CN118119414A - Balloon catheter - Google Patents
Balloon catheter Download PDFInfo
- Publication number
- CN118119414A CN118119414A CN202280069032.XA CN202280069032A CN118119414A CN 118119414 A CN118119414 A CN 118119414A CN 202280069032 A CN202280069032 A CN 202280069032A CN 118119414 A CN118119414 A CN 118119414A
- Authority
- CN
- China
- Prior art keywords
- balloon
- balloon catheter
- expandable structure
- struts
- catheter
- 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.)
- Pending
Links
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Classifications
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
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- 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
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- 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
- A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
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Abstract
A balloon catheter and method of use thereof are provided. The balloon catheter may include an expandable structure mounted on the composition-coated balloon. The expandable structure includes a plurality of axial struts intersecting the plurality of radially expandable rings for constraining the balloon such that the isolated balloon region can protrude through the opening in the expandable structure when the balloon is inflated. The balloon catheter may be configured to maximize scraping of the composition from the balloon surface during balloon inflation by the struts of the expandable structure.
Description
Incorporation by reference of any priority application
The present application is a continuation-in-part application of U.S. application Ser. No. 17/049,827, filed on 22. 10/2020, which U.S. application Ser. No. 17/049,827 is a national phase application of PCT/US2019/028481 filed on 22. 4/2019, which claims priority from U.S. application Ser. No. 62/662,160 filed on 24/2018, which is incorporated herein by reference in its entirety.
Any and all applications filed with the present application in the application data sheet that determine foreign or domestic priority claims are hereby incorporated by reference in accordance with 37c.f.r. ≡1.57.
Technical Field
The present application relates to drug-coated balloons and methods of use and manufacture thereof.
Background
Vascular stenosis is a common disease with variable morbidity, mainly affecting men and women over 50 years old. Vascular stenosis is characterized by narrowing of the lumen (typically an artery) of a blood vessel due to deposition of plaque material (typically fat and calcium) within the lumen.
Percutaneous Transluminal Angioplasty (PTA) is a procedure in which a flexible thin tube called a catheter is threaded through an artery and directed to the site of a vascular stenosis. When the tube reaches the stenosed artery, the small balloon at the end of the tube is inflated such that pressure from the inflated balloon forces plaque material against the arterial wall to open the vessel and improve blood flow.
Damage to the vessel wall due to balloon inflation may result in restenosis of the vessel in a process known as restenosis.
Drug Coated Balloon (DCB) PTA is similar in procedure to common balloon angioplasty, wherein the addition of antiproliferative drugs delivered from the balloon helps prevent restenosis.
Disclosure of Invention
The drugs (e.g., paclitaxel and sirolimus) in the DCB may be applied to the balloon outer surface along with the carrier or matrix prior to balloon folding (folded) or after folding using techniques such as infusion or deposition. In order to provide predictable doses to the treatment area, care should be taken to evenly distribute the drug over the balloon surface that contacts the lesion.
In order to maximize drug delivery to the treatment site independent of anatomy, DCBs should exhibit minimal drug loss during delivery and maximum release of drug at the treatment site.
Conventional DCBs are susceptible to loss of substantial drug coating during introduction to the target site (delivery) and often expand unevenly, while causing trauma and dissection to the vessel wall, resulting in delivery of only a portion of the drug in an uneven manner. During delivery, the amount of drug lost may be 20% to 85% of the total dose coated on the balloon, while the drug actually delivered to the vessel wall is about 2% to 40% of the total dose. In addition, drug distribution at the target site is often uneven due to drug loss caused by delivery and balloon inflation. Furthermore, since drug delivery is passive, it is directly related to the time required to hold the inflated balloon at the treatment site (residence time) as well as the size of the balloon and the forces exerted thereby on the vessel wall. Thus, DCBs typically require extended residence times of up to 2 minutes.
Thus, there is a need for a drug-coated balloon that is configured to minimize drug loss during delivery and maximize drug delivery at the treatment site, and that would be highly advantageous.
Embodiments of the present application relate to a balloon catheter having an expandable structure mounted on the balloon and configured to constrain inflation of the balloon and facilitate release of its drug coating.
Some aspects of the invention relate to a balloon catheter including an expandable structure mounted on a balloon, the expandable structure including a plurality of axial struts intersecting a plurality of radially expandable rings for constraining the balloon such that isolated balloon regions protrude through openings in the expandable structure when the balloon is inflated. Each of the axial struts has a polygonal (e.g., quadrilateral) cross section and/or rounded corners. The radius of curvature of the rounded corners may be selected from the range of 0.01mm to 0.05 mm.
Some aspects of the invention relate to a balloon catheter including an expandable structure mounted on a balloon, the expandable structure including a plurality of axial struts intersecting a plurality of radially expandable rings for constraining the balloon such that when the balloon is inflated, isolated balloon regions protrude through openings in the structure. The balloon may include a plurality of pleated pleats (folds) that overlap 50% to 80% of the distance between adjacent struts.
Aspects of the invention relate to a balloon coated with a composition and an expandable structure mounted on the balloon. The expandable structure may include a plurality of axial struts intersecting a plurality of radially expandable rings to form a plurality of openings. The balloon catheter is configured to transition between a contracted configuration and an expanded configuration. In the collapsed configuration, the balloon includes a plurality of pleated pleats beneath the expandable structure. In the expanded configuration, the isolated balloon region protrudes through an opening in the expandable structure. The expandable structure is configured to scrape the composition from the balloon as the balloon catheter transitions from the contracted configuration to the expanded configuration.
In any of the balloon catheters described above, the overlap length of each of the plurality of pleated pleats may be less than the distance between adjacent axial struts of the plurality of struts.
In any of the balloon catheters described above, the balloon may be coated with a composition, such as an antiproliferative drug.
