vacuum system for endoscopic vacuum therapy and endoscopy arrangement

专利摘要:
VACUUM SYSTEM FOR ENDOSCOPIC VACUUM THERAPY AND ENDOSCOPY ARRANGEMENT A vacuum system for intracavitary, intraluminal or intracorporeal endoscopic vacuum therapy for aspirating body fluids, wound secretions or gases from a hollow volume as a cavity is described. a hollow organ, a tissue abscess or an intestinal lumen, especially in the manufacture of a transient endoscopic closure of an intestinal lumen. In this context, numerous ways of implementing an endoscopy arrangement are described.
公开号:BR112013023118B1
申请号:R112013023118-1
申请日:2012-03-12
公开日:2021-01-26
发明作者:Gunnar Loske
申请人:Lohmann & Rauscher Gmbh & Co.Kg；
IPC主号:

专利说明:

[0001] [001] The present invention relates to a vacuum system and an endoscopy arrangement for endoscopic vacuum therapy, especially for intracorporeal, intraluminal or intracavitary vacuum therapy. BACKGROUND OF THE INVENTION
[0002] [002] Endoscopic research of the upper and lower gastrointestinal tract (esophagogastroduodenoscopy / rectoscopy, sigmoidoscopy, ilescopy, (endoscopy of the small intestine) are routine diagnostic and therapeutic tests.
[0003] [003] The investigation of the middle intestinal tract, especially the small intestine is difficult by endoscopy, since it is very long and very mobile. For an extra-long endoscopy for the so-called Pushenteroscopy, the so-called single-balloon and double-balloon enteroscopy are used on the one hand. The latter used for better advancement of the endoscope balloon systems in the endoscope and / or overtube, which are filled and can be compressed can within the intestinal wall. In this way, the endoscope or Overtube can be attached to the intestinal wall and thus a deeper search of the intestine can be obtained. Another possibility of researching the intestine lies in the photographic documentation through an ingestible videocapsule.
[0004] [004] Conventional endoscopic vacuum assisted therapy (negative pressure wound therapy) is employed for the treatment of external wounds. An open-pored polyurethane sponge or other fluid-collecting medium is placed on the wound, sealed with a film and then subjected to negative pressure. In this case, wound cleansing and wound healing. DESCRIPTION OF THE INVENTION
[0005] i) para apurar levando-se em contra um volume morto prédeterminado do arranjo de drenagem a vácuo conectável à bomba a vácuo um primeiro desempenho de sucção da bomba a vácuo necessário para o estabelecimento da pressão negativa pré-determinada no volume oco a ser tratado do intervalo de tempo de evacuação pré-definido e conduzir para a entrada de controle da bomba a vácuo um primeiro sinal de controle correspondente, ii) para monitorar após o estabelecimento da pressão negativa prédeterminada no volume oco a ser tratado, o sinal de medição de pressão e apurar em função do sinal de medição de pressão atual um segundo desempenho de sucção bomba a vácuo necessário para a manutenção da pressão negativa prédeterminada e conduzir à entrada de controle der bomba a vácuo um segundo sinal de controle correspondente; e iii) após estabelecimento da pressão negativa pré-determinada no volume oco a ser tratado com a presença de um desvio que ultrapassa um valorlimite pré-definido da pressão medida ou da pressão negativa apurar um terceiro desempenho de sucção da bomba a vácuo necessário para o estabelecimento da pressão negativa pré-determinada dentro do intervalo de tempo de evacuação pré-determinado e emitir um terceiro sinal de controle à entrada de controle der bomba a vácuo; sendo que - a bomba a vácuo é projetada, no lado de pressão negativa em função do sinal de controle no momento junto à sua entrada de controle para produzir m desempenho de sucção determinado pelo sinal de controle.[005] In accordance with a vacuum system according to the invention for intracavitary, intraluminal and intracorporeal vacuum therapy an intestinal lumen is proposed for aspiration of body fluids, wound secretions or gases from the hollow volume as from a body cavity , a hollow organ, a tissue abscess or an intestinal lumen, especially for the production of an endoscopic closure of an intestinal lumen. The vacuum system comprises: - a vacuum pump, which has a Control input for receiving a control signal to control its suction performance and has a connection for the vacuum drain arrangement on the negative pressure side. - a pressure regulating unit that can be connected or connected to the vacuum pump control input, - which has a measurement signal input for receiving at least one pressure measurement signal, which forms a measurement for a prevailing negative pressure or pressure in the hollow volume to be treated, - and that is designed, according a) a negative pressure value in the hollow volume to be treated, which can be selected from a range of predefined negative pressure values e. b) an evacuation time interval, which can be selected between 0.5 and 5 seconds of the value in question, i) to determine against a predetermined dead volume of the vacuum drainage arrangement connectable to the vacuum pump a first suction performance of the vacuum pump necessary for the establishment of the predetermined negative pressure in the hollow volume to be treated from predefined evacuation time interval and conduct a corresponding first control signal to the vacuum pump control input, ii) to monitor after establishing the predetermined negative pressure in the hollow volume to be treated, the pressure measurement signal and to determine, according to the current pressure measurement signal, a second vacuum pump suction performance necessary to maintain the negative pressure predetermined and lead to the vacuum pump control input a second corresponding control signal; and iii) after establishing the pre-determined negative pressure in the hollow volume to be treated with the presence of a deviation that exceeds a pre-defined limit value of the measured pressure or negative pressure, determine a third suction performance of the vacuum pump necessary for the establishment the predetermined negative pressure within the predetermined evacuation time interval and emit a third control signal at the vacuum pump control input; being that - the vacuum pump is designed on the negative pressure side as a function of the control signal at the moment next to its control input to produce a suction performance determined by the control signal.
[0006] [006] In the following will be presented in more detail principles based on the present invention, then examples of embodiment will be presented.
[0007] [007] The invention relates to the knowledge that vacuum therapy experiences on external wounds are not applicable in the case of endoscopic vacuum therapy. Based on this, it recognizes a rapid establishment of the vacuum with a short evacuation period as an essential technical prerequisite, which can decide on the success of an endoscopic vacuum therapy.
[0008] [008] The requirements for a vacuum pump unit for endoscopic vacuum therapy can be specified according to the invention as follows: the negative pressure adjacent to a fluid collecting element must be quickly high enough that the collecting element of fluid can be sucked firmly into the surrounding tissue. The vacuum cannot be too high so that it can reach a draining action on the surrounding tissue through an open pore structure of a fluid collecting element to be connected. It must not injure the tissue aspirated through, it must enter through the inciting effect. In such cases there is a lack of sufficient draining action on the wound.
[0009] [009] The suction performance of the vacuum pump is therefore according to the invention dimensioned in such a way and adjustable by means of the pressure regulation unit that a vacuum defined under these marginal conditions can be established and kept constant in a short time or at a high speed. The therapy would be ineffective if the parameters related to the establishment of a vacuum would not correspond to the specific requirements. Only in the case of rapid establishment of rapid vacuum and maintenance as well as in case of need for rapid restoration of the vacuum, for example in the case of a typical indication for treatment, namely treatment of esophageal lesions, would a closure of the valve be performed at the same time. perforation defect and wound drainage. Permanent occlusion and drainage opposite to physiological negative intrathoracic pressure in the direction of the esophageal lumen interrupts contamination by saliva or secretion in the direction of the chest cavity and thus acts as a barrier against infection. In the event of a longer vacuum setting and even in the case of short interruptions of the predetermined negative pressure, a displacement of a fluid collecting element may occur. The interrupted and ineffective Sog at the base of the wound causes a paralysis of the therapy or a worsening of the situation of the wound. In the case of an intraluminal treatment in the esophagus in the event of a perforation of the esophagus with the loss of negative pressure, a strong ingested secretion may enter between the wall of the esophagus and the fluid collecting element and cause a clogging of the pores and thereby interrupting the therapy. In the case of other possibilities of application in the small intestine or large intestine with insufficient pressure parameters, pore clogging through small intestine and large intestine feces may occur.
[0010] [010] In the case of endoscopic vacuum therapy according to the knowledge of the present invention, a permanent negative pressure is established in the wound and a fall in the negative pressure under the therapy is avoided. In the event of a negative pressure drop which is sometimes unavoidable, the vacuum is restored via the vacuum system according to the present invention very quickly. For example, when placing a sponge drainage in the esophagus through the act of physiological sip, a vacuum drop occurs both through the ingestion of saliva, food, air and gas, but also peristaltic bowel movements. The same applies for the application of vacuum therapy in the small intestine, large intestine or stomach or throughout the intestine.
[0011] [011] Unlike vacuum therapy on external wounds, in the case of endoscopic vacuum therapy there is no possibility of visual or tactile control if negative pressure is present in the fluid collecting element and in the internal wound since the fluid collecting element is not it can be seen more below the body surface after placement. A stop in therapy will occur or the therapy will be ineffective if Sog's action on the wound is established too slowly or if it is interrupted. An interruption of Sog can occur, among other things, also through the clogging, curve or breakdown of the fluid communication element or the fluid collecting element. Also in the case of a very high vacuum, clogging of the open pore structure can occur through tissue aspiration and in the case of an elastic fluid collecting element, a complete collapse of the fluid communication element can occur with suspension of the action of Sog in the tissue. . Only through the characteristics specified in the invention of the vacuum system according to the invention is effective internal vacuum therapy possible.
[0012] [012] In the case of viable endoscopic vacuum therapy through the invention, it is a negative pressure therapy performed with a flexible endoscope and endoscopic perspective and with the help of endoscopic techniques of internal walls and the vacuum drainage in cavities (intracavitary) Intestinal (intraluminal) lumina can be placed through natural or artificial intracorporeal body holes in cavities. With the vacuum system according to the invention, endoscopic vacuum therapy of internal walls is also possible, which without being treated can lead in part to high mortality and often require complex and surgical treatment.
[0013] [013] Unlike vacuum therapy on external walls, in the case of intracorporeal, intracavitary, intraluminal, endoscopic vacuum therapy, the vacuum system of the present invention is obtained only through the opposite accumulation of wound tissue and soft tissues around the fluid collecting element, which is connected in the surgical actuation in a fluid conducting way through fluid communication elements with the vacuum pump of the vacuum system according to the invention, after application of the negative pressure, a closing of internal wound. Through this wound closure the closed compartment is formed as tightly as possible, which enables permanent production and vacuum maintenance. The hollow compartment, in which the fluid collecting element is located, is emptied by suction and collapsed under vacuum through the fluid collecting element. If the fluid collecting element is elastically constructed, it also collapses under vacuum. With the help of the vacuum pump of the vacuum system according to the invention, a suction effect is generated in the wound, which is then closed. Fixation of the fluid collecting element at the placement site occurs only by suction on the adjacent tissue or on the mucous membrane.
[0014] [014] Unlike vacuum therapy on external wounds, in which a closure is performed using a film occlusion bandage, closure in endoscopic vacuum therapy that occurs only as a result of the vacuum through the very close tissue is less stable. The closing and, therefore, also the fixing of the fluid collecting element are made exclusively by the fact that the fluid collecting element is adhered by suction by vacuum by suction cup in the fabric and the vacuum is kept permanent and constant. That is why it is the knowledge base of the invention that for a successful endoscopic vacuum therapy to be carried out, a vacuum system must meet the requirements set and monitored by the pressure regulation unit.
[0015] [015] For the establishment of a vacuum for the purpose of performing a vacuum endoscopy, in the vacuum system according to the invention a vacuum pump is provided whose suction performance can be controlled and is designed to generate within a range of short, and defined evacuation time between 0.5 and 5 seconds a pre-determined negative pressure at the application site and thus keep it at a constant value.
[0016] [016] The invention furthermore relates to the knowledge that another parameter of influence, namely the volume of the wound cavity to be evacuated or the intestinal lumen is negligible. On the other hand, it is verified that in constant volumes to be evacuated (fluid collecting element, fluid communication element, secretion container) the speed of the entrainment structure in the relevant area of the negative pressure with known volumes of the secretion collecting container is controllable practically solely by the suction performance of the vacuum pump (liter / minute). As the secretion collection container can be filled with secretion, the dead volume decreases. This can also be measured and the suction performance can be automatically adapted accordingly to the filling state of the container.
[0017] [017] In the following, examples of embodiments of the vacuum system according to the invention will be described.
[0018] [018] In this description, negative pressure values are indicated in relation to the ambient pressure. In the literature, these negative pressure values are often also provided with a negative sign. This is currently waived, and only the amount of negative pressure is indicated. The negative pressure values, as is usual in the technical scenario, are indicated in units of mmHg, and for purposes of conversion to units S 1 a ratio of 1 mmHg = 133.322368421 Pa can be used. The term vacuum is used and in present description as a synonym for the term negative pressure.
[0019] [019] The inventor found that negative pressures of less than 60 mmHg and of more than 500 mmHg in practice are not necessary and the performance capacity of the vacuum pump when favorable to a construction of restricted performance capacity, for both lighter and preferably sustainable by the patient can be limited.
[0020] [020] As a vacuum pump in different embodiments, a volumetric pump is provided, such as a shut-off valve, a rotary distribution valve, a trochoid pump, a spiral pump, a piston pump, a helical pump, a lobe pump, a cylinder pump or a membrane pump.
[0021] [021] As the vacuum pumps provided for in the vacuum system according to the invention are to be understood within the scope of the present description also as a combination of at least two pumps or multistage pump systems. In one embodiment, the vacuum pump for example is equipped with two pump stages. In this case, the vacuum pump is preferably equipped with a combination of pumps. Preferably, the vacuum is generated through a preliminary vacuum with the help of a preliminary pump.
[0022] [022] An important parameter for the successful treatment of the vacuum system according to the invention is the evacuation time interval required to evacuate the volume in question respectively up to the necessary negative pressure in the parts to be treated of the cavity volumes . The maximum suction performance of the vacuum pump is so dimensioned in preferred embodiments that taking into account the dead volumes that are formed in practice in a short time of approximately half an hour, the preset pressure value is obtained -determined according to the invention of the vacuum.
[0023] [023] In other embodiments, the maximum possible evacuation time interval lasts up to a few seconds, especially a maximum of 2 seconds to achieve a defined continuous vacuum. Correspondingly, in the aforementioned embodiments of the vacuum system, the pressure regulation unit is built, to control the vacuum pump in operation until the vacuum is obtained within a value range of the evacuation time interval, which comprises the values minimum and maximum of the evacuation time interval. The negative pressure is kept constant according to the evacuation time interval.
[0024] [024] Advantageous embodiments of the vacuum system additionally feature a user input unit connected to the pressure regulation unit which is designed to accept a user input from the evacuation time interval and / or a negative pressure value and lead to the pressure regulating unit. The pressure regulation unit is designed to determine the control signal in question by calculating the current user input and forwarding it to the vacuum pump control input.
[0025] [025] In a variant it is also possible for exceptional situations to operate the vacuum system with an evacuation time interval greater than 5 seconds through the corresponding user input in the user input unit (or in a handpiece to be used) handled by the doctor or pedal, which is connected to the user input unit). This can also be convenient if, with a single pump system, both vacuum endoscopy at the time in focus and vacuum treatment of external wounds can be performed.
[0026] [026] A certain momentary increase in the vacuum in relation to the predicted value for therapy can be initially displayed, also at the beginning of therapy for a short period of time in order to ensure a secure fixation of a drainage at the treatment site. Also after placement, initially a higher negative pressure is temporarily advantageous so that the fluid collecting medium can be firmly attached by suction, for example not to accidentally move through an endoscope inserted in this initial phase in the body. In this case, however, this is possibly compared to the overall therapy time of an interval and a relatively short initial time of, for example, 15 minutes, while the duration of therapy can typically extend over several days.
[0027] [027] After successful placement, the patient will carry the vacuum system with him. Preferably the user input unit features a lockable mode switch, which allows an adjustment on the user side of a therapy mode or an endoscopy mode, the pressure regulating unit being designed to emit in therapy mode only the second or third control signal, but not the first control signal, and the pre-defined range of negative pressure values extends in therapy mode by negative pressure values in relation to an ambient pressure between a pressure minimum negative pressure of 60mmHg and a maximum negative pressure of 250mmHg. The locking of the mode switch is preferably possible only with a key, a key being also understood as a code.
[0028] [028] According to a knowledge of the inventor in the sense of improving the invention, the success of the therapy is further improved when the evacuation time interval and the negative pressure are adaptable correspondingly to an examination to be performed or therapy respectively. During the treatment of esophageal injuries, for example, the pathophysiological negative intrathoracic pressure and pressure oscillations are directed by the breathing movement against the suction effect of the vacuum pump. This physiological negative pressure needs to be elevated and act in the opposite direction through a very short evacuation time interval from the vacuum pump in the suction direction of the suction pump. Unlike for therapy in the esophagus in a treatment with negative pressure after insufficient anastomoses in the rectum with previous anus and only some secretion, a longer evacuation time interval within the limits according to the invention of up to 5 seconds can also be well bring good therapeutic results.
