CN113456990A

CN113456990A - Interventional catheter device

Info

Publication number: CN113456990A
Application number: CN202110869313.0A
Authority: CN
Inventors: 胡猛; 郭栋; 宋进华
Original assignee: Beijing Maidis Medical Technology Co ltd
Current assignee: Beijing Maidis Medical Technology Co ltd
Priority date: 2021-07-30
Filing date: 2021-07-30
Publication date: 2021-10-01
Also published as: WO2023006071A1

Abstract

The invention relates to an interventional catheter device, which can prevent tissues from being injured when the interventional catheter device is placed into a body through a flexible sleeve, can keep an interventional catheter at an interventional target point, and realizes safe, accurate, efficient and easy-to-operate interventional operation.

Description

Interventional catheter device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interventional catheter instrument.

Background

The background art related to the present invention will be described below, but these descriptions do not necessarily constitute the prior art of the present invention.

Interventional Radiology (Interventional Radiology) is an edge subject that has rapidly developed in the late seventies of the twentieth century. Under the guidance of medical imaging equipment, the method is based on imaging diagnostics and clinical diagnostics, combines the principle of clinical therapeutics, and utilizes devices such as catheters, guide wires and the like to diagnose and treat various diseases. Namely: under the guidance of image medicine (X-ray, ultrasonic, CT and MRI), a specially-made catheter or instrument is inserted into a diseased region through a percutaneous puncture way or an original pore canal of a human body to carry out the discipline of diagnostic radiography and treatment or tissue collection, and cytological bacteriology and biochemical examination are carried out.

Interventional radiology provides a new route of administration and surgical methods for modern medical diagnosis and treatment. Compared with the traditional administration route and operation method, the method has the advantages of more direct and effective administration, more convenient and minimally invasive operation. The interventional radiology develops a new treatment way, is simple, convenient and safe, has small wound, few complications and quick response, and has minimal invasion; the repeatability is strong; the positioning is accurate; the curative effect is high, the effect is fast; the complication rate is low; the connection application of various technologies is simple and easy.

Interventional radiology can be divided into interventional diagnostics and interventional therapeutics according to purposes; the method comprises the following steps: vascular interventional radiology (drug infusion; embolization techniques; shaped stents; filter techniques, etc.) and non-vascular radiology (needle biopsy; drainage techniques; foreign body removal; luminal stents, etc.); according to the clinical application range, the method can be divided into tumor interventional radiology, non-tumor interventional radiology, nerve interventional radiology and the like.

Interventional instruments are devices used to perform interventional procedures, such as vascular stent kits, percutaneous needle biopsy kits, radiofrequency ablation kits, tumor embolization kits, and the like. Interventional devices may generally include, but are not limited to, any one or combination of the following: puncture instruments, radio frequency instruments, microwave instruments, particle instruments, implant instruments, sheath instruments, tube instruments, biopsy instruments, and the like. The interventional instrument may include one or more interventional tools, which may be catheters, guidewires, puncture needles, vascular sheaths, balloons, biopsy needles, and the like.

Catheter technology is widely used in interventional radiology. The former catheter instruments are mostly used for establishing the channel of the interventional operation instrument, and most of them do not have the function of special position bending guide (Liyanhao. practical clinical interventional medical science graphic [ M ]. Beijing: scientific publishing agency, 2012.).

At present, some catheter instruments clinically used in blood vessels and organs of a human body need to be bent at a certain angle at a specific position after entering the human body, and guide an interventional operation instrument such as a puncture needle, a guide wire and the like after being bent. Plastic catheter instruments, such as the RUPS-100 puncture assembly manufactured by COOK, usa, metal catheter instruments, have a position-specific curved guide structure to achieve a corresponding guiding function.

During an intervention, sometimes to guide the intervention, it is necessary for the distal end of the catheter instrument to abut against the target site of the intervention so that the intervention instrument passes through the catheter instrument, extends out of the distal end of the catheter instrument, and is accurately introduced at the target site of the intervention.

To prevent the distal end of the catheter instrument from injuring the tissue being passed through during the course of passing through the interventional approach to the target site of the intervention, the exterior of the catheter may be provided with a flexible sheath that extends beyond the distal end of the catheter so that the distal end of the catheter is covered by the flexible sheath to prevent it from injuring the surrounding tissue.

