1. Technical Field
The present disclosure relates to the field of surgical instruments. More particularly, the disclosure relates to methods of manufacturing jaw members of an end-effector assembly for a surgical instrument.
2. Discussion of Related Art
Bipolar electrosurgical forceps have an end-effector assembly with electrodes on the inner, opposing surfaces of pivotally movable jaw members. The electrodes are electrically coupled to an electrosurgical generator, with the electrode on one jaw member actively delivering electrosurgical energy and the electrode on the other jaw member functioning as a return, thereby creating an electrical circuit through tissue grasped by the jaw members.
Tissue grasped by the jaw members can be treated to different degrees (e.g., cauterized, coagulated, desiccated, sealed, or divided) depending on the intensity, frequency and duration of the electrosurgical energy applied by the electrodes. The effectiveness of the electrosurgical energy on the tissue is affected by mechanical factors such as the pressure applied to the tissue when grasped by the jaw members and the gap distance between the electrically-conductive tissue-contacting surfaces (electrodes) of the jaw members.
Predictability in such mechanical factors can be provided by meeting specific tolerance requirements when manufacturing the end-effector assembly of the electrosurgical forceps. It would be desirable to develop manufacturing methods for end-effector assemblies to meet tolerance requirements such as gap tolerances, alignment of the jaw members and the like. It would be desirable to develop manufacturing methods for jaw members to ensure the reliability of stop members for controlling the gap distance between the electrically-conductive tissue-contacting surfaces of the jaw members when closed about tissue.
Jaw members that meet design tolerance requirements and ensure the reliability of stop members for controlling the gap distance are provided by the manufacturing processes described herein.
According to an aspect of the present disclosure, a method of manufacturing a jaw member of an end-effector assembly is provided and includes forming one or more stress-relief cavities within a sealing plate. Each one of the one or more stress-relief cavities defines a pad portion of an electrically-conductive surface of the sealing plate. The method also includes forming a stop member on each pad portion of the electrically-conductive surface of the sealing plate, performing an overmolding operation, wherein the one or more stress-relief cavities is configured to prevent force applied to a bottom surface of the sealing plate during the overmolding operation from stressing the pad portion to avoid compromising adhesion between the stop member and the electrically-conductive surface of the sealing plate.
According to another aspect of the present disclosure, a method of manufacturing a jaw member of an end-effector assembly is provided and includes forming at least one stress-relief cavity within a sealing plate. Each one of the at least one stress-relief cavities defines a pad portion of an electrically-conductive surface of the sealing plate. The method also includes: depositing a material on each pad portion for forming a stop member thereon, each one of the at least one stress-relief cavities functioning as a wetting ring to limit the spread of the material; and utilizing each one of the at least one stress-relief cavities to prevent force applied to a bottom surface of the sealing plate during an overmolding operation from stressing each pad portion to avoid compromising adhesion between the stop member and the electrically-conductive surface of the sealing plate.
In any one of the preceding aspects, forming one or more stress-relief cavities may include forming a first portion of each of the one or more stress-relief cavities configured to facilitate the formation of a stop member having a circle-like shape or oval-like shape.
In any one of the preceding aspects, forming one or more stress-relief cavities includes forming a second portion of each of the one or more stress-relief cavities configured to prevent stress from external forces applied to the sealing plate from compromising adhesion between the stop member and the sealing plate.
Objects and features of the end-effector assemblies for use in surgical instruments and methods of manufacturing jaw members of an end-effector assembly of the present disclosure will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:
Hereinafter, embodiments of end-effector assemblies for use in surgical instruments and methods of manufacturing jaw members of an end-effector assembly of the present disclosure are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the apparatus, or component thereof, closer to the user and the term “distal” refers to that portion of the apparatus, or component thereof, farther from the user.
This description may use the phrases “in an embodiment,” “in embodiments,” “in some embodiments,” or “in other embodiments,” which may each refer to one or more of the same or different embodiments in accordance with the present disclosure.
As it is used in this description, “electrically-conductive tissue-contacting plate” generally refers to an electrically-conductive member including one or more tissue engaging surfaces that can be used to transfer energy from an electrosurgical power generating source, such as RF electrosurgical generator, to tissue. As it is used in this description, “electrically conductive”, or simply “conductive”, generally refers to materials that are capable of electrical conductivity, including, without limitation, materials that are highly conductive, e.g., metals and alloys, or materials that are semi-conductive, e.g., semi-conducting materials and composites.
