Insulated grasping portion for minimally invasive surgical instruments

By using insulating overmolded parts and ratchet mechanisms in minimally invasive surgical instruments to electrically isolate the internal metal frame, the problems of long sterilization time of the instrument and the safety hazards of electrical contact are solved, and rapid disinfection and safe reuse are achieved.

CN114945340BActive Publication Date: 2025-07-04MICROLINE SURGICAL INC
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Patent Information

Application Number
CN202080093153.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2020-11-16
Filing Date
2020-11-23
Publication Date
2025-07-04
Estimated Expiration
2040-11-23

AI Technical Summary

Technical Problem

Existing minimally invasive surgical devices consume a long time and consume a lot of resources during the sterilization process. Electrical contact between metal components may lead to current leakage, which poses safety hazards.

Method used

The metal parts of the internal metal frame are electrically isolated by insulating overmolded parts, mechanically coupled by insulating materials, limiting the conductivity between the components, and using a ratchet mechanism to limit the direction of movement when necessary, ensuring safety and reusability.

Benefits of technology

It realizes rapid disinfection and reuse of equipment, reduces sterilization time and resource consumption, improves usage safety, and avoids the safety risks brought by electrical contact between metal parts.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed is a surgical instrument having an insulating grasping portion. The grasping portion may include an internal metal frame that is configured to limit electrical conductivity within the grasping portion and on other components (such as a ratchet) attached to the grasping portion. The internal metal frame may be composed of a plurality of internal portions that are spatially separated from each other to interrupt electrical conductivity between the internal portions, but are coated with an insulating overmold to provide a mechanical connection between the portions. The internal metal frame may also include notches, cuts, or other areas partially surrounded by the structural portions of the internal metal frame, which areas may be coated with an insulating overmold to define an area within the grasping portion that does not have the internal metal frame but may include attachment points for mechanically connecting other components while limiting the electrical connection between the metal frame and the other components.
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Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Patent Application 17 / 099415, filed on November 16, 2020, and U.S. Provisional Application No. 62 / 961012, filed on January 14, 2020, the entire contents of both applications are incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to surgical devices, and more particularly to minimally invasive surgical instruments having insulated grasping portions, such as laparoscopic probes. Background Art

[0004] Minimally invasive surgical techniques may include inserting instruments through existing openings or small incisions into body cavities for surgical intervention. Surgical instruments used in such techniques may be remotely manipulated, such as by robotic control or manual control. For example, in endoscopic or laparoscopic surgery, an individual may use a handle or grasping portion connected to a surgical instrument through a control shaft that enters the patient's body to manipulate the surgical instrument within the patient's body. Thus, compared to traditional surgery, surgical intervention can be performed with less patient trauma, shorter healing times, and lower infection risks.

[0005] Typically, minimally invasive surgical techniques involve the use of electrosurgical instruments. Electrosurgical instruments use the application of an electric current to perform various surgical tasks, such as cutting, coagulating, drying, or electrocauterizing tissue. The electric current can flow through the control shaft and into the tissue surrounding the end effector of the surgical instrument.

[0006] Many minimally invasive surgical instruments are made as single-use instruments. Thus, each instrument is manufactured as a sterile instrument that is not expected to be or cannot be resterilized after use and is discarded.

[0007] Some minimally invasive surgical instruments are designed to have a reusable handle to which different shafts can be attached. Each shaft can have a different type of end effector, such as scissors or a grasper. The end effector can also be used as an electrocautery tool, although this is not necessary for all embodiments. In some cases, the entire shaft can be removed and sterilized. In some cases, the handle can also be sterilized. However, due to the length of the shafts used in various minimally invasive surgeries, sterilization of these tools can be burdensome, such as requiring custom or oversized sterilization bags or occupying such a large volume in an autoclave that it may be necessary to autoclave a single set of instruments in multiple batches. Thus, currently sterilizable minimally invasive surgical instruments may take a long time to sterilize and may require multiple batches of energy and resources.

[0008] Some components of the minimally invasive surgical instrument are made of metal and other components are made of insulating materials. Depending on the component, using metal or insulating material may be preferred and in some cases, using one material or the other may be inappropriate. In some cases, metal components in the minimally invasive surgical instrument are intentionally in contact with each other to allow current to be transferred from the electrical port to the electrosurgical tool. In some cases, metal components that are not intended to receive current may come into contact with other metal components and become charged when in contact with the user or patient, and inadvertently release current to the user or patient. Summary of the Invention

[0009] The terms "example" and like terms are intended to refer broadly to all subject matter of the present disclosure and the following claims. Statements containing these terms should be understood not to limit the subject matter described herein or to limit the meaning or scope of the following claims. The embodiments of the present disclosure covered herein are defined by the following claims rather than this summary. This summary is a high-level overview of various aspects of the present disclosure and introduces some concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to the appropriate portions of the entire specification of the present disclosure, any or all of the drawings, and each claim.

[0010] In one aspect, the present disclosure provides a device such as a minimally invasive surgical device. Exemplary devices of this aspect include a handle having an electrical port for receiving voltage or current and transmitting the voltage or current to a surgical tip; a first grasping portion mechanically coupled to the handle and having a first internal metal frame and a first insulating overmold located on the first internal metal frame, the first internal metal frame including a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion by the first insulating overmold; and a second grasping portion mechanically coupled to the handle and having a second internal metal frame and a second insulating overmold located on the second internal metal frame. Optionally, the handle may be coupled to the surgical tip to transfer motion from at least one of the first grasping portion and the second grasping portion to actuate the surgical tip. Optionally, one or more of the first internal metal portion or the second internal metal frame are electrically coupled to the electrical port.

