Abstract:
A biocompatible surgical fastener, comprising a sleeve and a screw or a pin, which expands when it is implanted in a patient. The sleeve is first implanted in a pre-drilled hole in the operating area of a patient, usually in a bone, cartilage or a bone and cartilage. When a screw or a pin is installed in the sleeve, the sleeve is caused to expand thereby stabilizing the fastener in the operating area. In many embodiments the screw or pin can be removed and reinserted without disturbing the tissue in the operating area. The surgical fastener can be used to repair tissue or to secure other implant devices in a patient.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention has to do with surgical fasteners which are implanted in the body. In particular, the invention has to do with improved surgical fasteners which expand when they are implanted in a patient. The expansion stabilizes the fastener in the patient. 
     2. The Related Art 
     Expansion fasteners such as the Molly® expansion bolt sold by The Black &amp; Decker Corporation are known in the fastener art. Applicants have now discovered that fastener products employing similar principles can be modified in new ways for use as surgical implants. 
     Bone, except in the skull, has an outside cortical shell which is hard and strong with an average thickness from about 0.05-0.4 millimeters (“mm”). The portion of the bone under the cortical shell is cancellous and is a much softer material. This characteristic of bone structure creates problems in surgery. Conventional surgical screws, for example, can loosen and become unstable, for example, they may rotate over time and pull out requiring re-surgery. They can also break or become infected and have to be removed. They may be overtightened causing the bone to be stripped out or the patient may have weak bone tissue or bones weakened by disease such as osteoporosis so that the bones are not strong enough to hold the screw. These problems and many others are solved by the fasteners of the present invention. 
     SUMMARY OF THE INVENTION 
     The invention has to do with surgical fasteners which expand when they are implanted in a patient. Each fastener is comprised of a sleeve in combination with a screw or a pin. The sleeve is designed to receive the screw or pin. And when the screw or pin is inserted into the sleeve, at least a portion of the sleeve expands. During surgery, the sleeve, with or without a partially inserted screw or pin, is first implanted in a pre-drilled hole in the operating area, usually a bone and sometimes also the cartilage, of the patient. Then the screw or pin is sufficiently inserted into the sleeve to cause the sleeve to expand. The expansion stabilizes the fastener in the patient. In many embodiments, the screw or pin can be removed and reinserted without disturbing the bone tissue. 
     The surgical applications for use of the fasteners of the invention are numerous. They are useful in any application where a surgeon might need a means to repair a bone, attach cartilage or a tendon to a bone, anchor another medical implant device, and the like. For example, the fasteners can be inserted through the top tibial trays, can be used to hold down trauma plates, artificial joints, other plates and mesh materials, acetabulum cups, external halos and the like. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings are intended to be illustrative, are not drawn to scale and are not intended to limit the scope of the claims to the embodiments depicted. 
       FIGS. I-A and I-B are elevation views of a screw/threaded-type fastener of the invention before the screw is inserted in the threaded sleeve. 
       FIG. I-C is a top view of FIG. I-B. 
       FIG. I-D is a section view of FIG. I-B taken along section line A-A. 
       FIG. II is an elevation view of a screw/threaded-type fastener of the invention after the screw is inserted into the sleeve. 
       FIG. III illustrates an elevation of a fastener of the invention implanted in a bone wherein the bone is illustrated partially and in section. 
       FIG. IV-A is an elevation view of another embodiment of a threaded sleeve of the invention. 
       FIG. IV-B is a top view of FIG. IV-A. 
       FIG. IV-C is a section view of FIG. IV-B taken along section line A-A. 
       FIG. IV-D is a section view of FIG. IV-B taken along section line B-B. 
       FIG. IV-E is an alternative embodiment of the sleeve of FIG. IV-A having a pointed distal end. 
       FIG. IV-F is a further alternative embodiment of the sleeve of FIG. IV-A having a bull nose distal end. 
       FIG. V-A is an elevation view of another embodiment of a threaded sleeve of the invention. 
       FIG. V-B is a top view of FIG. V-A. 
       FIG. V-C is a section view of FIG. V-A taken along section line B-B. 
       FIG. VI-A is an elevation of a wing-type sleeve of the invention. 
