WO2023072947A1

WO2023072947A1 - Interchangeable adapter for coupling to an insertion device for joining and implanting prosthetic implants

Info

Publication number: WO2023072947A1
Application number: PCT/EP2022/079810
Authority: WO
Inventors: Andreas Eugen Enz; Mareike Warkentin; Detlef Behrend; Wolfram Mittelmeier; Kilian Gericke
Original assignee: Universität Rostock
Priority date: 2021-10-25
Filing date: 2022-10-25
Publication date: 2023-05-04
Also published as: DE102021127697A1

Abstract

The invention relates to an interchangeable adapter for coupling to an insertion device for joining and implanting prosthetic implants, comprising a frame (12) and an interchangeable holder (14), which is an impaction instrument for a prosthesis stem (141) on a first side and which has a ball-head locking unit (142) on the opposite second side, a shaft (15) which is rotatably mounted in the frame and mounted transverse to the interchangeable holder and the interchangeable holder is connected to the shaft in such a way that a rotation of the shaft brings about a rotation of the interchangeable holder. The object of the invention is to eliminate the disadvantages of the prior art and to provide an interchangeable adapter for impact-setting instruments, which represents an insertion combination instrument and has good handling in situ and allows a quasi-orthograde impact angle to be achieved, as well as allowing for the impact force to be measured and the impact energy to be determined in situ. The object of the invention is also quality assurance, via documentation of the data recordings during the surgery, which is carried out by means of automated logging.

Description

Interchangeable adapter for coupling to an insertion device for joining and implanting prosthetic implants

The invention relates to an interchangeable adapter for coupling to an insertion device for joining and implanting prosthetic implants.

To our knowledge, interchangeable adapters for the instrumented insertion of endoprostheses with the specially designed structural design and functioning according to the invention are not yet on the market and are also not otherwise known. So far, only proposed solutions for positioning the socket in the acetabulum are known.

In the publication DE 101 12 527 C1, a setting instrument for inserting an expansion shell into a human or animal bone, in particular a pelvic bone, is disclosed, which has a fastening device for fastening the expansion shell to the setting instrument and an adjustment device for at least essentially axial adjustment of a plate element of the setting instrument relative to the spreader shell fastened to the fastening device. During the adjustment, the plate element acts together with beveled surfaces of the expansion shell to clamp the expansion shell. Furthermore, the projection of the plate element viewed in the direction of insertion does not protrude beyond the projection of the elements of the clamped expansion shell that protrude furthest radially.

[0004] Furthermore, the publication DE 102 50 390 A1 discloses a device for setting or removing joint sockets, in particular screw sockets, of an artificial joint, in particular a hip joint, with socket connection elements that can be spread against the inside of the socket. The socket connection elements are each part of an expanding mandrel that extends over the circumference of the socket. For handling the pan, these can essentially only be non-positively connected to the inside of the pan, namely the inner peripheral wall of the pan. In the document DE102014012440A1, an instrument for setting joint sockets is disclosed, which consists of a rod-shaped setting instrument at one end of which an impact plate and at the other proximal end of a setting head are arranged. The setting head can be partially inserted into a joint socket and clamped there. The setting head consists of the socket clamping holding part with tiltable contact elements, which is placed on the housing rod, with the clamping expanding element with a cone tip being arranged so that it can be displaced centrally

Furthermore, the document DE 10 2006 043 783 A1 discloses a system which consists of a prosthetic acetabulum and a device for positioning and inserting the acetabulum into the acetabulum, whereby handling can be significantly simplified and the instrument simply in the Structure and variable in use. This object is achieved according to the invention by a system with a prosthetic acetabulum and a device for positioning and inserting this acetabulum in an acetabulum, consisting of a rod-shaped setting instrument, at the distal end of which there is an impact plate for a striking tool, and the proximal end of which is designed as a spreading element that can be inserted into a central opening of the acetabulum and clamped therein, a counter bearing plate that can be pushed onto the setting instrument from the proximal end and that can be placed on the edge of the acetabulum, the counter bearing plate having projections or grooves on the circumference that are connected to corresponding grooves or correspond to projections on the edge of the acetabulum, these being designed in such a way that a projection/groove combination enables a defined positioning of the setting instrument for the acetabulum.

