Balloon protector and balloon catheter assembly

Abstract

Disclosed herein are balloon protectors, balloon catheters including balloon protectors, and methods thereof. A balloon protector (100) includes a balloon covering segment (106) and a tab segment (110) located proximally of the balloon covering segment. The balloon covering segment is configured to cover a drug coated balloon of a balloon catheter. The balloon covering segment includes a tip piece (104) of the balloon protector coupled to a distal end portion of a main body piece of the balloon protector. The tab segment includes a pair of tabs (122) configured to be continuously pulled away from each other to progressively separate the balloon protector along the balloon covering segment until the balloon protector is completely stripped from the balloon. Advantageously, an outer diameter of the tip piece can provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector covers the balloon of the balloon protector.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Patent Application No. 62 / 969,900, filed February 4, 2020, which is incorporated herein in its entirety. Background Technology

[0003] Atherosclerosis is characterized by one or more intravascular lesions, partly formed by plaques containing blood-derived substances such as fat, cholesterol, and calcium. Intravascular lesions, such as arterial lesions, can form on the wall of the arterial lumen and extend across it to the opposite wall. The final point of opening usually occurs at the boundary between the arterial lesion and the opposite wall of the arterial lumen. Surgical treatments for atherosclerosis, such as balloon angioplasty using a drug-coated balloon, can be used to restore the opening and blood flow loss of one or more intravascular lesions.

[0004] Balloon protectors are designed to cover and protect the drug-coated balloon of a balloon catheter during transport or preoperative preparation, which is necessary to maintain the integrity of the balloon catheter for its intended surgical procedure. Additionally, balloon protectors protect clinicians and others from unintentional contact with the antiproliferative drugs on the drug-coated balloon when handling the balloon catheter prior to the surgical procedure. While the aforementioned need for balloon protectors persists, other needs exist, such as preventing the balloon catheter from advancing through the guide tube sheath without first removing its balloon protector.

[0005] This article discloses balloon protectors that meet or exceed the above requirements, including balloon catheters for balloon protectors and methods thereof. Summary of the Invention

[0006] This invention discloses a balloon protector for a balloon catheter. The balloon protector includes a balloon covering section and a tabbed section located proximal to the balloon covering section. The balloon covering section is configured to cover a drug-coated balloon of the balloon catheter. The balloon covering section includes an end piece of the balloon protector, which is coupled to a distal portion of the body of the balloon protector. The tabbed section includes a pair of tabs configured to be continuously pulled away from each other to progressively separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon.

[0007] In some embodiments, the endpiece has a tapered portion with an inner diameter taper (configured to match the outer diameter of the distal shoulder of the balloon). The inner diameter taper of the endpiece is configured to maintain concentricity between an opening in the distal endpiece and an opening in the distal end of the balloon catheter axis for passage of a guidewire.

[0008] In some embodiments, the end effector has an overlapping portion above the distal portion of the body. In other words, the overlapping portion partially overlaps the distal portion of the body. The outer diameter of the overlapping portion is larger than the outer diameter of the immediately adjacent portion of the balloon-covered section. The outer diameter of the overlapping portion of the end effector is configured to provide a stop to prevent the balloon catheter from being inserted into the guide tube sheath when the balloon protector covers the balloon.

[0009] In some embodiments, the endpiece includes a longitudinal gap on each of the two opposite sides of the balloon protector. The length of the longitudinal gap is greater than or equal to the length of the overlapping portion of the endpiece. The balloon protector is configured such that the length of the longitudinal gap allows the distal portion of the body piece to be separated through the distal end of the body piece without increasing the applied peeling force.

[0010] In some implementations, the length of the longitudinal gap is greater than the length of the overlapping portion of the end piece. Due to the length of the longitudinal gap, the balloon protector is configured such that a through-hole is formed between the distal end of the longitudinal gap and the distal end of the body piece.

[0011] In some embodiments, the balloon protector is configured such that the through-hole is configured to provide an interruption to the applied peeling force when the balloon protector is separated along the balloon-covered section, the interruption indicating separation at the distal end through the body.

[0012] In some implementations, both the main body and the end pieces of the balloon coverage segment include paired, opposing longitudinal weakening lines aligned with the flaps. The balloon protector is configured such that the balloon coverage segment is separated along each of the weakening lines.

[0013] In some implementations, the balloon coverage segment further includes a transition segment configured to cover the proximal shoulder of the balloon. The transition segment has an outer diameter opening extending from the (immediately adjacent) distal portion of the balloon coverage segment to the distal end of the protruding segment. The outer diameter opening is configured to increase the distance between the flaps. This is optional for making the flaps easier to grip.

[0014] In some implementations, each tab in the pair includes an inner surface and an outer surface. The inner and outer surfaces of each tab may optionally have a texture. This is optional for making the tab easier to grip.

