BALL PROTECTORS, BALLOON CATHETER SETS AND METHODS THEREOF

Abstract

This document describes balloon protectors, balloon catheters including balloon protectors, and methods for their use. The balloon protector may include a section covering the balloon and a section with tabs proximal to the balloon-covering section. The balloon-covering section may be configured to cover a drug-coated balloon of the balloon catheter. The balloon-covering section may include a balloon protector tip piece attached to a distal end portion of a balloon protector body piece. The tabbed section includes a pair of tabs configured to continuously separate from each other to progressively divide the balloon protector along the balloon-covering section until the balloon protector is completely detached from the balloon.Beneficially, an outer diameter of the tip piece can provide a stop to prevent the insertion of a balloon catheter into an introducer sheath while the balloon protector covers a balloon from the balloon protector.

Description

BALLOON PROTECTORS, BALLOON CATHETER ASSEMBLY AND METHODS THEREOF PRIORITY This application claims the benefit of priority to U.S. Patent Application No. 62 / 969,900, filed on February 4, 2020, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION Atherosclerosis is characterized by one or more intravascular lesions formed within the portion of the plaque that contains blood-borne substances such as fat, cholesterol, and calcium. An intravascular lesion, such as an arterial lesion, can form within the wall of an arterial lumen and grow through the lumen to an opposite wall. Often, a final point of permeability occurs at the boundary between the arterial lesion and the opposite wall of the arterial lumen. Surgical procedures for atherosclerosis, such as balloon angioplasty with drug-coated balloons, can be used to restore patency and blood flow lost due to one or more intravascular lesions. Balloon protectors are designed to cover and protect the drug-coated balloons of balloon catheters during shipping or preoperative handling. This is necessary to maintain the integrity of the balloon catheters for the surgical procedures for which they are designed. Additionally, balloon protectors protect clinicians and others from inadvertently coming into contact with the antiproliferative drugs in the drug-coated balloons when handling the balloon catheters prior to surgical procedures. While the aforementioned need for balloon protectors remains, additional needs have emerged, such as the need to protect against advancing a balloon catheter through an introducer sheath without first removing the balloon protector. This document describes balloon protectors, balloon catheters including balloon protectors, and methods thereof that meet the above needs. BRIEF DESCRIPTION OF THE INVENTION This document describes a balloon protector for a balloon catheter. The balloon protector may include a section that covers the balloon and a section with tabs. Rcafinn / zznz / e / YiAi proximal to the balloon-covering section. The balloon-covering section can be configured to cover a drug-coated balloon of the balloon catheter. The balloon-covering section includes a balloon protector tip piece attached to a distal end portion of a balloon protector body piece. The tabbed section includes a pair of tabs configured to continuously separate from each other to progressively divide the balloon protector along the balloon-covering section until the balloon protector is completely peeled away from the balloon. In some designs, the tip piece has a tapered portion with a tapered inner diameter (configured to be) proportional to the outer diameter of a distal flange of the balloon. The taper of the tip piece's inner diameter is configured to maintain concentricity between an opening at a distal end of the tip piece and an opening at a distal end of a balloon catheter shaft for passing a guidewire through it. In some designs, the tip piece has an overlapping portion over the distal end portion of the body piece. In other words, the overlapping portion partially overlaps the distal end portion of the body piece. The overlapping portion has a larger outside diameter than the immediately proximal portion of the balloon-covering section. The outside diameter of the overlapping tip piece is configured to provide a stop to prevent the insertion of a balloon catheter into an introducer sheath while the balloon cover is covering a balloon. In some forms, the toe piece includes a longitudinal gap on each side of two opposite sides of the ball protector. The longitudinal gap is equal to or greater than the length of the overlapping portion of the toe piece. The ball protector is configured so that the length of the longitudinal gap allows the distal end portion of the body piece to split through a distal end of the body piece without increasing the applied breakaway force. In some variations, the length of the longitudinal space is greater than that of the overlapping portion of the toe piece. Because of the length of the longitudinal space, the ball protector is configured so that a through-hole is formed between a distal end of the longitudinal space and the distal end of the body piece. In some modalities, the ball protector is configured so that the hole through which it is passed is configured to provide an interruption in the peel force applied when splitting the ball protector along the section covering the ball, indicating the interruption by splitting through the distal end of the body piece. In some variations, both the body and tip pieces of the ball-covering section include a pair of opposing longitudinal weak lines aligned with the tabs. The ball protector is configured so that the ball-covering section is split along each of these weak lines. RPQfinn / zznz / e / YiAi In some models, the balloon-covering section also includes a transition section designed to cover a proximal rim of the balloon. The transition section has an outer diameter widening from a distal portion (immediately) of the balloon-covering section to a distal end of the tabbed section. This outer diameter widening is designed to increase the distance between the tabs. This is optional to facilitate gripping the tabs. In some models, each tongue of the pair includes an inner and an outer surface. The inner and outer surfaces of each tongue have an optional texture. This is optional to improve grip on the tongues. A catheter assembly is also described here. The catheter assembly includes, in some modalities, a balloon catheter and a balloon protector. The balloon catheter includes a shaft and a drug-coated balloon in a deflated state arranged around a distal end portion of the shaft. The balloon protector may be the balloon protector of any of the preceding paragraphs

