Patent Description:
Atherosclerosis is characterized by one or more intravascular lesions formed in part of plaque including blood-borne substances such as fat, cholesterol, and calcium. An intravascular lesion such as an arterial lesion can form on a wall of an arterial lumen and build out across the lumen to an opposite wall thereof. A last point of patency often occurs at a 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 to the 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, which is needed to maintain integrity of the balloon catheters for the surgical procedures for which they are designed. In addition, balloon protectors protect clinicians and others from inadvertently coming into contact with anti-proliferative drugs of the drug-coated balloons when handling the balloon catheters before the surgical procedures. While the foregoing needs for balloon protectors continue to exist, additional needs exist such as a need to safeguard against advancing a balloon catheter through an introducer sheath without first removing the balloon protector thereof.

<CIT> discloses a balloon protector for the balloon of a dilatation catheter including a distally extending flared section that defines a funnel receptive to a guidewire in order to facilitate backloading of the guidewire into the catheter. <CIT> discloses a peelable protective sheath for protecting balloon of angioplasty dilatation catheter for treating blockages in arteries of patient, has tab extending axially from body portion and including textured surface on side facing away from axis.

Disclosed herein are balloon protectors, balloon catheters including the balloon protectors, and methods thereof that meet or exceed the foregoing needs.

The present invention is directed to the catheter assembly of claim <NUM>. The dependent claims refer to preferred embodiments.

Disclosed herein is a balloon protector for a balloon catheter. The balloon protector includes a balloon-covering section and a tabbed section proximal of the balloon-covering section. The balloon-covering section is configured to cover a drug-coated balloon of the balloon catheter. The balloon-covering section includes a tip piece of the balloon protector. The tabbed section includes a pair of tabs configured to be continuously pulled away from each other to progressively split the balloon protector along the balloon-covering section until the balloon protector is completely peeled off the balloon.

In some embodiments, the tip piece has a tapered portion having an inner-diameter taper (configured to be) commensurate with an outer diameter of a distal shoulder of the balloon. The inner-diameter taper of the tip piece is configured to maintain concentricity between an opening in a distal end of the tip piece and an opening in a distal end of a shaft of the balloon catheter for threading a guidewire therethrough.

In some embodiments, 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 an outer diameter greater than that of an immediately proximal portion of the balloon-covering section. The outer diameter of the overlapping portion of the tip piece is configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon.

In some embodiments, the tip piece includes a longitudinal gap on each side of two opposing sides of the balloon protector. The longitudinal gap has a length greater than or equal to that of the overlapping portion of the tip piece. The balloon protector is configured such that the length of the longitudinal gap allows the distal-end portion of the body piece to be split through a distal end of the body piece without an increase in applied peel force.

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

In some embodiments, the balloon protector is configured such that the through hole is configured to provide a break in the applied peel force when splitting the balloon protector along the balloon-covering section, the break signaling splitting through the distal end of the body piece.

In some embodiments, both the body piece and the tip piece of the balloon-covering section include a pair of opposing longitudinal lines of weakness aligned with the tabs. The balloon protector is configured such that the balloon-covering section is configured to split along each line of the lines of weakness.

In some embodiments, the balloon-covering section further includes a transitional section configured to cover a proximal shoulder of the balloon. The transitional section has an outer-diameter flare from an (immediately) distal portion of the balloon-covering section to a distal end of the tabbed section. The outer-diameter flare is configured to increase a distance between the tabs. This is optional for making the tabs easier to grasp.

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 optional for making the tabs easier to grasp.

The catheter assembly of claim <NUM> includes a balloon catheter and a balloon protector. The balloon catheter includes a shaft and a drug-coated balloon in an uninflated state disposed about a distal-end portion of the shaft. The balloon protector can be the balloon protector of any of the foregoing paragraphs [<NUM>] to [<NUM>]. The balloon protector includes a balloon-covering section and a tabbed section proximal of the balloon-covering section. The balloon-covering section covers the balloon of the balloon catheter. The balloon-covering section includes a tip piece of the balloon protector coupled to a distal-end portion of a body piece of the balloon protector. The tabbed section includes a pair of tabs configured to be continuously pulled away from each other to progressively split the balloon protector along the balloon-covering section until the balloon protector is completely peeled off the balloon.

