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CN211934163U - Insertion type locking device - Google Patents

Insertion type locking device
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Publication number
CN211934163U
CN211934163UCN201922393431.XUCN201922393431UCN211934163UCN 211934163 UCN211934163 UCN 211934163UCN 201922393431 UCN201922393431 UCN 201922393431UCN 211934163 UCN211934163 UCN 211934163U
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China
Prior art keywords
push rod
chuck
outer tube
flexible inner
inner tube
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CN201922393431.XU
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Chinese (zh)
Inventor
李阳
梁伟林
张庭超
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Hangzhou Valgen Medtech Co Ltd
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Hangzhou Valgen Medtech Co Ltd
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Priority to CN201922393431.XUpriorityCriticalpatent/CN211934163U/en
Priority to PCT/CN2020/120853prioritypatent/WO2021129058A1/en
Application grantedgrantedCritical
Publication of CN211934163UpublicationCriticalpatent/CN211934163U/en
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Abstract

The utility model provides an intervention type locking device, which comprises a chuck, a push rod component, a transmission component and an outer sleeve component; the push rod component comprises a push rod arranged outside the chuck; the axial position of the chuck is fixed and the chuck has elasticity, when in an initial state, the chuck accommodates a locking nail penetrated with a suture line, and the part of the chuck close to the push rod gradually inclines outwards from the near end to the far end; the transmission component comprises a threaded transmission component and a flexible inner pipe fixedly connected with the threaded transmission component, and the threaded transmission component is rotationally connected with the push rod component; the flexible inner tube rotates to drive the thread transmission part to rotate, and the rotation of the thread transmission part drives the push rod component to move along the axial direction, so that the push rod pushes or loosens the chuck, and the chuck is forced to press the locking nail to deform so as to lock the suture thread penetrating through the locking nail or release the locking nail; the outer sleeve component comprises a hard outer pipe sleeved outside the transmission component and the flexible inner pipe, and a plurality of first slot units are arranged on the pipe wall of the outer pipe along the axial direction, so that the outer pipe has rigidity and flexibility.

Description

Insertion type locking device
Technical Field
The utility model relates to the technical field of medical equipment, especially, relate to an intervention formula keying device.
Background
The operation of knotting and fixing suture is often required in the operation, and the traditional surgical operation is operated under the condition of open vision, and the knotting is usually carried out manually by a doctor. With advances in technology, various minimally invasive and interventional procedures are becoming increasingly common, such as laparoscopic procedures, transcatheter interventional procedures, and the like. These procedures require only a small operating window to be cut into the patient's body, whereby an instrument such as an endoscope or interventional catheter is inserted into the patient's body to a predetermined site for treatment. In such procedures, if knotting or fastening of the suture in the patient is required, the operator is usually required to perform operations outside the patient through the small operation window to knot or fasten the suture in the patient, which requires the use of a suture locking device.
The existing suture locking device fixes the suture penetrating through the inner cavity of the locking nail by a locking nail with a hollow inner cavity and a clamping head which is matched with the locking nail and applies pressure to the locking nail to force the locking nail to deform. As the suture locking device needs to be inserted into a human body, in order to be matched with the physiological anatomical structure of a human body lumen, a tube body between a chuck and a handle of the suture locking device and parts arranged in the tube body need to have certain flexibility. Generally, prior suture locking devices drive a collet against a locking pin by manipulating a handle to push a flexible member disposed within a body and a rigid member secured to the distal end of the flexible member distally. However, on one hand, since the suture thread is locked by using direct pushing force, the flexible part is easy to bend and bend in the process of transmitting the pushing force on the flexible part, the pushing force is greatly lost, the pushing force cannot be effectively transmitted to the rigid part at the far end of the flexible part, so that the chuck cannot effectively press the locking nail, and the suture thread cannot be reliably locked by the locking nail; on the other hand, when the driving force required by the deformation of the locking nail is large, the flexible outer tube cannot provide enough supporting force, the flexible part bends and folds in the outer tube, the shape of the outer tube is affected, the outer tube deforms, the internal blood vessel and the tissue of a patient are squeezed, and the risk is high.
SUMMERY OF THE UTILITY MODEL
The to-be-solved technical problem of the utility model lies in providing an intervention formula keying device to prior art's defect, it has rigidity and flexibility concurrently, can reduce thrust loss, ensures that the stylolite is locked reliably by the locking nail, can make the outer tube have sufficient holding power again.
In order to solve the technical problem, the utility model firstly provides an intervention type locking device, which comprises a chuck, a push rod component arranged outside the chuck, a transmission component connected with the push rod component, and an outer sleeve component sleeved outside the chuck, the push rod component and the transmission component; the push rod assembly comprises a push rod arranged outside the chuck; the axial position of the chuck is fixed and the chuck has elasticity, when in an initial state, the chuck accommodates a locking nail with a suture line, and the part of the chuck close to the push rod is gradually inclined outwards from the near end to the far end; the transmission assembly drives the push rod assembly to move axially, so that the push rod abuts against the chuck to force the chuck to press the locking nail to deform so as to lock a suture thread penetrating through the locking nail; the outer sleeve component comprises a hard outer pipe sleeved outside the transmission component, and a plurality of first slot units are arranged on the pipe wall of the outer pipe in the axial direction.
Preferably, the plurality of first slot units are arranged on the tube wall of the outer tube in an axially uniform or non-uniform arrangement.
Preferably, each of the first slot units includes N arc-shaped slots spaced from each other in the axial direction and penetrating through the wall of the outer tube, where N is a positive integer greater than or equal to 2, each of the slots extends in the circumferential direction of the outer tube, and two adjacent slots are offset from each other in the circumferential direction of the outer tube.
Preferably, in each of the first slot units, the arc length of each of the slots is equal, and all the slots of each of the first slot units enclose at least one turn in the circumferential direction of the outer tube.
Preferably, in each first slot unit, two adjacent slots are relatively rotated by 360/N degrees.
Preferably, N is 2, 3, 4, 5 or 6, and in each first slot unit, two adjacent slots are correspondingly rotated by 180 degrees, 120 degrees, 90 degrees, 72 degrees or 60 degrees relatively.
Preferably, each of the slots extends along the circumference of the outer tube over an arc length greater than or equal to 1/2 and less than or equal to 2/3 of the circumference of the outer tube.
Preferably, the width of each slot is in the range of 0.15mm to 0.5 mm, and the distance between every two adjacent slots is in the range of 1 mm to 3.5 mm.
Preferably, the outer sleeve assembly further comprises a sleeve fixedly connected to the distal end of the outer tube, the sleeve accommodates the collet and the push rod assembly, and the collet is fixedly connected to the sleeve.
Preferably, the transmission assembly comprises a threaded transmission part and a flexible inner tube fixedly connected with the threaded transmission part, and the threaded transmission part is rotatably connected with the push rod assembly; the flexible inner tube rotates to drive the threaded transmission part to rotate, and the push rod assembly is driven to move axially by the rotation of the threaded transmission part.
Preferably, the screw transmission member is a transmission screw rod; the threaded transmission part is fixedly connected with a connecting piece, the connecting piece is rotationally connected with the push rod component, and the threaded transmission part synchronously rotates and axially moves to drive the push rod component to axially move; or the thread transmission part is directly screwed with the push rod component and only rotates to drive the push rod component to move along the axial direction.
Preferably, the flexible inner tube further comprises a driving member for driving the flexible inner tube and the screw thread transmission member to rotate, and the driving member is fixedly connected to the proximal end of the flexible inner tube.
Preferably, the flexible pipe comprises a handle, the driving part is rotatably arranged at the proximal end of the handle, a through groove is axially formed in the handle, and the proximal end of the flexible inner pipe penetrates through the through groove and is fixedly connected to the driving part.
