CN211434679U - Medicine-feeding balloon assembly and medical instrument comprising same - Google Patents
Medicine-feeding balloon assembly and medical instrument comprising same Download PDFInfo
- Publication number
- CN211434679U CN211434679U CN201922049775.9U CN201922049775U CN211434679U CN 211434679 U CN211434679 U CN 211434679U CN 201922049775 U CN201922049775 U CN 201922049775U CN 211434679 U CN211434679 U CN 211434679U
- Authority
- CN
- China
- Prior art keywords
- balloon
- concave arc
- longitudinal
- catheter
- assembly
- 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
Images
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The application provides a balloon subassembly for administration and medical instrument that contains it, it includes: the balloon catheter comprises a balloon catheter (1) and a balloon (2) arranged on the catheter, wherein the longitudinal section of the balloon (2) has a concave arc-shaped profile (25) when the balloon is fully expanded, and a medicine composition or a medicine composition layer (4) is arranged on the surface of an area with the concave arc-shaped profile (25). The utility model discloses a balloon component for dosing combines current apparatus to handle the fistula, can realize that interatrial fistula lasts open, prevents that interatrial fistula is just closed naturally in short-term, reaches the effect that reduces heart preload, treatment heart failure for a long time.
Description
Technical Field
The invention relates to the technical field of medical treatment, in particular to a balloon component for administration and a medical apparatus comprising the same.
Background
Interatrial septum fistulation is a well established technique in patients with advanced pediatric congenital heart disease, pulmonary hypertension. It is also applied to patients with diastolic dysfunction, heart failure and systolic dysfunction with continuous elevation of PCWP, and has a remarkable effect, but it is not formally developed clinically. The current research shows that the fistula can be naturally healed after 6 months no matter a stent is placed in the fistula or not after the interatrial fistula is made, so that the operation effect is greatly reduced. Therefore, how to avoid the natural closure of the fistula in a short period is the key to ensure the final treatment effect of the interatrial septum ostomy.
SUMMERY OF THE UTILITY MODEL
The heart medicine balloon is a new technology, and the medicine is uniformly distributed on the blood vessel wall by implanting the special balloon coated with paclitaxel, so as to inhibit the hyperplasia of the blood vessel endothelium and smooth muscle and prevent restenosis. The cardiac drug balloon can solve the problem of vascular stenosis without implanting a stent, and is an emerging treatment method. However, the existing drug balloons are designed for preventing the endothelial hyperplasia of coronary arteries and peripheral large blood vessels, and no balloon specially for healing the fistula, particularly the interatrial fistula with the thickness of only 2-3 mm is provided.
The application discloses give medicine and use sacculus subassembly combines current apparatus to handle the fistula, can realize that interatrial fistula is continuous open, solves the problem of interatrial fistula in short-term just closed naturally to reach the long-term purpose that reduces heart preload, treatment heart failure.
The technical scheme disclosed by the application comprises the following implementation modes:
Embodiment 3 the balloon assembly for administration according to embodiment 1, wherein the balloon catheter has a guide wire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel communicates with the inside of the balloon.
Embodiment 5 the balloon assembly for drug administration according to embodiment 1, wherein the concave arc-like profile is formed at a longitudinal front portion and/or a longitudinal rear portion of the balloon, and the concave arc-like profile starts from a position radially close to the balloon catheter to end at a radially middle portion of the balloon.
Embodiment 6 the balloon assembly for administration according to embodiment 1, wherein the longitudinal dimension of the balloon is 2/3 or less (1/2 or less) of its radial dimension, such that when the balloon is folded, the area having the concave arc-like profile is mostly folded inside, thereby avoiding loss of the drug during pushing of the balloon assembly.
Embodiment 7 the balloon assembly for administration according to embodiment 1, wherein the pharmaceutical composition comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier. The drug carrier comprises a hydrophilic drug carrier.
Embodiment 8 the balloon assembly for administration according to any one of embodiments 1 to 7, wherein the balloon assembly comprises two balloons, the concave arc-shaped profile of one balloon is formed at a longitudinal front portion of the balloon, and the concave arc-shaped profile of the other balloon is formed at a longitudinal rear portion of the balloon.
Embodiment 9, the balloon assembly for administration of any of embodiments 1-8, wherein the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.
