Ultrasonic surgical blades

[0001] The present disclosure relates generally to ultrasound surgical blades used in ultrasound devices. Currently, ultrasonic devices are used in open and minimally invasive surgical procedures, including endoscopic and laparoscopic procedures, in which a part of the end effector of the ultrasonic device passes through the trocar to reach the surgical site. Partially due to the growing popularity of minimally invasive surgeries, ultrasound devices are increasingly used for the safe and effective treatment of many ailments. Operation of ultrasonic transducer devices in this context is well known in the art and will not be described again in this document for the sake of brevity. In short, an ultrasonic transducer induced by an electric generator generates mechanical vibrations in the ultrasonic frequency range that are transmitted longitudinally by the transmission component or waveguide to the end effector. Mechanical vibrations induce a longitudinal, transversal or twisting vibratory movement in relation to the end effector relative to the transmission component. The vibratory motion of the end effector generates local heat within the adjacent tissue, facilitating both cutting and coagulation of the tissue at the same time. Therefore, ultrasonic vibrations during transfer to organic tissue at appropriate energy levels using the appropriate end effector, can be used for cutting, cutting, separating, lifting, lifting,

[0002] It is generally accepted that ultrasonic devices, in particular ultrasonic devices comprising contact ultrasound elements, provide some advantages over other surgical instruments. Among these benefits is that ultrasonic mechanical vibrations can cause cutting and coagulation of tissue at the same time using relatively lower temperatures than traditional surgical instruments for cutting and cauterizing. The nature of ultrasonic devices allows for many applications, and a number of end effectors can be designed to perform numerous functions.

[0003] Ultrasonic instruments can be divided into devices with a one-piece end effector and devices with a multi-element end effector. Devices with a one-piece end effector include instruments such as blades, scalpels, hooks and / or ball coagulators. Although in general such end effectors are formed from materials are suitable for wave propagation, there are also end effectors with a hollow core to provide a fluid stream or suction channel. The multi-element end effectors include a solid, ultrasonic, one-piece end effector - blade - operably connected to a clamping mechanism to press or tighten the tissue between the blade and the clamping mechanism. Multi-element end effectors include clamping scalpels, clamping coagulators or any combination of clamping mechanism and one-piece end effector. Clamping end effectors are particularly useful when a significant amount of pressure is required to effectively transfer ultrasound energy from the blade to the tissue. The clamping end effectors apply a compression or deflection force to the tissue to promote faster cutting and coagulation of the tissue, in particular the loose and unsupported tissue.

[0004] Having regard to the state of the art described, it should be noted that surgical sites where ultrasonic instruments are used may be particularly difficult due to mechanical vibration forces applied to the end effector, resulting in thermal phenomena, as well as general conditions related to critical conditions occurring at the surgical site. For example, during use, the end effector comes into contact with surgical material that includes coagulants, proteins, tissue particles, and other component fluids. Over time, the surgical material tends to dry and adhere to the outer surface of the end effector. This build-up of the surgical material reduces the efficiency of the end effector by reducing the possibility of cutting by the end effector and / or tissue coagulation and increasing the impedance at the interface surface of the end effector / tissue. In order to compensate for the rise in impedance of the contact surface, the generator delivers more and more energy to the end effector to continue cutting the tissue until the energy supplied by the generator exceeds the predefined threshold value when the generator turns off or goes into "lock" mode. A blockage is a condition in which the impedance of the end effector is so high that the generator is unable to provide significant amounts of energy to the tissue. Block generator is an unwanted effect that occurs when the generator is unable to adequately power the end effector to terminate the cutting in the condition of increased impedance of the contact surface. The end of the cutting is signaled to the user by visually separating the tissue from the end effector of the device. When the generator goes into blockage, the surgical procedure is interrupted. Therefore, the blockage of the generator results in increased cutting and cutting times or, worse, downtime during surgery.

[0005] US 2006/100652 A1 discloses an ultrasonic surgical blade of the claimed type. It comprises a body having a proximal ending, a distal end, and an outer surface. The further end may move relative to the longitudinal axis according to the ultrasonic vibrations applied to the proximal end. The blade can be coated.

[0006] Accordingly, there is a need for an end effector with a suitable coating or a suitable combination of coating and surface treatment for the purpose of coating the protection of a surgical effector against the difficult conditions of the treatment. W or a proper combination of coating and surface treatment prevents or minimizes the build up of surgical material on the outer surface of the end effector, minimizes generator blocking, minimizes energy consumption, favorably affects the wear of the pads in the clamping type end effectors, and also improves the thermal performance of the end effector. It is also required to apply one or more suitable coatings to the outside surface of the end effector,

SUMMARY OF THE INVENTION [0007] The present invention relates to an ultrasound surgical blade. The ultrasonic surgical blade includes a body having a proximal end, a distal end, and an outer surface. The further end may move relative to the longitudinal axis according to the ultrasonic vibrations applied to the proximal end. At least a part of the outer surface of the body comprises a sliding coating adhering thereto. The sliding coating has a coefficient of friction which is less than the friction coefficient of the outer surface of the body, and furthermore the slip coating comprises a polymeric material.

[0008] Furthermore, the present invention relates to a method for producing an ultrasound surgical blade. Preferred embodiments are set forth in the dependent claims.

DRAWINGS [0009] Embodiments which form part of the invention are shown in Figs. 1, 2, 9, 10, 13 and 14. The embodiments shown in the remaining figures do not form part of the invention, but mean state of the art which is useful for understanding invention.

[0010] Innovative features of various embodiments are set forth in detail in the appended claims. However, various embodiments, both in terms of organization and modes of operation, can best be understood with reference to the description below in connection with the accompanying drawings.

Fig. 1 shows an embodiment of a multi-component end effector.

Fig. 2 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 1, taken along line 2-2.

Fig. 3 shows one example of a multi-element end effector.

Fig. 4 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 3, taken along line 4-4.

Fig. 4A is an enlarged view of a cross-sectional portion of one example of a part of the ultrasound blade of the multi-component end effector shown in Fig. 3.

Fig. 4B is an enlarged view of a cross-sectional part of one example of a part of the ultrasound blade of the multi-component end effector shown in Fig. 3.

Fig. 4C shows an enlarged view of a cross-sectional part of one example of a part of the ultrasound blade of the multi-component end effector shown in Fig. 3.

Fig. 5 shows one example of a multi-element end effector.

Fig. 6 shows a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 5, taken along line 6-6.

Fig. 7 shows one example of a multi-element end effector.

