WO2015008240A1

WO2015008240A1 - Hemostatic device

Info

Publication number: WO2015008240A1
Application number: PCT/IB2014/063160
Authority: WO
Inventors: Guy Belanger; Normand Mercier; Luc Bilodeau
Original assignee: G.B.O. Mercier Inc.
Priority date: 2013-07-16
Filing date: 2014-07-16
Publication date: 2015-01-22
Also published as: CA2917386A1

Abstract

A hemostatic device (10) attachable to a patient with first and second straps (14), the hemostatic device (10) comprising: a device body (20), the device body (20) including a compression portion (22) defining a compression surface (24) for compressing against the patient (12) and a strap attachment assembly mounting portion (28); and a strap attachment assembly (18) mounted to the strap attachment assembly mounting portion (28), the strap attachment assembly (18) including four strap attachments (52, 54, 70, 72) for attaching the first and second straps (14) thereto, at least two of the four strap attachments (52, 54, 70, 72) being rotatable independently from each other relative to the device body (20).

Description

TITLE OF THE INVENTION

HEMOSTATIC DEVICE

FIELD OF THE INVENTION

[0001] The present invention relates to the general field of medical devices and is particularly concerned with a hemostatic device device for hemostatically sealing percutaneous vascular punctures.

BACKGROUND

[0002] 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, percutaneous angioplasty and stenting are now widely accepted procedures.

[0003] Such procedures usually involve the percutaneous puncture and insertion of a hollow needle through a patient's skin and muscle tissue into the vascular system. A guide wire is then typically passed through the needle lumen into the patient'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.

[0004] 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. [0005] 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. Catheters typically have a diameter in the range of one millimeter and four millimeters, 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.

[0006] 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. To that effect, pressure is applied at the puncture site. This pressure must be applied until natural body repair mechanisms block blood flow. For example, this pressure must be applied for one hour or more.

[0007] This relatively lengthy duration, along with the need to apply a regulated amount of pressure, large enough to block blood flow, but not enough to prevent flow through the blood vessel, led to the creation of many devices to exert this pressure. However, there is a location where application of this pressure can be difficult. Indeed, many procedures require access to the femoral artery, in the inguinal area. Secure positioning of the hemostatic device in this area can be relatively difficult, for example, in the case of overweight patients. There are currently no devices that can be attached to such patients while conforming to the anatomy of a relatively wide range of morphologies. [0008] Accordingly, there exists a need for an improved hemostatic device for hemostatically sealing percutaneous vascular punctures. It is a general objective of the present invention to provide such an improved hemostatic device.

SUMMARY OF THE INVENTION

[0009] In a broad aspect, the invention provides a hemostatic device attachable to a patient with first and second straps, the hemostatic device comprising: a device body, the device body including a compression portion defining a compression surface for compressing against the patient and a strap attachment assembly mounting portion; a strap attachment assembly mounted to the strap attachment assembly mounting portion, the strap attachment assembly including a first strap attachment element, the first strap attachment element including a first attachment element body and substantially opposed first element first and second attachments extending therefrom, the first element first and second attachments being configured for attaching the first strap thereto; a second strap attachment element, the second strap attachment element including a second attachment element body and substantially opposed second element first and second attachments extending therefrom, the second element first and second attachments being configured for attaching the second strap thereto. The first and second strap attachment elements are rotatable independently from each other relative to the device body.

[0010] Advantageously, the proposed hemostatic device, due to the rotation of the first and second strap attachment elements, allows proper attachment of the hemostatic device to patients having different morphologies.

[0011] In some embodiments of the invention, the first and second strap attachment elements are rotatable independently from each other relative to the device body about respectively first and second attachment element rotation axes.

[0012] For example, the first and second attachment element rotation axes are substantially perpendicular to the compression surface. In another example, the first and second attachment element rotation axes are substantially collinear.

[0013] In some embodiments of the invention, the strap attachment assembly mounting portion is substantially opposed to the compression surface.

[0014] In some embodiments of the invention, the compression surface is substantially trapezoidal. This configuration of the compression surface is advantageous in applying proper pressure in the inguinal area of patients having various morphologies.

[0015] In some embodiments of the invention, the compression surface defines substantially opposed compression surface first and second end edges and compression surface side edges extending therebetween, the compression surface first end edge being shorter than the compression surface second end edge.

[0016] In some embodiments of the invention, the device body includes a substantially rigid device body core and the compression portion includes a gel mounted to the device body core, the gel being less rigid than the device body core.

[0017] In some embodiments of the invention, the device body core defines a device body aperture extending therethrough and reaching the gel; and the first and second strap attachment elements are configured to provide access to the device body aperture when mounted to the device body. This configuration facilitates the use of the hemostatic device in conjunction with an ultrasound or Doppler probe to monitor blood flow in an artery compressed using the hemostatic device.

[0018] In some embodiments of the invention, the first element first attachment is removably attachable to the first attachment element body. This allows securing the straps to the first element first attachment and adjusting the length thereof before attaching the first element first attachment to the first attachment element body, which is efficient, fast and ergonomic.

[0019] In some embodiments of the invention, the second element first attachment is removably attachable to the second attachment element body.

[0020] In some embodiments of the invention, the first element first attachment is movable between a locked position in which the first element first attachment is secured to the first attachment element body and an unlocked position in which the first element first attachment is freely movable away from the first attachment element body, the first element first attachment pivoting relative to the first attachment element body about an attachment pivot axis when the first element first attachment moves between the locked and unlocked positions. For example, the attachment pivot axis is substantially parallel to the compression surface.

[0021] In some embodiments of the invention, the first element first attachment includes a resiliently deformable latch for selectively locking the first element first attachment to the first attachment element body when the first element first attachment is in the locked position.

