CN113974776B - Pusher and thrombus aspiration system comprising same - Google Patents
Pusher and thrombus aspiration system comprising same Download PDFInfo
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- CN113974776B CN113974776B CN202111360924.9A CN202111360924A CN113974776B CN 113974776 B CN113974776 B CN 113974776B CN 202111360924 A CN202111360924 A CN 202111360924A CN 113974776 B CN113974776 B CN 113974776B
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Abstract
The invention provides a pusher and a thrombus aspiration system comprising the same. The system comprises: suction sheath, sheath positioning stent and pusher. The suction sheath comprises a sheath body, and a sheath positioning support is arranged at the distal end of the sheath body; the sheath positioning bracket is a self-expanding bracket structure with two open ends. The pusher includes: push head, push rod and drive assembly. The pusher head has an annular cavity open to the proximal end for receiving the sheath positioning stent in a compressed state. The distal end of the pushing rod is connected with the proximal end of the pushing head, and the pushing rod and the pushing head can be arranged on the suction sheath tube in a penetrating way and can move axially relative to the suction sheath tube. A drive assembly is coupled to the push rod and is configured to drive the push rod distally within the suction sheath to release the sheath positioning stent. According to the embodiment of the invention, the suction sheath tube is centered to suck under the supporting action of the sheath tube positioning bracket, the suction port can be enlarged, the suction efficiency is improved, the blood loss is reduced, and meanwhile, the operation is convenient.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a pusher and a thrombus aspiration system comprising the same.
Background
Vascular diseases become an important factor affecting human health, and interventional thrombolysis is a research hotspot in the current thrombus treatment field.
Aspiration plugs are becoming more common in clinical applications in recent years, but due to the complexity of the anatomy of blood vessels, current aspiration catheters often cling to a side of a blood vessel wall during aspiration, the aspiration effect is poor, the blood loss during aspiration is large, and the risk of damaging the blood vessel wall is increased.
Disclosure of Invention
The embodiment of the invention aims to provide a pusher and a thrombus aspiration system comprising the same, so as to solve the problems of low aspiration efficiency, large blood loss and easiness in damaging a blood vessel wall.
In order to solve the technical problems, according to one aspect of the present invention, an embodiment of the present invention provides a pusher, which can be inserted into a suction sheath, wherein a sheath positioning bracket is disposed at a distal end of the suction sheath; the pusher is used for conveying and releasing the sheath positioning bracket; the pusher comprises: a pusher head having an annular cavity open to a proximal end for receiving the sheath positioning stent in a compressed state; the distal end of the pushing rod is connected with the proximal end of the pushing head, and the pushing rod and the pushing head can be arranged on the suction sheath tube in a penetrating way and can axially move relative to the suction sheath tube; and the distal end of the driving component is connected with the proximal end of the suction sheath, and the driving component is fixedly connected with the pushing rod and is used for driving the pushing rod to move distally in the suction sheath so as to release the sheath positioning bracket.
In addition, the driving assembly includes: the pushing handle is of a tubular structure, the pushing rod penetrates through the pushing handle, and the pushing handle is provided with a sliding lock mechanism; and the push button is fixedly connected with the push rod and matched with the sliding lock mechanism, the push button is used for driving the push rod to axially move relative to the push handle, and the sliding lock mechanism can lock the push button on the push handle.
In addition, the push handle includes: the handle connector is used for connecting the pusher to the proximal end of the sheath tube sealing device; the slide lock mechanism includes: the elastic locking piece is provided with two groups of racks which are symmetrically arranged; each group of racks respectively comprises a plurality of saw teeth which are uniformly distributed along the axial direction; the push button includes two operation parts of symmetry setting, the outer end of operation part exposes respectively the spout, the inner of operation part includes: and the fixed part is connected with the pushing rod and is propped against the locking head of the rack.
In addition, the distal end of the pushing head is tapered.
According to a second aspect of the present invention, an embodiment of the present invention provides a thrombus aspiration system, comprising: suction sheath, sheath positioning stent and pusher as described above; the suction sheath comprises a sheath body, and the sheath positioning support is arranged at the distal end of the sheath body; the sheath positioning bracket is a self-expanding bracket structure with two open ends.
In addition, the diameter of the sheath positioning bracket gradually decreases from the distal end to the proximal end, and the sheath positioning bracket is woven by memory metal wires.
In addition, the proximal end of the sheath body is hermetically connected to the distal end of the sheath sealing device through a sheath connector; the sheath connector includes: a sheath joint and a stress diffusion tube; the sheath pipe joint is sleeved at the proximal end of the sheath pipe body and is fixedly connected with the distal end of the sheath pipe sealing device in a sealing way; the stress diffusion tube is sleeved at the proximal end of the sheath tube body and the sheath tube joint.
