US2017086890A1PendingUtilityA1

Lateral spinous process spacer

Assignee: GLOBUS MEDICAL INCPriority: Mar 26, 2007Filed: Dec 9, 2016Published: Mar 30, 2017
Est. expiryMar 26, 2027(~0.7 yrs left)· nominal 20-yr term from priority
A61B 2017/0256A61B 17/7062A61B 2090/3966A61B 2017/564A61B 17/7065A61F 2002/3008A61B 90/39A61F 2250/0098A61B 2090/3937
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Claims

Abstract

Interspinous process implants are disclosed. Also disclosed are systems and kits including such implants, methods of inserting such implants, and methods of alleviating pain or discomfort associated with the spinal column.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A method for stabilizing the vertebral column comprising:
 inserting a guidewire into a surgical site along a lateral surgical path, the guide wire extending from above a patient's skin to an interspinous space;   inserting a plurality of sequentially larger diameter tubes over the guide wire to dilate tissue and create a working surgical corridor;   inserting an implant over the guidewire and positioning the implant between adjacent spinous processes in the interspinous space, the implant comprising:
 a cannulated body comprising a support portion extending laterally along a lateral axis between first and second end portions, the body defining a cannula extending therethrough along the lateral axis; 
 wherein at least a portion of the first end portion extends beyond the support portion in a direction perpendicular to the lateral axis; 
 wherein the device is be inserted between the adjacent spinous processes of the vertebral column in a lateral direction along the lateral axis and is advanceable over the guidewire extending through the cannula; 
 wherein the first end portion is configured and dimensioned to engage and separate the adjacent spinous processes when inserted and to advance the device in the lateral direction to position the support portion in a predetermined position between the adjacent spinous processes; 
 wherein the first end portion comprises a generally wedge shape, and 
 wherein the implant is inserted and positioned between the adjacent spinous processes without removal of the supraspinous ligament. 
   
     
     
         2 . The method of  claim 1 , wherein at least a portion of the second end portion extends beyond the support portion in a direction perpendicular to the lateral axis. 
     
     
         3 . The method of  claim 1 , wherein the body is made from a polyetheretherketone (PEEK) material. 
     
     
         4 . The method of  claim 1 , wherein the first end portion comprises a generally frustoconical shape. 
     
     
         5 . The method of  claim 1 , wherein the wedge shape defines a first cone angle in the lateral direction and a second cone angle in a vertical direction that is perpendicular or transverse to the lateral axis; and
 wherein the first cone angle is greater than the second cone angle.   
     
     
         6 . The method of  claim 1 , wherein the support portion is configured and dimensioned to fit between adjacent spinous processes and further comprises:
 a proximal support surface spaced longitudinally from a distal support surface by a first distance, the support surfaces configured to contact adjacent spinous processes of the vertebral column, wherein the first distance is predetermined for spacing of two adjacent spinous processes when the device is implanted in the vertebral column.   
     
     
         7 . The method of  claim 1 , wherein the support portion has a generally circular cross-section. 
     
     
         8 . The method of  claim 1 , wherein the body is made from a titanium material. 
     
     
         9 . The method of  claim 2 , wherein a portion of the end portions are configured and dimensioned to contact the lateral sides of the spinous process when the device is implanted in the vertebral column. 
     
     
         10 . The method of  claim 1 , wherein the body is configured and dimensioned to be rotated in-situ to position the first and second end portions on opposite lateral sides of the spinous processes. 
     
     
         11 . The method of  claim 1 , wherein the body is maintained in an implanted position without additional fixation devices. 
     
     
         12 . A method for implantation in a treated area of an intervertebral space between vertebral bodies of a spine, comprising:
 inserting a guidewire into a surgical site along a lateral surgical path, the guide wire extending from above a patient's skin to an interspinous space;   inserting a plurality of sequentially larger diameter tubes over the guide wire to dilate tissue and create a working surgical corridor;   inserting an implant over the guidewire and positioning the implant between adjacent spinous processes in the interspinous space, the implant comprising:   positioning an implant in the interspinous space, the implant comprising:
 a spacer body comprising a central support portion extending along a lateral axis between first and second end portions, 
 the central support portion comprising a superior support surface and an inferior support surface, wherein the superior and inferior support surfaces each have a contact area capable of engaging with anatomy in the treated area and the superior and inferior surfaces are spaced apart a first distraction distance, 
 the first end portion comprising a generally wedge shape, the wedge shape having a superior end surface and an inferior end surface, the superior and inferior end surfaces each have a contact area capable of engaging with anatomy in the treated area and the first and second surfaces are spaced apart a second distraction distance, 
 wherein the first distraction distance is less than the second distraction distance, 
 wherein when the device is in a first implantation position the adjacent vertebral bodies are maintained substantially separated by at least the second distraction distance and when the device is in a second implantation position the adjacent vertebral bodies are maintained substantially separated by at least the first distraction distance, and 
 wherein the spacer body support portion is laterally advanceable from the first implantation position to the second implantation position and 
 wherein the implant is inserted and positioned between the adjacent spinous processes without removal of the supraspinous ligament. 
   
     
     
         13 . The method of  claim 12 , wherein the first end portion is tapered along its longitudinal length. 
     
     
         14 . The method of  claim 12 , wherein the body defines a cannula extending along the lateral axis through the body, the cannula configured and dimensioned for receiving the guidewire therethrough such that the device is advanceable over the guidewire. 
     
     
         15 . The method of  claim 12 , wherein in the second implantation position the first and second end portions are located laterally adjacent opposite lateral sides of a portion of the vertebral bodies. 
     
     
         16 . The method of  claim 12 , wherein the spacer body is maintained in the second implantation position without additional fixation devices. 
     
     
         17 . The method of  claim 12 , wherein the first end portion comprises an outer surface and, the first end portion further comprising a ramp portion along the outer surface. 
     
     
         18 . The method of  claim 12 , wherein the wedge shape further defining a first cone angle in a lateral direction along the lateral axis and a second cone angle in a vertical direction that is perpendicular or transverse to the lateral axis, wherein the first cone angle is greater than the second cone angle. 
     
     
         19 . The method of  claim 12 , wherein the body is made from PEEK (polyetheretherketone). 
     
     
         20 . The method of  claim 12 , wherein the body is made from titanium.

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