A myocardial spectrometer probe and method of monitoring myocardium

Abstract

The present invention relates to a myocardial spectroscopy probe comprising: at least two separate light guides (120A, 120B) insertable into tissue, wherein a first light guide (120A, 120B) is configured to deliver light, a second light guide (120A, 120B) is configured to collect light, and the first light guide (120A, 120B) and the second light guide (120A, 120B) are arranged to be distinguished from each other.

Description

Technical Field

[0001] This invention generally relates to the field of medical technology. More specifically, this invention relates to a solution for monitoring the myocardium. Background Technology

[0002] Open-heart surgery involves opening the chest and establishing separate large veins or arteries for blood to flow into and out of the heart, or addressing obstructions in the heart itself, valves, arteries, shunts, muscle blockages, or other impaired cardiac function. In most cases, the heart's pumping action must be stopped to perform the surgery. When the heart stops, the coronary arteries supplying the myocardium must be blocked. This inevitably leads to myocardial ischemia. Currently, there is no way to measure the availability and metabolism of oxygen in the heart during aortic occlusion. Instead, experience and general knowledge from previous practice are used. In many cases, this is sufficient, but not always. Approximately 20% of hearts develop functional impairment postoperatively due to perioperative ischemia. This impairment is caused by myocardial stunning, a reversible decrease in cardiac contractility after reperfusion, rather than by tissue damage or reduced blood flow, or by myocardial infarction. However, it can also be due to irreversible myocardial damage caused by ischemia.

[0003] When performing coronary artery surgery on the heart, a designated procedure can be performed while the heart is beating, without the assistance of a cardiopulmonary bypass machine circuit. This designated procedure is called off-pump surgery. In this procedure, the heart is dislocated to properly establish the surgical area. Additionally, in these cases, myocardial ischemia occurs. Due to cardiac dislocation, electrocardiographic measurements cannot reliably detect myocardial ischemia until the heart is repositioned. Currently, there is no direct and reliable method to measure cardiac oxygenation to monitor myocardial ischemia during distal anastomosis suturing in off-pump surgery.

[0004] Almost all the oxygen in the heart is consumed in the mitochondria by an enzyme called cytochrome c-oxidase. This is the final enzyme in the electron transport chain that drives ATP production, the cell's ultimate fuel. Cells need carrier molecules to transport oxygen to cytochrome c-oxidase. In the blood, the carrier molecule is hemoglobin, which carries oxygen from distant locations to cells and eventually releases it into tissues when oxygen partial pressure is low. Inside the cell, myoglobin acts as a carrier to transport oxygen across the cell to the mitochondria.

[0005] Reliable real-time measurement of cardiac oxygen availability and / or metabolic status allows operating room personnel to perform various procedures during surgery to improve cardiac oxygen supply, reduce oxygen metabolism, and ultimately decrease the overall ischemic load on the heart. Measuring oxygen delivery by hemoglobin, myoglobin, and cytochrome c oxidase will open up possibilities for improving the safety of cardiac surgery, the treatment of general cardiac patients, and cost savings in treatment.

[0006] When assessing cardiac oxygenation status, it is clearly beneficial to simultaneously measure the reduced state and oxygen concentration of several other proteins with heme cofactors (such as hemoglobin, myoglobin, and other hemoglobins). Additionally, the ability to measure the concentrations of other molecules in the oxidative phosphorylation chain within mitochondria would be useful, including but not limited to: cytochromes A, B, and C may increase during myocardial metabolism analysis, where the reduced state of enzymes is important. In many cases, mitochondria exhibit very early damage when cellular stress occurs, and the concentrations of enzymes responding to mitochondrial stress are also of interest. Since mitochondria produce large amounts of reactive oxygen species (ROS), enzymes involved in catalyzing ROS are also of interest, such as catalase, superoxide dismutase, and peroxidase.

[0007] Measuring molecular concentrations in the myocardium is important both during and after surgery. During postoperative intensive care, patients experience multiple periods of lowest left ventricular function. For example, an oxidation measurement system is disclosed in document US2015 / 0282747A1, in which measurements are performed via a catheter device inserted into contact with the tissue wall of the subject. At least one drawback of this disclosed solution is that transcatheter measurements through the tissue wall are neither accurate nor specific.

[0008] Therefore, further solutions are needed, at least applicable to open-heart surgery, to accurately monitor molecular concentrations in the myocardium during open-heart surgery, and potentially continue monitoring after the surgery. However, monitoring cardiac molecular concentrations is beneficial throughout any treatment, where cardiac monitoring can provide additional insights for both the patient and the treatment staff. Summary of the Invention

[0009] The following is a simplified summary to provide a basic understanding of some aspects of various embodiments of the invention. This summary is not a broad overview of the invention. It is neither intended to identify key or essential elements of the invention nor to depict the scope of the invention. The following summary presents only some concepts of the invention in a simplified form as a prelude to a more detailed description of exemplary embodiments of the invention.

[0010] One object of the present invention is to provide a medical device for monitoring tissues.

[0011] Another object of the present invention is to provide a medical device that can be used, at least in part, to provide information about molecular concentrations and / or their oxygenation / oxidation ratios in tissues.

[0012] Another object of the present invention is to provide a method for monitoring an organization.

[0013] The object of the present invention is achieved by means of apparatus and methods as defined in the respective independent claims.

[0014] According to a first aspect, a myocardial spectrometer detector is provided, the myocardial spectrometer comprising: at least two separate light guides insertable into tissue, wherein a first light guide is configured to transmit light, and a second light guide is configured to collect light, and the first and second light guides are configured to be at least partially separated from each other.

