Patent Application
20150105696
The present disclosure relates to instruments, methods and systems for use in defining an implant sites for graft materials, e.g., cartilage, and harvesting graft materials from donor sites. More particularly, the present disclosure provides apparatus and systems that may be used by clinicians to define implant sites for osteochondral grafts of desired shapes, sizes and/or depths, to acquire osteochondral grafts of desired shapes, sizes and/or depths in an efficient and reliable manner, and to implant such grafts in desired locations. The disclosed instruments, methods and systems have wide clinical utility and applicability, and may be employed with beneficial results to harvest and/or implant allograft, autograft and/or synthetic materials.
Articular cartilage is a complex structure that, once damaged, has little capacity for permanent repair. One technique that has received attention for addressing cartilage-related issues involves repair with living hyaline cartilage through osteochondral autograft transplant. The procedure is known as mosaicplasty and generally involves removing injured tissue from a damaged area. One or more cylindrical sockets are drilled into the underlying bone and a cylindrical plug graft—consisting of healthy cartilage from the knee—is implanted in each socket.
As discussed in PCT applications entitled “Systems, Devices and Methods for Cartilage and Bone Grafting” and “Instruments, Methods and Systems for Harvesting and Implanting Cartilage Materials,” which published as WO 2009/154691 A9 (corrected version) and WO 2011/008968 A1, respectively, commercially available instruments for use in mosaicplasty procedures include Acufex instruments available from Smith & Nephew, Inc. (Andover, Mass.), the COR System available from Innovasive Technologies (Marlborough, Mass.), and the Arthrex Osteochondral Autograft Transfer System available from Arthrex (Naples, Fla.). The contents of the foregoing PCT applications are incorporated herein by reference.
Despite efforts to date, a need remains for instruments and systems for efficient, effective and reliable access to desired graft/cartilage sites and removal of desired graft/cartilage tissue. In addition, a need remains for instruments/systems that facilitate graft/cartilage access and/or removal in a minimally less invasive manner. Still further, a need remains for instruments/systems that facilitate effective, efficient and reliable selection of donor graft/cartilage sites and/or graft/cartilage source materials that geometrically match the removed cartilage tissue and/or void region. These and other needs are met by the instruments/systems and associated methods disclosed herein.
In accordance with embodiments of the present disclosure, an instrument for capturing a surface topography of an anatomical location is provided, generally including a plurality of elongated rod members and a locking mechanism. The locking mechanism generally releasably secures the plurality of elongated rod members relative to each other. The plurality of elongated rod members can be oriented to capture the surface topography of the anatomical location. The plurality of elongated rod members can independently translate relative to each other. The surface topography of the anatomical location generally includes a combination of a peripheral surface topography and a central surface topography of the anatomical location of a defect region. In some embodiments, the plurality of elongated rod members can include a visual indicator, e.g., a color variation, a texture variation, and the like, thereon to indicate an effectiveness of the plurality of elongated rod members to capture the surface topography of the anatomical location.
In accordance with embodiments of the present disclosure, an instrument for defining an implant region is provided, generally including a template and an adapter. The template can be configured to be driven into the anatomical location and/or secured to the anatomical location with, e.g., screws, K-wires, and the like. The adapter generally includes a plurality of elongated rod members for capturing a surface topography surrounding a defect region. In some embodiments, the plurality of elongated rod members can include a visual indicator, e.g., a color variation, a texture variation, and the like, thereon to indicate an effectiveness of the plurality of elongated rod members to capture the surface topography surrounding the defect region. The template generally defines a geometry configured and dimensioned to capture or substantially surround the defect region in the anatomical location. The geometry of the template can be one of a predetermined geometry or a variable geometry. For example, in some embodiments, the template geometry can be variable such that a user can adjust the geometry based on the configuration or dimensions of the defect region. The geometry of the template can be one of an asymmetrical geometry or a symmetrical geometry.
In some embodiments, the adapter can be detachable from the template. The exemplary instrument includes a driving mechanism, e.g., a hammer mechanism, a crank-actuated mechanism, combinations thereof, and the like, and a cutter. The hammer mechanism can be configured as a slap hammer or can facilitate the use of a drill. The crank-actuated mechanism generally includes a screw for anchoring the template to the defect region and an actuator for driving the template into the anatomical location. The driving mechanism generally drives the template into the anatomical location. As the driving mechanism drives the template into the anatomical location, the adapter generally captures the surface topography surrounding the defect region. In some embodiments, rather than driving the template into the anatomical location, screws, K-wires, and the like, can be used to secure the template to the anatomical location prior to forming a defect region cavity. The cutter generally forms one of a smooth defect region cavity or a stepped defect region cavity. The stepped defect region cavity can create a press fit between the stepped defect region cavity and a donor plug.
In accordance with embodiments of the present disclosure, an exemplary instrument for defining an implant region is provided, generally including a punch and a guide. The guide can be detachably engaged relative to the punch. In general, the guide includes a mounting mechanism, e.g., an internally threaded aperture, configured and dimensioned to facilitate interaction with an ancillary device, e.g., a hammer mechanism, a crank-actuated mechanism, a drill, and the like. The punch and the guide can cooperatively define a mechanism, e.g., a slide mechanism, a keying feature, combinations thereof, and the like, for detachably mounting the guide relative to the punch.
The guide includes an aperture configured and dimensioned to permit cutting passage therethrough. In some embodiments, the instrument includes a cutter member guide detachably engaged relative to the punch configured and dimensioned to permit cutter passage therethrough. Repositioning of the guide or the cutter member guide relative to the punch generally facilitates cutting action at a distinct location relative to the punch.
The punch can define a peripheral cutting edge, e.g., a clean cutting edge, a serrated cutting edge, and the like. In some embodiments, rather than or in combination with being driven into an anatomical location with the peripheral cutting edge, the punch can be secured or fixated to the anatomical location with, e.g., screws, K-wires, and the like, without using a hammering mechanism or mallet. In some embodiments, the punch can be partially driven into the anatomical location to position the punch relative to the anatomical location and alternative devices, e.g., screws, K-wires, and the like, can be used to secure the punch to the anatomical location. The punch generally includes at least one inner wall that defines an interior cutting region within the punch, e.g., an asymmetrical geometry, a symmetrical geometry, and the like. In some embodiments, the punch includes a peripheral template track configured and dimensioned to partially receive a mounting track therein. The punch further includes a plurality of peripheral apertures configured and dimensioned to receive therein a locking screw for securing the mounting track to the punch. The mounting track includes a plurality of apertures configured and dimensioned to receive therethrough K-wires for securing the mounting track to an anatomical location. In some embodiments, the punch includes a peripheral protrusion. Alignment of the peripheral relative to a bushing of a cutter can visually indicate a position of a drill bit within the punch.
In accordance with embodiments of the present disclosure, an exemplary graft harvesting device is provided, generally including an elongated shaft and a cutting member. The cutting member can be mounted with respect to the elongated shaft and can be operative to form a harvest cavity of a predetermined geometry. The exemplary device generally includes a plurality of elongated rod members for capturing a peripheral surface topography of an anatomical location surrounding the defect region cavity. In general, the device includes a locking mechanism for releasably locking the plurality of elongated rod members in a desired relative orientation. The plurality of elongated rod members can be actuated manually and/or electronically to translate against a surface of the anatomical location. In some embodiments, the plurality of elongated rod members include a visual indicator, e.g., a color variation, a texture variation, and the like, thereon to indicate an effectiveness of the plurality of elongated rod members to capture the peripheral surface topography of the anatomical location surrounding the defect region cavity.
The exemplary device can include a driving mechanism, e.g., a hammer mechanism, a crank-actuated mechanism, a spring-actuated mechanism, combinations thereof, and the like. The crank-actuated mechanism includes a platform for securing a donor cartilage thereon. The platform can be translatable relative to the cutting member. The crank-actuated mechanism generally includes an actuator for driving the donor cartilage into the cutting member and/or driving the cutting member into the donor cartilage. The predetermined geometry of the harvest cavity can be asymmetrical or symmetrical. The device generally includes a broach movably mounted within the cutting member. The broach can be axially translatable into a protruded position extending out of the cutting member and a retracted position within a cavity of the cutting member. The device generally includes a broach flange for regulating a position of the broach between the protruded position and the retracted position. In some embodiments, the device includes a cutter guide for trimming a donor plug extending from the cutting member.
In accordance with embodiments of the present disclosure, an exemplary method for capturing a surface topography of an anatomical location is provided, generally including establishing a referential orientation of an instrument relative to the anatomical location. The instrument generally includes a plurality of elongated rod members and a locking mechanism for releasably securing the plurality of elongated rod members relative to each other. The plurality of elongated rod members can be orientated to capture the surface topography of the anatomical location. The exemplary method includes pressing the plurality of elongated rod members against the anatomical location to capture the surface topography of the anatomical location. Pressing the plurality of elongated rod members against the anatomical location generally independently translates each of the plurality of elongated rod members relative to each other.
In accordance with embodiments of the present disclosure, an exemplary method for defining an implant region is provided, generally including establishing a referential orientation of an instrument relative to an anatomical location. The instrument generally includes a template configured to be driven into and/or secured the anatomical location and an adapter including a plurality of elongated rod members for capturing a surface topography surrounding a defect region. The exemplary method includes driving the template into and/or securing the template to the anatomical location. For example, in some embodiments, the template can be driven into the anatomical location. In some embodiments, the template can be partially driven into the anatomical location and can be further secured or fixated to the anatomical location with, e.g., screws, K-wires, and the like. In some embodiments, rather than driving the template into the anatomical location, screws, K-wires, and the like, can be used to secure the template to the anatomical location. Driving the template into and/or securing the template to the anatomical location simultaneously captures the surface topography surrounding the defect region by pressing the plurality of elongated rod members against the anatomical location. The method generally includes forming one of a smooth defect region cavity or a stepped defect region cavity with a cutter. The method includes press fitting a donor plug into the stepped defect region cavity.
In accordance with embodiments of the present disclosure, an exemplary method for defining an implant region is provided, generally including establishing a referential orientation of an instrument relative to an anatomical location. The instrument generally includes a punch and a guide detachably engaged relative to the punch. The guide includes a mounting mechanism configured and dimensioned to facilitate interaction with an ancillary device. The exemplary method includes driving the punch into and/or securing the punch to the anatomical location. For example, in some embodiments, the punch can be driven into the anatomical location. In some embodiments, the punch can be partially driven into the anatomical location and can be further secured or fixated to the anatomical location with, e.g., screws, K-wires, and the like. In some embodiments, rather than driving the punch into the anatomical location, screws, K-wires, and the like, can be used to secure the punch to the anatomical location.
In general, the method includes introducing a cutter through an aperture in the guide to define a first cut in the anatomical location. The method further includes repositioning the guide relative to the punch to reposition the aperture relative to the punch and reintroducing the cutter through the aperture in the guide to define a second cut in the anatomical location. The method includes removing the guide from the punch and introducing a clean-up cutter to an internal region defined by the punch. In some embodiments, the method includes detaching the guide from the punch and detachably engaging a cutter member guide to the punch. The cutter member guide includes an aperture configured and dimensioned to permit cutter passage therethrough and can be repositioned relative to the punch to reposition the aperture for creating a first and second cut. In some embodiments, the method includes securing a mounting track to a peripheral template track in the punch.
In accordance with embodiments of the present disclosure, an exemplary method for harvesting a donor plug is provided, generally including establishing a referential orientation of a graft harvesting device relative to a donor cartilage. The graft harvesting device generally includes an elongated shaft and a cutting member mounted with respect to the elongated shaft. The cutting member can be operative to form a harvest cavity of a predetermined geometry. The method generally includes driving the cutting member into the donor cartilage. The exemplary device generally includes a broach and a plurality of elongated rod members. The method includes axially translating the broach within the cutting member into a protruded position extending out of the cutting member. In general, the method includes driving the broach into a defect region cavity and capturing a surface topography surrounding the defect region cavity with the plurality of elongated rod members. The exemplary method includes matching the captured surface topography to a complementary topography of the donor cartilage. In some embodiments, the method includes trimming the excess portion of the donor plug extending from the cutting member.
