Methods and devices for trauma welding

The present invention provides a method for stabilizing a fractured bone. The method includes positioning an elongate rod in the medullary canal of the fractured bone and forming a passageway through the cortex of the bone. The passageway extends from the exterior surface of the bone to the medullary canal of the bone. The method also includes creating a bonding region on the elongate rod. The bonding region is generally aligned with the passageway of the cortex. Furthermore, the method includes positioning a fastener in the passageway of the cortex and on the bonding region of the elongate rod and thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway of the cortex.

FIELD OF THE INVENTION

The invention relates to the welding of biocompatible material within the body, and more particularly, to the use of ultrasonic energy to bond thermoplastic material intracorporeally to stabilize tissue, such as a fractured bone.

BACKGROUND OF THE INVENTION

Fractured bones are a common injury seen in trauma centers. Sports activities, vehicle accidents, industrial-type incidents, and slip and fall cases are just a few examples of how bones may become fractured. Surgeons in trauma centers frequently encounter many different types of fractures with a variety of different bones. Each bone and each fracture type may require unique procedures and devices for repairing the bone. Currently, a one-solution-fixes-all device is not available to repair fractured bones. Instead, surgeons may use a combination of bone screws, bone plates, and intramedullary rods.

Bone plates may be positioned internal to the skin, i.e. positioned against the fractured bone, or may be positioned external to the skin with rods connecting the bone and plate. Conventional bone plates are particularly well-suited to promote healing of the fracture by compressing the fracture ends together and drawing the bone into close apposition with other fragments and the bone plate. However, one drawback with plates and screws is that with the dynamic loading placed on the plate, loosening of the screws and loss of stored compression can result.

To reduce the potential of loosening, locking screws and a locking bone plate may be used. U.S. Pat. No. 5,085,660 to Lin discloses a locking plate system. The system has multiple locking pins, each with one end formed as a screw to lock in the pending fixation bones or vertebral tubercles, with another end defining rectangular or similarly shaped locking post having a threaded locking end. Near the locking post end, there is formed a stopping protrusion. A plate defines multiple locking bores disposed at one side to be placed over the locking post end until the plate reaches the stopping protrusion on the locking pin. The plate defines multiple threaded screwing bores near the other side to receive locking pin screw. Multiple locking devices fix the side of the plate having locking bores to the locking post end of its locking pins. Multiple screwing pins each have one end formed as a pin to be used for penetrating the threaded screwing bore to lock into the bone or the vertebral tubercle. Another end which forms a head is for holding against the threaded screwing bore of the plate. Threads are provided near the head for the screwing pins to be screwed within the threaded screwing bore of the plate.

An example of an external bone plate system is disclosed in U.S. Pat. No. 6,171,307 to Orlich. Orlich teaches an apparatus and procedure for the external unilateral fracture fixation, fracture compression or enlargement of osseous tissue with a metal or equivalent material slotted forked stick to hold and position the threaded pins in its length, inserted in the bone with multiple fastening slidable screws and their bolts to attach the pins to the slotted forked stick, a solid slidable cube to hold and position the slotted forked stick, a supporting axial bar, and an axial threaded bar. A preferred embodiment includes at least three slotted forked sticks that hold and fix, with the use of compression screws and their bolts, threaded pins that penetrate the proximal and distal fragments of the bone through both corticals. Another preferred embodiment includes slotted forked sticks that adapt to the threaded pins, introduced in the bone, at any degree of inclination or orientation that these pins might have with respect to the bone.

In addition to internal or external bone plates, surgeons sometimes use intramedullary rods to repair long bone fractures, such as fractures of the femur, radius, ulna, humerus, fibula, and tibia. The rod or nail is inserted into the medullary canal of the bone and affixed therein by screws or bolts. After complete healing of the bone at the fracture site, the rod may be removed through a hole drilled in the end of the bone. One problem associated with the use of today's intramedullary rods is that it is often difficult to treat fractures at the end of the long bone. Fastener members, such as bolts, are positioned through the cortical bone and into threaded openings in the rod. However, the number and positioning of the bolt/screw openings are limited at the tip of the rod because of the decreased surface area of the rod and the reduced strength at the tip of the rod. Therefore, fractured bone sections at the distal end of a femur, for example, may not be properly fastened to the intramedullary rod.

U.S. Pat. No. 7,018,380 to Cole discloses a femoral intramedullary rod system. The rod system is capable of treating a variety of femoral bone fractures using a uniform intramedullary rod design. The system generally comprises an intramedullary rod defining an opening having an upper surface and a transverse member including a bone engaging portion and a connection portion defining a thru-hole with the nail sized to pass therethrough. A pin is selectively coupled to the transverse member to rigidly assemble the transverse member to the nail when the nail is passed through the thru-hole and the pin is received within the opening. In an alternative design, an epiphyseal stabilizer is joined to the nail by a locking member.

Also, U.S. Pat. No. 6,228,086 to Wahl et al. discloses a modular intramedullary nail. The intramedullary nail apparatus comprises a nail having a proximal portion, a middle portion and a distal portion. The proximal portion has a longitudinal slot adapted to receive at least one fixing element and the distal portion has at least one transverse bore. The proximal portion has a longitudinal axial bore. The apparatus further includes a set of inserts, each of which is adapted to be inserted in the longitudinal bore. Each insert has at least one guiding bore, the orientation and position of which is different for each of the inserts.

While devices and methods currently exist for repairing a fractured bone, there is need for an improved fractured fixation system. The welding system of the present invention may be used with a variety of fracture types and a variety of different bones. Also, with the inventive system, time and complexity of bone repair surgery is reduced. Furthermore, often times conventional bone plates and rods implanted in the emergency room are implanted with the intent of removing the plates and rods when more thorough bone reconstructive surgery can be performed. The trauma welding system of the present invention allows surgeons to quickly and thoroughly remove temporarily implanted plates, rods, and fasteners from fractured bones.

SUMMARY OF THE INVENTION

The trauma welding system of the present invention provides for the stabilization of tissue and implants during trauma surgery. The system includes devices and methods for intracorporeal bonding of thermoplastic material. An energy source welds the thermoplastics to polymers, metals, ceramics, composites, and tissue. The energy source may be resistive heating, radiofrequency, ultrasound (vibratory), microwave, laser, electromagnetic, electro shockwave therapy, plasma energy (hot or cold), and other suitable sources.

The trauma welding system utilizes any material weldable within the human body. This material requires the characteristic of becoming soft and tacky with the application of energy. The energy and the technique used to weld the material within the body avoid tissue necrosis. Such material may include polymers and some ceramics, composites, and metals. The present invention contemplates the use of any of these materials; however, based on testing, polymeric material, such as PEEK is a preferred weldable material. PEEK is advantageous because of its desirable characteristics of being softened, reheated, molded and remolded with ultrasonic energy.

In accordance with one aspect of the present invention, there is provided a method for stabilizing a fractured bone. The method includes the steps of positioning an elongate rod in the medullary canal of the fractured bone and forming a passageway through the cortex of the bone. The passageway extends from the exterior surface of the bone to the medullary canal of the bone. The method also includes creating a bonding region on the elongate rod where the bonding region is generally aligned with the passageway of the cortex, positioning a fastener in the passageway of the cortex and on the bonding region of the elongate rod, and thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway of the cortex.

In accordance with another aspect of the present invention, a second method for stabilizing a fractured bone is provided. The method includes positioning an elongate plate on the exterior surface of the fractured bone, forming a passageway extending through the elongate plate and into the bone, positioning a fastener in the passageway, and thermally bonding the fastener to the bone while the fastener is positioned in the passageway.

In accordance with a further aspect of the present invention, there is provided a third method for stabilizing a fractured bone. The method includes the steps of positioning an elongate rod in the medullary canal of the fractured bone and positioning an elongate plate on the exterior surface of the bone such that the cortex of the bone is positioned between the elongate rod and plate. The method also includes forming a passageway through the elongate plate and the cortex of the bone. The passageway extends from the exterior surface of the elongate plate to the medullary canal of the bone. The method further includes creating a bonding region on the elongate rod where the bonding region is generally aligned with the passageway, positioning a fastener in the passageway and on the bonding region of the elongate rod, and thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway.

The elongate rod, elongate plate, and fastener may include thermoplastic material such as PEEK. Ultrasonic energy may be used to thermally bond the fasteners of the present to the bonding region of the elongate rod and/or elongate plate. The bonding region may be a roughened surface, an indentation, a channel (blind hole), or a thru-hole in the plate/rod.

When bonding the fastener to the plate/rod, the fastener may also be thermally welded to one or more cortex areas (cortical bone portions) of the bone whereby the fastener resists movement between the bone and plate/rod. Also, the fastener and implants such as bone plates and IM rods may be thermally contoured to conform to an adjacent surface or configuration.

DETAILED DESCRIPTION OF THE INVENTION

The trauma welding system of the present invention provides for the stabilization of damaged tissue, such as fractured bones. The system includes devices and methods for intracorporeal bonding of thermoplastic material. An energy source welds the material in place. The energy source may be resistive heating, radiofrequency, ultrasound (vibratory), microwave, laser, electromagnetic, electro shockwave therapy, plasma energy (hot or cold), and other suitable sources. Other energy sources, surgical procedures, and medical instruments which may be used with the present invention are disclosed in U.S. Provisional Patent Applications Nos. 60/765,857 filed Feb. 7, 2006 and 60/784,186 filed Mar. 21, 2006. The contents of these documents are incorporated by reference herein in their entirety.

