Fluid delivery tube for ultrasonic surgical horn
The hybrid fluid delivery barrel design for ultrasonic surgical aspirators addresses friction and visibility issues by combining overmolded silicone with rigid materials, improving the effectiveness of tissue fragmentation and coagulation during surgical procedures.
Patent Information
- Application Number
- JP2024565291
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-10
- Filing Date
- 2023-05-10
- Publication Date
- 2025-05-20
AI Technical Summary
Existing ultrasonic surgical aspirators face issues with friction, stiffness, and visibility during surgical procedures, particularly when used through trocars, which can cause deflection and obscure the working surface.
A hybrid fluid delivery barrel design combining overmolded silicone sections with rigid polycarbonate or similar materials, secured by plastic welding and adhesive bonding, to enhance stiffness, reduce friction, and maintain visibility, while supporting ultrasonic and radio frequency energy transmission for tissue fragmentation and coagulation.
The hybrid delivery barrel design reduces friction and deflection, maintains visibility, and ensures effective energy transmission, enhancing the performance of ultrasonic surgical aspirators in surgical procedures.
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Figure 2025515667000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates generally to ultrasonic surgical devices, and more particularly to ultrasonic surgical aspirators for removing diseased tissue. [Background technology]
[0002] Devices that effectively utilize ultrasonic energy for various applications are well known in several diverse technical fields. One of these devices is an ultrasonic horn or tip used for tissue removal. The Ampulla, or Gaussian profile, was published by Kleesattel as early as 1962 and has been adopted as the basis for many ultrasonic horns in surgical applications, including devices for use in ultrasonic aspiration, as described in U.S. Pat. No. 4,063,557 to Wuchinich, et al. (1977) and U.S. Pat. No. 6,214,017 to Stoddard, et al. (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, connecting body, and horn work together as a three-body system to provide mechanical gain, 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 strain induced in the materials from which the resonator, connecting body, and ultrasonic horn are constructed.
[0003] A magnetostrictive or piezoelectric transducer coupled with a connecting body serves as the first stage of the booster horn with a mechanical gain of about 2:1 due to the reduction in the area ratio of the walls of the complex geometry. The outermost diameter of the horn transitions to a large diameter Gaussian section in a stepped horn geometry with a gain as large as about 5:1, again due to the reduction in the area ratio. Uniform strain along the length of the Gaussian section typically provides a multiplicative gain of less than 2:1. Thus, the application of ultrasonic vibration surgical devices used to fragment and remove unwanted tissue with significant precision and safety has led to the development of several valuable surgical techniques.
[0004] Certain devices known in the art characteristically produce continuous vibrations having a substantially constant amplitude at a predetermined frequency, for example, 20-36 kHz, at a frequency of about 20 to about 55 kHz. The amplitude of the transducer surgical tip system decreases with increasing frequency because the maximum stress in the material of the horn is proportional to the amplitude times the frequency, and the material must be maintained at an acceptable ratio of its yield strength to support the rated life in light of the fatigue limit of the material. For example, U.S. Patent Nos. 4,063,557, 4,223,676, and 4,425,115 (incorporated herein by reference) disclose devices suitable for the removal of soft tissue, particularly adapted for removing highly pliable elastic tissue mixed with blood. Such devices are adapted to be operated continuously, typically operated by a foot switch, when the surgeon desires to fragment and remove tissue.
[0005] Ultrasonic aspiration is becoming the standard of care for the removal of tumors and diseased tissue in neurosurgery and general surgery. Typically, an ultrasonic surgical aspirator for fragmenting and aspirating tissue includes an ultrasonic transducer supported in a handpiece, an ultrasonic vibrating horn or tip operatively connected to the ultrasonic transducer, and a sleeve or suction tube positioned about the horn. The horn includes a longitudinally extending central bore having one end positioned adjacent the distal tip of the horn and a second end positioned adjacent its proximal end. The proximal end of the horn is adapted to engage a vacuum source and facilitate aspirating fluid. The suction tube is positioned about the horn and defines an annular passage. Irrigation fluid is delivered to the surgical site through the annular passage around the horn, where it mixes with blood and tissue particles and is aspirated through the bore in the horn. By mixing the irrigation fluid with the blood and tissue particles, blood clotting is slowed and aspiration is assisted. 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 may be powered by a transducer to fragment tissue and aspirate waste fluid through a central channel. A fluid delivery tube is employed to deliver irrigation fluid, usually saline, which shields the tissue along a path from the vibrating surgical tip to the surgical site. The transducer vibrates along its length, and an ultrasonic horn, such as a stepped horn and a characteristic profile of reduced diameter, amplifies the vibrations.
[0006] A known instrument sold for ultrasonic fragmentation of tissue at a surgical site and aspiration of tissue particles and fluids away from the site is the CUSA® Excel ultrasonic surgical aspirator (Integra LifeSciences Corporation, Plainsboro, NJ). When a longitudinally vibrating tip in such an aspirator is brought into contact with tissue, it gently, selectively, and precisely fragments and removes the tissue. The CUSA transducer amplitude can be adjusted independent of frequency, and this amplitude can be maintained under load depending on the transducer's power reserve. In simple harmonic motion devices, frequency is independent of amplitude. Advantages of this unique surgical instrument include minimal damage to healthy tissue in tumor removal procedures, vascular skeleton extraction, immediate healing of tissue, minimal heating or tearing of surrounding tissue edges, minimal retraction of healthy tissue, and excellent tactile feedback for selectively controlled tissue fragmentation and removal.
[0007] In a device for fragmenting tissue by ultrasonic vibration of a tool tip, the efficiency of energy utilization is optimized when the transducer providing the ultrasonic vibrations operates at a resonant frequency. The transducer and surgical tip design establish the resonant frequency of the system, while the generator produces an electrical drive signal to track the resonant frequency and vibrate the transducer at the resonant frequency. However, changes in operating parameters such as temperature, thermal expansion, and changes in load impedance cause the resonant frequency to deviate. Therefore, a controlled change in the frequency of the drive signal is required to track the resonant frequency. This is automatically controlled within the generator.
[0008] Conventional ultrasonic surgical aspirator tips, employed for many years in surgery, typically present a longitudinally vibrating annular surface with a central channel that contacts tissue and provides suction or aspiration, allowing fragmentation via the described mechanisms of mechanical impulse (momentum), cavitation, and ultrasonic propagation. Mechanical impulse may be most useful in soft tissues, while cavitation contributes distinctly to the fragmentation of stubborn hard tissues in situations where liquid is present and high intensity ultrasound exceeds the cavitation threshold. When tissue ablation surgery is performed, an ultrasonic surgical aspirator may be inserted into the patient through a trocar. Once inserted, the surgeon may use the activated ultrasonic tip to fragment and aspirate tissue at the surgical site. A fluid delivery barrel may deliver irrigation to the surgical site in laparoscopic surgical applications. The fluid delivery barrel may act as a protective barrier between the active ultrasonic tip and the trocar and / or the human body.