Fig. 8 is a view of the ultrasonic tip of the final illustrated line 8-8.

cross-section of the part of the multi-element effector in Fig. 7 made longitudinally

Fig. 9 shows one embodiment of a multi-component end effector.

Fig. 10 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 9, taken along line 10-10.

Fig. 11 shows one example of a multi-component end effector.

Fig. 12 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 11, taken along line 12-12.

Fig. 13 shows one embodiment of a one-piece end effector.

Fig. 14 is a cross-sectional view of a portion of the ultrasound blade of the one-piece end effector shown in Fig. 13, taken along line 14-14.

Fig. 15 shows one example of a multi-component end effector.

Fig. 16 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 15, taken along line 16-16.

Fig. 17 shows one example of a multi-element end effector.

Fig. 18 is a cross-sectional view of a portion of the ultrasound blade of the multi-component end effector shown in Fig. 17, taken along line 18-18.

DESCRIPTION [0011] Before explaining the various embodiments and examples in detail, it should be noted that the embodiments are not limited in their application or use to the construction details and configurations of the elements shown in the attached drawings and description. Surgical instruments and end effector configurations disclosed herein are exemplary only, and are not intended to limit the scope of the appended claims or application. Exemplary embodiments may be implemented or included in other embodiments, variations and modifications, and may be practiced or made in various ways. In addition, unless otherwise stated,

[0012] Various embodiments generally relate to end effectors for use in ultrasound surgical instruments. The ultrasound surgical instrument generally comprises an ultrasound transducer, an ultrasound-activated end effector, and a substantially unified or hollow ultrasonic waveguide that connects the ultrasound transducer with the end effector. The ultrasonic transducer is located in the processing handle. The end effector can be formed of a base material (e.g. a body) that is suitable for effectively transmitting or propagating acoustic waves in the ultrasonic frequency range. Thus, the end effector is an ultrasonic transfer element that can be coupled to an ultrasonic transducer directly or by means of an ultrasonic transmission waveguide. Examples of ultrasonic surgical instruments are disclosed in U.S. Patent Nos. 5,322,055 and 5,954,736, and combinations of ultrasonic end effectors (e.g., blades) and surgical instruments are disclosed in U.S. Patent Nos. 6,309,400 B2, 6,278,218 B1, 6,283,981 B1, and 6,325,811 B1. These reference sources provide an adequate general description of ultrasonic devices and end effectors. Therefore, the specific operation of such ultrasonic devices will not be discussed in detail herein. and combinations of ultrasonic end effectors (e.g., blades) and surgical instruments are disclosed in U.S. Patent Nos. 6,309,400 B2, 6,278,218 B1, 6,283,981 B1 and 6,325,811 B1. These reference sources provide an adequate general description of ultrasonic devices and end effectors. Therefore, the specific operation of such ultrasonic devices will not be discussed in detail herein. and combinations of ultrasonic end effectors (e.g., blades) and surgical instruments are disclosed in U.S. Patent Nos. 6,309,400 B2, 6,278,218 B1, 6,283,981 B1 and 6,325,811 B1. These reference sources provide an adequate general description of ultrasonic devices and end effectors. Therefore, the specific operation of such ultrasonic devices will not be discussed in detail herein.

[0013] More specifically, embodiments refer to ultrasonic end effectors comprising one or more coatings formed as layers of materials, surface treatment and / or any combination of the above. A suitable coating formed on the outer surface of the ultrasonic end effector provides a slip effect and is therefore useful for minimizing adherence of the surgical material to the outer surface of the end effector. The slip coating also reduces the friction between the end effector and tissue and thus minimizes the impedance of the interface between the end effector and tissue, and reduces the build up of heat in the end effector. This results in less energy consumption from the ultrasonic generator and causes the end effector to have a cooler heat profile, which minimizes the occurrence of the generator blockade and improves the overall stability of the surgical instrument. One skilled in the art will expect that a reduction in average energy consumption (again due to the reduced impedance of the contact surface) could result in a corresponding increase in the time required to perform surgical procedures such as cutting and coagulation of the tissue band. However, such a compromise regarding the cutting time was not found in the tests and in fact an unexpected reduction in cutting times was obtained. A further investigation revealed two reasons for unexpected results that have not been described in the prior art: (1) a lower coefficient of friction coatings (most coatings present in this document have low frictional components, as for example polytetrafluoroethylene, known as TEFLON® and referred to herein as PTFE), causes them not to adhere to the tissue and thus the tissue is released from the blade (indication of complete cut) more uniformly and faster than a comparable uncoated blade and (2) lower coefficient of friction and thus the impedance of the contact surface results in lower average energy consumption, and thus less frequent cases of generator blockage. In some embodiments, the cutting time has been reduced by about 34% due to the first mentioned cause. In some embodiments, fragments of thick, hard tissue (e.g., broad-womb ligaments) have been dissected in subsequent applications using a coated end effector blade, whereas a comparable uncoated device was unable (within a reasonable time) to perform the same task due to the second mentioned cause. In use, in various embodiments, the end effector blades comprising one or more coatings, as described herein, can improve the quality of tissue effects, such as hemostasis, by providing more even tissue dissection and / or coagulation.

[0014] As described herein, the coating may comprise one or more layers of materials formed on the surface of the outer part of the end effector ultrasound body.

The outer surface of the end effector can be partially or completely coated with one or more layers of material. Each layer may contain one or more materials. In other embodiments, it is possible to use one or more surface treatments with respect to the entire end effector body or parts thereof. In further embodiments, the end effector body can still include a combination of coatings and surface treatment applications. Such a combination can be applied to the entire end effector or its part.

[0015] In some embodiments, the materials, surface treatment and / or combinations of the above may be suitably applied to the outer surface of the end effector or portions thereof to produce a end effector having a coefficient of friction that is less than the base material of the end effector itself. End effectors with a lower coefficient of friction operate at lower temperatures and minimize generator blockage, supporting faster tissue cutting. In other embodiments, the surface treatment may be suitably implemented on the exterior surface of the end effector or portions thereof to produce a end effector having a coefficient of friction that is greater than the base material of the end effector itself. The end effectors with a higher coefficient of friction improve the effects of sealing the tissue together using the end effector. Thus, in some embodiments, it may be desirable to provide an end effector with a lower coefficient of friction in the cutting area and a higher coefficient of friction in the region of sealed tissue joining by using different combinations of coatings and surface treatments for different parts of the end effector.

[0016] Certain embodiments will now be described to provide a complete understanding of the principles of construction, functionality, manufacture, and the methods disclosed herein. One or more examples of these embodiments are shown in the attached drawings. Those skilled in the art will be aware that the devices and methods described in detail herein and in the accompanying drawings are non-limiting embodiments and that the scope of the various embodiments is determined solely by the claims.

