CN115708921B

CN115708921B - Handle of conveying system for interventional therapy and conveying system

Info

Publication number: CN115708921B
Application number: CN202310028265.1A
Authority: CN
Inventors: 张垒; 徐军
Original assignee: Suzhou Huihe Medical Technology Co ltd
Current assignee: Suzhou Huihe Medical Technology Co ltd
Priority date: 2023-01-09
Filing date: 2023-01-09
Publication date: 2023-05-12
Anticipated expiration: 2043-01-09
Also published as: CN115708921A

Abstract

The present invention relates to a handle for a delivery system for interventional procedures and a delivery system. The handle comprises a shell, a first sliding block, a first operating piece, a prompt component and the like. The prompting component comprises the first convex part and the second convex part, and when the first sliding block moves to the first convex part and the second convex part to collide, the collision can generate sound and/or vibration on hand feeling so as to prompt an operator that the first sliding block slides to the initial position, and at the moment, the distal end of the sheath tube returns to a straight state, so that X-ray perspective is not required to be used for observing whether the distal end of the sheath tube is aligned. In addition, the handle disclosed by the invention has the advantages of simple structure, reliable voice and/or hand feeling prompt, moderate amplitude and difficult damage to blood vessels.

Description

Handle of conveying system for interventional therapy and conveying system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a handle of a conveying system for interventional therapy and the conveying system.

Background

Heart valve degenerative diseases (including calcification, myxodegeneration, etc.) and metabolic disorder valve damage are also increasing, so the significance of heart valve replacement and repair is very important. The replacement and repair of the common heart valve are usually treated in a surgical mode, but the surgical operation treatment is more traumatic, the postoperative recovery time is longer, and along with the development of interventional medical technology in recent years, the interventional treatment provides a simple and convenient way for the treatment of the heart valve.

In minimally invasive interventional procedures, a delivery system is used to create an extracorporeal to internal (primarily, lesion) delivery channel from which an implant device (e.g., occluder, valve, stent, balloon, vascular plug, filter, etc.) may be delivered to the lesion or retrieved. Through which a drug can also be introduced into the patient or a body fluid can be removed from the patient.

Currently, the interventional operation usually adopts X-ray to assist an operator in knowing the position and state of a sheath in a body, and because of the complex path of a human body blood vessel, especially to a heart valve position, when the interventional operation is used for treating the heart valve, the operation time is usually long, and a patient needs to be exposed to X-rays for a long time. In addition, since the sheath of the current delivery system can be bent in two directions, when the sheath is retracted after the treatment is completed, if the sheath does not return to the initial position where the sheath is not bent, a certain damage is easily caused to the vessel wall during the process of retracting the sheath.

Therefore, there is a need to address how to facilitate the operator to know the status of the distal end of the sheath while minimizing the exposure time of the patient to X-rays.

Disclosure of Invention

The invention aims to provide a handle of a conveying system for interventional therapy and a conveying system, which can enable an operator to know that a sheath tube returns to an initial position through sound and/or hand feeling prompt.

In order to achieve the above purpose, the invention adopts the following technical scheme:

a first aspect of the invention provides a handle for a delivery system for interventional therapy, the handle comprising:

a housing;

the first sliding block is slidably arranged in the shell and can slide along the direction of the far end and the near end, and is used for fixing a first traction wire and a second traction wire, and when the first sliding block slides, the movement directions of the first traction wire and the second traction wire are opposite;

the first operating piece is arranged on the shell and matched with the first sliding block, and when the first operating piece is operated, the first operating piece can drive the first sliding block to slide;

a cue assembly including a first protrusion and a second protrusion; the first convex part is fixedly arranged or formed on the outer surface of the first sliding block and protrudes towards the outer part of the first sliding block; the second convex part is fixedly arranged or formed on the inner surface of the shell and protrudes towards the inside of the shell, and the second convex part is positioned at the middle position of the sliding stroke of the first sliding block; during the sliding process of the first sliding block, when the first convex part slides from one side of the second convex part to the other side, the first convex part and the second convex part collide to generate sound and/or hand feeling prompt.

Preferably, the distance between the top end of the first protrusion and the top end of the second protrusion is 0.325-0.425 mm.

Preferably, the proximal end surface of one of the first protrusion and the second protrusion extends obliquely from the bottom end to the top end in the distal direction, and the distal end surface extends obliquely from the bottom end to the top end in the proximal direction, and the surface of the top end of the other of the first protrusion and the second protrusion is a convex arc surface.

Further preferably, an included angle between the proximal end face and the distal end face is 90-110 °.

According to a specific and preferred embodiment, the handle further comprises a third protrusion fixedly arranged or formed on the inner surface of the housing and protruding towards the inside of the housing, the second protrusion and the third protrusion being arranged at intervals in the proximal distal direction, and during sliding of the first slider, when the first protrusion slides from one side of the third protrusion to the other side, the first protrusion and the third protrusion collide to generate a sound and/or a feel cue.

