Patent Application
20230012481
The present invention relates to an insufflation apparatus intended to expose structures within a cavity of the human body, by insufflating gas into that body cavity, to obtain a field of vision, through the endoscope, to perform a diagnostic and/or therapeutic endoscopic procedure to that structure in the body cavity. The apparatus further relates to a computer-controlled method of operating an insufflator intended to expose structures within a cavity of the human body for a diagnostic and/or therapeutic endoscopic procedure.
The application of minimal access surgery, allowing surgery through a few small incisions by introduction of a camera and instruments, has become the standard for most surgical procedures. In the thorax and abdomen a surgical field is created by the insufflation of e.g. carbon dioxide gas to the desired pressure level.
Gas insufflation for minimal access surgery was developed in the 1950's. First oxygen, and the carbon dioxide gas was insufflated under pressure into the abdominal cavity in order to create surgical workspace. Insufflation devices apply a set pressure and gas flow in order to create and maintain the required gas volume. This concept has remained unchanged to date in clinical practice. Insufflators have very limited 25 adaptation abilities to cope with pressure changes originating from the patient. As a consequence the insufflated gas volume is relatively constant. It is known that the pressure that is applied to the body cavity influences the balance of pressures within the body. For example the pressure required for ventilating the lungs of a patient during a surgical procedure is opposed by the pressure created by the insufflation device. Another well-known effect is on haemodynamics, caused by the fact that venous blood pressures are typically lower than commonly used insufflation pressures. As a consequence venous return is impaired, affecting systemic circulation.
Current insufflators use high-pressure insufflator gas sources and inject the gas into the cavity by controlling the inflow by a valve. As these pneumatic systems have a very high impedance for the outflow gas (i.e. they do not permit return flow), all insufflators need a release valve that opens in the case the pressure inside the cavity increases over the pre-set one. Because of this arrangement, rapid pressure variations occurring in the cavity due to, for example, mechanical ventilation, coughing or similar, cannot be dynamically compensated and, therefore, large rapid pressure variations are commonly observed in the cavity.
In an aspect of the invention there is provided an insufflator apparatus for exposing structures within a cavity of the human body for a diagnostic and/or therapeutic endoscopic procedure, comprising: an insufflation gas supply, adapted to provide insufflation gas to a pressure regulator; the pressure regulator, adapted to supply insufflation gas into the cavity of the human body via an input mechanism attachable to the human body, a means for determining a pressure level in the body cavity; an insufflator vent mechanism adapted to release excess insufflation gas volume returning from the pressure regulator; an insufflator controller arranged to real time adapt an insufflation rate of said insufflator gas via said gas supply and vent mechanism at a set average pressure level in the body cavity in accordance with the means for determining the pressure level in the body cavity; and wherein the pressure regulator has a limited volume for temporarily storing a gas returning from the body cavity to thereby avoid transient pressure deviations from the set average pressure level in the body cavity, e.g. due to coughing or mechanical ventilation and allowing the gas to return to the body cavity to maintain the set average pressure.
The invention allows to keep insufflation pressure highly constant within the body cavity by allowing flow moving in and out of the surgical workspace (the ‘body cavity’) at a low impedance effectively provided by the pressure regulator. This allows accommodating for any rapid change in body cavity pressure as a consequence not only to the tidal changes of ventilation pressures but also to coughing or any other reason. The added value of this is a reduced burden of insufflation on patients' ventilation and haemodynamics without the need of the insufflator to be synchronised to the mechanical ventilator. This invention leads to a stand-alone insufflation device able to implement a fast compensation of surgical space pressure perturbation without requiring interfacing to other devices or connections to breathing circuits. Moreover, the presence of a gas reservoir allows maintaining a stable pressure in the body cavity while minimizing the venting of insufflation gas.
Embodiments of the invention will now be described, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, and in which:
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs as read in the context of the description and drawings. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. In some instances, detailed descriptions of well-known devices and methods may be omitted so as not to obscure the description of the present systems and methods. Terminology used for describing particular embodiments is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term “and/or” includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms “comprises” and/or “comprising” specify the presence of stated features but do not preclude the presence or addition of one or more other features. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control.
The term “insufflator” is used to denote a device for exposing by insufflation of pressurized gas structures within a cavity of the human body for a diagnostic and/or therapeutic endoscopic procedure. Exemplary body cavities may be the thoracic or abdominal cavity. By insufflation, it is meant to insufflate an insufflator gas, most commonly CO2 at controlled gas flow, gas output volume and/or gas output pressure in particular. The instantaneous pressure may be measured at sample rates of 0.1-500 Hz or even higher sample rates at least with a wave recognition up to 20 Hz in order to suitably predict and control the dynamics of the insufflated gas and dynamic response of the human body and body wall during gas insufflation. In the examples, insufflation may also encompass exsufflation, i.e. active removal of (part of) the insufflated volume.
The term ‘insufflation rate’ may denote a physical parameter, such as pressure, volume, temperature and frequency, that is adjusted in accordance with an instantaneous inflated lung volume, by means of hard-wired coupling with the ventilator or high-frequency internal or external pressure- and/or flow sensors.