In the publication DE102006049378A1 an implant, in particular an electrically passive implant is disclosed, wherein the implant at least has an RFID unit, which is coupled to a sensor for querying a sensor value.

In the publication DE102006051032A1 an invention is disclosed which represents a system and a method for determining the anchoring state of implanted endoprostheses. It is the object of the invention to propose possibilities for determining the anchoring state of implanted endoprostheses which cause reduced stress on the patient and which can deliver more precise, reproducible and comparable determination results. In the system according to the invention, a sensor suitable for measuring vibrations is also arranged on, but preferably in, the endoprosthesis. Its measurement signals can be telemetrically transmitted wirelessly using a transponder unit. The required electrical energy can also be made available inductively with the transponder unit for measuring vibration signals with the sensor, for the transmission of measuring signals and possibly also for processing and/or storing the measuring signals. A magnet or a ferromagnetic element is also present on the endoprosthesis. An alternating magnetic field is generated with an excitation coil arranged outside of the respective body with the implanted endoprosthesis. With this alternating magnetic field, vibrations are applied to the entire endoprosthesis with the aid of the magnet or ferromagnetic element. The vibrations can be detected with the sensor.

The publication DE102010003279A1 discloses a device and a method which are used to carry out in situ measurements of the anchoring strength of endoprostheses. The object of the invention is to detect the condition of the anchoring of endoprostheses in situ using sensors and to transmit the information ex vivo. Furthermore, it is the object of the invention to develop a non-invasive measurement method with which the bony anchorage of endoprostheses can be determined reliably and without radiation. The device according to the invention is characterized in that a loosening sensor is arranged in situ within the endoprosthesis and stimulates a membrane, which is arranged at the implant-bone interface, to oscillate. A measuring device measures the vibration behavior ex-vivo. For the method according to the invention, a loosening sensor inside the endoprosthesis stimulates a membrane, which is arranged on the implant-bone interface, to oscillate. A measuring device measures the vibration behavior ex-vivo, with the measured vibration damping being the indicator for the anchoring strength of the endoprosthesis.

US publication US2010/0204802A1 discloses an implant containing an antimicrobial agent; an activating agent for activating the antimicrobial agent; and a power source for powering the activating means. The present invention also provides a system comprising such an implant connected to a separate control means.

Document WO90/06720A1 discloses a device for detecting loosening of an implant implanted in a bone. The invention includes a vibrator to impart vibratory motion to the bone. The vibration is controlled to cause the vibratory motion to have a predetermined repetitive pattern. A pickup device to sense the vibrational motion transmitted through the composite bone implant to produce an output signal. Implant loosening is determined when the repetitive pattern of the output signal transmitted through the bone implant composite exhibits sustained oscilloscope crosstalk and/or significant spectrum analyzer secondary harmonics. A disadvantage of the prior art is that the systems are designed specifically for the manufacturer, ie a specific implantation instrument is required for each prosthesis system. So far, these have been designed to be rigid and are only suitable either for implanting the stem or for attaching the ball head. An intraoperative documentation of the implantation does not take place with these instruments. Neither the force nor the direction of the force are recorded. The tight fit of the implant components can only be verified through the subjective experience of the surgeon.

In the prior art for the instrumented insertion of endoprostheses with the specially designed structural design according to the invention and not on the market and otherwise not known. So far, only proposed solutions for positioning the socket in the acetabulum are known.

Presentation of the invention

It is therefore the object of the invention to eliminate the disadvantages of the prior art and to provide an interchangeable adapter for percussion instruments, which represents an insertion combination instrument and is easy to handle in situ and allows a quasi-orthograde impact angle to be implemented, as well as the measurement and determination of the percussion force which enables impact energies in situ.

[0015] It is also the object of the invention to improve quality assurance by documenting the data recordings during the operation, this is done by automated logging.

[0016] This object is achieved by the features listed in the claims.