In addition, the suction sheath tube further comprises a sheath tube sealing device arranged at the proximal end of the sheath tube body; the sheath sealing device includes: a distal handle compression member, an elastic handle, a flexible membrane tube, an infusion assembly, and a proximal ram; the elastic handle includes: a distal seat, a proximal seat, and an elastic member; the far-end seat, the near-end seat and the elastic piece are fixedly connected with the integrated elastic tubular valve casing; the flexible membrane tube is of a tubular structure with a smooth inner wall and penetrates through the elastic tubular valve casing, the distal end of the flexible membrane tube is in sealing connection with the distal end seat, and the proximal end of the flexible membrane tube is in sealing connection with the proximal end seat, so that a sealing space is formed between the elastic tubular valve casing and the flexible membrane tube; the inner wall of the flexible membrane tube encloses a sealing channel of the sealing device; the infusion assembly is connected with the elastic tubular valve casing and used for adjusting the sealing pressure in the sealing space; the flexible membrane tube can be contracted and expanded circumferentially under the action of the sealing pressure, so that the flexible membrane tube can be contracted circumferentially to close the sealing channel or expanded circumferentially to form a sealing channel with the shape and the size of the self-adaptive introduction instrument; the elastic piece can radially and elastically deform along with the contraction and the relaxation of the flexible membrane tube; the distal handle compression member includes: a multi-way joint connected with the proximal end of the sheath tube body, wherein the proximal end of the multi-way joint is provided with a distal end insertion part extending along the axial direction; the distal end insertion part is inserted into the distal end of the flexible membrane tube, and a distal end sealing ring is clamped between the outer periphery of the distal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the distal end of the flexible membrane tube is in sealing connection with the distal end of the elastic cylindrical valve casing; the proximal pressure head is of a tubular structure, and a proximal insertion part extending along the axial direction is arranged at the distal end of the proximal pressure head; the proximal end insertion part is inserted into the proximal end of the flexible membrane tube, and a proximal end sealing ring is clamped between the outer periphery of the proximal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the proximal end of the flexible membrane tube is in sealing connection with the proximal end of the elastic handle.
In addition, the distal handle compression member further comprises: a distal annular boss disposed between the distal insertion portion and the sheath body; the proximal ram further comprises a proximal annular boss disposed at a proximal end of the proximal insertion portion; the inner wall of the far end seat of the elastic handle is provided with a far end annular groove matched with the far end annular boss; the multi-way joint and the distal seat are fixedly connected through the distal annular boss and the distal annular groove; the proximal end inner wall of the proximal end seat of the elastic handle is provided with a proximal end annular groove matched with the proximal end annular boss, and the proximal end pressure head and the proximal end seat are fixedly connected through the proximal end annular boss and the proximal end annular groove.
In addition, the thrombus aspiration system further includes a side-aspiration assembly coupled to the multi-port connector.
According to the technical scheme, the invention has at least the following advantages and positive effects:
in the thrombus aspiration system provided by the embodiment of the invention, the sheath locating support at the distal end of the aspiration sheath is received and released by the pusher, and the sheath locating support is expanded and supported on the vessel wall after being released, so that the aspiration port of the aspiration sheath can be centered, the injury to the vessel wall caused by aspiration of the aspiration sheath to one side is avoided, the aspiration port can be enlarged, the thrombus aspiration efficiency is improved, and the blood loss in the aspiration process is reduced.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being understood that the drawings in the following description are only embodiments of the present invention and that other drawings may be obtained according to the drawings provided without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram of a thrombus aspiration system according to an embodiment of the present invention;
FIG. 2 is a schematic view showing a partial sectional structure of a sheath positioning stent in a released state in a thrombus aspiration system according to an embodiment of the present invention;
fig. 3 is a schematic structural diagram of a pusher according to a first embodiment of the present invention;
FIG. 4 is a schematic view of the partial cross-sectional structure of FIG. 3;
fig. 5 is a schematic structural diagram of a thrombus aspiration system according to a second embodiment of the present invention;
FIG. 6 is a schematic view of the partial cross-sectional structure of FIG. 5;
fig. 7 is an exploded view of a thrombus aspiration system according to a second embodiment of the present invention;
fig. 8 is a schematic structural view of an elastic handle of a thrombus aspiration system according to a second embodiment of the present invention;
FIG. 9 is a schematic view of a distal handle compression member of a thrombus aspiration system according to a second embodiment of the present invention;
fig. 10 is a schematic structural view of a flexible membrane tube of a thrombus aspiration system according to a second embodiment of the present invention;
FIGS. 11a and 11b are schematic views showing the structure of a distal seat of an elastic handle in a thrombus aspiration system according to an embodiment of the present invention;
fig. 12a and 12b are schematic structural views of a proximal seat of an elastic handle in a thrombus aspiration system according to an embodiment of the present invention.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the following detailed description of the embodiments of the present invention will be given with reference to the accompanying drawings. However, those of ordinary skill in the art will understand that in various embodiments of the present invention, numerous technical details have been set forth in order to provide a better understanding of the present invention. However, the claimed invention may be practiced without these specific details and with various changes and modifications based on the following embodiments.
Unless otherwise indicated, references herein to proximal and distal have the same meaning in the orientation, i.e., in the use state, the distal end is the end distal from the operator, the proximal end is the end proximal to the operator, and the operator controls the sheath sealing device at the proximal end.
