CN110179566B - Prosthesis conveying system with positioning function - Google Patents

Abstract

The utility model relates to a prosthesis conveying system with locate function, prosthesis conveying system includes artificial prosthesis, sheath pipe, fixed pipe, positioner and mounting, the fixed pipe is set up in the sheath pipe, positioner have preset shape and with the distal end of fixed pipe is connected, positioner pass through the mounting with artificial prosthesis can dismantle the connection, positioner has two kinds of forms, and first form is positioner is loaded to be restricted in the distal end portion of sheath pipe, and the second form is positioner is followed the distal end of sheath pipe stretches out and resumes to preset shape, be provided with supporting region and anchor region on the positioner do not set up skeleton texture in the anchor region. The system solves the problems that the existing implantation instrument has no whole-course positioning function in the process of releasing the implant, damages tissues in the positioning process, causes collateral damage due to the use of large-dose contrast agent and overlong radiation exposure time, and the like.

Description

Prosthesis conveying system with positioning function

Technical Field

The invention belongs to the field of medical appliances, relates to a prosthesis conveying system with a positioning function, and particularly relates to a prosthesis conveying system with a positioning function for treating heart valve regurgitation.

Background

With the advent of aging population, the incidence of heart valve disease has increased significantly. In particular mitral regurgitation (mitral regurgitation, MR), is more than 5 times more frequent than patients with aortic stenosis. It is estimated that there are over 1000 tens of thousands of severe MR patients in our country. MR is the result of the mitral valve leaflet and its structure changing causing the anterior and posterior She Wenge of the mitral valve to be poor and the blood flowing back from the left ventricle to the left atrium, causing some symptoms. MR can be classified into primary (organic) and secondary (functional) based on pathogenesis, with about 50% each. Mild MR patients can develop no clinical symptoms for a long time, with a better prognosis. Severe MR patients may be accompanied by symptoms such as palpitations, chest distress, and shortness of breath. Acute severe MR patients are poorly tolerated and die easily. Clinical studies have shown that only patient symptoms can be ameliorated by drug treatment, and that the survival time or surgical timing cannot be prolonged. Surgical valve repair or replacement is recognized as a standard method of treating MR and has been demonstrated to alleviate symptoms and extend survival in patients. However, surgical treatment has the disadvantages of large trauma, slow postoperative recovery, obvious postoperative pain, high risk, and the like. Meanwhile, 50% of MR patients cannot be effectively treated because of the inapplicable surgical operations due to the high risk factors such as hypocardiac function, advanced age, history of chest opening, etc. Over the last decade, the rapid development of transcatheter mitral valve interventional techniques, particularly MitraClip, has brought promise to many patients. Recent studies indicate that MitraClip has better therapeutic effects on functional reflux than drug therapy. Facing a huge market, large enterprises and capital disputes are in the line of MR treatment.

As such, MR therapy is emerging in the era of interventional procedures after undergoing traditional surgical thoracotomy and minimally invasive small incision surgery. The treatment mode of the interventional heart valve has the advantage of small trauma compared with the traditional treatment, and brings hopes for high-risk patients unsuitable for surgical operation. Although the therapeutic approach of interventional heart valves has many advantages over traditional therapies, it is faced with a number of technical challenges, such as difficult positioning. The difficulty in positioning presents a risk to interventional procedures, and in order to obtain a clear image, the patient is required to use the contrast agent multiple times during surgery, so that the patient is exposed to the harm of the contrast agent. The accumulated radiation quantity of the patient is excessive due to the repeated and large-dose X-rays, and the damage of radiation injury is faced. If the released implant is not positioned perfectly or displaced or even falls off due to positioning problems, the patient may be at risk of re-performing a conventional open chest procedure, which is seriously life threatening. Therefore, the technique of ensuring the timely and accurate positioning of the implant has great clinical value for interventional operations.

Currently, the only transcatheter interventional device approved for use in the treatment of MR internationally is the MitraClip by Abbott corporation. The design principle is derived from the edge-to-edge suturing technology in the surgical valve operation. When the heart contracts, the anterior and posterior leaflet edges of the mitral valve fail to coapt, thereby creating a gap from which blood flow from the left ventricle back to the left atrium. The surgical edge-to-edge technique is to suture the middle point of the anterior and posterior leaflet edges of the mitral valve so that the mitral valve changes from one large orifice to two small orifices, thereby reducing MR. In actual operation, the MitraClip control system is complex, the operation route is long, the channels are bent more, a doctor is required to repeatedly fine tune the bending degree, the direction, the release depth and the like of the conveying system, and the valve leaflet can be clamped after a plurality of attempts, so that the operation time is long. The function of quick positioning to the clamping position is lacking.

