CN-122005043-A - Percutaneous vertebral body Combined instrument for forming operation

CN122005043ACN 122005043 ACN122005043 ACN 122005043ACN-122005043-A

Abstract

The invention discloses a percutaneous vertebroplasty combined instrument which comprises an expandable support mesh bag, a hollow opening rod, a directional injection core tube, a rotary driving handle and a rotary driving handle, wherein the expandable support mesh bag is provided with an outer layer mesh bag and an inner layer mesh bag, two ends of the outer layer mesh bag and the inner layer mesh bag are sealed to form an annular filling cavity and a central guide cavity, the distal end of the hollow opening rod is detachably connected with a connector at the proximal end of the expandable support mesh bag, the inner cavity is communicated with the central guide cavity, the directional injection core tube is slidably and rotatably arranged in the hollow opening rod in a penetrating manner, the distal end of the directional injection core tube extends into the central guide cavity and is provided with a radial directional discharge hole, and the rotary driving handle is arranged at the proximal end of the hollow opening rod and is in transmission connection with the directional injection core tube to drive the hollow opening rod to rotate so as to change the direction of the discharge hole. According to the invention, the physical barrier of the bone cement is prevented from leaking through the double-layer structure of the expandable support mesh bag, and the targeted filling is realized through the rotatable directional injection core pipe, so that the problems of high bone cement leakage risk and uncontrollable injection direction in the prior art are solved, and the safety and the accuracy of the operation are improved.

Inventors

LU YIHENG
CHEN YONGBING
FENG YUE

Assignees

苏州名创医疗科技有限公司

Dates

Publication Date: 20260512
Application Date: 20260312

Claims (10)

1. A percutaneous transluminal vertebroplasty combination device, comprising: the expandable support mesh bag comprises a flexible outer layer mesh bag and an inner layer mesh bag, wherein the inner layer mesh bag is sleeved inside the outer layer mesh bag, and two ends of the inner layer mesh bag are in closed connection with the outer layer mesh bag, so that an annular filling cavity is formed between the outer layer mesh bag and the inner layer mesh bag, and a central guide cavity is formed inside the inner layer mesh bag; The distal end of the hollow opening rod is detachably connected with the connector at the proximal end of the expandable support net bag, and the inner cavity of the hollow opening rod is communicated with the central guide cavity; the directional injection core tube is slidably and rotatably arranged in the inner cavity of the hollow opening rod in a penetrating way, the distal end of the directional injection core tube extends into the central guide cavity, and at least one radial directional discharge hole is formed in the wall of the distal end of the directional injection core tube; and the rotary driving handle is fixedly connected with the proximal end of the directional injection core tube and is used for driving the directional injection core tube to rotate so as to change the circumferential direction of the directional discharge hole.
2. The percutaneous vertebroplasty combined instrument of claim 1, wherein the distal end of the directional injection core tube is a closed non-circular driving head, the directional discharge port is arranged adjacent to the non-circular driving head, a feed inlet is formed in the wall of the proximal end of the directional injection core tube, the outer end of the feed inlet is fixedly connected with a feed delivery tube, and the rotary driving handle is provided with an azimuth indication mark, and the direction of the azimuth indication mark corresponds to the direction of the directional discharge port.
3. The percutaneous vertebroplasty combination of claim 1, wherein the distal end of the expandable support mesh bag is fixedly connected with a hollow bone drill bit having a cutting edge and a junk slot, wherein the non-circular drive head of the directional injection core tube is detachably connected to the proximal end of the hollow bone drill bit by a torque transfer structure configured to engage when the directional injection core tube is pushed forward to a limit position to transfer torque generated by the rotary drive handle to the hollow bone drill bit and disengage when the directional injection core tube is retracted rearward.
4. The percutaneous vertebroplasty combined instrument of claim 1, wherein the annular heating wire and the temperature sensor are embedded in the tube wall of the hollow opening rod, and a piezoelectric sensing layer is arranged on the inner wall of the directional injection core tube and used for monitoring the shearing stress of bone cement flowing through the inner cavity of the directional injection core tube so as to calculate the real-time viscosity of the bone cement.
5. The percutaneous vertebroplasty combination device of claim 4, further comprising an external control host, wherein the external control host is electrically connected to the annular heating wire, the temperature sensor, and the piezoelectric sensing layer, respectively; the external control host is configured to: Receiving shear stress data acquired by the piezoelectric sensing layer and converting the shear stress data into a real-time viscosity value of bone cement; when the real-time viscosity value is lower than a preset first threshold value, activating the annular heating wire to heat the bone cement in the hollow expansion rod so as to increase the viscosity; And when the real-time viscosity value is higher than a preset second threshold value, sending out an alarm signal.
6. The percutaneous vertebroplasty combination of claim 5, wherein the external control host is integrally provided with the rotary drive handle, and the rotary drive handle is provided with a display screen for displaying a real-time viscosity value and an adjusting knob for manually adjusting heating power.
7. A percutaneous vertebroplasty combination device in accordance with claim 1, wherein the combination device is configured with two filler materials, a first filler material and a second filler material, respectively; The first filling material is porous bone cement with low elastic modulus and is used for being injected into the annular filling cavity to form a bionic cortical bone structure; The second filling material is high-strength solid bone cement and is used for being injected into the central guide cavity to form the bionic cancellous bone core.
8. The percutaneous vertebroplasty combination of claim 7, wherein the hollow distraction rod further comprises at least one side hole in the wall of the hollow distraction rod, the side hole being in communication with the annular filling lumen, a connecting tube fixedly connected to the outside of the side hole, the side hole being configured to connect a negative pressure suction device to load a drug or bioactive factor into the porous structure of the first filling material injected into the annular filling lumen by negative pressure after the second filling material is injected into the central guide lumen.
9. The percutaneous vertebroplasty combination of claim 1, wherein the expandable support mesh bag is woven from shape memory alloy wires, is compressed and folded in a natural state to fit the puncture sheath, is in a preset ellipsoidal or cylindrical shape in an expanded state, and has a mesh diameter larger than that of the outer mesh bag so as to preferentially penetrate from the central guide cavity to the annular filling cavity when bone cement is injected.
10. A percutaneous vertebroplasty system comprising a percutaneous vertebroplasty combination device as in any one of claims 1 to 9, and a bone cement pusher and a negative pressure suction device for use therewith; The bone cement pushing device is used for being connected with a conveying pipe at the proximal end of the directional injection core pipe; the negative pressure suction device is used for being connected with the connecting pipe of the hollow opening rod; The system realizes drilling, expanding, directional filling and gradient material pouring of the vertebral body through the combined instrument.