[0011] In some examples, the first grasping portion is fixedly coupled to the handle. Optionally, the second grasping portion may be movably coupled to the handle. In some examples, the first grasping portion and the handle include an integral structure. Optionally, the handle itself includes an insulating handle overmold configured to provide an outer surface that is electrically insulated from the electrical port.

[0012] A ratchet or ratchet mechanism can be used with the device in this aspect. For example, the device in this aspect can optionally further include a ratchet that couples a first grasping portion and a second grasping portion to limit relative movement between the first grasping portion and the second grasping portion in one direction. Optionally, the ratchet is electrically isolated from the first internal metal portion or the second internal metal frame. Optionally, the ratchet includes a first ratchet portion coupled to the first grasping portion and a second ratchet portion coupled to the second grasping portion. Optionally, the first ratchet portion and the second ratchet portion slidably engage with each other to limit relative movement between the first grasping portion and the second grasping portion in this direction. Optionally, the ratchet further includes a release member for disengaging the first ratchet portion and the second ratchet portion. Optionally, the second ratchet portion is coupled to the second grasping portion by a fastener, such as a fastener that is coupled to a second insulating overmold and electrically isolated from the second internal metal frame. In some examples, the second internal metal frame includes a notch. For example, the second ratchet portion is optionally coupled to the second insulating overmold by a fastener such that the fastener passes through the notch without contacting the second internal metal frame.

[0013] As used herein, a notch (also referred to as a cutout) can correspond to a void, depression, or other structure of an object that is partially surrounded by a body portion of the object. A notch as used herein differs from a through-hole in that a notch is not completely surrounded by the body of the object, while a through-hole is completely surrounded by the body of the object. In a grasping portion of a surgical device, a notch can be created within an internal metal frame and the notch can be coated with another material (such as an insulating overmold) to define an area within the handle where there is no internal metal frame but where the coated material can be included as the main body of the grasping portion at that location. Such a grasping portion can optionally include connection points, such as through-holes, located within the insulating overmold for mechanically connecting other components, such as using fasteners, while limiting contact between the internal metal frame, the fasteners, or other components, which can provide an electrical connection between these elements.

[0014] Various materials can be used for the different elements of the device in this aspect. For example, the ratchet can optionally include metal, a thermoplastic polymer, or a combination thereof. Optionally, one or more of the first internal metal frame, the first internal metal portion, the second internal metal portion, or the second internal metal frame independently includes steel, stainless steel, surgical stainless steel, aluminum, or titanium. Optionally, one or more of the first insulating overmold or the second insulating overmold independently includes a thermoplastic polymer, such as polyetheretherketone or polysulfone.

[0015] Insulating materials prevent metal components of the device in this aspect from being in electrical contact with each other or with the user or patient. In other words, the insulating materials can provide electrical isolation between certain metal components of the device and can also provide electrical isolation between the metal components and the user or patient. In some examples, one or more of the first insulating overmold or the second insulating overmold can independently exhibit a dielectric strength of 130 kV / cm to 250 kV / cm. Optionally, one or more of the first insulating overmold or the second insulating overmold are made of autoclaveable and / or disinfectable materials.

[0016] In another aspect, methods are described herein. Example methods of this aspect include providing a surgical tip and a handpiece; coupling the surgical tip to the handpiece, the handpiece including: a handle having an electrical port for receiving voltage or current and transmitting the voltage or current to the surgical tip; a first grip mechanically coupled to the handle and having a first internal metal frame and a first insulating overmold located on the first internal metal frame, the first internal metal frame including a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion through the first insulating overmold; and a second grip mechanically coupled to the handle and having a second internal metal frame and a second insulating overmold located on the second internal metal frame; decoupling the surgical tip from the handpiece; and autoclaving or disinfecting the handpiece or the surgical tip or both. Optionally, the handle can be coupled to the surgical tip to transfer motion from at least one of the first grip and the second grip to actuate the surgical tip. Optionally, one or more of the first internal metal portion or the second internal metal frame are electrically coupled to the electrical port. Optionally, the surgical tip includes scissors, a grasper, a punch, or a dissector. These or other surgical tips can optionally be used as electrosurgical tools. Optionally, the handpiece includes any device, such as the minimally invasive surgical device described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] This specification refers to the following drawings, wherein like reference numerals in different drawings are intended to illustrate the same or similar components.

[0018] Figure 1 is a schematic side view of a surgical instrument including a surgical tip mounted on a handpiece, depicting certain aspects of the present disclosure.

[0019] Figure 2A is a schematic side view of a grip of the surgical instrument, showing an insulating overmold according to certain aspects of the present disclosure.

[0020] Figure 2B is a schematic side view of a grasping portion of a surgical instrument, showing an internal metal frame in accordance with certain aspects of the present disclosure.

[0021] Figure 2C is a schematic side view of a grasping portion of a surgical instrument, showing the position of an internal metal frame within an insulating overmold in accordance with certain aspects of the present disclosure.

[0022] Figure 3 is a schematic side view of a grasping portion of a surgical instrument and an enlarged schematic view of an exemplary ratchet in accordance with certain aspects of the present disclosure.

[0023] Figure 4 is a flow chart providing an overview of a process of using a surgical instrument in accordance with certain aspects of the present disclosure. DETAILED DESCRIPTION

[0024] Certain aspects of the present invention relate to surgical instruments for minimally invasive surgery. These surgical instruments can be configured for any suitable type of surgical procedure, such as robot-guided or robot-assisted surgery, endoscopic surgery, laparoscopic surgery, or any other suitable minimally invasive surgical procedure. In some cases, certain aspects of the present disclosure are particularly beneficial for laparoscopic surgical instruments due to the types of surgical instruments used in laparoscopic surgery. Aspects of the disclosed surgical instruments can include metal, which can provide rigidity, strength, and / or conductivity, while other aspects of the disclosed surgical instruments can include insulating materials, which can limit the flow of current from metal components to metal components.

