CN215688789U - Device for controlling release of implantation instrument - Google Patents

Abstract

The present application relates to the field of medical devices, and in particular to a device for controlling the release of an implantation device, comprising: the device comprises an implantation instrument, a release device and a delivery catheter, wherein the release device is connected with the delivery catheter; the release device comprises a connecting unit, a control piece, a rebound device and a release piece; the proximal end of the implantation instrument penetrates through the connecting unit, one end of the release piece penetrates through the implantation instrument to form detachable connection, and the other end of the release piece is connected with the rebounding device; the rebounding device is connected with the control piece; when the implantation instrument is released, the control piece is pulled to enable the rebounding device to elastically deform under the pulling of the control piece and move towards the proximal end, the rebounding device simultaneously drives the release piece to move towards the proximal end, and the release piece is gradually separated from the implantation instrument to complete the release of the implantation instrument.

Description

Device for controlling release of implantation instrument

Technical Field

The present application relates to the field of medical devices, and more particularly, to a device for controlling the release of an implanted device.

Background

Aortic stenosis is mainly caused by sequelae of rheumatic fever, congenital abnormalities of aortic valve structure or senile calcification of aortic valve. Patients are asymptomatic during the compensation period, and patients with severe aortic stenosis are often accompanied by symptoms of lassitude, dyspnea (exertional or paroxysmal), angina pectoris, vertigo or syncope, and even sudden death.

The aortic valve is opened when the ventricle contracts, the blood in the left ventricle enters the aorta and is emitted to the whole body, the aortic valve is closed when the ventricle relaxes, the blood in the aorta is prevented from flowing back to the left ventricle, and if the aortic valve is not closed completely, the aortic valve cannot be closed tightly in the diastole, so that the blood reversely flows into the left ventricle from the aorta.

In the treatment of aortic valve disease, surgical valve replacement is the traditional effective treatment. However, patients with such diseases are many elderly patients, suffer from multiple organ diseases, are difficult to be subjected to surgical operation, and become patients who are not expected to be clinically treated. In addition, the etiology of degenerative aortic valvular disease is still unclear, and the etiology cannot be treated, and no effective method for inhibiting the development of degenerative aortic valvular disease exists, so that the curative effect of the medicine is poor. The ideal treatment for aortic valve disorders would improve both the symptoms and longevity of the patient. Percutaneous aortic balloon angioplasty, performed in the early years, has been used to treat aortic stenosis, but either single-center data or multi-center registration data have been found to be ineffective in the long term. Surgical valve replacement remains a major treatment option in the country. In recent years, some scholars at home and abroad carry out basic and clinical researches on percutaneous aortic valve replacement and have achieved breakthrough progress. Provides an effective treatment method for high-risk senile degenerative aortic valve patients needing surgical valve replacement. In 2002, Cribier et al succeeded in Transcatheter Aortic Valve Replacement (TAVR), and more than 5 million TAVR surgeries have been performed worldwide, and studies worldwide have shown: this technique is safe and effective for patients who are unable to undergo surgical valve replacement or who are at high risk of surgical valve replacement. Although most of patients who are subjected to TAVR surgery have high risk, the survival rate of the patients after 30 days is higher than 90%, and the hemodynamic index of the patients after TAVR surgery is obviously improved.

However, the autologous aortic insufficiency is still classified as contraindication of TAVR. The main reason is that stable release after the positioning of the implanted device valve is the most critical technical point in TAVR surgery. The aortic valve has openings for the left and right coronary arteries, and the valve is adjacent to the mitral valve, and if the positioning and releasing are unstable, fatal complications such as ejection of an implant device, coronary blockage or massive mitral regurgitation can occur. The conventional TAVR instrument, whether SAPIEN or CoreValve, is primarily used in patients with severe aortic stenosis and is not suitable for patients with aortic regurgitation. Some conceptual attempts have been made by domestic scholars and engineers to address the problem of unstable release of implanted instruments.

