This document pertains generally, but not by way of limitation, to systems and methods including end effectors of medical devices. In particular, this document relates to devices and methods for treating blood vessels or other tissue.
Various different types of energy, e.g., radio frequency (RF) or other electromagnetic energy, plasma energy, or ultrasound energy can be used for vessel sealing, tissue cutting or cautery, tissue ablation, or tissue coagulation, among other things, alone or in combination with mechanical energy delivery (e.g., using a sharp cutting instrument) or manipulation (e.g., using a forceps). Many types of monopolar and bipolar energy devices exist for different surgical purposes. For example, an energy delivery device (“energy device”) can include a forceps that can be used for laparoscopic surgery. The forceps can perform delicate movements inside a patient and can include a gripping assembly and/or a cutting assembly. Further, the forceps can use electrical energy in the gripping assembly. Electrosurgical sealing forceps can further include or use an energy device such as RF, ultrasonic, and microwave vessel sealing devices. The forceps can clamp tissue, and elastin or collagen of the clamped tissue can be melted by the energy device such as can seal the tissue.
For example, jaws located at a distal end of a forceps can be actuated via elements at a handpiece of the forceps to cause the jaws to open and close and thereby engage the vessel or other tissue. Forceps can also include an extendable and retractable blade, such as blades that can be extended distally between a pair of jaws.
Energy devices, such as RF, ultrasonic and microwave vessel sealing devices, require a certain amount of jaw pressure to compress the tissue to create good seals with low thermal margins. Bipolar electrosurgical sealing forceps can employ a pair of jaws with RF energy to coagulate a vessel and further employ a moveable cutting blade to cut the sealed vessel after coagulation.
Some forceps devices can require a high jaw force to compress the vessel tissue for desired sealing results. The high jaw force can cause unwanted tissue damage, since, for example, the jaw force requirements for large vessels and small vessels are different.
The present inventors have recognized, among other things, that tissue treatment procedures using energy delivery can benefit from improvements including reduced procedure time, reduced complications from treatment, and reducing the requisite skill level of the surgeon or other practitioner performing the procedure, such as to help reduce or avoid the need for surgical “tricks” or techniques to accommodate changing conditions at a target site during the procedure. For example, an approach to electrosurgery can include or use an electrosurgical device with a radio frequency (RF) or other electromagnetic energy delivery system for changing a force applied at a target site based on a tissue characteristic such as, e.g., vessel size. For example, a challenge of such approaches for energy delivery can include ‘tissue popping’. Such tissue popping is a phenomenon in which steam generated within the tissue exits, e.g., from between forceps jaws, applying mechanical pressure and electrical energy together, at such speed that it can cause damage to the vessel wall including at one or more locations that can be away from the target vessel sealing site. It can be difficult to avoid tissue popping using, for example, a large-jawed energy device since such a device can tend to apply a significantly different force to a smaller vessel than a force applied to a larger vessel with similar operation of the large-jawed energy device.
This document describes an end effector assembly of a medical device. The end effector assembly can include a jaw assembly including a first jaw member. A second jaw member can be pivotably coupled to the first jaw member at a fulcrum. The jaw assembly can be movable towards a first position where the first and second jaw members can be opposing and spaced apart from each other. Also, the jaw assembly can be movable towards a second position where the first and second jaw members can be positioned closer to each other than in the first position. An electrode can be arranged on an inner surface of the first jaw member or the second jaw member. The electrode can include a plurality of segments, such as extending outward, and arranged in a row, away from the fulcrum. For example, the plurality of segments can include a first segment, such as with a portion of the first segment configured to deform or move in a direction away from an opposing jaw when a tensile force exceeding a specified first threshold force is present at the first segment.
In an example, the first segment can include a first compression feature configured such that a strain from the tensile force localizes disproportionately within the first segment at or near the first compression feature such that the portion of the first segment deforms in a direction away from the opposing jaw. For example, the compression feature can include a necking feature, a serration, an opening, a spring, a tapered region, or a combination thereof.
