Patent Publication Number: US-2023157707-A1

Title: Device adapted for lateral engagement of an elongated member

Description:
FIELD OF THE INVENTION 
     The present invention relates to devices adapted for lateral engagement of an elongated member with an attachment assembly thereof. More particularly, the present invention relates to surgical devices that are useful in the field of addressing lesions of bone marrow as well as other non-surgical procedures. Such surgical devices are particularly useful in enabling access to extra articular lesions or abnormalities or intra osseous lesions or bone marrow lesions in view of enabling a virtual path and access to an extra articular osseous lesion through intra articular localization. 
     BACKGROUND OF THE INVENTION 
     Surgical procedures to repair bone defects such as lesions or abnormalities typically involve scooping out the damaged tissue material. One such procedure is called curettage. In these procedures, the bone is removed or opened to provide access to the lesion or cancerous tumor. This effectively weakens the bone structure because not only has the damaged tissue been removed, but also some of the load bearing solid bone structure. This is particularly problematic in the spine, the knees and the shoulder and articulating joints. 
     Ideally the surgeon would prefer to attack the problematic tissue without damaging the surrounding load bearing bone tissue. This is particularly difficult, however, because the damaged tissue material to be removed is hidden behind the joint. The current state of the art does not allow for accessing as well as addressing lesions of bone distant to the entry point of the localizing site. 
     The presently available systems and techniques do not adequately address this concern. The present invention described below provides an improved device and associated technique for removing and/or treating the lesion, tumor or other abnormality without damaging the outer joint bone structure, and the surrounding cartilage, and soft tissue. This enables the healing and functionality of the repaired joint to be faster and far less painful. 
     Definitions 
     Bone cement: The bone cement PMMA (polymethylmethyacrylate) starts out as a liquid and hardens over time. It can be put into a hole in the bone in liquid form. As PMMA hardens, it gives off a lot of heat. The heat helps kill any remaining tumor cells. This allows PMMA to be used without cryosurgery for some types of bone tumors. 
     Bone Lesions: Various disorders can damage bones and result in bone lesions. Symptoms include bone pain or tenderness, and the injury can only be seen using special imaging tests. Bone lesions are abnormal areas of bone typically identified using an X-ray or Mill. Lucent bone lesions are caused by rapidly progressing bone injuries. Sclerotic lesions are bone injuries that develop more slowly, which allows the bone to attempt to wall off the damaged bone tissue. Bone lesions typically have cancerous and non-cancerous causes. 
     Bone Marrow Lesions: (BMLs), common osteoarthritis-related magnetic resonance imaging findings, are associated with osteoarthritis progression and pain. 
     Curettage: In this procedure, the doctor scoops out the tumor from the bone without removing a section of the bone. This leaves a hole in the bone. In some cases, after most of the tumor has been removed, the surgeon will treat the nearby bone tissue to kill any remaining tumor cells. This can be done with cryosurgery or by using bone cement. 
     Cryosurgery: For this treatment, liquid nitrogen is poured into the hole that is left in the bone after the tumor was removed. This extremely cold material kills tumor cells by freezing them. This treatment is also called cryotherapy. After cryosurgery, the hole in the bone can be filled by bone grafts or by bone cement. 
     Osteoarthritis: is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage on the ends of your bones wears down over time. 
     Osteochondritis dissecans: (OCD or OD) is a joint disorder in which cracks form in the articular cartilage and the underlying subchondral bone. OCD usually causes pain and swelling of the affected joint which catches and locks during movement. OCD is caused by blood deprivation in the subchondral bone. This loss of blood flow causes the subchondral bone to die in a process called avascular necrosis. The bone is then reabsorbed by the body, leaving the articular cartilage it supported prone to damage. The result is fragmentation (dissection) of both cartilage and bone, and the free movement of these bone and cartilage fragments within the joint space, causing pain and further damage. OCD can be difficult to diagnose because these symptoms are found with other diseases. However, the disease can be confirmed by X-rays, computed tomography (CT) or magnetic resonance imaging (MRI) scans. 
