Vertebral dilation balloon catheter for preventing leakage of bone cement

Abstract

The application discloses a kind of bone cement leakage prevention vertebral body expansion balloon catheter, belong to medical instrument technical field.The bone cement leakage prevention vertebral body expansion balloon catheter includes balloon catheter main part and support wire, the distal end of the inflation balloon body of balloon catheter main part is connected with the distal end of core pipe, the distal end of inflation balloon body is connected with the distal end of outer tube, Y type joint is used to inject contrast medium into inflation balloon body, bag bag is set to the outside of inflation balloon body, bag bag includes distal end absorbable leakage prevention membrane, metal support and proximal end absorbable leakage prevention membrane, metal support is provided with dispersion hole, distal end absorbable leakage prevention membrane and proximal end absorbable leakage prevention membrane are arranged at opposite ends of metal support, the distal end port of distal end absorbable leakage prevention membrane is closed, the proximal end port of proximal end absorbable leakage prevention membrane is provided with absorbable sealing thread, and absorbable sealing thread can be tightly closed bag mouth of bag bag.The application avoids bone cement to occur leakage, and improves the success rate of operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a vertebral body expansion balloon catheter for preventing bone cement leakage. Background Technology

[0002] Percutaneous kyphoplasty (PKP) is a minimally invasive procedure performed under image guidance. A balloon is inserted into the compressed vertebral body to expand and reduce its shape (kyphoplasty), and then bone cement is percutaneously injected into the fractured vertebral body to restore its height, increase its compressive strength, prevent further vertebral collapse and spinal deformity, reduce patient pain, and improve function. Figures 1 to 4 As shown, the surgical procedure involves puncturing the fractured vertebra to create a channel, inflating the balloon (to restore the vertebral height), and injecting bone cement (to increase the strength of the vertebra).

[0003] However, during and after the injection of bone cement, leakage may occur. This leakage can compress nerves, leading to complications such as nerve damage. Currently, traditional surgical tools do not include devices to prevent bone cement leakage.

[0004] Therefore, there is an urgent need to provide a vertebral body expansion balloon catheter that prevents bone cement leakage in order to solve the above problems. Summary of the Invention

[0005] The purpose of this invention is to provide a vertebral body expansion balloon catheter that prevents bone cement leakage, thereby avoiding bone cement leakage and improving the success rate of surgery.

[0006] To achieve the above objectives, the following technical solution is provided:

[0007] A vertebral body expansion balloon catheter for preventing bone cement leakage includes a balloon catheter body and a support wire. The balloon catheter body includes a Y-shaped connector, a sheath, an outer tube, a core tube, an inflatable balloon, and a balloon bag. The distal end of the inflatable balloon is connected to the distal end of the core tube, and the proximal end of the inflatable balloon is connected to the distal end of the outer tube. The Y-shaped connector is used to inject contrast agent into the inflatable balloon. The balloon bag is fitted over the outside of the inflatable balloon. The balloon bag includes a distal absorbable leak-proof membrane, a metal support, and a proximal absorbable leak-proof membrane. The metal support has diffusion holes. The distal and proximal absorbable leak-proof membranes are located at opposite ends of the metal support. The distal port of the distal absorbable leak-proof membrane is closed, and the proximal port of the proximal absorbable leak-proof membrane has an absorbable sealing line that can tightly seal the opening of the balloon bag.

[0008] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, the metal stent is made of shape memory alloy material.

[0009] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, multiple diffusion holes are provided, and the multiple diffusion holes are spaced apart on the metal support.

[0010] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, the diffusion holes have a polygonal structure.

[0011] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, the diffusion hole has an elliptical structure.

[0012] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, the core tube is provided with a radiopaque ring, and the radiopaque ring is located within the expansion balloon.

[0013] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, two contrast rings are provided, with the two contrast rings spaced apart on the core tube.

