WO2020103711A1

WO2020103711A1 - Multifunctional vertebroplasty instrument

Info

Publication number: WO2020103711A1
Application number: PCT/CN2019/116829
Authority: WO
Inventors: 李东; 李磊; 胡冬; 张鹏云; 吕世文
Original assignee: 宁波华科润生物科技有限公司
Priority date: 2018-11-20
Filing date: 2019-11-08
Publication date: 2020-05-28
Also published as: CN109745114A

Abstract

A multifunctional vertebroplasty instrument, comprising a balloon assembly (1) and a cavity opening assembly (2); the cavity opening assembly (2) comprises an outer tube assembly (21) and a cavity opening liner assembly (22); the outer tube assembly (21) comprises an outer tube (211) and an outer tube handle (212); the outer tube (211) has axial stiffness that enables said tube to withstand tissue cavity opening thrust without deformation; the outer tube handle (212) is provided with a bone filler injection port (2120); the cavity opening liner assembly (22) comprises an end closure (221), a connecting member (222), and a connecting member handle (223); the maximum outer diameter of the end enclosure (221) is less than or equal to the inner diameter of the outer tube (211); the distal end portion of the balloon assembly (1) is inserted into the outer tube assembly (21) along the connecting member (222). The other multifunctional vertebroplasty instrument differs from the above multifunctional vertebroplasty instrument in that: the distal end of the outer tube (211) is provided with a side hole (2110), the cavity opening lining assembly (22) comprises an end enclosure (221) and a connecting member (222), and the maximum outer diameter of the end enclosure (221) is greater than the inner diameter of the outer tube (211). The two multifunctional vertebroplasty instruments implement the integration of cavity opening, expansion, and bone filler injection, and are easy and flexible to operate, thereby shortening the operation time and reducing the operation risk.

Description

Multifunctional vertebral body shaping instrument

Technical field

The invention belongs to the technical field of medical instruments, and in particular relates to a multifunctional vertebral shaping instrument used in vertebroplasty.

Background technique

Osteoporotic vertebral compression fractures are a common disease that endangers the health of middle-aged and elderly people. For vertebral compression fractures, traditional treatment methods are mainly conservative, including bed rest, medical pain relief, and external fixation of braces. The further loss of bone mass exacerbates osteoporosis, resulting in a vicious cycle; and open surgery is often due to the patient's poor general health and insufficient screw fixation strength, which can easily lead to internal fixation failure.

French doctor Deramond et al. Reported in 1987 that percutaneous vertebroplasty (PVP) was used to treat aggressive hemangioma of the C2 vertebral body and achieved good results. Since then, the technology has also been applied to vertebral malignant tumors and osteoporosis. The disadvantage of this operation is that it can only fix the injured vertebrae and relieve pain, cannot restore the height of the vertebral body and correct the deformity of the kyphosis, and due to the direct injection of low viscosity into the vertebral cancellous bone under higher pressure It is difficult to control the flow of bone cement, and the leakage rate of bone cement is high, which is reported to be 30% to 67% in the literature. By 1994, based on PVP, American scholar Reiley et al. Designed a technique for correcting kyphosis through balloon dilatation, which became balloon dilatation kyphoplasty (PKP), which was approved by the FDA in 1998 for application clinical. This technique uses a percutaneous puncture to place an inflatable balloon into the collapsed vertebral body. The expansion of the balloon lifts the endplate, restores the height of the vertebral body, corrects the kyphosis, and forms a bone around the vertebral body. The cavity of the shell is filled with high-viscosity bone cement at a lower pressure. In order for the balloon to enter the vertebral body smoothly, it is necessary to establish a working channel with a puncture needle and a working sleeve, and then use a bone drill to drill the working cavity channel of the balloon before expansion, and then send the balloon into the vertebral body. After forming a cavity surrounded by a bone shell in the vertebral body, the balloon is withdrawn, and finally bone cement is injected. The operation steps are cumbersome; at the same time, due to the structure of the vertebral body, in order to maintain the balance of the mechanical force of the vertebral body, each Both vertebral bodies require bilateral balloon dilation and bone cement injection. Surgery needs to be operated under X-ray monitoring. The more cumbersome the operation, the longer the damage to the doctor ’s health and the higher the physical requirements. Bilateral balloon dilation and bone cement injection are trauma to patients and high chances of complications. It also increases the economic burden of patients. The above-mentioned shortcomings become more prominent in the case of multi-segment vertebral body lesions.

