Medical device and method for manufacturing the same

A hollow handle design with metallic materials and vent openings addresses the durability and weight issues of impact instruments, providing a stable and durable medical instrument with effective impact transmission and easy cleaning.

JP7785011B2Active Publication Date: 2025-12-12エースクラップ·アクチェンゲゼルシャフト
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Patent Information

Application Number
JP2022559737
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-03-31
Filing Date
2021-03-26
Publication Date
2025-12-12
Estimated Expiration
2041-03-26

AI Technical Summary

Technical Problem

Medical instruments, particularly impact instruments like osteotomes and chisels, face challenges with handles that are either too heavy (when made of sturdy steel) or lack durability (when made of plastic or plastic-coated materials), necessitating improved mechanical stability and long-term durability.

Method used

The handle is designed as a hollow handle made of metallic materials with a cavity, allowing for reduced weight and enhanced mechanical stability, and is hermetically sealed with vent openings to prevent contamination and deformation during curing.

Benefits of technology

The hollow handle design provides a stable, lightweight instrument that can transmit impact pulses effectively, ensuring extended use without fatigue and facilitating easy cleaning and reprocessing.

✦ Generated by Eureka AI based on patent content.

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Abstract

To improve medical instruments, particularly impacting instruments having a proximal end and a distal end, an instrument has been proposed in which a handle and a proximally facing impacting surface are disposed or formed at the proximal end, a tool element is disposed or formed at the distal end, and an instrument shaft of the instrument extends from the proximal end to the tool element. It has been proposed, among other things, that the handle be in the form of a hollow handle to allow for better handling. Furthermore, a method for manufacturing the medical instrument has been proposed.
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Description

[Technical Field]

[0001] The present invention relates to a medical instrument, particularly an impacting instrument, having a proximal end and a distal end, the proximal end having a handle and a proximally-facing impacting surface disposed or formed thereon, and the distal end having a tool element disposed or formed thereon, with the instrument shaft extending from the proximal end to the tool element.

[0002] The present invention further relates to a method for manufacturing a medical instrument, and in particular, to a method for manufacturing an impacting instrument having a proximal end and a distal end, the proximal end having a handle and a proximally-facing impacting surface disposed or formed thereon, and the distal end having a tool element disposed or formed thereon, the instrument having an instrument shaft extending from the proximal end to the tool element. Summary of the Invention [Problem to be solved by the invention]

[0003] Medical instruments of the type mentioned at the outset are known, for example, in the form of orthopedic instruments, which are used as impact instruments, for example in the form of osteotomes, chisels, etc. The use as impact instruments requires high mechanical stability of the instruments, i.e., in particular against impact, torsional or bending stresses.

[0004] A particular challenge with such instruments is their handles: for example, a sturdy steel handle is very heavy, while a plastic or plastic-coated handle typically does not have the long-term durability required for the rigorous reprocessing of medical devices.

[0005] The object of the present invention is therefore to improve the type of medical device mentioned at the outset and the method for producing such a medical device, in particular so that the medical device can be handled better. [Means for solving the problem]

[0006] According to the invention, this object is achieved in a medical instrument of the type mentioned at the outset in that the handle is configured in the form of a hollow handle.

[0007] Furthermore, developing the aforementioned type of medical instrument using the proposed method offers several advantages. In particular, the weight of the handle, i.e., the hollow handle, can be significantly reduced if it is made entirely of one or more metallic materials. Furthermore, such an instrument can be configured with a continuous instrument shaft, also referred to as the instrument's core. If the core is made of a metallic material, the instrument shaft can be formed to be resistant to twisting, bending, and impacts, allowing the instrument to be used, for example, as an impact instrument. Thus, impact pulses applied to the impact surface can be immediately transmitted through the instrument shaft to the distal end, i.e., the tool element. Because the hollow handle is not a solid structure, one or more cavities formed in the handle can reduce its weight. This, among other things, allows the surgeon to use the instrument for extended periods of time without fatigue, allowing for the transmission of forces required for surgical procedures.

[0008] Preferably, the hollow handle comprises at least one handle shell, particularly preferably two handle shells, surrounding the instrument shaft, and preferably a cavity is formed between the at least one handle shell and the instrument shaft. The cavity can, among other things, be configured in the form of an annular space. The handle shells can be formed, for example, from hollow parts by so-called hydroforming. Providing two, three or more handle shells can, among other things, simplify the manufacture of the instrument. At least one handle shell can be permanently connected to the instrument by a suitable connection method.

[0009] Advantageously, the cavity is hermetically closed. In particular, the cavity can be closed by welding and / or by a closing element. A hermetically closed cavity can prevent contaminants from collecting in the cavity. In other words, the hermetic closure can improve the cleanliness of the device.

[0010] Preferably, the instrument comprises a vent opening, which fluidly connects the cavity of the hollow handle to the instrument's environment. Preferably, the vent opening is closed, particularly hermetically closed. Such a vent opening is particularly advantageous in the manufacture of such instruments. When multiple components are first connected and then the entire instrument undergoes a curing process at high temperatures, e.g., about 1000°C, the air contained in the cavity may expand due to the heat. This may, among other things, cause, for example, an ergonomically shaped handle shell of the hollow handle to deform into an undesirable shape due to gas pressure generated in the cavity during curing. The vent opening can provide gas venting. Among other things, the vent opening is closed again after the instrument has cured. This, in turn, hermetically closes the cavity of the hollow handle from the instrument's environment.

[0011] The vent opening can be easily closed by a closure element and / or by soldering or welding. Both the vent opening as initially provided and the vent opening that has been closed, for example after the instrument has hardened, can be identified in a ready-to-use instrument by a simple method, for example by tapping the instrument in the area of ​​the hollow handle. Any material or closure element inserted from the outside through the vent opening into the cavity of the hollow handle during welding can be easily detected in this way.

[0012] Preferably, the vent openings are configured in the form of bores or slits on at least one handle shell, in this way it is possible to easily realize a predetermined vent opening in the hollow handle.

[0013] It is advantageous to form the vent opening by not completely welding at least one handle shell to the instrument shaft and / or not completely welding at least two handle shells to each other. Configuring the vent opening in this way has the advantage, among other things, that no additional drilling needs to be provided, which can simplify the manufacture of the instrument. Closure of the vent opening, e.g., by a post-process weld after hardening the instrument, can also be easily detected on the instrument, since the post-process weld does not undergo a hardening process and is structurally different from a hardened weld seam.

[0014] The manufacture of the instrument can be simplified, inter alia, by the hollow handle with two handle shells configured in the form of half shells, and, inter alia, the number and length of weld seams can be minimized overall.

