Pulmonary artery balloon blocking hemostasis device for lung cancer surgery

Abstract

The invention relates to a pulmonary artery balloon blocking hemostasis device for lung cancer surgery. The pulmonary artery balloon blocking hemostasis device comprises a puncture assembly and a balloon catheter assembly. The puncture assembly comprises a puncture needle core and a puncture sheath tube; a limiter is sleeved on the puncture sheath tube, sheath tube scales are arranged on a tube body, and the depth of the puncture sheath tube inserted into a pulmonary artery blood vessel is determined by adjusting the position of the limiter on the sheath tube scales; the puncture needle core penetrates into the puncture sheath tube, and the head end extends out of the puncture sheath tube for implementing puncture operation; the balloon catheter assembly comprises a balloon catheter and a balloon connected to the outer portion of the balloon catheter in a sleeving mode. The balloon catheter can stretch into the puncture sheath tube and enables the balloon to stretch out of the puncture sheath tube. The near end of the balloon catheter is externally connected with a medical tee joint or directly externally connected with an injector; a puncturable silica gel membrane is arranged at the near end of the puncture sheath tube and used for preventing blood from flowing back when the puncture needle core and the balloon catheter retreat.

Description

A pulmonary artery balloon occlusion hemostasis device for lung cancer surgery Technical Field

[0001] This invention relates to a pulmonary artery balloon occlusion hemostasis device for lung cancer surgery. It is used to perform emergency occlusion of the upstream pulmonary artery in case of accidental pulmonary artery rupture and bleeding during the separation of lung lobes or lung segments to remove tumors, so as to achieve hemostasis and controllable surgical operation. It belongs to the field of medical device technology. Background Technology

[0002] Thoracic lobectomy and segmentectomy are core surgical procedures for lung cancer. With the development of minimally invasive thoracic surgery techniques, thoracoscopic and robot-assisted lung resection has gradually become the mainstream, which places higher demands on surgical precision and intraoperative safety control.

[0003] During tumor and lung tissue dissection, the management of the pulmonary artery system remains a critical aspect and a major source of risk. The pulmonary artery and its branches have thin, fragile walls and are often surrounded by inflammatory adhesions or enlarged lymph nodes, making them highly susceptible to accidental tearing or injury during instrumental separation, traction, or manipulation with energy devices (such as ultrasonic scalpels and electrocoagulation hooks). A ruptured pulmonary artery can lead to instantaneous and massive hemorrhage, rapidly flooding the surgical field with blood, causing not only contamination but also forcing the surgery into an emergency rescue situation.

[0004] Currently, the management of intraoperative iatrogenic pulmonary hemorrhage relies heavily on the surgeon's personal experience and emergency response. Routine measures include using vascular clamps to clamp the rupture, manual compression to stop the bleeding, or attempting suture repair within the pool of blood. However, due to the limited operating space within the thoracic cavity and the difficulty in locating the bleeding point, these methods often suffer from poor visibility and reduced precision, potentially leading to secondary injury or hemostasis failure. This can result in serious complications such as hemorrhagic shock and air embolism, directly endangering the patient's life.

[0005] Existing vascular control technologies, such as aortic balloon occlusion, are primarily used for trauma resuscitation or major vascular surgery. Their instrument specifications and operational concepts are not suitable for the delicate pulmonary artery branch anatomy in lung surgery. Currently, in the field of lung cancer surgery, there is a lack of an active pulmonary artery blood flow control device that can be rapidly established and readily available in the event of iatrogenic bleeding. This lack of such a device makes it difficult for surgical teams to quickly and effectively stop bleeding, leaving them in a passive and panicked state, and potentially endangering the patient's life.

