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WO2006136938A1 - Interspinous stabilisation device - Google Patents

Interspinous stabilisation device Download PDF

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Publication number
WO2006136938A1
WO2006136938A1 PCT/IB2006/001718 IB2006001718W WO2006136938A1 WO 2006136938 A1 WO2006136938 A1 WO 2006136938A1 IB 2006001718 W IB2006001718 W IB 2006001718W WO 2006136938 A1 WO2006136938 A1 WO 2006136938A1
Authority
WO
WIPO (PCT)
Prior art keywords
ties
opening
tie
teeth
processes
Prior art date
Application number
PCT/IB2006/001718
Other languages
French (fr)
Inventor
Malan De Villiers
Original Assignee
Malan De Villiers
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 Malan De Villiers filed Critical Malan De Villiers
Publication of WO2006136938A1 publication Critical patent/WO2006136938A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7053—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842—Flexible wires, bands or straps

Definitions

  • THIS invention relates to an interspinous stabilisation device.
  • Posterior spinal stabilisation devices are sometimes used by surgeons in cases where fusion or disc replacement is inappropriate or unwarranted.
  • One known class of spinal stabilisation device is installed interspinously, i.e. between the spinous processes of adjacent vertebrae.
  • An example of a known interspinous stabilisation device is the DIAM (Device for Intervertebral Assisted Motion) device produced by the Sofamor Danek division of Medtronic Inc.
  • DIAM Device for Intervertebral Assisted Motion
  • the device includes a resiliently flexible spacer made of medical grade silicone which is implanted between adjacent spinous processes, typically in the lumbar region of the spine, to resist extension and reduce interdiscal pressure.
  • the spacer which is typically encapsulated in a flexible sheath providing protection against abrasive wear from the spinous processes, has upper and lower notched edges to receive the respective processes and is tethered in place by means of separate, flexible cords which are tied about the processes or passed about the processes and tied to one another.
  • the tethering of the spacer using these cords is a time-consuming and inconvenient procedure, and may in some cases require suturing of the cords to adjacent ligamentous structures of the spine.
  • Another example of interspinous stabilisation device is the so-called Walllis Cage produced by Spine Next, SA. It includes a moulded plastics body, typically of PEEKTM which is positioned between the spinous processes. Like the DIAM device the Wallis Cage is tethered in position by means of an anchoring clip and cords which are tied about the processes.
  • the tethering procedure suffers from similar problems to those experienced in DIAM implantation.
  • Fixano interspinous fixation system produced by Fixano SA.
  • This device has a U-shaped body made of titanium which is implanted between the spinous processes. Wings or lugs projecting upwardly and downwardly from respective legs of the Li- shape are clamped to the respective processes to hold the body in position. Once again, installation and fixation of the device are time-consuming and inconvenient procedures.
  • the stabilisation device is placed in position posteriorly and can, as a result, cause damage to or even destroy the interspinous process ligament.
  • an interspinous stabilisation device comprising:
  • a resiliency flexible, moulded plastics body shaped and dimensioned to be located between adjacent spinous processes in order to provide support between the associated vertebrae, and - elongate, flexible ties carried in use by the body, the ties being arranged to be looped over the respective processes and engaged in one or more openings associated with the body.
  • the body includes an operatively upwardly facing notch therein and an operatively downwardly facing notch therein and is shaped for reception of respective spinous processes in the notches when the body is placed between such processes.
  • the notches are defined between a pair of operatively upwardly facing projections on the body and a pair of operatively downwardly facing projections on the body, respectively.
  • the body may have a bow-tie like shape.
  • the ties are moulded integrally with the body and the body may be moulded with at least one tie-receiving opening therein.
  • the ties are preferably engagable in the opening(s) by interaction of teeth on the ties with tooth-engaging pawls associated with the opening(s).
  • the teeth are typically of ratchet form and the pawls are arranged to engage with the teeth, when the ties are passed through the opening(s), in a manner preventing withdrawal of the ties through the opening(s).
  • the body has a pair of openings therein, one for each tie, and each opening has a pawl associated therewith to engage the teeth on a respective tie.
  • the body be sufficiently resiliently flexible to be compressed vertically to an extent allowing lateral insertion of the body between adjacent spinous processes.
  • Figure 1 shows a perspective view of an interspinous stabilisation device according to this invention
  • Figure 2 shows how ties can be looped over and engaged with the body of the device seen in Figure 1 ;
  • Figure 3 illustrates the use of the device in a posterior view of a spine segment.
  • the interspinous stabilisation device 10 seen in Figure 1 has a central body 12 with a pair of ties 14 extending from the body in opposite directions.
  • the body and ties are formed integrally, as a one-piece moulding, of a resilient plastics material, in this case a radiation cross-linked LDPE (low density polyethylene).
  • LDPE low density polyethylene
  • the body 12 has a bow-tie like shape and includes pairs of opposed projections 16 which define intermediate notches 18 facing in opposite directions. Openings 20 extend centrally through the body in a side by side relationship with a web of material 22 between the openings. Extending inwardly from opposite sides of the openings 20 are pawls 24 having hook formations at their ends.
  • the ties 14 are formed with ratchet-like teeth 28 along their lengths and terminate at their extremities in toothless end regions 29.
  • each tie 14 can be looped over and passed through a respective opening 20, with the pawl associated with that opening allowing passage of the tie as indicated by the arrow 30.
  • the hook formation of the pawl, while allowing passage of the teeth in the direction 30, interacts with the teeth in a manner to prevent withdrawal of the tie through the opening in the opposite direction 32, as will be apparent from the enlargement in Figure 2.
  • the end regions 29 facilitate initial entry of the ties into the openings.
  • the body 12 is implanted posteriorly between the spinous processes 36 of adjacent vertebrae 38 in a spine after appropriate distraction of those vertebrae.
  • the body is oriented such that the processes locate in the notches 18.
  • body 12 is accurately dimensioned for proper location between the processes, although it would of course be possible to have different devices 10, with bodies 12 of different size, to suit different applications and spinal segments.
  • the invention envisages that the material of which the device 10 is made will have sufficient flexibility to allow posterior-lateral placement of the body 12, thereby leaving the interspinous process ligament intact.
  • the projections 16 should be sufficiently resiliently deformable to allow them to pass the spinous processes with a lateral component of movement, thereby avoiding potentially damaging contact with the ligament.
  • the ties are looped over the respective spinous processes and are then fed through the respective openings 20 and pulled tight whereafter the ends of the ties can be cut off and disposed of.
  • the pawls 24, by preventing subsequent withdrawal of the ties through the openings, ensure that the device 10 is firmly anchored in position.
  • An advantage of the illustrated device 10 is the speed and simplicity of the fastening procedure compared to the conventional DIAM, Wallis Cage and Fixano devices mentioned earlier.

