AU2009206394A1 - Dilator - Google Patents

Description

WO 2009/094463 PCT/US2009/031710 DILATOR CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority to and the benefit of and is a continuation-in-part of U.S. Provisional Patent Application Serial No. 61/062,448 entitled "Dilator" filed on January 23, 2008 which is incorporated herein by reference in its entirety. This application also claims priority to and is a continuation-in-part of U.S. Patent Application Serial No. 11/582,874 entitled "Minimally invasive tooling for delivery of interspinous spacer" filed on October 18, 2006 which is incorporated herein by reference in its entirety. BACKGROUND [0002] A variety of retractors and dilation systems have been used to provide a traditional "open" or "mini-open" approach to the posterior spine, as well as for providing the more modem "minimally invasive" and "percutaneous" access to the spine. The "open" or "mini-open" approaches to the spine typically require larger incisions. These larger incisions readily provide visual and instrument access to the surgical site; however, larger incisions generally result in greater damage to muscle tissue, blood loss, long healing times accompanied by prolonged pain and significant scaring. [0003] The development of minimally invasive, percutaneous procedures has provided a major improvement in reducing recovery time and post operative-pain. In minimally invasive, percutaneous techniques patient trauma is minimized by creating a relatively smaller incision, followed by the introduction of a series of successfully larger dilators installed in sequence to dilate the soft tissues and increase the effective size of the incision. In some cases, a guide wire is used to first access the surgical site and then cannulated dilators are installed over the wire. Following installation of the largest dilator deemed necessary, a cannula or retractor is advanced over the largest dilator for providing a working channel from the skin of the patient to the working space adjacent to the spine. Surgery is performed or an implant is inserted through a surgical port or cannula inserted into the dilated incision. 1 WO 2009/094463 PCT/US2009/031710 [0004] Instead of cutting a larger opening, sequential dilation splits the surrounding tissue to create a larger opening. Splitting the muscle fibers apart, rather than cutting the muscle causes less damage to the tissue and leads to faster recovery times and reduced patient discomfort. Also, sequential dilation provides an advantage in that it allows the surgeon to make an initially small incision, then gradually increase the size of the opening to the minimum size required for performing the surgical procedure, thus reducing tissue damage and speeding patient recovery time. [0005] Certain spinal procedures, such as those developed by VertiFlex, Inc. and described in U.S. Patent Application Serial No. 11/314,712 entitled "Systems and methods for posterior dynamic stabilization of the spine" filed on December 20, 2005 and U.S. Patent Application Serial No. 11/582,874 entitled "Minimally invasive tooling for delivery of interspinous spacer" filed on October 18, 2006 and U.S. Patent Application Serial No. 11/593,995 entitled "Systems and methods for posterior dynamic stabilization of the spine" filed on November 7, 2006, U.S. Patent Application Serial No. 12/148,104 entitled "Interspinous spacer" filed on April 16, 2008, U.S. Patent Application Serial No. 12/217,662 entitled "Interspinous spacer" filed on July 8, 2008, U.S. Patent Application Serial No. 12/220,427 entitled "Interspinous spacer" filed on July 24, 2008, U.S. Patent Application Serial No. 12/205,511 entitled "Interspinous spacer" filed on September 5, 2008, U.S. Patent Application Serial No. 12/338,793 entitled "Interspinous spacer" filed on December 18, 2008, U.S. Patent Application Serial No. 12/354,517 entitled "Interspinous spacer" filed on January 15, 2009, all of which are incorporated herein by reference in their entireties, access the surgical site through tissue and through the supraspinous ligament, for example, for the insertion of a device, such as an interspinous spacer. Whereas the procedure may be performed in an open, mini-open or minimally invasive, percutaneous approach, penetrating the supraspinous ligament can be challenging as the ligamentous tissue is not only strong but also slippery. However, penetrating the supraspinous ligament particularly lends itself well to sequential dilation as the ligament is formed of a cord of substantially uniformly oriented fibrous strands that are advantageously capable of being split apart rather than transversely cut for minimizing trauma and increasing patient recovery time. Furthermore, 2 WO 2009/094463 PCT/US2009/031710 approaching the interspinous process space through the supraspinous ligament, like the VertiFlex device, advantageously avoids the multifidus muscle and thereby preserves its critical function as a stabilizer of the lumbar spine. Because of the difficulties associated with penetrating ligament, there is a special need for a dilator and/or dilator system designed for accessing a surgical site through ligament