CN220360450U - Dilator and puncture assembly thereof - Google Patents
Dilator and puncture assembly thereof Download PDFInfo
- Publication number
- CN220360450U CN220360450U CN202321660767.8U CN202321660767U CN220360450U CN 220360450 U CN220360450 U CN 220360450U CN 202321660767 U CN202321660767 U CN 202321660767U CN 220360450 U CN220360450 U CN 220360450U
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- dilator
- puncture
- distal end
- tube
- hardness
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- 238000002679 ablation Methods 0.000 claims abstract description 16
- 230000010339 dilation Effects 0.000 claims abstract description 11
- 239000004020 conductor Substances 0.000 claims description 7
- 230000000916 dilatatory effect Effects 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 6
- 229920002614 Polyether block amide Polymers 0.000 claims description 3
- 238000007674 radiofrequency ablation Methods 0.000 abstract description 4
- 230000000295 complement effect Effects 0.000 abstract description 2
- 230000004044 response Effects 0.000 abstract description 2
- 210000003157 atrial septum Anatomy 0.000 description 17
- 210000005246 left atrium Anatomy 0.000 description 10
- 230000006378 damage Effects 0.000 description 5
- 210000005245 right atrium Anatomy 0.000 description 5
- 208000027418 Wounds and injury Diseases 0.000 description 4
- 230000001746 atrial effect Effects 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 208000014674 injury Diseases 0.000 description 3
- 230000007547 defect Effects 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 210000005241 right ventricle Anatomy 0.000 description 2
- 210000002620 vena cava superior Anatomy 0.000 description 2
- 206010028851 Necrosis Diseases 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 210000003191 femoral vein Anatomy 0.000 description 1
- 210000004971 interatrial septum Anatomy 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 210000001147 pulmonary artery Anatomy 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
- 210000001631 vena cava inferior Anatomy 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
Abstract
The utility model aims to provide the dilator with small wound, simple operation and accurate positioning and the puncture assembly thereof, and the puncture of the septum is realized by adopting a mode of releasing radio frequency energy by an ablation electrode, so that compared with the traditional puncture needle puncture mode, the puncture speed is high and the wound is small; the radio frequency ablation mode eliminates the prior step of exchanging instruments in operation, can simplify the operation flow and shorten the operation time; meanwhile, an ablation electrode, a temperature sensor, a pressure sensor and a developing mark are integrated on the expander, and all the functional parts complement each other, so that the positioning is accurate and the response is timely; the hardness of the expander is designed differently according to the functions of the parts on the expander, and the expander comprises a soft middle area and a tip area with higher rigidity, so that the optimal performance of the expander tube is ensured; the steerable sheath, which is adapted to the dilation tube, includes a flexible deflectable tube section corresponding to the middle portion of the dilation tube, capable of positioning the stiff distal region of the dilator at a desired location within the tissue region.
Description
Technical Field
The utility model relates to the technical field of atrial septum puncture, in particular to an expander and a puncture assembly thereof.
Background
The human heart includes a right ventricle, a right atrium, a left ventricle, and a left atrium, the right atrium being connected to the superior and inferior vena cava, the tricuspid valve separating the right atrium from the right ventricle, the right atrium being separated from the left atrium by an atrial septum. A number of diagnostic and therapeutic techniques have been developed for interventional cardiology, where catheters can be delivered to different vessels and at different locations in the heart chamber, but access to the left atrium is most difficult. Access to the left atrium through the pulmonary artery is not possible, and retrograde access to the left atrium from the left ventricle is often difficult. Thus, the most common method used to access the left atrium is by atrial septum puncture.
The main complications of traditional atrial septum puncture and the design defects of puncture tools are as follows: the main complications of atrial septal puncture occur due to inaccurate positioning and damage to the left atrium and its adjacent anatomy during puncture. Due to inaccurate positioning, the right atrium posterior wall and the aorta may be erroneously penetrated. Meanwhile, due to the design defect of the puncture tool, the left atrial injury caused by difficult puncture of the left atrial injury is increased, namely, puncture difficulty is often caused by thicker and tougher atrial septum or blunt puncture needles during atrial septum puncture, the puncture force is often required to be increased, but after the puncture needles suddenly puncture the atrial septum, the resistance of the puncture needles suddenly disappears, but the force of pushing the needles forwards cannot be immediately disappeared or even if the force of pushing the needles is immediately stopped, the needles continue to move forwards due to inertia, and the left atrial injury can be caused.