In accordance with embodiments of the present disclosure, an exemplary instrument is provided for capturing a surface topography of a defect region. In particular, the exemplary topographical instrument generally includes a plurality of movably mounted elongated rod members and a locking mechanism for releasably securing the plurality of elongated rod members relative to each other and relative to the instrument axis. The plurality of elongated rod members may be advantageously configured and/or oriented to capture an entire surface topography of the anatomical location of a defect region, including a combination of a peripheral surface topography and a central surface topography. Further, the plurality of elongated rod members are generally independently translatable relative to each other (and relative to the instrument axis) in order to capture an accurate surface topography of the defect region.
In accordance with another embodiment of the present disclosure, an exemplary device that includes graft harvesting functionality is provided, generally including an elongated shaft and a detachable cutting member mounted with respect to the elongated shaft and operative to form a cavity or void region. In exemplary embodiments of the present disclosure, the disclosed device is adapted to form a cavity/void region of a predetermined geometry and/or depth. The exemplary device may further include a plurality of elongated rod members for capturing a topography, e.g., a peripheral surface topography, of the anatomical location in proximity to the intended or actual location of the cavity/void region, a broach member that may advantageously include structural feature(s) for at least one of cleaning and smoothing the periphery of the cavity/void region, and a hammer mechanism configured to slide relative to the axis of the shaft.
In accordance with another embodiment of the present disclosure, an exemplary instrument for removing material from a defect region is provided. The exemplary instrument generally includes a template configured and dimensioned to receive a mounting track. The exemplary instrument generally further includes a cutter configured and dimensioned to be inserted into the template. In particular, the cutter can include a travel indication feature for indicating a cutter position within the template. The template can include a peripheral template track for receiving placement of the mounting track, which further facilitates placement and anchoring of the template relative to an anatomical structure. The travel indication feature can be, e.g., a bushing, and the alignment of a template outer periphery with a travel indication feature outer periphery can indicate the cutter position within the template.
In accordance with yet another embodiment of the present disclosure, an exemplary method for defect repair is provided, generally including the steps of establishing a referential orientation of an instrument relative to an anatomical location, capturing a surface topography of the anatomical location of the defect region (e.g., a complete/entire surface topography), forming a defect region cavity that defines a cavity region geometry in the anatomical location, and using the captured surface topography of the anatomical location of the defect region to identify a donor location and/or graft source with a complementary surface topography as a harvest region or source of graft material for a plug to fill the defect region cavity. The cavity region geometry may be predefined according to the disclosed method. The graft material may be an allograft, autograft and/or synthetic material.
According to exemplary embodiments of the disclosed method, the defect region cavity is generally formed with a predefined depth and is formed at substantially a right angle relative to the axis of the instrument used to form such defect region cavity. The exemplary method generally further includes using a detachable broach member for cleaning and/or smoothing a peripheral wall associated with the defect region cavity and using a plurality of elongated rod members for capturing a surface topography of the anatomical location in proximity to the defect region cavity. Further still, the exemplary method generally includes using a cutter to obtain a graft plug from a harvest region or source of graft material (e.g., autograft, allograft and/or synthetic material), using a cutter guide to trim the graft plug to a predefined depth, using an axially movable member (e.g., a structure that also functions as the broach member) to eject the graft plug from the cutter, and introducing the graft plug into the defect region cavity. In general, the defect region cavity may be advantageously formed using a template having a predefined opening geometry. The graft plug is typically obtained using a cutter that defines a cutting geometry in which the predefined opening geometry of the template and the cutting geometry of the cutter correspond (or substantially correspond) to each other.
In accordance with embodiments of the present disclosure, an exemplary instrument for capturing a surface topography of an anatomical location is provided that generally includes a plurality of elongated rod members and a locking mechanism for releasably securing the plurality of elongated rod members relative to each other. The plurality of elongated rod members can generally be oriented to capture a surface topography of the anatomical location and can be independently translatable relative to each other. The surface topography of the anatomical location includes a combination of a peripheral surface topography and a central surface topography of the anatomical location of a defect region. In some embodiments, the plurality of elongated rod members can include a color variation thereon to indicate an effectiveness of the plurality of elongated rod members to capture the surface topography of the anatomical location.
In accordance with embodiments of the present disclosure, an exemplary instrument for removing material from a defect region is provided that generally includes a template and a detachable adapter. The template generally defines a predetermined geometry, e.g., an asymmetrical geometry, a symmetrical geometry, and the like, and can be configured to be driven into an anatomical location. The detachable adapter generally includes a plurality of elongated rod members for capturing a surface topography surrounding the defect region.
The exemplary instrument generally includes a driving mechanism and a cutter. The driving mechanism can be, e.g., a hammer mechanism, a crank-actuated mechanism, combinations thereof, and the like. The driving mechanism drives the template into the anatomical location. As the driving mechanism drives the template into the anatomical location, the detachable adapter can capture the surface topography surrounding the defect region. The crank-actuated mechanism generally includes a screw for anchoring of the template to the defect region and an actuator for driving the template into the anatomical location. The cutter can form a defect region cavity, e.g., a smooth defect region cavity, a stepped defect region cavity, and the like. The stepped defect region cavity can create a press fit between the stepped defect region cavity and a donor plug being implanted in the stepped defect region cavity.
In accordance with embodiments of the present disclosure, an exemplary assembly for defining an implant region is provided that generally includes a punch member and a guide member. The guide member can be adapted to be detachably engaged relative to the punch member. The guide member generally defines at least one aperture that can be configured and dimensioned to permit drill bit passage therethrough.
The punch member and the guide member generally cooperatively define a mechanism whereby the guide member can be detachably mounted relative to the punch member. The mechanism can be at least one of, e.g., a slide mechanism, a keying feature, and the like. Repositioning of the guide member relative to the punch member generally facilitates a cutting action at a distinct location relative to the punch member. The guide member defines a mounting mechanism to facilitate interaction with an ancillary device. The ancillary device can be, e.g., a slap hammer, a crank-actuated mechanism, and the like. The mounting mechanism can be an internally threaded aperture. The punch member can define a peripheral cutting edge selected from a group of, e.g., a clean cutting edge, a serrated cutting edge, and the like. The punch member generally includes an inner wall that defines an interior cutting region. The interior cutting region defined by the inner wall of the punch member can include a geometry selected from a group of, e.g., an oval design, a racetrack design, a pear-shaped design, and the like.
In accordance with embodiments of the present disclosure, an exemplary method for forming an implant region is provided that generally includes providing an assembly. The assembly includes a punch member and a guide member that is adapted to be detachably mounted with respect to the punch member. The guide member can define at least one cutting aperture. The method generally includes introducing a cutting member through the at least one cutting aperture to define a first cut in an anatomical location. The method further includes repositioning the guide member relative to the punch member so as to reposition the at least one cutting aperture relative to the punch member. The method includes reintroducing the cutting member through the at least one cutting aperture for defining a second cut in the anatomical location.
The exemplary method includes removing the guide member from the punch member and introducing a further cutting member to an internal region defined by the punch member. The further cutting member generally includes a bushing that controls a cutting depth thereof. Embodiments of the present disclosure are also directed to a kit including a plurality of assemblies described herein, the plurality of assemblies being of different dimensions.
In accordance with embodiments of the present disclosure, an exemplary graft harvesting device is provided that generally includes an elongated shaft and a cutting member. The cutting member can be mounted with respect to the elongated shaft and can be operative to form a harvest cavity of a predetermined geometry, e.g., an asymmetrical geometry, a symmetrical geometry, and the like. The exemplary device generally includes a plurality of elongated rod members for capturing a peripheral surface topography of the anatomical location in proximity to a defect region cavity. Further, the exemplary device generally includes a locking mechanism for releasably locking the plurality of elongated rod members in a desired relative orientation.
The plurality of elongated rod members can be actuated manually and/or electronically to translate against a surface of the anatomical location. The plurality of elongated rod members generally include a color variation thereon to indicate an effectiveness of the plurality of elongated rod members to capture the peripheral surface topography of the anatomical site. The exemplary device generally includes a driving mechanism, e.g., a hammer mechanism, a crank-actuated mechanism, combinations thereof, and the like. The crank-actuated mechanism generally includes a platform for securing a donor cartilage thereon. The platform can be translatable relative to the cutting member. The crank-actuated mechanism includes an actuator for driving the donor cartilage into the cutting member.
In accordance with embodiments of the present disclosure, an exemplary method for capturing a surface topography of an anatomical location is provided that generally includes establishing a referential orientation of an instrument relative to the anatomical location. The instrument generally includes a plurality of elongated rod members oriented to capture the surface topography of the anatomical location and including a color variation thereon to indicate an effectiveness of the plurality of elongated rod members to capture the surface topography of the anatomical location, and a locking mechanism for releasably securing the plurality of elongated rod members relative to each other. The exemplary method generally includes pressing the instrument against the anatomical location to capture the surface topography.
In accordance with embodiments of the present disclosure, an exemplary method for removing material from a defect region is provided that generally includes establishing a referential orientation of an instrument relative to the defect region. The instrument generally includes a template defining a predetermined geometry configured to be driven into an anatomical location and a detachably adapted including a plurality of elongated rod members for capturing a surface topography surrounding the defect region. The exemplary method generally includes driving the template into the defect region. In some embodiments, the method includes securing the template to the anatomical location with the defect region with, e.g., screws, K-wires, and the like. In some embodiments, the method includes partially driving the template into the defect region and securing the template to the defect region with, e.g., screws, K-wires, and the like. The exemplary method further includes capturing the surface topography surrounding the defect region simultaneously with driving the template into the defect region. Further, the exemplary method includes forming a defect region cavity, e.g., a smooth defect region cavity, a stepped defect region cavity, and the like, with a cutter.
In accordance with embodiments of the present disclosure, an exemplary method for harvesting a donor plug is provided that generally includes providing a graft harvesting device. The graft harvesting device generally includes an elongated shaft, a cutting member mounted with respect to the elongated shaft and operative to form a harvest cavity of a predetermined geometry, and a crank-actuated mechanism including a platform. The exemplary method generally includes securing a donor cartilage on the platform and driving the donor cartilage into the cutting member.
In accordance with embodiments of the present disclosure, exemplary instruments and systems for accessing and removing hyaline cartilage from desired implant sites are provided. The exemplary instruments and/or systems include a punch and a guide adapted to be detachably secured to the punch. The punch defines a cutting edge around its exposed periphery. The guide defines at least one aperture sized for receipt of a cutting member. The guide can also include means for cooperating with an ancillary device, e.g., a slap hammer, a crank-actuated mechanism, and the like, to facilitate engagement with and removal from an anatomical site. The ancillary device can typically be detachably coupled to the guide during use. The guide can be advantageously adapted to be repositioned relative to the punch such that the aperture can be relocated relative to the anatomical location. For example, the guide can be rotated by approximately 180° relative to the punch to allow introduction of the cutting member at a different controlled location relative to the anatomical location. The guide can then be removed from the punch to allow a clean-up cutting action in the region defined by the punch.
The exemplary instruments and/or systems of the present disclosure can be used with complementary instruments and/or systems to implant cartilage grafts, e.g., to fill osteochondral defects. Exemplary complementary instruments and systems are provided in a PCT application entitled “Instruments, Methods and Systems for Harvesting and Implanting Cartilage Materials,” which published as WO 2011/008968 A1.
