Medical instrument device, medical system and medical instrument with a thermochromic element

Abstract

Medical instrument device (10), in particular for use in endoscopic procedures in aqueous and / or non-aqueous solutions, comprising: - an instrument body (12) for insertion into a treatment area (13) and - a thermochromic element (14) which is arranged in and / or on the instrument body (12), wherein the thermochromic element (14) has a thermochromic transition temperature of less than 50°C.

Description

[0001] The present invention relates to a medical instrument device, in particular for use in endoscopic procedures in aqueous and / or non-aqueous solutions, a medical system, in particular a laparoscopy system, a urological endoscopy system, a gynecological endoscopy system or an arthroscopic endoscopy system, and a medical instrument.

[0002] There are known medical procedures and systems, for example in laparoscopy, urology, gynecology, or arthroscopy, that use aqueous and non-aqueous irrigation solutions. These procedures and systems may involve the application of energy, for example via laser radiation, radiofrequency (RF) energy, or ultrasound, which can lead to heating of the solutions and consequently to damage of the surrounding tissue.

[0003] US patent 2003 / 0216732 A1 discloses a medical welding device for joining two tissue sections, the claws of which are equipped with a thermochromic element to provide feedback to the treating physician regarding the temperature in the joining area. This is intended to ensure a reliably strong weld seam by maintaining a sufficiently high temperature.

[0004] From US 2008 / 0077128 A1, a device is known which includes a thermochromic temperature indicator element in electrosurgical devices.

[0005] Starting from the prior art, one object of the invention is to extend the scope of application and / or the reliability of a medical instrument device, a medical system or a medical instrument, and in particular to avoid or at least minimize thermal damage in living tissue.

[0006] This problem is solved according to the invention by a medical instrument device, a medical system and a medical instrument as described herein and defined in the claims.

[0007] One aspect of the invention relates to a medical instrument device, in particular for use in endoscopic procedures in aqueous and / or non-aqueous solutions, comprising: - an instrument body for insertion into a treatment area and - a thermochromic element which is located in and / or on the instrument body and which has a thermochromic transition temperature of less than 50°C.

[0008] The invention further relates to a medical system, in particular a laparoscopy system, a urological endoscopy system or an arthroscopic endoscopy system, comprising a medical instrument which is at least partially formed by the instrument device.

[0009] Furthermore, the invention relates to a medical instrument, comprising at least a part of the medical instrument device.

[0010] The features according to the invention advantageously expand the scope of application and / or the reliability of the application, particularly by preventing or at least minimizing thermal damage in living tissue. This preferably prevents the impairment of enzyme activity. Furthermore, hyperemic swelling can be minimized. By effectively controlling the temperature, coagulation, especially protein denaturation coagulation, and / or necrosis and / or tissue shrinkage can be advantageously avoided.

[0011] The medical instrument attachment can be a fully integrated part of the medical instrument. Alternatively, the medical instrument attachment can be only a partial part of the medical instrument. In particular, the instrument body and / or the thermochromic element can be part of the medical instrument. The medical instrument can be formed at least by the instrument body and / or the thermochromic element.

[0012] The medical system, and in particular the medical instrument device, may further comprise an image acquisition unit for capturing at least one image of the treatment area and / or an evaluation unit for evaluating an image of the treatment area.

[0013] Furthermore, the medical system, and in particular the medical instrument device, may include an energy application unit for supplying energy to the treatment area and / or a fluid pump for supplying fluid to the treatment area and / or for removing fluid from the treatment area. The fluid pump may be designed as a circulation pump for the simultaneous supply and removal of fluid.

[0014] The treatment area can be a region to be treated within a living organism, particularly within a human or an animal. The treatment area can be a cavity within the living organism and may be at least partially bounded by living tissue. The treatment area can be accessible through a body orifice, particularly an artificially created or natural one.

[0015] The aqueous and non-aqueous solutions can be irrigation solutions used, for example, in urology, during laparoscopy, arthroscopy, lithotripsy, electrosurgery, and / or laser surgery. The aqueous solution can be, for example, a saline solution, preferably a 0.9% NaCl solution. Suitable non-aqueous solutions include electrolyte-free irrigation solutions, such as Purisole® SM. The aqueous and non-aqueous solutions can fill the cavity during a procedure.

