Abstract:
A hand/wrist positioning splint to keep the hand positioned for radial artery access and to permit application of a hemostasis band to apply pressure to the radical artery puncture site to permit closing of said puncture site, is provided. The splint includes a rigid structure ( 12 A) for positioning a patient&#39;s hand, and wrist in a fixed hyper-extended state, the structure ( 12 A) having a distal end surface to support a patient&#39;s hand, and palm up, the end surface extends downwardly from the wrist position to make a first fixed angle with a horizontal plane. The rigid structure also has a wrist/forearm support surface also extending downwardly from the wrist position to make a second fixed angle with a horizontal plane. Straps ( 16 A) are provided for securing the hand, and the wrist/forearm in fixed position on the rigid structure. An opening ( 20 A) in the wrist/forearm surface of the rigid support below the point of arterial access permits application of a hemostasis band to the arterial puncture site.

Description:
This application claims the benefit of provisional application 60/099,956 filed Sep. 11, 1998. 
    
    
     SUMMARY OF THE INVENTION 
     The present invention relates to devices for use during and after radial artery procedures. More particularly, the present invention is directed to a hand/wrist positioning splint that keeps the hand positioned for radial artery access, and a hemostasis band to apply pressure to the radial artery puncture site to permit closure of the site. Particular utility of the present invention is in radial artery procedures, e.g., intervention cardiology, diagnostic cardiology, radiology, etc., and other coronary/cardiac procedures; although other utilities are contemplated herein 
     In one aspect, the present invention provides a hand/wrist positioning splint that is shaped to position the hand and wrist in a hyperextended state during radial procedures and to keep the hand and wrist immobilized during the procedure. Advantageously, the splint of the present invention positions the hand and wrist in such a manner so as to extend the radial artery for simple, safe ingress during radial artery procedures. In the preferred embodiment, Velcro straps or suction cups are provided to ensure the immobility of the hand/wrist and to ensure the wrist splint does not move during the procedure. Also preferably, the splint is formed of biocompatable material that is presterilized. 
     In another aspect, the present invention provides a hemostasis band which is advantageously designed to apply pressure directly to the puncture wound site of the radial artery to prevent bleeding and permit closure of the wound. Also advantageously, the hemostasis band has features that permit sufficient pressure to be applied to the radial artery (so that the wound can close) while maintaining blood flow through the radial artery (or, for that matter, through the ulnar artery or venous system). Preferably, the hemostasis band is formed of biocompatable material that is presterilized and disposable for single-use applications. In yet another aspect of the present invention, the wrist splint and hemostasis band are provided in one integrally formed device. 
     It will be appreciated by those skilled in the art that although the following Detailed Description will proceed with reference being made to preferred embodiments, the present invention is not intended to be limited to these preferred embodiments. Other features and advantages of the present invention will become apparent as the following Detailed Description proceeds, and upon reference to the Drawings, wherein like numerals depict like parts, and wherein: 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an elevational view of one preferred embodiment of the splint of the present invention; 
     FIG. 2 is a side view of the splint of FIG. 1; 
     FIG. 2A is a cross-sectional view of the splint view taken along the lines  2 — 2  of FIG. 2; 
     FIG. 3 is a detailed end view of the splint of FIG. 1; 
     FIG. 3A is an end-on cross sectional view of the splint taken along the lines  3 — 3  of FIG. 3; 
     FIG. 4 is a side view of another embodiment of the splint of the present invention; 
     FIG. 5 is a side view of another embodiment of the splint of the present invention; 
     FIG. 6 is top view of the embodiment of FIG. 5; 
     FIG. 7 is an elevational view of the hemostasis band of the present invention; 
     FIG. 8 is an elevational view of one preferred embodiment of the buckle of the hemostsis band of the present invention; 
     FIG. 9 is a side view of the buckle of FIG. 8; 
     FIG. 10 is a side view of another preferred embodiment of the buckle of the hemostsis band of the present invention; 
     FIG. 11 is a side view of another preferred embodiment of the buckle of the hemostsis band of the present invention; 
     FIG. 12 is a side view of another preferred support pad of the hemostasis band of the present invention; and 
     FIG. 13 is an elevational view of another preferred embodiment of the wrist splint in combination with the hemostasis band of the present invention. 
     FIG. 14 is a side view of the most preferred form of the invention showing a patient&#39;s wrist held in position for a radial artery procedure. 