       FIG. VI-B is a top view of FIG. VI-A. 
       FIG. VI-C is a section view of FIG. VI-A taken along section line A-A. 
       FIG. VI-D is a section view of FIG. VI-B taken along section line B-B. 
       FIG. VI-E is an alternative embodiment of the sleeve of FIG. VI-A having sequentially activated wings. 
       FIG. VII-A is an elevation view of another embodiment of a wing-type sleeve of the invention. 
       FIG. VII-B is a top view of FIG. VII-A. 
       FIG. VII-C is a section view of FIG. VII-A taken along section line A-A. 
       FIG. VII-D is a section view of FIG. VII-B taken along section line B-B. 
       FIG. VIII-A is an elevation view of still another embodiment of a wing-type sleeve of the invention. 
       FIG. VIII-B is an elevation view of the sleeve of FIG. VIII-A which has been rotated 90° about the y-y axis. 
       FIG. IX-A is an elevation view of a pin/wing-type fastener of the invention wherein the sleeve has the same design as the sleeve of FIG. VII except for the added annular recess  81  shown in FIG. IX-B wherein FIG. IX-B is a section view of FIG. IX-A taken along section line A-A. 
       FIGS. IX-C and IX-D are section views of the sleeve of FIG. IX-A implanted in a bone with a pin set in the sleeve. 
       FIG. X is a perspective view of a sleeve of the invention installed in a plate, tibial tray or the like. 
       FIG. XI-A is an elevation view of a sleeve of the invention which is used as a plug. 
       FIG. XI-B is a top view of FIG. XI-A and FIG. XI-C is a section view taken along section line A-A. 
       FIGS. XII-A-J illustrate top views of some of the various head configurations for the screws and pins of the invention and some configurations for the flanges. 
       FIGS. XIII-A and B illustrate in elevation some additional pin and screw embodiments for use with the sleeves of the invention. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The fasteners of the invention can be made of various biocompatible materials and combinations of biocompatible materials. For example, the sleeve and the corresponding screw or pin of a particular fastener can be made from the same materials or different materials. As another example, the sleeve can be made of different materials so that one portion will be absorbed by the body more quickly than another or one portion will be absorbed and the other will not. Other variations and combinations of materials will be apparent to those having skill in the art. Suitable materials include tissue friendly metals, alloys, synthetic metals, plastics and reinforced plastics which are commonly used in surgical implants of all kinds. Such materials include materials that have sufficient strength to meet the objectives of the invention and that have been approved by the United States Food and Drug Administration (FDA) for surgical implant applications. 
     Generally speaking, there are three main types of alloys used in orthopedic metals today, titanium alloys, cobalt alloys and stainless steel alloys. An exhaustive list is available on the FDA website which also provides the reference numbers and effective dates of the ASTM or ISO standards for the materials. Some examples include unalloyed and alloyed titanium; molybdenum, chromium, cobalt, tungsten, aluminum, niobium, manganese or vanadium in various combinations as alloys or components of alloys, various stainless steels and other iron alloys; aluminum oxides, zirconium oxides, tantalum and calcium phosphates. 
     Numerous types of high strength polymers also are employed to make implants and many of these are identified not only on the FDA website mentioned above but also on the ASTM website. Examples of suitable high strength polymers include polyetheretherketone (PEEK), epoxys, polyurethanes, polyesters, polyethylenes, vinyl chlorides, polysulfones, polytetrafluoro-ethylene (PTFE), polycarbonates, polyaryletherketone (PAEK), polyoxymethylene, nylon, carbon fiber polyester, polyetherketoneetherketoneketone (PEKEKK), silicones and the like. When a polymer is used, a small wire or other material can be incorporated in the main body of the base for purposes of x-ray detection. 
     The foregoing lists of materials may have application in some embodiments of the present invention but not in others as will be apparent to those skilled in the art based on requirements of strength, flexibility, machinability and the like for the particular application. The lists are intended to be illustrative and not exhaustive. Other materials and new materials may be employed based upon the principles of the invention as set forth herein. 