In view of the above shortcomings, the Chinese patent with the patent number 201310671713.6 discloses a vertebral balloon expansion system, which is designed with a rigid head to protect the balloon sleeve and liner core. Before the expansion of the working channel, the distal end of the balloon is fixedly connected with a closed head. First, the head of this technology is set at the distal end of the balloon. The part where the distal end of the balloon and the head are connected involves the ball. The sealing problem of balloon expansion has a certain risk of leakage when the balloon is expanded. Secondly, this technology only realizes the open channel and expansion before expansion, does not achieve the filling function of bone filler, and does not achieve the largest reduction. The financial burden of the patient.

In response to the problems in the prior art, there is an urgent need for a multifunctional vertebral body shaping instrument that is flexible in use, simple in operation, can shorten the operation time, reduce the operation risk, reduce the economic burden on patients, open the cavity, expand the balloon, and deliver the filler.

Summary of the invention

The technical problem to be solved by the present invention is to propose a multifunctional vertebral body shaping instrument integrating the establishment of a cavity, expansion and delivery of bone fillers in view of the above-mentioned defects in the prior art.

To achieve the above objectives, the present invention adopts the following technical solutions:

The first technical solution of the present invention is to provide a multifunctional vertebroplasty instrument including a balloon component and a cavity-opening component. The cavity-opening component includes an outer tube component and a cavity-opening lining component, wherein:

The outer tube assembly includes an outer tube and an outer tube handle, the outer tube handle is disposed at a proximal end of the outer tube, the outer tube has an axial rigidity to withstand tissue open cavity thrust without deformation, the outer tube handle Equipped with bone filler injection interface;

The open cavity liner assembly includes a head, a connector, and a connector handle. The head is disposed at a distal end of the connector. The maximum outer diameter of the head is less than or equal to the inner diameter of the outer tube. The handle of the connecting piece is arranged at the proximal end of the connecting piece;

The distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and by operating the outer tube handle, the outer tube can be moved back and forth along the axis of the balloon assembly After the balloon assembly and the open cavity liner assembly are withdrawn from the outer tube assembly, bone filler is injected through the bone filler injection interface to achieve vertebral body filling.

The second technical solution of the present invention is to provide a multifunctional vertebroplasty instrument, which includes a balloon component and a cavity-opening component. The cavity-opening component includes an outer tube component and a cavity-opening lining component, wherein:

The outer tube assembly includes an outer tube and an outer tube handle. The outer tube handle is disposed at a proximal end of the outer tube. The outer tube has an axial rigidity that does not deform under the thrust of the tissue opening cavity. The outer tube The distal end is provided with a side hole, and the outer tube handle is provided with a bone filler injection interface;

The open cavity liner assembly includes a head and a connector, the head is disposed at a distal end of the connector, and the maximum outer diameter of the head is larger than the inner diameter of the outer tube;

The distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and by operating the outer tube handle, the outer tube can be moved back and forth along the axis of the balloon assembly After the balloon component is withdrawn from the outer tube component, bone filler is injected through the bone filler injection interface to achieve vertebral body filling.

Further, in the first and second technical solutions, the distal end of the outer tube is a fixed bending section or an adjustable bending section, and the distal end of the connecting member cooperates with the distal end of the outer tube.

Further, in the first and second technical solutions, the balloon assembly includes a balloon body, a developing ring, an inner balloon tube, an outer balloon tube, and a balloon handle, and the balloon body is made of a single layer of polymer material Made of or made of an outer layer mesh bag and an inner layer polymer material balloon, the distal end of the balloon body is fixedly connected to the balloon inner tube, and the proximal end of the balloon body is outside the balloon The distal end of the tube is fixedly connected, the proximal end of the outer tube of the balloon is fixedly connected to the balloon handle, and a passage is formed between the inner tube of the balloon and the outer tube of the balloon.

Further, in the first technical solution, the connector handle and the balloon handle have an integrated structure.

Further, in the first and second technical solutions, the outer tube handle is detachably connected to the balloon handle or the connector handle.

Further, in the first technical solution, the connecting member is an inner balloon tube of the balloon assembly, and a distal end of the inner balloon tube extends beyond the distal end of the balloon body and is connected to the head.

Further, in the second technical solution, the outer tube is provided with one or more side holes.

Further, in the second technical solution, the outer tube handle is provided with a hole along the axial direction of the outer tube.