[0009] Ultrasonic propagation involves the transmission of pressure across the surgical tip and tissue boundaries, which leads to pressure propagation and, perhaps more importantly, particle displacement. Acoustic impedance is the total response of acoustic transmission through a medium, represented by the complex ratio of pressure to effective flux, i.e., particle velocity times the surface area through the medium. For the case of a low-to-high acoustic impedance boundary, as discussed in Krautkramer J. and Krautkramer H's classic text, "ULTRASONIC TESTING OF MATERIALS," Berlin, Heidelberg, NY (1983), it may seem paradoxical that the transmitted pressure can exceed 100%, but this results from the accumulation of pressure from the low-to-high acoustic impedance boundary. In the case of a high to low acoustic impedance mismatch, such as from a high impedance titanium ultrasound horn to low impedance fibrous muscle, soft tissue, or water, the transmitted pressure decreases (e.g., less than 15% for titanium to fibrous muscle) and particle displacement increases (e.g., as much as 186% for titanium to muscle).
[0010] A typical all-silicone delivery barrel can undergo longitudinal deflection during movement through the trocar and visually obscure the working surface of the ultrasonic tip. Silicone rubber has a high coefficient of friction, low stiffness, and drag within the trocar, resulting in substantial total deflection when this frictional force is applied over a long length of silicone.
[0011] Thus, those skilled in the art have recognized a need to reduce friction, increase stiffness, reduce stretch caused by trocars, and / or maintain visibility of the distal end throughout a surgical procedure. The present invention meets this need and others. [Prior art documents] [Patent documents]
[0012] [Patent Document 1] U.S. Pat. No. 4,063,557 [Patent Document 2] U.S. Patent No. 6,214,017 [Patent Document 3] U.S. Pat. No. 4,063,557 [Patent Document 4] U.S. Pat. No. 4,223,676 [Patent Document 5] U.S. Pat. No. 4,425,115 [Patent Document 6] U.S. Pat. No. 5,015,227 [Patent Document 7] U.S. Pat. No. 4,988,334 Summary of the Invention [Means for solving the problem]
[0013] In some embodiments of the invention, for example, a fluid delivery barrel 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 opposing second end. In some embodiments, the first end of the base body may include the first connector and the second end of the base body may include the second connector. In some embodiments, the first connector may include a first overmolded portion adapted to engage a nose cone. In various embodiments, the second connector may include a second overmolded portion.
[0014] Additionally, in some embodiments, at least one of the first connector and the second connector may be secured 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 may be secured to the base body by plastic welding and adhesive bonding. In some embodiments, at least one of the first connector and the second connector may be secured 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, which are overmolded by the first overmolded portion and the second overmolded portion, respectively. In some embodiments, at least one of the first connector and the first overmolded portion may define at least a portion of the irrigation port. In various embodiments, the second overmolded portion may include a through opening that narrows away from the second connector.
[0015] In some embodiments, an ultrasonic surgical device for fragmenting tissue and removing the fragmented tissue may include a surgical handpiece comprising a housing, a nose cone attached to the housing, a fluid delivery barrel 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 to provide irrigation fluid adjacent the surgical site to suspend the fragmented tissue. In various embodiments, the device may include an aspiration system connected to the handpiece to aspirate fluid and the fragmented tissue at the surgical site. In some embodiments, the fluid delivery barrel may have a first end and an opposing second end. In various embodiments, the fluid delivery barrel may include a base, a first overmolded portion defining the first end, and / or a second overmolded portion defining the second end.
[0016] Additionally, in some embodiments, the base may include a base body having a first end and an opposing 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 secured to the first end and the second end of the base body, respectively, by at least one of a plastic weld, an adhesive bond, and / or an adhesive seal. In various embodiments, at least one of the first connector and the second connector may be secured to the first and second ends of the base body by plastic welding and adhesive bonding, respectively. In some embodiments, at least one of the first connector and the second connector may be secured to the first and second ends of the base body by adhesive sealing, respectively. In various embodiments, the first connector and the second connector may be made of a different material than the first and second overmolded parts. In some embodiments, the base body may be made of a different material than the first and second overmolded parts. In some embodiments, the proximal seal may be eliminated and instead a complete sealed rigid (e.g., polycarbonate, etc.) section may be included.Overall, the embodiments comprise a composite or hybrid delivery barrel (from an overmolded proximal seal material such as silicone, to a rigid section such as polycarbonate, a distal overmolded seal portion, and an arc resistant material such as silicone) that supports the propagation and transmission of ultrasonic and radio frequency (RF) energy required for tissue fragmentation and coagulation in surgery. The hybrid delivery barrel and expandable surgical tip combination supports the longest standing phacoemulsifier instruments in the art.
[0017] In some embodiments, a method for attaching a member of an ultrasonic surgical device may include providing a nose cone. In various embodiments, the method may include providing a first feed barrel having a first length. In some embodiments, the first feed barrel may include one or more overmolded portions on a first connector and a second connector, the first connector and the second connector being attached to each end of the first base body. In some embodiments, the method may include providing a hand piece having a body. In various embodiments, the method may include providing a tip. In some embodiments, the method may include connecting a nose cone to the hand piece.
[0018] Additionally, in various embodiments, the method may include providing a second send barrel having a second length different from the first length, the second send barrel including one or more overmolded portions on the first connector and the second connector, the first connector and the second connector being attached to each end of the second base body. In some embodiments, the method may include connecting at least one of the first send barrel and the second send barrel to a nose cone. In various embodiments, the method may include connecting the first send barrel to the nose cone.
[0019] In some embodiments, the method for attaching a member of a fluid supply barrel 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.
[0020] Additionally, 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, overmolding the first overmolded portion and the second overmolded portion onto the first connector and the second connector, respectively, may occur before 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 onto one or more ribs that project outwardly from the periphery of the first connector and the second connector, respectively. In various embodiments, the first connector and the first overmolded portion may each define at least a portion of an irrigation port. In some embodiments, the method may include varying a length of the base body from a first end to a second end and varying a length of the delivery barrel.
[0021] In some embodiments, the ultrasonic horn may include a first horn member, a second horn member, and / or one or more third horn members connecting the first horn member to the second horn member along a predetermined length of the horn.