such as the supraspinous or interspinous ligament. The current invention provides a dilator and dilator system for establishing an opening through ligament that may also be used in conjunction with minimally invasive, percutaneous procedures. SUMMARY [0006] According to one aspect of the invention, a dilator comprising a proximal portion and a distal portion interconnected by an elongated body portion is provided. At least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end. Two oppositely located channels are formed in the body portion and extend longitudinally into the distal portion. [0007] A system comprising a dilator and a cannula is provided. The dilator comprises a proximal portion and a distal portion interconnected by an elongated body portion. At least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end. Two oppositely located channels are formed in the body portion and extend longitudinally into the distal portion. The cannula includes two oppositely located channels on the outer surface and has a passageway configured to receive the dilator. [0008] A method is provided comprising the steps of inserting a dilator into a patient via a posterior midline approach between two adjacent spinous processes and distracting the adjacent spinous processes by advancing the dilator relative to the adjacent spinous processes. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. la is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. 3 WO 2009/094463 PCT/US2009/031710 [0010] FIG. lb is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0011] FIG. ic is a perspective view of a distal end of a dilator according to the present invention. [0012] FIG. Id is an end view of a distal end of a dilator according to the present invention. [0013] FIG. le is a cross-sectional view of the distal end of a dilator according to the present invention. [0014] FIG. 2a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0015] FIG. 2b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0016] FIG. 2c is a perspective view of a distal end of a dilator according to the present invention. [0017] FIG. 2d is an end view of a distal end of a dilator according to the present invention. [0018] FIG. 2e is a cross-sectional view of the distal end of a dilator according to the present invention. [0019] FIG. 3a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0020] FIG. 3b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0021] FIG. 3c is a perspective view of a distal end of a dilator according to the present invention. [0022] FIG. 3d is an end view of a distal end of a dilator according to the present invention. [0023] FIG. 3e is a cross-sectional view of the distal end of a dilator according to the present invention. [0024] FIG. 4a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. 4 WO 2009/094463 PCT/US2009/031710 [0025] FIG. 4b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0026] FIG. 4c is a perspective view of a distal end of a dilator according to the present invention. [0027] FIG. 4d is an end view of a distal end of a dilator according to the present invention. [0028] FIG. 4e is a cross-sectional view of the distal end of a dilator according to the present invention. [0029] FIG. 5a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0030] FIG. 5b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0031] FIG. 5c is a perspective view of a distal end of a dilator according to the present invention. [0032] FIG. 5d is an end view of a distal end of a dilator according to the present invention. [0033] FIG. 5e is a cross-sectional view of the distal end of a dilator according to the present invention. [0034] FIG. 6a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0035] FIG. 6b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0036] FIG. 6c is a perspective view of a distal end of a dilator according to the present invention. [0037] FIG. 6d is an end view of a distal end of a dilator according to the present invention. [0038] FIG. 7a is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. [0039] FIG. 7b is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention. 5 WO 2009/094463 PCT/US2009/031710 [0040] FIG. 7c is a perspective view of a distal end of a dilator according to the present invention. [0041] FIG. 7d is an end view of a distal end of a dilator according to the present invention. [0042] FIG. 8a is a side view of a cannula according to the present invention. [0043] FIG. 8b is a perspective view of a distal end of a cannula according to the present invention. DETAILED DESCRIPTION [0044] While the description of the dilator system of this invention will be discussed primarily in relation to spinal surgery, it should be understood that the system will find use in other areas of surgery in which a surgeon wishes to gain access to an internal cavity by cutting the skin and enlarging an incision in a body wall so that surgical instruments can be inserted to perform a desired surgical procedure. For example, the dilator system may be used to create an incision to provide access to the posterior spine through which pedicle screws may be percutaneously installed in one or more selected vertebra. Alternatively, the