Embodiment 10, a medical device, in particular for percutaneous interatrial ostomy intervention, comprising a balloon assembly according to any of embodiments 1-9.
The subject of this application combines current apparatus (for example cutting sacculus etc.) to handle the fistula, can realize dosing to interatrial fistula and surrounding part, especially can make interatrial fistula continuously open, solves the problem that interatrial fistula is just closed naturally in short-term to reach the long-term heart preload that reduces, the purpose of treatment heart failure.
Drawings
To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.
Fig. 1 shows a schematic view of the balloon assembly in a folded state;
fig. 2 shows a schematic view of the concave arc-like profile located at the longitudinal front of the balloon;
FIG. 3 shows a schematic view of the concave arc-like profile located longitudinally rearward of the balloon;
FIG. 4 shows a schematic view of the concave arc profile in the longitudinal middle of the balloon;
fig. 5 and 6 show a schematic view of the folding of the balloon assembly.
Fig. 7 shows a schematic view of the concave arc profile carrying a drug composition or drug composition layer.
Reference numerals: 1-balloon catheter, 11-balloon catheter front end, 12-balloon catheter front portion, 13-guide wire through hole, 14-pressurizing liquid channel, 2-balloon, 21-balloon front end, 22-longitudinal front portion, 23-longitudinal middle portion, 24-longitudinal back portion, 25-concave arc profile, 251-position near balloon catheter, 252-radial middle portion, 3-cannula, 4-pharmaceutical composition or pharmaceutical composition layer.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.
The following terms in this application have the specific meanings:
the direction along the catheter is defined herein as "longitudinal" and the direction perpendicular to the catheter is defined herein as "radial" and the balloon expands primarily in the radial direction.
In the present application, a portion which first reaches the region to be processed when used is defined as "front", and an orientation opposite to "front" is defined as "rear".
In this application, the terms "end" and "section" are used to describe the balloon and specific portions of the balloon catheter, where "end" refers to a defined end point or end surface and "section" is used to describe a range of regions.
For example, the "leading end" of a balloon catheter means that the balloon catheter first reaches the end point or end surface of the area to be treated when in operation, and the "leading end" of a balloon means that the balloon first reaches the end point or end surface of the area to be treated when in operation.
For example, the "front" of a balloon catheter refers to a range of the balloon catheter relative to the distal end of the operator, and the "longitudinal front", "longitudinal middle", and "longitudinal back" of the balloon refer to three regions of the balloon body ranging from the distal end to the proximal end relative to the operator in the direction of the balloon catheter, for example, the front refers to front 1/4, the back refers to back 1/4, and the middle refers between front 1/4 and back 1/4.
In the present application, each term has a meaning commonly understood in the art unless otherwise indicated or otherwise clearly understood from the context.
The application discloses give medicine and use sacculus subassembly, it includes: the balloon catheter comprises a balloon catheter and a balloon arranged on the catheter, wherein a longitudinal section of the balloon has a concave arc-shaped profile when the balloon is fully expanded, and a medicinal composition is arranged on the surface of an area with the concave arc-shaped profile. In the present application, the term "longitudinal section" refers to a section along the direction of the catheter, and the term "concave arc" refers to an arc surface of the balloon opposite to the direction of expansion of the balloon when the balloon is expanded. When the medical composition is arranged, the concave arc-shaped area can have a wider contact area when being contacted with the area to be treated, so that the medicine can be better released to the area to be treated, and a better treatment effect is achieved. The present application uses parameters common in the art for the length of the balloon catheter, which is typically 1.8F-2.0F in diameter. The unit F here has the meaning generally understood by those skilled in the art, 1F means a catheter having a circumference of 1 mm, 1.8F means a catheter having a circumference of 1.8 mm, and 2.0F means a catheter having a circumference of 2.0 mm.
In some embodiments, the concave arc-like profile is formed in at least one of a longitudinal anterior portion, a longitudinal posterior portion, and a longitudinal middle portion of the balloon. Different arrangement modes of the concave arc-shaped profile can produce different treatment effects. In the case where a concave arc-shaped profile is formed at the longitudinal front portion of the balloon, the region provided with the pharmaceutical composition can treat one face of the interatrial septum at the stoma, and in cooperation with the balloon assembly in which a concave arc-shaped profile is formed at the longitudinal rear portion of the balloon, can treat both faces of the interatrial septum at the stoma. In the case where a concave arc-shaped contour is formed in the longitudinal middle of the balloon, the concave arc-shaped region corresponds to the stoma, and it is possible to treat both sides of the interatrial septum at the stoma at the same time.