Further, the second convex portion and the third convex portion are identical in shape and size.

Further, when the first convex portion is located between the second convex portion and the third convex portion, the first convex portion is in contact with the second convex portion and the third convex portion, respectively.

Further, when the first protrusion is in contact with the second protrusion and the third protrusion, respectively, the handle is at the initial position, and the distal end of the sheath tube is in an unbent linear state.

Further, the distance between the center of the second convex part and the center of the third convex part is 2.4-2.8 mm.

According to another specific and preferred embodiment, the handle further comprises a third protrusion fixedly arranged or formed on the outer surface of the first slider and protruding towards the outside of the first slider, the first protrusion and the third protrusion being arranged at intervals in the proximal distal direction, and during sliding of the first slider, when the third protrusion slides from one side of the second protrusion to the other side, the third protrusion collides with the second protrusion to generate a sound and/or a feel cue.

Further, the first protrusion and the third protrusion are identical in shape and size.

Further, when the second convex portion is located between the first convex portion and the third convex portion, the second convex portion is in contact with the first convex portion and the third convex portion, respectively.

Further, when the second protrusion contacts the first protrusion and the third protrusion, respectively, the handle is at the initial position, and the distal end of the sheath tube is in an unbent linear state.

Further, the distance between the center of the first protruding portion and the center of the third protruding portion is 2.4-2.8 mm.

According to some specific and preferred embodiments, the cue assembly comprises two sets symmetrically disposed along the axis of the first slider.

According to some specific and preferred embodiments, the handle further comprises a rotating shaft which is installed in the shell and can rotate around the axis of the handle, the rotating shaft is located at the proximal end of the first sliding block, the proximal end of the first traction wire is directly fixedly connected with the first sliding block, and the second traction wire bypasses the rotating shaft and is fixedly connected with the first sliding block.

According to some specific and preferred embodiments, the first traction wire and the second traction wire are respectively fixed on opposite sides of the first slider by locking means.

According to some specific and preferred embodiments, first sliding grooves are formed on opposite sides of the housing, first external threads protruding out of the first sliding grooves are formed on opposite sides of the first sliding block, and first internal threads capable of being matched with the first external threads are formed on an inner surface of the first operating member.

According to some specific and preferred embodiments, the first slider, the first operating member and the prompting assembly are one set, or a plurality of sets arranged in a proximal-distal direction.

According to some specific and preferred embodiments, the handle further comprises a second slider slidably mounted within the housing and capable of sliding in a distal proximal direction, a second operating member mounted on the housing and cooperating with the second slider, the second slider being for securing a third traction wire.

Further, the second slider is located at a proximal end of the first slider.

Further, the second traction wire and the third traction wire are located on the same side.

Further, the third traction wire is fixed on the second sliding block through a locking device.

Further, second sliding grooves are formed on two opposite sides of the shell respectively, second external threads extending out of the second sliding grooves are formed on two opposite sides of the second sliding block, and second internal threads capable of being matched with the second external threads are formed on the inner surface of the second operating piece.

According to some specific and preferred embodiments, the material of the housing, the first slider and the prompt component is plastic.

A second aspect of the present invention provides a delivery system for interventional therapy, the delivery system comprising the above-described handle, the delivery system further comprising a sheath having an inner lumen, a first anchor ring fixedly mounted at a distal end of the sheath, the first traction wire and the second traction wire having distal ends fixedly connected to opposite sides of the first anchor ring, respectively, the handle being sleeved at a proximal end of the sheath.

Further, the delivery system further comprises a second anchoring ring fixedly mounted on the sheath and positioned at the proximal end of the first anchoring ring, and a third traction wire with the distal end fixedly connected with the second anchoring ring.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

according to the invention, the prompting component is arranged, when the first sliding block moves to the first convex part and the second convex part to collide, the collision can generate sound and/or vibration on hand feeling so as to prompt an operator that the first sliding block slides to the initial position, and at the moment, the distal end of the sheath tube returns to a straight line state, so that the X-ray perspective is not required to observe whether the distal end of the sheath tube returns to the normal state. In addition, the handle has the advantages of simple structure, reliable voice and/or hand feeling prompt and moderate amplitude, and is not easy to damage blood vessels.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the description of the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a perspective view of a delivery system of an embodiment (the distal end of the sheath being in an initial state and forming a forward or reverse "C" bend, respectively);

FIG. 2 is a perspective view of a delivery system of an embodiment (the distal end of the sheath being in an initial state and forming an "S" bend, respectively);

FIG. 3 is an exploded view of a handle of an embodiment;

FIG. 4 is a first longitudinal cross-sectional view of a handle of an embodiment;

