Catheter assembly, implant system, implant delivery system and methods of use thereof

Abstract

The present application provides a kind of catheter assembly, implant system, implant delivery system and its use method, implant delivery system is by the material of the inner tube, the material of the outer sheath tube and the guide wire tube are all plastic material, the distal end of the outer sheath tube and the guide wire tube are all shaped as curved, and provide curved passage to the inner tube, the inner tube is elastically arranged in the curved passage, so that outer sheath tube control device and inner tube control device are all without the design requirement of controlled bending, reduce the design requirement and design difficulty of outer sheath tube control device and inner tube control device, thereby reduce the cost, also make the operation of implant delivery system more simple, more safe and reliable, reduce the requirement of surgical incision, and can realize curved delivery, can accurately deliver stent to specified position.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a catheter assembly, an implant system, an implant delivery system, and a method of using the same. Background Technology

[0002] Heart valves are membranous structures in the organs of humans and some animals that can open and close. Each person's heart has four valves: the aortic valve, which connects the left ventricle and the aorta; the pulmonary valve, which connects the right ventricle and the pulmonary artery; the mitral valve, which connects the left atrium and the left ventricle; and the tricuspid valve, which connects the right atrium and the right ventricle. They all act as one-way valves, ensuring that blood flows only in one direction and not backwards.

[0003] With socioeconomic development and population aging, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in people over 75 years of age is as high as 13.3%. Currently, traditional surgical treatment is still the first choice for patients with severe valvular disease. However, for elderly patients, those with multiple organ diseases, those with a history of open-heart surgery, and those with poor cardiac function, traditional surgery carries high risks and mortality rates, and some patients may not even have the opportunity to undergo surgery.

[0004] Interventional valve implantation is a novel minimally invasive valve replacement technique developed internationally in recent years. Its principle involves loading a valve prosthesis into a delivery system and delivering it into the body via a catheter to replace the degenerated original valve, thereby improving the patient's heart function. This technique allows for the treatment of valvular disease without open-heart surgery or stopping the heart, eliminating the significant trauma caused to patients by traditional open-heart surgery and cardiac arrest.

[0005] The human heart has a highly complex structure, especially the tricuspid valve. Its annulus is irregularly shaped, and the ventricles contain multiple chordae tendineae and septal muscular columns. This complex structure interferes with the implantation of interventional valves. In open-heart tricuspid valve replacement via the atrial appendage, traditional straight-tube delivery systems struggle to deliver the artificial valve to the precise location. This necessitates an incision directly opposite the tricuspid valve annulus, often located off-center from the patient's back, demanding exceptional skill from the surgeon. The incision is frequently significantly offset from the annulus, making accurate placement difficult and hindering the release of the artificial valve at optimal position and angle. This can lead to operator error, inaccurate stent placement, and in severe cases, serious paravalvular leakage / regurgitation.

[0006] In addition, traditional controllable bending delivery systems require a handle-controlled bending device to control the pull wire and pull wire ring to achieve catheter bending and implant installation and release in order to meet the needs of implant installation and release and catheter bending. However, the design of the handle-controlled bending device increases the design and material costs and design difficulty; the pull wire design for catheter bending may have insufficient pull wire strength, and there is a risk of breakage of the pull wire, handle, pull wire and pull wire ring. Summary of the Invention

[0007] The purpose of this invention is to provide a catheter assembly, an implant system, an implant delivery system, and a method of using the same, which can solve the problems of traditional delivery systems, such as difficulty in delivery, inaccurate release, extremely high requirements for incision location, complex structure, high operational difficulty, and low safety.

[0008] To address the aforementioned problems, the present invention provides a catheter assembly comprising an outer sheath, an inner tube, and a guidewire, which are sequentially sleeved from the outside in. The inner tube is made of an elastic material, while the outer sheath and guidewire are both made of malleable materials. The distal ends of the outer sheath and guidewire are both shaped into a curved shape and provide a curved channel to the inner tube, which is elastically inserted into the curved channel.

[0009] Optionally, the outer sheath is made of a polymer material, and the Shore D hardness of the polymer material is 70HD to 90HD; or,

[0010] The outer sheath is made of a metal material with a Rockwell hardness of 20HRC to 50HRC.

