WO2025255487A1

WO2025255487A1 - Loading tool for drug coated balloon

Info

Publication number: WO2025255487A1
Application number: PCT/US2025/032682
Authority: WO
Inventors: Kaz OHASHI; Cang Lam
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2024-06-07
Filing date: 2025-06-06
Publication date: 2025-12-11
Anticipated expiration: 2026-12-07

Abstract

The present invention relates to a loading tool for a drug-coated balloon catheter, comprising a distal tubular portion, a distal flared portion at the proximal end of the distal tubular portion that increases in diameter in a proximal direction, and a handle portion connected to the distal flared portion. The loading tool facilitates the precise and efficient loading of a drug-coated balloon catheter and removal of the loading tool after the drug coated balloon has been loaded.

Description

LOADING TOOL FOR DRUG COATED BALLOON

RELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63/657,566 filed June 7, 2024 entitled Loading Tool for Drug Coated Balloon, which is hereby incorporated herein by reference in its entirety.

BACKGROUND

[0002] Drug coated balloon catheters are sometimes used to deliver medication to one or more areas of a patient’s vessels. Typically, the catheter’s balloon includes a drug coating on its outer surface. The balloon is advanced within the vasculature of the patient to a desired target area and the balloon is inflated. As the balloon contacts an interior surface of the vessel, the drug coating on the balloon is imparted onto the vessel’s interior surface.

SUMMARY

[0003] In some aspects, the techniques described herein relate to a loading tool for a drug coated balloon catheter, including: a distal tubular portion; a distal flared portion located at a proximal end of the distal tubular portion; the distal flared portion increasing in diameter in a proximal direction; and, a handle portion connected to the distal flared portion.

[0004] In some aspects, the techniques described herein relate to a loading tool, wherein the handle portion includes a proximal tubular portion and a connecting portion that is connected to the distal flared portion and to the proximal tubular portion.

[0005] In some aspects, the techniques described herein relate to a loading tool, wherein the handle portion includes a proximal tubular portion, a proximal flared portion located at a distal end of the proximal tubular portion, and a connecting portion that is connected to the distal flared portion and to the proximal flared portion. [0006] In some aspects, the techniques described herein relate to a loading tool, wherein the handle portion includes a proximal tubular portion and a connecting portion that is connected to the distal flared portion and to the proximal tubular portion.

[0007] In some aspects, the techniques described herein relate to a loading tool, wherein the connecting portion includes an open tubular shape.

[0008] In some aspects, the techniques described herein relate to a loading tool, wherein the connecting portion is angled laterally away from a longitudinal axis of the distal tubular portion.

[0009] In some aspects, the techniques described herein relate to a loading tool, wherein a longitudinal axis of the proximal tubular portion is parallel to the longitudinal axis of the distal tubular portion.

[0010] In some aspects, the techniques described herein relate to a loading tool, further including a slit extending longitudinally through the distal tubular portion and the distal flared portion.

[0011] In some aspects, the techniques described herein relate to a loading tool for a drug coated balloon catheter, including: a distal tubular portion having a first longitudinal axis extending therethrough; a proximal tubular portion having a second longitudinal axis extending therethrough; and, a connecting portion connected to a proximal end of the distal tubular portion and a distal end of the proximal tubular portion; wherein the first longitudinal axis is offset and parallel to the second tubular portion and wherein the connecting portion forms an angle laterally away from the first tubular portion.

[0012] In some aspects, the techniques described herein relate to a loading tool, wherein the distal tubular portion further includes a distal flared portion located at the proximal end of the distal tubular portion.

[0013] In some aspects, the techniques described herein relate to a loading tool, wherein the proximal tubular portion further includes a proximal flared portion located at the distal end of the proximal tubular portion. [0014] In some aspects, the techniques described herein relate to a loading tool, further including a slit extending longitudinally along the distal tubular portion and the distal flared portion.

[0015] In some aspects, the techniques described herein relate to a loading tool, wherein the proximal tubular portion is a closed tube.

[0016] In some aspects, the techniques described herein relate to a loading tool, wherein the connecting portion is an open tubular shape.

