CN107049564B

CN107049564B - Centrum fusion device that passes through path access of wicresoft

Info

Publication number: CN107049564B
Application number: CN201710298505.4A
Authority: CN
Inventors: 吕世文; 邓双; 毛克亚; 汪宇; 张鹏云
Original assignee: NINGBO HUAKERUN BIOTECHNOLOGY CO Ltd
Current assignee: NINGBO HUAKERUN BIOTECHNOLOGY CO Ltd
Priority date: 2017-04-28
Filing date: 2017-04-28
Publication date: 2020-02-07
Anticipated expiration: 2037-04-28
Also published as: CN107049564A; WO2018196820A1

Abstract

The invention relates to a vertebral body fusion device accessed through a minimally invasive access, which comprises a bag and a supporting material, wherein the bag can be folded or contracted, an injection port is arranged at one end of the bag, the supporting material is injected into the bag through the injection port, the surfaces of the bag, which are contacted with an upper vertebral body and a lower vertebral body, are vertebral body contact surfaces, a limiting mechanism with a preset shape is arranged on the vertebral body contact surface, and when the bag is implanted into an intervertebral disc and the injection of the supporting material is completed, the vertebral body contact surface of the bag is in the preset shape; the problem that the fusion effect of the upper vertebral body and the lower vertebral body is influenced due to the fact that the bone grafting space is too small because the contact area of the fusion cage and the upper vertebral body and the lower vertebral body cannot be controlled is solved; can realize stepless adaptation to the height of the intervertebral space and the controllable contact area with the upper and lower vertebral bodies.

Description

Centrum fusion device that passes through path access of wicresoft

Technical Field

The invention relates to the field of spinal interbody fusion, in particular to a vertebral body fusion device accessed through a minimally invasive access.

Background

Degenerative spinal diseases and structural damage are important causes of pain in the neck, shoulders, waist and legs, and impaired or even lost sensory and motor functions. In the last 50 s, Cloward first proposed posterior lumbar fusion (PLIF), a technique developed as one of the basic surgical procedures for spinal surgery today. Badgy and Kuslich designed an interbody fusion Cage (Cage) suitable for use in humans in 1986, the BAK system. Since then, the interbody bone-grafting fusion technology has been greatly developed, and becomes a basic operation mode for treating spinal degenerative diseases and structural injuries.

The principle of the interbody fusion cage is that after the interbody fusion cage is implanted, the muscle, the fibrous ring and the anterior and posterior longitudinal ligaments of the fusion segment are in a continuous tension state by the distraction force, so that the fusion segment and the fusion cage achieve three-dimensional super-static fixation. And secondly, the intervertebral fusion cage recovers the stress and the stability of the front and middle columns of the spine, recovers and maintains the inherent physiological bulge of the spine, enlarges intervertebral foramen and relieves the pressure of the dural sac and nerve roots by recovering the height of the intervertebral space. The hollow structure of the intervertebral fusion cage provides a good mechanical environment for the fusion of the cancellous bone therein, thereby achieving the purpose of interface permanent fusion.

The existing conventional fusion cage is generally of a box-type structure with a fixed shape, adapts to different vertebral body gaps by depending on a series of models with different heights and cannot be completely matched with the vertebral body gaps of patients; but also can not change the shape, has larger wound when being implanted, has larger damage to patients and slow postoperative recovery.

In response to the above-mentioned deficiencies of product construction, some designs of inflatable cages have emerged. For example, chinese patent CN 105380735 a discloses an intervertebral filling fusion device for filling between any two adjacent vertebral endplates of a human lumbar vertebra, which comprises a receiving member and a mesh body disposed at the periphery of the receiving member, and when in use, a first filler with self-solidifying property is filled between the receiving member and the mesh body. However, no limiting structure is arranged on the periphery of the mesh body, and when the self-solidifying first filler is filled, the expanded shape of the mesh body is uncontrollable, so that the contact area with the upper vertebral body and the lower vertebral body cannot be controlled, and the bone grafting space is too small to influence the fusion effect of the upper vertebral body and the lower vertebral body.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, the present invention provides a vertebral body fusion device capable of achieving stepless adaptation to the height of the intervertebral space and access via minimally invasive approach with controllable contact area with the upper and lower vertebral bodies.

