Vibratory surgical instruments for liposuction and other body contouring applications

Abstract

A vibrating handheld surgical instrument for loosening tissue in a patient for liposuction or body contouring procedures has a motor coupled to a vibrating actuator with an eccentric rotating mass, and an end effector operatively coupled to the vibrating actuator for engaging tissue, the motor rotating the eccentric mass, which causes the end effector to vibrate and loosen the tissue. A flexible shaft with first and second ends damps vibrations relative to the motor and operator handle.

Description

[Technical field]

[0001] The present invention relates to a handheld vibrating instrument for liposuction and other body contouring surgical procedures.

[0002] REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 832,281, filed April 10, 2019, which is incorporated by reference in its entirety. [Background technology]

[0003] Liposuction is one of the most commonly performed surgical procedures. Liposuction is a procedure that slims and reshapes areas of the body to remove excess fat and improve the body's shape. Liposuction may be used for therapeutic reasons, such as to treat obesity, or for cosmetic reasons to improve appearance. Liposuction is also often performed to remove adipose tissue that can be reinjected as an autologous graft to flesh out areas of lost flesh after cancer resection, such as a woman's breasts. In this procedure, an incision is made, a cannula is inserted into the space previously occupied by the adipose tissue, and the surgeon's arm is advanced back and forth through the tissue to aspirate the fat through the cannula. This procedure can be quite inefficient as it requires a great deal of physical effort on the part of the surgeon, especially since the inner diameter of the cannula is limited to 2-5 mm to minimize the incision at the entrance site and thus the size of the resulting scar. This restriction restricts the entry site to only a few anatomical areas that can hide scarring, and then to tissue areas that are altered (loosened / broken apart) by the movement of the cannula. Another significant complication resulting from such liposuction procedures is the unsightly unevenness of the surface contour that can result if fat is extracted unevenly.

[0004] One existing technique reported to reduce surgeon fatigue and aid in the execution of the process uses a power-assisted liposuction device (PAL). An example of such a device is disclosed in U.S. Pat. No. 5,911,700. This device adds a 1-3 mm back and forth reciprocating motion of the cannula to the surgeon's motion at a 40-90 Hz frequency range, roughly the same as the frequency range of a jackhammer. Although this procedure is called vibratory liposuction, the device does not truly vibrate, but rather causes the cannula to reciprocate along the same linear (longitudinal) axis. Although the PAL technique reduces the surgeon's effort, the extraction is still performed through the same linear channel inscribed by the cannula, which essentially limits the area of ​​change caused by the device to the cannula diameter.

[0005] Another instrument designed to aid in liposuction is disclosed in U.S. Patent No. 9,457,177, which calls for imparting a nutation motion to the cannula that includes a combination of back and forth motion along with some vibration at the tip, depending on the cannula length. However, the mechanism involved in this instrument does not directly induce vibration, but rather uses sudden hammer-like blows of a piston moving back and forth within a channel to impart some vibratory effect to the cannula in addition to the alternating back and forth motion.

[0006] Another instrument designed to aid in liposuction (Vibrasat®, Moeller Medical) also imparts an arcuate pendulum-like motion to the cannula, presumably to loosen tissue and aid in more efficient extraction. It is considered by some to be an improvement over PAL, since in addition to extracting from the same scored tunnel as the reciprocating PAL, the sweeping motion extracts along an additional linear lateral path.

[0007] It is desirable to limit the size of incisions for liposuction for cosmetic reasons and to reduce tissue trauma and patient recovery time. However, with such small incisions, the above-mentioned instruments are limited in the extent of their tissue removal. Therefore, it would be advantageous to increase the extent of tissue removal without increasing the size of the incision.

[0008] Furthermore, the above mentioned devices often result in contour defects. It would be advantageous to provide a liposuction device that provides good reshaping and helps to avoid the complication of contour defects.

[0009] Low frequency vibrations applied to biological tissues can loosen these vascular structural frameworks with less risk of damage than sudden, powerful blows. Many household items (e.g., toothbrushes, shavers, etc.) and industrial devices (e.g., vibrating tables, funnels, tampers, etc.) use vibration to reduce friction and improve the flow, tamping, and / or spreading of particles, fluids, and / or air bubbles. Some medical devices use low frequency vibrations to prevent the development of osteoporosis, increase muscle mass, or facilitate the flow of mucus in the airways.

[0010] The vibration frequency ranges from ultra-low frequency (1 to 20 Hz), to sonic frequency (20 to 10 4 Hertz), ultrasonic range (10 4 ~10 9 Hertz), or hypersonic range (10 9 The frequency of the ultrasonic vibrations should be greater than 100 Hz. Many medical devices utilize ultrasonic vibrations for diagnostic or therapeutic applications. Some devices reported to facilitate liposuction utilize ultrasonic vibrations at high frequencies. These high frequencies may cause tissue trauma and may be detrimental for body contouring procedures.

[0011] When autografting is performed to fill a significant or precise morphological defect, such as micromastia, mastectomy, or tumor resection, it is not enough to fill this gap with graft tissue. Instead, the fibrous scar and any restrictive vascular framework of the tissue should also be loosened to accept the additional mass. Even if the recipient site is pretreated using external expansion means to the extent disclosed in, for example, U.S. Patent No. 8,066,691, and / or the device that can percutaneously expand the tissue to be expanded with a mesh, for example, disclosed in U.S. Design Patent Nos. 796,671 and 801,523 and U.S. Patent Publication No. 2015 / 0032143, the degree of expansion is still limited.

[0012] It would be beneficial to improve the space for the graft as well as improve the diffusion and flow of the non-Newtonian fluid to facilitate insertion and improve dispersion of the graft particles (lipoaspirate is a non-Newtonian fluid).

[0013] Vibrating handpieces are currently found among the newer items commonly used for personal massage (see, e.g., U.S. Patents Nos. 3,370,583 and 5,925,002). However, these handpieces are not designed to be coupled to surgical instruments and lack many of the features required for FDA approved surgical instruments, such as autoclaves, that are sterile and safe enough to be introduced into a patient's body. Furthermore, these handpieces are not designed to be coupled to liposuction cannulas and cannot be effectively used for liposuction or other body contouring surgical procedures.

[0014] Many small appliances use an eccentric rotating mass (ERM) to create the desired vibration. However, electric rotating engines, such as alarm buzzers and vibrators with ERMs directly coupled to small household appliances, are often limited in size and power. Large, powerful engines directly coupled to ERMs require extremely robust construction (extra strong bearings, fasteners, dampers, etc.) to protect them from the wear and tear damage caused by vibration. [Prior art documents] [Patent documents]

[0015] [Patent Document 1] U.S. Patent No. 5,911,700 [Patent Document 2] U.S. Pat. No. 9,457,177 [Patent Document 3] U.S. Pat. No. 8,066,691 [Patent Document 4] U.S. Design Patent No. 796,671 [Patent Document 5] U.S. Design Patent No. 801,523 [Patent Document 6] US Patent Application Publication No. 2015 / 0032143 [Patent Document 7] U.S. Pat. No. 3,370,583 [Patent Document 8] U.S. Patent No. 5,925,002 Summary of the Invention

[0016] The present invention solves the problems and shortcomings of the prior art. The present invention provides a vibration instrument that loosens or fragments tissue at an optimized speed and frequency, thereby effectively balancing between avoiding tissue trauma and negatively impacting tissue integrity while providing surgical efficacy. The instrument of the present invention also fragments / loosens tissue in areas larger than the cannula diameter without detrimentally increasing the size of the surgical incision used to access the body cavity. This is accomplished by the selected vibrational motion of the instrument together with the associated drive system and vibration damping system, while avoiding the disadvantages and shortcomings of electromechanical transducers or converters that use alternating currents and magnetic fields to produce reciprocating motion of the cannula, back and forth motion of the cannula, and not harmonic or pure vibration of the piston, lateral arcuate oscillation and back and forth motion, and both oscillation and distal oscillation during frontal impact.

