EP2262434A2 - Système à instrument écarteur d apophyse épineuse à indicateur de déploiement - Google Patents

Système à instrument écarteur d apophyse épineuse à indicateur de déploiement

Info

Publication number
EP2262434A2
EP2262434A2 EP09718826A EP09718826A EP2262434A2 EP 2262434 A2 EP2262434 A2 EP 2262434A2 EP 09718826 A EP09718826 A EP 09718826A EP 09718826 A EP09718826 A EP 09718826A EP 2262434 A2 EP2262434 A2 EP 2262434A2
Authority
EP
European Patent Office
Prior art keywords
spacer
deployment
instrument
instrument system
indicator
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP09718826A
Other languages
German (de)
English (en)
Inventor
Shawn Tebbe
Moti Altarac
Daniel H. Kim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
VertiFlex Inc
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
Publication of EP2262434A2 publication Critical patent/EP2262434A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor

Definitions

  • spinal stenosis With spinal stenosis, the spinal canal narrows and pinches the spinal cord and nerves, causing pain in the back and legs.
  • a person's ligaments may thicken, intervertebral discs may deteriorate and facet joints may break down — all contributing to the condition of the spine characterized by a narrowing of the spinal canal.
  • Injury, heredity, arthritis, changes in blood flow and other causes may also contribute to spinal stenosis.
  • a spacer is implanted between adjacent spinous processes of a patient's spine.
  • the implanted spacer opens the spinal canal, neural foramen, maintains the desired distance between vertebral body segments, and as a result, reduces the impingement of nerves and relieves pain.
  • an implantable interspinous spacer may provide significant benefits in terms of pain relief.
  • any surgery is an ordeal.
  • the type of device and how it is implanted has an impact.
  • one consideration when performing surgery to implant an interspinous spacer is the size of the incision that is required to allow introduction of the device. Small incisions and minimally invasive techniques are generally preferred as they affect less tissue and result in speedier recovery times.
  • interspinous spacers and instruments that are used to implant them that work well with surgical techniques that are percutaneous and/or minimally invasive for the patient that can also be used in an open or mini-open procedure.
  • the present invention sets forth such an instrument system.
  • an instrument system is provided.
  • the system includes an interspinous process spacer, an inserter, a driver and a deployment indicator.
  • the inserter is configured to releasably attach to the spacer at one end for implanting the spacer into a patient's interspinous process space.
  • the driver that is connected to the inserter is configured to arrange the spacer from at least one undeployed configuration to at least one deployed configuration and the deployment indicator provides at least one information to the user pertaining to the degree of deployment of the attached spacer.
  • an instrument for inserting a deployable interspinous process spacer into a patient includes a first end connectable to an interspinous process spacer and a second end configured to arrange a connected spacer between at least a first configuration and at least a second configuration.
  • the instrument includes a sensor configured to measrue the arrangement of a connected spacer and provide a signal regarding the arrangement of a connected spacer to the user.
  • FIG. IA illustrates a side view of a spacer instrument system connected to a spacer in a closed or an undeployed configuration according to the present invention.
  • FIG. IB illustrates a side view of a spacer instrument system connected to a spacer in an open or deployed configuration according to the present invention.
  • FIG. 2 illustrates a perspective partial end view of an inserter and driver of a spacer instrument system according to the present invention.
  • FIG. 3A illustrates a perspective view of a driver according to the present invention.
  • FIG. 3B illustrates a side view of a driver according to the present invention.
  • FIG. 3C illustrates a cross-sectional view taken along line A-A of FIG. 3B of the driver according to the present invention.
  • FIG. 3D illustrates a side view of a driver according to the present invention.
  • FIG. 4A illustrates a perspective view of a spacer in an undeployed or closed configuration according to the present invention.
  • FIG. 4B illustrates a perspective view of a spacer in a deployed or open configuration according to the present invention.
  • FIG. 4C illustrates a top view of a spacer in a deployed or open configuration according to the present invention.
  • FIGs. IA and IB there is shown a spacer instrument system
  • the spacer instrument system 10 includes an inserter 14 and a driver 16.
  • the inserter 14 is of the type described in co- pending U.S. Patent Application Serial No. 12/338,793 entitled “Spacer insertion instrument” filed on December 18, 2008 which claims the benefit of U.S. Provisional Patent Application Serial No. 61/008,418 entitled “Spacer insertion instrument” filed on December 19, 2007 both of which are assigned to VertiFlex, Inc. and hereby incorporated by reference in their entireties.
