CN115737010B - Dilator for interventional therapy equipment - Google Patents
Dilator for interventional therapy equipment Download PDFInfo
- Publication number
- CN115737010B CN115737010B CN202211576730.7A CN202211576730A CN115737010B CN 115737010 B CN115737010 B CN 115737010B CN 202211576730 A CN202211576730 A CN 202211576730A CN 115737010 B CN115737010 B CN 115737010B
- Authority
- CN
- China
- Prior art keywords
- section
- pole
- rod
- dilator
- outer diameter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000002560 therapeutic procedure Methods 0.000 title claims abstract description 28
- 239000000463 material Substances 0.000 claims description 62
- 230000007704 transition Effects 0.000 claims description 13
- 230000007246 mechanism Effects 0.000 claims description 8
- 230000002439 hemostatic effect Effects 0.000 description 16
- 238000000034 method Methods 0.000 description 8
- 210000004204 blood vessel Anatomy 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 229920001903 high density polyethylene Polymers 0.000 description 6
- 239000004700 high-density polyethylene Substances 0.000 description 6
- 229920003023 plastic Polymers 0.000 description 6
- 239000004033 plastic Substances 0.000 description 6
- 229920002614 Polyether block amide Polymers 0.000 description 5
- 238000005452 bending Methods 0.000 description 5
- 230000003902 lesion Effects 0.000 description 5
- 239000004433 Thermoplastic polyurethane Substances 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 229920001971 elastomer Polymers 0.000 description 4
- 229920001684 low density polyethylene Polymers 0.000 description 4
- 239000004702 low-density polyethylene Substances 0.000 description 4
- 229920002803 thermoplastic polyurethane Polymers 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 239000004952 Polyamide Substances 0.000 description 2
- 239000004721 Polyphenylene oxide Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 2
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 2
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000000916 dilatatory effect Effects 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 230000023597 hemostasis Effects 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 206010033675 panniculitis Diseases 0.000 description 2
- 229920002647 polyamide Polymers 0.000 description 2
- 239000004417 polycarbonate Substances 0.000 description 2
- 229920000570 polyether Polymers 0.000 description 2
- 239000005060 rubber Substances 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 210000003491 skin Anatomy 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 210000004304 subcutaneous tissue Anatomy 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 229940030225 antihemorrhagics Drugs 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000002059 diagnostic imaging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000000025 haemostatic effect Effects 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
Abstract
The invention discloses a dilator for interventional therapy equipment. The dilator comprises: the dilator stem and the dilator seat. The dilator rod is a hollow rod-shaped member comprising, in order from a distal end to a proximal end, a first rod segment comprising a tip, a second rod segment and a third rod segment. The outer diameter of the second rod section of the expander rod is smaller than or equal to the outer diameter of the first rod section, and the outer diameter of the first rod section is smaller than or equal to the outer diameter of the third rod section; the hardness of the first pole section is smaller than that of the third pole section, and the hardness of the second pole section is smaller than or equal to that of the third pole section. The expander seat is arranged on the outer surface of the third rod section and comprises a buckle, and the buckle is used for fixing the expander seat and the interventional therapy equipment; the buckle is a fin mounted to the dilator seat and extends axially along the dilator shaft. The invention optimizes the flexibility and the conveying performance of the expander of the interventional treatment equipment; the safety of the equipment is improved; and the accuracy of the catheter delivery position is improved.
Description
Technical Field
The present invention relates to medical devices, and more particularly to a dilator for interventional therapy devices.
Background
The interventional therapy is a minimally invasive therapy by using modern high-tech means, and is to introduce special precise instruments such as catheters, guide wires and the like into a human body under the guidance of medical imaging equipment to diagnose and treat the in vivo pathological condition locally. The incision (puncture point) for interventional therapy is small, and diseases which cannot be treated in the past and have poor curative effects of surgery or medical treatment, such as thrombus, tumor, various bleeding and the like, can be treated without cutting human tissues.
The existing dilator is generally matched with a puncture catheter in an interventional operation, and has the functions of tracking the atraumatic skin, subcutaneous tissue and blood vessel of a guide wire to open a passage for instruments matched with the operation when the interventional operation is performed, and simultaneously, the dilator is used as a guide to convey a matched catheter in place, and the length of a catheter sheath matched with the dilator is generally shorter than that of the dilator.
A commonly used interventional procedure dilator system has the following features:
1. Materials: inexpensive and low-density plastics such as PP (polypropylene) and HDPE (high-density polyethylene), but these materials are generally high in hardness, usually 65 to 70D, and not strong in flexibility and overstretching ability;
2. size: the length is generally short, and the lesion part is not reached;
3. shape: the distal end (head end) of the dilator rod is tapered with smaller angle, so that the skin, subcutaneous tissues and blood vessels can be conveniently and relatively safely expanded, and other parts of the dilator rod except the distal end are cylinders with the same diameter;
4. The structure is as follows: in the axial direction, the center of the expander rod is provided with an opening, so as to conform to the guide of a guide wire and prevent the damage caused by the time stamp of the access to the blood vessel; the proximal end of the dilator rod is connected with a seat with a mechanical structure and a lock, so that the dilator rod and the matched catheter sheath are fixed in relative positions, and the phenomenon that the instrument is not conveyed in place due to dislocation of the instrument during the operation is prevented.
As described above, due to the limitations of the structure and materials of the existing devices, when the matched catheter needs to reach a distant lesion site and the device access path is tortuous, the delivery, safety and position accuracy of the conventional dilator system are difficult to meet such surgical requirements.
