Ultrasonic surgical assembly with air cooling broad knife and irrigation sleeve

Abstract

To provide an ultrasonic surgical assembly for use with a surgical handpiece to provide air cooling of an ultrasonic tip.SOLUTION: An ultrasonic tip 20 comprises a shaft and a cutting portion. The tip comprises a first side and a second side that are substantially planar and a cutting head. The tip is removably coupled to a horn. An assembly comprises an irrigation sleeve 18 defining a lumen. The sleeve at least partially surrounds the shaft, defines an inlet aperture, and comprises a conduit in fluid communication with the lumen. The conduit has an outlet aperture and is configured to be connected to a liquid source. The tip comprises a sealing member coupled to its outer surface, and has a first bore defining an air inlet disposed on the proximal side of the sealing member and a second bore extending from the proximal end of the shaft to the first bore to form a fluid bath therebetween.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] Related Applications This application claims priority and all benefits of U.S. Provisional Patent Application No. 63 / 127,8 02, filed on December 18, 2020, and U.S. Provisional Patent Application No. 63 / 197,773, filed on June 7, 2021, and the entire contents of these U.S. Provisional Patent Applications are incorporated herein by reference. into this application.

Summary of the Invention

[0002] An ultrasonic surgical assembly for air-cooling an ultrasonic chip is disclosed. The ultrasonic surgical assembly includes an ultrasonic chip and an irrigation sleeve. The ultrasonic chip includes a shaft and a cutting portion, and has a first side surface and a second side surface. The first side surface is substantially flat and extends from the proximal end to the distal end. The second side surface is substantially flat and is disposed on the opposite side of the first side surface and extends from the proximal end to the distal end. The cutting portion includes a cutting head disposed at the distal end. The ultrasonic chip is removably coupled to a horn. The shaft further includes a longitudinal axis. The irrigation sleeve has a distal region and a proximal region and defines a lumen extending along the longitudinal axis. The irrigation sleeve at least partially surrounds the shaft and defines an inlet opening. The irrigation sleeve further includes a first conduit in fluid communication with the lumen. The first conduit has an outlet opening and is configured to be connected to a liquid source. The ultrasonic chip further includes a seal member coupled to its outer surface and further defines a first hole and a second hole. The first hole defines an air inlet disposed on the proximal side of the seal member, and the second hole extends from the proximal end of the shaft to the first hole and forms a fluid path between the first hole and the second hole. ​​​​​​​​ constitutes.

[0003] A second ultrasonic surgical assembly is disclosed. The assembly includes an ultrasonic instrument, an ultrasonic chip, and an irrigation sleeve. The ultrasonic instrument includes a housing, a transducer, and a horn. The housing includes a proximal portion and a distal portion. The transducer is at least partially disposed within the housing. The horn is coupled to the transducer. The ultrasonic chip includes a shaft and is removably coupled to the horn. The irrigation sleeve defines a lumen and includes a body, a sheath, and an irrigation conduit. The body is releasably coupled to the distal portion of the housing and has a distal region and a proximal region. The body defines a helical groove that at least partially surrounds the shaft when the ultrasonic chip is within the lumen of the irrigation sleeve. The sheath is coupled to a portion of the body so as to surround at least one full rotation of the helical groove and is disposed over a portion of the body. The sheath has a distal end opposite the proximal end. The irrigation conduit is disposed within the helical groove for carrying irrigation fluid and defines an inlet opening and an outlet opening. The inlet opening is disposed in the proximal region of the body, and the outlet opening is disposed in the distal region of the body. The irrigation fluid enters the irrigation conduit at the inlet opening and exits the irrigation conduit at the outlet opening. An ultrasonic chip including a shaft and a cutting portion is disclosed. The shaft defines a longitudinal axis. The cutting portion defines a first side that is substantially planar and a second side that is substantially planar and includes a cutting head.

[0004] The cutting portion includes a base portion having a lateral dimension between the first side and the second side that extends perpendicular to the longitudinal axis of the cutting head. The cutting portion includes a chamfered portion. It further includes a tapered portion extending from the base portion to the cutting edge. The cutting edge has a certain length and has a U-shaped contour with a first leg, a second leg, and an arcuate distal portion. The first leg and the second leg are parallel to each other. Further, the maximum cross-sectional area of the ultrasonic chip defines the cross-sectional area of the first slice. The cross-sectional area of the second slice is defined at a position 20 mm proximal to the distal end of the ultrasonic chip . The second slice and the first slice are each perpendicular to the longitudinal axis of the shaft. The cross-sectional area of the second slice is 16.7 - 20% of the cross-sectional area of the first slice.

[0005] A second ultrasonic surgical assembly for air-cooling an ultrasonic chip is disclosed. The ultrasonic surgical assembly includes an ultrasonic instrument, an ultrasonic chip, an irrigation sleeve, and a seal member. The ultrasonic instrument has a proximal region and a distal region and includes a housing, a transducer, and a horn. The housing has a proximal portion and a distal portion. The transducer is at least partially disposed within the housing. The horn is coupled to the transducer, and the transducer is configured to be coupled to a suction source by a first coupler. The ultrasonic chip includes a shaft and a cutting portion and is removably coupled to the horn by a chip coupler. The shaft has a longitudinal axis. The irrigation sleeve has a distal region and a proximal region and defines a lumen. The irrigation sleeve at least partially surrounds the shaft and defines an inlet opening configured to receive irrigation fluid from an irrigation source. The irrigation sleeve further includes a first conduit in fluid communication with the lumen. The first conduit is configured to carry irrigation fluid from the inlet opening to an outlet opening. The seal member is positioned between the outer surface of the ultrasonic chip and the inner surface of the lumen. ​ The ultrasonic chip defines a first hole and a second hole. The first hole defines an air inlet disposed proximal to the seal member when the perfusion sleeve and the ultrasonic chip are coupled to the ultrasonic instrument. The second hole extends from the proximal end of the ultrasonic chip to the first hole. The second hole communicates with a suction source via a chip coupler. When the perfusion sleeve and the ultrasonic chip are coupled to the ultrasonic instrument, the perfusion sleeve defines a third hole proximal to the first hole. The ultrasonic surgical assembly defines a path for drawing air from the ambient environment through the third hole, then through the first hole, and then back through the second hole before the air exits the ultrasonic surgical assembly at the first coupler.

[0006] A method of cutting bone using an ultrasonic chip is disclosed. The method includes providing an ultrasonic chip comprising a shaft and a cutting portion removably coupled to a horn by a chip coupler. The horn is coupled to a transducer, and the transducer is coupled to a suction source by a first coupler. The shaft comprises a longitudinal axis. The ultrasonic chip defines a first hole defining an air inlet and a second hole extending from the proximal end of the ultrasonic chip to the first hole. The first hole is transverse to the second hole, and the second hole communicates with a suction source via a chip coupler. The method further includes providing a perfusion sleeve having a distal region and a proximal region and defining a lumen. The perfusion sleeve at least partially surrounds the shaft and is configured to be coupled to a perfusion source by an inlet opening configured to receive perfusion fluid from the perfusion source. The perfusion sleeve defines a first conduit in fluid communication with the lumen. The first conduit conducts perfusion fluid to the inlet opening. ​ configured to carry from the mouth to the outlet opening. The method further includes drawing air through the second hole and the first hole through a suction source to cool the ultrasonic chip.

[0007] A third ultrasonic surgical assembly is disclosed. The assembly includes an ultrasonic instrument, an ultrasonic chip holder, and an irrigation sleeve. The ultrasonic instrument includes a housing, a transducer, and a horn. The housing has a proximal portion and a distal portion. The transducer is at least partially disposed within the housing. The horn is coupled to the transducer. The ultrasonic chip holder includes a shaft and a cutting portion and is removably coupled to the horn. The irrigation sleeve defines a lumen and has a body releasably coupled to the distal portion of the housing, having a distal region and a proximal region. The ultrasonic chip further includes an annular seal member defining a groove, the annular seal member being disposed around the groove, disposed in the proximal region of the body, and positioned between the outer surface of the ultrasonic chip and the inner surface of the lumen when the sleeve and the ultrasonic chip are connected to the ultrasonic instrument. The annular seal member is configured to prevent fluid movement on the proximal side of the annular seal member.

