Abstract:
A package is used for the packaging of an anchor element together with a suture thread which is threaded on the latter. It is proposed to provide the package with an outer casing hermetically closed to the outside, the casing container holder which receives said anchor element and which has a seat for the suture thread already wound on the anchor element.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The invention relates to a package for an anchor element and a suture thread, said anchor element being able to be introduced with the suture thread into a bone for the purpose of fixing a tendon.  
         [0002]     Anchor elements of this kind, also called suture thread anchors, are used in the medical field to ensure that tissues, mostly tendons, that have become detached from a bone can be fixed back onto the bone. For this purpose, the anchor element, into which a suture thread is threaded, is driven into the bone. The two suture thread ends are then tied onto the detached tendon and thus fix the latter back on the bone.  
         [0003]     Different designs of anchor elements are known, for example those known from U.S. Pat. No. 4,632,100, U.S. Pat. No. 5,690,676 and U.S. Pat. No. 6,139,565.  
         [0004]     Such an anchor element generally comprises an approximately cylindrical or pin-shaped body whose outer surface is provided with barb-like projections, and, after the anchor element has been driven into the bone, the barbs prevent it from being withdrawn from said bone. These barbs can also be designed as an outer thread, depending on the technique used to insert the anchor element. One technique involves forming a bore in the bone and striking or driving the anchor element into said bore. In another technique, without provision of a bore, the anchor element is turned in the manner of a screw into the bone or spongy substance. Depending on its design, the anchor element can be made of metal material, for example titanium, but designs made of bioabsorbable materials are also known.  
         [0005]     A common feature of all these anchor elements is that they have to be connected to a tool in order to fit them in place, either with a kind of screwdriver or what is called a driver device.  
         [0006]     For this purpose, a recess, for example in the shape of a hexagon, is usually provided at the proximal end of the anchor element, and a correspondingly shaped tool is pushed into the recess in order to fit the anchor element into the bone.  
         [0007]     Since anchor elements of this kind are relatively small (lengths in the range of 1 to 1.5 cm and diameters in the range of 3 to 5 mm are common), this attachment to the tool requires a certain degree of attention and dexterity.  
         [0008]     In addition, the anchor element is engaged onto a suture thread, for which purpose the anchor element has a transverse bore in its body or has suitable suture thread eyelets at the proximal end. Passing a suture thread through such a small body also requires a certain degree of attention and dexterity.  
         [0009]     Since both the anchor element and the suture thread remain in the body after the surgical procedure, these structural elements have to be sterile in order to avoid infections. During the actual operation, the assembly made up of tool, anchor and suture thread is made ready by a surgical assistant in most cases. To do this, as has been mentioned, the tool is pushed into the proximal end of the anchor element. The suture thread, which was either already threaded in place beforehand or has now been threaded on, is guided along the tool to the proximal end and is secured there on radially projecting pins, to ensure that the suture thread does not move around and impede the insertion procedure.  
         [0010]     It is an object of the invention to make this preparatory work easier and also to ensure sterile handling during these maneuvers.  
       SUMMARY OF THE INVENTION  
       [0011]     According to the invention, this object is achieved, with a package for an anchor element and a suture thread, by the fact that the package comprises an outer casing, with a holder which is arranged inside the casing and in which an anchor element is received, and with a seat for the suture thread already threaded on the anchor element.  
         [0012]     This measure has the advantage that an assembly made up of anchor element and suture thread is already in a packaged form, i.e. this assembly of anchor element and suture thread has already been prepared at the time of manufacture. This not only makes handling easier, since the threading-in procedure is dispensed with, it also makes it possible for these two structural elements remaining in the body to be jointly sterilized.  
         [0013]     The fact that the anchor element is received in a holder means that, in the subsequent maneuvering stages, that is to say during production of the package and subsequently upon opening of the package, this element no longer needs to be touched, with the result that it can be kept sterile. The provision of a seat for the suture thread already threaded onto the anchor element affords the possibility of stowing the suture thread which is in fact often relatively long compared to the anchor element. Customary lengths for the two suture thread ends protruding from the anchor element are in the range of 20 to 30 cm, such that, compared to the small anchor element body, the suture thread takes up a relatively large amount of space. The receiving seat now opens up the possibility of arranging or stowing the suture thread there in a defined pattern that saves space.  
         [0014]     This assembly made up of holder, anchor element and suture thread can be produced as a sterile assembly, which is then provided with an outer casing that closes this sterile assembly off from the outside. In this state, the package can now be dispatched from the original manufacturer and kept in stock in hospitals or general practices.  
