WO2018031752A1 - Installation de prothèse - Google Patents

Installation de prothèse Download PDF

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Publication number
WO2018031752A1
WO2018031752A1 PCT/US2017/046261 US2017046261W WO2018031752A1 WO 2018031752 A1 WO2018031752 A1 WO 2018031752A1 US 2017046261 W US2017046261 W US 2017046261W WO 2018031752 A1 WO2018031752 A1 WO 2018031752A1
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WO
WIPO (PCT)
Prior art keywords
bone
force
tool
interface
prosthesis
Prior art date
Application number
PCT/US2017/046261
Other languages
English (en)
Inventor
Kambiz BEHZADI
Original Assignee
Behzadi Kambiz
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/362,675 external-priority patent/US10660767B2/en
Priority claimed from US15/398,996 external-priority patent/US10251663B2/en
Priority claimed from US15/453,219 external-priority patent/US10426540B2/en
Application filed by Behzadi Kambiz filed Critical Behzadi Kambiz
Publication of WO2018031752A1 publication Critical patent/WO2018031752A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4637—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for connecting or disconnecting two parts of a prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/142—Surgical saws ; Accessories therefor with reciprocating saw blades, e.g. with cutting edges at the distal end of the saw blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1659—Surgical rasps, files, planes, or scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip
    • A61B17/1666—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B2017/1602—Mills

Definitions

  • the present invention relates generally to installation of a prosthesis, and more specifically, but not exclusively, to non-impactful installation of an acetabular cup into an acetabulum during total hip replacement procedures as well as to improvements in prosthesis placement and positioning.
  • An embodiment of the present invention may include implementation of a constant velocity relative motion between a prosthesis and an installation site.
  • an installation system may be fixed relative to the installation site, with the prosthesis fixed into an initial position.
  • the prosthesis is moved at constant speed (i.e., with minimal if any acceleration or applied impulses) relative to the installation site. That is, one or both of the prosthesis or the installation site may be in motion.
  • a hip may be fixed in place on an operating platform and the installation tool secured to the platform and/or to the hip. The tool is advanced toward the hip to insert the prosthesis into the installation site.
  • the hip may be moved toward the installation tool, such as by fixing the installation tool above the operating platform and then elevating the platform at a constant speed.
  • the installation tool may be part of a robotic tool to help provide accurate orientation during installation.
  • a surface modification or a surface treatment of the surface of the prosthesis engaging the installation site may further reduce the resistive forces.
  • the surface treatment may vary, for example, and include unidirectional surface elements for biasing the installation or use of a paste, cream, slurry, and/or ice to provide a low resistive film.
  • An embodiment of the present invention may include axial alignment of force transference, such as, for example, an axially sliding hammer moving between stops to impart a non- torqueing installation force.
  • force transference such as, for example, an axially sliding hammer moving between stops to impart a non- torqueing installation force.
  • Optional enhancements may include pressure and/or sound sensors for gauging when a desired depth of implantation has occurred.
  • Still other embodiments include an alignment system to improve site preparation, such as, for example, including a projected visual reference of a desired orientation of a tool and then having that reference marked and available for use during operation of the tool to ensure that the alignment remains proper throughout its use, such as during a reaming operation.
  • Further embodiments include enhancement of various tools, such as those used for cutting, trimming, drilling, and the like, with ultrasonic enhancement to make the device a better cutting, trimming, drilling, etc. device to enable its use with less strength and with improved accuracy.
  • An embodiment of the present invention may include a grip structure on a body of modular assembly that may provide an anchor for defining an alignment axis for a trunnion of the body and a head to be installed onto the trunnion.
  • An embodiment of the present invention may include a head grasper that secures the head into an optimized assembly position relative to the alignment axis/trunnion.
  • the optimized assembly position may include non-relative canting and alignment with the alignment axis.
  • An embodiment of the present invention may include a holder that engages a grip structure and is coupled to a head grasper.
  • the holder may aid in reducing waste of energy used in assembly of the head onto the trunnion and it may aid in the optimized positioning of the head relative to the alignment axis/trunnion before and/or during installation of the head onto the trunnion.
  • An embodiment of the present invention may include use of force source coupled to a head grasper/tool to generate assembly forces to install the head onto the trunnion.
  • the force source may deliver one or more of a dynamic assembly force, a vibratory assembly force, a set of discrete assembly impacts, other assembly forces, and combinations thereof.
  • the assembly force(s) may be applied the head grasper/tool to install the head onto the trunnion.
  • the assembly force(s) may be constrained to operate along the alignment axis, and may be reduced by securing/anchoring the body of the modular prosthesis, such as by using a grip structure.
  • An embodiment of the present invention may include use of a force sensing mechanism coupled to a head grasper/tool to measure, possibly in true realtime (e.g., during dynamic operation of the tool to apply the assembly force(s)), the assembly force(s).
  • An embodiment of the present invention may include development and production of standards, guidelines, recommendations for an optimum force, or force range for the assembly force(s) to achieve a desired cold weld.
  • An apparatus for acting on a portion of bone including a force transfer anchor fixed to the portion of bone, the force transfer anchor including a tool mount; and a tool, coupled to the tool mount, including an operational end configured to interface with the portion of bone using an interface force; wherein a portion of the interface force is transferred between the portion of bone and the tool through the force transfer anchor.
  • a method for acting on a portion of bone including a) fixing a force transfer anchor to the portion of bone, the force transfer anchor including a tool mount; b) interfacing a tool, coupled to the tool mount and with the tool including an operational end, with the portion of bone using an interface force; c) transferring a portion of the interface force between the portion of bone and the tool through the force transfer anchor.
  • An embodiment of the present invention may include a system having a portion of a living bone of a patient or other foundation, a tool for acting upon that portion of bone or foundation, and a force transfer anchor that secures, constrains, and/or fixes a known relative relationship between the tool and the portion of bone or foundation.
  • a wide range of tools may be used for acting directly or indirectly on the portion of bone (e.g., milling, subtracting, or removing or adding bone, bone material, and/or foundation material, installing an implant, repositioning an implant, and the like).
  • the tools may operate with many different force modes relative to the portion of
  • the anchor, a controller, and/or the tool may be provided with a set of sensors for collecting and/or assessing a set of parameters.
  • the anchor helps to reduce wasting energy applied at an interface between the tool and the portion of bone.
  • the anchor may aid in force transfer in some cases.
  • An implementation of the anchor may include essentially a passive static structure. In other instances, the anchor may include dynamic adjustable elements.
  • An embodiment of the present invention may include a substitute for a surgical robot or other robotic system by providing a smart three-dimensional processing tool that may include relativistic navigational and force sensing elements to reference processings to the patient and become relatively free of an absolute reference system calibrated to a space or environment, such as a particular operating room.
  • a smart three-dimensional processing tool may include relativistic navigational and force sensing elements to reference processings to the patient and become relatively free of an absolute reference system calibrated to a space or environment, such as a particular operating room.
  • use of inertial measurement units and force sensors may allow for an embodiment that is simple and efficient.
  • any of the embodiments described herein may be used alone or together with one another in any combination.
  • Inventions encompassed within this specification may also include embodiments that are only partially mentioned or alluded to or are not mentioned or alluded to at all in this brief summary or in the abstract.
  • the embodiments of the invention do not necessarily address any of these deficiencies.
  • different embodiments of the invention may address different deficiencies that may be discussed in the specification. Some embodiments may only partially address some deficiencies or just one deficiency that may be discussed in the specification, and some embodiments may not address any of these deficiencies.
  • FIG. 1-FIG. 4 illustrate a time-lapse series of constant velocity relative motion between a prosthesis engaged by an installation system and an installation site for the prosthesis.