[0016] The thermochromic effect of the thermochromic element can be attributed to a structural change in at least one component, in particular a dye, of the thermochromic element and / or to a change in a lattice arrangement, in particular at least one periodic structure, of the thermochromic element. The thermochromic effect can be based on a color change and / or a change in transparency of at least one component of the thermochromic element. The thermochromic effect is preferably reversible. It is conceivable that a reflection spectrum and / or a fluorescence spectrum of the thermochromic element changes at the thermochromic transition temperature, preferably in the visible range.

[0017] The thermochromic element can be a thermochromic polymer, a thermochromic polymer matrix, a thermochromic thermoplastic, a thermochromic thermoset, a thermochromic elastomer, a thermochromic paint, and / or a thermochromic coating. Thermochromic additives can not only be stable within a polymer matrix, but they can also withstand the processing, reprocessing, and sterilization without damage.

[0018] The thermochromic element can be designed as a coating, paint, and / or print on the instrument body. Alternatively, the instrument body and the thermochromic element can be formed as a single unit. In this case, it is conceivable that the instrument body is at least partially formed from the thermochromic element and / or that the thermochromic element is embedded at least partially within the instrument body. For example, the instrument body could have or be formed from a thermochromic polymer. Preferably, the thermochromic element is arranged at least in and / or on a distal end region of the instrument body, and particularly of the medical instrument.

[0019] The instrument body can be configured as any part of a medical instrument that would be considered useful to a person skilled in the art. For example, the instrument body could be part of a scalpel, forceps, needle holder, hook, spoon, Redon stick, scissors, clamp, pliers, retractor, resectoscope loop, and / or any other instrument that would be considered useful to a person skilled in the art. In one embodiment of the invention, the instrument body can be configured as a laser fiber, enabling temperature measurement in the immediate vicinity of an energy input. Alternatively, the instrument body could be configured as a sonotrode, an electrode, an RF resectoscope loop, RF forceps, and / or as part of any other device that would be considered useful to a person skilled in the art.

[0020] The thermochromic transition temperature is preferably a few degrees Celsius above a typical body temperature of the living organism and can be at least 40°C, preferably at least 45°C and particularly preferably at least 48°C.

[0021] In one aspect of the invention, which can be considered both on its own and in combination with other aspects of the invention, the medical instrument device can have an image acquisition unit for capturing at least one image of the treatment area, which includes an image of the thermochromic element. This allows image information to be provided to a treating person, in particular a physician and / or surgeon, and / or for further processing and / or archiving.

[0022] The image acquisition unit can be specifically designed to record image data in the visible light spectrum. If the image acquisition unit is configured to record multi- and / or hyperspectral image data, particularly advantageous image information can be provided, which can include spectral information in addition to geometric information. This additional spectral information can further improve the determination of temperature and / or the detection of temperature exceedances.

[0023] The image acquisition unit can be part of an endoscope, in particular a cystoscope, hysteroscope, arthroscope, laparoscope, urological endoscope, resectoscope, and / or another endoscope that would be considered appropriate by a person skilled in the art. Alternatively, the image acquisition unit can be designed as a separate unit from and connected to an endoscope, in particular one of the aforementioned endoscopes, with the connection between the image acquisition unit and the endoscope being effected by means of a fiber optic cable.

[0024] The image acquisition unit can include at least one image sensor unit, which may be specifically designed to acquire multi- or hyperspectral image data. The image sensor unit can preferably operate according to the pushbroom principle, although alternative image acquisition methods are also conceivable, such as a whiskbroom or similar method. The image sensor unit can include a multi-color filter array for spectral resolution in a known manner.

[0025] The image sensor unit can include at least one image sensor, for example, a CMOS camera, to acquire the image data. Furthermore, it is conceivable that the image sensor unit could have different image sensors, preferably CMOS cameras, for different wavelength ranges. For example, a first image sensor could record image data in the visible light wavelength range, while a second image sensor could record image data in an infrared light wavelength range. A beam splitter element of the image sensor unit could be configured to direct incident light with the respective assigned wavelength range onto the corresponding image sensor. The image acquisition unit could include a blocking filter to block excitation light.

