitable method consistent with the foregoing description. It should be understood that the lumen exit 100 may be exposed. The sleeve body 86 is "cut straight" in a substantially perpendicular direction (or horizontal direction) to expose the 1 shows an embodiment of the present invention, other configurations are possible.

[0049] As previously mentioned, the process for manufacturing the embodiment of irrigation sleeve 78 shown in FIGS. 21-28 is The process is disclosed in connection with Figures 29-30I.

[0050] Referring now to Figure 29, a manufacturing system 148 is shown in schematic form. The system 148 generally includes a driver 150, a gear set 152, and an energy applicator 154. The driver 150 selectively generates a rotational torque and transmits the rotational torque to a gear. 152, thereby rotating the cylindrical first mandrel body 134 about the axis AX To this end, the driver 150 is , embodied by an electric motor, and the gear set 152 is a first mandrel centered on an axis This may be embodied by a plurality of reduction gears for adjusting the rotational speed of the main body 134. However, the driver 150, whether or not it uses the gear set 152, is a first mandrel. It will be appreciated that the roller body 134 may be configured in many different configurations sufficient to rotate. The energy applicator 154, also shown diagrammatically in FIG. a laser heater configured to generate LH and direct or apply the localized heat LH; It may be embodied as a heater gun, etc.

[0051] 30A-30I, the irrigation sleeve 78 previously described in connection with FIGS. 21-28 is Several steps of the process for manufacturing the embodiment are shown in sequence. In this case, a part of the substantially cylindrical first mandrel body 134 is driven by, for example, a driver 150. and arranged to rotate about axis AH by torque selectively generated by As shown in Figure 29.

[0052] In FIG. 30B, a first sleeve body 86A of the type previously described in connection with FIG. 16A is shown. Here, the first sleeve body 86A is similarly formed at the distal end of the sleeve. and a sleeve proximal end 86P (not shown) extending between the end 86S and the sleeve proximal end 86P. , 90 are pre-formed on the first sleeve body 86A. The second lumen 90 is similarly formed along the entire length of the first sleeve body, e.g., by an extrusion manufacturing process. The first sleeve body 86A has a crescent-shaped profile formed by a process. Position the first mandrel body 134 within the first lumen 88 of the first sleeve body 86A. The first mandrel body 134 is supported by the first mandrel body 134.

[0053] In FIG. 30C, the shaft is inserted into the second lumen 90 of the first sleeve body 86A. The shaft 140 is shown adjacent or abutting the first lumen corner surface 114. However, as previously mentioned, the shaft 140 is positioned within the second lumen 90. The shaft 140 effectively defines a distal lumen region 94 of the second lumen 9. 1. The second lumen 90 is positioned in the second lumen 90 in a manner other than by abutting against the first lumen corner surface 114 of the first lumen 90. Please understand that you can also decide.

[0054] In FIG. 30D, a heat shrink tube 15 is disposed around the first sleeve body 86A. As previously mentioned, the heat shrink tubing 156 is used to In response to application of localized heat LH by the applicator 154 (see FIG. 29), the first sleeve The main body 86A can be subjected to circumferential compression.

[0055] In FIG. 30E, the first mandrel body 134, the first sleeve body 86A, the shaft The connector 140 and the heat shrinkable tube 156 are, for example, driven by the driver 150 (see FIG. 30). They rotate almost simultaneously about the axis AX (compare Fig. 30E with Fig. 30D), while local heat LH is applied adjacent to the heat shrink tubing, thereby forming the first sleeve body 86A. The material reforms around the first mandrel body 134 and the shaft 140. Specifically, the heat shrink tube 156 is heated by rotation around the axis AX and application of local heat LH. "shrinks" and applies circumferential compression, resulting in this efficient and relatively uniform stress. The force distribution assists in the reformation of the first sleeve body 86A into the second sleeve body 86B. It will be extended.

[0056] In FIG. 30F, the rotation about the axis AX and the application of the local heat LH are terminated, and the second stage The rib body 86B is supported on the first mandrel body 134, and the shaft 140 is still The heat shrink tubing 156 is disposed within the second lumen 90 as a second sleeve. In FIG. 30G, shaft 14 is partially "constricted" around a portion of body 86B. 0 is taken out of the second lumen 90. The second lumen 90 has a proximal lumen having a crescent-shaped contour. a proximal lumen region 92 and a distal lumen having a cylindrical contour defined by the shaft 140; The distal portion of the endothelial septum is shown differentiated into a distal endothelial septum 94 and a distal endothelial septum 158. The side lumen region 94 is formed by the shrinkage of the heat shrink tubing 156 (due to exposure to the local heat LH). 156, effectively aligning with the portion of the heat shrink tubing 156 that is attached to the proximal lumen region 92. It is longitudinally disposed between the cavity waste area 158 .

