Hot cutting element, electrosurgical instrument comprising a hot cutting element, and manufacturing method

Abstract

A method of manufacturing a heat cutting element for a surgical instrument includes manufacturing a substrate, coating at least a portion of the substrate via plasma electrolytic oxidation (PEO), and disposing a heating element on at least a portion of the PEO-coated substrate. The method can further include attaching the heat cutting element to a jaw member of a surgical instrument. A heat cutting element for a jaw member of a surgical instrument includes a substrate, a PEO coating disposed on the substrate, and a heating element disposed on the PEO coating and including first and second end portions adapted to be connected to different electrical potentials to heat the heating element.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Applications Nos. 62 / 952,232 and 62 / 952,234, both filed on December 21, 2019, the entire contents of each of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to surgical instruments, and more specifically, to thermal cutting elements, electrosurgical instruments including thermal cutting elements, and methods of manufacturing thermal cutting elements. Background Technology

[0004] Surgical forceps are forceps-like instruments that rely on the mechanical action between their jaw members to grasp, clamp, and restrain tissue. Electrosurgical forceps utilize mechanical clamping and energy to heat tissue to treat, for example, coagulate, cauterize, or seal tissue. Typically, once the tissue has been treated, the surgeon must precisely remove the treated tissue. Therefore, many electrosurgical forceps are designed to include a blade that advances between the jaw members to cut the treated tissue. As an alternative to mechanical blades, energy-based tissue cutting elements can be provided to use energy (e.g., thermal, electrosurgical, ultrasonic, light, or other suitable energy) to cut the treated tissue. Summary of the Invention

[0005] As used herein, the term "distal" refers to the portion farther from the user, while the term "proximal" refers to the portion closer to the user. Furthermore, to a consistent degree, any or all aspects detailed herein may be used in conjunction with any or all other aspects detailed herein.

[0006] According to an aspect of this disclosure, a thermal cutting element for surgical instruments is provided. The thermal cutting element includes: a substrate; a PEO coating disposed on the substrate; and a heating element disposed on the PEO coating and including electrical energy adapted to be connected to different potentials to heat first and second end portions of the heating element.

[0007] In one aspect of this disclosure, the heating element defines a continuous circuit trace between the first and second end portions.

[0008] In another aspect of this disclosure, the first and second end portions of the heating element are arranged adjacent to each other.

[0009] In another aspect of this disclosure, first and second electrical contacts are disposed on respective first and second end portions of the heating element. The first and second electrical contacts are configured to facilitate the connection of electrical energy of different potentials to the first and second end portions, respectively.

[0010] In another aspect of this disclosure, the substrate is formed of aluminum, titanium, an aluminum alloy, or a titanium alloy.

[0011] In yet another aspect of this disclosure, the PEO coating is defined as having an average thickness of about 50 micrometers to about 150 micrometers; in other aspects about 75 micrometers to about 125 micrometers; and in other aspects about 100 micrometers.

[0012] In another aspect of this disclosure, a substrate defines an elongated body and a proximal connecting flange extending from the elongated body. First and second end portions of the heating element are disposed at the proximal connecting flange.

[0013] The jaw assembly of the surgical instrument according to this disclosure includes: a structural frame including a proximal flange portion and a distal body portion; a jaw housing surrounding the distal body portion of the structural frame; and a tissue processing plate disposed on top of the jaw housing. The tissue processing plate defines a longitudinal slot extending therethrough for at least a portion of its length. The jaw assembly further includes a thermal cutting element disposed within the jaw housing and extending through at least a portion of the longitudinal slot along at least a portion of the length of the tissue processing plate. The thermal cutting element may be configured similarly to any aspect detailed above or provided herein.

[0014] In various aspects, the tissue processing plate is formed of a conductive material and is adapted for connection to an electrosurgical energy source. In these aspects, the tissue processing plate is electrically isolated from the heating element.

[0015] In all aspects, the thermal cutting element includes an attachment flange extending from it into the jaw housing. The attachment flange facilitates the attachment of the thermal cutting element within the jaw housing.

[0016] A method for manufacturing a thermal cutting element for surgical instruments according to aspects of this disclosure includes: manufacturing a substrate; coating at least a portion of the substrate via plasma electrolytic oxidation (PEO); and disposing a heating element on at least a portion of the PEO-coated substrate.

[0017] In one aspect of this disclosure, placing a heating element includes forming continuous circuit traces on a PEO-coated substrate. The continuous circuit traces may extend between first and second end portions of the heating element. In another aspect, forming continuous circuit traces on a PEO-coated substrate includes forming a circuit trace pattern, wherein the first and second end portions of the circuit trace pattern are disposed adjacent to each other.

[0018] In another aspect of this disclosure, placing the heating element includes sputtering the heating element onto a PEO-coated substrate.

[0019] In another aspect of this disclosure, placing the heating element includes screen printing the heating element onto a PEO-coated substrate.

[0020] In another aspect of this disclosure, the method further includes placing first and second electrical contacts on respective first and second end portions of the heating element. The placement of the first and second electrical contacts can be accomplished via sputtering, screen printing, or other suitable methods.

[0021] In another aspect of this disclosure, manufacturing the substrate includes die-stamping the substrate. In various aspects, the substrate is one of a plurality of substrates progressively die-stamped from a carrier belt.

