An implant system for vertebroplasty leak prevention

Abstract

The present application belongs to the technical field of vertebroplasty medical equipment, and particularly relates to a vertebroplasty anti-leakage implant system, which comprises a delivery catheter, an elastic support, bone cement particles and bone cement. The elastic support is used to support the vertebra after filling the vertebra collapse cavity to form a support framework. The bone cement particles are used to fill the support framework. The bone cement is used to fill the gap between the support framework and the bone cement particles. The present application uses the elastic spring ring to fill the vertebra collapse cavity to form a support framework, then fills the bone cement particles in the support framework, and finally fills the bone cement in the gap between the support framework and the bone cement particles. The system can enhance the vertebroplasty effect, effectively increase the actual filling amount of the bone cement in the vertebra, greatly reduce the bone cement leakage phenomenon, and reduce the tissue damage phenomenon caused by the heat effect of bone cement perfusion.

Description

Technical Field

[0001] This invention belongs to the field of vertebral body shaping medical device technology, specifically relating to a vertebral body shaping anti-leakage implantation system. Background Technology

[0002] Vertebroplasty, also known as percutaneous vertebroplasty (PVP), is a minimally invasive surgery that involves injecting bone cement (polymethyl acrylate, PMMA) or artificial bone into the diseased vertebral body to strengthen it.

[0003] PVP vertebroplasty involves making a small incision (approximately 3mm) in the patient's back, inserting a special needle through the skin under X-ray guidance to create a working channel, and then injecting bone cement or artificial bone into the vertebral body to stabilize the fractured vertebra, prevent further collapse, and significantly relieve pain. However, during PVP vertebroplasty, the bone cement injected into the vertebral body can leak from the fracture, potentially leading to serious consequences such as paraplegia or pulmonary embolism.

[0004] Bone cement is mainly divided into two categories: polymethyl methacrylate cement (PMMA) and calcium phosphate cement (CPC).

[0005] The most commonly used bone cement in clinical practice is PMMA bone cement, a room-temperature self-curing binder composed of powder and liquid components. The powder typically consists of prepolymerized polymethyl methacrylate and an initiator (benzoyl peroxide), and may also include CMC-g-PAA (carboxymethyl cellulose grafted polyacrylic acid), a contrast agent (barium sulfate), and antibiotics (penicillin, erythromycin, gentamicin). The liquid component is usually methyl methacrylate and may also include a crosslinking agent (hydroquinone) or a photoinitiator (N,N-dimethyl-p-toluidine). However, PMMA is a bioinert material and cannot form an organic chemical interface with the host bone tissue. Furthermore, the heat generated during solidification and polymerization, the cytotoxicity of the monomers, and the limited working time also restrict its clinical application. Therefore, in clinical practice, to ensure the bone cement remains in a liquid state during infusion, medical personnel often choose to infuse the fractured vertebral body at a relatively high temperature, leading to varying degrees of damage to the patient's tissues caused by the high-temperature bone cement.

[0006] To overcome the shortcomings of bone cement and better benefit patients, doctors and technicians are making improvements in several ways. These include refining the material formulation and improving replacement techniques. For example, using a specialized bone cement gun and placing a decompression tube can reduce complications and improve safety. Another approach is to add an appropriate proportion of bone granules to the bone cement; as these granules are absorbed, the body's bone tissue gradually grows into the cement, achieving self-fixation and preventing loosening.

[0007] The improved PKP vertebroplasty, which incorporates lessons learned from PVP, involves balloon dilation followed by staged injection of bone cement. This process compacts the cancellous bone around the cavity left after balloon dilation, creating an artificial barrier to prevent bone cement leakage. Furthermore, the use of a push rod for staged injection significantly reduces the pressure during bone cement injection compared to continuous injection with a pressure pump, thus greatly reducing bone cement leakage.

[0008] Both PVP and PKP vertebroplasty have undeniable advantages, such as reliable and highly effective pain relief. However, they also have drawbacks. For instance, the pain relief mechanism of PVP and PKP vertebroplasty may involve the anchoring of bone cement within the fractured vertebra, fixing microfractures in osteoporotic vertebrae, increasing vertebral stability, and thus reducing stimulation of pain nerve endings within the vertebra. Alternatively, the exothermic and toxic effects of the bone cement polymerization reaction may damage nerve endings and inflammatory pain-inducing factors within the vertebra, altering the vertebral microenvironment, reducing pain sensitivity, and blocking the generation of pain mediators, thereby achieving an analgesic effect. In these processes, the issue of bone cement leakage also warrants attention. Summary of the Invention

[0009] To address the problems and shortcomings of the existing technology, the present invention provides a vertebral body shaping and anti-leakage implantation system.

