Femoral compression system

The present invention relates to a femoral compression system (14) for applying compression against a puncture site of a vessel in a patient, and a method for applying compression with a femoral compression system. The compression system (14) comprises an inflatable compression element (15) adapted to apply a pressure against the puncture site, a tightening unit (23) adapted to extend around a part of, or the whole of, the patients body to fixate and to tighten the compression element (15) against the puncture site, a pump (16) adapted to inflate the compression element (15), a valve (17) adapted to deflate the compression element (15), a pressure transducer (18) adapted to sense the pressure within the compression element (15). The system further comprises a blood pressure pulse detector (19) adapted to sense the patient's blood pressure pulse and to generate a pulse signal in dependence thereto that is applied to a control unit (20) that is connected to the pump (16), valve (17) and pressure transducer (19), wherein the control unit (20) is adapted to control the pressure within the compression element (15) in dependence of the pulse signal, by applying control signals to said pump (16) and valve (17).

FIELD OF THE INVENTION

The present invention relates to a femoral compression system for compression of a vessel according to the preamble of the independent claims.

The present invention also relates to a method for applying compression of a vessel with the femoral compression system.

BACKGROUND OF THE INVENTION

To access a patient's vascular system for an invasive medical procedure such as catheterization or similar procedures, a puncture is made in e.g. the femoral artery. Following the medical procedure the flow of blood through the puncture site has to be stopped, so that haemostasis may begin as soon as possible. This may be done by using a compression device.

One example of such a compression device is known from WO 2009/000665, which is assigned to the same assignee as in the present application, describing a femoral compressing device for compressive bearing against the femoral artery of a patient. The device comprises a base plate, an inflatable air cushion, and a manometer connected to the inflatable air cushion. The device is fixed around the patient's body with a belt. In use, the inflatable air cushion is positioned over the femoral artery, and the belt is tightened and secured around the patient's body. To apply pressure to the femoral artery, the inflatable air cushion is inflated by a pump to a certain predetermined pressure, which is read from a pressure gauge.

When reducing the flow of blood passing a puncture site using a compression device a deficiency of blood supply to a part of the body, so called ischemia might occur. Thus, it would be desirable to be able to detect and register the patients pulse while stopping or reducing the blood flow passing the puncture site to lower the occurrency of ischemia.

Consequently, there is a need for an improved compression system for applying compression against a puncture site of a vessel in a patient, which minimizes the hospital resources needed and prevents unnecessary long procedures, and which system also helps to increase the patient integrity as the distance between the patient and health care professionals can be kept.

Further, there is a need for a system with a built-in control unit for controlling the pressure in the compression element when inflating or deflating.

SUMMARY OF THE INVENTION

The above-mentioned objects are achieved by the present invention according to the independent claim.

Preferred embodiments are set forth in the dependent claims.

Thus, according to the present invention a compression system comprising a pulse detector for automatically detecting the pulse is provided, which compression system regulates the pressure in the compression element, e.g. an inflatable air cushion, in dependence of the detected pulse.

The femoral compression system for applying compression against a puncture site of a vessel in a patient, in accordance with the present invention, comprises an inflatable compression element adapted to apply a pressure against the puncture site, a tightening unit adapted to extend around a part of, or the whole of, the patients body to fixate and to tighten the compression element against the puncture site, a pump adapted to inflate the compression element, a valve adapted to deflate the compression element, and a pressure transducer adapted to sense the pressure within the compression element. The system further comprises a blood pressure pulse detector adapted to sense the patient's blood pressure pulse and to generate a pulse signal in dependence thereto that is applied to a control unit that is connected to the pump, valve and pressure transducer, wherein the control unit is adapted to control the pressure within the compression element in dependence of the pulse signal, by applying control signals to the pump and valve.

Advantageously, the present invention in general, and in particular when applying a dedicated compression schedule, helps to optimize hemostasis, minimize the hospital resources needed, and prevent unnecessary long procedures, and increase the patient integrity.