Disclosure of Invention
An object of the present utility model is to provide a dilator which is less traumatic, simple to operate and accurate in positioning.
In order to achieve the above purpose, the technical scheme adopted by the utility model is as follows: a dilator comprises a dilating tube and a handle which are longitudinally connected, wherein the dilating tube comprises a proximal part, a middle part and a distal part which are arranged from the proximal end to the distal end, the handle is connected with the proximal end of the proximal part, the outer diameter of the distal part is gradually reduced from the proximal end to the distal end, and an ablation electrode is arranged at the position close to the outer periphery of the distal part.
The outer periphery of the distal end portion is further integrated with a temperature sensor, a pressure sensor and a developing mark, and the three are arranged near the end portion of the distal end portion.
The ablation electrode, the temperature sensor, the pressure sensor and the developing mark are flush and smooth with the outline of the outer wall of the distal end part, and are connected with an external control system through an electric conductor, and the electric conductor is provided with a through hole on the distal end part and extends to the proximal end by clinging to the inner cavity wall.
The distal portion is a rigid region, the intermediate portion is a flexible region, the rigid distal portion has a hardness greater than the hardness of the flexible intermediate portion, and the proximal portion has a hardness greater than the hardness of the flexible intermediate portion.
The hardness of the distal portion is substantially the same as the hardness of the proximal portion.
The deflection angle of the middle part which is a flexible area is 180 degrees, and the flexibility degrees of the sections of the middle part are different.
The lumens of the proximal, intermediate and distal portions are of equal diameter.
The material used for the expansion tube can be one of PE, pebax, PA, PU, and the densities of the materials of the various parts are different.
Another object of the present utility model is to provide a puncture assembly that is less invasive, simple to operate, and accurate in positioning.
In order to achieve the above purpose, the technical scheme adopted by the utility model is as follows: a puncture assembly comprising a dilator, the assembly further comprising a steerable sheath and a guidewire, a dilation tube extending through the steerable sheath lumen, a rigid distal portion of the dilation tube extending beyond the steerable sheath distal end.
The steerable sheath also includes a flexible deflectable tube segment corresponding to the intermediate portion, the flexible deflectable tube segment having a deflection angle of 180 °.
The scheme at least has the following beneficial effects:
1. the atrial septum puncture is realized by adopting the mode of releasing radio frequency energy by the ablation electrode, and compared with the traditional puncture needle puncture mode, the atrial septum puncture has the advantages of high puncture speed and small wound;
2. the radio frequency ablation mode eliminates the prior step of exchanging instruments in operation, can simplify the operation flow and shorten the operation time;
3. the ablation electrode is integrated on the expander, so that the process is easy to realize;
4. the expander is integrated with an ablation electrode, a temperature sensor, a pressure sensor and a developing mark, and all the functional parts complement each other, so that the positioning is accurate and the response is timely;
5. the expander is designed to have different hardness according to the functions of the parts on the expander, and comprises a soft middle area and a tip area with higher rigidity, so that the optimal performance of the expanding tube is ensured;
6. the steerable sheath, which is adapted to the dilation tube, includes a flexible deflectable tube section corresponding to the middle portion of the dilation tube, capable of positioning the stiff distal region of the dilator at a desired location within the tissue region.
Drawings
FIG. 1 is a schematic structural view of a dilator;
FIG. 2 is an enlarged schematic view of a portion of FIG. 1;
FIG. 3 is a schematic view of the structure of the steerable sheath;
fig. 4 is a schematic structural view of a guide wire.
Detailed Description
For ease of understanding, we first define the orientations referred to hereinafter: "proximal", "proximal" refers to the side proximal to the operator/physician and "distal" refers to the side distal to the operator/physician, i.e., the side proximal to the heart, as discussed in further detail below in connection with fig. 1-4.
As shown in fig. 1 and 2, a dilator comprises a dilating tube 20 and a handle 10 which are longitudinally connected, wherein the dilating tube 20 comprises a proximal portion 21, a middle portion 22 and a distal portion 23 which are arranged from the proximal end to the distal end, the handle 10 is connected to the proximal end of the proximal portion 21, the outer diameter of the distal portion 23 is gradually reduced from the proximal end to the distal end, and an ablation electrode 24 is arranged at the position adjacent to the end on the periphery of the distal portion 23.