[0014] As an alternative to the vertebral body expansion balloon catheter for preventing bone cement leakage, a support wire nut is provided at the proximal end of the support wire.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0016] The vertebral body expansion balloon catheter for preventing bone cement leakage provided by this invention has a balloon bag fitted over the outside of the expansion balloon. The balloon bag consists of a distal absorbable leak-proof membrane, a metal support, and a proximal absorbable leak-proof membrane. An absorbable sealing line is provided at the proximal port of the proximal absorbable leak-proof membrane. When the vertebral body expansion balloon catheter expands through the established vertebral body expansion channel, the balloon bag outside the expansion balloon expands along with the expansion balloon. The metal support inside the balloon bag does not rebound after expansion, and the absorbable leak-proof membranes at both ends of the balloon bag expand with the metal support. When the bone cement filler is inserted and bone cement is injected, the distal port (the end further from the operation site) and the distal absorbable leak-proof membrane prevent bone cement from leaking towards the anterior end of the vertebral body, while the proximal absorbable leak-proof membrane prevents bone cement from leaking towards the spinal canal. The absorbable leak-proof membranes at both ends of the metal support ensure that the bone cement diffuses into the cavity within the vertebral body. The metal support acts as a reinforcing rib after the bone cement has diffused, similar to a reinforced concrete structure, which can improve the strength of the injected bone cement. After removing the bone cement filler (and expansion cannula), the absorbable sealing suture is tightened to close the proximal pocket opening, preventing bone cement from leaking into the pedicle canal and compressing the nerve. After locking the leak-proof pocket opening, the excess sealing suture is cut off. The leak-proof membrane and sealing suture remaining in the body can be absorbed, preventing bone cement leakage and improving the success rate of the surgery. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0018] Figure 1 A schematic diagram illustrating the puncture and channel establishment during percutaneous vertebroplasty;

[0019] Figure 2 This is a schematic diagram of balloon inflation during percutaneous vertebroplasty.

[0020] Figure 3 This is a schematic diagram of the cavity formed within the vertebral body during percutaneous vertebroplasty.

[0021] Figure 4 A schematic diagram illustrating the injection of bone cement into the vertebral cavity during percutaneous vertebroplasty.

[0022] Figure 5 This is a schematic diagram of the vertebral body expansion balloon catheter for preventing bone cement leakage in an embodiment of the present invention when the balloon bag is not installed;

[0023] Figure 6 This is a schematic diagram of the structure of the bladder when it is not expanded in an embodiment of the present invention;

[0024] Figure 7 This is a schematic diagram of the structure of the bladder being installed onto the inflatable bladder in an embodiment of the present invention;

[0025] Figure 8 This is a schematic diagram of the structure of the front end of the balloon catheter body in an embodiment of the present invention;

[0026] Figure 9 This is a schematic diagram of the structure of the bladder expanding with the expansion of the inflatable bladder in an embodiment of the present invention;

[0027] Figure 10 This is a schematic diagram of the structure of the first type of metal bracket in an embodiment of the present invention;

[0028] Figure 11 This is a schematic diagram of the structure of the second type of metal bracket in an embodiment of the present invention;

[0029] Figure 12 This is a schematic diagram of the structure of the third type of metal bracket in an embodiment of the present invention;

[0030] Figure 13 This is a schematic diagram of the first loop of absorbable sealing thread in an embodiment of the present invention;

[0031] Figure 14This is a schematic diagram of the absorbable sealing line being tied in a third loop in an embodiment of the present invention;

[0032] Figure 15 This is a schematic diagram of the absorbable sealing line being knotted and tightened in an embodiment of the present invention.

[0033] Figure label:

[0034] 100, support thread; 200, support thread nut;

[0035] 1. Y-type connector; 2. Sheath; 3. Outer tube; 4. Core tube; 5. Expanding bladder; 6. Bladder bag; 7. Imaging ring;

[0036] 61. Distal absorbable leak-proof membrane; 62. Metal support; 63. Proximal absorbable leak-proof membrane; 64. Absorbable sealing line; 65. Diffuse holes. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0038] In the description of this invention, it should be noted that the terms "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0039] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0040] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0041] The steps of PKP surgery are as follows: Step 1: Puncture with a puncture needle, remove the needle shaft; insert a guide wire and remove the outer tube of the puncture needle; insert an expander and remove the guide wire; remove the inner tube of the expander; insert a bone drill to drill a hole; Step 2: Aspirate contrast agent, vacuum the balloon, insert a vertebral body expansion balloon, inflate the balloon, deflate the balloon, and remove the balloon; Step 3: Prepare bone cement, insert a bone cement filler, fill with bone cement, remove the bone cement filler and the outer tube of the expander, and the surgery is complete.