Disclosure of Invention
Aiming at the prior art, the invention provides an expander for interventional therapy equipment, which aims to solve the problem that the traditional equipment expander is poor in flexibility due to material and design structure defects, so that the vessel in a patient body is accidentally damaged; the equipment conveying range is small; low accuracy of catheter delivery position, etc.
In order to achieve the above purpose, the invention adopts the following technical scheme:
A dilator for an interventional therapy device, comprising: the dilator comprises a dilator rod, a first rod section, a second rod section and a third rod section, wherein the dilator rod is a hollow rod-shaped component, and comprises a first rod section, a second rod section and a third rod section in sequence from a distal end to a proximal end, and the first rod section comprises a tip; wherein the outer diameter of the second rod section of the expander rod is smaller than or equal to the outer diameter of the first rod section, and the outer diameter of the first rod section is smaller than or equal to the outer diameter of the third rod section; the hardness of the material of the first pole section and the second pole section is lower than that of the material of the third pole section.
As one embodiment of the invention, the inner diameter and outer diameter ratio A of the first pole section, the second pole section and the third pole section is that: b is more than or equal to 30 percent and less than or equal to 50 percent, wherein A is the inner diameter of the first rod section, the second rod section and the third rod section, and B is the outer diameter of the first rod section, the second rod section and the third rod section; the hardness of the materials of the first rod section, the second rod section and the third rod section is 25D-45D, wherein D is Shore hardness unit.
As one embodiment of the invention, the inner diameter and outer diameter ratio A of the first pole section, the second pole section and the third pole section is that: b is less than or equal to 70%, wherein A is the inner diameter of the first rod section, the second rod section and the third rod section, and B is the outer diameter of the first rod section, the second rod section and the third rod section; the hardness of the materials of the first rod section, the second rod section and the third rod section is 55D-72D, wherein D is Shore hardness unit.
As an embodiment of the present invention, the first pole segment, the second pole segment, and the third pole segment have equal outer diameters.
As an embodiment of the invention, the outer diameter of the second pole segment is smaller than the outer diameter of the first pole segment, and the outer diameter of the first pole segment is equal to the outer diameter of the third pole segment; or the outer diameter of the second pole segment is smaller than the outer diameter of the first pole segment, and the outer diameter of the first pole segment is smaller than the outer diameter of the third pole segment.
As one embodiment of the invention, a transition section is arranged between the second pole section and the first pole section and between the second pole section and the third pole section, and the slope angle of the transition section ranges from 10 degrees to 60 degrees.
As an embodiment of the invention, the tip of the first pole segment is conical with an angle in the range of 10 ° to 60 °.
As one embodiment of the invention, the outer diameter of the first pole section is larger than or equal to 3mm, and a gap of 0.076-0.36 mm is arranged between the outer diameter of the first pole section and the catheter of the interventional treatment device; the inner diameter of the first pole section is greater than or equal to 1mm.
As an embodiment of the invention, the outer diameter of the second pole segment is 0-3 mm smaller than the outer diameter of the first pole segment.
As one embodiment of the invention, the outer diameter of the third pole section is more than or equal to 3mm, and a gap of 0.08mm is arranged between the outer diameter of the third pole section and the catheter of the interventional treatment device; the inner diameter of the third pole section is more than or equal to 1mm.
As one embodiment of the present invention, the dilator seat is mounted on the outer surface of the third rod section, and the dilator seat includes a buckle, which fixes the dilator seat and the interventional therapy apparatus; the buckle is a wing mounted on the expander seat, and extends along the axial direction of the expander rod.
As an embodiment of the invention, the clasp comprises two first and second clasps circumferentially spaced 180 ° apart, wherein the tab end of the first clasp comprises a gripping mechanism projecting radially toward the central axis of the dilator stem.
In the technical scheme, the flexibility and the conveying performance of the dilator are optimized, and the large-caliber catheter/sheath can be conveyed to more tortuous in-vivo lesion positions, such as the heart, better; the catheter system is prevented from being difficult to advance due to the fact that the expander is too hard when the catheter system is excessively bent, and the damage to blood vessels of a human body caused by bending of the catheter system due to poor excessively bending capacity of the expander is avoided. The locking mechanism of the expander seat ensures that the relative position of the expander and the catheter is unchanged all the time in the conveying process, and the accuracy of the conveying position of the catheter is improved.
Drawings
FIG. 1 is a schematic diagram of a catheter system;
FIG. 2 is a schematic diagram of a three-stage dilator system;
FIG. 3 is a schematic diagram of a two-stage dilator system;
FIG. 4 is an exploded view of a three-stage dilator;
FIG. 5 is an exploded view of a two-stage dilator;
FIG. 6 is a block diagram of a three-stage dilator;
FIG. 7 is a schematic view of a transition section in an elliptical shape;
FIG. 8 is a schematic view of a transition section in a ramp shape;
FIG. 9 is a schematic illustration of a single-sided snap lock;
FIG. 10 is a schematic illustration of one-sided snap release;
FIG. 11 is a schematic illustration of a double sided snap lock;
fig. 12 is a schematic illustration of a double sided snap release.
In the figure: 1-dilator seat, 101-first buckle, 102-second buckle, 103-straight edge, 2-dilator rod, 201-first pole section, 202-second pole section, 203-third pole section, 3-hemostasis valve, 4-catheter.
