Electrode instrument for use in a surgical hand device, surgical hand device, component of a surgical hand device and method for using an electrode instrument

Abstract

Electrode instrument (16) for use in a surgical hand device, in particular in a resectoscope (10), with at least one electrical conductor (21), which may preferably be designed as a sheathing tube (27), wherein an RF electrode (18) can be arranged at a distal end of the at least one conductor (21) and wherein at least one electrical contact means (23) for electrical contacting the RF electrode (18) is arranged at a proximal end of the at least one conductor (21), characterized in that the electrode instrument (16) has at least one electrically conductive connecting component (22) comprising a low-melting-point, electrically conductive alloy.

Description

[0001] The invention relates to an electrode instrument for use in a surgical hand device according to the preamble of claim 1. The invention further relates to a surgical hand device according to claim 15. In addition, the invention relates to an electrically conductive component in conjunction with a surgical hand device according to claim 16. Claim 17 claims a method for using an electrode instrument.

[0002] Surgical hand instruments of this type, such as resectoscopes, are primarily used in urology for electrosurgical applications. In these applications, the instruments are typically used for the resection or vaporization of tissue. For this purpose, the surgical hand instrument may have an electrosurgical passage instrument that can be moved along a shaft. After the instrument is inserted into the human body, its distal working end can be advanced from a distal end of the shaft tube. This passage instrument is usually an electrode instrument with an electrosurgical electrode or an RF electrode at its distal end. This electrode may, for example, be in the form of a loop, a head, or similar.

[0003] For the applications mentioned above, the electrode or electrode instrument is supplied with a high-frequency electric current. The electrode is typically supplied with electrical energy via a feeder on the handheld device, which in turn is connected to an external high-voltage source, as described, for example, in DE 10 2010 035 319 A1. Before use, the electrode instrument is inserted into a corresponding receptacle on the feeder to establish a mechanical and electrical connection. This supplies the electrode or tool with electrical energy via an electrical conductor or sheath and a contact on the electrode instrument. Depending on the design of the electrode instrument, it may have either two contact pins—an active pin and a return pin—or only a single pin, the active pin.In instruments of this type, the active current path can be guided into the electrode through a Teflon body, while the return path is routed via the transporter or all external conductive surfaces (“ground”).

[0004] Electrode instruments of this type are generally used as single-use products, meaning they must be disposed of after a single use, as described, for example, in DE 10 2016 107 611 A1. However, it cannot be ruled out that these single-use electrode instruments are reprocessed and deliberately reused after use. This multiple use of single-use products constitutes intentional misuse. Since this multiple use compromises both patient safety and the functionality of the electrode instrument, such as the conductivity of a bearing and material wear, reprocessing of the instruments must be prohibited.

[0005] The invention is therefore based on the objective of creating an electrode instrument and a surgical hand device that can ensure patient safety and the reliable functionality of the instrument.

[0006] A solution to this problem is described by the features of claim 1. Accordingly, an electrode instrument comprising at least one electrical conductor and an RF electrode arranged at a distal end of the at least one conductor, as well as an electrical contact means at the proximal end of the at least one conductor, has at least one electrically conductive connecting component comprising a low-melting-point electrically conductive alloy. The electrical conductivity of this connecting component is dimensioned such that it is suitable for the normal RF operation of the electrode instrument. However, at excessively high temperatures, the conductive alloy melts, and the electrical conductivity between the contact means and the RF electrode is interrupted. This exposure of the connecting component to excessive thermal energy thus leads to the inactivation of the electrode instrument.Since electrode instruments are heated during reprocessing, the cleaning process causes the alloy to melt, thus interrupting electrical conductivity. This prevents reuse and ensures patient safety and the functionality of the electrode instrument. The electrical conductor may also be the sheathing of the electrode instrument.

[0007] In particular, the invention may further provide that the at least one electrical contact means consists of at least two separate parts arranged distal and proximal to the connecting component, wherein the at least two separate parts of the electrical contact means can be electrically connected to each other by the connecting component. When the connecting component melts, these two separate parts of the contact means are at least electrically separated from each other, resulting in an interruption of the electrical conductivity.