  • the inserter 14 is configured to releasably clamp to a body of an interspinous process implant or spacer 12 to be delivered into or removed from a patient using the system 10.
  • the inserter 14 includes an inner shaft 18, an outer shaft 20, a control 22 and handle assembly 24.
  • the inner shaft 18 is connected to the handle assembly 24 of the inserter 14 and the outer shaft 20 is passed over the inner shaft 18 and allowed to translate with respect to the inner shaft 18 by means of a control 22 that is threadingly engaged with the outer shaft 20.
  • a control 22 that is threadingly engaged with the outer shaft 20.
  • the outer shaft 20 is connected to handle assembly 24 and the inner shaft is threadingly connected to the control 22 such that rotation of the control 22 moves the inner shaft 18 with respect to the outer shaft 20 proximally or distally.
  • rotation of the control 22 is used in one variation, other variations are within the scope of the present invention such as, for example, translation of the control 22 or movement of the outer shaft 20 relative to the inner shaft 18.
  • the inner shaft 18 of the inserter 14 is substantially cylindrical in shape having a central bore extending from end to end.
  • the distal end of the inner shaft 18 includes a pair of prongs 26 with each prong being substantially oppositely located from each other.
  • the finger-like prongs 26 are flexible and, when in a normal position, splay slightly outwardly from the longitudinal axis.
  • the prongs 26 are configured to connect with the spacer 12.
  • the prongs 26 include extensions 28 that extend inwardly toward the longitudinal axis in a hook-like fashion. These extensions 28 are configured to be inserted into prong-receiving portions 30 (see FIGs. 4A, 4B and 4C) on the spacer 12 and securely clamp thereto.
  • the prongs 26 also include conforming surfaces configured to conform to the spacer 12 in a manner best suited for secure attachment thereto.
  • the proximal end of the inner shaft 18 is configured for insertion into and connection with a conformingly shaped recess in the handle 24.
  • the outer shaft 20 of the inserter 14 will now be described.
  • the outer shaft 22 is substantially cylindrical in shape having a central bore 32 extending from end to end.
  • the outer shaft 20 is sized such that the inner shaft 18 fits inside the outer shaft 20.
  • the distal end includes a pair of flattened portions 34 located substantially opposite from each other for a narrower profile and in one variation a ramped profile for insertion or placement between adjacent spinous processes of a patient's spine.
  • the ramped profile serves to distract the adjacent spinous processes apart slightly as the inserter is being inserted between the adjacent spinous processes for insertion of the connected spacer 12 wherein the flattened portions 34 are separated by an increasingly wider distance towards the proximal end of the instrument.
  • the outer shaft 20 includes a threaded proximal portion (not shown). The threaded proximal portion is configured for threaded connection with the control 22 such that movement of the control 22 moves the outer shaft 20.
  • the control 22 includes a user interface such as a finger portion or grip.
  • the user interface is an outer circular or disk- shaped portion for easily effecting rotation of the control 22 with a thumb or index finger.
  • the control 22 is configured to effect relative translation of the inner shaft 18 with respect to the outer shaft 20.
  • the spacer instrument system 10 functions to engage with, insert and deploy an interspinous spacer 12 in an interspinous process space between two adjacent vertebrae. Illustrative examples of interspinous spacers that are compatible with the insertion instrument are described in applicant's co-pending U.S. Patent Application Serial No. 12/148,104 entitled “Interspinous spacer” filed on April 16, 2008 which claims the benefit of U.S. Provisional Patent Application Serial No.
  • FIGs. 4A, 4B and 4C An example of an interspinous spacer 12 is shown in FIGs. 4A, 4B and 4C.
  • each spacer 12 includes a body portion 36 with at least one prong receiving portion 30 for connecting with the instrument 10, at least one wing 40 rotatably connected to the body 36 and an actuator shaft 38 housed in the body portion 36 and configured to arrange the at least one wing 40 from at least one undeployed configuration (see FIG. 4A) to at least one deployed configuration (see FIGs. 4B and 4C) and vice versa.
  • the wings 40 are configured to laterally stabilize the body portion 36 relative to thespinous processes, seat and/or space apart the spinous processes of adjacent vertebrae when in the deployed configuration to relieve pain.
  • the spacer instrument system 10 utilizes the working channel that is preferably created by the use of one or more tools such as a target needle, K- wire, dilators, mounting bracket, cannula, stabilizing arm, interspinous knife, interspinous reamer, and interspinous gage, all described in applicant's co-pending U.S. Patent Application Serial No. 11/582,874 entitled "Minimally invasive tooling for delivery of interspinous spacer" filed on October 18, 2006, incorporated herein by reference in its entirety.