Further, in the second technical solution, the proximal end of the connecting member is detachably connected to the hole.

The present invention adopts the above technical solution, and compared with the prior art, has the following technical effects:

1) In the existing vertebroplasty surgery, in order to make the vertebral body have better mechanical properties after surgery, each vertebral body needs to be bilaterally punctured / established a cavity, bilateral expansion and bilateral filling; and The distal end of the multifunctional vertebral body shaping instrument of the present invention can be a fixed bending section or an adjustable bending section, and the distal end of the instrument can be sent to the center of the vertebral body or the opposite side of the vertebral body. Effectively reduce the patient's trauma, reduce the operation time, reduce the occurrence of complications, and reduce the patient's financial burden;

2) In the existing vertebroplasty surgery, each vertebral body needs to establish a working channel with a puncture needle, and then use a bone drill to establish a cavity in the vertebral body, then withdraw the bone drill, and then send the balloon into the vertebral body Expand and expand the vertebral body to form a cavity, and finally withdraw the balloon and inject bone cement; and the multifunctional vertebral body shaping instrument of the present invention can achieve multiple functions with only one instrument, that is, it can be The working channel establishes a cavity in the vertebral body, then expands, and finally delivers the bone filler from the bone filler injection port on the outer tube handle under a low pressure environment. burden;

3) The sealing head designed by the present invention is fixedly connected to the distal end of the connecting member, which effectively reduces the risk that the connection between the sealing head and the distal end of the balloon may cause insufficient sealing during expansion;

4) The balloon designed by the present invention is made of an outer mesh bag and an inner polymer balloon, this design increases the pressure resistance of the entire balloon and increases the safety of the operation;

5) The multifunctional vertebral body shaping instrument of the present invention realizes the integration of cavity opening, expansion and injection of bone filler, and the operation is simple and flexible, shortening the operation time and reducing the operation risk.

BRIEF DESCRIPTION

FIG. 1 is a schematic structural diagram of a first embodiment of the present invention;

FIG. 1a is a schematic diagram of the enlarged structure of the balloon assembly and area B of the first embodiment;

FIG. 1b is a schematic structural view of the cavity-opening assembly of the first embodiment;

FIG. 1c is a schematic diagram of the distal structure of the instrument of the first embodiment;

FIG. 1d is a schematic structural view of the first embodiment of the present invention for establishing a cavity in a vertebral body;

FIG. 1e is a schematic diagram of the structure of the balloon released by the withdrawal tube of the first embodiment;

FIG. 1f is a schematic structural view of the balloon expansion and expansion of the vertebral body of the first embodiment;

FIG. 1g is a schematic structural view of the balloon assembly and the open cavity liner assembly withdrawn from the outer tube assembly of the first embodiment;

FIG. 1h is a schematic structural view of the first embodiment for transporting bone filler along an outer tube;

2 is a schematic structural diagram of a second embodiment of the present invention;

2a is an enlarged schematic structural view of a balloon assembly, an open cavity liner assembly, and area B of the second embodiment;

2b is a schematic structural diagram of an outer tube assembly of the second embodiment;

2c is a schematic diagram of the distal structure of the instrument of the second embodiment;

2d is a schematic structural view of the second embodiment of the present invention for establishing a cavity in the vertebral body;

FIG. 2e is a schematic diagram of the structure of the balloon released by the retracted delivery tube of the second embodiment;

FIG. 2f is a schematic structural view of the balloon expansion and expansion of the vertebral body of the second embodiment;

2g is a schematic structural view of the balloon assembly and the open cavity liner assembly withdrawn from the outer tube assembly of the second embodiment;

FIG. 2h is a schematic structural view of the second embodiment for transporting bone filler along the outer tube;

3 is a schematic structural diagram of a third embodiment of the present invention;

FIG. 3a is a schematic diagram of an enlarged structure of a balloon assembly and area B of the third embodiment;

FIG. 3b is a schematic structural view of the cavity-opening assembly of the third embodiment;

FIG. 3c is a schematic diagram of the distal structure of the instrument according to the third embodiment;

3d is a schematic structural view of the third embodiment of the present invention for establishing a lumen in the vertebral body;

FIG. 3e is a schematic diagram of the structure of the release balloon of the third embodiment to release the balloon;

FIG. 3f is a schematic structural view of the balloon expansion and expansion of the vertebral body of the third embodiment;