Preferably, a rotation hole is formed in the proximal end face of the handle around the through groove, and a rotation shaft rotatably inserted into the rotation hole is arranged at the distal end of the driving piece.
Preferably, a guide rod is fixedly inserted in the handle, a guide groove is axially formed in the guide rod, the near end of the flexible inner tube is movably contained in the guide groove, and the near end of the outer tube is fixedly connected with the far end of the guide rod.
Preferably, the push rod assembly further comprises a base coaxial with the screw transmission member, and the push rod is fixedly connected to the base and extends in the axial direction; the connecting piece is rotatably connected with the base, and an axial limiting structure is arranged between the connecting piece and the base; or the screw thread transmission piece is directly screwed with the base, and the axial position of the screw thread transmission piece relative to the sleeve is fixed.
According to the intervention type locking device, on one hand, the rotation of the flexible inner tube and the thread transmission part drives the push rod to move towards the far end relative to the chuck along the axial direction, the push rod slidably pushes against the chuck to enable the chuck to deform and press the locking nail to deform so as to lock a suture thread penetrating through a cavity of the locking nail, the rotation torque of the flexible inner tube and the thread transmission part is converted into axial thrust for the thread transmission part to drive the push rod to axially move so as to drive the push rod to axially slidably push or loosen the chuck, and the thread transmission part is rigid and has a very short length compared with the flexible inner tube, so that the thrust is not lost, the thrust can be smoothly and effectively transmitted to the push rod, the chuck can effectively press the locking nail to enable the locking nail to deform fully, and the suture thread is guaranteed to be reliably locked; on the other hand, the plurality of first slot units are arranged on the wall of the hard outer tube along the axial direction, so that the outer tube has both rigidity and flexibility, the flexibility enables the outer tube to bend in the human body lumen in an adaptive manner, the rigidity enables the outer tube to provide enough supporting force, even if the flexible inner tube drives the screw transmission member to further bend and fold in the flexible outer tube when rotating, the shape of the outer tube cannot be influenced, the outer tube is prevented from extruding the internal blood vessels and tissues of a patient under the influence of the flexible inner tube, and the operation risk is reduced.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.
Fig. 1 is a schematic perspective view of an intervention type locking device according to a first embodiment of the present invention.
Fig. 2 is a sectional view taken along line II-II in fig. 1.
Fig. 3 is a perspective view of the outer tube of fig. 1.
Fig. 4 is a side view schematically showing the structure of the outer tube of fig. 3.
FIG. 5 is a perspective view of a second form of construction of the outer tube;
FIG. 6 is a perspective view of a third form of construction of the outer tube;
FIG. 7 is a schematic side view of the tube of FIG. 6;
fig. 8 is a perspective view of the flexible inner tube of fig. 2.
Fig. 9 is a cross-sectional view of the flexible inner tube of fig. 8.
Fig. 10 is an enlarged view of VII portion in fig. 2.
Fig. 11 is a schematic perspective view of a locking pin pressed by a chuck of the intervention type locking device according to the first embodiment of the present invention.
Fig. 12 is a cross-sectional view of the locking pin of fig. 11.
Fig. 13 is a schematic structural view of a collet of the intrusive locking device of fig. 10.
Fig. 14 is a schematic perspective view of the push rod assembly of the engagement locking device in fig. 10.
Fig. 15 is a cross-sectional structural schematic view of the push rod assembly of fig. 14.
Fig. 16 is a cross-sectional view of the push rod assembly, transmission assembly and drive member of the intrusive linking device of fig. 2.
Fig. 17 is an enlarged view of the push rod assembly and a portion of the transmission assembly of fig. 16.
Fig. 18 is a perspective view of the handle and guide bar of fig. 2.
Fig. 19 is an exploded view of the handle and guide bar of fig. 18.
Fig. 20 is a cross-sectional structural schematic view of the handle of fig. 19.
Fig. 21 is a perspective view of the assembled structure of the handle, guide rod, outer tube, connecting cylinder, sleeve and end cap of fig. 2.
FIG. 22 is a cross-sectional view of the handle, guide rod, outer tube, connector, sleeve and end cap of FIG. 21.
Fig. 23-25 are schematic views of the interventional locking device provided in the first embodiment of the present invention for use in a tricuspid valve repair procedure.
Fig. 26-28 are schematic views illustrating a process for fixing a suture to a locking nail of the intervention type locking device according to the first embodiment of the present invention.
Fig. 29 is an enlarged partial view of the intrusive locking device of fig. 26.
Fig. 30 is an enlarged partial view of the intrusive locking device of fig. 27.
Fig. 31 is an enlarged partial view of the intrusive locking device of fig. 28.
Fig. 32 is an enlarged view of the XXIX portion in fig. 25.
Fig. 33 is a schematic cross-sectional view of an intervention type locking device according to a second embodiment of the present invention.
FIG. 34 is a perspective view of the flexible inner tube of the intrusive locking device of FIG. 33.
Fig. 35 is an enlarged view of XXXIII in fig. 33.
Fig. 36 is a schematic structural diagram of an intervention type locking device according to a third embodiment of the present invention.
FIG. 37 is a perspective view of the flexible inner tube of FIG. 36.
FIG. 38 is a cross-sectional view of the flexible inner tube of FIG. 37.
Fig. 39 is a schematic perspective view of a flexible inner tube in an insertion type locking device according to a fourth embodiment of the present invention.
FIG. 40 is a side view of the flexible inner tube of FIG. 39.
FIG. 41 is an enlarged view of the XLIII portion of FIG. 40.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by a person of ordinary skill in the art without any creative effort belong to the protection scope of the present invention.
Furthermore, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the attached drawing figures and, thus, are used in a better and clearer sense to describe and understand the present invention rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the invention.
Orientation definition: for clarity of description, the end of the surgical procedure that is closer to the operator will be referred to hereinafter as the "proximal end" and the end that is further from the operator will be referred to hereinafter as the "distal end"; the axial direction is parallel to the direction of the connection line of the center of the far end and the center of the near end of the medical instrument; the foregoing definitions are for convenience only and are not to be construed as limiting the present invention.
Referring to fig. 1 and 2, a first embodiment of the present invention provides aninsertion locking device 100, which includes achuck 22, apush rod assembly 40 disposed outside thechuck 22, atransmission assembly 60 connected to a proximal end of thepush rod assembly 40, a drivingmember 70 for driving thetransmission assembly 60 to drive thepush rod assembly 40 to move axially, acasing assembly 80 sleeved outside thechuck 22, thepush rod assembly 40 and thetransmission assembly 60, and ahandle 90 disposed at a proximal end of thecasing assembly 80. The distal end of the clampinghead 22 is provided with agap 25 for placing the lockingnail 300, the lockingnail 300 is provided with athreading cavity 301 along the axial direction, and thethreading cavity 301 is used for threading a suture. The push rod assembly 40 includes a push rod 42 disposed outside the cartridge 22; the axial position of the clamping head 22 is fixed and has elasticity, when in an initial state, the locking nail 300 with a suture line is accommodated in the clamping head 22, and the part of the clamping head 22 close to the push rod 42 is gradually inclined outwards from the near end to the far end; the transmission assembly 60 comprises a threaded transmission member 62 and a flexible inner tube 64 fixedly connected with the threaded transmission member 62, and the threaded transmission member 62 is rotatably connected with the push rod assembly 40; the flexible inner tube 64 rotates to drive the screw transmission member 62 to rotate, and the rotation of the screw transmission member 62 drives the push rod assembly 40 to move axially, so that the push rod 42 pushes or releases the collet 22, so as to force the collet 22 to press the locking nail 300 to deform and lock the suture thread passing through the locking nail 300 or release the locking nail 300; the outer sleeve assembly 80 includes a hard outer tube 84 sleeved outside the transmission assembly 60 and the flexible inner tube 64, and a plurality of first slot units 840 are axially arranged on the wall of the outer tube 84, so that the outer tube 84 has rigidity and flexibility, and is suitable for the intervention type locking process.
