DEVICE FOR DETECTING HAEMATOMA OR SUBCUTANEOUS HAEMORRHAGE AFTER PERCUTANEOUS CORONARY INTERVENTION

• US 20100231377A1
• Filed: 02/23/2007
• Published: 09/16/2010
• Est. Priority Date: 02/24/2006
• Status: Active Grant

• Current Assignee: Cardialarm AS
• Original Assignee: Carsten Sandholdt
• Inventors: Sandholdt, Carsten
• Granted Patent: US 8,013,750 B2
• Time in Patent Office: Days
• US Class Current: 340/539.100
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A device for detecting a haematoma or subcutaneous haemorrhage after a PCI, which comprises a bandage provided with fastening means for its placement at the PCI access site, and the use of a safety bandage for producing the same. In the device, the bandage comprises a flexible and, in its longitudinal direction, non-elastic element connected to a strain sensor so arranged that the strain sensor, when the element after the placement of the bandage at the access site is subjected to a change in tension as a result of a haematoma or subcutaneous haemorrhage after the PCI, emits a signal that is indicative of the haematoma or haemorrhage.

Claims

1. A PCI entry site pressure bandage device or safety bandage device provided with fastening means for its placement at a PCI entry site,

characterised in

that the bandage device comprises a pressure bandage part and a detection means for detecting a haematoma or subcutaneous haemorrhage at the PCI entry site after a PCI.

2. A bandage device according to claim 1, wherein the detection means includes an elongate, bending flexible and, in its longitudinal direction, substantially non-elastic element, to which element there is fastened a strain sensor arranged so that it emits a signal that is indicative of the haematoma or haemorrhage when the element, after the placement of the bandage over the entry site, is subjected to an increase in tension as a result of the occurrence of the haematoma or other swelling from subcutaneous haemorrhage after the PCI.

3. A bandage device according to claim 2, wherein the compression bandage part and the elongate, bending-flexible and, in its longitudinal direction, substantially non-elastic element are formed of at least one uniform, bending flexible but, in its longitudinal direction, substantially non-elastic film, strip or band, formed of a solid material.

4. A bandage device according to claim 3, wherein the solid material is a plastic material, preferably transparent in an area that comprises or surrounds an area of the bandage device designated to be placed immediately over or immediately against the entry site.

5. A bandage device according to one of claims 3 or 4, wherein the film, strip or band has on opposite sides respective first and second surfaces,

the strain sensor is attached to the first surface, and

a friction means or an adhesive means with an exposable friction or adhesive surface is attached to the second surface.

6. A bandage device according to claim 5, wherein the exposable friction or adhesive surface is covered by a removable protection.

7. A bandage device according to claim 5 or 6, wherein the fastening means is constituted by an adhesive agent.

8. A bandage device according to claim 2, wherein the pressure bandage part consists of an elastic bandage, and

the elongate, bending flexible and, in its longitudinal direction, non-elastic element is formed of a bendable and, in its longitudinal direction, substantially non-elastic wire woven into the elastic bandage.

9. A bandage device according to claim 8, wherein the wire is a metal wire or spring metal wire.

10. A bandage device according to any one of claims 2, wherein the strain gauge is electronic.

11. A bandage device according to any one of the preceding claims, further comprising a transmitter device for connection to the strain sensor, and a processing means provided to process an electronic strain gauge signal.

12. A bandage device according to claim 11, wherein the processing means is provided to compute a plurality of first average values of the strain gauge signal over a first time period and to select a largest of the first average values as a threshold value for detection of haematoma or haemorrhage on the basis of measurement of a subsequent strain gauge signal.

13. A bandage device according to claim 12, wherein the processing means is provided to compute a plurality of second average values of the subsequent strain sensor signal over a second period of time and to select one of the second average values which exceed the threshold value as indication of haematoma or haemorrhage.

14. A bandage device according to claim 11, 12 or 13, further comprising a receiver device for connection to the transmitter device and comprising an alarm device for emitting an acoustic or optical alarm signal on the basis of a processed strain sensor signal emitted from the processing means.

15. A bandage device according to claim 14, wherein the acoustic signal is a high-frequency acoustic signal.

16. A bandage device according to any one of the preceding claims, wherein the detection device comprises or is constituted of an optical sensor, with or without optical transillumination and/or illumination of the skin, in order to be able to detect with optical means the haemorrhage in the surrounding tissue, or to be able to discover the haemorrhage possibly even before a swelling occurs to such an extent that it can be detected by a strain sensor.

17. A bandage device according to any one of the preceding claims, wherein the detection device comprises or is constituted of a temperature sensor for registering a change in temperature in connection with an extravasation of blood into the skin, or to be able to discover the haemorrhage possibly even before a swelling occurs to such an extent that it can be detected by a strain sensor.

18. A bandage device according to any one of the preceding claims, wherein the PCI pressure bandage is elongate, and

the fastening means comprises a hook and loop device or an elastic device, arranged at at least one end portion of the elongate PCI pressure bandage.

19. A bandage device according to any one of the preceding claims, wherein the PCI entry site is at the radial artery, i.e., about 5-7 cm from the wrist, or at the femoral artery, i.e., the main artery in the groin.

20. A production method, characterised in

that it comprises assembling a PCI entry site pressure bandage or safety bandage according to any one of the preceding claims for use in detecting and warning of a haematoma or subcutaneous haemorrhage after a PCI.

22. A production method according to claim 20 or 21, wherein the detection device comprises a strain sensor attached to an elongate, flexible and, in its longitudinal direction, substantially non-elastic element.

23. A production method according to claim 20, 21 or 22, wherein the detection device comprises an optical sensor, with or without optical transillumination and/or illumination of the skin, to be able to register with optical means the haemorrhage in the surrounding tissue, or comprises a temperature sensor for registering a change in temperature in connection with an extravasation of blood in the skin.

24. A production method according to claim 20, 21, 22 or 23, wherein the pressure bandage or safety bandage part is formed of an elastic bandage or at least one uniform, bending flexible, but in its longitudinal direction substantially non-elastic film, strip or band, formed of a solid material.

21. A production method, characterised in

that it comprises combining a PCI entry site pressure bandage part or safety bandage part and an electronic detection device to produce a device designed to both be able to be placed as a PCI entry site pressure bandage or safety bandage over a PCI entry site and to detect the occurrence of a haematoma or subcutaneous haemorrhage when the bandage is placed over the PCI entry site.