  • the inserter 14 is typically inserted through a cannula with the distal end positioned at the interspinous process space in a minimally invasive, percutaneous, mini-open or open surgical procedure. In some procedures, a cannula is not employed to deliver the spacer instrument system 10 and spacer 12 to the interspinous space.
  • a spacer 12 is placed in juxtaposition to the distal end of the inserter 14 such that the prongs 26 of the inserter 14 are adjacent to the prong receiving portions 30 on the spacer 12.
  • the control 22 is then activated to clamp the prongs 26 of the inner shaft 18 onto the spacer 12.
  • the control 22 is rotated in one direction which advances the outer shaft 20 over the inner shaft 18 to thereby inwardly deflect the outwardly splayed prongs 26 at the distal end of the inner shaft 18.
  • This inward deflection allows the prongs 26 to engage the spacer body 36 and, in particular, allows the prong extensions 28 to be inserted into the prong receiving portions 30 and with further rotation of the control 22 to lock the inserter 14 securely onto the spacer 12.
  • Reverse rotation of the control 22 translates the outer shaft 20 proximally to expose the prongs 26 allowing them to splay outwardly to their pre- stressed normal position and thereby release the spacer 12 from the inserter 14.
  • the inserter 14 with the attached spacer 12 is sized to fit through a cannula and is passed through the cannula to the interspinous process space.
  • the driver 16 is inserted into the proximal opening of the central passageway of the inserter 14 and passed until the driver 16 connects with the spacer 12.
  • the driver 16 includes: (1) a handle 42 having a proximal end 44 and a distal end 46, (2) a inner shaft 48, (3) outer shaft 50, (3) a spacer engaging bit 54 connected to the distal end of the outer shaft 50, and (4) a spring 52.
  • the outer shaft 50 which is connected to the distal end 46 of the handle 42 includes a lumen in which the inner shaft 48 is disposed.
  • the inner shaft 48 includes a collar 56 (shown in FIG. 3C) configured to be located inside the handle 42 and biased against the spring 52 and configured such that the spring 52 forces the inner shaft 48 distally in a direction towards the spacer engaging bit 54.
  • the proximal end 44 of the handle 42 includes a deployment indicator window 58 through which the inner shaft 48 is viewed.
  • FIG. 2 illustrates the distal end of the driver 16 inserted into the inserter 14.
  • the connection of the driver 16 with the spacer 12, in particular the spacer engaging bit 54 will be different.
  • the driver 16 connects to the spacer 12 such that movement, such as rotation, of the driver 16 effects deployment of a deployable spacer 12, in particular, the deployment of the at least one wing 40 of the spacer 12.
  • movement of the driver 16 effects deployment of a deployable spacer 12, in particular, the deployment of the at least one wing 40 of the spacer 12.
  • rotation of the driver 16 that is connected to the spacer 12 effects translation of the actuator shaft 38 of the spacer 12 which in turn is connected to the at least one wing 40 causing it to deploy into an expanded configuration or deployed configuration.
  • the driver 16 that is configured to connect with the spacer 12 of FIGs. 4A-4C will have a spacer engaging bit 54 that includes two projecting features 60.
  • the two projecting features 60 engage complementary features 62 on the spacer 12 located inside the spacer body portion 36 as shown in FIGs. 4A-4C.
  • rotation of the driver 16 rotates the spindle 64 which in turn advances the actuator shaft 38 to deploy the wings 70 into the configuration shown in FIGs. 4B and 4C.
  • Reverse rotation of the driver 16 will turn the spindle 64 in an opposite direction and proximally translate the actuator shaft 38 to undeploy the wings 40. As can be seen in FIGs.
  • the actuator shaft 38 when in the deployed configuration, the actuator shaft 38 is distally translated with rotation of the driver 16 relative to when in the undeployed configuration as shown in FIG. 4A wherein the actuator shaft 38 projects proximally from the spacer body 36. This distance traveled by the actuator shaft 38 provides the information about the degree of deployment of the wings 40 of the spacer 12 that is communicated to the inner shaft 48 of the driver 16.
  • the inner shaft 48 of the driver 16 contacts the proximal end 66 of the actuator shaft 38 and will bias the inner shaft 48 a distance related to the distance with which the actuator shaft 38 projects proximally from the spacer body 36.
  • the bias force of the spring 52 will keep the distal end of the inner shaft 48 of the driver 16 in contact with the proximal end 66 of the actuator shaft 38 as it translates proximally or distally providing an indication as to the degree of deployment of the spacer 12.