[0015] This document also discloses a catheter assembly. In some embodiments, the catheter assembly includes a balloon catheter and a balloon protector. The balloon catheter includes an axle and a drug-coated balloon arranged in an uninflated state around a distal portion of the axle. The balloon protector may be a balloon protector of any of the segments 4 to 12 above. For example, the balloon protector may include a balloon covering segment and a protruding segment located proximal to the balloon covering segment. The balloon covering segment covers the balloon of the balloon catheter. The balloon covering segment includes an end piece of the balloon protector coupled to the distal portion of the body piece of the balloon protector. The protruding segment includes a pair of tabs configured to be continuously pulled away from each other to progressively separate the balloon protector along the balloon covering segment until the balloon protector is completely detached from the balloon.

[0016] In some embodiments, the endpiece has a tapered portion with an inner diameter taper that conforms to the outer diameter of the distal shoulder of the balloon. The inner diameter taper of the endpiece is configured to maintain concentricity between an opening in the distal end of the endpiece and an opening in the distal end of the balloon catheter axis for passage of a guidewire.

[0017] In some embodiments, the catheter assembly also includes a core needle disposed within the guidewire lumen of the balloon catheter shaft, such that the catheter assembly is configured to maintain its integrity during transport or preoperative treatment. The core needle has a coiled distal portion extending from an opening in the distal end of the balloon protector's distal end piece, the coiled distal portion being configured to be gripped to pull the core needle out of the catheter assembly.

[0018] In some embodiments, the endpiece has an overlapping portion above the distal portion of the body. The outer diameter of the overlapping portion is larger than the outer diameter of the immediately adjacent side portion of the balloon-covered section. The outer diameter of the overlapping portion of the endpiece is configured to provide a stop to prevent the balloon catheter from being inserted into the guide tube sheath when the balloon protector covers the balloon.

[0019] In some embodiments, the endpiece includes a longitudinal gap on each of the two opposite sides of the balloon protector. The length of the longitudinal gap is greater than or equal to the length of the overlapping portion of the endpiece. The length of the longitudinal gap allows the distal portion of the bodypiece to be separated through the distal end of the bodypiece without increasing the applied peeling force.

[0020] In some implementations, the length of the longitudinal gap is greater than the length of the overlapping portion of the end member. Due to the length of the longitudinal gap, a through hole is formed between the distal end of the longitudinal gap and the distal end of the body member.

[0021] In some implementations, the through-hole is configured to provide an interruption in the applied peeling force when the balloon protector is separated along the balloon-covered section, the interruption indicating separation at the distal end through the body.

[0022] In some implementations, both the main body and the end pieces of the balloon coverage segment include pairs of opposing longitudinal weakening lines aligned with the flaps. The balloon coverage segment is configured to be separated along each of the weakening lines.

[0023] In some implementations, the balloon coverage segment further includes a transition segment configured to cover the proximal shoulder of the balloon. The transition segment has an outer diameter opening extending from the immediately adjacent distal portion of the balloon coverage segment to the distal end of the protruding segment. The outer diameter opening is configured to increase the distance between the flaps, making the flaps easier to grip.

[0024] In some implementations, each tab in the pair includes an inner surface and an outer surface. The inner and outer surfaces of each tab may optionally be textured to make the tab easier to grip.

[0025] In some embodiments, the balloon catheter also includes a bifurcated bushing around the proximal portion of the shaft. The bifurcated bushing has an expansion port of the balloon that is fluidly connected through an expansion lumen of the shaft.

[0026] This document also discloses a method for assembling a catheter assembly, in some embodiments of which the method includes a removal step of removing the catheter assembly from the catheter assembly kit. The catheter assembly can be any of the catheter assemblies described in paragraphs 13 to 23 above. For example, the catheter assembly includes a balloon catheter, a balloon protector, and a needle. The balloon catheter includes an axis having a guidewire lumen and a drug-coated balloon disposed in an uninflated state around a distal portion of the axis. The balloon protector can be any of the balloon protectors described in paragraphs 4 to 12 above. For example, the balloon protector includes a balloon covering section that covers the balloon. The balloon covering section includes an end piece of the balloon protector coupled to a distal portion of the body of the balloon protector. A needle is disposed within the guidewire lumen of the axis of the balloon catheter. The needle has a coiled distal portion extending from an opening in the distal end of the end piece of the balloon protector. The method also includes a pull step of pulling the needle out of the catheter assembly by coiling the distal portion. The method also includes a threading step of passing the proximal portion of the guidewire through an opening in the distal end of the balloon protector and into the guidewire lumen of the balloon catheter.

[0027] In some embodiments, the distal end of the balloon protector has a tapered portion with an inner diameter taper that matches the outer diameter of the distal shoulder of the balloon. The inner diameter taper of the distal end is configured to maintain concentricity between the opening at the distal end of the distal end of the distal end and the opening at the distal end of the balloon catheter's axis. Maintaining concentricity facilitates the insertion of the guidewire into the guidewire lumen of the balloon catheter.

