Scored balloon with translating score lines

Abstract

The present application discloses a scored balloon catheter comprising: a shaft; an inflatable balloon mounted at a distal region of the shaft; an inflation lumen; a guidewire lumen arranged inside the shaft; a handle mounted at the proximal end of the shaft, the handle having a guidewire port and a balloon inflation port; a spring coaxially mounted inside the shaft at the distal end of the handle, the spring having a distal region; at least two scored line lumens, the scored line lumens being arranged close to each other on one side of the shaft inside the shaft, close to the guidewire lumen, the scored line lumens having a distal end starting proximal to the balloon and a proximal end ending distal to the spring; at least two scored lines, each scored line being within one scored line lumen, the scored line having: an end mounted on the shaft and located between the distal end of the shaft and the balloon; a middle portion; a proximal portion; and a proximal end fixed to the spring.

Description

[0001] This divisional application is a divisional application based on the Chinese patent application with application number 201680069881X (whose international application number is PCT / US2016 / 059537), application date of October 28, 2016, and invention name “Scored balloon with translational scoring lines”. Background Art

[0002] Balloon dilatation catheters are used to treat vascular lesions. However, they can be challenging to navigate through tortuous anatomy and safely pass through very tight lesions. Furthermore, some lesions are difficult to dilate using only a balloon, requiring concentrated force to dilate the lesion at a safe inflation pressure.

[0003] U.S. Patent No. 6,394,995 to Solar et al. describes a system for providing increased force to treat lesions. This system comprises a flexible propulsion member comprising a tracking member that slides over a guidewire and a balloon having a distal end attached to the tracking member. However, this type of system provides limited focused force and lacks pushability and maneuverability. Summary of the Invention

[0004] According to one aspect of the present disclosure, a scoring balloon catheter is provided. The catheter allows for translation (e.g., longitudinal) of a score line in conjunction with the expansion of the balloon due to inflation. This advantageously allows the line to be moved to the correct position for scoring a lesion, but retracted when not desired for this purpose (e.g., when the balloon is uninflated and tracking to the treatment site). Furthermore, it allows the score line to be extended by the correct amount based on the level of balloon inflation. In a specific embodiment, the present invention provides a scoring balloon catheter that can be used to treat vascular lesions. In use, the balloon presses the score line into the lesion. The catheter comprises: a shaft; an inflatable balloon mounted on a distal portion of the shaft; a component or spring connected to the shaft proximally of the balloon; and at least one score line. In some embodiments, the score line has a fixed end mounted on the shaft between the distal end of the shaft and the balloon. The score line has a longitudinally movable end connected to the component or spring and a middle portion disposed externally of the balloon.

[0005] In some embodiments, the movable scored line ends are proximal ends of the lines. These ends extend into the lumen of the component. In some embodiments, the component includes or interacts with a longitudinal elastic component such as an elastic polymer or rubber or a spring. In some embodiments, the device further includes a second component, and the spring is located between the component and the second component.

[0006] In some embodiments, the device comprises a scored lumen inside or outside the shaft. The scored lumen contains one or more score lines. In some embodiments, the device comprises two lumens inside the shaft and two score lines inside the lumens.

[0007] In other embodiments, the scored balloon catheter utilizes a biasing member, such as a spring mounted within the hub of the handle assembly. A shaft passes through the spring and extends into the handle assembly. A hub cover is disposed over the shaft and the hub. In some instances, the hub cover relieves stress from the hub-spring connection. The scored line is welded or otherwise attached to the spring. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The above and other advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0009] Figure 1a is a front view of an example of the device of the present invention.

[0010] Figure 1b yes Figure 1a Magnified view of the indicated portion.

[0011] Figure 1c yes Figure 1a Magnified view of the indicated portion.

[0012] Figure 2a It is a front view of another example of the device of the present invention.

[0013] Figure 2b yes Figure 2a Magnified view of the indicated portion.

[0014] Figure 2c yes Figure 2a Magnified view of the indicated portion.

[0015] Figure 3a It is a front view of another example of the device of the present invention.

[0016] Figure 3b yes Figure 3a Magnified view of the indicated portion.

[0017] Figure 3c yes Figure 3a Magnified view of the indicated portion.

[0018] Figure 4a It is a front view of another example of the device of the present invention.

[0019] Figure 4b yes Figure 4a Magnified view of the indicated portion.

[0020] Figure 4c yes Figure 4a Magnified view of the indicated portion.

[0021] Figure 5a It is a front view of another example of the device of the present invention.

[0022] Figure 5b yes Figure 5a Magnified view of the indicated portion.

[0023] Figure 5c yes Figure 5a Magnified view of the indicated portion.

[0024] Figure 6 It is a front view of another embodiment of the device of the present invention.

[0025] Figure 7a 1 is an end view taken along the line BB.

[0026] Figure 7b Similar to Figure 7a , showing the cross section AA in different embodiments of the present invention.