[0010] To achieve the above objectives, the present invention provides the following technical solution:

[0011] A leak-proof implantation system for vertebroplasty includes:

[0012] The delivery catheter has a hollow tubular structure and is used to introduce elastic support, bone cement particles and bone cement from the outside. The delivery catheter is located in a tunnel drilled by hand on the fractured thoracic vertebral body, which is accessible to the balloon. One end is used to connect to the vertebral body collapse cavity inside the vertebral body, and the other end extends to the outside of the vertebral body.

[0013] The elastic support component, after being implanted into the vertebral body collapse cavity, is used to fill the vertebral body collapse cavity and form a support skeleton to support the vertebral body.

[0014] Bone cement granules are spherical granules made from bone cement and are used for the first filling of the supporting skeleton.

[0015] Bone cement is used to fill the gaps between the supporting framework and the bone cement particles.

[0016] Furthermore, the elastic support is an embolized spring coil in the shape of a spiral three-dimensional frame. The surface of the embolized spring coil is covered with cilia. The embolized spring coil is introduced into the delivery conduit through a tubular embolized spring coil delivery device and enters the vertebral collapse cavity.

[0017] Furthermore, the diameter of the delivery conduit is larger than the diameter of the embolized spring coil delivery device.

[0018] Furthermore, the bone cement is drawn into the bone cement syringe and then injected into the vertebral collapse cavity through a delivery catheter.

[0019] Furthermore, the bone cement particles and bone cement are drawn into the bone cement injector and then injected through a delivery catheter.

[0020] Furthermore, after inserting the embolization spring coil pushing device into the delivery conduit, the embolization spring coil is pushed into the vertebral collapse cavity.

[0021] Furthermore, the embolization spring coil is made of platinum-tungsten alloy.

[0022] Compared with the prior art, the beneficial effects of the present invention are:

[0023] Advantage 1: This invention uses embolized spring coils to fill the vertebral body collapse cavity, forming a supporting skeleton to support the vertebral body collapse cavity. This is more effective than the previous method of using bone cement alone to support the vertebral body collapse cavity. It can effectively compress the cancellous bone around the vertebral body collapse cavity and create favorable conditions for bone cement injection. The embolized spring coils are covered with cilia, which can prevent the bone cement from leaking out.

[0024] Advantage 2: This invention uses bone cement particles to fill the support framework formed by the embolized spring coils. The bone cement particles release a large amount of heat when they are made in the external environment, and the average polymerization temperature of the bone cement can reach 64°C. The prepared bone cement particles are introduced into the vertebral body collapse cavity through a delivery catheter, which minimizes the damage to the vertebral nerves caused by the exothermic reaction of bone cement polymerization when bone cement is directly injected into the vertebral body collapse cavity in the past. It does not cause irreversible thermal damage to the tissues around the vertebral body collapse cavity and reduces the thermal effect generated during bone cement polymerization.

[0025] Advantage 3: This invention employs a method of filling the collapsed vertebral body cavity with embolized spring coils to form a support framework, followed by filling the support framework with bone cement granules, and finally filling the gaps between the support framework and the bone cement granules with bone cement. This effectively increases the actual amount of bone cement filling the vertebral body, significantly reducing bone cement leakage and tissue damage caused by the thermal effects of bone cement infusion. The vertebral body shaping and anti-leakage implantation system described in this invention also has advantages such as simple manufacturing process, convenient usage, and wide applicability.

[0026] Advantage 4: The present invention uses an embolized spring coil as a support component, including a mesh tube woven from polymer filaments and a spiral support skeleton made of platinum-tungsten alloy passing through the mesh tube. The polymer material can further block the cracks on the vertebral body and prevent leakage during the injection of bone cement. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of the present invention;

[0028] Figure 2 This is a schematic diagram of the tubular embolized spring coil delivery device for pushing embolized spring coils according to the present invention.

[0029] Figure 3 for Figure 2 Schematic diagram of the structure of the embolization spring coil;

[0030] Figure 4 for Figure 3 A schematic diagram showing the embolization spring coils being delivered to the vertebral collapse cavity and unfolded.

[0031] Figure 5 This is a schematic diagram of a conveyor structure used to push bone cement and bone cement particles.

