CN115737208A - Implant instrument conveying system capable of being accurately regulated and controlled - Google Patents

Abstract

The application relates to the field of medical instruments, in particular to an implantation instrument conveying system capable of being accurately regulated and controlled, which comprises a control mechanism, a bending adjusting pipe fitting, a control line, a fixing piece and a connecting piece, wherein the connecting piece is rotatably connected to the far end of the fixing piece, the fixing piece is provided with a guide channel, the near end of the control line is connected with the control mechanism, the far end of the control line passes through the guide channel and is connected with the connecting piece, the near end of the fixing piece is connected with the far end of the bending adjusting pipe fitting, the control mechanism comprises a rotation adjusting piece, a bending adjusting control piece and a bending adjusting track, the near end of the control line is connected with the rotation adjusting piece, and when the rotation adjusting piece is rotated, the control line pulls the connecting piece to rotate circumferentially relative to the fixing piece; when the adjusting piece is fixedly rotated and the bending adjusting control piece is pulled to enable the bending adjusting control piece to slide along the bending adjusting track, the bending adjusting pipe fitting is bent; the invention can realize the adjustment of the circumferential position of the prosthesis and the adjustment of the curvature of the bending pipe fitting, is convenient to operate and has good clinical significance.

Description

Implant apparatus conveying system capable of being accurately regulated and controlled

Technical Field

The application relates to the field of medical equipment, in particular to an implanted equipment conveying system capable of being accurately regulated and controlled.

Background

Aortic Stenosis (AS) is one of the common valvular diseases, with a 4.6% incidence rate in people over 75 years of age in the united states, and the third most common cardiovascular disease in the united states following coronary heart disease and hypertension. Surgical aortic valve replacement has long been the only therapy recognized as long-term effective. Nevertheless, based on high risk assessment of surgery and concern for postoperative complications, there are still 1/3-2/3 patients who abandon surgical treatment, so patient mortality averages 50% -60% per year once symptoms appear. Due to continuous innovation of heart intervention means and medical instruments, medical catheter treatment, especially Percutaneous Aortic Valve Replacement (PAVR) gradually becomes a mainstream operation mode, and clinical tests prove that the medical catheter treatment is simple, convenient and feasible, and brings good news to patients who cannot receive surgical treatment.

The main options for percutaneous aortic valve replacement currently available are three surgical approaches, namely the anterior (transfemoral and interatrial puncture), the reverse (retrograde entry into the aortic arch via the femoral artery) and the non-extracorporeal direct access valve replacement (transapical), the second of which is the most convenient and rapid technique and is widely used. The existing stent positioning devices in the market represent an Edwards balloon-expanded SAPIEN (save artificial artery and advanced artery) valve stent positioning device and a Corevalve self-expanding ReValling valve stent positioning device, and research and development personnel continuously provide technical schemes and instrument innovations so as to improve the survival rate of patients and improve the living condition of the patients.

Nevertheless, PAVR still has many defects and technical problems in many aspects such as selection of target population, long-term curative effect and postoperative complications, etc. which are not solved or overcome. Researches show that the improvement of the valve stent positioning device and the operation technology plays a vital role in inhibiting complications such as aortic perforation, paravalvular leakage, thrombus, cerebral apoplexy and the like. For example, in patent CN202110647777.7, a rotatably adjustable positioning device is disclosed in the patent solution, which includes: a fixing member; a generally lengthwise extending coupling mechanism rotatably coupled distal to the mount; at least one steering wire; wherein, the fixed part is provided with a guide channel; one end of the control wire is connected to the connecting mechanism, and the other end of the control wire passes through the corresponding guide channel and is connected to the control mechanism; and wherein manipulation of the steering wires by the steering mechanism causes rotation of the attachment mechanism relative to the fixed member, thereby effecting adjustment of the circumferential position of the attachment mechanism and the component associated therewith. Through dragging the contained angle that the adjustable link of control line and guide channel become on the cross section of mounting, the overwhelming majority of pulling force all concentrates on between guide channel and the link, and the loss is minimum, and very timely to the feedback of adjusting, and the precision is high. The defect of this scheme lies in, artificial valve is at the in-process of implanting, not only need the position of circumference adjustment valve, it can the centering to also make its valve to transfer the bending simultaneously, this scheme can promote the precision of circumferential location regulation and control to artificial valve by a wide margin through the mode of drive-by-wire, but does not possess the function of transferring the bending centering, and present conveying system is through the mode of drive-by-wire come to transfer the bending and centering function to the valve, but the easy mutual interference in sheath pipe content is all integrated to many drive-by-wires, lead to probably the unfavorable condition to appear when regulating and control, simultaneously, many drive-by-wires have also occupied the space of sheath pipe, be unfavorable for passing through vascular entry.

