CN209884980U

CN209884980U - Novel micro-catheter

Info

Publication number: CN209884980U
Application number: CN201920043011.6U
Authority: CN
Inventors: 张钲; 王平; 肖建平; 向东东; 于伟
Original assignee: Shenzhen Industrial Co Ltd Poly Industry
Current assignee: Shenzhen Industrial Co Ltd Poly Industry
Priority date: 2018-12-19
Filing date: 2019-01-11
Publication date: 2020-01-03
Anticipated expiration: 2029-01-11

Abstract

The utility model discloses a novel little pipe, for the tubular structure, include head end, pipe shaft, diffusion stress pipe and the needle file that sets gradually from distal end to near-end, wherein: developing materials are doped in the head end, and a developing ring is arranged between the head end and the tube body; the pipe body sequentially comprises an outer sleeve layer, a woven reinforcing layer, a woven layer and an inner liner layer from outside to inside; and the near end of the tube body is fixedly connected with the needle seat, and the joint of the near end of the tube body and the needle seat is sleeved with the diffusion stress tube. The utility model discloses a novel little pipe has very strong propelling movement performance, anti bending performance and tracking performance, and the pipe hardens from the distal end to the near-end gradually simultaneously, can guarantee the compliance and the shape holding performance of distal end like this, ensures little pipe and at the operation process accurate arrival patient pathological change position and pass tortuous pathological change blood vessel of operation process.

Description

Novel micro-catheter

Technical Field

The utility model relates to a little pipe especially relates to a novel little pipe.

Background

With the development of social economy, the national life style is deeply changed, particularly, the aging of population and the urbanization progress are accelerated, the prevalence trend of cardiovascular disease risk factors in China is obvious, and the number of people suffering from cardiovascular diseases is continuously increased. At present, about 220 tens of thousands of patients suffering from chronic total occlusion lesions of coronary arteries in China exist.

Clinically, when minimally invasive interventional therapy is performed on a blood vessel with chronic total occlusion lesion or a vascular dissection, in order to improve the success rate of crossing of a guide wire, a micro catheter and the guide wire are usually required to be used in a matched manner, firstly, the micro catheter provides extra supporting force for the guide wire in the tiny blood vessel, and the micro catheter and the guide wire alternately go forward, so that the capability of the guide wire in crossing the occlusion lesion is greatly improved.

After the guide wire passes through the lesion site, the guide wire is required to be confirmed to be positioned in the blood vessel true cavity so as to carry out the next treatment operation, such as balloon expansion, stent implantation and other technical means. Injecting contrast agent to the far end of the blood vessel to evaluate whether the guide wire is in the true lumen of the blood vessel through imaging.

In the operation process, the microcatheter needs to be pushed to the pathological change position from the outside of the body, so that the microcatheter is required to have strong pushing performance, bending resistance performance, tracking performance and the like, the microcatheter is ensured to accurately reach the pathological change part of a patient and pass through the pathological change blood vessel in the operation process without damaging the healthy blood vessel, and meanwhile, the guide wire is convenient to pass through and withdraw.

The existing microcatheter generally cannot meet the requirements of small catheter size, excellent pushing performance, bending resistance and tracking performance, so that the difficulty of guide wire crossing occluded lesions is increased, the operation requirements on a medical doctor are increased, the time of the catheter in a patient is prolonged, and the influence on the body of the patient is increased.

CN107376101A describes a microcatheter for transcatheter arterial chemoembolization TACE, comprising: the device comprises a pipe seat, a diffusion stress pipe, a pipe body and a head end; the diffusion stress pipe sleeve is sleeved outside the joint of the pipe seat and the pipe body and is fixed with the pipe seat in an inverted buckling mode; the pipe body comprises an inner liner, a reinforcing layer and an outer sleeve layer; the reinforcing layer comprises a braided section, an overlapping section and a spiral section, wherein the braided section is close to the tube seat, the spiral section is close to the head end, and the overlapping section is positioned between the braided section and the spiral section; the spiral section adopts single spiral silk to make coil spring's structure, and the microcatheter head end that this patent expressed has good compliance, and the head end has good shape retention ability simultaneously, but, the propelling movement nature performance is relatively poor, because the only one deck weaving layer of near-end is strengthened, if want to improve the wall thickness that the propelling movement performance must increase the pipe, can increase the size of pipe like this, increase pipe size can increase the degree of difficulty through tortuous blood vessel, increase the risk and the degree of difficulty of operation simultaneously.