Detailed Description
The technical solutions in the embodiments of the present invention are further clearly and completely described below with reference to the accompanying drawings and the embodiments. It is clear that the examples described are for the purpose of explaining the technical solution of the invention and are not meant to be exhaustive of all embodiments of the invention.
Examples of the embodiments are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements throughout or elements having like or similar functionality. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
With respect to the terms "distal/distal" and "proximal/proximal" in this specification, wherein proximal/proximal refers to the end proximal to the operator and distal/distal refers to the end distal to the operator, or into a human blood vessel. Each component may have a proximal end and a distal end, the proximal/distal end being a description of the relative direction/position and not directly representing the distance.
Referring to fig. 1, the present invention discloses a dilator for an interventional therapy device, which is connected to a hemostasis valve 3 of the interventional therapy device by a dilator seat 1, the hemostasis valve 3 being distally connected to a proximal end of a catheter 4. The dilator element mainly comprises: a dilator seat 1 and a dilator rod 2. The dilator seat 1 is connected to the proximal end of the dilator stem 2. The dilator is fixed with the hemostatic valve 3 through the locking structure of the dilator seat 1, and the dilator rod 2 is inserted into the catheter 4 through the hemostatic valve 3 to form a dilating system on the interventional therapy equipment.
Referring to fig. 2, 4 and 6, as a first embodiment of the expander rod 2 of the present invention, the expander rod 2 is a hollow rod-shaped member, which can be divided into three sections: the first shaft section 201 is distal with a transition section, the second shaft section 202 is a middle section with a relatively small outer diameter, the third shaft section 203 is proximal with a transition section that coincides with the inner diameter of the first shaft section 201, and the first shaft section 201 includes a tip. Referring to fig. 4, the proximal ends of the dilator seat 1 and the third stem segment 203 are bonded to form a dilator. The dilator seat 1 and the hemostatic valve 3 are mutually fixed through a locking structure, and the dilator rod 2 passes through the hemostatic valve 3 and a catheter 4 connected with the hemostatic valve, so that the dilator is arranged in the interventional therapy equipment.
Referring to fig. 6, in this example, the outer diameter of the second rod section 202 of the expander rod 2 is less than or equal to the outer diameter of the first rod section 201, and the outer diameter of the first rod section 201 is less than or equal to the outer diameter of the third rod 203 section. As one embodiment of the present invention, the ratio A:B of the inner and outer diameters of the second shaft section 202 of the expander shaft 2 is: a is more than or equal to 30 percent and B is less than or equal to 50 percent, wherein A is the inner diameter of the second rod section, and B is the outer diameter of the second rod section. The second pole segment 202 has a material hardness of 25D to 45D, where D is the Shore hardness unit. As another embodiment of the invention, the ratio of the inner diameter to the outer diameter of the second pole segment 202A to B is: 50% < A, B is less than or equal to 70%, where A is the inner diameter of the second pole segment 202 and B is the outer diameter of the second pole segment 202. The second pole segment 202 has a material hardness of 55D to 72D, where D is the Shore hardness unit.
The smaller outer diameter of the second pole segment 202 compared to the first pole segment 201 and the third pole segment 203 is to enhance flexibility of the expander to provide better over-bending performance, the material of the second pole segment 202 may be a hardness determined by the inner-outer diameter ratio (wall thickness), when the ratio of the inner diameter to the outer diameter is larger (a: B ratio), i.e. the wall thickness of the pole is smaller, the hardness of the material may be relatively increased, and when the ratio is smaller, i.e. the wall thickness is larger, the hardness of the material needs to be relatively softer. The same flexibility can also be achieved by the matching of materials of different hardness when the inner and outer diameter ratio of the rod, i.e. the wall thickness, is changed.
Table 1 illustrates some second pole segment 202 materials and wall thickness combinations, wherein the listed polyether block amide materials are from Arkema, france, as an embodiment of the present invention. The minimum bend diameter data in table 1 is obtained from a test by winding the second pole segment 202 180 ° around a particular cylindrical tool, and when the tool is removed, the second pole segment 202 is not bent and is determined to pass the corresponding outer diameter of the tool. The length of the second pole segment 202 is generally determined by the length of the tortuous path of the actual segment. As an application of the embodiment, for the pole section with 30 percent of internal-external diameter ratio (thicker wall thickness) made of PEBAX2533 material with softer material and the pole section with 50 percent of internal-external diameter ratio (thinner wall thickness) made of PEBAX6333 material with harder material, experimental data show that the flexibility of the pole section and the pole section is the same, namely the identical material requirement can be achieved no matter what collocation mode is selected,
Table 1 examples of the collocation of the second pole segment 202 material with the wall thickness.
Except for the second pole segment 202, the outer diameters of the first pole segment 201 and the third pole segment 203 are greater than or equal to 3mm, 0-0.076 mm greater than the outer diameter of the second pole segment 202. And a gap of 0.076-0.36 mm is arranged between the outer diameter of the first rod section 201 and the catheter 4 of the interventional therapy device; the third shaft section 203 has a gap of 0.08mm between the outer diameter and the catheter 4 of the interventional therapy device. The inner diameter of the first pole segment 201 and the third pole segment 203 is larger than or equal to 1mm, and the ratio range of the inner diameter to the outer diameter is 1:1.4 to 1:3.3. referring to fig. 7, the tip of the first pole segment is tapered with an angle (angle X shown in fig. 7) in the range of 10 ° to 60 °. The inner bore of the conical tip is also conical with an angle in the range of 10 deg. to 60 deg. coincident with the exterior. The bore diameter of the distal-most end of the tapered tip bore ranges from 0.88 to 1mm, which acts to conform to the guidewire guide.
