A photodynamic bone stabilization balloon and system

Abstract

The application discloses a kind of photodynamic bone stable balloon and system, belong to medical instrument technical field, including outer balloon and inner balloon;Between outer balloon and inner balloon, there is injection liquid outer cavity;Injection liquid outer cavity is used to inject the photosensitive liquid containing initiator;Inner balloon has operating inner cavity, and operating inner cavity is used to make optical fiber enter;Optical fiber is used to transmit light energy, to activate initiator to initiate photosensitive liquid polymerization;Outer balloon has non-compliant balloon section and compliant balloon section in axial direction, at least one non-compliant balloon section is used to correspond the fracture crack in medullary cavity, and compliant balloon section is used to adaptive expansion at the variable diameter area in medullary cavity, solve the contradiction of " over-compliance leads to uncontrolled expansion, bone injury " and " insufficient compliance leads to poor fit, axial sliding ".

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a photodynamic bone stabilization balloon and system. Background Technology

[0002] In orthopedic clinics, pathological fractures or impending fractures caused by cancer bone metastases are common and challenging conditions. Traditional treatments often involve internal fixation with metal implants (such as intramedullary nails or plate-screw systems). However, metal implants present problems such as significant trauma, bleeding, and long recovery periods. Furthermore, they can produce noticeable artifacts during postoperative radiotherapy or CT / MRI follow-up examinations, interfering with imaging diagnosis.

[0003] In recent years, the Photodynamic Bone Stabilization System (PBSS) has gradually gained attention as a minimally invasive technique. This technology delivers a photosensitive monomer liquid to the bone lesion area via an injectable balloon, which then solidifies in situ after blue light irradiation, forming an internal support scaffold. It offers advantages such as minimal trauma, less bleeding, and good image compatibility. However, PBSS faces a key technical bottleneck in practical applications: the matching between the mechanical properties of the balloon and the irregular geometry of the bone medullary cavity. The medullary cavity of bones (especially irregular bones such as the pelvis, scapula, and vertebrae) is not a regular cylinder or cone shape, but rather contains areas of varying diameters, uneven bone walls, and irregular cavities caused by tumor erosion. The balloon needs to achieve three functions in this complex environment: adhering tightly to the bone wall to prevent monomer leakage; providing sufficient axial and radial support; and forming a stable lock with the bone wall after solidification to prevent slippage.

[0004] However, existing balloons have significant drawbacks: If the balloon has excessive inflation capacity, it will expand and deform without limit under pressure. When the bone cortex is weakened due to tumor erosion or there are local defects, the over-inflated balloon is prone to bulging excessively in the direction of the defect, and may even break through the bone cortex and enter the soft tissue, causing iatrogenic injury. In addition, over-inflation can cause secondary bone damage due to the balloon.

[0005] If the balloon's deformability is limited, it can only have a fixed expansion shape under rated pressure. When there are irregular diameter-changing areas within the medullary cavity, it is difficult for the balloon to adaptively fill the uneven structure, resulting in gaps or poor local contact between the balloon and the bone wall. This prevents the solidified balloon from forming sufficient mechanical interlocking force with the bone, making it prone to slippage or displacement under axial load, leading to internal fixation failure. On the other hand, poor local contact can cause stress concentration, increasing the risk of balloon rupture and monomer leakage.

[0006] In summary, the balloons used in existing PBSS technology generally present a contradiction when dealing with irregularly shaped areas within the bone medullary cavity: insufficient compliance leading to poor fit and axial slippage, versus excessive compliance leading to uncontrolled expansion and bone damage. Therefore, there is an urgent need to develop a novel balloon structure or material design that can achieve both adaptive fit within irregular medullary cavities and effectively limit excessive expansion, thereby providing stable and reliable intraosseous support while ensuring safety. Summary of the Invention

[0007] The purpose of this invention is to solve the above-mentioned technical problems and provide a photodynamic bone stabilization balloon and system. The photodynamic bone stabilization balloon has a non-compliant balloon segment and a compliant balloon segment in the axial direction. The compliant balloon segment with limited deformability is used for the corresponding intramedullary fracture crack, while the compliant balloon segment with stronger deformability is used for adaptive expansion in the diameter change area of ​​the intramedullary cavity. This solves the contradiction between "excessive compliance leading to uncontrolled expansion and bone damage" and "insufficient compliance leading to poor fit and axial slippage".