The technical scheme adopted by the invention for solving the technical problems is as follows:

a vertebral body fusion device entering a way through a minimally invasive access comprises a bag and a supporting material, wherein the bag can be folded or contracted, an injection port is formed in one end of the bag, the supporting material is injected into the bag through the injection port, the surfaces of the bag, which are in contact with an upper vertebral body and a lower vertebral body, are vertebral body contact surfaces, a limiting mechanism in a preset shape is arranged on the vertebral body contact surface, and when the bag is implanted into an intervertebral disc and the supporting material is injected, the vertebral body contact surface of the bag is in the preset shape.

The purpose of the invention can be further realized by the following technical scheme:

preferably, the restraining mechanism is a retractable structure.

Preferably, the restricting means is a mesh sheet material engraved or woven or an annular frame made of an elastic material.

Preferably, the restricting mechanism is a foldable structure formed by connecting a plurality of sheets to each other and taking a preset shape after being unfolded.

Preferably, the vertebral body fusion device further comprises a collapsible secondary containment structure disposed on a side of the pouch having a width less than or equal to the width of the pouch in its natural filling state.

Preferably, the secondary confinement structure comprises two sheet structures and a connector connecting the two sheet structures.

Preferably, the two sheet structures and the connecting piece are integrally manufactured or are manufactured in a split combination mode.

Preferably, the connecting piece is an arc-shaped structure, and two ends of the arc-shaped structure are connected with the adjacent end parts of the two sheet-shaped structures.

Preferably, the connector is a plurality of rods or wires, the plurality of rods or wires being disposed between two of the sheet-like structures.

Preferably, the sheet-like structure is a mesh sheet that is engraved or woven.

Preferably, the auxiliary limiting structure and the limiting mechanism are made into a cage-shaped structure integrally or separately.

Preferably, the pocket is provided with a through hole in a direction perpendicular to the vertebral body contacting surface.

Preferably, the space defined by the through hole is a bone graft compartment, which is isolated from the inner space of the pouch.

Preferably, there are a plurality of the through-holes, and a communication passage is provided between the plurality of the through-holes.

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 protrudes from the lattices of the mesh-shaped sheet under a force to form anti-slip projections.

Preferably, the anti-slip structure is a compressible sheet, and barbs or protrusions are arranged on the surface of the compressible sheet, which is in contact with the vertebral body.

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

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

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

Compared with the prior art, the invention has the following advantages and progresses:

1. the vertebral body fusion device entering the way through the minimally invasive access forms a fusion cage in a mode of injecting supporting materials into the foldable or contractible bag, and can realize stepless rise so as to adapt to different intervertebral spaces.

2. The limiting mechanism is arranged on the vertebral body contact surface of the vertebral body fusion device entering the path through the minimally invasive access and contacting with the upper vertebral body and the lower vertebral body, so that the vertebral body contact surface is limited to be in a preset shape, and the size of the contact surface of the system and the vertebral bodies is controlled.

3. The side surface of the vertebral body fusion device entering the way through the minimally invasive access is provided with the auxiliary limiting structure, so that the side surface of the bag is prevented from being arbitrarily bulged, the bone grafting volume is ensured not to be excessively occupied by the supporting material, and the fusion of the vertebral bodies is facilitated.

4. The vertebral body fusion device accessed through the minimally invasive access can reduce the volume in a compression or folding mode, enter the intervertebral space through the minimally invasive channel and expand in the intervertebral space, so that the wound of a patient is smaller during operation, and postoperative recovery is facilitated.

5. According to the vertebral body fusion device accessed through the minimally invasive access, 1 or more through holes are formed in the bag in the direction perpendicular to the contact surface of the vertebral body, the space defined by the through holes is a bone grafting bin, and the plurality of bone grafting bins are beneficial to injection of subsequent bone active substances.

6. The anti-slip structure is arranged on the surface of the bag, which is contacted with the upper and lower vertebral bodies, so that the vertebral body fusion device can be effectively prevented from moving after being implanted into a body.