[0028] In some implementations, the distal portion of the guidewire is positioned around the narrowed or blocked portion of the blood vessel in the patient’s blood vessel where balloon angioplasty is required.

[0029] In some embodiments, the method further includes a balloon catheter advancement step, advancing the balloon catheter over a guidewire to the narrowed or blocked portion of the vessel requiring balloon angioplasty. The method also includes an expansion step, inflating the balloon to widen the narrowed or blocked portion of the vessel. The balloon catheter includes a bifurcated bushing above a proximal portion of the shaft, the bifurcated bushing including an expansion port of the balloon fluidly connected through an expansion lumen of the shaft.

[0030] In some embodiments, the method further includes a catheter assembly advancement step of advancing the catheter assembly over the guidewire until an opening is formed in the proximal end of the guide sheath. The distal portion of the balloon protector has an overlapping portion over the distal portion of the body, the outer diameter of which is larger than the outer diameter of the immediately adjacent portion of the balloon-covered section. The overlapping portion is configured to prevent advancement of the catheter assembly into the guide sheath when the balloon protector covers the balloon.

[0031] In some embodiments, the method further includes a stripping step of detaching the balloon protector from the balloon catheter by progressively separating the balloon protector by successively pulling the paired tabs away from each other. The balloon protector includes a protruding section located proximal to the balloon-covered section, the protruding section comprising the pair of tabs.

[0032] In some implementations, both the body of the balloon protector and the end portion of the balloon coverage section include paired, opposing longitudinal weakening lines aligned with the flaps. The balloon coverage section is configured to be separated along each of the weakening lines.

[0033] These and other features of the concept provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which disclose specific embodiments of this concept in more detail. Attached Figure Description

[0034] Figure 1 A side view of a balloon protector according to some embodiments is shown.

[0035] Figure 2 A top or bottom view of a balloon protector according to some embodiments is shown.

[0036] Figure 3 A detailed side view of the distal portion of a balloon protector according to some embodiments is shown.

[0037] Figure 4 A detailed top or bottom view of the distal portion of a balloon protector according to some embodiments is shown.

[0038] Figure 5 A longitudinal cross-section of the distal portion of a balloon protector according to some embodiments is shown.

[0039] Figure 6 A transverse cross-section of the distal portion of a balloon protector according to some embodiments is shown, wherein the distal end piece overlaps with the distal portion of the body piece.

[0040] Figure 7 A transverse cross-section of the distal portion of the end piece of a balloon protector according to some embodiments is shown.

[0041] Figure 8 A balloon catheter according to some implementation schemes is shown.

[0042] Figure 9 A catheter assembly including a balloon catheter and a balloon protector is shown according to some embodiments.

[0043] Figure 10 A detailed side view of a catheter assembly including a core needle is shown according to some embodiments.

[0044] Figure 11 A detailed side view of an existing catheter assembly including a core needle is shown according to some embodiments. Detailed Implementation

[0045] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that allow them to be readily separable from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0046] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide for any order or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not need to appear in that order, and a particular embodiment including such features or steps does not need to be limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0047] The terms "proximal," "proximal portion," or "proximal section" for catheters, such as those disclosed herein, include the portion of the catheter intended to be close to the clinician when used with a patient. Similarly, the term "proximal length" for a catheter includes the length of the catheter intended to be close to the clinician when used with a patient. For example, the term "proximal end" for a catheter includes the end of the catheter intended to be close to the clinician when used with a patient. A proximal portion, proximal section, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal section, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise suggests, a proximal portion, proximal section, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0048] The terms "distal," "distal portion," or "distal part" of a catheter, as disclosed herein, include the portion of the catheter intended to be close to or within the patient when used in a patient. Similarly, the term "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when used in a patient. For example, the term "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used in a patient. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0050] In addition, balloon protectors are designed to cover and protect the drug-coated balloon of the balloon catheter during transport or preoperative handling, which is necessary to maintain the integrity of the balloon catheter for its intended surgical procedure. Furthermore, balloon protectors protect clinicians and others from unintentional contact with the antiproliferative drugs on the drug-coated balloon when handling the balloon catheter prior to the surgical procedure. While the aforementioned needs for balloon protectors persist, additional needs exist, such as the need to prevent the balloon catheter from advancing through the guide tube sheath without first removing its balloon protector.

[0051] This article discloses balloon protectors that meet or exceed the above requirements, including balloon catheters for balloon protectors and methods thereof.