[0026] The medical system, and in particular the medical instrument assembly, may include a lighting unit for illuminating the treatment area. The provided illumination makes changes in the spectral properties of the thermochromic element clearly visible. Furthermore, it ensures sufficient illumination of the treatment area.

[0027] The illumination unit can be part of an endoscope, in particular one of the aforementioned endoscopes. Alternatively, the illumination unit can be designed as a separate unit connected to an endoscope, in particular one of the aforementioned endoscopes, with the connection between the illumination unit and the endoscope being effected by means of a fiber optic cable.

[0028] The lighting unit can be configured to provide visible light for illuminating the treatment area. Alternatively or additionally, the lighting unit can be configured to provide infrared light for illuminating the treatment area. Furthermore, the lighting unit can be configured to provide excitation light for fluorescence imaging. The lighting unit can have one or more light sources, whereby light from multiple light sources could be combined by means of beam splitters. In some embodiments, the lighting unit can be configured to provide different types of illumination sequentially over time.

[0029] In a further embodiment of the invention, the medical instrument device can include an evaluation unit which is configured to evaluate the image of the treatment area. This can advantageously increase the functionality of the medical system and, in particular, the medical instrument device.

[0030] The evaluation unit can be integrated into the image acquisition unit, preferably in a common device housing. The evaluation unit can be part of a control and / or regulation unit of the medical system, and in particular of the medical instrument device, which is configured to control and / or regulate at least one further function of the medical system, and in particular of the medical instrument device.

[0031] Preferably, the evaluation unit can be configured to identify the image of the thermochromic element in the image of the treatment area, thereby enabling the automation of detection of a temperature change and / or an exceedance of a temperature limit.

[0032] The evaluation unit can utilize known pattern recognition algorithms to identify the image of the thermochromic element within the image of the treatment area. Preferably, the evaluation unit can be configured to use a known shape of the thermochromic element to improve recognition.

[0033] In a preferred embodiment of the invention, the evaluation unit can be configured to infer an absolute and / or relative temperature and / or a temperature limit exceedance of the thermochromic element from the image of the thermochromic element. This can advantageously increase the operational safety and / or the reliability and / or tolerability of a medical and / or surgical procedure.

[0034] The evaluation unit can be configured to infer and / or estimate the temperature and / or temperature limit exceedance of the thermochromic element based on a change in spectral properties, particularly a color change, of the image of the thermochromic element. It is particularly advantageous if the image acquisition unit is configured to acquire multispectral and / or hyperspectral image data, as this can significantly increase detection accuracy.

[0035] For this purpose, the evaluation unit and / or the image acquisition unit can be calibrated accordingly, in particular in advance, preferably at the factory, and / or at regular intervals, preferably as part of maintenance work.

[0036] The evaluation unit can advantageously be configured to document the temperature and / or temperature limit exceedance of the thermochromic element and / or output this information to an operator, thereby significantly increasing operational safety and / or the reliability and / or tolerability of a medical and / or surgical procedure. Furthermore, the documentation of a procedure can be improved. In addition, therapeutic follow-up measures after a procedure can be provided in a more targeted manner.

[0037] Output to the operator, particularly a treating physician and / or surgeon, can be visual and / or, advantageously, also audible. For example, visual feedback could take the form of a color highlight on a display screen of the medical system, and especially on the medical instrument device. A flashing signal would also be conceivable. Audible feedback could take the form of a sound signal or a spoken warning, which could be delivered via a loudspeaker on the medical system, and especially on the medical instrument device. The loudspeaker could be integrated into the display screen.

[0038] In a further embodiment of the invention, the evaluation unit can be configured to output at least one control command for controlling an energy application unit and / or a liquid pump based on the temperature and / or temperature limit exceedance of the thermochromic element. This enables an automatic response to a temperature and / or temperature limit exceedance of the thermochromic element, which can particularly help to lower the temperature in the treatment area.