In interventional procedures, particularly those involving long and tortuous interventional procedures, it is necessary to bend an interventional instrument at a certain angle in a blood vessel through a catheter instrument before performing the intervention on the blood vessel or tissue. When the distal end of the flexible sleeve sleeved outside the catheter leans against the intervention target point, the intervention process cannot be kept at the intervention target point due to the flexibility of the flexible sleeve, errors such as the puncture failure of a jump needle or the change of the intervention direction and the like often occur in the intervention process, the operation operator is caused to have very large operation difficulty, the operator can only depend on the operation to support the catheter outside the body or press the specific part of the human body, the operation difficulty of the operator is greatly increased, and the operation application is limited.

For example, in transjugular intrahepatic puncture surgery, it is critical that the surgical puncture be successful to keep the catheter instrument at the puncture target on the hepatic vein wall (Lihao. practical clinical intervention diagnostics diagram [ M ]. Beijing: scientific Press, 2012.). However, the current puncture assembly cannot effectively solve the problem (the state of development and standardization of the jugular intrahepatic portosystemic shunt technology in China, China interventional radiology electronic journal, 2013,1 (2)).

Therefore, there is a need for a catheter device that can prevent injury to surrounding tissues and remain at the target site during the intervention to prevent needle jump failure or intervention direction variation errors during the intervention.

Disclosure of Invention

In view of this, the embodiment of the present invention provides an interventional catheter device, so as to solve one or more of the problems of easy damage to the surrounding tissues, difficulty in maintaining at the interventional target, difficulty in operation, poor accuracy, and the like in the existing interventional operation, and achieve an interventional operation that is easier to operate and more accurate and effective.

According to one aspect of the present invention, there is provided an interventional catheter device, comprising: a guide tube; the flexible sleeve is sleeved outside the guide pipe; the flexible sleeve and the guide tube are relatively movable such that the distal end of the flexible sleeve extends beyond the distal end of the guide tube or the distal end of the guide tube extends beyond the distal end of the flexible sleeve.

Further, the distal end of the flexible sleeve is provided with a necking part, the inner diameter of the necking part is smaller than the outer diameter of the guide tube, the necking part is provided with a weakening part which is easy to break, when the interventional catheter device is abutted to an interventional target point, the weakening part can be broken by enabling the guide tube to move towards the distal end relative to the flexible sleeve, and therefore the guide tube extends out of the distal end of the flexible sleeve.

Further, the weakened portion extends to a distal opening of the flexible sleeve.

Further, the weakened portion extends in a longitudinal direction of the flexible sheath, in a linear manner or a spiral manner, to the distal opening of the flexible sheath.

Further, the weakened portions are intermittent score lines or indentations.

Further, the weakened portion is provided on an inner surface or an outer surface of the weakened portion.

Furthermore, the inner diameter of the necking part is 0.05 mm-1 mm smaller than the outer diameter of the guide pipe.

Further, the material of the flexible sleeve includes, but is not limited to, one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, and high density polyethylene.

Further, the material of the guide tube includes but is not limited to one or more of stainless steel and nickel titanium alloy.

Further, the thickness specifications of the guide tube include, but are not limited to: 13G, 14G, 15G and 16G, and the length of the guide tube is 42 cm-57 cm.

Furthermore, the inner diameter of the flexible sleeve is 0.1-2 mm larger than the outer diameter of the guide tube.

Further, the interventional catheter device comprises a connector by which the proximal end of the guide tube is connected with the proximal end of the flexible sleeve and by which the guide tube and the flexible sleeve can be relatively moved.

Further, the connecting mode of the connecting piece is a thread mode, a buckling mode or an adhesion mode.

According to one aspect of the present invention there is provided an interventional instrument comprising an interventional catheter instrument as described above.

In conclusion, the interventional catheter device provided by the invention can prevent surrounding tissues from being injured, can keep the catheter device at the interventional target point in the interventional process, so as to prevent the error of needle skipping and puncture failure or the error of change of the interventional direction in the interventional process, is easier to operate, more accurate and more effective, and solves the technical problems in the prior art.

Drawings

The features and advantages of the present invention will become more readily appreciated from the detailed description section provided below with reference to the drawings, in which:

FIG. 1 is a schematic assembled view of an interventional catheter device and introducer needle in accordance with an embodiment of the invention;

FIG. 2 is a schematic view of a guide tube of an embodiment of the present invention;

FIG. 3 is a schematic view of a flexible sleeve of an embodiment of the present invention;

FIG. 4 is a schematic view of the assembly of a guide tube and a flexible sleeve of an embodiment of the invention;

FIG. 5 is a schematic view of the guiding tube and flexible sheath of an embodiment of the present invention in a position during an interventional approach to an interventional target;

FIG. 6 is a schematic view of the guiding cannula and flexible sheath of the embodiment of the present invention in the state of performing the puncture guide;

