Ultrasonic surgical irrigation sleeve and related assembly

Abstract

To provide an ultrasonic surgical irrigation sleeve and a related assembly which are easily operated to a specific surgical site and can prevent the occurrence of a hot spot along an ultrasonic tip and the leakage of irrigation fluid.SOLUTION: An ultrasonic surgical instrument assembly includes an irrigation sleeve assembly defining a lumen, and an ultrasonic tip 40 at least partially disposed within the lumen of the irrigation sleeve 48. The irrigation sleeve assembly comprises a hub 46 and an irrigation sleeve coupled to the hub. The irrigation sleeve comprises an inner sheath 50 and an outer sheath 58, both extending distally from the hub. The outer sheath surrounds at least a portion of the inner sheath to define an irrigation channel between the outer and inner sheaths for delivering irrigation fluid to the surgical site. The distal end of the inner sheath extends beyond the distal end of the outer sheath. Each of the inner and outer sheaths is coupled to the hub by an annular sealing member that creates a fluid-tight seal with the hub.SELECTED DRAWING: Figure 4

Description

[Background technology]

[0001] When ultrasonic instruments are used to cut tissue, the buildup of heat and biological debris can may cause various undesirable effects, such as damage to the device and / or surrounding tissue, and impaired vision. To eliminate or reduce these undesirable effects, irrigation and Irrigation and suction systems can be used in conjunction with ultrasonic instruments. The stem is typically delivered to the surgical site along with the ultrasonic instrument, irrigating the surgical site and Contains a cooling irrigation fluid. A suction source draws excess fluid and biological debris from the surgical site. This can improve visibility. Summary of the Invention [Problem to be solved by the invention]

[0002] Existing ultrasound instruments utilize a series of sleeves that are placed over the ultrasound tip of the ultrasound instrument. It can be used to guide a central suction channel for irrigation fluid and suction. , such ultrasonic instruments may be difficult to maneuver to certain surgical sites; and and / or may cause hot spots along the ultrasonic tip. Prevents leakage of irrigation fluid Therefore, there is a need to address one or more of these challenges. in the art. [Means for solving the problem]

[0003] The ultrasonic surgical assembly includes an ultrasonic instrument having a proximal end and a distal end and a suction passage. The ultrasonic instrument also includes a housing having a proximal portion and a distal portion; a transducer disposed at least partially within the The ultrasonic surgical instrument includes a horn and an ultrasonic tip having a shaft coupled to the horn. The assembly further includes an irrigation sleeve assembly. a hub releasably coupled to a distal portion of the housing; and an irrigation sleeve coupled to the hub. The irrigation sleeve includes an inner sheath extending distally from the hub. a tube having a proximal end and an opposite distal end, the tube at least partially surrounding the shaft of the ultrasound tip; The outer sheath extends distally from the hub and defines a cavity. The outer sheath has a proximal end and a The outer sheath surrounds a portion of the inner sheath and has an opposite distal end. The distal end of the inner sheath extends beyond the distal end of the outer sheath, defining an irrigation channel between the inner sheath and the outer sheath. The irrigation channel is configured to deliver irrigation fluid to the surgical site.

[0004] The tool assembly includes an ultrasonic tip including a shaft, the shaft defining an aspiration passage. The tool assembly also includes an irrigation sleeve assembly. The yellowtail includes a hub and an irrigation sleeve coupled to the hub. The irrigation sleeve extends from the hub. a distally extending inner sheath having a proximal end and an opposite distal end; The inner sheath defines a lumen that at least partially surrounds the shaft of the ultrasound tip. The side sheath extends distally from the hub. The outer sheath has a proximal end and an opposite distal end. The outer sheath surrounds a portion of the inner sheath, forming an irrigation channel between the outer and inner sheaths. The distal end of the inner sheath extends beyond the distal end of the outer sheath. , configured to deliver irrigation fluid to the surgical site.

[0005] The irrigation sleeve assembly is used with the ultrasonic tip of an ultrasonic instrument. The tube assembly includes a hub configured to be releasably coupled to an ultrasonic instrument. The irrigation sleeve assembly also includes an irrigation sleeve coupled to the hub. The catheter includes an inner sheath extending distally from a hub. The inner sheath has a proximal end and an opposite distal end. The inner sheath is configured to at least partially surround the ultrasound tip. The outer sheath defines a lumen. The outer sheath extends distally from the hub. The outer sheath has a proximal end and a The outer sheath surrounds a portion of the inner sheath and has an opposite distal end. The irrigation channel is configured to define an irrigation channel between the surgical site and the surgical base. The irrigation channel delivers irrigation fluid to the surgical site. The annular sealing member surrounds at least a portion of the hub and the outer sheath. The annular sealing member is configured to prevent fluid from exiting the hub and outer sheath. can be.

[0006] These and other examples, configurations, features, and advantages of the present disclosure will be apparent to those skilled in the art. The present disclosure is not limited to these examples, configurations, features, and advantages.

[0007] Benefits of the present disclosure may be obtained by reference to the following detailed description when considered in conjunction with the accompanying drawings. It will be readily understood that the same will be better understood by [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of an ultrasonic surgical assembly. [Figure 2] FIG. 1 is a cross-sectional view of an ultrasonic surgical assembly. [Figure 3] FIG. 1 is a partially exploded perspective view of an ultrasonic instrument and an irrigation sleeve assembly. [Figure 4] FIG. 10 is an exploded view of the irrigation sleeve assembly, ultrasonic tip, and annular sealing member. [Figure 5] FIG. 10 is a cross-sectional view of the irrigation sleeve assembly, ultrasonic tip, and annular sealing member. [Figure 6] 6 is a cross-sectional view of FIG. 5 taken along line 6-6. [Figure 7] 7 is a cross-sectional view of FIG. 5 taken along line 7-7. [Figure 8] 8 is a cross-sectional view of FIG. 5 taken along line 8-8. [Figure 9] 9 is a cross-sectional view of FIG. 5 taken along line 9-9. [Figure 10] 1A-1C are detailed perspective and cross-sectional views of the irrigation sleeve assembly, ultrasonic tip, and annular sealing member. [Figure 11] FIG. 6 is a detailed view of the irrigation sleeve assembly including the ultrasound tip of FIG. 5 within circle 11. [Figure 12] FIG. 1 is a perspective view of one configuration of the hub. [Figure 13] FIG. 13 is a cross-sectional view of the hub of FIG. 12. [Figure 14] 2 is a schematic diagram of the ultrasonic surgical assembly of FIG. 1 including an irrigation sleeve and an ultrasonic tip inserted through an exemplary patient access portal defined by a dilator for spinal surgery. [Figure 15] FIG. 2 is a perspective view of the ultrasonic surgical assembly of FIG. 1 including an irrigation sleeve and ultrasonic tip inserted through an alternative exemplary patient access portal within a patient's skull for nasal surgery or neurosurgery. DETAILED DESCRIPTION OF THE INVENTION

[0009] Figures 1 and 2 show a surgical instrument that a surgeon or other user may use to remove / cut biological material from a patient. 1 shows an ultrasonic surgical assembly 20 that can be used for the proximal The ultrasonic instrument 22 has a tip 24, a distal end 26, and a suction passage 28. 2 includes a housing 30 including a proximal portion 32 and a distal portion 34, and a small a transducer 36 (see FIG. 2) at least partially positioned; 36 coupled to a horn 38 and an ultrasonic tip 4 for removing / cutting biological material from a patient. It has 0.

