WO2025226570A1

WO2025226570A1 - A method of making a medical balloon and a medical balloon

Info

Publication number: WO2025226570A1
Application number: PCT/US2025/025546
Authority: WO
Inventors: Jeong Soo Lee; Phu Vinh LE
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-04-22
Filing date: 2025-04-21
Publication date: 2025-10-30
Anticipated expiration: 2026-10-22

Abstract

A method of making a medical balloon comprising removing a layer of a molded multiple-layer balloon wall. A medical balloon comprising a wall manufactured by the above method. The method comprises: heating an elongate tube (152) having a wall including three or more layers (100, 102, 104) to a first temperature; radially stretching the wall of the elongate tube (152) within a mold (150) to form a molded elongate tube (152) having the stretched wall; and removing a layer (104) of the three or more layers (100, 102, 104) of the stretched wall to form the balloon, the balloon being expandable through pressure applied to an inner surface of the balloon.

Description

BALLOON COMPOSITIONS FOR IMPLANT DEPLOYMENT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/637,212, filed April 22, 2024, the entire contents of which is incorporated herein by reference.

BACKGROUND

[0002] A variety of maladies may affect an individual’s body. Such maladies may be of the individual’s heart, and may include maladies of the individual’s heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual’s overall wellbeing.

[0003] Implants may be provided that may replace or repair portions of a patient’s heart. Prosthetic implants, such as prosthetic heart valves, may be provided to replace a portion of a patient’s heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

[0004] Implants may be deployed to the desired portion of the patient’s body percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual.

[0005] During deployment of such implants, the implants must be dilated to provide an expanded configuration for such implant. Care must be taken to properly dilate the implants to avoid over expansion or under expansion of such implants and to properly deploy such an implant. Care must also be taken to avoid rupture of a balloon utilized to deploy such an implant.

SUMMARY

[0006] The present devices, systems, and methods may relate to balloon compositions that may be for deployment of implants within a patient’s body. The balloons in examples may be utilized for dilating implants and may be coupled to a delivery catheter for the implant. In examples, the balloons may be utilized to dilate other surfaces within the patient’s body (e.g., to dilate calcified heart valve leaflets and/or angioplasty procedures, among other surfaces).

[0007] The balloons may provide improved deployment of implants, including a reduced possibility of undesired movement of an implant during deployment. The balloons may have further benefits including an increased possibility of tear in a longitudinal dimension as opposed to a radial dimension, a reduced inflation pressure for the balloon, a reduced wall thickness, and a reduced possibility of one or more layers of the balloon bursting during molding and/or use of the balloon. In examples, the balloons may have improved compliance properties to enhance the ease of a deployment procedure for the implant. In examples, the balloons may have a reduced possibility of one or more layers of the balloon crystallizing during molding of the balloon.

[0008] Examples herein may include a method of making a balloon for insertion within a portion of a patient’s body. The method may comprise heating an elongate tube having a wall including three or more layers to a first temperature. The method may comprise radially stretching the wall of the elongate tube within a mold to form a molded elongate tube having the stretched wall. The method may comprise removing a layer of the three or more layers of the stretched wall to form the balloon, the balloon being expandable through pressure applied to an inner surface of the balloon.

[0009] Examples herein may include a device for insertion within a portion of a patient’s body. The device may comprise a balloon having a blow molded wall including: an inner surface, a first layer, and a second layer positioned radially outward of the first layer, wherein the balloon is expandable through pressure applied to the inner surface of the blow molded wall, the blow molded wall being formed by: blow molding an elongate tube to form a blow molded elongate tube having the first layer, the second layer, and a third layer positioned radially outward of the second layer, the third layer being an insulation layer to reduce crystallization of the second layer during the blow molding, and removing the third layer from the blow molded elongate tube.

[0010] Examples herein may include a device for insertion within a portion of a patient’s body. The device may comprise a balloon having a wall including: an inner surface, an inner layer comprising a polyamide or a co-polyamide, an outer layer positioned radially outward of the inner layer and comprising a polyester or a co-polyester, and an intermediate layer positioned between the inner layer and the outer layer and bonding the outer layer to the inner layer, the intermediate layer comprising a copolymer having a polyether segment and a polyamide segment, wherein the balloon is expandable through pressure applied to the inner surface of the wall.

[0011] Examples herein may include a method of delivering an expandable implant to a portion of a patient’ s body. The method may comprise inserting a balloon into the patient’ s body, the balloon having a blow molded wall including: an inner surface, a first layer, and a second layer positioned radially outward of the first layer, wherein the balloon is expandable through pressure applied to the inner surface of the blow molded wall, the blow molded wall being formed by: blow molding an elongate tube to form a blow molded elongate tube having the first layer, the second layer, and a third layer positioned radially outward of the second layer, the third layer being an insulation layer to reduce crystallization of the second layer during the blow molding, and removing the third layer from the blow molded elongate tube. The method may comprise expanding the balloon through pressure applied to the inner surface of the blow molded wall to expand the expandable implant at the portion of the patient’s body.

[0012] Examples herein may include a method of delivering an expandable implant to a portion of a patient’ s body. The method may comprise inserting a balloon into the patient’ s body, the balloon having a wall including: an inner surface, an inner layer comprising a polyamide or a co-polyamide, an outer layer positioned radially outward of the inner layer and comprising a polyester or a co-polyester, and an intermediate layer positioned between the inner layer and the outer layer and bonding the outer layer to the inner layer, the intermediate layer comprising a copolymer having a polyether segment and a polyamide segment, wherein the balloon is expandable through pressure applied to the inner surface of the wall. The method may comprise expanding the balloon through pressure applied to the inner surface of the wall to expand the expandable implant at the portion of the patient’ s body.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar examples.

[0014] FIG. 1 illustrates a perspective view of a tapered balloon according to an example of the present disclosure.

[0015] FIG. 2 illustrates a cross sectional view of the tapered balloon shown in FIG. 1.

[0016] FIG. 3 illustrates a side view of a delivery catheter according to an example of the present disclosure.

[0017] FIG. 4 illustrates a close up view of a distal end of the delivery catheter shown in FIG. 3.

[0018] FIG. 5 illustrates a chart of a crimped outer diameter of an implant.

[0019] FIG. 6 illustrates a cross sectional view of a step of manufacture of a balloon according to an example of the present disclosure.

[0020] FIG. 7 illustrates a perspective view of an elongate tube during manufacture of the balloon according to an example of the present disclosure.

[0021] FIG. 8 illustrates an exterior view of the elongate tube of FIG. 7 in a subsequent step of manufacture of the balloon according to an example of the present disclosure.

[0022] FIG. 9 illustrates a cross sectional view of a mold in a subsequent step of manufacture of the balloon according to an example of the present disclosure. [0023] FIG. 10 illustrates a perspective view of the elongate tube of FIG. 8 having been blow molded according to an example of the present disclosure.

[0024] FIG. 11 illustrates a perspective view of the molded elongate tube of FIG. 10 in a subsequent step of manufacture of the balloon according to an example of the present disclosure.

[0025] FIG. 12 illustrates a perspective view of the molded elongate tube of FIG. 11 having had an outer layer of the molded elongate tube removed according to an example of the present disclosure.

[0026] FIG. 13 illustrates a cross sectional view of a tapered balloon according to an example of the present disclosure.

[0027] FIG. 14 illustrates a cross sectional view of a step of manufacture of a balloon according to an example of the present disclosure.

[0028] FIG. 15 illustrates a perspective view of an elongate tube during manufacture of the balloon according to an example of the present disclosure.

[0029] FIG. 16 illustrates an exterior view of the elongate tube of FIG. 15 in a subsequent step of manufacture of the balloon according to an example of the present disclosure.

[0030] FIG. 17 illustrates a cross sectional view of a mold in a subsequent step of manufacture of the balloon according to an example of the present disclosure.

[0031] FIG. 18 illustrates a chart of a balloon compliance of examples of balloons according to examples of the present disclosure.

[0032] FIG. 19 illustrates an implant in the form of a valve crimped to a balloon according to an example of the present disclosure.

[0033] FIG. 20 illustrates the balloon shown in FIG. 19 partially expanded.

[0034] FIG. 21 illustrates a schematic view of an implant approaching an implantation site according to an example of the present disclosure.

[0035] FIG. 22 illustrates a schematic view of the implant shown in FIG. 21 deployed to an implantation site according to an example of the present disclosure.

[0036] FIG. 23 illustrates a perspective view of an implant according to an example of the present disclosure.

[0037] FIG. 24 illustrates a top view of the implant shown in FIG. 23 according to an example of the present disclosure.

[0038] FIG. 25 illustrates a top view of the implant shown in FIG. 23 according to an example of the present disclosure.

DETAILED DESCRIPTION [0039] The following description illustrates some examples of the disclosure in detail. Those of skill in the art will recognize that there are numerous variations and modifications of the disclosure that are encompassed by its scope. Accordingly, the description of a certain example should not be deemed to limit the scope of the present disclosure.

[0040] FIG. 1 illustrates a perspective view of a balloon 10 according to an example of the present disclosure. The balloon 10 may have a wall 14 and may be expandable through pressure applied to an inner surface of the wall 14. The balloon 10 may be configured for insertion within a portion of a patient’s body.

[0041] The balloon 10, in examples, may include a first end portion 16 and a second end portion 18 and a length between the first end portion 16 and the second end portion 18. A central portion 20 may be positioned between the first end portion 16 and the second end portion 18.

[0042] The first end portion 16 may couple to a shaft 22, which may comprise an elongate shaft 22 of a delivery catheter according to examples herein. The first end portion 16 may taper outwardly in a distal direction towards the central portion 20.

[0043] The second end portion 18 may be positioned at a distal end of the central portion 20, and may taper inwardly in a distal direction to the end of the balloon 10. A nose cone 24 (marked in FIG. 2, yet not shown in FIG. 1) may be positioned at the end of the balloon 10 in examples, although a nose cone may not be utilized in certain examples.

[0044] The central portion 20 may be positioned between the first end portion 16 and the second end portion 18 and may be configured to apply a radially outward force to an implant that is positioned upon the central portion 20 or apply the radially outward force to another surface for dilation by the balloon 10.

[0045] The balloon 10 may have an elongate shape that extends along a longitudinal axis 26 (marked in FIG. 2) and may be symmetrical about the longitudinal axis 26. The balloon 10 may be positioned radially outward from the longitudinal axis 26 and thus extends in a radial dimension 28 (marked in FIG. 2) outward from the longitudinal axis 26.