[0006] Therefore, there is an urgent need in clinical practice for a rapid hemostatic device specifically designed for lung cancer surgery. This device aims to rapidly establish a controllable temporary occlusion channel within the target pulmonary artery through minimally invasive techniques, thereby transforming uncontrollable bleeding into a manageable emergency measure. This not only greatly improves the safety of the surgery and creates favorable conditions for the surgeon to manage the blood vessels with ease, but also aligns with the modern thoracic surgery trend towards precision, controllability, and minimal damage. Summary of the Invention

[0007] The present invention aims to provide a pulmonary artery balloon occlusion hemostasis device for lung cancer surgery, which aims to solve the technical problems of high risk of massive bleeding and difficulty in emergency hemostasis caused by accidental pulmonary artery injury in existing lung cancer surgery, and to provide a device that can quickly establish hemostasis in emergency bleeding and achieve active and controllable hemostasis.

[0008] The present invention adopts the following technical solution:

[0009] A pulmonary artery balloon occlusion hemostasis device for lung cancer surgery includes a puncture assembly and a balloon catheter assembly. The puncture assembly includes a puncture needle core 1 and a puncture sheath 2. A limiter 203 is fitted onto the puncture sheath 2, and the sheath body has a sheath scale 202. The depth of insertion of the puncture sheath 2 into the pulmonary artery is determined by adjusting the position of the limiter 203 on the sheath scale 202. The puncture needle core 1 is inserted into the puncture sheath 2, with its tip extending out of the puncture sheath 2 for puncture operation. The balloon catheter assembly includes a balloon catheter 302 and a balloon 301 fitted onto it. The balloon catheter 302 can extend into the puncture sheath 2 and allow the balloon 301 to extend out of the puncture sheath 2. The proximal end of the balloon catheter 302 is connected to a medical three-way stopcock or directly to a syringe (as shown in Figure 8). A puncturable silicone membrane 205 is provided at the proximal end of the puncture sheath 2 to prevent blood backflow when the puncture needle core 1 and balloon catheter 302 are withdrawn.

[0010] It should be noted that the shape of the medical three-way valve is existing technology in this field. In Figure 6, a medical three-way valve 201 for connecting an external syringe is also connected to the side wall of the connector 204 at the proximal end of the puncture sheath 2. Its function is unrelated to the purpose of this invention. It is for use when it is necessary to inject medication directly into the blood vessel using the puncture sheath. It is a backup function and is unrelated to the core function described in this embodiment.

[0011] Preferably, the puncture needle core 1 is made of medical stainless steel. The puncture needle core 1 has two specifications. One is suitable for thoracoscopic surgery, with a length of 350mm-450mm, which makes it convenient for the surgeon to perform pulmonary artery puncture at the puncture site. The other is suitable for open surgery, with a length of 120mm, which makes it convenient for the surgeon to directly touch the pulmonary artery by hand to perform puncture.

[0012] Preferably, the tip of the puncture sheath 2 is a blunt-tipped structure made of soft polymer. Its function is that when the puncture needle core 1 is pulled out, the tip of the puncture sheath 2 left in the blood vessel can minimize the stimulation and damage to the vascular endothelium and reduce the risk of thrombosis.

[0013] Preferably, the sheath scale 202 is a precision depth scale line in millimeters, which, in conjunction with the limiter 203, provides the operator with intuitive feedback on the puncture depth.

[0014] Preferably, the limiter 203 is a mechanical buckle or knob mechanism that can slide and lock onto the sheath tube.

[0015] Preferably, the puncturable silicone membrane 205 is located at the end of the cannula and adopts a puncturable silicone membrane type one-way valve that tightens after needle removal. Its function is to prevent blood backflow and maintain the cleanliness of the surgical field when inserting or withdrawing the balloon catheter, while ensuring that gas does not leak through the cannula.

[0016] Preferably, the balloon catheter 302 is a flexible multilayer composite tube, which is composed of a polymer material embedded with a metal braided mesh; the balloon 301 is made of highly compliant medical-grade transparent silicone or polyurethane, and its rated blocking diameter ranges from 3 mm to 30 mm.

[0017] Furthermore, the balloon catheter 302 has a liquid inlet located at the tail end of the balloon catheter 302, and is equipped with a self-sealing valve that can be quickly connected to a standard syringe Luer connector or a medical tee.