[0025] A minimally invasive surgical instrument can include a surgical tip removably attached to a handle via a control shaft. The handle can optionally be non-removably coupled to the control shaft, although this need not always be the case. The combination of the handle and the control shaft, whether the control shaft is removable or not, can be referred to as a handpiece. The surgical tip is removably connected to the control shaft, allowing the surgical tip to be cleaned and sterilized. Additionally, by removing one surgical tip and attaching a different surgical tip, the function of the surgical instrument can be quickly changed in a hurry, such as during a surgical procedure. In this way, during a surgical procedure, a single handle and control shaft can be used with multiple surgical tips, such that only a single set of handle and control shaft needs to be cleaned and sterilized, although multiple different surgical tips are used with the same handle and control shaft. As used herein, a surgical instrument can be said to have a handle at its proximal end and a surgical tip at its distal end. Thus, the terms "distal" and "proximal" as used herein can refer to directions away from and toward the handle end of the surgical instrument.

[0026] The surgical tip can utilize any suitable type of end effector. Suitable types of end effectors include scissors, graspers, punches, and dissectors. For example, suitable scissors configurations can include curved scissors, straight scissors, Metzenbaum-type scissors, hooked scissors, etc. As an example, suitable grasper configurations can include non-invasive graspers, fenestrated graspers, clamping graspers, Babcock-type graspers, Hunter-type graspers, Allis-type graspers, etc. For example, suitable punches can include cup-shaped punches, biopsy punches, etc. For example, suitable dissectors can include dolphin-nose-type dissectors, Maryland-type dissectors, Birkett-grasper-type dissectors, etc.

[0027] The end effector can include one or more movable parts. In some cases, the end effector can move between a first and a second position by moving a single movable part against a fixed part, such as in a common biopsy punch. In the example of a biopsy punch, the movable part (e.g., the blade) can be pressed against the fixed part (e.g., the biopsy collection surface) to collect a biopsy. This type of action with a single movable part can be referred to as a single-action, and an end effector using this type of action can be referred to as a single-action end effector. In some cases, the end effector can have two movable parts, typically opposite each other, such as in a common pair of scissors. In the example of scissors, the two movable parts (e.g., the scissor blades) can move towards each other to initiate a cutting action. This type of action with two movable parts can be referred to as a double-action, and an end effector using this type of action can be referred to as a double-action end effector. However, in some cases, scissors can have a fixed blade and a movable blade. Aspects of the present invention can be used with single-acting or double-acting end effectors. In some cases, aspects of the present invention can be used with non-acting end effectors that do not have movable parts (e.g., electrosurgical electrodes).

[0028] The handle may include one or more grasping portions for actuating the end effector of the surgical tip through the movement of the one or more grasping portions. In some cases, one grasping portion may be locked in place or be in a fixed position or be integrally formed with the handle, while another grasping portion may have a variable position to actuate the end effector, although this is not necessarily always the case. The handle may be constructed in different ways depending on the desired function. Some grasping portions may have a ratcheting action while others do not. In some cases, the handle may include one or more electrical ports or posts (such as cautery posts) to transmit voltage and / or current to the control shaft and the end effector. Some handles may have short electrical posts while others have long electrical posts. In some cases, the handle may include a flush port to facilitate cleaning of the handle and / or the attached control shaft. In some cases, the electrical port may double as a flush port. In some cases, a rotary knob may control the rotation of the control shaft, which in turn may control the rotation of the end effector of the surgical tip.

[0029] In some cases, the various components may be permanently attached to each other, although this is not necessarily always the case. The components may include a plurality of internal components that may move relative to each other to engage and allow the translation of one or more grasping portions to actuate the movement of the components of the end effector. For example, the control shaft may include an outer shaft and an inner shaft. The inner shaft may move within the outer shaft, such as axially, to actuate the end effector by manipulating the inner shaft relative to the outer shaft. The inner shaft may be mechanically coupled to, for example, a variable grasping portion such that the movement of the variable grasping portion is translated into the movement of the inner shaft.

[0030] The different components of the surgical instrument may be made of different materials depending on their location, their likelihood of contacting the patient during surgery, their mechanical requirements, whether they need to be conductive or electrically insulating, etc. For reusability, it is desirable to manufacture the components of the surgical instrument from materials that can withstand the sterilization process (such as the pressure, temperature, and conditions generated within an autoclave). Exemplary materials compatible with the sterilization procedure include, but are not limited to, metals and thermoplastic polymers such as polyetheretherketone (PEEK) or polyetherimide (PEI) or polyphenylsulfone.

[0031] The structures and materials used in surgical devices can be used to limit or control the electrical conductivity between various components and improve reliability and safety. For example, a component such as a handle may include a metal coated in an electrically insulating material such as PEEK or PEI. In some cases, these components may directly include an electrically insulating material having embedded metal or other structures to allow interaction with other components (such as electrical ports or irrigation ports, control shafts, grasping portions, etc.). As another example, the outer shaft can be made of or coated with an electrically insulating material, such as PEEK or PEI. The inner shaft can be made of a conductive material, such as metal. In some cases, the inner shaft can be made of the same material as the elements or components of the surgical tip.

