阅读说明：本技术 一种防泄漏椎体成形器及其使用方法 (Anti-leakage vertebral body shaper and using method thereof ) 是由 张强 丁洪伟 于 2021-07-03 设计创作，主要内容包括：本申请公开了一种防泄漏椎体成形器,包括支撑探针、椎体扩张球囊外导管、椎体扩张球囊内导管及球囊压力扩张装置,支撑探针穿入到椎体扩张球囊外导管内,椎体扩张球囊外导管内套有所述椎体扩张球囊内导管,椎体扩张球囊外导管连接球囊压力扩张装置。具有以下优点：解决骨水泥灌浇效果不好、压缩体积难于确定的问题,减小了手术风险,显著提高手术精度和成功率。(The application discloses prevent leaking centrum shaper, including support probe, the outer pipe of centrum expansion sacculus, pipe and sacculus pressure expansion device in the centrum expansion sacculus, support probe penetrates in the outer pipe of centrum expansion sacculus, and the outer pipe endotheca of centrum expansion sacculus has pipe in the centrum expansion sacculus, the outer pipe connection sacculus pressure expansion device of centrum expansion sacculus. Has the following advantages: the problems that the bone cement pouring effect is poor and the compression volume is difficult to determine are solved, the surgical risk is reduced, and the surgical precision and the success rate are obviously improved.)

1. A leak-proof vertebral body shaper, comprising: including supporting probe (1), centrum expansion sacculus outer catheter (2), centrum expansion sacculus inner catheter (3) and sacculus pressure expansion device, supporting probe (1) penetrates in centrum expansion sacculus outer catheter (2), and centrum expansion sacculus outer catheter (2) endotheca has pipe (3) in the centrum expansion sacculus, sacculus pressure expansion device is connected in centrum expansion sacculus outer catheter (2).

2. A leak resistant vertebral body shaper as defined in claim 1, wherein: the supporting probe (1) comprises a probe handle (11) and a probe rod part (12), the outer catheter (2) of the vertebral body expansion balloon comprises an umbrella-shaped sedan type expansion balloon (21) and an injection port (22) which are far away from the end of the supporting probe (1), and a Y-shaped connector which is close to the end far away from the supporting probe (1).

3. A leak resistant vertebral body shaper as defined in claim 2, wherein: the Y-shaped connector comprises a connecting conduit (25) and an interface (26), the supporting probe (1) penetrates into one end of the connecting conduit (25), the other end of the connecting conduit (25) is connected with one end of a main body conduit (27), the other end of the main body conduit (27) is connected with one end of an umbrella-shaped car type expansion balloon (21), and the other end of the umbrella-shaped car type expansion balloon (21) is connected with the injection port (22).

4. A leak resistant vertebral body shaper as defined in claim 3, wherein: the middle part of the main body catheter (27) is provided with a first middle depth limiting marking line (23) and a second middle depth limiting marking line (24) which play a role in depth limiting in the operation;

the catheter (3) in the vertebral body expansion balloon extends into the umbrella-shaped car type expansion balloon (21) and is stopped at the injection port (22);

the interface (26) is connected with a one-way valve.

5. A leak resistant vertebral body shaper as defined in claim 3, wherein: the balloon pressure expansion device comprises a piston handle (4), a piston ring (5), a pressure mechanism (7) and a pressure gauge (6), wherein the pressure mechanism (7) comprises a pressure cavity (71), a hollow hose (72) and a hose locking joint (73), the two ends of the hollow hose (72) are respectively connected with the pressure cavity (71) and the hose locking joint (73), and the hose locking joint (73) is connected with an interface (26).