[0008] To achieve the above objectives, the present invention provides the following solution: The present invention discloses a photodynamic bone stabilization balloon, comprising an outer balloon and an inner balloon; the outer balloon encloses and fixes the inner balloon, and a fluid-filled external cavity is formed between the outer balloon and the inner balloon; the fluid-filled external cavity is used to inject a photosensitive liquid containing an initiator to inflate the outer balloon; the inner balloon has an operating cavity for transmitting optical fiber to activate the initiator and initiate a polymerization reaction of the photosensitive liquid; the outer balloon has a non-compliant balloon segment and a compliant balloon segment in the axial direction, at least one of the non-compliant balloon segments is used for the intramedullary fracture fissure, and the compliant balloon segment is used for the intramedullary diameter change region.

[0009] In one embodiment, the non-compliant balloon segment is located in the middle in the axial direction, and the compliant balloon segment is located at both ends in the axial direction.

[0010] In one embodiment, the external balloon is a single balloon.

[0011] In one embodiment, the external balloon is a multi-sac, with the sac in the middle being a non-compliant balloon segment and the sacs at both ends being compliant balloon segments.

[0012] In one embodiment, the outer wall of the external balloon is provided with a plurality of connecting grooves along the circumference, the connecting grooves extending axially to the distal and proximal ends of the external balloon to connect the bone marrow on the proximal and distal sides of the medullary cavity.

[0013] In one embodiment, the outer wall of the outer balloon is coated with a drug-release layer for releasing functional drugs.

[0014] In one embodiment, the operating cavity can also be circulated with a cooling medium, which is used for circulating cooling and generating internal pressure on the photosensitive liquid in the injection cavity.

[0015] This invention also discloses a photodynamic bone stabilization system, comprising a catheter, an optical fiber, a photosensitive liquid, and the aforementioned photodynamic bone stabilization balloon; the proximal end of the catheter is detachably connected to the distal end of the photodynamic bone stabilization balloon to deliver the balloon; the catheter is provided with an injection channel and an instrument channel; the injection channel communicates with the external injection cavity of the photodynamic bone stabilization balloon for injecting the photosensitive liquid; the instrument channel communicates with the internal operating cavity of the photodynamic bone stabilization balloon for delivering the optical fiber.

[0016] In one embodiment, an adapter is further included, which is connected to the proximal end of the catheter. The adapter is provided with a vacuum port, a liquid injection port, and an optical fiber port. The vacuum port is connected to the liquid injection channel and is used to evacuate the liquid injection outer cavity. The liquid injection port is connected to the liquid injection channel and is used to inject and re-evacuate the photosensitive liquid into the liquid injection outer cavity. The optical fiber port is connected to the instrument channel and is used to deliver the optical fiber into the operating cavity.

[0017] In one embodiment, the catheter is further provided with a cooling channel, which is connected to the operating cavity of the photodynamic bone stabilization balloon for injecting a cooling medium; the adapter is further provided with a coolant interface, which is connected to the cooling channel for circulating and injecting a cooling medium into the operating cavity.

[0018] In one embodiment, the air extraction port is provided with a one-way valve to prevent gas backflow.

[0019] In one embodiment, the injection port is equipped with a pressure gauge for monitoring the injection pressure.

[0020] In one embodiment, the device further includes a monitoring ring and a traction rod. The monitoring ring is fixed to the traction rod, which is rigid in the axial direction and flexible in the radial direction. The traction rod can deliver the monitoring ring into the operating cavity through an optical fiber interface and an instrument channel, and pull the monitoring ring out of the operating cavity when the photosensitive liquid polymerization reaction is completed. The outer wall of the monitoring ring is used to fit against the inner wall of the operating cavity, and a pressure sensor is provided on the outer wall of the monitoring ring.

[0021] In one embodiment, a temperature sensor is also provided on the outer wall of the monitoring ring.

[0022] In one embodiment, a developing material is added to the monitoring ring or a developing agent is added to the photosensitive liquid to cooperate with the developing equipment to locate the position of the photodynamic bone stabilization balloon.

[0023] In one embodiment, the optical fiber includes a transparent sleeve and multiple optical fibers, the multiple optical fibers being disposed inside the transparent sleeve; each optical fiber is divided into a light-emitting segment and a light-shielding segment in the axial direction, the light-emitting segment being located at the far end of the optical fiber; the light-emitting segments of the multiple optical fibers are arranged in a staggered manner from far to near in the axial direction to form several independently light-emitting sections in the axial direction of the transparent sleeve; each optical fiber is independently connected to a lighting control console.

