Balloon protector and balloon catheter assembly

Abstract

Disclosed herein are a balloon protector, a balloon catheter including the balloon protector, and a method thereof. The balloon protector includes a balloon-coated section and a tabbed section proximal to the balloon-coated section. The balloon-coated section is configured to cover a drug-coated balloon of the balloon catheter. The balloon-coated section includes a balloon protector tip component coupled to a distal portion of the balloon protector body component. The tabbed section includes a pair of tabs configured to be continuously pulled apart from each other to gradually separate the balloon protector along the balloon-coated section until the balloon protector is completely peeled off from the balloon. Advantageously, the outer diameter of the tip component can provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon of the balloon protector.

Description

Technical Field

[0001] The present invention relates to a balloon protector and a balloon catheter assembly.

Background Art

[0002] Atherosclerosis is characterized by one or more intravascular lesions partly formed by plaques containing substances such as fat, cholesterol, and calcium in the blood. Intravascular lesions such as arterial lesions are formed on the wall of the arterial lumen and may accumulate across the lumen to the opposite wall. The final patent lumen often occurs at the boundary between the arterial lesion and the opposite wall of the arterial lumen. Surgical procedures for atherosclerosis, such as balloon angioplasty using a drug-coated balloon, can be used to restore the patent lumen and blood flow lost due to one or more intravascular lesions.

[0003] A balloon protector is designed to cover and protect the drug-coated balloon of a balloon catheter during transportation or pre-operative handling, which is necessary to maintain the integrity of the balloon catheter for the surgical procedure for which the balloon catheter is designed. Further, the balloon protector prevents clinicians and others from inadvertently contacting the antiproliferative drug of the drug-coated balloon when handling the balloon catheter before the surgical procedure. The aforementioned needs for balloon protectors continue to exist, but there are further needs such as the need to protect the balloon catheter from advancing into the introducer sheath without first removing the balloon protector.

[0004] Disclosed herein are balloon protectors, balloon catheters including balloon protectors, and methods thereof that meet or exceed the aforementioned needs.

Summary of the Invention

Means for Solving the Problems

[0005] Disclosed herein is a balloon protector for a balloon catheter. The balloon protector includes a balloon covering section and a tabbed section on the proximal side of the balloon covering section. The balloon covering section is configured to cover the drug-coated balloon of the balloon catheter. The balloon covering section includes a tip component of the balloon protector coupled to the tip portion of the main body component of the balloon protector. The tabbed section includes a pair of tabs configured to be continuously pulled apart from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely peeled off from the balloon.

[0006] In some embodiments, the tip component has a tapered portion having an inner diameter taper configured to correspond to the outer diameter of the distal side shoulder of the balloon. The inner diameter taper of the tip component is configured to maintain concentricity between the opening at the tip of the tip component and the opening at the tip of the shaft of the balloon catheter for passing a guide wire.

[0007] In some embodiments, the tip component has an overlap portion on the tip portion of the main body component. In other words, the overlap portion partially overlaps the tip portion of the main body component. The overlap portion has an outer diameter larger than the outer diameter of the immediately proximal side portion of the balloon covering section. The outer diameter of the overlap portion of the tip component is configured to provide a stop to prevent insertion of the balloon catheter into the introducer sheath while the balloon protector covers the balloon.

[0008] In some embodiments, the tip component includes longitudinal gaps on each of two opposing sides of the balloon protector. The longitudinal gaps have a length greater than or equal to the length of the overlap portion of the tip component. The balloon protector is configured such that, due to the length of the longitudinal gaps, the tip portion of the main body component can be separated across the tip of the main body component without an accompanying increase in the applied peeling force.

[0009] In some embodiments, the length of the longitudinal gap exceeds the length of the overlapping portion of the chip component. Due to the length of the longitudinal gap, the balloon protector is configured such that a through hole is formed between the tip of the longitudinal gap and the tip of the body component.

[0010] In some embodiments, the balloon protector is configured such that when the balloon protector is separated along the balloon covering section, the through hole is configured to provide interruption of the applied peeling force, and the interruption indicates the separation through the tip of the body component.

[0011] In some embodiments, both the body component and the chip component of the balloon covering section include a pair of opposing longitudinal weak lines aligned with tabs. The balloon protector is configured such that the balloon covering section is separated along each of the weak lines.

[0012] In some embodiments, the balloon covering section further includes a transition section configured to cover the proximal shoulder of the balloon. The transition section has an outer diameter flare from the (immediate) distal side portion of the balloon covering section to the tip of the tabbed section. The outer diameter flare is configured to increase the distance between the tabs. This is an option to make it easier to grip the tabs.

[0013] In some embodiments, each tab of the pair of tabs includes an inner surface and an outer surface. The inner and outer surfaces of each tab are optionally textured. This is an option to make it easier to grip the tabs.

