WO2009105105A1 - Barre d'union pour ancrages osseux à embout biorésorbable - Google Patents

Barre d'union pour ancrages osseux à embout biorésorbable Download PDF

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Publication number
WO2009105105A1
WO2009105105A1 PCT/US2008/054573 US2008054573W WO2009105105A1 WO 2009105105 A1 WO2009105105 A1 WO 2009105105A1 US 2008054573 W US2008054573 W US 2008054573W WO 2009105105 A1 WO2009105105 A1 WO 2009105105A1
Authority
WO
WIPO (PCT)
Prior art keywords
bioresorbable
tip
rod
connecting rod
bone
Prior art date
Application number
PCT/US2008/054573
Other languages
English (en)
Inventor
Wyatt Drake Geist
Christopher Walsh
Original Assignee
Integrity Intellect, 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 Integrity Intellect, Inc. filed Critical Integrity Intellect, Inc.
Priority to PCT/US2008/054573 priority Critical patent/WO2009105105A1/fr
Publication of WO2009105105A1 publication Critical patent/WO2009105105A1/fr

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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, 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive

Definitions

  • the invention generally relates to surgical implants; particularly to devices for fixation of bony structures and most particularly to a connecting rod for bone anchors suitable for percutaneous insertion and constructed to include a main shaft portion that is not bioresorbable and a tip portion that is bioresorbable.
  • Bone screws are commonly used as fasteners for alignment and fixation of vertebral bodies. These screws are inserted into the spinal pedicle, the bony process projecting backward from the vertebral body, and stabilized with connecting rods placed longitudinally with regard to the vertebrae. Although surgical insertion of pedicle screws has successfully treated non-unions, instability, injuries and disease of the spine, it is not without disadvantages. A serious post-operative complication after insertion of pedicle screws is impingement of the movement of facet joints. Facet joints link the vertebrae together and their hinge-like movement enables flexion (bending forward) and extension (bending backward) of the spine. When pedicle screws are connected the connecting elements are placed within an area that is normally an empty space.
  • Bioresorbable implants have many advantages, such as, versatility (they can be designed for many types of tissue) , predictability (with regard to absorption rates) and strength (during bone healing and/or correction) . Bioresorbable implants do not obscure imaging results (on X-ray, MRI, CT scan) , do not require additional surgery for removal and reduce the risk of implant failure, such as impingement of spinal facet joints.
  • bioresorbable implants may reduce immune reactions and osteolysis of the healing bone that can result with the use of conventional, non-bioresorbable implants .
  • Bone tissue responds well in regions of stress and/or pressure. For example, when stress is reduced or removed by insertion of an implant, the implant bears the entire weight load for the bone as long as it remains inserted. Thus, the bone may not heal properly as the implant is providing the structure that the healed bone should be providing.
  • Bioresorbable implants are ideal in that they avoid this problem by encouraging repair since they resorb as tissue is healing and the tissue gradually lessons dependency on the implant for support.
  • Edwards on January 25, 1983 discloses a spinal fixation device in which sleeves or spacers are placed around or over spinal rods to provide an appropriate fit between the rod and the spine in order to achieve greater pressure and thus greater correction of spinal deformities.
  • These sleeves or spacers are disclosed as having variable thicknesses and are constructed from any biologically compatible material, including bioresorbable materials .
  • US Patent 6,623,484 B2 issued to Betz et al. on September 23, 2003 discloses a method for treatment and correction of spinal deformities without the need for fusion of the intervertebral disk space.
  • a surgical technique is disclosed in which opening and closing osteotomies are created in the affected vertebrae.
  • Correction devices are provided which hold the osteotomies in either the closed or open orientations.
  • These correction devices also include connection members which can be used to engage the devices to an elongated member, such as a spinal rod. Once bone union has occurred in the treated vertebrae, the spinal rod can be disconnected from the correction devices and removed from the patient.
  • the spinal rods are formed of a bioresorbable material to eliminate the need for a second surgery to remove the rod from the patient's body.
  • the disclosed instrument introduces a flexible stabilization element into a patient and secures it to one or more anchors, for example, bone screws.
  • Lim et al . also disclose many embodiments using connecting rods for the anchors (bone screws) .
  • One such connecting rod shown in Figure 38 of the Lim application, includes two distal end portions and a center portion connecting the distal portions.
  • the distal end portions are constructed of a non-bioresorbable metal material and the center connecting portion is constructed of a bioresorbable material.
  • the bioresorbable material is resorbed to release the connection between two adjacent anchors.
  • a trocar provides access to the desired site within a body cavity during a minimally invasive surgical procedure.
  • the obturator, i.e. piercing end, of the trocar penetrates the tissue and is shaped to enlarge the opening created as the trocar is advanced.
  • Bone anchors have been percutaneously placed and connected. Connecting elements have been adapted for such purpose by attaching a trocar-type tip to the distal end of a rod. However, although the tip facilitates the insertion, it performs no other function and remains attached to the connecting rod after placement impinging space and thus movement of the facet joints. A need remains for connecting elements which do not interfere with normal functioning.
  • the instant invention provides connecting elements that are capable of providing effective stabilization while minimizing disruption of normal vertebral functioning. These connecting elements can be percutaneously inserted and are compatible for application with minimally invasive surgical techniques. Although a rod is exemplified herein, other such connecting elements known to one skilled in the art are also contemplated.
  • the connecting rod of the invention is comprised of two portions, a main shaft portion constructed of a non- bioresorbable material and a tip portion constructed of a bioresorbable material.
