WO2018196821A1

WO2018196821A1 - Interbody fusion system with minimally invasive access approach

Info

Publication number: WO2018196821A1
Application number: PCT/CN2018/084659
Authority: WO
Inventors: 吕世文; 邓双; 毛克亚; 汪宇; 张鹏云
Original assignee: 宁波华科润生物科技有限公司
Priority date: 2017-04-28
Filing date: 2018-04-26
Publication date: 2018-11-01
Also published as: CN106983586B; CN106983586A

Abstract

Disclosed is an interbody fusion system with a minimally invasive access approach, comprising a pouch (1) and support material (11). The pouch (1) can fold or retract, one end of the pouch (1) is provided with an injection port (12), and the support material (11) is injected inside the pouch (1) via the injection port (12). When in a full state, the pouch (1) is an elongated structure, and a face of the pouch (1) in contact with upper and lower vertebrae is a vertebrae contact face. A retractable limiting mechanism (2) is provided on a side face of the pouch (1) in the lengthwise direction, and the width of the retractable limiting mechanism (2) is smaller than or equal to the width of the pouch (1) in a naturally full state. When the pouch (1) is implanted in an intervertebral disc and the support material (11) is injected, the cross section of the pouch (1) has an I-shape or a rectangular shape parallel to the widthwise direction and perpendicular to the vertebrae contact face. The invention solves the problem of not being able to control the contact area between a fusion device and upper and lower vertebrae, so the bone space is too small, affecting the fusion result of the upper and lower vertebrae; and the invention can achieve non-graded adaptation to the height of the intervertebral gap, and the contact area of the fusion device with the upper and lower vertebrae is controllable.

Description

Vertebral fusion system through minimally invasive access

Related application

The present application claims priority to Chinese Patent Application No. PCT Application No. No. No. No. No. No. No. No. No. .

Technical field

The present application relates to the field of spinal interbody fusion, and in particular to a vertebral body fusion system through a minimally invasive approach.

Background technique

Spinal degenerative diseases and structural damage are an important cause of pain, loss of sensory and motor function, and even loss of the neck, shoulders and legs. In the 1950s, Cloward first proposed posterior lumbar fusion (PLIF), which became one of the basic surgical procedures in today's spine surgery. In 1986, Badgy and Kuslich designed the Cage for the human body, the BAK system. Since then, the interbody fusion technique has been greatly developed, and it has become a basic surgical method for the treatment of spinal degenerative diseases and structural damage.

The principle of the interbody fusion cage is centered on the diseased intervertebral space. After the interbody fusion cage is implanted, the expansion force causes the muscle, the annulus and the anterior and posterior longitudinal ligaments of the fusion segment to be under continuous tension to make the fusion section. The segments and cages reach a three-dimensional superstatic fixed. Secondly, the interbody cage restores the stress and stability of the anterior and middle column of the spine by restoring the height of the intervertebral space, restores and maintains the natural bulge of the spine, enlarges the intervertebral foramen, and relieves the pressure of the dural sac and nerve root. The hollow structure of the interbody fusion cage provides a good mechanical environment for the fusion of the cancellous bone inside, thereby achieving the purpose of permanent fusion of the interface.

The conventional conventional cages generally have a fixed-shaped box structure, and are adapted to different vertebral body gaps by a series of different height models, and cannot completely match the intervertebral space of the patient; and the shape cannot be changed, and the wound is more implanted. Large, the damage to the patient is large, and the postoperative recovery is slow.

In view of the defects in the above product structure, some expandable fuse designs have emerged. For example, Chinese patent CN 105380735 A discloses an intervertebral filling fusion device for filling between any two adjacent vertebral body endplates of a human lumbar vertebra, by a receiving member and a receiving member. The peripheral mesh body is composed, and in use, a first filler having self-coagulability is filled between the container and the mesh body. However, there is no defining structure at the periphery of the mesh body, and when the first filling material is filled with the coagulating property, the shape of the expanded body of the mesh body is uncontrollable, and the contact area with the upper and lower vertebral bodies is uncontrollable, so that the bone grafting space is too small. It affects the fusion effect of the upper and lower vertebrae.

Summary of the invention

In view of the above-mentioned drawbacks of the prior art, the technical problem to be solved by the present application is to provide a vertebral body fusion system through a minimally invasive approach, which can achieve a level-free adaptation to the height of the intervertebral space and the upper and lower vertebrae. The contact area of the body is controllable.

