A spinal endoscopic interbody fusion system

Abstract

The present invention discloses a spinal full-endoscopic intervertebral fusion system, which includes an intervertebral fusion device, a handle instrument, a bone cement injection assembly, and a bone paste injection assembly. The intervertebral fusion device of the present invention is coiled into a preset shape under the action of a guide wire at the distal end of the bone cement injection assembly. Bone cement is perfused into the fusion device through the bone cement injection assembly. After the bone cement solidifies, it stably supports the intervertebral space. Bone paste is perfused through the bone paste injection assembly to fill the remaining cavity of the intervertebral space, achieving the effect of postoperative fusion. The spinal full-endoscopic intervertebral fusion system of the present invention enables the whole-process visualization of surgical operations within the spinal endoscope channel, making the surgery safer. The minimally invasive spinal endoscope surgery is more minimally invasive, reduces nerve traction and harassment, lowers the risk of postoperative nerve complications, reduces intraoperative bleeding, improves the prognosis of patients, and shortens the operation time.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a fully endoscopic spinal intervertebral fusion system. Background Art

[0002] Degenerative diseases of the spine and damage to its structure are an important cause of pain in the neck, shoulders, waist and legs, and impairment or even loss of sensory and motor functions. In the 1950s, Cloward first proposed posterior lumbar intervertebral fusion (PLIF), which has developed into one of the basic procedures in spinal surgery today. In 1986, Badgy and Kuslich designed an intervertebral fusion cage (Cage) suitable for the human body, namely the BAK system. Since then, intervertebral bone grafting and fusion technology has made great progress and has become a basic surgical method for treating degenerative diseases and structural injuries of the spine.

[0003] The principle of the intervertebral fusion device is to center on the diseased intervertebral space. After the intervertebral fusion device is implanted, the expansion force puts the muscles, annulus fibrosus and anterior and posterior longitudinal ligaments of the fusion segment under continuous tension, so that the fusion segment and the fusion device achieve three-dimensional hyperstatic fixation. Secondly, the intervertebral fusion device restores the height of the intervertebral space to restore the stress and stability of the anterior and middle columns of the spine, restores and maintains the inherent physiological protrusion of the spine, expands the intervertebral foramen, and relieves the pressure on the dura mater sac and nerve roots. The hollow structure of the intervertebral fusion device provides a good mechanical environment for the fusion of the cancellous bone inside it, thereby achieving the purpose of permanent fusion of the interface.

[0004] Existing conventional fusion devices are generally a series of fixed-shaped blocks, such as box-type structures, which rely on a series of height models to adapt to different intervertebral spaces and cannot completely match the intervertebral spaces of patients. In addition, in order to achieve a good support effect, the support surface needs to be as large as possible during design, and the volume is large, which leads to a larger implantation channel, greater damage to patients, and slow recovery after surgery, which will bring both physical and psychological pain to patients. Although general minimally invasive surgery can reduce traumatic incisions and narrow the access channel of the fusion device, the mechanical structure of the fusion device can often only achieve variable height or width, and the two are incompatible in terms of height enhancement and vertebral contact area. The mechanical structure limits the bone grafting space, affects the fusion effect, and leads to poor surgical results. A second operation may be required, which brings a heavier burden to patients. Summary of the invention

[0005] The purpose of the present invention is to provide a fully endoscopic spinal intervertebral fusion system in view of the problems existing in the fusion cage in the prior art.

[0006] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0007] The present invention provides a spinal endoscopic interbody fusion system, which includes a foldable fusion device body, a handle instrument, a bone cement injection assembly, and a bone paste injection assembly; the fusion device body includes a distal head, a balloon, and a proximal head;

[0008] The fusion device body is coiled into a preset shape under the action of a guide wire at the distal end of the bone cement injection assembly, and bone cement is injected into the fusion device body. After solidification, it stably supports the intervertebral space.

[0009] Further, the guide wire has elastic memory deformation ability and can return to the preset shape after being straightened.

[0010] Further, the guide wire can guide the balloon to form a preset shape.

[0011] Further, the bone cement injection assembly further includes an outer bone cement tube, an inner bone cement tube, a handle connection head I, a limit block III, and a bone cement injection joint; the distal end of the outer bone cement tube is connected to the proximal end of the guide wire; channels are provided on the side walls of both the outer bone cement tube and the inner bone cement tube.

[0012] Further, a smooth film that does not react with bone cement is coated on the outer surfaces of the guide wire and the outer bone cement tube.

