WO2010141402A1 - Programmable fluid actuated spinal implant having a post-operative adjustable dimension - Google Patents

Programmable fluid actuated spinal implant having a post-operative adjustable dimension Download PDF

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Publication number
WO2010141402A1
WO2010141402A1 PCT/US2010/036804 US2010036804W WO2010141402A1 WO 2010141402 A1 WO2010141402 A1 WO 2010141402A1 US 2010036804 W US2010036804 W US 2010036804W WO 2010141402 A1 WO2010141402 A1 WO 2010141402A1
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WO
WIPO (PCT)
Prior art keywords
spinal
spinal implant
post
elements
piston
Prior art date
Application number
PCT/US2010/036804
Other languages
French (fr)
Inventor
Uri Arnin
Original Assignee
Spine21 Ltd.
Klein, David
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 Spine21 Ltd., Klein, David filed Critical Spine21 Ltd.
Publication of WO2010141402A1 publication Critical patent/WO2010141402A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7014Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks
    • A61B17/7017Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks pneumatic or hydraulic means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/48Operating or control means, e.g. from outside the body, control of sphincters
    • A61F2/484Fluid means, i.e. hydraulic or pneumatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/3055Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting length
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30668Means for transferring electromagnetic energy to implants
    • A61F2002/3067Means for transferring electromagnetic energy to implants for data transfer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001Means for transferring electromagnetic energy to implants
    • A61F2250/0002Means for transferring electromagnetic energy to implants for data transfer

