Method of forming a balloon

Abstract

Medical devices including balloons and methods of making medical devices including balloons are provided. The medical device includes a tubular element, a balloon, and a barrier between the tubular element and the balloon. The balloon may be inflated when air is pushed into one end of the medical device. The method includes applying a barrier to a tubular element, applying an elastomeric solution onto at least a portion of the barrier and the tubular element to form a coating, and curing the coating to form a balloon.

Description

[0001] This application claims the benefit of U.S. patent application No. 17 / 972,462, filed on October 24, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to medical devices including balloons and methods of forming medical devices including balloons. In particular, the present disclosure relates to tubular medical devices including elastic balloons for use in vivo. Summary of the invention

[0003] The present disclosure relates to a medical device comprising: a tubular element comprising a tubular wall having a distal end and a proximal end, the tubular element comprising an internal lumen and one or more holes through the tubular wall between the distal end and the proximal end; a balloon extending diametrically around the tubular wall, wherein the balloon is bonded to at least a portion of the tubular wall, and wherein at least a portion of the balloon is not bonded to the tubular wall; and a barrier located between the tubular wall and the balloon, the barrier covering the one or more holes and being permeable to air.

[0004] According to an embodiment, one axial end of the tubular element is sealed.The tubular element may comprise more than one hole through the tubular wall.Additionally or alternatively, the tubular wall comprises a polymer, glass or metal.

[0005] According to an embodiment, the balloon comprises an elastomer. The elastomer may comprise silicone, natural rubber, neoprene, nitrile, or a combination thereof. The balloon may be bonded to the tubular wall adjacent to both axial ends of the barrier.

[0006] According to an embodiment, the barrier has a thickness of 1.0 g / cm 3 In one or more embodiments, the barrier comprises polytetrafluoroethylene (PTFE), such as expanded PTFE (ePTFE).

[0007] In another aspect, the present disclosure relates to a method of forming a medical device including a balloon, the method comprising: applying a barrier to at least a portion of a tubular element, the tubular element comprising a tubular wall having a distal end and a proximal end and one or more holes passing through the tubular wall between the distal end and the proximal end, the barrier covering the one or more holes and being permeable to air; applying an elastomeric solution to the outside of the tubular wall to form a coating, the coating covering the barrier and at least a portion of the tubular wall on at least one axial end of the barrier; and curing the coating to form a balloon.

[0008] Applying the elastomer solution may include dipping.According to an embodiment, the barrier comprises ePTFE.Additionally or alternatively, the barrier remains in place after the coating is cured.

[0009] According to an embodiment, the method further comprises cleaning the tubular element. The method may additionally comprise repeatedly applying the elastomeric solution to substantially the same area to form a plurality of coatings. According to an embodiment, the elastomeric solution comprises silicone, natural rubber, chloroprene rubber, nitrile, or a combination thereof. The elastomeric solution may additionally or alternatively comprise one or more organic solvents.

[0010] In another aspect, the present disclosure is directed to a method of using a medical device consistent with the medical devices described herein, the method comprising pushing air through a proximal end of the medical device to penetrate the barrier and inflate the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1A is a partial schematic side view of a medical device according to the present disclosure including a balloon in a deflated configuration.

[0012] Figure 1B According to the implementation plan Figure 1A A partially schematic side view of a medical device comprising a balloon in an inflated configuration.

[0013] Figure 1C According to the implementation plan Figure 1A A partial schematic perspective view of a medical device comprising a balloon in a deflated configuration.

[0014] Figure 1D According to the implementation plan Figure 1A A partial schematic perspective view of a medical device comprising a balloon in an inflated configuration.

[0015] Figure 2A is a partial schematic side view of a medical device according to the present disclosure including a balloon in a deflated configuration.

[0016] Figure 2B According to the implementation plan Figure 2A A partially schematic side view of a medical device comprising a balloon in an inflated configuration.

[0017] Figure 3A is a partial schematic side view of a medical device according to the present disclosure including a balloon in a deflated configuration.

[0018] Figure 3B According to the implementation plan Figure 3AA partially schematic side view of a medical device comprising a balloon in an inflated configuration.

[0019] Figure 4 is manufactured according to an embodiment of the present disclosure Figures 1A to 3B Flowchart of a method of a medical device shown in FIG.

[0020] Figure 5 This is an image of the medical device with a balloon formed in Example 1.

[0021] FIG. 6A to FIG. 6C This is an image of a medical device having a balloon formed in Example 2.

[0022] The drawings are presented primarily for clarity and are not necessarily drawn to scale. In addition, various structures / components may be shown schematically or removed from some or all of the views to better illustrate various aspects of the depicted embodiments, or the inclusion of such structures / components is not necessary for understanding the various exemplary embodiments described herein. However, the lack of illustration / description of such structures / components in a particular figure should not be construed as limiting the scope of the various embodiments in any way.

[0023] definition

[0024] Unless otherwise specified, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of the present disclosure.

[0025] Unless otherwise indicated, the terms "polymer", "polymerized monomer" and "polymeric material" include, but are not limited to, organic homopolymers, copolymers, such as block, graft, random and syndiotactic copolymers, terpolymers, etc., and blends and modifications thereof. In addition, unless otherwise specifically limited, the term "polymer" shall include all possible geometric configurations of the material. These configurations include, but are not limited to, isotactic, syndiotactic and atactic symmetries.

[0026] As used herein, the term "elastomer" is used to refer to a deformable material. An elastomer can typically stretch significantly when pressure or force is applied, and can return to approximately its original state when the pressure or force is released. An elastomer is typically a polymer.

[0027] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural objects unless the text clearly indicates otherwise. It should also be noted that the term "or" is generally used to semantically include "and / or", unless the context clearly dictates otherwise. As used herein, the terms "and / or" and "any combination thereof" and their grammatical equivalents are used interchangeably. These terms may indicate that any combination is specifically intended. For illustrative purposes only, the following phrases "A, B and / or C" or "A, B, C or any combination thereof" may mean "A alone; B alone; C alone; A and B; B and C; A and C; and A, B and C." The term "or" may be used in conjunction or separately, unless the context clearly indicates separate use.