[0017] According to one aspect of the present invention, there is provided a vibrating handheld surgical instrument for loosening tissue of a patient for liposuction or body contouring procedures, the instrument having a motor and a rotating flexible shaft having a first end and a second end. The first end is operatively connected to the shaft of the motor. A vibration actuator includes an eccentric rotating mass operatively connected to the second end of the rotating flexible shaft. A tissue-engaging end effector is operatively connected to the vibration actuator, and the motor rotates the eccentric mass, which causes the end effector to vibrate and loosen tissue.

[0018] In some embodiments, the end effector is permanently coupled to the vibration actuator, while in other embodiments, the end effector is removably attached to the vibration actuator.

[0019] In some embodiments, the end effector has at least one opening at a distal portion and has a lumen for one or both of injecting fluid into the patient's body and / or aspirating tissue from the patient's body.

[0020] In some embodiments, the end effector is aligned with the longitudinal axis of the rotating shaft, while in other embodiments, the end effector is offset from the longitudinal axis of the rotating shaft.

[0021] In some embodiments, the instrument has a damping mechanism extending between a housing for the motor and the vibration actuator for damping vibration of the end effector and coupling the motor to the vibration actuator, hi some embodiments, the damping mechanism can include a first spring mounted on the shaft and a second stationary spring mounted on the first spring.

[0022] In some embodiments, a first coupler is coupled at one end to a shaft of a motor and at the other end to a shaft about which the rotating eccentric mass rotates.

[0023] In some embodiments, the microcontroller is configured to selectively adjust at least one of the frequency of the vibration actuator or the amplitude of the harmonic or pure (true) vibration. In some embodiments, the microcontroller has a sensor and a servo control mechanism that receives information that enables the servo control mechanism to adjust the vibration of the instrument with the natural frequency of the treated tissue to reach or avoid resonance.

[0024] In some embodiments, the rotating eccentric mass imparts a purely oscillatory motion to the end effector, while in other embodiments, the rotating eccentric mass imparts a reciprocating motion to the end effector in conjunction with the oscillatory motion imparted to the end effector.

[0025] In accordance with another aspect of the present invention, a vibrating handheld surgical instrument for loosening a patient's tissue for liposuction or body contouring procedures is provided having a cannula with a lumen for one or both of injecting fluid into the patient's body or aspirating material from the patient, a motor and a vibration actuator operatively connected to the motor, the motor actuating the vibration actuator to impart a vibrating motion to the cannula such that vibrations occur in multiple axes.

[0026] In some embodiments, the motor further imparts a reciprocating motion to the cannula in conjunction with the oscillatory motion.

[0027] In some embodiments, the cannula is removably attached to the vibration actuator.

[0028] In some embodiments, the vibration actuator has a shaft and a rotating eccentric mass attached to the shaft, hi some embodiments, the cannula is offset from a longitudinal axis of the shaft.

[0029] In some embodiments, the motor is directly coupled to an eccentric rotating mass within the vibration actuator, and the damping component passes through a passive coil to protect the operator's hands.

[0030] In some embodiments, the additional reciprocating motion is produced by a separate solenoid mechanism that is coupled to or interacts with the vibrating component.

[0031] According to another aspect of the present invention, there is provided a method for performing liposuction or loosening soft tissue, the method comprising the steps of: a) providing a handheld instrument having a motor, a vibration actuator operatively connected to the motor, and a cannula operatively connected to the vibration actuator; and b) actuating the motor to cause rotation of the vibration actuator, thereby causing vibration of the cannula within the tissue, wherein an operator of the instrument is shielded from vibration by a damping mechanism connecting the motor to the vibration actuator.

[0032] In some embodiments, the method further comprises removing fat from the soft tissue by vibration through the cannula, hi some embodiments, the method further comprises injecting a fluid, therapeutic agent, or implant into the soft tissue during or after the vibration.

[0033] In some embodiments, the method further comprises the step of inserting a rod or tissue file to loosen the vascular framework of the treated tissue and induce an inflammatory response that can result in further tissue formation and remodeling.

[0034] In some embodiments, the method further comprises selectively adjusting at least one of a frequency or amplitude of the vibration.

[0035] In some embodiments, the gripping portion around the motor has a dampening cover including rubber, foam, ribs, or geometrically designed three-dimensional structures that can further reduce the transmission of vibrations to the surgeon's hand.

[0036] Those skilled in the art will readily understand how to configure and use the surgical device disclosed in this specification, so the following detailed description of preferred embodiments of the present invention will be provided with reference to the drawings. [Brief description of the drawings]

[0037] [Figure 1] FIG. 1 is a perspective view of one embodiment of a device of the present invention. [Diagram 2] FIG. 2 is a side view of the instrument of FIG. 1 with a drive mechanism housing and a portion of the vibration actuator housing removed to show the internal components. [Diagram 3] FIG. 2 is a side view of the instrument of FIG. 1 with a drive mechanism housing and a portion of the vibration actuator housing removed to show the internal components. [Figure 4]FIG. 2 is a close-up view of the internal components of the device of FIG. 1, showing the spring of the damping mechanism and the eccentric rotating mass of the vibration mechanism. [Diagram 5] FIG. 2 is a close-up view of the internal components of the device of FIG. 1 with the stationary spring omitted to show the flexible rotating shaft spring. [Figure 6A] FIG. 13 is an enlarged perspective view showing the connection of the end effector to the vibration actuator in accordance with an alternative embodiment of the present invention. [Figure 6B] 6B is an enlarged perspective view similar to FIG. 6A, showing an alternative embodiment of the coupling of the end effector and the vibration actuator; [Figure 6C] FIG. 6B is an enlarged perspective view similar to FIG. 6A, illustrating another alternative embodiment of a coupling for the end effector and vibration actuator. [Figure 7A] FIG. 13 is an enlarged perspective view of an alternative embodiment of a coupling for releasably connecting an end effector to a vibration actuator. [Figure 7B] FIG. 7B is a view similar to FIG. 7A showing the clamp in a closed (clamped) position for securing the end effector to the vibration actuator. [Figure 8A] FIG. 13 is an enlarged perspective view of an alternative embodiment of a coupling for releasable connection of an end effector to a vibration actuator, the coupling being shown in position for attachment or release of the end effector. [Figure 8B] FIG. 8B is a view similar to FIG. 8A showing the end effector attached (fixed) to the vibration actuator. [Figure 9A] FIG. 2 is an enlarged perspective view of a connector of the device of FIG. 1 for connecting the motor shaft and the eccentric rotating mass shaft. [Figure 9B] FIG. 9B is a view similar to FIG. 9A showing the attachment of a rotating shaft spring to a spring extension of a connector. [Figure 10] FIG. 2 is an enlarged view of the eccentric rotating mass and roller bearing of the device of FIG. 1. [Figure 11A]FIG. 13 is an enlarged side view of an alternative embodiment in which the eccentric rotating mass of the instrument provides the oscillating and reciprocating motion, the eccentric rotating mass shown in a position with the sleeve and cannula in a rearward (proximal) position. [Figure 11B] FIG. 11B is a view similar to FIG. 11A showing the eccentric rotating mass rotated to a second position with the sleeve and cannula in a forward (distal) position. [Figure 12A] FIG. 11B is a view similar to FIG. 11A, showing an alternative embodiment having ball bearings to reduce friction in the reciprocating motion of the outer sleeve. [Figure 12B] FIG. 12B is a view similar to FIG. 12A, showing the rotating mass rotated to a second position with the sleeve and cannula in a forward position. [Figure 13A] FIG. 13 is a side view of an alternative embodiment of the instrument of the present invention having an offset end effector. [Figure 13B] FIG. 13 is a side view of another alternate embodiment of the instrument of the present invention having an offset end effector. [Figure 14A] FIG. 13 is a side view of an alternative embodiment of the present invention having an offset end effector in an instrument that imparts vibration and reciprocating motion, showing the eccentric mass in a position with the cannula in a forward (distal) position. [Figure 14B] FIG. 14B is a view similar to FIG. 14A, but showing the rotating mass rotated to a second position with the sleeve and cannula in a rearward (proximal) position. [Figure 15A] FIG. 13 is a side view of an alternative embodiment of the instrument of the present invention having an offset end effector and gear mechanism, the instrument providing oscillating and reciprocating motion, with the cannula shown in a distal position. [Figure 15B] FIG. 15B is a view similar to FIG. 15A, but showing the cannula in a proximal position. [Figure 16A] FIG. 13 is a side view of an alternative embodiment of an instrument of the present invention having an offset end effector and a magnet to move the end effector, the instrument providing an oscillating and reciprocating motion, and the cannula shown in a distal position. [Figure 16B] FIG. 16B is a view similar to FIG. 16A, but showing the cannula in a proximal position. [Figure 17] FIG. 2 is a side view of an alternative embodiment of an instrument of the present invention having an offset end effector and a solenoid mechanism for moving the end effector, the instrument providing oscillating and reciprocating motion, with the cannula shown in a proximal position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The present invention provides vibration instruments (instruments) for performing surgical procedures such as liposuction, autografting, and other body contouring applications. The instruments of the present invention generally include a handpiece / housing containing a motor that produces vibrations, a vibration mechanism / vibration actuator that produces the vibrations, a damping mechanism between the motor and the vibration mechanism that dampens the vibrations, and an end effector attached to the vibration mechanism that engages the patient's body tissue. When the motor is activated, it causes the motor shaft to rotate a shaft that supports the vibration mechanism, which rotates and produces vibrations in the end effector, e.g., a cannula, to loosen or break apart the tissue. Various embodiments of these instruments and their mechanisms / components are described in detail below. It should be noted that the terms "instrument" and "instrument" are used interchangeably herein.

