CN216855483U

CN216855483U - Novel artery thrombus taking catheter

Info

Publication number: CN216855483U
Application number: CN202121113293.6U
Authority: CN
Inventors: 裴强; 葛泉波; 冯志辉
Original assignee: Shanghai Weiyu Medical Technology Co ltd
Current assignee: Leo Medical Co ltd
Priority date: 2021-05-22
Filing date: 2021-05-22
Publication date: 2022-07-01
Anticipated expiration: 2031-05-22

Abstract

The utility model provides a novel artery thrombus removal catheter, which comprises: blocking sheath, dilator and thrombectomy device. The blocking sheath comprises a sheath tube, the distal end of the sheath tube is provided with a balloon, the proximal end of the sheath tube is connected with a handle, at least two cavities are arranged in the sheath tube, and the first cavity communicates the inner cavity of the balloon with a balloon filling joint on the handle; the proximal end of the second cavity is communicated with a negative pressure suction device connected with the handle, and the handle is also provided with an opening part axially communicated with the second cavity; the dilator can extend into the second cavity of the sheath tube from the opening part of the handle; the thrombus taking device capable of extending into the second cavity from the opening part of the handle comprises a soft head, a nickel-titanium core, a coating and a dense-mesh thrombus taking piece, wherein the near end of the dense-mesh thrombus taking piece is connected with the nickel-titanium core, the far end of the dense-mesh thrombus taking piece is in an open state, and the dense-mesh thrombus taking piece can be expanded or folded by drawing the nickel-titanium core. The thrombus taking catheter can effectively improve the arterial thrombus clearance rate and reduce the blood loss.

Description

Novel artery thrombus taking catheter

Technical Field

The utility model relates to the technical field of artery thrombus removal, in particular to a thrombus removal catheter suitable for medium-diameter arteries (5-10 mm).

Background

The existing treatment methods mainly comprise vascular incision embolectomy, catheter contact thrombolysis and mechanical percutaneous puncture embolectomy, the incision embolectomy requires dissection separation and dissection of blood vessels such as femoral artery, femoral vein or brachial artery, the open operation mode is gradually replaced by minimally invasive interventional intracavity treatment along with the development of intracavity interventional techniques and the innovation of materials, namely catheter contact thrombolysis and mechanical percutaneous puncture embolectomy, the catheter contact thrombolysis has high risk of thrombolysis due to the bleeding of thrombolysis drugs, the operation adaptation is extremely strict, and most patients have contraindications of catheter contact thrombolysis, so many patients cannot benefit from the open operation mode.

The stent type embolectomy is a mechanical embolectomy method which is newly appeared, namely, under the assistance of medical imaging technology, a stent type embolectomy device is sent to a vascular embolism position through a catheter and released, the stent type embolectomy device is unfolded automatically and is embedded with thrombus by means of self expansion force, and then the embolectomy device is withdrawn to take out the thrombus.

The Chinese patent CN103417257B discloses an intracranial vascular thrombus removal catheter, the distribution density of spiral mesh ring units of the thrombus removal catheter is different, the distribution of the spiral mesh ring units is dense at the far end, the distribution of the spiral mesh ring units is relatively sparse at the near end, and therefore, the thrombus can be effectively prevented from falling off. Chinese patent application CN103997976A discloses an embolectomy cage having an elongated axis and a circumference, comprising elongated members that collectively define a plurality of open cells, which is effective in removing emboli. Chinese patent CN105726088A discloses a thrombus extraction device, which comprises a reticular self-expanding stent and a core wire, wherein the stent is in a cylindrical expansion state, the proximal end of the stent is provided with an opening, and the distal end of the stent is closed.

