WO2023006071A1

WO2023006071A1 - Interventional catheter instrument

Info

Publication number: WO2023006071A1
Application number: PCT/CN2022/108986
Authority: WO
Inventors: 胡猛; 郭栋
Original assignee: 北京迈迪斯医疗技术有限公司
Priority date: 2021-07-30
Filing date: 2022-07-29
Publication date: 2023-02-02
Also published as: CN113456990A

Abstract

The present invention relates to an interventional catheter instrument. By means of a flexible sheath, not only can damage to tissue passed when the interventional catheter instrument is inserted into a body be prevented, but an interventional catheter can also be kept at an interventional target site, thereby achieving a safe, precise, efficient and easy-to-operate interventional operation.

Description

Interventional Catheter Devices

technical field

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

Background technique

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 is a marginal subject that developed rapidly in the late 1970s. Under the guidance of medical imaging equipment, it is based on imaging diagnostics and clinical diagnostics, combined with the principles of clinical therapeutics, and uses catheters, guide wires and other equipment to diagnose and treat various diseases. That is: under the guidance of imaging medicine (X-ray, ultrasound, CT, MRI), through the percutaneous puncture or through the original orifice of the human body, a special catheter or instrument is inserted into the lesion for diagnostic imaging and treatment. Or tissue collection, cytology, bacteriology and biochemical examination.

Interventional radiology provides new drug delivery routes and surgical methods for modern medical diagnosis and treatment. Compared with traditional routes of drug administration and surgical methods, it is more direct, effective, simpler and minimally invasive. Interventional radiology has opened up a new way of treatment, and it is simple, safe, less traumatic, less complications, quick effect, minimally invasive; strong repeatability; accurate positioning; high curative effect, quick effect; low incidence of complications; The connection and application of multiple technologies is simple and easy.

According to the purpose, interventional radiology can be divided into interventional diagnostics and interventional therapy; according to technology, it can be divided into: vascular interventional radiology (drug infusion; embolization technology; formed stent; filter technology, etc.) and non-vascular interventional radiology (puncture biopsy ; drainage technology; foreign body removal; cavity stent, etc.); according to the scope of clinical application, it can be divided into tumor interventional radiology, non-tumor interventional radiology, neurological interventional radiology, etc.

Interventional devices are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional devices generally include but are not limited to any of the following or their combination: puncture devices, radio frequency devices, microwave devices, particle devices, implant devices, sheath devices, tube devices, biopsy devices, etc. . An interventional device may include one or more interventional tools, which may be catheters, guide wires, puncture needles, vascular sheaths, balloons, biopsy needles, and the like.

Catheter technology is widely used in interventional radiology. In the past, catheter devices were mostly used to establish channels for interventional surgical devices, and most of them did not have the function of bending and guiding at specific positions (Li Yanhao. Practical Clinical Interventional Diagnosis Diagnosis [M]. Beijing: Science Press, 2012.).

At present, some of the catheter devices clinically used in human blood vessels and organs need to be bent at a certain angle at a specific position after entering the human body, and guide puncture needles, guide wires and other interventional surgical devices after bending. For example, the RUPS-100 puncture assembly plastic catheter device and metal catheter device produced by COOK in the United States have a specific position bending guide structure to realize the corresponding guiding function.

During the intervention process, sometimes in order to achieve guidance for the intervention, it is necessary for the distal end of the catheter device to abut against the intervention target, so that the intervention device passes through the catheter device, extends out of the distal end of the catheter device, and is accurately positioned at the intervention target. Intervene.

In order to prevent the distal end of the catheter instrument from causing damage to the tissue it passes through the interventional approach to the intervention target, a flexible sleeve can be provided on the outside of the catheter, and the flexible sleeve extends beyond the distal end of the catheter so that the distal end of the catheter Covered by a flexible sleeve to prevent it from injuring surrounding tissue.