     For purposes of this specification, the term “high strength polymer(s)” is defined as any tissue-friendly non-bioabsorbable polymer, copolymer, polymer mixture, plastic or polymer alloy having sufficient strength to withstand without failure the torques and stresses that a fastener of the invention would normally be subjected to during surgery or in the body. 
     Bioabsorbable material can also be used to make all or a portion of one or more of the component parts of the fasteners of the invention and/or the bioabsorbable material can be applied as a partial or complete coating on such component parts. 
     The term “bioabsorbable material” as used herein includes materials which are partially or completely bioabsorbable in the body. 
     Suitable bioabsorbable materials include polyglycolide, poly(lactic acid), copolymers of lactic acid and glycolic acid, poly-L-lactide, poly-L-lactate; crystalline plastics such as those disclosed in U.S. Pat. No. 6,632,503 which is incorporated herein by reference; bioabsorbable polymers, copolymers or polymer alloys that are self-reinforced and contain ceramic particles or reinforcement fibers such as those described in U.S. Pat. No. 6,406,498 which is incorporated herein by reference; bioresorbable polymers and blends thereof such as described in U.S. Pat. No. 6,583,232 which is incorporated herein by reference; copolymers of polyethylene glycol and polybutylene terephthalate; and the like. The foregoing list is not intended to be exhaustive. Other bioabsorbable materials can be used based upon the principles of the invention as set forth herein. 
     Bioactive materials can be admixed with the bioabsorbable materials, impregnated in the bioabsorbable materials and/or coated on the outer surface thereof and/or coated on the base or otherwise provided at the interface of the base with the bioabsorbable material. These materials can include, for example, bioactive ceramic particles, bone chips, polymer chips, capsules or reinforcement fibers and they can contain, for example, antimicrobial fatty acids and related coating materials such as those described in Published U.S. Patent Application No. 2004/0153125 A1; antibiotics and antibacterial compositions; immunostimulating agents; tissue or bone growth enhancers and other active ingredients and pharmaceutical materials known in the art. 
     The products of the invention can be made by molding, heat shrinking or coating the bioabsorbable material on a base which has been provided with attachment means such as those described in our pending patent application Ser. No. 11/025,213 filed Dec. 29, 2004 which is incorporated herein by reference. Many of the screws, pins and other devices described in our pending patent application Ser. No. 11/025,213 filed Dec. 29, 2004 can also be used in or in combination with the fasteners and/or sleeves of the present invention. When the bioabsorbable material will have functional mechanical properties which are not made from the base material, the bioabsorbable material can be molded onto the base in the desired shape. Alternatively, the bioabsorbable material also can be coated, shrink wrapped or molded onto the base. If necessary, the bioabsorbable material can be machined to the desired shape and/or dimensions. 
     The fasteners of the invention are implanted in pre-drilled holes in the operating area of a patient. The operating area is usually in bone but it can be in cartilage and bone when a means (e.g., a washer, plate, bracket, wire or equivalent) is used to hold the cartilage down. The pre-drilled hole is sized to accommodate the sleeve so that the fastener will ultimately be implanted in the manner deemed most desirable by the surgeon. It will be understood that sizing the hole means the shape of the hole and any countersinking that may be desired are drilled in a manner that will cause the implanted fastener to be securely affixed in the patient during surgery. In most cases the sleeve will be implanted first. Threaded sleeves are implanted by screwing the sleeve into the pre-drilled hole with a wrench, screwdriver or other driver. Wing-type sleeves are installed by pushing, tapping, impacting or injecting them into place. A pin or screw is then installed in each sleeve at the appropriate time during surgery. In some surgical applications, it may be desirable to have a screw or pin partially inserted into the sleeve before the sleeve is implanted in the patient. 
     As will be apparent to those skilled in the art, the sizes of the fasteners of the invention can be varied over a broad range to meet their intended applications. The shapes, particularly the outer shapes of the sleeves, can take various forms and the size, lengths, widths and number of the blades, diameters and shapes of the flange, the geometry of the longitudinal slits, etc. can be varied for particular applications within the principles of the invention set forth herein. For example, the lengths of the blades can vary, even on the same sleeve. The flange can be molded or machined together with or separately from the blades. When the flange is made separately, it can be, for example, attached to the blades by heat shrinking, adhesive, tight fit, snap fit or other means known in the mechanical and fastener arts. In some cases it may be desirable for the flange to be made from a different material than the blades, for example, in applications where the flange may need to last longer than the blades or to provide a seat for a screw or pin. 