FIG. 5 is a schematic view of a shaft according to one embodiment;

FIG. 6 is a schematic view of a shaft of another embodiment;

FIG. 7 is a schematic view of a shaft of yet another embodiment;

FIG. 8 is a second longitudinal cross-sectional view of the handle of the embodiment;

FIG. 9 is an enlarged view of a portion of FIG. 8;

FIG. 10 is a schematic view of the mating of the housing and the first slider;

FIG. 11 is a perspective view of the locking device mated with the first slider;

FIG. 12 is a schematic view of the sliding directions of the first slider and the second slider on the housing;

wherein, 1, sheath tube; 2. a first traction wire; 3. a second traction wire; 4. a third traction wire; 5. a distal cap; 6. a housing; 61. an upper housing; 62. a lower housing; 63. a first chute; 64. a second chute; 7. a first slider; 71. a first external thread; 72. a second wire hole; 73. a first mounting groove; 8. a first operating member; 9. a second slider; 91. a second external thread; 92. a third wire hole; 93. a third mounting groove; 10. a second operating member; 11. a tailstock; 12. a proximal cap; 13. a through hole; 14. a locking device; 15. a rotating shaft; 16. a first convex portion; 17. a second convex portion; 18. and a third protrusion.

Detailed Description

Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

In the description of the present application, it is to be understood that distal refers to the end of the instrument or component that is distal to the operator, and proximal refers to the end of the instrument or component that is proximal to the operator; axial refers to a direction parallel to the central line of the distal and proximal ends of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential or circumferential refers to a direction around the axial direction; the inner and outer are positions defined relative to the distance of the center of the instrument or component, wherein the inner is a position near the center of the instrument or component and the outer is a position away from the center of the instrument or component. The above description of orientation words is merely for convenience in describing embodiments of the present invention and for simplicity of description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting embodiments of the present invention.

In the following, terms proximal, distal, up, down, front, back, etc. are described in terms of the orientation of fig. 1, wherein the side of the sheath is distal, the side of the handle is proximal, the upper side of fig. 1 is up, the lower side is down, the side closer to the viewer is front, and the side farther from the viewer is back.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless explicitly defined otherwise.

In this application, unless specifically stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the embodiments of the present invention will be understood by those of ordinary skill in the art according to specific circumstances.

The following disclosure provides many different implementations, or examples, for implementing different configurations of embodiments of the invention. In order to simplify the disclosure of embodiments of the present invention, components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present invention. Furthermore, embodiments of the present invention may repeat reference numerals and/or letters in the various examples, which are for the purpose of brevity and clarity, and which do not themselves indicate the relationship between the various embodiments and/or arrangements discussed.

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

Fig. 1 and 2 show a delivery system for interventional procedures comprising a sheath 1 having a lumen, a first anchoring ring, a second anchoring ring, a first pull wire 2, a second pull wire 3, a third pull wire 4, and a handle mounted at the proximal end of the sheath 1.

Wherein the first and second anchoring rings are fixedly mounted at the distal end of the sheath 1 and the second anchoring ring is located at the proximal end of the first anchoring ring, respectively. Specifically, the sheath 1 includes a main body section located at a proximal end, a first bending control section located at a distal end, and a second bending control section located between the main body section and the first bending control section, wherein the first anchoring ring is mounted at the distal end of the first bending control section, and the second anchoring ring is mounted at the distal end of the second bending control section. The distal ends of the first and

second traction wires

2, 3 are fixed to opposite sides of the first anchor ring, respectively, in this embodiment to the upper and lower sides of the first anchor ring, respectively. The distal end of the third traction wire 4 is fixed on the second anchoring ring, wherein the connection point of the third traction wire 4 and the second anchoring ring can be set arbitrarily according to the requirement. In this embodiment, the third traction wire 4 is fixed to the lower side of the second anchor ring, and a straight line formed by the connection point of the second traction wire 3 and the first anchor ring and the connection point of the third traction wire 4 and the second anchor ring is parallel to the axis of the sheath tube 1 in the initial state. The connection mode of the anchoring ring and the traction wire, the specific structure of the sheath tube 1 and the specific structure of the traction wire penetrating through the sheath tube 1 are not important points of improvement in the application, so long as the structure that the distal end of the sheath tube 1 presents different bending shapes through the adjusting handle can be realized, for example, refer to patent CN115300752A.

As shown in fig. 3 to 12, the handle includes a distal cap 5, a housing 6, a first slider 7, a first operating element 8, a second slider 9, a second operating element 10, a cue assembly, a tailstock 11, a proximal cap 12, and the like. In this application, the material of casing 6, first slider 7, second slider 9 and suggestion subassembly is plastics, and the material of other parts can be plastics, also can be the metal material.