In interventional surgery, especially the interventional surgery with long and tortuous access, it is necessary for the interventional device to bend a certain angle in the blood vessel through the catheter device before performing blood vessel or tissue intervention. When the distal end of the flexible sheath placed outside the catheter abuts against the intervention target, due to the flexibility of the flexible sheath, it cannot be kept at the intervention target during the intervention process, often resulting in skipped needle insertion during the intervention. Mistakes on the surface or changes in the direction of intervention have caused great difficulty for the operator. At present, the operator can only rely on the support of the catheter outside the body or pressing on a specific part of the human body, which greatly increases the difficulty of the operation for the operator. Limitations surgical application.

For example, in transjugular vein intrahepatic puncture, keeping the catheter device on the hepatic vein wall at the puncture target is the key to successful puncture (Li Yanhao. Practical Clinical Interventional Diagnosis Diagnosis [M]. Beijing: Science Publishing Society, 2012.). However, the current puncture components cannot effectively solve this problem (Chu Jianguo, The development status and standardization of transjugular intrahepatic portosystemic shunt technology in China, Chinese Electronic Journal of Interventional Radiology, 2013, 1(2)).

Therefore, there is an urgent need for a catheter device that can prevent damage to the surrounding tissues and can also be kept at the intervention target point during the intervention, so as to prevent the occurrence of missed needle puncture or the occurrence of intervention direction during the intervention. variable error.

Contents of the invention

In view of this, an embodiment of the present invention provides an interventional catheter device to solve one of the problems in the above-mentioned existing interventional surgery, which are easy to damage the surrounding tissue, difficult to maintain at the interventional target, difficult to operate, and poor in accuracy. or more, to achieve easier operation, more accurate and effective interventional surgery.

According to one aspect of the present invention, the present invention provides an interventional catheter device, which is characterized in that it includes: a guide tube; a flexible sleeve, the flexible sleeve is set outside the guide tube; the flexible sleeve and the guide tube Relatively movable such that the distal end of the flexible sheath 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 sheath.

Further, the distal end of the flexible sleeve is provided with a constricted part, the inner diameter of the constricted part is smaller than the outer diameter of the guide tube, and the constricted part is provided with a weakened part that is easy to break, when the intervention catheter Moving the guide tube distally relative to the flexible sheath breaks the weakened portion when the instrument is positioned against the interventional target, such that the guide tube extends beyond the distal end of the flexible sheath.

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

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

Further, the weakened portion is intermittent scoring lines or indentations.

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

Further, the inner diameter of the constricted part is 0.05mm-1mm smaller than the outer diameter of the guide tube.

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

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

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

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

Further, the interventional catheter device includes a connecting piece through which the proximal end of the guide tube is connected to the proximal end of the flexible sheath, and the guiding tube and the flexible sheath can be connected through the connecting piece relatively mobile.

Further, the connection method of the connector is a threaded method, a buckle method or an adhesive method.

According to one aspect of the present invention, the present invention provides an interventional device, which includes the above-mentioned interventional catheter device.

To sum up, the interventional catheter device according to the present invention can not only prevent damage to the surrounding tissue it passes through, but also keep the catheter device at the intervention target point during the intervention process, so as to prevent the occurrence of missed needle puncture during the intervention process. Errors caused by mistakes or changes in the direction of intervention are easier to operate, more accurate and effective, thereby solving the technical problems existing in the prior art.

Description of drawings

The features and advantages of the present invention will become more comprehensible through the following detailed description provided with reference to the accompanying drawings, in which:

Fig. 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention;

Fig. 2 is the schematic diagram of the guiding tube of the embodiment of the present invention;

3 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention;

Fig. 4 is a schematic diagram of assembly of a guide tube and a flexible sleeve according to an embodiment of the present invention;

Fig. 5 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach;

Fig. 6 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention;

Fig. 7 is a schematic diagram of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance;

Fig. 8 is a schematic diagram of a flexible sleeve formed with a distal constriction according to an embodiment of the present invention;

Fig. 9 is a schematic diagram of the shrinkage part of the flexible sleeve according to the embodiment of the present invention;

Fig. 10 is a schematic diagram of the state of the guide tube and the flexible sleeve in the process of reaching the intervention target through the intervention approach according to the embodiment of the present invention;

Fig. 11 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention;

Fig. 12 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

Detailed ways

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 the purpose of illustration only, and in no way limits the invention and its application or usage.

