CN217612444U - Interventional device for single or combined drug delivery and mounting of stents - Google Patents

Abstract

The utility model discloses an intervention device for releasing drugs and installing a bracket singly or in combination, which comprises a conveying catheter and a plurality of balloon catheters, wherein the balloon catheters comprise balloons and sub-catheters communicated with the balloons; the plurality of sub-catheters are mutually embedded and arranged on the peripheral side of the conveying catheter, a pressurizing cavity communicated with the corresponding saccule is formed by a gap between every two adjacent sub-catheters and a gap between the innermost sub-catheter and the conveying catheter, and the opening parts of the plurality of sub-catheters in the needle seat cavity are arranged in a step shape along the long axis direction of the needle seat cavity; by adopting the intervention device, a plurality of different intervention treatments can be completed through one-time conveying, so that complicated vascular lesion parts can be conveniently dealt with, the operation time and risk are reduced, and the operation cost is reduced; in addition, the opening parts of the plurality of pressurizing cavities in the needle seat cavity are arranged in a step shape, so that the whole structure of the conveying device is more compact.

Description

Interventional device for single or combined drug delivery and mounting of stents

Technical Field

The utility model relates to a cavity expansion apparatus technical field for the intervention type operation especially relates to an intervention device of independent or combination release medicine and installing support.

Background

Vascular stenosis is a common cardiovascular disease, is an important cause and risk factor for ischemic vascular diseases, and currently, vascular stent implantation is one of important techniques for treating vascular stenosis. The treatment method comprises the steps of firstly conveying the saccule to a diseased part, expanding the saccule to enable blood vessels of the diseased part to be stretched to realize pre-expansion, and then conveying the saccule carrying the stent to perform secondary expansion to place the stent. The current balloon expandable stent delivery system can only carry one stent, when facing complex vascular structures, multiple stents or multiple stents may be needed, one stent or one stent may not meet clinical requirements.

In addition, the Drug Coated Balloon (DCB) has the advantages of relatively simple operation, short clinical use double-antibody time, low postoperative bleeding risk rate and the like, provides a new concept for interventional therapy of patients with coronary heart disease, is fully proved particularly in the treatment of ISR lesion and small vessel lesion, and shows a certain application value in coronary artery complex lesions such as bifurcation lesion, acute myocardial infarction lesion, diffuse lesion, chronic occlusive lesion and the like. However, DCB still faces many problems, such as elastic recoil, which may affect the curative effect because DCB alone cannot effectively overcome the elastic recoil of blood vessels, and severe coronary dissection may occur after DCB alone treatment, and a remedial implanted stent is still needed.

In summary, for many patients with different types of angiostenosis, multiple procedures are required, such as DCB treatment at one site and drug stent (DES) treatment at another site. Thus, if a conventional single DES or DCB is used, multiple interventions are required, which can result in prolonged procedure time, longer exposure of the patient to X-rays and contrast agents, increased surgical risk, and increased medical costs.

SUMMERY OF THE UTILITY MODEL

The utility model aims at solving the technical problem of not enough and provide one kind through once carry can accomplish to carry out the independent or combination release medicine and the intervention device of installing support that different intervention formula was treated to many lesions in the blood vessel.

In order to achieve the above object, the utility model discloses an intervention device for releasing drugs and installing a stent singly or in combination, which comprises a conveying catheter and a plurality of balloon catheters, wherein each balloon catheter comprises a balloon and a sub-catheter communicated with the balloon, the balloons are sequentially arranged at intervals at the far end of the conveying catheter along the long axis of the conveying catheter, a needle seat is arranged at the near end of the conveying catheter, a needle seat cavity is arranged in the needle seat, and the conveying catheter and the sub-catheter pass through the needle seat cavity; the sub-catheters are embedded on the outer peripheral side of the conveying catheter, a pressurizing cavity communicated with the corresponding balloon is formed in a gap between every two adjacent sub-catheters and a gap between the innermost sub-catheter and the conveying catheter, the opening parts of the sub-catheters in the needle seat cavity are arranged in a step shape along the long axis direction of the needle seat cavity, and a plurality of pressurizing openings communicated with the pressurizing cavities are further formed in the outer peripheral wall of the needle seat.

