CN111481265A

CN111481265A - Quick-exchange type blood vessel thrombus removal device

Info

Publication number: CN111481265A
Application number: CN202010456238.0A
Authority: CN
Inventors: 刘洪泽
Original assignee: Shenyang Mastech Medical Device Co ltd
Current assignee: Shenyang Mastech Medical Device Co ltd
Priority date: 2020-05-26
Filing date: 2020-05-26
Publication date: 2020-08-04

Abstract

The invention relates to the technical field of medical instruments, in particular to a quick-exchange type blood vessel thrombus taking device which comprises a guide end, a thrombus taking component, a core wire, a sheath tube and a handle, wherein the guide end comprises a guide end body and a wire guide cavity arranged in the guide end body, the near end of the guide end is connected with the far end of the core wire, the thrombus taking component is of a net structure and is sleeved on the core wire, the near end of the thrombus taking component is fixed on the core wire, the far end of the thrombus taking component is open, the sheath tube is sleeved outside the core wire and the thrombus taking component, the near end of the sheath tube is connected with the far end of the handle, the far end of the sheath tube is open, the handle is sleeved outside the core wire, and the near end of the handle is of a locking structure and is used for locking or unlocking. The invention not only can effectively capture thrombus, but also can realize the quick exchange with other instruments on the premise of keeping the guide wire when in use, and is more convenient and quick to use.

Description

Quick-exchange type blood vessel thrombus removal device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a rapid exchange type blood vessel thrombus removal device.

Background

Intravascular thrombosis is a common disease in clinical practice, and can be divided into arterial thrombosis and venous thrombosis according to the affected vascular system. Wherein arterial thrombosis can cause ischemia and even necrosis of the corresponding organ dominated by the affected blood vessel, thereby threatening the life of the patient. In addition, the arterial thrombus has the characteristics of high morbidity, high disability rate, high mortality rate and high recurrence rate, and is a great killer of human health.

Intravascular thrombus treatment generally involves two types, namely, drug thrombolysis and mechanical thrombectomy. The mechanical thrombus removal is used as a novel thrombus treatment method, and is particularly suitable for patients with unsatisfactory thrombolytic effect or unsuitable thrombolytic treatment.

The mechanical thrombus taking device is characterized in that under the assistance of medical imaging technology, a blood vessel thrombus taking device is conveyed to a blood vessel embolism part or a blood vessel embolism far end through a catheter and released, thrombus is adhered to the blood vessel thrombus taking device through mechanical embedding, catching and the like, and then the thrombus is taken out of a body through recovering the blood vessel thrombus taking device.

The Chinese patent application 201211048890.1 discloses an intracranial vascular thrombus removal device, which comprises a thrombus removal device, a guide wire, a push-pull guide wire and an outer sheath tube, wherein the thrombus removal device is connected with the push-pull guide wire, and the installed push-pull guide wire and the thrombus removal device are pressed and held in the outer sheath tube, wherein the thrombus removal device forms a tube cavity and can be switched between a retraction position and a deployment position by pushing and pulling the push-pull guide wire. The thrombus taking device of the thrombus taking device is provided with a certain number of barbs on the inner wall of a tube cavity, and the barbs are inclined relative to the tube wall. The thrombus can be firmly fixed in the recovery process of the thrombus taking device after the thrombus is captured, the capturing stability is improved, and the thrombus is prevented from falling off.

Chinese patent application 201310100143.5 discloses an intracranial vascular embolectomy device and embolectomy device, wherein the embolectomy device is of a net structure and can be switched between a retracted position and a deployed position, and the embolectomy device is configured with a concave and/or convex structure. This thrombectomy ware is at the recovery in-process after catching the thrombus, can firmly fix the thrombus, improves and catches stability, prevents that the thrombus from droing, has avoided vascular wall plaque and garrulous thrombus piece to drop easily and cause the problem of distal end blood vessel embolism once more, and small, compliance are good moreover.

