CN119034088A - Drug balloon dilation catheter and interventional medical instrument - Google Patents
Drug balloon dilation catheter and interventional medical instrument Download PDFInfo
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- CN119034088A CN119034088A CN202411535806.0A CN202411535806A CN119034088A CN 119034088 A CN119034088 A CN 119034088A CN 202411535806 A CN202411535806 A CN 202411535806A CN 119034088 A CN119034088 A CN 119034088A
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- 239000003814 drug Substances 0.000 title claims abstract description 119
- 229940079593 drug Drugs 0.000 title claims abstract description 117
- 230000010339 dilation Effects 0.000 title description 54
- 230000017531 blood circulation Effects 0.000 claims abstract description 162
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 53
- 239000011248 coating agent Substances 0.000 claims abstract description 19
- 238000000576 coating method Methods 0.000 claims abstract description 19
- 238000011144 upstream manufacturing Methods 0.000 claims abstract description 8
- 239000008280 blood Substances 0.000 claims description 14
- 210000004369 blood Anatomy 0.000 claims description 10
- 230000001154 acute effect Effects 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 4
- 230000003902 lesion Effects 0.000 description 30
- 239000007788 liquid Substances 0.000 description 13
- 239000012528 membrane Substances 0.000 description 8
- 208000031481 Pathologic Constriction Diseases 0.000 description 7
- 230000036262 stenosis Effects 0.000 description 7
- 208000037804 stenosis Diseases 0.000 description 7
- 230000002966 stenotic effect Effects 0.000 description 7
- 238000007789 sealing Methods 0.000 description 5
- 239000002775 capsule Substances 0.000 description 4
- 230000004308 accommodation Effects 0.000 description 3
- 238000004891 communication Methods 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 208000028867 ischemia Diseases 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000000916 dilatatory effect Effects 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000004165 myocardium Anatomy 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 210000005077 saccule Anatomy 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 206010057469 Vascular stenosis Diseases 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 230000002482 anti-endothelial effect Effects 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
本发明涉及介入式医疗器械的技术领域，提供了一种药物球囊扩张导管和介入式医疗器械，包括：管体、设置在所述管体上的球囊，以及涂布在所述球囊表面的药物涂层；所述管体内设置有输送通道和血流通道；所述输送通道和所述血流通道相互隔绝；所述球囊具有容置腔，所述输送通道与所述容置腔连通；所述血流通道与所述容置腔相互隔绝；所述血流通道包括：用于与所述球囊上游的血管连通的血流入口和用于与所述球囊下游的血管连通的血流出口。
The present invention relates to the technical field of interventional medical devices, and provides a drug balloon dilatation catheter and an interventional medical device, comprising: a tube body, a balloon arranged on the tube body, and a drug coating coated on the surface of the balloon; a delivery channel and a blood flow channel are arranged in the tube body; the delivery channel and the blood flow channel are isolated from each other; the balloon has a accommodating cavity, and the delivery channel is connected to the accommodating cavity; the blood flow channel is isolated from the accommodating cavity; the blood flow channel comprises: a blood flow inlet for communicating with a blood vessel upstream of the balloon and a blood flow outlet for communicating with a blood vessel downstream of the balloon.
Description
Technical Field
The invention belongs to the technical field of interventional medical instruments, and particularly relates to a drug balloon dilation catheter and an interventional medical instrument.
Background
For patients suffering from coronary or peripheral vascular stenosis, the current general treatment is percutaneous transluminal angioplasty, and as the operation progresses, cardiovascular "interventional no-implant" treatment calls for higher and higher, and drug balloons are used as representative therapeutic devices for "interventional no-implant", which are increasingly applied clinically. Specifically, the drug balloon is coated with special drugs (such as anti-endothelial hyperplasia, anti-inflammatory drugs and the like) on the balloon membrane of the balloon dilation catheter, the drug balloon is delivered to a target stenosis through the drug balloon dilation catheter, then the drug balloon is dilated, the drug balloon is expanded to open the lesion, the drugs on the surface of the balloon membrane can be tightly attached to the intima of a blood vessel, the drugs are released to the target stenosis in the continuous attaching process, and the drug balloon dilation catheter is withdrawn after the drugs are fully absorbed by the stenosis. Therefore, the medicine saccule realizes the reconstruction of blood circulation through the double treatment of physical expansion and drug inhibition restenosis, and the medicine saccule has proved the curative effect and the safety of complex lesions, small vascular lesions, bifurcation lesions, stent restenosis lesions and the like through a plurality of clinical researches. Compared with a bracket, the device has the advantage that implantation-free interventional therapy can be realized.
