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CN-122005153-A - Conveying system

CN122005153ACN 122005153 ACN122005153 ACN 122005153ACN-122005153-A

Abstract

The invention provides a delivery system comprising a sheath, a sheath core connector, a rotating ring, and a control wire. The sheath tube comprises a loading section, a sheath core is nested in an inner cavity of the sheath tube, the sheath core comprises a sheath core main body tube, a sheath core connector is sleeved on the sheath core and comprises a near-end fixing part and a far-end rotating part, the fixing part is fixedly arranged on the sheath core main body tube, the rotating part can rotate relative to the sheath core, a rotating ring is sleeved on the fixing part and fixedly connected with the rotating part, and a control wire can drive the sheath tube assembly Duan Zhouxiang to move to adjust the circumferential position of the valve prosthesis. According to the delivery system, the valve prosthesis can be circumferentially adjusted to the optimal position while the whole rotation of the delivery system is avoided, so that the commissure of the valve prosthesis on the Ji Yuansheng aortic valve is ensured after the valve prosthesis is delivered to the designated position, and the release accuracy is improved.

Inventors

  • ZHOU JINGMING
  • PENG FENG

Assignees

  • 深圳市健心医疗科技有限公司

Dates

Publication Date
20260512
Application Date
20241111

Claims (10)

  1. 1. A delivery system, comprising: a sheath for receiving a valve prosthesis, the valve prosthesis having a plurality of prosthesis connectors disposed thereon, the sheath comprising a loading section; The sheath core is arranged in the inner cavity of the sheath tube in a penetrating way and comprises a hollow sheath core main body tube; The sheath core connector is arranged on the sheath core and comprises a fixed part at the proximal end and a rotating part at the distal end, the fixed part is in running fit with the rotating part, the fixed part is fixedly arranged on the distal end side of the sheath core main body tube, the rotating part can rotate relative to the sheath core main body tube, a plurality of rotating part connecting pieces are arranged on the peripheral surface of the rotating part, and the rotating part connecting pieces are detachably connected with the valve prosthesis connecting pieces in a one-to-one correspondence manner; The rotating ring is sleeved on the fixed part and fixedly connected with the proximal end face of the rotating part, the rotating ring can circumferentially rotate relative to the fixed part, and the peripheral surface of the rotating ring is provided with a chute; And a control wire, when the valve prosthesis is at least partially loaded into the sheath, the distal end portion of the control wire is insertable into the chute and moves in the chute along the length of the chute, thereby driving the rotating portion of the sheath-core connector, the valve prosthesis, and the sheath loading Duan Zhouxiang to rotate and thereby adjusting the circumferential position of the valve prosthesis relative to the sheath core.
  2. 2. The delivery system of claim 1, wherein the sheath further comprises a delivery segment, the loading segment being circumferentially rotatable relative to the delivery segment.
  3. 3. The delivery system of claim 1, wherein the sheath core further comprises two reference wires symmetrically distributed along a center of the sheath core body tube.
  4. 4. A delivery system according to claim 3, wherein the proximal side of the fixation section is fixedly connected to the distal sides of the two reference wires.
  5. 5. The delivery system of claim 4, wherein said sheath-core body tube includes two first cavities, one of said reference wires extending through each of said first cavities.
  6. 6. The delivery system of claim 5, wherein two reinforcing wires are further disposed in the sheath and are symmetrical about the center of the sheath, the plane formed by the two reinforcing wires being parallel to the plane formed by the two reference wires.
  7. 7. The delivery system of claim 1, wherein the valve prosthesis comprises leaflets and a valve stent, wherein commissures are provided between the leaflets, and wherein a visualization mark is provided on the valve prosthesis and is provided at a position where the commissures meet at the valve stent.
  8. 8. The delivery system of claim 1, wherein the sheath-core body tube further comprises a third cavity therein, the control wire being nested within the third cavity.
  9. 9. The delivery system of claim 1, wherein the rotational angle of the rotating ring is no less than 30 ° as the distal control wire portion moves in the chute.
  10. 10. The delivery system of claims 1-9, further comprising: a sheath core distal tube nested in the sheath core body tube; The guide head is arranged on the distal end side of the sheath core distal tube.