  • FIG. 1 illustrates an initial orientation of the installation system and the installation site
  • FIG. 2 illustrates a first period after an initiation of a constant velocity installation process
  • FIG. 3 illustrates a second period after the initiation of the constant velocity installation process
  • FIG. 4 illustrates a third period after Initiation of the constant velocity installation process in which the prosthesis has been installed without meaningful acceleration or impacts;
  • FIG. 5-FIG. 10 illustrate embodiments including installation of a prosthesis, including installation into living bone
  • FIG. 5 illustrates an embodiment of the present invention for a sliding impact device
  • FIG. 6 illustrates a lengthwise cross-section of the embodiment illustrated in FIG. 5 including an attachment of a navigation device
  • FIG. 7 illustrates a cockup mechanical gun embodiment, an alternative embodiment to the sliding impact device illustrated in FIG. 5 and FIG. 6;
  • FIG. 8 illustrates an alternative embodiment to the devices of FIG. 5-7 including a robotic structure
  • FIG. 9 illustrates an alternative embodiment to the devices of FIG. 5-8 including a pressure sensor to provide feedback
  • FIG. 10 illustrates an alternative embodiment to the feedback system of FIG. 9 including a sound sensor to provide feedback for the embodiments of FIG. 5-9;
  • FIG. 11-FIG. 14 illustrate prosthesis assembly embodiments including use of variations of the prosthesis installation embodiments of FIG. 5-FIG. 10, such as may be used to reduce a risk of trunnionosis;
  • FIG. 11 illustrates a modular prosthesis and assembly tools
  • FIG. 12 illustrates a femoral head to be assembled onto a trunnion attached to a femoral stem
  • FIG. 13 illustrates alignment of an installation device with the femoral head for properly aligned impaction onto the trunnion, such as an embodiment of FIG. 1-FIG. 6 adapted for this application;
  • FIG. 14 illustrates use of a modified vibratory system for assembly of the modular prosthesis
  • FIG. 15-FIG. 16 illustrate an improvement to site preparation for an installation of a prosthesis
  • FIG. 15 illustrates an environment in which a prosthesis is installed highlighting problem with site preparation
  • FIG. 16 illustrates an alignment system for preparation and installation of a prosthesis
  • FIG. 17 illustrates modified surgical devices incorporating vibratory energy as at least an aid to mechanical preparation
  • FIG. 18 illustrates a first embodiment for a BMD5 tool
  • FIG. 19 illustrates a second embodiment for a BMD5 tool
  • FIG. 20 illustrates a third embodiment for a BMD5 tool
  • FIG. 21 through FIG. FIG. 37 illustrate a particular implementation of a mechanical alignment system for use with an embodiment of a BMD5 tool
  • FIG. 21 illustrates a side view of a prosthetic body to be mechanically joined to an installable prosthetic head
  • FIG. 22 and FIG. 23 illustrate a set of views of a prosthetic head to be installed on the prosthetic body of FIG. 21;
  • FIG 22 illustrates a top view of the prosthetic head
  • FIG. 23 illustrates a side view of the prosthetic head
  • FIG. 24 through FIG. 27 illustrate a set of views for an anvil for imparting an assembly force to the prosthetic head
  • FIG. 24 illustrates a side view of the anvil
  • FIG. 25 illustrates a top view of the anvil
  • FIG. 26 illustrates a bottom view of the anvil; and [0066] FIG. 27 illustrates a sectional view through the anvil;
  • FIG. 28 through FIG. 32 illustrate a set of views of a two-part clamp for securing the anvil to the prosthetic head
  • FIG. 28 illustrates a side view of the two-part clamp
  • FIG. 29 illustrates a top view of the two-part clamp
  • FIG. 30 illustrates a bottom view of the two-part clamp
  • FIG. 31 illustrates a sectional view through the two-part clamp
  • FIG. 32 illustrates an enlarged view of FIG. 31 ;
  • FIG. 33 through FIG. 35 illustrate a set of views of a clamp for attachment to the prosthetic body and apply an aligned assembly force to the prosthetic head by use of the two-part clamp;
  • FIG. 33 illustrates a top view of the clamp
  • FIG. 34 illustrates an end view of the clamp
  • FIG. 35 illustrates a side view of the clamp
  • FIG. 36 illustrates a stackup view for the mechanical alignment system shown securing, aligning, and applying an assembly force to the prosthetic head to install it onto the prosthetic body;
  • FIG. 37 illustrates a representative manual torque wrench which may be used with the system illustrated in FIG. 36 to apply a predetermined assembly force to produce a desired mechanical join of the prosthetic head onto the prosthetic body;
  • FIG. 38 illustrates a side view of an alternative prosthetic body to be mechanically joined to an installable prosthetic head
  • FIG. 39 - FIG. 42 illustrate a set of standard orthopedic bone preparation tools
  • FIG. 39 illustrates a perspective view of a powered bone saw
  • FIG. 40 illustrates a broach attachment for a powered reciprocating bone preparation tool
  • FIG. 41 illustrates a hand-operated reamer
  • FIG. 42 illustrates a set of bone preparation burrs
  • FIG. 43 illustrates a side view of a first set of components for a conventional bone preparation process
  • FIG. 44 illustrates a side view of a second set of components for a three-dimensional bone sculpting process that may be enabled by some embodiments of the present invention.
  • FIG. 45 illustrates a plan diagram of a smart tool robot.
  • Embodiments of the present invention provide a system and method for improving installation of a prosthesis, particularly an acetabular cup.
  • a prosthesis particularly an acetabular cup.
  • the following description is presented to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements.
  • the term “or” includes “and/or” and the term “and/or” includes any and all combinations of one or more of the associated listed items. Expressions such as “at least one of,” when preceding a list of elements, modify the entire list of elements and do not modify the individual elements of the list.
  • a set refers to a collection of one or more objects.
  • a set of objects can include a single object or multiple objects.
  • Objects of a set also can be referred to as members of the set.
  • Objects of a set can be the same or different.
  • objects of a set can share one or more common properties.
  • adjacent refers to being near or adjoining. Adjacent objects can be spaced apart from one another or can be in actual or direct contact with one another. In some instances, adjacent objects can be coupled to one another or can be formed integrally with one another.
  • connect refers to a direct attachment or link. Connected objects have no or no substantial intermediary object or set of objects, as the context indicates.
  • Coupled objects can be directly connected to one another or can be indirectly connected to one another, such as via an intermediary set of objects.
  • the use of the term “about” applies to all numeric values, whether or not explicitly indicated. This term generally refers to a range of numbers that one of ordinary skill in the art would consider as a reasonable amount of deviation to the recited numeric values (i.e., having the equivalent function or result). For example, this term can be construed as including a deviation of +10 percent of the given numeric value provided such a deviation does not alter the end function or result of the value. Therefore, a value of about 1% can be construed to be a range from 0.9% to 1.1%.
  • the terms “substantially” and “substantial” refer to a considerable degree or extent. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation, such as accounting for typical tolerance levels or variability of the embodiments described herein.
  • a size of an object that is spherical can refer to a diameter of the object.
  • a size of the non-spherical object can refer to a diameter of a corresponding spherical object, where the corresponding spherical object exhibits or has a particular set of derivable or measurable properties that are substantially the same as those of the non-spherical object.
  • a size of a non-spherical object can refer to a diameter of a corresponding spherical object that exhibits light scattering or other properties that are substantially the same as those of the non-spherical object.
  • a size of a non-spherical object can refer to an average of various orthogonal dimensions of the object.
  • a size of an object that is a spheroidal can refer to an average of a major axis and a minor axis of the object.
  • the objects can have a distribution of sizes around the particular size.
  • a size of a set of objects can refer to a typical size of a distribution of sizes, such as an average size, a median size, or a peak size.
  • FIG. 1-FIG. 4 illustrate a time-lapse series of constant velocity relative motion between a prosthesis P, engaged by an installation system 100, and an installation site (S) for the prosthesis P.
  • prosthesis P will be described as an acetabular cup to be installed into the installation site S - a prepared cavity in an acetabulum 110 as may be part of a hip replacement procedure.
  • System 100 includes a fixation apparatus 105 that fixes relative motion between a tool 115 mechanically communicated to prosthesis P and installation site S.
  • fixation apparatus 105 fixes relative motion between a tool 115 mechanically communicated to prosthesis P and installation site S.
  • there may be several ways to achieve this mechanical linkage for example one or more Shantz screws fixed in the pelvic bone may secure tool 115 in the desired relative position.
  • installation system 100 moves prosthesis P into placement in installation site S with constant relative motion. There may be several mechanisms by which this constant relative motion is achieved. The specifics of which may impact the manner by which fixation apparatus 105 is configured and implemented.
  • the term "constant relative motion" is not to require that the relative motion be necessarily uniform, though in some implementations uniform constant relative motion may be preferred.
  • system 100 places prosthesis P in motion relative to installation site S and motion continues once started (hence constant motion) until the desired installation parameters are achieved (e.g., complete seating of prosthesis P in installation site S).
  • Fixation apparatus 105 may be implemented in many different formats and modes.
  • apparatus 105 may consist almost exclusively of fixed static elements that secure, constrain, and/or fix tool 115 to a portion of bone or active foundation to be processed (e.g., acetabulum 110).
  • apparatus 110 may include a more complex dynamically adjustable structure for interacting with tool 115.
  • Some functions described herein associated with apparatus 105, bone 110, and/or tool 115 may be shared, distributed, reallocated to some or others of the devices. For example in some
  • tool 115 and/or apparatus 105 may include force generators, such as to impart an implanting force to an implant.
  • Apparatus 105 helps to improve the implanting (and other processings) in a number of possible ways as described herein.
  • Tool 115 may include a robotic system or other medical device (for example, one of the Behzadi Medical Devices (BMDs) described in an incorporated application).
  • BMDs Behzadi Medical Devices
  • FIG. 1 illustrates an initial orientation of installation system 100 and installation site S
  • FIG. 2 illustrates a first period after an initiation of a constant velocity installation process
  • FIG. 3 illustrates a second period after the initiation of the constant velocity installation process
  • FIG. 4 illustrates a third period after Initiation of the constant velocity installation process in which prosthesis P has been installed without meaningful acceleration or impacts.
  • acceleration is a change of velocity with respect to time.
  • any non-uniform constant motion may be considered to have some acceleration as the direction or speed changes.
  • any acceleration does not produce impactful-type forces on prosthesis P or installation site S, such an embodiment may include the present invention.
  • the constant motion varies no more than a predetermined amount once started, for example, relative speed is maintained within a 25%, within 10%, within 5%, and within 1% variation.
  • relative motion which may include one or both of prosthesis P and installation site S being in motion, or being stationary, at any given time. Which element moves, and in which direction, is less important than that the relative motion be uniform.