[0046] The balloon 10 may have a tapered profile. Specifically, as shown in FIGS. 1 and 2, the central portion 20 for applying the force to the implant or other surface, may have a tapered profile. The direction of the taper may vary according to the desired implementation of the balloon 10. For example, as shown in FIG. 2, the central portion 20 may taper inward in a distal direction. In examples however, the central portion 20 may taper outward in a distal direction. The taper may result in the central portion 20 having a larger diameter 33 at a proximal end than the diameter 35 at a distal end of the central portion 20 as shown in FIG. 2. The central portion 20 may have a length 37 along the longitudinal axis 26 as shown in FIG. 2. [0047] In other examples herein, however, the central portion 20 and balloon 10 may lack a taper and may have a cylindrical shape or another shape as desired.

[0048] FIG. 2 illustrates a cross sectional view of the balloon 10 shown in FIG. 1. The wall 14 of the balloon is shown in cross section to include an outer surface 30 facing opposite an inner surface 32. The outer surface 30 may comprise the portion of the balloon 10 that contacts an implant or a surface of another structure for dilation. In examples however, a coating or other structure may be positioned on the outer surface 30 of the wall 14 as desired, to form the outer surface of the balloon 10. The outer surface 30 at the central portion 20 may have a tapered profile.

[0049] The inner surface 32 may face an interior chamber 34 or fluid chamber that the wall 14 surrounds. The inner surface 32 may have pressure applied to it to expand the balloon 10. The interior chamber 34 may be configured to receive fluid for expanding the balloon 10. The interior chamber 34 for example may be filled with fluid, such as a liquid, to apply the pressure to the inner surface 32 and expand the balloon 10. The interior chamber 34 may be configured to receive fluid that fills the interior chamber 34 at a desired time, and may be configured for fluid to be withdrawn from the interior chamber 34 at a desired time to deflate the balloon 10.

[0050] A fluid lumen 36, for example, may be configured to supply fluid to the interior chamber 34 and withdraw fluid from the interior chamber 34. The fluid lumen 36 may be configured for inflation and/or deflation of the balloon 10. The fluid lumen 36 may extend centrally within the balloon 10 along the longitudinal axis 26 as shown in FIG. 2, or may have another configuration as desired. A proximal end of the fluid lumen 36 may extend to a fluid port 40 of a delivery catheter as shown in FIG. 3 for example, or to another location as desired.

[0051] The fluid lumen 36 may include one or more channels 42 that may be utilized to supply fluid to or from the interior chamber 34 from the fluid lumen 36. In examples, the channels 42 may be positioned proximally with respect to the interior chamber 34, although other locations may be utilized in examples as desired.

[0052] The fluid lumen 36 may comprise a central shaft that extends through the balloon 10, or may end at a proximal portion of the balloon 10. One or more shafts may extend through the balloon 10 to the second end portion 18 or distal end portion of the balloon 10. The shafts, for example, may include the fluid lumen 36 or may include other structures such as a guide wire lumen (not shown). The shafts may extend to and couple with the nose cone 24 or other structure positioned at the distal end portion of the balloon 10. In examples, a structure such as a distal shoulder 44 may be coupled to a shaft. [0053] FIGS. 1 and 2 illustrate the balloon 10 in an inflated or expanded state, in which the balloon 10 is filled with fluid. A tapered profile of the balloon 10 is visible.

[0054] FIG. 3 illustrates a side view of an example of the balloon 10 in a deflated or unexpanded state, along with a delivery catheter 50 that may include the balloon 10. The delivery catheter 50 as shown in FIG. 3 may include an elongate shaft 52 having a proximal end portion 54 and a distal end portion 56. The elongate shaft 52 may comprise an elongate body that may be flexible to allow for deflection of the elongate shaft 52 upon insertion into a patient’s body. The elongate shaft 52 may include multiple sheaths or shafts. For example, a shaft 22 as shown in FIG. 1 may be incorporated within the elongate shaft 52 as desired. An elongate shaft 52 having a single sheath or shaft may be utilized in examples.

[0055] The proximal end portion 54 of the elongate shaft 52 may couple to a housing in the form of a handle 58 that may be configured to be gripped by a user to control operation of the elongate shaft 52. The handle 58 may be manipulated to cause the elongate shaft 52 to be advanced or retracted within a patient’s body to place the elongate shaft 52 in the desired orientation relative to an implantation site. The handle 58 may include an outer surface 60 configured to be gripped.

[0056] A control mechanism 62 may be included with the handle 58 and may be configured to be operated to deflect the elongate shaft 52 in examples. The control mechanism 62, for example, may comprise one or more actuators in the form of control knobs 64 or other actuators that may be utilized to deflect the elongate shaft 52. The control mechanism 62 may include pull tethers or other structures that may be utilized to deflect the elongate shaft 52 via tension applied to the pull tethers. In examples, other forms of control mechanisms may be utilized as desired.

[0057] A fluid port 40 may be positioned on the handle 58 that may be configured to pass fluid to or withdraw fluid from the fluid lumen 36 shown in FIG. 2 for example. The fluid port 40 may couple to a fluid actuator or other device utilized to fill or withdraw fluid from the interior chamber 34 shown in FIG. 2.

[0058] The distal portion or distal end portion 56 of the elongate shaft 52 may include the balloon 10. The balloon 10 is shown in a deflated or unexpanded state, which may be a state for insertion of the elongate shaft 52 into the patient’s body with an implant positioned thereon.

[0059] FIG. 4, for example, illustrates a close up view of the distal end portion 56, showing the balloon 10 in the deflated or unexpanded state. Positions of the first end portion 16, the second end portion 18, and the central portion 20 are shown relative to the position of a central shaft, which may comprise the fluid lumen 36. The second end portion 18 is shown to comprise a distal shoulder 66 positioned over the distal shoulder 44 of the central shaft, and the first end portion 16 is shown to comprise a proximal shoulder 68. An implant retention area 70 may include the central portion 20 of the balloon 10 and may be positioned between the distal shoulder 66 and the proximal shoulder 68. The implant retention area 70 may have a length 72, and may have a diameter that is less than a diameter of the distal shoulder 66 and the proximal shoulder 68.

[0060] The implant that may be positioned at the implant retention area 70 may have a variety of forms. FIGS. 23-25 for example, illustrate a form of an implant 80 that may be utilized according to examples herein. FIG. 23 illustrates a perspective view of the implant 80, in the form of a prosthetic heart valve. The prosthetic implant 80 may be configured to be deployed within a portion of a patient’s body. The prosthetic implant 80, for example, may be deployed within a native heart valve annulus, which may comprise a native aortic valve, or in examples may comprise a native mitral, tricuspid, or pulmonary valve. In examples, the implant 80 may have other forms, and may comprise a stent or other form of medical implant as desired.

[0061] The prosthetic implant 80 may include a proximal or first end 82 and a distal or second end 84, and a length therebetween. The prosthetic implant 80 may include a body in the form of a frame 86. The prosthetic implant 80 may further include one or more of a plurality of leaflets 88a-c (marked in FIGS. 24 and 25) coupled to the frame 86 and may include a skirt 90 covering an outer surface of a distal portion of the frame 86. The leaflets 88a-c may move back and forth between open and closed positions or states or configurations to replicate the motion of a native valve. The leaflets 88a-c may extend inward from an inner surface of the implant 80 that the balloon 10 may exert a force against to dilate the implant 80.

[0062] The leaflets 88a-c may be configured to open and close during operation such that the first end 82 of the implant 80 forms an outflow end of the implant 80, and the second end 84 of the implant 80 forms an inflow end of the implant 80. The leaflets 88a-c may be configured to impede fluid flow in an opposite direction from the outflow end to the inflow end of the implant 80 when the leaflets 88a-c are in a closed position.

[0063] The frame 86 may comprise a plurality of struts 89 connected at junctures 91. A plurality of openings 92 may be positioned between the struts 89. The openings 92 may be configured to reduce the overall weight of the frame 86, and also allow the frame 86 to be compressed to reduce a diameter of the frame 86 and be expanded to increase a diameter of the frame 86. The frame 86 may be configured to be radially compressed and axially lengthened while being radially compressed. The struts 89 may be configured such that as the frame 86 is compressed to reduce a diameter of the frame 86, the length of the frame 86 may increase. Also, as the frame 86 is expanded to increase the diameter of the frame 86, the length of the frame 86 may decrease. The frame 86 may be compressed in a variety of manners, including use of a crimping device, and may be expanded in a variety of manners, including being expanded with a balloon as disclosed herein.

[0064] The configuration of the implant shown in FIGS. 23-25 may be varied in examples.

[0065] Referring back to FIG. 4, in examples in which the balloon 10 has a tapered shape, benefits may result for the crimped profile of an implant that is positioned at the implant retention area 70 and may include other benefits such as improved flow of inflation fluid to inflate the balloon 10 and dilate an implant positioned upon the implant retention area 70 of the balloon 10.

[0066] For example, FIG. 5 illustrates a chart of a crimped outer diameter of an implant, such as the implant shown in FIGS. 23-25 upon a variety of different types of balloons (including a tapered balloon). The Y-axis shows outer diameter in millimeters and the X-axis shows a position along the implant. Upon an implant being crimped to a non-tapered balloon, whether the balloon is made of a material such as Grilamid L25 or polyethylene terephthalate (PET), the inflow side or distal end of the implant including a skirt has a larger diameter than the outflow side or proximal end of the implant. This is because the skirt, such as the skirt 90 shown in FIG. 23, has increased bulk relative to the frame 86 alone, and increases the diameter at the inflow or distal side of the implant. A tapered balloon as shown in FIGS. 1 and 2, for example, may have increased material and diameter at the outflow or proximal side of the implant even in a deflated state, thus resulting in an implant with a linear outer diameter along the length of the implant, as shown in the dashed lines in FIG. 5, upon being crimped to the balloon.

[0067] A benefit to a tapered shape may further include improved flow of inflation fluid to inflate the balloon 10 and dilate an implant positioned upon the implant retention area 70 of the balloon 10. The balloon 10, having a tapered profile as shown in FIG. 2, may allow for enhanced flow of fluid from the proximal portion or first end portion 16 in a direction towards the second end portion 18, or distal portion as shown in FIG. 2 during inflation. The enhanced flow of fluid may be caused by a larger diameter of the interior chamber 34 at the proximal or first end portion 16 of the balloon 10 shown in FIG. 2, thus allowing for enhanced fluid flow to the second end portion 18 or distal end portion shown in FIG. 2.

