Catheter with fast exchange guidewire port and method of manufacture

Abstract

A quick exchange catheter (10) and associated methods of forming a port fitting for a quick exchange catheter are disclosed. The catheter includes an elongate shaft (12), a catheter hub (18) disposed at the proximal end of the elongate shaft, and a guidewire port (34) formed within the elongate shaft at a location distal to the proximal end of the elongate shaft and proximal to the distal end of the elongate shaft. A core wire (40) extends through the guidewire port and includes a distal end region secured to the elongate shaft distal to the guidewire port by means of one or more components of the elongate shaft that return around the core wire during manufacture of the rapid exchange catheter.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 397,526, filed on August 12, 2022, which is incorporated herein by reference. Technical Field

[0002] The present invention relates generally to intracorporeal medical devices and, more particularly, to intracorporeal medical devices such as rapid exchange catheters and methods of making rapid exchange catheters. Background Art

[0003] A wide variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0004] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. An example can be found in a rapid exchange catheter. The rapid exchange catheter includes an elongated shaft extending from a proximal end to a distal end, a catheter hub disposed at the proximal end of the elongated shaft, and a guidewire port formed in the elongated shaft at a position distal to the proximal end of the elongated shaft and proximal to the distal end of the elongated shaft. The core wire extends from a position proximal to the guidewire port through the guidewire port to a position distal to the guidewire port, and the core wire includes a distal region that is fixed to the elongated shaft distal to the guidewire port.

[0005] Alternatively or additionally, the distal region of the core wire may be secured to the elongated shaft distal to the guidewire port without the use of any adhesive.

[0006] Alternatively or additionally, the distal region of the core wire may be secured to the elongated shaft distal to the guidewire port during manufacture of the rapid exchange catheter by means of one or more components of the elongated shaft that flow back around the core wire.

[0007] Alternatively or additionally, the elongated shaft may include a distal inner shaft having an outer diameter (OD), a distal outer shaft having an inner diameter (ID), and a proximal shaft positioned prior to reflux, wherein the distal inner shaft is disposed within and extends proximally from the distal outer shaft; the proximal shaft surrounds the proximal end of the distal outer shaft and is adjacent to the proximal end of the distal inner shaft; and the core wire is disposed between the OD of the distal inner shaft and the ID of the distal outer shaft.

[0008] Alternatively or additionally, wherein prior to reflow, a port mandrel is inserted through the distal inner shaft; and a crescent mandrel is inserted between the OD of the distal inner shaft and the ID of the distal outer shaft.

[0009] Alternatively or additionally, the elongated shaft may include a distal outer shaft having a cavity, a distal inner shaft extending through the cavity of the distal outer shaft, and a proximal shaft extending proximally of the distal outer shaft and the distal inner shaft, wherein the core wire extends through the cavity of the proximal shaft such that a distal end region of the core wire is directly fixed between an outer surface of the distal inner shaft and an inner surface of the distal outer shaft.

[0010] Alternatively or additionally, the distal region of the core wire can be embedded between the distal inner shaft and the distal outer shaft.

[0011] Alternatively or additionally, the elongated shaft may include a crescent-shaped lumen extending proximally and distally of the guidewire port.

[0012] Alternatively or additionally, the centroid of the distal region of the core wire is laterally offset from a longitudinally extending plane passing through both the centroid of the lumen of the distal inner shaft and the centroid of the crescent-shaped lumen formed by the crescent-shaped mandrel.

[0013] Alternatively or additionally, the centroid of the distal region of the core wire is laterally offset from a longitudinally extending plane that passes through both the centroid of the elongated shaft and the centroid of the crescent-shaped lumen.

[0014] Alternatively or additionally, the crescent-shaped lumen may define a portion of an inflation lumen that extends through the elongated shaft to a balloon secured to the distal end of the elongated shaft.

[0015] Another example can be found in a rapid exchange catheter. The rapid exchange catheter includes an elongated shaft extending from a proximal end to a distal end and a catheter hub disposed at the proximal end of the elongated shaft. A port connector is formed along the elongated shaft between the proximal end of the elongated shaft and the distal end of the elongated shaft. The elongated shaft includes a proximal shaft extending proximally of the port connector, a distal inner shaft extending distally of the port connector, and a distal outer shaft extending distally of the port connector, wherein the distal end of the proximal shaft is fixed to the proximal end of the distal inner shaft and the proximal end of the distal outer shaft at the port connector. The lumen of the distal inner shaft is open to the outside of the elongated shaft at a guidewire port formed at the port connector, and a core wire extends distally through the guidewire port, and the core wire includes a distal region fixed to the elongated shaft at the port connector.

[0016] Alternatively or additionally, the distal region of the core wire may be secured to the elongate shaft at the port fitting without the use of any adhesive.