In any of the balloon catheters described above, the balloon may include at least two and/or less than or equal to six pleated pleats in the unexpanded state. During inflation of the balloon, the pleated pleats may be deployed to scrape the composition against each strut.
In any of the balloon catheters described above, the distance between adjacent struts may be selected from the range of 0.4mm to 1.1mm when the expandable structure is in a non-expanded state.
In any of the balloon catheters described above, each strut may have a width selected from the range of 70 microns to 90 microns and/or a height selected from the range of 80 microns to 120 microns.
Some aspects of the invention relate to a method of treating a stenosed vessel comprising delivering a balloon catheter as described herein to a stenosed region in a vessel, inflating the balloon of the balloon catheter to thereby form isolated balloon regions protruding through openings in the expandable structure and scraping away the composition, thereby treating the stenosed vessel.
Typical angioplasty balloons are cylindrical in shape when inflated and are constructed of a single material. These symmetrical unitary material structures facilitate coating. However, specialty balloons such as those described herein may be non-cylindrical and have relatively complex geometries and/or include multiple materials. The process described herein provides a coating on these specialty balloons. The coating may include one or more therapeutic layers that are intended to be retained during delivery to the stenotic vasculature and transferred to the vessel wall during inflation. Although certain balloon designs are described herein, the methods may also be applied to other non-cylindrical and/or multi-material balloons, including, but not limited to, cutting balloons, woven balloons, balloon-in-balloon (balloon), scoring balloons (scoring balloon), tapered balloons, orifice balloons (ostial balloon), or low-trauma balloons.
Certain aspects of the invention relate to methods of making any of the drug-coated balloon catheters described herein. The method may include fixedly mounting an expandable structure, such as a nitinol expandable structure, on the balloon. The method may include surface treating the balloon using one or more processes. For example, the balloon may be surface treated by spraying carbon dioxide onto the surface of the balloon and/or applying a plasma to the surface of the balloon. The surface treatment may be performed before or after the step of mounting the expandable structure on the balloon. The method may further comprise coating the balloon and/or the expandable structure with one or more layers of the therapeutic composition. The composition may comprise at least one active pharmaceutical ingredient and at least one excipient. The balloon may be inflated with an expandable structure mounted on the balloon prior to coating the balloon. The balloon may be fully inflated to the pressure indicated thereby. The inflated balloon may form isolated balloon regions protruding through openings in the expandable structure such that a coating may be applied to the isolated balloon regions. After coating, the balloon may be deflated (deflated) to form a plurality of pleated pleats beneath the expandable structure.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although methods and materials similar or equivalent to those described herein can be used in practice or testing, suitable methods and materials are described below. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
Drawings
The balloon catheter is described herein by way of example only with reference to the accompanying drawings. Referring now in specific detail to the drawings, it is emphasized that the details shown are exemplary and for illustrative purposes only and are presented for the purpose of providing a description of the principles and concepts of the disclosure that are believed to be the most useful and readily understood. In this regard, no attempt is made to show structural details of the embodiments in more detail than is necessary for a fundamental understanding of the embodiments, the description taken with the drawings making apparent to those skilled in the art how the several forms of the embodiments may be embodied in practice.
Fig. 1A-1D illustrate the balloon catheter in various inflated states.
Fig. 2A-2B illustrate several strut profiles suitable for use in the expandable structure of a balloon catheter.
Fig. 3A-3E illustrate deployment of the balloon during inflation.
Fig. 4A to 4D show that the strut distance overlaps the folds in a 3-fold balloon.
Fig. 5A-5B show the strut distance overlapping the folds in a 6-fold balloon.
Fig. 6 shows a flow chart of a coating process.
Detailed Description
The present invention relates to a drug-coated balloon that can be used to effectively treat vascular stenosis. In particular, the drug-coated balloon may be used to open an occluded blood vessel and deliver an antiproliferative drug to a treatment site in an efficient and effective manner.
The principles and operation of the present disclosure may be better understood with reference to the drawings and the accompanying description.
It is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments or of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Drug Coated Balloons (DCBs) were developed to treat restenosis after angioplasty. While such balloons are effective in reducing the incidence and severity of restenosis, current designs still suffer from several limitations, including drug loss during delivery and incomplete drug transfer to the arterial wall. The balloon catheter described herein minimizes the above limitations.
Balloon catheters include a balloon having an expandable structure [ also referred to herein as an "expandable Constraining Structure (CS)" ] mounted around the balloon and fixedly attached to one or both ends of the catheter (see, e.g., U.S. publication No. 20140066960, which is incorporated herein by reference in its entirety).
In the unexpanded state, the balloon is folded (e.g., two to six folded pleats) with the expandable structure collapsed over the folded balloon.
In the deployed (expanded) state, the final diameter of the expandable structure of the balloon catheter of the present invention is less than the final diameter of the fully inflated balloon. Although struts (struts) and rings of the expandable structure limit the balloon diameter at the points of contact (forming depressions in the balloon surface), there are no openings between struts and rings, so isolated balloon regions protrude from these openings in the expandable structure when the balloon is fully inflated. This unique configuration protects the vessel wall from balloon deployment and uneven inflation while also being able to apply localized forces to discrete plaque areas.
As shown in fig. 1A-1D, a balloon catheter is provided having an expandable structure mounted on a balloon. The balloon catheter may be configured for use in any biological conduit (e.g., urinary tract, passageway, gastrointestinal tract, etc.) where release of a composition for treatment or diagnosis is desired. One particular use of the balloon catheter of the present invention is for angioplasty (e.g., coronary artery, peripheral, nerve, etc.) in a human subject.
The balloon is coated with one or more layers of a composition, which may include, for example, a suitable solvent or solvent mixture, a carrier (e.g., an adhesive), an excipient, and one or more active pharmaceutical ingredients having anti-inflammatory, cytostatic, cytotoxic, antiproliferative, antimicrotubular, antiangiogenic, antirestenotic (antirestenotic), bactericidal, antineoplastic, antimigration (ANTIMIGRATIVE), thrombogenic, and/or anticoagulant activity. The active ingredient may be in particulate form (e.g., nanoparticles) or provided in the coating in free form.
