High-frequency devices including the jaw area

Abstract

The present invention relates to an HF instrument (1) comprising at least one metal electrode (23), particularly a bipolar instrument for vascular sealing. The metal electrode (23) has a contact surface (25) for contact with tissue. The metal electrode (23) has a support portion (39) facing away from the contact surface (25), the support portion (39) having or being a porous support structure (37). The present invention also relates to a metal electrode (23) manufactured using a generative manufacturing method.

Description

Technical Field

[0001] The present disclosure relates to a high-frequency medical surgical instrument (HF instrument), and more particularly to a bipolar vessel sealing instrument having at least one metal electrode on the jaw portion.

Background Art

[0002] In high-frequency surgery (hereinafter referred to as HF surgery), an alternating current of high frequency is passed through the human body or a part thereof, and the tissue is selectively cauterized (coagulated) or incised (electroincision) by the heat generated at that time. The damaged tissue is later absorbed by the surrounding healthy tissue. A major advantage compared to conventional incision techniques using a scalpel is that bleeding can be stopped simultaneously with the incision by closing the damaged blood vessels in the form of coagulation.

[0003] Currently, the monopolar HF method is most commonly used in HF surgery. In this case, one pole of the HF voltage source is connected to the patient via a counter electrode having as large a surface area as possible. The counter electrode is, for example, a contact portion on the operating table on which the patient lies, a contact arm band, a contact foot band, or an adhesive electrode. This counter electrode is often referred to as a dispersive electrode or a neutral electrode. The other pole is connected to the surgical instrument, which constitutes a so-called active (active) electrode or working electrode. The current flows through the path of minimum resistance from the active electrode to the neutral electrode. The current density is highest in the immediate vicinity of the active electrode, and the thermal effect is maximum at this portion. The current density decreases inversely proportional to the square of the distance. The neutral electrode should have as large an area as possible and be well connected to the body. Thereby, the current density is kept low in the body and burns do not occur. The skin on the neutral electrode is not significantly heated due to the large surface area. Strict safety measures are applied when attaching the neutral electrode. In order to prevent burns, correct positioning and good contact of the neutral electrode (depending on the surgical site) are extremely important.

[0004] In contrast to the unipolar HF method, the bipolar HF method allows the current to flow through a small area of ​​the body, i.e., the area where the surgical effect (incision or coagulation) is desired. Two metal electrodes, insulated from each other, are held within the jaw of the HF instrument, and an HF voltage is applied between them, directing these two metal electrodes directly to the surgical site. The circuit is closed through the tissue between them. The thermal effect occurs within the tissue between the metal electrodes.

[0005] In such HF instruments, particularly bipolar sealing instruments, the jaw portion is preferably manufactured / constructed in a sandwich structure. The jaw portion consists of, or comprises, a thin metal electrode that functions as a contact surface with the tissue, a plastic spacer that provides electrical and thermal insulation, and a carrier member. The carrier member is provided and configured to ensure force transmission and to include a closing mechanism. The carrier member provides the necessary stability and rigidity to the jaw portion.

[0006] However, jaw sections constructed with such a sandwich structure are complex and costly to manufacture. The presence of various components that need to be joined together leads to the accumulation of manufacturing tolerances, which reduces the fit accuracy and, consequently, the quality of the jaw section or HF appliance.

[0007] One approach to overcome these disadvantages has been proposed to construct / form the metal electrode or one branch of the jaw as a solid component. In other words, according to this prior art, the metal electrode is manufactured entirely from a solid (non-porous) material.

[0008] Such solid metal electrodes have particularly high rigidity against thermal and / or mechanical deformation, but they have a large thermal mass. Therefore, especially in large jaws, most of the energy supplied from the HF generator to the metal electrode is consumed by heating the solid metal electrode rather than sealing the tissue. [Overview of the project]

[0009] The purpose of this disclosure is to eliminate, or at least mitigate, the disadvantages of the prior art. In particular, the purpose of this disclosure is to provide an HF instrument that is easy to manufacture, has small tolerances, and has a small thermal mass in its jaw portion.

[0010] The HF equipment according to independent claim 1 and the HF equipment according to the dependent claim solve the above objective. Further advantageous embodiments are described in the dependent claims and in the description below.

