CN115120843A

CN115120843A - Multi-segment controlled bend catheter with asymmetric bend profile

Info

Publication number: CN115120843A
Application number: CN202210947219.7A
Authority: CN
Inventors: 曹刚毅
Original assignee: Huanxin Medical Technology Suzhou Co ltd
Current assignee: Huanxin Medical Technology Suzhou Co ltd
Priority date: 2022-08-09
Filing date: 2022-08-09
Publication date: 2022-09-30

Abstract

The invention discloses a multi-section controllable bent catheter with an asymmetric bent shape, which realizes multi-section bending control of a micro-catheter for minimally invasive or interventional use by arranging a plurality of bent sections with obviously enhanced flexibility on the far end of a high-performance catheter, effectively enlarges the range of controllable bent angles, can adjust the range of traction force for enabling each bent section to bend and fully bend, realizes the control of the bending sequence of each bent section, applies all hypotubes with different axial total lengths of hollow patterns on two sides as metal reinforced layers of the bent sections to obtain the asymmetric bent sections, ensures that the controllable bent catheter has different maximum bent angles in two-way bending at the asymmetric bent sections, forms the expected asymmetric bent shape, has precise integral structure and smooth transmission, can precisely customize the bent shape, has various bending adjusting modes, and can adapt to the use requirements of more complicated human body lumen interventional or minimally invasive treatment, the application range of the controllable bent catheter is expanded.

Description

Multi-segment controlled bend catheter with asymmetric bend profile

Technical Field

The invention relates to the technical field of medical instruments, in particular to a multi-section controllable bending catheter with an asymmetric bending shape.

Background

The catheter is an indispensable auxiliary tool in human body lumen intervention or minimally invasive treatment operations which have bifurcated vessels and need accurate positioning, such as human body septum puncture, cardiovascular intervention, peripheral vessel intervention, heart atrial septal puncture, renal artery ablation, heart valve repair, tumor intervention embolization and the like, and generally needs to use a pre-plastic catheter to pre-establish a channel from the outside of a body to a target position so as to provide a channel for subsequent guide wires or other instruments to enter diagnosis and treatment. However, due to the difference in the personalized structure of the human body, the pre-plastic catheter cannot be completely adapted to all clinical requirements, and once the inserted catheter does not conform to the physiological structure of the patient, the catheter needs to be withdrawn and reinserted again, thereby increasing the operation time and possibly causing injury to the patient.

In order to adapt to individual differences of human physiological anatomical structures, the controllable bent catheter is produced and widely applied. The controllable bending catheter is characterized in that a controllable bending section is arranged at the far end of a catheter body of the catheter, a handle of the controllable bending catheter is used for driving a traction wire connected with the controllable bending section to move axially, so that the far end of the catheter body is bent into different angles, when the bending angle of the controllable bending section accords with the specific physiological structural characteristics of a human lumen, the handle is stopped being operated, the far end of the catheter body is aligned to the inlet of a target lumen, and then diagnosis and/or treatment instruments are conveyed into the target lumen through the catheter body.

In the prior art, the distal end of a controllable bending catheter is usually only provided with one bending section, the distal part of a single bending section can be bent in one direction, two directions, three directions or four directions, the maximum bending angles of all directions are consistent, the maximum bending angle of the single bending section is limited, if a plurality of bending sections exist, the range of the controllable bending angle can be effectively enlarged, and a plurality of human body lumens with complex shapes and circuitous changes require the distal end of the catheter to change the bending direction and shape in real time, even have multi-section bending shapes.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides the multi-section controllable bent catheter with the asymmetric bent shape, which can adapt to the use requirements of more complicated and circuitous human body lumen interventions or minimally invasive treatments and expand the application range of the controllable bent catheter.