dilator system may be used to create an incision to access an invertebral disc space for performance of a minimally invasive discectomy procedure and/or spinal fusion procedure including the implantation of one or more intervertebral or interspinous process implants. [0045] Implants are inserted between adjacent spinous processes to distract the spine segments and maintain them in a position to relieve symptoms of spinal stenosis and other conditions that cause pain which is associated with the back. Such implants have a spacer which remains in place between the adjacent spinous processes. An opening is created in the supraspinous and/or interspinous ligament so that the implant can be inserted. The dilators of the present invention are used to step dilate or gradually dilate body tissue, in particular, the supraspinous and/or interspinous ligament. [0046] The dilator system of the present invention includes one or more dilators configured to work independently or in conjunction with one another. When used in conjunction with one another a first dilator is generally smaller in outer diameter or 6 WO 2009/094463 PCT/US2009/031710 cross-sectional area than that of a second dilator which typically is also cannulated so that the second dilator fits over the first dilator to dilate tissue. It should be noted that the second dilator, in one variation, is not cannulated but is sized larger than the first dilator. In such a variation, the first dilator is removed and the second dilator is inserted to expand body tissue. In another variation, the first dilator is cannulated to be placed over a guide wire that is first positioned in the patient. In any of the variations disclosed herein, the first dilator may also be cannulated. Although in some cases two dilators are discussed it should be noted that more than two dilators may be employed in any of the variations disclosed herein. Furthermore, some of the distal ends of the dilators of the present invention are sufficiently sharp or manufactured with integrated knife points to cut tissue without a need for a separate instrument such as a scalpel to create an initial incision in the skin or ligament which is then expanded with the dilators, whereas other dilators of the present invention have a distal end that is too blunt and a separate instrument such as a scalpel is employed to create the first incision in the tissue or ligament. [0047] With reference to FIG. la, there is shown a dilator 10 according to the present invention. The dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. ib, ic and le that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. In one variation, the channel 18 has a flat base between two sidewalls. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12. In the embodiment shown in FIGs. la-le, the distal end 16 portion has a cone shape shown in FIG. ic. An end view of the distal end 16 is 7 WO 2009/094463 PCT/US2009/031710 shown in FIG. Id illustrating the tip or point 24 of the cone or bore 24 in a cannulated version of the dilator. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. le, the cross-sectional area 26 of the distal end 16 is circular in shape. The cone-shaped dilator of FIGs. la-le is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The cone-shaped dilator 10 shown in FIG. 1 punctures ligament and passes through soft tissue easily and therefore, it can be used as a first dilator in a minimally invasive percutaneous procedure without the need to first create a cut with a separate sharp edge such as a scalpel. A sharper tip formed by a distal end 16 with a more acute angle 0 (see FIG. 1b) will prevent the tip 24 from slipping off to the sides of the ligament. [0048] Turning now to FIGs. 2a-2e, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 2a, the dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. 2b, 2c and 2e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between adjacent spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16. In the embodiment shown in FIGs. 2a-2e, the distal end 16 portion has a wedge shape formed by two substantially flat faces 28 that angle towards each other at the distal end 16 and form a line or rectangular tip 24 shown in FIG. 2d. An end view of the distal end 16 is shown in FIG. 2d illustrating 8 WO 2009/094463 PCT/US2009/031710 the line or rectangular tip 24 of the wedge. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 2e, the cross-sectional area 26 of the distal end 16 is rectangular in shape. The wedge-shaped dilator of FIGs. 2a-2e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that the length of the tip 24 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament. The wedge-shaped dilator 10 shown in FIGs. 2a-2e does not puncture ligament as readily as the dilator 10 of FIGs. la-le and hence, is typically used in conjunction with a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGs. 2a-2e which then splits the ligament to create a larger opening as it is inserted. For these reasons, the dilator of FIGs. 2a-2e is generally used as a first dilator in a mini-open or open procedure in which direct visual access is gained and a sharp edge is used to first create a cut. The line or rectangular shaped point 24 is centered as seen in FIGs. 2d and 2e and therefore advantageously assists in centering the location of the splitting on the ligament. It should be noted that a sharper tip may be formed by a distal end 16 with a more acute angle 0 (see FIG. 2b) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for truly percutaneous procedures. [0049] Turning now to FIGs. 3a-3e, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 3a, the dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. 