[0018] Furthermore, the balloon catheter 302 controls the inflation and deflation of the balloon 301 by injecting a predetermined volume of methylene blue solution; a label may be provided next to the inlet port to indicate the rated volume and maximum recommended pressure of the balloon 301.

[0019] The beneficial effects of this invention are as follows:

[0020] 1) Rapid hemostasis, turning passive into active: This device reshapes the prevention and control strategy for intraoperative pulmonary hemorrhage, pioneering two tiered application paradigms and promoting the upgrading of surgical safety modes:

[0021] Proactive prophylaxis (for high-risk, complex cases): For cases where preoperative assessment indicates tight adhesion between the pulmonary artery and tumor or lymph nodes, with an extremely high risk of separation and rupture (such as after neoadjuvant therapy or locally advanced lung cancer), this device can be used as a standard prophylactic configuration before surgery. Its significance lies in transforming a potentially catastrophic hemorrhage into a controllable and predictable planned event. In the event of intraoperative vascular rupture, balloon occlusion can be initiated within seconds, creating a bloodless field for efficient suturing and repair, turning crisis rescue into planned control.

[0022] Emergency safety precautions (for routine or unexpected bleeding cases): This can be used as a backup measure in routine surgeries or cases with low preoperative risk assessments. In the event of unexpected pulmonary hemorrhage during surgery, after initial gauze pad compression, this device can be rapidly inserted to achieve definitive blood flow occlusion. This avoids secondary damage caused by blindly clamping and suturing in a pool of blood, buying the team valuable decision-making and operational time, and significantly improving hemostasis success rates and surgical safety in emergency situations.

[0023] 2) Controllable operation and high safety: The depth scale and adjustable limiter on the puncture sheath effectively prevent excessive puncture and improve the safety of operation.

[0024] 3) Repeatable testing: After the main surgical steps are completed, the balloon can be deflated to observe whether there is bleeding at the lung tissue stump that was originally planned to be removed. If there is bleeding, the balloon can be re-inflated to stop the bleeding. Supplemental hemostasis can be performed in the absence of blood, thus ensuring the quality of the surgery.

[0025] 4) Minimally invasive and protective: Puncture and catheter placement causes minimal trauma, and the impact on blood vessels and surrounding tissues is far less than the damage caused by blind clamping in an emergency.

[0026] 5) Improve surgical smoothness: It fundamentally relieves the surgeon of the psychological burden of sudden massive bleeding, allowing the surgeon to focus more on fine dissection and precise resection, which may shorten the overall operation time.

[0027] 6) The ultimate value of this invention lies in significantly expanding the surgical indications and safety boundaries of lung cancer surgery, especially for complex cases that were previously considered "surgical no-go zones" or minimally invasive no-go zones:

[0028] Faced with "door nail-like" infiltrative lesions: When metastatic lymph nodes are severely fused with the pulmonary artery wall and cannot be separated, traditional methods often force conversion to open thoracotomy or abandonment of radical treatment. After endovascular blood flow is blocked using this device, the surgeon can calmly perform "precise cutting" within the vascular sheath or resection and reconstruction of the affected vascular segment in a bloodless state, ensuring complete tumor resection while preserving healthy tissue to the maximum extent, thus achieving a balance between radical treatment and safety;

[0029] Promoting the standardization of surgery after neoadjuvant therapy: These patients have severe perivascular fibrosis, making dissection exceptionally difficult, and are a high-risk group for pulmonary artery injury. This device provides a reliable safety guarantee, enabling surgeons to more aggressively perform complex surgeries, thereby allowing more patients with locally advanced lung cancer to benefit from comprehensive treatment.

[0030] In summary, this invention provides a specific hemostatic tool for use in lobectomy and segmentectomy, transforming the "uncontrollable disaster" of massive pulmonary hemorrhage into a "preventable and controllable technical aspect." This greatly enhances surgeons' confidence and ability to tackle complex surgeries and has significant clinical and socioeconomic value for improving the overall diagnosis and treatment of lung cancer. Attached Figure Description

[0031] Figure 1 is a front view of a puncture sheath according to an embodiment of the present invention.