[0015] The first and second light guides can be configured separately from each other, such that once they are inserted into the tissue of interest, at least a portion of the original tissue separates the first and second light guides.

[0016] By installing the first and second light guides in the fixture, the first and second light guides can be set up separately from each other.

[0017] The tip of the light guide can be at an angle of 45-90 degrees relative to the longitudinal axis of the light guide, preferably at an angle of 70-90 degrees.

[0018] The first and second optical guides can be implemented using one of the following methods: a single optical fiber, an optical fiber bundle, or an optical tube.

[0019] For example, at least a portion of at least one optical guide that can be inserted into tissue may be covered with a steel tube.

[0020] The myocardial spectrometer detector may also include a pacing lead, which is configured to travel along at least one of the optical guides. The pacing lead may be electrically connected to a steel tube covering at least a portion of at least one of the optical guides.

[0021] For example, a first pacing lead may be electrically connected to a steel tube of a first light guide, and a second pacing lead may be electrically connected to a steel tube of a second light guide, thereby forming a bipolar pacing setup including an anode and a cathode. Furthermore, the myocardial spectrometer detector may also include a stop device for adjusting at least one of the following: the insertion depth of at least one light guide in the tissue; and the insertion angle of at least one light guide in the tissue. The stop device may, for example, include a receiving portion for receiving at least the light guide and a photomask portion for at least partially preventing ambient light from entering the tissue. The receiving portion and the photomask portion of the stop device can be detachably mounted together. For example, a fixing wire is provided through the stop device, one end of which is fixed to the tissue, allowing the light guide to be tightened by utilizing the fixed position of the fixing wire. The fixing wire may be a pacing lead. The fixing device may be implemented by one of the following: an inflatable cuff device, a fixing mechanism for a second wire with an anchor forming an anchor for the fixing wire, or an anchoring device.

[0022] Additionally, the myocardial spectrometer detector may include an insertion aid for penetrating tissue to insert a light guide into the tissue. The insertion aid may include at least one tubular member within which the light guide is disposed. The light guide is configured to slide relative to the tubular member of the insertion aid. The insertion aid may also be configured to function as an electrode for coupling to a pacing lead connected to the insertion aid. The tissue-facing end of the tubular member of the insertion aid may be sharp. The insertion aid may be made of one of the following materials: stainless steel, ceramic, or composite material.

[0023] In addition, at least one of the photomask, the inflatable airbag device, the fixing mechanism, and the fixing line can be made of a biodegradable material.

[0024] The myocardial spectrometer detector may also include means for providing measurement data representing tissue temperature.

[0025] The myocardial spectrometer detector may also include a removably mounted protective cover for protecting the first and second light guides.

[0026] The protective shield can be configured to serve as a calibration target for calibrating measurement systems that utilize myocardial spectrometer detectors.

[0027] Myocardial spectrometer detectors can be used, for example, to monitor molecular concentrations in tissues in real time during and after open-heart surgery.

[0028] A method for monitoring the concentration of molecules in a tissue of interest using spectroscopy typically includes the following steps:

[0029] - Provide at least two separate light guides that can be inserted into tissue, wherein the first light guide is configured to transmit light and the second light guide is configured to collect light;

[0030] - Insert an optical guide into the tissue of interest such that at least a portion of the original tissue separates the first optical guide from the second optical guide, so that light transmitted by the first optical guide will pass through the original tissue to reach the second optical guide;

[0031] - Repeatedly transmitting light emitted from the first optical guide and collecting light emitted from the first optical guide through the second optical guide to form multiple signals corresponding to the collected light; and

[0032] - Monitor the signals obtained from this.

[0033] In this article, “quantity” refers to any positive integer starting from the first letter, such as one, two, or three.

[0034] In this article, the term "multiple" refers to any positive integer starting from two, such as two, three, or four.

[0035] Both in terms of structure and operation, various exemplary and non-limiting embodiments of the present invention, together with their additional objects and advantages, will be best understood from the following description of specific exemplary and non-limiting embodiments when read in conjunction with the accompanying drawings.

[0036] The verbs “comprising” and “including” are used herein as open-ended restrictions, neither excluding nor requiring the presence of any unrecorded features. Unless otherwise expressly stated, the features recited in the dependent claims may be freely combined with each other. Furthermore, it should be understood that the use of “a” or “an,” i.e., the singular form, in this document does not exclude a plurality. Attached Figure Description

[0037] Some embodiments are shown in the accompanying drawings by way of example rather than limitation.

[0038] Figure 1 The monitoring system to which this invention is applied is illustrated schematically.

[0039] Figure 2 A first example of a myocardial spectrometer detector according to an embodiment of the present invention is shown schematically.

[0040] Figure 3 A second example of a myocardial spectrometer detector in a first state is schematically shown according to an embodiment of the present invention.

[0041] Figure 4 A second example of a myocardial spectrometer detector in a second state is schematically shown according to an embodiment of the present invention.

[0042] Figure 5 A third example of a myocardial spectrometer detector according to an embodiment of the present invention is illustrated schematically.

[0043] Figure 6 A fourth example of a myocardial spectrometer detector according to another embodiment of the present invention is illustrated schematically.

[0044] Figure 7A and 7B Other embodiments according to the invention are illustrated schematically (in particular) Figure 6 A further example of a myocardial spectrometer detector (as shown in the embodiment).

[0045] Figure 8 Another example of a myocardial spectrometer detector according to an embodiment of the present invention is illustrated schematically. Detailed Implementation

[0046] The specific examples provided in the description below should not be construed as limiting the scope and / or applicability of the appended claims. Unless otherwise expressly stated, the list and combinations of examples provided in the description below are not exhaustive.