[0068] The enhanced flow of fluid may allow for more symmetric inflation of the balloon 10 and deployment of the implant at both the first end 82 and the second end 84 of the implant. FIG. 20, for example, illustrates the balloon 10 being inflated in which the first end portion 16 of the balloon 10 and the second end portion 18 of the balloon 10 both inflate at a similar rate, to form a dumbbell shape for the balloon 10. The implant 80 positioned between the ends of the dumbbell deploys with a bowed shape, at both ends 82, 84 of the implant 80. As such, the implant 80 has a reduced possibility of slipping longitudinally along the outer surface of the balloon 10 and possibly being misdeployed during inflation of the balloon 10, due to the larger size of the ends 16, 18 of the balloon 10 and a symmetrical inflation of the ends 16, 18. The ends 16, 18 may inflate at a similar rate at a similar time, to impede a longitudinal sliding movement of the implant 80. The ends 16, 18 may inflate at a similar rate at a similar time due to the enhanced How of fluid from the proximal portion or first end portion 16 in a direction towards the second end portion 18, or distal portion as shown in FIG. 2 during inflation. Use of a tapered balloon may produce other benefits in examples.

[0069] In other examples herein, however, balloons disclosed herein may lack a taper and may have a cylindrical shape or another shape as desired.

[0070] The balloon 10 may have a composition that may provide a variety of benefits, including enhancing the ability of the balloon 10 to retain a tapered profile. For example, referring to FIG. 2, the wall 14 may include a first layer 100 (or inner layer 100) and a second layer 102 (or outer layer 102) that is positioned adjacent to the first layer 100 and is not thermally bondable to the first layer 100. The second layer 102 may be incompatible or immiscible with the first layer 100. The first layer 100 may be positioned radially inward of the second layer 102 in examples, and may comprise the inner surface 32 of the wall 14 in examples. The second layer 102 may be positioned radially outward of the first layer 100 and in examples may comprise the outer surface 30 of the wall 14 in examples.

[0071] The first layer 100 may be configured to be thermally bonded to the elongate shaft 52 of the delivery catheter 50 in examples. The first layer 100, for example, may comprise a polyamide or a co-polyamide or another material as desired. The first layer 100, for example, may comprise nylon, such as nylon 12, or a material such as Pebax ® or Grilamid L25. The first layer 100 may comprise an aliphatic polyamide, an aromatic polyamide, a polyamide 12, a polyamide 11, or a copolyamide, or other materials. The first layer 100 may have a Shore durometer greater than 65D, in examples. The elongate shaft 52 of the delivery catheter 50 may be made of the same or similar material as the first layer 100, such that the elongate shaft 52 is thermally bonded to the first layer 100. The thermal bonding may couple the first layer 100 to the elongate shaft 52. Other materials may be utilized for the first layer 100 as desired.

[0072] The second layer 102 may be configured to be thermally non-bondable with the first layer 100 and the elongate shaft 52 of the delivery catheter in examples. The second layer 102, for example, may comprise a polyester or a co-polyester or another material as desired. The second layer 102, for example, may comprise a polyethylene terephthalate (PET), a polyethylene terephthalate glycol (PETG), a polybutylene terephthalate (PBT) or a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof in examples. Other materials may be utilized for the second layer 102 as desired.

[0073] The first layer 100 and second layer 102 being thermally non-bondable may allow the layers to separate from each other if the wall 14 were cut and the layers 100, 102 were pulled from each other. The first layer 100 may extend over the second layer 102 during the formation process of the wall 14, yet may remain thermally non-bondable to the second layer 102.

[0074] The presence of the second layer 102 may provide additional burst pressure and tear resistance. Further, puncture resistance may be provided due to the presence of the second layer 102.

[0075] The overall thickness of the second layer 102 may comprise 25 percent to 75 percent of the total wall 14 thickness in examples, although other configurations may be utilized as desired.

[0076] A compliance of the balloon 10 is an increase in diameter of the balloon 10 with pressure. The second layer 102 may comprise a material that has less compliance than the first layer 100. The first layer 100, for example, may comprise a semi-compliant material and the second layer 102 may comprise a low compliance material, although other configurations may be utilized as desired. In examples, a burst pressure of the balloon 10 may be at least about 7.5 atmospheres. Other configurations of the balloon 10 may be utilized as desired.

[0077] The taper of the central portion 20 in examples may be a difference in the diameter 35 at the distal end of the central portion 20 (marked in FIG. 2) to the diameter 33 at the proximal end of the central portion 20 (marked in FIG. 2) of at least 1 millimeter, or in examples, at most 3 millimeters at a nominal inflation pressure of 4 atmospheres. The taper may be in a range between 1 millimeter and 3 millimeters in examples at a nominal inflation pressure of 4 atmospheres. Other dimensions may be utilized in examples as desired.

[0078] The use of a relatively low compliance material (for example, the material of the second layer 102) may enhance the strength of the balloon 10, thus allowing the balloon 10 to retain a tapered shape as disclosed herein. The structure and features of the balloon 10 disclosed herein, however, may be utilized with another shape of balloon, such as a cylindrical balloon or other shape in examples as desired.

[0079] The wall 14 of the balloon 10 in examples may be formed by the layers 100, 102 and a third layer (or outer layer) being co-extruded and molded (or blow molded) and by the third layer being removed such that the first layer 100 and the second layer 102 remain. Blow molding may include biaxially stretching the wall 14 in examples. For example, the blow molding may include pressuring the wall 14 to stretch the wall 14 radially while stretching the wall 14 axially. Such a formation process may provide benefits resulting from the configuration of the second layer 102. For example, such a process may align the molecules of the second layer 102 material to enhance strength in the radial dimension (indicated in FIG. 2 with reference number 28) relative to an axial dimension along the longitudinal axis 26.

[0080] The tear strength for the wall 14 in the axial dimension accordingly may be weaker than in the radial dimension. For example, the tear strength of the wall 14 in the radial dimension may be at least 20 percent higher than the tear strength of the wall 14 in the axial dimension, although other configurations may be utilized as desired. Such a feature may be desirable in the event of an accidental burst of the balloon 10. If the tear strength of the wall 14 in an axial direction is weaker than the tear strength of the wall 14 in a radial direction then the wall 14 is more likely to tear longitudinally. A longitudinal tear may be desirable over a radial tear because a radial tear may impede the ability of the burst balloon to be retracted into a catheter sheath for removal from the patient’ s body. For example, a radial tear may form an umbrella or tented shape with a large diameter that may not fit into a smaller diameter catheter sheath for retrieval. As such, a longitudinal tear in the case of an accidental burst may be desirable for retrieval of an accidentally burst balloon.

[0081] FIGS. 6-12 illustrate exemplary process steps of manufacturing the wall 14. Steps of the process may be varied, substituted, excluded, added to, or otherwise modified as desired. FIG. 6, for example, illustrates a cross sectional view of a first extruder 110, a second extruder 112, and a third extruder 114. The extruders 110, 112, 114 may produce materials providing the respective first layer 100, the second layer 102, and a third layer 104, in a molten state to a crosshead 120. In examples, the materials of the first layer 100 and the third layer 104 may be provided in a molten state to the crosshead 120 by a single extruder.

[0082] The crosshead 120 may co-extrude the layers 100, 102, 104 such that the resulting first layer 100 may be positioned adjacent to and radially inward of the second layer 102, the second layer 102 may be positioned adjacent to and radially outward of the first layer 100, and the third layer 104 may be positioned adjacent to and radially outward of the second layer 102. The crosshead 120 may include an extrusion die 122 that may be shaped to result in the shape of an elongate tube 130 as shown in FIG. 7. The crosshead 120 and die 122 may co-extrude the layers 100, 102, 104 and in examples a cutter 124 may cut the co-extruded layers 100, 102, 104 in determined lengths (e.g., 15 inches) to form the elongate tube 130. In examples, three or more molten thermoplastics may be co-extruded to form the elongate tube 130. [0083] FIG. 7 illustrates the resulting elongate tube 130 having a wall 107 including the layers 100, 102, 104. The third layer 104 may form an outer surface 131 of the elongate tube 130. The third layer 104 may be configured to be thermally non-bondable with the second layer 102. The third layer 104, for example, may comprise a polyamide or a co-polyamide or another material as desired. The third layer 104, for example, may comprise nylon, such as nylon 12, or a material such as Pebax® or Grilamid L25. The third layer 104 may comprise an aliphatic polyamide, an aromatic polyamide, a polyamide 12, a polyamide 11, or a co-polyamide, or other materials. The third layer 104 may have a Shore durometer of greater than 65D, in examples.

[0084] To form a 29 millimeter diameter balloon, the elongate tube 130, for example, may have an inner diameter 128 of about 0.217 inches. The first layer 100, for example, may have a thickness of about 0.009 +/- .001 inches. The second layer 102, for example, may have a thickness of about 0.025 +/- .001 inches. The third layer 104, for example, may have a thickness of about 0.003 +/- .001 inches. In examples, the second layer may comprise 50 percent to 75 percent of a thickness of the wall of the elongate tube 130. In examples, the third layer may comprise 5 percent to 15 percent of a thickness of the wall of the elongate tube 130. Other dimensions may be utilized in examples as desired.

[0085] The elongate tube 130 may include a first end portion 132 and a second end portion 134 opposite the first end portion 132. The elongate tube 130 may include a central portion 133 between the first end portion 132 and the second end portion 134. The end portions 132, 134 of the elongate tube 130 may be heated (e.g., by convection heating) to about 275 +/- 50 degrees Fahrenheit for about 60 +/- 30 seconds. In processes disclosed herein, the elongate tube 130 may be heated to a temperature that is between 230 degrees Fahrenheit and 315 degrees Fahrenheit (although other ranges may be utilized as desired). Once the end portions 132, 134 are heated, the end portions 132, 134 may be stretched axially such that an outer diameter 127 of the end portions 132', 134' (with the prime ¹ indicating the axially stretched state) (marked in FIG. 8) is less than an outer diameter 125 of the central portion 133, in examples. The outer diameter 125 may result from a configuration of the crosshead 120 (marked in FIG. 6) and/or the die 122 (marked in FIG. 6). In examples, the end portions 132', 134' may each be stretched at about 100 +/- 10 millimeters per second (mm/sec) for about 220 +/- 25 millimeters. The central portion 133 may have the outer diameter 125 along a length 138 of about 34 +/- 5 millimeters, in examples. Other dimensions and stretch rates may be utilized in examples as desired. The resulting elongate tube 130' as shown in FIG. 8 may be referred to as a parison.

[0086] The elongate tube 130' may be heated within a mold 150 (marked in FIG. 9). In examples, the end portions 132 , 134 of the elongate tube 130' may be cooled for at least about 35 seconds before the elongate tube 130' is heated (e.g., by convection heating) to about 250 +/- 20 degrees Fahrenheit for about 210 +/- 50 seconds, in examples. Other methods may be utilized in examples.