[0014] Also disclosed herein is a catheter assembly. The catheter assembly, in some embodiments, includes a balloon catheter and a balloon protector. The balloon catheter includes a shaft and an unexpanded medicated coating balloon disposed around a distal portion of the shaft. The balloon protector can be the balloon protector described in any of paragraphs 0004 - 0012 above. For example, the balloon protector can include a balloon covering section and a tabbed section proximal to the balloon covering section. The balloon covering section covers the balloon of the balloon catheter. The balloon covering section includes a tip component of the balloon protector coupled to a distal portion of the body component of the balloon protector. The tabbed section includes a pair of tabs configured to be continuously pulled apart from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon.

[0015] In some embodiments, the tip component has a tapered portion having an inner diameter taper corresponding to the outer diameter of the distal shoulder of the balloon. The inner diameter taper of the tip component is configured to maintain concentricity between the opening at the distal end of the tip component and the opening at the distal end of the shaft of the balloon catheter for passing a guide wire.

[0016] In some embodiments, the catheter assembly further includes a stylet disposed within the guide wire lumen of the shaft of the balloon catheter such that the catheter assembly is configured to maintain the integrity of the catheter assembly during transportation or pre - operative handling. The stylet has a coiled distal portion extending from an opening at the distal end of the tip component of the balloon protector and is configured to be gripped for pulling the stylet out of the catheter assembly.

[0017] In some embodiments, the chip component has an overlap portion on the tip portion of the body component. The overlap portion has an outer diameter larger than the outer diameter of the immediate proximal side portion of the balloon covering section. The outer diameter of the overlap portion of the chip component is configured to provide a stop to prevent insertion of the balloon catheter into the introducer sheath while the balloon protector covers the balloon.

[0018] In some embodiments, the chip component includes longitudinal gaps in each of two opposing side portions of the balloon protector. The longitudinal gaps have a length greater than or equal to the length of the overlap portion of the chip component. The length of the longitudinal gaps enables separation of the tip portion of the body component along the tip of the body component without an accompanying increase in the applied peeling force.

[0019] In some embodiments, the length of the longitudinal gaps exceeds the length of the overlap portion of the chip component. The length of the longitudinal gaps forms a through hole between the tip of the longitudinal gap and the tip of the body component.

[0020] In some embodiments, the through hole is configured to provide interruption of the applied peeling force when separating the balloon protector along the balloon covering section, and the interruption indicates separation through the tip of the body component.

[0021] In some embodiments, both the body component and the chip component of the balloon covering section include a pair of opposing longitudinal weak lines aligned with tabs. The balloon covering section is configured to separate along each of the weak lines.

[0022] In some embodiments, the balloon covering section further includes a transition section configured to cover the proximal side shoulder of the balloon. The transition section has an outer diameter flare from the immediate distal side portion of the balloon covering section to the tip of the tabbed section. The outer diameter flare is configured to increase the distance between the tabs and facilitate gripping of the tabs.

[0023] In some embodiments, each tab of a pair of tabs includes an inner surface and an outer surface. The inner and outer surfaces of each tab are optionally textured to make it easier to grip the tab. In some embodiments, the balloon catheter further includes a bifurcated hub around a proximal end portion of the shaft. The bifurcated hub has an inflation port fluidly connected to the balloon via an extended lumen of the shaft.

[0024] Also disclosed herein is a method of a catheter assembly including a removal step of removing the catheter assembly from a catheter assembly package in some embodiments. The catheter assembly can be the catheter assembly described in any of the preceding paragraphs 0013 - 0023. For example, the catheter assembly includes a balloon catheter, a balloon protector, and a stylet. The balloon catheter includes a shaft having a guide wire lumen and an unexpanded drug-coated balloon disposed around a distal end portion of the shaft. The balloon protector can be the balloon protector described in any of the preceding paragraphs 0004 - 0012. For example, the balloon protector includes a balloon covering section covering the balloon. The balloon covering section includes a tip component of the balloon protector coupled to a distal end portion of a body component of the balloon protector. The stylet is disposed within the guide wire lumen of the shaft of the balloon catheter. The stylet has a coiled distal end portion extending from an opening at a distal end of the tip component of the balloon protector. The method also includes a withdrawal step of withdrawing the stylet from the catheter assembly by the coiled distal end portion. The method also includes a threading step of threading a proximal end portion of a guide wire through an opening at a distal end of the tip component of the balloon protector into the guide wire lumen of the balloon catheter.

[0025] In some embodiments, the tip component of the balloon protector has a tapered portion having an inner diameter taper corresponding to the outer diameter of the distal shoulder of the balloon. The inner diameter taper of the tip component is configured to maintain concentricity between the opening at the tip of the tip component and the opening at the tip of the shaft of the balloon catheter. Maintaining concentricity facilitates passing a guide wire through the guide wire lumen of the balloon catheter.

[0026] In some embodiments, the distal portion of the guide wire is positioned around the stenosis or occlusion of the blood vessel in the patient's blood vessel that requires balloon angioplasty. In some embodiments, the method further includes a balloon catheter advancement step of advancing the balloon catheter on the guide wire to the stenosis or occlusion of the blood vessel that requires balloon angioplasty. The method also includes an expansion step of expanding the balloon to widen the stenosis or occlusion of the blood vessel. The balloon catheter includes a branch hub on the proximal end portion of the shaft that includes an expansion port fluidly connected to the balloon via an expansion lumen of the shaft.