FIG. 7 is a schematic view of the guiding cannula and flexible sheath of an embodiment of the present invention in a state during exit through an interventional approach after performing a puncture guide;

FIG. 8 is a schematic view of a distally necked formed flexible sleeve of an embodiment of the present invention;

FIG. 9 is a schematic view of a necked-down portion of a flexible sleeve according to an embodiment of the present invention;

FIG. 10 is a schematic view of the guiding tube and flexible sheath of an embodiment of the present invention in a position during an interventional approach to an interventional target;

FIG. 11 is a schematic view of the state of the guide tube and the flexible sheath for performing the puncture guide according to the embodiment of the present invention;

FIG. 12 is a schematic view of the guide tube and flexible sheath of an embodiment of the present invention during withdrawal through an interventional approach after insertion guidance has been performed.

Detailed Description

Exemplary embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The description of the exemplary embodiments is for purposes of illustration only and is not intended to limit the invention, its application, or uses.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this application, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this disclosure, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "distal" as used herein refers to the side away from the operator; accordingly, "proximal" is the side opposite "distal" from "proximal" to "distal".

FIG. 1 is a schematic assembled view of an interventional catheter device and introducer needle in accordance with an embodiment of the invention. In an embodiment of the invention, as shown in fig. 1, the catheter device 1 may comprise a guide tube 11 and a flexible sheath 12 to provide a guiding guide for the puncture needle 2. The catheter device 1 may be linear or curved depending on the clinical requirements, for example curved for transjugular intrahepatic puncture procedures.

FIG. 2 is a schematic view of a guide tube of an embodiment of the present invention. In the present embodiment, the material of the guiding tube 11 may be one or more of stainless steel, nitinol, and the like. Depending on clinical needs, the thickness specifications of the guide tube 11 may include, but are not limited to: 13G, 14G, 15G, 16G, etc. (G is an abbreviation for GAUGE, a unit of measure of length for diameter originating in north america); the length specification can be 42 cm-57 cm.

As shown in fig. 2, the distal end of the guide tube 11 may be of a beveled blade type, and may be used for puncturing and for piercing an interventional target site to abut against the interventional target site.

As shown in FIG. 2, the distal side of the guide tube 11 may be formed with one or more bends, depending on the clinical needs. In one embodiment of the present invention, the distal end of the guiding tube 11 is a curved oblique blade type, and can be bent 10 to 80 degrees, for example, 60 degrees, at a distance of 0.5 to 12cm from the tip of the oblique blade.

FIG. 3 is a schematic view of a flexible sleeve of an embodiment of the present invention. In embodiments of the present invention, the material of the flexible sleeve 12 may include, but is not limited to, one or more of Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12(PA12), block polyether amide elastomer (Pebax), High Density Polyethylene (HDPE), and the like.

FIG. 4 is a schematic view of the assembly of the guide tube and flexible sleeve of an embodiment of the present invention. In the embodiment of the present invention, as shown in fig. 4, the flexible sleeve 12 may be sleeved outside the guiding tube 11, and the inner diameter thereof may be 0.1mm to 2mm larger than the outer diameter of the guiding tube 11. The guide tube 11 and the flexible sleeve 12 are relatively movable such that the distal end of the guide tube 11 may extend beyond the distal end of the flexible sleeve 12, or the distal end of the flexible sleeve 12 may extend beyond the distal end of the guide tube 11 (as shown in fig. 4).

In the embodiment of the present invention, the proximal end of the flexible sheath 12 can be connected to the proximal end of the guide tube 11 by a connector 13 in a threaded, snap-fit or adhesive manner, and the flexible sheath 12 can be moved relative to the guide tube 12 by the connector 13. As shown in fig. 1 or 4, the flexible sheath 12 and the proximal end of the guide tube 11 are threadedly connected by a connector 13.

In the puncture surgery of the embodiment of the invention, the catheter instrument 1 comprising the guide tube 11 and the flexible sleeve 12 firstly enters the body to reach the puncture target point through the intervention ways such as the skin or the organ cavity and the like. FIG. 5 is a schematic view of the guiding tube and flexible sheath of the embodiment of the present invention in the process of reaching the target site through the intervention path. As shown in FIG. 5, in the process, the flexible sleeve 12 is sleeved outside the guiding tube 11, and the distal end of the flexible sleeve 12 extends 2-3 mm beyond the distal beveled edge of the guiding tube 11 to prevent the distal beveled edge from damaging the passing tissue.