Preferably, a plurality of steps of stepped passages are arranged in the needle seat cavity, the diameters of the plurality of steps of stepped passages are gradually reduced from the far end to the near end, the near ends of the sub-catheters are sequentially accommodated in the corresponding stepped passages according to the diameters, and the pressurizing port corresponding to each sub-catheter is arranged in the stepped passage at the adjacent stage of the near end of the sub-catheter.

Preferably, the peripheral wall of the needle base is provided with glue injection holes communicated with the stepped channels at positions corresponding to the stepped channels.

Preferably, the glue injection hole is arranged at the center of the stepped channel.

Preferably, the head at the distal end of the delivery catheter is provided with a rotating drill bit structure.

Preferably, a stent is crimped onto the outer wall of one or more of the balloons.

Preferably, the stent may be any one of a bare stent, a drug eluting stent, and a degradable stent.

Preferably, the outer wall of one or more of the balloons is provided with a drug-containing coating.

Preferably, the drug-containing coating comprises a drug and a drug carrier.

Preferably, the conveying catheters at the front end and the rear end in the saccule are also provided with developing elements.

Compared with the prior art, the utility model discloses intervene device, including carrying the pipe, a plurality of sacculums and needle file, a plurality of sacculums set up the distal end at carrying the pipe, the needle file sets up the near-end at carrying the pipe, for each sacculus configuration an independent pressurization chamber that extends to the needle file intracavity, make independent each other between a plurality of sacculums, each other does not influence, during the operation, fill into the expansion medium through each pressurization mouth to each pressurization intracavity, thereby expand a plurality of sacculums, like this, through once carrying, can accomplish the intervention treatment of a plurality of differences, thereby conveniently deal with complicated vascular pathological change position, reduce operation time and risk, and reduce the operation expense; in addition, the pressurizing cavities of the balloons are mutually nested, and the opening parts of the pressurizing cavities in the needle seat cavity are arranged in a step shape, so that the whole structure of the conveying device is more compact.

Drawings

Fig. 1 is a schematic perspective view of an interventional device according to an embodiment of the present invention.

Fig. 2 is a schematic view of the front plane structure of fig. 1.

Fig. 3 is a longitudinal cross-sectional view of fig. 2 at one of its viewing angles.

Fig. 4 isbase:Sub>A cross-sectional view taken along linebase:Sub>A-base:Sub>A of fig. 2.

Fig. 5 is an enlarged view of a portion Q1 in fig. 3.

Fig. 6 is an enlarged view of a portion Q2 in fig. 3.

Fig. 7 is an enlarged view of a portion Q3 in fig. 3.

Fig. 8 is an enlarged view of a portion Q4 in fig. 3.

Fig. 9 is an enlarged view of a portion Q5 in fig. 3.

Fig. 10 is an enlarged view of a portion Q6 in fig. 3.

Fig. 11 is an enlarged portion of portion F in fig. 2.

Fig. 12 is a sectional view of the needle holder of the embodiment of the present invention at one of the viewing angles.

Fig. 13 is a cross-sectional view of the needle holder of the embodiment of the present invention from another viewing angle.

Fig. 14 is a cross-sectional view of the hub portion of fig. 2 taken along the central axis of the hole.

Detailed Description

In order to explain technical contents, structural features, and objects and effects of the present invention in detail, the following description is given in conjunction with the embodiments and the accompanying drawings.