Patent CN106175986a discloses a valve clamp for treating regurgitation of a heart valve, wherein the first clamping arm and the second clamping arm can clamp objects therein by mutual forces generated by mutual approaching and pressing. It can be seen that it is difficult to capture the leaflets by simply bringing them together, and that the compression can cause damage to the leaflets. Also, the lack of rapid positioning and leaflet capturing functions and the susceptibility to damage to the leaflets.

Patent CN106606381a discloses an artificial heart valve positioning device, which retracts a positioning frame after the valve is released to a certain extent, and then continues to complete the release of the valve. The problem with this design is that the spacer cannot be retracted after the valve has been released, otherwise the spacer interferes with the released valve, affecting the subsequent release of the valve. The positioning frame cannot ensure that the valve is positioned in the whole process of releasing the valve, and if the position of the valve is changed after the positioning frame is recovered, the problem of incorrect positioning of the implant still exists.

Accordingly, those skilled in the art have been motivated to develop a delivery system with positioning functionality that, on the one hand, enables precise positioning throughout the process of releasing the implant; on the other hand, the operation time of the apparatus can be reduced, so that the dosage and the radiation quantity of the contrast agent are reduced, and the collateral damage to a patient is avoided.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a prosthesis conveying system with a positioning function for patients with mitral insufficiency and needing interventional treatment. The invention solves the problems that the existing implantation instrument has no positioning function in the process of releasing the implant, or has no whole-course positioning function, damages tissues in the positioning process, causes collateral damage due to the use of large-dose contrast agent and overlong radiation exposure time, and the like.

The invention aims at realizing the following scheme:

the utility model provides a prosthesis conveying system with locate function, includes artificial prosthesis, sheath pipe, fixed pipe, positioner and mounting, the fixed pipe is set up in the sheath pipe, positioner have preset shape and with the distal end of fixed pipe is connected, positioner pass through the mounting with artificial prosthesis can dismantle the connection, positioner has two kinds of forms, and first form is positioner is loaded to be restricted in the distal end portion of sheath pipe, and the second form is positioner is followed the distal end of sheath pipe stretches out and resumes to preset shape, be provided with support region and anchor region on the positioner the anchor region does not set up skeleton texture in the anchor region.

The aim of the invention can be further realized by the following technical scheme:

in one embodiment, the prosthesis delivery system further comprises an anchoring unit having two configurations, a first configuration in which the anchoring unit is constrained within the sheath and a second configuration in which a distal portion of the anchoring unit is fully released from the sheath, the projected point of the outlet of the anchoring unit being located within the anchoring region when the anchoring unit is in the second configuration.

In a preferred embodiment, a limiting structure is provided between the anchoring unit and the fixed tube. More preferably, the limit structure is a guide rail structure.

In one embodiment, a skeleton structure is provided at the support region of the positioning device, the skeleton structure comprising two main supports and at least one auxiliary support, the main supports being provided at the interface of the support region and the anchoring region. More preferably, the included angle between the two main supporting pieces is 45-180 degrees, and the number of the auxiliary supporting pieces is 1-7.

In a preferred embodiment, the main support is shaped as a convolution, an arc, a Y-shape, or the like.

In a preferred embodiment, the skeleton is radially distributed when the positioning device is in the second configuration. More preferably, the skeleton is integrally processed from a memory alloy material.

In a preferred embodiment, the anchoring region is fan-shaped, circular or oval, etc.

In a preferred embodiment, the primary support and the secondary support are provided with cushioning structures thereon.

In a more preferred embodiment, the cushioning structure is S-shaped, wavy, oval, saw-tooth shaped, or the cushioning structure is a flexible material wrapped over the free ends of the primary and secondary supports. More preferably, the flexible material is bovine pericardium/porcine pericardium.

In a preferred embodiment, a cover film is provided between the main support and the auxiliary support. More preferably, the material of the coating is polytetrafluoroethylene or terylene.

Preferably, the anchor extends radially to the distal end of the armature.

In one embodiment, the securing member is a wire member. In a preferred embodiment, the wire member is made of nickel titanium alloy wire having a diameter of 0.2mm to 0.5 mm.