[0029] [029] If the vacuum is established up to the set pressure then that pressure will need to be kept constant. A drop in negative pressure is immediately registered by the vacuum system according to the invention with the help of the measuring probe and within the evacuation time interval, which can be eliminated again, since the residual vacuum still advantageously remains even a very long time. shorter than the evacuation time interval makes it necessary to reset the vacuum setpoint. In this sense, a constant negative pressure at the therapy site can be ensured. Preferably, the pressure regulating unit and the vacuum pump are therefore designed to be able to establish, according to detailed measurement signals with a frequency of at least 30 vacuum establishments / minute, the defined negative pressure. This is shown to be advantageous for endoscopic vacuum closure therapy in the upper gastrointestinal tract. In other embodiments with the vacuum system, up to 60, more preferably 120 vacuum settings / minute can be performed.
[0030] [030] In a preferred embodiment, the evacuation time interval can also be adjusted using the pressure regulating unit. For this purpose, the vacuum system additionally features a user input unit connected to the pressure regulating unit which is designed to accept a user input from the evacuation time interval and forward to the pressure regulating unit. The pressure regulation unit is designed to activate the vacuum pump according to the user input, to generate the negative pressure in the predetermined evacuation time interval.
[0031] a) um tempo de evacuação de no máximo 2 segundos; b) um tempo de evacuação aproximadamente definível por outra entrada de usuário entre 0,5 e 5 segundos; c) um tempo de evacuação ajustável de 2-5 segundos. [031] The pressure regulation unit is designed in another embodiment, to support a choice between the following pre-defined therapy settings via the user input unit based on corresponding pre-defined control parameters : a) an evacuation time of a maximum of 2 seconds; b) an evacuation time approximately definable by another user input between 0.5 and 5 seconds; c) an adjustable evacuation time of 2-5 seconds.
[0032] [032] For example, it is advantageous for the treatment of a leak in the esophagus to have a negative pressure between 80 and 150 mmHg (10665 and 20000 Pa) and the selection of a maximum evacuation time of 2 seconds.
[0033] [033] The value of the negative pressure to be chosen is in many cases of application also dependent on a contact surface of a fluid collecting medium with the surrounding tissue. In the case of a large contact surface for fixing the fluid collecting medium compared to a smaller contact surface, a small negative pressure may be required.
[0034] [034] The user input unit, for this reason, is preferably designed additionally to receive additional input from an identification of a type of a fluid collecting element. The pressure regulation unit is designed in this embodiment, to determine, based on previously stored therapy data, values assigned to the indicated type of the vacuum fluid collecting element and / or the evacuation time interval and to activate the vacuum pump. in the operation corresponding to these calculated values.
[0035] [035] In the clinical application, a permanent permanent negative pressure was initially successful. A variant, however, foresees that the pressure regulation unit is designed to drive the vacuum pump, to apply in a variable way the undulating negative pressure between at least two negative pressure values, for example, between approximately 100 mmHg and approximately 150 mmHg. Through an application of oscillating negative pressure the granulation stimulus can be increased over the wound. However, at no time can a suction interruption lasting more than a few seconds occur.
[0036] [036] The pressure regulating unit is designed to monitor negative pressure values during an application of negative pressure and an examination performed under negative pressure. Measuring probes can be connected either in electrical communication, or connected by wire, or by wireless communication with the pressure regulating unit of the vacuum system so that negative pressure values to be generated can be controlled and adjusted previously adjusted of the vacuum pump through the pressure regulation unit. In this way, based on the pressure capture through the measuring probe, a control and command of the pump suction can be carried out directly on a fluid collecting element. In this way, a stoppage of therapy is prevented, for example, in the event of a clogging of the fluid collecting medium or the fluid communication element. This is especially important in the treatment of esophageal lesions, as otherwise an inflammation of the rib cage can occur, which can lead to a lengthy treatment and can often lead to death.
[0037] [037] Preferably the pressure regulating unit, through the analysis of the measurement signals present from the pressure sensors against a respective setpoint, also records the actual evacuation time required.
[0038] [038] The vacuum system is preferably equipped with a vacuum drainage arrangement that is connected upstream to the vacuum pump on the negative pressure side. In the case of the same suction performance of the vacuum pump, rapid suction is possible with a smaller secretion collection container than in the case of a larger container. The pressure regulating unit, for this reason, is preferably designed to receive a user input of a volume from the collection vessel through the user input unit and to adjust the pump performance as an additional function of the input volume. In this case, the pressure regulation unit controls the pump performance not only as already clarified according to the evacuation time desired by the user, but also considers the volume of the secretion collection container.
[0039] [039] The pressure regulation unit is designed to take into account a volume of the secretion collecting container as part of the dead volume. Depending on the application, different volumes may be required for the secretion collection container so that the pressure regulation unit must use different values of the dead volume. These can be stored, for example, in a pressure regulator memory and selected via user input. In order to avoid entry failures, an encoding placed next to the secretion collection container and readable by the pressure regulation unit can alternatively be registered, from which the value in question of the dead volume is derivable. In the case of a small volume of the collecting container, the suction performance of the pump is adjusted lower, in the case of a larger volume, the suction performance is adjusted correspondingly upwards.
[0040] [040] The secretion collection container is designed to accommodate and / or divert, during operation, accumulated secretion and gas, which is aspirated by the vacuum pump. Preferably, the pump is additionally equipped with a previous secretion-collecting container, stable at negative pressure, which is connected upstream in the direction of suction from the application site on the patient to the vacuum pump and the secretion collecting container and is connected to the secretion collecting container. with fluid conduction. The pressure regulating unit is correspondingly designed to include a volume of the secretion collecting container as another part of the dead volume.
[0041] [041] The collected secretion can in this variant be sent out of the previous secretion collecting container to the secretion collecting container. Preferably, the previous secretion collecting container and the secretion collecting container can be connected to each other via a valve. In addition or alternatively to the valve, the previous secretion collection vessel and the secretion collecting vessel can be connected to each other through an interchangeable filter. Preferably, this collection vessel and its connection to the vacuum can be configured interchangeably.
[0042] [042] These embodiments provide for suction through the dead volume of the secretion collecting container. When the suction of the vacuum pump is done through a secretion collection container, basically its dead volume together with the suction performance of the pump (1 / min.) Determines the suction speed. The suction performance of the vacuum pump for this reason is preferably dimensioned, to also evacuate the dead volume, which is formed by the secretion collecting container and previous secretion collecting container, within the evacuation time interval.
[0043] [043] The secretion collecting container can be connected via preferably fluid communication elements stable to negative pressure, especially drain hoses, with a fluid collecting element so that negative pressure can be established next to the fluid collecting element through the secretion collection container. The pressure regulating unit is designed to include an additional volume that has at least one fluid communication element stable to negative pressure, especially a drain hose which, by being distally connected to a fluid collecting element and proximal to the secretion collecting container or to the previous secretion collecting container as another part of the dead volume. In the case of constant evacuation volumes in fluid communication elements, fluid collecting element and secretion collecting container in one embodiment, the evacuation time must be regulated through the pressure regulating unit by regulating the suction performance of the vacuum pump. In this case, the vacuum pump pressure regulation unit receives in addition to the user input as another input for regulation via the measuring signal input, measured values from a negative pressure measuring probe, which is placed in the volume cavity to be evacuated. Next, details of the construction and placement of the measuring probe will be explained.
[0044] [044] If a previous secretion collecting container is used, it will preferably be connected to the vacuum pump in such embodiments so that it can be activated with a preliminary vacuum. In the case of this embodiment, the vacuum pump has two stages and is designed to generate negative pressure at the point of examination / treatment with the help of a first of the two pump stages through a preliminary vacuum in the previous secretion collection vessel. This presents comparatively the smaller volume of the two collecting containers to obtain the shortest possible evacuation time. The previous secretion collection container typically has a volume of 50 to 300 ml. The secretion collecting container, on the other hand, typically has a volume of 100 ml to 1000 ml. However, smaller or larger volumes can also be selected, with adaptation to the required suction performance of the vacuum pump.
[0045] [045] Another preferred embodiment provides for a pressure regulating unit, which adapts the pump's performance capacity not only according to the volume of the secretion collecting container, but also additionally considers a volume of a fluid collecting element to be evacuated. In this case too, as already described above, an additional user input is provided through the user input unit, which is sent to the pressure regulation unit, which in turn controls the pump performance to obtain the required evacuation time interval. . In this case, within the evacuation time interval, an evacuation of the secretion collecting container is carried out at the same time.
[0046] [046] Preferably, the performance capacity of the pump is dimensioned in such a way that within the evacuation time interval the dead volume of the secretion collection container and the fluid collecting element is evacuated. Experience so far shows that a controllable pump performance in the range of 1l / min. at 20l / min. it is necessary.
[0047] [047] The pressure regulating unit, in a form of embodiment of the vacuum system, is equipped with a monitoring unit that automatically monitors if the negative pressure has fallen below the reference value or has been exceeded, the duration of the time interval of evacuation, as well as a negative pressure unit period and in case of exceeding the predetermined limit values it regulates the pump performance. In this way, during operation with a drop in the negative pressure, for example through an insufflation of the examination gas, the vacuum can be quickly restored and consequently maintained continuously.
[0048] [048] Preferably, in addition to the control signal input, other switching and regulation elements are provided in the vacuum pump through which a vacuum pump operation can be carried out. In particular, the pressure regulating unit and the user input unit can be integrated with the vacuum pump as a construction unit.
[0049] [049] To record monitor the set pressure and the evacuation time interval, at least one negative pressure measurement probe is provided in the vacuum pump and / or at least one connection for an external negative pressure measurement probe. The negative pressure measurement probe is directly or indirectly connected to a fluid collecting medium connected to the vacuum pump and / or to a fluid communication element, and designed to send your measurement results as measurement signals to the regulation unit pressure of the vacuum pump. This is preferably the case for the fluid communication elements of drain hoses.
[0050] [050] With the vacuum pump, a vacuum can be established with one or more fluid collecting elements. In the case of several fluid fluid elements, the vacuum pump is preferably designed to generate a respective vacuum generation that is totally independent of each other. In this case, a plurality of corresponding connections and drainage units are provided. In addition, the pump performance is also that of the vacuum pump and is also adapted to the high demands of simultaneous generation of negative pressure in different fluid collecting elements. The pressure regulation unit is designed to send control signals to individually controllable throttling elements, which are arranged in the respective branch to produce the individually adapted establishment of a respective vacuum.
[0051] [051] Especially, the vacuum pump is suitable for the generation of vacuum in the case of intracavitary and intraluminal endoscopic vacuum therapy. However, it can also be used in vacuum closure therapy on external wounds. It can also be used in vacuum endoscopy.
[0052] [052] The vacuum system is preferably built as a chargeable unit so that the patient can move as freely as possible. The electric power supply of the pump occurs in the portable version, for example via battery or accumulator.
[0053] [053] Note that in an alternative embodiment in treatment rooms the vacuum pump can be present in the form of an integrated, centrally controlled vacuum wall suction element, which can be adapted in its performance as a pump. corresponding way to provide at least the necessary vacuum according to the invention in the required evacuation time interval according to the invention. Thus, in the corresponding infrastructure in a treatment compartment, the generation of the necessary vacuum can also occur without a separate vacuum pump, and the correspondingly designed side suction also replaces the vacuum pump. The pressure regulating unit of the vacuum system according to the invention needs to be adapted in such an infrastructure to be able to control vacuum pressure control elements, for example choke elements, according to the indicated pump performance (in most cases not influenced) of lateral suction as a function of time so that the necessary negative pressures between the fluid collecting element and lateral suction are maintained in the predetermined time interval. Through the connecting element, filtering, switching and valve, the conduction of a vacuum to a fluid communication element is possible and the operation is carried out through the endoscope handle.
[0054] [054] Advantageously, the user input unit of the vacuum system comprises a device for manual control of the vacuum pump, through which a start signal to start and a control signal to weaken the vacuum next to the collector element fluid for routing to the pressure regulating unit can be generated and emitted. Preferably, the user input unit is connected to one or more switching devices on the endoscope handle alternatively operation of the pump is also possible via the foot / hand switch or directly on the pump.
[0055] [055] In order to be able to carry out the research, especially a vacuum endoscopy comfortably, it is necessary to establish and let off short distances during the examination cycle at negative pressure. For this purpose, in preferred embodiments, a switching unit on the endoscope or a foot control switch is provided.
[0056] [056] The vacuum system has in its embodiment a plurality of connections on the negative pressure side for one or more drain hoses. The pressure regulating unit is designed in this embodiment to operate at a corresponding user input via the user input unit, the vacuum pump, optionally aspirating or washing on one side only on one of the connections or alternately on two of the connections connections or at the same time on two connections. In this way, the vacuum can be controlled simultaneously and independently between its various fluid collecting elements, which will be further explained in detail in the scope of the description of figures.
[0057] - um tal sistema de vácuo de acordo coma invenção ou um de seus exemplos de concretização descritos no âmbito desse pedido de patente, - uma unidade de overtube que é conectada no lado de pressão negativa à bomba a vácuo do sistema de vácuo através de pelo menos um elemento de comunicação de fluido e porta um elemento coletor de fluido, - um endoscópio, que pode ser introduzido na unidade de Overtube e ser deslocado em uma direção de proximal para distal ou vice-versa e - uma sonda de medição de pressão negativa, que é conectada à unidade de regulação de pressão do sistema de vácuo. [057] The vacuum system according to the invention forms in preferred embodiments a technical component of an endoscopy arrangement according to the invention with - such a vacuum system according to the invention or one of its exemplary embodiments described in the context of that patent application, - an overtube unit which is connected on the negative pressure side to the vacuum pump of the vacuum system via at least one fluid communication element and carries a fluid collecting element, - an endoscope, which can be inserted into the Overtube unit and moved in a direction from proximal to distal or vice versa, and - a negative pressure measuring probe, which is connected to the pressure regulating unit of the vacuum system.
[0058] [058] Preferably the endoscope is also connected to the vacuum pump of the vacuum system via a fluid communication element and carries another fluid collecting element.
[0059] [059] This example of embodiment according to the invention in the form of an endoscopy arrangement serves as a basis for the knowledge that in the case of double balloon endoscopy known in the prior art a sufficient fixation of an endoscope or Overtube by fixing the balloon in the intestinal wall it is often not possible and therefore, deeper exams are not feasible. The balloon may be slightly off-center, especially not enough fixation for intestinal Lorena (stomach / colon. When the balloon is overfilled, there is a risk of damage to the intestinal wall, which may cause rupture of the intestinal wall.
[0060] [060] The endoscopy array uses this knowledge to form an endoscopy array for endoscopic intraluminal vacuum closure therapy, to place by endoscope one or more fluid-collecting elements, for example sponge drains, for example intraluminal in the intestinal lumen and anchoring with a vacuum according to the predetermined parameters according to the invention at the place of placement. The sponge drains adhere by suction in this example with the vacuum applied to the sponge in the intestinal mucosa and are fixed by negative pressure at the placement site.
[0061] [061] Through an alternating opposite displacement of an Overtube in relation to an endoscope inserted in it, it is possible to advance the endoscope in the intestine. Endoscope and Overtube in this case need an anchorage in relation to the adjacent tissue, for example intestinal mucosa. This anchoring is done in the example of the present embodiment of the endoscopy arrangement by sponge drainage adherence to the intestinal mucosa. For this reason, the form of treatment or examination thus based is also referred to as vacuum endoscopy.