[0022] In some embodiments of the invention, the first attachment element body defines a first element attachment receiving portion for removably attaching the first element first attachment thereto, the first element attachment receiving portion defining opposed attachment element receiving portion upper and lower surfaces, the attachment element receiving portion lower surface facing towards the compression surface; the first element first attachment defining upper and lower tongues engaging respectively the attachment element receiving portion upper and lower surfaces when the first element first attachment is attached to the first element attachment receiving portion.

[0023] In some embodiments of the invention, the first and second attachment element bodies each include a substantially annular central portion and a pair of substantially opposed attachment receiving portions extending therefrom.

[0024] In some embodiments of the invention, the device body includes a substantially rigid device body core and the compression portion includes a gel mounted to the device body core, the gel being less rigid than the device body core; the device body core defines a device body aperture aperture extending therethrough and reaching the gel; and the central portions are superposed and each define a respective central portion aperture in register with the device body aperture.

[0025] In some embodiments of the invention, the first element first attachment defines an aperture for receiving the first strap therethrough. [0026] In some embodiments of the invention, the first and second attachment element bodies are removably mountable to the device body.

[0027] In another broad aspect, the invention provides a hemostatic device attachable to a patient with first and second straps, the hemostatic device comprising: a device body, the device body including a compression portion defining a compression surface for compressing against the patient and a strap attachment assembly mounting portion; and a strap attachment assembly mounted to the strap attachment assembly mounting portion, the strap attachment assembly including four strap attachments for attaching the first and second straps thereto, at least two of the four strap attachments being rotatable independently from each other relative to the device body.

[0028] Other objects, advantages and features of the present invention will become more apparent upon reading of the following non-restrictive description of preferred embodiments thereof, given by way of example only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0029] In the drawings:

[0030] FIGURE 1 , in a schematic view, illustrates a hemostatic device in accordance with an embodiment of the present invention secured to a patient using a pair of straps;

[0031] FIGURE 2, in a perspective exploded view, illustrates a hemostatic device in accordance with another embodiment of the invention usable in the configuration shown in FIG. 1 ;

[0032] FIGURE 3, in an alternative perspective exploded view, illustrates the hemostatic device shown in FIG. 2;

[0033] FIGURE 4, in a side elevation view, illustrates the hemostatic device shown in FIGS. 2 to 3;

[0034] FIGURE 5, in a front elevation view, illustrates the hemostatic device shown in FIGS. 2 to 4;

[0035] FIGURE 6, in a bottom plan view, illustrates the hemostatic device shown in FIGS. 2 to 5;

[0036] FIGURE 7, in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 6, the hemostatic device being shown in a first configuration;

[0037] FIGURE 8, in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 7, the hemostatic device being shown in a second configuration;

[0038] FIGURE 9, in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 8, the hemostatic device being shown in a third configuration;

[0039] FIGURE 10, in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 9, the hemostatic device being shown in a fourth configuration; [0040] FIGURE 1 1 , in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 10, the hemostatic device being shown in the third configuration;

[0041] FIGURE 12, in a top plan view, illustrate the hemostatic device shown in FIGS. 2 to 1 1 , the hemostatic device being shown in a fifth configuration;

[0042] FIGURE 13, in a side cross-sectional view, illustrates the hemostatic device shown in FIGS. 2 to 12 with parts removed;

[0043] FIGURE 14, in a partial side cross-sectional view, illustrates the hemostatic device shown in FIGS. 2 to 13 with parts removed;

[0044] FIGURE 15, in a side cross-sectional view, illustrates the hemostatic device shown in FIGS. 2 to 14;

[0045] FIGURE 16, in a partial side cross-sectional view, illustrates the hemostatic device shown in FIGS. 2 to 15;

[0046] FIGURE 17, in a perspective view, illustrates a hemostatic device in accordance with yet another embodiment of the present invention;

[0047] FIGURE 18, in a perspective partially exploded view, illustrates the hemostatic device shown in FIG. 17;

[0048] FIGURE 19, in a perspective partial cross-sectional view, illustrates the hemostatic device shown in FIGS. 17 and 18; [0049] FIGURE 20, in a partial perspective cross-sectional view, illustrates the hemostatic device shown in FIGS. 17 to 19 with a detachable strap attachment thereof in the process of being attached;

[0050] FIGURE 21 , in a partial perspective cross-sectional view, illustrates the hemostatic device shown in FIGS. 17 to 20 with the detachable strap attachment thereof attached;

[0051] FIGURE 22, in a perspective view, illustrates the hemostatic device shown in FIG. 1 ;

[0052] FIGURE 23, in an alternative perspective view, illustrates the hemostatic device shown in FIG. 22;

[0053] FIGURE 24, in a top plan view, illustrates the hemostatic device shown in FIGS. 22 and 23; and

[0054] FIGURE 25, in a partial top plan view, illustrates the hemostatic device shown in FIGS. 22 to 24.

DETAILED DESCRIPTION

[0055] Referring to FIG. 1 , there is shown a hemostatic device 10" in accordance with an embodiment of the present invention. The hemostatic device 10" is usable for substantially hemostatically sealing a percutaneous puncture (not shown in the drawings) in a blood vessel (not shown in the drawings) of a patient 12, only part of which is seen in FIG. 1 . The hemostatic device 10" is attachable to the patient 12 using a pair of straps 14. For example, the hemostatic device 10" is attachable in register with a percutaneous puncture in a leg 1 1 of the patient 12. Any suitable straps 14 are usable. For example the straps 14 are stretchable and of the elongated type including patches of complementary miniature hook and loop materials (such as Velcro (TM)) longitudinally spaced apart from each other at each end thereof. Therefore, each end of each strap can be folded onto itself (and around attachment elements part of the hemostatic device 10" and described in further details hereinbelow) and secured in this configuration using the patches of complementary miniature hook and loop materials. Other manners of forming loops at the ends of the straps 14 are also within the scope of the invention. The present documents describes 3 hemostatic devices 10, 10' and 10" that are similarly securable to the patient 12.