The technical solution adopted by the present application to solve its technical problems is:

A vertebral body fusion system through a minimally invasive access approach, comprising a pouch and a support material, the pouch being foldable or contractible, an injection port being provided at one end of the pouch, the support material passing through the injection The mouth is injected into the interior of the pouch, and the pouch is in an elongated structure when the pouch is in a filled state, and the surface of the pouch that is in contact with the upper and lower vertebral bodies is a vertebral body contact surface, and the length of the side of the pouch is set. a contracting defining mechanism, the width of the contractible defining mechanism being less than or equal to a width of the pouch in a natural filling state, the pouch being implanted into the intervertebral disc and completing the injection of the support material The capsule is parallel to the width direction and perpendicular to the cross-section of the vertebral body contact surface in a "work" shape or a rectangle.

The purpose of the application can also be further achieved by the following technical solutions:

Preferably, the collapsible defining mechanism comprises two sheet-like structures and a connecting piece connecting the two sheet-like structures.

Preferably, the two sheet-like structures are made in one piece or in a separate combination with the connecting member.

Preferably, the connecting member is an arc structure, and both ends of the arc structure connect adjacent ends of the two sheet structures.

Preferably, the connector is a plurality of rods or wires, and a plurality of the rods or wires are disposed between the two sheet structures.

Preferably, the sheet structure is a mesh sheet which is engraved or woven.

Preferably, the pouch is provided with a through hole in a direction perpendicular to the contact surface of the vertebral body.

Preferably, the space defined by the through hole is a bone graft, and the bone graft is isolated from the inner space of the bag.

Preferably, the through hole has a plurality of through holes, and a plurality of the through holes have a communication passage therebetween.

Preferably, an anti-slip structure is provided on the vertebral body contact surface.

Preferably, the anti-slip structure is a mesh-shaped sheet, and the support material is forced to protrude from the lattice of the mesh-shaped sheet to form a non-slip protrusion.

Preferably, the anti-slip structure is a compressible sheet, and a barb or a protrusion is disposed on a surface of the compressible sheet in contact with the vertebral body.

Preferably, the anti-slip structure is a barb or protrusion fixed to the surface of the pouch.

Preferably, a check valve is provided on the injection port.

Preferably, the support material is a self-solidifying bone filler material.

Preferably, the vertebral body fusion system further includes an injection tube, the injection tube includes an inner tube and an outer tube, and the distal end of the outer tube is provided with an elastic bayonet, and the connector of the elastic bayonet and the injection port Snap-on connection.

Compared with the prior art, the advantages and progress of the present application are as follows:

1. The vertebral body fusion system of the minimally invasive access approach of the present application forms a cage by injecting a support material into a collapsible or contractible pouch, which can achieve a levelless elevation to accommodate different intervertebral spaces.

2. The vertebral body fusion system of the minimally invasive access approach of the present application is provided with a contractible defining mechanism on the side thereof, and is limited to a "work" shape or a rectangle on a cross section parallel to the width direction and perpendicular to the contact surface of the vertebral body. On the one hand, the size of the contact surface of the vertebral body fusion system and the vertebral body is controlled, and on the other hand, the space of the bone graft is left as large as possible when the vertebral body contact surface is the same size.

3. The vertebral body fusion system of the minimally invasive access approach of the present application consists of a collapsible or collapsible pouch and a collapsible defining mechanism, which is also compressible as a whole, can enter the intervertebral space through a minimally invasive passage, and then The expansion of the intervertebral space makes the patient's trauma less during surgery, which is conducive to postoperative recovery.

4. The vertebral body fusion system of the minimally invasive access method of the present application, wherein one or more through holes are arranged in a direction perpendicular to the contact surface of the vertebral body, and the space defined by the through hole is a bone graft. The silo, multiple bone grafts facilitate the subsequent injection of bone active substances.

5. The vertebral body fusion system of the minimally invasive approach of the present application, which provides an anti-slip structure on the vertebral body contact surface, can effectively prevent the vertebral body fusion system from moving after being implanted in the body.

6. The injection tube of the vertebral body fusion system of the minimally invasive access method of the present application comprises an inner tube and an outer tube, and the distal end of the outer tube is provided with a snap-fit connection between the elastic bayonet and the injection port, which can be avoided. Mis-rotation caused by the threaded connection causes the detachment to affect the operation, and the thread of the filler tube can be made thinner by replacing the thread with the design of the elastic bayonet.