In the insertion-type locking device 100 provided by the present application, on one hand, the rotation of the flexible inner tube 64 and the threaded driving element 62 drives the push rod 42 to move distally along the axial direction relative to the chuck 22, the push rod 42 slidably pushes against the chuck 22, so that the chuck 22 deforms to press the locking nail 300 to deform, to lock the suture thread passing through the threading cavity 301 of the locking nail 300, the rotation torque of the flexible inner tube 64 and the screw transmission element 62 is converted into an axial pushing force that the screw transmission element 62 drives the push rod 42 to move axially, so as to drive the push rod 42 to push or release the chuck 22 in an axial sliding manner, since the screw driver 62 is rigid and has a very short length compared to the flexible inner tube 64, the thrust is not lost, the thrust can be smoothly and efficiently transmitted to the push rod 42, therefore, the clamping head 22 can effectively press the locking nail 300 to enable the locking nail 300 to be deformed fully, and the suture line is ensured to be reliably locked by the locking nail 300; on the other hand, the plurality of first slot units 840 are axially arranged on the wall of the hard outer tube 84, so that the outer tube 84 has both rigidity and flexibility, the flexibility enables the outer tube 84 to bend in the human body lumen in an adaptive manner, the rigidity enables the outer tube 84 to provide enough supporting force, even if the flexible inner tube 64 further bends and folds in the outer tube 84 when driving the screw driver 62 to rotate, the shape of the outer tube 84 is not affected, the outer tube 84 is prevented from extruding the internal blood vessels and tissues of the patient under the influence of the flexible inner tube 64, and the risk of the operation is reduced. In addition, the flexibleinner tube 64 only rotates and is not pushed, so that thepush rod 42 and the clampinghead 22 cannot swing or shake relative to the flexibleinner tube 64, and the tearing of the seam point can be avoided.
Alternatively, a plurality offirst slot units 840 may be arranged on the wall of theouter tube 84 in a uniform or non-uniform manner along the axial direction.
Theouter tube 84 is formed by cutting a plurality offirst slot units 840 arranged along the axial direction on the wall of the hard tube by using a laser cutting device. Referring to fig. 1 and 3-7, eachfirst slot unit 840 includes N arc-shapedslots 841 axially spaced apart from each other and penetrating the wall of theouter tube 84, where N is a positive integer greater than or equal to 2. Eachslot 841 in eachfirst slot unit 840 extends along the circumferential direction of theouter tube 84, and adjacent twoslots 841 are mutually shifted in the circumferential direction of theouter tube 84; theouter tube 84 has flexibility in a portion corresponding to eachslot 841, and theouter tube 84 has rigidity in a portion corresponding to between each adjacent twoslots 841. Different values of N allow theouter tube 84 to bend in different directions and different degrees, and the greater the value of N, the more theouter tube 84 can bend in, and the more the overall flexibility of theouter tube 84 will be apparent.
In each of thefirst slot units 840, eachslot 841 is a circular arc-shaped slot extending along the circumferential direction of theouter tube 84, and eachslot 841 does not open a complete circle around the circumferential direction of theouter tube 84, but all theslots 841 enclose at least one circle in the circumferential direction of theouter tube 84.Outer tube 84 is capable of compliant bending within tortuous body lumens due to the plurality ofslots 841 cut out to provide flexibility, the portions ofouter tube 84 not penetrated byslots 841 remain somewhat rigid, and the portions ofouter tube 84 not penetrated byslots 841 correspond to different peripheral locations ofouter tube 84 such thatouter tube 84 has sufficient support to resist the effects of flexibleinner tube 64 as it changes configuration onouter tube 84. Theouter tube 84 may be made of stainless steel, nitinol, cobalt-chromium alloy, etc., in this embodiment, theouter tube 84 is made of nitinol tube and cut by a laser cutting device.
Specifically, referring to fig. 3 and 4, in the first structural form of theouter tube 84, N is 3, i.e., eachfirst slot unit 840 includes 3 arc-shapedslots 841. In eachfirst slot unit 840, 3slots 841 are spaced from each other in the axial direction of theouter tube 84, and adjacent twoslots 841 are staggered from each other in the circumferential direction of theouter tube 84. Eachslot 841 extends along the circumference ofouter tube 84 over an arc length greater than or equal to 1/2 the circumference ofouter tube 84 and less than or equal to 2/3 the circumference ofouter tube 84; the arc length of eachslot 841 extending along the circumferential direction ofouter tube 84 is greater than or equal to 1/2 of the circumference ofouter tube 84, so that the arc length ofslot 841 is not too short, and better flexibility ofouter tube 84 is ensured; eachslot 841 extends circumferentially ofouter tube 84 over an arc length less than or equal to 2/3 of the circumference ofouter tube 84 to ensure thatslot 841 does not extend excessively long and thatouter tube 84 is also relatively rigid. The sum of the arc lengths of all of theslots 841 of eachfirst slot unit 840 is greater than or equal to the circumference of theouter tube 84.Slots 841 in eachfirst slot unit 840 ofouter tube 84 provideouter tube 84 with flexible properties, and the wall ofouter tube 84 providesouter tube 84 with rigid properties in the solid area between each adjacent twofirst slots 841, thereby providingouter tube 84 with both rigidity and flexibility. Preferably, the arc length of eachslot 841 is equal within eachfirst slot unit 840.
Further, in eachfirst slot unit 840, the relative rotation between twoadjacent slots 841 is 360/N degrees, i.e., the relative rotation angle between twoadjacent slots 841 in eachfirst slot unit 840 is equal to 360 degrees divided by N. In particular, as shown in fig. 3 and 4 for theouter tube 84, eachfirst slot unit 840 includes 3slots 841, and the relative rotational angle between twoadjacent slots 841 is 120 degrees.
Eachslot 841 has a slot width ranging from 0.15mm to 0.5 mm, and the distance between twoadjacent slots 841 ranges from 1 mm to 3.5 mm, so that theouter tube 84 has superior flexibility and moderate rigidity. In this embodiment, eachslot 841 has a slot width of 0.3mm, and a distance between every twoadjacent slots 841 is 1.0 mm.
Referring to fig. 5, in the second structural form of the outer tube 83, each of thefirst slot units 840 includes 4slots 841, i.e., N is 4, and the relative rotation angle between twoadjacent slots 841 is 90 degrees, and the remaining structures are the same as the first structural form of theouter tube 84, and are not repeated herein. It is noted that theouter tube 84 of the second configuration shown in fig. 5 is bent in a greater direction than theouter tube 84 of the first configuration shown in fig. 3 and 4, and theouter tube 84 is more flexible as a whole.
Referring to fig. 6 and 7, in a third structural form of the outer tube 83, eachfirst slot unit 840 includes 6slots 841, that is, the value of N is 6, and the relative rotation angle between twoadjacent slots 841 is 60 degrees, and the remaining structures are the same as the first structural form of theouter tube 84, and are not repeated herein. It is to be noted that the bending direction of theouter tube 84 of the third configuration is the most among theouter tubes 84 of the aforementioned three configurations, and the flexibility of theouter tube 84 as a whole is optimal.
Of course, the number ofslots 841 in eachfirst slot unit 840 can also be set to 2, 5 or more than 6 according to actual needs.