The Chinese patent application 201610009736.4 discloses a blood vessel thrombus taking device with a spiral structure and a thrombus therapeutic apparatus thereof, which comprises a developing ring, a developing ring and a thrombus taking device arranged between the developing ring and the developing ring, wherein the thrombus taking device comprises a tube net or cage structure consisting of a plurality of unit grids which are mutually connected; the net-like or cage-like structure is open, and has longitudinal gaps on its side surface, and the longitudinal gaps spirally extend along the outer surface of the net-like or cage-like structure. The thrombus therapeutic apparatus comprises a blood vessel thrombus taking device with a spiral structure, a protective sheath tube, a delivery wire, a micro-catheter, a guide catheter and a rotary hemostatic valve, wherein the micro-catheter is pushed to the position of a thrombus in the guide catheter along the guide catheter, the protective sheath tube is communicated with the micro-catheter through the rotary hemostatic valve, and the thrombus taking device is placed in the protective sheath tube and pushed into the micro-catheter by a delivery wire. The thrombus therapeutic apparatus has good flexibility, and the thrombus taking device can be used for bending a blood vessel or reaching a thin blood vessel at a far end to minimize the injury to the blood vessel wall.

Chinese patent application 201811237116.1 discloses an intracranial thrombus extraction device, which has a hollow tubular structure, a radially compressed loading state and a radially expanded release state, wherein one axial end of the tubular structure is a proximal end for connecting a delivery instrument, the other end is a distal end sealed by a mesh enclosure structure, and a plurality of trapping claws are further provided, one end of each trapping claw is a root connected with the side wall of the tubular structure, the other end is a tip extending to the axial position of the tubular structure, and each trapping claw is inclined from the proximal end to the distal end while extending. According to the intracranial thrombus extraction device, the trapping claws with proper extension direction and proper body length are arranged in the thrombus extraction support, so that the thrombus extraction effect is further improved.

The technical scheme provided by the vascular thrombus taking device mainly solves the problem of how to effectively capture thrombus, but in the use mode, the vascular thrombus taking device still needs to be matched with a guide wire, a guide catheter and a microcatheter for use. In addition, in the thrombus removal process, due to the existence of conditions such as long thrombus disease and multiple thrombus disease, the thrombus removal is often required to be performed for a plurality of times, and in this case, the blood vessel thrombus removal device needs to be repeatedly exchanged with the guide wire when used, thereby increasing the operation steps and the operation time. In clinical practice, the earlier the thrombus is taken out, the blocked blood vessel is opened, and the complication of the thrombus and the treatment cost can be reduced.

For the above reasons, there is a need for a novel blood vessel embolectomy device, which does not require removal of a guide wire during use, and can realize rapid exchange between the blood vessel embolectomy device and other instruments, so that the operation steps can be simplified, and the operation time can be shortened.

Disclosure of Invention

In order to solve the technical problem, the invention provides a rapid exchange type blood vessel embolectomy device.

The invention is realized in such a way, and provides a rapid exchange type blood vessel embolectomy device, which comprises a guide end, an embolectomy component, a core wire, a sheath tube and a handle, wherein the guide end comprises a guide end body and a wire guide cavity arranged in the guide end body, the near end of the guide end is connected with the far end of the core wire, the embolectomy component is of a net structure and is sleeved on the core wire, the near end of the embolectomy component is fixed on the core wire, the far end of the embolectomy component is open, the sheath tube is sleeved outside the core wire and the embolectomy component, the near end of the sheath tube is connected with the far end of the handle, the far end of the sheath tube is open, the handle is sleeved outside the core wire, and the near end of the handle is of a locking structure and is used for locking or.

Preferably, the distal end of the guide end is a guide head with a diameter gradually reduced, the proximal end is provided with a fixing groove for the core wire, one end opening of the guide wire cavity is positioned at the distal end of the guide head, and the other end opening is positioned on the side surface of the guide end body.

Further preferably, both ends of the embolectomy member are provided with developing markers opaque to X-rays.

