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Patent Searching and Data


Title:
EXPANDABLE POLYAXIAL SPINAL SYSTEM
Document Type and Number:
WIPO Patent Application WO/2020/260940
Kind Code:
A1
Abstract:
A spinal pedicle screw system includes distractions rods and has the ability to be distracted after the screws are inserted into the pedicle and maintain polyaxial motion via poly axial joints.

Inventors:
ARNIN URI (IL)
Application Number:
IB2020/000423
Publication Date:
December 30, 2020
Filing Date:
June 03, 2020
Export Citation:
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Assignee:
APIFIX LTD (IL)
International Classes:
A61B17/56; A61B17/58; A61B17/68; A61B17/70; A61B17/86; A61B17/88
Foreign References:
US9517089B12016-12-13
US20180125533A12018-05-10
US8926669B22015-01-06
US20190059950A12019-02-28
US7611526B22009-11-03
US9023087B22015-05-05
US20050228382A12005-10-13
Attorney, Agent or Firm:
ALKALAY, Yoav et al. (IL)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1. A spinal system comprising:

a first distraction rod which has a first connector mounted at an end thereof; and a second distraction rod which has a second connector mounted at an end thereof, both of said rods being arranged to move in a housing, and wherein each of said connectors is mounted on a poly axial joint and secured by a fastener, each of said poly axial joints being attached to a pedicle screw, and wherein said fastener is tightened against a portion of said poly axial joint but does not inhibit poly axial movement of said poly axial joint, such that even after tightening said fastener, said connectors cannot move off said poly axial joints but said poly axial joints are free to move poly axially at all times; and

an extender member coupled to a connecting element which is coupled to said polyaxial joint of said second distraction rod by an extender member fastener, wherein said extender member fastener is tightened against a portion of said polyaxial joint of said second distraction rod but does not inhibit polyaxial movement of said polyaxial joint of said second distraction rod, such that there is free polyaxial movement between said extender member and said second distraction rod.

2. The spinal system according to claim 1, wherein said extender member is collinear with said second distraction rod.

3. The spinal system according to claim 1, wherein said extender member is not collinear with said second distraction rod.

4. The spinal system according to claim 1, wherein at least one of said first and second distraction rods is affixed by a distraction fastener at any desired location along said housing.

5. The spinal system according to claim 4, wherein at least one of said first and second distraction rods is rotated about its longitudinal axis before being locked in place by said distraction fastener.

6. The spinal system according to claim 1, wherein at least one of said distraction rods is at least partially threaded and mates with an internal thread in said housing.

7. The spinal system according to claim 1, wherein both of said distraction rods are at least partially threaded and mate with an internal thread in said housing, and wherein threads of one of said distraction rods are right-handed and threads of the other distraction rod are left-handed.

8. The spinal system according to claim 1 , wherein said housing comprises a fluid inlet for introducing therethrough fluid.

9. The spinal system according to claim 1, wherein said housing comprises a biasing device operative to apply a biasing force on at least one of said first and second distraction rods.

10. A spinal system comprising:

a first distraction rod which has a first connector mounted at an end thereof; and a second distraction rod which has a second connector mounted at an end thereof, both of said rods being arranged to move in a housing, and wherein each of said connectors is mounted on a poly axial joint and secured by a fastener, each of said poly axial joints being part of a pedicle screw, and wherein said fastener is tightened against a portion of said poly axial joint but does not inhibit poly axial movement of said poly axial joint, such that even after tightening said fastener, said connectors cannot move off said poly axial joints but said poly axial joints are free to move poly axially at all times; and

an extender member coupled to a connecting element which is coupled to said polyaxial joint of said second distraction rod by an extender member fastener, wherein said extender member fastener is tightened against a portion of said polyaxial joint of said second distraction rod but does not inhibit polyaxial movement of said polyaxial joint of said second distraction rod, such that there is free polyaxial movement between said extender member and said second distraction rod.

11. The spinal system according to claim 10, wherein said extender member is collinear with said second distraction rod.

12. The spinal system according to claim 10, wherein said extender member is not collinear with said second distraction rod.

13. The spinal system according to claim 10, wherein at least one of said first and second distraction rods is affixed by a distraction fastener at any desired location along said housing.