[0052] balloon protector

[0053] Figure 1 and Figure 2 Side and top or bottom views of a balloon protector 100 according to some embodiments are shown. Figure 3 and Figure 4Detailed side and top or bottom views of the distal portion of a balloon protector 100 according to some embodiments are shown. Figure 5 A longitudinal cross-section of the distal portion of the balloon protector 100 is shown; Figure 6 A transverse cross-section of the distal portion of the balloon protector is shown, wherein the distal portion 104 overlaps with the distal portion of the main body 102; and Figure 7 A transverse cross-section of the distal portion of the end piece 104 of a balloon protector 100 according to some embodiments is shown.

[0054] Balloon protector 100 is configured to cover and protect the balloon catheter during transport or preoperative treatment (e.g., Figure 8 The balloon catheter (800) is coated with a drug-coated balloon, which is necessary to maintain the integrity of the balloon catheter for use in the surgical procedure it is designed for.

[0055] As shown in the figure, the balloon protector 100 includes a body 102 and an end piece 104 coupled to the distal portion of the body 102. Each component of the body 102 and the end piece 104 is integral because it is a continuous component. The balloon coverage section 106 of the balloon protector 100 includes the end piece 104 and the distal portion of the body 102. The balloon coverage section 106 also includes a transition section 108 of the body 102 opposite to the end piece 104. The protruding section 110 of the balloon protector 100 includes the proximal portion of the body 102.

[0056] The balloon covering section 106 is configured to cover the balloon of a balloon catheter, which is typically arranged around the distal portion of the balloon catheter's axis. The balloon covering section 106 is configured to cover the balloon of such a balloon catheter with at least a clearance fit (e.g., sliding fit, position fit, etc.) up to a transition fit (e.g., tight fit), thereby holding the balloon in an uninflated folded configuration without compressing it to a minimum. With respect to the clearance fit, the inner diameter of the balloon covering section 106 of the balloon protector 100 is as small as possible larger than the outer diameter of the balloon in the uninflated folded configuration. With respect to the transition fit, the inner diameter of the balloon covering section 106 is negligibly larger than the outer diameter of the balloon in the uninflated folded configuration. (For this tolerance, see International Organization for Standardization [“ISO”] 2768).

[0057] The distal end 104 of the balloon protector 100 is configured to cover the distal shoulder of the balloon of the balloon catheter, which typically does not include a drug coating. The distal end 104 is coupled (e.g., by adhesion, solvent bonding, thermal welding, etc.) to the distal portion of the body 102 of the balloon protector 100 such that the distal end 104 has an overlap 112 over the distal portion of the body 102. The outer diameter of the overlap 112 is larger than the outer diameter of the immediately adjacent portion of the balloon-covered section 106 of the balloon protector 100. The outer diameter of the overlap 112 of the distal end 104 is configured to provide a stop to prevent the balloon catheter from being inserted into the guide tube sheath when the balloon protector 100 covers the balloon. The advantage of this stop is that the balloon protector is preferably left above the balloon of the balloon catheter until the moment the balloon catheter is inserted into the guide tube sheath, thus protecting the balloon from fluids (e.g., saline, body fluids, etc.), wet instruments, wet hands, etc. The stopper allows clinicians to leave the balloon protector of the desired length above the balloon of the balloon catheter without the risk of inadvertently inserting the balloon catheter into the guide tube sheath when the balloon protector 100 covers the balloon.

[0058] The distal end 104 has a tapered portion 114 that tapers gradually from the overlapping portion 112 of the distal end 104 towards its distal end 116. The tapered portion 114 of the distal end 104 has an inner diameter taper that corresponds to the outer diameter of the distal shoulder of the balloon catheter. The inner diameter taper of the tapered portion 114 is configured to maintain concentricity between the opening 118 in the distal end 116 and the opening in the distal end of the balloon catheter axis for the guidewire to pass through. The tapered portion 114 also has an outer diameter taper. Depending on the outer diameter of the overlapping portion 112 of the distal end 104, the length of the distal end 104, etc., the outer diameter taper may be greater than, equal to, or less than the inner diameter taper. The outer diameter taper is greater than... Figure 5 The inner diameter taper of the balloon protector 100 embodiment shown. As described below, the end piece 104 and its tapered portion 114 facilitate the removal of the core needle.

[0059] The distal end piece 104 includes longitudinal gaps 120 on each of the two opposite sides of the balloon protector 100. As measured from the proximal end of the distal end piece 104, the length of the longitudinal gaps 120 of the distal end piece 104 is equal to or greater than the length of the overlapping portion 112 of the distal end piece 104. The length of the longitudinal gaps 120 allows the distal portion of the body piece 102 of the balloon protector 100 to be separated at its distal end without increasing the applied peeling force that would otherwise require separating both the overlapping portion 112 of the distal end piece 104 and the distal portion of the body piece 102. At least Figure 1 , Figure 3 and Figure 5In the embodiment of the balloon protector 100 shown, the length of the longitudinal gap 120 is greater than the length of the overlapping portion 112. In this embodiment, a window or through-hole 121 is formed between the distal end of the longitudinal gap 120 and the distal end of the body member 102. When the balloon protector 100 is separated in the distal direction along the balloon coverage section 106, the through-hole 121 advantageously provides an instantaneous interruption of the applied peeling force (e.g., ~1.5 lbf to 0 lbf). This interruption indicates that separation has penetrated the distal end of the body member 102, which in turn indicates that separation beginning with the distal end member 104 is nearing completion.