  • the robotic arm inserts one or more Schantz screws into pelvis around the periphery of the acetabular rim, and in that way, stabilizes the pelvis' s position in relation to the robotic end effector arm (or a stabilized BMD tool).
  • the robotic arm (or the stabilized BMD tool) can then push the cup into the pelvis at constant velocity without impacts, dealing only with the coefficient of kinetic friction once the motion has started, and hence (the resistive forces of kinetic friction regime).
  • the resistive force (FR) that are encountered may be up to 30% to 50% lower, than an alternative where the cup would be inserted with impulsive forces.
  • Embodiments of the present invention may include one of more solutions to the above problems.
  • the incorporated US Patent No. 9,168,154 includes a description of several embodiments, sometimes referred to herein as a BMD3 device, some of which illustrate a principle for breaking down large forces associated with the discrete blows of a mallet into a series of small taps, which in turn perform similarly in a stepwise fashion while being more efficient and safer.
  • the BMD3 device produces the same displacement of the implant without the need for the large forces from the repeated impacts from the mallet.
  • the BMD3 device may allow modulation of force required for cup insertion based on bone density, cup geometry, and surface roughness.
  • a use of the BMD3 device may result in the acetabulum experiencing less stress and deformation and the implant may experience a significantly smoother sinking pattern into the acetabulum during installation.
  • Some embodiments of the BMD3 device may provide a superior approach to these problems, however, described herein are two problems that can be approached separately and with more basic methods as an alternative to, or in addition to, a BMD3 device.
  • An issue of undesirable torques and moment arms is primarily related to the primitive method currently used by surgeons, which involves manually banging the mallet on the impaction plate. The amount of force utilized in this process is also non-standardized and somewhat out of control.
  • an embodiment of the present invention may include a simple mechanical solution as an alternative to some BMD3 devices, which can be utilized by the surgeon's hand or by a robotic machine.
  • a direction of the impact may be directed or focused by any number of standard techniques (e.g., A-frame, C-arm or navigation system). Elsewhere described herein is a refinement of this process by considering directionality in the reaming process, in contrast to only considering it just prior to impaction.
  • a sledgehammer device or a structure e.g., hollow cylindrical mass
  • Device 500 includes a moveable hammer 505 sliding axially and freely along a rod 510.
  • Rod 510 includes a proximal stop 515 and distal stop 520. These stops that may be integrated into rod 510 to allow transference of force to rod 510 when hammer 505 strikes distal stop 520.
  • device 500 includes an attachment system 615 for a prosthesis 620.
  • attachment system 615 may include a complementary threaded structure that screws into threaded cavity 625. The illustrated design of device 500 allows only a perfect axial force to be imparted.
  • a longitudinal axis 630 extends through the ends of rod 510.
  • Attachment system 615 aligns prosthesis 620 to axis 630 when rod 510 is coupled to threaded cavity 625.
  • An apex of prosthesis 620 (when it generally defines a hollow semispherical shell) supports a structure that defines threaded cavity 625 and that structure may define a plane 635 that may be tangent to the apex, with plane 635 about perpendicular to axis 630 when rod 510 engages prosthesis 620.
  • Operation of device 500 is designed to deliver only axial (e.g., aligned with axis 630 and thus non- torqueing) forces to prosthesis 620.
  • Other embodiments illustrated in FIG. 7-FIG. 10 may be similarly configured.
  • FIG. 7 illustrates a cockup mechanical gun 700 embodiment, an alternative embodiment to the sliding impact device illustrated in FIG. 5 and FIG. 6.
  • An alternate embodiment includes cockup mechanical gun 700 that uses the potential energy of a cocked up spring 705 to create an axially aligned impaction force.
  • Hammer 505 is drawn back and spring 705 is locked until an operator actuates a trigger 710 to release spring 705 and drive hammer 505 along rod 510 to strike distal stop 520 and transfer an axially aligned impacting force to prosthesis 620.
  • FIG. 8 illustrates an alternative robotic device 800 embodiment to the devices of FIG. 5-7 including a robotic control structure 805.
  • device 500 and/or gun 700 may be mounted with robot control structure 805 and the co-axial impacts may be delivered mechanically by a robotic tool using pneumatic or electric energy.
  • FIG. 9 illustrates an alternative embodiment 900 to the devices of FIG. 5-8 including a pressure sensor 905 to provide feedback during installation.
  • a pressure sensor 905 to provide feedback during installation.
  • the surgeon has no indication of how much force is being imparted onto the implant and/or the implant site (e.g., the pelvis).
  • Laboratory tests may be done to estimate what range of force should be utilized in certain age groups (as a rough guide) and then fashioning a device 900, for example a modified sledgehammer 500 or cockup gun 700 to produce just the right amount of force.
  • the surgeon may use up to 2000N to 3000N of force to impact a cup into the acetabular cavity.
  • device 900 includes a stopgap mechanism.
  • Some embodiments of the BMD3 device have already described the application of a sensor in the body of the impaction rod.
  • Device 900 includes sensing system/assembly 905 embedded in device 900, for example proximate rod 510 near distal end 610, and used to provide valuable feedback information to the surgeon.
  • Pressure sensor 905 can let the surgeon know when the pressures seems to have
  • the disclosure here relates to a pressure sensor provided not to characterize the installation pulse pattern but to provide an in situ feedback mechanism to the surgeon as to a status of the installation, such as to reduce a risk of fracturing the installation site. Some embodiments may also employ this pressure sensor for multiple purposes including
  • characterization of an applied pulse pattern such as, for example, when the device includes automated control of an impacting engine coupled to the hammer.
  • Other embodiments of this invention may dispose the sensor or sensor reading system within a handle or housing of the device rather than in the central rod or shaft.
  • FIG. 10 illustrates an alternative device 1000 embodiment to the feedback system of FIG. 9 including a sound sensor 1005 to provide feedback for the embodiments of FIG. 5-9.
  • Sound sensor 1005 either attached or coupled to rod 510 or otherwise disposed separately in the operating room. Sound sensor system/assembly 1005 may be used in lieu of, or in addition to, pressure sensor system/assembly 905 illustrated in FIG. 9.
  • FIG. 11-FIG. 14 illustrate prosthesis assembly embodiments including use of variations of the prosthesis installation embodiments of FIG. 5-FIG. 10, such as may be used to reduce a risk of trunnionosis or for other advantage.
  • FIG. 11 illustrates a modular prosthesis 1100 and assembly tool 1105.
  • Prosthesis 1100 includes a head 1110 and a trunnion taper 1115 at an end of a stem 1120 (e.g., a femoral stem for supporting a ball head to fit within an acetabular cup used in a total hip replacement procedure).
  • a stem 1120 e.g., a femoral stem for supporting a ball head to fit within an acetabular cup used in a total hip replacement procedure.
  • the surgeon assembles prosthesis 1100 by using tool 1105 which may include an impact rod 1125 attached to a head coupler 1130.
  • the surgeon uses tool 1105 to drive head 1110 onto trunnion taper 1115 which conventionally includes a free mallet striking tool 1105.
  • trunnion taper 1115 which conventionally includes a free mallet striking tool 1105.
  • Such a procedure may be prone to the similar problems as installation of a prosthesis into an implant site, namely application of off-axis torqueing forces and an uncertainty of applied force and completion of assembly.
  • FIG. 12 illustrates a femoral head 1205, a variation of head 1110 illustrated in FIG. 11, to be assembled onto trunnion taper 1115 that is coupled to femoral stem 1120.
  • a center dot 1210 may be placed on femoral (or humeral) head 1205 to be impacted using tool 1105.
  • FIG. 13 illustrates alignment of an installation device 1300, a variation of any of devices 500-1000, with femoral head 1205 for properly aligned impaction onto trunnion taper 1115, such as an embodiment of FIG. 5-FIG. 10 adapted for this application.
  • Such adaptation may include, for example, an axial channel 1310 to view dot 1210, and align force transference, prior to operation of hammer 505.
  • Device 1300 includes a sledgehammer 1315 and a cock-up spring to drive sledgehammer 1315.
  • a slot 1325 allows an operator to visualize a centering mark 1330.
  • a spring- loading 1335 may be used to operate a device.
  • Dot 1210 can be aligned with an impactor/device/gun. Once axial alignment, such as through the sight channel, has been confirmed, a sledgehammer, a cockup gun, or other similar device can bang the impactor onto femoral (humeral) head 1205 to impact it on trunnion taper 1115. The co-axiality of the head and the device can be confirmed visually (for example, through a hollow cylinder that comprises a center shaft of the device) or with a variety of electronic and laser methods.
  • FIG. 14 illustrates use of a modified vibratory system 1400, a variation of installation device 1300 for assembly of the modular prosthesis illustrated in FIG. 11.
  • a variation of the BMD3 device can be used to insert the femoral and humeral heads 1110 onto trunnion taper 1115.
  • a version of the BMD3 device where femoral head 1110 is grasped by a "vibrating gun" and introduced methodically and incrementally onto trunnion taper 1115.
  • FIG. 15-FIG. 16 illustrate an improvement to site 1500 preparation for an installation of a prosthesis 1505.
