WO2018048863A1 - Systèmes de mise en place d'implant et procédés de fixation de tissu à une main faisant appel à ceux-ci - Google Patents

Systèmes de mise en place d'implant et procédés de fixation de tissu à une main faisant appel à ceux-ci Download PDF

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Publication number
WO2018048863A1
WO2018048863A1 PCT/US2017/050222 US2017050222W WO2018048863A1 WO 2018048863 A1 WO2018048863 A1 WO 2018048863A1 US 2017050222 W US2017050222 W US 2017050222W WO 2018048863 A1 WO2018048863 A1 WO 2018048863A1
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WO
WIPO (PCT)
Prior art keywords
implant
anchor
distal end
distal
driver
Prior art date
Application number
PCT/US2017/050222
Other languages
English (en)
Inventor
Christopher P. DOUGHERTY
Gary R. HEISLER
Robert A. Van Wyk
Original Assignee
Tenjin LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/256,838 external-priority patent/US9782250B2/en
Priority claimed from US15/429,527 external-priority patent/US9907548B2/en
Application filed by Tenjin LLC filed Critical Tenjin LLC
Publication of WO2018048863A1 publication Critical patent/WO2018048863A1/fr
Priority to US16/294,663 priority Critical patent/US11504224B2/en
Priority to US18/057,013 priority patent/US20230085430A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0445—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures

Definitions

  • the present invention relates generally to the field of endoscopic and arthroscopic surgery and suture anchor systems and devices for use therein. More particularly, the invention relates to a knotless suture anchor device utilized to secure soft tissue to bone or a boney surface to preclude the need to tie surgical knots to secure the tissue in place with the device. Specifically, the invention relates to a simplified anchor system and method by which the surgeon may introduce one or more sutures into a hole in the bone, apply tension to the sutures to advance the soft tissue to a desired location, and then advance the anchor into the bone while maintaining the suture tension and graft position.
  • a socket is drilled or punched in the bone at the attachment site and a graft is secured to the bone using an implant placed in the socket.
  • the graft may be secured to the implant by sutures, or, alternatively, an end of the graft may be placed in the socket and secured directly by an implant.
  • anchors In rotator cuff repair, implants commonly referred to as “anchors” are used. These anchors occur in two types: conventional anchors in which the suture is passed through the cuff after anchor placement, and “knotless” anchors in which the suture is passed through the cuff prior to anchor placement. In the former case, the graft is secured in place by tying knots in the suture after it has been passed through the cuff so as to secure the cuff in the desired location. Conversely, as the name implies, when using a knotless anchor, the sutures are passed through the cuff and through a feature of the anchor such that when the anchor is inserted into the socket, the suture position is secured by the anchor. Accordingly, the tying of knots is not required. This is particularly advantageous when performing endoscopic (arthroscopic) repairs since the tying of knots arthroscopically through a small diameter cannula can be difficult for some surgeons and, moreover, there is an opportunity for tangling of the sutures.
  • anchors both conventional and knotless, are supplied to the surgeon mounted on a driver - a device that the surgeon uses to place the anchor in the prepared socket in the bone.
  • the driver has a form like that of a screwdriver, and indeed functions in the same manner.
  • the proximal portion of the device forms a handle that is grasped by the surgeon.
  • an elongate distal portion has formed at its distal end features for transmitting torque to an implant.
  • Some anchors generally metallic anchors such as, for instance, the Revo® Suture Anchor by Conmed Corporation (Utica, NY) and Ti-Screw Suture Anchor by Biomet Corporation (Warsaw, IN), have a protruding (male) proximal portion with a cross-section suitable for transmitting torque (typically hexagonal or square) and a transverse eyelet formed therein.
  • the driver for such devices has a complimentary socket (female) formed in its distal end and a cannulation that extends from the interior of the socket to the proximal handle portion of the device.
  • Sutures loaded into the eyelet of the anchor extend through the driver cannulation (or "lumen") and are removably secured to the handle so as to retain the anchor in the socket of the driver.
  • Such anchors are referred to in the orthopedic arts as "pre-loaded”, meaning that sutures come loaded into an anchor that is ready for placement by the surgeon using the associated driver.
  • threaded anchors have a socket (female) formed in their proximal ends.
  • the socket has a cross-section suitable for transmitting torque that is typically polygonal, usually square or hexagonal.
  • Typical of these are the V-LoXTM family of titanium suture anchors by Parcus Medical (Sarasota, FL) and the ALLthreadTM anchors by Biomet Corporation (Warsaw, IN).
  • the drivers for such devices have a protruding (male) torque- transmitting feature complementary to the socket (female) formed in the proximal end of the anchor.
  • These drivers may be cannulated to accommodate sutures that are preloaded into the anchor in the manner previously described, with the sutures being either for the purpose of securing tissue after anchor placement, or for the purpose of removably securing the anchor to the driver, wherein the sutures are released from the driver after the anchor is placed in the bone and subsequently removed and discarded so as to allow removal of the driver from the anchor.
  • the depth of the socket in the proximal end of the implant must be sufficient to enable transmission of the requisite torque needed for anchor placement without deforming or fracturing the implant. As the maximum depth of the torque-transmitting portion is generally limited only by the configuration of the anchor, it is considered to be matter of design choice.
  • the implant may have a cannulation that extends axially through the implant as well as a torque-transmitting cross-section forming a substantial proximal portion or the entirety of the implant's length.
  • Implants of the Bio-Tenodesis ScrewTM System by Arthrex, Inc have a cannulation with a constant torque-transmitting cross-section, and are used with a driver having a torque-transmitting portion that extends beyond the distal end of the anchor, wherein the portion of the driver extending beyond the anchor and a suture loop in the driver cannulation are used together to insert the end of a graft into a prepared socket prior to placement of the implant.
  • Knotless suture anchor fixation is a common way of repairing soft tissue that has been torn from bone.
  • Illustrative examples of such "knotless" anchors include the AllthreadTM Knotless Anchors by Biomet Incorporated (Warsaw, IN), the SwiveLock® Knotless Anchor system by Arthrex, Incorporated (Naples, FL), the HEALIX KnotlessTM Anchors by Depuy/Mitek, Incorporated (Raynham, MA) and the Knotless Push-In Anchors such as the Knotless PEEK CF Anchor by Parcus Medical (Sarasota, FL). The procedure requires drilling or punching of holes into a properly prepared boney surface.
  • the suture anchor is introduced into the socket and driven into the socket using a mallet or by screwing the anchor into the socket using a driver device.
  • driver devices typically resemble a screwdriver in form, having a proximal handle portion for applying torque or percussive force, and an elongate rigid distal portion having at its distal end a torque or percussive force-transmitting configuration.
  • the distal end of the driver typically has an elongate hexagonal or square distally extending portion that, through coupling with a lumen in the anchor having a complementary cross-section, transmits torque to the anchor.
  • the lumen may extend through anchor so that the distal portion of the driver protrudes from the distal end of the anchor and rotates with the anchor during anchor placement.
  • suture is drawn into the prepared socket along with the anchor during anchor placement, it is essential that a suitable length of suture extends between the graft and the anchor so that when the anchor is suitably positioned within the socket, the graft is properly positioned. Determining the proper length of suture to allow between the anchor and the graft so as to achieve optimal graft positioning is complicated since suture(s) may twist (a process referred to in the orthopedic arts as "suture spin") during anchor placement, thereby shortening the effective length and changing the final graft position and/or undesirably increasing the suture tension.
  • suture spin a process referred to in the orthopedic arts
  • U.S. Patent No. 6,544,281 to ElAttrache et al. describes a cannulated anchor placement system having a rotating inner member (which acts as the driver) and a stationary outer member, wherein the rotating inner member serves to drive the threaded anchor.
  • the rotating “driver” extends past the distal end of the anchor and is inserted into a prepared socket in the boney surface.