[0039] In a preferred embodiment, the end effector is in the form of a cannula through which tissue is aspirated and / or fluid is injected, also as described in more detail below.

[0040] Various couplings for securing the end effector to the vibration actuator are described herein. In some embodiments, the end effector is permanently attached to the vibration actuator, and in alternative embodiments, the end effector is removably attached to the vibration actuator. These various couplings are described in more detail below.

[0041] In some embodiments, the end effector, e.g., a cannula, is aligned with the longitudinal axis of the instrument. In alternative embodiments, the end effector is offset from the longitudinal axis, thus shortening the overall length of the instrument in some configurations. These various embodiments are described in detail below.

[0042] The present invention provides a handheld instrument that delivers true harmonic vibrations to an end effector, e.g., a cannula, similar to the tip of a tuning fork. In doing so, the cannula tip covers a much larger circular surface area than a cannula, and therefore potentially extracts fat from a larger area. This allows the surgeon to extract from a larger area, even with a small diameter cannula introduced through a small, hidden puncture wound entry site. In other words, a larger tissue extraction area can be provided while using the same size incision. Furthermore, the harmless entry site allows the surgeon to use multiple sites, if desired, which can aspirate a particular anatomical area evenly and effectively through the crisscross path. At the same time, the effect of the technical concept of the present invention by covering a very large footprint area is similar to catching a fish with a wide net compared to a spear. Furthermore, the vibration loosens the fibrous scaffold of the tissue, so that it can be better reshaped and helps to avoid the occurrence of complications of surface contour defects.

[0043] In a preferred embodiment, the device operates at 10 Hz to 10 Hz for liposuction and additional reconstructive surgical procedures. 3It uses true mechanical vibrations at low frequencies in the Hertz range. In one embodiment, for example, a harmonic vibration handpiece can deliver this therapeutic vibration by one or more routes and at one or more intensity levels. Other ranges are also envisioned.

[0044] Low frequency mechanical vibration is advantageous for liposuction procedures, which effectively loosen fat for removal by suction through a liposuction cannula.

[0045] For autografting to fill significant morphological defects of substantial size or precision, such as micromastia, mastectomy, or tumor resection, the present invention can loosen the restrictive vascular structural framework of tissue to accommodate additional mass. Increasing the size improves the procedure, since filling the defect with graft tissue is insufficient. This increase is achieved by the low frequency mechanical vibration of the instruments disclosed herein, which effectively loosens the structural framework so that it can expand and create space for the graft. In addition, the vibration improves the dispersion and flow of non-Newtonian fluids, which eases insertion and improves the dispersion of graft particles (aspirated lipoprotein is a non-Newtonian fluid).

[0046] The aspirated adipose tissue fluid obtained by liposuction contains many types of cells in addition to fat cells or adipocytes. When aspirated adipose tissue is used in fat grafting, the active components responsible for tissue augmentation are believed to be stromal vascular fraction (SVF) or adipose derived stem cells (ADSC) that become new fat, while the majority of re-implanted fat cells are believed to die without revascularization. The vibration of the tissue during extraction by the inventive device loosens these small undifferentiated cells, which are typically associated with capillaries, and thus, as a result, most of these active components of fat grafting are collected. This is similar to shaking the tree properly to get the apples.

[0047] Moreover, these low frequency mechanical vibrations of the instruments disclosed herein loosen the structural framework while resulting in less damage to the vascular network than percutaneous cutting and meshing techniques. In some embodiments, pure harmonic vibrations without back and forth jack hammering end strikes of the instruments utilizing, for example, PALs and pistons, can result in less trauma to the tissue while still allowing the tissue to be plastically, deformably and moldably moldable. Thus, in preferred embodiments, the surgical instruments deliver truly low frequency mechanical vibrations. Pure or truly oscillatory motion as defined herein means vibration in multiple axes. The multiple axes are perpendicular or transverse to the longitudinal axis of the cannula. In reciprocating (back and forth) motion, the instrument moves along the longitudinal axis. In rocking motion, the vibration is in one axis like a pendulum. In the pure oscillatory motion of the present invention, the vibration is like a tuning fork or a piano string, which vibrates along its length. Pure vibration occurs upon actuation, not as a result of impact as in reciprocating motion, where some vibration may occur when the tip impacts tissue.

[0048] Additionally, in some embodiments, the system allows for control of vibration amplitude or frequency, which the physician can adjust to resonate with the transducer instrument, e.g., the cannula, and the treated tissue. Similarly, depending on tissue elasticity and toughness, some embodiments can provide a similar level of control over the frequency, amplitude, and intensity of the vibration.

[0049] In some embodiments, the pure harmonic vibrations of the devices disclosed herein may be delivered externally through a shield such as a transducer applied to the skin in order to loosen and promote the diffusion of injected fluids and suspended particles. Additionally or alternatively, the vibrations may be delivered internally to deep sites or multiple planes by inserting a solid rod-like or file-like ablation probe to loosen the internal structural fibrous framework.

[0050] In some embodiments, the vibrating instrument may further include a liposuction cannula (as an end effector), whereby the vibrations can facilitate loosening of fat lobules from fibrous attachment and entrapment by the cannula. Similarly, the vibrations of the cannula used in the implantation procedure can help to disperse the graft and loosen restrictive structures to open space for and accommodate the graft without excessive trauma. In yet other embodiments, the vibrating member can act as a tissue file or rasp to create controlled inflammation and wounding, resulting in scarring fibrosis and contraction of the tissue envelope and helping to lift, rejuvenate, and remodel various tissues, such as sagging or misshapen breasts. The above are some examples of surgical applications, as use in other surgical procedures is also envisioned.