[0008] Furthermore, according to the invention, after the alloy has melted, particularly after deformation and / or removal of the connecting component, the electrical connection between the (preferably distal) conductor or a (particularly active) contact tube or wire, or the sheathing tube, and the electrical contact element is interrupted. This irreversible interruption precludes reuse of the electrode instrument. The user is then left with only the option of disposing of the instrument and using a new electrode instrument that meets both the strictest hygiene requirements and the functional requirements.

[0009] Furthermore, according to the invention, it is conceivable that after the alloy melts, particularly after deformation and / or removal of the connecting component, a gap forms between the at least two separate parts of the at least one electrical contact element, thereby interrupting the electrical connection between the at least two separate parts of the at least one electrical contact element. It is also conceivable that the melting process mechanically separates the electrical contact element from the electrical conductor or the electrode sheath. This separation of the electrical contact element from the conductor prevents the instrument from being reused in a particularly safe manner. Moreover, this separation provides the user with a clear indicator that the electrode is no longer usable.

[0010] Preferably, the electrically conductive connecting component can further establish an electrically conductive connection between the electrical conductor or electrode sheath and the electrical contact element. This electrically conductive connecting component is suitable for normal RF operation of the electrode instrument. However, due to the low-melting-point alloy, the connecting component is not suitable for reprocessing. If the connecting component is exposed to excessive thermal energy, the alloy melts and the connection between the contact element and the conductor or sheath is interrupted.

[0011] Preferably, the low-melting-point, electrically conductive alloy melts at a temperature of 50°C or higher. A temperature of 50°C to 150°C is preferred. A temperature of 60°C to 135°C, particularly 121°C, is further preferred.

[0012] The metallic alloy of the connecting component is selected from the group comprising a Field metal (51In32, 5Bi16, 5Sn), indium bismuth eutectic (66, 3In33, 7Bi), bismuth indium eutectic (67Bi33In), and indium tin eutectic (52In48Sn). These metals or materials are particularly well-suited as an electrical connection between the contact medium and the conductor or sheathing tube and simultaneously offer a low melting point, so that at least some deformation of the connecting component can be achieved during instrument reprocessing.

[0013] Another advantageous embodiment of the present invention may provide that a connecting pin is arranged inside the at least one electrical contact element and / or inside the at least one electrode sheathing tube and inside the connecting component. This connecting pin prevents the two separate parts of the electrical contact element from being mechanically separated from each other if the connecting component melts. Mechanical separation of the two parts of the contact element can lead to contamination of a cleaning bath or the like. The connecting pin avoids the need for cleaning the bath.

[0014] It is preferably provided that the connecting pin comprises a non-electrically conductive material, preferably a plastic or a ceramic. By choosing these materials, sufficiently high mechanical stability can be achieved without any electric current flowing between the separate parts of the contact element.

[0015] In a preferred embodiment, the connecting pin is rod-shaped and serves as a mechanical connection between the electrical contact element and the electrode sheath or between two separate parts of the electrical contact element. It is also conceivable that the connecting pin has a different shape, such as a tube or the like.

[0016] Furthermore, it is conceivable that the two separate parts of the electrical contact element, which are electrically connected to each other by the connecting component, can be kept apart by a pre-tensioned spring, preferably a compression spring made of an electrically insulating material. As soon as the connecting component melts and thus both the electrical and mechanical connection between the two separate parts of the electrical contact element is severed, the two separate parts are forced apart by the pre-tensioned spring. This prevents the melting alloy from establishing an electrical connection between the two ends of the separate parts. For this purpose, at least one of the two separate parts of the electrical contact element can be movably mounted after melting.

[0017] Furthermore, according to the invention, it is conceivable that at least one of the two mutually aligned ends of the separate parts of the electrical contact means, or both ends, have an insulating element, preferably an insulating washer. The at least one insulating element prevents the two ends of the separate parts from shifting after the joining component has melted, thereby creating an electrical contact between them. Likewise, it prevents the two ends from being electrically coupled to each other by the molten alloy. It is also conceivable that an insulating element is assigned to each end, against which one end of the spring abuts.