FIG. 1illustrates a femoral compression device1, according to the prior art, and as described in WO 2009/000665. The device1comprises a base plate2with two extensions3aand3b, a compression element4, here in the shape of an inflatable and semi-spherical air cushion, a belt5, a pump6, an air connection7, and an electric pressure gauge or manometer8with display9. In use, compression element4is positioned over the femoral artery13of a patient12, and the belt5, which extends from the end of the first extension3a, around the patient's body12and to the end of the second extension3b, is tightened and secured by belt fasteners at the end of each extension. To apply pressure to the femoral artery13, the inflatable semi-spherical air cushion4is inflated by the pump6to a certain pressure, which is measured by the manometer8and displayed on the display9. The manometer8comprises further a vent knob10, which is covered by a cap11.

InFIG. 2, a femoral compression system14for applying compression against a puncture site of a vessel in a patient, according to the present invention, is disclosed. The femoral compression system14, comprises an inflatable compression element15adapted to apply a pressure against the puncture site, a tightening unit (not shown inFIG. 2) adapted to extend around a part of, or the whole of, the patients body to fixate and to tighten the compression element15against the puncture site, a pump16adapted to inflate the compression element15, a valve17adapted to deflate the compression element15, and a pressure transducer18adapted to sense the pressure within the compression element15.

As also illustrated inFIG. 2, the compression system14further comprises a blood pressure pulse detector19adapted to sense the patient's blood pressure pulse and to generate a pulse signal in dependence thereto that is applied to a control unit20that is connected to the pump16, valve17and pressure transducer18, wherein the control unit20is adapted to control the pressure within the compression element15in dependence of the pulse signal, by applying control signals to the pump and valve.

FIG. 3shows the compression element15, when in use. In a similar way as in the femoral compression device according to the prior art, shown inFIG. 1, the compression element15, here in the shape of an inflatable and semi-spherical air cushion, is positioned over the femoral artery24of a patient25, and the tightening unit23extends around the whole of the patient's body25. The compression element15is connected to the pump16, the valve17, and the pressure transducer18, and furthermore, a control unit20is connected to the pump16, valve17and pressure transducer18, and also to the pulse detector19.

Preferably, the pump is an electric air pump. The pump16and the valve17may be arranged as a separate unit or may be integrated in the control unit20. As an obvious constructive variation, the pump16and the valve17may be arranged as separate units, or may be arranged in the same unit.

FIG. 4illustrates the compression element15, in the shape of a semi-spherical air cushion, more in detail and seen from above, when positioned over a puncture site in the femoral artery of a patient's body.

According to the present invention, during startup of the compression system14the pulse detector19is activated to detect the patient's pulse. When the pulse is detected, the compression element15is inflated until the pulse is no longer detected by the pulse detector19. Thereafter, the compression element15is deflated until the pulse detector19detects the pulse again. In this way the compression of the puncture site will be well-balanced, and the pressure exerted by the compression element15will be neither to high nor to low. If the compression is to low bleeding may possible occur, and if the compression is to high there is a risk of ischemia, as discussed above. However, during startup of the system14, surveillance of the puncture site must be performed to identify possible bleeding.

The procedure may be fully or partly automated. According to one embodiment of the invention, the fully automated embodiment, the control unit20automatically controls the pump16and the valve17. According to this embodiment, after the pulse has been detected, the compression element15has been inflated, and the pulse no longer is detected by the pulse detector19, the control unit20is automatically, by means of the valve17, adapted to release the pressure within the compression element15according to a predetermined “compression schedule”. More specifically, the pressure transducer18senses the pressure within the compression element15and the control unit20is adapted to release the pressure according to a predetermined compression schedule stored in the control unit20.

A compression schedule includes parameters required to control the system, i.e. with regard to max/min thresholds of the detected pulse; control parameters, i.e. response times, max/min inflated pressure. Many different compression schedules may be stored, where each schedule is set up e.g. with regard to different patient types. These parameters are entered into the control unit20and stored in the control unit20, i.e in a compression schedule.