As mentioned above, the current stent-type thrombus extractor or thrombus extraction catheter is limited by the structure, the sparse stent rod is used for capturing thrombus or sucking the thrombus under negative pressure, and the thrombus is pulled out of the body, but when the thrombus is extracted, the force of the stent-type thrombus extractor or thrombus extraction catheter acting on the thrombus is not uniform, the thrombus is easy to fall off from the thrombus extractor, or thrombus fragments are generated to block a far-end blood vessel or enter other blood vessels, and the blood loss amount is too large due to the long-time negative pressure. In addition, current stent-type embolisers or embolisers do not work well for old thrombi and for extensive embolization. Based on the existing medical cognition, the deep venous thrombosis is often large in capacity, and the acute-phase thrombosis is soft and fragile in texture; arterial thrombosis often has small volume, acute-stage thrombosis is soft in texture, and old thrombosis often adheres to the vessel wall. At present, a stent type thrombus removal catheter with a sparse structure is usually developed for nerve thrombus removal, and the effect is not ideal for thrombus in medium-diameter arterial blood vessels. Therefore, there is a need for an easy-to-embolise embolectomy catheter.

Disclosure of Invention

In view of the above disadvantages of the prior art, the present invention provides a novel thrombectomy catheter, which is used for solving the problems of thrombus shedding and overflowing and excessive blood loss when the stent thrombectomy device in the prior art is used.

To achieve the above and other related objects, the present invention provides an embolectomy catheter, comprising:

the blocking sheath comprises a sheath tube, a balloon is arranged at the far end of the sheath tube, a handle is connected with the near end of the sheath tube, at least two axially extending cavities are arranged in the sheath tube, the inner cavity of the balloon is communicated with a balloon filling joint connected to the handle through a first cavity, and a developing mark is arranged on the sheath tube on the balloon side; the proximal end of the second cavity is communicated with a negative pressure suction device which is connected with the handle, and the handle is also provided with an opening part which is axially communicated with the second cavity;

the outer diameter of the dilator is matched with the inner diameter of the second cavity of the sheath tube, the dilator can extend into the second cavity of the sheath tube from the opening part of the handle, and the distal end of the dilator penetrates out of the second cavity of the sheath tube and seals the second cavity of the sheath tube;

the thrombus taking device comprises a tip, a nickel-titanium core, a coating and an expandable dense-mesh thrombus taking piece, wherein the near end of the dense-mesh thrombus taking piece is connected with the nickel-titanium core, the far end of the dense-mesh thrombus taking piece is in an open state, and the dense-mesh thrombus taking piece can be expanded or folded by pulling the nickel-titanium core; the thrombus taking device can extend into the second cavity from the opening part of the handle, the near end of the dense-mesh thrombus taking piece penetrates out of the second cavity, and the near end of the nickel-titanium core is exposed out of the outer side of the opening part of the handle.

Preferably, the handle is provided with a connecting buckle, the proximal end of the dilator is connected with a handheld part, and the handheld part is provided with a connecting part matched and fixed with the connecting buckle.

Preferably, the sheath tube is composed of two braided tubes, namely an inner tube and an outer tube, the proximal end of the braided tube is of a Braid structure, the distal end of the braided tube is of a Coil structure, and the main body of the sheath tube is made of polyurethane or polyamide thermoplastic elastomer.

Preferably, the inner cavity of the inner tube of the sheath tube forms a second cavity, and the inner cavity of the outer tube and the inner tube form a first cavity; the effective length of the sheath is 90 cm-150 cm, preferably 150 cm.

Preferably, the inner diameter of the inner pipe is 1.67 mm-2.33 mm, preferably 2.00 mm; the outer diameter of the outer pipe is 2.66 mm-3.00 mm, preferably 2.66 mm.

Preferably, the balloon is made of natural latex, synthetic rubber, silica gel or polyurethane.

Preferably, the maximum filling outer diameter of the balloon is 10 mm.

Preferably, the dilator is made of polyethylene or polyurethane, and barium sulfate, bismuth oxide or bismuth oxychloride is filled in the polyethylene or polyurethane.

Preferably, the dense mesh-shaped plug taking piece is formed by weaving a superelastic memory nickel-titanium alloy wire mixed with a platinum-iridium alloy wire, a gold wire or a stainless steel wire.

Preferably, the maximum expansion outer diameter of the dense mesh-shaped embolectomy piece is 10mm, and the weaving mesh number of the dense mesh is 40-80 PPI.

Preferably, the far end of the nickel-titanium core is sleeved with a soft head, the soft head is made of polyurethane containing a developer, and the length of the soft head is 5 cm-10 cm.

