Disclosure of Invention
It is an aim of embodiments of the present disclosure to provide a shock wave multi-balloon catheter to address the problems of the prior art. In order to solve the technical problems, the embodiments of the present disclosure adopt the following technical solutions:
The embodiment of the disclosure provides a shock wave multi-balloon catheter, which comprises a first tube body, wherein a balloon part is arranged at the far end of the first tube body, the balloon part at least comprises two balloons, at least one electrode pair is arranged in each balloon, the electrode pair is used for transmitting shock waves to a specified direction, a tail seat is arranged at the near end of the first tube body, and the electrode pair is connected with a shock wave generator through the tail seat.
In some embodiments, when the number of the balloons is plural, the plural balloons are disposed at the distal end of the first tube body in order.
In some embodiments, when the number of the balloons is plural, different pairs of electrodes are provided in different ones of the balloons.
In some embodiments, the balloon portion includes a first balloon and a second balloon disposed in sequence, the first balloon disposed closer to an end of the first tube.
In some embodiments, the device further comprises a second tube disposed at an end of the first tube, the first tube having a diameter greater than a diameter of the second tube.
In some embodiments, the first balloon is disposed at a junction of the first tube and the second tube.
In some embodiments, the first balloon employs a compliant balloon and the second balloon employs a semi-compliant or non-compliant balloon.
In some embodiments, the first balloon is made of at least one of natural latex, silicone, TPU, and the second balloon is made of at least one of PET, nylon, polyethylene, polyamide, or modified polyamide.
In some embodiments, the plurality of electrode pairs includes a first electrode pair located inside the first balloon, a second electrode pair located inside the second balloon, and a third electrode pair for transmitting shock waves in a forward direction, the second electrode pair and the third electrode pair for transmitting shock waves in a radial/forward direction.
In some embodiments, the first electrode pair includes a first inner electrode, a first outer electrode, and an insulating layer, the first inner electrode is cylindrical and is embedded into an end surface of the first pipe body, and the first outer electrode is disposed on an outer surface of an end portion of the first pipe body.
In some embodiments, the first outer electrode is hollow cylindrical with a plurality of openings at the center for passage of a guidewire, and the first inner electrode is disposed through the remaining openings on the first outer electrode and aligned with the first outer electrode.
In some embodiments, the second electrode pair or the third electrode pair includes a second inner electrode, a limiting ring, and a second outer electrode, where the second inner electrode is in a shape of a circular sheet, the second outer electrode is fixed on an outer surface of the first tube body, and the second inner electrode is fixed by the second outer electrode through the limiting ring.
In some embodiments, a guidewire lumen, at least one fluid lumen, and at least one conductive wire lumen are coaxially disposed within the first tube.
In some embodiments, each of the balloons is in communication with a corresponding one of the fluid lumens, and the electrode pairs in each of the balloons are in communication with a corresponding one of the conductive wire lumens.
In some embodiments, the first tube body includes a guidewire lumen, a first fluid lumen, a second fluid lumen, a first conductive wire lumen, and a second conductive wire lumen are disposed around the guidewire lumen, the first fluid lumen is in communication with the first balloon, the second fluid lumen is in communication with the second balloon, the first conductive wire lumen is connected to the first electrode pair, and the second conductive wire lumen is connected to the second electrode pair and the third electrode pair.
In some embodiments, a through hole is provided on the first tube body at a designated position for passing a fluid therethrough, and the fluid chamber communicates with the balloon through the through hole.
In some embodiments, one end of the tailstock is connected to the first pipe body through a strain relief pipe, and the other end of the tailstock is connected to the adapter through a cable.
In some embodiments, the tailstock includes a plurality of side walls for corresponding connection with the balloon portion and the electrode pair within the balloon portion, respectively, through the fluid lumen and the conductive wire lumen in the first tube.
In some embodiments, the tailstock includes a first sidewall in communication with the first balloon through the fluid chamber, a second sidewall in communication with the second balloon through the fluid chamber, and a third sidewall connected to a plurality of the conductive wire chambers.
According to the embodiment of the disclosure, the plaque on electrode pair and the plaque breaking electrode pair can effectively break up vascular plaque located in front and at the side, so that the catheter can smoothly pass through a lesion position with higher stenosis, and the operation of an operator in the operation is greatly facilitated.