The solvents used are typically volatile or semi-volatile, allowing for distribution over the expandable surface of the catheter assembly. The solvent combination is intended to promote deposition on the spatial surfaces and deposition in the correct form for passive absorption during expansion. Alternatively, a solvent system containing the drug may be applied so as to be spatially distributed, and a second solvent system applied to obtain the correct form. Examples of the solvent used include a mixture of acetone, tetrahydrofuran, monohydric alcohol (e.g., methanol, ethanol, isopropanol), and water. Examples of active pharmaceutical ingredients include one or more of the following: taxanes (e.g., paclitaxel, docetaxel, taxol (protaxel)), mTor inhibitors (e.g., sirolimus, everolimus, zotarolimus, biolimus), cilostazol, and statins. The final concentration of the active pharmaceutical ingredient is between 0.5 μg/mm 2 and 25 μg/mm 2, for example between 1 μg/mm 2-10μg/mm2.
Examples of excipients that may be included are urea, shellac, citrate, polysorbate/sorbitol, propyl gallate, nordihydroguaiaretic acid, resveratrol and butylated hydroxytoluene. The loading of the transport enhancer is 3% -100% of the weight of the drug. The polymer may act as a carrier (e.g., an adhesive) that may have hydrophilic, hydrophobic, or amphiphilic properties. These may be durable or biodegradable molecules. Some carriers include poly (ethylene glycol), poly (vinyl alcohol), hydroxyethyl cellulose, methyl cellulose, dextran, and poly (vinyl pyrrolidone).
A specific example of a coating is a solvent mixture of acetone, ethanol and water containing paclitaxel and propyl gallate in a weight ratio of 2:1. A specific volume of solution was applied to the expandable portion of the balloon catheter to achieve a paclitaxel dose density of 3 μg/mm 2. The coating is formed after the solvent is dried.
The expandable structure includes a plurality of loops intersecting the plurality of struts to form a cage-like structure that captures the balloon. By including linearization regions (such as zig-zag or s-wave regions) within the ring/struts, the ring and struts can be expanded (respectively) to final diameters and lengths. The expandable structure may be fixedly attached to the catheter shaft at only one end, while the other end is mounted on the shaft and slidable relative to the shaft. Such a configuration allows the expandable structure to shorten during inflation to accommodate radial expansion. In other constructions, the expandable structure may be fixedly attached to the catheter shaft on opposite sides of the balloon.
The contours of the struts (and optionally the ring) are specifically configured to facilitate scraping/wiping of the drug from the balloon surface as the balloon is inflated and deployed. The scraping/wiping may release the drug from the balloon surface or may redistribute (concentrate) the drug along areas on the balloon surface.
As the pleated balloon expands, the pleats shorten and the balloon surface moves in the circumferential direction (in a balloon folded using concentric techniques). Since the balloon catheter of the present invention includes struts and rings mounted on and in contact with the balloon, the balloon surface moves against the struts (inner surface and edges of the struts) as the balloon is inflated and deployed.
Thus, any coating on the balloon surface is effectively scraped (wiped) by the struts (and optionally by the rings) as the balloon is inflated and deployed.
Thus, the balloon catheter of the present invention has the advantage that the expandable structure protects the balloon coating from loss during delivery and acts as a scraping tool to facilitate release of the drug coating at the treatment site.
Two opposite requirements are considered when designing the profile of the struts of the balloon catheter of the present invention. The scraping effect may be enhanced by the post profile exhibiting sharp edges to the moving balloon surface. Such a rim profile can effectively lift and separate the coating from the balloon surface. However, sharp edges can also damage the balloon surface and cause the balloon to rupture. To maximize scraping and protect the balloon from rupture during deployment, the strut profile may include four sides (e.g., square, rectangular, trapezoidal) with rounded edges having a radius of curvature of 10 microns to 40 microns. The pillars may have a width selected from the range of 70 micrometers to 90 micrometers and a height selected from the range of 80 micrometers to 120 micrometers, and may be electropolished.
Such dimensions and contours ensure that the struts provide the necessary stability to the expandable structure (to constrain the balloon at high pressure), preventing the balloon surface from being effectively scraped during inflation to present most, if not all, of the coating for delivery while the balloon ruptures during inflation. Since the pillows (hillows) formed after inflation concentrate the radially outward force exerted by the balloon on the vessel wall, the drug distributed on the balloon surface after scraping is delivered by this direct contact.
As mentioned above, current DCBs are limited by drug loss during transport. While coatings that adhere more strongly to the balloon surface can be used to minimize such losses, strongly adherent coatings require longer balloon residence times to effectively deliver the desired dose at the treatment site.
Since the balloon catheter of the present invention employs a scraping mechanism, the tradeoff between drug adhesion and drug release is not a limitation thereof.
As such, the balloon catheter of the present invention may include a coating that adheres strongly to the balloon surface to further minimize drug loss during delivery.
Such coatings may include binders, such as hydrophilic, hydrophobic, or amphiphilic polymers. These may be durable or biodegradable molecules. The binders may be mixed in a layer containing the active pharmaceutical ingredient or they may be used as a base layer, cover layer or more than one layer.
Prior to inflation, the balloon is folded under the expandable structure. The drug coating is disposed on the outer surface of the balloon (and sometimes at least partially structurally) along at least a portion of the working length of the balloon (e.g., the surface between the balloon cones). The balloon cone may or may not have a drug coating.
