Interventional catheter instrumentTechnical Field
The invention relates to the technical field of medical instruments, in particular to an interventional catheter instrument.
Background
The following description of the related background art of the present invention does not necessarily constitute prior art to the present invention.
Interventional radiology (Interventional Radiology) is an marginal discipline that developed rapidly in the late seventies of the twentieth century. The diagnosis and treatment method is a series of techniques for diagnosing and treating various diseases by using devices such as catheters, guide wires and the like under the guidance of medical imaging equipment based on image diagnosis and clinical diagnosis and combined with the clinical therapeutic principle. Under the guidance of imaging medicine (X-ray, ultrasonic, CT and MRI), a special catheter or instrument is inserted into the pathological part through percutaneous puncture or through the original duct of human body to perform diagnosis, contrast and treatment, or tissue acquisition to perform cytological bacteriological and biochemical examination.
Interventional radiology provides a new administration route and operation method 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 method, simpler and more convenient minimally invasive method. The interventional radiology exploits a new treatment path, is simple, convenient, safe, small in wound, less in complications, quick in effect taking, has minimally invasive property, strong in repeatability, accurate in positioning, high in curative effect, quick in effect taking, low in complication occurrence rate, and simple and easy to apply in connection with various technologies.
The interventional radiology can be divided into interventional diagnostics and interventional theraphy according to the purpose, vascular interventional radiology (drug infusion, embolism technology, shaping stent, filter technology and the like) and non-vascular radiology (puncture biopsy, drainage technology, foreign matter removal, cavity stent and the like), and tumor interventional radiology, non-tumor interventional radiology, neuro-interventional radiology and the like according to the clinical application range.
An interventional instrument is a device for performing an interventional procedure, e.g., a vascular stent kit, a percutaneous transluminal biopsy kit, a radio frequency ablation kit, a tumor embolization kit, etc. The interventional instrument may generally include, but is not limited to, any one or combination of a puncture-type instrument, a radio frequency-type instrument, a microwave-type instrument, a particle-type instrument, an implant-type instrument, a sheath-type instrument, a tube-type instrument, a biopsy-type instrument, and the like. The interventional instrument may include one or more interventional tools, which may be catheters, guidewires, lancets, vascular sheaths, balloons, biopsy needles, and the like.
Catheter techniques are widely used in interventional radiology. The prior catheter apparatuses are mostly used for establishing channels of interventional surgical instruments, and most of the catheter apparatuses do not have a specific position bending guiding function (Li Yanhao. Practical clinical interventional medical science graphic [ M ]. Beijing: science Press 2012.).
At present, catheter apparatuses clinically used in blood vessels and organs of a human body are required to be bent at a certain angle at a specific position after entering the human body, and interventional surgical apparatuses such as a puncture needle, a guide wire and the like are required to be guided after being bent. Such as the plastic catheter instruments and the metal catheter instruments of RUPS-100 puncture assemblies produced by COOK in the United states, which have a specific position bending guide structure to realize corresponding guide functions.
During an intervention, sometimes in order to achieve a guiding of the intervention, it is required that the distal end of the catheter instrument is abutted against the intervention target point, so that the intervention instrument passes through the catheter instrument, protrudes beyond the distal end of the catheter instrument, and performs the intervention accurately at the intervention target point.
To prevent injury to the tissue passing by the distal end of the catheter instrument during its passage through the interventional approach to the interventional target site, the exterior of the catheter may be provided with a flexible sheath that extends beyond the distal end of the catheter such that the distal end of the catheter is covered by the flexible sheath to prevent injury to surrounding tissue.
In interventional procedures, particularly those in which the interventional approach is long and tortuous, vascular or tissue intervention is performed by bending the interventional instrument through the catheter instrument at a certain angle within the vessel. When the distal end of the flexible sleeve sleeved outside the catheter is propped against the intervention target point, the flexible sleeve cannot be kept at the intervention target point in the intervention process due to the flexibility of the flexible sleeve, errors such as needle skipping failure or intervention direction fluctuation and the like often occur in the intervention process, great operation difficulty is caused for an operator, and the operator can only support or press a specific part of a human body through the external catheter by means of the operator at present, so that the operation difficulty of the operator is greatly increased, and the operation application is limited.
For example, in a jugular intrahepatic puncture procedure, it is critical that the catheter instrument be able to remain at the puncture target site on the hepatic vein wall for the success of the procedure (Li Yanhao. Practical clinical interventional diagnostics & diagrammetry [ M ]. Beijing: science Press 2012.). The current puncture assembly cannot effectively solve the problem (the state of development of the shunt technology of hepatic portal body via jugular vein in China and standardization thereof, china interventional radiology electronic journal, 2013,1 (2)).