3b, 3c, 3d and 3e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. When inserted in a patient and aligned with the 9 WO 2009/094463 PCT/US2009/031710 adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases towards the distal end 16. In the embodiment shown in FIGs. 3a-3e, the distal end 16 portion has a pyramid shape formed by four substantially flat faces 28 that angle towards each other at the distal end 16 and meet at a tip 24 shown in FIG. 3c and 3d. An end view of the distal end 16 is shown in FIG. 3d illustrating the tip 24 of the pyramid-shaped distal end 16. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 3e, the cross-sectional area 26 of the distal end 16 is substantially square in shape. The pyramid-shaped dilator of FIGs. 3a-3e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The pyramid-shaped dilator 10 shown in FIGs. 3a-3e can puncture ligament and pass through soft tissue and hence, is generally used as a first dilator in a minimally invasive percutaneous procedure without the need to first create a cut with a separate sharp edge such as a scalpel. A sharper tip formed by a distal end 16 with a more acute angle 0 (see FIG. 3b) will prevent the tip 24 from slipping off to the sides of the ligament. [0050] Turning now to FIGs. 4a-4e, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 4a, the dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. 4b, 4c, 4d and 4e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the 10 WO 2009/094463 PCT/US2009/031710 body 12 portion of the dilator 10. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16. In the embodiment shown in FIGs. 4a-4e, the distal end 16 portion has a pyramid shape formed by four substantially flat faces 28 that angle towards each other at the distal end 16 and form a tip 24 shown in FIG. 4d. An end view of the distal end 16 is shown in FIG. 4d illustrating the tip 24 of the pyramid. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 4e, the cross-sectional area 26 of the distal end 16 is a quadrilateral and, in the variation shown in FIG. 4e, the quadrilateral is a rhombus in which one of the diagonals 30 or the longest diagonal 30 is aligned with the channels 18 as opposed to the variation of FIGs. 3a-3e in which none of the diagonals are aligned with the channels 18. It is the intersection of two faces 28 that align with one channel 18 and the intersection of opposite two faces 28 that align with the other channel 18. In a variation in which no channels 18 are included, the difference between the dilator of FIGs. 3a-3e is in the shape of the quadrilateral. The pyramid-shaped dilator of FIGs. 4a-4e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that one of the diagonals or longest diagonal 30 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament such that the intersection of faces 28 form an edge along which ligament is split. The pyramid shaped dilator 10 shown in FIGs. 4a-4e in either the channeled or non-channeled 11 WO 2009/094463 PCT/US2009/031710 variations, splits ligament more readily than either of the channeled or non-channeled variations of the dilator 10 of FIGs. 3a-3e where the intersections of faces 28 are not aligned with the channels 18 or does not have a diagonal 30 that is longer relative to the other diagonal 30 which can be aligned with the fibrous ligament strands for easier splitting. The variation of FIGs. 4a-4e can be used with or without a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGs. 4a-4e which then splits the ligament to create a larger opening as it is inserted. The intersection of faces 28 or diagonal 30, when aligned substantially parallel to the ligament strands, assist in centering the location of the splitting on the ligament. It should be noted that a sharper tip, intersection or diagonal may be formed by a distal end 16 with a more acute angle 0 (see FIG. 4b) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for percutaneous procedures. [0051] Turning now to FIGs. 5a-5e, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 5a, the dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. 