CN116328163B

CN116328163B - Spinous process balloon capable of avoiding spinous process wire entanglement

Info

Publication number: CN116328163B
Application number: CN202310575876.8A
Authority: CN
Inventors: 荆洪娟; 曹辉; 黄嘉平
Original assignee: Hangzhou Yike Medical Technology Co ltd
Current assignee: Hangzhou Yike Medical Technology Co ltd
Priority date: 2023-05-22
Filing date: 2023-05-22
Publication date: 2023-08-11
Anticipated expiration: 2043-05-22
Also published as: CN116328163A

Abstract

The invention discloses a spinous process balloon capable of avoiding spinous process wire entanglement, which comprises a catheter and a balloon hermetically sleeved outside the catheter, wherein a plurality of spinous process wires are arranged at the balloon, the spinous process wires are uniformly distributed along the central axis of the catheter in a ring shape, the near ends and the far ends of the spinous process wires are fixed on the catheter, the balloon is positioned in a space surrounded by the spinous process wires, the balloon is provided with a contracted state when not filled and an expanded state when filled, the outer circumference of the spinous process wires is provided with at least one ring of elastic retaining ring, the retaining ring is of a wavy closed structure with wave peaks and wave troughs alternately connected, the balloon is expanded while being twisted in the process of being converted into the expanded state by the contracted state, the retaining ring retains the spinous process wires so as to avoid twisting along with the balloon, and the phenomena of poor surgical effect or operation failure caused by entanglement among the spinous process wires can be avoided, and the bad effect of broken spinous process wires caused by excessive retaining force can be avoided.

Description

Spinous process balloon capable of avoiding spinous process wire entanglement

Technical Field

The invention relates to the technical field of medical appliances, in particular to a spinous process balloon capable of avoiding spinous process wire entanglement.

Background

Coronary calcification lesions are very tricky lesions in interventions, called the "hardest bones" or "hardest fort", and many of the existing interventional instruments such as high pressure balloons, cutting balloons, spinous process balloons and atherectomy/rotational atherectomy procedures. The spinous process balloon is used as one of interventional treatment instruments for treating coronary arteries and generally comprises a balloon and a plurality of spinous process wires attached to the surface of the balloon, the spinous process wires are uniformly arranged at intervals and are only connected with the head end and the tail end of the balloon, when the balloon is inflated, the balloon is positioned in a space surrounded by the spinous process wires, and therefore the inflated balloon can continuously collide with the side wall of the spinous process wires, so that the spinous process wires are subjected to radial expansion acting force of the balloon, and then are embedded into calcified lesions to achieve the purpose of crushing the calcified lesions.

The spinous process balloon with the structure is widely applied, for example, chinese patent CN113648520A discloses a spinous process balloon dilation catheter which comprises a balloon, an outer tube and an inner tube coaxially arranged inside the outer tube in a sliding manner, a plurality of spinous process wires are arranged at the balloon, the balloon is wrapped by the spinous process wires, a control piece is arranged between the spinous process wires and the balloon, and two ends of the spinous process wires are clamped into the control piece and slide on the control piece along the length direction of the outer tube. According to the CN113648520A, a control part is added on the basis of a conventional spinous process balloon, namely, action restriction is carried out on the spinous process wires in the balloon contraction process, so that the fact that the spinous process wires are more easily restored to original positions after the balloon is contracted can be ensured, further, the balloon is more convenient to withdraw, but the CN113648520A does not carry out action restriction on the spinous process wires in the balloon expansion process or even after the balloon is expanded, entanglement among the spinous process wires can be caused, the treatment effect of calcified lesions cannot be ensured, and even operation failure can be caused.

Disclosure of Invention

The invention aims to solve the technical problems in the prior art and provides the spinous process balloon capable of avoiding the tangling of spinous process wires so as to overcome the technical defects pointed out in the background art.