Patent No. cn202022259157.x provides an adjustable positioning valve delivery system, which includes a valve prosthesis, a control handle, an inner tube cooperatively connected with the control handle, and an outer sheath, wherein an adjusting mechanism and a control releasing device are cooperatively connected between the inner tube and the outer sheath, the control handle is cooperatively connected with the adjusting mechanism, one end of the valve prosthesis is cooperatively connected with one end of the adjusting mechanism, the control releasing device limits radial expansion of the other end portion of the valve prosthesis, operates the control handle and drives the adjusting mechanism to rotate, the adjusting mechanism drives the valve prosthesis to rotate, during which, the outer sheath remains stationary, and the control releasing device rotates along with the valve prosthesis and keeps relatively stationary with the valve prosthesis; the technical defects of the scheme are as follows: firstly, the cavity tube is also internally provided with a control wire which passes through a limiting part, so that the near end of the valve prosthesis is detachably connected with the control wire, and the control wire is large in quantity and long in sheath tube length, so that the control wire is respectively arranged in a control wire track for preventing the control wire from being wound together, but the design of the control wire track enlarges the pipe diameter for conveying the sheath tube, so that the sheath tube is difficult to enter, the operation process is influenced, the operation wound is enlarged, and the postoperative recovery of a patient is not facilitated; secondly, consider that the control wire needs to pass through the control wire track, the diameter of control wire designs lessly, and simultaneously, the locating part outwards expands owing to have shape memory nature, and then the control wire receives the pressure of locating part, and the control wire is easily by implanting the apparatus and buckling for take out from the control wire and need very big power, have even can't take out so that release failure's risk.

In conclusion, the release device in the prior art has a complex or unreasonable structural design, and has the problems of difficult sheath tube entry, enlarged surgical wound, failure in controlling the filament to be pulled out and the like.

Disclosure of Invention

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

One of the purposes of the present application is to overcome the deficiencies of the prior art, and to solve the problems of the expansion of the tube diameter of the delivery sheath, the difficulty of entering the sheath, the expansion of the surgical trauma and the like due to the arrangement of the control wire track, and to provide a device for controlling the release of the implantation instrument.

According to an aspect of the present application, there is provided an apparatus for controlling release of an implantation device, comprising: the device comprises an implantation instrument, a release device and a delivery catheter, wherein the release device is connected with the delivery catheter; the release device comprises a connecting unit, a control piece, a rebound device and a release piece; the proximal end of the implantation instrument penetrates through the connecting unit, one end of the release piece penetrates through the implantation instrument to form a detachable connection, and the other end of the release piece is connected with the rebounding device; and the rebounding device is connected with the control member; when the implantation instrument is released, the control piece is pulled to enable the rebounding device to be elastically deformed under the action of the control piece and move towards the proximal end, the rebounding device drives the release piece to move towards the proximal end, and the release piece is gradually separated from the implantation instrument to complete the release of the implantation instrument.

According to an embodiment, the control member is one in number, and the release member is multiple in number, so designed for the purpose of: one control wire is pulled to release the plurality of release members.

According to one embodiment, the release member is a rigid member such that the release member is not bent when it is disconnected from the implantation instrument.

According to one embodiment, the travel of the connection point of the insertion instrument to the release element to the distal end of the release element when pre-assembled is less than the maximum elastic deformation travel of the resilient means.

According to an embodiment, the delivery catheter comprises an inner tube and a control tube, the control tube being connected with the connection unit, the control element being arranged between the inner tube and the control tube; and, the inner tube is disposed within and adjacent to the control tube.

According to an embodiment, the resilient means is in a natural state when pre-assembled, the connection unit provides a distally directed support force to the resilient means when the implantation instrument is released, and the connection unit provides a distally directed support force to the resilient means when the implantation instrument is released.

According to an embodiment, the distal end of the control member is fixed to a distal portion of the rebounding device.

According to an embodiment, the point of connection of the control member to the rebounding device is located at a distal end of the rebounding device or at a midpoint of the rebounding device.

According to one embodiment, the connection unit comprises a base, a connection member and a connection ring, the base having a channel provided therein.

According to an embodiment, the base is connected to the delivery conduit.

According to one embodiment, the connecting member has a shape memory, the connecting member having a tendency to expand outwardly within the delivery catheter, the connecting member being at an angle of between 0 ° and 45 ° to the base centerline in its natural state.

According to an embodiment, the inner tube passes through the channel, the channel inner diameter being greater than or equal to the inner tube outer diameter.

According to one embodiment, the implantation instrument comprises a support which passes through the connection ring and a release hole through which the release member forms a detachable connection.

According to an embodiment, the resilient means further comprises a fixed member and an elastic member, the fixed member being arranged at a distal end of the elastic member; and the release member is fixed to the fixing member.

According to an embodiment, the fixing member comprises a communication member, which is connected with the control member.

According to an embodiment, the communication member is a coil or a through hole.

According to an embodiment, a hole is formed in the middle of the fixing member, and the diameter of the hole is larger than or equal to that of the channel.

According to an embodiment, the inner tube passes through the hole.

According to an embodiment, the resilient member is a compression spring having an inner diameter greater than an outer diameter of the inner tube, the outer diameter of the compression spring being greater than the inner diameter of the channel.