[0024] In one embodiment, the light-emitting parts of the transparent sleeve are separated by a light-blocking plate to prevent the multiple light-guiding fibers from crossing each other in the axial direction.

[0025] In one embodiment, the photosensitive liquid comprises at least one multifunctional methacrylate monomer.

[0026] The present invention achieves the following technical effects compared to the prior art: In this invention, the photodynamic bone stabilization balloon has a non-compliant balloon segment and a compliant balloon segment in the axial direction. At least one compliant balloon segment is used to correspond to the fracture crack in the medullary cavity to avoid "over-compliance leading to uncontrolled expansion and bone damage". The compliant balloon segment is used for adaptive expansion in the variable diameter area in the medullary cavity to solve the problem of "insufficient compliance leading to poor fit and axial slippage". This forms a photodynamic bone stabilization balloon that can achieve adaptive fit in irregular medullary cavities and effectively limit excessive expansion, thereby providing stable and reliable intraosseous support while ensuring safety. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained by analyzing these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the photodynamic bone stabilization system in an embodiment of the present invention; Figure 2 This is a three-dimensional structural diagram of the photodynamic bone stabilization balloon (single balloon) in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the photodynamic bone stabilization balloon (single capsule) in an embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the photodynamic bone stabilization balloon (single balloon) after expansion within the medullary cavity in an embodiment of the present invention; Figure 5This is a three-dimensional structural diagram of the photodynamic bone stabilization balloon (multi-cyst body) in an embodiment of the present invention; Figure 6 This is a schematic diagram of the structure of the photodynamic bone stabilization balloon (multi-cyst) in an embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of the photodynamic bone stabilization balloon (multi-cyst) after expansion within the medullary cavity in an embodiment of the present invention; Figure 8 This is a schematic diagram of the structure of the photodynamic bone stabilizing balloon (with an external drug-releasing layer) in an embodiment of the present invention; Figure 9 This is a schematic diagram of the structure of the photodynamic bone stabilization balloon, monitoring ring, and traction rod in an embodiment of the present invention; Figure 10 This is a schematic diagram of the cross-sectional structure of the photodynamic bone stabilization balloon in an embodiment of the present invention; Figure 11 This is a schematic diagram of the adapter structure in an embodiment of the present invention; Figure 12 This is a three-dimensional cross-sectional view of the catheter in an embodiment of the present invention; Figure 13 This is a schematic diagram of the cross-section of the catheter in an embodiment of the present invention; Figure 14 This is a schematic diagram of the optical fiber structure in an embodiment of the present invention; Figure 15 This is a schematic diagram of the optical fiber structure in an embodiment of the present invention.

[0029] Explanation of reference numerals in the attached figures: 1. Photodynamic bone stabilization balloon; 11. External balloon; 12. Internal balloon; 13. External infusion cavity; 14. Internal operating cavity; 111. Non-compliant balloon segment; 112. Compliant balloon segment; 113. Connecting groove; 114. Drug-releasing layer; 2. Catheter; 21. Injection channel; 22. Instrument channel; 23. Cooling channel; 3. Optical fiber; 31. Transparent sleeve; 32. Optical fiber; 33. Light-blocking plate; 311. Light-emitting part; 321. Light-emitting section; 322. Light-shielding section; 4. Adapter; 41. Vacuum port; 42. Liquid injection port; 43. Fiber optic port; 44. Coolant port; 411. Check valve; 422. Pressure gauge; 5. Monitoring ring; 6. Towing bar; 7. Medullary cavity; 71. Fracture fissure; 72. Area of ​​change in diameter. Detailed Implementation

[0030] 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. Based on the embodiments of the present invention, all other embodiments analyzed and obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] The purpose of this invention is to provide a photodynamic bone stabilization balloon and system to solve the problems existing in the prior art. The photodynamic bone stabilization balloon has a non-compliant balloon segment and a compliant balloon segment in the axial direction. The compliant balloon segment with limited deformability is used for the corresponding intramedullary fracture crack, while the compliant balloon segment with stronger deformability is used for adaptive expansion in the diameter change area of ​​the intramedullary cavity. This solves the contradiction between "excessive compliance leading to uncontrolled expansion and bone damage" and "insufficient compliance leading to poor fit and axial slippage".