Referring to fig. 1, the balloon 2' of the currently used drug balloon dilation catheter is cylindrical (i.e. the balloon is in an expanded state) after being inflated, and the guide wire passes through the interior of the balloon. When the drug balloon is inflated, the balloon membrane will closely conform to the intima of the vessel over the entire 360 ° circumference. At this time, the lumen of the vessel in the balloon-expanded region is completely occluded and blood flow within the vessel is blocked, resulting in ischemia of the distal myocardium or tissue. In practice, in order to ensure that the drug on the surface of the balloon membrane is fully contacted and released with the lesion, it is generally necessary to keep the drug balloon in an expanded state for a long time (if not less than 1 min), which will lead to a long-term ischemia state of the far-end myocardium or tissue of the patient, thereby increasing the risk of the operation of the patient.
Disclosure of Invention
The invention aims to provide a drug balloon dilation catheter, which solves the technical problem that the drug balloon dilation catheter adopted clinically at present can block blood flow by long-time inflation and expansion Zhang Hui of a stenotic lesion.
The technical scheme includes that the drug balloon dilation catheter comprises a tube body, a balloon arranged on the tube body and a drug coating coated on the surface of the balloon, wherein a conveying channel and a blood flow channel are arranged in the tube body, the conveying channel and the blood flow channel are isolated from each other, the balloon is provided with a containing cavity, the conveying channel is communicated with the containing cavity, the blood flow channel is isolated from the containing cavity, and the blood flow channel comprises a blood flow inlet used for being communicated with a blood vessel at the upstream of the balloon and a blood flow outlet used for being communicated with the blood vessel at the downstream of the balloon.
Further, the delivery channel and the blood flow channel are sequentially formed from the proximal end to the distal end of the tube body by the lumen of the tube body.
Further, the blood flow channel penetrates through the balloon, the blood flow inlet is formed in the side wall of the tube body behind the balloon, and the blood flow outlet is formed in the side wall of the tube body in front of the balloon.
The balloon comprises a balloon body, a balloon body and a balloon body, wherein the balloon body comprises a first tube and a second tube, two ends of the first tube are respectively a first end and a second end, a lumen in the first tube forms a conveying channel, two ends of the second tube are respectively a third end and a fourth end, the lumen in the second tube forms a blood flow channel, the conveying channel comprises a conveying inlet and a conveying outlet, the conveying inlet is positioned on the first end, the conveying outlet is positioned on the second end, the blood flow inlet is positioned on the third end, the blood flow outlet is positioned on the fourth end, a through hole is formed in the side wall of the first tube, the third end stretches into the conveying channel through the conveying outlet, the edge of the blood flow inlet is fixedly connected with the edge of the through hole in a sealing mode, the blood flow inlet is communicated with the outer space of the first tube through the through hole, the balloon body is arranged on the first tube and/or the second tube, the accommodating cavity is communicated with the conveying outlet, the blood flow inlet is positioned behind the balloon body, and the balloon body is positioned behind the blood flow inlet.
The balloon is further provided with a cylindrical balloon body, a first opening and a second opening are respectively arranged at two ends of the cylindrical balloon body, the edge of the first opening is sleeved and fixed on the outer wall of the first tube or the edge of the first opening is fixedly connected with the edge of the conveying outlet in a sealing manner, the edge of the second opening is sleeved and fixed on the outer wall of the second tube, and the inner wall of the balloon body and the outer wall of the second tube form a containing cavity communicated with the conveying outlet.
Further, the accommodation chamber surrounds outside the blood flow channel.
Further, the balloon and the tube are an integral piece.
Further, the cross-section of the blood flow channel may have any one of a circular shape, a semicircular shape, an elliptical shape and a polygonal shape.
Further, the shape of the blood flow outlet may be any one of a circle, a semicircle, an ellipse, and a polygon.
Further, the blood flow guide device further comprises a first guide channel for a guide wire to pass through, the first guide channel is arranged on the fourth end, and the first guide channel and the blood flow channel are isolated from each other.
Further, the fourth end is located on the extending path of the blood flow channel, and the blood flow outlet is formed on the side wall of the fourth end.
Further, the number of blood flow outlets is one or more.
Further, the plurality of blood flow outlets are uniformly or randomly arranged.
Further, at least two of the blood flow outlets are oriented identically.
Further, at least two blood flow outlets are arranged outside the blood flow channel in a surrounding and orderly spaced mode, and in the direction surrounding the blood flow channel, the directions of any two adjacent blood flow outlets are arranged at an acute angle.
Further, the fourth end and the balloon are one piece.
Further, the novel guide wire comprises a guide wire and a first guide channel used for the guide wire to pass through, the first guide channel is arranged on the fourth end, and the guide wire passes through the first guide channel.
Further, the device further comprises a first guide pipe arranged on the fourth end, and the inner space of the first guide pipe forms the first guide channel.
Further, at least part of the first guide tube is arranged in parallel with the blood flow channel, or
The first guide tube is positioned in front of the blood flow channel.
Further, the first guide tube and the fourth end are a single piece.