Referring to fig. 2 and 8 to 10, thetransmission assembly 60 further includes a flexibleinner tube 64 fixedly connected to thescrew transmission member 62, and anouter tube 84 is sleeved outside the flexibleinner tube 64. The flexibleinner tube 64 may be made of stainless steel, nitinol, cobalt chrome, or the like. In this embodiment, the flexibleinner tube 64 is formed by spirally winding wire materials, the outer diameter of the flexibleinner tube 64 is smaller than the inner diameter of theouter tube 84, the number of the wire layers of the flexibleinner tube 64 is 2-6, the wire diameter of the wire materials is 0.25-1.2 mm, the thread pitch is 0.25-1.5 mm, and the gap between the wire materials in the same layer is 0-0.15 mm. In this embodiment, the wire material of the flexibleinner tube 64 is stainless steel wire, and the wall thickness of the flexibleinner tube 64 is the thickness of two layers of the laminated wire material. Rotating the flexibleinner tube 64 can drive the threaded drivingmember 62 to move axially along the rotating edge, so as to drive thepush rod 42 to move axially to push or release thechuck 22.
Further, aflexible core rod 66 is inserted into the inner cavity of the flexibleinner tube 64, and preferably, thecore rod 66 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or the like. In this embodiment, thecore rod 66 is made of stainless steel, the flexibleinner tube 64 and the distal end of thecore rod 66 are fixedly connected to thescrew transmission member 62, and the flexibleinner tube 64 and the proximal end of thecore rod 66 are fixedly connected to the drivingmember 70; the drivingmember 70 can drive the flexibleinner tube 64, thecore rod 66 and thescrew driver 62 to rotate. Thecore rod 66 is arranged to facilitate the formation of the flexibleinner tube 64 by filament winding and to enhance the twist control when rotating the flexibleinner tube 64 and thecore rod 66.
As shown in fig. 2 and 10, thescrew driver 62 is rotatably connected to theouter sleeve member 80, and the rotation of thescrew driver 62 relative to theouter sleeve member 80 can drive thepush rod 42 to move axially. Specifically, theouter sheath assembly 80 further includes a connectingcylinder 82, asleeve 86 disposed outside thecollet 22 and thepush rod assembly 40 and fixedly connected to a distal end of the connectingcylinder 82, and anend cap 88 covering a distal end of thesleeve 86. The distal end of theouter tube 84 is fixedly connected to the proximal end of theconnector barrel 82, the proximal end of theouter tube 84 is fixedly connected to the distal end of thehandle 90, the lumen of theouter tube 84 communicates with the lumen of theconnector barrel 82, and theconnector barrel 82 is threadedly connected to the threadeddrive member 62. Thecollet 22 and thepush rod assembly 40 are contained within thesleeve 86, and thecollet 22 is fixedly coupled to thesleeve 86 such that the axial position of thecollet 22 is fixed. Thescrew driving member 62 is rotatably inserted into the connectingcylinder 82, and specifically, thescrew driving member 62 and the connectingcylinder 82 are driven by screw fit. In this embodiment, an inner circumferential surface of the connectingcylinder 82 is provided with an inner thread, thescrew transmission member 62 is a transmission screw rod matched with the inner thread, a distal end of thescrew transmission member 62 is fixedly connected with a connectingmember 67, the connectingmember 67 is rotatably connected with thepush rod assembly 40, and thescrew transmission member 62 synchronously rotates and axially moves to drive thepush rod assembly 40 to axially move. In this embodiment, the internal thread of the connectingcylinder 82 is a triangular thread, and the transmission screw rod is provided with a triangular thread matching the internal thread of the connectingcylinder 82. Of course, the internal threads of the connectingcylinder 82 and the external threads on the drive screw rod may also be saw-tooth threads, rectangular threads, trapezoidal threads, etc.
Referring to fig. 10 and 26 to 31, thesleeve 86 is a hollow tube, the proximal end of thesleeve 86 is provided with a snap ring groove around the inner cavity thereof, and the distal end of the connectingcylinder 82 is fixedly connected to the snap ring groove of thesleeve 86; the distal end of thesleeve 86 projects distally around its lumen with a snap ring for securing anend cap 88. The peripheral wall of thesleeve 86 is provided with athreading slot 860 near thecollet 22, and thethreading slot 860 is used for threading out a suture thread which is threaded in thelock nail 300.
The distal end of theend cap 88 defines a suture access opening 880 in communication with the interior cavity of thesleeve 86, and thelocking pin 300 can be inserted into the interior cavity of thesleeve 86 through thesuture access opening 880. Specifically, theend cap 88 includes acircular cover plate 881 and anannular coupling plate 883 disposed about a periphery of thecover plate 881, thecoupling plate 883 coupling the distal end of thesleeve 86, and thesuture inlet 880 opening axially in a central portion of thecover plate 881.
Referring to fig. 11 and 12, thethreading cavity 301 of the lockingnail 300 is axially inserted through the two opposite ends of the lockingnail 300, and thethreading cavity 301 is used for accommodating and passing the suture. Thelocking pin 300 can be collapsed when subjected to mechanical external forces to secure the suture in thethreading lumen 301 of thelocking pin 300. Thelocking pin 300 may be of various shapes, e.g., cylindrical, prismatic, oval, etc., so long as it has a threadedcavity 301 for receiving a suture. In this embodiment, the lockingpin 300 is formed in a hollow cylindrical shape to reduce the resistance to pressure and to prevent scratching of human tissue. The outer wall of the distal end of the lockingnail 300 is radially and convexly provided with anannular round platform 303, the near end edge and the distal end edge of the outer peripheral surface of theround platform 303 are both provided with chamfers so as to avoid scratching internal tissues of a patient body, and preferably, the near end edge and the distal end edge of the outer peripheral surface of theround platform 303 are both rounded. The distal opening of thethreading lumen 301 of the lockingnail 300 smoothly transitions with the distal surface of the lockingnail 300 to avoid the junction therebetween cutting the suture or scratching the internal tissue of the patient. Thelocking pin 300 is made of a biocompatible material such as stainless steel, pure titanium, nickel titanium, cobalt chromium alloy, and preferably pure titanium or stainless steel.
In other embodiments, in order to improve the coupling force between thecrimped nail 300 and the suture, at least one pair of interlocking structures may be disposed in thethreading cavity 301 of thenail 300, for example, a convex locking platform and a concave locking hole may be disposed at two positions opposite to thethreading cavity 301, when thenail 300 is subjected to external crimping force and begins to deform, the convex locking platform is pressed into the concave locking hole, and when thenail 300 continues to deform, the locking platform and the locking hole are simultaneously deformed until they cannot be separated, and at this time, the suture is firmly fixed in thethreading cavity 301 of thenail 300.
In order to improve the coupling force between thecrimped lock pin 300 and the suture, an anti-slip structure may be further provided on the inner circumferential surface of thethreading cavity 301, for example, an anti-slip pattern or a roughening treatment may be provided on the inner circumferential surface of thethreading cavity 301, so that after thelock pin 300 is deformed by external crimping force, the friction force between the suture and the inner circumferential surface of thethreading cavity 301 is increased, and the suture is more firmly fixed in thethreading cavity 301 of thelock pin 300.
Referring to fig. 10 and 13, thecollet 22 includes afirst collet 221 and asecond collet 223 formed integrally and disposed opposite to each other, and agap 25 is formed between thefirst collet 221 and thesecond collet 223. When the drivingmember 70 drives thescrew driving member 62 to rotate, because the connectingcylinder 82 is fixed in position, thescrew driving member 62 rotates and moves axially to push thepush rod 42 to move axially, i.e. the rotation of thescrew driving member 62 is converted into the axial movement of thepush rod 42, so that thepush rod 42 pushes thefirst chuck 221 and thesecond chuck 223 of thechuck 22 to move closer to each other, and thefirst chuck 221 and thesecond chuck 223 can press the lockingnail 300 to deform the lockingnail 300 to lock the suture.
