All-in-one targeted kyphoplasty system

Abstract

The invention discloses an integrated targeted vertebral kyphoplasty system, comprising a puncture head, a tube body and a tube body handle; one end of the tube body is connected to the puncture head, a balloon is arranged on the end of the tube body connected to the puncture head, and a guide is arranged on the tube body at one end of the balloon; the other end of the tube body is connected to the tube body handle, and a guide knob for controlling the bending of the guide and a pressure pump connector for communicating with the balloon are arranged on the end of the tube body connected to the tube body handle; a cement outlet is arranged on the puncture head, a cement channel is arranged at the center of the tube body, a cement inlet is arranged on the tube body handle, and the cement outlet, the cement channel and the cement inlet are connected. The device only needs one puncture and can complete the entire KP surgical treatment without changing any tools, which greatly reduces the patient's intraoperative radiation exposure rate and the pain caused by multiple operations.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an integrated targeted vertebral kyphoplasty system. Background Art

[0002] Osteoporosis is the most common bone metabolic disease affecting the world. With the acceleration of aging, the disease is very common. The most common result of spinal osteoporosis is vertebral compression fracture. With the aging of the population, the incidence of osteoporotic vertebral compression fracture (OVCF) is shockingly high. Patients with severe pain often require minimally invasive vertebroplasty or kyphoplasty for treatment, both of which have achieved good therapeutic effects in clinical practice. Among them, kyphoplasty (KP) is a new technology based on vertebroplasty combined with balloon reduction. Compared with vertebroplasty, it has the advantages of low risk of bone cement leakage, better recovery of vertebral height, and better improvement of spinal curvature, and is more widely used in clinical practice.

[0003] KP can use bilateral pedicle approach or unilateral pedicle approach in specific surgical operations. The unilateral approach saves half of the surgical time and surgical trauma of the bilateral approach, and the clinical efficacy is equivalent to that of the bilateral approach, which is more advantageous. However, there are several shortcomings in the current clinical unilateral approach for KP: ①. Due to the limitations of current operating tools, surgical techniques, and the timing of bone cement injection, some patients often need to switch to a bilateral surgical approach when the bone cement distribution is poor during unilateral surgery; ②. The flow direction of bone cement in the vertebral body is uncontrollable, and it is impossible to accurately achieve targeted injection of bone cement. At the same time, due to the uncontrollability of bone cement flow, although bone cement leakage is less than vertebroplasty, it still occurs from time to time; ③. The surgical operating tools are relatively cumbersome. After the puncture needle is used, the working channel needs to be replaced. After the working channel is well placed, a balloon needs to be placed. After the balloon is repositioned, the balloon needs to be removed and a bone cement injection device needs to be installed. Such repeated operations increase the number of X-ray exposures of patients. At the same time, since KP is often performed under local anesthesia, multiple tool changes increase the number of times patients suffer pain, and the intraoperative experience is poor. Summary of the invention

[0004] In order to avoid the many shortcomings and deficiencies of the current KP mentioned above, the present invention proposes an integrated targeted vertebral kyphoplasty system, which can complete the entire KP surgical treatment with only one puncture and without changing any tools, greatly reducing the patient's intraoperative radiation exposure rate and the pain caused by multiple operations.

[0005] In order to achieve the above object, the present invention adopts the following technical scheme:

[0006] An integrated targeted vertebral kyphoplasty system comprises a puncture head, a tube body and a tube body handle;

[0007] One end of the tube body is connected to the puncture head, a balloon is arranged on the end of the tube body connected to the puncture head, and a guide is arranged on the tube body at one end of the balloon;

[0008] The other end of the tube body is connected to the tube body handle, and the end of the tube body connected to the tube body handle is provided with a guide knob for controlling the bending of the guide and a pressure pump connector for communicating with the balloon;

[0009] The puncture head is provided with a cement outlet, the center of the tube body is provided with a cement channel, the tube body handle is provided with a cement inlet, and the cement outlet, the cement channel and the cement inlet are connected.

[0010] The cement outlet is arranged on one side of the puncture head.

[0011] An annular groove is arranged on the end of the tube body, and the balloon is arranged in the annular groove.

[0012] The tube body is provided with an annular medium channel along the axial direction, and the medium channel connects the balloon and the power pump joint.

[0013] A pressure sensor is also arranged on the pipe body, a pressure pump connector is arranged on one side of the pressure sensor, and the medium channel is communicated with both the pressure sensor and the pressure pump connector.

[0014] The guide comprises a soft spring arranged inside the tube body and a plurality of arc grooves arranged on the outer wall of the tube body; a traction rope is arranged axially on the tube body, and the soft spring is connected with the guide knob through the traction rope.

[0015] The two traction ropes are symmetrically arranged, and the two traction ropes are respectively connected to the two direction control ends of the guide knob.

[0016] The utility model also comprises a push rod, which comprises a thin rod and a push rod handle connected with the thin rod, and the thin rod can be inserted into the cement channel.