[0028] Numerical ranges expressed by endpoints include all values ​​contained in that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc., or 10 or less includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). When a range of values ​​is "at most," "at most," or "at least" a particular value, that value is included in the range. Ranges listed as a value "or greater" include that particular value. Ranges listed as a value "or less" include that particular value.

[0029] The term "about" is used herein in conjunction with numerical values ​​to include normal variations in measurements as would be expected by those skilled in the art and is understood to have the same meaning as "approximately" and to cover typical margins of error, such as ±5% of the stated value.

[0030] As used herein, "having", "including", "comprising", etc. are used in their open-ended sense and generally mean "including but not limited to". It will be understood that "consisting essentially of", "consisting of", etc. are subsumed under "comprising", etc. As used herein, "consisting essentially of" when referring to a composition, product, method, etc., means that the components of the composition, product, method, etc. are limited to the listed components and any other components that do not materially affect the basic and novel characteristics of the composition, product, method, etc. In addition, the compositions of the present disclosure can be used to implement the methods of the present disclosure.

[0031] The words "preferred" and "preferably" refer to embodiments that may provide certain benefits under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. In addition, the recitation of one or more preferred embodiments does not mean that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0032] Reference in the specification to "some embodiments," "an embodiment," "one embodiment," "these embodiments," "one or more embodiments," or "other embodiments" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least some embodiments of the present disclosure, but not necessarily all embodiments.

[0033] In several places in this application, guidance is provided by way of examples, which examples (including specific aspects thereof) may be used in various combinations and may serve as the subject of the claims. In each case, the enumerated list serves only as a representative group and should not be construed as an exclusive list. It should be understood that the specific examples, materials, amounts, and processes should be interpreted broadly in accordance with the scope and spirit of the invention as set forth herein.

[0034] For any method disclosed herein that includes discrete steps, the steps may be performed in any feasible order. Also, any combination of two or more steps may be performed simultaneously, where appropriate.

[0035] Unless otherwise indicated, all headings are for the convenience of the reader and should not be used to limit the meaning of the text that follows the heading. DETAILED DESCRIPTION

[0036] Balloons can be used in medical devices to provide temporary, reversible pressure or expansion. As an example, catheters including thin-walled balloons are often used during stent placement. There are some technical difficulties in manufacturing medical balloons as components of tubular structures (such as wires or catheters). During the process of using a medical device with a balloon, it is desired that the balloon remain attached to the device and inflate reliably. In order to manufacture a balloon firmly attached to the device, an elastomer solution is usually poured directly onto the device (e.g., a tubular structure). The tubular structure is provided with pores to inflate and contract the balloon. For reliable performance, the pores can be installed in such a way that the pores are not sealed by the balloon during inflation or contraction. It is hoped that the elastomer solution does not seal or block the pores during manufacturing. In the method of the prior art, the pores on the tubular structure are closed before casting, for example, by using a fusible wax material to prevent clogging. Before the device can be used, the closing mechanism must be removed. Alternatively, the balloon may be manufactured separately from the tubular structure and attached to the tubular structure, however this presents problems associated with attachment of the balloon. It would be desirable to provide a method of manufacturing an inflatable balloon directly on a tubular structure using a pore sealing mechanism that does not need to be removed prior to use.

[0037] The present disclosure provides a method for manufacturing a medical device having an inflatable balloon. The present disclosure provides a method for forming a balloon directly on a tubular element by dipping the tubular element in an elastomeric solution. The method includes using a barrier on the tubular element that does not need to be removed before use. This can advantageously streamline the production of the balloon and reduce potential damage to the medical device associated with removing obstructive materials such as wax. The barrier can reduce or prevent pores on the tubular element from being blocked by the elastomeric solution. The barrier can reduce or prevent the elastomeric solution from adhering to the tubular element. The present disclosure further describes a medical device having an inflatable balloon and a barrier located between the tubular element and the inflatable balloon of the medical device.

[0038] In one or more embodiments, the medical device is an implantable medical device. The medical device can be configured to be used as a pacemaker, a neurostimulator, a cochlear implant, a urinary implant or other implantable medical device. In one or more embodiments, the medical device is intended for temporary use. The medical device can be configured to be used during surgery or implantation of a second medical device (such as a stent). In one or more embodiments, the medical device is a catheter. The medical device can be configured for delivery or removal of fluid. In one or more embodiments, the medical device is a pacing wire. The medical device may include one or more electrodes, one or more fixing elements and / or one or more controllers. In one or more embodiments, the medical device is attached to a proximal controller or a proximal connector.

[0039] In one aspect, the present disclosure provides a medical device comprising a balloon. Figures 1A to 1D An example of a medical device 100 according to an embodiment of the present disclosure is shown. The medical device 100 includes a tubular element 110 having a tubular wall 111. The tubular element 110 has a distal end 101 and a proximal end 102. One or more holes 112 extend through the tubular wall 111 between the distal end 101 and the proximal end 102 of the tubular element 110. The medical device 100 also includes a balloon 130 extending diametrically around the tubular wall. Figure 1A and Figure 1C A schematic diagram of a medical device 100 is shown with a balloon 130 in a deflated configuration S1 . Figure 1B and Figure 1D A schematic diagram of a medical device 100 is shown with a balloon 130 in an inflated configuration S2.

[0040] The balloon 130 is bonded to at least a portion of the tubular wall 111, and at least a portion of the balloon 130 is not bonded to the tubular wall 111. Figures 1A to 1DIn the exemplary embodiment shown, the balloon 130 has a proximal portion 132 and a distal portion 134 that are bonded to the tubular wall 111. The balloon 130 has an inflatable middle portion 135 between the bonded proximal portion 132 and distal portion 134. According to an embodiment, the inflatable middle portion 135 is not bonded to the tubular wall 111. Figure 1B As shown, the inflatable middle portion 135 can be a section that expands during inflation. The medical device 100 also includes a barrier 120 located between the tubular wall 111 and the balloon 130. The barrier 120 covers one or more holes 112 passing through the tubular wall 111 and is permeable to air. The inflatable middle portion 135 has an internal volume that is in fluid communication with the internal lumen 114 of the tubular element 110 through the barrier 120 and the one or more holes 112. Therefore, a gas or liquid (e.g., air) pushed into the internal lumen 114 can be used to inflate the balloon 130.