Preferably, the near end of the nickel-titanium core is sleeved with a coating, the coating is made of polytetrafluoroethylene, and the outer diameter of the nickel-titanium core covered with the coating is 0.018 inch-0.035 inch.

Preferably, the nickel-titanium core can be additionally provided with a detachable guide wire locking device.

As mentioned above, the thrombus removal catheter of the utility model has the following beneficial effects: the saccule at the far end of the sheath tube is inflated to block the blood flow at the near end, so that thrombus is enclosed between the dense mesh-shaped thrombus taking piece and the saccule, thrombus taking is easy, the dense mesh-shaped thrombus taking piece can enable blood to pass through meshes on the dense mesh-shaped thrombus taking piece, thrombus can be effectively prevented from overflowing to blood vessels at other parts in the thrombus taking process when thrombus taking operation is carried out, and the dense mesh-shaped thrombus taking piece and the blocking saccule cooperate with negative pressure suction to reduce the blood loss to the minimum limit when thrombus taking is carried out; the thrombus extractor is provided with a tip with a thinner tip and a nickel-titanium core, and can reach a position with deeper thrombus along the guide catheter; the thrombus extraction device is suitable for thrombus extraction of medium-sized arterial blood vessels, comprises relatively old lesions, and is particularly suitable for absorbing thrombus on limbs; the thrombus removal catheter is a passive thrombus removal instrument, is low in cost and simple to operate, and can greatly reduce the cost of thrombus removal operation.

Drawings

Fig. 1 shows a schematic view of the dilator of the present invention inserted within an occlusion sheath.

Fig. 2 is a cross-sectional view taken along line AA in fig. 1.

Fig. 3 shows a schematic view of the blocking sheath of the present invention.

Fig. 4 shows a schematic view of the dilator of the present invention.

FIG. 5 is a schematic view of the embolectomy device of the present invention.

Fig. 6 is a cross-sectional view taken along line BB in fig. 5.

Fig. 7 is a schematic view of the embolectomy device of the present invention inserted into the blocking sheath and in a furled state.

FIG. 8 is a schematic view of the embolectomy device of the present invention inserted into an occlusion sheath and in an expanded state.

Description of the element reference numerals

1 dilator

2 developing mark

3 saccule

4 sheath pipe

5 negative pressure suction device

6 handle

7 balloon filling joint

8 hand-held part

9 joint

10 connecting pipe

41 outer tube

42 inner pipe

11 connecting fastener

12 connecting part

121 notch

13 Soft head

14 dense net-shaped bolt taking piece

15 tube body

151 coating

152 nickel titanium core

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure.

Please refer to fig. 1 to 8. It should be understood that the structures, ratios, sizes, and the like shown in the drawings are only used for matching the disclosure of the present disclosure, and are not used for limiting the conditions that the present disclosure can be implemented, so that the present disclosure is not limited to the technical essence, and any structural modifications, ratio changes, or size adjustments should still fall within the scope of the present disclosure without affecting the efficacy and the achievable purpose of the present disclosure. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are used for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms may be changed or adjusted without substantial change in the technical content.

For convenience of description, the embolic catheter is defined herein as being distal in use, with the end distal from the operator being the distal end and the end held by the operator being the proximal end, along its length.

As shown in fig. 1 to 8, the present invention provides an embolectomy catheter, which includes:

the blocking sheath is shown in fig. 3 and comprises a sheath tube 4, a balloon 3 is arranged at the far end of the sheath tube 4, a handle 6 is connected with the near end of the sheath tube 4, at least two axially extending cavities are arranged in the sheath tube 4, the far end of a first cavity is communicated with an inner cavity of the balloon 3, the near end of the first cavity is communicated with a balloon filling joint 7 connected with the handle 6, and developing marks 2 are arranged on the sheath tube 4 at two sides of the balloon 3; the proximal end of the second cavity is communicated with a negative pressure suction device 5 which is connected with a handle 6, and the handle 6 is also provided with an opening part which is axially communicated with the second cavity; the inner cavity of the inner tube 42 of the sheath tube forms a second cavity, and the inner cavity of the outer tube 41 and the inner tube 42 form a first cavity;

