Patent Application
20160345954
In orthopedic surgical procedures, surgeons attach or reattach soft tissue structures to bone using anchor devices. Difficulties can arise from overly complicated anchor devices and time consuming procedures to implant that can still ultimately result in failure of the attachment.
In one aspect, disclosed is a method of fixing soft tissue to bone. The method includes placing an anchor device superficial to a segment of soft tissue superficially juxtaposed to a unicortical blind hole in a bone, the anchor device having a relaxed state characterized by a first outer dimension. The method includes driving the soft tissue segment into the blind hole using the anchor device. The anchor device transiently constricts to a constricted state during insertion through the blind hole, the constricted state characterized by a second outer dimension that is smaller than the first outer dimension. The method includes trapping a portion of the soft tissue segment between a portion of the anchor device and a portion of the bone when at least a portion of the anchor device is disposed sub-cortically and relaxes towards the relaxed state.
The anchor device can be fabricated from one or more biocompatible polymers. The biocompatible polymers can include Polyetheretherketone (PEEK) and ultrahigh molecular weight polypropylene (UHMWPE). The anchor device can be fabricated from one or more absorbable biocompatible polymers. The absorbable biocompatible polymers can include polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, caprolactone, or a combination thereof. The soft tissue can be a tendon or a ligament.
In an interrelated aspect, disclosed is an anchor device for attaching a soft tissue segment within bone having a body having a distal end region and a proximal end region each at least partially surrounding an interior volume forming a slot extending generally along a longitudinal axis of the body. The anchor device has a concave saddle surface at the distal end region of the body configured to receive and redirect a soft tissue segment extending through the slot in a first direction from the proximal end region of the body to a second direction that is at an angle to the first direction.
The distal end region of the body can be configured to be positioned sub-cortically to a bone defect and at least a portion of the proximal end region of the body can be configured to be positioned intra-cortically within the bone defect. During insertion of the anchor device into the bone defect the body can be configured to transiently constrict from a relaxed state having a first outer dimension to a constricted state having a second outer dimension that is smaller than the first outer dimension. The soft tissue segment can be a tendon or a ligament. At least a portion of the soft tissue segment can be trapped between a portion of the anchor device and a portion of the bone defect when at least a portion of the anchor device can be disposed sub-cortically and relaxes towards the relaxed state. The anchor device can be fabricated from one or more biocompatible polymers, including Polyetheretherketone (PEEK) and ultrahigh molecular weight polypropylene (UHMWPE). The anchor device can be fabricated from one or more absorbable biocompatible polymers, including polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, caprolactone, or a combination thereof.
In an interrelated aspect, disclosed is an anchor device for attaching a soft tissue segment within bone having a cortex and a sub-cortical region having a body having a distal end region and a proximal end region each at least partially surrounding an interior volume forming a slot extending generally along a longitudinal axis of the body. The body is configured to be transiently constricted by a cortical aperture within the bone from a relaxed state having a first outer dimension to a constricted state having a second outer dimension that is smaller than the first outer dimension such that the soft tissue segment is trapped between at least a portion of the body and at least a portion of the bone cortex upon subcortical relaxation of the body towards the relaxed state.
The anchor device can further comprise a concave saddle surface at the distal end region of the body configured to receive and redirect the soft tissue segment extending through the slot in a first direction from the proximal end region of the body to a second direction that is at an angle to the first direction. A pair of opposed prongs can extend from the distal end region of the body on either side of the midline axis and defining the concave saddle surface. The slot can provide a generally c-shaped cross-section to at least a portion of the body. The anchor device can include a proximally-extending cortical feature near the proximal end region of the body, the cortical feature having an arcuate length and cross-sectional size that is smaller than an arcuate length and cross-sectional size of the proximal end region of the body forming a cortical rim retention shelf near the proximal end region of the body. The body can have a tapered sidewall between the cortical rim retention shelf to the distal end region of the body. The cortical rim retention shelf can contract radially around the longitudinal axis when in the constricted state. At least a portion of the anchor device can flex in an arcuate manner when in the constricted state. The cortical rim retention shelf can further include a proximal aspect forming an edge having a plurality of spikes, serrations, or projecting elements. The proximal aspect can capture soft tissue between the proximal end region of the device and at least a portion of bone through which the device is implanted. The body can have monolithic and have a substantially conical or frusto-conical shape. The body can be generally pliable and elastic and have a transverse cross-sectional geometry that is generally arcuate-shaped forming a concave surface and a convex surface to the body. An arcuate length of the transverse cross-section near the distal end region of the body can be shorter than an arcuate length of the transverse cross-section near the proximal end region of the body. When in use within a bored defect within the bone, the distal end region of the body can be positioned within a depth of the medullary cavity of the bone and the proximal end region of the body can be positioned within the bone near a cortical surface of the bored defect. The soft tissue segment can be a tendon or a ligament having an attached end and a detached end. The soft tissue segment can be positioned along the longitudinal axis of the body coursing along both the concave and the convex surfaces of the body such that soft tissue segment is sharply redirected by wrapping around the distal end region of the body and the detached end is compressed between the convex surface of the body near the proximal end region and the cortical surface of the bored defect. The arcuate length of the transverse cross-section near the proximal end region of the body can be greater than a diameter of the bored defect.
In an interrelated aspect, disclosed is an anchor device for attaching materials within bone having a body having a distal end region, a proximal end region, and a plurality of struts extending between the distal end region to the proximal end region and at least partially surrounding an interior volume of the body. The anchor device has an attachment feature positioned within the interior volume of the body and coupled near the distal end region, the attachment feature configured to secure material to the body. Upon removal of a constraint and after delivery of the anchor device into bone, the body passively transitions from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened.