[0022] Additionally, in some embodiments, at least one of the third horn members may be approximately 107 mm half wavelength. In various embodiments, the third horn member may be positioned at an antinode. In some embodiments, the method may include a threaded coupling between the third horn member and a respective one of the first horn member and the second horn member.
[0023] In some embodiments, the method of varying the length of the ultrasonic horn may include 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 overall length of the ultrasonic horn. In some embodiments, the method may include selecting one or more third horn members to achieve the overall length of the ultrasonic horn. In various embodiments, the method may include coupling one or more third horn members between the first horn member and the second horn member. Such a delivery barrel and expandable surgical tip may result in the longest ultrasonic aspirator surgical instrument in the art.
[0024] Additionally, in some embodiments, the coupling may be a threaded engagement. In various embodiments, the method may include pneumatically fastening the one or more third horn members with specialized equipment. In various embodiments, the method may include overtorquing the coupling. In some embodiments, the coupling may be adjacent to the antinode.
[0025] Other features and advantages of the present invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying illustrative drawings. [Brief description of the drawings]
[0026] In the drawings, like reference characters 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.
[0027] Embodiments of the presently disclosed ultrasonic horn are described herein with reference to the drawings.
[0028] [Figure 1] FIG. 1 is a perspective view of an ultrasound device in accordance with the present invention.
[0029] [Diagram 2] FIG. 2 illustrates the proximal end of the device of FIG. 1 in greater detail.
[0030] [Diagram 3] FIG. 3 is a perspective view of the nose cone fully assembled to the handpiece / nose cone and supporting the fluid carry tube (the fluid carry tube is not shown in this drawing).
[0031] [Figure 4A] FIG. 4A is a perspective view of one embodiment of an ultrasonic horn.
[0032] [Figure 4B] FIG. 4B is an exploded view of the ultrasonic horn of FIG. 4A.
[0033] [Figure 4C] FIG. 4C is a side cross-sectional view of the ultrasonic horn of FIG. 4A.
[0034] [Figure 4D]FIG. 4D is a perspective view of another embodiment of an ultrasonic horn illustrating a third horn member that increases the length of the horn compared to the horn shown in FIG. 4A.
[0035] [Figure 4E] FIG. 4E is an exploded view of the ultrasonic horn of FIG. 4D.
[0036] [Figure 4F] FIG. 4F is a side cross-sectional view of the ultrasonic horn of FIG. 4D.
[0037] [Figure 4G] FIG. 4G is a perspective view of another embodiment of an ultrasonic horn illustrating two third horn members that increase the length of the horn compared to the horn shown in FIG. 4D.
[0038] [Figure 4H] FIG. 4H is an exploded view of the ultrasonic horn of FIG. 4G.
[0039] [Figure 4I] FIG. 4I is a side cross-sectional view of the ultrasonic horn of FIG. 4G.
[0040] [Diagram 5] FIG. 5 is a cross-sectional view of one embodiment of a fluid delivery barrel according to the present invention (the fluid delivery barrel tube is not shown in this drawing).
[0041] [Figure 6A] FIG. 6A shows a perspective view of an embodiment of the first connector.
[0042] [Figure 6B] FIG. 6B shows another perspective view of the first connector of FIG. 6A.
[0043] [Figure 6C] FIG. 6C shows a perspective view of an embodiment of the second connector.
[0044] [Figure 6D] FIG. 6D shows another perspective view of the second connector of FIG. 6C.
[0045] [Figure 7A] FIG. 7A shows a perspective view of the first connector of FIG. 6A combined with an embodiment of a first overmolded portion.
[0046] [Figure 7B] FIG. 7B shows a perspective view of the second connector of FIG. 6C combined with an embodiment of a second overmolded portion.
[0047] [Figure 8] 8A-8F illustrate multiple views of the first connector of FIG. 6A.
[0048] [Figure 9] 9A-9F illustrate multiple views of the second connector of FIG. 6C.
[0049] [Figure 10] FIG. 10 is an enlarged cross-sectional view of one embodiment of a connection between the second connector and the base body.
[0050] [Figure 11] FIG. 11 is an enlarged cross-sectional view of one embodiment of a connection between the first connector and the base body. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0051] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the presently disclosed ultrasonic horn will now be described in detail with reference to the drawings, in which like reference numbers designate the same or corresponding elements in each of the several views. As used herein, the term "distal" refers to that portion of the instrument or its component that is further from the user during normal use, while the term "proximal" refers to that portion of the instrument or its component that is closer to the user. The terms "ultrasonic horn", "ultrasonic tip", "ultrasonic aspirating tip", "ultrasonic surgical aspirating tip", "aspirating tip", "ultrasonic surgical tip", "surgical tip", and "tip" are used interchangeably herein. The type of energy that can be used is primarily discussed as "ultrasonic", but can also include radio frequency (RF) energy. The terms "delivery barrel", "irrigation delivery barrel", "sleeve", "irrigation manifold", and "manifold" are used interchangeably herein. The terms "tip dilator" and "horn dilator" are used interchangeably herein.
[0052] 1-3, one embodiment of the presently disclosed device for ultrasonically fragmenting and aspirating tissue is shown. The present disclosure is directed to an ultrasonic surgical device 10 for ultrasonically fragmenting and aspirating tissue in a surgical procedure. Generally, the ultrasonic surgical device includes a handpiece 12, which is used by a surgeon to direct the fragmentation. The handpiece 12 encloses a transducer (not shown) to which a surgical tip or ultrasonic horn 14 is fastened. The ultrasonic horn is powered by the transducer and can be ultrasonically actuated to fragment tissue and aspirate waste fluid through a central channel. A distal end 13 of the ultrasonic horn 14, or a portion thereof, extends beyond the distal end of the fluid delivery barrel 20. The ultrasonic horn 14 is vibrated to fragment tissue during a surgical procedure. The ultrasonic horn may be made of titanium or other conventional materials known in the art.
[0053] A cooling and irrigation system is provided that provides cooling fluid to the ultrasonic horn 14 to maintain the temperature within an acceptable range. The handpiece 12 includes a housing 15, which may be formed from a sterilizable plastic or metal, but is preferably plastic. A suction tube 20 provides a path for irrigation fluid or liquid and is connected to the distal end of the housing 15. The suction tube 20 typically connects to the handpiece 12 via a nose cone 32. The suction tube 20 may include or be attached to a suction tube tube 16 and be in fluid communication with the suction tube tube 16 through an opening 21. The nose cone 32 is attached to the handpiece 12 and covers an interior portion of the ultrasonic horn 14.
