SURGICAL APPARATUS, SURGICAL SYSTEM AND METHOD OF SETTING UP A SURGICAL APPARATUS

Abstract

A surgical apparatus generates energy that is input onto an appliance. The appliance is one of an implant to be implanted in human or animal bone tissue by the input of the energy, and of a tool being an ultrasonic bone cutting and/or punching tool for cutting and/or punching living human or animal bone tissue by input of energy onto the implant in a surgical operation. The apparatus includes a control device and at least one handpiece, the handpiece being equipped to be held by a surgeon during the operation and to couple the energy into the appliance. The apparatus further includes a reading device equipped to read out, from an appliance data carrier, appliance data dedicated to the appliance. The control device checks, depending on the appliance data, whether the handpiece is suitable for the appliance and chooses operating parameters depending on the appliance data.

Claims

1. A surgical apparatus for generating an energy input onto an appliance during a surgical operation, wherein the appliance is one of an implant to be implanted in human or animal bone tissue by the input of the energy, and of a tool being an ultrasonic bone cutting and/or punching tool for cutting and/or punching living human or animal bone tissue, the apparatus comprising a control device and at least one handpiece, the handpiece being equipped to be held by a surgeon during the operation and to couple the energy into the appliance, wherein the apparatus further comprises a reading device equipped to read out, from an appliance data carrier, appliance data dedicated to the appliance, wherein the control device is equipped and programmed to check, depending on the appliance data, whether the handpiece is suitable for the appliance, and to choose, depending on the appliance data, operating parameters for the surgical operation.

2. The apparatus according to claim 1, being equipped and programmed to extract at least a portion of the operating parameters from the appliance data.

3. The apparatus according to claim 1, being equipped to extract at least a portion of the operating parameters from a data base using an appliance type information extracted from the appliance data.

4. The apparatus according to claim 1, wherein the energy is mechanical vibration energy, and wherein the handpiece comprises a vibration generator.

5. The apparatus according to claim 1, wherein the reading device is equipped for a contactless readout process.

6. The apparatus according to claim 1, wherein the reading device is integrated in the control device.

7. The apparatus according to claim 1, wherein the reading device is integrated in a sterilizable reading device unit separate both, from the control device and from the handpiece.

8. The apparatus according to claim 1, wherein the handpiece is exchangeable, and wherein the control device is equipped to automatically identify the handpiece.

9. The apparatus according to claim 8, being equipped to output a message and/or to discontinue operation in case the handpiece is identified to be unsuitable for the appliance.

10. The apparatus according to claim 1, being equipped to have stored in a memory of the control device and/or of the handpiece wear data indicating how often the handpiece had been used before and whether a revision would be necessary.

11. The apparatus according to claim 1, further comprising an operating control device separate from the handpiece and comprising an input tool, the apparatus being equipped to activate the handpiece depending on an input on the input tool.

12. The apparatus according to claim 11, wherein the input tool is a foot petal.

13. The apparatus according to claim 1, wherein said apparatus is equipped and programmed to demand a confirmation to be inputted after an implant type of the implant has been extracted from the appliance data.

14. The apparatus according to claim 1, wherein an operating power level is adjustable by an operator, the values to which the operating power level may be set depending on the appliance data.

15. The apparatus according to claim 1, further comprising a cooling device equipped for cooling the appliance.

16. The apparatus according to claim 15, wherein a cooling power is adjustable by an operator, the values to which the operating power level may be set depending on the appliance data.

17. The apparatus according to claim 16, wherein the values to which the operating power level may be set depending on the appliance data further depend on a power level adjusted by the operator.

18. The apparatus according to claim 15, wherein the cooling power is controlled to depend on an operating power level.

19. The apparatus according to claim 1, further comprising an interface to an external computer and/or network, wherein the apparatus is configured to output data measured during operation.

20. The apparatus according to claim 19, wherein the energy is mechanical vibration energy and the handpiece comprises a vibration generator with an ultrasonic transducer, and wherein the data measured during operation comprises a feedback of a control of the ultrasonic transducer.

21. A surgical system, comprising an apparatus according to claim 1, and further comprising an appliance package containing the appliance, the system further comprising an appliance data carrier readable by the reading device, the appliance data carrier being integrated in the package being or being provided as separate item.

22. The surgical system according to claim 21 wherein the appliance data carrier is provided as separate item contained in the package.