Referring to fig. 1-4, an embodiment of the present invention provides a pusher 2 that may be used with a thrombus aspiration system. The thrombus aspiration system includes: the suction sheath 1, the distal end of the suction sheath 1 is provided with a sheath positioning bracket 11. The pusher 2 may be threaded through the suction sheath 1 and used for delivery and release of the sheath positioning stent 11.
The pusher 2 of the embodiment of the present invention includes: a pusher head 21, a pusher bar 22 and a drive assembly.
The pusher head 21 has an annular cavity open to the proximal end for receiving the sheath positioning stent 11 in a compressed state, facilitating its receipt within the pusher head 21 from the distal end of the sheath positioning stent 11. Further, the distal end of the pusher head 21 is tapered, i.e. the pusher head 21 has a tapered tip, which improves the guiding and advancing ability of the suction sheath 1 in the blood vessel.
The distal end of the pushing rod 22 is connected to the proximal end of the pushing head 21, and the pushing head 21 and the pushing rod 22 can be arranged in the suction sheath 1 in a penetrating manner and can move axially relative to the suction sheath 1. The pusher head 21 may be secured to the distal end of the pusher bar 22 by welding, gluing or thermal fusion.
The distal end of the drive assembly may be coupled to the proximal end of the suction sheath 1, the drive assembly being fixedly coupled to the push rod 22 and configured to drive the push rod 22 distally within the suction sheath 1 to release the sheath positioning stent 11.
Referring to fig. 1-2, in use, the pusher 2 is inserted into the suction sheath 1, the sheath positioning bracket 11 at the distal end of the suction sheath 1 is received in the annular cavity of the pusher head 21, and the distal end of the drive assembly is connected to the proximal end of the suction sheath 1. Then the suction sheath tube 1 is pushed to the thrombus suction position, the pushing rod 22 is driven by the driving component to drive the pushing head 21 to move axially and distally in the suction sheath tube 1 so as to release the sheath tube positioning support 11, and the distal opening of the sheath tube positioning support 11 is opposite to the thrombus. The pusher 2 is then retracted entirely until the suction sheath 1 is completely withdrawn.
The driving assembly may include: pushing the handle and push button 25. The pushing handle is of a tubular structure, and the pushing rod 22 penetrates through the pushing handle and can axially move relative to the pushing handle. The push handle is provided with a slide lock mechanism, the push button 25 is fixedly connected with the push rod 22 and matched with the slide lock mechanism, the push button 25 is used for driving the push rod 22 to axially move relative to the push handle, and the slide lock mechanism can lock the push button 25 on the push handle. When the pushing head 21 reaches the target thrombus position, the pushing rod 22 can drive the pushing head 21 to move distally only by pushing the pushing button 25 so as to release the sheath positioning bracket 11, and when the pushing button 25 is released, the sliding lock mechanism can automatically lock the pushing button 25 on the pushing handle so as to prevent the pusher 2 from moving in the suction sheath 1.
The pushing handle may include: the handle body 24 and the handle joint 23 that sets firmly in the distal end of handle body 24, handle joint 23 is used for connecting pusher 2 to the proximal end of suction sheath 1. A handle adapter 23 may be screwed to the proximal end of the suction sheath 1.
The slide lock mechanism includes: the elastic locking piece is symmetrically arranged on the peripheral wall of the handle body 24 and comprises two groups of racks which are symmetrically arranged, and the elastic locking piece is fixedly arranged in the handle body 24 and extends along the axial direction. Each set of racks includes a plurality of axially uniformly distributed serrations 26. The push button 25 includes two symmetrically arranged operating parts, the outer end 251 of each operating part exposes the sliding groove respectively, and the inner end of each operating part includes: the fixing portion 253 connected to the push rod 22 is pressed against the lock head 252 of the rack. The push button 25 is movable along the chute within the handle body. The rack may be made of an elastic material, and pushing the outer end of the push button 25 overcomes the resistance of the rack to the locking head 252 at the inner end of the push button, so that the push rod 22 can axially move relative to the push handle. The push button 25 can be locked to the push handle by the locking action of the rack. The serrations 26 may be shaped to facilitate distal movement of the push button and to prevent proximal movement of the push button.
According to the pusher disclosed by the embodiment of the invention, when the push button is not pushed, the push rod can be locked on the push handle, and when the push button is pushed, the push head can be automatically unlocked and can be enabled to move to the far end to release the sheath positioning bracket, so that the operation is convenient.
Referring to fig. 1-2 and fig. 5-6, a thrombus aspiration system is provided in a second embodiment of the present invention, which can be used for aspiration of thrombus in a blood vessel. The thrombus aspiration system according to an embodiment of the present invention includes: suction sheath 1, sheath positioning support 11, and pusher 2 as described in example one. The suction sheath 1 includes: the sheath body 12 and the sheath sealing device 3, and the distal end of the sheath sealing device 3 is in sealing connection with the proximal end of the sheath body 12.