  • a suture loop formed distal to the distal end of the driver "captures” or “secures” sutures attached to a graft or the graft itself to the distal end of the driver.
  • the distal end of the driver is then inserted into the socket to a proper depth for anchor placement thereby drawing the graft to the desired position prior to placement of the anchor.
  • the anchor is then threaded into the socket to the predetermined depth.
  • This system constitutes an improvement over other commercially available alternatives.
  • torque is transmitted not only to the anchor but also to the graft or sutures attached thereto by the suture loop. Accordingly, twisting of the sutures or graft frequently occurs, thereby changing the resulting suture tension and/or the graft position (a process referred to in the orthopedic arts as "graft shift").
  • U.S. Patent 8,663,279 by Burkhart et al. describes a knotless anchor system similar in construction to that of ElAttrache et al.
  • a "swivel" implant having formed therein an eyelet is releasably and pivotably mounted to the distal end of a driver distal portion that extends distally beyond the distal end of an anchor. After sutures are passed through the graft, they are threaded into the eyelet of the swivel implant at the distal end of the driver. The distal end of the driver with the swivel implant is then inserted into the socket. By pulling on the suture tails, the graft is moved into position and secured by screwing the anchor into the socket.
  • knotless anchors such as the ReelX STTTM Knotless Anchor System by
  • Stryker® Corporation Kalamazoo, MI
  • PopLok® Knotless Anchors by ConMed Corporation Utica, NY
  • the sequence of steps adds to procedure time and creates opportunities for failure of the placement procedure if a step is not performed properly.
  • a graft such as a biceps tendon is directly affixed to a bone by insertion of the graft into a socket (a technique referred to in the art as "bio-tenodesis")
  • bio-tenodesis a technique referred to in the art as "bio-tenodesis”
  • the graft be fully inserted so as to be engaged by the full length of the implant. It is also important that the position of the graft be maintained during anchor insertion. Further, it is essential that the alignment of the implant (referred to in this case as an “interference screw”) be coaxial, or if slightly shifted, parallel to the axis of the socket.
  • a primary objective of the present invention is to provide improved means and methods of attaching soft tissues (i.e., "grafts") to bone in situ.
  • grafts soft tissues
  • the embodiments of the instant invention are described hereinbelow as a system and method for the placement of a simple one-piece cannulated anchor or for producing a matrix of implants for the anchoring of a graft to bone.
  • Any graft fixation system which uses an implant placement device (driver) with an optionally cannulated non-rotating tensioning element or assembly (i.e., the relatively fixed "inner assembly”) positioned within a cannulation or "lumen” of a cannulated driver (i.e., the relatively movable “outer assembly”) to tension sutures in a prepared socket for the placement of a simple one-piece cannulated anchor are contemplated by the present invention.
  • an implant placement device with an optionally cannulated non-rotating tensioning element or assembly (i.e., the relatively fixed "inner assembly") positioned within a cannulation or "lumen” of a cannulated driver (i.e., the relatively movable “outer assembly”) to tension sutures in a prepared socket for the placement of a simple one-piece cannulated anchor
  • the present invention provides prosthetic implants and devices for their placement in a target boney surface for the knotless securing of a soft tissue graft thereto.
  • the instant invention contemplates a novel placement system including a non- rotating cannulated tensioning assembly ("inner assembly") positioned within a rotationally and axially movable cannulated driver (“outer assembly").
  • a tubular distal element of the tensioning assembly extends distally beyond the distal end of the cannulated driver.
  • a cannulated threaded implant (or “anchor”) is removably mounted to the torque-transmitting distal portion of the driver.
  • the distal end of the cannulated driver preferably includes torque-transmitting features that, together with complementary features formed in the proximal portion of the implant or anchor, allow the transmission of torque thereto.
  • the distal end of the driver is preferably configured to transmit axial force to the anchor, the proximal end of which has a suitably complementary configuration to enable secure attachment.
  • sutures placed in the graft are drawn into the distal end of the tensioning assembly.
  • the elongate distal element of tensioning assembly is inserted into a properly prepared socket in the target boney surface so that the distal end of the tensioning element, with its sutures is positioned at the bottom of the socket.
  • Tension is then applied to the sutures by pulling on their proximal ends, which extend beyond the proximal portion of the tensioning assembly to move the graft into the desired position.
  • the desired tension may be maintained by cleating proximal portions of the suture(s) into slots optionally formed in the handle of the tensioning assembly.
  • the anchor (or interference screw) may then be screwed, threaded or otherwise driven into the socket, thereby trapping the sutures or graft between the anchor exterior surface and the socket wall.
  • twisting of the suture(s) or graft(s) is prevented by the non-rotating distal tubular portion of the tensioning assembly that remains distal to the anchor distal end during anchor placement.
  • tension on the sutures and the position of the graft are maintained during placement of the anchor throughout the procedure.
  • the driver device is withdrawn, removed from the site, at which point the sutures may be trimmed to complete the procedure.
  • suture tensioning and establishment of the graft position are not accomplished using the driver's distal end or using an implant positioned in the driver's distal end. Rather, suture tension and graft position are established and maintained by the distal portion of a non-rotating tensioning element that extends beyond the driver and anchor distal ends. Because of this, the transmission of torque to the sutures and/or graft by the driver present in the Burkhart and ElAttrache systems is eliminated, along with its associated suture or graft spin.
  • the system and method of the instant invention provide a simplification over other currently available anchoring methods and hardware in that fewer steps are required and moreover the anchor has a simple, single-piece construction.
  • the anchor system is scalable and, due to its simple construction, may be used with anchors smaller than those permitted using other currently available systems.
  • the composition and construction of the anchor may be readily modified simply by changing the material from which it is constructed, by increasing or reducing the diameter or length of the anchor, by increasing or decreasing the wall thickness of the anchor, by modifying the profile of the exterior, or by any combination of these means. All such modifications are contemplated as within the scope of the present invention.
  • the present invention provides a method for affixing a soft tissue graft to a target boney surface, the method including the steps of:
  • a placement device having a cannulated non-rotating tensioning assembly ("inner assembly”) and a cannulated driver device (“outer assembly”), wherein the tensioning assembly is positioned within the cannulation or "lumen" of the driver device,
  • a suitably configured hole i.e., "socket" in a prepared boney surface at a desired target location using a drill, tap, punch or equivalent hole-producing device,
  • tubular distal element of the tensioning assembly is replaced by a rod having formed at its distal end a sharpened fork portion.
  • Two (or more) parallel, axially extending tines form the fork, the tines being spaced apart so that sutures may slide freely through the channel(s) formed between the tines.
  • An anchor placement device commensurate with such an embodiment is used in the following manner: First, a cannulated threaded implant is removably mounted to the torque- transmitting distal portion of the outer assembly of the driver. Sutures placed in the graft are then positioned in the channel(s) of the distal fork portion of the tensioning device.
  • the elongate distal element of the tensioning assembly with the sutures positioned within its distal channel is then inserted into a prepared socket so that the distal end of the tensioning device with its sutures is positioned at the bottom of the socket.
  • Tension is then applied to the sutures by pulling on their proximal ends to draw the graft into the desired position.
  • the desired tension and graft position may be maintained by cleating the suture proximal portions in slots optionally formed in the handle of the tensioning device.
  • the anchor is then screwed, threaded or otherwise axially driven into the socket by the driver, thereby trapping the sutures or graft between the anchor exterior surface and the socket wall.
  • Twisting of the sutures or graft is prevented by the non-rotating distal fork element of the tensioning assembly that remains distal to the anchor distal end during anchor placement.
  • the tension on the sutures and the position of the graft are maintained during placement of the anchor.
  • the driver device is removed from the site and the sutures trimmed to complete the procedure.
