Patent Publication Number: US-9421058-B2

Title: Bone fixation system

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 14/694,075, filed Apr. 23, 2015, which is a divisional of U.S. patent application Ser. No. 13/078,188, filed Apr. 1, 2011, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/417,614 filed Nov. 29, 2010, and further claims the benefit of U.S. Provisional Patent Application Ser. No. 61/320,883 filed Apr. 5, 2010, the disclosures of all of which are hereby incorporated by reference as if set forth in their entirety herein. 
    
    
     BACKGROUND 
     Fractured bones are a common injury seen in trauma centers. Surgeons in trauma centers frequently encounter many different types of fractures with a variety of different bones. For stabilizing a bone fracture, a metal fixation plate with suitable holes is fixed to bone fragments on opposing sides of the fracture using metal screws or pins. Typically the screws are self-cutting and are rotated into threadless openings in the bone, or they are screwed into pre-drilled threaded openings. Fracture fixation using such plates and screws may include several procedural steps and several instruments. For example, a first instrument may be used to cut the holes in the bone, and then a second instrument may be used to place the screws or pins. Therefore, the complexity and duration of the surgery may be unnecessarily lengthy and complex. 
     SUMMARY 
     Disclosed is a surgical fastener may include a body that includes a first portion and a second portion. The body may define a bore that extends through at least the first portion along a longitudinal axis of the body. The bore may be configured to receive a cutting mechanism. The first portion of the body may be transmissive to electromagnetic radiation and the second portion of the body may be absorptive to electromagnetic radiation such that upon absorbing electromagnetic radiation the second portion of the body softens and is capable of deforming. In one embodiment, the body defines a proximal end and a distal end spaced from the proximal end along the longitudinal axis, the proximal end is configured to attach to a surgical device that emits an energy source, and the first portion is disposed proximally with respect to the second portion. In another embodiment, the first portion may be an inner core portion and the second portion may be an outer peripheral portion. 
     The surgical fastener may be part of a kit that includes both a bone plate and at least one polymer based fastener. The bone plate may be comprised of a thermoplastic material. The fastener may include a body that defines a first portion, and a second portion. The second portion may have laser absorbing properties. The fastener may also include a bore that extends through at least the first portion of the body. The bore may be configured to receive a cutting mechanism. 
     Also disclosed is a surgical device configured to implant a surgical fastener into a target anatomical location. The surgical device may include a hand piece having a body that is configured to support a fastener that has a body and a bore that extends through the body. The surgical device may also include a cutting mechanism and an energy source. The cutting mechanism may be configured to extend through the bore of the fastener and cut into a target anatomical location. The energy source may be configured to heat and soften a portion of the fastener. 
     Also disclosed is a method of fixation of a surgical fastener to a target anatomical location. According to the method a hole may be cut into the target anatomical location by using a cutting mechanism of a surgical device. A fastener that is attached to a tip of the surgical device may be advanced into the hole of the boney structure as the cutting mechanism is cutting the hole. An energy source of the surgical device may then be activated to thereby heat the fastener so as to soften at least a portion of the fastener. Once finished the surgical device may be removed while the fastener remains attached to the boney structure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of preferred embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the surgical fasteners and devices of the present application, there is shown in the drawings preferred embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings: 
         FIG. 1  is a schematic view showing a surgical device fixating a bone plate to bone with a surgical fastener; 
         FIG. 2A  is a longitudinal cross-sectional view of a surgical fastener according to one embodiment, the surgical fastener having a core portion and a peripheral portion capable of deforming; 
         FIG. 2B  is a transverse cross-sectional view of the surgical fastener shown in  FIG. 2A , the core portion and the peripheral portion are joined such that the surgical fastener is configured as a one-piece fastener; 
         FIG. 2C  is a transverse cross-sectional view of the surgical fastener shown in  FIG. 2A , the peripheral portion being a coating disposed on the core portion; 
         FIG. 3A  is a front elevational view of a surgical fastener in accordance with another embodiment, the surgical fastener having a distal portion capable of deforming; 
         FIG. 3B  is a longitudinal cross-sectional view of the surgical fastener shown in  FIG. 3A ; 
         FIG. 3C  is a transverse cross-sectional view of the surgical fastener shown in  FIG. 3A , including an optical waveguide extending through the bore of the fastener; 
         FIG. 3D  is a front elevational view of a surgical fastener in accordance with another embodiment, the surgical fastener including closed irrigation channels; 
         FIG. 4A  is a side elevational elevation view of a surgical device configured to affix a bone plate to bone using a surgical fastener; 
