Patent Application
20180280071
This application claims the benefit of German Patent Application No. 10 2017 106 747.7 filed Mar. 29, 2017, the contents of which is incorporated herein by reference as if fully rewritten herein.
The invention relates to a generator for supplying a tissue fusion instrument, in particular an instrument for vessel fusion. At the same time, the invention relates to a method for the control of a generator for supplying such an instrument.
The surgical application of coagulation instruments, in particular tissue fusion instruments, on the patient occurs under considerable pressure of time in most cases. If many coagulation measures are to be performed during a surgical intervention, in particular the closure of many vessels and, optionally, the severing of said vessels, it is important that the vessels be closed within the least possible time. The minimum possible damage and coagulation of the surrounding tissue is to occur in order to minimize undesirable lesions. On the other hand, the closure must be secure so that closed and subsequently severed vessels will not open during or after surgery and thus result in bleeding.
Typically, vessel fusion takes place between two branches of a fusion instrument to which a high-frequency coagulation is applied and which compress a vessel grasped between them and which heats it by current flow-through.
Such an instrument and associate coagulation processes can be inferred from publication U.S. Pat. No. 8,216,223 B2. The instrument is associated with a system that generates a test pulse to the instrument at the start of a coagulation process in order to detect the tissue impedance. Additionally or alternatively, the system may determine characteristics of the electrosurgical instrument at the start of the treatment. Then, the system determines whether a reaction of the tissue is to be recorded and determines a desired impedance trajectory based thereon. Considering this, the system determines the impedance of its target value based on a desired rate of change. Then the system monitors the maintenance of this desired impedance trajectory, in which case it detects the temperature, the tissue type or the like. In addition, the system is able to detect the quantity of energy delivered to the tissue during the sealing process and to stop the continued delivery of energy for a specified period of time when the impedance exceeds a threshold above the value of the initial impedance. When the application of energy to the tissue is completed, the system may provide a cooling period. The cooling period acts to solidify the collagen in the sealed tissue, in which case the cooling time is a fixed period of time or an adaptive period of time that is a function of values that are related to the tissue fusion process. Upon expiration of the cooling period, the sealing process is completed. The system may comprise active cooling elements to accelerate cooling such as, for example, heat pipes or Peltier elements.
Publication U.S. Pat. No. 5,827,271 also illustrates a tissue fusion instrument, in which the vessels are compressed between two energized branches and through which current flows and which can thus be heated in order to fuse the tissue or the vessel. After fusion has taken place, the power output to the instrument is lowered to a very low level in order to achieve cooling of the tissue within the fastest possible time. Alternatively, a very low power of 1 Watt may be output to the tissue in order to continue to keep the electric circuit closed via the tissue. Such a low power output does not delay the cooling process.
The most homogeneous possible structure is to be achieved in the coagulated tissue. The achievement of a homogeneous tissue structure and a simultaneously short sealing period are in a target conflict. It is the object of the invention to state a concept with which the homogeneity and thus the reliability of the seal can be improved and the sealing time can be shortened.
The generator according to the invention generates a coagulation voltage for operating the instrument for tissue fusion in several stages. To do so, the generator is disposed to first heat the tissue to the boiling temperature of the tissue fluid during a first stage, so that steam may form. As soon as the tissue has been sufficiently heated, the device moves into a second stage according to a first aspect of the invention. In it, the oscillation of the tissue resistance is triggered. In this phase, the tissue resistance assumes alternatingly high and low values. After high tissue resistances with relatively dry tissue or steam bubbles in the tissue and low tissue resistance with moist tissue or tissue without steam bubbles have been associated, it is not only the tissue resistance that oscillates but the tissue condition also pulses, thus potentially resulting in a pulsing stress of the tissue. Furthermore, by periodically reducing the electrical energy input into the tissue, it is possible to achieve a moisture increase, steam elimination or steam liquefaction (e.g., due to condensation or escape of steam). Consequently, it is possible to effect a lowering of the resistance of the tissue and thus, effectively and/or in total, achieve an increased total energy input. The periodic reduction of the tissue resistance effects an increased current flow between the electrodes—compared to coagulation processes, wherein the operation is performed at constant high tissue resistance.