5b, 5c, 5d and 5e that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16. In the embodiment shown in FIGs. 5a-5e, the distal end 16 portion has two curved faces 28 that angle towards each other at the distal end 16 and 12 WO 2009/094463 PCT/US2009/031710 form a tip 24 shown in FIG. 5d. An end view of the distal end 16 is shown in FIG. 5d illustrating the tip 24. A cannulated variation of the dilator 10 is not shown but is within the scope of the present invention wherein the tip 24 would include an opening. In yet another variation, the tip 24 includes an opening to a blade housing through which a blade may extend. The blade (not shown) may also be retractable. When a cross-section of the distal end 16 is taken at a location distal to the channels 18 and perpendicular to the longitudinal axis of the dilator 10 as shown in FIG. 5e, the cross-sectional area 26 of the distal end 16 is comprised of an area bounded by two curved lines in which the length is aligned with the channels 18. It is the intersections of two faces 28 that align with one channel 18. In a variation in which no channels 18 are included, the length is aligned with the length of the ligament. The dilator 10 of FIGs. 5a-5e is generally employed as a first dilator 10 and may be cannulated for passing over a guide wire or if used as a subsequent dilator for passing over a previous dilator. The distal end 16 is positioned in the patient such that the length of the tip 24 is aligned along the cephalad-caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially parallel to the fibrous strands of the ligament or to the ligament itself such that the intersections of faces 28 form an edge along which ligament is split. The variation of FIGs. 5a-5e can be used with or without a scalpel or other sharp edge, for example, to create a small opening in the ligament prior to insertion of the dilator 10 of FIGs. 5a-5e which then splits the ligament to create a larger opening as it is inserted. The intersection of faces 28 when aligned substantially parallel to the ligament strands, assist in centering the location of the splitting on the ligament. It should be noted that a sharper tip, intersection or diagonal may be formed by a distal end 16 with a more acute angle 0 (see FIG. 5b) thereby, creating or a approaching a knife-like edge that can pierce the ligament without first using a sharp edge and therefore well suited for percutaneous procedures. [0052] Turning now to FIGs. 6a-6d, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 6a, the dilator 10 has an elongated body 12, a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 13 WO 2009/094463 PCT/US2009/031710 shown in FIGs. 6b, 6c and 6d that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous processes are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16. In the embodiment shown in FIGs. 6a-6d, the distal end 16 portion has a surface 28, that may also be curved that angles toward the distal end 16 and forms an opening 32 at tip 24 shown in FIGs. 6c and 6d. An end view of the distal end 16 is shown in FIG. 6d illustrating the opening 32 that forms distal end of the cannulation or bore 34 running along at least part of the length of the dilator 10. Because of the central bore 34 is sized to received therein a smaller dilator 10 such as any of the dilators described above in FIGs. 1-5, the dilator 10 of FIGs. 6a-6d is generally employed as a second dilator 10 or dilator 10 subsequent for passing over a previous dilator. The distal end 16 is positioned over a previous dilator 10 in the patient such that the channels 18 are aligned generally perpendicular to the cephalad caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially perpendicular to the fibrous strands of the ligament or to the ligament itself. When inserted, the cannula of FIGs. 6a-6d continues to distract the spinous processes as they ride in the channels 18 with the channels 18 helping with maintaining the proper orientation of the dilators 10 between the spinous processes. In one variation, the channels 18 are ramped or angled towards the distal end to improve upon the distraction action provided by the dilator. [0053] Turning now to FIGs. 7a-7d, there is shown another variation of a dilator 10 according to the present invention wherein like reference numbers are used to describe like parts. Referring first to FIG. 7a, the dilator 10 has an elongated body 12, 14 WO 2009/094463 PCT/US2009/031710 a proximal end 14 and a distal end 16. The dilator 10 includes a pair of channels 18 shown in FIGs. 7b, 7c and 7d that are oppositely located from each other and run parallel to the longitudinal axis of the dilator 10. The distal end 20 of the channel 18 commences in the distal end 16 and the proximal end 22 of the channel 18 ends in the body 12 portion of the dilator 10. In one variation, the channel 18 includes a flat base between two sidewalls. When inserted in a patient and aligned with the adjacent spinous processes, the channels 18 are advantageous for distracting the spinous processes apart as well as for keeping the dilator 10 in position between the spinous processes while being inserted especially in a "kissing" condition of the spine where the posterior tips of adjacent spinous process are in close proximity, touch or "kiss". In one variation, the channels 18 are absent from the dilator 10. The distal end 16 of the dilator 10 is a tapered portion where the diameter or cross-sectional area is less than the diameter or cross-sectional area of the body portion 12 and decreases toward the distal end 16. In the embodiment shown in FIGs. 7a-7d, the distal end 16 portion has a surface 28 that may also be curved that angles toward the distal end 16 and forms