Patent Publication Number: US-2005125025-A1

Title: Styptic device

Description:
This application claims the benefit of Provisional Patent Application Ser. No. 60/526.918 filed Dec. 5, 2003. 
    
    
     FIELD OF THE INVENTION  
      The present invention relates to the general field of medical devices and is particularly concerned with a device for haemostatically sealing percutaneous vascular punctures.  
     BACKGROUND OF THE INVENTION  
      There exists a plurality of medical and/or surgical procedures that are carried out intravascularly or intralumenally. For example, in the treatment of vascular diseases, such as atherosclerosis, angioplasty and/or stenting are now widely accepted procedures.  
      Such procedures usually involve the percutaneous puncture and insertion of a hollow needle through a patient&#39;s skin and muscle tissue into the vascular system. A guide wire is then typically passed through the needle lumen into the patient&#39;s blood vessel accessed by the needle. The needle may be removed, and an introducer sheath may be advanced over the guide wire into the vessel, for example, in conjunction with or subsequent to, a dilator.  
      A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into position for performing a medical procedure such as, dilating the vessel, stenting of the latter, or the like.  
      In percutaneous transluminal coronary angioplasty, the catheter is typically introduced either in the radial or femoral artery and advanced through the artery to the coronary region. When the femoral artery is used, the latter may be located one half inch or more beneath the skin. Catheters typically have a diameter in the range of one millimetre and four millimetres, hence creating a significant puncture in the artery. Also, during the procedure, the catheter may be twisted or otherwise manipulated as it is advanced to the treatment site, hence potentially causing a further enlargement of the puncture.  
      Upon completion of the procedure, the devices and introducer sheath may be removed, leaving a puncture site in the vessel wall. Such procedures hence unavoidably present the problem of stopping the bleeding at the percutaneous puncture site after the procedure has been completed and after the instrument and any introducer sheaths used therewith have been removed.  
      At present, such bleeding is typically stopped by the application of direct digital pressure over the puncture site by a trained physician or other suitably trained medical personnel. Such direct pressure has to be properly applied for a sufficiently long period of time for haemostasis to occur so that the opening is effectively closed against further bleeding. The application of direct digital pressure over the puncture site, although somewhat useful, nevertheless suffers from numerous drawbacks.  
      First, the direct digital pressure application procedure constitutes an inefficient, if not wasteful, use of medical professional services. For example, in the case of punctures into relatively high pressure vessels, such as into the femoral artery or superficial femoral arteries, the pressure may have to be applied for as long as forty-five minutes for haemostasis to occur.  
      Second, the application of digital pressure over a relatively long period of time may result in fatigue, numbness, stiffness and/or pain occurring in the fingers, hands, wrists and/or forearms of the practitioner performing the procedure. Furthermore, repetition of the procedure over a period of time may cause repetitive-type stress injuries, such as carpal tunnel syndrome or the like.  
      Still furthermore, although the procedure is typically performed with gloves there exists a possibility that the glove could already have, or may develop, a tear, thereby allowing direct pressurized digital contact with potentially contaminating bodily fluids.  
      Third, it is often difficult for an individual to exert digital pressure of optimal magnitude, especially over a relatively long period of time. The magnitude of the pressure exerted may however prove to be particularly important in some situations. Indeed, should the magnitude of the pressure be suboptimal, a bruise or haematoma may form at the entry site since internal bleeding of the punctured artery continues until clotting blocks the puncture. On the contrary, should the applied pressure be too great, this may result in a substantial reduction, if not virtual arrest, of the flow of blood through the vessel. This, in turn, may lead to thrombosis of the vessel with potentially serious complications.  
      Yet another drawback associated with the conventional digital application of pressure at the puncture site results from the fact that the instrument and any introducer sheath used therewith is typically completely withdraw prior to the application of pressure at the puncture site. This results in a brief, yet vigorous, free-flow of blood through the puncture site, which may obscure the exact location of the puncture momentarily leading to further blood loss.  
      Still furthermore, the conventional method of digital pressure application of the puncture site is sometimes considered uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, holding area or the like hence using up valuable space.  
      Some styptic devices as been shown in the prior art, as exemplified by U.S. Pat. No. 5,307,811 issued May 3, 1994 to Ulrich Sigwart and Dan Akerfeldt. However, such prior art devices suffer from numerous drawbacks. Indeed, prior art device generally suffer from being unergonomical to the user and uncomfortable to the patient. Prior art devices also suffer from being overall too complex, and, hence, relatively expensive and potentially less reliable. Some prior art devices further suffer from requiring an external supporting surface and being deprived of a suitable pressure indicator.  
      Accordingly, there exists a need for an improved styptic device for hemostatically sealing percutaneous vascular punctures. It is a general objective of the present invention to provide such an improved styptic device.  
     SUMMARY OF THE INVENTION  
      In accordance with an embodiment of the invention, there is provided a styptic device for at least substantially hemostatically sealing a percutaneous vascular puncture formed in a body vessel and located at a target anatomical area of an intended patient, the target anatomical area being surrounded by a surrounding area of the intended patient, the styptic device comprising a base component positionable substantially adjacent the target anatomical site; a mounting component coupled to the base component for mounting the base component on the intended patient in a substantially adjacent relationship relative to the target anatomical site; a compressing component defining a compressing surface for exerting a compressing pressure on the target anatomical site, the compressing component being operatively coupled to the base component so as to be movable relative to the latter between a compressing configuration wherein the compressing surface exerts the compressing force on the target anatomical site and a retracted configuration wherein the compressing surface is spaced from the target anatomical site.  