In this embodiment, thefirst collet 221 and thesecond collet 223 are integrally formed by an elastic hard material, and when thepush rod 42 moves toward the proximal end in the axial direction to slidably push thefirst collet 221, thefirst collet 221 elastically deforms and moves toward thesecond collet 223 to press the lockingpin 300. The proximal end of thecollet 22 is closed and apin 24 is disposed perpendicular to the axial direction through the proximal end of thecollet 22, with opposite ends of thepin 24 secured to thesleeve 86. Specifically, thepin 24 is inserted into the proximal end of thegap 25, and the two opposite ends of thepin 24 are respectively and fixedly connected to thesleeves 86; thesleeve 86 is provided with two opposite connecting holes along the radial direction, two opposite ends of thepin 24 are fixedly inserted into the two connecting holes respectively, and thepin 24 positions thechuck 22 to prevent thechuck 22 from moving along the axial direction.
As shown in fig. 13, the first andsecond collets 221 and 223 are disposed in spaced-apart opposition and have their proximal ends connected to each other. Agap 25 is defined between thefirst clamping head 221 and thesecond clamping head 223, apin hole 2211 is formed in thegap 25 adjacent to the connection position of thefirst clamping head 221 and thesecond clamping head 223, thepin 24 is inserted into thepin hole 2211, and preferably, the central angle corresponding to thepin hole 2211 is greater than 180 degrees so as to prevent the clampinghead 22 from moving towards the near end or the far end along the axial direction. The side of thefirst clamping head 221 facing away from thesecond clamping head 223 is provided with an inclinedslide guiding surface 2213, and theslide guiding surface 2213 is located at the distal end of thefirst clamping head 221 and extends obliquely towards the side far away from thegap 25. Specifically, the distal end of thefirst collet 221 is provided with a protrusion protruding into thegap 25, the side of the protrusion facing thesecond collet 223 is provided with afirst clamping tooth 2215, specifically, thefirst clamping tooth 2215 is located at the distal end of the side of thefirst collet 221 facing thesecond collet 223, and thefirst clamping tooth 2215 comprises a plurality of tooth grooves, each tooth groove extends along a direction substantially perpendicular to the axial direction.
The side of thesecond collet 223 facing thefirst collet 221 adjacent the distal end is provided withsecond clamping teeth 2235, in particular, thesecond clamping teeth 2235 are located adjacent the distal end on the side of thesecond collet 223 facing thegap 25, thesecond clamping teeth 2235 include a plurality of gullets, and each gullet of thesecond clamping teeth 2235 extends in the same direction as the gullet of thefirst clamping teeth 2215. When the first andsecond cartridges 221 and 223 are moved toward each other, the first and secondgripping teeth 2215 and 2235 of the first andsecond cartridges 221 and 223 are misaligned and engaged with each other, so that thefirst cartridge 221 is elastically deformed toward thesecond cartridge 223, and the first and secondgripping teeth 2215 and 2235 press the lockingpin 300 placed in thegap 25 into a shape having a curvature. The proximal end of the side of thesecond cartridge 223 facing away from thefirst cartridge 221 is provided with a guide-slide surface 2236 parallel to the axial direction. Specifically, the slidingguide surface 2236 is provided with athreading hole 2237 communicating with thegap 25, and thethreading hole 2237 is adjacent to the proximal end of thesecond clamping tooth 2235, so that the suture thread passing through the lockingnail 300 can pass through thethreading hole 2237. Apositioning block 2233 is convexly arranged at the far end of the side surface of thesecond chuck 223 departing from thefirst chuck 221, the near end surface of thepositioning block 2233 is close to thethreading hole 2237, and the near end surface of thepositioning block 2233 is atangential surface 2238.
In other embodiments, the proximal surface of thepositioning block 2233 defines cutting slots that extend through opposing sides of thesecond collet 223 in a direction perpendicular to the axial direction.
Referring to fig. 10, 14-15 and 26-31, thepush rod assembly 40 further includes a base 44 coaxial with thescrew transmission member 62 and atangential blade 46 fixedly connected to thebase 44, and thepush rod 42 is fixedly connected to thebase 44 and extends in the axial direction; the connectingpiece 67 is rotatably connected with thebase 44, and an axial limiting structure is arranged between the connectingpiece 67 and thebase 44. Thecutting blade 46 is spaced apart from and opposite thepush rod 42, and thecutting blade 46 is axially slidable against theslide guide surface 2236. Thebase 44 is axially slidably received within thesleeve 86. Thebase 44 is axially slidably received in thesleeve 86, and thepush rod 42 axially slidably abuts against the guide-slide surface 2213 of thefirst cartridge 221. In this embodiment, thebase 44 is a cylindrical rod, and thetangent blade 46 is fixedly connected to the base 44 at the opposite side of thepush rod 42. A steppedhole 440 is axially formed in the middle of thebase 44, two opposite ends of the steppedhole 440 respectively penetrate through the proximal end face and the distal end face of thebase 44, and the steppedhole 440 includes alarge hole 441 located at the distal end of thebase 44 and asmall hole 443 located at the distal end of thebase 44; thepedestal 44 forms astep surface 445 between thelarge hole 441 and thesmall hole 443. The outer peripheral wall of thebase 44 is provided with two fixing grooves 446 at opposite sides of the steppedhole 440, and the proximal end of thepush rod 42 and the proximal end of thetangent blade 46 are fixed to the two fixing grooves 446, respectively.
The end of thepush rod 42 facing thetangent blade 46 away from thebase 44 is provided with an arc-shaped slide-assistingsurface 420, and the slide-assistingsurface 420 is used for slidably abutting against the slide-guidingsurface 2213 of thefirst clamping head 221. The distal end of thepush rod 42 is provided with anabutting block 421, and theabutting block 421 is used for pressing the deformation of the lockingnail 300 when abutting against thechuck 22, specifically, one end of thepush rod 42 away from thebase 44 is provided with theabutting block 421 in a protruding manner toward one side of thecutting blade 46, the sliding assistingsurface 420 is arranged on the side surface of theabutting block 421 facing thecutting blade 46, and the distal end of thecutting blade 46 is provided with acutting edge 461. In this embodiment, the outer side of thepushrod 42 is coplanar with the outer side of thepedestal 44; the outer side of thetangent blade 46 is coplanar with the outer side of thebase 44. During the process of elastically deforming thecollet 22 to press the lockingnail 300 to be deformed to lock the suture, thethread cutting blade 46 slides against the slidingguide surface 2236 of thecollet 22 until theblade 461 presses against thethread cutting surface 2238 to cut the suture passing through thethreading hole 2237.
Referring to fig. 2 and 16-17, the connectingmember 67 is connected between the distal end of thescrew drive member 62 and thepush rod assembly 40; thescrew transmission member 62 includes atransmission screw 621 located at a distal end and a connectingportion 623 disposed at a proximal end of thetransmission screw 621, and thetransmission screw 621 is screwed to the internal thread of the connectingcylinder 82. The middle part of the distal end surface of thetransmission screw 621 is provided with apositioning hole 624 along the axial direction, the proximal end surface of the connectingportion 623 is provided with a connectinghole 626, the distal end of the flexibleinner tube 64 is fixedly connected in the connectinghole 626 of thescrew transmission element 62, the proximal end of the flexibleinner tube 64 is fixedly connected to the drivingelement 70, and the drivingelement 70 is used for driving the flexibleinner tube 64 and thescrew transmission element 62 to rotate.