[0011] More specifically, the object of this disclosure is to be addressed by the following HF devices, in particular bipolar vascular occlusion devices. The HF device comprises at least one metal electrode. The metal electrode is configured as a solid for contact with tissue, i.e., has a non-porous or closed contact surface. Furthermore, the metal electrode comprises a support facing away from the contact surface. The support has a porous or open support structure, or is a porous support structure. Thus, one aspect of this disclosure is to form / provide the electrode side that (physically) contacts / is in contact with patient tissue as a completely or partially closed non-porous contact surface by arranging a (thin) closed metal plate, closed metal layer, closed metal coating, etc., and to form / provide the other metal electrode as an open (porous or lattice-like, etc.) support structure, at least partially or completely. The open support structure is provided and configured to support the contact surface (at least in some areas) and provide stability against (mechanical and / or thermal) deformation caused by load.

[0012] Here, "solid" means that the contact surface is smooth and uninterrupted.

[0013] In other words, the object of this disclosure is solved by an HF instrument, preferably configured as a bipolar HF instrument, having, for example, a scissor-like or forceps-like configuration, or a laparoscope configuration. The HF instrument comprises at least one, preferably two, metal electrodes configured within each branch of the jaw.

[0014] Preferably, the two branches are movable relative to each other via joints or hinges. The metal electrode includes at least one flat portion, which forms a contact surface and faces the gap / internal space of the jaws. That is, the flat portion forms the front surface of the metal electrode. The contact surface is provided and configured to contact tissue. The metal electrode further includes a support portion configured / oriented to face away from the gap of the jaws. That is, the support portion forms the back surface of the metal electrode. The support portion has or is a porous support structure.

[0015] More specifically, the HF instrument has a distal instrument on which a metal electrode is positioned. In particular, the distal instrument has a jaw portion having two branches, at least one of which is rotatable toward the other branch, and the metal electrode is positioned on at least one branch, on the side facing the other branch. More preferably, the HF instrument has a proximal handle portion and a shaft connecting the handle portion to the distal instrument.

[0016] The porous support structure is preferably made of metal. Porous means that the support structure has a proportion of hollow space, which is preferably uniformly distributed throughout its volume. In other words, the support structure is configured to have multiple hollow spaces arranged three-dimensionally.

[0017] This porous support structure allows for the reinforcement (rigidification) of metal electrodes without significantly increasing their thermally effective mass. Furthermore, by configuring the support structure as an open porous structure, good air and gas circulation is possible, thereby improving thermal insulation.

[0018] The porous support structure may be a structure manufactured additively (additive manufacturing). Additive manufacturing consists of a process of depositing material, preferably in layers. This differs from cutting, which removes material.

[0019] In other words, the porous support structure may be a 3D printed structure, and may be constructed, for example, by selective laser melting, selective electron beam melting, laser cladding, energy deposition by wire arc / plasma arc, or wire-fed electron deposition.

[0020] In one embodiment, the metal electrode may be configured monolithically (integrally) with the support. "Monolithic" means consisting of a homogeneous and inseparable unit.

[0021] In other words, the metal electrode may be constructed as a single piece of material. That is, at least the contact surface and the support portion having a porous support structure may be constructed monolithically as a single piece of material.

[0022] By constructing the metal electrodes monolithically, high component rigidity can be achieved. Furthermore, since the joining process between the support and the contact surface is eliminated, the manufacturing of the metal electrodes can be simplified. In addition, the reduction in the number of parts prevents the accumulation of manufacturing tolerances, resulting in improved manufacturing accuracy and thus an improvement in the quality of the jaw portion of the HF instrument.

[0023] In another embodiment, the metal electrode may include a blade guide channel for guiding the blade. The blade guide channel opens on the contact surface side and extends along the longitudinal direction of the metal electrode.

[0024] In other words, the metal electrode may be integrated with the blade guide channel. The blade guide channel may have a substantially U-shaped cross-section. The blade guide channel may open toward the gap side of the member and close toward the opposite side of the gap. When the jaws are closed, i.e., when the contact surfaces of the two branches are aligned parallel to each other, the blade guide channels of the two metal electrodes may be positioned so that their respective openings face each other, and may jointly define a space having a rectangular or elliptical cross-section.