  • the indication as to the degree of deployment of the spacer 12 is viewed at the proximal end of the system 10. Because the handle 24 resides outside the patient, the deployment information is readily visible to the surgeon.
  • FIG. IA there is shown the system 10 in an undeployed configuration.
  • the inner shaft 48 projects outwardly from the proximal end 44 of the handle 24.
  • the driver 16 is rotated to deploy the spacer 12
  • the inner shaft 48 moves distally until the inner shaft 48 does not project outwardly from the proximal end 44 of the handle 24 and/or is co-planar with the proximal end 44 of the handle 24 as shown in FIG.
  • the degree of deployment is related to the distance with which the inner shaft 48 is projecting outwardly from the proximal end 44 of the handle 24.
  • the proximal end of the inner shaft 48 or "button" provides the surgeon not only with visual feedback but also tactile feedback as to the degree of deployment.
  • FIG. IA Another deployment indicator is provided alternatively or in conjunction with the projection of the inner shaft 48 from the proximal end 44 just described.
  • This other deployment indicator includes an indicator line 68 (shown in FIGs. IB and 3D) provided on the inner shaft 48 of the driver 16, which becomes visible through the indicator window 58 as the inner shaft 48 translates with deployment of the spacer 12.
  • the indicator line 68 When in the undeployed configuration as shown in FIG. IA, the indicator line 68 is proximal of the window 58 and therefore not visible through the indicator window 58.
  • the indicator line 68 will enter the indicator window 58 and be visible to the user.
  • An additional alignment line or lines 70 is provided on the proximal end 44 of the handle 24 adjacent to the indicator window 58 as shown in FIGs. IB and 3D.
  • the indicator line 68 on the inner shaft 48 is aligned with the alignment line or lines 70 on the handle 24, a fully deployed configuration of the spacer 12 is indicated providing a visual information of deployment to the surgeon.
  • the above description is one variation of mechanical sensor connected to the instrument for measuring the arrangement of a connected spacer 10.
  • the instrument can be configured with any suitable sensor that can be effectively employed to measure the arrangement of the spacer and provide a signal to the user regarding the arrangement of the connected spacer.
  • suitable sensors include, but are not limited to mechanical, position, optical, electromagnetic, motion, and distance sensors.
  • suitable signals communicating the measured information include audible, visual, tactile signals and the like.
  • the signal may be transmitted to a receiver located on the instrument itself preferable at a location that is resident outside the patient while in use or at a location remote of the instrument.
  • the sensor provides a signal only upon full deployment of the spacer.
  • the sensor provides continuous information as to the arrangment of the spacer.
  • the present invention advantageously provides information regarding the degree of deployment of the spacer to the surgeon which is particularly advantageous in minimally invasive and percutaneous procedures where the device cannot be viewed without the aid of fluoroscopy because of visual obstruction accompanying very small incisions.
  • this invention advantageously reduces time required to implant the spacer and also advantageously reduces the number of fluoroscopy shots that the clinicians and patients are exposed to during the procedure as the deployment information is readily provided to the surgeon by the spacer instrument system with deployment indicator that is located outside patient incision.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L’invention se rapporte à un système à instrument percutané et minimalement invasif servant à implanter un écarteur d’apophyse épineuse chez un patient. Le système à instrument d’insertion comprend un organe d’insertion et un organe d’entraînement. L’organe d’insertion est conçu pour se fixer de manière détachable à un écarteur d’apophyse épineuse pour sa mise en place, son implantation et son déploiement. L’organe d’entraînement est conçu pour l’insertion amovible dans une extrémité proximale d’un passage de l’organe d’insertion. L’organe d’entraînement comporte une partie distale de mise en prise d’écarteur conçue pour mettre en prise la partie de l’écarteur nécessitant l’activation pour le déploiement de l’écarteur depuis au moins une configuration non déployée à au moins une configuration déployée et vice versa. Lorsque l’écarteur passe de la configuration non déployée à la configuration déployée et vice versa, le système fournit avantageusement un degré d’informations de déploiement à l’utilisateur par l’intermédiaire d’au moins un indicateur de déploiement.
EP09718826A 2008-03-12 2009-03-09 Système à instrument écarteur d apophyse épineuse à indicateur de déploiement Withdrawn EP2262434A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6908308P 2008-03-12 2008-03-12
PCT/US2009/036561 WO2009114479A2 (fr) 2008-03-12 2009-03-09 Système à instrument écarteur d’apophyse épineuse à indicateur de déploiement