The trauma welding system of the present invention contemplates the use of any material weldable within the human body. This material requires the characteristic of becoming gel-like, tacky, and soft with the application of energy. The energy and the technique used to weld the material within the body avoid damage to surrounding body tissue. Such material may include polymers, ceramics, composites, and metals. The present invention contemplates the use of any of these materials; however, polymeric material is used to describe many of the following embodiments.

The polymers used in the present invention, such as PEEK, have randomly arranged molecules allowing vibrational energy to pass through the material with little attenuation. As such, the material requires relatively little ultrasonic energy to make the material soften and become tacky. This small amount of energy or heat needed to bond PEEK avoids tissue necrosis. The transition period is longer in duration and therefore, when applying energy, the material gradually softens, passing from a rigid state through a transition state to a rubbery state and then to a flowable gel-like state. The amorphous features of these materials make them ultrasonically weldable with lower temperature and better welding points. To bond these materials, the true melting point does not need to be reached or exceeded, so there is less risk to surrounding body tissue. PEEK is also useful with the welding system of the present invention because it has a modulus of elasticity very close to bone. Also, some grades of PEEK have a hydrophilic component which permits hydrophilic interlocking when placed in the body.

The temperature, time, pressure, and other parameters may be closely monitored and controlled to achieve an effective weld. Also, because the material does not substantially melt (only the welding region softens and becomes tacky) the holding strength of the thermoplastic during and after welding is not jeopardized. That is, a fastener made of a thermoplastic which melts, like those in the prior art, can not maintain a compressive force against a component or implant during the welding process. This is because the material of the fastener becomes liquefied, and a fastener in liquid form can not maintain a compressive or tension force. The present invention contemplates implants made of PEEK which bond by softening or making tacky the polymer material at the bonding region. The remaining PEEK material does not flow and therefore retains its ability to maintain a compression or tension force.

There are several factors that effect welding of thermoplastic materials. One is hydroscopicity, the tendency of a material to absorb moisture. If too much fluid gets between the welded parts it can decrease the bond or create a foam which prevents proper bonding of the materials. Therefore, the welding of thermoplastics may be performed under vacuum/suction, or a hermetic seal may be placed around the thermoplastic during the welding process. Also, the welding may be performed using a cannula which prevents fluid from entering the welding area. Furthermore, pressure, such as air pressure or compression force, may be applied during welding to prevent entry of moisture or liquid.

In addition to or in place of reducing moisture from the welding area, certain agents can be used to aid in the bonding process. Such agents may include filler material, glass filler, glass fiber, talc, and carbon. The agents may be placed at the bond site as a temporary welding enhancement means or may be a permanent agent to enhance the bonding. For example, the agent may be placed within the bonding region of PEEK. The agent may be left in place to bond or could be removed. It is contemplated that any amount of agent may be used to enhance the bond strength of the thermoplastics. In an exemplary embodiment, the amount of agent may be about 10 to 20 percent.

Moisture may further be eliminated or prevented from entering the thermoplastic material through the use of desiccants. Desiccants may be added prior to or during the welding process. Also, the thermoplastic material may be stored using desiccant material to prevent change in thermal properties. It is contemplated that this moisture reducing means may be applied to any polymeric material.

Another factor effecting the welding of thermoplastic material is pigments, especially white and black coloring. In many materials used in medical applications, white pigment is added to the polymer to make it appear sterile. Some pigments negatively affect the welding characteristics of the material. In the present invention, pigment-free thermoplastics, such as PEEK, are thermally welded for proper bonding of the material.

Mold release agents also affect the welding properties of thermoplastics. Polymeric components are usually formed in a mold to create a desired configuration. The component is easily removed from the mold because a release agent is placed between the mold and polymer. These agents, lubricants, plasticizers, and flame retardants negatively affect the bonding ability of the polymer. In the present invention, PEEK and other thermoplastics are free of these substances.

In addition to avoiding release agents, pigments, and moisture, the bonding of thermoplastic materials may be further enhanced by adding minute metallic material to the polymer. The metallic material may be metal flakes or metal dust. Examples of such metal include iron particles, chromium, cobalt, or other suitable metals. The metal may be embedded within the polymeric material to enhance the thermal properties. Alternatively, or in addition, the metal may be applied to the bonding surfaces of the polymeric material. Energy applied to the polymer would heat both the polymeric and metallic material providing a faster and more uniform weld. It is contemplated that glass fillers, carbon fillers, talc, or combination thereof may also be used in addition to or in lieu of the metallic material.

Other factors affecting the welding of thermoplastics include size, thickness, surface geometry, material properties of the thermoplastic, and the type of host tissue involved in the weld, i.e. soft, hard, dry, wet, or moist tissue. These and other factors are explained in more detail with reference toFIG. 5.

Furthermore, how the thermoplastic is welded is an important characteristic of obtaining a robust thermal bond. The type of energy used is one way to control the welding process. As previously mentioned, various energy sources may be used to weld polymers. In an exemplary embodiment and as used primarily throughout the invention, ultrasound energy is used to create vibrations within the polymeric material thereby exciting and heating the molecules to transition to a tacky state. Two or more different types of energy may also be used. For example, ultrasound may be used to weld a polymeric component to another component, while resistive heating may be used to contour the surface or change the geometry of the materials. The surface of the component may be smoothed out or sculpted using resistive heating.

The amount of power or watts used affects the weld. Therefore, the watts may be controlled by the operator depending on the component to be welded. A switch or dial may be placed in connection with the energy source to vary the amount of current supplied to the instrument. In an exemplary embodiment, the ultrasound power may be varied, for example, between 80 and 100 watts. The amount of time the energy is applied affects the weld as well. The time may be varied from milliseconds to hundredths of seconds to actual seconds depending on the desired weld. Controlling the time controls the amount and the degree of thermoplastic material which softens and becomes tacky. In an exemplary embodiment, energy may be applied from 0.1 seconds to 3 seconds, such as approximately 0.3 seconds. In case of RF and ultrasonic energy, the wavelength of the energy may be varied to affect the softening or melting of the thermoplastic. It is also contemplated that the amount of time that energy is applied may be controlled not only by the operator but also via radiofrequency, optical, radiowave, etc. A computer or other microprocessor may send signals to the energy emitter to turn the energy on and off. The energy may be pulsed (time, power, frequency, pressure, etc. may be pulsed) to enhance bonding and avoid tissue necrosis. That is, the energy may be emitted, then relaxed, then emitted, etc.

Controlling the pressure applied to the thermoplastic material also affects the welding process. During welding, a handpiece, an anvil, a horn, end effector, or combinations thereof may be used to apply controlled force against the polymer. After welding while the polymer is cooling, the force may continue to be applied to ensure proper bonding of the materials. The handpiece, anvil, horn, and end effector may be made of aluminum, titanium, or other suitable material. Also, the pressure may be varied, increased or decreased, during the welding process. In an exemplary embodiment, the pressure may be applied by the operator or may be applied with a spring. A sensor, spring, and/or piezoelectric device may be used to monitor and control the amount of pressure applied. In another exemplary embodiment, the welding horn may apply ultrasound energy and pressure to a polymeric implant being attached to bone. The bone may act as the anvil eliminating the need for an anvil instrument. Also, a hard implant or another polymeric material may function as the anvil.

Furthermore, the placement of the energy source on the thermoplastic affects the weld. The energy may be applied to one side of the polymer, through the center of the polymer, to two or more sides of the polymer, or to generally the outer surface of the polymer.

Controlling collapse is another factor in achieving an effective thermoplastic weld. A measurement of the change of the material being welded may be made to determine when bonding is complete. Also, by using a linear variable displacement transducer (LVDT), the control system can monitor the weld more precisely. Because a LVDT translates position to voltage, the weld profile can be dynamically controlled. For example, the initial energy delivered can be a higher wattage, then when the material starts to collapse the amplitude of the wave can be decreased. By being able to monitor the position of the collapse, different weld profiles can be programmed into the system. In addition, to control how far the material collapses on the anchor during a weld, a combination of weld current and time preset in the generator control system could be used. This can also be coupled with a defined force applied during the weld. Furthermore, collapse may be controlled or monitored through the use of a mechanical stop on the fixation device itself or on the welding instrumentation. The mechanical stop would prevent collapse after a predetermined point. It is also contemplated that the collapse could be monitored by other methods such as optics, laser, or even a hall-effect sensor.

All of the above-mentioned welding parameters may be monitored and controlled by a computer. Feedback may be provided by the computer to vary, start, and stop the various parameters of welding. The feedback and control of the computer may be programmed based on the type of polymer being welded and the type of material the polymer is being welded to. For example, for PEEK to PEEK welds, the computer applies a set of parameters (time, power, pressure, frequency, wavelength, etc.) to achieve an effective weld. For other polymers or for dissimilar material, the computer parameters may be changed.

Any known energy emitting instrument may be used with the surgical welding system of the present invention. The instrument may produce energy such as resistive heating, radiofrequency, ultrasound (vibratory), microwave, laser, electromagnetic, electro shockwave therapy, plasma energy (hot or cold), and other suitable energy.FIG. 1illustrates an exemplary welding instrument of the present invention. The instrument100is an ultrasonic handpiece with a sheath102to cover and protect the end effector104and hold a fastener. The sheath102has a small counter bore at its tip to cover a portion of the cap. There is also a bushing at a nodal point of the ultrasonic signal to prevent the end effector104from contacting the sheath102. The tip of the end effector104has a small post106sticking out of the welding face which presses into a bore in the cap of the fastener. This can help align the fastener post into the anchor bore and keep the cap tight against the end effector face. After welding, the end effector104easily pulls off.