In some embodiments, the balloon catheter has a guidewire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel is in communication with the balloon interior. The arrangement of the guide wire through hole can lead the balloon catheter to reach the selected area to be treated along the guide wire under the guide of the guide wire for treatment. The pressurizing liquid channel is used for injecting or extracting pressurizing liquid into or from the saccule, after the saccule reaches a target area, the pressurizing liquid is injected into the pressurizing liquid channel, the saccule is expanded under the action of hydraulic pressure, when the pressurizing liquid is extracted after administration treatment is finished, negative pressure is generated in the saccule, and the contraction and folding of the saccule are finished under the action of the negative pressure. Typically, for accurate positioning, markers (marker materials) are also provided inside the balloon, which are used to help an external device detect its position within the patient. In the present application, the selection of the balloon position marker is not particularly limited as long as the balloon position can be accurately positioned.
In some embodiments, the balloon is disposed at the front of the balloon catheter, and the distance from the front end of the balloon catheter is about 5 to 20 mm.
In some embodiments, the concave arc profile is formed at a longitudinal anterior portion and/or a longitudinal posterior portion of the balloon, the concave arc profile beginning radially proximal to the balloon catheter and ending at a radially central portion of the balloon. By "proximate to the balloon catheter" in this application is meant in the range from the surface of the balloon catheter to a radial first distance from the centerline of the balloon catheter, the radial first distance being about 1.5mm to about 2.5 mm. When the concave arc-shaped profile is formed at the longitudinal front part of the balloon, the longitudinal distance from the position close to the balloon catheter to the front end of the balloon catheter is preferably not more than 20mm, and the longitudinal distance from the position close to the balloon catheter to the front end of the balloon is preferably 5mm to 20 mm. By "radially intermediate" is meant herein the region that is at a perpendicular distance from the centerline of the catheter when the balloon is fully expanded from 1/4 or greater to 3/4 or less of the specified range of balloon radii. In the present application, "balloon radius" refers to a perpendicular line perpendicular to the center line of the balloon catheter from the radially outermost end point of the expansion when the balloon is fully expanded, and the length of the perpendicular line is the balloon radius. It should be noted that the range of the concave arc-shaped profile is limited from the position radially close to the balloon catheter to the radial middle end of the balloon, the range depends on the range of a drug administration target area, the stoma expansion diameter of the balloon is about 5mm by adopting the three-side fixed blade to cut in the interatrial septum fistulization interventional therapy, and the maximum stoma expansion diameter can reach 12mm by combining other balloons, and according to the clinical treatment experience of congenital heart disease, the target size is reached when the stoma diameter is about 5-8 mm, and the left atrial pressure can be effectively reduced. However, the above dimensions are not limitations to the size of the balloon assembly disclosed in the present invention, and those skilled in the art can select an appropriate range of the concave arc-shaped profile according to actual needs, for example, an appropriate radial first distance according to the stoma diameter, and further an appropriate radial middle dimension according to the administration target area, thereby achieving the best administration effect.
In a preferred embodiment, the radial first distance is 2.5mm, and the radial middle part is 6.25mm or more, for example, 6.25mm to 10mm, from the center line of the balloon catheter, which is the preferred dimension for the present invention to achieve the optimal therapeutic effect, and is not limited by the disclosure of the present invention.
