An intracardiac bendable occlusion umbrella delivery sheath assembly and use method thereof

Abstract

The present invention relates to the technical field of medical devices, and specifically discloses an intracardiac bendable occluding umbrella delivery sheath assembly and a method of use. The intracardiac bendable occluding umbrella delivery sheath assembly comprises: an outer sheath and an inner sheath; the outer sheath has a first through hole, including a first delivery channel, and the end of the first delivery channel has an adjustment portion; the inner sheath includes a second delivery channel, and the second delivery channel is connected to a bendable bending portion, the inner sheath is inserted into the first through hole of the outer sheath, and the relative position of the adjustment portion and the bending portion in the axial direction is adjusted, and the inner sheath is pushed against the posterior wall of the heart to adjust the angle of the inner sheath. The angle can be arbitrarily adjusted between 0-90° according to the structure of the heart of each different patient and the location of various defects, fistulas, and leaks, so as to successfully implant an occluding umbrella of suitable model.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intracardiac bendable occluding umbrella delivery sheath assembly and a use method thereof. Background Art

[0002] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention, and should not necessarily be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.

[0003] Minimally invasive surgery is not only less traumatic but also less risky, less expensive, and requires less hospitalization. It is currently widely used in clinical practice and is well received by patients. Various congenital heart defects, fistulas, and residual leakage after various valvular disease replacement surgeries can all be considered for occlusion surgery using minimally invasive techniques.

[0004] The operation must be completed by delivering the occluder to the defect or various fistulas or leaks with the help of a sheath assembly. However, the traditional occluder sheath assembly for cardiac surgery is made of hard plastic material, and the angle cannot be controlled. The operation often fails due to the poor angle, and the operation is replaced by a large open chest surgery, which brings great trauma and risks to the patient. Summary of the invention

[0005] In view of the deficiencies in the prior art, the purpose of an embodiment of the present invention is to provide a bendable intracardiac occluder umbrella delivery sheath assembly, which solves the defect that the angle of the sheath cannot be adjusted in the heart. The angle can be adjusted arbitrarily between 0-90° according to the structure of the heart of each different patient and the locations of various defects, fistulas, and leaks, thereby successfully implanting an occluder umbrella of suitable model and avoiding the patient's need for a large thoracotomy.

[0006] In order to achieve the above objectives, the embodiments of the present invention provide the following technical solutions:

[0007] A bendable occluding umbrella delivery sheath assembly in the heart comprises: an outer sheath and an inner sheath; the outer sheath has a first through hole therein, comprising a first delivery channel, the end of the first delivery channel has an adjustment portion; the inner sheath comprises a second delivery channel, the second delivery channel is connected to a bendable bending portion, the inner sheath is inserted into the first through hole of the outer sheath, the relative axial position of the adjustment portion and the bending portion is adjusted, and the inner sheath is pushed against the posterior wall of the heart to adjust the angle of the inner sheath.

[0008] In another preferred embodiment, a first connector is provided at one end of the first delivery channel of the outer sheath tube away from the adjusting portion, and the diameter of the first connector is larger than the diameter of the first delivery channel; a second connector is provided at one end of the second delivery channel of the inner sheath tube away from the bending portion, and the diameter of the second connector is larger than the diameter of the second delivery channel.

[0009] In another preferred embodiment, a protective film is disposed on the outer side of the bending portion.

[0010] In another preferred embodiment, the adjusting portion and the bending portion are made of metal and are used for visualization under X-ray and ultrasound.

[0011] An embodiment of the present invention also provides a method for using the above-mentioned intracardiac bendable occlusion umbrella delivery sheath assembly, including: adjusting the relative positions of the inner sheath and the outer sheath, releasing the large umbrella disc, bending the inner sheath, adjusting the bending angle of the inner sheath and the direction of the inner sheath, releasing the small umbrella disc, and recovering the sheath assembly.