[0004] through

[0012] . For example, the balloon protector may include a balloon-covering section and a section with tabs proximal to the balloon-covering section. The balloon-covering section covers a balloon of the balloon catheter. The balloon-covering section includes a balloon protector tip piece attached to a distal end portion of a balloon protector body piece.The tabbed section includes a pair of tabs configured to continuously separate from each other to progressively split the ball protector along the section covering the ball until the ball protector is completely peeled away from the ball. In some designs, the tip piece has a tapered portion with a tapered inner diameter proportional to the outer diameter of a distal flange of the balloon. The taper of the tip piece's inner diameter is configured to maintain concentricity between an opening at the distal end of the tip piece and an opening at the distal end of a balloon catheter shaft for passing a guidewire through it. In some configurations, the catheter assembly also includes a stylet positioned within a guidewire lumen of the balloon catheter shaft, such that the catheter assembly is configured to maintain its integrity during shipping or preoperative handling. The stylet has a coiled distal end portion extending from the opening at the distal end of the balloon shield tip piece, configured to be grasped for withdrawing the stylet from the catheter assembly. In some designs, the tip piece has an overlapping portion over the distal end portion of the body piece. The overlapping portion has a larger outside diameter than the immediately proximal portion of the balloon-covering section. The outside diameter of the tip piece's overlapping portion is configured to provide a stop to prevent the insertion of a balloon catheter into an introducer sheath while the balloon cover is in place. Rcafinn / zznz / e / YiAi In some variations, the tip piece includes a longitudinal gap on each side of two opposite sides of the ball protector. The longitudinal gap is equal to or greater than the length of the overlapping portion of the tip piece. The length of the longitudinal gap allows the distal end portion of the body piece to split through a distal end of the body piece without increasing the applied breakaway force. In some models, the length of the longitudinal space is greater than that of the overlapping portion of the tip piece. Due to the length of the longitudinal space, a through-hole is formed between a distal end of the longitudinal space and the distal end of the body piece. In some modalities, the through-hole is configured to provide an interruption in the peel force applied when splitting the ball protector along the section covering the ball, indicating the interruption of the split through the distal end of the body piece. In some variations, both the body piece and the tip piece of the ball-covering section include a pair of opposing longitudinal weak lines aligned with the tabs. The ball-covering section is configured to split along each of these weak lines. In some models, the section covering the balloon also includes a transition section designed to cover a proximal rim of the balloon. This transition section has an outer diameter widening from a distal portion immediately adjacent to the balloon-covering section to a distal end of the tabbed section. This widening is designed to increase the distance between the tabs, making them easier to grip. In some models, each tongue of the pair includes an inner and an outer surface. The inner and outer surfaces of each tongue are optionally textured, making the tongues easier to grip. In some models, the balloon catheter also includes a bifurcated connector around a proximal portion of the shaft. The bifurcated connector has an inflation port fluidly connected to the balloon via an inflation lumen in the shaft. Also described herein is a method for a catheter assembly that includes, in some embodiments, an extraction step for removing the catheter assembly from a catheter assembly package. The catheter assembly may be a catheter assembly of any of the preceding paragraphs

[0013] through

[0023] . For example, the catheter assembly includes a balloon catheter, a balloon shield, and a stylet. The balloon catheter includes a shaft having a guidewire lumen and a drug-coated balloon in a deflated state disposed around a distal end portion of the shaft. The balloon shield may be a balloon shield of any of the preceding paragraphs