[0015] In particular, to allow the hollow handle to be ergonomically shaped in a simple manner, it is advantageous for at least one handle shell to have a thickness of approximately 0.5 mm to approximately 2 mm. In particular, it can have a thickness of approximately 0.8 mm to approximately 1.4 mm. For example, at least one handle shell can be laser cut from a metal sheet approximately 1 mm thick and then formed into the desired shape by deep drawing. During forming, a flared rim can be provided on the handle shell, which allows for the realization of a flange butt edge seam. This weld seam shape, in particular, makes it possible to omit the introduction of additional welding material.

[0016] According to a further preferred embodiment of the present invention, a proximal handle flange and a distal handle flange spaced apart therefrom can be disposed or formed on the instrument shaft, and at least one handle shell can be configured to surround the instrument shaft between the proximal and distal handle flanges. In this way, the instrument shaft extends through the hollow handle over its entire length, thereby allowing, as previously described, impact pulses acting on the proximal end of the instrument to be transmitted immediately through the instrument shaft, i.e., the core of the instrument, to the distal end and a tool element disposed thereon. The two handle flanges can also facilitate the disposition of the at least one handle shell on the instrument shaft and their predetermined connection to each other and to the instrument shaft.

[0017] Preferably, the distally facing annular surface is disposed or formed on the proximal handle flange. Preferably, the proximally facing annular surface is disposed or formed on the distal handle flange. Preferably, the proximal end face of at least one handle shell facing proximally abuts the proximal handle flange. Preferably, the distal end face of at least one handle shell facing distally abuts the distal handle flange. The annular surface configured as described above allows for a defined positioning of the at least one handle shell on the instrument shaft. This allows for a defined, optimal connection of the instrument shaft to the handle shell to form a hollow handle. For example, the connection between the handle shell and the handle flange can be achieved by circumferential butt welding using a welding additive.

[0018] By forming the vent opening by not completely welding at least one handle shell to at least one of the two handle flanges, the device can be constructed in a simple manner. In this way, there is no need to provide an additional perforation in one of the at least two handle shells. The vent opening thus constructed can be closed, for example, by welding after the device has hardened.

[0019] In order to be able to form an instrument that is as robust as possible, it is advantageous if the instrument is made entirely of one or more metallic materials. Thus, in particular, all components forming the instrument shaft and at least one handle shell can be made of metallic materials. In particular, the metallic materials of all components can be the same material.

[0020] To be able to create an optimal impacting instrument, it is advantageous if the impact plate is located or formed at the proximal end of the instrument and defines an impact surface, so that the impact pulse from the surgeon can be transmitted simply and reliably to the instrument, and in particular to the instrument shaft of the instrument.

[0021] The proximal handle flange is preferably located on or formed on the impact plate, or the proximal handle flange forms the impact plate. This configuration can simplify the manufacture of the instrument, since the instrument shaft, particularly in the region of the handle, can be configured as a rotating part.

[0022] The tool is preferably of one-piece construction, particularly in such a way that it cannot be disassembled without destruction. This means that the tool can be made from multiple components. For example, the tool can be made from an instrument shaft and two half shells, which are fixedly and irremovably connected to each other. This allows for the formation of a one-piece tool that cannot be disassembled, particularly for cleaning purposes. Such a one-piece tool can only be disassembled into its original components by irreversible destruction.

[0023] To simplify the production of different instruments, it is advantageous if the instrument shaft comprises a handle portion and a tool portion, which are connected to one another by means of a force-locking and / or positive locking and / or material bonding. In particular, the handle portion and the tool portion are permanently connected to one another. This arrangement makes it possible, among other things, to combine the handle portion and the tool portion with one another in any way. For example, instruments can be constructed with handle portions of the same shape but different tool elements. In particular, handle portions of different shapes, for example optimized for left-handed or right-handed users, can be formed and then connected to the corresponding tool portion to form an integrated instrument.

[0024] It is advantageous for the handle configuration if a proximal handle flange and a distal handle flange are arranged or formed on the handle portion. As already mentioned, the handle portion with the hollow handle described above can be formed in a predetermined manner, for example, with different ergonomic shapes or different sizes. Such handle elements can, inter alia, be manufactured in advance and, if necessary, can be connected to the desired tool portion with a corresponding tool element.

[0025] When the handle portion and the tool portion are soldered or welded together, they can be fixedly connected to each other in a simple and reliable manner.

[0026] To further improve the stability of the instrument and the transmission of the shock pulse from the proximal end to the distal end, the impact plate and the handle portion are preferably constructed as one piece, and in particular the impact plate and the handle portion may be monolithically formed.

[0027] Furthermore, the handle portion and the proximal and / or distal handle flanges are preferably of one piece construction. In particular, the handle portion and the proximal and / or distal handle flanges may be of monolithic construction. This construction can be achieved, in particular, by configuring the handle portion with the handle flanges as a rotating part. In particular, the handle portion with the handle flanges may be of a completely rotationally symmetrical construction. An ergonomic shape of the handle can be achieved by appropriately designing at least one handle shell.

[0028] According to a further preferred embodiment of the present invention, the instrument may comprise a connecting device including a first connecting element and a second connecting element, one of which is arranged or formed at the distal end of the handle portion and the other of which is arranged or formed at the proximal end of the tool portion, and the first and second connecting elements in the connecting position are connected to each other in a force-locking and / or positive-locking and / or material-bonding manner. Providing such a connecting device on the instrument has the advantage, among other things, of enabling a standardized connection between the handle portion and the tool portion. Thus, handle portions of different shapes can be coupled to tool portions of different shapes and can be fixedly connected to each other in a predetermined manner. The force-locking and / or positive-locking connection can be achieved, for example, by screwing the connecting elements together. Alternatively or additionally, they may be fixedly connected to each other by material bonding, for example, soldering or welding.

[0029] In order to easily achieve the connection between the handle part and the tool part, it is advantageous if the first connecting element is configured in the form of a connecting receptacle and the second connecting element is configured in the form of a connecting protrusion corresponding to the connecting receptacle. For example, the connecting element can have a sufficient length in the region of the connecting device relative to the longitudinal axis of the instrument, thereby forming an instrument that is sufficiently resistant to twisting and bending. This is particularly advantageous for the stability of the instrument, especially in the case of a two-part instrument shaft.

[0030] Advantageously, a vent opening is formed in the instrument, fluidly connecting the connection receptacle to the instrument environment, and advantageously, the vent opening is closed, in particular, airtightly closed. The vent opening may, in particular, be fluidly connected to a cavity in the hollow handle. Thus, instead of one of the vent openings described above, the vent opening also vents the cavity. In particular, when the instrument is cured, it may serve to vent the cavity and prevent undesired deformation of the at least one handle shell during curing.