According to claim <NUM>, the tip piece has a tapered portion having an inner-diameter taper commensurate with an outer diameter of a distal shoulder of the balloon. The inner-diameter taper of the tip piece is configured to maintain concentricity between an opening in a distal end of the tip piece and an opening in a distal end of a shaft of the balloon catheter for threading a guidewire therethrough.

In some embodiments, the catheter assembly further includes a stylet disposed in a guidewire lumen of the shaft of the balloon catheter such that the catheter assembly is configured to maintain integrity of the catheter assembly during shipping or preoperative handling. The stylet has a coiled distal-end portion extending from the opening in the distal end of the tip piece of the balloon protector configured to be grasped for pulling the stylet out of the catheter assembly.

In some embodiments, the tip piece has an overlapping portion over the distal-end portion of the body piece. The overlapping portion has an outer diameter greater than that of an immediately proximal portion of the balloon-covering section. The outer diameter of the overlapping portion of the tip piece is configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon.

In some embodiments, the tip piece includes a longitudinal gap on each side of two opposing sides of the balloon protector. The longitudinal gap has a length greater than or equal to that of the overlapping portion of the tip piece. The length of the longitudinal gap allows the distal-end portion of the body piece to be split through a distal end of the body piece without an increase in applied peel force.

In some embodiments, the length of the longitudinal gap is greater than that of the overlapping portion of the tip piece. Due to the length of the longitudinal gap, a through hole is formed between a distal end of the longitudinal gap and the distal end of the body piece.

In some embodiments, the through hole is configured to provide a break in the applied peel force when splitting the balloon protector along the balloon-covering section, the break signaling splitting through the distal end of the body piece.

In some embodiments, both the body piece and the tip piece of the balloon-covering section include a pair of opposing longitudinal lines of weakness aligned with the tabs. The balloon-covering section is configured to split along each line of the lines of weakness.

In some embodiments, the balloon-covering section further includes a transitional section configured to cover a proximal shoulder of the balloon. The transitional section has an outer-diameter flare from an immediately distal portion of the balloon-covering section to a distal end of the tabbed section. The outer-diameter flare is configured to increase a distance between the tabs making the tabs easier to grasp.

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 making the tabs easier to grasp.

In some embodiments, the balloon catheter further includes a bifurcated hub about a proximal-end portion of the shaft. The bifurcated hub has an inflation port fluidly connected to the balloon by way of an inflation lumen of the shaft.

Also disclosed herein is a method of a catheter assembly including, in some embodiments, a removing step of removing the catheter assembly from a catheter-assembly package. The catheter assembly can be a catheter assembly of any of the preceding paragraphs [<NUM>] to [<NUM>]. For example, the catheter assembly includes a balloon catheter, a balloon protector, and a stylet. The balloon catheter includes a shaft having a guidewire lumen and a drug-coated balloon in an uninflated state disposed about a distal-end portion of the shaft. The balloon protector can be a balloon protector of any of the preceding paragraphs [<NUM>] to [<NUM>]. For example, the balloon protector includes a balloon-covering section covering the balloon. The balloon-covering section includes a tip piece of the balloon protector coupled to a distal-end portion of a body piece of the balloon protector. The stylet is disposed in the guidewire lumen of the shaft of the balloon catheter. The stylet has a coiled distal-end portion extending from an opening in a distal end of the tip piece of the balloon protector. The method also includes a pulling step of pulling the stylet out of the catheter assembly by the coiled distal-end portion. The method also includes a threading step of threading a proximal-end portion of a guidewire through the opening in the distal end of the tip piece of the balloon protector and into the guidewire lumen of the balloon catheter.

In the invention, the tip piece of the balloon protector has a tapered portion having an inner-diameter taper commensurate with an outer diameter of a distal shoulder of the balloon. The inner-diameter taper of the tip piece is configured to maintain concentricity between the opening in the distal end of the tip piece and an opening in a distal end of the shaft of the balloon catheter. Maintaining concentricity facilitates the threading of the guidewire into the guidewire lumen of the balloon catheter.