Accordingly, there is a pressing need in the art for a positioning system for an implant device, such as a valve, that does not interfere with the associated features, that provides for higher integration of the components within the sheath, that is simpler to operate, that provides more precise positioning, that provides fewer surgical complications, and that provides for shorter surgical time.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

It is an object of the present application to overcome the deficiencies of the prior art by providing a novel precisely controllable delivery system for an implanted device for a patient suffering from a cardiovascular disease, such as aortic stenosis, for example, and in need of an interventional procedure.

The technical scheme adopted for solving the technical problem of the invention is that a precisely regulated and controllable implantation instrument conveying system is provided, which comprises: the steering mechanism comprises a rotating adjusting piece, a bending adjusting piece connected with the rotating adjusting piece and a bending adjusting track matched with the bending adjusting piece, wherein the steering wire pulls the joint piece to rotate circumferentially relative to the fixed piece when the rotating adjusting piece is rotated; when the rotating adjusting piece is fixed and the bending adjusting control piece is pulled, so that the bending adjusting control piece slides along the bending adjusting track, the operating wire pulls the joint piece and drives the bending adjusting pipe piece to bend.

As a further improvement of the present invention, a connecting portion is disposed on the linking member, a distal end of the operating wire is connected to the connecting portion, and an included angle is preset between a connecting line formed from a center of the connecting portion to a center of the linking member and a connecting line formed from a center of the guiding channel to a center of the fixing member.

As a further improvement of the invention, the joining piece is provided with a first connecting part and a second connecting part, and the first connecting part and the second connecting part are symmetrically arranged on two sides of the guide channel.

As another embodiment of the present invention, the guide channel includes a first channel and a second channel, wherein the first channel and the second channel are symmetrically disposed at both sides of the connection point portion.

As a further improvement of the present invention, the steering wire includes a first steering wire and a second steering wire, when the rotation adjusting member is rotated, an effective stroke of the first steering wire or the second steering wire (the effective stroke refers to a stroke from a position of the steering wire at the connecting portion to a position of the rotation adjusting member, excluding a part of a length of the steering wire which is curled and stored) is shortened and the joint member is driven to rotate circumferentially; when the rotary adjusting piece is fixed and the bending adjusting control piece is pulled to enable the bending adjusting control piece to slide along the bending adjusting track, the effective stroke of the first operating wire and the second operating wire is kept unchanged and the bending adjusting pipe piece is driven to bend.

As a further improvement of the invention, the bending adjusting pipe member is provided with a slit for adjusting curvature, and when the rotating adjusting member is fixed and the bending adjusting control member is pulled so that the bending adjusting control member slides along the bending adjusting track, the first operating wire and the second operating wire simultaneously pull the connecting portion so that the distal end of the bending adjusting pipe member is stressed, and the bending adjusting pipe member is bent.

