阅读说明：本技术 具有不粘涂层的电外科组织密封装置 (Electrosurgical tissue sealing device with non-stick coating ) 是由 W·E·鲁滨逊 M·C·巴登 K·P·布拉德利 T·W·鲍彻 于 2018-09-21 设计创作，主要内容包括：本发明题为“具有不粘涂层的电外科组织密封装置”。本发明公开了一种电外科器械,所述电外科器械包括具有导电组织密封板的钳口构件,导电组织密封板被构造成可操作地联接到电外科能量源以便治疗组织。厚度在约35nm至约85nm范围内的聚二甲基硅氧烷涂层设置在组织密封板上。(The invention provides an electrosurgical tissue sealing device with a non-stick coating. An electrosurgical instrument includes a jaw member having an electrically conductive tissue sealing plate configured to be operably coupled to a source of electrosurgical energy for treating tissue. A polydimethylsiloxane coating having a thickness in the range of about 35nm to about 85nm is disposed on the tissue sealing plate.)

1. A method of inhibiting tissue adhesion to an electrically conductive member of an electrosurgical tissue sealing device during application of energy to tissue, the method comprising:

applying a non-stick coating on at least a portion of an electrically conductive member of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique; and

controlling a thickness of the non-stick coating to be about 35nm to about 85nm, wherein the non-stick coating is applied to inhibit tissue adhesion to the electrically conductive member during application of energy to tissue and to allow sensing of at least one tissue parameter resulting from application of energy to tissue.

2. The method of claim 1 wherein said non-stick coating comprises polydimethylsiloxane.

3. A method of inhibiting tissue adhesion to an electrically conductive member of an electrosurgical tissue sealing device during application of energy to tissue, the method comprising:

applying a non-stick coating on at least a portion of an electrically conductive member of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique; and

controlling a thickness of the non-stick coating to about 60nm, wherein the non-stick coating is applied to inhibit tissue adhesion to the electrically conductive member during application of energy to tissue and to allow sensing of at least one tissue parameter resulting from application of energy to tissue.

4. An electrosurgical system comprising:

an electrosurgical energy source;

an electrosurgical instrument configured to be coupled to the source of electrosurgical energy, the electrosurgical instrument comprising:

a pair of opposing jaw members configured to grasp tissue;

a pair of electrically conductive tissue sealing plates coupled to the pair of opposing jaw members, respectively, the pair of electrically conductive tissue sealing plates configured to deliver electrosurgical energy to tissue, the source of electrosurgical energy configured to sense at least one tissue parameter generated by delivery of electrosurgical energy to tissue via the pair of electrically conductive tissue sealing plates; and

a non-stick coating comprising polydimethylsiloxane having a thickness of about 35nm to 85nm, the non-stick coating disposed on at least a portion of each of the pair of conductive tissue sealing plates and the thickness of the non-stick coating being controlled to: reducing adhesion of tissue to each electrically conductive tissue sealing plate; and allowing sensing of the at least one tissue parameter.

5. The electrosurgical system of claim 4, wherein said non-stick coating has a thickness of about 60 nm.

6. The electrosurgical system of claim 4, wherein the at least one tissue parameter is selected from the group consisting of temperature and impedance.

Technical Field

The present disclosure relates to non-stick coatings for electrosurgical tissue sealing instruments. More particularly, the present disclosure relates to a polymeric silicone coating of controlled thickness disposed on at least a portion of opposing jaw members of an electrosurgical tissue sealing device, the thickness achieving desired electrical performance while providing reduced tissue adhesion.

Background

Electrosurgical forceps use mechanical clamping action as well as electrical energy to stop bleeding in the clamped tissue. These forceps (laparotomy, laparoscopic or endoscopic) include a sealing plate that applies energy to the tissue being grasped. By controlling the intensity, frequency, and duration of the energy applied to the tissue through the sealing plate, the surgeon can cut, coagulate, cauterize, and/or seal the tissue.

In the past, many efforts have been made to reduce the adhesion of soft tissue to the sealing plate during energy application. Generally, these efforts have contemplated non-stick surface coatings, such as polytetrafluoroethylene (PTFE, commonly known under the trademark teflon @), for increasing tool surface lubricitySold). However, these materials can interfere with the efficacy and efficiency of hemostasis.

Disclosure of Invention

The electrosurgical instrument described herein includes at least one tissue sealing plate having a non-stick coating configured to reduce adhesion of soft tissue to the sealing plate during application of energy.

In accordance with an embodiment of the present disclosure, an electrosurgical instrument is provided that includes at least one jaw member having an electrically conductive tissue sealing plate configured to be operably coupled to a source of electrosurgical energy for treating tissue; and a polydimethylsiloxane coating disposed on at least a portion of the tissue sealing plate, the polydimethylsiloxane coating having a thickness of about 35nm to about 85 nm.

In one aspect of the present disclosure, the polydimethylsiloxane coating has a thickness of about 60 nm. In another aspect of the disclosure, the polydimethylsiloxane coating has a substantially uniform thickness. In another aspect of the present disclosure, the polydimethylsiloxane coating has a non-uniform thickness. In another aspect of the present disclosure, the polydimethylsiloxane coating is discontinuous. In another aspect of the disclosure, the polydimethylsiloxane coating is continuous. In another aspect of the disclosure, the electrosurgical instrument further includes an insulating layer disposed on at least a portion of the tissue sealing plate. In another aspect of the present disclosure, a polydimethylsiloxane coating is disposed on at least a portion of each of the pair of opposing jaw members. In another aspect of the disclosure, the tissue sealing plate is formed of stainless steel.

In accordance with another embodiment of the present disclosure, an electrosurgical instrument is provided that includes a pair of opposed jaw members. Each of the opposing jaw members comprises an electrically conductive tissue sealing plate configured to be operably coupled to a source of electrosurgical energy for treating tissue; a support base configured to support a tissue sealing plate; and an insulating housing configured to secure the tissue sealing plate to the support base. A polydimethylsiloxane coating having a thickness of about 35nm to 85nm is disposed on at least a portion of at least one of the opposing jaw members.

In one aspect of the disclosure, a polydimethylsiloxane coating is disposed on at least a portion of each of the tissue sealing plate, the support base, and the insulating housing. In another aspect of the present disclosure, the polydimethylsiloxane coating has a thickness of about 60 nm. In another aspect of the disclosure, the polydimethylsiloxane coating has a substantially uniform thickness. In another aspect of the present disclosure, the polydimethylsiloxane coating has a non-uniform thickness. In another aspect of the present disclosure, the polydimethylsiloxane coating is discontinuous. In another aspect of the disclosure, the polydimethylsiloxane coating is continuous.

In accordance with another embodiment of the present disclosure, an electrically conductive tissue sealing plate is provided that includes a stainless steel layer having a first surface and an opposing second surface. The stainless steel layer is configured to deliver energy to tissue. An insulating layer is disposed on the second surface of the stainless steel layer, and a polydimethylsiloxane coating having a thickness of about 35nm to about 85nm is disposed on at least a portion of the first surface of the stainless steel layer.