In one embodiment, the prosthetic is a valve repair instrument that may be used for mitral valve repair or tricuspid valve repair.

In a preferred embodiment, the prosthesis is detachably connected to the main support by means of the fixing element.

In a more preferred embodiment, the prosthesis is provided with a connector, the main support is provided with a hole structure, the connector passes through the hole structure, and the fixing element passes through the connector.

In one embodiment, a skeleton structure is arranged on the positioning device, the skeleton structure comprises a main support piece and an auxiliary support piece, and a clamping structure is further arranged at the bottom of the positioning device. In a preferred embodiment, the detent structure is a chuck or a rod.

In one embodiment, the positioning device is fixedly connected with the distal end of the fixed tube in a welding and bonding mode, or the positioning device is detachably connected with the distal end of the fixed tube.

In one embodiment, the anchoring unit includes an anchoring channel, an anchor, and a release. The cross section of the anchoring channel is circular, elliptic and the like. The anchoring piece is an anchoring screw, an anchoring needle and the like. The release member is freely movable within the anchor channel for releasing the anchor.

Compared with the prior art, the invention has the advantages that:

1. the positioning device can realize real-time positioning in the artificial prosthesis releasing process. The positioning device does not interfere with the release and anchoring of the artificial prosthesis, so that the positioning device does not need to be recovered before the artificial prosthesis is released, and the problem that the release position of the artificial prosthesis is possibly changed due to the fact that the positioning device is recovered first and then the artificial prosthesis is released after the positioning in the prior art is completed is avoided.

2. The prosthesis conveying system with the positioning function also comprises an anchoring unit, wherein the anchoring unit has two forms, the first form is that the anchoring unit is limited in the sheath, the second form is that the anchoring unit is completely released from the sheath, and when the anchoring unit is in the second form, the projection point of the outlet of the anchoring unit is positioned in the anchoring area, so that the accuracy and the adjustability of the anchoring position can be ensured.

3. The positioning device can position the heart tissue by only being abutted against the tissue without clamping or grabbing the heart tissue, so that the damage to the tissue is avoided.

4. The prosthesis conveying system can realize the positioning function only by being abutted against heart tissues, has simple operation process and shortens the positioning time.

Drawings

Fig. 1 is a schematic view of the distal portion of the prosthesis delivery system of the present invention.

Fig. 2 is a schematic structural view of one embodiment of a positioning device of the prosthesis delivery system of the present invention.

Fig. 3 is a schematic view of another embodiment of a positioning device of the prosthesis delivery system of the present invention.

Fig. 4 is a schematic view of a further embodiment of a positioning device of the prosthesis delivery system of the present invention.

Fig. 5 is a schematic view of a spacing structure of the prosthesis delivery system of the present invention.

Fig. 6 a-6 b are schematic views of the detachable connection of a prosthesis to a positioning device of the prosthesis delivery system of the present invention.

Fig. 7 a-7 c are schematic structural views of another embodiment of a positioning device of the prosthesis delivery system of the present invention.

Fig. 8 a-8 e are schematic views of the operational steps of the prosthesis delivery system of the present invention.

The specific embodiment is as follows:

in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail below by referring to the accompanying drawings and examples.

The distal end refers to the end far away from the operator, and the proximal end refers to the end near the operator.