[0008] A fourth ultrasonic surgical assembly is disclosed. The assembly includes an ultrasonic instrument and an irrigation sleeve. The ultrasonic instrument includes a housing, a transducer, and a horn. The housing has a proximal portion and a distal portion. The transducer is at least partially disposed within the housing. The horn is coupled to the transducer. The irrigation sleeve defines a lumen and is removably coupled to a first ultrasonic chip and a second ultrasonic chip. ​​It is composed of sea urchins. Each of the first ultrasonic chip and the second ultrasonic chip is configured to be removably coupled to the horn by a chip coupler. Each of the first ultrasonic chip and the second ultrasonic chip includes a shaft, a cutting portion, and an annular seal member. The cutting portion of the first ultrasonic chip has a cutting shape different from that of the cutting portion of the second ultrasonic chip. The first ultrasonic chip defines a first groove located at a first distance from the chip coupler of the first ultrasonic chip. The second ultrasonic chip defines a second groove located at a second distance from the chip coupler of the second ultrasonic chip. The first distance from the chip coupler of the first ultrasonic chip is not equal to the second distance from the chip coupler of the second ultrasonic chip. Each of the first ultrasonic chip and the second ultrasonic chip includes an annular seal member disposed around each of the first and second grooves. The perfusion sleeve includes a main body and a perfusion conduit. The main body is releasably coupled to the distal portion of the housing. The perfusion conduit is coupled to the main body and is configured to carry a perfusion fluid. The perfusion conduit further defines an inlet opening disposed in the proximal region of the main body and an outlet opening disposed in the distal region of the main body, and the perfusion fluid enters the perfusion conduit through the inlet opening and exits the perfusion conduit through the outlet opening. It is configured to be removably coupled to the horn by a chip coupler. Each of the first ultrasonic chip and the second ultrasonic chip includes a shaft, a cutting portion, and an annular seal member. It is configured to be removably coupled to the horn by a chip coupler. Each of the first ultrasonic chip and the second ultrasonic chip includes a shaft, a cutting portion, and an annular seal member. The cutting portion of the first ultrasonic chip has a cutting shape different from that of the cutting portion of the second ultrasonic chip. The first ultrasonic chip defines a first groove located at a first distance from the chip coupler of the first ultrasonic chip. The second ultrasonic chip defines a second groove located at a second distance from the chip coupler of the second ultrasonic chip. The first distance from the chip coupler of the first ultrasonic chip is not equal to the second distance from the chip coupler of the second ultrasonic chip. The first distance from the chip coupler of the first ultrasonic chip is not equal to the second distance from the chip coupler of the second ultrasonic chip. Each of the first ultrasonic chip and the second ultrasonic chip includes an annular seal member disposed around each of the first and second grooves. The perfusion sleeve includes a main body and a perfusion conduit. The main body is releasably coupled to the distal portion of the housing. The perfusion sleeve includes a main body and a perfusion conduit. The main body is releasably coupled to the distal portion of the housing. The perfusion conduit is coupled to the main body and is configured to carry a perfusion fluid. The perfusion conduit further defines an inlet opening disposed in the proximal region of the main body and an outlet opening disposed in the distal region of the main body, and the perfusion fluid enters the perfusion conduit through the inlet opening and exits the perfusion conduit through the outlet opening. The perfusion conduit further defines an inlet opening disposed in the proximal region of the main body and an outlet opening disposed in the distal region of the main body, and the perfusion fluid enters the perfusion conduit through the inlet opening and exits the perfusion conduit through the outlet opening.

[0009] The advantages of the present disclosure will be better understood by referring to the following detailed description when considered in connection with the accompanying drawings, and can be easily understood. The advantages of the present disclosure will be better understood by referring to the following detailed description when considered in connection with the accompanying drawings, and can be easily understood.

Brief Description of the Drawings

[0010]

Fig. 1

Fig. 2

Fig. 3

Fig. 4A

Fig. 4B

Fig. 4C

Fig. 5

Fig. 6

Fig. 7

Fig. 8A

Fig. 8B

[0011] As medical professionals strive to reduce the size of incisions and shorten the recovery time required after invasive medical procedures the size of medical devices used in various medical procedures is decreasing. . Many of the medical devices utilized in performing various medical procedures may include the use of cutting accessories such as ultrasonic tips. When performing cutting, shaving, or shaping operations, the cutting accessories are exposed to various amounts of force, creating stress in the cutting accessories. Many of these cutting accessories may be used to reduce heat and / or remove debris from the surgical site. When performing cutting, shaving, or shaping operations, the cutting accessories are exposed to various amounts of force, creating stress in the cutting accessories.

[0012] Many of these cutting accessories may be used to reduce heat and / or remove debris from the surgical site. may also require the use of washing or suction (i.e., aspiration). Perfusion and / or An example of a surgical instrument that can utilize a suction system is an ultrasonic surgical handpiece. Generally one or more lines may be coupled to the ultrasonic surgical handpiece to supply perfusion and / or suction. The ultrasonic surgical handpiece may include one or more lumens that can be utilized to direct fluid from a perfusion source to the surgical site and / or to a cutting accessory, i.e., an ultrasonic tip. The ultrasonic surgical handpiece may further include a sleeve having one or more lumens that can be utilized to direct fluid from a perfusion source to the surgical site and / or to a cutting accessory, i.e., an ultrasonic tip. One such ultrasonic surgical handpiece is described in PCT / US19 / 52609 entitled "Ultrasonic Surgical Handpiece Assembly" which is incorporated herein by reference in its entirety. However, particularly flat or narrow cutting accessories often do not include lumens throughout their entire length, all the way to the cutting edge or blade. Further, when the current in the cutting accessory becomes high due to the absence of an overall suction or cooling lumen, the handpiece may overheat. The accumulation of excessive heat can potentially affect the lifespan of the handpiece and the surgeon may feel it as well.

[0013] Moreover, the shape and geometry of the cutting accessory can potentially affect the amplification factor or gain associated with the ultrasonic instrument. By configuring the ultrasonic tip with a lower gain in a particular implementation, the inventors have recognized that various advantages can be achieved, including a reduction in stalling, less power consumption to drive the tip, and the ability to drive the tip with a higher current to the ultrasonic. Using the handpiece, the cutting speed can be increased without increasing stalling.

[0014] ​​​​​​​​It can be raised.

[0015] Figures 1 and 2 illustrate a typical configuration of an ultrasonic surgical handpiece assembly 10 that can be utilized by medical professionals to remove biological substances from a patient. The ultrasonic surgical handpiece assembly 10 may include an ultrasonic handpiece 12 that includes a distal housing portion 14 and a proximal housing portion 16. A perfusion sleeve 18 may be removably coupled to the distal housing portion 14 of the ultrasonic surgical handpiece 12. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The ultrasonic handpiece 12 may include a distal housing portion 14 and a proximal housing portion 16, and may be provided with a perfusion sleeve 18 that can be removably coupled to the distal housing portion 14 of the ultrasonic surgical handpiece 12. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 may be removably coupled to the distal housing portion 14 of the ultrasonic surgical handpiece 12. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14. The perfusion sleeve 18 and the ultrasonic tip 20 may be configured such that when both the perfusion sleeve 18 and the ultrasonic tip 20 are coupled to the ultrasonic handpiece 12, the perfusion sleeve 18 surrounds at least a portion of the ultrasonic tip 20 along the length of the ultrasonic tip 20. The perfusion sleeve 18 and the ultrasonic tip 20 may at least partially constitute an ultrasonic sleeve assembly 14.

[0016] Figure 2 shows a cross-sectional view of the ultrasonic surgical handpiece assembly 10 of Figure 1. As shown in Figure 2, the ultrasonic handpiece 12 may include a transducer 22 disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The transducer 22 may include a plurality of piezoelectric elements or magnetostrictive elements configured to generate mechanical energy. As shown in Figure 2, the ultrasonic handpiece 12 may include a transducer 22 disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The transducer 22 may include a plurality of piezoelectric elements or magnetostrictive elements configured to generate mechanical energy. The ultrasonic handpiece 12 may include a transducer 22 disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The transducer 22 may include a plurality of piezoelectric elements or magnetostrictive elements configured to generate mechanical energy. The transducer 22 may include a plurality of piezoelectric elements or magnetostrictive elements configured to generate mechanical energy. The transducer 22 may include a plurality of piezoelectric elements or magnetostrictive elements configured to generate mechanical energy.

