Transcatheter intracardiac space occupying resection device

Abstract

The utility model discloses a transcatheter intracardiac space occupying resection device which comprises a sheathing canal, a catheter and a guide wire. The occupied space storage mechanism is arranged in the sheath tube and is used for fixing and temporarily storing occupied spaces under the guidance of the sheath tube; and the occupying capturing and cutting mechanism is arranged in the sheath tube, connected with the occupying storage mechanism and used for capturing and cutting occupying. By puncturing the blood vessel, conveying the working guide wire and the working sheathing canal, releasing the capturing system and fixing and cutting the space-occupying lesion in the heart cavity by virtue of the negative pressure system, the minimally invasive and accurate excision of the space-occupying lesion is realized, the operation is simple and convenient, and the risk of tumor dissemination during the space-occupying excision is reduced.

Description

Technical Field

[0001] The utility model belongs to the field of medical devices, and relates to a device for removing intracardiac space-occupying lesions, in particular to a transcatheter intracardiac space-occupying lesion removal device that can avoid the surgical trauma caused by thoracotomy and extracorporeal circulation. Background Art

[0002] Intracardiac space-occupying lesions, such as myxomas, lipomas, elastofibromas, etc., are relatively common and actively treated disease states in heart diseases. At present, the main treatment methods for these diseases still rely on traditional surgical resection. During the operation, doctors need to stop the heart under the assistance of extracorporeal circulation so as to directly observe and remove these space-occupying lesions. Although this treatment method has significant effects, it brings great trauma, slow postoperative recovery, and may cause a series of perioperative complications, such as blood transfusion requirements, fever, wound pain, etc., bringing additional pain and burden to patients.

[0003] In order to relieve the pain of patients and shorten the recovery time, the medical community has been exploring minimally invasive surgical treatment methods. Against this background, the University of Washington Medical Center once tried to use the intravascular retrieval system launched by ONOCOR to remove myxomas in the heart through percutaneous fluoroscopy technology. However, this system has obvious limitations. Its operation process is complex and it needs to be used in conjunction with an endoscopic snare, increasing the surgical difficulty and time. In addition, the basket woven with nitinol wire may cause tumor fragments to spread when crushing the tumor, increasing the risk of postoperative recurrence and metastasis.

[0004] Nevertheless, this clinical attempt still provides important inspiration and reference for the development of transcatheter cardiac space-occupying lesion resection technology. It proves the feasibility of removing space-occupying lesions by entering the heart cavity through catheter technology, providing a direction for future research and innovation.

[0005] Existing resection devices have no effective minimally invasive treatment means and instruments for intracardiac space-occupying lesions. Traditional resection instruments bring great trauma to patients, slow postoperative recovery, and may cause a series of perioperative complications, such as blood transfusion requirements, fever, wound pain, etc., bringing additional pain and burden to patients. Summary of the Utility Model

[0006] In order to overcome the above defects of the intracardiac space-occupying lesion resection device currently used in hospitals clinically, based on long-term clinical practice and experience, the designer has developed a transcatheter intracardiac space-occupying lesion resection device with a new structure, which preferably solves the above problems, is more minimally invasive than the traditional surgical method, and can avoid the complex process and tumor dissemination risk of the existing intravascular retrieval system, making the operation more minimally invasive, safe and effective. Specifically, the utility model includes the following specific solutions:

[0007] A transcatheter intracardiac mass resection device, comprising: a sheath for providing support and guidance for a catheter and a guide wire;

[0008] A mass storage mechanism disposed within the sheath for fixing and temporarily storing a mass under the guidance of the sheath;

[0009] A mass capture and cutting mechanism disposed within the sheath and connected to the mass storage mechanism for capturing and cutting the mass;

[0010] The mass capture and cutting mechanism includes a capture member connected to the mass storage mechanism. The capture member is used to control the mass storage mechanism to tighten and wrap the mass, and the capture member cuts and removes the mass.

[0011] Similar to the conventional sheath used clinically at present, the above-mentioned sheath is connected to a negative pressure system to provide negative pressure adsorption.