[0017] In some aspects, the techniques described herein relate to a loading tool, wherein the connecting portion is an elongated curved shape with a longitudinal groove extending along a length of the connecting portion.

[0018] In some aspects, the techniques described herein relate to a loading tool for a drug coated balloon catheter, including: a distal tubular portion having a first longitudinal axis extending therethrough; a proximal tubular portion having a second longitudinal axis extending therethrough; and, a connecting portion connected to a proximal end of the distal tubular portion and a distal end of the proximal tubular portion; wherein the connecting portion is an elongated curved shape with a longitudinal groove extending along a length of the connecting portion.

[0019] In some aspects, the techniques described herein relate to a loading tool, further including a longitudinal slit extending along a length of the distal tubular portion.

[0020] In some aspects, the techniques described herein relate to a loading tool, wherein the proximal tubular portion is a closed tubular structure.

[0021] In some aspects, the techniques described herein relate to a loading tool, further including a distal flared portion at a proximal end of the distal tubular portion and a proximal flared portion at a distal end of the proximal tubular portion. [0022] In some aspects, the techniques described herein relate to a loading tool for a drug coated balloon catheter, including: a distal tubular portion having a longitudinal slit; and, a handle means for removing the distal tubular portion from a hemostatic valve.

[0023] In some aspects, the techniques described herein relate to a method of using a loading tool, including: placing a distal tubular portion over an uninflated drug coated balloon of a balloon catheter; advancing the distal tubular portion and uninflated drug coated balloon into a hemostatic valve; creating a resistance to distal movement of the distal tubular portion and the uninflated drug coated balloon with a flared portion connected at a proximal end of the distal tubular portion.

[0024] In some aspects, the techniques described herein relate to a method, further including pulling the distal tubular portion out of the hemostatic valve via a handle portion attached to the distal tubular portion.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The following figures are included to illustrate certain example aspects of the present disclosure and should not be viewed as exclusive or limiting. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. The present disclosure references the drawings as follows:

[0026] Fig. 1 illustrates a side view of a loading tool for loading a drug coated balloon through a hemostasis valve according to some examples.

[0027] Fig. 2 illustrates a side view of a portion of the loading tool of Fig. 1 according to some examples.

[0028] Fig. 3 illustrates a perspective view of the loading tool of Fig. 1 according to some examples. [0029] Fig. 4 illustrates a magnified view of a distal flared portion of the loading tool in area 4 in Fig. 2 according to some examples.

[0030] Fig. 5 illustrates a magnified view of a proximal flared portion of the loading tool in area 5 in Fig. 2 according to some examples.

[0031] Fig. 6 illustrates a cross sectional view of the loading tool taken along lines 6-6 of Fig. 2 according to some examples.

[0032] Fig. 7 illustrates a cross sectional view of the loading tool taken along lines 7-7 of Fig. 2 according to some examples.

[0033] Fig. 8A illustrates a side view of the connecting portion of the loading tool of Fig. 1 according to some examples.

[0034] Fig. 8B illustrates a cross-sectional view of the connecting portion taken along lines 8B-8B of Fig. 8A according to some examples.

[0035] Fig. 8C illustrates a cross-sectional view of the connecting portion taken along lines 8C-8C of Fig. 8A according to some examples.

[0036] Fig. 9 illustrates a side view of an introducer with a hemostasis valve being loaded with a balloon catheter according to some examples.

[0037] Fig. 10 illustrates another side view of the introducer of Fig. 9 in which a distal portion of the balloon catheter and the loading tool has been advanced through the hemostasis valve and into the introducer according to some examples.

[0038] Fig. 11 illustrates another side view of the introducer of Fig. 9 in which the drug coated balloon and most or all of the distal tubular portion has been advanced into the hemostasis valve and the introducer according to some examples.

[0039] Fig. 12 illustrates another view of the introducer of Fig. 9 in which the drug coated balloon has completely moved past the hemostasis valve and the loading tool is being removed from the balloon catheter according to some examples. DETAILED DESCRIPTION

[0040] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0041] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used and brought together in any combination. In other words, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of this disclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0042] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings are not to scale. Unless otherwise noted, the term “about” is defined to mean plus-or-minus 5% of a stated value.