According to the invention, the spinous process balloon capable of avoiding spinous process wire entanglement comprises a catheter and a balloon which is sleeved outside the catheter in a sealing mode, wherein a plurality of spinous process wires are arranged at the balloon, the spinous process wires are evenly distributed along the central axis of the catheter in a ring shape, the proximal ends and the distal ends of the spinous process wires are fixed on the catheter, the balloon is positioned in a space surrounded by the spinous process wires, the balloon is provided with a contracted state when not filled and an expanded state when filled, at least one ring of elastic retaining rings are arranged on the outer circumference of the spinous process wires, the retaining rings are of wavy closed structures with wave peaks and wave troughs alternately connected, and in the process of converting the contracted state into the expanded state, the balloon expands while twisting, and the retaining rings retain the spinous process wires so as not to twist along with the balloon.

Further, the spinous process wire comprises a first connecting wire, an action wire and a second connecting wire, wherein the proximal end of the first connecting wire and the distal end of the second connecting wire are both fixed on the catheter, the action wire is connected between the distal end of the first connecting wire and the proximal end of the second connecting wire, and the holding ring is arranged on the action wire.

Further, the first connecting wire, the action wire and the second connecting wire are all linear, and when the balloon is in an expanded state, bends for further restraining the action wire from twisting slightly are formed between the first connecting wire and the action wire and between the second connecting wire and the action wire.

Further, the holding-down rings are arranged in more than two circles, and two adjacent circles of holding-down rings are arranged at intervals and in parallel.

Further, the holding-down ring comprises a plurality of holding-down wires, each holding-down wire is connected between two adjacent action wires, and any two adjacent holding-down wires are respectively positioned at two sides of a corresponding action wire and share connection points, so that the plurality of holding-down wires are connected end to end in sequence and form a wavy closed structure.

Further, when the balloon is in an expanded state, the traction wire is in an arc shape, and when the balloon is in a contracted state, the traction wire is in an S shape.

Further, the longitudinal sections of the holding wire and the action wire are polygonal.

Further, when the balloon is in a contracted state, the balloon is wound around the outside of the catheter and has a plurality of folds, and the containment ring is in a minimum shape and causes the spinous process wires to elongate and press the folds of the balloon together with the spinous process wires.

Further, the catheter comprises an outer catheter and an inner catheter, the proximal end of the balloon is fixedly connected with the distal end of the outer catheter, the distal end of the balloon is fixedly connected with the distal end of the inner catheter exposed out of the outer catheter, and when the balloon is in a contracted state, the balloon is wound outside the inner catheter.

Further, the saccule and the inner catheter are connected together with a guide head, a connecting sleeve is fixed on the guide head, and the distal ends of the spinous process wires are fixedly connected to the connecting sleeve.

Compared with the prior art, the invention has the advantages that the retaining rings are only added on the outer circumferences of the spinous process wires, the phenomenon that the operation effect is poor or the operation fails due to entanglement among the spinous process wires is avoided, and the retaining rings are arranged into the wavy closed structure with alternately connected wave crests and wave troughs, so that the retaining force is not excessive, the effect of breaking up calcified lesions by the spinous process wires is poor, and the invention can ensure the treatment effect of the calcified lesions under the condition of meeting the requirement of simple structure.

Drawings

The invention will be more fully understood and its attendant advantages and features will be more readily understood by reference to the following detailed description, taken in conjunction with the accompanying drawings.

Fig. 1 is a schematic perspective view of a power amplifying balloon according to an embodiment of the present invention in an inflated state.

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

Fig. 3 is a schematic cross-sectional view of fig. 2.

Fig. 4 is a schematic longitudinal cross-sectional view of the balloon of fig. 2 in a contracted state.

Fig. 5 is a schematic view of the structure of the spinous process wire and containment ring of fig. 2.

FIG. 6 is a schematic view of the containment ring of FIG. 2.

In the accompanying drawings: 1 is an outer catheter, 2 is an inner catheter, 3 is a balloon, 4 is a spinous process wire, 5 is a holding ring, 6 is a guide head, 7 is a connecting sleeve, 8 is a first connecting wire, 9 is an action wire, 10 is a second connecting wire, 11 is an elastic ring, and 12 is a pulling wire.

