Flow channel for ultrasonic attraction surgical amplitude transformer

Abstract

A flow channel for use with an ultrasonic surgical tip, the flow channel having a base and one or more overmolded portions. The flow channel base may include connectors on opposite ends of the base body. One or more overmolded portions may be positioned on opposite ends of the runner. The tip may include one or more third horn members of half wavelength.

Description

Background Art

[0001] The present invention relates generally to ultrasonic surgical devices and, more particularly, to ultrasonic surgical aspirators for removing diseased tissue.

[0002] Devices that effectively utilize ultrasonic energy for various applications are well known in many different fields. One of these devices is an ultrasonic horn or tip for removing tissue. As early as 1962, the ampulla profile or Gaussian profile was published by Kleesattel and used as the basis for many ultrasonic horns in surgical applications, including the device for ultrasonic aspiration described in U.S. Patent No. 4,063,557 issued to Wuchinich et al. in 1977 and U.S. Patent No. 6,214,017 issued to Stoddard et al. in 2001, which are incorporated herein by reference. The Gaussian profile is used in practice to establish and control the resonance and mechanical gain of the horn. The resonator, the connecting body and the horn together act as a three-body system to provide a mechanical gain, which is defined as the ratio of the output stroke amplitude at the distal end of the tip to the input amplitude of the resonator. The mechanical gain is the result of the strain induced in the materials constituting the resonator, the connecting body and the ultrasonic horn.

[0003] A magnetostrictive or piezoelectric transducer coupled to a connecting body is used as the first stage of the intensifier horn, having a mechanical gain of about 2:1, due to the reduced area ratio of the walls of the complex geometry. The major diameter of the horn transitions in a stepped horn geometry to the large diameter of the Gaussian section having a gain of about 5:1, also due to the reduced area ratio. The uniform strain along the length of the Gaussian section provides a multiplicative gain of typically less than 2:1. Thus, the application of ultrasonic vibrating surgical devices for fragmenting and removing unwanted tissue in a very precise and safe manner has led to the development of many valuable surgical procedures.

[0004] Some devices known in the art characteristically produce continuous vibrations having a substantially constant amplitude at a frequency of about 20 kHz to about 55 kHz (e.g., at a predetermined frequency of 20-36 kHz). Because the maximum stress in the horn material is proportional to the amplitude multiplied by the frequency, the amplitude of the transducer-surgical tip system decreases with increasing frequency, and the material must be maintained at an allowable portion of its yield strength in order to support the rated life in view of the fatigue limit of the material. For example, devices suitable for removing soft tissue disclosed in U.S. Patent Nos. 4,063,557, 4,223,676, and 4,425,115, which are incorporated herein by reference, are particularly suitable for removing highly compliant elastic tissue mixed with blood. Such devices are suitable for continuous operation when the surgeon wishes to fragment and remove tissue, and are typically operated by a foot switch.

[0005] Ultrasonic suction has become the standard of care for removing tumors and diseased tissues in neurosurgery and general surgery. Typically, an ultrasonic surgical suction device for breaking and attracting tissue includes an ultrasonic transducer supported in a handpiece, an ultrasonic vibrating horn or tip operably connected to the ultrasonic transducer, and a sleeve or flow channel positioned around the horn. The horn includes a longitudinally extending central hole having an end located adjacent to the distal tip and a second end adjacent to the proximal end of the horn. The proximal end of the horn is adapted to engage a vacuum source to facilitate the attraction of fluid. The flow channel is positioned around the horn to define an annular channel. Irrigation fluid is supplied to the surgical site through the annular channel around the horn, where the irrigating fluid is mixed with blood and tissue particles and is attracted through the holes in the horn. By mixing the irrigating fluid with the blood and tissue particles, the coagulation of blood is slowed down and attraction is facilitated. U.S. Patents Nos. 5,015,227 and 4,988,334 disclose such ultrasonic surgical devices and are incorporated herein by reference. For example, a titanium surgical tip can be powered by a transducer to disrupt tissue and aspirate effluent through a central channel. The channel is used to deliver an irrigation fluid (usually saline), and it protects tissue along the path from the vibrating surgical tip to the surgical site. The transducer vibrates along its length, and the ultrasonic horn (such as a stepped horn and a special profile with reduced diameter) amplifies the vibration.

[0006] Known instruments on the market for ultrasonically disrupting tissue at a surgical site and attracting tissue particles and fluid away from the site are Excel Ultrasonic Surgical Aspirator (Integra Life Sciences Corporation, Plainsboro, NJ). When the longitudinally vibrating tip in this aspirator is brought into contact with tissue, it gently, selectively, and precisely fragments and removes tissue. The amplitude of the CUSA transducer can be adjusted independently of the frequency, which can be maintained constant under load depending on the reserve power of the transducer. In a simple harmonic motion device, the frequency is independent of the amplitude. The advantages of this unique surgical instrument include: minimal damage to healthy tissue during tumor removal, skeletonization of blood vessels, rapid healing of tissue, minimal heating or shearing of surrounding tissue edges, minimal pulling on healthy tissue, and excellent tactile feedback for selectively controlled tissue fragmentation and removal.

[0007] In devices that fragment tissue by ultrasonic vibration of the tool tip, the efficiency of energy utilization is optimized when the transducer providing the ultrasonic vibration is operated at a resonant frequency. The design of the transducer and surgical tip establishes the resonant frequency of the system, while the generator tracks the resonant frequency and generates an electrical drive signal to vibrate the transducer at the resonant frequency. However, changes in operating parameters (such as temperature, thermal expansion, and changes in load impedance) result in deviations from the resonant frequency. Therefore, a controlled change in the drive signal frequency is required to track the resonant frequency. This is automatically controlled in the generator.

[0008] Common ultrasonic surgical suction tips used in surgical operations for many years generally present an annular surface of longitudinal vibration, which has a central channel providing suction or attraction, which contacts tissue and breaks it via the mechanism of mechanical impact (momentum), cavitation and ultrasonic propagation described. Mechanical impact may be most useful in soft tissues, and in the presence of liquid and high-intensity ultrasound exceeding the cavitation threshold, cavitation significantly helps to break stubborn and hard tissues. When performing tissue ablation surgery, ultrasonic surgical suction devices can be inserted into the patient's body through a trocar. Once inserted, the surgeon can use the activated ultrasonic tip at the surgical site to break and attract tissue. In laparoscopic surgical applications, the flow channel can deliver flushing to the surgical site. The flow channel can serve as a protective barrier between the operating ultrasonic tip and the trocar and / or the human body.