The material secured by the attachment feature to the anchor device can be suture or cable material. The material can be further affixed to a soft tissue structure such as a tendon, ligament, and joint capsule. The attachment feature can be an element such as a suture anchor element, a cleat element, a post, a saddle-shaped element, a pulley, and a crimping element. The attachment feature can include a post extending transverse to the longitudinal axis of the body. The attachment feature can include a saddle shaped element to which the material is secured. The attachment feature can include a cleat element to secure the material. The cleat element can employ a cam action or ratcheting reel assembly to progressively tension the material and approximate the material to the proximal end region of the body. The cleat element can include at least one suture anchor element, two apertures and an intervening central post. A first portion of the material can overlap a second portion of the material resulting in a unidirectional tensioning mechanism of the material with the cleat element. The cleat element can have at least two suture anchor elements, each having an aperture configured to allow the material to extend through. Applying tension to the material can force the at least two suture anchor elements to form a splayed configuration. The tension applied to the material can be maintained by the at least two suture anchor elements. At least a part of the material passed through the apertures of the at least two suture anchor elements and wrapped around the commonly formed post can result in a portion of the material overlapping another portion of the material. The attachment feature can include a crimping element to secure the material. The material can be attached to a soft tissue structure. The material can be secured with an interference pin delivered through an opening in the proximal end region of the body. A proximal aspect of the crimping element can include a cable or suture transecting feature. Any of the anchor devices described herein can include a penetrating tip coupled to the distal end region of the body. The penetrating tip can have a trephine, fluted or conically-tapered outer geometry to facilitate penetration of bone. The material can include a tensioning element configured to approximate the distal end region and the proximal end region upon application of tension on the material causing the plurality of struts to radially expand. The penetrating tip and the tensioning element can be integrated with the attachment feature forming an inner body extending within the internal volume and surrounded at least in part by the body.
The proximal end region can include a discontinuous outer wall defining a proximal opening to the interior volume of the body within which the material is disposed such that soft tissue affixed to the material is in direct contact with the bone. The plurality of struts can expand near the proximal end region to a greater degree than the plurality of struts expands near the distal end region. The body of the anchor device can be fabricated from a superelastic metal. The constraint can include a generally rigid tubular element. The generally rigid tubular element can include a slot to accommodate the material. The constraint can include a circumferential ring element. The circumferential ring element can be positioned between the material and the bone thereby preventing abrasion of the material, the material being suture, cable or soft tissue. The constraint can include a primary constraint and a secondary constraint. The secondary constraint can be positioned over at least a region of the primary constraint during storage of the anchor device.
In an interrelated aspect, disclosed is a suture or soft tissue anchor device having a self-expanding device configured to be constrained prior to delivery having a relatively reduced diameter with a relatively extended length, and subsequently expanded to a relatively larger diameter with a relatively shortened length after deployment and delivery within bone. The self-expanding device can include a generally cylindrical or truncated cylindrical shaped body having two or more slots configured to be constrained prior to delivery.
In an interrelated aspect, disclosed is a suture or soft tissue anchor device configured to employ a self-expanding device that is constrained prior to delivery, in a relatively reduced diameter and relatively extended length, with subsequent deployment and delivery within bone, where it is configured to expand to a relatively larger diameter with a relatively shortened length; in which suture material or cable attached to the soft tissue being approximated or secured to the bone anchor is affixed or otherwise associated with the distal terminus or an element associated with the distal terminus of the anchor.
In an interrelated aspect, disclosed is a suture or soft tissue anchor device configured to employ a self-expanding device that is constrained prior to delivery, in a relatively reduced diameter and relatively extended length, with subsequent deployment and delivery within bone, where it expands to a relatively larger diameter with a relatively shortened length; in which suture material or cable attached to the soft tissue being approximated or secured to the bone anchor is affixed or otherwise associated with the distal terminus or an element associated with the distal terminus of the anchor, such that tension applied on the suture or cable results in a force that foreshortens the length and expands the diameter of the anchor.
The anchor device can be fabricated from a superelastic metal, such as nitinol. A suture can be affixed to a soft tissue structure and secured to the distal end of the self-expanding implant. The soft tissue structure can be a tendon, ligament, or joint capsule. The self-expanding device can be further expanded by means of a tensioning element that approximates the distal and proximal ends of the device. The anchor device can further include a distal tip that is conically tapered to facilitate penetration of bone. The distal tip can be configured with trephine or fluted geometry to facilitate penetration of bone. A suture affixed to a soft tissue structure can be passed through an aperture located distally within the device and delivered through the proximal aperture of the device for subsequent tensioning. A cam action cleat mechanism can be used to progressively tension the sutures and approximate the attached soft tissue element to the proximal aspect of the self-expanding device. A ratcheting reel assembly can be used to tension the sutures and approximate the attached soft tissue structure to the proximal aspect of the self-expanding device. The sutures coursing within the device and attached to a soft tissue structure can be secured to the device with a crimping element. The proximal aspect of the crimping mechanism can include a cable or suture transecting feature. The sutures coursing within the device and attached to a soft tissue structure can be secured with an interference pin, delivered within the proximal aperture. The interference pin can have a tapered distal tip. The cable or sutures restrained by the interference pin can be transected immediately proximal or adjacent to the proximal aspect of the interference pin with a cable or suture cutter having a rotary actuation mechanism.
A generally tubular configured confinement element can be used to maintain the self-expanding device in its confined geometry prior to distal delivery out of the confinement tube and into the bone. The primary confinement tube can have a slot to accommodate introduction of suture material attached to a soft tissue structure. A secondary confinement tubing or ring element can be positioned over the distal segment of the primary confinement tube during storage and can be removed after chilling the self-expanding device immediately or shortly prior to deployment within the bone. A secondary confinement tubing can be positioned over the distal segment of the primary confinement tube during storage and can be removed after chilling the self-expanding device immediately or shortly prior to deployment within the bone.
The device can include at least one suture anchor element having two apertures and an intervening central post, to allow suture to extend through the apertures and around the central post such that a portion of the suture overlaps another portion of the suture, resulting in a unidirectional tensioning mechanism of the suture or cleat mechanism. The device can employ a cam action cleat mechanism to progressively tension the sutures and approximate the attached soft tissue element to the proximal aspect of the self-expanding device. The unidirectional tensioning mechanism can include at least two suture anchor elements, each having an aperture and a commonly formed post comprising at least one post element from each of the at least two suture anchor elements. The suture can be passed through the apertures of the at least two suture anchor elements and wrapped around the common post. The device can include at least two suture anchor elements, each having an aperture configured to allow suture to extend through. Applying tension to the suture can force the at least two suture anchor elements to form a splayed configuration. The tension applied to the suture can be maintained by the at least two suture anchor elements. At least a part of the suture passed through the apertures of the at least two suture anchor elements and wrapped around the commonly formed post, results in a portion of the suture overlapping another portion of the same suture.