Definitions

  • the present invention relates generally to spinal implants and prostheses, and particularly to a spinal implant having a post-operative adjustable dimension.
  • Spinal stenosis as well as spondylosis, spondylolisthesis, osteoarthritis, scoliosis and other degenerative phenomena may be the cause of back pain, and may be caused by a narrowing of the spinal canal or foramina that result in stress acting on the spinal cord and/or nerve roots.
  • One of the methods for resolving back pain involves decompression, the removal of bony elements causing the pain, and fusion of two or more adjacent vertebrae.
  • fusion tends to have significant shortcoming and may cause the problem to migrate to adjacent vertebral components.
  • non-fusion solutions are disc replacement, dynamic stabilization systems and inter-spinous process implants.
  • US Patents 6045579, 6080193 and 6576016 to Hochshuler et al describe an adjustable height fusion device for promoting a spinal fusion between neighboring vertebrae.
  • the device is located within the intervertebral disc space and includes a pair of engaging plates for contacting the vertebrae.
  • An alignment device is used to alter the vertical distance between the engaging plates to customize the apparatus to fit a given patient.
  • the alignment device includes a pair of struts having a predetermined height and extending between the engaging plates from an anterior end to a posterior end of the apparatus.
  • the alignment device includes a rotatable connector and cam pins for adjusting the distance between the engaging plates.
  • the alignment device is preferably adapted to vary the distance between the engaging plates such that the height of the apparatus proximate the anterior end is greater than that proximate the posterior end whereby the natural lordosis of the spine is maintained after the apparatus is installed.
  • the present invention seeks to provide an improved spinal implant (or prosthesis, the terms being used interchangeably) having a post-operative adjustable dimension, fluid-activated (e.g., hydraulically or pneumatically) using an implanted pump, as described in more detail further below.
  • At least one of its dimensions of the spinal implant can be modified post-implantation by means of remote control.
  • the adjustable portion also referred to as a variable dimension mechanism
  • the pump can be electrically powered, such as by an electric motor (powered by a battery or remote induction), and controlled via remote control.
  • the prosthesis is configured to bridge between two vertebrae, most preferably but not limited to, adjacent vertebrae.
  • the prosthesis includes a plurality of attachment members (end features) configured to be attached to a plurality of bone attachment points, such as but not limited to, spinous process, vertebral end plates or pedicles (via pedicle screws).
  • a spinal implant including first spinal attachment member for attaching to a first spinal portion, second spinal attachment member for attaching to a second spinal portion, and a fluid actuated (hydraulic or pneumatic) post-implantation variable dimension device disposed between the first and second spinal attachment members, which is operable after completing surgery in which said spinal implant was installed into a patient, to cause relative movement between the first and second spinal attachment members.
  • first and second spinal attachment members include pedicle screws.
  • Fig. 1 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with an embodiment of the invention, implanted between two adjacent spinous processes;
  • Fig. 2 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with another embodiment of the invention, connected to pedicle screws so that actuating the variable dimension mechanism can change the distance between the screws;
  • Fig. 3 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with yet another embodiment of the invention, inserted in between two adjacent vertebrae;
  • Fig. 4 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with an embodiment of the invention
  • Fig. 5 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with another embodiment of the invention.
  • Fig. 6 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with yet another embodiment of the invention.
  • FIG. 1 illustrates a spinal implant 10, constructed and operative in accordance with an embodiment of the invention.
  • Spinal implant 10 is shown implanted between two adjacent spinous processes of the lumbar spine (in this example, spinal implant 10 is an interspinous process device).
  • Spinal implant 10 includes a post-implantation variable dimension device 12 disposed between a first (upper) support end plate (spinal attachment member) 14 and a second (lower) support end plate (spinal attachment member) 16.
  • the post-implantation variable dimension device 12 may include a post arranged for linear motion (slightly tilted from vertical in the sense of the drawing), such as by means of a miniature linear actuator which is remote controlled.
  • post-implantation variable dimension device 12 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6.
  • Fig. 2 illustrates a spinal implant 20, constructed and operative in accordance with another embodiment of the invention.
  • Spinal implant 20 includes a post-implantation variable dimension device 22, and is connected to pedicle screws 24 (spinal attachment members 24). Actuation of variable dimension device 22 changes the distance between screws 24.
  • post-implantation variable dimension device 22 may include a post arranged for linear motion, such as by means of a miniature linear actuator which is remote controlled.
  • post-implantation variable dimension device 22 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6. Reference is now made to Fig.
  • FIG. 3 which illustrates a spinal implant 30 including a post-implantation variable dimension device 32, constructed and operative in accordance with yet another embodiment of the invention, inserted in between two adjacent vertebrae (e.g., L4 and L5).
  • Spinal implant 30 includes a first (upper) support plate 34 connected to and supporting an upper vertebra, and a second (lower) support plate 36 connected to and supporting a lower vertebra.
  • the variable dimension device 32 is installed between first and second support plates (spinal attachment members) 34 and 36. Actuation of variable dimension device 32 changes the distance between first and second support plates 34 and 36, and can change the location between the two adjacent vertebrae both in the vertical and the sagittal planes.
  • post-implantation variable dimension device 32 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6.
  • Variable dimension device 60 includes two end plates (spinal attachment members) 61 and 62, both attached to a piston 63.
  • Piston 63 is fluidly actuated (that is, either hydraulically or pneumatically), such as by means of compressed liquid (e.g., water) or gas (e.g., air).
  • compressed liquid e.g., water
  • gas e.g., air
  • FIG. 5 illustrates a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device 70, constructed and operative in accordance with another embodiment of the invention.
  • Device 70 includes a piston 41 located between two spinal elements 37 and 38 supported by two attachment members 39 and 40.
  • attachment members 39 and 40 have a curved cross-sectional shape (e.g., U-shaped, half-circle, half-ellipse, etc.).
  • a pump unit 42 which may contain an internal or external fluid reservoir, is connected to piston 41 via a tube 43.
  • the pump unit 42 is implanted in the body as well.
  • FIG. 6 illustrates a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device 80, constructed and operative in accordance with yet another embodiment of the invention.
  • Device 80 includes a piston 49 located between two spinal elements 45 and 46 supported by two attachment members 47 and 48.
  • piston 49 is not located between the spinal elements 45 and 46; instead it is located adjacent spinal elements 45 and 46.
  • An implanted pump unit 50 which may contain an internal or external fluid reservoir, is connected to piston 49 via a tube 51.
  • the pump unit 50 and the piston 49 may straddle (and may or may not abut) outer portions of the spinal elements 45 and 46.
  • the attachment members 47 and 48 each include a first portion 81, which contacts the spinal elements 45 and 46, from which extends a second portion 82 not located between the spinal elements 45 and 46 upon which piston 49 acts to vary the distance between spinal elements 45 and 46.
  • External controller 89 operates the implanted pump units of any of the embodiments of the invention.
  • External controller 89 may include a control panel, a processor, an RF transmitter/emitter, a magnetic power source, an electric coil, a cellular communication device and any combination thereof.
  • the pump may be actuated electronically, magnetically, by RF signals, etc.
  • the communication between the external control portion and the implanted pump may be controlled by a code or password to protect against undesired operation of the internal device.
  • the implanted pump unit 50 may include a microprocessor 91, transceiver 92, and/or battery 93 built into the unit.
  • the microprocessor 91 may be used to process instructions or any other kind of information sent to pump unit 50 by the external controller 89 or received therefrom via the transceiver 92.