Vessel sealing or tissue sealing utilizes a combination of radiofrequency energy, pressure and gap control to effectively seal or fuse tissue between two opposing jaw members or sealing plates thereof. Vessel or tissue sealing is more than “cauterization” which may be defined as the use of heat to destroy tissue (also called “diathermy” or “electrodiathermy”), and vessel sealing is more than “coagulation” which may be defined as a process of desiccating tissue wherein the tissue cells are ruptured and dried. As it is used in this description, “vessel sealing” generally refers to the process of liquefying the collagen, elastin and ground substances in the tissue so that it reforms into a fused mass with significantly-reduced demarcation between the opposing tissue structures.
Various embodiments of the present disclosure provide end-effector assemblies for use in surgical instruments, e.g., surgical forceps, suitable for sealing, cauterizing, coagulating/desiccating and/or cutting vessels and vascular tissue. Various embodiments of the present disclosure provide methods of manufacturing jaw members of an end-effector assembly. Embodiments of the presently-disclosed methods of manufacturing jaw members include forming one or more stress-relief cavities within one or both of the electrically-conductive tissue-engaging surfaces of the opposing pair of jaw members.
In
As shown in
Forceps 10 generally includes an elongated shaft 12 that defines a longitudinal axis “A-A”, and supports the end-effector assembly 100. Shaft 12 extends from the housing 20 and supports movement of other components therethrough, e.g., to impart movement to the jaw members 110 and 120. End-effector assembly 100 is rotatable about the longitudinal axis “A-A” through rotation, either manually or otherwise, of the rotatable assembly 80. As shown in
As shown in
As can be appreciated, applying force to move the movable handle 40 toward the fixed handle 50 pulls a drive sleeve or drive rod (not shown) proximally to impart movement to the jaw members 110 and 120 from an open position, wherein the jaw members 110 and 120 are disposed in spaced relation relative to one another, to a clamping or closed position, wherein the jaw members 110 and 120 cooperate to grasp tissue therebetween. Trigger assembly 70 is operable to extend and retract a knife blade through the end-effector assembly 100 when the end-effector assembly 100 is in the closed configuration.
Forceps 10 includes a cable 15, which is in electrical communication with at least one of the jaw members 110 and 120 such that electrosurgical energy, e.g., supplied by a power generating source 28, may be delivered to tissue clamped in the end-effector assembly 100. Cable 15 may be internally divided into one or more cable leads each of which transmits energy through its respective feed path to the end-effector assembly 100. Power generating source 28 may be any generator suitable for use with surgical devices, and may be configured to operate in a variety of modes. Forceps 10 may alternatively be configured as a wireless device or battery-powered.
Sealing plates 112 and 122, as shown in
In some embodiments, the end-effector assembly 100 may include a structural support member (not shown) associated with each of the jaw members 110 and 120 and configured to support the sealing plates 112 and 122. Support structures may be formed from any suitable material or combination of materials, e.g., metallic material, plastic and the like, and may be formed by any suitable process, e.g., machining, stamping, electrical discharge machining (EDM), forging, casting, injection molding, metal injection molding (MIM), and/or fineblanking. Examples of metallic material that may be suitable include aluminum and alloys thereof, plated brass, stainless steel, stainless steel alloys, beryllium copper, etc. End-effector assembly 100 may include electrically-insulative members and/or electrically-insulative, thermally non-degrading coatings configured to electrically isolate, at least in part, the sealing plates 112 and 122 from the structural support members.
In some embodiments, as shown for example in
Stop members 90 may be configured to facilitate and/or enhance the gripping and manipulation of tissue and to control the gap distance between the electrically-conductive sealing plates 112 and 122 of the jaw members 110 and 120, respectively, when closed about tissue, e.g., during the sealing and cutting of tissue. In some embodiments, to provide an effective tissue seal, an appropriate gap distance of about 0.001 inches to about 0.010 inches and, desirably, between about 0.002 inches to about 0.005 inches, may be provided. Stop members 90 of varied configurations may be disposed on or adjacent to one or both of the sealing plates 112 and 122 and/or operatively associated with one or both jaw members 110 and 120, e.g., depending upon a particular purpose or to achieve a desired result.