[0017] Alternatively or additionally, the distal region of the core wire may be secured to the elongated shaft at the port fitting by means of the proximal regions of the inner and outer distal shafts being backflowed around the core wire during manufacture of the port fitting.

[0018] Alternatively or additionally, in a cross-section taken through the port connector perpendicular to the central longitudinal axis of the elongated shaft, the cross-section can include a guidewire lumen having a center of mass spaced away from the central longitudinal axis of the elongated shaft in a first direction originating from the central longitudinal axis of the elongated shaft; and a crescent-shaped inflation lumen having a center of mass spaced away from the central longitudinal axis of the elongated shaft in a second direction originating from the central longitudinal axis of the elongated shaft, the second direction being opposite to the first direction.

[0019] Alternatively or additionally, in cross-section, the core wire may have a centroid spaced away from the central longitudinal axis of the elongated shaft in a third direction from the central longitudinal axis of the elongated shaft, the third direction being different from the first direction and the second direction.

[0020] Alternatively or additionally, the third direction may be at an acute angle to the first direction.

[0021] Another example can be found in a method of making a catheter with a rapid exchange guidewire port. The method includes forming an assembly by: disposing a distal inner shaft having an outer diameter (OD) within a distal outer shaft having an inner diameter (ID); disposing a distal region of the proximal shaft around a proximal region of the distal outer shaft, wherein the proximal region of the distal inner shaft extends adjacent to the distal region of the proximal shaft; inserting a first mandrel through a lumen of the distal inner shaft; inserting a second mandrel between the OD of the distal inner shaft and the ID of the distal outer shaft; and inserting a core wire between the OD of the distal inner shaft and the ID of the distal outer shaft. Thereafter, heat and pressure are applied to the assembly to form a rapid exchange guidewire port.

[0022] Alternatively or additionally, when the distal region of the proximal shaft is disposed about the proximal region of the distal outer shaft, the distal region of the proximal shaft may include an enlarged profile including tabs extending along the OD of the distal inner shaft.

[0023] Alternatively or additionally, the core wire may extend proximal to the rapid exchange guidewire port.

[0024] Alternatively or additionally, applying heat and pressure to the assembly may cause the distal inner shaft, distal outer shaft, and proximal shaft to melt and reflow around the first mandrel, second mandrel, and core wire, thereby locking the core wire in position relative to the rapid exchange guidewire port.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention may be more fully understood by considering the following detailed description of various embodiments of the invention taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 is a plan view of an illustrative rapid exchange balloon catheter;

[0028] Figure 2 It is along Figure 1 a cross-sectional view taken along line 2-2 of ;

[0029] Figure 3 is a perspective view of a distal inner shaft extending within a distal outer shaft;

[0030] Figure 4 yes Figure 3 A perspective view of a distal inner shaft and a distal outer shaft with a port mandrel extending within the distal inner shaft and a crescent mandrel prepared on the outer side thereof;

[0031] Figure 4A It is along Figure 4 a cross-sectional view taken along line 4-4 of ;

[0032] Figure 5 yes Figure 3 a perspective view of a distal inner shaft and a distal outer shaft with a port mandrel extending within the distal inner shaft, a crescent-shaped mandrel extending within a space between the distal inner shaft and the distal outer shaft, and a proximal shaft prepared externally thereof;

[0033] Figure 5A It is along Figure 5 a cross-sectional view taken along line 5-5 of ;

[0034] Figure 6 yes Figure 3 a perspective view of a distal inner shaft and a distal outer shaft with a port mandrel extending within the distal inner shaft, a crescent-shaped mandrel extending within a space between the distal inner shaft and the distal outer shaft, and a proximal shaft advanced over the distal inner shaft and the distal outer shaft, with a portion of the proximal shaft extending within the space between the distal inner shaft and the distal outer shaft to form an assembly;

[0035] Fig. 6A It is along Figure 6 a cross-sectional view taken along line 6A-6A of ;

[0036] Figure 6B It is along Figure 6 a cross-sectional view taken along line 6B-6B of ;

[0037] Figure 7 It shows that the setting Figure 6 A three-dimensional view of a heat shrink tubing on a component;

[0038] Fig. 7A It is along Figure 7 a cross-sectional view taken along line 7-7 of ;

[0039] Figure 8 is shown after applying heat and pressure Figure 7 a perspective view of the components and heat shrink tubing; and

[0040] Fig. 9 is shown after additional heat is applied Figure 7 A perspective view of the components and heat shrink tubing.

[0041] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that the present invention is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0042] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which the same reference numerals in several views indicate the same elements. The specific embodiments and the accompanying drawings are intended to illustrate, not to limit, the present invention. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description and the accompanying drawings illustrate example embodiments of the present invention. However, for the purpose of clarity and ease of understanding, although each feature and / or element may not be shown in each drawing, the features and / or elements may also be understood to be present unless otherwise stated.