3g is a schematic structural view of the balloon assembly withdrawn from the outer tube assembly of the third embodiment;

Fig. 3h is a schematic structural view of the third embodiment for transporting bone filler along the outer tube and the side hole

4 is a schematic structural diagram of a fourth embodiment of the present invention;

4a is a schematic diagram of an enlarged structure of a balloon assembly and area B of the fourth embodiment;

4b is a schematic diagram of the structure of the cavity-opening assembly of the fourth embodiment;

4c is a schematic diagram of the distal structure of the instrument according to the fourth embodiment;

4d is a schematic structural view of the fourth embodiment of the present invention to establish a cavity without bending in the vertebral body;

FIG. 4e is a schematic diagram of the structure of the balloon released by the withdrawal tube of the fourth embodiment;

FIG. 4f is a schematic structural view of the balloon expansion and expansion of the vertebral body of the fourth embodiment;

4g is a schematic structural view of the balloon assembly withdrawn from the outer tube assembly of the fourth embodiment;

FIG. 4h is a schematic structural view of the fourth embodiment for delivering bone filler along the outer tube and the side hole;

5 is a schematic structural diagram of a fifth embodiment of the present invention;

5a is a schematic structural diagram of a balloon assembly of a fifth embodiment;

FIG. 5b is a schematic structural view of an open cavity assembly of the fifth embodiment;

5c is a schematic diagram of the distal structure of the fifth embodiment of the instrument;

5d is a schematic structural view of a fifth embodiment of the present invention for establishing a lumen in a vertebral body;

FIG. 5e is a schematic diagram of the structure of the balloon withdrawn from the fifth embodiment to release the balloon;

FIG. 5f is a schematic structural view of the balloon expansion and expansion of the vertebral body of the fifth embodiment;

5g is a schematic structural view of the balloon assembly and the open cavity liner assembly withdrawn from the outer tube assembly of the fifth embodiment;

FIG. 5h is a schematic structural view of a fifth embodiment for transporting bone filler along an outer tube;

Among them, the reference signs are as follows:

1-balloon assembly, 11-balloon body, 111-mesh bag, 112-balloon, 12-developing ring, 13-balloon inner tube, 14-balloon outer tube, 15-balloon handle, 16-balloon Pathway between inner tube and balloon outer tube, 17-gas or liquid, 2-open cavity assembly, 21-outer tube assembly, 22-open cavity inner liner assembly, 211-outer tube, 2110-side hole, 212-outer tube Handle, 2120-bone filler injection interface, 2121-hole, 221-head, 222-connector, 223-connector handle, 23-filler, 3-working channel.

detailed description

In the following, the present invention will be described in detail and concretely through specific embodiments, so as to better understand the present invention, but the following embodiments do not limit the scope of the present invention.

Example 1

As shown in FIG. 1, a multifunctional vertebroplasty instrument is characterized by comprising a balloon assembly 1 and a cavity-opening assembly 2. In this embodiment, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.

As shown in FIG. 1a, the balloon assembly 1 includes a balloon body 11, a developing ring 12, a balloon inner tube 13, a balloon outer tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material The distal end of the balloon body 11 is fixedly connected to the balloon inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, and the proximal end of the balloon outer tube 14 is The end is fixedly connected to the balloon handle 15, the distal end of the inner tube 13 is a curved section, and the proximal end is a straight section. Between the inner tube 13 and the outer tube 14 is a passage 16, which can be The gas or liquid 17 is injected into the capsule 11 through the passage 16.

As shown in FIG. 1b, the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, the cavity opening lining assembly 22 includes a head 221, The connecting piece 222 and the connecting piece handle 223, the outer tube 211 has a rigidity to withstand the tissue cavity pushing force without deformation, the sealing head 221 is fixedly connected to the distal end of the connecting piece 222, the maximum outer diameter of the sealing head 221 Less than or equal to the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed curved section, the outer tube 211 is made of memory alloy material or metal material or a combination of both materials, The outer tube handle 212 is provided with a bone filler injection interface 2120. By operating the outer tube handle 212, the outer tube 211 can be moved back and forth along the axis of the balloon assembly 1. The outer tube handle 212 and the balloon The handle 15 is detachably connected.

As shown in FIG. 1c, the balloon 11 is disposed inside the outer tube 211, the head 221 can slide inside the outer tube 211, the outer tube 211, the balloon inner tube 13 and the The distal curved section of the connecting member 221 cooperates, and the distal end portion of the balloon assembly 1 is inserted along the connecting member 222 and installed inside the outer tube assembly 21.