Preferably, the core wire comprises a thin section, a transition section and a thick section, the far end of the thin section is connected with the guide end, the thrombus taking component and the sheath tube are sleeved outside the thin section, and the thick section is positioned in the handle.

Further preferably, the sheath comprises a sheath inner layer, a sheath intermediate layer and a sheath outer layer from inside to outside, the sheath inner layer and the sheath outer layer are polymer layers, and the sheath intermediate layer is a metal braid layer.

Further preferably, a distal end of the sheath tube is provided with an X-ray opaque visualization marker.

Further preferably, the handle includes the casing, and the destressing pipe is connected to the distal end of casing, and the near-end of casing is connected interior pad, and the near-end of interior pad is four independent, has the movable rod of certain distance between adjacent, and a circular passageway is constituteed to four movable rods inside, and the knob is cup jointed to the near-end outside screw thread of casing, and the near-end of knob is equipped with the opening that the internal diameter outwards dwindles gradually from the inside, and the near-end of interior pad contacts with the near-end inboard of knob, and along with rotatory, four movable rods of pad in the knob extrusion, knob, interior pad, casing and destressing pipe are passed in proper order to.

Preferably, the plug removing device is a net structure processed by super-elastic titanium-nickel alloy, and the core wire is processed by super-elastic titanium-nickel alloy wire.

Compared with the prior art, the invention has the advantages that:

the rapid exchange type blood vessel thrombus taking device provided by the invention not only can effectively capture thrombus, but also can realize rapid exchange with other instruments on the premise of reserving a guide wire when in use, and is more convenient and rapid to use.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a schematic structural view of a vascular embolectomy device provided by the invention in a compressed state.

Fig. 2 is a schematic structural view of the vascular embolectomy device provided by the invention in a deployed state.

Fig. 3 is a schematic structural diagram of the leading end.

Fig. 4 is a schematic structural view of the bolt-removing component.

Fig. 5 is a schematic view of the structure of the core wire.

Fig. 6 is a schematic structural view of the sheath.

Fig. 7 is a sectional view of the sheath.

Fig. 8 is a schematic view of the structure of the locking handle.

Fig. 9 is a side view of the inner pad.

Fig. 10 is a front view of the inner pad.

Fig. 11a is a schematic diagram of a first step of a conventional vascular embolectomy device in use.

Fig. 11b is a schematic diagram of a second step of the use of the conventional vascular embolectomy device.

Fig. 11c is a third schematic diagram of the use process of the conventional vascular embolectomy device.

FIG. 11d is a fourth step of the conventional thrombectomy device.

Fig. 12a is a schematic view of a first step of the use process of the vascular embolectomy device provided by the invention.

Fig. 12b is a second step schematic view of the use of the vascular embolectomy device provided by the present invention.

Fig. 12c is a third schematic view of the use process of the vascular embolectomy device provided by the invention.

In the figure, 1 is a leading end, 2 is a thrombus taking component, 3 is a core wire, 4 is a sheath, 5 is a handle, 11 is a leading end body, 12 is a guide wire cavity, 21 is a thrombus taking component body, 22 and 23 are development markers, 31 is a thin section, 32 is a transition section, 33 is a thick section, 41 is a sheath inner layer, 42 is a sheath middle layer, 43 is a sheath outer layer, 44 is a sheath development marker, 51 is a handle shell, 52 is a stress removing tube, 53 is a knob, 54 is an inner pad, 6 is a blood vessel, 7 is a thrombus, 8 is a guide wire, 9 is a microcatheter, and 10 is a guide catheter.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Referring to fig. 11a, fig. 11b, fig. 11c and fig. 11d, there are shown the working steps of the prior art blood vessel embolectomy device: the conventional blood vessel thrombectomy device needs to be matched with the guide wire 8, the micro-catheter 9 and the guide catheter 10 for thrombectomy, and the process is as follows: (1) a guide catheter 10 is sent to the vicinity of the position where the thrombus 7 occurs, and a guide wire 8 and a microcatheter 9 are sent to the position where the thrombus 7 occurs; (2) withdrawing the guide wire 8, guiding the blood vessel thrombus removal device into the micro-catheter 9, and delivering the blood vessel thrombus removal device to the position where the thrombus 7 occurs through the micro-catheter 9; (3) withdrawing the microcatheter 9, releasing the thrombus taking component of the blood vessel thrombus taking device to the position where the thrombus 7 occurs, wherein if the length of the thrombus 7 is less than the length of the thrombus taking component, the thrombus 7 is completely covered by the thrombus taking component, and if the length of the thrombus 7 is more than the length of the thrombus taking component, the proximal end of the thrombus 7 is partially covered by the thrombus taking component; (4) the vascular embolectomy device and the microcatheter 9 are withdrawn and removed together from the body through the guide catheter 10.