  • the non-bioresorbable material of the shaft can be, but is not limited to, a metal, such as titanium, stainless steel, or cobalt-chrome alloys or the shaft portion can be porcelain and/or mixtures of all of these materials.
  • bioresorbable material is intended to encompass any nontoxic, non-immunogenic material, natural or synthetic, capable of being formed into a tip which after insertion is gradually hydrolyzed and absorbed over a finite period of time by chemical/biological activity in the body.
  • Illustrative, albeit non-limiting, examples are polylactic acid, polyglycolic acid, polycaprolactone, polyanhydrides, polydioxanone, polyamino acids, trimethylene carbonate, 1 , 5-dioxepan-2-one, copolymers of lactic acid, hydroxyapatite and alginates.
  • the tips of the instant invention can also be made out of bioresorable metals such as magnesium alloys and zinc alloys as described in US Patent 6,854,172 B2 (Kaese et al.) or made out of blends of bioresorbable polymers as described in US Patent 6,583,232 Bl
  • LACTOSORB Wang Surgical, Inc. Jacksonville, FL
  • connecting rod is exemplified for use with vertebral pedicle screws, it is contemplated for use in any bone stabilization procedure where the implant can cause disruption of normal functioning of the affected bone and surrounding tissues.
  • connecting elements for bone anchors that are compatible with minimally invasive technigues and capable of providing effective stabilization, but are less bulky and less disruptive of normal vertebral functioning than the currently available connecting elements. It is an objective of the instant invention to provide a connecting rod for bone anchors comprising at least one bioresorbable part. It is another objective of the instant invention to provide a rod for connecting bone anchors comprising; a shaft portion constructed of a non-bioresorbable material and at least one tip portion constructed of a bioresorbable material.
  • FIGURES IA-B show a side perspective view of vertebral flexion (FIGURE IA) and extension (FIGURE IB) .
  • FIGURE 2 is a posterior view of a pair of lumbar vertebrae .
  • FIGURE 3 is an elevation view of an installation instrument for inserting a connecting rod between two pedicle screws m adjacent vertebrae.
  • FIGURE 4 is a side elevation view of the tip coupled with an interior sectional view of the shaft.
  • FIGURE 5 is a perspective view of a vertebral pair and anchors with the connecting rod positioned for insertion into the passageway through the anchors.
  • the invention provides a connecting rod for bony stabilization devices (also referred to herein as anchors or fasteners) and is compatible for use with minimally invasive surgical techniques.
  • This connecting rod is constructed to include at least two portions; a mam shaft portion that is not bioresorbable and a tip portion that is bioresorbable. After placement of the rod, the bioresorbable tip is resorbed into the patient' s body for reduction of post-operative complications such as impingement of adjacent spinal facet joints .
  • FIG. IA illustrates spinal flexion, i.e. forward movement of a pair of vertebral bodies 1.
  • Facet joints 5 connect upper (superior) vertebral body 2 and lower (inferior) vertebral body 3. Forward movement lifts pedicle 4 upward; direction shown by bolded arrow A.
  • the intervertebral disc 6 is shown between vertebral bodies 2 and 3.
  • Figure IB illustrates spinal extension, i.e. backward movement of the pair of vertebral bodies 1.
  • Facet joints 5 connect upper (superior) vertebral body 2 and lower (inferior) vertebral body 3.
  • Backward movement depresses pedicle 4; direction shown by bolded arrow A.
  • the intervertebral disc 6 is shown between vertebral bodies 2 and 3.
  • Figure 2 shows a posterior view of a pair of lumbar vertebrae. Although lumbar vertebrae are illustrated, the invention can be used with any adjacent vertebrae.
  • the pair of vertebrae 7 is comprised of superior
  • the facet joints 10 between the pair 7 are comprised of inferior facet 11 of superior vertebrae 8, and superior facet 12 of inferior vertebrae 9.
  • the spinous process 13 and the transverse processes 14 are also shown.
  • connecting rods are percutaneously inserted into pedicle screws in a minimally invasive surgical approach using an instrument 15 as shown in Figure 3.
  • a vertebral segment 16 is shown comprising adjacent vertebral bodies 17 separated by disc space 18.
  • Connecting rod 24 includes a shaft 20 having a length between a connecting end 21 and an insertion end 22 sufficient to connect at least two bone anchors 19.
  • the length of shaft 20 is selected to compatible with the method of insertion as percutaneous insertion requires a longer rod.
  • Shaft 20 as shown is an elongated rod curved along its length between ends 21 and 22 with a radius of curvature R.
  • shaft 20 can include any known configuration.
  • Tip 23 coupled to insertion end 22 forms a path through the tissue to facilitate installation of shaft 20 into passageways of anchors engaged to bony structures to stabilize, i.e. fix, the bony structure.
  • the tip 23 is constructed of bioresorbable material and, after a period of time, is resorbed into the body. After resorption of the tip 23, the non- bioresorbable shaft 20 remains, connecting bone anchors 19 between adjacent vertebrae without inhibiting movement.
  • FIG. 4 An embodiment for coupling the bioresorbable tip to the non-bioresorbable shaft is illustrated in Figure 4.
  • a mating threaded attachment 29 is provided between the annulus 28 descending from the tip base 26 and the insertion end 22 of the shaft 20.
  • the annulus portion 28 of the trocar-type tip 25 is threaded 29 and the insertion end 22 of the shaft 20 has mating threads 30 to receive the threads 29 on annulus 28.
  • threads are the exemplified embodiment, other methods for coupling the bioresorbable tip to the non-bioresorbable shaft known to those of skill in the art are contemplated, such as, but not limited to, press fits, locking buttons, locking tapers and laser welding.
  • Figure 5 shows the percutaneous insertion of connecting rod 24 m vertebral segment 16.
  • Anchors 19 are shown installed in adjacent vertebral bodies 17. Instrument 15 guides and positions connecting rod 24 through passage 31 between bone anchors 19. Although the described connecting rod is exemplified for use with vertebral pedicle screws, it is contemplated for use in any percutaneous surgical procedure wherein the cutting tip provides no function other than creating a passageway. All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