[0010] Referring to FIG. 2, the transducer 36 is at least partially contained within the housing 30. The transducer 36 includes one or more piezoelectric elements, a magnetostrictive element, and or a mechanism for providing a horn 38 and ultimately delivering the ultrasound to the surgical site via an ultrasound tip 40. and other suitable elements configured to generate mechanical energy.

[0011] The horn 38 may be at least partially disposed within the housing 30. The horn 38 may include: The horn 38 may include a distal end 74 and a proximal end 76. The horn 38 is coupled to the transducer 36. Horn 38 also includes a horn lumen extending from distal end 74 to proximal end 76 of horn 38. Horn lumen 78 may be configured to define a portion of suction passage 28. .

[0012] The ultrasound tip 40 may include a shaft 42 having a distal portion 82 and a proximal portion 84. The ultrasonic tip 40 also connects the proximal portion 84 of the shaft 42 to the distal end 74 of the horn 38. In combination, the horn 38 is in mechanical communication with the ultrasonic tip 40 by being positioned adjacent to the shaft 42. The distal end of the horn 38 may include a coupling mechanism 90 disposed at the distal portion 84. The coupling mechanism 90 may be 74. The ultrasonic tip 40 is threaded onto the horn 38 and tightened to the specified torque specifications. The cap 40 can be removably secured to the horn 38. The coupling mechanism 90 may be a quick connect, quarter turn fitting, or similar coupling mechanism. It is contemplated that the coupling mechanism 90 may be configured as a mechanism. It is contemplated that the ultrasonic transducer may be configured to be permanently secured to the horn 38. For example, The wave tip 40 may be bonded to the horn 38 by welding, epoxy, or similar methods. Alternatively, the ultrasonic tip 40 and horn 38 may be formed as a single component. It is also possible that...

[0013] The shaft 42 of the ultrasound tip 40 also includes a sleeve 84 extending from a proximal portion 84 to a distal portion 82. The shaft lumen 92 may be configured to define a longitudinal axis 94. They may be oriented generally parallel, but may also be formed into other shapes. The shaft lumen 92 of the ultrasonic tip 40 is configured to accommodate the ultrasonic tip 40 when the ultrasonic tip 40 is coupled to the horn 38. , which may be optionally configured to define a portion of the suction passage 28 in communication with the horn lumen 78 The suction passage 28 may be open at the distal portion 82 of the shaft 42. , may be configured to provide suction away from the surgical site. For example, using suction channel 28 This allows fluid and tissue to be drawn away from the distal portion 82 of the ultrasound tip 40. .

[0014] The shaft 42 may be made of a metal material such as titanium alloy or stainless steel, or a composite material depending on the application. The material may be made of non-metallic materials such as aluminum, nickel, nickel, nickel alloy, nickel alloys ... The ultrasound tip 40 may be integral, one-piece, and one-piece, but may also be of multiple constructions. The diameter of the distal portion 82 of the shaft 42 is such that it fits through a small opening in the patient's To function, it has a relatively small diameter, e.g., less than one centimeter (1 cm). It should be understood that shaft 42 may also be larger depending on the application. It should be understood that the present invention may be scaled smaller or larger.

[0015] As shown with reference to FIGS. 2, 3, and 4, the ultrasound tip 40 includes a transducer. The vibration energy transmitted from the sensor 36 is converted into a composite vibration consisting of longitudinal vibration and torsional vibration. The device may further include a vibration conversion mechanism 96 for converting the vibration into a vibration. For more information, see U.S. Patent No. 6,497,715, U.S. Patent No. 6,955,680, and U.S. Patent No. 6,984,220, which are incorporated herein by reference. The entire contents of which are incorporated herein.

[0016] The ultrasound tip 40 may be moved by torsional and / or longitudinal movement of the ultrasound tip 40. However, the ultrasonic tip 40 also has a longitudinal transducers that vibrate in a longitudinal direction, a torsional direction, a combination of these, or in other ways. It should be understood that the present invention may be used with the sensor 36. So there is no vibration conversion mechanism 96.

[0017] The ultrasound tip 40 is configured such that the distal portion 82 of the ultrasound tip 40 is aligned with the proximal portion of the ultrasound tip 40. The ultrasound tip 40 may have a bent portion 80 that bends relative to the ultrasound tip 40. The surgical assembly 20 may be configured to allow for better line of sight while in use. Additionally, in some surgical procedures, the bend 80 provides better access to the surgical site within the patient. The ultrasound tip 40 has a single bend 80 as shown. Other ultrasonic tip 40 configurations may include multiple bends or no bends. Shape is also considered.

[0018] As shown in FIG. 2, the housing 30 is disposed within the housing void 72. Alternatively, the irrigation lines 70 may be routed externally to the housing 30. 70 extends from the proximal portion 32 of the housing 30 to the distal portion 34 of the housing 30. Irrigation lines 70 may be configured to extend from an irrigation system coupled to ultrasonic instrument 22 to: It may function to direct fluid through the housing 30 to the irrigation sleeve assembly 44. An irrigation line 70 routes directly from an irrigation source (not shown) to the irrigation sleeve assembly 44. (i.e., irrigation lines do not necessarily have to be routed through the housing 30 Please understand that there is no need to

[0019] As shown with reference to FIGS. 2-5 and 10, the irrigation sleeve assembly 44 includes a housing. a hub 46 releasably coupled to the distal portion 34 of the housing 30; and an irrigation system coupled to the hub 46. The hub 46 may include a hub coupling mechanism 100. The mating mechanism 100 comprises one or more fingers extending proximally from the body of the hub 46. 102. Each of the one or more fingers 102 may be mounted on the ultrasonic instrument 22. When erected, the casing includes tabs extending radially outward relative to the longitudinal axis 94. The fingers 102 engage with a female fitting / mechanism on the distal portion 34 of the housing 30. configured to mate with and create a snap fit, interference fit, or other suitable connection. Other types of hub coupling mechanisms1 00 may be used to couple the irrigation sleeve assembly 44 to the housing 30. For example, the hub coupling mechanism 100 may be configured as a threaded connection. and exemplary configurations of irrigation sleeves are described in commonly owned U.S. patent application Ser. No. 16 / 580, 639 and International Patent Application No. PCT / US2019 / 052609, both of which are incorporated herein by reference in their entirety.