[0017] The ultrasonic handpiece 12 may also include a horn 24 that may be at least partially disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The horn 24 may include a distal end and a proximal end. The proximal end of the horn 24 may be coupled to the transducer 22. The ultrasonic handpiece 12 may also include a horn 24 that may be at least partially disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The horn 24 may include a distal end and a proximal end. The proximal end of the horn 24 may be coupled to the transducer 22. The ultrasonic handpiece 12 may also include a horn 24 that may be at least partially disposed within a gap defined by the distal housing portion 14 and the proximal housing portion 16 of the ultrasonic handpiece 12. The horn 24 may include a distal end and a proximal end. The proximal end of the horn 24 may be coupled to the transducer 22. It can be coupled to the distal end of the lance transducer 22. The transducer 22 can be configured to impart mechanical energy generated by a piezoelectric element or a magnetostrictive element to the horn 24. Also, the horn 24 can be configured to define a horn lumen 26 that extends from the proximal end to the distal end of the horn 24. The horn lumen 26 can define a portion of a passage that extends through the ultrasonic handpiece 12 for aspiration. The horn lumen 26 has a distal end and a proximal end, and the proximal end may communicate with an aspiration source 27. The transducer 22 can be coupled to the aspiration source 27 via a coupler 28.

[0018] The ultrasonic handpiece 12 can further include an irrigation line 38 disposed within a gap defined by a distal housing portion 14 and a proximal housing portion 16 of the ultrasonic handpiece 12. The irrigation line 38 can be configured to extend from the proximal end to the distal end of the ultrasonic handpiece 12. The irrigation line 38 can serve to direct a liquid such as water or saline from an irrigation system coupled to the ultrasonic handpiece 12 through an irrigation sleeve 18. The irrigation line 38 can be routed directly from an irrigation source (not shown) to the irrigation sleeve 18 (i.e., the irrigation line 38 does not necessarily always route through the handpiece 12).

[0019] The ultrasonic chip 20 can include a shaft 42 that includes a distal region 44, an intermediate region 46, and a proximal region 48, and all of these regions are disposed along a longitudinal axis L1. Also, the ultrasonic chip 20 can include a coupling mechanism 50 located in the proximal region 48 of the shaft 42, and couple the proximal region 48 of the ultrasonic chip 20 to the distal end of the horn 24, ​​​​​​​​​​​​​​​​ configured to be mechanically communicable with the ultrasonic chip 20. The coupling mechanism 50 may be a threaded coupler 52 configured to engage a corresponding threaded coupler on the distal end of the horn 24. The ultrasonic chip 20 may be screwed into the horn 24 and may be tightened to a predetermined torque specification to removably secure the ultrasonic chip 20 to the ultrasonic handpiece 12. Although not shown in the figures, it is contemplated that the coupling mechanism 50 may be configured as a quick connect, quarter turn fitting, or similar coupling mechanism. Further, it is contemplated that the coupling mechanism 50 may be configured to permanently attach the ultrasonic chip 20 to the handpiece 12. For example, the ultrasonic chip 20 may be coupled to the ultrasonic handpiece 12 by welding, epoxy, or similar attachment methods. Alternatively, it is contemplated that the ultrasonic chip 20 and the horn 24 may be formed as an integral component. In such a configuration, the ultrasonic chip 20 can include a base (horn) 24 for coupling to the transducer 22 and a body composed of a shaft 42 and a cutting portion 40. The bodies 40, 42 extend from the base 24 along the shaft 42 and are coupled to the base 24. The bodies 40, 42 extend from the shaft 42 to the cutting portion 40 along the longitudinal axis L1. In some embodiments, such as the illustrated embodiment, the shaft 42 has no lumen in the distal region 44. In other words, the ultrasonic chip may have no lumen in the portion of the cutting chip characterized by a rectangular cross-sectional area. The shaft 42 may be made of a metal such as a titanium alloy, stainless steel, etc., depending on the application.

[0020]

[0021] In some embodiments, such as the illustrated embodiment, the shaft 42 has no lumen in the distal region 44. In other words, the ultrasonic chip may have no lumen in the portion of the cutting chip characterized by a rectangular cross-sectional area. The shaft 42 may be made of a metal such as a titanium alloy, stainless steel, etc., depending on the application. ​​​​​​​​​​It may be formed of a non-metallic material such as a metal material or a composite material. In one aspect, the shaft 42 and the cutting portion 40 may be integral, unitary, and a single component. In other aspects the cutting portion 40 of the ultrasonic chip 20 may be attached to the shaft 42 by a suitable mechanism such as a screw (not shown).

[0022] FIG. 3 shows a top view of a typical configuration of a perfusion sleeve 18 having a distal region 58 and a proximal region 60. The perfusion sleeve 18 may include a perfusion sleeve coupling mechanism 62 on the proximal region 60 of the perfusion sleeve 18. The perfusion sleeve coupling mechanism 62 may include one or more fingers 64 extending proximally from the proximal region 60 of the perfusion sleeve 18. Each of the one or more fingers 64 may include a tab 66 extending in a radially outward direction with respect to the longitudinal axis L1 of the perfusion sleeve 18. The fingers 64 function as male attachments configured to engage with a female attachment (not shown) on the ultrasonic handpiece 12 to form a snap fit or an interference fit. It is contemplated that other types of perfusion sleeve coupling mechanisms 62 may be used to couple the perfusion sleeve 18 to the ultrasonic handpiece 12. By way of example and not limitation, the perfusion sleeve coupling mechanism 62 may be configured as a screw connection. It should be understood that the perfusion sleeve 18 described herein may be used in combination with other chip configurations other than those shown herein.

[0023] Referring now to FIG. 4A, an exploded view of an ultrasonic chip and perfusion sleeve assembly 68 is shown. The perfusion sleeve assembly 68 includes a perfusion sleeve 18 defining a lumen 70 extending along a longitudinal axis L1. The perfusion sleeve 18 includes a sleeve body defining a helical groove 74. can have 72. In the assembled form, when the ultrasonic chip 20 is inserted into the perfusion sleeve 18, the perfusion sleeve 18 can at least partially surround the shaft 42 of the ultrasonic chip 20 when the ultrasonic chip 20 is placed within the lumen 70 of the perfusion sleeve 18 and the perfusion sleeve 18 is coupled to the handpiece.

[0024] The perfusion sleeve assembly 68 can further include a sheath 76 having proximal and distal ends corresponding to the proximal region 60 and distal region 58 of the perfusion sleeve 18, respectively. The sheath 76 can be coupled to at least a portion of the sleeve body 72 so as to surround at least one full rotation of the helical groove 74 and be disposed over at least a portion of the sleeve body 72, although it may optionally surround more than two or three rotations of the helical groove for sufficient retention.

[0025] The position of the helical groove 74 may vary if the chips are different. By way of non-limiting example, in some configurations, one ultrasonic chip can define a groove located a first distance from the chip coupler (e.g., coupling mechanism 50) of the chip, while a different ultrasonic chip can define a groove located a second distance from the chip coupler (e.g., coupling mechanism 50) of the chip. In some configurations, the first distance is different from the second distance. This is beneficial because the positions of the nodes and bellies may vary if the chips are different. It can be useful to align the seal member with a node or belly of a particular chip.

[0026] Referring to FIG. 5, the perfusion sleeve assembly of FIG. 3 in the assembled form with the chip inserted​​​​​​​​​​ A cross-sectional view of the perfusion sleeve 68 is shown. The assembled perfusion sleeve with the ultrasonic chip 20 inserted therethrough The perfusion sleeve assembly 68 shows the ultrasonic chip 20 disposed within the lumen 70 such that the perfusion sleeve 18 partially surrounds the shaft 42.

[0027] Referring now to FIG. 6, a partial cross-sectional view of the ultrasonic chip 20, perfusion sleeve 18, sheath 76, and perfusion conduit 78 of the perfusion sleeve assembly of FIG. 5 is shown. The sheath 76 is at least partially disposed over the perfusion sleeve 18 so as to cover the perfusion conduit 78 surrounding at least one full revolution of the helical groove 74.

[0028] In some configurations, the sleeve body 72 can define a second helical groove 96. The second helical groove 96 may or may not have the perfusion conduit 78 and may be partially surrounded by the sheath 76, i.e., one or more revolutions of the second helical groove 96 may be surrounded by the sheath 76.

[0029] The sheath 76 can be made of a heat-shrinkable material or other suitable material that can be deformed to conform to the shape of the perfusion conduit 78 and the contour below the sleeve body 72 including the second helical groove 96. When the sheath 76 is contoured to the second helical groove 96, the sheath can define undulations 98 useful for a user to grasp.