The specific surgical procedure is as follows:

As shown in FIG. 1d, the multifunctional vertebral body shaping instrument is inserted into the vertebral body along the working channel 3 and observed under fluoroscopy until the head 221 passes over the center of the vertebral body, reaches the opposite side of the vertebral body, and the cavity is established.

As shown in FIG. 1e, the outer tube handle 212 is adjusted, and the outer tube 211 is withdrawn until the balloon 11 is completely exposed.

As shown in FIG. 1f, the gas or liquid 17 is injected into the capsule 11 along the passage 16 to expand and expand the vertebral body.

As shown in FIG. 1g, the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 and the open cavity liner assembly 22 are withdrawn from the outer tube assembly 21, at this time the interior of the vertebral body Leave a cavity.

As shown in FIG. 1h, the filler 23 is delivered into the vertebral body along the bone filler injection interface 2120 and the outer tube 211 until the filler 23 fills the internal cavity of the vertebral body, and all instruments are withdrawn, completing surgery.

Example 2

As shown in FIG. 2, a multifunctional vertebral body shaping instrument is characterized by comprising a balloon assembly 1 and a cavity-opening assembly 2. In this embodiment, the proximal end refers to the end close to the operator, and the distal end refers to the end away from the operator.

As shown in FIG. 2a, the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material The distal end of the balloon body 11 is fixedly connected to the balloon inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, and the proximal end of the balloon outer tube 14 is The end is fixedly connected to the balloon handle 15, the distal end of the inner tube 13 is a curved section, and the proximal end is a straight section. Between the inner tube 13 and the outer tube 14 is a passage 16, which can be A gas or liquid 17 is injected into the balloon body 11 through the passage 16, the balloon inner tube 13 of the balloon assembly 1 is the connecting piece 222, and the distal end of the balloon inner tube 13 extends out of the balloon body 11 The distal end is connected to the head 221, and the balloon handle 15 and the connector handle 223 are of an integrated structure.

As shown in FIG. 2b, the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, the cavity opening lining assembly 22 includes a head 221, The connecting piece 222 and the connecting piece handle 223, the outer tube 211 has a rigidity to withstand the thrust of tissue opening without deformation, the maximum outer diameter of the head 221 is less than or equal to the inner diameter of the outer tube 211, the outer The distal end of the tube 211 is a fixed curved section or an adjustable curved section. The outer tube 211 is made of a memory alloy material or a metal material or a combination of the two. The outer tube handle is provided with 212 The bone filler is injected into the interface 2120, and the outer tube 211 can be moved forward and backward along the balloon assembly 1 by operating the outer tube handle 212.

As shown in FIG. 2c, the balloon 11 is disposed inside the outer tube 211, and the head 221 can slide inside the outer tube 211. The distal portion of the balloon assembly 1 is inserted into the outer tube assembly 21 along the connecting member 222.

The specific surgical procedure is as follows:

As shown in FIG. 2d, the multifunctional vertebral body shaping instrument is inserted into the vertebral body along the working channel 3 and observed under fluoroscopy until the head 221 passes over the center of the vertebral body, reaches the opposite side of the vertebral body, and the cavity is established.

As shown in FIG. 2e, the outer tube handle 212 is adjusted, and the outer tube 211 is withdrawn until the balloon 11 is completely exposed.

As shown in FIG. 2f, the gas or liquid 17 is injected into the capsule 11 along the passage 16, expanding and expanding the vertebral body.

As shown in FIG. 2g, the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 and the open cavity liner assembly 22 are withdrawn from the outer tube assembly 21, at this time the interior of the vertebral body Leave a cavity.

As shown in FIG. 2h, the filler 23 is delivered into the vertebral body along the bone filler injection interface 2120 and the outer tube 211 until the filler 23 fills the internal cavity of the vertebral body, and all instruments are withdrawn, completing surgery.

Example 3

As shown in FIG. 3, a multifunctional vertebroplasty instrument is characterized by comprising a balloon assembly 1 and a cavity-opening assembly 2. In this embodiment, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.