[0018] It is also preferable that the space between the two separate parts of the electrical contact element be larger than the volume of the molten connecting component. By ensuring that the space between the two separate parts of the electrical contact element is larger than the volume of the molten connecting component, it can be prevented that the space is completely filled with the electrically conductive alloy and that an electrical contact is established between the two ends of the separate parts. Rather, the invention provides that the molten alloy has sufficient space to flow away from the area between the two separate parts.

[0019] A surgical hand device for solving the aforementioned problem has the features of claim 15. Accordingly, it is provided that the surgical hand device, which may be, for example, a resectoscope, is equipped with an electrode instrument according to at least one of claims 1 to 14.

[0020] An electrically conductive component for solving the aforementioned problem has the features of claim 16. Accordingly, the component, when used in conjunction with a surgical handpiece, which may be, for example, a resectoscope, is electrically conductive in at least one region and simultaneously melts at a low temperature. Melting an electrically conductive alloy interrupts the conductivity of the component. This melting prevents the component from being reused after reprocessing, which is generally carried out by applying heat. These components may be, for example, electrical conductors, cables, particularly RF cables, a shaft, or other components used with a surgical handpiece.

[0021] A method for using an electrode instrument to solve the aforementioned problem comprises the measures of claim 17. Accordingly, it is provided that, in a first step, an electrode instrument according to at least one of claims 1 to 11 is provided, and in a second step, the electrode instrument is heated to a temperature of at least 50°C, preferably to a temperature of 50°C to 150°C, and more preferably to a temperature of 60°C to 135°C. This inactivation of the electrode instrument by melting a connecting component renders it unusable. This melting of the connecting component prevents the electrical conductivity of the component or the instrument, thus destroying the functionality of the electrode instrument.

[0022] A preferred further development of the method provides that the melting of the connecting component results in an interruption of the electrical connection and / or a deformation of the connecting component or removal of the connecting component from the electrode instrument.

[0023] A preferred embodiment of the invention is described in more detail below with reference to the drawing. The drawing shows: Fig. 1 a schematic representation of a surgical hand instrument, in particular a resectoscope, Fig. 2 a close-up of a proximal end of an electrode sheath tube, Fig. 3 a representation of a further embodiment of a proximal end of an electrode sheath tube, and Fig. 4 a representation of a further embodiment of a proximal end of an electrode sheath tube

[0024] One possible embodiment of the present invention is described in the Fig. Figure 1 shows a highly schematic lateral sectional view of a resectoscope 10 with an electrode instrument 16. In addition to the embodiment of the electrode instrument 16 discussed below, it is also conceivable that an electrically conductive connecting component according to the invention, comprising a low-melting-point electrically conductive alloy, is used in another component in connection with the use of a surgical hand instrument. For example, it is conceivable that the aforementioned connecting component is integrated into a cable, in particular an RF cable, a shaft, a cap, or the like.

[0025] The one in Fig. The resectoscope 10 shown in Figure 1 essentially consists of a transporter 11 to which a handle 12 is attached and a shaft 13. The shaft 13, shown here in a highly schematic form, extends from the transporter to the distal end of the resectoscope 10. For a detailed description of a resectoscope, reference is made to the relevant prior art.

[0026] Within the shaft 13, the electrode instrument 16 is mounted with at least one electrical conductor 21. This at least one electrical conductor 21 can also be at least one sheathing tube 27. It is conceivable that the electrode instrument 16 has two sheathing tubes. Furthermore, within the shaft is an optic 15, also shown here in a highly schematic form. The optic extends from a proximal end of the resectoscope 10 to the distal end of the resectoscope 10. At its proximal end, the optic 15 has an eyepiece 17. At the distal end of the resectoscope 10, the optic 15 projects out of the shaft 13.

