Patent Publication Number: US-2003229375-A1

Title: Device for establishing hemostasis of an open artery and/or vein of an extremity of a person

Description:
[0001] The present invention relates to a device for establishing hemostasis of an open artery and/or a vein of an extremity of a person through mechanically pressing an area of the extremity at the open artery and/or vein.  
       [0002] The present invention relates to a refined and novel technique for establishing hemostasis at a puncture site or a wound of a person through mechanically compressing the puncture site or wound. In specific surgical applications, the artery and/or the vein of a patient or person are opened for providing access to the blood circuit and/or for guiding blood from the artery system of the patient or person to an external apparatus, such as a dialysis apparatus and for guiding the blood back to the patient. After the dialysis treatment has been finalised or a similar treatment has been terminated involving the opening of arteries or veins of a patient, in particular at the extremity of a patient or person, such as at the wrist of the person, hemostasis is to be established before the patient or person is allowed to leave the hospital or left alone in a hospital. Conventionally, the establishing of hemostasis is established as a nurse presses his or her thumb to the site or area of the open artery and/or the open vein and maintains the pressure for a period of time of 15-30 minutes for establishing hemostasis. The manual process of pressing a finger, in particular the thumb, against the artery and/or the vein at the wrist of a person is for many reasons an unsatisfactory process, as the manual pressure application involves a waste of great many labour years in a hospital or a clinic and further, from a technical point of view, is far from constituting an optimum pressure application, as the nurse or other individual applying the manual pressure to the wrist of the patient or person, is unable to apply the correct pressure for an extended period of time. The risk of blood vessel occlusion and discomfort for the patient are therefore pronounced  
       [0003] A number of compressive appliances or hemostasis establishing devices have been developed for the use in the treatment of dialysis patients for establishing hemostatis of the open artery and the open vein used for the dialysis treatment and examples of these devices are the AccuGage™Vessel Caliper produced and supplied by the company Accumed Systems, Inc.; the product Easy Radial developed by Dr. M. Galli and manufactured and supplied by the company Blue Medical Devices; the product RadiStop™ Radial Compression System, produced and supplied by the company RadiMedical Systems AB; the product Radstat™ hemostasis device, developed by M. E. Arrowroot P.A.C., the product Hasin hemostasis device, developed by Professor Y. Hasin, the product Stepty®P hemostasis device, produced and supplied by the company Nichiban Corporation, Ltd, the product Adapty, a modification of Stepty®P hemostasis device, developed by Dr. Hideaki Sakai.  
       [0004] An object of the present invention is to provide an improved device as compared to the number of compressive appliances already known improving the mechanical compression technique by preventing congestion and ischemia by eliminating the risk of stasis and at the same time, releasing nurse time and improving the comfort for the patient.  
       [0005] A particular feature of the present invention relates to the application of the device, as the device may readily be applied providing the correct pressure to the area or the site at which compression is to be applied for establishing hemostasis.  
       [0006] A particular advantage obtained by the teachings of the present invention relates to the fact that the device according to the present invention for establishing hemostasis is of a low cost structure allowing the device, which is brought into contact with a patient or person, may be implemented as a disposable device, thereby preventing any risk of cross contamination.  
       [0007] The above object, the above advantage, the above feature together with numerous other objects, advantages and features which will be evident from the below disclosure of advantageous and preferred embodiments of the device according to the present invention are according to the present invention obtained by a device for establishing hemostasis of an open artery and/or a vein of an extremity of a person through mechanically compressing an area of said extremity at said open artery and/or vein, said device comprising: fa pair of elongated strips comprising a first strip and a second strip, said first strip being made of a first, flexible and bendable material and/or being configurated in a curved shape and defining a length exceeding the width of said extremity by a factor of no less than 1.5, said first strip defining opposite first and second ends, said second strip being made of a second, flexible and bendable material and defining a length exceeding the width of said extremity by a factor of no less than 1.5, said first strip being connected to or connectable to said second strip at said first end and said third end, respectively, through a hinge connection or through co-operating and interlocking connectors, said first strip being provided with a first connector element at said second end thereof and second strip being provided with a second connector element or a plurality of second connector elements at said fourth end thereof for co-operating with said first connector element of said first strip, and  
       [0008] a liquid absorbing pad arranged around the centre of said first strip or alternatively said second strip and for positioning at said area of said extremity at said open artery and/or vein and being supported relative to said first strip or alternatively said second strip by a compressible or flexible element including or co-operating with an indicator element for indicating the application of a specific pressure to said area of said extremity at said open artery and/or vein by said pad, and said first and second strips being positionable circumferentially encircling said extremity for applying said specific pressure to said area at said open artery end or vein by the adjustment of said locking between said first strip and said second strip through said first and second connector elements.  