When the conventional blood vessel thrombus taking device is used for treating long thrombus lesion and multiple thrombus lesion, the thrombus cannot be completely taken out at one time. If multiple embolisms are required, a guide wire and microcatheter need to be placed in place prior to each embolisms. Since the vascular condition at the site of thrombus formation can be complex, such as bifurcation, calcification, stenosis, etc., each placement of a guide wire and microcatheter can be challenging for the clinician, and a situation in which successful placement is likely to occur. The repeated operation not only increases the operation steps and the operation time and complicates the operation process, but also may bring higher operation risk to the patient, cause complications and influence the prognosis effect.

In order to solve the technical problems, referring to fig. 1 and 2, the present invention provides a rapid-exchange type vascular thrombus removal device, which includes a guiding end 1, a thrombus removal component 2, a core wire 3, a sheath tube 4 and a handle 5, wherein the guiding end 1 includes a guiding end body 11 and a guide wire cavity 12 arranged inside the guiding end body 11, a proximal end of the guiding end 1 is connected to a distal end of the core wire 3, the thrombus removal component 2 is of a mesh structure and is sleeved on the core wire 3, a proximal end of the thrombus removal component 2 is fixed on the core wire 3, a distal end is of an open type, the sheath tube 4 is sleeved outside the core wire 3 and the thrombus removal component 2, a proximal end of the sheath tube 4 is connected to a distal end of the handle 5, a distal end of the sheath tube 4 is of an open type, the handle 5 is sleeved outside the core wire 3, and a proximal end of the handle 5 is of a locking structure for locking or unlocking the core wire 3.

When the device is used for thrombus removal, as shown in fig. 12a, 12b and 12c, the thrombus removal operation needs to be used together with the guide wire 8 and the guide catheter 10, and the process is as follows: (1) delivering a guide catheter 10 to the vicinity of the site where the thrombus 7 occurs, and delivering a guide wire 8 and a vascular thrombus removal device to the site where the thrombus 7 occurs; (2) releasing a thrombus taking component of the blood vessel thrombus taking device to a thrombus 7 occurrence part, wherein if the length of the thrombus 7 is less than the length of the thrombus taking component, the thrombus 7 is completely covered by the thrombus taking component, and if the length of the thrombus 7 is more than the length of the thrombus taking component, the proximal end of the thrombus 7 is partially covered by the thrombus taking component; (3) the vascular embolectomy device and the microcatheter 9 are withdrawn and removed together from the body through the guide catheter 10.

The rapid exchange type blood vessel embolectomy device provided by the invention can lead the guide wire 8 to freely pass through the guide end 1 through the guide wire cavity 12, and can still perform embolectomy operation under the condition of not withdrawing the guide wire 8. Because the guide wire 8 is reserved, when thrombus needs to be taken out for many times, no matter other instruments or the vascular thrombus taking device provided by the invention are used for taking the thrombus again, the thrombus can reach the thrombus generation part as long as the other instruments or the vascular thrombus taking device pass through the guide wire, the operation steps are greatly simplified, and the operation risk is effectively reduced.