[0051] Experimental Example 1: A scientific evaluation of the extraction efficiency and quality of liposuctioned fat obtained with a vibrator handpiece coupled to a liposuction cannula according to one embodiment of the present invention (FIG. 1). This instrument was compared to a PAL (power-assisted liposuction instrument) and liposuction was performed on both sides of the same patient. In this example, a harmonic vibration handpiece instrument was used on one side and a PAL on the other side. Approximately the same liposuction vacuum source and extraction cannula were used for both instruments, the amount of fat extracted over a 12-minute period of liposuction was recorded, and sample tissue was sent to the laboratory for stem cell analysis. Liposuction with the harmonic vibration handpiece was at least 30-45% more efficient than PAL liposuction in terms of the amount of fat extracted per minute of liposuction. Furthermore, SVF and ADSC were also approximately 30-45% more abundant per milliliter of liposuctioned fat in samples obtained with the harmonic vibration handpiece than with the PAL.

[0052] This example demonstrates that vibrations produced according to embodiments of the present invention loosen soft tissue and also induce greater release of mesenchymal stem cell content. It also demonstrates that the vibrating cannula tip according to embodiments of the present invention has a wider removal zone than a cannula that pistons back and forth in the same channel, resulting in greater efficiency and removal of more fat per stroke and per minute. Furthermore, in long-term evaluation, harmonic liposuction with the pure vibration device of the present invention results in better surface contour and more even tissue re-coverage and shrinkage than PAL liposuction.

[0053] It has been found that different frequencies and amplitudes also provide different effects that can benefit different applications and requirements. For example, larger amplitudes are more effective in fat removal, but using larger amplitudes with higher frequencies can cause too much trauma to sensitive tissues and may be detrimental to the integrity of the recipient vascular scaffold required for successful engraftment. The frequencies of the present invention achieve this optimal balance of efficiency and reduced trauma.

[0054] Moreover, higher frequencies can selectively extract more adipose-derived stem cells, regardless of amplitude.Thus, some embodiments are dynamic in adjusting and synchronizing the frequency and corresponding amplitude according to specific clinical requirements.

[0055] Referring now to the drawings and to specific embodiments of the invention, several embodiments of the handheld surgical instrument (instrument) of the present invention are shown, with like reference numerals indicating substantially identical structural features of the instrument disclosed herein. Initially, referring to FIGS. 1-3, a handheld instrument according to one embodiment of the present invention is shown and designated by the reference numeral 10. The instrument 10 has a) a drive mechanism, also referred to as a drive system or engine system, including a drive component; b) a vibration mechanism, also referred to as a vibration actuator, including a vibration component to produce a vibration motion; c) a damping mechanism, also referred to as a damping / connector system, including a damping component to dampen the vibrations and provide a connector mechanism to couple the engine to the vibration actuator; d) an end effector, e.g., a cannula, that engages the tissue of a patient and is operatively coupled to the vibration actuator; and e) a clamp / coupling / component that operatively couples the end effector to the vibration actuator. Each of the systems / mechanisms / components is described in detail below. As used herein, the phrases "coupled" or "operably coupled" refer to either a direct coupling or an indirect coupling of components, where the components are interposed between the two components but the two components are nevertheless joined / coupled to one another such that they interact with one another.

[0056] In use, actuation of motor 18 rotates flexible shaft 34 to rotate eccentric rotating mass 42, which in turn vibrates cannula 52 to loosen tissue. During the procedure, tissue may be aspirated through the lumen of cannula 52 and through one or more openings in the distal region of the cannula that communicate with the lumen. Instrument 10 (as well as other instruments disclosed herein) may be used for liposuction, autograft procedures, body contouring procedures, or other surgical procedures where it is beneficial to loosen or break tissue apart and restructure their shape through the vibratory motion of the instrument.

[0057] Turning first to the drive, the system (engine component) has a motor 18 housed within a drive system housing 16. The drive system housing 16 also serves as a "handpiece" that the surgeon holds during the surgical procedure, thus providing a handheld instrument. The motor may be an electric motor, or alternatively, a pneumatic rotary motor with an engine that converts hydraulic pressure into rotary motion. In the embodiment of Figures 1-3, the motor shown is, by way of example, a brushless motor. The engine component further includes a power source housed within the housing 16, such as a battery (which in some embodiments may be sterilizable) or alternatively, a plug that may be connected to an external power source. In the embodiment of Figures 1-3, a cable 24 connects to an external power source / controller. The engine component may further include various gauges, sensors, control mechanisms, and switches for the motor.

[0058] In addition to or as an alternative to a battery, an electric engine may use a power controller located within the handpiece that includes electrical wiring to deliver power and feedback circuitry to a transformer or control module. In such an embodiment, the power regulator may be located outside the surgical field. Such an embodiment allows for a display of vibration frequency (e.g., correlated to engine rpm).

[0059] The drive system (motor) in some embodiments may be activated through the use of a foot switch for the surgeon to operate. Additionally or alternatively, a manual control on the handpiece may activate the drive system.

[0060] The handpiece is ergonomically designed to fit comfortably in the surgeon's hand and may be covered with dampening rubber with ribs or cushions to reduce the transmission of vibrations to the surgeon's hand during use.

[0061] Continuing to refer to the embodiment of Figures 1-3, a manual control 20 accessible to the clinician is positioned on the housing 16. The control 20 may be in the form of a lever, button, or the like operable by the surgeon to actuate the motor to rotate the motor shaft to produce vibrations as described below. A motor plate 22 located adjacent the distal region of the motor 18 secures the motor 18 within the housing 16 and protects the motor against the forces required to pass the end effector through tissue. A cable 24, which may have a pin connection as shown, extends proximally through an opening in the housing 16 to connect the motor 18 to an external power source or controller (not shown).

[0062] As used herein, the term "proximal" refers to the part / area / component that is closer to the user and the term "distal" refers to the part / area / component that is further from the user during use.

[0063] Additionally, it should be noted that the term "about" as used herein means ± (plus or minus) 15% of the numerical value provided.

[0064] A cylindrical housing 40 is positioned distally of and spaced axially slightly distally from the drive system housing 16. In the illustrated embodiment, the housing 40 has the same outer diameter as the cylindrical housing 16, although the housing may have a larger or smaller diameter. The cylindrical housing houses a vibration actuator. Specifically, within the vibration housing 40 is positioned a motorized eccentric rotating mass (ERM) 42 which mechanically generates a pure vibration effect (e.g., harmonic vibration) without a piston moving back and forth and without a more complex piezoelectric electromechanical transducer that uses alternating current to create an oscillating motion. The vibration amplitude of such an arrangement is a function of the mass and its eccentricity, while the vibration frequency is the driven harmonic vibration of the cannula when the system is forced to vibrate at the excitation frequency or rpm speed of the rotary engine.

[0065] An eccentric mass 42 is connected to the drive shaft 46 and is in the form of a half-disk rotatable within a cavity (channel) 41 (see Figures 4 and 10) and has ears 43 (Figure 10) that fit into grooves in the housing 40 that keep the eccentric rotating mass 42 centered within the channel. Rotation of the eccentric mass 42 creates a purely oscillatory motion that is transmitted to the end effector. The position and eccentricity of the mass are adjustable to vary the amplitude of the vibration.

[0066] The eccentric rotating mass 42 produces vibrations. The axis of the mass 42 may be held securely between specially designed, heavy duty roller bearings 48 on the distal and proximal sides of the rotating mass 42 and configured to withstand lateral stresses, axial loads, and vibrations.

[0067] The spring rotating shaft 34 (described in more detail below) is under slight tension to protect the ears 43 by keeping them against the raceways of the bearings 48. The spring rotating shaft 34 is connected to the rotating mass 42 via a connector as described below.