[0017] Compared with the prior art, the present invention has the following beneficial technical effects:

[0018] The integrated targeted vertebral kyphoplasty system of the present invention is equipped with a push direction guide, and the bone cement push site can be changed within the vertebral body to the target position desired by the operator, so as to achieve targeted injection of bone cement at the fracture site and reduce the bone cement leakage rate. Since the bone cement push site can be changed within the vertebral body to the position desired by the operator, the operator can place the bone cement push site on the opposite side of the puncture to push the bone cement, which can easily complete the bilateral distribution of bone cement and avoid the necessity of bilateral approach. The targeted vertebral kyphoplasty system is an integrated design, and the cost is lower than that of current surgical instruments. It is believed that it will have better medical and economic value in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a stereoscopic diagram of the integrated targeted vertebral kyphoplasty system of the present invention;

[0020] Figure 2 This is a front view of the integrated targeted vertebral kyphoplasty system of the present invention;

[0021] Figure 3 yes Figure 2 A cross-sectional view of

[0022] Figure 4 yes Figure 3 Enlarged view of point A in the middle;

[0023] Figure 5 This is a diagram showing the use status of the integrated targeted vertebral kyphoplasty system of the present invention;

[0024] Figure 6 yes Figure 2 Schematic diagram of the push rod in .

[0025] Among them, 1 is the cement outlet; 2 is the puncture head; 3 is the balloon; 4 is the guide; 5 is the tube body; 6 is the pressure sensor; 7 is the pressure pump connector; 8 is the tube body handle; 9 is the push rod; 10 is the guide knob; 11 is the medium channel; 12 is the traction rope; 13 is the cement channel; 14 is the thin rod; 15 is the push rod handle; 16 is the soft spring; 17 is the cement inlet. DETAILED DESCRIPTION

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0027] In order to make the purpose, technical solutions and advantages of the present invention more clear, the specific implementation of the present invention is further described below in conjunction with the accompanying drawings and embodiments, which are intended to explain the present invention rather than limit it.

[0028] like Figures 1 to 6 As shown, the integrated targeted vertebral kyphoplasty system of the present invention comprises a puncture head 2, a tube body 5 and a tube body handle 8;

[0029] One end of the tube body 5 is connected to the puncture head 2, a balloon 3 is arranged on the end of the tube body 5 connected to the puncture head 2, and a guide 4 is arranged on the tube body 5 at one end of the balloon 3; the guide 4 can be bent in both directions, and the bending angle is 0~90°.

[0030] The other end of the tube body 5 is connected to the tube body handle 8. The end of the tube body 5 connected to the tube body handle 8 is provided with a guide knob 10 for controlling the bending of the guide 4 and a pressure pump connector 7 for communicating with the balloon 3. The guide knob 10 can be rotated clockwise or counterclockwise to control the bending of the guide 4, thereby driving the puncture head 2 and the balloon 3 to change direction. The pressure pump connector 7 is used to connect to the balloon syringe.

[0031] The puncture head 2 is provided with a cement outlet 1, the center of the tube body 5 is provided with a cement channel 13, and the tube body handle 8 is provided with a cement inlet 17. The cement outlet 1 and the cement channel 13 are connected with the cement inlet 17. The cement inlet 17 is used to connect with a bone cement injector. Rapid injection of bone cement through the cement channel 13 can be used to position the bone cement in the vertebral body.

[0032] Wherein, the cement outlet 1 is arranged on one side of the puncture head 2, so that single-side cement injection can be achieved.

[0033] The end of the tube 5 is provided with an annular groove, and the balloon 3 is arranged in the annular groove. When the balloon 3 is expanded, it expands outwards according to the outer contour of the annular groove, and effectively expands and reduces the vertebral fracture site.

[0034] The tube body 5 is provided with an annular medium channel 11 along the axial direction, and the medium channel 11 connects the balloon 3 and the pressure pump connector 7. Through the annular medium channel 11, the balloon is targeted to expand and reduce the fracture site after being filled with contrast agent.

[0035] The tube body 5 is also provided with a pressure sensor 6 , a pressure pump connector 7 is provided on one side of the pressure sensor 6 , and the medium channel 11 is communicated with both the pressure sensor 6 and the pressure pump connector 7 .

[0036] like Figure 4As shown, the guide 4 includes a soft spring 16 arranged inside the tube body 5 and a plurality of arc grooves arranged on the outer wall of the tube body 5; the tube body 5 is provided with a traction rope 12 along the axial direction, and the soft spring 16 is connected to the guide knob 10 through the traction rope 12. The soft spring 16 is bent to one side under the pulling of the traction rope 12, thereby generating a torque at the front end of the tube body, and due to the plurality of arc grooves on the outer wall of the tube body 5, the outer wall of the tube body 5 is bent under the action of the torque to form a bendable end.

[0037] When the guide knob 10 rotates one circle, the guide 4 is bent by 90°. The bending angle of the guide 4 is controlled by rotating the guide knob 10, thereby realizing the injection of cement in different directions.

[0038] In order to achieve bidirectional bending, the traction ropes 12 are two symmetrically arranged, and the two traction ropes are respectively connected to the two direction control ends of the guide knob 10.

