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CN-122005152-A - Conveying system

CN122005152ACN 122005152 ACN122005152 ACN 122005152ACN-122005152-A

Abstract

The invention provides a delivery system comprising a sheath, a sheath core, and a sheath core connector. The sheath core is nested in the inner cavity of the sheath tube, the sheath core comprises a sheath core main body tube and two reference wires which are symmetrical along the center of the sheath core, the 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, and the rotating part can rotate relative to the sheath core. According to the delivery system of the invention, the rotating part of the sheath core connector can be rotated to circumferentially adjust the valve prosthesis to the optimal orientation before the valve prosthesis is loaded into the sheath, so that the commissure of the valve prosthesis to 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 being provided with a plurality of prosthesis connectors; The sheath core is arranged in the inner cavity of the sheath tube in a penetrating mode and comprises a hollow sheath core main body tube and two reference wires symmetrically distributed in the sheath core main body tube along the center of the sheath core main body tube; The sheath core connector is arranged on the sheath core and comprises a fixing part at the proximal end and a rotating part at the distal end, the fixing part is in running fit with the rotating part, the fixing 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 are detachably connected with the valve prosthesis connecting pieces in one-to-one correspondence, and after the valve prosthesis is connected with the rotating part and before the valve prosthesis is not fully loaded into the sheath tube, the rotating part can rotate circumferentially relative to the fixing part so as to drive the valve prosthesis to rotate circumferentially to a preset position.
  2. 2. The delivery system of claim 1, wherein a proximal side of the fixation portion is fixedly coupled to a distal side of the two reference wires.
  3. 3. The delivery system of claim 1, wherein said sheath-core body tube includes two first cavities, one of said reference wires extending through each of said first cavities.
  4. 4. The delivery system of claim 1, 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.
  5. 5. 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.
  6. 6. The delivery system of claim 1, wherein the fixed portion and the rotating portion are rotationally engaged in a stepped bore engagement or a ball lock shaft engagement.
  7. 7. The conveyor system as in claim 6 wherein the step Kong Chencao table is provided with a resilient member.
  8. 8. The delivery system of claim 1, further comprising a retaining wire, wherein the proximal side of the sheath-core connector rotating portion is provided with one or more receiving members, wherein the distal end of the retaining wire is receivable in the receiving members, and wherein the sheath-core connector is circumferentially locked when the retaining wire is received in the receiving members.
  9. 9. The delivery system of claim 8, wherein the sheath core further comprises one or more second cavities, the stopper wire being threaded into the second cavities, the stopper wire being axially movable in the second cavities relative to the sheath core.
  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 Aortic VALVE REPLACEMENT) which 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, there is currently no available device or method in the TAVR field to achieve commissure alignment, limiting the use of TAVR. Disclosure of Invention Based on this, it is necessary to provide a delivery system that enables adjustment of the circumferential position of the valve prosthesis relative to the native valve to achieve alignment of the commissures of the valve prosthesis with the commissures of the native valve. The present invention provides a conveying system comprising: the sheath tube is used for accommodating the valve prosthesis, and a plurality of prosth