[0032] Figure 2 is a three-dimensional schematic diagram of a puncture sheath in one embodiment of the present invention.

[0033] Figure 3 is a cross-sectional view of AA in Figure 2.

[0034] Figure 4 is a schematic diagram of the puncture needle core in one embodiment of the present invention.

[0035] Figure 5 is a schematic diagram of the combination of the puncture needle core and the puncture sheath in one embodiment of the present invention.

[0036] Figure 6 is a perspective view of the combination of the puncture needle core and the puncture sheath in one embodiment of the present invention.

[0037] Figure 7 is a rendering schematic diagram of the combination of the puncture needle core and the puncture sheath in one embodiment of the present invention.

[0038] Figure 8 is a schematic diagram of the external shape of a balloon catheter assembly according to an embodiment of the present invention.

[0039] Figure 9 is a detailed view of a balloon catheter assembly according to an embodiment of the present invention.

[0040] Figure 10 is a schematic diagram of the puncture needle core being inserted into the pulmonary artery. At this point, the balloon catheter has not yet entered.

[0041] Figure 11 is a schematic diagram of pulmonary artery blood flow being blocked after balloon inflation.

[0042] In the picture:

[0043] 1. Puncture needle stylet, 2. Puncture sheath, 3. Balloon catheter assembly,

[0044] 101. The tip of the puncture needle;

[0045] 201. Medical tee, 202. Sheath graduations, 203. Limiter, 204. Connector, 205. Punctureable silicone membrane;

[0046] 301. Balloon, 302. Balloon catheter. Detailed Implementation

[0047] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0048] The terms “proximal,” “distal,” and “head” used in this article are based on the relative orientation and position of the various parts and components of a medical device. Although not restrictive, “proximal” usually refers to the end of the medical device that is closer to the surgeon during normal use, while “distal” and “head” usually refer to the end of the medical device that is farther away from the surgeon.

[0049] Referring to Figures 1-10, a pulmonary artery balloon occlusion hemostasis device for lung cancer surgery includes:

[0050] The puncture assembly, used to achieve minimally invasive puncture of blood vessels and establish instrument access, specifically includes:

[0051] The puncture needle core 1 is made of high-strength medical-grade stainless steel, with a beveled, acute-angled tip to ensure precise and low-resistance penetration of the pulmonary artery wall. This puncture needle core 1 comes in two sizes. The first type is suitable for thoracoscopic surgery, with a length close to that of the grasping forceps currently used in thoracoscopic surgery (approximately 350mm-450mm), facilitating pulmonary artery puncture at the puncture site. The second type is suitable for open surgery, with a length slightly longer than existing superficial artery puncture devices, approximately 120mm, allowing the surgeon to directly palpate the pulmonary artery for puncture. The schematic diagrams in this application (Figures 1 and 5) illustrate the second type of length.

[0052] Puncture sheath 2: Fitted around the puncture needle core 1, together with the puncture needle core 1, forming the puncture assembly. The tip of the puncture sheath is made of a soft polymer (such as polyurethane) with a blunt tip design. The purpose of this design is to minimize irritation and damage to the vascular endothelium when the needle core is removed, thereby reducing the risk of thrombosis.

[0053] The outer wall of the puncture sheath 2 is marked with precise depth graduations in millimeters (one graduation per 1 mm), providing the operator with intuitive feedback on the puncture depth.

[0054] Depth-limiting stopper 203: This is a sliding and locking mechanical latch or knob mechanism that attaches to the cannula. The operator can pre-set the maximum puncture depth based on preoperative imaging measurements or intraoperative visual assessment. When the stopper 203 contacts the skin or outer wall of the blood vessel, it prevents the cannula from penetrating further, effectively preventing excessive puncture and damage to the posterior wall of the blood vessel or posterior tissues, greatly improving the safety of the procedure.