[0032] In some cases, components of a surgical instrument may benefit from the structural stiffness, material strength, and wear resistance provided by metal. However, since metal components are conductive, it is beneficial to at least partially coat them with an electrically insulating material if it is useful to limit the exposure of conductive surfaces. However, in some cases, it may be impractical or undesirable to manufacture certain components using an insulating material.

[0033] In some examples, a ratchet can include a gear or rack having one or more teeth and a spring-loaded pawl that engages recesses between or behind the teeth, thereby enabling easy movement in one direction and preventing movement in the opposite direction. The ratchet may include a release member or otherwise be movable to allow the pawl and teeth to disengage, thereby resetting or adjusting the position in the forward and backward directions. Optionally, the ratchet can automatically engage the release member or disengage the pawl and teeth at the maximum relative travel position of the grasping portion. The teeth, pawl, and release member are optionally made of metal, such as steel, to increase strength and reliability, but this is not required. Optionally, one or more of the teeth and the pawl can be made of metal because these components move relative to each other and may be subject to wear or stress for which non-metallic components (such as an insulating material like PEEK) may be inappropriate.

[0034] In some cases, components of a surgical device may come into contact with a user or patient during a surgical procedure, potentially exposing the user or patient to conductive surfaces in an undesired manner. Thus, it is advantageous to control whether and to what extent components come into contact with other conductive structures. For example, the structure of the grasping portion of a surgical instrument can be configured to limit the electrical conductivity between various components and enhance safety. For example, the grasping portion can include or incorporate an electrically insulating material, such as PEEK, optionally overmolded on an internal frame that can include or incorporate a metallic portion. In some cases, metal is included as the frame of the grasping portion for strength and rigidity and is optionally joined or mechanically coupled to a handle, control shaft, and / or ratchet, which are optionally made of metal.

[0035] The internal frame of the grasping portion can be made of multiple metallic portions that are spaced apart from each other to break the electrical path between the metallic portions. Insulating material can be used to mechanically couple the multiple portions together while still providing electrical isolation between the portions. For example, two internal metallic portions of the internal frame of the grasping portion can be overmolded with insulating material to mechanically connect the internal metallic portions and provide electrical isolation between them.

[0036] In some cases, the location of the internal metallic frame of the grasping portion where a pin or other fastener mechanically couples another component (such as a ratchet) to the grasping portion can include a notch or cutout overmolded with insulating material such that the pin or other fastener only mechanically couples to the insulating material and cannot contact the internal metallic frame.

[0037] Examples of insulating materials include thermoplastic polymers such as polyetheretherketone (PEEK) or polyphenylsulfone. Such polymers enable the grasping portion to resist damage due to inadvertent contact with other tools and surfaces, and these polymers are also able to withstand sterilization procedures. In the case where the surgical device is a single-use device only, the insulating material may not have to undergo the disinfection process, and thus other materials such as acetal, polypropylene, polycarbonate, polyethylene, polyvinylidene fluoride, polyester, or other medical-grade plastics can be used.

[0038] The insulating material can have a dielectric strength that is high enough. In some cases, the dielectric strength of the insulator can be or greater than about 230 kV / cm, for example, it can be or greater than about 130 kV / cm, 135 kV / cm, 140 kV / cm, 145 kV / cm, 150 kV / cm, 155 kV / cm, 160 kV / cm, 165 kV / cm, 170 kV / cm, 175 kV / cm, 180 kV / cm, 185 kV / cm, 190 kV / cm, 195 kV / cm, 200 kV / cm, 205 kV / cm, 210 kV / cm, 215 kV / cm, 225 kV / cm, 230 kV / cm, 235 kV / cm, 240 kV / cm, 245 kV / cm, and / or 250 kV / cm.

[0039] Useful insulating materials include those that comprise a thermoplastic polymer, which are suitable for surgical tools and are sterilizable and / or autoclaveable. Available insulating materials include those with a glass transition temperature of 121 °C to 300 °C (e.g., equal to or higher than 140 °C, 143 °C, or 288 °C). In some cases, the insulating material can have a melting temperature of 300 °C to 350 °C (e.g., equal to or higher than 340 °C or 343 °C). A sufficiently high glass transition temperature and / or melting temperature can ensure that the insulating material does not lose its shape or integrity when subjected to a sterilization procedure in an autoclave, which can reach temperatures up to 121 °C (e.g., for gravity-based autoclaves) or 135 °C (e.g., for vacuum-based autoclaves). In some cases, the insulating material can have a glass transition temperature higher than the maximum temperature of the disinfection procedure used for disinfecting surgical tips. Such a disinfection procedure can be a disinfection procedure shared with other devices commonly used with surgical tips, such as a scalpel for making incisions, the scalpel for making incisions of the surgical tip.

[0040] Aspects and features of the present disclosure enable minimally invasive surgical devices to be easily and effectively stored, safe and easy to use, have well-insulated surgical tips, handles, and other parts, be easily and effectively disinfected, and be highly customizable.

[0041] These illustrative examples are given to introduce the general subject matter discussed herein to the reader and are not intended to limit the scope of the disclosed concepts. The following sections describe various additional features and examples with reference to the accompanying drawings, in which like reference numerals represent like elements, and the directional descriptions are for describing illustrative embodiments but, like the illustrative embodiments, should not be used to limit the present disclosure. The elements included in the illustrations herein may not be drawn to scale.

[0042] Figure 1FIG. 0 is a schematic side view of a minimally invasive surgical instrument 100 including a surgical tip 102 mounted on a control shaft 104 coupled to a handle 120, in accordance with certain aspects of the present disclosure. The surgical tip 102 is removably coupled to the control shaft 104. In some cases, the control shaft 104 may be removably coupled to the handle 120, although this need not be the case. In some cases, the control shaft 104 is permanently coupled to the handle 120.