7. The injection tube of the minimally invasive access vertebral body fusion device comprises an inner tube and an outer tube, wherein the far end of the outer tube is provided with an elastic bayonet which is connected with a connector of an injection port in a buckling mode, so that the phenomenon that the operation is influenced due to separation caused by mistaken rotation caused by threaded connection can be avoided, and the wall thickness of a filler conveying tube can be thinner by replacing threads through the design of the elastic bayonet.

8. The injection port of the minimally invasive access vertebral body fusion device is provided with the check valve, so that the supporting material filled in the bag can be prevented from leaking.

Drawings

FIG. 1 is a schematic view of a vertebral body fusion device accessed via a minimally invasive approach;

FIG. 2a is a schematic structural view of a first limiting mechanism;

FIG. 2b is a schematic structural view of a second limiting mechanism;

FIG. 2c is a schematic structural view of a third limiting mechanism;

FIG. 3 is a schematic structural view of the restraining mechanism in a collapsible configuration;

FIG. 4a is a schematic structural view of a first secondary confinement structure;

FIG. 4b is a schematic structural view of a second secondary confinement structure;

FIG. 4c is a sectional view of a third supplemental defining structure taken along the height direction;

FIG. 5 is a schematic view of the combination of the confinement structure and the auxiliary confinement structure in a cage-like configuration;

FIG. 6a is a schematic structural view of a first type of through-hole;

FIG. 6b is a schematic structural view of a second type of through-hole;

FIG. 6c is a schematic structural view of a third through-hole;

FIG. 7a is a schematic illustration of a first bone active substance delivery modality of the vertebral body fusion device;

FIG. 7b is a schematic illustration of a second bone active substance delivery modality of the vertebral body fusion device;

FIG. 8a is a schematic view of the syringe of the vertebral body fusion device;

FIG. 8b is an enlarged partial view of the distal end of the outer tube of the syringe of the vertebral body fusion device;

FIG. 9a is a schematic structural view of a non-slip structure being a mesh-shaped sheet;

FIG. 9b is a schematic view of a non-slip structure that is a compressible sheet;

wherein, 1 is a bag, 2 is a limiting mechanism, 3 is an injection tube, 11 is a supporting material, 12 is an injection port, 13 is an anti-skid structure, 14 is a connecting head, 15 is a bone grafting bin, 16 is a first through hole, 17 is a second through hole, 21 is a net-shaped sheet, 22 is an annular frame, 23 is a non-malleable flexible thread or wire, 24 is a foldable structure, 31 is an inner tube, 32 is an outer tube, 321 is an elastic bayonet, 4 is an auxiliary limiting structure, 41 is a sheet structure, and 42 is a connecting piece.

Detailed Description

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

As shown in fig. 1, the vertebral body fusion device accessed through a minimally invasive access comprises a bag 1 and a supporting material, wherein the bag 1 can be folded or contracted, an injection port 12 is arranged at one end of the bag 1, the supporting material 11 is injected into the bag 1 through the injection port 12, the contact surface of the bag 1 and upper and lower vertebral bodies is a vertebral body contact surface, a limiting mechanism 2 with a preset shape is arranged on the vertebral body contact surface, and when the bag 1 is implanted into an intervertebral disc and the injection of the supporting material is completed, the vertebral body contact surface of the bag 1 is in the preset shape.

The pouch 1 may be woven from implantable filaments, such as a woven body of PET wires; it may also be a membrane balloon made of an implantable material, such as sintered PTFE. By injecting a support material into the pouch 1, the vertebral body fusion device can be made to accommodate different vertebral body spaces without any step.

As shown in fig. 4c, the support material 11 is a self-setting bone filler material, such as bone cement. The support material 11 is in a fluid state during injection, and the support material 11 is injected into the bladder 1 to a desired shape, and the support material 11 is self-solidified within a short time, thereby providing stable support between the upper and lower vertebral bodies.

The vertebra contact surface of the bag 1 is provided with a limiting mechanism 2 with a preset shape, and the preset shape can be a square shape, a round shape and the like which are beneficial to supporting the upper vertebra body and the lower vertebra body. When the support material 11 is injected into the pouch 1, the pouch 1 is restrained by the restraining means 2 and the vertebral body contacting surface assumes a predetermined shape.