Publications (1)

Publication Number Publication Date
EP2262434A2 true EP2262434A2 (fr) 2010-12-22

Family

ID=41065782

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09718826A Withdrawn EP2262434A2 (fr) 2008-03-12 2009-03-09 Système à instrument écarteur d apophyse épineuse à indicateur de déploiement

Country Status (5)

Country Link
EP (1) EP2262434A2 (fr)
AU (1) AU2009223607A1 (fr)
CA (1) CA2717315A1 (fr)
IL (1) IL207412A0 (fr)
WO (1) WO2009114479A2 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8167944B2 (en) 2004-10-20 2012-05-01 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8317864B2 (en) 2004-10-20 2012-11-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US7763074B2 (en) 2004-10-20 2010-07-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8152837B2 (en) 2004-10-20 2012-04-10 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8409282B2 (en) 2004-10-20 2013-04-02 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8425559B2 (en) 2004-10-20 2013-04-23 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8123807B2 (en) 2004-10-20 2012-02-28 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8273108B2 (en) 2004-10-20 2012-09-25 Vertiflex, Inc. Interspinous spacer
US9119680B2 (en) 2004-10-20 2015-09-01 Vertiflex, Inc. Interspinous spacer
US8128662B2 (en) 2004-10-20 2012-03-06 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
US9161783B2 (en) 2004-10-20 2015-10-20 Vertiflex, Inc. Interspinous spacer
US9023084B2 (en) 2004-10-20 2015-05-05 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for stabilizing the motion or adjusting the position of the spine
CA2701050A1 (fr) 2004-12-06 2009-07-09 Vertiflex, Inc. Instrument d'insertion d'un ecarteur
US8845726B2 (en) 2006-10-18 2014-09-30 Vertiflex, Inc. Dilator
WO2008130564A1 (fr) 2007-04-16 2008-10-30 Vertiflex Inc. Espaceur interspinal
EP2244670B1 (fr) 2008-01-15 2017-09-13 Vertiflex, Inc. Écarteur interépineux
US8740948B2 (en) 2009-12-15 2014-06-03 Vertiflex, Inc. Spinal spacer for cervical and other vertebra, and associated systems and methods
US9675303B2 (en) 2013-03-15 2017-06-13 Vertiflex, Inc. Visualization systems, instruments and methods of using the same in spinal decompression procedures
AU2015256024B2 (en) 2014-05-07 2020-03-05 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
US12102542B2 (en) 2022-02-15 2024-10-01 Boston Scientific Neuromodulation Corporation Interspinous spacer and methods and systems utilizing the interspinous spacer

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US6733534B2 (en) * 2002-01-29 2004-05-11 Sdgi Holdings, Inc. System and method for spine spacing
US7763028B2 (en) * 2004-02-13 2010-07-27 Warsaw Orthopedic, Inc. Spacer with height and angle adjustments for spacing vertebral members
US8128662B2 (en) * 2004-10-20 2012-03-06 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
US7988709B2 (en) * 2005-02-17 2011-08-02 Kyphon Sarl Percutaneous spinal implants and methods

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Also Published As

Publication number Publication date
CA2717315A1 (fr) 2009-09-17
WO2009114479A2 (fr) 2009-09-17
WO2009114479A3 (fr) 2009-11-05
IL207412A0 (en) 2010-12-30
AU2009223607A1 (en) 2009-09-17

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