[0043] The surgical tip 102 may include a multi-component hub including a distal hub 112 and a proximal hub 114. The surgical tip 102 may be removably coupled to the control shaft 104 via the proximal hub 114, which in turn is permanently coupled to the distal hub 112, which is movably fixed to the end effector 106. The proximal hub 114 may optionally include one or more sets of threads to allow a secure but removable mechanical coupling between corresponding threads on the proximal hub 114 and the control shaft 104. Additional details of the coupling of the surgical tip 102 and the actuation of the end effector 106 can be found, for example, in U.S. Patent Application No. 16 / 298,817, filed on Mar. 11, 2019, which is incorporated herein by reference in its entirety.

[0044] The handle 120 is attached to a fixed grip 122 and a variable grip 144 for manipulating the end effector 106 of the surgical tip 102. Movement of the variable grip 124 can cause the inner shaft of the control shaft 104 to move axially relative to the outer shaft, thereby actuating the end effector (e.g., moving between a first position and a second position), optionally via a mechanical coupling to one or more intermediate elements. In some cases, the manipulation of the variable grip 124 may be further controlled by a ratchet mechanism 130, although this need not always be the case. The ratchet mechanism 130 may be located outside the handle 120, although this need not always be the case, and the ratchet mechanism 130 may optionally be located inside the handle 120. In some cases, the handle 120 may include a knob 150. The knob 150 can be operated to control the rotation of the control shaft 104, and thus the rotation of the surgical tip 102.

[0045] In some cases, the handle 120 may include a port 140. The port 140 may be used as one or both of an electrical port and a flush port. When used as an electrical port, the port 140 may transmit an electrical current to the inner shaft of the control shaft 104, which in turn may transmit the electrical current to the end effector 106 of the surgical tip 302, optionally via electrical coupling to one or more intervening elements. This electrical current may be used for various electrosurgical techniques, including cauterization. When used as a flush port, the port 140 may allow fluid to flush through the control shaft 104 to facilitate cleaning and / or disinfection of the control shaft 104. In some cases, such as when the control shaft 104 is permanently coupled to the handle 120, the use of the flush port may be particularly useful. In some cases, the handle 120 may include any number of ports 140, each of which may be used as one or more of an electrical port and a flush port.

[0046] Figures 2A - 2C are a set of schematic side views depicting a handle of a surgical instrument. In Figure 2A therein, grasping portions 200 and 210 are depicted, which represent first and second grasping portions of a surgical instrument (such as Figure 1 the minimally invasive surgical instrument 100 depicted in Figure 1 ). The grasping portions 200 and 210 may optionally correspond respectively to Figure 1 the grasping portions 122 and 124 of Figure 2A . The grasping portion 200 may correspond to a fixed grasping portion, meaning that it is or may be coupled to the handle of the surgical instrument in such a way that the grasping portion 200 does not move relative to the handle. The grasping portion 210 may correspond to a variable grasping portion, meaning that it may be coupled to the handle of the surgical instrument in such a way that the grasping portion 200 may move relative to the handle. Alternatively, the grasping portion 200 may be a variable grasping portion, the grasping portion 210 may be a fixed grasping portion, or both the grasping portions 200 and 210 may be variable grasping portions. The grasping portions 200 and 202 may respectively include openings 204 and 206 to provide positions for a user to insert fingers and / or grasp the grasping portions 200 and 202 during use. Optionally, the grasping portions 200 and 202 may not include any openings for the user's fingers. In Figure 2A therein, an insulating overmold is schematically depicted as covering the surfaces of the grasping portions 200 and 210.

[0047] Figure 2B Internal metal frames 220 and 230 are schematically shown, which respectively correspond to the internal metal structures of the grasping portions 200 and 210. Figure 2C The positions of the internal metal frames 220 and 230 within the insulating overmolds of the grasping portions 200 and 210 are schematically shown.

[0048] However, the internal metal frames 220 and 230 may have shapes that do not precisely match the shapes of the gripping portions 200 and 210 and may include additional features different from the gripping portions 200 and 210. For example, the internal metal frame 220 is composed of a plurality of internal metal parts, such as internal metal part 222 and internal metal part 224 separated by a gap 226, and the gap 226 may provide electrical isolation between the internal metal part 222 and the internal metal part 224. These separated internal metal parts 222 and 224 may be mechanically coupled to each other via an insulating overmolding that fills the gap 226 and coats the internal metal parts 222 and 224 with an integral coating material. Additionally, the internal metal frame 220 may include teeth 228 that may extend above the surface of the internal metal part 224 and are used to engage a ratchet mechanism or be part of a ratchet mechanism to limit the translation of the gripping portion 200 or 210 during use. Depending on the specific structure of the gripping portion 200, the teeth 228 may or may not be coated by the insulating overmolding. Additionally, the internal metal frame 220 may optionally include an area 229 that extends beyond the scope of the insulating overmolding, such as for mechanically coupling the internal metal frame 220 to other components, such as the handle of a surgical device.

[0049] As another example, the internal metal frame 230 may include incisions, depressions, notches, or other features 232 that correspond to areas of the internal metal frame 230 where there is no metallic material but is overmolded with an insulating material, as Figure 2C shown. An opening 234 may be present within the insulating overmolding at the location of the feature 232, which may be used to attach a pin or other fastener to allow another component to be attached to the gripping portion 210, such as a ratchet mechanism or a part thereof, without making electrical contact with the internal metal frame 230. Additionally, the internal metal frame 230 may optionally include an area 236 that extends beyond the scope of the insulating overmolding, such as for mechanically coupling the internal metal frame 230 to other components, such as the handle or control shaft of a surgical device or a part thereof.