The exemplary apparatus and/or systems may be used in connection with mapping techniques and systems of the type set forth in a PCT application entitled “Systems, Devices and Methods for Cartilage and Bone Grafting,” which published as WO 2009/154691 A9 (corrected version). Thus, in exemplary embodiments of the present disclosure, a clinician may be guided in his use of graft harvesting instrumentation by articular joint surface mapping data in locating/identifying harvest sites for “best fit” grafts, i.e., grafts that exhibit desired geometric and/or surface attributes for use in particular implantation site(s). Alternatively, the clinician may locate appropriate graft harvesting sites independent of such mapping techniques/systems. For purposes of the present disclosure, reference is made to the noted PCT application (WO 2009/154691 A9) for purposes of advantageous data mapping systems and techniques that may be employed with the disclosed instruments/systems and associated methods.
In exemplary implementations of the disclosed instruments/systems—which are adapted for use in defining a desired implant site—one or more of the following features/functionalities may be utilized in conjunction with the disclosed instruments/systems: (i) means for establishing referential orientation of instrumentation relative to an anatomical location or defect, e.g., a locking cannula assembly; (ii) means for capturing information concerning surface contour of an anatomical location, e.g., a surface contour tool featuring a plurality of circumferentially spaced, axially translatable rod/pin members and a centrally located plunger member for positioning within a defect, the surface contour tool adapted to key to a cannula assembly, or a balloon member surrounding a defect insert that is adapted to receive a curing agent; (iii) means for excising a plug from a defect plug material, such plug exhibiting a geometry that substantially conforms to the surface topography surrounding the defect site and that substantially conforms to the geometry of the defect itself, e.g., a cutting tool associated with a surface contour tool that is adapted to key to a cannula assembly; and (iv) means for implanting an excised plug in a defect.
In exemplary implementations of the disclosed instruments/systems, one or more of the following additional features/functionalities may be utilized in conjunction with the disclosed instruments/systems: (i) means for accessing a defect region-of-interest at an angle relative to an elongated shaft (e.g., approximately 90°), wherein a probe tip can be associated with a pin that moves within a control member (e.g., defect template) associated with a handle member; (ii) means for effectuating cutting functionality at an angle relative to an elongated shaft (e.g., approximately 90°), wherein the cutting blade can be adapted for movement relative to a distally-located housing between a recessed/shielded orientation and an operative orientation; and (iii) means for driving the cutting blade at an angle relative to an elongated shaft (e.g., approximately 90°), e.g., a bevel gear drive mechanism, a rotating vane mechanism, and/or a belt/pulley mechanism.
In exemplary implementations of the disclosed instruments/systems, one or more of the following further clinical features/functionalities may be utilized in conjunction with the disclosed instruments/systems: (i) means for pointing to a defect location; and (ii) means for effectuating cutting functionality at the desired defect location, wherein the foregoing functionalities are achieved utilizing in part a “four-bar” linkage mechanism.
Thus, the exemplary instruments, systems and associated methods described herein provide efficient, effective and reliable access to desired cartilage sites, removal of desired cartilage tissue and selection of donor cartilage sites or sources of graft material (allograft, autograft and/or synthetic) which geometrically match (or substantially match) an associated cavity region, and facilitate cartilage access and/or removal in a minimally invasive manner.
Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention.
To assist those of skill in the art in making and using the disclosed instruments, methods and systems, reference is made to the accompanying figures, wherein:
In accordance with embodiments of the present disclosure, an instrument is provided for capturing a surface topography of a defect region. In particular, the exemplary topographical instrument generally includes a plurality of elongated rod members and a locking mechanism for releasably securing the plurality of elongated rod members relative to each other and relative to the axis of the instrument. The plurality of elongated rod members may be configured and/or oriented to capture an entire surface topography of the anatomical location of a defect region, including a combination of a peripheral surface topography and a central surface topography. Further, the plurality of elongated rod members are generally independently translatable relative to each other in order to capture an accurate surface topography of the defect region.
In accordance with another embodiment of the present disclosure, a graft harvesting device is provided, generally including an elongated shaft and a detachable cutting member mounted with respect to the elongated shaft and operative to form a harvest cavity of a predetermined geometry. The detachable cutting member may advantageously be included in a detachable subassembly that delivers cutting functionality and potentially one or more additional functionalities. The exemplary device generally further includes a plurality of elongated rod members for capturing a surface topography of the anatomical location (e.g., a peripheral surface topography) in proximity to an existing or intended defect region cavity. The exemplary device may further include an axially movable broach member that includes structural feature(s) for cleaning and/or smoothing a peripheral wall associated with the defect region cavity, and a hammer mechanism configured to slide along the elongated shaft. The disclosed broach member may be advantageously included in the detachable subassembly that includes the cutting member, and may be axially movable relative to such cutting member.
In accordance with yet another embodiment of the present disclosure, an instrument for removing material from a defect region is provided. The exemplary instrument generally includes a template configured and dimensioned to receive a mounting track. The exemplary instrument generally further includes a cutter configured and dimensioned to be inserted into the template. In particular, the cutter can include a travel indication feature for indicating a cutter position within the template. The template can include a peripheral template track for receiving placement of the mounting track, which further facilitates placement and anchoring of the template relative to an anatomical structure. The travel indication feature can be, e.g., a bushing, and the alignment of a template outer periphery with a travel indication feature outer periphery can indicate the cutter position within the template.
Exemplary instruments and systems for accessing and removing hyaline cartilage are also provided herein. The disclosed instruments, methods and/or systems may optionally be used in connection with mapping techniques and systems of the type set forth in PCT application WO 2009/154691 A9 (corrected version) and/or instruments, methods and systems for harvesting and implanting cartilage materials of the type set forth in PCT application WO 2011/008968 A1, both of which were previously incorporated by reference. The disclosed instruments, methods and systems provide efficient, effective and reliable access to desired cartilage sites, removal of desired cartilage tissue and selection of donor cartilage sites or sources of graft material (allograft, autograft and/or synthetic) which geometrically match (or substantially match) an associated cavity region, and facilitate cartilage access and/or removal in a minimally invasive manner.
With respect to
The plurality of elongated rod members 102 can be manufactured from a material suitable for medical purposes, e.g., stainless steel, titanium, cobalt or cobalt chrome, polymeric materials, and the like, and the selected anatomical location can be a defect region 104 of, e.g., cartilage 106 of a patient. The disclosed trial member 100 can be utilized to capture surface topography at other locations, e.g., a donor site and/or an allograft or synthetic source of potential graft material. The plurality of elongated rod members 102 can be further configured to be independently translatable relative to each other and can thereby capture the specific topography of the surface directly beneath the respective elongated rod members 102, permitting an accurate capture of the entire defect region 104 surface topography. It should be noted that the size and/or number of elongated rod members 102 depicted in
Still with reference to
A locking member 108 can further be implemented for automatically securing the plurality of elongated rod members 102 relative to each other and relative to the vertical axis of the device. The elongated rod members 102 can generally be aligned in substantially parallel, e.g., in substantially aligned paths/conduits, to ensure accuracy of the captured surface topography. The locking member 108 can be configured as, e.g., a rubber O-ring, an elastic band, a sheet of silicone with a plurality of predefined openings/apertures positioned to accommodate passage of the elongated rod members 102 therethrough, a mechanical lock, and the like. As would be apparent to those of ordinary skill in the art, the locking member 108 generally provides radial resistance, e.g., a friction fit, to releasably lock the elongated rod members 102 in place in order to accurately capture the surface topography of the defect region 104.
In particular, while the trial member 100 is being lowered in proximity to the defect region 104 in order to capture the surface topography, the elongated rod members 102 can be free to independently translate along a vertical axis running the length of each elongated rod member 102 relative to each other and the locking member 108. In some embodiments, movement of the elongated rod members 102 relative to the locking member 108 can require the user to apply a vertical force against the elongated rod members 102 to overcome the locking force, e.g., a friction fit, created by the locking member 108 against the elongated rod members 102. Once the trial member 100 has been situated in an acceptable position, the locking member 108 can be actuated and/or automatically releasably locks the elongated rod members 102 in a configuration representative of the defect region 104 surface topography. Absent a mechanical lock, the locking force applied by an O-ring, elastic band or silicone sheet may be overcome by applying an adequate force on a rod-by-rod basis.
As will be discussed in greater detail below, in some exemplary embodiments, the elongated rod members 102 of the trial member 100 can include a color variation along the length of each elongated rod member 102 for indicating when a slope of the cartilage 106 surface is too steep to be measured by the length of the elongated rod members 102 being implemented. The color variation, and thereby the slope of the cartilage 106 which can be measured by the trial member 100, can depend on the protrusion length 110 of the elongated rod members 102. In particular, the protrusion length 110 can be defined as the length of the elongated rod members 102 protruding from the bottom surface 112 of the locking member 108 in the direction of the cartilage 106 surface.
For example, if the protrusion length 110 is approximately 1 inch, it should be understood that the maximum slope variation which can be measured, i.e., the maximum difference in surface topography being measured, is approximately 1 inch. That is, if the trial member 100 is pressed against a cartilage 106 surface to measure its surface topography, the elongated rod members 102 can be axially translated through the locking member 108 up to 1 inch until the bottom surface 112 of the locking member 108 abuts the cartilage 106 surface. Any variation in surface topography of greater than 1 inch would therefore not be captured, unless longer elongated rod members 102 were implemented.
In order to alert a user, e.g., a surgeon, when the elongated rod members 102 may be insufficient for measuring the surface topography of the cartilage 106, in some embodiments, the top end of the elongated rod members 102 opposing the end defining the protrusion length 110 can include a color variation. In particular, when the protrusion length 110 has been almost fully translated into the locking member 108, e.g., approximately 0.875 inches has been translated into the locking member 108, an equal length of the elongated rod members 102 can protrude from the top surface (not shown) of the locking member 108. The surface of the top end of the elongated rod members 102 past the 0.875 inch mark can include a color variation, e.g., red paint, colored markings, and the like, indicating to the user that the full protrusion length 110 has almost been translated into the locking member 108. Thus, if the protrusion length 110 is approximately 1 inch and the color variation has been reached before the desired surface topography has been fully captured, the user can, e.g., utilize a trial member 100 with longer elongated rod members 102 (such as 1.5 inches, 2 inches, 2.5 inches, 3 inches, and the like), utilize a trial member 100 for capturing a smaller surface area of the cartilage 106 which defines less topographical variations, and the like.
Once the trial member 100 has been used to capture surface topography of a defect region 104 as described herein, the trial member 100 can then be implemented for identifying an allograft and/or autograft donor location or synthetic material as a harvest region for a plug based on a complementary surface topography, e.g., matching the defect region 104 surface topography to the surface topography of a donor location. The donor location may be, e.g., a joint of the patient, an allograft joint, or a xenograft material. Alternatively, the trial member 100 may be used to contour a synthetic material.
With reference to
As described above with respect to the trial member 100 of
Turning now to
The stop element 174 of the cutter 170 can abut the top surface of the template 150 and, in particular, the top surface of the peripheral protrusion 158, to ensure a continuous and/or even depth of the defect region cavity being formed by providing support for the cutter 170 and preventing the drill bit 172 from penetrating deeper than the desired depth. The inner side surface 160 of the preformed geometric shape opening 152 can further assist the user by guiding the drill bit 172. Of note, the stop element 174 can be sized such that the outer periphery of the stop element 174 substantially aligns with the outer periphery 162 of the top surface of the template 201 or the peripheral protrusion 158 when the drill bit 172 is in abutment (or substantial abutment) with an inner side surface 160 or wall of the preformed geometric shape opening 152. In this way, a system user can determine when the drill bit 172 has reached its “outer” travel limit based on abutment with the inner side surface 160 or wall of the preformed geometric shape opening 152 without visualization thereof. Accordingly, in such exemplary embodiments, when the side surface of the disk shaped stop element 174 and the outer periphery 162 surface of the peripheral protrusion 158 of the template 150 are aligned (or substantially aligned), it should be understood that the drill bit 172 has reached the inner side surface 160 of the preformed geometric shape opening 152. It should further be understood that the outer periphery of the top surface of the template 150, i.e., the peripheral protrusion 158, can be configured and dimensioned to match the geometry of the preformed geometric shape opening 152, thereby retaining the ability indicate the “outer” travel limit based on alignment of the outer peripheries of the stop element 174 and the top surface of the peripheral protrusion 158. Thus, the user can confidently create a defect region cavity by utilizing the visual references, e.g., the travel indication feature, of the template 150 and cutter 170 to determine where a cut is being made relative to the template 150 geometry.