     Subchondral bone: bone located beneath or below the cartilage. 
     SUMMARY OF THE INVENTION 
     Disclosed herein are devices and associated techniques particularly useful for accessing extra articular lesions or abnormalities or intra osseous lesions or abnormalities or bone marrow lesions using intra articular localization has a guide, a locating arm, a set of attachment assemblies and a tubular sleeve. The guide component has a first portion and a second portion. The first portion has a first slotted opening extending a length from a first end. The second portion has an arcuate curvature extending from the first portion to a second end of the guide component with an elongated second arcuate slot in the second portion. The first attachment assembly is configured to be movably adjustable within the length of the first slotted opening. The second attachment assembly is configured to be movably adjustable along the elongated second arcuate slot. The locating arm has a first end and a second end. The second end is configured to be attached to the first attachment assembly. The locating arm has a localizing feature at the first end for defining a virtual pathway that extends perpendicularly to a centerline longitudinal axis of the locating arm. The tubular sleeve is configured to be attached to the second attachment feature. The tubular sleeve is for passing a pin or drill or punch along a selected path to form an entry access. The selected path extends toward the virtual pathway to form the entry access using intra articular localization. 
     The localizing feature at the first end of the locating arm may have any one of a plurality of configurations through which the virtual pathway extends. The first attachment assembly has a knob for tightening the first attachment assembly to the guide component (i.e., a main body). Similarly, the second attachment assembly has a knob for tightening the second attachment assembly to the guide component. Preferably, the first portion is straight and has a scale indicating a location of the first end of the locating arm. The guide component, at the first end, is configured at an open end of the slotted opening to pass onto the first attachment assembly along the length of the slotted opening and when the knob is tightened to set a vertical location of the virtual pathway at the first end of the locating arm relative to an axis of an implement engaged with the second attachment assembly. The locating arm has a shaft having a plurality of grooves. The grooves, when inserted into the first attachment assembly, engage a releasable detent. The detent enters one of the grooves to set an offset distance relative to the location of the virtual pathway and an axis of the drill or the pin or the punch. 
     In one or more embodiments, a surgical device comprises a device body and an attachment assembly mounted on the device body. The attachment assembly includes a main body and at least one closure body. The main body has an elongated recess therein. The elongated recess is configured for receiving an elongated member therein along an entire length thereof. The at least one closure body is rotatably mounted on the main body for enabling the elongated member to be positioned within the elongated recess via lateral movement when the at least one closure body is in a first rotational position relative to the main body and for inhibit the elongated member from being removed from within the elongated recess via lateral movement when the at least one closure body is moved away from the first rotational position toward a second rotational position relative to the main body. 
     In the one or more specific embodiments, the at least one closure body may be coupled to the main body for being rotated about a rotation axis extending one of parallel with and colinearly with a centerline longitudinal axis of the elongated recess. 
     In the one or more specific embodiments, the at least one closure body may have an access passage therein that is aligned with the elongated recess when in the first rotational position for enabling the elongated member to be positioned within the elongated recess and that becomes misaligned with the elongated recess when rotated to the second rotational position for retaining the elongated member within the elongated recess. 
     In the one or more specific embodiments, a closed bottom end of the elongated recess and an open upper end of the elongated recess may be respectively aligned with a closed bottom end of the access passage and an open upper end of the access passage when the at least one closure body is in the first rotational position. 
     In the one or more specific embodiments, the access passage of the at least one closure body and the elongated recess may each be generally U-shaped. 
     In the one or more specific embodiments, the at least one closure body may include two closure bodies each independently mounted on the main body for being rotated about a rotation axis with the elongated recess extending between the two closure bodies. 
     In the one or more specific embodiments, the two closure bodies may be coupled to each other to inhibit relative rotational movement therebetween. 