[0017] According to various embodiments, the interchangeable adapter according to the invention has for coupling to an insertion device for joining and implanting prosthetic implants, the following components: a coupling point for connecting the interchangeable adapter to the insertion device, the coupling point being arranged on a frame. Furthermore, the interchangeable adapter has an interchangeable receptacle, which is elongate and has two sides. The interchangeable adapter is designed on a first side in such a way that it is an impaction instrument for a prosthesis stem and has a ball head locking unit on the opposite second side. Furthermore, the interchangeable adapter has an axis which is rotatably mounted in the frame, the axis being mounted transversely to the interchangeable receptacle and the interchangeable receptacle being connected to the axis in such a way that when the axis rotates, the interchangeable receptacle rotates.

[0018] According to various embodiments, the interchangeable adapter has a sensor unit and/or a control unit. The sensor unit preferably has at least one force sensor. By means of the sensor unit in connection with a control unit and/or evaluation unit, a continuous check and documentation and the possibility of adapting the application of force and the positioning of an implant in the bone can take place. The force sensor is preferably arranged on the frame. Furthermore, the force sensor is preferably a temperature-compensating semiconductor strain gauge bridge.

According to various embodiments, the coupling point of the adapter according to the invention has part of a bayonet lock. The other part of the bayonet lock is therefore located on the insertion device.

Furthermore, the frame of the interchangeable adapter according to the invention has an opening which is located on the opposite side of the coupling point. The interchangeable pickup can be guided out of the frame through the opening, either with the Impactor for a prosthesis stem on the first side of the interchangeable receiver or with the ball head locking unit on the second side of the interchangeable receiver.

According to various embodiments, the frame has at least two guide rails, which are aligned parallel to a longitudinal axis L of the interchangeable pickup, the rotatable axis being mounted in the guide rails. Preferably, the guide rails each have a sliding block, the sliding blocks being designed in such a way as to enable a rotary movement of the axle in the frame and thus a rotary movement of the interchangeable adapter in the frame, and the sliding blocks being designed in such a way that the axis slides vertically, i.e. parallel to the longitudinal axis of the interchangeable adapter to allow within the framework. This rotary movement changes the sides of the interchangeable pick-up.

The frame is preferably made of a titanium alloy, the titanium alloy being TiAL6V4.

According to various embodiments, the frame has a handle made of elastomers and/or biocompatible silicones. Embodiments include, in particular, fabrications from silicone or polyetherurethane elastomers with a Shore hardness in the range between 80 and 90 A and a shape which has ergonomic gripping recesses. The interchangeable adapter according to the invention preferably has a surface coating with a microbicidal effect, this surface coating having, for example, copper and/or silver preparations. However, other surface coatings are conceivable.

[0024] According to various embodiments, the sensor unit has a position control unit. The position control unit preferably has at least one camera, which is a CCD stereo camera, for example. According to various embodiments, the coupling point, which realizes the connection between a device for the instrumented insertion of endoprostheses and the interchangeable adapter, is a bayonet catch or a plug-in system for receiving a lockable interchangeable head. Other coupling options are conceivable.

Furthermore, according to various embodiments, the interchangeable receptacle as a component of the interchangeable adapter has a shape that can be divided into two areas according to its function, the interchangeable receptacle having the shape of a shaft, which is designed at its distal ends in such a way that one The first side of the interchangeable receptacle has a shape which is an impaction instrument for a prosthesis stem and a second side which is similar to a hemispherical shell and is a negative for a ball head attachment of an endoprosthesis and a joining instrument for endoprostheses.

The frame has an opening that causes the preferred side of the interchangeable receptacle to exit out of the frame structure. Furthermore, the frame has the shape of a ring and frames the components of the interchangeable adapter and, thanks to its open structure, allows the interchangeable receptacle to be turned around and exited manually.

According to various embodiments, the coupling point is preferably arranged on the opposite side of the opening.

Furthermore, the frame is preferably made of titanium alloys, other materials are conceivable that meet the mechanical requirements and the requirements of biocompatibility, a TIAI6V4 alloy is preferred.

According to various embodiments, the frame has a handle made from elastomers and/or biocompatible silicones, embodiments including particular fabrications made of silicone or polyetherurethane elastomers with a Shore hardness in the range between 80 and 90 A, other materials and/or composite materials being conceivable. Furthermore, the handle preferably has ergonomically designed troughs, with other design embodiments being conceivable.