As discussed above, the template 150 includes a template bottom portion 154, e.g., a blade, configured for being driven into the cartilage 106. In some embodiments, the preformed geometric shape opening 152 of the template 150 can be configured and dimensioned to receive therein a guide or adapter which, in turn, can be configured and dimensioned to receive a driving mechanism. In some exemplary embodiments, the driving mechanism for driving the template bottom portion 154 into the cartilage 106 of the patient can be, e.g., an attachable hammer mechanism, an attachable crank-actuated mechanism, combinations thereof, and the like. For example, the attachable hammer mechanism and/or crank-actuated mechanism can function substantially similarly to the hammer mechanism and/or crank-actuated mechanism described below with respect to the graft harvesting device. The attachable hammer mechanism can provide the necessary force for driving the template bottom portion 154 into the cartilage 106, while the crank-actuated mechanism can reduce the toggle effect during at least a partial insertion of the template bottom portion 154 into the cartilage 106. In some exemplary embodiments, one or more stabilizing members, e.g., K-wires, and the like, can be positioned within the preformed geometric shape opening 152 and into the defect region 104 to stabilize the template 150 during insertion into the cartilage 106, while reducing the damage to healthy cartilage 106 surrounding the defect region 104.
In some exemplary embodiments, the preformed geometric shape opening 152 of the template 150 can be configured and dimensioned to receive therein a guide or adapter which further includes a plurality of elongated rod members substantially similar in function to the elongated rod members 101 described above (not shown). In particular, the guide or adapter can include a plurality of complementary openings configured and dimensioned to receive therein the plurality of elongated rod members. It should be understood that the plurality of elongated rod members can be axially translatable within the complementary openings when a force is imparted against the elongated rod members. In addition, the guide or adapter can be fabricated from a material which imparts a frictional force against the elongated rod members to maintain the elongated rod members in a “captured” position until a force greater than the friction force is imparted to an end of the elongated rod members. Thus, as the template bottom portion 154 is driven into the cartilage 106, the plurality of elongated rod members can be forced against the defect region 104 cartilage. This force can axially translate the elongated rod members through the complementary openings to capture the surface topography within or around the perimeter of the template 150, i.e., the surface topography of the defect region 104. The guide or adapter can then be removed from the template 201 to perform the subsequent steps described below.
With reference to
With reference to
In some embodiments, the locking member 160″ can include a locking mechanism (not shown) for locking the elongated rod members 162″ relative to the locking member 160″. The template assembly 150″ can be configured to receive a driving mechanism (not shown) for driving the template bottom portion 156″ into the cartilage 106. In some embodiments, rather than or in combination with being driven into the cartilage 106, the template 150″ can be secured to the cartilage 106 with, e.g., screws, K-wires, and the like. Thus, as the template assembly 150″ is driven into the cartilage 106 at a defect region 104, the plurality of elongated rod members 162″ can be forced against the cartilage 106 of the defect region. This force can axially translate the elongated rod members 162″ through the complementary apertures 164″ or openings to capture the surface topography at the perimeter of the defect region 104, i.e., the surface topography surrounding the defect region 104. The adapter 154″ can then be detached or removed from the template 152″ and used to substantially match the defect region 104 perimeter topography to a donor site. As described above, the template 152″ can remain in the cartilage 106 to allow the surgeon to create a defect region cavity.
Turning now to
As shown in
After driving the punch 202 or cutter to a desired depth in the cartilage 210, as shown in
The peripheral shape of the cutting edge 208 of the punch 202 can take various forms. In the exemplary embodiment of the figures provided herein, the cutting edge 208 defines a “racetrack” design. Exemplary alternative shapes include oval peripheries, pear-shaped peripheries, and the like. In addition, it is contemplated according to the present disclosure that the assembly 200 can be provided in different overall sizes for use in different anatomical circumstances. For example, a kit may be provided with multiple assemblies of varying sizes, thereby allowing the surgeon to select an appropriately sized assembly 200 for clinical use based on anatomical considerations. Thus, in exemplary implementations of the present disclosure, the surgeon would visualize the defect at the anatomical location, optionally select an appropriately sized (and potentially an appropriately shaped assembly 200) from among the available assemblies, and tap/drive the assembly 200 into the desired anatomical location relative to the defect, e.g., using an ancillary slap hammer that is coupled to the assembly.
Turning to
With reference to
As shown in
With reference to
The bushing 254 generally includes a lower portion 256 that engages the inner surface of side wall 220 as the cutter 250 travels within cutting region 218. The bushing 254 also includes an offset upper portion 258 which rides along and against the top portion 222 of the side wall 220 and controls the depth to which cutting bit 252 engages the anatomical location. In some embodiments, similar to the templates discussed above, the upper portion 258 of the cutter 250 and the top portion 222 of the side wall 220 can be dimensioned such that alignment of the upper portion 258 relative to the top portion 222 can visually indicate to a user when the cutting bit 252 has reaches the inner side wall 220 of the punch 202. In general, the bushing 254 maintains the cutting bit 252 within or at the edge of the cutting region 218 without contacting the punch 202. The bushing 254 also maintains the cutting bit 252 in a substantially perpendicular position relative to the punch 202. The cutting bit 252 can be offset from the center of the bushing 254 and can visually indicate the position of the cutting bit 252 in the cutting region 218. In some embodiments, the cutting bit 252 can be centered relative to the bushing 254 diameter. The clean-up cutter 250 includes a shaft 260 extending axially from the bushing 254 and can be configured and dimensioned to mechanically interlock relative to a drive mechanism (not shown) for driving the cutting bit 252 into the cartilage 210.
The clean-up cutter 250 advantageously functions to remove material left in the cutting region 218 by the first and second cutting actions of the cutting member 240, thereby generating a clean and uniform cut to a desired depth with a peripheral geometry defined by the side wall 220 of the punch 202. In particular, the clean-up cutter 250 creates substantially clean, planar and uniform side and bottom surfaces of the cutting region 218. In most instances, as illustrated in
With reference to
In accordance with further embodiments of the present disclosure, an exemplary punch/template assembly, i.e., a template assembly 200′, for use in establishing a desired implant site and creating a defect region cavity is provided in
With reference to
The punch 202′ generally includes at least one peripheral protrusion 210′ extending from the punch 202′ at an upper end opposing the cutting edge 206′. As illustrated in
The assembly 200′ can generally be adapted to cooperate with an ancillary device (see, e.g.,
Turning to
With reference to
With reference to
The clean-up cutter 250′ advantageously functions to remove material left in cutting region 208′ by the first and second cutting actions of the cutting member 230′, thereby generating a substantially clean and uniform cut to a desired depth with a peripheral geometry substantially defined by the side wall 226′ of punch 202′. For example, the clean-up cutter 250′ can create a substantially flat bottom surface of the defect region cavity configured and dimensioned to receive a complementary implant graft. In general, a single instance of travel of the clean-up cutter 250′ within the cutting region 208′ can be effective to achieve the desired result, i.e., a finished cut forming a defect region cavity 270′ as shown in
With reference to
With reference now to
The template assembly 200″ can generally be adapted to cooperate with an ancillary device, e.g., a slap hammer, a crank-actuated mechanism, and the like, that facilitates driving the punch 202″ into a desired anatomical location. For example, in some exemplary embodiments, the slap hammer can be used to drive the punch 202″ into the cartilage 214″. In some exemplary embodiments, a crank-actuated mechanism can be used to at least partially drive the punch 202″ into the cartilage 214″. As described above, the crank-actuated mechanism may be used to, e.g., reduce the toggle effect of the slap hammer, accurately drive the punch 202″ into the cartilage 214″ based on the desired angle and/or orientation, and the like. Detachable coupling of an ancillary device relative to the guide 204″ can be accomplished in various ways, e.g., threading of a distal portion of the device into a threaded aperture 216″ formed in the guide 204″, and the like. In some embodiments, rather than or in combination with being driven into the anatomical location, the punch 202″ can be secured or fixated to the anatomical location with, e.g., screws, K-wires, and the like.
As illustrated in
Turning now to
With reference to
With reference to
The clean-up cutter 250″ advantageously functions to remove material left in the cutting region by the first and second cutting actions of cutting member 230″, thereby generating a substantially clean and uniform cut to a desired depth with a peripheral geometry substantially defined by the side walls of the aperture 208″ of the punch 202″. A single instance of travel of the clean-up cutter 250″ within the cutting region can generally be effective to achieve the desired result, i.e., a finished cut as shown in
In some exemplary embodiments, the template assembly 200″ can be implemented for creating a “stepped” defect cavity region, i.e., implant region, for creating a press fit with a donor plug. With reference to
When the drill bit 262″ of the clean-up cutter 950″ (or the cutting bit 232″ of the cutting member 230″) is utilized to remove the cartilage 214″ from the defect region, the drill bit depth D2 can be regulated such that the drill bit depth D2 is greater than the punch depth D1. For example, if the punch depth D1 is approximately 6 mm, the drill bit depth D2 can be approximately 10 mm. However, it should be understood that the difference between the punch depth D1 and the drill bit depth D2 can vary depending on the size of the press fit desired. In addition, as described above, the drill bit 262″ position relative to the aperture 908″ defining the inner side surfaces of the punch 202″ can be regulated by, e.g., bushing 252″. Thus, the drill bit 262″ position can be regulated to remove cartilage material to form a defect region cavity 970″ having a width slightly smaller than the width formed by the blade of the punch 202″. In particular, as the drill bit 262″ moves within the aperture 908″ of the punch 202″, the cut formed can be substantially equivalent to the width of the inner surface 224″ of the blade. A step 272″ can thereby be formed between the cut created by the blade of the punch 202″ and the deeper cut formed by the drill bit 262″. Although illustrated in
With reference to
Turning now to
Turning now to
The mounting track 204′″ can be manufactured from a flexible yet durable material, e.g., rubber, and can be detachably secured relative to the template 202′″ by inserting a portion of the mounting track 204′″ into the groove formed in the peripheral template track 212′″ of the template 202′″ and inserting the locking screw 206′″, e.g., a set screw, thumb screw, and the like, into an appropriate pre-drilled hole 216′″. The mounting track 204′″ can thereby be detachably secured between the template 202′″ and the locking screw 206′″. Interaction between the locking screw 206′″ and a plurality of circumferentially spaced holes 216′″ permits the mounting track 204′″ to be detachably secured to the template 202′″ at a variety of orientations and can be secured to a pre-drilled hole 216′″ by hand, thereby reducing the number of tools required for surgery. The mounting track 204′″ further includes a plurality of rows/columns of K-wire holes 218′″ for insertion of K-wires 208′″ in order to secure the template 202′″ relative to the cartilage 214′″ during use. In particular, the plurality of rows/columns of K-wire holes 218′″ can be oriented at varying angles relative to a mounting surface, thereby permitting the plurality of K-wires 208′″ to be inserted at varying angles for a more secure attachment to a desired anatomical location, e.g., to prevent motion of the template 202′″ during use.
The template 202′″ generally defines a geometric shape opening 220′″ configured and dimensioned to surround a defect region 222′″ in the cartilage 214′″. Although illustrated as oval in shape, in some embodiments, the geometric shape opening 220′″ can define, e.g., a circular shape, a square shape, a rectangular shape, an irregular shape, and the like, and can be dimensioned in various sizes to effectively fully surround the defect region 222′″. In some embodiments, the template 202′″ can be configured to allow a user, e.g., a surgeon, to vary the configuration of the geometric shape opening 220′″ to conform and customize the template 202′″ to the defect region 222′″ configuration and/or dimensions. The template 202′″ also defines a template side surface 224′″. The template side surface 224′″ can define a peripheral projection which protrudes wider than the template bottom portion 210′″. Thus, in some embodiments, the peripheral template track 212′″ can act as a stop element to control the depth to which the template bottom portion 210′″ can be driven into the cartilage 214′″.
