Patent ID: 12232789

SUMMARY

As is described in further detail below, fasteners may be embedded within solidified bondable material, for example a grouting agent such as bone cement (PMMA) or other acrylic based material. In an embodiment in accordance with the invention, an embedding fastener may be connected to an end effector of a vibratory energy generator. The embedding fastener may be adapted to enter and engage the bondable material that has been locally melted by vibratory energy, and to be securely retained therein once the bondable material has cooled and hardened.

The end effector may be provided in any of a variety of shapes, one example being an elongated rod or shaft, connectable to a hand piece at a proximal end, and operative to transmit vibratory energy at a distal end. The fastener may be adapted to connect to the distal end of the end effector, for example by mechanical interlocking, threading, twist lock configurations, friction fitting, or adhesive attachment. The mechanical connection must be operative, however, to communicate the vibratory energy from the end effector to the fastener.

The fastener is adapted to be securely retained within the bondable material or adhesive, in one embodiment, by being provided with a shaped or contoured surface upon which the adhesive may grip once hardened. A roughened or porous surface may be provided alone or in combination with a shaped surface to increase purchase in bondable material and/or facilitate an interference fit.

The fastener may further be provided with a taper at a leading end which first enters the adhesive. The taper improves performance, at least, by promoting accurate tracking and movement of the fastener into the adhesive, piercing tissue, and facilitating initial melting by concentrating vibratory energy over a smaller surface region.

In a further embodiment of the invention, the embedded bone cement fastener (also referred to as an embedding fastener or embedding implant) described above is provided with one or more radial gaps, chambers, or ports, extending from a central bore. A polymeric fastener is inserted within the central bore, and vibratory energy is applied to the polymeric fastener, whereby polymer at the interface between the embedded fastener and the polymeric fastener melts. When the polymer melts, and particularly as pressure is applied to the polymeric fastener in the direction of insertion, polymer enters the ports, flowing in a direction away from the central bore. When vibratory energy is discontinued, the polymer solidifies, and the polymer fastener is thereafter secured within the embedding fastener.

The embodiments of the present invention may be utilized with limitless fixation techniques and in conjunction with other fasteners and implants. Furthermore, the embodiments herein may assist in the installation and removal of tissue and implants. Moreover, the embodiments of the present invention may assist in the delivery of therapeutic agents and employ methods that facilitate tissue growth and repair. In addition, the embodiments herein may be used to apply vibratory energy to remove and/or install an implant in bondable material or to facilitate solidification and/or polymerization of the bondable material.

DETAILED DESCRIPTION

The invention relates to the devices and methods for the utilization of bondable materials and bondable materials, fixation and fastening of tissue to tissue, an implant to tissue, and an implant to an implant both inside and outside the body. The invention additionally relates to removing and anchoring implants to bondable materials and/or other biocompatible materials, anchoring implants using previously implanted and hardened bondable materials, and fixation using vibratory energy, mixing, solidifying, bonding, and/or mechanical interlocking of materials. The present invention also relates to the use of an energy source to install and/or remove an implant or bondable material or to facilitate the solidification and/or polymerization of a bondable material.

The methods and devices disclosed herein may be used in conjunction with any medical procedure on the body. The stabilization, fastening, and/or repair of tissue or an implant may be performed in connection with any medical procedure related to a joint, bone, muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, or other body parts. For example, tissue may be stabilized during intervertebral disc surgery, kyphoplasty, 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.

Also, an implant may be inserted within the body and fastened to tissue with the present invention. Such implant insertion procedures include, but are not limited to, partial or total knee replacement surgery, hip replacement surgery, shoulder replacement surgery, bone fastening surgery, etc. The implant may be an organ, partial organ grafts, tissue graft material (autogenic, allogenic, xenogenic, or synthetic), collagen, a malleable implant like a sponge, mesh, bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal (porous or nonporous), polymer, composite, or ceramic. Collagen may provide the benefit of bolstering tissue growth. Additionally, a desiccated collagen may be used to absorb surrounding fluid, which may provide the additional benefit of applying pressure on the tissue being repaired. Other implants include breast implants, biodegradable plates, porcine or bovine patches, metallic fasteners, compliant bearing for medial compartment of the knee, nucleus pulposus prosthetic, stent, suture, suture anchor, tissue graft, tissue scaffold, biodegradable collagen scaffold, and polymeric or other biocompatible scaffold. The scaffold may include fetal cells, stem cells, embryonic cells, enzymes, and proteins.

In this application, the term “bondable” or “bondable material” is used to refer to the materials discussed herein, as well as any material, suitable for in vivo applications, which can be softened and made flowable by the application of heat (such as heat produced with vibratory energy such as ultrasonic energy), and which, when softened, may become tacky and will bond to other materials and will flow to fill available space. Thus, the material may be thermoplastic, but it may also exhibit tackiness or bonding ability when in its plastic form. Many materials suitable for in vivo applications are made of or incorporate such bondable materials. Generally speaking, the amount of heat needed to soften and make flowable should be within a temperature range that does not produce substantial thermal tissue necrosis. Alternatively stated, the amount of heat required to soften the bondable material during vibratory bonding is substantially confinable, due to the thermal properties of the bondable material, to an area of contact between the objects which are being bonded, thereby protecting living body tissue near the contact between the two objects from substantial thermal tissue necrosis. Any embodiment herein may be used with any of the materials and/or applications disclosed herein or known in the art.