[0004] through

[0012] . For example, the balloon shield includes a balloon-covering section. The balloon-covering section includes a RPQfinn / zznz / e / YiAi A balloon shield tip piece is attached to a distal end portion of a balloon shield body piece. The stylet is disposed in the lumen of the balloon catheter shaft guidewire. The stylet has a coiled distal end portion extending from the opening in the distal tip of the balloon shield tip piece. The method also includes a withdrawal step in which the stylet is withdrawn from the catheter assembly by the coiled distal end portion. The method also includes a step of threading a proximal end portion of a guidewire through the opening in the distal end of the balloon shield tip piece and into the lumen of the balloon catheter guidewire. In some designs, the balloon protector tip piece has a tapered portion with a tapered inner diameter proportional to the outer diameter of a distal flange of the balloon. The taper of the tip piece's inner diameter is configured to maintain concentricity between an opening at the distal end of the tip piece and an opening at the distal end of a balloon catheter shaft. Maintaining concentricity facilitates threading the guidewire into the lumen of the balloon catheter guidewire. In some modalities, a distal end portion of the guide wire is placed in a patient's blood vessel around a narrowed or blocked portion of the blood vessel that needs balloon angioplasty. In some modalities, the method also includes a balloon catheter advancement step to move the balloon catheter over the guidewire to the narrowed or obstructed portion of the blood vessel requiring balloon angioplasty. The method also includes an inflation step to inflate the balloon to widen the narrowed or obstructed portion of the blood vessel. The balloon catheter includes a bifurcated connector on a proximal end portion of the shaft that includes an inflation port fluidly connected to the balloon via an inflation lumen in the shaft. In some modalities, the method includes a catheter assembly advancement step consisting of advancing the catheter assembly over the guidewire to an opening at the proximal end of an introducer sheath. The tip piece of the balloon protector has an overlapping portion over the distal end portion of the body piece with a larger outside diameter than the immediately adjacent portion of the section covering the balloon. The overlapping portion is configured to arrest the advancement of the catheter assembly into the introducer sheath with the balloon protector covering the balloon. In some variations, the method also includes a detachment step, which involves separating the balloon protector from the balloon catheter by continuously pulling a pair of tabs apart to progressively divide the balloon protector. The balloon protector includes a tabbed section adjacent to the section covering the balloon, which also includes the pair of tabs. In some variations, both the body piece and the tip piece of the ball-covering section of the ball protector include a pair of weak longitudinal lines. Rcafinn / zznz / e / YiAi opposite aligned with the tabs. The section covering the ball is configured to split along each line of the weak lines. These and other features of the concepts provided in this document will become more evident to those skilled in the art in view of the accompanying drawings and the following description, which describe in greater detail the particular modalities of such concepts. DRAWINGS Figure 1 illustrates a side view of a ball protector according to some modalities. Figure 2 illustrates a top and bottom view of the ball protector according to some modalities. Figure 3 illustrates a detailed side view of a distal portion of a ball protector according to some modalities. Figure 4 illustrates a detailed top or bottom view of the distal end portion of the ball protector according to some modalities. Figure 5 illustrates a longitudinal cross-section of the distal end portion of the ball protector according to some modalities. Figure 6 illustrates a cross-section of the distal end portion of the ball protector where a tip piece overlaps a distal end portion of a body piece according to some modalities. Figure 7 illustrates a cross-section of a distal end portion of the ball protector tip piece according to some modalities. Figure 8 illustrates a balloon catheter according to some modalities; Figure 9 illustrates a catheter assembly that includes the balloon catheter and balloon protector according to some modalities. Figure 10 illustrates a detailed side view of the catheter assembly including a stylet according to some modalities. Figure 11 illustrates a detailed side view of an existing catheter assembly that includes a stylet according to some modalities. DETAILED DESCRIPTION OF THE INVENTION Before some particular modalities are described in greater detail, it should be understood that the particular modalities described herein do not limit the scope of the concepts provided. It should also be understood that a particular modality described herein may have features that can be easily separated from the particular modality and, optionally, combined with or replaced by features of any of several other modalities described herein. Regarding the terms used in this document, it should also be understood that the terms are for the purpose of describing certain modalities, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide a numerical or sequential limitation. For example, the first, second, and third features or steps do not necessarily have to appear in that order, and the particular modalities that include such features or steps are not necessarily limited to those three features or steps. Labels such as left, right, front, back, top, bottom, proximal, distal, and the like are used for convenience and are not intended to imply, for example, any fixed location, orientation, or direction.Instead, these labels are used to reflect, for example, location, orientation, or relative directions. The singular terms a, an, and the include plural references unless the context clearly dictates otherwise. With respect to proximal, a proximal portion or proximal end portion of, for example, a catheter described herein includes a portion of the catheter intended to be near a clinician when the catheter is used in a patient. Likewise, a proximal length of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used in the patient. A proximal end of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used in the patient. The proximal portion, proximal end portion, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of the catheter need not include the proximal end of the catheter.In other words, unless the context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or a terminal length of the catheter. With respect to "distal," a distal portion or distal end portion of, for example, a catheter described herein includes a portion of the catheter intended to be near or in a patient when the catheter is used in the patient. Similarly, a distal length of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used in the patient. A distal end of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used in the patient. The distal portion, distal end portion, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter.That is, unless the context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or a terminal length of the catheter. RPQfinn / zznz / e / YiAi Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Again, balloon