[0020] The hub 46 is configured to accommodate ultrasonically coupled irrigation sleeve assembly 44 when coupled to housing 30. a hub configured to at least partially accommodate a portion of the shaft 42 of the wave tip 40; The irrigation sleeve assembly 44 and the ultrasound tip 40 may define a lumen 98 (see FIG. 5). The combination of these may be referred to as a tool assembly 106.

[0021] As best seen in FIGS. 4-9, an irrigation sleeve 48 extends distally from the hub 46. The inner sheath 50 may include an inner sheath 52 having an opposed proximal end 54 and an opposed distal end 54. The inner sheath 50 at least partially surrounds the shaft 42 of the ultrasonic tip 40. The irrigation sleeve 48 also defines a lumen 56 that contains an outer sheath extending distally from the hub 46. The outer sheath 58 has a proximal end 60 and an opposite distal end 62. The outer diameter size of the side sheath 58 is not intended to be limiting, but may be minimally invasive. For invasive or keyhole type surgery, the irrigation sleeve 48 has an outer diameter of 10 mm. It is contemplated that the outer sheath 58 may be sized to be less than 1 / 4 inch (mm). For procedures, the outer sheath 58 is constructed to have an outer diameter of 7 millimeters (mm) or less. This allows the sleeve to be used in minimally invasive keyhole surgery.

[0022] The outer sheath 58 surrounds a portion of the inner sheath 50, and the outer sheath 58 and the inner sheath 50 form a The irrigation channel 64 defines an irrigation channel 64 for delivering irrigation fluid to a surgical site (not shown). The inner sheath 50 and the outer sheath 58 define an annular gap 108 therebetween. Together, they define an irrigation channel 64, as best seen in Figures 6-9. The straight gap 108 allows the irrigation sleeve 48 to have a relatively small diameter. The small diameter allows the user to access difficult-to-reach anatomical areas and allows for smaller access portals. Access portals allow for potentially faster recovery times. The side sheath 58 moves independently of the inner sheath 50, and the inner sheath 50 and the outer sheath 58 The inner sheath 50 and the outer sheath 55 may be configured to maintain an irrigation path 64 between them. Each of the outer sheath 58 and the inner sheath 59 may optionally comprise a flexible material. One of the side sheaths 50 may be omitted, and only a single sheath may be utilized.

[0023] The irrigation sleeve 48 is attached to the ultrasound tip 40 via an ultrasonic transducer. It may be more flexible than the sonic tip 40. The irrigation sleeve assembly 44 has a lumen 56 While maintaining the irrigation sleeve assembly 44 in place, slide it over the ultrasound tip 40. The lumen 56 of the inner sheath 50 may be configured to couple to the housing 30. 50 and the ultrasound tip 40. For example, if the user was performing a nose job using ultrasonic instrument 22, the user may attempt to access the surgical site through the patient's nasal passages. The outer sheath 58 may be subjected to radially inward forces from the patient's nasal passages. The gap 110 between the inner sheath 50 and the ultrasound tip 40 is maintained uniformly. In addition, the inner sheath 50 can be clamped while the ultrasound tip 40 is in place. The outer sheath 58 may continue to define a lumen 56 surrounding the lid 42, while the outer sheath 58 may extend inwardly. Therefore, in some instances, the inner sheath 50 is subjected to a radial force. 58, but in other exemplary configurations, the inner sheath 50 may have the same flexibility or may be configured to be less flexible than outer sheath 58. It is also contemplated that when a user attempts to reach a surgical site within a patient, irrigation may be The irrigation sleeve 48 may be temporarily pinched. The outer sheath 58 is secured to the inner sheath 50. The area of ​​the irrigation sleeve 48 that is clamped may be temporarily bent or deformed toward the Areas may be experiencing elevated temperatures due to a lack of irrigation fluid flowing through them. When the pinch is released, the inner sheath 50 and / or the outer sheath 58 The elasticity allows the material to bounce back to its original shape, allowing the fluid to flow again and reducing the temperature. The flexibility of the inner sheath 50 and the outer sheath 58 allows for pinching (a pinch). ch) locally compresses the inner sheath 50 and the outer sheath 58 so that they come into contact with each other. However, it allows fluid to travel to the surgical site near the distal end of the ultrasound tip 40. The lumen still exists. Localized cooling flows to the pinched area of ​​the irrigation sleeve 48. Instead, when the inner sheath 50 rubs against the vibrating ultrasonic tip 40, a pinch point (pinching point) occurs. h point) may become hot.

[0024] The irrigation sleeve assembly 44 is made of a polymer, such as a thermoplastic or The hub 46 and the irrigation system 40 may comprise any other suitable material, such as a tubular casing, ... The irrigation sleeve 48 may comprise one or more different types of polymers or other materials. In some configurations, the hub 46 may be made of a thermoplastic, synthetic polymer, polyoxymethylene (DELTA), or Polyacetal, POM, acetal, polyacetal, polyformaldehyde, polyether Polyetherketone (PEEK), metal, aluminum, steel, titanium, other suitable materials, and In some configurations, the inner shell of the irrigation sleeve 48 may be formed from a The outer sheath 50 and outer sheath 58 are made of perfluoroalkoxyalkane (PFA), polytetrafluoroethylene (PTFE), or Polytetrafluoroethylene (PTFE), other suitable synthetic fluoropolymers, polyolefins The liner may be formed from heat shrink materials such as, other suitable materials, and combinations thereof.

[0025] As shown with reference to FIG. 5, the distal end 54 of the inner sheath 50 is connected to the distal end 54 of the outer sheath 58. 62 to a distance (d). The shaft 42 of the ultrasound tip 40 proximal to the distal end 54 is placed in a relatively dry, irrigation fluid-free environment. at their distal ends 54, 62 longer than the outer sheath 58 to keep them free of The distance (d) is the distance that the irrigation fluid from the irrigation channel 64 passes through the inner sheath 50 and the ultrasound tip. 40. The inner sheath 50 and the ultrasonic tip 40 can be prevented from entering the gap 110. Irrigation fluid flowing and pooling in the gap 110 between the pump 40 can overheat the irrigation fluid and Otherwise, damage to the ultrasonic surgical assembly 20 may occur.