[0047] Now, through reference Figure 1 The embodiments are used to describe at least some aspects of the present technology. Figure 1 A monitoring system for monitoring a subject (i.e., tissue, such as the muscle of the heart 100) is schematically illustrated. The system operates at least in part based on spectroscopy, thereby determining the molecular concentrations and oxygenation / oxidation ratios in the monitored tissue. Additionally, as... Figure 1 The system illustrated is suitable for real-time monitoring of the tissue in question, which also allows for conclusions about the tissue's state of development, thus aiding in treatment planning.

[0048] The monitoring system may include a control unit 110 for controlling system operation. Additionally, the monitoring system may include at least two separate light guides 120A and 120B, which are separated from each other at their ends inserted into the monitored tissue.

[0049] The desired distinction formed between the measuring ends of light guides 120A and 120B can be achieved by passing light guides 120A and 120B through a clamp 130, which fixes the distance between light guides 120A and 120B. Between the clamp 130 and the control unit 110, light guides 120A and 120B can, for example, travel together within the same conductor 140 or be separated from each other. Depending on the operation of the monitoring system, the control unit 110 can be configured to generate light to the first light guide 120A to transmit light to the monitored tissue (e.g., myocardium), while the second light guide 120B can be configured to collect light from the monitored tissue (e.g., myocardium) and send it back to the control unit 110 for analysis based at least on the transmitted and collected light. Furthermore, the system may include additional elements and functionalities, such as means for providing cardiac pacing.

[0050] If the ability to provide cardiac pacing is integrated into the monitoring system, the control unit 110 can be functional in such a way that the pacing lead can be incorporated into or at least arranged along the same leads 140 as the optical leads 120A and 120B, and the clamp 130 can also be used to at least partially introduce the pacing lead into the myocardium. Furthermore, the monitoring system, particularly the spectrometer detector, can include one or more means and / or devices for attaching the measuring end of the detector to the monitored tissue, and one or more means and / or devices for improving the positioning of the optical leads 120A and 120B in the monitored tissue and for improving the signal-to-noise ratio in the measurement.

[0051] In the following description, various aspects of the present technology will be discussed by way of non-limiting embodiments.

[0052] Figure 2 This is a cross-sectional view, schematically illustrating an example of the measuring end of a myocardial spectrometer detector according to an embodiment of the present invention. A first optical guide 120A and a second optical guide 120B are arranged separately from each other via a clamp 130. The clamp 130 is configured such that the positions of the first optical guide 120A and the second optical guide 120B within the clamp 130 define a distance d between the first optical guide 120A and the second optical guide 120B at the measuring end (i.e., the portion inserted into the monitored tissue). m .

[0053] In one embodiment, the mutual distance d mAdvantageously, when the myocardial spectrometer detector is positioned in the tissue being monitored, the second light guide 120B is able to collect sufficient light to ensure a adequate signal level for performing monitoring, and at least a portion of the original tissue enters between the first and second light guides. In this embodiment, light enters the second light guide 120B from the first light guide 120A by no other means than through the tissue between light guides 120A and 120B.

[0054] In one embodiment, most of the light emitted from the first light guide and received by the second light guide will pass through the original tissue, while less than 10% (particularly less than 5%, preferably less than 1%) of the light received by the second light guide will pass through any surface tissue.

[0055] In one embodiment, the mutual distance between the first light guide 120A and the second light guide 120B is between 0.1 mm and 5 mm, preferably between 1 mm and 2 mm. Furthermore, in this application field, the insertion depth d of at least one of the light guides 120A and 120B is advantageously considered. t In the case of a myocardial spectrometer detector, the applicable insertion depth d t The depth can be approximately 3mm-10mm, preferably between 4mm and 6mm. This ensures that the optical guides 120A and 120B can pass through the surface layer to reach the myocardium, such as the epicardium, endocardium, epicardial fat, fibrous tissue, scar tissue, etc., thereby measuring the molecular concentration in the tissue. In one embodiment, at least one of the optical guides 120A and 120B is at the insertion depth.

[0056] In one embodiment, the myocardial spectrometer detector includes at least two separate light guides 120A, 120B that are insertable into tissue so that they can reach the myocardium through the surface of the tissue. The first light guides 120A, 120B are configured to transmit light, and the second light guides 120A, 120B are configured to collect light. The first light guides 120A, 120B and the second light guides 120A, 120B are configured to be at least partially separated from each other.

[0057] In one embodiment, the myocardial spectrometer detector includes at least two separate light guides 120A and 120B that can be inserted into tissue to an insertion depth of at least 3 mm (typically 3 to 10 mm), wherein the first light guides 120A and 120B are configured to transmit light and the second light guides 120A and 120B are configured to collect light, and the first light guides 120A and 120B and the second light guides 120A and 120B are configured to be at least partially separated from each other.

[0058] In some embodiments, light guides 120A and 120B may be coated in a suitable manner. For example, the coating may be configured such that in the portion of the light guides 120A and 120B that enter the tissue, the coating is provided with a steel tube that provides protection and support for the light guides 120A and 120B.

[0059] Additionally, portions of the light guides 120A and 120B extending from the clamp 130 toward the control unit 110 may be coated with a suitable plastic material, such as an acrylic coating. Advantageously, the boundaries between the different coating materials are arranged inside the clamp 130 to hold the coatings in place and provide structural support at the joint location. The clamp described herein, which provides support to hold the light guides at a predetermined distance relative to each other, can be made of any material or form capable of providing this function. The clamp may be permanently fixed to the light guides or may be removable. Furthermore, the coatings of the light guides 120A and 120B, particularly the coating on the side entering the monitored tissue, may be selected to make the light guides 120A and 120B rigid to support the surface of the tissue in question and puncture of other layers.