     Referring to FIGS. I-A, I-B, I-C, I-D and II, FIG. I-A illustrates in elevation a screw/threaded-type fastener  1  of the invention before the screw  3  is inserted into the sleeve  2 . FIG. I-B is an elevation of the sleeve  2  which has been rotated about axis y-y by 90° from FIG. I-A. FIG. I-C is a top view of FIG. I-B and FIG. I-D is a section view of FIG. I-B taken along section line A-A. FIG. II illustrates the fastener  1  shown in FIG. I-A after the screw  3  has been inserted into sleeve  2 . 
     The sleeve  2  is in the shape of a frustum having a proximal end and a distal end and is comprised of a flange  4  at the proximal end. The flange serves to provide a stop for the sleeve to allow it to rest on the cortical surface of the bone or to hold down a plate or other implant device. Various features can be designed into the flange or on the circumference of the flange for driving it into the operating area. This can include hexes, squares, slots, Phillips, spanner holes and the like, either internal or external, sized to mate with appropriate tools for implanting the sleeve into a pre-drilled hole in the operating area. 
     A foot or web  5  is located at the distal end. The foot or web is an optional feature of the invention and it is useful in applications where increased strength of the sleeve may be necessary during installation of the sleeve and prior to installation of the screw or pin. The foot can be comprised of a thin strip of material at the distal end and can be made of the same or different material as the sleeve. Alternatively, a web of the same or different material as the sleeve can be affixed at the distal end. The foot or web holds together the tips of the blades at the distal end of the sleeve and helps to maintain the integrity of the sleeve and avoid premature breakage when it is implanted. 
     Threads  6  and anti-rotation wedges  7  are disposed on the outer surface of the frustum, and the frustum generally comprises two blade sections  8 . The proximal end has a larger diameter than the distal end. 
     The screw  3  is comprised of a shank having threads  9  disposed thereon and a head  10 . 
     The longitudinal slit  14  of sleeve  2  extends into an internal tapered bore  12  (see FIG. I-D). The bore becomes narrower as it approaches the distal end and the threads  9 , which have diameter larger than the diameter of the bore at the distal end, exert increasing pressure on the sides of the bore  12  as the screw is inserted further into the sleeve through opening  19 . The bore as illustrated in FIG. I-A extends through the flange  4  at opening  19  and terminates at the foot or web  5 . Two longitudinal slits  14  extend from the outer surface of the frustum to the bore  12 , essentially bisecting most of the outer surface of the frustum and thereby forming the blade sections  8 . A hexagonal slot  15  is provided so that a hexagonal wrench can be used to screw the sleeve into a bone. It is understood that numerous different kinds of slots, holes or slits can be incorporated into the flange or the outer rim of the flange itself can be shaped (e.g., hexagonally) so that various types of wrenches, screwdrivers and other types of drivers can be used as tools to implant the sleeve into a pre-drilled hole in the operating area of the patient. It is also understood that the sleeve can have more than two blades and, in fact, can have several blades as may be appropriate or necessary for particular applications. The blades can be straight or tapered and can be of various shapes and sizes, even on the same sleeve. 
     Threads  16  mate with the threads  9  of screw  3 . In alternative embodiments, self-tapping screws can be used, particularly when the sleeve is made from a softer material than the screw. When self-tapping screws are used it is not necessary to have threads such as threads  16  in the sleeve. It should be noted that any sleeve of the invention can be designed to work with a screw or a pin to make fasteners for particular applications as will be apparent to those skilled in the art. The opening in the flange which receives the screw or pin accordingly can be straight or tapered or threaded or a combination of any or all. As described above, the sleeve can be supplied with a mated screw, a self-tapping screw, a pin, a rod or any other device which can be affixed in the sleeve. 