This document is generally related to medical devices, such as surgical instruments for treating tissue. In an approach to tissue treatment an energy device, such as radio frequency (RF), ultrasonic, and microwave vessel sealing devices, can be used as a part of an electrosurgical sealing forceps. An end effector assembly, such as including a forceps, can provide a desired jaw pressure such as to compress the tissue for electrosurgical sealing. The energy devices can be used such as to apply energy to treat one or more tissue components, e.g., collagen or elastin of the tissue, and the heated or melted components can be used such as to seal to the tissue. Certain electrosurgical sealing forceps can also include a cutting element as part of the end effector, such as a stationary or moveable cutting blade to cut the sealed vessel. Such devices can use a relatively high jaw closure force to compress the vessel tissue for sealing. A problem with this approach, however, that an undesired jaw closure force can cause unwanted tissue damage during the procedure if the tissue is not held at an appropriate target tissue pressure. For example, an appropriate target pressure can vary based on the surface area the jaws is filled with tissue, and a range of variance can be relatively large for jaw devices capable of compression forces of greater than about 65 newtons (N). Herein, the term “about” is used to connote a margin of error of between plus or minus 10% of the reference value. It can be desirable to deliver a compression force at a particular pressure between about 40N and about 70N of force, such as about 68N of force. In perhaps more preferred examples for different sized devices, it can be desirable to deliver a compression force at a particular pressure between about 35 to 60 N of force for smaller devices, and 50 to 75 Newtons of force for larger devices. Providing such an appropriate target tissue pressure can be challenging for users, for example, if the region between the jaws is not filled with tissue. In such a case, the closure force needed from the end effector to supply the target tissue pressure can vary based on the amount of tissue is in contact with a contact surface area of the jaws. For instance, at a fixed closure force in a case in which the jaws compress a relatively small amount of tissue, a greater tissue pressure is supplied than in a case in which the jaws compress a relatively large amount of tissue at the same fixed closure force. Also, providing the desired tissue pressure can be challenging for users due to varying tissue thickness, morphology, size, volume, density, composition, moisture content, and the like. Generally, the “target tissue pressure” can refer to relatively small range of acceptable pressures for the procedure and supplying the target tissue pressure can be significant such as for a user to perform a successful procedure. If too little closure force is applied, the tissue is compressed at too small of a tissue and the resultant seals created can be very low in their ‘burst pressure’ (e.g., the blood pressure required to prevent the created seal from breaking). This is because the ‘glue’ created from the melted elements of the vessels such as the collagen, is not squeezed together sufficiently. This insufficient pressurization of the glue can result in a weakness at the pressure-treated joint interface and results in poor seals. If too great of closure force is applied, the tissue pressure is too great and, irrevocable tissue damage can occur such as tearing and ripping of the tissue. Also, if too great of closure force is applied, the tissue pressure is too great and, tissue popping can occur when the steam generated within the tissue while applying energy is trapped between the jaws at the high pressure until the jaws are released following the procedure. At this point, the steam within the walls of the vessel can escape at a high velocity and can damage surrounding tissue. This can result in behind-the-seal weaknesses that can later burst during times of patient recovery from anesthesia or post-operatively (due to the increase of a patient's blood pressure meeting the particular blood pressure level within the vessel that causes failure at the weakened location of the “sealed” blood vessel).
The present inventors have recognized, among other things, that creating a tissue treatment system that can provide a variable closure force based on the amount of tissue along the contact area of the jaws, can help a user achieve the target tissue pressure between the jaws during energy delivery treatment, such as for vessel sealing.
Furthermore, the tailored energy outputs described herein can be used in systems that deliver any type of energy output that is compatible with a particular end effector or device. For example, tailoring an energy output can include tailoring the ultrasonic energy or radiofrequency energy delivered by to or by an ultrasonic forceps, or tailoring the thermal energy delivered to or by forceps or other device for one or more treatments such as cutting, sealing, coagulation, ablation, desiccation, fulguration, or the like.
The end effector assembly 104 can include or use a jaw assembly 106. The jaw assembly 106 can include a first jaw member 108 and a second jaw member 110. The second jaw member 110 can be pivotably coupled to the first jaw member 108 about a pivot axis or other pivot point 112. One or more drives 119 can be included or used in the device 102, such as housed within the hand piece 118 and mechanically coupled to the end effector assembly 104. Also, one or more drives 119 can be included at or near the distal end of the assembly 104 such directly driving the jaw assembly 106. For example, the drive 119 can include a mechanism for electrically, mechanically, pneumatically, or hydraulically transferring energy applied to an actuator 120 to operate the jaw assembly 106.
Here, the plurality of deformable segments 220 can selectively apply a maximum force locally to a single area of the jaw. This can help allow the jaw to provide a force per area and help achieve an appropriate target tissue pressure. In an example, at least one of the plurality of deformable segments can also be included as part of the electrode 211 for delivering electrosurgical energy to the target site. In an example, the end effector assembly 204 includes a plurality of deformable segments 220, such as sequentially extending outward in a row away from the fulcrum.