[0060] The transition section 108 of the balloon protector 100 is configured to cover the proximal shoulder of the balloon of the balloon catheter, which typically does not include the drug coating. The transition section 108 has an opening at least on its outer diameter extending from the immediately distal portion of the balloon covering section 106 of the balloon protector 100 to the distal end of the protruding section 110 of the balloon protector 100. The opening of the transition section 108 is configured to increase the distance between each of the paired tabs 122 of the protruding section 110 of the balloon protector 100, thereby making the tabs 122 easier to grip when the balloon protector 100 is open. The opening of the transition section 108 is also configured to facilitate the manufacture of catheter assemblies, such as the catheter assembly 900 described below. In effect, the opening of the transition section 108 ensures that the drug coating 833 of the balloon 832 is not unnecessarily scraped off when the balloon protector 100 is positioned over the balloon 832. In addition, the transition section 108 minimizes any potential damage to the balloon 832 when it is not inflated.

[0061] The protruding section 110 of the balloon protector 100 includes a pair of tabs 122 configured to provide a starting point from which the balloon-covering section 106 of the balloon protector 100 is separated along multiple pairs of weakening lines 124 and 126, as described below. In practice, the tabs 122 are configured to be gripped and continuously pulled away from each other to progressively separate the balloon protector 100 in a distal direction along the balloon-covering section 106 of the balloon protector 100 until the balloon protector 100 is completely detached from the balloon of the balloon catheter. Similar to the opening of the transition section 108 of the balloon protector 100, the protruding section 110 has an opening configured to increase the distance between each of the tabs 122 of the protruding section 110, thereby making the tabs 122 easier to grip for separating the balloon protector 100. Additionally, each of the tabs 122 includes an inner surface and an outer surface. Either the inner or outer surface of each tab, or both surfaces of each tab, may be textured to make the tabs 122 easier to grip for disengaging the balloon protector 100. At least in Figure 1 , Figure 2 and Figure 9In the embodiment of the balloon protector 100 shown, the inner and outer surfaces of each of the tabs 122 are textured.

[0062] The body 102 of the balloon coverage section 106 of the balloon protector 100 includes a pair of opposing longitudinal weakening lines 124 aligned with the tab 122, the body 102 being configured to be separated along the longitudinal weakening lines. Similarly, the distal end 104 of the balloon coverage section 106 of the balloon protector 100 includes a pair of opposing longitudinal weakening lines 126 aligned with the tab 122, the distal end 104 being configured to be separated along the longitudinal weakening lines. Notably, each weakening line 124 of the body 102 extends from the distal end of the body 102 into the longitudinal gap 120 of the distal end 104. Each weakening line 126 of the distal end 104 extends from the distal end of the longitudinal gap 120 of the distal end 104 through the distal end of the distal end 116 of the distal end 104. If a through-hole 121 is present on each side of the balloon protector 100, the through-hole provides a break between the weakening lines 124 and 126. The weakening lines 124 and 126 may be indentations or perforations along the balloon coverage section 106, wherein the perforations include a series of longitudinal slits resembling dashed lines, a series of through-holes resembling dotted lines, or a combination thereof.

[0063] In an alternative to the above, the body 102 of the balloon protector 100 lacks the pair of weakening lines 124, the distal part 104 of the balloon protector 100 lacks the pair of weakening lines 126, or both the body 102 and the distal part 104 lack their respective pairs of weakening lines. Alternatively, depending on the specific circumstances, each component of the body 102, the distal part 104, or both the body 102 and the distal part 104 is formed of a polymer material, wherein the main chain of the polymer material is oriented along the length of the body 102 or the distal part 104. The main chains of the polymer material are configured to easily separate from the starting point provided by, for example, the pair of tabs 122, through the remainder of the body 102 or the distal part 104 when pulled away from each other, without laterally tearing the body 102 or the distal part 104.

[0064] Each component of the body 102 and the end piece 104 of the balloon protector 100 may be made of a polymer material, including but not limited to high-density polyethylene (“HDPE”) or expanded polytetrafluoroethylene (“ePTFE”). When the body 102 or the end piece 104 is made of ePTFE, the main chain of ePTFE may be oriented along the length of the body 102 or the end piece 104 to facilitate separation without the pair of weakening lines 124 or 126 as described above. When the body 102 or the end piece 104 is molded from a polymer material, the body 102 or the end piece 104 has the characteristics of the molding process used, such as injection molding, extrusion molding, compression molding, bladder molding, etc.