In some embodiments, the longitudinal dimension of the balloon is 2/3 or less (1/2 or less) of its corresponding radial dimension. In the present application, the distance between two end points in the longitudinal direction of a significant portion of the balloon is the longitudinal dimension when the balloon is fully expanded; the distance between two end points of the balloon in the radial direction is the radial dimension, and is usually twice the radius of the balloon. Significant portions as described herein refer to portions on the balloon having a radial distance greater than 1/4 balloon radius; and the distance between the two end points in the longitudinal direction of a significant portion of the balloon refers to the distance between the front end and the rear end of the portion of the balloon having a radial distance greater than 1/4 balloon radius. On the one hand, the size design enables the area with the concave arc-shaped profile to be mostly or completely folded into the inside when the balloon is folded, thereby avoiding the loss of the medicine due to dissolution in the pushing process of the balloon component. On the other hand, the balloon assembly disclosed by the application is mainly used for solving the technical problem of natural closure of the interatrial fistula, the area to be treated is a plane within a certain range around the fistula, and the size is designed to ensure that the balloon is flat in the longitudinal direction when the balloon is fully expanded, so that the balloon adapts to the internal space of the heart and generates a sufficient administration area. As a general arrangement of the invention, the longitudinal dimension of the balloon is typically 5mm to 16mm, for example 7.5mm to 13 mm. As a general arrangement of the invention, the radial dimension of the balloon is typically 10mm to 25mm, for example 15mm to 20 mm.
In some embodiments, the pharmaceutical composition comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier. The drugs, pharmaceutical carriers, and pharmaceutical compositions employed herein are known to those skilled in the art. The drug carrier preferably comprises a hydrophilic drug carrier and/or a hydrophobic drug carrier. The hydrophilic drug carrier is at least one selected from iopamidol and iopromide. The existing drug-coated balloon (DCB) interventional therapy technology attaches drugs for inhibiting cell proliferation on the surface of the balloon, attaches the drug surface to the interatrial fistula and the periphery by expanding the balloon, and transmits the drugs to a target point so as to achieve the effect of inhibiting smooth muscle proliferation. Paclitaxel and rapamycin have the function of inhibiting cell proliferation, and are widely applied to the field of coronary artery and peripheral interventional therapy in clinic, the two drugs are lipophilic drugs, the lipophilic drugs paclitaxel and/or rapamycin and the hydrophilic drug carrier iopamidol and/or iopromide are combined randomly to form the pharmaceutical composition, and the hydrophilic drug carrier can form a porous coating with a high contact surface between lipophilic drug molecules and a blood vessel wall, so that the dissolution and release of the lipophilic drug molecules are enhanced, and the drug delivery and the interaction between the lipophilic drug molecules and tissues can be changed. The medicinal composition is loaded on the surface of the concave arc-shaped contour area of the balloon component disclosed by the application as a balloon coating, after the balloon is expanded, the concave arc-shaped contour area loaded with the medicinal composition is completely contacted with an area to be treated, the target medicament dose is uniformly and quickly released, and clinical experience shows that the medicinal composition only needs 30 to 70 seconds of short-time contact and is enough to inhibit cell proliferation and prevent peripheral endothelium from creeping and fistula from naturally healing.
In some embodiments, the balloon assembly comprises two balloons, the concave-arc profile of one balloon being formed at a longitudinal anterior portion of the balloon and the concave-arc profile of the other balloon being formed at a longitudinal posterior portion of the balloon. Thus, both sides of the interatrial septum at the stoma may be treated by pushing the balloon assemblies separately to the area to be treated.
In some embodiments, the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon. Compliance of the balloon as described herein refers to the characteristic of the balloon profile or volume change that occurs with each increase in atmospheric pressure (atm) when the balloon is inflated, and is an indicator of the ability of the balloon to stretch. Three different types of balloons employed in this application possess different characteristics: the balloon diameter of the compliant balloon increases with increasing pressure, the compliant balloon dispersing the inflation pressure; the non-compliant balloon means that no matter how much the diameter of the pressure balloon is added, the diameter of the pressure balloon keeps unchanged after reaching the specified size, the expansion pressure of the non-compliant balloon is intensively acted on a treatment part, and the non-compliant balloon has weak adaptability to blood vessels; the semi-compliant balloon has a wide working range, can flexibly control the size of the balloon, and is mainly used for pre-expansion. In practical application, a person skilled in the art can select different balloons according to actual needs to achieve the optimal technical effect. The materials and methods for making the balloon assembly are not particularly limited and may be selected by one skilled in the art according to actual needs.
Another aspect of the present application provides a medical device comprising a balloon assembly according to any of the other embodiments described herein. In particular, another aspect of the present application provides a medical device for percutaneous interatrial ostomy intervention comprising a balloon assembly according to any of the other embodiments described herein.
In the present application, the material and method for producing the balloon assembly are not particularly limited as long as specific operational requirements can be satisfied.