[0087] The elongate tube 130 ' may be blow molded within the mold 150 to form a molded elongate tube 152 (also may be referred to as a blow molded elongate tube 152) or balloon as shown in FIG. 9. The mold 150 may comprise a blow mold. The blow molding may comprise pressurizing the wall 107 by about 8 +/- 3 atmospheres to radially stretch the wall 107 within the mold 150 to form the molded elongate tube 152 having the stretched wall 107. The elongate tube 130' or the central portion 133, for example, may be radially stretched about 3x an original outer diameter of the elongate tube 130 (e.g., an outer diameter 154 may be about 3x the outer diameter 125). The blow molding may further comprise axially stretching the wall 107 about 30 +/- 5 millimeters by applying about 65 +/- 20 pounds of force to each of the end portions 132', 134'. The elongate tube 130' , for example, may be axially stretched about 3x an original length of the elongate tube 130 or the central portion 133 (e.g., the length 138). In examples, the blow molding may further comprise heating (e.g., by convection heating) the elongate tube 130' to about 285 +/- 30 degrees Fahrenheit while the wall 107 is being radially stretched and axially stretched.

[0088] The mold 150, for example, may have an internal diameter of about 28.7 +/- 1 millimeters and a working length of about 38 +/- 1 millimeters such that after blow molding the elongate tube 130', the resulting molded elongate tube 152, for example, may have a 29 +/- 2 millimeters nominal diameter at 4 atmospheres, a wall 107 thickness of about 60 +/- 15 microns, and a working length of about 30 millimeters. Other dimensions may be utilized in examples as desired. In examples, the mold 150 may be configured such that the molded elongate tube 152 has a tapered profile as described herein. A molded elongate tube 152 having a tapered profile may result in a balloon having a tapered profile (e.g., a balloon 10 as shown in FIG. 1).

[0089] The molded elongate tube 152 may be heat set in the mold 150 at about 300 +/- 50 degrees Fahrenheit for about 25 +/- 15 seconds, in examples.

[0090] FIGS. 10-12 illustrate an exemplary process of removing the third layer 104 from the molded elongate tube 152. The process may be varied in examples. In examples, the third layer 104 may be removed from the molded elongate tube 152 to form the wall 14 (marked in FIGS. 2 and 12). The third layer 104 and the second layer 102 being thermally non-bondable may allow the layers to easily separate from each other. In examples, removing the third layer 104 may comprise cutting or scoring the third layer 104. For example, the third layer 104 may be cut or scored at or near the first end portion 132' and/or the second end portion 134' to avoid damaging the second layer 102 or specifically the second layer 102 at or near the central portion 133 '. In examples, a first cut or score 160 may be about 180 degrees apart from a second cut or score 162 as shown in FIG. 10. The third layer 104 may then be removed from (e.g., by being peeled off) the molded elongate tube 152 exposing the second layer 102 as shown in FIG. 11. The third layer 104 may be completely removed from the molded elongate tube 152 as shown in FIG. 12 to form a balloon 164 having the wall 14. The balloon 164 may include the features described herein regarding the balloon 10, yet may have a non-tapered (or cylindrical) shape. In examples, a balloon 10 that is tapered may result from the processes disclosed regarding producing the balloon 164.

[0091] The presence of the third layer 104 during manufacture of the wall 14, specifically during the molding manufacture steps, has benefits, among others, of insulating the second layer 102 from heat thereby reducing or preventing crystallization of the second layer 102. The third layer 104 may comprise an insulation layer. Polyesters (e.g., PET, PETG, and PBT) or copolyesters (e.g., Hytrel®) may be prone to cold crystallization during the blow molding process due to heat, particularly when the polyesters or co-polyesters form an outer layer of a balloon being blow molded. However, an insulating outer layer comprising a material that is thermally non-bondable to a polyester or co-polyester, such as the third layer 104, prevents a polyester or co-polyester layer radially inward of the insulating outer layer, such as the second layer 102, from crystallizing during a blow molding process. Once the blow molding process is complete, the third layer 104 may be removed such that the third layer 104 may be a sacrificial layer. The resulting balloon 164 (or balloon 10) may include the resulting wall 14.

[0092] Removing the third layer 104 may have the benefit of reducing a total wall 14 thickness of the balloon 10 (or balloon 164). For example, a balloon 10, 164 configured as a 29 millimeter diameter balloon and having the wall 14 may have a total wall 14 thickness (e.g., about 51 microns) that is about 80% of a total wall thickness of a similar balloon (e.g., another 29 millimeter balloon) having a single layered wall comprising nylon 12, with both balloons having similar burst pressures (e.g., about 10.56 atmospheres).

[0093] Removing the third layer 104 may have the additional benefit of having a polyester or co-polyester comprise the outer surface 30 (marked in FIGS. 1 and 2) of the balloon 10, 164. For example, PET and PETG have a higher tensile strength and puncture resistance than a polyamide (e.g., polyamide 12) or co-polyamide at the same wall thickness. Moreover, an outer layer comprising, for example, PET or PETG provides a balloon desirable axial burst characteristics.

[0094] Once the third layer 104 has been removed, the balloon 164 (or balloon 10) in examples may be annealed at about 149 +/- 59 degrees Fahrenheit for about 2 +/- 1.5 hours. [0095] Further, the first layer 100 of the balloon 164 (or balloon 10) may be thermally bonded to the elongate shaft 52 of the delivery catheter 50 in examples (marked in FIG. 3) as previously described herein.

[0096] In examples, a crimping device may be utilized to crimp an implant to the balloon 10, 164. The crimping device may be for an implant for implantation within a portion of the patient’s body. The implant, for example, may be configured similarly as the implant 80 shown in FIGS. 23-25, although other configurations may be utilized as desired. The crimping device may be utilized to crimp an implant to a balloon that has a tapered profile, similar to the balloon 10 shown in FIG. 2 for example.

[0097] FIG. 19 for example, illustrates the implant 80 crimped to the balloon 10 with the skirt 90 positioned at the larger diameter 33 of the tapered balloon 10. The taper of the balloon may yet allow the implant 80 to be deployed with a bowed shape as shown in FIG. 20 for example. FIG. 20 illustrates the balloon 10 partially inflated. The presence of the first end portion 16 and the second end portion 18 of the balloon 10 may allow the implant 80 to remain positioned between the end portions 16, 18 and not slip off of the balloon 10 longitudinally or otherwise be undesirably displaced during deployment of the implant 80. The larger end portions 16, 18 positioned adjacent a narrower central portion 20 may impede the longitudinal movement of the implant 80, to allow for a more precise and predictable deployment position of the implant 80. The balloon 10 for example, may have a dumbbell or hourglass shape during deployment, as shown in FIG. 20.

[0098] FIGS. 21 and 22 illustrate an exemplary operation of deploying the implant 80 in the form of a prosthetic heart valve. The balloon 10 and the elongate shaft 52 of the delivery catheter 50 may be inserted into a patient’s body. The insertion may be transvascular in examples, and may be via a femoral entry, or other forms of entry in examples. The balloon 10 and elongate shaft 52 may travel over the aortic arch in examples, although other approaches (e.g., transapical, transseptal, among others) may be utilized.

[0099] The implant 80 for example, may be positioned at the inflation site, which may be an aortic valve 140 as shown herein, or another location as desired. The balloon 10 may be expanded through pressure applied to the inner surface of the wall of the balloon to expand the implant at the portion of the patient’s body comprising the inflation site or implantation site. The inflation site or implantation site may comprise a heart valve, although other inflation or implantation sites may be utilized as desired.

[0100] FIG. 22 illustrates the balloon 10 being inflated. The implant 80 is expanded upon the balloon 10 and deployed to the implantation site. The balloon 10 may then be deflated and withdrawn from the patient’ s body with the implant 80 remaining in position. The implant 80 may be delivered to the implantation site upon the balloon 10 in examples, or may be advanced to the implantation site and then slid onto the balloon 10 for deployment in examples.

[0101] The implantation may be to a native valve or may be to another prior deployed prosthetic valve. For example, the balloon 10 may be utilized in a valve-in- valve procedure in which the implant 80 is deployed within a previously deployed prosthetic valve.

[0102] The balloon 10 may be configured to dilate an expandable implant positioned upon the wall of the balloon in examples, or may be configured to dilate another surface within the patient’s body. For example, the balloon 10 may be utilized for dilation of surfaces of a structure such as native heart valve leaflets prior to implantation of the implant 80, or may be utilized for dilation of surfaces of vessels or other surfaces within the patient’s body. The expandable implant may comprise a prosthetic heart valve in examples. The balloon 164 may be utilized in a similar manner as the balloon 10.

[0103] Various configurations of the balloons may be utilized as desired. The composition of a balloon disclosed herein may be utilized with a tapered balloon (such as balloon 10), or another form of balloon such as a cylindrical balloon as desired (such as balloon 164). Other shapes of balloons may be utilized. Components of systems disclosed herein may be utilized separately as desired.

[0104] The features disclosed in regard to FIGS. 1-12 may be utilized solely or in combination with other examples herein. Other examples of balloons may be utilized in examples.

[0105] FIG. 13 illustrates an example of a balloon 210 that may be utilized according to examples herein. The balloon 210 may include a wall 214. The wall 214 may have an inner surface 242 and the balloon 210 may be expandable through pressure applied to the inner surface 242 of the wall 214.

[0106] The balloon 210 may be configured similarly as the balloon 10 shown in FIG. 2 unless stated otherwise, and may include a first end portion 246, a second end portion 248 and a central portion 244 positioned between the first end portion 246 and the second end portion 248. The end portions 246, 248 may be tapered in a similar manner as the respective end portions 16, 18, or may have another configuration as desired. The central portion 244 may have a tapered profile as shown in FIG. 13, or may have a cylindrical shape or other shape as desired. The balloon 210, for example, may have a cylindrical shape as disclosed herein. The central portion 244 may have a length 249 between the ends of the central portion 244. [0107] A nose cone 24 may be positioned at the end of the balloon 210 in examples, although a nose cone may not be utilized in certain examples.

[0108] The balloon 210 may have an elongate shape that extends along a longitudinal axis 26 and may be symmetrical about the axis 26. The balloon 210 may be positioned radially outward from the longitudinal axis 26 and thus extends in a radial dimension 28 outward from the longitudinal axis 26.

[0109] The wall 214 may have an outer surface 231 that is configured to apply a force to an implant or another surface to dilate such surface, as described with regard to the balloon 10. The balloon 210 may be configured for an implant to be positioned upon.

[0110] The balloon 210 in examples may be coupled to an elongate shaft of a delivery catheter in a similar manner as the balloon 10. In examples, the balloon 210 may be coupled to another form of device.