[0026] There are also concerns about increased temperature. The surgeon may not be aware of the temperature of the irrigation sleeve. This is a typical challenge in intranasal procedures, as there is a possibility of The inner sheath 50 is configured such that the distal end 54 of the inner sheath is flush with the distal end 62 of the outer sheath 58. It is also contemplated that the inner sheath 50 may be configured to be disposed in an inner The distal end 54 of the sheath may be configured to be disposed proximal to the distal end 62 of the outer sheath 58. The distal end 54 of the inner sheath 50 relative to the distal end 62 of the outer sheath 58 is The specific placement of the position of the ultrasound tip and / or surgical site relative to the distal portion 82 It may be configured based on the preferred flow pattern and / or spray direction of the fluid.

[0027] In some examples, the irrigation sleeve 48 may be configured to partially cover the ultrasound tip 40. To allow for effective encircling, a slit corresponding to the bend 80 in the ultrasound tip 40 is provided. The irrigation sleeve 48 may be flexible and may have a distal portion 87 and a distal portion 88. irrigation sleeve 48 may have a proximal portion 89 that faces the tip 40 when the irrigation sleeve 48 is placed over the ultrasound tip 40. The distal portion 87 of the irrigation sleeve 48 is bent relative to the proximal portion 89 of the irrigation sleeve 48. The sleeve bend 85 may also be configured to form a pre- In some instances, the irrigation sleeve 48 may be shaped to accommodate the irrigation sleeve 48. may be formed with additional bends, no bends, and / or other shapes. do.

[0028] As best seen in FIGS. 4 and 5, an annular sealing member 66 extends from the hub 46. The annular sealing member 66 is configured to prevent the escape of fluid from the hub 46, the inner seal circumferentially disposed around the outer sheath 50, the outer sheath 58, a combination thereof, or other suitable arrangement. For example, the annular sealing member 66 may be configured to seal the outer sheath 58. The outer sheath 58 is adapted to couple to the hub 46 and / or is formed between the outer sheath 58 and the hub 46. The annular sealing member 66 may be configured to create a fluid-tight seal between the hub and the joint. 46, may be welded to the hub 46, or may be threadedly connected to the hub 46. and / or may be coupled to the hub 46 using other acceptable fastening techniques. The hub 46 may include grooves, recesses, or barbs to assist in coupling the outer sheath 58 to the hub 46. It is also contemplated that the hub 46 may include a screw thread, a screw thread, or other similar features. When coupled to the hub 46, it creates a snap or press fit with the inner surface of the outer sheath 58. In one configuration, the annular sealing member 6 may include an annular groove on its outer surface configured to 6 is disposed around the hub 46 and outer sheath 58. In another configuration, an annular seal The lug member radially surrounds at least a portion of each of the outer surfaces of the hub 46 and the outer sheath 58. The annular sealing member 66 may be made of a polymer, elastomer, or the like. The annular sealing member 66 may comprise a sealing sleeve 67. The annular sealing member is configured such that at least a portion of the annular sealing member 66 is in contact with the outer sheath 58 and the and a joint formed between the outer sheath 58 and the hub 46 so that the outer sheath 58 is disposed over the hub 46. The annular sealing member 66 may comprise a heat shrink material that may be placed over the heat source. Once added to the material, the annular sealing member fits around the outer sheath 58 and hub 46. 46, thereby joining the outer sheath 58 to the hub 46 and forming a fluid-tight seal at the joint. The heat shrink material may be a fluoropolymer, a cross-linked fluoropolymer, a poly Crosslinked Polyether Block Amide with Olefin (PEBA), Medical Grade Polyolefin Fin, cross-linked acrylate olefin, polyvinylidene fluoride, polyvinylidene fluoride ( PVDF), high density polyethylene (HDPE), low density polyethylene (LDPE), poly Polyvinyl chloride (PVC), Viton(R), Neoprene(R), Kynar(R) , polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), Fluorinated ethylene propylene (FEP), combinations thereof, and / or other suitable A sealing material may be provided.

[0029] As shown in Figures 4, 5 and 10, the irrigation sleeve assembly 44 is To help create a seal between the tip 40 and the hub 46, a For example, as shown in FIGS. 4 and 5, Additionally, inner seal 104 comprises an O-ring disposed within a recess in hub 46. The screw 104 is disposed circumferentially around the shaft 42 of the ultrasound tip 40 within the hub 46. The inner seal 104 may be inserted between the inner sheath 50 and the ultrasound tip 40. An irrigation fluid and / or biological material may be applied to the outer surface of the ultrasonic trip and the inner sheath 50. The ultrasonic device 22 may be configured to prevent fluid from entering the housing 30 between the inner surface of the ultrasonic device 22 and the housing 30. The side seal 104 may be made of one or more polymers, elastomers, fluoroelastomers (e.g., FKM), Ethylene Propylene, Ethylene Propylene Diene Monomer (EPDM), Medical Grade grade silicone, nitrile, combinations thereof, or any other suitable sealing material It may comprise:

[0030] 5 and 10, the hub 46 includes a first hub portion 114 and a hub interface 116. and a second hub portion 116 connected to the first hub portion 114 to define a hub portion 118. The first hub portion 114 may be secured by welding, an interference fit, a snap fit, or any other suitable means. The first hub portion 114 may be connected to the second hub portion 116 by any suitable connection method. , fluid is delivered from irrigation line 70 to an irrigation passage defined between inner sheath 50 and outer sheath 58. The irrigation sleeve 48 may include an irrigation conduit 120 configured to feed the irrigation passage 64. 4 is formed by the arrangement of inner sheath 50 and outer sheath 58 relative to hub 46; As a result, the irrigation sleeve 48 is a specific fitting for coupling with the irrigation conduit 120. As shown in FIG. 6, the distal opening of the irrigation conduit 120 is The irrigation conduit 120 is disposed within the gap between the side sheath 50 and the outer sheath 58. irrigation fluid without the need for a specific mounting mechanism or coupler to connect to the 64 irrigation lines 7 0 may be in fluid communication with the irrigation conduit 120 by any suitable fluid connection. The irrigation lines are irrigation conduits such that irrigation fluid is delivered through the hub 46 to the irrigation channels 64. 10. The stent 120 may be configured to be disposed at the proximal end of the stent 120 (see FIG. 10).