Further, the device also comprises a second guide channel which is arranged on the balloon and used for the guide wire to pass through.
Further, the second guide channel passes through the interior of the balloon, and the second guide channel is isolated from the accommodation cavity.
Further, the second guide channel is located outside the balloon.
Further, a second guide tube is arranged on the outer surface of the balloon, and the inner space of the second guide tube forms the second guide channel.
Further, the balloon may be circumferentially covered outside the second guide channel after being deflated.
Further, the balloon can be folded into a plurality of petals after being exhausted, and one or more of the petals can be wrapped outside the second guide channel.
Further, each of the valve bodies has a chamber in communication with the balloon.
Further, each chamber is provided with a first inner wall and a second inner wall, and the first inner wall and the second inner wall can be mutually attached under external force extrusion so as to discharge the fluid in the chamber.
Further, after the balloon is deflated, a plurality of the petals may be spirally folded.
Further, the outer surface of the balloon is recessed to form a groove for the guide wire to pass through, and the inner space of the groove forms the second guide channel.
Further, flexible sheets are laid on the inner walls of the grooves.
The invention also provides an interventional medical device which comprises a pressure source and the drug balloon dilation catheter, wherein the pressure source is communicated with the conveying channel.
Compared with the prior art, the drug balloon dilation catheter has the advantages that the catheter body is provided with the conveying channel, the catheter body is provided with the blood flow channel, the conveying channel and the blood flow channel are isolated from each other, the catheter body is provided with the balloon, the balloon is internally provided with the accommodating cavity, the conveying channel is communicated with the accommodating cavity, liquid (or gas) is injected into the accommodating cavity of the balloon through the conveying channel to enable the balloon to expand, a user can convey the balloon into a blood vessel before the balloon expands, the blood vessel can be blocked after the balloon expands, the drug coating is arranged on the outer surface of the balloon, when the balloon expands, the drug coating on the surface of the balloon can be in contact with a lesion area on the inner wall of the blood vessel, so that the drug on the drug coating can be released to the lesion area on the inner wall of the blood vessel, the blood flow inlet of the blood flow channel can be communicated with the blood vessel at the upstream of the balloon, the blood flow outlet of the blood flow channel can be communicated with the blood vessel at the downstream of the balloon, so that the blood at the upstream of the balloon can still enter the downstream of the balloon through the channel after the balloon is blocked, the balloon can be prevented from contacting the lesion area in the blood flow process of the stenosis. In addition, after the drug coating on the balloon releases the drug to the stenotic lesion, if the liquid (or gas) in the balloon is discharged through the delivery channel, the contracted balloon can be taken out from the blood vessel.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic cross-sectional view of a prior art drug balloon dilation catheter in accordance with an embodiment of the present invention;
FIG. 2 is a schematic cross-sectional view of a drug balloon dilation catheter provided in an embodiment of the present invention;
FIG. 3 is a schematic cross-sectional view of a drug balloon dilation catheter (concealing blood vessels and lesions) according to an embodiment of the present invention;
FIG. 4 is a schematic cross-sectional view of a drug balloon dilation catheter and guidewire cooperation (concealing blood vessels and lesion areas) provided by an embodiment of the present invention;
FIG. 5 is an enlarged view of the portion A structure of FIG. 3;
FIG. 6 is a cross-sectional view taken along line B-B of FIG. 3;
FIG. 7 is a cross-sectional view taken along line C-C of FIG. 3;
FIG. 8 is a cross-sectional view taken along line D-D of FIG. 3;
FIG. 9 is a cross-sectional view taken along line E-E of FIG. 3;
Fig. 10 is an enlarged view of the K-section structure of fig. 4;
FIG. 11 is a schematic cross-sectional view of a drug balloon dilation catheter (concealing blood vessels and lesions) according to an embodiment of the invention;
FIG. 12 is a schematic cross-sectional view of a drug balloon dilation catheter and guidewire cooperation (concealing blood vessels and lesion areas) according to an embodiment of the present invention;
FIG. 13 is a cross-sectional view of the first embodiment taken along line H-H of FIG. 11 (balloon in inflated condition);
FIG. 14 is a cross-sectional view taken along line H-H of FIG. 11, showing the second structure (balloon in inflated state);
FIG. 15 is a cross-sectional view taken along line H-H of FIG. 11, in section, of the third balloon in a deflated state;
FIG. 16 is a cross-sectional view of the fourth block diagram taken along line H-H of FIG. 11 (balloon in contracted state);
FIG. 17 is a fifth cross-sectional view taken along line H-H of FIG. 11 (balloon in contracted state, valve body deployed);
FIG. 18 is a cross-sectional view taken along line H-H of FIG. 11, showing the second structure (balloon in inflated state);
FIG. 19 is a schematic cross-sectional view of a drug balloon dilation catheter according to an embodiment of the present invention (dashed arrows in the figures indicate blood flow);
FIG. 20 is an enlarged schematic view at A' in FIG. 19 (dashed arrows indicate blood flow direction);
FIG. 21 is an enlarged schematic view of FIG. 19 at B';
FIG. 22 is an enlarged schematic view at C' of FIG. 19 (dashed arrows indicate blood flow direction);
FIG. 23 is a third schematic cross-sectional view of a drug balloon dilation catheter and guidewire engagement provided in an embodiment of the present invention (dashed arrows in the figures indicate blood flow);
FIG. 24 is a schematic view of the hidden guidewire of FIG. 23 (dashed arrows in the figure indicate blood flow direction);
FIG. 25 is a schematic cross-sectional view of D '-D' of FIG. 24;
FIG. 26 is a schematic cross-sectional view of E '-E' in FIG. 24.