For the convenience of connecting a guide wire, referring to fig. 3, as an improvement, the distal end of the guide end 1 is a guide head with a gradually reduced diameter, the proximal end is provided with a fixing groove for the core wire 3, one end of the guide wire cavity 12 is open at the distal end of the guide head, and the other end is open at the side of the guide end body 11.

In use, the distal end of the leading end 1 is inserted into the proximal end of the guide wire 8, and the guide wire 8 is free to move within the guide wire lumen 12.

An X-ray visualization device is generally required for interventional procedures, and referring to FIG. 4, in order to facilitate identification of the embolectomy member 2 during the embolectomy procedure, as an improvement, both ends of the embolectomy member 2 are provided with X-ray opaque visualization markers. The proximal end is a first development marker 23, the distal end is a second development marker 22, and the second development marker 22 is provided in plurality because the distal end is an open end. Materials of the development marker include, but are not limited to, gold, platinum, tungsten, platinum iridium alloy, platinum tungsten alloy, and the like. Whether the embolectomy member is sufficiently released can be known by observing whether the distal marker of the embolectomy member 2 is open.

In order to reduce the size of the embolectomy site and facilitate the relative movement between the embolectomy part 2 and the sheath 4, as an improvement, referring to fig. 5, the core wire 3 comprises a thin section 31, a transition section 32 and a thick section 33, the distal end of the thin section 31 is connected with the leading end 1, the embolectomy part 2 and the sheath 4 are sleeved outside the thin section 31, and the thick section 32 is positioned inside the handle 5.

If the external diameter of the part of the core wire 3 sleeved with the embolectomy component 2 is thicker, the superposed outline size of the core wire and the embolectomy component 2 is larger, which is not beneficial to the relative movement between the embolectomy component 2 and the sheath tube 4. Because the plug taking component 2 will be released from the sheath tube 4 when taking the plug, if the external diameter of the core wire 3 and the plug taking component 2 after being overlapped is too large, the gap between the plug taking component 2 and the sheath tube 4 is small, the friction force between the two will be correspondingly large, which is not beneficial to the release of the plug taking component 2, if the outline size is too large, it may cause the plug taking component 2 not to be inserted into the sheath tube 4.

Preferably, referring to fig. 6 and 7, the sheath tube 4 includes a sheath inner layer 41, a sheath intermediate layer 42 and a sheath outer layer 43 from inside to outside, the sheath inner layer 41 and the sheath outer layer 43 are polymer layers, and the sheath intermediate layer 42 is a metal braid layer. The material of the sheath intermediate layer 42 includes, but is not limited to, stainless steel, nitinol, etc.

In order to facilitate the identification of the sheath tube 4, as an improvement, the distal end of the sheath tube 4 is provided with an X-ray opaque visualization marker.

When the sheath 4 is retracted, the visualization marker of the sheath 4 is retracted behind the proximal marker of the embolectomy member 2, indicating that the embolectomy member 2 is fully released.

In order to ensure that the core wire 3 and the sheath tube 4 can be locked or relatively moved according to the needs of an operator, as an improvement, referring to fig. 8, 9 and 10, the handle 5 includes a housing 51, a distal end of the housing 51 is connected with a stress removing tube 52, a proximal end of the housing 51 is connected with an inner pad 54, a proximal end of the inner pad 54 is provided with four independent movable rods having a certain distance therebetween, a circular channel is formed inside the four movable rods, a knob 53 is threadedly sleeved outside a proximal end of the housing 51, a proximal end of the knob 53 is provided with an opening having an inner diameter gradually reduced from inside to outside, a proximal end of the inner pad 54 is in contact with a proximal inner side of the knob 53, and the knob 53 presses the four movable rods of the inner pad 54, and the core wire 3 sequentially passes through the knob 53, the inner pad 54, the housing 51 and the stress removing tube.