[0055] Hemostasis device: Located near the proximal end of the puncture sheath 2, it uses a puncturable silicone membrane 205 as a plate-type one-way valve, which tightens after needle removal, as shown in Figure 6. Its function is to prevent blood backflow and maintain the cleanliness of the surgical field when inserting or withdrawing the puncture needle core 1 and balloon catheter 3, while ensuring that gas does not leak through the cannula.

[0056] Figure 5 is a schematic diagram of the combination of puncture needle and sheath. It should be noted that the tip of the puncture needle core 1 can be bluntly inserted into the sheath and then pushed out after reaching the puncture position to avoid damage along the way.

[0057] Figure 8 shows balloon catheter assembly 3. This balloon catheter assembly 3 is the core component for performing blood flow occlusion.

[0058] Balloon catheter 302: This is a long-diameter, flexible, multi-layered composite tube made of a polymer material (such as Pebax) with an embedded metal braided mesh. This structure ensures both torque transmission and resistance to collapse during catheter advancement within the blood vessel, while also providing sufficient flexibility to conform to the vessel's orientation.

[0059] Balloon 301: Located at the distal end of the catheter, it is connected to the inlet hole on the side wall of the catheter.

[0060] Materials and Design: Made of highly compliant medical-grade transparent silicone or polyurethane. Its rated blocking diameter ranges from 3mm to 30mm, a size range based on anatomical statistics of pulmonary artery branches in the Chinese population, designed to cover the vast majority of target vessels from the subsegmental level (~3mm) to the lobar level (~10mm).

[0061] Shape: When inflated at rated pressure, balloon 301 takes the shape of a spindle or a low-profile cylinder. This shape maximizes the contact area with the vessel wall while applying uniform radial pressure to the vascular intima, thereby achieving reliable blood flow occlusion and minimizing the risk of pinpoint lacerations to the vascular endothelium.

[0062] The inlet port is located proximal to the balloon catheter 302, connecting to the distal balloon 301 via the catheter sidewall. It features a self-sealing valve for quick connection to a medical three-way stopcock or a standard syringe Luer connector. Balloon inflation and deflation are controlled by injecting a predetermined volume of methylene blue solution. A label next to the port indicates the balloon's rated volume and maximum recommended pressure. Injecting methylene blue solution allows real-time visualization of the balloon's position within the blood vessel for accurate positioning.

[0063] Key points of the operation process:

[0064] S1. Exposure and preparation: Fully detach and expose the target pulmonary artery segment, and pre-position hemostasis at the pre-puncture point using a purse-string suture.

[0065] S2. Direct puncture: The cannula (i.e., the puncture needle and sheath are integrated) is directly inserted into the blood vessel. After bleeding is observed, the puncture needle is fixed, the sheath is pushed into the blood vessel lumen, and then the puncture needle is removed.

[0066] S3. Balloon insertion: Quickly insert the balloon catheter through the sheath to the proximal end of the bleeding point, inject normal saline to inflate the balloon, block blood flow, and achieve hemostasis.

[0067] S4. Fixation and Maintenance: Secure the sheath and catheter to prevent them from dislodging.

[0068] Note: Unlike percutaneous puncture, the core risk of open direct puncture is not "accidental puncture," but rather "bleeding" and "tearing." Therefore, the procedure revolves around "how to reliably close the puncture site." Due to high pulmonary artery pressure, even a small puncture site can easily lead to uncontrollable spurting bleeding or the formation of a pseudoaneurysm after sheath removal. Therefore, a purse-string suture must be made around the puncture site with non-absorbable sutures before puncture. After sheath removal, the purse-string suture is immediately tightened to close the puncture site. Sometimes, even a double purse-string suture is necessary to ensure safety.

[0069] To better understand the embodiments of the present invention, the following explanation, based on the principles of the present invention, explains why the present invention should be implemented.