Abstract

A spinal implant including first spinal attachment member (47) for attaching to a first spinal portion (45), second spinal attachment member (48) for attaching to a second spinal portion (46), and a fluid actuated (hydraulic or pneumatic) post-implantation variable dimension device (49) disposed between the first and second spinal attachment members (47,48), which is operable after completing surgery in which said spinal implant was installed into a patient, to cause relative movement between the first and second spinal attachment members.

Description

PROGRAMABLE FLUID ACTUATED SPINAL IMPLANT HAVING A POSTOPERATIVE ADJUSTABLE DIMENSION HELD OF THE INVENTION
The present invention relates generally to spinal implants and prostheses, and particularly to a spinal implant having a post-operative adjustable dimension.
BACKGROUND OF THE INVENTION
Spinal stenosis, as well as spondylosis, spondylolisthesis, osteoarthritis, scoliosis and other degenerative phenomena may be the cause of back pain, and may be caused by a narrowing of the spinal canal or foramina that result in stress acting on the spinal cord and/or nerve roots.
One of the methods for resolving back pain involves decompression, the removal of bony elements causing the pain, and fusion of two or more adjacent vertebrae. Unfortunately, fusion tends to have significant shortcoming and may cause the problem to migrate to adjacent vertebral components. Among the non-fusion solutions are disc replacement, dynamic stabilization systems and inter-spinous process implants.
Spinal implants with the capability of height adjustment are known. For example, US Patents 6045579, 6080193 and 6576016 to Hochshuler et al (issued April 4, 2000, June 27, 2000 and June 10, 2003, respectively) describe an adjustable height fusion device for promoting a spinal fusion between neighboring vertebrae. The device is located within the intervertebral disc space and includes a pair of engaging plates for contacting the vertebrae. An alignment device is used to alter the vertical distance between the engaging plates to customize the apparatus to fit a given patient. In one embodiment, the alignment device includes a pair of struts having a predetermined height and extending between the engaging plates from an anterior end to a posterior end of the apparatus. In another embodiment, the alignment device includes a rotatable connector and cam pins for adjusting the distance between the engaging plates. The alignment device is preferably adapted to vary the distance between the engaging plates such that the height of the apparatus proximate the anterior end is greater than that proximate the posterior end whereby the natural lordosis of the spine is maintained after the apparatus is installed.
However, these prior art devices must be adjusted prior to or during the installation and are not capable of post-operative adjustment.
SUMMARY OF THE INVENTION
The present invention seeks to provide an improved spinal implant (or prosthesis, the terms being used interchangeably) having a post-operative adjustable dimension, fluid-activated (e.g., hydraulically or pneumatically) using an implanted pump, as described in more detail further below.
In one embodiment, at least one of its dimensions of the spinal implant can be modified post-implantation by means of remote control. The adjustable portion (also referred to as a variable dimension mechanism) can have a piston-like configuration hydraulically or pneumatically activated by a small implanted pump. The pump can be electrically powered, such as by an electric motor (powered by a battery or remote induction), and controlled via remote control.
The prosthesis is configured to bridge between two vertebrae, most preferably but not limited to, adjacent vertebrae. The prosthesis includes a plurality of attachment members (end features) configured to be attached to a plurality of bone attachment points, such as but not limited to, spinous process, vertebral end plates or pedicles (via pedicle screws).
There is thus provided in accordance with a non-limiting embodiment of the present invention a spinal implant including first spinal attachment member for attaching to a first spinal portion, second spinal attachment member for attaching to a second spinal portion, and a fluid actuated (hydraulic or pneumatic) post-implantation variable dimension device disposed between the first and second spinal attachment members, which is operable after completing surgery in which said spinal implant was installed into a patient, to cause relative movement between the first and second spinal attachment members.
In accordance with an embodiment of the present invention the first and second spinal attachment members include pedicle screws.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
Fig. 1 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with an embodiment of the invention, implanted between two adjacent spinous processes;
Fig. 2 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with another embodiment of the invention, connected to pedicle screws so that actuating the variable dimension mechanism can change the distance between the screws; Fig. 3 is a simplified pictorial illustration of a spinal implant including a post- implantation variable dimension device, constructed and operative in accordance with yet another embodiment of the invention, inserted in between two adjacent vertebrae;
Fig. 4 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with an embodiment of the invention;
Fig. 5 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with another embodiment of the invention; and
Fig. 6 is a simplified pictorial illustration of a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device, constructed and operative in accordance with yet another embodiment of the invention. DETAILED DESCRIPTION OF EMBODIMENTS
Reference is now made to Fig. 1, which illustrates a spinal implant 10, constructed and operative in accordance with an embodiment of the invention.
