Patent Document

FIELD OF THE INVENTION  
       [0001]     The present invention relates generally to surgical devices for temporarily occluding a blood vessel during an operation, and, more particularly, to a surgical clip that has added convenience and versatility in its use in temporarily occluding a blood vessel.  
       BACKGROUND OF THE INVENTION  
       [0002]     Surgical clips are used in a relatively wide variety of medical operations, particularly surgical procedures undertaken by vascular surgeons in the treatment of cardiovascular disease and some of those procedures include carotid endarectomies and femoral poplitealbypass surgeries. In those, and other such surgical procedures, it is necessary for the vascular surgeon to temporarily occlude certain target blood vessels, thereby stopping the blood flow through such vessels so that the vessels can, for example, be cleared of plaque or other blockages that could prevent proper blood flow in the patient.  
         [0003]     Thus, to carry out that temporary occlusion of such blood vessel, a variety of devices are utilized by the surgeon and, among those devices are vessel clamps or clips which, when used with or without sutures, are effective in temporarily stopping or limiting blood flow for a period of time necessary for the surgeon to carry out and complete other aspects of the surgical technique.  
         [0004]     One typical type of surgical clip includes a coiled spring at the proximal end and having two longitudinally extending members leading outwardly from the spring to distal ends. The spring biases the distal ends toward each other such that the distal ends are normally in a closed position where they abut against each other. The user can move the members against the bias of the spring so as to open the distal ends and move them away from each other. With this type of clip, the distal ends are positioned by the surgeon so as to surround the blood vessel to be occluded while the distal ends are in the open position and the surgeon can simply release the members that enables the spring to move the distal ends to the closed position where they are again adjacent to each other pinching the blood vessel therebetween. As such, that type of surgical clip is a relatively simple yet effective device for occluding a blood vessel.  
         [0005]     There are, however, a number of drawbacks with that type of surgical clip. First of all the present designs are constructed of straight members from the proximal or spring end to the distal end and, therefore, they lack versatility in the ability to be introduced into the patient and reach the particular blood vessel that is desired be occluded, particularly where the blood vessel is not readily accessible and there are other instruments being used on patient that make the use of a straight surgical clip difficult to use. Next, the spring bias is relatively constant among the differing surgical clips and there are times when it would be advantageous to have available to the surgeon, a surgical clip with differing bias. As a further drawback, the present surgical clips are not suitable for occluding more than one blood vessel at a time and, again, there are times where it would be advantageous to have a surgical clip that was capable of occluding at least two blood vessels simultaneously with the same clip.  
         [0006]     As a further difficulty with the clips, themselves, they are normally provided to the surgeon in a relatively unorganized manner that is, the clips are conventionally simply secured to a crude cardboard holder in sterilized condition but presented in a random form. Since 4-5 surgical clips can be used during a normal surgery, the random nature makes it difficult to select and use the particular clips that are needed in a specific operation and it would be advantageous to have a tray where the clips are organized and arranged for a specific surgery for the convenience of the surgeon to be able to more easily select and use the correct clip.  
         [0007]     Accordingly, there is, therefore, a need for a surgical clip that overcomes the aforedescribed difficulties with present surgical clips and for a system that provides an organized access to surgical clips that customizes the types and quantities of such clips for a particular surgical procedure.  
       SUMMARY OF THE INVENTION  
       [0008]     The present invention relates to a surgical clip for use in temporarily occluding one or more blood vessels during a surgical procedure and to a system of providing such surgical clips in a convenient, organized fashion that is customized for a particular procedure.  
         [0009]     In one embodiment of the present invention, the surgical clip comprises a pair of longitudinally extending members that have distal and proximal ends. At or proximate to the distal ends of both of the longitudinal extending members, there is formed a clamping surface region and each of the longitudinal extending member also has a first region where there is a biasing element that biases the clamping surface regions of the longitudinally extending members together in a closed position where those mating clamping surface regions are in an abutting relationship. The clamping surface region of the longitudinal extending members extend outwardly at a less than orthogonal angle with respect to the first regions in order to enable the surgeon to effectively utilize the surgical clip to occlude blood vessels that are relatively inaccessible.  
