Patent Publication Number: US-11039858-B2

Title: Methods and apparatus for internal hip distraction

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a divisional of U.S. patent application Ser. No. 14/838,723, filed on Aug. 28, 2015, the entire disclosure of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     This disclosure relates to surgical methods and devices for internal joint distraction. In particular, the devices and methods described herein utilize less force and cause less collateral damage than existing joint distraction systems. 
     SUMMARY 
     Disclosed herein are medical devices and methods for internally distracting joints by using minimally invasive distraction. Minimally invasive devices are deployed within a portion of a bone proximal to a bone joint, e.g., in the greater trochanter, and which allow direct force application to the joint to be distracted. The disclosed devices are used in medical procedures for treating/correcting/repairing damage/diseased articular joints, e.g., avascular necrosis of the hip, arthritis in younger people, femoral-cetabular impingements, etc. 
     In an illustrative embodiment, a method of distracting a bone joint is disclosed and includes forming a passage in one bone of a bone joint; arranging an anchor assembly in the passage; and applying a force directly to the anchor assembly to separate and distract the one bone from another bone of the bone joint. An exemplary method includes distracting the bone joint between the femoral head and the acetabulum or the glenohumeral joint. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a suture button anchor assembly, deployed in a transosseous tunnel. 
         FIG. 2  is a perspective view of a suture-anchor anchor assembly, deployed in to transosseous socket. 
         FIG. 3  is a perspective view of anchor assembly suture attached to a force application device of a patient table. 
         FIG. 4  is a side perspective view of the force applicator system for a patient/surgical table that allows the pulling/tensioning vector to be changed. 
         FIG. 5  is a perspective view of an adapter to attaching a force application system to surgical/patient table rail. 
         FIG. 6  is a front perspective view of the surgical/patient table and force application system with a suture from implant loaded onto the hook of the reel/spool device of the force application system. 
     
    
    
     DETAILED DESCRIPTION 
     There is a need for an internal joint distracter and procedures which act to open and close the joint with lower force loads while avoiding peripheral nerve and tissue damage. Disclosed herein are medical devices and methods for internally distracting joints by using minimally invasive distraction. Distraction devices (anchor assembly) as disclosed herein can be used in medical procedures for treating, correcting, and/or repairing damage/diseased articular joints, e.g., avascular necrosis of the hip, arthritis in younger people, femoral-acetabular impingements (a condition where the hip bones have an abnormal shape), or Chondrolysis (gradual degradation of hyaline cartilage in the hip joint), worn or diseased aspects of the bones forming the joint. 
     In a disclosed embodiment, a distraction device is installed within or against a bone of a bone joint and force is applied to the device/anchor assembly to distract the joint bones and separate and space articular surfaces from a joint socket. 
     In a disclosed embodiment, an anchor assembly is secured temporarily within or against a bone of a bone joint and force is applied to the anchor assembly to distract the joint bones and separate and space articular surfaces from a joint socket. 
     In an embodiment, a tunnel is formed and can extend completely through a portion of one bone, and a distraction device is installed in the tunnel. 
     In still a further disclosed embodiment, applying a pulling force to a distraction device distracts joint bones. 
     In a disclosed embodiment for distracting a bone joint, a passage is formed in one bone of a bone joint, an anchor assembly is arranged within the passage, and a force is directly applied to a component of the anchor assembly to separate and distract the bones of the bone joint. 
     In another disclosed embodiment for distracting a bone joint, a tunnel passage is formed in one bone of a bone joint, an anchor assembly is arranged in/within the tunnel passage, and a force is directly applied to a suture component of the anchor assembly to separate and distract the bones of the bone joint. 
     In a further disclosed embodiment for distracting a bone joint, a bone socket is formed in one bone of a bone joint, an anchor assembly is arranged in the socket, and a force is directly applied to a suture component of the anchor assembly to separate and distract the bones of the bone joint. 
     In a still further disclosed embodiment, an anchor assembly for joint distraction is installed in the distal epiphysis of a bone. 
