WO2009094463A2 - Dilatateur - Google Patents

Dilatateur Download PDF

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Publication number
WO2009094463A2
WO2009094463A2 PCT/US2009/031710 US2009031710W WO2009094463A2 WO 2009094463 A2 WO2009094463 A2 WO 2009094463A2 US 2009031710 W US2009031710 W US 2009031710W WO 2009094463 A2 WO2009094463 A2 WO 2009094463A2
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WO
WIPO (PCT)
Prior art keywords
dilator
distal end
spinous processes
channels
adjacent spinous
Prior art date
Application number
PCT/US2009/031710
Other languages
English (en)
Other versions
WO2009094463A3 (fr
Inventor
Shawn Tebbe
Moti Altarac
Yang Cheng
Original Assignee
Vertiflex, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vertiflex, Inc. filed Critical Vertiflex, Inc.
Priority to EP09703374A priority Critical patent/EP2244781A2/fr
Priority to AU2009206394A priority patent/AU2009206394A1/en
Priority to CA2712011A priority patent/CA2712011A1/fr
Publication of WO2009094463A2 publication Critical patent/WO2009094463A2/fr
Publication of WO2009094463A3 publication Critical patent/WO2009094463A3/fr
Priority to IL206929A priority patent/IL206929A0/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/32093—Incision instruments for skin incisions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00261—Discectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0256—Joint distractors for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320056—Tunnelers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/346—Details of tips with wings

Definitions

  • 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 modern “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 scarring.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Two oppositely located channels are formed in the body portion and extend longitudinally into the distal portion.
  • a system comprising a dilator and a cannula
  • 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.
  • 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.
  • FIG. Ia is a side view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention.
  • FIG. Ib is a top view of a dilator and an enlarged portion of the distal end of the dilator according to the present invention.
  • FIG. Ic is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. Id is an end view of a distal end of a dilator according to the present invention.
  • FIG. Ie is a cross-sectional view of the distal end of a dilator according to the present invention.
  • 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.
  • 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.
  • FIG. 2c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 2d is an end view of a distal end of a dilator according to the present invention.
  • FIG. 2e is a cross-sectional view of the distal end of a dilator according to the present invention. [0019] FIG.
  • 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.
  • 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.
  • FIG. 3c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 3d is an end view of a distal end of a dilator according to the present invention.
  • FIG. 3e is a cross-sectional view of the distal end of a dilator according to the present invention.
  • 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.
  • 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.
  • FIG. 4c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 4d is an end view of a distal end of a dilator according to the present invention.
  • FIG. 4e is a cross-sectional view of the distal end of a dilator according to the present invention.
  • 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.
  • 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.
  • FIG. 5c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 5d is an end view of a distal end of a dilator according to the present invention.
  • FIG. 5e is a cross-sectional view of the distal end of a dilator according to the present invention.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 6c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 6d is an end view of a distal end of a dilator according to the present invention.
  • 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.
  • 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.
  • FIG. 7c is a perspective view of a distal end of a dilator according to the present invention.
  • FIG. 7d is an end view of a distal end of a dilator according to the present invention.
  • FIG. 8a is a side view of a cannula according to the present invention.
  • FIG. 8b is a perspective view of a distal end of a cannula according to the present invention.
  • the dilator system of this invention 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.
  • 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.
  • the dilator system may be used to create an incision to access an in vertebral 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.
  • 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.
  • the dilator system of the present invention includes one or more dilators configured to work independently or in conjunction with one another.
  • a first dilator is generally smaller in outer diameter or 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.
  • 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.
  • the first dilator is cannulated to be placed over a guide wire that is first positioned in the patient.
  • 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.
  • 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.
  • 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 Ie 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.
  • the channel 18 has a flat base between two sidewalls.
  • 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".
  • 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. Ia-Ie, the distal end 16 portion has a cone shape shown in FIG. Ic.
  • FIG. Id An end view of the distal end 16 is shown in FIG. Id illustrating the tip or point 24 of the cone or bore 24 in a cannulated version of the dilator.
  • FIG. Ie An end view of the distal end 16 is shown in FIG. Id illustrating the tip or point 24 of the cone or bore 24 in a cannulated version of the dilator.
  • the cross-sectional area 26 of the distal end 16 is circular in shape.
  • the cone-shaped dilator of FIGs. Ia-Ie 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.
  • 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 ⁇ will prevent the tip 24 from slipping off to the sides of the ligament.
  • 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.
  • 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.
  • 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".
  • 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.
  • 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 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.
  • 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. Ia-Ie 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.
  • 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.
  • a sharper tip may be formed by a distal end 16 with a more acute angle ⁇ (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.
  • 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.
  • 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".
  • 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.
  • 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.
  • 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 ⁇ will prevent the tip 24 from slipping off to the sides of the ligament.
  • 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 body 12 portion of the dilator 10.
  • 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".
  • 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.
  • 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.
  • 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.
  • the difference between the dilator of FIGs. 3a-3e is in the shape of the quadrilateral.
  • first dilator 10 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.
  • FIGs. 4a-4e in either the channeled or non-channeled 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.
  • 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.
  • 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.
  • 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".
  • 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.
  • the distal end 16 portion has two curved faces 28 that angle towards each other at the distal end 16 and 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.
  • the tip 24 includes an opening to a blade housing through which a blade may extend.
  • the blade (not shown) may also be retractable.
  • 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.
  • the length is aligned with the length of the ligament.
  • 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.
  • FIG. 5a-5e which then splits the ligament to create a larger opening as it is inserted.
  • a sharper tip, intersection or diagonal may be formed by a distal end 16 with a more acute angle ⁇ (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.
  • 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.
  • 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. 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.
  • 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".
  • 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.
  • 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.
  • 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.
  • the channels 18 are ramped or angled towards the distal end to improve upon the distraction action provided by the dilator. Turning now to FIGs.
  • 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. 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.
  • the channel 18 includes a flat base between two sidewalls.
  • 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".
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the channels 18 themselves may be flat or further ramped to further distract the adjacent spinous processes.
  • 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.