As a further improvement of the present invention, the rotation adjusting member comprises a wire winding rod and a control knob, the proximal ends of the first and second manipulating wires are respectively connected with the wire winding rod, wherein when the control knob is rotated clockwise, the first manipulating wire is in a tensioned state and further drives the joint member to rotate clockwise, and the second manipulating wire is also pulled close and is always in a tensioned state due to the clockwise rotation of the joint member; when the control knob is rotated anticlockwise, the second control wire is in a tensioned state and further drives the joint piece to rotate anticlockwise, and the first control wire is also in a tensioned state.

As a further improvement of the present invention, the bending adjustment control member includes a slider connected to the rotation adjustment member and a locking device disposed on the slider, wherein a positioning hole matched with the locking device is disposed in the bending adjustment track.

As a further improvement of the invention, the bending adjusting track is provided with bending adjusting marks corresponding to the positioning holes, the bending adjusting marks have 30 scales for adjusting the curvature radius of the bending adjusting pipe fitting, and the curvature radius of the bending adjusting pipe fitting is 40-70 degrees, wherein when the sliding block is pulled, the locking device slides out of the positioning hole and enters the next positioning hole to realize locking.

As a further improvement of the present invention, the locking device includes a spring and a ball, the ball is matched with the positioning hole, one end of the spring is fixedly connected with the slider, and the other end of the spring is matched and connected with the ball.

As a further development of the invention, the shape of the fixing element is selected from one of the following: umbrella-cover, cylinder, frustum, prism and sleeve; the positioning of the guide channel is selected from at least one of: the guide channel is positioned in the fixing piece; and the guide channel is arranged at the periphery of the fixing member, and the guide channel is a substantially axially extending through-hole, channel, slot or rail arranged in the fixing member.

In a further development of the invention, the variable range of the angle of the rotatable adjustment of the connecting element is preset between-60 \65042and60 \65042.

As a further improvement of the invention, the far end of the joint piece is connected with a prosthetic heart valve prosthesis, and the prosthetic heart valve prosthesis is provided with 3 positioning pieces.

As a further development of the invention, the steering wire is selected from one of the following: a wire, a rope, a cable, a strand, a wire, a flexible band, and any combination thereof.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

although the existing conveying system has the function of bending and centering the valve in a wire-controlled manner, a plurality of wire-controlled wires are integrated in the sheath tube and are easy to interfere with each other, so that adverse conditions may occur during regulation and control, and meanwhile, the plurality of wire-controlled wires also occupy the space of the sheath tube and are not beneficial to entering through blood vessels. According to one concept of the application, when the rotary adjusting part is operated, one of the control wires can be pulled, so that the connecting part and the fixing part can rotate relatively, the circumferential position required by the valve prosthesis can be accurately adjusted and controlled, when the rotary adjusting part is fixed and the bending adjusting control part is pulled to enable the bending adjusting control part to slide along the bending adjusting track, the connecting part is pulled by 2 control wires simultaneously, the far end of the bending adjusting pipe is stressed and bent, circumferential adjustment can be achieved only by 2 control wires, bending adjustment of the bending adjusting pipe can be achieved, operation of an operator is facilitated, and mutual interference of the control wires in a sheath pipe can be avoided.

According to an idea of the application, bend adjusting operation and rotation operation are integrated on a control mechanism, the operation is convenient and the structure is simple, moreover, the design structure can further regulate and control the curvature of the bend adjusting pipe fitting and enable the valve prosthesis to be centered after the valve prosthesis is circumferentially rotated and adjusted, the operation is more accurate, and the design structure has good clinical significance.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

FIGS. 1 a-1 c are schematic views showing the overall construction of the delivery system of the implantation device of the present invention.

FIGS. 2 a-2 c are circumferential rotation views of a coupling element of the delivery system of the present invention.

Fig. 3 a-3 c are schematic views of a bend in the delivery system of the present invention, wherein fig. 3c is an enlarged view of a portion of fig. 3 a.

Fig. 4a to 4e are schematic views of different forms of fixing members according to the present invention.