Standard balloon catheters are typically advanced through the blood vessel from the access site to the treatment site during delivery for 1.0m to 1.5m. The balloon may be folded to a smaller diameter to allow delivery through tight vessel anatomy. For example, a balloon with a nominal inflation diameter of 2mm to 6mm will have a folded diameter of 0.7mm to 1.5mm. However, despite the fold, during delivery, a substantial portion of the outer surface of the balloon and drug coating is exposed to the blood and vessel walls. Contact and friction between the balloon outer surface and the vessel wall is particularly pronounced when passing through tortuous anatomy forcing the balloon against the vasculature. The delivery of the unconstrained folded balloon over the curved or inflection section will open the folds of the balloon, as the folds are unprotected and the portion of the balloon closer to the inner radius of the curve covers a shorter distance than the portion of the balloon closer to the outer radius of the curve. These elements result in substantial exposure and drug loss during delivery. Loss of drug prior to inflation within the lesion results in reduced or unpredictable coverage of the therapy that would otherwise be delivered at the site of occlusion, on the one hand, and undesirable systemic drug and particulate release into the patient, which can have any or deleterious effects such as occlusion of arterioles and toxicity.
Since the balloon catheter of the present invention includes an expandable structure disposed about the balloon, the coating is protected during delivery, thereby minimizing the loss of available dose prior to deployment at the target site. In addition, the expandable structure compresses the balloon and prevents it from expanding as it passes through the blood vessel.
During delivery, the balloon is deflated and folded, and the expandable structure covers about 10% to 50% of the exposed surface of the balloon. When the device is inflated to a nominal pressure (e.g., between 8ATM and 10 ATM), the space between longitudinally adjacent struts increases such that the expandable structure covers about 5% to 20% of the working length surface, allowing the distributed drug released by scraping of the struts to contact and diffuse into the vessel wall.
The distance between two adjacent struts of a nominally inflated balloon divided by the distance between two adjacent struts of a folded balloon has a range of 1.7 to 5.5 for a balloon with a nominal diameter of 2.0mm to 4.0mm using four longitudinal struts and a range of 2.4 to 5.5 for a balloon with 4.5mm to 7mm having six longitudinal struts.
The scraping and release of the drug may be optimized by selecting the ratio of the distance between adjacent struts and/or the fold size (length of fold overlap on balloon surface) (see e.g. fig. 4A, 4B and 5A) to the distance between adjacent struts (see e.g. fig. 4C, 4D and 5B). The pleat size may be 50% to 80% of the distance between adjacent struts. The ratio between the pleat size and the adjacent struts may be between 1:0 and 1:1.5 or between 1:0.75 and 1:1.5.
Scraping along the struts may be less effective scraping if the distance between adjacent struts is greater than the pleat overlap. For a given diameter, a small number of pleats results in longer pleats, and therefore more rotation occurs as the balloon is unwound. It is therefore advantageous to have a small number of pleats to enhance scraping. On the other hand, a small number of pleats may exert a high torsional force on the expandable structure and fracture it, so that an optimal number must be considered (in consideration of the distance between adjacent struts, as it is compared to the pleat length). The number of pleats may be greater than or equal to two and/or less than or equal to six.
For a balloon having a diameter in the range of 2mm to 4mm (inflated), the distance between two adjacent struts may be selected from the range of about 0.4mm to 0.8mm, and if six pleats are used, the overlapping length of the pleats may be about 0.2mm to 0.8mm, and if three pleats are used, the overlapping length of the pleats may be about 0.4mm to 1.6mm. Such a configuration may enhance scraping with the struts (and rings).
In some constructions, the length of the pleat overlap may be greater than the distance between adjacent struts. For example, a balloon having a diameter of 3mm and 3 pleats may have a ratio of pleat overlap to distance between adjacent struts of about 1:0.75.
For a balloon having a diameter ranging from 4.5mm to 7mm, the distance between two adjacent struts may typically be in the range of 0.7mm to 1.1mm, and if six pleats are used, the length of the overlap of pleats may be selected in the range of about 0.8mm to 1.3mm, and if three pleats are used, the length of the overlap of pleats is selected in the range of about 1.4mm to 2.5 mm. For larger balloon diameters, six pleats may be used to counteract excessive torsional forces during operating conditions and durability of the expandable structure.
Balloon catheter configurations in which the length of the fold overlap is equal to or less than the distance between adjacent struts can also be used to optimize drug scraping. For example, the ratio of fold overlap to distance between adjacent struts may be 1:1.5, 1:1, or 1:0.
For example, a balloon having a diameter of 6mm and 6 pleats may have a ratio of pleat overlap to distance between adjacent struts of 1:0.7.
Referring now to the drawings, fig. 1A-3E illustrate an embodiment of the balloon catheter of the present invention, referred to herein as device 10.
The apparatus 10 includes a catheter shaft 12 attached to an inflatable balloon 14. The catheter shaft 12 may be up to 150mm in length and may have an outer diameter of 0.5mm to 1.5mm. The catheter shaft 12 may include a longitudinal guidewire lumen for receiving the guidewire 16 and a conduit for inflating the balloon 14. The balloon 14 may be made of non-compliant, semi-compliant or compliant materials (such as polyethylene, nylon, pebax, or polyurethane, etc.) in various lengths and final (inflated) diameters depending on the intended use. An example of the device 10 may include a balloon having a length of between 10mm and 40mm for coronary applications and a length of between 20mm and 300mm for peripheral applications, and having an inflated diameter of between 1.5mm and 10 mm.
Balloon 14 may be thermally bonded or glued to the catheter shaft using an adhesive and attached to an inflation tube extending along the length of catheter shaft 12.
The apparatus 10 further includes an expandable structure 18 comprised of a plurality of radially expandable rings 20 (e.g., up to 16) and a plurality of axial struts 22 (e.g., 4 or more). The expandable structure 18 may include any number of loops 20 and struts 22 depending on the length and diameter of the balloon 14.