[0039] The control command is advantageously designed in such a way that it reduces the energy input into the treatment area and / or increases the fluid flow into the treatment area.

[0040] The medical instrument device may include the energy application unit, which is designed to introduce energy into the treatment area, in particular by means of ultrasound, laser radiation, radio frequency (RF) energy and / or electric, magnetic and / or electromagnetic fields.

[0041] Furthermore, the medical instrument device may include the liquid pump, which is designed to supply and / or remove and / or circulate at least one liquid, in particular aqueous and / or non-aqueous solutions, to the treatment area.

[0042] For example, the thermochromic element can include a label and / or marking on the instrument body, enabling a particularly advantageous design. In particular, the amount of thermochromic material can be advantageously minimized. Furthermore, since the label and / or marking is known, pattern recognition by the evaluation unit can be performed with exceptional reliability.

[0043] Particularly advantageous is the labeling of a brand name and / or the marking of a brand logo, which can draw the attention of a treating person to the brand name and / or brand logo, thus strengthening the brand itself and also bringing about an advertising effect.

[0044] The marker can also be designed as an add-on part for attachment to the instrument body. Alternatively, the marker can be part of such an add-on part of the medical instrument device. For example, the add-on part could be designed as a clip or a ring that can be arranged on the instrument body.

[0045] According to the invention, the thermochromic element is configured to undergo a spectral change in the non-visible, preferably infrared, multispectral and / or hyperspectral, wavelength range. This minimizes distraction for the person treating the patient, while still enabling automated detection of a temperature and / or a temperature limit exceedance.

[0046] The devices, units, and systems according to the invention are not intended to be limited to the application and embodiment described above. In particular, they may, to fulfill a function described herein, have a different number of individual elements, components, and units than specified herein. Furthermore, values ​​within the specified limits of the value ranges stated in this disclosure are also considered disclosed and freely usable.

[0047] The present invention is described below by way of example with reference to the accompanying figures. The drawing, the description, and the claims contain numerous features in combination. A person skilled in the art will expediently consider the features individually and use them meaningfully in combination within the scope of the claims.

[0048] If more than one copy of a particular object exists, only one of them may be identified with a reference symbol in the figures and description. The description of this copy can then be applied to the other copies of the object.

[0049] They show: Fig. 1 a medical system with a medical instrument device, Fig. 2 a part of a medical instrument of the medical system and Fig. 3 an alternative embodiment of a medical instrument.

[0050] Fig. Figure 1 schematically shows a medical system 30, which can be configured, for example, as a laparoscopy system, a urological endoscopy system, or an arthroscopic endoscopy system. The medical system 30 comprises a medical instrument device 10 for endoscopic use in aqueous and / or non-aqueous solutions within a treatment area 13 of a living organism. The medical system 30 also comprises a medical instrument 32, which is at least partially formed by the medical instrument device 10.

[0051] The medical instrument device 10 comprises an endoscope 38, which is inserted into the treatment area 13 through a natural or artificial body opening during a procedure. The medical instrument device 10 includes a lighting unit 36, which is connected to the endoscope 38 via a first light guide 40 of the medical instrument device 10. The lighting unit 36 ​​is configured to provide illumination for the treatment area 13. Within the endoscope 38, the illumination is guided to its tip in a known manner and shone into the treatment area 13.

[0052] The medical instrument device 10 has an image acquisition unit 16 for capturing at least one image of the treatment area 13. The image acquisition unit 16 is connected to the endoscope 38 by means of a second light guide 42 of the medical instrument device 10. The image of the treatment area 13 is guided in the endoscope 38 from its tip via the second light guide 42 to the image acquisition unit 16 in a known manner.

[0053] The image acquisition unit 16 is configured to record multi- or hyperspectral image data. For this purpose, it includes an image sensor unit (not shown) that operates according to the pushbroom principle. However, alternative or additional image acquisition methods would also be conceivable.

[0054] The medical instrument device 10 has an output unit 44 with a display, via which the image of the treatment area 13 can be displayed. During a procedure, the treatment area 13 can be viewed via the display.