[0070] In lung cancer surgery, intraoperative pulmonary artery rupture leading to massive hemorrhage is the most dangerous complication, characterized by rapid onset and high mortality, representing a critical bottleneck limiting surgical safety. Traditional pulmonary artery occlusion relies on extracorporeal physical compression, which has the following inherent drawbacks:

[0071] Firstly, the operation has a large blind spot, especially for the right pulmonary artery trunk with complex anatomy and "door nail-like" lesions where tumors or metastatic lymph nodes tightly infiltrate the vessel wall, making vessel dissection difficult and time-consuming.

[0072] Secondly, the location is unclear and the anatomical layers are not well understood; forced separation can easily cause secondary injuries.

[0073] Third, incomplete occlusion carries a high risk, especially under minimally invasive thoracoscopic views, where completely reliable extracavitary compression is difficult to achieve. Therefore, developing a dedicated active, precise, and safe control tool for the pulmonary artery is of significant clinical importance.

[0074] The core innovation of this invention lies in combining the optical properties of venous blood with endovascular interventional techniques to achieve visualized and precise endovascular occlusion, thereby fundamentally avoiding the inherent risks of extravascular procedures. Its design is primarily based on the following three core principles:

[0075] I. The principle of mechanical blockade in hemodynamics

[0076] Based on Pascal's hydrostatic principle, this device achieves rapid hemostasis by injecting a balloon filled with fluid into a blood vessel, causing it to expand radially within the closed vascular space. The balloon forms a tight circumferential fit with the vascular intima, applying uniform radial pressure to the vessel wall. This pressure exceeds the local arterial pressure, thus physically blocking blood flow and achieving immediate hemodynamic isolation. This is the physical basis for the device's ability to achieve rapid hemostasis.

[0077] II. Principles of Precise Channel Establishment in Vascular Intervention

[0078] Drawing upon and optimizing the Seldinger vascular puncture technique, key improvements were made to address the unique challenges posed by the thin and vulnerable pulmonary artery walls and the limited intrathoracic operating space:

[0079] Puncture safety design: It adopts a "sharp core and blunt sheath" combination structure. The high-strength sharp needle core ensures accurate and minimally invasive penetration of the tough arterial wall, while the indwelling soft blunt-tipped cannula minimizes the risk of continuous stimulation and damage to the vascular intima, effectively preventing puncture site-related complications (such as dissection and thrombosis).

[0080] Depth controllability design: The puncture sheath is equipped with precise graduations and a sliding, locking depth limiter, forming a visual depth control system. Based on precise considerations of the pulmonary artery wall thickness and the anatomical space within the thoracic cavity, strict mechanical limiting fundamentally prevents posterior wall penetration or contralateral damage caused by excessively deep puncture, minimizing operational risks.

[0081] III. Morphological Adaptation Principles Based on Target Vascular Anatomy

[0082] The effectiveness of the device ultimately depends on the morphological match between the balloon and the target blood vessel:

[0083] Size fit: The rated occlusion diameter range of the balloon (3mm to 30mm) is strictly set according to the anatomical data of the pulmonary lobe and segmental arteries in the Chinese population to ensure effective coverage of most target vessels from the subsegmental level to the pulmonary lobe level, and avoid occlusion failure or over-expansion damage due to size mismatch.

[0084] Morphological optimization: The balloon adopts a spindle-shaped or low-profile cylindrical shape to provide the maximum effective contact area under a given filling pressure. This ensures reliable occlusion and significantly reduces point pressure on the vascular endothelium by uniformly distributing the contact pressure. It effectively blocks blood flow while maximizing the protection of vascular integrity, which is in line with the surgical concept of "damage control".

[0085] IV. Visualization (non-percutaneous entry) and precise positioning principle

[0086] This invention is performed under visualization during surgery. Percutaneous balloon hemostasis is an external remote emergency technique used in interventional radiology, and all designs revolve around external blind puncture, precise vascular location, and avoiding accidental puncture. In contrast, this solution is a dedicated safety technique for intraoperative direct visualization in thoracic surgery. All designs are based on the characteristics of thin and vulnerable pulmonary artery walls, limited thoracic operating space, and easy bleeding after puncture. It is a systematic and specialized innovation for lobectomy and segmentectomy of lung cancer.