Fig. 5 a-5 e are schematic views illustrating the operation of the delivery system of the present invention, wherein the dashed lines in fig. 5d illustrate the deviation of the center of the prosthetic valve from the center of the native valve.

The figures in the drawings indicate the following features:

1-a steering mechanism, 11-a rotation adjusting element, 111-a wire winding rod, 112-a control knob, 12-a bending control element, 121-a slider, 122-a locking device, 1221-a spring, 1222-a ball, 13-a bending track, 131-a positioning hole, 132-a bending adjusting mark, 2-a bending adjusting pipe element, 21-a cutting seam, 3-a control line, 31-a first control line, 32-a second control line, 4-a fixing element, 41-a guide channel, 5-a joint element, 51-a connecting part, 511-a first connecting part, 512-a second connecting part, and 6-a prosthetic valve prosthesis.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The present application will now be described in more detail with reference to various embodiments and examples of several aspects of the application.

In this application, the term "proximal" or "proximal" refers to the end or side closer to the operator, and "distal" or "distal" refers to the end or side farther from the operator.

One of the objects of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

Example one

As shown in fig. 1a to 1c, a precisely adjustable implant device delivery system for aortic valve surgery according to an embodiment of the present application is illustrated, comprising: the steering mechanism 1, the bending adjusting pipe member 2, a first steering wire 31, a second steering wire 32, a fixing member 4, a connecting member 5, a first connecting portion 51 and a second connecting portion 52 which are arranged on the connecting member 5, wherein the connecting member 5 is rotatably connected to the distal end of the fixing member 4, the fixing member 4 is provided with a guide channel 41, the proximal end of the steering wire 3 is connected with the steering mechanism 1, the distal end of the first steering wire 31 and the distal end of the second steering wire 32 respectively penetrate through the guide channel 41 and are respectively matched and connected with the first connecting portion 511 and the second connecting portion 512, the proximal end of the fixing member 4 is fixed with the distal end of the bending adjusting pipe member 2, the steering mechanism 1 comprises a rotation adjusting member 11, a bending adjusting control member 12 connected with the rotation adjusting member 11 and a bending adjusting track 13 matched with the bending adjusting control member 12, the rotation adjusting member 11 comprises a wire winding rod 111 and a control knob 112, the proximal ends of the first manipulating wire 31 and the second manipulating wire 32 are respectively connected with the wire winding rod 111, the bending adjusting control member 12 comprises a sliding block 121 connected with the rotation adjusting member 11 and a locking device 122 arranged on the sliding block 121, wherein a positioning hole 131 matched with the locking device 122 is arranged in the bending adjusting track 13, when the control knob 112 rotates clockwise, the first manipulating wire 31 is in a tightened state and further drives the connecting member 5 to rotate clockwise, and the second manipulating wire 32 is driven by the connecting member 5 and is in a tightened state; when the control knob 112 is rotated counterclockwise, the second manipulating wire 32 is in a tensioned state and further drives the joint member 5 to rotate counterclockwise, and the first manipulating wire 31 is also in a tensioned state (the same as the above-mentioned reason), as shown in fig. 2a to 2 c; after the circumferential position of the prosthetic valve prosthesis 6 is properly adjusted, the rotating adjusting member 11 is fixed and the control knob 112 is pulled to make the sliding block 121 slide along the bending adjusting track 13, as shown in fig. 3a and 3b, the first manipulating wire 31 and the second manipulating wire 32 simultaneously pull the joint member 5 and drive the bending adjusting tube member 2 to bend, as shown in fig. 3c, at this time, the forces applied to the first manipulating wire 31 and the second manipulating wire 32 are equal to make the distal end of the bending adjusting tube member 2 under the pulling force to achieve the adjustment of the curvature; in the invention, the control knob 112 is rotated to enable the first control wire 31 or the second control wire 32 to be partially wound into the winding rod 111, and relative rotation in circumferential position is generated between the connecting piece 5 and the fixing piece 4 to adjust the circumferential position of the artificial valve prosthesis 6, when the sheath curvature needs to be delivered, the control knob 112 is pulled to enable the sliding block 121 to slide along the bending adjusting track 13, and at the moment, the first control wire 31 and the second control wire 32 are simultaneously stressed and are subjected to equal tension to pull the bending of the distal end part of the bending adjusting pipe fitting 2, so that the adjustment of the curvature is realized.