With continued reference to FIG. 6, as one embodiment of the present invention, the first and third pole segments 201, 203 have an inside to outside diameter ratio A:B of: a is more than or equal to 30 percent and B is less than or equal to 50 percent, wherein A is the inner diameter of the first rod section 201 and the third rod section 203, and B is the outer diameter of the first rod section 201 and the third rod section 203. The hardness of the material of the first pole segment 201 and the third pole segment 203 is 25D-45D, wherein D is Shore hardness unit. As another embodiment of the present invention, when the material hardness choices are different, the inner diameter and outer diameter ratio a of the first pole segment 201, the third pole segment 203, B is: 50% < A, B is less than or equal to 70%, where A is the inner diameter of the first and third pole segments 201, 203 and B is the outer diameter of the first and third pole segments 201, 203. The hardness of the material of the first pole segment 201 and the third pole segment 203 is 55D-72D, wherein D is Shore hardness unit. In general, the first and second pole segments 201, 202 have a lower material hardness than the third pole segment 203.
The larger outer diameter of the first shaft section 201 compared to the second shaft section 202 serves to better fit the inner diameter of the catheter 4 and to seal off blood from entering the lumen of the catheter 4. Meanwhile, a certain gap is reserved between the outer diameter of the first rod section 201 and the inner diameter of the catheter 4 so as to ensure that the dilator is relatively smooth in pushing, the gap size is determined according to the integral hardness degree of the dilator rod 2, and if the dilator rod 2 is softer, the gap between the dilator rod 2 and the catheter 4 is larger, otherwise, the gap is smaller. The hardness of the material of the first pole segment 201 is adjusted according to the inner diameter and outer diameter ratio in the same way as the second pole segment 202.
For an embodiment of the invention, the materials and wall thickness collocations can be referred to table 2 below, wherein the polyether block amide materials listed are from Arkema, france, and the minimum bend diameter data are measured in the same manner as in table 1. Since the diameter of the first pole segment 201 is slightly larger than the second pole segment 202, the measured value of the minimum bend diameter is also slightly higher than the latter. It is thereby possible to demonstrate that the compliance requirements of the 201 pole segment are relatively low with respect to the second pole segment 202,
Table 2 examples of the collocation of the material and wall thickness of the first pole segment 201.
Compared with the first rod section 201 and the second rod section 202, the third rod section 203 has a larger outer diameter so as to ensure that the whole dilator has good pushing performance, and the thin and soft rod part can not completely transfer pushing force along the axial direction of the dilator during actual use, so that the dilator rod 2 is difficult to push in the blood vessel of a patient. In addition, because the third shaft segment 203 passes through a relatively straight path near the proximal penetration intersection, the requirement for softness is lower than for the segments 201 and 202, and therefore the material of the third shaft segment 203 will generally have a higher hardness than for the other two segments. The clearance between the outer diameter of the third section 203 and the inner diameter of the catheter 4 is determined according to the degree of softness of the whole expander shaft 2 in the same manner as the first section 201, in order to be smooth in the process of advancing and retracting the catheter 4. The hardness of the material of the third pole segment 203 is adjusted according to the ratio of the inner diameter to the outer diameter (A to B ratio).
For an embodiment of the invention, the materials and wall thickness collocations can be referred to table 3 below, wherein the polyether block amide materials listed are from the company Arkema, france, and the minimum bend diameter data are measured in the same manner as in table 1. Since the material hardness of the third pole segment 203 is slightly greater than that of the first pole segment 201, the measured value of the minimum bend diameter is slightly higher than the latter. This may be seen in that the compliance requirements of the third pole segment 203 are lower relative to the first pole segment 201. If high flexibility is desired for the third pole segment 203, reference is made to the outside diameter, material and wall thickness of the first pole segment 201,
Table 3 examples of the material and wall thickness collocation of the third pole segment 203.
Referring to fig. 7 and 8, there is a small transition at the junction of the proximal end of the first shaft segment 201 and the distal end of the second shaft segment 202 and the junction of the distal end of the third shaft segment 203 and the proximal end of the second shaft segment 202. The slope angle of the transition section ranges from 10 degrees to 60 degrees. The transition section may be elliptical in shape as shown at 201a in fig. 7, or may be sloped as shown at 201b in fig. 8, or may have other configurations with a gradual diameter change. The function of this transition structure is to cooperate with the switching structure of the hemostatic valve 3 of fig. 1 to direct the normal flow of blood as the dilator is advanced into and withdrawn from the hemostatic valve so that it does not cause the dilator stem 2 to become stuck in the hemostatic valve 3, affecting the procedure, due to the small blood reflux space created between the catheter 4 and the second stem segment 202 without the transition segment.
The first, second and third pole sections 201, 202, 203 may each be made of soft plastics such as PEBAX (polyether block polyamide), TPU (thermoplastic polyurethane elastomer rubber), LDPE (low density polyethylene), HDPE (high density polyethylene) or the like. The 4 materials are mainly selected because of lighter weight, good softness, strong elastic recovery capability, good stability and consistency at low temperature, good fatigue resistance, excellent processing performance and accurate dimensional stability compared with the traditional materials. The pipe is formed by extrusion or injection molding. The proximal end of the first pole segment 201 is then connected to the distal end of the second pole segment 202 by welding, bonding, or heat sealing; the proximal end of the second pole segment 202 is connected to the distal end of the third pole segment 203. The proximal end of the third rod segment 203 is attached to the dilator seat 1 by bonding.