14. The spinal system according to claim 13, wherein at least one of said first and second distraction rods is rotated about its longitudinal axis before being locked in place by said distraction fastener.

15. The spinal system according to claim 10, wherein at least one of said distraction rods is at least partially threaded and mates with an internal thread in said housing.

16. The spinal system according to claim 10, wherein both of said distraction rods are at least partially threaded and mate with an internal thread in said housing, and wherein threads of one of said distraction rods are right-handed and threads of the other distraction rod are left-handed.

17. The spinal system according to claim 10, wherein said housing comprises a fluid inlet for introducing therethrough fluid.

18. The spinal system according to claim 10, wherein said housing comprises a biasing device operative to apply a biasing force on at least one of said first and second distraction rods.

Description:
EXPANDABLE POLY AXIAL SPINAL SYSTEM

FIELD OF THE INVENTION

The present invention relates generally to spinal implants and prostheses, and particularly to a spinal pedicle screws based system designed to be expandable and maintain polyaxial motion in situ.

BACKGROUND OF THE INVENTION

Spine scoliosis is affecting significant portion of the population. Current surgical treatment involves many times the use of an intervertebral pedicle screws based systems designed to be placed between two or more vertebrae.

The use of standard pedicle screws system is typically associated with spinal fusion, which has some known negative impacts. It is of value therefor to have a non-fusion system that can prevent or correct scoliosis of some patients.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved spinal pedicle screws based system that can be expanded after the screws are inserted to the pedicles of the two vertebrae and maintain spinal motion via one or more polyaxial joints.

There is thus provided in accordance with anon-limiting embodiment of the present invention a spinal system including a first distraction rod which has a first connector mounted at an end thereof, and a second distraction rod which has a second connector mounted at an end thereof, both of the rods being arranged to move in a housing, and wherein each of the connectors is mounted on a polyaxial joint and secured by a fastener, each of the polyaxial joints being attached to, or part of, a pedicle screw, and wherein the fastener is tightened against a portion of the polyaxial joint but does not inhibit polyaxial movement of the polyaxial j oint, such that even after tightening the fastener, the connectors cannot move off the polyaxial joints but the polyaxial joints are free to move polyaxially at all times.

In accordance with an embodiment of the present invention at least one of the first and second distraction rods is affixed by a distraction fastener at any desired location along the housing.

In accordance with an embodiment of the present invention at least one of the first and second distraction rods is rotated about its longitudinal axis before being locked in place by the distraction fastener. In accordance with an embodiment of the present invention at least one of the distraction rods is at least partially threaded and mates with an internal thread in the housing.

In accordance with an embodiment of the present invention both of the distraction rods are at least partially threaded and mate with an internal thread in the housing, and wherein threads of one of the distraction rods are right-handed and threads of the other distraction rod are left-handed.

In accordance with an embodiment of the present invention the housing includes a fluid inlet for introducing therethrough fluid.

In accordance with an embodiment of the present invention the housing includes a biasing device operative to apply a biasing force on at least one of the first and second distraction rods.

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 system, in an initial contracted configuration before distraction, constructed and operative in accordance with a non- limiting embodiment of the invention;

Fig. 2 is a simplified pictorial illustration of the spinal system in an expanded/distracted configuration;

Fig. 3 is a simplified, cutaway illustration of the system in its expanded/distracted configuration;

Fig. 4 is a simplified pictorial illustration of a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, wherein distraction is done using threaded elements;

Fig. 4A is a simplified pictorial illustration of a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, including an extender member which may be fixedly or pivotally attached to the spinal system;

Fig. 5 is a simplified pictorial illustration of a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, wherein distraction is done using hydraulic or pneumatic force; and

Fig. 6 is a simplified pictorial illustration of a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, wherein distraction is done using a biasing device. DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to Figs. 1-3, which illustrate a spinal system 100, constructed and operative in accordance with a non-limiting embodiment of the invention.