[0013] Further, after the bone cement assembly is removed, a complete cavity channel is left in the fusion device body, and the channel conveys the bone paste into the middle cavity of the fusion device body.

[0014] Further, the cross-section of the fusion device body is in a shape that is narrow on both sides and wide at the top and bottom.

[0015] Further, the balloon can adhere to the irregular shape on the cartilage endplate during bone cement filling and injection, and the anti-displacement ability of the fusion device body is greatly enhanced after the bone cement is solidified.

[0016] Further, the proximal end of the proximal head is a slot structure and is matched with the slot on the distal end of the inner tube of the handle instrument for the connection and release of the fusion device body and the handle instrument.

[0017] Further, the proximal end of the distal head and the distal end of the guide wire are a matching stepped structure to prevent relative sliding between the fusion device body and the guide wire when the fusion device body is released into the intervertebral disc.

[0018] Compared with the prior art, the present invention has the following advantages:

[0019] The fusion cage body of the spinal endoscopic interbody fusion system of the present invention is pre-coiled into a circle under the action of a guide wire, and then bone cement is injected for solidification. The special-shaped balloon can increase the amount of bone paste implanted in the later stage, thereby increasing the contact area between the fusion cage and the cartilage endplate and improving the fusion effect. In addition, under the combined action of the balloon and the guide wire, the amorphous bone cement is solidified into a pre-designed shape, so as to achieve good mechanical support and ensure the fusion effect.

[0020] The fusion cage of the spinal endoscopic interbody fusion system of the present invention can pass through a surgical working channel with a diameter of 5 mm or less, making the incision of the vertebral body fusion surgery smaller.

[0021] The filling materials of the spinal endoscopic interbody fusion system of the present invention are bone cement and bone paste. After the bone cement solidifies in the intervertebral disc, it can provide good mechanical support. In addition, by using the method of injecting bone cement and bone paste, the surgical operation can be reduced and the operation time can be shortened. Brief Description of the Drawings

[0022] Figure 1 is an overall schematic diagram of the spinal endoscopic interbody fusion system of the present invention when the fusion cage is constrained;

[0023] Figure 2 is an overall schematic diagram of the spinal endoscopic interbody fusion system of the present invention when the fusion cage is released from the constraint;

[0024] Figure 3 is an overall schematic diagram of the spinal endoscopic interbody fusion system of the present invention when the fusion cage is detached from the handle instrument;

[0025] Figure 4 is a structural schematic diagram of the fusion cage body of the spinal endoscopic interbody fusion system of the present invention;

[0026] Figure 5 is a half-sectional schematic diagram of the handle instrument of the spinal endoscopic interbody fusion system of the present invention;

[0027] Figure 6 is an exploded schematic diagram of the handle instrument of the spinal endoscopic interbody fusion system of the present invention;

[0028] Figure 7 is a half-sectional schematic diagram of the bone cement injection assembly of the spinal endoscopic interbody fusion system of the present invention;

[0029] Figure 8 is a schematic diagram of the distal end of the bone cement injection assembly of the spinal endoscopic interbody fusion system of the present invention in a natural state;

[0030] Figure 9 is an exploded schematic diagram of the bone cement injection assembly of the spinal endoscopic interbody fusion system of the present invention;

[0031] Figure 10 It is a schematic structural view of the bone cement tube of the spinal full-endoscopic intervertebral fusion system of the present invention;

[0032] Figure 11 It is a schematic structural view of the bone paste injection assembly of the spinal full-endoscopic intervertebral fusion system of the present invention;

[0033] Figure 12 It is a half-sectional schematic view of the bone paste injection assembly of the spinal full-endoscopic intervertebral fusion system of the present invention;

[0034] Figure 13 It is a schematic view of the morphology of the spinal full-endoscopic intervertebral fusion system of the present invention within the intervertebral disc. Detailed implementation manners

[0035] The present invention will be introduced in detail and specifically through specific embodiments to better understand the present invention. However, the following embodiments do not limit the scope of the present invention.

[0036] In the present invention, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far from the surgical operator.

[0037] Embodiment

[0038] This embodiment provides a spinal full-endoscopic intervertebral fusion system. Refer to Figures 1-3 and Figure 11 , which includes a fusion device main body 1, a handle instrument 2, a bone cement injection assembly 3, and a bone paste injection assembly 4.