[0012] The above-mentioned mass storage mechanism includes: a negative pressure catheter disposed within the sheath for connecting to a negative pressure system and providing negative pressure; a storage cavity main body connected to one end of the negative pressure catheter, and the capture member is connected to the opening edge of the storage cavity main body. The storage cavity main body is used to wrap and store the mass.

[0013] The above-mentioned storage cavity main body is made of braided nitinol wire to ensure its strength and can be retracted into the sheath.

[0014] Similarly, the above-mentioned mass storage mechanism further includes: a connecting pipe connected between the negative pressure catheter and the storage cavity main body for providing a flexible connection between the storage cavity main body and the negative pressure catheter.

[0015] In one embodiment, the above-mentioned storage cavity main body includes: a storage cavity main body; a sealing layer as a lining connected within the storage cavity main body. One end of the connecting pipe penetrates through the sealing layer, and the sealing layer is used to ensure the airtightness of the negative pressure system.

[0016] The storage cavity main body is woven from medical stainless steel wire or nitinol alloy wire.

[0017] The above-mentioned sealing layer serves as a sealed inner liner to ensure the airtightness of the negative pressure system.

[0018] The material of the above-mentioned sealing layer is an elastic material such as rubber or silica gel, or it can also be a non-elastic transparent polymer material such as polyurethane or polyvinyl chloride.

[0019] Preferably, the mass capture and cutting mechanism further includes: a working catheter connected within the sheath, and the capture member is connected to the working catheter; a protective tube connected to one end of the working catheter for protecting the capture member.

[0020] Preferably, one end of the capturing member is connected to the working catheter, and the other end passes through the main body of the storage cavity, penetrates the working catheter, and extends to the outside of the working catheter. When the end of the capturing member located outside the working catheter is twitched, the size of the capturing member can be reduced for excising and separating the mass.

[0021] In an alternative embodiment, the capturing member can be connected to an external power source and, after being energized, act as a resistance coil to perform cutting and separation by electrocautery at the stalk or neck of the mass.

[0022] The above-mentioned negative pressure catheter, connecting tube, working catheter, and protective tube can be made of a polymer material with good biocompatibility, preferably made of silica gel material.

[0023] Preferably, the main body of the storage cavity is in the shape of a sac or a cup, and the capturing member is in the shape of a snare.

[0024] In a preferred embodiment, an opening is formed on the surface of the sealing layer, and the connecting tube is connected inside the opening.

[0025] The transcatheter intracardiac mass excision device of the present utility model has a more concise design. Compared with the current intravascular retrieval system, it is easy to operate and reduces the risk of tumor dissemination. The innovative double-layer structure design of the mass storage cavity ensures both the strength and the sealing performance of the storage cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a three-dimensional structural schematic diagram of the transcatheter intracardiac mass excision device of the present utility model.

[0027] Figure 2 is a three-dimensional structural schematic diagram of the transcatheter intracardiac mass excision device of the present utility model from another perspective.

[0028] Figure 3 is Figure 1 a structural schematic diagram of the mass capturing and cutting mechanism in the shown transcatheter intracardiac mass excision device.

[0029] Figure 4 is Figure 3 a structural schematic diagram of the working catheter and the capturing member in the shown mass capturing and cutting mechanism.

[0030] The reference numerals in the drawings are:

[0031] 1. Sheath tube;

[0032] 2. Mass storage mechanism; 201. Negative pressure catheter; 202. Connecting tube; 203. Main body of the storage cavity; 204. Sealing layer;

[0033] 3. Mass capturing and cutting mechanism; 301. Working catheter; 302. Protective tube; 303. Capturing member. Detailed implementation manners

[0034] For intracardiac space-occupying lesions, such as myxoma, lipoma, elastofibroma and other disease states, the current main treatment method is still mainly surgical resection of the heart under extracorporeal circulation assistance. Usually, extracorporeal circulation assistance is required, and the space-occupying lesion is directly removed under cardiac arrest.