US 7507229B2 describes a multi-layer catheter for extending deep into the human body comprising an inner liner, a woven layer and an outer sheath. The catheter provides the high degree of flexibility and strength required to traverse the vascular system. The outer sheath layer is composed of 7 gradually-hardened polymer materials, the weaving density of the middle weaving layer is changed only once, and the process that the hardness of the micro-catheter gradually hardens from the far end to the near end cannot be achieved.

In summary, the following problems are common to the existing microcatheter: microcatheters have difficulty in combining good size with good physical properties; microcatheters do not ensure gradual stiffening from the distal to the proximal end of the catheter shaft; the flexibility is good, but the pushing performance is not good, and the folding is easy; the shape retention ability of the tip is not good, and the tip cannot smoothly enter the bifurcation part of the blood vessel.

SUMMERY OF THE UTILITY MODEL

The utility model discloses a solve the above-mentioned technical problem that current little pipe exists, provide an existing good size, have good physical properties again, the head end has the novel little pipe of good shape retention ability again simultaneously.

In order to achieve the above purpose, the utility model adopts the following technical scheme:

the utility model provides a novel little pipe, for tubular structure, include head end, pipe shaft, diffusion stress pipe and the needle file that sets gradually from distal end to near-end, wherein:

developing materials are doped in the head end, and a developing ring is arranged between the head end and the tube body;

the pipe body sequentially comprises an outer sleeve layer, a woven reinforcing layer, a woven layer and an inner liner layer from outside to inside; and

the near-end of the tube body is fixedly connected with the needle seat, and the diffusion stress tube is sleeved at the joint of the near-end of the tube body and the needle seat.

Further, the outer diameter of the head end becomes gradually larger from the distal end to the proximal end.

Furthermore, the material of the head end is soft polyamide or soft polyurethane.

Further, the developing material is one or a combination of more of tungsten powder, barium sulfate, bismuth trioxide, bismuth subcarbonate and calcium tungstate.

Further, the near-end face of the head end is lap-welded on a woven layer, and the woven layer and the inner liner layer at the far end of the tube body extend out of the tube body.

Further, the developing ring is embedded in the head end, and completely covers the far end face of the woven layer.

Furthermore, the developing ring is made of platinum-iridium alloy, gold or platinum.

Further, the thickness of the inner liner layer is 0.008-0.02 mm.

Further, the material of the inner liner layer is high-density polyethylene or polytetrafluoroethylene.

Further, the inner diameter of the inner liner layer is gradually increased from the far end to the near end, the inner diameter of the far end of the inner liner layer is 0.41-0.45mm, and the inner diameter of the near end of the inner liner layer is 0.48-0.53 mm.

Furthermore, the weaving layer is formed by weaving stainless steel weaving wires or nickel titanium weaving wires, and the weaving wires are round wires, flat wires or oval wires.

Further, the number of braided wires of the braided layer is 16-32 strands, the braided layer has a braided density PPI which is gradually reduced from the distal end to the proximal end, the braided density PPI at the distal end of the braided layer is 220-280, and the braided density PPI at the proximal end of the braided layer is 50-100.

Further, the braided reinforcing layer is arranged at the proximal end of the tube body, and the length of the braided reinforcing layer is 800-1100 mm.

Furthermore, the braided reinforcing layer is formed by braiding stainless steel braided wires or nickel titanium braided wires in a double-wire mode, the number of braided wires of the braided reinforcing layer is 20-36 strands, and a plurality of braided reinforcing wires 10 are horizontally arranged in the braided reinforcing layer.

Further, the near end face of the diffusion stress tube is fixedly connected with the far end face of the needle seat through a buckle.