In one embodiment, the restraining mechanism 2 is a retractable structure. As shown in fig. 2a, the limiting means 2 is a mesh sheet 21, engraved or knitted, made of elastic material, fixed to the vertebral-contact surface of the pouch 1 by means of an adhesive or sewn connection that avoids complex mechanical fastening, making the fusion device compact. As shown in fig. 2b, the limiting means 2 may also be an annular frame 22 made of an elastic material. As shown in fig. 2c, the restricting means 2 may also consist of a plurality of inextensible flexible threads or filaments 23, which flexible threads or filaments 23 are woven crosswise and connect the periphery of the vertebral body contacting surface of the pouch 1. The attachment of the annular frame 22 and the plurality of non-malleable flexible threads or filaments 23 to the pouch 1 by means of adhesive or stitching avoids complex mechanical fastening, resulting in a reduced overall size of the fusion device when compressed.

In another embodiment, the restricting mechanism 2 is a foldable structure 24, and as shown in fig. 3, the foldable structure 24 is formed by connecting a plurality of sheets to each other and is secured to the vertebral body contacting surface of the bag 1, such that when the bag 1 is filled with the support material 11, the restricting mechanism 2 naturally unfolds with the bag 1 into a predetermined shape.

On the side of the bag 1, a retractable auxiliary limiting structure 4 is also arranged, the width of the auxiliary limiting structure is smaller than or equal to the width of the bag 1 in the natural filling state, so that when the bag 1 is filled by the supporting material 11, the side of the bag 1 cannot be arbitrarily bulged, the bone grafting volume is ensured not to be excessively occupied by the supporting material, and the fusion of vertebral bodies is facilitated.

In one embodiment, the auxiliary limiting structure 4 includes two sheet structures 41 and a connecting member 42 connecting the two sheet structures 41, and the sheet structures 41 and the connecting member 42 may be integrally formed, or may be formed by combining by a fixing method such as welding or bonding. As shown in fig. 4a, the sheet structure 41 is a mesh-shaped sheet material formed by carving or weaving, is made of an elastic material, and is fixed on the left and right opposite surfaces of the bag 1 by a bonding or sewing connection mode; the connecting member 42 is an arc-shaped structure, two ends of which connect the adjacent ends of the two sheet structures 41 to form the complete auxiliary limiting mechanism 4, and the whole body can be compressed. As shown in fig. 4b, the connecting member 42 may also be a plurality of rods or wires, which are arranged between the two sheet structures 21, for example, two ends of the plurality of rods or wires are respectively connected with the middle parts of the two sheet structures 41 to form the complete auxiliary limiting structure 4, which limits the filling shape of the bag.

In another embodiment, as shown in fig. 4c, the secondary confinement structure 4 is a plurality of non-stretchable flexible threads or wires, both ends of which are respectively connected to the left and right opposite surfaces of the pouch 1, and the unfolded length thereof is less than or equal to the width of the pouch 1. The width of the left and right opposite surfaces of the bag 1 is limited by a plurality of non-malleable flexible threads or wires, so that the side surfaces of the bag 1 cannot be arbitrarily bulged when being inflated.

The auxiliary limiting structure 4 and the limiting mechanism 2 can be integrally manufactured or combined in a split mode, so that the interference between the two is avoided, and the diameter of the compressed vertebral body fusion device is prevented from being influenced. As shown in fig. 5, the limiting mechanism 2 is a net structure, and the two sheet structures 41 of the auxiliary limiting mechanism 4 are also net structures and are matched with the limiting mechanism 2 to be connected into a cage structure, so that a connecting piece 42 is avoided, and the diameter of the whole vertebral body fusion device after being compressed is reduced.

The bag 1 sets up the through hole along the perpendicular to the direction of vertebra body contact surface, when bag 1 was in the natural filling state the through hole extends to the contact surface of lower vertebra body, the space that the through hole was injectd is bone grafting storehouse 15, its with the packing space mutual isolation in the bag can be to the interior injection bone active material of bone grafting storehouse 15 messenger upper and lower centrum fusion. The through-hole may be square (as shown in fig. 6 a) or circular (as shown in fig. 6 b). As shown in fig. 6c, there may be a plurality of through holes, and a communication passage is provided between the plurality of through holes. The plurality of bone grafting bins are beneficial to the injection of the subsequent bone active substances.

