阅读说明：本技术 一种采用球囊成型的围栏型骨水泥脊柱融合装置 (Fence type bone cement spine fusion device adopting balloon forming ) 是由 范双玲 张红导 李小雪 于 2021-04-06 设计创作，主要内容包括：一种采用球囊成型的围栏型骨水泥脊柱融合装置,包括球囊系统和内窥镜系统,球囊系统的外侧围栏型球囊与中央蝶形球囊之间通过球囊连接带进行固定连接,外侧围栏型球囊、中央蝶形球囊及球囊连接带固定连接后的整体缩放至球囊套管内,外侧围栏型球囊及中央蝶形球囊的后端均设计有独立的球囊打气接口,套管握柄套设于中央蝶形球囊打气接口和外侧围栏型球囊打气接口上,内窥镜系统包括工作鞘及内窥镜,内窥镜与工作鞘配合套接,球囊套管与内窥镜的器械通道配合套接并使套管握柄外露于器械通道的接口处；本发明可有效缩小手术切口,避免因施加外固定系统而导致的脊柱损伤。(A fence-type bone cement spine fusion device formed by a balloon comprises a balloon system and an endoscope system, wherein an outer fence-type balloon of the balloon system is fixedly connected with a central butterfly-shaped balloon through a balloon connecting band, the whole body of the outer fence-type balloon, the central butterfly-shaped balloon and the balloon connecting band after being fixedly connected is zoomed into a balloon sleeve, the rear ends of the outer fence-type balloon and the central butterfly-shaped balloon are respectively provided with an independent balloon inflating interface, a sleeve grab handle is sleeved on the central butterfly-shaped balloon inflating interface and the outer fence-type balloon inflating interface, the endoscope system comprises a working sheath and an endoscope, the endoscope is sleeved with the working sheath in a matching manner, the balloon sleeve is sleeved with an instrument channel of the endoscope in a matching manner, and the sleeve grab handle is exposed out of the interface of the; the invention can effectively reduce the surgical incision and avoid spinal injury caused by applying an external fixing system.)

1. A fence-type bone cement spine fusion device formed by a balloon comprises a balloon system and an endoscope system, and is characterized in that the balloon system comprises an outer fence-type balloon and a central butterfly-shaped balloon, the outer fence-type balloon and the central butterfly-shaped balloon are fixedly connected through a balloon connecting band, the whole body of the outer fence-type balloon, the central butterfly-shaped balloon and the balloon connecting band after being fixedly connected is contracted into a balloon sleeve, an outer fence-type balloon inflation interface is designed at the rear end of the outer fence-type balloon, a central butterfly-shaped balloon inflation interface is designed at the rear end of the central butterfly-shaped balloon, a sleeve grab handle is further arranged at the rear end of the balloon sleeve, the sleeve grab handle is sleeved on the central butterfly-shaped balloon inflation interface and the outer fence-type balloon inflation interface, the endoscope system comprises a working sheath and an endoscope, the endoscope comprises an instrument channel, the endoscope is matched and sleeved with the working sheath, the balloon sleeve is matched and sleeved with the instrument channel of the endoscope, and the sleeve grab handle is exposed out of the interface of the instrument channel.

2. An enclosure-type bone cement spinal fusion device formed by a balloon according to claim 1, wherein the number of balloon connecting bands is 8.

3. A fence-type bone cement spinal fusion device formed by adopting a balloon as recited in claim 1, wherein the shape of the outer fence-type balloon is an irregular ellipse shape, and the shape of the central butterfly-shaped balloon is an irregular butterfly shape.

4. An enclosure type bone cement spinal fusion device formed by a balloon according to claim 1, wherein the balloon sleeve, the central butterfly-shaped balloon inflation port and the outer enclosure type balloon inflation port are made of flexible tubes or high-pressure capillary tubes.

5. An enclosure-type bone cement spinal fusion device formed by a balloon as claimed in claim 1 wherein the endoscope system further includes a working sheath handle disposed at a trailing end of the working sheath for providing a gripping action to the working sheath.

6. An enclosure-type bone cement spinal fusion device formed by a balloon as claimed in claim 1 wherein the endoscope further comprises a flush joint, an optical fiber interface and a eyepiece interface, and the endoscope system further integrates a water inlet channel, an imaging channel, an illumination light channel and an instrument channel.

7. An enclosure-type bone cement spinal fusion device formed by a balloon as claimed in claim 6, wherein the flushing joint is mounted at the rear end of the working sheath handle, the flushing joint comprises a water inlet, a rotatable water inlet valve switch and a circular groove, the water inlet can be connected with a hose for water injection operation, and the rotatable water inlet valve switch is a flow control valve.

8. An enclosure-type bone cement spinal fusion device formed by a balloon according to claim 6, wherein the illumination light channel is internally distributed with optical fibers for providing an illumination field for surgery; and an optical system is integrated in the imaging channel and used for providing a stable imaging visual field for the operation.