As shown in fig. 3 and 4, through holes 13 through which the sheath tube 1 passes are formed in the first slider 7 and the second slider 9, respectively, and the proximal end portion of the sheath tube 1 sequentially passes through the distal end cap 5, the first slider 7, and the second slider 9, respectively, and is fixedly mounted on the tailstock 11, wherein the sheath tube 1 and the tailstock 11 can be fixedly connected by means of bonding or the like. The housing 6 includes detachably connected upper and

lower housings

61 and 62, the upper and

lower housings

61 and 62 are respectively sleeved outside the first and

second sliders

7 and 9, and the first and

second sliders

7 and 9 can slide in a space enclosed by the upper and

lower housings

61 and 62. The distal ends of the upper and

lower cases

61 and 62 and the distal end cap 5 are screw-coupled, the proximal ends of the upper and

lower cases

61 and 62 are sleeved outside the tailstock 11, and the proximal ends of the upper and

lower cases

61 and 62 and the proximal end cap 12 are screw-coupled, thereby realizing a handle sleeve mounted on the proximal end of the sheath tube 1.

Specifically, the housing 6 is symmetrically formed with a first slide groove 63 and a second slide groove 64 on opposite sides thereof, respectively. As shown in fig. 3, specifically, the upper housing 61 is formed with a first chute 63 and a second chute 64, respectively, the second chute 64 is located at a proximal end of the first chute 63, and the first chute 63 and the second chute 64 extend in distal and proximal directions, respectively; the lower housing 62 is also formed with a first runner 63 and a second runner 64, respectively, the second runner 64 being located proximal to the first runner 63, the first runner 63 and the second runner 64 extending in distal and proximal directions, respectively.

As shown in fig. 3, 4 and 10 to 12, first external threads 71 extending out of the first sliding groove 63 are formed on opposite sides of the first sliding block 7, specifically, first external threads 71 are formed on an upper side of the first sliding block 7, first external threads 71 are formed on a lower side of the first sliding block 7, the first external threads 71 on the upper side are located at a distal end of the first sliding block 7, the first external threads 71 on the lower side are located at a proximal end of the first sliding block 7, and thus the first external threads 71 on the upper side and the lower side are staggered in a circumferential direction, and further stability of sliding of the first sliding block 7 driven by the first operating member 8 is improved.

The first operating member 8 is mounted on the housing 6 and is rotatable about its own axis, and a first female screw capable of being engaged with the first male screw 71 is formed on an inner surface of the first operating member 8, so that when an operator rotates the first operating member 8, the first slider 7 slides in a proximal-distal direction along with the rotation of the first operating member 8 under the engagement of the first female screw and the first male screw 71 and the restriction of the first chute 63, specifically, when the first operating member 8 is rotated in the forward direction, the first slider 7 slides in the proximal direction; when the first operating member 8 is rotated in the opposite direction, the first slider 7 slides in the distal direction.

Wherein, the upper side of the first slider 7 is formed with a first threading hole penetrated along the proximal distal direction for the first traction wire 2 to pass through, and the lower side of the first slider 7 is formed with a second threading hole 72 penetrated along the proximal distal direction for the second traction wire 3 to pass through. A first mounting groove 73 communicating with the first wire passing hole is formed on the upper surface of the first slider 7, and a second mounting groove communicating with the second wire passing hole 72 is formed on the lower surface of the first slider 7.

A locking device 14 is fixedly arranged in each of the first mounting groove 73 and the second mounting groove. The first drawing wire 2 passes through the first wire-passing hole and extends into the locking device 14, and the locking device 14 is used for fixedly connecting the proximal end of the first drawing wire 2 with the first sliding block 7.

As shown in fig. 4, the handle further includes a rotating shaft 15 mounted in the housing 6 and capable of rotating about its own axis, the rotating shaft 15 being located at the proximal end of the first slider 7. The second traction wire 3 passes through and extends out of the second wire penetrating hole 72, bypasses the rotating shaft 15, then passes back into the second wire penetrating hole 72 and extends into the locking device 14, and the locking device 14 is used for realizing the fixed connection of the second traction wire 3 and the first sliding block 7.

The second traction wire 3 can be wound around the rotating shaft 15 capable of rotating around the axis of the second traction wire, so that the first traction wire 2 and the second traction wire 3 can realize reverse motion along with the sliding of the first sliding block 7, static friction is always generated between the second traction wire 3 and the rotating shaft 15 in the moving process of the second traction wire 3, and the failure of the sheath tube 1 bending control function due to the breakage of the second traction wire 3 can be well avoided. If sliding friction is adopted between the traction wire and the rotating shaft 15, the materials are required to be deoiled and cleaned in the field of medical equipment, so that the friction force between the traction wire and the fixed shaft is very large, and in the bending adjustment process, the traction wire is easily broken to cause the bending failure of the sheath tube 1.