[0043] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician/clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician/clinician or handle/hub of a device).

[0044] Numerical ranges discussed in this specification should be interpreted as both inclusive numerical ranges and as covering/disclosing a plurality of numbers within the ranges. Specifically, a range should be considered to recite numbers that increment by two decimal places (hundredths) for the purposes of support in the claims (e.g., 0.01 , 0.02, 0.03, etc.). Any of these incremented numbers from a range should be understood to have significance and importance in the context of the present specification. [0045] The present specification is generally directed to a loading tool for loading a drug coated balloon catheter into an introducer or similar sheath that is connected to a vascular of a patient.

[0046] Typically, introducers or similar sheaths include a hemostasis valve on their proximal end to prevent excess blood from escaping the patient. However, these hemostasis valves may scrape or partially remove some of the drug coating from the drug coated balloon, which may be undesirable. To help prevent the removal of the drug coating, some drug coated balloon catheters include a loading tool (also referred to a loading sleeve) that is temporarily placed over the balloon as it is positioned through the hemostasis valve. Once the balloon is positioned through the hemostasis valve, the loading tool may be removed and pulled out.

[0047] However, these loading tools can be difficult to remove. For example, the loading tool and/or the physician’s gloves may be covered with saline or blood which may render the loading tool slippery and therefore difficult to pull out of the hemostasis valve.

[0048] Additionally, it is possible for a physician to forget to remove this loading tool and therefore push it too far beyond the hemostasis valve and into the introducer. This may require that the physician back the drug coated balloon catheter out proximally from the hemostasis valve, though in some instances it may be difficult to do this.

[0049] The example loading tools described in this specification may include one or more features that help address these issues.

[0050] In some examples, a loading tool comprises a distal tubular portion having a flared or conical portion. The flared or conical portion may be located at a distal end of the distal tubular portion and may increase in diameter in a proximal direction. At least the distal tubular portion may be placed around a balloon of a balloon catheter to protect it as the balloon is loaded through a hemostasis valve. The flared or conical portion may be positioned near the end of the drug coated balloon (e.g., before, after, or longitudinally aligned with the proximal end of the drug coated balloon). Hence, the flared or conical portion may help prevent a physician from distally advancing the loading tool too far into or beyond the hemostasis valve by providing a “stop” that is sized large enough to either prevent it from being advanced into the hemostasis valve or that will provide the physician with tactile resistance against further distal advancement. A slit may extend longitudinally along both the distal tubular portion and the flared or conical portion to allow the loading tool to be removed from the balloon catheter after the drug coated balloon has passed through the hemostasis valve.

[0051] In some examples, the loading tool may alternately or additionally include a handle portion that allows a physician to easily grasp the loading tool and pull it out of the hemostasis valve. In one example, the handle portion comprises a proximal tubular portion that is connected to a distal tubular portion by a connecting portion. The connecting portion may be oriented at a different angle than an axis of the distal tubular portion to help position the proximal tubular portion away from an underlying balloon catheter. Put another way, in an unconstrained position, the distal tubular portion and the proximal tubular portion are offset from each other, and the connecting portion is angled to accommodate these offset positions. In some examples, the connecting portion may be an arc or part-circle cross sectional shape. In some examples, a distal end of the connecting portion may connect to a distal flared portion of the distal tubular portion and/or a proximal end of the connecting portion may connect to a proximal flared portion of the proximal tubular portion. In use, the proximal tubular portion is positioned over a balloon of the balloon catheter and then both are advanced into a hemostasis valve. Next, the user pulls on the proximal tubular portion of the handle portion to pull the distal tubular portion out of the hemostasis valve.

[0052] Fig. 1 illustrates a side view of a loading tool 100 according to some examples that may be disposed on a balloon catheter 16 that is adjacent to an introducer 10. A distal tubular portion 102 of the loading tool 100 may be positioned over a drug coated balloon 18 located on a distal end of a balloon catheter 16, protecting the drug coated balloon 18 as it is inserted into a hemostasis valve 12 of the introducer 10. Once the drug coated balloon 18 has been positioned entirely or almost entirely through the hemostasis valve 12, a physician may proximally pull on the proximal tubular portion 104 to remove the distal tubular portion 102 of the loading tool 100 from the hemostasis valve 12 and the drug coated balloon 18.