[0032] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0033] Note: In this article, the front end is the end furthest from the practitioner, and the back end is the end closest to the practitioner.

[0034] Example 1 like Figures 1 to 15As shown, this embodiment provides a photodynamic bone stabilization balloon. The photodynamic bone stabilization balloon 1 includes an outer balloon 11 and an inner balloon 12. The outer balloon 11 encloses and is fixed to the inner balloon 12, and a fluid-filled external cavity 13 is formed between the outer balloon 11 and the inner balloon 12. The fluid-filled external cavity 13 is used to inject a photosensitive liquid containing an initiator to inflate the outer balloon 11. The inner balloon 12 has an operating cavity 14, which is used to connect an optical fiber 3. The optical fiber 3 transmits light energy to activate the initiator, thereby initiating a polymerization reaction of the photosensitive liquid. After polymerization, the photosensitive liquid solidifies, shaping the photodynamic bone stabilization balloon 1 and providing support and stability to the medullary cavity 7. After the photosensitive liquid has solidified, the optical fiber 3 needs to be withdrawn from the photodynamic bone stabilization balloon 1. The outer balloon 11 has a non-compliant balloon segment 111 and a compliant balloon segment 112 in the axial direction. The non-compliant balloon segment 111 has limited deformability and a maximum deformation range. Therefore, it is mainly used at fracture sites where the diameter of the medullary cavity 7 is not significantly different. At least one non-compliant balloon segment 111 is used at the corresponding fracture fissure 71 within the medullary cavity 7. Due to its limited deformability, it provides effective support while avoiding excessive expansion that could cause secondary damage to the fracture fissure 71. The compliant balloon segment 112 has strong deformability and can adapt to the shape of the medullary cavity 7. Therefore, it is mainly used within the medullary cavity 7 at non-fracture sites and in areas with varying diameters 72 to accommodate diverse bone cavity diameters. This provides sufficient anchoring force to the photodynamic bone stabilization balloon 1, preventing axial displacement.

[0035] In one embodiment of this example, the non-compliant balloon segment 111 is primarily made of thermoplastic polyurethane (TPU) or dense polyolefin copolymer (POC), possessing good compliance and flexibility. The balloon expands with pressure changes, better conforming to the irregular inner wall of the cavity. The compliant balloon segment 112 is primarily made of polyethylene terephthalate (PET), nylon, or semi-crystalline polymer (SCP).

[0036] In one embodiment of this invention, to further control the deformation capability of the non-compliant balloon segment 111, a fiber layer can be added within the balloon of the non-compliant balloon segment 111 to limit the device's expansion capability. The fiber layer may be, for example, PEEK fiber or a carbon fiber braided layer.

[0037] In one embodiment of this example, the non-compliant balloon segment 111 is located in the middle in the axial direction, and the compliant balloon segment 112 is located at both ends in the axial direction.

[0038] In one embodiment of this example, reference is made to Figure 2 and Figure 3 As shown, the external balloon 11 is a single balloon.

[0039] In one embodiment of this example, reference is made to Figure 5 and Figure 6 As shown, the external balloon 11 is a multi-sac, with the non-compliant balloon segment 111 located in the middle and the compliant balloon segments 112 located at both ends.

[0040] In one embodiment of this example, reference is made to Figure 8 As shown, the outer wall of the external balloon 11 has multiple circumferentially connected grooves 113. These grooves extend axially to the distal and proximal ends of the external balloon 11 to facilitate communication between the proximal and distal sides of the medullary cavity 7. This prevents the photodynamic bone stabilization balloon 1 from completely isolating the medullary cavity 7 from the proximal and distal sides, which would prevent the two sides from communicating and thus have adverse effects. Furthermore, the connected grooves 113 can accommodate bone marrow fragments and adipose tissue to prevent them from being squeezed into the venous system, thus avoiding problems such as venous thrombosis.

[0041] In one embodiment of this example, reference is made to Figure 10 As shown, the outer wall of the external balloon 11 is coated with a drug-release layer 114 for releasing functional agents. These functional agents include, for example, antibacterial agents and agents that promote bone healing. Agents that promote bone healing, for example, are bioactive substances selected from hydroxyapatite, β-tricalcium phosphate (β-TCP), and bone morphogenetic protein (BMP). Antibacterial agents, for example, are antibiotics to prevent infection.