In the puncture surgery of the embodiment of the invention, after the distal end of the catheter apparatus 1 reaches the puncture target point, the guide tube 11 and the flexible sleeve 12 can be relatively moved, so that the distal end of the guide tube 11 extends beyond the distal end of the flexible sleeve 12, and the distal end of the guide tube 11 can abut against the puncture target point and be immobilized, thereby implementing puncture guidance. FIG. 6 is a schematic view of the state of the guide tube and the flexible sheath for performing the puncture guide according to the embodiment of the present invention.

In the puncture operation of the embodiment of the present invention, when the catheter device 1 is to be withdrawn through the interventional route after performing the puncture guide, the guide tube 11 and the flexible sheath 12 may be relatively moved, so that the distal end of the flexible sheath 12 extends beyond the distal end bevel edge of the guide tube 11, thereby preventing the distal end bevel edge from injuring the tissue passed therethrough. FIG. 7 is a schematic view of the guiding cannula and flexible sheath of an embodiment of the present invention during withdrawal through an interventional approach after insertion guidance.

In interventional diagnosis and treatment, the distal end of the catheter instrument can be subjected to the resistance action of tissues and organs to pass through in the process of reaching an interventional target point through an interventional path, particularly in the process of interventional operation with long and tortuous interventional path.

To solve the technical problem, in the embodiment of the present invention, the distal end of the flexible sheath 12 may be subjected to a necking process to form a necking portion 121, the necking portion 121 may be tapered, and the inside diameter of the necking portion may be smaller than the outside diameter of the guiding tube 11 by 0.05mm to 1mm after the forming. FIG. 8 is a schematic view of a distally necked formed flexible sleeve of an embodiment of the present invention.

Because the inner diameter of the distal end formed by the necking part of the flexible sleeve 12 is smaller than the outer diameter of the distal end of the guide tube 11, in the process that the catheter instrument 1 reaches an intervention target point through an intervention way, the flexible sleeve 12 cannot move towards the proximal end relative to the guide tube 11 even under the resistance action of passing tissues and organs, so that the guide tube 11 cannot extend out of the distal end of the flexible sleeve 12, and the passing tissues are injured.

Further, FIG. 9 is a schematic view of a necked-down portion of a flexible sleeve according to an embodiment of the present invention. In an embodiment of the present invention, the reduced portion 121 of the flexible sleeve 12 may be provided with a weakened portion 1211 which is easily broken, as shown in fig. 9. The weakened portion 1211 may extend to the distal opening of the flexible sleeve 12. The weakened portion 1211 may be an intermittent score line or indentation that may extend linearly or helically along the longitudinal direction of the flexible sleeve 12 to its distal opening. The weakened portion 1211 may be provided on an inner surface or an outer surface of the throat portion 121. When the weakened portion 1211 is provided on the outer surface of the constricted portion 121, a depression may be formed on the outer surface, which may cause irritation to the blood vessel wall and may also affect the blood flow, thereby increasing the possibility of forming a thrombus. Thus, preferably, the weakened portion 1211 is provided on the inner surface of the throat portion 121.

The weakened portion 1211 is configured such that when the guide tube 11 is advanced distally relative to the flexible sheath 12 with a force greater than the resistance force applied when the catheter device 1 is abutted against the target site of intervention, the guide tube 11 can break the weakened portion 121 to extend out of the distal opening of the flexible sheath 12. In one embodiment of the present invention, the weakened portion 121 is a longitudinal indentation 1mm wide.

Therefore, in the puncture surgery of the embodiment of the invention, the guide tube 11 and the flexible sleeve 12 enter the body to reach the puncture target point through the skin or the interventional approaches such as organ cavity and the like. FIG. 10 is a schematic view of the guiding tube and flexible sheath of an embodiment of the present invention in a position during an interventional approach to an interventional target; as shown in FIG. 10, in the process, the flexible sleeve 12 is sleeved outside the guide tube 11, and the reduced part of the flexible sleeve 12 extends 2-3 mm beyond the distal bevel edge of the guide tube 11 to prevent the distal bevel edge from damaging the passing tissue.

In the puncture surgery of the embodiment of the invention, after the distal end of the catheter device 1 reaches the puncture target point, an acting force larger than the resistance force can be applied to push the guide tube 11 distally relative to the flexible sleeve 12, so that the guide tube 11 breaks the weakened part 121 and extends out of the distal opening of the flexible sleeve 12 by 2-3 mm, and thus, the distal inclined blade of the guide tube 11 can penetrate into the puncture target point, so that the guide tube can be always kept at the puncture target point in the puncture process, and puncture guide is provided for the puncture needle 2. The puncture needle 2 can then be inserted through the catheter instrument 1 to puncture the target puncture site. FIG. 11 is a schematic view showing the state of the guide tube and the flexible sheath when the puncture guide is performed according to the embodiment of the present invention.