  • the tensioning assembly may be cannulated and coupled with an elongate element formed from a suitable shape memory metal and/or superelastic polymeric material that, in a first configuration, is provided with a suture retention loop at its distal end.
  • the distal end of the elongate element extends out of and distally away from the distal end of the cannulated tensioning device so as to be accessible to free suture ends.
  • one or more sutures are loaded into the distal retention loop. The sutures are then tensioned and secured as previously described, through cooperation of the cannulated tensioning assembly, cannulated anchoring implant and torque-transmitting driver device.
  • the elongate element may be readily transformed into a second relatively linear configuration and axially withdrawn from the tensioning lumen.
  • the elongate element may preferably take the form of a nitinol wire.
  • An anchor placement system of the present embodiment may also include a mechanism for releasably preventing relative axial and rotational movement between the driver outer assembly and the tensioning assembly, such means optionally positioned within the cannulation (or "lumen") of the driver outer assembly.
  • a mechanism for releasably preventing relative axial and rotational movement between the driver outer assembly and the tensioning assembly such means optionally positioned within the cannulation (or "lumen") of the driver outer assembly.
  • a first condition used during tensioning of the suture
  • the driver outer assembly may be advanced axially on the tensioning assembly to bring the anchor to the socket, and rotated to screw the anchor into the socket, with the tensioning assembly remaining stationery so as to maintain suture tension and prevent twisting of the sutures.
  • a suitable tensioning assembly is irremovably (i.e., permanently) affixed to and/or positioned within an associated driver device outer assembly, the driver outer assembly is axially movable between a first proximal position and a second distal position relative to the tensioning assembly.
  • the distal element of the tensioning assembly extends distally beyond the implant so as to allow tensioning of sutures and positioning of a graft as described previously herein as well as in related co-pending applications incorporated herein by reference.
  • Advancing the driver distally toward its second, distal position brings the implant to the prepared socket in preparation for placement.
  • the implant is threaded or axially driven into the socket.
  • Distal motion by the driver outer assembly relative to the tensioning device may be resisted by a spring within the driver device handle or by other motion resistive means such as, for instance, a friction producing element.
  • the resistance to distal motion is sufficient to ensure that the distal end of the tensioning device remains in contact with the bottom of the socket to maintain graft position and to prevent rotation of the tensioning device during anchor placement.
  • the suture attached to the graft is positioned within the distal fork and tensioned such that a first end of the graft is adjacent to the fork, the tension optionally being maintained by cleating of the sutures on the tensioning assembly hub.
  • the distal element of the tensioning assembly with the graft is inserted into the prepared socket.
  • the anchor is then threaded or driven into the socket as previously described, thereby trapping a graft portion adjacent to the first end of the graft between the anchor exterior surface and a first portion of the socket wall, and the attached sutures between the anchor exterior surface and a second, laterally opposed portion of the socket wall.
  • the graft may be pierced by the sharpened distally extending members of the distal fork.
  • the distal portion of the tensioning element with the graft is inserted into the prepared socket.
  • the anchor is then threaded or driven into the socket, thereby trapping the graft proximal portion between the anchor exterior surface and a portion of the socket wall.
  • the graft is pierced by the sharpened distally extending members of the distal fork a predetermined distance from the graft distal end such that when the distal portion of the tensioning element with the graft is inserted into the prepared socket, the proximal end of the graft protrudes above the opening of the socket.
  • the anchor is then threaded or driven into the socket, thereby trapping the graft proximal portion between the anchor exterior surface and first and second laterally opposed portions of the socket wall.
  • the distal fork is replaced by a single, sharpened, protruding portion configured for penetration of a graft.
  • a "washer” formed of a suitable material is removably mounted on the sharpened protruding portion to limit the depth of penetration of the sharpened portion into the graft. When the anchor is placed, this depth- limiting washer remains in the socket positioned distal to the anchor, between the anchor and the graft.
  • the distal fork is configured not for tissue penetration, but for the retention of sutures placed therein during tensioning, the distally extending portions forming a suture retaining split loop with a distal gap to allow the placement of sutures therein and their exit after anchor placement.
  • the distally extending portions are formed of a resilient polymeric material such that the portions may be inwardly deflected during withdrawal of the placement system after anchor placement.
  • any graft fixation system that uses a non-rotating inner member (tensioning assembly) and a movable outer member (driver) to tension sutures in a prepared socket for the placement of a simple one-piece cannulated anchor falls within the scope of this invention.
  • tensioning assembly tensioning assembly
  • driver movable outer member
  • Figure 1 is a perspective view of a prior art device.
  • Figure 2 is a perspective view of the distal portion of a prior art device.
  • Figure 3 is a perspective view of the exploded assembly of a prior art device.
  • Figure 4 is a perspective view of the exploded assembly of a second prior art device.
  • Figure 5 is a perspective view of an outer assembly for an implant placement device of the present invention.
  • Figure 6 is a plan view of the objects of Figure 5.
  • Figure 7 is a side elevational view of the objects of Figure 5.
  • Figure 8 is a sectional view of the objects of Figure 6 at location A - A.
  • Figure 9 is a perspective view of an inner assembly for an implant placement device of the present invention.
  • Figure 10 is a plan view of the objects of Figure 9.
  • Figure 11 is an expanded sectional view of the objects of Figure 10 at location A - A.
  • Figure 12 is an expanded view of the objects of Figure 11 at location A.
  • Figure 13 is a perspective view of a slide control element for an implant placement device of the present invention.
  • Figure 14 is a side elevational view of the objects of Figure 13.
  • Figure 15 is a perspective view of the exploded assembly of an implant placement device of the present invention.
  • Figure 16 is a perspective view of an implant placement device of the present invention.
  • Figure 17 is a plan view of the objects of Figure 16.
  • Figure 18 is a side elevational view of the objects of Figure 16.
  • Figure 19 is an expanded sectional view of the objects of Figure 17 at location A - A.
  • Figure 20 is an expanded sectional view of the objects of Figure 17 at location B - B.
  • Figure 21 is an expanded view of the objects of Figure 19 at Location A.
  • Figure 22 is an expanded view of the objects of Figure 21 at location C.
  • Figure 23 is a perspective view of the device of Figure 16 with the outer driver assembly in its distal position.
  • Figure 24 is a plan view of the objects of Figure 23.
  • Figure 25 is a side elevational view of the objects of Figure 23.
  • Figure 26 is an expanded sectional view of the objects of Figure 24 at location A - A.
  • Figure 27 is an expanded sectional view of the objects of Figure 24 at location B - B.
  • Figure 28 is a perspective view of the exploded assembly of a alternate embodiment implant placement device of the present invention.
  • Figure 29 is a perspective view of the assembled elements of the alternate embodiment implant placement device of Figure 28.
  • Figure 30 is an expanded view of the objects of Figure 29 at location A.
  • Figure 31 is a plan view of the objects of Figure 29.
  • Figure 32 is a side elevational view of the objects of Figure 29.
  • Figure 33 is an expanded sectional view of the objects of Figure 31 at location B - B.
  • Figure 34 is an expanded sectional view of the objects of Figure 31 at location A - A.
  • Figure 35 is a proximal axial view of the objects of Figure 31.
  • Figure 36 is a perspective view of the alternate embodiment implant placement device of Figure 29 with the outer driver assembly in its distal position.
  • Figure 37 is a plan view of the objects of Figure 36.
  • Figure 38 is a side elevational view of the objects of Figure 36.
  • Figure 39 is an expanded sectional view of the objects of Figure 37 at location B - B.
  • Figure 40 is an expanded sectional view of the objects of Figure 37 at location A - A.
  • Figure 41 is a side elevational view of an alternate embodiment implant placement device of the present invention.
  • Figure 42A is an expanded view of the objects of Figure 41 at location A.
  • Figure 42B is an expanded view of the distal portion of the objects of Figure 41.