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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

The invention concerns an interspinous stabilisation device (10) which is located between the spinous processes of adjacent spinal vertebrae to provide support between the vertebrae and to stabilise the spinal section. The device has a resiliently flexible, moulded plastics body shaped and dimensioned to be located between the adjacent spinous processes. It also has elongate, flexible ties carried by the body. These ties are arranged to be looped over the respective processes and to be engaged in opening(s) associated with the body. The body is typically bow-tie shaped and the ties are moulded integrally with it. The ties can be engaged in the opening(s) by interaction of teeth on the ties with tooth-engaging pawls in the opening(s).

Description

"INTERSPINOUS STABILISATION DEVICE"
BACKGROUND TO THE INVENTION
THIS invention relates to an interspinous stabilisation device.
Posterior spinal stabilisation devices are sometimes used by surgeons in cases where fusion or disc replacement is inappropriate or unwarranted. One known class of spinal stabilisation device is installed interspinously, i.e. between the spinous processes of adjacent vertebrae.
An example of a known interspinous stabilisation device is the DIAM (Device for Intervertebral Assisted Motion) device produced by the Sofamor Danek division of Medtronic Inc. This is a flexible spinal implant designed to provide support between posterior elements of the spine, namely the spinous processes of adjacent vertebrae, and thereby relieve pain caused by degenerative spinal diseases. The device includes a resiliently flexible spacer made of medical grade silicone which is implanted between adjacent spinous processes, typically in the lumbar region of the spine, to resist extension and reduce interdiscal pressure. The spacer, which is typically encapsulated in a flexible sheath providing protection against abrasive wear from the spinous processes, has upper and lower notched edges to receive the respective processes and is tethered in place by means of separate, flexible cords which are tied about the processes or passed about the processes and tied to one another. The tethering of the spacer using these cords is a time-consuming and inconvenient procedure, and may in some cases require suturing of the cords to adjacent ligamentous structures of the spine. Another example of interspinous stabilisation device is the so-called Walllis Cage produced by Spine Next, SA. It includes a moulded plastics body, typically of PEEK™ which is positioned between the spinous processes. Like the DIAM device the Wallis Cage is tethered in position by means of an anchoring clip and cords which are tied about the processes. The tethering procedure suffers from similar problems to those experienced in DIAM implantation.
Yet another interspinous stabilisation device is the Fixano interspinous fixation system produced by Fixano SA. This device has a U-shaped body made of titanium which is implanted between the spinous processes. Wings or lugs projecting upwardly and downwardly from respective legs of the Li- shape are clamped to the respective processes to hold the body in position. Once again, installation and fixation of the device are time-consuming and inconvenient procedures.
In each of the above cases, the stabilisation device is placed in position posteriorly and can, as a result, cause damage to or even destroy the interspinous process ligament.
It is an objective of the present invention to provide an alternative interspinous stabilisation device which can be implanted and fixed in position relatively quickly and easily.
SUMMARY OF THE INVENTION
According to the present invention there is provided an interspinous stabilisation device comprising:
- a resiliency flexible, moulded plastics body shaped and dimensioned to be located between adjacent spinous processes in order to provide support between the associated vertebrae, and - elongate, flexible ties carried in use by the body, the ties being arranged to be looped over the respective processes and engaged in one or more openings associated with the body.
In the preferred embodiment, the body includes an operatively upwardly facing notch therein and an operatively downwardly facing notch therein and is shaped for reception of respective spinous processes in the notches when the body is placed between such processes. Conveniently the notches are defined between a pair of operatively upwardly facing projections on the body and a pair of operatively downwardly facing projections on the body, respectively. Thus the body may have a bow-tie like shape.
The ties are moulded integrally with the body and the body may be moulded with at least one tie-receiving opening therein.