[0009] Ultrasonic propagation involves the transfer of pressure across the boundary of the surgical tip and tissue, which results in the transmission of pressure and, perhaps more importantly, particle displacement. Acoustic impedance is the overall response of a medium to the transmission of sound through it, expressed by the complex ratio of pressure to effective flux (i.e., particle velocity multiplied by the surface area through the medium). As discussed in the classic text ULTRASONIC TESTING OF MATERIALS by Krautkramer J. and Krautkramer H. (Berlin, Heidelberg, New York, 1983), for the case of low to high acoustic impedance boundaries, the transmitted pressure may exceed 100%, which seems paradoxical, but is a result of the pressure accumulation from the low to high acoustic impedance boundary. In the case of high to low acoustic impedance mismatch, such as the case of using a high impedance titanium ultrasonic horn to low impedance fibrous muscle, soft tissue or water, the transmitted pressure is reduced (e.g., less than 15% of titanium to fibrous muscle) and the particle displacement is increased (e.g., up to 186% of titanium to muscle).

[0010] Typical all-silicone flow channels may deflect longitudinally during movement through the trocar and visually obscure the working surface of the ultrasonic tip. Silicone rubber has a high coefficient of friction, low durometer, and drags in the trocar, resulting in considerable total deflection when this friction is applied to a long length of silicone.

[0011] Thus, those skilled in the art have recognized a need to reduce friction, increase stiffness, reduce trocar-induced stretching, and / or maintain distal end visibility throughout a surgical procedure. The present invention satisfies this need and others. Summary of the invention

[0012] In some embodiments of the present invention, for example, a flow channel for use with an ultrasonic horn may include a base having a first connector and a second connector interconnected by a base body. In various embodiments, the base body may include a first end and an opposite second end. In some embodiments, the first end of the base body may include a first connector, and the second end of the base body may include a second connector. In some embodiments, the first connector may include a first overmolded portion adapted to engage a front cone. In various embodiments, the second connector may include a second overmolded portion.

[0013] In addition, in some embodiments, at least one of the first connector and the second connector can be fixed to the base body by at least one of plastic welding, adhesive bonding, and adhesive sealing. In various embodiments, at least one of the first connector and the second connector can be fixed to the base body by plastic welding and adhesive bonding. In some embodiments, at least one of the first connector and the second connector can be fixed to the base body by adhesive sealing. In various embodiments, at least one of the first connector and the second connector may include one or more ribs, wherein the one or more ribs are respectively overmolded by the first overmolded portion and the second overmolded portion. In some embodiments, at least one of the first connector and the first overmolded portion can define at least a portion of the flushing port. In various embodiments, the second overmolded portion may include a through opening that tapers away from the second connector.

[0014] In some embodiments, an ultrasonic surgical device for fragmenting tissue and removing fragmented tissue may include a surgical handpiece comprising a housing, a nose cone attached to the housing, a flow channel attached to the nose cone, and / or a transducer mounted within the housing. In various embodiments, the device may include a surgical tip connected to the transducer via an internal horn. In some embodiments, the device may include an irrigation system connected to the handpiece for supplying irrigation fluid adjacent to a surgical site to suspend fragmented tissue. In various embodiments, the device may include a suction system connected to the handpiece for attracting fluid and fragmented tissue at the surgical site. In some embodiments, the flow channel may have a first end and an opposite second end. In various embodiments, the flow channel may include a base, a first overmolded portion defining the first end, and / or a second overmolded portion defining the second end.

[0015] In addition, in some embodiments, the base may include a base body having a first end and an opposite second end, a first connector, and / or a second connector. In various embodiments, the first connector may be connected to the first end of the base body, and the second connector may be connected to the second end of the base body. In some embodiments, the first connector may include a first overmolded portion, and the second connector may include a second overmolded portion. In various embodiments, at least one of the first connector and the second connector may include one or more ribs that engage the first overmolded portion and the second overmolded portion, respectively. In some embodiments, at least one of the first connector and the second connector may be fixed to the first end and the second end of the base body, respectively, by at least one of plastic welding, adhesive bonding, and / or adhesive sealing. In various embodiments, at least one of the first connector and the second connector may be fixed to the first end and the second end of the base body, respectively, by plastic welding and adhesive bonding. In some embodiments, at least one of the first connector and the second connector may be fixed to the first end and the second end of the base body, respectively, by adhesive sealing. In various embodiments, the first connector and the second connector may be made of a material different from the first overmolded portion and the second overmolded portion. In some embodiments, the base body can be made of a material different from the first overmolded portion and the second overmolded portion. In some embodiments, the proximal seal may be eliminated and a fully sealed rigid (e.g., polycarbonate, etc.) section is included. In general, the embodiments constitute a composite flow channel or a hybrid flow channel (an overmolded proximal sealing material such as silicone to a rigid portion such as polycarbonate to a distal overmolded sealed and arc-resistant material such as silicone) that supports the propagation and transmission of ultrasonic energy and radio frequency (RF) energy required to fragment and coagulate tissue during surgery. The combination of the hybrid flow channel and the extendable surgical tip supports the longest ultrasonic aspirator instrument in the art.

[0016] In some embodiments, a method for attaching a component of an ultrasonic surgical device may include providing a nose cone. In various embodiments, the method may include providing a first flow channel having a first length. In some embodiments, the first flow channel may include one or more overmolded portions on a first connector and a second connector, wherein the first connector and the second connector are attached to each end of a first base body. In some embodiments, the method may include providing a handpiece having a body. In various embodiments, the method may include providing a tip. In some embodiments, the method may include connecting the nose cone to the handpiece.

[0017] Additionally, in various embodiments, the method may include providing a second flow channel having a second length different from the first length, wherein the second flow channel includes one or more overmolded portions on the first connector and the second connector, and wherein the first connector and the second connector are attached to each end of the second base body. In some embodiments, the method may include connecting at least one of the first flow channel and the second flow channel to the nose cone. In various embodiments, the method may include connecting the first flow channel to the nose cone.

[0018] In some embodiments, a method for attaching a member of a flow channel may include overmolding a first overmolded portion onto a first connector. In various embodiments, the method may include overmolding a second overmolded portion onto a second connector. In some embodiments, the method may include providing a base body having a first end and a second end. In various embodiments, the method may include connecting the first connector and the first overmolded portion to the first end of the base body. In some embodiments, the method may include connecting the second connector and the second overmolded portion to the second end of the base body.

[0019] In addition, in various embodiments, the method may include connecting the first connector and the second connector to the base body by at least one of plastic welding, adhesive bonding and / or adhesive sealing. In some embodiments, the method may include connecting the first connector and the second connector to the base body by plastic welding and adhesive bonding. In various embodiments, the step of overmolding the first overmolded portion and the second overmolded portion on the first connector and the second connector, respectively, may occur before the step of connecting the first connector and the second connector to the base body. In some embodiments, the first overmolded portion and the second overmolded portion are overmolded on one or more ribs protruding outwardly from the periphery of the first connector and the second connector, respectively. In various embodiments, each of the first connector and the first overmolded portion may define at least a portion of the flushing port. In some embodiments, the method may include changing the length of the base body from the first end to the second end to change the length of the flow channel.