[0027] In some embodiments, the method further includes a catheter assembly advancement step of advancing the catheter assembly on the guide wire to the opening at the proximal end of the introducer sheath. The tip component of the balloon protector has an overlap portion on the distal portion of the body component that has an outer diameter larger than the outer diameter of the immediately proximal side portion of the balloon covering section. The overlap portion is configured to stop the advancement of the catheter assembly into the introducer sheath with the balloon protector covering the balloon.

[0028] In some embodiments, the method further includes a peeling step of peeling the balloon protector from the balloon catheter by continuously pulling a pair of tabs away from each other to gradually separate the balloon protector. The balloon protector includes a tabbed section on the proximal side of the balloon covering section that includes a pair of tabs.

[0029] In some embodiments, both the body component and the tip component of the balloon covering section of the balloon protector include a pair of opposing longitudinal weak lines aligned with tabs. The balloon covering section is configured to separate along each of the weak lines.

[0030] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which disclose specific embodiments of such concepts in greater detail.

Brief Description of the Drawings

[0031]

Figure 1

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Figure 11

[0032] Before more particularly disclosing some specific embodiments, 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 can have features that can be readily separated from the specific embodiments and optionally combined with or replaced by any of several other embodiments disclosed herein.

[0033] Regarding the terms used herein, it should also be understood that the terms are for the purpose of describing some specific embodiments and 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 continuity or numerical limitation. For example, the "first", "second", and "third" features or steps do not have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to those three features or steps. Designations such as "left", "right", "front", "rear", "top", "bottom", "proximal side", "distal side", and similar phrases are used for convenience and are not intended to mean, for example, a particular defined position, orientation, direction, etc. Rather, such designations are used, for example, to reflect relative positions, orientations, directions, etc. The singular forms of "a", "an", and "the" include references to the plural unless the context clearly indicates otherwise.

[0034] For example, with respect to the "proximal end side", "proximal end side portion", or "proximal end portion" of the catheter disclosed in this specification, it includes the portion of the catheter intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal end side length" of the catheter includes the length of the catheter intended to be located near the clinician when the catheter is used on a patient. For example, the "proximal end" of the catheter includes the end of the catheter intended to be located near the clinician when the catheter is used on a patient. The proximal end side portion, proximal end portion, or proximal end side length of the catheter may include the proximal end of the catheter. However, the proximal end side portion, proximal end portion, or proximal end side length of the catheter does not necessarily include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal end side portion, proximal end portion, or proximal end side length of the catheter is not the distal end portion or the length of the distal end of the catheter.

[0035] For example, with respect to the "distal end side", "distal end side portion", or "distal end portion" of the catheter disclosed in this specification, it includes the portion of the catheter intended to be located near or inside the patient when the catheter is used on a patient. Similarly, for example, the "distal end side length" of the catheter includes the length of the catheter intended to be located near or inside the patient when the catheter is used on a patient. For example, the "distal end" of the catheter includes the end of the catheter intended to be located near or inside the patient when the catheter is used on a patient. The distal end side portion, distal end portion, or distal end side length of the catheter may include the distal end of the catheter. However, the distal end side portion, distal end portion, or distal end side length of the catheter does not necessarily include the distal end of the catheter. That is, unless the context suggests otherwise, the distal end side portion, distal end portion, or distal end side length of the catheter is not the distal end portion or the length of the distal end of the catheter.

[0036] Unless otherwise defined, all technical and scientific terms used herein shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0037] Again, the balloon protector is designed to cover and protect the drug-coated balloon of a balloon catheter during transportation or pre-operative handling, which is necessary to maintain the integrity of the balloon catheter for the surgical procedure for which the balloon catheter is designed. Further, the balloon protector prevents clinicians and others from inadvertently contacting the growth inhibitor of the drug-coated balloon when handling the balloon catheter prior to the surgical procedure. The aforementioned needs for the balloon protector continue to exist, but there are additional needs such as the need to protect the balloon catheter from advancing into the introducer sheath without first removing the balloon protector.

[0038] Disclosed herein are balloon protectors, balloon catheters including the balloon protectors, and methods thereof that meet or exceed the aforementioned needs. Balloon Protector Figures 1 and 2 show side views and top or bottom views of a balloon protector 100 according to some embodiments. Figures 3 and 4 show detailed side views and top or bottom views of the tip portion of a balloon protector 100 according to some embodiments. Figure 5 shows a longitudinal cross-sectional view of the tip portion of the balloon protector 100. Figure 6 shows a cross-sectional view of the tip portion of the balloon protector where the chip component 104 overlaps the tip portion of the body component 102. Figure 7 shows a cross-sectional view of the tip portion of the chip component 104 of the balloon protector 100 according to some embodiments.