[0056] As seen for example in FIG. 2 in an exploded view, the hemostatic device 10 includes a device body 16 and a strap attachment assembly 18. The device body 16 includes a compression portion 22 defining a compression surface 24 for compressing against the patient 12 and a strap attachment assembly mounting portion 28 provided typically substantially opposed to the compression surface 24. In this case, the compression surface 24 forms the "bottom" part of the device body 16, while the strap attachment assembly mounting portion 28 forms the "top" portion of the device body 16. The strap attachment assembly 18 is mounted to the strap attachment assembly mounting portion 28, as seen for example in FIG. 4. The compression surface may be compressed directly against the skin of the patient 12, or against another element that itself is in contact with the skin of the patient 12.

[0057] In this document, directional terminology is used to facilitate description of the hemostatic device 10. Terms such a "top", "underside" and others refer to an orientation in which the compression surface 24 faces downwardly. However, the hemostatic device 10 is usable in any other suitable orientation. Also, the term "substantially" is used throughout this document to indicate variations in the thus qualified terms. These variations are variations that do not materially affect the manner in which the invention works and can be due, for example, to uncertainty in manufacturing processes or to small deviations from a nominal value that do not cause significant changes to the invention. These variations are to be interpreted from the point of view of the person skilled in the art.

[0058] Returning to FIG. 2, the strap attachment assembly 18 includes first and second strap attachment elements 44 and 46. The first strap attachment element 44 includes a first attachment element body 50 and substantially opposed first element first and second attachments 52 and 54 extending therefrom, either integrally as in the embodiment of the invention shown in FIG. 2, or in a detachable manner as described in further details hereinbelow. The first element first and second attachments 52 and 54 are provided for attaching a first strap 14 (not shown in FIG. 2) from the pair of straps 14 thereto. The second strap attachment element 46 includes a second attachment element body 68 and substantially opposed second element first and second attachments 70 and 72 extending therefrom, either integrally or in a detachable manner, for attaching a second strap 14 (not shown in FIG. 2) from the pair of straps 14 thereto.

[0059] The first element first and second attachments 52 and 54 and the second element first and second attachments 70 and 72 are configured for attaching the straps 14 thereto, and they, or components having the same function, are also referred to as "strap attachments" in the present documents. For example, as seen in FIG. 2, the first element first and second attachments 52 and 54 and the second element first and second attachments 70 and 72 each define an aperture 101 for receiving the straps 14 thereinto, for example by looping an end of one of the straps 14 therearound and securing the thus looped strap 14 to itself so that the straps 14 form closed loops in which the first element first and second attachments 52 and 54 and the second element first and second attachments 70 and 72 are received.

[0060] The first and second strap attachment elements 44 and 46 are rotatable independently from each other relative to the device body 16. The rotation of the first and second strap attachment elements 44 and 46 is for example limited to a predetermined angular range of rotation that does not include a complete circle. Also, in some embodiments, the first and second strap attachment elements 44 and 46 are coupled to each other so that while they remain independently rotatable over the predetermined angular range of rotation, it is possible that at the ends of this predetermined angular range of rotation, rotation of one of the first and second strap attachment elements 44 and 46 causes a corresponding rotation of the other one of the first and second strap attachment elements 44 and 46.

[0061] In a specific embodiment of the invention, as shown in the drawings, the first strap attachment element 44 is rotatable over a first a predetermined angle range (for example over 30 degrees) relative to the device body 16, as shown in the sequence of FIGS. 7, 8 and 9. The second strap attachment element 46 is rotatable over a second predetermined angle range (for example over 75 degrees) relative to the first strap attachment element 44, as shown in the sequence of FIGS. 10, 1 1 and 12, which allows rotation relative to the device body 16. However, in alternative embodiments of the invention, the first and second strap attachment elements 44 and 46 are rotatable respectively over first and second predetermined angle ranges relative to the device body 16. In yet other embodiments of the invention, the first and second strap attachment elements 44 and 46 are freely rotatable relative to the device body 16 without limit to the angular positions relative thereto. The independence of rotation of the first and second strap attachment elements 44 and 46 causes at least one of the first element first and second attachments 52 and 54 and at least one of the second element first and second attachments 70 and 72, which can be designated generally as being strap attachments, to be rotatable independently from each other relative to the device body 16.

[0062] The first and second strap attachment elements 44 and 46 are rotatable about a common attachment element rotation axis 48 (seen in FIG. 4) relative to the device body 16. Typically, but not necessarily, the attachment element rotation axis 48 is substantially perpendicular to the compression surface 24, as seen in FIG. 4. However, in alternative embodiments (not shown in the drawings), the first and second strap attachment elements 44 and 46 are rotatable independently from each other relative to the device body 16 about respectively first and second attachment element rotation axes. The embodiment shown in the drawings corresponds to the case in which the first and second attachment element rotation axes are collinear, and therefore form a common attachment element rotation rotation axis 48.