According to various embodiments, a surface coating with a microbicidal effect is provided, these surface coatings preferably being copper and/or silver preparations.

Also located on the frame is a position control unit, which is preferably a camera, in particular a CCD stereo camera. The information and data collected are forwarded to an evaluation unit, the coupling or data transmission between the position control unit and the evaluation unit preferably takes place wirelessly.

According to various embodiments, the force sensor is at least one temperature-compensating semiconductor strain gauge bridge. However, the use of other measuring systems is conceivable. The measured signals are preferably transmitted wirelessly to an evaluation unit.

An advantage of the exchange adapter according to the invention for coupling to insertion devices is the possibility of correct placement of the endoprosthesis stem, taking into account the given anatomical conditions, and prevents typical complications during the implantation of hip endoprostheses such as fractures of the bed-forming bones or complications due to dislocation of the prosthesis parts Cause of misplaced or misfitted components. After the hip stem has been implanted, the interchangeable adapter can also be used to securely attach the ceramic head component to the cone of the prosthesis stem in accordance with the manufacturer's instructions. The invention also achieves a shorter operating time. Due to the significant Shortening the incision suture time also greatly reduces the perioperative risk for the patient, thus reducing the risk of infection. The anesthesia can be carried out much more gently and for a shorter time, which leads to a shorter recovery phase and also makes surgical treatment accessible to patients with central neurological or cognitive impairments (e.g. Parkinson's disease or dementia syndrome).

The invention is designed in such a way that it is suitable for various surgical access routes to the hip joint, for example from behind, from the side, from the front side or from the front, so the surgeon is free in his access and implant selection. In the case of obese or muscular patients, a quasi-orthograde application of force can be achieved using the interchangeable adapter. This can reduce the complication rate. Using the distance sensors and two CCD cameras, the relative movement of the stem in relation to the femoral shaft is stereotactically measured intraoperatively in real time. This will ensure proper stem placement.

[0036] So far, the impact energy introduced has neither been measured nor documented.

The same applies to force measurement and data transmission/documentation. The exact measurement and documentation of the impulse impact can be used to draw conclusions about the sinking depth per impulse, a statement about the existing bone quality and an adjustment of the impulse to avoid a fracture. In the case of urgent or emergency operations, the invention can be used across manufacturers, resulting in an increase in patient safety.

According to various embodiments, an insertion device for implanting and / or adding prosthetic Implants have a cylindrical housing, with at least one energy store for storing mechanical and/or electrodynamic energy, at least one firing pin for transferring the stored mechanical energy from the energy store to a coupling point, and at least one locking device (having a triggering device) being arranged in the housing . The locking device is designed in such a way that it holds the firing pin in a fixed position. The firing pin is arranged in the cylindrical housing in such a way that a first end of the firing pin protrudes and/or can be led out of the housing at an opening in the end face of the housing. Furthermore, the second end of the firing pin is coupled to the energy store and/or the locking device in such a way that when the triggering device is actuated, a force and/or energy is transmitted from the energy store to the firing pin. The firing pin has the coupling point, which is designed to accommodate a lockable ball head and/or to accommodate an interchangeable adapter. The coupling point is located at the first end of the firing pin. Furthermore, the insertion device has a sensor unit, wherein the sensor unit has at least one distance sensor.

According to various embodiments, the energy store is a spiral spring unit and/or a linear motor unit.

[0040] According to various embodiments, the insertion device has an input unit for setting a force on the energy store, which force is to be transmitted via the firing pin.

Furthermore, according to various embodiments, the insertion device has a status display which indicates a status of the locking device, a status indicating a fixing position of the firing pin and/or a released position of the firing pin and/or a force set in the fixing position. [0042] Furthermore, according to various embodiments, the insertion device has a processor unit for evaluating the recorded parameters of the sensor unit and/or for controlling the energy storage unit and/or for controlling the insertion device.

According to various embodiments, the insertion device has components for guiding the firing pin, these components preferably comprising an elastomer-buffered coupling disk and/or a coupling ring, a front stop element, an elastomer ring seal, an abutment and/or an axial plain bearing. Other components for safe guidance of the firing pin are conceivable.