Further, the hardness of the outer sleeve layer is gradually increased from the distal end to the proximal end, and the hardness of the outer sleeve layer ranges from 30D to 71D.

Further, the outer sleeve layer is made of polyamide, polyurethane and polyolefin materials with different hardness;

further, the outer diameter of the outer sleeve layer is gradually increased from the distal end to the proximal end, the outer diameter of the distal end of the outer sleeve layer is 0.05-0.066mm, and the inner diameter of the proximal end of the outer sleeve layer 4 is 0.81-0.92 mm.

Further, the outer surface of the outer sleeve layer is coated with a hydrophilic coating.

The above technical scheme is adopted in the utility model, compared with the prior art, following technological effect has:

the utility model discloses a novel little pipe has very strong propelling movement performance, anti bending performance and tracking performance, and the pipe hardens from the distal end to the near-end gradually simultaneously, can guarantee the compliance and the shape holding performance of distal end, ensures little pipe and accurately reachs patient's pathological change position and passes circuitous pathological change blood vessel at the operation process.

Drawings

FIG. 1 is a schematic view of the overall structure of the novel microcatheter;

FIG. 2 is a schematic view of the braided structure of the novel microcatheter;

FIG. 3 is a schematic sectional view of the body and head of the novel microcatheter;

FIG. 4 is a schematic view of the braided layer braiding structure of the novel microcatheter;

FIG. 5 is a cross-sectional view of section A-A of the novel microcatheter;

FIG. 6 is a schematic view of the braided structure of the braided layer of the novel microcatheter;

FIG. 7 is a schematic view of the braided structure of the braided reinforcement layer in the novel microcatheter;

FIG. 8 is a cross-sectional view of section B-B of the novel microcatheter;

FIG. 9 is a schematic structural view of the outer jacket layer of the novel microcatheter;

FIG. 10 is a schematic view of the structure of the tip of the novel microcatheter

FIG. 11 is a schematic view of the new microcatheter in position for vascular access;

wherein the reference symbols are:

1-head end, 2-tube body, 3-needle seat, 4-outer sleeve layer, 5-inner liner layer, 6-braided layer, 7-braided reinforced layer, 8-diffusion stress tube, 9-developing ring, 10-braided reinforced wire, 11 tower boss protrusion and 12-tower boss groove.

Detailed Description

The present invention will be described in detail and specifically with reference to specific embodiments so as to provide a better understanding of the present invention, but the following embodiments do not limit the scope of the present invention.

As shown in fig. 1-11, the embodiment of the present invention provides a novel microcatheter, which is a tubular structure, and comprises a head end 1, a tube body 2, a diffusion stress tube 8 and a needle seat 3, which are sequentially arranged from a far end to a near end, wherein: developing materials are doped in the head end 1, and a developing ring 9 is arranged between the head end 1 and the tube body 2; the pipe body 2 sequentially comprises an outer sleeve layer 4, a braided reinforcing layer 7, a braided layer 6 and an inner liner layer 5 from outside to inside; and the near end of the tube body 2 is fixedly connected with the needle seat 3, and a diffusion stress tube 8 is sleeved at the joint of the near end of the tube body 2 and the needle seat 3.

In one aspect of this embodiment, as shown in fig. 1-3 and 9-11, the outer diameter of the head end 1 gradually increases from the distal end to the proximal end, and the head end 1 adopts a streamlined design to ensure that the head end of the microcatheter extends into the blood vessel of the human body smoothly.

In one aspect of this embodiment, the head end 1 is made of soft polyamide or soft polyurethane, preferably polyether block polyamide, which has the properties of a thermoplastic elastomer due to its unique chemical structure, and the polyether block polyamide is the lightest engineering thermoplastic elastomer, and has no loss of mechanical properties under repeated deformation and is fatigue-resistant, and meanwhile, the polyether block polyamide has precise dimensional stability, so as to ensure that the microcatheter maintains unchanged dimensions under different environmental conditions, and the polyether block polyamide has good resilience and elastic recovery, and when the microcatheter is pulled out from a blood vessel of a human body, the microcatheter can be ensured not to deform.