protectors are designed to cover and protect the drug-coated balloons of balloon catheters during shipping or preoperative handling, which is necessary to maintain the integrity of the balloon catheters for the surgical procedures for which they are designed. Additionally, balloon protectors protect clinicians and others from inadvertently coming into contact with the antiproliferative drugs in the drug-coated balloons when handling the balloon catheters prior to surgical procedures. While the aforementioned need for balloon protectors remains, there are additional needs, such as the need to protect against advancing a balloon catheter through an introducer sheath without first removing the balloon protector. This document describes balloon protectors, balloon catheters including balloon protectors, and methods thereof that meet the above needs. Ball protectors Figures 1 and 2 illustrate side views and top and bottom views of a ball protector 100 according to some embodiments. Figures 3 and 4 illustrate detailed side and top or bottom views of a distal end portion of the ball protector 100 according to some embodiments. Figure 5 illustrates a longitudinal cross-section of the distal end portion of the ball protector 100; Figure 6 illustrates a cross-section of the distal end portion of the ball protector where a tip piece 104 overlaps a distal end portion of a body piece 102; and Figure 7 illustrates a cross-section of a distal portion of the tip piece 104 of the ball protector 100 according to some embodiments. The Balloon Protector 100 is configured to cover and protect a drug-coated balloon of a balloon catheter (e.g., the Balloon Catheter 800 in Figure 8) during shipping or preoperative handling, which is necessary to maintain the integrity of the balloon catheter for the surgical procedures for which it is designed. As shown, the ball protector 100 includes the body piece 102 and the tip piece 104 attached to a distal end portion of the body piece 102. Each part of the body piece 102 and the tip piece 104 is unitary because it is a continuous piece. A section covering the ball 106 of the ball protector 100 includes the tip piece 104 and a distal portion of the body piece 102. The section covering the ball 106 also includes a transition section 108 of the body piece 102 opposite the tip piece 104. A tabbed section 110 of the ball protector 100 includes a proximal portion of the body piece 102. The section covering the balloon 106 is configured to cover a balloon of a balloon catheter, the balloon of which is normally arranged around a distal end portion. Rcafinn / zznz / e / YiAi of a balloon catheter shaft. The balloon cover section 106 is configured to cover the balloon of such a balloon catheter with at least one clearance fit (e.g., sliding fit, locating fit, etc.) up to a transition fit (e.g., tight fit), thereby holding the balloon in a folded and deflated configuration without compressing it to the slightest degree. With respect to the clearance fit, the balloon cover section 106 of the balloon protector 100 has an inside diameter slightly larger than the outside diameter of the balloon in the folded and deflated configuration. With respect to the transition fit, the inside diameter of the balloon cover section 106 is negligibly larger than the outside diameter of the balloon in the folded and deflated configuration. (Refer to International Organization for Standardization [ISO] 2768 for such tolerances). The tip piece 104 of the balloon protector 100 is configured to cover a distal flange of a balloon catheter balloon, a flange that typically does not include a drug coating. The tip piece 104 is attached (e.g., bonded, solvent-bonded, heat-welded, etc.) to a distal end portion of the body piece 102 of the balloon protector 100 such that the tip piece 104 has an overlapping portion 112 over the distal end portion of the body piece 102. The overlapping portion 112 has a larger outside diameter than a portion immediately proximal to the balloon-covering section 106 of the balloon protector 100. The outside diameter of the overlapping portion 112 of the tip piece 104 is configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector 100 is covering the balloon.The stopper has the advantage that it is preferable to leave a balloon protector on the balloon of a balloon catheter until the moment the balloon catheter is inserted into the introducer sheath, protecting the balloon from fluids (e.g., saline solution, body fluids, etc.), wet instruments, wet hands, or similar hazards. The stopper allows a clinician to leave the balloon protector on the balloon catheter balloon for as long as desired without the risk of inadvertently inserting the balloon catheter into the introducer sheath while the balloon protector is covering the balloon. Tip piece 104 has a tapered portion 114 that narrows from the overlapping portion 112 of tip piece 104 to a distal tip 116 of tip piece 104. The tapered portion 114 of tip piece 104 has an inside diameter taper proportional to the outside diameter of a distal flange of a balloon catheter. The inside diameter taper of the tapered portion 114 is configured to maintain concentricity between an opening 118 in the distal tip 116 and an opening at a distal end of a balloon catheter shaft for passing a guidewire through it. The tapered portion 114 also has an outside diameter taper. Depending on the outside diameter of the overlapping portion 112 of the tip piece 104, the length of the tip piece 104, or similar, the taper of the outside diameter may be greater than, equal to, or less than the taper of the inside diameter.The taper of the outer diameter is greater than the taper of the inner diameter in the. Rcafinn / zznz / e / YiAi modality of the ball protector 100 shown in figure 5. As explained below, the tip piece 104 and the conical portion 114 thereof facilitate the removal of the stylus. The tip piece 104 includes a longitudinal gap 120 on each side of two opposite sides of the ball protector 100. The longitudinal gap 120 of the tip piece 104 has a length equal to or greater than the overlapping portion 112 of the tip piece 104, measured from a proximal end of the tip piece 104. The length of the longitudinal gap 120 allows the distal end portion of the body piece 102 of the ball protector 100 to split through a distal end thereof without the increased peel force that would otherwise be required to split both the overlapping portion 112 of the tip piece 104 and the distal end portion of the body piece 102 beneath it. The length of the longitudinal gap 120 in the embodiment of the ball protector 100 shown in at least Figures 1, 3, and 5 is greater than that of the overlapping portion 112.In such embodiments, a window or through-hole 121 is formed between a distal end of the longitudinal space 120 and the distal end of the body piece 102. The through-hole 121 advantageously provides a momentary interruption in the applied peel force (e.g., ~1.5 lbf to 0 lbf) when the ball protector 100 splits in a distal direction along the section covering the ball 106 thereof. The splitting indicates that the distal end of the body piece 102 has split, which, in turn, indicates that the splitting is nearly complete with the beginning of the split through the tip piece 104. Transition section 108 of balloon protector 100 is configured to cover a proximal flange of a balloon catheter balloon, a flange that typically does not include a drug coating. Transition section 108 has a flare at least one outside diameter from a portion