According to various embodiments, the housing of the insertion device is encased with a handle, for example with elastomer grip recesses. Another embodiment of a handle is conceivable.

One embodiment of a locking device is the use of a locking pawl with a toggle latch. However, other possible configurations are conceivable.

[0046] According to various embodiment variants, the distance sensor of the sensor unit is a laser distance sensor and/or an ultrasonic distance sensor.

[0047] According to various embodiments, the coupling point can have a bayonet catch for coupling the firing pin to the interchangeable adapter and/or for receiving the ball head.

In one embodiment of the insertion device with a spiral spring as an energy store, the insertion device can have a device by means of which a spring deflection and/or the force of the spiral spring of the energy store is set manually. This device can For example, have a rotatable outer ring, which is designed such that upon actuation of this can change the spring travel.

An advantage of the device according to the invention for the instrumented insertion of endoprostheses in combination with the possibility of changing over the coupling point is the exact and time-saving positioning, which makes it possible to optimally align the medullary cavity depot to the prosthetic requirements. Therefore, the invention combines the simple surgical access with extensive avoidance of soft tissue damage and thus results in a reduction of the wound area, which means faster convalescence for the patient due to less muscle trauma and less blood loss. Due to the significant reduction in the incision and suture time, the perioperative risk for the patient is also greatly reduced, thus reducing the risk of infection and the anesthesia can be carried out much more gently and shorter, which leads to a shorter recovery phase and also patients with central neurological or cognitive impairments (e.g. Parkinson's disease or dementia syndrome) make surgical care accessible. Furthermore, a more precise positioning of the hip stem can be achieved by the invention, which results in less wear and thus a longer service life of the prosthesis and leads to an increase in patient safety. The insertion device according to the invention in connection with the possibility of connecting an interchangeable adapter to the insertion device makes it suitable for various surgical access routes to the hip joint, for example from behind, from the side, from the front or from the front. The surgeon is therefore free in his choice of access and implant. In the case of obese or muscular patients, a quasi-orthograde application of force can be achieved using an interchangeable adapter. This can reduce the complication rate. By means of the distance sensors, a measurement of the relative movement of the stem in relation to the intraoperative real time takes place Femoral shaft, this ensures correct placement of the shaft. The achieved reproducibility and documentation of the impulse shock via the sensor unit in connection with a processor unit can be used to draw conclusions about the sinking depth per impulse, a statement about the existing bone quality and an adjustment of the impulse to avoid a fracture.

The invention is designed in such a way that it is suitable for various surgical access routes to the hip joint, for example from behind, from the side, from the front or from the front, so the surgeon is free in his access and implant selection. In the case of obese or muscular patients, a quasi-orthograde application of force can be achieved using the interchangeable adapter. This can reduce the complication rate.

[0051] So far, the introduced impact energy has neither been measured nor documented.

[0053] The object is also achieved by a system consisting of an interchangeable adapter for coupling to an insertion device for joining and implanting prosthetic implants according to claim 1, and consisting of an insertion device for joining and implanting prosthetic implants. implementation of the invention

The invention is explained in more detail using one or more exemplary embodiments. For this purpose, FIG. 1 shows a longitudinal section of an interchangeable adapter,

Figure 2 top view of an interchangeable adapter,

Figure 3 longitudinal section of an insertion device of a first embodiment,

FIG. 4 longitudinal section of an insertion device of a first embodiment variant.

In the description, reference is made to the accompanying drawings, in which is shown by way of illustration specific embodiments in which the assembly of the invention may be practiced. In this regard, directional terminology such as "up," "down," etc. is used with reference to the orientation of the described drawings. The directional terminology is used for purposes of illustration and is in no way limiting.

It is understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. It is understood that the features of the various exemplary embodiments described herein can be combined with one another unless specifically stated otherwise. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

Throughout this specification, the terms "connected,""connected," and "coupled" are used to describe both a direct and an indirect connection (e.g., ohmic and/or electrically conductive, eg in an electrically conductive connection), a direct or indirect connection and a direct or indirect coupling.

In the figures, identical or similar elements are provided with identical reference symbols, insofar as this is appropriate.