[0053] Fig. 2 illustrates a side view of a portion of the loading tool 100 according to some examples. Fig. 3 illustrates a perspective view of the loading tool 100 according to some examples. Fig. 4 illustrates a magnified view of area 4 in Fig. 2. Fig. 5 illustrates a magnified view of area 5 in Fig. 2. Fig. 6 illustrates a cross sectional view along lines 6-6 of Fig. 2. Fig. 7 illustrates a cross sectional view along lines 7-7 of Fig. 2. Fig. 8A illustrates a side view of the connecting portion 106 in Fig. 2. Fig. 8B illustrates a cross- sectional view of the connecting portion 106 taken along lines 8B-8B in Fig. 8A. Fig. 8C illustrates a cross-sectional view of the connecting portion 106 taken along lines 8C-8C in Fig. 8A. These figures will all be discussed concurrently below.

[0054] In some examples, the loading tool 100 comprises a distal tubular portion 102 for placing over a deflated drug coated balloon 18 of a balloon catheter 16. The distal tubular portion 102 may have a generally tube shape with an internal diameter sized to be about the same diameter or slightly larger than the portion of the balloon catheter 16 with the drug coated balloon 18. The distal tubular portion 102 may also have a length of about the same size as the drug coated balloon 18 (e.g. , larger, smaller, or the same size as the drug coated balloon 18). Since the length and deflated diameter of a drug coated balloon 18 may vary, the inner diameter and length of the distal tubular portion 102 may similarly vary.

[0055] As seen best in Fig. 4, a distal flared portion 108 may be included at a proximal end of the distal tubular portion 102. The distal flared portion 108 may have a flared or conical shape that increases in diameter in a proximal direction. The distal flared portion 108 may increase in diameter from its smallest diameter to its largest diameter by a percent in an inclusive range of about 5 to 30% or about 0.2 to 5 mm.

[0056] While the distal flared portion 108 is illustrated as having a linearly increasing diameter, other shapes are also possible. For example, the distal flared portion 108 may have a non-linearly increasing diameter (e.g., exponentially increasing), such that it curves similar to a trumpet/horn shape. In another example, the distal flared portion 108 may increase in diameter and then decrease in diameter to create a circumferential ridge or bump.

[0057] The distal flared portion 108 may be helpful, in some examples, for creating a region of larger diameter of the loading tool 100 which may either prevent the distal flared portion 108 from passing through the hemostasis valve 12 and/or may create resistance to distal advancement to create tactile feedback for the physician. Hence, a physician may be reminded to remove the loading tool 100 at the appropriate time instead of accidentally further pushing the loading tool 100 too far into the introducer 10.

[0058] Both the distal tubular portion 102 and the distal flared portion 108 may include a slit 102A extending longitudinally along their lengths, as best seen in the cross sectional view of Fig. 6 taken along lines 6-6 in Fig. 2. Once the distal tubular portion 102 is pulled out from the hemostasis valve 12, the slit 102A allows the user to pull the distal tubular portion 102 and distal flared portion 108 off of the balloon catheter 16 so that the balloon catheter 16 may be further advanced distally within the patient without the loading tool 100 further hindering the procedure. Alternatively, the slit 102A along the distal tubular portion 102 and the distal flared portion 108 may be an arrangement that allows the structures to be torn open, such as a perforated line or a plurality of small slits/punctures. Hence, the distal tubular portion 102 and the distal flared portion 108 may be torn open and similarly removed from the balloon catheter 16.