[0011] Optionally, the guidewire is made of a polymer material, and the Shore D hardness of the polymer material is 70HD to 90HD; or,

[0012] The guide wire is made of metal, and the Rockwell hardness of the metal is 20HRC to 50HRC.

[0013] Furthermore, the polymer material includes PA, PI, or PEEK; the metal material includes 304 stainless steel or 316 stainless steel.

[0014] Optionally, the inner tube is made of Pebax, TPU, LDPE, NR, or NBR, and the Shore D hardness of the inner tube is 40HD to 70HD.

[0015] Optionally, the outer sheath includes a first straight pipe section and a first bent pipe section arranged axially, the first straight pipe section being disposed at the proximal end of the outer sheath, the first bent pipe section being disposed at the distal end of the outer sheath, and the distal end of the first straight pipe section being detachably connected to the proximal end of the first bent pipe section.

[0016] Optionally, the guide wire tube includes a second straight section, a second bent section, and a third straight section arranged sequentially along the axial direction. The second straight section is located at the proximal end of the guide wire tube, and the third straight section is located at the distal end of the guide wire tube. The distal end of the second straight section is detachably connected to the proximal end of the second bent section, and the first bent section has a bending angle.

[0017] Furthermore, the first straight pipe segment is fitted outside the second straight pipe segment, the first bent pipe segment is fitted outside the second bent pipe segment, the second bent pipe segment has a bending angle, and the bending angle of the first bent pipe segment and the bending angle of the second bent pipe segment are the same.

[0018] On the other hand, the present invention also provides an implant delivery system, including a catheter assembly and a delivery handle, the delivery handle being disposed at the proximal end of the catheter assembly, the delivery handle including an outer sheath control device, an inner tube control device and a guidewire fixation device, the outer sheath control device being connected to the proximal end of the outer sheath and used to control the axial movement of the outer sheath; the inner tube control device being connected to the proximal end of the inner tube and used to control the axial movement of the inner tube; and the guidewire fixation device being connected to the proximal end of the guidewire.

[0019] In another aspect, the present invention also provides an implant system including the catheter assembly, a delivery handle, a conical head, and a fixation head, wherein the fixation head and the conical head are sequentially disposed from the proximal end to the distal end of the inner tube, the implant is held within the inner tube, and at least a majority of the implant is confined between the conical head and the fixation head.

[0020] In another aspect, the present invention also provides a method of using an implant delivery system, comprising the aforementioned implant delivery system, the method of using the system comprising:

[0021] The first and second bends are selected based on the patient's heart structure, wherein the bending angle of the first bend is the same as that of the second bend.

[0022] The proximal end of the first bend section is detachably installed at the distal end of the first straight section, and the proximal end of the second bend section is detachably installed at the distal end of the second straight section; and

[0023] The inner tube is flexibly inserted into the curved channel provided by the first and second bends.

[0024] Compared with the prior art, the present invention provides a catheter assembly, an implant system, an implant delivery system, and a method of using the same. In the catheter assembly, the inner tube is made of an elastic material, while the outer sheath and guidewire are made of malleable materials. The distal ends of the outer sheath and guidewire are both shaped into a curved shape, providing a curved channel to the inner tube. The inner tube is elastically inserted into the curved channel, eliminating the need for bending control design in both the outer sheath control device and the inner tube control device. This reduces the design requirements and difficulty of the outer sheath control device and the inner tube control device, thereby reducing costs. It also makes the operation of the implant delivery system simpler, safer, and more reliable, reduces the requirements for surgical incisions, and enables curved delivery, allowing the stent to be accurately delivered to the designated location.

[0025] In addition, the present invention allows the distal end of the first straight tube segment to be detachably connected to the proximal end of the first curved tube segment, and the distal end of the second straight tube segment to be detachably connected to the proximal end of the second curved tube segment. This enables the implant delivery system to be designed only for the first and second curved tube segments when different bending angles are required, thereby reducing costs and improving the compatibility of the straight tube segments of the catheter assembly. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of an implant delivery system according to an embodiment of the present invention;

[0027] Figures 2a-2b for Figure 1 Enlarged view of region A in the middle;

[0028] Figures 3a-3c This is a connection method between the first bend and the first straight pipe section according to an embodiment of the present invention;

[0029] Figures 4a-4e This is a schematic diagram of the structure of the outer sheath tube according to an embodiment of the present invention;

[0030] Figures 5a-5b This is a schematic diagram of the guide wire tube according to an embodiment of the present invention;

[0031] Figure 6 This is a schematic diagram of the implant delivery system in the heart according to an embodiment of the present invention.