The balloon and balloon catheter may be made from polyamide (e.g., nylon 66, nylon 12, etc.), polyether amide block copolymers. The method of preparing the balloon catheter may employ various methods known in the art. The balloon may be formed by blow molding. A marker material, typically a platinum iridium alloy, is disposed at the catheter in the balloon. The balloon and the catheter can be bonded together by hot melting, or can be bonded by using a suitable adhesive.
The utility model discloses still include following content:
Embodiment 3 the balloon assembly for administration according to embodiment 1, wherein the balloon catheter has a guide wire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel communicates with the inside of the balloon.
Embodiment 5 the balloon assembly for administration according to embodiment 1, wherein the concave arc-like profile is formed at a longitudinal front portion and/or a longitudinal rear portion of the balloon, and the concave arc-like profile starts from a position radially close to a balloon catheter to end at a radially middle portion of the balloon.
Embodiment 6 the balloon assembly for administration according to embodiment 1, wherein a longitudinal dimension of the balloon is 2/3 or less (1/2 or less) of a radial dimension thereof, such that when the balloon is folded, a region having the concave arc-like profile is mostly folded into the interior.
Embodiment 7 the balloon assembly for administration according to embodiment 1, wherein the pharmaceutical composition comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.
Embodiment 8 the balloon assembly for administration according to any one of embodiments 1 to 7, wherein the balloon assembly comprises two balloons, the concave arc-shaped profile of one balloon is formed at a longitudinal front portion of the balloon, and the concave arc-shaped profile of the other balloon is formed at a longitudinal rear portion of the balloon.
Embodiment 9, the balloon assembly for administration of any of embodiments 1-7, wherein the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.
Embodiment 10, a medical device, in particular for percutaneous interatrial ostomy intervention, comprising a balloon assembly according to any of embodiments 1-9.
The ranges described above may be used alone or in combination. The present application can be more easily understood by the following examples.
Examples
Example 1 [ one balloon, concave arc located at the longitudinal front of the balloon, pharmaceutical composition paclitaxel and iopromide, one plane treated ]
As shown in fig. 1, the balloon assembly for administration disclosed in the present application includes a balloon catheter 1 and a balloon 2, and the balloon 2 is disposed at a balloon catheter front portion 12. The diameter of the balloon catheter 1 is 1.8F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front portion 22, a longitudinal middle portion 23 and a longitudinal rear portion 24.
Fig. 2 shows the configuration of the balloon assembly when fully expanded, the balloon 2 having a longitudinal dimension of 10mm and a radial dimension of 15mm, and a concave arc-like profile 25 in a longitudinal cut at the longitudinal front portion 22. The concave arc profile 25 begins at a point 251 radially adjacent the balloon catheter and ends at a radially middle portion 252 of the balloon. The radial distance from the center line of the balloon catheter 1 to the balloon catheter approach 251 is 2mm, and the radial distance from the center line of the balloon catheter 1 to the radial middle 252 is 3.75mm [ here, the radial dimension is 15mm, and the balloon radius is 7.5mm ]. The longitudinal distance from the balloon catheter close position 251 to the front end of the balloon catheter is 20mm, and the longitudinal distance from the balloon catheter close position 251 to the front end of the balloon is 10 mm.
As shown in fig. 5, when folded, the balloon 2 is evacuated while being sheathed with the sheath tube 3 having an inner diameter of 5mm from the back side of the region of the concave arc-like profile 25, so that the region of the concave arc-like profile 25 can be embedded in the folded balloon 2 and most of the region of the concave arc-like profile 25 is folded inside.
As shown in fig. 7, a pharmaceutical composition 4 is disposed on the surface of the region of the concave arc-shaped contour 25, and the pharmaceutical composition 4 is paclitaxel and iopromide. The pharmaceutical composition forms a layer 4 of the pharmaceutical composition having a thickness of about 50 microns. In treatment, a guidewire is first placed through the atrial septum and then a fistula of appropriate size is created in the septum. Then, the balloon assembly for drug administration is set on the stoma along a guide wire, after the balloon catheter front portion 12 is pushed to the distal end to reach a target area by using the PTCA technology, a pressurizing liquid is injected into the balloon 2 through the pressurizing liquid channel 14, the balloon 2 is sufficiently expanded under the hydraulic pressure, the pressure in the balloon 2 is maintained, the surface of the area of the concave arc-shaped profile 25 is sufficiently contacted with one surface of the interatrial septum of the stoma to be treated, the drug is rapidly released to the contacted area, after a predetermined expansion time, the pressurizing liquid is extracted, the balloon 2 is deflated, and the balloon assembly is withdrawn to complete the treatment.