Thus, there is a need for a catheter device that prevents injury to surrounding tissue and remains at the interventional target site during the interventional procedure, to prevent errors in the needle stick during the interventional procedure or errors in the direction of the intervention.
Disclosure of Invention
In view of the above, embodiments of the present invention provide an interventional catheter apparatus, so as to solve one or more of the problems of easy damage to surrounding tissues, difficulty in maintaining at an interventional target point, difficulty in operation, poor accuracy, etc. in the existing interventional operation, and realize an interventional operation that is easier to operate and more accurate and effective.
According to one aspect of the invention, an interventional catheter device is provided and is characterized by comprising a guide tube, a flexible sleeve sleeved outside the guide tube, and the flexible sleeve and the guide tube can move relatively, so 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 sheath is provided with a reduced portion having an inner diameter smaller than the outer diameter of the guide tube and a weakened portion susceptible to breakage, and when the interventional catheter instrument is abutted to an interventional target point, distal movement of the guide tube relative to the flexible sheath can damage the weakened portion so that the guide tube extends beyond the distal end of the flexible sheath.
Further, the weakened portion extends to a distal opening of the flexible sleeve.
Further, the weakened portion extends longitudinally, in a straight line or in a spiral manner along the flexible sleeve to the distal opening of the flexible sleeve.
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.
Further, the inner diameter of the reduced portion is smaller than the outer diameter of the guide tube by 0.05mm to 1mm.
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, high density polyethylene.
Further, the guide tube material includes, but is not limited to, one or more of stainless steel, nitinol.
Further, the thickness specification of the guide tube comprises, but is not limited to, 13G, 14G, 15G and 16G, and the length of the guide tube is 42 cm-57 cm.
Further, the inner diameter of the flexible sleeve is 0.1 mm-2 mm larger than the outer diameter of the guide tube.
Further, the interventional catheter instrument includes a connector by which the proximal end of the guide tube is connected to the proximal end of the flexible sheath and by which the guide tube and the flexible sheath can be moved relative to each other.
Further, the connecting mode of the connecting piece is a screw thread mode, a buckling mode or an adhesive mode.
According to one aspect of the present invention, there is provided an interventional instrument comprising an interventional catheter instrument as described above.
In summary, according to the interventional catheter apparatus of the invention, not only the surrounding tissues passed by the interventional catheter apparatus can be prevented from being injured, but also the interventional catheter apparatus can be kept at the interventional target point in the interventional process, so that errors on the needle jump puncture in the interventional process or errors on the interventional direction change can be prevented, the operation is easier, the operation is more accurate and effective, and the technical problems in the prior art are solved.
Drawings
The features and advantages of the present invention will become more readily appreciated from the following detailed description of the invention, taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a schematic view of an interventional catheter instrument and a puncture needle assembly according to an embodiment of the present invention;
FIG. 2 is a schematic view of a guide tube according to an embodiment of the present invention;
FIG. 3 is a schematic view of a flexible sleeve according to an embodiment of the present invention;
FIG. 4 is a schematic illustration of the assembly of a guide tube and flexible sheath according to an embodiment of the invention;
FIG. 5 is a schematic illustration of the state of a guide tube and flexible sheath of an embodiment of the present invention during an interventional approach to an interventional target;
FIG. 6 is a schematic view showing a state where the guide tube and the flexible sheath according to the embodiment of the present invention perform puncture guiding;
FIG. 7 is a schematic illustration of the state of the guide tube and flexible sheath of an embodiment of the present invention during exit through an interventional approach after performing a puncture guide;
FIG. 8 is a schematic view of a distal necked-down formed flexible sleeve according to an embodiment of the invention;
FIG. 9 is a schematic view of a necked-down portion of a flexible sleeve according to an embodiment of the invention;
FIG. 10 is a schematic illustration of the state of a guide tube and flexible sheath of an embodiment of the present invention during an interventional approach to an interventional target;
FIG. 11 is a schematic view showing a state where the guide tube and the flexible sheath according to the embodiment of the present invention perform puncture guiding;
fig. 12 is a schematic view of the catheter and flexible sheath of an embodiment of the present invention during exit through an interventional approach after performing a puncture guide.
Detailed Description
Exemplary embodiments of the present invention are described in detail below with reference to the accompanying drawings. The description of the exemplary embodiments is presented for purposes of illustration only and is in no way intended to limit the invention, its application, or uses.
The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.
As used in this disclosure, 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. As used herein, "distal" refers to a side distal from an operator, and correspondingly, "proximal" refers to a side opposite "distal", "distal".
FIG. 1 is a schematic view of an interventional catheter instrument and a puncture needle assembly according to an embodiment of the present invention. In an embodiment of the present invention, as shown in fig. 1, the catheter apparatus 1 may include a guide tube 11 and a flexible sheath 12 to provide a guiding guide for the needle 2. The catheter apparatus 1 may be linear or curved, for example, curved for transjugular intrahepatic puncture, depending on clinical requirements.