[0017] It should be noted that the terms "proximal" and "distal" are used herein to refer to a physician holding the handle assembly of an ultrasound surgical instrument. As a result, the end effector is distal to the proximal part of the handle assembly. Furthermore, it should be noted that for convenience and clarity, spatial terms such as "top" and "bottom" are also used herein in reference to surgery that holds the handle assembly. However, surgical instruments are used in many directions and positions, and these terms are not limiting or absolute.

[0018] Fig. 1 shows one embodiment of a multi-element end effector 100. In the illustrated embodiment, a multi-component end effector 100 includes a clamp arm assembly 102, shown in an open position, operably coupled to an ultrasonic surgical blade 112 (blade). Multi-element end effector

100 can be used, for example, in a traditional coagulation ultrasonic device. The clamping arm assembly 102 includes a clamp arm 104 and a tissue washer 106 attached to the clamp arm 104. The blade 112 is an ultrasound transfer element suitable for engaging conventional ultrasonic surgical instruments. The blade 112 comprises a body 108, having a proximal end and a distal end, defining a longitudinal area of ​​action between them. The body 108 defines a longitudinal axis A extending between the proximal end and the distal end. The proximal end is adapted and configured for coupling to an ultrasonic transducer directly or via an ultrasonic transmission waveguide in a known manner. The mechanical vibration generated by the ultrasonic transducer propagates along the transmission waveguide and is coupled to the proximal end of the body 108. The distal end of the body 108 is selected such that it can move relative to the longitudinal axis A by mechanical vibration generated by the ultrasonic transducer. The distal end and the longitudinal area of ​​action are used to affect the tissue (e.g., cutting, cutting, cutting, coagulation). These tissue effects may be enhanced by clamping the tissue between the clamping arm 104 and the blade that it can move relative to the longitudinal axis A by mechanical vibrations generated by the ultrasonic transducer. The distal end and the longitudinal area of ​​action are used to affect the tissue (e.g., cutting, cutting, cutting, coagulation). These tissue effects may be enhanced by clamping the tissue between the clamping arm 104 and the blade that it can move relative to the longitudinal axis A by mechanical vibrations generated by the ultrasonic transducer. The distal end and the longitudinal area of ​​action are used to affect the tissue (e.g., cutting, cutting, cutting, coagulation). These tissue effects may be enhanced by clamping the tissue between the clamping arm 104 and the blade

112.

[0019] In one embodiment, the sheath 116 may be molded or applied to at least a portion of the outer surface of the body 108 that at least corresponds to the elongated machining area. Coating 116 may include one or more layers 110 formed on the outer surface of body 108. Each of the one or more layers 110 may consist of one or more materials. Accordingly, in one embodiment, layer 110 may actually comprise several sublayers. In one embodiment, the coating 116 may consist of a base layer (e.g. a primer layer, a first layer) and a cover layer (e.g., a top layer, a second layer) and one or more layers 110 therebetween.

[0020] Fig. 2 is a cross-sectional view of a part of the ultrasound surgical blade 112 of multi-element end effector 100 made along line 2-2 in Fig. 1. As can be seen in the cross-sectional view of Fig. 2 of the embodiment shown, the body 108 generally has a circular cross-section. In other embodiments, the body 108 may have any suitable cross section and may be inherently symmetrical or asymmetrical. For example, the body 108 may have a cross-sectional shape defined by a triangle, a square, a rectangle, a pentagon, a hexagon, any suitable polygon, or an irregular, symmetrical or asymmetrical shape. The body 108 may be made of a base material suitable for transmitting ultrasound energy in the form of acoustic waves.

[0021] In one embodiment, the sheath 116 may be formed as one layer 110 on at least a portion of the outer surface of the blade body 108. The layer 110 may consist of at least one material, and in other embodiments it may comprise a plurality of layers including a base material (e.g. a primer layer, a first layer) and a covering material (e.g., a top layer, a second layer) as described in detail herein with reference to Figures 3 and 4. The thickness of the layer 110 can be any, ranging from about 0.0001 to about 0.010 inches (0.00254 mm to 0.254 mm). Coating 116 may partially or completely cover the outer surface of body 108. Layer 110 may be molded over the entire body 108 or may be molded on portions of body 108. The coating material 116 can be selected to have a lower coefficient of friction than the material of the body 108. [0022] The layer 110 comprises a plurality of materials including polymers and polymer-containing materials. The term "polymeric materials" and the word polymer, as used herein, include, but are not limited to, homopolymers, copolymers, terpolymers, and the like. Non-limiting examples of polymeric or polymeric materials include tetrafluoroethylene (TFE) and copolymers (FEP) hexafluoroprop (yl) enu (HFP), liquid FEP, FEP / ceramic composites, FEP liquid epoxy epoxy composites, polytetrafluoroethylene (PTFE or TEFLON®), and PTFE / ceramic composites. In other non-limiting embodiments, layer 110 may include dry lubricant, such as tungsten disulfide, molybdenum disulfide, among others, graphite as well as fluorinated polymers. In further non-limiting embodiments, layer 110 may include ceramics, e.g. metal oxides, metal nitrides, and also metal carbides, among others. Examples of ceramics include, but are not limited to, chromium carbide, tungsten carbide, titanium nitride, aluminum oxide, and also chromium nitride. In other non-limiting embodiments, layer 110 may include metals. Metals include, among others, aluminum, stainless steel, as well as molybdenum. In other non-limiting embodiments, the layer 110 may include a metallised ceramic material, such as, inter alia, stainless steel embedded in the ceramic material. [0023] In various embodiments, the coating 116 may be formed in multiple layers including any of the materials discussed earlier with respect to the layer 110.