Referring to fig. 1 to 10, this embodiment discloses an interventional device for releasing a drug and installing a stent alone or in combination, which can be used for interventional surgery of vascular complex lesions. The conveying device comprises a conveying catheter 1 and a plurality of balloon catheters, a guide wire cavity 10 for guide wires to pass through is arranged in the conveying catheter 1, each balloon catheter comprises a balloon 2 and a sub-catheter 3 communicated with the balloon, and a medicine-containing coating is arranged on the outer wall of at least one balloon 2 and/or a support 5 is pressed and held on the outer wall of at least one balloon 2. A plurality of balloons 2 are arranged at the distal end position of the delivery catheter 1 at intervals in sequence along the long axis direction of the delivery catheter 1, and the balloons 2 are used for expanding blood vessels. The proximal end of the delivery catheter 1 is provided with a needle seat 4 for operation, a needle seat cavity 40 is arranged in the needle seat 4, namely, the needle seat 4 is of a hollow structure, and the delivery catheter 1 penetrates through the needle seat cavity 40. The delivery catheter 1 and the sub-catheter 3 pass through the hub cavity 40. The plurality of sub-catheters 3 are embedded on the outer peripheral side of the conveying catheter 1, a pressurizing cavity 30 communicated with the corresponding balloon 2 is formed by a gap between every two adjacent sub-catheters 3 and a gap between the innermost sub-catheter 3 and the conveying catheter 1, the opening parts of the plurality of sub-catheters 3 in the needle seat cavity 40 are arranged in a step shape along the long axis direction of the needle seat cavity 40, and the outer peripheral wall of the needle seat 4 is also provided with a plurality of pressurizing openings 41 respectively communicated with each pressurizing cavity 30. When in use, the inflation port 41 is used to inflate the inflation medium into the inflation lumen 30 connected thereto, thereby expanding the balloon 2 connected to the inflation lumen 30.

In the present embodiment, as shown in fig. 3 to 10, four balloons 2, namely, a balloon 2A, a balloon 2B, a balloon 2C, and a balloon 2D, are disposed at intervals along the axial extension direction of the distal end of the delivery catheter 1, and correspondingly, there are four sub-catheters 3, namely, a sub-catheter 3A, a sub-catheter 3B, a sub-catheter 3C, and a sub-catheter 3D, so that there are also four formed inflation cavities 30, namely, an inflation cavity 30A communicated with the balloon 2A, an inflation cavity 30B communicated with the balloon 2B, an inflation cavity 30C communicated with the balloon 2C, and an inflation cavity 30D communicated with the balloon 2D.

When the vessel intervention type operation treatment is carried out, a conveying device with a corresponding number of balloons 2 can be selected according to the pathological changes, a needle tube is inserted into a pressurizing port 41 on a needle seat 4, so as to inject expanding media such as air, normal saline or similar compressible fluid into a pressurizing cavity 30 to expand the balloons 2, and the expanding pressure is 0.1-20kgf/cm ² Therefore, when the patient faces a complex lesion part, the interventional vasodilation treatment at multiple positions can be completed through one-time conveying, so that the operation time and the operation cost are effectively reduced, and the operation success rate and the experience of doctors and patients are effectively improved. In addition, because the plurality of the inflating cavities 30 of the balloons 2 are nested with each other, and the plurality of the inflating cavities 30 are arranged in a step shape at the opening part 30 of the proximal end of the conveying catheter 1, the whole structure of the conveying device is more compact, and the required balloons 2 are easier to selectively activate. The length of the balloon 2 in this embodiment is not less than 5mm.

Specifically, as shown in fig. 12 and 13, a plurality of steps of stepped passages 42 are arranged in the needle seat cavity 40, the diameters of the plurality of steps of stepped passages 42 are gradually reduced from the distal end to the proximal end, the proximal ends of the plurality of sub-catheters 3 are sequentially accommodated in the corresponding stepped passages 42 according to the diameters, and the pressurizing port 41 corresponding to each sub-catheter 3 is arranged in the stepped passage 42 of the adjacent step of the proximal end of the sub-catheter 3.

In the present embodiment, a five-step channel 42 is disposed in the needle seat cavity 40, and a first step channel 42A, a second step channel 42B, a third step channel 42C, a fourth step channel 42D and a fifth step channel 42E are disposed from the distal end to the proximal end of the needle seat cavity 40, wherein the fifth step channel 42E is used for accommodating the delivery catheter 1, the first step channel 42A is used for accommodating the sub-catheter 3A, the second step channel 42B is used for accommodating the sub-catheter 3B, the third step channel 42C is used for accommodating the sub-catheter 3C, and the fourth step channel 42D is used for accommodating the sub-catheter 3D. Taking sub-catheter 3D as an example, the corresponding pressurizing port 41 is located in the fifth step channel 42E, so that when the expanding medium is injected into the fifth step channel 42 through the pressurizing port 41, the expanding medium enters the pressurizing cavity 30 between the inner wall of sub-catheter 3D and the outer wall of delivery catheter 1 along the fifth step channel 42.

In the above embodiment, the installation and matching of each sub-catheter 3 are more compact and the sub-catheter 3 is prevented from being perforated by the plurality of stepped channels 42 arranged in the needle seat cavity 40.

Further, as shown in fig. 1 to 8 and fig. 12 and 14, in order to effectively ensure the sealing performance and the independence of the respective pressure chambers 30 and avoid mutual interference, a glue injection hole 43 communicated with each stepped channel 42 is respectively arranged on the peripheral wall of the needle holder 4 at a position corresponding to each stepped channel 42. In this embodiment, glue can be injected into each stepped channel 42 through each glue injection hole 43, so that a glue layer P is formed on the outer circumferential surface of the sub-conduit 3 in each stepped channel 42, so that the sub-conduit 3 is tightly combined with the inner wall of the stepped channel 42 to which it belongs, and air leakage is avoided. To achieve a better sealing effect, the glue injection hole 43 is disposed at the center of each stepped channel 42.

In the present embodiment, each glue injection hole 43 respectively passes through the stepped wall of the stepped channel 42 at the position to communicate with the needle holder cavity 40, and each glue injection hole 43 faces the sub-catheter 3 corresponding to the stepped channel 42. When the inflatable balloon is used, because the sub-catheters 3 are mutually nested, after the sealant is injected into the corresponding stepped channels 42 through the sealant injection holes 43, the outer wall of the sub-catheter 3 in each stepped channel 42 is tightly adhered to the inner wall of the corresponding stepped channel 42, so that the expansion medium is prevented from flowing into other inflatable cavities 30 through the gaps between the sub-catheters 3 and the stepped channels 42, the mutual influence of the inflatable cavities 30 and the balloon 2 in the expansion process of the balloon 2 is prevented, and the sealing performance and the independence of the inflatable cavities 30 are effectively ensured. In addition, in this embodiment, the number of the glue injection holes 43 on each step channel 42 is not limited, and may be one or more, as long as the proximal end of the sub-catheter 3 can be sealed with the inner wall of the step channel 42 by injecting the sealing glue through the glue injection holes 43.

Fig. 2 and 11 show that in order to make the delivery catheter 1 move smoothly in the blood vessel, the head at the far end of the delivery catheter 1 is provided with a rotary drill bit structure 12, a through cavity communicated with the guide wire cavity 10 is arranged in the rotary drill bit structure 12, the internal guide wire in the operation reaches the stenosis part of the diseased blood vessel, if the stenosis part is blocked and is not easy to pass through, the delivery catheter 1 can be rotated, and the effect of puncture and passing is achieved.

Preferably, the stent 5 may be any one of a bare stent, a drug eluting stent, and a degradable stent.

Further, the drug-containing coating includes a drug and a drug carrier. The drug carrier can be selected from hydrophilic organic matters, or can be organic matters which are easy to dissolve in water and contain one or more functional groups of hydroxyl, amino, amido, sulfonic acid group, carboxylic acid and ether bond, and can also be selected from one or more of urea, gluconolactone, sorbitol, dipropanolaminohexanephthalein, glucose, fructose, polysaccharide, chitosan with low molecular weight, polyethylene glycol with molecular weight of 4000-8000 and hydrophilic monomer polymer with alkoxy.

In particular, selected from the group consisting of antiproliferative, anti-inflammatory, anti-proliferative, antibacterial, antineoplastic, antimitotic, cytostatic, cytotoxic, anti-osteoporosis, antiangiogenic, anti-restenotic, microtubule-inhibiting, anti-metastatic or antithrombotic drugs including, but not limited to, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine and aminosalicylic acid, acemetacin, escin, aminopterin, antimycosin, diarsenic trioxide, aristolochic acid, aspirin, small base, ginkgol, rapamycin and its derivatives (including zotarolimus, everolimus, bimorphus, 7-O-desmethylrapamycin, temsirolimus, desphamus, and the like, as well as endostatin, angiostatin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, levofloxacin, paclitaxel, docetaxel, hydroxypivalodine, vincristine, vinblastine, neomycin, a-selective inhibitors, particularly, vincristine, a-selective inhibitors, cyclosporin-receptor antagonists, especially cyclosporin a, cyclosporin-a-receptor agonists, and other drugs.