      Typically, the base component includes a base component socket section, the base component socket section defining a socket channel extending therethrough, the socket channel being positionable substantially over the target anatomical site; the compressing component extending at least partially through the socket channel for movement between the compressing and retracted configurations.  
      Conveniently, the compressing component includes a compressing component coupling section for coupling the compressing component to the base component, the compressing component coupling section having a substantially cylindrical configuration and being provided, at least in part, with a coupling component external thread; the socket channel being provided, at least in part, with a socket internal thread for threaded engagement with the coupling component external thread.  
      Typically, the compressing component defines a compressing component first longitudinal end and a longitudinally opposed compressing component second longitudinal end; the compressing component defining a compressing component grasping section located substantially adjacent the compressing component first longitudinal end for facilitating the manipulation of the compressing component and a compressing component contacting section for contacting the target anatomical site, the compressing component contacting section defining the compressing surface.  
      Conveniently, the compressing component grasping section includes a grasping knob extending substantially radially outwardly from the compressing component adjacent the compressing component first longitudinal end.  
      Conveniently, the compressing component contacting section includes a contacting tongue, the contacting tongue providing the compressing surface with a substantially rectangular configuration defining a contacting surface long axis and a substantially perpendicular contacting surface short axis, the contacting tongue being configured, sized and positioned so that the contacting surface long axis extends substantially in the direction of the body vessel when the compressing component is in the compressing configuration.  
      Typically, the base component also includes a base component spacing section for maintaining the base component socket section in a substantially overlying spaced relationship relative to the target anatomical site.  
      Typically, the mounting component includes a mounting component mounting plate extending from the base component for contacting at least part of the surrounding area, the mounting component mounting plate being provided with a mounting plate access aperture extending therethrough for allowing access to the target anatomical site; and wherein the base component spacing section includes a spacing section peripheral wall extending between the mounting component mounting plate and the base component socket section for maintaining the base component socket section in a spaced relationship relative to the mounting component mounting plate; the spacing section peripheral wall being provided with a peripheral wall access aperture extending therethrough for allowing access to the mounting plate access aperture.  
      Conveniently, the spacing section peripheral wall includes a peripheral wall first section extending substantially perpendicularly from the mounting component mounting plate and a substantially frusto-conical peripheral wall second section extending from the peripheral wall first section, the peripheral wall second section defining a finger abutment area for allowing abutting contact therewith of some of the fingers of the intended user.  
      Typically, the peripheral wall first and second sections are circumferentially truncated so as to define the peripheral wall access aperture, the peripheral wall access aperture defining a peripheral wall access aperture peripheral edge, the peripheral wall access aperture peripheral edge defining a pair of peripheral edge first segments formed in the peripheral wall first section and extending substantially perpendicularly from the mounting component mounting plate and a radially inwardly recessed peripheral edge second segment formed in the peripheral wall second section and extending between the peripheral edge first sections.  
      Typically, the mounting plate access aperture defines a mounting plate access aperture protruding portion projecting outwardly from the spacing section beyond the peripheral wall access aperture peripheral edge.  
      Preferably, the spacing section defines a barrier receiving chamber for receiving a pressure transmitting contamination barrier component, the barrier receiving chamber being configured, positioned and sized so that the pressure transmitting contamination barrier component is positioned intermediate the compressing surface and the target anatomical site when the compressing component is in the compressing configuration.  
      Conveniently, the compressing component coupling section defines a first threaded portion located substantially towards the compressing component first longitudinal end, a second threaded portion located substantially towards the compressing component second longitudinal end and an unthreaded portion located intermediate the first and second threaded portions; the dimensional relationship between the base component socket section, the compressing component and the base component spacing section being such that when the second threaded portion threadably engages the socket internal thread, the compressing component is in a stand-by configuration wherein the compressing component contacting section is located substantially adjacent the base component socket section above the level of the mounting component mounting plate so as to be in an overlying spaced apart relationship relative to the target anatomical site when the styptic device is mounted on the intended patient; when the lowermost thread of the second threaded portion threadably disengages the coupling component internal thread so as to be moved underneath the socket channel, the unthreaded portion is put in register with the socket channel allowing the compression component to drop under the action of gravity to a compressing component contacting configuration wherein the lowermost thread of the first threaded portion is put into contact with the uppermost thread of the socket channel and the compressing surface is positioned substantially in register with the mounting component mounting plate so as to contact the target anatomical site when the styptic device is mounted on the patient; when the first threaded portion threadably engages the coupling component internal thread, the compressing component is in the compressing configuration with the compressing surface located underneath the mounting component mounting plate so as to compress the target anatomical site when the styptic device is mounted on the patient.  
      Typically, the mounting component mounting plate defines a mounting plate outer peripheral edge, the mounting plate outer peripheral edge being provided with a groin accommodating recess formed therein for accommodating the groin region of the intended patient.  
      Conveniently, the mounting component also includes a mounting plate adhesive material attached to the mounting component mounting plate for adhesively securing the mounting plate to the surrounding area.  
      Typically, the mounting component also includes at least one strap extending from the mounting component mounting plate for at least partially surrounding a body part of the intended patient.  
      Conveniently, the mounting component includes a main strip section extending substantially laterally from the mounting component mounting plate and an auxiliary strip section extending from the mounting component mounting plate substantially opposite the main strip section the main and auxiliary strip sections being configured and sized for together encircling a body part of the patient and being provided with complementary main-to-auxiliary strap attachment means for releasable attachment threrbetween when together encircling the body part.  