According to various embodiments, the term "coupled" or "coupling" can be understood in the sense of a mechanical, hydrostatic, thermal and/or electrical connection. According to various embodiments, "coupled" can be understood in the sense of a mechanical (physical or physical) coupling. A clutch may be configured to transmit mechanical interaction (e.g., force, torque).

[0060] FIG. 1 shows an interchangeable adapter according to the invention in longitudinal section. The interchangeable adapter 10 according to the invention is designed in such a way that it can be coupled to an insertion device 0 for joining and implanting prosthetic implants. For this purpose, the interchangeable adapter 10 according to the invention has a coupling point 11 for connecting the interchangeable adapter 10 to an insertion device 0 , the coupling point 11 being arranged on a frame 12 of the interchangeable adapter 10 . Furthermore, the interchangeable adapter 10 has an interchangeable receiver 14 which is designed on a first side in such a way that it is an impaction instrument for a prosthesis stem 141 and has a ball head locking unit 142 on the opposite second side. Furthermore, an axis 15 is rotatably mounted in the frame 12, which is mounted transversely to the interchangeable holder 14 and the interchangeable holder 14 is connected to the axis 15 in such a way that when the axis 15 rotates, the interchangeable holder 14 rotates.

According to various embodiments, the interchangeable adapter 10 has a sensor unit 16 and/or a control unit (not shown here). and/or an evaluation unit (not shown here). The sensor unit and/or the control unit and/or the evaluation unit are used for continuous checking and documentation and the possibility of adapting a force application and positioning of an implant in the bone. For this purpose, the sensor unit 16 has at least one force sensor 161, the force sensor 161 and/or the sensor unit 16 preferably being/are arranged on the frame 12.

The interchangeable adapter 10 has a coupling point 11 for connection to an insertion device 0. The coupling point has a plug-in or rotary connection, preferably with a locking mechanism. For example, the coupling point can be designed in the form of a bayonet catch, so that part of the bayonet catch is arranged at the coupling point of the interchangeable adapter and the counterpart is arranged on the insertion device.

According to various embodiments, the frame 12 has an opening 121 which is located on the opposite side of the coupling point 11 . This serves to guide the interchangeable receiver 14 out of the frame 12, either with the impactor for a prosthesis stem 141 or with the ball head locking unit 142.

According to various embodiments, at least two guide rails 122 are arranged on the frame 12, which are aligned parallel to a longitudinal axis L of the interchangeable receptacle 14, the rotatable axis 15 being mounted in the guide rails 122. Furthermore, a sliding block 123 is arranged in each of the guide rails 122 , the sliding blocks 123 being designed in such a way as to enable a rotary movement of the axis 15 in the frame 12 and thus a rotary movement of the interchangeable pickup 14 in the frame 12 . Furthermore, the sliding blocks 123 are designed in such a way that the axis 15 can slide vertically in the frame 12 . FIG. 1 shows a longitudinal section according to the invention of a preferred embodiment of the interchangeable adapter for percussion instruments. According to various embodiments, the interchangeable adapter for percussion setting instruments has the following components: a coupling point 11 for connecting the interchangeable adapter to a device for instrumented insertion of endoprostheses, a frame 12, with at least two guide rails 122, each with a sliding block 123, being arranged in the frame 12, at least one Opening 121 in the frame 12, at least one force sensor 161 of a sensor unit 16, which is arranged on the frame 12, an interchangeable transducer 14 with an impaction instrument for a prosthesis stem 141 and an exchangeable ball head impactor 142, with the interchangeable transducer 4 being connected to an axis 15, the axis 15 lying horizontally via the at least one sliding block 123 can be displaced vertically in the guide rail, and a position control unit 162 of a sensor unit 16.

As shown in FIG. 1, the interchangeable receptacle 14 has the shape of a shaft. Furthermore, the impaction instrument for an endoprosthesis 141 is located on one side of the exchangeable receiver 14 and an exchangeable ball head impactor 142 is located on the opposite side.

According to various embodiments and as shown in Figure 1, an opening 121 is positioned on one side of the frame 12 such that it is preferably on the opposite side of the coupling point 11, the opening 121 allowing the exit of the interchangeable pickup 14, which having the impaction instrument 141 for a prosthesis stem and the exchangeable ball head impactor 142.