Fig. 2 is a schematic view of a guide tube according to an embodiment of the present invention. In embodiments of the present invention, the material of the guide tube 11 may be one or more of stainless steel, nitinol, etc., including but not limited to. According to clinical needs, the thickness of the guide tube 11 may include, but is not limited to, 13G, 14G, 15G, 16G, etc. (G is an abbreviation of GAUGE, a length measurement unit of diameter originating in North America), and the length may be 42cm to 57cm.
As shown in fig. 2, the distal end of the guide tube 11 may be beveled, may be used for performing a puncture, and may also be used to penetrate an interventional target site to abut 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, as desired clinically. In one embodiment of the present invention, the distal end of the guide tube 11 is a curved bevel blade, and the distal end of the guide tube can be curved 10 ° to 80 °, for example, 60 °, from 0.5cm to 12cm from the tip of the bevel blade.
Fig. 3 is a schematic view of a flexible sleeve according to 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 (PA 12), block polyether amide elastomer (Pebax), high Density Polyethylene (HDPE), and the like.
Fig. 4 is a schematic view of the assembly of a guide tube and flexible sheath of an embodiment of the present invention. In the embodiment of the invention, as shown in fig. 4, the flexible sleeve 12 may be sleeved outside the guide tube 11, and its inner diameter may be 0.1 mm-2 mm larger than the outer diameter of the guide tube 11. The guide tube 11 and the flexible sheath 12 may be relatively movable such that the distal end of the guide tube 11 may extend beyond the distal end of the flexible sheath 12, or the distal end of the flexible sheath 12 may extend beyond the distal end of the guide tube 11 (as shown in fig. 4).
In embodiments of the present invention, the proximal end of the flexible sleeve 12 may be threadably, snappingly, or adhesively coupled to the proximal end of the guide tube 11 via the connector 13, and the flexible sleeve 12 may be moved relative to the guide tube 12 via the connector 13. The proximal ends of the flexible sheath 12 and the guide tube 11 are shown as being threadably connected by a connector 13 in fig. 1 or 4.
In the puncture operation according to the embodiment of the present invention, the catheter apparatus 1 including the guide tube 11 and the flexible sheath 12 is first introduced into the body through an interventional route such as percutaneous or transorgan cavity to reach a puncture target. Fig. 5 is a schematic view of the state of the guide tube and flexible sheath of an embodiment of the present invention during the approach to an interventional target site. As shown in fig. 5, in 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 bevel edge of the guide tube 11 by 2-3 mm, so as to prevent the distal bevel edge from damaging the passing tissue.
In the puncture operation according to the embodiment of the present 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 moved relatively, so that the distal end of the guide tube 11 extends beyond the distal end of the flexible sleeve 12, and thus the distal end of the guide tube 11 can be immobilized against the puncture target point to perform puncture guidance. Fig. 6 is a schematic view showing a state where the guide tube and the flexible sheath according to the embodiment of the present invention perform puncture guiding.
In the puncture operation according to the embodiment of the present invention, when the catheter apparatus 1 is withdrawn through the interventional approach after performing the puncture guide, the guide tube 11 and the flexible sheath 12 are relatively moved so that the distal end of the flexible sheath 12 extends beyond the distal bevel edge of the guide tube 11 to prevent the distal bevel edge from damaging the passing tissue. Fig. 7 is a schematic view of the state of the guide tube and flexible sheath of an embodiment of the present invention during exit through an interventional approach after performing a puncture guide.
In interventional diagnosis and treatment, the distal end of a catheter instrument is subjected to the resistance action of passing tissues and organs in the process of reaching an interventional target point through an interventional approach, particularly in a long and tortuous interventional operation, and due to the flexibility of a flexible sleeve, the flexible sleeve is often caused to move proximally relative to a guide tube, so that the distal end of the guide tube extends beyond the distal end of the flexible sleeve, and surrounding tissues passing through are injured.
To solve the technical problem, in the embodiment of the present invention, the distal end of the flexible sleeve 12 may be subjected to a necking forming process to form a necking portion 121, the necking portion 121 may be tapered, and the inner diameter of the necking portion after forming may be 0.05 mm-1 mm smaller than the outer diameter of the guide tube 11. Fig. 8 is a schematic view of a distal necked-down formed flexible sleeve according to an embodiment of the invention.
Since the inner diameter of the distal end of the flexible sheath 12 formed by the reduced portion is smaller than the outer diameter of the distal end of the guide tube 11, the flexible sheath 12 will not move proximally relative to the guide tube 11 even if subjected to the resistance of the passing tissue or organ during the insertion of the catheter apparatus 1 to the insertion target site, so that the guide tube 11 will not protrude from the distal end of the flexible sheath 12, thereby injuring the passing tissue.