For oscillating control of the tissue resistance, a nominal resistance curve can be determined, wherein the function block comprises a regulator for the tissue resistance. The regulator measures the tissue resistance—continuously or within a narrow time grid—and compares this tissue resistance with the tissue resistance currently specified by the nominal tissue resistance curve. Based on the resultant deviation, the regulator determines the voltage to be applied to the tissue and delivers said voltage to the coagulation electrodes which thus receive a high-frequency coagulation voltage that is amplitude-modulated at a low frequency. Its value oscillates at a few Hertz, preferably less than 30 Hz (or less than 20 Hz), further, preferably less than 20 Hz or also less than 10 Hz. In many cases, a good effect is achieved with an oscillation frequency between 10 Hz and 20 Hz. The oscillation frequency may be specified in a fixed manner by an appropriate function block or be specified in a variable manner by the function block—in particular also as a function of the generator setting, of the grasped tissue and, in particular, as a function of the instrument. Consequently, the oscillation frequency can assume different values adapted to the situation at hand.
Preferably, the regulator comprises an output voltage limiting device that sets a maximum voltage and/or a minimum voltage during the oscillation of the tissue resistance. Preferably, the maximum voltage is set in such a manner that a spark formation during phases of high tissue resistance or an otherwise thermal damage to the tissue to be coagulated, as well as to the surrounding tissue, does not occur. For example, the maximum voltage may be set at a value between 80 V and 150 V, preferably 90 V to 120 V. Deviating values are possible. The minimum voltage is preferably set at a value different from zero. In this manner, a cooling of the tissue that is too fast and a condensation of the steam in the tissue that is too fast can be prevented. For example, the minimum voltage is within a range of 20 V to 40 V.
Preferably, the function block is disposed to end the resistance oscillation at a tissue resistance that is too high in order to then transition into a controlled cooling process during a third stage, said cooling process representing a second aspect of the invention. During the controlled cooling process, a current is continuously applied to the tissue at a voltage whose amplitude decreases over time, as a result of which the cooling of the tissue that would otherwise processed vary rapidly is clearly slowed. Due to the continuous application of current to the tissue grasped between the electrodes, cooling of the tissue is clearly slowed compared with the intermediate cooling to be observed during oscillation, as a result of which the temperature gradient prevailing in the tissue is decreased. Zones that pass through temperatures that are optimal for protein chaining during the cooling process are increased as a consequence of the decreased temperature gradient in the tissue. As a result of this, the involved proteins, in particular collagens, are given more time and more space for forming mechanically durable, optionally also fibrous, structures. Proteins—in particular collagen—of opposing tissue walls that are pressed against each other are able to fuse together.
Although the slowed cooling process results in a longer cooling period, the sum of the time required for the coagulation with resistance oscillation and controlled cooling is less than would be required with a coagulation without resistance oscillation and with uncontrolled cooling. Thus, an abbreviation of the time for coagulation is possible, so that a total of less than 3 sec, in particular less than 2 sec, of treatment time—including the cooling process—can be achieved. Although the time from closing the branches of the instrument to reopening same is so short, secure sealing of the vessel and thus a high-quality surgical outcome can still be achieved.
In order to determine the procedure status and, in particular, to determine the starting and end points of the different stages, a function block can monitor at least one tissue property. Such a tissue property may be the voltage applied to the tissue, the current flowing through the tissue, the applied power, the amount of energy transmitted to the tissue, the tissue resistance or the like. For example, during the first stage at the start of the application of current, the tissue resistance typically experience a phase of decrease, whereupon it passes through a minimum and then increases again. The re-increase is connected to the formation of steam in or on the tissue. According to a first aspect of the invention now, during the second stage of the coagulation process, oscillations of the tissue resistance are generated. This can be accomplished, e.g., by specifying a setpoint curve for the tissue resistance. The coagulation voltage applied to the tissue is dimensioned by means of a regulator in such a manner that the tissue resistance behaves approximately in accordance with the specified setpoint curve. If the oscillations have occurred over a specified time (for example, approximately 0.5 sec) or if a certain number of oscillations (for example, 5 to 6, preferably 7 to 10, preferably 8) have been registered, the third stage may be initiated, said stage representing a slowed cooling process.