[0020] In some embodiments, an ultrasonic horn may include a first horn component, a second horn component, and / or one or more third horn components connecting the first horn component to the second horn component within a predetermined overall length of the horn.

[0021] Additionally, in some embodiments, at least one of the third horn members can be a half wavelength of approximately 107 mm. In various embodiments, the third horn member can be positioned at an anti-node. In some embodiments, the method can include a threaded coupling between the third horn member and each of the first horn member and the second horn member.

[0022] In some embodiments, a method for changing the length of an ultrasonic horn may include the step of providing a first horn member. In various embodiments, the method may include providing a second horn member. In some embodiments, the method may include determining the total length of the ultrasonic horn. In some embodiments, the method may include selecting one or more third horn members to achieve the total length of the ultrasonic horn. In various embodiments, the method may include connecting one or more third horn members between the first horn member and the second horn member. Such a flow channel and an extendable surgical tip can produce the longest ultrasonic aspirator surgical instrument in the art.

[0023] Additionally, in some embodiments, the coupling may be a threaded joint. In various embodiments, the method may include pneumatically tightening one or more third horn members with dedicated equipment. In various embodiments, the method may include over-torquing the coupling. In some embodiments, the coupling may be adjacent to an anti-node.

[0024] Other features and advantages of the present invention will become more apparent from the following detailed description of the invention taken in conjunction with the attached exemplary drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In the drawings, like reference numerals generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.

[0026] The present invention is described herein with reference to the accompanying drawings, in which:

[0027] Figure 1 is a perspective view of an ultrasound device according to the present invention;

[0028] Figure 2 More detailed examples Figure 1 The proximal end of the device;

[0029] Figure 3 is a perspective view of the nose cone fully assembled to the handpiece / nose cone and supporting the flow channel (the flow channel tube is not shown in this figure);

[0030] Figure 4A is a perspective view of one embodiment of an ultrasonic horn;

[0031] Figure 4B yes Figure 4A An exploded view of an ultrasonic horn;

[0032] Figure 4C yes Figure 4A A side cross-sectional view of an ultrasonic horn;

[0033] Figure 4D is a perspective view of another embodiment of an ultrasonic horn, in which an example is shown Figure 4A The third horn member increases the length of the horn compared to the horn shown;

[0034] Figure 4E yes Figure 4D An exploded view of an ultrasonic horn;

[0035] Figure 4F yes Figure 4D A side cross-sectional view of an ultrasonic horn;

[0036] FIG. 4G is a perspective view of another embodiment of an ultrasonic horn, illustrating Figure 4D Compared to the horn shown, the two third horn members increase the length of the horn;

[0037] Figure 4H is an exploded view of the ultrasonic horn of FIG. 4G ;

[0038] Fig. 4I is a side cross-sectional view of the ultrasonic horn of FIG. 4G ;

[0039] Figure 5 is a cross-sectional view of an embodiment of a flow channel according to the present invention (the flow channel tube is not shown in this figure);

[0040] Fig. 6A A perspective view showing an embodiment of a first connector;

[0041] Figure 6B Shows Fig. 6A Another perspective view of the first connecting member;

[0042] Figure 6C A perspective view showing an embodiment of a second connector;

[0043] Fig.6D Shows Figure 6C Another perspective view of the second connecting member;

[0044] Fig. 7A An embodiment of the first overmolded portion is shown in combination with Fig. 6A a perspective view of a first connecting member;

[0045] Figure 7BAn embodiment of the second overmolded part is shown in combination with Figure 6C a perspective view of a second connecting member;

[0046] FIG. 8A to FIG. 8F Illustrated Fig. 6A a plurality of views of a first connector;

[0047] 9A to 9F Illustrated Figure 6C a plurality of views of a second connector;

[0048] Fig.10 is an enlarged cross-sectional view of one embodiment of a connection between a second connector and a base body;

[0049] Fig.11 is an enlarged cross-sectional view of one embodiment of a connection between a first connector and a base body. DETAILED DESCRIPTION

[0050] Embodiments of the ultrasonic horn disclosed in the present invention will now be described in detail with reference to the accompanying drawings, wherein the same reference numerals represent the same or corresponding elements in each of the several views. As used herein, the term "distal end" refers to the portion of the instrument or its component that is farther from the user in normal use, and the term "proximal end" refers to the portion of the instrument or its component that is closer to the user. The terms "ultrasonic horn", "ultrasonic tip", "ultrasonic suction tip", "ultrasonic surgical suction tip", "suction tip", "ultrasonic surgical tip", "surgical tip" and "tip" are used interchangeably herein. The types of energy that can be used are mainly discussed with "ultrasound", but radio frequency (RF) energy may also be included. The terms "flow channel", "irrigation flow channel", "sleeve", "irrigation manifold" and "manifold" are used interchangeably herein. The terms "tip extender" and "horn extender" are used interchangeably herein.

[0051] Reference now Figures 1 to 3 , shows an embodiment of a device for ultrasonically fragmenting and aspirating tissue of the present disclosure. The present disclosure relates to an ultrasonic surgical device 10 for ultrasonically fragmenting and aspirating tissue during surgery. Typically, an ultrasonic surgical device includes a handpiece 12 used by a surgeon to guide the fragmentation. The handpiece 12 covers a transducer (not shown), and a surgical tip or ultrasonic horn 14 is fastened to the transducer. The ultrasonic horn can be powered by the transducer and ultrasonically actuated to fragment tissue and aspirate effluent through a central channel. The distal end 13 of the ultrasonic horn 14, or a portion thereof, extends beyond the distal end of the flow channel 20. The ultrasonic horn 14 vibrates during surgery to fragment tissue. The ultrasonic horn can be made of titanium or other common materials known in the art.

[0052] A cooling and flushing system is provided to provide cooling fluid to the ultrasonic horn 14 for maintaining the temperature within an acceptable range. The handpiece 12 includes a housing 15, which can be formed of sterilizable plastic or metal, but is preferably plastic. The flow channel 20 provides a path for the flushing fluid or liquid and is connected to the distal end of the housing 15. The flow channel 20 is usually docked with the handpiece 12 via a front cone 32. The flow channel 20 may include or be attached to the flow channel tube 16 and is in fluid communication with the flow channel tube 16 through an opening 21. The front cone 32 is attached to the handpiece 12 and covers the inner portion of the ultrasonic horn 14.

[0053] During surgery, an irrigation tube 22 is connected upstream of the flow tube 16 and supplies irrigation fluid to the operating site through the flow tube 16. A suction tube 24 provides a suction path from the operating site to a collection tank (not shown). Alternatively, the suction tube can be mounted on the outside of the housing 15. A flow tube clamp 19 allows the position of the flow tube 16 to be adjusted according to the surgeon's preference during surgery. A cable 26 for providing power to the device or providing a switch connection is also shown.