It should be noted that the drawings are for illustrating the invention and are not to be construed as limiting the invention. Note that the drawings representing structures may not be drawn to scale. Also, in the drawings, the same or similar elements are denoted by the same or similar reference numerals.

Detailed Description

In order that the invention may be more readily understood, a detailed description of the invention is provided below along with specific embodiments and accompanying figures.

It should be noted that the terms "proximal" and "distal" in the present invention should be understood as referring to "proximal" as viewed from the direction of the attending physician, i.e., corresponding to the "left" as referred to with reference to the drawings, and "distal" as referred to herein, as referring to the end remote from the attending physician, i.e., corresponding to the "right" as referred to with reference to the drawings.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "plurality" as used herein includes two and more.

As shown in fig. 1-6, the spinous process balloon of the present embodiment is delivered via a delivery system and released at a vascular calcification site to break up the calcification as an interventional instrument. The spinous process balloon comprises an outer catheter 1, an inner catheter 2, a balloon 3, a plurality of spinous process wires 4 and a containment ring 5. The outer catheter 1 and the inner catheter 2 are coaxially arranged from outside to inside to form a catheter, and the distal end of the inner catheter 2 is exposed out of the distal end of the outer catheter 1. The balloon 3 is sleeved outside the catheter in a sealing way, the balloon 3 is a semi-compliant balloon or a non-compliant balloon and is suitable for smashing vascular calcification lesions, the balloon 3 is in a contracted state when not inflated and an inflated state when inflated, the balloon 3 is wound outside the catheter and is provided with a plurality of folds, specifically, the proximal end of the balloon 3 is fixedly connected with the distal end of the outer catheter 1, the distal end of the balloon 3 is fixedly connected with the distal end of the inner catheter 2, the balloon 3 and the inner catheter 2 are commonly connected with a guide head 6 for guiding conveying, when the balloon 3 is in the contracted state, the balloon 3 is wound outside the inner catheter 2, a channel for inputting pressure medium into the balloon 3 is formed between the outer catheter 1 and the inner catheter 2, when the pressure medium is input into the balloon 3 through the channel, the pressure medium enables the balloon 3 to be inflated and to be inflated under the action of internal pressure, otherwise, when the balloon 3 is sucked through the channel, the balloon 3 is restored to the original state, namely the contracted state.

The spinous process wires 4 are elastic, the spinous process wires 4 are evenly distributed along the central axis of the catheter in a ring shape and correspond to the balloon 3, the proximal ends and the distal ends of the spinous process wires 4 are fixed on the catheter, and the balloon 3 is located in the space surrounded by the spinous process wires 4. Specifically, the proximal ends of the plurality of spinous process wires 4 are all fixed near the distal end of the outer catheter 1 and are not connected with the balloon 3, the distal ends of the plurality of spinous process wires 4 are all fixed near the distal end of the inner catheter 2 and are not connected with the balloon 3, the connecting sleeve 7 is fixed on the guide head 6, and the distal ends of the plurality of spinous process wires 4 are all directly and fixedly connected with the connecting sleeve 7. The plurality of spinous process wires 4 are converged and enclosed to form a space, the balloon 3 is positioned in the space enclosed by the plurality of spinous process wires 4, the plurality of spinous process wires 4 are closely sleeved outside the balloon 3 and can be contracted and expanded along with the contraction of the balloon 3, when the balloon 3 is inflated and expanded, the plurality of spinous process wires 4 are stretched under the acting force of the balloon 3 to expand and form a substantially arc shape, otherwise, when the balloon 3 is not inflated and contracted, the plurality of spinous process wires 4 are automatically shortened to contract and form a substantially straight shape after the acting force of the balloon 3 is eliminated.