         [0015]     To prepare for the surgical intervention, the package is taken hold of and the outer casing is opened, after which it is possible to access the sterile components, namely the anchor element and the suture thread already engaged on the latter. The provision of a holder allows that the anchor element and the suture thread do not have to be gripped directly during the subsequent handling, and instead they can be gripped via the holder, with the result that their sterile state can be maintained, while the anchor element is connected to the tool. This opens up the possibility of then removing the suture thread from the seat, fixing it to the tool, and then finally withdrawing this assembly of tool, anchor element and suture thread from the holder and bringing it to the operating site. The tool used for handling can be a reusable tool, which is economic. After use, the tool can be sterilized and used again.  
         [0016]     Handling is not only made easier by this, it can also be done in a sterile state.  
         [0017]     In a further embodiment of the invention, the anchor element is received in a defined position in the holder.  
         [0018]     This measure has the advantage that the person handling it knows exactly which orientation the anchor element is received in the holder, and this greatly facilitates the subsequent maneuvering and handling.  
         [0019]     In a further embodiment, the anchor element is received in the holder in such a way that a tool for handling can be applied to the anchor element.  
         [0020]     This measure has the advantage that not only can the anchor element be held in a defined position, it can also at the same time be given a specific orientation which is such that, even with the anchor element still held in the holder, the tool can be brought up to it and, depending on its design, fitted onto it or pushed into it. Thus, these maneuvers are not only made easier, they can also be carried out while a sterile state is maintained, and without its being necessary to grip the anchor element during these maneuvers.  
         [0021]     In a further embodiment of the invention, the holder is designed as a handle.  
         [0022]     This measure has the considerable advantage that, in order to facilitate the aforementioned maneuvers for attaching the tool to the anchor element, the holder can be gripped in one hand by the person handling it and can be brought into a suitable orientation, while the other hand applies the tool. This combination makes handling much easier and allows these maneuvers to be carried out in a sterile state.  
         [0023]     In a further embodiment of the invention, the holder at the same time carries the suture thread.  
         [0024]     This measure has the advantage that a very compact assembly is obtained, since the holder also serves at the same time as a seat for the suture thread. This assembly made up of holder, suture thread and anchor element can thus be suitably handled without the need for relative displacements between the anchor element and the suture thread. It is only after the tool has been pushed into or fitted onto the anchor element that the suture thread needs to be moved in order to fix it to the tool.  
         [0025]     In a further embodiment of the invention, the anchor element and holder are connected captively to one another, but in a detachable manner.  
         [0026]     This measure has the advantage that the anchor element is held captive in the holder, such that, during the above-described handling, there is no danger of the anchor element accidentally coming loose from the holder, for example falling out of the latter. By means of the possibility of detachment, this connection can be undone after the tool has been applied to the anchor element and pushed into it.  
         [0027]     In a further embodiment of the invention, the holder is designed as a blank.  
         [0028]     This measure has the advantage that such a blank can be produced inexpensively, simply and in many varied formats that can have corresponding features, namely for the holder of the anchor element and the seat for the suture thread. The blank can be cut or punched out from a planar material. The material can be a paper material.  
         [0029]     In a further embodiment of the invention, the blank is folded into an envelope-like body, in the interior of which the suture thread is received.  
         [0030]     This measure has the advantage that the relatively long suture thread in the envelope can be arranged as a more or less ordered bundle or ball. For this purpose, during manufacture of the package, the suture thread can be applied to a surface of the blank, and another section can then be folded round it to form an envelope-like body. To remove the suture thread, this envelope can then easily be opened again and the suture thread can be removed without problem.  
         [0031]     In a further embodiment of the invention, the blank has at least one flap into which the anchor element is inserted.  
         [0032]     This measure has the advantage that the aforementioned defined positioning and exact orientation of the anchor element holder can easily be achieved by simple machining operations. The anchor element can simply be pushed into such a flap and held and also handled there. The blank itself permits handling with one hand, without any need to touch the anchor element fitted in the flap.  
         [0033]     The flap is produced in a particularly simple way by punches being made in the blank.  
         [0034]     Handling is made even easier if the flap has a predetermined break point.  
         [0035]     This measure has the advantage that the flap is torn open in order to remove the anchor element. As was mentioned at the outset, the outer surface of the anchor element is provided with barb-like anchoring elements which permit insertion in one direction, for example into the bone substance, and provide blocking in the opposite direction. By suitable shaping of the flap, it is now possible to first push the anchor element into the flap, while removal is blocked because of this barb-like design. By means of the predetermined break point, the flap can now simply be torn open to permit removal. On the one hand this ensures a particularly secure hold of the anchor element on the holder, while on the other hand also ensures that the anchor element can be removed from the holder without any danger of relative displacements taking place between anchor element and tool during this removal.  