[0039] Refer to Figure 4 , the above-mentioned fusion device main body 1 includes a balloon 12 and a stent 121 covered by the balloon 12. The balloon 12 can be folded to meet the requirements of minimally invasive implantation of the fusion device; the stent 121 is pre-shaped into an approximate ellipse and covered in the balloon 12; distal heads 11 and proximal heads 13 are fixedly installed at the two ends of the balloon 12 after closing the openings. The method used for the above fixation is to attach a layer of film outside the two ends of the balloon 12 after closing the openings, so that the balloon 12 is respectively fixed to the small bosses of the distal heads 11 and proximal heads 13;

[0040] Refer to Figures 1-3As shown in FIGS. 5-6, the handle instrument 2 includes an upper handle cover 21, a lower handle cover 22, a limiting block II 23, an injection assembly connector 24, and a fusion device grasping and releasing component 25. The fusion device grasping and releasing component 25 includes an outer tube 251, an inner tube 252, a pull head 253, and a limiting block I 254. The inner tube 252 is fixedly connected to the limiting block II 23, and the limiting block II 23 and the injection assembly connector 24 are respectively clamped in the ribs of the upper handle cover 21 and the lower handle cover 22; the distal end of the inner tube 252 is detachably connected to the proximal head 13 in a matching manner, and the proximal end of the inner tube 252 is fixedly connected to the injection assembly connector 24. The outer tube 251, the pull head 253, and the limiting block I 254 are sleeved outside the inner tube 252, and the movement of the outer tube 251 relative to the inner tube 252 is realized by pulling the pull head 253; the limiting block I is close to the distal ends of the upper handle cover 21 and the lower handle cover 22, and a notch is provided on the side of the limiting block I 254, and it can be peeled off from the inner tube 252.

[0041] See Figures 1-3 , which are three states during the operation of the instrument. By pulling the pull head 253, the outer tube 251 sleeved outside the inner tube 252 can be pulled to move back away from the fusion device main body 1, and the fusion device main body 1 is released from the constrained state. When the proximal end face of the pull head 253 abuts against the end face of the limiting block I 254, the fusion device main body 1 is completely released (as Figure 2 shown); then the limiting block I 254 is peeled off from the inner tube 252. After the limiting block I 254 is withdrawn, the pull head 253 continues to move back, realizing the complete detachment of the fusion device main body 1 (as Figure 3 shown).

[0042] See Figures 7-10 , the bone cement injection assembly 3 includes a guide wire 31 passing through the fusion device main body 1, a bone cement outer tube 32, a bone cement inner tube 33 sleeved inside the bone cement outer tube 32, a handle connector I 34, a limiting block III 35, and a bone cement injection joint 36. The guide wire 31 includes a guiding wire 311, an expanding tube 312, and a developing ring 313. The expanding tube 312 is a soft polymer material coated outside the nitinol wire, and its purpose is to occupy the volume of the bone cement and leave space for subsequent bone paste injection. The developing ring 313 is coated at both ends of the guide wire and is used to observe the forming state of the fusion device main body 1 during the above-mentioned imaging. In addition, a layer of PTFE film is coated outside the guide wire 31 and the bone cement outer tube 32 to facilitate the withdrawal of the bone cement injection assembly 3.

[0043] The distal end of the above-mentioned handle connector Ⅰ 34 is detachably connected to the injection assembly connector 24; the outer wall of the proximal end of the bone cement outer tube 32 is fixedly connected to the limiting block Ⅲ 35 arranged inside the handle connector Ⅰ 34, the proximal end of the bone cement inner tube 33 is fixedly connected to the bone cement injection joint 36, and the above-mentioned bone cement injection joint 36 is rotatable and sleeved inside the handle connector 34, so that the above-mentioned bone cement inner tube 33 can rotate relative to the bone cement outer tube 32. The above-mentioned limiting block Ⅲ 35 is sleeved inside the handle connector Ⅰ 34, and the proximal end of the bone cement outer tube 32 is fixedly connected to the limiting block Ⅲ 35. The boss on the limiting block Ⅲ 35 cooperates with the notch at the proximal end of the injection assembly joint 24. When the bone cement injection joint 36 rotates, it will not drive the bone cement outer tube 32 to rotate, thereby ensuring the stable position of the bone cement outer tube 32 and the guide wire 31 and restricting their rotation. The hole on the proximal end face of the distal head 11 is a stepped hole and can cooperate with the step at the distal end of the guide wire 31. When the pull head 253 is retracted, these stepped faces contact each other to prevent the slip of the fusion device main body 1.