  • FIG. 15 illustrates a site 1500 in which prosthesis 1505 is installed highlighting a problem with site preparation for a prosthesis installation procedure having variable density bone (line thickness/separation distance reflecting variable bone density) of acetabulum 1510.
  • Some processings e.g., reaming or other cutting
  • Altered path 1515 is shifted, such as away from the dense bone towards the less dense bone.
  • FIG. 16 illustrates an alignment system 1600 for preparation and installation of a prosthesis to help address/minimize this effect.
  • a first step that can be taken is to include
  • the reamer handle Before the surgeon begins to ream the acetabulum, the reamer handle should be held, with an A-frame attached, in such a way to contemplate the final position of the reamer and hence the implant, (e.g., hold the reamer in 40 degree abduction and 20 degree anteversion reaming is started). This step could also be accomplished with navigation or fluoroscopy. The surgeon could, for example, immediately mark this position on a screen or the wall in the operating room as described below and as illustrated in FIG. 16. After the anticipated position of the reamer is marked, the surgeon can do whatever aspect of reaming that needs to be done.
  • the first reaming usually requires medialization in which the reamer is directed quite vertically to ream in to the pulvinar. Typically three or four reamings are done.
  • the acetabular cavity is medialized.
  • the other reamings function to get to the subchondral bone in the periphery of the acetabulum.
  • One solution may be that after each reaming, the reamer handle be held in the final anticipated position of the implant. In some cases it may be difficult to have an A-frame attached to every reamer and to estimate the same position of the reamer in the operating space accurately with the A-frame.
  • a first reference system 1605 for example a laser pointer.
  • This laser pointer 1605 will project a spot 1610 either on a wall or on a screen 1615, a known distance from the operating room table.
  • That spot 1610 on screen 1615 (or on the screen) is then marked with another reference system 1620, for example a second independent laser pointer that sits on a steady stand in the operating room.
  • the surgeon knows that the device attached to the handle has the desired orientation.
  • the laser pointer at the proximal end of the reamer handle projects a spot on the wall or screen. That spot is marked with the second stationary laser, and held for the duration of the case. All subsequent reamings will therefore not require an A-frame to get a sense of the proper alignment and direction of the reamer.
  • the surgeon assures that no matter how he moves the reamer handle in the process of reaming of the acetabulum, that the reaming finishes with the reamer handle (laser pointer) pointing to the spot on the wall/screen.
  • FIG. 17 illustrates modified surgical devices 1700 incorporating vibratory energy as at least an aid to mechanical preparation.
  • Another concept to address a problem associated with non-concentric reaming of the acetabulum caused by variable densities of the bone and the uncovering of the reamer.
  • the same carpenter has to cut through a construct that is made out of wood, air, and cement. The carpenter does not know anything about the variable densities of this construct.
  • Also available is a second saw that cuts just as effectively through cement as wood. Which of these saws would improve a chance of producing a more precise cut?
  • Proposed is a mixing of ultrasonic energy with the standard oscillating saw and the standard reamer.
  • any oscillating equipment used in orthopedics including the saw, reamer, drill, and the like may be made more precise in its ability to cut and prepare bone with the addition of ultrasonic energy. This may feel dangerous and counterintuitive to some, however, the surgeon typically applies a moderate amount of manual pressure to the saw and reamers, without being aware, which occasionally causes tremendous skiving , bending and eccentric reaming.
  • An instrument that does not requires the surgeon's manual force maybe significantly safer and as well as more precise and effective.
  • a further option includes disposition of a sensor in the shaft of the ultrasonic reamers and saws so that the surgeon can ascertain when hard versus soft bone is being cut, adding a measure of safety by providing a visual numerical feedback as to the amount of pressure being utilized.
  • This improvement (the ability to cut hard and soft bone with equal efficacy) will have tremendous implications in orthopedic surgery.
  • the acetabular cavity is prepared more precisely, with significantly lower tolerances, especially when directionality is observed, the acetabular implant (cup) may more easily follow the intended sinking path.
  • embodiments of the present invention may include aspects of resistive force measurement, resistive force curves, and BMD tools that include force sensing, such as described in US Patent Application No. 15/234,782 filed 11 August 2016 which claims benefit of the incorporated '434 patent application as well as US Patent Application No. 62/355,657 and US Patent Application No. 62/353,024 and also described in US Patent Application No. 15/284,091, all of which are hereby expressly incorporated by reference thereto in their entireties for all purposes.
  • These applications include a description of a resistive force for insertion of a hemispherical acetabular cup into an under reamed cavity.
  • This resistive force is sometimes referred to as the FR curve, defining a "cup print" for the insertion parameters.
  • This resistive force has been described as being variable with three distinct sections. It has a profile that may be described as an "exponential curve". There is an identification of an early section/part of this FR curve where poor insertion and pull out forces exist. There is an identification of a middle section (a sweet spot) on this FR curve where good insertion and extraction forces are achieved. And, finally, the discussion describes that using larger forces beyond the sweet spot provide little additional benefit to the strength of fixation, and may increase a risk of fracture.
  • this FR curve may represent a dangerous peak such as Mount Everest having five base camps.
  • an orthopedic surgeon should be content to stop at base camp 3 or 4, and perhaps should not attempt to summit, when trying to obtain press fit fixation of the cup in an under-reamed cavity. This phenomena has been described in association with BMD3 and BMD4.
  • Corrosion has been associated with clinical complications, such as elevated metal ion levels, persistent pain, tissue damage, and early implant failure.
  • the force is delivered by a surgeon using a mallet. There is no standardization of magnitude of force. There is no guidance as to how much force needs to be delivered. The medical device companies have not done In Vitro studies to determine how much force to deliver for a good seal. There is no a priori information as to what type of force produces a desired "cold weld", which appears to be what we need to accomplish strong fixation with no micro-motion.
  • a head may include a flat edge that allows it to sit flat on a table.
  • a "head holder” may grasp the head in a 'normal' fashion on the flat edges.
  • On an opposite side of the head holder a center axis point may be created, which allows ONLY central axis application of force.
  • the force as will be described can be delivered dynamically through controlled impaction as with BMD4 technique (e.g., various slide hammer configurations), or vibratory insertion as with BMD3 techniques or with Constant insertion (to allow the system to mostly deal with friction (e.g., a coefficient of kinetic friction Uk).
  • BMD4 technique e.g., various slide hammer configurations
  • Constant insertion to allow the system to mostly deal with friction (e.g., a coefficient of kinetic friction Uk).
  • the prosthesis may have either indentations, holes, or ridges created in it to allow an insertion apparatus (BMD5) to purchase and grasp the prosthesis. This is a way to avoid unnecessary loss and waste of kinetic energy.
  • a force sensor/torque wrench/strain gauge within the tool measures the force experienced within the tool/head/trunnion/prosthesis complex.
  • An amount (magnitude) of force required to obtain a perfect weld can be determined in vitro.
  • the force can be delivered with controlled impaction, vibratory insertion, or constant insertion.
  • the force sensor may, in some implementations, act much like a torque wrench (possibly) stopping the application of the perfectly tuned force (both magnitude and direction) when a cold weld is obtained. Little to no dissipation of force/energy may occur in this system.
  • the inconsistencies that are introduced by the surgeon and the mallet with current techniques are eliminated entirely. Since the surgeon is told in advance how much force to deliver and given the proper tool to accomplish this job, it is impossible to deliver less than required force. Since the tool only applies perfectly axial force, no canting can occur. Since the head and trunnion are now coupled/constrained in one physical system, wasting of kinetic energy will reduced or eliminated.
  • the insertion of the head onto the trunnion is now done with a technologically intelligent and reliable system.
  • FIG. 18-FIG. 20 an embodiment of a BMD5 tool will be used to help assemble a modular prosthesis. This is similar to the discussion of FIG. 11.
  • modular prosthesis 1100 was assembled using assembly tool 1105 while in these discussions, a BMD5 tool replaces tool 1105 (with an optional modification to prosthesis 1100).
  • Prosthesis 1100 includes a head 1110 and a trunnion taper 1115 at an end of a stem 1120 (e.g., a femoral stem for supporting a ball head to fit within an acetabular cup used in a total hip replacement procedure).
  • the surgeon assembles prosthesis 1100 by using a BMD5 tool. The surgeon uses the BMD5 tool to drive, and cold weld, head 1110 onto trunnion taper 1115.
  • FIG. 18 illustrates a first embodiment for a BMD5 tool 1800 used in cooperation with assembly of modular prosthesis 1100 to install head 1110 onto trunnion taper 1115 at an end of stem 1120.
  • Prosthesis 1100 is modified to include a grip structure 1805 (e.g., an indentation, hole, cavity, aperture, and the like) to allow engagement of a retention structure (e.g., a claw, grasper, gripper, and the like - represented by G) coupled to both tool 1800 and to prosthesis 1100.
  • a grip structure 1805 may be used to reduce or eliminate wasting of kinetic energy during assembly and welding of head 1110 onto taper 1115.
  • BMD5 tool 1800 includes a head grasper 1810, an in-line force sensor module 1815, a torquer 1820, and torque converter 1825.
  • Head grasper 1810 retains and aligns head 1110 into an optimum installation orientation (e.g., perpendicular/normal) to allow application of force only along an assembly axis 1830 joining, and aligned with, grip structure 1805, head 1110, taper 1115, grasper 1810, module 1815 and torque converter 1825.