         [0010]     As such, with the longitudinal extending members formed with an offset intermediate the first regions to the clamping surface regions, the configuration allows for greater ease of use as access, insertion and application of the surgical clip to the vessels is more efficient. In addition, the offset allows the insertion of the surgical clip to avoid entanglement of sutures if sutures are being used in conjunction with the surgical clip.  
         [0011]     As a further feature of the present invention, the closing pressure, that is, the spring pressure that biases the clamping surface regions of the longitudinal extending members toward their closed position can be variable rather than a constant compression pressure so that the surgeon can utilize a surgical clip that has the closing pressure particularly suited and selected for accommodating the condition of the various vessels to be occluded. The variable pressure feature can be accomplished in a number of ways, such as by altering the spring mechanism that provides the closing bias, modifying the cross-section of the clip geometry to minimize contact stresses at the clamping surface regions where the vessel is clamped, adding a protective sleeve or by manufacturing the surgical clip out of a pliable material such as a polycarbonate plastic. If a protective coating or plastic material is used, the surgical clip would then be a single use device to avoid subjecting the plastic material to multiple sterilization processes.  
         [0012]     An additional feature of the present invention can be with the use of color coding of the individual surgical clips or sets of clips, that is, the surgical clips can be color coded in accordance with one or more of their closing pressure, size, type and use. Thus, a surgical clip having a particular closing pressure can therefore be a common color to readily identify to the surgeon that closing pressure and the same color coding can also be used to identify the size of a particular clip such as having all small clips of the same color so that the surgeon can quickly identify the desired surgical clip. The color coding principle can also be applied to sets of surgical clips where a set, for example, of surgical clips to be used for a carotid endarectomy could all be the same color so that the surgeon could immediately recognize the set of surgical clips intended and customized for that specific procedure.  
         [0013]     A further innovative feature of the present inventive surgical clip is in the design of a dual or multi-vessel surgical clip such that there is a large L-shaped configuration that has the ability of securing a large diameter vessel and, at the same time, also secure one of more additional vessels stemming from the larger blood vessel. The feature of a dual or multi vessel clip provides the benefit of ease in use so as to reduce surgical time and also eliminates a high of clutter and confusion resulting from 5 or 6 clips used at the same surgical site.  
         [0014]     As a still further feature of the present invention, there is a surgical clip system comprising a container that has a plurality of receptacles for receipt of a surgical clip. The system customized the receptacles to include clips of at least one predetermined type and number in accordance in accordance with a particular surgical operation. By use of the system, a tray can be provided to the surgeon that has a certain number and sizes of vascular lips that are specially selected to be used during a specific operation so that the surgeon has the correct surgical clips available for the operation being carried out and the surgeon can readily select the proper surgical clip without the need to search through a number of extraneous surgical clips that may not even be usable in carrying out that operation. As examples, if the operation is a femoral popliteal bypass, there may be at least four clips of a particular size and another four clips of a smaller size. If the operation is an a carotid endarectomy, there may be at least two clips of a particular size And at least two other clips of a smaller size. As can thereof be seen, the tray is customized and has receptacles that receive the particular surgical clips that are used during a specific surgical procedure.  
         [0015]     These and other features and advantages of the present invention will become more readily apparent during the following detailed description taken in conjunction with the drawings herein. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]      FIG. 1  is a side view of a typical prior art surgical clip;  
         [0017]      FIGS. 2A-2F  are side views of various surgical clips constructed in accordance with the present invention;  
         [0018]      FIGS. 3A-3D  are perspective views of various surgical clips generally corresponding to the surgical clips shown in  FIGS. 2A-2D ;  
         [0019]      FIG. 4A, 4B  and  4 C are a top view, a side views and a perspective view of a multi-vessel surgical clip of the present invention;  
         [0020]      FIG. 5  is a schematic view of the multi-vessel surgical clip of  FIGS. 4A-4C  in an operative position;  
         [0021]      FIG. 6  is a top view of a backing supporting a plurality of various surgical clips;  
         [0022]      FIG. 7A and 7B  are top views of containers constructed in accordance with the present invention and retaining certain pre-selected surgical clips.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     Referring now to  FIG. 1 , there is shown a side view of a typical surgical clip  10  that is currently in use in carrying out surgical procedures. As can be seen, the surgical clip  10  has a pair of longitudinally extending members  12 ,  14  each of which has a distal end  16 ,  18  respectively and proximal ends  20 ,  22 . At the proximal ends  20 ,  22  there is a biasing element in the form of a coiled spring  24  that provides a bias tending to draw the distal ends  16 ,  18  toward each other into the closed position as illustrated in  FIG. 1 . At or proximate to the distal ends there is located clamping surface regions  26 ,  28  where the particular blood vessel is actually trapped between the longitudinally extending members  12 ,  14  to occlude that vessel. The coiled spring  24  includes actuating legs  30 ,  32  where the user can push inwardly on the actuating legs  30 ,  32  and separate the clamping surface regions  26 ,  28  against the bias of the coiled spring  24 .  