  • Figure 43A is a plan view of the distal end of a tensioning element of an alternate embodiment implant placement device of the present invention.
  • Figure 43B is a distal perspective view of the objects of Figure 44.
  • Figure 43 C is a proximal perspective view of the objects of Figure 44.
  • Figure 44 is a perspective view of the exploded assembly of an alternate embodiment implant placement device of the present invention.
  • Figure 45 is a perspective view of the assembled elements of Figure 44.
  • Figure 46 is a plan view of the objects of Figure 45.
  • Figure 47 is an expanded view of the objects of figure 45 at location B.
  • Figure 48 is an expanded view of the objects of Figure 46 at location A.
  • Figure 49 is an expanded view of the objects of Figure 47 at location C.
  • Figure 50 is a perspective view of a depth limiting element of the present invention.
  • Figure 51 is an axial view of the objects of Figure 50.
  • Figure 52 is a plan view depicting the depth limiting element of Figure 50 positioned on a distal tensioning element like that depicted in Figure 30.
  • Figure 53 is an expanded view of the objects of Figure 52 at location D.
  • Figure 54 is a perspective view of the objects of Figure 52.
  • Figure 55 is an expanded view of the objects of Figure 54 at location C.
  • Figure 56 is a perspective view of an alternate embodiment depth limiting element positioned in preparation for removable mounting to an alternate embodiment distal tensioning element of the present invention.
  • Figure 57 is a perspective view of the elements of Figure 56 assembled in preparation for use.
  • Figure 58 depicts a first step in attaching a graft by bio tenodesis using a placement device and depth limiting element of the present invention.
  • Figure 59 depicts a second step in attaching a graft by bio tenodesis using a placement device and depth limiting element of the present invention.
  • Figure 60 depicts a third step in attaching a graft by bio tenodesis using a placement device and depth limiting element of the present invention.
  • Figure 61 depicts a fourth step in attaching a graft by bio tenodesis using a placement device and depth limiting element of the present invention.
  • Figure 62 depicts a fifth step in attaching a graft by bio tenodesis using a placement device and depth limiting element of the present invention.
  • Figure 63 depicts the site at the completion of attachment of a soft tissue graft using a placement device and depth limiting element of the present invention.
  • proximal refers to that end or portion which is situated closest to the user of the device, farthest away from the target surgical site.
  • proximal end of the implant system of the present invention includes the driver and handle portions.
  • distal refers to that end or portion situated farthest away from the user of the device, closest to the target surgical site.
  • the distal end of the implant systems of the present invention includes components adapted to fit within the pre-formed implant-receiving socket.
  • cancer and “cannulated” are used to generically refer to the family of rigid or flexible, typically elongate lumened surgical instruments that facilitate access across tissue to an internally located surgery site.
  • tube and “tubular” are interchangeably used herein to refer to a generally round, long, hollow component having at least one central opening often referred to as a "lumen”.
  • lateral pertains to the side and, as used herein, refers to motion, movement, or materials that are situated at, proceeding from, or directed to a side of a device.
  • medial pertains to the middle, and as used herein, refers to motion, movement or materials that are situated in the middle, in particular situated near the median plane or the midline of the device or subset component thereof.
  • the present invention is directed to various means and mechanisms for securing the displaced tissue to boney tissue.
  • tissue refers to biological tissues, generally defined as a collection of interconnected cells that perform a similar function within an organism.
  • tissue includes cells, including the human body and lower multicellular organisms such as insects, including epithelium, connective tissue, muscle tissue, and nervous tissue. These tissues make up all the organs, structures and other body contents. While the present invention is not restricted to any particular soft tissue, aspects of the present invention find particular utility in the repair of connective tissues such as ligaments or tendons, particularly those of the shoulder, elbow, knee or ankle joint.
  • graft refers to any biological or artificial tissue being attached to the boney tissue of interest, including:
  • Autografts i.e., grafts taken from one part of the body of an individual and transplanted onto another site in the same individual, e.g., ligament graft;
  • Isografts i.e., grafts taken from one individual and placed on another individual of the same genetic constitution, e.g., grafts between identical twins;
  • Allografts i.e., grafts taken from one individual placed on genetically non-identical member of the same species;
  • Xenografts i.e., grafts taken from one individual placed on an individual belonging to another species, e.g., animal to man.
  • Autografts and isografts are usually not considered as foreign and, therefore, do not elicit rejection. Allografts and xenografts are recognized as foreign by the recipient thus carry a high risk of rejection. For this reason, autographs and isografts are most preferred in the context of the present invention.
  • Surgical interventions such as contemplated herein generally require the boney tissue to be prepared for receiving the graft.
  • preparation includes the formation of a "socket", i.e., a hole punched or drilled into the bone into which a prosthetic device such as an implant may be received.
  • the socket may be prepared at the desired target location using conventional instruments such as drills, taps, punches or equivalent hole-producing devices.
  • the term "implant” refers to a prosthetic device fabricated from a biocompatible and/or inert material.
  • examples of such "implants” include conventional and knotless anchors of both the screw-threaded and interference-fit variety.
  • the present invention contemplates fabrication of the implant from either a metallic material or a suitable polymeric material, including, but not limited to, polyetheretherketone (PEEK), a polymeric composite such as, for instance, carbon fiber reinforced PEEK (PEEK CF), or of a suitable bioabsorbable material such as, for instance, polylactic acid (PLA).
  • PEEK polyetheretherketone
  • PEEK CF carbon fiber reinforced PEEK
  • PSA polylactic acid
  • the present invention also contemplates the use of very small knotless anchors produced from ceramic materials using a process known as "Ceramic Injection Molding" or simply "CIM".
  • the tensile strength of PEEK material is typically between 10,000 and 15,000 psi. In comparison, the tensile strength of alumina is generally in excess of 200,000 psi.
  • ZTA Zirconia Toughened Alumina
  • Coorstek Inc. Golden, CO
  • ZTA Zirconia Toughened Alumina
  • the high tensile strength and the absence of yielding under load of an implant constructed of such ceramic materials allow torque to be transmitted to the implant through features that are not producible by the machining of metal or that would fail in use if formed from a polymeric material such as PEEK.
  • the implant may take the form of a ceramic interference plug, wherein the high elastic modulus and high strength of the ceramic materials is beneficial for small and miniature interference type anchors that are driven axially into a prepared socket.
  • the high modulus and high strength of the materials allows the thickness of the wall between the central lumen and the outer surface to be reduced compared to interference type anchors produced from polymeric materials without reducing the compressive force which retains the one or more sutures between the outer wall of the implant and the wall of the socket.
  • the preferred implant device of the present invention is comprised of an optionally cannulated tensioning assembly (also referred to as the "inserter” or “insertion assembly”) slidably received within the lumen of a cannulated driver device (also referred to as the implant driver) that together serve to tension sutures in a prepared socket for the placement of a simple one-piece cannulated anchor.
  • a tensioning assembly also referred to as the "inserter” or “insertion assembly”
  • a cannulated driver device also referred to as the implant driver
  • Certain embodiments reference various lock-and-key type mating mechanisms that serve to establish and secure the axial and rotational arrangement of these device components.
  • the implant placement device of the present invention requires a robust connection between the "driver outer assembly” and the associated “implant” or “anchor” so as to ensure that the two rotate as a single unit such that rotational force or "torque” applied to the proximal end of the system (e.g., via the proximal handle portion of the driver device) is transmitted to the distal end of the system (e.g., the distal end of the implant disposed in the prepared socket) without incident or interruption.
  • This continuous “torque transfer” along the length of the system, from proximal to distal end, is critical to the function of the driver, enabling it to distally advance the implant and firmly secure the implant (and any associated sutures or tissues) in the biological site of interest.