the dilator 1, the external diameter of the dilator 1 is matched with the internal diameter of the second cavity of the sheath tube 4, can extend into the second cavity of the sheath tube 4 from the opening part of the handle 6, and the distal end of the dilator 1 passes out of the second cavity of the sheath tube 4 and seals the second cavity of the sheath tube 4;

the embolectomy device, as shown in fig. 5, comprises a tip 13, a nitinol core 152, a coating 151, and an expandable dense-mesh embolectomy member 14, wherein both ends of the nitinol core 152 are exposed outside both sides of the blocking sheath 4, the nitinol core 152 can move axially relative to the blocking sheath or can be fixed relative to each other (a locker needs to be selected), the distal end of the dense-mesh embolectomy member 14 is in an open state, and the dense-mesh embolectomy member 14 can be expanded or collapsed by pulling the nitinol core; the thrombectomy device can extend into the second cavity from the opening of the handle 6, and the distal end of the nitinol core 152 passes out of the second cavity, as shown in fig. 7 and 8, and the proximal end of the nitinol core 152 is exposed outside the opening of the handle 6.

The thrombus taking catheter comprises three components, namely the blocking sheath, the dilator and the thrombus taking device, the proximal end of the thrombus is blocked by the balloon 3 filled at the distal end of the sheath tube 4, so that blood flow is blocked, the thrombus is enclosed between the dense mesh-shaped thrombus taking piece 14 and the balloon 3, thrombus taking is easy, the dense mesh-shaped thrombus taking piece 14 can enable blood to pass through meshes of the dense mesh-shaped thrombus taking piece 14, due to compactness of the dense mesh-shaped thrombus taking piece 14, a stopping film is easily formed on the surface of the dense mesh-shaped thrombus taking piece 14 during thrombus taking operation, the thrombus can be effectively prevented from overflowing to blood vessels of other parts beyond the dense mesh-shaped thrombus taking piece in the thrombus taking process, negative pressure suction is matched while the dense mesh-shaped thrombus taking piece and the blocking balloon thrombus taking, the blood loss is reduced to the minimum, and the thrombus taking catheter is particularly suitable for sucking medium-capacity thrombus.

In this embodiment, the opening of the handle 6 is provided with a connecting buckle 11, the dilator 1 is provided with a connecting part 12 which is matched and fixed with the connecting buckle 11, and the dilator 1 is fixed with the blocking sheath through the fixing of the connecting part 12 and the connecting buckle 11, so as to be convenient for penetrating into the blood vessel. In this embodiment, the connection buckle 11 is provided with a protruding portion, the connection portion 12 is provided with a notch 121, when the dilator 1 penetrates into the second cavity of the sheath tube 4 from the opening portion of the handle 6, the dilator 1 is connected to the blocking sheath by the protruding portion being clamped in the notch 121, and the dilator 1 is separated from the blocking sheath by the matching of the protruding portion and the notch 121, so that the dilator 1 is easily pulled out from the blocking sheath.

The positioning connection between the handle 6 and the dilator 1 is not limited to the engagement between the connection buckle 12 and the connection portion 11, but may be achieved by providing a rotatable positioning portion that locks the dilator after the positioning portion is tightened. The handle 6 may also lock the bolt remover by a rotatable detent.

To facilitate insertion of the dilator 1, a handle 8 is connected to the proximal end of the dilator 1, and the operator can insert the dilator 1 into the sheath 4 through the opening of the handle 6 by holding the handle 8 with his hand. For medical imaging, the dilator 1 in this embodiment is made of a thermoplastic elastomer such as polyethylene or polyurethane, and barium sulfate, bismuth oxide or bismuth oxychloride containing a developer is filled in the thermoplastic elastomer.