[0063] Returning to FIG. 2, the device body 16 includes a substantially rigid device body core 20 to which the compression portion 22 is mounted. In some embodiments of the invention, the compression portion 22 includes a gel mounted to the device body core 20, the gel being less rigid than the device body core 20. For example, the device body core 20 is elongated and has a substantially trapezoidal transversal cross-sectional configuration, with rounded vertexes, in a plane parallel to the compression surface 24. However, in alternative embodiments of the invention, the device body core 20 has any other suitable shape. The device body core 20 is made of a substantially rigid material, such as substantially rigid plastic. In some embodiments of the invention, to provide a relatively light but nevertheless rigid device body core 20 with minimal use of material, device body core 20 is hollow and provided with ribs 30 reinforcing the structure of the device body core 20, the ribs 30 defining a central recess 32 of substantially cylindrical shape and concentric with the attachment element rotation rotation axis 48. For example, the ribs 30 include concentric cylindrical ribs with generally radially extending planar ribs extending therebetween, in a spider weblike shape.

[0064] The compression portion 22 encloses the device body core 20 and defines a compression element peripheral wall 26 extending from the compression surface 24 towards the strap attachment assembly mounting portion 28. In some embodiments of the invention, as seen in FIG. 6, the compression surface 24 has a substantially trapezoidal shape, which has surprisingly been found advantageous in conforming to the anatomy of the inguinal area of the upper legs 1 1 of patients 12. The compression portion 22 is typically made of a relatively soft material, when compared to the device body core 20, to provide at least a partial penetration of the compression portion 22 in the puncture, and to increase patient comfort. However, any other suitable material, such as a material having a rigidity equal or larger than the rigidity of the device body core 20 is usable in other embodiments. More generally, in a typical embodiment, the compression surface 24 defines substantially opposed compression surface first and second end edges 29 and 31 and compression surface side edges 33 and 35 extending therebetween, the compression surface first end edge 29 being shorter than the compression surface second end edge 31 . The edges 29, 31 , 33 and 35 are typically substantially rectilinear or with a slight curvature and merge into each other with rounded vertexes. However, any other suitable shape for the compression surface 24 is usable in alternative embodiments of the invention.

[0065] Returning to FIG. 2, the strap attachment assembly mounting portion 28 is now described in further details. Although a specific strap attachment assembly mounting portion 28 is described hereinbelow, in alternative embodiments of the invention, any other structure that allows mounting of the strap attachment assembly mounting portion 28 to the device body 16 and allow rotation of the first and second strap attachment elements 44 and 46 relative thereto are usable. Also, the features of the hemostatic device 10 unrelated to rotation are also usable in embodiments that do not include rotatable first and second strap attachment elements 44 and 46.

[0066] The strap attachment assembly mounting portion 28 includes a flange 34 extending substantially radially outwardly from the device body core 20 opposed to the compression surface 24 and a receiving portion peripheral wall 36 extending generally perpendicularly therefrom, again in a direction leading away from the compression surface 24. The receiving portion peripheral wall 36 is substantially cylindrical and defines a receiving portion peripheral wall free end 37 opposed to the device body core 20.

[0067] A pair of peripheral wall tongues 38 extend from the receiving portion peripheral wall 36 adjacent the receiving portion peripheral wall free end 37, first radially outwardly and then towards the compression surface 24. The peripheral wall tongues 38 are substantially J-shaped and resiliently deformable.

[0068] A pair of peripheral wall flanges 40 extend radially outwardly from the receiving portion peripheral wall 36 between the peripheral wall tongues 38. Each peripheral wall flange 40 is circumferentially substantially U-shaped with flared ends and defines a central segment 41 and opposed ends segments 43. The central segment 41 is substantially in register with the flange 34 and substantially coplanar therewith. The end segments 43 have inverted L shapes and extend from the central segment 41 first towards the receiving portion peripheral wall free end 37 and then parallel to the receiving portion peripheral wall free end 37. Peripheral wall flange ribs 42 are provided substantially equally spaced from each other on the side of the central segment 41 facing the receiving portion peripheral wall free end 37.

[0069] The first and second attachment element bodies 50 and 68 are typically removably mountable to the device body 16. The first attachment element body 50 defines a first element body top wall 56 and a first element body peripheral wall 58 extending at the periphery therefrom in a direction leading towards the compression surface 24. The first element body peripheral wall 58 defines a first element body peripheral wall free end 57 opposed to the first element body top wall 56. Two first element body attachment flanges 59 extend inwardly from the first element body peripheral wall 58 adjacent the first element body peripheral wall free end 57, as seen in FIG. 3.

[0070] The first element body top wall 56 defines a first element body top wall central portion 61 having a substantially bowl shape (better seen in FIG. 2) with a first element body central shaft 60 (better seen in FIG. 3) of generally cylindrical and hollow configuration extending towards the compression surface 24 at the center thereof. Returning to FIG. 2, peripherally to the first element body top wall central portion 61 , the first element body top wall 56 defines a substantially annular first element body groove 62 extending generally towards the compression surface 24 and defining a pair of first element body groove slots 64 (only one of which is seen in FIG. 2, extending through the first element body top wall 56. The first element body groove slots 64 are provided circumferentially between the first element first and second attachments 52 and 54. To define the first element body groove 62, the first element body top wall 56 defines a substantially annular groove defining protrusion 63, seen in FIG. 3, extending from the underside of the first element body top wall 56 towards the compression surface 24. Peripherally to the first element body groove 62, in register with the first element first and second attachments 52 and 54, a pair of first element body peripheral slots 66 extending through the first element body top wall 56 are provided (one of which is shown in FIG. 3). Motion limiting protrusions 65 (one of which is shown in FIG. 3) are provided on the inside of the first element body peripheral wall 58, between the first element body peripheral slots 66. In some embodiments of the invention, reinforcing ribs 67 are provided on the underside of the first element body top wall 56.