[0025] The metal electrode may have an elongated shape, and the blade guide channel extends along the longitudinal direction of the metal electrode. In the width direction orthogonal to the longitudinal direction of the metal electrode, the blade guide channel may be arranged at the center, or at least approximately at the center.

[0026] Alternatively stated, the blade guide channel may be configured as a groove shape within the contact surface.

[0027] By constructing a metal electrode provided with a blade guide channel, the number of components of the branch portion can be further reduced, and as a result, the number of components of the jaw portion can also be reduced.

[0028] In another aspect, the blade guide channel and the contact surface may be configured in a substantially T-shape with respect to each other, and the porous support structure may be configured (arranged) in the space or portion defined by the contact surface and the blade guide channel.

[0029] Alternatively stated, the blade guide channel may extend in a step-like manner on the back side of the contact surface (the surface facing in the normal direction with respect to the contact surface). The blade guide channel, together with the contact surface, may define at least one, particularly two volumes / spaces on both sides of the blade guide channel. The porous support structure may be configured within this space or these spaces. The porous support structure may be connected / configured with the contact surface and the blade guide channel, and preferably may be configured as a single piece of material.

[0030] With such a configuration, the metal electrode can be made compact, lightweight, and stable.

[0031] The blade guide channel may have a geometric shape closed towards the back side.

[0032] In another aspect, the support portion may have a solid reinforcing rib (in the sense of being closed / non-porous).

[0033] In other words, in addition to the porous support structure, the support may also be provided with solid reinforcing ribs. The reinforcing ribs preferably segment the support, and the porous support structure may be arranged / configured within the segments thus formed.

[0034] This makes it easier to construct porous support structures, and in particular, reduces the likelihood of manufacturing defects such as localized interlayer bonding failures and defects in additively manufactured porous support structures.

[0035] In another embodiment, the contact surface of the metal electrode is configured in a tongue shape, and the reinforcing ribs are aligned normal to the blade guide channel and preferably arranged / configured to be substantially uniform or uniformly distributed section by section over the entire longitudinal direction of the metal electrode.

[0036] In other words, the contact surface is a long, narrow surface, and may have a rounded tip on one of its short sides (narrow edges). To put it another way, the tip may be located on the distal portion of the contact surface.

[0037] The blade guide channel may extend through the center of the metal electrode, along the extension of the tip. Reinforcement ribs may be arranged in a principal number lateral to the longitudinal direction of the metal electrode. The distance between the reinforcement ribs may be substantially constant.

[0038] In the rounded tip region, one of the rigid ribs may be configured to be substantially aligned in the direction of extension of the blade guide channel.

[0039] In another embodiment, the reinforcing ribs between the blade guide channel and the contact surface may be configured as substantially triangular angle pieces.

[0040] In other words, one side of the reinforcing rib may be positioned at an angle of approximately 45° to the contact surface.

[0041] The orientation or arrangement of these reinforcing ribs makes it possible to absorb bending forces from different spatial directions on or within the metal electrode.

[0042] In another embodiment, the support portion may be enclosed by a plastic sheath.

[0043] In other words, a gap may be formed on the side opposite to the gap between the members, i.e., the side facing outwards, using a plastic sheath to cover the metal electrode.

[0044] The plastic sheath acts as an electrical and / or thermal insulator and protects the porous support structure from localized forces. This is because the plastic sheath distributes the applied force and transmits it to the support structure. Optionally, the plastic sheath may be configured to have a certain elasticity, thereby providing further protection to the support structure, and consequently to the branches and jaws.

[0045] In another embodiment, the plastic sheath may be composed of an overmolded material in which at least a portion engages with the porous support structure.

[0046] In other words, the plastic sheath may engage with / penetrate the pores of the porous support structure, forming an interlocking (fitting) state between the plastic sheath and the porous support structure. The plastic sheath may penetrate the porous support structure completely or only to the surface.

[0047] In other words, the plastic material may fill at least a portion of the porous volume of the support structure.