The resistance oscillations and/or the slowed cooling allow a fusion of blood vessels with increased safety. The resistance oscillations result in a pulsed energy input into the tissue with periodic remoistening of the tissue due to condensation of the insulating steam and therefore to increased energy input. An intimate connection of the oppositely located, pressed-together tissue walls is prepared. The delayed, i.e., slowed cooling process then provides a good recombination and protein chain formation of the involved proteins, in particular the collagen. The slowed cooling process provides larger zones in the biological tissue in which—during the cooling phase—optimal temperature conditions for the formation of long, interlinked protein chains are obtained.
Further details of advantageous embodiments of the inventive generator as well as of the inventive control method can be inferred from the description, as well as from the dependent claims and the appended drawings. They show in:
At least one of the branches 13, 14 is movable in order to be able to compress the tissue 12 grasped in between them as illustrated in
The device 10 comprises a generator 15 that provides, at an output 16, a high-frequency coagulation voltage HF that, optionally is conducted via a sensor block 17 and the lines 18, 19 to the instrument 11. The sensor block 17 is disposed to detect the intensity of the RF voltage delivered by the generator 15 and/or of the RF current delivered by the RF generator and deliver these as signals u and/or i to a function block 20 or to several function blocks 20a, 20b (see
The generator 15 has an input 21 via which the generator 15 is able to receive control signals. These may be analogous or digital signals that specify the intensity of the coagulation voltage u output by the generator 15. The control signals may be delivered by a function block 20 that is connected to the sensor block 17, so that the latter receives signals output by said function block. The signals may for example be signals that characterize the RF current delivered by the generator 15 and/or the RF voltage provided by the generator 15. The function block 20 may be divided into two or more function blocks 20a, 20b.
The function block 20 or the function blocks 20a, 20b may be configured as separate building blocks or as program component(s) of a generator control program or be made of any suitable other means with which the operation of the generator 15 can be controlled. They form a regulator for a parameter that is to be regulated in a stage-regulated manner; this may be, for example, the current i (e.g., in stage A), the tissue resistance R (e.g., in stage B), the coagulation voltage u (e.g., in stage C), or the power P (e.g., also in stage C). The regulator may be set to control the generator 15 during at least one of the stages within voltage limits that are fixed, chronologically constant or follow the desired progression over time. Additionally or alternatively, the regulator may be set to control the generator 15 during at least one of the stages within the current limits, resistance limits or output limits that are fixed, chronologically constant or follow a nominal progression over time. The desired progressions over time may be increasing or decreasing ramps or other regular or irregular periodic or non-periodic functions.
For a better illustration of the structure and the functionality of the function block 20, reference is made to the exemplary embodiment according to
The function block 20b receives—depending on the operating mode or stage of the coagulation process—at least one of the signals that characterize the tissue resistance R, the power P output to the tissue, the phase shift Phi between the coagulation voltage u and the current i, the coagulation voltage u and/or the current i that flows through the tissue. The function block part 20b of the function block 20 controls the coagulation process in that it specifies in each stage a setpoint curve for at least one of the parameters R, P, Phi, u, i, said curve being accessible, for example in a memory 22. The setpoint curve may contain several sections, each being applicable to one (or more of the parameters R, P, u, i and specifying the respective setpoint value for this parameter. Depending on the type of connected instrument 11 or depending on the adjustment at a user interface of the device 10, the setpoint(s) may vary.
Furthermore, the function block 20b comprises a regulating block that determines the difference between the respective parameter (R, P, Phi, u or i) specified by the setpoint curve and the actual value of the respectively controlled parameter R, P, Phi, u or i determined by the function block 20a. Based on this setpoint/actual difference, a setpoint voltage is derived within the function block 20b by the regulating block and output to the generator 15.