[0022] In another aspect of this disclosure, the method further includes placing an electrically insulating material on at least a portion of the heating element.

[0023] In various aspects of this disclosure, PEO is controlled such that the PEO coating is defined as having an average thickness of about 50 micrometers to about 150 micrometers; in other aspects about 75 micrometers to about 125 micrometers; and in still other aspects about 100 micrometers.

[0024] In another aspect of this disclosure, the method further includes attaching a PEO-coated substrate, on which a heating element is disposed, to a jaw member.

[0025] In various aspects, attaching a PEO-coated substrate with a heating element to a jaw member includes electrically connecting first and second end portions of the heating element to first and second electrical connectors, respectively, and / or mechanically connecting an attachment flange of the substrate to a jaw housing of the jaw member. The mechanical connection may include overmolding the jaw housing onto the attachment flange. Attached Figure Description

[0026] The above and other aspects and features of this disclosure will become more apparent when considered in conjunction with the accompanying drawings, in view of the following detailed description, wherein like reference numerals identify similar or identical elements.

[0027] Figure 1 This is a perspective view of an axis-based electrosurgical forceps provided in this disclosure, shown as connected to an electrosurgical generator;

[0028] Figure 2 This is a perspective view of a hemostat-type electrosurgical forceps provided in this disclosure;

[0029] Figure 3 This is a schematic diagram of a robotic surgical instrument provided in this disclosure;

[0030] Figure 4 yes Figure 1 A perspective view of the distal end portion of the clamps, wherein the first and second jaw members of the end effector assembly of the clamps are positioned at a spaced-apart locations.

[0031] Figure 5A yes Figure 4 A bottom perspective view of the first jaw member of the end effector assembly;

[0032] Figure 5B yes Figure 4 Top perspective view of the second jaw member of the end effector assembly;

[0033] Figures 6A-6C It is provided in accordance with this disclosure and configured for use with Figure 4 Partial side cross-sectional view of various configurations of a thermal cutting element used together with the second jaw member of the end effector assembly;

[0034] Figure 7 This is a flowchart illustrating a method for manufacturing a thermally cuttable element according to this disclosure;

[0035] Figure 8A This is a side view of another thermal cutting element provided in this disclosure;

[0036] Figure 8B It is shown Figure 8A A side view of a thermal cutting element applying heat to tissue during use; and

[0037] Figure 9 This is a partial perspective view of an end effector assembly provided in this disclosure, wherein the end effector assembly incorporates... Figure 8A Thermal cutting elements. Detailed Implementation

[0038] refer to Figure 1 The figure shows an axis-based electrosurgical forceps provided according to this disclosure, which is generally identified by reference numeral 10. Aspects and features of the forceps 10 that are not closely related to the understanding of this disclosure are omitted to avoid obscuring the aspects and features of this disclosure with unnecessary detail.

[0039] The clamp 10 includes a housing 20, a handle assembly 30, a trigger assembly 60, a rotary assembly 70, a first start switch 80, a second start switch 90, and an end effector assembly 100. The clamp 10 further includes a shaft 12 having a distal end portion 14 configured to directly or indirectly engage the end effector assembly 100 and a proximal end portion 16 of the housing 20. The clamp 10 also includes a cable "C" connecting the clamp 10 to an energy source (e.g., an electrosurgical generator "G"). The cable "C" includes wires (or multiple wires) (not shown) extending therethrough, having sufficient length to extend through the shaft 12 to connect to one or both tissue treatment surfaces 114, 124 of the jaw members 110, 120 of the end effector assembly 100 (see [link to relevant documentation]). Figure 4), to provide it with energy. The first start switch 80 is connected to the tissue processing surfaces 114, 124 ( Figure 4 ) and an electrosurgical generator "G", for selectively activating the energy supply to jaw members 110, 120 for procedures such as cauterization, coagulation / drying, and / or sealing of tissue. A second start switch 90 is connected to the thermal cutting element 130 of jaw member 120 ( Figure 4 ) and electrosurgical generator "G", which is used to selectively activate the energy supply to the thermal cutting element 150 for thermal cutting of tissue.

[0040] The handle assembly 30 of the clamp 10 includes a fixed handle 50 and a movable handle 40. The fixed handle 50 is integrally connected to the housing 20, and the handle 40 is movable relative to the fixed handle 50. The movable handle 40 of the handle assembly 30 is operatively coupled to a drive assembly (not shown) that, together with the other drive assembly, mechanically cooperates to move one or both of the jaw members 110, 120 of the end effector assembly 100 about a pivot 103 between spaced-out and proximal positions, thereby gripping tissue between the tissue-processing surfaces 114, 124 of the jaw members 110, 120. Figure 1 As shown, the movable handle 40 is initially spaced apart from the fixed handle 50, and correspondingly, the jaw members 110, 120 of the end effector assembly 100 are positioned at the spaced-apart locations. The movable handle 40 can be pressed from this initial position to a pressed position corresponding to the approach position of the jaw members 110, 120. The rotating assembly 70 includes a rotating wheel 72, which can be selectively rotated in either direction to rotate the end effector assembly 100 relative to the housing 20.