an opening 32 at tip 24 shown in FIGs. 7c and 7d. An end view of the distal end 16 is shown in FIG. 7d illustrating the opening 32 that forms distal end of the cannulation or bore 34 running along at least part of the length of the dilator 10. Because of the central bore 34 is sized to received therein a smaller dilator 10 such as any of the dilators described above in FIGs. 1-5, the dilator 10 of FIGs. 7a-7d is generally employed as a second dilator 10 or dilator 10 subsequent for passing over a previous dilator. The distal end 16 is positioned over a previous dilator 10 in the patient such that the channels 18 are aligned generally perpendicular to the cephalad caudal direction when puncturing the supraspinous ligament or otherwise aligned substantially perpendicular to the fibrous strands of the ligament or to the ligament itself. The dilator of FIGs. 7a-7d further includes a pair of oppositely located flats 36 that are aligned with the channels 18. At least part of the channel 18 is formed in the flats 36 and in one variation, the flat 36 is substantially parallel to the flat base of the channel 18. The flats 36 create a lower profile for the dilator 10 which is advantageous for insertion between closely spaced spinous processes. When inserted, the cannula of FIGs. 7a-7d continues to distract the spinous processes as they ride in 15 WO 2009/094463 PCT/US2009/031710 the channels 18 with the channels 18 helping with maintaining the proper orientation of the dilators 10 between the spinous processes. [0054] An entry point is selected on the patient's skin to obtain access to the targeted surgical site, and an incision of appropriate length is made through the dermal layers of a patient's body at the entry point. The length and depth of the incision may be larger depending on whether the clinician is using an open, mini-open, or minimally invasive, percutaneous approach. If a guide wire is used, the tip of the guide wire is then positioned within the incision and guided toward the spine using a cannnulated T-handled trocar. If a ligament such as the supraspinous or interspinous ligament is to be punctured with a sharp edge other than with the dilator, the sharp edge or scalpel is used to create a small cut in the ligament. One of the first dilators, such as any one of the dilators 10 described above in reference to FIGs. 1-5, is then inserted (over the guidewire if one is used) into the incision and into the cut in the ligament (if the ligament is pre-cut with a scalpel or other sharp edge). The first dilator is properly oriented (such that diagonal or edges are aligned with ligamentous strands as described above) and further inserted to spread apart body tissue and/or pierce and/or split and/or cut the ligament. After the first dilator is inserted a second dilator, such as any one of the dilators 10 described above in reference to FIGs. 6-7, is then passed over the proximal end 14 of the first dilator and further passed over the first dilator into the incision to further spread apart tissue and/or split the ligament. Any number of additional dilators, that are preferably cannulated for passing over the one or more previous dilators, are then inserted. A dilator with a channel 18 is oriented such that one of the adjacent spinous processes is positioned inside the channel 18 and in one variation, the other of the adjacent spinous processes is tracked inside the oppositely located channel 18. Such placement of the dilator with respect to the spinous processes stabilizes the dilator with respect to the spine. Advancement of the dilator relative to the adjacent spinous processes, ramps the adjacent spinous processes first at the tip of the distal portion and then inside the channel 18 if one is employed to distract the adjacent spinous processes. Subsequent dilators placed over the previous dilator may further distract the spinous processes. In one variation, the channels 18 themselves may be flat or further ramped to further distract the adjacent spinous 16 WO 2009/094463 PCT/US2009/031710 processes. After the desired amount of dilation with dilators is achieved, a cannula 40 of the type shown in FIGs. 8a-8b is passed over the last dilator 10 such that the dilators 10 are received in the cannula bore 42. The cannula 40 may further include oppositely located channels 44 for receiving the adjacent spinous processes, stabilizing the spinous processes with respect to the dilator and for further distraction of the adjacent spinous processes. The channels 44 are formed by four wings 46 extending outwardly from the surface. With the cannula 40 in place, the dilators 10 inside the cannula bore 42 are removed leaving an open cannula bore 42 through which surgery can be performed or an implant be inserted. [0055] All publications mentioned anywhere herein are incorporated herein by reference as part of the detailed description of the present invention to disclose and describe the methods and/or materials in connection with which the publications are cited or in connection with the present invention. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. [0056] The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. 17