In summary, the conveying and conveying device with the above structure can be combined with the following structures:

a: there are two balloons 2, one of which is a normal balloon 2, for pre-expansion, and then the other balloon 2 is used to mount a drug eluting stent 5 to place the drug eluting stent 5 at the lesion.

B: there are two balloons 2, one of which is a conventional balloon 2 for pre-dilation, and then the other balloon 2 is provided with a drug-containing coating to release the drug.

C: the device is provided with two balloons 2, wherein one balloon 2 is provided with a drug-containing coating, the other balloon 2 is used for installing a drug eluting stent 5, the drug is released from a lesion part with small stenosis degree through the balloon 2 with the drug-containing coating, and the drug eluting stent 5 is arranged at the lesion part with large stenosis degree through the other balloon 2.

D: there are three balloons 2, one of which is a common balloon 2 for pre-dilatation, the other balloon 2 is provided with a drug-containing coating for drug-releasing therapy of a lesion site with a small stenosis degree, and then the other balloon 2 is used for installing a drug-eluting stent 5 for placing the drug-eluting stent 5 at a lesion site with a larger stenosis degree.

E: there are four balloons 2, one of which is a normal balloon 2 for pre-expansion, and the other three balloons 2 are held with drug eluting stents 5 in pressure equalizing manner.

It can be seen that the multi-balloon 2 interventional delivery device having the above-described structure can achieve a plurality of different types of treatment of a plurality of lesion sites by one-time delivery.

In addition, as shown in fig. 3 and 10, in order to monitor the moving position of the delivery catheter 1, the delivery catheter 1 at the front and rear ends in the balloon 2 is further provided with developing elements 6.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the scope of the invention, therefore, the invention is not limited thereto.

Claims (9)

1. The intervention device is characterized by comprising a delivery catheter and a plurality of balloon catheters, wherein the balloon catheters comprise balloons and sub-catheters communicated with the balloons, the outer wall of at least one balloon is provided with a drug-containing coating and/or the outer wall of at least one balloon is pressed and held with a stent, the balloons are sequentially arranged at the far end position of the delivery catheter at intervals along the long axis direction of the delivery catheter, the near end of the delivery catheter is provided with a needle seat, a needle seat cavity is arranged in the needle seat, and the delivery catheter and the sub-catheters pass through the needle seat cavity; the sub-catheters are embedded on the outer peripheral side of the conveying catheter, a pressurizing cavity communicated with the corresponding balloon is formed by a gap between every two adjacent sub-catheters and a gap between the innermost sub-catheter and the conveying catheter, the opening parts of the sub-catheters in the needle seat cavity are arranged in a step shape along the long axis direction of the needle seat cavity, and a plurality of pressurizing ports communicated with the pressurizing cavities are further arranged on the outer peripheral wall of the needle seat.

2. The interventional device for releasing drugs and installing stents individually or in combination according to claim 1, wherein the needle hub cavity is provided with a plurality of stepped passages arranged in a stepped manner, the diameters of the stepped passages are gradually reduced from the distal end to the proximal end, the proximal ends of the sub-catheters are sequentially accommodated in the corresponding stepped passages according to the diameters, and the pressurizing port corresponding to each sub-catheter is arranged in the stepped passage of the adjacent stage of the proximal end of the sub-catheter.

3. The device of claim 2, wherein the outer circumferential wall of the needle holder is provided with a glue injection hole corresponding to each stepped channel, and the glue injection holes are communicated with the stepped channels.

4. The interventional device for releasing drugs and mounting stents either alone or in combination as claimed in claim 3, wherein the glue injection hole is provided at the center of the stepped channel.

5. A drug delivery and stent deployment interventional device, either alone or in combination, as set forth in claim 1, wherein the head at the distal end of the delivery catheter is provided with a rotating drill bit configuration.

6. The interventional device of claim 1, wherein the stent is any one of a bare stent, a drug eluting stent, and a degradable stent.

7. The stent-mounted interventional device of claim 1, wherein the drug-containing coating comprises a drug and a drug carrier.

8. The device of claim 1, wherein the delivery catheter is further provided with visualization elements at the front and rear ends of the delivery catheter.

9. The stent-mounted interventional device for drug delivery alone or in combination of claim 1, wherein the number of balloons is greater than or equal to 2.

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