The fixation and fastening system and other embodiments of the present invention contemplates the use any materials that may include or be used in conjunction with bondable materials for bonding and/or staking within the human body. Implants that may be used as fasteners may also be referred to as fastening implants. Bondable material used may include, but are not limited to, biocompatible, 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, bondable material, and combinations thereof. Bondable material may also include polymethyl methacrylate (known as “PMMA” or “bone cement”), glue, adhesive, and/or other grouting agents or acrylic materials used for fixation.

In this application, “bond”, “bonded”, and “bonding” includes, but is not limited to, attaching, engaging, connecting, binding, adhering, and/or fastening one or more materials through resistive heating, mechanical interlocking, application of force, application of grouting agents (i.e. bone cement), adhesives and/or solvents, spraying, radiofrequency, vibratory energy (i.e. ultrasound), microwave, laser, electromagnetic, electro shockwave therapy, plasma energy (hot or cold), and other suitable method described herein or known in the art.

Preferably, materials of the present invention can melt with the application of energy, becoming gel-like, tacky, and/or soft. The energy source and the technique used to bond and/or stake the material within the body can be selected to minimize or avoid damage to surrounding body tissue. Exemplary materials that may be used may include polymers, ceramics, composites, and metals, although other materials may also be suitable for use with the invention. While the present invention contemplates the use of any of these materials in any of the following embodiments, polymeric material is used in the following examples and description simply to illustrate how the invention may be used.

There are a limitless number of materials may be used for the present invention. Examples of amorphous polymers are polycarbonate (LEXAN), polystyrene, polysulfone (ULDALL), and acrylics polycarbonate (ABS and styrenes). Examples of semi-crystalline polymers include acetyl (DELRIN), nylon, polyester, polyethylene, polyether ether ketone, polypropylene, polyvinylchloride (PVC), and Caprolactam. Biodegradable semi-crystalline polymers may include polylactic acid and polyglycolic acid. Copolymers of PGA and PLA may also be used. Poly-1-lactide (PLLA) or other forms of PLA may also be used. Other polymers which may be used with the present invention, either as a thermoplastic or non-thermoplastic, are polyethylene glycol (PEG)-copolymers and D,L-lactide-co-glycolide polyesters. Some semi-crystalline materials are particularly suitable for surgical bonding and/or staking, especially vibratory bonding and staking. Examples of such materials include PAEK (polyaryletherketone), including PEEK (polyetheretherketone) and PEKK (polyetherketoneketone).

In addition to PEEK and the other polymers described herein, the implants, devices, and methods of the present invention may use keratin, a naturally occurring polymer. Keratin may be vibratory bonded or staked to itself, to other implants, or within tissue. This may be performed in the operating room or intracorporeally. Keratin may be bonded to collagen or to other known polymers. In an exemplary application, keratin may be used to fasten tissue to bone since keratin has BMP and tissue scaffold properties. It is contemplated that any of devices and methods disclosed herein may utilize keratin alone or in combination with PEEK, polylactic acid, or other polymer. Keratin may be used to make fasteners, disc replacements, joint replacement components, stents, cell scaffolds, drug reservoirs, etc. Also, joint bearing surfaces may include keratin with or without collagen or chondrocytes. The bearing surfaces may be fastened to a joint component using PEEK or PLA fasteners.

Another polymer that can be used with the present invention is a class of natural materials, called polyhydroxyalkanoates, or PHA polymers. These polymers are synthesized in nature by numerous microorganisms, and they have been recently recognized as the fifth class of naturally occurring biopolymers (along with the polyamino acids, polynucleic acids, polysaccharides, and polyisoprenoids). Unlike the other naturally occurring biological polymers, however, the PHA polymers are thermoplastic, i.e. they may be repeatedly softened with heat and hardened with cooling. As such, these polymers can be processed much like other plastics. A specific example of a PHA polymer that could be used is poly-4-hydroxybutyrate material. Such PHA polymers are available from Tepha Inc of Lexington, MA.

Fasteners of the invention may utilize or be coated with polymethylmethacrylate (PMMA), in order to promote bonding with PMMA used in the body, or PMMA could be incorporated into polymer of the fastener, or deposited within cavities or shapes formed in the fastener surface, including threaded, roughened, porous, or nano textures. A fastener may be thus coated with PMMA, or formed entirely of PMMA, and may be heat bonded, advantageously using ultrasound, to another PMMA surface or other adhesive surface, otherwise as described herein with respect to bone cement. Although PMMA, known generally as bone cement, and other polymers may function more as a grouting agent than a cement or adhesive. The term “bondable material” is used throughout the specification for simplicity.