[0041] The tubular element 110 is generally configured to allow the balloon 130 to be positioned in a desired location. The tubular element 110 generally has a distal end 101 and a proximal end 102. An interior lumen 114 of the tubular element extends between both the distal and proximal ends and is defined by a tubular wall. The interior lumen 114 of the tubular element can be empty, or it can hold additional elements, such as a wire. In one or more embodiments, one end of the tubular element is sealed to be airtight. This can allow air to be pushed into the lumen of the tubular element, thereby inflating the balloon. Figures 1A to 1D In the example shown, the distal end 101 is closed with a seal 140. The seal is generally configured to prevent air from flowing through the distal end 101. Any suitable method of sealing the tubular element can be used, such as applying an adhesive, melting, crimping, or applying a physical plug. The proximal end 102 can be connected to a controller or a proximal connector.

[0042] The tubular wall 111 is generally configured as a fluid-tight barrier between the external environment and the interior lumen 114 of the tubular element 110. When the balloon 130 is inflated, the tubular wall 111 generally does not change shape. Therefore, the material of the tubular element 110 is generally harder than the balloon 130. The tubular wall 111 can have any suitable thickness. In one or more embodiments, the tubular element 110 can be flexible to enable implantation in the body and / or navigation in the body.

[0043] The tubular element 110 can have any suitable length. In one or more embodiments, the tubular element 110 can have a length of 1 centimeter (cm) or more, 2 cm or more, 4 cm or more, 6 cm or more, 10 cm or more, 20 cm or more, 30 cm or more, 50 cm or more, 100 cm or more, or 200 cm or more. In one or more embodiments, the tubular wall can have a length of 500 cm or less, 300 cm or less, 100 cm or less, 80 cm or less, 60 cm or less, 40 cm or less, or 20 cm or less.

[0044] The tubular wall 111 can be formed of any material suitable for use in a medical device. In one or more embodiments, the tubular wall 111 can include or be made of a polymer, glass, metal, or a combination thereof. In one or more embodiments where the tubular wall 111 includes a polymer, the polymer can be a thermoplastic material such as polyurethane, polyether block amide, CARBOTHANE, or a combination thereof. TM (a polycarbonate-based thermoplastic polyurethane available from The Lubrizol Corporation of Wickliffe, Ohio), (a thermoplastic polyurethane available from The Lubrizol Corporation), or a combination thereof.

[0045] One or more holes 112 through the tubular wall 111 are generally configured to allow air to enter the balloon 130 from the interior lumen 114 of the tubular element 110. Figure 2A and Figure 2B In one or more embodiments of the examples shown in , there may be a hole 212 extending through the tubular wall 211. Figure 2A and Figure 2B In the example shown, one hole 212 is positioned on the distal end 201 of the tubular element 210. In some other embodiments, the distal end 201 of the tubular element can be covered by a balloon 230 to form a seal. Figure 3A and Figure 3B An example is shown in which the distal end 301 of the tubular element 310 is covered by a balloon 330, making it airtight.

[0046] Including Figures 1A to 1D and FIG. 3A to FIG. 3BIn one or more other embodiments of the examples shown in , there may be more than one hole 112 passing through the tubular wall. In one or more embodiments in which there are multiple holes 112 passing through the tubular wall 111, the holes 112 may be arranged in any suitable manner. It may be desirable to arrange the holes 112 so that they are not blocked by the balloon 130 during contraction. It may be desirable to arrange the holes 112 so that air enters the balloon 130 at multiple locations during inflation. When air enters the balloon 130 at multiple locations, it can promote more dispersed inflation. This can promote uniform wear of the balloon 130 over multiple uses. In one or more embodiments, the holes 112 can be arranged radially along the axial plane of the tubular element 110. In one or more embodiments, the holes 112 can be distributed along a portion of the tubular element 110.

[0047] The barrier 120 is generally configured to separate a portion of the balloon 130 from a portion of the tubular element 110. In one or more embodiments, the barrier 120 extends around the tubular element 110. According to an embodiment, the barrier 120 covers the entirety of the one or more holes 112. The barrier 120 can be applied to the tubular element 110 by any suitable method. For example, the barrier 120 can be a piece of material wrapped around the tubular element 110. In one or more embodiments, the barrier 120 is attached to the tubular element 110. The barrier 120 can fit tightly to the outside of the tubular element 110. Compared to current medical devices with balloons, the barrier 120 of the present disclosure can remain in place during the inflation and deflation of the balloon 130. According to an embodiment, the barrier 120 is not removed from the medical device 100 before use (e.g., inflation or deflation of the balloon 130).

[0048] The barrier 120 is generally permeable to air. During inflation, air passes from the interior lumen 114 of the tubular element 110 through the apertures 112, through the barrier 120, and into the balloon 130. The barrier 120 is generally impermeable to the material of the balloon 130, including when the material of the balloon is in solution. For example, if the balloon 130 comprises nitrile, the barrier 120 is generally impermeable to a solution of nitrile in a solvent. If the balloon 130 comprises silicone, the barrier 120 is generally impermeable to a solution of silicone in a solvent.

[0049] The barrier 120 can be formed of any suitable material. Suitable materials are permeable to air and impermeable to the material of the balloon in a solution (e.g., an elastomeric solution). In one or more embodiments, the barrier 120 comprises polytetrafluoroethylene (PTFE). In one or more embodiments, the barrier 120 comprises expanded PTFE (ePTFE). The barrier 120 can be a tubular sleeve, or it can be a piece of material applied to or wrapped around the tubular element 110.

[0050] The permeability of the barrier 120, particularly an ePTFE barrier, may be affected by its density. It may also be affected by parameters such as internode distance, pore density, porosity, pore size, etc. The pore density can be measured using any suitable assay. One measure of pore density commonly used for materials such as those compatible with use as a barrier is standard density. Generally speaking, higher pore density results in lower standard density. Therefore, standard density can be used as a proxy for inverse pore density.