23. The surgical system according to claim 21, wherein the appliance comprises thermoplastic material liquefiable by the energy coupled into the appliance by the handpiece.

24. The surgical system according to claim 21, wherein the reading device is separate from the handpiece.

25. The surgical system according to claim 24, wherein the reading device is integrated in the control device.

26. A method of setting up a surgical system for surgical operation, the method comprising the steps of: providing a surgical apparatus generating an energy input onto an appliance during a surgical operation, wherein the appliance is one of an implant to be implanted in human or animal bone tissue by the input of the energy, and of a tool being an ultrasonic bone cutting and/or punching tool for cutting and/or punching living human or animal bone tissue, the apparatus comprising a control device and at least one handpiece, the handpiece being equipped to be held by a surgeon during the operation and to couple the energy into the appliance; providing the appliance and an appliance data carried assigned to the appliance; reading out appliance data from the appliance data carrier, the appliance data being dedicated to the appliance; using the appliance data to check whether the handpiece is appropriate for the appliance; and configuring the apparatus for carrying out the surgical operation by setting operating parameters that depend on the appliance data.

27. The method according to claim 26, wherein setting the operating parameters comprises using operating parameter settings belonging to the appliance data as the operating parameters.

28. The method according to claim 26, wherein setting the operating parameters comprises using the appliance data to identify the appliance type and using operating parameter settings stored in a memory and assigned to the appliance type as the operating parameters.

29. The method according to claim 26, further comprising the steps of outputting information on a recognized appliance type of the appliance-; and checking whether a confirmation was inputted in response to outputting.

30. The method according to claim 29, wherein the apparatus has an operating control for activating and de-activating the handpiece, and wherein in the step of checking it is checked whether a confirmation was inputted via the operating control.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Hereinafter, embodiments of the invention are described referring to drawings. The drawings are schematical. They show:

[0081] FIG. 1 an apparatus with a control device including a reader, and with a handpiece;

[0082] FIG. 2 a scheme of elements of the apparatus; and

[0083] FIG. 3 an alternative apparatus.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0084] The apparatus shown in FIG. 1 includes a control device 1 that is connectable to a handpiece 3. The handpiece 3 for example includes a vibration generator equipped to set a sonotrode 5, 105 into mechanical installation. The electrical signal for activating the vibration generator may be supplied by the control device 1 via a connecting line 7. It may however also be possible that the control device merely transmits a command to the handpiece, and that the handpiece itself includes a control for generating the electrical signal. As yet another alternative, it would theoretically be possible that the control device 1 includes a vibration generator, and that the connecting line 7 transmits the mechanical vibration to the handpiece 3.

[0085] The apparatus further includes an operating control device 9 for the operator (i.e., generally for the surgeon). The operating control device 9 in the depicted embodiment is illustrated to be implemented as a foot operating control, especially by including a foot pedal 11. In alternative embodiments, the operating control device 9 may be present as an operating element (switch, lever or the like) of the handpiece 3. Also embodiments with a distributed operating control device including both, at least one operating element to be manipulated by foot and at least one element operated by hand are possible. Even further embodiments may include a different form of a separate operating control device.

[0086] In many embodiments, such as the depicted embodiment with a foot operating control, however, it is preferred if the person operating the handpiece also is capable of operating the operating control device. This may for example imply that the operating control device 9 is equipped to be placed in a sterile section of the operating room, i.e. remote from the—generally not sterile—control device 1. Thus, the connecting line 7 and an operating control device connecting line 13 may have a length sufficient for this; for example both, the connecting line 7 and the control device connecting line 13 may have a length of at least 2 m each. Wireless connections replacing one or both of the connecting lines are not excluded.

[0087] FIG. 1 also depicts the two categories of implants for being implanted by the device. A first category is a for example pin-shaped implant 101 including thermoplastic material at least on a portion of its surface. For example, the pin-shaped implant may consist of the thermoplastic material. For implantation, the sonotrode 5 is pressed against a proximally facing incoupling surface of the implant 101 while the implant is in contact with bone tissue and while the sonotrode 5 is subject to mechanical vibration to couple mechanical vibration energy into the implant. Due to friction between the implant and the bone tissue, the vibration energy is at least partially absorbed at the interface between the implant and the bone tissue, whereby the thermoplastic material is heated up, becomes flowable and is pressed into the bone tissue. After re-solidification, this anchors the implant in the bone tissue. See for example WO 02/069 817. A second category of implant includes a sheath element 102 with a hollow space and at least one opening through which thermoplastic material of a thermoplastic element 103 is pressable into surrounding tissue, as for example described in WO 2011/054124.