[0039] The balloon protector 100 is configured to cover and protect the drug-coated balloon of a balloon catheter (e.g., the balloon catheter 800 of Figure 8) during transportation or pre-operative handling. This is necessary to maintain the integrity of the balloon catheter for the surgical procedure for which the balloon catheter is designed.

[0040] As shown, the balloon protector 100 includes a body component 102 and a tip component 104 coupled to the tip portion of the body component 102. Each of the body component 102 and the tip component 104 is integral in that it is one continuous piece. The balloon covering section 106 of the balloon protector 100 includes the tip component 104 and the tip side portion of the body component 102. The balloon covering section 106 also includes a transition section 108 of the body component 102 on the opposite side of the tip component 104. The tabbed section 110 of the balloon protector 100 includes the proximal side portion of the body component 102.

[0041] The balloon covering section 106 is configured to cover the balloon of a balloon catheter. The balloon is typically disposed around the tip portion of the shaft of the balloon catheter. The balloon covering section 106 is configured to cover the balloon of such a balloon catheter by at least a clearance fit (e.g., a slip fit, a location fit, etc.) to an interference fit (e.g., a press fit), thereby holding the balloon in a non-expanded, folded configuration without compressing the balloon until it is minimally compressed. With respect to the clearance fit, the balloon covering section 106 of the balloon protector 100 has an inner diameter that is at least slightly larger than the outer diameter of the balloon in a non-expanded, folded configuration. With respect to the interference fit, the inner diameter of the balloon covering section 106 is slightly larger than the outer diameter of the balloon in a non-expanded, folded configuration (see ISO 2768 for such tolerances).

[0042] The chip component 104 of the balloon protector 100 is configured to cover the tip-side shoulder portion of the balloon of the balloon catheter, and this shoulder portion typically does not include a drug coating. The chip component 104 is coupled (e.g., adhered, solvent-bonded, heat-welded, etc.) to the tip portion of the main body component 102 of the balloon protector 100 such that the chip component 104 has an overlap portion 112 over the tip portion of the main body component 102. The overlap portion 112 has an outer diameter that is larger than the outer diameter of the immediate proximal-side portion of the balloon covering section 106 of the balloon protector 100. The outer diameter of the overlap portion 112 of the chip component 104 is configured to provide a stop to prevent insertion of the balloon catheter into the introducer sheath while the balloon protector 100 covers the balloon. The stop is advantageous in that it prioritizes leaving the balloon protector on the balloon of the balloon catheter until the moment the balloon catheter is inserted into the introducer sheath to protect the balloon from fluid (e.g., saline, body fluid, etc.), wet instruments, wet hands, etc. The stop enables the clinician to leave the balloon protector on the balloon of the balloon catheter as desired without the risk of inadvertently inserting the balloon catheter into the introducer sheath while the balloon protector 100 covers the balloon.

[0043] The chip component 104 has a tapered portion 114 that tapers from the overlapping portion 112 of the chip component 104 to the tip-side chip 116 of the chip component 104. The tapered portion 114 of the chip component 104 has an inner diameter taper corresponding to the outer diameter of the tip-side shoulder of the balloon of the balloon catheter. The inner diameter taper of the tapered portion 114 is configured to maintain concentricity between the opening 118 of the tip-side chip 116 and the opening of the tip portion of the shaft of the balloon catheter for passing a guide wire. The tapered portion 114 also has an outer diameter taper. Depending on the outer diameter of the overlapping portion 112 of the chip component 104, the length of the chip component 104, etc., the outer diameter taper can be larger than, equal to, or smaller than the inner diameter taper. In the embodiment of the balloon protector 100 shown in FIG. 5, the outer diameter taper is larger than the inner diameter taper. As described below in this specification, the chip component 104 and its tapered portion 114 facilitate the removal of the stylet.

[0044] The chip component 104 includes longitudinal gaps 120 in each of two opposing side portions of the balloon protector 100. The longitudinal gaps 120 of the chip component 104 have a length greater than or equal to the length of the overlapping portion 112 of the chip component 104 when measured from the proximal end portion of the chip component 104. Due to the length of the longitudinal gaps 120, the distal end portion of the body component 102 of the balloon protector 100 can be separated along its distal end without an accompanying increase in the applied peeling force that would have been necessary to separate both the overlapping portion 112 of the chip component 104 and the distal end portion of the underlying body component 102. The length of the longitudinal gaps 120 in the embodiments of the balloon protector 100 shown in at least FIGS. 1, 3, and 5 exceeds the length of the overlapping portion 112. In such embodiments, a window or through-hole 121 is formed between the distal end of the longitudinal gap 120 and the distal end of the body component 102. The through-hole 121 advantageously provides an instantaneous interruption of the applied peeling force (e.g., from about 6.7 N (1.5 lbf) to 0 N (0 lbf)) when the balloon protector 100 is separated in the distal direction along its balloon covering section 106. The interruption indicates that the distal end portion of the body component 102 has been separated and further indicates that the completion of the separation is near due to the start of the separation of the chip component 104.