[0042] In one embodiment of this invention, the operating cavity 4 can also be circulated with a cooling medium. The cooling medium is used for circulating cooling and to generate internal pressure on the photosensitive liquid within the injection cavity 13. Some of the photosensitive liquid releases heat during polymerization; excessive heat can easily cause tissue damage. Therefore, introducing a cooling medium can lower the temperature and prevent excessive heat. Simultaneously, it generates internal pressure on the photosensitive liquid within the injection cavity 13, preventing the inner balloon 12 from shrinking during injection or solidification of the photosensitive liquid. The cooling medium is typically a liquid.

[0043] Example 2 like Figures 1 to 15As shown, this embodiment provides a photodynamic bone stabilization system, including a photodynamic bone stabilization balloon 1, a catheter 2, an optical fiber 3, and a photosensitive liquid. The photodynamic bone stabilization balloon 1 is the same as that in Embodiment 1. The proximal end of the catheter 2 is detachably connected to the distal end of the photodynamic bone stabilization balloon 1 for delivery of the balloon. The catheter 2 has an injection channel 21 and an instrument channel 22. The injection channel 21 communicates with the injection outer cavity 13 of the photodynamic bone stabilization balloon 1 for injecting the photosensitive liquid. The instrument channel 22 communicates with the operating inner cavity 14 of the photodynamic bone stabilization balloon 1 for delivery of the optical fiber 3. The catheter 2 is rigid in the axial direction and flexible in the radial direction. The method of detaching and assembling the catheter 2 and the photodynamic bone stabilization balloon 1 is the current method of connecting a detachable balloon and catheter, which will not be described in detail here.

[0044] In one embodiment of this example, reference is made to Figure 1 and Figure 11 As shown, it also includes an adapter 4, which is connected to the proximal end of the catheter 2. The adapter 4 is equipped with a vacuum port 41, a liquid injection port 42, and an optical fiber port 43. The vacuum port 41 is connected to the liquid injection channel 21 and is used to evacuate the liquid injection cavity 13 to prevent air from remaining in the liquid injection cavity 13. The liquid injection port 42 is connected to the liquid injection channel 21 and is used to inject and withdraw the photosensitive liquid into the liquid injection cavity 13 to control the amount of photosensitive liquid injected, ensuring that the injection amount is within an appropriate range, avoiding insufficient injection for insufficient stabilization, or excessive injection leading to excessive expansion pressure and secondary damage to the fracture site. The optical fiber port 43 is connected to the instrument channel 22 and is used to deliver the optical fiber 3 into the operating cavity 14. After the optical fiber 3 is connected and the light source is turned on, the optical fiber 3 can transmit light energy to activate the initiator, thereby triggering the polymerization reaction of the photosensitive liquid to solidify, so that the photodynamic bone stabilization balloon 1 is shaped, achieving support and stabilization of the medullary cavity 7.

[0045] In one embodiment of this invention, the catheter 2 is further provided with a cooling channel 23, which is connected to the operating cavity 14 of the photodynamic bone stabilization balloon 1 for injecting a cooling medium. The adapter 4 is also provided with a coolant interface 44, which is connected to the cooling channel 23 for circulating and injecting a cooling medium into the operating cavity 14. The coolant interface 44, connected to the cooling channel 23, is used to circulate and inject a cooling medium into the operating cavity 14. During the photosensitive liquid polymerization reaction, heat is released. To avoid scalding the medullary cavity 7 or its internal bone marrow, timely cooling is necessary. Simultaneously, the cooling medium also provides some support, preventing the inner balloon 12 from shrinking during the injection of the photosensitive liquid into the outer cavity 13 of the outer balloon 11 and during solidification.

[0046] In one embodiment of this example, reference is made to Figure 11 As shown, the air extraction port 41 is equipped with a one-way valve 411 to prevent gas backflow during air extraction.

[0047] In one embodiment of this example, reference is made to Figure 11 As shown, the injection port 42 is equipped with a pressure gauge 422 to monitor the injection pressure in order to determine how much photosensitive monomer liquid to inject or how much to withdraw in order to maintain an appropriate injection volume.