[0044] See Figure 10 and Figure 9 , bone cement through holes are provided on the wall surfaces of the bone cement outer tube 32 and the bone cement inner tube 33 near the distal end. Marking lines are also provided on the handle connector 34 and the bone cement injection joint 36. When the bone cement injection joint 36 is rotated and the above two marking lines are aligned, the bone cement through holes respectively opened on the wall surfaces of the bone cement outer tube 32 and the bone cement inner tube 33 near the distal end coincide, and bone cement can be smoothly injected into the balloon 12. After the injection is completed, the bone cement injection joint 36 is rotated again to close the bone cement injection channel.

[0045] See Figure 7 and Figure 13 , the imaging rings 313 are arranged at both ends of the guide wire 31. In the natural state, the guide wire 31 is as Figure 8 shown. The function of the imaging rings 313 arranged at both ends of the guide wire 31 is to judge whether the fusion device main body 1 forms a closed ring in the intervertebral disc.

[0046] See Figures 11-12 , the full-endoscopic intervertebral fusion system of the present invention further includes an insertable bone paste injection assembly 4, and the above-mentioned bone paste injection assembly 4 includes a bone paste tube 41, a handle connector Ⅱ 42 and a bone paste injection joint 43; the proximal end of the bone paste tube 41 is fixedly connected to the bone paste injection joint 43, the distal end of the bone paste injection joint is a boss structure and is limited inside the handle joint Ⅱ 42, and the distal end of the handle connector Ⅱ 42 is detachably connected to the injection assembly connector 24. After the bone cement injection assembly 3 is removed, the bone paste injection assembly 4 is inserted into the injection assembly connector 24, and then the bone paste is injected.

[0047] Application Example

[0048] The operating principle of the full-endoscopic intervertebral fusion system of the present invention is as follows:

[0049] Step 1: During the operation, after the intervertebral disc is properly treated, when the fusion cage body 1 is in a constrained state (as shown in Figure 1 ), it is sent through the working channel of the endoscope to the opening of the intervertebral disc. One hand holds the pulling head 253, and the other hand holds the handle instrument 2 while slowly pushing the handle instrument 2. The fusion cage body 1 is released from the constrained state and placed inside the intervertebral disc. Due to the loss of the constraint of the outer tube 251, the fusion cage body 1 forms a ring (as shown in Figure 11 ); at the same time, according to the relative position of the imaging ring 313 through CT radiography, it is judged whether the annular fusion cage is formed in place;

[0050] Step 2: According to the marking lines provided on the handle connector Ⅰ 34 and the bone cement injection connector 36, rotate the bone cement injection connector 36 so that the two marking lines are aligned. At this time, the bone cement through holes near the distal wall surfaces of the bone cement outer tube 32 and the bone cement inner tube 33 coincide. Connect a matching bone cement injection instrument to the bone cement injection connector 36 and inject bone cement into the balloon 12; after the injection is completed, rotate the bone cement injection connector 36 again to close the bone cement injection channel. After the bone cement solidifies, loosen the handle connector Ⅰ 34 and remove the entire bone cement injection assembly 3. After removing the bone cement injection assembly 3, there is still a channel left inside the fusion cage body 1;

[0051] Step 3: Insert the bone paste injection assembly 4 so that the distal end of the bone paste tube 41 is located at the proximal end of the channel left in Step 2. Connect the bone paste injection assembly 4 to the handle instrument 2 through the handle connector Ⅱ 42 and the injection assembly connector 24; connect the bone paste injection connector 43 to a matching bone paste injection instrument and inject bone paste into the fusion cage body 1 (the channel left in Step 2). The bone paste will flow along the channel to the center of the fusion cage body 1. After the injection is completed, loosen the handle connector 42 and remove the bone paste injection assembly 4;

[0052] Step 4: Peel the limit block Ⅰ 254 from the outer tube 252, and continue to retract the pulling head 253. The fusion cage body 1 is separated from the rest of the parts (as shown in Figure 3 ), and the implantation of the annular fusion cage is completed.

[0053] The above are only the preferred embodiments of the present invention, and do not limit the implementation manners and protection scope of the present invention. For those skilled in the art, it should be realized that all the solutions obtained by equivalent substitution and obvious changes made by using the content of the specification of the present invention and the drawings should be included in the protection scope of the present invention.