In this embodiment, the connectingmember 67 is a connecting pin, and the connectingmember 67 includes a connectingrod 672 inserted into thesmall hole 443 and thepositioning hole 624 of the steppedhole 440, and astopper 674 disposed at a distal end of the connectingrod 672 and received in thelarge hole 441 of the steppedhole 440. The connectingrod 672 is fixedly connected to thepositioning hole 624, the connectingrod 672 is rotatably inserted into thesmall hole 443, thestopper 674 is rotatably accommodated in thelarge hole 441, and thestopper 674 is stopped on thestep surface 445. The axial limiting structure between the connectingmember 67 and thebase 44 refers to the steppedhole 440 and thestopper 674. Thedrive screw 621 rotates and moves axially to rotate the connectingmember 67 in the steppedhole 440, and simultaneously the distal end of thedrive screw 621 pushes thepush rod assembly 40 to move axially toward the distal end, or thestopper 674 pulls thepush rod assembly 40 to move axially toward the proximal end.
In other embodiments, thescrew drive 62 is a drive screw, but thescrew drive 62 is directly threaded into the base 44 (not shown), and the axial position of thescrew drive 62 relative to thesleeve 86 is fixed, and thescrew drive 62 is only rotated to drive thepush rod assembly 40 to move axially, and specifically, a limit structure, such as a matching groove and flange, may be provided between thescrew drive 62 and the proximal end of thesleeve 86 to limit the axial movement of thescrew drive 62 but allow thescrew drive 62 to rotate.
As shown in fig. 2 and 16, the drivingmember 70 is connected to the proximal end of thetransmission assembly 60, specifically, the drivingmember 70 is a rotating member rotatably disposed at the proximal end of thehandle 90, and the proximal ends of the flexibleinner tube 64 and thecore rod 66 are fixedly connected to the drivingmember 70. The middle part of the far end surface of the drivingelement 70 is provided with arotating shaft 72 in a protruding mode along the axial direction, the edge of the far end surface of the drivingelement 70 is provided with anannular flange 74 along the axial direction, the extending length of therotating shaft 72 is larger than that of theflange 74, and an annularaccommodating groove 75 is defined between therotating shaft 72 and theflange 74. The drivingmember 70 has a central portion with a throughhole 76 formed therein, the throughhole 76 being located at the central portion of therotating shaft 72, the throughhole 76 being adapted to receive the flexibleinner tube 64 and the proximal end of thecore rod 66. The proximal end face of the drivingmember 70 is provided with apositioning hole 77 around the throughhole 76, apositioning block 78 is fixed in thepositioning hole 77, the proximal ends of the flexibleinner tube 64 and thecore rod 66 penetrate through the throughhole 76 and then are fixedly connected to thepositioning block 78, thepositioning block 78 is preferably a square block, and the rotation of the drivingmember 70 drives the flexibleinner tube 64 and thecore rod 66 to rotate together through thepositioning block 78. The outer wall of the drivingmember 70 is provided with ananti-slip mechanism 79, and the drivingmember 70 can be conveniently rotated by holding theanti-slip mechanism 79 by hand.
Referring to fig. 1-2 and 18-20, the drivingmember 70 is rotatably connected to the proximal end of thehandle 90, thehandle 90 is axially provided with a throughslot 910, and the flexibleinner tube 64 and the proximal end of thecore rod 66 are fixedly connected to the drivingmember 70 through the throughslot 910. Thehandle 90 includes ahousing 91 and aguide rod 96 fixedly inserted into thehousing 91, wherein theguide rod 96 is used for positioning the flexibleinner tube 64. In this embodiment, the cross section of thehousing 91 is a polygonal rod-shaped structure, arotation hole 93 is formed around the throughslot 910 on the proximal end surface of thehousing 91, therotation hole 93 is used for rotatably connecting the distal end of the drivingmember 70, and specifically, therotation shaft 72 of the drivingmember 70 is rotatably inserted into therotation hole 93. The distal end face of thehandle 90 is provided with apositioning hole 95 around the throughgroove 910, theguide rod 96 is inserted into thepositioning hole 95, theguide rod 96 is provided with aguide groove 962 along the axial direction, the proximal end of the flexibleinner tube 64 is movably accommodated in theguide groove 962, and the proximal end of the flexibleinner tube 64 is prevented from being twisted and warped when rotating. The distal end of theguide 96 is provided with acover plate 964. A connectingpipe 966 is convexly arranged in the middle of the distal end face of thecover plate 964, theguide groove 962 is communicated with the inner cavity of the connectingpipe 966 after penetrating through thecover plate 964, and the proximal end of the flexibleinner pipe 64 is connected to the drivingmember 70 after penetrating through the connectingpipe 966, theguide groove 962 and the throughgroove 910; the proximal end of theouter tube 84 is fixedly connected to a connectingtube 966. The proximal end of the outer peripheral wall of theguide rod 96 is provided with at least one fixinghole 967, the outer peripheral wall of thehousing 91 is provided with a connectinghole 913 communicated with thepositioning hole 95, when theguide rod 96 is inserted into thepositioning hole 95, thecover plate 964 covers the distal end surface of thehousing 91, the fixinghole 967 of theguide rod 96 corresponds to the connectinghole 913 of thehousing 91, and the locking rod is inserted into the connectinghole 913 and the fixinghole 967, so that theguide rod 96 is fixedly connected with thehousing 91. In other embodiments, the cross-section of thehousing 91 may be a rod-like structure with a circular, oval, rectangular or irregular shape.
Referring to fig. 21 and 22, at least onelength scale 915 is axially disposed on thehandle 90 adjacent to the drivingmember 70, and the at least onelength scale 915 is used for displaying the displacement amount of the drivingmember 70 moving in the axial direction. Specifically, the proximal end of the outer peripheral surface of thehousing 91 is provided with a plurality of length scales 915, and the plurality of length scales 915 are arranged in a circle along the circumferential direction of thehousing 91 to facilitate observation of the displacement amount of the drivingmember 70 moving in the axial direction. When the distal face offlange 74 ofdriver 70 is aligned with 0 onlength scale 915, first andsecond collets 221 and 223 ofcollet 22 are in a fully open state, and pushrod 42 does not apply axial thrust tocollet 22; when the drivingmember 70 rotates and moves axially until the distal end surface of theflange 74 is aligned with a certain scale value, such as 5, on thelength scale 915, thepush rod 42 pushes thecollet 22, and thefirst collet 221 and thesecond collet 223 of thecollet 22 press the lockingnail 300 to deform and fix the suture thread passing through the lockingnail 300. The above-mentioned certain scale value refers to the scale value of thefirst clamping head 221 and thesecond clamping head 223 pressing the lockingnail 300 to deform so as to realize that the lockingnail 300 firmly fixes the suture line, and the certain scale value can be set according to the actual requirement. The drivingmember 70 rotates to drive the flexibleinner tube 64 and thescrew driving member 62 to rotate, thescrew driving member 62 is screwed to the inner thread of the connectingcylinder 82, and the connectingcylinder 82 is fixed in the axial position, so that thescrew driving member 62 rotates and moves axially, and thepush rod 42, the flexibleinner tube 64 and the drivingmember 70 move axially therewith, when the drivingmember 70 moves axially until the distal end surface of theflange 74 faces the certain scale, thechuck 22 has pressed the lockingnail 300 to deform and fix the suture thread passing through the lockingnail 300, and at this time, the rotation of the drivingmember 70 can be stopped. The outer peripheral surface of thehandle 90 is provided with ananti-slip mechanism 917 for easy gripping.