[0057] In FIG. 30H, the second sleeve body 86B is removed from the first mandrel body 134. In FIG. 30I, the second sleeve 156 is removed. The body 86B includes a first lumen 88 and a second lumen 90 in a reshaped distal lumen region 94. The sleeve distal end 86S and the lumen outlet 11 are cut across the entire length of the sleeve. 00 is defined (compare FIG. 30I with FIG. 30H). As previously mentioned, in this embodiment The lumen outlet 100 is located at the sleeve distal end 86S.

[0058] The irrigation sleeve 78 of the irrigation sleeve assembly 76 thus manufactured is The embodiment allows for consistent and reliable irrigation of the surgical site ST under many different operating conditions. In particular, one skilled in the art will understand that when irrigation is desired (e.g., by activating a foot switch), In this case, the irrigation sleeve 78 passes adjacent to and through the head 64 of the cutting accessory 52. facilitating the projection of fluid in excess of the lumen outlet 100 while preventing excess fluid from being projected (e.g., The disconnection access point is activated when irrigation is terminated (e.g., by interrupting operation of foot switch 48). Preventing "splashing" of the sari 52 against the shank 66 Furthermore, the low profile of the irrigation sleeve 78 allows for easy access to, for example, surgical areas where irrigation is desired. Medical and / or surgical procedures where the ST area is small and difficult to access (e.g., nasal approach) It will be appreciated that this provides significant advantages to the surgical procedures associated with the surgical approach. If so, the irrigation sleeve 78 described herein can be used with many different types of surgical tools 44. , particularly in connection with surgical tools 44 used within a confined surgical site ST. and can be used with many different types of conventional irrigation systems 42. You will understand that it is adapted to be

[0059] The terms "include," "includes," and "including" are used interchangeably with "comprise" and "comprises." ", comprises, and compris" has the same meaning as the term "combined" Furthermore, the terms "first," "second," "third," etc. The term is used to refer to some structural features and structures for the purposes of clarity and consistent non-limiting illustration. It should be understood that the term "component" is used herein to distinguish between components.

[0060] We have examined several configuration examples above. However, these configurations examined here The examples are not intended to be exhaustive, i.e., to limit the invention to any particular form. The technical terms used are intended to be used in a manner that is more restrictive than limiting. Many modifications and revisions have been made in light of the above suggestions. and modifications are possible and the invention may be practiced otherwise than as specifically described. stomach.

[0061] The invention is intended to be defined in the independent claims, with particular features being set out in the dependent claims. The subject matter of a claim that is dependent on one independent claim is not related to the subject matter of another independent claim. It is also possible to implement it in this way.

[0062] The present disclosure further includes the following clauses, the specific features of which are disclosed in the sub-clause. The provisions are specifically implemented as described in more detail with reference to the preceding configuration examples and drawings. That's fine.

[0063] [Article I] An irrigation sleeve for use with a surgical system, the surgical system comprising an irrigation source and a catheter. A rotating instrument having a tube extending from a distal end thereof, a head and a sleeve extending from the head. a cutting tool having a shaft adapted to be rotatably supported by a tube of a rotary tool; an irrigation sleeve comprising: a sleeve body extending between a proximal sleeve end and a distal sleeve end; a sleeve body formed therein for receiving at least a portion of a tube of a rotary instrument; a first lumen having a cutting accessory head disposed adjacent the distal end of the sleeve; a first lumen disposed in the a second lumen formed within the sleeve body and spaced apart from the first lumen, The second lumen comprises a proximal lumen region and a distal lumen region, the proximal lumen region being a distal lumen extending from a lumen inlet adapted to be in fluid communication with an injection source to a lumen transition; The region is positioned to direct fluid from the lumen transition adjacent to the head of the cutting accessory. the proximal lumen region extends to a lumen outlet connected to the lumen transition portion, and the proximal lumen region extends to a lumen outlet connected to the lumen transition portion. a second lumen having a cross-sectional area greater than the distal lumen region; An irrigation sleeve comprising:

[0064] [Article II] The irrigation sleeve of clause I, wherein the first lumen has a generally cylindrical contour.

[0065] [Article III] Any of clauses I-II, wherein the proximal lumen region of the second lumen has a crescent-shaped profile. 1. The irrigation sleeve according to claim 1.

[0066] [Article IV] The distal lumen region of the second lumen differs from the crescent-shaped profile of the proximal lumen region. 10. The irrigation sleeve of any one of clauses I-III, having a profile:

[0067] [Article V] Any of clauses I-IV, wherein the distal lumen region of the second lumen has a cylindrical profile. 1. The irrigation sleeve according to claim 1.

[0068] [Article VI] the lumen outlet is disposed between the lumen transition and the sleeve distal end. The irrigation sleeve described in any one of the IV.