Turning now to
With reference to
Turning to
Still with reference to
The hammer mechanism 312, e.g., a slap hammer, can freely slide axially along the elongated shaft 306 between the top cap 310 and the handle 308. The axial translation of the hammer mechanism 312 can be utilized for hammering, e.g., forcibly driving and/or axially applying a force, to the graft harvesting device 300 in a downward direction by hammering against the top surface 316 of the handle 308 and/or in an upward direction by hammering against the bottom surface 320 of the top cap 310. Thus, the hammer mechanism 312 permits the surgeon to apply an axial force to advance and/or withdraw the components of the disposable portion B into and/or from the cartilage 304 without accessing an auxiliary force-delivering device and without twisting of the disposable portion B within the defect region cavity 302.
In some exemplary embodiments, rather than (or in combination with) the hammer mechanism 312, the exemplary graft harvesting device 300 can include a crank-actuated mechanism (not shown), e.g., a crank-actuated screw mechanism, and the like, for lowering the broach 322 and/or the cutting member 324 into the cartilage 304 and/or the defect region cavity 302. The crank-actuated mechanism generally reduces the potential toggle effect of the hammer mechanism 312 when driving the broach 322 and/or the cutting member 324 into the cartilage 304. Thus, in some embodiments, the crank-actuated mechanism can be implemented to initially insert and fixate the cutting member 324 and/or the broach 322 into the cartilage 304 until a steady position has been established. The hammer mechanism 312 can then be implemented to drive the cutting member 324 and/or the broach 322 to the full desired depth. In some embodiments, the crank-actuated mechanism can be implemented to drive the cutting member 324 and/or the broach 322 the full desired depth into the cartilage 304. The exemplary crank-actuated mechanism generally ensures the proper orientation, e.g., positioning, angle, and the like, of the graft harvesting device 300 relative to the cartilage 304 and/or the captured surface topography surrounding the defect region cavity 302.
The broach flange 314 can have a scalloped surface, and generally mechanically interlocks with the broach 322 to permit the broach 322 to be axially translated a maximum distance equal to the length of the broach flange path 318. The broach flange 314 can also be rotated in a direction indicated by broach flange arrows 326 to lock and/or unlock the axial movement of the broach 322. The functionality of the broach flange 314 will be discussed in greater detail below with respect to the disposable portion B.
The disposable portion B of the exemplary graft harvesting device 300 generally includes a connecting shaft 328, a lower flange 330, a locking mechanism 332, a cutting member 324, a broach 322 and a plurality of elongated rod members 334. The configuration and/or dimensions of the components of the disposable portion B can be customized to meet the needs of a user based upon, e.g., the size and/or geometry of the defect region cavity 302 of the cartilage 304 and/or the template 200 utilized. The connecting shaft 328 can be configured and dimensioned to interlock the reusable portion A components with the disposable portion B components in a mechanically functioning manner. Thus, the modular and/or disposable design of the disposable portion B permits the disposable portion B components to engage the reusable portion A, which can further be implemented for axially advancing and/or retracting the cutting member 324 and the broach 322 and for ejecting a graft plug post-harvesting. In particular, the connection between the reusable portion A and the disposable portion B permits the broach 322 to mechanically interlock and/or interact with the broach flange 314 and further permits the cutting member 324 to rigidly interlock and/or interact with the handle 308. The modularity of the disclosed graft harvesting device 300 can reduce the costs associated with the replacement of instruments required for the procedures discussed herein relative to the procedures taught by the prior art.
Still with reference to the disposable portion B of
A plurality of elongated rod members 334 can be secured to the disposable portion B around the outer perimeter of the cutting member 324 and can function substantially similarly to the elongated rod members of the trial members discussed above. The elongated rod members 334 act as male components and can be inserted into the complementary female components, e.g., apertures, located on the locking mechanism 332. Thus, as the graft harvesting device 300 is lowered against the cartilage 304 surface and the broach 322 is inserted into the defect region cavity 304, the elongated rod members 334 can be free to axially translate through the female components, e.g., apertures, of the locking mechanism 332 to capture the peripheral surface topography of the defect region cavity 302. In general, the locking mechanism 332 acts substantially similarly to the locking mechanisms described above for securing the elongated rod members 334 in a position representative of the peripheral surface topography of the defect region cavity 302 in order to locate a topographically matching harvest location.
The groove/track 336 between the top and bottom portions of the locking mechanism 332 can further receive, e.g., a rubber band and/or an O-ring element, for further frictionally locking the elongated rod members 313 in position. In some embodiments, rather than or in combination with the rubber band and/or O-ring element, the locking mechanism 332 can be fabricated from a material, e.g., a rubber, which imparts a frictional force against the plurality of elongated rod members 334 to lock the elongated rod members 334 within the locking mechanism 332 when a translational force is not being applied to the elongated rod members 334. Thus, when an axial force is applied to the distal end of the elongated rod members 334, the elongated rod members 334 can translate axially through the complementary female components of the locking mechanism 332. However, when no axial force is applied to the elongated rod members 334, the locking mechanism 332 can secure the elongated rod members 334 in the most recent position. In some embodiments, the graft harvesting device 300 can include a drive mechanism (not shown) for electronically controlling the translation of the elongated rod members 334 relative to the locking mechanism 332 and/or the cartilage 304. For example, the drive mechanism can be implemented to translate the elongated rod members 334 against the surface of the cartilage 304 around the defect region cavity 302 to capture the peripheral surface topography and the locking mechanism 332 can be implemented to lock-in the position of the elongated rod members 334 for further use of the captured surface topography. In addition, each of the plurality of elongated rod members 334 can include an elongated rod member cap 338 to prevent the elongated rod members 334 from axially passing through and out of the locking mechanism 332.
The lower flange 330 of the disposable portion B can be secured around and be axially translatable along the connecting shaft 328. In some embodiments, the lower flange 330 can act as a “stop”, e.g., an even surface which provides a limit to the axial translation of the plurality of elongated rod members 334 in an upward direction. In some embodiments, the lower flange 330 can be manually and/or electronically translated down along the connecting shaft 328 to “reset”, e.g., reposition, the plurality of elongated rod members 334. For example, by translating the lower flange 330 in a downward direction along the connecting shaft 328, a downward axial force can be applied to the elongated rod member caps 338 to reposition the plurality of elongated rod members 334 in a desired position, e.g., a position of maximum extension below the locking mechanism 332. The position of maximum extension can also be defined by the elongated rod member caps 338 positioned substantially adjacent to a top surface of the locking mechanism 332.
As described above, in some exemplary embodiments, the plurality of elongated rod members 334 can be electronically actuated to move toward and against the cartilage 304 surface. For example, the locking mechanism 332 can be electronically and/or manually translatable axially relative to the connecting shaft 328. The locking mechanism 332 can thereby be retracted, i.e., translated to be positioned substantially adjacent to the lower flange 330. Axially translating the locking mechanism 332 against the lower flange 330 generally acts to “reset”, e.g., reposition, the plurality of elongated rod members 334 such that the plurality of elongated rod members 334 can be fully extended in the direction of the cartilage 304 with the elongated rod member caps 338 positioned adjacent to the locking mechanism 332.
In some embodiments, the graft harvesting device 300 can be lowered against the cartilage 304 surface and the broach 322 can be inserted into the defect region cavity 302 without affecting the position of the plurality of elongated rod members 334. When the broach 322 has been positioned within the defect region cavity 302, the locking mechanism 332 can be electronically actuated by, e.g., a switch (not shown), to axially translate in the direction of the cartilage 304 surface. It should be understood that as the locking mechanism 332 axially translates in the direction of the cartilage 304 surface, the plurality of elongated rod members 334 also axially translate with the locking mechanism 332. Thus, when the extended distal ends of the elongated rod members 334 reach the cartilage 304 surface, the axial force applied against the distal ends of the elongated rod members 334 by the continued translation of the locking mechanism 332 can force the elongated rod members 334 to translate axially through the complementary female components of the locking mechanism 332 to capture the peripheral surface topography of the defect region cavity 302. When the peripheral surface topography has been fully captured, the locking mechanism 332 can be electronically actuated to stop the axial translation along the connecting shaft 328 and the elongated rod members 334 can maintain the captured surface topography of the area surrounding the defect region cavity 302. If the repositioning or “reset” of the plurality of elongated rod members 334 is desired, the locking mechanism 332 can be electronically and/or manually actuated to translate against the lower flange 330 to position the elongated rod members 334 in a fully extended position. Optionally, the lower flange 330 can be axially translated (electronically and/or manually) against the locking mechanism 332 to “reset” the position of the plurality of elongated rod members 334.
As described above with respect to the exemplary trial members, the elongated rod members 334 can also include a color variation (not shown) to alert a user when the elongated rod members 334 may be insufficient for measuring the topography of the area surrounding the defect region cavity 302. For example, each elongated rod member 334 can include a portion of differently colored paint, colored markings and/or varying surface texture indicating to the user that the elongated rod members 334 have been translated almost the full length through the locking mechanism. In some embodiments, rather than or in combination with the visual indicators, the graft harvesting device 300 can include an auditory indicator which emits at least one signal indicating the position of the elongated rod members 334 and/or the adequacy of the elongated rod members 334 for measuring the cartilage 304 topography. Thus, as the elongated rod members 334 are lowered and pressed against the cartilage 304 surface surrounding the defect region cavity 302, if the length of the elongated rod members 334 is insufficient to capture the topographical variation, the colored markings and/or the auditory indicator can notify the user that, e.g., longer elongated rod members 334 should be utilized. The disposable portion B can then be switched to one having longer elongated rod members 334.
Turning now to
As described above, in some exemplary embodiments, the broach 322 can be inserted into the defect region cavity 302 independently of the surface topography capture step and the locking mechanism 332 can then be electronically or manually actuated to lower the plurality of elongated rod members 334 against the cartilage 304 surface to capture the periphery surrounding the defect region cavity 302. The broach 322 can be axially driven into the defect region cavity 302 by, e.g., hammering the hammer mechanism 312 against the top surface 316 of the handle 308, actuating the crank-actuated mechanism to lower the broach 322 into the defect region cavity 302, combinations thereof, and the like.
With reference to
Turning to
With reference to
The retraction of the broach 322 enables the user to implement the peripheral surface topography of the defect region cavity 302 captured by the plurality of elongated rod members 334 to identify and/or locate, e.g., match, a harvest location having a complementary surface topography. For example, a user can position and translate the elongated rod members 334 with the captured peripheral surface topography along available harvest location surfaces to determine which harvest location surface topography substantially matches and/or aligns with the captured surface topography of the elongated rod members 334. Once a complementary surface topography of a harvest location has been located, the user can utilize the hammer mechanism 312 to axially drive the cutting member 324 downward into an allograft and/or autograft donor location for harvesting a donor graft plug. It should be understood that the donor location may be, e.g., autograft, allograft, xenograft, synthetic, and the like.
The length of the cutting member 324 can be a predetermined and customized length based on the depth of the defect region cavity 302. In addition, the retracted distance of the broach 322 into the inner cavity within the cutting member 324 ensures that the depth of the inner cavity of the cutting member 324 can be complementary to the depth of the defect region cavity 302. Thus, as the user axially drives the cutting member 324 into the allograft and/or autograft donor location, when the bottom surface of the broach 322 contacts the top surface of the allograft and/or autograft donor location, the cutting member 324 can be prevented from moving further into the allograft and/or autograft donor location and the user can understand that the desired predetermined height of the harvest graft plug has been reached. Once the desired harvest graft plug height has been reached, the cutting member 324 can be removed from the allograft and/or autograft donor location with the untrimmed harvest graft plug located inside the cavity of the cutting member 324 by utilizing the hammer mechanism 312 to axially hammer against the bottom surface 320 of the top cap 310.