[0059] In some examples best seen in Fig. 2, a proximal tubular portion 104 may be attached to the distal tubular portion 102 via a connecting portion 106 to act as a handle portion for pulling the distal tubular portion 102 out of the hemostasis valve 12. While the proximal tubular portion 104 is illustrated as having a similar diameter to the distal tubular portion 102, it may also have a larger or smaller diameter than the distal tubular portion 102. As seen in the cross sectional view of Fig. 7 taken along lines 7-7 in Fig. 2, the proximal tubular portion 104 may be a cross-sectionally open tubular structure with a slit or gap 104A along the length of its wall like the distal tubular portion 102. In other examples, the proximal tubular portion 104 may have a cross-sectionally closed tubular structure without a slit or gap 104A along the length of its wall. In other examples, the proximal tubular portion 104 may be solid instead of hollow. In other examples, the proximal tubular portion 104 may have a non-circular cross-sectional shape, such as a square, rectangle, hexagonal, or similar cross-sectional shape. In some examples, the proximal tubular portion 104 may include cavities, voids, extrusions, ribs, irregular texture, or similar features on an outer surface of the proximal tubular portion 104 to improve traction and to reduce slippage when pulling the proximal tubular portion 104 is grasp and pulled.

[0060] In some examples, the proximal tubular portion 104 may be connected to the distal tubular portion 102 via a connecting portion 106. In the example of Figs. 1 -8C, the connecting portion 106 may have a cross-sectional shape of a part circle. In other words, the connecting portion 106 may have an elongated curved shape with a longitudinal groove extending along its length, as seen in Fig. 3 (e.g., an open tubular shape).

[0061] Aspects of the longitudinal groove according to some examples may be further seen in Fig. 8A which illustrates a side view of the connecting portion 106, seen in Fig. 8B which illustrates a cross-sectional view of the connecting portion 106 taken along lines 8B-8B in Fig. 8A, and seen in Fig. 8C which illustrates a cross-sectional view of the connecting portion 106 taken along lines 8C-8C in Fig. 8A. The longitudinal groove or open tubular shape of the connecting portion 106 may decrease in how far around it curves along the proximal direction, which can be seen by comparing cross-sectional area 106A of the connecting portion 106 in Fig. 8B to the cross-sectional portion 106B of the connecting portion 106 in Fig. 8C (both of which are denoted with cross hatching). In one example, the cross-section area 106A curves around about 180 degrees while the cross- sectional area 106B curves around about 150 degrees, though other variations are also possible. Alternatively, the longitudinal groove shape of the connecting portion 106 may increase in its curvature in a proximal direction.

[0062] In other alternative examples, the connecting portion 106 may be an elongated solid member, a closed tubular portion, or similar structures. [0063] In the example of Figs. 1-8C, the connecting portion 106 may be connected to a proximal end of the distal flared portion 108. In other examples, the connecting portion 106 may be directly connected to the distal tubular portion 102 (e.g., if no distal flared portion 108 is present).

[0064] In the example of Figs. 1-8C, the connecting portion 106 may be connected to a proximal flared portion 110 located at the distal end of the proximal tubular portion 104, as best seen in Fig. 5. Alternatively, the connecting portion 106 may be directly connected to the proximal tubular portion 104.

[0065] The proximal flared portion 110 may have a flared or conical shape that increases in diameter in a distal direction. The proximal flared portion 110 may increase in diameter from its smallest diameter to its largest diameter by a percent in an inclusive range of about 5 to 30% or about 0.2 to 5 mm.

[0066] While the proximal flared portion 110 is illustrated as having a linearly increasing diameter, other shapes are also possible. For example, the proximal flared portion 110 may have a non-linearly increasing diameter (e.g., exponentially increasing), such that it curves similar to a trumpet/horn shape. In another example, the proximal flared portion 110 may increase in diameter and then decrease in diameter to create a circumferential ridge or bump.

[0067] If the distal flared portion 108 is pushed distally past the hemostasis valve 12 during a procedure, the proximal flared portion 110 may also provide either tactile resistance to further distal movement as it presses against the hemostasis valve 12 or may provide a “stop” that prevents the loading tool 100 from further advancement into the hemostasis valve 12.

[0068] As best seen in Fig. 2, the connecting portion 106 is connected to position the proximal tubular portion 104 out of alignment or laterally away from the distal tubular portion 102. Since the proximal tubular portion 104 is used as a handle portion, positioning it out of alignment or laterally away from the distal tubular portion 102 helps keep the proximal tubular portion 104 away from the body of the balloon catheter 16, as seen in Fig. 1.