[0032] Explanation of reference numerals in the attached figures:

[0033] 1-Catheter assembly; 110-Outer sheath; 111-First straight tube segment; 112-First curved tube segment; 113-Intermediate connecting core; 120-Inner tube; 121-First sub-inner tube; 122-Second sub-inner tube; 130-Guidewire; 131-Second straight tube segment; 132-Second curved tube segment; 133-Third straight tube segment; 140-Conical head; 150-Fixing head;

[0034] 2-Conveyor handle; 21-Outer sheath control device; 22-Inner tube control device; 23-Guide wire fixing device;

[0035] 3-Implants. Detailed Implementation

[0036] The following will provide a more detailed description of a catheter assembly, implant system, implant delivery system, and method of use of the present invention. The invention will now be described in more detail with reference to the accompanying drawings, which illustrate preferred embodiments of the invention. It should be understood that those skilled in the art can modify the invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the invention.

[0037] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not detailed in detail, as they would obscure the invention with unnecessary detail. It should be understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's specific objectives, such as changes from one embodiment to another according to limitations related to the system or business. Furthermore, it should be understood that such development work may be complex and time-consuming, but is merely routine work for those skilled in the art.

[0038] To make the objectives and features of the present invention more apparent and understandable, the specific embodiments of the present invention will be further described below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise ratios, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. In this document, the term "or" is generally used to include the meaning of "and / or" unless otherwise expressly stated. The terms "inner," "outer," and similar expressions used herein are for illustrative purposes only and do not represent the only possible embodiments. In this document, the terms "distal" and "proximal" refer to the relative orientation, position, or direction of elements or actions relative to each other from the perspective of a physician using the medical device. Although "distal" and "proximal" are not restrictive, "proximal" generally refers to the end of the medical device closer to the operator during normal operation, and "distal" generally refers to the end closer to the patient's heart.

[0039] The core idea of ​​this invention is to provide a catheter assembly, comprising an outer sheath, an inner tube, and a guidewire that are sequentially sleeved from the outside to the inside. The inner tube is made of an elastic material, while the outer sheath and guidewire are both made of malleable materials. The distal ends of the outer sheath and guidewire are both shaped into a curved shape and provide a curved channel to the inner tube, which is elastically inserted into the curved channel.

[0040] An implant delivery system includes a catheter assembly and a delivery handle. The delivery handle is disposed at the proximal end of the catheter assembly. The delivery handle includes an external sheath control device, an internal tube control device, and a guidewire fixation device. The external sheath control device is connected to the proximal end of the external sheath and is used to control the axial movement of the external sheath. The internal tube control device is connected to the proximal end of the internal tube and is used to control the axial movement of the internal tube. The guidewire fixation device is connected to the proximal end of the guidewire.

[0041] An implant system includes a catheter assembly, a delivery handle, a conical head, and a fixation head, the fixation head and the conical head being sequentially disposed from proximal to distal end of an inner tube, an implant being held within the inner tube, and at least a majority of the implant being confined between the conical head and the fixation head.

[0042] A method of using an implant delivery system, comprising the implant delivery system, the method of using the system comprising:

[0043] The first and second bends are selected based on the patient's heart structure, wherein the bending angle of the first bend is the same as that of the second bend.

[0044] The proximal end of the first bend section is detachably installed at the distal end of the first straight section, and the proximal end of the second bend section is detachably installed at the distal end of the second straight section; and

[0045] The inner tube is flexibly inserted into the curved channel provided by the first and second bends.

[0046] like Figure 1 As shown, this embodiment provides an implant delivery system, which includes a catheter assembly 1 and a delivery handle 2 arranged sequentially from the distal end to the proximal end.

[0047] like Figures 2a-2b As shown, the catheter assembly 1 includes an outer sheath 110, an inner tube 120, and a guidewire tube 130, which are sequentially connected from the outside to the inside. That is, the outer sheath 110 is sleeved on the outside of the inner tube 120, the inner tube 120 is sleeved on the outside of the guidewire tube 130, and a guidewire is provided inside the guidewire tube 130.