The post106on the end effector104may be threaded or have a Morse taper to mate with the cap. Alternatively, the end effector104has a bore that the top of the cap mates into. The mating of the components could also be by threads or a Morse taper along with a straight post. Furthermore, the post could be roughened on the outside surface for better adhesion.

Another exemplary instrument is illustrated inFIGS. 2A and 2B. A small cartridge heater110may be used to deliver thermal energy. The heater110may be a SUNROD ⅛ inch cartridge heater. To prevent heat build up of the outside shaft112, an air barrier114may be formed between the welding horn116and the shaft112. InFIG. 2A, four set screws118are used to create the air barrier, while inFIG. 2B, a single set screw118is used.

Referring toFIGS. 3A-3K, energy emitting instruments include various horn or end effector configurations. InFIG. 3A, the horn120A emits energy to the top surface of the implant as well as the central core via an elongate extension122A. The horn120B ofFIG. 3Bis recessed to hold the thermoplastic implant during welding. InFIG. 3C, the horn120C is concave to provide a rounded surface to the implant after welding. The horn120D ofFIG. 3Dis concave and includes a central extension122D to deliver energy throughout the implant. InFIG. 3E, the horn120E includes a spike124E which is disposable within an implant. The horn120F ofFIG. 3Fincludes a threaded pin126F which is received by a bore in the implant. InFIG. 3G, the horn120G includes dual spikes124G. The distal portion of the horn120H ofFIG. 3His dimensioned to fit within the thermoplastic implant. InFIG. 3I, a sleeve128I is disposed about the horn120I and implant. The side-weld horn120J is shown inFIG. 3J. InFIG. 3K, a dual horn welder120K is used to simultaneously weld two fasteners130.

InFIGS. 4A-4C, a welding instrument140is shown which includes three different horn or end effector configurations in one design. The instrument140includes a bonding-surface horn, a welding horn, and a contouring horn.FIG. 4Ashows the instrument140in the bonding-surface horn configuration. The center shaft142is extended distally from the instrument140, and the outer shaft144which slides over the center shaft142is also extended distally. InFIG. 4Bthe outer shaft144has been retracted into the welding instrument, leaving only the center shaft142extended. In this position, the instrument140is in the welding horn configuration. Finally,FIG. 4Cshows both the center and outer shafts142and144retracted into the instrument. The sheath146which surrounds the instrument140has also been retracted. In this position, the instrument140is in the contouring horn configuration. The distal surface148of the contouring horn may be used to reshape a thermoplastic implant, such as the head of a fastener.

In use, the instrument ofFIGS. 4A-4Cmay be reconfigured quickly by the operator during a welding operation. In the bonding-surface configuration, the instrument is positioned such that the distal portion of the extended center and outer shafts come in contact with a thermoplastic component or implant. Energy, such as ultrasonic energy, is emitted from the center and outer shafts to create a roughened surface on the implant, to create an indentation or blind hole in the implant, or to create a through hole in the implant. The type of fixation desired and the intended fastener to be used will determine how deep the bonding-surface horn should be moved into the implant. With the bonding surface formed, the outer shaft is retracted into the instrument. The distal portion of a fastener is placed in or on the bonding surface of the implant, and the end effector is placed on the fastener with the center shaft extending into a bore in the fastener. Using the desired welding parameters, the operator emits ultrasonic energy from the end effector to bond the fastener to the implant. Once welded, the fastener may be contoured or reshaped or resized with the contouring-horn of the instrument by retracting the center shaft and optionally retracting the sheath around the instrument.

As previously mentioned, monitoring and controlling the welding parameters ensures proper bonding of thermoplastics.FIG. 5illustrates the various parameters that may be monitored and controlled for the trauma welding system of the present invention. The parameters include, but are not limited to, the type of energy to emit, type of thermoplastic material, the size and configuration of the implant, the thickness of the implant, implant surface geometry, the aqueous environment, weld time, weld power, frequency and wavelength of the energy, amount of pressure applied to the implant during and after welding, the geometry of the weld horn, the impedance of the welding horn, the density of the implant, the amount of collapse of the thermoplastic material, the depth into tissue the implant is to be inserted, and the type and amount of any therapeutic agent that may be delivered.

FIG. 6shows a manual welding control box150. A surgeon determines the optimum welding parameters and enters them into the control box150prior to welding. InFIG. 7, an automatic control box152includes pre-set weld parameters. For example, preset1may be for implant A which has a known material, size, etc. to be welded in a dry environment. Preset2may be for implant A in a moist environment. Preset3may be for implant A in a wet environment. Preset4may be for implant B using energy source X. Preset5may be for implant C using energy source Y. Preset6may be implant D using energy source Z. It is contemplated that any combination of weld parameters may be pre-set into the control box.

The control box154ofFIG. 8is automatic. A sensor on the end effecter156determines the weld parameters when the horn is placed adjacent the thermoplastic material. The sensor156picks up material type, humidity of the environment, and any other parameter, then sends the data to the control box. The control box154automatically selects the energy source, time, wattage, and any other parameters.

The exemplary energy control units previously described may be used to select and vary any of the welding parameters. For example, the power or wattage of the welding horn may be varied over time. During a first period of welding, a large amount of energy may be delivered to overcome heat sink. In the second period, the energy may be reduced. In a subsequent period, the energy may be maintained at an appropriate level to thermal weld an implant.

To ensure a properly executed weld, the welding instrument of the present invention provides a positive feedback system. One way to provide user feedback is by measuring and controlling the impedance (resistance) of the end effector or weld horn. This feedback system is based on the fact that the load placed on the end effector affects the impedance of the system. That is, the pressure put on the end effector by the object to be welded changes the resistance of the end effector. To determine the handpiece or end effector impedance, the drive voltage and current through the end effector may be monitored during the weld. By using Ohm's Law V=IR, the impedance, R, may be calculated from the voltage, V, and current, I.

FIG. 9illustrates one method of ensuring a consistent weld. By first transmitting a low power ultrasonic signal through the end effector, the impedance of the handpiece can be measured with no pressure. This establishes a baseline impedance for the end effector. Then, the end effector may be subjected to known pressures, and the voltage and current may be measured to calculate the impedance for each pressure. Therefore, when a surgeon or other operator applies pressure from the end effector to a thermoplastic implant to be welded, the actual amount of pressure is fed back to the operator because the pressure corresponds to a known impedance. The surgeon may increase or decrease the pressure on the end effector until the desired pressure is achieved. With the correct pressure applied, the surgeon may activate the handpiece and emit ultrasonic energy in accordance with the calculated weld profile.

In another exemplary embodiment for providing positive feedback, the pressure and impedance of the end effector may be monitored throughout the weld profile. In the previously described method, the proper pressure based on impedance was achieved by the surgeon using a low power signal, and then the ultrasonic energy was emitted from welding. In this method, the pressure and impedance is measured during the weld. When pressure on the end effector is applied and the weld is started, for example by a hand control or footswitch, the current may be measured and the impedance calculated by a microprocessor. When the impedance is too high or too low or outside an acceptable range indicating an incorrect applied pressure, the microprocessor may send an audible or visual signal to the surgeon. Alternatively, or in addition to the signal, the microprocessor can stop energy emission until the correct pressure and impedance is achieved, then the welding may be resumed either automatically by the microprocessor or manually by the surgeon.

ReferringFIG. 10, because the drive signal is sinusoidal, Vmonitorand Vcurrentmust be sampled at a rate that is at least twice the frequency of the ultrasonic waveform. For example, if the waveform is a 41 kHz sinusoid, then samples may be taken at 328 kHz, or one sample every 3 μs. In this example, solving for the impedance, the handpiece would be 500Ω.

Also, by monitoring handpiece impedance, changes to the weld environment, such as moisture, ambient temperature, aqueous conditions, etc., may be automatically compensated for by adjusting the drive waveform of the ultrasonic energy. For example, if for a certain material it is determined that 80 W of power is required for a 400 ms period to achieve a consistent weld, then the waveform can be adjusted do ensure that this amount of energy is constantly delivered. Power is calculated using P=IV, but because the signal from the waveform is sinusoidal, the root mean square (RMS) voltage as V=(1/√2)A must be used.

As the impedance, R, of the handpiece changes, the total power delivered also changes. By increasing or decreasing the drive voltage to compensate for the change in the impedance, a constant power can be delivered.

In another exemplary method, seat collapse may be monitored by SONAR. Seat collapse is the distance a thermoplastic fastener or implant shrinks in height when ultrasonic energy is applied. Generally, thermoplastic fasteners may shrink about 20 percent in height and increase 30 percent in width when welded. For fasteners having two pieces, such as a cap and an anchor, the attenuation of the reflected ultrasonic waves changes as the two piece fastener becomes one piece. This change in attenuation may be monitored to alert the surgeon or operator when the weld is complete. Furthermore, an ultrasonic transducer could be used in conjunction with the end effector to detect the change in acoustic impedance/attenuation of the weld site. This signal may be monitored by a microprocessor/controller or data signal processor (DSP) and data may be automatically interpreted to indicate whether the weld was successful.