In this application, the rotating shaft 15 may have various structures, so long as the rotating shaft 15 can rotate around its own axis under the driving of the traction wire when the traction wire moves, for example, the rotating shaft may be a metal shaft shown in fig. 5, a bearing shown in fig. 6, a shaft sleeve shown in fig. 7, and the like.

The particular construction of the locking device 14 is not critical to the improvement of the present application, and for example, the locking device of CN113349845a may be used.

As shown in fig. 12, when the distal end of the sheath tube 1 is not bent, i.e., the distal end of the sheath tube 1 is in a straight line, the first slider 7 is at an initial position, and at this time, by rotating the knob forward or backward, the first slider 7 can be driven to slide toward the proximal end or the distal end, so as to drive the first traction wire 2 and the second traction wire 3 to move backward (i.e., when the first traction wire 2 is tightened, the second traction wire 3 is loosened, and when the first traction wire 2 is loosened, the second traction wire 3 is tightened), so as to drive the distal end of the sheath tube 1 to form a forward or backward "C" bend as shown in fig. 1. The structure of the present application can well protect the sheath tube 1 and the traction wire.

As shown in fig. 3 and 8 to 11, in order to facilitate the operator to know whether the distal end of the sheath tube 1 returns to the original position in the straight state, a prompt component is provided in the present application. Preferably, the prompting component comprises two groups symmetrically arranged along the axial lead of the first sliding block 7, in particular symmetrically arranged along the front side and the rear side of the first sliding block 7, so that the feedback of sound and/or hand feeling can be further improved while the damage to the blood vessel wall is avoided as much as possible, and the symmetrical arrangement structure is beneficial to the sliding stability of the first sliding block 7. The cue assembly includes a first protrusion 16, a second protrusion 17, and a third protrusion 18.

According to the first embodiment, as shown in fig. 3 and 8 to 11, the first protrusion 16 is fixedly provided or formed on the outer surfaces of the front and rear sides of the first slider 7 and protrudes toward the outside of the first slider 7, wherein the first protrusion 16 may be integrally formed with the first slider 7 by injection molding or the like, or may be fixedly connected to the first slider 7 by bonding or the like. The second protrusions 17 are fixedly disposed or formed on inner surfaces of front and rear sides of the housing 6 and protrude toward the inside of the housing 6, and the third protrusions 18 are fixedly disposed or formed on inner surfaces of front and rear sides of the housing 6 and protrude toward the inside of the housing 6, and the second protrusions 17 and the third protrusions 18 may be integrally formed with the housing 6 by injection molding or the like, or may be fixedly connected to the housing 6 by bonding or the like. The second protrusion 17 and the third protrusion 18 are disposed at intervals in the proximal-distal direction, and the second protrusion 17 and the third protrusion 18 are located at intermediate positions of the sliding stroke of the first slider 7, that is, approximately near the midpoint of the length of the first slide groove 63.

When the handle is in the initial position (i.e. the distal end of the sheath 1 is not bent), the first protrusion 16 is located between the second protrusion 17 and the third protrusion 18, and the first protrusion 16 is in contact with the second protrusion 17 and the third protrusion 18, respectively.

When the first operating member 8 is rotated to slide the first slider 7, the first slider 7 slides to slide the first protrusion 16 out from between the second protrusion 17 and the third protrusion 18. When the first operating member 8 rotates reversely to drive the first slider 7 to slide reversely, the first slider 7 slides to enable the first protrusion 16 to collide with the second protrusion 17 or the third protrusion 18 and slide from one side of the second protrusion 17 or the third protrusion 18 to the other side, the prompting device generates sound and/or hand feeling prompts, when an operator hears the sound and/or perceives vibration of the handle, the operator knows that the distal end of the sheath tube 1 is corrected, at this time, the operator stops rotating the knob, and the first protrusion 16 is clamped between the second protrusion 17 and the third protrusion 18, so that the patient does not need to be exposed to X-ray perspective.

As shown in fig. 9, the second convex portion 17 and the third convex portion 18 have the same shape and size, and the surfaces of the tips of the second convex portion 17 and the third convex portion 18 are convex arc surfaces, preferably semi-cylindrical surfaces. The proximal end surface of the first protruding portion 16 extends obliquely from the bottom end to the top end toward the distal end direction, the distal end surface extends obliquely from the bottom end to the top end toward the proximal end direction, the distal end surface of the first protruding portion 16 is a plane extending in the proximal distal end direction, and the distal end surface of the first protruding portion 16 and the proximal end surface and the distal end surface are in arc transition. Here, the bottom end of the protrusion means the end of the protrusion connected to the housing 6 or the slider, and the top end is the end of the protrusion away from the housing 6 or the slider.