When the traditional puncture needle is adopted for atrial septum puncture, the puncture difficulty is caused by thicker atrial septum, tougher atrial septum or duller puncture needle, the puncture force is often required to be increased, but after the puncture needle suddenly breaks the atrial septum, the resistance of the puncture needle suddenly disappears, but the force of pushing the needle forwards cannot be immediately disappeared or even if the force of pushing the needle is immediately stopped, the needle continues to move forwards due to inertia, and the left atrium can be damaged. According to the utility model, the ablation electrode 24 is arranged at the position, close to the end, of the periphery of the distal end part 23 of the dilator, and only a small force is applied to the head of the dilator to prop against the fossa ovalis, the ablation electrode 24 releases radio frequency current, so that fossa ovalis tissues can be timely and rapidly ablated, the atrial septum puncture is completed, the left atrium is never damaged, the step of exchanging instruments in the past operation is eliminated in a radio frequency ablation mode, the operation flow is simplified, and the operation time is shortened. While integrating the ablation electrode 24 on the dilator is technically easy to implement.
As a preferable aspect of the present utility model, the outer periphery of the distal end portion 23 is also integrated with a temperature sensor 25, a pressure sensor 26, and a developing mark 27, and the three are arranged adjacent to the end portion position of the distal end portion 23. The radio frequency ablation realizes the puncture purpose by releasing radio frequency current to cause local endocardial and sub-endocardial myocardial coagulation necrosis, and the higher the released energy is, the higher the temperature is, so the temperature sensor 25 is integrated on the dilator to monitor the radio frequency energy; when the head of the expander is propped against the oval fossa, the pressure received by the head is high, and when the atrial septum puncture is completed, the pressure suddenly becomes small, so that the sudden change of the head of the expander is detected by the pressure sensor 25, and whether the atrial septum puncture is completed or not can be judged; the developing indicia 27, in conjunction with the X-ray device, can display the position of the dilator in real time. The temperature sensor 25, the pressure sensor 26 and the developing mark 27 are matched with the ablation electrode 24, so that the accuracy and the reliability of puncture are ensured.
To reduce damage to the heart, ablation electrode 24, temperature sensor 25, pressure sensor 26, and visualization mark 27 are flush with the outer wall profile of distal portion 23 and are connected to an extracorporeal control system by electrical conductors 28, with electrical conductors 28 extending proximally from distal portion 23 through holes and against the lumen wall. The routing of electrical conductors 28 includes, but is not limited to, the one described above.
The distal portion 23 is a rigid region and the intermediate portion 22 is a flexible region, the rigid distal portion 23 having a hardness greater than the hardness of the flexible intermediate portion 22 to enable advancement of the dilator through tissue to prevent deformation of the substantially rigid distal region during dilation of the puncture site. The hardness of the proximal portion 21 is greater than the hardness of the flexible intermediate portion 22, ensuring that the dilator does not substantially buckle or deform as it is advanced through the steerable sheath 30.
Preferably, the hardness of distal portion 23 is substantially the same as the hardness of proximal portion 21.
The deflection angle of the intermediate portion 22 for the flexible region is 180 deg., and the degree of flexibility of the respective sections of the intermediate portion 22 is different.
Further, the lumen diameters of the proximal portion 21, the intermediate portion 22 and the distal portion 23 are equal.
The material used for the expansion pipe 20 can be one of PE, pebax, PA, PU, and the material densities of the parts are different, so that the parts have different hardness and meet the performance requirements.
Referring to fig. 1-4, a puncture assembly comprising a dilator, the assembly further comprising a steerable sheath 30 and a guidewire 40, a dilation tube 20 extending through the lumen of the steerable sheath 30, a rigid distal portion 23 of the dilation tube 20 extending beyond the distal end of the steerable sheath 30.
The steerable sheath 30 also includes a flexible deflectable tube segment 31 corresponding to the intermediate portion 22, the flexible deflectable tube segment 31 having a deflection angle of 180 ° to minimize resistance of the dilator to deflection of the flexible deflectable tube segment 31 of the steerable sheath 30 to allow deflection of the deflectable region of the steerable sheath 30 to a desired deflection angle to position the dilator stiff distal region at a desired location within the tissue region, such that the dilator stiff distal region facilitates advancement of the dilator through the location.