[0012] In another preferred embodiment, adjusting the relative position of the inner sheath tube and the outer sheath tube includes: pushing or pulling the adjusting portion relative to the bending portion to change the bending position and length of the bending portion.

[0013] In another preferred embodiment, bending the inner sheath tube comprises: pushing the outer sheath tube and the inner sheath tube simultaneously, and after the large umbrella disc is pressed against the posterior wall of the left atrium, continuing to push forward to bend the inner sheath tube.

[0014] In another preferred embodiment, adjusting the bending angle of the inner sheath tube includes: adjusting the bending angle by adjusting the propulsion force.

[0015] In another preferred embodiment, adjusting the orientation of the inner sheath tube includes: changing the orientation of the inner sheath tube by rotating the inner sheath tube.

[0016] In another preferred embodiment, if the operation is unsuccessful, the small and large umbrella discs are retrieved in sequence and the operation is repeated again.

[0017] One or more technical solutions provided in the embodiments of the present invention have at least the following technical effects or advantages:

[0018] 1. The present invention adjusts the relative positions of the adjustment part and the bending part by cooperating with the inner and outer sheaths, and adjusts the appropriate bending angle according to different heart structures, so that the angle of the occluding umbrella is directly opposite to the atrial septal defect, thereby avoiding the problem of the occluding umbrella falling out of the atrial septal defect and causing the operation failure.

[0019] 2. The sheath assembly of the present invention can be adjusted between 0-90° according to the different heart structures of the patients, which increases the maneuverability and the success rate of the operation compared to the sheath with a fixed angle. Moreover, some sheaths with a fixed angle have too large an angle and are difficult to advance in a linear venous conduit. It is very difficult to enter the right atrium through the femoral vein. After the occlusion is completed, it is also difficult to pull out the sheath. The sheath of the present invention can smoothly enter the right atrium through the vein by entering the vein in a straight line. The angle can be adjusted arbitrarily in the atrium. After the occlusion is completed, the inner sheath is retracted so that the sheath exits the vein in a straight line again, which reduces the difficulty of the operation.

[0020] 3. The sheath tube assembly of the present invention avoids the problem of difficulty in pushing and recovering caused by the rough surface of the groove of the bending part by arranging a protective film outside the bending part.

[0021] 4. The sheath assembly of the present invention adopts vein or artery puncture to enter the heart through the vein or artery without puncturing the heart, which causes little trauma. It is suitable for the treatment of various congenital heart diseases with defects and fistulas and the treatment of complications after acquired heart disease surgery. It is simple, convenient, practical, low-cost and easy to promote clinically. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings in the specification, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0023] Figure 1 It is a schematic diagram of a sheath tube in the prior art;

[0024] Figure 2 is a schematic diagram of the assembly of a sheath tube assembly according to an embodiment of the present invention;

[0025] Figure 3 is a schematic diagram of an outer sheath tube of a sheath tube assembly according to an embodiment of the present invention;

[0026] Figure 4 Schematic diagram of an inner sheath tube of a sheath tube assembly according to an embodiment of the present invention;

[0027] Figure 5 is an enlarged view of the bending portion of the inner sheath tube according to an embodiment of the present invention;

[0028] Figure 6 is a schematic diagram of the bending process of the sheath tube assembly according to an embodiment of the present invention;

[0029] Figure 7 is a schematic diagram of a sheath tube assembly according to an embodiment of the present invention being successfully placed into an occluding umbrella after being bent;

[0030] Figure 8 is a schematic diagram of the recovery of the sheath tube assembly according to an embodiment of the present invention;

[0031] In the figure: 01, left atrium; 02, right atrium; 03, inferior vena cava; 04, superior vena cava; 05, atrial septal defect; 1, outer sheath; 11, first connector; 12, first delivery channel; 13, adjustment part; 2, inner sheath; 21, second connector; 22, second delivery channel; 23, bending part; 231, protective film; 24, guide part;

[0032] In order to show the positions of various parts, the distances or sizes between them are exaggerated and the schematic diagram is for reference only. DETAILED DESCRIPTION

[0033] For the convenience of description, if the words "up", "down", "left" and "right" appear in the present invention, they only indicate that they are consistent with the up, down, left and right directions of the drawings themselves, and do not limit the structure. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the equipment or components referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention. The terms "install", "connect", "connect", "fix" and the like in the present invention should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral whole; it can be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium, it can be an internal connection between two elements, or an interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the terms in the present invention can be understood according to the specific circumstances.