Further, the distance d1 between the tip of the first protrusion 16 and the tip of the second protrusion 17 is 0.325 to 0.425mm, preferably 0.35 to 0.40mm, more preferably 0.36 to 0.39mm, and even more preferably 0.37 to 0.38mm. The angle α between the proximal surface and the distal surface of the first projection 16 is 90 to 110 °, preferably 95 to 105 °, and more preferably 98 to 102 °. The distance d2 between the center of the second convex portion 17 and the center of the third convex portion 18 is 2.4 to 2.8mm, preferably 2.5 to 2.7mm.

The interference fit between the convex parts is used for prompting the assembly, and the convex parts are optimized through the size and the structure of the convex parts, so that the device has the advantages of simple structure, and the problems of blocking and the like are not easy to occur in the movement process.

According to a second embodiment, not illustrated, this embodiment is substantially identical to the first embodiment, except for the following:

the first convex portion 16 is fixedly provided or formed on the outer surfaces of the front and rear sides of the first slider 7 and projects toward the outside of the first slider 7, and the third convex portion 18 is fixedly provided or formed on the outer surface of the first slider 7 and projects toward the outside of the first slider 7, the first convex portion 16 and the third convex portion 18 being disposed at intervals in the proximal-distal direction. The first convex portion 16 and the third convex portion 18 have the same shape and size, and the distance between the center of the first convex portion 16 and the center of the third convex portion 18 is 2.4 to 2.8mm, preferably 2.5 to 2.7mm. The second protrusions 17 are fixedly provided or formed on inner surfaces of front and rear sides of the housing 6 and protrude toward the inside of the housing 6. The second protrusion 17 is located at a middle position of the sliding stroke of the first slider 7, that is, approximately at the midpoint of the length of the first chute 63.

When the handle is in the initial position (i.e. the distal end of the sheath 1 is not bent), the second protrusion 17 is located between the first protrusion 16 and the third protrusion 18, and the second protrusion 17 is in contact with the first protrusion 16 and the third protrusion 18, respectively.

When the first operating member 8 is rotated to slide the first slider 7, the first slider 7 slides to slide the first protrusion 16 or the third protrusion 18 over the second protrusion 17. When the first operating member 8 is rotated reversely to drive the first slider 7 to slide reversely, the first slider 7 slides to enable the third protrusion 18 or the first protrusion 16 to collide with the second protrusion 17 and slide from one side of the second protrusion 17 to the other side, the prompting device generates sound and/or hand feeling prompts, when the operator hears the sound and/or perceives the vibration of the handle, the operator knows that the distal end of the sheath tube 1 is corrected, at this time, the operator stops rotating the knob, and the second protrusion 17 is clamped between the first protrusion 16 and the third protrusion 18.

The features of the first, second and

third protrusions

16, 17 and 18 of the presentation component of this embodiment, such as the shape and size, are the same as those of the first embodiment described above, and will not be described again here.

According to still another embodiment, not shown, the shapes of the first convex portion 16 and the second convex portion 17 may be changed in the first embodiment and the second embodiment, that is, the surface of the distal end of the first convex portion 16 may be a convex arc surface, the proximal end surface of the second convex portion 17 may extend obliquely from the bottom end to the distal end direction, the distal end surface of the first convex portion 16 may be a plane extending in the proximal distal end direction, and the distal end surface of the first convex portion 16 may transition from the proximal end surface to the distal end surface through an arc.

In this application, the first slider 7, the first operating element 8 and the prompting element may be a set as shown in fig. 1 to 12, or may be formed into more complex space curves according to actual needs, for example, according to the distal end of the sheath 1, etc., and the first slider 7, the first operating element 8 and the prompting element are arranged into a plurality of sets along the proximal-distal direction.

As shown in fig. 1 to 4 and 5, the second external threads 91 protruding out of the second sliding groove 64 are formed on opposite sides of the second sliding block 9, specifically, the second external threads 91 are formed on the upper side of the second sliding block 9, the second external threads 91 are formed on the lower side of the second sliding block 9, the second external threads 91 on the upper side are located at the proximal end of the second sliding block 9, the second external threads 91 on the lower side are located at the distal end of the second sliding block 9, and thus the second external threads 91 on the upper side and the lower side are staggered in the circumferential direction, and further, the sliding stability of the second sliding block 9 driven by the second operating member 10 is improved.

The second operating member 10 is mounted on the housing 6 so as to be rotatable about its own axis, and a second female screw is formed on an inner surface of the second operating member 10 so as to be engageable with the second male screw 91, so that when the operator rotates the second operating member 10, the second slider 9 slides in the proximal-distal direction with the rotation of the second operating member 10 under the engagement of the second female screw and the second male screw 91 and the restriction of the second slide groove 64.

Wherein, a third threading hole 92 penetrating along the proximal and distal direction is formed on the upper side and/or the lower side of the second slider 9, and a third mounting groove 93 communicating with the third threading hole 92 is formed on the surface of the second slider 9 on the side of the third threading hole 92. A locking device 14 is fixedly arranged in the third mounting groove 93.