In an interrelated aspect, disclosed is a self-expanding suture anchor device having a pre-deployment confined configuration which is at least in part maintained by a circumferential ring element. In the deployed state of the suture anchor device, the device serves to provide a suture abrasion protective function resulting from its surface features and deployment position, located between the suture material and the bone.
In an interrelated aspect, disclosed is an anchor device for attaching tissue within bone having a body having a distal end region, a proximal end region, and a plurality of struts extending between the distal end region to the proximal end region and at least partially surround an interior volume of the body. The body passively transitions from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened upon removal of a constraint on the plurality of struts after delivery into bone. The device includes an attachment feature positioned within the interior volume of the body near the distal end region. The attachment feature is configured to secure the tissue to the anchor device. The device includes a distal penetrating tip. The proximal end region includes a discontinuous outer wall defining a proximal opening to the interior volume of the body within which the secured tissue is disposed so as to be in direct contact with the bone.
In an interrelated aspect, disclosed is a method for anchoring soft tissue. The method includes constraining a self-expanding anchor device within a lumen of a constraining element. The self-expanding anchor device includes a plurality of struts extending between a distal end region and a proximal end region of the anchor device and at least partially surrounding an internal volume of the anchor device. The device includes an attachment feature positioned near the distal end region of the anchor device, and a proximal opening into the internal volume. At least a portion of the plurality of struts is constrained by the constraining element and at least a portion of the distal end region extends beyond a distal edge of the constraining element. The method includes securing a material to the attachment feature and routing the material through the internal volume of the anchor device. The method includes penetrating a bone surface with the distal end region of the self-expanding anchor device until the distal edge of the constraining element abuts the bone surface. The method includes sliding an advancing element relative to the constraining element urging the anchor device beyond the distal end of the constraining element into a subcortical location of the bone surface. The method includes passively expanding the plurality of struts within the subcortical location. The material can include suture or cable. The material can be secured to soft tissue.
In an interrelated aspect, disclosed is an implantable fixation device formed at least in part of temperature affected shape set material that transitions from a geometrically confined configuration to an expanded configuration. The device is constrained to the confined configuration at ambient storage temperatures by a removable element. The removable element is removed after the temperature affected shape set material is chilled immediately prior to delivery into the body.
The removable element can be generally tubular. A secondary confinement tubing or ring element can be positioned over a distal segment of the removable element during storage. The secondary confinement tubing can be removed after chilling the self-expanding device immediately or shortly prior to deployment within the bone. The implantable fixation device can be an implantable soft tissue fixation device. The proximal end region can further include a plurality of serrations extending from a proximal edge of the device. A proximal end region of the device can further include a plurality of serrations extending from a proximal edge of the device. The plurality of serrations can capture soft tissue between the proximal end region of the device and at least a portion of bone through which the device is implanted.
In an interrelated aspect, disclosed is a suture or soft tissue anchor assembly having an anchor device with a plurality of self-expanding stays extending between a proximal end region and a distal terminus and surrounding an internal volume. A soft tissue material extends through the internal volume and loops over the distal terminus of the anchor device. The soft tissue material is approximated or secured to the anchor device at the distal terminus such that tension applied on the soft tissue material causes a force that foreshortens the length and expands the diameter of the anchor device.
The proximal end region of the device can further include a plurality of serrations extending proximally from a proximal edge of the device. The plurality of serrations can capture the soft tissue material between the proximal end region of the device and at least a portion of bone through which the device is implanted. The internal volume can extend an entire length of the anchor device from the proximal end region through the distal end region. The assembly can further include a cap covering an outer wall at the distal end region of the device. The cap can include a surface edge that is broader than a bare edge of the outer wall. The cap can be configured to support and redirect the soft tissue material looped over the distal terminus. The cap can be formed of a material that is softer than the material of the outer wall. The cap can be a polymeric material. The cap can further include one or more ridged surfaces. The one or more ridged surfaces can be oriented in a direction that is transverse to a longitudinal axis of the internal volume through which the soft tissue material extends. The one or more ridged surfaces can be configured to increase surface friction between the soft tissue material and the device to reduce soft tissue migration relative to the distal terminus.
In an interrelated aspect, disclosed is an anchor device for attaching materials within bone having a body having a distal end region, a proximal end region, and a tapered sidewall between the distal end region and the proximal end region. The body defines a bore extending along the body from the distal end region to the proximal end region. The anchor device includes a soft-tissue directing feature at the distal end region of the body configured to direct a soft-tissue that extends through the bore in a first direction to a second direction at an angle to the first direction. The body of the anchor device is contracted from an initial configuration to a delivery configuration in which an external diameter of at least a portion of the body is reduced, and return to the initial configuration upon release.
The anchor device can be contracted radially of the body. The anchor device can be contracted in an arcuate manner. At least the portion of the body can have a c-shaped cross-section with an interrupted outer wall portion. The interrupted outer wall portion can have an interruption that is dimensioned to control a maximum reduction in the diameter of the body. The anchor device can further include a soft-tissue confinement feature at the distal end of the body and adjacent to the soft-tissue directing feature. The soft-tissue confinement feature can be configured to confine the soft-tissue that passes through the bore of the body and directed by the soft-tissue directing feature. The soft-tissue confinement feature can include a pair of opposed prongs extending at the distal end of the body. The anchor device can include a soft-tissue compression collar at the proximal end portion of the body. The anchor device can include a retention shelf near the proximal end portion of the body. The tapered sidewall can taper from the retention shelf to the distal end portion. The retention shelf can include the portion of the body that is reduced when contracted. The anchor device can include a soft tissue-compression collar at the proximal end portion of the body, adjacent the retention shelf. The retention shelf can further include one or more ridging surfaces. The one or more ridging surfaces can be arcuate. The soft-tissue directing feature can include one or more ridging surfaces to increase friction with the soft-tissue. The body can be monolithic and can have a substantially conical shape. The tapered sidewall can include one or more scalloped features. The body of the anchor device can be configured to flex generally along a longitudinal axis of the body.