[0051] In one or more embodiments, the barrier is composed of a 0.1 g / cm 3 or smaller, 0.2g / cm 3 or smaller, 0.4g / cm 3 or smaller, 0.6g / cm 3 or smaller, 0.8g / cm 3 or less, 1.0g / cm 3 or less, 1.2g / cm 3 or smaller, or 1.5g / cm 3 In one or more embodiments, the barrier has a density of 0.05 g / cm 3 or larger, 0.1g / cm 3 or larger, 0.3g / cm 3 or larger, 0.5g / cm 3 or larger, 0.7g / cm 3 or larger, 0.9g / cm 3 or greater, or 1.0g / cm 3 or greater standard density.

[0052] The internode distance, or the distance between the pores, can be measured using an optical microscope. According to an embodiment, the barrier 120 has an internode distance of 5 micrometers (μm) or more, 10 μm or more, 15 μm or more, 20 μm or more, 25 μm or more, 30 μm or more, 40 μm or more, 50 μm or more, 60 μm or more, 80 μm or more, or 100 μm or more. In one or more embodiments, the barrier 120 has an internode distance of 120 μm or less, 100 μm or less, 90 μm or less, 70 μm or less, 60 μm or less, or 40 μm or less.

[0053] According to an embodiment, the barrier 120 has a wall thickness of 0.02 millimeters (mm) or more, 0.04 mm or more, 0.06 mm or more, 0.08 mm or more, 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, 0.6 mm or more, or 1 mm or more. The barrier 120 can have a wall thickness of 2 mm or less, 1.5 mm or less, 1 mm or less, 0.7 mm or less, 0.5 mm or less, 0.4 mm or less, 0.3 mm or less, 0.1 mm or less, or 0.08 mm or less. The wall thickness of the barrier can range from 0.02 mm to 2 mm, 0.1 mm to 1.5 mm, or 0.2 mm to 1 mm.

[0054] In one or more embodiments, the medical device 100 includes one balloon 130. In some other embodiments, the medical device 100 includes more than one balloon 130, such as two or three balloons. Examples of medical devices that may include more than one balloon include catheters and dilators.

[0055] Balloon 130 is usually made of a material that can be repeatedly inflated and contracted. In one or more embodiments, balloon 130 includes an elastomer or is made of an elastomer. The elastomer can be a thermosetting elastomer or a thermoplastic elastomer. Suitable elastomers include silicone, natural rubber (e.g., latex), polyurethane or synthetic rubber such as chloroprene rubber or nitrile. In one or more embodiments, balloon 130 is made of silicone. It will be apparent to those of ordinary skill in the art that any suitable elastic material can be used.

[0056] In embodiments where the balloon 130 is made of a polymer, the polymer may have any suitable hardness. The hardness can be measured, for example, using a Shore durometer. Shore durometer is typically reported as an "A" or "D" hardness. Hardness measurements using a Shore durometer are described in more detail in U.S. Patent No. 1,770,045, published on July 8, 1930. Polymers suitable for use in elastomer solutions typically have a hardness of 40A or greater, 50A or greater, 60A or greater, 70A or greater, 80A or greater, or 90A or greater. Polymers suitable for use in elastomer solutions typically have a hardness of 100A or less, 95A or less, or 85A or less. The polymer may have a hardness of 65A to 95A or 70A to 90A or about 80A.

[0057] like Figures 1A to 1D As shown, the balloon 130 generally extends over the barrier 120 and the one or more apertures 112. Figures 1A to 1D In one or more embodiments of the examples shown in , the balloon 130 is bonded to the tubular wall 111, adjacent to the distal end 101 and the proximal end 102 of the barrier 120. That is, both the proximal portion 132 and the distal portion 134 of the balloon 130 are bonded to the tubular wall 111. The inflatable middle portion 135 is not bonded to the tubular wall 111. Figure 1B and Figure 1D As shown, when air is pushed into the tubular member 110, the inflatable middle portion 135 of the balloon 130 positioned on the barrier 120 expands and inflates. This creates an inflated portion 150 of the balloon 130. When air is pushed into the tubular member 110, the proximal portion 132 and the distal portion 134 of the balloon 130 that are not positioned on the barrier remain attached (e.g., bonded) to the tubular member 110.

[0058] exist Figure 2A and Figure 2B In an alternative embodiment of the medical device 200 shown, the balloon 230 is positioned at the distal end 201 of the tubular wall 211. The proximal portion 232 of the balloon is bonded to the tubular wall 211. That is, the balloon 230 can be bonded to the tubular wall 211, only adjacent to the proximal end of the barrier 220. The distal portion 234 of the balloon 230 forms an inflatable portion 235. The distal end 201 of the tubular element 210 can be at least partially sealed by a seal 240. An aperture 212 is disposed at or near the distal end 201. The barrier 220 is disposed around the distal end, covering the aperture 212. When air is pushed through the interior lumen 214 of the tubular element 210 and through the aperture 212 and the barrier 220, the inflatable portion 235 inflates, thereby forming an inflated portion 250. Figure 2A A schematic diagram of a medical device 200 is shown with a balloon 230 in a deflated configuration S1 . Figure 2B A schematic diagram of a medical device 200 is shown with a balloon 230 in an inflated configuration S2.

[0059] exist Figure 3A and Figure 3B In another alternative embodiment of the medical device 300 shown, the distal end 301 of the tubular wall 311 is covered by the balloon 330. However, one or more holes 312 are positioned along the tubular wall 311 (similar to Figures 1A to 1D 1 . The embodiment of the present invention is shown in FIG. 1 , and not at the distal end 301. The barrier 320 is disposed around the tubular wall 311 in the region of the one or more holes 312, such that the barrier 320 covers the one or more holes 312. The balloon 330 covers the distal end 301 of the tubular wall 311 and the barrier 320. A proximal portion 332 of the balloon 330 is bonded to the tubular wall 311. A distal portion 324 of the balloon 330 may also be bonded to the tubular wall 311. Alternatively, the distal portion 324 is not bonded to the tubular wall 311. An inflatable middle portion 325 of the balloon 330 is formed on the barrier 320 and can be inflated by forcing air through the interior lumen 314 of the tubular element 310 and through the one or more holes 312 and the barrier 320. Figure 3A A schematic diagram of a medical device 300 is shown with a balloon 330 in a deflated configuration S1 . Figure 3B A schematic diagram of a medical device 300 is shown with a balloon 330 in an inflated configuration S2.