The retaining rings 5 are provided on the outer circumferences of the plurality of spinous process wires 4 and have elasticity, and the retaining rings 5 are provided in at least one turn, and the retaining rings 5 in this embodiment are provided in two turns, and the retaining rings 5 in two turns are arranged in parallel at intervals. The arrangement of the retaining ring 5 makes the balloon 3 expand and twist during the process of converting the balloon 3 from the contracted state to the expanded state, the retaining ring 5 can retain the spinous wires 4 without twisting along with the balloon 3, so that the phenomenon that the surgical effect is poor or the surgical failure occurs due to entanglement among the spinous wires 4 can be avoided, but if the structural arrangement of the retaining ring 5 is unreasonable, the retaining force on the spinous wires 4 is too large, and further the breaking energy of the spinous wires 4 is weakened, therefore, the retaining ring 5 is arranged into a wavy closed structure with alternately connected peaks and troughs, the effect of breaking calcified lesions by the spinous wires 4 is not good due to the retaining force, the effective length of the retaining spinous wires 4 is increased to a certain extent, the displacement of the retaining spinous wires 4 can be focused on the breaking energy of the spinous wires 4, and the effect of breaking is improved.

When the balloon 3 is in a contracted state, the balloon 3 is wound on the outside of the inner catheter 2 and has a plurality of folds, the retaining ring 5 is in a minimum shape and stretches the spinous process wires 4, and presses the folds of the balloon 3 together with the spinous process wires 4, so that the balloon 3 has a minimum radial dimension as a whole, can reach calcified lesions through complex tortuous vessels, and has good trafficability. Specifically, the spinous process wire 4 comprises a first connecting wire 8, an acting wire 9 and a second connecting wire 10, wherein the proximal end of the first connecting wire 8 and the distal end of the second connecting wire 10 are fixed on the catheter, namely, the proximal end of the first connecting wire 8 is fixed near the distal end of the outer catheter 1 and is not connected with the balloon 3, the distal end of the second connecting wire 10 is fixed on the connecting sleeve 7 near the distal end of the inner catheter 2, the acting wire 9 is connected between the distal end of the first connecting wire 8 and the proximal end of the second connecting wire 10, so that the first connecting wire 8, the acting wire 9 and the second connecting wire 10 are sequentially connected from the proximal end to the distal end to form the spinous process wire 4, in order to realize that the spinous process wire 4 is always closely sleeved outside the balloon 3, the embodiment is provided with an elastic ring 11 near the distal end of the outer catheter 1, the elastic ring 11 has elasticity and can generate deformation compensation, the proximal end of the elastic ring 11 is fixed on the outer catheter 1, the distal end of the elastic ring 11 is a free end, the elastic ring 11 is formed into a conical ring with a small proximal end and the distal end and the elastic ring 11 is also contracted and the balloon 3 is automatically contracted and the elastic ring 11 is also contracted and expanded and the balloon is the elastic ring is the most recently and contracted. When the balloon 3 is in a contracted state, the first connecting wires 8, the acting wires 9 and the second connecting wires 10 are approximately in the same straight line, and when the balloon 3 is converted from the contracted state to the expanded state and the balloon 3 is twisted while being expanded, the first connecting wires 8 and the second connecting wires 10 are all umbrella-shaped and opened to expand, namely are not twisted, so that the acting wires 9 in the expanding process are restrained to be twisted only slightly, and further the breaking energy of the acting wires 9 is focused, and when the balloon 3 is in the expanded state, bending for further restraining the acting wires 9 to be twisted slightly is formed between the first connecting wires 8 and the acting wires 9 and between the second connecting wires 10 and the acting wires 9, so that the torsion resistance of the acting wires 9 in the expanding process can be further improved, and the focusing of the breaking energy of the acting wires 9 is better realized. The holding-down ring 5 is arranged on the acting wires 9, the holding-down ring comprises a plurality of holding-down wires 12, each holding-down wire 12 is connected between two adjacent acting wires 9, and any two adjacent holding-down wires 12 are respectively positioned at two sides of a corresponding acting wire 9 and share connecting points, so that the plurality of holding-down wires 12 are sequentially connected end to form a wavy closed structure, the first connecting wire 8, the second connecting wire 10 and the holding-down wires 12 all play a role of holding-down wires 9, the first connecting wire 8 and the second connecting wire 10 hold-down wires 9 twist, the holding-down wires 12 mutually tangle and the acting wires 9 twist, when the balloon 3 is in an expanded state, the holding-down wires 12 are in an S shape, so that the holding-down force is ensured to be more proper, excessive holding-down is avoided, and torsion cannot be held down. The pulling wire 12 and the action wire 9 substantially constitute a portion in direct contact with the calcified lesion, and thus, in order to enhance the effect of treatment of the calcified lesion, the longitudinal sections of the pulling wire 12 and the action wire 9 of the present embodiment are polygonal, for example, triangular, trapezoidal, diamond-shaped, or the like.