[0111] The wall 214 may include a first layer 200 (or inner layer 200), a second layer 202 (or intermediate layer 202), and a third layer 204 (or outer layer 204). The first layer 200 may be positioned radially inward of the second layer 202 in examples and may form the inner surface 242 of the wall 214 in examples. The second layer 202 may be positioned radially outward of the first layer 200 and may be positioned between the first layer 200 and the third layer 204. The third layer 204 may be positioned radially outward of the first layer 200 and the second layer 202 in examples and may comprise the outer surface 231 of the balloon 210 in examples.

[0112] The first layer 200 may be configured to be thermally bonded to the elongate shaft 52 of the delivery catheter 50 (marked in FIG. 3) in examples. The first layer 200, for example, may comprise a polyamide or a co-polyamide or another material as desired. The first layer 200, for example, may comprise nylon, such as nylon 12, nylon 11, nylon 6, or nylon 6/6, or a material such as Pebax® or Grilamid L25. The first layer 200 may comprise an aliphatic polyamide, an aromatic polyamide, a polyamide 12 (such as Grilamid L25), a polyamide 6, a polyamide 11, or a co-polyamide such as a block copolymer having a polyamide 12 segment (such as Pebax® 7233), a polyamide 6 segment (such as Ultramid® B), or a polyamide 6/6 segment (such as Ultramid® A), or other materials. The first layer 200 may have a Shore durometer of at least 63D, in examples. The elongate shaft 52 (marked in FIG. 3) of the delivery catheter 50 may be made of a same or similar material as the first layer 200, such that the elongate shaft 52 is thermally bonded to the first layer 200. The thermal bonding may couple the first layer 200 to the elongate shaft 52. Other materials may be utilized for the first layer 200 as desired.

[0113] The second layer 202 may be configured to be thermally bondable with the first layer 200 and the third layer 204 in examples. The second layer 202 may be configured to couple the first layer 200 to the third layer 204. The second layer 202 may comprise a tie layer. The second layer 202 may be configured in examples to be an adhesive layer. The second layer 202, for example, may comprise a copolymer having a polyether segment and a polyamide segment (such as Pebax®). In examples, the polyether segment may be a soft segment and the polyamide segment may be a hard segment. The second layer 202, for example, may comprise a polyether segment such as a poly tetramethylene glycol (PTMG), a poly tetramethylene oxide (PTMO), a polyethylene glycol (PEG), or a polyethylene oxide (PEO) and a polyamide segment such as a polyamide 12 (such as laurolactam) or polyamide 6 (such as Caprolactam), or combinations thereof in examples. Other materials may be utilized for the second layer 202 as desired.

[0114] The third layer 204 may comprise the outer surface 231 of the balloon 210 in examples. The third layer 204, for example, may be made of a polyester or a co-polyester or another material as desired. The third layer 204, for example, may comprise a polyethylene terephthalate (PET), a polyethylene terephthalate glycol (PETG), a polybutylene terephthalate (PBT) or a thermoplastic elastomer co-polyester such as a block copolymer of PBT and poly ether (such as Hytrel®), or combinations thereof in examples. The block copolymer may have a polybutylene terephthalate segment and a polyether segment. The third layer 204 may be made of a material that is thermally non-bondable with the first layer 200, yet is bonded or coupled to the first layer 200 due to the presence of the second intermediate layer 202. The presence of the third layer 204, for example, may provide a higher burst pressure of at least about 9.15 atmospheres in examples and increased puncture resistance in examples. Other configurations may be utilized as desired.

[0115] To couple the first layer 200 to the third layer 204, the second layer 202 may be configured such that a number of carbon atoms in a polyether block monomer of the second layer 202 is equal to a number of carbon atoms in a polyether monomer of the third layer 204 and a number of carbon atoms in a polyamide block monomer of the second layer 202 is equal to a number of carbon atoms in a polyamide monomer of the first layer 200. For example, in one example the first layer 200 may comprise a polyamide or co-polyamide having twelve carbon atoms in a monomer of the polyamide or co-polyamide (such as polyamide 12 or Pebax® 7233), the second layer 202 may comprise a copolymer having two carbon atoms in a polyether block monomer (such as PEO) and twelve carbon atoms in a polyamide block monomer (such as laurolactum), and the third layer 204 may comprise a polyester or co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or co-polyester (such as PET).

[0116] In another example the first layer 200 may comprise a polyamide or co-polyamide having twelve carbon atoms in a monomer of the polyamide or co-polyamide (such as polyamide 12 or Pebax® 7233), the second layer 202 may comprise a copolymer having four carbon atoms in a polyether block monomer (such as PTMO) and twelve carbon atoms in a polyamide block monomer (such as laurolactum), and the third layer 204 may comprise a polyester or co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or co-polyester (such as PBT or Hytrel® 7246).

[0117] In another example the first layer 200 may comprise a polyamide or co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide (such as polyamide 6 or Ultramid® B), the second layer 202 may comprise a copolymer having two carbon atoms in a polyether block monomer (such as PEO) and six carbon atoms in a polyamide block monomer (such as caprolactam), and the third layer 204 may comprise a polyester or co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or co-polyester (such as PET).

[0118] In another example the first layer 200 may comprise a polyamide or co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide (such as polyamide 6 or Ultramid® B), the second layer 202 may comprise a copolymer having four carbon atoms in a polyether block monomer (such as PTMO) and six carbon atoms in a polyamide block monomer (such as caprolactam), and the third layer 204 may comprise a polyester or co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or co-polyester (such as PBT or Hytrel® 7246).

[0119] In another example the first layer 200 may comprise a polyamide or co-polyamide having six carbon atoms in one or more (e.g., two) monomers of the polyamide or co-polyamide (such as polyamide 6, polyamide 6/6, or Ultramid® A), the second layer 202 may comprise a copolymer having two carbon atoms in a polyether block monomer (such as PEO) and six carbon atoms in a polyamide block monomer, and the third layer 204 may comprise a polyester or co- polyester having two carbon atoms in a monomer of an ether segment of the polyester or co- polyester (such as PET).

[0120] In another example the first layer 200 may comprise a polyamide or co-polyamide having six carbon atoms in one or more (e.g., two) monomers of the polyamide or co-polyamide (such as polyamide 6, polyamide 6/6, or Ultramid® A), the second layer 202 may comprise a copolymer having four carbon atoms in a polyether block monomer (such as PTMO) and six carbon atoms in a polyamide block monomer, and the third layer 204 may comprise a polyester or co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or co-polyester (such as PBT or Hytrel® 7246). [0121] Other configurations of the first layer 200, the second layer 202, and the third layer

204 may be utilized as desired.

[0122] The second layer 202 being thermally bondable to the first layer 200 and the third layer 204 may prevent the layers from separating from each other if the wall 214 were cut. In addition, the second layer 202 may prevent the first layer 200 or the third layer 204 from bursting during formation of the balloon 210, such as during blow molding or use of the balloon 210.

[0123] The overall thickness of the first layer 200 may comprise 10 percent to 50 percent of the total wall 214 thickness in examples. The overall thickness of the second layer 202 may comprise 1 percent to 10 percent of the total wall 214 thickness in examples. The overall thickness of the third layer 204 may comprise 40 percent to 80 percent of the total wall 214 thickness in examples. The balloon 210, for example, may have a total wall 214 thickness of between about 59 microns to about 65 microns. The balloon 210, for example, may have a total wall 214 thickness of at least about 45 microns or about 50 microns, in examples. However, other configurations may be utilized to achieve a desired compliance or characteristic of the balloon 210.

[0124] A compliance of the balloon 210 is an increase in diameter of the balloon 210 with pressure. The third layer 204 may comprise a material that has less compliance than the first layer 200. The first layer 200, for example, may comprise a semi-compliant material and the third layer 204 may comprise a low compliance material, although other configurations may be utilized as desired.

[0125] A balloon 210 as disclosed herein may have an outer diameter compliance between 0.30 millimeters per atmosphere (mm/atm) and 0.42 millimeters per atmosphere (mm/atm). The compliance may be in a range between four atmospheres to eight atmospheres applied to the balloon 210 in examples. A balloon 210 as disclosed herein may have a normalized compliance (which is compliance in millimeters per atmosphere per balloon outer diameter in millimeters) of between 10 percent to 25 percent. In examples, the wall 214 may have an outer diameter compliance of between 10 percent growth per atmosphere and 16 percent growth per atmosphere between 4 atmospheres to 8 atmospheres when normalized by a diameter of the balloon 210. Other values of compliance may be utilized in examples as desired.

[0126] In examples, at 4 atmospheres the balloon 210 may have an outer diameter of at least about 10 millimeters or at least about 15 millimeters in examples.

[0127] In examples, a burst pressure of the balloon 210 may be at least about 7.5 atmospheres. In examples, a burst pressure of the balloon 210 may be between about 9.5 atmospheres and about 11.5 atmospheres. In examples, the wall 214 may have a hoop strength (which is burst pressure times diameter divided by twice the thickness) of at least 22,000 pounds per square inch or at least 24,000 pounds per square inch in examples. Other configurations of the balloon 210 may be utilized as desired.

[0128] The wall 214 may be formed by blow molding and biaxial stretching (pressure and axial stretching). The tapered portions of the wall 214 may be formed by taper stretching.

[0129] FIGS. 14-17 illustrate exemplary process steps of manufacturing the wall 214. Steps of the process may be varied, substituted, excluded, added to, or otherwise modified as desired. FIG. 14, for example, illustrates a cross sectional view of a first extruder 211, a second extruder 212, and a third extruder 215 providing the first layer 200, the second layer 202, and the third layer 204, respectively, in a molten state to a crosshead 220. The crosshead 220 may coextrude the layers 200, 202, 204 such that the first layer 200 may be positioned adjacent to and radially inward of the second layer 202, the second layer 202 may be positioned adjacent to and radially outward of the first layer 200, and the third layer 204 may be positioned adjacent to and radially outward of the second layer 202. In examples, the crosshead 220 may co-extrude the layers 200, 202, 204 and a sacrificial outer layer as described herein with regard to the balloons 10, 164. The crosshead 220 may include an extrusion die 222 that may be shaped to result in the shape of an elongate tube 230 as shown in FIG. 15. The crosshead 220 and die 222 may coextrude the layers 200, 202, 204 and in examples a cutter 224 may cut the co-extruded layers 200, 202, 204 in determined lengths (e.g., 15 inches) to form the elongate tube 230.

[0130] The second layer 202 may be configured to thermally bond to the first layer 200 and the third layer 204 during the co-extrusion process in examples.

[0131] FIG. 15 illustrates the resulting elongate tube 230 having a wall 217 including the layers 200, 202, 204. The third layer 204 may form an outer surface 235 of the elongate tube 230. The third layer 204 may be coupled to the first layer 200 by the second layer 202.