[0027] In the embodiment of a resectoscope 10 shown here, the electrode instrument 16 is mechanically and electrically coupled to a proximal end of the conductor 21 or the sheathing tube 27 in the transporter 11. While the mechanical coupling serves to stabilize the entire electrode instrument 16, the electrical contact allows an electrode 18, located at the distal end of the electrode instrument 16 and which may be, for example, a cutting loop, to be supplied with electrical energy. For this purpose, the corresponding mating contact in the transporter 11 is connected via further conductors to an RF generator (not shown).

[0028] The electrode instrument 16 shown here can be a so-called single-use product. This means that, in preparation for its use, the electrode instrument 16 is inserted into the transporter 11 of the resectoscope 10. After completion of the operation, the electrode instrument 16 is then withdrawn from the transporter 11 and disposed of properly.

[0029] Reusing a single-use product can endanger the patient's health and impair the device's functionality. Devices intended for multiple uses must be reprocessed before reuse. This involves exposing the devices to elevated temperatures. Once the electrode instrument 16 described here is exposed to elevated temperatures for reprocessing purposes, it is deactivated, rendering it unusable.

[0030] The electrode instrument 16, or the at least one conductor 21, or the at least one sheathing tube 27, has an electrical contact means 23 on a proximal section 20, which can be designed, for example, as a plug or contact pin, as shown in Fig. Figure 2 is illustrated using the example of a return electrode or return pin. The electrode instrument 16 is inserted into a corresponding electrical connection 24 in the transporter 11 using this contact element 23. In the Fig. Figure 2 shows a highly schematic representation. According to the invention, an electrically conductive connection component 22 is arranged between the conductor 21 or the sheathing tube 27 of the electrode instrument 16 and the electrical contact means 23. This electrically conductive connection component 22 establishes an electrical connection between the contact pin 23 and the conductor 21 or the sheathing tube 27, so that the electrode 18 can be supplied with electrical energy or an RF voltage. The electrical contact 23 can be configured as either an active pin or a return pin (see Figure 2). Fig. 2, Fig. 3, Fig. 4) Depending on the type of contact 23 or pin, the shape or length of the conductor 21 can also vary. The conductor 21 can extend over the entire length of the at least one sheathing tube 27 or only over a section of the sheathing tube 27.

[0031] According to the invention, the electrically conductive connecting component 22 comprises a low-melting-point electrically conductive alloy. This alloy provides the electrode instrument 16 with, firstly, sufficiently high mechanical stability so that the conductor 21 or the sheathing tube 27 or the electrode instrument 16 can be fixed in the transporter 11, and secondly, the electrical conductivity of the alloy is sufficient to supply the electrode 18 with the corresponding electrical energy.

[0032] As soon as the electrode instrument 16 is exposed to an elevated temperature for reprocessing, such as during autoclaving, the alloy of the connecting component 22 melts and the electrical contact medium 23 detaches from the conductor 21 or the sheathing tube 27. This renders the entire electrode instrument 16 inactivated and unusable. By using a low-melting-point electrical connection, it can be effectively ensured that the entire electrode instrument 16 is non-reusable.

[0033] To ensure that the connecting component 22 between the electrical contact means 23 and the sheathing tube 27 generates sufficient mechanical stability, one embodiment of the invention provides that the connecting component 22 extends both into the interior of the contact means 23 and into the interior of the sheathing tube 27. This increases both the electrical and the mechanical contact area between the individual components.

[0034] In the Fig. Figure 3 shows another embodiment of a connecting component 22. In this embodiment as well, a proximal section 20 of the electrode instrument 16 or the sheathing tube 27 is connected to a terminal 24 of the transporter 11 via an electrical contact element 23. However, here the electrical contact element 23 is divided into two separate parts, which are separated from each other by a connecting component 22. This connecting component 22 is also shown in the Fig. The embodiment shown in section 3 is made of a low-melting-point, electrically conductive alloy. As soon as the electrode instrument or the sheathing tube 27 is installed according to the instructions in the Fig. In the embodiment shown in 3, if the component is exposed to an increased temperature, the connecting component 22 melts and thus the electrical contact between the two separate parts of the electrical contact medium 23 is interrupted.