[0024] In use, the blade 112 may be exposed to particularly difficult conditions, including ultrasonic vibrations, heat, as well as corrosion solutions and proteins referred to herein as a surgical material. Accordingly, the specific conditions cause delamination, weakening or wear of the coating 116. Accordingly, the layer 110 should be applied to the body 108 using a suitable application technique that promotes good adhesion between the base material of the body 108 and the layer 110 to prevent or minimize delamination. , weakening or wearing the layer 110 located on the body 108. The layer 110 can be applied to the body using appropriate material application techniques: coating, dipping, spraying, brushing, drying, melting, laser curing, anodising, electroplating, electroless deposition, sintering, melted curing, physical vapor deposition (PVC), chemical vapor deposition (CVD), thermal spraying, HVOF thick coating, as well as other suitable material application techniques. Other well-known application techniques are described in U.S. Patent No. 7,041,088 and U.S. Patent No. 6,663,941. One suitable technique for applying materials is a process developed by Integrated Surgical Sciences, Corp. (ISSC), Sedalia, Colorado, United States. According to an alternative embodiment, the materials for forming the coating 116 or any constituent material forming different layers thereof,

[0025] In various embodiments, the surface treatment or a variety of different surface treatments can be applied to the body 108 using a variety of techniques:

hammering, sandblasting, micro-erosion, bead blasting, knurling, engraving, chemical treatment, such as acid or alkaline etching, laser etching, plasma etching, corona discharge, thermal etching, ripping, cutting, vibrating deburring, machining over-abrasive and other techniques. The surface treatment can advantageously improve the adhesion of the layer 110 to the surface of the body 108. However, care should be taken when using surface treatment to prevent damage to the body 108 during use, which may later lead to damage to the blade 112 in use. For example, surface treatment with beads (bead blasting) can increase stresses in the body of the end effector 108 and may damage the end effector during use. Fig. 4A shows one example of a surface treatment 108A that can be applied to the surface of the body 108 to improve the adhesion of the layer 110 to the surface of the body 108.

[0026] In use, the blade 112, including the coating 116 formed on the body 108, provides several advantages, such as improved cutting and coagulation functions compared to an uncoated blade. In one embodiment, the coating 116 has a coefficient of friction that is less than the coefficient of friction on the base material of the body 108. Thus, the envelope 116 forms a gliding layer over at least a portion of the body 108. The blade 112, including the gliding coating 116, provides several advantages and / or advantages. advantages compared to traditional uncoated end effector blades. For example, the coated blade 112 provides for better tissue cutting (e.g., cutting) along the length of the blade 112, resulting in a more even tissue cutting, improved sealing of the vessels, and uniformity of the tissue layer, as well as better thermal and constructional properties of the blade 112, which facilitates more even cutting of the tissue. The coated blade 112 may further facilitate the even adherence of the serum albumin to the serum along the length of the tissue cutting, thereby minimizing or eliminating discontinuity of adhesion along the length of tissue cutting, as commonly found with conventional uncoated blades. The slip properties of the coating 116 also minimize the adhesion of the surgical material to the surface of the blade 112 during surgical procedures. As previously stated, "surgical material" contains coagulants, proteins, blood, tissue and / or other body fluids that may be present during surgery and cause drying and adhesion of the surfaces of uncoated blades, increasing the impedance of the contact surface of the blade. As previously stated, in order to compensate for the increase in impedance, the ultrasonic generator delivers more and more energy to the blade to continue cutting the tissue until the energy supplied by the generator exceeds the predefined threshold value when the generator turns off or goes into "blocking" mode . As stated earlier, blockage to a state in which the impedance of the end effector is so high that the generator is unable to provide significant amounts of energy to the tissue. Accordingly, by minimizing the deposition, growth or adhesion of the surgical material, the coated blade 112 requires less electrical energy to support the blade 112 during tissue cutting. As a result, the coated blade 112 minimizes the amount of energy provided by the generator and minimizes or prevents the generator blockage phenomenon. [0027] Those skilled in the art will be aware that the ultrasonic end effector blades are relatively efficient and that the electrical energy required to drive the end effector blade is well correlated with the energy delivered to the tissue. Essentially, the lubricity coating 116 reduces the friction between the blade 112 and the tissue, thereby reducing the thermal profile of the blade 112. Since the tissue does not adhere to the skin 116, it is released more easily and more evenly from the blade 112 than the uncoated blade, requiring less average energy consumption (less total energy used) and shorter time (even less total energy used) than the coated blade, providing an unexpected and synergistic effect. In some cases, the time required, for example, to dissect a tissue can be reduced to as much as 34%. In addition, as the coated blade 112 reduces or minimizes the number of generator locks that can occur during the surgical procedure, the coated blade 112 further reduces the overall time required to complete the surgical procedure.

[0028] It is well known that tissue pads tend to degrade and wear over time due to frictional engagement with the blade when there is no tissue between them. However, the lubricity coating 116 also reduces the coefficient of friction between the coated blade 112 and the tissue washer 106, and as a result may extend the life of the tissue washer 106. Therefore, the coated blade 112 can reduce or minimize degradation and deterioration of the tissue pad 104 caused by abrasion and frictional engagement with the blade 112. Thus, the coated blade 112 can substantially extend the service life of the tissue washer 106 as compared to conventional uncoated blades.

[0029] Fig. 3 shows one embodiment of a multi-component end effector 200. In the illustrated embodiment, a multi-component end effector 200 includes a clamp arm assembly 202, shown in an open position, operably coupled to ultrasound surgical blade 212 (blade). The multi-element end effector 200 may be used, for example, in conventional coagulation ultrasonic clamping devices. The clamp arm assembly 202 includes a clamp arm 104 and tissue washer 106 attached to it. The blade 212 is an ultrasound transfer element suitable for use in ultrasound surgical instruments. The body 108, discussed earlier with reference to Figures 1 and 2, forms part of the blade 212. As stated earlier, the body 108 includes a proximal end and a distal end and defines a longitudinal area of ​​action between them. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​action is used to act on the tissue (e.g., cutting, cutting, cutting, coagulation). In one embodiment, the sheath 216 is formed on at least a portion of the outer surface of the body 108 that at least corresponds to the elongated machining area. The coating 216 may comprise at least two layers 210, 214 of materials. In the embodiment shown, the undercoat layer 214 (e.g., the base layer, the first layer) can be formed on the outer surface of the body 108. The cover layer 210 (e.g. upper layer, second layer) may be formed on the primer layer 214. In one embodiment, the cover layer 210 may be formed on a portion of the primer layer 214. The primer layer 214 forms a suitable adhesive joint with the outer surface of the body 108 and is formulated to increase the adhesion of the lidding layer 210 to the body 108. The primer layer 214 and / or the cover layer may comprise a plurality of material layers. The layers 210, 214 may be formed on the body 108 using any suitable material application technique, including using the techniques discussed herein with reference to Figures 1 and 2 (e.g., a coating process developed by ISSC). In one embodiment, the cover layer 210 may be formed on a portion of the undercoat layer 214. The primer layer 214 forms a suitable adhesive joint with the outer surface of the body 108 and is formulated to increase the adhesion of the lidding layer 210 to the body 108. The primer layer 214 and / or the cover layer may contain many layers of materials. The layers 210, 214 may be formed on the body 108 using any suitable material application technique, including using the techniques discussed herein with reference to Figures 1 and 2 (e.g., a coating process developed by ISSC). In one embodiment, the cover layer 210 may be formed on a portion of the undercoat layer 214. The primer layer 214 forms a suitable adhesive joint with the outer surface of the body 108 and is formulated to increase the adhesion of the lidding layer 210 to the body 108. The primer layer 214 and / or the cover layer may contain many layers of materials. The layers 210, 214 may be formed on the body 108 using any suitable material application technique, including using the techniques discussed herein with reference to Figures 1 and 2 (e.g., a coating process developed by ISSC). The primer layer 214 forms a suitable adhesive connection with the outer surface of the body 108 and is formulated to increase the adhesion of the lidding layer 210 to the body 108. The primer layer 214 and / or the cover layer may comprise a plurality of material layers. The layers 210, 214 may be formed on the body 108 using any suitable material application technique, including using the techniques discussed herein with reference to Figures 1 and 2 (e.g., a coating process developed by ISSC). The primer layer 214 forms a suitable adhesive connection with the outer surface of the body 108 and is formulated to increase the adhesion of the lidding layer 210 to the body 108. The primer layer 214 and / or the cover layer may comprise a plurality of material layers. The layers 210, 214 may be formed on the body 108 using any suitable material application technique, including using the techniques discussed herein with reference to Figures 1 and 2 (e.g., a coating process developed by ISSC).