The control blocks 20a, 20b may be part of a program processed by the controller, said program functioning as follows and controlling the generator 15 as follows:
The generator 15 is capable of generating a high-frequency coagulation voltage within the range of several 100 kHz, for example 350 kHz. The voltage generated by the generator 15 may be, for example, within the range of 0 to 150 V. Other generator voltages can be used. However, in any event the voltages are such that a spark formation between the branches 13, 14 and the biological tissue, for example a blood vessel 12, does not occur. Furthermore, the generator 15 is preferably configured in such a manner that it can provide an output of up to 120 W, for example, or more. Furthermore, it is configured in such a manner that it can deliver an RF current of 2 A (or higher). With these parameters, the generator 15 is basically suitable for the fusion of the blood vessel 12 or another tissue, i.e., for the permanent closure of said vessel or tissue by means of the instrument 11.
The blood vessel 12 has a tissue endothelium 24 that forms the inner lining, i.e., the Tunika interna, of the blood vessel 12. The tissue endothelium consists of endothelial cells that form a single-layer plate epithelium, elastic fibers and connective tissue. This is seated on a middle layer 25—also referred to as the Tunika media—that consists of muscle cells, collagen fibers, elastic fibers and connective tissue. The outer layer 26—also referred to as the Tunika externa—consists mainly of connective tissue and elastic fibers. In particular the Tunika media and the Tunika externa contain collagen fibers that are to be fused together during tissue fusion.
In order to perform the tissue fusion procedure, the vessel 12 is first grasped between the branches 13, 14 and compressed in accordance with
According to
While the current increase occurs, the tissue resistance R shown in
As an alternative to this type of control, it is also possible for the coagulation voltage u to follow a specified time-based function, e.g., as a ramp, in stages or the like. This can be specified by the function block 20b via the chronologically appropriately occurring setpoint voltage.
During the first stage, the tissue resistance R decreases—as the current increases and heating increases—initially to a value Rmin—that, typically, is below 50 Ohm. Due to the increasing tissue temperature, the ohmic resistance R of the biological tissue decreases to very low values such as, for example, hardly more than 20 Ohm, in many cases even below 10, 5 or 2 Ohm. As heating of the tissue increases and steam formation sets in, the tissue resistance R increases again, as can be seen at point 29 of
At this time (at approximately 1 sec) the power P transmitted to the vessel 12 has exceeded its maximum and decreases due to the increasing resistance as a consequence of increasing steam formation and tissue desiccation, respectively. In the present exemplary embodiment, the energy W transmitted to the vessel 12 has reached approximately 50 J at this time. Alternatively, it is possible to provide other energy values.
The function block 20b can be configured in such a manner that it determines the method status in view of elapsed time, alternatively in view of the electrical energy W transmitted to the vessel 12, alternatively in view of the size and/or chronological progression of the tissue resistance R, or further alternatively, in view of the size and/or the chronological progression of the current i. A characteristic value for the method status is the beginning boiling of the tissue fluid which is accompanied by the fact that at least parts of the vessel 12 have reached boiling temperature. If the function block 20b monitors the current, this may be detected by the function block 20b in view of the current curve 27. If the function block 20b monitors the energy W transmitted to the vessel 12, the function block 20b can detect the beginning boiling of the tissue fluid by reaching a certain amount of energy (for example Watt seconds) transmitted to the vessel 12. If the function block 20 monitors the tissue resistance R, said function block is able to detect the beginning boiling of the tissue fluid by exceeding a resistance limit of 42.5 Ohm, for example, after passing through a resistance minimum.