When a traction wire is fixed on the second slide 9, the third traction wire 4 passes through the third wire through hole 92 and extends into the locking device 14, and the proximal end of the third traction wire 4 is fixedly connected with the second slide 9 through the locking device 14. When two traction wires are fixed to the second slider 9, the two traction wires can be installed in the same manner as the first traction wire 2 and the second traction wire 3 described above.

As shown in fig. 3 and 4, the second slider 9 is located at the proximal end of the first slider 7, and the second drawing wire 3 and the third drawing wire 4 are located on the same side, i.e. the third drawing wire 4 passes through a third wire through hole 92 located at the lower side of the second slider 9 and protrudes into the locking device 14 for fixation.

When the first operating member 8 is rotated in the forward direction to bend the first bending control section of the sheath 1 in the forward direction "C" as shown in FIG. 1, the distal end of the sheath 1 is bent in the "S" shape as shown in FIG. 2 by rotating the second operating member 10.

According to the sheath tube 1, through the improvement of the structure, the bending of the distal end of the sheath tube 1 can be regulated and controlled in a segmented manner through the operation piece on the control handle, so that the distal end of the sheath tube 1 is bent in a positive direction ' C ' and in a reverse direction ' C ', or the distal end of the sheath tube 1 is bent in an S ' manner through two-segment comprehensive regulation and control; in addition, the sliding block can bear larger pulling force, the first operating piece 8 and the second operating piece 10 do not need to apply larger torque, the transmission efficiency between the operating piece and the sliding block is high, and the operation experience is strong; in addition, the handle of the surgical operation device is simple in structure, small in size, simple to assemble, very stable in the surgical operation process, and difficult to cause the problems of traction wire breakage and the like.

According to the invention, by arranging the prompting component, when the first sliding block 7 moves to the first convex part 16 and the second convex part 17 to collide, sound and/or vibration on hand feeling can be generated when the collision occurs, so that an operator is prompted that the first sliding block 7 is slid to the initial position, and at the moment, the distal end of the sheath tube 1 returns to the straight state, and therefore, whether the distal end of the sheath tube 1 is aligned or not is not observed by X-ray perspective. In addition, the handle is simple in structure, reliable in sound and/or hand feeling prompt and moderate in amplitude, and is not easy to damage blood vessels.

The above embodiments are provided to illustrate the technical concept and features of the present invention and are intended to enable those skilled in the art to understand the content of the present invention and implement the same, and are not intended to limit the scope of the present invention. Equivalent changes are made according to the spirit of the invention.

Claims

1. A handle for a delivery system for interventional procedures, comprising: the handle includes:

a housing (6), the housing (6) comprising an upper housing (61) and a lower housing (62) detachably connected;

a first slider (7), the first slider (7) being slidably mounted within the housing (6) and being capable of sliding in a distal proximal direction, the first slider (7) being adapted to fix a first traction wire (2) and a second traction wire (3), the movement directions of the first traction wire (2) and the second traction wire (3) being opposite when the first slider (7) is slid; the first traction wire (2) and the second traction wire (3) are respectively fixed on two opposite sides of the first sliding block (7) through locking devices (14);

the first operating piece (8), the said first operating piece (8) is installed on said body (6) and cooperated with said first slide block (7), when operating the said first operating piece (8), the said first operating piece (8) can drive the said first slide block (7) to slide; the upper shell (61) and the lower shell (62) are respectively provided with a first sliding groove (63), the upper side and the lower side of the first sliding block (7) are respectively provided with first external threads (71) extending out of the first sliding groove (63), and the inner surface of the first operating piece (8) is provided with first internal threads which can be matched with the first external threads (71);

a cue assembly comprising a first protrusion (16) and a second protrusion (17); the first convex parts (16) are fixedly arranged or formed on the outer surfaces of the front side and the rear side of the first sliding block (7) and protrude towards the outer part of the first sliding block (7); the second convex part (17) is fixedly arranged or formed on the inner surface of the shell (6) and protrudes towards the inside of the shell (6), and the second convex part (17) is positioned at the middle position of the sliding stroke of the first sliding block (7); during the sliding process of the first sliding block (7), when the first convex part (16) slides from one side of the second convex part (17) to the other side, the first convex part (16) and the second convex part (17) collide to generate sound and/or hand feeling prompt;

the distance between the top end of the first convex part (16) and the top end of the second convex part (17) is 0.325-0.425 mm;

the proximal end surface of one of the first convex part (16) and the second convex part (17) extends obliquely from the bottom end to the top end towards the distal end direction, the distal end surface extends obliquely from the bottom end to the top end towards the proximal end direction, and the surface of the top end of the other one of the two convex parts is a convex cambered surface;