[0048] By constructing the plastic sheath in this manner, material uneven distribution (accumulation) and resulting distortion of the part during the overmolding process can be avoided / prevented. Furthermore, as the plastic sheath bites into the porous support structure, a good and virtually inseparable bond can be formed between the plastic sheath and the metal electrode. In addition, an additional bonding step between the metal electrode and the plastic sheath can be omitted during the overmolding process. Moreover, any defects present in the porous support structure (near the surface) can be compensated for by the plastic of the plastic sheath.

[0049] In another embodiment, the porous support structure may be configured as a lattice / grid.

[0050] In other words, the porous support structure may consist of a three-dimensionally periodically arranged grid and cell structure. Common grid cells include body-centered cubic cells, face-centered cubic cells, simple cubic cells, or spatial truss structures. Other possible grid types / structures include partgraph grids, volumegraph grids, 3D conformal structure grids, unitgraph grids, quadograph grids, or Gndgraph grids.

[0051] Such lattice structures can be manufactured with varying degrees of porosity using additive manufacturing methods. Because the lattice can absorb forces applied from different spatial directions, it contributes to reinforcing the jaw or metal electrode without significantly increasing its mass. The type of lattice can be adapted / selected according to the type and size of the jaw. It is also conceivable to adapt / select the type of lattice according to its position or load on the metal electrode.

[0052] In another embodiment, the porous support structure may be configured as a sponge structure or a bionic structure. A bionic structure refers to a structure based on shapes found in nature or living organisms.

[0053] In other words, the porous support structure may be configured as, for example, a honeycomb structure or a load-oriented geometry. Furthermore, the porosity (void ratio) of the porous support structure may be configured to differ at different points on the metal electrode, or to be load-oriented. Additionally, the dimensions of the rod structure may be changed or configured differently depending on the load condition or position on the metal electrode. For example, a load-oriented truss structure may be constructed from the rod structure.

[0054] To put it another way, the contact surface of the metal electrode or the metal electrode itself may have a high-load region and a low-load region, and the high-load region may be reinforced relative to the low-load region.

[0055] This configuration allows for a further reduction in the thermally involved (thermally effective) mass of the metal electrodes.

[0056] In another embodiment, the hinge element of the jaw may be integrally constructed (as a single piece of material) from the same material as the metal electrode.

[0057] In another embodiment, the force transmission element of the HF device may be integrally constructed (as a single piece of material) from the same material as the metal electrode.

[0058] In another embodiment, the force transmission element of the HF device may be integrally constructed (as a single piece of material) from the same material as the metal electrode.

[0059] The present disclosure proposes providing a relatively thin, closed (non-porous / non-lattice-like) contact surface, such as a metal layer or metal plate. This contact surface is unstable (easily deformable) against thermal and / or mechanical stress. This is supported (reinforced) by an open (porous / lattice-like) support structure located on the opposite / posterior side from the patient tissue. This support structure is stable (less deformable) against thermal and / or mechanical stress, in other words, it is more rigid than the contact surface (or the layer / plate forming the contact surface).

[0060] Furthermore, the objectives of this disclosure are also addressed by HF devices, particularly bipolar vascular occlusion devices, having at least one metal electrode having a contact surface for contact with tissue. The metal electrode is manufactured by a generative manufacturing method, an additive manufacturing method, or 3D printing. [Brief explanation of the drawing]

[0061] [Figure 1] This disclosure shows the HF equipment. [Figure 2] This disclosure shows the jaw portion of the HF instrument having two branches. [Figure 3] This shows a metal electrode in the branch portion of the jaw that does not have a porous support structure. [Figure 4] This shows the metal electrodes in the branch portion of the jaw, which has a porous support structure. [Figure 5] This shows a cross-section of only one branch of the jaw. [Modes for carrying out the invention]

[0062] Embodiments of this disclosure will be described below with reference to the attached drawings.

[0063] Figure 1 shows the HF instrument according to this disclosure in the form of a bipolar vascular occlusion instrument 1. The vascular occlusion instrument 1 includes an operating section or handle section 3 at its proximal end. The operating section or handle section 3 is provided for the operator / surgeon to grasp and forms a substantially pistol-shaped handle section. A cable 5 is also provided on the operating section or handle section 3. The cable 5 connects the vascular occlusion instrument 1 to a high-frequency generator (not shown). Furthermore, the operating section or handle section 3 has a button 7. By operating the button 7, energy supply from the high-frequency generator can be requested.

