Abstract:
This invention generally relates to the area of medicine in the surgical field. Containers are used in surgery for application tools for applying objects. Containers especially suitable for holding special objects, in particular hemostatic clamps. Hemostatic clamps are used to tie or clamp blood vessels during surgical procedures. Special containers are used to store and advantageously provide hemostatic clamps. These containers completely and clearly hold clamps in each phase without tilting, and enable reliable removal by a surgeon using a surgical instrument. This is achieved with the container according to the invention, which avoids friction between the clamp and the surgical instrument.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to international application PCT/DE2006/001039, filed Jun. 20, 2006 and German application DE 10 2005 045 006 filed on Sep. 21, 2005. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention generally relates to the area of medicine in the surgical field. Containers are used in surgery for application tools for applying objects. Some containers are especially suitable for holding special objects, in particular hemostatic clamps. Hemostatic clamps are also referred to as ligature clamps. Ligature clamps are used to tie or clamp blood vessels during surgical procedures, and kept in containers. These containers usually consist of holders, cassettes or magazines. The invention relates to such a magazine. 
         [0004]    2. Related Art 
         [0005]    Ligature clamps have been used in surgery for many years. They serve two basic functions, specifically tying vessels, nerves or fluid-carrying vessels of the human body, or marking a special surgical site, typically the periphery of a tumor, for example, which can later be seen in an X-ray. The ligature clamps (hereinafter referred to as clamps) are available in three basic sizes-small, medium and large, as well as in two special sizes combination small/medium and impervious to X-rays. Clamps used early on were V-shaped. However, the disadvantage to clamps shaped like this is that they pressed the vessel away from the clamp or cut into the vessel instead of tying it off. This problem was resolved through the use of pre-shaped, horseshoe-shaped clamps that were described in U.S. Pat. Nos. 3,323,216 and 3,363,628 and are currently in general use. The horseshoe-shaped clamp consists of two essentially parallel legs, which initially fix the vessel between the ends when closed, thereby holding it between the actual ligature between the ends. 
         [0006]    In a typical magazine for holding and providing clamps in the prior art, a plurality of side-by-side clamps, e.g., ten, are pressed onto a rigid middle beam or pillow block. The outer shape of the pillow block corresponds to the inner shape of the horseshoe-shaped clamps. However, the clamps are somewhat smaller than the pillow block, so that the contact pressure between the parallel legs of the clamp and the pillow blocks holds the clamps during transport and prevents the clamps from falling out of the magazine if the magazine is turned or dropped. But this contact pressure is associated with several disadvantages. First of all, the contact pressure makes it hard to grip the clamp via the clamping jaws or branches of an application tool, in particular the special forceps. Secondly, it makes removal a very unsafe process, even though the application tool has two branches that can move relative to each other, the free ends of which each carry longitudinal grooves on the facing sides that run parallel to the branches and are open relative to the opposing branch. Application tools with a narrow clamping jaw width make it more difficult to grip the clamp, especially since the clamp already tightly abuts the pillow block, and therefore cannot be compressed. This significantly increases the friction between the application tool and the clamp, and metal might be shaved off the clamp. If the clamping jaws of the application tool are too wide, the clamp is sometimes not reliably gripped by the clamping jaws after removed from the magazine. As a result, the clamp might slip from the operating position inside the application tool or fall out of the application tool. Another disadvantage is that the contact tension makes it difficult to remove the clamp from the holding device of the magazine. The tight abutment between the clamp and pillow block generates significant friction between the pillow block and clamp, and the relatively small magazine must be held to enable removal. The required handling of the clamp and magazine is associated with additional disadvantages. 