Description

Conveying system Technical Field The invention belongs to the technical field of medical appliances, and particularly relates to a conveying system. Background This section provides merely background information related to the present disclosure and is not necessarily prior art. Transcatheter aortic valve replacement (TAVR, TRANSCATHETER AORTIC VALVE REPLACEMENT) is a non-open chest surgical procedure for treating severe aortic valve stenosis by delivering a valve prosthesis into the heart through a catheter to replace the diseased aortic valve. TAVR procedures are typically performed through the femoral artery, and the physician makes a small incision in the patient's thigh, and then inserts an elongate catheter through the incision. The catheter is loaded with a valve prosthesis which is released and deployed when the catheter reaches the aortic valve site, secured to the aortic valve annulus, thereby replacing the diseased valve. The aortic valve of the human body consists of three leaflets, behind each of which the aortic wall bulges outwardly, forming the aortic sinus. As shown in fig. 1, two of the three aortic sinuses emit coronary arteries, the left coronary artery 11 and the right coronary artery 12, respectively, the left coronary sinus 13 communicates with the left coronary artery 11, the right coronary sinus 14 communicates with the right coronary artery 12, and is therefore designated as left coronary sinus 13 and right coronary sinus 14, the other coronary artery is the coronary sinus 15, and a commissure 16 exists between the valve leaflets where the respective coronary sinuses are located. The leaflet where the left coronary sinus 13 is located is defined as a first commissure 16a with the leaflet where the right coronary sinus 14 is located, the leaflet where the left coronary sinus 13 is located is commingled with the leaflet where the no coronary sinus 15 is located as a second commissure 16b, and the leaflet where the right coronary sinus 14 is located is commingled with the leaflet where the no coronary sinus 15 is located as a third commissure 16c. Valve prostheses also typically have three leaflets and corresponding commissures, each corresponding to a junction of the aortic valves. As shown in fig. 2, when the commissure 26 of the valve prosthesis 200 is aligned with the commissure 16 of the native aortic valve 100, the left and right coronary sinus 13, 14 are in the stent-hollowed out position of the valve prosthesis 200 with little risk of coronary occlusion. As shown in fig. 3, when the commissure 26 of the valve prosthesis 200 approaches the left coronary sinus 13 and the right coronary sinus 14, the combining portion 23 of the valve prosthesis 200 is located at the same level as the coronary artery opening, and the highest point of the skirt of the valve prosthesis 200 is on the same straight line with the combining portion 23, so that the coronary artery opening is easily blocked, and the risk of coronary artery blockage is high. Ideally, it would be desirable for the commissures of the implanted valve prosthesis to align with the commissures of the native aortic valve, avoiding the valve prosthesis from blocking coronary blood flow. When the commissures of the valve prosthesis are not aligned with the commissures of the native aortic valve, this condition is referred to as commissure misalignment. The commissure dislocation is classified into mild (15.1-30.0 °), moderate (30.1-45 °) and severe (45.1-60.0 °) according to the deviation of the commissure angle with the native aortic valve. I.e. the minimum deflection angle required by the delivery system to achieve commissure alignment is 30 °. If severe commissure misalignment exists, so that the commissure of the valve prosthesis occludes the coronary opening, it may directly cause coronary blockage, which in turn may lead to death of the patient. As TAVR expands towards young, low risk, longer life expectancy patients, lifelong management of cardiovascular disease, including future demands for valve dysfunction and intervention in coronary artery disease, becomes increasingly important. Unlike Surgical Aortic Valve Replacement (SAVR), surgical aotic VALVE REPLACEMENT is capable of actively aligning the commissures of the valve prosthetic leaflets with the commissures of the native Aortic valve and away from the coronary openings under exposed conditions. Current methods for readjusting circumferential position after implantation of a valve in the TAVR field generally require rotation of the entire delivery system, which is prone to failure due to poor circumferential force transduction due to the long path through the aortic arch. Disclosure of Invention Based on this, it is necessary to provide a delivery system that is capable of adjusting the circumferential position of the valve prosthesis relative to the native valve without causing failure of circumferential force conduction due to excessive delivery system path. The pre