[0071] Returning to FIG. 2, the first element first and second attachments 52 and 54 are substantially opposed to each other at about 180 degrees and substantially U-shaped and extend from the first attachment element body 50 at an angle directed slightly away from the compression surface 24. The first element first and second attachments 52 and 54 each include a first element attachment outer segment 53 and a pair of first element attachment support segments 49 and 51 extending between the first element attachment outer segment 53 and the first attachment element body 50. For example, the first element attachment support segments 49 and 51 of the first element first attachment 52 are collinear with the first element attachment support segments 49 and 51 of the first element second attachment 54. The apertures 101 of the first element first and second attachments 52 and 54 are thus each defined by the first attachment element body 50, a pair of first element attachment support segments 49 and 51 , and a first element attachment outer segment 53. The first element attachment support segments 49 and 51 typically curve away from the compression surface 24 so that the first element attachment outer segment 53 is above the first attachment element body 50.

[0072] The second attachment element body 68 defines a second element body top wall 74 and a second element body peripheral wall 76 extending at the periphery thereof in a direction leading towards the compression surface 24. The second element body peripheral wall 76 defines a second element body peripheral wall free end 77 opposed to the second element body top wall 74. A second element body central aperture 78 extends through the second element body top wall 74 substantially at the center thereof. The second element body top wall 74 defines a substantially bowl-shaped second element body top wall central portion 79, extending radially outwardly from the second element body central aperture 78, and a substantially flat and annular second element body top wall peripheral portion 75 extending radially outwardly therefrom. In some embodiments of the invention, reinforcing ribs 90 are provided on the underside of the second element body top wall 74, as seen in FIG. 3. The second element body central aperture 78 is usable to secure the hemostatic device 10 to a conventional stand (not shown in the drawings) that is usable in combination with the straps 14, or solely, to secure the hemostatic device 10 to the patient 12.

[0073] The second element body peripheral wall 76 defines a pair of circumferentially spaced apart second element body peripheral wall gaps 80 in which second element body tongues 82 are provided. The second element body tongues 82 extend from the second element body top wall 74 and are J-shaped, with a tongue free end 84 that flares radially outwardly. The second element body tongues 82 are resiliently deformable and so as to allow radial movements of the tongue free ends 84 relative to the second element body peripheral wall 76. [0074] The second element first and second attachments 70 and 72 are substantially opposed to each other and substantially U-shaped and extend from the second attachment element body 68 at an angle directed away from the compression surface 24. The second element first and second attachments 70 and 72 each include a second element attachment outer segment 85 and a pair of second element attachment support segments 86 and 88 extending between the second element attachment outer segment 85 and the second attachment element body 68. The second element attachment support segments 86 and 88 typically curve away from the compression surface 24 so that the second element attachment outer segment 85 are above the second attachment element body 68.

[0075] In some embodiments of the invention, second element first and second attachments 70 and 72 are asymmetrical so that the second element attachment support segments 86 and 88 are angled at different angles relative to the second element attachment outer segments 85. Also, the second element attachment outer segments 85 are in some embodiments not parallel to each other, in opposition to the first element attachment outer segments 53. This configuration may facilitate attachment of the hemostatic device 10 to some patients 12. The apertures 101 of the second element first and second attachments 70 and 72 are thus each defined by the second attachment element body 68, a pair of second element attachment support segments 86 and 88, and a second element attachment outer segment 85.

[0076] FIG. 2 illustrates the hemostatic device 10 with the device body 16, the first strap attachment element 44 and the second strap attachment element 46 detached from each other. When in use, however, the device body 16, the first strap attachment element 44 and the second strap attachment element 46 are attached to each other as seen for example in FIGS. 4, 5 and 6 and further described hereinbelow.

[0077] Referring to FIG. 13, the first strap attachment element 44 is attached to the strap attachment assembly mounting portion 28. To that effect, as better seen in FIG. 14, the receiving portion peripheral wall 36 is inserted between the groove defining protrusion 63 and the first element body peripheral wall 58. Typically, the groove defining protrusion 63 abuts against the flange 34 and is substantially fittingly received inside the receiving portion peripheral wall 36 so that the first strap attachment element 44 is rotatable relative to the device body 16 while having minimal transversal translation movement relative thereto. This effect is reinforced by having the first element body central shaft 60 partially inserted in the central recess 32, as seen in FIG. 13. Returning to FIG. 14, to prevent accidental removal of the first strap attachment element 44 from the device body 16, the peripheral wall tongues 38 are received in the space defined between the first element body attachment flanges 59 and the first element body top wall 56. Although not seen explicitly in the drawings, the motion limiting protrusions 65 are received in register with a respective one of the peripheral wall flanges 40. Attachment of the first strap attachment element 44 to the device body 16 is performed by pressing the first strap attachment element 44, and more specifically the first element body attachment flanges 59, against the peripheral wall tongues 38, which then deform and allow achieving the configuration seen in FIGS. 13 and 14. Depressing the peripheral wall tongues 38 allows removal of the first strap attachment element 44 from the device body 16

[0078] Rotation of the first strap attachment element 44 relative to the device body 16 is limited by the dimensions of the peripheral wall flanges 40 through interference with the motion limiting protrusions 65 and by the dimensions of the first element body attachment flanges 59 and of the peripheral wall flanges 40 that abut against each other at the end of the range of motion.