[0132] For example, to form a 29 millimeter diameter balloon, the elongate tube 230, for example, may have an inner diameter 228 of about 0.218 inches and a total wall 217 thickness of about 0.035 inches. The first layer 200, for example, may have a thickness of about 0.012 +/- .001 inches. The second layer 202, for example, may have a thickness of about 0.002 +/- .001 inches. The third layer 204, for example, may have a thickness of about 0.020 +/- .001 inches. Other dimensions may be utilized in examples as desired.

[0133] The elongate tube 230 may include a first end portion 232 and a second end portion 234 opposite the first end portion 232. The elongate tube 230 may include a central portion 233 between the first end portion 232 and the second end portion 234. The end portions 232, 234 of the elongate tube 230 may be heated (e.g., by convection heating) to about 275 +/- 50 degrees Fahrenheit for 60 +/- 30 seconds. Further, the end portions 232, 234 may be stretched axially such that an outer diameter 227 of the stretched end portions 232 ' , 234' (with the prime ¹ indicating the axially stretched state) is less than an outer diameter 225 of the central portion 233 as shown in FIG. 16. The outer diameter 225 may result from a configuration of the crosshead 220 (marked in FIG. 14) and/or the die 222 (marked in FIG. 14). In examples, the end portions 232 ', 234' may each be stretched at about 100 +/- 10 millimeters per second (mm/sec) for about 220 +/- 25 millimeters. The central portion 233 may have the outer diameter 225 along a length 238 of about 34 +/- 5 millimeters. Other dimensions and stretch rates may be utilized in examples as desired. The resulting elongate tube 230' as shown in FIG. 16 may be referred to as a parison.

[0134] Further, the end portions 232 ', 234' of the elongate tube 230' may be cooled for at least about 35 seconds before the elongate tube 230' is heated (e.g., by convection heating) to about 250 +/- 20 degrees Fahrenheit for about 210 +/- 50 seconds. For example, the elongate tube 230' may be heated within a mold 250 (marked in FIG. 17). Further, the elongate tube 230' may be blow molded within the mold 250 to form a molded elongate tube 252 (also may be referred to as a blow molded elongate tube 252) or balloon having the wall 217 as shown in FIG. 17. The blow molding may comprise pressurizing the wall 217 by about 8 +/- 3 atmospheres to stretch the wall 217 radially. The elongate tube 230' or the central portion 233 ', for example, may be radially stretched about 3x an original outer diameter of the elongate tube 230 (e.g., an outer diameter 254 may be about 3x the outer diameter 225). The blow molding may further comprise axially stretching the wall 217 about 30 +/- 5 millimeters by applying about 65 +/- 20 pounds of force to each of the end portions 232 ' , 234 ' . The elongate tube 230 ' , for example, may be axially stretched about 3x an original length of the elongate tube 230 or the central portion 233 ' (e.g., the length 238). In examples, the blow molding may further comprise heating (e.g., by convection heating) the elongate tube 230' to about 285 +/- 30 degrees Fahrenheit while the wall 217 is being radially stretched and axially stretched.

[0135] The mold 250, for example, may have an internal diameter of about 28.7 +/- 1 millimeters and a working length of about 38 +/- 1 millimeters such that after blow molding the elongate tube 230', the resulting molded elongate tube 252, for example, may have a 29 +/- 2 millimeters nominal diameter at 4 atmospheres, a total wall 217 thickness of about 60 +/- 15 microns, and a working length of about 30 millimeters. Other dimensions may be utilized in examples as desired. In examples, the mold 250 may be configured such that the molded elongate tube 252 has a tapered profile as described herein. [0136] Further, the molded elongate tube 252 may be heat set in the mold 250 at about 300 +/- 50 degrees Fahrenheit for about 25 +/- 15 seconds, in examples. The molded elongate tube 252 may result in the balloon 210.

[0137] The balloon 210, may have a burst pressure of about 11.4 atmospheres. For a 29 millimeter diameter balloon, the balloon 210 may have a total wall 217 thickness of at least about 45 microns and preferably at least about 50 microns. The balloon 210, for example, may have a total wall 217 thickness between about 60 microns to about 64 microns. Other dimensions may be utilized in examples as desired.

[0138] Further, the balloon 210 may be annealed. For example, the balloon 210 may be annealed at about 149 +/- 59 degrees Fahrenheit for about 2 +/- 1 .5 hours. After annealing, the balloon 210, for example, may have a total wall 217 thickness of about 60 +/- 15 microns and a burst pressure of about 9.45 atmospheres. The balloon 210, for example, may have an outer diameter compliance of about 0.364 millimeters per atmosphere (mm/atm). Thus, in examples, the balloon 210 may have an outer diameter compliance that is lower than the 0.464 millimeters per atmosphere (mm/atm) average outer diameter compliance of a balloon having a wall including a single layer comprising polyamide 12 or the 0.403 millimeters per atmosphere (mm/atm) average outer diameter compliance of a balloon having a wall including three nonbonded layers comprising a polyamide 12 first layer, a PET second layer, and a polyamide 12 third layer. The compliance may be in a range between four atmospheres to eight atmospheres applied to the balloon 210 in examples.

[0139] For example, FIG. 18 illustrates a chart of a compliance of a variety of different annealed balloons (e.g., 29 millimeter diameter balloons). The Y-axis shows outer diameter in millimeters and the X-axis shows an inflation pressure of the balloons in atmospheres. FIG. 18 illustrates a balloon 210 having a first layer 200 comprising Grilamid L25, a second layer 202 comprising Pebax®, and a third layer 204 comprising polyethylene terephthalate (PET) with the third layer 204 being coupled to the first layer 200 by the second layer 202, may have similar compliance to a balloon having a first layer comprising Grilamid L25, a second layer comprising polyethylene terephthalate (PET), and a third layer comprising Grilamid L25 with the third layer having a thickness of 0.008 inches and not being coupled to the first layer.

[0140] Referring back to FIG. 17, the first layer 200 of the balloon 210 may be thermally bonded to the elongate shaft 52 of the delivery catheter 50 in examples (marked in FIG. 3).

[0141] The balloon 210 may be utilized with a delivery catheter as disclosed herein, and may be coupled to a distal end portion of an elongate shaft of the delivery catheter. The balloon 210 may be utilized in a similar manner as described with regard to FIGS. 21 and 22, and may be utilized to dilate a surface within a patient’s body, which may comprise an expandable implant as desired. The balloon 210 may be configured to dilate an expandable implant positioned on the wall of the balloon 210. The balloon 210 may be utilized with a crimping device as disclosed herein. The expandable implant may comprise a prosthetic heart valve in examples.

[0142] In examples, the balloons as disclosed herein may be utilized in an angioplasty procedure, or may be utilized for deployment of an implant. Other uses may be provided as desired.

[0143] The features of the examples disclosed herein may be implemented independently or in combination with other features disclosed herein. The various apparatuses of the system may be implemented independently.

[0144] As discussed, various forms of implants may be utilized with the examples disclosed herein, including prosthetic heart valves, or other forms of implants, such as stents or filters, or diagnostic devices, among others. The implants may be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. The implants may be compressible implants configured to be compressed inward to have a reduced outer profile and to move the implant to the compressed or undeployed state.

[0145] The delivery apparatuses as disclosed herein may be utilized for aortic, mitral, tricuspid, and pulmonary replacement and repair as well. The delivery apparatuses may comprise delivery apparatuses for delivery of other forms of implants, such as stents or filters, or diagnostic devices, among others.

[0146] The delivery apparatuses and the systems disclosed herein may be used in transcatheter aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., mitral, tricuspid, or pulmonary). The delivery apparatuses and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient’s heart. The delivery apparatuses and systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized. Other procedures may be utilized as desired.

[0147] Features of examples may be modified, substituted, excluded, or combined across examples as desired.

[0148] In addition, the methods herein are not limited to the methods specifically described, and may include methods of utilizing the systems and apparatuses disclosed herein. The steps of the methods may be modified, excluded, or added to, with systems, apparatuses, and methods disclosed herein. [0149] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. Features, elements, or components of one example can be combined into other examples herein.

[0150] Example 1 : A method of making a balloon for insertion within a portion of a patient’s body, the method comprising: heating an elongate tube having a wall including three or more layers to a first temperature; radially stretching the wall of the elongate tube within a mold to form a molded elongate tube having the stretched wall; and removing a layer of the three or more layers of the stretched wall to form the balloon, the balloon being expandable through pressure applied to an inner surface of the balloon.

[0151] Example 2: The method of any example herein, in particular Example 1, wherein the three or more layers include: a first layer, a second layer positioned adjacent to and radially outward of the first layer, and a third layer positioned adjacent to and radially outward of the second layer, the third layer forming an outer surface of the elongate tube; and removing the layer of the three or more layers of the stretched wall includes removing the third layer from the second layer.

[0152] Example 3: The method of any example herein, in particular Example 2, wherein: the molded elongate tube includes a first end portion, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion; and removing the third layer includes cutting or scoring the first end portion and/or the second end portion to avoid damaging a portion of the second layer that is within the central portion of the molded elongate tube.

[0153] Example 4: The method of any example herein, in particular Example 2 or Example 3, wherein the third layer is made of a material that is not thermally bondable with the second layer.

[0154] Example 5: The method of any example herein, in particular Examples 2-4, wherein: the first layer comprises a polyamide or a co-polyamide; the second layer comprises a polyester or a co-polyester; and the third layer comprises a polyamide or a co-polyamide. [0155] Example 6: The method of any example herein, in particular Examples 2-5, wherein the second layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a thermoplastic elastomer co-polyester, or combinations thereof.

[0156] Example ?: The method of any example herein, in particular Examples 2-6, wherein the second layer comprises 50 percent to 75 percent of a thickness of the wall of the elongate tube.

[0157] Example 8: The method of any example herein, in particular Examples 2-7, wherein the third layer comprises 5 percent to 15 percent of a thickness of the wall of the elongate tube.

[0158] Example 9: The method of any example herein, in particular Examples 1-8, further comprising co-extruding three or more molten thermoplastics to form the elongate tube.

[0159] Example 10: The method of any example herein, in particular Examples 1-9, wherein the first temperature is between 230 degrees Fahrenheit and 315 degrees Fahrenheit.

[0160] Example 11: The method of any example herein, in particular Examples 1-10, wherein: the mold is a blow mold; and radially stretching the wall of the elongate tube in the mold includes blow molding the wall to form the molded elongate tube having the stretched wall.

[0161] Example 12: The method of any example herein, in particular Example 11, wherein the three or more layers include: a first layer, a second layer positioned adjacent to and radially outward of the first layer, and a third layer positioned adjacent to and radially outward of the second layer, the third layer forming an outer surface of the elongate tube; and wherein the third layer insulates the second layer during the blow molding to reduce crystallization of the second layer.