As shown in FIG. 3a, the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material The distal end of the balloon body 11 is fixedly connected to the balloon inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, and the proximal end of the balloon outer tube 14 is The end is fixedly connected to the balloon handle 15, the distal end of the inner tube 13 of the balloon is a curved section, and the proximal end is a straight section. Between the inner tube 13 of the balloon and the outer tube 14 of the balloon is a passage 16, which can be The gas or liquid 17 is injected into the capsule 11 through the passage 16.

As shown in FIG. 3b, the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, and the cavity opening lining assembly 22 includes a head 221 and The connecting piece 222, the outer tube 211 has a rigidity to withstand the thrust of tissue opening without deformation, the head 221 is fixedly connected to the distal end of the connecting piece 222, the outer tube 211 is made of memory alloy material or metal material Made of a combination of the two materials, the maximum outer diameter of the head 221 is greater than the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed bending section or an adjustable bending section, so The distal end of the outer tube 211 is provided with one or more side holes 2110, the outer tube 211 is made of a memory alloy material, the outer tube handle is provided 212 with a bone filler injection interface 2120, the outer tube handle 212 A hole 2121 along the axial direction of the outer tube is provided on the outer tube. The outer tube 211 can be moved back and forth along the axis of the balloon assembly 1 by operating the outer tube handle 212. The outer tube handle 212 and the balloon handle 15 is a detachable connection.

As shown in FIG. 3c, the balloon body 11 is disposed inside the outer tube 211, the outer tube 211, the balloon inner tube 13 and the distal curved section of the connecting member 221 cooperate, the ball The distal portion of the bladder assembly 1 is inserted into the outer tube assembly 21 along the connecting member 222.

The specific surgical procedure is as follows:

As shown in FIG. 3d, the multifunctional vertebral body shaping instrument is inserted into the vertebral body along the working channel 3 and observed under fluoroscopy until the head 221 passes over the center of the vertebral body, reaches the opposite side of the vertebral body, and the cavity is established.

As shown in FIG. 3e, the outer tube handle 212 is adjusted, and the outer tube 211 is withdrawn until the balloon 11 is completely exposed.

As shown in FIG. 3f, gas or liquid 17 is injected into the capsule 11 along the passage 16, expanding and expanding the vertebral body.

As shown in FIG. 3g, the inflation gas or liquid is withdrawn along the passage 16, and then the balloon body 11 is retracted into the outer tube 211, and then the balloon assembly 1 is withdrawn from the outer tube assembly 21. At this time, a cavity is left inside the vertebral body.

As shown in FIG. 3h, the outer tube handle 212 is operated to make the side hole 2110 enter the cavity, and the proximal end of the connecting member 222 is operated to insert the proximal end of the connecting member into the hole groove 2121 to make the connection The piece 222 is connected and fixed with the outer tube handle 212, along the bone filler injection interface 2120 and the outer tube 211, the bone filler 23 is delivered into the vertebral body through the side hole 2110 until the bone filler 23 is filled Fill the cavity inside the vertebral body, withdraw all the instruments and complete the operation.

Example 4

As shown in FIG. 4, a multifunctional vertebral body shaping instrument is characterized by comprising a balloon assembly 1 and a cavity-opening assembly 2. In this embodiment, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.

As shown in FIG. 4a, the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the balloon body 11 is made of a single layer of polymer material The distal end of the balloon body 11 is fixedly connected to the balloon inner tube 13, the proximal end of the balloon body 11 is fixedly connected to the distal end of the balloon outer tube 14, and the proximal end of the balloon outer tube 14 is And the balloon handle 15 are fixedly connected, the distal end and the proximal end of the balloon inner tube 13 are straight sections, and the passage 16 between the balloon inner tube 13 and the balloon outer tube 14 can pass through The passage 16 injects gas or liquid 17 into the capsule 11.

As shown in FIG. 4b, the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, and the cavity opening lining assembly 22 includes a head 221 and Connecting piece 222, the outer tube 211 has a rigidity to withstand the thrust of tissue opening without deformation, the sealing head 221 is fixedly connected to the distal end of the connecting piece 222, the maximum outer diameter of the sealing head 221 is greater than the outer tube The inner diameter of 211, the distal end of the outer tube 211 is an adjustable angle section, the distal end of the outer tube 211 is provided with one or more side holes 2110, the outer tube 211 is made of memory alloy material or metal Made of materials or a combination of both. The outer tube handle 212 is provided with a bone filler injection port 2120. The outer tube handle 212 is provided with a hole 2121 along the axial direction of the outer tube. The outer tube handle 212 enables the outer tube 211 to move back and forth along the axis of the balloon assembly 1.