6. A method of using a leak resistant vertebral body shaper as defined in any of claims 1-5, wherein: the using method comprises the following steps:

step one, determining the injection amount of bone cement in a vertebral body;

and step two, after fracture, injecting bone cement into the fractured vertebra after the vertebral body is expanded, wherein the bone cement is equivalent to a bearing wall of a building and supports the diseased vertebra, so that the fractured end of the fractured vertebra is relatively stable, and the pain of the waist and the back caused by the stimulation of peripheral nerves of the fractured end is reduced, so that the pain of the waist and the back can be relieved by the support of the bone cement.

7. A leak resistant vertebral body shaper as recited in claim 6, wherein: the first step specifically comprises the following steps:

step 1, calculating a compressed volume;

measuring the compression height of the vertebral body and the cross-sectional area of the vertebral body according to the compressed CT digital image of the vertebral body;

step 2, carrying out quantitative expansion in the vertebral body;

the double-tube navigation needle is punctured into a pathological vertebral body by utilizing the known technology, and the umbrella-shaped car support is opened for quantitative expansion according to the measured compression volume and the subsidence height of the vertebral body;

step 3, contrast agent radiography;

injecting a contrast agent into the umbrella-shaped car type closed bracket through a double-cavity contrast pipeline, and restoring the compressed vertebral body by adjusting the amount of the contrast agent to complete the preparation work of cement pouring;

step 4, adjusting the accurate quantity;

in order to solve the problem of bone cement injection amount, a mathematical model for quantitative estimation and calculation is established;

and 5, calculating the vertebral body injection amount according to the injection amount model.

8. A leak resistant vertebral body shaper as recited in claim 7, wherein: the establishment of the mathematical model in the step 4 comprises the following steps:

(1) a two-dimensional polynomial and a two-order polynomial are used for establishing a mathematical model of the injection amount, and fitting is carried out through a least square method;

the variable injection amount is set as g, the height of the vertebral body needing to be actually recovered is set as h, the area of the vertebral body is set as s, the three components are supposed to satisfy a three-dimensional two-order polynomial,

g＝f(h,s)＝p₁₀h+p₀₁s+p₂₀h²+p₁₁h*s+p₀₂s²+p₀₀

where p is the coefficient of a polynomial expressed in matrix form as:

(2) the least square solution is solved by using the matlab cftool and the generalized inverse, and the function and the using method are briefly described as follows:

ft ═ fittype ('poly 22'); % specifies using a generalized inverse fit to a 2-dimensional 2-order equation;

[ P, gof ] ═ fit ([ H, S ], G, ft); % solving model parameters P, wherein gof stores relevant information of statistical error lamps, and input parameters are constructed as follows:

partial clinical data were selected: injection amount g_iThe height of the vertebral body to be restored is h_iThe area of the vertebral body is s_iConstructing a matrix G ═ G₁ g₂ ……]′，H＝[h₁ h₂ ……]′，S＝[s₁ s₂ ……]' substituting the matlab function to obtain a least square solution of the model parameter P;

P＝[0.014380.2120.07639-0.053200.0842190.5463]；

that is, the vertebral body injection volume model can be expressed as:

g＝0.212*h+0.07639*s±0.0532*h²+0.084219*h*s+0.5463s²+0.01438。

Technical Field

The invention relates to the technical field of medical instruments, in particular to a leakage-proof vertebral body shaper and a using method thereof.

Background

Percutaneous balloon dilatation vertebroplasty (PKP) is widely applied to patients with osteoporotic vertebral compression fracture at present, and the technique can rapidly form the osteoporotic vertebral compression fracture and recover the functions of the patients, and is a common orthopedic operation method. However, there is a risk of leakage of the cement during the operation of this technique. In surgery, without clear data controls, clinical experience is a significant contributor to success or failure of surgery. The vertebral compression fracture has different compression degrees according to different stress, the correct judgment of the compression volume is an important mark for determining the quantification of the bone cement filler and is also a theoretical basis for supporting the support height of the injured part, and the traditional filling takes an empirical value as a standard, so that the operation effect is different from person to person; in the bone cement injection process, if the bone cement injection is not well mastered, the bone cement can seep out from the parts of the damaged vertebral body fracture, the vertebral body back wall and the like to form irreversible damage, thereby greatly increasing the operation risk.