The number of axial struts 22 may increase as the diameter of the balloon 14 increases. For example, the balloon 14 shown in fig. 1A-1D may be 3mm in diameter and 20mm in length. Expandable structure 18 may include ten expandable rings and four axial struts. The number of axial struts may be four for a balloon with a diameter of 2mm to 4mm and six for a balloon with a diameter of 4.5mm to 6 mm. The number of expandable rings 20 is proportional to the balloon length. As the balloon is lengthened, the number of expandable rings 20 increases. For example, a balloon of 3mm diameter and 40mm length may include twenty expandable rings. The number of expandable rings 20 is also proportional to the balloon diameter, but at this point, the number of expandable rings 20 is smaller when the diameter is larger. For example, a balloon having a diameter of 4mm and a length of 20mm may be covered by an expandable structure having 8 expandable rings, and a balloon having a diameter of 4mm and a length of 40mm may be covered by an expandable structure having 16 expandable rings.
Expandable structure 18 can be fabricated using techniques known in the art such as laser cutting a nitinol tube and electropolishing to create smooth surfaces and edge radii.
As shown in fig. 1A, the ring 20 may include undulations (e.g., S-shaped regions) to enable radial expansion of the ring 20. Similarly, struts 22 may also include such undulating regions to enable the struts to elongate during balloon inflation. In both the ring and the struts, this undulating region determines the extent of radial expansion and elongation to accommodate balloon inflation and constrain the balloon.
The ring 20 and struts 22 define openings 24 (one framed for emphasis in fig. 1D) in the expandable structure 18 from which balloon regions 26 protrude after inflation. Fig. 1B-1D illustrate various stages of inflation and illustrate linearization of the loop 20 and strut 22 and formation of the protruding balloon region 26 (pillow, best shown in fig. 1D).
As described above, the distance (D, fig. 1D) between adjacent struts 22 of the expanded expandable structure 18 is selected to maximize scraping of the drug. Such a distance may be greater than or equal to about 0.4mm and/or less than or equal to about 1.1mm, such as about 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, or 1.1mm.
The device 10 also includes a coating 30, which may comprise a composition such as an antiproliferative drug. The coating 30 may cover the balloon surface, or the balloon surface and struts and rings.
As shown in fig. 2A-2B, struts 22 are manufactured with a unique profile (cross section) in order to enhance scraping of the balloon coating without damaging (tearing) the balloon wall. Such a profile is preferably polygonal, such as quadrilateral (e.g., rectangular, square, trapezoidal, etc.). Fig. 2A shows a rectangular profile, while fig. 2B shows a trapezoidal profile (with the base (base) positioned to contact the balloon surface).
Such a profile is preferably 4-sided (e.g., square, rectangular, trapezoidal) with rounded edges having a radius of curvature of at least about 0.01mm and/or less than or equal to about 0.05mm, such as about 0.01mm, 0.02mm, 0.03mm, 0.04mm, or 0.05mm.
Fig. 3A-3E illustrate deployment of balloon 14 during inflation, which results in scraping coating 30 from balloon surface 26.
When packaged for delivery, balloon 14 is configured with pleated pleats 40 (three shown) that overlap (fold against) the balloon surface below expandable structure 18 (see fig. 3A). When the balloon 14 is inflated, the pleated pleats 40 expand and rotate, thus moving against the struts 22. This movement scrapes the coating 30 from the balloon surface 26, thereby releasing the composition at the treatment site. In the case of angioplasty, the release and delivery of one or more active pharmaceutical ingredients (e.g., paclitaxel, sirolimus) to the arterial wall may reduce or prevent restenosis following angioplasty. To maximize scraping, the balloon 14 is folded with a small number of pleats (e.g., three pleats). As the number of pleats decreases, the length of the pleats increases. When the balloon is folded in a small number of pleats, each pleat is relatively long, so when these long pleats expand and deploy, they have a longer tangential stroke against the struts.
Fig. 4A to 5B show the relationship between the distance between the struts 22 and the overlapping length of the pleats 40.
Fig. 4A shows a cross section of the apparatus 10 having a diameter of 3.0mm and folded with six pleats 40, each of which overlap by about 0.5mm.
Fig. 4B shows a cross section of the apparatus 10 having a diameter of 3.0mm and folded with three pleats 40, each having an overlap of about 1.0mm.
Fig. 4C and 4D illustrate the apparatus 10 of fig. 4A and 4B (respectively) and illustrate the distance between the struts 22 being about 0.75mm. The number of pleats 40 has little effect on the outer diameter of the folded balloon, so the distance between struts 22 is the same for three and six pleats. Thus, in this example, the ratio of fold overlap to distance between struts is 1:0.75 for a three-fold balloon, and 0.5:0.75 for a six-fold balloon.
Fig. 5A and 5B show a cross section of the apparatus 10 having a diameter of 6.0mm and folded to form six pleats. These figures show that the fold overlap is about 1.3mm and the distance between struts is about 0.9mm. Thus, in this example, the ratio of the fold overlap to the distance between struts is 1.3:0.90, which is equal to 1:0.70.
As described above, the apparatus 10 of the present invention may be used to deliver a composition to any biological conduit. When used in angioplasty, the device 10 is used as follows.
The device 10 is delivered through a pre-positioned guidewire via an access port in an artery, typically the femoral or radial artery, and is directed to a coronary or peripheral lesion.
During the delivery phase, the drug coating on the balloon surface is protected by the expandable structure from drug loss to blood contact.
The balloon is then inflated at the lesion site to dilate the lesion and deliver the drug to the site. During balloon inflation, the balloon pleats are deployed under the expandable structure, scraping/wiping the drug coating from the balloon surface, and allowing it to press into the vessel wall. The balloon remains inflated for a sufficient time (seconds to minutes) to facilitate drug delivery to the lesion and arterial wall.
The balloon is then deflated and removed, and the expandable structure is pressed against the balloon folds to protect the balloon from any residual drug loss during removal.
Method of coating
A process for coating a distal portion of a balloon catheter to obtain a drug coated balloon is disclosed. The coating may comprise one or more Active Pharmaceutical Ingredients (APIs) and one or more excipients dissolved in one or more solvents (e.g., any of the combinations described herein). The solvents typically used are volatile to reduce or minimize drying time. The processes described herein provide a uniform and repeatable coating on a surface that is non-cylindrical and/or is composed of more than one material, and may be applied to any balloon catheter described herein. The coating process 600 may include one or more stages as shown in fig. 6.
These processes may be performed on the distal portion of the balloon catheter. In some processes, the distal portion of the balloon catheter may include an inflatable member (e.g., a balloon) and at least one additional material or secondary structure (which forms a non-cylindrical surface and/or has a surface of more than one material). The auxiliary structure may be another structure placed, mounted or bonded to the balloon. For example, the auxiliary structure may be a patterned structure similar to a stent having circumferential and/or longitudinal members, such as any of the constraining or expandable structures 18 described above. The auxiliary structure may comprise a filament, string, wire, braid or coiled structure.
The balloon may comprise a thermoplastic polymer or PET, polyester, pebax, polyurethane, and/or silicone. The balloon and auxiliary structure may comprise different materials or the same material or materials. In some embodiments, the additional material or auxiliary structure may include a metallic material, such as stainless steel, cobalt-chromium, titanium, and/or nitinol. In other embodiments, the additional material or auxiliary structure may comprise a polymeric material.
The coating process 600 may include one or more of the following stages. Any one or a combination of these stages may be performed before or after the auxiliary structure or additional material is applied to the balloon.
The coating process 600 may include a surface preparation stage 610. The surface to be coated may include one or more surface treatments allowing for an improved interface to be formed between the coating and the balloon catheter surface in a subsequent step. The treatment may include cleaning the surface, removing the material layer to expose an underlying fresh surface, and/or modifying an existing layer.
Immersing or applying a solvent to the surface of the balloon allows dissolving or rinsing the material on the surface. For example, solid (dry) cleaning is a non-abrasive, residue-free method of ensuring that the surface of the balloon is accessible in the absence of organic or hydrocarbon residues. In one example, carbon dioxide may be sprayed or otherwise applied to the surface of the balloon. Carbon dioxide alters the surface energy and wetting properties of the balloon surface, allowing the coating composition to adhere better to the balloon surface.
The plasma treatment may be used alone or in combination with other surface treatments to expose fresh or activated surfaces prior to coating. Activation allows for an increase in the surface energy of the surface. On nylon, this results in a super hydrophilic state, allowing the solution (e.g., an API-containing formulation) to wet the surface of the distal portion of the balloon catheter during the coating process. This results in a minimization of any meniscus formation at the interface of two or more materials and allows for a more dispersed film on the surface. The plasma treatment may be performed using an inert gas, low pressure plasma. Alternatively, the plasma processing may be performed using an atmospheric plasma system.
The coating process 600 may include a coating application stage 620. The coating application stage 620 may include applying one or more layers, wherein at least one of the layers is applied for the purpose of uniformly and repeatedly distributing a determined amount of API over the working length of the distal portion of the balloon catheter. This may be performed using a variety of methods, including dispensing an aliquot on a surface, dip coating, or spray coating. For example, a single pass aliquoting process may be used to apply the coating in which the distal portion moves past the dispensing source once while the distal portion rotates. In this process the linear movement (speed), linear length (distance), dispensing volume, dispensing speed are controlled. The lumen is placed at or near the distal portion to dispense the pre-formulated coating solution and initiate the coating application process.
In some methods, the balloon may be only partially inflated prior to coating. For example, the balloon may be pressurized within the sheath prior to coating to prevent the balloon from fully opening. The partial inflation may increase the diameter of the balloon by at least about 10% and/or less than or equal to about 50%, such as 10% to 20% or 40% to 50%, as compared to an unexpanded balloon. To inflate the balloon, depending on the size, the balloon may be inflated to a pressure of 10psi to 35psi, such as 10psi to 20psi or 25psi to 35psi or up to 15 psi. Thereafter, the pressure may be reduced to less than or equal to about 5psi or less than or equal to about 2psi. The stopcock valve on the catheter may be closed to maintain pressure within the balloon.
In other methods, the balloon may be fully inflated to expose the entire outer surface of the balloon to the coating. When the expandable structure 18 is mounted on a balloon, the isolated balloon region may protrude from an opening in the expandable structure to be coated. Depending on the size, the balloon may be inflated to a pressure of 10psi to 50psi, such as 10psi to 20psi or 25psi to 35 psi. When fully inflated, the balloon may increase in diameter by at least about 300% to 400%, such as 300% to 325%, 325% to 350%, 350% to 375%, or 375% to 400%, as compared to an unexpanded balloon. The stopcock valve on the catheter may be closed to maintain pressure within the balloon.
The coating process 600 can include a post-coating treatment stage 630. Post-processing of the coating is an ancillary process performed on the coated balloon to establish the final configuration. It is an optional process after coating by which the coated surface is modified to homogenize or convert the surface impact properties. The post-coating treatment stage 630 may include a treatment using a solvent-based system for converting the API to a homogeneous solid state form (e.g., to ensure that all materials on the surface are in a particular state or are polymorphs). Alternatively, it may be used to remove soluble auxiliary components to increase the surface area of the primary molecule, thereby ensuring that it is suitable for physical transfer to the surface of the artery. Post-processing may be performed by immersing in or depositing a solvent to convert or expose the API. Alternatively, this may be done by developing in a solvent vapor chamber. In some methods, the post-coating treatment stage 630 may include water immersion to remove excipients. This also hydrates the API to obtain the desired polymorphic structure.
The coating process 600 may include a packaging stage 640. Packaging is the process of placing equipment into its final configuration prior to its final processing and transportation to the point of use. The balloon may be deflated prior to packaging. When deflated, the balloon may form a fold under the auxiliary structure. The configuration of the pleats may be similar to any of the pleat patterns described herein.