In order to achieve the purpose, the technical scheme adopted by the invention for solving the technical problems is as follows: a multi-section controllable bent catheter with an asymmetric bent shape comprises a high-performance catheter and a control handle, wherein the far end of the high-performance catheter has certain flexibility, the near end of the high-performance catheter is connected with the fixed control handle, the wall thickness of the high-performance catheter is sequentially divided into a polymer inner layer, a metal reinforcing layer and a polymer outer layer from inside to outside, a pair of wire drawing cavities are arranged between the polymer inner layer and the metal reinforcing layer, the pair of wire drawing cavities are symmetrically arranged and penetrate through the high-performance catheter along the axial direction, a traction wire is arranged in each wire drawing cavity, a retraction mechanism is arranged in the control handle, one end of each traction wire is fixed at the far end of each wire drawing cavity, the other end of each traction wire is connected with the retraction mechanism, at least two bent sections with obviously enhanced flexibility are arranged at the far end of the high-performance catheter, at least one bent section is an asymmetric bent section, the metal reinforcing layer on the control handle is a hypotube, and regularly distributed hollow patterns are processed on the surface of the hypotube through cutting, all the hollowed-out patterns on two sides of the pair of wire drawing cavities have different axial total lengths.

Preferably, the metal reinforcing layer on the far end of the high-performance catheter is formed by a whole section of metal pipe.

Preferably, all the hollowed-out patterns on the same side of the fiber drawing cavity on the hypotube have the same shape and size and are arranged at equal intervals along the axial direction of the tube body.

Preferably, the hollow pattern is a closed figure.

Preferably, the hollowed-out patterns circumferentially enclose an angle not less than 120 degrees.

Preferably, the dragline silk cavity is located at the circumferential midpoint of the hollowed-out pattern.

Preferably, the hollow pattern is a spiral open pattern.

Preferably, the retraction mechanism includes, but is not limited to, a screw, a pulley, and a slider.

Preferably, a hand adjusting device is arranged on the control handle, the hand adjusting device is connected with and drives the folding and unfolding mechanism, and the hand adjusting device comprises, but is not limited to, a rotating wheel and a push button.

Due to the application of the technical scheme, compared with the prior art, the invention has the following beneficial effects:

the multi-section bending control of the micro-catheter for minimally invasive or interventional use is realized by arranging a plurality of bending sections with obviously enhanced flexibility on the far end of the high-performance catheter, the controllable bending angle range is effectively enlarged, the traction force range of each bending section for bending and fully bending each bending section can be adjusted, the control of the bending sequence of each bending section is realized, the sea wave tube with all hollowed-out patterns on two sides with inconsistent axial total lengths is used as a metal reinforcing layer of the bending section to obtain the asymmetric bending section, so that the controllable bending catheter is bent in two directions at the asymmetric bending section with inconsistent maximum bending angles to form an expected asymmetric bending shape, the whole structure is precise, the transmission is smooth, the bending shape can be precisely customized, the bending adjusting modes are also diversified, the use requirements of more complicated circuitous human body lumen intervention or minimally invasive treatment can be met, and the application range of the controllable bending catheter is expanded.

Drawings

FIG. 1 is a schematic structural view of an embodiment of a multi-segment steerable catheter having an asymmetric curve shape according to the present invention.

FIG. 2 is a schematic view of a high performance catheter in accordance with an embodiment of the present invention having a multi-segment steerable curved catheter with an asymmetric curve.

FIG. 3 is a schematic structural view of a high performance catheter distal metal reinforcement layer in an embodiment of a multi-segment steerable curve catheter with an asymmetric curve shape according to the present invention.

FIG. 4 is a schematic diagram of the bi-directional bending of the hypotube at the asymmetric bending section according to an embodiment of the multi-section steerable curved catheter with the asymmetric bending shape of the present invention.

FIG. 5 is a schematic view of a high performance catheter distal tip separately and simultaneously curved at a pair of asymmetric curved segments according to an embodiment of the present invention for a multi-segment steerable curved catheter with an asymmetric curved shape.