The thoracolumbar vertebral body is characterized in that a cortical bone layer on the periphery is hard, which is equivalent to a paper box in daily life, a trabecular bone trabecula of cancellous bone is arranged in the paper box, the trabecular bone trabecula of an osteoporosis patient is of a honeycomb-shaped net structure, and is loose, and in the process of expanding the vertebral body saccule, the loose trabecular bone trabecula can be extruded by external force of the expansion saccule to 'give way' towards the periphery to form a saccular cavity; the compressed vertebral body height begins to recover after the balloon pressure reaches a certain level. Therefore, theoretically, the volume of the vertebral body compression before the operation is smaller than the volume of the actual expansion; that is, the amount of bone cement we actually inject is greater than what we need for preoperative measurements.

The rule of data volume is summarized according to the prior clinical data to accurately confirm the injected volume, however, the rule is not shown in the prior clinical data, and the injected volume is not only related to the 'collapse' volume of the vertebral body, but also related to whether bone cement leaks, leaking parts and the like; the bone area is influenced by the osteoporosis degree of the trabecular bone, the osteoporosis degree is related to the age, the age simultaneously influences the bone area, the cross influence relationship is obviously a multi-dimensional and higher-order complex cross relation, and the operation is difficult to find an intuitive rule through past clinical data and can only be performed through experience and feeling of an operator.

Disclosure of Invention

Aiming at the problems, the invention provides a leakage-proof vertebral body shaper and a use method of accurate injection, solves the problems of poor bone cement pouring effect and difficult determination of compression volume, reduces surgical risks, and obviously improves surgical precision and success rate.

In order to solve the technical problems, the invention adopts the following technical scheme:

a leak-proof vertebral body former comprises a supporting probe, a vertebral body expansion balloon outer catheter, a vertebral body expansion balloon inner catheter and a balloon pressure expansion device, wherein the supporting probe penetrates into the vertebral body expansion balloon outer catheter, the vertebral body expansion balloon outer catheter is sleeved with the vertebral body expansion balloon inner catheter, and the vertebral body expansion balloon outer catheter is connected with the balloon pressure expansion device.

Further, the support probe comprises a probe handle and a probe rod part, and the outer catheter of the vertebral body expansion balloon comprises an umbrella-shaped car-type expansion balloon far away from the end of the support probe and an injection port, and is close to a Y-shaped connector far away from the end of the support probe.

Further, Y connector includes connecting tube and interface, and the support probe penetrates the one end of connecting tube, and the other end of connecting tube is connected with main part pipe one end, and the umbrella form car formula expansion sacculus one end is connected to the main part pipe other end, and the filling opening is connected to the umbrella form car formula expansion sacculus other end.

Furthermore, a first middle depth limiting marking line and a second middle depth limiting marking line are arranged at the middle part of the main body catheter, so that the effect of depth limiting in the operation is achieved;

the catheter in the vertebral body expansion balloon extends into the umbrella-shaped car type expansion balloon and stops at the filling opening;

the interface is connected with a one-way valve.

Further, the sacculus pressure expanding unit includes piston handle, piston ring, pressure mechanism and manometer, and pressure mechanism includes pressure chamber, hollow hose and hose locking joint, and the both ends of hollow hose are connected pressure chamber and hose locking joint respectively, and hose locking joint connects the interface.

A method of using a leak resistant vertebral body shaper, comprising the steps of:

step one, determining the injection amount of bone cement in a vertebral body;

and step two, after fracture, injecting bone cement into the fractured vertebra after the vertebral body is expanded, wherein the bone cement is equivalent to a bearing wall of a building and supports the diseased vertebra, so that the fractured end of the fractured vertebra is relatively stable, and the pain of the waist and the back caused by the stimulation of peripheral nerves of the fractured end is reduced, so that the pain of the waist and the back can be relieved by the support of the bone cement.