Claims (26)

1. A dilator comprising: a proximal portion and a distal portion interconnected by an elongated body portion; at least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end; and two oppositely located channels formed in the body portion and extending longitudinally into the distal portion.

2. The dilator of claim 1 wherein at least part of the distal portion is substantially conical.

3. The dilator of claim 1 wherein the distal portion includes two flat faces angled towards each other in the distal direction; each of the two flat faces being oppositely located between the two channels.

4. The dilator of claim 3 wherein the two flat faces form a tip having a rectangular or line cross-section taken perpendicular to the longitudinal axis of the dilator.

5. The dilator of claim 3 wherein the two flat faces form an intersection at the distal end of the dilator; the intersection being aligned with the two channels.

6. The dilator of claim 5 wherein intersection is a sharp edge.

7. The dilator of claim 5 further including an opening along the intersection.

8. The dilator of claim 1 wherein at least part of the distal portion is substantially pyramidal. 18 WO 2009/094463 PCT/US2009/031710

9. The dilator of claim 1 wherein the distal portion includes four flat faces angled towards each other in the distal direction.

10. The dilator of claim 9 wherein the four flat faces have a rhomboidal cross-section taken perpendicual to the longitudinal axis of the dilator; the rhomboidal cross-section having a major diagonal aligned with each of the two channels.

11. The dilator of claim 1 wherein the body portion includes two oppositely located flat surfaces extending longitudinally along at least a portion of the body portion; at least part of each channel being formed in each of the two flat surfaces.

12. The dilator of claim 1 wherein each channel includes a flat base between two sidewalls.

13. The dilator of claim 12 wherein the body portion includes two flat surfaces formed on the body portion; one of the flat surfaces being substantially parallel to one of the flat base of one channel and the other of the flat surfaces being substantially parallel to the flat bases of the other channel.

14. The dilator of claim 1 wherein the dilator includes a passageway extending between an opening at the distal end and an opening at the proximal end.

15. The dilator of claim 1 further including a retractable blade at the distal end.

16. A system comprising: a dilator comprising: a proximal portion and a distal portion interconnected by an elongated body portion; at least a part of the distal portion has a cross-sectional area decreasing with distance towards the distal end; and 19 WO 2009/094463 PCT/US2009/031710 two oppositely located channels formed in the body portion and extending longitudinally into the distal portion; and a cannula including two oppositely located channels on the outer surface and having a passageway configured to receive the dilator.

17. The system of claim 16 wherein the cannula is configured to receive the dilator inside the passageway such that the channels of the cannula are aligned with the channels of the dilator.

18. A method comprising the steps of: inserting a dilator into a patient via a posterior midline approach between two adjacent spinous processes; and distracting the adjacent spinous processes by advancing the dilator relative to the adjacent spinous processes.

19. The method of claim 18 further including the step of positioning one of the adjacent spinous processes inside one longitudinal channel formed on the dilator.

20. The method of claim 19 further including the step of moving the spinous process inside the longitudinal channel relative to the dilator.

21. The method of claim 19 further including the step of positioning the other of the adjacent spinous processes inside another longitudinal channel formed on the dilator.

22. The method of claim 18 further including the steps of: placing a cannula over the dilator; and aligning at least one channel formed on the cannula with at least one channel formed on the dilator.

23. The method of claim 22 further including the step of distracting the adjacent spinous processes with advancement of the cannula over the dilator. 20 WO 2009/094463 PCT/US2009/031710

24. The method of claim 1 further including the step of inserting the dilator through the supraspinous ligament.

25. The method of claim 1 further including the step of stabilizing the dilator with respect to one of the adjacent spinous processes with a first channel formed in the outer surface of the dilator; and stabilizing the dilator with respect to the other of the adjacent spinous processes with a second channel formed in the outer surface of the dilator.

26. The method of claim 1 further including the step of splitting ligamentous tissue with the dilator. 21