Another way of providing feedback of an effective weld is to monitor the Eddy currents created by the movement of the end effector. As the end effector vibrates, the linear motion creates a change in the magnetic field. By monitoring the travel of the end effector, the amount of collapse can be determined.

It is also contemplated that the material being welded may be translucent or transparent, and a visual indicator within the material could indicate when the weld is complete. For example, a pigment, dye, or other substance may be impregnated into the thermoplastic which when subjected to ultrasonic energy the pigment or dye would be released indicating that the weld is complete. Alternatively, the material of the thermoplastic may have the characteristic of changing color as heat, vibrations, or ultrasonic energy is applied for a predetermined time and a predetermined frequency and wattage.

The previously described methods for providing positive feedback to the weld operator included the use of measurements and/or computers. Another positive feedback system is provided which relies on physical force. When two objects are fastened to each other, it is common for the technician or mechanic to pull or tug on the assembly to ensure the parts are securely fastened. This common technique may apply to the thermoplastic welding system of the present invention. Once a fastener or other implant is ultrasonically welded, the surgeon can apply a quick tug on the assembly to verify the weld was completed as intended.

FIGS. 11A and 11Billustrate a feedback instrument160for performing such a physical positive feedback check. An end effector162includes a post164which emits ultrasonic energy. A thermoplastic fastener166is placed on the end effector162with the post164in a bore168of the fastener166. After emitting ultrasonic energy and welding the fastener to an implant or tissue, the surgeon actuates a biasing prong or prongs170from the post164of the end effector while the post164is still in the fastener166. In a stored configuration, the prongs170are positioned within the post164. In a deployed configuration, the prongs170extend radially from the post164by the activation of a handle, switch, or button. The extended prongs170dig slightly into the material of the fastener166so that the surgeon may now pull or tug on the instrument160proximally to verify that the fastener166is securely welded in place. Additionally, the prongs and/or post may include a strain gauge or other force measuring device to measure and display to the surgeon how many pounds of pull strength is being put on the fastener.

Some exemplary fasteners of the present invention are illustrated inFIGS. 12A-12F. The fastener180A ofFIG. 12Ais made entirely of a thermoplastic material such as PEEK. InFIG. 12B, the fastener180B includes one type of thermoplastic material in the lid182and a different type of thermoplastic material in the post184. Each material may have different welding properties.FIG. 12Cshows a fastener180C with only a proximal portion186made of PEEK, whileFIG. 12Dillustrates a fastener180D with only a distal portion188made of PEEK. InFIG. 12E, the fastener180E includes a rigid metallic core190which is enclosed by a thermoplastic192. The fastener180F ofFIG. 12Fhas a polymeric core194surrounded by PEEK196. Although not illustrated in these examples, the fasteners may include a central bore for receiving the post of the end effector.

FIGS. 13A and 13Bshow a bone plate or rod200for use with the trauma welding system of the present invention. Plate or rod200may be free of holes or may include pre-drilled thru-holes202or edge-holes204for positioning fasteners therethrough. The holes may be formed by the manufacturer at the factory or by the surgeon in the operating room. The plate or rod200may include a roughened surface206in some areas or over the entire surface. The roughened areas206provide a bonding region for fasteners or other thermoplastic implants. Additionally, the plate200may include blind holes208for securing a fastener therein. The blind hole208is an indentation in the surface of the plate200which extends only partially into the plate200. The thru-hole, roughened area, and blind hole are bonding regions. InFIG. 13B, a thermoplastic fastener210is positioned in an edge-hole204of the plate200. The distal end of the fastener210may be seated in another implant or tissue, such as bone. Because the plate includes the edge-hole, the fastener may be first at least partially implanted, then the edge-hole of the plate may be positioned around the fastener. Once properly aligned, the plate200and fastener210may be welded together and the proximal end or head212of the fastener210may be contoured as desired.

In addition to the fasteners described inFIGS. 12A-12F, other fastener configurations are illustratedFIGS. 14A-14D. InFIG. 14A, the fastener220A includes a mechanical locking mechanism in addition to thermal bonding. The fastener220A includes thermoplastic material and includes helical threads222disposed on the outer surface thereof. InFIG. 14B, the fastener220B includes longitudinally extending edges224. These edges224may function as energy directors to focus the ultrasonic energy along the edges providing a secure bond to tissue or an implant.FIG. 14Cillustrates a wedge shaped or Morse taper fastener220C. The fastener220D ofFIG. 14Dincludes an angled shoulder226which may be seated against an implant or tissue and thermally bonded in place.

The combination of thermoplastic material and ultrasonic energy of the present invention is advantageous for modifying and preparing implants while the implants are in the body. InFIG. 15A, a plate230may be positioned against bone to stabilize a fractured bone or damaged vertebrae. With the plate in place, a notch or nest232may be cut using heat energy or other mechanical means such as a drill or saw. The notches232are dimensioned and configured to receive a rod234or fastener. Therefore, implanting and thermally bonding a rod in the notch232creates a desired geometric shape with the plate230and rod234extending generally perpendicular to each other. In this configuration, the assembly may be used to stabilize the spinal column or may function as a combination internal-external fracture bone stabilizer. In the latter case, a first plate may be positioned against the fractured bone, while an exterior plate may be bonded to one or more rods extending from the notches of the first plate. The first plate provides internal fixation, and the exterior plate provides external fixation. The rods bonded between the two plates function as pins passing through the skin and other soft tissue. To further secure a rod within the notch of the plate, a fastener236may be inserted as shown inFIG. 15B. The plate230, rod234, and fastener236are thermally welded at several bonding regions238.

The thermoplastic fasteners of the present invention may also be expandable.FIGS. 16A and 16Billustrate one embodiment of a fastener240which includes a cap242and an expandable anchor244. The anchor244is generally V-shaped or conical, convex shaped. The anchor244may include a tissue-piercing distal tip246to penetrate into and through tissue and implants, such as plates or rods. As seen inFIG. 16A, the anchor244includes a bore248that tapers down from the proximal end to the distal end. The bore248is dimensioned and configured to expand when receiving the post250of the cap242. Therefore, the post250tapers from the proximal end or head down to the distal tip. The distal tip of the post250may also include a tissue-piercing end. In an exemplary method of use, the expandable anchor244is inserted through a layer of tissue252. A plate or other implant254(or other tissue) is placed adjacent the tissue252. The post250of the cap242is moved distally through the plate254and tissue252and into the bore248of the anchor244causing the anchor to expand outwardly or radially, as shown inFIG. 16B. With the head256of the cap242pressing the plate254against the tissue252, the cap242is ultrasonically welded to the anchor244. The anchor is prevented from being removed from the tissue because the expanded wall portions of the anchor contact the underside of the tissue.

FIGS. 17A and 17Billustrate another expandable fastener260embodiment. The principle of insertion and expansion are similar to the fastener ofFIGS. 16A and 16B. However, in this embodiment, the anchor262is generally cylindrical in shape. The anchor262has a cylindrical bore therein. The cap264includes a post266which is generally cylindrical and has a widened portion disposed between a proximal portion and a distal portion. The diameter of the distal portion of the post266is configured for initial insertion in the bore268of the expandable anchor262. The diameter of the widened portion is configured such that it expands the walls of the anchor262radially outward as the cap264is moved distally into the anchor262. In a seated configuration, the cap264is ultrasonically welded to the anchor262and the head270of the cap264holds a plate or tissue272against lower tissue274. The expanded walls of the anchor contact the lower tissue preventing the fastener from being pulled out.

Referring toFIGS. 18A and 18B, the fastener280includes a cap282and an anchor284which is configured as a tubular mesh. The tubular mesh284has an unexpanded diameter and an expanded diameter. The post286of the cap282is dimensioned to fit within the lumen of the tubular mesh284to expand the mesh to its expanded diameter. The post286may include ridges or ring-like structures288disposed thereon to aid in the expansion of the tubular mesh anchor284. In an exemplary method of use, the anchor284, in its unexpanded diameter, is positioned in tissue290. A hole292may be drilled into the tissue290for receiving the anchor284if desired. A bone plate or other implant294is placed adjacent the bone290. The cap282is moved through the plate294and tissue290and into the lumen of the mesh284.

The mesh achieves its expanded diameter in at least one of two ways. First, the insertion of the post (with ridges) into the mesh causes the mesh to expand thereby preventing the anchor from pulling out of the tissue. Alternatively, the post with or without ridges may be inserted into the lumen of the mesh while the mesh maintains its unexpanded diameter. Ultrasonic energy and pressure from the welding horn may be applied to the cap causing it to swell thereby locking the anchor into the tissue. It is also contemplated that a combination of expansion methods may be used. That is, the post with ridges may be inserted into the lumen of the mesh causing the anchor to expand. Then, ultrasonic energy may be applied to the fastener to further expand the mesh and bond the cap to the anchor.

Another embodiment of an expandable fastener300is illustrated inFIGS. 19A and 19B. A top or bottom view of the anchor302is shown inFIG. 19A. The anchor302includes two or more arced members or longitudinal portions of a tube304. When placed together as inFIG. 19A, the anchor302is in an unexpanded configuration. The cap306includes a post308and lid310. To fasten a bone plate or other implant312to tissue314, the anchor302in its unexpanded configuration is inserted into the tissue314. The post308, which may include a tissue-piercing point, is inserted through the plate and tissue. As the post308enters the anchor302, the arced members304are moved outwardly or radially. This is possible because the inner bore diameter of the anchor302in its unexpanded configuration is smaller than the diameter of the post308of the cap306. Once the cap306is pressed into the anchor302, it is ultrasonically welded to the anchor302. The anchor and fastener are prevented from being pulled out of the tissue because the proximal ends of the expanded arced members of the anchor contact the tissue. The lid of the cap holds the bone plate firmly against the tissue.