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings. It should be noted that all the drawings are in a very simplified form and use imprecise scales, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention.

As used herein, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The "far end" and "far side" mentioned in the present invention refer to the side away from the operator; correspondingly, "proximal end" and "near side" are opposite to "far end" and "far side" side.

Fig. 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention. In the embodiment of the present invention, as shown in FIG. 1 , the catheter device 1 may include a guide tube 11 and a flexible sheath 12 to provide guidance for the puncture needle 2 . According to clinical needs, the catheter device 1 can be straight or curved, for example, the curved one can be used for intrahepatic puncture through the jugular vein.

Fig. 2 is a schematic diagram of a guide tube according to an embodiment of the present invention. In the embodiment of the present invention, the material of the guide tube 11 may be one or more materials including but not limited to stainless steel, nickel-titanium alloy and the like. According to clinical needs, the thickness specifications of the guide tube 11 can include but are not limited to: 13G, 14G, 15G, 16G, etc. It is 42cm～57cm.

As shown in FIG. 2 , the distal end of the guide tube 11 can be bevelled, which can be used for puncturing, or for piercing into the intervention target so as to abut against the intervention target.

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

Fig. 3 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention. In the embodiment of the present invention, the material of the flexible sleeve 12 may include but not limited to polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12 (PA12), block One or more of polyetheramide elastomer (Pebax), high-density polyethylene (HDPE), etc.

Fig. 4 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to the embodiment of the present invention. In the embodiment of the present invention, as shown in FIG. 4 , the flexible sleeve 12 can be sleeved on the outside of the guide tube 11 , and its inner diameter can be 0.1 mm to 2 mm larger than the outer diameter of the guide tube 11 . The guide tube 11 and the flexible sheath 12 can move relative to each other, so that the distal end of the guide tube 11 can extend beyond the distal end of the flexible sheath 12, or the distal end of the flexible sheath 12 can extend beyond the distal end of the guide tube 11 (as shown in Figure 4 shown).

In the embodiment of the present invention, the proximal end of the flexible sheath 12 can be connected with the proximal end of the guide tube 11 through the connecting piece 13 in a threaded, buckled or adhesive manner, and the flexible sheath 12 can be opposite to the guiding tube 12 through the connecting piece 13 move. As shown in FIG. 1 or FIG. 4 , the flexible sheath 12 and the proximal end of the guide tube 11 are threadedly connected through the connecting piece 13 .

In the puncture operation of the embodiment of the present invention, the catheter device 1 including the guide tube 11 and the flexible sheath 12 first enters the body through the skin or through an organ cavity to reach the puncture target. Fig. 5 is a schematic view of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach. As shown in Figure 5, during this process, the flexible sleeve 12 is sleeved outside the guide tube 11, and the distal end of the flexible sleeve 12 extends beyond the distal beveled edge of the guide tube 11 by 2 to 3 mm to prevent the distal beveled edge from Injury to the tissue it passes through.

In the puncture operation of the embodiment of the present invention, when the distal end of the catheter instrument 1 reaches the puncture target, the guide tube 11 and the flexible sheath 12 can be moved relatively so that the distal end of the guide tube 11 extends beyond the distal end of the flexible sheath 12, Therefore, the distal end of the guide tube 11 can be fixed against the puncture target to implement puncture guidance. Fig. 6 is a schematic view of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.

In the puncture operation of the embodiment of the present invention, when the catheter instrument 1 is to be withdrawn through the interventional approach after implementing puncture guidance, the guide tube 11 and the flexible sheath 12 can be relatively moved so that the distal end of the flexible sheath 12 extends beyond the end of the guide tube 11 The distal bevel to prevent the distal bevel from injuring the passing tissue. Fig. 7 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

In interventional diagnosis and treatment, when the distal end of the catheter device reaches the intervention target through the interventional route, especially the interventional operation with a long and tortuous interventional route, it will be affected by the resistance of the tissues and organs it passes through. Due to the flexibility of the flexible sleeve , often causes the flexible sheath to move proximally relative to the guide tube, causing the distal end of the guide tube to extend beyond the distal end of the flexible sheath, thereby injuring the passing surrounding tissue.