[0054] FIG. 4A to FIG. 4C An embodiment of an ultrasonic horn 14 is illustrated, which is suitable for the ultrasonic surgical device used to crush and attract tissues as described above. The ultrasonic horn has an outer surface 120 and includes a first horn or proximal member 14a and a second horn or distal member 14b extending distally from the first horn or proximal member. Although the first horn member 14a is connected / connected to the second horn member 14b by a threaded coupling 18 (e.g., a male and female coupling), it should be understood that various couplings / couplings or methods of combining two or more horn members (e.g., a first horn member 14a, a second horn member 14b, a third horn member 14c, etc.) can be used. For example, the threaded coupling 18 (if used) can be over-torqued and / or laser welded. In some embodiments, one or more couplings of the horn member can be a press-fit portion. The press-fit portion (if used) can be laser welded and / or an electron beam welded connection portion. Another example of a press-fit portion can be fixed with a pin. In one embodiment shown, the first horn member 14a may include female or tapped threads on a distal end, while the second horn member 14b includes male threads on a proximal end to define the threaded coupling 18. FIG. 4D to FIG. 4IAs shown, the ultrasonic horn 14 can have one or more additional horns, modules or components 14c (e.g., a third horn component 14c) to change the length of the horn (e.g., the overall length) for one or more applications. In one embodiment shown, the third horn component 14c can include a female thread or tapping thread on the distal end and a male thread on the proximal end to define a threaded coupling 18 or a portion thereof. The ultrasonic horn 14 has a distal portion 13 and a threaded proximal end 111, a through hole 117, a pre-attraction hole or a transverse hole 115, and a hexagonal engagement portion 119. The ultrasonic horn has a larger outer diameter in the first horn or proximal component 14a section and a smaller outer diameter in the second horn or distal component 14b section.

[0055] Although the ultrasonic horn shown is not stepped, it is known that there are stepped ultrasonic horns. In some embodiments not shown, the ultrasonic horn may have a single long horn body, rather than two or more horns / members of two or more different diameters. A single long horn extender may have a constant outer diameter over its entire length or have a gradually changing diameter along its length, for example, having a diameter that gradually decreases toward the distal end along its length. In addition, one or more horns / members may form a step, or may form a smooth transition from another horn / member without forming any obvious steps. The ultrasonic horn may vibrate within an ultrasonic frequency range with a longitudinal amplitude exceeding approximately 5 mils (0.005 inches) to 14 mils (0.014 inches).

[0056] The through hole 117 may also have a section of larger diameter within the first horn 14a and a section of smaller diameter within the second horn 14b. As can be readily determined by one skilled in the art, the diameters of the through holes, such as the proximal larger diameter of the first horn, the distal smaller diameter portion of the second horn, or the diameter of one or more third members (if used), may have any suitable diameter. For example, the diameter of the distal smaller diameter through hole portion may be about 0.078 inches. The through hole does not necessarily have to correspond to the geometry of one or more members / horns. The through hole may have two or more diameters in a stepped or other form, have a constant diameter throughout its length, or have a diameter that gradually changes (e.g., gradually decreases) along its length toward the distal end.

[0057] The ultrasonic horn 14 is substantially circular in cross section and is disposed within the flow channel 20. During operation of the ultrasonic device 10, an irrigation fluid is supplied into the flow channel 20 through the opening 21. An annular cavity 36 is defined between the flow channel 20 and the ultrasonic horn 14. The irrigation fluid is supplied from the flow channel 20 to the distal end of the ultrasonic horn 14 through the cavity 36. A transverse hole is formed in the pre-suction hole 115 near the distal end of the ultrasonic horn 14 and communicates with the through hole 117. The irrigation fluid is sucked from the pre-suction hole 115 and the surgical site together with the broken tissue, blood, etc. into the inlet 31 of the through hole 117, and is removed from the surgical site via the through hole 117 and the suction tube 24. When the inlet 31 is blocked or occluded by the tissue to be removed, the transverse hole provides another way for the fluid to enter the through hole 117. The pre-suction hole 115 ensures that a large amount of irrigation agent is available in the continuous cooling circuit. The irrigation agent also helps to prevent or reduce the immediate coagulation of blood that may block the channel.

[0058] In more detail, an irrigation liquid (e.g., saline) is required to cool the surgical tip and tissue disruption site. This irrigation liquid is supplied to the flow channel with a peristaltic pump at a rate as low as 2 to 3 ml / min, which is typically only one or two drops per second. The irrigation liquid is supplied at the proximal end of the ultrasonic horn. The irrigation liquid advances to near the distal end of the ultrasonic horn, where two 0.015-inch diameter pre-aspiration holes draw most (perhaps 90-95%) of the irrigation agent through holes that connect the outer horn diameter to the central aspiration channel. This irrigation and aspiration action provides a continuous cooling circuit for the vibrating titanium and also helps to moisten the effluent (such as blood and tissue) in the central channel. Some irrigation also helps to cool the surgical site, improve coupling to tissue, and provide cavitation necessary to emulsify and aspirate tissue (such as tumors).

[0059] In some embodiments, two or more components and / or injections of material may be overmolded together to create a flow channel. Figure 1 The ultrasonic surgical device 10 of exemplifies an overmolded flow channel 20 extending from a nose cone 32 or portion of the device toward one end 13 of the surgical tip 14. Figures 1 to 3 as well as Figure 5 to Figure 1 2E, the flow channel 20 may include at least one overmolded material injection piece (e.g., the same or different material injection piece) to manufacture the flow channel. The flow channel 20 may include a base 50 or a portion thereof (e.g., a base body 55, a connector 70) and one or more overmolded portions 40, 60. The flow channel 20 and / or body 22 may include opposite ends, namely, one end 20a adjacent to the nose cone 32 and another end or free end 20b adjacent to the free end 13 of the surgical tip 14 (e.g., a bone tip). Figure 5 , Fig.10 and Fig.11 In one embodiment shown, the overmolded portion 40, 60 can be adjacent to each end 20a, 20b of the flow channel 20, the connector 70 (e.g., connectors 72, 74), and / or the base 50 (e.g., bases 50a, 50b). The overmolded portion can include a first overmolded portion 40 and a second overmolded portion 60. The first overmolded portion or flow channel boot 40 can be adjacent to the first end 50a of the base 50 and / or the first end 20a of the flow channel / body 22. The first overmolded portion 40 (e.g., the second end 40b) can be overmolded onto the base 50 or a portion thereof (e.g., connectors 70, 72). The second overmolded portion or flow channel tip 60 can be adjacent to the second end 50b of the base 50 and / or the second end 20b of the flow channel / body 22. The second overmolded portion 60 (e.g., first end 60a) can be overmolded onto the base 50 or a portion thereof (e.g., connectors 70, 74). The first overmolded portion 40 of the flow channel 20 can include a molded flushing port 42 and / or a portion of the flow channel opening 21, etc. The second overmolded portion 60 (e.g., second end 60b) of the flow channel 20 can taper from the base 50 (e.g., base body 55, second connector 74) in a direction toward the open free end 20b of the flow channel, thereby surrounding or adjacent to the surgical tip 13. In some embodiments, the base 50 or a portion thereof can taper toward the overmolded portion 60 or flow channel free end 20b of the flow channel 20. In various embodiments, the base 50 (e.g., base body 55) can have a constant diameter (e.g., inner circumference and / or outer circumference). The inner circumference 55c can define a through opening 56. In some embodiments, the first overmold portion 40 and the second overmold portion 60 can be made of one or more materials (e.g., silicone, polycarbonate, acetal, nylon, Etc.). The first overmolded portion or runner cover 40 can be made of a first material. The second overmolded portion or runner tip 60 can be made of a second material. The first material and the second material can be the same or different. In some embodiments, the first material of the first overmolded portion and the second material of the second overmolded portion can be made of the same or different materials. For example, both the first material and the second material can be made of silicone. Further, the first overmolded portion and the second overmolded portion can be made over the base 50 or a portion thereof (e.g., the base body 55 and / or the connector 70) in a single overmolding injection. Alternatively, the first overmolded portion 40 and the second overmolded portion 60 can be made or overmolded together with (e.g., the base body 55 and / or the connector 70) in two or more different injections. As shown in one embodiment, the first and second overmolded portions 40, 60 can be made or overmolded (e.g., silicone over polycarbonate) over their respective connectors 70 (e.g., first connector 72, second connector 74) in one or more material injections.