[0035] The present utility model is a new concept proposed to overcome the harm caused to patients by directly removing space-occupying lesions under extracorporeal circulation assistance and cardiac arrest. According to the designer's many years of clinical experience and observation, during the process of dealing with space-occupying lesions, the establishment of extracorporeal circulation requires complex surgical techniques and precise equipment operations, including arteriovenous intubation, pump pressure control, etc. During the process of blocking the aorta and myocardial protection, if a three-lumen tube with retrograde femoral artery intubation is used, there are operational difficulties. For example, the three-lumen tube is relatively thick, and retrograde intubation needs to pass through the aortic root, which may cause damage to the root. During extracorporeal circulation, excessive negative pressure may increase blood damage, generate the risk of micro-air embolism, and may cause the vena cava at the intubation opening site to adhere to the wall, aggravating insufficient drainage. The balloon blocking the aorta has a risk of slipping, which may lead to emergencies during the operation. During cardiac arrest, although myocardial injury can be reduced by perfusing myocardial protective fluid, long-term cardiac arrest may still have an adverse impact on cardiac function. During extracorporeal circulation, if the drainage is insufficient or the pump pressure is too high, it may lead to a low perfusion flow rate, affecting cerebral blood supply and oxygenation, and increasing the risk of brain injury. Cardiac arrest and extracorporeal circulation may increase the postoperative recovery time, and patients need longer-term monitoring and rehabilitation. Extracorporeal circulation surgery requires high-cost medical equipment and the support of a professional team, increasing the treatment cost. Due to the surgical complexity and postoperative recovery needs, patients may need to bear more physical and psychological pressures.

[0036] This design focuses on the above problems and proposes improvements: the resection of intracardiac space-occupying lesions is achieved through catheter technology, which has less trauma and a faster recovery speed compared with traditional surgical operations. The cutting mechanism can precisely control the cutting force and range, avoiding damage to surrounding normal tissues; the recovery mechanism can safely and effectively recover the excised diseased tissues, avoiding the risk of tumor dissemination. The entire surgical process is carried out under the guidance of catheter technology, with simple and rapid operation, improving the surgical efficiency.

[0037] In this article, the term "transcatheter intracardiac space-occupying lesion resection device" may sometimes also be referred to as "space-occupying lesion resection device". For the sake of simplicity in description, it may also be abbreviated as "resection device", and they represent the same meaning and can be used interchangeably.

[0038] In this article, terms such as "front, back, up, down" do not constitute an absolute spatial relationship limitation, but are just a concept of relative position, which is easily understood by those skilled in the art.

[0039] The technical solution of the present utility model will be described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments; and the structures shown in the drawings are only schematic and do not represent actual objects. It should be noted that based on these embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art belong to the scope of protection of the present application. Moreover, without conflict, the embodiments in the present utility model and the features and technical solutions in the embodiments can be combined with each other.

[0040] It should be understood that similar reference numerals and letters represent similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0041] Embodiment

[0042] Please refer to Figures 1-4 , the transcatheter intracardiac mass resection device of the present utility model specifically includes:

[0043] A sheath tube 1, which is used to provide support and guidance for the catheter and guide wire. The sheath tube 1 is usually made of medical-grade polymers, such as polytetrafluoroethylene or polyurethane. These materials have good biocompatibility and sufficient mechanical strength. The sheath tube 1 can be designed in versions with different lengths, diameters, and curvatures to adapt to different surgical needs and patient anatomies. In addition to providing support and guidance for the catheter and guide wire, the sheath tube 1 can also serve as a channel for drug delivery or fluid extraction;

[0044] A mass storage mechanism 2, which is arranged in the sheath tube 1 and is used to fix and temporarily store the mass under the guidance of the sheath tube 1. During the operation, by connecting to a negative pressure system, the negative pressure catheter 201 creates a negative pressure environment. Under the guidance of the sheath tube 1, the mass lesion is guided into the sac of the storage cavity main body 203. With the action of the negative pressure, the mass lesion is completely and safely stored in the sac. The connecting tube 202 provides a flexible connection between the negative pressure catheter 201 and the storage cavity main body 203 to ensure that the negative pressure can be smoothly transmitted into the sac;