In some examples, a distal-end portion of the guidewire is disposed in a blood vessel of a patient about a narrowed or obstructed portion of the blood vessel in need of balloon angioplasty.

In some examples, the method further includes a balloon-catheter advancing step of advancing the balloon catheter over the guidewire to the narrowed or obstructed portion of the blood vessel in need of balloon angioplasty. The method also includes an inflating step of inflating the balloon to widen the narrowed or obstructed portion of the blood vessel. The balloon catheter includes a bifurcated hub over a proximal-end portion of the shaft including an inflation port fluidly connected to the balloon by way of an inflation lumen of the shaft.

In some examples, the method further includes a catheter-assembly advancing step of advancing the catheter assembly over the guidewire up to an opening in a 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 an outer diameter greater than that of an immediately proximal portion of the balloon-covering section. The overlapping portion is configured to stop the advancing of the catheter assembly into the introducer sheath with the balloon protector covering the balloon.

In some examples, the method further includes a peeling step of peeling the balloon protector off the balloon catheter by continuously pulling a pair of tabs away from each other to progressively split the balloon protector. The balloon protector includes a tabbed section proximal of the balloon-covering section including the pair of tabs.

In some examples, both the body piece and the tip piece of the balloon-covering section of the balloon protector include a pair of opposing longitudinal lines of weakness aligned with the tabs. The balloon-covering section is configured to split along each line of the lines of weakness.

These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

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 particular fixed location, orientation, or direction.

With respect to "proximal," a "proximal portion" or a "proximal-end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on 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 on 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 on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to "distal," a "distal portion" or a "distal-end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, 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 on 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 on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

Again, balloon protectors are designed to cover and protect the drug-coated balloons of balloon catheters during shipping or preoperative handling, which is needed to maintain integrity of the balloon catheters for the surgical procedures for which they are designed. In addition, balloon protectors protect clinicians and others from inadvertently coming into contact with anti-proliferative drugs of the drug-coated balloons when handling the balloon catheters before the surgical procedures. While the foregoing needs for balloon protectors continue to exist, additional needs exist such as a need to safeguard against advancing a balloon catheter through an introducer sheath without first removing the balloon protector thereof.

<FIG> illustrate side and top or bottom views of a balloon protector <NUM> in accordance with some embodiments. <FIG> illustrate detailed side and top or bottom views of a distal-end portion of the balloon protector <NUM> in accordance with some embodiments. <FIG> illustrates a longitudinal cross section of the distal-end portion of the balloon protector <NUM>; <FIG> illustrates a transverse cross section of the distal-end portion of the balloon protector where a tip piece <NUM> overlaps a distal-end portion of a body piece <NUM>; and <FIG> illustrates a transverse cross section of a distal-end portion of the tip piece <NUM> of the balloon protector <NUM> in accordance with some embodiments.

The balloon protector <NUM> is configured to cover and protect a drug-coated balloon of a balloon catheter (e.g., the balloon catheter <NUM> of <FIG>) during shipping or preoperative handling, which is needed to maintain integrity of the balloon catheter for the surgical procedures for which it is designed.

As shown, the balloon protector <NUM> includes the body piece <NUM> and the tip piece <NUM> coupled to a distal-end portion of the body piece <NUM>. Each piece of the body piece <NUM> and the tip piece <NUM> is unitary in that it is one continuous piece. A balloon-covering section <NUM> of the balloon protector <NUM> includes the tip piece <NUM> and a distal portion of the body piece <NUM>. The balloon-covering section <NUM> also includes a transitional section <NUM> of the body piece <NUM> opposite the tip piece <NUM>. A tabbed section <NUM> of the balloon protector <NUM> includes a proximal portion of the body piece <NUM>.