[0060] In some embodiments, the flow channel 20, base 50, base body 55, and / or device 10 may include one or more connectors 70 that interconnect the first overmolded portion 40 and / or the second overmolded portion 60 to the base body 55. Figures 5 to 11 In one embodiment shown, the base 50 may include a base body 55, a first / proximal connector / coupling 72, and / or a second / distal connector / coupling 74. The base 50 and / or the base body 55 may be made of polycarbonate, acetal, nylon, and / or any other extrudable or fiber-filled polymer, but is not limited thereto. Such rigid sections can be extruded in known processes and can be extended as needed for surgical tips of different lengths. In some embodiments, base 50 and / or base body 55 can be an extruded tube. Connectors 70 (e.g., connectors 72 and / or 74) can be made of polycarbonate, acetal, nylon, And / or any other extrudable or fiber-filled polymer, but not limited thereto. The base body 55 and / or the connector 70 may have a certain hardness that can eliminate or reduce the longitudinal deflection of the device 10 / flow channel 20 or a portion thereof (e.g., during movement through the trocar). In some embodiments, the base body 55 and / or the connector 70 may have a stiffness ranging from about 100,000 psi to about 350,000 psi. The base body 55 may include a first end 55a adjacent to the first end 20a of the flow channel 20 and a second end 55b adjacent to the second end 20b of the flow channel 20. The first connector 72 (if used) may be adjacent to the first end 55a of the base body 55. The second connector 74 (if used) may be adjacent to the second end 55b of the base body 55. The first overmolded portion 40 (if used) may be overmolded onto the first connector 72. The second overmolded portion 60 (if used) may be overmolded onto the second connector 74. For example, the silicone of the first overmolded portion 40 and / or the second overmolded portion 60 can be molded over the polycarbonate of the first polycarbonate connector 72 and the second polycarbonate connector 74, respectively. One or more combined connectors 70 and overmolded portions 40, 60 can then be combined / secured / secured to the opposite ends 55a, 55b of the base body 55, respectively. Although not shown, the connector 70 can be attached to the base body 55 and then overmolded with one or more overmolded portions 40, 60 (e.g., the first overmolded portion, the second overmolded portion, etc.). In some embodiments, the first overmolded portion 40 and the first connector 72 and / or the second overmolded portion 60 and the second connector 74 can be plastic / laser welded, adhesively bonded and / or sealed (e.g., by an adhesive) to the base body 55 (e.g., the first end 55a, the second end 55b). An example of an adhesive for sealing / bonding the attachment between the parts of the base may be a LOCTITE brand adhesive, but is not limited thereto. One or more connectors 70 may be welded to one or more ends 55a, 55b of the base body 55 only by plastic / laser welding. One or more connectors 70 may be bonded to one or more ends 55a, 55b of the base body 55 only by adhesive. One or more connectors 70 may be bonded to one or more ends of the base body by plastic / laser welding and by adhesive. Welding and / or adhesive bonding may be performed circumferentially around the entire periphery / inner circumference (e.g., 360 degrees), as shown in one embodiment or a portion thereof. Further, adhesive sealing (if used) may be performed after plastic / laser welding and / or adhesive bonding. Using adhesive sealants at the seams of plastic welding and / or adhesive bonding may be used as a secondary measure to seal discontinuities (if any) during the laser / welding process, thereby enhancing the dielectric resistance of the joint to ensure safety of electrosurgery.In some embodiments, an adhesive sealant may be applied to portions of the overmolded portion. Fig.10 and Fig.11 As shown in one embodiment, a plastic / laser welding area / portion 27, an adhesive bonding area / portion 28 and / or a sealing area / portion 29 (e.g., via an adhesive) is used to connect one or more portions of the base body 55 and one or more portions of the connector / overmolded portion.

[0061] In some embodiments, the base 50, flow channel 20, base body 55 and / or device 10 may include at least a first connector 72. Figure 5 , Fig. 6A , Figure 6B , Fig. 7A as well as FIG. 8A to FIG. 8FAs shown, the first connector 72 may include a first end 72a adjacent to the first overmolded portion 40 (e.g., the second end 40b) and an opposite second end 72b adjacent to the base body 55 (e.g., the first end 55a). The first connector 72 may include an inner periphery 73a defining a through opening 72c. The first connector 72 may include an outer periphery 73b. The outer periphery 73b may include a diameter reduction or step from the first end 72a toward the second end 72b. The door 73d (if used) may be positioned on the outer periphery 73b (e.g., adjacent to one or more ribs 73e). The first connector 72 may include / define a molded flushing port 42 and / or a portion of the opening 21, etc. As shown in one embodiment, the port 42 may be positioned to pass through the outer periphery 73b (e.g., a larger diameter step) from the inner periphery 73a and protrude outwardly from it. The first connector 72 may include one or more annular ribs 73e protruding outwardly from the outer periphery 73b (e.g., a larger diameter step). As shown in one embodiment, rib 73e can be continuous around the periphery. However, in some embodiments, ribs may not extend 360 degrees around the periphery. Ribs 73e can be spaced apart from each other in the longitudinal direction. The periphery 73b (e.g., one or more annular ribs, ports) of the first end 72a of the first connector 72 can be overmolded by a portion of the first overmolded portion 40. The first overmolded portion 40 can protrude longitudinally from the first end 72a toward the front cone 32 and / or protrude radially outward from the periphery 73b. The first overmolded portion 40 can cover the end face or radial step 73f of the face facing the base body 55 between the larger diameter and smaller diameter peripheral portions. There can be extruded ribs 73g (if used), which surround the periphery 73b of the smaller diameter periphery, spaced apart from the step 73f of the longitudinal range of the adjacent first overmolded portion. The first connector 72 (e.g., the second end 72b or the smaller diameter outer periphery) can be inserted into the first end 55a of the base body 55 and fixed (e.g., by welding, adhesive bonding and / or adhesive sealing, etc.). The first end 72a and the inner step extending radially outward from the outer periphery of the first connector can define an end face 73h. One or more portions of the end face 73h can be engaged / sealed against the front cone 32. The first overmolded portion 40 or a portion thereof (e.g., the inner periphery, the longitudinal end face facing the front cone, etc.) can be sealed against one or more surfaces of the front cone 32.