[0042] Currently, during and after the injection of bone cement, leakage may occur. Bone cement leakage can cause nerve compression and lead to complications such as nerve damage.

[0043] To prevent bone cement leakage and improve surgical success rates, this embodiment provides a vertebral body expansion balloon catheter for preventing bone cement leakage. This is an expansion device that can create a cavity in a fractured and collapsed vertebral body. The following is combined with… Figures 5 to 15 The specific content of this embodiment will be described in detail.

[0044] like Figures 5 to 9 As shown, in this embodiment, the vertebral body expansion balloon catheter for preventing bone cement leakage includes a balloon catheter body and a support wire 100. The balloon catheter body includes a Y-type connector 1, a sheath 2, an outer tube 3, a core tube 4, an expansion balloon 5, and a balloon bag 6. The distal end of the expansion balloon 5 is connected to the distal end of the core tube 4, and the proximal end of the expansion balloon 5 is connected to the distal end of the outer tube 3. The Y-type connector 1 is used to inject contrast agent into the expansion balloon 5. The balloon bag 6 is fitted on the outside of the expansion balloon 5. The balloon bag 6 includes a distal absorbable leak-proof membrane 61, a metal support 62, and a proximal absorbable leak-proof membrane 63. The metal support 62 is provided with diffusion holes 65. The distal absorbable leak-proof membrane 61 and the proximal absorbable leak-proof membrane 63 are disposed at opposite ends of the metal bracket 62. The distal port of the distal absorbable leak-proof membrane 61 is closed, and the proximal port of the proximal absorbable leak-proof membrane 63 is provided with an absorbable sealing line 64, which can tightly seal the opening of the bag 6.

[0045] In summary, the vertebral body expansion balloon catheter for preventing bone cement leakage provided by this invention has a balloon bag 6 fitted over the outside of the expansion balloon 5. The balloon bag 6 consists of a distal absorbable leak-proof membrane 61, a metal support 62, and a proximal absorbable leak-proof membrane 63. An absorbable sealing line 64 is provided at the proximal end of the proximal absorbable leak-proof membrane 63. When the vertebral body expansion balloon catheter expands the expansion balloon 5 through the established vertebral body expansion channel, the balloon bag 6 outside the expansion balloon 5 expands together with the expansion balloon 5. The metal support 62 in the balloon bag 6 does not rebound after expansion, and the absorbable leak-proof membranes at both ends of the balloon bag 6 are stretched open with the metal support 62. When bone cement is injected using the bone cement filler, the distal end (the end furthest from the operating site) and the distal absorbable leak-proof membrane 61 prevent bone cement from leaking towards the anterior end of the vertebral body, while the proximal absorbable leak-proof membrane 63 prevents leakage towards the spinal canal. The metal frame 62, with both ends wrapped in absorbable leak-proof membranes, ensures the bone cement diffuses into the vertebral cavity. The metal frame 62 acts as a reinforcing rib after the bone cement has diffused, similar to reinforced concrete, enhancing the strength of the injected bone cement. After removing the bone cement filler (and the expansion cannula), the absorbable sealing line 64 is tightened to close the proximal pouch 6, preventing bone cement from leaking into the pedicle canal and compressing the nerve. After locking the leak-proof pouch, the excess sealing line is cut off. The remaining leak-proof membrane and sealing line can be absorbed by the body, preventing bone cement leakage and improving the success rate of the surgery.

[0046] Furthermore, the metal stent 62 is made of shape memory alloy. The use of shape memory alloy ensures that the metal stent 62 maintains its expanded shape, guaranteeing that the metal stent 62 within the pouch 6 will not spring back after expansion.

[0047] Furthermore, multiple diffusion holes 65 are provided, and these multiple diffusion holes 65 are spaced apart on the metal support 62. By adding multiple diffusion holes 65, it is convenient for the injected bone cement to flow quickly into the vertebral cavity through the diffusion holes 65. The shape of the diffusion holes 65 can be designed according to the actual situation, and no further restrictions are imposed here.