immediately distal to the balloon-covering section 106 of balloon protector 100 to a distal end of the tabbed section 110 of balloon protector 100. The flare of transition section 108 is configured to increase the distance between each tab of a pair of tabs 122 of the tabbed section 110 of balloon protector 100, making the tabs 122 easier to grip for splitting balloon protector 100. The flare of transition section 108 is also configured to facilitate the fabrication of catheter assemblies such as catheter assembly 900 shown below.In fact, the widening of the transition section 108 ensures that the drug coating 833 of the balloon 832 is not unnecessarily scraped when the balloon protector 100 is placed over the balloon 832. Furthermore, the transition section 108 minimizes any potential damage to the balloon 832 while it is in the deflated state. The tabbed section 110 of the ball protector 100 includes the pair of tabs 122, which are configured to provide a starting point from which to divide the ball-covering section 106 of the ball protector 100 along the weak line pairs 124 and 126 described below. In fact, the tabs 122 are configured to continuously engage and disengage from each other to progressively divide the ball protector. Rcafinn / zznz / e / YiAi 100 in a distal direction along the section covering the balloon 106 of the balloon protector 100 until the balloon protector 100 completely detaches from a balloon catheter balloon. Similar to the widening of the transition section 108 of the balloon protector 100, the tabbed section 110 has a widening configured to increase the distance between each tab of the tab pair 122 of the tabbed section 110, making the tabs 122 easier to grip for splitting the balloon protector 100. In addition, each tab of the tab pair 122 includes an inner and an outer surface. Any surface of the inner and outer surfaces of each tab, or both surfaces of each tab, can be textured, making the tabs 122 easier to grip for splitting the balloon protector 100.In the ball protector 100 modality shown in at least figures 1, 2 and 9, both the inner and outer surfaces of each tab of the tab pair 122 are textured. The body piece 102 along the section 106 covering the ball of the ball protector 100 includes a pair of opposing weak longitudinal lines 124 aligned with the tabs 122, along which the body piece 102 is configured to split. Likewise, the tip piece 104 of the section covering the ball 106 of the ball protector 100 includes a pair of opposing weak longitudinal lines 126 aligned with the tabs 122, along which the body piece 104 is configured to split. In particular, each weak line of the weak lines 124 of the body piece 102 extends into the longitudinal space 120 of the tip piece 104 through the distal end of the body piece 102. Each weak line of the weak lines 126 of the tip piece 104 extends from the distal end of the longitudinal space 120 of the tip piece 104 through a distal end of the distal tip 116 of the tip piece 104.If through-hole 121 were present on each side of the ball protector 100, the through-holes provide breaks between the weak lines 124 and the weak lines 126. The weak lines 124 and 126 may be notches or perforations along the section covering the ball 106, where the perforations include a series of longitudinal slits resembling a dashed line, a series of through-holes resembling a dotted line, or a combination thereof. Alternatively, the body piece 102 of the ball protector 100 lacks the pair of weak lines 124, the tip piece 104 of the ball protector 100 lacks the pair of weak lines 126, or both the body piece 102 and the tip piece 104 lack their respective pair of weak lines. Instead, the body piece 102, the tip piece 104, or each part of the body piece 102 and the tip piece 104, as the case may be, is formed from a polymeric material in which the main chains of the polymeric material are oriented along a length of the body piece 102 or the tip piece 104. The main chains of the polymeric material are configured to facilitate splitting from a starting point provided, for example, by the pair of tabs 122 when they are separated from each other, through a Rcafinn / zznz / e / YiAi remainder of body piece 102 or tip piece 104 without being torn transversely, body piece 102 or tip piece 104. Each body piece 102 and tip piece 104 of the ball protector 100 may be made of a polymeric material including, but not limited to, high-density polyethylene (HDPE) or expanded polytetrafluoroethylene (ePTFE). When the body piece 102 or tip piece 104 is made of ePTFE, the main chains of the ePTFE may be oriented along the body piece 102 or tip piece 104 to facilitate its splitting without the pair of weak lines 124 or 126 as stated above. When the body piece 102 or tip piece 104 is molded from the polymeric material, the body piece 102 or tip piece 104 is characteristic of the molding process used, such as injection molding, extrusion molding, compression molding, bladder molding, or similar processes. Catheter assemblies Figure 8 illustrates an 800 balloon catheter according to some modalities. Figure 9 illustrates a 900 catheter assembly that includes the 800 balloon catheter and the 100 balloon protector according to some modalities. Figure 10 illustrates a detailed side view of the 900 catheter assembly that includes a 928 stylet according to some modalities. The 900 catheter assembly includes an 800 balloon catheter, the 100 balloon protector, and optionally, the 928 stylet to maintain the integrity of the 900 catheter assembly during shipping or preoperative handling. The balloon catheter 800 includes a shaft 830, a balloon 832 in a deflated state disposed around a distal end portion of the shaft 830, and a bifurcated connector 834 around a proximal end portion of the shaft 830. The balloon 832 of the balloon catheter 800 may be a drug-coated balloon, wherein the drug coating 833 of balloon 832 is an antiproliferative or antirestenotic drug coating such as paclitaxel or rapamycin. Balloon 832 includes a proximal flange 836 and a distal flange 838, between which the drug coating 833 of balloon 832 is normally applied. That is, the proximal flange 836 and the distal flange 838 of balloon 832 do not normally include the drug coating 833. This is because the proximal and distal flanges 836 and 838 are not normally placed in apposition to an arterial lumen wall during atherosclerotic surgery. Notwithstanding the above, balloon 832 need not include the drug coating 833 in some modalities. The bifurcated connector 834 has an inflation port 840 fluidly connected to the balloon 832 of the balloon catheter 800 by means of an inflation lumen of the shaft 830 of the balloon catheter 800. The bifurcated connector 834 also has a guidewire port 842 connected to a guidewire lumen 844 that extends the entire length of the shaft 830 to an opening at a distal end of a shaft 830. Figures 9 and 10 show the stylet 928 within at least a distal end portion of the guidewire lumen 844 of the shaft 830. Rcafinn / zznz / e / YiAi The Balloon Protector 100 is described as set out above, which includes details regarding the configuration of the Balloon Protector 100 over a balloon of a balloon catheter such as the Balloon Catheter 800, as well as details on how the Balloon Protector 100 is configured to be removed from such a balloon catheter. The stylet 928, when present in the catheter assembly 900, is positioned within the tip piece 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 shipping or preoperative handling, for example, to prevent collapse of the guidewire lumen 844 of the shaft 830. The stylet 928 may be metallic (e.g., stainless steel) with a coiled distal end portion extending from the opening in the distal tip 116 of the tip piece 104 of the balloon protector 100, configured to prevent the stylet 928 from irretrievably slipping into the guidewire lumen 844 of the shaft 830. The coiled distal end portion of the stylet 928 is also configured to provide a handle for grasping and withdrawing the stylet. 