[0048] The inner tube 120 is made of a soft material, meaning that all the sub-inner tubes are made of a soft material. The soft material can be a soft polymer material, such as Pebax, TPU, LDPE, NR, NBR, etc., and the Shore D hardness of the soft material is 40HD to 70HD.

[0049] The inner tube 120 includes at least one sub-inner tube, such as one, two, or more sub-inner tubes, that is, the inner tube 120 includes at least a first sub-inner tube 121. All the sub-inner tubes are sequentially sleeved from the inside to the outside, and the first sub-inner tube 121 is located at the outermost layer of the inner tube.

[0050] The delivery handle 2 includes an outer sheath control device 21, an inner tube control device 22, and a guide wire fixing device 23. The outer sheath control device 21 is connected to the proximal end of the outer sheath 110 and is used to control the axial movement of the outer sheath 110. The inner tube control device 22 is connected to the proximal end of the inner tube 120 and is used to control the axial movement of the inner tube 120. Specifically, the inner tube control device 22 includes at least one sub-inner tube control device, and the number of sub-inner tube control devices is the same as the number of sub-inner tubes. Each sub-inner tube control device is connected to the proximal end of one sub-inner tube and is used to control the axial movement of one sub-inner tube. The guide wire fixing device 23 is connected to and fixes the proximal end of the guide wire 130.

[0051] The outer sheath 110 is made of a hard material, which can be a polymer material or a metal material. The polymer material can be, for example, a polymer material such as PA / PI / PEEK, and the Shore D hardness of the polymer material is 70HD to 90HD. The metal material can be 304 stainless steel, 316 stainless steel, etc., and the Rockwell hardness of the metal material is 20HRC to 50HRC.

[0052] For implant delivery systems that require travel through curved approaches, the bending angle A and bending radius R are typically used to characterize the bending requirements during the implant delivery process. For example, the approach for an artificial valve is often not a straight line, requiring a certain angle, which we call the bending angle. Since the artificial valve approach needs to be completed within the heart, the space between the atria and ventricles requires different control radii for the implant delivery system; this control radius is called the bending radius. To meet the bending requirements during the implant delivery process, the outer sheath 110 includes a first straight section 111 and a first curved section 112 connected axially, with the first straight section 111 located at the proximal end of the outer sheath 110 and the first curved section located at the distal end of the outer sheath 110. The axis of the first straight pipe section 111 is a straight line, and the axis of the first bent pipe section 112 is an arc, specifically, for example, a circular arc. The outer sheath 110, through the curved shape of the first bent pipe section 112 with an arc axis and the non-deformable material of the outer sheath 110, makes the outer sheath control device 21 have no need for bending control design when the outer sheath 110 travels in an access road with a bending angle. This reduces the design requirements and design difficulty of the outer sheath control device 21, thereby reducing costs.

[0053] Based on the required bending radius of the implant delivery system, the first bend section 112 can be designed with different bending radii R1, and different bending angles A can be designed according to the access path of the implant delivery system. Specifically, under the condition that the bending radius R1 is constant, different bending angles A1 can be adjusted, and the bending angle A1 is greater than 0°, such as 30°, 45°, etc. Figure 4a (as shown), 60°, 90° (as shown) Figure 4b (as shown), 120°, 135° (as shown) Figure 4c (as shown), 180° (as shown) Figure 4d (As shown), commonly used angles such as 270° and 360°, and of course, any angle greater than 0 such as 10°, 15°, 20°, 50°, and 144°. Figure 4e As shown, under the condition that the bending angle A1 is constant, the bending radius R1 of different lengths is adjusted.