Example 2 [ one balloon, concave arc at the longitudinal back of the balloon, pharmaceutical composition rapamycin and iopamidol, one surface treatment ]
Fig. 3 shows the structure of the balloon assembly in a fully expanded state under another embodiment, which comprises a balloon catheter 1 and a balloon 2, wherein the balloon 2 is arranged at the front part 12 of the balloon catheter. The diameter of the balloon catheter 1 is 1.8F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front portion 22, a longitudinal middle portion 23 and a longitudinal rear portion 24.
As shown in fig. 6, when folded, the balloon 2 is evacuated while being sheathed with the sheath tube 3 having an inner diameter of 5mm from the back side of the region of the concave arc-like profile 25, so that the region of the concave arc-like profile 25 can be embedded in the folded balloon 2 and most of the region of the concave arc-like profile 25 is folded inside. The balloon 2 has a longitudinal dimension of 10mm when fully expanded and a radial dimension of 15mm, and has a concave arc-like profile 25 in its longitudinal section at the longitudinal rear portion 22. The concave arc profile 25 begins at a point 251 radially adjacent the balloon catheter and ends at a radially middle portion 252 of the balloon. The radial distance from the center line of the balloon catheter 1 to the balloon catheter approach 251 is 2mm, and the radial distance from the center line of the balloon catheter 1 to the radial middle 252 is 3.75mm [ here, the radial dimension is 15mm, and the balloon radius is 7.5mm ].
A pharmaceutical composition 4 is provided on the surface of the area of said concave arc-shaped profile 25. The pharmaceutical composition 4 is rapamycin and iopamidol. The pharmaceutical composition forms a layer 4 of the pharmaceutical composition having a thickness of about 50 microns. In treatment, a guidewire is first placed through the atrial septum and a fistula of appropriate size is created in the atrial septum. Then, the balloon assembly for drug administration is set on the stoma along a guide wire, the balloon catheter front portion 12 is pushed to the distal end by PTCA technology and reaches the target area through the stoma, a pressurizing liquid is injected into the balloon 2 through a pressurizing liquid passage 14, the balloon 2 is fully expanded under the action of hydraulic pressure, the pressure in the balloon 2 is maintained, the area surface of the concave arc-shaped profile 25 is fully contacted with one surface of the stoma to be treated and rapidly releases the drug to the target area, after a predetermined expansion time, the pressurizing liquid is extracted, the balloon 2 is deflated and the balloon assembly is withdrawn to complete the treatment.
Example 3 [ example 1 and example 2 combination, concave arc shape located in the front and back of the balloon longitudinally, respectively, pharmaceutical composition paclitaxel, rapamycin and iopamidol, two faces processed in sequence ]
The balloon component in example 3 of the present application is a combination of the two balloon components disclosed in examples 1 and 2, wherein the first balloon component adopts the balloon with the longitudinal rear portion 22 having the concave arc profile 25 (i.e., the component of example 2), and the second balloon component adopts the balloon with the longitudinal front portion 22 having the concave arc profile 25 (i.e., the component of example 1). A medicine composition layer 4 is arranged on the surface of the area of the concave arc-shaped contour 25, and the medicine composition layer 4 is paclitaxel, rapamycin and iopamidol.
In the treatment, the front part 12 of the balloon catheter of the first balloon component is pushed to the far end and passes through the fistula to reach the target area in the same way as in the embodiment 2, so that the surface of the area of the concave arc-shaped profile 25 is fully contacted with one side of the interatrial septum at the fistula to be treated, and the first balloon component is withdrawn after the treatment is completed. Then, the front part 12 of the balloon catheter of the second balloon component is pushed to the far end to reach a target area which does not penetrate through the fistula opening in the same way as in the embodiment 1, so that the area surface of the concave arc-shaped profile 25 is fully contacted with the other surface of the atrial septum at the fistula opening to be treated, and the second balloon component is withdrawn after treatment is completed, thereby completing the sequential treatment of two surfaces of the atrial septum at the fistula opening. It should be noted that the stoma itself can be provided with a medication at each treatment.