In one embodiment, as shown in fig. 1, a prosthesis delivery system 100 with positioning function includes an artificial prosthesis 110, a sheath 120, a fixing tube 130 disposed in the sheath 120, a positioning device 140 connected to a distal end of the fixing tube 130, and a fixing member 150, the positioning device 140 having a predetermined shape, the positioning device 140 being detachably connected to the artificial prosthesis 110 through the fixing member 150, the positioning device 140 having two forms, a first form in which the positioning device 140 is loaded and restricted in a compressed state in a distal end portion of the sheath 120, and a second form in which the positioning device 140 is protruded from the distal end of the sheath 120 to return to a released state of the predetermined shape, a support region 142 and an anchor region 141 being disposed on the positioning device 140, and no skeleton structure being disposed in the anchor region 141. The prosthetic 130 is a valve repair instrument that may be used for mitral valve repair or tricuspid valve repair. The positioning device 140 is fixedly connected with the distal end of the fixed tube 130 by welding or bonding, or the positioning device 140 is detachably connected with the distal end of the fixed tube 130. The delivery system further includes an anchoring unit 160, a guidewire tube 190, and a TIP head 180 fixedly coupled to the distal end of the guidewire tube 190, the anchoring unit 160 and the guidewire tube 190 being disposed within the sheath 120 in one embodiment. The projected point of the outlet of the anchoring unit 160 is located within the anchoring area 141. The anchoring unit 160 has two configurations, a first configuration in which the anchoring unit 160 is constrained within the sheath 120, and a second configuration in which a distal portion of the anchoring unit 160 is fully released from the sheath 120, and a projected point of an outlet of the anchoring unit 160 is located within the anchoring region 141 when the anchoring unit 160 is in the second configuration. The projected point of the outlet of the anchoring unit 160 refers to the orthographic projection formed parallel to the plane of the patient's annulus. The distal portion of the anchoring unit is made of a shape memory material having a predetermined shape, which in one embodiment is 180 ° bent hook-like. When the distal end portion of the anchoring unit 160 is completely released from the sheath 120, the distal end portion of the anchoring unit resumes a preset shape such that the forward projection point of the distal outlet of the anchoring unit 160 formed on the plane of the patient's annulus is located within the anchoring region 141, i.e. the distal outlet of the anchoring unit 160 is aligned with the anchoring region 141, which structural design is capable of ensuring the accuracy of the anchoring position. In another embodiment, the anchoring unit includes an anchoring channel, an anchor, and a release. The cross section of the anchoring channel is circular, elliptic and the like. An anchor is placed within the anchor channel with a release member, the distal end of the release member abutting the proximal end of the anchor, the anchor being an anchor screw, an anchor needle, or the like. The release member is freely movable within the anchor channel for releasing the anchor. The distal end portion of the anchoring unit 160 is bendable, an adjusting wire is further disposed in the anchoring unit 160, the distal end of the adjusting wire is fixedly connected with the distal end of the anchoring unit 160, the proximal end of the adjusting wire extends out of the body, an operator can adjust the bending angle of the distal end of the anchoring unit by operating the adjusting wire, and a projection point of an outlet of the anchoring unit 160 is located in the anchoring area 141.

In one embodiment, as shown in fig. 2, the support area 142 of the positioning device 140 is provided with a skeleton structure, which includes two main supports 1421 and one auxiliary support 1422, and the main supports 1421 are disposed at the interface between the support area 142 and the anchoring area 141. The anchor region 141 is fan-shaped. The included angle between the two main supports 1421 is 45 ° to 180 °. The main support bar 1421 is a straight bar. In one embodiment, the main support bar is convoluted or Y-shaped or the like (not shown). In one embodiment, as shown in fig. 3, the skeletal structure is integrally machined from a memory alloy and includes two main supports 1421 and seven auxiliary supports 1422. When the positioning device 140 is in the second configuration, the skeleton structure is radially distributed. The angle between the two main supports 1421 is 88 °. The area between the two main supports 1421 constitutes the anchoring area 141, and the anchoring area 141 is fan-shaped. The two main supporting members 1421 are provided with hole-shaped structures 1423, and the hole-shaped structures 1423 are elliptical holes. A covering membrane 1425 is disposed between the main support 1421 and the auxiliary support 1422, the covering membrane 1425 is made of polytetrafluoroethylene, and the covering membrane 1425 is pressed on the framework structure at high temperature. A cushioning structure 1424 is disposed on the auxiliary support 1422, and the cushioning structure 1424 is zigzag. In another embodiment, the buffer structure 1424 is S-shaped, wavy, oval, or zigzag.

In another embodiment, as shown in fig. 4, the skeletal structure is integrally machined from a memory alloy and includes two main supports 1421 and three auxiliary supports 1422. The two main support bars 1421 are arc-shaped, and when the positioning device 140 is in the second configuration, the two main support bars 1421 are radially stretched and released. The two main support members 1421 define a circular anchor region 141 therebetween. In one embodiment, the two main support members 1421 define an oval anchor region 141 therebetween. A hole-like structure 1423 is disposed on the ends of the two main support members 1421, and the hole-like structure 1423 is a circular hole. A covering film 1425 is disposed between the main support 1421 and the auxiliary support 1422, the covering film 1414 is made of a polyester material, and the polyester material is connected with the framework structure through a suture line. A cushioning structure 1424 is disposed on the auxiliary support 1422, and the cushioning structure 1424 is a flexible material wrapped around the free end of the auxiliary support 1422. The flexible material is bovine pericardium or porcine pericardium.