[0030] Fig. 4 is a cross-sectional view of a part of the ultrasonic surgical blade 212 of a multi-component end effector 200 made along the line 4-4 in Fig. 3. As can be seen in the cross-sectional view of Fig. 4, in the embodiment shown the coating 216 includes a plurality of layers 214, 210 of materials. The primer layer 214 is the first layer applied to the body 108. In various embodiments, the primer layer 214 may comprise polymer or polymeric materials and / or ceramics. In various embodiments, primer layer 214 may include FEP or liquid FEP. In one embodiment, primer layer 214 may include alumina or any suitable alumina containing material composition. In another embodiment, primer layer 214 may comprise titanium nitride or any suitable material composition comprising titanium nitride. The cover layer 210 is then applied to the backsheet material 214 to form a topcoat layer 216 that has slip properties similar to the coating 116 discussed earlier with reference to Figures 1 and 2. The cover layer 210 may be applied to a portion of the undercoat layer 214 or be applied to the entire undercoat layer 214. The cover layer 210 may comprise a variety of materials, including polymers and polymer-containing materials. As stated earlier, the term "polymeric materials" and the word "polymer" as used herein, include, but are not limited to, homopolymers, copolymers, terpolymers, and the like. As stated earlier,These and polymer-containing materials include FEP, liquid FEP, FEP / ceramic composites, FEP epoxy liquid ceramic composites, PTFE as well as PTFE / ceramic composites. In other non-limiting embodiments, the lidding layer 210 may include a dry lubricant, such as tungsten disulfide, molybdenum disulfide, graphite, and fluorinated polymers, among others. In further non-limiting embodiments, the lidding layer 210 may include ceramics, e.g., metal oxides, metal nitrides, and also metal carbides, among others. Examples of ceramics include, but are not limited to, chromium carbide, tungsten carbide, titanium nitride, aluminum oxide, and also chromium nitride. In other non-limiting embodiments, the lidding layer 210 may comprise metals. Metals include, among others, aluminum, stainless steel, as well as molybdenum. In other non-limiting embodiments, the lidding layer 210 may include a metallised ceramic material, such as, inter alia, stainless steel embedded in the ceramic material. In one embodiment, the coating layer 210 may be applied using conventional powder coating techniques.

1 and 2 (for example, hammering, micro-erosion, sandblasting, bead blasting, knurling, etching, chemical treatment, such as acid or alkaline digestion, laser etching, plasma etching, corona discharge, heat etching, rooting, notching, as well as other techniques) to generate a predefined surface roughness of RA from about microcales (μ in) to about 256 microliters (0.4064 μm to 6.5024 gm). In one embodiment, the surface treatment can be applied to the outer surface of the body 108 to generate a predefined surface roughness RA, e.g. from about 16 μ in to about 63 μ in (0.4064 gm to 1,6002 gm). However, it is possible to generate other surface roughness.

An undercoat layer 218 comprising titanium nitride provides a good connection to the outer surface of the body 108 without the need for surface treatment. In another embodiment, surface 220 may be obtained using a roughened aluminum oxide coating as undercoat layer 218 to provide a good joining surface for the outer layer 210 having a low coefficient of friction. The aluminum oxide coating can also provide a good connection to the outer surface of the body 108 without the need for surface treatment. In another embodiment, surface 220 may be obtained using a roughened aluminum oxide coating as undercoat layer 218 to provide a good joining surface for the outer layer 210 having a low coefficient of friction. The aluminum oxide coating can also provide a good connection to the outer surface of the body 108 without the need for surface treatment. In another embodiment, surface 220 may be obtained using a roughened aluminum oxide coating as undercoat layer 218 to provide a good joining surface for the outer layer 210 having a low coefficient of friction. The aluminum oxide coating can also provide a good connection to the outer surface of the body 108 without the need for surface treatment.

[0033] Fig. 4C shows an enlarged view of a cross-sectional portion of one embodiment of the blade 216 shown in Fig. 4. As can be seen in Fig. 4C, in one embodiment the undercoat layer 222 can be formed directly on the outer surface of the body 108. In one embodiment In an embodiment, the undercoat layer 222 has a surface that increases or promotes the adhesion of the top layer 210 to the backing layer 222.

[0034] In various embodiments, any of the backsheet layers 214, 218, 222 may comprise alumina, titanium nitride, FEP or liquid FEP that passivates the surface of the body 108 to better adhere the lidding layer 210. In various embodiments, any of the backing layers 214,218,222 may consist essentially of aluminum oxide, titanium nitride, FEP or liquid FEP. In other embodiments, any of the backsheet layers 214, 218, 222 may comprise any of the base materials discussed earlier with reference to Figs. 2-4.

[0035] Fig. 5 shows one embodiment of a multi-component end effector 300. In the illustrated embodiment, a multi-component end effector 300 includes a clamp arm assembly 302, shown in an open position, operably coupled to ultrasound surgical blade 312 (blade). The multi-element end effector 300 may be used, for example, in conventional coagulation ultrasonic clamping devices. The clamping arm assembly 302 includes a clamp arm 104 and a tissue washer 106 attached thereto. The blade 312 is an ultrasound transfer element suitable for use in ultrasound surgical instruments. The body 108, discussed earlier with reference to Figs. 1-4, forms part of the blade 312. As stated earlier, the body 108 includes a proximal end and a distal end and defines a longitudinal area of ​​action between them. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The distal end and longitudinal area of ​​action is used for tissue processing (e.g., cutting, cutting, cutting, coagulation). The surface treatment 310 may be applied to the outer surface of the body 108, which at least corresponds to the longitudinal area of ​​operation. Those skilled in the art will be aware that surface treatment 310 having a defined surface roughness RA can be made using well-known techniques discussed previously with reference to Figure 2, e.g.