     In the one or more specific embodiments, the rotation axis may extend one of parallel and colinearly with a centerline longitudinal axis of the elongated recess. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be described by way of example and with reference to the accompanying drawings in which: 
         FIG.  1    is a first perspective view of a guide system device in accordance with an embodiment of the disclosures made herein. 
         FIG.  2    is a second perspective view of the guide system device of  FIG.  1   . 
         FIG.  3    is a third perspective view of the guide system device of  FIG.  1   . 
         FIG.  4    is a fourth perspective view of the guide system device of  FIG.  1   . 
         FIG.  5    is a perspective view of the guide system device of  FIG.  1    having a guide member engaged therewith and a retention assembly of a second attachment assembly thereof in an open configuration. 
         FIG.  6    is an exploded view of the guide system device of  FIG.  1    having a guide member and tubular sleeve engaged therewith and a retention assembly of a second attachment assembly thereof in a closed configuration. 
         FIG.  7    is an exploded view of the guide system device of  FIG.  1   . 
         FIG.  8    is a cross-sectional view of a retention assembly of a second attachment assembly of the guide system device of  FIG.  1   . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIGS.  1 - 8   , a guide component  21  of a guide assembly device (device) in accordance with an embodiment of the disclosures made herein has a first portion  24 A with a first slotted opening  221  for receiving a first attachment assembly  26 A. The first slotted opening  221  is generally straight whereby a longitudinal axis of the first slotted opening  221  extends colinearly with a longitudinal reference axis L 1 . The first attachment assembly  26 A is configured to receive a locating arm  22 , as best shown in  FIGS.  5  and  6   . The locating arm  22  has a first end  22 A and a second end  22 B opposite the first end  22 A. The first end  22 A of the locating arm  22  is fixedly engaged with the first attachment assembly  26 A by suitable means. For example, as shown, the first end  22 A of the locating arm  22  extends through an opening  27  of the first attachment assembly  26 A and an engagement member  226  of the locating arm  22  engages a mating surface of the first attachment assembly  26 A. A centerline longitudinal axis L 2  of the locating arm  22  extends colinearly with a centerline longitudinal axis of the opening  27  of the first attachment assembly  26 A. An arm retention body  227  engages the first end  22 A of the locating arm  22  (e.g., by a mating threaded interface) for securing the first end  22 A of the locating arm  22  in a fixed position with respect to the first attachment assembly  26 A. The arm retention body  227  may be adapted for enabling axial adjustment of the locating arm  22  with respect to the first attachment assembly  26 A (e.g., the engagement member  226  being movably engaged with an elongated member  122 A of the locating arm  22  for enabling selective placement of the elongated member  122 A relative to the engagement member  226 ). 
     A tip portion of the second end  22 B of the locating arm  22  includes a virtual pathway alignment feature which may be a pin having the virtual axis extending through a tip of thereof along a longitudinal centerline axis thereof, a disk-shaped end with an aperture therein or the like. As previously disclosed, a center of the virtual pathway alignment feature (e.g., aperture  32 ) defines a virtual pathway  11 V, in that the virtual pathway  11 V is a perpendicular line passing through the aperture  32  center vertically relative to the locating arm  22 . A localizing pin  30  may be press fit or securely fixed in the aperture  32  whereby the pin  30  may penetrate the tissue to help insure the second end  22 B does not move during manipulation of the guide component  21 . 
     The first attachment assembly  26 A has a knob  28 A (i.e., securing body) for securing a main body  28  of the first attachment assembly  26 A in selected position along a length of the first slotted opening  221 . To this end, the knob  28 A may be in threaded engagement with the main body  28 . For example, the knob  28 A may include a threaded stud that passes through the first slotted opening  221  and into engagement with a mating threaded passage within the main body  28  of the first attachment assembly  26 A. In view of the disclosures made herein, a skilled person will appreciate other various forms of securement arrangements for securing the main body  28  of the first attachment assembly  26 A in a selected position along a length of the first slotted opening  221 . 