         [0036]     In a further embodiment of the invention, the seat for the suture thread is designed as a wind-on body onto which the suture thread is wound.  
         [0037]     This measure has the advantage that the suture thread is wound as a positionally defined structure around the body, such that there is no possibility of the two ends of the suture thread becoming entangled. The suture thread can accordingly be unwound again from the wind-on body, after the anchor element is fitted onto the tool.  
         [0038]     In a further embodiment of the invention, the holder is designed as a wind-on card, onto which the anchor element can additionally be integrally formed.  
         [0039]     If, for example, the anchor element is made of plastic material, these measures have the advantage that the holder and the anchor element can be produced in a single injection-molding operation. The suture thread can then be applied to or threaded into or wound onto this injection-molded assembly of holder and anchor element. After the tool has been applied and the suture thread unwound, a lateral tilting movement allows the anchor element to be broken off from the wind-on card, for which purpose the anchor element is connected to the wind-on card only via fine material webs, which then constitute predetermined break points.  
         [0040]     In a further embodiment of the invention, the holder is designed as a bobbin body onto whose bobbin the suture thread is wound. In addition, the anchor element can be inserted into the hub opening of the bobbin body.  
         [0041]     These measures have the advantage that, on the one hand, the suture thread is wound on in a very defined manner and can accordingly be easily unwound, and also that, by fitting the anchor element into the central hub opening, a very small, compact assembly and a correspondingly small package is obtained.  
         [0042]     In a further embodiment of the invention, the holder is designed as a tubular body in whose interior the anchor element and the suture thread are received.  
         [0043]     This measure has the advantage of providing a slender body into which the anchor element and the suture thread can be pushed. The tubular body can, for example, have a clear internal diameter approximately corresponding to the external diameter of the anchor element, such that the latter can be introduced into this body and be held by the latter, and so the holder at the same time constitutes a casing. If, for example, the anchor element is pushed into the tubular body such that its proximal end comes to lie at one end of the tubular body, the corresponding opening possibility can be provided there, such that, after opening, the tool can be applied, for which purpose the package in the form of the tubular body can still be held in the hand. The anchor element and suture thread are then withdrawn from the tubular body.  
         [0044]     It will be appreciated that the aforementioned features and the features still to be explained below can be used not only in the cited combinations, but also in other combinations or singly, without departing from the scope of the present invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0045]     The invention is described and explained in more detail below on the basis of a number of illustrative embodiments and with reference to the attached drawings, in which:  
         [0046]      FIG. 1  shows a side view of a first illustrative embodiment of a package according to the invention,  
         [0047]      FIG. 2  shows a partial perspective view of the package from  FIG. 1  after removal of the outer casing during a stage of the handling procedure,  
         [0048]      FIG. 3  shows a side view, comparable to the depiction in  FIG. 4 , of a second illustrative embodiment of a package according to the invention designed as a wind-on card with an anchor element formed integrally thereon,  
         [0049]      FIG. 4  shows a third illustrative embodiment, in partial section, in the form of a bobbin body with inserted anchor element, and  
         [0050]      FIG. 5  shows a side view of a fourth illustrative embodiment of a package according to the invention with a tubular body.  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0051]     In  FIGS. 1 and 2 , a first illustrative embodiment of a package according to the invention is designated in its entirety by reference number  10 .  
         [0052]     The package  10  has an outer casing  12  which is constructed from two superposed rectangular films  14  and  16  to form a pocket, by means of the two films  14 ,  16  being connected to one another by a peripheral adhesive join  18 .  
         [0053]     The rectangular film  16  protrudes slightly beyond the other film  14  on one of the short sides of the rectangle, as a result of which a protruding flap  20  is formed which makes it easier to tear open the outer casing  12 . For this purpose, the adhesive join  18  is designed as an adhesive seal that connects the two films  14  and  16  to form a casing hermetically closed off from the outside, but which allows the two films  14  and  16  to be peeled off from one another in order to open the casing. The films themselves are made from plastic-coated aluminum films.  
         [0054]     Arranged in the interior of the outer casing  12  there is a holder  22  which supports an anchor element  24  and a suture thread  26  connected to the anchor element  24 .  
         [0055]     The holder  22  is produced from a paper blank  28  which is punched and folded in such a way as to form an envelope  30  in the manner of an envelope for letters.  
         [0056]     For this purpose, one side of the blank  28  is provided with a slit  32  into which a tuck-in tab  34  can be inserted, so as to form the aforementioned envelope  30 .  