[0055] The medical instrument device 10 has an energy application unit 20, which is configured to introduce energy into the treatment area 13. In this case, the energy application unit 20 is configured to introduce energy in the form of laser radiation into the treatment area 13. For this purpose, the energy application unit 20 has a laser, in particular a laser diode (not shown), the laser radiation of which can be introduced into the treatment area 13 of the medical instrument device 10 by means of a laser fiber 24. Alternatively or additionally, it would also be conceivable for the energy application unit 20 to be configured to introduce energy into the treatment area 13 by means of ultrasound and / or by means of electric, magnetic and / or electromagnetic fields.

[0056] The medical instrument device 10 comprises a liquid pump 22, which is configured to supply aqueous and / or non-aqueous solutions to and discharge them from the treatment area 13. The liquid pump 22 is designed as a circulation pump for circulating the aqueous and / or non-aqueous solutions. The medical instrument device 10 may include filters, separators, heat exchangers, and / or liquid reservoirs (not shown) in the liquid circuit.

[0057] The medical instrument device 10 has an instrument body 12 for insertion into the treatment area 13 and a thermochromic element 14 (see figure). Fig. 2), which is arranged on the instrument body 12. The thermochromic element 14 has a thermochromic transition temperature of less than 50°C.

[0058] The instrument body 12 and the thermochromic element 14 together form the aforementioned medical instrument 32.

[0059] In the present case, the instrument body 12 is designed as the laser fiber 24, the distal end region of which is in Fig. Figure 2 shows in more detail. The thermochromic element 14 is applied to the instrument body 12 in the form of a coating. The thermochromic element 14 is a thermochromic paint.

[0060] The thermochromic element 14 comprises a label 26 and a marking 28 on the instrument body 12. The label 26 can be a brand name. The marking 28 can be a brand logo. In alternative configurations, the thermochromic element 14 can also have only a label 26 or only a marking 28.

[0061] During a procedure, energy in the form of laser radiation is introduced into the treatment area 13 via the energy application unit 20, and in particular the laser fiber 24. Simultaneously, the liquid pump 22 operates and circulates the aqueous and / or non-aqueous solutions from the treatment area 13. The energy input can cause the aqueous and / or non-aqueous solutions to heat up, which may result in damage to surrounding tissue.

[0062] To prevent this, the image acquisition unit 16 is designed to take an image of the treatment area 13, which includes an image of the thermochromic element 14.

[0063] The medical instrument device 10 comprises an evaluation unit 18, which is configured to evaluate the image of the treatment area 13. The evaluation unit 18 is configured to identify the image of the thermochromic element 14 within the image of the treatment area 13. For this purpose, the evaluation unit 18 utilizes known pattern recognition methods. Since the shape of the thermochromic element 14 is known, the pattern recognition can be performed with very high reliability.

[0064] The evaluation unit 18 is configured to infer the temperature, or at least the temperature limit exceedance, of the thermochromic element 14 from its image. The evaluation unit 18 is further configured to document the temperature, or at least the temperature limit exceedance, of the thermochromic element 14 and output this information to an operator via the output unit 44, both as a visual signal on the display and as an audible signal via a loudspeaker on the output unit 44. Alternatively, only a visual or only an audible output would also be conceivable.

[0065] The evaluation unit 18 is configured to issue at least one control command for the energy application unit 20 and the liquid pump 22 based on the temperature, or at least the temperature limit exceedance, of the thermochromic element 14. It may be possible to reduce the radiant power of the energy application unit 20 and / or increase the flow rate of the liquid pump 22 when the temperature limit is exceeded. This provides an automated response to a temperature limit exceedance.

[0066] In one embodiment, the thermochromic element 14 can be configured to undergo a spectral change, in particular a color change, in the non-visible, specifically infrared, wavelength range. This color change is not visible to the operator on the display of the output unit 44, but can nevertheless be used for evaluation by the evaluation unit 18.

[0067] Fig. Figure 3 shows an alternative embodiment of a medical instrument 34. The medical instrument 34 comprises a medical instrument device 10 with an instrument body 12 for insertion into a treatment area 13 (see Figure 3). Fig. 1) and a thermochromic element 14, which is arranged in the instrument body 12.