As shown in FIG. 4c, the balloon body 11 is disposed inside the outer tube 211, and the distal end portion of the balloon assembly 1 is inserted into the outer tube assembly 21 and installed along the connecting member 222.

The specific surgical procedure is as follows:

As shown in FIG. 4d, the multifunctional vertebral body shaping instrument is inserted into the vertebral body along the working channel 3 and observed under fluoroscopy until the head 221 passes over the center of the vertebral body to complete the establishment of the cavity.

As shown in FIG. 4e, adjust the outer tube handle 212, and then withdraw the outer tube 211 until the balloon 11 is completely exposed.

As shown in FIG. 4f, gas or liquid 17 is injected into the bladder 11 along the passage 16 to expand and expand the vertebral body.

As shown in FIG. 4g, the inflation gas or liquid is withdrawn along the passage 16, and then the balloon body 11 is retracted into the outer tube 211, and then the balloon assembly 1 is withdrawn from the outer tube In the assembly 21, a cavity is left inside the vertebral body.

As shown in FIG. 4h, the outer tube handle 212 is operated to allow the side hole 2110 to enter the cavity, and the proximal end of the connector 222 is operated to insert the proximal end of the connector into the hole slot 2121 to make the connection The piece 222 is connected and fixed with the outer tube handle 212, along the bone filler injection interface 2120 and the outer tube 211, the bone filler 23 is delivered into the vertebral body through the side hole 2110 until the bone filler 23 is filled Fill the cavity inside the vertebral body, withdraw all the instruments and complete the operation.

Example 5

As shown in FIG. 5, a multifunctional vertebral body shaping instrument is characterized by comprising a balloon assembly 1 and a cavity-opening assembly 2.

As shown in FIG. 5a, the balloon assembly 1 includes a balloon body 11, a developing ring 12, an inner balloon tube 13, an outer balloon tube 14, and a balloon handle 15, the distal end of the balloon body 11 and the balloon The inner tube 13 is fixedly connected, and the proximal end of the balloon 11 is fixedly connected to the distal end of the balloon outer tube 14, when the balloon 11 is expanded, as shown in FIG. 5a (1) (FIG. 5a (2) It is a schematic diagram of the bladder made of a single layer of polymer material and expanded), the bladder 11 is made of an outer mesh bag 111 and an inner polymer material balloon 112, and the outer tube 14 of the balloon The proximal end of the tube is fixedly connected to the balloon handle 15, the distal end of the inner tube 13 of the balloon is a curved section, and the proximal end is a straight section, and a passage 16 is provided between the inner tube 13 of the balloon and the outer tube 14 of the balloon The gas or liquid 17 can be injected into the capsule 11 through the passage 16.

As shown in FIG. 5b, the cavity opening assembly 2 includes an outer tube assembly 21 and a cavity opening lining assembly 22, the outer tube assembly includes an outer tube 211 and an outer tube handle 212, the cavity opening lining assembly 22 includes a head 221, The connecting piece 222 and the connecting piece handle 223, the outer tube 211 has a rigidity to withstand the tissue cavity pushing force without deformation, the sealing head 221 is fixedly connected to the distal end of the connecting piece 222, the maximum outer diameter of the sealing head 221 Less than or equal to the inner diameter of the outer tube 211, the distal end of the outer tube 211 is a fixed curved section, the outer tube 211 is made of memory alloy material or metal material or a combination of both materials, The outer tube handle 212 is provided with a bone filler injection interface 2120. By operating the outer tube handle 212, the outer tube 211 can be moved back and forth along the axis of the balloon assembly 1. The outer tube handle 212 and the balloon The handle 15 is detachably connected.

As shown in FIG. 5c, the balloon 11 is disposed inside the outer tube 211, the head 221 can slide inside the outer tube 211, the outer tube 211, the balloon inner tube 13 and all The distal curved section of the connecting member 222 cooperates, and the distal end portion of the balloon assembly 1 is inserted along the connecting member 222 and installed inside the outer tube assembly 21.

The specific surgical procedure is as follows:

As shown in FIG. 5d, the multifunctional vertebral body shaping instrument is inserted into the vertebral body along the working channel 3 and observed under fluoroscopy until the head 221 passes over the center of the vertebral body, reaches the opposite side of the vertebral body, and the cavity is established.

As shown in FIG. 5e, the outer tube handle 212 is adjusted, and the outer tube 211 is withdrawn until the capsule 11 is completely exposed.