     When screw  3  is inserted into sleeve  2 , the foot or web  5  is caused to break, as illustrated in FIG. II, by the pressure exerted by the screw on the sides of the bore  12 . The broken foot or web  5  leaves a gap  11  and the blade sections  8  are caused to move laterally in the directions x-x, thereby expanding the sleeve. Of course, threads  6  are also caused to move in the same lateral directions. This expansion or lateral movement secures and stabilizes the sleeve in the bone and allows the bone to grow into the space occupied by the fastener as the healing process progresses. 
     FIG. III illustrates a screw/threaded-type fastener of the invention implanted in a bone  20 . The bone  20  is a portion of a bone and is illustrated in section whereas the fastener is illustrated in elevation. The bone  20  is comprised of a cortical portion  21  and a cancellous portion  22 . The head  10  of the screw is provided with a transverse bore  13  which extends across the diameter of the head. The transverse bore  13  can accommodate sutures and the fastener accordingly can be used as a suture anchor or a bone anchor. 
     As we have described in the foregoing discussion of FIG. II, the blades  8  and threads  6  have been moved laterally due to pressure exerted by the screw. This lateral movement into the cancellous portion  22  accordingly exerts pressure on the bone thereby securing the fastener firmly in place and preventing rotation or other undesired movement of the sleeve during the installation therein of a screw or a pin and following the installation of the screw or pin. A typical example of an application for the fastener of FIG. III would be to replace a conventional suture anchor that was over-tightened, causing the hole in the bone to be stripped out. The replacement suture anchor could be implanted at the same location as the stripped out hole in the bone, the hole being accommodated to fit the replacement, and a second hole would not have to be drilled at another location on the bone. 
     Referring to FIGS. IV-A, B, C and D, FIG. IV-A illustrates in elevation a threaded sleeve  32  in the shape of a frustum having a proximal end and a distal end. Flange  34  is affixed at the proximal end and a foot or web  35  at the distal end. Threads  36  are disposed on the outer surface of the frustum. The anti-rotation wedges  37  are somewhat curved or angled generally in the direction of the threads and generally extend downwardly from the flange along the outer surface of the frustum. The anti-rotation wedges can be straight, angled or curved as a matter of design choice that will be apparent to those skilled in the art based upon the disclosures herein. The frustum has blade sections  38 . Longitudinal slits  33  extend into internal tapered bore  39 . In the top view, FIG. IV-B, slots  31  are provided for a cruiform screwdriver which is used to insert the sleeve into a pre-drilled hole in the patient&#39;s bone. Referring to FIGS. IV-C and D, a tapered recess  30  is provided in the flange  34  so that a screw or pin with a tapered head can be seated in a position flush with the top surface of the flange. The internal tapered bore  39  is illustrated in FIG. IV-D and the bore is sized so that the diameter d near the distal end is less than the diameter of the screw or pin which is inserted into the proximal end of the sleeve through opening  29 . Accordingly, when the screw or pin is inserted, the foot or web  35  is caused to break and the blades  38  are pushed laterally outward thereby affixing the sleeve more securely in the bone. 
     FIG. IV-E illustrates an alternative embodiment of the sleeve of FIG. IV-A having a pointed distal end  23  and a slit  24 . The slit permits the blades to move apart laterally when a screw or pin is installed in the sleeve. FIG. IV-F illustrates still another embodiment with a bull nose distal end  25  and a slit  26 . The pointed distal end and the bull nose distal end, each with a slit as illustrated (and the slit can be a very thin slit such as a hairline slit) can be provided as an element of the design of any of the various sleeves of the invention. Either design is particularly useful in applications where possible breakage of the bone may be caused by installation of the sleeve. 
     Turning to FIGS. V-A, B and C, FIG. V-A illustrates in elevation a threaded sleeve  2  having threads  46  positioned near the flange  44  so that they primarily engage the outside cortical shell of the bone. The flange  44  is also tapered so that its upper surface can be flush with the surface of the bone or a plate when it mates with a pre-drilled countersink at the outer edge of the pre-drilled hole in the bone or plate. In most cases countersinks are made in plates rather than in bone but in some operations, for example in the knee, a countersink in the bone may be desirable. The sleeve has three blades  48  and an internal tapered bore  49 . The longitudinal slits  43  extend all the way to a web  45  at the distal end. After the sleeve is installed, a screw or pin is inserted into opening  28  and tapered portion  40  allows the screw or pin to be installed so that the top surface of the screw or pin is flush with the top surface of the sleeve and the bone. 