[0041] refer to Figure 2 The figure shows a hemostatic electrosurgical forceps provided according to this disclosure, which is generally identified by reference numeral 210. Aspects and features of the forceps 210 that are not closely related to the understanding of this disclosure are omitted to avoid obscuring the aspects and features of this disclosure in unnecessary detail.

[0042] The clamp 210 includes two elongated shaft members 212a and 212b, each elongated shaft member having a proximal end portion 216a and 216b and a distal end portion 214a and 214b, respectively. The clamp 210 is configured for use with an end effector assembly 100 (similar to an end effector assembly 100). Figure 4The end effector assembly 100' is used together with the shaft members 212a, 212b. More specifically, the end effector assembly 100' includes a first jaw member 110' and a second jaw member 120' attached to respective distal end portions 214a, 214b of the shaft members 212a, 212b. The jaw members 110', 120' are pivotally connected about a pivot 103'. Each shaft member 212a, 212b includes handles 217a, 217b disposed at its proximal end portion 216a, 216b. Each handle 217a, 217b defines finger holes 218a, 218b therethrough for receiving a user's finger. As can be understood, the finger holes 218a, 218b facilitate the movement of the shaft members 212a, 212b relative to each other, thereby pivoting the jaw members 110', 120' from a spaced-apart position to an approach position, in which the jaw members 110', 120' are positioned spaced apart relative to each other, and in the approach position, the jaw members 110', 120' cooperate to grasp tissue therebetween.

[0043] One of the shaft members 212a and 212b of clamp 210, such as shaft member 212b, includes a proximal shaft connector 219, which is configured to connect clamp 210 to an energy source, such as an electrosurgical generator "G" ( Figure 1 A proximal shaft connector 219 secures cable "C" to jaws 210, allowing the user to selectively supply energy to jaw members 110', 120' for tissue processing. More specifically, a first start switch 280 is provided to supply energy to jaw members 110', 120' for tissue processing when shaft members 212a, 212b are sufficiently close, for example, when the first start switch 280 is activated via shaft member 212a. A second start switch 290, disposed on one or both of shaft members 212a, 212b, is coupled to a thermal cutting element (not shown, similar to thermal cutting element 150 of jaw member 120) in one of the jaw members 110', 120' of the end effector assembly 100'. Figure 4 It is connected to the electrosurgical generator "G" to selectively activate the supply of energy to the thermal cutting element for thermal cutting of tissue.

[0044] Jaw members 110' and 120' define a bending configuration, wherein each jaw member is similarly laterally bent away from the longitudinal axis of the end effector assembly 100'. However, other suitable bending configurations are also considered, including bending toward one of the jaw members 110' and 120' (and thus away from the other), multiple bending with the same plane, and / or multiple bending in different planes. End effector assembly 100 ( Figure 1 The jaw components 110 and 120 can also be bent according to any configuration indicated above or in any other suitable manner.

[0045] refer to Figure 3 The accompanying drawing illustrates a robotic surgical instrument provided according to this disclosure, which is generally identified by reference numeral 1000. Aspects and features of the robotic surgical instrument 1000 that are not closely related to the understanding of this disclosure are omitted to avoid obscuring the aspects and features of this disclosure with unnecessary detail.

[0046] The robotic surgical instrument 1000 includes multiple robotic arms 1002, 1003; a control unit 1004; and an operation console 1005 connected to the control unit 1004. The operation console 1005 may include a display device 1006, which may be specifically configured to display three-dimensional images; and manual input devices 1007, 1008, through which the surgeon can remotely manipulate the robotic arms 1002, 1003 in a first operating mode. The robotic surgical instrument 1000 can be configured for use on a patient 1013 lying on a patient operating table 1012 for minimally invasive treatment. The robotic surgical instrument 1000 may also include a database 1014, specifically connected to the control unit 1004, which stores, for example, preoperative data and / or anatomical diagrams from the patient 1013.

[0047] Each of the robotic arms 1002 and 1003 may include multiple components connected by joints, and attachment devices 1009 and 1011, such as end effector assemblies 1100 and 1200, which may be attached to attachment devices 1009 and 1011, respectively. End effector assembly 1100 is similar to end effector assembly 100 (…). Figure 4 However, other suitable end effector assemblies for attachment to attachment device 1009 are also considered. End effector assembly 1200 can be any end effector assembly, such as an endoscopic camera, other surgical instruments, etc. Robotic arms 1002, 1003 and end effector assemblies 1100, 1200 can be driven by an electric actuator (e.g., a motor) connected to control device 1004. Control device 1004 (e.g., a computer) can be configured to specifically activate the motors by means of a computer program, such that robotic arms 1002, 1003, their attachment devices 1009, 1011, and end effector assemblies 1100, 1200 perform desired movements and / or functions according to corresponding inputs from manual input devices 1007, 1008, respectively. Control device 1004 can also be configured to regulate the movement of robotic arms 1002, 1003 and / or motors.