[0062] In some embodiments, the base 50, flow channel 20, base body 55 and / or device 10 may include at least one second connector 74. Figure 5 , Figure 6C , Fig.6D , Figure 7B as well as 9A to 9FAs shown, the second connector 74 may include a first end 74a adjacent to the base body 55 (e.g., the second end 55b) and an opposite second end 74b adjacent to the second overmolded portion 60 (e.g., the first end 60a). The second connector 74 may include an inner periphery 75a defining a through opening 74c. The through opening 74c tapers from the first end 74a to the second end 74b. The second connector 74 may include an outer periphery 75b. The diameter of each end 74a, 74b of the second connector 74 may decrease away from the center or collar 74d. The door 75d (if used) may be positioned on the outer periphery 75b (e.g., adjacent to one or more ribs 75e). The second connector 74 may include one or more annular ribs 75e protruding outward from the outer periphery 75b (e.g., the second end 74b). As shown in one embodiment, the rib 75e may be continuous around the periphery. However, in some embodiments, the rib may not extend 360 degrees around the periphery. The ribs 75e may be spaced apart from each other in the longitudinal direction. The outer periphery 75b (e.g., one or more annular ribs) of the second end 74b of the second connector 74 can be overmolded by a portion of the second overmolded portion 60. The second overmolded portion 60 can cover the end face 75f extending toward the second overmolded portion 60 adjacent to the second end 74b and / or the end face or radial step 75g of the second overmolded portion 60 facing the adjacent larger diameter collar. There can be an extrusion rib 75h (if used) that surrounds the outer periphery 75b of the collar adjacent to the step 75g, adjacent to the longitudinal extent of the second overmolded portion. The second overmolded portion 60 extends longitudinally away from the second end 74b toward the flow channel second end 20b or distal end 13. The second overmolded portion 60 can include a plurality of longitudinal ribs or protrusions 62 protruding inwardly away from the inner periphery. The first end 74a or outer periphery 75b can be inserted into the second end 55b of the base body 55 and fixed (e.g., welded, adhesively bonded and / or adhesively sealed, etc.). The first end 74 a and / or the periphery 75 b of the first end 74 a and / or the second overmold portion 60 may engage / seal against one or more surfaces of the second end 55 b of the base body 55 .

[0063] In some embodiments, the base 50, flow channel 20, and / or device 10 may include a base body 55 having a first end 55a that engages the first connector 72 and / or the first overmolded portion 40 and a second end 55b that engages the second connector 74 and / or the second overmolded portion 60. Figure 5 and Fig.11 As shown, the first end 55a can be telescoped or overlapped with a portion of the first connector 72. The first end 55a can receive the second end 72b of the first connector 72. Figure 5 and Fig.10As shown, the second end 55b may telescope or overlap a portion of the second connector 74. The second end 55b may receive the first end 74a of the second connector 74. The base body 55 may include an inner periphery 55c and an outer periphery 55d. The base body 55 may have a through opening 56 defined by the inner periphery 55c.

[0064] In some embodiments, the cover or first overmolded portion 40 can be overmolded over one or more portions / surfaces of the first connector 72. The first overmolded portion can have a first end 40a and an opposite second end 40b. The first end 40a can engage the front cone 32. The second end 40b can engage or overmold the first connector 72 (e.g., the first end 72a, the flushing port 42). The first end 40a and / or the second end 40b can define at least a portion of the flushing port 42 and / or the flow channel opening 21 alone or in combination with the first connector 72. The second end 40b can be overmolded onto one or more ribs 73e. The through opening 44 can extend through the first overmolded portion 40.

[0065] In some embodiments, the tip or second overmolded portion 60 can be overmolded over one or more portions / surfaces of the second connector 74. The second overmolded portion can have a first end 60a and an opposite second end 60b. The first end 60a can engage or overmold the second connector 74 (e.g., the second end 74b). The second end 60b can surround the horn 14 and / or the distal end 13. The second end 60b can include one or more protrusions / ribs 62 (e.g., longitudinal bumps, spheres, etc.). The first end 60a can be overmolded onto one or more ribs 75h. A through opening 64 can extend through the second overmolded portion 60. The through opening 64 can taper away from the second connector 74 or taper from the first end 60a toward the second end 60b.

[0066] In some embodiments, the flow channel 20, the base 50, the base body 55 and / or the device 10 can include various lengths for various applications of surgical tips 14 with different lengths (e.g., one or more extensions). In order to adjust the length of the flow channel to accommodate various surgical tip lengths, a plurality of base bodies 55 of different lengths can be manufactured and then selected for the application length (e.g., a first flow channel length, a second flow channel length greater than the first flow channel length). For example, the base and / or the base body can be extruded into a predetermined first length. Then, the selected base body 55 having the predetermined first length is overmolded and / or combined with the overmolded connector 70 and 40 / 60 (e.g., a combination of a connector and an overmolded portion). This can produce a first flow channel length for one application. In another application, the selected base body can be a predetermined second length. Then, the selected base body 55 having the predetermined second length is overmolded and / or combined with the overmolded connector 70 and 40 / 60 (e.g., a combination of a connector and an overmolded portion). This may result in a second flow channel length different from the first flow channel length for another application.

[0067] It should be noted that the use of a silicone cover seal or first overmolded portion 40 for a standard nose cone or electrosurgical nose cone configuration supports the high voltage breakdown strength and sealing necessary to prevent the conductive saline from carrying electrical potential to the surgeon or patient anatomy. Similarly, the silicone surgical tip or second overmolded portion 60 supports electrical safety and resistance to arcing and mechanical vibrations from ultrasound. When, for example, RF is combined with the surgical tip for coagulation, the distal silicone rubber or overmolded rubber helps resist erosion and cracking caused by arcing. Pre-test devices and prototypes of fully rigid flow channels did not have the advantages of silicone and quickly failed in testing due to electrosurgical arcing.

[0068] In some embodiments, the flow channel tip or second overmold portion 60 (eg, silicone) can have a high melting point for withstanding ultrasonic energy and electrosurgical arcs. Further, the flow channel tip can have a high dielectric resistance for confining electrosurgical discharge to the working surface.