      Typically, the mounting component includes a first auxiliary strip section and a second auxiliary strip section both extending substantially laterally from the mounting component mounting plate, the first and second auxiliary strips diverging outwardly away from each other; the mounting component also including a main strip section extending from the mounting component mounting plate substantially opposite the first and second auxiliary strip sections; the first and second auxiliary strip sections and the main strip section being configured, sized and oriented so that the main strip section is adapted to substantially encircle the body part and releasably attach to the first and second auxiliary strip sections substantially transversally relative to the latter.  
      Typically, the first and second auxiliary strip sections are configured, sized and oriented so as to extend substantially in register respectively with the external portion of the corresponding thigh and the buttocks region of the patient while the main strip section is adapted to extend from the corresponding groin region of the patient, substantially around the corresponding thigh of the patient to the first and second strip sections when the compressive surface is substantially in register with the femoral artery of the patient  
      Conveniently, either one of the main strip section or the first and second auxiliary strip sections is provided with a strip adhesive material attached thereto for adhesively securing the either one of the main strip section or the first and second auxiliary strip sections to the surrounding area.  
      Typically, the styptic device further comprises an alignment means for facilitating the alignment of the pressure contacting surface with the body vessel.  
      Conveniently, the alignment indicia includes a first alignment indicia located on the compressing component contacting section and a second alignment indicia located on the base component, the first and second alignment indicia extending in a substantially perpendicular relationship relative to each other and being located so that the intersection of the projection thereof defines an alignment intersection adapted to be put in register with the target anatomical area of the patient.  
      Preferably, the styptic devise further comprises a pressure sensor for sensing the styptic pressure exerted by the compressing component on the target anatomical site and providing a usable indication of the magnitude of the styptic pressure.  
      Preferably, the pressure sensor provides an electrical output, the electrical output being transmittable through a corresponding sensor cable; whereby the sensor cable is adapted to be coupled to a pressure indicator.  
      In accordance with an alternative embodiment of the invention, the pressure sensor includes a compressible bladder mounted on the compressing surface, the compressible bladder being fluidly coupled to a magnitude indicating tube, the compressible bladder being filled, at least in part, by a substantially non-compressible fluid, the magnitude indicating tube being provided with a buoyant magnitude indicating component adapted to float on top of the non-compressible fluid and to move longitudinally within the magnitude indicating tube; whereby upon the styptic pressure being applied to the target anatomical site, the compressible bladder will be squeezed between the compressing surface and the target anatomical site, upon being squeezed, the compressible bladder will be compressed, forcing the non-compressible fluid into the magnitude indicating tube and modifying the level of the magnitude indicating component within the magnitude indicating tube.  
      In accordance with yet another embodiment of the invention, the pressure sensor includes a pressure rod mechanically coupled to the compressing surface, the pressure rod being slidably mounted within the compressing component for longitudinal movement threrein towards the compressing component first longitudinal end upon a pressure being exerted on the compressing surface; a biasing means coupled to the pressure rod for biasing the compressing component second longitudinal end; a pressure indicator mounted on the compressing component; a converting means coupled to the pressure indicator and to the pressure rod for converting the movement of the pressure rod into a pressure data indicated by the pressure indicator; whereby the biasing means is calibrated so that the pressure data corresponds substantially to the magnitude of pressure exerted by the compressing surface on the target anatomical area.  
      Advantages of the present invention include that the proposed device allows for haemostatic sealing of vascular puncture sites through a set of quick and ergonomic steps, without requiring special tooling or manual dexterity.  
      Furthermore, the proposed method and device allows for haemostatic sealing without requiring the direct intervention through the application of direct digital pressure for extended periods of time. Consequently, the proposed method and device allows physicians, nurses or other trained medical personnel to be used more efficiently.  
      The proposed method and device also allows other medical resources to also be used more efficiently since it allows the patient to be removed from the operating room, catheter lab, holding area or other valuable space once the device has been properly installed over the puncture site.  
      By eliminating the need for digital application of pressure over relatively long periods of time, the proposed method and device also reduces the occurrence of both acute and repetitive-type injuries to medical practitioners associated with the conventional method. The risk of contamination with bodily fluids is also substantially reduced.  
      Still furthermore, the proposed method and device allows for calibration of the pressure exerted at the puncture site and further allows the pressure to remain at the calibrated magnitude over the required period of time. Accordingly, the proposed method and device reduces the risks of haematoma, thrombosis or other problems associated with the application of pressures of improper magnitude.  
      Another advantage associated with the present invention resides in that the proposed device is designed so as to be comfortable for the patient during installation, use and removal thereof.  
      Yet still furthermore, the proposed device is designed so as to be easily scalable and/or configurable so as to allow customization thereof to various types of situations such as to various puncture sites and/or for various types of medical and/or surgical procedures.  