  • this continuous torque transfer is achieved by means of coordinating "torque-transmitting" elements, namely a distal “torque-transmitting portion" of the driver device that is configured to mate with and/or conform to a “torque-transmitting” (or alternatively “torque-receiving” or “torque-transferring") portion of the implant, such "portion” including at a minimum the proximal end of the implant though the present invention contemplates embodiments where “torque-transmitting" features on the implant extend along the length of the implant.
  • the respective “torque-transmitting" features on the driver device and implant cooperate to ensure that any proximal torque applied by the user to the proximal handle portion of the device is directly conveyed ("transmitted") to the distal end of the implant.
  • the torque-transmitting portion of the implant may take the form of a laterally extending slot in the proximal end of the implant similar to a standard screwdriver slot; however, other geometries are contemplated and described in detail herein as well as in disclosures incorporated by reference herein.
  • the distal torque-transmitting portion of the driver may also be fabricated from a ceramic material and formed by ceramic injection molding so as to allow miniaturization of the torque-transmitting features.
  • the present invention contemplates securing the graft to the implant via sutures.
  • suture refers to a thread-like strand or fiber used to hold body tissues after surgery.
  • Sutures of different shapes, sizes, and thread materials are known in the art and the present invention is not restricted to any particular suture type. Accordingly, in the context of the present invention, the suture may be natural or synthetic, monofilament or multifilament, braided or woven, permanent or resorbable, without departing from the spirit of the invention.
  • the present invention makes reference to an elongate element of a superelastic and/or shape memory material configured to include a suture retention loop at its distal end and designed to be slidably received within a lumen of a cannulated tensioning device or inserter.
  • the elongate element takes the form of a "nitinol wire".
  • "nitinol” is a super elastic metal alloy of nickel and titanium.
  • the two elements are present in roughly equal atomic percentage (e.g., Nitinol 55, Nitinol 60).
  • Nitinol alloys exhibit two closely related and unique properties: shape memory effect (SME) and superelasticity (SE; also called pseudoelasticity, PE).
  • SME shape memory effect
  • SE superelasticity
  • SE superelasticity
  • SE pseudoelasticity
  • the present invention also makes reference to high strength polymeric materials and high tensile strength ceramic materials, such as alumina or zirconia, that may be formed to complex shapes by a process referred to as Ceramic Injection Molding (CIM).
  • CIM Ceramic Injection Molding
  • ceramic powder and a binder material are molded to a shape that is subsequently fired in a furnace to eliminate the binder material and sinter the ceramic powder.
  • the item is reduced in size by twenty to thirty percent and achieves near 100% density with very high dimensional repeatability.
  • Ceramic materials that are routinely molded and thus contemplated by the present invention include, but are not limited to, alumina, zirconia toughened alumina (ZTA) and partially stabilized zirconia (PSZ).
  • ZTA zirconia toughened alumina
  • PSZ partially stabilized zirconia
  • the flexular strengths of these materials range from 55,000 psi to 250,000 psi, far higher than the 25,000 psi flexular strength of
  • the instant invention has both human medical and veterinary applications. Accordingly, the terms "subject” and “patient” are used interchangeably herein to refer to the person or animal being treated or examined. Exemplary animals include house pets, farm animals, and zoo animals. In a preferred embodiment, the subject is a mammal, more preferably a human.
  • FIGS. 1 and 2 depict a prior art device and method for the placement of a knotless suture anchor.
  • Cannulated driver 100 has a handle portion 102 and a distal hexagonal portion 104 that protrudes beyond anchor 106.
  • Elongate distal portion 114 and proximal hub 116 together form an assembly that is threaded onto an elongate element of driver 100 to which elongate distal element 114 is affixed.
  • Rotating handle portion 102 clockwise as when threading an anchor into a socket while holding proximal hub 116 stationary causes the assembly of hub 116 and distal element 114 to move distally so as to bring anchor 106 to the socket and aid in placing anchor 106 therein.
  • Suture 108 in the cannulation of driver 100 forms a loop at the distal end of distal hexagonal portion 104.
  • sutures 110 which have been passed through graft 112 are positioned within the distal loop of sutures 108 where they are secured against the distal end of distal hexagonal portion 104 by tension applied by the surgeon to the proximal ends of sutures 108.
  • sutures 110 have been drawn into the lumen of hexagonal distal portion 104 of driver 100. Subsequently, sutures 110 are placed under tension by the surgeon so as to enable the positioning of graft 112.
  • distal hexagonal portion 104 of driver 100, along with the sutures 110 is inserted into a prepared socket.
  • tension applied to sutures 110 draws graft 112 to the desired position.
  • anchor 106 is placed in the socket as previously described so as to trap sutures 110 between a portion of anchor 106 and the socket. Placing an anchor using device 100 requires that the surgeon hold hub 116 stationary with one hand while rotating anchor portion 102 with the other hand. An assistant must position the endoscope so that the surgeon can maintain visualization during anchor placement.
  • FIG. 3 Another prior art system 200 for the fixation of a soft tissue graft to a boney surface wherein suture is trapped between a single-piece implant and a wall of a prepared socket is depicted in Figure 3.
  • the system comprises two devices, a driver 210 and a tensioning device 220 that is coaxially positioned within the cannulation of driver 210 during use.
  • Driver 210 has a proximal handle portion 212, and an elongate cannulated distal portion 214 with implant 216 removably mounted to its distal end. Coordinating features on the distal end of elongate distal portion 214 and implant 216 allow torque to be transmitted between driver 210 and implant 216.
  • Cannulated tensioning device 220 has a proximal handle portion 222, an elongate distally extending tubular portion 224 having affixed to its distal end distal tubular element 226. Sutures may be loaded into system 200 using loading wire 232 connected to pull tab 230.
  • tensioning device 210 is coupled to driver 220 so as to prevent axial and rotational movement therebetween.
  • Distal tubular element 226 extends beyond anchor 210 so as to allow tensioning of sutures with distal element 226 inserted into a prepared socket.
  • Removing element 240 decouples tensioning device 210 from driver 220 so as to allow relative axial and rotational motion therebetween.
  • distal element 226 of tensioning device 210 In use, the surgeon inserts distal element 226 of tensioning device 210 into the prepared socket, positions the graft through suture tensioning, removes element 240, and thereafter advances implant 216 to the socket and places anchor 216 by threading it into the socket. Sutures are trapped between implant 216 and the wall of the prepared socket so as to thereby provide suture fixation.
  • Using system 200 requires the surgeon to hold proximal handle portion 222 of tensioning device 220 while removing element 240, and when advancing driver 210 for placement of anchor 216. Assistance is required to hold the endoscope so as to maintain direct visualization.
  • Prior art system 300 is like system 200 in form and function except that proximal handle portion 322 of driver 320 has a distal portion 323 which engages with proximal portion 313 of handle portion 312 of tensioning device 310 such that rotating driver 320 clockwise relative to tensioning device 320 allows driver 320 to move axially.
  • This allows driver 320 to bring implant 316 to a prepared socket as previously described and thread it into the socket so as to trap suture between the outer surface of implant 316 and the wall of the socket.
  • the surgeon must use two hands to place an anchor. He must hold handle 322 of tensioning device 320 stationary while rotating driver handle 312 to uncouple handle 312 from handle 322.
  • An assistant must position the endoscope for direct viewing throughout the process.
  • the tensioning device is maintained in a non-rotating condition by the surgeon's hand on the handle portion of the tensioning device.
  • the surgeon's hand on the tensioning device handle also maintains contact between the distal end of the tensioning device and the bottom of the prepared socket by applying distal force to the tensioning device handle.
  • the surgeon must first uncouple the driver from the tensioning device, then move the driver axially to position the implant at the socket, and must then screw the implant into the socket. This requires the use of both of the surgeon's hands since when doing these actions with the driver, the surgeon.
  • the present invention contemplates performance of these functions with a single hand.
  • a single device performs the tensioning and driver functions of the prior art systems.