In one embodiment, as shown in fig. 5. The positioning device 140 with the anchoring area 141 is connected with the fixed pipe 130 by welding, etc., a limit structure 170 is disposed between the anchoring unit 160 and the fixed pipe 130, and the limit structure 170 is a guide rail structure, so as to limit the rotation of the anchoring unit 160, and the anchoring unit 160 can only move along the axial direction of the fixed pipe 130. The purpose of the stop structure 170 is to ensure that the projected point of the outlet of the anchoring unit 160 is located within the anchoring area 141, i.e. to limit the relative position of the anchoring area 141 and the projected point of the outlet of the anchoring unit 160. Because the plane of the axis of the anchoring unit 160 is perpendicular to the plane of the anchoring area 141, the position of the anchoring area 141 can be determined in an assisted manner during development, so as to realize rapid and accurate positioning and anchoring, and solve the problems that the positioning device cannot be positioned in real time in the whole process in the prior art, and the positions of the positioning device and the implant cannot be fixed relatively before the release is completed. The fixing piece 150 is a wire piece, and the fixing piece 150 is made of nickel-titanium alloy wires with the diameter of 0.2mm-0.5 mm. One end of the fixing member 150 is detachably connected with the positioning device 140, and the other end of the fixing member 150 extends out of the body or is fixedly connected with a handle of the conveying system. The anchor 150 extends radially through the distal end of the anchor tube 130 to the distal end of the backbone 141.

In another embodiment, as shown in fig. 6 a. The skeletal structure includes a primary support 1421 and a secondary support 1422. The distal end of the main support 1421 has a rounded design to prevent unnecessary damage to the patient's heart tissue during positioning. The distal end of the auxiliary support member 1422 has a rounded and upturned structure, so that the outer side of the distal end of the auxiliary support member 1422 is not damaged when contacting with heart tissue. The prosthesis 110 is removably coupled to the main support 1421 via fasteners 150. The detachable connection may be achieved by: the artificial prosthesis 110 is provided with a connecting piece 111, the main support 1421 is provided with a hole-shaped structure 1423, the connecting piece 111 penetrates out of the hole-shaped structure 1423, and the fixing piece 150 penetrates through the connecting piece 111, so that the artificial prosthesis 110 is fixed on the positioning device 140. When the prosthetic 110 is released and anchoring is complete, the proximal end of the anchor 150 is pulled to effect separation of the prosthetic 110 and the positioning device 140. In a preferred embodiment, the connector 111 is a circular ring 112, or the connector is an n-shaped structure.

In another embodiment, as shown in fig. 6 b. The artificial prosthesis 110 is a flexible strip, and the artificial prosthesis 110 is provided with a circular ring 112. The prosthesis 110 is removably coupled to the main support 1421 via fasteners 150. The detachable connection may be achieved by: the main support 1421 is provided with a hole-shaped structure 1423, the circular ring 112 passes through the hole-shaped structure 1423, and the fixing member 150 passes through the circular ring 112, so that the prosthesis 110 is fixed on the positioning device 140. When the prosthetic 110 is released and anchoring is complete, the proximal end of the anchor 150 is pulled to effect separation of the prosthetic 110 and the positioning device 140.

In another embodiment, as shown in fig. 7 a. A skeleton structure is provided on the positioning device 140, and the skeleton structure includes a main support 1421 and an auxiliary support 1422. A clamping structure is further disposed at the bottom of the positioning device 140. In a preferred embodiment, the detent structure is a chuck 1401. The chuck 1401 is braided from a memory alloy wire, which may be a nitinol wire having a diameter of 0.25mm-0.4mm. The chuck 1401 is securely coupled to the main support 1421 and the auxiliary support 1422 by tantalum rings 1402. In a preferred embodiment, as shown in fig. 7 b. The detent structure is a lever, which is an "L" shaped lever 1403. Because the L-shaped rod 1403 and the framework structure are formed by cutting the same nickel-titanium alloy pipe, one end of the L-shaped rod 1403 is naturally connected with the framework structure, and the L-shaped rod 1403 is formed after heat treatment. The other end of the "L" shaped rod 1403 is securely connected to the primary support 1421 or secondary support 1422 by tantalum ring 1402. In another preferred embodiment, as shown in FIG. 7c, the detent structure is a lever that is an "L" shaped double lever 1404. Because the L-shaped double rod 1404 and the framework structure are cut from the same nickel-titanium alloy pipe, one end of the L-shaped double rod 1404 is naturally connected with the framework structure, and the L-shaped double rod 1404 is formed after heat treatment. The other end of the "L" shaped double bar 1404 is a free end. Between the "L" shaped double bars 1404 is an abutment region 1405, in a preferred embodiment an auxiliary support bracket is provided within the abutment region 1405. The abutment region 1405 is also covered with a film made of polyester or polytetrafluoroethylene. Preferably, the membrane covers the auxiliary support stent. The clamping structure can better position the anchor point and provide position feedback for doctor operation.