In one aspect of the present disclosure, the polydimethylsiloxane coating has a thickness of about 60 nm. In another aspect of the present disclosure, the polydimethylsiloxane coating has a non-uniform thickness. In another aspect of the present disclosure, the polydimethylsiloxane coating is discontinuous.

In accordance with another embodiment of the present disclosure, a method of inhibiting tissue from adhering to an electrically conductive member of an electrosurgical tissue sealing device during application of energy to the tissue is provided. The method includes applying a polydimethylsiloxane coating on at least a portion of an electrically conductive component of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique. The method further includes controlling the thickness of the applied polydimethylsiloxane coating to be from about 35nm to about 85 nm.

In accordance with another embodiment of the present disclosure, an electrosurgical instrument is provided that includes a pair of jaw members each having an electrically conductive tissue sealing plate configured to be operably coupled to a source of electrosurgical energy. The tissue sealing plate is configured to deliver electrosurgical energy to tissue based on the at least one sensed tissue parameter. The electrosurgical instrument further includes a non-stick coating disposed on at least a portion of each of the tissue sealing plates. The non-stick coating has a thickness controlled to reduce adhesion of tissue to the electrically conductive sealing plate during delivery of electrosurgical energy to the tissue and to allow sensing of the at least one tissue parameter.

In one aspect of the present disclosure, the non-stick coating can be formed from a precursor starting material comprising hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or a combination thereof. In another aspect of the present disclosure, the polymethyldisiloxane non-stick coating has a thickness of from about 35nm to about 85 nm. In another aspect of the present disclosure, the non-stick coating has a thickness of about 60 nm. In another aspect of the disclosure, the at least one tissue parameter is selected from temperature and impedance.

In accordance with another embodiment of the present disclosure, a method of inhibiting tissue from adhering to an electrically conductive member of an electrosurgical tissue sealing device during application of energy to the tissue is provided. The method includes applying a non-stick coating on at least a portion of an electrically conductive member of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique, and controlling a thickness of the applied non-stick coating to inhibit tissue from sticking to the electrically conductive member during application of energy to the tissue and to allow sensing of at least one tissue parameter generated via application of energy to the tissue.

In one aspect of the present disclosure, the method further comprises controlling the thickness of the non-stick coating to about 35nm to about 85 nm. In another aspect of the disclosure, the non-stick coating comprises hexamethyldisiloxane. In another aspect of the disclosure, the method further comprises controlling the thickness of the non-stick coating to about 60 nm.

In accordance with another embodiment of the present disclosure, an electrosurgical system is provided that includes a source of electrosurgical energy and an electrosurgical instrument configured to be coupled to the source of electrosurgical energy. An electrosurgical instrument includes a pair of opposing jaw members configured to grasp tissue and a pair of electrically conductive tissue sealing plates coupled to the pair of opposing jaw members, respectively. The pair of sealing plates is configured to deliver electrosurgical energy to tissue, and the electrosurgical generator is configured to sense at least one tissue parameter generated by the delivery of electrosurgical energy to the tissue via the sealing plates. The electrosurgical instrument further includes a non-stick coating disposed on at least a portion of each of the tissue sealing plates. The non-stick coating has a thickness controlled to reduce adhesion of tissue to the electrically conductive sealing plate and to allow sensing of the at least one tissue parameter.

In one aspect of the present disclosure, the non-stick coating can be formed from a precursor starting material comprising hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or a combination thereof. In another aspect of the present disclosure, the non-stick coating has a thickness of about 35nm to about 85 nm. In another aspect of the present disclosure, the non-stick coating has a thickness of about 60 nm. In another aspect of the disclosure, the at least one tissue parameter is selected from temperature and impedance.

In accordance with one embodiment of the present disclosure, a method for applying a coating on at least a portion of an electrically conductive member of an electrosurgical tissue sealing device is disclosed. The method comprises the following steps: placing the conductive feature in a plasma deposition chamber; supplying ionizable media into the plasma deposition chamber; igniting the ionizable media at a first power level to generate a first plasma, thereby preparing the conductive member for receiving the coating; supplying an ionizable media and a precursor composition into the plasma deposition chamber; and igniting the ionizable media and precursor composition at a second power level to generate a second plasma to form a coating on the electrically conductive member.

Implementations of the above embodiments may include one or more of the following features wherein the ionizable medium is oxygen and the precursor composition is hexamethyldisiloxane. The method can further include controlling at least one of a ratio of ionizable media to precursor composition, a second plasma duration, or a second power level to adjust a thickness of the coating.

In accordance with another embodiment of the present disclosure, an electrosurgical system is disclosed. The system comprises: an electrosurgical instrument comprising at least one electrically conductive member having a non-stick coating and a storage medium storing data relating to the non-stick coating; an electrosurgical generator configured to generate electrosurgical energy to the at least one electrically conductive member, the electrosurgical generator comprising: a reader configured to interface with a storage medium and read the data; and a controller coupled to the reader and configured to adjust at least one parameter of the electrosurgical energy based on the data. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of these methods.

Implementations of the above-described embodiments may include one or more of the following features. The electrosurgical generator may also include a memory storing an algorithm for controlling the electrosurgical energy. The algorithm parameter may be a treatment completion threshold. The data may include the thickness of the non-stick coating. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium.

In accordance with another embodiment of the present disclosure, a method for reprocessing a coated electrosurgical device is disclosed. The method comprises the following steps: removing the coating by: placing an electrically conductive component of an electrosurgical device into a plasma deposition chamber; supplying a first ionizable medium into the plasma deposition chamber; and igniting the first ionizable medium at a first power level to generate a first plasma to remove the previously used coating from the electrically conductive member. The method further comprises reapplying a new coating by: supplying a second ionizable medium into the plasma deposition chamber; igniting the second ionizable medium at a second power level to generate a second plasma, thereby preparing the conductive member for receiving a new coating; supplying a second ionizable medium and a precursor composition into the plasma deposition chamber; and igniting the second ionizable medium and precursor composition at a third power level to generate a third plasma to form a new coating on the electrically conductive member.

According to one aspect of the above embodiment, the first ionizable medium is tetrafluoromethane, the second ionizable medium is oxygen, and the precursor composition is hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or a combination thereof.

Drawings

The foregoing and other aspects, features and advantages of the electrosurgical tissue sealing instrument of the present invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings wherein:

figure 1 is a perspective view of a laparoscopic bipolar forceps, according to one aspect of the present disclosure;

fig. 2 is a perspective view of an open bipolar forceps according to one aspect of the present disclosure;

fig. 3A and 3B are exploded views of opposing jaw members according to one aspect of the present disclosure;

FIG. 4A is a front cross-sectional view of a seal plate according to one aspect of the present disclosure;

FIG. 4B is a front cross-sectional view of a jaw member according to one aspect of the present disclosure;

FIG. 5 is a flow chart of a method for applying a non-stick coating to a jaw member according to one aspect of the present disclosure;

FIG. 6 is a flow chart of a method for removing a non-stick coating from a jaw member according to one aspect of the present disclosure;

fig. 7 is a perspective view of an electrosurgical system according to one aspect of the present disclosure;

FIG. 8 is a front view of an electrosurgical generator of the electrosurgical system of FIG. 7, according to one aspect of the present disclosure;

FIG. 9 is a schematic view of an electrosurgical generator according to one aspect of the present disclosure; and

FIG. 10 is a graph of adhesion force diagrams for uncoated and coated jaw members according to one aspect of the present disclosure.