Abstract

L'invention porte sur un dilatateur qui facilite une implantation d'un espaceur interépineux. Le dilatateur comprend une partie proximale et une partie distale effilée reliées entre elles par une partie corps allongée. La partie distale effilée est idéalement adaptée pour la séparation d'un tissu ligamentaire afin de créer un trajet de ligne médiane postérieur à travers le ligament sus-épineux ainsi que pour la distraction des apophyses épineuses adjacentes. Deux canaux ou rainures situés de manière opposée et s'étendant longitudinalement sont formés dans la surface externe du dilatateur pour stabiliser le dilatateur par rapport aux apophyses épineuses. Une canule accompagnante conjointement avec le dilatateur forment un système pour la distraction des apophyses épineuses adjacentes, la stabilisation des apophyses épineuses par rapport au système et la création d'un canal de travail pour l'implantation d'un espaceur interépineux.
PCT/US2009/031710 2008-01-23 2009-01-22 Dilatateur WO2009094463A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP09703374A EP2244781A2 (fr) 2008-01-23 2009-01-22 Dilatateur
AU2009206394A AU2009206394A1 (en) 2008-01-23 2009-01-22 Dilator
CA2712011A CA2712011A1 (fr) 2008-01-23 2009-01-22 Dilatateur
IL206929A IL206929A0 (en) 2008-01-23 2010-07-11 Dilator

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6244808P 2008-01-23 2008-01-23
US61/062,448 2008-01-23

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WO2009094463A2 true WO2009094463A2 (fr) 2009-07-30
WO2009094463A3 WO2009094463A3 (fr) 2009-10-22

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EP (1) EP2244781A2 (fr)
AU (1) AU2009206394A1 (fr)
CA (1) CA2712011A1 (fr)
IL (1) IL206929A0 (fr)
WO (1) WO2009094463A2 (fr)

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WO2012038756A1 (fr) * 2010-09-24 2012-03-29 Surgical Innovations Limited Pointe de trocart
US9125692B2 (en) 2004-10-20 2015-09-08 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9155570B2 (en) 2004-10-20 2015-10-13 Vertiflex, Inc. Interspinous spacer
US9155572B2 (en) 2004-10-20 2015-10-13 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
US9161783B2 (en) 2004-10-20 2015-10-20 Vertiflex, Inc. Interspinous spacer
US9186186B2 (en) 2009-12-15 2015-11-17 Vertiflex, Inc. Spinal spacer for cervical and other vertebra, and associated systems and methods
US9211146B2 (en) 2004-10-20 2015-12-15 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9283005B2 (en) 2004-10-20 2016-03-15 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US9314279B2 (en) 2004-10-20 2016-04-19 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9393055B2 (en) 2004-10-20 2016-07-19 Vertiflex, Inc. Spacer insertion instrument
US9445843B2 (en) 2004-10-20 2016-09-20 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9532812B2 (en) 2004-10-20 2017-01-03 Vertiflex, Inc. Interspinous spacer
US9566086B2 (en) 2006-10-18 2017-02-14 VeriFlex, Inc. Dilator
US9572603B2 (en) 2004-10-20 2017-02-21 Vertiflex, Inc. Interspinous spacer
US9675303B2 (en) 2013-03-15 2017-06-13 Vertiflex, Inc. Visualization systems, instruments and methods of using the same in spinal decompression procedures
US9861398B2 (en) 2004-10-20 2018-01-09 Vertiflex, Inc. Interspinous spacer
US9877749B2 (en) 2004-10-20 2018-01-30 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10278744B2 (en) 2004-10-20 2019-05-07 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10292738B2 (en) 2004-10-20 2019-05-21 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for stabilizing the motion or adjusting the position of the spine
US10524772B2 (en) 2014-05-07 2020-01-07 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
EP4162969A3 (fr) * 2021-09-16 2023-07-05 Covidien LP Dilatateurs chirurgicaux et ensembles et procédés associés