An individual jaw member 208 can include or use an electrode 211, such as arranged on an inner surface of the first jaw member 208A or the second jaw member 208B. While depicted in
As depicted in in the detail view in
Not all of the plurality of deformable segments 220 need have the same deflection force against a force of deformation. For example, certain areas of an individual jaw member 208A or 208B can deform when subject to a lower force or a higher force than another area of the jaw member. This can help allow a physician to utilize specific areas of the individual jaw 208A or 208B such as for specific tasks. For example, a specified first threshold force at the first segment 220A can be different than a specified second threshold force at the second segment 220B. For example, a specified first threshold force at the first segment 220A can be greater than a specified second threshold force at the second segment 220B. In an example, the first segment 220A can be arranged such as to deform more than the first segment 220B upon being subject to the same tensile force.
Different materials, material thicknesses, and segment lengths can affect the force required to cause the mechanical bias 438 to depress and can be tuned to the specific requirements of the device, can be characterized by F=kx, where F is the applied force, k is the spring constant and x is the amount of displacement. Alternatively, “necking” or another form of reduced cross-sectional area or voids such as by drilling, stamping, punching or etching can be introduced to reduce the second moment of inertia. This is characterized by a buckling force constitutive equation:
where P is the buckling load, E is the Young's modulus, I is the 2nd moment of area and L is the length of the column.
In an example, the compression feature limits twisting, deformation in any one direction or contact with an adjacent segment upon compression thereof. Preventing such twisting can help prevent the electrode from impeding the track of a vessel sealing device that includes a cut blade, prevent the electrode from moving closer to the tissues that are outside of the general footprint of the device, increasing ‘thermal margin or tissue effect area into unwanted or unexpected areas; twisting or deforming into an adjacent segment and becoming locked or supporting itself and altering the deformation force; trapping or scissoring tissues that transverse one or more segments and damaging the tissue by cutting or not allowing a subsequent release of the tissue once the jaw has been opened.
The mechanical bias 438 can be made from a number of different materials, including polymers, elastomers or metals. In the example where the spring material is metallic, it can be formed by folding or etched, laser cut, or stamped, or any other suitable process for forming a spring, such as coiling. In some examples, the mechanical bias 438 can include a metal-based spring system that uses two springs to equalize the pressure from side to side to provide a parallel drop to the contact area of the jaw member. In other examples, the mechanical bias 438 can be located generally centrally in a lateral direction. The mechanical bias 438 can be also be located generally centrally in the lateral direction (i.e., along the length of the jaw), or can be biased towards a distal portion of the respective segment or the proximal portion of the respective segment.
One or more protection coverings 421 (e.g., layer) can be included to cover an individual segment or a plurality of segments such as to minimize or impede tissue from becoming trapped between a plurality of segments or to help provide a non-stick contact surface for contacting tissue. For example, the protection covering 421 can be formed of polymers, metals, foils and metals, for example, polycarbonate, polyurethane, polysulfone, polyethylene, polypropylene, polyimide, polyfluorocarbon, polyvinyl chloride, polyvinylidene chloride, polystyrene, poly(vinyl chloride-co-vinyl alcohol), polyamide, poly(methyl methacrylate), polyethylene terephthalate, poly(ethylene-co-vinyl acetate). For example, an additional flexible or semi flexible element can be introduced from below to fill the gaps between the segments but still allow the deflection of a single segment element.
In an example, an individual segment can be formed such as by etching or laser cutting an electrode shim and form to shape and then integrated the shim into a compliant material such as an elastomer or foam. For example, the electrode can be an array of “pads”, connected through linkages from the sheet metal to form electrical continuity. In on example, the vertical linkages can be “kink” or bent to form a spring if needed. An advantage of using a compliant material is that it will give a viscoelastic property that potentially can be gentle to the tissue clamped between the jaws. This can be characterized by a combination of F=kx and also a damping effect of the compliant material, damping ratio, expressed by the formula:
Where c=damping coefficient; m is the mass and con is the natural frequency.
In an example, an individual electrode shim can include a thickness between about 0.05 millimeters (mm) and about 1 mm. Particularly, an individual electrode shim can include a thickness between about 0.20 mm and about 0.30 mm.
The standoff 542 can be conductive or insulative, while remaining arranged such as to prevent shorting from one jaw to the other. For example, a conductive stope can be at least partially surrounded by an insulative media such as to prevent it from electrically connecting on the side of the jaws on which it is insulated. In an example, an individual segment can include or use an electrically nonconductive standoff element configured to impede a first jaw member from physically contacting a second jaw member when the first and second jaw members can be moved towards each other.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples in which the invention can be practiced. These examples are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other examples can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical document. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together to streamline the document. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or examples, with each claim standing on its own as a separate embodiment, and it is contemplated that such examples can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application relates claims priority to U.S. Provisional Application Ser. No. 63/270,709, filed on Oct. 22, 2021, which is incorporated by reference herein in its entirety, and the benefit of priority of which is claimed herein.
Number | Date | Country | |
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63270709 | Oct 2021 | US |