         [0057]     In the area of the upper fold edge  36  in the view in  FIGS. 1 and 2 , three punch cuts  38 ,  39  and  40  are made so as to form a flap  42 , the paper material being pressed inward on both sides in the form of pockets  44  and  45 . As will be seen in particular from  FIG. 2 , the flap  42  is provided with a predetermined break point  43 , which can also be applied during the punching operation.  
         [0058]     As will be seen in particular from  FIG. 1 , these design measures serve to support the anchor element  24  in a defined position.  
         [0059]     As will be seen in particular from  FIG. 2 , the anchor element  24  has an approximately cylindrical body  48  which merges at the distal end into a point  50 .  
         [0060]     On its outer face, the body  48  is provided with three hooks  52 ,  53  and  54  which are designed in the manner of annular flanges, and these each merge into the body  48  via a bevel oriented in the direction of the point  50 . At the opposite end, the hooks  42  merge into the body  48  via a relatively straight undercut or step. In the area between the hooks  52  and  53 , a transverse opening  56  is provided which extends right through the body  48  and through which a suture thread  26  is threaded, specifically in such a way that suture thread halves of approximately the same length come to lie on both sides of the opening  56 . In the outer surface of the body  48 , starting from the opening  56  and extending as far as the proximal end  60 , notches  58  arranged diametrically opposite one another extend as far as the proximal end  60  and open out there. These notches  58  are used to guide the suture thread within the notches  58  along the body  48  from the opening  56  to the proximal end.  
         [0061]     In the area of the end  60 , the body  48  is provided with a recess  62 , for example of hexagonal cross section.  
         [0062]     This recess  62  is used to receive a correspondingly shaped projection  64  of a tool  66 , in this case a driver device. This means that the projection  64  has a corresponding hexagonal cross section that corresponds to that of the recess  62 .  
         [0063]     The tool  66  is designed as a rod-shaped body  68  with a shaft (not shown here) and a handgrip, and two stubs  70  and  71  protrude radially from the rod-shaped body  68  at an axial distance from the projection  64 , for example at a distance of 10 to 15 cm.  
         [0064]     The two ends of the suture thread are wound around these stubs after the projection  64  has been pushed into the recess  62 .  
         [0065]     In  FIG. 2 , simply for the purpose of explaining the construction of the anchor element  24 , the latter is shown already removed from the holder  22 , in order also to demonstrate, among other things, how the two ends of the suture thread  26  are received in the inside of the blank  28  that has been folded to form an envelope  30 . For explanatory purposes, the figure also shows the projection  64  not yet pushed into the recess  62 .  
         [0066]     It will also be seen from  FIG. 2 , in conjunction with  FIG. 1 , that the distance between the two hooks  53  and  54  corresponds approximately to the width of the flap  42 .  
         [0067]     It will be seen from  FIG. 1  that the anchor element  24  is inserted sideways into the holder  22  in such a way that the flap  42  comes to lie between these two hooks  53  and  54 . Insertion is made easier by the fact that the hooks are beveled in this direction, and withdrawal or accidental falling-out is prevented by the undercut or shoulder at the proximal end of the hooks  53 ,  54 .  
         [0068]     To manufacture the package  10 , the blank is punched out, the suture thread  26  onto which the anchor element  24  is already engaged is placed in the envelope  30 , the latter is then closed by inserting the tuck-in flap  34  into the slit  32 , and the anchor element  24  is pushed into the flap  42 . This assembly can now be sterilized, or these structural parts can be sterilized before being assembled, in which case care must be taken to ensure that the folding and tucking-in take place in a suitably sterile state, for example also in an automated manner.  
         [0069]     The assembly composed of the holder  22 , of the anchor element  24  inserted therein, and of the suture thread  26 , is now pushed into the interior of the outer casing  12  and the adhesive join  18  is produced, for example by heat-bonding or the like. In this packaged state, shown in  FIG. 1 , the package  10  can now be transported and handled.  
         [0070]     During the handling involved in preparing for a surgical intervention, the outer casing  12  is torn open and the holder  22 , that is to say the envelope  30 , is removed from the torn-open envelope. To do so, the person handling it can, for example, grip the envelope  30  via the right-hand outer end thereof.  