As can be seen by combining the above parameters, in the first embodiment of the expander rod 2 of the present invention, the above combinations of material hardness may be varied as long as the material hardness of the first rod section and the second rod section is lower than that of the third rod section, and the values of the parameters for the first rod section, the second rod section and the third rod section are flexible and varied within the specific value ranges of the above tables 1 to 3. In addition, the hardness of the first, second and third pole segments is related to their respective inner and outer diameters.
For example, in the first expander, the first rod segment is selected to have a material hardness of 25D, an inner diameter of 1mm, an outer diameter of 3mm, and an inner diameter to outer diameter ratio of 33.3%. The second pole segment has a material hardness of 35D, an inner diameter of 0.9mm, an outer diameter of 2.95mm, and an inner diameter to outer diameter ratio of 30.5%. The third pole segment has a material hardness of 45D, an inner diameter of 1mm, an outer diameter of 3mm, and an inner diameter to outer diameter ratio of 33.3%. The inner diameter of the catheter matched with the first expander is 3.08mm, and a gap of 0.08mm is reserved between the catheter and the first rod section and the third rod section.
For example, in the second expander, the first rod segment is selected to have a material hardness of 55D, an inner diameter of 2.5mm, an outer diameter of 4.0mm, and an inner diameter to outer diameter ratio of 62.5%. The second pole segment has a material hardness of 63D, an inner diameter of 2mm, an outer diameter of 3mm, and an inner diameter to outer diameter ratio of 66.6%. The third pole segment has a material hardness of 72D, an inner diameter of 2.5mm, an outer diameter of 4.0mm, and an inner diameter to outer diameter ratio of 62.5%. The inner diameter of the catheter matched with the second dilator is 4.06mm, and a gap of 0.06mm is reserved between the catheter and the first rod section and the third rod section.
For example, in a third expander, the first rod segment is selected to have a material hardness of 25D, an inner diameter of 3.0mm, an outer diameter of 6.0mm, and an inner diameter to outer diameter ratio of 50.0%. The second pole segment has a material hardness of 45D, an inner diameter of 1.5mm, an outer diameter of 3.0mm, and an inner diameter to outer diameter ratio of 50.0%. The third pole segment has a material hardness of 72D, an inner diameter of 3.0mm, an outer diameter of 6.02mm, and an inner diameter to outer diameter ratio of 49.8%. The inner diameter of the conduit matched with the third expander is 6.08mm, and a gap of 0.08mm is arranged between the conduit and the first rod section; with a gap of 0.06mm between the third pole segment.
Referring to fig. 3 and 5, as another embodiment of the expander shaft 2 of the present invention, the expander shaft 2 is divided into three sections of comparable outer diameter dimensions, including a first distal shaft section 201, a third proximal shaft section 203, and a second intermediate shaft section 202 connecting the first and third shaft sections 201 and 203, similar to the conventional expander structure. The outer diameters of the first pole segment 201, the second pole segment 202, and the third pole segment 203 are equal. Referring to fig. 5, the proximal ends of the dilator hub 1 and the dilator shaft 2 are connected to form a dilator. The dilator seat 1 and the hemostatic valve 3 are mutually fixed through a locking structure, and the dilator rod 2 passes through the hemostatic valve 3 and a catheter 4 connected with the hemostatic valve 3, so that the dilator is arranged in the interventional treatment device.
With continued reference to fig. 3 and 5, the first pole segment 201, the second pole segment 202, and the third pole segment 203 are comparable in outside diameter dimension. The outer diameters of the first rod section 201, the second rod section 202 and the third rod section 203 are larger than or equal to 3mm, and a gap of 0.076-0.36 mm is reserved between the outer diameter of the first rod section 201 and the catheter 4 of the interventional treatment device. The outer diameter of the expander rod 2 and the inner diameter of the catheter 4 keep a certain gap so as to ensure that the expander is relatively smooth during pushing, the size of the gap is determined according to the integral hardness degree of the expander rod, and the gap is larger when the expander rod is soft, and is smaller otherwise. The inner diameter of the three-section rod is more than or equal to 1mm. The distal end of the first shaft segment 201 is a tapered tip having an angle in the range of 10 deg. to 60 deg., and the angle of the internal bore of the tapered tip is consistent with the outer diameter. The bore diameter of the most distal end of the tapered tip bore ranges from 0.88 to 1mm and acts to conform to the guidewire guide.
The first and second pole segments 201, 202 are of a relatively low durometer material and the third pole segment 203 is of a relatively high durometer material. The hardness of the material is selected according to the ratio of the inner diameter to the outer diameter (wall thickness). When the ratio of the inner diameter to the outer diameter is large (the wall thickness is small), the hardness of the material can be relatively improved, when the ratio is small (the wall thickness is large), the hardness of the material needs to be relatively softer, and the selection of the material can be carried out according to the actual situation by adopting the parameter configuration shown in tables 1-3.
The first and third pole segments 201 and 203 may each be made of soft plastics such as PEBAX (polyether block polyamide), TPU (thermoplastic polyurethane elastomer rubber), LDPE (low density polyethylene), HDPE (high density polyethylene), or the like. The pipe is formed by extrusion or injection molding. The proximal end of the first pole segment 201 may be joined to the distal end of the second pole segment 202 by welding, bonding, or heat sealing, among other processes. The proximal end of the third segment 203 is attached to the dilator base 1 with a locking mechanism by an adhesive or the like process. Other parts not mentioned are the same as those of the first embodiment.