[0069] In some examples, the distal tubular portion 102 has a longitudinal axis 102B extending therethrough and the connecting portion 106 forms an angle 102C with the distal tubular portion 102 or longitudinal axis 102B. In the example of Fig. 2, the proximal tubular portion 104 is positioned generally parallel to the distal tubular portion 102. In other words, a longitudinal axis 104A of the proximal tubular portion 104 is generally parallel to the longitudinal axis 102B when the loading tool 100 is unconstrained. In some examples, the longitudinal axis 104A and the longitudinal axis 102B are vertically or laterally offset from each other by an inclusive range of about 1 mm to about 5 mm, or more specific inclusive values of 1 , 1.1 , 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8, 1.9, or 2 mm. In other examples, the proximal tubular portion 104 may form a non-parallel angle with the distal tubular portion 102, such as maintaining the angle 102C of the connecting portion 106.

[0070] In some examples, the distal tubular portion 102 has a length within an inclusive range of about 105 mm to about 235 mm. In some examples, the proximal tubular portion 104 has a length within an inclusive range of about 10 to 20 mm (e.g., 15 mm). In some examples, the connecting portion 106 has a length within an inclusive range of about 5 to 15 mm (e.g., 10 mm). In some examples, the slit 102A has a width within an inclusive range of about 0.001 to about 0.003 inch (e.g., 0.003 inch). In some examples, the distal tubular portion 102 has an internal diameter within an inclusive range of about 1 .4 to 1 .85 mm. In some examples, the proximal tubular portion 104 has an external diameter within an inclusive range of about 1.7 to 2.15 mm. In some examples, the distal flared portion 108 has an internal diameter at its largest proximal end within an inclusive range of about 1 .8 to 2.25 mm.

[0071] All of the portions of the loading tool 100 may be integrally formed with each other (e.g., via an injection molding process) or the portions may be formed and then fixed to each other (e.g., adhesive or melting). The portions of the loading tool 100 may be composed of a flexible material such as silicone or a polymer (e.g., polyvinyl chloride, polyethylene (e.g., HDPE), or polypropylene).

[0072] Figs. 9-12 illustrate one example technique of using the loading tool 100, though other variations are also possible. Fig. 9 illustrates a side view of an introducer 10 with a hemostasis valve 12. A distal portion of the introducer 10 may be placed into the vascular system of the patient and a guidewire 14 may be placed through the hemostasis valve 12, into the introducer 10, and into the vascular system until a distal portion of the guidewire 14 is located near a target area of the vascular system.

[0073] The balloon catheter 16 may have an elongated body and a drug coated balloon 18 at a distal portion of its elongated body. The balloon catheter 16 may be first placed over the guidewire 14. In some examples, the balloon catheter 16 may be an over-the-wire catheter in which the guidewire passage extends an entire length of elongated body of the balloon catheter 16. In other examples, the balloon catheter 16 may be a rapid-exchange catheter in which the guidewire lumen extends only a short distance along a distal portion of the balloon catheter 16, terminating with a proximal guidewire port just proximal of the drug coated balloon 18. Once the balloon catheter 16 is loaded onto the guidewire 14, the balloon catheter 16 is distally advanced near the hemostasis valve 12, as seen in Fig. 9.

[0074] Fig. 10 illustrates another side view of the introducer 10 in which a distal portion of the balloon catheter 16 and the loading tool 100 has been advanced through the hemostasis valve 12 and into the introducer 10.

[0075] Fig. 11 illustrates another side view of the introducer 10 in which the drug coated balloon 18 and most or all of the distal tubular portion 102 has been advanced into the hemostasis valve 12 and the introducer 10. As the end of the distal tubular portion 102 reaches the hemostasis valve 12, the distal flared portion 108 begins to move against the hemostasis valve 12. This may cause tactile resistance to further distal movement and, depending on the force used on the balloon catheter 16, may provide a “stop” that prevents any further distal movement of the loading tool 100. [0076] Fig. 12 illustrates another view of the introducer 10 in which the drug coated balloon 18 has completely moved past the hemostasis valve 12. At this time, the physician may use the proximal tubular portion 104 as a handle portion to proximally pull the distal tubular portion 102 of the loading tool 100 out of the hemostasis valve 12, as indicated by the arrow in Fig. 12. Subsequently or simultaneously, the physician may laterally pull the distal tubular portion 102 off of the balloon catheter 16, allowing the elongated body portion of the balloon catheter 16 to pass through the slit 102A of the distal tubular portion 102.