4064 μm to 6.5024 gm). In one embodiment, the rough "friction" surface treatment 310 has a predefined surface roughness of RA of about 32 μ in (0.8128 gm). The surface treatment 310 may be applied to the outer surface of the body 108 to assist in frictionally hooking (gripping) the blade 312 and stabilizing the walls of the blood vessels, and consequently to provide improved and more reliable sealing of the vessels. Due to the more rough treatment of the surface 310, the blade 312 remains attached to the tissue long enough to prevent the removal of the vessel walls from the sealing line. As a result, it promotes the transfer of collagen tissue from one side of the sealing line to the other to form a very reliable sealing connection,

[0037] Fig. 7 shows one embodiment of a multi-component end effector 400. In the illustrated embodiment, the multi-component end effector 400 includes a clutch arm assembly 402, shown in an open position, operably coupled to an ultrasonic surgical blade 412 (blade). The multi-element end effector 400 may be used, for example, in a coagulation clamping ultrasound device. The clamping arm assembly 402 includes a clamp arm 104 and tissue washer 106 attached to it. The blade 412 is an ultrasonic transfer element suitable for use in ultrasonic surgical instruments. The body 108, discussed earlier with reference to Figs. 1-6, forms part of the blade 412. As stated earlier, the body 108 includes a proximal end and a distal end and defines a longitudinal area of ​​action between them. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation). In one embodiment, the coating 416 comprising the first material layer 410 may be formed on the outer surface of the body 108 using any of the material application techniques described previously (e.g., a coating process developed by the ISSC). The first layer 410 may comprise any of the polymeric materials, dry lubricants, ceramics, metals,

[0038] Fig. 8 is a cross-sectional view of a portion of the ultrasound blade 412 of multi-component end effector 400 taken along lines 8-8 of Fig. 7. Surface treatment 414 having predefined roughness RA from about 16 .mu. in to about 256 .mu. (0.4064 μm to 6.5024 pm) may be applied to layer 410 using any of the techniques discussed previously with reference to Figure 2. Body 108 defines a longitudinal axis A extending between a proximal end and a distal end. The distal end of the body 108 can move relative to the longitudinal axis A by vibrations generated by the transducer transmitted along the longitudinal axis A. With reference to Figures 7 and 8, in one embodiment, the surface treatment 414, having a predefined surface roughness RA from about 16 μt to about 256 μ in (0.4064 μm to 6.5024 μη) can be used on the first layer 410 or portions thereof. However, other suitable RA surface roughness values ​​can be successfully obtained. For example, surface treatment with predefined surface roughness RA having a coefficient of friction that is greater than the coefficient of friction of the first layer 410 can be applied on the first layer 410 to assist gripping of the blade 412 and stabilize the walls of blood vessels and create better, more reliable sealed vessel connections. The surface treatment 414, having a coefficient of friction slightly greater than the first layer 410, allows the blade 412 to remain attached to the tissue at a sufficient length, to prevent pulling away or shrinking the vessel walls away from the sealing line before the sealing operation is completed. It should be noted that surface treatment 414 can be applied over the body portion 108 to utilize the slip properties of the coating 410 for cutting, while utilizing the rougher part of the surface treatment 414 for the sealing activities.

[0039] Fig. 9 shows one embodiment of a multi-component end effector 500. In the illustrated embodiment, the multi-component end effector 500 includes a clamp arm assembly 502, shown in an open position, operably coupled to ultrasound surgical blade 512 (blade). The multi-element end effector 500 may be used, for example, in conventional coagulation ultrasonic clamping devices. The clamping arm assembly 502 includes a clamp arm 104 and a tissue pad 106 attached thereto. The blade 512 is an ultrasound transfer element suitable for use in ultrasound surgical instruments. The body 108, discussed earlier with reference to Figs. 1-8, forms part of the blade 512. As stated earlier, the body 108 includes a proximal end and a distal end and defines a longitudinal area of ​​action between them. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation).

[0040] Fig. 10 is a cross-sectional view of a portion of the ultrasound blade 512 of multi-element end effector 500 taken along lines 10-10 of Fig. 9. The coating 516 comprising the material layer 510 may be formed on at least a portion of the outer surface of the blade body 108. One or more than one material layer 510 may be molded on the body 108 using any suitable application technique discussed herein (e.g. a coating application process developed by the ISSC).

[0041] Referring to Figs. 9 and 10, in one embodiment, one or more of the material layers 510 may be non-uniformly formed on the blade 512 such that the layer 510 has a variable thickness around the outer surface of the body 108. As shown the layer 510 is formed thicker to support thermal bonding. In one embodiment, the thinner layer 510a may be formed on a portion of the top surface of the body 108, where the blade 516 comes into contact with the tissue washer 106, and thicker material layers 510b may be formed on the side surface portions of the body 108. A layer 510c of any suitable thickness may be formed on a portion of the surface of the bottom body 108 opposite a portion of the top surface. In the embodiment shown, the layer 510c on a part of the surface of the lower body 108 is formed using the same thickness as the thinner layer 510a. In other embodiments, the layer 510c at a portion of the bottom surface of the body 108 may be formed to have the same thickness as thicker layers 510b, thicker than layer 510b or other suitable thicknesses. In other embodiments, multiple layers may be formed to provide different thicknesses on the side portions of the body 108 to prevent excessive thermal damage to these areas of the seal. One or more of the material layers 510 may comprise any of the polymeric materials, dry lubricants, ceramics, metals, and also metallized ceramics discussed earlier with reference to Figure 2. In other embodiments, the primer layer and / or surface treatment can be applied to the outer surface of the body 108 prior to application of one or more of the material layers 510. While one embodiment of the blade 512 includes a backing layer, the backing layer may include any of the base materials discussed earlier with reference to Figures 2 and 4. While one embodiment of the blade 512 includes a surface treatment, the surface treatment may be applied according to the techniques discussed earlier with reference to Figures 2 and 4A.