Fig. 6 is a schematic structural diagram of a hypotube at an asymmetrically curved section in various other embodiments of the multi-section steerable curved catheter having an asymmetrically curved shape according to the present invention.

FIG. 7 is a schematic view of a bend-controlling structure in one embodiment and in other various embodiments of a multi-segment bend-controlling catheter having an asymmetric curved shape, in accordance with the present invention.

In the figure: 1. a high performance conduit; 2. a control handle; 3. an inner polymer layer; 4. a metal reinforcing layer; 5. an outer polymer layer; 6. a wire drawing cavity; 7. drawing wires; 8. a retraction mechanism; 9. a curved section; 10. a hypotube; 11. hollowing out the pattern; 12. a manual adjusting device; 13. a positioning ring.

Detailed Description

The present invention will be further described in detail with reference to the following specific examples:

fig. 1 to 3 disclose an embodiment of a multi-section controllable curved catheter with an asymmetric curved shape, which comprises a high-performance catheter 1 and a control handle 2, wherein the distal end of the high-performance catheter 1 has a certain flexibility, the proximal end is connected with the fixed control handle 2, the wall thickness is divided into a polymer inner layer 3, a metal reinforcing layer 4 and a polymer outer layer 5 from inside to outside in sequence, a pair of wire drawing cavities 6 are arranged between the polymer inner layer 3 and the metal reinforcing layer 4, the pair of wire drawing cavities 6 are symmetrically arranged and penetrate through the high-performance catheter 1 along the axial direction, a traction wire 7 is arranged in each cavity, a retraction mechanism 8 is arranged in the control handle 2, one end of the traction wire 7 is fixed at the distal end of each wire drawing cavity 6, the other end of the traction wire is connected with the retraction mechanism 8, two curved sections 9 with significantly enhanced flexibility are arranged at the distal end of the high-performance catheter 1, both the curved sections 9 are asymmetric curved sections 9, and the metal reinforcing layer 4 is an integral hypotube 10, the surface is cut to form regularly distributed hollow patterns 11, and all the hollow patterns 11 on two sides of the pair of wire drawing cavities 6 at the asymmetric bending section 9 have different axial total lengths.

In the above embodiments and other embodiments of the invention:

the metal reinforcing layer 4 is preferably made of a whole section of metal tubing, the metal tubing is usually made of stainless steel or nickel-titanium alloy or cobalt-chromium alloy, a part of the upper portion of the section of metal tubing is cut and processed into a conventional hypotube 10 with regular and uniform hollow patterns 11 to form a symmetrical bending section 9, a part of the upper portion of the section of metal tubing is cut and processed into a hypotube 10 with all hollow patterns 11 on both sides having different axial total lengths to form an asymmetrical bending section 9, and the other portion of the section of metal tubing is cut and processed into a helical tube shape or a braided tube shape or a hypotube shape with a flexibility significantly weaker than that of the symmetrical bending section 9 and the asymmetrical bending section 9, by taking the above embodiment as an example, with reference to fig. 4 and 5, the far end of the high-performance catheter 1 is bent from the bending section 9 toward one side of the traction wire 7 to the inner side of the hollow patterns 11 to be sufficiently flattened and the tube walls are mutually abutted, so as to define a maximum bending angle, the accurate control of the maximum bending angle at each bending section 9 is realized, the difference lies in that the two-way maximum bending angles of the symmetrical bending sections 9 are consistent, the two-way maximum bending angles of the hypotubes 10 at the asymmetrical bending sections 9 are inconsistent, 5A indicates that the far end of the high-performance catheter 1 is bent at the pair of asymmetrical bending sections 9 in two ways and independently, 5B indicates that the far end of the high-performance catheter 1 is bent at the pair of asymmetrical bending sections 9 in two ways and simultaneously, the flexibility of each bending section 9 can be differentiated in the design and production process of the multi-section controllable bending catheter, the range of the traction force for bending and fully bending each bending section 9 is adjusted, the control of the bending sequence of each bending section 9 is realized, and the quantity, distribution and the two-way maximum bending angles of the symmetrical bending sections 9 and the asymmetrical bending sections 9 are not limited and are adjusted according to the use requirements of the actual operation;