[0068] In some embodiments, the weight of the eccentric rotating mass 42 is about 10 grams to about 25 grams, the distance from the axis of rotation to the center of mass is about 5 mm to about 25 mm, and the outer diameter is about 2 cm to about 6 cm. It should be noted that these values ​​are given by way of example, as other weights, distances and diameters (outside of these ranges) are also contemplated so long as they achieve the functions and advantages of the eccentric rotating mass 42 of the present invention. The mass 42 is sized so that the vibrations do not exceed a size that is too broad to be practical for surgical procedures. On the other hand, the mass is sized sufficiently to loosen or break apart a sufficiently wide area of ​​tissue with an end effector, e.g., a cannula. It should be noted that the above dimensions have been found to strike an optimal balance between powerful vibrations that are found to be potentially dampening on the one hand, and vibrations that are too weak to have minimal therapeutic effect.

[0069] However, the vibrator must be of sufficient size and power. The large and powerful vibration forces that can be used in some embodiments of the present invention may use strong engine torque to rotate a large mass with a significant eccentricity. However, directly coupling a powerful engine that is small enough to be handheld to a large eccentric rotating mass may cause excessive wear and tear and premature fatigue failure of the electric engine component parts. Furthermore, it is advantageous to shield the operator's hands from these powerful vibrations, and wrapping the instrument in a damping material, while useful, may not be sufficient. Another factor to take into account is the significant back and forth forces required to advance the cannula through tissue.

[0070] Shielding the engine from these compression and expansion forces extends the life of the equipment, and to that effect, some embodiments of the present invention have damping connectors to shield the rotating engine and the operator's hands from the strong vibrations of the eccentric rotating mass.

[0071] The damping system / component may include a medical grade stainless steel flexible rotating shaft connected at one end to the engine (motor) shaft and at the other end to the shaft 46 of an eccentric rotating mass 42 mounted within the vibration actuator housing 40. The flexible rotating shaft is preferably spring-like and slightly tensioned. While the flexible rotating shaft transmits the rotational coupling action from the engine, a stationary but flexible stationary connector shaft is provided to surround the rotating shaft and counteract the rotation to prevent the remainder of the instrument from rotating at high speeds. In the instrument 10, the stationary connector shaft is in the form of a spring. Alternatively, rather than a single spring design, the stationary connector may be comprised of multiple springs or bumpers arranged in an array around the rotating shaft so that they provide counter-rotational protection, maintain lateral flexibility, and damp vibrations. For example, the static connection means may include a spring or a flexible hollow structure, such as a rubber hose, that surrounds the rotating shaft and provides a damped link between the handpiece and vibration actuator components. This damped connector component can preserve the life of the engine while protecting the surgeon's hands from excessive vibration.

[0072] An additional rubber connector may be provided surrounding the rotating shaft and stationary connector, which acts as a protective sealing component. An insulator component shields the patient from accidental electrical transmission. The insulating means may be located at multiple heights / locations, but is preferably located at the clamp / connection component or at the effector component.

[0073] The damping connector may include a flexible rotating shaft for transmitting rotational motion to the eccentric rotating mass of the instrument, with a flexible stationary connector wrapped around the shaft to mechanically couple the engine / handpiece component to the eccentric rotating mass. This configuration isolates the engine / handpiece component of the instrument from vibrations of the eccentric rotating mass. Additionally, for protection from the compressive and tensile forces of liposuction, the flexible rotating shaft transmitting rotational motion is preferably pre-tensioned to a certain degree compared to the stiffer flexible stationary connector, which is not connected to the motor.

[0074] 4 and 5, the damping mechanism (also referred to as a damping connector system or component) of the instrument 10 of FIG. 1 is shown in detail to provide an example of the damping mechanism described above including rotary and stationary connectors. The damping system includes a rotary shaft spring 34 that couples the shaft of the motor 18 to the shaft 46 of the eccentric rotary mass 42. The spring 34 transfers the rotary coupling to the engine where rotation of the motor shaft causes rotation of the eccentric mass shaft. A large spring 32 is fitted radially spaced from and provides a stationary connector to oppose the rotation. The spring is slightly under tension to keep the ears 43 of the eccentric rotary mass 42 against the raceways of the bearings 48 as described above. The spring constant of the stationary spring 32 is preferably between about 50 lbs / in (8.92 kg / cm) and 350 lbs / in (62.42 kg / cm). It has been found that approximately 30 pounds of force is necessary to prevent the vibration head (housing 40) from hitting the handpiece (housing 16); less force will cause the vibration head to hit, and more force will not provide sufficient damping. Therefore, the spring force of the instrument 10 is designed to achieve an optimum balance.

[0075] A rubber foam 36 (FIG. 3) and / or viscoelastic element can be fitted to the spring and molded as a sleeve around the spring and / or used as a mating coupling between the spring and the instrument housing. This increases the effective spring constant, thereby providing additional damping and acting as a seal. As shown in FIG. 3, a rubber foam connector 36 covers the shaft and seals the connection between the handpiece and the vibration actuator.

[0076] The rotary shaft spring 34 is flexible and crushable and tensioned to insulate the engine from drive loads. The spring 34 is extended from about 2 mm to about 10 mm when the instrument is in the rest position. Less extension may cause the spring shaft to buckle as the vibration head and handpiece touch each other, while more extension may cause too much load on the motor and bearings and may cause the spring 34 to buckle. Its spring constant is about 2 lbs / in (0.36 kg / cm) ± (plus or minus) 0.5 lbs / in (0.09 kg / cm). A higher spring constant may cause damaging loads on the motor and bearings, and a lower spring constant may cause the shaft to break.

[0077] The rotating shaft spring 34 is connected at its opposite ends to connectors 37 as shown in Figures 5, 9A and 9B. The proximal connector (coupling element) 37 has a threaded hole 37a to receive a set screw 37b for fixing the proximal connector 37 to lock the proximal connector 37 into the motor shaft 19, and the distal connector (coupling element) 37 has a threaded hole 37a to receive a set screw 37d for fixing the proximal connector 37 to lock the distal connector 37 to the eccentric rotating mass shaft 46. The distal connector 37 has a proximally extending shaft extension 39 that fits into the inner circumference at the first end of the spring shaft 34. A groove 37e in the connector 37 locks the tail of the coil spring. The distal connector 37 is shown in Figure 9B with the spring 34 fitted into the connector extension 39. An extension of the proximal connector 37 extends distally to fit within the inner circumference of the spring shaft 34 at the second end of the shaft 34 .

[0078] A clamp and / or coupling mechanism is provided to couple the end effector to the vibration actuator. The end effector may be, for example, a liposuction cannula bent like a hockey stick, a similarly shaped fat grafting cannula, an infusion cannula, a rod, which may be either smooth or rough to act as a tissue file, flattened disk, etc. The cannula may alternatively be L-shaped or T-shaped. Additionally, the cannula may be single or multiple, for example, a dual lumen cannula. The dual lumen may, for example, allow for fluid injection and fluid aspiration through separate lumens so that such fluid injection and fluid aspiration can occur either separately or simultaneously.

[0079] In the embodiment of FIG. 1, the end effector 52 is in the form of a cannula having one or more side openings 56 (FIG. 3) at a distal region and / or a distal opening at the end of the lumen for communicating with a lumen extending within the end effector. The cannula 52 is operatively coupled (attached) to a vibration actuator so that vibrations are transmitted to the cannula 52 for loosening tissue during liposuction, body contouring, or other surgical procedures. The cannula 52 is in the shape of a hockey stick with an angled connector 58 that includes a luer fitting 58a (or other form of fitting) that can be connected to aspiration / infusion source tubing for aspirating or injecting saline, lipoaspirate, medication, or other fluids, for example, for swelling the tissue, through the lumen and into the body tissue through the opening 56 of the cannula 52. It is noted that other shapes of cannula are also envisioned.