When the puncture assembly of the present utility model is applied to the interatrial septum puncture, the method of use thereof is as follows: firstly, through the puncture of the right femoral vein, the steerable sheath 30 and the dilator are sent to the superior vena cava through the guide wire 40, the guide wire 40 is withdrawn, the head of the distal end part 23 of the dilator is slid downwards along the interval to the fossa ovalis direction, the head of the distal end part 23 slides into the fossa ovalis when 3 left swings or jumps occur, the ablation electrode 24 of the dilator acts to ablate tissues at the fossa ovalis, and when the pressure of the pressure sensor 25 is instantaneously reduced, the completion of the atrial septum puncture is indicated. The steerable sheath 30 and dilator are then delivered to the left atrium, the guidewire 30 and dilator are then withdrawn, and finally the heart assist device is delivered from the steerable sheath 30.
It will be understood by those skilled in the art that the present utility model is not limited to the details of the foregoing exemplary embodiments, but includes other specific forms of the same or similar structures that may be embodied without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the utility model being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.
Claims (10)
1. A dilator comprising a dilating tube (20) and a handle (10) connected longitudinally, the dilating tube (20) comprising a proximal portion (21), an intermediate portion (22) and a distal portion (23) arranged distally from a proximal end, the handle (10) being connected proximally to the proximal portion (21), the outer diameter of the distal portion (23) tapering from proximal to distal end, characterized in that: an ablation electrode (24) is provided at a position adjacent to the outer periphery of the distal end portion (23).
2. The dilator of claim 1, wherein: the periphery of the distal end portion (23) is also integrated with a temperature sensor (25), a pressure sensor (26) and a developing mark (27), and the three are arranged adjacent to the end portion position of the distal end portion (23).
3. The dilator of claim 2, wherein: the ablation electrode (24), the temperature sensor (25), the pressure sensor (26) and the developing mark (27) are flush and smooth with the outline of the outer wall of the distal end part (23), and are connected with an external control system through an electric conductor (28), and the electric conductor (28) is provided with a through hole on the distal end part (23) and is closely attached to the inner cavity wall to extend towards the proximal end.
4. The dilator of claim 1, wherein: the distal end portion (23) is a rigid region, the intermediate portion (22) is a flexible region, the hardness of the rigid distal end portion (23) is greater than the hardness of the flexible intermediate portion (22), and the hardness of the proximal end portion (21) is greater than the hardness of the flexible intermediate portion (22).
5. The dilator of claim 4, wherein: the hardness of the distal end portion (23) is substantially the same as the hardness of the proximal end portion (21).
6. The dilator of claim 4, wherein: the deflection angle of the middle part (22) which is a flexible area is 180 degrees, and the flexibility degree of each section of the middle part (22) is different.
7. The dilator of claim 1, wherein: the diameters of the inner cavities of the proximal part (21), the middle part (22) and the distal part (23) are equal.
8. The dilator of claim 1, wherein: the material used for the expansion tube (20) can be one of PE, pebax, PA, PU, and the densities of the materials of the various parts are different.
9. A puncture assembly comprising the dilator of any one of claims 1-8, characterized in that: the assembly further includes a steerable sheath (30) and a guidewire (40), the dilation tube (20) extending through the steerable sheath (30) lumen, the rigid distal portion (23) of the dilation tube (20) extending beyond the steerable sheath (30) distal end.
10. The puncture assembly of claim 9, wherein: the steerable sheath (30) also includes a flexible deflectable tube section (31) corresponding to the intermediate portion (22), the flexible deflectable tube section (31) having a deflection angle of 180 °.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202321660767.8U CN220360450U (en) | 2023-06-28 | 2023-06-28 | Dilator and puncture assembly thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202321660767.8U CN220360450U (en) | 2023-06-28 | 2023-06-28 | Dilator and puncture assembly thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN220360450U true CN220360450U (en) | 2024-01-19 |
Family
ID=89516567
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202321660767.8U Active CN220360450U (en) | 2023-06-28 | 2023-06-28 | Dilator and puncture assembly thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN220360450U (en) |
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2023
- 2023-06-28 CN CN202321660767.8U patent/CN220360450U/en active Active
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