Wherein, each reference sign in the figure:
1-tube body, 11-first tube, 111-first end, 112-second end, 113-delivery channel, 1131-delivery inlet, 1132-delivery outlet, 114-through hole, 12-second tube, 121-third end, 122-fourth end, 123-blood flow channel, 1231-blood flow inlet, 1232-blood flow outlet, 2 '-balloon, 21-holding cavity, 22-valve body, 23-groove, 3-drug coating, 41' -guide wire, 42-first guide tube, 421-first guide channel, 4211-guide outlet, 5-second guide tube, 51-second guide channel, 6 '-blood vessel, 61' -lesion area, 7-flexible sheet.
Detailed Description
It should be noted that the specific examples are only for explaining the present invention and are not intended to limit the present invention.
It should be noted that, in the description of the embodiment of the present application, unless otherwise indicated, "/" means or, for example, a/B may represent a or B, and "and/or" herein is merely an association relationship describing an association object, which means that three relationships may exist, for example, a and/or B, and may mean that a exists alone, a and B exist together, and B exists alone. Wherein A and B may be singular or plural, respectively.
It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or indirectly connected to the other element. When an element is referred to as being "fixed" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element.
It should be noted that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate an orientation or a positional relationship based on that shown in the drawings, and are merely for convenience of description and to simplify the description, and do not indicate or imply that the apparatus or elements being referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the invention.
It should be noted that the terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implying a number of technical features being indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature.
It should be noted that the term "plurality" means two or more, unless specifically defined otherwise.
Wherein "distal" is understood to be the forward end portion of the tube 1 in the direction of advancement into the blood vessel. "proximal" is understood to mean the opposite end from the "distal" described above, and in actual operation is the end that is operated close to the human hand.
Where "anterior" is understood to mean the direction of advancement of the tube 1 into the vessel and "posterior" is understood to mean the other direction opposite to the above-mentioned "anterior".
Referring to fig. 2 to 10 together, a description will now be given of a drug balloon dilation catheter provided by the present invention. The drug balloon dilation catheter comprises a tube body 1, a balloon 2 arranged on the tube body 1 and a drug coating 3 coated on the surface of the balloon 2, wherein a conveying channel 113 and a blood flow channel 123 are arranged in the tube body 1, the conveying channel 113 and the blood flow channel 123 are isolated from each other, the balloon 2 is provided with a containing cavity 21, the conveying channel 113 is communicated with the containing cavity 21, the blood flow channel 123 is isolated from the containing cavity 21, and the blood flow channel 123 comprises a blood flow inlet 1231 used for being communicated with a blood vessel 6 at the upstream of the balloon 2 and a blood flow outlet 1232 used for being communicated with the blood vessel 6 at the downstream of the balloon 2.
In this way, the tube body 1 is provided with the conveying channel 113, the tube body 1 is provided with the blood flow channel 123, the conveying channel 113 and the blood flow channel 123 are isolated from each other, the tube body 1 is provided with the balloon 2, the balloon 2 is internally provided with the accommodating cavity 21, the conveying channel 113 is communicated with the accommodating cavity 21, liquid (or gas) is injected into the accommodating cavity 21 of the balloon 2 through the conveying channel 113 to enable the balloon 2 to expand, a user can convey the balloon 2 into the blood vessel 6 before the balloon 2 is expanded, the blood vessel 6 can be plugged after the balloon 2 is expanded, the outer surface of the balloon 2 is provided with the drug coating 3, when the balloon 2 is expanded, the drug coating 3 on the surface of the balloon 2 can be in contact with the lesion area 61 on the inner wall of the blood vessel 6, so that the drug on the drug coating 3 can be released to the lesion area 61 on the inner wall of the blood vessel 6, the blood flow inlet 1231 of the blood flow channel 123 can be communicated with the blood vessel 6 on the upstream of the balloon 2, the blood flow outlet 2 of the blood flow channel 123 can be communicated with the blood vessel 6 on the downstream of the balloon 2, after the balloon 2 is plugged by the user, the balloon 2 can be plugged into the blood vessel 6, the lesion area of the balloon 2 can be prevented from entering the blood vessel 6 on the blood vessel 6 through the channel 123 after the balloon 2 is expanded, and the lesion area is prevented from contacting the lesion area on the inner wall of the balloon 6. In addition, after the drug coating 3 on the balloon 2 releases the drug to the stenotic lesion 61, if the liquid (or gas) in the balloon 2 is discharged through the delivery channel 113, the contracted balloon 2 may be removed from the blood vessel 6.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon 2 dilating catheter provided by the present invention, a delivery channel 113 and a blood flow channel 123 are sequentially formed from the proximal end to the distal end of the tube body 1 from the inner cavity of the tube body 1. Thus, the delivery channel 113 and the blood flow channel 123 are sequentially arranged along the tube body 1, so that the space utilization is facilitated.