Independently of the fact which of the said parameters is monitored by the function block 20, 20b, the latter detects—as the functions status—the end of stage A (e.g., by the beginning boiling of tissue fluid in view of the resistance R) and now guides the generator 15 into a tissue fusion phase that, preferably, lasts for half a second or minimally longer. During this phase, the generator 15 can be controlled by the function block 20b in such a manner that it generates the coagulation voltage u and the tissue resistance R with a chronological setpoint value progressing in accordance with a specified function 32 and periodic voltage decreases or voltage dips 32 to 39. The specified maximum value of the coagulation voltage u may be chronologically constant or, as inferred by
In stage B the function block 20b preferably acts as the regulator for the tissue resistance R. To do so, the memory 22 specifies a setpoint time function for the setpoint tissue resistance R5011 and delivers this function to the regulator block. For example, this setpoint time function is a periodic, time-dependent function, e.g., a sine function that is shown in a dashed line in
As a result of the regulation of the tissue resistance, voltage dips 32 to 39 occur in accordance with
As a result of the periodic resistance modulation, already generated steam and/or tissue of the vessel 12 can remoisten again. There result pressure pulsations consistent with resistance oscillations illustrated by
The function block 20 can specify the method status of the vessel 12, for example in view of a time curve for the progression of the tissue resistance with a firmly or variably specified number of oscillations of the tissue resistance R or the voltage dips 32 to 39. Alternatively, it is also possible to specify the oscillations with amplitude and frequency and to detect the number of voltage dips 32 to 39 or the resistance oscillations. To accomplish this, the performed voltage decreases can be counted and, when a limit of 8 or 9, for example, is reached, stage B can be completed. In any event, stage B ends at a high tissue resistance and thus also at a high (not reduced) coagulation voltage u. Similarly, in a further modified embodiment, the function block 20 can monitor and count the output maxima and/or output minima according to
If the function block 20 determines in any of the previously described ways that the second stage B is completed, the function block 20 changes the actuation of the generator 15 in such a manner that it enters a controlled tissue cooling phase, stage C. In it, the vessel 12 is continued to be supplied with current in order to slow tissue cooling in a targeted manner. Consequently, according to
The coagulation voltage u is decreased at a specified rate of −200 V/sec, for example. It is also possible to use other decreasing rates (for example −150 V/sec or −250 V/sec. Furthermore, the decreasing rate may be varied during the cooling phase, if desired.
During the cooling phase a remoistening of the tissue occurs, in which case the tissue moves—in zones—in a cooling manner through different temperature ranges of approximately 150° C. to 170° C. This is accompanied by a decrease of the tissue resistance R, which, however, due to the contused application of current, is clearly slower than the resistance decreases during the resistance oscillations in stage B. As a result of this, the temperature gradient in the biological tissue is minimized by the slowed cooling—compared with a non-slowed cooling. Zones having a relatively large volume are formed with extended duration of existence, their temperature being located in a temperature window that is favorable for protein chaining. Consequently, there is more time available for the formation of mechanically durable protein structures for each point of the involved tissue.
With the increasing elimination or evaporation of the steam, the tissue resistance R decreases to below a limiting value. This limiting value may be a specified limiting value or, alternatively, a limiting value that results from the tissue resistance during the resistance oscillations or from the resistance progression from stage A. For example, because of the minimum voltage of the generator 15, below which it is not possible to drop, the tissue resistance in stage B does not decrease as far as specified by the resistance setpoint curve. However, the occurring minimum tissue resistance Rmin can be registered. When the tissue resistance R reaches the registered minimum tissue resistance Rmin or a fixed multiple thereof (e.g., 1.5*Rmin), this can be used as the event for ending the voltage-guided cooling phase of stage C. At this time te the function block 20 switches to output regulation. The tissue is now supplied with such a coagulation voltage u that the power P, as shown by
Alternatively, the limiting value of the resistance may also be that value Rmin which is reached by the tissue resistance as the minimum before its increase 28 and/or that value to which the tissue resistance falls during the voltage dips 32 to 39. The function block 20, 20b can detect this value and put it in memory in order to use it for the detection of the end of the cooling phase as limiting value.
The device 10 according to the invention and the method concept according to the invention each allow a particularly fast, gentle and secure fusion of vessels 12 between two coagulation electrodes 13, 14. In doing so, resistance oscillations are generated in the biological tissue, said oscillations alternatingly moving above and below a tissue resistance value of, e.g., 50 Ohm. Subsequently, a phase of slowed tissue cooling is passed, during which phase a current is applied to the tissue 12 with preferably chronologically decreasing coagulation voltage in order to achieve a substantially slowed cooling process compared to an instant voltage disconnection. In doing so, a good fusion of the collagen of the pressed-together vessel walls is achieved on the one hand and a mechanically stable solidification of the collagen is achieved on the other hand. Due to the mentioned process control, the required fusion time is shortened compared to conventional methods, the undesirable damage to surrounding tissue is reduced because of the shortened time of action of the high-frequency current, and the closure of the vessel is more secure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2017 106 747.7 | Mar 2017 | DE | national |