         FIG. 4B  is a schematic view showing a first laser, a second laser and an irrigation supply of the device shown in  FIG. 4A ; 
         FIG. 4C  is a detailed side view illustrating the tip of the device shown in  FIG. 4A  holding a surgical fastener for affixing a bone plate to bone; 
         FIG. 4D  is a detailed side view illustrating the tip of the device shown in  FIG. 4A  holding another embodiment of the surgical fastener for affixing a bone plate to bone; 
         FIG. 5A  is a schematic view of a surgical device being positioned to affix a bone plate to bone; 
         FIG. 5B  is a schematic view of the surgical device shown in  FIG. 5A  activating a first laser to drill through the bone plate and bone, and simultaneously advancing a surgical fastener; 
         FIG. 5C  is a schematic view of the surgical device shown in  FIG. 5B  activating a second laser to soften at least a portion of the surgical fastener; and 
         FIG. 5D  is a schematic view showing the surgical fastener affixing the bone plate to bone after the surgical device is removed. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG. 1 , a bone fixation system  10  includes a plate  14 , one or more fasteners  18  configured to attach the plate  14  to a target anatomical location such as bone  26 , and a surgical device  22  that facilitates the attachment of the plate  14  and the fasteners  18 . It should be appreciated that the bone  26  can include two or more fractured bone segments, such as bone segments  26 A and  26 B, or can include any other deformity amenable to treatment using bone fixation. Moreover, the target anatomical location may be structure other than bone, such as ligaments, and other soft or hard tissue structures. As shown, the plate  14  is placed over or onto the bone  26 , and the surgical device  22  may be positioned over the plate  14  to cut a hole in either the plate  14 , the bone  26 , or both, so as to affix the plate  14  to the bone  26  using the fastener  18 . The fixation of the plate  14  using one or more fasteners  18  and the surgical device  22  may be performed using a single device. For instance, only a single device  22  can be used to cut a hole, place the fastener  18 , and affix the plate  14  to the bone  26  with the one or more fasteners  18 . It should be understood that the entire fixation system  10  may be sold as a kit or alternatively, the plate  14 , and the one or more fasteners  18  may be sold as a kit themselves. For instance, a plurality of fasteners  18  having different sizes and/or shapes can be provided as a kit. 
     Alternatively or additionally, a plurality of plates  14  having different sizes and/or shapes can be provided as a kit. Alternatively or additionally still, a combination of fasteners  18  and plates  14  having the same or different sizes and/or shapes can be provided as a kit, either alone or in combination with the surgical device  22 . Furthermore, while the fasteners  18  are illustrated as pins, they can alternatively be provided as screws having threaded surfaces, nails having smooth or toothed surfaces, bolts, or any alternative fixation device configured to fix the bone plate  14  to the underlying bone  26 . 
     As shown in  FIG. 1 , the surgical device  22  includes a hand piece  82 , and a control unit  86  that is connected to the hand piece  82  by a cord  90 . The control unit supplies a cutting mechanism  46  that is configured to cut the holes into the plate  14  and the bone  26 , and an energy source  70  that is configured to heat and soften the fasteners  18  to thereby attach the plate  14  to the bone  26 . The cutting mechanism  46  may include a first laser  94  and an irrigation system  98 , and the energy source  70  may include a second laser  102 . The first laser  94 , the irrigation system  98  and the second laser  102  are arranged in the control unit  86  and delivered to the hand piece  82  of the surgical device  22  through the cord  90 . 
     The plate  14  provides a load bearing structure that can be connected to bone fragments. The plate  14  is preferably made from a polymer material. For example the plate  14  may be made from poly-alpha-hydroxyester, polyorthoester, polyanhydride, polyphosphazenes, poly(propylenefumarate), polyesteramide, polyethylenefumarate, polylactide, polyglycolide, polycaprolacton, trimethylenecarbonate, polydioxanone, polyhydrobutyrate, as well as their copolymers and mixtures. The plate  14  may also include electromagnetic radiation absorption properties. For example, the plate  14  may include an additive, such as chlorophyll, carbon black, iron oxide, graphite, fluorescein, methylene blue, indocyanine green, eosine; eosine Y (514 nm), ethyleosine (532 nm), acridine, acridine orange, copper phtalocyanine, chrome-cobalt-aluminum oxide, ferrous ammonium citrate, pyrogallol, logwood extract, chlorophyll-copper complex, D&amp;C blue No. 9, D&amp;C green No. 5, [phtalocyaninate(2-)] copper, D&amp;C blue no. 2, D&amp;C blue no. 6, D&amp;C green no. 6, D&amp;C violet no. 2, and D&amp;C yellow No. 10, which allows the plate  14  to absorb energy such as heat from the second laser  102 . In operation, the portion of the plate  14  that has the electromagnetic radiation absorption properties, absorbs the laser beam and deforms, thereby contributing to the fixation of the plate  14  to the bone  26 . In another embodiment, the electromagnetic radiation absorbing component may include magnetic nano-particles, and the second laser  102  may be replaced by an electromagnetic transmitter that emits an electromagnetic signal in the range of 20 kHz to 10 GHz. Alternatively, ultrasonic vibrations, a conventionally heated metal bolt or heated air flow might be used for melting the fastener/plate. 