The balloon-covering section <NUM> is configured to cover a balloon of a balloon catheter, which balloon is typically disposed about a distal-end portion of a shaft of the balloon catheter. The balloon-covering section <NUM> is configured to cover the balloon of such a balloon catheter with at least a clearance fit (e.g., a sliding fit, location fit, etc.) up to a transition fit (e.g., tight fit), thereby holding the balloon in an uninflated, folded configuration without compressing the balloon up to minimally compressing the balloon. With respect to the clearance fit, the balloon-covering section <NUM> of the balloon protector <NUM> has an inner diameter minimally larger than an outer diameter of the balloon in the uninflated, folded configuration. With respect to the transition fit, the inner diameter of the balloon-covering section <NUM> is negligibly larger than the outer diameter of the balloon in the uninflated, folded configuration. (See International Organization for Standardization ["ISO"] <NUM> for such tolerances.

The tip piece <NUM> of the balloon protector <NUM> is configured to cover a distal shoulder of a balloon of a balloon catheter, which shoulder typically does not include a drug coating. The tip piece <NUM> is coupled (e.g., adhered, solvent bonded, heat welded, etc.) to a distal-end portion of the body piece <NUM> of the balloon protector <NUM> such that the tip piece <NUM> has an overlapping portion <NUM> over the distal-end portion of the body piece <NUM>. The overlapping portion <NUM> has an outer diameter greater than that of an immediately proximal portion of the balloon-covering section <NUM> of the balloon protector <NUM>. The outer diameter of the overlapping portion <NUM> of the tip piece <NUM> is configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector <NUM> is covering the balloon. The stop is advantageous in that it is preferential to leave a balloon protector over a balloon of a balloon catheter up until the very moment the balloon catheter is inserted into the introducer sheath in order to protect the balloon from fluids (e.g., saline, bodily fluids, etc.), wet instruments, wet hands, or the like. The stop allows a clinician to leave the balloon protector over the balloon of the balloon catheter as long as desired without a risk of inadvertently inserting the balloon catheter into the introducer sheath while the balloon protector <NUM> is covering the balloon.

The tip piece <NUM> has a tapered portion <NUM> tapering from the overlapping portion <NUM> of the tip piece <NUM> to a distal tip <NUM> of the tip piece <NUM>. The tapered portion <NUM> of the tip piece <NUM> has an inner-diameter taper commensurate with an outer diameter of a distal shoulder of a balloon of a balloon catheter. The inner-diameter taper of the tapered portion <NUM> is configured to maintain concentricity between an opening <NUM> in the distal tip <NUM> and an opening in a distal end of a shaft of the balloon catheter for threading a guidewire therethrough. The tapered portion <NUM> also has an outer-diameter taper. Depending upon the outer diameter of the overlapping portion <NUM> of the tip piece <NUM>, a length of the tip piece <NUM>, or the like, the outer-diameter taper can be greater than, equal to, or less than the inner-diameter taper. The outer-diameter taper is greater than the inner-diameter taper of the balloon protector <NUM> shown in <FIG>. As set forth herein below, the tip piece <NUM> and the tapered portion <NUM> thereof facilitate stylet removal.

The tip piece <NUM> includes a longitudinal gap <NUM> on each side of two opposing sides of the balloon protector <NUM>. The longitudinal gap <NUM> of the tip piece <NUM> has a length equal to or greater than that of the overlapping portion <NUM> of the tip piece <NUM> as measured from a proximal end of the tip piece <NUM>. The length of the longitudinal gap <NUM> allows the distal-end portion of the body piece <NUM> of the balloon protector <NUM> to be split through a distal end thereof without the increase in applied peel force that would otherwise be required to split through both the overlapping portion <NUM> of the tip piece <NUM> and the distal-end portion of the body piece <NUM> thereunder. The length of the longitudinal gap <NUM> in the embodiment of the balloon protector <NUM> shown in at least <FIG>, <FIG>, and <FIG> is greater than that of the overlapping portion <NUM>. In such embodiments, a window or through hole <NUM> is formed between a distal end of the longitudinal gap <NUM> and the distal end of the body piece <NUM>. The through hole <NUM> advantageously provides a momentary break in the applied peel force (e.g., ~<NUM> lbf to <NUM> lbf) when splitting the balloon protector <NUM> in a distal direction along the balloon-covering section <NUM> thereof. The break signals the distal end of the body piece <NUM> has been split through, which, in turn, signals near completion of the splitting with commencement of the splitting through the tip piece <NUM>.