7. The injection port of the vertebral body fusion system of the minimally invasive access approach of the present application is provided with a check valve to prevent leakage of the support material filled into the bag.

DRAWINGS

1A is a schematic view showing a cross-section of a vertebral body fusion system through a minimally invasive access approach in a direction parallel to the width direction and perpendicular to the contact surface of the vertebral body;

1B is a schematic view showing a rectangular cross section of a vertebral body fusion system through a minimally invasive access approach in a direction parallel to the width direction and perpendicular to the contact surface of the vertebral body;

2A is a schematic structural view of a first contractible defining mechanism;

2B is a schematic structural view of a second contractible defining mechanism;

Figure 2C is a cross-sectional view of the third contractible defining mechanism in the height direction;

3A is a schematic structural view of a first through hole;

3B is a schematic structural view of a second through hole;

3C is a schematic structural view of a third through hole;

4A is a schematic view showing the structure of a first bone active substance transporting method of a vertebral body fusion system;

4B is a schematic structural view of a second bone active substance transporting method of a vertebral body fusion system;

Figure 5A is a schematic structural view of a syringe of a vertebral body fusion system;

Figure 5B is a partial enlarged view of the distal end of the outer tube of the injection tube of the vertebral body fusion system;

6A is a schematic structural view of a non-slip structure of a mesh-shaped sheet;

6B is a schematic structural view of a non-slip structure as a compressible sheet;

Among them, 1 is the pouch, 2 is the contraction restricting mechanism, 3 is the injection tube, 11 is the support material, 12 is the injection port, 13 is the anti-slip structure, 14 is the connector, 15 is the bone graft, 16 is the first The through hole, 17 is a second through hole, 21 is a sheet-like structure, 22 is a connecting member, 23 is a non-ductile flexible wire or wire, 31 is an inner tube, 32 is an outer tube, and 321 is a flexible bayonet.

detailed description

In order to make the objects, technical solutions, and advantages of the present application more comprehensible, the present application will be described in detail below with reference to the accompanying drawings.

As shown in FIGS. 1A and 1B, a vertebral body fusion system via a minimally invasive access approach includes a pouch 1 and a support material that can be folded or contracted at one end of the pouch 1 An injection port 12 is provided, and the support material is injected into the inside of the pouch 1 through the injection port 12, and the pouch 1 has an elongated structure in a filled state, and the pouch 1 is in contact with the upper and lower vertebral bodies. For the vertebral body contact surface, a contractible defining mechanism 2 is disposed in the longitudinal direction of the side surface of the pouch 1, as shown in FIG. 1A, when the width of the retractable defining mechanism 2 is smaller than the natural filling state of the pouch 1 When the pouch 1 is implanted in the intervertebral disc and the injection of the supporting material is completed, the pouch 1 is parallel to the width direction and perpendicular to the cross section of the vertebral body contact surface in a "work" shape; As shown, when the pouch 1 is designed in the shape of a square strip having a square cross section, and the width of the collapsible defining mechanism 2 is equal to the width of the pouch 1 in a state of natural filling, the pouch 1 is implanted in the intervertebral disc and After the injection of the support material is completed, the pouch 1 is parallel to the width direction and perpendicular to the vertebra Rectangular in cross section of the contact surface.

The pouch 1 may be woven from an implantable wire, such as a woven capsule of a PET wire; or a film capsule made of an implantable material, such as a film capsule sintered from PTFE. . By injecting the support material into the pouch 1, the vertebral body fusion system can be made to adapt to different vertebral body gaps without level.

As shown in Figure 2C, the support material 11 is a self-solidifying bone filler material, such as bone cement. The support material 11 is in a fluid state at the time of injection, and the support material 11 is injected into the interior of the pouch 1 to a desired elongated structure, and the support material 11 solidifies itself in a short time, thereby Provides stable support between the upper and lower vertebral bodies.

In an embodiment, the collapsible defining mechanism 2 comprises two sheet-like structures 21 and a connecting piece 22 connecting the two sheet-like structures 21, and the sheet-like structure 21 and the connecting piece 22 can They can also be made by a combination of welding or bonding.