[0069] In some embodiments, the flow channel cover or first overmold portion 40 (eg, silicone) can have material compliance for friction fit with existing equipment (eg, nose cone). Further, the flow channel cover can have a high dielectric resistance for confining electrosurgical discharge to the working surface.

[0070] In some embodiments, the flow channel body 22 or base body 55 (e.g., polycarbonate) can have reduced friction when inserted through a trocar, thereby eliminating or reducing flow channel elongation and contraction caused by movement of the flow channel through the trocar (e.g., eliminating or reducing visual obstruction of the tip). Further, by adjusting the length of the base body, the extrusion length can be easily modified for laparoscopic tips of different lengths. Further, the flow channel body can have a high dielectric resistance to confine electrosurgical discharge to the working surface.

[0071] In some embodiments, it may be advantageous to overmold one or more overmolded portions (e.g., a first overmolded portion, a second overmolded portion) onto the connector 70 rather than onto the opposite end of the elongated extruded tube or base body. The silicone curing temperature may approach or exceed the glass transition temperature of extrusion grade polycarbonate. Overmolding onto a separate insert / connector may allow the material to be selected for injection molding, which may be more compatible with the preferred silicone curing temperature. This may also simplify the tool, since the total overmolding tool size only needs to accommodate the insert itself, rather than the entire length of the extruded tube or base body, thus simplifying the closure of the core pin on the inner diameter. This may also result in a more modular design, avoiding the need for multiple sets of overmolding tools to produce runners of various lengths. It should be noted that in some embodiments, caution in selecting materials and opacity enables laser welding. Inserts / connectors having black polymers heat up as the laser energy is absorbed, and both heating and welding are caused near a transparent polymer (e.g., base body).

[0072] Laparoscopic surgical tip

[0073] like FIG. 4A to FIG. 4I As shown, one or more laparoscopic surgical tips 14 can have a first horn member 14a, a second horn member 14b, and one or more third horn members 14c (if used) connected with one or more threaded couplings 18. The proximal end of each horn member defines a portion of the coupling 18 to connect the horn members (e.g., horn members 14a, 14b, 14c, etc.) to provide one or more predetermined lengths of the one or more tips 14. In some embodiments, this modular construction allows the central lumen of the gun drill to have sufficient straightness and concentricity over a limited length to maintain uniform and minimal stress at the tapered Gaussian region of the distal end, where material stress is amplified to achieve a relatively large amplitude at the end.

[0074] The connection / coupling of the first horn member 14a, the second horn member 14b, and the one or more third horn members 14c (if used) can be accomplished with a pneumatic vise or chuck, rather than relying on standard flats for tightening with a wrench. This enables one or more horns 14 of one or more lengths to be used in an operating room without being accidentally or intentionally disassembled (e.g., with unauthorized intent to modify the device). In such FIG. 4D to FIG. 4I In some embodiments shown, the horn 14 may include one or more third horn members 14c for one or more lengths or applications. The length of each third horn member 14c may be about 90mm to about 120mm. For example, the length may be 100mm, which is half the wavelength of a 23kHz compression standing wave in titanium. One or more third horn members 14c (if used) may be a half-wavelength stretcher / member / module. In some embodiments, one or more third horn members 14a may have an inner diameter and / or outer diameter different from at least one of the first horn member and the second horn member. At 23kHz, the speed of sound in titanium produces a compression wavelength of about 214mm (e.g., the speed of sound divided by the frequency), half of which is 107mm, i.e., the actual length for the surgical extension. Thus, even taking into account the placement of the trocar, the surgical tip with the extended length of one or more third horn members can be long enough to cover the full range of liver resection. This was tested in a design verification with an acceptable to highly acceptable geometry.

[0075] In some embodiments, it is found that one or more half-wavelength stretchers or third horn members 14c can be added, and the Gaussian tapered section of the surgical tip can be adjusted to obtain resonance and amplitude suitable for surgery. Creating a modular system of tip subcomponents can allow these three or more subcomponents to create two different catalog items simply by adding at least one third horn 14c to create an extended length tip. Although this design approach is useful for scale efficiency, it may allow transverse modes that are highly sensitive to diameter to be suppressed, specifically along the middle section of the device along the extended length. Increasing the diameter will move the transverse modes upward in frequency, while reducing the diameter will move these modes downward. The effect of the stretcher diameter on the longitudinal mode (e.g., 23kHz design frequency) is very small, so modifying the stretcher diameter can be a useful design tool to prevent conflicting error modes from being powered during device operation. Since the second stretcher or third horn member consists of step-up and step-down, the net effect on gain (e.g., stroke) may be minimal.

[0076] It can be noted that the pre-tested CUSA Excel laparoscopic surgical tips are limited in surgical tip amplitude, and the fragmentation capacity for stubborn tissue is related to the square of the amplitude. With the development of laparoscopic surgery, more and more diseased tissues are treated, such as cirrhotic tissue or tissue affected by chemotherapy. The standard and extended laparoscopic surgical tips have an increase of about 15% in surgical tip amplitude and an increase of about 30% in fragmentation capacity. The scope of surgery can be extended to more stubborn tissues.

[0077] In some embodiments, the extended laparoscopic tip can be extended twofold (e.g., there are two third horn members between the first horn member and the second horn member) and / or threefold (e.g., there are three third horn members between the first horn member and the second horn member) to allow very long surgical tips suitable for seamless integration with a robot. A twofold and / or threefold extended tip (e.g., a longer or elongated flow channel / base body having connector 70, molded portion 40 / 60, base body 55) in combination with flow channel 20 can create a surgical tip and flow channel system that is long enough to interface with at least one robot during one or more applications. Embodiments are not limited to twofold or threefold embodiments.

[0078] In some embodiments, the ultrasonic horn 14 may include one or more third horn members 14c interconnected between the first horn member 14a and the second horn member 14b. The length L of the surgical tip 14 (e.g., the first horn member and the second horn member) can be extended using a half-wave extender or a third horn member 14c without significantly changing the basic design. The titanium horn 14 has a wavelength of a resonant frequency divided by the speed of sound, and a half-wavelength is half of the length. For illustration, the third horn member 14c of the current extended diameter has a half-wavelength of about 107mm. An extender or a third horn member 14c with a diameter of about 107mm can be added, for example, via a threaded attachment / coupling 18 at an anti-node. The threaded coupling can be positioned adjacent to the anti-node. This extends the standing wave through the local maximum stress node and then to another anti-node. The resonant frequency and the standing wave may not be affected much by the extender or the third horn member. In some applications, double or two third horn members and / or triple or three horn members may be added and the surgical tip may be enhanced in terms of resonance and tissue fragmentation capabilities. Horn members 14a to 14c (if used) may be "over-torqued" so that surgical tip 14 is virtually impossible to disassemble in the operating room. For example, a horn member 14a to 14c may be added such as FIG. 4D to FIG. 4F A third horn is shown and pneumatically tightened with special equipment.