[0030] Referring again to FIG. 4A, the perfusion sleeve assembly 68 can further include a perfusion conduit 78 disposed within the helical groove 74 for carrying a perfusion fluid. The perfusion conduit 78 can be in fluid communication with or adjacent to the lumen 70 and can be connected to a liquid source (not shown). ​​​​​​​​​​​​It can continue. The perfusion conduit 78 has an inlet opening 80 (which is disposed in the proximal region 60 of the sleeve body 72 when the perfusion sleeve assembly 68 is in the assembled configuration) and an outlet opening 8 2 (which is disposed in the distal region 58 of the sleeve body 72 when the perfusion sleeve assembly 68 is in the assembled configuration). The perfusion fluid can enter the perfusion conduit 78 at the inlet opening 80 and exit the perfusion conduit 78 at the outlet opening 8 2. In some configurations, the perfusion conduit 7 8 can comprise a single member that defines a continuous length between the inlet opening 80 and the outlet opening 82. The perfusion conduit 78 can be configured to couple directly to a corresponding port of the surgical handpiece 12, and thus the perfusion conduit 78 may comprise a flexible material. In other words, the perfusion conduit 78 may be formed from a material that can be deformed such that the inlet opening 80 can partially wrap around a corresponding port of the ultrasonic handpiece 12 to form a connection to the perfusion source. The helical shape of the groove 74 causes the perfusion conduit 78 to have a similar helical shape. The helical perfusion conduit 78 (tube ) and the groove 74 provide a longer fluid return path than a straight return path. This longer path makes it more difficult for the fluid to move backward in the proximal direction after the fluid has first been carried through the perfusion conduit 78. After the fluid has been carried distally along the sleeve body 72 through the perfusion conduit 78, the fluid can exit the perfusion conduit 78 at the outlet opening 82. From there, the fluid can spread across the surface of the sleeve body 72 and / or the shaft 42. Depending on the situation, the fluid may return to the opening 83 and flow backward through the perfusion conduit 78. Otherwise, the fluid flows in the path between the outer diameter of the perfusion conduit 78 within the sheath 7 6 and the inner surface of the sleeve body 72 across the sleeve body The perfusion conduit 78 may be formed from a material that can be deformed such that the inlet opening 80 can partially wrap around a corresponding port of the ultrasonic handpiece 12 to form a connection to the perfusion source. The helical shape of the groove 74 causes the perfusion conduit 78 to have a similar helical shape. The helical perfusion conduit 78 (tube ) and the groove 74 provide a longer fluid return path than a straight return path. This longer path makes it more difficult for the fluid to move backward in the proximal direction after the fluid has first been carried through the perfusion conduit 78. After the fluid has been carried distally along the sleeve body 72 through the perfusion conduit 78, the fluid can exit the perfusion conduit 78 at the outlet opening 82. From there, the fluid can spread across the surface of the sleeve body 72 and / or the shaft 42. Depending on the situation, the fluid may return to the opening 83 and flow backward through the perfusion conduit 78. Otherwise, the fluid flows in the path between the outer diameter of the perfusion conduit 78 within the sheath 7 The perfusion conduit 78 may be formed from a material that can be deformed such that the inlet opening 80 can partially wrap around a corresponding port of the ultrasonic handpiece 12 to form a connection to the perfusion source. The helical shape of the groove 74 causes the perfusion conduit 78 to have a similar helical shape. The helical perfusion conduit 78 (tube ) and the groove 74 provide a longer fluid return path than a straight return path. This longer path makes it more difficult for the fluid to move backward in the proximal direction after the fluid has first been carried through the perfusion conduit 78. After the fluid has been carried distally along the sleeve body 72 through the perfusion conduit 78, the fluid can exit the perfusion conduit 78 at the outlet opening 82. From there, the fluid can spread across the surface of the sleeve body 72 and / or the shaft 42. Depending on the situation, the fluid may return to the opening 83 and flow backward through the perfusion conduit 78. Otherwise, the fluid flows in the path between the outer diameter of the perfusion conduit 78 within the sheath 7 It is more difficult for the fluid to move backward in the proximal direction after the fluid has first been carried through the perfusion conduit 78.

[0031] After the fluid has been carried distally along the sleeve body 72 through the perfusion conduit 78, the fluid can exit the perfusion conduit 78 at the outlet opening 82. From there, the fluid can spread across the surface of the sleeve body 72 and / or the shaft 42. Depending on the situation, the fluid may return to the opening 83 and flow backward through the perfusion conduit 78. Otherwise, the fluid flows in the path between the outer diameter of the perfusion conduit 78 within the sheath 7 6 and the inner surface of the sleeve body 72 across the sleeve body 6 and the inner surface of the sleeve body 72 across the sleeve body 6 and the inner surface of the sleeve body 72 across the sleeve body 6 and the inner surface of the sleeve body 72 across the sleeve body It may return proximally along 72.

[0032] One of the perfusion sleeve 18 and the ultrasonic chip 20 may include a seal member 86. The seal member 86 may be an annular seal member including, by way of example and not limitation, an O-ring. In some configurations, the seal member 86 may be coupled to the chip 20. In such an implementation, the seal member 86 is positioned around a groove 88 defined on the outer surface of the chip 20. As a result, the seal member 86 is positioned between the outer surface of the ultrasonic chip 20 and the inner surface of the lumen 70, and can prevent the movement of fluid from the outlet opening 82 to the proximal side of the seal member 86. Alternatively, the seal member 86 may be coupled to the sleeve 18, and in this case, it may also be positioned to engage the outer surface of the chip 20 in order to prevent the movement of fluid from the outlet opening 82 to the proximal side of the seal member 86 as before.

[0033] The seal member 86 can also be used to attenuate the amplitude of the vibration of the ultrasonic chip 20. The amplitude of the vibration at any point along the ultrasonic chip 20 may depend on the position along the ultrasonic chip 20 where the vibration is measured. The points along the standing wave where the amplitude of the wave is minimized are generally called nodes. At the nodes, generally, the vibratory motion is minimized. Since the seal member 86 can be directly coupled to the chip 20, it can be placed anywhere on the ultrasonic chip 20 to reduce the lateral movement of the chip 20. In some configurations, it may be appropriate to place the seal member 86 at or near a node of the chip 20. The position of the node may vary for different ultrasonic chips.

[0034] Furthermore, since the seal member 86 can be directly coupled to the chip 20, while positioning the sleeve assembly across the ultrasonic chip 20, the sharp surface of the ultrasonic chip 20 will never contact the seal member 86. Therefore, the seal member 86 is protected from wear and other damage when the ultrasonic chip 20 is positioned across the sleeve 18. By disposing the seal member 86 on the ultrasonic chip 20 rather than on the perfusion sleeve 18, it is also prevented that the seal member 86 slips off naturally or disengages from the perfusion sleeve assembly 68.

[0035] Referring now to FIG. 7, another cross-sectional view of the perfusion sleeve assembly with the chip of FIG. 3 inserted therein in an assembled configuration is shown. The ultrasonic chip 20 can define a first hole 90 that functions as an air inlet. This first hole 90 can be positioned proximal to the seal member 86 when the perfusion sleeve assembly 68 including the ultrasonic chip 20 is coupled to the handpiece 12. In some configurations, the first hole 90 is positioned distal to the seal member 86. A second hole 92 can extend from the proximal region 48 of the shaft 42 to the first hole 90 through the threaded coupler 52. In other words, the first hole 90 and the second hole 92 are positioned such that they are in fluid communication with each other with the first hole 90 transverse to the longitudinal axis L1 of the ultrasonic chip 20, and the second hole 92 is concentric with the longitudinal axis L1 of the chip 20. In one example, the axis N1 of the first hole 90 can be perpendicular to the axis N2 of the second hole 92. In some configurations, the first hole 90 can comprise a single hole. In other configurations such as the configuration shown in FIG. 7, the first hole 90 extends laterally from one side of the ultrasonic chip 20 to the other side, and a second hole 92 is provided on both sides of the ultrasonic chip 20. hole 92 is concentric with the longitudinal axis L1 of the chip 20. In one example, the axis N1 of the first hole 90 can be perpendicular to the axis N2 of the second hole 92. In some configurations, the first hole 90 can comprise a single hole. In other configurations such as the configuration shown in FIG. 7, the first hole 90 extends laterally from one side of the ultrasonic chip 20 to the other side, and a second hole 92 is provided on both sides of the ultrasonic chip 20. hole 92 is provided on both sides of the ultrasonic chip 20. In one example, the axis N1 of the first hole 90 can be The hole 90 of 1 can be formed. However, in other configurations, a plurality of first holes 90 may be included in the ultrasonic chip 20, and each of the plurality of first holes 90 does not form a single channel with the second hole 92 at each end as shown in FIG. 7, but is separate from each other (however, each may still communicate with the second hole 92). Further more, as long as the first hole 90 extends from the outermost periphery to the second hole 92, the first hole 90 does not need to extend through the chip 2 0 to the end. When a plurality of paths are defined from the outer periphery of the ultrasonic chip 20 to the second hole 92, these holes can be arranged in various ways, such as being arranged circumferentially around the surface of the chip 20. 0. When the perfusion sleeve assembly 68 including the ultrasonic chip 20 is coupled to the handpiece in some configurations, the perfusion sleeve assembly 68 further includes a third hole 9 4 on the proximal side of the first hole 90. More specifically, the sleeve body 72 can define a third hole 94 to further facilitate the entry of air from the surrounding environment into the first hole 90. Of course, it is considered that the perfusion sleeve assembly 68 can include a plurality of third holes 94 that define an opening that allows ambient air to move from the outside of the perfusion sleeve assembly 68 to the first hole 90 when the suction source 2