The sheath positioning bracket 11 is of a self-expanding bracket structure with two open ends, the sheath positioning bracket 11 is of a cylindrical structure, and can be attached to and supported on the inner wall of a blood vessel after being released and expanded, so that the pipe orifice at the far end of the sheath body 12 is positioned in the center of the blood vessel, and the damage to the wall of the blood vessel caused by the suction of the sheath body 12 towards one side of the blood vessel can be avoided; meanwhile, the sheath positioning bracket 11 also provides a larger suction port for the suction sheath 1, so that the overall suction efficiency can be improved, and the blood loss in the operation process can be reduced. Further, the diameter of the sheath positioning stent 11 gradually decreases from the distal end to the proximal end, which not only facilitates centering of the distal opening of the sheath body, but also provides a larger thrombus aspiration port. The sheath positioning bracket 11 can be woven by memory metal wires. The memory metal wire is made of nickel-titanium alloy wire with good shape memory capability.
The sheath sealing device 3 is arranged at the proximal end of the sheath body 12 and is in sealing connection with the proximal end of the sheath body 12. The sheath sealing device 3 has an on-off lumen (i.e., a sealing channel), the lumen of the sheath sealing device 3 communicates with the lumen of the sheath body 12, and the aspiration sheath 1 is available for thrombus aspiration when the sheath sealing device is open. When the pusher 2 and other instruments are arranged in the suction sheath tube 1 in a penetrating way, the sheath tube sealing device 3 can reliably seal the suction sheath tube, and meanwhile, the sheath tube sealing device 3 can also close a suction channel of the suction sheath tube 1.
Referring to fig. 1, 5 and 7, the sheath sealing device 3 includes: a distal handle compression member 31, a flexible handle 32, a flexible membrane tube 34, an infusion set, and a proximal ram 33.
Referring to fig. 8, the elastic handle 32 includes: a distal seat 321, a proximal seat 324, and a resilient member 325. The distal seat 321, the proximal seat 324, and the resilient member 325 are fixedly coupled together as an integral resilient tubular valve housing. The distal seat 321, the proximal seat 324 and the elastic member 325 are integrated by adopting an encapsulation process, so that the manufacturing process is simple and the structure is firm.
The flexible membrane tube 34 is a tubular structure with a smooth inner wall, the flexible membrane tube 34 is arranged in the elastic tubular valve casing in a penetrating way, the distal end of the flexible membrane tube 34 is in sealing connection with the distal end seat 321, and the proximal end of the flexible membrane tube 34 is in sealing connection with the proximal end seat 324, so that a sealing space is formed between the elastic tubular valve casing and the flexible membrane tube 34. The inner wall of the flexible membrane tube 4 encloses a sealing channel of the sealing device.
The infusion assembly is connected with the elastic tubular valve casing and is used for adjusting the sealing pressure in the sealing space. The pressure in the sealed space can be adjusted by varying the amount of fluid (gas or liquid) in the sealed space by the infusion set, thereby varying the sealing pressure acting on the flexible membrane tube 34.
Under the action of the sealing pressure, the flexible membrane tube 4 can shrink and expand circumferentially, so that the flexible membrane tube 4 can shrink to close the sealing channel, or expand circumferentially to form the sealing channel with the shape and the size of the self-adaptive introduction instrument, and the elastic piece 325 can elastically deform radially along with the shrinkage and the expansion of the flexible membrane tube 4. Namely, the flexible membrane tube 4 is made of a soft material and can circumferentially shrink and expand, the flexible membrane tube 4 realizes different sizes of sealing channels through circumferential shrinkage and expansion instead of self elastic deformation, and when no instrument is required to be introduced into the sealing channels, the flexible membrane tube 4 can realize circumferential shrinkage under the action of sealing pressure through folding and the like due to the self flexible structure and can shut off the sealing channels; when it is desired to introduce a shaped and sized instrument through the sealing channel, the flexible membrane tube 4 is able to circumferentially relax (expand) and form a sealing channel of the adapter mechanical shape and size under pressure, achieving a good seal. The elastic member 325 can radially shrink with the shrinkage of the flexible membrane tube 4 and radially expand with the expansion, that is, the elastic member 325 can shrink with the reduction of the sealing channel and expand with the increase of the sealing channel, so that the elastic deformation of the elastic member 325 can adaptively adjust the sealing pressure when forming the sealing channels with different sizes, so as to maintain good and stable sealing performance. The elastic member 325 can radially contract or expand to form the desired channel size of the instrument, so the radial deformation range of the elastic member 325 can determine the size range of the sealing channel. Meanwhile, the radial deformation of the elastic member 325 can also make the sealing pressure applied to instruments with different sizes close, so that a good sealing effect is always maintained. For example, when the outer diameter of the instrument passing through the sheath sealing device 3 is 5mm and 2mm, respectively, a plurality of times, the elastic member 325 may be radially contracted so that the diameter of the sealing passage is changed from the original 5mm to 2mm. Meanwhile, the pressure in the sealing space is relatively close, so that the sealing forces applied to the instruments with different sizes are relatively consistent, and a relatively good sealing effect can be maintained.