with reference to fig. 4 and 6, in the above embodiments, 6A, 6B and 6C, all the hollow patterns 11 on the same side where the wire drawing cavity 6 is located on the hypotube 10 at the asymmetric bending section 9 are consistent in shape and size and are arranged at equal intervals along the axial direction of the hypotube body, in the above embodiments and 6A, all the hollow patterns 11 on both sides of the hypotube 10 at the asymmetric bending section 9 are one-to-one symmetric with respect to the central axis of the hypotube 10, in the 6B and 6C, all the hollow patterns 11 on both sides of the hypotube 10 at the asymmetric bending section 9 are arranged along the central axis of the hypotube 10 in a staggered manner, in the above embodiments, 6A, 6B and 6C, all the hollow patterns 11 on the hypotube 10 at the asymmetric bending section 9 are closed patterns, and are represented as annular rectangles, the width of the annular rectangle on one side is greater than the width of the annular rectangle on the other side, the angle preferably not less than 120 degrees surrounded by the circumferential direction of the hollow patterns 11, the wire drawing cavity 6 is located at the circumferential midpoint of the hollow patterns 11, ensuring that the circumference of the hollowed-out pattern 11 can be stressed uniformly to resist the stress of the tube body and fully flatten the hollowed-out pattern 11 when the hypotube 10 is bent, but the tube body does not generate model deformation, the hypotube 10 at the asymmetric bending section 9 in 6D is in a spiral strip shape, the hollowed-out pattern 11 is a spiral open pattern and is represented as a whole continuous spiral gap, the width of the gap at one side is larger than that of the gap at the other side through cutting processing, the hollowed-out pattern 11 at the asymmetric bending section 9 in 6E has a regularly changed circumferential angle, but the hollowed-out patterns 11 at the two sides where a pair of traction wires are located are still wide and narrow;

as shown in fig. 7A, 7B and 7C, the distal end of the high performance catheter 1 is formed into a tube mouth with a convergent shape and easy to pass through the lumen of a human body by gradually narrowing the diameter, the distal end of the wire drawing cavity 6 axially penetrating the high performance catheter 1 is stopped inside the tube mouth, a positioning ring 13 is fixed in the wall thickness of the distal end of the high performance catheter 1, the distal end of the traction wire 7 is connected and fixed with the positioning ring 13 to realize the connection, fixation and traction transmission of the distal end of the high performance catheter 1, the retraction mechanism 8 and the manual adjustment device 12 on the control handle 2 in 7A are represented as a wire wheel and a rotating wheel, the wire wheel and the rotating wheel are coaxially arranged and connected and fixed or integrated with each other perpendicular to the axial direction of the high performance catheter 1, the proximal ends of a pair of traction wires 7 are respectively connected and fixed to both sides of the wire wheel, the rotating wheel drives the wire wheel to rotate to wind one traction wire 7 and loosen the other traction wire 7, so that the lengths of the pair of traction wires 7 left in the wire drawing cavity 6 are different, therefore, the far end of a high-performance catheter 1 with certain flexibility can slightly bend towards one side of a wire drawing cavity 6 with a short length of a traction wire 7 in the cavity and obviously bend at a bending section 9 with obviously enhanced flexibility, a retracting mechanism 8 and a manual adjusting device 12 on a handle in a 7B system are represented as a pair of sliding blocks and a pair of pushing buttons, the sliding blocks and the pushing buttons are fixedly connected and arranged in groups, the near ends of the pair of traction wires 7 and the pair of sliding blocks are fixedly connected one by one, the pair of pushing buttons are moved to drive the pair of sliding blocks to leave part of the length of the pair of traction wires 7 in the wire drawing cavity 6 along the axial direction of the high-performance catheter 1 to generate difference, a retracting mechanism 8 and a manual adjusting device 12 in a 7C system are represented as a double-thread screw rod and a rotating wheel, the wire wheel and the rotating wheel are coaxially arranged and connected and fixed or integrated in parallel to the axial direction of the high-performance catheter 1, the near ends of the pair of traction wires 7 are respectively connected and fixed to the near ends of the double-thread screw rod and respectively wound in a pair of threads with opposite rotating directions, the rotating wheel is rotated to drive the double-thread screw to axially wind one traction wire 7 and unwind the other traction wire 7, and the lengths of the parts of the pair of traction wires 7 left in the wire drawing cavity 6 can also be different.