     As shown in  FIGS.  1 - 7   , the guide component  21  has a second portion  24  that is arcuately curved. The second portion  24  has a second slotted opening  222  therein. A second attachment assembly  40 B is engaged with the second portion  24  visa the second slotted opening  222 . Such engagement permits movement of the second attachment assembly  40 B along a length of the second slotted opening  222 . The second attachment assembly  40 B may be secured in a desired position along the length of the second slotted opening  222  for enabling the second attachment assembly  40 B to be set at a position corresponding to a desired entry access location of an instrument such as a drill relative to the virtual pathway  11 V, as will be discussed. The second slotted opening  222  preferably has a constant radius of curvature such that when the second attachment assembly  40 A is secured in the fixed position relative to the guide  21 , a tubular sleeve  42  (or other elongated body) can be inserted into the second attachment assembly  40 A. As shown, the second slotted opening  222  of the second portion  24  has a closed end, but this end could alternatively be open and vice versa for the first slotted opening  221  of the first end  24 A. The tubular sleeve  42  may have a manipulation body  42 A engaged therewith for enabling the tubular sleeve  42  to be positioned and rotated relative a subject structure of a patient. 
     As best shown in  FIGS.  1  and  7   , the first slotted opening  221  has graduations  223  associated therewith that identify a location of the first attachment assembly  26 A relative to the guide component  21 . Each gradation  223  preferably has reference location indicia associated therewith. In use, the first attachment assembly  26 A can be shifted upward or downward in the first slotted opening  221  to any desired location at the discretion of the surgeon (e.g., for virtual pathway offset location) and a desired position can be noted based upon location of the first attachment assembly  26 A relative to the graduations  223  and/or associated reference location indicia. Similarly, as best shown in  FIGS.  32 ,  4  and  7   , the second slotted opening  222  has a plurality of graduations  224  associated therewith that identify a location of the second attachment assembly  40 A relative to the guide component  21 . Each gradation  224  preferably has reference location indicia associated therewith. In use, the second attachment assembly  40 A can be shifted along the second slotted opening  222  to any desired location at the discretion of the surgeon (e.g., angle for the entry access relative to the virtual pathway) and a desired position can be noted based upon location of the second attachment assembly  40 A relative to the graduations  224  and/or associated reference location indicia. 
     The second attachment assembly  40 A has a knob  28 B (i.e., securing body) for securing a main body  241  of the second attachment assembly  26 A in selected position along a length of the second slotted opening  222 . To this end, the knob  28 B may be in threaded engagement with the main body  28 . For example, the knob  28 A may include a threaded stud that passes through the second slotted opening  222  and into engagement with a mating threaded passage within the main body  241  of the second attachment assembly  40 A. In view of the disclosures made herein, a skilled person will appreciate other various forms of securement arrangements for securing the main body  241  of the second attachment assembly  40 A in a selected position along a length of the second slotted opening  222 . 
     The second attachment assembly  40 A includes a retention assembly  240 . The retention assembly  240  provides for selective retention and release of a tubular sleeve  42  engaged within an elongated recess  260  of the second attachment assembly  40 A. As shown in  FIG.  6   , a centerline longitudinal axis of a central passage of the tubular sleeve  42  extends colinearly with a longitudinal reference axis L 3  of the elongated recess  260 . The retention assembly  240  permits rotation and axial translation of the tubular sleeve  42  relative to the second attachment assembly  40 A during such retention of the tubular sleeve  42 . Such rotation and axial translation may be manually provided or provided via a powered rotary tool such as, for example, a drill. 