[0069] [Article VII] The lumen transition defines a transition surface, and the distal lumen region defines a transition surface between the lumen exit and the transition surface. The irrigation sleeve of any one of clauses I-VI, extending in fluid communication between the Boo.

[0070] [Article VIII] A first distance is defined between the lumen outlet and the lumen transition, and the first distance Clause I, wherein a second distance greater than or equal to the first distance is defined between the lumen transition and the lumen entrance. - The irrigation sleeve according to any one of claims 1 to 7.

[0071] [Article IX] The direction of the first lumen is generally aligned with the direction of the first lumen passage, and the direction of the second lumen is , generally aligned in a direction of a second lumen passage spaced from the first lumen passage, clauses I-VI 11. The irrigation sleeve according to any one of claims 1 to 10.

[0072] [Article X] The irrigation sleeve of clause IX, wherein the first lumen passage is straight.

[0073] [Article XI] Clauses IX-X, wherein the second lumen passage is radially spaced from the first lumen passage. 10. The irrigation sleeve according to claim 9, wherein the irrigation sleeve is a

[0074] [Article XII] Clauses IX-XI, wherein the second luminal passage is straight and parallel to the first luminal passage. 10. The irrigation sleeve according to claim 9, wherein the irrigation sleeve is a

[0075] [Article XIII] Clauses IX-X, wherein the direction of the first lumen passage is aligned with the direction of the second lumen passage. 11. The irrigation sleeve according to any one of claims 1 to 10.

[0076] [Article XIV] An irrigation sleeve for use with a surgical system, the surgical system comprising an irrigation source and a catheter. A rotating instrument having a tube extending from a distal end thereof, a head and a sleeve extending from the head. a cutting tool having a shaft adapted to be rotatably supported by a tube of a rotary tool; an irrigation sleeve comprising: a sleeve body extending between a proximal sleeve end and a distal sleeve end; a sleeve body formed therein for receiving at least a portion of a tube of a rotary instrument; a first lumen having a cutting accessory head disposed adjacent the distal end of the sleeve; a first lumen disposed in the a second lumen formed within the sleeve body and spaced apart from the first lumen, The second lumen comprises a proximal lumen region and a distal lumen region, the proximal lumen region being a distal lumen extending from a lumen inlet adapted to be in fluid communication with an injection source to a lumen transition; The region is positioned to direct fluid from the lumen transition adjacent to the head of the cutting accessory. the proximal lumen region has a crescent-shaped profile and the distal lumen region extends to a lumen outlet defined by a crescent-shaped profile. a second lumen having a contour different from the crescent contour of the proximal lumen region; An irrigation sleeve comprising:

[0077] [Article VX] The irrigation sleeve of clause XIV, wherein the first lumen has a generally cylindrical profile.

[0078] [Article XVI] The distal lumen region of the second lumen has a generally cylindrical profile. The irrigation sleeve according to any one of the preceding claims.

[0079] [Article XVII] The proximal lumen region of the second lumen is located at the lumen transition portion and is spaced apart from the distal lumen region in cross section. The method according to any one of clauses XIV-XVI, wherein the cross-sectional area is greater than the distal lumen area. Irrigation sleeve.

[0080] [Article XVIII] the lumen outlet is disposed between the lumen transition and the sleeve distal end. The irrigation sleeve of any one of paragraphs XIV-XVII.

[0081] [Article XIX] The lumen transition defines a transition surface, and the distal lumen region defines a transition surface between the lumen exit and the transition surface. 10. The method of claim 9, wherein the surface of the Irrigation sleeve.

[0082] [Article XX] A first distance is defined between the lumen outlet and the lumen transition, and the first distance Clause X, wherein a second distance greater than or equal to the first distance is defined between the lumen transition and the lumen entrance. IV-XIX.

[0083] [Article XXI] The direction of the first lumen is generally aligned with the direction of the first lumen passage, and the direction of the second lumen is , generally aligned in the direction of a second lumen passage spaced apart from the first lumen passage, clause XIV - An irrigation sleeve as described in any one of XX.

[0084] [Article XXII] The irrigation sleeve of clause XXI, wherein the first lumen passage is straight.

[0085] [Article XXIII] Clause XXI - wherein the second lumen passage is radially spaced from the first lumen passage. XXII. An irrigation sleeve according to any one of claims 1 to 11.

[0086] [Article XXIV] Clauses XXI-X, wherein the second lumen passage is straight and parallel to the first lumen passage. 11. The irrigation sleeve according to any one of claims 1 to 10.

[0087] [Article XXV] The first lumen passage is generally coincident with the second lumen passage. Any one of the irrigation sleeves described herein.