[0031] The ventilation openings are advantageously formed in the handle part or in the tool part, for example in the tool part a longitudinal channel can be opened in the connecting element of the tool element, and when the tool part and the handle part are connected to each other the connecting channel can be in fluid connection with the cavity of the hollow handle by a transverse connection.

[0032] To achieve a high corrosion resistance of the instrument, it is advantageous if the instrument shaft and / or handle and / or tool elements are made of stainless steel. In particular, all of the components described may be made from the same steel. In this way, color differences that may occur when using different materials do not occur.

[0033] To improve the impact resistance of the hollow handle, the stainless steel is advantageously made of chromium steel, in particular martensitic chromium steel, which minimizes the risk of damage when the handle is subjected to lateral stress.

[0034] The stainless steel is preferably a hardenable steel, whereby the impact resistance of the at least one handle shell can be easily increased by hardening.

[0035] It is particularly advantageous if the stainless steel is material 1.4021 according to DIN EN 10088. This material can be formed, in particular, into a metal sheet and deep-drawn to the desired shape. Furthermore, this material can be hardened by heat treatment at approximately 1000°C.

[0036] The appliances are preferably hardened, which allows good corrosion resistance to be achieved, which can be further improved, inter alia, by a corresponding surface treatment after hardening.

[0037] To form a chisel or osteotome, the tool element preferably has a cutting edge facing distally.

[0038] The hollow handle can be ergonomically shaped to further improve handling of the instrument for the surgeon, for example it can be shaped differently to be held by left-handed and right-handed users.

[0039] According to further preferred embodiments of the invention, the instrument can be configured in the form of a chisel, a cement removal chisel, an osteotome, a hollow chisel, a dislocation lever, an extraction instrument for prostheses or a tamper. The described instrument configuration allows for versatile use in a variety of cases where high impact stresses and a very long service life of the instrument are required.

[0040] The object stated at the outset is further achieved according to the invention by a method as stated at the outset, in which the handle is configured in the form of a hollow handle.

[0041] As already explained in detail, this allows for the creation of a medical instrument with a stable and lightweight handle. Furthermore, it allows for the immediate transmission of the impact pulse from the proximal end to the tool element located or formed at the distal end. The hollow handle configuration also saves material, thus making it possible to create an ergonomic handle that is easy to use and saves resources.

[0042] Preferably, the hollow handle is made from at least one, in particular two, handle shells surrounding the instrument shaft, with a cavity preferably being formed between at least one handle shell and the instrument shaft. In particular, the cavity can be configured in the form of an annular space. The handle shells can be formed, for example, from hollow parts by so-called hydroforming. Providing two, three, or even more handle shells to form the hollow handle can simplify the manufacture of the instrument. In particular, such handle shells can be carried laterally to the instrument shaft and connected thereto. The formed cavity allows for a weight reduction in the area of ​​the handle, which is advantageous for the user.

[0043] Advantageously, the cavity is hermetically closed. In particular, the cavity can be closed by welding and / or by a closing element. As already explained, bacteria cannot enter or escape from the cavity, which ensures optimal cleaning and reprocessing of the instrument.

[0044] According to a preferred embodiment of the present invention, the instrument may be provided with a vent opening formed therein. The vent opening fluidly connects the hollow handle cavity to the instrument's environment, and the vent opening is closed. In particular, the vent opening can be closed airtightly. In particular, the vent opening has manufacturing advantages by preventing excessive pressure from being generated by air trapped in the hollow handle cavity when the instrument is cured at high temperatures, and preventing undesirable changes in the outer shape of at least one handle shell, particularly deformation. As mentioned above, closing the vent opening ensures that bacteria, in particular, cannot enter the cavity, thereby enabling safe and durable handling and use of the instrument.

[0045] The vent opening can be easily closed by a closure element and / or soldering or welding. Among other things, an airtight closure of the cavity can be achieved. Furthermore, the proposed approach is advantageous because it requires only one small vent opening, which can ensure pressure equalization between the cavity and the environment of the fixture when curing at high temperatures. Therefore, the lack of strength due to multiple welded or soldered joints can be avoided.

[0046] For example, the vent openings may be configured in the form of bores or slits in the at least one handle shell. Such vent openings may be made in a variety of ways.

[0047] It is particularly preferred to form the vent opening by not completely welding at least one handle shell to the instrument shaft and / or not completely welding at least two handle shells to each other. A vent opening formed in this way has the advantage, among other things, that no additional work steps, such as drilling or milling, are required to form it. Therefore, among other things, at least one handle shell can be utilized without any damage or modification to form the hollow handle.

[0048] Advantageously, a proximal handle flange and a distal handle flange spaced apart therefrom are disposed or formed on the instrument shaft. Advantageously, at least one handle shell is disposed between the proximal and distal handle flanges and surrounds the instrument shaft. This configuration of the two handle flanges allows, among other things, a defined positioning of the at least one handle shell on the instrument shaft for connection thereto. This significantly simplifies the manufacture of the instrument.

[0049] To further simplify optimal positioning of the at least one handle shell on the instrument shaft, a distally facing annular surface is preferably disposed or formed on the proximal handle flange. Preferably, a proximally facing annular surface is disposed or formed on the distal handle flange. Preferably, a proximal end face of the at least one handle shell facing proximally is disposed opposite the proximal handle flange. Preferably, a distal end face of the at least one handle shell facing distally is disposed opposite the distal handle flange. Such an annular surface configuration allows for a defined positioning of the at least one handle shell on the instrument shaft, thereby simplifying the connection of the at least one handle shell to the instrument shaft.

[0050] The vent opening can be formed simply by not completely welding the at least one handle shell to at least one of the two handle flanges. For example, a weld seam annularly surrounding the instrument shaft for connecting the at least one handle shell to one of the two handle flange shafts to form the vent opening does not have to be completely closed.

[0051] In order to be able to form an instrument that is sufficiently stable for use as an impact instrument, it is preferable that the instrument is made entirely of one or more metallic materials, and in particular, if the instrument is made of only one metallic material, a uniform color scheme of the instrument can be achieved, i.e., all parts of the instrument can be made of the same metallic material.

[0052] To further improve the stability of the instrument, it is advantageous to arrange or form an impact plate at the proximal end of the instrument defining the impact surface, in particular the impact plate being formed integrally with the instrument shaft, whereby the instrument shaft can be manufactured together with the impact plate, for example as a rotating part.

[0053] In order to be able to create a device that is particularly resistant to twisting, bending and impacts, it is advantageous for the device to be constructed in one piece, and in particular to be non-disassemblable, so that it can be separated into its original components only by breaking it, in this way it is possible, among other things, to prevent the device from undesirably breaking apart into its individual parts during use.