     As shown in  FIG.  5 - 8   , the retention assembly  240  includes spaced-apart closure bodies  242 A,  242 B that each have a mounting portion  243 A,  243 B that is rotatably engaged with a respective mating extension portion  244 A,  244 B of the main body  241  of the second attachment assembly  40 A. Preferably, the closure bodies  242 A,  242 B are coupled to each other to enable synchronous rotate about a rotational axis R 1  when a rotational movement force is applied to a control portion  245 A,  245 B of either one of the closure bodies  242 A,  242 B. The rotational axis R 1  preferably extends one of parallel with and colinearly with a centerline longitudinal axis of the elongated recess  260 . 
     Such coupling may be provided by a coupling member  246  (e.g., a threaded fastener) that is fixedly engaged with both closure bodies  242 A,  242 B for limiting and preferably inhibiting relative movement between the closure bodies  242 A,  242 B. The retention assembly  240  may further include an anti-rotation element  249  that limits unintentional rotation of the closure bodies  242 A,  242 B about the rotational axis R 1 . For example, the coupling member  246  may be a threaded fastener having an O-ring mounted thereon and engaged (e.g., compressedly) with an exterior surface of the main body  241  of the second attachment assembly  40 A whereby friction between the O-ring and the exterior surface of the main body  241  provides friction that limits such unintentional rotation of the closure bodies  242 A,  242 B about the rotational axis R 1 . 
     When the retention assembly  240  is in an open configuration O, each of the access passages  248 A,  248 B is aligned (i.e., suitably aligned or fully aligned) with the elongated recess  260  (e.g., a slot) in the main body  241  of the second attachment assembly  40 A, as best shown in  FIG.  3   . In this aligned configuration, the tubular sleeve  42  (or other elongated body) may be positioned within and removed from within the elongated recess  260  via lateral movement relative to the elongated recess  260  of the second attachment assembly  40 A. For example, the device may be moved in a lateral motion for causing the tubular sleeve  42  to become positioned within or removed from within the elongated recess  260 . Through rotation of the retention assembly  240 , each of the access passages  248 A,  248 B becomes mis-aligned with the elongated recess  260  (e.g., a slot), as best shown in  FIG.  4   , whereby the retention assembly  240  is in a closed configuration C. In the closed configuration C, as best shown in  FIG.  6   , the closure bodies  242 A,  242 B inhibit the tubular sleeve  42  from being removed from within the elongated recess  260  via lateral movement (i.e., retain the tubular sleeve  42  within the elongated recess  260 ) while still permitting axial movement and rotation of the tubular sleeve  42  relative to the main body  241  of the second attachment assembly  40 A. 
     Each of the closure bodies  242 A,  242 B of the retention assembly  240  has an access passage  248 A,  248 B. As shown, the access passage  248 A,  248 B and the elongated recess  260  may each be generally U-shaped—i.e., have a closed bottom end and an open upper end, as best shown in  FIGS.  2 ,  3 ,  4  and  7   . The closed bottom end of the elongated recess and the open upper end of the elongated recess are respectively aligned with the closed bottom end of the access passage and the open upper end of the access passage when the closure bodies are in the first rotational position. An end-view profile of the elongated recess  260  (i.e., as viewed along the rotational axis R 1 ) and a plan view profile (i.e., as viewed along the rotational axis R 1 ) of the access passages  248 A,  248 B may be identical. Alternatively, the plan view profile of the access passages  248 A,  248 B may encompass the end-view profile of the elongated recess  260 . The plan view profile of the access passages  248 A,  248 B is suitably shaped for allowing the tubular sleeve (or other elongated member) to be placed in to the elongated recess  260  via lateral movement when the retention assembly  240  is in the open configuration O. 