         [0007]    Further developments in prior art are intended to eliminate the above disadvantages. For example, U.S. Pat. No. 4,936,447 discloses a cassette for holding ligature clamps, in which the downwardly open end of the ligature clamps is plugged into a free compartment via a nose saddle, and both sides of its outer contour are held by a respective elastic holding device provided with a notch at the end. The holding device is designed with a special insert, which must additionally be connected with the basic body of the cassette. The notches on the holding device must reliably grip the ligature clamps, but easily release them again during removal by means of an application tool provided for this purpose. In the known cassette, the holding devices must be manufactured to exacting tolerances with respect to dimensions and resilience. They are also only suitable for mounting a single type of ligature clamp. Even if this magazine embodiment makes it possible to eliminate the aforementioned friction disadvantages, there remains the problem that the application tool and retaining straps disrupt each other, since these abut the arms of the clamps, which happen to form the areas into which the forceps reaches. This is the cause of disruptions. Another serious disadvantage to this cassette is that it has no guide for the application tool for removing the ligature clamps. Therefore, disadvantages are associated with handling when gripping the ligature clamps, i.e., the ligature clamp is not optimally situated in the application tool, so that mistakes can be encountered when tying off the vessels. 
         [0008]    In the magazine described in WO 98/05260 A1 and the publications cited therein, each clamp sits astride a fixed element (reverse position with “U” turned upside down) with a complementary shape, which is seamed by a pair of massive transverse walls used to hold the clamps. The clamps incorporated in such a magazine are in part very small, e.g., the dimensions measure on the order of 1.5 mm, making it extremely difficult to handle the clamps. In the known magazines, the clamps are held in such a way that a forceps-like application tool can grasp the clamps when inserted into a magazine, and then pull them out of the magazine. The disadvantage to known magazines here is that the clamps are fixed laterally by elastically resilient clamping elements, which only abut the middle area of the web, and are lifted during the insertion of an application tool. Therefore, the clamps might become tilted or even jammed in the magazine while inserting the application tool, then making it impossible to introduce the clamp into the application tool in the manner envisaged. 
         [0009]    Another problem is encountered in holding devices in clamp magazines according to prior art. In order to ensure that the application tool encompasses the clamps, the clamping jaws of the application tool must be stronger than the clamps. To allow the application tool to reach into the clamp compartment, this compartment must therefore be wider than the clamp. As a result of the wider clamp, the clamp can be varyingly positioned in the compartment as the application tool enters, and not be centered, so that the clamp is not gripped precisely by the middle of the application tool. A clamp not correctly gripped by the clamping jaws of the application tool can cause the clamp to close unevenly. The principle for removing the clamps from a magazine is identical for all known clamp sizes. The magazines for the varying clamp sizes are color-labeled for differentiation purposes. For example, the magazine accompanying the small clamp size is yellow, while it is blue for medium and orange for large. 
         [0010]    There is a need therefore, for an inexpensive container with a simple functional geometry to hold hemostatic clamps, with elevated demands on safe storage and removal, and hence on tying off vessels, exhibiting a structural shape suitable for reliably removing clamps via a surgical instrument. 
       SUMMARY OF THE INVENTION 
       [0011]    In order to create a container exhibiting these features of the invention for holding hemostatic clamps, in particular ligature clamps for surgery, the invention proposes that a container be designed in such a way that the clamps in the container are completely and clearly held without tilting, in particular when introducing a surgical instrument (hereinafter referred to as application tool) into the container. The invention is a container that consists of two components for holding a plurality of storable and retrievable objects, in particular ligature clamps, of which each is formed in a specific mold and can be gripped by an application tool. The two components consist of a lower and upper part. The lower part is fitted with a plurality of clamp compartments, of which each contains at least one lateral wall for bordering the clamping elements and a pillow block for loosely storing the clamp. The upper part is provided with a plurality of clamping elements for holding the clamp in each of the clamp compartments, wherein a clamping element consists of two movable retaining means, which envelope the pillow block in each of the clamp compartments, and of which each retaining means has a contact section that holds the respective clamp on the pillow block. 
         [0012]    The device according to the invention is used in practice as described below. This description is not to be construed as a limitation, but rather serves to describe the general principle underlying the invention. 