The trauma welding system of the present invention also provides fasteners configured as triangulation staples. Examples of these staples are illustrated inFIGS. 20A-20E. InFIG. 20A, the staple320A includes first and second nails or braids322A. The nails322A include a long post and a head disposed on the proximal end of the post. The head may be slanted, angled, or pivotable to allow the head to seat flush against an implant or tissue. The distal end of the post includes a tissue-piercing tip328A. The nails322A may include a central bore configured for receiving an end effector. As shown, the fastener320A includes two nails; however, it is contemplated that the triangulation staples of the present invention may include three or more nails. The staple320A ofFIG. 20Ais shown holding two bone plates or other implants330A and332A against each other at their edges. The first nail322A is inserted through the first plate330A near the edge of the first plate. The first nail322A is angled generally between 30 and 60 degrees with respect to vertical. A second nail322A is inserted through the second plate332A near the edge of the second plate. The second nail322A is also angled such that the distal tips328A of the first and second nails contact each other. Ultrasonic energy is applied to the nails322A to bond the distal tips328A together to form a bonding area334A. The nails322A may also be welded to the plates330A and332A where the nails passed through the plates. Additionally, the edges of the bone plates may be ultrasonically welded together. When implanted, the staple320A securely holds the two plates330A and332A together and fastens the plates to tissue, such as bone.

InFIG. 20B, the triangulation staple320B includes two nails322B with a suture or cable324B connected with the heads of the nails. In an exemplary use of this staple configuration, an implant330B is positioned adjacent another implant or tissue332B. The first nail322B of the staple is inserted into the tissue332B on one side of the implant330B. The second nail322B is inserted into the tissue332B on another side of the implant330B. The cable324B, spanning between the nails, contacts the implant330B. As the nails322B are driven further into the tissue332B, the cable324B tensions and presses the implant330B against the tissue332B. Also, with the nails firmly implanted in the tissue, the distal tips328B of the nails322B contact each other. Ultrasonic energy may be used to weld the distal tips328B together to form a bonded region.

The triangulation staple320C ofFIG. 20Cis a one-piece design. The first and second nails322C are connected to each other by a cross member326C attached at the proximal ends of the nails. The nails322C may be rotatable or pivotable from their connection with the cross member326C. The distal ends of the nails may include tissue-piercing tips328C. In a pre-implantation configuration, the nails322C extend generally perpendicular to the cross member326C. In use, the staple320C is inserted through tissue, an implant, or both. The staple is inserted with the nails322C being generally perpendicular to the cross member. Once positioned, the nails322C may be pivoted such that the distal tips of the nails contact each other. The rotation of the nails322C may be performed by an instrument designed to angle the nails, for example by using the central bore therein. With the tips in contact, the nails322C may be ultrasonically welded together to form a secure fixation of the implant and/or tissue.

InFIGS. 20D and 20Ethe staple320D includes a cross member326D which has channels for allowing the nails322D to slide therein. The channels have a central axis which intersect below the cross member326D such that when the nails322D are moved distally through the channels, the distal tips328D of the nails connect each other, similar to the previously described embodiments. As seen inFIG. 21E, the cross member326D includes one thru-channel338D and one edge-channel340D. This configuration allows the nails322D to be inserted sequentially (not at the same time, if desired). In an exemplary method of use, the first nail322D is partially positioned in the implant (or tissue) to be fastened. The first nail322D is angled relative to vertical at an angle generally equal to angles of the channels of the cross member326D. Then, the edge-hole340D of the cross member326D is positioned around the first nail322D. The second nail322D is inserted into the thru-hole338D of the cross member326D, and both nails322D are fully inserted into the implant/tissue. The distal tips328D of the nails322D may be ultrasonically welded together, and the nails322D may be ultrasonically welded to the cross member326D.

An exemplary staple welding horn350is shown inFIG. 21. The horn350includes two elongate horn shafts352disposed in channels in a horn base354. The horn shafts352may be slideable within the channels. Both the horn shafts352and the horn base354may emit ultrasonic energy for welding the thermoplastic material, such as PEEK, of the above described staples. In use, the horn shafts352are retracted proximally. The horn350is placed over the staple such that the horn shafts352align with the central bore in the nails. It should be noted that the nails of the staples previously described may include longitudinally extending bores not only to receive the ultrasonic horn but also to receive an instrument for positioned the nails in implant and/or tissue. With the horn350properly aligned, the horn shafts352may be distally extended into the channels of the nails. Ultrasonic energy and a desired weld profile may be used to thermally bond the staple.

Referring now toFIGS. 22A and 22B, a thermoplastic removal instrument360is shown. The instrument360includes an ultrasonic welding horn shaft362. The distal portion of the shaft362is generally conical and tapers inward toward the distal tip. An elongate pin364extends from the distal tip. The distal portion of the shaft362includes helical threads366disposed on the outer surface thereof. It is contemplated that besides having helical threads, the distal portion of the shaft may include any engagement means such as barbs, prongs, or other similar configurations. To remove a thermoplastic component, the elongate pin364of the instrument360is inserted into a channel of the component. The channel may already exist in the component or may need to be created with a drill and bit. With the pin364in the channel, the instrument360is moved further distally until the distal portion of the shaft362contacts the component. The distal portion is then threaded into the component with the helical threads366. Ultrasonic energy is emitted from the pin364to soften the thermoplastic material of the component. As the material is softened, the instrument360is pulled proximally, and the distal portion of the shaft362begins to pull the component out. The softened thermoplastic material adjacent the pin364is inherently reshaped as the component is pulled from the implant/tissue.

InFIGS. 22A and 22B, a PEEK fastener368is holding a bone plate370to bone372. The fastener368may be removed from the bone372with the method just described. InFIG. 22A, with the fastener368in place, the distal portion of the fastener368is thick thereby locking the fastener368in the bone372. InFIG. 22B, as the fastener368is pulled proximally, the distal portion thins or narrows as it is pulled from the bone372and plate370. Because the fastener368is only softened and not liquefied, the removal instrument360is able to remove substantially all, if not entirely all, of the thermoplastic material from the bone372.

FIGS. 23A-23Dillustrate a method of stabilizing a fracture bone with the devices of the present invention. InFIG. 23Aa femur380is shown with a fracture382. An intramedullary rod384may be placed within the medullary canal of the femur380, as seen inFIG. 23B. The rod384may be made of thermoplastic material, such as PEEK. The rod384is positioned in the bone such that it spans the fracture on each side. InFIG. 23C, a plurality of channels are created in the femur380. The channels are dimensioned to receive a fastener of the present invention. A first channel386is created in cortical bone of the femur380. The first channel386creates a passage from the exterior of the femur to the IM rod384. A second channel388is created in the cortical bone and slightly into the IM rod384. The second channel388forms an indentation or nest in the rod384. A third channel390is formed entirely through the femur380and IM rod384. The third channel390is a thru-hole which extends through the cortex (both cortical sides) of the femur380. A fourth channel392is created in cortical bone and partially into the IM rod384. The fourth channel392forms a blind-hole in the rod384. The channels may be formed by any means known to surgeons, such as by a drill and bit, a guidewire, a reamer, or other similar instrument. It is contemplated that any number of channels and any combination of channel types may be created in the bone and IM rod.

InFIG. 23Dfasteners are positioned in the channels and ultrasonically welded in place. Before a first fastener394is placed in the first channel386, the surface of the IM rod384exposed by the channel requires preparation for bonding. The surface may be roughened in situ using any suitable instrument. Alternatively, the surface may be roughened by the manufacture or the surgeon before implantation in the bone. With the bonding surface prepared, the first fastener394in placed in the first channel386such that the distal end of the fastener394contacts the bonding surface of the rod384. Ultrasonic energy is applied to the fastener to thermally bond the first fastener394with the IM rod and femur. A second fastener396is placed in the second channel388with the distal end of the second fastener396positioned in the indentation in the rod384. The second fastener396may then be ultrasonically welded to the rod and femur. A third fastener398is placed in the thru-hole of the third channel390. The leading end of the third fastener398is configured for insertion through the channel, while the trailing end of the fastener may include a cap or head. The third fastener398is ultrasonically welded to the IM rod and femur. The leading end of the third fastener398may be contoured or flattened to form a leading end head. A fourth fastener400is placed in the fourth channel392and within the blind hole in the rod. The fourth fastener400is thermally welded, and the cap or head is contoured to conform to the outer surface of the femur. It is contemplated that the three-horn instrument ofFIGS. 4A-4Cmay be used to create the bonding regions, to weld the fasteners, and to contour the thermoplastic implants.

Referring now toFIGS. 24A and 24B, the devices and methods of the present invention are used to repair an end portion of a bone410having a plurality of fractures412. Like the repair of the fractured femur ofFIGS. 23A-23D, a PEEK intramedullary rod414is placed in the medullary canal of the bone410. A plurality of channels is created through the end portion of the bone410and into the IM rod414. Any channel type previously described may be used in this method. A plurality of thermoplastic fasteners416are placed in the channels and are ultrasonically welded to the rod414. Multiple (three or more) fasteners416may be welded to the end portion of the IM rod414without reducing the strength of the rod. Since the fasteners and rod are made of PEEK, the thermally bonded fasteners within the rod enhance the strength of the rod. Therefore, many fasteners may be bonded with the rod without losing structural support from the channels created in the rod.