     FIGS. 15 and 16 are sectional views of the most preferred form of hemostasis band. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     FIGS. 1-3A depict various views of the wrist splint  10  of the present invention. Essentially, splint  10  comprises an elongated member  12 , having a proximal end  12  and a distal end  14 . Two or more straps  16  are provided, positioned on the distal  14  and proximal  12  ends to secure a patient&#39;s hand and wrist/forearm, respectively, to the splint  10 . In this embodiment, the splint is a solid, form-fitted, integrally molded piece. An indent  18  is formed on the proximal end to mate with the shape of a patient&#39;s wrist/forearm, as shown in FIG.  2 A. Preferably, member  12  is a one piece member integrally formed of foam rubber or other similar soft, pliable material. Although not shown in the drawings, a non-bending member of appropriate stiffness can be removably affixed to the bottom of member  12  to prevent any bending of member  12  during use. Of course, member  12  can be permanently affixed (to prevent bending) to an operating table, etc. without departing from the present invention. A cavity  20  is provided between the distal and proximal ends to facilitate attachment of a hemostasis band about the wrist (discussed more fully below) or other device used during a radial artery procedure. 
     Straps  16  can be any fixable member known in the art, or, as shown in FIG. 1, each strap  16  has a locking clasp  22  to vary the length of the strap  16  to fit the particular patient. It will be understood by those skilled in the art that the strap  16  shown in FIG. 1 is just one of a myriad of equivalent strap structures, for example, Velcro straps, elastic straps, etc., and all such equivalents are deemed within the scope of the present invention. Straps  16  are securely fastened (using epoxy, etc.) to member  12  for repeated use and strength. Alternatively, straps  16  are integrally molded with member  12  (not shown). 
     As shown in FIG. 2, member  10  is preferably formed with two distinct angles FIG. 3A and 26, formed about the wrist/hand joint location (i.e., formed about cavity  20 ). It is one object of the present invention to position a patient&#39;s hand and wrist in a hyperextended state, thereby increasing the ease for radial artery access and procedures. To that end, angles  24  and  26  permit the hand to be hyperextended to ensure proper exposure of the radial artery. In use, a patients hand, palm up, is placed on the distal end  14  of member  10  and strapped to the member  10  using strap  16 . Likewise, the wrist/forearm area is placed into indent  18  of member  10  and strapped in place. Angle  24  and  26  permit the radial artery to be at, or near, a greatest height above the hand and wrist (i.e., fully exposed). In the embodiment of FIGS. 1-3A, angles  24  and  26  are approximately 12 degrees and 25 degrees, respectively. 
     FIGS. 4 and 5 depict side views of another splint  30  and  40  of the present invention. Splint  30  and  40  are substantially similar to splint  10  (discussed above), except that, in these embodiments, member  32  and  42  are formed of a thin, stiff material (as opposed to the solid body member  12 , discussed above). These embodiments also differ in the extension angles for the wrist and hand, for use according to certain needs. Generally, the extension angle disclosed in the above-described embodiments is between 15 and 45 degrees, but can be modified for any angular extension. In other words, angle  34  and  36  are more pronounced than in the previous embodiment, to further hyperextend the hand/wrist. The embodiment of FIG. 5 is likewise modified. FIG. 6 is a top down view of the embodiment of FIG. 5, and is substantially similar to a top down view of FIG. 4, except for the respective angles, as discussed above. It should be noted that the splints of FIGS. 4 and 5 can be affixed to a non-flexing member (not shown), via attachment holes  48 , so that the splint  30 ,  40  does not bend or move. It is intended that the design can be attached to the table, bed or armboard using either a long strap or suction cups or a similar component. 
     The splint is formed of plastic or other suitable material that is biocompatable and that meets industry standards with regard to tissue and systemic reactivity, toxicity, cytotoxicity and non-pyrogenic. In addition, the splint should be formed of appropriate material that can be sterilized through acceptable means, e.g., ethylene oxide (ETO), gamma, e-beam, etc. Of course, the splint can also be provided in a presterilized state for single-use purposes. 
     In another aspect of the present invention, a radial hemostasis band is provided. As shown in FIG. 7, hemostasis band  50  essentially comprises a fixed foam block, a plurality of adjustable foam blocks, a connecting support pad  56 , a retaining strap  58 , clasp  72  and flexible members  60 . Retaining strap  58  is preferably a pliable member that is looped through one or more supporting pads  54 , via openings  68  in the support pads (FIG.  12 ). Also referring to FIG. 12, each support pad  54  and the connecting support pad  56  is slidably affixed to flexible members  60 , via slots  70 , so that the relative position of the pads can be easily adjusted (as shown by the arrow in FIG.  7 ). Flexible members  60  are preferably formed to permit bending in the radial direction (i.e., bending about a patient&#39;s wrist), but with sufficient mechanical strength to return to a relatively linear position when not in use. As shown in FIG. 8, flexible members  60  are attached to buckle  52 , either permanently or removably. Of course, flexible members could also be attached to the buckle  52  by a rotatable boss pin (not shown). The flexible member  60  can be cut shorter if it is too long for patient&#39;s with small (skinny) wrists. Cutouts exist in the flexible member  60  to facilitate cutting. To fasten the device about a patient&#39;s wrist, a clasp  72  (or other fastening means) is provided on the strap  58  that mates with an opening  68  in the connecting support pad  56  (FIG.  12 ). Once connected, radial adjustment can be achieved by sliding the connecting support pad  56 , thereby tightening the band around the patient&#39;s wrist. 