[0079] As seen in FIG. 15, the second strap attachment element 46 is attached to the first strap attachment element 44. To that effect, as better seen in FIG. 16, the second element body tongues 82 are each received in a respective one of the first element body groove slots 64. Interference between the second element body tongue 82 and the first element body groove slots 64 limits the range of motion of the second strap attachment element 46 relative to the first strap attachment element 44. The shape of the reinforcing ribs 90 are provided on the underside of the second element body top wall 74 conforms to the shape of the upper surface of the first element body top wall 56 so that the reinforcing ribs 90 can abut against the second element body top wall 74 when the second strap attachment element 46 is attached to the first strap attachment element 44 to provide a robust assembled hemostatic device 10. Attachment of the second strap attachment element 46 to the first strap attachment element 44 is performed by pressing the second strap attachment element 46 against the first strap attachment element 44 with the second element body tongue 82 and the first element body groove slots 64 in register with each other. This pressing movement deforms the second element body tongues 82 that are then inserted in the first element body groove slots 64 and which snap back to an unconstrained position when full insertion is completed. The shape of the second element body tongues 82 prevents accidental withdrawal of the second element body tongues 82 from the first element body groove slots 64 as the second element body tongues 82 must be deformed to allow such withdrawal.

[0080] In use, to attach the hemostatic device 10 to a patient 12, the compression surface 24 is positioned adjacent a percutaneous puncture, with the narrow end of the compression surface 24 directed towards the feet of the patient 12. Then, the straps 14 are used to secure the hemostatic device 10 to the patient. Free rotation of the first and second strap attachment elements 44 and 46 provides automatic adjustment of the hemostatic device 10 to the morphology of the patient 12. The limited range of this free motion ensures that the first and second strap attachment elements 44 and 46 are nevertheless oriented properly for securing the hemostatic device 10 to the patient 12. Finally, the surgical instrument that was inserted in the percutaneous puncture can be removed and tension on the straps 14 can be adjusted to provide the desired hemostatic effect.

[0081] FIGS. 17 to 21 illustrate a hemostatic device 10' in accordance with an alternative embodiment of the present invention. The hemostatic device 10' is similar to the hemostatic device 10 described hereinabove an only the differences therebetween are described herein.

[0082] The hemostatic device 10' includes detachable strap attachments 100, performing the same function as the the first element first and second attachments 52 and 54 and the second element first and second attachments 70 and 72, that are removably attachable to an alternative strap attachment assembly 18' that includes alternative first and second strap attachment elements 44' and 46'. The first and second strap attachment elements 44' and 46' are configured so that the detachable strap attachments 100 can be either attached thereto (as seen in FIG. 17) or detached therefrom (as seen in FIG. 18). It should be noted that in alternative embodiments of the invention, only some of the strap attachments are detachable from the first and second strap attachment elements 44' and 46'.

[0083] To that effect, the first and second strap attachment elements 44' and 46' include respectively a substantially annular central portion 56', only one of which is visible in FIGS. 17 to 21 , and a pair of substantially opposed first and second element attachment receiving portions 53' and 85' extending therefrom for removably attaching the strap attachments 100 thereto. The attachment receiving portions 53' and 85' each define a respective detachable strap attachment receiving portion 102. The four detachable strap attachment receiving portions 102 are typically identical to each other so that identical detachable strap attachments 100 can be used.

[0084] As seen for example in FIG. 18, on which only reference numerals related to one of the detachable strap attachment receiving portions 102 are indicated for clarity reasons, the detachable strap attachment receiving portions 102 each define a receiving portion upper surface 103, an inwardmost portion 1 10 and an outwardmost portion 1 1 1 . The inwardmost and outwardmost portions 1 10 and 1 1 1 are inwardmost and outwardmost relative to the longitudinal axis of the hemostatic device 10'. The inwardmost portion 1 10 defines part of the receiving portion upper surface 103 and the outwardmost portion 1 1 1 typically takes the form of a wall extending generally perpendicular to the receiving portion upper surface 103.

[0085] A pair of receiving portion apertures 104 are defined between inwardmost and outwardmost portions 1 10 and 1 1 1 . The receiving portion apertures 104 are longitudinally spaced apart along the first and second attachment receiving portions 53' and 85' and extend therethrough from the receiving portion upper surface 103. The receiving portion apertures 104 are separated from each other by a receiving portion ridge 106 extending between the inwardmost and outwardmost portions 1 10 and 1 1 1 . Each of the receiving portion apertures 104 is in register with a receiving portion ledge 108 that extends partially across the receiving portion apertures 104 from the outwardmost portion 1 1 1 towards the inwardmost portions 1 10 and obstructs part of the receiving portion apertures 104. The receiving portion ledge 108 is offset downwardly relative to the receiving portion upper surface 103 and a gap 121 is defined between the receiving portion ledge 108 and the inwardmost portion 1 10.

[0086] Each detachable strap attachments 100 includes a strap receiving portion 1 12 and an attachment portion 1 14. The strap receiving portion 1 12 is typically loop-shaped and defines an aperture 1 16 extending therethrough for receiving one of the straps 14, as described in further details hereinbelow. The attachment portion 1 14 includes a pair of substantially parallel strap attachment tongues 1 18 insertable in a respective one of the receiving portion apertures 104 of the detachable strap attachment receiving portions 102. Each strap attachment tongue 1 18 typically extends integrally from the strap receiving portion 1 12 and defines a tongue distal end 120 opposed to the strap receiving portion 1 12. Each strap attachment tongue 1 18 defines a tongue distal recess 122 adjacent the tongue distal end 120 so that the strap attachment tongue 1 18 is thinner adjacent the tongue distal end 120 relative to portions of the strap attachment tongue 1 18 adjacent the tongue distal recess 122. The tongue distal recess 122 extends downwardly from the top of the detachable strap attachments 100. Also, the underside of each strap attachment tongue 1 18 is provided with a tongue ridge 124 (seen in FIGS. 20 and 21 ) spaced apart from the tongue distal recess 122, closer to the strap receiving portion 1 12, and extending perpendicular to the strap attachment tongue 1 18.