In the embodiment, the sheath tube 4 in the blocking sheath is of a double-tube structure and consists of an inner tube and an outer tube, wherein the inner cavity of the inner tube forms a second cavity, and the inner cavity of the outer tube and the inner tube form a first cavity; the first cavity is used as a channel for filling the saccule 3, the other cavity, namely the second cavity, is used as a working cavity for passing the dilator 1 or the embolectomy device or other medical instruments in and out of the blood vessel, and the sheath tube 4 is made of polyurethane or polyamide thermoplastic elastomer. In this embodiment, the balloon 3 is made of thermoplastic elastomer such as natural latex, synthetic rubber, silica gel or polyurethane, and contrast agent is injected through the balloon filling cavity joint 7 on the handle 6 to expand the balloon to block blood flow. In order to extract thrombus, the negative pressure suction device 5 is connected with the handle 6 through a connecting pipe 10, and the negative pressure suction device 5 is further connected with a joint 9, so that the negative pressure suction device can be conveniently connected with an electric negative pressure aspirator to form suction negative pressure, and the thrombus can more efficiently flow into a collecting device of the negative pressure suction device 5 from the blocking sheath.

In the above-mentioned thrombectomy device of this embodiment, the dense mesh thrombectomy member 14 is woven from superelastic memory nickel-titanium alloy wires, and a certain amount of platinum-iridium alloy wires, gold wires or stainless steel wires are mixed and woven for developing under an X-ray machine, which allows blood to flow through the dense mesh thrombectomy member during thrombectomy, and can effectively prevent thrombectomy from overflowing to blood vessels at other parts during thrombectomy; when the dense-mesh embolectomy piece is used for embolectomy, negative pressure suction is matched, so that the amount of blood loss can be effectively reduced, and the thrombus suction effect can be effectively improved. The diameter of the super elastic memory nickel-titanium alloy wire used by the dense mesh-shaped embolectomy piece in the embodiment is 0.05-0.08 mm, the weaving mesh number of the dense mesh is 40-80 PPI, and the pore diameter of the mesh is about 0.1-0.5mm, namely the dense mesh-shaped embolectomy piece in the embodiment is a dense mesh-shaped piece, so that blood can pass through and thrombus can be prevented from passing through. Meanwhile, the soft dense net can reduce the damage of the vascular intima.

To facilitate expansion and collapse of the dense mesh embolectomy device, in this embodiment the embolectomy device is passed through a guide catheter to the distal end of the thrombus, the guide catheter is withdrawn, and the dense mesh embolectomy device 14 is expanded, as shown in FIGS. 5 and 7. In this embodiment, the tube body formed by the coating 151 and the nitinol core 152 can be used as a handle, which is convenient for an operator to take the thrombus removal device, and to draw the thrombus into the blocking sheath. The tube body can be optionally provided with a locking joint which can be a rotary or switch type locking piece, and the inner tube and the outer tube can be locked by rotating or switching.

Referring to fig. 7 and 8, in the embodiment, the proximal end of the dense mesh-shaped embolectomy member 14 is connected to the nitinol core, the distal end is in an open state, the embolectomy device is carried by the guiding catheter to pass through the thrombus and be pushed to the distal end of the thrombus, the guiding catheter is withdrawn to expand the dense mesh-shaped embolectomy member 14, the nitinol core 152 is pulled in the direction of the arrow in fig. 8, and the thrombus is dragged to the second lumen of the occlusion sheath.

The specific process of extracting thrombus in the blood vessel by adopting the thrombus extraction catheter is as follows:

after a puncture cannula is inserted into a blood vessel and the position of a thrombus and the condition of surrounding blood vessels are known through angiography, firstly, the dilator 1 is arranged in a second cavity of the sheath tube 4 in a penetrating way, as shown in fig. 1 and fig. 2, the dilator 1 is arranged in a blocking sheath in a penetrating way, and then, the sheath tube 4 is guided to the proximal end of the thrombus under the guide of a guide wire; connecting a balloon cavity joint 7 with normal saline or other appropriate liquid medicine to fill the balloon 3 to the inner diameter of the blood vessel, so that the balloon blocks the blood vessel at the proximal end of the thrombus and blocks the blood flow; withdrawing the dilator 1 from the blocking sheath and placing the thrombectomy device along the guiding catheter, which carries the distal end of the thrombectomy device through the thrombus and to the distal end of the thrombus, as shown in fig. 7; withdrawing the guiding catheter, expanding the dense mesh embolectomy member 14, pulling the nitinol core 152 of the embolectomy device towards the proximal end, as shown in fig. 8, taking the thrombus into the sheath 4 of the blocking sheath, simultaneously sucking the thrombus into the negative pressure suction device 5 by negative pressure suction, and when pulling the thrombus, blood can pass through the dense mesh embolectomy member 14, reducing the amount of blood loss, but the massive thrombus can be sucked out along with the suction; after the thrombus is taken out from a certain section of blood vessel, the balloon on the blocking sheath is inflated and placed, and the blood vessel is moved to the next section of thrombus for continuing thrombus taking out operation.