In the present embodiment, the first connecting portion 51 and the second connecting portion 52 are symmetrically disposed at both sides of the guide passage 41.

In this embodiment, the bending adjusting tube member 2 is provided with a slit 21 for adjusting curvature, and when the rotating adjusting member 11 is fixed and the bending adjusting member 12 is pulled so that the bending adjusting member 12 slides along the bending adjusting track 13, the first operating wire 31 and the second operating wire 32 simultaneously pull the connecting portion 5 so that the distal end of the bending adjusting tube member 2 is stressed, and the bending adjusting tube member 2 is bent, as shown in fig. 3a to 3 c.

In this embodiment, the bending control member 12 includes a sliding block 121 connected to the rotation adjusting member 11 and a locking device 122 disposed on the sliding block 121, wherein a positioning hole 131 matched with the locking device 122 is disposed in the bending adjusting track 13.

In this embodiment, the bending adjustment track 13 is provided with a bending adjustment mark 132 corresponding to the positioning hole 131, as shown in fig. 3a, the bending adjustment mark 132 has 30 scales to adjust the curvature radius of the bending adjustment member 2, and the curvature radius of the bending adjustment member 2 is adjusted to be 40 to 70 °, wherein when the slider 121 is pulled, the locking device 122 slides out of the positioning hole 131 and enters the next positioning hole 131 to achieve locking, as shown in fig. 3 b.

In this embodiment, the locking device 122 includes a spring 1221 and a ball 1222, the ball 1222 is engaged with the positioning hole 131, one end of the spring 1221 is fixedly connected to the slider 121, and the other end is engaged with the ball 1222.

In the present embodiment, the shape of the fixing member 4 is selected from one of the following: canopy, cylinder, frustum, prism, and sleeve; the positioning of the guide channel 41 is selected from at least one of the following: the guide channel 41 is located in the fixing member 4; and the guide channel 41 are provided at the outer periphery of the fixing member 4, and the guide channel 41 is a substantially axially extending through-hole, channel, slot or rail provided in the fixing member 4, as shown in fig. 4a to 4 e.

In the present exemplary embodiment, the variable range of the angle of the rotatable adjustment of the connecting element 5 is intended to be between-60 \65042and60 \65042Ohw.

In the present embodiment, the distal end of the joint member 5 is connected to a prosthetic heart valve prosthesis, and the prosthetic heart valve prosthesis is provided with 3 positioning members.

The operation process of the implant device delivery system comprises the following steps.

1) The delivery system is operated to enter the heart by transvascular approach, and then the control knob 112 is slid to bend the bending tube member 2 to conform the curvature of the bending tube member 2 to the curvature of the side of the aortic arch as viewed by the effect, as shown in fig. 5 a.

2) Observing the current position of the positioning piece relative to the aortic sinus, if the position does not reach an ideal expected position, an operator can pull the corresponding control wire 3 by rotating the control knob 112, so that the control wire 3 drives the connecting piece 5 connected with the control wire to rotate, the connecting piece 5 drives the artificial valve prosthesis 6 to rotate together, and the position of the positioning piece of the artificial valve prosthesis 6 is adjusted, as shown in fig. 2a to 2c, 5b and 5c, while if the center of the artificial valve prosthesis 6 is observed to deviate from the center of the native valve more at the moment, the circumferential position of the artificial valve prosthesis 6 can be kept, and the control knob 112 is pulled to adjust the curvature of the bending pipe fitting 2, so that the positioning piece is finally positioned to the ideal expected position of the sinus floor, as shown in fig. 3a to 3c and 5 d.