Fig. 8 a-8 e illustrate the steps of the prosthesis delivery system 100 to release the prosthesis 110. The prosthetic delivery system 100 is advanced through the apex approach to a position on the atrial side of the mitral valve, with the distal end of the prosthetic delivery system 100 being positioned over the mitral valve annulus as determined by imaging. Moving the sheath 120 releases the positioning device 140, places the positioning device 140 against the mitral valve annulus, visualizes and rotates the prosthesis delivery system 100, adjusts the positioning device 140 position such that the anchoring area 141 is located in the middle of the posterior mitral valve annulus, at which time the positioning of the prosthesis 110 is completed. The anchoring unit 160 is pulled down, anchoring the outlet of the anchoring unit 160 against the anchoring region 141. After anchoring is complete, the anchor 150 is withdrawn, and the positioning device 140 is separated from the prosthesis 110. Moving the sheath 120 to take up the sheath and finally withdrawing the prosthesis delivery system 100 from the body to complete the implantation of the prosthesis 110. As can be seen from the above operation steps, the prosthesis delivery system of the invention can realize the positioning function only by being abutted against heart tissue, has simple operation process, shortens the positioning time and reduces the operation risk.

Finally, it should be understood that the foregoing description is merely illustrative of the preferred embodiments of the present invention, and that no limitations are intended to the scope of the invention, as defined by the appended claims.

Claims (9)

1. A prosthesis delivery system with positioning function, characterized in that it comprises an artificial prosthesis, a sheath, a fixing tube, a positioning device, a fixing member and an anchoring unit, wherein the fixing tube is arranged in the sheath, the positioning device has a preset shape and is connected with the distal end of the fixing tube, the positioning device is detachably connected with the artificial prosthesis through the fixing member, the positioning device has two forms, the first form is that the positioning device is loaded and limited in the distal end part of the sheath, the second form is that the positioning device stretches out from the distal end of the sheath to restore to the preset shape, the positioning device is provided with a supporting area and an anchoring area, the supporting area of the positioning device is provided with a skeleton structure, the skeleton structure comprises two main supporting members and at least one auxiliary supporting member, the main supporting member is arranged at the position of the supporting area and the anchoring area, the skeleton structure is not arranged in the anchoring area, the second form is that the anchoring unit is completely released from the distal end of the sheath, and the second form is that the anchoring unit is completely released in the position of the sheath.

2. The prosthesis delivery system with positioning function of claim 1, wherein a spacing structure is provided between the anchoring unit and the fixation tube.

3. The positioning function of a prosthesis delivery system of claim 1, wherein the angle between the two main support members is 45 ° to 180 °.

4. The positioning function of a prosthesis delivery system of claim 1, wherein the primary support member and the secondary support member are provided with cushioning structures.

5. The prosthesis delivery system with positioning function of claim 1, wherein a covering membrane is disposed between the primary support and the auxiliary support.

6. The positioning function of a prosthesis delivery system of claim 1, wherein the anchor is a wire member extending radially to the distal end of the main support member.

7. The prosthesis delivery system with positioning function of claim 6, wherein a connector is provided on the prosthesis and a hole structure is provided on the main support, the connector is threaded out of the hole structure, and the fixture is threaded through the connector so that the prosthesis is detachably connected with the main support.

8. The prosthesis delivery system with positioning function according to claim 1, wherein a skeleton structure is provided on the positioning device, the skeleton structure comprising a main support and an auxiliary support, and a clamping structure is further provided at the bottom of the positioning device.

9. The prosthesis delivery system with positioning function according to claim 1, wherein the anchoring unit comprises an anchoring channel, an anchoring member and a releasing member, the anchoring channel being circular or elliptical in cross section, the anchoring member being an anchoring screw or an anchoring needle, the releasing member being freely movable within the anchoring channel for releasing the anchoring member.