[0043] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0044] All numerical values ​​herein are assumed to be modified by the term "about", whether or not expressly indicated otherwise. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the cited number (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0045] The recitation of numerical ranges by endpoints includes all numbers within that range (eg 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0046] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0047] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or" unless the content clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance in a feature may include and / or contain a singular disclosure unless explicitly indicated to the contrary. For simplicity and clarity, not all elements of the present invention will necessarily be shown in each figure or discussed in detail below. However, it should be understood that, unless explicitly stated to the contrary, the following discussion may be equally applicable to any and / or all of the components where there is more than one. Additionally, for clarity, all instances of some elements or features may not be shown in each figure.

[0048] Relative terms, such as "proximal", "distal", "advance", "retract", variations thereof, etc., may generally be considered with respect to the positioning, orientation and / or operation of various elements relative to a user / operator / manipulator of the device, wherein "proximal" and "retract" mean or refer to being closer to or toward the user and "distal" and "advance" mean or refer to being farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present invention, and such circumstances will be apparent to the skilled person. Other relative terms, such as "upstream", "downstream", "inflow" and "outflow" refer to the direction of fluid flow in a cavity, such as a body cavity, a blood vessel, or within a device. Other relative terms, such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc., and / or variations thereof, generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0049] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to use the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, may still be considered to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0050] For the sake of clarity, various descriptions and / or claimed features may be named and / or distinguished using certain identifying digital nomenclature (e.g., first, second, third, fourth, etc.) throughout the specification and / or claims. It should be understood that the digital nomenclature is not intended to be limiting and is merely exemplary. In certain embodiments, for simplicity and clarity, the digital nomenclature previously used may be changed and deviated from. That is, the feature identified as a "first" element may be referred to as a "second" element, a "third" element, etc., later, or may be omitted completely, and / or different features may be referred to as a "first" element. The meaning and / or name in each case will be apparent to the technician.

[0051] Figure 1 1 is a side view of an illustrative catheter 10, such as a balloon catheter. The catheter 10 may include a catheter shaft 12 extending from a proximal region 14 to a distal region 16. A hub 18 may be secured to the catheter shaft 12 at the proximal region 14, wherein the catheter shaft 12 extends distally from the hub 18. In some cases, the hub 18 may include a Luer fitting 20 that allows other devices to be connected to the hub 18. In some cases, the Luer fitting 20 may be used to fluidly couple the catheter 10 to a source of inflation fluid, such as, but not limited to, saline. The catheter 10 may include an inflatable balloon 22 mounted on the distal region 16 of the catheter shaft 12. The inflatable balloon 22 may be in contact with an inflation lumen (not shown). Figure 1 1 and 12 ) are fluidly coupled, the inflation lumen extending through the catheter shaft 12 and through the hub 18 to the Luer fitting 20. In some cases, the catheter shaft 12 can include an outer tubular member extending to a proximal waist of the inflatable balloon 22 and an inner tubular member extending distally beyond the outer tubular member to a distal waist of the inflatable balloon 22. The proximal waist 24 can be fixed to the outer surface of the outer tubular member, and the distal waist can be fixed to the outer surface of the inner tubular member. Various construction techniques for how to make the inflatable balloon 22 and how to fix the inflatable balloon 22 relative to the catheter shaft 12 are known and can be applied.

[0052] In some cases, as shown, one or more marker bands 25 can be fixed relative to the catheter shaft 12. In some cases, one of the marker bands 25 can be positioned to indicate, via fluoroscopy, a distal region of the inflatable balloon 22 proximal to the distal cone of the inflatable balloon 22, and one of the marker bands 25 can be positioned to indicate, via fluoroscopy, a proximal region of the inflatable balloon 22 proximal to the proximal cone of the inflatable balloon 22. This allows a physician or other professional advancing the catheter 10 through the patient's vasculature to the appropriate treatment site to understand where the body of the inflatable balloon 22 is located relative to the appropriate treatment site before inflating the inflatable balloon 22. In some cases, the catheter 10 can be considered to have a central longitudinal axis L.

[0053] In many cases, the catheter 10 can be advanced over a guidewire to reach an appropriate treatment site. In some cases, the catheter 10 can have a distal guidewire port 32, which is located at the distal end of the catheter shaft 12 distal to the inflatable balloon 22, and the distal guidewire port 32 is suitable for accommodating a guidewire (not shown) extending distally from the distal guidewire port 32. The catheter 10 can have a proximal guidewire port 34, which is located proximal to the distal end of the catheter 10 and distal to the proximal end of the catheter 10. The proximal guidewire port 34 can be located at a short distance proximal to the inflatable balloon 22 at the distal position of the hub 18. In some cases, in view of the relative position of the proximal guidewire port 34, the catheter 10 can be regarded as a rapid exchange catheter, which means that the guidewire only extends through a relatively short portion of the catheter shaft 12 of the catheter 10, rather than extending through the entire length of the catheter shaft 12 of the catheter 10 (this will be referred to as an OTW or "on-the-wire" catheter). Rapid exchange catheters have many advantages, including making it easier to advance catheter 10 over a guidewire, withdraw catheter 20 from a guidewire, and replace catheter 10 with a different medical device.