[0060] In some embodiments, the light guides 120A and 120B may be made of biodegradable materials.

[0061] In some embodiments, the light guide may be inserted into one or more holes in a solid material block that protects the light guide during or after manufacturing. If the material block has suitable and known optical properties, it can also be used for calibrating the predictive quantity of the detector.

[0062] Additionally, as from Figure 2 It can be deduced that the tips of light guides 120A and 120B can be designed to optimize the way light is transmitted between light guides 120A and 120B. The design of the tips can be achieved by considering the applicable angle α formed in the tips of light guides 120A and 120B relative to their longitudinal axis. According to the invention, an advantageous angle α is 45°-90°, preferably 70°-90°. Furthermore, in at least some embodiments, the tips of the first light guide 120A and the second light guide 120B can be configured such that the openings (i.e., angled surfaces) of the light guides having angle α face each other, as in... Figure 2 The diagram is schematically shown. Angle α can be produced in light guides 120A and 120B, for example, by cutting, grinding, or polishing the light guides. Any material or lens capable of producing light convergence, divergence, or diffusion can be used in front of one or more light guide heads.

[0063] The first optical guide 120A and the second optical guide 120B may comprise one or more optical fibers (i.e., a single optical fiber or a bundle of optical fibers), or be implemented using optical tubes. The physical implementation of the optical guides can be considered from the perspectives applicable in this application field, independent of the physical implementation of the optical guides, as discussed in the preceding description.

[0064] The thickness of the light guides 120A and 120B, i.e. the physical entities selected to realize the function of the light guides 120A and 120B, is preferably between 100μm and 400μm.

[0065] Figure 3 Some further aspects of the invention are illustrated schematically. Specifically, the tip of at least one of the optical guides 120A and 120B as described above should be introduced into the tissue whose properties will be measured. For example, regarding access to the myocardium, the optical guides 120A and 120B should puncture multiple inherently dense layers before attachment to the myocardium. To facilitate the puncture of the optical guides 120A and 120B into one or more of the aforementioned layers, an insertion aid 310 may be provided in the detector. The insertion aid 310 is a means of protecting the optical guides 120A and 120B during insertion of the detector into the measurement position, and also has a structure and shape capable of penetrating layers and even helping to maintain a designed mutual distance between the optical guides 120A and 120B. According to an exemplary embodiment, the insertion aid 310 includes tubular members 320A and 320B into which the optical guides can be inserted. The tubular members 320A and 320B are preferably sharp at the tissue-facing ends to cut the tissue for puncture. At the other end, tubular members 320A and 320B are mounted on a support plane 330, which in one state, for example, faces the clamp 310. Figure 3 As can be deduced, the dimensions of the insertion auxiliary device 310, particularly the lengths of the tubular members 320A and 320B, can be advantageously adjusted so as not to interfere with the transmission of light between the light guides 120A and 120B. In one embodiment, when the light guides 120A and 120B are inserted to a predetermined depth, they also extend from the insertion auxiliary tube, so that the tube does not interfere with the transmission of light between the light guides 120A and 120B.

[0066] According to some embodiments, the insertion assistance device 310 may be configured to be at least partially movable relative to the light guides 120A, 120B. Therefore, it can be considered that... Figure 3 The state shown corresponds to the insertion of the myocardial spectrometer detector into the tissue, i.e., the insertion phase. On the other hand, in Figure 4 The diagram schematically discloses an example of a detector with an insertion aid 310, in a state where the detector has entered the tissue and the light guides 120A and 120B extend from the tubular members 320A and 320B. In other words, as Figure 4The illustrated state is established when the detector is located at the measurement position within the tissue. Therefore, the insertion aid 310 can be slidably arranged relative to the light guides 120A, 120B, for example, such that in response to the tissue facing the support plane 330, the insertion aid 310 begins to slide along the light guides 120A, 120B, for example, until the support plane 330 reaches the clamp 130. Naturally, in this state, the light guides 120A, 120B slide out from the tubular members 320A, 320B for measurement.

[0067] The sliding mechanism described above can be achieved by adjusting the inner diameter of the tubular members 320A and 320B to match the outer diameter of the corresponding light guides 120A and 120B, such that the total friction between the entities exceeds the force required for the detector to puncture the tissue. The friction can also be adjusted by modifying the surfaces of the aforementioned entities (e.g., by optimally roughening these surfaces). The suitable material for the insertion aid 310 can be, for example, stainless steel (e.g., a hypodermic needle). Furthermore, as mentioned above, the tissue-facing ends of the tubular members 320A and 320B can be sharp, or at least their profiles are preferably designed to ensure easy and safe insertion into the tissue.

[0068] Figure 5 Another aspect of the invention is schematically illustrated according to another embodiment. In this embodiment, a stop device 510 is introduced in the myocardial spectrometer detector. The stop device 510 provides a method for adjusting the depth of insertion of the light guides 120A, 120B into the tissue as needed within the application area. Additionally, the stop device can be used to adjust the insertion angle, which is achieved by configuring the light guides 120A, 120B to exit the stop device 510 at a desired angle toward the tissue. Thus, compared to, for example, in... Figure 2 Compared to a detector schematically shown without a stop device 510, the stop device 510 helps to adjust the position of the detector in the tissue. The stop device 510 may, for example, consist of a receiving portion 520 and a photomask portion 530. The receiving portion 520 may, for example, include an adapter for receiving a clamp 130 for holding the light guides 120A, 120B, wherein by designing the adapter at a desired angle, the angle at which the light guides 120A, 120B enter the tissue can be at least partially defined.