In accordance with the invention, metals are advantageously connected with fasteners incorporating polymeric materials. Any of a variety of metals may be used, either smooth or formed with at least portions formed of metal, or a roughened or porous surface, or formed with cavities or other shapes upon which polymeric material may mold, enter, adhere, or otherwise affix. The polymer is softened in accordance with the invention through the application of heat, including heat created using vibratory energy, to become tacky, or sufficiently softened in order to bond on a microscopic level, or a macroscopic level through adaptation to the surface structure of the metal. For use in vivo, biocompatible metals are used, including stainless steel, nitinol or other SMA (shape metal alloy), tantalum, porous tantalum, titanium, cobalt-chrome alloys, and other metals such as are known to those skilled in the art. Additional related information, including bonding polymers and metals, and polymer to polymer bonding of implant materials, may be found in U.S. Pat. No. 5,163,960 entitled “Surgical devices assembled using bondable materials”, and U.S. Pat. No. 7,104,996 entitled “Method of performing surgery”, the contents of each of which being incorporated herein by reference.

The fastening device of the present invention may include therapeutic substances to promote healing. These substances could 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, and combinations thereof. These therapeutic substances may be combined with the materials used to make the device. Alternatively, the therapeutic substances may be impregnated or coated on the device. Time-released therapeutic substances and drugs may also be incorporated into or coated on the surface of the device. The therapeutic substances may also be placed in a bioabsorbable, degradable, or biodegradable polymer layer or layers.

The therapeutic agents may also be placed within one or more cavities disposed in a fastening device of the present invention. Different agents may be disposed in different cavities of the device to specifically tailor the implant for a particular patient. Dosages of the therapeutic agent may be the same or different within each of cavities as well. The cavities may include a cover which may release the agent in a controlled or timed manner. The cover may be biodegradable or bioerodible to allow the agent to release to surrounding tissue. Examples of suitable therapeutic agents include bone growth inducing material, bone morphogenic proteins, osteoinductive materials, apatite compositions with collagen, demineralized bone powder, or any agent previously listed. U.S. patent application Ser. No. 11/549,994 entitled “Drug Eluting Implant” discloses means for delivering therapeutic agents. The above-mentioned patent application is incorporated by reference herein in its entirety.

The fastening devices of this and other embodiments of the invention may be used in combination with fasteners in the prior art. Examples of fasteners, implants, and their methods of employment may be found in U.S. Pat. Nos. 5,163,960; 5,403,348; 5,441,538; 5,464,426; 5,549,630; 5,593,425; 5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073; 5,845,645; 5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,086,593; 6,099,531; 6,159,234; 6,368,343; 6,447,516; 6,475,230; 6,592,609; 6,635,073; and 6,719,765. Other fastener types are disclosed in U.S. patent application Ser. Nos. 12/202,210; 10/102,413; 10/228,855; 10/779,978; 10/780,444; and Ser. No. 10/797,685. The above cited patents and patent applications are hereby incorporated by reference in their entirety.

With reference toFIG.1, any known energy emitting instrument may be used with the surgical system of the present invention. Instrument100may produce energy such as resistive heating, radiofrequency, ultrasound (vibratory), microwave, laser, electromagnetic, electro shockwave therapy, plasma energy (hot or cold), and other suitable energy disclosed herein or known in the art.FIG.1illustrates an exemplary handpiece or instrument100that may be used with the present invention. The instrument100may be a vibratory energy generator with a sheath102to cover and protect the end effector104and engage a fastener/implant near engagement feature106. As will be discussed below, the instrument may be used to bond and/or mechanically interlock fasteners and other embodiments the present invention. Additional embodiments of instrument100are disclosed in U.S. patent application Ser. No. 12/202,210 entitled “Methods and Devices for Utilizing Thermal Energy to Bond, Stake and/or Remove Implants”, which is incorporated by reference herein.

With reference toFIGS.2-7, end effector104may be utilized with anchor or embedding fastener110. Embedding fastener110may also be referred to as an embedding implant.FIG.2illustrates end effector104that connects to embedding fastener110with distal end108. The connection between distal end108and embedding fastener110may utilize threads, magnetism, friction, taper, ball and socket, linkage, adhesive, interlocking shapes, and other connections known in the art. Additionally, distal end108and embedding fastener110may be permanently or detachably connected.

As shown inFIG.2, embedding fastener110may further be provided with a taper114, which first enters bondable material120inFIG.4. Taper114may improve performance, for example, by promoting accurate tracking and movement of embedding fastener110into bondable material120, piercing body tissue, and facilitating initial melting by concentrating vibratory energy over a smaller surface region. Although embedding fastener110may be made of any material described herein or known in the art, it may be preferable to use titanium.

As discussed in further detail below, embedding fastener110may also have feature112and/or feature116, either or both may be a surface feature, recess, or pass through a portion or the entirety of embedding fastener110.

Referring toFIG.3, an embodiment of end effector104may have proximal end118to the other components of instrument100. The connection between instrument100and proximal end118may be threaded, magnetic, friction, hex, ball and socket, linkage, adhesive, and other methods disclosed herein or known in the art.