[0045] The transition section 108 of the balloon protector 100 is configured to cover the proximal shoulder of the balloon of the balloon catheter. The shoulder typically does not include a drug coating. The transition section 108 has a flare at least in its outer diameter from the tip-side portion immediately adjacent to the balloon covering section 106 of the balloon protector 100 to the tip of the tabbed section 110 of the balloon protector 100. The flare of the transition section 108 is configured to increase the distance between each pair of tabs 122 of the tabbed section 110 of the balloon protector 100, thereby making it easier to grip the tabs 122 for separating the balloon protector 100. The flare of the transition section 108 is also configured to facilitate the manufacture of a catheter assembly, such as the catheter assembly 900 described below. In fact, the flare 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 placed on the balloon 832. Further, the transition section 108 minimizes the possibility of the balloon 832 being damaged when not in an expanded state.

[0046] The tabbed section 110 of the balloon protector 100 includes a pair of tabs 122 that are configured to provide a starting point for separating the balloon covering section 106 of the balloon protector 100 along a pair of frangible lines 124 and 126 described below. In fact, the tabs 122 are configured to be grasped and continuously pulled apart from each other to gradually separate the balloon protector 100 in the 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. Like the flare of the transition section 108 of the balloon protector 100, the tabbed section 110 has a flare that makes it easier to grasp the tabs 122 for separating the balloon protector 100 by being configured to increase the distance between each of the pair of tabs 122 of the tabbed section 110. Further, each tab of the pair of tabs 122 includes an inner surface and an outer surface. Either or both of the inner and outer surfaces of each tab may be textured to make it easier to grasp the tabs 122 for separating the balloon protector 100. In at least the embodiments of the balloon protector 100 shown in FIGS. 1, 2, and 9, both the inner and outer surfaces of each tab of the pair of tabs 122 are textured.

[0047] The body component 102 includes a pair of opposing longitudinal weak lines 124 aligned with the tabs 122 along the balloon covering section 106 of the balloon protector 100, and along the pair of opposing longitudinal weak lines 124, the body component 102 is configured to separate. Similarly, the chip component 104 of the balloon covering section 106 of the balloon protector 100 includes a pair of opposing longitudinal weak lines 126 aligned with the tabs 122, and along the pair of opposing longitudinal weak lines 126, the chip component 104 is configured to separate. In particular, each of the weak lines of the weak lines 124 of the body component 102 extends through the tip of the body component 102 into the longitudinal gap 120 of the chip component 104. Each of the weak lines of the weak lines 126 of the chip component 104 extends from the tip of the longitudinal gap 120 of the chip component 104 through the tip of the tip-side chip 116 of the chip component 104. When through-holes 121 are present on both sides of the balloon protector 100, the through-holes provide a break between the weak line 124 and the weak line 126. The weak line 124 and the weak line 126 can be cut lines or perforations along the balloon covering section 106, and the perforations include a series of longitudinal slits similar to dashed lines, a series of through-holes similar to dotted lines, or a combination thereof.

[0048] Alternatively, instead of the foregoing, the body component 102 of the balloon protector 100 does not have a pair of weak lines 124, the chip component 104 of the balloon protector 100 does not have a pair of weak lines 126, or neither of the body component 102 and the chip component 104 has their respective pair of weak lines. Instead, each of the body component 102, the chip component 104, or the body component 102 and the chip component 104 may, in some cases, be formed of a polymer material in which the main chain of the polymer material is oriented along the length of the body component 102 or the chip component 104. The main chain of the polymer material is configured to facilitate separation from a starting point provided, for example, by a pair of tabs 122 without transversely fracturing the body component 102 or the chip component 104 when pulled apart from each other across the remainder of the body component 102 or the chip component 104.

[0049] Each of the body part 102 and the tip part 104 of the balloon protector 100 can be made of a polymeric material including, but not limited to, high density polyethylene ("HDPE") or expanded polytetrafluoroethylene ("ePTFE"). If either the body part 102 or the tip part 104 is ePTFE, the main chain of the ePTFE can be oriented along the length of the body part 102 or the tip part 104 to facilitate its separation without the pair of weak lines 124 or weak line 126 as described above. When the body part 102 or the tip part 104 is molded from a polymeric material, the body part 102 or the tip part 104 exhibits the characteristics of the molding process used, such as injection molding, extrusion, compression molding, bladder molding, etc.

[0050] Catheter assembly FIG. 8 shows a balloon catheter 800 according to some embodiments. FIG. 9 shows a catheter assembly 900 including the balloon catheter 800 and the balloon protector 100 according to some embodiments. FIG. 10 shows a detailed side view of the catheter assembly 900 including a stylet 928 according to some embodiments.

[0051] The catheter assembly 900 includes a balloon catheter 800, a balloon protector 100, and optionally, a stylet 928 for maintaining the integrity of the catheter assembly 900 during transportation or pre-operative handling.

[0052] The balloon catheter 800 includes a shaft 830, a balloon 832 disposed around the distal end portion of the shaft 830 in an unexpanded state, and a branch hub 834 around the proximal end portion of the shaft 830.