     Further, the plate  14  may be provided without predrilled holes and thus may define a continuous surface between opposing edges along a length that defines a target location for the insertion of one or more of the fasteners  18 . During installation, the cutting mechanism of the surgical device  22  may be used to produce holes in the plate  14 . It should be understood, however, that the plate  14  is not limited to plates defining continuous surfaces, and may be provided with pre-drilled holes. Furthermore, it should be understood by one of skill in the art, that the plate  14  and the holes may be provided in a variety of shapes and sizes. 
     As shown in  FIGS. 2A-2C  each surgical fastener  18  includes a body  44  that is elongate in a longitudinal direction L and defines a distal end D and a proximal end P. Each surgical fastener  18  further includes a bore  48  that extends through the body  44  in the longitudinal direction L and along a longitudinal axis  49  that may define a central axis of the fastener  18 . In this way, the body  44  is tubular having an outer diameter D 1  that defines an external surface  55  of the body  44 , and an inner diameter D 2  that defines an internal surface  52  of the body  44 . As shown, the body  44  may be separated into a first or core portion  50  adjoining the internal surface  52 , and a second or peripheral portion  51  adjoining the external surface  55 . 
     The body  44  of the fastener  18  is made from a thermoplastic material, for example poly-alpha-hydroxyester, polyorthoester, polyanhydride, polyphosphazenes, poly(propylenefumarate), polyesteramide, polyethylenefumarate, polylactide, polyglycolide, polycaprolacton, trimethylenecarbonate, polydioxanone, polyhydrobutyrate, as well as their copolymers and mixtures. The peripheral portion  51  of the body  44  adjoining the external surface  55  is colored sufficiently to include electromagnetic radiation absorption properties while the core portion  50  of the body  44  adjoining the internal surface  52  is transmissive to the electromagnetic radiation provided by the energy source. For example, the colored peripheral portion  51  may include an additive, such as chlorophyll, carbon black, iron oxide, graphite, fluorescein, methylene blue, indocyanine green, eosine; eosine Y (514 nm), ethyleosine (532 nm), acridine, acridine orange, copper phtalocyanine, chrome-cobalt-aluminum oxide, ferrous ammonium citrate, pyrogallol, logwood extract, chlorophyll-copper complex, D&amp;C blue No. 9, D&amp;C green No. 5, [phtalocyaninate(2-)] copper, D&amp;C blue no. 2, D&amp;C blue no. 6, D&amp;C green no. 6, D&amp;C violet no. 2, and D&amp;C yellow No. 10, which allows absorption of electromagnetic radiation provided by the second laser  102 . 
     By absorbing the energy of the second laser  102 , the thermoplastic material of the peripheral portion  51  heats up and softens. That is, the softening of the fastener  18  occurs by the heat generated by the absorption of radiation from the second laser  102 , to the point that allows the fastener  18  to be deformed. In particular, the additive, and in some cases some of the thermoplastic itself absorbs the laser and heats up to thereby cause the thermoplastic to soften. The softened thermoplastic material is capable of deforming and expanding into the hollow spaces of the bone tissue thereby affixing the fastener  18  and the plate  14  to the bone  26 . The peripheral portion  51  may absorb at least twice as much irradiated energy as the core portion  50 . Typically, however, a factor of 5-1000 times more energy is absorbed in the peripheral portion  51  with respect to the core portion  50 . In other words, the peripheral portion  51  may absorb 50-100% of the energy, while the core portion  50  absorbs 0-10%. The thickness of the peripheral portion  51  is preferably over 0.1 mm and/or between 1 to 20% of the outer diameter D 1 . It should be understood that the peripheral portion  51  is not limited to thermoplastic materials capable of absorbing the second laser  102  and that other materials may be used. For example, the peripheral portion  51  may include magnetic nano-particles, and the laser can be replaced by an electromagnetic transmitter that emits an electromagnetic signal in the range of 1 kHz to 1 MHz or 100 KHz to 100 GHz. 