[0162] Example 13: The method of any example herein, in particular Examples 1-12, wherein a burst pressure of the balloon is at least 7.5 atmospheres.

[0163] Example 14: The method of any example herein, in particular Examples 1-13, wherein the balloon is configured to dilate a surface within the patient’s body.

[0164] Example 15: The method of any example herein, in particular Examples 1-14, wherein the balloon is configured to dilate an expandable implant positioned on the balloon.

[0165] Example 16: The method of any example herein, in particular Example 15, wherein the expandable implant is a prosthetic heart valve.

[0166] Example 17: The method of any example herein, in particular Examples 1-16, further comprising coupling the balloon to an elongate shaft of a catheter.

[0167] Example 18: The method of any example herein, in particular Example 17, wherein the elongate shaft includes a fluid lumen for inflating the balloon. [0168] Example 19: The method of any example herein, in particular Example 17 or Example 18, wherein the elongate shaft is flexible to allow for deflection of the elongate shaft.

[0169] Example 20: The method of any example herein, in particular Examples 17-19, wherein the elongate shaft has a distal end portion and a proximal end portion, and the balloon is coupled to the distal end portion, and a handle is coupled to the proximal end portion.

[0170] Example 21: A device for insertion within a portion of a patient’s body, the device comprising: a balloon having a blow molded wall including: an inner surface, a first layer, and a second layer positioned radially outward of the first layer, wherein the balloon is expandable through pressure applied to the inner surface of the blow molded wall, the blow molded wall being formed by: blow molding an elongate tube to form a blow molded elongate tube having the first layer, the second layer, and a third layer positioned radially outward of the second layer, the third layer being an insulation layer to reduce crystallization of the second layer during the blow molding, and removing the third layer from the blow molded elongate tube.

[0171] Example 22: The device of any example herein, in particular Example 21, wherein the third layer of the blow molded elongate tube is positioned adjacent to the second layer of the blow molded elongate tube and made of a material that is not thermally bondable with the second layer.

[0172] Example 23: The device of any example herein, in particular Example 21 or Example 22, wherein the third layer forms an outer surface of the blow molded elongate tube.

[0173] Example 24: The device of any example herein, in particular Examples 21-23, wherein the first layer comprises a polyamide or a co-polyamide.

[0174] Example 25: The device of any example herein, in particular Examples 21-24, wherein the second layer comprises a polyester or a co-polyester.

[0175] Example 26: The device of any example herein, in particular Examples 21-25, wherein the third layer comprises a polyamide or a co-polyamide.

[0176] Example 27: The device of any example herein, in particular Examples 21-26, wherein the second layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a thermoplastic elastomer co-polyester, or combinations thereof.

[0177] Example 28: The device of any example herein, in particular Examples 21-27, wherein: the blow molded elongate tube includes a first end portion, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion; and removing the third layer includes cutting or scoring the first end portion and/or the second end portion to avoid damaging a portion of the second layer that is within the central portion of the blow molded elongate tube. [0178] Example 29: The device of any example herein, in particular Examples 21-28, wherein the second layer comprises 50 percent to 75 percent of a wall thickness of the elongate tube.

[0179] Example 30: The device of any example herein, in particular Examples 21-29, wherein the third layer comprises 5 percent to 15 percent of a wall thickness of the elongate tube.

[0180] Example 31: The device of any example herein, in particular Examples 21-30, wherein the balloon is configured to dilate a surface within the patient’s body.

[0181] Example 32: The device of any example herein, in particular Examples 21-31, wherein the balloon is configured to dilate an expandable implant positioned on the balloon.

[0182] Example 33: The device of any example herein, in particular Examples 21-32, further comprising a catheter having an elongate shaft, wherein the balloon is coupled to the elongate shaft of the catheter.

[0183] Example 34: The device of any example herein, in particular Example 33, wherein the elongate shaft includes a fluid lumen for inflating the balloon.

[0184] Example 35: The device of any example herein, in particular Example 33 or Example 34, wherein the elongate shaft has a distal end portion and a proximal end portion, and the balloon is coupled to the distal end portion, and a handle is coupled to the proximal end portion.

[0185] Example 36: A device for insertion within a portion of a patient’s body, the device comprising: a balloon having a wall including: an inner surface, an inner layer comprising a polyamide or a co-polyamide, an outer layer positioned radially outward of the inner layer and comprising a polyester or a co-polyester, and an intermediate layer positioned between the inner layer and the outer layer and bonding the outer layer to the inner layer, the intermediate layer comprising a copolymer having a polyether segment and a polyamide segment, wherein the balloon is expandable through pressure applied to the inner surface of the wall.

[0186] Example 37: The device of any example herein, in particular Example 36, wherein the inner layer comprises a nylon 6, a nylon 12, or a nylon 6/6.

[0187] Example 38: The device of any example herein, in particular Example 36 or Example 37, wherein the intermediate layer comprises: a polytetramethylene glycol segment, a polyethylene glycol segment, a polytetramethylene oxide segment, or a polyethylene oxide segment; and a polyamide 12 or a polyamide 6 segment.

[0188] Example 39: The device of any example herein, in particular Examples 36-38, wherein the outer layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a block copolymer having a polybutylene terephthalate segment and a polyether segment. [0189] Example 40: The device of any example herein, in particular Examples 36-39, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a block copolymer having two carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0190] Example 41: The device of any example herein, in particular Examples 36-40, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0191] Example 42: The device of any example herein, in particular Examples 36-41, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having two carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0192] Example 43: The device of any example herein, in particular Examples 36-42, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0193] Example 44: The device of any example herein, in particular Examples 36-43, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in one or more monomers of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having two carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0194] Example 45: The device of any example herein, in particular Examples 36-44, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in one or more monomers of the polyamide or the co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester layer having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0195] Example 46: The device of any example herein, in particular Examples 36-45, wherein the inner layer comprises 10 percent to 50 percent of a thickness of the wall.

[0196] Example 47: The device of any example herein, in particular Examples 36-46, wherein the intermediate layer comprises 1 percent to 10 percent of a thickness of the wall.

[0197] Example 48: The device of any example herein, in particular Examples 36-47, wherein the outer layer comprises 40 percent to 80 percent of a thickness of the wall.

[0198] Example 49: The device of any example herein, in particular Examples 36-48, wherein the wall has an outer diameter compliance of between 0.30 millimeters per atmosphere and 0.42 millimeters per atmosphere between 4 atmospheres to 8 atmospheres.

[0199] Example 50: The device of any example herein, in particular Examples 36-49, wherein a burst pressure of the balloon is at least about 7.5 atmospheres.

[0200] Example 51: The device of any example herein, in particular Examples 36-50, wherein the balloon is configured to dilate a surface within the patient’s body.

[0201] Example 52: The device of any example herein, in particular Examples 36-51, wherein the balloon is configured to dilate an expandable implant positioned on the balloon.

[0202] Example 53: The device of any example herein, in particular Examples 36-52, further comprising a catheter having an elongate shaft, wherein the balloon is coupled to the elongate shaft of the catheter.

[0203] Example 54: The device of any example herein, in particular Example 53, wherein the elongate shaft includes a fluid lumen for inflating the balloon.

[0204] Example 55: The device of any example herein, in particular Example 53 or Example 54, wherein the elongate shaft has a distal end portion and a proximal end portion, and the balloon is coupled to the distal end portion, and a handle is coupled to the proximal end portion.

[0205] Example 56: A method of delivering an expandable implant to a portion of a patient’s body, the method comprising: inserting a balloon into the patient’s body, the balloon having a blow molded wall including: an inner surface, a first layer, and a second layer positioned radially outward of the first layer, wherein the balloon is expandable through pressure applied to the inner surface of the blow molded wall, the blow molded wall being formed by: blow molding an elongate tube to form a blow molded elongate tube having the first layer, the second layer, and a third layer positioned radially outward of the second layer, the third layer being an insulation layer to reduce crystallization of the second layer during the blow molding, and removing the third layer from the blow molded elongate tube; and expanding the balloon through pressure applied to the inner surface of the blow molded wall to expand the expandable implant at the portion of the patient’ s body.

[0206] Example 57: The method of any example herein, in particular Example 56, wherein the third layer of the blow molded elongate tube is positioned adjacent to the second layer of the blow molded elongate tube and made of a material that is not thermally bondable with the second layer.

[0207] Example 58: The method of any example herein, in particular Example 56 or Example 57, wherein the third layer forms an outer surface of the blow molded elongate tube.

[0208] Example 59: The method of any example herein, in particular Examples 56-58, wherein the first layer comprises a polyamide or a co-polyamide.

[0209] Example 60: The method of any example herein, in particular Examples 56-59, wherein the second layer comprises a polyester or a co-polyester.

[0210] Example 61 : The method of any example herein, in particular Examples 56-60, wherein the third layer comprises a polyamide or a co-polyamide.

[0211] Example 62: The method of any example herein, in particular Examples 56-61, wherein the second layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a thermoplastic elastomer co-polyester, or combinations thereof.

[0212] Example 63: The method of any example herein, in particular Examples 56-62, wherein: the blow molded elongate tube includes a first end portion, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion; and removing the third layer includes cutting or scoring the first end portion and/or the second end portion to avoid damaging a portion of the second layer that is within the central portion of the blow molded elongate tube.

[0213] Example 64: The method of any example herein, in particular Examples 56-63, wherein the second layer comprises 50 percent to 75 percent of a wall thickness of the elongate tube.

[0214] Example 65: The method of any example herein, in particular Examples 56-64, wherein the third layer comprises 5 percent to 15 percent of a wall thickness of the elongate tube.

[0215] Example 66: The method of any example herein, in particular Examples 56-65, wherein the balloon is configured to dilate a surface within the patient’s body.

[0216] Example 67 : The method of any example herein, in particular Examples 56-66, wherein the balloon is configured to dilate an expandable implant positioned on the balloon. [0217] Example 68: The method of any example herein, in particular Examples 56-67, wherein the balloon is coupled to an elongate shaft of a catheter.

[0218] Example 69: The method of any example herein, in particular Examples 56-68, wherein the expandable implant is a prosthetic heart valve.

[0219] Example 70: The method of any example herein, in particular Examples 56-69, wherein the portion of the patient’ s body is a heart valve.

[0220] Example 71: A method of delivering an expandable implant to a portion of a patient’s body, the method comprising: inserting a balloon into the patient’s body, the balloon having a wall including: an inner surface, an inner layer comprising a polyamide or a copolyamide, an outer layer positioned radially outward of the inner layer and comprising a polyester or a co-polyester, and an intermediate layer positioned between the inner layer and the outer layer and bonding the outer layer to the inner layer, the intermediate layer comprising a copolymer having a polyether segment and a polyamide segment, wherein the balloon is expandable through pressure applied to the inner surface of the wall; and expanding the balloon through pressure applied to the inner surface of the wall to expand the expandable implant at the portion of the patient’ s body.