[0035] So that in the Fig. In the embodiment shown in Figure 3, only the electrical contact between the two separate parts of the electrical contact element 23 is interrupted, but no mechanical separation takes place. Therefore, the two separate parts of the contact element 23 are firmly connected to each other via a connecting pin 25. This connecting pin 25 is electrically non-conductive. A plastic or ceramic material is a possible material for the connecting pin 25. This mechanical coupling of the two separate parts of the electrical contact element prevents the detached connector 23 from contaminating the cleaning bath during autoclaving. Cleaning the bath is very complex. In the embodiment shown in Figure 3, the electrical contact element 23 is not only electrically conductive but also functionally conductive. Fig. In the embodiment of the electrode instrument 16 and the sheathing tube 27 shown in Figure 3, only the melted or deformed alloy and the connecting component 22 remain in the cleaning bath. The contact pin 23 remains attached to the proximal section 20 of the electrode sheathing tube 27.

[0036] In the Fig. Figure 4 shows a proximal section 20 of the electrode instrument 16 with an active pin. The connecting component 22 connects there, as already shown for the embodiment of the Fig. 2 and Fig. As described in Figure 3, the electrical contact medium 23 consists of two separate parts. While the proximal part of the electrical contact medium 23 is connected to the RF generator via appropriate leads, the distal part of the contact medium 23 leads directly to the electrode 18. To electrically insulate the electrode sheath or the sheath tube 27 from the contact medium 23, the latter is enclosed in a tube-like structure by insulation 26. This also applies to the contact medium described in the Fig. In the embodiment shown in Figure 4, when the connecting component 22 melts, an electrical and mechanical separation occurs between the two separate parts of the electrical contact medium 23.

[0037] It can further be provided that a space exists between or within the two separate parts of the electrical contact medium 23 that is larger than the volume of the molten alloy. This prevents the molten alloy from electrically connecting the two separate parts of the contact medium 23 to each other.

[0038] As a further development, it can also be provided that the two ends of the separate parts of the electrical contact element 23 are pushed apart by a pre-tensioned spring (not shown). While the two parts of the contact element 23 are held together by the connecting component 22, when the component 22 melts, the spring forces the two parts apart, thus additionally ensuring that the electrical connection is broken.

[0039] In addition to the embodiment described here, it is also conceivable that other areas or other components of the electrode instrument 16 or the surgical hand device are made of a low-melting-point alloy and that, upon melting, electrical conductivity is interrupted, thus inactivating the electrode instrument 16 or the hand device.

[0040] According to the invention, the connecting component 22 is conductively connected to the conductor 21 or the sheathing tube 27 and the electrical contact means 23, for example, by means of a crimping process. Alternatively, it is conceivable that the connecting component 22 is soldered directly to the sheathing tube 27 and the connector pin 23. Reference symbol list 10 Resectoscope 11 Carrier 12 Handle unit 13 shaft 14 shaft tube 15 Optics 16 Electrode instrument 17 eyepiece 18 electrode 20 proximal section of the electrode instrument 21 leaders 22 Connection component 23 Electrical contact medium 24 connection to the carrier 25 Connecting pin 26 Insulation 27 Electrode sheath tube or sheath tube