As shown in FIG. 5f, the gas or liquid 17 is injected into the capsule 11 along the passage 16 to expand and expand the vertebral body.

As shown in FIG. 5g, the inflation gas or liquid is withdrawn along the passage 16, and then the balloon assembly 1 and the open cavity liner assembly 22 are withdrawn from the outer tube assembly 21, at this time, the interior of the vertebral body Leave a cavity.

As shown in FIG. 5h, the filler 23 is delivered into the vertebral body along the bone filler injection interface 2120 and the outer tube 211 until the filler 23 fills the internal cavity of the vertebral body, all instruments are withdrawn, and completed surgery.

The specific embodiments of the present invention have been described in detail above, but they are only used as examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

A multifunctional vertebroplasty instrument, characterized by comprising a balloon assembly and a cavity-opening assembly, the cavity-opening assembly includes an outer tube assembly and an cavity-opening lining assembly, wherein:

The outer tube assembly includes an outer tube and an outer tube handle, the outer tube handle is disposed at a proximal end of the outer tube, the outer tube has an axial rigidity to withstand tissue open cavity thrust without deformation, the outer tube handle Equipped with bone filler injection interface;

The open cavity liner assembly includes a head, a connector, and a connector handle. The head is disposed at a distal end of the connector. The maximum outer diameter of the head is less than or equal to the inner diameter of the outer tube. The handle of the connecting piece is arranged at the proximal end of the connecting piece;

The distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and by operating the outer tube handle, the outer tube can be moved back and forth along the axis of the balloon assembly After the balloon assembly and the open cavity liner assembly are withdrawn from the outer tube assembly, bone filler is injected through the bone filler injection interface to achieve vertebral body filling.
A multifunctional vertebroplasty instrument, characterized by comprising a balloon assembly and a cavity-opening assembly, the cavity-opening assembly includes an outer tube assembly and an cavity-opening lining assembly, wherein:

The outer tube assembly includes an outer tube and an outer tube handle. The outer tube handle is disposed at a proximal end of the outer tube. The outer tube has an axial rigidity that does not deform under the thrust of the tissue opening cavity. The outer tube The distal end is provided with a side hole, and the outer tube handle is provided with a bone filler injection interface;

The open cavity liner assembly includes a head and a connector, the head is disposed at a distal end of the connector, and the maximum outer diameter of the head is larger than the inner diameter of the outer tube;

The distal portion of the balloon assembly is inserted into the outer tube assembly along the connector, and by operating the outer tube handle, the outer tube can be moved back and forth along the axis of the balloon assembly After the balloon component is withdrawn from the outer tube component, bone filler is injected through the bone filler injection interface to achieve vertebral body filling.
The multifunctional vertebroplasty instrument according to claim 1 or 2, wherein the distal end of the outer tube is a fixed bending section or an adjustable bending section, and the distal end of the connecting member and the outer tube To match the far end.
The multifunctional vertebroplasty device according to claim 1 or 2, wherein the balloon assembly includes a balloon, a developing ring, an inner balloon tube, an outer balloon tube, and a balloon handle, and the balloon body It is made of a single layer of polymer material or a combination of an outer layer mesh bag and an inner layer polymer material balloon. The distal end of the balloon body is fixedly connected to the balloon inner tube, and the proximal end of the balloon body It is fixedly connected to the distal end of the outer balloon tube, the proximal end of the outer balloon tube is fixedly connected to the balloon handle, and a passage is formed between the inner balloon tube and the outer balloon tube.
The multifunctional vertebral body shaping instrument according to claim 4, wherein the connector handle and the balloon handle have an integrated structure.
The multifunctional vertebroplasty instrument according to claim 4, wherein the outer tube handle is detachably connected to the balloon handle or the connector handle.
The multifunctional vertebroplasty instrument according to claim 1, wherein the connecting member is an inner balloon tube of the balloon assembly, and the distal end of the inner balloon tube extends beyond the distal end of the balloon body Connect with the head.
The multifunctional vertebroplasty instrument according to claim 2, wherein the outer tube is provided with one or more side holes.
The multifunctional vertebroplasty instrument according to claim 2, wherein the outer tube handle is provided with a hole along the axial direction of the outer tube.
The multifunctional vertebroplasty instrument according to claim 9, wherein the proximal end of the connecting member is detachably connected to the hole.