[0069] In other words, in one embodiment, a channel is provided in the stop device 510 to provide a path for the light guides 120A and 120B to pass through the stop device 510. Additionally, the photomask portion 530 acts as a stop against the tissue, but also prevents ambient light from entering the tips of the light guides 120A and 120B, especially those configured to collect light. This can be important, particularly since the myocardial spectrometer detector can be used during cardiac surgery requiring good illumination. This provides a large amount of ambient light, thereby reducing the signal-to-noise ratio of optical measurements. Therefore, the photomask portion 530 can be important for reducing noise during measurements.

[0070] For example, the area of ​​the photomask can be 0.1 cm². 2 up to 5cm 2 Preferably, it is 0.5cm. 2 -2cm 2 For example, the photomask portion and the entire stop device 510 can be made of a biodegradable material, polymer, metal, or glass. Additionally, the photomask portion 530 can be shaped to allow it to adhere well to the monitored tissue, or it may include one or more openings for suturing the photomask portion 530 to the tissue. Furthermore, the photomask portion 530 can be shaped to facilitate removal, for example, by including anchors for gripping, before closing the thoracic cavity after open-heart surgery, and at the start of the postoperative phase. Further, in some embodiments, the stop device 510 can provide a reaction force to the fixation device used to anchor the detector at its measuring position, which will be discussed in the following description. The stop device 510 can be used in conjunction with the insertion aid 310, similar to... Figure 3 and Figure 4 The content described in the description.

[0071] Figure 6 Another example embodiment is illustrated schematically. Figure 6 In the middle, the myocardial spectrometer detector is connected to an organ that is in Figure 6 The image shown depicts the heart. Figure 6 In one embodiment, the fixation wire 610 is brought to the myocardium along the light guides 120A, 120B. The fixation wire 610 may be coupled to the clamp 130, and in embodiments where the stop device 510 is applied, the fixation wire 610 may be arranged in the same channel as the light guides 120A, 120B that travel through the stop device 510. The fixation wire 610 may be secured and positioned to a needle tip, for example, by using a needle in open-heart surgery, enabling it to puncture tissue and be positioned to travel a predetermined distance within the tissue, and at a certain location (in... Figure 6 (Indicated by the letter "A") leaves the tissue. After the fixation suture 610 is positioned in the tissue, the needle can be removed by cutting the suture at the applicable location.

[0072] Advantageously, one end of the fixation wire 610 is fixed in the withdrawn position, preferably removably. In this arrangement, the fixation wire 610 can be used to anchor the myocardial spectrometer detector in the monitored tissue. After the other end is fixed in the tissue at the withdrawn position A, anchoring can be achieved by pulling the fixation wire 610 taut from the end of the stop device 510. As a result, the detector itself is firmly attached to the tissue, and the light guides 120A, 120B remain stationary in the measurement position, and at least partially eliminates artifacts caused by motion. The anchoring of the fixation wire can also be achieved using metal or biodegradable surgical clips.

[0073] In some embodiments, a pacing lead can be used as the fixation wire 610. The pacing lead allows for pacing of the myocardium whenever needed, such as during and after surgery.

[0074] Figure 7A and 7B Some non-limiting examples of applicable solutions for securing a fixation wire 610, such as a pacing lead, to the tissue in question are illustrated schematically. For clarity, it is assumed here that the fixation wire 610 is a pacing lead. Figure 7A In one embodiment, a fixed example is shown, wherein the pacing lead is positioned in the myocardium (see [reference]). Figure 6 The inflatable cuff assembly 710 is inserted into the end of the pacing lead as it exits the tissue. The inflatable cuff assembly 710 is a ring-shaped device that secures the pacing lead in the exit position and thus allows for [further action] as directed. Figure 6 As described, tension is applied between the end of the pacing lead and the detector itself. The inflatable balloon device 710 can be attached to the end of the pacing lead when deflated and then inflated using a suitable inflation device. This can be done, for example, during open-heart surgery. One advantage of the inflatable balloon device 710 is that, after open-heart surgery, when the detector and pacing lead remain in the body, after the balloon is remotely deflated, both the detector and pacing lead can be remotely (i.e., percutaneously) removed from the outside by pulling the detector outward. Deflating the balloon device 710 allows the pacing lead to be pulled back through the myocardium.

[0075] Similar to those that utilize inflatable airbag devices, such as Figure 7A The schematically illustrated fixation solution can be achieved by an anchoring device made of a material with sufficient friction to the tissue surface, wherein the anchoring device is positioned on the surface of the tissue. The fixation suture is now removed from the tissue in the same manner as an inflatable balloon device, but it is attached to the anchoring device in a specific way.

[0076] For example, the anchoring device may include a hole or slot through which the anchoring wire passes. The relative dimensions of the hole or slot and the diameter of the anchoring wire can be advantageously chosen such that their mutual friction is sufficient to tighten the detector by pulling the anchoring wire outward from the tissue at the detector tip. However, in a preferred solution, the friction between the entities is configured such that as a pull exceeding a selected level occurs, the anchoring wire begins to slide through the hole or slot, and in this way, the anchoring wire can be removed from the tissue. For example, the anchoring device may be made of plastic or any other material suitable for operation in the described manner. Clamps may also be used. In some embodiments, the anchoring device may be made of a biodegradable material capable of retaining the anchoring device within the body.