[0050] Figure 3 A side schematic view of the gripping portions 300 and 310 and the disassembled ratchet 330 is provided. The ratchet 330 may optionally correspond to, for example, Figure 1 the ratchet mechanism 130 depicted in Figure 2A and 2C shown. The gripping portions 300 and 310 may optionally correspond to, for example, Figure 2BThe internal metal frames 220 and 230 shown. The ratchet 330 may include multiple components, such as a bottom 332 including a pawl 333 and a cover 334. The teeth 328 may enter the bottom 332 and engage the pawl 333 to limit the amount and / or direction of relative translation between the grasping portions 300 and 310. By using an internal metal frame in the grasping portion 300 including multiple internal metal portions that are electrically isolated from each other, such as Figure 2B the internal metal frame 220 depicted in, the teeth 328 may be electrically isolated from the components of the surgical device handle, and thus the pawl 333 may also be electrically isolated from the components of the surgical device handle, regardless of contact with the teeth 328.

[0051] The cover 334 may include a release member 336 that allows the pawl 333 and the teeth 328 to disengage from each other to allow the relative translation between the grasping portions 300 and 310 to be at least partially unrestricted. A pin 338 or other fastener may be used to attach the ratchet 330 to the grasping portion 310, such as by passing through an opening 314 in the grasping portion 310 and an opening 340 in the bottom 332 while being fixed to the cover 334. Attaching the ratchet 330 to the grasping portion 310 at the opening 314 may allow the ratchet 330 to be mechanically coupled to the grasping portion 310, and if the opening 314 is located at a notch, recess, incision, or other area within the grasping portion 310 where there is no internal metal frame, then the ratchet 330 remains electrically isolated from the internal metal frame within the grasping portion 310. Even if the internal metal frame is electrically connected to the components of the surgical device handle, this configuration may further allow the ratchet 330 to be electrically isolated from the components of the surgical device handle.

[0052] The above description and Figure 3 the manner of attaching the ratchet 330 to the grasping portions 300 and 310 shown is merely an example, and it can be understood that other structures can also be used. In some cases, the ratchet 330 may be removably attached to the handle 310 to allow the ratchet 330 to be replaced when worn.

[0053] Figure 4 is a flowchart depicting a process 400 of using a surgical instrument according to certain aspects of the present disclosure. At block 402, a surgical tip and a handpiece may be provided. The surgical tip can be any suitable surgical tip, such as Figure 1 the surgical tip 102 of. The handpiece can be any suitable handpiece, such as including Figure 1 the handle 120 and the control shaft 104 of. The surgical tip and the handpiece may be in a sterilized state and suitable for a surgical procedure. In some cases, the surgical tip may be provided by a kit of multiple surgical tips, each surgical tip having a different end effector. In some cases, providing the surgical tip may include providing a sterilized surgical tip in a sterilization bag.

[0054] At block 404, the surgical tip can be coupled to the handpiece. The handpiece can include a control shaft coupled (e.g., permanently or removably) to a handle. The surgical tip can be removably coupled to the handpiece. In some cases, coupling the surgical tip to the handpiece can include screwing a yoke of the surgical tip onto an inner shaft of the handpiece. In some cases, coupling the surgical tip to the handpiece can include screwing a proximal hub of the surgical tip onto an outer shaft of the handpiece. In some cases, coupling the surgical tip to the handpiece can include screwing a yoke of the surgical tip onto an inner shaft of the handpiece and screwing a proximal hub of the surgical tip onto an outer shaft of the handpiece.

[0055] At block 406, a surgical procedure can be performed using the surgical tip. In some cases, performing the surgical procedure can include passing an electric current through tissue adjacent to the surgical tip. In some cases, passing an electric current through tissue adjacent to the surgical tip can include passing an electric current through target tissue adjacent to an end effector of the surgical tip without applying the electric current to non-target tissue adjacent to a proximal hub of the surgical tip. In some cases, performing the surgical procedure can include actuating an end effector of the surgical tip within a patient by translating one or more grasping portions of the handpiece or connected to the handpiece. In some cases, performing the surgical procedure can include actuating an end effector of the surgical tip to close one or more movable portions of the end effector around tissue. In some cases, performing the surgical procedure can include actuating a ratchet to limit or translate one or more grasping portions of the handpiece or connected to the handpiece. In some cases, performing the surgical procedure can include releasing the ratchet, thereby enabling translation of one or more grasping portions of the handpiece or connected to the handpiece.

[0056] At block 408, the surgical tip can be removed from the handpiece. Removing the surgical tip from the handpiece can be opposite to coupling the surgical tip to the handpiece at block 404, e.g., unscrewing the surgical tip from the handpiece.

[0057] At block 410, the surgical tip or the handpiece or both can be sterilized. In some cases, sterilizing the surgical tip or the handpiece can include cleaning and disinfecting the surgical tip or the handpiece. In some cases, sterilizing the surgical tip or the handpiece can include autoclaving the surgical tip or the handpiece. In some cases, sterilizing the surgical tip or the handpiece can include subjecting the surgical tip or the handpiece to a temperature equal to or higher than 121 °C or 135 °C. In some cases, sterilizing the surgical tip or the handpiece can include placing the surgical tip or the handpiece in a sterilization pouch.