The connecting member 22 limits the width of the collapsible defining mechanism 2, and when the width of the collapsible defining mechanism 2 is smaller than the width of the bag 1 in a natural filling state, the pouch 1 is implanted in the intervertebral disc and the supporting material is completed. After the injection of 11 , the cross section of the pouch 1 parallel to the width direction and perpendicular to the contact surface of the vertebral body has a “work” shape as shown in FIG. 1A , so that the shape and size of the contact surface with the vertebral body are effectively controlled. Moreover, in the case of the same vertebral body contact surface, more bone graft volume can be obtained due to the inward depression of the side of the "work" shape structure.

As shown in FIG. 2A, the sheet structure 21 is a meshed sheet which is engraved or woven, and is made of an elastic material; the connecting member 22 has an arc structure, and the two ends are connected to the two sheet structures. The adjacent end of 21 becomes the complete defining mechanism 2 and can be compressed as a whole. The sheet-like structure 21 is fixed on the left and right opposite faces of the pouch 1 by means of bonding or stitching. This connection avoids complicated mechanical fastening, so that the overall size of the fusion system after compression is small.

As shown in FIG. 2B, the connecting member 22 may also be a plurality of rods or wires, and a plurality of rods or wires are disposed between the two sheet-like structures 21, for example, a plurality of rods or ends of the wires are respectively connected. The intermediate portion of the two sheet-like structures 21 forms a complete collapsible defining mechanism 2 that limits the filling shape of the pouch.

In another embodiment, as shown in FIG. 2C, the contractible defining mechanism 2 is a plurality of non-ductile flexible wires or wires 23, and the two ends are respectively connected to the left and right opposite faces of the bag 1, and The unfolded length is less than or equal to the width of the pouch 1 . The width of the left and right opposite faces of the pouch 1 is limited by a plurality of the non-ductile flexible threads or wires 23, and the pouch 1 is parallel to the width direction and perpendicular after being restrained by the upper and lower vertebral bodies. The cross section of the vertebral body contact surface is "work" or rectangular, so that the shape of the contact surface with the vertebral body is effectively controlled.

The bag 1 is further provided with a through hole in a direction perpendicular to the contact surface of the vertebral body. When the bag 1 is in a natural filling state, the through hole extends to the upper and lower vertebral body contact surface, and the space defined by the through hole The bone graft chamber 15 is isolated from the filling space inside the pouch 1 and can inject bone active material into the bone graft chamber 15 to fuse the upper and lower vertebral bodies. The through holes may be square (as shown in FIG. 3A) or circular (as shown in FIG. 3B). As shown in FIG. 3C, the through holes may be plural, and a plurality of the through holes have communication passages therebetween. Multiple bone grafts facilitate subsequent injection of bone active material.

As shown in FIG. 4A, a first through hole 16 communicating with the bone graft 15 is provided on the side of the pouch 1, and the injection port 12 is disposed beside the first through hole 16 when passing through the injection tube 3 to the pouch After the support material 11 is injected in 1 , a filling tube can be inserted into the first through hole 16 to fill the bone active material to complete the implantation of the entire vertebral body fusion system.

As shown in FIG. 4B, a second through hole 17 communicating with the bone graft chamber 15 is disposed on the side of the bag 1, and the injection port 12 is disposed on the circumferential surface of the through hole forming the bone graft, and is connected to the second pass. The hole 17 is coaxial, so that the injection tube 3 for injecting the support material 11 and the filling tube filled with the bone active material can be put together when pre-installed. In use, after the support material 11 is injected, the injection tube 3 can be pulled out to fill the bone activity. Substance, simple and consistent operation.

In one embodiment, a check valve is provided on the injection port 12 to prevent leakage of the support material filled into the bag. The check valve is a one-way valve.

As shown in FIGS. 5A and 5B, a connector 14 is provided at the injection port 12, and the connector 14 forms a detachable connection with the syringe 3. The detachable connection may be a threaded connection or a snap-on connection. As shown in FIG. 5A, the injection tube 3 includes an inner tube 31 that fits over the inner tube 31 and moves axially relative to the inner tube 31, and an outer tube 32 that is axially movable. The distal end of the inner tube 31 is snap-connected with the connecting head 14 through the elastic bayonet 321 . When the inner tube 31 protrudes from the elastic bayonet 321 , the elastic bayonet 321 is forcefully opened to adaptively cooperate with the connector 14 to achieve a fixed connection. As shown in Fig. 5B, when the inner tube 31 is retracted from the elastic tab 321 , the elastic tab 321 is unstressed and closed, and is automatically detached from the connector 14 so that the syringe 3 can be completely detached. The distal end of the outer tube 32 is provided with a snap-fit connection of the elastic bayonet 321 and the connector 14 of the injection port 12, which can avoid the mis-rotation caused by the screw connection and cause the disengagement operation, and can replace the thread by the design of the elastic bayonet to make the injection The overall wall of the tube 3 is thinner.