Referring to fig. 1, 2, 10 and 19-22, when the locking device 100 is assembled, the guide rod 96 is inserted into the positioning hole 95 of the handle 90, such that the guide slot 962 faces the through slot 910, the fixing hole 967 faces the connecting hole 913, and the locking rod is inserted into the connecting hole 913 and the fixing hole 967; the rotating shaft 72 of the driving member 70 is rotatably inserted into the rotating hole 93 of the handle 90; the proximal ends of the flexible inner tube 64 and the core rod 66 sequentially pass through the connecting tube 966, the guide groove 962, the through groove 910 and the through hole 76 and then are fixed in the positioning hole 77 of the driving member 70 through the positioning block 78; the distal ends of the flexible inner tube 64 and the core rod 66 are fixed to the connecting hole 626 of the screw driver 62, the outer tube 84 is sleeved outside the screw driver 62 and the flexible inner tube 64, and the proximal end of the outer tube 84 is fixedly connected to the connecting tube 966 of the guide rod 96; after the driving screw 621 of the screw driver 62 is screwed into the internal thread of the connecting cylinder 82, the distal end of the outer tube 84 is fixedly connected to the proximal end of the sleeve 86 through the connecting cylinder 82; placing the push rod assembly 40 at the distal end of the connecting cylinder 82 so that the proximal end face of the push rod assembly 40 faces the distal end face of the connecting cylinder 82, inserting the connecting rod 672 of the connecting member 67 into the stepped hole 440 of the base 44 and then fixedly connecting the connecting rod 672 to the positioning hole 624 of the screw driver 62; securing the collet 22 to the distal end of the sleeve 86 such that the threadable bore 2237 of the second collet 223 is aligned with the threadable slot 860 of the sleeve 86 and the opposite ends of the pin 24 are secured to the sleeve 86; sleeving the sleeve 86 outside the push rod assembly 40, wherein the proximal end of the sleeve 86 is fixedly connected to the distal end of the connecting cylinder 82, so that the collet 22 is located between the push rod 42 and the tangent blade 46, the push rod 42 contacts the first collet 221, and the cutting edge 461 of the tangent blade 46 faces the tangent plane 2238; the end cap 88 is then placed over the distal end of the sleeve 86 such that the proximal end of the end cap 88 is fixedly attached to the distal end of the sleeve 86 and the suture inlet 880 of the end cap 88 is positioned over the void 25.
Referring to fig. 23 to 32, the procedure of using theinterventional locking device 100 of the present invention is described below by taking a valve repair of a tricuspid valve as an example.
The tricuspid valve is a one-way "valve" between the Right Atrium (RA) and the Right Ventricle (RV), which ensures blood flow from the right atrium to the right ventricle. A normal healthy tricuspid valve has a plurality of chordae tendineae. The valve leaves of the tricuspid valve are divided into an anterior leaf, a posterior leaf and a septal lobe, when the right ventricle is in a diastole state, the three are in an open state, and blood flows from the right atrium to the right ventricle; when the right ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior leaflet, the posterior leaflet and the septal leaflet are well closed, thereby ensuring that blood flows from the right ventricle to the pulmonary artery through the Pulmonary Valve (PV). If the tricuspid valve is diseased, when the right ventricle is in a contracted state, the tricuspid valve cannot be restored to a completely closed state as in a normal state, but an incomplete closing phenomenon occurs, and the impulse of blood flow further causes the valve leaflets to fall into the right atrium, so that blood backflow is caused. To tricuspid valve regurgitation, can adopt the intervention mode to implant the stylolite to each leaflet, then use the utility model provides a lock knot device is in the same place the seam on each leaflet and line lock knot to implement reason to reason and repair, specific process is as follows:
the first step is as follows: as shown in fig. 23, firstly, one ormore sutures 500 withelastic spacers 501 are implanted into the anterior leaflet, the posterior leaflet and the septal leaflet of the tricuspid valve of a patient, and the point contact between thesutures 500 and the leaflets is converted into the surface contact between theelastic spacers 501 and the leaflets, so that the risk of tearing the leaflets can be effectively reduced;
the second step is that: as shown in fig. 24, 26 and 29, a plurality ofsutures 500 on three valve leaflets are all threaded into thethreading cavity 301 of the lockingnail 300 outside the patient body, and the proximal ends of thesutures 500 are sequentially threaded through thethreading cavity 301 of the lockingnail 300, thegap 25 between thefirst clamping head 221 and thesecond clamping head 223 and thethreading hole 2237 and then pass out of the threadinggroove 860 of thesleeve 86;
the third step: advancing the distal end of theinterventional locking device 100 through the femoral vein into the right atrium of the heart by means of a bending sheath (not shown), moving closer to the leaflets of the tricuspid valve while pulling thesuture 500 until the distal end of thelocking device 100 reaches a predetermined position in the right atrium;
the fourth step: adjusting the tightness of the threeleaflet sutures 500 of the anterior, posterior and septal leaflets, respectively, while determining the state of the tricuspid valve with the lightest regurgitation by ultrasound, and when this state is reached, stopping adjusting and maintaining the tightness of the three sets ofsutures 500, i.e. maintaining the relative positions between the anterior, posterior and septal leaflets of the tricuspid valve;
the fifth step: as shown in fig. 27 and fig. 30, the driving member 70 on the handle 90 is rotated, the flexible inner tube 64 and the screw driving member 62 are rotated by the rotation of the driving member 70, the flexible inner tube 64 and the screw driving member 62, because the screw driving member 62 is screwed into the inner thread of the connecting cylinder 82, and the connecting cylinder 82 is fixed in the axial position, so that the screw driving member 62 rotates together and moves axially, thereby driving the driving member 70, the flexible inner tube 64 and the screw driving member 62 to move axially and distally, the screw driving member 62 pushes the push rod assembly 40 to move axially and distally, the push rod 42 moves distally relative to the collet 22, the sliding-assisting surface 420 of the push rod 42 continuously presses the sliding-guiding surface 2213 on the collet 22, so that the first collet 221 of the collet 22 approaches the second collet 223, the first gripping tooth 2215 and the second gripping tooth 2235 press the locking nail 300 accommodated in the gap 25 until the locking nail 300 deforms, and the three groups of sutures 500 in the locking nail 300 are locked together, meanwhile, the cutting edge 461 of the cutting blade 46 abuts against the cutting surface 2238 of the second collet 223, the cutting blade 46 smoothly cuts the three groups of sutures 500 at the proximal side of the locking nail 300, and then the three groups of redundant sutures 500 are drawn out of the patient;
and a sixth step: as shown in fig. 25, 28, 31 and 32, the drivingmember 70 on the driving handle 90 is rotated in opposite directions, and the opposite rotation of the drivingmember 70 rotates the flexibleinner tube 64 and the threaded drivingmember 62 in opposite directions, so that the drivingmember 70, the flexibleinner tube 64 and the threaded drivingmember 62 move axially and proximally, and the threaded drivingmember 62 pulls thepush rod assembly 40 axially and proximally through the connectingmember 67; during axial proximal movement ofpush rod assembly 40, slide-aid surface 420 ofpush rod 42 continues to release the compressive force from slide-guide surface 2213 oncollet 22 untilcollet 22 is resilient to the initial position by its own spring force. Thedeformed locking pin 300 is released from the distal end of thesheath member 80 from thespace 25 of thecollet 22, and separated from thelocking device 100;
the seventh step: the distal end of theknotting device 100 is withdrawn from the patient and thestaples 300 are left in the patient, at which time thestaples 300 secure together three sets ofsutures 500 that are passed through the anterior, posterior and septal leaflets, respectively, and the anterior, posterior and septal leaflets of the tricuspid valve are repaired.
It can be understood that, the above description only uses the intervention type locking device for performing the intervention type tricuspid valve repair process as an example to illustrate the use process thereof, and the intervention type locking device of the present invention can also be used for locking and fixing the suture thread in other intervention type operation processes.