The distal end of the distal handle hold-down 31 is connected to the proximal end of the sheath body 12 and the proximal end thereof is connected to the distal end of the distal seat 321 of the flexible handle 32 to effect a sealed connection of the sheath body 12 to the sheath seal 3. At the same time, the distal handle grip 31 also serves to sealingly connect the flexible membrane tube 34 to the elastomeric tubular valve housing. The proximal ram 33 is disposed at the proximal end of the flexible handle 32, and the distal end of the proximal ram 33 serves as the outer end of the suction sheath 1 and may be connected to a pusher, suction pump, or the like. The proximal ram 33 is fixedly connected to the proximal hub 324 of the flexible handle 32, to the proximal end of the flexible membrane tube 34, and also cooperates with the proximal hub 324 to provide a sealed connection between the proximal end of the flexible membrane tube 34 and the proximal hub 324.
Referring to fig. 6 to 9, the distal handle pressing member 31 includes: the multi-way joint and the proximal end of the multi-way joint are provided with a distal insertion part 312 extending along the axial direction and a distal annular boss 311 arranged between the multi-way joint and the distal insertion part 312. The multi-way joint is in a tubular structure. The distal end insertion portion 312 is inserted into the distal end of the flexible membrane tube 34, and a distal end seal ring 3251 is interposed between the outer periphery of the distal end of the flexible membrane tube 34 and the inner wall of the elastic cylindrical valve housing, so that the distal end of the flexible membrane tube 34 is sealingly connected to the distal end of the elastic handle 32. The distal inner wall of the distal seat 321 of the resilient handle 32 is provided with a distal annular groove 3212 which mates with the distal annular boss 311. The distal handle pressing member 31 and the distal seat 321 are fixedly connected by a distal annular boss 311 and a distal annular groove 212. Therefore, the distal end insertion part 312 is inserted into the distal end of the flexible membrane tube 34 and is mutually matched with the distal end sealing ring 3251 in an extrusion manner, so that the distal end of the flexible membrane tube 34 is in sealing connection with the distal end of the elastic tubular valve casing, and meanwhile, the distal end handle pressing part 31 is matched with the distal end annular groove 3212 of the distal end seat 321 through the distal end annular boss 311, so that the connection and the fixation of the distal end handle pressing part 31 and the elastic handle 32 can be realized, and meanwhile, the glue fixation can be assisted, and the assembly steps are simple and easy to operate.
Further, a guide 314 is provided at the proximal end of the distal insertion portion 312. The guide 314 proximal to the distal insertion portion 312 is a necked down configuration with a diameter that decreases from distal to proximal to facilitate insertion of the distal insertion portion 312 into the flexible membrane tube 34.
The proximal ram 33 has a tubular structure, and is provided at its distal end with an axially extending proximal insertion portion 332 and a proximal annular boss 331 provided at the proximal end of the proximal insertion portion 332. The proximal end insertion portion 332 is inserted into the proximal end of the flexible membrane tube 34, and a proximal end seal ring 3252 is interposed between the proximal end outer periphery of the flexible membrane tube 34 and the inner wall of the elastic cylindrical valve housing, so that the proximal end of the flexible membrane tube 34 is in sealing connection with the proximal end of the elastic cylindrical valve housing. The proximal inner wall of the proximal seat 324 of the flexible handle 32 is provided with a proximal annular groove 3242 cooperating with the proximal annular boss 331, and the proximal ram 33 and the proximal seat 324 are fixedly connected by the proximal annular boss 331 and the proximal annular groove 3242. Therefore, the proximal end insertion part 332 is inserted into the proximal end of the flexible membrane tube 34 and is mutually matched with the proximal end sealing ring 3252 in an extrusion manner, so that the sealing between the proximal end of the flexible membrane tube 34 and the proximal end of the elastic tubular valve casing is realized, and meanwhile, the connection and fixation of the proximal end pressing head 33 and the elastic handle 32 can be realized through the matching of the proximal end annular boss 331 of the proximal end pressing head 33 and the proximal end annular groove 3242 of the proximal end seat 324, and meanwhile, the glue fixation can be assisted, and the assembly steps are simple and easy to operate.
Further, a guide 333 is provided at the distal end of the proximal insertion portion 332. The guide 333 distal to the proximal insertion portion 332 is also a necked down configuration to facilitate insertion of the proximal insertion portion 332 into the flexible membrane tube 34.
It should be noted that the flexible membrane tube 34 may be connected to the elastic cylindrical valve body in a sealing manner in other ways. The connection structure between the sheath body 12 and the sheath sealing device 3 is not limited to the boss and slot fitting method described in the present embodiment.
The sheath connector 13 sealingly connects the sheath body proximal end to the sheath seal distal end. The sheath connector 13 may include: sheath joint 132, stress diffusion tube 131. The sheath tube joint 132 is sleeved on the proximal end of the sheath tube body 12 and is fixedly connected with the distal end of the sheath tube sealing device 3 in a sealing way. Specifically, the proximal end of the sheath tube joint 132 is inserted into the distal end of the multi-way joint of the distal handle pressing member 31, and the proximal outer periphery of the sheath tube joint 132 is sealingly connected to the distal inner periphery of the multi-way joint of the distal handle pressing member 31 by a seal ring 133.