[0048] In one embodiment of this example, reference is made to Figure 9 As shown, the system also includes a monitoring ring 5 and a traction rod 6. The monitoring ring 5 is fixed to the traction rod 6, which is rigid in the axial direction and flexible in the radial direction. The traction rod 6 can deliver the monitoring ring 5 into the operating cavity 14 through the fiber optic interface 43 and the instrument channel 22, and pull the monitoring ring 5 out of the operating cavity 14 when the photosensitive liquid polymerization reaction is complete. The outer wall of the monitoring ring 5 is used to fit against the inner wall of the operating cavity 14, and a pressure sensor is provided on the outer wall of the monitoring ring 5. The pressure sensor can monitor the internal compression pressure of the inner balloon 12, that is, the injection pressure of the injection cavity 13 of the outer balloon 11, and thus, together with the injection pressure monitored by the pressure gauge 422, determine the amount of photosensitive liquid injected. After the photosensitive liquid solidifies, the monitoring ring 5 needs to be pulled out of the photodynamic bone stabilization balloon 1 by the traction rod 6 to prevent electronic devices (such as pressure sensors and temperature sensors) from remaining in the medullary cavity 7 and avoid problems.

[0049] In one embodiment of this example, a temperature sensor is also provided on the outer wall of the monitoring ring 5. The temperature sensing device is used to monitor the temperature of the cooling medium and determine the amount and rate of cooling medium injection. Typically, the thermal damage threshold of bone tissue is about 47°C. Therefore, it is necessary to strictly control the temperature of the outer balloon 11 and the bone interface to not exceed this thermal damage threshold in order to avoid thermal necrosis of the surrounding bone tissue.

[0050] In one embodiment of this invention, a developing material or a developing agent is added to the monitoring ring 5 to cooperate with the developing equipment in locating the photodynamic bone stabilization balloon 1. The developing material or developing agent is selected from one or more of barium sulfate, zirconium oxide, tungsten powder, tantalum powder, etc., to enhance the visibility of X-ray imaging.

[0051] In one embodiment of this example, reference is made to Figure 15As shown, the optical fiber 3 includes a transparent sleeve 31 and multiple optical fibers 32, which are fixed inside the transparent sleeve 31. Each optical fiber 32 is divided into a light-emitting segment 321 and a light-blocking segment 322 in the axial direction, with the light-emitting segment 321 located at the far end of the optical fiber 32. The light-emitting segments 321 of the multiple optical fibers 32 are staggered from far to near in the axial direction to form several independently emitting light-emitting sections 311 in the axial direction of the transparent sleeve 31. Each optical fiber 32 is independently connected to the lighting control panel. Light is supplied to the corresponding optical fiber 32 only when the light-emitting section 311 of the transparent sleeve 31 needs to emit light. For example, if the light-emitting section 311 at the far end of the transparent sleeve 31 needs to emit light, only the optical fiber 32 with the farthest light-emitting segment 321 is activated, while the other optical fibers 32 remain closed. Preferably, the curing can proceed gradually from the fracture crack 71 towards both ends. This has the advantage of optimizing the distribution of shrinkage stress during the curing process and reducing the debonding of the polymer interface with the bone wall.

[0052] In one embodiment of this example, reference is made to Figure 15 As shown, the light-emitting parts 311 of the transparent sleeve 31 are separated by a light-blocking plate 33 to prevent multiple light-guiding fibers 32 from crossing each other in the axial direction, so that the light from the light-emitting parts 311 propagates only in the radial direction as much as possible. In this way, depending on the needs, the corresponding light-emitting part 311 is activated to determine which part of the photodynamic bone stabilizing balloon 1 should solidify first, and the corresponding part should solidify later.

[0053] In one embodiment of this example, the photosensitive liquid contains at least one multifunctional methacrylate monomer.

[0054] In one embodiment of this example, the multifunctional methacrylate monomer is any one or a combination of urethane dimethacrylate (UDMA), triethylene glycol dimethacrylate (TEGDMA), and bisphenol A dimethacrylate (Bis-GMA).

[0055] In one embodiment of this example, an initiator such as CQ (camphorquinone) is used in a two-component system with a DMAEMA-type amine promoter.