         [0013]    In general, this invention has a container consisting of a lower and upper part, wherein the lower part represents the retaining device. The basic part is provided with a plurality of clamp compartments, advantageously with six to ten compartments, each of which can hold a prefabricated ligature clamp. Therefore, each compartment has a pillow block that is dimensioned in such a way as to roughly correspond to the interior dimensions of a ligature clamp, and holds the clamp loosely in the clamp compartment. In order to prevent the clamp from being held by friction, the pillow block has a channel according to the invention. The channel is arranged in the transverse direction to the pillow block and formed on the outer contour of the pillow block, or on the middle line of the pillow block, wherein the middle line of the pillow block is simultaneously the middle line of the clamp compartment. Another advantage to the channel is that the clamp can be centered when fitting the basic part onto the pillow block. This is also necessary because the clamp compartment with pillow block contained therein is larger than the ligature clamp. The size of the clamp compartment is determined by the size of the application tool to be used, which has to be larger in order to grasp the ligature clamp. 
         [0014]    Therefore, the application tool determines the size of the clamp compartment, and the channel determines the location of the clamp on the pillow block, and hence in the clamp compartment. If the basic part of the container is fitted with one clamp per clamp compartment in the clamp compartment, which may also occur automatically as a result of the simple and advantageous construction of the basic part, e.g., with a automatic pick and place machine known from SMD technology, the basic part is fabricated with the retaining device. 
         [0015]    During fabrication, the webs and separating walls arranged on the basic part according to the invention pass through openings situated in the retaining device, wherein the retaining device can be secured to the basic part in various sways, e.g., via bonding or latching on connecting pins projecting at the corners of the upper side of the basic part, wherein the retaining device has the correspondingly necessary holes at the corners. As an alternative, the pins may also be arranged on the lower side of the retaining device, and the holes in the basic part. Other fastening modes or connections between the basic part and retaining device are within the scope of the invention. 
         [0016]    As evident from one embodiment of the container, the clamp centered in the chamber of the pillow block of the basic part is held by a clamping element, wherein the clamping element is formed out of two retaining means per clamp compartment, which envelop the pillow block in the fabricated state. To this end, the retaining means is U-shaped. The clamping element is hence formed out of a pair of retaining means, and holds the clamp between the latter two. As a result, the clamp is clamped from both sides. Clamping takes place via the retaining means in the contact area that are fitted with a latching nose. The latching nose is located at the vertex of the retaining means, and points in the direction of the clamp. In order for the clamp attached in the channel of the pillow block to yield a detachable clamping, the U-shaped retaining means are flexibly arranged on the retaining device. The flexibility stems from the fact that the legs of the retaining means are relatively thin, and secured to the retaining device only at their ends, yielding a certain mobility of the retaining means. Because the U-shaped strap of the retaining means is inclined, the material causes a specific tension (spring force) to be exerted on the clamp inserted in the channel. 
         [0017]    To advantageously remove a clamp from a clamp compartment of a container, the basic part according to the invention is fitted with webs arranged on both longitudinal sides of the basic part on the one hand, and the pillow blocks located in the clamp compartment are provided with a pedestal on the other. The webs are used by the application tool to guide the clamping jaws, while the pedestals are used by the front surfaces of the application tool as a solid stop. 
         [0018]    A clamp is removed with an application tool by inserting the application tool from above between the webs of a clamp compartment on the one hand, and between the two retaining means of a clamping element on the other. The inclined guiding surface on the webs according to the invention leads the application tool against the U-shaped straps of the retaining means, during which the retaining means are forced apart, and the application tool is fixed against the clamp. The application tool reaches its end position once the front surfaces of the two clamping jaws hit the stop of the pedestal, i.e., the insertion depth of the application tool is limited by the stop formed by the pedestal on the pillow block. Once the application tool has been inserted, the clamping jaws of the application tool are optimally situated relative to the clamp. The two legs of the clamps are defined in this position of the application tool in the channels of the two clamping jaws. The leg ends of the clamp are now flush with the ends of the clamping jaws of the application tool. The webs of the U-shaped retaining means according to the invention and the pedestal stop on the pillow bearing ensures a frictionless removal of the clamp from the pillow block, and no friction comes about when introducing the application tool between the chamber and clamping jaws either. 