[0058] After being sterilized, the surgical tip or the handpiece can be reused, for example, by coupling to each other or to another surgical tip or handpiece. Coupling the surgical tip to the handpiece can be performed repeatedly at block 404 as part of an additional surgical procedure different from the surgical procedure associated with the above-mentioned surgery. For example, a first surgical procedure can be performed on a first patient, and a repeated surgical procedure associated with the surgery can be performed on a second patient.

[0059] In some cases, after block 410, if the surgical tip or the handpiece is considered to have undergone too many use and sterilization cycles (e.g., blocks 404, 406, 408, 410) such that the surgical tip or the handpiece is no longer acceptable for use, then one or both of the surgical tip or the handpiece can be discarded or refurbished.

[0060] As used below, any reference to a series of examples should be understood as a separate reference to each of those examples (e.g., "Examples 1-4" should be understood as "Examples 1, 2, 3, or 4").

[0061] Example 1 is a device that includes: a handle having an electrical port for receiving a voltage or current and transmitting the voltage or current to a surgical tip; a first gripper mechanically coupled to the handle and including or consisting of a first internal metal frame and a first insulating overmold located on the first internal metal frame, the first internal metal frame including or consisting of a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion by the first insulating overmold; and a second gripper mechanically coupled to the handle and having a second internal metal frame and a second insulating overmold located on the second internal metal frame; wherein the handle is couplable to the surgical tip to transmit motion from at least one of the first gripper and the second gripper to actuate the surgical tip, and wherein one or more of the first internal metal portion or the second internal metal frame are electrically coupled to the electrical port.

[0062] Example 2 is the device of Example 1, wherein the first gripper is fixedly coupled to the handle, and wherein the second gripper is movably coupled to the handle.

[0063] Embodiment 3 is the device of Embodiment 2, wherein the first gripper and the handle include an integral structure.

[0064] Example 4 is the device of Examples 1-3, wherein the handle includes an insulating handle overmold configured to provide an outer surface that is electrically insulated from the electrical port.

[0065] Example 5 is the device described in Examples 1 - 4, wherein the device further includes a ratchet that couples the first gripping portion and the second gripping portion to limit relative movement between the first gripping portion and the second gripping portion in one direction.

[0066] Example 6 is the device described in Example 5, wherein the ratchet is electrically isolated from the first internal metal portion or the second internal metal frame.

[0067] Example 7 is the device described in Examples 5 - 6, wherein the ratchet includes a first ratchet portion coupled to the first gripping portion and a second ratchet portion coupled to the second gripping portion, wherein the first ratchet portion and the second ratchet portion are slidably engaged with each other to limit relative movement between the first gripping portion and the second gripping portion in the direction.

[0068] Example 8 is the device according to Example 7, wherein the second ratchet portion is coupled to the second gripping portion by a fastener, wherein the fastener is coupled to the second insulation overmolding and is electrically isolated from the second internal metal frame.

[0069] Example 9 is the device described in Examples 7 - 8, wherein the second internal metal frame includes a notch, wherein the second ratchet portion is coupled to the second insulation overmolding by a fastener such that the fastener passes through the notch without contacting the second internal metal frame.

[0070] Example 10 is the device described in Examples 7 - 9, wherein the ratchet further includes a release member for disengaging the first ratchet portion from the second ratchet portion.

[0071] Example 11 is the device described in Examples 5 - 10, wherein the ratchet includes metal, a thermoplastic polymer, or a combination thereof.

[0072] Example 12 is the device described in Examples 1 - 11, wherein one or more of the first internal metal frame, the first internal metal portion, the second internal metal portion, or the second internal metal frame independently includes steel, stainless steel, surgical stainless steel, aluminum, or titanium.

[0073] Example 13 is the device described in Examples 1 - 12, wherein one or more of the first insulation overmolding or the second insulation overmolding independently includes a thermoplastic polymer, polyetheretherketone, or polysulfone.

[0074] Example 14 is the device described in Examples 1-13, wherein one or more of the first insulation overmolding or the second insulation overmolding independently exhibit a dielectric strength of 130 kV / cm to 250 kV / cm.

[0075] Example 15 is the device described in Examples 1-14, wherein one or more of the first insulation overmolding or the second insulation overmolding are made of a material that is autoclaveable and / or disinfectable.

[0076] Example 16 is the device described in Examples 1-15, wherein the device further includes a control shaft coupled to the handle.

[0077] Example 17 is the surgical device described in Example 16, wherein the control shaft is removably coupled to the handle.

[0078] Example 18 is the device described in Examples 16-17, wherein the surgical tip is removably coupled to the control shaft.

[0079] Example 19 is a method that includes: providing a surgical tip and a handpiece; coupling the surgical tip to the handpiece, the handpiece including: a handle having an electrical port for receiving voltage or current and transmitting the voltage or current to the surgical tip; a first gripping portion mechanically coupled to the handle and having a first internal metal frame and a first insulation overmolding located on the first internal metal frame, the first internal metal frame including a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion through the first insulation overmolding; and a second gripping portion mechanically coupled to the handle and having a second internal metal frame and a second insulation overmolding located on the second internal metal frame; wherein the handle is couplable to the surgical tip to transmit motion from at least one of the first gripping portion and the second gripping portion to actuate the surgical tip, and wherein one or more of the first internal metal portion or the second internal metal frame are electrically coupled to the electrical port; decoupling the surgical tip from the handpiece; and autoclaving the handpiece.

[0080] Example 20 is the method described in Example 19, wherein the surgical tip includes an electrocautery tool, scissors, a grasper, a punch, and / or a dissector.

[0081] Example 21 is the method described in Examples 19-20, wherein the handpiece includes the device according to any one of Examples 1-18.