Spinal implant 10 is shown implanted between two adjacent spinous processes of the lumbar spine (in this example, spinal implant 10 is an interspinous process device). Spinal implant 10 includes a post-implantation variable dimension device 12 disposed between a first (upper) support end plate (spinal attachment member) 14 and a second (lower) support end plate (spinal attachment member) 16. The post-implantation variable dimension device 12 may include a post arranged for linear motion (slightly tilted from vertical in the sense of the drawing), such as by means of a miniature linear actuator which is remote controlled. In general, post-implantation variable dimension device 12 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6.
Reference is now made to Fig. 2, which illustrates a spinal implant 20, constructed and operative in accordance with another embodiment of the invention. Spinal implant 20 includes a post-implantation variable dimension device 22, and is connected to pedicle screws 24 (spinal attachment members 24). Actuation of variable dimension device 22 changes the distance between screws 24. Here too, post-implantation variable dimension device 22 may include a post arranged for linear motion, such as by means of a miniature linear actuator which is remote controlled. In general, post-implantation variable dimension device 22 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6. Reference is now made to Fig. 3, which illustrates a spinal implant 30 including a post-implantation variable dimension device 32, constructed and operative in accordance with yet another embodiment of the invention, inserted in between two adjacent vertebrae (e.g., L4 and L5). Spinal implant 30 includes a first (upper) support plate 34 connected to and supporting an upper vertebra, and a second (lower) support plate 36 connected to and supporting a lower vertebra. The variable dimension device 32 is installed between first and second support plates (spinal attachment members) 34 and 36. Actuation of variable dimension device 32 changes the distance between first and second support plates 34 and 36, and can change the location between the two adjacent vertebrae both in the vertical and the sagittal planes. In general, post-implantation variable dimension device 32 may be constructed in accordance with any of the embodiments described below with reference to Figs. 4-6.
Reference is now made to Fig. 4, which illustrates a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device 60, constructed and operative in accordance with an embodiment of the invention. Variable dimension device 60 includes two end plates (spinal attachment members) 61 and 62, both attached to a piston 63. Piston 63 is fluidly actuated (that is, either hydraulically or pneumatically), such as by means of compressed liquid (e.g., water) or gas (e.g., air). The compressed fluid is introduced to piston 63 by means of a tube 64 which is connected to a fluid inlet 65.
Reference is now made to Fig. 5, which illustrates a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device 70, constructed and operative in accordance with another embodiment of the invention. Device 70 includes a piston 41 located between two spinal elements 37 and 38 supported by two attachment members 39 and 40. In contrast with the flat plates 61 and 62 of the embodiment of Fig. 4, in this embodiment, attachment members 39 and 40 have a curved cross-sectional shape (e.g., U-shaped, half-circle, half-ellipse, etc.). A pump unit 42, which may contain an internal or external fluid reservoir, is connected to piston 41 via a tube 43. In contrast with the embodiment of Fig. 4, the pump unit 42 is implanted in the body as well.
Reference is now made to Fig. 6, which illustrates a fluid-operated (hydraulically or pneumatically operated) post-implantation variable dimension device 80, constructed and operative in accordance with yet another embodiment of the invention. Device 80 includes a piston 49 located between two spinal elements 45 and 46 supported by two attachment members 47 and 48. In contrast with the previous embodiments, in this embodiment, piston 49 is not located between the spinal elements 45 and 46; instead it is located adjacent spinal elements 45 and 46. An implanted pump unit 50, which may contain an internal or external fluid reservoir, is connected to piston 49 via a tube 51. The pump unit 50 and the piston 49 may straddle (and may or may not abut) outer portions of the spinal elements 45 and 46. The attachment members 47 and 48 each include a first portion 81, which contacts the spinal elements 45 and 46, from which extends a second portion 82 not located between the spinal elements 45 and 46 upon which piston 49 acts to vary the distance between spinal elements 45 and 46.
An external (i.e., external to the patient's body) controller 89, shown in Fig. 6 and applicable for any of the embodiments of the invention, operates the implanted pump units of any of the embodiments of the invention. External controller 89 may include a control panel, a processor, an RF transmitter/emitter, a magnetic power source, an electric coil, a cellular communication device and any combination thereof. (Accordingly, the pump may be actuated electronically, magnetically, by RF signals, etc.) The communication between the external control portion and the implanted pump may be controlled by a code or password to protect against undesired operation of the internal device.
As seen in Fig. 6 (again applicable for any of the embodiments of the invention), the implanted pump unit 50 may include a microprocessor 91, transceiver 92, and/or battery 93 built into the unit. The microprocessor 91 may be used to process instructions or any other kind of information sent to pump unit 50 by the external controller 89 or received therefrom via the transceiver 92.
It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.