[0080] Various clamping and / or coupling mechanisms for securing the end effector 52 to the vibration actuator components are now described. In some embodiments, the end effector is permanently attached to the vibration actuator, for example, in the embodiment of FIG. 1, while in other embodiments, the end effector is removably / releasably attached to the vibration actuator. Removable attachments allow different sizes or styles of end effectors to be used with the same handpiece. The coupling mechanism can couple the end effector, for example, a shield-like external skin vibrator, a rod-like internal vibrator, a file-like internal rasp, a cannula for fluid injection, liposuction or fat injection, etc. The end effector shown is a catheter for suction / fluid injection to perform procedures such as liposuction, grafting, and body contouring procedures, but it should be understood that other end effectors can be used with the various embodiments of the instruments disclosed herein.

[0081] In FIG. 1, the cannula may be permanently attached by a connector clamp member 50 provided within housing 40 which applies a clamping force to the cannula at the area adjacent the bend, or alternatively, the cannula may be removably / replaceably connected to housing 40 by a bolt / nut screw mechanism, as shown in FIG. 8, for example, as described below.

[0082] 6A-8B show alternative embodiments of connectors for releasably attaching the end effector to the vibration actuator. However, it should be understood that these mechanisms can also be used for permanent attachment of the end effector. It should also be understood that other mechanisms can be used to releasably or permanently attach the end effector to the vibration actuator.

[0083] Referring initially to the embodiment of FIG. 6A, a screw 25 extends distally from a vibration housing 40a for the vibration actuator and is inserted into a proximal opening 49a in a head or cap 49 of an end effector 52a. The head 49 may be constructed of plastic. This threaded engagement removably attaches the end effector 52a to the vibration actuator. It should be noted that the cannula 52a with the angled luer connector 58a is identical to the cannula 52 of the embodiment of FIG. 1. Moreover, with the exception of the attachment mechanism, the components of the instrument of FIG. 6A are identical to those of the embodiment of FIG. 1, and therefore, to avoid clutter, no further description is necessary, as the features and functions of the instrument 10 are directly applicable to the embodiment of FIG. 6A, the difference being the removable threaded connection.

[0084] It should be noted that although the cannula is shown as being hockey shaped, as discussed above, in the embodiments of Figures 1 and 6A-8B (as well as other embodiments disclosed herein), the cannula may alternatively be L-shaped or T-shaped, and may be a single or multi-lumen cannula.

[0085] If the cannula is constructed of metal, it may have a plastic casing over it to provide electrical insulation.

[0086] In the alternative embodiment of Figure 6B, a polygonal fitting 27 extends distally from the housing 40b for the vibration actuator and is inserted into a correspondingly sized proximal opening 61 in the head or cap 49b of the end effector 52b. A screw 63 passes through an opening in the cap 49b across the longitudinal axis of the instrument and through an opening 27a in the fitting 27 to secure the two components (cap 49b and housing 40b). Note that the cannula 52b has an angled Luer connector 58b similar to the cannula 52 of the embodiment of Figure 1. In FIG. 6C, a pin lock secures the end effector cap 49c to the vibration housing 40c as it passes through an opening 28a in the polygonal fitting 28, which extends distally from the vibration housing 40c and is insertable into a correspondingly sized opening 64 in the cap 49c of the end effector 52c. Note that the fittings 27, 28 may be shaped differently than shown. Note that the cannula 52c has an angled luer connector 58c similar to the cannula 52 of the embodiment of FIG. 1. Furthermore, with the exception of the attachment mechanism, the components of the instrument of FIGS. 6B and 6C are identical to those of FIG. 1 and therefore, to avoid clutter, further description is not necessary as the features and functions of the instrument 10 are directly applicable to the embodiment of FIGS. 6B and 6C.

[0087] In the alternative embodiment of Figures 7A-8B, a clamping mechanism removably / releasably secures the cannula to the vibration actuator. It is noted that in Figures 6A-6C, the end effector is attached by a cap or housing that is coupled to the vibration actuator, whereas in the embodiment of Figures 7A-8B, the cannula itself (without the cap) is attached to the vibration housing.

[0088] Referring initially to the embodiment of Figures 7A and 7B, cannula 84 has an angled luer connector 86 similar to cannula 52 of Figure 1. A plastic sleeve 87 is fitted over some portions / regions of the cannula to provide electrical insulation. Sleeve 87 may cover some or all of the length of cannula 84.

[0089] The proximal end of the cannula 84 is inserted into a nipple or pointed tip 82 of the housing 40d for the vibration actuator. The connector is shown in FIG. 7A in an unclamped position. In this position, the nipple 82 provides sufficient clearance so that an end effector can be removably received therein. An angled portion 86 passes through the clearance provided in the housing 40d as shown. The clamp lever 80 is in an open unclamped position. Once inserted, when it is desired to secure the cannula 84 in the nipple 82, the lever 80 is moved (rotated) from the position of FIG. 7A to the clamped position of FIG. 7B. This causes the housing to close the clearance G and the space in the nipple 82 to clamp (grasp) the cannula 84. The locked cam thereby holds the end effector securely in place. When it is desired to release the cannula 84, the clamp lever 80 is returned to the position of Figure 7A to open the gap / spacing so that the cannula 84 can slide out of the gap in the nipple 82 and housing 40d. It should be noted that the clamping force may be applied to the insulating sleeve 87 as shown in Figure 7A, or in an alternative embodiment, directly to the cannula 84.

[0090] The embodiment of Figures 8A and 8B is similar to the embodiment of Figures 7A and 7B, except that instead of a clamping lever to clamp the plastic sleeve of the cannula, a screw is used to couple the vibration actuator to an end effector, e.g., a cannula, by tightening it to hold the cannula firmly in place. The screw 90 is inserted into the opening 91 and tightened. This closes the gap H, so that the housing 40e and nipple 92 can clamp (grasp) the cannula 94. A plastic sleeve 98 fitted over a portion of the cannula 94 or over the angled luer connector 96 provides electrical insulation. The housing 40e clamps the insulating sleeve 98 as shown, but in an alternative embodiment, the cannula 94 may be clamped directly.

[0091] It should be noted that the plastic sleeve 87 (or 98) locked by the clamping mechanism can have the same exterior design and caliber regardless of the caliber of the end effector utilized.

[0092] In the above embodiment, the end effector, e.g., a cannula, is aligned coaxially and along the longitudinal axis of the instrument. However, the end effector may be offset from the longitudinal axis in alternative embodiments. This offset may be within the confines (diameter) of the handheld instrument, or alternatively, may be outside the confines of the handheld instrument as shown in Figures 13A and 13B.

[0093] In the embodiment of Figures 13A and 13B, a coupling component or coupling housing 140 is attached to a vibration actuator housing 142 (which contains an eccentric rotating mass 145 identical to the rotating mass 42 and the roller bearings described above). The coupling component 140 is offset from the housing 142 so that the channel for receiving the end effector, e.g., a cannula 144, is radially spaced from the longitudinal axis of the rotating shaft of the eccentric mass 145 and the motor shaft (not shown). In this way, the cannula 144 is radially offset from the longitudinal axis of the instrument. In Figure 13B, the instrument has an additional component 146 for rounding the exposed edges of the vibration actuator housing 142. The cannula 144 can be permanently or removably coupled to the housing 142. Removability is provided by permanently attaching housing 140 to housing 142 but removably attaching the cannula through a channel provided in housing 140, or alternatively, by removably attaching housing 140 to housing 142 with the cannula either removably or permanently secured within housing 140. A variety of connection schemes can be utilized to attach housing 140 and housing 142, such as clips, screws, and the like, as well as attachment means such as fittings utilized in Figures 6A-6C.