         [0019]    An exemplary embodiment of the invention is depicted in purely a schematic form in the drawings, and will be described in greater detail below. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a perspective view of a container for holding a plurality of hemostatic clamps, and 
           [0021]      FIG. 2  is a perspective view of the basic part, and 
           [0022]      FIG. 3  is a perspective view of the retaining device, and 
           [0023]      FIG. 4  is a sectional view A-A through the container on  FIG. 1   
       
    
    
     DETAILED DESCRIPTION 
       [0024]      FIG. 1  shows a perspective view of a container  1  for ligament clamps  12 , consisting of a lower base  2  and upper  3  part, wherein the lower base part  2  represents the basic part and the upper part  3  represents the retaining device. The basic part  2  is fitted with a plurality of clamp compartments  4  (see also  FIG. 2 ), of which each has at least one lateral wall  5  for limiting the clamping element  7  and a pillow block  10  for loosely storing the clamps  12 , wherein the pillow block  10  matches the contour  11  of the clamp  12 . In addition, the basic part  2  is provided with a plurality of webs  14 , wherein each clamp compartment  4  accommodates two webs  14 ,  14 ′, and the webs  14 ,  14 ′ are used to guide the application tool  15  (see  FIG. 4 ) for reliably removing the clamp  12 . The webs  14 ,  14 ′ are arranged on the longitudinal sides  16 ,  16 ′ of the basic part  2  at a specific distance X in the longitudinal direction  17  relative to each other, and at a specific distance Y in the transverse direction  18  of the transverse side  19  relative to the pillow block  10 . This arrangement of the webs  14 ,  14 ′ in a longitudinal  17  and transverse  18  direction yields two webs  14 ,  14 ′ per clamp compartment  4 , which are centrally arranged relative to the clamp compartment  4 , and located on the middle line Z of the transverse direction  18  relative to the pillow block  10 . The middle line Z in the area of the pillow block  10  incorporates a channel  13  in its outer contour  11 . The channel  13  is used to center the clamp  12  on the pillow block  10 , and is adjusted to the inner contour  9  of the clamp  12  (not shown). The clamp  12  is loosely accommodated in the channel  13 . The height of the pillow block  10  and height of the lateral wall  5  may correspond to the height of the webs  14 ,  14 ′. The basic part  2  may be one-piece, and can be made out of various materials, preferably out of a plastic that serves medical purposes and resists sterilization. The sectional view A-A through the container  1  is evident from  FIG. 4 . 
         [0025]    As the basic part  2  on  FIG. 2  shows, the pillow block  10  has another function according to the invention. The function involves equipping the pillow block  10  with a pedestal  20 . The pedestal  20  runs in the longitudinal direction  17  of the basic part  2  on either side of the pillow block  10 . The upper side  21  of the pedestal  20  serves as a stop for the front faces  23  of the clamping jaws  22  of the application tool  15  (see  FIG. 4 ). In addition, the surface  24  of the webs  14 ,  14 ′ is inclined on the side facing the pillow block  10 . Therefore, the base surface  25  of the webs  14 ,  14 ′ narrows toward the top end. As a result, the distance of the webs  14 ,  14 ′ in a clamp compartment  4  viewed in the transverse direction  18  is smaller in the base area than in the top area due to the inclined surface  24 . The shortened distance between the two webs  14 ,  14 ′ of a clamp compartment  4  automatically presses the application tool  15  against the retainers  8  in a first step in order to open the latter, and guides it against the clamp  12  in a second step, which is situated between the two retainers  8  to remove them. 
         [0026]    As evident from  FIG. 3 , the retaining device or base cover  3  has openings  30  through which the webs  14 ,  14 ′ of the basic part  2  can extend, and openings  31  that accommodate separating walls  6 . The openings are situated at both longitudinal sides of the retaining device  3  at a certain distance X in the longitudinal direction relative to each other, and at a certain distance Y in the transverse direction similarly to the webs  14 ,  14 ′ in the basic part  2 , wherein the shape of the openings  30  for accommodating the webs  14 ,  14 ′ matches their shape. Other openings  31  in the retaining device  3  are used to accommodate the separating walls  6  of the basic part  2  during fabrication. The openings  31  are located between the adjacent clamping elements  7 , and a separating wall  6  has two lateral walls  5 ,  5 ′, which serve as a lateral stop for the retainers  8 ,  8 ′ (see  FIG. 2 ). In addition, the retaining device  3  is fitted with a plurality of clamping elements  7 , wherein one clamping element  7  is allocated to each clamp compartment  4 . A clamping element  7  here consists of two paired retainers  8 ,  8 ′, with there being one pair per clamp compartment  4 . The retaining means  8 ,  8 ′ are U-shaped, wherein the legs  32  of the U-shaped strap  33  project from the retaining device  3 . The vertex area  34  or contact area of the U-shaped strap  33  has a latching nose  35 , which assumes the function of holding the clamp  12  on the pillow block  10 . The retainers  8 ,  8 ′ are inclined, and meet at the vertex  34 . The distance “U” of the paired retainers  8 ,  8 ′ in the base area  36  of the straps  23  is selected in such a way that the clamping jaws  22  of the application tool  15  can be easily introduced between them. The clamping jaws  22  reach between the retainers  8 ,  8 ′ in a horizontal direction according to the invention, such that no forces act on the container in a tangential direction. The U-shaped strap  33  is biased towards a retaining position. 