     In other disclosed anchor embodiments, a suture-anchor construct is deployed in the transosseous tunnel/socket, and the suture is externally tensioned to distract the joint. The sutures can be attached to a tensioner on a treatment surgical/patient/table or bed which directly applies tension to the suture. 
     In another disclosed embodiment, the tensioner is a force application system that is capable of five degrees of motion, permit positional adjustable along the x-, y- and z-axes, and angularly and radially. 
     In a further disclosed anchor embodiment, a suture anchor is provided, e.g., the anchor is externally threaded and inserted into the lateral aspect of the greater trochanter. The sutures are then attached to a treatment table or bed with an external tensioning device which directly applies tension to the suture. 
     In one disclosed embodiment, a distraction procedure involves inserting and passing an anchor/button construct which includes a suture/cable through a hole in joint bone and applying force to the suture/cable by a force application device, such as a spool or reel, to directly apply a distracting force to the bone. 
     In another disclosed embodiment, a distraction procedure includes an anchor or button construct with heavy gauge suture or cable, which is passed through a prepared tunnel and affixed to the bone. The suture/cable can be percutaneously removed and attached to a force application system, such as a spool or reel statically mounted to a rail adapter of a surgical/patient table. A handle/crank or other suitable system can be used to rotate the spool or reel in a clockwise or counter clockwise direction to increase or decrease the amount of force applied to the suture/cable. Instead of a user controlled system an automated system can be provided. 
     In a still further disclosed embodiment of a distraction procedure, a tunnel is prepared in a joint bone, an anchor or button construct with heavy gauge suture or cable is passed through the prepared tunnel, the anchor/button is affixed to the bone, and suture or cable is percutaneously removed and attached to a force/tension application device (force applicator), such as a spool or reel statically mounted on a surgical table, such as a Clark rail adapter/clamp, associated with a patient table. 
     In a still further disclosed embodiment, a sheath is inserted into a joint through the greater trochanter via a drilled pilot hole. Then a blunt tipped screw is inserted through that sheath until it reaches the anterior inferior iliac spine on the acetabulum. The screw is twisted in a clockwise direction, and the femoral head is distracted away from the acetabulum. The medical procedure is completed in the joint and the screw and sheath are removed. 
     Another disclosed embodiment is a distraction kit that includes at least one of a first distraction device, a second distraction device and a third distraction device, wherein the first, second and third distraction devices are the same or different, and one distraction device includes a cannulated anchor and force applicator, and the second and third distraction devices include suture anchor constructs. 
     These and other embodiments of the invention will become apparent from the following detailed description when read in conjunction with the accompanying drawings and illustrated exemplary embodiments of the invention. 
     In the following detailed description, reference is made to various embodiments. It is to be understood that other embodiments may be employed, and that structural and logical changes may be made without departing from the scope of the disclosure herein. 
     In  FIGS. 1 and 2  joint distraction utilizing less force and causing less collateral damage than existing joint distraction systems is accomplished by using anchor assemblies that include a suture  50 , e.g., the sutures can be affixed to the bone in any suitable fashion, for example with a button  70  having a first minor dimension sufficient to pass through the tunnel and a second major dimension sufficient to span the tunnel diameter, e.g., BicepsButton™ ( FIG. 1 ), to engage a distal side of the bone so that the joint can be distracted when the suture is pulled. A small transosseous tunnel  100  to pass a suture and suture button combination ( FIGS. 1 and 3 ), or socket  200  for an anchor ( FIG. 2 ) (e.g., a Corkscrew® anchor) is prepared. Suitable drill guides that confer the surgeon the ability to target bones from outside the joint, involving an alignment bar, such as that disclosed in U.S. Patent Publication No. 2014/0276841 or an articulating drill guide, such as that disclosed in U.S. Patent Publication No. 2014/0114322, may be used. The sutures exit percutaneously and are attached to a distraction device, as shown in  FIGS. 3-6 . The distraction device (e.g., cable/suture end of the BicepsButton™ or Corkscrew® anchor) is attached to a bed rail component  300  of a patient table ( FIG. 3 ), or hook  690  and is pulled by a spool or reel mechanism, such as a Clark rail reel mechanism that can be adjusted up/down and/or side by side to achieve ideal distraction angle. 