[0056] Instructions for use of photodynamic bone stabilization system: Step 1: Adjust the patient's position according to the required surgical exposure range, make a soft tissue incision, and establish a bone inlet on the bone to enter the medullary cavity 7. Remove the medullary cavity 7 from the fracture surface through the bone inlet to provide a channel for the photodynamic bone stabilization balloon 1. Measure the diameter of the bone inlet and select the required catheter 2 size (length and diameter). Step 2: Insert the guide wire, insert the dilator and sheath into the medullary canal 7 through the bone inlet, remove the guide wire and dilator, and leave the sheath covering the fracture surface. Step 3: Prepare the photodynamic bone stabilization balloon 1 for implantation. Connect the air extraction port 41 to the air extraction syringe, open the valve of the air extraction port 41, and operate the air extraction syringe to expel all the air in the injection cavity 13. When the protective tube covers the photodynamic bone stabilization balloon 1, connect the injection port 42 to the syringe filled with photosensitizing liquid to pre-fill the photodynamic bone stabilization balloon 1 with liquid and expel the air bubbles in the injection cavity 13. Then close the valve of the air extraction port 41. Step 4: Remove the pre-filled photodynamic bone stabilization balloon 1 from the protective tube, insert the distal end of the photodynamic bone stabilization balloon 1 into the sheath tube that has been placed in the medullary cavity 7, and confirm by fluoroscopic examination that the photodynamic bone stabilization balloon 1 is completely inserted into the sheath tube, and ensure that the non-compliant balloon segment 111 is in the correct position at the fracture site (fracture fissure 71). Step 5: Remove the sheath from the medullary cavity 7 while keeping the photodynamic bone stabilization balloon 1 in place; Use a syringe filled with photosensitive fluid to completely inject into the external cavity 13 of the photodynamic bone stabilization balloon 1; Confirm the fracture alignment by fluoroscopic examination; If adjustment is needed, some photosensitive fluid can be withdrawn through the injection port 42 to release the balloon pressure, and then the photodynamic bone stabilization balloon 1 can be carefully repositioned and / or the fracture reduced. Step Six: Transfer the fiber optic hub from the sterile area to the circulating nurse and insert it into the nasal cone of the photodynamic control console; once the photodynamic bone stabilization balloon 1 is inflated and the fracture alignment is confirmed, activate the LED photodynamic control console by pressing the "Activate" button on the LCD screen to begin phototherapy irradiation to promote monomer solidification; during the solidification process, coolant is circulated into the operating cavity 14 of the photodynamic bone stabilization balloon 1 through the coolant interface 44; after the photodynamic circulation is completed, remove the fiber optic cable 3 from the fiber optic interface 43 and stop the injection of coolant; Step 7: Use instruments to separate catheter 2 from the solidified photodynamic bone stabilization balloon 1; perform wound closure and fixation as needed; remove the fiber optic hub from the nasal cone of the lighting control console; and turn off the power to the lighting control console.

[0057] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A photodynamic bone stabilization balloon, characterized in that, The device includes an outer balloon (11) and an inner balloon (12); the outer balloon (11) is wrapped around and fixed outside the inner balloon (12), and an external infusion cavity (13) is formed between the outer balloon (11) and the inner balloon (12); the external infusion cavity (13) is used to inject a photosensitive liquid containing an initiator to expand the outer balloon (11); the inner balloon (12) has an operating cavity (14), which is used to transmit light energy to activate the initiator to initiate a polymerization reaction of the photosensitive liquid; the outer balloon (11) has a non-compliant balloon segment (111) and a compliant balloon segment (112) in the axial direction, at least one of the non-compliant balloon segments (111) is used to correspond to the fracture crack (71) in the medullary cavity (7), and the compliant balloon segment (112) is used to correspond to the diameter change region (72) in the medullary cavity (7).

2. The photodynamic bone stabilizing balloon according to claim 1, characterized in that, The non-compliant balloon segment (111) is located in the middle in the axial direction, and the compliant balloon segment (112) is located at both ends in the axial direction.

3. The photodynamic bone stabilizing balloon (1) according to claim 1 or 2, characterized in that, The external balloon (11) is a single balloon.

4. The photodynamic bone stabilizing balloon according to claim 1 or 2, characterized in that, The external balloon (11) is a multi-sac, with the sac in the middle being a non-compliant balloon segment (111) and the sacs at both ends being compliant balloon segments (112).

5. The photodynamic bone stabilizing balloon according to claim 1, characterized in that, The outer wall of the external balloon (11) is provided with a plurality of connecting grooves (113) along the circumferential direction. The connecting grooves (113) extend axially to the distal and proximal ends of the external balloon (11) to connect the bone marrow on the proximal and distal sides of the medullary cavity (7).

6. The photodynamic bone stabilizing balloon according to claim 1, characterized in that, The outer wall of the outer balloon (11) is coated with a drug-release layer (114) for releasing functional drugs.