In an interrelated aspect, disclosed is a system for securing tendon to bone having a pliable and elastic body having a transverse cross-sectional geometry that is generally arcuate-shaped forming a concave and a convex surface to the body. The body has a generally orthogonally-oriented long axis extending between a distal end and a proximal end. An arcuate length of the transverse cross-section near the distal end is shorter than an arcuate length of the transverse cross-section near the proximal end. When in use within a bored defect within a bone, the distal end of the body is positioned within a depth of the medullary cavity of the bone and the proximal end of the body is positioned within the bone near a cortical surface of the bored defect. The system includes a tendon positioned along the long axis of the body coursing along both the concave and the convex surfaces of the body such that the course of the tendon is sharply redirected by wrapping around the distal end of the body while a segment of a detached end of the tendon is compressed between the convex surface of the body near the proximal end and the cortical surface of the bored defect.
The body can have a generally hemi-frusto-conical geometry. The anchor system can further include distally projecting elements forming a lateral confining element within which the tendon courses around the distal end of the body. The arcuate length of the proximal end of the body can be greater than a diameter of the bored defect. A transverse arcuate wall thickness of the body can be non-uniform. The transverse arcuate wall thickness can be greater near a margin than in a central region. The body can be composed of elastomeric material such as PolyEtherEtherKetone (PEEK) polymer or Nitinol alloy.
In an interrelated aspect, disclosed is a pliable and elastic device for securing tendon to bone that is configured to be driven into a cortical cancellous bore initially resulting in radial contraction and arcuate hinging of the device through a region of the cortical bone with subsequent relaxation of the device in a region of subcortical bone.
A diameter of a portion of the proximal subcortical arcuate segment of the device can be greater than a diameter of the cortical bore through which the device is inserted. The device can be composed of elastomeric material such as a PEEK polymer or Nitinol alloy.
In some variations, one or more of the following can optionally be included in any feasible combination in the above methods, apparatus, devices, and systems. More details of the devices, systems and methods are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings.
These and other aspects will now be described in detail with reference to the following drawings. Generally speaking, the figures are not to scale in absolute terms or comparatively but are intended to be illustrative. Also, relative placement of features and elements may be modified for the purpose of illustrative clarity.
It is to be understood that implants described herein may include features not necessarily depicted in each figure.
During at least some orthopedic surgical procedures, surgeons can attach or reattach soft tissue structures to bone via suture material. A suture anchor device can provide a way for anchoring to the bone, such as cortical or cortical cancellous fixation. Fixation can be provided by an implant having interference fit, (e.g., with the tendon compressed between the implant and the bone) or a thread, suture or cable attachment form. Alternatively, fixation of the implant can be achieved by radial and/or implant hinge expansion within the subcortical cancellous bone. It is also proposed that a combination of radial/hinge expansion and tendon or ligament compression can be employed, as is utilized in some implementations of this invention. The expansion can occur beyond the cortical defect through which the implant was inserted such that pull-out of the implant is resisted.
Described herein are devices, systems and methods of use to provide a rapid, easy and reliable way to anchor sutures or soft tissues such as tendon, ligament or joint capsule to bone. Implementations of the anchor devices described herein are simple to deploy in that they are either constricted on insertion, self-expanding, or both, and do not require active expansion. In a preferred implementation of the tendon anchor that does not utilize suture fixation, the anchor devices described herein can be constricted during deployment, and once deployed, return to an initial size without additional expansion. The anchor devices described herein allow for better vascular growth and more surface fixation, than other marketed devices that are less porous or shield the attached soft tissue from adjacent bone. The anchor devices described herein minimize the strangulation of the soft tissue to be affixed or the trapping of the soft tissue between rigid parts of the anchor device or the bone channel. The anchor devices described herein can saddle and redirect the soft tissue to be affixed within the interior volume of the device while still allowing for direct intimate contact of the soft tissue with the bone to which it is being affixed thereby promoting bone and soft-tissue attachment to the secured tissue.
In some implementations, the anchor device 10 can have a long axis A, defining a generally tubular or cylindrical body geometry to the anchor device 10 immediately prior to insertion and delivery. The long axis A can have a proximal end that can be superficial in location and a distal end that can be deep in location with respect to the patient's bone surface or cortex. The proximal end of the anchor device 10 can be tapped such as with or through a deployment tool to force the sharp distal tip 30 through bone material. The proximal end of the anchor device 10 can also be pushed to urge the anchor device 10 through a pre-drilled hole.
In some implementations, the outer body 15 of the anchor device 10 can be self-expanding. The outer body 15 can be fabricated from super-elastic shape memory metal, such as Nitinol. Prior to deployment, the struts 20 of the outer body 15 can be constrained by an implant deployment tool (for example, like the tool 800 shown in
As shown in
Other configurations of the attachment feature 40 are considered herein, such as those described in
Additionally, each of the suture anchor elements 502 can include at least one aperture 506 that can allow suture 510 or a pliable suture passing component, to pass through. This can allow for a variety of methods of securing suture 510 to the suture anchor elements 502 and the anchor device 10. For example, the suture 510 can be fixed to the attachment feature 500 by passing at least a part of the suture 510 through the proximal aperture 50 of the anchor device 10 and into the interior cavity (including following deployment of the device). In addition, at least a part of the suture 510 can be routed through the aperture 506 of at least one of each of the suture anchor elements 502 (see
The suture 510 routed through the proximal aperture 50 of the anchor device 10 (as seen in
As shown in
The attachment feature 500 of the device can be surrounded by the slotted tubular body 514 (see
In addition, a loop on the suture 510 can be used to pull suture material or cable 830 that has been previously associated with soft tissue (e.g. tendon, biceps tendon, posterior tibial tendon, rotator cuff), through the suture anchor device along its routed path in the deployed or expanded position of the implant. The soft tissue structure can be pulled through the suture anchor device once the anchor has been inserted into the bone and deployed into an unconstrained configuration (as shown in
As shown in
With the perimeter struts 20 fully deployed (see
In some implementations, the opposing internal surface features 57, 58 of the crimping element 55 can interdigitate with closure, providing for optimized friction lock of the suture strands 35 and central tensioning element 45 within. The surface features 57, 58 can additionally include opposing sharp proximal edges that either meet or overlap in a scissoring manner, resulting in division of the suture strands 35 and central tensioning element 45 at a tip of the crimping element 55 and most proximal aspect of the tubular body 15. The internal bore of the proximal aspect of the tubular body 15 of the anchor device 10 can have a conical geometry that can match the geometry of the external surface of the crimping element 55 in the crimped configuration. The crimping element 55 can also include a side slot for capturing the suture strands 35 within the crimping element 55 from the side.