[0054] Figure 2 It is along Figure 1 2-2 of the cross-sectional view of the shaft 12 intercepted. It should be understood that this cross section is only intercepted at the far side of the proximal guide wire port 34. In some cases, as will be discussed, this cross section represents several different catheter parts that are fused, bonded or otherwise combined together in the reflow process forming the proximal guide wire port 34, while maintaining the unobstructedness of one or more lumens extending through the catheter shaft 12. The reflow process may involve applying heat and / or pressure to melt and reflow one or more catheter parts or one or more catheter parts, thereby fixing one or more catheter parts together when the catheter parts cool and solidify. In some cases, the proximal guide wire port 34 itself is formed as a part of the reflow process.

[0055] like Figure 2, the catheter shaft 12 includes a guidewire lumen 36. As shown, the guidewire lumen 36 has a circular cross-sectional shape and is sized to receive a guidewire therethrough. The guidewire lumen 36 can be considered to have a centroid 36a that is spaced apart from a point representing the central longitudinal axis L of the catheter shaft 12 in a first direction. The catheter shaft 12 also includes an inflation lumen, which can be a crescent-shaped inflation lumen 38 through a port connector region of the catheter shaft 12 having a proximal guidewire port 34. The crescent-shaped inflation lumen 38 can be considered to have a centroid 38a that is spaced apart from a point representing the central longitudinal axis L of the catheter shaft 12 in a second direction. In some cases, as will be discussed, the guidewire lumen 36 and the crescent-shaped inflation lumen 38 can be formed, and / or the patency of the guidewire lumen 36 and the crescent-shaped inflation lumen 38 can be protected during the reflux process using a mandrel that defines and / or preserves the guidewire lumen 36 and the crescent-shaped inflation lumen 38 during the reflux process.

[0056] The catheter shaft 12 also includes a core wire 40 extending along the length of the catheter shaft 12. The core wire 40 can extend proximally through the catheter shaft 12 and can be fixed at its proximal end within the hub 18. The proximal end of the core wire 40 can be adhesively fixed within the hub 18. In some cases, the proximal end of the core wire 40 can be fixed within the hub 18 via mechanical interference, such as but not limited to friction fit. The distal region of the core wire 40 can be fixed in place due to a backflow process that causes the polymer material of some of the catheter components to melt and backflow around the distal region of the core wire 40. The core wire 40 can be considered to have a center of mass 40a that is spaced apart from a point representing the central longitudinal axis L of the catheter shaft 12 in a third direction. In some cases, the first direction (the spacing of the guidewire lumen 36), the second direction (the spacing of the crescent-shaped inflation lumen 38), and the third direction (the spacing of the core wire 40) are all different. In some cases, the first direction may be directly opposite (eg, 180 degrees apart) the second direction, and the third direction may extend at an acute angle to the first direction.

[0057] The catheter shaft 12 is at least Figure 2In the region identified by the cross section, it can be regarded as a port joint with a catheter body 42, as will be discussed, the catheter body 42 is formed by a reflow process, in which one or more catheter components or parts of one or more catheter components are melted and reflowed. Therefore, the catheter body 42 or its part can be formed by a plurality of different catheter components, such as but not limited to the shaft portion, and the different catheter components are melted and reflowed to combine different catheter components together. Therefore, the catheter body 42 can be formed by a plurality of different polymer tubes formed by the same or different polymer materials. Although the catheter body 42 is shown as an integral structure, it should be understood that the different polymer materials of the various tubular members forming the catheter body 42 can be mixed together evenly or unevenly. In some cases, the different polymer materials of the various tubular members forming the catheter body 42 can be mixed unevenly, but can be concentrated in a specific part or segment of the catheter body 42. The following figure provides an illustrative but non-limiting example of how the catheter body 42 and the proximal guidewire port 34 formed in the catheter body 42 can be formed.