[0087] Attachment of each detachable strap attachment 100 to one of the detachable strap attachment receiving portions 102 is performed as follows. First, each strap attachment tongue 1 18 is inserted in a respective one of the receiving portion apertures 104 with the receiving portion ridge 106 therebetween at an oblique angle, from the top, as seen in FIG. 20, until the tongue distal recess 122 is in register with the inwardmost portion 1 10. Then, the detachable strap attachment 100 is pivoted until the inwardmost portion 1 10 is received in the tongue distal recess 122 and the outwardmost portion 1 1 1 is received in the tongue ridge 124, as seen in FIG. 21 . This action also pushes the tongue distal end 120 through the gap 121 .

[0088] The receiving portion apertures 104 and strap attachment tongue 1 18 are complementarily shaped to allow for a relatively tight fit of the strap attachment tongue 1 18 in the receiving portion apertures 104. In some embodiments, the receiving portion apertures 104 and strap attachment tongue 1 18 snugly fit to each other and are resiliently deformable so that they snap together when the detachable strap attachment 100 is attached to the detachable strap attachment receiving portions 102. However, in other embodiments, no such snapping action is present. Detachment of the strap attachment tongue is performed by reversing these steps.

[0089] The detachable strap attachment 100 is thus movable between a locked position, shown for example in FIG. 21 , in which the detachable strap attachment 100 is secured to the remainder of the first and second strap attachment elements 44' and 46', and an unlocked position, shown for example in FIG. 20, in which the detachable strap attachment 100 is freely movable away from the first and second strap attachment elements 44' and 46', the detachable strap attachment 100 pivoting relative to the to the remainder of the first and second strap attachment elements 44' and 46' about an attachment pivot axis 57, shown in FIG. 20, when the detachable strap attachment 100 moves between the locked and unlocked positions. Typically, the attachment pivot axis 57 is substantially parallel to the compression surface 24, which improves the locking action to reduce risks of accidental detachment of the detachable strap attachment 100. [0090] In use, the straps 14 can be first secured each to a pair of detachable strap attachments 100 by forming a loop around the strap receiving portion 1 12. One of these detachable strap attachments 100 is then attached to the remainder of the hemostatic device 10'. Afterwards, or before, the strap 14 is adjusted so that the length thereof that is between two detachable strap attachments 100 is suitable for securing the hemostatic device 10' to the patient with a suitable tension in the strap 14. Then, the other detachable strap attachment 100 is also attached to the remainder of the hemostatic device 10'. The same operations are repeated for the other strap 14. Since the straps 14 pull the hemostatic device 10' towards the patient, the detachable strap attachments 100 are prevented from being removed accidentally from the hemostatic device 10' by the tension in the straps 14.

[0091] FIGS. 22 to 25 illustrate the hemostatic device 10". The hemostatic device 10" is similar to the hemostatic device 10' and only significant differences therebetween are described hereinbelow. The hemostatic device 10" differs from the hemostatic device 10' in at least two aspects. Referring to FIG. 24, first, the hemostatic device 10" includes a device body core 20" that defines a device body aperture 30" extending therethrough and reaching the gel forming the compression portion 22, in the portion defining the compression surface 24. The first and second strap attachment elements 44" and 46" are configured to provide access to the device body aperture 30" when mounted to the device body of the hemostatic device 10"', for example by having the central portions thereof superposed and each defining a respective central portion aperture 230 and 232 in register with the device body aperture 30". Also, the manner in which the strap attachments 100" are secured to the remainder of the hemostatic devicel O" is different, as detailed hereinbelow. [0092] The device body aperture 30" and the central portion apertures 230 and 232 allow insertion of an ultrasound or Doppler probe in the device body aperture 30" so that the probe can be used to monitor blood flow during the compression of an artery with the hemostatic device 10". Typically, the compression should be large enough to prevent leaks of blood while allowing circulation of blood in the artery. Monitoring blood flow or artery lumen shape and/or dimensions using the probe allows adjustment of tension in the straps 14 to achieve that condition. In some embodiments, a substantially annular flange 233 is provided in the device body aperture 30" adjacent the compression portion 22. The flange 233 defines an access aperture 231 that allows access to the gel of the compression portion 22.

[0093] Referring to FIGS. 22 and 23, similarly to the hemostatic device 10', in the hemostatic device 10", the first and second strap attachment elements 44" and 46" each define a pair of detachable strap attachment receiving portions 102" each for removably receiving one of the strap attachments 100". The detachable strap attachment receiving portions 102" each define opposed strap attachment receiving portion upper and lower surfaces 203 and 205, the strap attachment receiving portion lower surface 205 facing towards the compression surface 24. The strap attachments 100" each define upper and lower tongues 208 and 210 engaging respectively the strap attachment receiving portion upper and lower surfaces 203 and 205 when the strap attachments 100" are attached to the detachable strap attachment receiving portions 102". For example, as seen in FIG. 23, the strap attachments 100 define a pair of upper tongues 208 protruding from the remainder thereof with a lower tongue 210 provided therebetween. The upper and lower tongues are received in a respective upper and lower recesses 212 and 214 provided respectively in the strap attachment receiving portion upper and lower surfaces 203 and 205. [0094] Referring to FIG. 25, in some embodiments, a protrusion 218 extends from each of the upper tongues 208 and engages a correspondingly shaped receiving recess 216 provided at the extremity of the upper recesses 212. Also, the lower tongue 210 forms a resiliently deformable latch for selectively locking the strap attachments 100" to the detachable strap attachment receiving portions 102" in a locked position. To that effect, the lower tongue 210 is substantially J-shaped and terminates with a protrusion 219 extending upwardly and defining a ledge 220 in register with and spaced apart from the remainder of the lower tongue 210. The ledge 220 is typically relatively small and engages the strap attachment receiving portion upper surface 203 when the strap attachment 100" is attached to the detachable strap attachment receiving portions 102". Thus, the action of the protrusions 218 and 219 maintain the strap attachment 100" locked to the detachable strap attachment receiving portions 102" unless the strap attachment 100" is pivoted relative to the detachable strap attachment receiving portions 102", which is only allowed if an intended user depresses the lower tongue 210 so that the ledge 220 disengages from the strap attachment receiving portion upper surface 203. Then, pivotal movement of the strap attachment 100" similarly to the hemostatic device 10' can be made.