      Yet still furthermore, the proposed device is designed so as to be manufacturable using conventional materials and conventional forms of manufacturing so as to provide a device that will economical to manufacture. The device is also designed so as to be reliable and relatively trouble-free in operation. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      Various embodiments of the present invention will now be disclosed, by way of example, in reference to the following drawings, in which:  
       FIG. 1 , in a partial top view with sections taken out, illustrates the styptic device in accordance with an embodiment of the present invention;  
       FIG. 2 , in a perspective view, illustrates some of the components part of the styptic device shown in  FIG. 1 ;  
       FIG. 3 , in a top view, illustrates the components shown in  FIG. 2 ;  
       FIG. 4 , in a right-hand side view, illustrates the components shown in  FIGS. 2 and 3 ;  
       FIG. 5 , in a front view, illustrates the components shown in  FIGS. 2 through 4 ;  
       FIG. 6 , in a left-hand view, illustrates the components shown in  FIGS. 2 through 5 ;  
       FIG. 7 , in a rear view, illustrates the components shown in  FIGS. 3 through 6 ;  
       FIG. 8 , in a bottom view, illustrates the components shown in  FIGS. 2 through 7 ;  
       FIG. 9 , in a partially exploded view, illustrates the components shown in  FIGS. 2 through 8 ;  
       FIG. 10 , in a partial longitudinal cross-sectional view with sections taken out, illustrates some of the features of a base component part of the styptic device shown in  FIGS. 1 through 9 ;  
       FIG. 11 , in a partial close-up view, illustrates some of the features of the components shown in  FIG. 10 ;  
       FIG. 12 , in a top view, illustrates a grasping knob part of the styptic device shown in  FIGS. 1 through 11 ;  
       FIG. 13 , in a partial exploded view with sections taken out, illustrates some of the features of components part of the styptic device shown in  FIGS. 1 through 12 ;  
       FIG. 14 , in a transversal cross-sectional view, illustrates the configuration of the grasping knob shown in  FIG. 12 ;  
       FIG. 15 , in a partial detailed view taken inside circle D of  FIG. 13 , illustrates some of the features of the grasping knob shown in  FIGS. 12 through 14 ;  
       FIG. 16 , in a longitudinal cross-sectional view, illustrates some of the components of the styptic device shown in  FIGS. 1 through 15 , the compressing component thereof being shown in a stand-by configuration;  
       FIG. 17 , in a longitudinal cross-sectional view, illustrates the components shown in  FIG. 16 , with the compressing component shown in a contacting configuration;  
       FIG. 18 , illustrates the components shown in  FIGS. 16 and 17  with the compressing component shown in a compressing configuration;  
       FIG. 19 , in a bottom view, illustrates the styptic device shown in  FIG. 1 ;  
       FIG. 20 , in an exploded view, illustrates some of the sections of a mounting component part of a styptic device in accordance with an embodiment of the present invention;  
       FIG. 21 , in a perspective view, illustrates part of a styptic device in accordance with an alternative embodiment of the invention wherein the styptic device is provided with an alternative pressure sensing assembly;  
       FIG. 22 , in a partial bottom view with sections taken out, illustrates some of the features of the embodiment shown in  FIG. 21 ;  
       FIG. 23 , in a partial longitudinal cross-sectional view, illustrates some of the features of the embodiment shown in  FIGS. 21 and 22 ;  
       FIG. 24 , in a perspective view, illustrates part of a styptic device in accordance with yet another alternative embodiment of the invention wherein the styptic device is provided with an alternative pressure sensing assembly;  
       FIG. 25 , in a bottom view, illustrates one of the initial steps for mounting a styptic device in accordance with an embodiment of the present invention to the body of an intended patient,  FIG. 25  showing an intended user removing a peelable covering strip from an adhesive tape mounted on a mounting plate part of a styptic device in accordance with an embodiment of the present invention;  
       FIG. 26 , in a partial top view, illustrates the mounting plate being adhesively secured to the body of the intended patient;  
       FIG. 27 , illustrates a strap assembly being wrapped around the thigh of an intended patient;  
       FIG. 28 , illustrates a styptic device in accordance with an embodiment of the invention mounted on an intended patient and in a stand-by configuration;  
       FIG. 29 , illustrates a sterile gauze being inserted between a contacting tongue part of a styptic device in accordance with an embodiment of the present invention and a target anatomical area of the intended patient;  
       FIG. 30 , illustrates the hand of an intended user grasping a grasping knob part of a compressing component part of the styptic device for moving the compressing component towards its compressing configuration;  
       FIG. 31 , illustrates an intended user exerting pressure on the target anatomical site as a catheter is being removed therefrom; and  
       FIG. 32 , illustrates the styptic device mounted on the intended patient with its compressing component in a compressing configuration. 
    
    
     DETAILED DESCRIPTION  
      Referring to  FIG. 27 , there is shown a styptic device in accordance with an embodiment of the present invention, generally indicated by the reference numeral  10 . The styptic device  10  is intended to be used mainly for haemostatically sealing percutaneous vascular punctures. It should, however, be understood that the device  10  could be used in numerous other contexts as a guiding means, and/or pressure creating means, for respectively guiding the insertion of a medical or surgical tool during insertion thereof in a body tissue and/or exerting a predetermined pressure on a body site, without departing from the scope of the present invention.  
      Also, the styptic device  10  in accordance with the present invention is hereinafter disclosed mainly for use in the specific context of the cannulation of the femoral artery for the purpose of heart catheterization or coronary angioplasty. It should, however, be understood that the styptic device  10  could be designed for other types of cannulation at other body sites without departing from the scope of the present invention. For example, the present invention could easily be scaled and configured for cannulation at radial body sites and/or for drawing arterial blood gases, or any other suitable purpose.  
      The styptic device  10  is typically used for at least substantially haemostatically sealing a percutaneous vascular puncture formed in a body vessel (not shown) and located at a target anatomical area  12  of an intended patient. The target anatomical area  12  is surrounded by a surrounding area  14  of the intended patient.  
      In general terms, the styptic device  10  includes a base component  16  positionable substantially adjacent the target anatomical site  12 . The styptic device  10  also includes a mounting component  18  coupled to the base component  16  for mounting the base component  16  on the intended patient in a substantially adjacent relationship relative to the target anatomical site  12 .  