[0054] The proximal end of the first curved tube segment 112 is detachably connected to the distal end of the first straight tube segment 111, allowing the implant delivery system to be designed with only the first curved tube segment to meet different bending angle requirements. Specifically, as shown... Figure 3a As shown, the proximal end of the first bent pipe section 112 and the distal end of the first straight pipe section 111 are bonded together by adhesive located outside the outer sheath 110; as Figure 3b As shown, the proximal end of the first bend section 112 has an external thread, and the distal end of the first straight section 111 has an internal thread that matches the external thread. The proximal end of the first bend section 112 is threadedly connected to the distal end of the first straight section 111. Alternatively, the proximal end of the first bend section 112 has an internal thread, and the distal end of the first straight section 111 has an external thread that matches the internal thread. The proximal end of the first bend section 112 is threadedly connected to the distal end of the first straight section 111. Figure 3c As shown, the outer sheath 110 further includes an intermediate connecting core 113. The intermediate connecting core 113 is tubular, with an inner diameter the same as that of the outer sheath 110. Both ends of the intermediate connecting core 113 have external threads. The proximal end of the first bent pipe section 112 and the distal end of the first straight pipe section 111 both have internal threads that match the external threads. The proximal end of the first bent pipe section 112 and the distal end of the first straight pipe section 111 are threadedly connected to both ends of the intermediate connecting core 113. Alternatively, the inner diameter of the intermediate connecting core 113 is the same as that of the outer sheath 110, and both ends of the intermediate connecting core 113 have internal threads. The proximal end of the first bent pipe section 112 and the distal end of the first straight pipe section 111 both have external threads that match the internal threads. The proximal end of the first bent pipe section 112 and the distal end of the first straight pipe section 111 are threadedly connected to both ends of the intermediate connecting core 113.

[0055] In another embodiment, the outer sheath 110 further includes a distal straight pipe section, the axis of which is a straight line, and the proximal end of the distal straight pipe section is connected to the distal end of the first curved pipe section 112.

[0056] The guide wire tube 130 is made of a rigid material, which can be a polymer material or a metal material. The polymer material can be, for example, a polymer material such as PA / PI / PEEK, and the Shore D hardness of the polymer material is 70HD to 90HD. The metal material can be 304 stainless steel, 316 stainless steel, etc., and the Rockwell hardness of the metal material is 20HRC to 50HRC.

[0057] like Figures 5a-5bAs shown, the guidewire tube 130 includes a second straight tube section 131, a second bent tube section 132, and a third straight tube section 133 connected sequentially along the axial direction. The second straight tube section 131 is located at the proximal end of the guidewire tube 130, and the third straight tube section 133 is located at the distal end of the guidewire tube 130. The first straight tube section 111 is sleeved on the outside of the second straight tube section 131; the third straight tube section 133 extends beyond the distal end of the outer sheath tube 110, that is, the third straight tube section 133 extends beyond the distal end of the first bent tube section 112; the first bent tube section 112 is sleeved on the outside of the second bent tube section 132. The axes of the second straight pipe section 131 and the third straight pipe section 133 are both straight lines, while the axis of the second bent pipe section 132 is an arc, specifically a circular arc. The bending angle A2 of the second bent pipe section 132 is the same as the bending angle A1 of the first bent pipe section 112, so that the first bent pipe section 112 and the second bent pipe section 132 are arranged in parallel, thereby allowing the inner pipe 120 to pass smoothly between the first bent pipe section 112 and the second bent pipe section 132. The guidewire 130 and the outer sheath 110 are constructed together along the axial direction in a curved shape (i.e., the curved shape of the first and second curved sections). Since the outer sheath 110 and the guidewire 130 have the same bending angle, and the rigid materials of the outer sheath 110 and the guidewire 130 are non-deformable, they can provide a curved channel. The soft material of the inner tube 120 located between the outer sheath 110 and the guidewire 130 has a certain deformation capacity, allowing the inner tube to bend. This ensures that the inner tube 120 can smoothly pass through the curved channel constructed by the first and second curved sections. At the same time, the inner tube 120 has a certain rigidity to ensure the wrapping force on the compressed implant, thereby realizing the loading and release of the implant. Meanwhile, the outer sheath 110 and the guidewire 130 provide a bending channel, allowing the soft inner tube 120 to bend and travel in the access without the need for a bending control design. This reduces the design requirements and difficulty of the inner tube control device 22, thereby reducing costs. It also makes the operation of the implant delivery system simpler, safer, and more reliable, reduces the requirements for surgical incisions, and enables bending delivery, allowing the stent to be accurately delivered to the designated position.

[0058] The proximal end of the second bend section 132 is detachably connected to the distal end of the second straight section 131, specifically by adhesive bonding (e.g., ...). Figure 3a Connection method), direct threaded connection (such as...) Figure 3b Connection method) or intermediate connecting core 113 threaded connection (such as Figure 3b The second bend section 132 and the third straight section 133 can be integrally formed or detachably connected (specifically, as shown in the connection method). Figures 3a-3c (Connection method shown).