Detailed Description

Specific aspects of the electrosurgical tissue sealing instrument of the present invention are described herein below with reference to the drawings; however, it is to be understood that the disclosed aspects are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosed concepts in virtually any appropriately detailed structure.

Like reference numbers may indicate similar or identical elements in the various drawing figures. As shown in the drawings and described throughout the following description, by convention, when referring to relative positioning on a medical instrument, the term "proximal" refers to the end of the device that is closer to the user, and the term "distal" refers to the end of the device that is farther from the user. The term "clinician" refers to any medical professional (i.e., doctor, surgeon, nurse, etc.) performing a medical procedure involving the use of aspects described herein.

As described in more detail below with reference to the figures, the present disclosure is directed to electrosurgical instruments having a non-stick coating disposed on one or more components (e.g., tissue sealing plates, jaw members, electrical leads, insulators, etc.). The thickness of the non-stick coating is carefully controlled to achieve the desired electrical performance while providing reduced tissue adhesion during tissue sealing.

Any material that provides the desired function (i.e., reducing tissue adhesion while maintaining sufficient electrical transmission to allow tissue sealing) can be used as the non-stick coating, provided it is sufficiently biocompatible. The material may be porous to allow electrical transmission. Such materials include silicones and silicone resins, which can be applied using a plasma deposition process to precisely control thickness, and can withstand the heat generated during tissue sealing. Silicone resins suitable for the non-stick coating include, but are not limited to, polydimethylsiloxanes, polyester-modified methylphenylpolysiloxanes (such as polymethylsilanes and polymethylsiloxanes), and hydroxy-functional silicone resins. In some embodiments, the non-stick coating is made from a composition comprising a siloxane, which may include hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or combinations thereof.

In some embodiments, the non-stick coating is a polydimethylsiloxane coating formed by plasma enhanced chemical vapor deposition ("PECVD") of hexamethyldisiloxane ("HMDSO"). Advantageously, the polydimethylsiloxane coating is used to reduce tissue adhesion to the sealing plate and/or the entire jaw member. Additionally, the polydimethylsiloxane coating may be used to reduce pitting of the seal plate and may generally provide durability against electrical and/or mechanical degradation of the seal plate and jaw member.

In some embodiments, the opposing jaw members of the electrosurgical vascular sealing instrument (see fig. 1 and 2) include an electrically conductive tissue sealing plate with a non-stick coating deposited directly thereon. The application of the non-stick coating can be accomplished using any system and process that enables precise control of the thickness of the coating. In some embodiments, the HMDSO is deposited on the sealing plate using Plasma Enhanced Chemical Vapor Deposition (PECVD) or other suitable methods, such as atmospheric pressure plasma enhanced chemical vapor deposition (AP-PECVD). For example, application of the polydimethylsiloxane coating can be accomplished using a system and process that includes a plasma device coupled to a power source, a source of liquid and/or gaseous ionizable media (e.g., oxygen), a pump, and a vacuum chamber. One such exemplary system and process is described in commonly owned U.S. patent application publication No. us 2013/0116682, which is incorporated herein by reference in its entirety. The power source may include any suitable components for delivering power to the plasma device or providing a matched impedance. More specifically, the power source can be any radio frequency generator or other suitable power source capable of generating electrical power to ignite and sustain an ionizable medium to generate a plasma effluent.

The thickness of the non-stick coating affects the non-stick properties of the sealing plate and may also affect the tissue sealing properties of the sealing plate. For example, if the non-stick coating is too thick, the tissue sealing properties of the sealing plate may be adversely affected. More specifically, non-stick coatings exceeding a particular thickness (e.g., greater than about 200nm) may form a uniform dielectric barrier or surface impedance on the sealing plate, which may adversely affect the effectiveness of tissue sensing algorithms employed by electrosurgical generators that control the delivery of electrosurgical energy to the vascular sealing instrument based on sensed tissue parameters (e.g., impedance, temperature, etc.) generated by the application of electrosurgical energy to tissue via the sealing plate. If the non-stick coating applied is too thin (e.g., less than about 20nm), the non-stick coating may not provide sufficient reduction in tissue adhesion.

Embodiments of the present disclosure provide for disposing a non-stick coating on a component of a vascular sealing instrument (e.g., a sealing plate, a jaw member, an electrical lead, an insulator, etc.) at a particular thickness or a particular range of thicknesses such that the non-stick coating provides sufficient reduction of tissue adhesion during tissue sealing without adversely affecting the tissue sealing performance of the vascular sealing instrument.

In some embodiments, the polydimethylsiloxane coating may be applied to a portion of the electrosurgical device at a thickness of about 20nm to about 200nm, in embodiments the coating may be about 25nm to about 120nm, and in further embodiments, about 35nm to about 85 nm. In particular embodiments, the non-stick coating may be about 60nm thick. In some embodiments, the thickness of the non-stick coating can vary such that the non-stick coating has a substantially non-uniform thickness. For example, the first portion of the non-stick coating may be about 60nm thick, and any one or more other portions of the non-stick coating may have a thickness other than about 60nm, but in the range of about 20nm to about 200nm, in embodiments in the range of about 25nm to about 120nm, and in further embodiments, in the range of about 35nm to about 85 nm. In other embodiments, the non-stick coating has a substantially uniform thickness. Without wishing to be bound by any particular theory, it is believed that a polydimethylsiloxane coating in the above-described range does not provide a complete surface seal, and it is the lack of a completely uniform seal over the surface at these controlled thicknesses that allows the electrical algorithms of certain electrosurgical generators to perform properly. One such electrosurgical generator employing a tissue sensing algorithm is described in U.S. patent No.9,603,752, which is incorporated herein by reference in its entirety. Other electrosurgical generators employing other algorithms will be readily envisioned by those of skill in the art reviewing this disclosure.

In some embodiments, the thickness of the non-stick coating is about 0.01% of the thickness of the seal plate.

Turning now to FIG. 1, an instrument, generally identified as forceps 10, is used in various surgical procedures and includes a housing 20, a handle assembly 30, a rotation assembly 80, a trigger assembly 70, and an end effector 130 that cooperate to grasp, seal, and separate tubular vessels and vascular tissue. Forceps 10 includes a shaft 12 extending from a distal end of a housing 20. The shaft 12 has a distal end 16 configured to mechanically engage the end effector 130 and a proximal end 14 configured to mechanically engage the housing 20.