[0034] As introduced in the background technology, traditional cardiac surgical occlusion umbrella delivery sheath components are made of hard plastic materials, and the angle cannot be controlled. The operation often fails due to the problem of poor angle, so it is changed to open-chest surgery, which brings great trauma and risks to the patient. In order to solve the above technical problems, the present invention proposes a bendable intracardiac occlusion umbrella delivery sheath assembly.

[0035] like Figure 2-Figure 5 As shown, in one embodiment of the present invention, a bendable occluding umbrella delivery sheath assembly within the heart is recorded, comprising: an outer sheath 1 and an inner sheath 2; the outer sheath 1 has a first through hole, comprising a first delivery channel 12, and the end of the first delivery channel 12 has an adjustment portion 13; the inner sheath 2 comprises a second delivery channel 22, and the second delivery channel 22 is connected to a bendable bending portion 23, the inner sheath 2 is inserted into the first through hole of the outer sheath 1, and the relative axial position of the adjustment portion 13 and the bending portion 23 is adjusted, and the inner sheath 2 is pushed against the posterior wall of the heart to adjust the angle of the inner sheath 2.

[0036] The present invention adjusts the relative positions of the adjustment part and the bending part 23 by cooperating with the inner and outer sheaths 1, and adjusts the appropriate bending angle according to different heart structures, so that the angle of the occluding umbrella is directly opposite to the atrial septal defect 05, thereby avoiding the problem of the occluding umbrella falling out of the atrial septal defect 05 and causing the operation failure.

[0037] The sheath tube assembly of the present invention can be adjusted arbitrarily between 0-90 ° according to the different cardiac structures of the patient (such as the height, left deviation, right deviation, size of the defect, etc.), which increases the controllability and the success rate of the operation compared to the sheath tube with a fixed angle. Moreover, some sheath tubes with fixed angles have too large an angle, and it is difficult to advance in a linear venous conduit, and it is very difficult to enter the right atrium 02 through the femoral vein. In addition, after the blocking is completed, it is also difficult to pull out the sheath tube. The sheath tube of the present invention enters the vein in a linear manner (without bending the sheath tube) and can smoothly enter the right atrium 02 through the vein. The angle can be adjusted arbitrarily in the atrium. After the blocking is completed, the inner sheath tube 2 is retracted to allow the sheath tube to exit the vein in a linear manner again, which reduces the difficulty of the operation.

[0038] The first connector 11 of the outer sheath tube 1 allows the inner sheath tube 2 to be easily inserted into the outer sheath tube 1; the first delivery channel 12 of the outer sheath tube 1 is made of hard plastic, and the adjustment part 13 is made of metal; the adjustment part 13 of the outer sheath tube 1 can be visualized under X-ray and cardiac ultrasound, so that the operator can adjust the relative position of the adjustment part 13 within the bending part of the inner sheath tube 2 under direct vision guided by X-ray and cardiac ultrasound to change the bending position of the bending part, thereby changing the length of the bent inner sheath tube 2 according to the patient's needs.