[0045] The space-occupying capturing and cutting mechanism 3 is arranged in the sheath tube 1 and connected to the space-occupying storage mechanism 2, and is used for capturing and cutting the space-occupying. During the operation, the working catheter 301 and the capturing member 303 are sent into the heart cavity together with the storage cavity body 203 under the guidance of the sheath tube 1. When the space-occupying lesion is located, its size is reduced by the pumping operation, and the capturing member 303 drives the storage cavity body 203 to cover the pedicle or neck of the space-occupying lesion, so as to capture and cut the space-occupying lesion. The protective tube 302 protects the capturing member 303 and the patient from damage during the operation. After the cutting is completed, the space-occupying lesion is stored in the bag of the storage cavity body 203 through the action of the negative pressure system for subsequent processing;

[0046] The placeholder capturing and cutting mechanism 3 includes a capturing member 303 , which is connected to the placeholder storage mechanism 2 . The capturing member 303 is used to control the placeholder storage mechanism 2 to tighten and wrap the placeholder, and the capturing member 303 cuts and removes the placeholder.

[0047] It should be noted that the terms "comprises", "includes" or any other variations thereof in this document are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements that have been explicitly listed, but also other elements that are not explicitly listed.

[0048] These components are described below.

[0049] The placeholder storage mechanism 2 includes: a negative pressure catheter 201, which is arranged in the sheath tube 1 and is used to connect to a negative pressure system and provide negative pressure. The negative pressure system can be an independent device, which is connected to the negative pressure catheter 201 in the sheath tube 1 through a catheter to generate and maintain a negative pressure environment;

[0050] The storage cavity body 203 is connected to one end of the negative pressure conduit 201. The capture member 303 is connected to the opening edge of the storage cavity body 203. The storage cavity body 203 is used to wrap and store the placeholder. The design of the storage cavity body 203 should ensure that the placeholder can completely and safely enter and be stored in the pouch under the action of negative pressure. The pouch can be designed to be foldable or retractable to accommodate placeholders of different sizes.

[0051] The connecting tube 202 is connected between the negative pressure catheter 201 and the storage chamber body 203, and is used to provide a soft connection between the storage chamber body 203 and the negative pressure catheter 201. The connecting tube 202 is soft enough to avoid causing discomfort or damage to the patient during the operation. It should also have good sealing performance to ensure the effectiveness of the negative pressure system.

[0052] The storage cavity body 203 includes: a sealing layer 204 as a lining, which is connected inside the storage cavity body 203. One end of the connecting pipe 202 penetrates through the sealing layer 204, and the sealing layer 204 is used to ensure the airtightness of the negative pressure system.

[0053] The occupancy capture cutting mechanism 3 includes: a working catheter 301, which is connected inside the sheath 1. The capture member 303 is connected to the working catheter 301. In addition to connecting the capture member 303, the working catheter 301 can also serve as a channel for delivering drugs, physiological saline or other fluids.

[0054] A protective tube 302 is connected to one end of the working catheter 301 for protecting the capture member 303. The protective tube 302 can be telescopic or rotatable so as to adjust the position and angle of the capture member 303 as needed during the operation.

[0055] One end of the capture member 303 is connected to the working catheter 301, and the other end passes through the storage cavity body 203 and then penetrates through the working catheter 301 and extends to the outside of the working catheter 301. When the end of the capture member 303 located outside the working catheter 301 is twitched, the size of the capture member 303 can be reduced for wrapping tightly around the storage cavity body 203 and excising and separating the occupancy. The capture member 303 can be designed with different sizes and shapes to adapt to occupancies of different sizes and shapes. Medical thread can be used. The loop-like structure is flexible enough to accurately loop around the stalk or neck of the occupancy. The capture member 303 is made of metal materials such as medical-grade stainless steel or nitinol alloy to ensure its sufficient strength and durability.

[0056] In another alternative embodiment, the capture member 303 can be connected to an external power source (not shown). After being energized, it acts as a resistance coil to perform cutting and separation by electrocautery at the stalk or neck of the occupancy.

[0057] In another alternative embodiment, the capture member 303 and the storage cavity body 203 adopt a separated layout. The capture member 303 can work independently. After the storage cavity body 203 wraps around and adsorbs the occupancy, the capture member 303 can be used alone to excise the occupancy.