[0060] In another aspect, the present disclosure is directed to a method of forming a medical device 100 , 200 , 300 including a balloon 130 , 230 , 330 . Figure 44. A diagram of an example of the method is shown in FIG. 400. The method 400 includes a first step 410 of applying a barrier 120, 220, 320 to at least a portion of a tubular element 110, 210, 310. The tubular element 110, 210, 310 includes a tubular wall 111, 211, 311 having a distal end 101, 201, 301 and a proximal end 102, 202, 302; and one or more holes 112, 212, 312 extending through the tubular wall 111, 211, 311 between the distal end and the proximal end. The barrier 120, 220, 320 is applied to the outside of the tubular element 110, 210, 310 and covers the one or more holes 112, 212, 312 extending through the tubular wall 111, 211, 311. The barrier 120, 220, 320 is permeable to air. The method also includes a second step 420 of applying an elastomeric solution to the outside of the tubular wall 111, 211, 311 to form a coating. The elastomeric solution can be applied, for example, by dipping the ends of the tubular wall 111, 211, 311 in the elastomeric solution. Other application methods can also be used, such as spraying, brushing, etc. The coating covers the barrier 120, 220, 320 and at least a portion of the tubular wall 111, 211, 311 adjacent to the barrier 120, 220, 320. The coating covers at least one axial end of the barrier 120, 220, 320. The coating can also cover the distal end of the tubular wall 111, 211, 311. The method then includes a third step 430 of curing the coating to form the balloon 130, 230, 330.

[0061] The barrier 120, 220, 320 is generally consistent with the materials and properties of the barriers described herein. In one or more embodiments, the barrier comprises ePTFE. The barrier is generally permeable to air but impermeable to the elastomeric solution used to prepare the coating. The barrier 120, 220, 320 is configured to prevent the elastomeric solution from blocking the one or more holes 112, 212, 312 extending through the tubular wall when the elastomeric solution is applied to the tubular element 110, 210, 310. It may be desirable that the elastomeric solution does not enter the interior lumen 114, 214, 314 of the tubular element 110, 210, 310.

[0062] In one or more embodiments, applying the barrier 120, 220, 320 includes wrapping a strip of material around the tubular element 110, 210, 310. In some other embodiments, applying the barrier includes positioning a tube of material around the tubular element 110, 210, 310. In one or more embodiments, the method further includes bonding the barrier 120, 220, 320 to the tubular element 110, 210, 310. It may be desirable to bond or otherwise attach the barrier 120, 220, 320 to the tubular element 110, 210, 310 to prevent movement of the barrier 120, 220, 320 during subsequent steps of the method.

[0063] In one or more embodiments, the method further comprises cleaning the tubular element 110, 210, 310. This step may occur at any suitable point in the method. Cleaning the tubular element after applying the barrier but before applying the elastomer solution may improve the bonding of the elastomer solution to the tubular element. In one or more embodiments, cleaning the tubular element comprises plasma cleaning and / or silicone cleaning.

[0064] Applying the elastomeric solution to the tubular element 110, 210, 310 typically includes applying a thin layer of the elastomeric solution to the barrier 120, 220, 320 and at least a portion of the tubular element 110, 210, 310 that is not covered by the barrier 120, 220, 320. In one or more embodiments, applying the elastomeric solution includes dipping the tubular element 110, 210, 310 into the elastomeric solution. In one or more embodiments, applying the elastomeric solution includes painting or stuccoing on a coating of the elastomeric solution. As described herein, the elastomeric solution typically covers the entire barrier 120, 220, 320 and at least a portion of the tubular element 110, 210, 310 that is not covered by the barrier 120, 220, 320. The elastomeric solution can be applied to the tubular element 110, 210, 310 adjacent to one or both axial ends of the barrier 120, 220, 320. The elastomer solution is typically applied in a manner that prevents the elastomer solution from entering the interior lumen 114, 214, 314 of the tubular element 110, 210, 310. The viscosity of the elastomer solution can be adjusted by varying the volume of solvent used. The thickness of the applied elastomer solution layer may be affected by the viscosity of the elastomer solution.

[0065] The elastomer solution may include any suitable component as described herein. In one or more embodiments, the elastomer solution includes an elastomer dissolved or suspended in a solvent. In one or more embodiments, the elastomer includes a polymer. The elastomer may include silicone, polyurethane, natural rubber (e.g., latex), synthetic rubber such as chloroprene rubber or nitrile, or a combination thereof. The polymer may have any suitable hardness as described herein. In one or more embodiments, the elastomer includes a monomer.

[0066] The elastomer can be a liquid elastomer, or it can be a solid elastomer. The elastomer can be cured after being applied to the tubular element. In some embodiments, the elastomer can be partially cured before application to reduce the curing time and / or temperature of the elastomer that cures after application. In one or more embodiments, the solvent can include an aqueous solvent, such as water. In one or more embodiments, the solvent can include one or more organic solvents. The organic solvent can include hexane, heptane, tetrahydrofuran, dimethylacetamide and other non-polar solvents. In one or more embodiments, the elastomer solution is a low hardness polyurethane solution in an organic solvent (such as tetrahydrofuran or dimethylacetamide).

[0067] In one or more embodiments, one or more additional layers of elastomeric solution may be applied to the tubular element 110, 210, 310. Additional layers of elastomeric solution may be applied before a previous layer is cured, when a previous layer is partially cured, or when a previous layer is fully cured. In one or more embodiments, at least 1 layer, at least 2 layers, at least 3 layers, at least 4 layers, at least 5 layers, or at least 6 layers of elastomeric solution are applied to the tubular element 110, 210, 310. In one or more embodiments, at most 10 layers, at most 8 layers, at most 7 layers, at most 6 layers, at most 5 layers, at most 4 layers, at most 3 layers, or at most 2 layers of elastomeric solution are applied to the tubular element 110, 210, 310. In embodiments where multiple layers are applied, each layer may be applied to substantially the same area of ​​the tubular element 110, 210, 310 such that the layers partially or completely overlap.