[0054] Irrigation tubing 22 connects upstream to the sender tube 16 and supplies irrigation fluid to the surgical site through the sender tube 16 during a surgical procedure. A suction tube 24 provides suction force and a path for aspiration from the surgical site to a collection canister (not shown). Alternatively, the suction tube may be mounted external to the housing 15. A sender tube clip 19 allows adjustment of the location of the sender tube 16 depending on the location preferred by the surgeon during surgery. Also shown is an electrical cable 26 for providing power to the device or for providing a switched connection.
[0055] 4A-4C illustrate one embodiment of an ultrasonic horn 14 suitable for use with the ultrasonic surgical device described above for fragmenting and aspirating tissue. The ultrasonic horn has an exterior surface 120 and includes a first horn, i.e., proximal member 14a, and a second horn, i.e., distal member 14b, extending distally from the first horn, i.e., proximal member. The first horn member 14a is coupled / connected to the second horn member 14b by a threaded coupling 18 (e.g., male / female connection), although it should be understood that various connections / couplings or methods of combining two or more horn members (e.g., 14a, 14b, 14c, etc.) may also be used. For example, the threaded coupling 18, if used, may be over-torqued and / or laser welded. In some embodiments, the couplings of one or more of the horn members may be press-fit. Press fits, if used, may be laser welded and / or electron beam welded connections. Another example of a press fit may be secured using a pin. In one embodiment shown, the first horn member 14a may include female or tapped threads on a distal end and the second horn member 14b may include male threads on a proximal end to define a threaded coupling 18. As shown in Figures 4D-4I, the ultrasonic horn 14 may have one or more additional horns, modules, or members 14c (e.g., a third horn member 14c) to vary the (e.g., overall) length of the horn for one or more applications. In one embodiment shown, the third horn member 14c may include female or tapped threads on a distal end and male threads on a proximal end to define a threaded coupling 18 or a portion thereof. The ultrasonic horn 14 has a distal end portion 13, a threaded proximal end 111, a through bore 117, a pre-suction hole or transverse bore 115, and a hexagonal engagement portion 119. The ultrasonic horn may have a larger outer diameter in the first horn, i.e., proximal member 14a section, and a smaller outer diameter in the second horn, i.e., distal member 14b section.
[0056] Although the ultrasonic horn as shown is not stepped, ultrasonic horns that are stepped are known to exist. 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. The single long horn dilator may have a constant outer diameter throughout its length or a diameter that varies gradually along its length, e.g., a diameter that decreases gradually along its length toward the distal end. In addition, one or more horns / members may form a step from another horn / member or transition smoothly therefrom without any obvious step. The ultrasonic horn may vibrate within the ultrasonic frequency range with a longitudinal amplitude of about 5 mils (0.005 inches) to greater than 14 mils (0.014 inches).
[0057] The through bore 117 may also have a larger diameter section in the first horn 14a and a smaller diameter section in the second horn 14b. The diameter of the proximal larger diameter portion of the first horn, the distal smaller diameter portion of the second horn, or the one or more third members of the through bore, if used, may have any suitable diameter as may be readily determined as appropriate by one of ordinary skill in the art. For example, the distal smaller diameter through bore portion may be about 0.078 inches in diameter. The through bore does not necessarily have to correspond to the geometry of the one or more members / horns. The through bore may have two or more diameters in a stepped manner or otherwise, a constant diameter throughout its length, or a diameter that varies (e.g., decreases) gradually along its length toward the distal end.
[0058] The ultrasonic horn 14 is generally circular in cross section and disposed within the fluid supply barrel 20. During operation of the ultrasonic device 10, irrigation fluid is supplied into the fluid supply barrel 20 through the opening 21. The fluid supply barrel 20 and the ultrasonic horn 14 define an annular cavity 36 therebetween. Irrigation fluid is supplied from the fluid supply barrel 20 through the cavity 36 to the distal end of the ultrasonic horn 14. A transverse bore is formed in the pre-aspiration hole 115 near the distal end of the ultrasonic horn 14 and communicates with the through bore 117. Irrigation fluid, along with fragmented tissue, blood, etc., is drawn from the pre-aspiration hole 115 and the surgical site into the inlet 31 of the through bore 117 and removed from the surgical site via the through bore 117 and the aspiration tube 24. The transverse bore provides an alternative route for fluid to enter the through bore 117 if the inlet 31 becomes blocked or obstructed by the tissue intended to be removed. The pre-suction holes 115 ensure that a substantial amount of irrigation is available in the continuous cooling circuit. The irrigation also helps to prevent or reduce the immediate clotting of blood that may block the channels or become occluded by the tissue that is intended to be removed. The pre-suction holes 115 ensure that a substantial amount of irrigation is available in the continuous cooling circuit. The irrigation also helps to prevent or reduce the immediate clotting of blood that may block the channels.
[0059] In a more detailed aspect, irrigation liquid, e.g., saline, is required to cool the surgical tip and site of tissue fragmentation. This irrigation liquid can be provided to the inlet tube using a peristaltic pump at a rate as low as 2-3 ml / min, typically only about 1 or 2 drops per second. The irrigation liquid is provided at the proximal end of the ultrasonic horn. The irrigation liquid travels to the vicinity of the distal end of the ultrasonic horn where two pre-aspiration holes of 0.015 inch diameter aspirate the majority of the irrigation liquid, perhaps 90-95%, through holes connecting the outer horn diameter to a central aspiration channel. This action of irrigation and aspiration supports a continuous cooling circuit for the vibrating titanium metal, which also helps to wet waste fluids such as blood and tissue in the central channel. Some irrigation is also preferred to cool the surgical site, improve binding to the tissue, and provide the cavitation necessary for emulsification and aspiration of tissue such as tumors.