According to an embodiment, the resilient means is sleeved outside the inner tube.

According to an embodiment, the resilient means is arranged between the inner tube and the connection ring.

According to one embodiment, the release member has a diameter of 0.2-0.5mm, and the release member does not bend due to excessive pressure on the release member by the support member.

According to an embodiment, the implantation instrument further comprises a positioning member that enters the valve sinus to secure the implantation instrument.

According to an embodiment, the delivery catheter further comprises a withdrawal sheath for releasing the distal end of the implantation instrument.

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

in the prior patent cn202022259157.x, a limiting member is disposed on the proximal end of the valve prosthesis, the limiting member penetrates out of the hole-shaped structure, and the control wire penetrates through the limiting member, so that the proximal end of the valve prosthesis is detachably connected with the control wire, and the defect of the design is that: on one hand, because the number of the control wires is large, and the length of the sheath tube is long, in order to prevent the control wires from being wound together, the control wires are respectively arranged in the control wire tracks, but the design of the control wire tracks enlarges the pipe diameter of the conveying sheath tube, the sheath tube is difficult to enter, the operation process is influenced, the operation wound is enlarged, and the postoperative recovery of a patient is not facilitated, on the other hand, because the implantation instrument has the shape memory property of outward expansion, the limiting part has the acting force of outward expansion, the control wires are extruded between the porous structure and the limiting part, the diameter of the control wires is limited due to the limited space in the pipe cavity, the control wires can be bent, and the like, the force required for pulling the control wires out is huge or the control wires cannot be pulled out, and the operation of a clinical operation is not facilitated, but the technical scheme of the application avoids the problem that the pipe diameter of the conveying sheath tube is enlarged due to the design of the control wires, and the problem that the control wires are bent due to the excessive pressure caused by the outward expansion of the implantation instrument, the release device of the scheme comprises a connecting unit, a control piece, a rebound device and a release piece, wherein the release piece, the connecting unit and an implantation instrument form detachable connection, one end of the rebound device is propped against, the other end of the rebound device is connected with the release piece, the rebound device can elastically deform, when the control piece is pulled to move towards the near end, the rebound device can simultaneously drive the release piece to move towards the near end, the release piece is gradually separated from the implantation instrument to complete release, in the process of completing release, only one control piece is used, so that a control piece track is not needed to be arranged, the inner tube is adjacent to the control piece, the diameter of a conveying catheter is reduced, surgical wounds are reduced, meanwhile, the release piece is positioned between the inner tube and the connecting member in the conveying catheter, the space between the inner tube and the connecting member is large, the diameter of the release piece can be set to be large, so that only a thin release piece can not be selected due to the limited space, the condition that the release piece is bent by the implantation instrument is avoided, the release piece can be smoothly pulled out, the whole process of disassembling the implantation instrument is labor-saving and efficient, and the device has good clinical significance.

According to one concept of the application, the rebounding device is not deformed during preassembling, the rebounding device and the connecting unit can be connected or not connected, the rebounding device is connected with the control piece, and the control piece cannot move randomly and the rebounding device cannot move randomly, so that the rebounding device is controlled, and the overall stability of the releasing device is high; when the apparatus is implanted in the release, the control drives resilient means and moves towards the near-end, and resilient means drives release and moves towards the near-end, again because release both ends respectively with resilient means with implant the apparatus connection, the length of release is little, so resilient means is even to the power of release transmission, the transmission efficiency of power is high, the release can break away from simultaneously and implant the apparatus, release is effectual, the practicality is strong.

According to an idea of the application, the stroke of the connecting point of the implantation apparatus and the release piece to the far end of the release piece is smaller than the maximum elastic deformation stroke of the rebound device, only if the condition is met, the release piece can be separated, the rebound device is arranged at the near end of the connecting point, the circumferential distance between the connecting member and the inner pipe and the axial distance between the connecting ring and the base are effectively utilized, on the premise of not expanding the pipe diameter of the conveying pipe, the rebound device is utilized to realize the release of the implantation apparatus, and the release function is realized while the space utilization rate is improved.

According to another concept of the present application, embodiments of the present application are able to achieve other advantageous technical effects, not listed one by one, which may be partially described below; and will be expected and understood by those skilled in the art upon reading this 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 by reference to the following description taken in conjunction with the accompanying drawings; and embodiments of the application may be better understood, wherein:

FIG. 1 is a schematic view of the overall structure of the delivery device, the implantation instrument and the delivery catheter of the present invention.

Fig. 2a to 2f are schematic views of the control member, the rebounding device, the releasing member and the release principle of the implanting instrument of the present invention, wherein fig. 2c and 2d, and fig. 2e and 2f are two embodiments.