[0068] In the present embodiment, the medical instrument 34 is designed as a clamp 46 with two clamping arms 48, 50. The clamping arms 48, 50 together form the instrument body 12.

[0069] The instrument body 12 is formed in one piece with the thermochromic element 14. The instrument body 12 is made of a thermochromic polymer. Accordingly, the clamping arms 48, 50 are also made of a thermochromic polymer. The instrument body 12, i.e., the clamping arms 48, 50, changes color when the thermochromic transition temperature of less than 50°C is exceeded. Reference symbol list 10 medical instrument devices 12 instrument bodies 13 Treatment area 14 thermochromic element 16 Image acquisition unit 18 evaluation units 20 Energy application unit 22 Liquid pump 24 laser fibers 26 Labeling 28 Marking 30 medical system 32 medical instruments 34 medical instruments 36 lighting units 38 Endoscope 40 first light guide 42 second light guide 44 output units 46 terminal 48 clamping legs 50 clamping legs

Claims

[1] Medical instrument device (10), in particular for use in endoscopic procedures in aqueous and / or non-aqueous solutions, comprising: - an instrument body (12) for insertion into a treatment area (13) and - a thermochromic element (14) which is arranged in and / or on the instrument body (12), wherein the thermochromic element (14) has a thermochromic transition temperature of less than 50°C, characterized by , that the thermochromic element (14) is configured to undergo a spectral change in the non-visible, preferably infrared, wavelength range. [2] Medical instrument device (10) according to claim 1, characterized by - an image acquisition unit (16) for capturing at least one image of the treatment area (13) which includes an image of the thermochromic element (14), wherein the image acquisition unit (16) is configured to capture multi- and / or hyperspectral image data. [3] Medical instrument device (10) according to claim 1, characterized by - an image acquisition unit (16) for capturing at least one image of the treatment area (13), which includes an image of the thermochromic element (14). [4] Medical instrument device (10) according to claim 2 or 3, characterized by - an evaluation unit (18) which is set up to evaluate the image of the treatment area (13). [5] Medical instrument device (10) according to claim 4, characterized by , that the evaluation unit (18) is configured to identify the image of the thermochromic element (14) in the image of the treatment area (13). [6] Medical instrument device (10) according to claim 4 or 5, characterized by , that the evaluation unit (18) is configured to infer from the image of the thermochromic element (14) a temperature and / or temperature limit exceedance of the thermochromic element (14). [7] Medical instrument device (10) according to claim 6, characterized by , that the evaluation unit (18) is configured to document and / or output to an operator the temperature and / or temperature limit exceedance of the thermochromic element (14). [8] Medical instrument device (10) according to claim 6 or 7, characterized by , that the evaluation unit (18) is configured to output at least one control command for controlling an energy application unit (20) and / or a liquid pump (22) based on the temperature and / or temperature limit exceedance of the thermochromic element (14). [9] Medical instrument device (10) according to claim 8, characterized by the energy application unit (20) which is designed to introduce energy into the treatment area (13), in particular by means of ultrasound, laser radiation, radio frequency (RF) energy and / or electric, magnetic and / or electromagnetic fields. [10] Medical instrument device (10) according to claim 8 or 9, characterized by the liquid pump (22) which is designed to supply at least one liquid, in particular aqueous and / or non-aqueous solutions, to the treatment area (13) and / or to discharge it from the treatment area (13). [11] Medical instrument device (10) according to any one of the preceding claims, characterized by , that the instrument body (12) is designed as a laser fiber (24). [12] Medical instrument device (10) according to any one of the preceding claims, characterized by , that the thermochromic element (14) includes a label (26) and / or marking (28) of the instrument body (12). [13] Medical system (30), in particular laparoscopy system, urological endoscopy system, gynecological endoscopy system or arthroscopic endoscopy system, comprising: - a medical instrument device (10) according to one of the preceding claims and - a medical instrument (32, 34) which is at least partially formed by the instrument device (10). [14] Medical instrument (32, 34), in particular a medical system (30) according to claim 13, comprising a medical instrument device (10) according to any one of claims 1 to 12.

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