In an implementation of deployment, a suture strand(s) 35 can be placed through a tissue or other material that is intended to be approximated to bone. The “free” suture ends 35 can be passed by way of suture passers (such as by wire cable or synthetic cable coursing along the intended course of the sutures within the device) that are pulled or tensioned along with the attached free ends of the suture 35 within the device deployment tool. With the sutures 35 secured to the device deployment tool 800, the pointed tip 30 of the anchor device 10, which can extend distally beyond the distal end of the constraining element, can be delivered along a soft tissue path that minimizes the potential for a soft tissue bridge (i.e. superficial soft tissue that is trapped between the tensioned suture strands and the bone). This can be accomplished with a variety of strategies, such as using an introductory cannula or by placing tension of the sutures 35 with one of the surgeon's hands and then sliding the delivery shaft and anchor device 10 immediately adjacent and along the axis of the tensioned suture strands 35 with the other hand.
Once the anchor device 10 is delivered into close proximity to the bone's cortical surface to which the suture strands 35 are intended to be approximated, the sharp distal tip 30; which might include a trocar geometry and/or very sharp tip, can be tapped through the cortex or pushed through a pre-drilled hole. The anchor device 10 and device deployment tool 800 can be advanced until the distal edge 818 of a constraining element 810, which can have a larger diameter than the cortical defect or channel through which the distal tip 30 has been advanced, is positioned up against the outer cortex of the bone (see, for example,
Once delivered within the subcortical location, the anchor device 10 may be radially expanded via a passive process mediated or effected by the shape memory properties of the superelastic metal alloy of the struts 20. This can be followed by active tensioning of the suture leads until the suture is optimally tensioned and the attached tissue is sufficiently approximated to the devices cortical entry location. Tensioning of the suture leads can be accomplished with a variety of mechanisms, including opposing cam configured cleats or a ratcheting reel mechanism. In an implementation, the tensioning of the suture 510 and radial expansion of the struts 20 is accomplished via the unidirectional tensioning feature of the dual aperture and common post cleat elements, such as described above in reference to
A crimping element 55 (shown in
A cutting tool or cutting feature can be situated at the upper end of the crimping element 55 can be used subsequent to the crimping or trapping of the tensioned suture 35 and tensioning element(s) 45 to cut the cable elements of the suture and tensioning element(s). The device delivery mechanism can be separated due to suture and central tensioning amputation from the delivered, deployed device, and approximated tissue. In an implementation, the suture 510 may be cut via a rotating blade element within a deployment tool's shaft, which can also be in close proximity to the proximal aperture 50 of the anchor device 10.
The anchor devices described herein can be deployed using passive, self-expanding deployment and include a pre-deployment confined configuration. In some implementations, the confined or constrained configuration can be at least in part maintained by a circumferential ring or tubular element. While the suture anchor device is in a deployed state, the circumferential ring element can provide a suture abrasion protective function resulting from one or more of a variety of surface features and deployment positions (i.e., located between the suture material and the bone).
It should be appreciated that the anchor devices described herein can be deployed using passive or active deployment or a combination of the two. In some implementations, the plurality of struts 420 passively transition from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened. The anchor device 400 can include a self-expanding super-elastic shape set material, such as nitinol, that prior to deployment is maintain in a constrained configuration having a reduced diameter along a segment of its length that passively radially expands with deployment within the internal confines or medullary cavity of the bone. The anchor device 400 can rely solely upon the properties of the shape memory, super-elastic material (e.g. nitinol) to spontaneously revert (once unconfined) to a radially enlarged configuration with deployment. The anchor device 400 described herein can undergo initial passive deployment for provisional fixation in the bone channel and then active tensioning for full and final expansion. The passively deployed expansion can be purely within the subcortical region of the bone.
In some implementations, the anchor device 400 can be configured to anchor soft tissues 405 (see
The anchor device 400 can position the soft tissue 405, such as a tendon to be affixed, within the interior volume 445 of the highly porous body (for example, by virtue of the plurality of slots 417 and struts 415) of the expanded device 400 while providing for intimate contact with the cortical cancellous bone 401. The tendon or soft tissue 405 to be affixed can be secured to the anchor device 400 via a cable or suture 404 that is weaved through the soft tissue 405 and then tied or otherwise secured to the distal end region 410 of the anchor device 400 (see
Loads imparted by tendon tensioning can be high and as such sufficient wall thickness and deployed rigidity are desired to overcome loads imparted by tendon tensioning and to prevent the anchor device 400 from collapsing through the small cortical defect through which it is inserted. The anchor device 10 described above may have substantially thinner device walls compared to anchor device 400 (or anchor device 600 described below) to facilitate active expansion using the central tensioning element.