Further, the step one specifically includes the following steps:

step 1, calculating a compressed volume;

measuring the compression height of the vertebral body and the cross-sectional area of the vertebral body according to the compressed CT digital image of the vertebral body;

step 2, carrying out quantitative expansion in the vertebral body;

the double-tube guide needle is placed into the pathological vertebral body through the vertebral pedicle by utilizing the known technology, and the umbrella-shaped car support is opened for quantitative expansion according to the measured compression volume and the subsidence height of the vertebral body;

step 3, contrast agent radiography;

injecting a contrast agent into the umbrella-shaped car type closed bracket through a double-cavity contrast pipeline, and restoring the compressed vertebral body by adjusting the amount of the contrast agent to complete the preparation work of cement pouring;

step 4, adjusting the accurate quantity;

in order to solve the problem of bone cement injection amount, a mathematical model for quantitative estimation and calculation is established;

and 5, calculating the vertebral body injection amount according to the injection amount model.

Further, the establishment of the mathematical model in step 4 comprises the following steps:

1, establishing a mathematical model of the injection amount by using a two-dimensional polynomial and a two-order polynomial, and fitting by a least square method;

the variable injection amount is set as g, the height of the vertebral body needing to be actually recovered is set as h, the area of the vertebral body is set as s, the three components are supposed to satisfy a three-dimensional two-order polynomial,

g＝f(h，s)＝p₁₀h+p₀₁s+p₂₀h²+p₁₁h*s+p₀₂s²+p₀₀

where p is the coefficient of a polynomial expressed in matrix form as:

2, using a matlab cftool to solve a least square solution by using a generalized inverse, wherein the function and the using method are briefly described as follows:

ft ═ fittype ('poly 22'); % specifies using a generalized inverse fit to a 2-dimensional 2-order equation;

[ P, gof ] ═ fit ([ H, S ], G, ft); % solving model parameters P, wherein gof stores relevant information of statistical error lamps, and input parameters are constructed as follows:

partial clinical data were selected: injection amount g_iThe height of the vertebral body to be restored is h_iThe area of the vertebral body is s_iConstructing a matrix G ═ G₁ g₂……]′，H＝[h₁ h₂……]′，S＝[s₁ s₂……]' substituting the matlab function to obtain a least square solution of the model parameter P;

P＝[0.014380.2120.07639-0.053200.0842190.5463]；

that is, the vertebral body injection volume model can be expressed as:

g＝0.212*h+0.07639*s±0.0532*h²+0.084219*h*s+0.5463s²+0.01438。

by adopting the technical scheme, compared with the prior art, the invention has the following technical effects:

the utility model provides a percutaneous double-barrelled car formula umbelliform attached to centrum shaper technique of preventing leaking, can compress CT digital image according to the centrum, measure centrum compression height, and centrum cross-sectional area, calculate the compression volume, when percutaneous puts into the pathological change centrum with double-barrelled guide pin through the pedicle of vertebral arch, carry out quantitative expansion according to the compression volume of calculating and the centrum height that sinks, open umbelliform car support, then inject the contrast medium into umbelliform car airtight support through two-chamber radiography pipeline, through adjusting the contrast medium volume to restore the centrum of compression, accomplish bone cement and pour preparation work, can survey out bone cement volume according to accurate algorithm according to patient's physique change and comprehensive parameter this moment, accomplish the operation work.

Drawings

In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

FIG. 1 is a schematic structural view of a leak-proof vertebral body shaper of the present invention;

FIG. 2 is a schematic structural diagram of the capsule expansion device of the present invention;

FIG. 3 is a diagram of a vertebral body injection estimation model according to the present invention.