[0095] The reader skilled in the art will readily understand that characteristics of the hemostatic devices 10, 10' and 10" that are compatible with each other can be combined in any suitable manner.

[0096] Although the present invention has been described hereinabove by way of preferred embodiments thereof, it can be modified, without departing from the spirit and nature of the subject invention as defined in the appended claims.

Claims

WHAT IS CLAIMED IS:

1 . A hemostatic device attachable to a patient with first and second straps, said hemostatic device comprising:

a device body, said device body including a compression portion defining a compression surface for compressing against said patient and a strap attachment assembly mounting portion;

a strap attachment assembly mounted to said strap attachment assembly mounting portion, said strap attachment assembly including a first strap attachment element, said first strap attachment element including a first attachment element body and substantially opposed first element first and second attachments extending therefrom, said first element first and second attachments being configured for attaching said first strap thereto;

a second strap attachment element, said second strap attachment element including a second attachment element body and substantially opposed second element first and second attachments extending therefrom, said second element first and second attachments being configured for attaching said second strap thereto;

wherein said first and second strap attachment elements are rotatable independently from each other relative to said device body.

2. A hemostatic device as defined in claim 1 , wherein said first and second strap attachment elements are rotatable independently from each other relative to said device body about respectively first and second attachment element rotation axes. A hemostatic device as defined in claim 2, wherein said first and second attachment element rotation axes are substantially perpendicular to said compression surface.

A hemostatic device as defined in claim 2 or 3, wherein said first and second attachment element rotation axes are substantially collinear.

A hemostatic device as defined in any one of claims 1 to 4, wherein said strap attachment assembly mounting portion is substantially opposed to said compression surface.

A hemostatic device as defined in any one of claims 1 to 5, wherein said compression surface is substantially trapezoidal.

A hemostatic device as defined in any one of claims 1 to 6, wherein said compression surface defines substantially opposed compression surface first and second end edges and compression surface side edges extending therebetween, said compression surface first end edge being shorter than said compression surface second end edge.

A hemostatic device as defined in any one of claims 1 to 7, wherein said device body includes a substantially rigid device body core and said compression portion includes a gel mounted to said device body core, said gel being less rigid than said device body core.

A hemostatic device as defined in claim 8, wherein

said device body core defines a device body aperture extending therethrough and reaching said gel; and said first and second strap attachment elements are configured to provide access to said device body aperture when mounted to said device body.

10. A hemostatic device as defined in any one of claims 1 to 9, wherein said first element first attachment is removably attachable to said first

attachment element body.

1 1 . A hemostatic device as defined in any one of claims 1 to 10, wherein said second element first attachment is removably attachable to said second attachment element body.

12. A hemostatic device as defined in claim 10, wherein said first element first attachment is movable between a locked position in which said first element first attachment is secured to said first attachment element body and an unlocked position in which said first element first attachment is freely movable away from said first attachment element body, said first element first attachment pivoting relative to said first attachment element body about an attachment pivot axis when said first element first attachment moves between said locked and unlocked positions.

13. A hemostatic device as defined in claim 12, wherein said attachment pivot axis is substantially parallel to said compression surface.

14. A hemostatic device as defined in claim 12 or 13, wherein said first element first attachment includes a resiliently deformable latch for selectively locking said first element first attachment to said first attachment element body when said first element first attachment is in said locked position.

15. A hemostatic device as defined in any one of claims 10 to 14, wherein: said first attachment element body defines a first element attachment receiving portion for removably attaching said first element first attachment thereto, said first element attachment receiving portion defining opposed attachment element receiving portion upper and lower surfaces, said attachment element receiving portion lower surface facing towards said compression surface;

said first element first attachment defining upper and lower tongues engaging respectively said attachment element receiving portion upper and lower surfaces when said first element first attachment is attached to said first element attachment receiving portion.

16. A hemostatic device as defined in any one of claims 10 to 14, wherein said first and second attachment element bodies each include a substantially annular central portion and a pair of substantially opposed attachment receiving portions extending therefrom.

17. A hemostatic device as defined in claim 16, wherein

said device body includes a substantially rigid device body core and said compression portion includes a gel mounted to said device body core, said gel being less rigid than said device body core;

said device body core defines a device body aperture aperture extending therethrough and reaching said gel; and

said central portions are superposed and each define a respective central portion aperture in register with said device body aperture.

18. A hemostatic device as defined in any one of claims 1 to 17, wherein said first element first attachment defines an aperture for receiving said first strap therethrough.

19. A hemostatic device as defined in any one of claims 1 to 18, wherein said first and second attachment element bodies are removably mountable to said device body.

20. A hemostatic device attachable to a patient with first and second straps, said hemostatic device comprising:

a device body, said device body including a compression portion defining a compression surface for compressing against said patient and a strap attachment assembly mounting portion; and

a strap attachment assembly mounted to said strap attachment assembly mounting portion, said strap attachment assembly including four strap attachments for attaching said first and second straps thereto, at least two of said four strap attachments being rotatable independently from each other relative to said device body.