A soft tissue 405, such as a tendon terminus, can initially be positioned and secured, through the proximal aperture 450 and into the bore or internal volume 445 of the body 415 (see
The attachment feature 430 can be positioned within the internal volume 445 of the body 415 for example near the distal end region 410 (e.g. the end of the anchor device 400 that is first introduced through the bone 401) and can be configured to secure the tissue 405 to be attached to the bone 401 to the anchor device 400. The attachment feature 430 can include a post, slot, pulley, cleat, crimping element or other element as described herein to facilitate securing or coupling of materials such as a suture material and/or a soft tissue 405 to the anchor device 400. In some implementations, the attachment feature 430 can include a saddle shaped element to which at least two suture ends 404 can be passed around and subsequently knotted or crimped to secure the tendon 405 associated with the suture 404 within and/or to the anchor device 400 (see
Once secured to the anchor device 400, the soft tissue 405 and the anchor device 400 can be delivered from the exterior surface 480 of the bone 401 through an appropriately sized and fashioned channel 408 or cortical defect (e.g. a drill hole sized to near the diameter of the tendon-device construct into the medullary cavity or internal canal of the bone 401) (see
The struts 420 can be asymmetrically configured, such that when the device is deployed and the struts 420 expand radially from the long axis A of the anchor device 400, tensioning on the attached soft tissue 405 can result in off axis (i.e. tilting) displacement of the device, providing enhanced resistance to undesired displacement and “explantation” of the device and tendon from the bone's medullary cavity. In some implementations, the struts 417 can be shaped such that they have non-uniform wall thickness. For example, the struts 417 can be thinner near a central region and thicker near the distal and proximal ends. In other implementations, the struts 417 can have a reduced wall thickness where the struts couple to a ring-like structure that constrains the struts 417 and keeps the anchor device 400 in the reduced diameter configuration. The outer surface of the anchor device 400 can have a generally constant external diameter.
The anchor devices described herein, once implanted, can be put under a tensile load along the longitudinal axis A of the device. The tensile loads applied along the longitudinal axis A to the anchor device when in use can further approximate the distal end region to the proximal end region and result in further expansion of the struts away from the longitudinal axis A. Thus, the tensile load can act to further anchor the anchor device within the bone. In some implementations, suture or cable can be weaved through a detached tendon end that is being attached or repaired into the bone. The suture or cable can be tied or otherwise fixed to an attachment feature near or at the distal end of the device. As the tendon is placed in tension via muscle action or any other effect (e.g. elbow extension with the biceps tendon), the tension is transmitted to the distal end region of the device where the suture or cable material is attached. This tensile loading of the tendon and attached suture or cable maintains the anchor in the expanded configuration in which the distal end of the device is approximate to the proximal end of the device. The proximal end of the device is restrained in that the expanded struts are located immediately deep to the smaller diameter cortical defect. Thus, the device is kept compressed as a result against the deep surface of the cortical bone and the struts are in the deployed or expanded configuration.
The anchor devices described herein can also provide for limited contact with the surface features of the reattached soft tissue to optimize the biological repair process, for example, vascular and collagen repair within the bone to the tendon. In some implementations, the generally tubular geometry of the anchor devices described herein (at least in the constrained configuration) can be circumferentially disrupted along a segment of its proximal length while preserving circumferential continuity distally such that direct contact can occur between the soft tissues such as a tendon terminus and the adjacent tissues for optimal biological repair.
As best shown in
The devices described herein can be sterile packaged and confined in a delivery tube, with or without suture passers that can be employed to facilitate delivery of the suture strands (securely attached during surgery to the tendon) through the channel or aperture of the device and around the distal terminal post or saddle. A slot in the confining tubes distal end can accommodate the introduction of the tendon terminus. A small ring or grommet can be employed to maintain hoop strength of the confining delivery tube and serve to reduce abrasion after implantation of the tendon against a sharp external cortical edge.
A sizing guide can be used to determine the optimized size for the cortical defect (e.g. drill hole) needed to provide for intimate contact of the exposed tendon's surface with the cortical margin. The defect can be slightly undersized relative to the cross-section or diameter of the tendon-device construct such that with introduction, the compliance of the tendon can provide for annular constriction of the tendon within the cortical defect. This can be facilitated by tightly winding an implantable low friction monofilament suture material around the delivery tube and tendon secured to the device prior to delivery. The low friction monofilament material can temporarily constrict and confine the tendon to a reduced cross-sectional geometry and with deployment introduction remain superficial to the bone (allowing for its removal) allowing the tendon to relax back into a geometry of larger cross-sectional area within the medullary cavity.
In another implementation of deployment, a constraining tube element with or without a disruption of the circumferential continuity of the constraining element can be further surrounded by a secondary confinement element to reinforce the inner constraining tubing element in its ability to constrain the self-expanding device in its reduced diameter, constrained geometry. The constraining element can have a disruption of the circumferential continuity, as in a distal longitudinal slot feature (e.g. to accommodate suture introduction and delivery to the confined device), or a thin walled constraining tube that alone and at room temperature would be insufficient to constrain the outward expanding forces of the constrained self-expanding device. A secondary constraining ring or tube can be maintained around the inner constraining tubular element to reinforce the constraining effect. The distal tip of the device can be chilled prior to removing the secondary external ring or tube, immediately or shortly prior to deploying the self-expanding device.
The outward displacing forces of the shape set material within a thin walled and/or slotted tubing may exceed the circumferential restraining strength of the constraining tubing (i.e. hoop strain resulting in deformation of the tubing or splaying). An alternative accommodation can be to provide sufficient restraint at room temperature storage of inventory or above to avoid thicker walled tubing confinement. The concept relies upon the two different material states of the differing material properties of the superelastic metal in the martensitic state and the austenitic state, as well as the properties within the transformational temperature range (i.e. from A s (Austenitic start) temperature to A f (Austenitic finish) temperature) for the expandable material composition of the device. In the Martensitic state, nitinol is relatively pliable and it is not superelastic. While in the Martensitic state at lower temperatures, it has a relatively low modulus of elasticity (compliant), while in the fully austenitic state it is superelastic and it has a relatively high modulus of elasticity (stiff).
It is proposed the relatively thin walled and/or slotted constraining tubes that house the superelastic self-expanding shape set device can be additionally constrained by an encircling larger diameter tubing (plus or minus circumferential in configuration, but in a preferred implementation, circumferential), during inventory storage and transport of the device. Immediately prior or just prior to surgical application (e.g. within the preceding day, hours, or minutes) the device and in particular the components of the shape set superelastic material can be brought to a reduced temperature (relative to ambient) to condition the material in the transformation temperature range (e.g. refrigerated or immersed in a chilled or ice bath). With the material in the transformation zone temperature range, the most outer constraining tubular element can be removed, providing for adequate constraint from the thin walled and/or slotted tubing due to the reduced outwardly expanding force exerted by the chilled shape set and only partially superelastic material. For commonly used nitinol material this can be in the temperature range from −4 degrees Fahrenheit to 50 degrees Fahrenheit.