[0060] In some implementations, two or more components and / or shots of material may be overmolded together to produce the feed barrel. The ultrasonic surgical instrument 10 of FIG. 1 illustrates an overmolded feed barrel 20 extending from the nosecone 32 or portion of the device toward the end 13 of the surgical tip 14. As shown in FIGS. 1-3 and 5-12E, the feed barrel 20 may include at least one overmolded shot of material (e.g., the same or different) to produce the feed barrel. The feed barrel 20 may include a base 50 or a portion thereof (e.g., base body 55, connector 70) and one or more overmolded portions 40, 60. The feed barrel 20 and / or body 22 may include opposing ends, i.e., one end 20a adjacent the nosecone 32 and the other or free end 20b adjacent the free end 13 of the surgical tip 14 (e.g., bone tip). In one embodiment shown in FIGS. 5, 10, and 11, the overmolded portions 40, 60 may be adjacent to each end 20a, 20b of the barrel 20, the connector 70 (e.g., 72, 74), and / or the base 50 (e.g., 50a, 50b). The overmolded portions may include a first overmolded portion 40 and a second overmolded portion 60. The first overmolded portion, i.e., the barrel boot 40, may be adjacent to the first end 50a of the base 50 and / or the first end 20a of the barrel / body 22. The first overmolded portion 40 (e.g., the second end 40b) may be overmolded onto the base 50 or a portion thereof (e.g., 70, 72). The second overmolded portion, i.e., barrel tip 60, may be adjacent second end 50b of base 50 and / or second end 20b of barrel / body 22. The second overmolded portion 60 (e.g., first end 60a) may be overmolded onto base 50 or a portion thereof (e.g., 70, 74). The first overmolded portion 40 of barrel 20 may include molded irrigation port 42 and / or a portion of barrel opening 21, or the like.The second overmolded portion 60 (e.g., second end 60b) of the barrel 20 may narrow in a direction from the base 50 (e.g., base body 55, second connector 74) toward the open free end 20b of the barrel surrounding or adjacent the surgical tip end 13. In some embodiments, the base 50, or a portion thereof, may narrow toward the overmolded portion 60 of the barrel 20 or the barrel free end 20b. In various embodiments, the base 50 (e.g., base body 55) may be of constant diameter (e.g., inner circumference and / or outer circumference). The inner circumference 55c may define a through opening 56. In some embodiments, the first overmolded portion 40 and the second overmolded portion 60 may be made of one or more materials (e.g., silicone, polycarbonate, acetal, nylon, Radel®, and the like). The first overmolded portion, i.e., the flume boot 40, may be made from a first material. The second overmolded portion, i.e., the flume tip 60, may be made from a second material. The first and second materials may 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 may be made from the same or different materials. For example, the first and second materials may both be made from silicone. Furthermore, the first overmolded portion and the second overmolded portion may be made in a single overmolding shot over the base 50 or a portion thereof (e.g., the base body 55 and / or the connector 70). Alternatively, the first overmolded portion 40 and the second overmolded portion 60 may be made or overmolded together (e.g., the base body 55 and / or the connector 70) in two or more different shots.As shown in one embodiment, the first overmolded portion 40 and the second overmolded portion 60 may be fabricated or overmolded over their respective connectors 70 (e.g., first connector 72, second connector 74) in one or more shots of material (e.g., silicone over polycarbonate).
[0061] In some implementations, the barrel 20, the base 50, the base body 55 and / or the device 10 may include one or more connectors 70 interconnecting the first overmolded portion 40 and / or the second overmolded portion 60 to the base body 55. In one embodiment shown in FIGS. 5-11, the base 50 may include the base body 55, a first / proximal connector / coupler 72, and / or a second / distal connector / coupler 74. The base 50 and / or the base body 55 may be made from, but not limited to, polycarbonate, acetal, nylon, Radel®, and / or any other extrudable or fiber-filled polymer. Such rigid sections can be extruded in a commonly known process and expanded as needed for surgical tips of different lengths. In some embodiments, the base 50 and / or the base body 55 may be an extruded tube. The connectors 70 (e.g., 72 and / or 74) may be made from, but are not limited to, polycarbonate, acetal, nylon, Radel®, and / or any other extrudable or fiber-filled polymer. The base body 55 and / or connectors 70 may have a rigidity that may eliminate or reduce longitudinal deflection of the device 10 / flush 20 or portions thereof (e.g., during movement through a trocar). In some embodiments, the base body 55 and / or connectors 70 may have a rigidity in the range of about 100,000 psi to about 350,000 psi. The base body 55 may include a first end 55a adjacent the first end 20a of the flush 20 and a second end 55b adjacent the second end 20b of the flush 20. The first connector 72, if used, may be adjacent the first end 55a of the base body 55. If used, the second connector 74 may be adjacent the second end 55b of the base body 55. If used, the first overmold part 40 may be overmolded onto the first connector 72. If used, the second overmold part 60 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 may be molded over the polycarbonate of the first and second polycarbonate connectors 72, 74, respectively. One or more combined connectors 70 and overmolded portions 40, 60 may then be combined / secured / attached to opposing ends 55a, 55b, respectively, of the base body 55. Although not shown, the connector 70 may be attached to the base body 55 and then overmolded with one or more overmolded portions 40, 60 (e.g., first overmolded portion, 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 may be plastic / laser welded, adhesively bonded, and / or sealed (adhesive) to the base body 55 (e.g., first end 55a, second end 55b). One example of an adhesive for sealing / bonding the adhesive between the portions of the base may be, but is not limited to, LOCTITE brand adhesive. The one or more connectors 70 may only be plastic / laser welded to one or more ends 55a, 55b of the base body 55. The one or more connectors 70 may only be adhesively bonded to one or more ends 55a, 55b of the base body 55. The one or more connectors 70 may be plastic / laser welded and adhesively bonded to one or more ends of the base body. The weld and / or adhesive bond may be circumferential (e.g., 360 degrees) around the entire outer / inner circumference as shown in one embodiment or portion thereof. Additionally, an adhesive seal, if used, may occur after the plastic / laser weld and / or adhesive bond. The use of an adhesive sealant at the plastic weld and / or adhesive bond seam, if applicable, may be used as a secondary measure to seal inconsistencies within the laser / weld process, thereby improving the insulation resistance of the seam for electrosurgical safety.In some embodiments, an adhesive sealant may be applied to a portion of the overmolded portion. As shown in one embodiment in Figures 10 and 11, plastic / laser welded areas / portions 27, adhesive bond areas / portions 28, and / or seal areas / portions 29 (e.g., adhesive) are used to connect one or more portions of the base body 55 and one or more portions of the connector / overmolded portion.
[0062] In some implementations, the base 50, the barrel 20, the base body 55, and / or the device 10 may include at least a first connector 72. As shown in FIGS. 5, 6A, 6B, 7A, and 8A-8F, the first connector 72 may include a first end 72a adjacent the first overmolded portion 40 (e.g., second end 40b) and an opposing second end 72b adjacent the base body 55 (e.g., 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 decrease or step in diameter from the first end 72a to the second end 72b. Gate 73d, if used, may be located on periphery 73b (e.g., adjacent one or more ribs 73e). First connector 72 may contain / define molded irrigation port 42 and / or a portion of opening 21, etc. As shown in one embodiment, port 42 may be located from inner periphery 73a through periphery 73b (e.g., larger diameter step) and project outwardly therefrom. First connector 72 may include one or more annular ribs 73e projecting outwardly from periphery 73b (e.g., larger diameter step). Ribs 73e may be continuous about the periphery as shown in one embodiment. However, the ribs may not extend 360 degrees about the periphery in some embodiments. Ribs 73e may be longitudinally spaced apart from one another. An outer periphery 73b of a first end 72a (e.g., one or more annular ribs, ports) of the first connector 72 may be overmolded with a portion of the first overmolded part 40. The first overmolded part 40 may project longitudinally from the first end 72a toward the nosecone 32 and / or radially outward from the outer periphery 73b. The first overmolded part 40 may cover an end surface, i.e., a radial step 73f, facing toward the base body 55 between the larger and smaller diameter outer periphery portions.If used, there may be a squeeze rib 73g surrounding the smaller diameter outer periphery 73b spaced from the step 73f adjacent the longitudinal extent of the first overmolded portion. The first connector 72 (e.g., second end 72b or smaller diameter outer periphery) may be inserted into the first end 55a of the base body 55 and secured (e.g., welded, adhesively bonded, and / or sealed with an adhesive, etc.). An internal step extending radially outward from the first end 72a and the outer periphery of the first connector may define an end surface 73h. One or more portions of the end surface 73h may engage / seal against the nosecone 32. The first overmolded portion 40 or a portion thereof (e.g., inner periphery, longitudinal end surface facing toward the nosecone) may seal against one or more surfaces of the nosecone 32.