The ties are preferably engagable in the opening(s) by interaction of teeth on the ties with tooth-engaging pawls associated with the opening(s). In this case, the teeth are typically of ratchet form and the pawls are arranged to engage with the teeth, when the ties are passed through the opening(s), in a manner preventing withdrawal of the ties through the opening(s).
Conveniently, the body has a pair of openings therein, one for each tie, and each opening has a pawl associated therewith to engage the teeth on a respective tie.
It is preferred that the body be sufficiently resiliently flexible to be compressed vertically to an extent allowing lateral insertion of the body between adjacent spinous processes.
Other features of the invention are described below and are set forth in the appended claims. BRlEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in more detail, by way of example only, with reference to the accompanying drawings in which:
Figure 1 shows a perspective view of an interspinous stabilisation device according to this invention;
Figure 2 shows how ties can be looped over and engaged with the body of the device seen in Figure 1 ; and
Figure 3 illustrates the use of the device in a posterior view of a spine segment.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
The interspinous stabilisation device 10 seen in Figure 1 has a central body 12 with a pair of ties 14 extending from the body in opposite directions. The body and ties are formed integrally, as a one-piece moulding, of a resilient plastics material, in this case a radiation cross-linked LDPE (low density polyethylene).
As illustrated the body 12 has a bow-tie like shape and includes pairs of opposed projections 16 which define intermediate notches 18 facing in opposite directions. Openings 20 extend centrally through the body in a side by side relationship with a web of material 22 between the openings. Extending inwardly from opposite sides of the openings 20 are pawls 24 having hook formations at their ends.
The ties 14 are formed with ratchet-like teeth 28 along their lengths and terminate at their extremities in toothless end regions 29. In use, as illustrated in Figure 2, each tie 14 can be looped over and passed through a respective opening 20, with the pawl associated with that opening allowing passage of the tie as indicated by the arrow 30. However the hook formation of the pawl, while allowing passage of the teeth in the direction 30, interacts with the teeth in a manner to prevent withdrawal of the tie through the opening in the opposite direction 32, as will be apparent from the enlargement in Figure 2. The end regions 29 facilitate initial entry of the ties into the openings.
It will be recognised that the combination of a tie 14, opening 20 and pawl 24 can be likened to the structure of a conventional, so-called "cable tie".
In other embodiments, not illustrated, there may be multiple pawls 24 in each opening 20, the pawls being arranged to engage spaced apart teeth on the ties 14 thereby to increase the security with which the ties are engaged.
In use, the body 12 is implanted posteriorly between the spinous processes 36 of adjacent vertebrae 38 in a spine after appropriate distraction of those vertebrae. The body is oriented such that the processes locate in the notches 18.
It will be understood that the body 12 is accurately dimensioned for proper location between the processes, although it would of course be possible to have different devices 10, with bodies 12 of different size, to suit different applications and spinal segments.
The invention envisages that the material of which the device 10 is made will have sufficient flexibility to allow posterior-lateral placement of the body 12, thereby leaving the interspinous process ligament intact. In particular the projections 16 should be sufficiently resiliently deformable to allow them to pass the spinous processes with a lateral component of movement, thereby avoiding potentially damaging contact with the ligament. After location of the body 12, the ties are looped over the respective spinous processes and are then fed through the respective openings 20 and pulled tight whereafter the ends of the ties can be cut off and disposed of. The pawls 24, by preventing subsequent withdrawal of the ties through the openings, ensure that the device 10 is firmly anchored in position.
An advantage of the illustrated device 10 is the speed and simplicity of the fastening procedure compared to the conventional DIAM, Wallis Cage and Fixano devices mentioned earlier.
Numerous variations are possible. It would for instance be possible to have a single opening in the body 12 to receive both ties, with pawls projecting into the opening in opposite directions. It would also be possible for the body 12 and ties to be separately manufactured, or for the device to include a body and separately manufactured cable ties which are connected to the body when the body is implanted between the spinous processes.