[0032] In the diagram: 1. Delivery catheter, 2. Vertebral body, 3. Vertebral body collapse cavity, 4. Elastic support, 5. Bone cement particles, 6. Bone cement. Detailed Implementation

[0033] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0034] like Figure 1As shown, a vertebral body reconstruction and leak-proof implantation system includes: a delivery catheter 1, which has a hollow tubular structure, for introducing an elastic support 4, bone cement particles 5, and bone cement 6 from the outside. The delivery catheter 1 is located in a tunnel drilled by hand on the fractured thoracic vertebral body 2, which allows a balloon to pass through. One end is used to connect to the vertebral body collapse cavity 3 inside the vertebral body 2, and the other end extends to the outside of the vertebral body 2. The elastic support 4 is an embolized spring coil. The embolized spring coil is introduced into the delivery catheter 1 through a tubular embolized spring coil delivery device and enters the vertebral body collapse cavity 3. After the embolized spring coil is implanted into the vertebral body collapse cavity 3, it is used to fill the vertebral body collapse cavity 3 to form a supporting skeleton to support the vertebral body 2. The bone cement particles 5 are drawn into the bone cement syringe and injected into the supporting skeleton inside the vertebral body collapse cavity 3 through the delivery catheter 1 for the first filling. Then, the bone cement 6 is drawn into the bone cement syringe to fill the gap between the supporting skeleton and the bone cement particles 5 for the second filling.

[0035] like Figure 3 As shown, the embolization spring coil used in this invention has a spiral three-dimensional frame structure. Before use, the embolization spring coil is placed in a position such as... Figure 2 In the embolization spring coil delivery device shown, the embolization spring coil includes a mesh tube woven from polymer filaments and a spiral support skeleton made of shape memory alloy metal core wire passing through the mesh tube. The metal core wire material is nickel-titanium alloy, platinum, platinum-iridium alloy, platinum-tungsten alloy, tungsten, iridium, or titanium alloy. Secondly, the polymer is nylon, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, or block polyamide, and cilia are distributed on the surface of the polymer. Finally, bone cement 6 is polymethyl methacrylate bone cement, which is composed of bone cement powder and liquid. The bone cement powder and liquid are mixed before injection and set aside. Bone cement granules 5 are spherical granules formed by stirring and granulating the bone cement powder and liquid of bone cement 6 and set aside.

[0036] In practical use, this invention first expands the collapsed vertebral cavity 3 using a balloon. After expansion, the balloon is removed, and a delivery catheter 1 is inserted... Figure 2 The embolization spring coil delivery device shown pushes the embolization spring coil into the vertebral body collapse cavity 3. After filling the vertebral body collapse cavity 3, the embolization spring coil forms a supporting skeleton to support the vertebral body 2. Then, the prepared bone cement particles 5 are passed through... Figure 4 The bone cement syringe shown is inserted into the delivery catheter 1 and delivers bone cement particles into the vertebral body collapse cavity 3 to fill the supporting skeleton. Finally, bone cement 6 is injected into the vertebral body collapse cavity 3 through the delivery catheter 1 to fill the gap between the supporting skeleton and the bone cement particles 5. After filling, the delivery catheter 1 is removed and the hole left after the delivery catheter 1 is removed is filled to complete the entire process.

Claims

1. A leak-proof implantation system for vertebral body shaping, characterized in that, include: The delivery catheter (1) has a hollow tubular structure and is used to introduce elastic support (4), bone cement particles (5) and bone cement (6) from the outside. The delivery catheter (1) is located in a tunnel drilled by hand on the fractured vertebral body (2) that allows the balloon to pass through. One end is used to connect to the vertebral body collapse cavity (3) inside the vertebral body (2), and the other end extends to the outside of the vertebral body (2). Elastic support member (4), after being implanted into the vertebral body collapse cavity (3), is used to fill the vertebral body collapse cavity (3) to form a support skeleton to support the vertebral body (2); Bone cement particles (5) are spherical granules made from bone cement (6) as raw material, used for the first filling of the supporting skeleton; Bone cement (6) is used to fill the gap between the supporting skeleton and bone cement particles (5) for the second time. The structure of the elastic support (4) is an embolized spring coil and is in the shape of a spiral three-dimensional frame. The surface of the embolized spring coil is covered with cilia. The diameter of the delivery conduit (1) is larger than the diameter of the embolized spring coil delivery device. The vertebral body collapse cavity (3) is filled with the bone cement particles (5) and bone cement (6) injected through the delivery conduit (1) after being drawn in by the bone cement syringe. An embolized spring coil is provided in the vertebral body collapse cavity (3). In use, the embolized spring coil is pushed into the vertebral body collapse cavity (3) by the delivery conduit (1) with the embolized spring coil pusher inserted inside. The embolized spring coil is made of platinum-tungsten alloy.

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