Controllable bending sheathing canal

Abstract

The utility model provides a bending-controllable sheathing canal, which is used for coronary sinus surgery and comprises a handle, a bending-controllable sheathing canal body and a bending-controllable sheathing canal body. The sheathing canal comprises at least one hollow cavity, the sheathing canal is connected with the handle at the near end, the sheathing canal comprises a transition part and an end part at the far end, the end part comprises a bendable component, and the moving direction of the bendable component is perpendicular to the extending direction of a sheathing canal main body; and one end of the bending control stay wire is arranged in the handle and is connected with the control part, and the other end of the bending control stay wire is connected with the bendable part. By adopting the three-dimensional controllable bent structural design, the problem of rapid construction of the passage from the inferior vena cava to the coronary sinus through the right atrium under the condition of different coronary sinus opening variation is solved. And the end part of the sheath tube is made of a material with relatively low hardness, so that the risk of damaging the inner wall of a blood vessel is reduced when the sheath tube enters the coronary sinus opening.

Description

Technical Field

[0001] The utility model relates to the technical field of medical instruments, in particular to a controllable curved sheath tube used for coronary sinus surgery. Background Art

[0002] The coronary sinus is an important part of the cardiac circulatory system. It is the extended part of the great cardiac vein. It is located in the coronary sulcus between the left atrium and the left ventricle. It is the main entrance for venous return of the heart wall. Various cardiac surgeries can be provided through the coronary sinus. It is the only way for cardiac interventional treatment, such as myocardial protection, targeted drug delivery, and radiofrequency ablation of arrhythmias using retrograde coronary venous perfusion in cardiac surgery. However, the starting part of the coronary sinus is thin and easy to be damaged.

[0003] Chinese utility model patent CN201420355820.8 discloses a controllable bending guide sheath device, including a sheath tube and a control handle, wherein the proximal end of the sheath tube is inserted into the control handle, and an inner tube channel is formed through a Luer interface provided at the end of the control handle, wherein the sheath tube is formed by three layers of inner tube, middle tube and outer tube, which are nested with each other, and the distal end of the sheath tube is a bendable tube section and a soft head end is provided at the distal end, and at the same time, the front end of the tube body of the inner tube and the middle tube are each provided with an inner tube incision and an intermediate tube incision evenly distributed at one end, with a certain length and width, thereby forming a bendable structure. The controllable bending guide sheath device is used for sinus surgery, and is bent into an angle under controlled conditions to suit patients with any anatomical structure.

[0004] Chinese invention patent application CN201911157880.2 discloses an adjustable bend sheath and transjugular intrahepatic puncture system, including a connected tube body and a joint, the tube body radially including an inner tube, a steel tube and an outer tube in sequence from the inside to the outside, the steel tube is provided with a plurality of cutting gaps at intervals along the axial direction, the inner tube is provided with a wire pulling cavity and a delivery cavity, a wire pulling cavity is provided with a wire pulling, and the head end of the wire pulling is fixedly connected to the head end of the steel tube; when the wire pulling is tightened, the wire pulling drives the steel tube to bend, so as to realize the change of the bending shape of the steel tube, and the sheath after the adjustment is matched with the actual vascular distribution of the patient, so as to achieve the purpose of more accurate puncture and delivery of instruments, and improve the safety and effectiveness of the operation. Utility Model Content

[0005] The inventors have found through research that the anatomical path from the inferior vena cava through the right atrium to the coronary sinus is tortuous and complex, and the coronary sinus opening has a large degree of variability, which makes it difficult to enter the coronary sinus with a long fixed-bend sheath or a guide catheter. Existing controllable-bend sheaths are mostly used for surgical operations such as atrial septal puncture and occluder implantation. The head end is relatively hard and the bend is single, which is not suitable for the construction of coronary sinus access.

[0006] The technical problem solved by the utility model is that in coronary sinus surgery, the three-dimensional curved direction of the controllable curved sheath can be highly consistent with the anatomical path of the coronary sinus, so as to realize the rapid construction of the coronary sinus passage.

[0007] To solve the above technical problems, an embodiment of the utility model provides a controllable bending sheath for coronary sinus surgery, comprising: a handle, the handle comprising a control component; a sheath, the sheath comprising at least one hollow cavity, the sheath being connected to the handle at the proximal end, and comprising a transition portion and an end portion at the distal end in sequence, the end portion comprising a bendable component, the movement direction of the bendable component being perpendicular to the extension direction of the sheath body; and at least one bending control wire, one end of the bending control wire being placed in the handle and connected to the control component, and the other end being connected to the bendable component.

[0008] According to some specific embodiments of the present invention, the angle formed by the end portion and the sheath tube body is in the range of 15° to 30°.

[0009] According to certain specific embodiments of the present invention, the transition portion is in an arc shape, and the radius of curvature is in the range of 50.00±5.00 mm.

[0010] According to certain specific embodiments of the present invention, the bendable component includes at least one through hole, and the aperture range of the through hole is 0.90±0.10 mm.

[0011] According to certain specific embodiments of the present invention, the inner diameter of the end portion is in the range of 3.00±0.05 mm, and the outer diameter of the end portion is in the range of 4.00±0.20 mm.