     The core portion  50  of the fastener  18  which is transmissive to the electromagnetic radiation may be configured so as not to warm-up at all or only partially, and to maintain its mechanical strength. At the same time, the core portion  50  can serve as an optical element and transmit the energy onward into the bone plate  14 . The fastener  18  can then be pushed into a previously produced hole which may be undersized, and the warmed-up, softened polymer is then pressed into the interspaces of the bone. After turning off the energy source, the polymer (thermoplastic material) cools off and quickly hardens (&lt;1-2 minutes), and the mechanical interdigitation between the fastener  18  and the bone and/or the bone plate  14  is established. 
     The core portion  50  and the peripheral portion  51  may be separate discrete components that are coupled together with the peripheral portion  51  e.g. being a coating that includes the electromagnetic radiation absorbing properties as shown in  FIG. 2C , or they may be integral and thus one component, with the peripheral portion  51  comprising a chromophore (i.e. color or pigment) as shown in  FIG. 2B . Further, in some embodiments, the peripheral portion  51  may be a zone with a variable absorption coefficient “a”. In any case, the peripheral portion  51  includes the electromagnetic radiation absorbing properties sufficient to cause the peripheral portion  51  to deform in response to exposure to the first laser  94 , while the region of thermoplastic material of the core portion  50  has a transparency to the second laser  102  that is greater than that of the peripheral portion  51 . Therefore, the inner uncolored core portion  50  substantially maintains its structural integrity when exposed to the first laser  94  that deforms the peripheral portion  51 . 
     As shown in  FIGS. 3A-3D , in another embodiment, a fastener  18 A includes a body  44 A having first and second portions that are aligned with respect to a direction that extends substantially parallel to the longitudinal axis  49 . As shown in  FIG. 3B , the body  44 A of the fastener  18 A may include a first axial portion  64  and a second axial portion  60  disposed distally with respect to the first portion  64 . The first portion  64  may be transmissive to electromagnetic radiation, while the second portion  60  may be configured to absorb electromagnetic radiation. 
     As with the fastener  18 , fastener  18 A may be made from a thermoplastic material. For example each fastener  18 A may be made from poly-alpha-hydroxyester, polyorthoester, polyanhydride, polyphosphazenes, poly(propylenefumarate), polyesteramide, polyethylenefumarate, polylactide, polyglycolide, polycaprolacton, trimethylenecarbonate, polydioxanone, polyhydrobutyrate, as well as their copolymers and mixtures. The second axial portion  60  can be colored throughout its complete volume, and includes electromagnetic radiation absorption properties that allow the second portion to absorb energy provided by for example the laser  102 , and the first axial portion  64  is transmissive to the energy provided by the laser  102 . For example, the colored second portion  60  may include an additive, such as chlorophyll, carbon black, iron oxide, graphite, fluorescein, methylene blue, indocyanine green, eosine; eosine Y (514 nm), ethyleosine (532 nm), acridine, acridine orange, copper phtalocyanine, chrome-cobalt-aluminum oxide, ferrous ammonium citrate, pyrogallol, logwood extract, chlorophyll-copper complex, D&amp;C blue No. 9, D&amp;C green No. 5, [phtalocyaninate(2-)] copper, D&amp;C blue no. 2, D&amp;C blue no. 6, D&amp;C green no. 6, D&amp;C violet no. 2, and D&amp;C yellow No. 10, which allows absorption of electromagnetic radiation provided by the second laser  102 . In operation, the thermoplastic material in the complete volume of the second axial portion  60  of the fastener  18 A absorbs the laser beam and deforms, thereby affixing the plate  14  to the bone  26 . In another embodiment the second axial portion  60  may include magnetic nano-particles, and the first laser may be replaced by an electromagnetic transmitter that emits an electromagnetic signal in the range of 20 kHz to 10 GHz. 