As shown in fig. 7a, a first through hole 16 communicating with the bone graft bin 15 is formed at a side of the bag 1, the injection port 12 is formed beside the first through hole 16, and after the supporting material 11 is injected into the bag 1 through the injection tube 3, a filling tube filled with a bone active material is inserted into the first through hole 16, thereby completing the implantation of the entire vertebral body fusion device.

As shown in figure 7b, a second through hole 17 communicated with the bone grafting bin 15 is arranged on the side surface of the bag 1, the injection port 12 is arranged on the peripheral surface of the through hole forming the bone grafting bin and is coaxial with the second through hole 17, so that the injection tube 3 for injecting the supporting material 11 and the filling tube for filling the bone active substance can be sleeved together when in preassembly, when in use, after the supporting material 11 is injected, the injection tube 3 can be pulled out to fill the bone active substance, and the operation is simple and continuous.

In one embodiment, a check valve is provided on the injection port 12 to prevent the support material filled in the bladder from leaking. The check valve is a one-way valve.

As shown in fig. 8a and 8b, a connector 14 is provided at the injection port 12, and the connector 14 is detachably connected with the injection tube 3. The detachable connection may be a threaded connection or a snap-in connection. As shown in fig. 8a, the injection tube 3 includes an inner tube 31 and an outer tube 32, the outer tube 32 is sleeved on the inner tube 31 and moves axially relative to the inner tube 31, an elastic bayonet 321 is disposed at a distal end of the outer tube 32, and the distal end of the inner tube 31 is connected with the connector 14 in a snap-fit manner through the elastic bayonet 321. When the inner tube 31 extends out of the elastic bayonet 321, the elastic bayonet 321 is expanded by force to adaptively match the connector 14 to realize fixed connection. As shown in FIG. 8b, when the inner tube 31 is retracted away from the elastic latch 321, the elastic latch 321 is not forced to return to close, and automatically disengages from the connector 14, so that the syringe 3 can be removed entirely. The elastic bayonet 321 arranged at the distal end of the outer tube 32 is snap-connected with the connector 14 of the injection port 12, so that not only can the operation be prevented from being influenced by the separation caused by the false rotation caused by the threaded connection, but also the overall wall of the injection tube 3 can be thinner by replacing the threads with the elastic bayonet.

In order to prevent the vertebral body fusion device from moving after being implanted into the body, an anti-slip structure 13 is arranged on the vertebral body contact surface of the bag 1, as shown in fig. 9a and 9b, the anti-slip structure 13 is an agnail or a bulge fixed on the surface of the bag, and is embedded with the upper vertebral body surface and the lower vertebral body surface to prevent the vertebral body fusion system from moving; as shown in FIG. 9a, the non-slip structure 13 may also be a mesh sheet, the support material 11 being forced to protrude from the cells of the mesh sheet to form cleats when the bag 1 is inflated; as shown in fig. 9b, the anti-slip structure 13 is a compressible sheet, which is arranged outside the bag 1 and on the surface of the compressible sheet contacting the vertebral body is provided with barbs or protrusions.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A vertebral body fusion device accessed via a minimally invasive approach, comprising: including bag (1) and supporting material (11), bag (1) can be folded or can shrink bag (1) one end of bag (1) sets up injection port (12), supporting material (11) pass through injection port (12) are injected into the inside of bag (1) to provide stable support between upper and lower centrum, bag (1) and the face of upper and lower centrum contact are the centrum contact surface be provided with limiting mechanism (2) of predetermineeing the shape on the centrum contact surface, limiting mechanism (2) are collapsible structure or foldable structure, work as bag (1) is implanted in the intervertebral disc and is accomplished when supporting material (11) are injected, the centrum contact surface of bag (1) is the shape of predetermineeing, realizes the non-grade adaptation intervertebral space height and controllable with the contact surface size of upper and lower centrum.