[0058] Figure 3 The initial steps of forming the catheter body 42 and the proximal guidewire port 34 are shown. Figure 3 , it can be seen that the distal inner tubular shaft 44 extends within the distal outer tubular shaft 46. In some cases, the distal inner tubular shaft 44 can extend distally through the inflatable balloon 22, and can extend at least to the distal waist 26 of the inflatable balloon 22 to be secured thereto. In some cases, the distal outer tubular shaft 46 can extend distally to the inflatable balloon 22, and can extend at least to the proximal waist 24 of the inflatable balloon 22 to be secured thereto. As an example, the distal waist 26 of the inflatable balloon 22 can be secured to the distal region of the distal inner tubular shaft 44, and the proximal waist 24 of the inflatable balloon 22 can be secured to the distal region of the distal outer tubular shaft 46. For example, the proximal waist 24 of the inflatable balloon 22 can be adhesively secured or thermally bonded (e.g., laser bonded or hot clamp bonded) to the distal outer tubular shaft 46. In some cases, the distal waist 26 of the inflatable balloon 22 can be adhesively secured or thermally bonded (eg, laser bonding or heat clamp bonding) to the distal inner tubular shaft 44 .

[0059] It should be understood that the distal inner tubular shaft 44 can have an inner diameter (ID) and an outer diameter (OD). The ID of the distal inner tubular shaft 44 can define the lumen of the distal inner tubular shaft 44. The lumen of the distal inner tubular shaft 44 can be a guidewire lumen extending from the proximal guidewire port 34 to the distal guidewire port 32. The distal outer tubular shaft 46 can have an inner diameter (ID) and an outer diameter (OD). The ID of the distal outer tubular shaft 46 can define the lumen of the distal outer tubular shaft 44, through which the distal inner tubular shaft 44 extends. In some cases, a space 48 can be defined between the OD (e.g., outer surface) of the distal inner shaft 44 and the ID (e.g., inner surface) of the distal outer shaft 46. The space 48 can be annular, for example, through a portion of the length of the catheter shaft 12 distal to the proximal guidewire port 34, or can have a cross-sectional profile depending on the position of the distal inner tubular shaft 44 relative to the distal outer tubular shaft 46. The distal inner tubular shaft 44 can move or shift relative to the distal outer tubular shaft 46, depending on, for example, whether any mandrel has been inserted. The distal inner tubular shaft 44 can have an ID ranging from about 0.008 inches to about 0.5 inches, and an OD ranging from about 0.009 inches to about 0.6 inches. The distal outer tubular shaft 46 can have an ID ranging from about 0.01 inches to about 0.61 inches, and an OD ranging from about 0.011 inches to about 0.62 inches. Due to the difference between the OD of the distal inner tubular shaft 44 and the ID of the distal outer tubular shaft 46, the annular space 48 between the OD of the distal inner tubular shaft 44 and the ID of the distal outer tubular shaft can be about 0.001 inches to about 0.6 inches, thereby presenting that the distal inner tubular shaft 44 remains centered within the distal outer tubular shaft 46.

[0060] The cavity 50 is limited by the distal inner tubular shaft 44 and extends through the distal inner tubular shaft 44. The cavity 50 can form a guidewire cavity, which extends from the proximal guidewire port 34 through the distal inner tubular shaft 44 to the distal guidewire port 32. The distal inner tubular shaft 44 can have a proximal end 52, which is cut with an acute angle α (alpha) with respect to a transverse plane 54 perpendicular to the central longitudinal axis of the distal inner tubular shaft 44. For example, the scope of the acute angle α can be 10 to 80 degrees. In other cases, the proximal end 52 can be cut perpendicular to the central longitudinal axis of the distal inner tubular shaft 44. The proximal end 52 of the distal inner tubular shaft 44 can form a part of the proximal guidewire port 34, as further discussed herein. The distal inner tubular shaft 44 can be formed by any suitable polymer, including those listed below. The distal outer tubular shaft 46 can be formed by any suitable polymer, including those listed below.

[0061] Figure 4 Shown in Figure 3 Several mandrels are added to the structure shown in . Figure 4A It is along Figure 44A-4A of the cross-sectional view. As shown, the guidewire port mandrel 56 has been inserted into the cavity 50 defined by the distal inner tubular shaft 44. In some cases and as Figure 4A , the port mandrel 56 can have a circular cross-sectional profile. As a result, the port mandrel 56 maintains the lumen 50 extending within the distal inner tubular shaft 44 during the subsequent heating of the reflow process, as described herein. The port mandrel 56 can be formed of any suitable material capable of withstanding the heat and pressure applied during the subsequent reflow process. As an example, the port mandrel 56 can be formed of a metal, such as stainless steel. The crescent-shaped mandrel 58 has not yet been inserted, but is ready to be inserted into the space 48 defined between the outer surface of the distal inner tubular shaft 44 and the inner surface of the distal outer tubular shaft 46.