According to another embodiment of the present invention, the partly automated embodiment, the control unit20comprises an indicator unit22adapted to indicate to an operator when it is time to deflate the compression element15, as also shown inFIG. 5. In this embodiment, after the pulse has been detected, the compression element15has been inflated, and the pulse no longer is registrated by the pulse detector19, the indicator unit22indicates to the operator that it is time to deflate the compression element15. The operator may then manually, by means of the valve17, lower the pressure in the compression element15. Thus, the control unit20, or e.g. the pump16or the valve17may be provided with a display (not shown), which displays the actual pressure, sensed by the pressure transducer18, within the compression element15. The operator may then read the displayed pressure, and subsequently manually release an optional amount of the pressure, by means of the valve17.

The control unit20may be provided with + and − buttons, which the operator may press in order to increase or decrease the pressure within the compression element15. According to another embodiment, the control unit20may be provided with an “OK” button. When the operator presses the “OK” button, the control unit20sends a control signal to the valve17to lower the pressure to a predetermined subsequent pressure value.

Preferably, the control unit20is adapted to be able to be switched between the fully and partly automated states, in order to adapt the system14to the most suitable state in each specific case.

The pulse detector19is, according to the present invention, a pedal pulse detector, which is adapted to detect the pedal pulse. According to one embodiment of the present invention, the pulse detector19is arranged in relation to an inflatable cuff21. In use, when the blood pressure is about to be measured, the inflatable cuff21is put around the patient's ankle and inflated, before startup of the system14. Naturally, any other available pedal pulse detector type may be used, e.g. an optical, a piezoelectric or other type of electric pressure sensitive detector, or ultrasonic detector.

The control unit20of the system14is connected to the pulse detector19, the pressure transducer18and the pump16and valve17, via any standard signal interface, i.e. wireless, e.g. via Bluetooth, infrared signal, radio frequency signal, optical signal, or by wire.

The present invention also relates to a method for applying compression with a femoral compression system14, against a puncture site of a vessel in a patient. The method includes:a) providing an inflatable compression element15against said puncture site;b) tightening said compression element15against said puncture site by means of a tightening unit23extending around a part, or the whole of the patients body;c) detecting the patient's pulse by means of a pulse detector19;d) generating a pulse signal in dependence of the detected pulse, which pulse signal is applied to a control unit20;e) controlling the pressure within the compression element15, by means of said control unit20, in dependence of said pulse signal.

According to the method for applying compression with a femoral compression system14step e) may further include the steps of:e1) inflating said compression element15by means of a pump16until the pulse no longer is detected by said pulse detector19;e2) deflating said compression element15by means of a valve17until the pulse is detected by said pulse detector19again.

As discussed above, said control unit20may, by applying control signals to said pump16and valve17, control the pressure within the compression element15in accordance to one of many predetermined compression schedules.

Furthermore, and as also discussed above, said control unit20may indicate, by means of an indicator unit22, that the pulse no longer is detected by said pulse detector19, so that an operator manually may deflate said compression element15, by means of said valve17.

An example of a compression schedule is shown in the diagram inFIG. 6. According to this compression schedule, after the compression element15has been applied, the pressure within the compression element15is, by means of the pump16, increased until the pressure is 20 mmHg suprasystolic. At this pressure, no pedal pulse is detected. This pressure is kept for about 1-3 minutes, and thereafter the pressure is decreased until the pressure is approximately halfway between systolic and diastolic pressure. At this pressure it is checked that the pedal pulse is detected again. As shown inFIG. 6, the pressure is kept at this level for about 15 minutes. After that the pressure is decreased stepwise, e.g. first to a pressure approximately 20 mmHg below the diastolic pressure, and then yet another 20 mmHg, as also shown inFIG. 6. Finally, the pressure is kept at approximately 30 mmHg for about 60-180 minutes.