[0012] According to certain specific embodiments of the present invention, the inner diameter range of the bendable component is 2.80±0.05 mm, and the outer diameter range of the bendable component is 3.60±0.05 mm.

[0013] According to certain specific embodiments of the present invention, the bending angle range of the bendable component is -90° to 90°.

[0014] According to certain specific embodiments of the present invention, the length range of the end portion is 70.00±10.00 mm.

[0015] According to some specific embodiments of the present invention, the control component includes a knob mechanism or a pull-out mechanism.

[0016] According to certain specific embodiments of the present invention, the sheath tube includes a polyetheramide resin layer, a stainless steel braided layer, and a polytetrafluoroethylene layer from the outer layer to the inner layer.

[0017] According to certain specific embodiments of the present invention, the sheath tube end comprises a polyetheramide resin layer and a polytetrafluoroethylene layer.

[0018] Compared with the prior art, the technical solution of the embodiment of the utility model has the following beneficial effects:

[0019] First, the transition portion of the sheath is designed to be curved, and a bendable component is provided at the end of the sheath. The movement direction of the bendable component is perpendicular to the extension direction of the sheath. By adopting a three-dimensional controllable curved structure design, the problem of quickly building a pathway from the inferior vena cava through the right atrium to the coronary sinus under different variations in the opening of the coronary sinus is solved.

[0020] Secondly, the end of the sheath is made of a material with lower hardness, which reduces the risk of damaging the inner wall of the blood vessel when the sheath enters the opening of the coronary sinus. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Those skilled in the art should understand that the drawings are intended to schematically illustrate preferred embodiments of the present utility model, and the various components in the drawings are not drawn to scale.

[0022] Figure 1 It is an overall schematic diagram of a controllable bending sheath tube according to certain specific embodiments of the utility model.

[0023] Figure 2 It is a top view of a controllably bendable sheath tube according to certain specific embodiments of the utility model.

[0024] Figure 3 It is a partial enlarged view of the end of the controllable bending sheath tube according to certain specific embodiments of the utility model.

[0025] Main marking instructions

[0026] Steerable bending sheath 1 handle 10 sheath 20

[0027] Handle cover 101 Handle lining 102 Handle core rod 103

[0028] Control component 110 Roller 111 Hemostatic valve 120

[0029] Transition portion 210 End portion 220

[0030] Bendable component 221 Bending control wire 30 DETAILED DESCRIPTION

[0031] Unless otherwise specified, the raw materials used in the examples are all commercially available industrial products and can be purchased through commercial channels.

[0032] Unless otherwise indicated, all numbers used in this specification and claims to represent feature sizes, quantities and physical properties should be understood to be modified by the term "about". Therefore, unless otherwise stated, the numerical parameters listed in this specification and the attached claims are approximate values. According to the teachings of the utility model, a person of ordinary skill in the art can appropriately change these approximate values ​​to obtain the desired characteristics. The numerical range represented by the endpoints includes all values ​​within the range, for example, the radius of curvature ranges 50.00 ± 5.00 mm, including 45.00 mm, 45.01 mm, 45.50 mm, 46.00 mm, 46.80 mm, 48.00 mm, 49.00 mm, 50.00 mm, 54.99 mm, 55.00 mm, etc.

[0033] Unless otherwise specified, the "proximal end" in this specification and claims refers to the end close to the doctor, nurse or other surgical operator during surgery, and the "distal end" refers to the end close to the patient during surgery.

[0034] Existing controllable curved sheaths are mostly used for surgical operations such as atrial septal puncture and occluder implantation. The head end is relatively hard and the curve is single, which is not suitable for the construction of coronary sinus access. In view of the shortcomings of the existing technology, the utility model provides a controllable curved sheath. In the coronary sinus surgery, the three-dimensional curved direction of the controllable curved sheath can be highly consistent with the anatomical path of the coronary sinus, so as to realize the rapid construction of the coronary sinus access.

[0035] In order to make the above-mentioned objects, features and beneficial effects of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0036] like Figure 1 As shown, the controllable bending sheath tube 1 includes a handle 10 and a sheath tube 20 connected to each other. The main body of the sheath tube 10 extends to the distal end, including a transition portion 210 and an end portion 220. The front edge of the end portion 220 includes a bendable component 221. The transition portion 210 is in an arc shape as a whole. In a specific embodiment, the radius of curvature of the transition portion 210 is 50.00 mm, so that the end portion 220 forms an angle α with the main body of the sheath tube 20, and α is 25°. It should be understood by those skilled in the art that the angle α can be adjusted by adjusting the radius of curvature of the transition portion.

[0037] Combination Figure 2The handle 10 includes a handle core rod 103, the proximal end of the sheath tube 10 is nested in the handle core rod 103, the handle outer cover 101 is wrapped around the handle core rod 103, and the handle core liner 102 is filled in the handle outer cover 101 to fix the sheath tube 20 and other components. The handle 10 also includes a control component 110 and a roller 111, and the control component 110 is provided with a knob mechanism. One end of the bending control wire 30 is fixed to the handle 10 through the roller 111, and the other end reaches the sheath tube end 220 along the sheath tube 20 cavity and is fixed on the bendable component 221. When the control component 110 knob is rotated, the wire is linked through the roller 111 to make the bendable component 221 bend to one side, and the bending trajectory is as shown in FIG. Figure 2 As shown by the dotted line, it is perpendicular to the main extension direction of the sheath tube 20, and the bending angle range is -90° to 90°.