As shown inFIGS.3-7, end effector104may be provided in any of a variety of shapes, one example being an elongated rod or shaft, connectable to a hand piece at a proximal end118, and operative to transmit vibratory energy at a distal end108. While a rod shape is shown and selected for reduced manufacturing cost, end effector104may have the form of box or hex channel, oval or other shape, provided it communicates vibratory energy to a distal end108, an attached fastener, or embedding fastener110. Additionally, feature111ofFIG.5may be used on embedding fastener110or integrated into end effector104(not shown).

In an additional embodiment, embedding fastener110is adapted to connect to distal end108of end effector104by mechanical interlocking, as by a bore in embedding fastener110, sized to receive distal end108of end effector104, optionally provided with internal or external threading (not shown), wherein post108has mating threads. Additionally, the connection may be threaded, magnetic, friction, hex, ball and socket, linkage, adhesive, and other methods disclosed herein or known in the art. Similarly, a bore or aperture may be provided in end effector104, mateable with a post or projection on embedding fastener110. Other mechanical connections are contemplated, including twist lock configurations, friction fitting, or adhesive attachment. The mechanical connection should preferably be operative to communicate vibratory energy from end effector104to embedding fastener110, as by a firm mechanical connection.

As shown in an embodiment ofFIG.4, embedding fastener110may be adapted to be securely retained within bondable material120by being provided with a shaped or contoured surface upon which the softened bondable may adhere. A roughened or porous surface may be provided alone or in combination with shaped surface thereby providing for increased purchase in bondable material120.

With reference toFIG.4, embedding fastener110may be embedded within solidified bone bondable material120, for example PMMA, acrylic based adhesive, or other bondable materials. In the present invention, embedding fastener110is connected to end effector104of an embodiment of instrument100, such as a vibratory energy generator as shown inFIG.1. Embedding fastener110is adapted to enter and engage bondable material120or bondable material120that has been locally melted by vibratory energy (as shown inFIG.4), through contact between embedding fastener110and bondable material120during operation of instrument100. Embedding fastener110is securely retained by bondable material120once the latter has hardened. Although the embodiment inFIG.4may be used under a limitless number of configurations and settings, Table 1 is being set forth with operative examples:

TABLE 1Titanium Embedding Fastener Bonded into PMMAEmbedding Fastener Type: Shown in FIG. 20Instrument: Handpiece SN0105 with tuning of 39,000-45,000 HzSystem Settings:Sample 1: 40,850 Hz, 1OO W, 2.0 sec weld timeSample 2: 40,750 Hz, 75 W, 1.5 sec weld timeSample 3: 40,800 Hz, 75 W, 1.0 sec weld timeSample 4: 40,750 Hz, 75 W, 1.0 sec weld timeForceTest SamplePowerApplied toDeformationNumber(watts)Time (sec)Break (lbs.)Depth (inches)1632.5646.70.1162482.0161.90.1193481.5832.50.1094481.4731.50.098

Once anchored, end effector104and embedding fastener110, embedded in bondable material120, may remain connected. Alternatively, end effector104may be removed and another fastener of a similar or different design may be connected to an implanted embedding fastener110as shown inFIGS.8-10. In a further embodiment, fastener124such as described in the incorporated patents and applications may be fastened to an implanted or installed embedding fastener110. Fastener124may have fastener bore128as shown inFIGS.8-9. Referring toFIG.10, a bondable insert134may be secured into fastener bore128. Bondable insert134may be secured by press fitting, threading, or bonding to fastener bore128and/or embedding fastener110. The fastener124may be utilized as detailed in U.S. patent application Ser. No. 12/202,210, which has been incorporated by reference herein. In further embodiments, any fastener described in the related references cited herein above or discussed herein may be fastened to the embedding fastener110, then secured in its respective manner.

In an additional embodiment, embedding fastener110may be used to remove an implant and/or bondable material120. For example, the ability of conventional medical tools to remove a previously installed implant or bone cement may be limited. Embedding fastener110may be used to obtain additional fixation. Once embedding fastener100is secured to the implant and/or bondable material120, force and/or vibratory energy may be used to remove the implant and/or bondable material120.

FIGS.11-17show an additional embodiment for use with an implanted embedding fastener110. Fastener136is show inFIGS.11-12and washer146is shown inFIGS.13-14. Although fastener136and washer146may be made of any material disclosed herein or known in the art, it may be preferable to use PEEK. After embedding fastener110has been secured with respect to bondable material120, fastener136may be engaged into embedding fastener110. In another embodiment, washer146may be used in conjunction with fastener136as shown inFIGS.15-17. Additionally, fastener136may be bonded to embedding fastener110and/or washer146.

Referring toFIGS.18-19, fastener136, washer146, and/or tissue implant154may be used to secure soft tissue152to hard tissue156, for example to secure the rotator cuff tissue to the proximal humerus or for any other procedure disclosed herein. Additionally, washer146and/or tissue implant154could be made of collagen or other materials that promote tissue growth.

With reference toFIGS.20-25, embedding fastener110may be provided with channel112. For example, channel112A,112B,112C, and/or116may be used. Channel112may extend through the surface of embedding fastener110to facilitate the bonding of embedding fastener110to bondable material120, fastener136, and/or any fastener disclosed herein. Channel112may provide a path for softened and/or molten bondable material to be displaced, providing room for entry of embedding fastener110. Channel116may also include radial gaps, chambers, or ports. To accommodate for embedding fastener110displacing a substantial amount of material, channels may be extended along the entire length of embedding fastener110, and may further extend along end effector104. Channel116may be further operative to reduce the possibility of rotation of fastener110within bondable material120. Channel116is thus disposed to extend into bondable material120after insertion, and may extend to the face of embedding fastener110. Additionally, embedding fastener110may have feature158to help attach and remove it from end effector104.

In an embodiment shown inFIGS.26-27, implant162may be coated in bondable material164and implanted in body tissue160. For example, a metal rod coated with bone cement may be placed in the intramedullary canal of a bone. In an embodiment, support168may be placed in a location to facilitate stabilization. Support168and/or washer146may be referred to as a supporting implant. One or more holes may be formed in body tissue160and up to or into bondable material164to coincide with the holes in support168. Embedding fastener110may be placed through the holes in body tissue160and secured to and/or bonded to bondable material164as discussed herein. Then, one or more of fastener136are secured to and/or bonded to the one or more embedding fastener110, thereby securing support168relative to body tissue160.

Referring toFIG.28, implant162may be installed in a body tissue160with bondable material164, for example bone cement. Bondable material164may be any material described herein or known in the art. Implant162may require stabilization because implant162has become loose and/or requires stabilization due to tissue defect166, for example a periprosthetic fracture. Tissue defect166may include, but is not limited to, damaged, deformed, and/or diseased bone, muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, or other body part. For example, a femur may be fractured or contain osteoporosis. Support168is fixed to body tissue160with fastener170to provide stabilization. Support168may be an internal bone plate, an external bone plate, a spinal plate, a wedge, a cushion, a pad, or other biocompatible support used for stabilization of tissue and/or implants. Fastener170may be any fastener described herein or any other biocompatible fastener known in the art.

In an embodiment, implant162has been previously installed and requires stabilization. One or more holes are formed through body tissue160and up to or into bondable material164. Embedding fastener110is inserted through a hole and bonded to bondable material164by utilizing instrument100described above. Fastener170engages embedding fastener110to secure support168to body tissue160. The head of fastener170may be deformed and/or bonded to support168to reduce loosening of fastener170.

Embedding fastener110can also be bonded to bondable material164C/D that is within or on the surface of body tissue160. For example, bondable material may have been used to repair tissue defect166. Bondable material164may be within or on the surface of body tissue160. A hole is formed up to or into the bondable material164. Embedding fastener110is bonded into bondable material164. Fastener170passes through support168and into engagement with embedding fastener110to secure support168relative to body tissue160.

In another embodiment, embedding fastener1I OA/B can be bonded to and/or into implant162. The procedure is performed as described above, except the embedding fastener110may be bonded directly to implant162.

In another embodiment, bondable material164may asymmetrically cover all or a portion of implant162. The thickness of bondable material164could vary in the radial direction or along the length of implant162. An asymmetrically coated implant162may provide additional purchase for fastener136or indication of orientation or position of implant162.

In an additional embodiment, indirect visualization may be used to identify and/or change the orientation or position of implant162or fastener136. Examples of indirect visualization may include endoscopic guidance, computer assisted navigation, magnetic resonance imaging (MM), CT scan, ultrasound, fluoroscopy, X-ray, or other visualization technique disclosed in any of the references incorporated herein. Asymmetric coating, radiopaque markers, or other features identifiable with indirect visualization may be used to identify and/or adjust orientation or position. Indirect visualization may also be used to align fastener136with holes in implant162or bondable material164. The holes may be predrilled in implant162or bondable material164or may be drilled after installation of162. Indirect visualization may be used to create a hole or holes in tissue to align with holes in implant162or bondable material164.

For example, an intramedullary rod could be asymmetrically coated with PEEK. The intramedullary rod could have predrilled holes in the PEEK coating. After the rod is installed in the intramedullary canal of the tibia, the orientation of the rod may be determined using indirect visualization to locate the area with a thicker coating. The orientation of the rod may be adjusted to the appropriate location for holes to be made through the tissue.

With further reference toFIG.28-29, various types of fastening devices are used to position support168along body tissue160. Alternatively, support168may be positioned upon the surface of the skin, or at any point between the tissue surface and the skin, according to the requirements of the surgical procedure. Further, support168may be placed within the bone, for example in an intramedullary canal.