  • This alignment allows for only force application only along assembly axis 1830 which prevents/reduces canting.
  • Gripper G is illustrated as being functionally connected to grasper 1810, but could be mechanically communicated to another portion or component of tool 1800. This is a functional representation as there may be several mechanical ways to implement this function, including allowing relative displacement of the grasper and trunnion while maintaining the desired alignment(s).
  • Grasper 1810 is important in positioning (including alignment and relative orientation) of head 1110 and trunnion 1115.
  • Head 1110 includes an aperture, typically
  • Grasper 1810 secures head 1110 for assembly in a very simple and efficient manner that positions, without relative canting, head 1110 and trunnion 1115.
  • Module 1815 may include a torque wrench/strain gauge allowing a surgeon to understand one or more forces in play, such as knowing exactly how much force needs to be, and is being, delivered to obtain perfect cold weld of head 1110 onto taper 1115.
  • Torquer 1820 may include a manual or motorized source of force or torque, such as a torque engine which may include a rotary motor.
  • Torque converter 1825 transforms torque of torquer 1820 into axial-exclusive linear force for module 1815.
  • converter 1825 may include a linear motion converter to alter the rotary force into an axially-aligned linear force.
  • femoral head 1110 may be joined to trunnion taper 1115 using constant insertion. That is, head 1110 is "press-fit" with a constant (but potentially variable) axial force. This is distinguished from application of one or more discrete impacts or impulses onto grasper 1810. Constant insertion strongly implicates Uk (coefficient of kinetic friction) which may be less than a series of discrete impacts that more strongly implicate a coefficient of static friction.
  • stem 1120 is installed into bone and thereafter tool 1800 is used to install head 1110 onto the taper of trunnion 1115 to obtain a sufficient mechanical connection.
  • FIG. 19 illustrates a second embodiment for a BMD5 tool 1900 used in cooperation with assembly of modular prosthesis 1100 to install head 1110 onto trunnion taper 1115 at an end of stem 1120.
  • Tool 1900 varies from tool 1800 in that tool 1900 performs insertion using a vibration profile.
  • the vibration profile is provided by a vibration engine 1905 that may include a rotary motor 1910 coupled to a linear motion converter 1915 to impart a vibration to head grasper 1810 (and then to head 1110) to insert and cold weld head 1110 onto trunnion taper 1115.
  • vibration engine 1905 may include a rotary motor 1910 coupled to a linear motion converter 1915 to impart a vibration to head grasper 1810 (and then to head 1110) to insert and cold weld head 1110 onto trunnion taper 1115.
  • vibration engine 1905 may include a rotary motor 1910 coupled to a linear motion converter 1915 to impart a vibration to head grasper 1810 (and then to head 1110) to insert and
  • tool 1900 may join head 1110 to taper 1115 with a vibratory force (implicating a blend of static and kinetic coefficients of friction - Us and Uk), which may require less force than a series of discrete/dynamic impacts onto head 1110.
  • FIG. 20 illustrates a third embodiment for a BMD5 tool 2000 used in cooperation with assembly of modular prosthesis 1100 to install head 1110 onto trunnion taper 1115 at an end of stem 1120.
  • Tool 2000 varies from tool 1800 in that tool 2000 performs insertion using an impact profile.
  • the impact profile is provided by an impact engine 2005 that may include a slide hammer 2010 having an axially-limited sliding mass to impart a discrete impact onto a shaft 2015 and by that mechanism to head grasper 1810 (and then to head 1110) to insert and cold weld head 1110 onto trunnion taper 1115.
  • impact engine 2005 may include manual, mechanized (e.g., robotic), and semi-mechanized solutions.
  • tool 2000 may join head 1110 to taper 1115 with a series of one or more discrete impacts from impact engine 2005 (implicating predominantly/exclusively static coefficient of friction Us).
  • BMD 5 is a tool that:
  • [0167] Advantageously modifies a femoral prosthesis in such a way to allow a grasp or engagement of the prosthesis by the BMD5 tool. This can be accomplished in a variety of ways: A hole, dent, ridges, and indentations can be created on the prosthesis. The ability to grasp the prosthesis is important in some embodiments in that it prevents, or reduces, waste of kinetic energy.
  • the BMD5 tool may include a "head grasper” which holds the femoral or humeral head in a perpendicular or "normal” fashion. This allows the force of insertion/impaction to be applied perfectly axially, without the risk of "canting".
  • the BMD5 tool has a torque wrench/strain gauge/force sensor of a wide variety of possible types that measures an amount of force applied through the tool/head/trunnion/prosthesis complex.
  • the surgeon will always know exactly how much force is being applied.
  • the amount of force required to obtain a perfect "cold weld” can be predetermined in the laboratory.
  • the surgeon can simply apply the force that is recommended by the medical device company to obtain a perfect cold weld every single time, eliminating all variability that is currently present with application of force with variable surgeon strengths and mallet sizes.
  • BMD5 may include a self-contained system that reduces any wasting of energy. BMD5 may allow for perfect axial delivery of force while providing for quantitative measurement of applied/communicated/transmitted force(s). So stakeholders can rest assured that every step has been taken to obtain a cold weld at the trunnion/head interface. Embodiments of BMD5 may allow a surgeon to cold weld the femoral head onto the trunnion simply, efficiently, and accurately while minimizing risks of improper installation. Some embodiments of BMD5 may include ultrasonic press-fitting, such as described in Csaba LAURENCZY et al., "ULTRASONIC PRESS-FITTING: A NEW ASSEMBLY TECHNIQUE" S. Ratchev (Ed.): IPAS 2014, IFIP AICT 435, pp. 22-29, 2014, hereby expressly incorporated by reference in its entirety for all purposes.
  • FIG. 21 through FIG. FIG. 37 illustrate a particular implementation of a mechanical alignment system for use with an embodiment of a BMD5 tool, such as, for example, those illustrated and/or described herein.
  • FIG. 21 illustrates a side view of a prosthetic body 2100 to be mechanically joined to an installable prosthetic head.
  • Body 2100 includes a stem portion 2105 for insertion into a prepared bone and a taper portion 2110 for mechanical joinder to a selected installable prosthetic head.
  • a center line 2115 is defined as a central axis of taper portion 2110.
  • Taper portion 2110 may include a two-dimensional symmetry along a length of center line 2115.
  • the installable prosthetic head will include a complementary taper cavity that may further match this two-dimensional symmetry over a depth of the taper cavity along a taper cavity center line.
  • Body 2100 may include, as a grip structure, a non-traditional through-hole 2120 centered on center line 2115 proximate taper portion 2110.
  • grip structure 2120 may not be a through hole but may include, for example, laterally opposed divots with each centered on center line 2115.
  • the grip structure may include a conventional non-center line aligned element 2125.
  • An adaptor, jig, or engagement system cooperating with element 2125 may provide a predetermined offset to align such other assembly components with center line 2115.
  • FIG. 22 and FIG. 23 illustrate a set of views of a prosthetic head 2200 to be installed on taper portion 2110 of prosthetic body 2100.
  • FIG 22 illustrates a top view of prosthetic head 2200
  • FIG. 23 illustrates a side view of prosthetic head 2200.
  • Prosthetic head 2200 defines an outer spherical surface 2205, at least a hemisphere, and further includes a planar face 2310, offset from but generally parallel to a diameter of the spherical portion of head 2200.
  • An aperture is defined in planar face 2310, this aperture provides an opening into a taper cavity 2215 disposed within prosthetic head 2200.
  • Taper cavity 2215 is designed to mate and engage with taper portion 2110 and in this sense is referred to herein as being complementary.
  • Taper cavity 2215 also defines a taper cavity center line 2220 also having a two-dimensional symmetry along a depth of taper cavity 2215, and in some cases taper cavity center line 2220 is perpendicular to planar face 2310.
  • An optional feature includes a marking, for example, a laser etch or other patterning modality, that applies a visible set of "cross hairs" 2225 centered on taper cavity center line 2220.
  • a goal of the supporting structures of some embodiments of the present invention may include configuring alignment of center line 2115 with center line 2220, maintaining that alignment while taper portion 2110 is mechanically joined with taper cavity 2215, and in some cases monitoring a magnitude of applied assembly forces to achieve a desired mechanical join (e.g., a cold weld or the like).
  • a desired mechanical join e.g., a cold weld or the like.
  • cross sections along a length of the center lines for both taper portion 2110 and taper cavity 2215 are circular, other cross sectional shapes may be employed without departing from the present invention.
  • FIG. 24 through FIG. 27 illustrate a set of views for an anvil 2400 intended to impart an assembly force to prosthetic head 2200 relative to prosthetic body 2100.
  • FIG. 24 illustrates a side view of anvil 2400
  • FIG. 25 illustrates a top view of anvil 2400
  • FIG. 26 illustrates a bottom view of anvil 2400
  • FIG. 27 illustrates a sectional view through anvil 2400 at A-A of FIG. 24.
  • Anvil 2400 includes a solid body 2405 having a circumferential channel 2410 extending completely around an outside of a lateral sidewall of body 2405.
  • Body 2405 includes a top face 2415 and a bottom face 2420 spaced apart from top face 2415 by the sidewall.