  • the tensioning device of previous prior art systems is replaced by a tensioning assembly positioned within the driver device.
  • the forward force for tensioning sutures prior to anchor placement may be supplied by an elastic member like a compression spring that is part of the inner assembly. Rotation of the inner tensioning assembly during anchor placement may be prevented by means within the handle of the driver, or may be prevented by contact between the distal end of the tensioning assembly and the bottom surface of the prepared socket in which the implant is to be placed.
  • Figures 5 through 8 depict driver outer assembly 5500 and implant 5600 for an implant placement device of the present invention configured for one-handed operation by a surgeon.
  • Outer assembly 5500 has a proximal handle portion 5502.
  • Proximal cylindrical recess 5504 extends distally to intersect vertical cylindrical recess 5534 that is configured to receive a slidable control element, the upper portion of vertical recess 5534 being configured to receive retainer 5530 with coaxial opening 5532.
  • Tubular distal element 5510 has affixed to its distal end drive element 5512.
  • Anchor/implant 5600 is removably mounted to drive element 5512 such that torque supplied to drive element 5512 is transferred to anchor 5600.
  • Inner assembly 5400 depicted in Figures 9 through 12 has a proximal hub 5402, and extending distally therefrom elongate tubular element 5410, to the distal end of which is affixed distal tubular element 5412 with distal end 5413.
  • assembly 5450 formed of proximal element 5452 and distal element 5458 with spring 5454 positioned therebetween as depicted in Figure 11.
  • Proximal element 5452 and distal element 5458 are rotatably and slidably positioned on tubular element 5410.
  • element 5456 is affixed to tubular element 5410.
  • Element 5456 has a proximal portion 5476, a middle portion 5470 of reduced diameter forming a circumferential channel bounded by proximal wall 5466 and distal wall 5468, and a distal portion 5472 having a distal end on which is formed chamfer 5474.
  • Figures 13 and 14 depict a slidable control element 5200 configured to be slidably received within vertical cylindrical recess 5534 of handle 5502 of driver 5500, and retained therein by retainer 5530.
  • Control element 5200 has an upper portion 5210 sized to be slidably received within opening 5532 of retainer 5530, a mid portion 5212 and a lower portion 5220.
  • Mid portion 5212 has formed therein symmetrically opposed first (distal) flat 5216 and second (proximal) flat 5214 with cylindrical hole 5218 extending therebetween.
  • the elements of implant placement system 5000 of the present invention comprising outer driver assembly 5500, inner tensioning assembly 5400, and control element 5200 are depicted in Figure 15.
  • Slidable control element 5200 with spring 5230 is inserted into vertical cylindrical recess 5534 and retained therein by retainer 5530.
  • Inner assembly 5400 is inserted into proximal cylindrical recess 5504 and proximal element 5452 is affixed to the proximal end of handle 5502.
  • FIGS 16 through 22 depict implant placement system 5000 assembled in preparation for use.
  • Proximal element 5452 of inner assembly 5450 (see Figure 19) is affixed to the proximal end of outer driver assembly 5500 handle 5502.
  • Control element 5210 is depicted in a first position wherein upper portion 5210 of control element 5200 protrudes above the top surface of retainer 5530 and is maintained in that position by spring 5230. In this first position, distal travel of outer driver assembly 5500 relative to inner tensioning assembly 5400 is constrained by contact between distal facing surface 5466 of proximal portion 5476 of element 5456 and proximal surface 5214 of control element 5210, and initial compression being imparted to spring 5454 thereby.
  • Distal element 5412 of inner tensioning assembly 5400 protrudes beyond implant 5600 a sufficient distance to reach to bottom of a prepared socket while implant 5600 remains proximal to the socket.
  • proximal motion of inner tensioning assembly 5400 relative to outer driver assembly 5500 is prevented by contact between proximal surface 5468 of distal portion 5472 of element 5456 affixed to tubular middle portion 5410, and distal surface 5216 of control element 5210.
  • distal element 5458, washer 5462 and proximal portion 5476 of element 5456 together form a bearing, distal element 5456 and washer 5462 being formed of a metallic material and optionally having a suitable lubricant applied to their mating surfaces as well as on tubular mid portion 5410 of inner tensioning assembly 5400.
  • Implant placement system 5000 places implant 5600 in a method wherein sutures passing through the graft are tensioned using a non-rotating distal tensioning element that protrudes distally beyond the implant a sufficient distance to allow the distal end of the distal tensioning element to reach the bottom of a prepared socket with the implant remaining proximal to the socket.
  • prevention of rotation of inner tensioning assembly 5400 is prevented by cooperative interaction between the distal end 5413 of distal element 5412 of inner tensioning member 5400 and the cortical bone at the bottom of the socket.
  • the consistency of the cortical bone at the bottom of a socket is such that it may be deformed by distal end 5413 of distal element
  • distal element 5412 and by sutures passing into the cannulation of distal element 5412 due to axial force applied by the surgeon.
  • This deformation increases the frictional resistance to rotation of distal element 5412 and inner tensioning assembly 5400 of which it is a part.
  • This resistance to rotation may be further enhanced through the forming of suitable contours on distal end
  • System 5000 has cleats 5408 formed in inner tensioning assembly hub 5402 for maintaining the tension on sutures during placement of the implant. In other embodiments, cleats 5408 are not formed in hub 5402 and the suture tension is maintained through friction between the cortical bone at the bottom of the socket and distal end 5413 of distal tensioning element 5412 between which it is trapped.
  • the tension in the sutures and graft position are maintained by removably storing the suture proximal ends in cleats 5408 of inner tensioning assembly 5400.
  • the tension in sutures 1800 and graft position are maintained by the surgeon applying tension to the proximal ends of sutures 1800, or by friction force applied to the portions of sutures 1800 trapped between distal end 5413 of distal tensioning element 5412 and the cortical bone at the bottom of socket 32, or by a combination of these two methods.
  • a loop of an elongate element such as, for instance, nitinol wire may be formed distal to the distal end 5413 of distal tensioning element 5412 (see Figure 30) with the proximal ends of the elongate element removably secured in cleats 5408 of hub 5402.
  • Sutures may be loaded into the nitinol loop, tensioned, and secured by an anchor, whereupon the elongate element is removed.
  • FIG 28 shows an exploded assembly of the elements of an alternate embodiment implant placement system of the present invention.
  • Implant placement system 6000 is identical in all aspects of form and function to implant placement system 5000 except as specifically described hereafter.
  • cannulated distal tensioning element 5412 of system 5000 is replaced by distal tensioning element 6412.
  • Spring 5230 ( Figure 15) is eliminated such that slide control 6200 may be positioned and remain in a first position in which axial motion of outer driver assembly 6500 is prevented ( Figures 29 through 35), or may be placed and remain in a second position in which the outer driver assembly 6500 may be advanced distally against force supplied by spring 6454 ( Figures 36 through 40).
  • Hub 5402 of inner tensioning assembly 5400 is eliminated, the rotation of inner assembly 6400 being controlled not by the surgeon's hand on a proximal hub, but rather through interaction between the distal end of distal tensioning element 6412 and the cortical bone at the bottom of the prepared socket. Maintaining the position of the distal end of distal tensioning element 6412 at the bottom of the prepared socket is not accomplished through distal force applied to a hub like hub 2402 of the inner tensioning assembly 2400 as when using implant placement system 2000, but rather through distal force applied to handle 6502 of outer driver assembly 6500 and an elastic element acting between inner tensioning assembly 6400 and outer driver assembly 6500.
  • Figures 29 through 35 depict slide control 6200 in a first position with its topmost surface 6201 protruding above the top surface of retainer 6530.
  • distal axial movement of outer tensioning assembly 6500 is prevented by interaction between slide control 6200 and element 6456 of inner tensioning assembly 6400 in the manner previously herein described with reference to implant placement system 5000.