[0036] 7 is coupled to the chip 20. In the illustrated configuration, the inlet opening 80, the outlet opening 82, the first hole 90, the second hole 92, and the third hole 94 all have a circular cross-sectional shape. However, in some configurations, all of the inlet opening 80, the outlet opening 82, the first hole 90, the second hole 92, and / or the third hole 94 may have a non-circular cross-sectional shape. In the illustrated configuration, the perfusion sleeve assembly 68 can include a plurality of third holes 94 that define an opening that allows ambient air to move from the outside of the perfusion sleeve assembly 68 to the first hole 90 when the suction source 2 7 is coupled to the chip 20 so that the ambient air can move from the outside of the perfusion sleeve assembly 68 to the first hole 90.

[0037] In the illustrated configuration, the inlet opening 80, the outlet opening 82, the first hole 90, the second hole 92, and the third hole 94 all have a circular cross-sectional shape. However, in some configurations, all of the inlet opening 80, the outlet opening 82, the first hole 90, the second hole 92, and / or the third hole 94 Alternatively, any combination may have a shape other than circular, such as various polygons and ellipses.

[0038] The perfusion sleeve 18 may be formed from any polymer, such as a thermoplastic. The distal region 58 of the perfusion sleeve 18 may have a part of a frangible portion that can be severed or cut off to change the length of the perfusion sleeve 18.

[0039] Referring again to FIG. 5, when the perfusion sleeve assembly 68 is coupled to a perfusion source by a coupler such as the perfusion line 38, the perfusion sleeve assembly can draw in perfusate through the inlet opening 80 from the perfusion source. The perfusion conduit 78 can then convey the perfusate from the inlet opening 80 to the outlet opening 82. The conveyance of the perfusate through the perfusion sleeve assembly 68 helps to cool the shaft 42 of the ultrasonic chip 20. Furthermore, the conveyance of the perfusate through the perfusion sleeve assembly 68 can help prevent the perfusion sleeve 18 from deforming or melting due to excessive heat generated by the movement of ultrasonic cutting.

[0040] Furthermore, when the perfusion sleeve assembly 68 including the ultrasonic chip 20 is coupled to the handpiece 12, the ultrasonic chip 20 draws in air through the third hole 94 and then returns it through the first hole 90 to the second hole 92 and finally draws it out through the coupler 28. This movement of air helps to cool the chip in the region near the seal member 86 that is prone to overheating due to frictional heat generated by the relative movement between the seal member 86 and the perfusion sleeve assembly 68.

[0041] Furthermore, the suction of air through the chip and / or sleeve can serve as a smoke exhaust device depending on the application. It can also operate. In the illustrated configuration, the ultrasonic chip 20, compared to other procedures generates a large amount of smoke, dust particles, and floating debris during lumbar procedures and other relatively "strenuous" bone cutting procedures. The air suction function can suck a part of the air around the ultrasonic handpiece 12 and discharge it through the handpiece 12. The device can be used in combination with a smoke filter to remove these fine particles from the ambient air after being sucked through the chip 20.

[0042] Referring now to FIGS. 8A - 8B, top and side views of the distal portion of the ultrasonic chip including the cutting head are shown. The ultrasonic chip 20 can include a first side surface 100 that is substantially planar. The ultrasonic chip 20 can further include a second side surface 102 that is substantially planar and is disposed on the opposite side of the first side surface 100. The ultrasonic chip 20 can further include a cutting head (also referred to herein as a "cutting portion") 104 that is disposed on the distal side of the shaft 42. The cutting head 104 can include a base portion 106 having a lateral dimension T1 between the first side surface 100 and the second side surface 102. The lateral dimension T1 can extend perpendicular to the longitudinal axis L1 of the cutting head 104. The cutting head 104 can further include a tapered portion 108 having a chamfered portion that extends from the base portion 106 to the cutting edge 110. By way of non - limiting example, in a preferred configuration, the base portion 106 has a lateral dimension of at least 7.975 millimeters. All of U.S. Patent Nos. 6,723,110, 6,497,715, D55176, which are hereby incorporated by reference in their entirety herein Cutting as described in this application, such as that shown in No. 4 and No. 6955680 It should be understood that other ultrasonic chips, such as those without the perfusion sleeve assembly head features described above, can be used together with the perfusion sleeve assembly Similarly, the ultrasonic chip can be used together with other perfusion sleeve assemblies, such as those shown in PCT / US2019 / 052609, which is incorporated herein by reference in its entirety It should be understood that it can be used together with other perfusion sleeve assemblies

[0043] The cutting edge 110 has a certain length and may have a U-shaped profile with a first leg 112, a second leg 11 4, and an arcuate distal portion 116. By way of non-limiting example, in a preferred configuration, the arcuate distal portion 116 has a thickness of at least 1.35 millimeters The first leg 112 and the second leg 114 may be parallel to each other and each may be provided with a plurality of cutting teeth, one of which is labeled 118. In some configurations, less than half of the length of the cutting edge 110 may have cutting teeth 118. In other configurations a length greater than half of the length of the cutting edge 110 may have cutting teeth 118 In some configurations, as shown in the configuration shown in FIGS. 8A-8B, the arcuate distal portion 116 has no cutting teeth 118

[0044] The cutting portion 40 defines a center line 120 along the longitudinal axis L1. Further, the plurality of cutting teeth 118 comprise at least two adjacent cutting teeth 118 and a notch 122 between each adjacent cutting tooth 118 The notch 122 has a transverse dimension T 2 along the notch base 124. Each cutting tooth 118 has a tooth cutting edge 126. In some configurations, the notch ​​The lateral dimension T2 of the ki 122 is at least 1 / 25 of the lateral dimension T1 of the base portion 106.

[0045] The distance from the center line 120 to the tooth cutting edge 126 defines a first distance A1. The center line 120 to the notch base 124 defines a second distance A2. The distance from the center line 120 to the starting point of the tapered portion 108 defines a third distance A3. In some configurations, the difference between the first distance A1 and the second distance A2 is 0.25 mm or less. In some configurations, the first distance A 1 is greater than 1.5 times the third distance A3 but less than 2 times the third distance A3. In the illustrated example, without limitation, the first distance A1 is 3.4 mm, the second distance A2 is 3.15 mm, and the third distance A3 is 1.85 mm. In this example, the difference between the first distance A1 and the second distance A2 is exactly 0.25 mm. Also, in this example, the first distance A 1 is approximately 1.837 times greater than the third distance A3.

[0046] The ultrasonic chip 20 can be useful for cutting both hard and soft tissues. The tooth cutting edge 126 enables cutting of hard tissues such as cortical bone. The serrated tooth cutting edge 126 can perform a saw-like operation to cut through denser tissues. In contrast, the cutting edge 110 is a smooth continuous blade. However, while it may be sharp enough to cut hard tissues, it may be sufficiently blunt compared to the soft tissues it contacts to be non-traumatic. Without limitation, as an example, the thickness of the cutting edge 110 may be 0.2 m m + / - 0.05 mm. Thus, the cutting edge 110 can contact soft tissues while minimizing the risk of perforating important structures such as the spinal cord. outside The surgeon can feel a tactile change when the cutting edge 110 moves between different tissue structures due to the natural difference in density between hard and soft tissues and indicates that the cutting should be terminated when the cutting edge 110 reaches the soft tissue. Therefore, the ultrasonic tip 20 can cut the hard bone structure with both its tooth edge 126 and cutting edge 110 while avoiding trauma to the underlying soft tissue, giving it an advantage over conventional sharp bone cutting blades. structure.

[0047] Referring back to FIGS. 4A - 4C, different points along the shaft 42 have different cross - sectional areas. The transducer and the ultrasonic tip are generally designed to have the same resonance frequency in a longitudinal resonance device, but due to the decrease in cross - sectional area along the length of the ultrasonic tip, the vibration velocity at the output surface of the transducer may be amplified. The amplification factor, also called the gain is determined by the decrease in cross - sectional area and the shape of the ultrasonic tip. The gain can be measured by dividing the chip displacement by the horn piece displacement.