     The first axial portion  64  and the second axial portion  60  may be separate discrete components that are coupled together, or they may be integral and thus one component, with the second axial portion  60  having a coating that includes the electromagnetic radiation absorbing properties. In either case, the second axial portion  60  includes the electromagnetic radiation absorbing properties sufficient to cause the second axial portion  60  to deform in response to exposure to an energy source such as the laser beam  102 , while the thermoplastic material of the first axial portion  64  has a transparency to the laser beam  102  that is greater than that of the second axial portion  60 , such that the uncolored first axial portion  64  substantially maintains its structural integrity when exposed to the laser beam  102  that deforms the second axial portion  60 . The second axial portion  60  is shown in  FIG. 3B  as being disposed at the distal end “D” of the body  44 , and the first axial portion  64  is illustrated as being disposed proximal with respect to the second axial portion  60 . The colored second axial portion  60  may be from 10 to 80% of the overall length of the fastener  18 A along the longitudinal direction. 
     As shown in  FIGS. 3A-3D , the fasteners may be provided with irrigation channels  59  configured as recesses  56  or closed passages  57  as illustrated in  FIGS. 3A and 3D . As shown in  FIGS. 3A and 3B , a fastener  18 A includes a hollow-cylindrical body  44 A that is elongate along a longitudinal axis  49 . The body  44 A includes an external surface  55 A that defines an outer diameter D 1 . As shown, each fastener  18 A includes a bore  48 A that extends through the body  44 A in the direction of the longitudinal axis  49 . As shown, the bore  48 A has an inner diameter D 2  that defines an internal surface  52 A of the body  44 A. The body  44 A further defines a plurality of irrigation channels  59  configured as recesses  56  that extend into the internal surface  52 A along the entire length of the bore  48 A from the proximal end P to the distal end D. While the body  44 A is illustrated as defining three circumferentially equidistantly spaced recesses  56  (i.e. disposed at 120° when viewed in cross-section), the body  44 A can include any number of recesses  56  as desired spaced circumferentially about the body  44 A as desired. As shown in  FIG. 3A , in cross-section, each recess  56  may be in the shape of a half circle and may be configured to receive and carry an irrigation fluid. Each recess  56  may have a radius of about 0.1 mm to about 0.5. The recesses  56  may be radially spaced apart from each other to provide a number of irrigations channels  59  that allow an irrigation fluid to be injected through e.g. two of the three irrigation channels  59  and to be sucked off through e.g. one of the three irrigation channels  59 . It should be understood, however, that the recesses  56  are not limited to being half circles and may be any shape capable of receiving an irrigation liquid. 
     In another embodiment and as illustrated in  FIG. 3D  the fasteners may include irrigation channels  59  that are closed passages  57 . As shown, a fastener  18 B includes a tubular body  44 B, a bore  48 B that extends through the body  44 B, and three circumferentially equidistantly spaced closed passages  57  that extend through the body  44 B between an internal surface  52 B and an external surface  55 B of the body  44 B, such that no communication to the bore  48 B exists. While the body  44 B is illustrated as defining three circumferentially equidistantly spaced passages  57 , the body  44 B can include any number of passages  57  as desired spaced circumferentially about the body  44 B as desired. 
     The fasteners  18 ,  18 A, and  18 B may be provided in a variety of sizes. For example, the outer diameter D 1  of each fastener may be between 1.5 and 5 mm and the bores of the fasteners may have a diameter D 2  of about 0.4 mm to 3 mm. Furthermore, the fasteners may have a length T extending along the longitudinal axis  49  that is between about 3 mm and about 20 mm long. The dimensions provided are for illustrative purposes only, and it should be understood that the fasteners may include any dimension capable of affixing the plate  14  to the underlying bone  26 . 
     The color material or particles may be worked into the polymer of the fasteners using a variety of methods. For example, color-containing polymer layers or implant elements can be produced in a so-called two-component injection molding process. In this case, the uncolored portion of the fastener is injected in a first phase, and after modifying the cavity in the injection mold, the color containing portion is injected in a second phase. 
     The layers of color-containing polymer may also be achieved by applying and drying the color and polymer containing solutions. It is in this case possible to achieve layers of color containing polymer by depositing and drying the color and polymer containing solutions, similar to a candle-drawing process (dip-coating process) or by spraying. The use of the first-mentioned depositing process allows achieving layers of a very thin (micrometer-thin) up to a very thick (sub- and millimeter range) size. 
     The color layer(s) may also be achieved by applying and drying color-particles containing suspension or solution. In this case, the coating occurs by first warming-up the color-containing particles. The heated particles may then be jetted onto the surface of the uncolored part of the fastener, so that the particles fuse with the polymer of the uncolored portion of the fastener and are fixated on the surface. 
