CN115414215A - Adjustable fixing support of human heart implantation instrument and use method - Google Patents

Abstract

The application provides an adjustable fixing support of a human heart implantation apparatus and a using method thereof, belonging to the technical field of human heart implantation medical apparatus. The adjustable fixing support comprises a base part, an adjusting part and a handle fixing seat, wherein a first joint and a second joint are formed at two ends of the connecting rod, the first joint comprises a concave spherical seat, a concave spherical pressing block and a first anchor ear, the concave spherical seat is integrally formed with the connecting rod and is formed at the tail end of the connecting rod, the concave spherical pressing block and the concave spherical seat are separately arranged, a first concave spherical surface is formed on the concave spherical seat, a second concave spherical surface is formed on the concave spherical pressing block, when the concave spherical pressing block is connected with the concave spherical seat, the first concave spherical surface of the concave spherical pressing block and the second concave spherical surface of the concave spherical seat are surrounded to form a cavity with an approximate spherical shape, and acting force is applied to the leg part of the anchor ear, so that the friction force of the concave spherical seat and the concave spherical pressing block on the convex spherical head is increased, and the handle fixing seat is fixed.

Description

Adjustable fixing support of human heart implantation instrument and use method

Technical Field

The invention belongs to the technical field of human heart implantation medical instruments, and particularly relates to an adjustable fixing support of a human heart implantation instrument and a using method thereof.

Background

The tricuspid valve is located at the orifice of the right atrioventricular, and the common onset is tricuspid valve insufficiency, namely, systolic blood flow flows back from the right ventricle to the right atrium, which causes the height of the right atrium to be enlarged, the pressure to be increased and venous blood backflow disorder. Right heart failure is likely to occur due to the compensatory hypertrophy of the load in the right ventricle. Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement and tricuspid valve annulus dilatation, and is clinically common due to the causes of tricuspid regurgitation (left heart failure, pulmonary hypertension and the like), and right heart failure symptoms such as weakness, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated after the tricuspid regurgitation. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but requires surgical treatment when regurgitation is severe. Traditional treatment methods include drug therapy, and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection.

At present, several products for minimally invasive transcatheter treatment of tricuspid valve regurgitation are clinically applied, when minimally invasive transcatheter interventional therapy is carried out, instruments are implanted into a human heart through a catheter, an implant component is conveyed to a target tissue position of the human heart through a conveying system, and then the conveying system controls the implant component to act so as to achieve the purpose of operation. The implant component is delivered to the heart position and the motion control is carried out through the far end of the handle, so the posture adjustment and fixation of the handle of the instrument can influence the stability of the operation. Chinese patent document CN202010747908.4 discloses a supporting device of an interventional medical system, which enables a sliding assembly to guide a sliding rod to move through the meshing of a gear and a rack, and controls the rotation amount of the gear to adjust the movement amount of the sliding assembly, however, since a plurality of components need to be installed on a guide rail during an operation, the components of the guide rail are heavy, thereby bringing specific pressure and adjustment to the adjustment joint of the guide rail, and meanwhile, the bracket has the problems of complex structure, insensitive adjustment, looseness after locking and fixing, and the like. There is a need for a stent for an implantation instrument that is sensitive to adjustment and reliable in fixation.

Disclosure of Invention

Aiming at the defects that the existing human heart implantation instrument is insensitive to adjustment and is easy to loosen after being locked and fixed, the adjustable fixing support of the human heart implantation instrument can be applied to the valvular repair of the heart, and the adjustment and the fixation of any posture of the handle of the implantation instrument can be realized through the design of a reliable connecting joint.