     FIGS. VI-A, B, C and D illustrate a wing-type sleeve  52  having wings  56  longitudinally disposed thereon. An elevation of sleeve  52  is illustrated in FIG. VI-A with a flange  54  at the proximal end and a foot or web  55  at the distal end. When a pin or screw is inserted into opening  27 , it causes the wings  56  to be actuated (i.e., pushed outwardly in a generally lateral direction). If desired, the screw or pin can be sized so that it does not reach the foot or web  55  when fully inserted into the sleeve, in which case the foot or web will not break but will remain closed. Alternatively, a longer screw or pin can be used which will break the foot or web  55  when fully inserted thereby also causing blades  58  to be actuated (i.e., pushed outwardly in a generally lateral direction). 
     FIG. VI-E is an alternative embodiment of sleeve  52 , illustrated in the same section view as shown in FIG. VI-C. In this embodiment, when a screw or pin is inserted into opening  27 , wing  56   a  is actuated before wing  56  is actuated because the screw or pin will reach wing  56   a  before it reaches wing  56 . This sequential actuation is particularly useful to prevent rotation of the sleeve when a screw is inserted into opening  27  and when a lot of pressure is being exerted on the screw which could otherwise cause rotation of the sleeve. Only two wings are illustrated in this embodiment but more than two could be used with each wing being sequentially actuated or with pairs or groups of wings being simultaneously actuated followed by individual or multiple other wings being sequentially or simultaneously actuated. Another example of sequential actuation is described in the foregoing paragraph discussing FIGS. VI-A, B, C and D wherein the wings  56  are actuated followed by actuation of blades  58 . 
     Another embodiment of a wing-type sleeve  62  is illustrated in FIGS. VII-A, B, C and D. FIG. VII-A illustrates the sleeve in an elevation view and FIG. VII-B is a top view of FIG. VII-A. FIG. VII-C is a section view taken along section line A-A and FIG. VII-D is a section view taken along section line B-B. The sleeve has three blades  68  each having a wing  66  affixed and longitudinally disposed thereon. Longitudinal slits  63  open to an internal tapered bore  69 . The bore extends through the flange  64  at opening  26  and a tapered portion  60  allows a screw or pin to be installed so that the top surface of the screw or pin is flush with the top surface of the sleeve. The top surface of the sleeve can also be made flush with the top surface of a bone or plate or other implant device in which it is installed by preparing the bone or plate or other implant device with a countersink which is sized to accommodate the flange  64 . 
     FIGS. VIII-A and VIII-B illustrate still another embodiment of a wing-type sleeve of the invention. Both figures are elevation views with FIG. VIII-B illustrating the sleeve of FIG. VIII-A after it has been rotated 90° about the y-y axis. The sleeve  72  is provided with a flange  74 , two blades  78 , two wings  76  and a longitudinal slit  73 . It should be noted that this sleeve does not have a foot or a web. And when such sleeves are installed in a pre-drilled hole, the hole may be sized to cause the blades to move toward one another at the distal end of the sleeve. This results in more deflection of the blades into the bone and a tighter fit when a screw or pin is inserted into the sleeve. 
     FIGS. IX-A and IX-B illustrate a sleeve of the type shown in FIG. VII except that an annular recess  81  is provided to receive an optional annular ring  71  disposed in an annular groove on the shank  77  of pin  70 . When the pin is installed in the sleeve with a slight tap such as from a hammer, the annular ring  71  is snap fit into the annular recess  81  thereby holding the pin firmly in place. Head  75  of the pin  70  is seated in tapered portion  80  of the flange  84  when the pin is installed in the sleeve. Longitudinal slits  83  extend into the tapered bore  89 . 