The transitional section <NUM> of the balloon protector <NUM> is configured to cover a proximal shoulder of a balloon of a balloon catheter, which shoulder typically does not include a drug coating. The transitional section <NUM> has a flare in at least an outer diameter thereof from an immediately distal portion of the balloon-covering section <NUM> of the balloon protector <NUM> to a distal end of the tabbed section <NUM> of the balloon protector <NUM>. The flare of the transitional section <NUM> is configured to increase a distance between each tab of a pair of tabs <NUM> of the tabbed section <NUM> of the balloon protector <NUM>, thereby making the tabs <NUM> easier to grasp for splitting the balloon protector <NUM>. The flare of the transitional section <NUM> is also configured to facilitate manufacturing of catheter assemblies such as the catheter assembly <NUM> set forth below. Indeed, the flare of the transitional section <NUM> ensures the drug coating <NUM> of the balloon <NUM> is not unnecessarily scraped off when the balloon protector <NUM> is disposed over the balloon <NUM>. In addition, the transitional section <NUM> minimizes any potential for damage of the balloon <NUM> while in the uninflated state.

The tabbed section <NUM> of the balloon protector <NUM> includes the pair of tabs <NUM>, which tabs <NUM> are configured to provide a starting point from which to split the balloon-covering section <NUM> of the balloon protector <NUM> along the pairs of lines of weakness <NUM> and <NUM> set forth below. Indeed, the tabs <NUM> are configured to be grasped and continuously pulled away from each other to progressively split the balloon protector <NUM> in a distal direction along the balloon-covering section <NUM> of the balloon protector <NUM> until the balloon protector <NUM> is completely peeled off a balloon of a balloon catheter. Like the flare of the transitional section <NUM> of the balloon protector <NUM>, the tabbed section <NUM> has a flare configured to increase a distance between each tab of the pair of tabs <NUM> of the tabbed section <NUM>, thereby making the tabs <NUM> easier to grasp for splitting the balloon protector <NUM>. In addition, each tab of the pair of tabs <NUM> includes an inner surface 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 <NUM> easier to grasp for splitting the balloon protector <NUM>. In the embodiment of the balloon protector <NUM> shown in at least <FIG>, and <FIG>, both the inner surface and the outer surface of each tab of the pair of tabs <NUM> is textured.

The body piece <NUM> along the balloon-covering section <NUM> of the balloon protector <NUM> includes a pair of opposing longitudinal lines of weakness <NUM> aligned with the tabs <NUM>, along which the body piece <NUM> is configured to split. Likewise, the tip piece <NUM> of the balloon-covering section <NUM> of the balloon protector <NUM> includes a pair of opposing longitudinal lines of weakness <NUM> aligned with the tabs <NUM>, along which the tip piece <NUM> is configured to split. Notably, each line of weakness of the lines of weakness <NUM> of the body piece <NUM> extends into the longitudinal gap <NUM> of the tip piece <NUM> through the distal end of the body piece <NUM>. Each line of weakness of the lines of weakness <NUM> of the tip piece <NUM> extends from the distal end of the longitudinal gap <NUM> of the tip piece <NUM> through a distal end of the distal tip <NUM> of the tip piece <NUM>. Should the through hole <NUM> be present in each side of the balloon protector <NUM>, the through holes provide breaks between the lines of weakness <NUM> and the lines of weakness <NUM>. The lines of weakness <NUM> and <NUM> can be scores or perforations along the balloon-covering section <NUM>, wherein the perforations include a series of longitudinal slits akin to a dashed line, a series of through holes akin to a dotted line, or a combination thereof.