In order to prevent the vertebral body fusion system from moving after being implanted in the body, an anti-slip structure 13 is disposed on the vertebral body contact surface of the pouch 1, as shown in FIGS. 6A and 6B, the anti-slip structure 13 is fixed to the surface of the pouch. Barbs or protrusions, which are fitted to the upper and lower vertebral surfaces to prevent displacement of the vertebral body fusion system; as shown in FIG. 6A, the anti-slip structure 13 may also be a mesh-shaped sheet, when the bag 1 is filled The support material 11 is forced to protrude from the lattice of the mesh-shaped sheet to form a non-slip protrusion; as shown in FIG. 6B, the anti-slip structure 13 is a compressible sheet disposed on the outer side of the bag 1 A barb or a projection is provided on a surface of the compressible sheet that is in contact with the vertebral body.

It should be noted that the above description is only a preferred embodiment of the present application, and is not intended to limit the application, and any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application are It should be included in the scope of protection of this application.

Claims

A vertebral body fusion system via a minimally invasive access approach, comprising a pouch (1) and a support material (11), the pouch (1) being foldable or contractible, in the pouch ( An injection port (12) is provided at one end of 1), and the support material (11) is injected into the inside of the bag (1) through the injection port (12), and the bag (1) is in a long state when filled. a structure in which the surface of the pouch (1) in contact with the upper and lower vertebral bodies is a vertebral body contact surface, and a contractible defining mechanism (2) is disposed in a longitudinal direction of a side surface of the pouch (1), the contractible The width of the defining mechanism (2) is less than or equal to the width of the pouch (1) in a natural filling state, when the pouch (1) is implanted in the intervertebral disc and the injection of the supporting material (11) is completed, The pouch (1) is parallel to the width direction and perpendicular to the cross section of the vertebral body contact surface in a "work" shape or a rectangle.
A minimally invasive access vertebral fusion system according to claim 1 wherein said contractile defining mechanism (2) comprises two sheet-like structures (21) and connects said two sheets Connector (22) of structure (21).
The vertebral body fusion system according to claim 2, wherein the two sheet structures (21) are integrally formed with the connecting member (22) or are separately combined to make.
The vertebral body fusion system according to claim 2, wherein the connecting member (22) is an arcuate structure, and the two ends of the curved structure connect two of the sheets Adjacent ends of structure (21).
The vertebral body fusion system according to claim 2, wherein the connecting member (22) is a plurality of rods or wires, and the plurality of rods or wires are disposed in two places. Between the sheet structures (21).
The vertebral body fusion system according to claim 2, wherein the sheet structure (21) is a mesh sheet which is engraved or woven.
The vertebral body fusion system according to claim 1, wherein the pouch (1) is provided with a through hole in a direction perpendicular to the vertebral body contact surface.
The vertebral body fusion system according to claim 7, wherein the space defined by the through hole is a bone graft (15), and the bone graft (15) and the bag The internal space of the capsule (1) is isolated.
The vertebral body fusion system of the minimally invasive access method according to claim 7, wherein the plurality of through holes have a plurality of communication passages between the plurality of through holes.
The vertebral body fusion system according to claim 1, wherein an anti-slip structure (13) is provided on the vertebral body contact surface.
The vertebral body fusion system according to claim 10, wherein the anti-slip structure (13) is a mesh-shaped sheet, and the support material (11) is forced from the net The lattice of the lattice sheet is convexly formed to form a non-slip projection.
The vertebral body fusion system of the minimally invasive access approach of claim 10, wherein the anti-slip structure (13) is a compressible sheet on a face where the compressible sheet contacts the vertebral body Set barbs or bumps.
A minimally invasive access vertebral body fusion system according to claim 10, wherein said anti-slip structure (13) is a barb or projection fixed to the surface of said pouch (1).
The vertebral body fusion system of the minimally invasive access approach of claim 1, wherein a check valve is provided on the injection port (12).
The vertebral body fusion system according to any one of claims 1 to 14, wherein the support material (11) is a self-solidified bone filling material.