[0064] The shaft 9 is distally connected to the operating section or handle section 3. The shaft 9 has a substantially rod-like or tubular shape. The jaw section 11 is located at the distal end of the shaft 9, i.e., the distal end of the vascular sealing device 1. The jaw section 11 is provided to function as a cutting section and a sealing section. The operator can use the jaw section 11 to incise tissue or blood vessels, and then close or seal the incision or blood vessel.

[0065] Figure 2 shows a magnified view of the jaw portion 11 in its open state. The jaw portion 11 comprises a first branch portion 13 and a second branch portion 15. These branches are connected to each other by a hinge 17. Both the first branch portion 13 and the second branch portion 15 are provided with outward-facing plastic sheaths 19.

[0066] When the jaw portion 11 is open, a gap 21 is formed between the two branches 13 and 15 of the jaw portion 11. Both the first branch 13 and the second branch 15 further include a metal electrode 23. The metal electrode 23 includes a contact surface 25. The contact surface 25 of the first branch 13 and the contact surface 25 of the second branch 15 substantially define the gap 21 as flat surfaces. The contact surfaces 25 are provided and configured to contact tissue. The first branch 13 and the second branch 15 are movable relative to each other around the hinge 17 via a handle portion (see 27 in Figure 1). The contact surface 25 of the first branch 13 and the contact surface 25 of the second branch 15 are each configured with a blade guide channel 27 that opens toward the gap 21. The blade guide channel 27 is provided and configured to guide a blade (not shown) that starts from the shaft 9 or from a blade element provided on the shaft 9 in the axial direction. The axial direction is understood to be the longitudinal direction of the shaft 9.

[0067] Figure 3 shows the metal electrode 23 as viewed from the back side, i.e., the side opposite to the contact surface 25. In the embodiment shown in Figure 3, the porous support structure is not shown for the sake of clarity.

[0068] The metal electrode 23 has a substantially tongue-like shape, with its tip portion 29 located at the distal end. A force transmission element 31 is located at the proximal end of the metal electrode 23. A blade guide channel 27 extends between the tip portion 29 and the force transmission element 31. The blade guide channel 27 opens towards the contact surface 25 and has a groove-like shape that extends from the contact surface 25 to the back side, located in the center in the width direction of the metal electrode 23. Furthermore, the metal electrode 23 is equipped with reinforcing ribs 33, which project perpendicularly from the blade guide channel 27. The reinforcing ribs 33 are configured as substantially triangular angle members positioned between the blade guide channel 27 and the contact surface 25. The reinforcing ribs 33 are uniformly distributed along the entire longitudinal direction of the metal electrode 23. In addition, the tip portion 29 is equipped with a reinforcing rib 33 that extends substantially along the longitudinal direction of the blade guide channel 27.

[0069] The metal electrode 23 is further provided with a hinge bolt 35, which extends in the width direction of the metal electrode 23. The hinge bolt 35 has a substantially circular cross-section and constitutes part of the hinge 17.

[0070] The metal electrode 23 is constructed as a single piece of material. In other words, the contact surface 25, blade guide channel 27, force transmission element 31, reinforcing rib 33, and hinge bolt 35 are constructed as a single piece of material (integrally from the same material).

[0071] Figure 4 shows the metal electrode 23 of Figure 3 with a grid 37 as a porous support structure. The grid 37 is located between the contact surface 25, the blade guide channel 27, and the reinforcing rib 33. The grid 37 is integrally constructed from the same material as the metal electrode 23. The grid 37 is a three-dimensional grid structure. Together with the reinforcing rib 33, the grid 37 forms a support portion 39. The support portion 39 substantially forms the back surface of the metal electrode 23 and increases the rigidity of the metal electrode 23 or the corresponding branches 13, 15. The grid 37 is substantially located within the space or spatial portion defined by the reinforcing rib 33, the blade guide channel 27, and the contact surface 25. The grid 37 may start from the contact surface 25 and extend substantially to the blade guide channel 27 on the back side of the metal electrode 23.

[0072] In another embodiment, the support portion 39 may consist only of the lattice body 37. In other words, the metal electrode 23 may be configured without reinforcing ribs 33.