[0048] In the illustrated configuration, the cross - sectional area of the first slice SL1 is defined as the maximum circular cross - sectional area of the ultrasonic tip 20 and defines a plane perpendicular to the longitudinal axis L1. FIG. 4B shows a cross - sectional view of the ultrasonic tip of FIG. 4A at the first cross - sectional area. The cross - sectional area of the second slice SL2 is defined at a position 20 mm proximal to the distal end of the tip. The second slice SL2 defines a plane perpendicular to the longitudinal axis L1 and the second slice SL2 is distal to the first slice SL1. FIG 4C shows a cross - sectional view of the ultrasonic tip of FIG. 4A at the second slice.

[0049] The cross - sectional area of the second slice SL2 is one - fifth to one - sixth of the cross - sectional area of the first slice SL1. ​​​​​​​​​That is to say, the cross-sectional area of the second slice SL2 is 13 - 25, 15 - 21, 16 - 20, or 16.7 - 20% of the cross-sectional area of the first slice SL1. As a result, the gain of the ultrasonic chip becomes low. Since the gain of the ultrasonic chip 20 calculated by dividing the displacement of the ultrasonic chip 20 by the displacement of the ultrasonic handpiece 12 is low, the stall of the cutting part 40 (for example, the cutting head 104) is reduced, and the performance of the entire ultrasonic chip 20 is improved. (For example, the cutting head 104) The stall is reduced, and the performance of the entire ultrasonic chip 20 is improved. In addition, the power consumed to drive the ultrasonic chip 20 is reduced, and the ultrasonic chip 20 can be driven with a higher current, so that the cutting speed can be improved without increasing the stall of the cutting part 40 (for example, the cutting head 104).

[0050] For example, but not limited to, in the illustrated configuration, the diameter of the first slice SL1 is 8 mm, and the diameter of the gun drill hole is about 2 mm. In this configuration, the cross-sectional area of the first slice SL 1 is about 47.1 mm 2 In some configurations, the cross-sectional area of the second slice SL2 can be about 8.725 mm 2 Therefore, in this configuration, the value of the cross-sectional area of the second slice SL2 is about one fifty-fourth of the value of the cross-sectional area of the first slice SL1.

[0051] In the illustrated configuration, the gain of the ultrasonic chip 20 is about 3. The ultrasonic chip 20 should be understood to be able to show gains in the range of 2 - 5, 2 - 4, 2.5 - 3.5, and 2.75 - 3.25. Alternatively, the gain shown by the ultrasonic chip 20 may be less than 5. For comparison, similar ultrasonic waves known in the art used for similar applications should be understood. The chip has a gain of about 7.0 to 7.4. The gain of the ultrasonic chip 20, which is calculated by dividing the displacement of the ultrasonic chip 20 by the displacement of the ultrasonic hand piece 12, is low. As a result, the stall of the cutting part 40 (for example, the cutting head 104) is reduced, and the overall performance of the ultrasonic chip 20 is improved. In addition, the power consumed to drive the ultrasonic chip 20 is reduced , and it becomes possible to drive the ultrasonic chip 20 with a higher current. Thereby, without increasing the stall of the cutting part 4 0 (for example, the cutting head 104), the cutting speed can be improved.

[0052] The gain can also be achieved by a uniform outer surface, and the entire content of this is incorporated herein by reference in the specification of the US Patent entitled "Ultrasonic Torsional Tissue Di ssection Utilizing Subaltern Modes of Lo ngitudinal-Torsional Resonators", No. 9,962,183, and is composed of two different materials arranged vertically with respect to each other as described.

[0053] The ultrasonic chip 20 may not have a mechanism for converting longitudinal to torsional motion, and thus may be configured to vibrate only in the longitudinal direction. The ultrasonic chip 20 may be composed of titanium.

[0054] The perfusion sleeve 18 described in this specification can be used with any type of ultrasonic chip. In other words, the perfusion sleeve 18 described in this specification can be used with an ultrasonic chip that does not include the described first and second holes 90, 92. Further, as described in this specification The perfusion sleeve 18 described above has no cutting head with two substantially flat sides and can be used with an ultrasonic chip. For example, the perfusion sleeve 18 described herein can be used with an ultrasonic chip having a cylindrical shape and depending on longitudinal, torsional, or both longitudinal and torsional movements, as described in U.S. Patent Application Publication No. 2005 / 0177184, U.S. Patent No. 8,512,340, and U.S. Patent Application Publication No. 2008 / 0 208231, each of which is incorporated herein by reference in its entirety.

[0055] The apparatus described herein can be used with any chip configuration and / or any perfusion sleeve configuration described herein.

[0056] Items regarding further protection: I. An ultrasonic chip comprising a shaft and a cutting portion, the ultrasonic chip having: a first side that is substantially planar and extends from a proximal end to a distal end; a second side that is substantially planar, is disposed opposite the first side, and extends from the proximal end to the distal end; a cutting head disposed at the distal end; a first hole that defines an air inlet disposed proximal to the cutting head; and a second hole that extends from the proximal end of the shaft to the first hole. II. The ultrasonic chip of item I, wherein the cutting head has a base portion having a lateral dimension between the first side and the second side, the lateral dimension extends perpendicular to the longitudinal axis of the cutting head, and a tapered portion, together with a chamfered portion, extends from the base portion to the cutting edge, the cutting edge has a length and has a U-shaped profile having a first leg, a second leg, and an arcuate distal portion, and the first leg and the second leg are parallel to each other. ​​​​​​ III. The cross-sectional area of the first slice of the maximum circular cross-sectional area of the shaft defines a plane perpendicular to the longitudinal axis and the cross-sectional area of the second slice of smaller cross-sectional area in the proximal region of the shaft defines a plane perpendicular to the longitudinal axis and the value of the cross-sectional area of the second slice is one fifty-fourth of the value of the cross-sectional area of the first slice. The ultrasonic chip of item I or II. IV. Further comprising an ultrasonic device having a proximal region and a distal region, the ultrasonic device 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, and the transducer is coupled to a suction source by a first coupler and the ultrasonic chip is coupled to the horn. The ultrasonic chip of item I, II, or III. The ultrasonic chip of item I, II, or III. V. A perfusion sleeve, the perfusion sleeve comprising a body having a distal region and a proximal region and defining a spiral groove that at least partially surrounds the shaft of the chip when the chip is within the lumen of the sleeve and further comprising a sheath coupled to a portion of the body so as to surround at least one full revolution of the spiral groove and disposed across a portion of the body and having a distal end opposite the proximal end and a perfusion conduit disposed within the spiral groove for carrying a perfusion fluid and the perfusion conduit further defines an inlet opening disposed in the proximal region of the body and an outlet opening disposed in the distal region of the body, and the perfusion fluid enters the perfusion conduit at the inlet opening and exits the perfusion conduit at the outlet opening. The ultrasonic chip of item I, II, III, or IV. The perfusion conduit further defines an inlet opening disposed in the proximal region of the body and an outlet opening disposed in the distal region of the body, and the perfusion fluid enters the perfusion conduit at the inlet opening and exits the perfusion conduit at the outlet opening. The ultrasonic chip of item I, II, III, or IV. The perfusion conduit further defines an inlet opening disposed in the proximal region of the body and an outlet opening disposed in the distal region of the body, and the perfusion fluid enters the perfusion conduit at the inlet opening and exits the perfusion conduit at the outlet opening. The ultrasonic chip of item I, II, III, or IV. VI. An ultrasonic chip comprising a shaft defining a longitudinal axis and a cutting portion, wherein the ultrasonic chip defines a first substantially planar side surface and a second substantially planar side surface, and the cutting portion further includes a cutting head, the cutting head includes a cutting edge, the maximum cross-sectional area of the chip defines the cross-sectional area of a first slice, the cross-sectional area of a second slice is defined at a position 20 mm proximal to the distal end of the chip, the second slice and the first slice are each perpendicular to the longitudinal axis of the shaft, and the cross-sectional area of the second slice is 15-20% of the cross-sectional area of the first slice. Further, in a specific configuration, the maximum cross-section of the chip feature extends over at least 20 mm in length. In other words, there is a chip portion having a constant cross-sectional area and equal to the maximum cross-sectional area of the chip. Further, it should be understood that in some cases, the diameter of the chip may be 9 mm or less in order to optimally cut delicate bones. The ultrasonic chip defines a first substantially planar side surface and a second substantially planar side surface, and the cutting portion further includes a cutting head, the cutting head includes a cutting edge, the maximum cross-sectional area of the chip defines the cross-sectional area of a first slice, the cross-sectional area of a second slice is defined at a position 20 mm proximal to the distal end of the chip, the second slice and the first slice are each perpendicular to the longitudinal axis of the shaft, and the cross-sectional area of the second slice is 15-20% of the cross-sectional area of the first slice. Further, in a specific configuration, the maximum cross-section of the chip feature extends over at least 20 mm in length. In other words, there is a chip portion having a constant cross-sectional area and equal to the maximum cross-sectional area of the chip. Further, it should be understood that in some cases, the diameter of the chip may be 9 mm or less in order to optimally cut delicate bones. VII. An ultrasonic chip comprising a shaft defining a longitudinal axis and a cutting portion, wherein the ultrasonic chip defines a first substantially planar side surface and a second substantially planar side surface, and the cutting portion further includes a cutting head, the cutting head includes a cutting edge, the maximum cross-sectional area of the chip defines the cross-sectional area of a first slice, the cross-sectional area of a second slice is defined at a position 20 mm proximal to the distal end of the chip, the second slice and the first slice are each perpendicular to the longitudinal axis of the shaft, and the cross-sectional area of the second slice is 1 / 5-1 / 6 of the cross-sectional area of the first slice. Further, in a specific configuration, the maximum cross-section of the chip feature extends over at least 20 mm in length.