     One object of the hemostasis band  50  is to provide sufficient pressure to close the puncture site of the radial artery after a radial procedure, while maintaining blood flow through the ulnar artery and venous system. To that end, buckle  52  is provided. Side views of various preferred embodiments of the buckle  52  are shown in FIGS. 9-11. Buckle  52  has a generally trapezoidal shape with a bottom end that applies pressure to the radial artery. The bottom end can be flat  62 , slanted  64  or partially curved  66 , so that, once positioned, pressure is only applied to the radial artery without restricting other local veins and arteries. 
     As with the splint (discussed above), the hemostasis band is formed of plastic and other suitable material that is biocompatable and that meets industry standards with regard to tissue and systemic reactivity, toxicity, cytotoxicity and non-pyrogenic. In addition, the hemostasis band should be formed of appropriate material that can be sterilized through acceptable means, e.g., ethylene oxide (ETO), gamma, e-beam, etc. Of course, the hemostasis band can also be provided in a presterilized state for single-use purposes. 
     Turning now to FIG. 13, another aspect of the present invention is depicted. In this embodiment, the hemostasis band  84  and wrist splint  82 , as discussed above, are provided in one unitary structure  80 . In this embodiment, any combination of the previously disclosed wrist splints and hemostasis bands can be combined together, thus, FIG. 13 is only provided as an exemplary structure. Thus, the hemostasis bands of the previous embodiments are appropriately modified to be attached to the splint  82  by any suitable means. 
     In FIG. 14, there is illustrated the most preferred form of the invention which is based on a modification of the structure of FIG.  1 . In this FIG. 14 structure the elongated member  12 A is formed of a single hollow molded plastic shell having the shape illustrated. The upper surfaces  18 A are preferably slightly concave and are lied with foam  18 B for the patient&#39;s comfort. The straps  16 A are equivalent to straps  16  in FIG.  1 . The groove  20 A in the top of the base  12 A is similar in size and function to the groove  10  in FIG.  1 . 
     For use with the hand wrist support of the present invention the most preferred form of hemostasis band is illustrated in FIGS. 15 and 16 which are schematic illustrations of the preferred structure wherein the Velcro strap is shown in section at  100 , with the buckle illustrated at  102 . A fixed foam block  104  is secured to the strap below the buckle  102 . Also secured to the strap  100  adjacent the buckle is a rigid plastic strip  106  having a smooth surface. Carried on strip  106  is a pair of adjustable foam pads  108  which, by means of slits  110 , can be slid along the strip  106  to their desired operating position. 
     The pads  108  slide along the strip  106  and keep the strip  106  off the surface of the skin. Keeping the strip  106  off the skin&#39;s surface prevents the band from acting as a tourniquet, which might compromise ulnar artery flow and/or venous return. Possible positions for the support pads would be on the styloid process of the ulna and the lateral-posterior aspect of the head of the radius (see FIG.  17 ). The pads  108  should be positioned so that they do not occlude blood flow through the ulnar artery or the basilic and cephalic veins. 
     Modifications of the present invention are possible. For example the splint/hemostasis band/combined device can be formed of radio-lucent material suitable for x-ray analysis, etc., provided, of course, that such material meets the above-mentioned requirements for sterility. It should also be noted the present invention is equally applicable to either the left or right extremities. Further modifications will become apparent to those skilled in the art, and all such modifications are deemed within the scope of the present invention. 
     Advantages 
     Advantageously, the wrist splint of the present invention is shaped to position the hand and wrist in a hyperextended state during radial procedures and to keep the hand and wrist immobilized during the procedure. Also advantageously, the splint of the present invention positions the hand and wrist in such a manner so as to extend the radial artery for simple, safe ingress during radial artery procedures. In addition, the present invention provides a hemostasis band which is advantageously designed to apply pressure directly to the puncture wound site of the radial artery to prevent bleeding and permit closure of the wound. Also advantageously, the hemostasis band has features that permit sufficient pressure to be applied to the radial artery (so that the wound can close) while maintaining blood flow through the radial artery or, for that matter, through the ulnar artery or venous return. The wrist splint and homeostasis band can also be combined into one unitary device having all the advantageous features described above.