         [0024]     As such, the surgeon can simply push inwardly on the actuating legs  30 ,  32  to separate the clamping surface regions  26 ,  28  to an open position, locate the blood vessel to be occluded within the spaced apart clamping surface regions  26 ,  28  and then release the pressure on the actuating legs  30 ,  32  to bring the mating clamping surface regions  26 ,  28  together such that the bias of the coiled spring  24  clamps about the blood vessel to occlude that vessel. The surgical clip  10  presently in use is provided to the surgeon in various lengths for use in reaching and occluding a particular blood vessel depending upon its size and location. As can be seen, the configuration of the longitudinally extending members  12 ,  14  is constant or smooth from the distal ends  16 ,  18  to the proximal ends  20 ,  22  although there may be a curvature to longitudinally extending members  12 ,  14  along their length.  
         [0025]     Turning now to FIGS.  2 A-D and FIGS.  3 A-D there is shown, side views and perspective views, respectively, of various surgical clips constructed in accordance with the present invention. Accordingly, taking  FIGS. 2A and 3A  initially, there can be seen a surgical clip  34  that includes a pair of longitudinally extending members  36 ,  38  with both having distal ends  40 ,  42  and proximal ends  44 ,  46 . At the proximal ends  44 ,  46 , there is a coiled spring  48  and a pair of actuating legs  50 ,  52 . While a coiled spring is shown, it is noted that other biasing means can be used to provide the desired bias on the longitudinally extending members  36 ,  38 , including, but not limited to, a coil or leaf spring, materials having inherent flexibility or memories, and the use of elastomers such as a flexible sleeve that encircle the extending members of the clip. At or proximate to the proximal ends  44 ,  46  each of the longitudinally extending members  36 ,  38  has a first region  54 ,  56  extending from the coiled spring  48  that is a generally straight configuration and there are also clamping surface regions  58 ,  60  that extend from the first regions  54 ,  56  and when the vascular vessel is located in occluding the vessel during the use of the surgical clip  34 .  
         [0026]     As can now be seen, the mating clamping surface regions  58 ,  60  extend from the first regions  54 ,  56  at a less than orthogonal offset angle A, that is, less than 90 degrees. In  FIGS. 2A and 3A , that angle is about 30 degrees and the overall length L of the surgical clip  34  is about 0.25 inches to about 1.0 inches. In  FIGS. 2B and 3B , the surgical clip  62  has an angle A of about 45 degrees and the same range of lengths as with the embodiment of  FIGS. 2A and 2B . The actual angle may be any angle smaller than an orthogonal angle and preferably, the angle A may range from about 30 degrees to about 60 degrees, While the clamping surface regions  58 ,  60  are shown having a curvature, they, as well as the other regions of the longitudinally extending members  36 ,  38  may also be straight in configuration and still be within the purpose and intent of the present invention.  
         [0027]     In  FIGS. 2C and 3C , the angle A is again about 30 degrees with the surgical clip  64  having a greater length, that is, within the range of about 1.0 inches to about 2.0 inches and in  FIG. 2D and 3D  the angle A of the surgical clip  66  is about  45  degrees and the length is within the same range as the embodiment of  FIGS. 2C and 3C . Accordingly, as now can be understood, in each of the surgical clips  34 ,  62 ,  64 , and  66  the clamping surface regions  58 ,  60  extend from the first regions  54 ,  56  at angles smaller than orthogonal angles and there are differing lengths that are available to the surgeon in occluding a particular blood vessel. In addition the angles A of the various lips can be between about 10 degrees to 60 degrees, and preferably between about 45 and 60 degrees.  