As can be seen by comparing fig. 2 and 3, the three-section stem feature of fig. 2 is more beneficial for improving compliance of the expander stem 2. The primary factor in increasing compliance comes from the design of second rod end 202. The flexibility of the second rod end 202 greatly increases the flexibility of the first rod end 201 during travel. Through multiple experimental tests, the minimum diameter of the second rod end 202 that can pass (10 mm) in FIG. 2 is much smaller than the measured data (20 mm and 30 mm) for the other two rods, so the second rod end 202 itself is more compliant due to the choice of wall thickness and material. Second, in the configuration of FIG. 2, the differential design between the outer diameters of first rod end 201 and second rod end 202 is such that first rod end 201 has a greater amplitude of oscillation during patient vascular travel than in the configuration of FIG. 3. Therefore, the three-stage stent system of FIG. 2 can cope with more tortuous and complex vascular structures than the two-stage stent system of FIG. 3. These various combinations and their selection are within the scope of the present invention.
Referring to fig. 9-12, the spreader mount 1 is mounted and secured to the outer surface of the third pole segment 203. The expander seat 1 comprises a buckling structure, and the buckling structure fixes the expander seat 1 and the interventional therapy equipment. As an embodiment of the present invention, the snap-fit structure is a fin mounted to the spreader base 1 and extends axially along the spreader beam 2. The snap-fit arrangement of the spreader mount 1 comprises two first and second snaps 101, 102 spaced 180 ° apart, wherein the tab ends of the first snap 101 comprise a clamping mechanism protruding radially towards the centre axis of the spreader bar.
The dilator seat 1 and the hemostatic valve 3 are interconnected by a latch structure. The snap structure may be a single-sided structure as shown in fig. 9 and 10, or a double-sided structure as shown in fig. 11 and 12. Referring to fig. 12, the double-sided structure is a structure including both the first buckle 101 and the second buckle 102, and the single-sided structure includes only the first buckle 101, as shown in fig. 10, and the position of the second buckle 202 is changed to the straight edge 103.
Whether in a unilateral or bilateral structure, the clamping buckle of the expander seat 1 is pressed into the fixing groove of the hemostatic valve 3 to be fixed by an operator applying axial force during use, so that the clamped working state shown in fig. 9 and 11 is formed. The relative positions of the catheter 4 and the expander are fixed by interference fit between the buckles and the fixing grooves. In order to ensure that the interference can achieve the aim of preventing the expander from being withdrawn independently, the interference of the single-side buckle is appropriately larger than that of the double-side buckle. Compared with the traditional dilator, the upper side and the lower side of the dilator seat 1 are provided with the reinforcing ribs, so that the contact area between the dilator seat 1 and fingers is increased, and the problem that the dilator is pulled out from the operation of a doctor due to small friction force caused by the fact that the dilator seat 1 is small, blood and physiological saline adhere to the surface of the instrument in the operation and the like is prevented.
Referring to fig. 10, the purpose of the single-sided buckle is to know that the dilator has been inserted by the operator feeling the feel of the buckle and slot engagement once during surgery. The device has the advantages of convenient and quick use and relatively small pressure required to be applied. Referring to fig. 12, the purpose of the double-sided buckle is to make the operator feel the hand feeling when the buckle and the slot are engaged twice, and the operator needs to confirm that the buckles on both sides are locked and then use the buckle. The advantage of this is that the safety in use is high and the possibility of the catch loosening or withdrawing from the catch groove of the haemostatic valve 3 is low.
The expander seat 1 is mainly made of plastics such as PC (polycarbonate plastic), ABS (acrylonitrile butadiene styrene plastic) and nylon. The proximal end of the third segment 203 is attached to the dilator base 1 with a locking mechanism by an adhesive or the like process.
When the dilator of the present invention participates in the surgical procedure, the specific steps are as follows:
1. Evacuating the conduit 4;
2. Evacuating the expander stem 2;
3. The emptied dilator is inserted into the emptied catheter 4 until the dilator seat 1 and the hemostatic valve 3 are fixed through a locking structure to form a dilating system;
4. The expansion system follows the guide wire to pass through the access path until the catheter 4 and the expander reach the target position of the lesion in the patient;
5. After operation, the dilator seat 1 is pulled out towards the proximal end, so that the first buckle 101 and the second buckle 102 are separated from the interference fit clamping groove part of the hemostatic valve 3, and the dilator is pulled out slowly backwards until the dilator is completely pulled out. The whole use process of the dilator is completed.
In summary, the dilator of the present invention has the following beneficial effects:
1. the compliance and delivery efficiency of the dilator are optimized. By improving the structure and materials of the dilator bar 2 of the traditional interventional device, the large caliber catheter/sheath is better delivered to the more tortuous lesion position in the patient;
2. the safety of the interventional therapy equipment is improved. The catheter system is prevented from being difficult to advance because the expander rod part is too hard when the expander rod 2 is excessively bent in a patient, and the damage to blood vessels in the patient caused by bending of the catheter system due to poor excessively bending capacity of the expander rod 2 is avoided;
3. the locking mechanism of the dilator seat 1 improves the accuracy of the catheter delivery position. The interference fit between the locking mechanism and the hemostatic valve 3 ensures that the relative position of the dilator and the catheter 4 is unchanged all the time in the conveying process.