[0058] The storage cavity body 203 is in the shape of a sac or a cup. In addition to the sac shape, the storage cavity body 203 can also be designed into other shapes, such as spherical, conical or flat, to meet different surgical needs. The storage cavity body 203 is woven from medical stainless steel wire or nitinol alloy wire. For example, the material of the storage cavity body 203 is woven nitinol wire, which has good biocompatibility and sufficient elasticity to ensure that it can be fully expanded and store the occupancy under negative pressure.

[0059] The capture member 303 is in the shape of a loop.

[0060] An opening is formed on the surface of the sealing layer 204, and the connecting pipe 202 is connected inside the opening. The sealing layer 204 is usually made of elastic materials such as rubber or silica gel, or can also be made of inelastic transparent polymer materials such as polyurethane or polyvinyl chloride to ensure good sealing performance. The opening formed on the surface of the sealing layer 204 should be closely fitted with the connecting pipe 202 to ensure the airtightness of the negative pressure system. At the same time, an additional sealing structure such as an O-ring or a gasket can be provided at the opening.

[0061] When the utility model is in use, according to the specific position and size of the space-occupying lesion, plan the surgical path, determine the puncture access vessel, and prepare the corresponding surgical instruments and equipment;

[0062] Puncture access vessel: According to the surgical plan, puncture the corresponding access vessel to establish a surgical channel;

[0063] Deliver the working guide wire: Through the punctured vascular channel, deliver the working guide wire to the vicinity of the space-occupying lesion in the heart cavity. The guide wire plays a guiding and supporting role and provides a path for the delivery of subsequent instruments;

[0064] Deliver the working sheath 1 along the guide wire: Under the guidance of the working guide wire, gradually deliver the sheath 1 to the vicinity of the space-occupying lesion in the heart cavity. The sheath 1 serves as a carrier for surgical instruments and can protect the surrounding tissues from damage;

[0065] Release the capture system: Under the guidance of the sheath 1, gradually release the negative pressure catheter 201, the storage cavity main body 203, the working catheter 301 and the capture member 303, and adjust the position and angle of the storage cavity main body 203 so that it can accurately capture the space-occupying lesion; after confirming that the position of the storage cavity main body 203 is correct, make it wrap the space-occupying lesion;

[0066] Fix the space-occupying lesion with the negative pressure system: Connect the negative pressure system and adsorb and fix the space-occupying lesion in the storage cavity main body 203 by negative pressure suction to prevent it from moving or falling off during the operation;

[0067] Tighten and cut operation: After confirming that the space-occupying lesion is firmly fixed, pull the end of the capture member 303 located outside the working catheter 301, tighten the capture member 303 and control the tightening of the opening edge of the storage cavity main body 203. The capture member 303 and the storage cavity main body 203 surround the stalk or neck of the space-occupying lesion to ensure that the space-occupying lesion is completely surrounded, reduce the size of the capture member 303, cut and remove the space-occupying lesion, ensure that the cutting process is stable and accurate, and avoid damaging the surrounding tissues;

[0068] Collect the space-occupying tissue: After cutting, use the negative pressure system to collect the cut space-occupying tissue into the sheath 1 to ensure that the space-occupying tissue is completely collected and prevent it from remaining in the heart cavity. At this time, the storage cavity main body 203 always tightly wraps the space-occupying lesion;

[0069] Removing the space-occupying tissue: After confirming that the space-occupying tissue is completely accommodated, remove the sheath 1 together with the space-occupying tissue from the vascular channel. Pay attention to keeping the sheath 1 stable during the removal process to avoid damage to surrounding tissues.

[0070] Compared with traditional open-chest surgery, minimally invasive resection of space-occupying lesions in the cardiac cavity significantly reduces surgical trauma, pain and recovery time for patients.

[0071] By puncturing the access blood vessels, delivering the working guide wire and working sheath, and releasing the capture system, the space-occupying lesions in the heart cavity can be accurately and quickly located and captured, thereby improving the accuracy and success rate of the operation.