Example 4 [ a balloon with a concave arc in the longitudinal middle of the balloon, pharmaceutical compositions paclitaxel, rapamycin, iopromide, iopamidol, with simultaneous treatment of both faces ]
Fig. 4 shows a fully expanded structure of the balloon assembly for administering a balloon according to embodiment 4 of the present application, including a balloon catheter 1 and a balloon 2, the balloon 2 being disposed at a front portion 12 of the balloon catheter. The diameter of the balloon catheter 1 is 2.0F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front portion 22, a longitudinal middle portion 23 and a longitudinal rear portion 24.
The balloon 2 has, in its longitudinal section at the longitudinal middle 22, a concave arc profile 25 symmetrical on the radial axis, the concave arc profile 25 starting from a point 251 radially close to the balloon catheter and ending at a radial middle 252 of the balloon. The radial distance from the center line of the balloon catheter 1 at the position 251 close to the balloon catheter is 2mm, and the radial distance from the center line of the balloon catheter 1 to the radial middle part 252 is 6.25.
During folding, two sleeves with an inner diameter of 5mm are respectively sleeved from two ends of the back side of the area of the concave arc-shaped profile 25, and filling fluid (gas or liquid) in the balloon 2 is evacuated, so that the area of the concave arc-shaped profile 25 can be embedded in the folded balloon 2, and most of the area of the concave arc-shaped profile 25 is folded in.
The surface of the area of the concave arc-shaped contour 25 is provided with a pharmaceutical composition 4, and the pharmaceutical composition 4 is paclitaxel, rapamycin, iopromide and iopamidol. In treatment, the front part 12 of the balloon catheter is pushed to a far-end target area by utilizing a PTCA technology, the longitudinal middle part 22 is positioned at a fistula, then pressurizing liquid is injected into the balloon 2 through a pressurizing liquid channel 14, the balloon 2 is fully expanded under the action of hydraulic pressure, the pressure in the balloon 2 is kept, the area surfaces of the symmetrical concave arc-shaped profiles 25 are simultaneously and fully contacted with two sides of the fistula to be treated, medicine is rapidly released to the target area, after a preset expansion time is reached, the pressurizing liquid is extracted, the balloon 2 is deflated, the balloon assembly is withdrawn, and therefore simultaneous treatment on two sides of the fistula is completed.
The above description is intended to be exemplary of the present disclosure, and not to limit the scope of the present disclosure, which is defined by the claims appended hereto.
Claims (12)
1. A balloon assembly for administration, comprising: the balloon catheter comprises a balloon catheter (1) and a balloon (2) arranged on the catheter, wherein the longitudinal section of the balloon (2) has a concave arc-shaped profile (25) when the balloon is fully expanded, and the radial dimension of the balloon is 10 mm-25 mm.
2. A balloon assembly for the administration of drugs according to claim 1, characterized in that the concave arc-like profile (25) is formed in at least one of a longitudinal front portion (22), a longitudinal rear portion (24) and a longitudinal middle portion (23) of the balloon (2).
3. A balloon assembly for administration according to claim 1, characterized in that the balloon catheter (1) has a guide-wire through hole (13) and a pressurizing liquid channel (14), wherein the pressurizing liquid channel (14) communicates with the interior of the balloon (2).
4. A balloon assembly for administration according to claim 1, wherein the balloon (2) is arranged in front of the balloon catheter (1), the balloon front end (21) being at a distance of about 5 to 20mm from the balloon catheter front end (11).
5. A balloon assembly for the administration of drugs according to claim 1, characterized in that the concave arc-like profile (25) is formed in the longitudinal front part (22) and/or in the longitudinal rear part (24) of the balloon (2), the concave arc-like profile (25) starting from a radially proximal balloon catheter (251) and ending in a radially central part (252) of the balloon.
6. A balloon assembly for administration according to claim 1, wherein the longitudinal dimension of the balloon (2) is 2/3 or less of its radial dimension.
7. A balloon assembly for administration according to claim 1, wherein the longitudinal dimension of the balloon (2) is 1/2 or less of its radial dimension.
8. The balloon assembly for administration according to claim 1, wherein a drug composition layer (4) is provided on the surface of the region having the concave arc-shaped contour (25), the drug composition layer (4) has a thickness of 1 micron or more and 100 microns or less, and the drug composition layer (4) contains at least one of paclitaxel and rapamycin, and optionally a drug carrier.
9. The assembly according to any one of claims 1 to 8, characterized in that it comprises two balloons (2), the concave arc-like profile (25) of one balloon (2) being formed at a longitudinal front portion (22) of the balloon (2) and the concave arc-like profile (25) of the other balloon (2) being formed at a longitudinal rear portion (24) of the balloon (2).
10. The balloon assembly for administration according to any of claims 1-8, wherein the balloon (2) is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.
11. A medical device comprising a balloon assembly according to any one of claims 1-10.
12. The medical device according to claim 11, which is a medical device for percutaneous interatrial ostomy interventions.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922049775.9U CN211434679U (en) | 2019-11-25 | 2019-11-25 | Medicine-feeding balloon assembly and medical instrument comprising same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922049775.9U CN211434679U (en) | 2019-11-25 | 2019-11-25 | Medicine-feeding balloon assembly and medical instrument comprising same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN211434679U true CN211434679U (en) | 2020-09-08 |
Family
ID=72310282
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201922049775.9U Active CN211434679U (en) | 2019-11-25 | 2019-11-25 | Medicine-feeding balloon assembly and medical instrument comprising same |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN211434679U (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021103650A1 (en) * | 2019-11-25 | 2021-06-03 | 丁海雁 | Balloon assembly and medical device comprising same |
-
2019
- 2019-11-25 CN CN201922049775.9U patent/CN211434679U/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021103650A1 (en) * | 2019-11-25 | 2021-06-03 | 丁海雁 | Balloon assembly and medical device comprising same |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6692466B1 (en) | Drug delivery catheter with retractable needle | |
| US6706013B1 (en) | Variable length drug delivery catheter | |
| US7621895B2 (en) | Needle array devices and methods | |
| US6547767B1 (en) | Syringe assembly for a catheter | |
| EP1307257B1 (en) | Tortuouse path injection device and method | |
| US6494862B1 (en) | Substance delivery apparatus and a method of delivering a therapeutic substance to an anatomical passageway | |
| WO2019218711A1 (en) | Cutting balloon and balloon catheter | |
| US5893839A (en) | Timed-release localized drug delivery by percutaneous administration | |
| US20080125709A1 (en) | Needle catheter | |
| JP2004538036A (en) | Drug delivery catheter with high compliant balloon with injection hole | |
| JP2006511270A (en) | Mechanical device and method for treatment site extension and drug delivery | |
| CN104857616A (en) | Drug-loading balloon capable of releasing drugs quickly | |
| CN113018660A (en) | Microneedle balloon for interventional drug delivery | |
| CN114082085A (en) | Pre-expanding type double-layer drug perfusion balloon dilatation catheter | |
| CN211434679U (en) | Medicine-feeding balloon assembly and medical instrument comprising same | |
| CN113398444A (en) | Shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis | |
| CN108355230A (en) | More seal wire medicine balloon dilating catheters and its application method | |
| CN112827055B (en) | Medicine-feeding balloon assembly and medical instrument comprising same | |
| CN217661082U (en) | Cutting sacculus pipe of medicine carrying | |
| CN213031623U (en) | Balloon component | |
| CN113769248B (en) | End medicine coating balloon component and medical instrument comprising same | |
| CN214050144U (en) | End medicine coating balloon component and medical instrument comprising same | |
| WO2021103650A1 (en) | Balloon assembly and medical device comprising same | |
| CN218607684U (en) | Non-through micro catheter for local drug delivery and medical instrument comprising same | |
| US11786707B2 (en) | Inflatable balloon over catheter with bypass passageway |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20220705 Address after: 518052 1419, building 1, Shuimu Yifang building, No. 286, Nanguang Road, dawangshan community, Nantou street, Nanshan District, Shenzhen City, Guangdong Province Patentee after: Qiwei medical technology (Shenzhen) Co.,Ltd. Address before: Room 237-238, gate 1, 2 / F, Chegongzhuang Zhongli, Xicheng District, Beijing 100044 Patentee before: Ding Haiyan |
|
| TR01 | Transfer of patent right |