3) When the locator reaches the desired location of the sinus floor, the stent body is further released from position. The positioner is then withdrawn and the implantation procedure is completed, as shown in figure 5 e.

The foregoing description of several embodiments of the application has been presented for purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, construction, and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the following claims.

Claims (10)

1. A precisely adjustable implant device delivery system, comprising: the bending device comprises a control mechanism, a bending pipe fitting, a control wire, a fixing piece and a joint piece, wherein the joint piece is rotatably connected to the far end of the fixing piece, the fixing piece is provided with a guide channel, the near end of the control wire is connected with the control mechanism, the far end of the control wire penetrates through the guide channel and is connected with the joint piece, and the near end of the fixing piece is connected with the far end of the bending pipe fitting, and the bending device is characterized in that: the operating mechanism comprises a rotating adjusting piece, a bending adjusting control piece connected with the rotating adjusting piece and a bending adjusting track matched with the bending adjusting control piece, the proximal end of the operating wire is connected with the rotating adjusting piece, and when the rotating adjusting piece is rotated, the operating wire pulls the connecting piece to rotate circumferentially relative to the fixing piece; when the rotating adjusting piece is fixed and the bending adjusting control piece is pulled, so that the bending adjusting control piece slides along the bending adjusting track, the operating wire pulls the joint piece and drives the bending adjusting pipe piece to bend.

2. The implant device delivery system of claim 1, wherein: the connecting piece is provided with a connecting part, the far end of the control wire is connected with the connecting part, and an included angle is preset between a connecting line formed from the center of the connecting part to the center of the connecting piece and a connecting line formed from the center of the guide channel to the center of the fixing piece.

3. The implant device delivery system of claim 2, wherein: the connecting piece is provided with a first connecting part and a second connecting part, and the first connecting part and the second connecting part are symmetrically arranged on two sides of the guide channel.

4. The implant device delivery system of claim 2, wherein: the guide channel includes a first channel and a second channel, wherein the first channel and the second channel are symmetrically disposed at both sides of the connection point portion.

5. The implant device delivery system of claim 2, wherein: the control wires comprise a first control wire and a second control wire, when the rotating adjusting piece is rotated, the effective stroke of the first control wire or the second control wire is shortened, and the joint piece is driven to rotate circumferentially; when the rotary adjusting piece is fixed and the bending adjusting control piece is pulled to enable the bending adjusting control piece to slide along the bending adjusting track, the effective stroke of the first operating wire and the second operating wire is kept unchanged and the bending adjusting pipe piece is driven to bend.

6. The implant device delivery system of claim 2, wherein: the bending adjusting pipe fitting is provided with a cutting slot for adjusting curvature, and when the rotating adjusting piece is fixed and the bending adjusting control piece is pulled to enable the bending adjusting control piece to slide along the bending adjusting track, the first operating line and the second operating line simultaneously pull the connecting portion to enable the distal end of the bending adjusting pipe fitting to be stressed, and the bending adjusting pipe fitting is bent.

7. The implant device delivery system of claim 5, wherein: the rotating adjusting piece comprises a winding rod and a control knob, and the near ends of the first control wire and the second control wire are respectively connected with the winding rod.

8. The implant device delivery system of claim 7, wherein: the bending adjusting control piece comprises a sliding block connected with the rotating adjusting piece and a locking device arranged on the sliding block, wherein a positioning hole matched with the locking device is formed in the bending adjusting track.

9. The implant device delivery system of claim 8, wherein: the bending adjusting track is provided with bending adjusting marks corresponding to the positioning holes, and when the sliding block is pulled, the locking device slides out of the positioning holes and enters the next positioning hole to achieve locking.

10. The implant device delivery system of claim 9, wherein: the locking device comprises a spring and a ball, the ball is matched with the positioning hole, one end of the spring is fixedly connected with the sliding block, and the other end of the spring is matched and connected with the ball.

Images