Claims

CLAIMSWhat is claimed is:
1. A spinal implant comprising: a first spinal attachment member (39, 47) for attaching to a first spinal element (37, 45); a second spinal attachment member (40, 48) for attaching to a second spinal portion (38, 46); and a post-implantation variable dimension device (70, 80) disposed between said first and second spinal attachment members (39, 47, 40, 48), which is operable after completing surgery in which said spinal implant was installed into a patient, to cause relative movement between said first and second spinal attachment members (39, 47, 40, 48); characterized in that said post-implantation variable dimension device (70, 80) comprises a fluid-operated piston (41, 49) in fluid communication with an implanted pump unit (42, 50) via a tube (43, 51), said implanted pump unit (42, 50) being remotely controlled by an external controller (89) external to the patient's body.
2. The spinal implant according to claim 1, wherein said first and second spinal attachment members (39, 47, 40, 48) comprise pedicle screws.
3. The spinal implant according to claim 1, wherein said attachment members (39, 40) have a curved cross-sectional shape.
4. The spinal implant according to claim 1, wherein said attachment members (47, 48) each comprise a first portion, which contacts said spinal elements (45, 46), from which extends a second portion, not located between said spinal elements (45, 46), upon which said piston (49) acts to vary a distance between said spinal elements (45, 46).
5. The spinal implant according to claim 1, wherein said piston (41) is located between the spinal elements (37, 38).
6. The spinal implant according to claim 1, wherein said pump (49) is not located between the spinal elements (45, 46).
7. The spinal implant according to claim 1, wherein said pump unit (50) and said piston (49) straddle outer portions of the spinal elements (45, 46).
8. The spinal implant according to claim 1, wherein said implanted pump unit (42, 50) comprises a microprocessor (91) therein.
9. The spinal implant according to claim 1, wherein said implanted pump unit (42, 50) comprises a transceiver (92) therein.
10. The spinal implant according to claim 1, wherein said implanted pump unit (42, 50) comprises a battery (93) therein.
11. A spinal implant comprising: a first spinal attachment member (47) for attaching to a first spinal element (45); a second spinal attachment member (48) for attaching to a second spinal portion (46); and a post-implantation variable dimension device (80) disposed between said first and second spinal attachment members (47, 48), which is operable after completing surgery in which said spinal implant was installed into a patient, to cause relative movement between said first and second spinal attachment members (47, 48); characterized in that said post-implantation variable dimension device (80) comprises a fluid-operated piston (49) in fluid communication with an implanted pump unit (50) via a tube (51), said implanted pump unit (50) being remotely controlled by an external controller (89) external to the patient's body, and wherein said piston (49) is not located between the spinal elements (45, 46), and wherein said attachment members (47, 48) each comprise a first portion (81), which contacts the spinal elements (45, 46), from which extends a second portion (82) not located between the spinal elements (45, 46) upon which said piston (49) acts to vary a distance between the spinal elements (45, 46).
12. The spinal implant according to claim 11, wherein said pump unit (50) and said piston (49) straddle outer portions of the spinal elements (45, 46).
PCT/US2010/036804 2009-06-03 2010-06-01 Programmable fluid actuated spinal implant having a post-operative adjustable dimension WO2010141402A1 (en)

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