[0042] Fig. 11 shows one embodiment of a multi-component end effector 700. In the illustrated embodiment, a multi-component end effector 700 includes a clamp arm assembly 702, shown in an open position, operably coupled to an ultrasonic surgical blade 712 (blade). The multi-element end effector 700 can be used, for example, in conventional coagulation ultrasonic clamping devices. The clamping arm assembly 702 includes a clamp arm 104 and a tissue pad 106 attached thereto. The blade 712 is an ultrasound transfer element suitable for use in ultrasonic surgical instruments. The body 108, discussed previously with reference to Figs. 1-10, forms part of the blade 712. As previously stated, body 108 includes a proximal end and a distal end defining an elongated region of action. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​operation are used for tissue operations (e.g., cutting, cutting, cutting, coagulation).

[0043] Fig. 12 shows a cross-sectional view of a portion of the ultrasound blade 712 of a multi-component end effector 700 made along lines 12-12 of Fig. 11. In various embodiments, the shell 716 may be formed on the outer surface of the blade body 108. The coating 716 may comprise one or more layers of materials, surface treatments and / or combinations of the above. In the embodiment shown, the first layer 710 and the second layer 714 are formed on the outer surface of the body 108. In one embodiment, the second layer 714 may be formed on a portion of the first layer 710. One or more layers 710, 714 material may be formed on the body 108 using any suitable material application technique discussed herein (e.g. a coating application process developed by the ISSC). As can be seen in Fig. 12, the blade 712 may comprise a plurality of material layers, each of a different thickness. The first layer 710 may be formed thicker on portions of the side surface of the body 108 and may be formed thinner on portions of the top surface of the body 108, e.g. when the blade 712 contacts the tissue washer 106. The second layer 714 may be formed on the first layer 710. The second layer 714 may be formed thicker on a portion of the upper surface of the body 108 when the blade 712 contacts the tissue washer 106 and is relatively thinner on the side surface portions of the body 108.

[0044] Fig. 13 depicts one embodiment of a one-piece end effector 800. In one embodiment, the one-piece end effector 800 includes an ultrasonic surgical blade 112 (blade) depicted and described with reference to Figs. 1 and 2. The one-piece end effector 800 may be for example, a scalpel, a hook or a ball coagulator. As stated earlier, the sheath 116 may be formed on at least a portion of the outer surface of the body 108. The sheath 116 may also include one or more layers 110 formed on the outer surface of the body 108.

[0045] Fig. 14 is a cross-sectional view of part of the ultrasonic blade 112 of one-piece end effector 800 taken along lines 14-14 of Fig. 13. As can be seen in cross-sectional view of Fig. 14 in the embodiment shown, blade 112 and body 108 may have a substantially circular cross-section. In other embodiments, the shape of the blade 112 can be selected according to the type of end effector to be used, e.g. using any of the shapes described with reference to Figure 2.

[0046] Fig. 15 shows one embodiment of a multi-component end effector 900. In the illustrated embodiment, the multi-component end effector 900 includes a clamp arm assembly 902, shown in an open position, operably coupled to ultrasound surgical blade 912 (blade). The multi-element end effector 900 can be used, for example, in conventional coagulation ultrasonic clamping devices. The clamping arm assembly 902 includes a clamp arm 104 and a tissue pad 106 attached to it. The blade 912 is an ultrasonic transfer element suitable for use in ultrasound surgical instruments. The body 108, discussed earlier with reference to Figs. 1-14, forms part of the blade 912. As stated earlier, body 108 includes a proximal end and a distal end defining an elongated region of action. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation). As stated earlier, the coating 916 may be formed on at least a portion of the outer surface of the body 108. The coating 916 may also include one or more layers 910, 914 formed on the outer surface of the body 108. [0047] FIG. 16 is a cross-sectional view of a portion of the ultrasonic blade 912 a multi-element end effector 900, taken along lines 16-16 in Figure 15. In various embodiments, the coating 916 may be formed on a portion of the outer surface of the blade body 108. In one embodiment, the coating 916 may include a first layer 910 (e.g. a primer layer, a first layer) and a second layer 914 (e.g., an outer layer, a second layer). In one embodiment, the second layer 914 may be formed on a portion of the first layer 910. The first and second layers 910, 914 may comprise any of the polymeric materials, dry lubricants, ceramics, metals, and also metallised ceramics discussed earlier with reference to Figure 2 and 4. In other embodiments, the surface treatment can be applied to the outer surface of the body 108 before applying the first and second layers 910, 914. While one embodiment of the blade 912 includes surface treatment,

[0048] Fig. 17 shows one embodiment of a multi-component end effector 1000. In the illustrated embodiment, a multi-component end effector 1000 includes a clamp arm assembly 1002, shown in an open position, operably coupled to an ultrasonic surgical blade 1012 (blade). The multi-element end effector 1000 can be used, for example, in conventional coagulation ultrasonic clamping devices. The clamping arm assembly 1002 includes a clamp arm 104 and tissue washer 106 attached to it. The blade 1012 is an ultrasound transfer element suitable for use in ultrasonic surgical instruments. The body 108, discussed earlier with reference to Figs. 1-16, forms part of the blade 1012. As stated earlier, body 108 includes a proximal end and a distal end defining an elongated region of action. The proximal end is adapted and configured for coupling to an ultrasound transducer directly or via an ultrasonic transmission waveguide. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation). Coating 1016 may be formed on at least a portion of the outer surface of body 108. Coating 1016 may also include one or more layers 1010, 1014 formed on the outer surface of body 108. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation). Coating 1016 may be formed on at least a portion of the outer surface of body 108. Coating 1016 may also include one or more layers 1010, 1014 formed on the outer surface of body 108. The further ending and area of ​​operation are used for tissue processing (e.g., cutting, cutting, cutting, coagulation). Coating 1016 may be formed on at least a portion of the outer surface of body 108. Coating 1016 may also include one or more layers 1010, 1014 formed on the outer surface of body 108.

[0049] Fig. 18 is a cross-sectional view of a portion of the ultrasound blade 1012 of multi-component end effector 1000 made along lines 18-18 in Fig. 17. In various embodiments, the shell 1016 may be formed on a distal end of the outer surface of the blade body 108. Coating 1016 may include a first layer 1010 (e.g. a primer layer, a first layer) and a second layer 1014 (e.g. an outer layer, a second layer) of a material, a surface treatment, and / or a combination of the above. The first and second layers 1010, 1014 can comprise any of the polymeric materials, dry lubricants, ceramics, metals as well as metallised ceramics discussed earlier with reference to Figures 2 and 4.

[0050] Referring to Figs. 1-18, in various embodiments, the blade 112 (212, 312, 412, 512, 612, 712, 912, 1012) may have, in addition to the circular cross-sectional shape shown, different cross-sectional forms or shapes, which may be inherently symmetrical or asymmetrical. For example, the blade may have square, rectangular, triangular or other polygonal cross-sectional shapes. As stated earlier, in various embodiments, the body 108 can have a series of symmetrical or asymmetrical shapes. For example, the body 108 may be curved in one or more directions. More details on curved or asymmetrical blades are disclosed in US Patent No. 6,283,981.