[0068] Curing the elastomer solution typically includes curing the elastomer solution so that it is solid and no longer reactive. Curing conditions may depend on the type of elastomer and solvent used to prepare the coating. In one or more embodiments, curing the elastomer solution includes drying. Drying can be carried out at ambient temperature, or it can be carried out at an elevated temperature. As used herein, "ambient temperature" refers to the temperature of the manufacturing space, typically between 20°C and 30°C. In one or more embodiments, curing the elastomer solution includes applying energy to the coating, such as ultraviolet radiation. The elastomer solution can be cured for any suitable amount of time sufficient to cure the elastomer. For example, the curing time can be as short as a few minutes and as long as a few days. In one or more embodiments, the elastomer solution is cured for 1 hour to 72 hours, 2 hours to 48 hours, or 4 hours to 24 hours.

[0069] According to an embodiment, the method of manufacturing the medical device does not include removing the barrier from the device. That is, the barrier remains a part of the medical device, which is disposed between the tubular element and the balloon.

[0070] In another aspect, the present disclosure relates to a method of using a medical device 100, 200, 300 including a balloon 130, 230, 330. The method can be applied to any medical device including a balloon described herein. The method includes pushing air through the proximal end to penetrate the barrier 120, 220, 320 and inflate the balloon 130, 230, 330. This creates an inflated portion 150 of the balloon 130. In Figures 1A to 3B In the embodiment, the deflated state of the balloon is marked as "S1", and the inflated state of the balloon is marked as "S2". Figure 1B , Figure 1D , Figure 2B and Figure 3B As shown in Figure 1B As shown, the distal end 101 of the tubular element is closed with a seal 140, and air is pushed into the tubular element through the proximal end 102. The balloon 130 is attached to the tubular element 110 on both axial ends of the barrier 120. When the air is pushed through the proximal end 102, the air flows through the one or more holes 112 and through the barrier 120. Thus, the inflatable middle portion 135 (the portion of the balloon 130 covering the barrier 120) is inflated to form a medical device including a balloon having an inflated portion 150, as shown in FIG. Figure 1B and Figure 1D shown.

[0071] According to an embodiment, the method of using the medical device does not include removing the barrier from the device. That is, the barrier remains a part of the medical device during use, the part being disposed between the tubular element and the balloon.

[0072] Different shapes of inflated balloons can result from different methods of balloon production. Figure 2B An example of a medical device 200 having a balloon 230 is shown, wherein the balloon 230 is coupled to a tubular element 210 adjacent to a distal end 201 of the tubular element 210. The distal end 201 is sealed with a seal 240, and there is one hole 212 at or near the distal end 201. The hole 212 is covered by a barrier 220. When air is pushed into the proximal end 202, the air passes through the one or more holes 212 and the barrier 220 and into the balloon 230. Figure 2B The shape of the inflated portion 250 is different from Figure 1B The shape of the inflated portion 150 is due to its placement at the tip of the tubular element 210. Each of these shapes can provide certain advantages in different applications.

[0073] Exemplary embodiments

[0074] Embodiment 1 is a medical device comprising a balloon, the medical device comprising:

[0075] a. a tubular element comprising a tubular wall including a distal end and a proximal end, the tubular element comprising one or more holes passing through the tubular wall between the distal end and the proximal end;

[0076] b. a balloon extending diametrically around the tubular wall, wherein the balloon is bonded to at least a portion of the tubular wall, and wherein at least a portion of the balloon is not bonded to the tubular wall; and

[0077] c. A barrier located between the tubular wall and the balloon, the barrier covering the one or more holes and being permeable to air.

[0078] Embodiment 2 is a medical device according to embodiment 1, wherein the tubular wall comprises a polymer, glass or metal.

[0079] Embodiment 3 is a medical device according to embodiment 2, wherein the polymer comprises a thermoplastic.

[0080] Embodiment 4 is a medical device according to embodiment 3, wherein the thermoplastic comprises polyurethane, polyether block amide, CARBOTHANE or PELLETHANE.

[0081] Embodiment 5 is a medical device according to any one of embodiments 1 to 4, wherein the medical device comprises an internal lumen.

[0082] Embodiment 6 is the medical device according to any one of embodiments 1 to 5, wherein one axial end of the tubular element is sealed.

[0083] Embodiment 7 is a medical device according to any one of embodiments 1 to 6, wherein the medical device comprises a guide wire.

[0084] Embodiment 8 is a medical device according to embodiment 7, wherein the lead comprises one or more electrodes.

[0085] Embodiment 9 is a medical device according to any one of embodiments 7 or 8, wherein the guide wire includes a fixation element.

[0086] Embodiment 10 is a medical device according to any one of embodiments 1 to 9, wherein the medical device comprises a catheter.

[0087] Embodiment 11 is the medical device of any one of embodiments 1 to 10, wherein the tubular element comprises more than one hole through the tubular wall.

[0088] Embodiment 12 is a medical device according to embodiment 11, wherein the holes are arranged radially along the axial plane of the tubular element.

[0089] Embodiment 13 is a medical device according to any one of embodiments 1 to 12, wherein the balloon comprises an elastomer.

[0090] Embodiment 14 is a medical device according to embodiment 13, wherein the elastomer is a thermosetting elastomer.

[0091] Embodiment 15 is a medical device according to embodiment 13, wherein the elastomer is a thermoplastic elastomer.

[0092] Embodiment 16 is a medical device according to embodiment 13, wherein the elastomer comprises silicone, natural rubber (e.g., latex), synthetic rubber such as neoprene or nitrile.

[0093] Embodiment 17 is a medical device according to any one of embodiments 1 to 16, wherein the balloon is bonded to the tubular wall adjacent to both axial ends of the barrier.

[0094] Embodiment 18 is a medical device according to any one of embodiments 1 to 17, wherein the barrier has a thickness of 1.0 g / cm 3 or less density.

[0095] Embodiment 19 is a medical device according to any one of embodiments 1 to 18, wherein the barrier has a wall thickness of 0.2 mm or less.

[0096] Embodiment 20 is the medical device of any one of embodiments 1 to 19, wherein the barrier comprises polytetrafluoroethylene (PTFE).

[0097] Embodiment 21 is a medical device according to embodiment 20, wherein the PTFE comprises expanded PTFE (ePTFE).

[0098] Embodiment 22 is a method of forming a medical device including a balloon, the method comprising:

[0099] d. applying a barrier to at least a portion of a tubular element, the tubular element comprising a tubular wall having a distal end and a proximal end and one or more holes through the tubular wall between the distal end and the proximal end, the barrier covering the one or more holes and being permeable to air;

[0100] e. applying an elastomeric solution to the outside of the tubular wall to form a coating covering the barrier and at least a portion of the tubular wall on at least one axial end of the barrier; and

[0101] f. Curing the coating to form the balloon.

[0102] Embodiment 23 is a method according to embodiment 22, wherein the barrier comprises ePTFE.

[0103] Embodiment 24 is a method according to embodiment 22 or 23, wherein applying the barrier comprises wrapping a strip of material around the tubular element.

[0104] Embodiment 25 is the method of any one of embodiments 22 to 24, further comprising bonding the barrier to the tubular element.

[0105] Embodiment 26 is a method according to any one of embodiments 22 to 25, wherein the barrier remains in place after the coating is cured.

[0106] Embodiment 27 is a method according to any one of embodiments 22 to 26, further comprising cleaning the tubular element.

[0107] Embodiment 28 is a method according to embodiment 27, wherein cleaning comprises plasma cleaning or siloxane removal.

[0108] Embodiment 29 is a method according to embodiments 22 to 28, further comprising repeatedly applying the elastomer solution to substantially the same area to form multiple coatings.

[0109] Embodiment 30 is a method according to embodiment 29, wherein a total of three coatings are applied.

[0110] Embodiment 31 is a method according to any one of embodiments 22 to 30, wherein applying the elastomer solution comprises dipping.

[0111] Embodiment 32 is a method according to any one of embodiments 22 to 31, wherein the elastomer solution comprises silicone, natural rubber (e.g., latex), synthetic rubber such as neoprene, or nitrile.

[0112] Embodiment 33 is a method according to any one of embodiments 22 to 32, wherein the elastomer solution comprises one or more organic solvents.

[0113] Embodiment 34 is a method according to any one of embodiments 22 to 33, wherein the elastomer solution is cured for at least 24 hours.

[0114] Embodiment 35 is a method of using the medical device of any one of embodiments 1 to 21, the method comprising pushing air through the proximal end to permeate the barrier and inflate the balloon.

[0115] Example

[0116]

[0117] Example 1

[0118] In this embodiment, a medical device having a balloon is formed by dip coating.

[0119] A thin wall polyurethane tube was obtained. Two holes were cut in the wall of the tube at a radial interval of 180 degrees in the middle section of the tubular element. A strip of 0.006" (approximately 0.15 mm) wall ePTFE was placed radially around the holes, completely covering each hole. The ePTFE strip was tightly wrapped around the tube. The tube with ePTFE was plasma cleaned for 10 minutes. The cleaned tube was then immersed in a MED1137 silicone solution diluted 1:2 with N-heptane. The tube was immersed two more times for a total of three coatings. The silicone solution was dried for 24 hours.

[0120] After the silicone had dried, one end of the tube was closed and the other end was attached to an inflation syringe. The balloon was inflated and observed to release from the ePTFE strip but remain bonded to the tube. The resulting balloon was Figure 5 shown.

[0121] As can be seen from this example, ePTFE can be used as a barrier in the manufacture of medical devices including silicone balloons.

[0122] Example 2

[0123] A 4 inch length of steel tubing was obtained. A circular saw was used to cut slots in the tubing for inflation. Fig. 6A An example of a steel tube with an inflation slot is shown in FIG. A tube of 0.012" (approximately 0.30 mm) wall ePTFE with a length of approximately 1.3 cm is slid over the tube, covering the inflation slot. Each end of the ePTFE tube is bonded to the steel tube using UV curable glue. The tube is dipped into the latex solution and slowly removed to form an even coating. The coating is allowed to dry for 20 minutes and then dipped again to form a second coating. The coating is allowed to dry for 24 hours. Figure 6B An example of a steel pipe with a dry latex coating is shown in .

[0124] The needle is inserted into one end of the steel tube and used to inject approximately 2 cm. 3 Before radial expansion, the latex is partially released from the ePTFE liner. Figure 6C An example of a steel tube with an inflated latex balloon is shown in .

[0125] As can be seen from this example, the 0.012" wall ePTFE tubing allowed for partial inflation of the latex balloon.

[0126] Example 3

[0127] A latex balloon was prepared on a steel tube as described in Example 2. A tube of 0.0022" (approximately 0.056 mm) wall ePTFE was used as the barrier instead of the 0.012" wall ePTFE tube. A 2 cm 3 The needle of air inflates the balloon. Prior to radial expansion, the latex is partially released from the ePTFE liner.

[0128] As can be seen from this example, the 0.0022" wall ePTFE tubing allowed for partial inflation of the latex balloon.

[0129] Example 4

[0130] A latex balloon was prepared on a steel tube as described in Example 2. A 0.006" (approximately 0.15 mm) wall ePTFE tube was used instead of a 0.012" wall ePTFE tube as a barrier. A 2 cm 3 A needle of air inflated the balloon. The latex released acceptably from the ePTFE liner and inflated acceptably.

[0131] From this example, it can be seen that an ePTFE liner with a 0.006" wall allows acceptable inflation of a latex balloon. From the results of Examples 2 and 3, it can be seen that an ePTFE liner with a wall of up to 0.006" performs better than an ePTFE liner with a thicker wall.

[0132] The present application is intended to cover any modification or variation of the specific embodiments discussed herein. Therefore, the present disclosure is intended to be limited only by the claims and their equivalents. The disclosed embodiments are presented for the purpose of illustration and not limitation, and although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that the specific embodiments shown and described may be replaced with a variety of alternative and / or equivalent implementations without departing from the scope of the present disclosure.