       [0009] According to the basic teachings of the present invention, the device for establishing hemostasis includes a pair of strips which are in the intentional application of the device positioned circumferentially encircling the extremity, such as the wrist of a patient or person. The one strip presses the pad into contact with the application site, such as the wounds or the open artery and/or the open vein at the wrist of the patient or person and due to the presence of the indicator included in the device according to the present invention, the person applying the device readily adjusts the pressure applied to the application area or application site by adjusting the co-operating first and second connector elements and at the same time monitoring the pressure reading of the indicator.  
       [0010] As will be discussed in greater details below, the indicator may be implemented in numerous embodiments including any mechanical pressure indicator appliance including bending, stretching, compression registering or reading devices etc.  
       [0011] According to the presently preferred embodiment of the device according to the present invention, the first material of the first strip is identical to the material of the second strip allowing the two strips to be made from a single material, such as a plastics material, e.g. a skin compatible material, such as PE, PP, ABS or any other equivalent plastics material. The connection between the first and the second strips may be established through interlocking connectors, however, according to the presently preferred embodiment of the device according to the present invention, the connection between the first and the second strip is established by an integral hinge or a foil hinge of the strip material from which the first and the second strips are produced. Although plastics materials are presently contemplated to be preferred, different materials such as aluminium or any other corrosion resistant material may be used or used in combination with plastics materials, in particular for providing additional strength or specific mechanical support of one of the two strips or other components or elements of the device according to the present invention.  
       [0012] The locking elements by means of which the first and second strips be locked together circumferentially encircling the extremity of the person may be constituted by any locking fixtures, such as catches, burr or Velcro® fixtures, flexible bands to be tied round a pair of arresting pins or similar elements, however, according to a presently preferred embodiment of the device according to the present invention, the first locking element is constituted by a pin cut from the first strip and the second locking element or each of the plurality of the second locking elements are constituted by recesses or holes of the extension of the second strip.  
       [0013] The indication of the pressure applied by the pad at the application site such as the wound or open artery or open vein at the wrist of a patient or person may, as already stated, be provided by any indicator element capable of reading and displaying the compression or the pressure applied by the pad. According to a particular elegant and advantageous embodiment of the device according to the present invention, the compressible or flexible element is constituted by one or more additional pad elements supporting the liquid absorbing pad. By combining the indicator with the liquid absorbing pad in a pad assembly, a simple, lightweight and cheap structure is obtained providing a disposable device. The additional pad elements constituting the indicator may include a non-compressible pad and a compressible pad, may provide the indications through the reduction of the thickness of the compressible pad to a specific ratio, such as 50% of the thickness of the compressible pad in uncompressed state or alternatively through compression of the compressible pad to a thickness corresponding to the thickness of the non-compressible pad or the thickness of the liquid absorbing pad.  
       [0014] According to an alternative embodiment which may advantageously be implemented in embodiments in which the strips are cast or moulded, the indicator of the device according to the present invention constituted by the compressible or flexible element, is advantageously constituted by a spring element providing the indications through the positioning of an indicator, such as an end of the spring element relative to a pre-set marking.  
       [0015] An alternative embodiment of the device according to the present invention is provided by implementing the second strip as a flexible or bendable plastics band of a woven or non woven material which is readily tightened round the first connector element of the first strip while positioning the two strips circumferentially encircling the extremity of the patient or person in question.  
       [0016] As already mentioned above with reference to the discussion of the provision of the indicator as a spring element of a cast or moulded strip, the first strip may be pre-cast in a specific curved configuration and also cast with corrugations or with integral stiffening elements for ensuring that the first strip be kept in its intentional specific curved configuration.  
       [0017] Dependant on the actual application of the device according to the present invention for circumferentially encircling the wrist or alternatively the leg or any other extremity of a person, the length of the first and/or second strip as compared to the width of the extremity, may vary from the estimated lower limit of 1.5-5.0, such as between 1.5 and 2.0 or vary between 1.5 and 1.6, 1.6-1.7, 1.7-1.8, 1.8-1.9, 1.9-2.0, 2.0-2.5, 2.5-3.0, 3.0-3.5, 3.5-4.0, 4.0-5.0.  