[0051] In further embodiments, the body 108 may be shaped with a neck or passage that projects from the proximal end of the processing area. The neck part may be configured to be connected to an ultrasonic transmission waveguide e.g. by means of a pin, welding, glue, quick coupling or other suitable attachment means. In various other embodiments, the body 108 and the ultrasonic waveguide may be formed as a single unitary body. In each configuration, the ultrasonic transmission waveguide may have amplification stages to enhance the mechanical vibrations transmitted to the body 108, a solution well known in the art.

[0052] Referring to Figs. 1-18, in one embodiment any of the end effectors described herein (e.g., blades 112, 212, 312, 412, 512, 612, 712, 912, 1012) may comprise molded coatings. from soft or bent material layers to establish frictional engagement (e.g., grasping) with the tissue for improved tight tissue sealing. Examples of bending materials include materials having a Shore D hardness from about 25 to about 70 Shore units. In other embodiments, the end effector may include shells formed of material in combination with other technologies such as augmentation with clips and other fasteners. In other embodiments, the end effector may include a clearance formed along the longitudinal axis A to facilitate aspiration and removal of fluids emanating from the sealed side to prevent excessive damage to the non-added value of the sealed joint portion. In other embodiments, the end effector may comprise a coating formed of one or more layers of materials that are suitable for use in troublesome / rigid tissues, such as cartilage and bone. In other embodiments, the end effector may include a surface treatment that has a roughness RA that is suitable for use in troublesome / rigid tissues such as cartilage and bone. to prevent excessive damage to the non-added value of the leakproof part. In other embodiments, the end effector may comprise a coating formed of one or more layers of materials that are suitable for use in troublesome / rigid tissues, such as cartilage and bone. In other embodiments, the end effector may include a surface treatment that has a roughness RA that is suitable for use in troublesome / rigid tissues such as cartilage and bone. to prevent excessive damage to the non-added value of the leakproof part. In other embodiments, the end effector may comprise a coating formed of one or more layers of materials that are suitable for use in troublesome / rigid tissues, such as cartilage and bone. In other embodiments, the end effector may include a surface treatment that has a roughness RA that is suitable for use in troublesome / rigid tissues such as cartilage and bone. such as cartilage and bone. In other embodiments, the end effector may include a surface treatment that has a roughness RA that is suitable for use in troublesome / rigid tissues such as cartilage and bone. such as cartilage and bone. In other embodiments, the end effector may include a surface treatment that has a roughness RA that is suitable for use in troublesome / rigid tissues such as cartilage and bone.

[0053] The devices disclosed herein may be designed to be removed after one use or may be designed to be used repeatedly. However, in any case, the device may be regenerated for reuse after at least one use. Regeneration can include any combination of steps to disassemble the device, clean or replace individual elements, and then reassemble. In particular, the device may be spread out, and any number of individual elements or parts of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing individual parts, the device can be reassembled for further use in a regeneration plant or surgical team immediately before surgery. Those skilled in the art will be aware that the regeneration of the device may include a number of different techniques for disassembling, cleaning / replacing elements and reassembling.

[0054] Any of the end effectors described herein (e.g., blades 112, 212, 312, 412, 512, 612, 712, 912, 1012) can be regenerated for reuse after at least one use. In one embodiment, the regeneration may comprise obtaining an ultrasonic surgical blade and applying at least one material layer to at least a portion of the body 108 to form a slip coating on the outer surface of the body 108. The lubricity coating may be applied according to any suitable application techniques, including application techniques materials described in this document. The sterilization of the ultrasonic surgical blade is then carried out, after which the ultrasonic surgical blade is stored in a sterile container. In another embodiment, the regeneration may comprise obtaining an ultrasonic surgical blade and applying at least one surface treatment to at least a portion of the body 108 to form a friction coating on the outer surface of the body 108. Surface treatment can be applied in accordance with any suitable surface treatment techniques, including machining techniques surfaces described in this document. The sterilization of the ultrasound surgical blade is then performed and the ultrasonic surgical blade is stored in a sterile container. The surface treatment can be used in accordance with any suitable surface treatment techniques, including the surface treatment techniques described herein. The sterilization of the ultrasound surgical blade is then performed and the ultrasonic surgical blade is stored in a sterile container. The surface treatment can be used in accordance with any suitable surface treatment techniques, including the surface treatment techniques described herein. The sterilization of the ultrasound surgical blade is then performed and the ultrasonic surgical blade is stored in a sterile container.

[0055] Preferably, various examples described herein will be prepared prior to the surgery. First, a new or used device is obtained and cleaned if necessary. The device can then be sterilized. According to one of the sterilization techniques, the device is placed in a closed and sealed package, such as a plastic or TYVEK® bag. The packaging and device are then placed in a radiation field that can penetrate the packaging, such as gamma radiation, X-rays or high-energy electron radiation. Radiation destroys the bacteria on the instrument and in the packaging. The sterilized device can then be stored in a sterile package.

[0056] It is advantageous to carry out the sterilization of the device. This can be accomplished using any method known to those skilled in the art, including beta or gamma radiation, sterilization with ethyl acetate or steam. Accordingly, in one example, an ultrasonic surgical blade comprising a body having a proximal end, a distal end, and an outer surface is obtained, the distal end being movable relative to the longitudinal axis according to the ultrasonic vibrations applied to the proximal end, and the slip coating is formed on at least part of the outer surface of the body. The ultrasonic surgical blade is then sterilized and stored in a sterile container. In another example, an ultrasound surgical blade is obtained comprising a body having a proximal end, a distal end, and an outer surface, the distal end being movable relative to the longitudinal axis by ultrasonic vibrations applied to the proximal end, and a predefined surface treatment having a predetermined ending. the surface roughness is realized on at least part of the body. The ultrasonic surgical blade is then sterilized and stored in a sterile container. wherein the further end may move relative to the longitudinal axis by ultrasonic vibrations applied to the proximal end, and a predefined surface treatment having predefined surface roughness is implemented on at least part of the body. The ultrasonic surgical blade is then sterilized and stored in a sterile container. wherein the further end may move relative to the longitudinal axis by ultrasonic vibrations applied to the proximal end, and a predefined surface treatment having predefined surface roughness is implemented on at least part of the body. The ultrasonic surgical blade is then sterilized and stored in a sterile container.

NZ: 26635 / PE / 16