[0087] Based on the physiological characteristics of low oxygen saturation in the pulmonary artery and the translucency of the arterial wall, methylene blue staining is added to the balloon filling fluid. This staining agent has high biocompatibility and is widely used in clinical marking. By creating a distinct color difference, it enables real-time visual monitoring of the balloon's position within the blood vessel lumen during surgery, and precise millimeter-level localization of the occlusion location. This fundamental innovation elevates pulmonary artery occlusion from experience-based blind operation to visualized precision control, laying a technological foundation for safe control.

[0088] In summary, this invention, based on clinical pain points, precise intervention, and the anatomical characteristics of human pulmonary vessels, represents a systematic and targeted innovation in concepts and technological improvements. Its core value lies in fundamentally avoiding the inherent risks of extravascular manipulation by directly targeting the pulmonary artery via intravascular access. This achieves targeted control of the area with the highest bleeding risk, providing lung cancer surgery with a previously lacking proactive safety control tool specifically for the pulmonary artery, completely changing the passive situation in dealing with intraoperative pulmonary artery bleeding.

[0089] A specific example:

[0090] Step 1: Preoperative preparation and device confirmation:

[0091] Based on the target pulmonary artery diameter measured by preoperative CT angiography (e.g., 7 mm), select the corresponding balloon occlusion device from the product kit (balloon rated occlusion diameter is 5 mm).

[0092] Check the integrity of the product packaging and its sterility.

[0093] Remove the assembled puncture unit (the puncture needle core is already placed inside the puncture sheath), slide the depth limiter on the puncture sheath to the preset depth (e.g., 15mm) and lock it.

[0094] Check the balloon catheter: Confirm that the balloon is not damaged, inject and aspirate a small amount of normal saline or methylene blue solution into the inflation port to verify that the balloon can inflate and deflate normally.

[0095] Step 2: Establishing a channel through puncture:

[0096] In the event of pulmonary artery rupture and bleeding during surgery, the surgeon can use non-invasive grasping forceps to stabilize and expose the target pulmonary artery under thoracoscopy.

[0097] Hold the puncture device with a pen-like grip and select an area on the anterior wall of the blood vessel that is free of branches and calcification as the puncture point.

[0098] Gently and steadily insert the needle into the blood vessel wall at an angle of 30-45° to the blood vessel axis.

[0099] Once you feel a breakthrough and see blood flowing smoothly from the tip of the puncture needle (confirming that it has entered the true lumen of the blood vessel), stop inserting the needle.

[0100] Hold the puncture sheath in place with one hand and slowly withdraw the puncture needle core with the other.

[0101] At this point, the cannula hemostatic valve can prevent a large amount of blood from gushing out, while the cannula is pushed forward 2-3mm to ensure that its blunt tip is completely inserted into the blood vessel lumen.

[0102] Step 3: Insertion of balloon catheter

[0103] The prepared balloon catheter is gently inserted through the hemostatic valve at the end of the puncture sheath, and the balloon is pushed to the target occlusion position.

[0104] Step 4: Balloon inflation and blood flow cessation

[0105] Draw methylene blue solution into the balloon's rated volume (e.g., 0.15 ml) using a 1 ml syringe to remove air.

[0106] Securely connect the syringe to the Luer connector of the balloon catheter inflation port.

[0107] Slowly and evenly push the syringe until you encounter significant resistance or the rated volume has been injected, at which point the balloon will inflate within the blood vessel.

[0108] Under fluoroscopic examination, the balloon was observed to be a regular spindle shape, confirming that it adhered well to the blood vessel wall.

[0109] Immediately, it is visible that the blood flow to the distal end of the target pulmonary artery is completely blocked, and bleeding in the surgical field stops.

[0110] Step 5: Hemostasis and subsequent procedures

[0111] In a clear, bloodless surgical field, the pulmonary artery rupture was carefully and precisely repaired using vascular sutures.

[0112] After the repair is completed, slowly withdraw the syringe to completely deflate the balloon.