[0038] Figure 2 The positions and numbers of the bending control wires 30 are shown by way of example. Those skilled in the art should understand that, in order to achieve the same or similar effects, one bending control wire may be arranged at a symmetrical position, or two symmetrical bending control wires may be arranged.

[0039] Figure 3 for Figure 1 The enlarged view of the middle end HH section, the bendable component 221 includes a through hole, during surgery, the guide catheter or surgical instrument passes through the through hole through the sheath to reach the human tissue, in a specific embodiment, the aperture of the through hole is 0.90mm. The inner diameter of the end is 3.00mm, the outer diameter is 4.00mm, the inner diameter of the bendable component is 2.80mm, the outer diameter is 3.60mm, and the length range of the end is 70.00mm.

[0040] The sheath tube 20 includes a polyetheramide resin layer, a stainless steel braided layer (such as 304 stainless steel), and a polytetrafluoroethylene layer from the outside to the inside. The farthest end of the end 220 can be made of a polyetheramide resin layer and a polytetrafluoroethylene layer. Under the premise of ensuring a certain strength of the sheath tube 20, a soft material is used at the farthest end of the end 220 to prevent scratching of the coronary vein when establishing the passage. The various parts of the sheath tube can be integrally formed, or they can be segmented and connected by physical or chemical means.

[0041] The sheath tube 20 includes at least one hollow cavity, and may also include two or three cavities. During surgery, a guide catheter is placed therein to establish a passage in a vein, and surgical instruments are inserted into the cavity of the guide catheter to perform surgery.

[0042] During coronary sinus surgery, after the controllable bending sheath is pushed to the lower part of the right atrium, the end of the sheath is controlled to be bent by the handle and the bending control wire. The knob of the control component is rotated to drive the bending control wire through the roller. Since the curved design is highly consistent with the path from the opening of the inferior vena cava to the opening of the coronary sinus, the end of the sheath can enter the opening of the coronary sinus by gently rotating the retraction handle, completing the construction of the pathway.

[0043] Compared with the prior art, the technical solution of the embodiment of the utility model has the following beneficial effects:

[0044] First, the transition portion of the sheath is designed to be curved, and a bendable component is provided at the end of the sheath. The movement direction of the bendable component is perpendicular to the extension direction of the sheath. By adopting a three-dimensional controllable curved structure design, the problem of quickly building a pathway from the inferior vena cava through the right atrium to the coronary sinus under different variations in the opening of the coronary sinus is solved.

[0045] Secondly, the end of the sheath is made of a material with lower hardness, which reduces the risk of damaging the inner wall of the blood vessel when the sheath enters the opening of the coronary sinus.

[0046] Although the utility model is disclosed as above, the utility model is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the utility model. Therefore, the protection scope of the utility model shall be subject to the scope defined by the claims.

Claims

1. A controllable bending sheath for coronary sinus surgery, comprising: a handle, the handle comprising a control component; A sheath tube, the sheath tube comprising at least one hollow cavity, the sheath tube being connected to the handle at a proximal end, and comprising a transition portion and an end portion at a distal end in sequence, the end portion comprising a bendable component, and a movement direction of the bendable component being perpendicular to an extension direction of the sheath tube body; and At least one bending control wire, one end of which is placed in the handle and connected to the control component, and the other end of which is connected to the bendable component.

2. The controllable bending sheath tube according to claim 1, characterized in that: The angle formed by the end portion and the sheath tube body is in the range of 15° to 30°.

3. The controllable bending sheath tube according to claim 1, characterized in that: The transition portion is in an arc shape, and the radius of curvature is in the range of 50.00±5.00 mm.

4. The controllable bending sheath tube according to claim 1, characterized in that: The bendable component includes at least one through hole, and the aperture range of the through hole is 0.90±0.10 mm.

5. The controllably bendable sheath tube according to claim 1, characterized in that: The inner diameter of the end portion is in the range of 3.00±0.05 mm, and the outer diameter of the end portion is in the range of 4.00±0.20 mm.

6. The controllably bendable sheath tube according to claim 1, characterized in that: The inner diameter range of the bendable component is 2.80±0.05 mm, and the outer diameter range of the bendable component is 3.60±0.05 mm.

7. The controllably bendable sheath tube according to claim 1, characterized in that: The bending angle range of the bendable component is -90° to 90°.

8. The controllably bendable sheath tube according to claim 1, characterized in that: The length range of the end portion is 70.00±10.00 mm.

9. The controllably bendable sheath tube according to claim 1, characterized in that: The control component includes a knob mechanism or a pull mechanism.

10. The controllably bendable sheath tube according to claim 1, characterized in that: The sheath tube end comprises a polyetheramide resin layer and a polytetrafluoroethylene layer.

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