Detailed Description

In the embodiment, as shown in fig. 1, a leak-proof vertebral body shaper comprises a supporting probe 1, an external catheter 2 of a vertebral body expansion balloon and an internal catheter 3 of the vertebral body expansion balloon, wherein the supporting probe 1 penetrates into the external catheter 2 of the vertebral body expansion balloon, the internal catheter 3 of the vertebral body expansion balloon is sleeved in the external catheter 2 of the vertebral body expansion balloon, support probe 1 includes probe handle 11 and probe pole portion 12, outer pipe 2 of centrum expansion sacculus is including keeping away from umbelliform sedan-chair expansion sacculus 21 and the filling opening 22 of support probe 1 end, be close to the Y connector of keeping away from support probe 1 end, Y connector includes connecting tube 25 and interface 26, support probe 1 penetrates connecting tube 25's one end, connecting tube 25's the other end is connected with main part pipe 27 one end, 21 one end of umbelliform car expansion sacculus is connected to the main part pipe 27 other end, filling opening 22 is connected to 21 other end of umbelliform car expansion sacculus.

The umbrella-shaped car type expansion balloon 21 can be expanded to expand and compress the vertebral body, the umbrella-shaped car type expansion balloon maintains the expansion state after being contracted, and a cavity is formed in the vertebral body

The middle part of the main body conduit 27 is provided with a first middle depth limiting marking line 23 and a second middle depth limiting marking line 24, which play a role of depth limiting in the operation.

The catheter 3 in the vertebral body expansion balloon extends into the umbrella-shaped sedan type expansion balloon 21 and is stopped at the injection opening 22.

A one-way valve is connected to the interface 26.

As shown in fig. 2, the anti-leakage vertebral body shaper further comprises a balloon pressure expanding device, the balloon pressure expanding device comprises a piston handle 4, a piston ring 5, a pressure mechanism 7 and a pressure gauge 6, the pressure mechanism 7 comprises a pressure chamber 71, a hollow hose 72 and a hose locking joint 73, and two ends of the hollow hose 72 are respectively connected with the pressure chamber 71 and the hose locking joint 73.

The hose locking connector 73 can be connected to the interface 26 to form a complete leak-proof vertebral body shaper system, and before operation, contrast agent for balloon expansion can be injected into the pressure cavity 71 through the hose locking connector 73 and the hollow hose 72; in operation, the piston handle 4 pushes the piston ring 5 under the action of external force of an operator to inject the contrast agent injected into the pressure cavity 71 into the umbrella-shaped car type expansion balloon 21 sequentially through the hollow hose 72, the hose locking joint 73, the connector 26 of the one-way valve, the catheter 2 and the injection port 22, so as to complete the expansion of the vertebral body balloon; the pressure of the umbrella-shaped car-type dilatation balloon 21 can be displayed on the pressure gauge 6.

A method of using a leak resistant vertebral body shaper comprising the steps of:

the method comprises the following steps of firstly, determining the injection amount of bone cement in a vertebral body, and specifically comprises the following steps:

step 1, calculating a compressed volume;

and measuring the compression height of the vertebral body and the cross-sectional area of the vertebral body according to the compressed CT digital image of the vertebral body.

Step 2, carrying out quantitative expansion in the vertebral body;

the double-tube guide needle is placed into the pathological vertebral body through the vertebral pedicle by utilizing the known technology, and the umbrella-shaped car support is opened for quantitative expansion according to the measured compression volume and the subsidence height of the vertebral body.

Step 3, contrast agent radiography;

injecting a contrast agent into the umbrella-shaped car type closed bracket through the double-cavity contrast pipeline, and restoring the compressed vertebral body by adjusting the contrast agent amount to complete the preparation work of cement pouring.

Step 4, adjusting the accurate quantity;

in order to solve the problem of bone cement injection amount, according to the previous clinical data, the rule is not shown, the injected volume is not only related to the vertebral body collapse volume, but also influenced by the trabecular bone osteoporosis degree, the osteoporosis degree is related to the age, the age simultaneously influences the bone area, the cross influence relationship is obviously a multi-dimensional and higher-order complex cross relation, and the intuitive rule is difficult to find through the past clinical data.