[0062] [062] Endoscopic vacuum therapy is used to treat internal wounds. Its effectiveness could first be proven in the case of poor suture seals in the rectum, then in intestinal leaks from another location such as esophagus, stomach, small intestine and large intestine. In the case of internal wounds, located below the surface of the skin, cavities, abscesses, cavities, abscesses, empyemas, fistulas, which are accessible or become accessible through an out-hole through an endoscope, endoscopic vacuum therapy can also be used for wound treatment. In the case of endoscopic vacuum therapy, natural and artificial access routes to hollow organs, gastro-intestinal tract and body cavities are used endoscopically. Sponge drains are placed with the help of the endoscope internally, intracorporeally, intraluminally and intracavitaryly. In the case of the intraluminal therapy variant, the sponge body is placed in an intestinal lumen at the time of the defect. In the case of the intracavitary variant, the sponge body is inserted by the defect into a wound cavity (extraluminal). Both therapies can also be combined. After the sponge body is positioned on the transferred drain hose, a vacuum suction is applied. The wound cavity or intestinal lumen collapses under suction along with the elastic sponge body. The sponge surface adheres by suction to the surface of the suction-type wound at the same time it is fixed through suction at the placement site. Effective drainage of the wound occurs, at the same time the wound defect is closed. Under the action of the permanent drain on the wound surface and the application of vacuum the wound is cleaned, granulation tissue is formed and the wound closes accordingly. At the interval of several days, an endoscopic exchange of the sponge drain is performed.
[0063] [063] A probe form of endoscopic vacuum closure therapy does not achieve complete cavity closure, as illustrated above, but a maximum secretion output. In this case too, the sponge drain is placed in an organ, for example, duodenum (post-pyloric vacuoduodenal outlet) and thus dosed under suction. The drainage action is dosed in such a way that complete closure of the intestine does not occur, but the fluid collecting medium remains under suction in order to obtain an ideal fluid conduction (in the example of a duodenal placement of secretions from the pancreas and bile coming out) intestinal lumen). It is possible to use this type of application also in other organs or cavities where a maximum secretion output is desired.
[0064] [064] Through the invention, for example, a permanent complete emptying of the stomach is obtained. Through the invention, numerous innovative therapy possibilities are obtained for internal wound therapy.
[0065] [065] The following describes improvements to the endoscopy arrangement.
[0066] [066] The vacuum pump is preferably connected via one or more fluid communication elements in the form of drain hoses and / or in the form of a channel in the endoscope which can also be arranged at least partially in or next to the unit drain by sponge, to the drain unit by sponge. Especially preferred is the fluid communication element through holes in a fluid-conducting wall to the fluid collecting element. These drilling holes are particularly advantageously located in a segment between the proximal or distal end of the hose. The drilling holes are located in the central segment of the fluid communication element. The drilling holes are arranged in an embodiment in several segments between the proximal and distal end of the hose. The drilling holes preferably have a diameter of 1 mm to 10 mm. Through the drilling holes in the hose wall it is possible from the outside by bonding, suturing or other fixation possibility to fix the fluid collecting medium.
[0067] [067] Such fluid communication elements are equipped with double lumen or even multiple channel enhancements. Such a fluid communication element is suitable for washing and aspirating through different channels. At least one of the channels is configured so preferably in its diameter that a negative pressure measurement probe can also be inserted into the fluid communication element temporarily or permanently.
[0068] [068] Especially advantageously one half of the fluid communication element can be thin lumen and the other half thick lumen. This can be advantageous if the drain is placed in such a way that, for example, in the presence of an esophagocutaneous fistula, one side of the drain is percutaneously deflected over the cutaneous fistula going outward and the other side of the drain is deflected inward over the esophagus for oral use. The deviated sides of the fluid communication element can be closed with clamps. Through the fluid communication element, a washing treatment can be carried out mainly. Especially, in the placement of the fluid collecting element and in the central segment and diversion of both sides of fluid communication, one side can be used to suck and the other to wash.
[0069] [069] The different diameters of the fluid communication element pass advantageously continuously in a conical shape and without graduation from the diameter of the thin lumen to that of the thick lumen. In this way, a non-traumatic placement of the drain is ensured. The drilling holes are located especially at the distal end of the hose.
[0070] [070] To facilitate the introduction of the sponge system, a wire-shaped guide element can be inserted into the fluid communication element.
[0071] [071] Advantageously, the fluid collecting and fluid communication elements are radio-opaque.
[0072] [072] Preferably, the fluid communication elements have an internal diameter of 1 mm to 10 mm. Preferably the fluid collecting element is in a cylindrical shape with an outside diameter of 5 mm to 30 mm.
[0073] [073] Larger diameters of the fluid collecting element can be used, for example, advantageously if an intestinal lumen is closed with a large internal diameter (such as, for example, in the stomach or large intestine). Smaller diameters of the fluid collecting element and the fluid communication element can be advantageously employed, for example, if thin lumen fistula routes are closed and drained.
[0074] [074] The outside diameter of the fluid communication element and the fluid collecting element are adapted in an embodiment to the internal diameter of an internal working channel of the endoscope so that they are displaceable within the internal working channel and can placement over the internal working channel of the endoscope. In this way, the placement of the drain under visualization through small holes is especially achieved. In addition, by minimizing the diameter, it is possible that with the help of endoscopic techniques, the number of regions can be increased, which can be obtained via endoscopy and, therefore, can be provided with a vacuum drainage unit.
[0075] [075] In an alternative variant, the external diameters of the fluid communication element and the fluid collecting element are adapted to the internal diameter of an external working channel of the endoscope so that they can be replaced within the external working channel and its placement can be performed on the external working channel of the endoscope.
[0076] [076] In the Overtube in a preferred embodiment, one or more drainage channels are integrated as fluid communication media. They are cylindrical. These drainage channels are stable at negative pressure so that they do not collapse under the applied vacuum. They can be connected via drain hoses stable to negative pressure with the vacuum pump. Especially the drainage channels present at its distal end in its wall one or more holes that drill in a way to conduct fluid, the Overtube out so that liquids and gases can be deflected by suction. At the height of the holes in the drainage elements, the fluid collecting element can be fixed or is fixed, for example, by gluing, by means of wires or tightening.
[0077] [077] The fluid collecting element connected in order to conduct fluid to the fluid communication element can be placed either endoscopically, by laparoscopy, thoracoscopy, often by intraluminal, intracavitary, intracorporeal surgery. The sponge drainage unit is attached to an example embodiment at the distal end of the endoscope and / or at the distal end of the Overtube unit. For the placement of sponge drains in deeper body regions such as, for example, large intestine, esophagus or duodenum with partially curved access routes, a drain hose is proposed at the end of which the sponge drain unit is sewn in the form of a polyurethane sponge body. Preferably, the sponge drainage unit has a hollow circular or cylindrical base body, also tubular in shape. It consists, for example, of a compressible elastic polyurethane sponge body with open pores. A pore size in the polyurethane sponge body of 200 μm to 1000 μm is preferred, especially preferably it is a pore size of 400 μm to 600 μm. The sponge can be adapted to the requirements by cutting out length and volume.
[0078] [078] In a preferred embodiment, the fluid collecting medium has an open pore film. Alternatively, a polyurethane sponge body can be coated with such an open pore film. The film can be stretched, for example, after adapting a measurement of the length of the sponge, which typically happens by cutting over the sponge. For this purpose, the open pore film is preferably configured as small bags and can be sewn with a thread. The film may have a structure made of two sheets of film, which are joined in order to conduct fluid over its entire surface through pores.
[0079] [079] The length and thickness of the fluid collecting element can be configured in a variable way as already mentioned. For example, the fluid collecting element is located in different embodiments between 2 and 10 cm in length, but other lengths are also possible depending on the field of application, as shown below. In other embodiments, the fluid collecting element has an external diameter of 1.5 to 3.0 cm. In this case too, adaptations outside this range of values may be convenient for certain applications. For intracavitary therapy, for example, the fluid collecting element is preferably 0.5 to 1.5 cm in diameter and 1 to 4 cm in length. For intraluminal therapy, on the other hand, the fluid collecting element is preferably 1.5 to 2.5 cm in diameter and 4 to 10 cm in length.
[0080] [080] Preferably the central channel has a diameter of 0.5 to 1.0 cm in the fluid collecting element, but depending on the application case, other diameters are possible.
[0081] [081] The sponge body can be grabbed or inserted under orthoscopic endoscopic conduction. Placement, however, can be technically difficult. Visibility conditions are limited. The internal wound holes, through which, for example, during intracavitary therapy the sponge body is introduced, are often small, angled and difficult to access. Mobility is limited by sponge drainage. The spaces to be submitted to endoscopy are narrow. A truncated sponge drain easily hooks into the internal wound or intestinal mucosa. For this reason, the drain hose ends preferably in the distal direction with a tip.
[0082] [082] The tip of the drain is especially advantageously tapered as well as especially soft and configured to be non-traumatic in order to avoid injury to adjacent tissue. The distal end that ends at the tip of the drain hose can extend over the distal end of the fluid collecting element it can also end in the sponge body.
[0083] [083] A conical confluent configuration of the end of the hose is advantageously continued in a sponge body seated so that the sponge body is directly in contact with the drain. In this way, the drain placement maneuver is facilitated.
[0084] [084] The conical projectile tip of the drain hose is also provided in a form of a central channel so that the conductive wire can be placed.
[0085] [085] The tip can advantageously also be equipped with a channel that passes transversely, through which, for example, a wire can be placed. At the distal end of the drain hose, on the fluid collecting element or on the fluid collecting element, a device is advantageously attached which can be caught with tweezers, hooks, loops or other deposition instruments. In particular, a loop of wire or wire can be attached. Especially a grip ball made of metal or plastic material can be attached. Alternatively, metal or plastic eyelets can be attached. Or a wire can be attached. The yarn can have a length, for example, from 1 cm to 250 cm.
[0086] [086] If there is still an additional external access to the internal wound (for example, in the form of a fistula) the wire can be removed from the inside out by the endoscopic technique over the fistula. In the event of a loss of the tips during the laying maneuver, the wire can be used for recovery. If there is an additional connection to the outside, the placement can be done with a placement instrument or wire fixed also with the traction technique (passage). Alternating maneuvers can be greatly simplified with the use of the passing technique.
[0087] [087] The device that can be picked up by forceps, hook, loop or other placement instrument, is specially designed to be resistant to traction so that the drain can be pulled into it through the tissue, intestinal luminal, fistulas. The device must be designed in a flexible and non-traumatic manner.
[0088] [088] The insertion tip must be specially designed so that after placement on the end of the drain hose the outer side of the hose ends flush with the outer side of the insertion tip.
[0089] [089] If there is no fistula for the outward wound, through a puncture, an additional outward connection can be created through which the thread can be executed. The wire can also be used for endoscopic, laparoscopic, totacoscopic or open surgery unification maneuvers. The intraoperative placement maneuver can be facilitated considerably in this way.
[0090] [090] For example, the passage technique can be used during the placement of a drain by sponge in the esophagus, if a percutaneous endoscopic gastrotomy has been implemented. Through this percutaneous access route to the stomach, a wire can be introduced and exposed with a gastroscope through the mouth. The wire is connected with the tip of the sponge drain and then stretched by traction on the wire at the place of placement in the esophagus. In this way, bulky and longer sponge bodies can be placed in an atraumatic way. Intraluminal placement is greatly simplified.
[0091] [091] The wire is preferably attached to the sponge body or the drain hose in such a way that it can be removed at any time. This is possible, for example, when the wire is conducted as a double wire or endless loop through a wire loop or eye that is attached to the end of the drain hose or sponge body. If the wire is removed, the endless loop will be detached and pulled.
[0092] [092] Preferably a longitudinal axis of the sponge drain unit passes basically parallel to the longtube of the Overtube.
[0093] [093] Preferably, a channel formed in the sponge drain unit (that is, the fluid collecting element) bypasses the entire perimeter of the Overtube, with the drain hose inserted in the sponge drain unit having holes therein. side. The fluid collecting element, however, can alternatively also only partially circumvent the Overtube.
[0094] [094] The fluid-collecting element is advantageously provided with an external fluid-conducting layer that facilitates the slide in relation to the intestinal mucosa in the absence of negative pressure. Advantageously, this outer layer is a fluid-conducting film. In the case of vacuum endoscopy, the film layer is advantageously hydrophilic so that the fluid collecting element can slide more easily over the mucosa. However, it must be observed carefully so that the outer layer can lead the suction to be exerted incessantly with fluid conduction mainly with a larger area possible for the intestinal mucosa so that the fluid collecting element is adhered by suction and fixed.
[0095] [095] The suction action of endoscopic vacuum therapy can evolve on the wound surface only with open pores of the sponge in the inner section of the sponge drain unit. When the pores are clogged, for example, by mucus, saliva or rigid secretion, the suction action may not evolve in the wound. Especially in the case of esophageal intraluminal therapy, the sponge body may clog partially or totally by swallowed viscous saliva. In the case of partial clogging, the sponge body does not adhere by suction to the entire surface, but only partially with the pores open in the fabric. When pores clog by secretion, the sponge may not adhere to these points. We can observe that between the clogged sponge surface and the esophageal mucosa, saliva and secretion can be emptied into the stomach while in this case simultaneously the sponge body with the pores still open is adhered to the mucosa.
[0096] [096] The hermetic restriction for establishing a vacuum on the one hand lies in contact with the aspirated tissue surface, on the other hand in closing the surface through clogging saliva or viscous secretion. Under these conditions, effective vacuum suction on the circumscribed mucosa or wound surface may last. If the pores of the sponge body are totally clogged by viscous secretion, the suction action may not evolve at the base of the wound, the vacuum will then be present only in the fluid-conducting system. There will be a paralysis of the therapy or even a worsening of the wound situation.
[0097] [097] A form of embodiment of the endoscopy arrangement therefore provides for the sponge body to have cavities of a probe on its outer surface that can be placed during the operation of the endoscopy arrangement between the intestinal wall and the sponge body. An additional probe of this type can be used for enteral feeding, emptying the stomach or washing. A vacuum can be applied close to the sponge body in the case of a probe simultaneously contained. At those points, where the additional probe is between the sponge and the intestinal wall, the sponge does not develop a direct suction action on the intestinal wall. In this case, the typical changes in the mucosa or wound conditioned by suction and the sponge cannot be observed either. In the case of direct sponge contact on the mucosa, the mucosa molds to the sponge surface in such a way that the mucosa adheres to the pores of the sponge in the form of a protuberance.
[0098] [098] The fluid collecting element is provided in another embodiment by segments of a surface closure for closing the open pores. The surface closure can be carried out using an elastic adhesive substance that can be applied in liquid form or as a spray on the surface of the sponge and in this case it hardens elastically.
[0099] [099] Thus, it is possible that the closed surface of the sponge does not make the suction action on the mucosa contained here or on the wound surface. The sponge body adheres only with the surface of its pores open on the tissue surface. By closing, an effective local vacuum can also be established. In the case of correspondingly selective placement of the sponge body, it is possible that vacuum suction and suction adhesion of the sponge body can be carried out only in the circumscribed tissue area. In this way, a possible injury can be avoided by vacuum suction on the tissue, it does not need to be treated. At the same time, local vacuum suction can be applied to the location that needs to be treated.
[0100] [0100] In the case of a cylindrical sponge body, which must be placed in an esophagus, the closure can advantageously be carried out on one third or half of the surface over the entire length of the sponge body. Depending on the sponge body configuration, different models for surface closure are possible. During the placement of a partially closed sponge body, it is possible that saliva, secretion, liquids between the closed sponge surface and the mucosa contained not exposed to vacuum suction are physiologically removed along the esophagus to the stomach. Saliva retention is reduced, enabling liquid feeding. During the closing, a feeding probe can also be placed for enteral feeding.
[0101] [0101] The surface closure can be performed alternatively with elastic films glued on the sponge. Advantageously, these films are profiled in a longitudinal direction so that the secretion can better empty along the films by the capillary action in the distal direction. The surface closure can also be carried out with elastic tubes adhered in the longitudinal direction that are fixed with the convex side on the sponge body by gluing. With the mucosa contained on the concave side, a tubular-shaped tunnel is formed through which secretion can be removed without being sucked into the sponge body. The different types of surface closure referred to can be combined with each other.
[0102] [0102] In addition, in one embodiment for conducting secretions, at least one tubular-shaped tube is integrated into the sponge body. In this way, a secretion flow (for example, saliva flow to the stomach) is made possible through the sponge body under vacuum suction. Premature clogging of the sponge pores by viscous secretion is reduced or delayed so that the vacuum can develop its action at the base of the wound or mucosa better and in the long run. At the same time, in the treatment of the esophagus, saliva retention can be reduced and enteral feeding made possible in the case of intraluminal vacuum therapy. Through this form of implementation, numerous new therapy possibilities are obtained.