In an alternative to the foregoing, the body piece <NUM> of the balloon protector <NUM> lacks the pair of lines of weakness <NUM>, the tip piece <NUM> of the balloon protector <NUM> lacks the pair of lines of weakness <NUM>, or both the body piece <NUM> and the tip piece <NUM> lack their respective pair of lines of weakness. Instead, the body piece <NUM>, the tip piece <NUM>, or each piece of the body piece <NUM> and the tip piece <NUM>, as the case might be, is formed of a polymeric material in which main chains of the polymeric material are oriented along a length of the body piece <NUM> or the tip piece <NUM>. The main chains of the polymeric material are configured to facilitate splitting from a starting point provided by, for example, the pair of tabs <NUM> when pulled away from each other, through a remainder of the body piece <NUM> or the tip piece <NUM> without transversely tearing the body piece <NUM> or the tip piece <NUM>.

Each piece of the body piece <NUM> and the tip piece <NUM> of the balloon protector <NUM> can be of a polymeric material including, but not limited to, high-density polyethylene ("HDPE") or expanded polytetrafluoroethylene ("ePTFE"). When either the body piece <NUM> or the tip piece <NUM> is of ePTFE, main chains of the ePTFE can be oriented along the length of the body piece <NUM> or the tip piece <NUM> to facilitate splitting thereof without the pair of lines of weakness <NUM> or <NUM> as set for the above. When the body piece <NUM> or the tip piece <NUM> is molded from the polymeric material, the body piece <NUM> or the tip piece <NUM> is characteristic of the molding process used such as injection molding, extrusion molding, compression molding, bladder molding, or the like.

<FIG> illustrates a balloon catheter <NUM> in accordance with some embodiments. <FIG> illustrates a catheter assembly <NUM> including the balloon catheter <NUM> and the balloon protector <NUM> in accordance with some embodiments. <FIG> illustrates a detailed side view of the catheter assembly <NUM> including a stylet <NUM> in accordance with some embodiments.

The catheter assembly <NUM> includes the balloon catheter <NUM>, the balloon protector <NUM>, and, optionally, the stylet <NUM> to maintain integrity of the catheter assembly <NUM> during shipping or preoperative handling.

The balloon catheter <NUM> includes a shaft <NUM>, a balloon <NUM> in an uninflated state disposed about a distal-end portion of the shaft <NUM>, and a bifurcated hub <NUM> about a proximal-end portion of the shaft <NUM>.

The balloon <NUM> of the balloon catheter <NUM> can be a drug-coated balloon, wherein a drug coating <NUM> of the balloon <NUM> is a coating of an anti-proliferative or anti-restenotic drug such as paclitaxel or rapamycin. The balloon <NUM> includes a proximal shoulder <NUM> and a distal shoulder <NUM>, between which shoulders <NUM> and <NUM> the drug coating <NUM> of the balloon <NUM> is typically applied. That is, the proximal shoulder <NUM> and the distal shoulder <NUM> of the balloon <NUM> do not typically include the drug coating <NUM>. This is because the proximal and distal shoulders <NUM> and <NUM> are not typically placed in apposition to an arterial-lumen wall during a surgical intervention for atherosclerosis. Notwithstanding the foregoing, the balloon <NUM> need not include the drug coating <NUM> in some embodiments.

The bifurcated hub <NUM> has an inflation port <NUM> fluidly connected to the balloon <NUM> of the balloon catheter <NUM> by way of an inflation lumen of the shaft <NUM> of the balloon catheter <NUM>. The bifurcated hub <NUM> also has a guidewire port <NUM> connected to a guidewire lumen <NUM> extending along an entire length of the shaft <NUM> to an opening in a distal end of a shaft <NUM>. <FIG> and <FIG> show the stylet <NUM> within at least a distal-end portion of the guidewire lumen <NUM> of the shaft <NUM>.

The balloon protector <NUM> is described as set forth above, which includes details with respect to configuration of the balloon protector <NUM> over a balloon of a balloon catheter such as the balloon catheter <NUM>, as well as details for how the balloon protector <NUM> is configured to be removed from such a balloon catheter.