the included angle between the proximal end face and the distal end face is 90-110 degrees;

the handle further comprises a third protrusion (18),

the third convex part (18) is fixedly arranged or formed on the inner surface of the shell (6) and protrudes towards the inside of the shell (6), the second convex part (17) and the third convex part (18) are arranged at intervals in the proximal and distal directions, and during the sliding process of the first sliding block (7), when the first convex part (16) slides from one side to the other side of the third convex part (18), the first convex part (16) and the third convex part (18) collide to generate sound and/or hand feeling prompt; or,

the third convex part (18) is fixedly arranged or formed on the outer surface of the first sliding block (7) and protrudes towards the outer part of the first sliding block (7), the first convex part (16) and the third convex part (18) are arranged at intervals in the proximal end and the distal end directions, and when the third convex part (18) slides from one side to the other side of the second convex part (17) in the sliding process of the first sliding block (7), the third convex part (18) and the second convex part (17) collide to generate sound and/or hand feeling prompt;

when the third convex part (18) is positioned on the shell (6), the distance between the center of the second convex part (17) and the center of the third convex part (18) is 2.4-2.8 mm; or,

when the third convex part (18) is positioned on the first sliding block (7), the distance between the center of the first convex part (16) and the center of the third convex part (18) is 2.4-2.8 mm.

2. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: -the second (17) and third (18) protrusions are identical in shape and size when the third protrusion (18) is located on the housing (6); or,

when the third protrusion (18) is located on the first slider (7), the first protrusion (16) and the third protrusion (18) are identical in shape and size.

3. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: when the third protrusion (18) is located on the housing (6), the first protrusion (16) is located between the second protrusion (17) and the third protrusion (18), the first protrusion (16) being in contact with the second protrusion (17) and the third protrusion (18), respectively; or,

when the third convex part (18) is positioned on the first sliding block (7), the second convex part (17) is positioned between the first convex part (16) and the third convex part (18), and the second convex part (17) is respectively contacted with the first convex part (16) and the third convex part (18).

4. A handle of a delivery system for interventional procedures as set forth in claim 3, wherein: when the third protrusion (18) is located on the housing (6) and the first protrusion (16) is in contact with the second protrusion (17) and the third protrusion (18), respectively, the handle is in an initial position; or,

when the third convex part (18) is positioned on the first sliding block (7) and the second convex part (17) is respectively contacted with the first convex part (16) and the third convex part (18), the handle is in an initial position.

5. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: the prompting component comprises two groups which are symmetrically arranged along the axial lead of the first sliding block (7).

6. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: the handle further comprises a rotating shaft (15) which is arranged in the shell (6) and can rotate around the axis of the handle, the rotating shaft (15) is positioned at the proximal end of the first sliding block (7), the proximal end of the first traction wire (2) is directly fixedly connected with the first sliding block (7), and the second traction wire (3) bypasses the rotating shaft (15) and is fixedly connected with the first sliding block (7).

7. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: the first sliding block (7), the first operating piece (8) and the prompting component are one group or a plurality of groups arranged along the direction of the proximal end and the distal end.

8. The handle of a delivery system for interventional procedures as set forth in claim 1, wherein: the handle further comprises a second slider (9) which is slidably mounted in the housing (6) and can slide along the distal end and the proximal end direction, and a second operating member (10) which is mounted on the housing (6) and is matched with the second slider (9), wherein the second slider (9) is used for fixing the third traction wire (4).

9. The handle of a delivery system for interventional procedures as set forth in claim 8, wherein: the second slider (9) is positioned at the proximal end of the first slider (7); and/or the number of the groups of groups,

the second traction wire (3) and the third traction wire (4) are positioned on the same side; and/or the number of the groups of groups,

the third traction wire (4) is fixed on the second sliding block (9) through a locking device (14); and/or the number of the groups of groups,

second sliding grooves (64) are respectively formed on two opposite sides of the shell (6), second external threads (91) extending out of the second sliding grooves (64) are formed on two opposite sides of the second sliding block (9), and second internal threads capable of being matched with the second external threads (91) are formed on the inner surface of the second operating piece (10).

10. A delivery system for interventional procedures, characterized by: the delivery system comprises the handle as claimed in any one of claims 1 to 9, and further comprises a sheath tube (1) with an inner cavity, a first anchoring ring fixedly arranged at the distal end of the sheath tube (1), and the first traction wire (2) and the second traction wire (3) of which the distal ends are fixedly connected with two opposite sides of the first anchoring ring respectively, wherein the handle is sleeved at the proximal end of the sheath tube (1).

11. The delivery system for interventional therapy of claim 10, wherein: the delivery system further comprises a second anchoring ring fixedly mounted on the sheath tube (1) and positioned at the proximal end of the first anchoring ring, and a third traction wire (4) with the distal end fixedly connected with the second anchoring ring.