         [0071]     By virtue of the fact that the anchor element  24  is in an exactly defined position and has been inserted into the envelope  30  such that its proximal end  60  with recess  62  protrudes from the upper left end, the person handling it can now use his other hand to apply the tool  66  to the recess  62  and push the projection  64  in. By means of a lateral tilting movement, the predetermined break point  43  of the flap  42  can now be broken open, and the assembly made up of tool  66  and anchor element  24  can be withdrawn from the envelope  30 , in which process the suture thread  26  already threaded in the anchor element  24  is also withdrawn. To make this easier, the tuck-in flap  34  can be removed from the slit  32  for example, and in this way the envelope  30  is opened. The two ends of the suture thread  26  are then wound around the stubs  70  and  71 , after which the anchor element  24  is then ready for insertion into the bone.  
         [0072]     In the second illustrative embodiment, shown in  FIG. 3 , the package according to the invention is designated in its entirety by reference number  80 .  
         [0073]     Here too, the package  80 , as described above, has an outer casing  82 , in the interior of which a holder  84  is received.  
         [0074]     The outer casing  82  can be configured like the above-described outer casing  12 .  
         [0075]     The holder  84  is designed as a wind-on card  86  in the form of a plate-shaped plastic injection-molded body onto which the anchor element  88  is likewise molded as an injection-molded plastic part during the initial manufacturing process. For this purpose, the point of the anchor element  88  is securely connected to the wind-on card  86  by a web  90 . In order to save space, a notch  92  is provided in which part of the body of the anchor element  88  comes to lie.  
         [0076]     In the wind-on card  86 , on both sides of a lengthwise edge, a notch-like narrowed area  94  is provided around which the suture thread  96  is wound, and the latter is fixed in position by means of its end being connected to the wind-on card  86  via a knot  98 .  
         [0077]     In the manufacturing process, as has already been described, the wind-on card, with the anchor element formed integrally thereon, is first produced in an injection-molding operation. The suture thread  96  is then threaded through the anchor element  88  and, as described above, wound up and fixed. This assembly is also sterilized and is then inserted into the outer casing  82 , and the latter is closed.  
         [0078]     During the handling procedure, the outer casing  82  of the package  80  is again torn open, and the wind-on card  86  can be gripped by hand at a free end area and, as has been described above, the tool  66  can be pushed into or fitted on the anchor element  88 . For this purpose, this proximal end of the anchor element  88  protrudes slightly from the wind-on card  86 , in order to make this procedure easier. The suture thread  96  is now unwound and connected to the above-described stubs  70  and  71  of the tool  66 . By means of lateral tilting away from the plane of the wind-on card, the web  90  is broken, such that the anchor element  88  along with the suture thread  96  can then be removed.  
         [0079]      FIG. 4  shows a third illustrative embodiment of a package  100  according to the invention. Here too, the package  100  has an outer casing  102  in the interior of which a holder in the form of a bobbin body  104  is received. The suture thread  108  is again wound onto the actual bobbin  106  of the bobbin body  104 . The anchor element  110 , which is connected to the suture thread  108 , is fitted into the hub opening  112  of the bobbin body  104 . A particularly compact assembly is created here. The anchor element  110  is again fitted in such a way that the tool  66  can easily be pushed into its recess at the proximal end. In doing so, the holder in the form of the bobbin body is held by one hand. The suture thread is then unreeled and again connected to the stubs  70  and  71 , after which the assembly is withdrawn from the bobbin body  104  and the latter is discarded.  
         [0080]      FIG. 5  shows a fourth illustrative embodiment of a package  120  according to the invention.  
         [0081]     The package  120  has a tubular body  122  which is closed at one end by a cap  124 .  
         [0082]     An anchor element  126 , with a suture thread  128  engaged in the latter, is introduced into the tubular body. The clear internal diameter of the tubular body  122  corresponds to the external diameter of the anchor element  126 , such that the latter can be introduced into the tubular body  122  and be safely guided and held therein. The package  120  can also be provided with an additional outer tear-open casing. However, the cap  124  can also be fitted directly onto it, such that the tubular body  122 , with the cap  124  fitted thereon, then constitutes the outer casing.  
         [0083]     During use, the cap  124  is removed and the assembly made up of suture thread  128  and anchor element is gradually withdrawn. Before the anchor element  126  is withdrawn completely from the tubular body  122 , the tool can be pushed into the proximal end. For this purpose, given a suitably flexible design of the tubular body  122 , the anchor element  126  can be briefly held in place by lateral pressing, and this procedure can also be done in a sterile state.  
         [0084]     It is also possible for the anchor element shown at the lower end in  FIG. 5  to be inserted in the reverse orientation and to provide a predetermined break point or corresponding cap at the lower end. Once again, after the cap has been removed, the tool can then first be fitted in place, and the assembly made up of anchor element  126  and suture thread  128  can then in this case, in the view in  FIG. 5 , be pulled downward out of the tubular body  122 .