Another method and apparatus for repairing a fractured bone is illustrated inFIGS. 25A and 25B. Instead of an intramedullary rod being placed in the bone canal, a bone plate420is positioned against the fractured femur422on the exterior side of the bone. The bone plate420is made of thermoplastic material such as PEEK. A first channel424is created through the plate420and through the bone422to form a thru-hole. A second channel426is drilled through the bone plate420, across the fracture428, and through the bone422. A third channel430is formed through the plate420and partially into the femur422. Additional channels may be created as desired. InFIG. 25B, PEEK fasteners432are placed in the channels and ultrasonically welded to the femur422and bone plate420. The fastener type and method of welding each fastener may be similar to previously described embodiments.

FIGS. 26A and 26Bshow a combination configuration for repairing a fractured bone. The combination includes an IM rod440positioned in the medullary canal of the bone442and a bone plate444positioned against the exterior surface of the bone442. The rod and plate may be made of PEEK. InFIG. 26A, a plurality of channels446are created through the plate, bone, and/or rod. PEEK fasteners, shown inFIG. 26B, are positioned in the channels446and ultrasonically welded to the plate, bone, and rod. A first fastener448is welded to a bonding region450on the surface of the rod440. A second fastener452is welded in an indentation in the rod440. A third fastener454extends through the plate, bone, and rod. The third fastener454includes a mushroomed or contoured head on its distal end, and on the proximal end, no head is needed since the fastener bonds directly to the bone plate444. A fourth fastener456is positioned in a blind hole in the rod440. The fourth fastener456is also free of a proximal head or cap. As seen inFIG. 26B, the bone plate444is contoured to conform to the exterior surface of the femur442. This may be performed with ultrasonic energy, resistive heating, or other suitable energy source.

An exemplary bone plate460of the present invention is shown inFIGS. 27A-27C. Some previously described bone plates and IM rods included no pre-fabricated holes. Instead, the surgeon formed channels in the plates and rods to insert fasteners. In the embodiment ofFIG. 27A, the bone plate460includes a plurality of openings. Some openings are threaded while others are free of treads.FIG. 27Bis a cross sectional view of a threaded opening462of the plate460.FIG. 27Cis a cross sectional view of an unthreaded opening464. The plate460is made of thermoplastic material such as PEEK.

Shown inFIGS. 28A-28Dare exemplary fasteners for affixing the bone plate to a bone. The fasteners are made of PEEK and may include a central channel configured for receiving a welding horn.FIG. 28Ashows a PEEK fastener470A having a threaded head472A and a threaded shaft474A. The threaded head472A is dimensioned to be threaded into one of the threaded openings462of the bone plate460. The thread shaft474A is configured for insertion in tissue.FIG. 28Bshows a fastener470B with a smooth, unthreaded head476B and a threaded shaft474B. The unthreaded head476B is configured for insertion in one of the unthreaded openings464of the bone plate460.FIG. 28Cshows a fastener470C having a threaded head472C and smooth shaft478C.FIG. 28Dshows a fastener470D with a smooth head476D and smooth shaft478D. In use, the bone plate is positioned on a fractured bone. Fasteners ofFIGS. 28A-28Dare positioned through the openings in the plate and into the bone. The fasteners are ultrasonically welded to the plate and bone. The smooth head or smooth shaft of a fastener is thermally bonded to the plate or tissue, while the threaded head or threaded shaft is mechanically secured and thermally bonded to the plate and/or tissue.

The trauma welding system also provides for the modular assembly of implants intracorporeally. InFIG. 29, spinal cages480include thermoplastic material which may be welded to vertebral body replacement components482. The use of ultrasonic energy to weld the assembly together in the body prevents damage to surrounding tissue since the vibration energy creates just enough heat to soften and make tacky the thermoplastic material.FIG. 30illustrates a modular IM rod484and a modular bone plate486. The IM rod484includes a first portion484A welded to a second portion484B at a bonding region488. The second portion484B is welded to a third portion484C at another bonding region488. In this embodiment, the smaller portions of the rod may be implanted using minimally invasive techniques. Each portion may be welded to an adjacent portion intracorporeally. The bone plate486, likewise, includes a plurality of modular portions486A,486B,486C which may be thermally bonded together in the body. It is also contemplated that the small portions of the rod, plate, or other implant may be assembled by the surgeon in the operating room prior to implantation. This way, the implant manufacture can produce small portions of an implant allowing the surgeon to select the size and number of portions to assembly to create a custom tailored implant. It is contemplated that intracorporeally sequential welding applies to other types of implants as well, such as modular stents, modular acetabular component, modular spacers, and modular wedges.

In a further embodiment of the present invention shown inFIGS. 31A and 31B, the trauma welding system may be used to stabilize joints of the spine such as intervertebral joints and facet joints. Stabilization of the spine is achieved by attaching rigid rods, plates, spacers, or wedges490between two or more vertebrae. Fasteners492, such as pedicle screws, are inserted into the vertebrae, and plates/rods490are connected to the screws492. The spinal rods, plates, fasteners, etc. may include thermoplastic material, such as PEEK. The implants may be biodegradable or biostable. InFIG. 311B, PEEK pedicle screws492are inserted into vertebral bodies using the methods described herein. PEEK stabilizing plates490span the pedicle screws492and are ultrasonically bonded with the screws. Stabilizing cross bars494are thermally welded to the stabilizing plates at bonding regions496. It is contemplated that any combination of fasteners, rods, plates, and wedges may be ultrasonically welded to stabilize joints of the spine.

InFIG. 32, a spacing fastener500is shown. The fastener500includes an anchor502and a cap504. The anchor502is generally a cylindrical shaft with a head506disposed on the proximal end of the shaft508. The shaft508may include helical threads510for mechanical locking into tissue512. The anchor502includes a bore extending along the central axis of the anchor. The fastener500further includes a cap504having a post514and a lid516attached to the proximal end of the post. The post514is dimensioned and configured for insertion into the bore of the anchor502. Both the cap and anchor may be made of thermoplastic material such as PEEK. In an exemplary method of use, the anchor502is implanted in tissue512as shown inFIG. 32. The anchor502may be mechanically and/or thermally bonded in the tissue. A bone plate or rod518is placed over the head506of the anchor502. A pre-drilled passageway520formed in the plate by the manufacturer is aligned with the bore of the anchor. Alternatively, a passageway520may be formed by the surgeon and aligned with the bore. The cap504is inserted through the passageway520of the plate518and into the bore of the anchor502. The cap, plate, and anchor may be thermally bonded together with ultrasonic energy. In the implanted configuration, the head506of the anchor502acts as a spacer between the tissue512and plate518. The spacing fastener500ofFIG. 32may be used as a pedicle screw separating a stabilizing plate from vertebral bodies.

In a further embodiment, the trauma welding system may be utilized to provide flexible stabilization of the spine, or any other joint or bone of the body. The soft tissue around and near a joint may become weakened over time, and the range of motion of the joint usually increases thereby allowing excessive tissue laxity. Also, instability of a joint may be caused by structural changes within the joint as a result of trauma, degeneration, aging, disease, or surgery. An unstable spinal joint may be rigidly stabilized as previously explained or may be dynamically stabilized to allow some range of motion of the spinal joints. Fasteners, screws, plates, rods, etc. made of PEEK may be implanted between two or more vertebrae. The plates and rods are configured and dimensioned to permit some flexing and/or bending. The amount of flexibility of these PEEK implants may be adjusted by the surgeon in the operating room using energy, such as ultrasound, resistive heating, etc. and by varying the weld parameters.

As seen inFIG. 33, a plate or rod530may be configured to lock with a fastener532in one direction, but would allow movement in another direction. For example, the plate530and fastener532permits superior and inferior motion of the spine but would prevent lateral motion. Also, the plate530and fastener532may permit motion in one plane and restrict motion in a different plane. The fasteners and plates ofFIG. 33may be made of PEEK and may be ultrasonically bonded to stabilize the spine.

FIGS. 34A and 34Billustrate another embodiment to stabilize a joint such as a joint of the spine. The swivellable pedicle screw assembly540may be used to connect a longitudinal bar542to a pedicle screw544thereby forming a spine stabilization device. The assembly540includes a body546having an upper end, a lower end, a hole548which is open at least towards the bottom and has an axis, and a through hole positioned perpendicular to the axis. The assembly540also has a collet chuck550mounted coaxially on the inside of the body546in such a way that it can slide along the axis. The collet chuck550has a through hole552which is flush with the through hole of the body546, and a chamber which faces at least downwards and is defined by tongues spring-mounted against the cylinder axis. When the collect chuck550is inserted in the body, the through holes552align to allow insertion of the longitudinal bar542. The head554of a pedicle screw544can be clicked into the chamber from below by spring-action. The assembly540allows for the pedicle screw544to be inclined within a certain range. The assembly may be made of thermoplastic material such as PEEK. Ultrasonic energy may be used to thermally bond the head554of the pedicle screw544within the chamber of the collet chuck550and to bond the longitudinal bar542with the pedicle screw544.

It is contemplated that a simple ball and socket assembly may be used to stabilize the spine as well. The ball is the head of the pedicle screw as described above. The socket includes a chamber for receiving the ball. The socket may include an attachment means, such as a thru-hole or a thermal bonding region, for receiving and affixing a plate or rod. The ball, socket and plate/rod may be ultrasonically welded together to form a spin stabilizing configuration.