The stress diffusion tube 131 is sleeved on the proximal end of the sheath body 12 and the sheath joint 132. The diameter of the part of the stress diffusion tube 131 sleeved on the sheath tube body 12 gradually increases from the distal end to the proximal end along the axial direction of the part, and the part of the stress diffusion tube 131 sleeved on the sheath tube joint 132 is columnar, so that the suction sheath tube can be prevented from being bent in use.
The distal seat 321 is provided with a distal encapsulation structure, the elastic member 325 is integrally encapsulated with the distal seat 321 by the distal encapsulation structure, and the proximal seat 324 is provided with a proximal encapsulation structure. The elastic member 325 is integrally encapsulated with the proximal hub 324 by a proximal encapsulation structure such that the elastic member is securely coupled to the distal hub 321 and the proximal hub 324.
Referring to fig. 11a and 11b, the distal encapsulation structure is a spoke-like encapsulation structure. The spoke-like encapsulation structure includes: the annular outer seat 3211, an annular inner seat 3214 coaxially arranged in the annular outer seat 3211, and a plurality of connecting rubber coating ribs 3215 circumferentially arranged between the annular outer seat 3211 and the annular inner seat 3214 at intervals. The annular outer seat 3211, the annular inner seat 3214 and the plurality of connecting rubber coating ribs 3215 form a rubber filling gap, and the distal end part of the elastic member 325 is filled with rubber in a melting manner and solidified in the rubber filling gap, so that the distal end of the elastic member 325 and the distal end seat 321 are firmly combined into a whole.
It should be noted that, the annular outer housing 3211 of the distal housing 321 is provided with a through hole 3216, and the annular inner housing is provided with an opening 3217, which respectively serve as a channel structure to connect with the pouring hole 3253 of the elastic member 325 to form a pouring channel.
Referring to fig. 8, a distal end seat 321 is provided with an infusion port 3213 for connecting an infusion assembly, the infusion assembly comprises an infusion tube 322 and a two-way sealing valve 323, two ends of the infusion tube 322 are respectively connected with the infusion structure 213 and the two-way sealing valve 323, and the other end of the two-way sealing valve 323 can be connected with a syringe and the like. The distal end of the elastic member 325 is provided with a pouring aperture 3253 which communicates with the infusion port 3213. Distal seal ring 3251 is provided with a seal ring channel that communicates with irrigation hole 3253. The distal insertion portion 312 is provided with a recess 314 corresponding to the seal ring channel, and the recess 314 communicates with the seal space. The infusion interface 3213, the infusion hole 3253, the channel on the distal seat 321 and the sealing ring channel are sequentially communicated to form an infusion channel, and the sealing ring channel is opposite to the avoidance pit 314, so that the sealing space is communicated through the avoidance pit 314.
Referring to fig. 12a and 12b, the proximal encapsulation structure also employs a spoke-like encapsulation structure. The spoke-like encapsulation structure includes: the annular outer seat 3241, the annular inner seat 3243 coaxially arranged in the annular outer seat 3241, and a plurality of connecting rubber coated ribs 3244 circumferentially arranged between the annular outer seat 3241 and the annular inner seat 3243 at intervals. The annular outer base 3241, the annular inner base 3243 and the plurality of connecting rubber ribs 3244 form a rubber filling gap therebetween. The proximal portion of the elastic member 325 is melted and filled and solidified in the filling gap, so that the proximal end of the elastic member 325 and the proximal seat 324 are firmly combined together.
It should be noted that, the present embodiment does not specifically limit the proximal and distal encapsulation structures, as long as the elastic member can be firmly encapsulated and combined with the distal seat and the proximal seat.
The distal seat 321 and the proximal seat 324 may be formed from non-elastomeric materials, preferably PP, PC, ABS, etc. The elastic member 325 may be made of an elastomer material, preferably silica gel, rubber, TPU, etc., which are firmly combined together by an encapsulation process. The elastic member 325 may have a contracted cylindrical structure with two large ends and a small middle, which is convenient for radial deformation to form a desired sealing channel size and is convenient for holding as an operation handle.
The flexible membrane tube 34 is a flexible tube that is impermeable to water or gas and has a low elongation both circumferentially and axially. As shown in fig. 10, the flexible film tube 34 may include an outer layer 342 and an inner layer 341 with a smooth sealing surface. The inner layer 341 and the outer layer 342 form a flexible composite membrane tube structure. The sealing surface refers to the surface of the inner layer 341 facing the instrument passing through the sheath sealing arrangement. The inner layer 341 has a low coefficient of friction on its outer surface and may be made of expanded polytetrafluoroethylene (expanded Polytetrafluoro ethylene, abbreviated as EPTFE) and the outer layer 342 may be made of a flexible polymer material, preferably fluorinated ethylene propylene copolymer (Fluorinated ethylene propylene, abbreviated as FEP) or an elastomeric material, such as thermoplastic polyurethane elastomer rubber (Thermoplastic polyurethanes, abbreviated as TPU). And the length thereof should be not less than the distance between the guide portion 16 on the distal end insertion portion 312 and the end face of the guide portion 333 of the proximal end insertion portion 332, the axial length of the flexible membrane tube 34 should be such that it can seal off the suction channel after its radial relaxation.