[0077] Figure 7B Another example of securing a pacing lead in the heart according to another embodiment of the invention is schematically depicted. Here, the pacing lead is configured to travel over the myocardium, i.e., it does not pass through the photomask portion 530, but is configured to travel over it. Furthermore, the wire 720 is configured to travel within the tissue, and a fixation mechanism 730, such as a loop, is provided at the location where the wire 720 exits the tissue. This is achieved by guiding the pacing lead (see...) Figure 7B The 610 (of which) passes through the loop and is pulled taut from the detector end, and the pacing lead can be secured to the tissue accordingly through anchoring. This fixation can be configured to be performed during open-heart surgery. According to Figure 7B The example fixation also allows for remote removal by loosening wire 720 and pulling out the pacing lead. The wire can then be removed as well. In some embodiments of the invention, the pacing lead fixation can utilize... Figure 7B The fixing mechanism is implemented by having holes arranged in the photomask portion 530, through which the wire and loop are arranged on the surface of the photomask portion 530. By guiding the pacing lead through the loop, tension can be formed on the surface of the photomask portion 530 to reduce damage to the tissue in question due to tension. In some other embodiments, a sieve plate, for example made of a biodegradable material, is provided below the pacing lead at the location where the wire 720 leaves the tissue to avoid [damage / damage]. Figure 7B Damage to the tissue as described in the embodiments.

[0078] In addition, Figure 7B The mechanism illustrated in the diagram can also be configured in reverse, so that... Figure 7B The 720 line is implemented together with a pacing lead, wherein the pacing lead has a loop at the end of the line, and the line is configured to be similar to Figure 7B The pacing lead travels through the heart muscle. Now, by inserting a line that travels through the heart muscle and passing it through a loop located at the end of the pacing lead, fixation can be provided by pulling on the pacing lead that is traveling within the heart muscle.

[0079] To enhance the removal of the pacing leads and the removal of the photoconductors 120A and 120B from the body, they can be enclosed individually or in some combination within a plastic or silicone tube. The diameter of the tube can be adapted to the diameter of the clamp 120 holding the photoconductors 120A and 120B, thereby enabling smooth removal of the removable portion of the detector. The pacing leads themselves can be made of biocompatible materials, such as stainless steel. For example, the length of the pacing leads can range from 0.1m to 10m, depending on the requirements.

[0080] Furthermore, in some embodiments, the photomask portion 530 may be configured to serve as an anode or cathode of a bipolar pacing setup, depending on the function of the pacing lead tip (i.e., in the function of another electrode). In such embodiments, at least a portion of the photomask portion 530 is made of a conductive material connected to the other pacing lead. Accordingly, in some other embodiments, the insertion aid 310 may be used as an electrode for the pacing setup. Depending on the implementation, for example, one of the tubular members 320A, 320B may be connected to one of the pacing leads and advantageously insulated from other portions of the insertion aid 310 so as to establish an electrode through another electrode established at the tip of the pacing lead. Furthermore, in the case where the photoconductors 120A, 120B are covered with steel tubing, the pacing lead may be connected to at least one steel tubing, and the electrode may be established in this manner.

[0081] Regarding the removal of the myocardial spectrometer detector, further explanation can be given concerning the photomask portion 530. In some embodiments, at least in part due to its shape, the photomask portion 530 may remain on the heart after the detector is removed. In this embodiment, the photomask portion 530 and the receiving portion 520 of the detector are detachably coupled to each other. The coupling can be configured such that decoupling requires less power than removing the photomask portion 530 from the tissue to which it is mounted. Thus, as a result of pulling the detector outward, the receiving portion 520 and the photomask portion 530 separate from each other, thereby leaving the photomask portion 530 on the surface of the tissue in question. In this embodiment, the photomask portion 530 is advantageously made of a biodegradable material, such as a suitable polymer.

[0082] In another embodiment, the photomask portion 530 may be at least partially made of a foldable material. Now, when the detector is to be removed from the tissue and pulled out of the body, the foldable photomask portion 530 is configured such that the photomask portion 530 enters and passes through the aperture in a folded shape, through which the detector is removed from the body.

[0083] Furthermore, in some embodiments, the photomask portion 530 of the detector can be attached to the tissue by suturing it with multiple sutures. In such embodiments, the photomask portion 530 may include one or more holes for attachment, such as using sutures. Advantageously, the sutures release the photomask portion 530 from the tissue in response to a tension exceeding a preset value. The sutures may be made of biodegradable materials, or even stainless steel or other biocompatible materials. In some embodiments, sutures made of conductive materials can be used as electrodes for cardiac pacing, wherein pacing leads are coupled to such sutures.

[0084] Figure 8 Another exemplary embodiment of the detector according to the invention is schematically illustrated. This exemplary embodiment is based on an implementation in which at least some portions of the inserted auxiliary device are integrated with the clamp 130. In this embodiment, the tubular members are configured as conductive tubes 810A, 810B, such as metal tubes, which are fixed in the clamp 130 in an adaptable manner, for example by gluing them to the clamp 130. The conductive tubes 810A, 810B, as tubular members, provide a path for the corresponding light guides 120A, 120B to enter the tissue being monitored. In other words, the conductive tubes 810A, 810B provide channels through the clamp 130 to properly position the light guides 120A, 120B for monitoring. Figure 8 The conductive tubes 810A and 810B of the disclosed embodiments can be implemented using a suitable coating of the photoconductors 120A and 120B as described above. According to an exemplary embodiment, each conductive tube 810A and 810B is configured with a corresponding pacing lead 820A and 820B to establish an anode and cathode, thereby providing bipolar pacing to the myocardium when needed. Therefore, the pacing leads 820A and 820B and the corresponding conductive tubes 810A and 810B are electrically contacted to conduct electricity at the contact points. The contact points may be configured to be located inside the clamp 130, and, for example, suitable connectors may be configured to form contacts into which the pacing leads 820A and 820B can be inserted. Alternatively or additionally, contact may be achieved by soldering, tinning, or pressure. Furthermore, the clamp 130 is made of a non-conductive material. A light shield may also be used with... Figure 8 The example embodiments shown are used together. By arranging pacing leads 820A, 820B to the corresponding tubular members 320A, 320B, Figure 8 The basic idea can also be applied to individual insertion aids (e.g., see example). Figure 3 and Figure 4 In the case of the embodiment), the tubular members 320A and 320B are separated from each other by a non-conductive material (for example, see the material of the support plane 330).