[0048] Go to Figure 4-5BAs noted above, the end effector assembly 100 includes a first jaw member 110 and a second jaw member 120. Each jaw member 110, 120 may include a structural frame 111, 121, a jaw housing 112, 122, and a tissue processing plate 113, 123 defining its respective tissue processing surface 114, 124. Alternatively, only one of the jaw members, such as jaw member 120, may include a structural frame 121, a jaw housing 122, and a tissue processing plate 123 defining the tissue processing surface 124. In such embodiments, other jaw members, such as jaw member 110, may be formed as a single unit, for example, a single piece of conductive material serving as the structural frame 111 and jaw housing 112 and defining the tissue processing surface 114. In such embodiments, the outer surface of the jaw housing 112 may be at least partially coated with an insulating material or may remain exposed. In embodiments, tissue processing plates 113, 123 may be deposited, for example, via sputtering onto jaw housings 112, 122 or jaw inserts (not shown) disposed within jaw housings 112, 122. Alternatively, tissue processing plates 113, 123 may be pre-formed and engaged with jaw housings 112, 122 and / or jaw inserts (not shown) disposed within jaw housings 112, 122 via, for example, overmolding, bonding, mechanical engagement, etc.

[0049] Special Reference Figure 4 and 5A As noted above, jaw member 110 can be configured similarly to jaw member 120, can be formed as a single unit, or can be formed in any other suitable manner to define structural frame 111 and tissue treatment surface 114 opposite to tissue treatment surface 124 of jaw member 120. Structural frame 111 includes proximal flange portion 116 about which jaw member 110 is pivotally coupled to jaw member 120. In axis-based or robot-based embodiments, proximal flange portion 116 may further include orifice 117a for receiving pivot 103 and at least one protrusion 117b extending therefrom, the protrusion 117b being configured to receive within the orifice in a drive sleeve defining a drive assembly (not shown), such that translation of the drive sleeve, for example in response to movable handle 40 ( Figure 1 The jaw member 110 is pivoted about pivot 103 and relative to jaw member 120 between spaced-out and approach positions by actuation or robot drive. However, other suitable drive arrangements are also considered, such as the use of cam pins and cam slots, screw drive mechanisms, etc.

[0050] Regardless of the specific configuration of the jaw member 110, the jaw member 110 may include a longitudinally extending insulating member 115 extending along at least a portion of the length of the tissue treatment surface 114. The insulating member 115 may be laterally centered on the tissue treatment surface 114 or may be offset relative to it. Furthermore, the insulating member 115 may be disposed (e.g., deposited, coated, etc.) on the tissue treatment surface 114, may be positioned within a channel or recess defined within the tissue treatment surface 114, or may define any other suitable configuration. Additionally, the insulating member 115 may be substantially coplanar with the tissue treatment surface 114 (within manufacturing, material, and / or usage tolerances), may protrude from the tissue treatment surface 114, may be recessed relative to the tissue treatment surface 114, or may include different portions that are coplanar with respect to the tissue treatment surface 114, protruding, and / or recessed. The insulating member 115 may be formed of, for example, ceramic, parylene, nylon, PTFE, or (one or more) other suitable materials (including combinations of insulating and non-insulating materials).

[0051] refer to Figure 4 and 5B As noted above, jaw member 120 may include a structural frame 121, a jaw housing 122, and a tissue processing plate 123 defining its tissue processing surface 124. Jaw member 120 further includes a thermal cutting element 130. Structural frame 121 defines a proximal flange portion 126 and a distal body portion (not shown) extending distally from the proximal flange portion 126. The proximal flange portion 126 is bifurcated to define a pair of spaced-apart proximal flange portion segments that receive the proximal flange 111 of jaw member 110 therebetween and define aligned orifices 127 configured to receive a pivot 103 passing through it to pivotally connect jaw members 110, 120 to each other.

[0052] The jaw housing 122 of the jaw member 120 is disposed around the distal main body portion of the structural frame 121, for example via overmolding, bonding, mechanical engagement, etc., and supports the tissue treatment plate 123 thereon, for example via overmolding, bonding, mechanical engagement, deposition (e.g., via sputtering), etc. As noted above, the tissue treatment plate 123 defines a tissue treatment surface 124. A longitudinally extending slot 125 is defined through the tissue treatment plate 123 and is positioned in proximity to the insulating member 115 of the jaw member 110 (…). Figure 5A The slot 125 may extend through at least a portion of the jaw housing 122, the jaw insert (if provided), and / or other parts of the jaw member 120, so that the thermal cutting element 130 can be received at least partially within the slot 125.

[0053] More specifically, the thermal cutting element 130 is disposed within the longitudinally extending slot 125 such that the thermal cutting element 130, in a proximity position, is in contact with the insulating member 115 of the jaw member 110. Figure 5A Relative. The thermal cutting element 130 can be configured to contact the insulating member 115 in a proximity position. Figure 5A This is to adjust or facilitate the adjustment of the gap distance between the tissue processing surfaces 114, 124 in the proximal position. Alternatively or additionally, one or more stop members (not shown) associated with jaw member 110 and / or jaw member 120 may be provided to adjust the gap distance between the tissue processing surfaces 114, 124 in the proximal position.

[0054] The thermal cutting element 130 may be surrounded by an insulating member 128 disposed within the slot 125 to electrically isolate the thermal cutting element from the tissue processing plate 123. Alternatively or additionally, the thermal cutting element 130 may include an insulating coating on at least its sides for similar purposes. The thermal cutting element 130 and the insulating member 128 may be substantially coplanar with the tissue processing surface 124 (within manufacturing, material, and / or usage tolerances), may protrude from the tissue processing surface 124, may be recessed relative to the tissue processing surface 124, or may include different portions that are coplanar with respect to the tissue processing surface 124, protruding, and / or recessed.