Further, fig. 9 is a schematic view of the necked-down portion of the flexible sleeve of 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 that 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 in a straight or spiral fashion along the longitudinal direction of the flexible sleeve 12 to its distal opening. The weakened portion 1211 may be provided on the inner surface or the outer surface of the reduced portion 121. When the weakened portion 1211 is provided on the outer surface of the reduced portion 121, a depression may be formed on the outer surface, which may cause irritation to the vessel wall and also affect the blood flow, thereby increasing the possibility of thrombus formation. Thus, the weakened portion 1211 is preferably provided to the inner surface of the reduced mouth portion 121.
The weakened portion 1211 is such that when the catheter apparatus 1 is urged distally relative to the flexible sheath 12 by a force greater than the resistance described above when the catheter apparatus 1 is abutted against the insertion target, the catheter 11 may break the weakened portion 121 and extend out of the distal opening of the flexible sheath 12. In one embodiment of the invention, the weakened portion 121 is a longitudinal indentation 1mm wide.
Thus, in the puncture operation according to the embodiment of the present invention, the guide tube 11 and the flexible sheath 12 are introduced into the body to reach the puncture target site through percutaneous or organ cavity and other interventional routes. Fig. 10 is a schematic view of a state of a guide tube and a flexible sleeve in the process of reaching an interventional target point through an interventional approach according to an embodiment of the present invention, and as shown in fig. 10, in the process, the flexible sleeve 12 is sleeved outside the guide tube 11, and a reduced mouth portion of the flexible sleeve 12 extends 2-3 mm beyond a distal oblique edge of the guide tube 11, so as to prevent the distal oblique edge from injuring passing tissues.
In the puncture operation of the embodiment of the invention, after the distal end of the catheter apparatus 1 reaches the puncture target point, an acting force larger than the resistance 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 portion 121 and extends out of the distal end opening of the flexible sleeve 12 by 2-3 mm, and thus, the distal inclined blade of the guide tube 11 can puncture the puncture target point, so that the distal inclined blade of the guide tube 11 can be always kept at the puncture target point in the puncture process, and puncture guiding guide can be provided for the puncture needle 2. The puncture needle 2 can then be passed through the catheter instrument 1 to puncture the puncture target site. Fig. 11 is a schematic view showing a state where the guide tube and the flexible sheath according to the embodiment of the present invention perform puncture guiding.
In the embodiment of the invention, after the puncture of the puncture needle 2 is completed, the guide tube 11 can be pulled back towards the proximal end relative to the flexible sleeve 12, so that the distal inclined edge of the guide tube 11 is retracted into the distal opening of the flexible sleeve 12 for 3-5 mm. Thereafter, the guide tube 11 and the flexible sheath 12 are withdrawn 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 damage is created to the tissue being passed. And during withdrawal of the catheter apparatus 1, the direction of the resistive force applied by the flexible sheath 12 is in the distal direction, which does not cause the flexible sheath 12 to move proximally relative to the guide tube 11, i.e. does not cause damage to the tissue passing by the distal end of the guide tube 11 extending beyond the distal end of the flexible sheath 12. Fig. 12 is a schematic view of the catheter and flexible sheath of an embodiment of the present invention during exit through an interventional approach after performing a puncture guide.
An interventional instrument is a device for performing an interventional procedure, e.g., a vascular stent kit, a percutaneous transluminal biopsy kit, a radio frequency ablation kit, a tumor embolization kit, etc. The interventional instrument may generally include, but is not limited to, any one or combination of a puncture-type instrument, a radio frequency-type instrument, a microwave-type instrument, a particle-type instrument, an implant-type instrument, a sheath-type instrument, a tube-type instrument, a biopsy-type instrument, and the like. The interventional instrument may include one or more interventional tools, which may be catheters, guidewires, lancets, vascular sheaths, balloons, biopsy needles, and the like.
In embodiments of the present invention, an interventional instrument may be provided, which may include an interventional catheter instrument as described above.
The interventional catheter instrument provided by the embodiment of the invention can prevent surrounding tissues from being damaged, can be kept at an interventional target point in a blood vessel or in the tissues in an interventional process, and is used for constructing a stable and reliable guide structure for an operator so as to guide puncture or implantation of the interventional instrument. 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 operators on accurate guiding during bending puncture.
In summary, the above embodiments describe the interventional catheter apparatus in detail, but the present invention is not limited to the above embodiments, and any modifications based on the above embodiments fall within the scope of the present invention. One skilled in the art can recognize that the above embodiments are illustrative.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall 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 specific embodiments described and illustrated herein, and that various changes to the exemplary embodiments may be made by those skilled in the art without departing from the scope of the invention as defined in the appended claims, and all such changes fall within the true 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. It is therefore intended that the following claims be interpreted as including the 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 modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.