In one aspect of this embodiment, as shown in fig. 1-3 and 9-11, the developing material is one or more of tungsten powder, barium sulfate, bismuth trioxide, bismuth subcarbonate, and calcium tungstate, the head end is an extruded tube formed by adding developing auxiliary materials to a soft polyether block polyamide material as a base material, and the head end and the tube body are tightly combined together by a welding process.

In one aspect of this embodiment, as shown in fig. 10, the proximal end surface of the head end 1 is lap-welded on the braided layer 6, the braided layer 6 and the inner liner 5 at the distal end of the tube body 2 extend out of the tube body 2, the proximal end surface of the head end 1 is provided with a lapping protrusion 11, the distal end of the tube body 2 is provided with a lapping groove 12 formed by the upper end surface of the braided layer 6 and the side end surface of the outer jacket layer 4, the tower protrusion 11 is connected with the tower groove 12 in a matching manner, and the tower protrusion 11 is connected with the tower groove 12 in a welding manner.

In one aspect of this embodiment, as shown in fig. 1-2 and 10-11, the developing ring 9 is embedded in the head end 1, and the developing ring 9 completely covers the distal end surface of the braid 6, one end of the developing ring 9 is located at the connection between the tower protrusions 11 and the tower grooves 12, the braid 6 is tightly bound to the inner layer by the developing ring 9, and meanwhile, a developing effect is provided, then the extrusion pipe of the developing pipe head 1 is sleeved on the developing ring 9, and the extrusion pipe is wrapped in the developing ring 9 by welding, so that the double developing effect of the head end can be realized, and a good developing effect is provided for an operator.

In one aspect of this embodiment, as shown in fig. 3, 5, 8, and 10, the thickness of the inner liner 5 is 0.008-0.02mm, and while the mechanical strength of the inner liner 5 is ensured, the thickness of the inner liner 5 is controlled within 0.008-0.02mm to ensure the smoothness of the microcatheter extending into the blood vessel of the human body, and the mechanical strength of the inner liner 5 is not enhanced to sacrifice the overall thickness of the microcatheter.

In one aspect of this embodiment, the developing ring 9 is made of platinum-iridium alloy, gold, or platinum, and the platinum-iridium alloy, gold, and platinum can be clearly developed under X-ray, which can help medical practitioners position the microcatheter in the blood vessel.

On the one hand of this embodiment, the material of inner liner 5 is high density polyethylene or polytetrafluoroethylene, and the equal package stamp volume of polyethylene of high density and polytetrafluoroethylene of high density is less, the better characteristics of mechanical strength, and when the inner liner chooseed for use high density polyethylene and high density polytetrafluoroethylene to promote the holistic mechanical strength of microtube, the diameter of guaranteeing the microtube was less so that the microtube smoothly got into human blood vessel.

In one aspect of this embodiment, as shown in fig. 3, 5, 8, and 10, the inner diameter of the inner liner 5 gradually increases from the distal end to the proximal end, the inner diameter of the distal end of the inner liner 5 is 0.41-0.45mm, the inner diameter of the proximal end of the inner liner 5 is 0.48-0.53mm, and the inner liner 5 can provide stable support for a guide wire.

In one aspect of this embodiment, as shown in fig. 2-6 and 10, the braided layer 6 is formed by braiding stainless steel braided wires or nickel titanium braided wires, the braided wires are round wires, flat wires or elliptical wires, and the compliance and the anti-folding ability of the microcatheter can be enhanced by adopting the double-wire braiding.

In one aspect of this embodiment, as shown in fig. 2-6 and 10, the number of braided wires of the braided layer 6 is 16-32, the braided density PPI of the braided layer 6 gradually decreases from the distal end to the proximal end, the braided density PPI of the distal end of the braided layer 6 is 220-280, the braided density PPI of the proximal end of the braided layer 6 is 50-100, and the hardness of the catheter gradually changes.