[0055] In embodiments where the end effector assembly 100 or a portion thereof is curved, the longitudinally extending slot 125 and the thermal cutting element 130 can similarly be curved, for example, wherein the longitudinally extending slot 125 and the thermal cutting element 130 (or their corresponding portions) are configured relative to an arc of curvature (or multiple arcs) rather than a longitudinal axis. Therefore, the terms longitudinal, transverse, etc., as used herein are not limited to straight configurations, such as along a straight axis, but equally apply to curved configurations, such as along an arc of curvature. In such curved configurations, the jaw member 110 ( Figure 5A The insulating component 115 is also bent.

[0056] General Reference Figure 1-5B The tissue processing plates 113 and 123 are formed of a conductive material, for example, for conducting electrical energy therebetween to process tissue. However, the tissue processing plates 113 and 123 can alternatively be configured to conduct any suitable energy, such as heat, microwaves, light, ultrasound, etc., through the tissue gripped therebetween for energy-based tissue processing. As mentioned above, the tissue processing plates 113 and 123 are connected to a start switch 80 and an electrosurgical generator "G" ( Figure 1This allows energy to be selectively supplied to and conducted between tissue processing plates 113, 123 and through tissue positioned between jaw members 110, 120 to process tissue, for example, to seal tissue on either side and extend across thermal cutting element 130.

[0057] On the other hand, the thermal cutting element 130 is configured to be connected to the electrosurgical generator "G" ( Figure 1 A second start switch 90 is provided to selectively activate the energy supply to the thermal cutting element 130 for heating the thermal cutting element 130 to thermally cut tissue disposed between the jaw members 110, 120, for example, cutting sealed tissue into first and second sealed tissue portions. Alternatively, other configurations including multi-mode switches, other individual switches, etc., may be provided.

[0058] refer to Figures 6A-6C The thermal cutting element 130 can be any suitable thermal cutting element, such as an aluminum substrate, at least a portion of which has undergone plasma electrolytic oxidation (PEO) treatment and is coated with a heating layer, such that when an AC voltage is applied, the thermal cutting element 130 is heated to thermally cut the tissue in contact with it. More specifically, the thermal cutting element 130 may include a substrate 1310, a PEO coating 1320 surrounding at least a portion of the outer surface of the substrate 1310, and a heating layer 1330 disposed on the PEO coating 1320. In embodiments, the thermal cutting element 130 may further include first and second electrical contacts 1340 disposed on the heating layer 1330 (in... Figure 6B and 6C Only one electrical contact is shown in the image, used to connect the first and second electrical leads 1350 to it (in...). Figures 6A-6C Only one electrical lead is shown in the diagram, but the electrical lead 1350 can alternatively be connected to the heating layer 1330 without using electrical contacts (see [link]). Figure 6A Alternatively, the thermal cutting element 130 may include an insulating layer 1360 disposed on a portion of the heating layer 1330 and / or the PEO coating 1320. Figure 6C In this embodiment, a ceramic substrate can be used as an alternative to a PEO-coated substrate.

[0059] Go to Figure 7 Combined with the test Figures 6A-6C The present invention describes in detail a method 900 for manufacturing a thermally cuttable element 130. Initially, in step 910, a substrate 1310 is manufactured. For the purposes of this document, the term "manufactured" includes obtaining the component from, for example, a third-party supplier or a supplier that manufactures the component. Furthermore, although the various steps of method 900 must be described sequentially below, to the extent feasible, the individual steps need not be performed in the order detailed below; the simultaneous performance of multiple steps is also contemplated.

[0060] Regarding the fabrication of substrate 1310 in step 910, substrate 1310 may be made of aluminum, titanium, alloys thereof, combinations thereof, or one or more other suitable materials suitable for PEO anodizing. In embodiments, multiple substrates 1310 are fabricated together, for example as progressive die stamping portions on a carrier strip. In other embodiments, each substrate 1310 may be fabricated individually, for example via machining, casting, forging, fine stamping, or any other suitable method. For simplicity, method 900 is described in detail below with respect to a single substrate 1310 and thermal cutting element 130, but it should be understood that method 900 can be similarly applied to multiple substrates 1310 to form multiple thermal cutting elements 130.

[0061] Proceed to step 920 to prepare substrate 1310. Preparing substrate 1310 may include degreasing and / or cleaning, for example, using any suitable method; deburring; edge trimming; and / or surface finishing, such as one or more of tumbling, sandblasting, chemical etching, electropolishing, etc.

[0062] Once the substrate 1310 is prepared, it undergoes PEO anodizing in step 930. More specifically, for PEO anodizing of the substrate 1310, it is used as the anode in an electrochemical bath. That is, the substrate 1310 is immersed in a cold electrolyte bath, the electrolyte being composed of, for example, a dilute alkaline solution containing sodium silicate or potassium silicate. The substrate 1310 is connected to an electrical energy source to define one electrode in the electrochemical bath, wherein a counter electrode made of an inert material, for example, stainless steel, is also electrically connected to the electrochemical bath, thereby forming, for example, the wall of the bath itself. For example, in one embodiment, a potential of more than 200 V and up to 700 V is applied between the two electrodes. The potential can be continuous or a pulsed direct current (DC) or alternating current (AC). The desired final thickness of the PEO coating 1320 can determine the specific voltage applied and / or the time the substrate 1310 remains in the bath.