Further, referring to fig. 2 to 10, as a specific embodiment of the drug balloon 2 dilating catheter provided by the present invention, the blood flow channel 123 penetrates the balloon 2, the blood flow inlet 1231 is opened at the side wall of the tube body 1 behind the balloon 2, and the blood flow outlet 1232 is opened at the side wall of the tube body 1 in front of the balloon 2. In this way, blood may flow through balloon 2 through blood flow channel 123.
Further, referring to fig. 2 to 10, as a specific embodiment of the drug balloon dilation catheter provided by the invention, the catheter body 1 comprises a first tube 11 and a second tube 12, wherein two ends of the first tube 11 are respectively provided with a first end 111 and a second end 112, a lumen in the first tube 11 forms a delivery channel 113, two ends of the second tube 12 are respectively provided with a third end 121 and a fourth end 122, a lumen in the second tube 12 forms a blood flow channel 123, the delivery channel 113 comprises a delivery inlet 1131 and a delivery outlet 1132, the delivery inlet 1131 is positioned on the first end 111, the delivery outlet 1132 is positioned on the second end 112, the blood flow inlet 1231 is positioned on the third end 121, the blood flow outlet 1232 is positioned on the fourth end 122, a through hole 114 is formed in a side wall of the first tube 11, the third end 121 extends into the delivery channel 113 through the delivery outlet 1132, an edge of the blood flow inlet 1231 is fixedly connected with an edge of the through hole 114 in a sealing manner, the blood flow inlet 1 is communicated with an external space of the first tube 11 through the through hole 114, the balloon 2 is arranged on the first tube 11 and/or the second tube 12, and/or the delivery outlet 1232 is communicated with the delivery outlet 21. In one embodiment, the blood flow inlet 1231 is located behind the balloon 2 and the blood flow outlet 1232 is located in front of the balloon 2. In this way, the lumen in the first tube 11 forms the conveying channel 113, the side wall of the first tube 11 is provided with the through hole 114, the third end 121 of the second tube 12 extends into the conveying channel 113 from the conveying outlet 1132, the edge of the blood flow inlet 1231 on the third end 121 is fixedly connected with the edge of the through hole 114 in a sealing manner, external blood can enter the blood flow inlet 1231 through the through hole 114, the blood entering the blood flow inlet 1231 can be conveyed along the blood flow channel 123, the blood in the blood flow channel 123 can be discharged from the blood flow outlet 1232, and the first tube 11 can protect the second tube 12 positioned in the first tube 11.
In one embodiment, the fourth end 122 of the second tube 12 is located outside the delivery channel 113.
Further, referring to fig. 2 to 10, as a specific embodiment of the drug balloon dilation catheter provided by the invention, the balloon 2 is provided with a cylindrical balloon body, two ends of the cylindrical balloon body are respectively provided with a first opening and a second opening, the edge of the first opening is sleeved and fixed on the outer wall of the first tube 11 or the edge of the first opening is fixedly connected with the edge of the delivery outlet 1132 in a sealing manner, the edge of the second opening is sleeved and fixed on the outer wall of the second tube 12, and a containing cavity 21 communicated with the delivery outlet 1132 is formed between the inner wall of the balloon body and the outer wall of the second tube 12. In this way, the fixing of the capsule body is very convenient, only the first opening edge of the capsule body is sleeved and fixed on the outer wall of the first pipe 11 (or the first opening edge is fixedly connected with the edge of the conveying outlet 1132), the second opening edge of the capsule body is sleeved and fixed on the outer wall of the second pipe 12, and the conveying channel 113 can input liquid (or gas) into the accommodating cavity 21 to expand the capsule body.
In one embodiment, the first opening edge is fixed to the outer wall of the first tube 11 by means of welding.
In one embodiment, the second opening edge is secured to the outer wall of the second tube 12 by welding.