[0031] Irrigation fluid can be introduced into irrigation passages 64 between the inner sheath 50 and the outer sheath 58. The fluid flowing from the irrigation conduit 120 to the irrigation channel 64 is affected by the flow resistance and the flow of the fluid through the first hub portion 11. 4 and the second hub portion 116. The ring sleeve 67 is inserted at the hub joint 118 to seal the hub joint 118. The first hub portion 114 and the second hub portion 116 may be at least partially surrounded by a tubular member. The sealing sleeve 67 can seal the first hub portion 114 to the second hub portion 116. The casing may provide structural strength for fastening to the

[0032] In some instances, the sealing sleeve 67 provides additional rigidity to the irrigation sleeve 48. The sealing sleeve 67 is located where the user grips the irrigation sleeve assembly 44. The sealing sleeve 67 is utilized to secure the irrigation sleeve assembly. This prevents twisting of the irrigation sleeve 48 when removing the sleeve 44 from the package. Additionally, the user can grasp the sealing sleeve 67 and insert it into the irrigation sleeve assembly. The assembly 44 can be removed from the ultrasonic instrument 22. For example, the sealing sleeve 67 can provide a barrier between the user and the irrigation sleeve 48.

[0033] As shown in FIGS. 5 and 10, the outer sheath 58 is annularly oriented about the second hub portion 116. The outer sheath may include an outer sheath flange 122 that engages the collar to define an outer sheath interface 124. The outer sheath flange 122 may be press fit into the annular collar of the second hub portion 116. and may be welded to the annular collar and / or otherwise attached to the second hub portion 1. 16. The outer sheath flange 122 may be cylindrical in shape. , and / or other shapes for engaging with the second hub portion 116. The ring member 66 is connected to the second hub portion 116 and the outer sheath at an outer sheath juncture 124. It at least partially surrounds the sheath 58 and seals the outer sheath joint 124. Similar to the portion 118, the outer sheath interface 124 is a junction between the second hub portion 116 and the outer sheath frame. The sealing sleeve 122 may be subjected to fluid resistance and related forces acting between the sealing sleeve 122 and the 67 provides strength to sealably secure the outer sheath 58 to the second hub portion 116. provide.

[0034] The inner sheath 50 engages with the annular collar of the first hub portion 114 to form the inner sheath joint 116. The inner sheath flange 126 may define an inner sheath flange 126 that defines a sheath 28. The first hub portion 114 may be press-fitted into an annular collar and may be welded to the annular collar. and / or may be otherwise coupled to the first hub portion 114. For example, the inner sheath flange 126 is secured to the first hub by the second annular sealing member 53. The second annular sealing member 53 may be attached to the inner sheath of the inner sheath. A flange 126 at least partially surrounds the flange 126 and is press-fit into an annular collar of the first hub portion 114. The second annular sealing portion may be configured to define an inner sheath junction 128. The material 53 is bonded to the first hub 114 portion by welding, epoxy, or a similar adhesive. It is also contemplated that a second annular sealing member 53 may be provided to secure the inner sheath 50 to the hub. It is also contemplated that the hub 46 may be configured to be threadably coupled to the inner To assist in coupling the sheath 50 to the hub 46, grooves, recesses, barbs, threads, or Other similar features may be included. For example, the hub 46 may be configured to , an annular groove on its outer surface configured to create a snap or press fit with the inner surface of the inner sheath 50 The second annular sealing member 53 is disposed on the inner sheath flange 126. and a heat shrink material configured to be heat treated to bond the inner sheath 50 to the hub 46. It is further contemplated that the inner sheath flange 126 may comprise a cylindrical material. and / or may have other shapes for engaging with first hub portion 114. The inner sheath joint 128 is at least partially surrounded by an annular sealing member 66. The inner sheath flange 126 can be attached to the first hub portion 114 and the second hub portion 116. The second annular sealing member 5 may be radially captured between the first annular sealing member 5 and the second annular sealing member 5. 3, at least a portion of the second annular sealing member 53 is inserted between the inner sheath 50 and the hub 4. 6, an inner sheath joint formed between the inner sheath 50 and the hub 46. The second annular sealing member 53 may comprise a heat shrink material that may be placed over the joint 128. When a heat source is applied to the heat shrink material, the second annular sealing member 53 seals the inner sheath 50. and shrinks around the hub 46, joining the inner sheath 50 to the hub 46, forming an inner sheath joint 128. As noted above, the hub 46 may be configured to form a fluid-tight seal at 128. A groove or similar may be provided to facilitate mating and creation of a seal between the hub 46 and the inner sheath. The heat shrink material may be a fluoropolymer, a cross-linked fluoropolymer, a polyolefin, or a combination thereof. Cross-linked Polyether Block Amide (PEBA), Medical Grade Polyolefin with Fins Polyvinylidene fluoride, cross-linked acrylate olefin, polyvinylidene fluoride (PV DF), high density polyethylene (HDPE), low density polyethylene (LDPE), polychlorinated Vinyl (PVC), Viton(R), Neoprene(R), Kynar(R), Polyethylene Polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), Fluorine FEP, combinations thereof, and / or other suitable sheets. The ring may comprise a material.

[0035] In some examples, the irrigation channels 64 may utilize capillary action to direct fluid for irrigation. 120 to the distal ends 54, 62 of the inner sheath 50 and outer sheath 58. Also known as capillary action, capillary movement, capillary effect, or wicking Capillary action, which occurs when fluid moves through narrow spaces without the aid of, or even against, external forces such as gravity. The capillary action of the fluid through the irrigation channels 64 may be due to the ability of the fluid to flow through the narrow spaces. The ultrasonic surgical assembly 20 is configured to uniformly distribute the heat generated by the tip 40 without causing damage to the ultrasonic surgical assembly 20. This can be advantageous as it can prevent heat buildup that could otherwise result.

[0036] The ultrasound tip 40 is disposed on the shaft 42 as shown in FIGS. 5 and 11. The nozzle may include an opening 112 configured to be in fluid communication with the suction passage 28. The opening 112 may include: The vibration transducer mechanism 96 may be located proximal to the distal end 54 of the inner sheath 50. The axis of the opening 112 can intersect the suction passage 28. In some configurations, The axis of the opening 112 may be perpendicular to the suction passage 28. The diameter of the opening 112 may be perpendicular to the suction passage 28. The opening 112 may be smaller than the diameter of the flow passage 28 due to the suction of fluid into the suction passage 28. Body fluids can be prevented from flowing between the ultrasound tip 40 and the inner sheath 50. In some examples, there may be additional openings 112, and in some examples, openings 112 may not be available.

[0037] 12 and 13 show a perspective view and a cross-sectional view of the hub 46, respectively, and the first hub The portion 114 may include a plurality of hub components, such as a first hub component 130 and a second hub component 132. The first hub part 130 is connected to the second hub part 132 to form a second hub connector. At least one annular sealing member 66 is utilized to define a joint 134. The second hub portion 114 can be fluid-tightly sealed to the second hub portion 116. Another annular sealing member 66 is utilized to seal the first hub at the second hub interface 134. The hub component 130 may be fluid-sealed to a second hub component 132 .