The frame 12 is preferably made of a titanium alloy, in particular TiAL6V4, other materials being conceivable. As shown in FIG. 1, according to various embodiments, there are two guide rails 122 in the frame 12, which are arranged vertically. Within each of these guide rails 122 , a sliding block 123 is gripped with low friction, which implements a vertical sliding movement, the sliding block receiving the axis 15 and rotating the interchangeable pickup 14 around the axis 15 .

According to various embodiments and as shown in FIG. 1, there is a handle 19 on the frame 12. The handle 19 is preferably made of elastomers and/or biocompatible silicones, in particular silicone or polyetherurethane elastomers with a Shore hardness in the range between 80 and 90 A

According to various embodiments and as shown in FIG. 1, the handle 19 has ergonomic recessed grips.

According to various embodiments, there is a microbicidal coating on the surfaces.

According to various embodiments, microbicidal surface coatings are preferably copper and/or silver preparations.

As shown in FIGS. 1 and 2, a position control unit 162 is located on the frame 12, preferably next to the opening 121. According to various embodiments, the position control unit 162 is a camera, in particular a CCD stereo camera.

According to various embodiments and as shown in FIG. 1, at least one force sensor 161 is located on the frame 12. The force sensor 161 is preferably a temperature-compensating semiconductor strain gauge bridge. In FIG. 2, a top view according to the invention of a preferred embodiment of the interchangeable adapter 10 for percussion setting instruments/insertion devices 0 is disclosed.

FIG. 2 shows the top view of the interchangeable adapter 10 and thus the side of the invention facing the patient.

As shown in Figure 2, the top view of the impactor for a prosthesis stem 141 is in the center of the figure.

As shown in FIG. 2 and according to various embodiments, the opening 123 is arranged on the frame 12 in such a way that the interchangeable receptacle 14 can be guided out through the opening 121 .

As shown in FIG. 2, on the side facing the patient, there is a position control unit 162, which according to various embodiments is a camera, in particular a CCD stereo camera.

FIG. 3 shows a longitudinal section according to the invention of a preferred embodiment of the device for the instrumented insertion of endoprostheses.

The insertion device according to the invention for joining and implanting prosthetic implants has a cylindrical housing 1 . At least one energy store 2 for storing mechanical and/or electrodynamic energy, at least one firing pin 3 for transferring the stored mechanical energy from the energy store 2 to a coupling point 5, and at least one locking device 4 having a triggering device 41 are arranged in the housing 1. The locking device 4 is designed and connected to the firing pin in such a way that the firing pin is held in a fixed position when the locking device 41 is used. The firing pin 3 is so in the cylindrical Housing 1 is arranged such that a first end 31 of the firing pin 3 protrudes from an opening in the end face of the housing 1 from the housing 1 and/or can be led out. At its second end 32, the firing pin 3 is coupled to the energy store 2 and/or the locking device 4 in such a way that when the triggering device 41 is actuated, the locking device 4 releases the fixing position of the firing pin and thereby a transmission of force and/or energy from the energy store the firing pin 3 takes place. Furthermore, the firing pin 3 has at least the coupling point 5, which is designed to accommodate a lockable ball head and/or to accommodate an interchangeable adapter 10, with the coupling point 5 being arranged on the first end 31 of the firing pin 3. Furthermore, the insertion device 0 has a sensor unit 6 , the sensor unit having at least one distance sensor 61 .

As shown in FIG. 3, the energy storage device 2 can be a spiral spring unit 21 .

As shown in FIG. 4, the energy store 2 can be a linear motor unit 22 .

[0085] According to various embodiments, the insertion device has an input unit for setting a force on the energy store 2, which force is to be transmitted via the firing pin. An input unit can have, for example, a rotatable outer ring, by means of which a spring deflection and/or the force of the spiral spring 21 of the energy store 2 is set manually. However, the input unit can also take place via a user interface, so that settings can also be made digitally. It is also conceivable that settings are made automatically by stored values for the patient and/or the implants used in the processor unit. According to various embodiments, the insertion device 0 according to the invention has a status display 8 which indicates a status of the locking device 4, a status indicating a fixed position and/or a released position and/or a force set in the fixed position.

