WO2023072947A1 - Adaptateur interchangeable destiné à être accouplé à un dispositif d'insertion pour assembler et implanter des implants prothétiques - Google Patents

Adaptateur interchangeable destiné à être accouplé à un dispositif d'insertion pour assembler et implanter des implants prothétiques Download PDF

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Publication number
WO2023072947A1
WO2023072947A1 PCT/EP2022/079810 EP2022079810W WO2023072947A1 WO 2023072947 A1 WO2023072947 A1 WO 2023072947A1 EP 2022079810 W EP2022079810 W EP 2022079810W WO 2023072947 A1 WO2023072947 A1 WO 2023072947A1
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WO
WIPO (PCT)
Prior art keywords
interchangeable
frame
interchangeable adapter
adapter
insertion device
Prior art date
Application number
PCT/EP2022/079810
Other languages
German (de)
English (en)
Inventor
Andreas Eugen Enz
Mareike Warkentin
Detlef Behrend
Wolfram Mittelmeier
Kilian Gericke
Original Assignee
Universität Rostock
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Filing date
Publication date
Application filed by Universität Rostock filed Critical Universität Rostock
Publication of WO2023072947A1 publication Critical patent/WO2023072947A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4628—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A61F2002/4662—Measuring instruments used for implanting artificial joints for measuring penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A61F2002/4666—Measuring instruments used for implanting artificial joints for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4681—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by applying mechanical shocks, e.g. by hammering
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4688—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means
    • A61F2002/469—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4688—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means
    • A61F2002/4698—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means magnetic

Definitions

  • 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.
  • a setting instrument for inserting an expansion shell into a human or animal bone, in particular a pelvic bone 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.
  • the plate element acts together with beveled surfaces of the expansion shell to clamp the expansion shell.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • an invention 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.
  • 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.
  • 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.
  • the interchangeable adapter 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.
  • 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.
  • 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.
  • the interchangeable adapter has a sensor unit and/or a control unit.
  • the sensor unit preferably has at least one force sensor.
  • the force sensor is preferably arranged on the frame.
  • the force sensor is preferably a temperature-compensating semiconductor strain gauge bridge.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the coupling point is preferably arranged on the opposite side of the opening.
  • 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.
  • 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.
  • the handle preferably has ergonomically designed troughs, with other design embodiments being conceivable.
  • a surface coating with a microbicidal effect is provided, these surface coatings preferably being copper and/or silver preparations.
  • 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.
  • the force sensor is at least one temperature-compensating semiconductor strain gauge bridge.
  • 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.
  • 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.
  • a quasi-orthograde application of force can be achieved using the interchangeable adapter. This can reduce the complication rate.
  • 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.
  • 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.
  • the invention can be used across manufacturers, resulting in an increase in patient safety.
  • 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.
  • 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.
  • the insertion device has a sensor unit, wherein the sensor unit has at least one distance sensor.
  • the energy store is a spiral spring unit and/or a linear motor unit.
  • 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.
  • 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.
  • 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.
  • 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.
  • the housing of the insertion device is encased with a handle, for example with elastomer grip recesses.
  • a handle for example with elastomer grip recesses.
  • Another embodiment of a handle is conceivable.
  • a locking device is the use of a locking pawl with a toggle latch.
  • other possible configurations are conceivable.
  • the distance sensor of the sensor unit is a laser distance sensor and/or an ultrasonic distance sensor.
  • the coupling point can have a bayonet catch for coupling the firing pin to the interchangeable adapter and/or for receiving the ball head.
  • 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.
  • 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.
  • a quasi-orthograde application of force can be achieved using the interchangeable adapter. This can reduce the complication rate.
  • 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.
  • the invention can be used across manufacturers, resulting in an increase in patient safety.
  • 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.
  • FIG. 1 shows a longitudinal section of an interchangeable adapter
  • FIG. 1 top view of an interchangeable adapter
  • FIG. 4 longitudinal section of an insertion device of a first embodiment variant.
  • connection e.g., ohmic and/or electrically conductive, eg in an electrically conductive connection
  • direct or indirect connection e.g., a direct or indirect connection and a direct or indirect coupling
  • Coupled 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).
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • the sliding blocks 123 are designed in such a way that the axis 15 can slide vertically in the frame 12 .
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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
  • the handle 19 has ergonomic recessed grips.
  • microbicidal coating on the surfaces.
  • microbicidal surface coatings are preferably copper and/or silver preparations.
  • a position control unit 162 is located on the frame 12, preferably next to the opening 121.
  • the position control unit 162 is a camera, in particular a CCD stereo camera.
  • 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.
  • 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.
  • the top view of the impactor for a prosthesis stem 141 is in the center of the figure.
  • 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 .
  • 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.
  • 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.
  • 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.
  • the insertion device 0 has a sensor unit 6 , the sensor unit having at least one distance sensor 61 .
  • the energy storage device 2 can be a spiral spring unit 21 .
  • the energy store 2 can be a linear motor unit 22 .
  • 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.
  • 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.
  • the insertion device 0 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un adaptateur interchangeable destiné à être accouplé à un dispositif d'insertion pour l'assemblage et l'implantation d'implants prothétiques, comprenant un cadre (12) et un support interchangeable (14), qui est un instrument d'impact pour une tige de prothèse (141) sur un premier côté et qui a une unité de verrouillage de tête sphérique (142) sur le second côté opposé, un arbre (15) qui est monté rotatif dans le cadre et monté transversalement au support interchangeable et le support interchangeable est relié à l'arbre de telle sorte qu'une rotation de l'arbre entraîne une rotation du support interchangeable. L'objet de l'invention est d'éliminer les inconvénients de l'état de la technique et de fournir un adaptateur interchangeable pour des instruments de réglage d'impact, qui représente un instrument de combinaison d'insertion et a une bonne manipulation in situ et permet d'obtenir un angle d'impact quasi-orthograde, ainsi que pour permettre la mesure in situ de la force d'impact à mesurer et de l'énergie d'impact. L'objet de l'invention est également l'assurance qualité, par l'intermédiaire de la documentation des enregistrements de données lors de la chirurgie, qui est réalisée au moyen d'une diagraphie automatisée.
PCT/EP2022/079810 2021-10-25 2022-10-25 Adaptateur interchangeable destiné à être accouplé à un dispositif d'insertion pour assembler et implanter des implants prothétiques WO2023072947A1 (fr)