Referring toFIG.29, fastener170may be used in intramedullary, percutaneous, and/or retrograde approaches. Fastener170may be bonded to bondable material164, or a surface of implant162. The head of fastener170may be provided, or may be formed using vibratory energy. A head may also be formed on the distal end of fastener170. Fasteners170E are shown to be bonded into the bondable material164. Fastener170F is shown to be bonded at the distal end and/or to bondable material164within the body tissue and is placed through tissue defect166. Fasteners170G are shown passing directly through body tissue160, which may be fastener170T and sleeve171T inFIGS.52-53and as described below. Additional embodiments of fastener170are disclosed in U.S. patent application Ser. No. 12/202,210 entitled “Methods and Devices for Utilizing Thermal Energy to Bond, Stake and/or Remove Implants”, which is incorporated by reference herein.

Additionally, cerclage wire172may be employed as known in the art, to provide further stabilization, in combination with fastener170. For example, cerclage wire172A may be bonded to support168. Bondable material164E could be used to affix cerclage wire172A to support168. In another example, cerclage wire172B may be tied around support168. Also, cerclage wire172C may be fastened using a mechanical or bonded crimp174. In additional example, cerclage wire172D may be fastened to the side of support168or between support168and body tissue160.

Referring toFIG.30, end effector104of instrument100may be connected into implant162at recess180. This connection may be threaded, magnetic, friction, hex, ball and socket, linkage, adhesive, and other connections suitable for transferring vibratory energy as disclosed herein or known in the art. Also, other vibratory energy devices as disclosed herein or known in the art may be utilized.

FIG.30also shows additional methods of stabilizing a loose implant and/or facilitating the solidification and/or polymerization of bondable material164. For example, fastener170H may be a metal and/or polymer fastener, which may be affixed to the bondable material164and/or implant162to stabilize implant162. In another example, fastener1701may be metal coated with bondable material. Upon the application of vibratory energy and/or heat, distal end182A deforms thereby stabilizing the gap between implant162and body tissue160. In an additional example, fastener170J may be made of bondable material. Upon the application of vibratory energy and/or heat, distal end182B deforms, thereby stabilizing the gap between implant162and body tissue160.

Referring toFIG.31, end effector104of instrument100may be connected into implant162with coupler184to stabilize previously hardened and/or polymerized bondable material164or to facilitate solidification and/or polymerization of bondable material164. This connection may be threaded, magnetic, friction, hex, ball and socket, linkage, adhesive, and other connections suitable for transferring vibratory energy as disclosed herein or known in the art. Also, other vibratory energy devices disclosed herein or known in the art may be utilized.

Referring toFIG.32, attachment186may be attached and/or bonded to implant162. Attachment186may be made from any material described herein (i.e. collagen, graft, or growth promoter) or any other material known in the art, preferably to promote healing and/or contain bondable material164. For example, vibratory energy may be used to bond attachment186to implant162. In another example, fastener170may secure attachment186to implant162. In an additional example, vibratory energy may be used to bond fastener170to attachment186.

Referring toFIGS.33-34, implant162may be manufactured with reservoir192or reservoir192may be formed during or after implantation. Additionally, therapeutic substance194may be incorporated in reservoir192of implant162, impregnated in implant162, or coated on or in implant162. As shown inFIG.33, reservoir192may be located in implant162. Alternatively, reservoir194may be formed in body tissue160, as shown inFIG.34. Cap188may be made of bondable material. Additionally, cap188may be attached and/or bonded to enclose reservoir192. Implant162, cap188, and/or body tissue160may contain attachment feature190and/or attachment recess196to facilitate mechanical attachment and/or bonding with end effector104. Additionally, implant162, cap188, and/or bondable material164may be porous to facilitate the delivery of therapeutic substance194.

Referring toFIG.35, therapeutic substance194may be contained in implant198, for example drugs or antibiotics contained in an acetabular cup. Implant198may be manufactured with reservoir192A and/or reservoir192B or the reservoirs may be formed during implantation. Any combination of one or more reservoir192A and/or reservoir192may be used. Cap188may be coated with bondable material. Additionally, any of caps188A-D may be attached and/or bonded to enclose reservoir192A or192B, which may provide the potential benefit of multiple release times for therapeutic substance194Caps188A-D may contain attachment features190A-D to facilitate mechanical attachment and/or bonding. Additionally, implant198and/or any of caps188A-D may be porous to facilitate the delivery of therapeutic substance194.

Referring toFIG.36, fastener170may be used to stabilize implant162, for example a tibial component of a total knee arthroplasty (TKA). In an embodiment, fastener170K may be bonded to bondable material164on the underside of the implant or bonded directly to implant164. In another embodiment, fastener170L may be bonded to the portion of implant162that is within body tissue160. In an additional embodiment, fastener170may be used to secure tissue graft202to implant162and/or body tissue160. For example, tissue graft202may be an allograft. Any embodiment of fastener170that has been described herein or known in the art may be used.