Claims

What is claimed is:

1 . A loading tool for a drug coated balloon catheter, comprising: a distal tubular portion; a distal flared portion located at a proximal end of the distal tubular portion; the distal flared portion increasing in diameter in a proximal direction; and, a handle portion connected to the distal flared portion.

2. The loading tool of claim 1 , wherein the handle portion comprises a proximal tubular portion and a connecting portion that is connected to the distal flared portion and to the proximal tubular portion.

3. The loading tool of claim 1 , wherein the handle portion comprises a proximal tubular portion, a proximal flared portion located at a distal end of the proximal tubular portion, and a connecting portion that is connected to the distal flared portion and to the proximal flared portion.

4. The loading tool of claim 1 , wherein the handle portion comprises a proximal tubular portion and a connecting portion that is connected to the distal flared portion and to the proximal tubular portion.

5. The loading tool of claim 4, wherein the connecting portion comprises an open tubular shape.

6. The loading tool of claim 4, wherein the connecting portion is angled laterally away from a longitudinal axis of the distal tubular portion.

7. The loading tool of claim 6, wherein a longitudinal axis of the proximal tubular portion is parallel to the longitudinal axis of the distal tubular portion.

8. The loading tool of claim 1 , further comprising a slit extending longitudinally through the distal tubular portion and the distal flared portion.

9. A loading tool for a drug coated balloon catheter, comprising: a distal tubular portion having a first longitudinal axis extending therethrough; a proximal tubular portion having a second longitudinal axis extending therethrough; and, a connecting portion connected to a proximal end of the distal tubular portion and a distal end of the proximal tubular portion; wherein the first longitudinal axis is offset and parallel to the second tubular portion and wherein the connecting portion forms an angle laterally away from the first tubular portion.

10. The loading tool of claim 9, wherein the distal tubular portion further comprises a distal flared portion located at the proximal end of the distal tubular portion.

11 . The loading tool of claim 10, wherein the proximal tubular portion further comprises a proximal flared portion located at the distal end of the proximal tubular portion.

12. The loading tool of claim 11 , further comprising a slit extending longitudinally along the distal tubular portion and the distal flared portion.

13. The loading tool of claim 12, wherein the proximal tubular portion is a closed tube.

14. The loading tool of claim 13, wherein the connecting portion is an open tubular shape.

15. The loading tool of claim 14, wherein the connecting portion is an elongated curved shape with a longitudinal groove extending along a length of the connecting portion.

16. A loading tool for a drug coated balloon catheter, comprising: a distal tubular portion having a first longitudinal axis extending therethrough; a proximal tubular portion having a second longitudinal axis extending therethrough; and, a connecting portion connected to a proximal end of the distal tubular portion and a distal end of the proximal tubular portion; wherein the connecting portion is an elongated curved shape with a longitudinal groove extending along a length of the connecting portion.

17. The loading tool of claim 16, further comprising a longitudinal slit extending along a length of the distal tubular portion.

18. The loading tool of claim 17, wherein the proximal tubular portion is a closed tubular structure.

19. The loading tool of claim 18, further comprising a distal flared portion at a proximal end of the distal tubular portion and a proximal flared portion at a distal end of the proximal tubular portion.

20. A loading tool for a drug coated balloon catheter, comprising: a distal tubular portion having a longitudinal slit; and, a handle means for removing the distal tubular portion from a hemostatic valve.

21 . A method of using a loading tool, comprising: placing a distal tubular portion over an uninflated drug coated balloon of a balloon catheter; advancing the distal tubular portion and uninflated drug coated balloon into a hemostatic valve; creating a resistance to distal movement of the distal tubular portion and the uninflated drug coated balloon with a flared portion connected at a proximal end of the distal tubular portion.

22. The method of claim 21 , further comprising pulling the distal tubular portion out of the hemostatic valve via a handle portion attached to the distal tubular portion.