[0054] To simplify the manufacture of the instrument, it is advantageous if the instrument shaft is made from a handle portion and a tool portion, which are connected to one another by means of a force-locking and / or positive locking and / or material bonding method. In particular, the handle portion and the tool portion can be permanently connected to one another. Non-disconnectable in this sense means, among other things, that the parts can be disassembled from one another only by destroying the entire instrument. Since the handle portion and the tool portion can be selectively connected to one another as needed and, in theory, can be connected arbitrarily, forming the instrument shaft from two parts allows for many variations in the manufacture of medical instruments. This can be achieved, among other things, by a standardized connection between the handle portion and the tool portion.

[0055] The proximal and distal handle flanges are advantageously located or formed on the handle portion, which may be formed of a completely hollow handle, which may then be connected, for example, by welding and / or screwing, to various tool portions having different tool ends.

[0056] The handle portion and the tool portion can be soldered or welded together in a simple and reliable manner.

[0057] The impact plate and the handle portion are preferably of one piece, in particular of monolithic construction, which may be achieved, in particular, by forming a rotating part, thereby reducing the number of assembly steps in the manufacture of the tool.

[0058] It is further advantageous if the handle portion and the proximal and / or distal handle flanges are of one piece, particularly a monolithic construction. In this way, the handle portion, particularly with the exception of at least one handle shell, can be made from one piece. The impact pulse can then be transmitted distally through the impact plate and through the hollow handle towards the tool portion.

[0059] With regard to manufacturing, it is preferred, inter alia, that the instrument is configured with a connecting device including a first connecting element and a second connecting element. Also, it is preferred that one of the two connecting elements is arranged or formed at the distal end of the handle part. Preferably, the other of the two connecting elements is arranged or formed at the proximal end of the tool part. Preferably, the first connecting element and the second connecting element in the connecting position are connected to each other in a force-locking and / or positive locking and / or material bonding manner. Such a connecting device is, inter alia, capable of connecting the tool part to the associated handle part in a defined and standardized manner. In particular, any handle part and any tool part may each be formed with the same connecting element, thereby allowing any combination of handle parts and tool parts and a defined connection therebetween.

[0060] If the first connecting element is configured in the form of a connecting receptacle and the second connecting element in the form of a connecting protrusion corresponding to the connecting receptacle, the connecting elements can engage with each other in a simple manner, and during production, regardless of the design of the tool part and the handle part, similar manufacturing steps can always be carried out to connect the two parts.

[0061] Preferably, a vent opening is formed in the instrument, fluidly connecting the connection receptacle to the environment of the impact instrument. Preferably, the vent opening is closed, in particular hermetically closed. Closing the vent opening can occur, among other things, after the instrument has hardened. The vent opening can, for example, provide a fluid connection to a cavity in the hollow handle, as described above, to prevent deformation of the at least one handle shell during hardening.

[0062] The vent openings are preferably formed in the handle portion or the tool portion, which, among other things, allows for the vent openings to be formed in a manner that is most easily achievable in manufacturing and that does not negatively affect the stability of the instrument.

[0063] Preferably, the instrument shaft and / or the handle and / or the tool element are made of stainless steel, which makes it possible, inter alia, to ensure high resistance of the instrument to corrosion.

[0064] To further improve the corrosion resistance of the appliance, chromium steel can preferably be used as the stainless steel, in particular martensitic chromium steel, which can be hardened by heat treatment, in particular, which can help to further improve the stability of the appliance.

[0065] Preferably, hardenable stainless steel is used as the stainless steel, which, as already mentioned, allows the stability and service life of the equipment to be further improved.

[0066] The use of material 1.4021 in accordance with DIN EN 10088 as stainless steel simplifies the production of instruments, especially hollow handles. At a heat treatment temperature of approximately 1000°C, this material is slightly less hard than material 1.4301, but after heat treatment it becomes significantly harder, which makes the hollow handle, especially its at least one handle shell, less susceptible to undesired deformation due to lateral impact loads.

[0067] To increase the stability and corrosion resistance of the tool, it is advantageous to harden the tool. Hardening the metal material in the manner described above allows, among other things, the use of a handle shell with a reduced thickness, which makes it easier to reshape, for example by deep drawing of stamped sheet metal, without significantly or even at all impairing the impact stability in the area of ​​the handle.

[0068] The tool is preferably hardened at a temperature of approximately 1000° C. This makes it possible, among other things, to significantly increase the impact resistance of the material 1.4021.

[0069] It may be advantageous to harden the instrument after the handle and tool parts have been connected, which can improve the stability of the joint, particularly between the handle and tool parts.

[0070] Preferably, the instrument is hardened after the connection of at least one handle shell to the instrument shaft, in this way the connection between the handle shell and the instrument shaft, i.e., in particular the weld seam, is also hardened, which allows the desired improvement in the stability and corrosion resistance of the instrument.

[0071] According to another preferred embodiment of the invention, the vent openings and / or ventilation openings can be closed after curing, as they no longer have a function after curing and can be closed to improve the cleanliness of the device.

[0072] A uniform appearance of the appliance can be achieved, inter alia, by surface treatment, in particular by polishing, which, inter alia, allows a uniform appearance and avoids color variations, especially if all components of the appliance are made of one uniform material.

[0073] Surface treatment can be easily carried out by belt grinding, and above all, such a process can also be carried out fully automatically by machine.

[0074] Preferred embodiments of the present invention will now be described with reference to the drawings. [Brief explanation of the drawings]

[0075] [Figure 1] 1 is a partial cutaway view of a first embodiment of a medical device. [Figure 2] FIG. 10 is a perspective view of another embodiment of a tool portion. [Figure 3] FIG. 10 is a partially cutaway perspective view of another embodiment of a tool portion. [Figure 4] 1 is a schematic exploded view of an embodiment of a handle portion. [Figure 5] 10 is a schematic, partially cut-away view of another embodiment of the handle portion. FIG. [Figure 6] 6 is a view of the handle portion of FIG. 5 as seen from the direction of arrow A. FIG. [Figure 7] 7 is a partially cutaway side view of the handle portion of FIG. 6 as seen from the direction of arrow B. FIG. [Figure 8] 8A and 8B are a schematic perspective view, a partially cutaway view, and a cross-sectional view of the handle portion of FIG. 7. [Figure 9] 9 is an enlarged view of area C in FIG. 8 of the handle portion during curing. [Figure 10] FIG. 10 is a close-up view of region C after curing with the vent opening closed. [Figure 11] 10 is a schematic longitudinal cross-sectional view of the handle region of another embodiment of a medical instrument. FIG. [Figure 12] 12 is a cross-sectional view of the tool portion of FIG. 3 along line 12-12 with the handle portion attached. [Figure 13] 10 is a schematic side view of a portion of another embodiment of a medical device. [Figure 14] 14 is a view of the handle portion of FIG. 13 as seen from the direction of arrow D. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0076] 1 is a schematic diagram of a first embodiment of a medical instrument 10. The medical instrument 10 is configured as a chisel 12 in the form of an impacting instrument 14.