An embodiment of the application provides an adjustable fixed bolster of apparatus is implanted to human heart, including base part, adjusting part and handle fixing base, the base part is used for fixing adjustable fixed bolster to corresponding operation workstation or rigid component on, adjusting part includes the connecting rod the both ends of connecting rod are formed with first joint and second joint, the second joint with base part's pivot is connected, first joint is connected with the convex surface bulb of handle fixing base, can make the connecting rod rotate and remove for the pivot through the effect of second joint, first joint includes the concave spherical seat that forms at the connecting rod end that sets up with connecting rod an organic whole, with concave spherical briquetting and the first staple bolt that concave spherical seat components of a whole that can function independently set up, concave spherical seat is formed with first concave spherical surface, concave spherical briquetting is formed with the second concave spherical surface, works as when concave spherical briquetting engages concave spherical seat, the first concave spherical surface of concave spherical briquetting encloses with the second concave spherical surface of concave spherical seat and forms the cavity that has roughly, first staple bolt leg portion and interior concave spherical surface briquetting enclose the inner circle spherical surface of concave spherical briquetting, thereby the staple bolt is applied to the inner circle spherical surface of concave spherical seat, thereby the staple bolt is to the staple bolt fixed bolster and the staple bolt is realized the convex surface of the staple bolt shank and the staple bolt convex surface of concave spherical ball and concave spherical seat, thereby the staple bolt is applied to the staple bolt.

In a preferred embodiment, a limiting boss is arranged on the concave spherical pressing block, a limiting groove is arranged on the concave spherical seat, and the limiting boss is matched with the limiting groove, so that the concave spherical pressing block arranged in the hoop inner circular surface of the first hoop cannot axially move.

Optionally, grooves are formed in the first concave spherical surface of the concave spherical surface seat and the second concave spherical surface of the concave spherical surface pressing block, so that the friction force between the first concave spherical surface and the convex ball head and the friction force between the second concave spherical surface and the convex ball head when the first hoop is locked are increased.

In a preferred embodiment, the first joint further comprises a pin, which is arranged in the holes of the first hoop and the concave spherical seat and limits the axial movement and rotation of the first hoop, so that the first hoop is always kept around the outer circles of the concave spherical seat and the concave spherical pressing block. The pin and the first hoop and the hole of the concave spherical seat can adopt the connection modes such as threaded connection, interference fit and the like.

In a preferred embodiment, through holes are formed in the anchor ear legs, and a locking screw and a first knob are matched to apply force to the anchor ear legs so as to tighten the inner circular surface of the anchor ear.

Optionally, the handle fixing seat comprises a guide rail, the guide rail is fixedly connected with the convex ball head, an implantation sheath mounting seat and a catheter sheath mounting seat are movably arranged on the guide rail, and when the cardiac prosthesis is performed, the implantation sheath mounting seat and the catheter sheath mounting seat can be moved to proper positions along the guide rail and then fixed on the guide rail.

Optionally, the second joint includes the flat briquetting of second staple bolt, translation seat, the translation seat has the wear to establish the hole, the wear to establish the hole and be used for holding flat briquetting and connecting rod, utilizes locking screw to pass flat briquetting, connecting rod, translation seat, second staple bolt and second knob threaded connection in proper order, through revolving soon the second knob realizes flat briquetting right the connecting rod compress tightly with the second staple bolt with the locking of base part's pivot is once revolved through revolving soon of second knob, realizes the connecting rod around the rotational freedom of base part's pivot axis, connecting rod wind the rotational freedom of locking screw, connecting rod are relative the locking of translation seat removal degree of freedom.

Optionally, a groove extending radially from the axis of the locking screw is formed in a contact surface where the translation seat is in contact with the second anchor ear, and friction force of two surface contacts is increased through interaction of the two contact surface grooves; preferably, the grooves of the two contact surfaces have the same configuration, so that more precise rotation angle adjustment of the translation seat relative to the second anchor ear is realized.

According to the technical scheme, the adjustable fixing support of the implantation instrument can firmly lock the first joint matched with the spherical surface by adopting the first joint matched with the spherical surface and the first protection of the lever effect, so that the risk that the handle fixing seat shakes and falls off in the operation process is reduced; through the split separation structure of the first concave spherical surface and the second concave spherical surface, the half-split spherical surface is easy to process, so that the contact area of the spherical surface is increased as much as possible, the friction force is larger after locking, and the spherical joint is more stable; when the first hoop is locked, the pressing force generated by the tightening force lock of the first hoop has a lever effect, so that the stability of fixing the bracket can be greatly improved; the joint is controlled to be locked and loosened through a knob, so that random rotation adjustment is realized, and the structure is simple and reliable; the operation of operating this adjustable fixed bolster for the conveyer pipe is to human vascular drag, extrusion and distortion degree minimum, thereby furthest alleviates the injury of operation in-process apparatus to the human body to and makes follow-up operation more smooth and easy.