[0065] catheter assembly

[0066] Figure 8 A balloon catheter 800 according to some embodiments is shown. Figure 9 A catheter assembly 900 including a balloon catheter 800 and a balloon protector 100 is shown according to some embodiments. Figure 10 A detailed side view of a catheter assembly 900 including a needle 928 according to some embodiments is shown.

[0067] The catheter assembly 900 includes a balloon catheter 800, a balloon protector 100, and optionally, a core needle 928 to maintain the integrity of the catheter assembly 900 during transport or preoperative treatment.

[0068] The balloon catheter 800 includes a shaft 830, a balloon 832 arranged in an uninflated state around a distal portion of the shaft 830, and a bifurcated bushing 834 around a proximal portion of the shaft 830.

[0069] The balloon 832 of the balloon catheter 800 may be a drug-coated balloon, wherein the drug coating 833 of the balloon 832 is a coating of an antiproliferative or antirestenotic drug (such as paclitaxel or rapamycin). The balloon 832 includes a proximal shoulder 836 and a distal shoulder 838, between which the drug coating 833 of the balloon 832 is typically applied. That is, the proximal shoulder 836 and distal shoulder 838 of the balloon 832 typically do not include the drug coating 833. This is because the proximal shoulder 836 and distal shoulder 838 are typically not juxtaposed with the arterial lumen wall during surgical procedures for atherosclerosis. However, as described above, in some embodiments, the balloon 832 does not need to include the drug coating 833.

[0070] The bifurcation bushing 834 has an expansion port 840 of the balloon 832 of the balloon catheter 800 fluidly connected to the expansion lumen of the balloon catheter 800 through the shaft 830. The bifurcation bushing 834 also has a guidewire port 842 connected to the guidewire lumen 844, which extends along the entire length of the shaft 830 to an opening in the distal end of the shaft 830. Figure 9 and Figure 10 A core needle 928 is shown within at least the distal portion of the guidewire lumen 844 of shaft 830.

[0071] The balloon protector 100 is described as described above, including details of the construction of the balloon protector 100 above the balloon of a balloon catheter (e.g., balloon catheter 800), and details of how the balloon protector 100 is configured to be removed from such a balloon catheter.

[0072] When present in the catheter assembly 900, a needle 928 is disposed within both the distal end 104 of the balloon protector 100 and the guidewire lumen 844 of the shaft 830 of the balloon catheter 800 to maintain the integrity of the catheter assembly 900 during its transport or preoperative treatment, for example, to prevent collapse of the guidewire lumen 844 of the shaft 830. The needle 928 may be metal (e.g., stainless steel) and has a coiled distal portion extending from an opening in the distal end 116 of the distal end 104 of the balloon protector 100 configured to prevent irreversible slippage of the needle 928 into the guidewire lumen 844 of the shaft 830. The coiled distal portion of the needle 928 is also configured to provide a handle for grasping the needle 928 and pulling it out of the catheter assembly 900 before use.

[0073] like Figure 10 and Figure 11 As the comparison shows, the distal part 104 of the balloon protector 100 and its tapered portion 114 advantageously facilitate gripping the needle 928 and pulling it out of the catheter assembly 900, which is useful for, for example... Figure 11 This can be difficult for catheter components. For example, Figure 11 The catheter assembly has a balloon protector with an open distal portion, rather than a tapered distal portion like balloon protector 100. The coiled distal portion of the needle 928 can be coiled into and concealed within the open distal portion of the balloon protector of the catheter assembly, making it difficult to grasp and pull the needle 928 from the catheter assembly. However, due to the configuration of the end piece 104, the coiled distal portion of the needle 928 remains exposed, thus facilitating the grasping and pulling of the needle 928 from the catheter assembly 900.

[0074] The catheter assembly 900 can be aseptically packaged and ready for immediate use.

[0075] method

[0076] The method of using the catheter assembly 900 includes the method of using the catheter assembly 900.

[0077] For example, a method of using catheter assembly 900 includes a removal step of removing catheter assembly 900 from a kit including catheter assembly 900. For the purposes of this example method, catheter assembly 900 includes balloon catheter 800, balloon protector 100, and needle 928. Balloon catheter 800 includes shaft 830 having guidewire lumen 844 and balloon 832 arranged in an uninflated state around a distal portion of shaft 830. Balloon 832 includes a drug coating 833 thereon. Balloon protector 100 includes a balloon covering section 106 covering balloon 832. Balloon covering section 106 includes an end piece 104 of balloon protector 100 coupled to a distal portion of body piece 102 of balloon protector 100. Needle 928 is arranged in the guidewire lumen 844 of shaft 830 of balloon catheter 800 to maintain the integrity of catheter assembly 900 during transport or preoperative treatment. The needle 928 has a wound distal portion extending from an opening in the distal end 116 of the distal end member 104 of the balloon protector 100.