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US10039576B2 (en) 2004-10-20 2018-08-07 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9572603B2 (en) 2004-10-20 2017-02-21 Vertiflex, Inc. Interspinous spacer
US9155570B2 (en) 2004-10-20 2015-10-13 Vertiflex, Inc. Interspinous spacer
US10058358B2 (en) 2004-10-20 2018-08-28 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9161783B2 (en) 2004-10-20 2015-10-20 Vertiflex, Inc. Interspinous spacer
US11076893B2 (en) 2004-10-20 2021-08-03 Vertiflex, Inc. Methods for treating a patient's spine
US9211146B2 (en) 2004-10-20 2015-12-15 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9283005B2 (en) 2004-10-20 2016-03-15 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US9314279B2 (en) 2004-10-20 2016-04-19 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9393055B2 (en) 2004-10-20 2016-07-19 Vertiflex, Inc. Spacer insertion instrument
US9445843B2 (en) 2004-10-20 2016-09-20 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9532812B2 (en) 2004-10-20 2017-01-03 Vertiflex, Inc. Interspinous spacer
US10835297B2 (en) 2004-10-20 2020-11-17 Vertiflex, Inc. Interspinous spacer
US10610267B2 (en) 2004-10-20 2020-04-07 Vertiflex, Inc. Spacer insertion instrument
US10835295B2 (en) 2004-10-20 2020-11-17 Vertiflex, Inc. Interspinous spacer
US9861398B2 (en) 2004-10-20 2018-01-09 Vertiflex, Inc. Interspinous spacer
US9877749B2 (en) 2004-10-20 2018-01-30 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US9956011B2 (en) 2004-10-20 2018-05-01 Vertiflex, Inc. Interspinous spacer
US9155572B2 (en) 2004-10-20 2015-10-13 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
US10709481B2 (en) 2004-10-20 2020-07-14 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10166047B2 (en) 2004-10-20 2019-01-01 Vertiflex, Inc. Interspinous spacer
US10080587B2 (en) 2004-10-20 2018-09-25 Vertiflex, Inc. Methods for treating a patient's spine
US10258389B2 (en) 2004-10-20 2019-04-16 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10278744B2 (en) 2004-10-20 2019-05-07 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10292738B2 (en) 2004-10-20 2019-05-21 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for stabilizing the motion or adjusting the position of the spine
US9125692B2 (en) 2004-10-20 2015-09-08 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US10653456B2 (en) 2005-02-04 2020-05-19 Vertiflex, Inc. Interspinous spacer
US10588663B2 (en) 2006-10-18 2020-03-17 Vertiflex, Inc. Dilator
US9566086B2 (en) 2006-10-18 2017-02-14 VeriFlex, Inc. Dilator
US11013539B2 (en) 2006-10-18 2021-05-25 Vertiflex, Inc. Methods for treating a patient's spine
US11229461B2 (en) 2006-10-18 2022-01-25 Vertiflex, Inc. Interspinous spacer
US9186186B2 (en) 2009-12-15 2015-11-17 Vertiflex, Inc. Spinal spacer for cervical and other vertebra, and associated systems and methods
WO2012038756A1 (fr) * 2010-09-24 2012-03-29 Surgical Innovations Limited Pointe de trocart
US9675303B2 (en) 2013-03-15 2017-06-13 Vertiflex, Inc. Visualization systems, instruments and methods of using the same in spinal decompression procedures
US10524772B2 (en) 2014-05-07 2020-01-07 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
US11357489B2 (en) 2014-05-07 2022-06-14 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
EP4162969A3 (fr) * 2021-09-16 2023-07-05 Covidien LP Dilatateurs chirurgicaux et ensembles et procédés associés

Also Published As

Publication number Publication date
EP2244781A2 (fr) 2010-11-03
WO2009094463A3 (fr) 2009-10-22
CA2712011A1 (fr) 2009-07-30
AU2009206394A1 (en) 2009-07-30
IL206929A0 (en) 2010-12-30

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