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CN-121987390-A - Preassembling system and preassembling method for artificial heart valve

CN121987390ACN 121987390 ACN121987390 ACN 121987390ACN-121987390-A

Abstract

The application relates to a preassembling system and a preassembling method of a prosthetic heart valve, wherein the preassembling system of the prosthetic heart valve comprises the prosthetic heart valve which adopts a deformable structure and has opposite expansion states and compression states, a first conveying device, a second conveying device and a third conveying device, wherein the first conveying device comprises a catheter assembly suitable for interventional conveying and a control handle connected to the proximal end of the catheter assembly, the catheter assembly has opposite distal ends and proximal ends, the prosthetic heart valve is loaded at the distal end part of the catheter assembly in the compression state, and the second conveying device comprises a sheath tube which is sleeved on the periphery of the catheter assembly in a sliding mode and a connecting seat which is fixed to the proximal end of the sheath tube, and the sheath tube wraps the prosthetic heart valve and keeps the prosthetic heart valve in the compression state. The application can simplify the field operation flow of doctors or auxiliary personnel during operation, reduce the error risk and improve the operation efficiency.

Inventors

  • ZENG MIN
  • FAN ZHENG

Assignees

  • 杭州汇诺心生物技术有限公司

Dates

Publication Date
20260508
Application Date
20260402
Priority Date
20250617

Claims (11)

  1. 1.A preassembly system for a prosthetic heart valve, comprising: a prosthetic heart valve employing a deformable structure and having opposed expanded and compressed states; A first delivery device comprising a catheter assembly adapted for interventional delivery, the catheter assembly having opposite distal and proximal ends, and a control handle connected to the proximal end of the catheter assembly, the prosthetic heart valve being mounted in a compressed state at a distal site of the catheter assembly; The second conveying device comprises a sheath tube which is sleeved on the periphery of the catheter assembly in a sliding manner and a connecting seat which is fixed at the proximal end of the sheath tube, and the sheath tube wraps the artificial heart valve and keeps the artificial heart valve in a compressed state; the second conveying device is opposite to the first conveying device: A combined state in which the catheter assembly penetrates the second delivery device, the distal end of the catheter assembly having a guide head, the guide head being located on the distal side of the sheath in the combined state; a detached state, relative to an engaged state, wherein the catheter assembly is moved proximally and out of the second delivery device; Wherein the guide head is a deformable structure having opposite: a preset shape for the distal end of the sheath to abut and axially block the sheath; A collapsed shape radially collapsed relative to a predetermined shape and capable of accessing the sheath to permit the second delivery device to move toward a detached state.
  2. 2. The prosthetic heart valve preassembly system of claim 1 wherein the sheath is 60cm to 120cm in length and in combination comprises, relative to the prosthetic heart valve: A loading position, wherein the sheath encloses the prosthetic heart valve; A release position, the sheath being further proximally offset relative to the loading position and exposing the prosthetic heart valve.
  3. 3. The preassembly system of prosthetic heart valve of claim 2 wherein the distal end portion of the sheath has a structural reinforcement section, the sheath wrapping the prosthetic heart valve through the structural reinforcement section in the stowed position; the distal end of the sheath is provided with a deformable expansion structure, the expansion structure comprises a plurality of elastic sheets which are circumferentially arranged, and the distal sides of the elastic sheets can be turned outwards or gathered together relatively.
  4. 4. The prosthetic heart valve preassembly system of claim 1 wherein the guide head is of an elastically deformable material that switches between a pre-set shape and a collapsed shape by elastic deformation.
  5. 5. The prosthetic heart valve preassembly system of claim 1 wherein the guide head has a core bore therein for extending the guide wire, the core bore having a reduced cross-section in the collapsed shape relative to the preset state, at least a portion of the core bore being an expanded diameter region to absorb deformation of the guide head.
  6. 6. The preassembly system of claim 1 wherein the guide head has a stop step on its periphery, the guide head being configured to block relative distal movement of the sheath in a predetermined shape by the stop step, the stop step having a tapered surface and converging proximally.
  7. 7. The preassembly system of claim 1 wherein the guide head has a deformation relief groove on its outer periphery, the deformation relief groove extending axially and/or circumferentially.
  8. 8. The prosthetic heart valve preassembly system of claim 1 wherein the guide head is integrally formed from a radially deformable metal mesh cage structure formed from wire braiding or metal tubing cutting.
  9. 9. The prosthetic heart valve preassembly system of claim 1 wherein the catheter assembly includes: The guide head is fixed at the far end of the core tube; the balloon body is arranged on the periphery of the core tube, the far end of the balloon body is connected with the core tube in a sealing way, the artificial heart valve is sleeved on the periphery of the balloon body, and an axial limiting piece connected with the core tube is further arranged in the balloon body; and the extension pipe is arranged on the periphery of the core pipe and is butted with the proximal end of the balloon body, and a fluid channel is arranged between the extension pipe and the core pipe and is used for conveying fluid into the balloon body.
  10. 10. The prosthetic heart valve preassembly system of claim 1 wherein the catheter assembly includes: The guide head is fixed at the far end of the core tube; the balloon body is arranged on the periphery of the core tube, and the distal end of the balloon body is connected with the core tube in a sealing way; The artificial heart valve is sleeved on the periphery of the extension tube and is positioned at the proximal end side of the balloon body, and a fluid channel is arranged between the extension tube and the core tube and used for conveying fluid into the balloon body; the pushing pipe is sleeved on the periphery of the extension pipe in a sliding manner and is positioned at the proximal end side of the artificial heart valve and used for pushing the artificial heart valve to the periphery of the saccule body.
  11. 11. A method of preassembling a prosthetic heart valve, based on the preassembly system of any of claims 1-10, the method comprising: Providing a prosthetic heart valve in a deformable configuration and having opposed expanded and compressed states, and a first delivery device with a catheter assembly; sleeving the prosthetic heart valve in a compressed state to the catheter assembly; providing a second delivery device with a sheath, encasing the sheath in the catheter assembly and surrounding the prosthetic heart valve.