[0088] Further, FIG. 1 also depicts an alternative sonotrode 105 to be mounted to the handpiece 3, which alternative sonotrode 105 is an ultrasonic bone cutting and/or bone punching tool, for example a blade-like tool as described in the Swiss patent application 01166/18. For example, the apparatus may be equipped to support handpieces 3 for both, a sonotrode 5 for implanting an implant and for an ultrasonic bone cutting and/or punching tool. Depending on the dimensions and material parameters, it is not excluded that even a same handpiece 3 may be useable for implantation on the one hand and bone cutting/punching on the other hand.

[0089] FIG. 1 further depicts a package 21 for the appliance (implant of the first or second category or tool, depending on the planned operation) to be used, the appliance package 21 having an appliance data carrier 25 attached thereto, for example an RFID chip.

[0090] As an alternative to being present in the package, the appliance data carrier may be delivered as a separate chip card or similar, i.e. a dedicated data carrier device.

[0091] FIG. 2 shows a scheme of elements of the apparatus. The control device 1 includes an electronic control module 21 that is equipped to communicate with the handpiece 3 and as well as with the operating control device 9 (footpiece in the depicted embodiment). Further, it includes a communication interface module 23 that is capable of reading data from an external data carrier, namely for example an appliance data carrier 25.

[0092] The interface module may include a reader, such as an RFID reader 27, as schematically illustrated in FIG. 1. The reader is equipped to read out data from the appliance data carrier 25. The control device 1 may further include a display 28 and/or other user interface elements. In the embodiment of FIG. 1, the control device moreover has buttons 29 as part of the user interface. More in general, the user interface may include any suitable input and/or output means, including touch screen, etc.

[0093] The control device may further include a computer interface for communicating with an external computer and/or a web interface or the like for communicating directly with a computer network.

[0094] The appliance data carrier 25 may be attached to an appliance package or alternatively directly to an appliance. It contains appliance data containing information including at least one of: [0095] identification information unambiguously identifying the appliance type; [0096] control information containing control parameters enabling the control to control the operating process in a manner specifically adapted to the appliance type.

[0097] The appliance data carrier may have any suitable physical form, such as the form of an electronically readable data carrier, such as an integrated circuit data carrier (for example an RFID chip, i.e. an RFID transponder or RFID tag) or the form of an optically readable label (such as a QR code, barcode or other code.).

[0098] If the appliance data carrier contains information allowing the identification (ID information), optionally the control may have stored control parameters of the above-disclosed kind for different implant types. The control then may select, based on the ID information, the control parameter. The control may also be equipped for using the computer interface or web interface (or the like) for obtaining the required information from the external computer or, directly or indirectly, via a network 31, for example from a dedicated server or from a cloud. The computer interface or web interface (or the like) may also serve for outputting data on the operation, for the patient's file, for analysis by the surgeon, and/or for analysis by the manufacturer and/or operator of the apparatuses for analysis.

[0099] The handpiece 3 may include a handpiece data carrier 33 that records uses of the handpiece. Such recording may include a simple counting of operations (that may be characterized by a certain working cycle being applied) or may be more complex, for example by recording a usage time, an overall (integrated) energy or even details on each individual application. Thereby, it is possible for the control device 1 to read out wear data and to make further operation dependent thereon. In addition or as an alternative, the handpiece data carrier 33 may for example include calibration data of the handpiece to warrant a correct control of the sonotrode amplitude and/or the instrument performance.

[0100] FIG. 3 illustrates the principle that operating parameters controlled by the control device may include a cooling power. More in concrete, FIG. 3 illustrates the control device 1 connected to the handpiece 3 that carries an ultrasonic cutting tool 105 as the appliance. The handpiece is further connected to a coolant pipe 71 through which a sterile coolant (for example sterile water) is conveyed and from which the coolant 73 is sprayed (sprayhead 74) onto the cutting tool 105. A controllable pump 72 is also controlled by the control device. A controllable pump may for example be a roller pump. A separate controlling device (in addition to a controllable pump or as an alternative thereto) is possible also. The controllable pump (or other flowthrough controller) may be integrated in the control device, or be separate therefrom, as illustrated in FIG. 3

[0101] The coolant may be used for the handpiece, or the blade or both, in a serial or parallel manner. As an alternative to being sprayed onto the blade by a sprayhead, as shown in FIG. 3, it is also possible to direct the coolant through the handpiece and a cannulated sonotrode onto the blade. This latter possibility may especially be preferred if in addition to the blade also the handpiece is to be cooled.

