Patent Publication Number: US-2023149062-A1

Title: Self-Drilling Bone Cement Delivery Cannula and Methods for Use

Description:
RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 63/231,869 entitled “Self-Drilling Bone Cement Delivery Cannula and Methods for Use,” filed on Aug. 11, 2021, the contents of which are hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to delivery cannula for use in surgery, particularly in orthopedic applications with bone voids. 
     BACKGROUND 
     Unless otherwise indicated herein, the materials described in this section are not admitted to be prior art to the claims in this application. 
     Many orthopedic medical procedures and treatments for require external and internal bone access to treat bone voids, bone lesions, and bone cysts. A cannula is one way to provide access to these bone voids, bone lesions, and bone cysts. Traditionally, a cannula is placed with trocar and cannula by pushing or hammering into place. The trocar is then removed and the pathway is generated. Problems arise when the cannula is not placed properly via hand or drill. Excessive hand or drilling only can lead to short placement, (i.e. not in the void) or far placement (i.e. past the void). Both of these situations can lead to improper treatment of the void space in the bone. 
     With these problems in mind, it is necessary to provide an instrument that can be placed by hand and or drilled into place directly into the patient’s body. It is also necessary to having both cutting options within a single instrument can provide better control, better placement and better outcomes for the surgeon and patients overall health. 
     SUMMARY 
     In view of the foregoing, the present disclosure provides a device and corresponding method for accessing a treatment area of a bone in a patient. The device is configured to access bone voids within a bone and inject materials into that void. The device will be able to access the void by hand or can be power by a drill. Once in place an autograft, allograft or synthetic bone void graft cement can be injected into the void via the device. 
     Thus, in a first aspect, the present disclosure provides a device including an elongated hollow shaft having a proximal end and a distal end. The device also includes a first attachment mechanism coupled to the proximal end of the elongated hollow shaft. The device also includes a rod having a proximal end and a distal end. The rod is removably positioned at least partially within a lumen of the elongated hollow shaft. The device also includes a second attachment mechanism coupled to the rod between the proximal end of the rod and the distal end of the rod. The first attachment mechanism and the second attachment mechanism are configured to be removably coupled to one another. The device also includes a cap configured to be removably coupled to the second attachment mechanism. 
     In a second aspect, the present invention provides a method for accessing a treatment area in a bone, the method comprising: (i) providing the device of the first aspect, (ii) inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone, (iii) decouppling the first attachment mechanism from the second attachment mechanism, (iv) removing the rod and the second attachment mechanism from the device, (v) injecting a reabsorbable bio-material composition through the lumen of the elongated hollow shaft and into the treatment area in the bone, and (iv) removing the elongated hollow shaft from the treatment area in the bone. 
     These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    illustrates a side view of a device, according to an exemplary embodiment. 
         FIG.  2    illustrates a side view of the elongated hollow shaft and the first attachment mechanism of the device of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  3    illustrates a side view of the rod and the second attachment mechanism of the device of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  4    illustrates a side view of the first attachment mechanism removably coupled to the second attachment mechanism of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  5    illustrates a side view of the distal end of the elongated hollow shaft of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  6    illustrates a side cross-section view of the distal end of the elongated hollow shaft along line B-B of  FIG.  5   , according to an exemplary embodiment. 
         FIG.  7    illustrates a side view of the elongated hollow shaft of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  8    illustrates a side cross-section view of the distal end of the elongated hollow shaft along line E-E of  FIG.  7   , according to an exemplary embodiment. 
         FIG.  9    illustrates a side view of the elongated hollow shaft of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  10    illustrates a detailed view of the distal end of the elongated hollow shaft of  FIG.  9   , according to an exemplary embodiment. 
         FIG.  11    illustrates a detailed view of the proximal end of the device of  FIG.  1   , according to an exemplary embodiment. 
         FIG.  12    illustrates a side cross-sectional view of the proximal end of the device along line E-E of  FIG.  11   , according to an exemplary embodiment. 
         FIG.  13    illustrates a detailed view of the side cross-sectional view of the proximal end of the device of  FIG.  12   , according to an exemplary embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein. 
     Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an exemplary embodiment may include elements that are not illustrated in the Figures. 
     As used herein, “distal” with respect to a portion of the apparatus means the end of the device (when in use) nearer the treatment zone (e.g., the treatment area in a bone) of the subject and the term “proximal” means the portion of the device (when in use) further away from the treatment zone of the subject and nearer the access site and the operator. 
     As used herein, with respect to measurements and angles, “about” means +/- 5%. 
     The present disclosure provides a device and corresponding method for accessing a treatment area of a bone in a patient. The device is configured to access bone voids within a bone and inject materials into that void. The device will be able to access the void by hand or can be power by a drill. Once in place, an autograft, allograft, or synthetic bone void graft cement can be injected into the void via the device. Additional use cases are contemplated as well. 