[0082] The foregoing description of the embodiments and examples, including the illustrated embodiments and examples, is given only for purposes of illustration and description and is not intended to be exhaustive or to limit the precise forms disclosed. Many modifications, adaptations, and uses thereof will be apparent to those skilled in the art.

Claims

1. A minimally invasive surgical device, comprising: A handle having an electrical port for receiving voltage or current and transmitting the voltage or current to a surgical tip; A first grasping portion mechanically coupled to the handle and having a first internal metal frame and a first insulating overmold on the first internal metal frame, the first internal metal frame including a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion by the first insulating overmold; And A second grasping portion mechanically coupled to the handle and having a second internal metal frame and a second insulating overmold on the second internal metal frame, Wherein the handle is capable of being coupled to the surgical tip to transmit movement from at least one of the first grasping portion and the second grasping portion to actuate the surgical tip, and wherein one or more of the first internal metal portion or the second internal metal frame are electrically coupled to the electrical port.

2. The minimally invasive surgical device according to claim 1, wherein, The first grasping portion is fixedly coupled to the handle, and the second grasping portion is movably coupled to the handle.

3. The minimally invasive surgical device according to claim 2, wherein, The first grasping portion and the handle include an integral structure.

4. The minimally invasive surgical device according to claim 1, wherein, The handle includes an insulating handle overmold configured to provide an outer surface electrically insulated from the electrical port.

5. The minimally invasive surgical device according to claim 1, wherein, The minimally invasive surgical device further includes a ratchet coupling the first grasping portion and the second grasping portion to limit relative movement between the first grasping portion and the second grasping portion in one direction.

6. The minimally invasive surgical device according to claim 5, wherein, The ratchet is electrically isolated from the first internal metal portion or the second internal metal frame.

7. The minimally invasive surgical device according to claim 5, wherein, The ratchet includes a first ratchet portion coupled to the first grasping portion and a second ratchet portion coupled to the second grasping portion, wherein the first ratchet portion and the second ratchet portion slidably engage with each other to limit relative movement between the first grasping portion and the second grasping portion in the direction.

8. The minimally invasive surgical device according to claim 7, wherein, The second ratchet portion is coupled to the second grasping portion by a fastener, wherein the fastener is coupled to the second insulating overmold and is electrically isolated from the second internal metal frame.

9. The minimally invasive surgical device according to claim 7, wherein, The second internal metal frame includes a notch, wherein the second ratchet portion is coupled to the second insulating overmold by a fastener such that the fastener passes through the notch without contacting the second internal metal frame.

10. The minimally invasive surgical device according to claim 7, wherein, The ratchet further includes a release member for disengaging the first ratchet portion and the second ratchet portion.

11. The minimally invasive surgical device according to claim 5, wherein, The ratchet includes metal, a thermoplastic polymer, or a combination thereof.

12. The minimally invasive surgical device according to claim 1, wherein, One or more of the first internal metal frame, the first internal metal portion, the second internal metal portion, or the second internal metal frame independently includes steel, titanium, or aluminum.

13. The minimally invasive surgical device according to claim 12, wherein, One or more of the first internal metal frame, the first internal metal portion, the second internal metal portion, or the second internal metal frame independently includes stainless steel.

14. The minimally invasive surgical device according to claim 13, wherein, One or more of the first internal metal frame, the first internal metal portion, the second internal metal portion, or the second internal metal frame independently comprises surgical stainless steel.

15. The minimally invasive surgical device according to claim 1, wherein, One or more of the first insulation overmolding or the second insulation overmolding independently comprises a thermoplastic polymer.

16. The minimally invasive surgical device according to claim 15, wherein, One or more of the first insulation overmolding or the second insulation overmolding independently comprises polyetheretherketone or polysulfone.

17. The minimally invasive surgical device according to claim 1, wherein, One or more of the first insulation overmolding or the second insulation overmolding independently exhibits a dielectric strength of 130 kV / cm to 250 kV / cm.

18. The minimally invasive surgical device according to claim 1, wherein, One or more of the first insulation overmolding or the second insulation overmolding is made of a material that can be autoclaved or disinfected.

19. The minimally invasive surgical device according to claim 1, wherein, The minimally invasive surgical device further comprises a control shaft coupled to the handle.

20. The minimally invasive surgical device according to claim 19, wherein, The control shaft is removably coupled to the handle.

21. The minimally invasive surgical device according to claim 19, wherein, The surgical tip is removably coupled to the control shaft.

22. A method for operating a minimally invasive surgical device, comprising: providing a surgical tip and a handpiece comprising the minimally invasive surgical device according to any one of claims 1-21; coupling the surgical tip to the handpiece, the handpiece comprising: a handle having an electrical port for receiving voltage or current and transmitting the voltage or current to the surgical tip; a first gripping portion mechanically coupled to the handle and having a first internal metal frame and a first insulation overmolding located on the first internal metal frame, the first internal metal frame comprising a first internal metal portion and a second internal metal portion, the second internal metal portion being electrically isolated from the first internal metal portion and mechanically coupled to the first internal metal portion by the first insulation overmolding; and a second gripping portion mechanically coupled to the handle and having a second internal metal frame and a second insulation overmolding located on the second internal metal frame; wherein the handle is capable of coupling to the surgical tip to transmit movement from at least one of the first gripping portion and the second gripping portion to actuate the surgical tip, and wherein one or more of the first internal metal portion or the second internal metal frame is electrically coupled to the electrical port; disconnecting the surgical tip from the handpiece; and autoclaving the handpiece.

23. The method according to claim 22, wherein, The surgical tip comprises an electrocautery tool, scissors, a grasper, a punch, or a dissector.

Citation Information

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