In one aspect of this embodiment, as shown in FIGS. 2-3, 7-8, and 11, the braided reinforcing layer 7 is disposed at the proximal end of the shaft 2, the braided reinforcing layer 7 has a length of 800-1100mm, and the braided reinforcing layer 7 is not disposed over the entire surface of the braided layer 6 because: the head end of the microcatheter enters the blood vessel of the human body first, so that better flexibility is needed, the flexibility of the local catheter can be reduced to a certain degree by the woven reinforcing layer 7, and in order to avoid the situation that the microcatheter is difficult to enter the blood vessel of the human body, the reinforcing layer 7 is woven to be arranged at the near end of the tube body 2.

In one aspect of this embodiment, as shown in fig. 2-3, 7-8, and 11, the braided reinforcing layer 7 is formed by braiding stainless steel braided wires or nickel-titanium braided wires, the number of braided wires of the braided reinforcing layer 7 is 20-36, a plurality of braided reinforcing wires 10 are horizontally arranged in the braided reinforcing layer 7, the braided reinforcing layer 7 is added to enhance the pushing performance and the twisting performance of the tubular body 2, and meanwhile, the microcatheter has a smaller size to improve the passability of blood vessels, and particularly when lesions occur in highly tortuous side branch parts, the microcatheter of this design has a significant clinical advantage.

In the one hand of this embodiment, as shown in fig. 1, the right-hand member face of diffusion stress pipe 8 passes through the left end face fixed connection of buckle and needle file 3, and needle file 3 expands into the horn mouth with the transparent PC material of stereoplasm with 2 near-end connection ends of little pipe shaft, inserts needle file 3 with it afterwards, then glues with UV ultraviolet curing and is connected it with shaft 2, goes diffusion stress pipe 8 with soft elastomer TPE material, and diffusion stress pipe 8 is connected with needle file 3 through the back-off.

In one aspect of this embodiment, as shown in fig. 9, the hardness of the sheath layer 4 gradually increases from the distal end to the proximal end, the hardness of the sheath layer 4 varies from 30D to 71D, and the hardness of the catheter gradually changes, so that the catheter has a certain flexibility while the micro-catheter anti-bending capability is improved.

In one aspect of this embodiment, as shown in fig. 9, the outer jacket layer 4 is made of a plurality of polyamide, polyurethane and polyolefin materials with different hardness, among the three polymer materials of polyamide, polyurethane and polyolefin, the polyamide has the lowest hardness, and the polyolefin has the highest hardness, so that the hardness gradient effect of the outer jacket layer 4 is realized by the hardness performance of the different materials.

In one aspect of this embodiment, as shown in fig. 9, the outer diameter of the outer sheath 4 gradually increases from the distal end to the proximal end, the outer diameter of the distal end of the outer sheath 4 is 0.05-0.066mm, the inner diameter of the proximal end of the outer sheath 4 is 0.81-0.92mm, and the outer sheath 4 is designed in a streamline structure, which is beneficial for the smooth entry of the microcatheter into the blood vessel of the human body.

In one aspect of this embodiment, the outer surface of the outer jacket layer 4 is coated with a hydrophilic coating, which greatly reduces the coefficient of friction of the entire microcatheter, further enhancing its passage.

The utility model discloses to current little pipe hardly have good size and good physical properties concurrently, can not guarantee from the pipe shaft distal end to the near-end sclerosis gradually, the compliance is good, but the propelling movement performance is not good, rolls over easily and head end shape retentivity is not good, can't get into blood vessel branching position scheduling problem smoothly, the utility model discloses have very strong propelling movement performance, anti bending property and tracking performance, the pipe hardens from the distal end to the near-end gradually simultaneously, can guarantee the compliance and the shape retentivity of distal end like this, ensure that little pipe accurately reachs patient's pathological change position and passes circuitous pathological change blood vessel in the operation process.

While specific embodiments of the microcatheter of the present invention have been described in detail above, it is by way of example only, and the present invention is not limited to the specific embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, variations and modifications in equivalents may be made without departing from the spirit and scope of the invention, which is intended to be covered by the following claims.