Referring toFIGS.37-38, bondable material164may be utilized to stabilize body tissue160. For example, bone cement in previously performed kyphoplasty may become loose and require additional stabilization. In this example, the fasteners may utilize the previously implanted bone cement to stabilize the spine instead of removing and reapplying bone cement. In an embodiment, body tissue160has been previously implanted with bondable material164. Fastener170N is passed through support168and bonded to bondable material164. As shown inFIG.37, one or more fastener170is passed through support168and secured and/or bonded to surrounding tissue200. Fasteners170M,170N, and170P may be any embodiment disclosed herein or known in the art. Additionally, fasteners170M,170N, and170P may be used with embedding fastener110as described above. Also in these embodiments, vibratory energy may be used to stabilize previously hardened and/or polymerized bondable material or to facilitate the solidification and/or polymerization of bondable material.

Referring toFIGS.39-41and50-51, an additional embodiment of instrument100includes guide sheath102, spring204, and/or force regulator206. In an embodiment inFIG.41, guide sheath102may align washer146when the tip of end effector104is placed in contact with fastener136. As fastener138is staked and the tip of fastener136is shaped with the application of vibratory energy, such as ultrasonic energy, guide sheath102may allow end effector104to advance while applying force to washer146, support168, body tissue160, and/or bondable material164(not shown inFIG.41). In a further embodiment inFIG.41, guide sheath102may hold, guide, align, and/or deliver washer146, fastener136, or other fasteners referenced herein or known in the art. In an additional embodiment, regulating sheath206may have a spring204, for example any spring, cushion, or other material or device known in the art for spring/damping applications. Additionally, instrument100may have regulating tab206for manually applying and/or regulating the movement of guide sheath102. Although the embodiment inFIG.41may be used under a limitless number of configurations and settings, Table 2 is being set forth with operative examples:

TABLE 2Polycarbonate Fastener BondingInstrument: Handpiece P05 with tuning of 39,000-45,000 HzSystem Settings: 39,500 Hz, SOW, 1.0 sec weld timeEnergyForceTest SamplePowerApplicationApplied toDeformationNumber(watts)Time (sec)Break (lbs.)Depth (inches)1301.6993.20.1152281.6886.40.1103311.7898.20.1114271.8091.30.1085311.69109.20.109

In additional embodiments, frequency may preferably be between 20 to 80 khz, power may preferably be between 5 to 200 watts, and energy application time may be preferably between from 0.1 to 5 seconds.

In an embodiment, a sensor may be included in instrument100. For example, a force, pressure, or temperature sensor may be used to measure bonding and/or staking. In another example, a visual and/or audio indicator may be operatively connected to the sensor, which may be used to indicate a proper bond/stake. In another embodiment, a visual and/or audio indicator may be connected to instrument100or the energy generator, which may be used to illustrate and/or teach proper technique during bonding and/or surgery. In another example, the visual and/or audio indicator may indicate completion of a proper bond/stake, over/under application of force, or expiration of desired energy application time.

In another embodiment, a vacuum may be operatively connected to 100. For example, the vacuum may be communicatively connected between the guide sheath102and end effector104, which may be used for the removal of debris from instrument100.

Referring toFIGS.42-43, an additional embodiment of fastener170may include one or more feature208. Feature208may increase or decrease the transfer of energy across fastener170. Feature208may pass into the surface or through fastener170. Feature208may be on any surface or surfaces of fastener170and/or contain therapeutic substances. Fastener170may include effector interface210, preferably for engagement with end effector104.

Referring toFIGS.44-45, embedding fastener110may also include thread212. Embedding fastener110may be screwed and/or engaged into bondable material, tissue, and/or any other material disclosed herein, preferably by engaging interface214with a screw driver or other tool. Embedding fastener110may include an interface214which may be radiused, chamfered, funnel-shaped, threaded, or any other shape, for example square, rectangular, circular, elliptical, triangular, hexagonal, or asymmetrical shape. Embedding fastener110may be made of any metal, polymer, or other material disclosed herein.

Referring toFIGS.46-47, fastener170may include effector interface216. Preferably for engagement with end effector104, effector interface216may be radiused, chamfered, funnel-shaped, threaded, or any other shape, for example square, rectangular, circular, elliptical, triangular, hexagonal, or asymmetrical shape.

Referring toFIGS.48-49, instrument100may include end effector104dimensioned and configured for a point of maximum displacement at or near the middle of fastener170at or near point218B (FIG.49). In another embodiment, it may be preferable for instrument100to include end effector104dimensioned and configured for a point of maximum displacement at or near the end of fastener170at or near point218A (FIG.48). For most applications, a point of maximum displacement at or near point218B is preferred. Fastener170may be threaded or have an interference fit with end effector104.