         [0027]    In the depicted embodiment the retaining position holds latch  35  over a top surface of the clamp. As the clamping jaws  22  are introduced further, the retaining means  8 ,  8 ′ are bent apart in the vertex area  34 , causing the latching noses  35  to release the clamp  12 . The maximum path that a retaining element  8 ,  8 ′ can traverse from the closed setting to the open setting is limited by the lateral walls  5 ,  5 ′ of the separating wall  6 . This precludes any excess bending of the retaining means  8 ,  8 . If the retainers  8 ,  8 ′ abut the lateral walls  5 ,  5 ′, the clamp  12  is free, and can be removed from the pillow block  10  by the application tool  15  without friction. 
         [0028]      FIG. 4  shows a sectional view A-A of the container  1  fitted with a clamp  12  according to  FIG. 1 , consisting of a basic part  2  and the retaining device  3 , wherein the upper part  3  is advantageously provided with a bordering  38 . The bordering  38  can improve incorporation of the basic part  2  on the one hand, and ease handling by the user on the other. A fastening means  41  (not shown) can be provided on the lower side  39  of the basic part  2  or on the lower side  40  of the bordering  38 . The fastening means  41  consists of a carrier provided on either side with a fixation, which may be double-sided adhesive tape, or alternatively a rigid foam product. As also evident form the sectional view A-A, the clamp compartment  4  is limited in the transverse direction  18  by the webs  14 ,  14 ′ and in the longitudinal direction  17  by a lateral wall  5 . Visible in the middle of the clamp compartment  4  is the pillow block  10  on the pedestal  20 , wherein the pillow block  10  carries a clamp  12 . The clamp  12  is clamped by the latching nose  35  of a retaining means  8 . Schematically depicted on the inclined surface  24  of the webs  14 ,  14 ′ are clamping jaws  22  of an application tool  15  that have not yet reached the end position for removing the clamp  12 . At the end position, the front faces  23  of the clamping jaws  22  would be on the top side  21  of the pedestal  20 , and the clamp  12  would be accommodated by the channels in the clamping jaws  22 , so that the loose clamp can be removed without friction. 
       REFERENCE LIST 
       [0000]    
       
           1  Container  25  Base surface 
           2  Lower part (base)  26  Top surface 
           3  Upper part (device)  27  Free 
           4  Clamp compartment  28  Free 
           5  Lateral wall  29  Free 
           5 ′ Lateral wall  30  openings (webs) 
           6  Separating wall  31  Openings (lateral wall) 
           7  Clamping element  32  Leg 
           8  Retaining means  33  Strap 
           8 ′ Retaining means  34  Vertex 
           9  Inner contour  35  Latching nose 
         ′ 10  Pillow block  36  Base area 
           11  Contour  37  Free 
           12  Clamp  38  Bordering 
           13  Channel  39  Lower side (for  2 ) 
           14  Web  40  Lower side (for  3 ) 
           14 ′ Web  41  Fastening means 
           15  Application tool 
           16  Longitudinal side 
           16 ′ Longitudinal side 
           17  Longitudinal direction 
           18  Transverse direction 
           19  Transverse side 
           20  Pedestal 
           21  Upper side 
           22  Clamping jaw 
           23  Front face 
           24  Inclined surface′