[0103] [0103] The fluid collecting element should be especially advantageously equipped with another complete channel in the longitudinal direction. Through this channel, another probe can be inserted. It is particularly advantageous to introduce a tubular tube that runs through the collector element along its entire length and extends outwards to the ends. The tube in another embodiment has the same length as the fluid collecting element, typically a sponge body. It is not connected in a fluid conductive way to the sponge body. It can be provided at both the proximal and distal ends of a tulip-shaped widening. The tube does not collapse, when the vacuum is applied, it is also stable at negative pressure. The tube can be folded without breaking. The tube serves as a fluid-conducting element for viscous secretions such as saliva or feces. When these secretions are conducted through the sponge body located below the vacuum suction, this avoids clogging the sponge pores and at the same time the vacuum exercise can be maintained at the base of the wound. In the fluid conducting element, probes, endoscopic instruments, a guide wire or an insertion and insertion thread can also be inserted. In particular, an endoscope can also be introduced. In particular, an endoscope can also be used as a conducting element for the insertion of a vacuum system with a fluid conducting element. The fact that the endoscope itself can be used as a guide rail for sponge drainage greatly facilitates the maneuver, complete endoscopic control and visualization is achieved and work steps can be reduced in the case of placing the fluid collecting element. The endoscope does not need to be removed from the body. The endoscope preferably has a diameter between 5 and 10 mm.
[0104] [0104] It was especially advantageous that in this type of construction the seal when applied to the esophagus is successful for a completely circular aspiration, especially intimate over the entire length of the sponge and therefore a very good and safe coverage of a sponge is possible. defect in the esophagus with drainage at the same time effective at the base of the wound. Advantageously, a physiologically oral enteral feeding with this embodiment is possible at the same time. These are clear advantages in relation to the single stent placement procedure, performed in the state of the art with self-expanding stents that, through the outward expansion force, should obtain a defect coverage.
[0105] [0105] The tube can be fixed by means of suture, glue or other type of medium in the sponge body. However, no special fixation of the tube is necessary inside the channel of the fluid collecting medium. On the other hand, when no fixing is carried out, this is especially advantageous. When in the case of a removal maneuver the tube can be removed easily regardless of the sponge body. This is especially advantageous if the sponge body is firmly attached to the intestinal wall and released from the wall mechanically with an endoscope. In the applied suction the tube is fixed by vacuum suction in the sponge body.
[0106] [0106] For the placement of a vacuum drainage system equipped with such a fluid-conducting element (ie the sponge drain unit, if necessary with Overtube,) a booster can be used. The booster has a tube, into which an installation and placement bar can also be inserted or an endoscope. The pusher can be moved slidingly over these conductive elements. With the booster, a vacuum drainage system can be moved in the distal direction and, therefore, be separated at the place where the conductive element is placed. Advantageously the booster is provided like the vacuum drainage system of a longitudinal groove so that they can be placed laterally at any time of the examination on an endoscope or removed.
[0107] [0107] Advantageously, the distal and proximal ends of the fluid-conducting element are radially divided and are movable outwardly in relation to a part of the central tube of the fluid-conducting element in the form of a hinge or wing. When moving over the conductive element with the booster, all segments of the fluid conducting element are in contact with it. When vacuum suction is applied to the sponge body, the sponge body collapses, shrinks and adheres to the intestinal wall. At the same time, the moving ends of the fluid collecting element separate and open in a tulip shape. The vacuum drain also anchors for aspiration at the placement site in the proximal and distal directions. Through the tulip-shaped enlargement, saliva and / or secretion can be collected more easily into the fluid-conducting element and conducted through the fluid-collecting element without being sucked. Especially advantageously, this embodiment can be used to conduct physiologically accumulated secretion such as (depending on the type of application) saliva, small intestine feces or large intestine feces or air. Advantageously in relation to a complete closure of the intestinal lumen through vacuum therapy with this embodiment, in the case of an esophageal treatment, for vacuum therapy, physiologically oral enteral feeding and / or insertion of feeding tubes is possible. or stomach emptying. In the case of treatment in the large intestine, it is possible to empty the stool and prevent the placement of an artificial intestinal outlet.
[0108] [0108] The ends of the fluid-conducting element may also consist of an elastic film or other surface closure.
[0109] [0109] Alternatively to the use of the tube, a channel placed in the sponge body with a surface closure can be provided. Advantageously, this internal surface closure is made of a longitudinally profiled film along which the secretion is drained through the capillary action and thus preventing the sponge body from clogging in contact with the intestinal wall. Advantageously, the surface closure extends to the proximal and distal end of the sponge body.
[0110] [0110] Overtube forms in a form of embodiment a foldable plastic bushing, adapted to the longitudinal extension of the endoscope in the direction from proximal to distal (hereinafter longitudinal direction), into which the endoscope can be inserted. The length can be selected for vacuum endoscopy advantageously in such a way that the Overtube is ca. 20-80 cm shorter than the endoscope. Through this difference in length, both can be moved in the longitudinal direction to and fro between them. The Overtube can be built with different lengths and different diameters. It is also advantageously constructed with a material that allows it to adapt its length, for example, through cutouts at the proximal and / or distal end individually to the length of the endoscope. Preferably the Overtube has a length between 80 and 160 cm. Therefore, other lengths are also possible.
[0111] [0111] The diameter of the Overtube is preferably just a little larger than the outer diameter of the endoscope, so that both can easily be moved between themselves and the total diameter is not very large. Preferably, the internal diameter is 8 mm to 15 mm. However, other internal diameters are possible. Preferably, the outside diameter is 10 to 25 mm, but other outside diameters are also possible.
[0112] [0112] For better sliding, a sliding means can be inserted. Preferably the outer cover of the endoscope, the inner side and the outer side of the Overtube is coated with a material that is also especially hydrophilic, sliding. Advantageously, Overtube has a funnel-shaped enlargement at the proximal end so that an endoscope can be inserted more easily. Advantageously, at the proximal end of the Overtube, a valve-type closure is provided through which the introduction of an endoscope is possible, an escape of examination gas or secretions is prevented. Advantageously, at the distal end, the lumen tapers so that it is in contact with the endoscope and thus avoids the formation of steps that would hinder the advancement of the entire unit or the sliding is facilitated in relation to the endoscope.
[0113] [0113] In an embodiment in a directly proximal and distal direction of the fluid collecting element, a lip-type thickening of an annular shape so that in the case of a suction establishment it forms proximally and distally from the sponge next to the union by the lip in relation to the intestinal wall a more intimate union and therefore a better seal that facilitates the establishment of a vacuum in the sponge. Preferably protrusions of the annular type are made elastically. Preferably, the projections are also grooved like the Overtube.
[0114] [0114] One embodiment of the sponge drain features a support bushing. It is constructed in such a way that it can be placed over the Overtube and / or over the endoscope and removed again. It is specially built in such a way that it conducts fluid to connect the drain hose that passes the Overtube and / or endoscope and the fluid collecting element, that is, the sponge of the sponge drain. Preferably the support bushing together with the fluid collecting element can be fixed with a glue, adhesive strips, elastic tape, wire or another possibility of fixation through the suction holes on the Overtube / endoscope or it is fixed in its production already correspondingly. The use of the Overtubes / Endoscope, however it is possible according to the application optionally with or without a fluid collecting element.
[0115] [0115] The Overtube and the transported fluid collecting element and the support bushing are preferably grooved longitudinally over their entire length. The longitudinal groove offers the advantage that the Overtube can be placed at any time during an endoscopic examination on an endoscope and can also be removed again. This groove can be closed by glue, tape, wire, zipper or another technical possibility. The closing mechanism is preferably constructed in such a way that it can be repeatedly opened and closed.
[0116] [0116] Especially preferably the support bushing has proximal and distal end protrusions of lip shape and annular type. An annular shaped lip can also be attached to the proximal and / or distal end of the fluid collecting element. Preferably, this lip is attached by gluing to the fluid collecting element. Preferably, the lip-shaped protrusion of the annular type is pre-molded through a stable pressing and gluing from the fluid collecting medium. The fluid collecting element can be placed on the Overtube laterally.
[0117] [0117] In a special embodiment, the fluid collecting element is made of a thin fluid conductive film with open pores. It especially has the advantage that the diameter of the Overtubes in the section of the fluid collecting element is not essentially enlarged and thus the Overtube can slide unimpeded. However, it must be carefully observed the fact that an open pore film can lead the suction to be exercised in a fluid conductive way so that the fluid collecting element is firmly adhered by suction and fixed.
[0118] [0118] In a variant the Overtube is built to accommodate various fluid collecting elements and drain hoses in different longitudinal segments. In this way, it is advantageously possible for the Overtubes to be anchored not only at the distal end, but also in other locations along the Overtube.
[0119] [0119] In or in the Overtube, other work channels can be provided that move from the proximal to the distal direction longitudinally in the Overtube. They can also be designed longitudinally grooved as in the case of the Overtube for opening and closing. These working channels can be used for washing / vacuuming or introducing instruments.
[0120] [0120] Overtube and also the endoscope are preferably provided with measurement markings so that on the one hand the depth level can be determined, but on the other hand it can also be measured to what extent both are displaced.
[0121] [0121] Vacuum enteroscopy can be performed with conventional endoscopes. In the case of using a conventional endoscope with a vacuum sponge overtube, only vacuum anchoring is used by the vacuum in the fluid collection medium of the Overtube.
[0122] [0122] The length of the Overtube must be selected shorter than the endoscope so that the ability to move in relation to the endoscope is viable. Preferably the endoscope is between 120 and 220 cm long, but other lengths are possible. Preferably, the endoscope has an external diameter of 8 to 12 mm. But other external diameters are also possible.
[0123] [0123] To use the vacuum through a sponge drain on the endoscope, specially constructed endoscopes are required, which will be described below:
[0124] [0124] Preferably, one or more fluid communication elements are integrated in the endoscope. These are preferably designed as plastic channels stable to negative pressure in an endoscope wall, which especially preferably drill at the distal end of the endoscope with one or more drilling holes in the outer cover of the endoscope in order to conduct fluid and end here. These suction channels stable at negative pressure are connected to conductive fluid-stable joints at negative pressure with the vacuum pump so that liquids and gases can be diverted by suction. The fluid communication element (the channel) in the endoscope is preferably cylindrical. Preferably the channel is arranged parallel to a longitudinal axis of the fluid collecting element.
[0125] [0125] Such an endoscope can be used with or without a fluid collecting element. Conventional exams can also be performed using the special endoscope.
[0126] [0126] When using a fluid collecting element it is preferably at the level of the holes of the fluid communication element and is fixed by glue, wires, tightening or an alternative fixation possibility. Preferably, the channel of the fluid collecting element comprises the entire perimeter of the endoscope at the level of the holes of the fluid communication element. The fluid collecting element can also only partially cover the endoscope. In a special embodiment, the fluid collecting element consists of a fluid-conducting film of open pores. This particularly has the advantage that the diameter of the endoscope in the area of the fluid collecting element is not basically larger and that it can slide the endoscope thus unimpeded. It should be noted that the open pore coating can lead to the suction to be carried out without reducing the conduction of fluids, so that the fluid collecting element is adhered fixedly by suction and fixed.
[0127] [0127] Preferably the longitudinal axis of the fluid collecting element basically coincides with the longitudinal axis of the endoscope or is at least parallel to it. In addition, it is preferred that the channel is arranged parallel to a symmetrical axis of the fluid collecting element.
[0128] [0128] Through working channels, endoscopic instruments can be conducted in the endoscope to the distal end of the endoscope. Through these instruments, surgical interventions can be performed, for example, tissue removal, from an endoscopic point of view. The endoscope, for example, can have one or two working channels. These internal working channels are of very small caliber through the arrangement within the endoscope to obtain the smallest possible device diameter for the endoscope.
[0129] [0129] An example of a preferred embodiment foresees a loofah that is fixed on the endoscope, at its distal end and provides an additional external introduction aid for endoscopic instruments or auxiliary elements and / or a washing and suction channel. The bushing is a dimensionally stable hose or a hose-like structure that either does not collapse or break. It is flexible, so you can follow the movements of the endoscope. Another advantage over the internal guide channels is that an external guide channel can have a larger diameter. With this guide bushing, the endoscope, which is equipped with additional external working channels, makes it possible to expand the endoscopic treatment possibilities.
[0130] [0130] For example, at the proximal end, the guide bushing can be closed with a valve to prevent the escape of examination gas.
[0131] [0131] The guide bushing allows, in different embodiments, a simultaneous fixation of one or more external guide channels. It can be manufactured with different diameters.
[0132] [0132] The fixation aid on the endoscope can be configured in the form of a bushing that surrounds the endoscope, rubber, adhesive strip or a fixation device of another type. The fixation aid can be constructed in such a way that it would also be possible to remove the external guide aid in the case of the contained endoscope.
[0133] [0133] Also through the possibility of removing the loofah, new possibilities of endoscopic treatment are obtained. For example, external insertion aid can also be used to advance a guidewire to other endoscopic auxiliary elements. After placing the guide wire, the other external working channel can be removed and through the guide wire under optical control it does not need to be removed for the procedure.
[0134] [0134] In a special embodiment of the vacuum drain it can be inserted (analogously to the internal working channel of the endoscope) also directly through the lumen of the external working channel at the place of placement.
[0135] [0135] Advantageously the lumen of the external working channel is larger than in the case of an external working channel so that under the privileges of direct endoscopic conduction a vacuum drainage can be more voluminous.
[0136] [0136] In a special embodiment, the working channel is equipped distally with lateral drilling holes and connected to a fluid collecting element and thus used as a sponge drain.
[0137] [0137] The insertion cover can also be made in a longitudinal grooved way. In this way, there is a possibility that an instrument introduced by the cover could be released with an endoscope horizontally laterally from the cover and other removable instruments could be placed using the grooved insertion aid.
[0138] [0138] In the following, examples of embodiments that form the negative pressure measuring probes will be described. It is within the scope of that patent application marked with the same meaning as a measurement sensor.
[0139] [0139] The measurement sensor can be placed both during vacuum closure therapy on visible external wounds as well as on intracorporeal wounds that cannot be seen externally to measure the vacuum that is effectively present in the wound. The measurement sensor can be placed during the wound treatment with the fluid collecting element.
[0140] [0140] The measurement sensor (s) are connected directly by wire or wirelessly to the pressure regulating unit of the vacuum system, in a variant with the vacuum pump so that negative pressure values of the pump can be controlled and regulated to be generated, necessary and previously adjusted. The measurement sensor can be placed especially in different embodiments on the polyurethane sponge, in the sponge or between sponge and drain. It can also be arranged within the fluid-conducting system of the drain hose.
[0141] [0141] Preferably, several measurement sensors are present for the measurement of the established negative pressure. If several measurement sensors are present, they can carry out and derive measurements even at different locations, for example at the outlet on the negative pressure side of the pump, in the secretion container, in the fluid collecting element, or in a fluid communication element.
[0142] [0142] In one embodiment, at least one of the measurement sensors is permanently integrated into the pump system. Alternatively or additionally at least one measurement sensor is designed to be inserted later on, for example, a fluid communication element.
[0143] [0143] The drainage unit in this case can be built in such a way that the measurement sensor is already integrated into the system from there, but it can also be placed later, after the fluid collecting element has been placed in the wound, being placed together / in the fluid collecting element. It can be conducted in the fluid communication element to the fluid collecting element or the wound, or it can be conducted to a second fluid communication element separately to the wound site. It is also possible to equip the fluid communication element for this purpose with a second lumen. Advantageously in this case, when the probe is designed in a wire format so that it can be pushed forward like an endoscopic mandarin easily into a small lumen. BRIEF DESCRIPTION OF THE DRAWINGS
[0144] [0144] Preferred embodiments of the invention will be explained below on the basis of figures.
[0145] [0145] Other preferred embodiments of the invention are explained below based on the attached figures according to structure and management.