[0077] The instrument 10 defines a proximal end 16 from which extends distally a handle 20. The proximal end 16 is defined by a proximally facing impact surface 18.

[0078] An instrument shaft 22 extends from the proximal end 16 to the distal end 24 of the instrument 10 and has a tool element 26 formed thereon having a cutting edge 28 facing distally.

[0079] The instrument shaft 22 defines a longitudinal axis 30 .

[0080] The handle 20 is configured in the form of a hollow handle 32, the construction of which will be described in detail below.

[0081] The instrument shaft 22 includes a handle portion 34 and a tool portion 36, which are connected to one another by force-locking, positive locking, and material bonding methods. In the embodiment shown in FIG. 1, the handle portion 34 and the tool portion 36 are permanently connected to one another, meaning that the handle portion 34 and the tool portion 36 can be separated from one another only by destroying the instrument 10.

[0082] The tool portion 36 is a one-piece, monolithic construction.

[0083] The device 10 includes a connecting device 38 having a first connecting element 40 and a second connecting element 42 .

[0084] The first connecting element 40 is formed at a distal end 44 of the handle portion 34. The second connecting element 42 is formed at a proximal end 46 of the tool portion 36.

[0085] As shown schematically in FIG. 1, in the connected position, the first connecting element 40 and the second connecting element 42 are engaged or connected to each other in a force-locking, positive locking, and material bonding manner.

[0086] The first connecting element 40 is configured in the form of a connecting receptacle 48 , namely in the form of a blind hole 50 .

[0087] The second connecting element 42 is configured in the form of a connecting protrusion 52 , i.e. a connecting protrusion 52 that corresponds to the connecting receptacle 48 .

[0088] The connection receptacle 48 is formed coaxially with the longitudinal axis 30 and opens in a distal direction. The connection protrusion 52 faces in a proximal direction and can be inserted into the connection receptacle 48. Both the connection protrusion 52 and the connection receptacle 48 are rotationally symmetrical with respect to the longitudinal axis 30.

[0089] Connecting projection 52 projects proximally from flange-like stop 54 and is surrounded by an annular surface 56 defined by stop 54, said annular surface 56 extending transversely, i.e., perpendicular in the embodiment shown in FIG. 1 , to longitudinal axis 30 and facing proximally, thereby forming a stop for distally facing annular surface 58, which defines distal end 44 of handle portion 34. Annular surface 58 is formed on a distal handle flange 60 of handle portion 34.

[0090] The cylindrical shaft portion 62 of the handle portion 34 is formed on its proximal side with an impact plate 64 that defines a proximal handle flange 66. The side of the impact plate 64 facing proximally defines the impact surface 18.

[0091] In this manner, the proximal handle flange 66 and the distal handle flange 60 are positioned or formed a distance from one another on the instrument shaft 22 .

[0092] Distal handle flange 60 is formed with a set-back portion that defines a proximally-facing annular surface 68. Similarly, proximal annular flange 66 is formed with a distally-facing annular surface 70.

[0093] To form the hollow handle 32, the instrument 10 includes a plurality of handle shells 72. In the embodiment shown in Figure 1, two handle shells 72 are provided in the form of half shells 74. The two half shells 74 surround the instrument shaft 22 in the region of the shaft portion 62.

[0094] The wall 76 defined by the handle shell 72 has a thickness 102 of approximately 1 mm. The handle shell is laser cut from a sheet metal blank and formed into the desired ergonomic shape by a deep drawing process.

[0095] The half shell 74 surrounds the shaft portion 62 at a predetermined distance to form a hollow space 78. The hollow space 78 is bounded proximally by the proximal handle flange 66, distally by the distal handle flange 60, and radially away from the longitudinal axis 30 by the half shell 74. Furthermore, an annular space is defined by the outside of the shaft portion 62 in a direction toward the longitudinal axis 30.

[0096] Half shell 74 has a proximal-facing proximal end surface 80 and a distal-facing distal end surface 82. The spacing between handle flange 60 and handle flange 66 is dimensioned so that proximal end surface 80 abuts annular surface 70 of proximal handle flange 66 and distal end surface 82 abuts annular surface 68 of distal handle flange 60, facing proximally.

[0097] The rims of the half shells 74 are flanged, i.e., provided with flange-like flared rims 84. The longitudinally extending flared rims 84 abut one another in face-to-face contact. The distally and proximally facing flared rims define a distal end face 82 on the one hand and a proximal end face 80 on the other hand.

[0098] Starting at the proximal end 16 of the instrument and extending distally, the cross-section of the hollow handle 32 increases, i.e., continuously increases, until it reaches a maximum value, which is located closer to the proximal handle flange 66 than to the distal handle flange 60. Starting at the maximum value, the cross-section of the hollow handle 32 continuously decreases until it reaches a minimum cross-section, which is formed such that the distance between the minimum cross-section and the distal handle flange 60 is closer than the distance between the maximum cross-section and the proximal handle flange 66. From this minimum point, which defines a relative minimum in cross-sectional area of ​​the hollow handle 32, the cross-sectional area again increases until a relative maximum cross-sectional area point 86 is formed near the distal end face 82. The relative maximum cross-sectional area point 86 forms a type of anti-slip means for the operator's thumb.

[0099] The handle shell 72 is provided with a plurality of grooves 88 extending circumferentially relative to the longitudinal axis 30, the grooves 88 having different lengths and extending over a circumferential angle of between 60° and 150° relative to the longitudinal axis 30.

[0100] The handle 34 is constructed as a rotating part made of material 1.4021, a hardenable martensitic stainless steel. In one of the two half shells 74, in the region between the relative maximum point 86 and the distal end face 82, a vent opening 90 in the form of a bore 92 is formed.

[0101] To form the hollow handle 32, the two half shells 74 are positioned around the handle portion 34 between the annular surfaces 68 and 70, and abut each other with longitudinally extending flared rims 84 that define end faces 82 and 80 on the half shells 74 that abut the annular surfaces 68 and 70, respectively. The handle shell 72 is formed by welding along the flared rims 84 with a flange butt edge seam. The unique geometry of the weld seam makes it possible to omit the introduction of additional welding filler material.

[0102] The half shells 74 are connected to one another at the proximal and distal sides by welding with a circumferential butt weld using a welding additive.