Claims

1.
An interspinous stabilisation device comprising:
a resiliently flexible, moulded plastics body shaped and dimensioned to be located between adjacent spinous processes in order to provide support between the associated vertebrae, and
elongate, flexible ties carried in use by the body, the ties being arranged to be looped over the respective processes and engaged in one or more openings associated with the body.
2.
A device according to claim 1 wherein the body includes an operatively upwardly facing notch therein and an operatively downwardly facing notch therein and is shaped for reception of respective spinous processes in the notches when the body is placed between such processes.
3.
A device according to claim 2 wherein the notches are defined between a pair of operatively upwardly facing projections on the body and a pair of operatively downwardly facing projections on the body, respectively.
4.
A device according to claim 3 wherein the body has a bow-tie like shape.
5.
A device according to any one of the preceding claims wherein the ties are moulded integrally with the body.
6.
A device according to any one of the preceding claims wherein the body is moulded with at least one tie-receiving opening therein.
7.
A device according to any one of the preceding claims wherein the ties are engagable in the opening(s) by interaction of teeth on the ties with tooth- engaging pawls associated with the opening(s).
8.
A device according to claim 7 wherein the teeth are of ratchet form and the pawls are arranged to engage with the teeth, when the ties are passed through the opening(s), in a manner preventing withdrawal of the ties through the opening(s).
9.
A device according to claim 8 wherein the body has a pair of openings therein, one for each tie, each opening having a pawl associated therewith to engage the teeth on a respective tie.
10.
A device according to any one of the preceding claims wherein the body is sufficiently resiliently flexible to be compressed vertically to an extent allowing lateral insertion of the body between adjacent spinous processes.
PCT/IB2006/001718 2005-06-24 2006-06-23 Interspinous stabilisation device WO2006136938A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA2005/05135 2005-06-24
ZA200505135 2005-06-24

Publications (1)

Publication Number Publication Date
WO2006136938A1 true WO2006136938A1 (en) 2006-12-28