The specification uses specific words to describe embodiments of the specification. Reference to "one embodiment" and/or "some embodiments" means that a particular feature, structure, or characteristic is associated with at least one embodiment of the present description. Thus, it should be emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or an alternative embodiment "in various positions in this specification are not necessarily referring to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of the present description may be combined as suitable.
It will be appreciated by persons skilled in the art that the above embodiments are provided for illustration only and not for limitation of the invention, and that variations and modifications of the above described embodiments are intended to fall within the scope of the claims of the invention as long as they fall within the true spirit of the invention.
Claims (8)
1. A dilator for an interventional therapy device, comprising:
a dilator rod, which is a hollow rod-shaped component, and sequentially comprises a first rod section, a second rod section and a third rod section from a distal end to a proximal end, wherein the first rod section comprises a tip;
Wherein the outer diameter of the second pole segment is smaller than the outer diameter of the first pole segment, and the outer diameter of the first pole segment is equal to the outer diameter of the third pole segment; or the outer diameter of the second pole segment is smaller than the outer diameter of the first pole segment, and the outer diameter of the first pole segment is smaller than the outer diameter of the third pole segment, so that the second pole segment has better overstretching performance than the first pole segment and the third pole segment;
The material hardness of the first rod section is smaller than that of the third rod section, and the material hardness of the second rod section is smaller than or equal to that of the third rod section;
When the inner diameter and outer diameter ratio A of the first pole section, the second pole section and the third pole section is: when A is more than or equal to 30 percent and B is less than or equal to 50 percent, the hardness of the materials of the first rod section, the second rod section and the third rod section is 25D-45D;
When the inner diameter and outer diameter ratio A of the first pole section, the second pole section and the third pole section is: when the B is less than or equal to 70 percent in the ratio of 50 percent, the hardness of the materials of the first rod section, the second rod section and the third rod section is 55D-72D;
Wherein A is the internal diameter of first pole section, second pole section, third pole section, B is the external diameter of first pole section, second pole section, third pole section, D is Shore hardness unit.
2. The dilator for an interventional therapy device of claim 1, wherein: and a transition section is arranged between the second rod section and the first rod section and between the second rod section and the third rod section, and the slope angle of the transition section ranges from 10 degrees to 60 degrees.
3. The dilator for an interventional therapy device of claim 1, wherein: the outer diameter of the first rod section is larger than or equal to 3mm, and a gap of 0.076-0.36mm is reserved between the outer diameter of the first rod section and a catheter of the interventional treatment device; the end of the first pole segment comprises a section having an inner diameter of 0.88-1mm, the remainder of the first pole segment having an inner diameter greater than or equal to 1mm.
4. A dilator for an interventional therapy device according to claim 3, wherein: the outer diameter of the second pole segment is 0-3mm smaller than the outer diameter of the first pole segment.
5. The dilator for an interventional therapy device of claim 4, wherein: the outer diameter of the third rod section is more than or equal to 3mm, and a gap of 0.076-0.36mm is reserved between the outer diameter of the third rod section and the catheter of the interventional treatment device; the third pole segment has an inner diameter greater than or equal to 1mm.
6. The dilator for an interventional therapy device of claim 1, wherein: the tip of the first pole segment is tapered with an angle in the range of 10 ° -60 °.
7. The dilator for an interventional therapy device of claim 1, further comprising:
The expander seat is arranged on the outer surface of the third rod section and comprises a buckle, and the buckle is used for fixing the expander seat and interventional therapy equipment; the buckle is a wing panel arranged on the expander seat, and the buckle extends along the axial direction of the expander rod.
8. The dilator for an interventional therapy device of claim 7, wherein: the clasp comprises two first and second clasps circumferentially spaced 180 apart, wherein the tab end of the first clasp comprises a gripping mechanism that protrudes radially toward the central axis of the dilator stem.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211576730.7A CN115737010B (en) | 2022-12-09 | 2022-12-09 | Dilator for interventional therapy equipment |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211576730.7A CN115737010B (en) | 2022-12-09 | 2022-12-09 | Dilator for interventional therapy equipment |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN115737010A CN115737010A (en) | 2023-03-07 |
| CN115737010B true CN115737010B (en) | 2024-04-19 |
Family
ID=85345021
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211576730.7A Active CN115737010B (en) | 2022-12-09 | 2022-12-09 | Dilator for interventional therapy equipment |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115737010B (en) |