      The styptic device  10  further includes a compressing component  20  defining a compressing surface  22  for exerting a compressing pressure on the target anatomical site  12 . The compressing component  20  is operatively coupled to the base component  16  so as to be moveable relative to the latter between a compressing configuration and a retracted configuration. In the compressing configuration shown, for example, in  FIG. 31 , the compressing surface  22  exerts the compressing force on the target anatomical site  12 . In the retracted configuration, shown for example in  FIG. 28 , the compressing surface  22  is spaced from the target anatomical site  12 .  
      Referring now more specifically to  FIGS. 2 through 18 , there is shown some of the features of the base and compressing components  16 ,  20 . As shown more specifically in  FIGS. 10 and 16  through  18 , the base component  16  includes a base component socket section  24 . The base component socket section  24  defines a socket channel  26  extending longitudinally therethrough. The socket channel  26  is typically positionable substantially over the target anatomical site  12 .  
      The compressing component  20  extends at least partially through the socket channel  26  for movement between the compressing and retracted configurations. The compressing component  20  includes a compressing component coupling section  28  for coupling the compressing component  20  to the base component  16 .  
      The compressing component coupling section  28  typically has a substantially cylindrical configuration and is provided, at least in part, with a coupling component external thread  30 . The socket channel  26  is provided, at least in part, with a complementary socket internal thread  32  for threaded engagement with the coupling component external thread  30 .  
      As illustrated more specifically in  FIG. 9 , the compressing component  20  defines a compressing component first longitudinal end  34  and a longitudinally opposed compressing component second longitudinal end  36 . The compressing component  20  defines a compressing component grasping section  38  located substantially adjacent the compressing component first longitudinal end  34  for facilitating the manipulation of the compressing component  20 .  
      The compressing component  20  also defines a compressing component contacting section  40  for contacting the target anatomical site  12 . The compressing component contacting section  40  defines the compressing surface  22 .  
      Typically, the compressing component grasping section  38  includes a grasping knob  42  extending substantially radially outwardly from the compressing component  20  adjacent the compressing component first longitudinal end  34 . Typically, although by no means exclusively, the grasping knob  42  has a substantially disc-shaped configuration. As shown more specifically in  FIGS. 16 through 18 , the grasping knob  42  typically includes a knob flange  44  depending therefrom. The knob flange  44  is typically provided with friction enhancing protrusions  46  extending radially outwardly therefrom.  
      As shown in  FIG. 9 , the compressing component contacting section  40  typically includes a contacting tongue  48 . As shown more specifically in  FIG. 8 , the contacting tongue  48  typically provides the compressing surface  22  with a substantially rectangular or ovaloïd configuration defining a contacting surface long axis  50  and a substantially perpendicular contacting surface short axis  52 . The contacting tongue  48  is configured, sized and positioned so that the contacting surface long axis  50  extends substantially in the direction of the body vessel when the compressing component  20  is in the compressing configuration.  
      As shown throughout the Figures, the contacting tongue  48  is typically releasably attached to the compressing component coupling section  28 . It should, however, be understood that the contacting tongue  48  could be permanently fixed to the compressing component coupling section  28  without departing from the scope of the present invention or that other types of releasable coupling means could be used for releasably coupling the contacting tongue  48  to the compressing component coupling section  28  without departing from the scope of the present invention.  
      As illustrated more specifically in  FIGS. 2, 10 , and  16  through  18 , the base component  16  also includes a base component spacing section  54  for maintaining the base component socket section  24  in a substantially overlying space relationship relative to the target anatomical site  12 .  
      As illustrated more specifically in  FIG. 20 , the mounting component  18  typically includes a mounting component mounting plate  56  extending from the base component  16  for contacting at least part of the surrounding area  14 . The mounting component mounting plate  56  is provided with a mounting plate access aperture  58  extending therethrough for allowing access to the target anatomical site  12  when the styptic device  10  is mounted on the intended patient.  
      As illustrated more specifically in  FIGS. 2, 10 , and  16  through  18 , the base component spacing section  54  includes a spacing section peripheral wall  60  adapted to extend between the mounting component mounting plate  56  and the base component socket section  24  for maintaining the base component socket section  24  in a spaced relationship relative to the mounting component mounting plate  56 . The spacing section peripheral wall  60  is provided with a peripheral wall access aperture  62  extending therethrough for allowing access to the mounting plate access aperture  58  when the styptic device  10  is mounted on the intended patient.  
      As illustrated more specifically in  FIG. 2 , the spacing section peripheral wall  60  includes a peripheral first section  64  adapted to extend substantially perpendicularly from the mounting component mounting plate  56  and a substantially frustro-conical peripheral wall second section  66  extending from the peripheral wall first section  64 . As shown more specifically in  FIGS. 4 and 6 , the peripheral wall second section  66  defines a finger abutment area  68  for allowing abutting contact therewith of some of the fingers of the intended user.  
      Referring back to  FIG. 2 , there is shown that the peripheral wall first and second sections  64 ,  66  are circumferentially truncated so as to define the peripheral wall access aperture  62 . The peripheral wall access aperture  62 , in turn, defines a peripheral wall access aperture peripheral edge. The peripheral wall access aperture peripheral edge, in turn, defines a pair of peripheral edge first segments  68  formed in the peripheral wall first section  64  and extending substantially perpendicularly from the mounting component mounting plate  56 .  
      The peripheral wall access aperture peripheral edge also defines a radially inwardly recessed peripheral edge second segment  70  formed in the peripheral wall second section  66  and extending between the peripheral edge first sections  68 . The recessed peripheral edge second segment  70  is adapted to facilitate manipulation and visualization during operational steps associated with the use of the styptic device  10 .  