In order to solve this technical problem, further, in the embodiment of the present invention, the distal end of the flexible sleeve 12 can be necked and formed to form a necked part 121, and the necked part 121 can be tapered. After molding, the necked part The inner diameter may be smaller than the outer diameter of the guide tube 11 by 0.05 mm to 1 mm. Fig. 8 is a schematic diagram of a flexible sleeve formed with a distal constriction according to an embodiment of the present invention.

Since the inner diameter of the distal end of the flexible sheath 12 is smaller than the outer diameter of the distal end of the guide tube 11, the flexible sheath 12 is affected by the passing tissue, Due to the resistance of the organ, the guide tube 11 will not move proximally relative to the guide tube 11, so that the guide tube 11 will not protrude from the distal end of the flexible sheath 12, thereby damaging the passing tissues.

Further, Fig. 9 is a schematic view of the necking part of the flexible sleeve according to the embodiment of the present invention. In the embodiment of the present invention, a weakened portion 1211 that is easy to break can be provided on the constricted portion 121 of the flexible sleeve 12 , as shown in FIG. 9 . The weakened portion 1211 may extend to the distal opening of the flexible sheath 12 . The weakened portion 1211 may be an intermittent score line or indentation, and may extend to the opening of the distal end of the flexible sheath 12 in a linear or helical manner along the longitudinal direction of the flexible sheath 12 . The weakened portion 1211 can be disposed on the inner surface or the outer surface of the constriction portion 121 . When the weakened portion 1211 is disposed on the outer surface of the constricted portion 121 , a depression may be formed on the outer surface, which will stimulate the blood vessel wall and affect the blood flow, thereby increasing the possibility of thrombus formation. Therefore, preferably, the weakened portion 1211 is disposed on the inner surface of the constricted portion 121 .

The weakened part 1211 makes it possible for the guide tube 11 to destroy the weakened part 121 and stretch out the flexible part 121 when a force greater than the above-mentioned resistance is applied and the guide tube 11 is pushed distally relative to the flexible sheath 12 when the catheter device 1 abuts against the intervention target point. The distal end of the cover 12 is open. In one embodiment of the present invention, the weakened portion 121 is a longitudinal indentation with a width of 1 mm.

Therefore, in the puncture operation in the embodiment of the present invention, the guide tube 11 and the flexible sheath 12 first enter the body to reach the puncture target through the skin or the organ cavity. Fig. 10 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention approach; as shown in Fig. 10, during this process, the flexible sleeve 12 is sleeved outside the guide tube 11, The constricted portion of the flexible sheath 12 extends beyond the distal beveled edge of the guide tube 11 by 2-3 mm to prevent the distal beveled edge from injuring the passing tissue.

In the puncture operation of the embodiment of the present invention, when the distal end of the catheter device 1 reaches the puncture target, a force greater than the above-mentioned resistance can be applied to push the guide tube 11 distally relative to the flexible sleeve 12, so that the guide tube 11 is damaged and weakened. Part 121 protrudes from the distal opening of the flexible sheath 12 by 2 to 3 mm, so that the distal inclined edge of the guide tube 11 can penetrate into the puncture target, so that it can always remain at the puncture target during the puncture process, so as to facilitate the puncture. Needle 2 provides the puncture guide. Then the puncture needle 2 can be passed through the catheter device 1 to puncture the puncture target. Fig. 11 is a schematic diagram of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.

In the embodiment of the present invention, after the puncture of the puncture needle 2 is completed, the guide tube 11 can be pulled back proximally relative to the flexible sheath 12, so that the distal inclined edge of the guide tube 11 can retract into the distal opening of the flexible sheath 12 3~5mm. Afterwards, the guide tube 11 and the flexible sheath 12 are taken out along the original intervention route. Since the distal inclined edge of the guide tube 11 has retracted into the distal opening of the flexible sheath 12, no damage will be caused to the passing tissue. And in the process of withdrawing the catheter instrument 1, the direction of the resistance effect of the flexible sleeve 12 is in the direction of the distal end, which will not cause the flexible sleeve 12 to move proximally relative to the guide tube 11, and will not cause the guide tube 11 to move toward the proximal end. The distal end extends beyond the distal end of the flexible sheath 12 to injure tissue passed through. Fig. 12 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.