  • a spherical sectional depression 2425 is defined in top face 2415. Depression 2425 is complementary to outer spherical surface 2205. Depression 2425 has a depth to position the planar face of prosthetic head 2200 into a predetermined relationship with top face 2415. In some instances, bottom face 2420 may define a tap or aperture 2605 that is centered at a longitudinal axis 2705 of body 2405 that extends through top face 2415 and bottom face 2420 and automatically aligns with taper cavity center line 2220 when prosthetic head 2200 is installed into mating depression 2425.
  • Bottom surface 2420 supports an anvil axis interaction structure, such as tap or aperture 2605 and/or other structure, which may be used for visual confirmation of axial alignment with indicia 2220, or may be used for receipt of a force applicator, or some additional or other interaction with anvil 2400.
  • anvil axis interaction structure such as tap or aperture 2605 and/or other structure, which may be used for visual confirmation of axial alignment with indicia 2220, or may be used for receipt of a force applicator, or some additional or other interaction with anvil 2400.
  • aperture 2605 may extend from bottom surface 2420 into depression 2425.
  • prosthetic head is further provided with optional cross hairs 2225, it is possible to confirm alignment of axis 2705 with center line 2220 when cross hairs 2225 are visible in aperture 2605.
  • FIG. 28 through FIG. 32 illustrate a set of views of a multi-part adaptor 2800 for securing anvil 2400 to prosthetic head 2200.
  • FIG. 28 illustrates a side view of multi-part adaptor 2800
  • FIG. 29 illustrates a top view of multi-part adaptor 2800
  • FIG. 30 illustrates a bottom view of multi-part adaptor 2800
  • FIG. 31 illustrates a sectional view through multi-part adaptor 2800
  • FIG. 32 illustrates an enlarged view of FIG. 31.
  • multi-part adaptor 2800 includes two half-shells (half-shell 2805 and half-shell 2810, each half-shell a mirror image of the other) though other configurations may provide for a different number of parts.
  • Adaptor 2800 defines a top face 2815 and a bottom opening 2820. Top face 2815 defines an aperture 2905 for receipt of taper portion 2110 when prosthetic head 2200 is installed into depression 2424 of anvil 2400 and both head 2200 and anvil 2400 are installed into cavity 3105.
  • Interior portions of the walls of adaptor 2800 further define an interior circumferential ledge 3110 that is designed to mate to circumferential channel 2410 when adaptor 2800 secures anvil 2400 and head 2200.
  • a distance from ledge 3110 to top face 2815 is based upon a height of the planar face of head 2200 above depression 2424 when head 2200 is installed in anvil 2400 with axis 2705 aligned with center line 2225. By matching the distance to the height, top face 2815 will automatically align center line 2225 with axis 2705 when the half-shells are closed down on head 2200 and anvil 2400.
  • aperture 2905 in top face 2815 may be formed with sloped edges to match an angle of taper portion 2110.
  • adaptor 2800 may be configured to a particular one size of prosthetic head 2200.
  • a different adaptor 2800 may be used and in some embodiments, this is the only modification that need be made to the system to accommodate differently sized heads.
  • different sized bodies may be matched to different sized heads by only varying adaptor 2800 in appropriate fashion.
  • FIG. 33 through FIG. 35 illustrate a set of views of a clamp 3300 for attachment to prosthetic body 2100 and apply an aligned assembly force to prosthetic head 2200 by use of the multi-part adaptor 2800.
  • FIG. 33 illustrates a top view of clamp 3300
  • FIG. 34 illustrates an end view of clamp 3300
  • FIG. 35 illustrates a side view of clamp 3300.
  • Clamp 3300 includes a "U- shaped" body 3305 having a first leg 3310, a second leg 3315, and a bridge 3320 coupled to each leg. A distal end of each leg defines an aperture 3325 that are aligned with each other.
  • Bridge 3320 defines a force application structure 3330 for allowing an assembly force to be transferred from outside of clamp 3300 to a location disposed between the legs.
  • structure 3330 includes a tapped/threaded interior surface to allow a complementary threaded bolt to pass into the location.
  • FIG. 35 illustrates that in this implementation, structure 3330 is aligned (e.g., coplanar) with apertures 3325.
  • the transfer structure may need to be adapted accordingly to accommodate the particular assembly force in use.
  • a simple aperture may be used and other cases clamp 3300 may be part of a robotic system, among other variations.
  • FIG. 36 illustrates a stackup view for a mechanical alignment system 3600 shown securing, aligning, and applying an assembly force F to prosthetic head 2200 to install it onto prosthetic taper 2110.
  • a pin 3605 is illustrated that is passed through aligned apertures 3325 and structure 2120 which aligns to center line 2115 and secures the components to prosthetic body 2100.
  • a representative assembly force F is applied by use of a screw 3610 threaded through structure 3330.
  • a pad 3615 at a distal end of screw 3610 contacts anvil 2400 and helps to distribute assembly force F when applied against the assembly including head 2200, anvil 2400, and adaptor 2800.
  • Assembly force F, applied on a force application axis 3620 is automatically aligned with center line 2115 as is the taper cavity of head 2200.
  • Assembly force F causes head 2200 and taper portion 2110 to join together without tilting, canting, or off-axis torqueing impacts, such as is often applied from a mallet.
  • FIG. 37 illustrates a representative manual torque wrench 3700 which may be used with the system illustrated in FIG. 36 to apply a predetermined assembly force, or assembly force profile (e.g., Force F) to produce a desired mechanical join of prosthetic head 2200 onto prosthetic body 2100.
  • assembly force profile e.g., Force F
  • FIG. 38 illustrates a side view of an alternative prosthetic body 3800 to be
  • Body 3800 includes a stem portion 3805 for insertion into a prepared bone and a modular taper portion 3810 for mechanical joinder to selected installable prosthetic head 2200.
  • a center line 2115 is defined as a central axis of modular taper portion 2110.
  • Modular taper portion 2110 may include a two-dimensional symmetry along a length of center line 2115.
  • Installable prosthetic head 2200 will include a complementary taper cavity that may further match this two-dimensional symmetry over a depth of the taper cavity along a taper cavity center line.
  • Body 3800 may include, as a grip structure, a non-traditional through-hole 3815 (or detent/depression/extension/pin or other physical structure centered on center line 2115.
  • grip structure 3815 may not be a through hole on center line 2115 but may include, for example, laterally opposed divots with each centered on center line 2115.
  • the grip structure may include a conventional non-center line aligned element 2125 which may have optionally been provided for removal of body 3800 when installed.
  • An adaptor, jig, or engagement system cooperating with element 2125 may provide a predetermined offset to align such other assembly components with center line 2115.
  • Differences between body 3800 as compared to body 2100 may include one or more of the following possible elements. Illustrated in FIG. 38 is use of modular taper portion 3810 in which the modular prosthesis may include three interchangeable elements: stem, trunnion taper, and head (FIG. 38) as compared to two interchangeable elements: integrated stem/trunnion and head (FIG. 21).
  • Modular trunnion taper 3810 may be a separate element that includes taper portion 3810 coupled to a trunnion extension 3820.
  • Trunnion extension 3820 is designed to be inserted into and received and secured by a complementary trunnion extension channel defined in stem 3805.
  • Trunnion extension 3820 may also include a center line and may also use an extension taper for mechanical joinder of modular trunnion taper onto stem 3805.
  • the system described herein may be used to center and axially install modular trunnion taper 3810 into the channel of stem 3805.
  • Modular trunnion taper 3810 may optionally include a visible indicia marking a center line of trunnion extension 3820 to aid in non-tilting/non-canting installation of extension 3820 into the channel of stem 3805.
  • extension 3420 is aligned with center line 1715 of modular trunnion portion 3410 and grip structure 2120 or grip structure 3815 may be used for installation of both elements (extension 3820 into the channel and then head 2200 onto modular trunnion portion 3810 thereafter).
  • extension 3820 may be provided with a grip structure and head 2200 first installed onto modular trunnion portion 3810 and then the subassembly of head 2200 and modular trunnion portion 3810 thereafter installed onto stem 3805.
  • a more complex assembly system results when a center line of extension 3820 is not aligned with center line 2115 of modular trunnion portion 3810 but the system described herein may be suitably adapted for assembly, including but not limited to multiple grip structures aligned with each center line (or variable jigs for proper offset at each stage of assembly).
  • There are a number of functions may be achieved by the assembly system including establishment and maintenance of alignment of all axes during assembly, reduce inefficient use of assembly forces, and provide for measure of assembly force(s) used during assembly.
  • Reduction of inefficient energy usage may be achieved by the mechanical coupling of the two elements being joined (e.g., stem and head, stem and modular trunnion, head and modular trunnion, subassembly of head/modular taper and stem, and the like).
  • This is contrasted to a conventional approach of installing a stem into a patient bone and then using a mallet to hammer a head onto the stem - some of the kinetic energy is absorbed by the bone, body portion, operating table, and the like.
  • Another function of establishment and maintenance of axial alignment may be achieved by awareness of axes and ensuring that these axes are aligned as assembly forces are applied.
  • the various structures, systems, and processes described herein aid in the establishment and confirmation, in some cases this is done automatically, of alignment before and during application of force assembly.