In some embodiments, the sealing plates 112 and 122 may be at least partially encapsulated by outer insulative housings (e.g., outer housing 111 and 121 shown in
Stress-relief cavities 160 of varied configurations may be associated with one or both of the sealing plates 112 and 122. In some embodiments, as shown for example in
In accordance with a method of manufacturing jaw members of the present disclosure, in an initial step, as shown in
Stress-relief cavities 160 are configured to facilitate the formation of the stop members 90 and configured to prevent stress from external forces applied to the seal plate from compromising the adhesion of the stop members 90 during an overmolding operation, e.g., overmolding of an outer insulative housing of a jaw member. An illustrative embodiment of an overmolding operation performed on a sealing plate configured with a stress-relief cavity (e.g., stress-relief cavity 660 shown in
As shown in
In some embodiments, the stop members 90 are constructed of a heat-resistant ceramic deposited onto one or both of the sealing plates 112 and 122. Stop members 90 may define any suitable number, arrangement, and/or configuration, to achieve a desired gap distance, e.g., depending on a particular purpose. In some embodiments, upon depositing a ceramic (or any other suitable material) onto the sealing plate 122 to form a plurality of stop members 90, the stress-relief cavities 160 function as wetting rings to provide shape uniformity among the plurality of stop members 90.
Stress-relief cavity 560 includes a first portion 561 having any suitable height “H3” and any suitable width “W2”. As shown in
Because of the high pressures utilized during overmolding of jaw members, force applied to the bottom surface 529 of the sealing plate 522 can result in bending and/or deflection the tissue-engaging surface 523 of the sealing plate 522. Stress-relief cavity 560 includes a second portion 562 having any suitable height “H3”+“H4” and configured to prevent stress from external forces applied to the sealing plate 522 (e.g., during an overmolding operation) from compromising the adhesion between the stop member 90 and the sealing plate 522.
In accordance with an embodiment of the present disclosure, the bottom of the second portion 562 provides a stress-relief point “P1” that is offset from the pad portion 524 of the sealing plate 522. The configuration of the stress-relief point “P1” shown in
Stress-relief cavity 660 is defined by a first wall 661, a second wall 662, and a third wall 663. The first wall 661 of the stress-relief cavity 660 defines a pad portion 624 of the sealing plate 622. Pad portion 624 is configured to facilitate the formation of a stop member 90 in a particular shape, e.g., a circle-like shape. Pad portion 624 may have any suitable diameter “D3”.
The second wall 662 of the stress-relief cavity 660 may have any suitable height “H5”. As shown in
In
First tool member 550 includes a cavity 558 having any suitable height “H6”. A material 565 is disposed within a portion of the cavity 558, wherein the material includes a surface 567 that is offset by a suitable height “H7” from the surface 553 of the first tool member 550. The height “H7” may be set to minimize the risk of any contact between the stop member 90 and the material 565 upon deflection of the sealing plate during the overmolding process. Material 565 may be any material having suitable material characteristics. In some embodiments, the material 565 may be sufficiently resilient to absorb impact with the stop member 90 upon deflection of the sealing plate, e.g., to prevent cracking or otherwise damaging the stop member 90.
In accordance with an embodiment of the present disclosure, compatible with any of the sealing plate embodiments disclosed herein, a method of manufacturing a pair of opposing jaw members 110 and 120 of an end-effector assembly 100 includes forming one or more stress-relief cavities (e.g., stress-relief cavity 560) within a sealing plate (e.g., sealing plate 522). Each of the one or more stress-relief cavities 560 defines a pad portion 524 of an electrically-conductive surface 523 of the sealing plate 522. The method also includes forming a stop member 90 on each pad portion 524 of the electrically-conductive surface 523 of the sealing plate 522, performing an overmolding operation, and utilizing the one or more stress-relief cavities 560 to prevent force applied to a bottom surface 529 of the sealing plate 522 during the overmolding operation from stressing each pad portion 524 to avoid compromising adhesion between the stop member 90 and the electrically-conductive surface 523 of the sealing plate 522.
In a slight variation of
The above-described end-effector assembly embodiments including any combination of features of the above-described sealing plates may utilize jaw member components of varied geometries, e.g., lengths and curvatures, such that variously-configured jaw members may be fabricated and assembled into various end-effector configurations, e.g., depending upon design of specialized surgical instruments.
The above-described surgical instrument embodiments may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the surgeon in the operating theater and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include, remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely controls the instruments via the robotic surgical system. As can be appreciated, a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.
The robotic arms of the surgical system are typically coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the embodiments described herein. The movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon. The scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).
The master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions. The master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.
Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the disclosed processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 62/041,871, filed on Aug. 26, 2014, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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62041871 | Aug 2014 | US |