Abstract

L'invention concerne une barre d'union pour des ancrages osseux de type vis pédiculaires. Ladite barre comprend une partie barre principale non biorésorbable et une partie embout biorésorbable. L'embout facilite l'insertion percutanée dans le corps d'un patient. Après mise en place de la barre, l'embout biorésorbable se résorbe ce qui permet d'empêcher des complications post-opératoires comme le coincement des facettes vertébrales adjacentes.
PCT/US2008/054573 2008-02-21 2008-02-21 Barre d'union pour ancrages osseux à embout biorésorbable WO2009105105A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2008/054573 WO2009105105A1 (fr) 2008-02-21 2008-02-21 Barre d'union pour ancrages osseux à embout biorésorbable

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2008/054573 WO2009105105A1 (fr) 2008-02-21 2008-02-21 Barre d'union pour ancrages osseux à embout biorésorbable

Publications (1)

Publication Number Publication Date
WO2009105105A1 true WO2009105105A1 (fr) 2009-08-27

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Family Applications (1)

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PCT/US2008/054573 WO2009105105A1 (fr) 2008-02-21 2008-02-21 Barre d'union pour ancrages osseux à embout biorésorbable

Country Status (1)

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WO (1) WO2009105105A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060041259A1 (en) * 2003-05-23 2006-02-23 Paul David C Spine stabilization system
US20070032794A1 (en) * 2005-08-03 2007-02-08 Helmut Weber Process and device for treating vertebral bodies

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060041259A1 (en) * 2003-05-23 2006-02-23 Paul David C Spine stabilization system
US20070032794A1 (en) * 2005-08-03 2007-02-08 Helmut Weber Process and device for treating vertebral bodies

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