      As illustrated more specifically in  FIGS. 27 , and  30 , the mounting plate access aperture  58  defines a mounting plate access aperture protruding portion  72  projecting outwardly from the spacing section  54  beyond the peripheral wall access aperture peripheral edge. The mounting plate access aperture protruding portion  72  is also adapted to facilitate manipulation and visualization during operational steps associated with the use of the styptic device  10 .  
      As illustrated more specifically in  FIG. 28 , the spacing section  54  defines a barrier-receiving chamber  74  for receiving a pressure transmitting contamination barrier component  76 . The barrier receiving chamber  74  is configured, positioned and sized so that the pressure transmitting contamination barrier component  76  is positioned intermediate the compressing surface  22  and the target anatomical site  12  when the compressing component  20  is in the compressing configuration.  
      Typically, the pressure transmitting contamination barrier component  76  takes the form of a strip of material suitable for transmitting the compressive force exerted by the compressing component  20  on the target anatomical site  12  while acting as a biological barrier, or retardant, against contamination thereof by pathogenic organisms. Typically, although by no means exclusively, the pressure transmitting contamination barrier component may take the form of a sterile gauze or film or any other suitable medium. Typically, although by no means exclusively, the barrier receiving chamber is configured and sized for receiving a conventional 2-inch by 3-inch sterile gauze.  
      As illustrated more specifically in  FIGS. 10 , and  16  through  18 , the peripheral wall first section  64  is typically provided with a barrier component receiving aperture  78  extending therethrough for allowing at least a portion of the contamination barrier component  76  to extend therethrough. Typically, the barrier component receiving aperture  78  allows a corner portion of the contamination barrier component  76  to extend therethrough so as to optimize the configuration of the barrier receiving chamber  74 , taking into consideration other criteria such as the optimal shape of the mounting component mounting plate  56 .  
      As illustrated more specifically in  FIGS. 9 , and  16  through  18 , the compressing component coupling section  28  defines a first threaded portion  80  located substantially towards the compressing component first longitudinal end  34 . The compressing component coupling section  28  also defines a second threaded portion  82  located substantially towards the compressing component second longitudinal end  36 . The compressing component coupling section  28  further defines an unthreaded portion  84  located intermediate the first and second threaded portions  80 ,  82 .  
      As shown more specifically in  FIG. 16 , the dimensional relationship between the base component socket section  24 , the compressing component  20  and the base component spacing section  54  is such that when the second threaded portion  82  threadably engages the socket internal thread  32 , the compressing component  20  is in a stand-by configuration. In the stand-by configuration, the compressing component contacting section  40  is located substantially adjacent the base component socket section  24  above the level of the mounting component mounting plate  56  so as to be in an overlying spaced apart relationship relative to the target anatomical site  12  when the styptic device  10  is mounted on the intended patient.  
      Typically, although by no means exclusively, the second threaded portion  82  includes a small number of threads such as a single thread. When the lowermost or only thread of the second threaded portion  82  threadably disengages the coupling component internal thread  32  so as to be moved underneath the socket channel  24 , the unthreaded portion  84  is put in register with the socket channel  24  allowing the compression component  20  to drop under the action of gravity to a compressing component contacting configuration shown in  FIG. 17 . In the compressing component contacting configuration, the lowermost thread of the first threaded portion  80  is put in contact with the uppermost thread of the socket channel  24  and the compressing surface  22  is positioned substantially in register with the mounting component mounting plate  56  so as to contact the target anatomical site  12  when the styptic device  10  is mounted on the patient.  
      The dimensional relationship between the base component socket section  24 , the compressing component  20  and the base component spacing section  54  is also such that when the first threaded portion  80  threadably engages the socket internal thread  32 , the compressing component  20  is in the compressing configuration with the compressing surface  22  located underneath the mounting component mounting plate  56  so as to compress the target anatomical site when the styptic device  10  is mounted on the intended patient.  
      The mounting component mounting plate  56  defines a mounting plate outer peripheral edge. As shown more specifically in  FIG. 27 , the mounting plate outer peripheral edge is typically provided with a groin accommodating recess  86  formed therein. The groin accommodating recess  86  is configured and sized for accommodating a corresponding groin region  88  of the intended patient so as to improve the comfort of the latter.  
      As shown more specifically in  FIG. 20 , the mounting component  18  typically further includes a mounting plate adhesive material  88  adapted to be attached to the mounting component mounting plate  56  for adhesively securing the mounting component mounting plate  56  to the surrounding area  14 . Typically, the mounting component adhesive material  88  includes a double-sided adhesive tape  90 .  
      The double-sided adhesive tape  90  has a first side  92  thereof adhesively secured to the undersurface of the mounting component mounting plate  56  and a second side thereof (not shown) releasably covered by a peelable protective strip  94  (shown in  FIG. 19 ). The peelable protective strip  94  typically has a strip prehension tongue  96  projecting outwardly therefrom to facilitate grasping of the peelable protective strip during the peeling thereof from the second side of the double-sided adhesive tape  90 .  
      The double-sided adhesive tape  90  is typically configured and sized so as to substantially conform to the configuration of the mounting component mounting plate  56 . Also, the double-sided adhesive tape  90  is typically provided with a mounting plate tape aperture  91  extending therethrough for facilitating manipulation and visualization during installation of the styptic device  10  on the intended patient.  
      Typically, the mounting component  18  also includes at least one strap extending from the mounting component mounting plate  56  for at least partially surrounding a body part of the intended patient. Typically, the mounting component  18  includes a first auxiliary strip section  98  and a second auxiliary strip section  100  both extending substantially laterally from the mounting component mounting plate  56 . The first and second auxiliary strips  98 ,  100  typically diverge substantially outwardly away from each other.  