         [0028]     As such, the surgeon has a selection of surgical clips to use in any particular procedure depending upon the size and location of the blood vessel that is desired to be occluded. As a further option in the selection of a particular surgical clip, taking the surgical clip  34  of  FIGS. 2A and 3A  as an example, the amount of force tending to close the longitudinally extending members  36 ,  38 , that is, the squeezing force or pressure applied against a blood vessel may also be varied.  
         [0029]     To change the amount of force, the coiled spring  48  can be constructed by a number of differing ways. One means would be to alter the coiled spring  48  to make it more robust such as by increasing its size or be making it out of a stiffer material such that the spring bias is increased. As an alternative method, the cross-section of the clip geometry can be modified to minimize contact stresses at the clamping surface regions where the vessel is clamped, that is, the actual point of contact with the vessel can be rounded, sharp edged or some configuration that varies in between. Also a protective sleeve can be added or the surgical clip can be manufactured out of a pliable material such as a polycarbonate plastic. If a protective coating or plastic material is used, the surgical clip would then be a single use device to avoid subjecting the plastic material to multiple sterilization processes. In any event, by providing the surgeon with surgical clips having differing degrees of closing pressure, the surgeon can select the surgical clip depending upon the state or condition of the particular blood vessel that is being occluded. The variable pressure is preferred to be within 70 and 120 psi.  
         [0030]     Turning now to  FIGS. 4A, 4B  and  4 C, there is shown a top view, a side view and a perspective view, respectively, of a multi-vessel surgical clip  68  constructed in accordance with the present invention. As can be seen, the multi-vessel surgical clip  68  is a long L-shaped configuration having a pair of longitudinally extending members  70 ,  72  with distal ends  74 ,  76  and proximal ends  78 ,  80 . As with the other embodiments, at the proximal ends  78 ,  80 , there is a coiled spring  82  and a pair of actuating legs  84 ,  86 . At or proximate to the proximal ends  78 ,  80 , each of the longitudinally extending members  70 ,  72  has a first region  88 ,  90  extending from the coiled spring  82  in a generally straight configuration and there are also clamping surface regions  92 ,  94  that extend from the first regions  88 ,  90  and when certain vascular vessels are located in occluding those vessels during the use of the multi-vessel surgical clip  68 . In this embodiment, the angle B is a relatively sharp angle and may be about 80 degrees approaching an L-shape of a ninety degree angle. The angle B, however, can be any angle ranging from about 10 degrees up to 80 degrees. In addition, the length of the multi-vessel surgical clip  68  can range from about 0.5 inches to about 2.5 inches.  
         [0031]     Turning now to  FIG. 5 , there is shown a schematic view of the multi-vessel surgical clip  68  of  FIGS. 4A-4C  and illustrating the use of the device. As can now be seen, the multi-vessel clip  68  actually can occlude a plurality of blood vessels identified in  FIG. 5  as a major blood vessel  96 , such as the carotid artery, and two smaller blood vessels  98 ,  100  that branch off from the major blood vessel  96 . As such the major blood vessel  96  is occluded by being squeezed within the first regions  88 ,  90  and the smaller blood vessels  98 ,  100  are occluded by being squeezed within the mating clamping surface regions  92 ,  94 . Thus, by the particular length and configuration of the multi-vessel surgical clip  68 , the surgeon can occlude all three vessels and avoid the need for three separate surgical clips as is currently used in such procedure. The particular procedure for which the multi-vessel surgical clip  68  is intended is for the occluding of a carotid artery and, to aid in the clamping pressure and effectiveness, there may be a plastic or rubber sleeve or covering over the multi-vessel surgical clip  68 .  
         [0032]     Turning now to  FIG. 6  there is shown a standard surgical clip set  102  that is conventionally used for various surgical procedures to provide individual surgical clips  104  to the surgeon. In the conventional surgical clip set  102 , there are a plurality of surgical clips  104  of differing sizes in order to provide all of the necessary tools to the surgeon, without regard to the particular surgical procedure and the need for very specific surgical clips for a specific surgical procedure. Therefore, at the present, the surgical clip set  102  is generally a cardboard backing on which the various surgical clips  104  are mounted.  