The key point is to establish a mathematical model of quantitative estimation calculation, and the mathematical model of quantitative estimation calculation is verified according to partial clinical data by using a polynomial to fit the injection amount.

1, establishing a mathematical model of the injection amount by using a two-dimensional polynomial and a two-order polynomial, and fitting by a least square method;

the variable injection amount is set as g, the height of the vertebral body needing to be actually recovered is set as h, the area of the vertebral body is set as s, the three components are supposed to satisfy a three-dimensional two-order polynomial,

g＝f(h，s)＝p₁₀h+p₀₁s+p₂₀h²+p₁₁h*s+p₀₂s²+p₀₀

where p is the coefficient of a polynomial expressed in matrix form as:

2, using a matlab cftool to solve a least square solution by using a generalized inverse, wherein the function and the using method are briefly described as follows:

ft ═ fittype ('poly 22'); % specifies using a generalized inverse fit to a 2-dimensional 2-order equation;

[ P, gof ] ═ fit ([ H, S ], G, ft); % solving model parameters P, wherein gof stores relevant information of statistical error lamps, and input parameters are constructed as follows:

partial clinical data were selected: injection amount g_iThe height of the vertebral body to be restored is h_iThe area of the vertebral body is s_iConstructing a matrix G ═ G₁ g₂……]′，H＝[h₁ h₂……]′，S＝[s₁ s₂……]' substituting the matlab function to obtain a least square solution of the model parameter P;

P＝[0.014380.2120.07639-0.053200.0842190.5463]；

that is, the vertebral body injection volume model can be expressed as:

g＝0.212*h+0.07639*s±0.0532*h²+0.084219*h*s+0.5463s²+0.01438。

the vertebral body injection volume estimation model is shown in fig. 3 below.

And 5, calculating the vertebral body injection amount according to the injection amount model.

And step two, after fracture, injecting bone cement into the fractured vertebra after the vertebral body is expanded, wherein the bone cement is equivalent to a bearing wall of a building and supports the diseased vertebra, so that the fractured end of the fractured vertebra is relatively stable, and the pain of the waist and the back caused by the stimulation of peripheral nerves of the fractured end is reduced, so that the pain of the waist and the back can be relieved by the support of the bone cement. The bone cement forms an up-down long column shape on the left side and the right side in the vertebral body, and the bone cement structure dispersed to the periphery is the most ideal.

The problem of relieving pain in the back and the waist after fracture is solved: 1. after fracture, the trabecula cancellous bone in the vertebral body of a patient is broken and edema causes stimulation of local peripheral nerves, thereby generating pain in the waist and the back. After the bone cement is injected, a large amount of heat can be generated by chemical reaction in the process of setting the bone cement, the highest temperature can reach 60-70 degrees (hands can feel hot), and peripheral nerves of the fracture part can be inactivated by the high temperature, so that the pain of the waist and the back is relieved.

Biomechanical characteristics of thoracic and lumbar stress: 80% of the force of the human body passing through the vertebral body is transmitted downwards through the front 2/3 of the vertebral body, so that the fracture is collapsed better at the front 2/3 of the vertebral body, and the supporting key of the bone cement is also at the front 2/3 of the vertebral body after the operation. In summary, the cement is most desirably located in the anterior 2/3 of the vertebral body in a cylindrical configuration within the vertebral body.

By the method, the technical scheme of the improved mathematical model for calculation is adopted, the uncertainty in the original operation is solved in clinical application, and the success rate of the operation is greatly improved.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; the modifications and the substitutions do not cause the essence of the corresponding technical solutions to depart from the scope of the technical solutions of the embodiments of the present invention, and all the modifications and the substitutions are intended to cover.