2. The minimally invasive access vertebral body fusion device of claim 1, wherein: the limiting mechanism (2) is a mesh sheet (21) which is carved or woven or an annular frame (22) which is made of elastic materials.

3. The minimally invasive access vertebral body fusion device of claim 1, wherein: the foldable structure is formed by connecting a plurality of sheets with each other and is in a preset shape after being unfolded.

4. The minimally invasive access vertebral body fusion device of claim 1, wherein: the vertebral body fusion device further comprises a retractable secondary confinement structure (4), said secondary confinement structure (4) being arranged on the side of the pouch (1) and having a width smaller than or equal to the width of the pouch (1) in its natural filling state.

5. The minimally invasive access vertebral body fusion device of claim 4, wherein: the auxiliary limiting structure (4) comprises two sheet-like structures (41) and a connecting piece (42) for connecting the two sheet-like structures (41).

6. The minimally invasive access vertebral body fusion device of claim 5, wherein: the two sheet-like structures (41) and the connecting piece (42) are made in one piece.

7. The minimally invasive access vertebral body fusion device of claim 5, wherein: the two sheet structures (41) and the connecting piece (42) are made by split combination.

8. The minimally invasive access vertebral body fusion device of claim 5, wherein: the connecting piece (42) is an arc-shaped structure, and two ends of the arc-shaped structure are connected with the adjacent ends of the two sheet-shaped structures (41).

9. The minimally invasive access vertebral body fusion device of claim 5, wherein: the connecting elements (42) are rods which are arranged between two of the sheet-like structures (41).

10. The minimally invasive access vertebral body fusion device of claim 5, wherein: the connecting element (42) is a plurality of wires arranged between two of the sheet-like structures (41).

11. The minimally invasive access vertebral body fusion device of claim 5, wherein: the sheet-like structure (41) is a mesh sheet that is engraved or woven.

12. The minimally invasive access vertebral body fusion device of claim 4, wherein: the auxiliary limiting structure (4) and the limiting mechanism (2) are made into a cage-shaped structure in a whole.

13. The minimally invasive access vertebral body fusion device of claim 4, wherein: the auxiliary limiting structure (4) and the limiting mechanism (2) are in a cage-shaped structure formed by split combination.

14. The minimally invasive access vertebral body fusion device of claim 1, wherein: the bag (1) is provided with a through hole along the direction vertical to the contact surface of the vertebral body.

15. The minimally invasive access vertebral body fusion device of claim 14 wherein: the space defined by the through hole is a bone grafting bin (15), and the bone grafting bin (15) is isolated from the inner space of the bag (1).

16. The minimally invasive access vertebral body fusion device of claim 14 wherein: the through holes are multiple, and communication channels are formed among the through holes.

17. The minimally invasive access vertebral body fusion device of claim 1, wherein: an anti-slip structure (13) is arranged on the vertebral body contact surface.

18. The minimally invasive access vertebral body fusion device of claim 17, wherein: the anti-skid structure (13) is a grid-shaped sheet material, and the supporting material (11) protrudes outwards from the grids of the grid-shaped sheet material under the stress to form anti-skid bulges.

19. The minimally invasive access vertebral body fusion device of claim 17, wherein: the anti-skid structure (13) is a compressible sheet, and barbs are arranged on the contact surface of the compressible sheet and the vertebral body.

20. The minimally invasive access vertebral body fusion device of claim 17, wherein: the anti-skid structure (13) is a compressible sheet, and a bulge is arranged on the surface of the compressible sheet, which is in contact with a vertebral body.

21. The minimally invasive access vertebral body fusion device of claim 17, wherein: the anti-slip structure (13) is a barb fixed on the surface of the bag (1).

22. The minimally invasive access vertebral body fusion device of claim 17, wherein: the anti-slip structure (13) is a protrusion fixed on the surface of the bag (1).

23. The minimally invasive access vertebral body fusion device of claim 1, wherein: a check valve is arranged on the injection port (12).

24. The minimally invasive access vertebral body fusion device of any one of claims 1-23 wherein: the support material (11) is a self-setting bone filler material.