[0038] In some examples, the annular sealing member 66 is attached to the first hub at the hub interface 118. hub joint 118 in fluid-tight engagement with portion 114 and second hub portion 116. Further, another ring 136 may be provided as shown in FIG. 13, first hub part 130 is engaged with second hub part 132. In some examples, the ring 136 may be configured to seal the flow from the hub 46. The first hub portion 114 is sealably secured to the second hub portion 116 to prevent bodily spillage. As described above, the elastomeric ring is configured to allow the irrigation fluid to pass through the housing 30. Fluid moving into the irrigation sleeve 48 experiences a pressure drop and increased resistance. , engage and seal the first hub portion 114 to the second hub portion 116 to reduce pressure drop and In some cases, other rings may be used to overcome the increased resistance. 136 secures the first hub component 130 to further prevent fluid from leaking from the hub 46. an elastomeric ring configured to sealably secure to the second hub component 132; The ring 136 may be made of one or more polymers, elastomers, fluoroelastomers (e.g., FKM), Ethylene Propylene, Ethylene Propylene Diene Monomer (EPDM), Medical Grade grade silicone, nitrile, combinations thereof, or any other suitable sealing material It may comprise:

[0039] In some configurations, the first hub component 130, the second hub component 132, the first hub portion 114, and second hub portion 116 may be secured by any combination of annular sealing members 66. For example, the first hub portion 114 and The second hub portion 116 includes at least one ring 136 and at least one seal. The seal may be sealably secured by a retaining sleeve 67, a retaining sleeve 68, or any combination thereof. Other forms of sealing members are contemplated for use in the embodiments described herein. Additionally, the annular sealing member 66 is secured to the hub 46, and / or the inner sheath 50, and / or or outer sheath 58, so as to partially or completely surround the outer sheath 58. Other shapes of sealing member 66 are also contemplated.

[0040] As shown with reference to FIG. 14, for removing / cutting biological material 12A from a patient 10, The irrigation sleeve assembly 48 and ultrasound tip 40 are utilized by medical professionals. An exemplary configuration of the ultrasonic surgical assembly 20 is shown, including: minimally invasive surgery or keyhole When performing a medical procedure, such as surgery, a medical professional may use an ultrasound tip 40 and / or an ultrasound At least a portion of the irrigation sleeve assembly 48 of the ultrasonic surgical assembly 20 is removed from the patient. An access portal is provided to access the biological material to be cut and / or removed. The access portal 216 can be inserted into the patient 10. 6 is a biological material to be cut and / or removed by the ultrasonic surgical assembly 20. The access device 12A may comprise any type of opening in the patient 10 that provides access to the access device 12A. The portal 216 is formed using a dilator / retractor 200 to expand an existing opening. For example, as shown in FIG. 14, a medical professional may utilize a dilator 200 to As described above, the access portal 216 can be created and / or defined. The outer diameter of the outer sheath 58 of the irrigation sleeve assembly 48 is generally 7 millimeters (mm). The dilator 200 may be configured such that the ultrasonic surgical assembly 20: To limit the impact on the patient 10 and reduce healing time, accessing the biological tissue 12A to be cut and / or removed while minimizing the opening created Access with an internal diameter of approximately 20 to 28 millimeters (mm) to allow It may be configured to define a portal 216 .

[0041] Alternatively, the access portals 16A, 16B may be used with a high-speed burr or other similar medical cutting device. It is also contemplated that the device may be used to amputate the patient. As shown with reference to FIG. Burr the access portals 16A, 16B defined by cutting openings in the skull. For example, medical professionals may utilize a high-speed burr to create a burr at the back of the skull. Portal 16A can be cut and accessed to provide access to the tumor 12B on the brain. Alternatively, a medical professional may utilize a high-speed burr to insert a portal 1 through the nasal passages of the patient 10. 6B is cut to provide access to the tumor 12C, which is removed from the patient's nasal cavity. It is contemplated that the portal 16B may comprise a pre-existing orifice of the patient. For example, the nasal cavity For intracranial surgery, the access portals include the patient's nose and / or nasal passages and the base of the patient's skull. As described above, the outer sheath 58 of the irrigation sleeve assembly 48 The outer diameter of the catheter may generally be configured to be 7 millimeters (mm) or less. To limit recoil and speed healing time, a high-speed burr is utilized, with an inner diameter of approximately 12 to 20 mm. 2. Cut / define access portals 16A, 16B having diameters (mm) to provide access to the patient. 1. The ultrasonic surgical assembly for cutting a surgical instrument while minimizing the opening that is defined / cut in the surgical instrument. and / or access to the biological tissue to be removed.

[0042] Ultrasonic cutting tip with dual lumen irrigation sleeve for performing minimally invasive surgery A method for using a surgical assembly with a dual lumen irrigation sleeve within a patient access portal The dual lumen irrigation sleeve may be disposed at least partially within the outer sheath. The inner sheath and the outer sheath may each have a hub and a corresponding The annular sheath is configured to create a fluid-tight seal between the inner and outer sheaths. The irrigation sleeve may be connected to the hub of the irrigation sleeve by a ring member. While the sleeve is at least partially positioned within the patient access portal, The method may further comprise cutting the access point of the patient using the dilator. The dilator may further comprise defining a 20 to 28 millimeter (mm) diameter. Larger or smaller dilators may be used as needed. This method also involves creating a patient access portal in the patient's skull using a high-speed burr. The access portal may have an inner diameter of 10 to 20 millimeters (mm). The access portal may be generally square, triangular, rectangular, It is also contemplated that the marker may have a similar polygonal shape. can be used to cut smaller or larger access portals. In another exemplary configuration, a cutting tip including a dual lumen irrigation sleeve is attached to the nasal and / or The device can be inserted through an access portal defined by the nasal cavity to perform an intranasal procedure. The irrigation sleeve is designed so that the outer diameter of the outer sheath is 7 millimeters (mm) or less. It can be configured as follows.

[0043] Dual-lumen irrigation sleeve for use with ultrasonic surgical instruments to perform minimally invasive surgery A method of manufacturing the sleeve comprises coupling an inner sheath to a hub of a dual lumen irrigation sleeve. The method further comprises disposing a first annular sealing member at least partially over the hub and the inner sheath. a first annular sealing member disposed at least partially around the first annular sealing member; 1 annular sealing member to define a fluid-tight seal between the hub and the inner sheath. The method may also include coupling the outer sheath to the hub of the dual lumen irrigation sleeve. the outer sheath defines a lumen and the inner sheath is at least partially within the lumen. The method further includes disposing a second annular sealing member over the hub and the outer sheath. disposing a second annular sealing member at least partially disposed on the heat A source is applied to the second annular sealing member to define a fluid-tight seal between the hub and the outer sheath. The inner and outer sheaths may be configured to deliver irrigation fluid to the surgical site. The hub may define an irrigation channel defined by the inner sheath and the outer sheath. The outer sheath may have an irrigation conduit at the hub thereof in fluid communication with the irrigation sleeve. The first and second annular shells may be configured to be less than a millimeter (mm). Each of the ring members may comprise a heat shrink material.