Turning now to
With reference to
The connecting member 354, e.g., the arm, can connect the attachment member 352 and the cutter guide head 356 and can be configured and dimensioned to extend the cutter guide head 356 over the components of the disposable portion B. The connecting member 354 can also be configured and dimensioned to align the cutter guide channel 358 with the distal end of the cutting member 324. It should be understood that the connecting member 354 can be configured as a telescoping connecting member 354, thus permitting a user to vary the length of the connecting member 354 as needed depending on the configurations and/or dimensions of the disposable portion B components.
The cutter guide head 356 includes a cutter guide channel 358 for passing through and aligning a trimming instrument 360, e.g., a saw, with the distal end of the cutting member 324, thereby permitting an accurate trimming of the unwanted graft material of the donor graft plug 342 and ensuring a desired donor graft plug 342 depth of, e.g., about 10 mm, depending on the defect region 302 and/or joint being repaired. It should be understood that alternative desired depths can be obtained by implementing appropriately customized components of the disposable portion B, e.g., a depth of about 6 mm for a shoulder joint. Due to the desired donor graft plug 342 depth being located inside the cavity of the cutting member 324, other than aligning the trimming instrument 360 with the distal end of the cutting member 324, the user is generally not required to axially size the depth of the donor graft plug 342. Further, the implementation of the cutter guide 350 in conjunction with the desired donor graft plug 342 depth being located inside the cavity of the cutting member 324 eliminates the need for utilizing, e.g., a chisel, which could potentially dislodge the donor graft plug 342 from the graft harvesting device 300 and result in an inaccurate donor graft plug 342 geometry.
With reference to
As described above, in exemplary embodiments where the defect region cavity 302 is configured as non-symmetrical, e.g., slightly tapered, the cutting member 324 can be configured and dimensioned to substantially match the non-symmetrical defect region cavity 302 to harvest a complementary donor graft plug 342. The non-symmetrical configuration of the defect region cavity 302 and the harvested donor graft plug 342 can ensure that the proper orientation of the donor graft plug 342 relative to the defect region cavity 302 can be maintained, e.g., the depth, surface topography, and the like, are property maintained by allowing insertion of the donor graft plug 342 into the defect region cavity 302 only when the non-symmetrical configurations have been aligned.
Turning now to
The graft harvesting device 300′ can include a spring-loaded button 320′ which can function substantially similarly to the broach flange 314 of
With reference to
Turning now to
The graft harvesting device 300″ generally includes a broach flange 314″, a cutting member 316″ (e.g., a punch), a broach 318″, and a plurality of elongated rod members 320″ extending around the perimeter of the cutting member 316″, e.g., a trial device section of the graft harvesting device 300″. The handle 306″ generally includes a helical broach flange path 322″ along which the broach 318″ can travel as the broach 318″ is axially rotated by a user. The cutting member 316″ defines a blade, e.g., a serrated blade, a non-serrated blade, and the like, at a distal end, and defines a cavity within a perimeter of the cutting member 316″. The blade of the cutting member 316″ can be configured and dimensioned to be driven into a donor location for harvesting a bone and cartilage graft for implanting into the defect region cavity 302″. Although illustrated as substantially oval in shape, it should be understood that the cutting member 316″ can be configured in a variety of shapes depending on the configuration and dimensions of the defect region or the defect region cavity 302″. The cavity of the cutting member 316″ can be configured and dimensioned to receive therein the broach 318″. The broach 318″ can include a scalloped surface, e.g., ridges, blades, and the like, such that when the broach 318″ is introduced into the defect region cavity 302″, the inner surfaces of the defect region cavity 302″ can be substantially cleaned or smoothed by removing any undesired cartilage remaining after creation of the defect region cavity 302″ with the cutters discussed above. In some embodiments, the broach 318″ can be introduced into the implant region 302″ to confirm, e.g., the depth, geometry, orientation, and the like, of the implant to be harvested.
With specific reference to
The force generated by mechanical interaction between the actuator handle 308″ and the elongated shaft 324″ can be utilized to drive the cutting member 316″ and/or the broach 318″ into and out of the cartilage 304″. For example, compressing the spring 326″ and generating an axial force against the elongated shaft 324″ can drive the broach 318″ into the defect region cavity 302″. In some embodiments, expanding the spring 326″ and reducing the force generated against the elongated shaft 324″ can generate an axial pulling force which retrieves the broach 318″ and/or the cutting member 316″ from the cartilage 304″. In some embodiments, rather than implementing the actuator handle 308″, the cutting member 316″ and/or the broach 318″ can be driven into the cartilage 304″ by, e.g., manually pushing the graft harvesting device 300″ into the cartilage 304″, hammering against the actuator handle 308″, connecting an ancillary device, such as a slap hammer or a crank-actuated mechanism, to the threaded aperture 330″ on the top surface of the actuator handle 308″, and the like.
The mechanical housing 310″ can be fixedly secured to the handle 306″ by a fixation element 332″ and the trimmer guide 312″ can be fixedly secured to the mechanical housing 310″ by complementary threads 334″. The mechanical housing 310″ generally includes therein the elongated rod members 320″, a locking mechanism 336″ and a lower flange 338″. The locking mechanism 336″ generally includes a plurality of radially spaced apertures passing therethrough configured and dimensioned to receive the elongated rod members 320″. The elongated rod members 320″ can translate through the apertures independently from each other. Similar to the locking mechanism 332 discussed above, the locking mechanism 336″ can be fabricated from, e.g., a rubber, to impart a frictional force against the elongated rod members 320″ to capture the position of the elongated rod members 320″ after the surface topography surrounding the defect region cavity 302″ has been captured. In some embodiments, an O-ring or a rubber band can be implemented to impart the frictional force on the elongated rod members 320″. Each of the elongated rod members 320″ generally includes an elongated rod member cap 340″ to prevent the elongated rod members 320″ from passing fully through the apertures in the locking mechanism 336″. In some embodiments, the locking mechanism 336 can be fabricated from a rigid material and can be secured to the elongated shaft 324″ to impart the force generated by the actuated handle 308″ against the cutting member 316″ and/or the broach 318″. In some embodiments, the feature indicated in
The lower flange 338″ can be mechanically connected to the broach flange 314″ by an internal spring 344″. In some embodiments, axially rotating the broach flange 314″ along the broach flange path 322″ to a position adjacent to the fixation element 332″ can translate the lower flange 338″ down and against the elongated rod members 320″ by compressing the spring 344″ and generating a force on the lower flange 338″ to fully extend the elongated rod members 320″ from a distal end of the graft harvesting device 300″. The position of the elongated rod members 320″ can thereby be “reset” into a fully extended position. Axially rotating the broach flange 314″ along the broach flange path 322″ away from the fixation element 332″ in the direction of the actuator handle 308″ can reduce the force generated by the spring 344″ and can lift the lower flange 338″ to a position substantially adjacent to the fixation element 332″. In some embodiments, the broach flange 314″ can include broach flange indicators or arrows (not shown) thereon to indicate the direction in which the broach flange 314″ should be rotated to raise or lower the broach flange 314″ relative to the handle 306″.
In some embodiments, the broach flange 314″ can be implemented for retracting and withdrawing the broach 318″ from the cavity within the cutting member 316″. For example, rotating the broach flange 314″ down against the fixation element 332″ can withdraw the broach 318″ from the cutting member 316″, while rotating the broach flange 314″ up and away from the fixation element 332″ can retract the broach 318″ deep into the cavity of the cutting member 316″ to allow use of the cutting member 316″.
Similar to the graft harvesting device 300 discussed above, once the elongated rod members 320″ have been fully extended by the lower flange 338″, the broach 318″ can be introduced into the defect region cavity 302″ and the elongated rod members 320″ can capture the surface topography surrounding the defect region cavity 302″. In some embodiments, the broach 318″ can be introduced into the defect region cavity 302″ and the elongated rod members 320″ can be manually or electronically actuated to translate against the cartilage 304″ surface independently from the movement of the broach 318″. The captured surface topography can be further implemented to locate a substantially complementary surface topography at a harvest site for harvesting a bone and cartilage graft for implanting into the defect region cavity 302″.
Once the desired information, i.e., the peripheral surface topography, has been obtained by the elongated rod members 320″ and the broach 318″ has been used to clean the defect region cavity 302″, the broach 318″ can be withdrawn from the defect region cavity 302″. As shown in
As would be understood by those of ordinary skill in the art, the dimensions of the cutting member 316″ generally establish the desired height, i.e., depth, of the implant to be harvested. Thus, with the cutting member 316″ exposed, the graft harvesting device 300″ can be driven into a donor location until the bottom surface of the retracted broach 318″ abuts the top surface of the harvested implant. The graft harvesting device 300″ can then be retracted from the donor location with the harvested implant within the cavity of the cutting member 316″. In particular, once an implant has been harvested, the desired portion of the implant generally resides inside the cavity of the cutting member 316″ against the bottom surface of the retracted broach 318″, while the undesired portion of the implant generally extends from the cutting member 316″ for trimming.
As illustrated in
Although illustrated as a unitary structure, in some embodiments, the graft harvesting device 300″ can be configured as a disposable section and a reusable section. For example, in some embodiments, the cutting member 316″, the broach 318″, the elongated rod members 320″, the locking mechanism 336″, the fixation plate 342″, the trimmer guide 312″, the mechanical housing 310″, the lower flange 338″, the spring 344″, and the fixation element 332″ can be configured as interchangeable components to allow a user to vary the configuration and dimensions of the implant being harvested. The remaining components of the graft harvesting device 300″ can be reused to reduce the costs associated with the surgical procedures discussed herein. For example, the disposable or interchangeable components can be threaded against complementary threads located on a distal end of the handle 306″ for mechanically interlocking the disposable or interchangeable components relative to the reusable components.
For example,
With reference to
The disposable portion B of
The platform 426 can include thereon a fixation component 434 for fixating donor cartilage 436 onto the platform 426. Thus, donor cartilage 436 can be fixated to the platform 426 and the actuator 428 can be actuated to impart a force against the platform 426 to drive the donor cartilage 436, e.g., an allograft, to a desired depth in the cutting member 418. When the donor cartilage 436 has been driven into the cutting member 418 to a desired depth, the platform 426 can be translated away from the cutting member 418, leaving the harvested implant within the cutting member 418. In particular, the desired implant can remain within the cutting member 418 cavity, while the undesired portion of the harvested implant can protrude out of the distal end of the cutting member 418 for trimming. A cutting device, e.g., a saw, can then be used to trim the donor cartilage 436 along the cutter guide channel 414 and the implant can be ejected out of the cutting member 418.
In some embodiments, the graft harvesting device 400 can be detachably secured to a stable surface, e.g., an operating table, during the cartilage harvesting procedure. In some embodiments, the crank-actuated mechanism 400 can be used to initially insert and fixate the donor cartilage 436 in the cutting member 418 until a steady position and/or orientation has been established and the hammer mechanism can then be implemented to drive the cutting member 418 to the full desired depth in the donor cartilage 436. The exemplary crank-actuated mechanism 420 generally ensures the proper orientation, e.g., positioning, angle, and the like, of the graft harvesting device 400 relative to the donor cartilage 436 and/or the captured surface topography surrounding the defect region cavity and can minimize the potential toggle effect of the hammer mechanism.