End effector 130 includes opposing jaw members 110 and 120 that cooperate to effectively grasp tissue for sealing purposes. Both jaw members 110 and 120 pivot relative to each other about a pivot pin (not shown). Alternatively, forceps 10 may include a jaw member 110 that is movable relative to a fixed jaw member 120, and vice versa. Jaw members 110 and 120 can be curved to facilitate manipulation of tissue and to provide a better "line of sight" for accessing the target tissue. Sensor 140 may be disposed on or near at least one of jaw members 110 and 120 to sense a tissue parameter (e.g., temperature, impedance, etc.) generated by the application of electrosurgical energy to tissue via jaw members 110 and 120. The sensors 140 may include temperature sensors, tissue hydration sensors, impedance sensors, optical transparency sensors, jaw gap sensors, strain and/or force sensors, and the like. The sensed tissue parameters may be transmitted as data to an electrosurgical generator (not shown) having suitable data processing components (e.g., a microcontroller, memory, sensor circuitry, etc.) for controlling the delivery of electrosurgical energy to the forceps 10 based on data received from the sensors 140 by a cable (not shown) coupling the forceps 10 to the electrosurgical generator (not shown).

Examples of clamps are shown and described in U.S. patent application publication No.2013/0296922 and U.S. patent No.9,655,673, the entire contents of each of which are incorporated herein by reference.

With respect to fig. 2, an open forceps 100 for use in various surgical procedures is shown. The forceps 100 include a pair of opposed shafts 116 and 126 having an end effector 200 disposed at the distal ends of the shafts 116, 126. End effector 200 includes a pair of opposed jaw members 210 and 220 that are connected about pivot member 150 and are movable relative to one another to grasp tissue. Each shaft 116 and 126 includes a handle 118 and 128, respectively, to facilitate movement of shafts 116 and 126 relative to each other to pivot jaw members 210 and 220 between an open position, wherein jaw members 210 and 220 are disposed in a spaced apart relationship relative to each other, and a closed position, wherein jaw members 210 and 220 cooperate to grasp tissue therebetween. Similar to forceps 10 shown in fig. 1, sensor 240 may be disposed on or near at least one of jaw members 210 and 220 of forceps 100 in order to sense a tissue parameter (e.g., temperature, impedance, etc.) generated by the application of electrosurgical energy to tissue via jaw members 210 and 220. The sensors 240 may include temperature sensors, tissue hydration sensors, impedance sensors, optical transparency sensors, and the like. The sensed tissue parameters may be transmitted as data to an electrosurgical generator (not shown) having suitable data processing components (e.g., a microcontroller, memory, sensor circuitry, etc.) for controlling the delivery of electrosurgical energy to the forceps 100 based on data received from the sensor 240, by a cable (not shown) coupling the forceps 100 to the electrosurgical generator (not shown).

Fig. 3A and 3B illustrate perspective views of jaw members 310 and 320, respectively, according to embodiments of the present disclosure. Jaw members 310 and 320 can be utilized with endoscopic forceps 10 (fig. 1) or open forceps 100 (fig. 2) and operate in a manner similar to that described above for jaw members 110 and 120 (fig. 1) and jaw members 210 and 220 (fig. 2). Each of jaw members 310 and 320 includes: respective seal plates 312 and 322; respective electrical leads 325a and 325 b; and support bases 319 and 329 extending distally from flanges 313 and 323, respectively.

Each of the seal plates 312 and 322 includes an underside 328a and 328b, respectively, which may include a respective electrically insulating layer 330a and 330b bonded thereto or otherwise disposed thereon. The electrical insulation layers 330a and 330b serve to electrically insulate the respective seal plates 312 and 322 from the respective support bases 319 and 329. In addition, the electrically insulating layers 330a and 330b serve to prevent or slow the occurrence of corrosion of the seal plates 312 and 322 (at least on the undersides 328a,328b thereof), respectively. In one embodiment, electrically insulating layers 330a and 330b may be formed of polyimide. However, in other embodiments, any suitable electrically insulating material may be utilized, such as polycarbonate, polyethylene, and the like.

In addition, each of jaw members 310 and 320 includes an outer surface 311a and 311b, respectively, that includes a non-stick (e.g., polydimethylsiloxane) coating 400 disposed thereon. Non-stick coating 400 can be disposed on selective portions of either jaw members 310 and 320, or can be disposed on the entire outer surfaces 311a and 311 b. In some embodiments, a non-stick coating 400 is disposed on tissue engaging surfaces 317a and 317b of sealing plates 312 and 322, respectively. Non-stick coating 400 serves to reduce tissue adhesion to sealing plates 312 and 322, jaw members 310 and 320, electrical leads 325a and 325b, and/or surrounding insulation.

The support bases 319 and 329 are configured to support the seal plates 312 and 322 thereon. The seal plates 312 and 322 may be attached atop the support bases 319 and 329, respectively, by any suitable method, including but not limited to snap-fitting, overmolding, stamping, ultrasonic welding, laser welding, and the like. The support bases 319 and 329 and the seal plates 312 and 322 are at least partially encapsulated by the insulative housings 316 and 326, respectively, by an overmolding process to secure the seal plates 312 and 322 to the support bases 319 and 329, respectively. Seal plates 312 and 322 are coupled to electrical leads 325a and 325b, respectively, via any suitable method (e.g., ultrasonic welding, crimping, welding, etc.). Electrical leads 325a and 325b are used to deliver electrosurgical energy (e.g., from an electrosurgical energy generator) to the sealing plates 312 and 322, respectively. More specifically, electrical lead 325a supplies a first potential to seal plate 312 and electrical lead 325b supplies a second potential to the opposing seal plate 322.

Jaw member 320 (and/or jaw member 310) may further include a series of stop members 390 disposed on tissue engaging surface 311b of sealing plate 322 to facilitate the grasping and manipulation of tissue and to define a gap between jaw members 310 and 320 during sealing and cutting of tissue. The series of stop members 390 may be disposed (e.g., formed, deposited, painted, attached, coupled, etc.) onto the sealing plate 322 during manufacturing. Some or all of stop members 390 may be coated with a non-stick coating 400, or alternatively, may be disposed on top of non-stick coating 400.

Sealing plates 312 and 322 may include longitudinal knife channels 315a and 315b, respectively, defined therethrough and configured to receive a knife blade (not shown) that reciprocates within knife channels 315a and 315b to cut tissue. The electrical insulation layers 330a and 330b disposed on the respective undersides 328a and 328b of the seal plates 312 and 322, respectively, allow for various blade configurations, such as, for example, T-shaped blades or I-shaped blades, which may contact the undersides (and/or insulation layers) of the seal plates during reciprocation in the knife slots 315a,315 b. That is, the electrically insulating layers 330a,330b serve to protect the blades and the undersides 328a and 328b of the seal plates 312 and 322, respectively, from damage or wear. Further, where electrically conductive blades are utilized (e.g., for electrical tissue cutting), the electrically insulating layers 330a,330b help to electrically insulate the sealing plates 312,322 from the electrically conductive blades.