[0063] Compared to standard anodizing, a higher voltage potential is applied for PEO anodizing. For example, in embodiments, such as PEO anodizing of aluminum, the voltage potential can be at least 200 V and at most 700 V. These high voltages exceed the dielectric breakdown potential of the growing oxide film and allow discharge. These discharges result in localized plasma reactions under high temperature and high pressure conditions, which alter the growing oxide, for example, through melting, melt flow, re-solidification, sintering, and / or densification. Specifically, the oxide is partially transformed from amorphous alumina into a crystalline form, such as corundum (α-Al₂O₃) with increased hardness.

[0064] Once the PEO anodizing of the substrate 1310 is completed in step 930 to form a PEO coating 1320 around at least a portion of the substrate 1310, the coated substrate can be washed with water. Alternatively, in embodiments, the coated substrate can be polished to eliminate or reduce surface roughness caused by the PEO process.

[0065] The PEO anodizing process in step 930 can be controlled such that the coating 1320 is defined as having an average thickness of about 50 micrometers to about 150 micrometers in one embodiment; about 75 micrometers to about 125 micrometers in another embodiment; about 90 micrometers to about 110 micrometers in yet another embodiment; and about 100 micrometers in still another embodiment. As used herein, “about” takes into account tolerances generally acceptable for a particular application in terms of materials, manufacturing, measurement, environment, and others, and may include variations of at least + / - 10%.

[0066] As detailed above, the PEO coating 1320 has an electrical insulation property of at least about 10 V / micrometer. Therefore, for a PEO coating 1320 with a thickness of about 100 micrometers, the PEO coating 1320 provides a dielectric barrier of at least 1000 V. This allows the PEO coating 1320 to withstand temperatures up to 1000°C, which is advantageous compared to standard anodizing, which cannot withstand temperatures above about 150°C without cracking.

[0067] Once the PEO coating 1320 has been formed around the substrate 1310 as detailed above, the heating layer 1330 can be attached to the PEO-coated substrate, as indicated in step 940. Attaching the heating layer 1330 can be accomplished via a deposition process such as sputtering, but other methods for attaching the heating layer 1330, such as screen printing, are also conceivable. These methods are advantageous because they allow attachment without requiring the substrate 1310 to be heated above its melting point. The heating layer 1330 can be formed from, for example, a nickel-chromium alloy, kanthal, platinum, combinations thereof, or one or more other suitable metals (e.g., positive thermal coefficient (PTC) resistance heating materials) that satisfy the desired heating and resistance characteristics.

[0068] More specifically, the sputtering process may include loading a coated substrate into a shadow mask holder and sputtering the heating layer 1330 onto the coated substrate to attach heating element circuitry to the PEO-coated substrate.

[0069] More specifically, the screen printing process may include loading a coated substrate into a screen printing fixture and screen printing the heating layer 1330 together with an adhesive onto the coated substrate. The result is then fired at approximately 850°C to approximately 1000°C to burn off the adhesive and sinter the heating layer 1330 onto the PEO-coated substrate, thereby attaching the heating element circuitry to the PEO-coated substrate.

[0070] In one embodiment, in step 950, an electrically insulating material is disposed around the heating layer 1330 to form an insulating layer 1360. The insulating layer 1360 may be silicon dioxide and / or sputtered onto the heating layer 1330 to provide protection against oxidation and / or fluid ingress, as well as electrical insulation. Alternatively, the insulating layer 1360 may be glass and / or screen-printed and fired onto the heating layer 1330 to provide protection against oxidation and / or fluid ingress, as well as electrical insulation. Other suitable materials and / or attachment methods are also considered.

[0071] As indicated in step 960, an electrical connection is established to the heating layer 1330. In one embodiment, an electrical contact 1340 is attached to the heating layer 1330 for connecting a corresponding electrical lead 1350 thereto. Alternatively, the electrical lead 1350 may be connected to the heating layer 1330 without using the electrical contact 1340.

[0072] In the provided embodiments, the electrical contact 1340 may be formed of a material suitable for facilitating electrical connection, such as nickel or copper. The electrical contact 1340 may be applied to the end portion of the heating element circuit via sputtering, for example using a second shadow mask holder. In embodiments, the electrical contact 1340 may be thickened using electroplating, for example, nickel or other suitable electroplatable metals. As an alternative to sputtering, the electrical contact 1340, in the form of an electrical contact pad, may be screen-printed and burned onto the end portion of the heating element circuit.

[0073] Electrical lead 1350 is connected directly or indirectly to electrical contact 1340 or the end portion of the heating element circuit via sputtering (in embodiments where electrical contact 1340 is not provided). Electrical lead 1350 may use, for example, spring clip 2370 (see...). Figure 9 Mechanical connectors or other suitable attachment methods such as resistance welding, laser welding, ball welding, electroplating, brazing, soldering, and the use of conductive adhesives can be used for connection.

[0074] As indicated in step 970, the formed thermal cutting element 130 can ultimately be integrated, attached, or otherwise combined with, for example, end effector assemblies 100, 2100 (respectively). Figure 4 and 9 In the surgical end effector assembly. Otherwise, or afterward, the method ends at 980.