[0146] [0146] Figure 1a is a schematic illustration of an example of a vacuum system embodiment; Figure 1b is a block diagram with details of the pressure regulation unit of the vacuum system of Fig. 1a Figure 2 is an illustration of partial longitudinal section of the vacuum system of Figure 1 a; Figure 3 is a schematic representation of another example of a vacuum system embodiment; Figure 4 is a schematic representation of an arrangement of a fluid collecting element; Figure 5 is a schematic partial longitudinal cross-sectional illustration of the arrangement of Figure 4; Figure 6 is a longitudinal sectional illustration of a fluid collecting element 64, which is connected in a fluid conductive manner to two fluid communication elements 63, Figure 7 is a longitudinal cross-sectional illustration of a fluid collecting element, in which a fluid communication element is disposed both in a fluid-conductive manner and a negative pressure measurement probe; Figure 8 shows an embodiment of a longitudinally grooved Overtubes; Figure 9 is a longitudinal sectional illustration of Figure 8; Figure 10 is a cross-sectional illustration of an Overtube; Figure 11 is a cross-sectional illustration of another variant of an Overtube; Figure 12 shows another embodiment of an Overtube; Figure 13 is a cross-sectional illustration of the Overtube of Figure 12; Figure 14 is another illustration of the embodiment of Figures 12 and 13; Figure 15 is a longitudinal sectional illustration of Figure 14; Figure 16 is an illustration of an Overtube, which forms a variant of the Overtube from Figures 12 to 15; Figure 17 is an illustration of another variant of an Overtube; Figure 18 is a longitudinal sectional illustration of the Overtube of Figure 17; Figure 19 shows a variant of the illustrations of the embodiments of figure 17 and figure 18; Figure 20 is a longitudinal sectional illustration of the Overtube of Figures 18 and 19; Figure 21 is another longitudinal sectional illustration of the Overtube of Figures 18 to 20; Figure 22 is an illustration of a distal end of an endoscope; Figure 23 is a longitudinal sectional illustration of the endoscope of Figure 22; Fig. 24 is another longitudinal sectional illustration of the endoscope of Fig. 22; Figure 25 is an illustration of a fluid collecting element, which is suitable for use in the Overtube, endoscope and the support bushing; Fig. 26 is a longitudinal sectional illustration of the fluid collecting element of Fig. 25; Fig. 27 is an illustration of another fluid collecting element; Figure 28 is a longitudinal sectional illustration of Figure 27; Figure 29 is an illustration of a support bushing for a fluid collecting element; Figure 30 is a longitudinal sectional illustration of the support bushing of Figure 29; Figure 31 is an illustration of a support bushing with a longitudinally grooved fluid collecting element fixed on it between lip-shaped rings; Figure 32 is a longitudinal sectional illustration of the support bushing of Figure 31; Figures 33 ai show different variants of cross-sectional profiles of ring-shaped annular terminals; Figure 34 is an illustration for clarification of how a flexible endoscope is placed over the Overtube longitudinal groove or removed; Fig. 35 shows an endoscopy arrangement according to another example of embodiment; Fig. 36 an shows a schematic illustration of the examination cycle of a videoendoscopy treatment; Fig. 37 is an illustration of a vacuum drain with partial surface closure of the sponge body; Fig. 38 is a longitudinal sectional illustration of the fluid collecting element of Fig. 37; Fig. 39 is an illustration of another embodiment of a vacuum drain; Fig. 40 is a longitudinal sectional illustration of the vacuum drain of Fig. 39; Fig. 41 is an illustration of a vacuum drain with a profiled surface closure; Fig. 42 is a cross-sectional illustration of the vacuum drain of Fig. 41; Figure 43 is an illustration of a vacuum drain with a tube attached to a sponge body; Fig. 44 is an illustration of another embodiment of a vacuum drain with a tube attached to a sponge body; Fig. 45 is a longitudinal sectional illustration of the vacuum drain of Fig. 43; Fig. 46 is an illustration of another embodiment of a vacuum drain with a drain hose in a sponge body; Fig. 47 is an illustration of a longitudinal section of another vacuum drain with a tube placed in the sponge body; Fig. 48 is an illustration of the vacuum drain of Fig. 47, with a negative pressure applied to the drain hose; Figure 49 is an illustration of another embodiment of a sponge drain, Fig. 50 is a longitudinal sectional illustration of the sponge drain of Fig. 49; Fig. 51 is an illustration of another embodiment of a sponge drain; Fig. 52 is a longitudinal sectional illustration of the sponge drain of Fig. 51; Fig. 53 is an illustration of another embodiment of a sponge drain; Fig. 54 is a longitudinal sectional illustration of the sponge drain of Fig. 53; Figures 55 to h show different variants of a distal end of a sponge drain in the respective longitudinal section illustration. Figures 56 a through f are different illustrations of a drain hose and connection points; Figures 57 a through f are different illustrations of an endoscopic insertion instrument, Figures 58 to and e are different illustrations of another endoscopic insertion instrument; Fig. 59 is an illustration of an insertion aid with a chuck for attachment to a distal end of an endoscope; Figure 60 is an illustration of two insertion aids of different calibers; Fig. 61 shows a cross section of an insertion aid, and of an adapter sleeve with valve; Fig. 62 shows an illustration of an insertion aid with an adapter sleeve over a distal end of an endoscope; and Figure 63 is an illustration of an insertion aid with an adapter sleeve over a distal end of an endoscope. DESCRIPTION OF ACCOMPLISHMENTS OF THE INVENTION
[0147] [0147] Figure 1a is a schematic illustration of an embodiment of a vacuum system with a vacuum pump 11, a secretion container 12 in the pump, a fluid communication element 13, which leads from the vacuum pump up to a fluid collecting element 14. In the fluid communication element, a negative pressure measuring probe 16 is inserted through a side entrance 15, which transmits measured values to the regulation via a pressure regulation unit, preliminary adjustment and electronic control via connector elements 18 on the vacuum pump. Connected to the pressure regulation unit, but in this case not shown in more detail (see Fig. 1b), it is a user input unit. The pressure regulating unit 17 has a measuring signal input for receiving measurement signals from the negative pressure measuring probe 16 designed to drive the vacuum pump 11 during operation for the manufacture and maintenance of vacuum with a pressure negative pre-determined in this example between 60 and 500 mmHg in the hollow volume to be treated in a predetermined evacuation time interval between 0.5 and 5 seconds. The vacuum pump 11 has a control input 11.1.
[0148] [0148] Figure 1b shows a simplified block diagram with details of the pressure regulation unit 17 of the vacuum system of figure 1a. The pressure regulating unit 17 features a control unit 17.1 performed via a programmable microprocessor or a special integrated microcontroller or switch (SIC). The control unit receives measurement signals generated by the negative pressure measurement probe 16. In addition, it is connected with the user input unit Ul. Through the user input unit Ul the doctor can record parameters as a negative pressure a be adjusted, an evacuation time interval and a dead volume present if necessary. This entry does not necessarily have to be made using certain values. Alternatively or additionally, it can be provided, for example, to identify a pre-defined type of exam or therapy by means of menu selection or text input via the user input unit Ul, for which pre-defined negative pressure parameters are stored in a memory 17.2 of the pressure regulation unit (if necessary of its temporal evolution) and the evacuation time interval and can be called up by data entry. The dead volume to be considered if necessary for determining the suction performance of the connected vacuum pump 11 can be registered by the user input alternatively by reading a coding almost automatically.
[0149] i) com o cálculo de um volume morto pré-definido do arranjo de dreno a vácuo conectável à bomba a vácuo, um primeiro desempenho de sucção da bomba a vácuo necessário para o estabelecimento da pressão negativa prédeterminada no volume morto a ser tratado no intervalo de tempo de evacuação pré-definido é apurado e conduzido à entrada de controle 1 1.1 da bomba a vácuo 11 um primeiro sinal de controle correspondente. ii) após o estabelecimento da pressão negativa pré-determinada no volume morto a ser tratado o sinal de medição de pressão é monitorado e em função do sinal de medição de pressão atual é apurado um segundo desempenho de sucção da bomba a vácuo 11 necessário para a manutenção da pressão negativa pré-determinada e conduzido à entrada de controle 11.1 da bomba a vácuo 11 um segundo sinal de controle correspondente; e iii) após o estabelecimento da pressão negativa pré-determinada no volume morto a ser tratado na presença de um desvio da pressão medida ou da pressão negativa que ultrapassa um valor limite predefinido é definido pela pressão negativa pré-determinada é apurado um terceiro desempenho de sucção necessário para o estabelecimento da pressão negativa pré-determinada dentro do intervalo de tempo de evacuação pré-definido e conduzido à entrada de controle 11.1 da bomba a vácuo 11 um terceiro sinal de controle correspondente. [0149] The pressure regulation unit is designed to determine when calling the negative pressure value in the hollow dead volume to be treated that can be selected from a pre-defined range of negative pressure values (automatic value control as admissibility after data entry under consideration of previously stored limit values) and an evacuation time interval, whose value between 0.5 and 5 seconds can be selected, the required suction performance of the pump. For that, other parameters depending on the situation are considered: i) with the calculation of a pre-defined dead volume of the vacuum drain arrangement connectable to the vacuum pump, a first suction performance of the vacuum pump necessary for the establishment of the predetermined negative pressure in the dead volume to be treated in the interval of predefined evacuation time is determined and a corresponding first control signal is sent to control input 1 1.1 of the vacuum pump 11. ii) after establishing the pre-determined negative pressure in the dead volume to be treated, the pressure measurement signal is monitored and, depending on the current pressure measurement signal, a second suction performance of the vacuum pump 11 required for the maintenance of the pre-determined negative pressure and a second corresponding control signal led to control input 11.1 of the vacuum pump 11; and iii) after the establishment of the predetermined negative pressure in the dead volume to be treated in the presence of a deviation from the measured pressure or the negative pressure that exceeds a predefined limit value is defined by the predetermined negative pressure a third suction performance is determined necessary for the establishment of the predetermined negative pressure within the predefined evacuation time interval and led to the control input 11.1 of the vacuum pump 11 a corresponding third control signal.
[0150] [0150] In cases ii) and iii) the dead volume must be considered at first. For a vacuum maintenance it can be irrelevant in a variant. In case iii) he, however, should preferably be considered.
[0151] [0151] Using a switch S, which can also be integrated directly into the user input unit Ul, it is possible to switch from an endoscopy mode to a therapy mode or vice versa. The difference between the modes lies in the range of values available for negative pressure. A patient should not be exposed to high negative pressure values in therapy mode without a doctor present. Such higher negative pressure values are available for this reason only in endoscope mode. Another difference lies in the possibilities of data entry via the user input unit Ul. These are limited in the therapy mode so that the patient cannot make any harmful and unwanted parameter changes. The switch is protected by a key and can only be activated by the doctor who performs the treatment.
[0152] [0152] Figure 2 is an illustration of partial longitudinal section of the vacuum system of figure 1. In the fluid communication element, a negative pressure measuring probe 16 is introduced through a side entrance 15, which through the measurement unit pressure regulation 17 the measured values for regulation, preliminary adjustment and control by connector elements 18 are transmitted to the vacuum pump.
[0153] [0153] Figure 3 is a schematic representation of another example of a vacuum system embodiment, with a prior secretion container 39 for the fastest suction structure and secretion container 32. The previous secretion container is connected via filter / valve 310 to the secretion container. The pressure regulating unit 37 for negative pressure values, time settings, evacuation times and for alarm functions is connected to the vacuum pump 31 with the help of connector elements 38. A fluid collecting element 34 is connected with help of a fluid communication element 33 to the pump unit.
[0154] [0154] Figure 4 is a schematic representation of an arrangement of a fluid collecting element 44, which is connected in a fluid conductive manner to a fluid communication element 43. In the fluid communication element through a side entrance by a valve 411 can move a negative pressure measuring probe 46 in wire form to the fluid collecting element 44. The negative pressure measuring probe is connected to a pressure regulating and measuring unit 47, which can conduct the measurement signals from the negative pressure probe via an electronic connection 48.
[0155] [0155] Figure 5 is a schematic partial longitudinal cross-sectional illustration of the arrangement of figure 4. The fluid collecting element 44 is connected to the fluid communication element 43 at whose distal end there are fluid conducting holes 412 for aspiration. In the fluid communication element, a wire-shaped negative pressure measurement probe 46 is previously guided to the fluid collecting element. At the distal end, the negative pressure measurement sensor 413 of the probe is placed. The measurement sensor is connected to a pressure measurement and regulation unit 47, which can transmit the information via an electrical connection 48.
[0156] [0156] Figure 6 is an illustration of a longitudinal section of a fluid collecting element 64, which is connected in a conductive fluid way to two fluid communication elements 63. In one of the fluid communication elements a temperature measurement probe negative pressure 66 in wire form is brought to the fluid collecting element. A negative pressure sensor 613 is placed at its distal end. Another negative pressure sensor 613a is present in the fluid collector.
[0157] [0157] Figure 7 is a longitudinal sectional illustration of a fluid collecting element 74, in which a fluid communication element 73 is arranged in a fluid conductive manner and a negative pressure measurement probe 76 is arranged on it. in wire format. The negative pressure measurement probe 76 is connected to a pressure measurement and regulation unit 77 and at the distal end it is equipped with a negative pressure measurement sensor 713, which is located on the fluid collecting element. The pressure regulating unit is equipped with an alarm function. Electronic control signals are transmitted to regulate the negative pressure, especially in the vacuum pump. Alarms with respect to an incorrect function may be triggered.
[0158] [0158] Figure 8 is an illustration, showing an execution of an Overtube 81 longitudinally grooved, to avoid injuries during the introduction. A full 86V groove is present throughout the entire length. At the proximal end 83, Overtube 81 is built in a funnel shape to facilitate the introduction of an endoscope. The Overtube is equipped with an 84V fluid communication element in the form of an integrated drainage duct that extends from the proximal to the distal direction. It ends at the distal end in 85V side holes and pierces the Overtube wall with these. At the proximal end it is redirected in the shape of a hose (84V) and can be connected in this case to the vacuum device.
[0159] [0159] Figure 9 is a longitudinal sectional illustration of Overtube 81 of Figure 8, with illustration of Overtube 81, which tapers at the distal end 82, at the proximal end 83 is extended in the shape of a funnel and with the communication element of 84V fluid, which ends at the distal end in 85V fluid-conducting side holes and is channeled proximally in the form of a hose from the wall.
[0160] [0160] Figure 10 is a cross-sectional illustration of another example of an Overtube 101 embodiment with a 104V fluid communication element integrated into the wall. The Overtube 101 is shown with a 106V longitudinal groove.
[0161] [0161] Figure 11 is a cross-sectional illustration of another variant of an Overtube 111, with a 114V fluid communication element integrated in the wall, which is connected to a 115V orifice in a conductive fluid way and pierces the wall and is connected to the outer wall of the Overtube 111 in a fluid-conductive manner. The cross section is marked at the hole level of the 115V wall. The Overtube is shown with a 116V longitudinal groove.
[0162] [0162] Figure 12 is an illustration of an execution of an Overtube 121. A 126V longitudinal groove is present along the entire length. Overtube 121 is equipped with a 124V fluid communication element in the form of a working channel integrated in the wall that extends from a proximal wall orifice 127 of the Overtube to the distal tip and in this case ends with a distal wall orifice 128 .
[0163] [0163] Figure 13 is a cross-sectional illustration of Overtube 121 in figure 12, with the 124V fluid communication element in channel shape provided with a longitudinal groove 1210. The fluid communication element is integrated into the wall. of Overtube 121. The Overtube is also shown with the 126V longitudinal groove.
[0164] [0164] Figure 14 is another illustration of the execution of figures 12 and 13, and in the fluid communication element 124V through the proximal orifice 127, a 1220 medical instrument was introduced, in this case a guide wire was introduced and through it redirected through the distal orifice 128. Figure 15 is a longitudinal sectional illustration of Overtube 121, which shows the working channel 129, which is integrated in the wall of Overtube 121 as well as the proximal orifice of wall 127 and the distal orifice of wall 128.
[0165] [0165] Figure 16 is an illustration of an Overtube 161, which forms a variant of the Overtube from figures 12 to 15. A working channel integrated into the wall of Overtube 161 has over the entire length between proximal lateral orifice 167 and distal lateral orifice 168 a longitudinal groove 1610. Overtube 161 has in this embodiment a longitudinal groove 166V in its entire length.
[0166] [0166] Figure 17 is an illustration of an Overtube 171, with a full 176V slot in its entire length. The Overtube 171 is equipped with two 174V fluid communication elements in the form of drainage ducts, which are integrated into the Overtube wall. They end in 175V side holes at the distal end of the Overtube. The proximal ends 1711 of the fluid communication element are connected to the vacuum unit in a fluid conductive manner. In the Overtube, they are fixed proximally and distally from the 175V side orifices of the 1712V annular shaped lip-shaped fluid communication elements.
[0167] [0167] Figure 18 is a longitudinal sectional illustration of Overtube 171 of figure 17, which shows the two fluid communication elements integrated in the 174V wall, which end in a fluid conductive form laterally at the distal end of the Overtube with 175V holes. From the proximal and distal direction of these, the 1712V ring-shaped protrusions are fixed over the Overtube.
[0168] [0168] Figure 19 shows a variant of the illustrations of the embodiments of 17 and figure 18, in which case in the level of the distal side holes 175V between the 1712V annular shaped protrusions, the fluid collecting element 1713V is fixed. The fluid collecting element is also moved from a 176V longitudinal groove on the longtube of the Overtube 171.
[0169] [0169] Figure 20 is a longitudinal sectional illustration of Overtube 171 of Figures 18 and 19, which clearly shows the fluid communication elements 174V with fluid-conducting side holes 175V, fluid collecting element 1713V fixed there and projections of the type proximal and distal 1712V labial.
[0170] [0170] Figure 21 is another longitudinal sectional illustration of the Overtube of Figures 18 to 20, showing the fluid communication elements 174V with the fluid-conducting side holes 175V and the protrusions of the proximal and distal lip type 1712V. Additionally, in this case, a 1719 wire-format measuring probe is shown, which was inserted into one of the fluid communication elements and which ends distally in a 1721 negative pressure measuring unit. The 1719 measuring probe was introduced in the fluid communication element 174V through a 1722 valve.
[0171] [0171] Figure 22 is an illustration of a distal end of an endoscope 2214. At the distal end of endoscope 2214 there are illustrated side wall holes conducting fluid 225E of a fluid communication element mounted on the endoscope. In the proximal and distal direction of these 225E wall holes, lip-type rings 2212E are attached to the endoscope 2214.
[0172] [0172] Figure 23 is a longitudinal sectional illustration of the endoscope 2214 of figure 22, and shows the fluid communication element 224E located internally, the lip type rings 2212E proximally and distally from the lateral holes 225E of the communication element of 224E fluids.
[0173] [0173] Figure 24 is another longitudinal sectional illustration of the endoscope 2214 of figure 22. In the case of this illustration through the fluid conducting holes of the fluid communication element 224E, a collector element is used between the lip type rings 2212E of fluid 2213E.
[0174] [0174] Figure 25 is an illustration of a fluid collecting element 2513V, 2513E, 2513T, which is suitable for use in the Overtube, endoscope and support bushing. In this embodiment, the fluid collecting element has a conical thinning at its end 2515. In the central part, a channel 2516 is arranged along the longitudinal axis of the fluid collecting element.
[0175] [0175] Figure 26 is an illustration of longitudinal section of the fluid collecting element 2513V, 2513E, 2513T of figure 25. We can see the tapering thinning 2515 at the ends and the central channel 2516 along the longitudinal axis.
[0176] [0176] Figure 27 is an illustration of another fluid collecting element 2713V, 2713E, 2713T for Overtube, endoscope and support bushing and a lip ring 2712V, 2712E, 2712T is attached to the ends of the element. A central 2716 joint channel extends through the fluid collecting element.
[0177] [0177] Figure 28 is a longitudinal sectional illustration of figure 27 with a fluid collecting element 2713, 2713E, 2713 T, with a lip-type ring (2712.2712E, 2712T) attached to the ends.
[0178] [0178] Figure 29 is an illustration of a 2917 support bushing for a fluid collecting element, illustrated with a 296T longitudinal groove, 295T fluid-conductive wall perforations and 2912T lip-type rings proximally and distally from the perforations of 295T wall. The rings are also grooved.
[0179] [0179] Figure 30 is a longitudinal sectional illustration of the support bushing of figure 29 and shows the 295T fluid-conductive wall perforations and the 2912T lip-type rings in a proximal and distal direction of the 295T wall perforations.
[0180] [0180] Figure 31 is an illustration of a wall bushing 3117 with a longitudinally grooved fluid collecting element 3113T fixed on it between lip rings of the 3112T type. Perforations of wall 315T of the support bushing are suggested with dashed lines.
[0181] [0181] Figure 32 is an illustration of the longitudinal section of the support bushing of figure 31, and on the support bushing 3117 between the lip type rings 3112T and in a fluid conductive way with the 315T wall perforations, the fluid collecting element 3113T.
[0182] [0182] Figures 33 a-i show different variants of cross-sectional profiles of the lip ring terminals 3112V, 3112E, 3112T, which are placed on an outer wall 3118V, 3118E, 31 18T of the Overtube, endoscope or support bushing.
[0183] [0183] Figure 34 shows, as a flexible endoscope 3414 in a stage, in which it is placed or removed through the longitudinal groove 346V of an Overtube 341. Fluid collecting elements 3413E, 3413V are placed on the endoscope and the Overtube respective distal end. The 344V fluid communication element is connected in a conductive fluid way to the fluid collecting element of the Overtube 3413V.
[0184] [0184] Figure 35 shows an endoscopy arrangement, according to another example of embodiment. A 3521 vacuum pump unit is illustrated with a 3522 secretion collection container, to which an Overtube 351 and a 3514 endoscope are connected. At the distal ends of the Overtube 351 and the 3514 endoscope, fluid collecting elements 3513V and 3513E are attached, which are connected to the fluid communication elements 354V (Overtube), and 354E (endoscope) with the 3521 vacuum pump unit.
[0185] a) introdução do endoscópio 3614 com elemento coletor de fluido 3613E no intestino 3625 de um paciente; b) posterior condução do Overtube 361 com elemento coletor de fluido 3613V através do endoscópio; c) ativação do elemento coletor de fluido 3613V com vácuo; d) avanço do endoscópio 3614 para dentro do intestino; e) ativação do elemento coletor de fluidos 3613E no endoscópio 3614 com vácuo, sendo que neste caso não é feita ativação a vácuo do elemento coletor de fluidos 3613V sobre o Overtube 361; f) deslize gradual do Overtube 361 através do endoscópio fixado 3614; g) ativação de ambos os elementos coletores de fluido 3613E e 3613V com vácuo; h) manobra de correção de inclinação opcional se necessária, puxando o elemento coletor de fluido 3613E juntamente com o elemento coletor de fluido 3613V, ambos aplicação de vácuo; i) desligamento da aplicação de vácuo do elemento coletor de fluidos 3613E durante manutenção da aplicação de vácuo do elemento coletor de fluidos 3613V; j) avanço do endoscópio 3614 no caso de Overtube 361 fixado por vácuo; k) manutenção da aplicação de vácuo do elemento coletor de fluidos 3613E, desligamento da aplicação de vácuo do elemento coletor de fluidos 3613V; l) desliza gradual do Overtube 361 com endoscópio fixado a vácuo 3614; m) aplicação de vácuo de ambos os elementos coletores de fluido 3613E e 3613V; n) manobra de correção de inclinação puxando o elemento coletor de fluidos 3613E juntamente com o elemento coletor de fluido 3613V, ambos sob vácuo; [0185] Figure 36 an is a schematic representation of the examination cycle for a vacuum endoscopy. The treatment comprises the following steps: a) introduction of endoscope 3614 with fluid collecting element 3613E in a patient's intestine 3625; b) subsequent conduction of Overtube 361 with a fluid collecting element 3613V through the endoscope; c) activation of the 3613V fluid collecting element with vacuum; d) advancing endoscope 3614 into the intestine; e) activation of the fluid collecting element 3613E in the endoscope 3614 with vacuum, in which case no vacuum activation of the fluid collecting element 3613V is made on the Overtube 361; f) gradual slide of the Overtube 361 through the endoscope fixed 3614; g) activation of both fluid collecting elements 3613E and 3613V with vacuum; h) optional tilt correction maneuver if necessary, pulling the fluid collecting element 3613E together with the fluid collecting element 3613V, both applying vacuum; i) shutting down the vacuum application of the fluid collecting element 3613E while maintaining the vacuum application of the fluid collecting element 3613V; j) advancement of endoscope 3614 in the case of Overtube 361 fixed by vacuum; k) maintenance of the vacuum application of the fluid collecting element 3613E, shutting down the vacuum application of the fluid collecting element 3613V; l) gradual slide of Overtube 361 with endoscope fixed to vacuum 3614; m) vacuum application of both fluid collecting elements 3613E and 3613V; n) tilt correction maneuver by pulling the fluid collecting element 3613E together with the fluid collecting element 3613V, both under vacuum;
[0186] [0186] Then, the examination can be continued with step i) and the following.
[0187] [0187] Figure 37 is an illustration of a fluid collecting element (a vacuum drain) in the form of a sponge body 371 with partial surface closure 374 of the sponge body 371. In a drain hose 372, which is A guide wire 373 is inserted into the sponge body 371 in this illustration.
[0188] [0188] Figure 38 is a longitudinal sectional illustration of the fluid collecting element 371 of figure 37. We can see the surface closure 374 of the sponge body 371 with drain hose 372, which has drilling holes 372a laterally and in which a guide wire 37 is placed.
[0189] [0189] Figure 39 is an illustration of another embodiment of a vacuum drain 391 with a drain hose 392 and a guide wire present there 393. On the outside of the sponge body 391 a seal is placed in the form shell 395, which at the proximal end has a funnel-shaped widening 395a.
[0190] [0190] Figure 40 is a longitudinal sectional illustration of vacuum drain 391 of figure 39, which also shows the shell-shaped seal 395 on the outer side of the vacuum drain sponge body 391, which is extended at the proximal end funnel-shaped (395a). We can also see the drain hose 392, which has lateral drilling holes 392a and in which a guide wire 393 is located.
[0191] [0191] Figure 41 is an illustration of a vacuum drain in the form of a sponge body 411 with a profile surface seal 416 of the sponge body 411. A drain wire 413 is placed in the drain hose 412. The seal surface 416 has a fluted profile 416a with longitudinal ridges that pass adjacent to each other in the longitudinal direction of the sponge body 411.
[0192] [0192] Figure 42 is a cross-sectional illustration of the vacuum drain in figure 41. In the drain hose 412, the guide wire 413 enters. The surface seal shows its longitudinal profile 416a.
[0193] [0193] Figure 43 is an illustration of a vacuum drain with a tube 437 attached to the sponge body 43.7 In the sponge body 431 a drain hose 432 is placed, in which a guidewire 433 is contained. At the proximal end a funnel-shaped enlargement 437a is present in the vacuum drain. In the tube 437, an installation bar 438 is inserted, which passes through the distal end 438a in a conical shape. Another guide wire is placed on the installation bar 438. A booster 439 is placed at the proximal end of the installation bar.
[0194] [0194] Figure 44 is an illustration of another embodiment of a vacuum drain with a tube 447 attached to a sponge body 441 which has a funnel-shaped enlargement at the proximal end 447a. A 4410 endoscope is inserted into the tube. At the proximal end of the 4410 endoscope, a booster 449 is placed. The tube 447, sponge body 441 and booster 449 are equipped with a full lateral longitudinal groove 4412. A sponge body 4411 is fitted with a hose drain 442, this is a guide wire 443.
[0195] [0195] Figure 45 is a longitudinal sectional illustration of the vacuum drain of figure 43. In the sponge body 431 there is the tube 437, which at the proximal end has its funnel-shaped enlargement 437a. The installation bar 438 is located in tube 437. A 433 guide wire is placed on installation bar 438. Booster 439 is placed on the installation bar. Sponge body 431 contains drain hose 432 with side holes. 432a. In the drain hose 432 there is another guidewire 433a.
[0196] [0196] Figure 46 is an illustration of another embodiment of a vacuum drain with a drain hose 462 in the sponge body 461. In the sponge body of the vacuum drain there is a tube 467, which has broken ends in the proximal and distal 467b. The arrows show in which direction the broken ends 467b can open.
[0197] [0197] Figure 47 is an illustration of a longitudinal section of another vacuum drain with a tube present in the sponge body 471 which can open at its ends 477b under suction outwards. In tube 477, an endoscope 4710 is inserted. In the sponge body 471 there is a drain hose 472 with side holes 472a. The vacuum drain is located in an intestinal segment through which a 4713 intestinal wall is suggested.
[0198] [0198] Figure 48 is an illustration of the vacuum drain in figure 47, with a negative pressure applied to the drain hose 472. The sponge body 471 is therefore collapsed and the intestinal wall 4713 abuts the sponge body 471. Movable ends 477b of tube 477 are turned outward in the direction of the arrow.
[0199] [0199] Figure 49 is an illustration of another embodiment of a vacuum drain, which is marked under that patent application with the same meaning as sponge drainage. A sponge body 491 is attached to a drain hose 492a. The drain hose 492 exits proximally and distally out of the sponge body. A 493 guide wire was introduced into the drain hose 492a.
[0200] [0200] Figure 50 is a cross-sectional illustration of the sponge drainage of figure 49. The sponge body 491 is attached to the drain hose 492a through drilling holes 494. A wire 493 is introduced into the drain hose.
[0201] [0201] Figure 51 is an illustration of another way of carrying out a sponge drain. Two sponge bodies 511 are fixed at a distance over the drain hose 512a. A guide wire 513 was introduced into the drainage hose 512. This embodiment is advantageous if, for example, an intestinal segment is functionally separated with a fistula.
[0202] [0202] Figure 52 is a cross-sectional illustration of the sponge drainage in figure 51. We can observe the two sponge bodies at a distance fixed on the drain hose 512a through drilling holes 514. The guide wire 513 is inserted into the drain hose.
[0203] [0203] Figure 53 is an illustration of another way of carrying out a sponge drain. A sponge body 531 is attached to a drain hose 532a. The drain hose 532a tapers to a thin lumen drain hose 532b. A 533 guidewire is inserted into the drain hose.
[0204] [0204] Figure 54 is a cross-sectional illustration of the sponge drainage in figure 53. The sponge body 531 is attached to the drain hose 532a through drilling holes 534. The drain hose 532a tapers into a hose thin lumen drainage system 532b. The 533 guidewire is inserted into the drain hose.
[0205] [0205] Figures 55 to h show different variants of a distal end of a sponge drain 551 in the respective cross-sectional illustration, the sponge body 551 is attached to a drain hose 552a through drilling holes 554. A drain hose 552a ends at a tip 555. In figure 55a a wire 556 is attached to tip 555. In figure 55b a wire or wire loop 557 is attached. In figure 55c at tip 555 a wire 556 is attached In this case, however, the tip has a channel 558, through which a guide wire 553 can be executed. In figure 55d, the sponge body 551 is configured at its distal end as a tip. The sponge body also has a channel 558 here, through which a guide wire 553 has been placed. In figure 55e, the sponge body 551 is configured at the distal end as a tip as well. The sponge body 551 has a channel 558, through which a guide wire 553 has been placed. A loop of wire or wire 57 is attached to the sponge body. In figure 55f, a 559 clamping pearl is attached to the tip 555. In figure 55g, an eyelet 5510 is attached to the end through which a wire 5511 was pulled. In figure 55h the gripping pearl 559 is located on the sponge body 551.
[0206] [0206] Figures 56a through f are different illustrations of a drain hose 562a and connection tips 5612. Figure 56a is an illustration of a drain hose 562a and a connection tip 5612. The connection tip has at the end distal a grasping pearl 569, at the proximal end a screw thread 5612a. Fig. 56b is an illustration, in which connection point 5612 is screwed onto drain hose 562a. Figure 56c is a longitudinal sectional illustration of Figure 56a with drain hose 562a and connection tip 5612. Figure 56d is a longitudinal sectional illustration of Figure 56c, with connection point 5612 screwed into drain hose 562a. Fig. 56e is a longitudinal cross-sectional illustration of connection tip 5612 screwed to drain hose 562a which is equipped with a cross channel 5612b. Fig. 56f is a longitudinal cross-sectional illustration of a variant of connecting tip 5612 screwed onto drain channel 562a. The connecting tip is equipped with a 5612c channel. Through channel 5612c and drain hose, a guide wire 563 is introduced.
[0207] [0207] New installation instruments suitable for vacuum therapy will be described below.
[0208] [0208] Endoscopic gripping or installation instruments are used to place the vacuum drain. The placement can be carried out in the advance technique or in the traction (passage) technique. When placing in orthography, an endoscopic installation instrument is inserted into the working channel of the endoscope or external working channel. It runs at the distal end of the endoscope. For the placement of the drain, the traction (passage) technique is used when the wound to be treated can be reached via an artificial or natural access route internally via endoscopy and on the other hand there is still an external access route, for example in the form of an external fistula.
[0209] [0209] The traction (passage) technique is also applied when endoscopic vacuum therapy is used in combination with open or laparothoracic endoscopic operations (Rendezvous method). It can also be used for the placement of conventional drains during Laparoscopy.
[0210] [0210] In the example of a therapy in the case of esophageal leak with the placement of a fistula, the traction technique must be represented by the traction technique. With the aid of a guidewire or an endoscope, the installation instrument is brought from outside through a fistula orifice into the esophagus. At the same time, an endoscope is introduced through the mouth into the esophagus and inserted to the point of leakage. If the installation instrument is placed in the unsealed esophagus, it will be captured by a loop and again executed through the mouth. The installation instrument is coupled with its fixing mechanism to the distal end of the fluid communication element, to the connecting tip or to the sponge body and fixed. With endoscopic visualization, the installation instrument is approached, the drain enters by traction through the mouth into the esophagus. The exact positioning is controlled endoscopically through the esophagus. The installation instrument is released again from the coupling on the drain and removed by pulling. When the tip of the fluid communication element, connecting tip or sponge body is provided with a wire, the above maneuver can be performed with a wire using the above technique.
[0211] [0211] The traction (passage) technique can be specially used when a drain construction is selected in which the sponge body is located in the central segment of the fluid communication element. Then, the sponge body can be positioned by being pulled towards one end of the fluid communication element. It can be via only one side of the fluid communication element, simultaneously on both sides or alternately sucked.
[0212] [0212] The installation instrument is composed of a pearl grip. A core made of metal or plastic material is inserted into a plastic bushing. The nucleus divides at its distal end into two or more leaves. At the distal end of the core there is a tension of the leaves outwards so that it opens during the exit out of the distal end of the bushing in the form of a flower and the retreat into the bushing is closed. The leaves are spoon-shaped at the end so that during the closing of the core a hollow spherical or lens-shaped compartment is formed. At the distal end, a small hole remains after closing. In the flower-shaped core, the gripping pearl of the connection tip, of the fluid communication element or of the fluid collecting element can be inserted. When the core is closed, the pearl catches. During the opening it is released again and the installation instrument and clamping pearl are uncoupled.
[0213] [0213] The installation instrument is especially advantageously designed to accommodate a guidewire. The pearl claw can be inserted into the working channel of an endoscope. The installation instrument is especially long from 80 cm to 250 cm.
[0214] [0214] Another installation instrument is composed of a hook. A wire-shaped core made of metal or plastic is inserted into a plastic bushing. At the distal end, the core is equipped with a hook with which a loop of wire or an eye can be captured. After extending the hook out of the bushing, the wire loop or eye of the connecting tip, the fluid communication element or the fluid collecting element can be attached by pulling the hook. During the opening of the hook, the joint is released again. A guide wire can be placed especially advantageously on the installation instrument. The hook can be inserted into the working channel of an endoscope.
[0215] [0215] Furthermore, it proved to be quite useful to provide at the end with a traction-resistant gripping pearl, wire or wire loop, eye and / or a wire, the tip of which in the latter case has a channel that passes transversely through which the wire can be inserted.
[0216] [0216] Figures 57 a through f are different illustrations of an endoscopic installation instrument 5713a / b, with which a 579 clamping pearl can be attached. Figure 57a is an illustration of the open instrument. From a bushing 5713a a core of two sheets 5713b is guided outwards, which has opened. In addition, a 573 guidewire exits the bushing. In figure 57b, the guide wire 573 is pulled back, the gripping pearl 579 is gripped with the core 5713b. In figure 57c it is illustrated how the gripping pearl was attached. Core 5713b was pulled into bushing 5713a in which case core 5713b closed. In figure 57d the closed core 5713b is shown, which secured the gripping pearl 579 and was pulled back into the bushing 5713a. Figure 57e is a longitudinal sectional illustration of 57a with bushing 5713a, open core 5713b, guide wire 573 and clamping pearl 579. Figure 57f is an illustration of longitudinal section of 57d. The closed core 5713b was pulled back with the clamping pearl 579 into the bushing 5713a.
[0217] [0217] Figures 58 to and up are different illustrations of another endoscopic installation instrument, with which a 5810 eye can be attached. Figure 58a is an illustration of the open instrument. A 5814b hook is driven out of a 5814a bushing. In addition, a 583 guidewire comes out of the bushing. In figure 58b the guide wire 583 is pulled back, the eye 5810 is secured with hook 5814b. Figure 58c shows how the hook was pulled back with the eye attached 5810 into the bushing 5814a. Figure 58d is a longitudinal sectional illustration of the installation instrument of figure 58a, with chuck 5814a, hook 5814b, guide wire 583 and eye 5810. Figure 58e is a longitudinal sectional illustration of Fig. 58c. The hook 5814b had been pulled back with the eye attached 5810 into the sleeve 5814a.
[0218] [0218] Figure 59 is an illustration of an insertion aid 591 with a chuck 592 for fixation on a distal end of an endoscope. The insertion aid 591 is chamfered at the distal end and the longest side of the chamfer is over the endoscope, to avoid injury during the introduction of the endoscope. At the proximal end there is a 593 valve to prevent the examination gas from escaping.
[0219] [0219] Figure 60 is an illustration with 2 insertion aids 601 of different caliber.
[0220] [0220] Figure 61 shows a longitudinal section of an insertion aid 611, an adapter sleeve 612 with valve 613.
[0221] [0221] Figure 62 shows an illustration of an insertion aid 621 with an adapter sleeve 622 on a distal end of an endoscope 624.
[0222] [0222] Figure 63 is an illustration of an insertion aid 631 with an adapter sleeve 632 on a distal end of an endoscope 634. In the insertion aid an endoscopic forceps 635 was introduced.

权利要求:
Claims (38)
[0001]
VACUUM SYSTEM FOR ENDOSCOPIC VACUUM THERAPY, intracavitary, intraluminal or intracorporeal for aspiration of body fluids, wound secretions or gases coming from a hollow volume such as a body cavity, hollow organ, tissue abscess or intestinal lumen , especially in the case of the manufacture of a transient endoscopic closure of an intestinal lumen, characterized by the vacuum system comprising: - a vacuum pump, which has a control input for receiving a control signal to control its suction performance and features on the negative pressure side a connection for a vacuum drain arrangement, and - a pressure regulating unit connected or connectable to the vacuum pump control input, - and which has a measurement signal input for receiving at least one pressure measurement signal, which forms a measurement for a dominant negative pressure or pressure in the hollow volume to be treated, - and which is designed accordingly: a) with a negative pressure value in the hollow volume to be treated that can be selected from a predefined negative pressure value range, and b) with an evacuation time interval, the value of which is between 0.5 and 5 seconds can be selected, i) determine based on a predetermined dead volume of the vacuum drain arrangement that can be connected to the vacuum pump, to determine the first suction performance of the vacuum pump necessary for the establishment of the predetermined negative pressure in the volume hollow to be treated in the predefined evacuation time interval, and lead to the vacuum pump control input a corresponding first control signal, ii) after establishing the pre-determined negative pressure in the hollow volume to be treated, monitor the pressure measurement signal, and depending on the current pressure measurement signal, determine a second suction performance of the vacuum pump required for the maintaining the pre-determined negative pressure and conducting a second corresponding control signal to the vacuum pump control input; and iii) after the establishment of the pre-determined negative pressure in the hollow volume to be treated, in the event of a deviation from the measured pressure or negative pressure that exceeds a pre-defined limit value, determine a third suction performance of the vacuum pump necessary for the establishment of the pre-determined negative pressure within the pre-defined time interval and lead to the control input a corresponding third control signal; being that - the vacuum pump is designed to generate on the negative pressure side as a function of the control signal present at its control input a certain suction performance through the control signal.
[0002]
SYSTEM, according to claim 1, characterized in that the pre-defined negative pressure value range extends over negative pressure values in relation to an ambient pressure between a minimum negative pressure of 60mmHg and a maximum negative pressure of 500mmHg.
[0003]
SYSTEM according to claim 1, characterized in that it further comprises a user input unit connected to the pressure regulation unit which is designed to accept a user input from the evacuation time interval and / or from a negative pressure value and forward to the pressure regulating unit, and in which the pressure regulating unit is designed to determine the control signal in question under the inclusion of the current user input and forward to the vacuum pump control input.
[0004]
SYSTEM according to any one of claims 1 to 3, characterized in that the user input unit has a lockable mode switch, which allows adjustment on the user side or in a therapy mode or an endoscopy mode, the pressure regulation unit being designed to emit in the therapy mode only the second or third control signal but not the first control signal and the predefined negative pressure value range extends in the therapy mode about negative pressure values in relation to an ambient pressure between a minimum negative pressure of 60mmHg and a maximum negative pressure of 250mmHg.
[0005]
SYSTEM according to any one of claims 1 to 4, characterized in that it has a vacuum drain arrangement which is connected to the vacuum pump on the negative pressure side and which presents a negative pressure-stable secretion collection container that is designed to during operation, house and / or divert secretion that forms or gas that is sucked in by the gas pump and in which the pressure regulation unit is designed to include a volume of the secretion collection container as part of the dead volume.
[0006]
SYSTEM, according to claim 5, characterized in that the vacuum drain arrangement additionally features a preliminary secretion collection vessel which is connected upstream to the secretion collecting vessel and is connected to it in a fluid-conducting manner and in which the unit pressure regulating valve is designed to include a volume of the secretion collecting container as another part of the dead volume.
[0007]
SYSTEM according to any one of claims 5 to 6, characterized in that the pressure regulating unit is designed to include an additional volume that forms at least one fluid communication element stable at negative pressure, especially a drain hose that can be connected distally to a fluid collecting element and proximal to the secretion collecting container or to the previous secretion collecting container, as another part of the dead volume.
[0008]
SYSTEM according to any one of claims 1 to 7, characterized in that the vacuum pump comprises a pump combination of at least two pump units, of which a first pump unit is formed, to generate a preliminary vacuum, which presents a pressure negative pressure less than the predetermined negative pressure and a second pump unit that is designed to establish a vacuum after the preliminary vacuum is established.
[0009]
SYSTEM according to any one of claims 1 to 8, characterized in that the pressure regulating unit is designed to supply the vacuum pump initially and temporarily with a first, higher, pre-determinable negative pressure after a period of time has elapsed. predeterminable by user input regulating the negative pressure to a second comparable, low predeterminable negative pressure value.
[0010]
SYSTEM according to any one of claims 1 to 9, characterized in that the vacuum pump has a plurality of connections on the negative pressure side for both ends of a single drain hose or one or more ends of several drain hoses, and in which the pressure regulating unit is designed to actuate the vacuum pump based on the user input via the user input unit, optionally aspirating or washing either on one side only on one of the connections or alternately on two of the connections or simultaneously on two connections.
[0011]
ENDOSCOPY ARRANGEMENT, characterized by understanding: - a vacuum system as defined in any one of claims 1 to 10, - an overtube unit, which is connected on the negative pressure side to the vacuum pump of the vacuum system via at least one fluid communication element and which carries a fluid collecting element, - an endoscope, which is inserted or introduced into the Overtube unit and can move relatively relative to the Overtube unit in a direction that points from proximal to distal or vice versa, and - a negative pressure measuring probe, which is connected to the pressure regulating unit of the vacuum system.
[0012]
ARRANGEMENT, according to claim 11, characterized in that the endoscope on the negative pressure side is connected to the vacuum pump of the vacuum system through a fluid communication element in the form of drain hoses and / or in the form of a channel in the endoscope and carry another fluid collecting element.
[0013]
ARRANGEMENT according to any one of claims 11 to 12, characterized in that the fluid collecting element is attached to the distal end of the Overtube unit and / or the other fluid collecting element is attached to the distal end of the endoscope.
[0014]
ARRANGEMENT, according to any one of claims 12 to 13, characterized in that the endoscope has at least one working channel that passes inside it, which has outward drilling holes, through which the other fluid collecting element is connected conductive form of fluid.
[0015]
ARRANGEMENT according to any one of claims 11 to 14, characterized in that the fluid collecting element or the other fluid collecting element has a polyurethane sponge.
[0016]
ARRANGEMENT according to any one of claims 11 to 15, characterized in that the fluid collecting element or the other fluid collecting element has an open pore fluid conducting film or in which the fluid collecting element or the other fluid collecting element has additionally on its outer surface a fluid conductive film of open pores.
[0017]
ARRANGEMENT, according to claim 16, characterized in that the film is formed towards the endoscope in a fluid-conductive manner.
[0018]
ARRANGEMENT according to any one of claims 11 to 17, characterized in that the endoscope carries a polyurethane sponge as the other fluid-collecting element while the Overtube unit provides the film-collecting element as the fluid-collecting element.
[0019]
ARRANGEMENT according to any one of claims 11 to 18, characterized in that it has a vacuum system as defined in claim 9, in which both longitudinal ends of the drain hose have a connection for the connection with the vacuum pump and in which the sponge drain unit is attached between the longitudinal end of the drain hose.
[0020]
ARRANGEMENT according to any one of claims 11 to 19, characterized in that the fluid collecting element and / or the other fluid collecting element is provided by segments of a surface seal for closing open pores and in other segments it does not have the surface seal.
[0021]
ARRANGEMENT according to any one of claims 11 to 20, characterized in that the drain hose ends distally with a conical tip.
[0022]
ARRANGEMENT, according to claim 21, characterized in that a gripping pearl, a wire-to-wire loop, an eye and / or a wire is fixed in such a way as to allow tensile strength at the tip of the drain hose; the tip in the latter case having a channel that passes transversely into which the wire can be introduced.
[0023]
ARRANGEMENT, according to claim 22, characterized in that the distal end of the drain hose is a projectile-type connecting tip made of plastic or metal, which is designed to be fixed in a tensile resistant manner to a fitting element and / or threaded at the end of the drain hose.
[0024]
ARRANGEMENT according to any one of claims 11 to 23, characterized in that the drain hose is designed to configure the introduction of a guidewire into the lumen of the drain hose and in which a distal end of the drain hose and the protrusion end feature a longitudinal channel into which the guidewire can be inserted.
[0025]
ARRANGEMENT according to any one of claims 11 to 24, characterized in that a sponge body of the fluid collecting element ends distally with a tip and on the tip and / or on the integrated sponge body is fixed in a tensile-resistant manner gripping pearl, wire-to-wire loop, eye and / or a wire.
[0026]
ARRANGEMENT according to any one of claims 11 to 25, characterized in that one of the negative pressure measuring probes is disposed inside, on or next to the fluid collecting element in the distal direction and is connected to the pressure regulation unit of the pressure system vacuum.
[0027]
ARRANGEMENT, according to claim 26, characterized in that this negative pressure measurement probe is designed in wire format and is introduced through the drain hose to the fluid collecting element.
[0028]
ARRANGEMENT, according to any one of claims 11 to 27, characterized in that the Overtube presents in a proximal and distal direction next to the fluid collecting element supported on it, directly having an annular-shaped lip-type thickening adjacent to it.
[0029]
ARRANGEMENT according to any one of claims 11 to 28, characterized in that the drain hose has different diameters in different longitudinal segments.
[0030]
ARRANGEMENT, according to any one of claims 11 to 29, characterized in that the fluid collecting element has a sponge body, which has at least one cavity on its external surface or inside it a channel for the accommodation of a shell that can be inserted for the operation of the endoscopy arrangement within the cavity or channel.
[0031]
ARRANGEMENT according to any one of claims 11 to 30, characterized in that a sponge body of the fluid collecting element is arranged in a channel directed from proximal to distal direction, through which a tube with pores of the sponge body connected is not connected. conductive form of fluid to conduct body fluids such as secretion or saliva.
[0032]
ARRANGEMENT, according to claim 31, characterized in that it is stable at negative pressure and has a length of 5 to 20 cm and an internal diameter of 5 to 20 mm.
[0033]
ARRANGEMENT according to any one of claims 31 to 32, characterized in that it is internally hydrophilic and in which a surface seal of the fluid collecting element is hydrophilic.
[0034]
ARRANGEMENT according to any one of claims 31 to 33, characterized in that a proximal end and / or a distal end of the tube are movable outwardly relative to a central part of the tube and expandable under the application of negative pressure.
[0035]
ARRANGEMENT according to any one of claims 31 to 34, characterized in that the tube is located without fixation in the channel of the sponge drain unit.
[0036]
ARRANGEMENT according to any one of claims 11 to 35, characterized in that the outer diameter of the fluid communication element and the fluid collecting element are adapted to an internal diameter of an internal working channel of the endoscope so that they are displaceable within of the working channel and its positioning can be carried out through the internal working channel of the endoscope.
[0037]
ARRANGEMENT according to any one of claims 11 to 36, characterized in that the fluid collecting element has a sponge body and a channel placed in the sponge body is equipped with a surface seal which is made of a longitudinally profiled film, which is profiled through fluid-conducting channels in the longitudinal direction that points from the proximal to the distal.
[0038]
ARRANGEMENT according to any one of claims 11 to 37, characterized in that the Overtube, the fluid collecting element, the impeller and the external working channel are provided with a longitudinal groove that extends over the total length.

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法律状态:
2017-07-04| B15I| Others concerning applications: loss of priority|

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2017-09-19| B12F| Appeal: other appeals|

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2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-07-14| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-01| B09A| Decision: intention to grant|

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2020-12-22| B09X| Decision of grant: republication|

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2021-01-05| B09W| Decision of grant: rectification|Free format text: ATRAVES DO CODIGO 261, PETICAO NO 870200157422 E INFORMADO QUE FOI APRESENTADA EM 12/03/2015 SOB PETICAO 018150003224 COM OS DESENHOS QUE DEVERAO COMPOR A CARTA-PATENTE. |

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2021-01-26| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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DE102011013743.2|2011-03-11|

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DE102011013744A|DE102011013744A1|2011-03-11|2011-03-11|Vacuum endoscopy system for endoscopic examination of gastro-intestinal track, has vaccum pump unit that is provided with receptacle to which over tube and endoscope are attached|

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DE102011013743A|DE102011013743A1|2011-03-11|2011-03-11|Vacuum system for intraluminal, intracavitary, intracorporeal, endoscopic vacuum therapy for treating internal wounds, has vacuum pump unit, which is connected in liquid conducting manner with liquid collecting element|

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DE102011013744.0|2011-03-11|

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DE102011120411.7|2011-12-08|

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DE102011120411|2011-12-08|

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DE201210003129|DE102012003129A1|2012-02-17|2012-02-17|Vacuum system for endoscopy arrangement, for endoscopic intracavity, intraluminal or intracorporeal vacuum therapy, for aspirating body fluids, wound secretions or gases, has vacuum pump which has control input for receiving control signal|

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DE102012003129.7|2012-02-17|

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PCT/EP2012/054276|WO2012123414A1|2011-03-11|2012-03-12|Vacuum system and endoscopy arrangement for endoscopic vacuum therapy|

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