Claims

[1] Electrode instrument (16) for use in a surgical hand device, in particular in a resectoscope (10), comprising at least one electrical conductor (21), which may preferably be designed as a sheathing tube (27), wherein an RF electrode (18) can be arranged at a distal end of the at least one conductor (21) and wherein at least one electrical contact means (23) for electrical contacting the RF electrode (18) is arranged at a proximal end of the at least one conductor (21), characterized by , that the electrode instrument (16) has at least one electrically conductive connecting component (22) comprising a low-melting, electrically conductive alloy. [2] Electrode instrument (16) according to claim 1, characterized by, that the at least one electrical contact means (23) consists of at least two separate parts which are arranged distal and proximal to the connecting component (22), wherein the at least two separate parts of the electrical contact means (23) can be electrically connected to each other by the connecting component (22). [3] Electrode instrument (16) according to claim 1 or 2, characterized by , that after melting of the alloy, in particular after deformation and / or removal of the connecting component (22), the electrical connection between the, preferably distal, conductor (21) or a, in particular active, contact tube or wire or the sheathing tube (27) and the electrical contact means (23) is interrupted. [4] Electrode instrument (16) according to any one of the preceding claims, characterized by, that after melting of the alloy, in particular after deformation and / or removal of the connecting component (22), a gap is created between the at least two separate parts of the at least one electrical contact means (23), thereby interrupting the electrical connection between the at least two separate parts of the at least one electrical contact means (23). [5] Electrode instrument (16) according to any one of the preceding claims, characterized by , that after melting of the alloy, in particular after deformation and / or removal of the connecting component (22), the at least one electrical contact means (23) is mechanically separated from the conductor (21) or the electrode sheath tube (27). [6] Electrode instrument (16) according to any one of the preceding claims, characterized by, that an electrically conductive connection can be established between the conductor (21) or the electrode sheath tube (27) and the electrical contact medium (23) by means of the electrically conductive connecting component (22). [7] Electrode instrument (16) according to any one of the preceding claims, characterized by , that the low-melting, electrically conductive alloy melts from a temperature of 50°C, preferably at a temperature of 50°C - 150°C, more preferably at a temperature of 60°C - 135°C, wherein the alloy comprises at least one metallic component. [8] Electrode instrument (16) according to any one of the preceding claims, characterized by , that the metallic alloy is selected from the group comprising Field's metal (51In32.5Bi16.5Sn), indium bismuth eutectic (66.3In33.7Bi), bismuth indium eutectic (67Bi33In) and indium tin eutectic (52In48Sn). [9] Electrode instrument (16) according to any one of the preceding claims, characterized by , that a connecting pin (25) is arranged inside the at least one electrical contact means (23) and / or inside the at least one electrode sheath tube (27) and inside the connecting component (22). [10] Electrode instrument (16) according to claim 9, characterized by , that the connecting pin (25) comprises a non-electrically conductive material, preferably a plastic or a ceramic. [11] Electrode instrument (16) according to claim 9 or 10, characterized by , that the connecting pin (25) is rod-shaped and serves as a mechanical connection between the electrical contact means (23) and the electrode sheath tube (27) or between two separate parts of the electrical contact means (23). [12] Electrode instrument (16) according to any one of the preceding claims, characterized bythat the two separate parts of the electrical contact means (23), which are electrically connected to each other by the connecting component (22), can be kept apart by a pre-tensioned spring means, preferably a compression spring made of an electrically insulating material. [13] Electrode instrument (16) according to any one of the preceding claims, characterized by , that at least one of the two mutually aligned ends of the separate parts of the electrical contact means (23) or both ends have an insulating means, preferably an insulating washer. [14] Electrode instrument (16) according to any one of the preceding claims, characterized by , that a space between the two separate parts of the electrical contact medium (23) is larger than the volume of the molten connecting component (22). [15] Surgical hand instrument, in particular resectoscope (10), characterized by, that the surgical hand instrument, in particular the resectoscope, is equipped with an electrode instrument (16) according to at least one of claims 1 to 14. [16] Electrically conductive component, in particular cable, RF cable, shaft or the like, in connection with a surgical hand device, in particular with a resectoscope (10), characterized by , that the component is equipped in at least one area with an electrically conductive connecting component (22) comprising a low-melting, electrically conductive alloy, wherein the electrical conductivity of the component is interrupted when the alloy melts. [17] Method for using an electrode instrument (16), characterized by the steps: a) Providing an electrode instrument (16) according to at least one of claims 1 to 14; b) Heating the electrode instrument (16) to a temperature of at least 50°C, preferably to a temperature of 50°C - 150°C, more preferably to a temperature of 60°C - 135°C; and c) Inactivating the electrode instrument (16) by melting a connecting component (22) of the electrode instrument (16). [18] Method according to claim 17, characterized by , that in step c) an electrical connection is interrupted and / or the connection component (22) is deformed or the connection component (22) is removed from the electrode instrument (16).

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