         [0033]     Turning now to FIGS.,  7 A and  7 B, there is shown surgical clip sets  106 ,  108 , respectively, arranged in accordance with the present invention and where the specific surgical clips are predetermined in accordance with the particular procedure being carried out. The surgical clips are carried by a container, such as a tray  110 , and within which there may be receptacles formed therein by a pliable material such as Styrofoam into which each surgical clip is positioned. Thus, in each tray  110 , there is a predetermined plurality of the surgical clips and, in each case, the quantity and type of surgical clips are pre-selected in accordance with a corresponding particular surgical procedure and the clips can be of the type previously described herein.  
         [0034]     As examples, the surgical clip set  106  as shown in  FIG. 7A  can have at least two surgical clips  112  of a predetermined size and at least three other surgical clips  114  of a smaller size than the predetermined size of the surgical clips  112 . Such a set is particularly suited for a surgical procedure known as a carotid endarectomy and thus, the surgeon has a customized set of a predetermined, selected quantity and type of surgical clips available for the operation and need not select from a large quantity of surgical clips where many may simply not even be suitable for the particular operation, thereby reducing the time for selection and easing the selection process of the surgeon who is already fully occupied with the surgical procedure.  
         [0035]     As another example, with the surgical clip set  108  of  FIG. 7B , there can be at least four surgical clips  116  of a predetermined size and at least four other surgical clips  118  of a smaller size than the predetermined size of the surgical clips  116 . Such a surgical clip set is particularly suited for a surgical procedure known as a femoral popliteal bypass and thus, again, the surgeon has a customized set of a predetermined, selected quantity and type of surgical clips available for the operation.  
         [0036]     It should be noted that the aforesaid examples are merely two of many surgical clip sets that can be provided to the surgeon with a predetermined plurality of surgical clips of differing sizes and quantities that are pre-selected for a particular operation so that the surgeon has a convenient and customized set of surgical clips that are specially predetermined for a specific surgical procedure.  
         [0037]     Thus the surgical clips shown and described in the present specification can by used for a number of procedures and among those procedures are the following: 
        1. carotid endarectomy     2. endarectomy of the upper or lower limb arteries     3. femoral-popliteal bypass     4. aorta-renal bypass     5. aorta-iliac-femoral bypass     6. embolectomy, thrombectomy of the carotid artery or jugular vein     7. embolectomy, thrombectomy of the upper or lower limb vessels     8. resection of the carotid artery or jugular vein with anastomosis     9. resection of the upper or lower limb vessels with anastomosis     10. angiectomy of the carotid artery or jugular vein     11. angiectomy of the upper or lower limb arteries of veins     12. arteriovenostomy for renal dialysis     13. revision or removal of arteriovenous shunt for renal dialysis     14. reimplantation of aberrant renal vessel     15. trauma surgery.        
 
         [0053]     Other procedures, not listed herein may, of course, be carried out with the aid of one of more of the vascular clips described herein.  
         [0054]     An additional feature of the invention can be with the use of color coding of the individual surgical clips or sets of clips, that is, the surgical clips can be color coded in accordance with one or more of their closing pressure, size, type and use. Thus, a surgical clip having a particular closing pressure can therefore be a common color to readily identify to the surgeon that closing pressure and the same color coding can also be used to identify the size of a particular clip such as having all small clips of the same color so that the surgeon can quickly identify the desired surgical clip. The color coding principle can also be applied to sets of surgical clips where a set, for example, of surgical clips to be used for a carotid endarectomy could all be the same color so that the surgeon could immediately recognize the set of surgical clips intended and customized for that specific procedure. It should be readily understood that reference to color coding of a surgical clip is meant to cover including such color on at least a portion of the surgical clip.  
         [0055]     Those skilled in the art will readily recognize numerous adaptations and modifications which can be made to the surgical clips and methods of the present invention which will result in an improved surgical clip and method, yet all of which will fall within the scope and spirit of the present invention as defined in the following claims. Accordingly, the invention is to be limited only by the following claims and their equivalents.

Technology Category: 1