[0094] Offsetting the cannula 144 (in this and other offset cannula embodiments) and locating it along the side of the vibration actuator housing 142 advantageously reduces the overall length of the instrument. That is, in embodiments where the cannula is aligned with the longitudinal axis, the proximal end of the cannula extends from the distal edge of the vibration actuator housing, and in offset embodiments, a region 144a of the cannula 144 is located proximal to the distal edge, thereby reducing the overall length of the instrument by the length of region 144a. The damping mechanisms, vibration motion, etc. of the instrument of Figures 13A and 13B are otherwise identical to that of instrument 10, and therefore the features, components and functions of instrument 10, such as eccentric rotating masses, bearings, damping mechanisms, motors, etc., can be utilized in the instrument of Figures 13A and 13B.

[0095] Vibration and reciprocation

[0096] In the above embodiments, the end effector moves in a purely oscillatory motion via a rotating eccentric mass. In alternative embodiments, a reciprocating motion to the end effector is provided in conjunction with the oscillatory motion. This helps to reduce the force that needs to be exerted by the surgeon as he or she pushes through tissue during a surgical procedure. Thus, in these embodiments, the vibration actuator produces a back and forth reciprocating motion in addition to harmonic or pure (true) vibration.

[0097] Such motion can be achieved in some embodiments by the inclusion of an additional piston / cylinder component that can slide back and forth on the vibration actuator component and couple to the clamp / connector component. The back and forth oscillation of this reciprocating part can be actuated by a rod and cam mechanism, which in some embodiments can be circular, disk-like or oval-shaped, while its motion is constrained by the piston / cylinder arrangement and balanced by a spring.

[0098] An example of a rod and cam mechanism is shown in Figures 11A and 11B. The rotating eccentric mass 102 is in the shape of an asymmetrical disk with one portion (region) 104 having a reduced width (transverse dimension) compared to the opposite end portion (region) 106, resulting in a narrower portion. Extending inwardly from the outer sleeve 122 is a rod 124 having a surface or edge 126 which engages the camming surface 106a of the wider region 106. The outer cylinder (sleeve) 122 may have a restoring spring 132 to keep the bearing 110 in contact with the cam weight.

[0099] In the initial deflection-back (proximal) position of FIG. 11A, surface 104a of narrow portion 104 is contiguous with or slightly spaced from edge 126 of rod 124, but exerts zero or minimal distal force on rod 124. As eccentric rotating mass 102 rotates within cavity 108 of vibration actuator housing 120, camming surface 106a of wide portion 106 exerts a force on surface 126 or rod 124, moving rod 124 and attached sleeve 122 in a distal direction (see arrows in FIG. 11B). When eccentric rotating mass 102 is rotated back to the position of FIG. 11A, narrow portion 104 is adjacent rod 126, thus removing the force on rod 126. This allows sleeve 122 to return to its proximal position. As can be seen, as the eccentric rotating mass 102 rotates, the sleeve 122 reciprocates (moves back and forth) in conjunction with the oscillatory motion imparted to the sleeve by the rotating eccentric mass 102, thereby imparting an oscillatory and reciprocating motion to an end effector, e.g., a cannula, attached to the connector 136 via the opening 138. Thus, in this embodiment, the eccentric rotating mass 102, which creates a vibration similar to the half-disk of FIG. 1, also acts as a cam to reciprocate the end effector. In other words, the disk-like eccentric cam 102 also functions as an eccentric rotating mass to create an oscillation in the end effector.

[0100] It should be noted that the device of Figures 11A and 11B is otherwise identical to device 10 of Figure 1, including, for example, bearing 110 (similar to bearing 48), a damping mechanism with rotating shaft spring 128 (similar to rotating shaft spring 34), a large diameter spring 130 in the stationary connecting shaft (similar to stationary spring 32), a motor, etc.

[0101] The sleeve 122 has ball bearings 134 to reduce friction during piston / cylinder reciprocation and to extend the life of the instrument, as shown in the alternative embodiment of Figures 12A and 12B. Otherwise, the embodiment of Figures 12A and 12B is identical to the embodiment of Figures 11A and 11B and is provided with the same reference numerals.

[0102] It should be noted that the sleeve with the rod may be the outer sleeve as shown, or alternatively may be positioned within the outer sleeve.

[0103] 14A and 14B show an alternative embodiment with an offset end effector within the instrument to provide the vibration and reciprocating motion.

[0104] The instrument of Figures 14A and 14B has a rotating eccentric mass 150 similar to the rotating eccentric mass 140 of Figure 11A because it provides the oscillating and reciprocating motion to the end effector. A linking component or housing 152, shown diagrammatically, is attached to a vibration actuator housing 154, which contains the eccentric rotating mass 140. Various methods of mounting the housing 152 are envisioned. For example, a rod 164 connected to the housing 154 may piston in and out while constrained within a channel in the housing 154. To further reduce friction, the channel may have roller bearings. An additional railing mechanism parallel to the rod piston may further absorb forces driving the end effector into tissue and aid in alignment. The connecting component 152 is offset from the vibration actuator housing 154 such that a channel in the component 152 that is sized to receive the cannula 155 is radially spaced from the longitudinal axis of the vibration actuator shaft 157 and the motor shaft (not shown). The cannula 155 is thus radially offset from the longitudinal axis of the instrument. A region 155a of the cannula 155 is located proximal to the distal end of the housing 154, thereby reducing its overall length.

[0105] When the disk-shaped rotating mass 150 is rotated from the position of FIG. 14B where the narrow region 160 is adjacent or contiguous with the rod 164, the end effector (e.g., cannula) 155 moves from the proximal position to the distal position of FIG. 14A as the wide region 162 exerts a distal force on the rod 164. When the eccentric mass 150 is rotated back to the position of FIG. 14B, the end effector 155 can return to the proximal position. It is noted that the rod 164 is constrained by the spring 157 in a channel in the vibration actuator housing 154. As with the embodiment of FIG. 11A, the eccentric rotating mass acts as a cam to impart a reciprocating motion to the end effector in addition to providing an oscillatory motion.

[0106] It should be noted that the degree of deflection (distal movement) is determined by the shape of the cam component, e.g., height or width, so that the cam dimensions may differ from those shown to increase or decrease the range of distal movement. A seal surrounding this arrangement may be provided to maintain some lubrication.

[0107] 15A-17 show a modified mechanism for producing reciprocating motion of the end effector. The instrument may include the motor, damping mechanism, bearings, etc. of the instrument 10 of FIG. 1. In the embodiment of FIGS. 15A and 15B, a gear mechanism 170 held by roller bearings 172 produces some de-multiplication and changes the axis of rotation by 90°, resulting in vertical cam rotation. This is because rotating shaft 171 of vibration actuator (eccentric mass) 174 about its axis rotates gear 170a of gear mechanism 170, which in turn rotates gear 170b. This gear mechanism 170 rotates a semicircular eccentric rotating mass 174 in vibration actuator housing 173, which rotates an egg-shaped cam 178 (see arrow 178), which causes rod 179 to reciprocate according to the cam's eccentricity. Thus, cam 178 becomes a second miniature eccentric cam, which allows rod 179 to move in and out. Such reciprocating movement of rod 179 reciprocates end effector 179', which is offset from the longitudinal axis of the device by connecting component 175 (as in the embodiment of FIG. 14A). Spring 180 and cylindrical channel 182 maintain stability and alignment of end effector 179' and its clamping / connecting mass 175. Rotation of eccentric rotating mass 174 imparts the oscillatory motion associated therewith as described above, while rotation of cam 174b imparts reciprocating motion through gear mechanism 170 via rod 179. FIG. 15A shows end effector 179' in a forward (distal) position, and FIG. 15B shows end effector in an inward (proximal) position.