It will be appreciated that although the invention has been described above in terms of preferred embodiments, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. The utility model provides a can avoid spinous process silk tangle's sacculus, including pipe and sealed cover establish sacculus (3) in the pipe outside, the pipe is equipped with a plurality of spinous process silk (4) in sacculus (3) department, a plurality of spinous process silk (4) are along the central axis annular evenly distributed of pipe, and the proximal end of a plurality of spinous process silk (4) is all fixed on the pipe, sacculus (3) are located the space that a plurality of spinous process silk (4) surround, sacculus (3) have the shrink state when not filling and the expansion state when filling, characterized in that, be equipped with at least one ring of having elastic restriction ring (5) on the outer circumference of a plurality of spinous process silk (4), restriction ring (5) are wave form closed structure that crest and trough are connected in turn, in the process that balloon (3) are changed to the expansion state by the contraction state, restriction ring (5) are twisted while restricting a plurality of spinous process silk (4) and make it not twist with balloon (3), the restriction ring (4) have the shrink state when filling, the shrink state and expansion state when filling, the expansion state when including two restriction silk (12) are connected in turn, two arbitrary (12) are connected in order, including that two sides (12) are connected in proper order, and each side (12) are connected in succession, and each side (12) have the restriction effect, and are connected in succession, and two restriction silk (12) and are connected to each other and have the restriction effect and are formed, when the balloon (3) is in an expanded state, the holding wire (12) is in an arc shape, and when the balloon (3) is in a contracted state, the holding wire (12) is in an S shape.

2. The spinous process balloon according to claim 1, characterized in that the proximal end of the first connecting wire (8) and the distal end of the second connecting wire (10) are both fixed on the catheter, the acting wire (9) is connected between the distal end of the first connecting wire (8) and the proximal end of the second connecting wire (10), and the retaining ring (5) is provided on the acting wire (9).

3. The spinous process balloon according to claim 2, characterized in that the first connecting wire (8), the acting wire (9) and the second connecting wire (10) are all linear, and when the balloon (3) is in an inflated state, bends for further restraining the small torsion of the acting wire (9) are formed between the first connecting wire (8) and the acting wire (9) and between the second connecting wire (10) and the acting wire (9).

4. The spinous process balloon of claim 2 wherein the containment rings (5) are provided in more than two turns, with two adjacent turns of containment rings (5) being spaced apart and arranged in parallel.

5. The spinous process balloon according to claim 1, characterized in that the longitudinal sections of both the holding wire (12) and the action wire (9) are polygonal.

6. The spinous process balloon according to claim 1, characterized in that, when the balloon (3) is in a contracted state, the balloon (3) is wound around the outside of the catheter and has a plurality of folds, the containment ring (5) is in a minimum shape and causes the spinous process wire (4) to elongate and to press the folds of the balloon (3) together with the spinous process wire (4).

7. The spinous process balloon according to claim 6, wherein the catheter comprises an outer catheter (1) and an inner catheter (2), the proximal end of the balloon (3) is fixedly connected to the distal end of the outer catheter (1), the distal end of the balloon (3) is fixedly connected to the distal end of the inner catheter (2) exposed to the outer catheter (1), and the balloon (3) is wound around the outside of the inner catheter (2) when the balloon (3) is in a contracted state.

8. The spinous process balloon according to claim 7, characterized in that the balloon (3) and the inner catheter (2) are connected together with a guide head (6), a connecting sleeve (7) is fixed on the guide head (6), and the distal ends of the spinous process wires (4) are fixedly connected to the connecting sleeve (7).