Furthermore, the insertion device preferably has a processor unit for evaluating and documenting the recorded parameters of the sensor unit 6 and/or for controlling the energy storage unit 2 and/or for controlling the insertion device 1.

According to various embodiments, the insertion device has components for guiding the firing pin 3. These components preferably include at least one elastomer-buffered coupling disk 31 and/or a coupling ring 31, a front stop element 32, an elastomer ring seal 33, an abutment 34 and/or a axial sliding bearing 35.

The housing 1 of the insertion device 0 is preferably encased with elastomer grip recesses 11, as shown in Figures 3 and 4.

The locking device 4 can, for example, comprise a locking claw with a toggle lever locking hook. Other variants for locking the energy store 2 are conceivable.

Reference sign

0 insertion device

1 housing

2 energy storage

21 coil spring unit

22 linear motor unit

3 firing pins

31 first end

32 second end

33 coupling disc / coupling ring

34 front stop element

35 elastomer ring seal

36 abutments

37 axial plain bearing

4 locking device

41 release device

5 coupling point

6 sensor unit

61 distance sensor

7 status display

8 opening

10 interchangeable adapters

11 coupling point

12 frames

121 guide rail

122 sliding block

123 opening

14 interchangeable pickups 141 Impactor for a prosthetic stem

142 interchangeable ball head impactor/ ball head locking unit axis sensor unit

161 force sensor

162 position control unit

Claims

25 claims

1. Interchangeable adapter (10) for coupling to an insertion device (0) for joining and implanting prosthetic implants, having a coupling point (11) for connecting the interchangeable adapter (10) to an insertion device (0), the coupling point (11) being on a Frame (12) is arranged, further having an interchangeable receiver (14) which is designed on a first side in such a way that it is an impaction instrument for a prosthesis stem (141) and on the opposite second side has a ball head locking unit (142), an axis ( 15) which is rotatably mounted in the frame (12), wherein the axis (15) is mounted transversely to the interchangeable pickup (14) and the

Interchangeable receptacle (14) is connected to the axle (15) in such a way that when the axis (15) rotates, the interchangeable receptacle (14) is rotated.

2. Interchangeable adapter (10) according to claim 1, further comprising a sensor unit (16) and/or a control unit for the continuous checking and documentation and adjustment possibility of a force application and positioning of an implant in the bone.

3. Interchangeable adapter (10) according to claim 2, characterized in that the sensor unit (16) has at least one force sensor (161).

4. Interchangeable adapter (10) according to claim 3, characterized in that the force sensor is arranged on the frame (12).

5. interchangeable adapter (10) according to any one of the preceding claims, characterized in that the coupling point (11) has part of a bayonet lock.

6. interchangeable adapter (10) according to any one of the preceding claims, characterized in that the frame (12) has an opening (121) which is located on the opposite side of the coupling point (11), for Extract the interchangeable receiver (14) from the frame with either the impactor for a prosthesis stem (141) or the ball head locking unit (142). Interchangeable adapter (10) according to one of the preceding claims, characterized in that the frame (12) has at least two guide rails (122) which are aligned parallel to a longitudinal axis (L) of the interchangeable receiver (14), wherein in the guide rails (122) the rotatable axis (15) is mounted. Interchangeable adapter (10) according to Claim 7, characterized in that the guide rails (122) each have a sliding block (123), the sliding blocks (123) being designed in such a way that a rotary movement of the axle (15) in the frame (2) and thus a rotary movement of the interchangeable receiver (14) in the frame (12) and wherein the sliding blocks (123) are designed in such a way as to enable a sliding movement of the axis (5) vertically in the frame (2). Interchangeable adapter (10) according to one of the preceding claims, characterized in that the frame (12) has a handle (124). Interchangeable adapter (10) according to Claim 2, characterized in that the sensor unit (16) has a position control unit (161). Interchangeable adapter (10) according to Claim 13, characterized in that the position control unit (161) has a camera. Interchangeable adapter (10) according to Claim 14, characterized in that the camera is a CCD stereo camera. Interchangeable adapter (10) according to Claim 3, characterized in that the force sensor (161) is at least one temperature-compensating semiconductor strain gauge bridge.