[0085] Additionally, in some exemplary embodiments, the myocardial spectrometer detector further includes a removably mounted protective cover to protect the first and second light guides 120A, 120B, for example, during periods when the detector is not in use (such as during storage and transport of the detector). In some other embodiments, the protective cover is configured to operate for calibrating calibration targets of measurement systems using the myocardial spectrometer detector. To enable calibration, the characteristics of the protective cover should be selected accordingly. In one example embodiment, the material of the protective cover may be selected such that the absorption coefficient for light used in the 600-900 nm wavelength range for measurement should be constant and reasonably low, for example, below 0.001 mm. -1 .

[0086] In another embodiment, the scattering coefficient of the material corresponds to the reduced scattering coefficient of the monitored tissue, for example, ~1 mm. -1 Furthermore, the size and shape of the protective cover are preferably configured such that the boundary areas of the material and the cavity into which the light guide is inserted do not interfere with calibration due to background light. For example, the shape may be such that it extends at least 3 mm in each direction from the tips of the light guides 120A and 120B. Suitable materials may be, for example, transparent epoxy resin and titanium dioxide or optical polytetrafluoroethylene.

[0087] Even though the foregoing description addresses the scenario where the first light guide 120A and the second light guide 120B reach the same depth within the tissue, the present invention is not limited to this embodiment. That is, the insertion depth between light guides 120A and 120B can vary, as long as the collected light enables meaningful measurements of the monitored parameters. In some embodiments of the invention, one light guide 120A or 120B may be positioned on the surface of the tissue, or its insertion depth may be such that it only penetrates the epicardium, while the other light guide 120A or 120B is inserted deeper into the tissue surface.

[0088] Generally, myocardial spectrometer detectors can be used to monitor molecular concentrations in tissues in real time, for example, during and after open-heart surgery. The applied spectra can be, for example, so-called diffuse spectroscopy, diffuse reflectance spectroscopy, Raman spectroscopy, Fourier transform spectroscopy, or fluorescence spectroscopy.

[0089] Therefore, a method for monitoring molecular concentrations in a tissue of interest via spectroscopy includes providing at least two separate light guides, wherein a first light guide is configured to transmit light and a second light guide is configured to collect light. The light guides are inserted into the tissue of interest, particularly myocardium, such that at least a portion of the original tissue separates the first light guide from the second light guide. Thus, light transmitted by the first light guide will pass through the original tissue to reach the second light guide.

[0090] In this method, light from a first optical guide is transmitted (or emitted), and the light transmitted from the first optical guide is received by a second optical guide. Multiple light pulses are transmitted and received to form multiple signals corresponding to the collected light. The signals thus obtained are used to monitor tissue of interest. Typically, 1 to 100 pulses are transmitted and received per second, particularly 2 to 50 pulses, such as 5 to 20 pulses or 8 to 15 pulses.

[0091] In one embodiment, in Figure 1 The measurement system disclosed in the context of any of the embodiments described herein generates clinically relevant information about cardiac metabolism, simultaneously measured from intracellular, cytosol, extracellular, and intravascular molecular concentrations. In another embodiment, the system can measure the molecular concentration of oxidative phosphorylation chains within mitochondria during cardiac surgery.

[0092] In one embodiment, a myocardial spectrometer detector is used to monitor changes in enzyme concentration in response to mitochondrial stress.

[0093] In one embodiment, a myocardial spectrometer detector is used to monitor the molecular concentrations of catalase, superoxide dismutase, and peroxidase, and combinations thereof.

[0094] In addition, the myocardial spectrometer detector can be connected to an online monitor, for example, via a control unit, to display relevant information about myocardial metabolism to medical personnel in real time, enabling them to respond accordingly on-site.

[0095] As can be deduced from the foregoing description, at least some essential features of the present invention are light guides 120A and 120B, wherein at least one first light guide introduces light and at least one second light guide collects light, which are disposed separately from each other at a measurement location in the tissue being monitored (e.g., myocardium) to establish a reliable measurement setup, wherein at least a portion of the emitted light is transmitted through the tissue between the light guides 120A and 120B. The distance between the light emitting light guides 120A and 120B and the light collecting light guides 120A and 120B is predetermined.

[0096] Depending on the type of measurement, i.e. whether it is performed using a beating or a stationary heart, it may be necessary to fix the optical guides 120A and 120B to the tissue.

[0097] This invention also allows for the use of temporary pacing wires to support patients postoperatively during open-heart surgery. Different positioning of the light guide also provides the possibility of combining temporary cardiac pacing wires in the same construction in the aforementioned manner, for example, by covering the light guide with metal or any other conductive material. Furthermore, the described construction enables the implementation of further measurements from the tissue, such as temperature measurements of the tissue using electronic or optical means. In other words, an applicable sensor can be positioned in the portion of the detector from which measurement data can be obtained (e.g., the light guide or insertion aid). Alternatively or additionally, the temperature can be determined from the measurement data obtained using the light guide, i.e., optically.