FIGS. 3 a-3 d are schematic views of the delivery catheter, the layout of the coupling unit and the construction of the implantation instrument of the present invention.

FIGS. 4 a-4 d are schematic views illustrating the release process of the implanting device of the present invention.

The figures in the drawings refer to the following features:

1-release means, 11-connection unit, 111-base, 1111-channel, 112-connection member, 113-connection ring, 12-control means, 13-resilient means, 131-fixation means, 1311-hole, 1312-communication means, 132-elastic means, 14-release means, 2-implantation device, 21-support means, 22-release hole, 23-positioning means, 3-delivery catheter, 31-inner tube, 32-control tube, 33-withdrawal sheath.

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 embodiment may be other embodiments; and can be implemented or performed in a variety of 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 be described in more detail below 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.

Among the prior art, the orbital design of control wire has enlarged the pipe diameter of carrying the sheath pipe, leads to the sheath pipe to get into the difficulty, influences the process of operation, and has enlarged the operation wound, is unfavorable for disease postoperative to recover, simultaneously, because implant apparatus has the shape memory nature of outside expansion, the locating part has outside expanded effort for the control wire is extruded between poroid structure and locating part, and the diameter of control wire is limited because the lumen inner space is limited, and the condition such as buckling can appear in the control wire, leads to taking out the power that the control wire required is huge or can't take out, is unfavorable for clinical operation's operation.

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. 1, there is illustrated an apparatus for controlling the release of an implantation device 2 according to an embodiment of the present application, comprising: the implantation device 2, the release device 1 and the delivery catheter 3, wherein the release device 1 is connected with the delivery catheter 3; the release device 1 comprises a connecting unit 11, a control member 12, a rebound device 13 and a release member 14; the proximal end of the implantation instrument 2 passes through the connecting unit 11, one end of the release part 14 passes through the implantation instrument 2 to form a detachable connection, and the other end is connected with the rebounding device 13; and said rebounding device 13 is connected to said control member 12; when releasing the implantation instrument 2, pulling the control member 12 causes the resilient device 13 to elastically deform and move proximally under the action of the control member 121, the resilient device 13 simultaneously drives the release member 14 to move proximally, and the release member 14 gradually disengages from the implantation instrument 2 to complete the release of the implantation instrument 2.

In the first embodiment, the control member 12 is one, and the release members 14 are six in number, as shown in fig. 2a and 2 b.

In this embodiment, when pre-assembled, the distance from the connection point of the implantation instrument 2 and the release element 14 to the distal end of the release element 14 is less than the maximum elastic deformation distance of the resilient means 13.

In the first embodiment, the delivery catheter 3 includes an inner tube 31, a control tube 32 and a withdrawing sheath 33, the control tube 32 is connected to the connection unit 11, and the control member 12 is disposed between the inner tube 31 and the control tube 32; also, the inner tube 31 is arranged inside the control tube 32 adjacent to the control tube 32, as shown in fig. 2c and 3 a.

In this embodiment, the resilient means 13 is in a natural state when pre-loaded, and the coupling unit 11 provides a support force to the resilient means 13 in a distal direction when releasing the insertion device 2, as shown in fig. 2c and 2 d.

In this first embodiment, the connection point of the control member 12 and the rebounding device 13 is located at the distal end of the rebounding device 13, as shown in fig. 2a and 2 b.

In the first embodiment, the connection unit 11 includes a base 111, a connection member 112 and a connection ring 113, the base 111 has a channel 1111 in the middle, the connection member 112 has shape memory, the connection member 112 has a tendency to expand outwards in the delivery catheter 3, and the connection member 112 is naturally located at 0 ° to 45 ° with respect to the central line of the base 111 as shown in fig. 3b and 3c, which is advantageous in that: the radial expansion force of the implantation device 2 can be effectively buffered, and the stable release of the implantation device 2 is facilitated.

In this embodiment, the base 111 is connected to the delivery catheter 3, the inner tube 31 passes through the channel 1111, and the inner diameter of the channel 1111 is greater than or equal to the outer diameter of the inner tube 31.

In this embodiment, the implanting device 2 comprises a support 21, a releasing hole 22 and a positioning member 23, the support 21 passes through the connecting ring 113, and the releasing member 14 passes through the releasing hole 22 to form a detachable connection, as shown in fig. 2c and 3 d.