     Referring to FIG. IX-C, after the sleeve is installed in a bone, the top surface of the pin is flush with the top surface of the sleeve and a countersink recess can be made in the cortical portion  91  of the bone so that the entire fastener is flush with the top surface of the bone. The installation of the pin  70  into the sleeve  82  causes the blades  88  and the wings  86  to move laterally into the cancellous portion  90  of the bone thereby firmly affixing the fastener in the bone. In the figure, the head of the pin is flush with the top surface of the flange and the cortical portion. Of course, other head designs which are not flush can be used. 
     FIG. IX-D illustrates a variation of FIG. IX-C wherein a longer pin  77  is used to affix a plate  94  to a bone. The cortical portion of the bone  93  is drilled to accommodate the flange  84  and the optional annular ring  71  is located on the pin  77  at a certain measured distance from head  79  so that the top surface of head  79  will be flush with the top surface of the plate  94  when the ring  71  is snap fit into sleeve  82  at annular recess  81 . The sleeve is affixed in the bone in the same manner as described in respect of FIG. IX-C wherein the blades  88  and the wings  86  are laterally extended into the cancellous portion  92  of the bone. 
     FIG. X is a perspective view of a sleeve  102  installed in a countersink  103  in a plate or tibial tray  104 . Comparing FIG. IX-D, this is a different way of using the fastener of the invention in combination with a plate because in this case the sleeve is countersunk in the plate and affixed in the bone. In FIG. IX-D the sleeve is fixed only in the bone and the pin secures the plate. 
     FIGS. XI-A, B and C illustrate sleeve  112  having a flange  114  at the proximal end, a foot or web  115  at the distal end, threads  116  and anti-rotation wedges  117 . Opening  120  provides access to cavity  119 . There are no longitudinal slits or blades as required of the other sleeves of the invention. Sleeve  112  can be used as a plug and the cavity can optionally be filled with any form or combination of bone, coral, PEEK chips, allograph, ceramics, bone wax, medications such as antibiotics, bioactive materials, antibacterial compositions, immunostimulating agents, tissue or bone growth enhancers and other active and inactive ingredients and pharmaceutical materials known in the art. A suitable screw, pin or plug is used to close opening  120  after the sleeve is implanted and the cavity has been optionally filled with a foregoing material. This sleeve can have any desired shape or size as with the other sleeves of the invention. The sleeve optionally can be made from a bioabsorbable material which will gradually dissolve and cause the contents to be released over time. The other sleeves of the invention which have longitudinal slits and blades can be used in the same manner as sleeve  112  wherein the slits will allow for more rapid release of any active materials that may be filled into the internal bore. The slits also permit faster bone growth. When a sleeve of the invention is used as a plug as described herein it is normally used to fill a hole created by a previous procedure such as the removal of implants of various kinds such as screws, halos and the like. The plugs can stop bleeding, prevent infection, enhance bone growth and perform various other beneficial functions. 
     FIG. XII-A-J illustrates top views of some of the head design types for screws and pins that can be used in the invention and some of the design types for the flanges. These illustrations are not intended to include all of the possible designs and others can be used as will be apparent to those skilled in the art. All of the illustrated designs can be used for flanges or pin heads and FIGS. XII-A-I can be used for screws. It will be understood by those having skill in the art based upon the disclosures herein that that when any of the designs are used for a flange they will also include an opening for a screw or a pin. An example of such an opening being the opening  19  in a flange having an internal hex as illustrated in FIG. IC. FIG. XII-A illustrates a standard slot. FIG. XII-B can be a Philips or a cruiform. FIG. XII-C is a spanner and D is a torq. FIG. XII-E is an Allen, F is a square head and G is an external hex. FIG. XII-H is a new design, I is an internal hex and J is a pin head or flange. 
     FIG. XIII-A illustrates in elevation a pin  123  with head  126  and FIG. XIII-B illustrates in elevation a screw  133  with a head  135 , a retaining ring  137  disposed in an annular ring on the shank and threads  139  disposed on said shank. These are intended to show some alternative embodiments to those screws and pins already illustrated. Variations thereon will be apparent to those skilled in the art. Either the pin  123  or the screw  133  could be used, for example, with the sleeve of FIGS. IX-A and B. The retaining ring  137  illustrated on the screw  133  prevents rotation and loosening of the screw after it is installed in the sleeve, but the retaining ring does not prevent the intentional removal of the screw by a surgeon.