[0053] The balloon 832 of the balloon catheter 800 can be a drug-coated balloon, and the drug coating 833 of the balloon 832 is a coating of a growth inhibitory drug or an anti-restenosis drug such as paclitaxel or rapamycin. The balloon 832 includes a proximal shoulder 836 and a distal shoulder 838, and the drug coating 833 of the balloon 832 is typically applied between the shoulder 836 and the shoulder 838. That is, the proximal shoulder 836 and the distal shoulder 838 of the balloon 832 typically do not include the drug coating 833. This is because the proximal shoulder 836 and the distal shoulder 838 are typically not juxtaposed against the wall of the arterial lumen during surgical intervention for atherosclerosis. Nevertheless, in some embodiments, the balloon 832 need not include the drug coating 833.

[0054] The branch hub 834 has an inflation port 840 fluidly connected to the balloon 832 of the balloon catheter 800 through an enlarged lumen of the shaft 830 of the balloon catheter 800. The branch hub 834 also has a guide wire port 842 connected to a guide wire lumen 844 that extends along the entire length of the shaft 830 to an opening at the tip of the shaft 830. FIGS. 9 and 10 show a stylet 928 within at least the tip portion of the guide wire lumen 844 of the shaft 830.

[0055] The balloon protector 100 is described as above, including details regarding the configuration of the balloon protector 100 on the balloon of a balloon catheter such as the balloon catheter 800, as well as details regarding how the balloon protector 100 is configured to be removed from such a balloon catheter.

[0056] When stylet 928 is present within catheter assembly 900, it is disposed within both the tip component 104 of balloon protector 100 and the guide wire lumen 844 of shaft 830 of balloon catheter 800 to maintain the integrity of catheter assembly 900 during transportation of catheter assembly 900 or during pre-operative handling, for example, to prevent collapse of the guide wire lumen 844 of shaft 830. Stylet 928 can be made of metal (e.g., stainless steel), and the coiled tip portion extends from the opening of tip 116 on the distal end side of tip component 104 of balloon protector 100 configured to prevent stylet 928 from entering so far into guide wire lumen 844 of shaft 830 that it cannot be withdrawn therefrom. The coiled tip portion of stylet 928 is also configured to provide a handle for gripping stylet 928 and withdrawing it from catheter assembly 900 prior to use of catheter assembly 900.

[0057] As shown contrastively between FIGS. 10 and 11, tip component 104 of balloon protector 100 and its tapered portion 114 advantageously facilitate gripping stylet 928 and withdrawing it from catheter assembly 900. This can be difficult in a catheter assembly such as that of FIG. 11. For example, the catheter assembly of FIG. 11 has a balloon protector with a flared tip portion rather than a tapered tip portion such as balloon protector 100. The coiled tip portion of stylet 928 can be wound and hidden within the flared tip portion of the balloon protector of the catheter assembly of FIG. 11, making it difficult to grip stylet 928 and withdraw it from the catheter assembly. However, due to the configuration of tip component 104, the coiled tip portion of stylet 928 remains exposed, thereby facilitating gripping stylet 928 and withdrawing it from catheter assembly 900.

[0058] Catheter assembly 900 can be sterilized and packaged and ready for immediate use. Method Method catheter assembly 900 includes a method of using catheter assembly 900.

[0059] For example, the method of using catheter assembly 900 includes a removal step of removing catheter assembly 900 from a package containing catheter assembly 900. For this exemplary method, catheter assembly 900 includes balloon catheter 800, balloon protector 100, and stylet 928. Balloon catheter 800 includes a shaft 830 having a guide wire lumen 844 and an uninflated balloon 832 disposed 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 a tip component 104 of balloon protector 100 coupled to a distal portion of a body component 102 of balloon protector 100. Stylet 928 is disposed within guide wire lumen 844 of shaft 830 of balloon catheter 800 to maintain the integrity of catheter assembly 900 during transportation or pre-operative handling. Stylet 928 has a coiled distal portion extending from an opening of a distal tip 116 of tip component 104 of balloon protector 100.

[0060] The method includes a withdrawal step of withdrawing stylet 928 from catheter assembly 900 after the removal step. The withdrawal step includes withdrawing stylet 928 from catheter assembly 900 by the coiled distal portion of stylet 928.

[0061] The method includes a threading step of threading a proximal end portion of a guide wire through an opening of a distal tip 116 of tip component 104 of balloon protector 100 and into guide wire lumen 844 of balloon catheter 800. The distal end portion of the guide wire is typically already disposed around a stenotic or occluded portion of a blood vessel within a patient's vasculature that requires balloon angioplasty.