In addition it is contemplated the constraining elements either or both might have thermally insulating material disposed about their surfaces or as a coating to retard the warming effects of exposure of the chilled implant/delivery device once the most exterior constraining element has been removed. Once delivered, the implant can be warmed by local body heat or heated by various means (e.g. irrigation with warmed physiologic solutions) to facilitate transformation into the shape set superelastic state. The most external constraining element or tube can be associated with the device only during storage and can be removed or pulled off the distal tip of the device after bringing the devices shape set material to a lower than ambient temperature with various chilling means (e.g. refrigeration or chilling bath) while in the immediate operative setting or immediately prior to surgery. This can allow for the use of a thinner walled and/or slotted constraining tube immediately surrounding the nitinol during surgical delivery. An implementation of the previously described variant includes the use of a physiologic solution to warm the deployed device to promote expansion in situ.
The plurality of struts of the devices described herein can provide the body with a defining perimeter having various shapes. The shape of the expanded anchor device can vary depending on the region in which the anchor device is expanded. Generally, the plurality of struts expands outward from the longitudinal axis A of the device such that they take on a curved or otherwise bowed shape. The plurality of struts can bow radially outward from a central axis A of the anchor device such that the perimeter of the expanded anchor is generally conical in shape. Each of the struts can expand to a greater extent near the proximal end region of the device compared to the distal end region of the device (see, for example,
As described herein, the surface geometry of the anchor devices can be generally discontinuous such that a plurality of slots defines the plurality of struts. The width of the plurality of slots can vary resulting in variable widths of each of the plurality of struts. Further, the number of the slots and thus, the number struts can vary. The struts can be made thicker or thinner to achieve a particular strength for a particular purpose. Further, the thickness of each of the struts can vary along their length such that a portion near a distal end region or a proximal end region is thicker than a centrally disposed portion of the strut. Each of the struts can have a wider, more flattened configuration or can have a more rounded wire-like configuration. The wall thickness and width of the struts can be uniform or non-uniform.
As described above the anchor devices described herein can be configured to anchor soft tissues such as tendon or other tissue to or within a rigid material such as cortical bone. Some anchor devices include one or more attachment features that facilitate securing or coupling of materials to the anchor device (see, e.g. attachment feature 40 shown in
The anchor device 600 can be used to deliver and secure a generally cylindrical segment of a detached tendon's terminus within a closely confining bore or channel of bone 601. As with other implementations of anchor devices described herein, the anchor device 600 can provide for limited contact with the surface features of the reattached soft tissue to optimize the biological repair process. As will be described in more detail below, cradling the soft tissue 605 to be affixed within the highly porous architecture of the device 600 approximates the soft tissue 605 to the bone 601 in a manner that limits the compression of the soft tissue 605 against the cortical rim and affords abundant opportunity for vascularization of the soft tissue 605 as well as fibrous and boney attachments to the perimeter of the soft tissue 605.
The body 615 can in its constrained configuration be generally cylindrical having a plurality of slots 617 extending through the wall of the body 615 forming the plurality of struts 620. The plurality of slots 617 can be generally shorter in length than the overall length of the body 615 such that an outer wall 618 can be formed at the distal end region 610 of the body 615 and an outer wall 619 can be formed at the proximal end region 612 of the body 615.
The outer wall 619 at the proximal end region 612 of the body 615 can form or define the proximal opening 650 into the internal volume 645 of the body 615. The outer wall 619 at the proximal end region 612 of the body 615 can be discontinuous forming a gap such that in cross-section it defines a generally c-shaped proximal opening 650 to the internal volume 645. Upon deployment of the anchor device 600, the discontinuous proximal outer wall 619 can be positioned near or within the bone channel through which the anchor device 600 was delivered (see
The proximal end region 612 of the device 600 can form an edge having a plurality of serrations 685. When in use, the serrations 685 can be adjacent to the region in which the soft tissue 605 is compressed between the implant 600 and the cortical bone 601 (see
The distal end region 610 of device 600 can be open such that the internal volume 645 extends the entire length of the anchor device 600 between the proximal end region 612 and the distal end region 610. The soft tissue 605 can extend clear through the entire length of the internal volume 645 and loop around the distal end region 610. The distal end region 610 of the device 600 can include a cap 687 covering the outer wall 618. The cap 687, like the distal outer wall 618 of the body 615, can be c-shaped in cross-section such that one side of the cap 687 is open and the opposite side of the cap 687 forms a surface against which the soft tissue 605 can fold over when it loops around the distal end region 610. As best shown in
The cap 687 can extend distal to the distal outer wall 618 of the body 615 forming a notch 686 (see
The anchor device 1900 can include a proximally-extending cortical feature 1905. The cortical feature 1905 is configured to be positioned at least in part within a cortical defect 2308 of bone 2320 and the body 1915 is configured to be positioned subcortically. The body 1915 together with the cortical feature 1905 defines a slot 1960 extending from a proximal end region of the device 1900 to a distal end region of the device 1900. The presence of the slot 1960 provides a generally C-shape or arcuate cross-sectional geometry to at least a portion of the body 1915, and/or both the cortical feature 1905 and the body 1915 of the device 1900. The c-shaped cross-section can be dimensioned to control the outer dimension achieved in the constricted state of the device during insertion into a bone defect. The arcuate length and cross-sectional size of the cortical feature 1905 can be smaller than the arcuate length and cross-sectional size of the proximal end region of the body 1915 such that a cortical rim retention shelf 1910 is formed near the proximal end region of the device 1900. The relationship between the cortical rim retention shelf 1910 and the cortical feature 1905 can create an offset that serves to trap and redirect the soft tissue structure under the cortical margin of the bone bore 2308. The body 1915 can taper from the cortical rim retention shelf 1910 to the distal end region, forming a substantially hollow, generally conical or frustoconical shaped device having a tapered side wall 1920 (see
As with other implementations of anchor devices described herein, the anchor device 1900 can provide for limited contact with the surface features of the reattached soft tissue to optimize the biological repair process. The slot 1960 can allow a soft tissue structure 2310 (such as a tendon or other soft tissue to be attached to bone) to pass through and be accommodated within the body 1915, for example, while suspending the soft tissue structure 2310 within the intramedullary canal for subsequent healing. Again with respect to
The anchor devices described herein need not incorporate a plurality of radially expanding stays or struts to secure the anchor device with the medullary cavity of the bone as described above and as shown in the implementations of
The flexibility/resiliency of the anchor device 1900 can be provided in various ways. For example, the monolithic structure of the anchor device 1900 can be provided with a degree of flexibility/resiliency through a flexible/resilient material and/or a non-uniform wall thickness of the circumferential configuration of the C-shaped body 1915 allowing its maximum diameter to be reduced during insertion into a comparatively smaller defect. The body 1915 can be formed of an elastomeric material or combination of materials, such as polyetheretherketone (PEEK) polymer, ultrahigh molecular weight polypropylene (UHMWPE), Nitinol alloy and others. The transverse arcuate wall thickness of the body 1915 can be non-uniform. The transverse arcuate wall thickness can be greater near one or both of the margins compared to a central region. The body 1915 can include one or more scalloped features 1921. The scalloped features 1921 can have a variety of shapes and sizes, but are generally relatively shallow features disposed longitudinally along the body 1915. The scalloped features 1921 can be located equidistant from the lateral edges or sides of the implant. The scalloped features 1921 can reduce the wall thickness in portions of the body 1915. The interruption provided by the scalloped features 1921 can be dimensioned to accommodate (and/or to control) the desired reduction in diameter during flexure to facilitate the insertion of the anchor device into the cortical defect. The scalloped features 1921 can also prevent molded polymer part “sink” or retract from its molded dimensions.