In this embodiment, the resilient device 13 includes an elastic member 132 and a fixing member 131, the elastic member 132 is a compression spring, the fixing member 131 is installed at a distal end of the elastic member 132, and the releasing member 14 is fixedly connected to the fixing member 131; also, the inner diameter of the elastic member 132 is larger than the outer diameter of the inner tube 31, and the outer diameter of the elastic member 132 is larger than the inner diameter of the channel 1111.

In the first embodiment, the fixing member 131 includes a communication member 1312, the communication member 1312 is connected to the control member 12, and the communication member 1312 is a coil, as shown in fig. 2 b.

In this embodiment, a hole 1311 is disposed in the middle of the fixing member 131, and the diameter of the hole 1311 is greater than or equal to the diameter of the channel 1111.

In this embodiment, the inner tube 31 passes through the hole 1311, and the resilient means 13 is sleeved outside the inner tube 31.

In the first embodiment, the diameter of the release member 14 is 0.2-0.5mm, and the release member 14 is not bent due to the excessive pressure of the support member 21.

An exemplary release implant device of an apparatus for controlling the release of an implant device 2 according to the first embodiment operates as follows:

1. rotating the control tube 32, the releasing device 11 rotates to drive the positioning element 23 to perform circumferential position adjustment, as shown in fig. 4a and 4 b;

2. operating the withdrawal sheath 33 to release the distal end of the implantation instrument 2, as shown in fig. 4 c;

3. pulling the control member 12, the release member 14 follows the resilient means 13 towards the proximal end, as shown in fig. 2c and 2d, and the implantation instrument 22 is released, as shown in fig. 2d and 4 d.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations 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 (13)

1. An apparatus for controlling release of an implantation instrument, comprising: the device comprises an implantation instrument, a release device and a delivery catheter, wherein the release device is connected with the delivery catheter; the method is characterized in that: the release device comprises a connecting unit, a control piece, a rebound device and a release piece; the proximal end of the implantation instrument penetrates through the connecting unit, one end of the release piece penetrates through the implantation instrument to form a detachable connection, and the other end of the release piece is connected with the rebounding device; and the rebounding device is connected with the control member; when the implantation instrument is released, the control piece is pulled to enable the rebounding device to be elastically deformed under the action of the control piece and move towards the proximal end, the rebounding device drives the release piece to move towards the proximal end, and the release piece is gradually separated from the implantation instrument to complete the release of the implantation instrument.

2. A device for controlling the release of an implantation instrument according to claim 1, wherein: the control piece quantity is one, release piece quantity is many.

3. A device for controlling the release of an implantation instrument according to claim 1, wherein: the release part is a rigid part, so that the release part and the implantation instrument cannot deform when being detached and connected.

4. A device for controlling the release of an implantation instrument according to claim 1, wherein: when preassembling, the stroke from the connecting point of the implantation instrument and the release piece to the far end of the release piece is smaller than the maximum elastic deformation stroke of the rebound device.

5. A device for controlling the release of an implantation instrument according to claim 1, wherein: the conveying conduit comprises an inner tube and a control tube, the control tube is connected with the connecting unit, and the control element is arranged between the inner tube and the control tube; and, the inner tube is disposed within and adjacent to the control tube.

6. A device for controlling the release of an implantation instrument according to claim 1, wherein: when the implantation instrument is released, the connecting unit provides a support force towards the distal direction to the rebounding device.

7. A device for controlling the release of an implantation instrument according to claim 1, wherein: the distal end of the control member is fixed to the distal portion of the rebounding device.

8. An apparatus for controlling the release of an implantation device according to claim 5, wherein: the connecting unit comprises a base, a connecting component and a connecting ring; and a channel is arranged in the middle of the base.

9. An apparatus for controlling the release of an implantation device according to claim 8, wherein: the inner tube passes through the channel, and the inner diameter of the channel is larger than or equal to the outer diameter of the inner tube.

10. An apparatus for controlling the release of an implantation device according to claim 8, wherein: the implantation instrument includes a support passing through the connection ring and a release aperture through which the release member forms a detachable connection.

11. An apparatus for controlling the release of an implantation device according to claim 8, wherein: the rebounding device further comprises a fixing piece and an elastic piece, wherein the fixing piece is arranged at the far end of the elastic piece; and the release member is fixed to the fixing member.

12. A device for controlling the release of an implantation instrument according to claim 11, wherein: the middle of the fixing piece is provided with a hole, and the diameter of the hole is larger than or equal to that of the channel.

13. A device for controlling the release of an implantation instrument according to claim 11, wherein: the elastic piece is a compression spring, the inner diameter of the compression spring is larger than the outer diameter of the inner pipe, and the outer diameter of the compression spring is larger than the inner diameter of the channel.

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