[0108] In the modified embodiment of Figures 16A and 16B, a magnetic system creates a reciprocating motion. Specifically, the rotating eccentric mass 186 is also a magnet with a north pole N on one half circle and a south pole S on the other half circle. A piston-like magnet 192 constrained in a cylinder 193 also has a north pole and a south pole. When the north pole side of the rotating mass crosses the north pole side of the piston-like magnet 192, it creates a repulsive force on the piston, thereby pushing the piston outward (distal) as shown in Figure 16A. When the eccentric mass 186 rotates another half rotation, the south pole crosses the north pole of the piston 192 and attracts the piston inward (proximal), which causes the end effector 194 to return inward (proximal) as shown in Figure 16B. It should be noted that the end effector 194 is offset in the same manner as the end effector of Figure 14A. The rotating eccentric mass 186 imparts both oscillatory and reciprocating motion to the end effector as it rotates.

[0109] In the alternative embodiment of Figure 17, an electrically driven solenoid 200 is coupled to a vibration actuator 202 to move an end effector 204 back and forth (reciprocating). Thus, the electromagnet solenoid mechanism provides reciprocating motion when the semicircular eccentric rotating mass 206 is rotating while providing oscillatory motion when it is rotating. Although the use of a solenoid adds complexity to the separate electrical setup that controls the solenoid, it results in fewer moving parts and less stress on existing moving parts. The solenoid also protects the flexible rotating shaft from additional torque loads.

[0110] In alternative embodiments with vibration only or vibration plus reciprocating motion, the motor may be directly coupled to the eccentric rotating mass, and in some embodiments is positioned in a housing for the vibration actuator, for example in housing 40 of FIG. 4. In such embodiments, the motor may vibrate. The vibration of the motor may be damped by its clamping mechanism. Allowing the motor to vibrate may cause more wear and tear on the engine and shorten its life, but resources may be reduced by eliminating the flexible rotating shaft. The damping component in such embodiments may include a coil, for example a rubber bumper sleeve that shields the coil shaft 32 of FIG. 4 or the part of the handpiece that the surgeon grips from vibration. In some of the embodiments where the motor is directly coupled to the eccentric rotating mass, a rotating shaft spring is not required, and a passive spring (coil) is provided to dampen the vibration and protect the operator's hands.

[0111] The rotating mass may be designed with an adjustable eccentricity to adjust the rocking force. Furthermore, a power control unit (microcontroller) may generate different vibration frequencies and different vibration amplitudes to provide different effects, both biological and mechanical. When the vibration frequency resonates with the internal frequency of the cannula, this may result in a harmonic vibration pattern that significantly increases the amplitude of vibration and significantly increases the extraction surface area compared to instruments that achieve extraction in one dimension. Thus, the instrument of the present invention may be considered a three-dimensional extraction device. Some of the advantages include: i) efficiency of harvesting millimeters / minute / stroke; ii) selective harvesting of the interstitial vascular fraction; iii) efficiency in loosening and atraumatically repositioning / reorienting / reorganizing the extracellular vascular scaffolding, imparting shape to the soft tissues by either contracting them, expanding them or making them more flexible and able to mold them, thus helping to remodel the tissue; iv) achievement of other effects such as local inflammation, induction of fibrogenic collagen synthesis, blood flow (both short and long term circulatory effects), capillary and nerve fiber destruction, etc.

[0112] In some embodiments, the electronic control component includes a microcontroller that controls the operation of the engine component. In some embodiments, the microcontroller sends electronic control signals to the engine component to start, stop, and regulate the speed and / or power of the engine component. In some embodiments, the handheld component includes a user interface in communication with the microcontroller. The user interface may include an input mechanism, such as a touch screen, buttons, switches, keyboard, or combinations thereof, for an operator to control the operation of the surgical handpiece. In some embodiments, the user interface displays current vibration parameters, such as motor frequency, amplitude, power, speed, duration, and / or other parameters, to the operator. The user interface may display a selection of these parameters to be used in the current vibration procedure. The user interface may also display a selection of these parameters that have been used in one or more previous vibration procedures.

[0113] In some embodiments, the mechanical vibration is applied continuously over a period of time. In some embodiments, the mechanical vibration is applied intermittently over a period of time. In some embodiments, the frequency, amplitude, and duration of the mechanical vibration delivered by the surgical handpiece can be adjusted manually by an operator or automatically according to a pre-programmed procedure stored in a non-transient memory of the electronic control component.

[0114] While the apparatus and method of the present invention have been described in terms of preferred embodiments, it will be readily apparent to those skilled in the art that changes and modifications can be made to these embodiments without departing from the spirit and scope of the invention, as defined by the appended claims.

Claims

1. 1. A vibrating handheld surgical instrument for loosening tissue of a patient for a liposuction or body contouring procedure, the vibrating handheld surgical instrument comprising: a housing and an end effector extending distally from the housing; a motor having a rotating shaft; a rotatable flexible shaft having a first end and a second end, the first end operatively coupled to the rotatable shaft of the motor; a vibration actuator including an eccentric rotating mass operatively connected to a second end of the rotatable flexible shaft; The end effector is a tissue engaging end effector extending distally from the housing containing the eccentric rotating mass operatively connected to a second end of the rotating flexible shaft to engage tissue, and the motor rotates the eccentric rotating mass, thereby causing the end effector to vibrate and loosen tissue.

2. The vibrating handheld surgical instrument of claim 1 , wherein the end effector is removably attached to the vibrating actuator.

3. 3. The vibrating handheld surgical instrument of claim 1 or 2, wherein the end effector has a distal portion and a cannula with a lumen for one or both of injecting fluid into the patient's body and aspirating tissue from the patient.

4. The vibrating handheld surgical instrument of any one of claims 1 to 3, wherein the end effector is aligned with a longitudinal axis of the rotating shaft.

5. The vibrating handheld surgical instrument of any one of claims 1 to 4, wherein the end effector is offset from a longitudinal axis of the rotating shaft and from the rotating shaft of the eccentric rotating mass.

6. A vibrating handheld surgical instrument according to any one of claims 1 to 5, wherein the vibration actuator is contained within the housing, and the end effector is offset from the housing in which the vibration actuator is contained.

7. 7. The vibrating handheld surgical instrument of claim 1, wherein the motor is contained within a housing, and the vibrating handheld surgical instrument further comprises a damping mechanism extending between the housing in which the motor is contained and the vibration actuator to damp vibrations of the end effector and to couple the motor to the vibration actuator.

8. A vibrating handheld surgical instrument as described in claim 7, wherein the rotating flexible shaft includes a first spring positioned within the vibration actuator and a second stationary spring fitted to the first spring.

9. 9. A vibrating handheld surgical instrument according to any one of claims 1 to 8, further comprising a first coupler having one end connected to the rotating shaft of the motor and the other end connected to the rotating flexible shaft, and a second coupler having one end connected to the rotating flexible shaft and the other end connected to a shaft about which the eccentric rotating mass rotates.

10. 10. The vibrating handheld surgical instrument of claim 1, further comprising a microcontroller configured to selectively adjust at least one of the frequency or amplitude of harmonic vibration of the vibration actuator.

11. A vibrating handheld surgical instrument according to any one of claims 1 to 10, wherein the eccentric rotating mass, when rotated, imparts a reciprocating motion to the end effector in association with a vibrating motion imparted to the end effector.

12. The vibrating handheld surgical instrument of claim 11 , wherein the eccentric rotating mass has a camming surface on one end to effect reciprocating movement of the end effector.

13. 13. The vibrating handheld surgical instrument of claim 1, further comprising a solenoid for effecting reciprocating movement of the end effector.

14. 14. The vibrating handheld surgical instrument of claim 1, wherein the end effector has a cannula, and the motor actuates the vibration actuator to impart an oscillatory motion to the cannula such that the vibration occurs in multiple axes.

15. The vibrating handheld surgical instrument of claim 14 , wherein the cannula loosens tissue within a surface area greater than the cannula.

16. The surgical instrument of claim 13 , wherein the solenoid is coupled to the vibration actuator.

17. A vibrating handheld surgical instrument according to any one of claims 1 to 6, further comprising a damping mechanism for protecting a user's hand, said damping mechanism including a passive coil.

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