Gambro Lundia Ab

Syntach Ag

Kristian Solem

Bo Olde

Jan P Sternby

Thomas Hertz

Anders Wallenborg

Paolo Rovatti

Anders Nilsson

Mattias Holmer

Carlo Alberto Lodi

Alessandro Surace

Anders Wieslander

Per Hansson

Leif Sörnmo

Anders Roslund

Martin Furmanski

Daniel Engvall

Martin Wolff

Jan Otto Solem

Sture Hobro

David Stefani

Victoria Krüger

Leif Sömmo

André Spånberg

Jonathan Berg

An access device for a heart chamber, a removable hemostatic valve unit, and a system and a method of creating a transapical passage on a beating heart are disclosed. In examples, the access device () includes an apical base plate () and a sealing unit () configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.

Access device for a heart, a removable hemostatic valve unit, and a system and a method of creating a transapical passage on a beating heart

A monitoring system performs a method for detecting a disruption of a fluid connection between a first fluid containing system and a second fluid containing system. The monitoring system generates a monitoring signal which is representative of a fluid pressure in respect of the first fluid containing system and which is responsive to the disruption of the fluid connection, and a tracking signal which corresponds to and is more smoothed over time than the monitoring signal. The monitoring system further sets a detection range in a given relation to the tracking signal so that the detection range follows changes in the tracking signal, and detects a condition indicative of the disruption by comparing a current pressure value of the monitoring signal to the detection range. The monitoring system may be connected to or part of an apparatus for blood treatment and operable to detect a disconnection of an extracorporeal blood circuit from a vascular system of a patient, e.g. downstream of a blood pump in the extracorporeal blood circuit.

Detection of a disruption of a fluid connection between two fluid containing systems

An extracorporeal blood treatment apparatus includes a filtration unit () connected to a blood circuit () and a dialysate circuit (), a preparation device () for preparing and regulating the composition of the dialysis fluid, and a sensor () for measuring conductivity of the dialysate (i.e. spent dialysis fluid); a control unit () configured for setting a sodium concentration in the dialysis fluid and after setting the dialysis fluid at the initial set point, circulating the dialysis fluid and blood through the filtration unit (), measuring an initial conductivity value of the dialysate at the beginning of the treatment, and calculating, based on the measured initial conductivity value and on the corresponding conductivity value of the dialysis fluid, the value of the initial plasma conductivity, said circulating of the dialysis fluid up to the calculating of the initial plasma conductivity performed by maintaining the dialysis fluid conductivity substantially constant.

Apparatus for extracorporeal blood treatment

An extracorporeal blood treatment apparatus is provided comprising a filtration unit () connected to a blood circuit () and to a dialysate circuit (), a preparation device () for preparing and regulating the composition of the dialysis fluid, and a sensor () for measuring conductivity of the dialysate (i.e. spent dialysis fluid); a control unit () configured for setting a sodium concentration in the dialysis fluid and after setting the dialysis fluid at the initial set point, circulating the dialysis fluid and/or the substitution fluid, measuring an initial conductivity value of the dialysate at the beginning of the treatment, and calculating, based on the measured initial conductivity value of the spent dialysis fluid and on the corresponding conductivity value of the dialysis fluid, the value of the initial plasma conductivity, said circulating the dialysis fluid up to the calculating of the initial plasma conductivity being performed maintaining the dialysis fluid conductivity substantially constant.

An extracorporeal blood treatment apparatus is provided comprising a filtration unit () connected to a blood circuit () and to a dialysate circuit (), a preparation device () for preparing and regulating the composition of the dialysis fluid; a control unit () is configured for setting a sodium concentration value for the dialysis fluid in the dialysis supply line () at a set point; the setting of the sodium concentration includes the sub-step of calculating the sodium concentration value as an algebraic sum of a main contribution term based on the blood plasma conductivity and of an adjustment contribution term based on a concentration of at least a substance in the dialysis fluid chosen in the group including bicarbonate, potassium, acetate, lactate, citrate, magnesium, calcium, sulphate, and phosphate.