Turning now to FIG. 4A, a front cross-sectional view of the seal plate 312 is shown and will be described. The seal plate 312 has a stainless steel layer 317, a non-stick coating 400, and optionally an electrically insulating layer 330a disposed on an underside 328b of the stainless steel layer 317. A non-stick coating 400 may be applied to at least the outer surface 311a of the stainless steel layer 317. Bonding the electrically insulating layer 330a to the stainless steel layer 317 may be accomplished by any suitable method, including but not limited to applying an adhesive between the electrically insulating layer 330a and the stainless steel layer 317, bonding the electrically insulating layer 330a to the stainless steel layer 317 using a thermal treatment, and/or any combination thereof. Optional electrically insulating layer 330a may have a thickness in the range of about 0.0005 inches to about 0.01 inches.

The non-stick coating 400 may be discontinuous or continuous. In some embodiments, the discontinuity or continuity of the non-stick coating 400 can depend on the thickness of the non-stick coating 400. In some embodiments, the non-stick coating may be continuous over the entire sealing plate 312, thereby hermetically sealing the sealing plate 312. In some embodiments, the non-stick coating may be discontinuous over the entire sealing plate 312. A discontinuous non-stick coating may be applied intermittently to the seal plate 312 using a suitable discontinuous coating or sheet-coating (patch-coating) process. The spotty nature of the discontinuous non-stick coating may allow the thickness of the discontinuous non-stick coating to be increased relative to the continuous non-stick coating while maintaining sufficient non-stick and tissue sealing properties.

In some embodiments, the seal plate 312 may be formed by: the sheet of electrically insulating material is bonded to the stainless steel sheet and the stainless steel sheet is coated with a non-stick coating. Once the two materials are bonded together and the stainless steel sheet is coated with the non-stick layer 400, the seal plate 312 may be formed by stamping, machining, or any other suitable method for forming a seal plate.

In some embodiments, the seal plate 312 may be first formed by stamping, machining, or any other suitable method for forming a seal plate. Once the seal plate 312 is formed, the non-stick layer 400 is applied to the seal plate 312 prior to assembly of the jaw member 310. Once the seal plate 312 is coated with the non-stick layer 400, the seal plate 312 may be attached atop the support base 319, secured to the support base 319 via the insulative housing 316, and coupled to electrical leads 325a (as described above with respect to fig. 3A) to form the jaw member 310. Optionally, once jaw member 310 is formed, a non-stick coating can be applied to other components of jaw member 310 (e.g., support base 319, insulating housing 316, electrical leads 325a, etc.). In some embodiments, a non-stick coating may be applied to other components of pliers 10 (fig. 1) or pliers 100 (fig. 2) to reduce frictional binding associated with the operation of these devices. For example, a non-stick coating may be applied to shaft 12 of pliers 10, to pivot member 150 and opposing shafts 116 and 126 of pliers 100, and/or to a blade (not shown) used with pliers 10 or pliers 100.

Turning now to FIG. 4B, a front cross-sectional view of jaw member 310 is shown and will be described. Jaw member 310 includes a seal plate 312 having a stainless steel layer 317 and an optional electrically insulating layer 330 a. The seal plate 312 is attached to the support base 319 via any suitable process. In addition, with the seal plate 312 secured to the support base 319, the combined seal plate 312 and support base 319 are secured to the insulating housing 316 via any suitable process. A non-stick coating 400 is applied to the outer surface 311a of the assembled seal plate 312, support base 319, insulating housing 316, and optional electrical lead 325a (fig. 3A). In some embodiments, it may be useful to partially coat outer surface 311a of jaw member 310 or include a thicker layer of non-stick coating 400 on a different portion of outer surface 311a of jaw member 310.

Additionally or alternatively, in some embodiments, the seal plate 312 may be coated with a non-stick coating 400 in the manner described above with respect to fig. 4A, and the outer surface 311a of the jaw member 310 may also be coated with a non-stick coating 400.

Once non-stick coating 400 is disposed on seal plates 312 and 322 and/or jaw member 310, these seal plates and/or jaw members can be assembled (e.g., pivotably coupled together) with the opposing jaw member to form an end effector (e.g., end effector 130 or end effector 200). In some embodiments, non-stick coating 400 may be disposed on seal plates 312 and 322 and/or jaw member 310 after assembly of the end effector.

In some embodiments, a polydimethylsiloxane coating of the above thicknesses or within the above thicknesses ranges may be combined with one or more additional coatings. For example, the one or more coatings may be deposited directly on the stainless steel layer of the sealing plate prior to depositing the dimethicone coating such that the dimethicone coating is deposited directly on the one or more coatings and not directly on the stainless steel layer of the sealing plate. For example, U.S. publication No.2017/0119457 describes a vascular sealing device having a sealing plate with an HMDSO-based coating disposed over a chromium nitride ("CrN") coating.

Referring to FIG. 5, a flow chart illustrating a method for forming the non-stick coating 400 is disclosed. It is contemplated that the method may be performed using any suitable chemical vapor deposition or plasma vacuum system, such as the system disclosed in U.S. patent No.8,187,484, ION 140 plasma system available from popupol corporation of viettenberg, Germany (PVA TEPLA AG, Wettenberg, Germany), and the like.

An uncoated jaw member (e.g., jaw member 310) is loaded into a vacuum plasma deposition chamber of a plasma system. The chamber is then evacuated to form a vacuum within the chamber. After the vacuum is established, ionizable media (such as oxygen) is supplied into the chamber at any suitable rate until the set point pressure is reached. The oxygen flow rate may be about 100 standard cubic centimeters per minute (SCCM) to about 1,000SCCM, and in embodiments, the flow rate may be about 150 SCCM. The set point pressure may be 600 mtorr to about 1,000 mtorr, and in an embodiment, the pressure may be 800 mtorr. Once the desired pressure is reached, the oxygen plasma is ignited at a first power level for a first period of time to prepare the surface for coating. The first time period may be about 3 minutes and the first power level may be 300 watts. The oxygen-based plasma removes residual organic impurities and weakly binds organic contaminants from the jaw member. It also prepares the surface for subsequent treatment (e.g., application of the non-stick coating 400), improves surface coverage and enhances adhesion of the non-stick coating 400.

After the oxygen-based plasma application is completed, the chamber is again evacuated until a vacuum is established. Oxygen and the precursor material used to form non-stick coating 400 (such as hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane) are supplied into the evacuated chamber at their respective flow rates until the set point pressure is reached. The oxygen flow rate may be about 10 to about 50SCCM, and in embodiments, the flow rate may be about 15 SCCM. The silicone precursor flow rate may be from about 10SCCM to about 50SCCM, and in embodiments, the flow rate may be about 11 SCCM. The set point pressure may be about 100 mtorr to about 500 mtorr, and in an embodiment, the set point pressure may be about 200 mtorr. Once the desired pressure is reached, the plasma is ignited at a second power level for a second period of time. The second time period may be about 1.5 minutes and the second power level may be 100 watts. The chamber is then evacuated and vented again. At this stage of the process, the non-stick coating 400 is formed. Specifically, the polydimethylsiloxane forms the non-stick coating 400 as the precursor polymerizes. The thickness of the non-stick coating 400 can be adjusted by controlling one or more of the following parameters including, but not limited to, the ratio of gases (e.g., oxygen to organosilicon precursor), the duration of plasma application, and the power at which the gases are ionized.