  • Distal tensioning element 6412 has formed thereon distally extending portions 6444 separated by a gap 6446, distally extending portions 6444 having sharpened distal ends 6448, the distal end of distal tensioning element 6412 having the form of a fork.
  • Sharpened distally extending portions 6444 are configured so as to be able to pierce tissue or cortical bone, and gap 6446 is configured so that sutures placed therein may be made to slide smoothly for the purpose of tensioning a graft.
  • Implant placement systems having a tensioning device with a distal end forming a fork are discussed in detail in US 9,566,060 herein included by reference in its entirety.
  • outer driver assembly 6500 of implant placement system 6000 may be moved distally so as to bring implant 6600 mounted thereto to a prepared socket after the position of a graft is established, and subsequently threaded into the socket.
  • Top surface 6201 of slide control 6200 is coplanar with the upper surface of retainer 6530 while bottom surface 6203 of slide control 6500 protrudes beyond the adjacent surface portion of handle 6502 of outer driver assembly 6500.
  • driver assembly 6500 With slide control 6200 in its first position, axial movement of driver assembly 6500 is prevented. With slide control 6200 in its second position driver assembly 6500 rotates freely and may be moved distally relative to inner tensioning assembly 6400, the axial motion being resisted by spring 6454. Slide control 6200 is not returned to its first position by a spring, but rather will remain in its second position until returned to its first position by the surgeon.
  • slide control 6200 of implant placement system 6000 is initially in its first position and the condition of system 6000 is as depicted in Figures 29 through 35.
  • One or more sutures are passed through a soft tissue graft. Thereafter, the sutures are captured in gap 6446 between distally extending portions 6444 at the distal end of distal tensioning element 6412 and inserted with distal tensioning element 6412 into a prepared socket. Thereafter tension is applied to the sutures to bring the graft to the desired position. The surgeon maintains this tension so as to maintain the graft position.
  • Distal force applied to implant placement system 6000 via handle 6502 of outer driver assembly 6500 causes sufficient interference between distal end features of tensioning distal element 6412 to prevent rotation of inner tensioning assembly 6400 during subsequent threading of anchor 6600 into the socket.
  • Compression of spring 6454 of inner tensioning assembly 6400 applies sufficient distal force to ensure that contact is maintained between the distal end of distal tensioning element 6412 and the cortical bone at the bottom of socket 2032.
  • driver assembly 6500 of implant placement system 6000 With slide control 6200 in its first position, axial movement of driver assembly 6500 of implant placement system 6000 is prevented. With slide control 6200 in its second position driver assembly 6500 rotates freely and may be moved distally relative to inner tensioning assembly 6400, the axial motion being resisted by spring 6454. Slide control 6200 is not returned to its first position by a spring, but rather may remain in its second position thereby giving the surgeon the option of inserting distal tensioning element 6412 into a prepared socket and positioning the graft through the adjustment of suture tension while relying solely on the force supplied by spring 6454. The resisting force supplied to outer driver assembly 6500 by spring 6454 is sufficient to allow tensioning of sutures as previously herein described.
  • Driver 6000 is depicted with inner assembly 6400 having distal tensioning element 6412 with its distally extending portion 6444.
  • Inner assembly 6400 may be replaced by inner assembly 5400 with its cannulated distal tensioning element 5412 and hub 5402 without departing from the principles of the present invention.
  • the anchors placed were threaded and placed by torque applied by the driver.
  • the implants placed are interference plug-type anchors (often referred to as "push-in" implants) that are not threaded, but rather are configured for placement in a prepared socket by axial force supplied by the driver.
  • Such implants are well known in the art and have a plurality of axially spaced conical portions formed on their cylindrical outer surface so as to allow ease of placement in the socket, while providing substantial resistance to axial removal.
  • Driver device 7000 configured for the placement of interference plug-type anchor 7600 is depicted in Figures 41 through 42B.
  • Device 7000 is identical in all aspects of form and function except as specifically hereafter described.
  • Distal drive element 7512 has a planar distal face configured for transferring axial force to the planar proximal surface of implant 7600.
  • Implant placement system 7000 is used in the same manner as system 6000 except as subsequently described. The surgeon places implant 7600 with a first hand supplying tension to the sutures for graft positioning, and a second hand, via handle 7502 of outer tensioning assembly 7500, inserting distal tensioning element 7412 into a prepared socket, and thereafter maintaining the position of element 7412 during positioning of a graft.
  • implant 7600 When the graft is properly positioned, implant 7600 is incrementally driven axially into the prepared socket by repeatedly impacting proximal end cap 7452 with a mallet. When implant 7600 is fully inserted, driver 7000 is removed from the site and the repair is completed.
  • distal tensioning elements 6412 and 7412 of driver devices 6000 and 7000 are configured as forks configured for piercing a soft tissue graft, or for providing a channel in which sutures may be slidably retained for the purposes of tensioning the sutures and graft positioning.
  • the distal end of the distal element of the tensioning assembly is optimized for use wherein sutures are retained at the distal end of the tensioning device.
  • Figures 43A through 43C depict distal element 2442 that is alike in form and function to distal elements 6412 and 7412 of driver devices 6000 ( Figures 28 through 40) and 7000 ( Figures 41 through 42B).
  • distally extending portions 2444 has distal portions 2445 that extend medially at their distal ends so that channel 12446 formed between distally extending portions 2444 forms an eyelet having a gap 2447 in its distal end.
  • Some current repair techniques for attaching a graft to a boney surface anchor utilize multiple strands of suture with a single implant. Accordingly, it may be desirable to affix as many as six sutures with a single implant. The length of distally extending portions 2444 may thus be extended thereby increasing the size of channel 2446 to accommodate a desired number of suture strands.
  • resistive force from a spring prevents the tensioning assembly from moving proximally during placement of an implant in a prepared socket following tensioning of a graft.
  • the resisting force is supplied not by a spring, but rather by friction supplied by elements within the implant system. This frictional resistance may be supplied by a single element for which the only function is supplying a resisting frictional force, or by existing elements within the system assembly, or by a combination of the two.
  • Alternate embodiment system 8000 uses frictional force to prevent proximal movement of the insertion/tensioning assembly during implant placement.
  • System 8000 is like system 6000 in all aspects of form and function except as subsequently described.
  • inner assembly 8400 is like inner assembly 6400 ( Figures 9 through 12) except that spring 6454, and associated elements 6458, 6460 and 6462 are eliminated.
  • Friction producing element 8453 is mounted to the distal end of proximal element 8452.
  • Element 8452 supplies frictional resistance to relative movement of the inner tensioning assembly 8400 relative to the outer driver assembly.
  • the friction providing member is integral to proximal element 8452.
  • a discreet element provides frictional resistive force.
  • Distal tensioning element 8412 has affixed to its distal end a resiliently deformable polymeric distal element 8443 affixed to the distal end of element 8442.
  • Distally extending portions 8444 of polymeric distal element 8443 are configured for the retention of sutures therebetween, the distal portions of extending portions 8444 curving inward to form a distal gap 8447 between their distal ends.
  • distally extending portions 8444 are formed of a resiliently deformable polymeric material, maximum width 8445 across portions 8444 may exceed the diameters of the lumen of implant 8600, distally extending portions 8444 deforming inward to allow withdrawal of distal elements 8442 and 8443 from implant 8600 after placement, or for the reinsertion of these elements for implant removal and reinsertion.
  • distal element 8443 is formed of PEEK or a similar resilient polymeric material.
  • distally extending elements 8444 are formed of a super-elastic metallic material such as nitinol.
  • the distally extending portions of the distal end of the distal tensioning element may be rigid, resilient, or elastically deformable, integral with the distal tensioning element or affixed thereto, and formed of a metallic or nonmetallic material. All fall within the scope of this invention.