A point of maximum displacement along end effector104may occur at increments of about half its wavelength, which may be determined by the ratio of the speed of sound through the material of end effector104to the frequency of the wave propagated through end effector104. The end effector104may be made of titanium or any material disclosed herein. For example, at a frequency of 20 khz, points of maximum displacement along end effector104made of titanium may be in increments of about 4 to 6 inches, preferably 4.8 to 5.1 inches. For example, at a frequency of 40 khz, points of maximum displacement along end effector104made of titanium may be in increments of about 2 to 3 inches, preferably 2.4 to 2.5 inches

A point of maximum displacement along fastener170may also occur at increments of about half its wavelength. Fastener170may be made of PEEK, PLLA, or any material disclosed herein. As an example for PEEK, at a frequency of 20 khz, points of maximum displacement along end effector104may be in increments of about 1 to 2 inches, preferably 1.6 to 1.7 inches. As another example for PEEK, at a frequency of 40 khz, points of maximum displacement along end effector104may be in increments of about 0.5 to 1 inch, preferably 0.8 inches. As an example for PLLA, as an example at a frequency of 20 khz, points of maximum displacement along end effector104may be in increments of about 1 to 2 inches, preferably 1.3 to 1.4 inches. As an example for PLLA, as an example at a frequency of 40 khz, points of maximum displacement along end effector104may be in increments of about 0.5 to 1 inch, preferably 0.7 inches.

To optimize bonding and/or reduce the stress applied, the desired point of bonding on fastener170should be at or near a point of maximum displacement. For example, the desired point of bonding on fastener170may be along half its length or at its tip (see218A ofFIG.48). If the desired point of bonding is at a point of minimal or zero displacement (see218B ofFIG.49), bonding may be difficult. To facilitate bonding, it may be preferable to increase power or amplitude of the signal, thereby increasing energy applied to fastener170.

Referring toFIGS.52-53, fastener170T may be used with sleeve171T, potentially to contain and/or release therapeutic substances into a body. Fastener170T may engage with sleeve171T by mechanical interlock, thread, or vibratory energy bond. End effector104may engage with fastener170T for vibratory energy bonding. Any fastener170disclosed herein may have energy director222to facilitate bonding by directing energy to the desired location of bonding.

Referring toFIGS.54-55, fastener170U may have energy director224. Energy director224may facilitate bonding with implant162, especially if a portion or the entirety of implant162includes a porous material. For example, implant162may include a porous metal. End effector104may engage with fastener170U for vibratory energy bonding.

Referring toFIG.56, fastener170F may be embedded into a bondable material with its leading end and stabilize a support168(i.e. plate) with its trailing end. End effector104may engage with fastener170F, preferably near the trailing end, for vibratory energy bonding. Fastener170F may include any material disclosed herein, but preferably titanium or titanium with at least a portion coated with PEEK or PLLA.

Referring toFIGS.57-58, fastener170W may be used with, preferably disposed within, expanding anchor226. End effector104may engage with fastener170W, preferably near the trailing end, for vibratory energy bonding. A hole in tissue and/or bondable material may be formed or drilled into body tissue160prior to or during the implantation of fastener170W and expanding anchor226. Fastener170W and expanding anchor226may pass into body tissue160, for example in the configuration shown inFIG.57. Fastener170W may be retracted into expanding anchor226, preferably after being positioned in body tissue160. Expanding anchor226may expand outwards (shown inFIG.58), thereby engaging and/or exerting a radially outward force on body tissue160. Preferably after fastener170W and expanding anchor226are in an expanded condition, vibratory energy may be applied to fastener170W, preferably near the trailing end, to bond fastener170W and expanding anchor226together. In another embodiment, fastener170W and/or expanding anchor226may be configured to bond into a bondable material. After fastener170W and expanding anchor226have been stabilized in the expanded configuration, the excess length of the trailing end of fastener170W may be removed to be substantially flush with the trailing end of expanding anchor226.

Referring toFIG.59, fastener170may be used to increase interference between body tissue160and implant198. Fastener170may be an interference screw and/or used in conjunction with interference implant228to position and/or stabilize implant198. Fastener170may pass through all or a portion of implant198. In additional embodiments, fastener170may stabilize body tissue160(i.e. ACL graft) against the side of a hole in body tissue160(i.e. bone) (not shown), stabilize body tissue160(i.e. soft tissue) to another body tissue160(i.e. bone), or stabilize interference implant228(or tissue graft202) to body tissue160(i.e. bone) and/or implant198(FIG.59). In another embodiment, fastener170may be part or entirely made of a biodegradable and/or bondable material. In an embodiment, fastener170may have a snap that would overlay part of implant198for interference. In another embodiment, implant198may include porous surface230(FIG.59) or a coating of bondable material. In another example, implant198may be bonded with vibratory energy, hydrophilic, and/or mechanically expandable against body tissue160(i.e. bone), which may allow the implant to sequentially expand and provide interference against body tissue160(i.e. bone) or another implant.

In an embodiment related to hip (or shoulder) resurfacing, implant198may be an acetabular component or cup (or glenoid component), which is commonly stabilized using screws through its center. To replace the use of these screws or to provide additional stabilization, implant198may be stabilized by positioning fastener170between implant198and body tissue160(i.e. acetabulum or glenoid), which may urge implant198to the desired position and/or enhance interference with body tissue160. In an embodiment, implant198may be free of holes, as fastener170may provide the majority of interference.

There are many different features to the present invention and its contemplated that these features may be used together or separately. Thus, the invention should not be limited to any particular combination of features or to a particular application of the invention. Further, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention.