Balloon catheters and related methods

Abstract

A method for manufacturing a balloon catheter includes preparing a balloon having a helical portion including a radially outer portion and a radially inner portion that at least partially borders the lumen, and forming a cover on at least one of the radially outer portion and the radially inner portion by electrospinning.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to U.S. Provisional Application No. 63 / 454,778, filed on 27 March 2023, and U.S. Provisional Application No. 63 / 511,634, filed on 30 June 2023. [Background technology]

[0002] Balloon catheters have various applications, including the treatment of coronary arteries. Generally, balloon catheters can be inserted into a patient's vascular system and manipulated to a desired position.

[0003] The term "catheter" can refer collectively to a wide range of medical devices inserted into the body to (1) diagnose a medical condition, (2) treat a medical condition, (3) deliver nutrition, or (4) deliver medication. More specifically, the term "catheter" may be used to refer to a tube inserted into a patient's body for the purpose of (a) removing a substance from a certain location within the patient's body and / or (b) delivering a medical and / or nutritional substance to a specific location within the patient's body. Catheters can be used in a variety of locations within a patient's body for a variety of purposes. Catheterization is commonly included in the diagnosis and treatment of a patient's cardiovascular system, excretory system, and other similar systems. [Overview of the project] [Means for solving the problem]

[0004] A method for manufacturing a balloon catheter, according to one example of the present disclosure, includes preparing a balloon having a helical portion including a radially outer portion and a radially inner portion that at least partially borders the lumen, and forming a cover on at least one of the radially outer portion and the radially inner portion by electrospinning.

[0005] In a further example, the method includes forming a cover on both the radially outer and radially inner portions by electrospinning.

[0006] In a further example, the helical portion includes multiple coils with axial space between them, and the cover extends across the axial space.

[0007] In further examples, the method includes coating the cover with a therapeutic agent.

[0008] In a further example, the helical portion includes multiple coils that give rise to radially inward and radially outward portions, the multiple coils having axial space between them, and the cover extends across the axial space.

[0009] In further examples, the method includes coating the cover with a therapeutic agent.

[0010] In further examples, the cover has a thickness of approximately 10 to 100 microns.

[0011] In further examples, the cover includes at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

[0012] A system for generating a lumen, according to an example of the present disclosure, includes a tubular balloon that can operate in a contraction mode and an expansion mode. The exemplary system includes an electrospinning cover that constrains the tubular balloon to a substantially helical shape. The tubular balloon has a first diameter in the contraction mode and a second diameter in the expansion mode, the second diameter being larger than the first diameter.

[0013] In a further example, the tubular balloon provides a radially outer portion and a radially inner portion, the radially inner portion at least partially bordering the lumen, and the cover is formed by electrospinning to at least one of the radially outer portion and the radially inner portion.

[0014] In a further example, the cover is formed by electrospinning into both radially outer and radially inner portions.

[0015] In a further example, a tubular balloon comprises multiple coils that give rise to radially inner and radially outer portions, the coils having axial space between them, and a cover that extends across the axial space.

[0016] In a further example, a tubular balloon comprises multiple coils that give rise to radially inner and radially outer portions, the coils having axial space between them, and a cover that extends across the axial space.

[0017] In further examples, the cover includes at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

[0018] In further examples, the cover is coated with a therapeutic agent.

[0019] In further examples, the cover has a thickness of approximately 10 to 100 microns.

[0020] In further examples, the cover includes at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

[0021] In further examples, the cover is coated with a therapeutic agent.

[0022] In further examples, the cover has a thickness of approximately 10 to 100 microns.

[0023] In a further example, the cover includes at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

[0024] These features and other features can be best understood from the following specification and drawings, which are a brief description below.

Brief Description of the Drawings

[0025] [Figure 1] An exemplary balloon catheter system is shown.

[0026] [Figure 2A] A detailed view of the balloon catheter of the balloon catheter system of FIG. 1 is shown. [Figure 2B] A detailed view of the balloon catheter of the balloon catheter system of FIG. 1 is shown.

[0027] [Figure 2C] A cross-sectional view of a portion of an exemplary tube is shown.

[0028] [Figure 3] A detailed view of the movement mechanism of the balloon catheter system of FIG. 1 is shown.

[0029] [Figure 4] Another exemplary balloon catheter system is shown.

[0030] [Figure 5] An exemplary balloon catheter system of FIG. 4 in which the balloon catheter is in the deflated operation mode is shown.

[0031] [Figure 6] An exemplary balloon catheter system of FIG. 4 in which the balloon catheter is in the inflated operation mode is shown.

[0032] [Figure 7A] An illustrative balloon catheter is shown schematicly. [Figure 7B] An illustrative balloon catheter is shown schematicly. [Figure 7C] An illustrative balloon catheter is shown schematicly. [Figure 7D] An illustrative balloon catheter is shown schematicly.

[0033] [Figure 8A] This shows an exemplary method of angiogenesis. [Figure 8B] This shows an exemplary method of angiogenesis. [Figure 8C] This shows an exemplary method of angiogenesis. [Figure 8D] This shows an exemplary method of angiogenesis. [Modes for carrying out the invention]

[0034] In general, balloon catheters may be sufficiently flexible to be inserted into and manipulated through a patient's vascular system, which may include various curves and angles, particularly continuous, opposing curves known as tortuosic regions. Furthermore, balloon catheters may be sufficiently flexible to be non-traumatic so as not to cause injury during use. If the catheter is too rigid, it may be difficult to use in tortuosic regions and could dissect or perforate an artery during manipulation. However, at the same time, balloon catheters may be sufficiently rigid so as to be pushed into or inserted into the patient. If the catheter is too flexible, it may be difficult to advance through tortuosic regions.

[0035] The system disclosed herein can generate a lumen within a patient's body to facilitate the use of medical devices, such as catheters, in blood vessels. The system can facilitate catheterization by generating an additional “working space” (e.g., a lumen) at a desired location within the patient's body. This additional space can be generated by transitioning from a contracting to an expanding operation mode. The additional space can enable the use of other medical devices by overcoming conventional access problems such as vascular tortuosity or slight stenosis. The system can enable the insertion of a balloon angioplasty catheter or stent catheter through the lumen's passage or tunnel, overcoming access problems and reaching the desired location. In some examples, the generated lumen prevents arterial occlusion during insertion of the system, allowing for longer insertion times compared to conventional balloon catheters.

[0036] Figure 1 schematically shows an exemplary balloon catheter system 8 with variable flexibility. In some examples, the balloon catheter system 8 can be used in balloon angioplasty. Figures 2A and 2B show detailed diagrams of the exemplary balloon catheter system 8. The balloon catheter system 8 includes a balloon catheter 10 having a lumen 12 inside. In some examples, the balloon catheter system 8 may further include other features such as valves for interface with other medical devices, such as inflation systems.

[0037] In some examples, as shown in the figures, the tube 13 is positioned along the balloon catheter 10 and extends along its entire length or substantially its entire length. In the examples in Figures 1 to 2B, the tube 13 is located outside the lumen 12 and on the outer surface of the balloon catheter 10. However, in other examples, the tube 13 may be located inside the lumen 12 along the inner surface of the balloon catheter 10.

[0038] Tube 13 may be connected to the balloon catheter 10 by any suitable means. In some examples, tube 13 may be continuous with or integral to the balloon catheter 10. In some examples, tube 13 has approximately the same flexibility as the balloon catheter 10. In certain examples, tube 13 is made of the same material as the balloon catheter 10. Tube 13 may be hollow and may be configured to receive a support wire 14 (shown in Figure 2B) inside its inner diameter. Tube 13 can protect and guide the support wire 14 and further help prevent the support wire 14 from puncturing or otherwise damaging the patient's vascular system. In some examples, the distal end 13a of tube 13 is closed.

[0039] In one example, tube 13 is a polyimide tube. As shown in Figure 2C, the polyimide tube 13 has an inner diameter d of approximately 0.008 to approximately 0.011 inches. i and an outer diameter d of approximately 0.011 to 0.014 inches. o It may have an inner diameter d. i It may be approximately 0.008 inches, and the outer diameter d o The diameter is approximately 0.011 inches, and the support wire 14 is a support wire with a diameter of 0.007 inches.

[0040] The support wire 14 may be a metal wire, such as a medical-grade stainless steel (SST) wire. In some examples, the support wire 14 may be made from 304 SST or 304L SST. Other examples of support wire 14, such as cable or polymer material, are also possible. In some examples, the support wire 14 may have a diameter of about 0.007 to about 0.010 inches.

[0041] In some examples, the support wire 14 has variable flexibility. For example, the distal end 14a (Figure 2B) of the support wire 14 may have different stiffness than the opposite proximal end 14b (Figure 3). In one example, the distal end 14a may be more flexible than the proximal end 14b. The support wire 14 may be tapered, with flexibility / stiffness varying with respect to the diameter of the taper, or it may include multiple materials / material structures (e.g., braids, cables, or coils) having different stiffnesses.

[0042] In some applications, medical professionals may require a more rigid catheter to allow for correct insertion into the correct position. Alternatively, a more flexible catheter may be needed. By allowing the wire 14 to be moved in and out of the balloon, medical professionals can change the rigidity of the distal end of the catheter. Furthermore, if the wire 14 has variable rigidity, when the wire 14 is fully inserted into the balloon, the balloon may have variable rigidity that can be advantageous for correct insertion of the catheter.

[0043] As will be described in more detail below, the support wire 14 may be selectively positioned within the tube 13. For example, the support wire 14 may be positioned within the tube 13 so that at various points in time it extends over the entire balloon catheter 10 (i.e., the support wire 14 is fully extended), extends along only a portion of the balloon catheter 10 (i.e., the support wire 14 is partially extended), or does not extend anywhere along the balloon catheter 10 (i.e., the support wire 14 is fully retracted). For example, the support wire 14 can be positioned to extend along only the proximal half of the balloon catheter 10. The support wire 14 can selectively increase the stiffness of the balloon catheter 10 only in the region along which the support wire 14 extends. Thus, in some examples, the flexibility / stiffness of the balloon catheter 10 can be selectively adjusted.

[0044] The balloon catheter 10 can take any form. In the example shown in the figure above, the balloon catheter 10 is a spiral balloon that can be inflated to provide a lumen 12. However, other forms are also possible.

[0045] In one example, the balloon catheter system 8 includes a retractor 16 for extending and retracting a support wire 14 relative to the balloon catheter 10, such as a lever or rotary knob (best shown in Figure 3). The retractor 16 may include markings indicating the position of the support wire 14 relative to the balloon catheter 10. For example, an icon 18 for positioning the support wire 14 may be included on the retractor 16 of the balloon catheter, such as on the handle. An arrow 19 on the retractor 16 may point to a position on the icon indicating the position of the support wire 14 relative to the balloon portion of the balloon catheter. In particular, the markings on the icon 18 may correspond to the position of the distal end 14a of the support wire 14 relative to the balloon catheter 10.

[0046] The balloon catheter system 8 may include a guidewire lumen and / or a rapid exchange (Rx) mechanism (not shown). The guidewire lumen and / or Rx mechanism are separate from the tube 13 / support wire 14.

[0047] The balloon catheter system 8 can be used as follows: The healthcare provider can partially or completely advance the support wire 14 into the tube 13 to increase the stiffness of the balloon catheter 10. The balloon catheter 10 can then be inserted into the patient's body and vascular system. During insertion, the healthcare provider can adjust the stiffness of the balloon catheter 10 according to the characteristics of the vascular system, such as tortuous areas, by extending and retracting the support wire 14 as described above. In some examples, the healthcare provider can provide the balloon catheter 10 with different desired stiffnesses by completely retracting the support wire 14 from the balloon catheter system 8 and replacing it with another support wire having a different desired stiffness.

[0048] Figure 4 shows another exemplary balloon catheter system 108. The balloon catheter system 108 may include any of the features of the balloon catheter system 8 described above, and vice versa. In some examples, the balloon catheter system 108 can be used in balloon angioplasty. The balloon catheter system 108 includes a balloon catheter 10 and a nose cone 200. The nose cone 200 includes a conical portion 201 having a pointed tip 202 spaced distally from an introducer 204. The conical portion 201 may generally be a soft or "rubberized" non-traumatic (non-pointed) conical tapered tip that functions as the leading or distal point of the balloon catheter assembly 108, as shown in Figure 4. Thus, the nose cone 200 facilitates the insertion of the balloon catheter assembly 108 to the target position in the patient. The introducer 204 may be a rod extending proximal to the conical portion 201, enabling the positioning of the nose cone 200 relative to the balloon catheter 10. In some examples, the nose cone 200 is attached to the introducer 204 and includes a pull wire 206 extending proximal from the introducer 204. The pull wire 206 is configured to remain accessible to the healthcare provider using the balloon catheter system 108 when the balloon catheter system 108 is inserted into the patient's body, and thus the nose cone 200 can be removed independently of the balloon catheter 10, as will be described in more detail below.

[0049] The nose cone 200 may be configured to be received in the lumen 12 of the balloon catheter 10. When the balloon catheter 10 is in a deflated or shrinking operation mode, it may collapse around a portion of the nose cone 200. In the particular example shown in Figure 5, the nose cone 200 may be positioned such that the collapsed balloon catheter 10 is positioned around the introducer 204.

[0050] The conical portion 201 of the nose cone 200 has a maximum diameter d that is approximately the same size or slightly larger than the diameter d of the balloon catheter 10 in a collapsed or reduced state. b In some examples, the diameter d can be from about 0.040 to about 0.042 inches. In some examples, the introducer 204 includes a collar 208 at its proximal end. The collar 208 has a diameter that is approximately the same size or slightly larger than the diameter d of the balloon catheter 10 in a reduced state, and can have the same diameter as the maximum diameter d of the conical portion 201. Thus, the balloon catheter 10 is captured between the conical portion 201 and the collar 208 when in the reduced operating mode in this example. n The nose cone 200 can be configured to interface with other medical devices used with the balloon catheter. For example, the balloon catheter system 108 can be configured to interface with a coronary guide wire, such as a coronary guide wire having a diameter of 0.014 inches in some examples. In this example, the nose cone 200 includes a lumen having a diameter of 0.016 inches configured to receive the guide wire. n The balloon catheter assembly 108 can be used as follows. The nose cone 200 can be placed within the balloon catheter 10 as shown in FIG. 5. Then, the balloon catheter assembly 108 can be inserted into the patient's vasculature to a desired position while the balloon catheter 10 is in the reduced operating mode. As described above, the nose cone 200 can include a mechanism for holding the balloon catheter 10 in a fixed position on the nose cone 200 during insertion such that the balloon catheter 10 and the nose cone 200 move together. b n n

[0051]

[0052] <00002i0>

[0053] ​​​Once the balloon catheter 10 is in the desired position, the balloon catheter 10 can be moved into expansion mode by inflation or by another method suitable for the balloon catheter 10, as shown in Figure 6. In expansion mode, the lumen 12 of the balloon catheter is the maximum diameter d of the conical portion of the nose cone 200 and the optional collar 208. n It has a larger diameter than the above. For example, the lumen 12 can have a diameter of about 2 mm or 0.078 inches. The nose cone 200 can then be removed from the lumen 12 without disturbing the balloon catheter 10 by pulling, for example, the pull wire 206 described above, when the balloon catheter 10 is in the expansion operation mode.

[0054] Figures 7A–7D schematically show an exemplary balloon catheter 310 that can be used with any balloon catheter system, including the system 8 / 108 described above. The balloon catheter 310 in this example includes a balloon 310a wound to form a helix 312. A cover 314 restrains the balloon 310a to the helix 312. Furthermore, the cover 314 restrains the helix 312 from stretching or contracting to a perceptible extent when the balloon catheter is in use, thereby suppressing abrupt bending or twisting of the balloon 310. The cover 314 can be provided on the inner surface 312a of the helix 312 (e.g., the surface facing the lumen 12), the outer surface 312b of the balloon catheter 10, or both. When the cover 14 is provided on both sides 312a / 312b, it encloses the balloon 310 as best shown in Figure 7D.

[0055] In some examples, the cover 314 may be manufactured by electrospinning. Generally, electrospinning produces fibers, particularly small-diameter fibers with a diameter of several hundred nanometers. These fibers can be used to produce material sheets such as the cover 314. Electrospinning involves an electrohydrodynamic process in which droplets are charged to generate a jet, and then tensile and stretched to produce fibers.

[0056] In some examples, cover 314 may include any material suitable for electrospinning, including polyethylene, polypropylene, polyurethane, nylon, nylon blends, and polyester (such as polyethylene terephthalate (PET or PETE)), which are medical-grade polymers.

[0057] The cover 314 may be compliant, semi-compliant, or rigid. A compliant or semi-compliant cover 314 can stretch along with the balloon 310a as the balloon 310a expands to higher pressures.

[0058] The cover 314 can be hydrophilic or hydrophobic. A balloon catheter 310 having a hydrophilic cover 314 may be particularly beneficial for inserting the balloon catheter 310 or for interfacing the balloon catheter 310 with other medical devices such as (coronary) guidewires or guide catheters. In some examples, medical devices having a hydrophilic surface may be more slippery and easier to insert into the patient.

[0059] The cover 314 may be made from a material having additives such as drugs or drug additives. For example, drug additives may be selected to prevent or reduce neointima-hyperplasia, also known as scar tissue. Thus, a balloon catheter 310 having cover 314 can prevent or reduce the formation of scar tissue and keep the blood vessel or artery open for (blood) flow. Other drug additives are also conceivable. Additives may be used, for example, to treat tumors or cancer.

[0060] In another example, additives may be selected to improve the properties of the balloon catheter 310 / cover 314. For example, the cover may be fabricated with various additives. The cover 314 may contain additives that enable adhesion or bonding to the balloon 310a. In a particular example, the additive may be acrylic that enables bonding. Furthermore, the additives disclosed herein may be used with other balloon catheters, including the disclosed balloon catheter 10 or any other balloon catheter.

[0061] In some examples, the balloon catheter 10 / 310 disclosed herein, or any other balloon catheter, may be made of materials such as PET, Pebax, nylon, polyurethane, or combinations thereof, or any other compliant, non-compliant, or semi-compliant material. In some examples, the balloon catheter 10 / 310, or any other balloon catheter, may have one or more pharmaceutical or therapeutic agents, such as drugs, biologics, or combinations thereof, in combination with a drug delivery matrix composed of a combination of hydrophilic, hydrophobic, or amphiphilic excipients, coated on the outermost surface, or dispersed throughout or in part of the body. The drug delivery matrix may include an immediate-release matrix and a delayed or controlled-release matrix to achieve an effective and targeted delivery profile of the therapeutic agent in the environment in which it is deployed.

[0062] In some examples, the balloon catheter 10 / 310 disclosed herein, or any other balloon catheter, may be positioned to remain in the environment for several seconds, several minutes, several hours, or even longer periods to ensure delivery of the therapeutic agent at an optimal rate in the environment, so that an effective level of the drug in the body can be reached with the smallest possible amount of drug. In one embodiment of such a device, to reduce the risk of particle embolism, a drug such as sirolimus is delivered at a surface drug volume of approximately less than 0–1 microgram / cubic millimeter by manipulating the residence time, and a drug such as paclitaxel is delivered at a surface drug volume of less than 2 micrograms / cubic mm. For balloon catheters that provide a lumen 12 so as not to occlude blood flow when in expansion mode, the positioning time can be longer than that of other types of balloon catheters in some examples. A balloon catheter that does not cause such occlusion may be called a perfusion balloon catheter.

[0063] The cover 314 can have a thickness suitable for restraining the helix as described above. In some examples, the cover 314 can have a thickness of about 10 to about 100 microns (0.010 to 0.100 millimeters). In some examples, the cover 314 may have a thickness of about 15 to about 30 microns.

[0064] The cover 314 can have a porosity suitable for balloon catheter applications. The porosity can be controlled when applying / depositing the cover 314 onto the balloon catheter 310. A cover 314 with high porosity can act as a filter, while a cover 314 with relatively low porosity is thought to not allow fluid flow to pass through. Therefore, a cover 314 with lower porosity may be suitable for procedures aimed at stopping bleeding from an artery, such as treating arterial dissection or perforation, or closing a percutaneous access site to an artery, because the cover 314 does not allow blood flow to pass through the cover 314 itself. For example, TAVR (transcatheter aortic valve replacement) procedures create a large-diameter access site in an artery. Once the TAVR procedure is complete, the access site needs to be closed. If the access site is not closed, bleeding occurs, leading to harmful medical complications. A balloon catheter 310 with a low-porosity cover 314 can be inflated inside the artery to cover the access site and stop bleeding from the access site. The balloon catheter 310 can be kept in place until the artery spontaneously closes the access site and achieves hemostasis. In some cases, this may take approximately 30 to 60 minutes.

[0065] The cover 314 may include one or more sub-components. For example, as shown in Figure 7D, the cover 314 may include a base portion 314a combined with the inner surface 312a of the helix and an outer portion 314b combined with the outer surface 312b of the helix 312. In this example, portions 314a / 314b of the cover 314 can be applied separately and sequentially to the balloon catheter 310. For example, the base portion 314a can be applied to the inner surface 312a of the helix by electrospinning. Then, the outer portion 314b can be applied to the outer surface 312b of the helix by electrospinning. The sub-components 314a / 314b may be applied separately, but in some examples, once applied, the sub-components 314a / 314b can form a continuous or single cover 314.

[0066] The helix 312 can form several adjacent coils C. In some examples, as shown in Figure 7D, the adjacent coils C create an axial space S between them, and the cover 314 extends across the space S. The cover may include a bridge portion 314c that extends axially across the space S. The bridge portion may be formed when applying the base portion 314a, the outer portion 314b, or both.

[0067] In some examples, the cover 314 may be manufactured by different methods. For example, the cover 314 can be manufactured using a dip coating method. In this example, the tubular balloon 310a formed on the helix 312 can be immersed in a source of liquid polymer. The polymer dries to a solid state, forming the cover 314 of the balloon catheter 310. Urethane polymers or other elastomers may be particularly suitable for the cover 14 by dip coating. Alternatively, the cover 314 may be produced using a vapor deposition method. This method forms a conformer coating that constitutes the cover 314 on the balloon 310a. Parylene polymers may be particularly suitable for vapor deposition of the cover 314.

[0068] The systems disclosed herein may be used in any of the methods and procedures disclosed in U.S. Patent No. 11,096,813, the entirety of the disclosure in U.S. Patent No. 11,096,813 is incorporated herein by reference.

[0069] Methods for performing angioplasty can be carried out using any of the systems disclosed herein. Within the scope of this disclosure, fewer steps or additional steps than those described herein may be performed, and the order of the steps described is not limiting to this disclosure. This method may include accessing an artery. In some examples, the artery may be accessed via the transradial or transfemoral artery. This method may include inserting a balloon 10 / 310 into the artery in a deflating motion. The balloon 10 / 310 may be constrained to a substantially helical shape. This method may include positioning the balloon 10 / 310 adjacent to the occlusion of the artery. In some examples, the balloon 10 / 310 may be introduced into or near a region in the artery with plaque. This method may include forming a lumen 12 inside a substantially helical shape by expanding the balloon into an expanding motion that defines the lumen 12 by the helical inner surface. In some examples, this method may include passing a stent directly into the lumen 12 such that there is no intervening structure between the helical inner surface and the stent. This method may include implanting a stent into the occlusion. In some examples, balloon 10 / 310 may be removed before the stent is introduced.

[0070] As shown in Figure 8A, exemplary methods may include artery A having plaque location P. As shown in Figure 8B, a balloon catheter 10 / 310 can be introduced to location P in deflating mode. In some examples, the balloon catheter 10 / 310 is introduced to this location by one of the introduction methods disclosed herein. The balloon is then converted to expansion mode at location P, as shown in Figure 8C. In expansion mode, blood can still flow through the lumen 12. As shown in Figure 8D, one or more pharmaceuticals and / or therapeutic agents can be released from the balloon catheter 10 / 310 at location P, while blood can still flow through the lumen 12. In some examples, a stent (not shown) can be placed at location P. In some examples, the stent can be placed at location P after the balloon 10 / 310 has been removed from location P. In some examples, the balloon 10 / 310 may be placed at a location away from location P and converted to expansion mode, and the stent can pass through the lumen 12 on its way to introduction to location P.

[0071] A medical device according to one or more examples of this disclosure may be said to include a balloon catheter in which a balloon is positioned. The balloon may include obedient, semi-obedient, or non-obedient material forming a lumen. In a deflated state, the balloon can be transported to the point of application. In some examples, the balloon may have one or more pharmaceutical and / or therapeutic agents, such as drugs, biologics, or combinations thereof, in combination with a drug delivery matrix coated on or positioned on the balloon or dispersed in the balloon material. The therapeutic agent can be released at a desired rate in the environment to which it is positioned. In some examples, the positioning rate can be optimized by adjusting the residence time of the balloon in the area to which it is positioned to several seconds, several minutes, several hours, or even longer.

[0072] In some examples, an inflatable balloon is helical in shape containing compliant, semi-compliant, or non-compliant material, which can be coiled around a central axis to form a helix and inflated to create a lumen, and can be transported, for example, to the point of application in a deflated state. In some examples, a helical balloon can release one or more pharmaceuticals or therapeutic agents, such as drugs, biologics, or combinations thereof, at a desired rate in the environment to which it is deployed, and such rate can be optimized by adjusting the residence time of the balloon in the area to which it is deployed to several seconds, several minutes, several hours, or even longer, in combination with a drug delivery matrix coated or arranged on the outer surface of the balloon or dispersed in the helical material.

[0073] One or more examples of the methods of this disclosure can be said to involve passing a deflated balloon catheter along a wire to a location, in some examples, such location being a perforation, lesion, or other target location within a blood vessel, or near thereto. The method may include inflating the balloon to an appropriate pressure to conform to the general shape or size of the blood vessel and achieving contact with the blood vessel at the target location over a specific residence time. In some examples, during the residence time, the encapsulation matrix releases a drug at the target location while allowing blood flow. The method may further include, after treatment, deflating the balloon by withdrawing fluid from the balloon and withdrawing the balloon and catheter from the blood vessel.

[0074] As used herein, the term “about” has its typical meaning in the art, but in certain instances, “about” may mean a deviation of up to 10% of the values ​​described herein.

[0075] While various examples are shown having specific components, the examples in this disclosure are not limited to any particular combination thereof. Some components or features from any embodiment can be used in combination with features or components from any other embodiment.

[0076] The above description should be interpreted as illustrative and not in any way restrictive. Those skilled in the art will understand that several modifications are possible within the scope of this disclosure. For these reasons, the following claims should be considered in order to determine the true scope and content of this disclosure.

Claims

1. A method for manufacturing a balloon catheter, A balloon is prepared that has a helical portion including a radially outer portion and a radially inner portion that at least partially defines the lumen, The cover is formed by electrospinning on at least one of the radially outer portion and the radially inner portion. A method that includes this.

2. The cover is formed by electrospinning on both the radially outer portion and the radially inner portion. The method according to claim 1, including the method described in claim 1.

3. The method according to claim 2, wherein the helical portion includes a plurality of coils having an axial space between them, and the cover extends across the axial space.

4. The cover is coated with a therapeutic agent. The method according to claim 3, including the method described in claim 3.

5. The method according to claim 1, wherein the helical portion includes a plurality of coils that give rise to the radially inner portion and the radially outer portion, the plurality of coils having an axial space between them, and the cover extends across the axial space.

6. The cover is coated with a therapeutic agent. The method according to claim 1, including the method described in claim 1.

7. The method according to claim 1, wherein the cover has a thickness of about 10 to about 100 microns.

8. The method according to claim 1, wherein the cover comprises at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

9. A system for generating a lumen, A tubular balloon that can operate in contraction mode and expansion mode, A cover formed by electrospinning that restrains the tubular balloon in a substantially helical shape, It is equipped with, The tubular balloon has a first diameter in contraction mode and a second diameter in expansion mode, wherein the second diameter is larger than the first diameter.

10. The system according to claim 9, wherein the tubular balloon provides a radially outer portion and a radially inner portion, the radially inner portion at least partially bordering the lumen, and the cover is formed by electrospinning to at least one of the radially outer portion and the radially inner portion.

11. The system according to claim 10, wherein the cover is formed by electrospinning to both the radially outer portion and the radially inner portion.

12. The system according to claim 11, wherein the tubular balloon includes a plurality of coils that give rise to the radially inner portion and the radially outer portion, the plurality of coils having an axial space between them, and the cover extends across the axial space.

13. The system according to claim 10, wherein the tubular balloon includes a plurality of coils that give rise to the radially inner portion and the radially outer portion, the plurality of coils having an axial space between them, and the cover extends across the axial space.

14. The system according to claim 12, wherein the cover comprises at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

15. The system according to claim 14, wherein the cover is coated with a therapeutic agent.

16. The system according to claim 15, wherein the cover has a thickness of about 10 to about 100 microns.

17. The system according to claim 9, wherein the cover comprises at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester.

18. The system according to claim 9, wherein the cover is coated with a therapeutic agent.

19. The system according to claim 9, wherein the cover has a thickness of about 10 to about 100 microns.

20. The system according to claim 19, wherein the cover comprises at least one of polyethylene, polypropylene, polyurethane, nylon, and polyester. Balloon catheters and related methods.

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