[0044] Terms: I. An ultrasonic surgical assembly comprising: 1. An ultrasonic instrument having a proximal end and a distal end, a housing having a proximal portion and a distal portion; a transducer at least partially disposed within the housing; a horn coupled to the transducer; an ultrasonic tip having a shaft coupled to the horn; an ultrasonic instrument comprising: 1. An irrigation sleeve assembly comprising: a hub releasably coupled to the distal portion of the housing; an irrigation sleeve coupled to the hub; an irrigation sleeve assembly comprising: The irrigation sleeve comprises: an inner sheath extending distally from the hub and having a proximal end and an opposite distal end; an inner sheath defining a lumen at least partially surrounding the shaft of the ultrasound tip; Su and an outer sheath extending distally from the hub and having a proximal end and an opposite distal end; and an outer sheath configured to The outer sheath surrounds a portion of the inner sheath, and the outer sheath and the inner sheath Irrigation channels were established between the two areas. The irrigation channel is configured to deliver irrigation fluid to a surgical site.

[0045] II. The ultrasonic surgical assembly of claim I, further comprising: The sealing member is configured to:

[0046] III. The ultrasonic surgical assembly of clause II, wherein said hub defines a hub joint. To determine the distance, a first hub portion and a second hub portion connected to the first hub portion are provided. the annular sealing member is attached to the hub joint to seal the hub joint. a seal at least partially surrounding the first hub portion and the second hub portion; Equipped with a ring sleeve.

[0047] IV. The ultrasonic surgical assembly of clause III, wherein said outer sheath is an outer sheath flange that engages with the hub portion of the annular sheath to define an outer sheath joint; A sealing member is attached to the outer sheath joint to seal the outer sheath joint. a second hub portion at least partially surrounding the second hub portion and the outer sheath;

[0048] V. The ultrasonic surgical assembly of clause III or IV, wherein the inner sheath comprises: an inner sheath flange that engages the first hub portion to define an inner sheath interface; The inner sheath joint is at least partially surrounded by the annular sealing member. do.

[0049] VI. The ultrasonic surgical assembly of clause II, wherein said hub defines a hub joint. a first hub portion and a second hub portion connected to the first hub portion for The annular sealing member is attached to the hub joint to seal the hub joint. an engine configured to engage the first hub portion and the second hub portion; Equipped with a stamper ring.

[0050] VII. The ultrasonic surgical assembly of any of clauses I through VI, wherein said ultrasonic an inner annular sealing portion disposed on the hub for sealing between the tip and the hub; The device further includes a material.

[0051] VIII. The ultrasonic surgical assembly of any of clauses I to VII, wherein said system The shaft includes an opening configured to be in fluid communication with the suction passage, the opening having a front Located proximal to the distal end of the inner sheath.

[0052] IX. The ultrasonic surgical assembly of any of clauses I to VIII, wherein said ultrasonic The ultrasonic tip comprises a distal portion and an opposing proximal portion, the distal portion of the ultrasonic tip is bent relative to the proximal portion of the ultrasound tip.

[0053] X. The ultrasonic surgical assembly of claim IX, wherein said irrigation sleeve is The distal portion of the tip has a corresponding bend.

[0054] XI. The ultrasonic surgical assembly of any of clauses I to X, wherein said irrigation sleeve The tip is attached to the ultrasound tip to place the irrigation sleeve over the ultrasound tip. It is more flexible than

[0055] XII. The ultrasonic surgical assembly of any of clauses I through IX and XI, The outer sheath is configured to maintain the irrigation path between the inner sheath and the outer sheath. and configured to move radially independently from the inner sheath.

[0056] XIII. The ultrasonic surgical assembly of any of clauses I to XII, wherein said irrigation The inner sheath and the outer sheath of the irrigation sleeve assembly define the irrigation passageway. To do this, an annular gap is formed between them.

[0057] XIV. The ultrasonic surgical assembly of any of clauses I to XIII, wherein said The lumen of the side sheath defines a gap between the inner sheath and the ultrasound tip. It is said to be of a similar size.

[0058] XV. The ultrasonic surgical assembly of any of clauses I to XIV, wherein said ultrasonic The device defines a suction passage.

[0059] XVI. A tool assembly comprising: an ultrasonic tip; an irrigation sleeve assembly, the irrigation sleeve assembly comprising: Hub and an irrigation sleeve coupled to the hub, the irrigation sleeve comprising: an inner sheath extending distally from the hub and having a proximal end and an opposite distal end; an inner sheath defining a lumen at least partially surrounding the shaft of the ultrasound tip; Su and an outer sheath extending distally from the hub and having a proximal end and an opposite distal end; and an outer sheath for receiving the The outer sheath surrounds a portion of the inner sheath, and the outer sheath and the inner sheath Irrigation channels will be established between the base and the The irrigation channel is configured to deliver irrigation fluid to a surgical site.

[0060] XVII. The tool assembly of clause XVI, further comprising: a spring for preventing fluid from flowing out of said hub; The device further includes an annular sealing member configured to seal the inner wall of the device.

[0061] XVIII. The tool assembly of clause XVII, wherein said hub comprises a hub joint. To define the first hub portion, a second hub portion connected to the first hub portion; the annular sealing member is provided at the hub joint to seal the hub joint. a shell at least partially surrounding the first hub portion and the second hub portion; Equipped with a ring sleeve.

[0062] XIX. The tool assembly of clause XVIII, wherein said outer sheath is an outer sheath flange that engages with the hub portion of the annular sheath to define an outer sheath joint; A sealing member is attached to the outer sheath joint to seal the outer sheath joint. a second hub portion at least partially surrounding the second hub portion and the outer sheath;

[0063] XX. The tool assembly of clause XVIII or XIX, wherein the inner sheath an inner sheath flange that engages with the first hub portion to define an inner sheath joint; The inner sheath joint is at least partially surrounded by the annular sealing member. can be.

[0064] XXI. The tool assembly of clause XVII, wherein the hub defines a hub interface. a first hub portion and a second hub portion connected to the first hub portion for The annular sealing member is attached to the hub joint to seal the hub joint. an engine configured to engage the first hub portion and the second hub portion; Equipped with a stamper ring.