Drawings

FIG. 1 is a schematic view of the overall structure of an adjustable fixing bracket according to the present invention;

FIG. 2 is an exploded view of the adjustable mounting bracket of the present invention;

FIG. 3 is a schematic view of a concave spherical press block structure according to the present invention;

FIG. 4 is a partial sectional view of the assembly structure of the concave spherical seat and the concave spherical pressing block according to the present invention;

FIG. 5 is a schematic structural view of a first hoop equipped with a locking screw according to the present invention;

FIG. 6 is a schematic diagram of the position of the trench in the present invention.

Description of reference numerals:

1-base part, 11-rotating shaft, 2-adjusting part, 21-connecting rod, 22-first joint, 221-concave spherical seat, 222-concave spherical pressing block, 2221-limit boss, 223-first hoop, 2231-hoop leg part, 2232-hoop inner circular surface, 224-pin, 23-second joint, 231-second hoop, 232-translation seat, 233-flat pressing block, 24-annular groove, 3-handle fixing seat, 31-convex spherical head, 32-guide rail, 33-implantation sheath mounting seat, 34-catheter sheath mounting seat, 4-first knob, 5-second knob and 6-groove.

Detailed Description

In order that the objects, technical solutions and advantages of the present invention will become more apparent, the present invention will be further described in detail with reference to the accompanying drawings in conjunction with the following specific embodiments.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The terms "comprises," "comprising," and the like, as used herein, specify the presence of stated features, steps, operations, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, or components.

All terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art unless otherwise defined. It is noted that the terms used herein should be interpreted as having a meaning that is consistent with the context of this specification and should not be interpreted in an idealized or overly formal sense.

Certain embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosure are shown. Indeed, various embodiments of the disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

The embodiment of the application provides an adjustable fixing bracket of a human heart implantation instrument, and the specific structure is as shown in fig. 1, the adjustable fixing bracket comprises a base part 1, an adjusting part 2 and a handle fixing seat 3, the base part 1 is used for fixing the adjustable fixing bracket to a corresponding operating table or a rigid component, the adjusting part 2 comprises a connecting rod 21, a first joint 22 and a second joint 23 are formed at two ends of the connecting rod 21, the second joint 23 is connected with a rotating shaft 11 of the base part 1, the first joint 22 is connected with a ball head convex surface 31 of the handle fixing seat 3, the connecting rod 21 can rotate and move relative to the rotating shaft 11 under the action of the second joint 23, the first joint 22 comprises a concave spherical seat 221 which is integrally arranged with the connecting rod 21 and formed at the tail end of the connecting rod 21, a concave pressing block 222 and a first hoop 223 which are separately arranged corresponding to the concave spherical seat 221, as shown in fig. 2, the concave-spherical seat 221 is formed with a first concave-spherical surface, the concave-spherical press block 222 is formed with a second concave-spherical surface, when the concave-spherical press block 222 is engaged with the concave-spherical seat 221, the second concave-spherical surface of the concave-spherical press block 222 and the first concave-spherical surface of the concave-spherical seat 221 enclose to form a cavity with a substantially spherical shape, the first anchor ear 223 has an anchor ear leg 2231 and an anchor ear inner circular surface 2232, the anchor ear inner circular surface 2232 acts on the outer peripheries of the concave-spherical seat 221 and the concave-spherical press block 222, and by applying a force to the anchor ear leg 2231, the anchor ear inner circular surface 2232 is tightened, so that the friction of the concave-spherical seat 221 and the concave-spherical press block 222 on the convex spherical head 31 is increased, the rotation of the convex spherical head 31 in the cavity is limited, and the fixing of the handle fixing seat 3 is achieved.