     Ceramic or other non-thermally sensitive particles may also be applied to the surface by jetting them onto the polymer surface in a heated condition, where they can locally fuse with the polymer and be fixated in the surface. An example for this is given by the plasma spraying process by which hip joint prostheses are for instance coated with calcium phosphate particles. The use of processes such as Chemical Vapor Deposition (CVD) or Physical Vapor Deposition (PVD) is also conceivable in the presence of suitable substrates. 
     Each fastener may be positioned and affixed to the plate  14  and the bone  26  using the surgical device  22  shown in  FIGS. 4A-4C . As shown, the surgical device  22  includes a hand piece  82 , a control unit  86 , and a cord  90  connecting the hand piece  82  to the control unit  86 . The surgical device  22  is a processing apparatus configured to provide both the cutting mechanism  46  and the energy source  70 . In the embodiment shown, the cutting mechanism includes a first laser  94  and an irrigation supply  98  that is connected to a first optical waveguide  95 , while the energy source  70  includes a second laser  102  that is connected to a second optical waveguide  103 . The first laser  94  and irrigation supply  98  may be configured to cut through the plate  14 , the bone  26 , or both, and the second laser  102  may be configured to heat and deform the second axial portion  60  or the tubular peripheral portion  51  of the fasteners  18 ,  18 A, and/or  18 B. The irrigation supply  98  is configured to supply a coolant liquid and to remove the debris from the cutting site. The optical waveguides  95 ,  103  may be flexible or rigid optical light-transmitting structures, such as for instance glass fiber cables or reflecting hoses (e.g. also nano-tubes) used to transmit electromagnetic radiation from the source to the fastener. On the other hand, the fastener itself may serve as an optical fiber and light diffuser. After entering the fastener, the light is transmitted through the first portion of the fastener until it arrives at the point where the softening of the polymer, mostly at its surface, is to take place. In order to transmit the light through the optical fiber to the fastener up to the desired point, the fastener may on one hand actually transmit the light, meaning for instance to the tip of a pin and then distribute it there, so as to reach the surface of the fastener, for instance by diffusion. 
     In one embodiment, the first laser  94  is a 3 μm infrared laser, the irrigation supply  98  uses a liquid such as water, and the second laser  102  is an 800 nm infrared laser. It should be understood, however, that the device  22  is not limited to a cutting mechanism  46  comprising the 3 μm infrared laser, and water supply, nor is it limited to an energy source  70  comprising the 800 nm infrared laser. For example, the cutting mechanism  46  may also be a 10 μm CO 2  laser combined with an irrigation supply, or a 2.8 μm Erbium YAG laser combined with an irrigation supply. Similarly, the second laser  102  may be a laser having a wave length in the range of 400 nm to 1800 nm or it may be replaced by an electromagnetic transmitter in the range of 20 kHz to 10 GHz, or both infrared lasers may be replaced by an ultrasonic source capable of both: (i) cutting through the plate  14 , and the boney structure  26 , and (ii) heating and thereby softening the fastener  18 . 
     The control unit  86  includes each of the first laser  94 , the irrigation supply  98 , and the second laser  102 . The control unit  86  can include settings that are controlled by a user to determine the operation of the bone fixation system. For example, a user may at first set the control unit  86  to simultaneously supply the first laser  94 , and the irrigation supply  98 , to cut through the plate  14  and the bone  26 , and then mid-procedure, change the control unit  86  to supply the second laser  102  to deform the fastener  18 . 
     As shown in  FIGS. 1, and 4A-4C , the hand piece  82  includes an elongated body  110  having a tip  114  at its distal end and a connecting portion  118  at its proximal end for connecting the body  110  to the cord  90 . The elongated body  110  is generally a tube-like structure that is constructed to contain said first and second waveguides  95 ,  103  and/or irrigation tubes  126   a ,  126   b , as shown in  FIG. 4C . The first and second optical waveguides  95 ,  103  may be optical fibers, which are configured to transmit the beams of the first and second laser  94  and  102  from the control unit  86  through the body  110  and to the tip  114 . Similarly, the irrigation tubes  126  are configured to transport the irrigation liquid from the control unit  86  through the body  110  and to the tip  114  and to suck the irrigation fluid off in the reverse direction, and can thus also be referred to as irrigation tubes. A fiber tip end  130  proximate to the distal end of the fastener disperses the beam of the first laser  94  as desired so as to allow the hole that is cut into the plate  14  and bone  26  to have a diameter that allows the fastener to pass through. The fiber tip end  130  can give way several mm back into the device  22 , to enable compression of the second axial portion  60  of the fastener inside the boney structure  26 . For example, as the fastener is compressed down by a user, the fiber tip end  130  may be retracted proximally either by translating proximally with respect to the handle, or by compressing, as a portion of such as the axial portion  60  of the fastener  18 A compresses or otherwise deforms. 