In some embodiments, the balloon catheter may be assembled with a distal portion having a folded balloon and an expandable structure fixedly mounted on the folded balloon. The folded balloon may comprise a polymeric material such as nylon. The expandable structure may comprise different materials, for example metallic materials (such as nitinol).
The distal portion of the balloon catheter may be coated using one or more of the following steps:
In the surface preparation stage 610, the surface of the balloon may be prepared with solid carbon dioxide. A CO 2 compound spray generator may be used. The CO 2 output pressure may be set to at least about 1250psi and/or less than or equal to about 1350psi. The propellant pressure may be set to at least about 50psi. The balloon catheter may be placed within a block mount (block mount) with the distal portion exposed. The nozzles may be positioned at a distance within about one inch and at an angle of about 45 degrees relative to the balloon catheter. After inflation to a pressure of 2psi to 50psi, the distal portion of the balloon catheter may be exposed to a steady stream of CO 2 from the nozzle, allowing the balloon to be partially or fully inflated. For a partially inflated balloon, the pressure may be less than or equal to about 10psi, such as less than or equal to about 5psi or less than or equal to about 2psi. For a fully inflated balloon, the pressure may be at least about 10psi and/or less than or equal to about 50psi, such as about 10psi to about 35psi.
The process may include activating the surface by exposure to a low pressure, inert plasma with the balloon in an inflated state. For example, the argon plasma may be applied at a pressure of less than 1kPa or less than 0.1 kPa. The distal portion of the balloon catheter in the inflated state may be plasma treated such that the surface to be coated is exposed. This can be achieved by inflating the balloon (3-35 psi) with a low pressure gas (e.g., air). In some cases, a slightly higher pressure may be required to initially inflate the balloon (10-50 psi) and then decrease to the appropriate range. The plasma may be applied for at least 1 minute or at least 5 minutes.
In the coating application stage 620, the process may include depositing a liquid formulation of the coating on the surface of the distal portion using an aliquot. In this case, the distal portion may be rotated at a constant speed (20 rpm) and may also be advanced linearly with respect to the dispensing nozzle (2-10 mm/s) using a single pass. The liquid formulation may be dispensed at a constant rate, for example, at a rate of about 50uL/min to about 1000 uL/min.
In the post-processing stage 630 of the coating, the applied coating may be immersed in a static aqueous solution at 35C for 75 minutes to ensure that the API is in the correct polymorphic form. This results in the removal of 25% -75% of the relatively hydrophilic excipient, with less than 5% loss of the hydrophobic active pharmaceutical ingredient.
After the post-processing stage 630, the balloon may be deflated. Based on the interaction between the expandable structure and the balloon during deflation, the balloon may refold into a folded configuration under the expandable structure.
Terminology
The scope of the disclosure herein also encompasses any and all overlaps, sub-ranges, and combinations thereof. Languages such as "up to", "at least", "greater than", "less than", "between …", and the like include the recited numbers. The numerals following terms such as "about" or "approximately" include the recited numerals and should be interpreted on a case-by-case basis (e.g., as reasonably accurate as possible in the case, such as ±10%). For example, "about 0.04mm" includes "0.04mm".
Conditional language, such as, inter alia, "may," "for example," etc., as used herein is generally intended to convey that some embodiments include but other embodiments do not include certain features, elements, and/or states unless specifically stated otherwise or otherwise understood in the context of the use. Thus, such conditional language is not generally intended to imply that one or more embodiments require features, elements, blocks and/or states in any way or that one or more embodiments must include logic for determining whether such features, elements and/or states are included or are to be performed in any particular embodiment with or without author input or prompting.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
While the application has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present application.
Claims (37)
1. A method of manufacturing a drug-coated balloon catheter, the method comprising:
mounting an expandable structure on a balloon of the balloon catheter;
surface treating the balloon;
Inflating the balloon with the expandable structure mounted on the balloon;
coating the inflated balloon with a composition comprising an active pharmaceutical ingredient and an excipient; and
The balloon is deflated to form a plurality of pleated pleats beneath the expandable structure.
2. The method of claim 1, wherein mounting the expandable structure on the balloon occurs prior to surface treating the balloon.
3. The method of claim 1, wherein surface treating the balloon comprises spraying carbon dioxide on a surface of the balloon.
4. The method of claim 3, further comprising plasma treating a surface of the balloon.
5. The method of claim 4, wherein applying carbon dioxide to the surface of the balloon is performed prior to plasma treating the surface of the balloon.
6. The method of claim 1, wherein inflating the balloon comprises fully inflating the balloon.
7. The method of claim 1, wherein inflating the balloon comprises inflating the balloon until isolated balloon regions protrude through openings in the expandable structure.
8. The method of claim 7, wherein coating the inflated balloon comprises coating the isolated balloon region.
9. The method of claim 1, further comprising coating the expandable structure.
10. A balloon catheter, the balloon catheter comprising:
a balloon coated with the composition; and
An expandable structure mounted on the balloon, the expandable structure including a plurality of axial struts intersecting a plurality of radially expandable rings to form a plurality of openings,
The balloon catheter is configured to transition between a contracted configuration and an expanded configuration,
Wherein, in the contracted configuration, the balloon includes a plurality of pleated pleats beneath the expandable structure,
Wherein in the expanded configuration, isolated balloon regions protrude through the openings in the expandable structure, and
Wherein the expandable structure is configured to scrape the composition from the balloon as the balloon transitions from the contracted configuration to the expanded configuration.
11. The balloon catheter of claim 10, wherein an overlap length of each of the plurality of pleated pleats is less than a distance between adjacent axial struts of the plurality of struts.