[0062] exist Figure 5 , the crescent-shaped mandrel 58 has been inserted into the annular space 48 between the outer surface of the distal inner tubular shaft 44 and the inner surface of the distal outer tubular shaft 46. The proximal shaft 60 is ready to be positioned relative to the other components. The lumen of the proximal shaft 60 can define an inflation lumen in fluid communication with the hub 18 to provide inflation fluid to the interior of the inflatable balloon 22. When the proximal shaft is secured to the distal inner shaft and the distal outer shaft at a port connector, as further described herein, the lumen of the proximal shaft 60 can be in fluid communication with the crescent-shaped inflation lumen 38 extending through the catheter body 42 at the port connector, and the inflation lumen defined by the annular space between the outer surface of the distal inner shaft 44 and the inner surface of the distal outer shaft 46 extends to the inflatable balloon 22 distally of the port connector. The proximal shaft 60 can have a flared distal region 62 to facilitate insertion of the distal outer tubular shaft 46 into the distal region 62 of the proximal shaft 60 such that the distal region 62 surrounds the proximal region of the distal outer tubular shaft 46. Thus, for example, the flared distal region 62 can facilitate fitting of the proximal shaft 60 around the distal outer shaft 46. In some cases, as shown, the distal region 62 of the proximal shaft 60 includes a pair of slots 64 defining a tab 66 therebetween that is part of the distal region 62 of the proximal shaft 60. In some cases, as will be described with respect to Fig. 6A As shown, the tab 66 may extend into the space 48 between the outer surface of the distal inner tubular shaft 44 and the inner surface of the distal outer tubular shaft 46 , wherein the distal inner tubular shaft 44 extends along the outer surface of the tab 66 prior to the reflow process.

[0063] In some cases, the core wire 40 can extend through the lumen of the proximal shaft 60 and extend distally of the distal end of the proximal shaft 60 before the proximal shaft 60 is coupled to the distal inner shaft 44 and the distal outer shaft 46. For example, the hub 18 can be fixed to the proximal end of the proximal shaft, and the proximal end of the core wire 40 can be fixed within the hub 18, wherein the core wire 40 extends distally through the lumen of the proximal shaft 60 before the distal inner shaft 44 and the distal outer shaft 46 are coupled to the proximal shaft 60.

[0064] exist Figure 6 , the proximal shaft 60 has been advanced distally over the distal outer tubular shaft 46, wherein the crescent-shaped mandrel 58 extends through the lumen of the proximal shaft 60 into the space 48 between the outer surface of the distal inner tubular shaft 44 and the inner surface of the distal outer tubular shaft 46, and the proximal end region of the distal inner shaft 44 extends along the exterior of the tab 66 such that the tab 66 is juxtaposed with the crescent-shaped mandrel 58, as shown in FIG. Fig. 6A As shown. The port mandrel 56 extends proximally from the lumen 50 of the distal inner tubular shaft 44 along the exterior of the distal end region of the proximal tubular shaft 60. For example, as Fig. 6A As shown, the tab 66 is inserted into the space 48 between the distal inner tubular shaft 44 and the distal outer tubular shaft 46 in a manner parallel to and facing the crescent-shaped mandrel 58. As shown, the tab 66 is disposed between the convex outer surface of the distal inner shaft 44 and the concave surface of the crescent-shaped mandrel 58. In some cases, if desired, the tab 66 can be disposed to one side of the crescent-shaped mandrel 58 (relative to the orientation shown).

[0065] Furthermore, when the distal end region of the proximal shaft 60 is advanced distally around the proximal end region of the distal outer shaft 46, the distal end region of the core wire 40 can be inserted into the space 48 between the distal inner tubular shaft 44 and the distal outer tubular shaft 46 side by side with the crescent-shaped mandrel 58. Fig. 6A As shown, it can be seen that the core wire 40 is disposed in a space 48 between the outer surface of the distal inner tubular shaft 44 and the inner surface of the distal outer tubular shaft 46. As noted, the core wire 40 extends from the hub 18 through the lumen of the proximal shaft 60. The exact location of the core wire 40 is merely illustrative, as the core wire 40 may be located on the opposite side of the crescent-shaped mandrel 58, for example. Figure 6An assembly 68 may be viewed as being shown, comprising a distal inner shaft 44 disposed within a distal outer shaft 46, a port mandrel 56 disposed within a lumen 50 of the distal inner shaft 44, a crescent mandrel 58 disposed within a space 48 between the distal inner shaft 44 and the distal outer shaft 46, a core wire 40 extending within a proximal shaft 60 into the space 48 between the distal inner shaft 44 and the distal outer shaft 46, a flared distal region 62 of the proximal shaft 60 extending around a proximal region of the distal outer shaft 46, and a proximal region of the distal inner shaft 44 extending along an exterior of a tab 66 of the proximal shaft 60. The assembly 68 may be subjected to heat and / or pressure in order to induce a reflow process.