Referring to fig. 6, a process for removing the non-stick coating 400 is described. The process may be performed at a reprocessing facility that reconditions previously used medical devices. After forceps 10 have been used and jaw members 110 and 120 are covered in eschar and other tissue byproducts formed as a result of the electrosurgical treatment, non-stick coating 400 can be removed using the process of fig. 6 and a new coating applied as described above with respect to fig. 5.

Reprocessing may involve completely or partially disassembling pliers 10, and in particular, removing jaw members 110 and 120 from shaft 12. Forceps 10 may also be sterilized. Sterilization of forceps 10 may be performed before or after disassembly. Once jaw members 110 and 120 are disassembled, jaw members 110 and 120 are placed into a chamber of a plasma system to remove non-stick coating 400. In some embodiments, jaw members 110 and 120 can also be sterilized using a removal process as described below in fig. 6.

Referring to fig. 6, after loading the used jaw member into the chamber, the chamber is evacuated until a vacuum is established. Oxygen and tetrafluoromethane are supplied to the evacuated chamber at their respective flow rates until the set point pressure is reached. The oxygen flow rate may be about 10 to about 50SCCM, and in embodiments, may be about 25 SCCM. The tetrafluoromethane flow rate may be from about 75SCCM to about 200SCCM, and in embodiments, may be about 125 SCCM. The set point pressure may be about 100 mtorr to about 700 mtorr, and in an embodiment, the set point pressure may be about 400 mtorr. Once the desired pressure is reached, the plasma is ignited at progressively higher power levels over a plurality of time periods (e.g., first, second, third, fourth time periods, etc.). The first three time periods may be about the same amount of time, with the last time period being the longest and applying power at the highest level. The first time period may be about 15 seconds and the first power level may be 150 watts. The second time period may be about 15 seconds and the second power level may be 300 watts. The third time period may be about 15 seconds and the third power level may be 450 watts. The fourth time period may be about 3.25 minutes and the fourth power level may be 600 watts. After this process, the non-stick coating 400 is removed.

Once the non-stick coating 400 is removed, the chamber is evacuated. After the vacuum is established, oxygen is supplied to the chamber at any suitable rate until the set point pressure is reached. The gas flow rate may be about 50 to about 400SCCM, and in embodiments, the flow rate may be about 150 SCCM. The set point pressure may be 200 mtorr to about 6,000 mtorr, and in an embodiment, the pressure may be 400 mtorr. Once the desired pressure is reached, an oxygen plasma is ignited at a fifth power level for a fifth period of time to complete the second layer. The fifth time period may be about 1 minute and the fifth power level may be 600 watts. The chamber is then evacuated and vented again. After the oxygen plasma is applied, jaw members 110 and 120 are cleaned and non-stick coating 400 can be reapplied by the reprocessor as described above with respect to fig. 5. In particular, jaw members 110 and 120, once coated, may then be reassembled with the previously sterilized components of pliers 10.

Fig. 7 is a perspective view of components of an exemplary embodiment of an electrosurgical system 610 according to the present disclosure. System 610 may include an electrosurgical generator 700 configured to be coupled to forceps 10 (fig. 1), forceps 100 (fig. 2), or any other suitable electrosurgical instrument. One of the jaw members 110 or 120 of the forceps 10 acts as an active electrode and the other jaw member is a return electrode. Electrosurgical alternating RF current is supplied by the generator 700 to the active electrodes of the forceps 10 via a power supply line 624 connected to the active terminal 730 (fig. 7) of the generator 700. The alternating RF current is returned from the return electrode to the generator 700 via a return line 628 at a return terminal 632 (fig. 7) of the generator 700. The power line 624 and return line 628 may be enclosed in a cable 638.

Forceps 10 may be coupled to generator 700 at a port having connections (e.g., pins) to active terminal 730 and return terminal 732 via a plug (not shown) disposed at an end of cable 638, where the plug includes contacts from power line 624 and return line 628, as described in more detail below.

Referring to fig. 8, a front side 740 of generator 700 is shown. Generator 700 may include a plurality of ports 750 and 762 to accommodate various types of electrosurgical instruments (e.g., monopolar electrosurgical instruments, forceps 10, forceps 100, etc.).

Generator 700 includes a user interface 741 having one or more display screens 742,744,746 to provide a user with a variety of output information (e.g., intensity settings, treatment completion indicators, etc.). Each of screens 742,744,746 is associated with a corresponding port 750-762. Generator 700 includes suitable input controls (e.g., buttons, actuators, switches, touch screens, etc.) for controlling generator 700. Screen 742,744,746 is also configured as a touch screen that displays corresponding menus of the device (e.g., forceps 10). The user then adjusts the input by simply touching the corresponding menu option.

Screen 642 controls the unipolar output and devices connected to ports 750 and 752. Port 750 is configured to couple to a monopolar electrosurgical instrument, and port 752 is configured to couple to a foot switch (not shown). The foot pedal may be used to provide additional inputs (e.g., repeated inputs to generator 700). The screen 744 controls the unipolar and bipolar outputs and the devices connected to the ports 756 and 758. Port 756 is configured to couple to other monopolar instruments. The port 758 is configured to couple to a bipolar instrument (not shown).

Screen 746 controls the insertion of clip 10 into one of ports 760 and 762, respectively. Generator 700 outputs energy through ports 760 and 762 suitable for sealing tissue grasped by forceps 10. In particular, screen 746 outputs a user interface that allows a user to enter user-defined intensity settings for each of ports 760 and 762. The user-defined setting may be any setting that allows a user to adjust one or more energy delivery parameters (such as power, current, voltage, energy, etc.) or sealing parameters (such as energy rate limiter, sealing duration, etc.). The user-defined settings are transmitted to the controller 724 (FIG. 9), where the settings may be saved in memory. In embodiments, the intensity setting may be a numerical scale, such as, for example, from one to ten or from one to five. In an embodiment, the intensity setting may be associated with an output curve of the generator 700. The intensity settings may be specific to each forceps 10 utilized such that the various instruments provide the user with a particular intensity scale corresponding to forceps 10. Active terminal 730 and return terminal 732 (fig. 9) may be coupled to any of the desired ports 750 and 762.

With continued reference to fig. 8, each of ports 750-762 may include a reader, such as an optical reader or a radio frequency interrogator, configured to communicate with forceps 10 to extract data related to forceps 10. Such data may be encoded in a bar code, RFID tag, computer readable memory, or any other data storage medium 640 that may be provided on the forceps 10 or any component thereof, such as the cable 638. In an embodiment, this data can include whether forceps 10 include coated or uncoated jaw members 110 and 120. In further embodiments, the data may also include characteristics of the coating, such as its thickness, dielectric properties, current and voltage limits, temperature limits, and the like.