928 of the catheter assembly 900 before using the catheter assembly 900. As shown by contrast between Figures 10 and 11, the pointed tip 104 of the balloon protector 100 and its tapered portion 114 advantageously facilitate grasping and removing the stylet 928 from the catheter assembly 900, which can be difficult with catheter assemblies such as the one in Figure 11. For example, the catheter assembly in Figure 11 has a balloon protector with a flared distal end portion, not a tapered distal end portion like that of the balloon protector 100. The coiled distal end portion of the stylet 928 can become coiled and hidden within the flared distal end portion of the balloon protector of the catheter assembly in Figure 11, making it difficult to grasp and remove the stylet 928 from the catheter assembly. However, due to the configuration of tip piece 104, the coiled distal end portion of stylet 928 remains exposed, making it easier to grasp and remove stylet 928 from catheter assembly 900. The 900 catheter assembly can be packaged sterile and ready for immediate use. Methods The methods for the 900 catheter assembly include a method for using the 900 catheter assembly. For example, the method of using the 900 catheter assembly includes an extraction step consisting of removing the 900 catheter assembly from a package containing the 900 catheter assembly. For the purposes of this example method, the 900 catheter assembly includes the balloon catheter 800, the balloon shield 100, and the stylet 928. The balloon catheter 800 includes the shaft 830, which has the lumen of the guidewire 844, and the balloon 832 in a deflated state arranged around the distal end portion of the shaft 830. The balloon 832 includes the drug coating 833. The balloon shield 100 includes the balloon cover section 106, which covers the balloon 832. The balloon cover section 106 includes a tip piece 104 of the balloon shield 100 coupled to a distal end portion of a body piece 102 of the balloon shield. RPQfinn / zznz / e / YiAi 100. Stylet 928 is positioned in the lumen of the guidewire 844 of the shaft 830 of the balloon catheter 800 to maintain the integrity of the catheter assembly 900 during shipping or preoperative handling. Stylet 928 has a coiled distal end portion extending from the opening in the distal tip 116 of the tip piece 104 of the balloon protector 100. The method includes an extraction step consisting of removing stylet 928 from catheter assembly 900 after the extraction step. The extraction step involves removing stylet 928 from catheter assembly 900 by the coiled distal end portion of stylet 928. The method includes a step of threading a proximal end portion of a guide wire through the opening at the distal end 116 of the tip piece 104 of the balloon protector 100 and into the lumen of the guide wire 844 of the balloon catheter 800. The distal end portion of the guide wire is then positioned in a patient's blood vessel around a narrowed or obstructed portion of the blood vessel that requires balloon angioplasty. Although not explicitly shown, the contrast between Figures 10 and 11 alludes to how the pointed tip 104 of the balloon protector 100 and its tapered portion 114 advantageously facilitate the threading step, which can be difficult with catheter assemblies like the one in Figure 11. As discussed earlier, the catheter assembly in Figure 11 has a balloon protector with a flared distal end portion, not a tapered distal end portion like that of the balloon protector 100. The flared distal end portion of the balloon protector can obscure a distal end portion of a balloon catheter shaft and an opening in a guidewire lumen, making threading difficult with many probing attempts. In fact, clinicians often remove such a balloon protector before threading is desired, which risks exposing the balloon of the balloon catheter to fluids (e.g.,saline solution, body fluids, etc.), wet instruments, wet hands, or the like. However, due to the configuration of tip piece 104, the opening 118 in the distal tip 116 of tip piece 104 remains exposed, facilitating threading (i.e., threading the proximal end portion of the guidewire through the opening 118 in the distal tip 116 of tip piece 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 tip piece 104 has the taper of the inner diameter proportional to the outer diameter of the distal flange 838 of the balloon 832, which maintains concentricity between the opening 118 in the distal tip 116 of the tip piece 104 and the opening at the distal end of the shaft 830 of the balloon catheter 800, thus further facilitating the threading step. The method includes a catheter assembly advancement step consisting of advancing the catheter assembly 900 over the guidewire to an opening at the proximal end of an introducer sheath. As previously stated, the tip piece 104 of the balloon protector 100 has the overlapping portion 112 over the distal end portion of the body piece 102 of the balloon protector 100 with an outside diameter larger than that of a portion immediately proximal to the balloon-covering section 106 of the balloon protector 100. The portion RPQfinn / zznz / e / YiAi superimposed 112 is configured to stop the advancement of the catheter assembly 900 into the introducer sheath with the balloon protector 100 covering the balloon 832. The method includes a peel-off step of detaching the balloon protector 100 from the balloon catheter 800 by continuously pulling the pair of tabs 122 from the tabbed section 110 of the balloon protector 100 to progressively split the balloon protector 100. As previously stated, both the body piece 102 and the tip piece 104 of the balloon-covering section 106 of the balloon protector 100 include the pairs of weak lines 124 and 126 aligned with the tabs 122. The balloon-covering section 106 is configured to split along each weak line 124 and 126. The method may also include a balloon catheter advancement step to advance the balloon 832 of the balloon catheter 800 over the guide wire to the narrowed or blocked portion of the blood vessel that needs balloon angioplasty. The method may include an inflation step to inflate the balloon 832 to widen the narrowed or obstructed portion of the blood vessel. As previously stated, the balloon catheter 800 includes the bifurcated center 834 on a proximal end portion of the shaft 830 that includes the inflation port 840 fluidly connected to the balloon 832 by means of the inflation lumen of the shaft 830, the inflation port 840 of which is used for the inflation step. Although some specific modalities have been described in this document, and although these specific modalities have been described in some detail, it is not intended that they limit the scope of the concepts presented herein. Further adaptations and / or modifications may be necessary for those skilled in the art, and these adaptations and / or modifications are also covered in broader terms. Therefore, deviations from the specific modalities described herein are permissible without departing from the scope of the concepts presented herein.