9. An enclosure-type bone cement spinal fusion device formed by a balloon as claimed in claim 6 wherein the optical fiber interface and the eyepiece lens interface are sequentially disposed between the flush water joint and the instrument channel.

Technical Field

The invention relates to the technical field of intervertebral fusion, in particular to a balloon-formed fence-type bone cement spinal fusion device.

Background

In recent years, the proportion of the spinal fusion operation in the surgical operation is steadily increased, the operation process is mostly carried out by adopting a fusion device, specifically, after the fusion device is embedded and fixed to reach the required intervertebral space, the bone grafting process is put into the bone grafting cavity, the previous spinal fusion operation is completed by a fusion device matched external fixing system, the height of the intervertebral space is raised through external force support, and the physiological structure of the spinal column is recovered.

Most of the fusion devices on the market at present are fixed in size or expandable, the height of the fusion device is usually higher than that of an intervertebral space, the fusion device is large in size and is mostly suitable for open type operations, and a large wound surface is needed for performing the operations, so that the original spinal structure such as the articular process, the intervertebral disc fibrous ring and the like is damaged to generate the phenomenon of spinal instability, an external fixing system is required to be additionally arranged for fixing after the operations, the operation wound surface is large, the lumbar and back muscle stripping range is wide, and the recovery time is long; still another small part adopts passageway to transfer intervertebral fusion ware, has reduced the surface of a wound damage, nevertheless because of the working channel is too thick, the nerve root on the backbone is damaged very easily.

The fusion cage is small in size, damage to an organism caused by large operation wound surfaces is improved, contact area between the fusion cage and transverse and longitudinal surfaces of a spine is reduced due to small size, and therefore risk of secondary operations caused by collapse is increased.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides a balloon-molded fence-type bone cement spinal fusion device, which solves the problems of operation caused by larger or smaller size of the traditional fusion cage on the market, production cost increase caused by single production process and the like.

A fence-type bone cement spine fusion device formed by adopting a balloon comprises a balloon system and an endoscope system, wherein the balloon system comprises an outer fence-type balloon and a central butterfly-shaped balloon, the outer fence-type balloon and the central butterfly-shaped balloon are fixedly connected through a balloon connecting band, the whole body of the outer fence-type balloon, the central butterfly-shaped balloon and the balloon connecting band after being fixedly connected is zoomed into a balloon sleeve, the rear end of the outer fence-type balloon is provided with an outer fence-type balloon inflating interface, the rear end of the central butterfly-shaped balloon is provided with a central butterfly-shaped balloon inflating interface, the rear end of the balloon sleeve is also provided with a sleeve grab handle, the sleeve grab handle is sleeved on the central butterfly-shaped balloon inflating interface and the outer fence-type balloon inflating interface, the endoscope system comprises a working sheath and an endoscope, and the endoscope comprises an instrument channel, the endoscope is matched and sleeved with the working sheath, the balloon sleeve is matched and sleeved with the instrument channel of the endoscope, and the sleeve grab handle is exposed out of the interface of the instrument channel.

Preferably, the number of the balloon connecting bands is 8.

Preferably, the outer fence-type balloon is in an irregular oval shape, and the central butterfly-shaped balloon is in an irregular butterfly shape.

Preferably, the balloon sleeve, the central butterfly-shaped balloon inflating interface and the outer fence-type balloon inflating interface are made of hoses or high-pressure capillaries.

Preferably, the endoscope system further comprises a working sheath handle, and the working sheath handle is arranged at the tail end of the working sheath and used for providing a holding effect for the working sheath.

Preferably, the endoscope further comprises a flushing joint, an optical fiber interface and a mask lens interface, and a water inlet channel, an imaging channel and an illumination light channel are further integrated in the endoscope system.

Preferably, the bath connects and installs in the rear end of work sheath handle, the bath connects including the interface of intaking, rotatable intake valve switch, ring recess, the interface of intaking can external hose carry out the water injection operation, rotatable intake valve switch is the flow control valve.

Preferably, the illumination light channel is internally distributed with optical fibers for providing an illumination field for the operation; and an optical system is integrated in the imaging channel and used for providing a stable imaging visual field for the operation.

Preferably, the optical fiber interface and the eyepiece lens interface are sequentially arranged between the flushing joint and the instrument channel.

The invention has the beneficial effects that:

the balloon system of the spinal fusion device comprises a central butterfly-shaped balloon and an outer side fence-type balloon which are connected through a balloon connecting belt, the balloon system is in a shriveled and contracted state before being inflated, the size of the device is greatly reduced compared with that of a traditional fusion device, the device can be implanted through a minimally invasive channel to simplify the operation implantation process, and the intervertebral space can be lifted through inflation after the implantation; the fusion operation can be completed without lifting the intervertebral space by a large operation wound surface and operation space, the operation wound surface is obviously reduced, the possibility of nerve traction injury caused by the existing open wound surface implantation is reduced, and the problems of various complications caused by overlarge channel establishment injury, poor implantation position and the like are reduced.