A method of monitoring the integrity of a fluid connection between first and second fluid containing systems based on at least one time-dependent measurement signal from a pressure sensor in the first fluid containing system. The pressure sensor detects first pulses originating from a first pulse generator in the first fluid containing system and second pulses originating from a second pulse generator in the second fluid containing system. A parameter value representing a distribution of signal values within a time window is calculated by analyzing the measurement signal in the time domain and/or by using information on the timing of the second pulses in the measurement signal. The parameter value may be calculated as a statistical dispersion measure of the signal values, or from matching the signal to a predicted temporal signal profile of the second pulse. The integrity of the fluid connection is determined from the parameter value.

Methods and devices for monitoring the integrity of a fluid connection

A monitoring arrangementis configured to predict a rapid symptomatic drop in a subject's blood pressure, e.g. during a medical treatment or when operating aircraft. To this aim, a pulse shape parameter (p) with respect to a peripheral body part () of the subject (P) is repeatedly registered by means of a pulse oximetry instrument () adapted to detect light response variations in blood vessels. A respective pulse magnitude measure is calculated based on each of a number of received pulse shape parameters (p), and a statistical dispersion measure is calculated based on the thus-calculated pulse magnitude measure. It is investigated whether or not the statistical dispersion measure fulfils a decision criterion relative to a reference measure. An output signal (&#x3b1;) is generated if the decision criterion is found to be fulfilled.

Apparatus and method for prediction of rapid symptomatic blood pressure decrease

A filtering device receives a pressure signal (P) from a pressure sensor in a fluid containing system, the pressure signal (P) comprising first pulses originating from a first periodic pulse generator and second pulses. The device acquires a reference signal which is indicative of a current operating frequency of the first periodic pulse generator. The device identifies, based on the reference signal, a plurality of harmonics (-) associated with the current operating frequency, computes correlation values (&#x3bb;-&#x3bb;) between the harmonics and the pressure signal (P) within a time window in the pressure signal (P), and generates a filtered signal by subtracting, as a function of the correlation values (&#x3bb;-&#x3bb;), the harmonics from the pressure signal (P). The use of correlation values is a direct, fast, robust and computation-efficient approach for estimating the signal contribution (d) from first pulses in the pressure signal (P).

Filtering of pressure signals for suppression of periodic pulses

A monitoring system () performs a method for detecting a disruption of a fluid connection between a first fluid containing system and a second fluid containing system. The monitoring system generates a monitoring signal (M) which is representative of a fluid pressure in respect of the first fluid containing system and which is responsive to the disruption of the fluid connection, and a tracking signal (T) which corresponds to and is more smoothed over time than the monitoring signal (M). The monitoring system () further sets a detection range (ML, MH) in a given relation to the tracking signal (T) so that the detection range (ML, MH) follows changes in the tracking signal (T), and detects a condition indicative of the disruption by comparing a current pressure value of the monitoring signal (M) to the detection range (ML, MH). The monitoring system () may be connected to or part of an apparatus for blood treatment and operable to detect a disconnection of an extracorporeal blood circuit from a vascular system of a patient, e.g. downstream of a blood pump in the extracorporeal blood circuit.

A monitoring device is included in a medical system to implement a method for prediction of a rapid symptomatic drop in a subject's blood pressure, e.g. during a medical treatment such as dialysis. To this aim, a pulse shape parameter (pPS) with respect to a pulse generator of the subject is registered by means of a pressure sensor arranged in an extracorporeal blood flow circuit coupled to a cardiovascular system of the subject (P). The pressure sensor is configured to detect pressure variations in blood vessels of the subject (P). It is investigated, during measurement period, whether or not one or more of the pulse shape parameters fulfil a decision criterion. An output signal (a) is generated if the decision criterion is found to be fulfilled, to indicate a predicted rapid symptomatic blood pressure decrease in the subject (P). The decision criterion may operate on pulse magnitude measures calculated for the received pulse shape parameters (pPS), or statistical dispersion measures calculated based on the thus-calculated pulse magnitude measures.