[0066] Figure 7 Heat shrink tubing 70 is shown disposed on assembly 68 . Fig. 7A It is along Figure 7 Heat shrink tubing 70 is shown schematically and may provide a tighter fit to assembly 68 even before any heat and / or pressure is applied. Figure 8 The assembly 68 is shown disposed between heat blocks 72 and 74, and the heat shrink tubing 70. The heat blocks 72 and 74 dissipate heat to reduce the diameter of the heat shrink tubing 70 to fit tightly around the outer periphery of the assembly 68. The length of the heat shrink tubing 70 can be sufficient to span the entire area that will be subjected to the reflow process that joins together the proximal region of the distal inner tubular shaft 44, the proximal region of the distal outer tubular shaft 46, and the distal region of the proximal tubular shaft 60 to form the port fitting. In some cases, the heat blocks 72 and 74 are moved toward the assembly 68 and the heat shrink tubing 70 to provide pressure on the assembly 68 and the heat shrink tubing 70.

[0067] Once the heat shrink tubing 70 is secured around the assembly 68, heat may be applied to the area to melt the polymer material of the proximal region of the distal inner tubular shaft 44, the proximal region of the distal outer tubular shaft 46, and the distal region of the proximal tubular shaft 60 to allow the polymer material to melt and reflow together. In some cases, a laser may be used to provide heat during the reflow process. Fig. 9 As shown, the laser 76 provides a laser beam 78 that provides additional heating to the heat shrink tubing 70 and the assembly 68. As a result, the diameter of the heat shrink tubing 70 is further reduced, thereby applying additional compressive force to the assembly 68. The combination of heat and pressure causes reflow to occur. As a result, the proximal region of the distal inner shaft 44, the proximal region of the distal outer shaft 46, and the flared distal region 62 of the proximal shaft 60 (including the tabs 66) at least partially melt and reflow together, thereby creating a port joint in the catheter body 42 at the proximal guidewire port 34 of the catheter shaft 12, as shown. Figure 2As shown, the distal region of the core wire 40 is encapsulated in the catheter body 42. The crescent-shaped cavity 38 extending through the port connector can be connected to the cavity of the proximal shaft 60 and the annular cavity fluid between the inner surface of the distal outer shaft 46 and the outer surface of the distal inner shaft 44 located at the distal end of the port connector. In some cases, the length of the port connector where the proximal region of the distal inner tubular shaft 44, the proximal region of the distal outer tubular shaft 46 and the distal region of the proximal tubular shaft 60 are refluxed together can be about 0.5 millimeters (mm) to about 25mm. As a result of the reflux process, the distal region of the core wire 40 can be fixed in the catheter body 42 of the catheter shaft 12 located at the distal end of the proximal guidewire port 34, without the use of any adhesive or other components except the proximal region of the distal inner tubular shaft 44, the proximal region of the distal outer tubular shaft 46 and the distal region of the proximal tubular shaft 60. In some cases, the distal tip of the core wire 40 can extend distally a short distance from the fixed distal end region of the core wire 40 within the inflation lumen defined between the inner surface of the distal outer tubular shaft 46 and the outer surface of the distal inner tubular shaft 44. For example, in some cases, the fixed region of the core wire 40 (where the core wire 40 is captured by the backflow polymer around the core wire 40) can have a length of about 0.5 mm to about 25 mm, about 1 mm to about 10 mm, about 2 mm to about 5 mm, about 2 mm to about 4 mm, or about 2.5 mm, and the length of the core wire 40 extending distally of the fixed region can have a length of about 0.5 centimeters (cm) to 50 cm, about 3 cm to about 7 cm, about 4 cm to about 6 cm, about 5 cm to about 6 cm, or about 5.5 cm. In some cases, the core wire 40 may not extend distally of the fixed region.

[0068] The devices described herein and their various components may be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. In addition, the various structures may include materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material. These materials may include transparent or translucent materials to facilitate visualization during surgery. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; combinations thereof; etc.; or any other suitable material.

[0069] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont ), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (for example, commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as those commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc.

[0070] In some embodiments, the system disclosed herein and / or other elements may include a fabric material disposed above or within the structure. The fabric material may be composed of a biocompatible material suitable for promoting tissue endo-growth, such as a polymer material or a biomaterial. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials, such as polyethylene, polypropylene, polyester, polyurethane and / or a mixture or combination thereof.

[0071] In some embodiments, the system and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); anti-tumor / antiproliferative / anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone); ketones, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0072] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A rapid exchange catheter, comprising: An elongated shaft extending from the proximal end to the distal end; a catheter hub disposed at the proximal end of the elongated shaft; a guidewire port formed in the elongated shaft distal to the proximal end of the elongated shaft and proximal to the distal end of the elongated shaft; as well as a core wire extending from a position proximal to the guidewire port through the guidewire port to a position distal to the guidewire port; The core wire includes a distal region secured to the elongated shaft distal to the guidewire port. 2 . The rapid exchange catheter of claim 1 , wherein the distal region of the core wire is secured to the elongated shaft distal to the guidewire port without the use of any adhesive.