[0103] The tool part 36 can also be made of material 1.4021. The connecting elements 40 and 42 engage with each other, and the handle part 34 is welded to the tool part 36 in the region of the connecting device 38, i.e. by means of a circumferential weld seam in the region of the abutting annular surfaces 56 and 58.

[0104] Thus, the device 10 is essentially all configured as shown diagrammatically in FIG.

[0105] To enhance the impact resistance of the hollow handle 32 sleeve defined by the handle shell 72, the instrument 10 formed by welding its components is hardened. Vent openings 90 are provided to allow air contained within the cavity 78 defining the annular space 94 to expand during the hardening process, which occurs at a temperature of approximately 1000°C. The half shells 74 defining the hollow handle 32 form a substantially elliptical cross-section. The vent openings 90 prevent excessive pressure within the annular space 94 from deforming the half shells 74 and causing the elliptical cross-sectional profile to approach a cylindrical profile.

[0106] A vent opening 90 fluidly connects the cavity 78 to the environment 100 of the device.

[0107] After the device 10 is cured, the vent opening 90 is closed with a welding additive, as shown schematically in Figure 10. The welding additive within the vent opening 90 forms a closure element 96 that closes the cavity 78. If all of the weld seams, indicated by arrows 98 in Figures 6 and 7, are of an airtight configuration, the annular space 94 as a whole can be hermetically closed by the closure element 96.

[0108] In another embodiment, the closure element 96 is formed by a metal pin that, after the device 10 has hardened, is inserted into the vent opening 90 and connected to the device 10 by welding.

[0109] The previously described embodiments of the device 10 are made entirely from a single metallic material.

[0110] In alternative embodiments, individual components, such as handle shell 72, may be made of a different material than, for example, handle portion 34 and tool portion 36.

[0111] The previously described embodiments of device 10 are of one-piece construction. As previously described, by using welds to connect the components of device 10, device 10 is non-disassembly-able, meaning that device 10 cannot be separated into its original components without destroying it, as intended.

[0112] The above-described embodiments of the instrument 10 are also highly impact resistant and highly corrosion resistant. An impact pulse applied to the impact surface 18, for example by a hammer, is immediately transmitted through the instrument shaft 22 to the tool element 26.

[0113] After closing the vent opening 90, the exterior surface of the device 10 may be surface treated, for example, by grinding or polishing, particularly by belt grinding. Such reworking of the device 10 can result in no welding bumps or annealing marks remaining.

[0114] In an alternative embodiment, the closure element 96 may be configured, for example, in the form of a wire pin that is welded superficially and circumferentially to, among other things, one of the handle shells 72. Tungsten inert gas welding and laser beam welding can alternatively be used to weld the components together, among other things, to close the vent opening 90.

[0115] Another embodiment of a tool portion 36 for forming the instrument 10 is shown schematically in Figure 2. The tool element 26 at the distal end of the tool portion 36 is configured in the form of a narrow chisel tip and has a cutting edge 28 facing distally. A pin-shaped spacer element 104 is formed laterally on the tool element 26. The spacer element 104 has a cylindrical body and a spherical end 106 facing distally.

[0116] Proximally, the design of the tool portion 36 of Figure 2 corresponds to the embodiment of the tool portion 36 of Figure 1. This allows the tool portion 36 to be connected to the hollow handle 32 in a similar manner as described above for the tool portion 36 according to the embodiment of Figure 1 to form the medical instrument 10 in the form of a cement removal chisel.

[0117] For ease of explanation, identical structures and elements on tool portion 36 are numbered identically in the embodiment of FIG. 2, as well as in the embodiment of FIG. 3 described below.

[0118] 3 shows another embodiment of a tool element 36 for forming a surgical instrument 10. The distal end of the tool portion 3 forms a narrow, slightly arched chisel tip having a cutting edge 28 distally thereto.

[0119] Proximally, the tool portion 36 of Figure 3 has substantially the same configuration as the proximal end of the tool portion 36 according to the embodiment of Figures 1 and 2, except that a vent opening 108 in the form of a bore is provided here. The vent opening 108 extends transversely to the longitudinal axis 30 and fluidly connects the environment 100 of the instrument 10 to a blind hole 112 that opens the connecting projection 52 proximally.

[0120] The vent opening 108 functions similarly to the vent opening 90 previously described in connection with the hollow handle 32 illustrated in FIGS. 1 and 4-11.

[0121] To create a fluid connection between the environment 100 and the cavity 78, an opening 116 transverse to the longitudinal axis 30 is formed near the proximal end of the connecting receptacle 48, and the opening 116 fluidly connects the connecting receptacle 48 to the cavity 78. The connection device 38 is then designed such that the proximal end 46 of the connecting projection 52 is at least partially open, leaving the opening 116. This allows air that expands within the cavity 78 during instrument curing after connecting the hollow handle 32 to the tool portion 36 to escape through the opening 116, the connecting receptacle 48, the blind hole 112, and the vent opening 108 to the environment 100.

[0122] The hollow handle 32, partially shown in FIG. 12, is otherwise similar in construction to the hollow handles shown in FIGS. 1 and 4-11.

[0123] In another embodiment, the vent opening 90 is not configured in the form of a bore 92, but instead in the form of a slit 120, the function of which, when appropriately positioned, corresponds to the function of the bore 92 described above. By way of example, such a slit 120 is shown in dashed lines in the embodiment shown in FIG. 13.

[0124] Furthermore, as an alternative to the previously described configuration of vent openings 90 in the form of bores 92, flared rims 84 may not be completely welded to one another or to annular surfaces 68 and 70, but instead may be left unwelded in short sections at any point of the weld seam that is to be formed, leaving narrow slits or gaps where no weld seam is formed. Such incomplete weld seams are suitable for reducing excess air pressure within cavity 78 by allowing air to escape from fixture 10 toward environment 100.

[0125] Figures 13 and 14 schematically illustrate another embodiment of the medical instrument 10. In this embodiment, the medical instrument 10 comprises a handle portion 34 and a tool portion 36 connected thereto. The design of the handle portion 34 substantially corresponds to the handle portion structure described in Figures 1 and 4 to 12, but differs in the design of the proximal handle flange 66. In this embodiment, the distance between the annular surface 70 and the impact surface 18 is much greater than in the case of the proximal handle flange 66 shown and described for the embodiment of Figure 4, for example.

[0126] Proximal to annular surface 70, proximal annular flange 66 defines a transverse hole 118.

[0127] The hollow handle 32 of the embodiment shown in Figures 13 and 14 is also manufactured in a similar manner as described above in connection with Figures 1 to 11 and is selectively connected to the tool part 36. To vent the cavity 78 of the hollow handle 32, a vent opening 90 is provided, for example in the form of a bore 92 or in the form of a slit, which is closed after the instrument has been cured. Alternatively, the weld seam to form the vent opening 90 is not completely closed. The weld seam is then closed by welding after the curing process. In this embodiment, too, a final surface treatment can be performed by polishing or belt grinding. This allows, among other things, to make subsequent welding operations to close the vent opening 90 or the ventilation opening 108 invisible from the outside on the instrument 10.