Fig. 9 shows a schematic block diagram of a generator 700 comprising a controller 724, a power supply 727 and a power converter 728. The power supply 727 may be a high voltage DC power supply connected to an AC source (e.g., line voltage) and provides high voltage DC power to the power converter 728, which then converts the high voltage DC power to RF energy and delivers the energy to the active terminals 730. Energy is returned thereto via return terminal 732. Active terminal 730 and return terminal 732 are coupled to power converter 728 through an isolation transformer 729.

The power converter 728 is configured to operate in multiple modes during which the generator 700 outputs corresponding waveforms having particular duty cycles, peak voltages, crest factors, and the like. It is contemplated that in other embodiments, generator 700 may be based on other types of suitable power supply topologies. The power converter 728 may be a resonant RF amplifier or a non-resonant RF amplifier, as shown. As used herein, a non-resonant RF amplifier refers to an amplifier that lacks any tuning components (i.e., inductors, capacitors, etc.) disposed between the power converter and the load "Z" (e.g., tissue coupled by the forceps 10).

The controller 724 includes a processor (not shown) operatively connected to memory (not shown) that may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), Random Access Memory (RAM), electrically erasable programmable ROM (eeprom), non-volatile RAM (nvram), or flash memory. The processor may be any suitable processor (e.g., control circuitry) suitable for performing the operations, calculations and/or sets of instructions described in this disclosure, including but not limited to a hardware processor, a Field Programmable Gate Array (FPGA), a Digital Signal Processor (DSP), a Central Processing Unit (CPU), a microprocessor and combinations thereof. Those skilled in the art will appreciate that the processor may be replaced by any logic control circuitry suitable for performing calculations and/or executing the sets of instructions described herein.

The controller 724 includes an output port operatively connected to the power supply 727 and/or the power converter 728, allowing the processor to control the output of the generator 700 according to an open and/or closed control loop scheme. The closed loop control scheme is a feedback control loop in which a plurality of sensors measure a variety of tissue and energy characteristics (e.g., tissue impedance, tissue temperature, output power, current and/or voltage, etc.) and provide feedback to the controller 724. The controller 724 then controls the power supply 727 and/or the power converter 728 to regulate the DC and/or power supply, respectively.

The generator 700 according to the present disclosure may also include a plurality of sensors (not shown). These sensors may be coupled to the power source 727 and/or the power converter 728 and may be configured to sense the DC current supplied to the power converter 728 and/or characteristics of the RF energy output by the power converter 728, respectively. Controller 724 also receives input signals from generator 700 and/or input controls of clamp 10. The controller 724 uses the input signals to regulate and/or perform other control functions on the power output by the generator 700.

The power converter 728 includes a plurality of switching elements 728a-728d arranged in an H-bridge topology. In an embodiment, the power converter 728 may be configured according to any suitable topology including, but not limited to, a half-bridge, a full-bridge, a push-pull, and the like. Suitable switching elements include voltage-controlled devices such as transistors, Field Effect Transistors (FETs), combinations thereof, and the like. In an embodiment, the FET may be formed of gallium nitride, aluminum nitride, boron nitride, silicon carbide, or any other suitable wide band gap material. In further embodiments, the FET may be any suitable FET, such as a conventional silicon FET.

The controller 724 is in communication with both the power supply 727 and the power converter 728. Controller 724 is configured to output control signals, which may be pulse width modulated ("PWM") signals, to switching elements 728a-728d, as described in more detail in co-pending application published as U.S. patent application publication No.2014/0254221, the entire contents of which are incorporated herein by reference. In particular, the controller 724 is configured to modulate a control signal d1 supplied to the power supply 727 and a control signal d2 supplied to the switching elements 728a-728d of the power converter 728. Additionally, the controller 724 is configured to calculate a power characteristic of the generator 700 and control the generator 700 based at least in part on the measured power characteristic.

The controller 724 is configured to execute a vessel sealing algorithm that controls the output of the generator 700 to treat tissue (e.g., seal a vessel). Exemplary algorithms are disclosed in commonly owned U.S. patent No.8,147,485 and U.S. patent application publication No.2016/0045248, the entire disclosures of all of which are incorporated herein by reference.

Algorithms according to the present disclosure may be embodied as software instructions executable by the controller 724. In an embodiment, the algorithm may be an impedance-based energy delivery algorithm, wherein energy is delivered by the generator 700 to the tissue until a predetermined impedance threshold is reached, or otherwise controlled based on the measured tissue impedance. In view of non-stick coating 400, storage medium 640 of caliper 10 may include data related to non-stick coating 400 as described above. During use, controller 724 may extract data related to non-stick coating 400 from the storage medium and adjust the vessel sealing algorithm based on one or more coating characteristics extracted from storage medium 640. More specifically, the controller 724 may be configured to adjust one or more parameters of the vessel sealing algorithm based on the coating characteristics extracted from the storage medium 640. In an embodiment, the algorithm may include a completion threshold (e.g., impedance, phase difference, etc.) that the controller 724 uses to determine whether the vessel sealing is complete. Controller 724 may be configured to adjust the completion threshold based on data relating to non-stick coating 400. In an embodiment, the controller 724 may be configured to adjust other parameters of the energy delivery algorithm based on the coating data stored in the storage medium 640. This allows generator 700 to adjust the energy application based on whether jaw members 110 and 120 of forceps 10 are coated or uncoated, as non-stick coating 400 can affect the dielectric and electrical properties of forceps 10.

All numbers and ranges disclosed above may be varied by some amount. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number and any included range falling within the range is specifically disclosed. In particular, each range of values (of the form "from about a to about b," or, equivalently, "from about a to b," or, equivalently, "from about a-b") disclosed herein is to be understood as setting forth each number and range encompassed within the broader range of values. Unless expressly stated to the contrary, all ranges set forth herein are to be considered as being inclusive of the endpoints. As used herein, unless otherwise indicated herein or otherwise evident from the context, the term "about" when used in conjunction with a stated value or range means slightly greater than or slightly less than the stated value or range with a deviation within ± 10% of the stated value or range.

Examples

Example 1

This example compares an uncoated jaw member with a jaw member having a non-stick coating formed from plasma polymerization of HMDSO according to the present disclosure.

In this example, LIGASURE available from Medtronic, Minneapolis, MN, Minneapolis, Minn, Inc. was used^TMLF4318 IMPACT^TMFour sets of jaw members of the instrument.Three of the jaw members were coated at three different thicknesses of 50nm, 100nm and 150 nm. The fourth jaw member remains uncoated.

During testing, the jaw members were attached to VALLEYLAB available from Medtronic, Minneapolis, MN^TMFORCETRIAD^TMAn electrosurgical generator. The generator is used to energize the jaw members to seal tissue for testing. A force measurement station is also established that includes a motor coupled to the drive rod to open and close the jaw members. The jaw members are also enclosed in a dielectric tissue clamp surrounding the jaw members, which allows for additional clamping around the tissue. The drive rod is connected to a bidirectional load cell connected to a National Instruments, Austin, TX, available from Ostin, TexasIn order to record load cell measurements.And also for controlling the motor to open and close the jaw members.