In a preferred embodiment, and referring to the schematic structural diagram of the concave spherical pressing block 222 in fig. 3 in detail, a limiting boss 2221 is disposed on the concave spherical pressing block 222, a limiting groove is disposed on the concave spherical seat 221, and the limiting boss 2221 is matched with the limiting groove, so that the concave spherical pressing block 222 disposed in the hoop inner circular surface 2232 of the first hoop 223 does not move axially.

In a preferred embodiment, fig. 4 is a partial sectional view of the concave-spherical seat and concave-spherical press block assembly structure, the first joint 22 further includes a pin 224 disposed in the holes of the first anchor ear 223 and the concave-spherical seat 221, and limiting the axial movement and rotation of the first anchor ear 223, so that the first anchor ear 223 is always kept around the outer circle of the concave-spherical seat 221 and the concave-spherical press block 222. The pin 224, the first anchor ear 223 and the hole of the concave spherical seat 221 may be connected by a screw thread or an interference fit.

Optionally, at least one annular groove 24 is provided on the first concave spherical surface of the concave spherical seat 221 and the second concave spherical surface of the concave spherical surface pressing block 222, only the annular groove 24 provided on the second concave spherical surface is shown in fig. 3, an annular groove (not shown) is also provided on the first concave spherical surface, and the annular groove 24 is utilized to increase the friction force between the first concave spherical surface and the convex spherical head 31 when the first anchor ear 223 is locked.

In a preferred embodiment, through holes are provided in the anchor ear legs 2231, and referring to fig. 4-5, a locking screw is engaged with the first knob 4 to apply a force to the anchor ear legs 2231, so as to tighten the anchor ear inner circular surface 2232, and since the anchor ear legs 2231 and the anchor ear inner circular surface 2232 have a certain distance, when the locking screw is applied to the anchor ear legs 2231, an anchor ear lever type lock is formed, so as to increase the locking force of the concave spherical seat 221 and the concave spherical pressing block 222.

Optionally, the handle holder 3 includes a guide rail 32, the guide rail 32 is fixedly connected to the convex ball head 31, an implantation sheath mount 33 and an introducer sheath mount 34 are movably disposed on the guide rail 32, and the implantation sheath mount 33 and the introducer sheath mount 34 can be moved to a proper position along the guide rail 32 and then fixed on the guide rail 32 when performing the heart repair.

Optionally, the second joint 23 includes a second hoop 231, a horizontal movement seat 232 and a horizontal movement block 233, the horizontal movement seat 232 has a through hole, the through hole is used for accommodating the horizontal movement block 233 and the connecting rod 21, the locking screw sequentially penetrates through the horizontal movement block 233, the connecting rod 21, the horizontal movement seat 232, the second hoop 231 and the second knob 5 to be in threaded connection, the horizontal movement block 233 is enabled to be aligned to the connecting rod 21 and the second hoop 231 is enabled to be locked with the rotating shaft 11 of the base component 1 by screwing the second knob 5, and the connecting rod 21 is enabled to rotate around the rotational freedom of the axis of the rotating shaft 11 of the base component 1, the connecting rod 21 is enabled to rotate around the rotational freedom of the axis of the locking screw, and the connecting rod 21 is enabled to move around the horizontal movement seat 232.

Optionally, a groove 6 extending radially from the axis of the locking screw is provided on the contact surface where the translation seat 232 and the second anchor ear 231 are in contact with each other, and with reference to the structure in fig. 6, the friction force when the two contact surfaces are in contact is increased through the interaction of the grooves 6 of the two contact surfaces, so as to increase the fastening performance of the translation seat 232 and the second anchor ear 231; preferably, the grooves 6 of both contact surfaces have the same configuration, so as to achieve a more precise rotational angle adjustment of the translation seat 232 with respect to the second anchor ear 231.

Referring to fig. 1-2, the adjustable fixation stent of the present invention is described as applied to a tricuspid valve repair procedure:

1) When the tricuspid valve of a patient is repaired, the base component 1 is fixed on an operating table or other working tables, the first joint 22 and the second joint 23 are loosened, the guide rail 32 of the handle fixing seat 3 is moved, the implantation sheath mounting seat 33 and the catheter sheath mounting seat 34 which are arranged on the guide rail 32 reach the vicinity of a target position, and then the first joint 22 and the second joint 23 are controlled to be locked.