[0072] With the help of the negative pressure system to fix the space-occupying lesions, the movement or fall-off of the space-occupying lesions during the operation can be effectively prevented, reducing the surgical risks. The minimally invasive operation also reduces the damage to the surrounding tissues and further improves the safety of the operation.

[0073] This solution can complete the removal of intracardiac space-occupying lesions in a short time, improving the efficiency of the operation. In addition, since the surgical trauma and recovery time are reduced, patients can return to normal life and work more quickly, improving their quality of life.

[0074] This protocol is applicable to various types of intracardiac space-occupying lesions, including but not limited to tumors, cysts, etc. At the same time, due to the use of minimally invasive surgery, it is also highly applicable to patients who are elderly, weak, or have other diseases.

[0075] The space-occupying lesions removed through this protocol can be completely contained and removed, facilitating subsequent pathological examination and treatment.

[0076] The above is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical solution and improved ideas of the present invention within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention.

Claims

1. A transcatheter intracardiac space-occupying resection device, characterized in that: include: A sheath (1) is used to provide support and guidance for the catheter and the guide wire; A placeholder storage mechanism (2) is arranged in the sheath tube (1) and is used to fix and temporarily store the placeholder under the guidance of the sheath tube (1); A space-occupying capturing and cutting mechanism (3), arranged in the sheath tube (1), connected to the space-occupying storage mechanism (2), and used for capturing and cutting the space-occupying; The place-occupying capture and cutting mechanism (3) comprises a capture member (303), the capture member (303) is connected to the place-occupying storage mechanism (2), the capture member (303) is used to control the place-occupying storage mechanism (2) to tighten and wrap the place-occupying device, and the capture member (303) cuts and removes the place-occupying device.

2. The transcatheter intracardiac space-occupying resection device according to claim 1, characterized in that: The placeholder storage mechanism (2) comprises: A negative pressure catheter (201), arranged in the sheath tube (1), used for connecting to a negative pressure system and providing negative pressure; The storage cavity body (203) is connected to one end of the negative pressure conduit (201), and the capture member (303) is connected to the opening edge of the storage cavity body (203). The storage cavity body (203) is used for wrapping and storing placeholders.

3. The transcatheter intracardiac space-occupying resection device according to claim 2, characterized in that: The placeholder storage mechanism (2) further comprises: The connecting tube (202) is connected between the negative pressure conduit (201) and the storage chamber body (203) and is used to provide a soft connection between the storage chamber body (203) and the negative pressure conduit (201).

4. The transcatheter intracardiac space-occupying resection device according to claim 3, characterized in that: The storage cavity body (203) comprises: The sealing layer (204) serving as an inner lining is connected inside the storage cavity body (203), one end of the connecting pipe (202) passes through the sealing layer (204), and the sealing layer (204) is used to ensure the airtightness of the negative pressure system.

5. The transcatheter intracardiac space-occupying resection device according to claim 2, characterized in that: The place-occupying capture and cutting mechanism (3) further comprises: A working catheter (301) is connected inside the sheath tube (1), and the capture member (303) is connected to the working catheter (301); The protection tube (302) is connected to one end of the working conduit (301) and is used to protect the capture member (303).

6. The transcatheter intracardiac space-occupying resection device according to claim 5, characterized in that: One end of the capture member (303) is connected to the working conduit (301), and the other end passes through the storage chamber body (203) and then penetrates the working conduit (301), and extends to the outside of the working conduit (301). When the end of the capture member (303) located outside the working conduit (301) is pulled, the size of the capture member (303) can be reduced for cutting and separating the space-occupying part.

7. The transcatheter intracardiac space-occupying resection device according to claim 2, characterized in that: The storage cavity body (203) is in a pouch shape or a cup shape.

8. The transcatheter intracardiac space-occupying resection device according to claim 1, characterized in that: The capture member (303) is in the shape of a snare.

9. The transcatheter intracardiac space-occupying resection device according to claim 4, characterized in that: An opening is formed on the surface of the sealing layer (204), and the connecting pipe (202) is connected in the opening.

10. The transcatheter intracardiac space-occupying resection device according to claim 4, characterized in that: The sealing layer (204) is made of one of rubber, silicone, polyurethane or polyvinyl chloride.

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