[0059] Please see Figure 1 This embodiment also provides an implant system, which includes a catheter assembly and a delivery handle. The distal end of the catheter assembly 1 further includes a conical head 140 and a fixation head 150. The fixation head 150 is disposed within the distal end of the first sub-inner tube 121, restricting all six degrees of freedom of the fixation head 150 and used to fix the implant 3. The conical head 140 is detachably disposed at the distal end of the first sub-inner tube 121, and the implant 3 is positioned proximally to the fixation head 150. The implant 3 is, for example, a valve stent. The number of sub-inner tubes of the inner tube varies depending on the specific needs of the implant 3.

[0060] like Figure 2a As shown, the implant 3 includes only the main body, the inner tube 120 includes only the first sub-inner tube 121, the conical head 140 is disposed in the distal end of the first sub-inner tube 121, and the implant 3 is positioned between the fixing head 150 and the conical head 140.

[0061] like Figure 2b As shown, the implant 3 includes a main body portion located at the distal end and a flange portion located at the proximal end. The inner tube 120 includes a first sub-inner tube 121 and a second sub-inner tube 122. The first sub-inner tube 121 is sleeved on the outside of the second sub-inner tube 122, and the distal end of the first sub-inner tube 121 extends beyond the distal end of the second sub-inner tube 122. The distal end of the second sub-inner tube 122 is connected to the fixing head 150. The main body portion is limited between the fixing head 150 and the conical head 140. The flange portion is fixed to the distal end of the second sub-inner tube 122.

[0062] The method of using the implant delivery system in this embodiment is as follows:

[0063] Taking the inner tube as an example, which only includes the first sub-inner tube 121, firstly, the patient's heart structure is initially assessed using ultrasound or other methods before surgery to obtain the required bending angle. Based on the bending angle, a first bend segment 112 and a second bend segment 132 with the same or similar commonly used bending angles (e.g., 30°, 45°, 60°, 90°, etc.) are directly selected (of course, they can also be customized according to the bending angle). The first bend segment 112 is installed at the distal end of the first straight tube segment 111, and the second bend segment 132 is installed at the distal end of the first straight tube segment 111. Installed at the distal end of the second straight tube section 131, the third straight tube section 133 is located at the distal end of the second curved tube section 132, and the first sub-inner tube 121 is inserted between the outer sheath tube 110 and the guide wire tube 130; then, the sub-inner tube control device controlling the first sub-inner tube 121 is operated to install the implant to the distal end of the implant delivery system, that is, to press it into the distal end of the first sub-inner tube and limit it between the fixing head 150 and the conical head 140, so as to complete the installation of the implant in the implant delivery system; then, as Figure 6 As shown, the curved implant delivery system is delivered to the designated location in the heart, and the implant is safely released by operating the first sub-inner tube control device.

[0064] Taking the inner tube 120 as an example, which only includes the first sub-inner tube 121 and the second sub-inner tube 122, firstly, the patient's cardiac structure is initially assessed using ultrasound or other methods before the operation to obtain the required bending angle. Based on the bending angle, the first bending tube segment 112 and the second bending tube segment 132 with the same or similar commonly used bending angles (e.g., 30°, 45°, 60°, 90°, etc.) are directly selected. The first bending tube segment 112 is installed at the distal end of the first straight tube segment 111, and the second bending tube segment 132 is installed at the distal end of the second straight tube segment 131. The first sub-inner tube 121 and the second sub-inner tube 122 are then inserted into the outer sheath tube 11. Between 0 and guide wire 130, wherein the first sub-inner tube 121 is sleeved outside the second sub-inner tube 122; then, the first sub-inner tube 121 control device controlling the first sub-inner tube 121 and the second sub-inner tube 122 control device controlling the second sub-inner tube 122 are operated to install the implant to the distal end of the implant delivery system, the main body of the implant is pressed into the distal end of the second sub-inner tube 122 and is limited between the fixing head 150 and the conical head 140, and the flange of the implant is fixed to the distal end of the first sub-inner tube 121 to complete the installation of the implant in the implant delivery system; then, as Figure 6 As shown, the curved implant delivery system is delivered to a designated location in the heart, and the implant is safely released by operating the first sub-tube 121 control device and the second sub-tube 122 control device.