[0078] The method includes a pull-out step that removes the needle 928 from the catheter assembly 900 after a removal step. The pull-out step includes pulling the needle 928 out of the catheter assembly 900 through the wound distal portion of the needle 928.

[0079] The method includes a threading step of passing the proximal portion of the guidewire through an opening in the distal end 116 of the distal part 104 of the balloon protector 100 and into the guidewire lumen 844 of the balloon catheter 800. The distal portion of the guidewire is typically already positioned in the patient's blood vessel around the narrowed or blocked portion of the vessel where balloon angioplasty is required.

[0080] Although not explicitly shown, Figure 10 and Figure 11 The contrast suggests how the end piece 104 of the balloon protector 100 and its tapered portion 114 advantageously facilitate the threading process, which is, for example... Figure 11 This can be difficult for catheter components. As mentioned above, Figure 11The catheter assembly has a balloon protector with an open distal portion, rather than a tapered distal portion like balloon protector 100. The open distal portion of the balloon protector can conceal the distal portion of the balloon catheter shaft and the opening of its guidewire lumen, making threading difficult and requiring multiple back-and-forth punctures. In practice, clinicians often remove this balloon protector before attempting to perform threading, risking exposure of the balloon catheter's balloon to fluids (e.g., saline, body fluids, etc.), wet instruments, wet hands, etc. However, due to the construction of the endpiece 104, the opening 118 in the distal end 116 of the endpiece 104 remains exposed, facilitating the threading step (i.e., passing the proximal portion of the guidewire through the opening 118 in the distal end 116 of the endpiece 104 of the balloon protector 100 and into the guidewire lumen 844 of the balloon catheter 800). Of course, the tapered portion 114 of the end piece 104 has an inner diameter taper that matches the outer diameter of the distal shoulder 838 of the balloon 832. This maintains the concentricity between the opening 118 in the distal end 116 of the end piece 104 and the opening in the distal end of the axis 830 of the balloon catheter 800, thereby further facilitating the threading step.

[0081] The method includes a catheter assembly advancement step of advancing the catheter assembly 900 over the guidewire until an opening is formed in the proximal end of the guide sheath. As described above, the distal part 104 of the balloon protector 100 has an overlapping portion 112 over the distal portion of the body 102 of the balloon protector 100, the outer diameter of which is larger than the outer diameter of the immediately adjacent side portion of the balloon-covered section 106 of the balloon protector 100. The overlapping portion 112 is configured to prevent advancement of the catheter assembly 900 into the guide sheath when the balloon protector 100 covers the balloon 832.

[0082] The method includes a stripping step of peeling the balloon protector 100 from the balloon catheter 800 by progressively pulling the paired tabs 122 of the protruding section 110 of the balloon protector 100 away from each other to gradually separate the balloon protector 100. As described above, both the body 102 and the distal end 104 of the balloon covering section 106 of the balloon protector 100 include multiple pairs of weakening lines 124 and 126 aligned with the tabs 122. The balloon covering section 106 is configured to be separated along each of the weakening lines 124 and 126.

[0083] The method may also include a balloon catheter advancement step above the guidewire, advancing the balloon 832 of the balloon catheter 800 to the stenotic or occluded portion of the blood vessel requiring balloon angioplasty.

[0084] The method may include an inflation step of inflating a balloon 832 to widen a narrow or blocked portion of a blood vessel. As described above, the balloon catheter 800 includes a bifurcated bushing 834 above a proximal portion of a shaft 830, the bifurcated bushing including an inflation port 840 fluidly connected to the balloon 832 through an inflation lumen of the shaft 830 for the inflation step.

[0085] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A balloon protector comprising: a balloon covering segment configured to cover a drug-coated balloon of a balloon catheter, the balloon covering segment including a tip piece of the balloon protector, the tip piece coupled to a distal end portion of a body piece of the balloon protector; and a tabbed segment proximal of the balloon covering segment, the tabbed segment including a pair of tabs configured to be continuously pulled away from each other to progressively separate the balloon protector along the balloon covering segment until the balloon protector is completely stripped from the balloon, wherein the tip piece has a tapered portion having an inner diameter taper that conforms to an outer diameter of a distal shoulder of the balloon, the inner diameter taper of the tip piece configured to maintain concentricity between an opening in a distal end of the tip piece and an opening in a distal end of a shaft of the balloon catheter so as to pass a guidewire therethrough.

2. The balloon protector of claim 1, wherein the tip piece has an overlapping portion over the distal end portion of the body piece, an outer diameter of the overlapping portion being greater than an outer diameter of an immediately proximal portion of the balloon covering segment, the outer diameter of the overlapping portion of the tip piece configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon.