  • Figures 50 and 51 depict a depth limiting element 2001 formed of a suitable metallic or polymeric material for use with drivers 6000 and 7000 when used for attachment of a soft tissue graft to bone.
  • the force required to insert the graft may be sufficient to cause failure of the graft at the impalement site.
  • the distal end of distal element 3442 may excessively penetrate the graft so as to tear the graft such that the graft slides proximally up distal element 3442 rather than being inserted into the socket.
  • distal element 3442 into the graft may be limited by depth limiting element 2001.
  • element 2001 has formed therein slots 2003 configured for removable mounting to distally extending portions 6444 of distal tensioning element 6412 ( Figure 30) or similar.
  • distally extending portions 3444 protrude distally from slots 3003 of depth limiting device 3001.
  • depth limiting element 3001 prevents tearing of the graft due to over insertion of elements 3444 caused by tension in the graft. Depth limiting element 3001 remains in the construct distal to implant 3600.
  • non-cannulated distal tensioning elements of embodiments previously disclosed have a fork formed at their distal end so that they may be used to pierce soft tissue and/or to retain sutures therein.
  • the two distally extending portions (for instance, 3444 of distal tensioning element 3442) may be replaced by a single distally extending portion.
  • distal tensioning element 4442 has a single, sharpened, distally extending portion 4444 configured for piercing of a soft tissue graft.
  • Depth limiting element 42001 is configured for removable mounting to the distal end of elongate distal element 4442.
  • Distal tensioning element 4442 functions in the same manner as element 3442 previously described.
  • FIG. 58 depicts the steps for a biotenodesis method for attaching a soft tissue graft to a boney surface using a placement device a depth limiting element.
  • Figure 58 depicts the distal portion of the placement device with anchor 4600 removably mounted to distal drive element 4512 with distal tensioning element 4442 protruding distally therefrom.
  • Depth limiting element 4001 is removably mounted to sharpened distally extending portion 4444.
  • Tendon 3020 with whip stitches 3021 is prepared for attachment using socket 3032 in bone 3030.
  • sharpened portion 4444 is inserted into tendon 3020 to depth limiting element 4001.
  • graft 3020 is tensioned and positioned above socket 3032 in preparation for insertion into socket 3032. Thereafter graft 3020 is inserted into socket 3032 as depicted in Figure 61, depth limiting element 4001 ensuring that graft 3020 is not punctured by distal tensioning element 4442 during insertion.
  • implant 4600 has been placed. Thereafter, the placement device is removed leaving the completed repair as shown in Figure 63.
  • implant systems 5000, 6000 and 7000 have been described with reference to placing an implant so as to maintain a graft position by the trapping of sutures between the implant and at least one wall of the socket, these systems may also be used for bio-tenodesis procedures as depicted in Figures 49 through 52, Figures 53 through 57, and Figures 58 through 63 as well as other embodiments contemplated by the present invention.
  • tissue graft anchors by which the surgeon may introduce one or more sutures into a prepared socket in the boney tissue, apply tension to the sutures to advance a soft tissue graft to a desired location, and then advance an anchor into the bone while maintaining suture tension.
  • the present invention addresses this need by providing a system and method for the placement of an implant, especially a suture anchor, threaded, knotless or otherwise, that allows the surgeon to establish the graft position and, while maintaining that position, secure the anchor without changing the suture tension or causing a shift in the graft position and furthermore, when the anchor is threaded, without spinning of the suture.
  • the present invention also provides off-axis socket drills and implant driving devices that enable implantation in remote and difficult to access boney surfaces using minimally invasive procedures.
  • the present invention further provides embodiments in which the relative axial movement between the inner tensioning device and outer driver device is physically constrained, for example by means of springs and the like, so as to allow for one-handed operation.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Système et procédé de mise en place simplifiée pour un dispositif d'ancrage de greffon tissulaire, par lesquels un chirurgien peut introduire une ou plusieurs sutures dans un trou dans un tissu osseux, appliquer une quantité précise de tension sur les sutures de manière à faire avancer un greffon tissulaire mou jusqu'à un emplacement souhaité, puis faire avancer le dispositif d'ancrage dans l'os, en maintenant de préférence la tension de suture requise et sans faire vriller la suture. Des modes de réalisation préférés permettent un fonctionnement d'une seule main. À cet effet, des modes de réalisation dans lesquels un déplacement axial relatif entre le dispositif de mise en tension intérieur et le dispositif d'entraînement extérieur est éventuellement contraint physiquement sont décrits ici. L'invention concerne également des modes de réalisation qui utilisent une boucle de capture de suture "fendue" qui permet la retenue de multiples sutures. Selon d'autres modes de réalisation, l'extrémité distale peut en outre comprendre un élément de limitation de profondeur qui sert à empêcher le dispositif de trop pénétrer, d'endommager ou de déchirer un greffon tissulaire d'intérêt.
PCT/US2017/050222 2014-03-03 2017-09-06 Systèmes de mise en place d'implant et procédés de fixation de tissu à une main faisant appel à ceux-ci WO2018048863A1 (fr)

Priority Applications (2)

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US16/294,663 US11504224B2 (en) 2014-03-03 2019-03-06 Implant placement systems and one-handed methods for tissue fixation using same
US18/057,013 US20230085430A1 (en) 2014-03-03 2022-11-18 One-handed and double row methods for tissue fixation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US15/256,838 US9782250B2 (en) 2014-03-03 2016-09-06 Implant placement systems and one-handed methods for tissue fixation using same
US15/256,838 2016-09-06
US15/429,527 US9907548B2 (en) 2014-03-03 2017-02-10 Implant placement systems, devices and methods
US15/429,527 2017-02-10

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US11311284B2 (en) 2019-03-06 2022-04-26 Speed Clip Solutions, LLC Suture tensioning and securement device, system, and methods

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US6102934A (en) * 1998-06-02 2000-08-15 Li; Lehmann K. Anchor tool and method and apparatus for emplacing anchor in a borehole
US20040193285A1 (en) * 2003-03-28 2004-09-30 Roller Mark B. Implantable medical devices and methods for making same
US20140084522A1 (en) * 2010-03-10 2014-03-27 Greene Manufacturing Technologies, Llc, Dba Britt Manufacturing Surgical needle driver and method of making the same
US20140243892A1 (en) * 2013-02-27 2014-08-28 Arthrex, Inc. Knotless swivel anchor with anchor body advanced over anchor tip
US20140277128A1 (en) * 2013-03-15 2014-09-18 Kurt Hamilton MOORE Ratcheting inserter device and suture anchor arrangement
US20150245901A1 (en) * 2014-03-03 2015-09-03 Tenjin LLC Implant placement systems, devices, and methods

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Publication number Priority date Publication date Assignee Title
US6102934A (en) * 1998-06-02 2000-08-15 Li; Lehmann K. Anchor tool and method and apparatus for emplacing anchor in a borehole
US20040193285A1 (en) * 2003-03-28 2004-09-30 Roller Mark B. Implantable medical devices and methods for making same
US20140084522A1 (en) * 2010-03-10 2014-03-27 Greene Manufacturing Technologies, Llc, Dba Britt Manufacturing Surgical needle driver and method of making the same
US20140243892A1 (en) * 2013-02-27 2014-08-28 Arthrex, Inc. Knotless swivel anchor with anchor body advanced over anchor tip
US20140277128A1 (en) * 2013-03-15 2014-09-18 Kurt Hamilton MOORE Ratcheting inserter device and suture anchor arrangement
US20150245901A1 (en) * 2014-03-03 2015-09-03 Tenjin LLC Implant placement systems, devices, and methods

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11311284B2 (en) 2019-03-06 2022-04-26 Speed Clip Solutions, LLC Suture tensioning and securement device, system, and methods
US12096927B2 (en) 2019-03-06 2024-09-24 Speed Clip Solutions, LLC Suture tensioning and securement device, system, and methods

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