Claims

1. A spinal full-endoscopic intervertebral fusion system, characterized in that, it includes a foldable fusion device main body (1), a handle instrument (2), a bone cement injection assembly (3) and a bone paste injection assembly (4); the fusion device main body (1) includes a distal head (11), a balloon (12) and a proximal head (13); the handle instrument (2) includes an upper handle cover (21), a lower handle cover (22), a limit block II (23), an injection assembly connector (24) and a fusion device grasping and releasing component (25); the fusion device grasping and releasing component (25) includes an outer tube (251), an inner tube (252), a pull head (253) and a limit block I (254); the inner tube (252) is fixedly connected to the limit block II (23), and the limit block II (23) and the injection assembly connector (24) are respectively clamped in the ribs of the upper handle cover (21) and the lower handle cover (22); the distal end of the inner tube (252) is detachably connected and matched with the proximal head (13), and the proximal end of the inner tube (252) is fixedly connected to the injection assembly connector (24); the bone cement injection assembly (3) includes a guide wire (31) passing through the fusion device main body (1), a bone cement outer tube (32), a bone cement inner tube (33) sleeved in the bone cement outer tube (32), a handle connector I (34), a limit block III (35) and a bone cement injection joint (36); the distal end of the bone cement outer tube (32) is connected to the proximal end of the guide wire (31); the guide wire (31) includes a guiding wire (311), an expanding tube (312) and a developing ring (313); the material of the expanding tube (312) is a soft polymer material; the distal end of the handle connector I (34) is detachably connected to the injection assembly connector (24); the proximal outer wall of the bone cement outer tube (32) is fixedly connected to the limit block III (35) arranged in the handle connector I (34), the proximal end of the bone cement inner tube (33) is fixedly connected to the bone cement injection joint (36), and the bone cement injection joint (36) is rotatable and sleeved in the handle connector I (34), so that the bone cement inner tube (33) can rotate relative to the bone cement outer tube (32); the boss on the limit block III (35) is matched with the notch at the proximal end of the injection assembly joint (24), and when the bone cement injection joint (36) is rotated, the bone cement outer tube (32) will not be driven to rotate, thereby ensuring the stable position of the bone cement outer tube (32) and the guide wire (31) and restricting their rotation; the fusion device main body (1) is coiled into a preset shape under the action of the guide wire (31) at the distal end of the bone cement injection assembly (3), and bone cement is injected into the fusion device main body (1), and after solidification, it stably supports the intervertebral space.

2. The spinal full-endoscopic intervertebral fusion system according to claim 1, characterized in that, the guide wire (31) has elastic memory deformation ability and can restore to the preset shape after being straightened.

3. The spinal full-endoscopic intervertebral fusion system according to claim 2, characterized in that, the guide wire (31) guides the balloon (12) to form a preset shape.

4. The full-endoscopic intervertebral fusion system under the spine according to claim 1, characterized in that, channels are provided on the side walls of the bone cement outer tube (32) and the bone cement inner tube (33).

5. The full-endoscopic intervertebral fusion system under the spine according to claim 4, characterized in that, a smooth membrane that does not react with the bone cement is coated on the guide wire (31) and the bone cement outer tube (32).

6. The full-endoscopic intervertebral fusion system under the spine according to claim 4, characterized in that, after the bone cement injection assembly (3) is withdrawn, a complete cavity channel is left in the fusion device main body (1), and the channel conveys the bone paste to the middle cavity of the fusion device main body (1).

7. The full-endoscopic intervertebral fusion system under the spine according to claim 1, characterized in that, the cross-section of the fusion device main body (1) is in a shape that is narrow on both sides and wide at the top and bottom.

8. The full-endoscopic intervertebral fusion system under the spine according to claim 1, characterized in that, the balloon (12) can adhere to the irregular shape on the cartilage endplate during bone cement filling and injection, and the anti-displacement ability of the fusion device main body (1) is greatly enhanced after the bone cement is solidified.

9. The full-endoscopic intervertebral fusion system under the spine according to claim 1, characterized in that, the proximal end of the proximal head (13) is a clamping groove structure and is matched with the clamping groove on the distal end of the inner tube (252) of the handle instrument (2) for the connection and release of the fusion device main body (1) and the handle instrument (2).

10. The full-endoscopic intervertebral fusion system under the spine according to claim 1, characterized in that, the proximal end of the distal head (11) and the distal end of the guide wire (31) are a matching stepped structure to prevent the relative sliding of the fusion device main body (1) and the guide wire (31) when the fusion device main body (1) is released into the intervertebral disc.

Images