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Application Number Priority Date Filing Date Title
DE102021127697.7 2021-10-25
DE102021127697.7A DE102021127697A1 (de) 2021-10-25 2021-10-25 Wechseladapter zur Ankopplung an eine Insertionsvorrichtung zum Fügen und Implantieren prothetischer Implantate

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WO2023072947A1 true WO2023072947A1 (fr) 2023-05-04

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Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990006720A1 (fr) 1988-12-21 1990-06-28 Rosenstein Alexander D Procede et appareil de determination de l'integrite de fixation d'un implant osseux
DE10112527C1 (de) 2001-03-15 2002-10-10 Mathys Medizinaltechnik Ag Bet Setzinstrument zum Einbringen einer Spreizschale
DE10250390A1 (de) 2002-10-29 2004-05-13 Plus Endoprothetik Ag Gerät zum Setzen oder Entfernen von Gelenkpfannen, insbesondere eines künstlichen Hüftgelenks
US20070293949A1 (en) * 2004-10-08 2007-12-20 Salerni Anthony A Interior connecting interbody cage insertional tools, methods and devices
DE102006043783A1 (de) 2006-09-13 2008-03-27 Aap Implantate Ag System mit einer prothetischen Hüftgelenkpfanne und einer Vorrichtung zum Positionieren dieser Hüftgelenkpfanne in einem Acetabulum
DE102006049378A1 (de) 2006-10-19 2008-04-24 Siemens Ag Implantat mit RFID-Einheit
DE102006051032A1 (de) 2006-10-21 2008-04-30 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. System und Verfahren zur Bestimmung des Verankerungszustandes implantierter Endoprothesen
EP2097047B1 (fr) * 2006-12-28 2010-05-19 Istituto Ortopedico Galeazzi S.P.A. Instrument chirurgical destiné à simuler l'instabilité fonctionnelle de composants acétabulaires de prothèses de la hanche au cours de la phase intraopérative
US20100204802A1 (en) 2006-09-21 2010-08-12 Wilson Darren Medical device
DE102010003279A1 (de) 2009-03-27 2010-09-30 Bader, Rainer, Prof. Dr. Vorrichtung und Verfahren zur In-situ-Messung der Verankerungsfestigkeit von Endoprothesen
US20130046313A1 (en) * 2009-04-13 2013-02-21 George John Lian Systems and instrumentalities for use in removal of tibial prostheses of total ankle replacements
DE102014012440A1 (de) 2014-08-19 2016-03-10 Ohst Medizintechnik Ag Instrument zum Setzen von Gelenkpfannen
US20200121474A1 (en) * 2018-10-19 2020-04-23 Tightline Development, LLC. Hip and knee joint stem explant system and methods of using the same

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990006720A1 (fr) 1988-12-21 1990-06-28 Rosenstein Alexander D Procede et appareil de determination de l'integrite de fixation d'un implant osseux
DE10112527C1 (de) 2001-03-15 2002-10-10 Mathys Medizinaltechnik Ag Bet Setzinstrument zum Einbringen einer Spreizschale
DE10250390A1 (de) 2002-10-29 2004-05-13 Plus Endoprothetik Ag Gerät zum Setzen oder Entfernen von Gelenkpfannen, insbesondere eines künstlichen Hüftgelenks
US20070293949A1 (en) * 2004-10-08 2007-12-20 Salerni Anthony A Interior connecting interbody cage insertional tools, methods and devices
DE102006043783A1 (de) 2006-09-13 2008-03-27 Aap Implantate Ag System mit einer prothetischen Hüftgelenkpfanne und einer Vorrichtung zum Positionieren dieser Hüftgelenkpfanne in einem Acetabulum
US20100204802A1 (en) 2006-09-21 2010-08-12 Wilson Darren Medical device
DE102006049378A1 (de) 2006-10-19 2008-04-24 Siemens Ag Implantat mit RFID-Einheit
DE102006051032A1 (de) 2006-10-21 2008-04-30 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. System und Verfahren zur Bestimmung des Verankerungszustandes implantierter Endoprothesen
EP2097047B1 (fr) * 2006-12-28 2010-05-19 Istituto Ortopedico Galeazzi S.P.A. Instrument chirurgical destiné à simuler l'instabilité fonctionnelle de composants acétabulaires de prothèses de la hanche au cours de la phase intraopérative
DE102010003279A1 (de) 2009-03-27 2010-09-30 Bader, Rainer, Prof. Dr. Vorrichtung und Verfahren zur In-situ-Messung der Verankerungsfestigkeit von Endoprothesen
US20130046313A1 (en) * 2009-04-13 2013-02-21 George John Lian Systems and instrumentalities for use in removal of tibial prostheses of total ankle replacements
DE102014012440A1 (de) 2014-08-19 2016-03-10 Ohst Medizintechnik Ag Instrument zum Setzen von Gelenkpfannen
US20200121474A1 (en) * 2018-10-19 2020-04-23 Tightline Development, LLC. Hip and knee joint stem explant system and methods of using the same

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