[0133] The following examples are a non-limiting list of clauses in accordance with one or more techniques of the present disclosure.

[0134] Embodiment 1. A medical device, comprising: a tubular element, the tubular element comprising a tubular wall having a distal end and a proximal end, the tubular element comprising an internal lumen and one or more holes passing through the tubular wall between the distal end and the proximal end; a balloon, the balloon extending along a diameter around the tubular wall, wherein the balloon is coupled to at least a portion of the tubular wall, and wherein at least a portion of the balloon is not coupled to the tubular wall; and a barrier, the barrier being located between the tubular wall and the balloon, the barrier covering the one or more holes and being permeable to air.

[0135] Embodiment 2. The medical device of embodiment 1, wherein one axial end of the tubular element is sealed.

[0136] Embodiment 3. The medical device of Embodiment 1, wherein the tubular element comprises more than one hole through the tubular wall.

[0137] Embodiment 4. The medical device of Embodiment 1, wherein the tubular wall comprises a polymer, glass, or metal.

[0138] Example 5. The medical device of Example 1, wherein the balloon comprises an elastomer.

[0139] Embodiment 6. The medical device of Embodiment 5, wherein the elastomer comprises silicone, natural rubber, neoprene, nitrile, or a combination thereof.

[0140] Example 7. The medical device of Example 1, wherein the balloon is bonded to the tubular wall adjacent to both axial ends of the barrier.

[0141] Embodiment 8. The medical device of embodiment 1, wherein the barrier has a thickness of 1.0 g / cm 3 or less density.

[0142] Embodiment 9. The medical device of Embodiment 1, wherein the barrier has a wall thickness of 0.2 mm or less.

[0143] Embodiment 10. The medical device of Embodiment 1, wherein the barrier comprises polytetrafluoroethylene (PTFE).

[0144] Embodiment 11. The medical device of embodiment 10, wherein the PTFE comprises expanded PTFE (ePTFE).

[0145] Example 12. A method for forming a medical device including a balloon, the method comprising: applying a barrier to at least a portion of a tubular element, the tubular element comprising a tubular wall having a distal end and a proximal end and one or more holes passing through the tubular wall between the distal end and the proximal end, the barrier covering the one or more holes and being air permeable; applying an elastomeric solution to the outside of the tubular wall to form a coating, the coating covering the barrier and at least a portion of the tubular wall on at least one axial end of the barrier; and curing the coating to form a balloon.

[0146] Embodiment 13. The method of embodiment 12, wherein applying the elastomer solution comprises dipping.

[0147] Embodiment 14. The method of Embodiment 12, wherein the barrier comprises ePTFE.

[0148] Embodiment 15. The method of embodiment 12, wherein the barrier remains in place after the coating is cured.

[0149] Embodiment 16. The method of embodiment 12, further comprising cleaning the tubular element.

[0150] Embodiment 17. The method of embodiment 12 further comprising repeatedly applying the elastomer solution to substantially the same area to form multiple coatings.

[0151] Embodiment 18. The method of embodiment 12, wherein the elastomer solution comprises silicone, natural rubber, neoprene, nitrile, or a combination thereof.

[0152] Embodiment 19. The method of embodiment 12, wherein the elastomer solution comprises one or more organic solvents.

[0153] Embodiment 20. A method of using the medical device of Embodiment 1, the method comprising pushing air through the proximal end to permeate the barrier and inflate the balloon.

Claims

1. A medical device, comprising: a tubular element comprising a tubular wall having a distal end and a proximal end, the tubular element including an interior lumen and one or more holes through the tubular wall between the distal end and the proximal end; a balloon extending diametrically about the tubular wall, wherein the balloon is bonded to at least a portion of the tubular wall, and wherein at least a portion of the balloon is not bonded to the tubular wall; and A barrier is located between the tubular wall and the portion of the balloon not bonded to the tubular wall, the barrier covering the one or more apertures and being permeable to air.

2. The medical device according to claim 1, wherein: One axial end of the tubular element is sealed.

3. The medical device according to claim 1 or 2, wherein: The tubular element includes more than one aperture through the tubular wall.

4. The medical device according to any one of the preceding claims, wherein: The tubular wall comprises a polymer, glass or metal.

5. The medical device according to any one of the preceding claims, wherein: The balloon includes an elastomer.

6. The medical device according to claim 5, wherein: The elastomer comprises silicone, natural rubber, neoprene, nitrile or a combination thereof.

7. A medical device according to any one of the preceding claims, wherein: The balloon is bonded to the tubular wall adjacent to both axial ends of the barrier.

8. The medical device according to any one of the preceding claims, wherein: The barrier has a 1.0 g / cm 3 or less density.

9. The medical device according to any one of the preceding claims, wherein: The barrier has a wall thickness of 0.2 mm or less.

10. The medical device according to any one of the preceding claims, wherein: The barrier comprises polytetrafluoroethylene (PTFE).

11. The medical device according to claim 10, wherein: The PTFE includes expanded PTFE (ePTFE).

12. A method of forming a medical device comprising a balloon, the method comprising: providing a tubular element comprising a tubular wall having a distal end and a proximal end, the tubular element comprising an interior lumen and one or more holes through the tubular wall between the distal end and the proximal end; applying a barrier to at least a portion of the tubular element such that the barrier covers the one or more apertures of the tubular element, wherein the barrier is permeable to air; applying an elastomeric solution to the outside of the tubular wall and the barrier to form a coating covering the barrier and at least a portion of the tubular wall on at least one axial end of the barrier; as well as The coating is cured to form the balloon, wherein injecting air through the interior lumen forces the air through the one or more holes and the barrier to expand the balloon.

13. The method according to claim 12, wherein: The barrier comprises ePTFE, and wherein applying the elastomeric solution comprises dipping the barrier and at least a portion of the tubular element into the solution.

14. The method according to claim 13, wherein: The dipping process is repeated multiple times to form multiple coatings.

15. The method according to any one of claims 12 to 14, further comprising cleaning the portion of the tubular element to which the elastomer solution is to be applied, wherein Cleaning the tubular element includes at least one of plasma cleaning or silicone cleaning.

Images