12. The balloon catheter of claim 11, wherein an overlap length of each of the plurality of pleated pleats is 50% to 80%, inclusive, of a distance between the adjacent axial struts of the plurality of struts.
13. The balloon catheter of claim 10, wherein each of the plurality of axial struts has a cross-section with rounded corners.
14. The balloon catheter of claim 13, wherein the radius of curvature of the rounded corners is selected from a range between 0.1mm to 0.5mm inclusive.
15. The balloon catheter of claim 10, wherein each of the plurality of axial struts has a quadrilateral cross section.
16. The balloon catheter of claim 10, wherein the composition comprises an antiproliferative drug.
17. The balloon catheter of claim 10, wherein in the contracted configuration, the balloon comprises two to six pleated pleats, including an end value.
18. The balloon catheter of claim 10, wherein a distance between adjacent axial struts of the expandable structure is selected from a range of 0.4mm to 1.1mm inclusive when the balloon catheter is in the contracted configuration.
19. The balloon catheter of claim 10, wherein each axial strut has a width selected from the range of 70 microns to 90 microns inclusive, and a height selected from the range of 80 microns to 120 microns inclusive.
20. A balloon catheter, the balloon catheter comprising:
An expandable structure mounted on the balloon,
The expandable structure includes a plurality of axial struts intersecting a plurality of radially expandable rings for constraining the balloon such that, when the balloon is inflated, isolated balloon regions protrude through openings in the expandable structure,
Wherein each of the axial struts has a quadrilateral cross section and rounded corners.
21. The balloon catheter of claim 20, wherein the balloon is coated with a composition.
22. The balloon catheter of claim 21, wherein the composition comprises an antiproliferative drug.
23. The balloon catheter of claim 20, wherein in an unexpanded state the balloon comprises between 2 and 6 pleated pleats, including an end value.
24. The balloon catheter of claim 23, wherein the pleated pleats are configured to expand during inflation of the balloon and scrape the composition against one or more of the rounded corners of the struts.
25. The balloon catheter of claim 23, wherein an overlap length of each of the pleated pleats is less than a distance between adjacent axial struts of the plurality of struts.
26. The balloon catheter of claim 20, wherein a distance between adjacent struts of the expandable structure is selected from the range of 0.4mm to 1.1mm inclusive when the expandable structure is in a non-expanded state.
27. The balloon catheter of claim 20, wherein each of the struts has a width selected from the range of 70 to 90 microns inclusive, and a height selected from the range of 80 to 120 microns inclusive.
28. The balloon catheter of claim 20, wherein the radius of curvature of the rounded corners is selected from a range between 0.1mm and 0.5mm inclusive.
29. A balloon catheter, the balloon catheter comprising:
An expandable structure mounted on the balloon,
The expandable structure includes a plurality of axial struts intersecting a plurality of radially expandable rings for constraining the balloon such that, when the balloon is inflated, isolated balloon regions protrude through openings in the expandable structure,
Wherein the balloon comprises a plurality of pleated pleats overlapping between 50% and 80% of the distance between adjacent struts, inclusive.
30. The balloon catheter of claim 29, wherein the balloon is coated with a composition.
31. The balloon catheter of claim 30, wherein the composition comprises an antiproliferative drug.
32. The balloon catheter of claim 29, wherein each of the plurality of axial struts has a cross-section with rounded corners.
33. The balloon catheter of claim 32, wherein the radius of curvature of the rounded corners is selected from a range between 0.1mm and 0.5mm inclusive.
34. The balloon catheter of claim 29, wherein each of the plurality of axial struts has a quadrilateral cross section.
35. The balloon catheter of claim 29, wherein in a non-expanded state, the balloon comprises between two and six pleated pleats, including an end value.
36. The balloon catheter of claim 29, wherein a distance between adjacent axial struts of the expandable structure is selected from the range of 0.4mm to 1.1mm inclusive when the balloon catheter is in a non-expanded state.
37. The balloon catheter of claim 29, wherein each axial strut has a width selected from the range of 70 microns to 90 microns inclusive, and a height selected from the range of 80 microns to 120 microns inclusive.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/445,696 | 2021-08-23 | ||
| US17/445,696 US20210402160A1 (en) | 2018-04-24 | 2021-08-23 | Balloon catheter |
| PCT/US2022/075221 WO2023028443A1 (en) | 2021-08-23 | 2022-08-19 | Balloon catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN118119414A true CN118119414A (en) | 2024-05-31 |
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| CN202280069032.XA Pending CN118119414A (en) | 2021-08-23 | 2022-08-19 | Balloon catheter |
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| EP (1) | EP4392088A1 (en) |
| JP (1) | JP2024532310A (en) |
| CN (1) | CN118119414A (en) |
| WO (1) | WO2023028443A1 (en) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9295663B2 (en) * | 2010-07-14 | 2016-03-29 | Abbott Cardiovascular Systems Inc. | Drug coated balloon with in-situ formed drug containing microspheres |
| US9216033B2 (en) | 2012-02-08 | 2015-12-22 | Quattro Vascular Pte Ltd. | System and method for treating biological vessels |
| CN112041018A (en) * | 2018-04-24 | 2020-12-04 | 特里雷米医疗有限责任公司 | Balloon catheter |
| US11672959B2 (en) * | 2019-01-18 | 2023-06-13 | Intersect Ent, Inc. | Expandable member systems and methods for drug delivery |
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2022
- 2022-08-19 JP JP2024512166A patent/JP2024532310A/en active Pending
- 2022-08-19 EP EP22765727.7A patent/EP4392088A1/en active Pending
- 2022-08-19 WO PCT/US2022/075221 patent/WO2023028443A1/en active Application Filing
- 2022-08-19 CN CN202280069032.XA patent/CN118119414A/en active Pending
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| JP2024532310A (en) | 2024-09-05 |
| WO2023028443A1 (en) | 2023-03-02 |
| EP4392088A1 (en) | 2024-07-03 |
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