[0128] As detailed above, a one-piece medical device can be formed that is highly stable and highly corrosion resistant.

[0129] All components of the different embodiments of the device 10 described above are made of metallic material, which in the described embodiment is material 1.4021. [Explanation of symbols]

[0130] 10. Equipment 12 Osteotome 14 Impact equipment 16 Proximal end 18 Impact Surface 20 Handle 22 Instrument shaft 24 distal end 26 Tool Elements 28 Cutting edge 30 Longitudinal axis 32 Hollow Handle 34 Handle 36 Tools section 38 Connection Device 40 First connecting element 42 Second connecting element 44 distal end 46 proximal end 48 Connection Receptacle 50 blind hole 52 Connection protrusion 54 Stop part 56 Annular Surface 58 Annular Surface 60 Distal Handle Flange 62 Shaft part 64 Impact Plate 66 Proximal Handle Flange 68 Annular Surface 70 Annular Surface 72 Handle shell 74 Half Shell 76 Wall 78 Cavity 80 Proximal end face 82 Distal end face 84 Flare Rim 86 Relative maximum point 88 Groove 90 Vent opening 92 bore 94 Annular Space 96 Closure Elements 98 Arrow 100 Environment 102 Thickness 104 Spacer Element 106 End 108 Ventilation opening 110 bore 112 blind hole 114 End 116 Opening 118 Side Cave 120 slit

Claims

1. A medical device (10) having a proximal end (16) and a distal end (24), a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed or formed at said distal end; an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The instrument shaft (22) includes a handle portion (34) and a tool portion (36); The handle portion (34) and the tool portion (36) are connected to each other. Medical equipment.

2. The hollow handle (32) includes two handle shells (72). The medical device according to claim 1 .

3. The cavity (78) has the form of an annular space (94).

3. The medical device according to claim 1 or 2.

4. the cavity (78) is closed by a weld and / or a closure element; A medical device according to any one of claims 1 to 3.

5. The medical device (10) has a vent opening (90); The vent opening (90) is hermetically closed. A medical device according to any one of claims 1 to 4.

6. The vent opening (90) 6. Medical device according to claim 5, characterized in that it is closed by a closure element (96) and / or by a soldering or welding.

7. The vent opening (90) characterized in that it is configured in the form of a bore (92) or a slit in at least one of said handle shells (72), The medical device according to claim 5 or 6.

8. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); At least one handle shell (72) is disposed between the proximal handle flange (66) and the distal handle flange (60) to surround the instrument shaft (72). A medical device according to any one of claims 1 to 7.

9. a distally facing annular surface (70) disposed on or formed on said proximal handle flange (66); a proximally facing annular surface (68) disposed on or formed on said distal handle flange (60); a proximal end surface (80) of at least one of the handle shells (72) facing in a proximal direction is positioned to abut the proximal handle flange (66); A distal end surface (82) of at least one of the handle shells (72) facing in a distal direction is positioned to abut the distal handle flange (60). The medical device according to claim 8 .

10. The medical device (10) is made entirely of one or more metallic materials. A medical device according to any one of claims 1 to 9, characterized in that it

11. an impact plate (64) disposed or formed at the proximal end (16) of the medical device (10), the impact plate (64) defining the impact surface (18); A medical device according to any one of claims 1 to 10, characterized in that it

12. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); The proximal handle flange (66) is disposed on or formed by the impact plate (64), or the proximal handle flange (66) forms the impact plate (64).

12. The medical device according to claim 11.

13. The medical device (10) is configured so that it cannot be disassembled without destroying the medical device (10). A medical device according to any one of claims 1 to 12, characterized in that it

14. The handle portion (34) and the tool portion (36) are inseparably connected to each other. A medical device according to any one of claims 1 to 13, characterized in that it

15. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); and the proximal handle flange (66) and the distal handle flange (60) are disposed on or formed on the handle portion (34). A medical device according to any one of claims 1 to 14, characterized in that it

16. the handle portion (34) and the proximal handle flange (66) and / or the distal handle flange (60) are of one-piece construction; 16. The medical device of claim 15.

17. The handle portion (34) and the tool portion (36) are connected to each other by a soldered or welded portion.

17. The medical device according to any one of claims 1 to 16.

18. The medical device (10) comprises a connection device (38) having a first connection element (40) and a second connection element (42); one of the first connecting element (40) and the second connecting element (42) is disposed or formed at a distal end (44) of the handle portion (34); the other of the first connecting element (40) and the second connecting element (42) is disposed or formed at a proximal end (46) of the tool portion (36); The first connecting element (40) and the second connecting element (42) in the connecting position are connected to each other.

18. Medical device according to any one of claims 1 to 17, characterized in that it

19. The first connection element (40) is configured in the form of a connection receptacle (48), and the second connection element (42) is configured in the form of a connection protrusion (52) corresponding to the connection receptacle (48).

20. The medical device of claim 18.

20. A vent opening (108) is formed on the medical device (10), the vent opening (108) being hermetically closed.

20. The medical device of claim 19.

21. The vent opening (108) is formed in the handle portion (34) or the tool portion (36).

21. The medical device of claim 20.

22. the instrument shaft (22) and / or the handle (20) and / or the tool element (26) are made of stainless steel, the stainless steel being hardenable; 22. Medical device according to any one of claims 1 to 21, characterized in that it

23. A medical device according to any one of claims 1 to 22, characterized in that the medical device (10) is a hardened component.

24. The hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22), the at least one handle shell (72) having a thickness of 0.5 mm to 2 mm.

24. Medical device according to any one of claims 1 to 23, characterized in that it

25. The medical device (10) is designed in the shape of an impact device (14).

25. Medical device according to any one of claims 1 to 24, characterized in that it

26. A method of manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The instrument shaft (22) is made up of a handle portion (34) and a tool portion (36), the handle portion (34) and the tool portion (36) being connected to each other; method.

27. said cavity (78) being in the form of an annular space (94); the cavity (78) is closed by welding and / or a closing element; 27. The method of claim 26.

28. a vent opening (90) formed in the medical device (10) fluidly connecting the cavity (78) of the hollow handle (32) to an environment (100) of the medical device (10); The vent opening (90) is hermetically closed.

28. The method according to claim 26 or 27.

29. The vent opening (90) a closure element (96), and / or is closed by soldering or welding, 29. The method of claim 28.