Both the insufflator gas and the ventilation gas may be conditioned, e.g. humidified by using a humidifier or brought to a certain temperature by a heating installation. The term ‘real time’ is indicated to substantially continuously measure and control, in contrast to isolated control that has a sample frequency larger than a breathing frequency. Typically, for real time measurement and control, a sample frequency of at least twice the breathing frequency is desirable.
The “insufflator controller” may be a dedicated processor for performing in accordance with the present system or may be a general-purpose processor wherein only one of many functions operates for performing in accordance with the present system. The processor may operate utilizing a program portion, multiple program segments, or may be a hardware device utilizing a dedicated or multi-purpose integrated circuit. Any type of processor may be used such as dedicated or shared one. The processor may include micro-controllers, central processing units (CPUs), digital signal processors (DSPs), ASICs, or any other processor(s) or controller(s) such as digital optical devices, or analog electrical circuits that perform the same functions, and employ electronic techniques and architecture. The controller or processor may further comprise a memory that may be part of or operationally coupled to the controller. The memory may be any suitable type of memory where data is stored. Any medium known or developed that can store and/or transmit information suitable for use with the present systems and methods may be used as a memory. The memory may also store user preferences and/or application data accessible by the controller for configuring it to perform operational acts in accordance with the present systems and methods.
The disclosed system is intended for exposing an intended structure within a cavity of the human body for therapeutic and/or surgical treatment, using insufflator 100. The insufflator comprising an insufflator input mechanism 60 adapted to input the gas from the gas supply G into a cavity of a human body. In the gas supply G a gas container may be present, wherein a suitable insufflation gas is stored, or the gas can be supplied via an external gas supply, e.g. a wall socket.
The pressure regulator 11 comprises a gas reservoir which may provide in- and exsufflation by mechanically changing its volume for temporarily storing a gas returning from the body cavity to avoid transient pressure deviations from the set average pressure level in the body cavity. An insufflator controller 30 is provided for setting and maintaining a pre-defined gas pressure in the cavity by compensating the fast transient pressure changes, firstly with the pressure regulator 11 and secondly with the supply valve 14 and vent mechanism 13. The insufflator controller 30 is provided for enlarging the cavity by the insufflation of gas from the gas supply G into the cavity.
The described invention is implementing a two-way low impedance gas pressure supply, which inherently permits easy gas flow in and out of the cavity, regardless of the origin of the pressure change that causes the gas flow. The insufflation system 100 may compensate for transient pressure changes in the cavity due to breathing, being totally independent, e.g. from the mechanical ventilator. Therefore, it does not need any means to synchronize to it and, consequently, can be used in combination of all existing and future mechanical ventilators. In principle, the low impedance gas supply may be passive, but it is advantageous when the compliance mechanism is controlled by the insufflator controller as a function of the measured pressure variations in the body cavity since then, faster response times and low pressure peaks can be attained by actively control of the compliance mechanism, e.g. under control of the insufflator controller 30. The compliance mechanism has a limited volume, of e.g. 250 milliliters up to more than 5 liters, for storing, i.e. buffering and enabling return of gas flow from and to the body cavity. This provides a convenient way of countering pressure variations, while at the same time preventing that insufflator gas is released by the vent mechanism. A limited volume may be a non-fixed volume that varies between a minimum and maximum volume.
Embodiment 4, shown in
Embodiment 5 shown in
Embodiment 7, depicted in
Similarly, in
The present invention may have following advantages. This invention entails a system that allows gas flowing in and out of the body cavity through a pressure generator that has an effective low impedance, allowing for automatic fast compensation for changes in the cavity pressure that are caused by whichever events such as mechanical ventilation, coughing, etc, while maintaining a constant insufflation pressure. The unique point of this technology is its fast adaptation to any changes in pressure by allowing a low impedance two-way gas flow to maintain the cavity pressure constant (and not allowing deflation only as consequence of overpressure) by limiting the release of insufflation gas. There are several other advantages:
In interpreting the appended claims, it should be understood that the word “comprising” does not exclude the presence of other elements or acts than those listed in a given claim; the word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements; any reference signs in the claims do not limit their scope; several “means” may be represented by the same or different item(s) or implemented structure or function; any of the disclosed devices or portions thereof may be combined together or separated into further portions unless specifically stated otherwise. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage. As described above, the exemplary embodiments can be in the form of computer-implemented processes and apparatuses for practicing those processes. The exemplary embodiments can also be in the form of computer program code containing instructions embodied in tangible media, such as floppy disks, CD ROMs, hard drives, or any other computer-readable storage medium, wherein, when the computer program code is loaded into and executed by a computer, the computer becomes an apparatus for practicing the exemplary embodiments. The exemplary embodiments can also be in the form of computer program code, for example, whether stored in a storage medium, loaded into and/or executed by a computer, or transmitted over some transmission medium, loaded into and/or executed by a computer, or transmitted over some transmission medium, such as over electrical wiring or cabling, through fiber optics, or via electromagnetic radiation, wherein, when the computer program code is loaded into an executed by a computer, the computer becomes an apparatus for practicing the exemplary embodiments. When implemented on a general-purpose microprocessor, the computer program code segments configure the microprocessor to create specific logic circuits.
While the invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out this invention, but that the invention will include all embodiments falling within the scope of the claims. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2024352 | Dec 2019 | NL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/NL2020/050752 | 12/2/2020 | WO |