In one embodiment, the blood flow inlet 1231 is provided on the tube 1 outside the proximal end of the balloon 2, and may preferably be at a distance of not more than 10cm, i.e. less than or equal to 10cm, from the proximal weld of the balloon 2. The blood flow outlet 1232 may be preferably provided at the fourth end 122 of the tube 1 other than the distal end of the balloon 2. Blood flows from the blood flow inlet 1231 into the blood flow channel 123 inside the tube body 1 and flows out through the blood flow outlet 1232.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the accommodating cavity 21 surrounds the outside of the blood flow channel 123. In this way, the accommodation chamber 21 can protect the blood flow channel 123 from the outside of the blood flow channel 123.
Further, referring to fig. 2 to 10, as a specific embodiment of the drug balloon dilation catheter provided by the present invention, the balloon 2 and the tube 1 are integrated. In this way, the balloon 2 and the tube 1 are more secure.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the cross-section of the blood flow channel 123 may be any of circular, semicircular, elliptical and polygonal.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided in the present invention, the blood flow outlet 1232 may be any one of circular, semicircular, elliptical and polygonal.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the number of blood flow outlets 1232 is one or more. In this way, the blood in the blood flow channel 123 can be output from the plurality of blood flow outlets 1232 in a dispersed manner.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, a plurality of blood flow outlets 1232 are uniformly arranged or randomly arranged. In this manner, the blood flow is more evenly output from the plurality of blood flow outlets 1232.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, at least two blood flow outlets 1232 are oriented in the same direction. In this way, the blood in the blood flow channel 123 is not likely to interfere with each other when being output from the blood flow output port facing the same direction.
Further, referring to fig. 2 to 10, as a specific embodiment of the drug balloon dilation catheter provided by the present invention, at least two blood flow outlets 1232 are circumferentially and sequentially arranged at intervals outside the blood flow channel 123, and any two adjacent blood flow outlets 1232 are arranged at an acute angle between their orientations in the direction surrounding the blood flow channel 123. In this way, the blood in the blood flow channel 123 can be output to the outside through the different blood flow outlets 1232 with acute angles, so that the mutual interference between the blood flows discharged from the different blood flow outlets 1232 is reduced.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the fourth end 122 and the balloon 2 are integrated. In this way, the fourth end 122 is more secure with the balloon 2.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the drug balloon dilation catheter further comprises a guide wire 41 and a first guide channel 421 for the guide wire 41 to pass through, wherein the first guide channel 421 is arranged on the fourth end 122, the first guide channel 421 is isolated from the blood flow channel 123, and the guide wire 41 is arranged in the first guide channel 421 in a penetrating way. In this way, the guide wire 41 can pass through the first guide channel 421 to play a guiding role, so that the balloon 2 can conveniently enter the blood vessel 6 along the guide wire 41, and the first guide channel 421 is arranged on the fourth end 122, so that the influence of the balloon 2 on the passing of the guide wire 41 through the first guide channel 421 is reduced.
In one embodiment, a first guide channel 421 for the passage of the guidewire 41 is also included, the first guide channel 421 being provided on the fourth end 122. In this way, the guide wire 41 can pass through the first guide channel 421 to play a guiding role, so that the balloon 2 can conveniently enter the blood vessel 6 along the guide wire 41, and the first guide channel 421 is arranged on the fourth end 122, so that the influence of the balloon 2 on the passing of the guide wire 41 through the first guide channel 421 is reduced.
In one embodiment, the end of the first guide channel 421 adjacent to the balloon 2 has a guide outlet 4211.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the drug balloon dilation catheter further comprises a first guide tube 42 arranged on the fourth end 122, and the inner space of the first guide tube 42 forms a first guide channel 421. In this way, the guide wire 41 is conveniently threaded through the first guide tube 42.
In one embodiment, to ensure that the balloon 2 on the body 1 can successfully reach the stenotic lesion in the blood vessel, a first guide tube 42 for threading the guidewire 41 is provided outside the fourth end 122, and the drug balloon 2 is delivered to the target stenotic lesion 61 under the guidance of the guidewire 41. Because the first guide tube 42 is disposed on the fourth end 122, on one hand, the first guide tube 42 can be prevented from being flattened or collapsed due to the extrusion of the first guide tube 42 when the balloon 2 is expanded, and the guide wire 41 is prevented from being locked in the first guide tube 42, so that the catheter of the balloon 2 can be smoothly withdrawn from the blood vessel along the guide wire 41 when the operation is completed. On the other hand, the first guide tube 42 can be prevented from increasing the cross section of the entire balloon 2, and the trafficability of the balloon 2 at the stenotic lesion in the blood vessel can be effectively ensured.
In one embodiment, the fourth end 122 is provided with a first guide tube 42, and the length of the first guide tube 42 may preferably be set between 0.5 cm and 1.5cm to accommodate threading of the guidewire 41, which is advantageous for improving the flexibility of operation for movement in a blood vessel.