2) After the control sheath is delivered into the human jugular vein and reaches the vicinity of the target site, the sheath handle is secured to the sheath mount 34.

3) The first joint 22 and the second joint 23 are loosened, the handle fixing seat 3 is moved and/or rotated, so that the conveying pipe and the handle axis which are exposed outside the human body are parallel and coaxial with the target blood vessel, and after accurate adjustment, the first joint 22 and the second joint 23 are screwed down to fix the adjustable fixing bracket. At the moment, the pulling, extrusion and distortion degrees of the conveying pipe to the blood vessel of the human body are minimum, so that the injury of the instrument to the human body in the operation process is reduced to the maximum extent, and the subsequent operation is smoother.

4) The implantation sheath system (not shown, usually a surgical implant component) is inserted from the end of the implantation sheath handle and transported along the delivery tube to the vicinity of the target position of the human body, at which time the implantation sheath handle is fixed to the implantation sheath mounting seat 33 of the guide rail 32.

5) The position and posture of the implant sheath handle and the catheter sheath handle are observed, and if necessary, the first joint 22 and the second joint 23 can be loosened again, and the position and the angle of the implant sheath mounting seat 33 and the catheter sheath mounting seat 34 can be finely adjusted. In the process, the first joint 22 and the second joint 23 can be adaptively and passively adjusted, so that the implantation sheath mounting seat 33 and the catheter sheath mounting seat 34 can be randomly adjusted until the ideal position and posture are achieved, and after the adjustment is completed, the first joint and the second joint 23 are locked.

6) And after the adjustable fixing support is fixed, the handle is continuously operated until the operation is finished.

The adjustable fixing support is applied to the tricuspid valve repair, the first joint 22 matched with the spherical surface can be firmly locked by adopting the first joint 22 matched with the spherical surface and the first protection of the lever effect, and the risk that the handle fixing seat 3 shakes and falls off in the operation is reduced; the handle fixing seat can be adjusted freely in the space direction, so that the conveying pipe exposed outside the human body, the axis of the handle and the target blood vessel are parallel and coaxial, the pulling, extruding and twisting degrees of the conveying pipe on the blood vessel of the human body are reduced, the injury of instruments to the human body in the operation process is reduced to the maximum extent, and the subsequent operation is smoother.

Claims (9)

1. An adjustable fixing support of a human heart implanting instrument comprises a base part (1), an adjusting part (2) and a handle fixing seat (3), wherein the adjusting part (2) comprises a connecting rod (21), a first joint (22) and a second joint (23) are formed at two ends of the connecting rod (21), the second joint (23) is connected with a rotating shaft (11) of the base part (1), the first joint (22) is connected with a convex ball head (31) of the handle fixing seat (3), the connecting rod (21) can rotate and move relative to the rotating shaft (11) under the action of the second joint (23), the first joint (22) comprises a concave spherical seat (221) which is integrally arranged with the connecting rod (21) and formed at the tail end of the connecting rod (21), a concave spherical pressing block (222) and a first anchor ear (223) which are separately arranged corresponding to the concave spherical seat (221), the concave spherical seat (221) is formed with a first concave spherical pressing block, the spherical pressing block (222) is formed with a second concave spherical block, and when the concave spherical seat (221) is connected with the concave spherical seat (223) and the second spherical pressing block (223) is approximately combined with the concave spherical seat (223), the concave spherical seat (221) and the second anchor ear, the concave spherical seat (221) is formed with a first anchor ear, the concave spherical pressing block (223), the concave spherical seat (221) which is formed with the second anchor ear which is approximately enclosed by the concave spherical seat (1), the hoop inner circle (2232) acts on the peripheries of the concave spherical seat (221) and the concave spherical pressing block (222), and the hoop inner circle (2232) is tightened by applying force to the hoop leg parts (2231), so that the friction force of the concave spherical seat (221) and the concave spherical pressing block (222) on the convex spherical head (31) is increased, and the rotation of the convex spherical head (31) in the cavity is limited.