Porcine uterine mesentery was used as test tissue. During testing, the jaw members are closed by the motor and the generator is activated to seal tissue. After the seal is completed, the jaws are held in place while the jaw members are opened. The load cell measures force during opening of the jaw member, anThe maximum force observed was recorded as the blocking force. Each of the four jaw members was tested approximately one hundred times. Blank opening force (e.g., tissue without a seal) is measured approximately every twenty seals to account for variable opening forces of the different jaw members. This blank force value was used as a calibration value and subtracted from the recorded blocking force for each subsequent seal.

Referring to fig. 10, which shows an adhesion force diagram for each of the jaw members, all three coated devices exhibited an adhesion force of about 0 lbf throughout the test. There was no measurable difference in the adhesion force of the three coated jaw members. However, the uncoated device showed an adhesion force of about 1 lbf at the beginning of the test sequence and increased to 6 lbf by the end of 100 seals.

While there was no measurable difference in the average adhesion force of the three coated jaw members, there was a visual difference in the jaws after sealing was complete. The uncoated control jaw member has a significant eschar build-up on the housing portion of the jaw and some eschar build-up on the sealing plate itself. The 50nm coated jaw member had some blood and a spot eschar build-up on the plastic. The jaw member with 100nm coating had very little blood and eschar buildup, and the jaw member with 150nm coating had little to no buildup or eschar of any kind. This indicates that while there is no difference in adhesion force for the coated jaw members, a reduction in accretion (e.g., eschar) is observed for higher thicknesses of coating. Thus, a non-stick coating according to the present disclosure is effective to prevent tissue adhesions when compared to an uncoated jaw member.

Example 2

This example compares jaw members having a non-stick coating formed from plasma polymerization of HMDSO in accordance with the present disclosure with jaw members of other vessel sealers.

For the present embodiment, LIGASURE will be described^TMIMPACT^TMThe six jaw members of the instrument are connected together with ENSEAL available from Epicocon Inc. (Ethicon Inc., Somerville, N.J.) of Morvel, N.J.^TMG2 Super Jaw Instrument and THUNDERBEAT available from Olympus, Center Valley, Pa., Central Valley, Pa., Inc. of Central Valley, Pa^TMThe Jaw members of the Open Extended Jaw instrument are used together. Three of the LIGASURE^TMIMPACT^TMThe jaw members were coated with a non-stick coating according to the present disclosure, and the remaining three instruments were not coated. Not modifying ENSEAL in any way^TMAnd THUNDERBEAT^TMEach of the above.

Each of these instruments is paired with a particular electrosurgical generator. VALLEYLAB available from Medtronic Inc^TMFT10、FORCETRIAD^TMAnd LS10 is connected to IMPACT^TMOne of a coated and an uncoated jaw member of an instrument, such that the coated and uncoated IMPACT^TMEach of the instruments is paired with a different generator. In addition, ENSEAL is added^TMThe instrument was coupled to an Ericsson G11 generator and used to couple THUNDERBEAT^TMThe instrument is coupled to the Olympus ESG-400 (electrosurgical) and USG-400 (ultrasound) generators due to THUNDERBEAT^TMThe instrument is a bimodal instrument.

The same force measurement station and tissue testing procedure was used to measure the adhesion force for each of a total of ten combined instrument/generator combinations. One hundred and ten (110) sealing cycles were performed using each of the combinations, i.e., ten (10) seals for eleven (11) rounds. Between each round approximately 15-35 minutes of interruption. The blocking force was measured and recorded within each of the sealing cycles.

The blocking evaluation involves a qualitative assessment by a laboratory technician while sealing. Generally, if tissue is not being dislodged from the jaw members, the jaw members will be opened and closed several times in an attempt to detach the tissue. After two or three open/close sequences, the tissue will be removed by graspers or manually. Tissue is considered non-adherent if it is removed from the jaw members, and adherent if it is stretched as it is pulled away from the jaw members.

For thunderbolt^TMIn the case of instruments, as they are ultrasonic devices (where tissue between jaw members is cut as part of a sealing cycle), adhesion assessment involves determining whether tissue adheres to a portion of a top jaw (e.g., a passive jaw). For ENSEAL^TMWith respect to the device, there are many different types of adhesions. The most common situation is when the jaw members become jammed and cannot spring back open after actuation. This requires manual intervention to pull the jaw members apart or to force the jaw handles open. There are many times when the jaws are openedTissue adheres to a portion of the bottom jaw member. IMPACT for all three generators^TMWith the instrument, adhesions are observed in the form of tissue adhering to a portion of the jaw member and not easily sloughed off. There is no case where the jaw members cannot be opened on these instruments.

A summary of the blocking results is shown in table 1 below. Table 1 includes the number of seals with and without blocking under the yes column and the percentage of seals classified as blocking. In Table 1, LF4418 refers to IMPACT coated^TMInstruments and LF4318 refers to IMPACT without coating^TMInstruments in which the suffix indicates the generator used (indicating forcetrad)^TMFT, FT10 or LS 10).

The results of the statistical analysis are summarized in table 2 below, and in addition to illustrating the results, the P-value for each comparison of interest is also illustrated. FORCETRIAD^TMCoated IMPACT tested on Generator^TMInstrument and thunderbolt^TMThe device had statistically fewer adhesions (P ═ 0.032), and ENSEAL^TMAnd in FORCETRIAD^TMUncoated IMPACT tested above^TMThe devices all had statistically more adhesions (both P)<0.001). Coated IMPACT tested on FT10 generator^TMThe instrument is compared with THUNDERBEAT^TMThe devices showed no statistical difference in adhesion rate (P ═ 0.099). ENSEAL^TMInstrument and uncoated IMPACT tested on FT10 generator^TMThe devices all had statistically more adhesions (P)<0.001). IMPACT tested on LS10 Generator^TMInstrument, THUNDERBEAT^TMInstrument (P0.005) and ENSEAL^TMInstrument (P)<0.001) and uncoated as tested on LS10 generatorsIMPACT of^TMInstrument (P)<0.001) all had statistically more adhesions.

IMPACT to be coated^TMAdhesion rate on instruments and uncoated IMPACT^TMInstrument, ENSEAL^TMInstrument and TUNDERBEAT^TMThe instruments are compared. When associated with any VALLEYLAB^TMIMPACT coated generator^TMWhen the instruments are compared, ENSEAL^TMThe device had statistically more adhesions. IMPACT to be coated^TMInstrument and uncoated IMPACT^TMComparison of the instruments (on their respective generator sets) yields a coated IMPACT^TMThe device as a whole had statistically fewer adhesions. When it is combined with FORCETRIAD^TMAnd coated IMPACT^TMTHUNDERBEAT when comparing combinations of instruments^TMThere was statistically less blocking. However, there were no statistical differences in blocking when compared to the FT10 generator, and thunderteam when compared to the LS10 generator^TMThe device had statistically more adhesions. Thus, the non-stick coating according to the present disclosure is effective in preventing tissue adhesions when compared to uncoated jaw members and other coated instruments. In addition, the effectiveness of the non-stick coating also depends on the type of generator used. Therefore, the power supply of the generator and/or its control algorithm is also a factor.