Detailed Description
Various aspects and features of the disclosure are described herein with reference to the drawings.
It should be understood that various modifications may be made to the embodiments of the application herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of this disclosure will occur to persons of ordinary skill in the art.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.
These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment, given as a non-limiting example, with reference to the accompanying drawings.
It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the present disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.
The above and other aspects, features and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings.
Specific embodiments of the present disclosure will be described hereinafter with reference to the drawings, however, it should be understood that the embodiments disclosed are merely examples of the disclosure which may be practiced in various ways. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the disclosure in unnecessary or unnecessary detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.
The disclosed embodiments provide a shock wave multi-balloon catheter, as shown in fig. 1-6, that can be used as an annuloplasty dilation catheter for filtering and capturing crushed or vulnerable aortic plaque or formed thrombus generated during annuloplasty dilation procedures, and for this purpose pertains to a medical device capable of providing immediate protection during medical procedures.
As shown in fig. 1 and 2, fig. 1 shows a schematic structural view of the shock wave multi-balloon catheter, fig. 2 shows a schematic structural view of a distal end of the shock wave multi-balloon catheter, which in this embodiment is particularly used for opening an occluded blood plug and for angioplasty, comprising a first tube body 102 and a second tube body 113, the second tube body 113 being provided at a distal end portion of the first tube body 102, that is, the first tube body 102 is closer to an operator than the second tube body 113, wherein a tube body diameter of the first tube body 102 is larger than a diameter of the second tube body 113, and wherein the tube body diameter of the first tube body 102 is set to 1.0-2.5mm.
Further, the first tube body 102 adopts a hollow multi-cavity tube structure, specifically, a guide wire cavity, at least one fluid cavity and at least one conductive wire cavity are coaxially arranged in the first tube body 102, the guide wire cavity can be arranged in the middle of the section of the first tube body 102, the fluid cavity and the conductive wire cavity are arranged around the guide wire cavity, the guide wire cavity is used for introducing and allowing a guide wire to pass through, for example, a guide wire with the size of 0.014-0.035inch can be accommodated, the fluid cavities are used for passing through fluid, the diameter of each fluid cavity can be set to be 0.2-1.0mm, the conductive wire cavity is used for accommodating a wire, and the diameter of each conductive wire cavity can be set to be 0.2-1.0mm.
Further, the distal end of the first tube 102 is provided with a balloon portion, where the balloon portion is disposed on the first tube 102 and includes at least one balloon, and when the number of the balloons is plural, plural balloons are sequentially disposed at the distal end of the first tube 102 along the length direction of the first tube 102. The number of the balloons corresponds to the number of the fluid cavities, each balloon is communicated with the corresponding fluid cavity so as to convey fluid to the balloons through the fluid cavities, and the balloons are expanded and inflated in the blood vessel after the fluid is conveyed.
Further, a through hole for fluid to pass through is provided at a designated position on the first tube 102, and the fluid cavity is communicated with the corresponding balloon through the through hole, so that the interior of the balloon is filled with fluid, and the balloon is inflated to realize expansion. The balloon herein has at least a portion of its outer surface in contact with the vessel wall and the calcified lesion after filling.
Further, at least one electrode pair is provided inside the balloon, where the electrode pair is for transmitting shock waves in a specified direction, where the shock waves can break up blocky obstructions in blood vessels, etc. In one embodiment, a plurality of low-profile electrode pairs are disposed within the balloon. Further, when the number of the balloons is plural, a different number of electrode pairs may be provided in different ones of the balloons, wherein the electrode pairs in each of the balloons communicate with the corresponding conductive wire lumen through which a lead wire for the electrode pairs is accommodated.
By applying a momentary high voltage to the electrode pair inside the balloon to generate an arc, the expansion and collapse of the bubbles generated by the arc is accompanied by the generation of a shock wave, which is conducted radially to the surface of the balloon via the fluid inside the balloon and further to calcified lesions via the surface of the balloon. When the shock wave is conducted to the calcified lesion, the compressive stress of the shock wave causes the calcified tissue inside the calcified lesion to soften, crack or break up the calcium deposit, and the shock wave of appropriate strength can be satisfied to destroy the calcified tissue without imposing an additional burden on the soft tissue surrounding the calcified tissue.