[0221] Example 72: The method of any example herein, in particular Example 71, wherein the inner layer comprises a nylon 6, a nylon 12, or a nylon 6/6.

[0222] Example 73: The method of any example herein, in particular Example 71 or Example 72, wherein the intermediate layer comprises: a poly tetramethylene glycol segment, a polyethylene glycol segment, a polytetramethylene oxide segment, or a polyethylene oxide segment; and a polyamide 12 or a polyamide 6 segment.

[0223] Example 74: The method of any example herein, in particular Examples 71-73, wherein the outer layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a block copolymer having a polybutylene terephthalate segment and a polyether segment.

[0224] Example 75: The method of any example herein, in particular Examples 71-74, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a block copolymer having two carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0225] Example 76: The method of any example herein, in particular Examples 71-75, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0226] Example 77 : The method of any example herein, in particular Examples 71-76, wherein: the inner layer comprises a polyamide or a co-poly amide having six carbon atoms in a monomer of the polyamide or co-poly amide; the intermediate layer comprises a copolymer having two carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0227] Example 78: The method of any example herein, in particular Examples 71-77, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0228] Example 79: The method of any example herein, in particular Examples 71-78, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in one or more monomers of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having two carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0229] Example 80: The method of any example herein, in particular Examples 71-79, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in one or more monomers of the polyamide or the co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester layer having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

[0230] Example 81: The method of any example herein, in particular Examples 71-80, wherein the inner layer comprises 10 percent to 50 percent of a thickness of the wall.

[0231] Example 82: The method of any example herein, in particular Examples 71-81, wherein the intermediate layer comprises 1 percent to 10 percent of a thickness of the wall.

[0232] Example 83: The method of any example herein, in particular Examples 71-82, wherein the outer layer comprises 40 percent to 80 percent of a thickness of the wall. [0233] Example 84: The method of any example herein, in particular Examples 71-83, wherein the expandable implant is a prosthetic heart valve.

[0234] Example 85: The method of any example herein, in particular Examples 71-84, wherein the portion of the patient’ s body is a heart valve.

[0235] Any of the features of any of the examples, including but not limited to any of the first through 85 examples referred to above, is applicable to all other aspects and examples identified herein, including but not limited to any examples of any of the first through 85 examples referred to above. Moreover, any of the features of an example of the various examples, including but not limited to any examples of any of the first through 85 examples referred to above, is independently combinable, partly or wholly with other examples described herein in any way, e.g., one, two, or three or more examples may be combinable in whole or in part. Further, any of the features of the various examples, including but not limited to any examples of any of the first through 85 examples referred to above, may be made optional to other examples. Any example of a method can be performed by a system or apparatus of another example, and any aspect or example of a system or apparatus can be configured to perform a method of another aspect or example, including but not limited to any examples of any of the first through 85 examples referred to above.

[0236] In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific examples, one skilled in the art will readily appreciate that these disclosed examples are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and/or reagent, etc., described herein. As such, various modifications or changes to or alternative configurations of the disclosed subject matter can be made in accordance with the teachings herein without departing from the spirit of the present specification. Lastly, the terminology used herein is for the purpose of describing particular examples only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims. Accordingly, the systems, apparatuses, and methods are not limited to that precisely as shown and described.

[0237] Certain examples of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described examples will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein. Accordingly, the systems, apparatuses, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described examples in all possible variations thereof is encompassed by the systems, apparatuses, and methods unless otherwise indicated herein or otherwise clearly contradicted by context.

[0238] Groupings of alternative examples, elements, or steps of the systems, apparatuses, and methods are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0239] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

[0240] The terms “a,” “an,” “the” and similar referents used in the context of describing the systems, apparatuses, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the systems, apparatuses, and methods and does not pose a limitation on the scope of the systems, apparatuses, and methods otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the systems, apparatuses, and methods.

[0241] All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the systems, apparatuses, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

WHAT IS CLAIMED IS:

1. A method of making a balloon for insertion within a portion of a patient’s body, the method comprising: heating an elongate tube having a wall including three or more layers to a first temperature; radially stretching the wall of the elongate tube within a mold to form a molded elongate tube having the stretched wall; and removing a layer of the three or more layers of the stretched wall to form the balloon, the balloon being expandable through pressure applied to an inner surface of the balloon.

2. The method of claim 1, wherein the three or more layers include: a first layer, a second layer positioned adjacent to and radially outward of the first layer, and a third layer positioned adjacent to and radially outward of the second layer, the third layer forming an outer surface of the elongate tube; and removing the layer of the three or more layers of the stretched wall includes removing the third layer from the second layer.

3. The method of claim 2, wherein: the molded elongate tube includes a first end portion, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion; and removing the third layer includes cutting or scoring the first end portion and/or the second end portion to avoid damaging a portion of the second layer that is within the central portion of the molded elongate tube.

4. The method of claim 2 or claim 3, wherein the third layer is made of a material that is not thermally bondable with the second layer.

5. The method of any of claims 2-4, wherein: the first layer comprises a polyamide or a co-polyamide; the second layer comprises a polyester or a co-polyester; and the third layer comprises a polyamide or a co-polyamide.

6. The method of any of claims 1-5, further comprising co-extruding three or more molten thermoplastics to form the elongate tube.

7. The method of any of claims 1-6, wherein the first temperature is between 230 degrees Fahrenheit and 315 degrees Fahrenheit.

8. The method of any of claims 1-7, wherein: the mold is a blow mold; and radially stretching the wall of the elongate tube in the mold includes blow molding the wall to form the molded elongate tube having the stretched wall.

9. The method of claim 8, wherein the three or more layers include: a first layer, a second layer positioned adjacent to and radially outward of the first layer, and a third layer positioned adjacent to and radially outward of the second layer, the third layer forming an outer surface of the elongate tube; and wherein the third layer insulates the second layer during the blow molding to reduce crystallization of the second layer.

10. The method of any of claims 1-9, wherein the balloon is configured to dilate an expandable implant positioned on the balloon.

11. The method of claim 10, wherein the expandable implant is a prosthetic heart valve.

12. The method of any of claims 1-11, further comprising coupling the balloon to an elongate shaft of a catheter.

13. The method of claim 12, wherein the elongate shaft includes a fluid lumen for inflating the balloon.

14. The method of claim 12 or claim 13, wherein the elongate shaft is flexible to allow for deflection of the elongate shaft.

15. The method of any of claims 12-14, wherein the elongate shaft has a distal end portion and a proximal end portion, and the balloon is coupled to the distal end portion, and a handle is coupled to the proximal end portion.

16. A device for insertion within a portion of a patient’s body, the device comprising: a balloon having a blow molded wall including: an inner surface, a first layer, and a second layer positioned radially outward of the first layer, wherein the balloon is expandable through pressure applied to the inner surface of the blow molded wall, the blow molded wall being formed by: blow molding an elongate tube to form a blow molded elongate tube having the first layer, the second layer, and a third layer positioned radially outward of the second layer, the third layer being an insulation layer to reduce crystallization of the second layer during the blow molding, and removing the third layer from the blow molded elongate tube.

17. The device of claim 16, wherein the third layer of the blow molded elongate tube is positioned adjacent to the second layer of the blow molded elongate tube and made of a material that is not thermally bondable with the second layer.

18. The device of claim 16 or claim 17, wherein the third layer forms an outer surface of the blow molded elongate tube.

19. The device of any of claims 16-18, wherein the first layer comprises a polyamide or a copolyamide.

20. The device of any of claims 16-19, wherein the third layer comprises a polyamide or a co-polyamide.

21. The device of any of claims 16-20, wherein the second layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a thermoplastic elastomer co-polyester, or combinations thereof.

22. The device of any of claims 16-21, wherein: the blow molded elongate tube includes a first end portion, a second end portion opposite the first end portion, and a central portion between the first end portion and the second end portion; and removing the third layer includes cutting or scoring the first end portion and/or the second end portion to avoid damaging a portion of the second layer that is within the central portion of the blow molded elongate tube.

23. The device of any of claims 16-22, wherein the second layer comprises 50 percent to 75 percent of a wall thickness of the elongate tube.

24. The device of any of claims 16-23, wherein the third layer comprises 5 percent to 15 percent of a wall thickness of the elongate tube.

25. The device of any of claims 16-24, further comprising a catheter having an elongate shaft, wherein the balloon is coupled to the elongate shaft of the catheter.

26. A device for insertion within a portion of a patient’s body, the device comprising: a balloon having a wall including: an inner surface, an inner layer comprising a polyamide or a co-polyamide, an outer layer positioned radially outward of the inner layer and comprising a polyester or a co-polyester, and an intermediate layer positioned between the inner layer and the outer layer and bonding the outer layer to the inner layer, the intermediate layer comprising a copolymer having a polyether segment and a polyamide segment, wherein the balloon is expandable through pressure applied to the inner surface of the wall.

27. The device of claim 26, wherein the inner layer comprises a nylon 6, a nylon 12, or a nylon 6/6.

28. The device of claim 26 or claim 27, wherein the intermediate layer comprises: a polytetramethylene glycol segment, a polyethylene glycol segment, a polytetramethylene oxide segment, or a polyethylene oxide segment; and a polyamide 12 or a polyamide 6 segment.

29. The device of any of claims 26-28, wherein the outer layer comprises a polyethylene terephthalate, a polybutylene terephthalate, or a block copolymer having a polybutylene terephthalate segment and a polyether segment.

30. The device of any of claims 26-29, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a block copolymer having two carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

31. The device of any of claims 26-30, wherein: the inner layer comprises a polyamide or a co-polyamide having twelve carbon atoms in a monomer of the polyamide or the co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and twelve carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

32. The device of any of claims 26-31 , wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having two carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having two carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

33. The device of any of claims 26-32, wherein: the inner layer comprises a polyamide or a co-polyamide having six carbon atoms in a monomer of the polyamide or co-polyamide; the intermediate layer comprises a copolymer having four carbon atoms in a polyether block monomer and six carbon atoms in a polyamide block monomer; and the outer layer comprises a polyester or a co-polyester having four carbon atoms in a monomer of an ether segment of the polyester or the co-polyester.

34. The device of any of claims 26-33, wherein the balloon is configured to dilate an expandable implant positioned on the balloon.

35. The device of any of claims 26-34, further comprising a catheter having an elongate shaft, wherein the balloon is coupled to the elongate shaft of the catheter.