2. The adjustable fixing bracket according to claim 1, wherein a limit boss (2221) is provided on the concave spherical pressing block (222), a limit groove is provided on the concave spherical seat (221), and the limit boss (2221) is engaged with the limit groove.

3. The adjustable fixing bracket according to claim 1, characterized in that the first joint (22) further comprises a pin (224) disposed in the holes of the first anchor ear (223) and the concave spherical seat (221) to limit the axial movement and rotation of the first anchor ear (223).

4. The adjustable fixing bracket according to claim 1, characterized in that at least one annular groove (24) is provided on both the first concave spherical surface of the concave spherical seat (221) and the second concave spherical surface of the concave spherical pressing block (222).

5. The adjustable fixing bracket as claimed in claim 1, wherein a through hole is provided in the hoop leg portion (2231), and a locking screw inserted into the through hole is engaged with the first knob (4) to apply a force to the hoop leg portion (2231).

6. The adjustable fixing bracket according to claim 1, characterized in that the handle fixing seat (3) comprises a guide rail (32), the guide rail (32) is fixedly connected with the convex spherical head (31), an implantation sheath mounting seat (33) and a catheter sheath mounting seat (34) are movably arranged on the guide rail (32), and the implantation sheath mounting seat (33) and the catheter sheath mounting seat (34) can be moved to proper positions along the guide rail (32) and then fixed on the guide rail (32) when the heart repair operation is carried out.

7. The adjustable fixing support according to claim 1, characterized in that the second joint (23) comprises a second hoop (231), a translation seat (232) and a flat pressing block (233), the translation seat (232) has a through hole for accommodating the flat pressing block (233) and the connecting rod (21), and a locking screw is used for sequentially passing through the flat pressing block (233), the connecting rod (21), the translation seat (232) and the second hoop (231) to be in threaded connection with the second knob (5).

8. The adjustable fixing bracket according to claim 7, characterized in that the contact surface of the translation seat (232) and the second anchor ear (231) is provided with a groove (6) extending radially from the axis of the locking screw.

9. A method for using an adjustable fixing support according to claim 1, characterized in that it comprises the following operations:

1) fixing a base component (1) on an operating bed, loosening a first joint (22) and a second joint (23), moving a guide rail (32) of a handle fixing seat (3), enabling an implantation sheath mounting seat (33) and a catheter sheath mounting seat (34) arranged on the guide rail (32) to reach the vicinity of a target position, and then controlling the first joint (22) and the second joint (23) to be locked;

2) After the control catheter sheath is conveyed into a jugular vein of a human body and reaches the position near a target position, a handle of the catheter sheath is fixed on a catheter sheath mounting seat (34);

3) Loosening the first joint (22) and the second joint (23), moving and/or rotating the handle fixing seat (3) to enable the conveying pipe and the handle axis which are exposed outside the human body to be parallel and coaxial with the target blood vessel, and after accurate adjustment, screwing the first joint (22) and the second joint (23) to fix the adjustable fixing bracket;

4) The implantation sheath system is inserted from the tail end of the implantation sheath handle and is conveyed to the position near the target position of the human body along the conveying pipe, and at the moment, the implantation sheath handle is fixed on an implantation sheath mounting seat (33) of a guide rail (32);

5) Observing the positions and postures of the implantation sheath handle and the catheter sheath handle, if necessary, loosening the first joint (22) and the second joint (23) again, finely adjusting the positions and the angles of the implantation sheath installation seat (33) and the catheter sheath installation seat (34), wherein in the process, the first joint (22) and the second joint (23) can be adaptively and passively adjusted, so that the implantation sheath installation seat (33) and the catheter sheath installation seat (34) can be randomly adjusted until the ideal positions and postures are reached, and after the adjustment is completed, locking the first joint (22) and the second joint (23);

6) And after the adjustable fixing support is fixed, the handle is continuously operated until the operation is finished.

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