[0073] The lattice 37 is a support structure manufactured additively (additive manufacturing). In other words, the lattice 37 is made of metal using generative manufacturing, additive manufacturing, or 3D printing. Preferably, the entire metal electrode 23 is manufactured by additive manufacturing. However, embodiments in which the lattice 37 is formed or can be formed additively on the base body of the metal electrode 23 are also conceivable.

[0074] The lattice structure 37 is shown here as a rectangular parallelepiped lattice. Of course, other lattice shapes, sponge shapes, or load-adapted bionic structures such as honeycomb shapes are also conceivable.

[0075] Figure 5 shows a cross-section of one of the branches 13 and 15 of the jaw portion 11. The contact surface 25 is substantially T-shaped with the U-shaped blade guide channel 27. The grid body 37 is located between the blade guide channel 27 and the contact surface 25. The plastic sheath 19 is constructed as an overmolded material. This means that the plastic sheath 19 engages with the pores of the grid body 37 and is consequently connected to the metal electrode 23 in a shape-fitting manner. In other words, the metal electrode 23 forms the branches 13 and 15 integrally with the plastic sheath 19. The plastic sheath 19 may penetrate only the surface portion of the grid body 37, or it may penetrate the grid body 37 almost completely. [Explanation of symbols]

[0076] 1 Blood vessel sealing device 3. Operating section or handle section 5 Cables 7 buttons 9 shafts 11. Jaw 13 First branch 15. Second branch 17 Hinge 19 Plastic Sheath 21 Gap 23 Metal electrode 25 Contact surface 27 Blade Guide Channels 29 Tip 31 Force transmission elements 33 Reinforcement Ribs 35 Hinge bolts 37 Lattice 39 Support part

Claims

1. High-frequency (HF) devices (1), particularly bipolar vascular occlusion devices, It comprises at least one metal electrode (23), The metal electrode (23) includes a contact surface (25) configured as a solid for contacting tissue. The HF device (1) further includes a support portion (39) facing away from the contact surface (25) of the metal electrode (23), wherein the support portion (39) has or is a porous support structure (37).

2. The HF device (1) according to claim 1, wherein the metal electrode (23) is monolithically configured with the support portion (39).

3. The metal electrode (23) includes a blade guide channel (27) for guiding the blade. The HF device (1) according to claim 1 or 2, wherein the blade guide channel (27) opens toward the contact surface (25) and extends along the longitudinal direction of the metal electrode (23).

4. The blade guide channel (27) and the contact surface (25) are configured to be substantially T-shaped relative to each other. The HF device (1) according to claim 3, wherein the porous support structure (37) is located in a space or portion defined by the contact surface (25) and the blade guide channel (27).

5. The HF device (1) according to any one of claims 1 to 4, wherein the support portion (39) includes a solid reinforcing rib (33).

6. The contact surface (25) of the metal electrode (23) is configured in a tongue shape. The HF apparatus (1) according to claim 5, wherein the reinforcing ribs (33) are aligned in the direction normal to the blade guide channel (27) and preferably are substantially uniformly distributed over the longitudinal direction of the metal electrode (23).

7. The HF device (1) according to claim 5 or 6, wherein the reinforcing rib (33) between the blade guide channel (27) and the contact surface (25) is substantially configured as a triangular angle material.

8. The HF device (1) according to any one of claims 1 to 7, wherein the support portion (39) is surrounded by a plastic sheath (19).

9. The HF device (1) according to claim 8, wherein the plastic sheath (19) is made of an overmolded material that engages with a porous support structure (37).

10. The HF device (1) according to any one of claims 1 to 9, wherein the porous support structure (37) forms a grid.

11. The HF device (1) according to any one of claims 1 to 9, wherein the porous support structure (37) forms a sponge structure or a bionic structure.

12. High-frequency (HF) devices (1), particularly bipolar vascular occlusion devices, It comprises at least one metal electrode (23), The metal electrode (23) includes a contact surface (25) for contacting tissue. The metal electrode (23) is manufactured by a generative manufacturing method, and the HF instrument (1) is also provided.

13. The HF device (1) according to any one of claims 1 to 12, wherein the metal electrode (23) is configured as a single material piece.

14. The HF device (1) according to any one of claims 1 to 13, wherein the porous support structure (37) is a rigid porous support structure (37).

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