3. The balloon protector of claim 2, wherein the tip piece includes a longitudinal gap on each of two opposing sides of the balloon protector, a length of the longitudinal gap being greater than or equal to a length of the overlapping portion of the tip piece, thereby allowing the distal end portion of the body piece to be separated through the distal end of the body piece without increasing an applied stripping force.

4. The balloon protector of claim 3, wherein the length of the longitudinal gap is greater than the length of the overlapping portion of the tip piece, thereby forming a through-hole between a distal end of the longitudinal gap and the distal end of the body piece.

5. The balloon protector of claim 4, wherein the through-hole is configured to provide an interruption in the applied stripping force when separating the balloon protector along the balloon covering segment, the interruption indicating separation through the distal end of the body piece.

6. The balloon protector of claim 1, wherein the body piece and the tip piece of the balloon covering segment each include a pair of opposing longitudinal lines of weakness aligned with the tabs, the balloon covering segment configured to separate along each of the lines of weakness.

7. The balloon protector of claim 1, the balloon covering segment further comprising a transition segment configured to cover a proximal shoulder of the balloon, the transition segment having an outer diameter flare from an immediately distal portion of the balloon covering segment to a distal end of the tabbed segment, the outer diameter flare configured to increase a distance between the tabs so that the tabs are more easily graspable.

8. The balloon protector of claim 1, wherein each tab of the pair of tabs includes an inner surface and an outer surface, the inner surface and the outer surface of each tab having a texture so that the tabs are more easily graspable. ​ 9. A catheter assembly comprising: a balloon catheter comprising: a shaft; and a drug coated balloon disposed in an un-inflated state about a distal end portion of the shaft; and a balloon protector comprising: a balloon covering segment covering the balloon, the balloon covering segment comprising a tip piece of the balloon protector coupled to a distal end portion of a body piece of the balloon protector; and a tabbed segment proximal of the balloon covering segment, the tabbed segment comprising a pair of tabs configured to be continuously pulled away from each other to progressively separate the balloon protector along the balloon covering segment until the balloon protector is completely stripped from the balloon, wherein the tip piece has a tapered portion having an inner diameter taper that conforms to an outer diameter of a distal shoulder of the balloon, the inner diameter taper of the tip piece configured to maintain concentricity between an opening in a distal end of the tip piece and an opening in a distal end of the shaft of the balloon catheter so as to pass a guidewire therethrough.

10. The catheter assembly of claim 9, further comprising a stylet disposed in a guidewire inner lumen of the shaft of the balloon catheter to maintain integrity of the catheter assembly during shipping or pre-operative handling, the stylet having a coiled distal end portion extending from the opening in the distal end of the tip piece of the balloon protector, the coiled distal end portion configured to be grasped so as to pull the stylet out of the catheter assembly.

11. The catheter assembly of claim 9, wherein the tip piece has an overlapping portion over the distal end portion of the body piece, an outer diameter of the overlapping portion being greater than an outer diameter of an immediately proximal portion of the balloon covering segment, the outer diameter of the overlapping portion of the tip piece configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon.

12. The catheter assembly of claim 11, wherein the tip piece comprises a longitudinal gap on each of two opposing sides of the balloon protector, a length of the longitudinal gap being greater than or equal to a length of the overlapping portion of the tip piece, thereby allowing the distal end portion of the body piece to be separated through the distal end of the body piece without increasing an applied stripping force.

13. The catheter assembly of claim 12, wherein the length of the longitudinal gap is greater than the length of the overlapping portion of the tip piece, thereby forming a through hole between a distal end of the longitudinal gap and the distal end of the body piece.

14. The catheter assembly of claim 13, wherein the through hole is configured to provide an interruption in the applied stripping force when separating the balloon protector along the balloon covering segment, the interruption indicating separation through the distal end of the body piece.

15. The catheter assembly of claim 9, wherein the body piece and the tip piece of the balloon covering segment each comprise a pair of opposing longitudinal lines of weakness aligned with the tabs, the balloon covering segment configured to separate along each of the lines of weakness.

16. The catheter assembly of claim 9, the balloon covering segment further comprising a transition segment configured to cover a proximal shoulder of the balloon, the transition segment having an outer diameter flare from an immediately distal portion of the balloon covering segment to a distal end of the tab segment, the outer diameter flare configured to increase a distance between the tabs such that the tabs are more easily graspable.

17. The catheter assembly of claim 9, wherein each tab of the pair of tabs comprises an inner surface and an outer surface, the inner surface and the outer surface of each tab having a texture such that the tabs are more easily graspable.

18. The catheter assembly of claim 9, wherein the balloon catheter further comprises a bifurcated hub surrounding a proximal end portion of the shaft, the bifurcated hub having an inflation port fluidly connected to the balloon through an inflation lumen of the shaft.

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