As mentioned above, the cortical rim retention shelf 1910 near the proximal end region of the device 1900 can be configured for deployment deep to the cortical rim of a cortical defect 2308 through which a soft tissue structure 2310 is to be fixated. In some implementations, the cortical retention shelf 1910 can be configured with an external geometry that is a segment of a circumference corresponding to a radius that is larger than the radius of the cortical defect 2308 through which the device 1900 and a soft tissue structure 2310 are to be inserted. As such the arcuate length of the proximal end of the body 1915 can be greater than a diameter of the bored defect 2308. As the device 1900 is inserted into the defect 2308 and the C-shape undergoes flexure and hinging, the proximal aspect of the shelf 1910 can return towards its resting state upon passing distally beyond the rim of the cortical defect 2308 leaving at least a portion of the cortical feature 1905 within the defect 2308 (see
The proximal aspect of the cortical rim retention shelf 1910 can form an edge having a plurality of spikes, serrations, or one or more projecting elements 1985 (see for example
As mentioned above, the device 1900 can also include a proximal cortical feature 1905 extending proximal to the cortical rim retention shelf 1910. Where the cortical rim retention shelf 1910 is configured to be inserted within the sub-cortical region, at least a portion of the cortical feature 1905 remains positioned within the defect 2308. The proximal cortical feature 1905 can have an external surface 1903 configured to trap the divided or detached end of the tendon or soft tissue structure 2310 against a surface of the defect 2308. In some implementations, the external surface 1903 of the cortical feature 1905 can be configured with a geometry that corresponds with a radius that is equal to or slightly smaller than the cortical defect 2308 through which the device 1900 and the looped soft tissue segment 2310 are inserted. At least a portion of the external surface 1903 of the cortical feature 1905 can provide compression of the soft tissue between the anchor device 1900 and the internal cortical rim of the cortical bone defect 2308 once the device 1900 is implanted.
In some implementations, the cortical feature 1905 can also include a pair of cortical interference fit extensions 1907. The extensions 1907 are located on a region of the cortical feature 1905 extending away from the external surface 1903 configured to compress or trap the detached end of the tendon (see
As shown in
The devices and methods of soft tissue fixation to bone described herein can reduce the burden of surgical repair while optimizing the biological conditions for healing by providing an efficient surgical method. The method can include placing the device 1900 superficial to a segment of soft tissue 2310 superficially juxtaposed to a unicortical blind hole or defect 2308 in a bone 2320 (see
The anchor devices described herein can be constructed of one or more biocompatible materials. In some implementations, one or more portions of the anchor devices, such as the struts, are formed of a biocompatible memory-shaped alloy (e.g. Nitinol, titanium/nickel alloy, nitinol wire mesh) with or without radiolucent material (e.g. PEEK®, Victrex Corp., PolyEtherEtherKetone, or other polymer material). One or more portions of the anchor devices described herein can be formed of ultrahigh molecular weight polypropylene (UHMWPE), Nitinol alloy and others. The anchor devices described herein can be fabricated from absorbable biocompatible polymer(s) such as polyglycolic acid (PGA), and/or polylactic acid (PLA), polydioxanone, and caprolactone. Use of both radiodense and radiolucent elements within the devices provide enhanced mechanical performance while affording improved radiologic monitoring. The anchor devices described herein can incorporate a region composed of bias ply or meshed material (e.g. polymer strand, or wire strand). The struts can be manufactured by laser cutting a nitinol tube as is known in the art. The tubular device can also be manufactured of a material including platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, rhenium, nickel, cobalt, stainless steel, Nitinol, and alloys thereof.
The soft tissue structure anchored by the anchor devices described herein can vary. In some implementations, the soft tissue structure is a tendon or a ligament. The anchor devices described herein are particularly suited for use in percutaneous procedures or for use in arthroscopic procedures, including but not limited to biceps tendon, posterior tibial tendon, other relatively narrow and cylindrical tendon repairs, rotator cuff surgery, tendon and ligament affixation or repair, prosthetic attachment, and the like. The anchor devices described herein can be used in any procedure in which it is desired to fix a suture or a soft tissue to a solid object.
While this specification contains many specifics, these should not be construed as limitations on the scope of what is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.
In the descriptions above and in the claims, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.
This application claims priority under 35 U.S.C. §119(e) U.S. Provisional Patent Application Ser. No. 62/167,191; filed May 27, 2015, entitled “Anchor Devices and Methods of Use,” and U.S. Provisional Patent Application Ser. No. 62/232,295; filed Sep. 24, 2015, entitled “Anchor Devices and Methods of Use,” which are incorporated by reference herein in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 62167191 | May 2015 | US | |
| 62232295 | Sep 2015 | US |