30. The vent opening (90) characterized in that it is configured in the form of a bore (92) or a slit in at least one of the handle shells (72), 30. The method of claim 28 or 29.

31. The vent opening (90) at least one handle shell (72) is formed by not completely welding to the instrument shaft (22) and / or at least two handle shells (72) to each other; 31. The method of any one of claims 28 to 30.

32. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); the vent opening (90) is formed by not completely welding at least one of the handle shell (72) to at least one of the proximal handle flange (66) and the distal handle flange (60); 32. The method according to any one of claims 28 to 31, characterized in that

33. The medical device (10) is characterized in that it is made entirely of one or more metallic materials.

33. The method of any one of claims 26 to 32.

34. an impact plate (64) disposed or formed at the proximal end (16) of the medical device (10), the impact plate (64) defining the impact surface (18); 34. The method of any one of claims 26 to 33.

35. The medical device (10) is configured so that it cannot be disassembled without destroying the medical device (10).

35. The method of any one of claims 26 to 34.

36. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); At least one handle shell (72) is disposed between the proximal handle flange (66) and the distal handle flange (60) to surround the instrument shaft (72).

36. The method according to any one of claims 26 to 35, characterized in that

37. a distally facing annular surface (70) disposed on or formed on said proximal handle flange (66), a proximally facing annular surface (68) disposed on or formed on said distal handle flange (60), a proximal end face (80) of at least one of said handle shells (72) disposed to abut said proximal handle flange (66), and a distal end face (82) of at least one of said handle shells (72) disposed to abut said distal handle flange (60); 37. The method of claim 36.

38. The handle portion (34) and the tool portion (36) are irremovably connected to each other.

38. The method according to any one of claims 26 to 37, characterized in that

39. a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); The proximal handle flange (66) and the distal handle flange (60) are disposed on or formed in the handle portion (34).

39. The method according to any one of claims 26 to 38, characterized in that

40. the handle portion (34) and the proximal handle flange (66) and / or the distal handle flange (60) are integrally formed; 40. The method of claim 39.

41. The handle portion (34) and the tool portion (36) are soldered or welded together.

41. The method according to any one of claims 26 to 40, characterized in that

42. an impact plate (64) disposed or formed on the proximal end (16) of the medical device (10) that defines the impact surface (18); The impact plate (64) and the handle portion (34) are formed as a one-piece member.

42. The method according to any one of claims 26 to 41, characterized in that

43. The medical instrument (10) is configured to include a connecting device (38) having a first connecting element (40) and a second connecting element (42), one of the first connecting element (40) and the second connecting element (42) being disposed or formed at a distal end (44) of the handle portion (34) and the other of the first connecting element (40) and the second connecting element (42) being disposed or formed at a proximal end (46) of the tool portion (36), and the first connecting element (40) and the second connecting element (42) being in a connecting position are connected to each other.

43. The method according to any one of claims 26 to 42.

44. The first connecting element (40) is configured in the form of a connecting receptacle (48), and the second connecting element (42) is configured in the form of a connecting protrusion (52) corresponding to the connecting receptacle (48).

44. The method of claim 43.

45. The medical device (10) is cured.

45. The method according to any one of claims 26 to 44, characterized in that

46. The medical device (10) is cured at a temperature of about 1000°C.

46. ​​The method of claim 45.

47. the instrument shaft (22) comprises a handle portion (34) and a tool portion (36), the handle portion (34) and the tool portion (36) are connected to each other, and the medical instrument (10) is cured after connecting the handle portion (34) and the tool portion (36); 47. The method according to claim 45 or 46.

48. The medical instrument (10) is cured after connecting at least one of the handle shells (72) to the instrument shaft (22).

48. The method of any one of claims 45 to 47.

49. a vent opening (90) formed in the medical device (10) fluidly connecting the cavity (78) of the hollow handle (32) to an environment (100) of the medical device (10); The vent opening (90) is closed after curing the medical device (10).

49. The method according to any one of claims 45 to 48, characterized in that

50. A vent opening (108) is formed in the medical device (10); The vent opening (108) is closed after curing the medical device (10).

50. The method according to any one of claims 45 to 49.

51. A medical device (10) having a proximal end (16) and a distal end (24), a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed or formed at said distal end; an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The medical device (10) has a vent opening (90); The vent opening (90) is hermetically closed. Medical equipment.

52. A medical device (10) having a proximal end (16) and a distal end (24), a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed or formed at said distal end; an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); At least one handle shell (72) is disposed between the proximal handle flange (66) and the distal handle flange (60) to surround the instrument shaft (72). Medical equipment.

53. A medical device (10) having a proximal end (16) and a distal end (24), a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed or formed at said distal end; an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, an impact plate (64) disposed or formed at the proximal end (16) of the medical device (10), the impact plate (64) defining the impact surface (18); Medical equipment.

54. A method of manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, a vent opening (90) formed in the medical device (10) fluidly connecting the cavity (78) of the hollow handle (32) to an environment (100) of the medical device (10); The vent opening (90) is hermetically closed. method.

55. A method of manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, a proximal handle flange (66) and a distal handle flange (60) spaced apart from the proximal handle flange (66) are disposed on or formed on the instrument shaft (22); At least one handle shell (72) is disposed between the proximal handle flange (66) and the distal handle flange (60) to surround the instrument shaft (72). method.

56. A method for manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The medical device (10) is cured; the instrument shaft (22) comprises a handle portion (34) and a tool portion (36), the handle portion (34) and the tool portion (36) are connected to each other, and the medical instrument (10) is cured after connecting the handle portion (34) and the tool portion (36); method.

57. A method for manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The medical device (10) is cured; The medical instrument (10) is cured after connecting at least one of the handle shells (72) to the instrument shaft (22). method.

58. A method of manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The medical device (10) is cured; a vent opening (90) formed in the medical device (10) fluidly connecting the cavity (78) of the hollow handle (32) to an environment (100) of the medical device (10); The vent opening (90) is closed after curing the medical device (10). method.

59. A method of manufacturing a medical device (10) having a proximal end (16) and a distal end (24), comprising: a handle (20) and a proximally facing impact surface (18) disposed on or formed at said proximal end (16); a tool element (26) disposed on or formed at said distal end (24); an instrument shaft (22) of the medical instrument (10) extending from the proximal end (16) to the tool element (26); The handle (20) is configured in the form of a hollow handle (32), the hollow handle (32) includes at least one handle shell (72) surrounding the instrument shaft (22); a cavity (78) formed between at least one of the handle shells (72) and the instrument shaft (22); The cavity (78) is hermetically closed, The medical device (10) is cured; A vent opening (108) is formed in the medical device (10); The vent opening (108) is closed after curing the medical device (10). method.

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