[0098] The specific examples provided in the description above should not be construed as limiting the applicability and / or description of the appended claims. Unless otherwise expressly stated, the list and combinations of examples provided in the above description are not exhaustive.

Claims

1. A myocardial spectrometer detector, comprising: At least two separate light guides that can be inserted into tissue, wherein a first light guide is configured to transmit light, a second light guide is configured to collect light, and the first and second light guides are configured to be at least partially separated from each other. The tip of the light guide forms a 70-90 degree angle with respect to the longitudinal axis of the light guide. The light guide is coated to make it rigid to support punctures into the tissue surface and other layers. By mounting the first and second light guides in the fixture (130) in a manner that separates the first and second light guides from each other, at least a portion of the original tissue separates the first light guide from the second light guide once they are inserted into the tissue.

2. The myocardial spectrometer detector according to claim 1, characterized in that, The first and second optical guides can reach the myocardium through the surface of the tissue.

3. The myocardial spectrometer detector according to claim 1, characterized in that, The first optical guide and the second optical guide are implemented using one of the following methods: a single optical fiber, an optical fiber bundle, or an optical tube.

4. The myocardial spectrometer detector according to claim 1, characterized in that, At least a portion of at least one of the optical guides that can be inserted into the tissue is covered with a steel tube.

5. The myocardial spectrometer detector according to claim 4, characterized in that, The myocardial spectrometer detector also includes a pacing lead configured to travel along at least one of the light guides.

6. The myocardial spectrometer detector according to claim 5, characterized in that, The pacing lead is electrically connected to the steel tube covering at least a portion of at least one of the optical guides.

7. The myocardial spectrometer detector according to claim 6, characterized in that, The first pacing lead is electrically connected to the steel tube of the first optical guide, and the second pacing lead is electrically connected to the steel tube of the second optical guide to form a bipolar pacing setup including an anode and a cathode.

8. The myocardial spectrometer detector according to claim 1, characterized in that, The myocardial spectrometer detector further includes a stop device (510) for adjusting at least one of the following: the insertion depth of at least one of the light guides in the tissue; and the insertion angle of at least one of the light guides in the tissue.

9. The myocardial spectrometer detector according to claim 8, characterized in that, The stop device (510) includes a receiving portion (520) for receiving at least the light guide and a photomask portion (530) for at least partially preventing ambient light from entering the tissue.

10. The myocardial spectrometer detector according to claim 9, characterized in that, The receiving portion (520) and the photomask portion (530) of the stop device (510) are detachably mounted together.

11. The myocardial spectrometer detector according to claim 9, characterized in that, A fixing line (610) is provided passing through the stop device (510), one end of the fixing line (610) being fixed to the tissue, so that the light guide can be tightened by using the fixed position of the fixing line (610).

12. The myocardial spectrometer detector according to claim 11, characterized in that, The fixed line (610) is a pacing lead.

13. The myocardial spectrometer detector according to claim 11, characterized in that, The fixing is achieved by one of the following: an inflatable airbag device (710), a fixing mechanism (720) provided with a second line (739) forming an anchor for fixing line (610), and an anchoring device.

14. The myocardial spectrometer detector according to claim 1, characterized in that, The myocardial spectrometer detector further includes an insertion aid (310) for penetrating the surface of the tissue to insert the light guide into the tissue, wherein the insertion aid (310) includes at least one tubular member, and the light guide is disposed within the tubular member.

15. The myocardial spectrometer detector according to claim 14, characterized in that, The light guide is configured to slide relative to the tubular member of the insertion aid (310).

16. The myocardial spectrometer detector according to claim 14, characterized in that, The insertion aid (310) is configured as an electrode for use as a pacing lead coupled to the insertion aid (310).

17. The myocardial spectrometer detector according to claim 14, characterized in that, The tubular member of the insertion aid (310) has a pointed end facing the tissue, and the insertion aid (310) is made of one of the following materials: stainless steel, ceramic or composite material; or a combination thereof.

18. The myocardial spectrometer detector according to claim 13, characterized in that, At least one of the photomask portion (530), the inflatable airbag device (710), the fixing mechanism (720), and the fixing line (610) is made of a biodegradable material.

19. The myocardial spectrometer detector according to claim 1, characterized in that, The myocardial spectrometer detector also includes means for providing measurement data representing tissue temperature.

20. The myocardial spectrometer detector according to claim 1, characterized in that, The myocardial spectrometer detector also includes a detachably mounted protective cover for protecting the first and second light guides, the protective cover being configured to serve as a calibration target for calibrating a measurement system incorporating the myocardial spectrometer detector.

21. The myocardial spectrometer detector according to claim 1, characterized in that, The first and second optical guides can be inserted into the myocardial tissue between the epicardium and endocardium, so that the light transmitted by the first optical guide will pass through the original tissue in the myocardium and reach the second optical guide.

22. The myocardial spectrometer detector according to claim 1, characterized in that, The myocardial spectrometer detector is used to monitor molecular concentrations in tissues in real time during and after open-heart surgery.

23. The myocardial spectrometer detector according to claim 22, characterized in that, The myocardial spectrometer detector is used to monitor the molecular concentration in tissues in real time, wherein the monitoring includes the application of diffuse spectroscopy, Raman spectroscopy, Fourier transform spectroscopy, or fluorescence spectroscopy.

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