In one embodiment, the working principle of the drug balloon dilation catheter provided by the embodiment of the application is that firstly, the proximal end of a guide wire 41 is penetrated from the orifice at the distal end of a first guide tube 42 and is penetrated out from the orifice at the proximal end of the first guide tube 42, so that the first guide tube 42 at the distal end of the balloon 2 is completely sleeved on the guide wire 41, then the guide wire 41 and the balloon 2 are fed into a blood vessel 6 together, the guide wire 41 is delivered forward until the distal end of the guide wire 41 passes through a stenosis in the blood vessel 6, finally, the balloon 2 is delivered to a target stenosis region 61 under the guidance of the guide wire 41, secondly, the balloon 2 is inflated and expanded, the balloon 2 is gradually contacted with an inner membrane of the blood vessel 6 in the continuous inflation and expansion process, and the drug coating on the surface of the balloon 2 is tightly adhered to the inner membrane of the blood vessel 6 while the stenosis is expanded and opened. And finally, in the period of time when the balloon 2 is in the inflation and expansion state, the balloon 2 is closely attached to the inner membrane of the blood vessel 6, and no space is reserved between the balloon 2 and the inner membrane of the blood vessel 6 for blood to flow. At this time, the blood flow in the blood vessel 6 may enter the blood flow channel 123 through the blood flow inlet 1231, and the blood flow in the blood flow channel 123 may flow out from the blood flow outlet 1232. Allowing blood flow through the blood flow channel 123 to flow through the dilated (i.e., inflated) area of the balloon 2 avoids myocardial infarction or other adverse clinical symptoms in the patient during surgery due to myocardial or tissue ischemia.
Further, referring to fig. 19 to 26, as an embodiment of the drug balloon dilation catheter provided in the present invention, at least part of the first guide tube 42 is disposed parallel to the blood flow channel 123. Thus, when the fourth end 122 moves relative to the guidewire 41, the stress of the guidewire 41 and the fourth end 122 can be transmitted along the extending direction of the blood flow channel 123.
Referring to fig. 2 to 10, the first guide tube 42 is positioned in front of the blood flow channel 123. In this manner, the guidewire 41 passing through the first guide tube 42 may be guided in front of the blood flow channel 123.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the first guide tube 42 and the fourth end 122 are formed as a single piece. In this way, the first guide tube 42 is more firmly connected to the tube body 1.
Further, referring to fig. 2 to 10, as an embodiment of the drug balloon dilation catheter provided by the present invention, the drug balloon dilation catheter further comprises a second guide channel 51 provided on the balloon 2, and the guide wire 41 passes through the second guide channel 51. In this manner, the guidewire 41 may be passed through the second guide channel 51 of the balloon 2, and the second guide channel 51 may provide a delivery space for the guidewire 41.
Further, referring to fig. 13, as an embodiment of the drug balloon dilation catheter provided by the present invention, the second guide channel 51 passes through the interior of the balloon 2, and the second guide channel 51 is isolated from the accommodating cavity 21. In this way, the guide wire 41 does not easily interfere with the substance outside the balloon 2 when passing through the second guide passage 51.
Further, referring to fig. 14, as an embodiment of the drug balloon dilation catheter provided by the present invention, the second guide channel 51 is located outside the balloon 2. In this way, occupation of the inner space of the balloon 2 by the second guide passage 51 is avoided.
Further, referring to fig. 14, as a specific embodiment of the drug balloon dilation catheter provided by the present invention, a second guide tube 5 is provided on the outer surface of the balloon 2, and the inner space of the second guide tube 5 forms a second guide channel 51. Thus, the second guide channel 51 is formed in the shape of the second guide tube 5, the structure is simple, and the second guide tube 5 does not occupy the inner space of the balloon 2.
Further, referring to fig. 11 to 15, as an embodiment of the drug balloon dilation catheter provided by the present invention, the balloon 2 may be circumferentially covered outside the second guide channel 51 after being deflated. In this way, the balloon 2 is deflated and folded around the outside of the second guide channel 51 to protect the guidewire 41 in the second guide channel 51.
Further, referring to fig. 15 and 17, as an embodiment of the drug balloon dilation catheter provided by the present invention, the balloon 2 may be folded into a plurality of petals 22 after being deflated, wherein one or more petals 22 may be wrapped outside the second guide channel 51. Therefore, the plurality of petals 22 can be wrapped outside the second guide channel 51 for protection, and the balloon 2 can be folded into the plurality of petals 22 after being exhausted, so that the balloon 2 can be conveniently stored, and the occupation of space is reduced.
Further, referring to fig. 15, as an embodiment of the drug balloon dilation catheter provided by the present invention, each of the petals 22 has a chamber in communication with the balloon 2. As such, the petals 22 may expand (or unfold) after injecting liquid (or gas) into the chamber, and the petals 22 may collapse (or fold) after withdrawing liquid (or gas) from the chamber.