In the embodiment of the invention, after the puncture of the puncture needle 2 is finished, the guide tube 11 can be pulled back towards the near end relative to the flexible sleeve 12, so that the inclined blade at the far end of the guide tube 11 retracts into the opening at the far end of the flexible sleeve 12 by 3-5 mm. Thereafter, the guide tube 11 and the flexible sheath 12 are removed along the original interventional approach. Since the distal beveled edge of the guide tube 11 has been retracted into the distal opening of the flexible sheath 12, no injury is caused to the tissue passing therethrough. And in the process of withdrawing the catheter instrument 1, the direction of the resistance action borne by the flexible sleeve 12 is towards the far end direction, so that the flexible sleeve 12 cannot move towards the near end relative to the guide tube 11, and the far end of the guide tube 11 cannot extend out of the far end of the flexible sleeve 12 to damage the tissues. FIG. 12 is a schematic view of the guide tube and flexible sheath of an embodiment of the present invention during withdrawal through an interventional approach after insertion guidance has been performed.

In an embodiment of the present invention, an interventional instrument may be provided, which may comprise an interventional catheter instrument as described above.

The interventional catheter device provided by the embodiment of the invention can prevent surrounding tissues from being injured, and can be kept at an interventional target point in a blood vessel or a tissue in the interventional process, so that a stable and reliable guide structure is built for an operator to guide puncture or interventional device implantation. The interventional catheter instrument has the advantages of simple structure and process, low cost, good operability, high efficiency and safety, and can meet the requirement of an operator on accurate guiding during bending puncture.

In summary, the above embodiments describe the interventional catheter device in detail, and it is understood that the present invention includes but is not limited to the above embodiments, and any modifications made on the above embodiments are within the scope of the present invention. One skilled in the art can take the contents of the above embodiments to take a counter-measure.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the precise embodiments described and illustrated herein, and that various changes may be made therein by those skilled in the art without departing from the scope of the invention as defined in the appended claims, all such changes as fall within the scope of the invention.

While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the invention.

It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. An interventional catheter device, comprising:

a guide tube;

the flexible sleeve is sleeved outside the guide pipe;

the flexible sleeve and the guide tube are relatively movable such that the distal end of the flexible sleeve extends beyond the distal end of the guide tube or the distal end of the guide tube extends beyond the distal end of the flexible sleeve.

2. The interventional catheter device of claim 1, wherein the distal end of the flexible sleeve is provided with a necked-down portion having an inner diameter smaller than an outer diameter of the guide tube and the necked-down portion is provided with a weakened portion susceptible to breakage, wherein when the interventional catheter device is abutted against an interventional target site, moving the guide tube distally relative to the flexible sleeve breaks the weakened portion such that the guide tube extends beyond the distal end of the flexible sleeve.

3. The interventional catheter device of claim 2, wherein the weakened portion extends to a distal opening of the flexible sheath.

4. The interventional catheter device of any one of claims 2-3, wherein the weakened portion extends longitudinally of the flexible sheath, linearly or helically to the distal opening of the flexible sheath.

5. The interventional catheter device of any one of claims 2-4, wherein the weakened portions are intermittent score lines or indentations.

6. The interventional catheter device of any one of claims 2-5, wherein the weakened portion is disposed on an inner or outer surface of the weakened portion.

7. An interventional catheter device according to any of claims 2-6, wherein the inner diameter of the reduced portion is 0.05mm to 1mm smaller than the outer diameter of the guide tube.

8. The interventional catheter device of any one of claims 1-7, wherein the material of the flexible sheath includes, but is not limited to, one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, high density polyethylene.

9. The interventional catheter device of any one of claims 1-8, wherein the material of the guide tube includes, but is not limited to, one or more of stainless steel, nitinol.

10. The interventional catheter device of any one of claims 1-9, wherein the gauge of the guide tube includes, but is not limited to: 13G, 14G, 15G and 16G, and the length of the guide tube is 42 cm-57 cm.

11. The interventional catheter device of any of claims 1-10, wherein the flexible sheath has an inner diameter that is 0.1mm to 2mm greater than the outer diameter of the guide tube.

12. The interventional catheter device of any one of claims 1-11, comprising a connector by which a proximal end of the guide tube is connected with a proximal end of the flexible sleeve and by which the guide tube and the flexible sleeve are relatively movable.

13. The interventional catheter device of claim 12, wherein the connector is attached by a threaded, snap-fit, or adhesive means.

14. An interventional instrument, characterized in that it comprises an interventional catheter device according to any one of claims 1-13.