As further shown in fig. 1, a tail seat 104 is disposed at a proximal end of the first tube 102, and the tail seat 104 is connected to the proximal end of the first tube 102 through a stress relief tube 103, where the stress relief tube 103 may be used for adjusting stress, and the distal end refers to an end of the first tube 102 away from an operator, and the proximal end refers to an end of the first tube 102 close to the operator.
Further, the tailstock 104 is connected to an adapter 106 by a cable 105, where the adapter 106 is connected to a shock wave generator that passes through the adapter 106 and the wires to transfer energy to the electrode pairs.
Further, in the embodiment shown in fig. 2, the number of the balloons herein may be determined according to the requirement, for example, the number may include a first balloon 100 and a second balloon 101 that are sequentially disposed, where the first balloon 100 is disposed at an end of the first tube 102, for example, may be disposed between the first tube 102 and the second tube 113, and is partially sleeved outside the end of the first tube 102, and is partially sleeved outside the second tube 113, and the second balloon 101 is disposed on the first tube 102 and is completely sleeved outside the first tube 102.
The first balloon 100 herein preferably employs a compliant balloon that has good telescoping, inflation and insulation properties, and that does not require folding, thus significantly reducing deformation of the end of the first tube 102. The first balloon 100 may be made of soft materials such as natural latex, silica gel, TPU, etc., and the first balloon 100 made of the above materials has better adaptability.
The second balloon 101 here is a semi-compliant or non-compliant balloon, for which purpose a high pressure (e.g. 10-30 ATM) may be applied to the second balloon 101, which may be suitable for expanding a calcified vascular lesion. The second balloon 102 is made of a polymer material such as PET (polyethylene terephthalate), nylon, polyethylene, polyamide or modified polyamide (block polyamide resin).
As shown in fig. 2, in the case where the balloon includes the first balloon 100 and the second balloon 101, a plurality of pairs of electrodes may be disposed in the first balloon 100 and/or the second balloon 101, respectively, where the electrodes transmit directional shock waves toward a predetermined direction, and the pairs of electrodes are disposed at positions capable of securing an action position of the shock waves, thereby reducing damage of shock wave energy. The plurality of electrode pairs here in the present embodiment include, for example, a first electrode pair 107, a second electrode pair 108a, and a third electrode pair 108b. Wherein the first electrode pair 107 is located inside the first balloon 100, and the second electrode pair 108a and the third electrode pair 108b are located inside the second balloon 101. In another embodiment, a fourth electrode pair or more may be further disposed within the second balloon 101 along the length of the first tube 102 to facilitate the morcellation of calcified plaque along the length of the vessel by shock waves through the electrode pairs.
Since the electrodes send directional shock waves to a predetermined direction, in this embodiment, the first electrode pair 107 may be used as a plaque-opening electrode pair, which may send shock waves forward to break up plaque located in front, so that the first tube 102 and the second tube 113 may smoothly pass through a lesion position with a higher stenosis to achieve an opening function, the second electrode pair 108a and the third electrode pair 108b may be used as plaque-breaking electrode pairs, which may send shock waves radially to break up vascular plaque located in side direction, and of course, the second electrode pair 108a and the third electrode pair 108b may also send shock waves forward based on different structures.
It should be noted that, the electrode pairs can be selectively excited to transmit the shock wave through different electrode pairs, an operator can select any electrode pair to transmit the shock wave, and also can sequentially excite different electrode pairs, and can excite all electrode pairs simultaneously, so that the operation of the operator in the operation is greatly facilitated.
Accordingly, since in the present embodiment each of the first balloon 100 and the second balloon 101 is provided, and the corresponding electrode pair is provided in each of the balloons, in one embodiment the first tube 102 comprises a wire lumen 120, around which wire lumen 120 a first fluid lumen 118, a second fluid lumen 119, a first conductive wire lumen 121 and a second conductive wire lumen 122 are provided, where the first fluid lumen 118 is in communication with the first balloon 100, the second fluid lumen 119 is in communication with the second balloon 101, the first conductive wire lumen 121 is in communication with the first electrode pair 107, and the second conductive wire lumen 122 is in communication with the second electrode pair 108a and the third electrode pair 108 b.