  • Body 3800 of FIG. 38 differs from body 2100 of FIG. 21 not only from the description of the optional modularity of the trunnion portion, but further illustration of an optional use of a non-circular grip structure.
  • Grip structure 2120 as implemented in FIG. 36, allows clamp 3300 to rotate about pin 3605 because pin 3605 may act as axle or pivot. In some cases, such as when there is some misalignment of an application of force to the center line(s) of center line 2115. This misalignment may contribute an undesired tilting, canting, or other non-aligned assembly.
  • Body 3800 provides grip structure 3815 with an irregular perimeter that inhibits or prevents rotation.
  • the irregular perimeter need not be a regular polygon, it may be an irregular polygon. In other instances, it may be an oval, oblong, ovoid, or other non-circular perimeter.
  • anti-rotation may be provided by use of two or more grip structures that are spaced apart from any other grip structure, when the multiple grip structures are used concurrently during application of an assembly force.
  • One or both of these grip structures may include a circular perimeter.
  • the prosthesis bodies (body 2100 and body 3800) are illustrated for use in shoulder (e.g., humerus) and hip (e.g., femur) modular prosthetic assemblies.
  • shoulder e.g., humerus
  • hip e.g., femur
  • modular prostheses systems in which there are mechanical joinders of multiple prosthesis components.
  • some embodiments of the present invention may be applied to axial assembly of these other modular prosthesis systems.
  • there are modular systems for knee, ankle, wrist and other joints and skeletal systems that may benefit from use of the present invention when a body (not limited to a stem or the like) is joined to another modular component.
  • FIG. 39 - FIG. 42 illustrate a set of standard orthopedic bone preparation tools
  • FIG. 39 illustrates a perspective view of a powered bone saw 3900
  • FIG. 40 illustrates a broach attachment 4000 for a powered reciprocating bone preparation tool (a surface including a set of cutting, abrading, bone removing structures)
  • FIG. 41 illustrates a hand-operated reamer 4100
  • FIG. 42 illustrates a set of bone preparation burrs 4200.
  • these tools include an operating motion with one degree of freedom (e.g., saw 3900 has a blade that moves laterally, broach attachment 4000 reciprocates longitudinally, reamer 4100 and burrs of set of burrs 4200 each rotate about a longitudinal axis).
  • these bone preparation tools may be enhanced by adding an additional vibratory motion component, preferably but not necessarily required, that is "orthogonal" to the conventional cutting motion.
  • Saw 3900 includes a laterally reciprocating cutting blade that may be ultrasonically enhanced by an additional ultrasonic vibratory motion in one of the other five degrees of motion (e.g., vertical, longitudinal, or vibratory rotations of the blade such as pitch, yaw, and/or roll).
  • each of the conventional tools has a primary mode of freedom of motion for the bone processing and an enhancement may be made by adding an additional vibratory motion in one or more other modes of freedom.
  • Embodiments of the present invention may include an additional vibratory motion, in the primary mode and/or the additional mode(s) that may be imperceptible visually (a very small amplitude and/or very fast about or beyond 20,000 hertz).
  • an additional vibratory motion in the primary mode and/or the additional mode(s) that may be imperceptible visually (a very small amplitude and/or very fast about or beyond 20,000 hertz).
  • two types of bony surfaces are generally encountered which include flat surfaces and contained surfaces.
  • saw 3900 is used to cut the bone.
  • the contained surfaces such as the acetabulum and the proximal femur
  • broach attachment 4000 or reamer 4100 is used to prepare the bone.
  • a problem with all of these techniques is that the density of the bone is not uniform between patients and even within the same compartment or joint of a single patient.
  • the bone can be very soft or very hard and vary from region to region.
  • saw 3900 may "skive” which causes an uneven cut surface and which minimizes that chance of successful "porous ingrowth". This fact may be a principle reason that cement is still used in knee replacement.
  • For the contained bone cavities such as the acetabulum and proximal femur a "goldilocks" situation exists.
  • a surgeon may desire to know how with confidence to prepare the bone to provide just the right amount of compressive (fit). Not too loose and not too tight. Too loose leads to loosening and potential infection of the prosthesis. Too tight leads to either poor seating (which can lead to failure of fixation) or fracture (which leads to loss of press fit fixation and loosening).
  • BMD3 bidirectional vibratory tool for preparation of bone, and in particular the acetabular cavity The use of a Acetabular Broach: a new idea.
  • BMD3 bi-directional vibratory tool can be used for preparation of bone (any cavity of bone that needs to be prepared for application of a prosthesis, but especially the acetabulum, as well as the proximal femur, proximal tibia, proximal humerus, and any other long bone in the body that receives a prosthesis).
  • X is controlled by the amount of under or over reaming of the acetabulum.
  • surgeons used to under ream by 2mm Now most companies recommend under reaming by 1mm, since the surfaces of most cups are much more rough with better porosity characteristics that allow better and quicker bony ingrowth.
  • surgeons has difficulty seating the cup, he/she reams line to line, and describes this action as "touching up the rim”. This action however, many times, eliminates the compressive quality of the acetabulum by decreasing the value of x towards zero.
  • robots such as the Stryker Mako robot use a standard rotating burr, reamer or a standard saw to prepare the bone for application of a knee or hip prosthesis.
  • the term "robot” has a special meaning in the context of preparation of live bone in a living patient. Currently it is impermissible to automate any cutting of the live bone. Robot in this sense operates as a realtime constraint that provides haptic feedback to the surgeon during use when certain movements of the processing tool are outside predetermined limits.
  • An advantage of the robot is that it is helps in processing bone to within less than half a millimeter. This means that the surgeon cannot easily push the burr, reamer or saw out of the allowed haptic plane. In a sense, with the robot, the cutting tool is in safer hands.
  • These standard tools (burr, saw, reamer) provide no particular advantage for the robotic system, that is, the conventional robotic system uses conventional tools with the constraint haptic system.
  • An embodiment of the present invention may include a better job of preparation of bone.
  • a goal of some embodiments of the present invention is to obtain lower (tighter tolerances) and do it more quickly, with different tools and methods such as disclosed herein.
  • An embodiment of the present invention may include bone preparation using robotic surgery through use of haptic control and management to provide an unprecedented level of safety and accuracy coupled with modified equipment that more efficiently prepares in-patient bone while offering novel solutions for bone preparation.
  • the robotic haptic feedback may be exploited by addition and utilization of a more powerful and efficient bone cutting tool/method never before used or contemplated in orthopedics as it would have been too easy to mis- process a bone portion.
  • Ultrasonic motion may be added to traditional bone processing tools (e.g., to the tools of FIG. 39 - FIG. 42) to offer effective non-traditional bone processing tools.
  • This addition of ultrasonic energy to standard cutting, milling, reaming, burring and broaching techniques can be used to provide (methods and tools) in orthopedic surgery to remove bone more effectively with a (higher material removal rate) MMR and with significantly less force, and therefore more efficiency.
  • broach or burr can each be equipped with an ultrasonic transducer to provide an additional ultrasonic vibratory motion (e.g., longitudinal axial ultrasonic vibration).
  • ultrasonic vibratory motion e.g., longitudinal axial ultrasonic vibration.
  • This ultrasonic robotic cutting tool is therefore more powerful, fast and precise. It would cut hard and soft bone with equal efficiency.
  • the robotic operation of an ultrasonic assisted cutting tool is safe, in that the robot does not allow operation of the tool outside of the haptic safe planes.
  • a Mako robot may be equipped with a rotatory ultrasonic bone preparation tool, operating a bone processing tool (such as single metal-bonded diamond abrasive burr) that is ultrasonically vibrated, for example in the axial direction while the burr is rotated about this axis.
  • a bone processing tool such as single metal-bonded diamond abrasive burr
  • This tool can prepare both the proximal femur and acetabulum quickly with extreme precise.
  • This tool and method therefore does away with the standard manual broaching techniques used for femoral preparation and the standard reaming techniques used for acetabular preparation.
  • FIG. 39-FIG. 42 An implementation of this system of a constrained ultrasonic vibration of a bone processing tool such as a rotating burr enables a three-dimensional bone-sculpting tool or a smart tool robot.
  • the sculpting tool and smart tool robot may allow a surgeon to accurately, quickly, and safely provide non-planar contours when cutting bones as further described below while also potentially replacing all the conventional preparation tools of FIG. 39-FIG. 42.
  • the addition of the ultrasonic bone preparation tool to a robot makes the system a truly efficient and precise tool.
  • the surgeon can sculpt the surfaces of the bone, for example a femur, tibia or an acetabulum and the like, and in some implementations any tissue may be sculpted with the sculpting tool, with high degree of accuracy and speed.
  • Some implementations include an addition of an improved bone processing tool to any haptically constrained system will make the preparation of bone for joint replacement easy, fast and efficient, ultimately delivering on the promise of a better, faster and more precise operation.
  • Ultrasonic enhancement may be added to all current bone removal techniques in orthopedics, including the burr, saw, reamer, and the broach, making all of these bone preparation tools more effective.
  • burr e.g., a rotating tool with metal-bonded diamond abrasives that is ultrasonically vibrated in the axial direction
  • One important benefit of use of such a burr is that the surgeon and the smart tool robot can now very quickly and effectively machine these mating surfaces any way desired, potentially introducing waves and contours that can match the undersurface of the prosthesis (which itself has been created with waves and contours for additional stability.