[0039] The second connector 21 of the inner sheath tube 2 can input the occluding umbrella and the steel cable connecting the occluding umbrella. The second delivery channel 22 is made of hard plastic. The bending part is the key part of the bending. It is made of metal and can be bent in any direction. It is covered with a soft plastic protective film 231 to not restrict bending. The bending part can be developed under X-ray and ultrasound, and the position of the bending is determined by the positioning of the adjustment part 13 of the outer sheath tube 1. The bending part is connected to the hard plastic guide part 24. During the operation, the guide part 24 can be bent together with part of the bending part, and the length of the bending is determined by the positioning of the adjustment part 13 of the outer sheath tube 1. The function of the guide part 24 is mainly to guide the release direction of the occluding umbrella. The direction of the guide part 24 can be changed by rotating the inner sheath tube 2.

[0040] The metal bending part 23 is covered with a soft plastic protective film 231 to prevent blood from contacting the metal bendable area, because blood contact will form thrombus. In addition, the metal bendable part 23 has grooves. If it is not covered with plastic, the rough surface will form friction, making it difficult to push and recover.

[0041] Introduction to the surgical process: The occluder is a wire mesh structure, dumbbell-shaped (or gourd-shaped) and soft in texture. It is connected by rotating through the central nut and the screw of the steel cable. If the steel cable is covered with a sheath (similar to a straw for cola) and then connected to the occluder, the steel cable can be easily pulled back into the sheath by fixing the sheath, and the large and small umbrella plates can be easily released one by one by pushing the steel cable. During the operation, if the occluder is in place, the occluder can be released by rotating the steel cable in the opposite direction, and then the sheath and steel cable can be withdrawn to complete the operation.

[0042] like Figure 6-8 , the method of using the above sheath tube assembly:

[0043] Puncture the femoral vein, implant a guide wire from the puncture needle to the atrium, withdraw the puncture needle, insert the sheath assembly along the guide wire, and withdraw the guide wire.

[0044] Put the blocking umbrella into the short sheath (not the outer sheath or inner sheath in the present invention), insert it into the inner sheath, push the steel cable, the blocking umbrella will enter the inner sheath, and then withdraw the short sheath. The above process is not the protection content of the present invention, and the means in the prior art can be used.

[0045] Adjust the bending position and length of the inner sheath tube 2: the adjusting portion 13 of the outer sheath tube 1 is pushed forward or pulled out relative to the bending portion of the inner sheath tube 2 to change the bending position and length of the bending portion.

[0046] Bending: After adjusting the relative positions of the adjusting part 13 and the bending part, release the large umbrella plate of the occluding umbrella, push the outer sheath tube 1 and the inner sheath tube 2 forward at the same time, and after the large umbrella plate is pressed against the posterior wall of the left atrium 01, continue to push forward and bend the inner sheath tube 2 (such as Figure 6 By releasing the large umbrella disc and then bending it, the posterior wall of the left atrium 01 can be protected from being punctured by the sheath.

[0047] Adjust the bending angle: Under X-ray and ultrasound, the bending angle can be adjusted by adjusting the pushing force as needed. If the bending angle is too large due to excessive force, the inner sheath tube 2 can be fixed or pulled back, and the outer sheath tube 1 can be pushed hard to reduce the bending angle. At the same time, the direction of the guide part 24 can be changed by rotating the inner sheath tube 2 to achieve the ideal angle.

[0048] Release the small umbrella disc: Release the small umbrella disc, put the large umbrella disc into the left atrium 01, and the small umbrella disc into the right atrium 02, clamping the defect like a rivet (such as Figure 7 shown).

[0049] Recover the sheath assembly: release the occluding umbrella, push the outer sheath 1 forward and pull back the inner sheath 2 to reduce the bending angle, and then withdraw the sheath assembly.

[0050] In the prior art, if the sheath head cannot be bent, it is difficult for the large umbrella plate to hook the left atrium 01 side (such as Figure 1 As shown in FIG. 1 , it is easy to slip out of the defect to the right atrium 02, and the operation fails. The present invention can make the large umbrella plate easily hook the left atrium 01 side (as shown in FIG. 1 ). Figure 6 ), if the operation is unsuccessful, pull back the cable to retrieve the small and large umbrella plates in turn and repeat the operation.