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010045491A1 (en) * 2008-10-15 2010-04-22 Replication Medical, Inc. Swellable interspinous stabilization implant
US8231626B2 (en) 2009-05-12 2012-07-31 Synthes Usa, Llc Self-retaining cable tie
AT512723A1 (en) * 2012-03-20 2013-10-15 Frank Cerclagenband
US9084644B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
US9474553B2 (en) 2013-01-25 2016-10-25 DePuy Synthes Products, Inc. Caps for implants, implant assemblies, and methods of use
US9585705B2 (en) 2012-03-28 2017-03-07 DePuy Synthes Products, Inc. Bone fixation member systems and methods of use
US9603646B2 (en) 2014-05-30 2017-03-28 DePuy Synthes Products, Inc. Bone fixation assembly
US9814496B2 (en) 2015-09-15 2017-11-14 Hydra Medical, LLC Interspinous stabilization implant
AU2016238296B2 (en) * 2015-03-25 2018-06-14 Coracoid Solutions, Llc Joint repair system
JP7499422B2 (en) 2021-02-09 2024-06-13 ジンマー バイオメット シーエムエフ アンド ソラシック，リミティド ライアビリティ カンパニー Strong sternal fixation

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2717675A1 (en) * 1994-03-24 1995-09-29 Taylor Jean Shock-absorbing spacer block for location between adjacent vertebrae implanted during spinal surgery
US5462542A (en) * 1994-01-24 1995-10-31 United States Surgical Corporation Sternum buckle with serrated strap
FR2799640A1 (en) * 1999-10-15 2001-04-20 Spine Next Sa Intervertebral implant has wedge with opposed recesses to receive spinous processes and retained by strap
WO2002003882A2 (en) * 2000-07-12 2002-01-17 Spine Next Shock-absorbing intervertebral implant
WO2002051326A1 (en) * 2000-12-22 2002-07-04 Spine Next Intervertebral implant with deformable wedge

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5462542A (en) * 1994-01-24 1995-10-31 United States Surgical Corporation Sternum buckle with serrated strap
FR2717675A1 (en) * 1994-03-24 1995-09-29 Taylor Jean Shock-absorbing spacer block for location between adjacent vertebrae implanted during spinal surgery
FR2799640A1 (en) * 1999-10-15 2001-04-20 Spine Next Sa Intervertebral implant has wedge with opposed recesses to receive spinous processes and retained by strap
WO2002003882A2 (en) * 2000-07-12 2002-01-17 Spine Next Shock-absorbing intervertebral implant
WO2002051326A1 (en) * 2000-12-22 2002-07-04 Spine Next Intervertebral implant with deformable wedge

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9131965B2 (en) 2008-10-15 2015-09-15 Replication Medical Inc. Swellable interspinous stabilization implant
WO2010045491A1 (en) * 2008-10-15 2010-04-22 Replication Medical, Inc. Swellable interspinous stabilization implant
US8231626B2 (en) 2009-05-12 2012-07-31 Synthes Usa, Llc Self-retaining cable tie
US10307196B2 (en) 2011-02-02 2019-06-04 DePuy Synthes Products, Inc. Bone fixation assembly
US9084645B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
US9084644B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
AT512723A1 (en) * 2012-03-20 2013-10-15 Frank Cerclagenband
AT512723B1 (en) * 2012-03-20 2014-04-15 Claudia Mag Frank Cerclagenband
US9585705B2 (en) 2012-03-28 2017-03-07 DePuy Synthes Products, Inc. Bone fixation member systems and methods of use
US9474553B2 (en) 2013-01-25 2016-10-25 DePuy Synthes Products, Inc. Caps for implants, implant assemblies, and methods of use
US9603646B2 (en) 2014-05-30 2017-03-28 DePuy Synthes Products, Inc. Bone fixation assembly
US10433890B2 (en) 2015-03-25 2019-10-08 Coracoid Solutions, Llc Joint repair system
AU2016238296B2 (en) * 2015-03-25 2018-06-14 Coracoid Solutions, Llc Joint repair system
US10470808B2 (en) 2015-03-25 2019-11-12 Coracoid Solutions, Llc Joint repair system
US11564722B2 (en) 2015-03-25 2023-01-31 Coracoid Solutions, Llc Joint repair system
US9814496B2 (en) 2015-09-15 2017-11-14 Hydra Medical, LLC Interspinous stabilization implant
JP7499422B2 (en) 2021-02-09 2024-06-13 ジンマー バイオメット シーエムエフ アンド ソラシック，リミティド ライアビリティ カンパニー Strong sternal fixation

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