In order to be suitable for the complicated spine structure of the human body, fusion devices with various specifications and shapes are needed, the existing fusion device is complicated in production process, the production cost is increased, and the medical expense of patients is indirectly increased. The balloon system provided by the invention can well replace fusion devices with various specifications and shapes, has simple production process, great operability of specification and shape change, reduces the production cost of instruments, effectively reduces the medical burden of patients, and increases the selectivity of the clinically required shapes and specifications; and avoids the use of external fixation systems and further avoids spinal injury resulting from the application of external fixation systems.

According to the invention, the balloon system is filled to naturally raise the intervertebral space, and the internal fixation effect is achieved through bone cement in the later period, so that the process that external force is firstly applied to raise the intervertebral space before the existing fusion cage is implanted and an external fixation system is applied after the existing fusion cage is implanted is avoided, the operation steps are simplified, and the operation risk is reduced; the adopted device has simple structure, and the contractible and preformed properties of the material can obtain the shape and specification required by any clinic, thereby solving the limitation of the specification and the size of the traditional fusion cage.

The spine fusion device can reduce the damage to the spine to the maximum extent through the minimally invasive incision, realize the maximum increase of the contact surface with the upper end plate and the lower end plate, increase the stability, inject bone cement into the gap between the inflated outer fence type saccule and the central butterfly saccule, solidify and shape the bone cement to form fixation, further form a fixed immovable bone grafting cavity, and increase the bone implantation amount and the contact area between the bone grafting and the end plate through central pressurization bone grafting, accelerate bone grafting fusion, avoid the displacement of bone grafting blocks and prevent the increase of the risk of secondary operations.

The spinal fusion device is integrally operated under an endoscope, so that visual operation is realized, the surgical field is increased, the surgical incision is effectively reduced, the postoperative reaction is light, and the recovery is fast.

Drawings

FIG. 1 is a schematic view of the overall construction of a spinal fusion device in accordance with the present invention;

FIG. 2 is a schematic view of the overall structure of the balloon system of the present invention after treatment with a cannula handle;

FIG. 3 is a schematic view of the overall structure of the balloon system of the present invention after inflation;

FIG. 4 is a schematic structural view of a balloon system of the present invention;

fig. 5 is a schematic structural view of the working sheath of the present invention.

In the figure: 1. a balloon sleeve; 2. a cannula grip; 3. a central butterfly-shaped balloon inflation interface; 4. an outer fence type balloon inflation interface; 5. an outer rail-type balloon; 6. a central butterfly balloon; 7. a balloon connecting band; 8. a working sheath; 9. a working sheath handle; 10. an endoscope; 11. a flushing connector; 12. an optical fiber interface; 13. a mask mirror interface; 14. an instrument channel.

Detailed Description

The invention is further described with reference to the drawings and the detailed description.

Example 1:

as shown in fig. 1 to 5, a balloon system used in the invention comprises an outer-side-rail-type balloon 5 and a central butterfly-shaped balloon 6, wherein the outer-side-rail-type balloon 5 is in an irregular oval shape, the central butterfly-shaped balloon 5 is in an irregular butterfly shape, the outer-side-rail-type balloon 5 is arranged outside the central butterfly-shaped balloon 6, and the two are fixedly connected through 8 balloon connecting bands 7 to form a fixed balloon device, and finally the whole body formed by fixedly connecting the outer-side-rail-type balloon 5, the central butterfly-shaped balloon 6 and the balloon connecting bands 7 is contracted into the balloon sleeve 1, so that the bone cement can be effectively prevented from deviating from one side during the injection of the bone cement through the fixing effect of the balloon connecting bands 7, and 8 sacculus connecting bands 7 can be a set of every 4, and two sets of distributions can provide more stable holding power when aerifing at the holistic top and the bottom of sacculus. The rear end of the outer fence type balloon 5 is provided with an outer fence type balloon inflation interface 3, similarly, the rear end of the central butterfly-shaped balloon 6 is also provided with a central butterfly-shaped balloon inflation interface 3, and the two inflation interfaces are independently communicated with the insides of the respective balloons; the rear end of the balloon sleeve 1 is also provided with a sleeve grab handle 2, and the sleeve grab handle 2 is sleeved on the central butterfly-shaped balloon inflating interface 3 and the outer fence-shaped balloon inflating interface 4 and is used for operating the outer fence-shaped balloon 5 and the central butterfly-shaped balloon 6 in the operation process.