Claims

1. A balloon protector, comprising: a balloon-covering section configured to cover a drug-coated balloon of a balloon catheter, the balloon-covering section including a balloon protector tip piece coupled to a distal end portion of a balloon protector body piece; and a tabbed section proximal to the balloon-covering section, the tabbed section including a pair of tabs configured to continuously separate from each other to progressively divide the balloon protector along the balloon-covering section until the balloon protector is completely peeled away from the balloon.

2. The balloon protector according to claim 1, wherein the tip piece has a tapered portion having a tapered inner diameter proportional to the outer diameter of a distal flange of the balloon, the tapered inner diameter of the tip piece being configured to maintain concentricity between an opening at a distal end of the tip piece and an opening at a distal end of a balloon catheter shaft for screwing a guide wire through it.

3. The balloon protector according to any of claim 1 or 2, wherein the tip piece has an overlapping portion over the distal end portion of the body piece having an outside diameter greater than that of an immediately proximal portion of the section covering the balloon, the outside diameter of the overlapping portion of the tip piece being configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector covers the balloon.

4. The ball protector according to claim 3, wherein the tip piece includes a longitudinal space on each side of two opposite sides of the ball protector, the longitudinal space having a length greater than or equal to that of the overlapping portion of the tip piece, allowing the distal end portion of the body piece to split through a distal end of the body piece without an increase in the applied peel force.

5. The ball protector according to claim 4, wherein the length of the longitudinal space is greater than that of the overlapping portion of the tip piece, thereby forming a through hole between a distal end of the longitudinal space and the distal end of the body piece.

6. The ball protector according to claim 5, wherein the through-hole is configured to provide an interruption in the peel force applied when splitting the ball protector along the section covering the ball, the interruption being indicated by the splitting through the distal end of the body piece. RPQRnn / zznz / e / YiAi 7. The ball protector according to any of claims 1-6, wherein both the body piece and the tip piece of the ball-covering section include a pair of opposing weak longitudinal lines aligned with the tabs, the ball-covering section being configured to split along each line of the weak lines.

8. The ball protector according to any claim of claims 1 to 7, the section covering the ball further includes a transition section configured to cover a proximal rim of the ball, the transition section having an outside diameter widening from a portion immediately distal to the section covering the ball to a distal end of the section with tabs configured to increase a distance between the tabs making the tabs easier to grip.

9. The ball protector according to any of claims 1 to 8, wherein each tab of the pair of tabs includes an inner surface and an outer surface, the inner and outer surfaces of each tab being textured to make the tabs easier to grip.

10. A catheter assembly comprising: a balloon catheter including: a shaft; and a drug-coated balloon in a deflated state disposed around a distal end portion of the shaft; and a balloon shield including: a balloon-covering section, the balloon-covering section including a balloon shield tip piece coupled to a distal end portion of a balloon shield body piece; and a tabbed section proximal to the balloon-covering section, the tabbed section including a pair of tabs configured to continuously separate from each other to progressively split the balloon shield along the balloon-covering section until the balloon shield is completely peeled away from the balloon.

11. The catheter assembly according to claim 10, wherein the tip piece has a tapered portion having a tapered inner diameter proportional to the outer diameter of a distal flange of the balloon, the tapered inner diameter of the tip piece being configured to maintain concentricity between an opening at a distal end of the tip piece and an opening at a distal end of the balloon catheter for screwing a guide wire through it.