It should be noted that, the sheath sealing device 3 may also adopt other sealing structures that can be opened and closed, and the present invention is not limited in particular.
Referring to fig. 6, the thrombus aspiration system may further include a side-aspiration assembly coupled to the multi-port connector. The side draw assembly includes: suction tube 141 and two-way suction valve 142. After the axial suction channel of the suction sheath is closed by the sheath sealing device 3, thrombus suction can be performed through the side suction assembly, so that the convenience of clinical use is greatly improved.
Referring to fig. 1, 2 and 5, the working principle of the thrombus aspiration system according to the embodiment of the present invention is as follows: pushing the suction sheath 1 to reach a designated suction position, pushing the push button 25 of the pusher 2, driving the pushing head 21 to move distally to release the sheath positioning bracket 11, expanding and attaching the sheath positioning bracket 11 to the vessel wall after release, rotating the handle joint 23 to separate the pusher 2 from the suction sheath 1, and completely withdrawing the pusher 2 from the suction sheath 1. At this time, the opening of the sheath positioning bracket 11 may be facing the thrombus. During aspiration, the side-pumping assembly can be closed, the two-way sealing valve 323 connected with the infusion assembly through the injector is closed after negative pressure is pumped to the sheath sealing device 3, the inner cavity of the sheath sealing device 3 is opened, and the outer end of the proximal pressure head 33 of the sheath sealing device is connected with a negative pressure suction pump, so that thrombus can be aspirated. Or the sheath sealing device is filled with gas or liquid to close the inner cavity of the sheath sealing device, and then the two-way suction valve 142 of the side suction assembly is opened for suction.
Based on the technical scheme, the embodiment of the invention has at least the following advantages and positive effects:
in the thrombus aspiration system provided by the embodiment of the invention, the sheath locating support at the distal end of the aspiration sheath is received and released by the pusher, and the sheath locating support is expanded and supported on the vessel wall after being released, so that the aspiration port of the aspiration sheath can be centered, the injury to the vessel wall caused by aspiration of the aspiration sheath to one side is avoided, the aspiration port can be enlarged, the thrombus aspiration efficiency is improved, and the blood loss in the aspiration process is reduced.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of carrying out the invention and that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
Claims (9)
1. A thrombus aspiration system, comprising: a suction sheath, a sheath positioning bracket and a pusher;
the suction sheath comprises a sheath body, and the sheath positioning support is arranged at the distal end of the sheath body;
the sheath positioning bracket is a self-expanding bracket structure with two open ends;
the pusher can be arranged on the suction sheath tube in a penetrating way, and a sheath tube positioning bracket is arranged at the distal end of the suction sheath tube; the pusher is used for conveying and releasing the sheath positioning bracket; the pusher comprises:
a pusher head having an annular cavity open to a proximal end for receiving the sheath positioning stent in a compressed state;
the distal end of the pushing rod is connected with the proximal end of the pushing head, and the pushing rod and the pushing head can be arranged on the suction sheath tube in a penetrating way and can axially move relative to the suction sheath tube; and
the driving assembly is fixedly connected with the pushing rod and used for driving the pushing rod to move distally in the suction sheath so as to release the sheath positioning bracket;
the suction sheath tube further comprises a sheath tube sealing device arranged at the proximal end of the sheath tube body;
the sheath sealing device includes: a distal handle compression member, an elastic handle, a flexible membrane tube, an infusion assembly, and a proximal ram;
the elastic handle includes: a distal seat, a proximal seat, and an elastic member; the far-end seat, the near-end seat and the elastic piece are fixedly connected to form an integrated elastic tubular valve casing;
the flexible membrane tube is of a tubular structure with a smooth inner wall and low elongation in the circumferential direction and the axial direction, the flexible membrane tube penetrates through the elastic tubular valve housing, the distal end of the flexible membrane tube is in sealing connection with the distal end seat, and the proximal end of the flexible membrane tube is in sealing connection with the proximal end seat, so that a sealing space is formed between the elastic tubular valve housing and the flexible membrane tube; the inner wall of the flexible membrane tube encloses a sealing channel of the sealing device;
the infusion assembly is connected with the elastic tubular valve casing and used for adjusting the sealing pressure in the sealing space; the flexible membrane tube can be circumferentially folded and unfolded under the action of the sealing pressure, so that the flexible membrane tube can be circumferentially folded and folded to close the sealing channel or circumferentially unfolded to form a sealing channel with the shape and the size of the self-adaptive introduction instrument; and the elastic member is radially contractible with contraction of the flexible film tube and radially expandable with expansion of the flexible film tube.
