Abstract:
The invention relates to a device capable of stopping the bleeding caused by the withdrawal of an injector stuck into an injection area of a patient. The device comprises: a base; a supporting means capable of temporarily attaching the base to the patient; an applicator supported by the base and provided with a transparent pad; and a screw-and-nut adjustment means capable of moving the applicator toward the injection area so that the applicator moves to a position where the pad exerts pressure on the injection area. The screw-and-nut system is located completely outside the diameter of the transparent pad. The invention can be used for angiography and angioplasty operations.

Description:
[0001]    The present invention relates to a compressive hemostatic device of the type described in the preamble of claim  1 . This device is in particular adapted to perform the hemostasis of the radial artery for example following an angiography or angioplasty operation without hindering the venous return and without compressing the ulnar artery. 
         [0002]    Certain medical imaging methods require a medical operation consisting of injecting a radiological contrast product into the patient&#39;s blood system. The contrast is injected through catheters that are passed into an injector emerging in a blood vessel, the injector ensuring the sealing of the assembly. For example, the injector is placed on the inner surface of the patient&#39;s wrist so as to allow the injection of the liquid via the radial artery. Once the operation is completed, removing the injector while limiting bleeding requires the application of sufficient pressure at the point where the puncture was done, in a zone called injection or puncture zone. The compression is reduced gradually, until hemostasis of the concerned blood vessel, which can take several hours. 
         [0003]    Several devices can be used to obtain such a pressure on the injection area. For example, document GB 08900 discloses a hemostatic device of the aforementioned type. Practitioners also use devices made up of bandages gripping the injection area. The device according to GB 08900 and these devices made up of bandages do not allow optimal positioning on the injection area, due to their opaque nature, or a reliable assessment of the pressure exerted. However, these parameters are fundamentally decisive in the effectiveness of such a device. 
         [0004]    Other devices exist, for example of the “TR-BAND®” type by the company TERUMO, assuming the form of a translucent bracelet comprising inflatable pads. The bracelet is positioned around the patient&#39;s wrist on the injection area. A syringe is then used to inflate the pads, which exert pressure on the injection area. This type of device therefore comprises several elements, which makes caregiver manipulations more complex. Furthermore, these devices also do not allow a reliable and simple assessment of the pressure exerted during placement of the device, or the decompression stop(s). 
       SUMMARY 
       [0005]    The invention aims to propose an autonomous device that can be placed and manipulated by a single operator, at any time, simply and reliably. 
         [0006]    Furthermore, in order to best manage the hemostasis, the caregiver must efficiently and reliably monitor the actual decompression time of the patient&#39;s injection area. In fact, not only is it desirable to know the total compression time at all times so that the caregiver can assess the relevance of removing the hemostatic device, but it is also recommended to perform the decompression step in levels. 
         [0007]    The devices known to date do not have any particular means making it possible to effectively save the placement time. At the very most, it is possible to write the placement time with a simple pen on the device itself or on the treated area on the patient. The risks of erasure are very real, however, and the caregiver must calculate the removal time unassisted, which can cause harmful calculation errors. Furthermore, monitoring times for several decompression stops can prove particularly difficult, since the aforementioned problems are multiplied by monitoring several patients, and the limited space ends up making the operation too complex. 
         [0008]    The invention also aims to propose a time device enabling simple and reliable monitoring of the total placement time of the medical device and/or the length of intermediate steps performed using said medical device, the time device being able in particular to be used on or with a hemostatic device as mentioned above. 
         [0009]    To that end, the present invention relates to a compressive hemostatic device of the aforementioned type. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    Other features and advantages of the present invention will better appear upon reading the following description of one embodiment provided as an illustration and non-limitingly in the appended Figures, which show: 
           [0011]      FIG. 1 , an overall perspective view of a compressive hemostatic device according to a first embodiment of the invention; 
           [0012]      FIGS. 2   a  and  2   b , front and side views of the base of the compressive hemostatic device according to the first embodiment; 
           [0013]      FIGS. 3   a  and  3   b , side and axial cross-sectional views of the applicator of the compressive hemostatic device according to the first embodiment; 
           [0014]      FIGS. 3   c  and  3   d , a planar view and an axial cross-sectional view along line IIId-IIId of  FIG. 3   c , respectively, of one applicator alternative; 
           [0015]      FIG. 4   a , a lateral cross-section of the compressive hemostatic device according to the first embodiment; 
           [0016]      FIG. 4   b , an axial cross-sectional view of the button of the compressive hemostatic device according to the first embodiment; 
           [0017]      FIG. 5 , a frontal view of a bracelet according to the first embodiment; 
           [0018]      FIGS. 6   a ,  6   b ,  6   c , a lateral cross-section, a side view and a front view of the compressive hemostatic device according to a second embodiment of the invention; 
           [0019]      FIGS. 7   a ,  7   b ,  7   c , two lateral cross-sectional views and a front view of the means for saving the placement and removal times according to a first embodiment; 
           [0020]      FIGS. 8   a ,  8   b , a lateral cross-sectional view and a front view of the means for storing placement and removal times according to a second embodiment; 
           [0021]      FIG. 9 , an exploded view of the compressive hemostatic device according to a third embodiment of the invention, the transparent pad not being shown; 
           [0022]      FIG. 10 , a perspective view of an anti-reverse latch of the device of  FIG. 9 ; 
           [0023]      FIG. 11 , a top view of the device of  FIG. 9 ; 
           [0024]      FIG. 12 , a perspective view of the anti-reverse latch of  FIG. 10  positioned on the base of the device of  FIG. 9 ; 
           [0025]      FIG. 13 , an axial cross-section of the button of the device of  FIG. 9  with the anti-reverse latch of  FIG. 10  in the locking position; 
           [0026]      FIG. 14 , an axial cross-section similar to that of  FIG. 13 , but with the anti-reverse latch in the unlocking position. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    The compressive hemostatic device according to a first embodiment illustrated in  FIG. 1  comprises a base  10  on which an applicator  12  is mounted, one of the ends of the latter part comprising a pad  14 . A bracelet  16  is fastened on the base  10  making it possible to temporarily secure the base  10  to the patient. The device also comprises a rotary button  18  mounted on the base  10  and cooperating with the applicator  12  so as to translate the latter toward the injection or puncture zone and vice versa. 
         [0028]    The base  10 , as shown in  FIGS. 2   a  and  2   b , is formed by a planar part  10   a  extended by a part  10   b  curved in an arc of circle. The general shape and the dimensions of the base  10  are chosen so that the base  10  can be positioned ergonomically around the injection area on the patient&#39;s wrist. The base  10  is passed through by a substantially circular recess forming a sighting hole  20 , the center of which is situated at the middle of the segment forming the border between the planar part  10   a  and the curved part  10   b.    
         [0029]    The sighting hole  20  forms the base of a substantially cylindrical flange  22 . The axis X-X of the flange  22 , assumed to be vertical for the purposes of this description, is perpendicular to the planar part  10   a  of the base  10 . Three linear guideways  23  extend axially along the entire inner surface of the flange  22 . The guideways  23  are equidistant two by two. 
         [0030]    Alternatively, one of the guideways can be slightly different or offset so as to index the applicator on the base. 
         [0031]    Through holes  24  are formed at the base and around the flange  22  and extend in the adjacent part of the base  10 . The through holes  24  are distributed uniformly on the entire periphery of the flange  22 . The flange  22  extends in the through holes  24  in assembly clips  26 . The assembly clips  26  extend parallel to the axis X-X. Each assembly clip  26  comprises a protrusion  27  at its distal end oriented toward the outside of the flange  22 . Each protrusion  27  protrudes relative to the outer surface of the flange  22 . 
         [0032]    The base  10  comprises, in its curved part  10   b  and on the periphery of the flange  22 , radial stiffening and support ribs  28  for the adjustment button. The ribs  28  rise to the height of the planar part  10   a . The planar upper face of the radial ribs  28  is comprised in the same plane as that of the planar part  10   a  of the base  10 . 
         [0033]    The base  10  comprises, overlapping the segment forming the border between the planar part  10   a  and the curved part  10   b , two diametrically opposite supports  30  relative to the axis X-X. Each support  30  rises vertically. The side faces of each support  30  form an arc of circle centered on the axis X-X. Each support  30  is elastically deformable and comprises, on its inner side face, a gadroon or pawl protrusion  32 . 
         [0034]    The curved part  10   b  of the base  10  comprises a hollow semi-cylindrical extension  34  with longitudinal axis X-X. The extension  34  rises to the height of the plane of the planar part  10   a . The extension  34  has a diameter substantially equal to the length of the segment forming the border between the planar part  10   a  and the curved part  10   b.    
         [0035]    The base  10  comprises, at the end of its curved portion  10   b , a fastening lug  36 . The base  10  comprises, at the end of its planar portion  10   a , an extension  10   c  supporting two hooks  38 . 
         [0036]    As illustrated in  FIGS. 3   a  and  3   b , the applicator  12  comprises a support  50 . The support  50  is formed by a cylindrical inner tube  50   a  with an outer diameter d 1  and a cylindrical outer tube  50   b  with an inner diameter d 2 . The two tubes  50   a  and  50   b  are coaxial and connected by their bases. The outer diameter d 1  is chosen so as to be substantially equal to the inner diameter of the flange  22  of the base  10 . The inner diameter d 2  is chosen so as to be substantially equal to the outer diameter of the flange  22 . The lengths of the tube  50   a  and the tube  50   b  are chosen as a function of the desired movement amplitude for the applicator  12  when the button  18  is actuated. 
         [0037]    The tube  50   a  comprises three recesses  52   a  extending longitudinally in the outer face of the first tube  50   a . The recesses  52   a  are sized and positioned so as to cooperate with the guideways  23  of the flange  22  of the base  10  when the support  50  is mounted in the flange  22 . The tube  50   a  comprises an inner flange  54   a  at its free end cooperating with a circular recess formed in the pad  14  so as to secure the latter part to the support  50 . The outer face of the tube  50   b  comprises a protruding screw thread  56   b.    
         [0038]    Alternatively, the tube  50   b  can have two threads “fitted” one into the other to reliabilize the screwing and distribute the tightening forces. 
         [0039]    The pad  14  is made from a transparent material. The spherical dome bearing shape of the pad  14  is chosen so as to maximize the patient&#39;s comfort while reducing the risk of blocking the venous return on the other veins located nearby. 
         [0040]    Alternatively, the bearing shape of the pad can be different from a spherical dome, in particular oblong and particularly semi-cylindrical, as shown in  FIGS. 3   c  and  3   d , so as to follow the groove of the wrist where the radial artery is located. 
         [0041]    As illustrated in  FIGS. 4   a  and  4   b , the button  18  is formed by a cylindrical inner tube  60   a  outwardly provided with a substantially conical gripping member  60   b  making it possible to facilitate handling of the button  14  by an operator. The cylindrical tube  60   a  has an inner diameter d 3  substantially equal to the outer diameter of the outer tube  50   b  of the support  50  of the applicator  12 . The inner face of the cylindrical tube  60   a  comprises a hollow screw pitch  62  capable of cooperating with the or each screw thread  56   b  of the applicator  12 . The cylindrical inner wall of the button  18  also comprises, at its base, a protruding inner skirt  65 , the dimensions and arrangement of which are chosen so as to cooperate, once the button  18  is mounted on the base  10 , with the assembly clips  26  thereof so as to block the translation of the button  18  along its longitudinal axis, but to leave the button  18  freely rotating around that same axis. Notches  66  are regularly arranged on the entire outer surface of the cylindrical tube  60   a  so that they are capable of cooperating with the pawl gadroon  32  of the two ribs  30  when the button  18  is mounted on the base  10 , to form stop means making it possible to maintain the button in a plurality of predetermined stable angular positions. If desired, to differentiate the force to be exerted on the button in the two directions, the notches can be asymmetrical. 
         [0042]    To facilitate the production of the button, the lower part of the button, comprising the skirt  64  and the notches  66 , could be another piece assembled (adhered or welded, for example) on the rest of the button. 
         [0043]    Once assembled, the applicator  12 , the button  18  and the base  10  are thus connected by a screw-and-nut system so that the rotation of the button translates the transparent pad. The screw threads  56   b ,  62  of the screw-and-nut system are situated completely outside the diameter of the transparent pad  14 . As a result, the view through the transparent pad  14  on the injection area is not hidden. 
         [0044]    As shown in  FIG. 5 , the bracelet  16  comprises, at one of its ends, two perforations  70 , the shape and arrangement of which make it possible, in cooperation with the hooks  38  of the base  10 , to secure said end to the base. The other end of the bracelet  16  comprises a plurality of through holes  72 , each able to cooperate with the fastening lug  36  to secure said end to the base  10 , the choice of the through hole making it possible to adjust the tightening of the bracelet  16  around the patient&#39;s wrist. 
         [0045]    Alternatively, the button  18  could be directly screwed into a hole of the base  10 , with the proximal end of the applicator  12  secured at least in translation to the button. 
         [0046]    In a second embodiment of the compressive hemostatic device according to the invention, shown in  FIGS. 6   a ,  6   b  and  6   c , the proximal end of the applicator  12 , which is completely transparent, is secured to a platen  70  whereof one end is connected to the base  10  by a hinge  72 . The applicator, with axis X-X, passes freely through an orifice  73  of the base. The other end of the platen  70  has a hole  74  parallel to the axis X-X. 
         [0047]    The button  18  comprises an upper portion  18   a  forming the head of the button  18 , on which angular references  18   b  are positioned. The button  18  comprises a lower portion  18   c  forming a threaded rod passing through the hole  74  and screwed into a nut  75  secured to the portion  10   b  of the base  10 . 
         [0048]    Advantageously, the nut  75  is designed so as to be able to deform enough to allow the translation of the button along its longitudinal axis when pressure is exerted along that axis on the head  18   a  by a user, thereby making it possible to move the button  18  more quickly than by screwing. To that end, the thread of the nut  75  can comprise flexible strips and be made from a material offering sufficient elasticity. 
         [0049]    The bracelet  16  comprises a flexible bracelet  80  whereof one end is secured to an end of the base  10  and extends the latter, the other end comprising a notched zone  82 . The notched zone is capable of cooperating with a locking/unlocking lever  84  provided at the proximal end of the base provided with the nut  75 . The lever  84  tends to assume its locking position elastically. 
         [0050]    Advantageously, the pad  14  protrudes relative to the base  10  toward the injection area irrespective of the position defined by the adjustment button. This guarantees that pressure is obtained on the injection area in all cases during placement of the device. 
         [0051]    Advantageously, the device according to the invention can comprise means for saving placement and removal times, allowing the person handling the device to save the time at which the device was placed on the patient, as well as the time at which the device must be removed or was actually removed. The means for saving placement and removal times can advantageously be positioned on the base  10 . 
         [0052]    In a first embodiment illustrated in  FIGS. 7   a ,  7   b  and  7   c , the means for saving the placement and removal times comprise a bowed ruler  100 , centered on the axis X-X, on which graduations  101   a ,  101   b  appear. Each graduation corresponds to a mark for the corresponding time. Typically, the marks go from 12 to 11, representing a time scale going from 12 hours to 11 hours, as shown in  FIG. 7   c . The ruler  100  comprises a first inner notched guideway  104 . A pin  102  provided with assembly clips  103  is mounted in the guideway  104 . The pin  102  can move frictionally in the guideway  104  and be maintained in a plurality of fixed positions each corresponding to one of the marks of the inner graduation  101   a . The ruler  100  comprises a second notched outer guideway  105  on which a pointer  106  slides. The pointer  106  can move frictionally in the second notched guideway and be positioned in a plurality of fixed positions each corresponding to one of the marks of the outer graduation  101   b . Notches provided in the two guideways can alternatively define predetermined stable positions of the pin  102  and the pointer  106 . 
         [0053]    In a second embodiment illustrated in  FIGS. 8   a  and  8   b , the means  100  for saving the placement and removal times comprise a dial  120  rotatably mounted around an axis  122 . Hour references are marked on the dial  120 , for example from 1 hour to 24 hours. A knurled peripheral part  123  of the dial is accessible to the user so that the latter can rotate the dial  120 . The dial  120  is partially concealed by a fixed opaque disk  124  covering the dial  120 . The opaque disk  124  also comprises a fixed index  126  positioned so as to allow pointing to a time reference of the dial  120  not covered by the opaque disk  124 . The part of the dial  120  left visible by the opaque disk  124  corresponds to a circular sector zone  125  whereof the dimensions make it possible to view a set of time references of the dial  120  corresponding to an hour range of 8 hours from the hour pointed to by the fixed index  126 . Also rotatably mounted around the axis  122  is a transparent disk  128  covering the opaque disk  124 . The transparent disk  128  is provided with a pointer  130  arranged so that a user can identify an hour mark of the dial  120  not covered by the opaque disk  124 . Indexing notches  132  are positioned on the opaque disk  124  and the transparent disk  128  so as to index the rotation of the transparent disk  128  over a plurality of predetermined angular positions. To facilitate the rotation of the transparent disk  128  by a user, a bulge  134  is positioned on the surface of the transparent disk  128 . 
         [0054]    The user can thus store the placement and implementation time of the device on the patient by rotating the dial  120  until the mark of the dial  120  corresponding to said placement time is designated by the fixed index  126 . The user can indicate the removal time of the device by rotating the transparent disk  128  until the pointer  130  designates the mark of the dial  120  corresponding to said removal time. 
         [0055]    Alternatively, in each embodiment, one and/or the other of the hour indicators can reference a change time, done or to be done, of the pressure exerted by the device. 
         [0056]    A combination of the two embodiments of the saving means illustrated in  FIGS. 7   a  to  7   c  and  8   a - 8   b  can be considered. 
         [0057]    It is also alternatively possible to produce a device comprising only one hour graduation. 
         [0058]    A third embodiment of the hemostatic device is shown in  FIGS. 9 to 14 . This device differs from the first embodiment only as follows:
       the base  10  does not comprise the supports  30  with the pawl protrusions  32 , but two outer vertical supports  200  and an intermediate vertical support  210 , protruding from the base  10  toward the button  18 . The support  210  is located in the vertical plane of symmetry P of the device, and the supports  200  at about 30° on either side of that plane.   the extension  34  rises above the plane of the planar portion  10   a  of the base  10 , is circular, and has a vertical slot  212  in plane P;   the button  18  does not comprise a gripping member  60   b , but only the inner cylindrical tube  60   a , said tube  60   a  also being a gripping member; and   the cylindrical tube  60   a  does not have the notches  66 , or the protruding inner skirt  64 , but comprises, in its portion oriented toward the base  10  ( FIGS. 13 and 14 ), an inner recess  214  and at least one tab  216  that protrudes vertically from the button  18  toward the base  10  ( FIG. 9 ).       
 
         [0063]    Relative to the first embodiment, the third embodiment of the hemostatic device also comprises a locking system  218 . 
         [0064]    The locking system  218  comprises a ring  220  and an anti-reverse latch  222 . The ring  220  is placed in the annular space situated between the flange  22  and the extension  34 . 
         [0065]    The ring  220  comprises an inner cylindrical ring  224  and an outer toothed crown  226 . The ring  220  is a single piece. The ring  220  is made from a copolymer, for example ABS. The ring  224  and the toothed crown  226  extend concentrically around the longitudinal axis X-X. The toothed crown  226  surrounds the ring  224 . The latter protrudes vertically from the toothed crown  226  toward the button  18  while forming a flange  228 . The ring  224  has, in its portion oriented toward the base  10 , a protruding inner skirt  230 , the function of which is similar to that of the corresponding skirt  64  of the button  18  of the first embodiment: by cooperating with the clips  26  of the base, the skirt  230  blocks the translation of the ring  220  along the longitudinal axis X-X, but leaves the ring  220  freely rotating around the same axis. 
         [0066]    The crown  226  has, on its end section oriented toward the base  10 , saw-teeth  232  oriented vertically. The teeth  232  are regularly distributed over the entire periphery of the toothed crown  226 . Alternatively, the teeth  232  are regularly distributed over a part corresponding to 180° or 270° of the periphery of the crown  226 . In its portion oriented opposite the base, the crown  226  has at least one notch  234  ( FIG. 9 ). 
         [0067]    The flange  228  of the ring  220  has an outer diameter adapted for frictional tightening in the recess  214  of the cylindrical tube  60   a  of the button  18  ( FIGS. 13 and 14 ). The or each notch  234  of the ring  220  is adapted to cooperate with the or each tab  216  of the button  18 . In this way, the ring  220  is secured in rotation to the button  18  around the axis X-X. 
         [0068]    The applicator  12  and its transparent pad  14  are substantially identical to those of the first embodiment. 
         [0069]    Alternatively, the ring  220  and the button  18  are connected to one another by adhesion or ultrasound welding. 
         [0070]    The anti-reverse latch  222  comprises a push button  236 , a locking pawl  238 , a bowed arm  240 , and a vertical rib  242  ( FIG. 10 ). The latch  222  is a single piece and is made from a polymer, such as POM. 
         [0071]    The push button  236  is connected to the pawl  238  via the vertical rib  242 . It is adapted to move the pawl  238  parallel to the axis X-X between a blocking position and an unblocking position. The pawl  238  has, in its portion oriented opposite the base, a shape complementary to that of one of the teeth  232  of the toothed crown  226 , so as to be able to cooperate with each of the teeth  232 . The portion oriented toward the base  10  of the pawl  238  is substantially connected to the central portion of the bowed arm  240 . 
         [0072]    In the blocking position, the bowed arm  240  extends substantially in a plane perpendicular to the axis X-X on either side of the pawl  238  ( FIG. 12 ). The bowed arm  240  describes an arc of circle having a diameter equal to or larger than the outer diameter d 1  of the inner tube  50   a  of the applicator  12 . 
         [0073]    The vertical slot  212  present in the extension  34  of the base  10  rises above the plane of the planar portion  10   a  of the base and is open opposite the base ( FIG. 9 ). The slot  212  has a width and length adapted to receive the vertical rib  242  of the latch  222  so that the push button  236  slidingly bears against the outer face of the extension  34  and the pawl  238  and the bowed arm  240  slidingly bears against the inner face of the extension  34  ( FIG. 11 ). Consequently, the push button  236  is accessible by a user, while the pawl  238  and the bowed arm  240  are not. 
         [0074]    Furthermore ( FIG. 11 ), the end portions of the arm  240  overhang the supports  200  of the base. 
         [0075]    As shown in  FIG. 11 , the anti-reverse latch  222  is located completely outside the diameter of the transparent pad  14 . 
         [0076]      FIG. 12  shows the two outer vertical supports  200  and the intermediate vertical support  210 , protruding from the base toward the button  18 . The support  210  protrudes from the base  10  to a lower height than the supports  200 . The height of the supports  200 ,  210  is such that the bowed arm  240  bears only against the outer supports  200  when the pawl  238  is in the blocking position, and the arm  240  is continuously bent, i.e. when the pawl  238  is in the blocking position or the unblocking position. 
         [0077]    When the pawl  238  is in the blocking position ( FIG. 12 ), the part of the pawl oriented opposite the base  10  is bearing against one of the teeth  232  of the toothed crown  226 . The incline of the teeth  232  enables the unidirectional rotation around the axis X-X of the ring  220  and therefore the button  18  when the pawl  238  is in this blocking position. In this example, the rotation of the button  18  is blocked in the direction of rotation driving the applicator  12  and the pad  14  opposite the injection area, while the rotation in the opposite direction, driving the applicator  12  and the pad  14  toward the injection area, is not blocked. The bowed arm  240  only bears on the supports  200 . 
         [0078]    To allow the rotation of the button  18  in the first aforementioned direction, i.e. to reduce the pressure exerted by the pad  14 , the user presses the push button  236 , against the elastic force exerted by the bowed arm  240 . This brings the pawl  238  into the unblocking position ( FIG. 14 ), in which it is not in contact with the teeth  232  of the toothed crown  226 . The bowed arm  240  is then vertically curved and bears against the intermediate support  210 . When the pawl  238  is in the unblocking position, the ring  220  and therefore the button  18  are free to rotate in both directions around the axis X-X. In that position, it is therefore possible to drive the applicator  12  and the pad  14  opposite the injection area so as to reduce the pressure exerted on that zone. 
         [0079]    In order to reduce the pressure of the pad  14  exerted on the injection area, it is crucial to bring the anti-reverse latch  222  into the unblocking position and rotate the button  18  in the corresponding direction. These two maneuvers are difficult or impossible to do with one hand, for example by a patient wearing the hemostatic device around a wrist. 
         [0080]    The locking system  218  is positioned completely outside the diameter of the pad  14  so as not to conceal the view through the transparent pad  14  on the injection area. This allows a user to position the hemostatic device according to the invention optimally on the injection area of a patient.