     Referring also to  FIG. 3C , the first optical waveguide  95  is configured to extend through the bore  48  of the body  44  of the fastener  18 . In particular, the first optical waveguide  95  defines a diameter that is substantially equal to the diameter of the bore  48 . Thus, the bore  48  of the fastener  18  is sized to receive the first optical waveguide  95  that guides the beam of the first laser  94  such that there is little clearance between the first optical waveguide  95  and the internal surface  52  of the bore  48 . As a result, the first optical waveguide  95  substantially closes the inner radial ends of each of the recesses  56  so as to define a plurality of irrigation channels  59 , which extend along the length of the fastener  18 . 
       FIG. 4C  illustrates a tip  114  configured to be used with a fastener such as fastener  18 , as shown in  FIG. 2A , and fasteners  18 A, and  18 B including irrigation channels  59  as shown in  FIGS. 3A and 3D . The tip  114  is configured to grip and hold or otherwise support the fasteners. The proximal end P of the fastener  18  can comprise an attachment portion  45  that can be e.g. configured as a cylindrical portion dimensioned for a press fit with a corresponding bore  140  in the tip  114 . As shown, the tip  114  includes a channel  144  extending from a wall  146  and toward the distal end of the tip  114 , and a bore  140  that extends proximally from the distal end of the tip  114  in alignment with the channel  144 . The bore  140  defines a diameter greater than that of the channel  144 , such that the tip  114  provides a seat  148  at the interface between the bore  140  and the channel  144 . The interface abuts and supports the fastener  18  at the distal end of the channel  144  when the fastener  18  is fully inserted or otherwise disposed in the bore  140 . The channel  144  is separated into an injection segment  145   a  for injecting an irrigation liquid and a suction segment  145   b  allowing to suck off the irrigation liquid together with the debris. The hand piece body  110  further includes a first and a second port  150 ,  151  extending into the tip  114 . Each of the first and second ports  150 ,  151  has a coupling  154  at its proximal end for coupling an irrigation tube  126   a ,  126   b  thereto and an opening  158  at its distal end. The openings  158  of the first and second port  150 ,  151  extend into the channel  144  so as to place the channel  144  in fluid communication with the couplings  154  of the first and second port  150 ,  151 . 
     The bore  140  is sized to receive and hold a fastener such as fasteners  18 A or  18 B as described above, and the channel  144  is configured to guide the irrigation liquid of the irrigation supply  98  from the port opening  158  to two irrigation channels  59  of the fastener which can be recesses  56  or closed passages  57  and to suck the irrigation fluid and the debris off through the third irrigation channel  59  of the fastener  18 . 
     A first irrigation tube  126   a  is connected to the coupling  154  of the first port  150 , and the irrigation liquid of the irrigation supply  98  travels through the first irrigation tube  126   a , into the injection segment  145   a  of the channel  144  via the first port  150  and through two irrigation channels  59  of the fastener. A second irrigation tube  126   b  is connected to the coupling  154  of the second port  151 , and the irrigation fluid with the debris can be sucked off through the third irrigation channel  59  of the fastener  18  defined by the third irrigation channel  59  into the suction segment  145   b  of the channel  144  and via the second port  151  into the second irrigation tube  126   b.    
     The beam of the first laser  94  and the irrigation liquid of the irrigation supply  98  may simultaneously travel longitudinally through the fastener  18 A and out the distal end D of the fastener  18 A to thereby cut the hole into the plate  14  and/or the bone  26 . As shown, the beam of the second laser  102  may be guided to a front or proximal wall  160  of the fastener  18 A. When the second laser  102  is activated, the light travels through the transparent first axial portion  64  of the fastener  18 A, and is absorbed by the laser absorbing second axial portion  60 . Alternatively, when using a fastener  18  according to  FIGS. 2A to 2C  the light travels through the thermoplastic material in the core portion  50  and is absorbed by the laser absorbing colored thermoplastic material of the peripheral portion  51  adjoining the external surface  55  of the fastener  18 , and by the adjacent portion of the plate  14 . 