12. The catheter assembly according to claim 11, further comprising a stylet disposed in a guidewire lumen of the balloon catheter shaft to maintain the integrity of the catheter assembly during transport or preoperative handling, the stylet having a coiled distal end portion extending from the Rcafinn / zznz / e / YiAi opening at the distal end of the balloon protector tip piece configured to grip for removing the stylet from the catheter assembly.

13. The catheter assembly according to any of claims 10 to 12, wherein the tip piece has an overlapping portion over the distal end portion of the body piece having an outside diameter greater than that of an immediately proximal portion of the balloon-covering section, the outside diameter of the overlapping portion of the tip piece being configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon shield covers the balloon.

14. The catheter assembly according to claim 13, wherein the tip piece includes a longitudinal space on each side of two opposite sides of the balloon shield, the longitudinal space having a length greater than or equal to that of the overlapping portion of the tip piece, allowing the distal end portion of the body piece to split through a distal end of the body piece without an increase in the applied peel force.

15. The catheter assembly according to claim 14, wherein the length of the longitudinal space is greater than that of the overlapping portion of the tip piece, thereby forming a through hole between a distal end of the longitudinal space and the distal end of the body piece.

16. The catheter assembly according to claim 15, wherein the through-hole is configured to provide an interruption in the peeling force applied when splitting the balloon shield along the section covering the balloon, the interruption indicating the splitting through the distal end of the body piece.

17. The catheter assembly according to any of claims 10 to 16, wherein both the body piece and the tip piece of the balloon-covering section include a pair of opposing weak longitudinal lines aligned with the tabs, the balloon-covering section being configured to split along each line of the weak lines.

18. The catheter assembly according to any claim of claims 10 to 17, the section covering the balloon further includes a transition section configured to cover a proximal flange of the balloon, the transition section having an outside diameter widening from a portion immediately distal to the section covering the balloon to a distal end of the tabbed section configured to increase a distance between the tabs making the tabs easier to grip.

19. The catheter assembly according to any of claims 10 to 18, wherein each tab of the tab pair includes an inner and an outer surface, the inner and outer surfaces of each tab being textured which includes making the tabs easier to grip.

20. The catheter assembly according to any of claims 10 to 19, wherein the balloon catheter further includes a bifurcated connector around a proximal end portion of the shaft, the bifurcated connector having an inflation port fluidly connected to the balloon by means of an inflation lumen of the shaft.

21. A method of a catheter assembly comprising: removing the catheter assembly from a catheter assembly package, the catheter assembly including: a balloon catheter including: a shaft having a guidewire lumen; and a drug-coated balloon in a deflated state disposed around a distal end portion of the shaft; and a balloon shield including: a section covering the balloon, the section covering the balloon including a balloon shield tip piece coupled to a distal end portion of a balloon shield body piece; and a stylet disposed in the guidewire lumen of the balloon catheter shaft, the stylet having a coiled distal end portion extending from an opening at a distal end of the balloon shield tip piece; removing the stylet from the catheter assembly by the coiled distal end portion;and thread a proximal end portion of a guide wire through the opening at the distal end of the balloon protector tip piece and into the lumen of the balloon catheter guide wire.

22. The method according to claim 21, wherein the tip piece of the balloon protector has a tapered portion having a tapered inner diameter proportional to the outer diameter of a distal flange of the balloon, the tapered inner diameter of the tip piece being configured to maintain concentricity between the opening at the distal end of the tip piece and an opening at a distal end of the balloon catheter shaft, thereby facilitating the threading of the guidewire into the lumen of the balloon catheter guidewire.

23. The method according to any of claims 21 or 22, wherein a distal end portion of the guide wire is disposed in a patient's blood vessel around a narrowed or obstructed portion of the blood vessel that requires balloon angioplasty.

24. The method according to claim 23, further characterized in that it also comprises: advancing the balloon catheter over the guidewire to the narrowed or obstructed portion of the blood vessel requiring balloon angioplasty; and inflating the balloon to widen the narrowed or obstructed portion of the blood vessel, the balloon catheter including a bifurcated connector on a proximal end portion of the Rcafinn / zznz / e / YiAi shaft including an inflation port fluidly connected to the balloon by means of an inflation lumen of the shaft.

25. The method according to any of claims 21 to 24, further comprising advancing the catheter assembly over the guidewire to an opening 5 in a proximal end of an introducer sheath, the tip piece of the balloon protector having a portion overlapping the distal end portion of the body piece with an outside diameter greater than that of a portion immediately proximal to the section covering the balloon configured to stop the advancement of the catheter assembly into the introducer sheath with the balloon protector covering the balloon. 10 26.The method according to any claim of claims 21 to 25, further comprising detaching the balloon protector from the balloon catheter by continuously pulling on a pair of tabs to progressively separate the balloon protector, the balloon protector including a tabbed section adjacent to the balloon-covering section that includes the pair of tabs. 15 27. The method according to claim 26, wherein both the body piece and the tip piece of the balloon-covering section of the balloon protector include a pair of opposing weak longitudinal lines aligned with the tabs, the balloon-covering section being configured to split along each line of the weak lines.

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