[0079] In some embodiments, one or more kits can be used for one or more applications. For example, a kit can have one or more flow channels 20 of different lengths (e.g., a first length, a second length, a third length, etc.) and / or one or more horn 14 of different lengths (e.g., a first length, a second length, a third length, etc.).

[0080] Although several inventive embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily conceive of various other devices and / or structures that perform functions and / or obtain results and / or one or more advantages as described herein, and each of such variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications taught by the present invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific inventive embodiments described herein using experiments that do not exceed routine. Therefore, it should be understood that the foregoing embodiments are presented only as examples, and within the scope of the appended claims and their equivalents, embodiments of the present invention may be implemented in a manner different from that specifically described and claimed. Inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if these features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention disclosed herein.

[0081] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0082] Unless expressly indicated to the contrary, the indefinite articles "a" and "an" as used in this specification and the claims should be understood to mean "at least one".

[0083] The phrase "and / or" as used in this specification and claims should be understood to mean "either or both" of the elements so combined, i.e., the elements are present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements are so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising", reference to "A and / or B" may, in one embodiment, refer only to A (optionally including elements other than B); in another embodiment, refer only to B (optionally including elements other than A); in yet another embodiment, refer to both A and B (optionally including other elements); and so on.

[0084] As used in this specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as being inclusive, that is, including at least one, but also including more than one in a plurality of elements or lists of elements, and optional other unlisted items. Only terms that clearly indicate the opposite, such as "only one" or "just one", or, when used in the claims, "consisting of..." will refer to exactly one element of the number or list of elements included. In general, when used before an exclusive term (such as "any one", "one", "only one", or "just one"), the term "or" used herein should only be interpreted as indicating an exclusive alternative (i.e., "one or the other but not both"). When used in the claims, "consisting essentially of..." should have its ordinary meaning used in the field of patent law.

[0085] As used in this specification and claims, with respect to a list of one or more elements, the phrase "at least one" is understood to mean at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one element of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. In addition to the elements specifically identified in the list of elements to which the phrase "at least one" refers, this limitation also allows elements to be optionally present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently "at least one of A and / or B") may refer to at least one (optionally including more than one) A, with no B (and optionally including elements other than B) in one embodiment; to at least one (optionally including more than one) B, with no A (and optionally including elements other than A) in another embodiment; to at least one (optionally including more than one) A and at least one (optionally including more than one) B (and optionally including other elements) in yet another embodiment; and so on.

[0086] It should also be understood that in any method claimed herein that includes more than one step or action, the order of the steps or actions of the method is not necessarily limited to the order in which the steps or actions of the method are recited unless explicitly indicated to the contrary.

[0087] In the above claims and specification, all transitional phrases such as "comprises," "comprising," "carrying," "having," "containing," "involving," "holding," "comprising," and the like shall be construed as open ended, i.e., meaning including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in Section 2111.03 of the U.S. Patent Office Manual of Patent Examining Procedures.

[0088] Without departing from the scope and essential features of the present invention, the present invention may be implemented in other forms. Therefore, the described embodiments are considered to be illustrative and non-restrictive in all aspects. Although the present invention has been described according to some preferred embodiments, other embodiments that are obvious to those of ordinary skill in the art are also within the scope of the present invention.

Claims

1. A flow channel for use with an ultrasonic horn, the flow channel comprising: a base having a first connector and a second connector interconnected by a base body, and wherein the base body includes a first end and an opposite second end, wherein the first end of the base body includes the first connector and the second end of the base body includes the second connector; wherein the first connector comprises a first overmolded portion adapted to engage the front cone; and Wherein, the second connecting member includes a second overmolded portion.

2. The flow channel according to claim 1, wherein: At least one of the first connector and the second connector is secured to the base body by at least one of plastic welding, adhesive bonding, and adhesive sealing.

3. The flow channel according to claim 2, wherein: At least one of the first connector and the second connector is fixed to the base body by the plastic welding and the adhesive bonding.

4. The flow channel according to claim 3, wherein: At least one of the first connector and the second connector is sealed to the base body by the adhesive.

5. The flow channel according to claim 1, wherein: At least one of the first connector and the second connector comprises one or more ribs, and wherein the one or more ribs are overmolded by the first overmolded portion and the second overmolded portion, respectively.

6. The flow channel according to claim 1, wherein: At least one of the first connector and the first overmolded portion defines at least a portion of a flush port.

7. The flow channel according to claim 1, wherein: The second overmolded portion comprises a through opening which tapers away from the second connecting piece.

8. An ultrasonic surgical device for fragmenting tissue and removing the fragmented tissue, the device comprising: A surgical handpiece comprising a housing, a nose cone attached to the housing, a flow channel attached to the nose cone, and a transducer mounted within the housing; a surgical tip connected to the transducer via an internal horn; an irrigation system connected to the handpiece for supplying an irrigation fluid adjacent to the surgical site to suspend disrupted tissue; a suction system connected to the handpiece for aspirating fluid and disrupted tissue at the surgical site; and The flow channel has a first end and an opposite second end, the flow channel includes a base, a first overmolded portion defining the first end, and a second overmolded portion defining the second end.

9. The device according to claim 8, wherein: The base includes a base body having a first end and an opposite second end, a first connector, and a second connector, wherein the first connector is connected to the first end of the base body and the second connector is connected to the second end of the base body.

10. The device according to claim 9, wherein: The first connector includes the first overmolded portion, and the second connector includes the second overmolded portion.

11. The apparatus of claim 10, at least one of the first connector and the second connector comprising one or more ribs engaging the first overmolded portion and the second overmolded portion, respectively.

12. The device according to claim 9, wherein: At least one of the first connector and the second connector is fixed to the first end and the second end of the base body, respectively, by at least one of plastic welding, adhesive bonding, and adhesive sealing.

13. The device according to claim 12, wherein: At least one of the first connector and the second connector is fixed to the first end and the second end of the base body, respectively, by the plastic welding and the adhesive bonding.

14. The device according to claim 13, wherein: At least one of the first connector and the second connector is secured to the first end and the second end of the base body, respectively, by the adhesive seal.

15. The apparatus according to claim 9, wherein: The first connector and the second connector are made of a material different from the first overmolded portion and the second overmolded portion.

16. The apparatus according to claim 9, wherein: The base body is made of a different material than the first overmold portion and the second overmold portion.

17. An ultrasonic horn, comprising: a first horn member; a second horn member; as well as One or more third horn members connecting the first horn member to the second horn member within a predetermined overall length of the horn.

18. The ultrasonic horn according to claim 17, wherein: At least one of the third horn members is half wavelength between about 90 mm and about 120 mm.

19. The ultrasonic horn according to claim 18, wherein: At least one of the third horn members has a half wavelength of approximately 107 mm.

20. The ultrasonic horn according to claim 17, wherein: The third horn member is positioned at the anti-node.

21. The ultrasonic horn of claim 17, further comprising a threaded coupling between the third horn member and each of the first and second horn members.

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