Further, referring to fig. 15, as a specific embodiment of the drug balloon dilation catheter provided by the invention, each chamber is provided with a first inner wall and a second inner wall, and the first inner wall and the second inner wall can be mutually attached under the extrusion of external force so as to discharge the fluid in the chamber. Thus, after the liquid (or gas) in the chamber is pumped away, the first inner wall and the second inner wall can be mutually attached to reduce the volume of the flap body 22, and the first inner wall and the second inner wall can be mutually attached to facilitate the direct transfer of stress between the inner walls of the flap body 22. In one embodiment, the fluid is a liquid or a gas.
Further, referring to fig. 15, as an embodiment of the drug balloon dilation catheter provided by the present invention, after the balloon 2 is deflated, the plurality of petals 22 may be spirally folded. In this way, the plurality of petals 22 can be conveniently stored, and the respective relative positions of the petals 22 can be more stably maintained by static friction force between the screw type mutually folded petals 22.
Further, referring to fig. 18, as an embodiment of the drug balloon dilation catheter provided by the present invention, the outer surface of the balloon 2 is concavely formed with a groove 23 for the guide wire 41 to pass through, and the inner space of the groove 23 forms a second guide channel 51. Thus, the guide wire 41 can pass through the groove 23, the groove 23 has a simple structure, and the guide wire 41 is clamped in the groove 23, so that the position of the guide wire 41 is easy to keep stable.
Further, referring to fig. 18, as an embodiment of the drug balloon dilation catheter provided by the present invention, flexible sheets 7 are laid on the inner walls of the grooves 23. In this way, the flexible sheet 7 can reduce friction between the guide wire 41 and the inner wall of the groove 23, and also reduce abrasion of the guide wire 41 against the inner wall of the groove 23.
The invention also provides an interventional medical device comprising a pressure source and a drug balloon dilation catheter, the pressure source being in communication with the delivery channel 113. In this way, the drug balloon dilation catheter is adopted, the catheter body 1 is provided with the conveying channel 113, the catheter body 1 is provided with the blood flow channel 123, the conveying channel 113 and the blood flow channel 123 are isolated from each other, the catheter body 1 is provided with the balloon 2, the balloon 2 is internally provided with the accommodating cavity 21, the conveying channel 113 is communicated with the accommodating cavity 21, liquid (or gas) is injected into the accommodating cavity 21 of the balloon 2 through the conveying channel 113, the balloon 2 can be inflated, a user can convey the balloon 2 into the blood vessel 6 before the balloon 2 is inflated, the blood vessel 6 can be blocked after the balloon 2 is inflated, the drug coating 3 is arranged on the outer surface of the balloon 2, when the balloon 2 is inflated, the drug coating 3 on the surface of the balloon 2 can be in contact with the lesion area 61 on the inner wall of the blood vessel 6, so that the drug on the drug coating 3 can be released onto the lesion area 61 on the inner wall of the blood vessel 6, the blood flow inlet 1231 of the blood flow channel 123 can be communicated with the blood vessel 6 on the upstream of the balloon 2, the blood flow outlet 1232 of the blood flow channel 123 can be communicated with the blood vessel 6 on the downstream of the balloon 2, the balloon 2 can be communicated with the blood vessel 6 on the blood flow channel 2, the user can be blocked by the balloon 2, the drug coating 2 can be prevented from entering the lesion area on the blood vessel 6 on the inner wall of the balloon 2 after the balloon 2 is inflated, and the lesion area 3 can be prevented from contacting the lesion area on the upper lesion area 61 on the inner wall of the balloon 2. In addition, after the drug coating 3 on the balloon 2 releases the drug to the stenotic lesion 61, if the liquid (or gas) in the balloon 2 is discharged through the delivery channel 113, the contracted balloon 2 may be removed from the blood vessel 6.
In one embodiment, the pressure source is a liquid supply source that communicates with the delivery channel 113 to inject or drain liquid into the delivery channel 113.
In one embodiment, the pressure source is a gas supply source that communicates with the delivery channel 113 to inject or exhaust gas into the delivery channel 113.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and substitutions can be made by those skilled in the art without departing from the technical principles of the present invention, and these modifications and substitutions should also be considered as being within the scope of the present invention.
Claims (26)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202411535806.0A CN119034088A (en) | 2024-10-31 | 2024-10-31 | Drug balloon dilation catheter and interventional medical instrument |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202411535806.0A CN119034088A (en) | 2024-10-31 | 2024-10-31 | Drug balloon dilation catheter and interventional medical instrument |
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| Publication Number | Publication Date |
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| CN119034088A true CN119034088A (en) | 2024-11-29 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202411535806.0A Pending CN119034088A (en) | 2024-10-31 | 2024-10-31 | Drug balloon dilation catheter and interventional medical instrument |
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| CN (1) | CN119034088A (en) |
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2024
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