Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
  • A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/12—Audiometering
  • A61B5/121—Audiometering evaluating hearing capacity
  • A61B5/125—Audiometering evaluating hearing capacity objective methods
  • A61B5/126—Audiometering evaluating hearing capacity objective methods measuring compliance or mechanical impedance of the tympanic membrane
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3344—Measuring or controlling pressure at the body treatment site
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers

Definitions

• the invention relates to a method for determining the compliance of a cavity in minimally invasive operations and devices for performing the method
• a cavity or the operating area in the human body needs to be expanded. Examples of this are the abdomen or the bladder.
• the required volume of a fluid eg CO 2 , saline solution
• CO 2 a fluid that varies in order to expand this cavity in such a way that a sufficient field of vision is made possible for the surgical intervention.
• liquid fluids such as saline solutions
• peristaltic pumps are used here, which can vary the volume flow 15 by controlling the pump rotation.
• the cavity By introducing the volume flow into the cavity, the cavity is filled with the fluid and the pressure in this cavity increases. At the same time, the cavity expands to such an extent that the field of vision is enlarged.
• Pressure sensors used to determine the cavity pressure.
• the necessary volume flow can be calculated by means of suitable regulation without it being harmful to the patient
• CONFIRMATION COPY Cavity pressure is coming.
• the necessary volume flow will be realized accordingly via the regulation of the pressure reducer or the peristaltic pump. It should be noted, however, that the pressure is not measured during the insufflation: For the pressure measurement, the insufflation is interrupted for a short time so that a pressure equilibrium is established, which represents the actual pressure in the body cavity. After the measurement, insufflation continues.
• the user of the device currently has to make a large number of necessary settings in order to convey the information about the intended indication and cavity size to the device.
• the parameters and limit values for the control / regulation of the device are derived from this.
• data records are thus loaded that quantify the maximum permissible delivery rate of the fluid.
• the body cavity is larger than originally assumed, the expansion of the body cavity takes a very long time and there are unwanted delays in the operation. If, on the other hand, the body cavity is smaller than originally assumed, pressures may be reached very quickly, which can lead to tissue damage.
• Another problem can arise if the treating staff misses the body cavity with the gas-supplying Veress needle. In this case, emphysema may develop, which can be very painful.
• the device may behave incorrectly.
• a non-adapted limitation of the maximum delivery rate could lead to an undesirable time delay in the operation, or to high pressure loads in the other case.
• the devices and methods known from the prior art have so far not been able to solve the problems described.
• the relevant prior art includes the documents US 2007/0083126 A1, US 2010/0236555 A1, DE 4309380 A1, DE 19809867 C1,
• the present invention discloses a medical device for introducing a fluid into a body cavity, which device determines the parameters of a cavity and thus independently determines the necessary operating parameters.
• FIG. 2 shows a medical device (3) according to the invention for conveying fluid with the following components:
• the fluid can be a gas (eg CO 2 or N or a liquid (eg saline solution).
• a regulated pump (actuator or delivery unit) (4) to deliver the fluid in a regulated manner.
• a pressure sensor (6) to determine the dynamic and static pressure of the fluid.
• a connecting element (7) e.g. hose to convey the fluid from the device to the body cavity (8).
• An electronic storage element (not explicitly shown) which is used to record measurement data. Furthermore, an electronic processing unit (e.g. microcontroller) to set the necessary control commands to actuators, to evaluate data, to load / write parameter data sets from the memory element.
• an electronic processing unit e.g. microcontroller
• the compliance of the cavity can be determined automatically on the basis of the values of the volume flow and pressure so that operating errors by the medical staff are avoided.
• Various determination methods can be used for this, which are described below.
• the device is first connected to the body cavity by means of a connecting element. The device is then switched on. Before the initial introduction of a volume flow, the device determines the pressure in the cavity. A predefined temporal volume flow q is then generated by means of the actuator (eg a pulse-shaped volume flow with a defined temporal length). The volume flow creates a pressure increase q c in the cavity.
• the volume V can be determined by integrating the volume flow measurement unit.
• the device stops pumping after the defined volume flow and determines the static pressure in the cavity.
• the elasticity can thus be determined from the partial pressure increase (dp c / dV c ).
• This procedure can be repeated until a desired target pressure is reached in the cavity.
• the so-called P-V diagram can then be derived from the partial pressure increases. This diagram therefore provides information about the size of the cavity or the location of the indication.
• the parameterization and selection of optimal system parameters e.g. maximum delivery rate, control and regulation parameters
• the automatic cavity detection can be confirmed by an optional confirmation from the user.
• FIG. 1 An example of this methodology is shown in FIG.
• Two volumes V 1 and V 2 are conveyed into the cavity at different times.
• the pressure in the cavity then rises to p c and the pressure of the cavity can be determined by means of a pressure sensor p d .
• an approximation of the PV diagram can then be calculated (see FIG. 4).
• the "settling" of the pressure measurement signal at the starting point and the stopping point of the volume flow can be clearly seen in the measurement diagram (FIGS. 5 to 7 below).
• method la is expanded as follows: A pressure control device is used to generate pressure in the cavity. In this case, the volume flow is specified which is necessary to achieve the desired pressure. In a closed cavity - without leakage - the pressure control would regulate the volume flow to zero when the desired pressure is reached (see FIG. 6).
• the pressure control would continuously track a volume flow in order to compensate for the leakage.
• This volume flow which is necessary to maintain the pressure, is the leakage volume flow q ⁇ at the existing cavity pressure. This is shown as an example in FIG. From this, the volume V 2 and V 3 , which flows out of the body cavity via the leak, can be determined. The introduced volume can then be cleared of the leakage.
• the pressure in the cavity p c1 at the point in time at which the volume flow is stopped can be determined or approximated by prior knowledge of the pressure drop across the connecting element and the measured pressure p d1,. At this point in time, p d ⁇ p c1 applies.
• the evaluation can be used as in method l.a.
• the target pressure can be increased (temporarily) in each case.
• the current working point can be determined in the PV diagram of the body cavity.
• a measurement pause is generated when the device is in operation.
• the volume flow is briefly interrupted and the steady-state cavity pressure p c1 is determined.
• a predefined temporal volume flow is then generated by means of the actuator (eg a pulse-shaped volume flow with a defined temporal length).
• the volume flow creates a pressure increase in the cavity.
• the volume V 2 supplied in this time segment can be determined by integrating the volume flow measuring unit.
• the device stops pumping after the defined volume flow and determines the static pressure in the cavity p c2 .
• the device then takes his normal functionality (see Figure 7).
• the plausibility can be compared to the presetting selected by the user and the actually determined characteristic values (see FIG. 8).
• the device can independently adjust the device parameter set in order to enable the user to optimally set the system to carry out the intervention.
• the pressure is temporarily increased when the device is in operation. Active pressure control / regulation is used for this.
• the additional volume required to obtain the desired pressure in the cavity is determined in the pressure increase phase.
• the procedure is to be equated with method II.
• method III can also be used in the initial filling phase of the cavity.
• the desired setpoint pressure of the pressure control is increased in a quasi-stationary manner (very slowly or in stages). A pause in measurement is not necessary if the system parameters are present for the device and the connection unit between the device and the body cavity.
• the data of the volume and the pressure generated can thus be transferred to a P-V diagram.
• this provides the basis for deriving the cavity size or indication. This results in the possibility of parameterizing and selecting optimal system parameters (e.g. max. Delivery rate, control and regulation parameters).
• the automatic cavity detection can be confirmed by an optional confirmation from the user.
• a variation of method II is that after determining the current cavity pressure p c1 , the volume flow is increased.
• the increasing pressure at the sensor correlates with the pressure increase in the cavity (see FIG. 9). It follows from this that a measurement of the cavity pressure p c2 becomes unnecessary (cf. method II). For this purpose (see FIG. 10) the increase Ap c based on the volume V 2 is determined. After the values have been determined, the device resumes its previous operation.
• Fluid reservoir (2) Fluidic connection (supply hose for the fluid between the reservoir and the medical technology

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Physics & Mathematics (AREA)
• Audiology, Speech & Language Pathology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Pathology (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Biophysics (AREA)
• Acoustics & Sound (AREA)
• Otolaryngology (AREA)
• Physiology (AREA)
• Multimedia (AREA)
• Cardiology (AREA)
• Vascular Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Surgical Instruments (AREA)
• Endoscopes (AREA)
• Medical Treatment And Welfare Office Work (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=76730248

Family Applications (1)

Country Status (6)

Family Cites Families (6)

• 2020
  • 2020-06-05 DE DE102020003419.5A patent/DE102020003419A1/de not_active Ceased
• 2021
  • 2021-06-07 JP JP2022574749A patent/JP2023528914A/ja active Pending
  • 2021-06-07 CN CN202180049083.1A patent/CN115811956A/zh active Pending
  • 2021-06-07 WO PCT/DE2021/000106 patent/WO2021244690A1/de active Application Filing
  • 2021-06-07 US US18/008,225 patent/US20230270954A1/en active Pending
  • 2021-06-07 EP EP21736507.1A patent/EP4161372A1/de active Pending

Also Published As

Similar Documents

Legal Events