       FIGS. 4-6  illustrate the force applicator system associated with a surgical/patient table. In  FIG. 4 , force applicator system  600  is secured to a patient table  605  by rail adapter/clamp  615  which can slide onto and along the Clark rail  610 . The system also includes a reel/spool housing  645 , a housing mounting frame  675 , and a platform  635  upon which the frame  675  is located. The frame  675  supports the reel/spool housing  645  for rotation, and the platform supports the frame  675  for both reciprocal and angular repositioning to adjust the force vector for the reel/spool wire/cable. The frame  675  includes a handle  640  which reciprocally slides within a channel on the platform of the frame. 
     The adapter/clamp  615  includes a vertical hole through which post  616  extends. Post  616  is provided with a plurality of equally-spaced holes or openings  617  that allow more manual adjusting of the height of the device (relative to the rail  610 , for example) by the pulling knob  625  that include a shaft (not shown) that can be moved into and out of the openings  617 . Knob  625 , e.g., a height adjustment knob can be of any geometry, round, oval, scalloped, to allow the vertical position of the surgical leg positioning device  100  to be adjusted as needed. 
       FIG. 5  shows the close-up view of the adapter/clamp  615 , which also includes knob  620 , which allows the rail adapter/clamp and post  610  to move axially along the rail  610 . This adjustment can be effected prior to tightening the adapter/clamp  615  by the manual tightening of knob  620  which locks the post and supported components in a desired position. Knob  620  may have a scalloped configuration, for ease of manipulation. Knob  16  allows the rail adapter/clamp  20  to slide along the operating room bed rail  21  until in the desired position and then tightened to secure the rail adapter/clamp  20  in position for securing and unsecuring the rail adapter/clamp from the rail  610  for movement along the surgical/patient table. 
     The platform  635  is located at the top of post  616 . The vertical position of the platform can be adjusted by pulling on knob  625 . Knob  625  includes a cylindrical shaft (not shown) that is positionable within any one of the plurality of holes  617  in post  616  by pulling/withdrawing the knob and moving the platform in the vertical direction. 
     Platform  635  includes upper and lower sections that can rotate relative to one another, and includes a base plate (lower plate or section) that is connected to a rotational positioning plate (upper plate or section) by a swivel lock (not shown) which when loosened by manual/automatic operation, allows the rotational positioning base to articulate with respect to the base plate and to pivot or rotate the frame  675  and housing  645 . Post  615 , described above, are rigidly connected to base/lower plate/section which positions and supports in cantilever fashion rotational positioning upper/base. The rotational base plate, e.g., upper plate, includes open channel  680  for locating therein an arm of the frame  675 . A locking handle  640  extends from a proximal end of the frame arm and permits repositioning movement along the channel. Platform  635  provide for both reciprocating and angular repositioning of the reel/spool housing. 
     Reel  645  of cable  650  is rotatably mounted on platform  635 , and can be rotated or turned via handle  665  which extends from the crank  660 . Any other suitable device, instead of the mechanical-user controlled reel rotation can be used, such as an automated system. In  FIG. 6 , the reel is mounted for rotation within a frame  675 . Wire on the reel is attached to a proximal end of a tether/strap  685 . A hook  690  is arranged at the distal end of the tether/strap  685 . 
     The suture from anyone of the above embodiments can be connected to the hook  690  and the handle-crank rotated to increase tension on the sutures thereby pulling the femoral head out of the hip joint. Rotating the reel/spool in the opposite direction releases tension on the sutures so that the femoral head can return to is natural positon within the hip joint. 
     Although the present disclosure has been described in connection with preferred embodiments, many modifications and variations will become apparent to those skilled in the art. It should be understood that the above disclosure and embodiments therein are exemplary and are not to be considered as limiting.