In an embodiment of the present invention, an interventional device may be provided, and the interventional device may include the above-mentioned interventional catheter device.

The interventional catheter device of the embodiment of the present invention can not only prevent damage to the surrounding tissue it passes through, but also keep it at the intervention target point in the blood vessel or tissue during the intervention process, and build a stable and reliable guiding structure for the operator to guide Puncture or insert interventional devices. The interventional catheter device has a simple structure and process, low cost, good operability, high efficiency and safety, and can meet the operator's requirements for precise guidance during curved puncture.

To sum up, the above-mentioned embodiment has described the interventional catheter device in detail. Of course, the present invention includes but is not limited to the above-mentioned implementation, and any content that is transformed on the basis of the above-mentioned embodiment falls within the scope of protection of the present invention. Those skilled in the art can draw inferences based on the content of the foregoing embodiments.

The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosures shall fall within the protection scope of the claims.

Although the present invention has been described with reference to exemplary embodiments, it should be understood that the present invention is not limited to the specific embodiments described and shown in detail herein, and that it is possible for those skilled in the art to do so without departing from the scope defined by the claims. Personnel may make various changes to the exemplary embodiments described, all such changes falling within the scope of the present invention.

While preferred embodiments of the invention have been described, additional changes and modifications to these embodiments can be made by those skilled in the art once the basic inventive concept is appreciated. Therefore, it is intended that the appended claims be construed to cover the preferred embodiment as well as all changes and modifications which fall within the scope of the invention.

Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

An interventional catheter device, characterized in that it comprises:

guide tube;

a flexible sleeve, the flexible sleeve is sleeved on the outside of the guide tube;

The flexible sheath and the guide tube can move relatively, so that the distal end of the flexible sheath 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 sheath.
The interventional catheter device according to claim 1, wherein the distal end of the flexible sheath is provided with a constriction portion, the inner diameter of the constriction portion is smaller than the outer diameter of the guide tube, and the constriction portion having a breakable weakened portion that can be broken by moving the guide tube distally relative to the flexible sheath when the interventional catheter instrument abuts against the interventional target, so that the guide tube extends beyond the distal end of the flexible sheath.
The interventional catheter device of claim 2, wherein the weakened portion extends to the distal opening of the flexible sheath.
The interventional catheter device according to any one of claims 2-3, characterized in that, the weakened portion extends to the distal opening of the flexible sheath in a linear or helical manner along the longitudinal direction of the flexible sheath.
The interventional catheter device according to any one of claims 2-4, characterized in that the weakened portion is an intermittent score line or indentation.
The interventional catheter device according to any one of claims 2-5, characterized in that, the weakened portion is provided on an inner surface or an outer surface of the weakened portion.
The interventional catheter device according to any one of claims 2-6, characterized in that, the inner diameter of the constricted part is 0.05mm-1mm smaller than the outer diameter of the guide tube.
The interventional catheter device according to any one of claims 1-7, wherein the material of the flexible sheath includes but not limited to polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12 , block polyether amide elastomer, one or more of high-density polyethylene.
The interventional catheter device according to any one of claims 1-8, characterized in that, the material of the guide tube includes but not limited to one or more of stainless steel and nickel-titanium alloy.
The interventional catheter device according to any one of claims 1-9, characterized in that, the thickness specification of the guide tube includes but not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm ~57cm.
The interventional catheter device according to any one of claims 1-10, characterized in that, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.
The interventional catheter device according to any one of claims 1-11, characterized in that, the interventional catheter device comprises a connecting piece, and the proximal end of the guide tube is connected to the proximal end of the flexible sleeve through the connecting piece. connected, and the guide tube and the flexible sleeve can move relative to each other through the connecting piece.
The interventional catheter device according to claim 12, characterized in that, the connection method of the connecting member is a screw method, a buckle method or an adhesive method.
An interventional device, characterized in that the interventional device comprises the interventional catheter device according to any one of claims 1-13.