       [0018] In order to prevent that the liquid absorbing pad, which is brought into contact with the application site, i.e. the wound and or the opening into the vein of the patient, is slipping on the skin surface of the patient or person, e.g. due to the presence of moisture or blood, the liquid absorbing pad is preferably covered by a perforated high frictional foil. 
     
    
    
     [0019] The present invention is now to be further described with reference to the drawings in which:  
     [0020]FIG. 1 is a perspective and schematic view of a first and presently preferred embodiment of a device according to the present invention for establishing hemostasis of an open artery or vein of an extremity such as the forearm or wrist of a person,  
     [0021]FIG. 1 a  is a perspective and schematic view similar to the view of FIG. 1 of a modified, two part form of the presently preferred embodiment of the device according to the present invention shown in FIG. 1,  
     [0022]FIG. 2 is a perspective and schematic view similar to the views of FIGS. 1 and 1 a  of a second embodiment of the device according to the present invention,  
     [0023]FIG. 3 is a perspective and schematic view similar~to the views of FIGS. 1 and 1 a  of a third embodiment of the device according to the present invention,  
     [0024]FIG. 4 is a perspective and schematic view similar to the views of FIGS. 1 and 1 a  of a fourth embodiment of the device according to the present invention,  
     [0025]FIG. 5 is a perspective and schematic view similar to the views of FIGS. 1 and 1 a  of a fifth embodiment of the device according to the present invention,  
     [0026]FIG. 6 is a perspective and schematic view of the application and intentional use of the third embodiment of the device according to the present invention also shown in FIG. 3 as the device is applied to the wrist or forearm of the person,  
     [0027]FIG. 7 is a perspective and schematic view similar to the view of FIG. 6 of the application and intentional views of the fourth embodiment of the device according to the present invention also shown in FIG. 4,  
     [0028]FIG. 8 is a vertical sectional view illustrating the application or intentional use of the second embodiment of the device according to the present invention also shown in FIG. 2,  
     [0029]FIG. 9 is a vertical sectional view similar to the view of FIG. 8 of a further modified embodiment of the device according to the present invention,  
     [0030]FIG. 10 is a partly sectional, perspective and schematic view of a compression applying pad assembly of the device according to the present invention,  
     [0031]FIGS. 11 a ,  11   b  and  11   c  are schematic views illustrating a particular feature of the pad assembly shown in the application and intentional use of the device according to the present invention for monitoring the application of a specific pressure to the compression site or area at the wrist or other extremity of a person.  
     [0032]FIGS. 12 a ,  12   b  and  12   c  are schematic views similar to the views of FIGS. 11 a ,  11   b  and  11   c  illustrating a different implementation of a monitor for monitoring the application of the specific pressure to the compression site or area,  
     [0033]FIG. 13 is a perspective and schematic view of a still further modified embodiment of the device according to the present invention including a further implementation of the monitor for monitoring the application of the specific pressure to the compression site or area at the wrist or other extremity of a person, and  
     [0034]FIGS. 14 a  and  14   b  are vertical sectional views of the embodiment shown in FIG. 13 and illustrating the monitoring of the application of the specific pressure to the compression site or area. 
    
    
     [0035] The present invention relates in general to a refined and novel technique of establishing a specific pressure at an area or a site of an extremity of a person or a mammal, which area or site includes an open artery or vein. The present invention relates in particular to a device for use in specific surgical circumstances, such as the treatment of an individual after the individual has been subjected to a dialysis treatment. In a dialysis treatment, the artery and the vein of the wrist of the individual or person of one of the arms of the individual or person in question are opened for allowing the staff operating the dialysis apparatus to direct the blood through the dialysis apparatus from the artery of the wrist of the person or individual to the artery of the person or individual. After the dialysis treatment has been finalised, the open artery and vein are to be compressed for establishing hemostasis before the person or individual is allowed to leave the dialysis clinic or hospital.  
     [0036] In FIG. 1, a first and presently preferred embodiment of the device according to the present invention is shown, designated the reference numeral  10  in its entirety. The device according to the present invention comprises a strip of a plastics material such as a strip of PE, PP or ABS or similar biologically acceptable plastics material or alternatively, aluminium or other non-corrosive metal materials. The strip  12  is punched or cast in a two-part configuration comprising two strips  14  and  16 . Each of these strips define opposite ends and are connected integrally to one another through a film, foil or integral hinge designated the reference numeral  18 . At a central position, the strip  14  is supporting a pad assembly  20  facing the strip  16  which assembly is to be described in greater details below with reference to FIGS. 10 and 11 a ,  11   b  and  11   c.    
     [0037] The strip  14  is at its end opposite to the end connected to the strip  16  through the film hinge  18  provided with two side recesses  30  and  32  and an end recess  34 . Similarly, the strip  16  is at its one end opposite to the end connected to the strip  14  through the hinge  18  provided with an extension in which nine pairs of side recesses are provided, one of the side recesses from the one side being designated the reference numeral  38  and a side recess at the opposite side of the extension  36  being designated the reference numeral  40 . The recesses  38  and  40  serve the purpose of allowing one of the recesses  32  or  34  to be received by the side recesses, such as the pair  38  and  40 , as the device  12  is applied to the wrist or other extremity of a person as is illustrated in FIGS. 6 and 7. The presence of nine pairs of recesses  38 ,  40  and the presence of two side recesses  32  and  34  of the strip  16  and the strip  14 , respectively, allows the device  10  to accommodate a wrist of a person, such as a child having a slim wrist and also a large wrist of e.g. a male.  
     [0038] In FIG. 1 a , a modified two-part form of the above-described presently preferred embodiment  10  shown in FIG. 1 is illustrated. In the various figures, components or elements identical to components or elements, respectively, described above, are designated the same reference numerals as used in a previous figure, whereas components or elements serving the same purpose as an element or component described with reference to a previous figure, is designated the same figure, however added a signature, i.e. a marking identifying the geometrical difference from the previously described component or element. In FIG. 1 a , the strips  14 ′ and  16 ′ differ from the strips  14  and  16  described above with reference to FIG. 1 in that the hinge  18  is omitted and the strip  14  is provided with an end recess  35  similar to the recess  34  provided at the opposite end of the strip  14  and in that the strip  16 ′ at its one end opposite to the extension  36  is provided with side recesses  39  and  41  serving the purpose of allowing the end recess  34  of the strip  14 ′ to be received for connecting the strips  14 ′ and  16 ′ together in a joint connection similar to a hinge connection.  
     [0039] In FIG. 2, a second embodiment of the device according to the present invention is shown designated the reference numeral  10 ″ in its entirety. The strip  12 ″ shown in FIG. 2 is of a pre-cast configuration differing from the above described first and the above described modified two-part form of the first embodiment in that the recess fixture of the strip  14  relative to the strip  16  by means of the co-operating recesses  32  and  34  of the strip  14  and the recesses  38  and  40  of the strip  16  are substituted by a pair of burr or Velcro® fixtures  32 ″ and  38 ″ provided at an extension  15  of the strip  12 ″ and the extension  36 ″ of the strip  16 ″.  
     [0040] In FIG. 3, a third embodiment of the device according to the present invention is shown designated the reference numeral  10 ′″ in its entirety. The device  10 ′″ differs from the above-described first embodiment  10  shown in FIG. 1 and the above-described embodiment  10 ″ shown in FIG. 2 in that the strip  16  is made from a woven material constituting a woven band or strip as distinct from the plastic foil strips  12  and  12 ″ of the devices  10  and  10 ″, respectively. In FIG. 3, the strip or band  16 ′″ is glued or otherwise adhered to the strip  14 ′″ by a turned-in part  17  fixated to the one end of the strip  14 ′″ opposite to the free end  15 ′″ to which the band  16 ′ is fixated after the strip or band has been threaded through one of the holes  32 ′″ or  34 ′″ as is shown in greater details in FIG. 6.  
     [0041] In FIG. 4, a fourth embodiment of the device according to the present invention is shown designated the reference numeral  10   iv  in its entirety. Like the above-described second embodiment  10 ″ shown in FIG. 2, the fourth embodiment  10   iv  shown in FIG. 4 is made from an integrally cast plastic component defining the integrally connected strips  14   iv  and  16   iv  which are connected through the integral hinge or film hinge  18   iv . The strip  14   iv  is, as is shown in FIG. 4, provided with corrugations  19  providing increased stiffness to the top strip  14   iv  as compared to the strip  16   iv  and at the same time configurates the strip  14   iv  in a specific curved shaped as is illustrated in FIG. 4. the outer end of the strip  14   iv  is provided with a recess  39  defining two upwardly turned lathes  41  serving the purposes of co-operating with the side recesses  38  and  40  of the extensions  36  of the strip  16   iv .  