Citations (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0792660A2 (en) * | 1996-02-29 | 1997-09-03 | Medtronic, Inc. | Introducer system |
| US5902333A (en) * | 1993-04-13 | 1999-05-11 | Boston Scientific Corporation | Prosthesis delivery system with dilating tip |
| CN106714889A (en) * | 2014-09-04 | 2017-05-24 | 丝绸之路医药公司 | Methods and devices for transcarotid access |
| CN110392591A (en) * | 2017-01-10 | 2019-10-29 | 92号医疗公司 | Aspiration catheter system and application method |
| CN110913777A (en) * | 2017-07-13 | 2020-03-24 | 美敦力瓦斯科尔勒公司 | Collapsible dilator |
| CN111359077A (en) * | 2020-03-16 | 2020-07-03 | 巴特勒生物科技(苏州)有限公司 | Sheath core with quick guide function used in blood vessel interventional operation |
| CN111921070A (en) * | 2020-08-31 | 2020-11-13 | 武汉佑康科技有限公司 | Combined structure of sheath-entering expansion tube and ureteral sheath |
| CN112689525A (en) * | 2018-08-21 | 2021-04-20 | 美敦力瓦斯科尔勒公司 | Guide extension catheter assembly, system and method of use |
| CN113226224A (en) * | 2018-12-12 | 2021-08-06 | 爱德华兹生命科学公司 | Combined introducer and expandable sheath |
| WO2022147998A1 (en) * | 2021-01-07 | 2022-07-14 | 上海翰凌医疗器械有限公司 | Expansion tube, vascular sheath device, cooperation structure of vascular sheath device and pre-expander, and pre-expander |
| CN115068055A (en) * | 2022-05-25 | 2022-09-20 | 上海玮琅医疗科技有限公司 | Expander subassembly suitable for from expansion device |
| CN115397370A (en) * | 2020-02-27 | 2022-11-25 | 爱德华兹生命科学公司 | Expandable sheath with extruded section |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070185522A1 (en) * | 2003-01-21 | 2007-08-09 | Gareth Davies | Dilator |
| US8485969B2 (en) * | 2008-09-18 | 2013-07-16 | Jeffrey Grayzel | Medical guide element with diameter transition |
| WO2012094583A2 (en) * | 2011-01-07 | 2012-07-12 | C.R. Bard, Inc. | Shielding dilator for use with a catheter |
| US20210001091A1 (en) * | 2019-07-01 | 2021-01-07 | Gerald Ernst Schmidt | Remote access vascular and soft tissue tunneling dilator systems and methods of use |
-
2022
- 2022-12-09 CN CN202211576730.7A patent/CN115737010B/en active Active
Patent Citations (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5902333A (en) * | 1993-04-13 | 1999-05-11 | Boston Scientific Corporation | Prosthesis delivery system with dilating tip |
| EP0792660A2 (en) * | 1996-02-29 | 1997-09-03 | Medtronic, Inc. | Introducer system |
| CN106714889A (en) * | 2014-09-04 | 2017-05-24 | 丝绸之路医药公司 | Methods and devices for transcarotid access |
| CN110392591A (en) * | 2017-01-10 | 2019-10-29 | 92号医疗公司 | Aspiration catheter system and application method |
| CN110913777A (en) * | 2017-07-13 | 2020-03-24 | 美敦力瓦斯科尔勒公司 | Collapsible dilator |
| CN112689525A (en) * | 2018-08-21 | 2021-04-20 | 美敦力瓦斯科尔勒公司 | Guide extension catheter assembly, system and method of use |
| CN113226224A (en) * | 2018-12-12 | 2021-08-06 | 爱德华兹生命科学公司 | Combined introducer and expandable sheath |
| CN115397370A (en) * | 2020-02-27 | 2022-11-25 | 爱德华兹生命科学公司 | Expandable sheath with extruded section |
| CN111359077A (en) * | 2020-03-16 | 2020-07-03 | 巴特勒生物科技(苏州)有限公司 | Sheath core with quick guide function used in blood vessel interventional operation |
| CN111921070A (en) * | 2020-08-31 | 2020-11-13 | 武汉佑康科技有限公司 | Combined structure of sheath-entering expansion tube and ureteral sheath |
| WO2022147998A1 (en) * | 2021-01-07 | 2022-07-14 | 上海翰凌医疗器械有限公司 | Expansion tube, vascular sheath device, cooperation structure of vascular sheath device and pre-expander, and pre-expander |
| CN115068055A (en) * | 2022-05-25 | 2022-09-20 | 上海玮琅医疗科技有限公司 | Expander subassembly suitable for from expansion device |
Also Published As
| Publication number | Publication date |
|---|---|
| CN115737010A (en) | 2023-03-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6270484B1 (en) | Safety penetrating instrument with expandible portion and method of penetrating anatomical cavity | |
| US7211074B2 (en) | Valved catheter | |
| US7931669B2 (en) | Integrated vascular device with puncture site closure component and sealant and methods of use | |
| US8663196B2 (en) | Endovascular sheath with gradable stiffness device and method | |
| EP1709986A1 (en) | Integrated detachable introducer | |
| US20080065150A1 (en) | Method and Apparatus for Promoting Hemostasis of a Blood Vessel Puncture | |
| US8246585B2 (en) | Hemostatic clip | |
| US6976955B2 (en) | Handle for medical devices, and medical device assemblies including a handle | |
| JP2008512212A (en) | Expandable transseptal sheath | |
| JP2014509222A (en) | Intravenous catheter and insertion device with reduced blood scattering | |
| EP3769708B1 (en) | Medical device | |
| KR20120101677A (en) | Tissue closure devices, device and systems for delivery, kits and methods therefor | |
| WO2015146408A1 (en) | Catheter assembly and inner catheter | |
| KR20220138393A (en) | Inflatable sheath with interlock expander | |
| WO2021195243A1 (en) | Apparatus and method for septal punch | |
| EP3520724A1 (en) | Medical device and treatment method | |
| US6238404B1 (en) | Multipurpose medical device | |
| CN113507895A (en) | Apparatus and method for septum puncture | |
| CN213312821U (en) | Catheter sheath and expansion assembly | |
| CN115737010B (en) | Dilator for interventional therapy equipment | |
| US10010344B2 (en) | Self-dilating catheter introducer with obturator and method of use | |
| US20220080163A1 (en) | Balloon catheter | |
| WO2018163899A1 (en) | Puncture device, medical device, and treatment method | |
| US9681888B2 (en) | Wireguide set for changing access sites | |
| US9603601B2 (en) | Occlusion devices including dual balloons and related methods |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |