Abstract:
A surgical apparatus. The apparatus includes a handle structure, a shaft structure coupled to the handle structure, and a spreading structure coupled to the shaft structure and movable between a compact and an expanded configuration. The apparatus includes a protective sheath of shape-recovery material. The protective sheath covers the entire spreading structure in a substantially form fitting manner in any configuration of the spreading structure including the compact configuration, the expanded configuration and any configurations therebetween.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 10/861,865 filed on Jun. 7, 2004, which is a continuation-in-part of U.S. application Ser. No. 10/389,818, filed Mar. 18, 2003 which claims priority to U.S. Provisional Application Ser. No. 60/365,026 filed Mar. 18, 2002. The disclosures of the above applications are incorporated herein by reference. 
    
    
     INTRODUCTION 
     The present teachings relate to a surgical apparatus for use in orthopedic surgery procedures. Particularly, the present teachings relate to the treatment of traumatic, pathogenic, or osteoporotic bone conditions of human and other animal body systems and, more particularly, to a novel apparatus and method for manipulating the vertebral body through a less invasive, percutaneous, surgical approach. 
     Surgical procedures frequently require that after surgical entry has been made the tissues within the patient&#39;s body must be expanded away from the surgical point of interest in order to provide better access and visibility for the surgeon. Various surgical devices have been developed to assist the surgeon to displace tissue and expand the interior cavities of the body during both open surgical procedures and less invasive surgical procedures. 
     Surgical procedures vary dramatically depending upon the region of the body involved and the purpose of the surgery. The design and the use of surgical instruments are equally specialized and instruments which seemingly are intended for similar purposes can be significantly different from one another depending upon the exact nature of the surgery. The use of retractors to expand an opening or create a space to facilitate access for the surgeon during the performance of a surgical procedure is well known in the art. It is, however, often the case that one tissue retractor designed for use in a particular surgical procedure will be completely unsuitable for retraction of tissue in a different type of surgery. 
     Conventional surgical procedures, which have been employed to alleviate vertebral compression failures, involve major invasive surgical techniques with all of the possible negative consequences. The close proximity of the spinal cord to damaged sections of a vertebra, which are in need of surgical repair, presents a particularly hazardous situation for the patient and increases the challenge for the surgeon tremendously. Recent surgical innovations have been made that provide a means of reinforcing damaged vertebra by the injection of bone cement into the vertebral body. However, in patients suffering from crippling effects of osteoporosis and the possibility of compression fractures of multiple vertebrae, there remains a need for an effective and safe way to distract the vertebral endplates so as to alleviate the compressed disposition of the vertebral body. Such a specialized requirement dictates the need for a specialized tissue expansion device. Numerous tissue expansion devices have been developed for different surgical procedures including tissue retractor used to expand a body wall entry incision. For nearly a century such retractors with one or more specialized modifications have been used to meet the particular requirements for body wall incision expansion in different surgical procedures. Other tissue manipulators or expanders include an inflatable balloon as the mechanical device to expand the skin around a surgical entry site. Balloon-type expansion devices are uncontrolled and multi-directional, which can lead to undesirable expansion of the bone or bone fragments being displaced in unwanted directions 
     Conventionally used tissue expansion devices are each configured to precisely meet the specific needs for particular surgical procedures and, as such, are not readily (if at all) adaptable to meet the needs of a different surgical procedure. 
     Conventional devices share the common problem of possibly suffering mechanical interference or fouling of the mechanism when tissue or bone come into contact with the internal mechanism of the devices. Such fouling of the mechanism by involvement with tissue or bone during the insertion process, expansion process, or the retraction process can severely limit the effectiveness of such a device. Each possibility presents a unique problem for the surgeon using an unprotected manipulating device, such as, for example, if the mechanism becomes fouled or occluded during the insertion process, it may fail to operate once it is properly in place. Similarly, it is possible that during operation of the expansion mechanism, the exposed mechanism can become occluded and thus limit or fully stop the expansion process. Finally, if the unprotected mechanism is fouled or hung-up on tissue or bone during the retraction or removal process, the removal may be impeded so as to require additional surgical procedures to successfully extract the device. 
     The present teachings provide a less invasive surgical device, which can be precisely controlled by the surgeon to expand tissue and transmit sufficient force to manipulate bone in a selected direction or, if desired, in multiple directions. Further, the present teachings provide a device that protects the mechanism from unwanted contact with surrounding tissues, where such contact might result in occlusion or fouling of the mechanism such that the function of the device is compromised. 
     SUMMARY 
     The present teachings generally provide a device designed for use as a less invasive means of controllably manipulating a damaged bone, and in particular a patient&#39;s vertebra to create a void therein so as to enable a surgeon to accomplish a surgical procedure while providing a protective member on the mechanism to avoid undesirable contact with surrounding tissue and bone. 
     The present teachings provide a surgical apparatus that includes a handle structure, a shaft structure coupled to the handle structure, and a spreading structure coupled to the shaft structure and movable between a compact and an expanded configuration. The apparatus includes a protective sheath of shape-recovery material. The protective sheath covers the entire spreading structure in a substantially form fitting manner in any configuration of the spreading structure including the compact configuration, the expanded configuration and any configurations therebetween. 
     Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
    
    
     
       DRAWINGS 
       The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. 
         FIG. 1  is a cross-sectional plan view of a first embodiment of the device of the present teachings, which shows the mechanism configured in an expanded position; 
         FIG. 2  is a cross-sectional plan view of a first embodiment of the device of the present teachings, which shows the mechanism configured in a closed position; 
         FIG. 3  is an isometric view of the mechanical detail of the modular spreading assembly of a second embodiment of the present teachings in the expanded position; 
         FIG. 4  is an isometric view of the mechanical detail of the modular spreading assembly of the embodiment of the present teachings of  FIG. 3  shown in the closed position; 
         FIGS. 5A-C  show plan, top and end views of the modular spreading assembly of the embodiment of the present teachings shown in  FIGS. 3-4 ; 
         FIG. 6  is an isometric view of an alternative handle assembly of the present teachings; 
         FIGS. 7A-B  show a side and end view of a third embodiment of the device of the present teachings in a closed (A) and open (B) position; 
         FIGS. 8A-B  show a side and end view of a fourth embodiment of the device of the present teachings in a closed (A) and open (B) position; 
         FIG. 9  shows a protective sheath enclosing another alternative embodiment of the spreading assembly of the present teachings; 
         FIG. 10  shows another alternative embodiment of the handle assembly of the present teachings; and 
         FIGS. 11A-11C  show three non-limiting, alternative examples of a knob-type handle assembly for use with the present teachings. 
     
    
    
     DETAILED DESCRIPTION 
     The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. 
     The apparatus and method of the present teachings can be adapted for use in a variety of surgical procedures which require precise tissue manipulation by a surgeon. The following description and associated  FIGS. 1-11C  are provided as non-limiting examples of the present teachings, which is defined with particularity only by the claims of the present teachings. 
     As shown in  FIGS. 1-10 , a tissue manipulation device ( 10 ) is provided. In one aspect, the device is configured to be particularly well-suited to the manipulation of bone in a subject. By way of example, the device ( 10 ), as best shown in  FIGS. 1-9 , includes three portions or assemblies which can be integrally formed or separately fabricated prior to being joined to form the device ( 10 ). 
     The three assemblies, which together form the device ( 10 ), include a handle assembly ( 12 ), a shaft assembly ( 14 ) and a spreading assembly ( 16 ). A proximal end ( 18 ) of the shaft assembly ( 14 ) is connected to the handle assembly ( 12 ) and a distal end ( 20 ) of the shaft assembly ( 14 ) is connected to the spreader assembly ( 16 ). 
     As earlier indicated, these three assemblies ( 12 ,  14 ,  16 ) can be integrally formed or, alternatively, can be individually formed and then connected to form the whole device ( 10 ). It is also within the concept of the present teachings for the one or more of the assemblies to be releasably connected one to the other. 
     In an embodiment where the three assemblies ( 12 ,  14 ,  16 ) are formed and subsequently permanently connected one to the other, the connections may be of any character known for connecting parts of a whole into one unit, to include, for example: gluing, soldering, welding, mechanically joining by rivets or screws or the like or any other means for permanently connecting parts one to the other. 
     If the three assemblies ( 12 ,  14 ,  16 ) are releasably attached one to the other, any releasable attachment means known can be used, to include, for example: snap fittings, bayonet fittings, luer lock fittings, threaded fittings, cotter-pin connections, plug and socket connections, or any other releasable attachment means. If the device ( 10 ) is integrally formed, any manufacturing process known can be employed, to include extrusion molding, die-casting, tooling, or any other means of fabricating such a device. 
     When the device ( 10 ) is configured to permit releasable attachment of the three assemblies ( 12 ,  14 ,  16 ) to each other, it is possible for the user to attach alternative embodiments of any of the three individual assemblies ( 12 ,  14 ,  16 ). This feature of the present teachings permits each of the three assemblies ( 12 ,  14 ,  16 ) to separately have specifically designed embodiments that are configured for very specific uses or for individual preferences of the using surgeon. Thus, one embodiment of the device ( 10 ) enables the user to customize the combination of the three assemblies ( 12 ,  14 ,  16 ) to meet the particular requirements for a specific surgical procedure. 
     As best shown in  FIGS. 1-2 , the handle assembly ( 12 ) can be configured to operate as a scissor-like embodiment so as to provide ease of handling by a user during operation of the device ( 10 ).  FIG. 1  provides a depiction of the scissor-like embodiment of the handle assembly ( 12 ) in the device-open configuration while  FIG. 2  depicts this embodiment in a device-closed configuration. It is within the concept of the present teachings to reverse the operable effect of the handle positions shown in  FIGS. 1 and 2  without departing from the concept of the present teachings. The scissor-like embodiment of the handle assembly ( 12 ) depicted in  FIGS. 1 and 2  can include a first handle member ( 22 ) and a second handle member ( 24 ), each handle member ( 22 ,  24 ) having respectively a connecting end ( 26 ,  28 ) and a gripping end ( 30 ,  32 ). 
     Each of the connecting ends ( 26 ,  28 ) is movably connected one to the other by a handle member connector ( 34 ). In one aspect, the handle member connector ( 34 ) is configured as a handle member pivot pin ( 36 ) although the handle member connector ( 34 ) can be configured as rotationally engaged portions of the first and second handle members ( 22 ,  24 ). Thus, the handle member connector ( 34 ) can be configured to include a pivot pin ( 36 ), a rotating ball-and-socket joint, a rotating rim-and-groove joint, or any other connection design which permits the connecting ends ( 26 ,  28 ) of the first and second handle members ( 22 ,  24 ) to be connected in a moveable relationship one to the other. The first and second handle members ( 22 ,  24 ) can be biased into a closed or open relationship one to the other by a biasing member ( 38 ), which can be releasably attached to facilitate repair and replacement. 
     The handle members ( 22 ,  24 ) can define an actuating arm portal ( 40 ) which provides for an arm anchor ( 42 ) defined within the second handle member ( 24 ). The portion of the portal ( 40 ) defined through the first handle member ( 24 ) can be sized and configured to hold and restrict the movement of an actuating arm sleeve ( 44 ). The shaft assembly ( 14 ) includes the actuating arm sleeve ( 44 ) and the actuating arm ( 46 ). The actuating arm sleeve ( 44 ) can be sized and configured to permit sliding passage of the actuating arm ( 46 ). The actuating arm ( 46 ) at its proximal end ( 48 ) can be releasable attached to the actuating arm anchor ( 42 ). Both the actuating arm ( 46 ) and the actuating arm sleeve ( 44 ) are configured to be in a sliding relationship, one within the other, and to be of a respective fixed length such that the actuating arm ( 46 ) can slide to a position which extends beyond the distal end ( 50 ) of the sleeve ( 44 ). 
     Attached at the distal end of the actuating arm ( 52 ) is a spreading assembly ( 16 ). The spreading assembly ( 16 ) can be sized and configure to fit within the sleeve ( 44 ) when the actuating arm ( 46 ) is fully withdrawn into the sleeve ( 44 ). The spreading assembly ( 16 ) can be releasable from the actuating arm to permit the surgeon to insert the spreading assembly into a bone, actuate the spreading assembly into an expanded position, and, if desired, disconnect the spreading assembly so as to permit it to be left within the bone. This optional releasable feature of the spreading assembly ( 16 ) also permits the device to be configured with different sizes and configurations of spreading assembly prior to use. 
     The spreading assembly ( 16 ), as best seen in  FIGS. 3 ,  4 , and  5 A-C, can be configured to include at least one extending arm ( 56 ) that can be in pivotal relationship at one end with the actuating sleeve ( 44 ). Any sufficiently strong material compatible for use in surgical instruments can be used in the manufacture of the device. The extending arm ( 56 ) can be manufactured of a rigid material to provide strength and reliable, consistent performance during operation. Conventional spreaders, which can include flexible sleeves, are incapable of providing the even, consistent force during operation that is essential for safely manipulating bone material. This especially important when manipulating the end plates of a vertebral body. At least one bracing member ( 58 ) is rotationally attached at one end to the actuating arm ( 46 ) and rotationally attached at the other end to the proximal end of the extending arm ( 56 ). Due to the operational requirement of manipulating bone, the bracing member can be manufactured of rigid material, however any material suitable for use in surgical instruments can be used if sufficiently strong. In operation, when the actuating arm ( 46 ) is extended distally beyond the confines of the sleeve ( 44 ), the bracing member ( 58 ) serves to exert a force on the extending arm ( 56 ) so as to force the spreading assembly into an open position. A locking mechanism can be provided so as to releasably lock the spreading assembly into position. This locking mechanism can be configured as a notch, slot, or other like means to fix the spreading assembly into an open position. The locking mechanism can be selectively locked or unlocked. 
     To facilitate smooth operation of the spreading assembly ( 16 ), a guide bar ( 60 ) sized and configured to slidably move with the confines of a guide slot ( 62 ) can be provided. The guide slot ( 62 ) can define the forward most and reward most movement of the guide bar ( 60 ) and in so doing control the degree of extension of the spreading assembly in operation. The guide slot ( 62 ) can thus be sized to control the amount of extension possible for the spreading assembly ( 16 ). The distal most portion of the extending arm ( 56 ) can be provided with a base plate ( 64 ), which can be pivotally attached thereto. The base plate ( 64 ) is sized and configured to provide a contact surface ( 66 ) that in operation is brought into contact with the bone to be manipulated. This contact surface ( 66 ) can provide a protective element to distribute the pressure exerted by spreading assembly across a broader surface of the bone being manipulated. 
     To provide visual feedback to the surgeon, the device ( 10 ) can be manufactured such that at least a portion of the device is radiopaque. It is within the concept of the present teachings that only select portions of the device ( 10 ), such as, for example, the contact surface ( 66 ) or the base plate ( 64 ) are manufactured or treated to include radiopaque material. Any method known in the art to manufacture or treat the device ( 10 ) so as to have a radiopaque quality can be employed without departing from the general concept of the present teachings. 
     The first embodiment of the present teachings described above illustrates an aspect of the present teachings. It is, however, within the scope of the present teachings to configure the device ( 10 ) with a wide variety of handle assemblies ( 12 ) that would serve to actuate the device by movement of the actuating arm ( 46 ) with the actuating arm sleeve ( 44 ). Another non-limiting example of an alternative handle assembly ( 12 ) is shown in  FIG. 6 . This alternative handle assembly ( 12 ) can be configured similar to the scissor-like embodiment shown in  FIGS. 1-2  with the additional feature of a handle locking assembly, generally shown at ( 68 ). The handle locking assembly ( 68 ) can be provided with a locking catch ( 70 ) similar to that typically found on a hemostat instrument. The locking catch ( 70 ) can be employed with a handle locking arm ( 72 ) that is configured for releasably locking the handle assembly ( 12 ) to a desired open, partially open, or closed position as desired by the using surgeon. 
     Another embodiment of the present teachings can include an alternative handle assembly as shown in  FIG. 10 , which generally includes the basic features of the handle assemblies discusses above, that is, opposing first and second handle members ( 22 ,  23 ), a handle member connector ( 34 ) and pivot pin ( 36 ), an actuating arm anchor ( 42 ) for securing the distal end of the actuating arm ( 46 ), and at least one biasing member ( 38 ). The alternative handle assembly shown in  FIG. 10  also includes the additional feature of a grip stabilizing member ( 77 ), against which the users&#39; first thumb joint can rest during operation, and a controlled compression assembly, generally shown at ( 78 ), which provides a means for the user to fine-tune control the compression of the two handle members. The controlled compression assembly ( 78 ) includes a threaded compression shaft ( 79 ) that is rotatably connected to the second handle member ( 23 ) by a shaft securing member ( 80 ). The threaded compression shaft ( 79 ) slidably extends through a compression shaft bore ( 81 ) defined in the first handle member  22  and terminates in a manual controller stop ( 82 ). The manual controller stop ( 82 ) acts to limit the extreme movement of the manual controller ( 83 ), which is correspondingly-threaded and disposed around the threaded compression shaft ( 79 ). In one aspect of this handle assembly, the manual controller ( 83 ) is configured as a thumb wheel for ease of operation. In operation, the user can manually compress the handle members ( 22 ,  23 ) together and, if desired, move or thread the manual controller ( 83 ) along the threaded compression shaft ( 79 ) to a position that holds the two handle members ( 22 ,  23 ) in the selected position relative one to the other. Alternatively, the handle members can be moved toward or away from each other by simply manually turning the manual controller ( 83 ) so as to tighten or loosen the control member against the outward bias of the first handle member ( 22 ), the bias being provided by the at least one biasing member ( 38 ). 
     Without departing from the general concept of the present teachings, the handle assembly ( 12 ) can be provided as a simple grip and control mechanism, such as a knob, in place of a multi-membered squeeze-actuated handle. As best shown in  FIGS. 11A-11C , This alternative knob configuration can be provided as a simply configured control knob ( 88 ), which can be provided in any form as is known in the art, to include, for example a rotationally attached, longitudinally aligned knurled knob ( 88 ) employing a screw-type actuator ( 89 ) to advance or retract the actuating arm ( 46 ) within the sleeve ( 44 ); the knob being knurled ( 90 ) or equipped with one or more radially extending side grips ( 91 ), or equipped with a circumferentially disposed gripping ring ( 92 ), as is commonly used in the art, for example as a common handle for a water faucet valve. Regardless of the configuration selected, the knob ( 88 ) embodiment of the handle assembly provides for the user a gripping element with a manual device actuator to selectively expand or retract the spreading assembly ( 16 ) of the present teachings in much the same way as the other embodiments of the handle assembly ( 12 ). 
     Each of the alternative handle assembly embodiments discussed herein when manually operated by a user results in the movement of the actuating arm ( 46 ) within the sleeve ( 44 ) such that the spreading assembly ( 16 ) is expanded so as to manipulate tissue. 
     As best shown in  FIGS. 7A-B  and  8 A-B, additional alternative embodiments of the present teachings can be provided which employ the same concept of the earlier described embodiment with the modification of providing a dual-scissor assembly, generally shown at ( 74 ), that permits the use of two bracing members ( 58 ) pivotally attached to the actuating arm ( 46 ) at the proximal end and pivotally attached at a base plate pivot point ( 76 ). In  FIGS. 8A-B , an alternative embodiment using two bracing members ( 58 ) attached at a single base plate pivot point is shown in both the closed (A) and open (B) positions. In  FIGS. 7-A-B , the alternative embodiment is shown using two bracing members ( 58 ) attached at two distinct pivot points (alternative embodiments provide a configuration with the potential for increased leverage strength during the opening of the spreading assembly ( 16 ) as well as, in the case of  FIGS. 7A-B , a broader base of support for the base plate ( 64 ). 