  • portions of the tibia and the glenoid in the shoulder are flat bones that do not have inherent stability.
  • the sculpting/smart tool system may create prostheses that have waves and contours on their bottom surface to enhance stability when mated.
  • a bone surface may be 3D sculpted/contoured and a prosthesis produced to match the profile or a preformed contoured prosthesis may be provided with a non-flat profile and the mating bone surface may be sculpted/contoured to match the preformed non-flat prosthesis mating surface, particularly for the "flat ended" bone and the associated prostheses.
  • These contouring profiles for bone and implant mating surfaces are not limited to "flat ended” bones and may have benefit in other implants or bone mating surface.
  • FIG. 43 illustrates a side view of a first set of components 4300 for a conventional bone preparation process
  • FIG. 44 illustrates a side view of a second set of components 4400 for a three-dimensional bone sculpting process that may be enabled by some embodiments of the present invention.
  • Components 4300 include a bone B (e.g., a tibia) having a flat end 4305.
  • Flat end 4305 is typically removed by a conventional version of saw 3900, to allow an implant 4310 to be installed.
  • bone B is prepared having a flat/planar bone mating surface 4315 which matches a flat/planar implant mating surface 4320 of implant 4310.
  • the pair of mated surfaces may exhibit instability, especially with lateral shear loading.
  • Components of 4400 include bone B that has been prepared differently by removing flat end 4305 using an orthopedic sculpting system as described herein.
  • the sculpting system enables use of an implant 4405 that includes a contoured (non-flat/planar) implant mating surface 4410.
  • a bone mating surface 4415 produced by the orthopedic sculpting system is contoured to match/complement implant mating surface 4410.
  • Components 4400 may include a preformed implant 4405 and surface 4415 is sculpted to match/complement for bonding or surface 4415 is sculpted and surface 4410 is thereafter formed to match/complement surface 4415.
  • implant 4405 may include two portions - a premade head portion and a later-formed body portion that may be contoured or manufactured as needed to produce surface 4410, with the head portion and body portion joined together to produce implant 4405
  • Bone ingrowth technology has not enjoyed that same success in shoulder and knee replacement surgery as it has done in hip replacement surgery.
  • One reason that this may be true is because current methods do not allow precise and uniform preparation of bone due to variable density of bone, and especially on the flat surfaces.
  • the ultrasonic assisted bone preparation (example, the orthopedic sculpting system or smart tool robot) discussed herein has a potential to solve this problem of inconsistent bone preparation.
  • the use of the above bone preparation method/tools instead of the standard techniques may represent a disruptive technology.
  • the ability to quickly machine bone, and to do it in an extremely precise and safe manner may eliminate the need for bone cement in joint replacement surgery. This fact can cause an explosion in the use of porous ingrowth prosthesis/technology in orthopedics joint replacement surgery.
  • FIG. 45 illustrates a diagram of a smart tool robot 4500 which may include a type of three-dimensional bone processing tool.
  • Robot 4500 includes a local controller 4505 coupled to a linkage 4510 which is coupled to a high-efficiency bone processing tool 4515, with tool 4515 including a bone interface implement 4520.
  • Controller 4505 includes systems and methods for establishing and monitoring a three-dimensional spatial location for implement 4520.
  • Controller 4505 further includes governance systems for linkage 4510.
  • Collectively controller 4505 and linkage 4510 may be a type of constraint, other systems and methods for another type of constraint and providing feedback may be included in some embodiments of the present invention.
  • Linkage 4510 may include a set of sensors for a set of parameters (e.g., navigational, positional, location, force, and the like) and controller 4505 may include systems to access and read the set of parameters from linkage 4510. Alternatively, or in addition, controller 4505 may include a set of sensors producing a set of parameters. In some implementations, the set(s) of parameters may include information regarding forces, location, orientation, and motion of tool 4515 and/or implement 4520. In some embodiments, these set(s) of parameters may include information and data relative to a portion of bone 4525 that is to be processed using interface 4520 of tool 4515. Controller 4505 is secured, constrained, and/or fixed to portion of bone 4525.
  • a set of parameters e.g., navigational, positional, location, force, and the like
  • controller 4505 may include systems to access and read the set of parameters from linkage 4510.
  • controller 4505 may include a set of sensors producing a set of parameters.
  • the set(s) of parameters may include information
  • controller 4505 may be optional and linkage 4510 may be secured, constrained, and/or fixed to portion of bone 4525. Any sensors or functions associated with controller 4505 may be omitted and/or distributed among linkage 4510 and/or tool 4515 and/or interface 4520.
  • Linkage 4510 illustrated as including a mechanically limited articulating arm, is coupled to both optional controller 4505 and tool 4515 (or to portion of bone 4525).
  • controller 4505 may predefine a set of bone regions of the in-patient bone for a processing (e.g., a cutting, a removing, a reaming, a sawing, a broaching, a burring, implanting and the like).
  • Controller 4505 may monitor a relative location of interface 4520 relative to a particular portion of the in-patient bone to be processed and compare that particular portion with the predefined regions.
  • Those predefined regions may include a first subset of regions to be processed by interface 4520 and in some cases also include (or alternatively substitute for the first subset) a second subset of regions not to be processed by interface 4520.
  • Controller 4505 provides a realtime feedback to the user regarding an appropriateness or desirability of processing each the particular portion of bone at the location of interface 4520.
  • the realtime feedback may include a realtime haptic signal imparted from controller 4505 through linkage 4510 to tool 4515. That haptic signal may be of sufficient strength to significantly restrict an ability of an operator to casually move interface 4520 to a region of the in-patient bone that is not to be processed, and some cases may essentially prevent or inhibit the locating of interface 4520 to those regions of the in-patient that are not to be processed.
  • Audio feedback may in some cases be sufficient to provide feedback to an operator.
  • Tool 4515 may be an embodiment of an ultrasonically enhanced bone preparation tool which operates interface 4520.
  • Tool 4515 includes a motive system that operates interface 4520 with a bone processing motion.
  • the bone processing motion includes a primary motion having a primary freedom of motion (e.g., for a burr as illustrated, the primary motion may include a rotation about a longitudinal axis, this primary motion having a freedom of motion that includes the rotation about the longitudinal axis).
  • the bone processing motion includes a secondary motion having a secondary freedom of motion, the secondary freedom of motion different from the first freedom of motion.
  • the secondary motion includes an ultrasonic vibratory motion that enhances the bone- preparation of interface 4520 than would be the case of the primary motion alone.
  • Other tools may include tools for preparation of implant site in portion of bone 4525 and/or installation of an implant into portion of bone 4525 and/or repositioning of a mal-positioned implant installed into portion of bone 4525.
  • Different implements and tools may include varying primary and secondary motions, there generally being six freedom of motion possibilities for the primary or secondary motions: x, y, and z translations and rotations about any of the x, y, and z axes.
  • the primary motion will include a repetitive (and sometimes reciprocating) component.
  • Controller 4505 An operator grips tool 4515 and manipulates it by hand. Controller 4505
  • controller 4505 automatically monitors these manipulations to establish a relative location of interface 4520 with respect to a particular portion of an in-patient bone. Comparison of the relative location to predetermined/premapped regions of the in-patient bone that identify processable/non-processable regions results in controller 4505 is used to provide appropriate realtime feedback signals to the operator for each particular portion of bone.
  • drawings/figures can also be implemented in a more separated or integrated manner, or even removed or rendered as inoperable in certain cases, as is useful in accordance with a particular application.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Robotics (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne également un système et un procédé permettant d'améliorer l'installation d'une prothèse, en particulier d'une coque acétabulaire. Le système et le procédé peuvent comprendre la mise en oeuvre d'un mouvement relatif à vitesse constante entre une prothèse et un site d'installation. Par exemple, un système d'installation peut être fixé par rapport au site d'installation, la prothèse étant fixée dans une position initiale. La prothèse est déplacée à une vitesse constante (c'est-à-dire avec un minimum d'accélération ou d'impulsions appliquées) par rapport au site d'installation. C'est-à-dire que la prothèse ou le site d'installation peut être en mouvement. On peut ainsi réduire les forces résistives à l'installation d'une prothèse en maintenant la prothèse constamment en mouvement par rapport au site d'installation. La fixation d'un outil de traitement/implantation directement sur le site d'installation peut offrir des avantages.
PCT/US2017/046261 2016-08-11 2017-08-10 Installation de prothèse WO2018031752A1 (fr)

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US201662373515P 2016-08-11 2016-08-11
US62/373,515 2016-08-11
US15/362,675 US10660767B2 (en) 2016-01-11 2016-11-28 Assembler for modular prosthesis
US15/362,675 2016-11-28
US15/396,785 US10653533B2 (en) 2016-01-11 2017-01-02 Assembler for modular prosthesis
US15/396,785 2017-01-02
US15/398,996 2017-01-05
US15/398,996 US10251663B2 (en) 2016-01-11 2017-01-05 Bone preparation apparatus and method
US15/453,219 2017-03-08
US15/453,219 US10426540B2 (en) 2016-01-11 2017-03-08 Prosthesis installation

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