      The mounting component  18  also typically also includes a main strip section  102  extending from the mounting component mounting plate  56  substantially opposite the first and second auxiliary strip sections  98 ,  100 . The first and second auxiliary strip sections  98 ,  100  and the main strip section  102  are configured, sized and oriented relative to the mounting component mounting plate  56  so that the main strip section  102  is adapted to substantially encircle the intended body part of the intended patient and releasably attached to the first and second auxiliary strip section  98 ,  100  substantially transversally relative to the latter.  
      In situations wherein the styptic device  10  is intended to be used for haemostatically sealing a percutaneous vascular puncture formed in the femoral artery of a patient, the first and auxiliary strip sections  98 ,  100  are configured, sized and oriented relative to the mounting component mounting plate  56  so as to be located respectively substantially in register with the exterior face of the thigh of the intended patient and at least a portion of the buttocks of the intended patient. In such situations, the main strip section  102  is configured and sized so as to encircle the thigh of the intended patient substantially from the groin area of the latter to the first and second auxiliary strips sections  98 ,  100 .  
      It should, however, be understood that the configuration and size of the mounting component strap or straps may differ substantially from that shown throughout the drawings without departing from the scope of the present invention.  
      Typically, the main strip section  102  and the first and second auxiliary strip sections  98 ,  100  are adapted to be releasably attached together using suitable releasable attachment means. In a preferred embodiment of the invention, the main strip section  102  and the first and second auxiliary strip sections  98 ,  100  are provided with portions of complementary miniature hook and loop fibre located adjacent distal ends thereof for allowing the main strip section  102  to releasably attach to the first and second auxiliary strip sections  98 ,  100 . As shown in  FIGS. 19 and 20 , a removable protective strip  104  is typically releasably attached to the portion of complementary miniature hook and loop fibre of the main strip section  102  for protection against soiling or contamination prior to use.  
      The mounting component  18  is typically further provided with strap adhesive material attached to the main strip section  102  and the first and second auxiliary strip sections  98 ,  100  for adhesively securing the latter to the surrounding area. Typically, the strap adhesive material includes corresponding double-sided adhesive tapes, each having a first side thereof adhesively secured to the corresponding strip section and a second side thereof releasably covered by a peelable protective strip  94 .  
      The styptic device  10  typically further includes an alignment means for facilitating the alignment of the pressure contacting surface  22  with the body vessel (not shown). As shown more specifically in  FIG. 2 , the alignment means typically includes a first alignment indicia  106  located on the compressing component contacting section and a second alignment indicia  108  located on the base component  16 . The first and second alignment indicia  106 ,  108  typically extend in a substantially perpendicular relationship relative to each other and are located so that the intersection of the projection thereof defines an alignment intersection location adapted to be put in register with the target anatomical site  12  of the intended patient.  
      Typically, although by no means exclusively, the first alignment indicia  106  includes an indicia protrusion or recess formed on the top surface of the contacting tongue  48  while the second alignment indicia  108  is grooved, traced or otherwise marked on the peripheral wall first section  64 . It should, however, be understood that other types of alignment indicia could be used without departing from the scope of the present invention.  
      As illustrated more specifically in  FIG. 20 , the main strip section  102  and the first and second auxiliary strip sections  98 ,  100  typically merge integrally into a strip connection segment  110 . The strip connecting segment  110  is secured to the mounting component mounting plate  56 .  
      Typically, the strip connecting segment  110  is secured to the upper surface of the mounting component mounting plate  56 . Also, typically, the strip connecting segment  110  is configured and sized so as to substantially conform to the configuration of the mounting component mounting plate  56 . Hence, typically, the strip connecting segment  110  is typically provided with a connecting segment aperture  112  extending therethrough and adapted to be put in register with the mounting plate access aperture  58 .  
      As shown throughout the Figures and, more specifically in  FIG. 10 , the base component  16  is provided with at least one and typically two base component attachment flanges  114  extending substantially laterally from the lower peripheral edge of corresponding peripheral wall first sections  64 . As shown more specifically in  FIG. 11 , the base component attachment flanges  114  are typically secured between the mounting component mounting plate  56  and the strip connecting segment  110  for securing the base component  16  to the mounting component mounting plate  56 .  
      The styptic device  10  is typically further provided with a pressure evaluating component or pressure sensor for allowing an intended user to evaluate the pressure exerted by the pressure component  20  on the target anatomical site.  
      In a preferred embodiment of the invention illustrated in  FIG. 24 , the pressure sensor provides an electrical output. The electrical output is transmittable through at least one corresponding sensor cable  116 . The sensor cable  116  is adapted to be coupled to a suitable monitoring emitter.  
      Typically, although by no means exclusively, the pressure sensor may include piezo-electric components or any other suitable pressure sensing component  118 . The pressure sensor is typically located on the contacting tongue  48  so as to be in contact with the compressing surface  22 .  
      It should be understood that any suitable type of pressure sensor could be used without departing from the scope of the present invention. Also, the pressure sensor could be located at any suitable location without departing from the scope of the present invention. Furthermore, any suitable number of sensor cables  116  could be used with any suitable type of cable-to-emitter display plug  120  without departing from the scope of the present invention.  
      Furthermore, the monitoring emitted by the pressure indicator may be addressed to any sensorial modality. For example, the monitoring emitter may provide a visual display and/or an audio signal and/or a tactile signal without departing from the scope of the present invention.  
      Still furthermore, the monitoring emitter may provide a continuous indication as to the magnitude of the styptic pressure. It may also provide an alert signal upon the styptic pressure reaching a predetermined threshold or otherwise provide any other type of useful indication about the magnitude of the styptic pressure without departing from the scope of the present invention.  