[0057] In the above description, several configurations have been described. However, the configurations discussed in this specification It is not intended to be comprehensive or to limit the present invention to a particular form. . For example, in the configuration example, the surgical instrument is described as an ultrasonic handpiece, but the features and concepts described for the ultrasonic handpiece can also be applied to other medical instruments or surgical instruments. This is also intended for ultrasonic tips that further include, for example, blades, drill bits, rotary bars, open window shavers, and the like. The terms used are not for the purpose of limitation but for the purpose of explanation. In light of the above teachings, many modifications and variations are possible, and the present invention can be implemented in ways other than those specifically described. This also applies to ultrasonic tips that further include, for example, blades, drill bits, rotary bars, open window shavers, and the like. The terms used are not for the purpose of limitation but for the purpose of explanation. In light of the above teachings, many modifications and variations are possible, and the present invention can be implemented in ways other than those specifically described. many modifications and variations are possible, and the present invention can be practiced otherwise than as specifically described. This is also intended for ultrasonic tips that further include, for example, blades, drill bits, rotary bars, open window shavers, and the like. The terms used are not for the purpose of limitation but for the purpose of explanation. In light of the above teachings,

Claims

1. An ultrasonic chip comprising a shaft and a cutting portion, a first substantially planar side surface extending from a proximal end to a distal end, substantially planar and disposed on the opposite side of the first side surface, from the proximal end a second side surface extending to the distal end, comprising, the cutting portion includes a cutting head disposed at the distal end, the ultrasonic chip is removably coupled to a horn, and the shaft further comprises a longitudinal axis an ultrasonic chip, a perfusion sleeve having a distal region and a proximal region and defining a lumen extending along the longitudinal axis, surrounding at least a portion of the shaft and defining an inlet opening, the perfusion the sleeve further comprises a first conduit in fluid communication with the lumen, the first conduit having an outlet an opening, and the first conduit is configured to be connected to a liquid source, a perfusion sleeve, an ultrasonic surgical assembly for air-cooling the ultrasonic chip, comprising: the ultrasonic chip further comprises a seal member coupled to an outer surface of the ultrasonic chip, the ultrasonic chip, a first hole defining an air inlet disposed proximal to the seal member, a second hole extending from a proximal end of the shaft to the first hole and forming a fluid path between the first a hole and the second hole, defining, an ultrasonic surgical assembly.

2. further comprising an ultrasonic instrument configured to couple to the ultrasonic chip and the perfusion sleeve, the perfusion sleeve further comprises a third hole proximal to the first hole when the perfusion sleeve and the ultrasonic chip are coupled to the ultrasonic instrument, The ultrasonic surgical assembly according to claim 1.

3. The ultrasonic chip further defines a groove, and the seal member is disposed around the groove, The ultrasonic surgical assembly according to claim 1 or 2.

4. The first hole is perpendicular to the axis of the second hole, The ultrasonic surgical assembly according to claim 1 or 2.

5. The ultrasonic chip, further comprises a base for coupling to a transducer and a body extending from the base, the body comprises the shaft and the cutting portion, the body is coupled to the base by the shaft, the body extends from the shaft to the cutting portion along the longitudinal axis, the cutting head comprises a base portion and a tapered portion, The ultrasonic surgical assembly according to claim 1.

6. ​ The base portion has a lateral dimension between the first side surface and the second side surface, and the lateral dimension extends perpendicular to the longitudinal axis, The tapered portion includes a chamfered portion and extends from the base portion to the cutting edge , the cutting edge has a certain length and has a U-shaped contour having a first leg portion, a second leg portion, and an arcuate distal portion, the first leg portion and the second leg portion are parallel to each other and each includes a plurality of cutting teeth, and less than half of the length of the cutting edge has the plurality of cutting teeth at the distal end, and the arcuate distal portion does not have the plurality of cutting teeth, The ultrasonic surgical assembly according to claim 5.

7. The shaft of the ultrasonic chip does not have a lumen at the distal end, according to any one of claims 1, 2, 5, and 6, the ultrasonic surgical assembly.

8. An ultrasonic instrument, 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 instrument comprising, An ultrasonic chip having a shaft and removably coupled to the horn, An irrigation sleeve defining a lumen, A body releasably coupled to the distal portion of the housing and having a distal region and a proximal region, A body defining a helical groove that at least partially surrounds the shaft of the ultrasonic chip when the ultrasonic chip is within the lumen of the irrigation sleeve, A sheath coupled to a portion of the body so as to surround at least one full rotation of the helical groove and disposed across a portion of the body, having a distal end opposite the proximal end, An irrigation conduit disposed within the helical groove for carrying irrigation fluid, Comprising, The irrigation conduit defines an inlet opening disposed in the proximal region of the body and an outlet opening disposed in the distal region of the body, and the irrigation fluid enters the whole blood irrigation conduit at the inlet opening and exits the irrigation conduit at the outlet opening, the irrigation sleeve.

9. Further comprising an annular seal member disposed in the proximal region of the body and coupled to the outer surface of the ultrasonic chip, the annular seal member being positioned between the outer surface of the ultrasonic chip and the inner surface of the lumen, and the annular seal member preventing fluid from moving proximally

10. The ultrasonic surgical assembly according to claim 9, wherein the annular seal member is made of a material selected from the group consisting of a fluoropolymer, a silicone rubber, and a polyurethane.

11. The ultrasonic surgical assembly according to claim 9, wherein the annular seal member is made of a material selected from the group consisting of a fluoropolymer, a silicone rubber, and a polyurethane.

12. The ultrasonic surgical assembly according to claim 9, wherein the annular seal member is made of a material selected from the group consisting of a fluoropolymer, a silicone rubber, and a polyurethane. The ultrasonic surgical assembly according to claim 8, configured to prevent movement.

10. The body defines a second helical groove that is free of the perfusion conduit and is surrounded by the sheath, and the second helical groove covered by the sheath defines a gripping surface for the user. The ultrasonic surgical assembly according to claim 8 or 9.

11. The perfusion conduit comprises a flexible material, and the perfusion conduit comprises a single member defining a continuous length between the inlet opening and the outlet opening. The ultrasonic surgical assembly according to claim 8 or 9.

12. An ultrasonic chip, comprising: a shaft defining a longitudinal axis; a cutting portion defining a first substantially planar side surface and a second substantially planar side surface, further comprising a cutting head, the cutting head having: a base portion having a lateral dimension between the first side surface and the second side surface, the lateral dimension extending perpendicular to the longitudinal axis of the cutting head; a tapered portion comprising a chamfered portion and extending from the base portion to a cutting edge, the cutting edge having a length and a U-shaped profile having a first leg, a second leg, and an arcuate distal portion, the first leg and the second leg being parallel to each other; a cutting portion; The maximum cross-sectional area of the ultrasonic chip defines the cross-sectional area of a first slice, the cross-sectional area of a second slice is defined at a position 20 mm proximal to the distal end of the ultrasonic chip, the second slice and the first slice are each perpendicular to the longitudinal axis of the shaft, and the cross-sectional area of the second slice is 15-20% of the cross-sectional area of the first slice. Ultrasonic chip.

13. Each of the first leg and the second leg comprises a plurality of cutting teeth, less than half of the length of the cutting edge includes the plurality of cutting teeth, and each of the cutting teeth includes a tooth cutting edge and a notch base. The ultrasonic chip according to claim 12.