The utility model discloses an interventionformula keying device 100 is particularly useful for following scene, if:
performing an interventional mitral valve repair procedure via a path of femoral vein-right atrium-interatrial septum-left atrium-mitral valve;
performing an interventional mitral valve repair procedure via a femoral artery-aortic arch-aortic valve-left ventricle-mitral valve pathway;
interventional mitral valve repair procedures are performed via the jugular vein-right atrium-interatrial septum-left atrium-mitral valve pathway.
The following scenario applies as well: interventional tricuspid valve repair surgery is performed via the jugular vein-right atrium-tricuspid valve approach. By way of minimally invasive intervention, manipulation of theinterventional locking device 100 outside the patient's body secures thesuture 500 implanted on the leaflets by the lockingstaples 300.
In other embodiments, thepushrod assembly 40 is connected to thesleeve 86 by axially extending guide slots and bars to ensure that thepushrod assembly 40 only slides axially within thesleeve 86 without rotating; specifically, the outer wall of thepush rod 42 is provided with a guide bar extending along the axial direction, and the inner circumferential surface of thesleeve 86 is provided with a guide groove corresponding to the guide bar; alternatively, the outer wall of thepush rod 42 is provided with a guide groove extending along the axial direction, and the inner circumferential surface of thesleeve 86 is provided with a guide bar corresponding to the guide groove, and the guide bar can slide along the axial direction in the guide groove.
Referring to fig. 33 to 35, the structure of the intervention type locking device according to the second embodiment of the present invention is similar to that of the first embodiment, except that: the structure of the flexibleinner tube 64a in the second embodiment is different from that of the flexibleinner tube 64 in the first embodiment. Specifically, in this embodiment, the flexibleinner tube 64a has a similar structure to theouter tube 84, and a plurality ofsecond slot units 641 are cut on the wall of the hard tube by using a laser cutting device to obtain the flexible property.
Specifically, eachsecond slot unit 641 includes Mslots 642 axially spaced apart from each other and penetrating the wall of the flexibleinner tube 64a, M being a positive integer greater than or equal to 2, and the flexibleinner tube 64a has flexibility in a portion corresponding to eachslot 642 and rigidity in a portion corresponding to a space between each adjacent twoslots 642. In this embodiment, the value of M is 4, in other embodiments, the value of M may also be 2, 3, 5, 6, etc., and the larger the value of N, the better the flexibility of the flexibleinner tube 64 a. The structure of eachslot 642, the relationship between twoadjacent slots 642, etc. are the same as the corresponding structure and relationship on theouter tube 84, and will not be described herein again.
Referring to fig. 36 to 38, a third embodiment of the present invention provides an insertion type locking device having a structure similar to that of the first embodiment, except that: the structure of the flexibleinner tube 64d in the third embodiment is slightly different from that of the flexibleinner tube 64 in the first embodiment, and specifically, the flexibleinner tube 64d is a hollow tubular flexible tube body having a certain torsion resistance and formed by spirally winding a plurality of filaments. Parameters of the hollow tubular flexible pipe body: the number of the wire groups is 3 to 6, the diameter of the wire is 0.3 to 0.75mm, the pitch of the wire is 0.3 to 0.8mm, the gap of the wire is 0 to 0.15mm, the two opposite ends of the hollow tubular flexible pipe body are respectively provided with ametal sleeve 645, and themetal sleeves 645 can be directly welded to the two opposite ends of the hollow tubular flexible pipe body respectively by adopting equipment. In the embodiment, the hollow flexibleinner tube 64d is formed by tightly winding 6 groups of wires, the flexibleinner tube 64d with the structure has better flexibility, and the weight of the instrument can be properly reduced under the condition of ensuring enough torsion resistance. The proximal end of flexibleinner tube 64d is fixedly attached topositioning block 78 after passing throughbore 76, and the distal end of flexibleinner tube 64d is fixed to the proximal end of threadeddrive element 62 after passing throughouter tube 84.
Referring to fig. 39 to 41, the structure of the intervention type locking device according to the fourth embodiment of the present invention is similar to that of the first embodiment, except that: the structure of the flexibleinner tube 64e in the fourth embodiment is different from that of the flexibleinner tube 64 in the first embodiment, and specifically, the flexibleinner tube 64e in this embodiment includes a plurality ofhinge cylinders 646, twoadjacent hinge cylinders 646 are connected in a nesting manner, and the plurality ofhinge cylinders 646 are connected to form the flexibleinner tube 64e, and the flexibleinner tube 64e can be bent toward two opposite sides of the nesting portion. The proximal end of flexibleinner tube 64e is fixedly attached topositioning block 78 after passing throughbore 76, and the distal end of flexibleinner tube 64e is fixedly attached to the proximal end of threadeddrive element 62 after passing throughouter tube 84.
Specifically, one end of eachhinge cylinder 646 is protruded with twoopposite engagement pieces 6461, and the other end of eachhinge cylinder 646 is opened with twoopposite connection ports 6463. In twoadjacent hinge cylinders 64, twoengagement pieces 6461 of onehinge cylinder 646 are respectively nested in twoconnection ports 6463 of theother hinge cylinder 646, and an axial gap is formed between the twoadjacent hinge cylinders 64 on both sides of the hinge portion to facilitate bending of the flexibleinner tube 64 e. Theattachment opening 6463 of eachhinge barrel 646 is a generally C-shaped opening, and theengagement tabs 6461 of eachhinge barrel 646 are circular-like tabs that nest with thecorresponding attachment opening 6463.
The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (16)

1. An intervention type locking device is characterized by comprising a chuck, a push rod assembly arranged outside the chuck, a transmission assembly connected with the push rod assembly, and an outer sleeve assembly sleeved outside the chuck, the push rod assembly and the transmission assembly; the push rod assembly comprises a push rod arranged outside the chuck; the axial position of the chuck is fixed and the chuck has elasticity, when in an initial state, the chuck accommodates a locking nail with a suture line, and the part of the chuck close to the push rod is gradually inclined outwards from the near end to the far end; the transmission assembly drives the push rod assembly to move axially, so that the push rod abuts against the chuck to force the chuck to press the locking nail to deform so as to lock a suture thread penetrating through the locking nail; the outer sleeve component comprises a hard outer pipe sleeved outside the transmission component, and a plurality of first slot units are arranged on the pipe wall of the outer pipe in the axial direction.
CN201922393431.XU2019-12-262019-12-26Insertion type locking deviceActiveCN211934163U (en)

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CN201922393431.XUCN211934163U (en)2019-12-262019-12-26Insertion type locking device
PCT/CN2020/120853WO2021129058A1 (en)2019-12-262020-10-14Interventional locking device

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
CN112675422A (en)*2020-12-162021-04-20杭州诺茂医疗科技有限公司Hypotube, sheath subassembly and remove device
CN113040844A (en)*2019-12-262021-06-29杭州德晋医疗科技有限公司Insertion type locking device
CN113576568A (en)*2021-07-262021-11-02二零二零(北京)医疗科技有限公司Visual knot pusher

Cited By (5)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
CN113040844A (en)*2019-12-262021-06-29杭州德晋医疗科技有限公司Insertion type locking device
CN113040844B (en)*2019-12-262024-08-16杭州德晋医疗科技有限公司Insertion type locking device
CN112675422A (en)*2020-12-162021-04-20杭州诺茂医疗科技有限公司Hypotube, sheath subassembly and remove device
CN112675422B (en)*2020-12-162024-06-28杭州德诺电生理医疗科技有限公司 Hypotubes, sheath assemblies, and retrieval devices
CN113576568A (en)*2021-07-262021-11-02二零二零(北京)医疗科技有限公司Visual knot pusher

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