The above-mentioned embodiments are merely illustrative of the technical idea and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the scope of the present invention, and all equivalent changes or modifications made according to the spirit of the present invention should be covered in the scope of the present invention.

Claims

1. Controllable curved pipe of multistage with asymmetric bending shape, including high performance pipe (1) and brake valve lever (2), high performance pipe (1) distal end has certain compliance, and fixed brake valve lever (2) are connected to the near-end, and the wall thickness is by interior and divide into polymer inlayer (3), metal enhancement layer (4) and polymer skin (5) outward in proper order, be equipped with one between polymer inlayer (3) and metal enhancement layer (4) and to drawing wire chamber (6), it is a pair of drawing wire chamber (6) symmetry sets up, all runs through high performance pipe (1) along the axial, and the intracavity is equipped with traction wire (7), establish in brake valve lever (2) and receive and release mechanism (8), traction wire (7) one end is fixed in drawing wire chamber (6) distal end, and receive and release mechanism (8), its characterized in that are connected to the other end: the high-performance catheter is characterized in that at least two bending sections (9) with remarkably-strengthened flexibility are arranged at the far end of the high-performance catheter (1), at least one bending section (9) is an asymmetric bending section (9), the metal reinforcing layer (4) on the bending section is a hypotube (10), regularly-distributed hollow patterns (11) are processed on the surface of the hypotube (10) through cutting, and all the hollow patterns (11) on two sides of the upper pair of wire drawing cavities (6) have inconsistent axial total lengths.

2. The multi-segment steerable catheter with an asymmetric curved shape according to claim 1, characterized in that: the metal reinforcing layer (4) on the far end of the high-performance catheter (1) is composed of a whole section of metal pipe.

3. The multi-segment steerable curved catheter with an asymmetric curved shape, as in claim 1, wherein: all the hollowed-out patterns (11) on the same side where the wire drawing cavity (6) is located on the hypotube (10) are consistent in shape and size and are arranged at equal intervals along the axial direction of the hypotube body.

4. The multi-segment steerable curved catheter with an asymmetric curved shape, as in claim 1, wherein: the hollow pattern (11) is a closed figure.

5. The multi-segment steerable curved catheter with an asymmetric curved shape, as in claim 4, wherein: the hollow pattern (11) circumferentially encloses an angle not less than 120 degrees.

6. The multi-segment steerable catheter with an asymmetric curved shape according to claim 5, characterized in that: the drawing silk cavity (6) is located at the circumferential midpoint of the hollowed-out pattern (11).

7. The multi-segment steerable catheter with an asymmetric curved shape according to claim 1, characterized in that: the hollow pattern (11) is a spiral open pattern.

8. The multi-segment steerable curved catheter with an asymmetric curved shape, as in claim 1, wherein: the retraction mechanism (8) comprises but is not limited to a screw, a wire wheel and a slide block.

9. The multi-segment steerable curved catheter with an asymmetric curved shape, as in claim 8, wherein: the control handle (2) is provided with a hand adjusting device (12), the hand adjusting device (12) is connected with and drives the retraction mechanism (8), and the hand adjusting device (12) comprises a rotating wheel and a push button.