[0051] The sheath assembly of the present invention adopts vein or artery puncture to enter the heart through the vein or artery, and does not puncture the heart, which has little trauma. It is suitable for the treatment of various congenital heart diseases with defects and fistulas (such as patent foramen ovale, atrial septal defect, patent ductus arteriosus, atrial septal puncture, etc.) and the treatment of complications after acquired heart disease surgery (such as paravalvular fistula after aortic valve replacement, paravalvular fistula after mitral valve replacement, etc.). It is simple, convenient, practical, low-cost, and easy to promote clinically.

[0052] Although the above describes the specific implementation mode of the present invention in conjunction with the accompanying drawings, it is not intended to limit the scope of protection of the present invention. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art on the basis of the technical solution of the present invention without creative work are still within the scope of protection of the present invention.

Claims

1. A bendable occlusion umbrella delivery sheath assembly in the heart, characterized in that: include: Outer sheath and inner sheath; The outer sheath tube has a first through hole therein, including a first delivery channel, and the end of the first delivery channel has an adjustment portion; The inner sheath tube comprises a second delivery channel, the second delivery channel is connected to a bendable bending portion, the inner sheath tube is inserted into the first through hole of the outer sheath tube, the relative axial position of the adjustment portion and the bending portion is adjusted, and the inner sheath tube is pushed against the posterior wall of the heart to adjust the angle of the inner sheath tube; A protective film is arranged on the outer side of the bending portion; the adjusting portion and the bending portion are made of metal and are used for developing under X-ray and ultrasound; Adjust the relative position of the adjusting portion within the bending portion of the inner sheath tube to change the bending position of the bending portion, thereby changing the length of the bent inner sheath tube according to the patient's needs; the bending position is determined by the positioning of the outer sheath tube adjusting portion, the bending portion is connected to the hard plastic guide portion, the guide portion and part of the bending portion are bent together during the operation, and the bending length is determined by the positioning of the outer sheath tube adjusting portion.

2. The intracardiac bendable occlusion umbrella delivery sheath assembly according to claim 1, characterized in that: A first connector is provided at one end of the first delivery channel of the outer sheath tube away from the adjusting portion, and the diameter of the first connector is larger than the diameter of the first delivery channel; a second connector is provided at one end of the second delivery channel of the inner sheath tube away from the bending portion, and the diameter of the second connector is larger than the diameter of the second delivery channel.

3. The intracardiac bendable occlusion umbrella delivery sheath assembly according to claim 1, characterized in that: The method for using the sheath tube assembly comprises: Adjust the relative positions of the inner sheath tube and the outer sheath tube, release the large umbrella disc, bend the inner sheath tube, adjust the bending angle and direction of the inner sheath tube, release the small umbrella disc, and recycle the sheath tube assembly.

4. The intracardiac bendable occlusion umbrella delivery sheath assembly as claimed in claim 3, characterized in that: Adjusting the relative position of the inner sheath tube and the outer sheath tube includes: pushing or pulling the adjusting portion relative to the bending portion to change the bending position and length of the bending portion.

5. The intracardiac bendable occlusion umbrella delivery sheath assembly as claimed in claim 3, characterized in that: Bending the inner sheath tube comprises: pushing the outer sheath tube and the inner sheath tube forward simultaneously, and after the large umbrella plate is pressed against the posterior wall of the left atrium, continuing to push forward and bending the inner sheath tube.

6. The intracardiac bendable occlusion umbrella delivery sheath assembly as claimed in claim 3, characterized in that: Adjusting the bending angle of the inner sheath includes: adjusting the bending angle by adjusting the pushing force.

7. The intracardiac bendable occlusion umbrella delivery sheath assembly as claimed in claim 3, characterized in that: Adjusting the direction of the inner sheath tube includes: changing the direction of the inner sheath tube by rotating the inner sheath tube.

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