The structures of the first electrode pair 107, the second electrode pair 108a, and the third electrode pair 108b are further described below.
Further, as shown in fig. 4 and 5, the first electrode pair 107 includes a first inner electrode 115, a first outer electrode 116, and an insulating layer, the first inner electrode 115 is embedded in an end face of the distal end of the first tube body 102, the first inner electrode 115 is cylindrical, the length of which is set to be 0.1-1.0mm, and the diameter of which is set to be 0.1-0.7mm, the first outer electrode 116 is disposed on an outer surface of an end portion of the first tube body 102, wherein the first outer electrode 116 is hollow cylindrical and has a plurality of openings, wherein the opening at a center of a circle can be used for passing a guide wire, and the first inner electrode 115 is disposed through the remaining openings on the first outer electrode 116 and aligned with the second outer electrode 116. The inner diameter of the first external electrode 116 is set to 0.5-1.5mm and the wall thickness is set to 0.03-0.2mm. In addition, the electrode materials of the first inner electrode 115 and the first outer electrode 116 may be stainless steel, tungsten, platinum iridium, nickel, iron, steel, and/or other conductive materials.
Further, the second electrode pair 108a and the third electrode pair 108b have the same structure, wherein each of the second electrode pair 108a and the third electrode pair 108b includes a second inner electrode, a stop ring, and a second outer electrode, wherein the stop ring can limit the position of the second inner electrode to ensure concentric arrangement of the second inner electrode and the second outer electrode, and the configuration of the inner and outer electrodes allows the first tube 102 to have a smaller outer diameter and has a function of transmitting shock waves in the forward and lateral directions.
Specifically, the third electrode pair 108b will be specifically described below as an example. The third electrode pair 108b includes a second inner electrode 109, a stopper ring 111, and a second outer electrode 110, where the second inner electrode 109 is in a shape of a circular plate having a diameter of 0.1-1.0mm and a thickness of 0.03-0.3mm, where the second electrode 109 is fixed to the outer surface of the first tube 102 by welding, gluing, riveting, or the like, or any other suitable means, and where the second outer electrode 110 is in a shape of a circular ring, and the second outer electrode 110b can surround the second inner electrode 109, where a space between the second outer electrode 110 and the second inner electrode 109 is 0.1-1.5mm. In addition, the materials of the second inner electrode 109 and the second outer electrode 110 may be stainless steel, tungsten, platinum iridium, nickel, iron, steel, and/or other conductive materials.
Further, fig. 6 shows a schematic structural diagram of the tail stock 104, the tail stock 104 comprises a plurality of side walls, which are used for being correspondingly connected with the balloon portion and the electrode pair in the balloon portion through the fluid cavity and the conductive wire cavity in the first tube body 101, respectively, wherein in the embodiment of fig. 6, the tail stock 104 comprises a first side wall 123, a second side wall 124 and a third side wall 125, wherein the first side wall 123 in the tail stock 104 is communicated with the first balloon 100 through the fluid cavity, for which purpose, the first side wall 123 can be connected with a push injector, fluid is injected through the push injector to control expansion and contraction of the first balloon 100, the second side wall 124 in the tail stock 104 is communicated with the second balloon 101 through the fluid cavity, for which purpose, the second side wall 124 can be connected with the push injector, fluid is injected through the push injector to control the expansion balloon, the second side wall 123 is connected with the conductive wire in the tail stock 100 through the conductive wire, the conductive wire is not connected with the conductive wire in the three-phase change-over cavity, and the conductive wire is not connected with the conductive wire cavity 106, for ensuring that the electric connection between the three-phase-change-conductive wire is not connected with the conductive wire cavity 106.
According to the embodiment of the disclosure, the plaque on electrode pair and the plaque breaking electrode pair can effectively break up vascular plaque located in front and at the side, so that the catheter can smoothly pass through a lesion position with higher stenosis, and the operation of an operator in the operation is greatly facilitated.
Moreover, although operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the present disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.
Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are example forms of implementing the claims.
While various embodiments of the present disclosure have been described in detail, the present disclosure is not limited to these specific embodiments, and various modifications and embodiments can be made by those skilled in the art on the basis of the concepts of the present disclosure, which modifications and modifications should fall within the scope of the claims of the present disclosure.