     In view of the disclosures made herein, a skilled person will appreciate that the closure bodies  242 A,  242 B located at the opposing ends of the main body  241  of the second attachment assembly  40 A can be replaced by one or more one closure bodies located inboard of the opposing ends of the main body  241 . For example, a single closure body may be rotatably mounted on the main body  241  at or near a mid-point thereof for enabling an elongated member (e.g., the tubular sleeve  42 ) to be side loaded into the elongated recess  260  of the second attachment assembly  40 A with the single closure body in an open configuration and then the single closure body may be moved to a closed orientation (e.g., rotated) for securing the elongated member within the elongated recess  260  of the second attachment assembly  40 A. In preferred embodiments, a length of the single closure body and the length of the elongated recess  260  are jointly configured to limit off-axis skewing of a centerline longitudinal axis of the elongated member relative to the longitudinal reference axis L 3  of the elongated recess  260 . 
     Devices in accordance with embodiments of the disclosures made herein can be used in procedure such as the surgical procedures discussed above. Beneficially, such devices can be utilized in the surgical procedures in a manner that beneficially utilize a virtual pathway and intersecting access pathway provided for by such devices. The ability to laterally position an elongated body (e.g., a tubular sleeve, drill, rod shaped body or the like) within an elongated recess (e.g., a slot) of an attachment assembly of a device and remove it therefrom via lateral movement is advantageous in regard to efficiency and effectiveness of procedures that require the device to be selectively engaged with and/or disengaged from the device during the procedure. For example, in the aforementioned surgical procedures for repairing bony structures exhibiting a lesion or other abnormality, it can be useful to engage the elongated body with the attachment assembly of the device or disengage the elongated body therefrom before or after placement of the elongated body relative to an anatomical (e.g., bony) structure of a patient. 
     A fixture material such as a cement (e.g., bone cement such as PMMA) can be deposited into a cavity through the tube or sleeve  42  for treating or fixing an ailment associated with the cavity. In this regard, devices in accordance with the disclosures made herein may be used in addressing lesions of bone which may or may not be visualized arthroscopically. This could be in situations where the patient has intact articular cartilage, such as the situation with osteochondritis dissecans. The surgeon can tell where the lesion is by probing. There can be situations dealing with osteoarthritis or other lesions of the bone marrow where the subchondral bone is intact. In either case, the surgeon wants to be able to locate where the lesion of the bone is that can&#39;t be visualized, it is essentially extra articular, it is within the bone. This could be termed a bone marrow lesion (BML), but in this technique, the surgeon uses intra articular techniques to access the lesion. 
     In accordance with embodiments of the disclosures made herein, it is highly beneficial to have the capability to first place a tip portion of the elongated body at (e.g., on or within) a desired location of the bony structure, to then securely engage (i.e., side load) the elongated body with the attachment assembly and to then use the device to angularly position the elongated body relative to the bony structure. Such side loading provides for a simplified means of engaging the elongated body with the device in comparison to devices that required engagement over an exposed end portion of the elongated body. Such advantageous operability arises from the capability of sideloading (i.e., lateral engagement) and associated lateral disengagement of an elongated tubular member (e.g., a trocar) fixed in bone vis-a-vis only end loading/disengagement and, in turn, provides for precision of entry point location and target point access, where such entry point location and target point access are each independent of a preset guide device. 
     Devices in accordance with embodiment of the disclosures made herein provide for precise localization of a lesion or other defect and a way to access it while minimizing load bearing bone structure damage caused by the surgical repair by essentially leveraging the inventor&#39;s angled osteal tunnel concept of creating blind tunnels. One example where this technique of use of a device in accordance with embodiments of the present invention is most useful is to access the lesion or other defect from within a knee joint—i.e., intra-articular. A surgeon can position a tip portion of a locating arm of the device from within the knee joint onto or into the bone even going through intact cartilage it necessary. Then, from coming outside of the joint with a drill (or other elongated body), the surgeon can then articulate to a blind spot or point within bone at the location within the lesion or other defect knowing that it is accurate based on the precision of the device i.e., at a point of intersection of the centerline longitudinal axis of the drill and the virtual axis defined by the tip portion of the locating arm. This technique uniquely allows for blind targeting a point or location within bone. 
     Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.