The spinal system 10 includes a first distraction rod 12 which has a first connector 14 mounted at an end thereof, and a second distraction rod 16 which has a second connector 18 mounted at an end thereof. Both rods 12 and 16 are arranged to move (e.g., translate or slide) in a housing 20. Both connectors 14 and 18 may each include a ring mounted on a poly axial joint 22 (which may be, without limitation, a spherically shaped head) and secured by a fastener 24, such as a nut. The poly axial joint 22 may be attached to, or may be part of, a pedicle screw 26. The fastener 24 is tightened against a portion (in the illustration, the upper portion) of the poly axial joint 22 but does not inhibit poly axial movement of the poly axial joint. Thus, even after tightening the fastener 24, the connector 14 or 18 cannot move off the polyaxial joint but the polyaxial joint is free to move polyaxially at all times.

Distraction fasteners 28 and 30 may fasten the first and second distraction rods 12 and 16, respectively, at any desired location along housing 20.

After inserting the pedicle screws 26 into the patient’s vertebrae it is possible to distract or expand (the terms being used interchangeably) the distance between the screws by using a distractor (not shown) or any other suitable means. The distracted orientation is shown in Fig. 2. After distraction the distraction fasteners 28 and 30 can be used to fix the distance between the pedicle screws.

As seen in Figs. 1 and 2, the first and second distraction rods 12 and 16 may be rotated about their respective longitudinal axes before being locked in place by distraction fasteners 28 and 30. For example, only one of the distraction rods may be rotated while the other is not rotated, or both may be rotated. As another example, only one of the distraction rods may be distracted while the other is not distracted, or both may be distracted. Whichever rods is not distracted may be locked in place by the distraction fastener, or alternatively, may be left unlocked, in which case that rod is free to move in translation and in rotation.

Reference is now made to Fig. 4, which illustrates a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, with like elements being designated by like numerals. In this embodiment, distraction rods 42 and 44 are at least partially threaded and mate with an internal thread 46 in housing 20. Distraction may be done by rotating the rods with respect to the housing, that is, by rotating the rods with the housing stationary or by rotating the housing with the rods not rotating, or by rotating both the rods and the housing. In one embodiment, threads 43 of rod 42 are right-hand threads whereas threads 45 of rod 44 are left-hand threads. In this manner, rotating the housing in one direction causes the rods 42 and 44 to move simultaneously in opposite directions. After distraction to the desired distance between the pedicle screws, distraction fasteners (not shown) may be used to fix the system at the desired position.

Reference is now made to Fig. 4A, which illustrates another version of the spinal system of Fig. 4. It is noted that the embodiment of Fig. 4A can also be implemented with any of the other embodiments and is not limited to distraction rods that are in threaded engagement with the housing.

In the version of Fig. 4A, an extender member 70 is a rod coupled to a connecting element 72, which may be U-shaped. Connecting element 72 may be coupled to the poly axial joint 22 of the distraction rod 44 by a fastener 74, such as a screw. As described above for fastener 24, here too, fastener 74 is tightened against a portion of the polyaxial joint 22 but does not inhibit polyaxial movement of the polyaxial joint 22. Thus, even after tightening the fastener 74, the extender member 70 cannot move off the polyaxial joint 22 but the polyaxial joint 22 is free to move poly axially at all times. Thus, there is free polyaxial movement between the extender member 70 and distraction rod 44.

The extender member 70 may be secured to spinal structure with one or two pedicle screws 76. The extender member 70 may be collinear with rod 44 or may be tilted with respect to rod 44.

Reference is now made to Fig. 5, which illustrates a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, with like elements being designated by like numerals. In this embodiment, distraction is done using hydraulic or pneumatic force. For example, housing 20 may be provided with a fluid inlet 52 for introducing therethrough fluid (e.g., water, saline, air, etc.). The fluid pressure acts on rods 12 and 16 and increase the distance between them. Sealing rings (not shown) may be provided to seal the fluid in the housing 20. The fluid may be introduced at any point during or after the surgical procedure.

In one embodiment, one of the rods can be affixed to the housing while the other rod is distracted by the fluid (hydraulic or pneumatic) force.

Reference is now made to Fig. 6, which illustrates a spinal system, constructed and operative in accordance with another non-limiting embodiment of the invention, with like elements being designated by like numerals. In this embodiment, distraction is done using a biasing device 62 disposed in the housing, such as a coil spring or flexible band. Biasing device 62 may be made of metal or elastomeric materials. Biasing device 62 may apply a constant or variable spring force on the rods 12 and 16.

In one embodiment, one of the rods can be affixed to the housing while the other rod is distracted by the spring force.