Claims

1. The utility model provides a novel microcatheter, is tubular structure, its characterized in that, includes head end (1), shaft of pipe (2), diffusion stress pipe (8) and needle file (3) that set gradually from distal end to near-end, wherein:

developing materials are doped in the head end (1), and a developing ring (9) is arranged between the head end (1) and the pipe body (2);

the pipe body (2) sequentially comprises an outer sleeve layer (4), a woven reinforcing layer (7), a woven layer (6) and an inner liner layer (5) from outside to inside; and

the near-end of pipe shaft (2) with needle file (3) fixed connection, the near-end of pipe shaft (2) with the junction cover of needle file (3) is equipped with diffusion stress pipe (8).

2. The novel microcatheter according to claim 1, wherein the outer diameter of the tip (1) is progressively larger from the distal end to the proximal end.

3. The novel microcatheter according to claim 2, wherein the tip (1) is made of soft polyamide or soft polyurethane.

4. The novel microcatheter of claim 1, wherein the developable material is one or a combination of more of tungsten powder or barium sulfate or bismuth trioxide or bismuth subcarbonate or calcium tungstate.

5. The novel microcatheter according to claim 1, wherein the proximal end face of the tip (1) is lap welded to a braided layer (6) and the braided layer (6) and inner liner layer (5) at the distal end of the shaft (2) extend out of the shaft (2).

6. The novel microcatheter according to claim 1, wherein the visualization ring (9) is embedded in the head end (1) and the visualization ring (9) completely covers the distal end face of the braid (6).

7. The novel microcatheter according to claim 1, wherein the developing ring (9) is made of platinum-iridium alloy or gold or platinum.

8. The novel microcatheter of claim 1, wherein the thickness of the inner liner (5) is 0.008-0.02 mm.

9. The novel microcatheter of claim 8, wherein the inner liner (5) is made of high density polyethylene or polytetrafluoroethylene.

10. The novel microcatheter of claim 1, wherein the inner diameter of the inner liner (5) gradually increases from the distal end to the proximal end, the inner diameter of the distal end of the inner liner (5) is 0.41-0.45mm, and the inner diameter of the proximal end of the inner liner (5) is 0.48-0.53 mm.

11. The novel microcatheter according to claim 1, wherein the braided layer (6) is braided from stainless steel braided wire or nickel titanium braided wire double wire, the braided wire being round wire or flat wire or oval wire.

12. The novel microcatheter of claim 1, wherein the braided layer (6) has 16-32 strands of braided wires, the braided layer (6) has a braid density PPI that tapers from the distal end to the proximal end, the braid density PPI at the distal end of the braided layer (6) is 220-280, and the braid density PPI at the proximal end of the braided layer (6) is 50-100.

13. The novel microcatheter of claim 1, wherein the braided reinforcing layer (7) is provided at the proximal end of the shaft (2), the braided reinforcing layer (7) having a length of 800-1100 mm.

14. The novel microcatheter according to claim 1, wherein the braided reinforcing layer (7) is braided by stainless steel braided wires or nickel titanium braided wires, the number of braided wires of the braided reinforcing layer (7) is 20-36, and a plurality of braided reinforcing wires (10) are horizontally arranged in the braided reinforcing layer (7).

15. The novel microcatheter of claim 1, wherein the proximal end face of the diffusive stress tube (8) is fixedly connected with the distal end face of the needle hub (3) by a snap fit.

16. The novel microcatheter of claim 1, wherein the hardness of the outer jacket layer (4) gradually increases from the distal end to the proximal end, the hardness of the outer jacket layer (4) varying from 30-71D.

17. The novel microcatheter of claim 16, wherein the outer jacket layer (4) is comprised of a plurality of polyamide, polyurethane and polyolefin materials of varying hardness.

18. The novel microcatheter according to claim 1, wherein the outer diameter of the outer sheath (4) gradually increases from the distal end to the proximal end, the outer diameter of the distal end of the outer sheath (4) is 0.05-0.066mm, and the inner diameter of the proximal end of the outer sheath (4) is 0.81-0.92 mm.

19. The novel microcatheter of claim 1, wherein the outer surface of the outer sheath layer (4) is coated with a hydrophilic coating.