Description

Preassembling system and preassembling method for artificial heart valve Technical Field The application relates to the technical field of medical appliances, in particular to a preassembling system and a preassembling method of a prosthetic heart valve. Background Cardiovascular interventional therapy technology continues to develop, particularly Transcatheter Aortic Valve Replacement (TAVR) related technologies are of great interest. During heart valve replacement surgery operations, a physician or auxiliary personnel is required to position and install the prosthetic valve at the surgical site. In current procedures, prosthetic valves are loaded into the catheter assembly. Valve sizing, pretreatment, and loading into a catheter assembly are often performed intraoperatively due to lack of pre-planning and pre-loading mechanisms. Each link in the loading process may have connection deviation or excessively long time due to subjective judgment and operation proficiency, which requires medical staff to be specially trained, resulting in excessively high learning cost. More cases are that the professional technicians of the producer guide or operate on the operation site, which not only increases the cost, but also greatly limits the wide application of the product. Disclosure of Invention The application provides a preassembling system of a prosthetic heart valve, which can further improve the operation convenience. The application relates to a preassembly system of a prosthetic heart valve, which comprises: a prosthetic heart valve employing a deformable structure and having opposed expanded and compressed states; A first delivery device comprising a catheter assembly adapted for interventional delivery, the catheter assembly having opposite distal and proximal ends, and a control handle connected to the proximal end of the catheter assembly, the prosthetic heart valve being mounted in a compressed state at a distal site of the catheter assembly; The second conveying device comprises a sheath tube and a connecting seat, the sheath tube is sleeved on the periphery of the catheter assembly in a sliding mode, the connecting seat is fixed at the proximal end of the sheath tube, and the sheath tube wraps the artificial heart valve and keeps the artificial heart valve in a compressed state. The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions. Optionally, the second conveying device and the first conveying device have opposite directions: A combined state, wherein the catheter assembly penetrates the second delivery device; The catheter assembly is moved proximally and out of the second delivery device relative to the engaged state. Optionally, the sheath tube has a length of 60cm to 120cm, and in the combined state, the sheath tube has relative to the prosthetic heart valve: A loading position, wherein the sheath encloses the prosthetic heart valve; A release position, the sheath being further proximally offset relative to the loading position and exposing the prosthetic heart valve. Optionally, the distal end of the catheter assembly has a guide head, the guide head being located on the distal side of the sheath in the coupled state, the guide head being of a deformable structure having opposite: a preset shape for the distal end of the sheath to abut and axially block the sheath; A collapsed shape radially collapsed relative to a predetermined shape and capable of accessing the sheath to permit the second delivery device to move toward a detached state. Optionally, the guide head is made of elastic deformation material, and is switched to a preset shape and a furled shape through elastic deformation. The guide head has a core hole inside for the guide wire to extend, and the cross section of the core hole is reduced in the folded shape relative to the preset state. At least a portion of the core hole is a diameter-enlarging region to absorb deformation of the guide head. Optionally, the periphery of the guiding head is provided with a limiting step, and the guiding head can stop the sheath tube from moving towards the distal end relatively under the preset shape through the limiting step. Optionally, a deformation absorbing region is arranged in the guide head, and when the guide head deforms, the limiting step radially collapses towards the deformation absorbing region so as to avoid relative movement of the sheath tube towards the far end. Optionally, the step surface of the limiting step is a conical surface and gradually converges towards the proximal end side. Optionally, a deformation release groove is formed in the periphery of the guide head. Optionally, the deformation release groove extends axially and/or circumferentially