[0063] In some implementations, the base 50, the barrel 20, the base body 55, and / or the device 10 may include at least one second connector 74. As shown in FIGS. 5, 6C, 6D, 7B, and 9A-9F, the second connector 74 may include a first end 74a adjacent the base body 55 (e.g., second end 55b) and an opposing second end 74b adjacent the second overmolded portion 60 (e.g., first end 60a). The second connector 74 may include an inner periphery 75a defining a through opening 74c. The through opening 74c may be tapered from the first end 74a to the second end 74b. The second connector 74 may include an outer periphery 75b. Each end 74a, 74b of the second connector 74 may decrease in diameter away from the center or collar 74d. Gate 75d, if used, may be located on periphery 75b (e.g., adjacent one or more ribs 75e). Second connector 74 may include one or more annular ribs 75e projecting outwardly from periphery 75b (e.g., second end 74b). Ribs 75e may be continuous about the periphery as shown in one embodiment. However, the ribs may not extend 360 degrees about the periphery in some embodiments. Ribs 75e may be longitudinally spaced apart from one another. Periphery 75b of second end 74b (e.g., one or more annular ribs) of second connector 74 may be overmolded by a portion of second overmolded portion 60. The second overmolded portion 60 may cover an end surface 75f extending toward the second overmolded portion 60 adjacent the second end 74b, and / or an end surface, i.e., a radial step 75g, facing toward the second overmolded portion 60 adjacent the larger diameter collar. If used, there may be a squeeze rib 75h surrounding the collar periphery 75b adjacent the step 75g adjacent the longitudinal extent of the second overmolded portion. The second overmolded portion 60 extends longitudinally away from the second end 74b toward the second end 20b or distal end 13 of the feed barrel.The second overmolded portion 60 may include a plurality of longitudinal ribs or protrusions 62 that project inwardly away from the inner periphery. The first end 74a or the outer periphery 75b may be inserted into and secured (e.g., welded, adhesively bonded, and / or sealed with an adhesive, etc.) to the second end 55b of the base body 55. The first end 74a and / or the outer periphery 75b of the first end 74a and / or the second overmolded portion 60 may engage / seal against one or more surfaces of the second end 55b of the base body 55.
[0064] In some embodiments, the base 50, the sender barrel 20, and / or the 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. As shown in FIGS. 5 and 11, the first end 55a may freely extend with or overlap a portion of the first connector 72. The first end 55a may receive a second end 72b of the first connector 72. As shown in FIGS. 5 and 10, the second end 55b may freely extend with or overlap a portion of the second connector 74. The second end 55b may receive a 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 an opening 56 therethrough defined by an inner periphery 55c.
[0065] In some implementations, the boot, i.e., first overmolded portion 40, may be overmolded over one or more portions / surfaces of the first connector 72. The first overmolded portion may have a first end 40a and an opposing second end 40b. The first end 40a may engage the nosecone 32. The second end 40b may engage or overmold the first connector 72 (e.g., first end 72a, irrigation port 42). The first end 40a and / or second end 40b may define at least a portion of the irrigation port 42 and / or the inlet tube opening 21, alone or in combination with the first connector 72. The second end 40b may be overmolded over one or more ribs 73e. A through opening 44 may extend through the first overmolded portion 40.
[0066] In some implementations, the tip, i.e., second overmolded portion 60, may be overmolded over one or more portions / surfaces of the second connector 74. The second overmolded portion may have a first end 60a and an opposing second end 60b. The first end 60a may engage or overmold the second connector 74 (e.g., second end 74b). The second end 60b may surround the horn 14 and / or the distal end 13. The second end 60b may include one or more protrusions / ribs 62 (e.g., longitudinal members, ridges, bulbs, etc.). The first end 60a may be overmolded over one or more ribs 75h. A through opening 64 may extend through the second overmolded portion 60. The through opening 64 may narrow away from the second connector 74 or from the first end 60a to the second end 60b.
[0067] In some embodiments, the feed barrel 20, base 50, base body 55, and / or device 10 may include various lengths for various applications of the surgical tip 14, having different lengths (e.g., one or more extensions). To adjust the length of the feed barrel to accommodate various surgical tip lengths, multiple base bodies 55 of various lengths may be manufactured and then selected for the application length (e.g., a first feed barrel length, a second feed barrel length that is longer than the first feed barrel length). For example, the base and / or base body may be extruded over a predetermined first length. The selected base body 55 having the predetermined first length is then overmolded and / or combined with an overmolded connector 70 and 40 / 60 (e.g., a combination of a connector and an overmolded portion). This may result in a first feed barrel length for one application. In another application, the selected base body may be a predetermined second length. The selected base body 55 having the predetermined second length is then overmolded and / or combined with an overmolded connector 70 and 40 / 60 (e.g., a combination connector and overmolded portion), which may result in a second carry length for another application, different from the first carry length.
[0068] It should be noted that the configuration using a silicone boot seal or first overmolded portion 40 against a standard or electrosurgical nose cone assists in the high voltage breakdown strength and sealing necessary to prevent conductive saline from transmitting electrical potentials to the surgeon or patient's anatomy. Similarly, the silicone surgical tip, i.e., second overmolded portion 60, assists in electrical safety and resistance to ultrasonic arcing and mechanical vibration. The distal silicone rubber or overmolded rubber helps to resist erosion and cracking due to, for example, arcing when RF is applied to the surgical tip for coagulation. Existing devices and prototypes of fully rigid fluid delivery barrels have failed abruptly in testing due to electrosurgical arcing without the benefit of silicone.