     With reference to the Figures, the present disclosure provides a device  100  for accessing a treatment area of a bone in a patient.  FIG.  1    illustrates a side view of the device  100 . The device  100  includes an elongated hollow shaft  102  having a proximal end  104  and a distal end  106 . The device  100  also includes a first attachment mechanism  108  coupled to the proximal end  104  of the elongated hollow shaft  102 . In one example, the first attachment mechanism  108  is permanently coupled to the proximal end  104  of the elongated hollow shaft  102 . The combined elongated hollow shaft  102  and first attachment mechanism  108  is shown in  FIG.  2   . 
     As shown in  FIG.  1   , the device  100  also includes a rod  110  having a proximal end  112  and a distal end  114 . The rod  110  is configured to be removably positioned at least partially within a lumen of the elongated hollow shaft  102 . The device  100  also includes a second attachment mechanism  116  coupled to the rod  110  between the proximal end  112  of the rod  110  and the distal end  114  of the rod  110 . In one example, the second attachment mechanism  116  is permanently coupled to the rod  110 . The combined the second attachment mechanism  116  and rod  110  is shown in  FIG.  3   . As shown in  FIG.  3   , the proximal end  112  of the rod  110  extends proximal to the second attachment mechanism  116 . Such an arrangement enables the proximal end  112  of the rod  110  to be used as a drill bit to be inserted in a chuck of a drill, as discuss in additional detail below. As shown in  FIG.  4   , the first attachment mechanism  108  and the second attachment mechanism  116  are configured to be removably coupled to one another. As shown in  FIGS.  1  and  4   , when the first attachment mechanism  108  is removably coupled to the second attachment mechanism  116 , the distal end  114  of the rod  110  extends distal to the distal end  106  of the elongated hollow shaft  102 . Further, as shown in  FIG.  1   , the device  100  further includes a cap  118  configured to be removably coupled to the second attachment mechanism  116 . In one example, as shown in  FIG.  1   , the cap  118  is configured to completely cover the proximal end  112  of the rod  110  when the cap  118  is coupled to the second attachment mechanism  116 . The cap  118  can be removed from the second attachment mechanism  116  independently, resulting in the configuration shown in  FIG.  4   . 
     In one example, the distal end  114  of the rod  110  comprises a drill tip. In such an example, the proximal end  112  of the rod  110  may be coupled to a drill as discussed above to drive the distal end  114  of the rod  110  into the treatment area of the bone. In another example, the distal end  114  of the rod  110  comprises a sharp tip. In such an example, the distal end  114  of the rod  110  may be positioned into the treatment area of the bone via impaction. 
     As shown in  FIG.  1   , in one example an exterior surface of the elongated hollow shaft  102  includes a plurality of distance markings  120 . Such distance markings  120  may be used to ensure that the device  100  is positioned in the proper location in the bone. In particular, fluoroscopy may be used to determine the location of the treatment area of the bone, and the distance markings  120  may be used to confirm that the device  100  is positioned at the appropriate depth in the treatment area of the bone. 
     In one example, as shown in  FIGS.  5 - 10   , the distal end  106  of the elongated hollow shaft  102  includes a plurality of side ports  122 . In use, once the device  100  is positioned at the appropriate depth in the treatment area of the bone, the second attachment mechanism  116  is decoupled from the first attachment mechanism  108  and the rod  110  is removed from the lumen of the elongated hollow shaft  102 . A reabsorbable bio-material composition is then injected through the lumen of the elongated hollow shaft and into the treatment area in the bone. The reabsorbable bio-material composition exits the plurality of side ports  122  to better spread the reabsorbable bio-material composition to the entirety of the treatment area of the bone. In one example, the first attachment mechanism includes a threaded component  124 , and a syringe including the reabsorbable bio-material composition is configured to be removably coupled to the first attachment mechanism  108  via the threaded component  124 . 
     The plurality of side ports  122  may take a variety of forms. In one example, as shown in  FIGS.  5 - 6   , the plurality of side ports  122  comprise angled cutouts. In one particular example, the angle  119  of the angled cutout is about 60 degrees. In another example, the angle  119  of the angled cutout is between about 30 degrees and about 70 degrees. In another example, as shown in  FIGS.  7 - 8   , the plurality of side ports  122  comprise angled circular cutouts. In one particular example, the angle  121  of the circular cutout with respect to the exterior surface of the elongated hollow shaft  102  is about 45 degrees. In one particular example, the angle  121  of the circular cutout with respect to the exterior surface of the elongated hollow shaft  102  is between about 30 degrees and about 60 degrees. In another example, as shown in  FIGS.  9 - 10   , the plurality of side ports  122  comprise straight circular cutouts with sidewalls that are perpendicular to the longitudinal axis of the elongated hollow shaft  102 . Other arrangements of the plurality of side ports  122  are possible as well. 
