FEMORAL COMPRESSION DEVICE FOR POST-CATHETERIZATION

Abstract: A femoral arterial or venous compression device for post-catheterization hemostasis comprised of a supporting frame (base (1), shaft (2) and arm (4)) as shown in the figure, and an inflatable unit (carriage (6), bellows (7), disk (8) and pad (9)). The supporting frame is fixed on the human body in line with the incision site in order to bring the pad (9) exactly over and in touch with the latter. The bellows (7) are inflated thus compressing the incision site with the pad (9) for all the time needed to reach complete hemostasis. The pressure on the incision site remains constant during the compression period and can be regulated and monitored using a medical sfigmomanometer.

Description: Description Femoral Compression Device For Post-Catheterization Technical Field The invention relates to a femoral arterial or venous compression device for post-catheterization hemostasis comprised pf a supporting frame, for fixing on the human body, carrying an inflatable unit which ends with a pad. Femoral compression (compression of an incision site on the femoral artery or vein) is a step usually performed following angioplasty where enlarging the lumen of stenotic arteries takes place, thereby improving distal flow. In PTCA (Percutaneous Transluminal Coronary Angioplasty), inserting catheters via the percutaneous femoral approach is -widely used to reach stenoses. Clearly, when the catheters are withdrawn from the femoral artery after the end of angioplasty procedure, the incision site must be tamponed for hemostasis. Due to the wide diameter of the femoral artery and to the anti¬ coagulant solution usually used in the blood during such procedures, hemostasis can only be reached applying constant pressure on the incision site for relatively long time. Background Art The most practiced way is the manual one where an operator applies this pressure using a normal tampon, obviously, it is a waste of time for the personnel as complete hemostasis can only be reached after several minutes, furthermore, the pressure practiced manually is never constant. Disclosure of the Invention The invention as claimed is intended to remedy these drawbacks. It offers a simple method for applying constant pressure on the incision site of the femoral artery or vein occupying few minutes of the personnel time. The advantages offered by the invention is mainly that once the device is fixed on the human body, it maintains its position for all the time needed to reach hemostasis applying a constant pressure on the incision site thus stanching completely any blood flow or fluid leakage Furthermore, the pressure applied can be regulated and monitored using a normal sfigmomanometer Another important advantage of the device is that, during its application on the human body, the operator has a clear view of the incision site which permits an exact and effective positioning Brief Description of Drawings The main parts of the device are described below with reference to the following drawings fig 1 is a side view on a reduced scale of the device when assembled, fig 2 is a plan on a real scale Fig 1 shows the femoral compression device comprising a horizontal base (1 ) on which a tubular shaft (2) is fixed vertically via fastening means (3) (e.g pin or screw) The top of the shaft is blanked using a plug (11 ) An arm (4) can slide vertically along the shaft (2), furthermore, it can rotate in a horizontal plane, as shown in fig 2 The arm (4) is locked in its position using a knob (5) Along this arm (4), a circular carriage (6) can slide horizontally, as shown in fig 1 , carrying cylindrical bellows (7) The carriage (6) is provided on its top with a standard connection (12), as shown in fig. 2, for connecting a medical sfigmomanometer. On the other side of the bellows (7) a circular disk (8) is fixed carrying, on its lower side, a pad (9) with a spherical segment shape The carnage (6) and the disk (8) are attached to the bellows (7) using circular rings (10) as shown in fig. 1 The arm (4), the carnage (6), The bellows (7), the disk (8), the rings (10) and the pad (9) are made of transparent material to allow the operator to have a clear view of the incision site, this permits an exact and effective positioning of the pad (9) Best Mode for Carrying out the Invention The device is fixed on the human body in the following way the base (1 ) is inserted under the hip (right or left) in such a position that the vertical shaft (2) touches the external side of the hip almost in line with the incision site Subsequently, the positions of both the arm (4) and the carriage (6) are regulated vertically and horizontally, respectively, in order to bring the pad (9) exactly over and in touch with the incision site The position reached is maintained by locking the knob (5) After the positioning procedure, the bellows (7) are inflated via the connection (12) using a medical sfigmomanometer thus compressing the incision site with the pad (9) Once the necessary pressure for stanching the blood flow is reached, the device can be left in its position for the time needed to reach complete hemostasis

Claims: Claims 1 A femoral arterial or venous compression device for post-catheteπzation hemostasis comprised of base (1 ) on which a tubular shaft (2) is fixed vertically via fastening means (3) An arm (4) can slide vertically along the shaft (2), furthermore, it can rotate in a horizontal plane, as shown in fig 2 The arm (4) is locked in its position using a knob (5). A carriage (6) provided on its top with a standard connection (12), for connecting a medical sfigmomanometer, can slide horizontally along the arm (4) carrying cylindrical bellows (7) on which a circular disk (8) is fixed On its lower side, a pad (9) with a spherical segment shape is fixed The bellows (7) are attached to the carriage (6) and the disk (8) using circular rings (10) 2 The use of a structure as claimed in claim (1 ) for the compression of the incision site of the femoral artery or vein which acts as an entry to catheters for coronary angioplasty

Inventors: CAFUERI EMILIANO, KLUGMANN SILVIO, SHEHATA NADER, CAFUERI, EMILIANO, KLUGMANN, SILVIO, SHEHATA, NADER
Applicants: CAFUERI EMILIANO, I B S S R L, KLUGMANN SILVIO, SHEHATA NADER, CAFUERI, EMILIANO, I.B.S. S.R.L., KLUGMANN, SILVIO, SHEHATA, NADER
Application year: 1995
Main classification: A61B17
IPC codes: A61B17