3. A rapid exchange catheter according to any one of claims 1 or 2, wherein the distal region of the core wire is fixed to the slender shaft distal to the guidewire port during manufacture of the rapid exchange catheter by means of one or more components of the slender shaft that flow back around the core wire.

4. The rapid exchange catheter of any one of claims 1 to 3, wherein the elongated shaft comprises a distal inner shaft having an outer diameter (OD), a distal outer shaft having an inner diameter (ID), and a proximal shaft positioned prior to flashback, wherein: The distal inner shaft is disposed within the distal outer shaft and extends proximally from the distal outer shaft; The proximal shaft surrounds the proximal end of the distal outer shaft and is adjacent to the proximal end of the distal inner shaft; and The core wire is disposed between the outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft.

5. The rapid exchange catheter according to any one of claims 1 to 4, wherein prior to backflow: a port mandrel is inserted through the distal inner shaft; and A crescent-shaped mandrel is inserted between the outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft.

6. A rapid exchange catheter according to any one of claims 1 to 5, wherein the slender shaft includes a distal outer shaft having a cavity, a distal inner shaft extending through the cavity of the distal outer shaft, and a proximal shaft extending proximally of the distal outer shaft and the distal inner shaft, wherein the core wire extends through the cavity of the proximal shaft so that the distal end region of the core wire is directly fixed between the outer surface of the distal inner shaft and the inner surface of the distal outer shaft.

7. The rapid exchange catheter of claim 6, wherein the distal region of the core wire is embedded between the distal inner shaft and the distal outer shaft.

8. A rapid exchange catheter according to any one of claims 6 or 7, wherein the center of mass of the distal region of the core wire is laterally offset from a longitudinally extending plane that passes through both the center of mass of the cavity of the distal inner shaft and the center of mass of the crescent-shaped cavity formed by the crescent-shaped core shaft.

9. A rapid exchange catheter, comprising: An elongated shaft extending from the proximal end to the distal end; a catheter hub disposed at the proximal end of the elongated shaft; a port fitting formed along said elongated shaft between said proximal end of said elongated shaft and said distal end of said elongated shaft; The elongated shaft comprises a proximal shaft extending proximally of the port connector, a distal inner shaft extending distally of the port connector, and a distal outer shaft extending distally of the port connector, wherein a distal end of the proximal shaft is fixed to a proximal end of the distal inner shaft and a proximal end of the distal outer shaft at the port connector; wherein the lumen of the distal inner shaft opens to the exterior of the elongated shaft at a guidewire port formed at the port connector; as well as A core wire extends distally through the guidewire port, the core wire including a distal end region secured to the elongated shaft at the port fitting.

10. A rapid exchange catheter according to claim 9, wherein the distal region of the core wire is fixed to the slender shaft at the port connector by means of the proximal region of the inner distal shaft and the proximal region of the outer distal shaft being reflowed around the core wire during manufacturing of the port connector.

11. The rapid exchange catheter of any one of claims 9 or 10, wherein in a cross section taken through the port connector perpendicular to the central longitudinal axis of the elongated shaft, the cross section comprises a guidewire lumen and a crescent-shaped inflation lumen, the centroid of the guidewire lumen being spaced apart from the central longitudinal axis of the elongated shaft in a first direction from the central longitudinal axis of the elongated shaft; the centroid of the crescent-shaped inflation lumen being spaced apart from the central longitudinal axis of the elongated shaft in a second direction from the central longitudinal axis of the elongated shaft, the second direction being opposite to the first direction.

12. The rapid exchange catheter of claim 11, wherein in the cross-section, the center of mass of the core wire is spaced apart from the central longitudinal axis of the elongated shaft in a third direction from the central longitudinal axis of the elongated shaft, the third direction being different from the first direction and the second direction.

13. A method of manufacturing a catheter having a rapid exchange guidewire port, the method comprising: The components are formed by: disposing a distal inner shaft having an outer diameter (OD) within a distal outer shaft having an inner diameter (ID); disposing a distal region of the proximal shaft about a proximal region of the distal outer shaft, wherein the proximal region of the distal inner shaft extends adjacent to the distal region of the proximal shaft; inserting a first mandrel through the lumen of the distal inner shaft; inserting a second mandrel between the outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft; as well as inserting a core wire between the outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft; as well as Thereafter, heat and pressure are applied to the assembly to form the rapid exchange guidewire port.

14. The method of claim 13, wherein when the distal region of the proximal shaft is disposed about the proximal region of the distal outer shaft, the distal region of the proximal shaft comprises an enlarged profile comprising a tab extending along the outer diameter of the distal inner shaft.

15. A method according to any one of claims 13 or 14, wherein applying heat and pressure to the assembly causes the distal inner shaft, the distal outer shaft and the proximal shaft to melt and reflow around the first mandrel, the second mandrel and the core wire, thereby locking the core wire in an appropriate position relative to the rapid exchange guidewire port.

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