[0069] In some implementations, the ferrylet tip, i.e., second overmolded portion 60 (e.g., silicone), may have a high melting point for durability with ultrasonic energy and electrosurgical arcing. Additionally, the ferrylet tip may have a high insulation resistance to confine electrosurgical discharge to the working surface.
[0070] In some implementations, the fluid carry boot, i.e., first overmolded portion 40 (e.g., silicone), may have material conformality for a friction fit with existing equipment (e.g., nose cones). Additionally, the fluid carry boot may have high insulation resistance to confine electrosurgical discharge to the work surface.
[0071] In some implementations, the barrel body 22 or base body 55 (e.g., polycarbonate) may have reduced friction when inserted through a trocar, eliminating or reducing expansion and contraction of the barrel from barrel movement through the trocar (e.g., eliminating or reducing visual obscuration of the tip). Additionally, the extrusion length may be easily modified for laparoscopic tips of different lengths by adjusting the length of the base body. Additionally, the barrel body may have high insulation resistance to limit electrosurgical discharge to the working surface.
[0072] In some implementations, it may be advantageous to overmold one or more overmold sections (e.g., first, second) onto the connector 70 instead of onto the opposing ends of the elongated extruded tube or base body. The silicone cure temperature may approach or exceed the glass transition temperature of extrusion grade polycarbonate. Overmolding onto a separate insert pair / connector may allow the material to be selected for injection moldability, which may be more compatible with the preferred silicone cure temperature. This may also simplify tooling, since the total overmold tool size only needs to accommodate the insert itself, rather than the entire length of the extruded tube or base body, and also simplifies core pin blocking on the inner diameter. This may also result in a more modular design, avoiding the need for multiple sets of overmold tools to produce multiple lengths of feed barrels. Note that care in selecting materials and opacity allows for laser welding in some embodiments. The insert / connector, having a black polymer, heats up upon absorption of the laser energy, causing both heat and welding as it approaches the clear polymer (eg, the base body).
[0073] laparoscopic surgical tip As shown in Figures 4A-4I, the one or more laparoscopic surgical tips 14, if used, may have a first horn member 14a, a second horn member 14b, and one or more third horn members 14c joined with one or more threaded couplers 18. The adjacent ends of the horn members define a portion of the coupler 18 for connecting the horn members (e.g., 14a, 14b, 14c, etc.) to provide one or more predetermined lengths of the one or more tips 14. In some implementations, this modular construction allows for proper straightness and concentricity of the gun-drilled central lumen over a limited length while maintaining uniform and minimal stress in the distal tapered Gaussian region, in which material stresses are amplified to achieve substantial amplitude at the ends.
[0074] The joining / coupling of the first horn member 14a, the second horn member 14b, and the one or more third horn members 14c, if used, may be done with a pneumatic vice or collet rather than a standard flat to fasten with a wrench. This allows for one or more lengths of the horn 14 for use in an operating room that cannot be disassembled either accidentally or intentionally (e.g., in an unsanctioned attempt to modify the device). In some implementations, as shown in Figures 4D-4I, the horn 14 may include one or more third horn members 14c for one or more lengths or uses. Each third horn member 14c may be about 90 mm to about 120 mm in length. For example, this may be 100 mm, which is a half wavelength of a 23 kHz compression standing wave in titanium. The one or more third horn members 14c, if used, may be half wavelength expanders / members / modules. The one or more third horn members 14a may have a different inner and / or outer diameter than at least one of the first and second horn members in some embodiments. The speed of sound of 23 kHz in titanium results in a compressed wavelength (e.g., speed of sound divided by frequency) of approximately 214 mm, half of which is the practical length of the surgical extension, 107 mm. Thus, an extended length surgical tip with one or more third horn members can be long enough to cover the entire extent of the liver resection, even taking into account trocar placement. This was tested in design validation using acceptable to very acceptable geometries.
[0075] It has been discovered that in some implementations, one or more half-wave dilators, i.e., third horn members 14c, can be added and the Gaussian tapered section of the surgical tip adjusted to obtain a resonance and amplitude that is appropriate for surgery. Creating a modular system of tip sub-components may allow these three or more sub-components to create two different catalog articles by simply adding at least one third horn 14c to create an extended length tip. While useful for efficiency of scale, this design approach may allow transverse modes, which are very sensitive to diameter, to be suppressed specifically along the mid-section of the device at the extended length. Increasing the diameter moves the transverse modes up in frequency, while reducing the diameter moves these modes down. The dilator diameter has little effect on the longitudinal modes (e.g., 23 kHz design frequency), and therefore modifying the dilator diameter may be a useful design tool that does not allow competing deviation modes to be powered in the device operation. Since the second expander, ie, the third horn member, consists of a step up and a step down, the net effect on gain (eg, stroke) may be minimal.
[0076] It is noted that the existing CUSA Excel laparoscopic surgical tip has limited surgical tip amplitude and fragmentation power for robust tissues is the square of the amplitude. As laparoscopic surgery evolves, more and more diseased tissues are addressed, such as cirrhotic tissues or those affected by chemotherapy. A standard expandable laparoscopic surgical tip has a surgical tip amplitude of about 15% greater and a fragmentation power of about 30% greater. The scope of surgery can be extended to more robust tissues.
[0077] In some embodiments, the extendable laparoscopic tip can be doubled (e.g., two third horn members between the first and second horn members) and / or tripled (e.g., three third horn members between the first and second horn members) to allow for a very long surgical tip suitable for seamless integration with a robotic manipulator. A dual and / or triple extendable tip combined with the feed barrel 20 (e.g., a longer or extended feed barrel / base body with connector 70, molded portion 40 / 60, base body 55) can create a surgical tip and feed barrel system that is long enough to be connected with at least one robot during one or more applications. Implementation is not limited to dual or triple embodiments.
[0078] In some implementations, 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 surgical tip 14 (e.g., the first and second horn members) can be expanded in length L using a half-wave expander, i.e., the third horn member 14c, without substantially changing the basic design. The titanium horn 14 has a wavelength of the frequency of resonance divided by the acoustic velocity, and the half-wavelength is again half of the wavelength. For illustration, the third horn member 14c at this expanded diameter has a half-wavelength of about 107 mm. The expander, i.e., the third horn member 14c at this diameter of about 107 mm, can be added to the antinode via, for example, a threaded attachment / coupler 18. The threaded coupler may be positioned adjacent to the antinode. This causes the standing wave to expand through the node of stress maximum and then to another antinode. The resonant frequency and standing wave may not be affected as strongly with an expander, i.e., a third horn member. In some applications, a double or two third horn members and / or a triple or three horn members may be added and the surgical tip may be functional in resonance and ability to fragment tissue. Horn members 14a-14c, if used, may be "over-torqued" so that the surgical tip 14 may not be practically disassembled in the operating room. For example, one third horn as shown in Figures 4D-4F may be added and pneumatically fastened using special equipment.