[0062] Although not specifically shown, a comparison between FIGS. 10 and 11 will be made regarding how the tip component 104 of the balloon protector 100 and its tapered portion 114 advantageously facilitate the threading process, which can be difficult in a catheter assembly such as the catheter assembly of FIG. 11. As described above, the catheter assembly of FIG. 11 has a balloon protector with a flared tip portion rather than a tapered tip portion such as the balloon protector 100. The flared tip portion of the balloon protector may conceal the tip portion of the shaft of the balloon catheter and the opening of its guide wire lumen, increasing the number of passes and making the threading process difficult. In fact, clinicians often remove such a balloon protector before it is desired to remove it to perform the threading process, which exposes the balloon of the balloon catheter to fluids (e.g., saline, body fluids, etc.), wet instruments, wet hands, etc. However, due to the configuration of the tip component 104, the opening 118 of the tip-side tip 116 of the tip component 104 remains exposed, facilitating the threading process (i.e., passing the proximal end portion of the guide wire through the opening 118 of the tip-side tip 116 of the tip component 104 of the balloon protector 100 into the guide wire lumen 844 of the balloon catheter 800). Of course, the tapered portion 114 of the tip component 104 has an inner diameter taper corresponding to the outer diameter of the tip-side shoulder 838 of the balloon 832, thereby maintaining concentricity between the opening 118 of the tip-side tip 116 of the tip component 104 and the opening at the tip of the shaft 830 of the balloon catheter 800, thereby further facilitating the threading process.

[0063] The method includes a catheter assembly advancing step of advancing the catheter assembly 900 on the guide wire to the opening at the proximal end of the introducer sheath. As described above, the tip component 104 of the balloon protector 100 has an overlap portion 112 having an outer diameter larger than the outer diameter of the immediately proximal side portion of the balloon covering section 106 of the balloon protector 100 on the tip end portion of the main body component 102 of the balloon protector 100. The overlap portion 112 is configured to stop the advancement of the catheter assembly 900 to the introducer sheath with the balloon protector 100 covering the balloon 832.

[0064] The method includes a peeling step of peeling the balloon protector 100 from the balloon catheter 800 by continuously pulling the pair of tabs 122 of the tabbed section 110 of the balloon protector 100 away from each other to gradually separate the balloon protector 100. As described above, both the main body component 102 and the tip component 104 of the balloon covering section 106 of the balloon protector 100 include a pair of weak lines 124 and 126 aligned with the tabs 122. The balloon covering section 106 is configured to separate along each of the weak lines 124 and 126.

[0065] The method may further include a balloon catheter advancing step of advancing the balloon 832 of the balloon catheter 800 on the guide wire to the stenotic or occluded portion of the blood vessel that requires balloon angioplasty.

[0066] The method may include an expanding step of expanding the balloon 832 to widen the stenotic or occluded portion of the blood vessel. As described above, the balloon catheter 800 includes a branch hub 834 on the proximal end portion of the shaft 830. The branch hub 834 includes an expansion port 840 fluidly connected to the balloon 832 through the expansion lumen of the shaft 830. The expansion port 840 is used in the expanding step.

[0067] Some specific embodiments are disclosed herein, and while the specific embodiments are disclosed to some extent, it is not intended to limit the scope of the concepts provided herein. Additional improvements and / or modifications may be apparent to those skilled in the art, and in a broader sense, these improvements and / or modifications are similarly included. Thus, it is possible to depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A balloon protector, comprising a balloon covering section including a tip component of the balloon protector coupled to a tip end portion of a body component of the balloon protector and configured to cover a drug-coated balloon of a balloon catheter, and a tabbed section on a proximal end side of the balloon covering section, the tabbed section including a pair of tabs configured to be continuously pulled away from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon. The tip component has a tapered portion having an inner diameter taper corresponding to an outer diameter of a tip side shoulder of the balloon. The balloon protector, wherein the inner diameter taper of the tip component is configured to maintain concentricity between an opening at a tip end of the tip component and an opening at a tip end of a shaft of the balloon catheter for passing a guide wire.

2. A balloon protector, comprising a balloon covering section including a tip component of the balloon protector coupled to a tip end portion of a body component of the balloon protector and configured to cover a drug-coated balloon of a balloon catheter, and a tabbed section on a proximal end side of the balloon covering section, the tabbed section including a pair of tabs configured to be continuously pulled away from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon. The tip component has an overlapping portion on the tip end portion of the body component and having an outer diameter larger than an outer diameter of a portion immediately proximal to the balloon covering section. The balloon protector, wherein the outer diameter of the overlapping portion of the tip component is configured to provide a stop for preventing insertion of the balloon catheter into an introducer sheath while the balloon protector covers the balloon.

3. The tip component has an overlapping portion on the tip end portion of the body component and having an outer diameter larger than an outer diameter of a portion immediately proximal to the balloon covering section. The outer diameter of the overlapping portion of the chip component is configured to provide a stop to prevent insertion of the balloon catheter into the introducer sheath while the balloon protector covers the balloon, the balloon protector according to claim 1.

4. The chip component includes longitudinal gaps in each of two opposing side portions of the balloon protector, The longitudinal gaps are configured to allow separation of the tip portion of the body component along the tip of the body component without an increase in the applied peeling force, having a length greater than or equal to the length of the overlapping portion of the chip component, the balloon protector according to claim 2 or 3.