[0113] After observing that there is no active bleeding at the original rupture site, the balloon catheter is gently and completely withdrawn.

[0114] Finally, withdraw the puncture sheath. The puncture site usually does not require special treatment or may have slight bleeding. Applying gentle pressure with gauze for a few minutes will stop the bleeding.

[0115] Step 6: Optional blocking effect test

[0116] If it is necessary to test for bleeding at the resected lung tissue stump, the balloon can be re-inflated to block blood flow for observation. This procedure can be repeated as needed to ensure surgical quality.

[0117] The above are preferred embodiments of the present invention. Those skilled in the art can make various modifications or improvements based on these embodiments. Without departing from the overall concept of the present invention, such modifications or improvements should fall within the scope of protection claimed by the present invention.

Claims

1. A pulmonary artery balloon occlusion hemostasis device for lung cancer surgery, characterized in that: The assembly includes a puncture component and a balloon catheter assembly (3); the puncture component includes a puncture needle core (1) and a puncture sheath (2); a limiter (203) is fitted onto the puncture sheath (2), and the sheath body is provided with a sheath scale (202). The depth of insertion of the puncture sheath (2) into the pulmonary artery is determined by adjusting the position of the limiter (203) on the sheath scale (202); the puncture needle core (1) is inserted into the puncture sheath (2), and its tip extends out of the puncture sheath (2) for puncture. The balloon catheter assembly (3) includes a balloon catheter (302) and a balloon (301) sleeved on its outside. The balloon catheter (302) can be inserted into the puncture sheath (2) and the balloon (301) can be extended out of the puncture sheath (2). The proximal end of the balloon catheter (302) is connected to a medical three-way stopcock or directly to a syringe. The proximal end of the puncture sheath (2) is provided with a puncturable silicone membrane (205) to prevent blood backflow when the puncture needle (1) and the balloon catheter (302) are withdrawn.

2. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The puncture needle core (1) is made of medical stainless steel. The puncture needle core (1) has two specifications. One is suitable for thoracoscopic surgery, with a length of 350mm-450mm, which makes it convenient for the surgeon to perform pulmonary artery puncture at the location of the puncture site. The other is suitable for open surgery, with a length of 120mm, which makes it convenient for the surgeon to directly touch the pulmonary artery by hand to perform puncture.

3. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The tip of the puncture sheath (2) is a blunt-tipped structure made of soft polymer. Its function is to minimize the stimulation and damage to the vascular endothelium of the tip of the puncture sheath (2) after the puncture needle core (1) is pulled out, thereby reducing the risk of thrombosis.

4. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The sheath scale (202) is a precision depth scale in millimeters, which, together with the limiter (203), provides the operator with intuitive feedback on the puncture depth.

5. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The limiter (203) is a mechanical buckle or knob mechanism that can slide and lock onto the sheath tube.

6. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The puncturable silicone membrane (205) is located at the end of the cannula and uses a puncturable silicone membrane-type one-way valve. It tightens after the needle is removed. Its function is to prevent blood backflow when inserting or withdrawing the balloon catheter, maintain the cleanliness of the surgical field, and ensure that gas does not leak through the cannula.

7. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 1, characterized in that: The balloon catheter (302) is a flexible multilayer composite tube made of polymer material with embedded metal braided mesh; the balloon (301) is made of highly compliant medical-grade transparent silicone or polyurethane, with a rated blocking diameter ranging from 3 mm to 30 mm.

8. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 7, characterized in that: The balloon catheter (302) has an inlet port located at the tail end of the balloon catheter (302) and a self-sealing valve that can be quickly connected to a standard syringe Luer connector or a medical tee.

9. The pulmonary artery balloon occlusion hemostasis device for lung cancer surgery as described in claim 8, characterized in that: The balloon catheter (302) controls the inflation and deflation of the balloon (301) by injecting a predetermined volume of methylene blue solution; a label may be provided next to the inlet port to indicate the rated volume and maximum recommended pressure of the balloon (301).

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