[0102] The coolant flow controlled by the control device is dependent on the data read out from the appliance data carrier and which may, as explained hereinbefore, for example be set within limits via an input into the control device. In addition or as an alternative, (and independent of the existence of a coolant pipe) the ultrasound power may be settable within limits that depend on the data read out from the appliance data carrier, as also explained hereinbefore.

[0103] FIG. 3 also illustrates, schematically a division 81 between a sterile region in which all devices—or at least the outer surfaces of all devices—need to be sterile and a non-sterile region with the control device. If the appliance data carrier 25 is present on the package 21, the reader 27 may be in the non-sterile region.

[0104] The following process may apply for preparing the apparatus for the operation if the operation is an implantation process. [0105] In a first step, the control device 1 checks whether the operating control device 9 (if applicable) and the handpiece 3 are present, i.e. if there is a communication link to the operating control device and the handpiece, respectively. If operating control device and/or the handpiece are equipped to be connected to the control device by a physical connecting line 7; 13, then the check includes a check whether the respective connecting lines are plugged in and whether the operating control device/the handpiece are working. If at least one of the checks has a negative result (i.e. if not both, the operating control device and the handpiece are connected and in good order), the process stops and an according message is outputted via the display and/or by other means. [0106] In embodiments without a separate operating control device, the first step may include a check of the handpiece 3 only. [0107] In a second, optional step, the control device reads wear data from the handpiece and for example checks whether a stored number of working cycles implies that a revision or exchange of the handpiece is necessary. If yes, an according message is output. If not, the apparatus indicates that it is ready for the process to move on to the next step. [0108] In a third step, the appliance data (implant data) is read out. For example, to this end a person (who may be the surgeon or who may alternatively be an assisting person) holds the package (or chip card etc.) of the implant sufficiently close to the reader of the interface module. The read out step may include that the package/chip card is hold close to the reader for a certain amount of time (such as a few seconds, for example 2-5 seconds) and that after a successful readout a confirmation signal, for example an acoustic signal, is outputted. [0109] In a fourth step, based on this appliance data the control checks whether the chosen connected handpiece is suitable for the particular implant type. If not, the apparatus outputs an according message, and the process is stopped. The information about which kind of handpiece fits to the particular implant type may be stored in the control device, may be accessible by the control device from an external source, and/or may be part of the implant data. [0110] In a fifth, optional step, the apparatus carries out a self-scan of the handpiece, with or without the implant being already coupled thereto. In this self-scan for example parameters like the resonance frequency—that depends on the handpiece-implant pairing—or other specific properties are double-checked. [0111] Then (if applicable if the fifth step did not yield any irregularity) in a sixth step the operator is requested to confirm that she/he is ready, for example by an appropriate input into the operating control device (such as a double click onto the foot pedal or similar). Prior to the confirmation request, the control device may output information on the implant based on the read out data, such as the type of implant, which output information is requested to be considered by the operator before confirmation. Especially, the operator or an assisting person may be requested to read the implant type from the display and to confirm only after having knowledge of the recognized implant type. [0112] After confirmation the apparatus is ready for implantation. [0113] After or during implantation, data may be output from the control device.

[0114] Variants of this process are possible, depending on the specific requirements and the system used.

[0115] Implantation thereafter may be possible in known manner, for example as described in WO 02/069 817, WO 2011/054124 or any other publication referring to the implantation, with the aid of mechanical vibration, of an implant including thermoplastic material.

[0116] If the appliance is an ultrasonic bone cutting and/or bone punching tool, the same process may be used, wherein instead of an implant, of a certain type, in an implant package with an implant data carrier carrying implant data, a cutting/punching tool, of a certain type, in a tool package with a tool data carrier carrying tool data is used. In the fifth, optional step then the self-scan is for example carried out with the tool coupled to the handpiece.

[0117] Operation after the preparing process may be carried out for example as known from the prior art by pressing the tool against bone tissue while mechanical vibration is coupled into the tool, to locally disrupt bone tissue for cutting/punching. In embodiments, this process may be used as microfracturing process, i.e. the bone cutting and/or punching tool may be equipped to disrupt the bone tissue only superficially in order to assist a healing process, for example as described in PCT/EP2019/067749.