[0065] In summary, this invention provides a catheter assembly, an implant system, an implant delivery system, and a method of use thereof. It employs a delivery system with a fixed bending angle for implanting artificial valves. The implant delivery system of this invention has low requirements for surgical incisions and features bending capabilities, enabling accurate delivery of the stent to the designated location. Furthermore, the guidewire and outer sheath used for bending control are divided into two parts: a straight section and a bent section, which are detachably connected, significantly reducing costs and improving the compatibility of the straight section of the catheter assembly. Based on a simple structural design and fewer components, this invention achieves controlled bending of the delivery system and offers advantages such as simple operation and high safety and reliability.

[0066] Furthermore, it should be noted that, unless otherwise specified or indicated, the terms "first" and "second" in the specification are used only to distinguish the various components, elements, steps, etc. in the specification, and not to indicate the logical or sequential relationships between the various components, elements, steps, etc.

[0067] It is understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A catheter assembly, characterized in that, It includes an outer sheath, an inner tube, and a guide wire, which are sequentially connected from the outside to the inside. The inner tube is made of an elastic material, while the outer sheath and the guide wire are made of malleable materials. The distal ends of the outer sheath and the guide wire are both shaped into a curved shape and provide a curved channel to the inner tube. The inner tube is elastically inserted into the curved channel. The outer sheath includes a first straight pipe section and a first bent pipe section arranged along the axial direction. The first straight pipe section is located at the proximal end of the outer sheath, and the first bent pipe section is located at the distal end of the outer sheath. The distal end of the first straight pipe section is connected to the proximal end of the first bent pipe section. The guide wire tube includes a second straight tube section, a second bent tube section and a third straight tube section arranged sequentially along the axial direction. The second straight tube section is located at the proximal end of the guide wire tube, and the third straight tube section is located at the distal end of the guide wire tube. The distal end of the second straight tube section is connected to the proximal end of the second bent tube section. The first bent tube section has a bending angle. The first straight pipe section is fitted outside the second straight pipe section, the first bent pipe section is fitted outside the second bent pipe section, the second bent pipe section has a bending angle, and the bending angle of the first bent pipe section and the bending angle of the second bent pipe section are the same.

2. The catheter assembly as claimed in claim 1, characterized in that, The outer sheath is made of a polymer material, and the polymer material has a Shore D hardness of 70HD~90HD; or... The outer sheath is made of a metal material with a Rockwell hardness of 20 HRC to 50 HRC.

3. The catheter assembly as claimed in claim 1, characterized in that, The guidewire is made of a polymer material with a Shore D hardness of 70HD to 90HD; or... The guide wire is made of metal, and the Rockwell hardness of the metal is 20 HRC to 50 HRC.

4. The catheter assembly as claimed in claim 2 or 3, characterized in that, The polymer material includes PA, PI or PEEK; the metal material includes 304 stainless steel or 316 stainless steel.

5. The catheter assembly as claimed in claim 1, characterized in that, The inner tube is made of Pebax, TPU, LDPE, NR or NBR, and its Shore D hardness is 40 HD to 70 HD.

6. The catheter assembly as claimed in claim 1, characterized in that, The distal end of the first straight pipe section is detachably connected to the proximal end of the first bent pipe section.

7. The catheter assembly as claimed in claim 1, characterized in that, The distal end of the second straight pipe section is detachably connected to the proximal end of the second bend pipe section.

8. An implant delivery system, characterized in that, The catheter assembly includes any one of claims 1 to 7, and a delivery handle disposed at the proximal end of the catheter assembly. The delivery handle includes an outer sheath control device, an inner tube control device, and a guidewire fixation device. The outer sheath control device is connected to the proximal end of the outer sheath and is used to control the axial movement of the outer sheath. The inner tube control device is connected to the proximal end of the inner tube and is used to control the axial movement of the inner tube. The guidewire fixation device is connected to the proximal end of the guidewire.

9. An implant system, characterized in that, The device includes a catheter assembly, a delivery handle, a conical head, and a fixation head as described in any one of claims 1 to 7, wherein the fixation head and the conical head are sequentially disposed from proximal to distal end of the inner tube, the implant is held within the inner tube, and at least a majority of the implant is confined between the conical head and the fixation head.

Images