     The present teachings provide a means of protecting the mechanism of the spreading assembly ( 16 ) from unwanted contact, entanglement, and interference with the tissue of a subject. On ingress, during operation, and on egress from the tissue-manipulation site within a subject, it is possible for surrounding tissue or bone to become so involved with the internal mechanism of the spreading assembly ( 16 ) that the device might be operationally impaired or rendered inoperable altogether. As shown in  FIG. 9 , the present teachings provide a protective sheath ( 84 ) constructed of a highly flexible, high memory material that tightly and closely overlays the entirety of the spreading assembly ( 16 ) so as to provide a protective layer capable of keeping all unwanted tissue contact from the working mechanism of the spreading assembly. 
     The sheath ( 84 ) can be constructed of any medically/surgically acceptable elastic formulation that can be easily stretched during full expansion of the spreading assembly ( 16 ) without losing its integrity and without causing extreme resistance to spreading and back pressure on the spreading assembly. Further, the material used to fabricate the sheath ( 84 ) will have extremely good memory, that is shape-recovery character, and as the spreading assembly is returned to its compact, non-spread configuration, the sheath will return to its tight, close relationship to the more compact configuration of the spreading assembly ( 16 ). Thus, the sheath ( 84 ), upon spreading of the spreading assembly ( 16 ), will provide protection of the mechanism and, upon return to the non-spread configuration the sheath ( 84 ) will provide a smooth tight surface around the spreading assembly so as to facilitate the easy passage of the spreading assembly from the subject when the user chooses to retract the device. The sheath ( 84 ) can be manufactured of a polyurethane material and will be circumferentially bonded to the sleeve ( 44 ) of the device at a bonding point ( 85 ) just before the spreading assembly ( 16 ) exit from the sleeve ( 44 ). In either embodiment, the sheath ( 84 ) bonded to the sleeve ( 44 ) or bonded to the actuating arm ( 46 ), the mechanism of bonding can be by any secure and permanent means known in the art to include, but not limited to using adhesives, heat sealing, shrink film adhesion, or mechanical connection, such as, for example a groove and circumferentially inserted securing ring ( 86 ). Alternatively, the sheath ( 84 ) can be bonded to the spreading assembly at a point just before the spreading mechanism of the spreading assembly ( 16 ). For those embodiments of the present teachings, where the spreading assembly can be released from the actuating arm and left within the subject as a structural support for the bone that that has been manipulated, the device can be configured to have a quick disconnect ( 87 ) point between the actuating arm ( 46 ) and the spreading assembly ( 16 ). Such a quick disconnect can be provided by mechanical disconnect means, manufacture of a programmed break-away or shear point for a given torque, or any method of providing such a disconnection as is known in the art. The sheath ( 84 ) for such an embodiment remains intact and in place around the spreading assembly ( 16 ). 
     The alternative configuration of the spreading assembly ( 16 ) shown in  FIG. 9  is similar in design and assembly to that earlier described in  FIGS. 7A and 7B  with the adjustment that the two extending arms ( 56 ) and the two bracing members ( 58 ) cross over each other respectively in a scissor-jack configuration. Each of the ends of the extending arms ( 56 ) and bracing members ( 58 ) terminate on two attachment points on the buft plate ( 64 ) in the same manner as the spreading assembly ( 16 ) embodiment shown in  FIGS. 7A and 7B . 
     Each of the embodiments described above are provided for illustrative purposes only and it is within the concept of the present teachings to include modifications and varying configurations without departing from the scope of the present teachings that is limited only by the claims included herewith.