[0075] refer to Figure 8A and 8B And first refer to Figure 8A An embodiment of the thermal cutting element 230 according to the present disclosure is shown, for example, which utilizes the method 900 detailed above. Figure 7 The thermal cutting element 230 is manufactured or manufactured in any other suitable manner. The thermal cutting element 230 includes: a substrate 2310; a PEO coating 2320 disposed around the substrate 2310; a heating layer 2330 disposed on the PEO coating 2320 to form a heating element circuit, which includes a first end portion 2331 and a second end portion 2332; and first and second contacts 2340 electrically connected to corresponding first end portions 2331 and second end portions 2332 of the heating layer 2330. The thermal cutting element 230 defines an elongated body 232, a proximal connecting flange 234 extending from a proximal end portion of the elongated body 232, and one or more attachment flanges 236 extending from, for example, from a central or distal end portion of the elongated body 232. The first end portion 2331 and the second end portion 2332 of the heating layer 2330 are disposed at the proximal connecting flange 234. The heating layer 2330 defines a continuous circuit trace, which includes first and second spaced-apart sections extending distally from the first end portion 2331 and the second end portion 2332 along the elongated body 232 to or adjacent to the distal end portion of the elongated body 232, respectively, wherein the first and second sections are interconnected via connector sections of the heating layer 2330.

[0076] The first and second contacts 2340 are respectively attached to a first portion 2331 and a second end portion 2332 of the heating layer 2330 at the proximal connecting flange 234, so that electrical leads can be connected thereto for applying AC voltage to heat the thermal cutting element 230. In one embodiment, the proximal connecting flange 234 extends orthogonally to the longitudinal axis of the elongated body 232, but other configurations are also considered.

[0077] The attachment flange 236 defines an orifice 237, which is configured to facilitate engagement of the thermal cutting element 230 with a jaw member, such as jaw member 2120. Figure 9 (or other suitable components of a surgical end effector assembly.) In one embodiment, the attachment flange 236 extends orthogonally to the longitudinal axis of the elongated body 232, but other configurations are also considered.

[0078] Figure 8BA thermal cutting element 230 in use is shown, wherein tissue "T" is in contact with the thermal cutting element 230 and an AC voltage is applied across the first and second contacts 2340, thereby heating the thermal cutting element 230. Directional arrows indicate the thermal gradient, thus, due to the configuration of the thermal cutting element 230, heat is conducted from the portions of the thermal cutting element 230 that are not in contact with the tissue "T" to those portions that are in contact with the tissue "T". This facilitates heating and control of the temperature of the portions of the thermal cutting element 230 in contact with the tissue "T", thereby facilitating controlled cutting of the tissue "T".

[0079] Go to Figure 9 The thermal cutting element 230 is shown. Figure 8A and 8B ) combined with a component similar to an end effector assembly 100 ( Figure 4 The end effector assembly 2100 generally includes a first jaw member 2110 and a second jaw member 2120, at least one of which is movable relative to the other between a spaced-out position and a proximal position. Each jaw member 2110, 2120 includes structural frames 2111, 2121, jaw housings 2112, 2122, and tissue processing plates 2113, 2123 defining tissue processing surfaces 2114, 2124. The end effector assembly 2100 may further include the end effector assembly 100 as detailed above. Figure 4 It has any of the characteristics of [the other entity] and can operate in a similar way. Therefore, for the sake of brevity, only the differences will be described in detail below.

[0080] The jaw member 2120 includes first and second spring clips 2370 disposed therein and first and second electrical leads 2350 connected to the respective first and second spring clips 2370. A thermal cutting element 230 is seated within a longitudinally extending slot 2125 defined within the jaw member 2120, such that the respective first and second spring clips 2370 engage with a proximal connecting flange 234 and are biased to maintain electrical contact with an electrical contact 2340, thereby electrically connecting the electrical leads 2350 to a heating layer 2330. An elongated body 232 of the thermal cutting element 230 extends longitudinally along the jaw member 210 and is positioned flush with, recessed relative to, or protruding from the tissue processing surface 2124. The elongated body 232 may terminate before the distal end of the tissue processing plate 2123 and / or the jaw member 2120, may extend to the distal end of the tissue processing plate 2123 and / or the jaw member 2120, or may extend beyond the distal end of the tissue processing plate 2123 and / or the jaw member 2120.

[0081] The thermal cutting element 230 can be secured within the jaw member 2120 via an internal jaw insert (not shown) and / or a jaw housing 2122 overmolded around the structural frame 2121. Regarding the overmolded jaw housing 2122 (or internal jaw insert), the orifice 237 of the attachment flange 236 allows the overmolded material to flow through, facilitating a secure engagement. The engagement of the proximal connecting flange 234 with the spring clip 2370 further facilitates the mechanical securing of the thermal cutting element 230 in place.

[0082] While several embodiments of this disclosure have been shown in the accompanying drawings, this is not intended to limit the disclosure thereto, as it is intended to make the scope of the disclosure as broad as is permitted in the art, and the specification should be read in the same manner. Therefore, the foregoing description should not be construed as limiting, but merely as illustrative of particular embodiments. Those skilled in the art will contemplate other modifications within the scope and spirit of the appended claims.