The endoscope system adopted by the invention, namely the endoscope with an instrument channel which is ubiquitous in medicine, is commonly matched with the endoscope used in spinal surgery in medicine for use together, the endoscope system adopted by the invention comprises a working sheath 8 and an endoscope 10, the endoscope 10 also comprises an instrument channel 14, and after the endoscope 10 is matched and sleeved with the working sheath 8, the balloon sleeve 1 is finally matched and sleeved with the instrument channel 14 of the endoscope, and the sleeve handle 2 is exposed out of the interface of the instrument channel 14.

The balloon sleeve 1, the central butterfly-shaped balloon inflation interface 3 and the outer fence-type balloon inflation interface 4 are preferably made of hoses or high-pressure capillaries, and can also be made of other hoses or capillaries with medical use properties, but the reliability of the materials is required to be guaranteed, and the balloons have medical use properties.

In order to improve the operation convenience of medical staff and improve the operation visual field and visual field imaging, the endoscope system also comprises a working sheath handle 9 and other components, which are arranged at the tail end of the working sheath 8 and used for providing holding function for the working sheath 8; the endoscope 10 further comprises a flushing joint 11, an optical fiber interface 12 and a mask mirror interface 13, wherein the optical fiber interface 12 and the mask mirror interface 13 are sequentially arranged between the flushing joint 11 and the instrument channel 14. The flushing connector 11 is arranged at the rear end of the working sheath handle 9, the flushing connector 11 comprises a water inlet interface, a rotatable water inlet valve switch and a circular groove, the water inlet interface can be externally connected with a hose to perform water injection operation, and the rotatable water inlet valve switch is a common flow control valve; the endoscope system is also internally integrated with a water inlet channel, an imaging channel and an illuminating light channel, and the illuminating light channel is internally distributed with optical fibers and used for providing an illuminating view field for the operation; the imaging channel is internally integrated with an optical system for providing a stable imaging field for operation.

Example 2:

as shown in fig. 1 to 3, by performing the intervertebral fusion operation using the spinal fusion device manufactured in the above embodiment 1, when the balloon system of the present invention is not used, the whole of the outer rail-type balloon 5, the central butterfly-shaped balloon 6 and the balloon connecting band 7 after being fixedly connected is retracted into the balloon sleeve 1, as shown in fig. 1; when pushed forward with the cannula handle 2, the balloon system of the present invention becomes a deflated and deflated state, which is still uninflated, as shown in fig. 2; before the saccule is released, the saccule can be implanted or implanted between two vertebral body end plates of a minimally invasive incision through an endoscope system, after the saccule is released, the two saccules can be inflated, expanded and expanded through the outside fence type saccule 5 and the central butterfly type saccule 6, and then the intervertebral end plates are expanded, intervertebral spaces are lifted, and bone cement is implanted; the inflation can be carried out by an inflator pump or a large-capacity injector through the inflation interfaces of the two balloons.

As shown in fig. 1 to 3, the spinal fusion device of the present invention implements a minimally invasive fusion procedure in a specific embodiment as follows:

balloon implantation: firstly, a working sheath 8 is placed into a minimally invasive incision to establish a working channel, the working sheath 8 is butted with an endoscope 10 to realize subsequent visual operation, a balloon system is placed between two adjacent vertebral end plates through an instrument channel 14 of the endoscope, the sleeve grab handle 2 is pushed to release the balloons at the moment, then inflation equipment is used to respectively inflate the two balloons through an outer fence type balloon inflation interface 3 and a central butterfly-shaped balloon inflation interface 4, so that the two balloons are inflated, expanded and expanded, the end plates are expanded through expansion, intervertebral gaps are lifted, and the original height of the intervertebral space is recovered;

injecting bone cement: injecting bone cement into the gap between the outer fence type balloon 5 and the central butterfly-shaped balloon 6 by using a bone cement device through an instrument channel 14 of the endoscope, and forming a bone grafting cavity which plays a role in supporting intervertebral space after the bone cement is solidified;

removal of the central butterfly balloon 6: after the bone cement is solidified and shaped, cutting off the balloon connecting band 7, discharging the gas of the central butterfly-shaped balloon 6, taking out the central butterfly-shaped balloon 6, and supporting the central butterfly-shaped balloon 6 by the bone cement and the outer fence-type balloon 5 after the central butterfly-shaped balloon 6 is taken out;

bone grafting: processing the upper and lower end plates by using an instrument channel 14 of the endoscope, performing a central pressurizing bone grafting process, and injecting bone fillers into a bone grafting cavity formed by bone cement;

removal of outer rail type balloon 5: after completion of the bone grafting, the outer rail type balloon 5 is deflated by discharging the gas, and then cut by a medical instrument and pulled out through the instrument channel 14.

Various other modifications and changes may be made by those skilled in the art based on the above-described technical solutions and concepts, and all such modifications and changes should fall within the scope of the claims of the present invention.