Description

Percutaneous vertebral body Combined instrument for forming operation Technical Field The invention belongs to the technical field of medical appliances, and particularly relates to a percutaneous vertebroplasty combined appliance. Background Percutaneous Vertebroplasty (PVP) and Percutaneous Kyphoplasty (PKP) are common minimally invasive techniques for the treatment of osteoporotic vertebral compression fractures, vertebral hemangiomas and metastatic tumors. The basic principle is that bone cement is injected into the pathological change centrum through puncture, so as to achieve the purposes of stabilizing the centrum and relieving pain. In the prior art, PKP procedures typically use balloon dilation to reposition the vertebral body, followed by injection of bone cement at low pressure. However, clinical practice has shown that the existing instruments and methods still have the following technical drawbacks: Firstly, the balloon needs to be withdrawn from the body after being expanded, so that the reset height is partially lost, and the physical barrier is lacking when the bone cement is injected, so that the leakage risk is high. Bone cement is easy to leak to the vertebral canal or the side of the vertebral canal along the vertebral body cortex broken position or the vertebral base venous plexus under the action of pressure, and serious complications such as spinal nerve compression and the like are caused. In the prior art, although the leakage is reduced by adjusting and controlling the viscosity of the bone cement or injecting the bone cement in multiple times, the problem that the flow direction of the bone cement is uncontrollable cannot be fundamentally solved. Secondly, the injection direction of the bone cement cannot be selectively adjusted according to the defect part of the vertebral body. Vertebral compression fractures are mostly asymmetric compression (such as anterior vertebral edge or unilateral collapse), and ideal filling should be preferentially distributed on the severe side of collapse to restore mechanical balance. However, the existing instrument is evenly dispersed when being injected, a doctor cannot realize targeted filling, double-side puncture or multiple times of adjustment are needed, and surgical wounds and radiation exposure are increased. Thirdly, the viscosity of the bone cement dynamically changes along with the polymerization reaction, and a real-time monitoring and regulating means is lacking in the operation. If the viscosity is too low during injection, the leakage risk increases, and if the viscosity is too high, the injection is difficult and dispersion is poor. The doctor completely depends on hand feeling experience to judge the injection time, the operation effect highly depends on the technical level of operators, and the learning curve of a beginner is steep. Fourth, the operation steps are complicated, and multiple instrument exchanges are needed. The traditional PKP needs to sequentially use various instruments such as a puncture needle, a guide wire, an expansion sleeve, a working sleeve, a balloon and the like, so that a puncture path is easy to lose in the exchange process, the operation time is prolonged, and the infection risk and the pain of a patient are increased. Fifthly, the elastic modulus of the existing bone cement filler is far higher than that of human cancellous bone, and stress shielding is easy to occur, so that secondary fracture of adjacent vertebral bodies is caused. Meanwhile, the compact filling structure is not beneficial to bone tissue ingrowth, and biological fixation is difficult to realize. For infectious or neoplastic lesions, the existing apparatus cannot load the filling material with the medicine during operation, and the medicine needs to be administered or otherwise punctured after operation, so that the curative effect is limited. In summary, the existing percutaneous vertebroplasty apparatuses have many defects in terms of anti-seepage performance, directional filling capability, viscosity regulation and control, operation integration level, mechanical bionics, drug loading and the like, and are difficult to meet the requirements of accurate minimally invasive treatment. Accordingly, in view of the above-described problems, it is desirable to provide a percutaneous transluminal vertebroplasty combination device. The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art. Disclosure of Invention The invention aims to provide a percutaneous vertebroplasty combined instrument which can realize the physical barrier leakage prevention of bone cement through a double-layer mesh bag structure and realize targeted filling through a rotatable directional injection core tube. In order t