[0048] For example, in some application scenarios, such as Figures 10 to 12 As shown, the diffuser hole 65 has a polygonal structure.

[0049] For example, in some other applications, the diffusion aperture 65 has an elliptical structure.

[0050] Furthermore, the distal absorbable leak-proof membrane 61, the proximal absorbable leak-proof membrane 63, and the absorbable sealing line 64 are made of absorbable polymer materials, which may be, but are not limited to, silk fibroin, polylactic acid, or polyurethane.

[0051] Furthermore, a developing ring 7 is provided on the core tube 4, and the developing ring 7 is located inside the expansion bladder 5. Two developing rings 7 are provided, spaced apart on the core tube 4. The addition of the developing rings 7 facilitates the operator in determining their positions.

[0052] Furthermore, a support wire nut 200 is provided near the end of the support wire 100. The addition of the support wire nut 200 facilitates manual operation.

[0053] The winding method of absorbable sealing line 64 is as follows: Figures 13 to 15 As shown, one end of the sealing line is bent and wrapped around the inside. After wrapping, the sealing line at one end is passed through the sealing line knot loop. At the same time, the sealing line is tightened, and one end of the sealing line tightens the bag opening in the wrapping loop, while the other end of the sealing line ties the wrapping structure, which can close the bag opening of bag 6.

[0054] In summary, the vertebral body expansion balloon catheter for preventing bone cement leakage of this patent adds a pocket 6 outside the expansion balloon 5. The pocket 6 is composed of a shape memory alloy and an absorbable material bag, and the opening of the pocket 6 is threaded with absorbable sutures. After the pocket 6 is expanded by the expansion balloon 5, it remains in the vertebral body. During the operation, after the bone cement is injected, the opening of the pocket is sealed, which can greatly reduce the probability of bone cement leakage during the operation.

[0055] Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims

1. A vertebral body dilation balloon catheter for preventing bone cement leakage, comprising a balloon catheter body and a support wire (100), characterized in that, The balloon catheter body includes a Y-type connector (1), a sheath (2), an outer tube (3), a core tube (4), an inflatable balloon body (5), and a balloon pouch (6). The distal end of the inflatable balloon body (5) is connected to the distal end of the core tube (4), and the proximal end of the inflatable balloon body (5) is connected to the distal end of the outer tube (3). The Y-type connector (1) is used to inject contrast agent into the inflatable balloon body (5). The balloon pouch (6) is fitted over the outside of the inflatable balloon body (5), and the balloon pouch (6) includes a distal absorbable leak-proof membrane (61). A metal support (62) and a proximal absorbable leak-proof membrane (63) are provided. The metal support (62) is provided with diffused holes (65). The distal absorbable leak-proof membrane (61) and the proximal absorbable leak-proof membrane (63) are provided at opposite ends of the metal support (62). The distal port of the distal absorbable leak-proof membrane (61) is closed. The proximal port of the proximal absorbable leak-proof membrane (63) is provided with an absorbable sealing line (64). The absorbable sealing line (64) can tightly seal the opening of the bag (6).

2. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 1, characterized in that, The metal support (62) is made of shape memory alloy material.

3. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 2, characterized in that, Multiple diffusion holes (65) are provided, and the multiple diffusion holes (65) are spaced apart on the metal bracket (62).

4. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 3, characterized in that, The diffused aperture (65) has a polygonal structure.

5. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 3, characterized in that, The diffused pores (65) have an elliptical structure.

6. The vertebral body dilation balloon catheter for preventing bone cement leakage according to any one of claims 3-5, characterized in that, The core tube (4) is provided with a developing ring (7), and the developing ring (7) is located inside the expansion bladder (5).

7. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 6, characterized in that, Two developing rings (7) are provided, and the two developing rings (7) are spaced apart on the core tube (4).

8. The vertebral body dilation balloon catheter for preventing bone cement leakage according to claim 7, characterized in that, The support wire (100) is provided with a support wire nut at its proximal end.

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