[0079] In some implementations, one or more kits may be used for one or more applications. For example, a kit may have one or more barrels 20 of various lengths (e.g., a first length, a second length, a third length, etc.) and / or one or more horns 14 of various lengths (e.g., a first length, a second length, a third length, etc.).
[0080] While several inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications in which the teachings of the present invention are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Thus, it should be understood that the foregoing embodiments are presented by way of example only, and that within the scope of the appended claims and their equivalents, the inventive embodiments may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.
[0081] All definitions as defined and used herein should be understood to supersede any dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meaning of the defined terms.
[0082] As used herein, the indefinite articles "a" and "an," as used in the specification and the claims, should be understood to mean "at least one," unless expressly indicated otherwise.
[0083] As used herein, the term "and / or" as used in the specification and in the claims should be understood to mean "either or both" of the elements so joined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so joined. Other elements may optionally be present other than the elements specifically identified by the "and / or" clause, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with an open term such as "comprising," can, in one embodiment, refer to "A only" (optionally including elements other than B), in another embodiment, to "B only" (optionally including elements other than A), in yet another embodiment, to "both A and B" (optionally including other elements), etc.
[0084] As used herein in the 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" shall be construed as being inclusive, i.e., the inclusion of at least one, but also including more than one of a number of elements or a list of elements, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number of elements or a list of elements. In general, the term "or" as used herein when preceded by terms of exclusivity such as "either," "one of," "only one of," or "exactly one of," shall be construed as indicating only exclusive alternatives (i.e., "one or the other but not both"). "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.
[0085] As used herein in the specification and in the claims, the phrase "at least one" in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified. 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") can refer in one embodiment to at least one A, optionally including more than one A, in which B is absent (optionally including elements other than B), in another embodiment to at least one B, optionally including more than one B, in yet another embodiment to at least one A, optionally including more than one A, and at least one B, optionally including more than one B (optionally including other elements), etc.
[0086] Also, unless expressly indicated to the contrary, it is to be understood that in any method claimed herein that includes more than one step or act, the order of the method steps or acts is not necessarily limited to the order in which the method steps or acts are recited.
[0087] In the claims, and in the above specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., to mean "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 the United States Patent Office Manual of Patent Examining Procedures Section 2111.03.
[0088] The present invention may be embodied in other forms without departing from its scope and essential characteristics. The described embodiments are therefore to be considered in all respects as illustrative and not restrictive. Although the present invention has been described in terms of certain preferred embodiments, other embodiments which are apparent to those skilled in the art are also within the scope of the present invention.
Claims
1. A liquid delivery tube for use with an ultrasonic horn, A base having a first connector and a second connector interconnected by a base body, the base body including a first end and an opposing second end, the first end of the base body including the first connector and the second end of the base body including the second connector. Equipped with the first connector includes a first overmolded portion adapted to engage a nosecone; The second connector includes a second overmolded portion.
2. The fluid delivery tube of 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 a plastic weld, an adhesive bond, and an adhesive seal.
3. The fluid delivery barrel of claim 2 , wherein at least one of the first connector and the second connector is secured to the base body by the plastic weld and the adhesive bond.
4. The fluid delivery barrel of claim 3 , wherein at least one of the first connector and the second connector is secured to the base body by the adhesive seal.
5. 2. The fluid feed barrel of claim 1, wherein at least one of the first connector and the second connector includes one or more ribs, the one or more ribs being overmolded by the first overmolded portion and the second overmolded portion, respectively.
6. The sender of claim 1 , wherein at least one of the first connector and the first overmolded portion defines at least a portion of an irrigation port.
7. The fluid delivery barrel of claim 1 , wherein the second overmolded portion includes a through opening that narrows away from the second connector.
8. 1. An ultrasonic surgical device for fragmenting tissue and removing fragmented tissue, comprising: A surgical handpiece comprising a housing, a nose cone attached to the housing, a fluid delivery tube 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 irrigation fluid adjacent the surgical site to suspend fragmented tissue; an aspiration system connected to the handpiece for aspirating fluid and fragmented tissue at the surgical site; Equipped with the fluid supply barrel having a first end and an opposing second end, the fluid supply barrel including a base, a first overmolded portion defining the first end, and a second overmolded portion defining the second end.
9. 9. The device of claim 8, wherein the base includes a base body having a first end and an opposing second end, a first connector, and a second connector, the first connector being connected to the first end of the base body and the second connector being connected to the second end of the base body.
10. The apparatus of claim 9 , wherein the first connector comprises the first overmolded portion and the second connector comprises the second overmolded portion.
11. 11. The apparatus of claim 10, wherein at least one of the first connector and the second connector includes one or more ribs that engage the first and second overmolded portions, respectively.
12. 10. The device of claim 9, wherein at least one of the first connector and the second connector are secured to the first end and the second end of the base body, respectively, by at least one of a plastic weld, an adhesive bond, and an adhesive seal.
13. 13. The device of claim 12, wherein at least one of the first connector and the second connector are secured to the first end and the second end of the base body by the plastic weld and the adhesive bond, respectively.
14. 14. The device of claim 13, wherein at least one of the first connector and the second connector are secured to the first end and the second end, respectively, of the base body by the adhesive seal.
15. The apparatus of claim 9 , wherein the first connector and the second connector are made from a different material than the first overmolded portion and the second overmolded portion.
16. The apparatus of claim 9 , wherein the base body is made from a different material than the first and second overmolded portions.
17. 1. An ultrasonic horn, comprising: A first horn member; A second horn member; one or more third horn members connecting the first horn member to the second horn member along a predetermined length of the horn; An ultrasonic horn comprising:
18. 20. The ultrasonic horn of claim 17, wherein at least one of the third horn members is a half wavelength of about 90 mm to about 120 mm.
19. 20. The ultrasonic horn of claim 18, wherein at least one of the third horn members is approximately 107 mm half wavelength.
20. The ultrasonic horn of claim 17 , wherein the third horn member is positioned at an antinode.
21. 20. The ultrasonic horn of claim 17, further comprising a threaded coupling between the third horn member and a respective one of the first horn member and the second horn member.
Citation Information
Patent Citations
Ultrasonic aspirator
US4063557A
Ultrasonic aspirator
US4223676A
Ultrasonic resonant vibrator
US4425115A
Ultrasonic surgical system with aspiration tubulation connector
US4988334A
Apparatus for providing enhanced tissue fragmentation and / or hemostasis
US5015227A