With reference to
The disposable portion B′ of
The platform 428′ can include thereon a fixation component 438′ for detachably fixating a donor cartilage 440′ onto the platform 428′. Thus, a donor cartilage 440′ can be fixated to the platform 428′ and the actuator 430′ can be actuated to impart a force against the support structure 436′ to drive the donor cartilage 440′, e.g., an allograft, to a desired depth in the cutting member 420′ or drive the cutting member 420′ into the donor cartilage 440′. When the donor cartilage 440′ has been driven into the cutting member 420′ to a desired depth, or vice versa, the cutting member 420′ can be retracted from the remaining donor cartilage 440′, while housing the harvested implant within the cutting member 420′ and the undesired cartilage protruding from a distal end of the cutting member 420′ for trimming A cutting device, e.g., a saw, can then be used to trim the donor cartilage 440′ along the cutter guide channel 416′ and the implant can be ejected out of the cutting member 420′.
In some embodiments, the graft harvesting device 400′ can be detachably secured to a stable surface, e.g., an operating table, during the cartilage harvesting procedure. In some embodiments, the crank-actuated mechanism 422′ can be used to initially insert and fixate the donor cartilage 440′ in the cutting member 420′, or vice versa, until a steady position and/or orientation has been established and the hammer mechanism can then be implemented to drive the cutting member 420′ to the full desired depth in the donor cartilage 440′. The exemplary crank-actuated mechanism 422′ generally ensures the proper orientation, e.g., positioning, angle, and the like, of the graft harvesting device 400′ relative to the donor cartilage 440′ and/or the captured surface topography surrounding the defect region cavity and can minimize the potential toggle effect of the hammer mechanism.
Although exemplary instruments, methods and/or systems have been described herein as including elongated pin members for capturing surface topographies of the defect region, areas surrounding the defect region and/or donor sites, it should be understood that the features and/or functions of the disclosed instruments, methods and/or systems can be advantageously implemented independent of the elongated pin member topography capture functionality. Thus, for example, the trial members, templates and/or harvesting instruments discussed herein can be advantageously used for orthopedic applications without the elongated pin members for capturing surface topography related to the defect region and/or the donor site.
In accordance with yet another embodiment of the present disclosure, a method for defect repair is provided, generally including the steps of establishing a referential orientation of an instrument relative to an anatomical location, capturing a partial or an entire surface topography of the anatomical location of the defect region, forming a defect region cavity of a predefined geometry in the anatomical location, and using the captured surface topography of the anatomical location of the defect region to identify a donor location with a complementary surface topography as a harvest region for a plug to fill the defect region cavity. The defect region cavity can generally be formed with a predefined depth and can be formed at a substantially right angle relative to the axis of the instrument used to form the defect region cavity.
The exemplary method generally further includes using a detachable broach member for cleaning the defect region cavity and using a plurality of elongated rod members for capturing a peripheral surface topography of the anatomical location in proximity to the defect region cavity. Further still, the exemplary method generally includes obtaining a plug from the harvest region, using a cutter guide to trim the plug to a predefined depth, using a detachable broach member to eject the plug from a cutter, and introducing the plug into the defect region cavity. In general, the defect region cavity can be formed using a template having a predefined opening geometry, the plug can be obtained using the cutter having a cutting geometry, and the predefined opening geometry of the template and the cutting geometry of the cutter correspond to each other.
Turning now to
As discussed above, the exemplary instruments, methods and systems may be used in connection with mapping techniques and systems discussed in PCT applications entitled “Systems, Devices and Methods for Cartilage and Bone Grafting” and “Instruments, Methods and Systems for Harvesting and Implanting Cartilage Materials,” which published as WO 2009/154691 A9 (corrected version) and WO 2011/008968 A1, respectively, which have been previously incorporated herein by reference. Thus, in exemplary embodiments of the present disclosure, a clinician may be guided in his use of the disclosed instruments and systems by cartilage surface mapping data in locating/identifying harvest sites for “best fit” grafts, i.e., grafts that exhibit desired geometric and/or surface attributes for use in particular implantation site(s). Alternatively, the disclosed instruments, methods and systems may be employed to access anatomical sites independent of such mapping techniques/systems.
With reference to
The imaging apparatus 602 can acquire one or more images of a site in the body of a patient who has the defect, e.g., the talus surface at the foot 604, requiring a cartilage-bone graft procedure to correct. In some exemplary embodiments, the mapping system 600 also includes an optional signal processing unit 608 connected to the imaging apparatus 602. The processing unit 608 receives the signals communicated from the imaging apparatus 602 and performs signal processing and/or enhancement operations. Signal enhancement operations may include, e.g., amplification, filtering, and the like. For example, the processing unit 608 can be configured to perform noise reduction to remove noisy artifacts from acquired image data. Other types of processing can include image processing operations to transform the image data into resultant data which can be more easily manipulated for the purpose of identifying donor sites. For example, the acquired data can be processed to generate surface model corresponding to the defect region and/or the area proximate the defect region, transform spatial representations into another domain, e.g., the frequency domain, which is more conducive for various type of processing, and the like.
The processed data can subsequently be communicated to the controller processor 610. The controller processor 610 includes a storage device 612 to store the data (processed and/or raw acquired data) relating to the defect region of the patient, and to store a donor database 614 which includes information on each of a plurality of donor sites of the body. As will become apparent below, the database 614 can be constructed based on data acquired from multiple sources and/or multiple specimens. The acquired data can be used to develop and/or expand the database 614 and enhance the sensitivity and specificity of the system 600. Typically, the data stored on the database 614 pertains to healthy, non-injured specimens (or a composite representation thereof), thus enabling identification of suitable healthy sites in the body from which bone and/or cartilage can be harvested to perform bone-cartilage grafts. In some embodiments, the data stored on the database 614 pertains to defect regions, thus enabling identification of suitable defect region cavities which are compatible with the available harvest locations. In some embodiments, the data stored on the database 614 can pertain to both healthy, non-injured specimens and defect regions of various patients. The controller processor 610 can thereby be configured to receive a first data relating to a defect region of a patient and to identify, based on the received first data, at least one donor site from the donor database 614 from which a graft of bone and cartilage to repair the defect region of the patient can be harvested.
In some embodiments, the storage device 512 hosting the donor database 614, or another storage device hosting the database 507, can be located at one or more remote locations which can be accessed by multiple systems, such as the mapping system 600. Thus, such a remote device can serve as a central data repository on which data pertaining to donor sites may be stored. A user locally interacting with the system 600 can therefore access remotely, via a network 606, a database such as the database 614 to retrieve data as required. For example, and as will be described in greater details below, data pertaining to potential donor sites which is compared to data relating to a defect region can be retrieved from a remote location. Optionally, a 3D printer 616 can be locally or remotely interconnected to the controller processor 610. Such a 3D printer 616 can be used to create 3D custom templates corresponding to any identified donor site and/or to the defect region.
In some implementations, the controller processor 610 can also be configured to perform learning functions. A machine learning system is generally a system which iteratively analyzes training input data and the input data's corresponding output, and derives functions or models that cause subsequent inputs to produce outputs consistent with the machine's learned behavior. Thus, in some embodiments, the controller processor 610 can be configured to perform learning functions which include, e.g., identifying the type of donor site corresponding to newly received data, classifying the data so it is associated with other data sets corresponding to the same anatomical locations, automatically selecting several potentially suitable donor sites for further processing with respect to data received regarding the defect region, and the like. Some implementations of learning functionalities may be performed using, e.g., a neural network system implementation. A neural network includes interconnected processing elements (effectively the system's neurons), whose connections can be varied, thus enabling the neural network to adapt (or learn) in response to training data it receives. In some embodiments, a learning system may be implemented using decision trees, e.g., a graph of decisions/actions and their possible outcomes. A decision tree takes as input an object or situation described by a set of properties, and outputs a decision, i.e., an outcome. Alternatively and/or additionally, in some embodiments, the learning system may be implemented using regression techniques. Regression techniques produce functions, e.g., curves, which best fit a given set of data points. These curves can subsequently be applied to input data to determine the output based on the derived curves. Derivation of best fit curves is typically the solution to optimization problems, in which a particular error measure, e.g., least-square error, is being minimized Other types of learning system implementations may also be used.
With reference to
The processor-based device 652 can be configured to facilitate, e.g., the implementation of the data capture and/or mapping operation used to identify suitable donor sites for harvesting a graft of bone-cartilage as described herein. The storage device 656 may thus include a computer program product which, when executed on the processor-based device 652, performs operations to facilitate the implementation of the data capture, mapping and/or site identification procedures described herein. The processor-based device 652 may further include peripheral devices to enable input/output functionality, e.g., a CD-ROM drive, a flash drive, a network connection, and the like, for downloading related content to the connected system. Such peripheral devices may also be used for downloading software containing computer instructions to enable general operation of the respective system/device, as well as data from remote locations, e.g., donor site data. Alternatively and/or additionally, in some exemplary embodiments, special purpose logic circuitry, e.g., a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC) may be used in the implementation of the system 650. Other modules which may be included with the processor-based device 652 are speakers, a sound card, a pointing device, e.g., a mouse, a trackball or a touch-based graphical user interface (GUI), by which the user can provide input to the computing system 650, and the like. The processor-based device 652 may include an operating system, e.g., Windows XP® Microsoft Corporation operating system. Alternatively, other operating systems could be used. Additionally or alternatively, one or more of the procedures performed by the signal processor 608 and/or the controller processor 610 may be implemented using processing hardware, such as digital signal processors (DSP), field programmable gate arrays (FPGA), mixed-signal integrated circuits, and the like.
The various systems and devices constituting the system 600 may be connected using conventional network arrangements. For example, the various systems and devices of system 600 may constitute part of a public private packet-based network, e.g., the Internet. Other types of network communication protocols may also be used to communicate between the various systems and devices. Alternatively, the systems and devices may each be connected to network gateways which enable communication via a public network, such as the Internet. Network communication links between the systems and devices of system 600 may be implemented using wireless or wire-based links. For example, in some embodiments, the controller processor 610 may include a communication apparatus, e.g., an antenna, a satellite transmitter, a transceiver such as a network gateway portal connected to a network, and the like, to transmit and/or receive data signals. Further, dedicated physical communication links, such as communication trunks, may be used. Some of the various systems described herein may be housed on a single processor-based device, e.g., a server, configured to simultaneously execute several applications.
Referring to
For example, the data acquisition stage required for constructing the database may require that all the joint areas in a person's feet be imaged using one or more imaging devices and/or surveyed using non-imaging type devices, e.g., devices utilized to measure bone density, to obtain an accurate and comprehensive database 614. Data processed in this manner can be added to the donor database 614. As noted, in some embodiments, a learning system, e.g., implemented on the controller processor 610 or on some other dedicated processing device, may be used to process acquired data of graft sites (e.g., donor sites and/or recipient sites) which is to be added to the database 614. For example, such a learning system may be used to determine (through implemented classification functions) the identity of the site with respect to which data was received, facilitate the identification procedure to identify donor sites which would be suitable for harvesting bone-cartilage to repair the particular damaged site, and the like.
The donor sites with respect to which data is acquired and added to the database 614 include donor sites of different shapes and sizes, including donor sites suitable for harvesting non-cylindrical bone-cartilage grafts. The data for those donor sites can subsequently be used to identify suitable donor sites from which cylindrical and non-cylindrical bone-cartilage grafts can be harvested. For example, the systems described herein enable matching irregularly shaped defects of the damaged/injured recipient site(s) to available donor sites which can be used to harvest non-cylindrical bone-cartilage grafts. Conventional bone-cartilage grafting systems and methods typically extract grafts having standard shapes, e.g., cylindrical, thus limiting the repertoire of available donor sites, e.g., donor sites from which such standard shaped grafts can be harvested. Once suitable donor site are identified, various types of grafts can be harvested, including standard-shaped grafts, e.g., cylindrical grafts, as well as irregularly-shaped grafts. Harvesting irregularly shaped grafts can be performed using a set of predetermined irregularly shaped templates or, in some exemplary embodiments, by generating custom templates.