FIGS. 35A and 35Billustrate a bone fixation assembly560for securing a bone plate to bone. The assembly560includes the fixation device562, a bushing564, a fastening screw566, and a locking screw568. The bushing564is seated within a through hole in the fixation device562and can rotate within the through hole and has a sidewall with a bore. The sidewall has at least one slot for allowing outward expansion of the sidewall against the through hole to thereby lock the bushing564at a selected angle relative to the axis of the through hole. The fastening screw566has a threaded shaft570for insertion through the bore of the bushing564and threads into bone to secure the bushing564and fixation device562to bone. The head of the fastening screw566fits in the bushing and includes a radial wall and open end defining a recess. The radial side wall has at least one slit for allowing outward expansion of the radial wall thereby outwardly expanding the sidewall of the bushing564. The locking screw568has a body that threads in the head of the fastening screw566to thereby outwardly expand the radial wall of the fastening screw566. The assembly components may be made of PEEK. In an alternative embodiment, a fastening member572, made of PEEK, replaces the fastening screw566and locking screw568. In this embodiment, the fastening member572is inserted through the bore of the bushing564and into the bone. The fastening member572may be ultrasonically welded to the bushing564and the bushing564may be thermally bonded to the fixation device562. The fastening member572is ultrasonically bonded to the bone using the welding methods described herein.

Referring now toFIGS. 36A and 36B, a cable tensioning fastener580is illustrated. The fastener580includes a post582and a cap584disposed on the proximal end of the post. The post582is configured for winding a suture or cable586thereon. The suture586may be attached to the post582by applying heat to PEEK material of the post, setting the suture into the softened PEEK, and allowing the PEEK to harden. Alternatively, a small channel may extend radially through the post. The suture586may be threaded through the channel. In a simple configuration, the suture586may be wrapped over itself on the post582, like a spool of string. In an exemplary method of use as shown inFIGS. 36A and 36B, the suture or cable586is placed through or around tissue588such as a rotator cuff. The suture586is attached to the post582of the fastener580as previously described. The fastener580is then rotated to coil up the suture586on the post582and draw the rotator cuff588in close to the fastener580. To secure the assembly, the fastener580is inserted into tissue such as bone590. Ultrasonic energy is applied to the fastener580to bond the fastener to the tissue590and bond the suture586to the post582of the fastener580. In this position, the rotator cuff is securely fastened to the bone.

FIG. 37illustrates another exemplary use of the cable tensioning fastener580ofFIGS. 36A and 36B. A first tensioning fastener580is positioned in a vertebral body592. A second fastener580is positioned in an adjacent vertebral body592. A cable586spans between the posts of the first and second fasteners. One or both fasteners are rotated to tension the cable, and the fasteners are implanted in the vertebrae and ultrasonically welded in place. Third and fourth fasteners are implanted in spinous processes594. A tensioned cable586is connected with the fasteners580. The embodiment ofFIG. 37provides controlled stabilization of the spine by affixing flexible or non-flexible cables between vertebrae. Flexible cables provide dynamic stabilization, while non-flexible cables provide rigid stabilization.

The present invention also provides a glenoid replacement component600A, shown inFIG. 38A. The inner side is configured for placement on the scapula602, and the outer side is configured for articulation of the head604of the humerus606. Thermoplastic fasteners608secure the component600to bone. InFIG. 38B, a glenoid replacement component600B is shown having prongs610extending from the inner side. The prongs610may be inserted into pre-drilled holes in the scapula and ultrasonically welded therein.FIG. 38Cillustrates another embodiment of a glenoid replacement component600C. The component600C includes two thru-holes612extending from the outer to the inner side of the component. PEEK fasteners may be used to secure the replacement component to bone. The caps or heads of the fasteners may be contoured and flattened so as to not interfere with the head of the humerus.

Referring now toFIG. 39, a thermoplastic cross pin620is illustrated. The pin620may be made of PEEK. The cross pin620is used to stabilize and strengthen the neck622and head624of the femur626. To implant the pin, the pin620is positioned in a channel extending into the neck622and head624. The pin620may be mechanically locked within the channel and/or may be thermally bonded within the channel. Thermoplastic fasteners628are placed through the cortical bone of the femur626and into contact with a bonding region on the pin620. As previously described, the bonding region may be a roughened surface, an indentation, a blind-hole, or a thru-hole. The fasteners628are then ultrasonically welded to the pin620and bone to secure the pin620within the femur626.FIG. 40illustrates a cross pin jig630to be used during implantation of the pin620. The jig630includes a shaft632and a series of pivoting arms634connected with the shaft632. At the end of the pivoting arms634is an insertion guide636. The guide636has a passageway638configured for guiding a fastener. The arms634pivot in one plane with respect to the shaft632such that the passageway638of the insertion guide636is always aligned with the shaft632. In use, the shaft632of the jig630is inserted into the drilled channel extending into the neck and head of the femur. The insertion guides636are positioned adjacent the surface of the bone. A drill and bit is placed in the guide636and a hole is created through the cortical bone terminating in the channel. A plurality of holes may be formed in the bone to receive a plurality of fasteners. Once the holes have been drilled, the jig630is removed and the cross pin620is inserted into the channel. Fasteners are then placed through the holes and into contact with the cross pin620. Ultrasonic welding bonds the fasteners, cross pin, and bone together. In an alternative embodiment, the shaft of the jig has a diameter which slides into a central passageway of the cross pin. In this embodiment, the cross pin may be implant in the channel, then the jig may be placed in the cross pin.

In a related invention,FIG. 41shows a tissue cauterization device640. A cut or opening642is formed in soft tissue such as skin644. To stop bleeding at the cut, ultrasonic energy may be applied to the tissue. An energy horn640, similar to those previously described, may be placed in contact with bleeding tissue644. Ultrasound energy emitted from the horn stops the flow of blood by hemostasis. InFIG. 42, ultrasound from an energy horn640is applied to gelatin648within a joint650. The gelatin648binds to the tissue and stops bleeding. Gelatin, or other suitable substance, may also be used with the tissue cauterization device ofFIG. 41.

FIG. 43illustrates a periosteal flap660used to repair a damaged bone662. The flap660is fastened to the bone662using thermoplastic fasteners664and methods previously described. Tissue grafts may also secured intracorporeally using PEEK fasteners and ultrasonic energy.

It is also contemplated that metal may be ultrasonically welded to PEEK. For example, a fastener may be made of metal. By placing the metallic fastener on the end effector of the welding instrument, the fastener functions as an extension of the end effector. Therefore, applying pressure from an ultrasound-emitting metallic fastener to a PEEK implant drives the fastener into the implant and thereby secures the fastener to the implant. It is further contemplated that a thermoplastic fastener may be bonded with a metallic implant. Accordingly, the devices and methods described throughout may utilize metallic fasteners bonded to thermoplastic implants and thermoplastic fasteners bonded to metallic implants.

In a further embodiment of the present invention, a method for securing a thermoplastic fastener670into tissue672is provided.FIGS. 44A and 44Billustrate the method. InFIG. 44A, a channel674in drilled in tissue such as bone672. The fastener670includes a post676and a lid678, similar to other fasteners disclosed herein. The diameter of the post676is greater than the diameter of the channel674in the bone672such that the fastener670does not freely slide into the channel674. InFIG. 44B, an end effector680is placed in and on the fastener670. Ultrasonic energy is emitted from the end effector680to soften the thermoplastic material of the fastener670. Simultaneously, downward pressure is applied to the end effector680and fastener670so that the softened material conforms to the smaller diameter of the channel674. The fastener670is moved distally until it is fully seated in the bone672. After energy is no longer emitted, the thermoplastic material re-hardens thereby securely bonding the fastener670to the bone672.

In another application of the present invention, thermoplastic fasteners may be used to lock a drug delivery system to an implant or to tissue. For example, a reservoir, balloon, or bladder may be placed within the body and filled with a pharmaceutical substance, gene therapy, or cell therapy. Using PEEK or other thermoplastic, the reservoir may be sealed and stabilized in the body. The contents of the reservoir may leach out or elute out from pores or openings in the reservoir material. Alternatively, the thermoplastic may be biodegradable to allow the contents to escape from the reservoir and into the body. It is contemplated that other drug delivery systems may be used with the present invention. Also, the pharmaceutical agents may include antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein (BMP), demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, germicides, fetal cells, stem cells, enzymes, proteins, hormones, cell therapy substances, gene therapy substances, bone growth inducing material, osteoinductive materials, apatite compositions with collagen, demineralized bone powder, or any agent previously listed. U.S. Provisional Patent Application No. 60/728,206 entitled “Drug Eluting Implant” discloses means for delivering therapeutic agents. The above-mentioned provisional application is incorporated by reference herein in its entirety.

The welding system of the present invention may further include the process of welding collagen similar to the way PEEK is bonded. Collagen fibers may be infused within a biodegradable polymer or gelatin to enhance welding properties. An energy source, such as ultrasonic energy, may be used to weld the collagen. As previously described the quality of weld depends upon the welding parameters of time, energy time, wattage, frequency, pulsation, pressure, etc. In an exemplary embodiment, collagen is placed in biodegradable polyglycolic acid. Once implanted, the polymer would biodegrade leaving the collagen fibers to heal surrounding tissue. Also, imbedded in the polymer may be cells, antibiotics, keratin, tissue inductive factors, or other pharmaceutical agents disclosed herein.