Claims

1. A method for manufacturing a thermal cutting element for surgical instruments, the method comprising: Manufacturing substrates; At least a portion of the substrate is coated via plasma electrolytic oxidation (PEO); and The heating element is disposed on at least a portion of a substrate coated with plasma electrolytic oxidation, wherein disposing of the heating element includes sputtering the heating element onto the substrate coated with plasma electrolytic oxidation.

2. The method of claim 1, wherein placing the heating element includes forming a continuous circuit trace on the plasma-electrolytically oxidized substrate, the continuous circuit trace extending between a first end portion and a second end portion of the heating element.

3. The method of claim 2, wherein forming the continuous circuit traces on the plasma electrolytic oxidation coated substrate comprises forming a circuit trace pattern, wherein a first end portion and a second end portion of the circuit trace pattern are disposed adjacent to each other.

4. The method of claim 1, wherein placing the heating element comprises screen printing the heating element onto the plasma electrolytic oxidation coated substrate.

5. The method of claim 1, further comprising: The first electrical contact and the second electrical contact are disposed on the corresponding first end portion and second end portion of the heating element.

6. The method of claim 5, wherein placing the first electrical contact and the second electrical contact comprises sputtering the first electrical contact and the second electrical contact onto the respective first end portion and the second end portion of the heating element.

7. The method of claim 5, wherein placing the first electrical contact and the second electrical contact comprises screen printing the first electrical contact and the second electrical contact onto the respective first end portion and the second end portion of the heating element.

8. The method of claim 1, wherein manufacturing the substrate includes die-stamping the substrate.

9. The method of claim 8, wherein the substrate is one of a plurality of substrates progressively die-stamped from a carrier belt.

10. The method of claim 1, further comprising placing an electrically insulating material on at least a portion of the heating element.

11. The method of claim 1, wherein the plasma electrolytic oxidation is controlled such that the plasma electrolytic oxidation coating has an average thickness of 50 micrometers to 150 micrometers.

12. The method of claim 1, wherein the plasma electrolytic oxidation is controlled such that the plasma electrolytic oxidation coating has an average thickness of 75 micrometers to 125 micrometers.

13. The method of claim 1, wherein the plasma electrolytic oxidation is controlled such that the plasma electrolytic oxidation coating has an average thickness of about 100 micrometers.

14. The method of claim 1, further comprising: A substrate with a heating element and a plasma electrolytic oxidation coating is attached to a jaw member.

15. The method of claim 14, wherein the attachment comprises: The first and second end portions of the heating element are electrically connected to the first and second electrical connectors, respectively.

16. The method of claim 14, wherein the attachment comprises: The attachment flange of the substrate is mechanically connected to the jaw housing of the jaw member.

17. The method of claim 16, wherein mechanical coupling comprises overmolding the jaw housing onto the attachment flange.

18. A thermal cutting element for surgical instruments, comprising: substrate; Plasma electrolytic oxidation (PEO) coating, which is disposed on the substrate; and A heating element sputtered onto the plasma electrolytic oxidation coating, the heating element comprising a first end portion and a second end portion adapted to be connected to electrical energy at different potentials to heat the heating element.

19. The thermal cutting element of claim 18, wherein the heating element defines a continuous circuit trace between the first end portion and the second end portion.

20. The thermal cutting element of claim 19, wherein the first end portion and the second end portion of the heating element are disposed adjacent to each other.

21. The thermal cutting element of claim 18, further comprising a first electrical contact and a second electrical contact disposed on respective first end portions and second end portions of the heating element, the first electrical contact and the second electrical contact being configured to facilitate the connection of electrical energy of the different potentials to the first end portions and the second end portions.

22. The thermal cutting element of claim 18, wherein the substrate is formed of aluminum, titanium, aluminum alloy or titanium alloy.

23. The thermal cutting element of claim 18, wherein the plasma electrolytic oxidation coating has an average thickness of 50 micrometers to 150 micrometers.

24. The thermal cutting element of claim 18, wherein the plasma electrolytic oxidation coating has an average thickness of 75 micrometers to 125 micrometers.

25. The thermal cutting element of claim 18, wherein the plasma electrolytic oxidation coating defines an average thickness of about 100 micrometers.

26. The thermal cutting element of claim 18, wherein the substrate defines an elongated body and a proximal connecting flange extending from the elongated body, and the first end portion and the second end portion of the heating element are disposed at the proximal connecting flange.

27. A jaw component of a surgical instrument, comprising: The structural frame includes a proximal flange section and a distal main body section; Jaw housing that surrounds the distal main body portion of the structural frame; A tissue processing plate is disposed on top of the jaw housing, the tissue processing plate defining a longitudinal slot extending therethrough at least a portion of its length; and The thermal cutting element of claim 18, wherein the thermal cutting element is disposed within the jaw housing and extends through at least a portion of the longitudinal slot along at least a portion of the length of the tissue processing plate.

28. The jaw member of claim 27, wherein the tissue processing plate is formed of a conductive material and adapted to be connected to an electrosurgical energy source, the tissue processing plate being electrically isolated from the heating element.

29. The jaw assembly of claim 27, wherein the thermal cutting element further includes an attachment flange extending therefrom into the jaw housing, the attachment flange facilitating attachment of the thermal cutting element within the jaw housing.

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