       FIGS. 21 through 23  illustrate an alternative embodiment of a pressure sensor wherein a compressible bladder  122  is mounted on the compressing surface  22 . The compressible bladder  122  is fluidly coupled to a magnitude indicating tube  124 . Typically, although by no means exclusively, the compressible bladder  122  is mounted on the bottom surface of the contacting tongue  48  while the magnitude indicating tube  124  extends through the latter.  
      The compressible bladder  122  is filled, at least in part, by a substantially non-compressible fluid. The magnitude indicating tube  124  is provided with a buoyant magnitude indicating component  126  therein. The magnitude indicating component  126  is adapted to float on top of the non-compressible fluid and to move longitudinally within the magnitude indicating tube  124 . The magnitude indicating tube  124  is made out of a substantially transparent or translucid material so as to allow visualization of the relative position of the magnitude indicating component  126  therein.  
      Typically, the non-compressible fluid is a suitable liquid while the magnitude indicating component  126  is a buoyant sphere. Also, typically, the magnitude indicating tube  124  is provided with magnitude indicating indicia (not shown) for allowing evaluation of the magnitude of the styptic pressure depending on the relative position of the magnitude indicating component  126  within the magnitude indicating tube  124 .  
      Upon the styptic pressure being applied to the target anatomical site  12 , the compressible bladder  122  is squeezed between the compressing surface  22  and the target anatomical site  12 . Upon being squeezed, the compressible bladder  122  is compressed, hence forcing the non-compressible fluid into the magnitude indicating tube  124  and modifying the level of the magnitude indicating component  126  within the magnitude indicating tube  124 .  
      In yet another alternative embodiment of the invention illustrated more specifically in  FIGS. 16 through 18 , the pressure sensor includes a pressure rod  128  mechanically coupled to the compressing surface, typically by the contacting tongue  48 . The pressure rod  128  is slidably mounted within the hollowed-out compressing component  20  for longitudinal movement threrein towards the compressing component first longitudinal end  34  upon a pressure being exerted on the compressing surface.  
      The embodiment illustrated more specifically in  FIGS. 16 through 18  also includes a biasing means (not shown) coupled to the pressure rod  128  for biasing the latter towards the compressing component second longitudinal end  16 . A pressure indicator  130  is mounted on the compressing component  20 .  
      A converting means  132  (shown schematically) is coupled to the pressure indicator  130  and to the pressure rod  128  for converting the movement of the pressure rod  128  into a pressure data indicated by the pressure indicator  130 . The biasing means is typically calibrated so that the pressure data corresponds substantially to the magnitude of pressure exerted by the compressing surface  22  on the target anatomical area  12 . Typically, although by no means exclusively, the pressure indicator  130  is a dial mounted on the grasping knob  34 .  
      In use, as shown in  FIG. 25 , one of the initial steps for installing the styptic device  10  on the intended patient includes removing the peelable protective strip  94  from the double-sided adhesive tape  90 .  
      As shown in  FIG. 26 , with the compressing component  20  in the stand-by configuration, the mounting component mounting plate  56  is then positioned using the first and second guiding indicia  106  and  108  so that compressing surface  22  is substantially in register with the target anatomical site  12 . Digital pressure is applied on the top surface of the mounting component mounting plate  56  so as to adhesively secure the latter to the skin of the intended patient about the surrounding area  14 .  
      The peelable protective strip  94  is then removed from the double-sided adhesive tape of the strap adhesive material  104  of the main strip section  102  and the first and second auxiliary strips  98 ,  100  for allowing the latter to be adhesively secured to the surrounding area  14 . The main strip section  102  is wrapped around the thigh of the intended patient substantially from the groin area  88  of the latter to the first and second auxiliary strip sections  98 ,  100  so as to encircle the thigh of the intended patient such as shown in  FIG. 27 .  
      As illustrated more specifically in  FIG. 28 , the first and second auxiliary strip sections  98 , 100  are configured, sized and oriented relative to the mounting component mounting plate  56  so as to be located respectively substantially in register with the exterior face of the thigh and at least a portion the buttocks area of the intended patient. The sections of miniature hook and loop fibres allows the main strip section  102  to be releasably attached to the first and second auxiliary strip sections  98 ,  100  typically in a substantially transverse relationship relative to the latter.  
      This specific configuration is intended to optimize the distribution of pressure on the body of the patient so as to counteract the pressure exerted by the compressing component  20  with reduced risks of the base component  18  being lifted from the patient&#39;s body and with minimal discomfort to the patient.  
      As illustrated in  FIG. 29 , a sterile gauze  76  is then typically inserted in the chamber  74  between the compressing surface  22  and the target anatomical site  12  through the peripheral wall access aperture  62 .  
      As illustrated in  FIG. 30 , the grasping knob  42  is then grasped by the hand of an intended user to rotate the compressing component  20  so as to cause the lowermost thread of the second threaded portion  82  to disengage the coupling component internal thread  32  and allow the compressing component  20  to drop under the action of gravity towards the compressing component contacting configuration shown in  FIG. 17 .  
      As shown in  FIG. 31 , the other hand of the intended user may then be used to pull out the catheter C from the puncture site while the compressing component  20  is further rotated so as to cause the first threaded portion  80  to threadably engage the socket internal thread  32  for compressing the target anatomical site  12 . Typically, rotation of the compressing component  20  while in the compressing configuration is continued until the exerted pressure reaches a predetermined threshold that can be monitored using the provided pressure sensor.