2. The thrombus aspiration system of claim 1 wherein the distal handle compression member comprises: a multi-way joint connected with the proximal end of the sheath tube body, wherein the proximal end of the multi-way joint is provided with a distal end insertion part extending along the axial direction; the distal end insertion part is inserted into the distal end of the flexible membrane tube, and a distal end sealing ring is clamped between the outer periphery of the distal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the distal end of the flexible membrane tube is in sealing connection with the distal end of the elastic cylindrical valve casing;
the proximal pressure head is of a tubular structure, and a proximal insertion part extending along the axial direction is arranged at the distal end of the proximal pressure head; the proximal end insertion part is inserted into the proximal end of the flexible membrane tube, and a proximal end sealing ring is clamped between the outer periphery of the proximal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the proximal end of the flexible membrane tube is in sealing connection with the proximal end of the elastic handle.
3. The thrombus aspiration system of claim 1, wherein the drive assembly comprises:
the pushing handle is of a tubular structure, the pushing rod penetrates through the pushing handle, and the pushing handle is provided with a sliding lock mechanism; a kind of electronic device with high-pressure air-conditioning system
The push button is fixedly connected with the push rod and matched with the sliding lock mechanism, the push button is used for driving the push rod to axially move relative to the push handle, and the sliding lock mechanism can lock the push button on the push handle.
4. A thrombus aspiration system as in claim 3 wherein the push handle comprises: the handle connector is used for connecting the pusher to the proximal end of the sheath tube sealing device;
the slide lock mechanism includes: the elastic locking piece is provided with two groups of racks which are symmetrically arranged; each group of racks respectively comprises a plurality of saw teeth which are uniformly distributed along the axial direction;
the push button includes two operation parts of symmetry setting, the outer end of operation part exposes respectively the spout, the inner of operation part includes: and the fixed part is connected with the pushing rod and is propped against the locking head of the rack.
5. The thrombus aspiration system of claim 1 wherein the pusher head distal end is tapered.
6. The thrombus aspiration system of claim 1 wherein the sheath positioning stent tapers in diameter from distal end to proximal end and is braided from a memory wire.
7. The thrombus aspiration system of claim 1 wherein the sheath body proximal end is sealingly connected to the distal end of the sheath sealing device by a sheath connector;
the sheath connector includes: a sheath joint and a stress diffusion tube; the sheath pipe joint is sleeved at the proximal end of the sheath pipe body and is fixedly connected with the distal end of the sheath pipe sealing device in a sealing way;
the stress diffusion tube is sleeved at the proximal end of the sheath tube body and the sheath tube joint.
8. The thrombus aspiration system of claim 2 wherein the distal handle compression member further comprises: a distal annular boss disposed between the distal insertion portion and the sheath body; the proximal ram further comprises a proximal annular boss disposed at a proximal end of the proximal insertion portion;
the inner wall of the far end seat of the elastic handle is provided with a far end annular groove matched with the far end annular boss; the multi-way joint and the distal seat are fixedly connected through the distal annular boss and the distal annular groove;
the proximal end inner wall of the proximal end seat of the elastic handle is provided with a proximal end annular groove matched with the proximal end annular boss, and the proximal end pressure head and the proximal end seat are fixedly connected through the proximal end annular boss and the proximal end annular groove.
9. The thrombus aspiration system of claim 2, further comprising a side-aspiration assembly connected to the multi-port connector.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111360924.9A CN113974776B (en) | 2021-11-17 | 2021-11-17 | Pusher and thrombus aspiration system comprising same |
| PCT/CN2021/138199 WO2023087456A1 (en) | 2021-11-17 | 2021-12-15 | Pusher and thrombus aspiration system having same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111360924.9A CN113974776B (en) | 2021-11-17 | 2021-11-17 | Pusher and thrombus aspiration system comprising same |
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| Publication Number | Publication Date |
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| CN113974776A CN113974776A (en) | 2022-01-28 |
| CN113974776B true CN113974776B (en) | 2023-06-02 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202111360924.9A Active CN113974776B (en) | 2021-11-17 | 2021-11-17 | Pusher and thrombus aspiration system comprising same |
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| CN (1) | CN113974776B (en) |
| WO (1) | WO2023087456A1 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113974775B (en) * | 2021-11-17 | 2023-05-16 | 上海腾复医疗科技有限公司 | Sheath sealing device and thrombus aspiration system comprising same |
| CN115068054B (en) * | 2022-05-24 | 2023-04-07 | 上海玮琅医疗科技有限公司 | Expander subassembly suitable for from expansion device |
| CN115153756B (en) * | 2022-07-05 | 2023-09-12 | 上海玮琅医疗科技有限公司 | Expander assembly suitable for self-expanding device |
| CN118121267A (en) * | 2022-11-28 | 2024-06-04 | 先健科技(深圳)有限公司 | Thrombolysis sheath tube assembly |
| CN117018401A (en) * | 2023-06-30 | 2023-11-10 | 苏州汇禾医疗科技有限公司 | Catheter sheath for interventional therapy |
| CN117442408B (en) * | 2023-12-25 | 2024-03-12 | 北京华脉泰科医疗器械股份有限公司 | Gear shifting type push-pull conveyor |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN113974776A (en) | 2022-01-28 |
| WO2023087456A1 (en) | 2023-05-25 |
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