[0088] [Article XXVI] 1. A method of manufacturing an irrigation sleeve, comprising: forming a sleeve body extending between a sleeve proximal end and a sleeve distal end; The sleeve body has a first lumen and a second lumen spaced from the first lumen, The lumen of the two has a crescent-shaped contour, a step, and disposing a shaft within the second lumen at the distal end of the sleeve; A portion of the sleeve body adjacent the sleeve distal end is reformed around the shaft, and a second tube is inserted. The lumen has a distal lumen region defined by a shaft having a cylindrical contour and a distal lumen region defined by a shaft having a crescent-shaped contour. and a proximal luminal region corresponding to the endothelial cells; A method comprising:

[0089] [Article XXVII] a first mandrel assembly having an insertion guide configured to support the shaft; and preparing a supporting the sleeve body by a first mandrel assembly; placing the shaft within an insertion guide of a first mandrel assembly; The method of clause XXVI, further comprising:

[0090] [Article XXVIII] Clause XXV further comprising the step of removing the shaft from the distal lumen region of the second lumen. The method according to any one of I-XXVII.

[0091] [Article XXIX] Providing a second mandrel assembly having a conical region; supporting the sleeve body by a second mandrel assembly; At least a portion of the sleeve body adjacent to the sleeve distal end is attached to the second mandrel assembly. reshaping the image around a conical region of the image; The method of any one of clauses XXVI-XXXVIII, further comprising:

[0092] [Article XXX] At least a portion of the sleeve body adjacent to the distal end of the sleeve is removed to form a distal lumen region and The method of clause XXIX, further comprising defining a lumen outlet in fluid communication.

[0093] [Article XXXI] 1. A method of irrigating bone at a surgical site, comprising: a rotating instrument, a cutting accessory having a burr head, and a proximal sleeve end and a distal sleeve end providing an irrigation sleeve having a sleeve body extending between a first a lumen formed in the sleeve body, and a second lumen extending from the first lumen within the sleeve body; Steps formed at intervals; The rotating tool is inserted into the first lumen of the irrigation sleeve, and the burr head of the cutting accessory is inserted into the distal end of the sleeve. positioning the slit so that it extends beyond the distal end of the slit; engaging the bone with a burr head of a cutting accessory; Directing fluid through a second lumen of the irrigation sleeve, Fluid exiting the section adjacent the distal end of the burr passes near and beyond the burr head. Projected towards the bone, step and A method comprising:

Claims

1. A method of manufacturing an irrigation sleeve (78), comprising: forming a sleeve body (86) extending between a sleeve proximal end (86P) and a sleeve distal end (86S), the sleeve body (86) having a first lumen (88) and a second lumen (90) spaced from the first lumen (88), the second lumen (90) having a crescent-shaped profile; disposing a shaft (140) within the second lumen (90) at the sleeve distal end (86S); reshaping a portion of the sleeve body (86) adjacent the sleeve distal end (86S) around the shaft (140) to differentiate the second lumen (90) into a distal lumen region (94) having a cylindrical contour defined by the shaft (140) and a proximal lumen region (92) having a crescent-shaped contour; A method comprising:

2. providing a first mandrel assembly (132) having an insertion guide (136) configured to support said shaft (140); supporting the sleeve body (86) by the first mandrel assembly (132); placing the shaft (140) within the insertion guide (136) of the first mandrel assembly (132); The method of claim 1 further comprising:

3. The method of claim 1 or 2, further comprising the step of removing the shaft (140) from the distal lumen region (90) of the second lumen (90).

4. Providing a second mandrel assembly (142) having a conical region (146); supporting the sleeve body (86) by the second mandrel assembly (142); reforming at least a portion of the sleeve body (86) adjacent the sleeve distal end (86S) around the conical region (146) of the second mandrel assembly (142); The method of any one of claims 1-3, further comprising:

5. 5. The method of claim 4, further comprising removing at least a portion of the sleeve body adjacent the sleeve distal end to define a lumen outlet in fluid communication with the distal lumen region.

6. Providing a first mandrel assembly (132) having a first mandrel body (134); disposing the first mandrel body (134) within the first lumen (88) of the sleeve body (86); The method of any one of claims 1 to 5, further comprising:

7. Prior to the step of reforming the sleeve body (86), providing a heat shrink tube (156); placing the heat shrink tubing (156) around a portion of the sleeve body (86) adjacent the sleeve distal end (86S); The method of claim 6 , wherein

8. The method of claim 7, wherein the step of reforming the sleeve body (86) further comprises rotating the first mandrel assembly (132).

9. 9. The method of claim 7 or 8, wherein the step of reforming the sleeve body (86) further comprises co-rotating the sleeve body (86) and the heat shrink tubing (156) with the first mandrel assembly (132).

10. The method of any one of claims 1-9, wherein the step of reforming the sleeve body (86) further comprises rotating the sleeve body (86).

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