[0065] XXII. The tool assembly of any one of clauses XVI to XXI, wherein the hub an inner annular member disposed on the ultrasonic tip and configured to seal between the ultrasonic tip and the hub; A sealing member is further included.

[0066] XXIII. A tool assembly according to any one of clauses XVI to XXII, The shaft includes an opening configured to be in fluid communication with the aspiration passage, the opening comprising: Located proximal to the distal end of the inner sheath.

[0067] XXIV. A tool assembly according to any one of clauses XVI to XXIII, The ultrasound tip comprises a distal portion and an opposing proximal portion, the distal portion being in contact with the proximal portion. flexes relative to the min.

[0068] XXV. The tool assembly of clause XXIV, wherein said irrigation sleeve is The distal portion of the wave tip has a corresponding bend.

[0069] XXVI. A tool assembly according to any one of clauses XVI to XXIV, The irrigation sleeve is attached to the ultrasound tip. It is more flexible than the tip.

[0070] XXVII. Tool assemblies according to any of clauses XVI to XXIV and XXVI the outer sheath maintains the irrigation path between the inner sheath and the outer sheath, The sheath is configured to move radially independently from the inner sheath to support the sheath.

[0071] XXVIII. A tool assembly according to any one of clauses XVI to XXVII, The lumen of the inner sheath defines a gap between the inner sheath and the ultrasound tip. The size is determined as follows.

[0072] XXIX. A tool assembly according to any of Articles XVI to XXVIII, The inner sheath and the outer sheath of the irrigation sleeve assembly define the irrigation passage. An annular gap is formed between them to allow the

[0073] XXX. Tool assemblies according to any of Articles XVI to XXIX, The cap includes a shaft that defines a suction passage.

[0074] XXXI. AN ULTRASONIC SURGICAL ASSEMBLY, COMPRISING: 1. An ultrasonic instrument having a proximal end and a distal end and defining an aspiration path, comprising: a housing having a proximal portion and a distal portion; a transducer at least partially disposed within the housing; a horn coupled to the transducer; an ultrasonic tip having a shaft coupled to the horn; an ultrasonic instrument comprising: 1. An irrigation sleeve assembly comprising: a hub releasably coupled to the distal portion of the housing; An irrigation sleeve coupled to the hub and configured to define an irrigation path for delivering irrigation fluid to the surgical site, the irrigation sleeve comprising: an inner sheath extending distally from the hub and having a proximal end and an opposite distal end; the inner surface defining a lumen configured to at least partially surround the ultrasound tip; a side sheath; an annular sealing member surrounding the hub and at least a portion of the irrigation sleeve; and a front end configured to prevent fluid from flowing out of the hub and the irrigation sleeve. and the annular sealing member.

[0075] XXXII. A tool assembly comprising: an ultrasound tip having a shaft defining an aspiration channel; an irrigation sleeve assembly, the irrigation sleeve assembly comprising: Equipped with a hub, An irrigation sleeve coupled to the hub and configured to define an irrigation path for delivering irrigation fluid to the surgical site, the irrigation sleeve comprising: an inner sheath extending distally from the hub and having a proximal end and an opposite distal end; an inner sheath defining a lumen configured to at least partially surround the ultrasound tip; and, an annular sealing member surrounding the hub and at least a portion of the irrigation sleeve; a ring configured to prevent fluid from flowing out of the hub and the irrigation sleeve; and a sealing member.

[0076] Several configurations have been discussed in the preceding description. However, the The illustrated structures are not intended to be exhaustive or to limit the invention to any particular form. For example, the exemplary configuration describes the surgical tool as an ultrasonic surgical assembly. Although the features and concepts described with respect to ultrasonic surgical assemblies are not intended to be limiting, the present invention is not limited to the specific embodiments described herein. It is further contemplated that this may be applied to medical or surgical instruments. ultrasonic chisels, which may further include drill bits, rotary burrs, open window shavers, etc. The terminology 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 present invention may be practiced in accordance with the teachings specifically described. It may be implemented in ways other than those described.

Claims

1. 1. A method of manufacturing an irrigation sleeve assembly for use with an ultrasonic surgical instrument to perform minimally invasive surgery, comprising: coupling an irrigation sleeve to a hub of the irrigation sleeve assembly; applying a heat source to an annular sealing member disposed at a proximal end of the irrigating sleeve to define a fluid-tight seal between the hub and the irrigating sleeve; A method comprising:

2. the irrigation sleeve comprises a flange; coupling the irrigation sleeve to the hub of the irrigation sleeve assembly includes engaging a collar of the hub with the flange to form a joint; The method of claim 1 , wherein applying the heat source to the irrigation sealing member seals the joint.

3. The method of claim 2 , wherein the hub includes grooves, depressions, or barbs that assist in coupling the irrigation sleeve to the hub.

4. 4. The method of claim 1, wherein the irrigation sleeve is formed from a heat shrink material.

5. 5. The method of claim 4, wherein the hub is formed from a thermoplastic.

6. 6. The method of claim 1, further comprising disposing an inner annular sealing member within the hub to provide a seal between the hub and an ultrasonic tip of the ultrasonic surgical instrument when inserted into the hub.

7. 7. The method of claim 1, wherein the irrigation sleeve includes a bend that corresponds to a bend in the ultrasonic tip of the ultrasonic surgical instrument.

8. the hub comprising a first hub portion and a second hub portion, the first hub portion including a hub coupling mechanism configured to couple the hub to a housing of the ultrasonic surgical instrument; The method comprises: coupling the irrigation sleeve to the second hub portion to define a sleeve interface between the irrigation sleeve and the second hub portion; coupling the second hub portion to the first hub portion to define a hub interface; applying the heat source to the annular sealing member disposed at the proximal end of the irrigation sleeve to create a fluid-tight seal between the hub interface and the sleeve interface; 8. The method according to claim 1, comprising:

9. the hub comprising a first hub portion and a second hub portion, the first hub portion including a hub coupling mechanism configured to couple the hub to a housing of the ultrasonic surgical instrument; The method comprises: coupling the irrigation sleeve to the second hub portion to define a sleeve interface between the irrigation sleeve and the second hub portion; coupling the second hub portion to the first hub portion to define a hub interface; applying the heat source to the annular sealing member disposed at the proximal end of the irrigation sleeve to fluid-tightly seal the sleeve junction; placing an elastomer ring at the hub interface to seal the hub interface; 8. The method according to claim 1, comprising:

10. an irrigation conduit extending through a portion of the hub; The method comprises: positioning the annular sealing member such that a distal end of the irrigation conduit is located between the hub and the annular sealing member; applying the heat source to the annular sealing member such that the annular sealing member is secured about the distal end of the irrigation conduit; 10. The method according to claim 1, comprising:

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