     The tip  114  may be a sterile single use part that may consists of a fastener, such as anyone of fasteners  18 ,  18 A, or  18 B and the fiber tip end  130  that is configured to adequately cut through the bone  26  (note that the fiber tip end may be shaped in a way to disperse the laser beam, so that it is actually possible to drill a hole that is large enough to fit the fastener—which is larger than the fiber tip. The single use part may be configured to be selectively attached to or detached from a distal end of the body  110 . The single use part may also be made from a material that is capable of being placed in an autoclave. 
       FIG. 4D  illustrates another embodiment of the tip  114  configured to be used with a fastener  18  as illustrated in  FIGS. 2A to 2C . The embodiment of the tip  114  according to  FIG. 4D  differs from the embodiment of  FIG. 4C  only therein that the tip  114  comprises a sleeve  156  affixed to the tip  114  and comprising two or more bore holes  157  in fluid communication with the channel  144 . The sleeve  156  can be inserted into the bore  48  of the fastener  18  and surrounds the first optical waveguide  95 . The two or more bore holes  157  are arranged circumferentially equally spaced and suitable to guide the irrigation liquid of the irrigation supply  98  from the channel  144  to the tip  130 . The channel  144  is separated into an injection segment  145   a  for injecting the irrigation liquid and a suction segment  145   b  allowing to suck off the irrigation liquid together with the debris. The injection segment  145   a  is configured to guide the irrigation liquid of the irrigation supply  98  from the port opening  158  through two or more bore holes  157  in the sleeve  156  that is inserted in the bore  48  of the fastener  18  and the suction segment  145   b  is configured to suck the irrigation fluid and the debris off through one or more of the bore holes  157  in the sleeve  156 . 
     In operation and in reference to  FIGS. 5A-5D  the surgical device  22  may affix the plate  14  and the fastener  18  (or  18 A or  18 B) in a simple and efficient manner. As shown in  FIG. 5A , the fastener  18  is placed into the tip  114  of the hand piece  82  such that the fastener  18  partially extends distally of the tip  114 , and the plate  14  is positioned on the bone  26  over the fractured area. The hand piece  82  along with the fastener  18  may then be positioned on the surface of the plate  14  and at an angle of 90° with respect to the plate  14 , or offset with respect to the 90° angle if desired. Once the hand piece  82  is positioned, the control unit  86  may be activated to cause the beam of the first laser  94  and the irrigation supply  98  to cut or drill a hole  55  through the plate  14  and into the bone  26  if desired. As shown in  FIG. 5B , the first laser  94  and the irrigation liquid of the irrigation supply  98  travel through the bore  48  of the fastener  18  and out a distal end of the fastener  18 . As the hole  55  is being cut, the hand piece  82  and thus the fastener  18  may be gently pushed into the hole as it is created over time. 
     Once the desired depth of the hole is reached and the fastener  18  is properly positioned within the hole, the control unit  86  may be switched to deactivate the first laser  94  and the irrigation supply  98 , and activate the second laser  102  to thereby deform a portion of the fastener  18 . As shown in  FIG. 5C , the beam of the second laser  102  may soften and deform the fastener  18  and the interface between the plate  14  and the fastener  18 . A gentle push of the device  22  in the direction of said longitudinal axis  49  into the hole  55  causes a portion of the fastener  18  to deform and define an outer dimension that is greater than that of the hole  55 . Thus, the fastener  18  transforms into a rivet  170  that couples the plate  14  to the bone  26 . 
     The bone fixation procedure described above can be performed to fix the bone plate  14  to one or more bone segments of the bone  26  that are separated by a fracture. For instance, the bone plate  14  is positioned over the fracture site or fracture sites, and one or more fasteners can couple the plate  14  to each bone segment in the manner described above. 
     As shown in  FIG. 5D , the device  22  may be removed, while the plate  14  and fastener  18  remain behind. The plate  14  and fastener  18  may be made from a resorbable material. 
     The foregoing description is provided for the purpose of explanation and is not to be construed as limiting the invention. While various embodiments have been described with reference to preferred embodiments or preferred methods, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Furthermore, although the embodiments have been described herein with reference to particular structure, methods, and embodiments, the invention is not intended to be limited to the particulars disclosed herein. Moreover, any of the embodiments described above can incorporate any structures or features of any of the other embodiments described above, as desired. Those skilled in the relevant art, having the benefit of the teachings of this specification, may effect numerous modifications to the invention as described herein, and changes may be made without departing from the spirit and scope of the invention as defined by the appended claims.