In conclusion, the thrombus removal catheter provided by the utility model blocks the blood flow by blocking the filling of the balloon at the distal end of the sheath, and the soft dense mesh thrombus removal piece reduces the damage to the vascular intima in the thrombus removal process; the dense mesh-shaped embolectomy piece can enable blood to pass through the mesh openings of the dense mesh-shaped embolectomy piece, so that the embolus of the thrombus can be effectively prevented from overflowing to blood vessels of other parts in the embolectomy operation, the dense mesh-shaped embolectomy piece is matched with negative pressure suction while embolectomy is performed, the thrombus can be removed, and the blood loss is reduced to the minimum; is suitable for the thrombus removal of medium-diameter arterial blood vessels (5 mm-10 mm), including relatively old lesions; the utility model is a passive embolectomy instrument, has low cost and simple operation, and can greatly reduce the expense of embolectomy; can efficiently take out large-capacity thrombus, reduce vascular injury, use less thrombolytic drugs, lose less blood, cause less trauma and have quicker recovery period. Therefore, the utility model effectively overcomes various defects in the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the utility model. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. An arterial thrombectomy catheter, comprising:

2. The embolectomy catheter of claim 1, wherein: the handle is provided with a connecting buckle, the near end of the dilator is connected with a handheld part, and the handheld part is provided with a connecting part which is matched and fixed with the connecting buckle.

3. The embolectomy catheter of claim 1, wherein: the sheath tube is composed of an inner tube and an outer tube, the near end of the braided tube is of a Braid structure, and the far end of the braided tube is of a Coil structure; the sheath main body is made of polyurethane or polyamide thermoplastic elastomer.

4. The embolectomy catheter of claim 3, wherein: the inner cavity of the inner tube of the sheath tube forms a second cavity, and the inner cavity of the outer tube and the inner tube form a first cavity; the effective length of the sheath is 90 cm-150 cm, preferably 150 cm.

5. The thrombectomy catheter of claim 3, wherein: the inner diameter of the inner pipe is 1.67 mm-2.33 mm, and the outer diameter of the outer pipe is 2.66 mm-3.00 mm.

6. The embolectomy catheter of claim 1, wherein: the balloon is made of natural latex, synthetic rubber, silica gel or polyurethane.

7. The embolectomy catheter of claim 6, wherein: the maximum filling outer diameter of the balloon is 10 mm.

8. The embolectomy catheter of claim 1, wherein: the dilator is made of polyethylene or polyurethane, and barium sulfate, bismuth oxide or bismuth oxychloride is filled in the polyethylene or polyurethane.

9. The embolectomy catheter of claim 1, wherein: the dense-mesh bolt taking piece is formed by weaving a superelastic memory nickel-titanium alloy wire mixed with a platinum-iridium alloy wire and a gold wire or a stainless steel wire.

10. The embolectomy catheter of claim 9, wherein: the maximum expansion outer diameter of the dense mesh-shaped plug taking piece is 10mm, and the weaving mesh number of the dense mesh is 40-80 PPI.

11. The embolectomy catheter of claim 1, wherein: the far end of the nickel-titanium core is a tapered head end, the head end is sleeved with a soft head, the soft head is made of polyurethane containing a developer, and the length of the soft head is 5 cm-10 cm.

12. The embolectomy catheter of claim 1, wherein: the near end of the nickel-titanium core is sleeved with a coating, and the coating is made of polytetrafluoroethylene.

13. The embolectomy catheter of claim 12, wherein: the outer diameter of the nickel-titanium core coated with the coating is 0.018 inch-0.035 inch.

14. The embolectomy catheter of claim 12, wherein: the nickel-titanium core can be additionally provided with a detachable guide wire locking device.