14. The cutting portion defines a center line along the longitudinal axis, a first distance is defined from the center line to the tooth cutting edge, a second distance is defined from the center line to the notch base, a third distance is defined from the center line to the starting point of the tapered portion, the difference between the first distance and the second distance is 0.25 mm or less, and the first distance is greater than 1.5 times but less than 2 times the third distance. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ smaller than The ultrasonic chip according to claim 12 or 13.

15. The ultrasonic chip according to claim 12 or 13, wherein the chip has a diameter of 9 mm or less.

16. The plurality of cutting teeth are disposed at a distal end of the cutting head, the arcuate distal portion is free of the plurality of cutting teeth, the plurality of cutting teeth include at least two adjacent cutting teeth and a notch therebetween, the notch has a lateral dimension, the lateral dimension of the notch is at least 1 / 25 of the lateral dimension of the base portion and The ultrasonic chip according to claim 12 or 13.

17. The ultrasonic chip according to claim 12 or 13, wherein the arcuate distal portion has a thickness of at least 1.35 millimeters.

18. The ultrasonic chip according to claim 12 or 13, wherein the shaft of the ultrasonic chip does not have a lumen at the distal end.

19. The ultrasonic chip defines a groove, and the ultrasonic chip includes a seal member disposed around the groove, a first hole defining an air inlet disposed proximal to the seal member, and a second hole extending from the proximal end of the ultrasonic chip to the first hole such that the second hole is in fluid communication with the first hole. The ultrasonic chip according to claim 12.

20. An ultrasonic instrument having a proximal region and a distal region, 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; wherein the transducer is configured to be coupled to a suction source by a first coupler. The ultrasonic instrument, an ultrasonic chip comprising a shaft and a cutting portion, removably coupled to the horn by a chip coupler, wherein the shaft has a longitudinal axis. a perfusion sleeve having a distal region and a proximal region and defining a lumen, the perfusion sleeve at least partially surrounding the shaft and defining an inlet opening configured to receive perfusion fluid from a perfusion source, the perfusion sleeve further comprising a first conduit in fluid communication with the lumen, the first conduit configured to carry perfusion fluid from the inlet opening to an outlet opening. a seal member disposed between an outer surface of the ultrasonic chip and an inner surface of the lumen. An ultrasonic surgical assembly for air-cooling the ultrasonic chip, comprising: The ultrasonic chip is: When the perfusion sleeve and the ultrasonic chip are coupled to the ultrasonic instrument, a first hole defining an air inlet disposed proximal to the seal member; A second hole extending from the proximal end of the ultrasonic chip to the first hole; Defining; The second hole communicates with the suction source via the chip coupler; When the perfusion sleeve and the ultrasonic chip are coupled to the ultrasonic instrument, the perfusion sleeve defines a third hole proximal to the first hole; The ultrasonic surgical assembly defines a path for drawing air from the ambient environment through the third hole and then through the first hole, and returning the air through the second hole before it exits the ultrasonic surgical assembly through the first coupler. Ultrasonic surgical assembly.

21. The ultrasonic surgical assembly according to claim 20, wherein the ultrasonic chip further defines a groove, and the seal member is disposed around the groove.

22. The ultrasonic surgical assembly according to claim 20 or 21, wherein the first hole is perpendicular to the axis of the second hole.

23. The ultrasonic chip further comprises: A base for coupling to the transducer and a body extending from the base, the body comprising the shaft and the cutting portion, the body being coupled to the base by the shaft, the body extending from the shaft to the cutting portion along the longitudinal axis, the cutting portion comprising a base portion and a tapered portion. The ultrasonic surgical assembly according to claim 20.

24. The ultrasonic chip further comprises: A first substantially planar side surface extending from the proximal end to the distal end; A second substantially planar side surface disposed on the opposite side of the first side surface and extending from the proximal end to the distal end. The ultrasonic surgical assembly according to claim 23.

25. The base portion has a transverse dimension between the first side surface and the second side surface, the transverse dimension extending perpendicular to the longitudinal axis; The tapered portion comprises a chamfered portion and extends from the base portion to a cutting edge, the cutting edge having a length and a U-shaped profile having a first leg, a second leg, and an arcuate distal portion, the first leg and the second leg being parallel to each other. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ and each having a plurality of cutting teeth, with less than half the length of the cutting edge being at the distal end having the plurality of cutting teeth and no such plurality of cutting teeth in the arcuate distal portion, The ultrasonic surgical assembly according to claim 24. **Claim 26** The ultrasonic surgical assembly according to any one of claims 20, 2 1, 23, 24 and 25, wherein the shaft of the ultrasonic tip has no lumen at the distal end. **Claim 27** Providing an ultrasonic tip comprising a shaft and a cutting portion, wherein the ultrasonic tip is removably coupled to a horn by a tip coupler, the horn is coupled to a transducer, the transducer is coupled to a suction source by a first coupler, the shaft has a longitudinal axis, and the ultrasonic tip defines a first hole defining an air inlet and a second hole extending from the proximal end of the ultrasonic tip to the first hole, the first hole being transverse to the second hole, and the second hole communicating with the suction source via the tip coupler; Providing an irrigation sleeve having a distal region and a proximal region and defining a lumen, the irrigation sleeve being configured to at least partially surround the shaft and being coupled to the irrigation source by an inlet opening configured to receive irrigation fluid from the irrigation source, the irrigation sleeve defining a first conduit in fluid communication with the lumen, the first conduit being configured to carry irrigation fluid from the inlet opening to an outlet opening; Providing a seal member between the outer surface of the ultrasonic tip and the inner surface of the lumen of the irrigation sleeve, the first hole being disposed proximal to the seal member; A method of cutting bone using the ultrasonic tip, the method comprising: Drawing air through the second hole and the first hole via the suction source to cool the ultrasonic tip. **Claim 28** The method according to claim 27, further comprising drawing in one of smoke and airborne particulate matter through the first hole and the second hole. **Claim 29** The method according to claim 27 or 28, further comprising sucking air through the first hole into the second hole to cool the ultrasonic tip. **Claim 30** ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The method according to claim 27, further comprising coupling the seal member to an outer surface of the ultrasonic chip. **Claim 31** Providing a third hole defined within the perfusion sleeve, the third hole being proximal to the first hole when the perfusion sleeve and the ultrasonic chip are coupled to the handpiece; and Suctioning air from the ambient environment through the third hole, passing the air through the first hole, and returning the air through the second hole. The method according to claim 27, further comprising the steps of: **Claim 32** An ultrasonic instrument, 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 instrument; An ultrasonic chip having a shaft and a cutting portion, removably coupled to the horn; A perfusion sleeve defining a lumen, the perfusion sleeve having a body releasably coupled to the distal portion of the housing and having a distal region and a proximal region; The ultrasonic chip further comprises: An annular seal member; The ultrasonic chip defining a groove; The annular seal member is disposed around the groove and in the proximal region of the body, and is positioned between an outer surface of the ultrasonic chip and an inner surface of the lumen when the sleeve and the ultrasonic chip are coupled to the ultrasonic instrument. The annular seal member is configured to prevent fluid movement proximal to the annular seal member. An ultrasonic surgical assembly. **Claim 33** An ultrasonic instrument, 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 instrument; A perfusion sleeve defining a lumen, the perfusion sleeve configured to be removably coupled to a first ultrasonic chip and a second ultrasonic chip, each of the first ultrasonic chip and the second ultrasonic chip configured to be removably coupled to the horn by a chip coupler, each of the first ultrasonic chip and the second ultrasonic chip comprising: A shaft; A cutting portion, the cutting portion of the first ultrasonic chip having a cutting shape different from the cutting shape of the cutting portion of the second ultrasonic chip; An annular seal member; ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ comprising, the first ultrasonic chip defining a first groove positioned at a first distance from the chip coupler of the first ultrasonic chip, the second ultrasonic chip defining a second groove positioned at a second distance from the chip coupler of the second ultrasonic chip, the first distance from the chip coupler of the first ultrasonic chip being unequal to the second distance from the chip coupler of the second ultrasonic chip, and each of the first and second ultrasonic chips including an annular seal member disposed around each of the first and second grooves, the perfusion sleeve comprising a body releasably coupled to the distal portion of the housing, and a perfusion conduit coupled to the body and configured to carry a perfusion fluid, comprising, the perfusion conduit further defining an inlet opening disposed in a proximal region of the body and an outlet opening disposed in a distal region of the body, the perfusion fluid entering the perfusion conduit at the inlet opening and exiting the perfusion conduit at the outlet opening, a perfusion sleeve, an ultrasonic surgical assembly comprising. ​ ​ ​ ​ ​ ​ ​ ​ ​

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