Alternatively, the collagen fibers may be packed very densely and may be desiccated. The fibers may be welded together or an interfacial material such as talc, glass, graphite, or protein may be added to harden the fibers to a gelatin. In an exemplary embodiment, collagen fibers may be combined with denatured porcine collagen cells. The two substances may be welded together to form a unitary implant. The implant may be fastened within the body for cell therapy, gene therapy, or for the delivery of pharmaceutical agents.

Another welding technique that may be utilized with the present invention is plasma welding. Generally, there are four states of matter in physics: solid, liquid, gas, and plasma. Plasma is a gas in which atoms have been ionized. Therefore, plasma has magnetic and electrical fields that move unpredictably, altering the environment. As the environment changes, so does the plasma. These ionized gases or plasma can be used to fuse, bone or weld material within the body. Plasma welding may be controlled similar to the way thermal welding is controlled as previously described. A plasma stream may be used for polymeric welding, protein welding, or collagen welding. When welding intracorporeally, cold plasma welding may be used to prevent tissue necrosis. Cold plasma can weld tissue, polymers, metals, ceramics, and composites to each other and to one another. Cold plasma may also be used to debride wounds in surgery, to selectively kill bacteria, to roughen the surface of tissue to make it more receptive to pharmaceutical agents, or to prepare a surface of a bone for a joint replacement component. It can also be used to shrink tissue and polymers, ablate tissue, or smooth out wrinkles for plastic surgery either on the surface of the skin or under the skin. Cold plasma welding may be performed through a cannula in a straight line or curved/deflected to reach a target site within the body. The plasma energy may be altered by accelerating electrical charges or electromagnetic fields.

In a related invention, welding of thermoplastics, tissue, implants, etc. described herein may be performed utilizing suction or negative pressure. For example, suction may be applied to a bone to pull a cartilage graft or plate to the surface of the bone. A tube may be placed within the bone to create a negative pressure. This would temporarily hold the implant and contour it to the surface while an energy source is used to weld the graft to the bone with or without traditional or thermoplastic fasteners. Also, suction may be used to stabilize an implant during welding or while an adhesive is curing. Examples of biocompatible adhesives include mollusk adhesive, protein adhesive, fibrin adhesive, cyanoacrylates, or other known adhesives.

It is contemplated the surgical welding system of the present invention may be used with and integrated with the methods and devices disclosed in U.S. Provisional Application No. 60/765,857 entitled “Surgical Fixation Device” filed on Feb. 7, 2006. In the '857 document, various thermoplastic fixation devices are disclosed. The fixation devices may be, but are not limited to, degradable, biodegradable, bioerodible, bioabsorbable, mechanically expandable, hydrophilic, bendable, deformable, malleable, riveting, threaded, toggling, barded, bubbled, laminated, coated, blocking, pneumatic, one-piece, multi-component, solid, hollow, polygon-shaped, pointed, self-introducing, and combinations thereof. Also, the devices may include, but are not limited to, metallic material, polymeric material, ceramic material, composite material, body tissue, synthetic tissue, hydrophilic material, expandable material, compressible material, heat bondable material, and combinations thereof.

The methods and devices disclosed in the '857 document may be used in conjunction with any surgical procedure of the body. The fastening and repair of tissue or an implant may be performed in connection with surgery of a joint, bone, muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, or other body parts. For example, tissue may be repaired during intervertebral disc surgery, knee surgery, hip surgery, organ transplant surgery, bariatric surgery, spinal surgery, anterior cruciate ligament (ACL) surgery, tendon-ligament surgery, rotator cuff surgery, capsule repair surgery, fractured bone surgery, pelvic fracture surgery, avulsion fragment surgery, shoulder surgery, hernia repair surgery, and surgery of an intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor tendons, etc.

It is contemplated that the devices and methods of the present invention be applied using minimally invasive incisions and techniques to fasten muscles, tendons, ligaments, bones, nerves, and blood vessels. A small incision(s) may be made adjacent the damaged tissue area to be repaired, and a tube, delivery catheter, sheath, cannula, or expandable cannula may be used to perform the methods of the present invention. U.S. Pat. No. 5,320,611 entitled “Expandable Cannula Having Longitudinal Wire and Method of Use” discloses cannulas for surgical and medical use expandable along their entire lengths. The cannulas are inserted through tissue when in an unexpanded condition and with a small diameter. The cannulas are then expanded radially outwardly to give a full-size instrument passage. Expansion of the cannulas occurs against the viscoelastic resistance of the surrounding tissue. The expandable cannulas do not require a full depth incision, or at most require only a needle-size entrance opening.

U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 also disclose cannulas for surgical and medical use expandable along their lengths. The cannula can be provided with a pointed end portion and can include wires having cores which are enclosed by jackets. The jackets are integrally formed as one piece with a sheath of the cannula. The cannula may be expanded by inserting members or by fluid pressure. An expandable chamber may be provided at the distal end of the cannula. The above mentioned patents are hereby incorporated by reference.

In addition to using a cannula with the present invention, an introducer may be utilized to position implants at a specific location within the body. U.S. Pat. No. 5,948,002 entitled “Apparatus and Method for Use in Positioning a Suture Anchor” discloses devices for controlling the placement depth of a fastener. Also, U.S. patent application Ser. No. 10/102,413 discloses methods of securing body tissue with a robotic mechanism. The above-mentioned patent and application are hereby incorporated by reference. Another introducer or cannula which may be used with the present invention is the VersaStep® System by Tyco® Healthcare.

The present invention may also be utilized with minimally invasive surgery techniques disclosed in U.S. patent application Ser. No. 10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patent documents disclose, inter alia, apparatus and methods for minimally invasive joint replacement. The femoral, tibial, and/or patellar components of a knee replacement may be fastened or locked to each other and to adjacent tissue using fixation devices disclosed herein and incorporated by reference. Furthermore, the methods and devices of the present invention may be utilized for repairing, reconstructing, augmenting, and securing tissue or implants during and “on the way out” of a knee replacement procedure. For example, the anterior cruciate ligament and other ligaments may be repaired or reconstructed; quadriceps mechanisms and other muscles may be repaired; a damaged rotator cuff may be mended. The patent documents mentioned above are hereby incorporated by reference.

Furthermore, it is contemplated that the present invention may be used with bariatric surgery, colorectal surgery, plastic surgery, gastroesophageal reflex disease (GERD) surgery, or for repairing hernias. A band, mesh, or cage of synthetic material or body tissue may be placed around an intestine or other tubular body member. The band may seal the intestine. This method may be performed over a balloon or bladder so that anastomosis is maintained. The inner diameter of the tubular body part is maintained by the balloon. The outer diameter of the body part is then closed or wrapped with a band, mesh, or patch. The inner diameter of the tubular body member may be narrowed or restricted by the band. The band may be secured to the tubular body part or surrounding tissue with the devices and methods described herein and incorporated by reference.

It is further contemplated that the present invention may be used in conjunction with the devices and methods disclosed in U.S. Pat. No. 5,329,846 entitled “Tissue Press and System” and U.S. Pat. No. 5,269,785 entitled “Apparatus and Method for Tissue Removal.” For example, an implant secured within the body using the present invention may include tissue harvested, configured, and implanted as described in the patents. The above-mentioned patents are hereby incorporated by reference.

Additionally, it is contemplated that the devices and methods of the present invention may be used with heat bondable materials as disclosed in U.S. Pat. No. 5,593,425 entitled “Surgical Devices Assembled Using Heat Bondable Materials.” For example, the implants of the present invention may include heat bondable material. The material may be deformed to secure tissue or hold a suture or cable. The fasteners made of heat bondable material may be mechanically crimped, plastically crimped, or may be welded to a suture or cable with RF (Bovie devices), laser, ultrasound, electromagnet, ultraviolet, infrared, electro-shockwave, or other known energy. The welding may be performed in an aqueous, dry, or moist environment. The welding device may be disposable, sterilizable, single-use, and/or battery-operated. The above-mentioned patent is hereby incorporated by reference.

Furthermore, the methods of the present invention may be performed under indirect visualization, such as endoscopic guidance, computer assisted navigation, magnetic resonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, or other suitable visualization technique. The implants, fasteners, fastener assemblies, and sutures of the present invention may include a radiopaque material for enhancing indirect visualization. The use of these visualization means along with minimally invasive surgery techniques permits physicians to accurately and rapidly repair, reconstruct, augment, and secure tissue or an implant within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423 disclose apparatus and methods for use in medical imaging. Also, the present invention may be performed using robotics, such as haptic arms or similar apparatus. The above-mentioned patents are hereby incorporated by reference.

Moreover, the devices and methods of the present invention may be used for the repair and reconstruction of a tubular pathway like a blood vessel, intestine, urinary tract, esophagus, or other similar body parts. For example, a blood vessel may be intentionally severed during a surgical operation, or the blood vessel may be damaged or torn as a result of an injury. Flexible fixation of the vessel would permit the vessel to function properly and also compress and stabilize the vessel for enhanced healing. To facilitate the repair or reconstruction of a body lumen, a balloon may be inserted into the lumen and expanded so the damaged, severed, or torn portion of the vessel is positioned against the outer surface of the inflated balloon. In this configuration, the implants and methods described and incorporated herein may be used to approximate the damaged portion of the vessel.

All references cited herein are expressly incorporated by reference in their entirety.