By rotating the knob 53 on the locking mechanism, the knob will squeeze or release the four movable rods of the inner pad 54 of the locking mechanism. When the knob 53 presses the inner pad 54, the locking mechanism is in a locked state, in which the core wire 3 cannot move relative to the sheath 4 and the handle 5, and when the knob 53 releases the inner pad 54, the locking mechanism is in an unlocked state, in which the core wire 3 can freely pass through the sheath 4 and the handle 5.

Preferably, the plug removing device 2 is a pipe net structure processed by super-elastic titanium-nickel alloy, and the core wire 3 is processed by super-elastic titanium-nickel alloy wire.

As used herein, "distal" refers to the end of the instrument distal to the operator, and "proximal" refers to the end of the instrument proximal to the operator.

The embodiments of the present invention have been described in detail with reference to the drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge of those skilled in the art without departing from the gist of the present invention.

Claims

1. A rapid exchange type blood vessel thrombus taking device is characterized by comprising a guide end (1), a thrombus taking component (2), a core wire (3), a sheath tube (4) and a handle (5), wherein the guide end (1) comprises a guide end body (11) and a wire guide cavity (12) arranged inside the guide end body (11), the near end of the guide end (1) is connected with the far end of the core wire (3), the thrombus taking component (2) is of a net-shaped structure and is sleeved on the core wire (3), the proximal end of the plug taking component (2) is fixed on the core wire (3), the distal end is open, the sheath tube (4) is sleeved outside the core wire (3) and the plug taking component (2), the proximal end of the sheath tube (4) is connected with the distal end of the handle (5), the distal end of the sheath tube (4) is open, the handle (5) is sleeved outside the core wire (3), and the proximal end of the handle (5) is of a locking structure and used for locking or loosening the core wire (3).

2. The rapid exchange type thrombectomy device according to claim 1, wherein the distal end of the guiding end (1) is a gradually decreasing diameter guiding head, the proximal end is provided with a fixing groove for the core wire (3), one end of the guidewire lumen (12) is open at the distal end of the guiding head, and the other end is open at the side of the guiding end body (11).

3. The rapid exchange vascular embolectomy device of claim 1, wherein both ends of the embolectomy member (2) are provided with radiopaque visualization markers.

4. The rapid exchange type vascular embolectomy device of claim 1, wherein the core wire (3) comprises a thin section (31), a transition section (32) and a thick section (33), the distal end of the thin section (31) is connected with the leading end (1), the embolectomy member (2) and the sheath (4) are sleeved outside the thin section (31), and the thick section (33) is positioned inside the handle (5).

5. The rapid-exchange-type thrombectomy device according to claim 1, wherein the sheath (4) comprises an inner sheath layer (41), a middle sheath layer (42) and an outer sheath layer (43) from inside to outside, wherein the inner sheath layer (41) and the outer sheath layer (43) are polymer layers, and the middle sheath layer (42) is a metal braid layer.

6. The rapid exchange vascular embolectomy device of claim 1, wherein the distal end of the sheath (4) is provided with an X-ray opaque visualization marker.

7. The rapid exchange type thrombus removal device according to claim 1, wherein the handle (5) comprises a housing (51), the far end of the housing (51) is connected with the stress removal tube (52), the near end of the housing (51) is connected with an inner pad (54), the near end of the inner pad (54) is provided with four independent movable rods which are spaced from each other, a circular channel is formed inside the four movable rods, the outer side of the near end of the housing (51) is in threaded connection with the knob (53), the near end of the knob (53) is provided with an opening of which the inner diameter is gradually reduced from inside to outside, the near end of the inner pad (54) is in contact with the inner side of the near end of the knob (53), the knob (53) extrudes the four movable rods of the inner pad (54) along with rotation, and the core wire (3) sequentially passes through the knob (53), the inner pad (54), the housing (51) and the stress removal tube (52.

8. The rapid exchange vascular embolectomy device of claim 1, wherein the embolectomy device (2) is a mesh structure machined from a super-elastic titanium-nickel alloy, and the core wire (3) is machined from a super-elastic titanium-nickel alloy wire.