The stylet <NUM>, when present in the catheter assembly <NUM>, is disposed within both the tip piece <NUM> of the balloon protector <NUM> and the guidewire lumen <NUM> of the shaft <NUM> of the balloon catheter <NUM> to maintain the integrity of the catheter assembly <NUM> during shipping or preoperative handling thereof, for example, to prevent collapse of the guidewire lumen <NUM> of the shaft <NUM>. The stylet <NUM> can be metal (e.g., stainless steel) with a coiled distal-end portion extending from the opening in the distal tip <NUM> of the tip piece <NUM> of the balloon protector <NUM> configured to prevent the stylet <NUM> from irretrievably slipping into the guidewire lumen <NUM> of the shaft <NUM>. The coiled distal-end portion of the stylet <NUM> is also configured to provide a handle for grasping and pulling the stylet <NUM> out of the catheter assembly <NUM> before use of the catheter assembly <NUM>.

As shown by contrast between <FIG>, the tip piece <NUM> of the balloon protector <NUM> and the tapered portion <NUM> thereof advantageously facilitates grasping and pulling the stylet <NUM> out of the catheter assembly <NUM>, which can be difficult with catheter assemblies such as that of <FIG>. For example, the catheter assembly of <FIG> has a balloon protector with a flared distal-end portion - not a tapered distal-end portion like that of the balloon protector <NUM>. The coiled distal-end portion of the stylet <NUM> can coil into and conceal itself in the flared distal-end portion of the balloon protector of the catheter assembly of <FIG> making it difficult to grasp and pull the stylet <NUM> out of the catheter assembly. Due to the configuration of the tip piece <NUM>, however, the coiled distal-end portion of the stylet <NUM> remains exposed, thereby facilitating the grasping and pulling of the stylet <NUM> out of the catheter assembly <NUM>.

The catheter assembly <NUM> can be sterilely packaged and ready for immediate use.

Methods the catheter assembly <NUM> include a method of using the catheter assembly <NUM>.

For example, the method of using the catheter assembly <NUM> includes a removing step of removing the catheter assembly <NUM> from a package including the catheter assembly <NUM>. For the purpose of this example method, the catheter assembly <NUM> includes the balloon catheter <NUM>, the balloon protector <NUM>, and the stylet <NUM>. The balloon catheter <NUM> includes the shaft <NUM> having the guidewire lumen <NUM> and the balloon <NUM> in an uninflated state disposed about the distal-end portion of the shaft <NUM>. The balloon <NUM> includes the drug coating <NUM> thereon. The balloon protector <NUM> includes the balloon-covering section <NUM> covering the balloon <NUM>. The balloon-covering section <NUM> includes the tip piece <NUM> of the balloon protector <NUM> coupled to the distal-end portion of the body piece <NUM> of the balloon protector <NUM>. The stylet <NUM> is disposed in the guidewire lumen <NUM> of the shaft <NUM> of the balloon catheter <NUM> to maintain integrity of the catheter assembly <NUM> during shipping or preoperative handling. The stylet <NUM> has the coiled distal-end portion extending from the opening in the distal tip <NUM> of the tip piece <NUM> of the balloon protector <NUM>.

The method includes a pulling step of pulling the stylet <NUM> out of the catheter assembly <NUM> after the removing step. The pulling step includes pulling the stylet <NUM> out of the catheter assembly <NUM> by the coiled distal-end portion of the stylet <NUM>.

The method includes a threading step of threading a proximal-end portion of a guidewire through the opening in the distal tip <NUM> of the tip piece <NUM> of the balloon protector <NUM> and into the guidewire lumen <NUM> of the balloon catheter <NUM>. The distal-end portion of the guidewire is typically already disposed in a blood vessel of a patient about a narrowed or obstructed portion of the blood vessel in need of balloon angioplasty.