In some exemplary embodiments, the specimens used to acquire data to populate the donor site database 614 may include cadavers. Under those circumstances, more invasive data acquisition procedures may be used to acquire the data. For example, in some embodiments, one or more of a cadaver's joints may be disarticulated to expose the actual cartilage tissue. With the joint sites of the cadavers disarticulated, a high resolution image scanner may be used to scan the tissue to obtain an accurate representation of the cartilage tissue. A suitable laser scanner to scan exposed cartilage may be, e.g, a NextEngine 3D Scanner manufactured by NextEngine, Inc. Other laser scanners and/or other types of high quality image capture devices may be used.
In some exemplary embodiments, data acquired from multiple specimens, e.g., live individuals and/or cadavers, may be used to generate a composite representation of donor sites. For example, the data acquired may be averaged to obtain a general representative model of the plurality of donor sites. In some variations, several representative models of donor sites and their associated data may be generated from multiple specimens that each correspond to a particular individual type such that, when identification of a suitable donor site is undertaken, a model which is more representative of the particular traits of the patient for whom a bone-cartilage graft is required can be used. For example, different general model sets of donor sites may be constructed for male and female models.
In circumstances where the database 614 is constructed, at least partly, by collecting data about donor sites (and areas surrounding such donor sites) from specimens, a system arrangement similar to the arrangement depicted in
With reference to
Data acquired by imaging apparatus 802 for populating the donor site database may be processed to, for example, remove noisy artifacts from the image, remove unnecessary data, perform various mathematical mapping and/or transformation operations (e.g., normalization operations, re-sizing/scaling operations so all data corresponds to features at the same scale, frequency domain transformations, and the like) to transform the data into formats which are more conducive for subsequent search operation on the database. As noted, further processing on the image data (including image data on which some preliminary processing such as noise filtering and/or artifact removals have already been performed) can be performed on the data to convert it into a format which can subsequently be more easily controlled and can be more conducive for performing the donor site identification procedure described herein, e.g., using a format which enables comparisons of different donor site surfaces to one another. In some implementations, the data acquired can be used to generate surface models representative of the donor sites. The surface model may include data regarding the topology of the area, as well as other information descriptive of the area, e.g., bone thickness, bone density, and the like.
Several procedures may be used to generate the surface models. For example, in some exemplary embodiments, the captured data of the defect region can be provided as input to various computer aided design (CAD) interface applications, e.g., the SolidWorks 3D CAD application developed by Dassault Systemes SolidWorks Corp., and the like, such that the application generates a 3D rendering corresponding to the data provided. Specifically, the point cloud of data representative of an acquired image can be incorporated into SolidWorks (or any other CAD application used) to generate a resultant surface model. This data can then be stored in a format compatible with the graphical representation rendering or may be converted and stored using another type of representation of the surface model features, e.g., a representation of a composite of graphical primitives corresponding to, for example, dimensions and curvatures of lines or segments of the surface model, and the like. The generated surface model may be compared with, for example, a surface model representative of the damaged cartilage/bone of a defect region, to determine if the potential donor site would be suitable for harvesting bone-cartilage to repair the defect region of the patient. Surface comparisons may be performed visually by the operator of the system, e.g., a surgeon, who examines the surfaces compared to each other and selects one position/orientation which appears to result in the best match, or via a processing device. The procedure of matching the model surface of the defect region to model surfaces of potential donor sites can be repeated for other donor/recipient sites.
In some exemplary embodiments, the generated surface model of the donor site may be further manipulated to fit the surface model into a corresponding bone structure to provide further details on the anatomical structure of the potential donor site and provide orientation context to the user on how the surface model is overlaid relative to the bone structure. In some embodiments, the model representation of the bone structure on which the cartilage surface model is overlaid may have been acquired from other specimens, i.e., not necessarily from the same individual whose cartilage data was acquired, using an imaging device, such as an MRI imaging apparatus, a CT imaging apparatus and/or a laser scanner. Under such circumstances, when a generated surface model of the cartilage is overlaid on a previously acquired or imported model of the bone structure, small anatomical differences between the two models may be evident, e.g., topographical differences, size differences, and the like. Alternatively and/or additionally, in some embodiments, the bone structure models and the cartilage models may have been derived from the same set of specimens.
With reference again to
As further noted, the data can then be stored in a format compatible for providing graphical representations of the rendering or may be converted and stored as numerical representations of the surface model features, e.g., be represented as primitives corresponding to dimensions and curvatures of lines or segments of the surface model. Based on the captured data, a surface model of the cartilage can be generated (and in some embodiments, a model for the bone structure can also be generated) in a manner similar to that used for the surface model and bone structure models populating the donor database. This surface model may subsequently be manipulated, e.g., rotated, sized, and the like, during the donor site identification procedure to compare the defect region to donor models in the donor database.
In some exemplary embodiments, the received data relating to the defect region of the patient can be used to identify data in the donor database corresponding to the patient's defect. In other words, instead of using the data relating to the defect region to identify a donor site by comparing the data of the defect region to the donor data in the database, the data relating to the defect region can be used to first identify a corresponding non-damaged cartilage structure, i.e., the counterpart healthy cartilage from the donor database which does not have a defect, which can subsequently be used to identify a suitable donor site to harvest bone-cartilage to repair the defect region.
With continued reference to
Further, in some exemplary embodiments, the surface model data obtained from the data relating to the defect region can be used to compare, for example, the dimensions and surface curvatures of the model, to the corresponding dimensions and curvature data of the plurality of donor sites in the donor database. The two surface models can be similarly scaled and/or directionally tagged to enable an accurate comparison. The dimensions and curvatures can thus be compared to determine if the particular cartilage would be a suitable donor site to harvest bone-cartilage to repair the defect region in the body of the patient.
In performing the comparisons to identify suitable donor sites, the model surfaces can be manipulated to place them in different orientations to facilitate the comparisons. In particular, the surface model corresponding to the defect region can be rotated relative to the donor site surface models to determine an optimal matching orientation for the models being compared. For example, the surface model of the defect region can be rotated to determine how the curvatures of the surface model match different areas of the surfaces model against which it is compared. Alternatively and/or additionally, in some embodiments, the donor site surface models can be manipulated, e.g., rotated, to compare how those surfaces match the surface model of the defect region in different spatial orientations. The manipulation of the surface models may be performed using the rendering application which was used to generate the surface model or by using a separate application which can perform the manipulation using the rendered models. The results of these comparisons may be expressed using, e.g., a matching score or metric representative of how well the two surfaces matched at the particular positions and/or orientations. The level of matching may be based on the extent to which the curvatures and dimensions of the surfaces being compared fit each other, i.e., to what extent the two surfaces are congruent to each other. Such a determination may be performed by, e.g., minimizing the difference between the topologies represented by the two surface models (such as finding min(Σx,y,zVdefect(x,y,z)−Vdonor(x,y,z))), where V represents topology vector values by minimizing the least-square error of the difference between the surface model representations of the donor and defect sites. In some exemplary embodiments, the optimal matching position orientation of the model surfaces compared may be performed visually by the operator of the system, e.g., a surgeon, who examines the surfaces compared to each other and selects one position/orientation which appears to result in the best match, or by a processing device. The procedure of matching the model surface of the defect region to model surfaces of potential donor sites can be repeated for other sites.
To compare the surface model of a defect region to one or more donor site surface models through, e.g., computations based on topological features of the surfaces, and the like, the operations may be facilitated by overlaying the surface models against each other. The overlaying operations may be achieved by using built-in overlaying functions available on the particular graphical rendering application being implemented. For example, when using SolidWorks, the application's alignment function may be used to position two or more surface model appearing in a view against each other. Alternatively and/or additionally, custom-made procedures for aligning and/or overlaying multiple surface models may be implemented for use with the particular rendering application or independently of the particular rendering application.
As described herein, the donor database 614 may include donor sites from which irregularly-shaped bone-cartilage grafts, e.g., non-cylindrical grafts, can be harvested. Thus, in situations where the defect region has an irregular shape and the optimal shape of the graft would be one that is substantially similar to the irregular shape of the defect region, a surface model of the irregularly-shaped defect, generated in the manner described herein, can be used to identify suitable donor sites from which irregularly-shaped grafts can be harvested. Specifically, the surface model of such an irregularly-shaped defect region, which includes small surface segments representative of dimensions and curvatures defining the irregular shape, can be compared against one or more donor sites stored in the database 614 with respect to which similar dimension and curvature information is maintained. As described herein, such a comparison may be performed by computing, e.g., a minimum of the difference (or the least-square error) between the surface features of the surface models of the defect and surface features of the surface models of candidate donor sites. In performing such comparisons, the donor surface models and/or the surface model of defect region may be re-positioned and have their orientations manipulated to enable comparing surface features of the defect region against sub-areas in a particular donor site surface model. In other words, the matching of a defect region, e.g., an irregularly-shaped defect, includes, in some exemplary embodiments, not only identifying a suitable donor site, but also identifying appropriate sub-areas and orientations at the donor site.
In some exemplary embodiments, after identifying an appropriate position where the model surface of the defect region matches (or reasonably matches) the model surface of the donor site, a cross-sectional tool to obtain cross-sections of each surface relative to the other may be used. Such a cross-sectional tool may be implemented on the application used to render the models, e.g., Pro/Engineer, SolidWorks 3D, and the like, or by using another application, e.g., a software implemented tool. The cross-sections of each surface may be overlapped to determine congruence of, e.g., surface textures, contours, and the like.
To identify suitable donor sites, comparisons of the surface model corresponding to the defect region to surface models from the donor database may be performed according to a hierarchy of matching criteria. Thus, identified suitable donor sites may be ranked to provide a hierarchy of suitable sites from which a user, e.g., a surgeon, may select one or more of the listed sites. Examples of matching criteria include the dimensions and/or topological attributes of the donor sites, the defect directionality, the cartilage characteristics, the area around the defect, and the like. In some embodiments, evaluation of the quality of a particular suitable site may be performed in a manner analogous to the matching level score described above, in which the extent of how well the surface of the defect region matches the surface of a potential donor site is determined and a representative “topographical matching” score is generated. Another example of a matching criterion is the impact of the harvesting bone-cartilage from a particular donor site will have on the well-being of the individual. Particularly, harvesting bone-cartilage from one particular anatomical location may affect the mobility of the patient (in that the bone-cartilage may be used, under some circumstances, during movement of the patient), while harvesting bone-cartilage from another anatomical location may have little or no impact on the mobility of the patient (in that the bone-cartilage is not utilized for mobility). Accordingly, another score, i.e., an “impact” score, may be computed to represent the impact of harvesting bone-cartilage from a potential donor site. For example, various anatomical locations may be associated with predetermined impact values indicative of the impact harvesting bone-cartilage from the particular anatomical location would have on a patient's mobility or well-being. In some embodiments, a composite score which factors in the various scores derived for a particular anatomical location using the matching criteria may be determined Such a composite score may be computed, in some embodiments, as a weighted average of the various computed criteria scores for the anatomical location.
Thus, and with reference again to
While exemplary embodiments have been described herein, it is expressly noted that these embodiments should not be construed as limiting, but rather that additions and modifications to what is expressly described herein also are included within the scope of the invention. Moreover, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations are not made express herein, without departing from the spirit and scope of the invention.
This application claims the benefit of co-pending, commonly assigned U.S. Provisional Patent Application No. 61/650,841 entitled “Instruments, Methods and Systems for Defining Implant Site For Cartilage Materials,” filed on May 23, 2012, U.S. Provisional Application No. 61/664,976 entitled “Instruments, Methods and Systems for Defining Implant Site For Cartilage Materials,” filed on Jun. 27, 2012, and U.S. Provisional Application No. 61/788,693 entitled “Instruments, Methods and Systems for Harvesting and Implanting Graft Materials,” filed on Mar. 15, 2013. The entire content of the foregoing provisional patent applications is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US13/42414 | 5/23/2013 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61788693 | Mar 2013 | US | |
| 61664976 | Jun 2012 | US | |
| 61650841 | May 2012 | US |