     [0042] In FIG. 5, a fifth embodiment of the device according to the present invention is shown designated the reference numeral  10   v  in its entirety and differing from the above-described first embodiment  10  shown in FIG. 1 in that the recesses  32   v  and  34   v  are provided as mirror images of the recesses  32  and  34  shown in FIG. 1 and in that the end recess  39  is omitted. In the strip  16   v  which is pre-shaped into a bent configuration, the extension  36   v  of the strip  16   v  is provided with one row of recesses  40  and corresponding to the recesses  40 , a plurality of through-going holes  38   v  are provided serving the purpose of receiving one of the protruding pins  33   v  and  35   v  defined by the recesses  32   v  and  34   v , respectively.  
     [0043] In FIG. 6, the application or intentional use of the third embodiment  10 ′″ of the device according to the present invention is illustrated in greater details. In FIG. 6, the forearm  50  of a person is shown together with the hand  52  of the same person. At the wrist  54  of the person, the device  10 ′″ is applied. It is contemplated that the individual having the arm  50 , has previously been subjected to a treatment or alternatively an accident producing an opening into the artery and/or the vein at the wrist  54  of the forearm  50 .  
     [0044] An example of the usage of the device according to the present invention is the establishing of hemostasis in the openings into the artery and the vein of a person being treated in a dialysis apparatus in which case the artery and the vein of the person are opened for allowing the blood to be guided through the dialysis apparatus. After the dialysis treatment, the openings or wounds to the artery and the vein are to be closed and contrary to the manual pressing of the area around the artery opening and the vein opening together, as it has previously been practised in most clinics and hospitals, the device according to the present invention is readily usable for this purpose. According to a particular feature of the device according to the present invention, the strip  14  and also the strip  16  are fairly broad for ensuring that the only point of contact between the strip  14  and the forearm of the persons is at the pressure application site, i.e. at the site of contacting the pressure pad assembly  20  to the openings into the artery and/or the vein of the person. The strip  14  and similarly the strip  16  define a span exceeding the width of the wrist of the individual.  
     [0045] As is seen from FIG. 6, the device  10 ′″ apart from contact with the application site for applying pressure to the openings into the artery and the vein through the pad assembly  20 , the device only contacts the forearm at the opposite side of the forearm through the strip or band  16 .  
     [0046] According to a particular feature of the device implemented in accordance with the teachings of the present invention, the application of the device by a person, such as a nurse, is easily carried out and at the same time safely done while providing a specific pressure such as a pressure of the order of 300-400 g/cm 2  at the site of applying the pad assembly  20  as a component of a device, in particular the pad assembly includes an indicator informing the person applying the device to the forearm or the wrist  54  about the correct pressure applied to the application site through the pad  20 . This feature is to be discussed and described in greater details below with reference to FIGS.  11 - 14 . The fixation of the device  10 ′″ as shown in FIG. 6 is easily accomplished by simply twisting the strip or band  16  through the recesses and slits of the end parts  15 ′″ after the strip or band  16  has been threaded through one of the holes  32 ′″ and  34 ′″, in the application shown in FIG. 6 through the hole  32 ′″.  
     [0047] In FIG. 7, the application of the fourth embodiment  10   iv  shown in FIG. 4 is illustrated in a view similar to the view of FIG. 6. In FIG. 7, no detailed description of the extremity of the person is given as the only feature to be referred to in FIG. 7 relates to the possibility of adjusting the width and also the height of the device  10   iv  circumferentially encircling the wrist  54  by positioning the two lathes  41  in a specific pair of recesses  38 ,  40  of the extension  36  of the strip  16   iv  for providing the intentional application of a specific pressure by the pad assembly  20  to the open artery and/or vein for establishing hemostasis.  
     [0048] In FIG. 8, a vertical sectional view is shown illustrating a modified version  10   v  of the third embodiment  10 ′″ shown in FIGS.  3  and FIGS.  6  and differing from the third embodiment  10 ′″ in that the fixation of the strip or band  16 ′″ is provided through a burr or Velcro fixture of the strap  16 ′″ itself, i.e. a fixture similar to the fixture shown in FIG. 2.  
     [0049] In FIG. 9, a further variant of the device according to the present invention is shown designated the reference numeral  10   vi . The device  10   vi  shown in FIG. 9 differs from the above-described embodiments in that the strips  14  and  16  are combined into a single strap  12   vi  supported by the pressure applying pad assembly  20  and further three additional pads  21 ,  22  and  23  positioned in an orthogonal setup relative to the arm  50 . The pressure applying pad  20  is of the configuration to be described below for applying a specific predetermined pressure to the application site and the additional pads  21 ,  22  and  23  together with the strap  12   vi  which constitutes an elastic strap accommodate any excessive pressure provided the arm  50  is of a somewhat larger periphery than the normal size of the forearm to which the device  10   vi  is adapted, thereby establishing a multipad pressure system in combination with an elastic strap for establishing a specific pressure through the pad assembly to the application site for establishing hemostasis.  
     [0050] In FIG. 10, the pad assembly  20  is shown in greater details including a total of four layers and a perforated high frictional foil  60 , in which a plurality of holes or apertures  62  are provided. The foil  60  is of a skin compatible material such as siliconised polyester. Below the foil  60 , a liquid and blood absorbing pad  64  is provided made from a skin gentle material and also a highly absorbant material, such as a polyamide foam, preferably hemostatically impregnated. Furthermore, the pad  20  includes two parts  66  and  68  which in an alternative embodiment may be constituted by a single pad or configurated differently, as will be described below.  
     [0051] I the presently preferred embodiment, the pad  66  is a PU foam pad of a stiffness similar to the polyamide absorbing pad  64 . Below the PU foam pad  66 , a compressible pad made from a different PU foam material as compared to the foam material of the pad  66  is provided, which pad constitutes an indicator for informing the person applying the device according to present invention to the forearm of a patient or person about the pressure applied to the application site.  
     [0052] It has been realised that hemostasis is established by use of a contact area measuring 4 cm 2  provided a pressure of 300-400, preferably 350-400 g be applied to the 4 cm 2  contact area. Consequently, the pressure to be applied to the application site is preferably of the order of 90-100 g/cm 2 . For indicating to the person applying the device, the indicator pad  68  is adapted to be compressed to 50% of its initial height provided a pressure of 400 g/4 cm 2  equivalent to 100 g/cm 2  be applied to the assembly  20 . Consequently, as the person applying the device tightens the device round the wrist of the person as is illustrated generally in FIGS. 6 and 7, the person monitors the compression of the indicator pad  68  and tightens the device to such an extent that the pad  68  is compressed to 50% of its initial height, which reduction is easily perceived by the person applying the device.  
     [0053] In FIG. 10, the indicator pad  68  is illustrated in a dark colour which is contemplated to be advantageous for clearly indicating to the person applying the device that the dark coloured pad  68  constitutes the indicator pad which is to be monitored for monitoring the compression of the pad to 50% of its original height. In an alternative embodiment, the pad  66  and  68  are shifted and the indicator included in the pad assembly  20  is provided by the central pad as the indication is established by a compression of the indicator pad to a height identical to the height of the adjacent non-compressible pad.  
     [0054] Different configurations of the indicator system may of course be deduced based on the compression of a specific pad element, the compression of which is monitored in relation to its original height or in relation to an adjacent element constituting a measure of the intentional compression of the compressible indicator pad. In FIGS. 11 a ,  11   b  and  11   c , the pad assembly  20  is shown in greater details in an uncompressed state shown in FIG. 10 a . In FIG. 11 c , the indicator pad is compressed to 50% of its initial height shown in FIG. 11 a  and therefore, the pad assembly  20  is compressed to its intentional compressed state applying approximately 300-400 g/cm 2  equivalent to approximately 75-100 g/cm 2 . n FIG. 11 b . a differently configurated indicator system in which the central pad  66  constitutes the compressible pad, which as compared to the initial and uncompressed state shown in FIG. 11 a  is compressed to a height identical to the height of the indicator pad  68 .  
     [0055] In FIGS. 12 a - 12   c , a different indicator system is shown, which system includes a differently configurated pad assembly  20 ′ including the perforated high frictional foil  62 , the absorbing pad  64  and a single indicator pad  68 ′. The pad assembly  20 ′ shown in FIGS. 12 a - 12   c  is included within a circumferential housing or hidden behind a wall  69  constituting an integral part of the strip  14  and protrudes from the lower edge of the wall or the lower rim of the circumferential housing  69  in the uncompressed state shown in FIG. 12 a . As the device including the pad assembly  20 ′ is applied to the skin area or skin site of the person, e.g. as illustrated in FIGS. 6 and 7, the compressible indicator pad  68 ′ is compressed as shown in FIG. 12 b . At the time the boarder line between the liquid and blood absorbing pad  64  and the compressible indicator pad  68 ′ be hidden behind the wall  69  as shown in FIG. 12 c , the intentional pressure is provided at the application site of the order of 300-400 g/cm 2  equivalent to 70-100 g/cm 2 .  
     [0056] In FIG. 13, a further embodiment of the strip  14   vii  of a further embodiment  10   vii  of the device according to the present invention is shown. Whereas the pad assembly supporting strips  14 ,  14 ′,  14 ″,  14 ′″,  14   iv  and  14   v  are integral elements of a planar configuration or as shown in FIGS. 2 and 3 curved configuration, the embodiment shown in FIG. 13 includes a central spring element  70  depending from the curved strip  14   vii  and providing a support for the pad assembly  20   vii  which differs from the above-described pad  20  in that the pad assembly  20   vii  includes the liquid and blood absorbing pad  64 ′ covered by the perforated high frictional foil not shown in FIG. 13 and further, a support pad  66 ′ of a basical non-compressible PU material. The downwardly depending spring  70  is provided with a free outer edge  72  which is positioned juxtaposed the free edge  74  of a minor downwardly depending plate element  76 .  
     [0057] The edges  72  and  74  serve as indicators for informing the person applying the device  10   vii  to the forearm or the wrist of a person as is illustrated in FIGS. 6 and 7, as the edge  72  is in an unbiased or uncompressed state as shown in FIG. 14 a , positioned in spaced apart relationship relative to the edge  74 , whereas the edges  72  and  74  as shown in FIG. 14 b  are positioned closely adjacent one another provided the spring  70  is subjected to biasing force corresponding to the intentional pressure to be applied by the pad assembly  20   vii  to the application site, i.e. a pressure of the order of 75-100 g/cm 2 . Provided an excessive pressure be applied to the application site, the edge  72  is raised above the adjacent edge  74  indicating to the person applying the device  10   vii  that an excessive pressure is generated.  
     EXAMPLE  
     [0058] The presently preferred embodiment of the device according to the present invention shown in FIG. 1 was made from the following components: The strip  12  comprising the two strips  14  and  16  was made from PET of a thickness of 1.5 mm. The strip  14  had a length of 400.0 mm and a width of 22 mm and the strip including the extension  36  had a length of 238.2 mm. The hinge  18  was an integral film hinge. The pair of recesses  38  and  40  amounted to  9  as shown in FIG. 1 and the width of each of the recesses  38  and  40  was 5.0 mm and the depth of each of the recesses  38  and  40  was 6.5 mm. The end recess  39  of the strip  14  measured: depth 6.5 mm and width 5.0 mm. The side recesses  32  and  34  defined a lateral depth of 12 mm and a longitudinal extension of 12 mm. The width of the opening at the edge of the strip  14  defined by each of the recesses  32  and  34  measured 4 mm.  
     [0059] The pad assembly  20  was measuring length×width=4.84 cm 2  and a total height of 1.82 cm. The perforated high friction foil  60  was made from a PU foamed foil of a thickness of 0.2 mm and each of the apertures  62  had a diameter of 3.5 mm. The liquid absorbing pad  64  was made from hemostatically impregnated polyamide foam and defined a height of 3.5 mm. The non-compressible pad  66  was made from PU foam and defined a height of 9.0 mm. The compressible indicator pad  68  was made from PU foam and defined in its initial uncompressed state a height of 5.5 mm.  
     [0060] Although the present invention has been described above with reference to presently preferred embodiments, the invention is by no means limited to the above-described advantageous embodiments as the features described in the various embodiments are readily combinable with one another and further modifications or changes in the above-described embodiments, elements or components obvious to a person having ordinary skill in the art are to be considered part of the present invention as defined in the appending claims.