While not expressly shown, the contrast between <FIG> alludes to how the tip piece <NUM> of the balloon protector <NUM> and the tapered portion <NUM> thereof advantageously facilitates the threading step, which can be difficult with catheter assemblies such as that of <FIG>. As set forth above, the catheter assembly of <FIG> has a balloon protector with a flared distal-end portion - not a tapered distal-end portion like that of the balloon protector <NUM>. The flared distal-end portion of the balloon protector can conceal a distal-end portion of a shaft of a balloon catheter and an opening of a guidewire lumen thereof making the threading step difficult with a lot of poking around. Indeed, clinicians often remove such a balloon protector before it is desired to do so in order to perform the threading step, which risks exposing the balloon of the balloon catheter to fluids (e.g., saline, bodily fluids, etc.), wet instruments, wet hands, or the like. Due to the configuration of the tip piece <NUM>, however, the opening <NUM> in the distal tip <NUM> of the tip piece <NUM> remains exposed, thereby facilitating the threading step (i.e., threading the proximal-end portion of the guidewire through the opening <NUM> in the distal tip <NUM> of the tip piece <NUM> of the balloon protector <NUM> and into the guidewire lumen <NUM> of the balloon catheter <NUM>). Of course, the tapered portion <NUM> of the tip piece <NUM> has the inner-diameter taper commensurate with the outer diameter of the distal shoulder <NUM> of the balloon <NUM>, which maintains concentricity between the opening <NUM> in the distal tip <NUM> of the tip piece <NUM> and the opening in the distal end of the shaft <NUM> of the balloon catheter <NUM>, thereby further facilitating the threading step.

The method includes a catheter-assembly advancing step of advancing the catheter assembly <NUM> over the guidewire up to an opening in a proximal end of an introducer sheath. As set forth above, the tip piece <NUM> of the balloon protector <NUM> has the overlapping portion <NUM> over the distal-end portion of the body piece <NUM> of the balloon protector <NUM> with an outer diameter greater than that of an immediately proximal portion of the balloon-covering section <NUM> of the balloon protector <NUM>. The overlapping portion <NUM> is configured to stop the advancing of the catheter assembly <NUM> into the introducer sheath with the balloon protector <NUM> covering the balloon <NUM>.

The method includes a peeling step of peeling the balloon protector <NUM> off the balloon catheter <NUM> by continuously pulling the pair of tabs <NUM> of the tabbed section <NUM> of the balloon protector <NUM> away from each other to progressively split the balloon protector <NUM>. As set forth above, both the body piece <NUM> and the tip piece <NUM> of the balloon-covering section <NUM> of the balloon protector <NUM> include the pairs of lines of weakness <NUM> and <NUM> aligned with the tabs <NUM>. The balloon-covering section <NUM> is configured to split along each line of the lines of weakness <NUM> and <NUM>.

The method can further include a balloon-catheter advancing step of advancing the balloon <NUM> of the balloon catheter <NUM> over the guidewire to the narrowed or obstructed portion of the blood vessel in need of balloon angioplasty.

The method can include an inflating step of inflating the balloon <NUM> to widen the narrowed or obstructed portion of the blood vessel. As set forth above, the balloon catheter <NUM> includes the bifurcated hub <NUM> over a proximal-end portion of the shaft <NUM> including the inflation port <NUM> fluidly connected to the balloon <NUM> by way of the inflation lumen of the shaft <NUM>, which inflation port <NUM> is used for the inflating step.

Claim 1:
A catheter assembly (<NUM>), comprising:
a balloon catheter (<NUM>) including:
a shaft (<NUM>); and
a drug-coated balloon (<NUM>) in an uninflated state disposed about a distal-end portion of the shaft; and
a balloon protector (<NUM>) including:
a balloon-covering section (<NUM>) covering the balloon (<NUM>), the balloon-covering section (<NUM>) including a tip piece (<NUM>) of the balloon protector (<NUM>) coupled to a distal-end portion of a body piece (<NUM>) of the balloon protector (<NUM>); and
a tabbed section (<NUM>) proximal of the balloon-covering section (<NUM>), the tabbed section including a pair of tabs (<NUM>) configured to be continuously pulled away from each other to progressively split the balloon protector (<NUM>) along the balloon-covering section (<NUM>) until the balloon protector (<NUM>) is completely peeled off the balloon (<NUM>),
wherein the tip piece (<NUM>) has a tapered portion (<NUM>) having an inner-diameter taper commensurate with an outer diameter of a distal shoulder (<NUM>) of the balloon (<NUM>), the inner-diameter taper of the tip piece (<NUM>) configured to maintain concentricity between an opening in a distal end (<NUM>) of the tip piece (<NUM>) and an opening in a distal end of the balloon catheter (<NUM>) for threading a guidewire therethrough.