An implantable medical device is disclosed including an anchor unit configured to be permanently anchored at a cardiac valve of a patient, at least one locking unit, such as for fixation of tissue of the cardiac valve and/or fixation of at least a part of a shape of the anchor unit, and at least one coupling unit for connecting the anchor unit to at least one of the locking unit. The coupling unit has a first end portion and a second end portion, wherein the first end portion is connectable to the anchor unit, and the second end portion includes the locking unit.

Implantable cardiac valve improvement device, system and procedure

A monitoring device operates on a pressure signal from a blood processing apparatus which has an extracorporeal blood circuit for pumping blood through a dialyzer, and a treatment fluid supply system for pumping a treatment fluid through the dialyzer. The monitoring device has a first input block for obtaining a first pressure signal, and a second input block for obtaining a second pressure signal. An emulation block generates, as a function of the second pressure signal, an emulated first pressure signal which emulates a concurrent signal response of the first pressure sensor, and a filtering block generates a filtered signal as a function of the first pressure signal and the emulated first pressure signal, so as to suppress, in the filtered signal compared to the first pressure signal, signal interferences originating from the treatment fluid supply system. A pulse detection block processes the filtered signal for detection of subject pulses.

Detecting pressure pulses in a blood processing apparatus

An extracorporeal blood treatment apparatus is provided comprising a filtration unit () connected to a blood circuit () and to a dialysate circuit (), a preparation device () for preparing and regulating the composition of the dialysis fluid, and a sensor () for measuring conductivity of the dialysate (i.e. spent dialysis fluid); a control unit () configured for setting a sodium concentration in the dialysis fluid and after setting the dialysis fluid at the initial set point, circulating the dialysis fluid and blood through the filtration unit (), measuring an initial conductivity value of the dialysate at the beginning of the treatment, and calculating, based on the measured initial conductivity value of the spent dialysis fluid and on the corresponding conductivity value of the dialysis fluid, the value of the initial plasma conductivity, said circulating the dialysis fluid up to the calculating of the initial plasma conductivity being performed maintaining the dialysis fluid conductivity substantially constant.

A monitoring device detects a disruption of a fluid connection between first and second fluid containing systems using one or more pressure sensors arranged in the first fluid containing system to detect first pulses from the first fluid containing system and second pulses from the second fluid containing system. The monitoring device receives () pressure signal(s) from the pressure sensor(s), populates () signal vectors by signal segments in the pressure signal(s) and computes () one or more eigenvectors and/or one or more eigenvalues for the signal vectors by a source separation algorithm. The monitoring device detects () the disruption based on a monitoring parameter, which is computed as a function of the eigenvector(s) and/or eigenvalue(s) to be responsive to the second pulses in the pressure signal(s). The monitoring device may be associated with or included in an apparatus for extracorporeal blood processing, such as a dialysis machine.

Device and method for disruption detection

A control system () is arranged to control the operation of an apparatus () for extracorporeal blood treatment. The apparatus () comprises an extracorporeal blood circuit () and a connection system (C) for connecting the blood circuit () to the vascular system of a patient. The blood circuit () comprises a blood processing device (), and at least one pumping device (). The control system is operable to switch between a pre-treatment mode and a blood treatment mode. The blood treatment mode involves operating the blood circuit () to pump blood from the vascular system via the connection system (C) through the blood processing device () and back to the vascular system via the connection system (C). The control system () is operable to obtain measurement data from at least one energy transfer sensor () arranged to sense a transfer of energy between the patient and the connection system (C) or between the patient and the blood circuit (). The control system () is configured to, in the pre-treatment mode, process the measurement data for identification of a characteristic change indicating a connection of the blood circuit () to the vascular system of the patient, and, upon such identification, take dedicated action. The action may involve activating at least part of a patient protection system and/or enabling entry into the blood treatment mode. The control system may be included in an apparatus () for blood treatment, such as a dialysis machine.

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Kavlinge, Sweden

Kristian Solem