     The first attachment mechanism  108  and the second attachment mechanism  116  may take a variety of forms. In one example, the first attachment mechanism  108  comprises an integral lock that is activated by a twisting motion between the first attachment mechanism  108  and the second attachment mechanism  116 . In another example, as shown in  FIG.  11   , the first attachment mechanism  108  includes a cavity  126  including a pair of protrusions  128  directed inward from the cavity  126 , and the second attachment mechanism  116  includes a pair of flexible arms  130 . The pair of flexible arms  130  are configured to bend inward as the rod  110  is moved distally within the lumen of the elongated hollow shaft  102  and then snap around the pair of protrusions  128  to thereby removably couple the first attachment mechanism  108  to the second attachment mechanism  116 . To decouple the first attachment mechanism  108  from the second attachment mechanism  116 , the second attachment mechanism  116  is rotated with respect to the first attachment mechanism  108  until the pair of protrusions  128  no longer engage the pair of flexible arms  130 . 
     The cap  118  may be removably coupled to the second attachment mechanism  116  in a variety of ways. In one example, as shown in  FIGS.  11 - 13   , the second attachment mechanism  116  includes a pair of protrusions  132  directed outward, and the cap  118  includes a pair of flexible arms  134  including cutouts  136 . The pair of flexible arms  134  are configured to bend outward as the cap  118  is moved distally with respect to the second attachment mechanism  116 , and the cutouts  136  of the pair of flexible arms  134  are configured to snap around the pair of protrusions  132  to thereby removably couple the cap  118  to the second attachment mechanism  116 . To decouple the cap  118  from the second attachment mechanism  116 , the pair of flexible arms  134  are bent outward and the cap is moved in a proximal direction until the cutouts  136  of the pair of flexible arms  134  no longer engage the protrusions  132 . 
     In operation, the present invention provides a method for accessing a treatment area in a bone, the method comprising: (i) providing the device of the first aspect, (ii) inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone, (iii) decouppling the first attachment mechanism from the second attachment mechanism, (iv) removing the rod and the second attachment mechanism from the device, (v) injecting a reabsorbable bio-material composition through the lumen of the elongated hollow shaft and into the treatment area in the bone, and (iv) removing the elongated hollow shaft from the treatment area in the bone. 
     Such a reabsorbable bio-material composition may be osteoconductive and osteoinductive, thereby enabling new bone growth in the treatment area in the bone. In such an example, the reabsorbable bio-material composition turns to bone to provide bone structure in the bone. 
     In one example, the method further includes rotating the elongated hollow shaft while injecting the reabsorbable bio-material composition. 
     In another example, the treatment area in the bone comprises one of a bone cyst, a bone marrow lesion, or a bone void. A bone cyst is a fluid-filled hole that develops inside a bone. Bone cysts do not usually cause any symptoms, they are not cancerous and they do not usually pose a serious threat to health. Bone marrow lesions (BMLs) or using older terminology “bone marrow edema” is characterized by excessive water signals in the marrow space on magnetic resonance imaging or ultrasound; BMLs constitute a central component of a wide variety of inflammatory and non-inflammatory rheumatologic conditions affecting the musculoskeletal system: BMLs are not only considered significant sources of pain but also linked to increased disease activity in many musculoskeletal conditions (for example, osteoarthritis, rheumatoid arthritis). The bone defects of the above method may be defects of the extremities and/or pelvic bone, as specific examples. 
     In another example, the method further includes removably coupling the first attachment mechanism to the second attachment mechanism, and removably coupling the cap to the second attachment mechanism prior to inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone. In one such example, inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone comprises manually rotatating, via the cap, the distal end of the rod until the distal end of the rod reaches the treatment area in the bone. 
     In another example, the method further includes removably coupling the first attachment mechanism to the second attachment mechanism prior to inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone. In one such example, inserting the distal end of the rod and the distal end of the elongated hollow shaft into the treatment area of the bone comprises: coupling a drill to the proximal end of the rod, and rotating, via the drill, the rod until the distal end of the rod reaches the treatment area in the bone. 
     In another example of the method, injecting the reabsorbable bio-material composition through the lumen of the elongated hollow shaft and into the treatment area in the bone comprises: removably coupling a syringe including the reabsorbable bio-material composition to the first attachment mechanism, and injecting the reabsorbable bio-material composition via the syringe and through the lumen of the elongated hollow shaft and into the treatment area in the bone. 
     While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. 
     Because many modifications, variations, and changes in detail can be made to the described example, it is intended that all matters in the preceding description and shown in the accompanying figures be interpreted as illustrative and not in a limiting sense. Further, it is intended to be understood that the following clauses (and any combination of the clauses) further describe aspects of the present description.