7. The photodynamic bone stabilizing balloon according to claim 1, characterized in that, The operating cavity (14) can also be circulated with a cooling medium, which is used for circulating cooling and generating internal pressure on the photosensitive liquid in the injection cavity (13).

8. A photodynamic bone stabilization system, characterized in that, The device includes a catheter (2), an optical fiber (3), a photosensitive liquid, and a photodynamic bone stabilization balloon (1) as described in any one of claims 1-7; the proximal end of the catheter (2) is detachably connected to the distal end of the photodynamic bone stabilization balloon (1) to deliver the photodynamic bone stabilization balloon (1); the catheter (2) is provided with an injection channel (21) and an instrument channel (22); the injection channel (21) is connected to the injection outer cavity (13) of the photodynamic bone stabilization balloon (1) for injecting the photosensitive liquid; the instrument channel (22) is connected to the operating inner cavity (14) of the photodynamic bone stabilization balloon (1) for delivering the optical fiber (3).

9. The photodynamic bone stabilization system according to claim 8, characterized in that, It also includes an adapter (4), which is connected to the proximal end of the catheter (2). The adapter (4) is provided with a vacuum port (41), a liquid injection port (42), and an optical fiber port (43). The vacuum port (41) is connected to the liquid injection channel (21) and is used to evacuate the liquid injection outer cavity (13). The liquid injection port (42) is connected to the liquid injection channel (21) and is used to inject and withdraw the photosensitive liquid into the liquid injection outer cavity (13). The optical fiber port (43) is connected to the instrument channel (22) and is used to deliver the optical fiber (3) to the operating inner cavity (14).

10. The photodynamic bone stabilization system according to claim 9, characterized in that, The air extraction port (41) is equipped with a one-way valve (411) to prevent gas backflow.

11. The photodynamic bone stabilization system according to claim 9, characterized in that, The catheter (2) is also provided with a cooling channel (23), which is connected to the operating cavity (14) of the photodynamic bone stabilization balloon (1) for injecting cooling medium; the adapter (4) is also provided with a coolant interface (44), which is connected to the cooling channel (23) for circulating and injecting cooling medium into the operating cavity (14).

12. The photodynamic bone stabilization system according to any one of claims 9-11, characterized in that, The injection port (42) is equipped with a pressure gauge (422) for monitoring the injection pressure.

13. The photodynamic bone stabilization system according to claim 12, characterized in that, It also includes a monitoring ring (5) and a traction rod (6). The monitoring ring (5) is fixed on the traction rod (6). The traction rod (6) is rigid in the axial direction and flexible in the radial direction. The traction rod (6) can deliver the monitoring ring (5) into the operating cavity (14) through the optical fiber interface (43) and the instrument channel (22), and pull the monitoring ring (5) out of the operating cavity (14) when the photosensitive liquid polymerization reaction is completed. The outer wall of the monitoring ring (5) is used to fit against the inner wall of the operating cavity (14). A pressure sensor is provided on the outer wall of the monitoring ring (5).

14. The photodynamic bone stabilization system according to claim 12, characterized in that, A temperature sensor is also provided on the outer wall of the monitoring ring (5).

15. The photodynamic bone stabilization system according to claim 13, characterized in that, The monitoring ring (5) contains a developing material or the photosensitive liquid contains a developing agent, in order to cooperate with the developing equipment to locate the position of the photodynamic bone stabilization balloon (1).

16. The photodynamic bone stabilization system according to claim 8, characterized in that, The optical fiber (3) includes a transparent sleeve (31) and multiple optical fibers (32), which are arranged inside the transparent sleeve (31). Each optical fiber (32) is divided into a light-emitting segment (321) and a light-shielding segment (322) in the axial direction. The light-emitting segment (321) is located at the far end of the optical fiber (32). The light-emitting segments (321) of the multiple optical fibers (32) are arranged in a staggered manner from far to near in the axial direction to form several independently light-emitting parts (311) in the axial direction of the transparent sleeve (31). Each optical fiber (32) is independently connected to the lighting control console.

17. The photodynamic bone stabilization system according to claim 16, characterized in that, The light-emitting parts (311) of the transparent sleeve (31) are separated by a light-blocking plate (33) to prevent the multiple light guide fibers (32) from crossing each other in the axial direction.

18. The photodynamic bone stabilization system according to claim 8, characterized in that, The photosensitive liquid contains at least one multifunctional methacrylate monomer.

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