[0039] The push rod 9 includes a thin rod 14 and a push rod handle 15 connected to the thin rod 14, and the thin rod 14 can be inserted into the cement channel 13. The push rod 9 realizes manual feeding of cement in the cement channel.

[0040] like Figure 5 As shown, the method of using the integrated targeted vertebral kyphoplasty system of the present invention is as follows:

[0041] 1. Insert the puncture head 2 into the vertebral body requiring surgery, establish the working channel by controlling the tube handle 8, and when peripheral expansion is required, adjust the guide knob 10 to bend the guide 4.

[0042] 2. After balloon 3 is targeted and placed at the compression site of the fracture, the balloon is filled with contrast agent to perform fracture dilation and reduction.

[0043] 3. Then the contrast agent in the balloon is emptied and bone cement is filled. The bone cement inlet 17 is connected to the bone cement injector, and the configured bone cement is injected to control the distribution of bone cement in the vertebral body. The flow direction of bone cement in the vertebral body is controlled by the guide, and the targeted injection of bone cement is accurately achieved. At the same time, due to the controllability of bone cement flow, the problem of bone cement leakage is effectively solved.

[0044] The integrated targeted vertebral kyphoplasty system of the present invention has the following advantages:

[0045] 1. Improve the efficiency of unilateral puncture and reduce the operation time;

[0046] 2. Directed through the vertebral midline area;

[0047] 3. There is no damage to the medial wall of the pedicle;

[0048] 4. Reduce the number of intraoperative radiographic fluoroscopy;

[0049] 5. Reduce iatrogenic radiation damage.

[0050] 6. Create arc-shaped cavity to reduce cancellous bone destruction;

[0051] 7. Increase the inlay connection between bone cement and cancellous bone;

[0052] 8. Bone cement is more evenly distributed, reducing the probability of re-fracture;

[0053] 9. Has the same clinical effect in relieving pain;

[0054] 10. Reduce surgical costs;

[0055] 11. Reduce postoperative pain and the incidence of subcutaneous hematoma caused by puncture;

[0056] 12. Reduce the pain and discomfort of patients during surgery and improve their tolerance to surgery;

[0057] 13. Targeted fracture distraction reduction, more accurate reduction and better efficacy;

[0058] 14. Targeted injection of bone cement makes the injection controllable and the distribution better, reducing the probability of bone cement leakage.

[0059] The above embodiments are only for explaining the implementation of the present invention, so that professionals in the field can implement or use the present invention, and the description is not limiting. Therefore, the present invention will not be limited to the embodiments shown herein, and all additions and equivalent replacements made according to the technical features of the present invention belong to the protection scope of this application.

Claims

1. An integrated targeted vertebral kyphoplasty system, characterized in that: It comprises a puncture head (2), a tube body (5) and a tube body handle (8); One end of the tube body (5) is connected to the puncture head (2), a balloon (3) is provided on the end of the tube body (5) connected to the puncture head (2), and a guide (4) is provided on the tube body (5) at one end of the balloon (3); The other end of the tube body (5) is connected to the tube body handle (8), and the end of the tube body (5) connected to the tube body handle (8) is provided with a guide knob (10) for controlling the bending of the guide (4) and a pressure pump connector (7) for communicating with the balloon (3); The puncture head (2) is provided with a cement outlet (1), the center of the tube body (5) is provided with a cement channel (13), the tube body handle (8) is provided with a cement inlet (17), and the cement outlet (1), the cement channel (13) and the cement inlet (17) are connected; The tube body (5) is provided with an annular medium channel (11) along the axial direction, and the medium channel (11) is connected to the balloon (3) and the pressure pump connector (7); The tube body (5) is also provided with a pressure sensor (6), a pressure pump connector (7) is provided on one side of the pressure sensor (6), and the medium channel (11) is connected to both the pressure sensor (6) and the pressure pump connector (7); The guide (4) comprises a soft spring (16) arranged inside the tube body (5) and a plurality of arc-shaped grooves arranged on the outer wall of the tube body (5); a traction rope (12) is arranged axially on the tube body (5), and the soft spring (16) is connected to the guide knob (10) via the traction rope (12); The cement outlet (1) is arranged on one side of the puncture head (2); An annular groove is provided on the end of the tube body (5), and the balloon (3) is arranged in the annular groove; When the balloon (3) is inflated, it expands outwards according to the outer contour of the annular groove; The targeted vertebral kyphoplasty system is an integrated design; when peripheral expansion is required, the guide knob (10) is adjusted to bend the guide (4); a contrast agent-filled balloon (3) is used to expand the balloon; the contrast agent in the balloon is emptied and bone cement is filled.

2. The integrated targeted vertebral kyphoplasty system according to claim 1, characterized in that: The traction ropes (12) are two symmetrically arranged, and the two traction ropes are respectively connected to the two direction control ends of the guide knob (10).

3. The integrated targeted kyphoplasty system according to claim 1, characterized in that: It also comprises a push rod (9), wherein the push rod (9) comprises a thin rod (14) and a push rod handle (15) connected to the thin rod (14), and the thin rod (14) can be inserted into the cement channel (13).

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