5. The length of the longitudinal gap exceeds the length of the overlapping portion of the chip component, thereby forming a through hole between the tip of the longitudinal gap and the tip of the body component, the balloon protector according to claim 4.

6. The through hole is configured to provide interruption of the applied peeling force when separating the balloon protector along the balloon covering section, The interruption indicates separation through the tip of the body component, the balloon protector according to claim 5.

7. Both the body component and the chip component of the balloon covering section include a pair of opposing longitudinal weak lines aligned with the tab, The balloon covering section is configured to separate along each of the weak lines, the balloon protector according to any one of claims 1 to 6.

8. The balloon covering section further includes a transition section configured to cover the proximal shoulder of the balloon, The transition section has an outer diameter flare configured to increase the distance between the tabs from the immediate tip side portion of the balloon covering section to the tip of the tabbed section to make gripping of the tabs easier, the balloon protector according to any one of claims 1 to 7.

9. 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 are textured to make gripping of the tab easier, the balloon protector according to any one of claims 1 to 8.

10. A catheter assembly, A balloon catheter, A shaft, A balloon catheter comprising a non-expanded drug coating balloon disposed around a tip portion of the shaft. A balloon protector including a balloon covering section that covers the balloon, the balloon covering section including a tip component of the balloon protector coupled to a tip portion of a body component of the balloon protector. A tabbed section on a proximal end side of the balloon covering section, the tabbed section including a pair of tabs configured to be continuously pulled away from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon. The tip component has a tapered portion having an inner diameter taper corresponding to an outer diameter of a tip side shoulder of the balloon. The inner diameter taper of the tip component is configured to maintain concentricity between an opening at a tip of the tip component and an opening at a tip of the balloon catheter for passing a guide wire. A catheter assembly. **Claim 11** A catheter assembly, A balloon catheter, A shaft, A balloon catheter including a non-expanded drug coating balloon disposed around a tip portion of the shaft. A balloon protector including a balloon covering section that covers the balloon, the balloon covering section including a tip component of the balloon protector coupled to a tip portion of a body component of the balloon protector. A tabbed section on a proximal end side of the balloon covering section, the tabbed section including a pair of tabs configured to be continuously pulled away from each other to gradually separate the balloon protector along the balloon covering section until the balloon protector is completely detached from the balloon. The tip component has an overlapping portion on the tip portion of the body component, the overlapping portion having an outer diameter larger than an outer diameter of a portion immediately proximal to the balloon covering section. The outer diameter of the overlapping portion of the tip component is configured to provide a stop for preventing insertion of the balloon catheter into an introducer sheath while the balloon protector covers the balloon. A catheter assembly. **Claim 12** The catheter assembly further includes a stylet disposed within the guidewire lumen of the shaft of the balloon catheter so as to maintain the integrity of the catheter assembly during transportation or preoperative handling of the catheter assembly. The catheter assembly according to claim 10, wherein the stylet has a coiled tip portion extending from the opening at the tip of the tip component of the balloon protector and is configured to be gripped for pulling the stylet out of the catheter assembly.

13. The tip component has an overlap portion on the tip portion of the body component and has an outer diameter larger than the outer diameter of the immediate proximal side portion of the balloon covering section. The catheter assembly according to claim 10 or 12, wherein the outer diameter of the overlap portion of the tip component is configured to provide a stop for preventing insertion of the balloon catheter into the introducer sheath while the balloon protector covers the balloon.

14. The tip component includes longitudinal gaps in each of two opposing side portions of the balloon protector. The catheter assembly according to claim 11 or 13, wherein the longitudinal gap has a length greater than or equal to the length of the overlap portion of the tip component and enables separation of the tip portion of the body component across the tip of the body component without an accompanying increase in the applied peeling force.

15. The catheter assembly according to claim 14, wherein the length of the longitudinal gap exceeds the length of the overlap portion of the tip component, thereby forming a through hole between the tip of the longitudinal gap and the tip of the body component.

16. The through hole is configured to provide interruption of the applied peeling force when separating the balloon protector along the balloon covering section. The catheter assembly according to claim 15, wherein the interruption indicates separation through the tip of the body component.

17. Both the body component and the tip component of the balloon covering section include a pair of opposing longitudinal weak lines aligned with the tabs. The catheter assembly according to any one of claims 10 to 16, wherein the balloon covering section is configured to separate along each of the weak lines.

18. The balloon covering section further includes a transition section configured to cover the proximal shoulder of the balloon. The transition section has an outer diameter flare configured to increase the distance between the tabs from the immediate distal portion of the balloon covering section to the distal end of the tabbed section to facilitate gripping of the tabs, the catheter assembly according to any one of claims 10 to 17. **Claim 19** 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 are textured to include those that facilitate gripping of the tab, the catheter assembly according to any one of claims 10 to 18. **Claim 20** The balloon catheter further includes a bifurcation hub around the proximal end portion of the shaft. The bifurcation hub has an inflation port fluidly connected to the balloon via the expanded lumen of the shaft, the catheter assembly according to any one of claims 10 to 19.

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