[0027] Figure 8a is a cross-sectional view showing an embodiment of the device along a cross-section similar to section AA.

[0028] Figure 8b Similar to Figure 8a , showing the cross section AA in different embodiments of the present invention.

[0029] Figure 9 yes Figure 6 Cross-sectional view of the device.

[0030] The drawings are not necessarily drawn to scale or proportion. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity, or multiple physical components may be included in a single functional block or element. Furthermore, reference numerals may sometimes be repeated in the drawings to indicate corresponding or similar elements. Furthermore, some blocks shown in the drawings may be combined into a single function. DETAILED DESCRIPTION

[0031] In the detailed description below, many specific details are set forth in order to provide a thorough understanding of the present invention. It should be understood by those skilled in the art that the present invention may be practiced without these specific details. In other cases, well-known methods, processes, components or structures may not be described in detail to avoid obscuring the present invention.

[0032] The present invention relates to a system and method for treating blood vessels. The principles and operation of the system and method of the present invention may be better understood with reference to the accompanying drawings and accompanying descriptions.

[0033] The invention is not limited in its application to the details of construction and arrangement of parts described in the following description or illustrated in the accompanying drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Furthermore, it should be understood that the phraseology and terminology used herein are for illustrative purposes only and should not be construed as limiting.

[0034] Certain features of the invention which are, for clarity, described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for clarity, described in the context of a single embodiment may also be provided separately or in any suitable subcombination.

[0035] Parts List

[0036]

[0037]

[0038]

[0039] definition

[0040] "Fixed" - cannot be separated within the operating environment of the device.

[0041] "Operating Environment" - any environment in which the device may conceivably operate as an intravascular balloon catheter.

[0042] "Longitudinal elasticity" - the ability to move repeatedly in the longitudinal direction.

[0043] "Definition of Mechanical Connectivity" - describes the ability of one object to be sufficiently connected so that its movement causes the movement of another object, and vice versa.

[0044] "Guide" - a generally longitudinal object that supports and guides the movement of another object.

[0045] A "slidably engaged" component is one that fits into a channel or around a guide rail so that the component is generally or substantially constrained in two dimensions. Rather than being a three-dimensionally constrained component, the component is somewhat unconstrained, thereby allowing the component to move longitudinally within the channel or along the guide rail for a considerable distance. A component is considered slidably engaged when the system has stops or other components that limit longitudinal movement while still allowing for significant longitudinal movement.

[0046] "Effectively engage" - a score line effectively engages a lesion when it engages the lesion well enough (for treatment) to significantly affect the lesion.

[0047] The catheter of the present invention can be an over the wire, a shorter rapid exchange or a rapid exchange platform. When the catheter is a shorter rapid exchange platform, the inner component can traverse the entire length of the catheter.

[0048] Turning to the embodiments of the present invention, Figure 1a Embodiments of the present invention are described. In an embodiment of the present invention, a scored balloon (SCB) catheter 100 is shown in elevation with selected portions shown in enlarged view. The SCB catheter 100 includes the following components. For example, the catheter 100 includes a shaft 105. The shaft 105 has a proximal shaft portion 106 connected to a mid-shaft portion 107 and a mid-shaft portion 107 connected to a distal shaft portion 108. A shaft tapered portion 111 connects the proximal shaft portion 106 to the mid-shaft portion 107. The shaft 105 also includes a shaft wall 109 that provides a degree of rigidity to the shaft 105 so that the shaft 105 is suitable (as determined by one of ordinary skill in the art) for tracking into vasculature that is neither too rigid nor too flexible or into tortuous vasculature. In some embodiments, the rigidity or flexibility is altered by adding longitudinal components (not shown) to the SCB catheter 100. In some embodiments, the shaft 105 includes Pebax.

[0049] In some embodiments, the shaft tapered portion 111 is secured to the shaft mid-portion 107. In some embodiments, the shaft wall 109 ends before the shaft distal end 110 ends.

[0050] For purposes herein, the shaft distal end 110 is the end of the shaft 105 that first enters the patient's body. Similarly, any other "distal" feature means the portion of the component that is closer to the shaft distal end 110 than any other component portion. Similarly, any "proximal" feature means the portion of the component that is farther from the shaft distal end 110 than any other component portion.

[0051] SCB catheter 100 also includes an inflatable balloon (IB) 115. Inflatable balloon 115 is mounted on shaft 105 and within shaft distal portion 108. In some embodiments, inflatable balloon 115 terminates at shaft distal end 110. In these or other embodiments, inflatable balloon 115 is fixed to shaft 105.

[0052] Inflatable balloon 115 includes a 1B proximal end 130 and a 1B distal end 131. Typical embodiments utilize a flexible polymer film as inflatable balloon 115. After inflatable balloon 115 is mounted on shaft 105, 1B outer surface 132 terminates facing the lumen. For purposes of the present invention, 1B proximal end 130 is the portion of inflatable balloon 115 that attaches or secures the proximal end of inflatable balloon 115 to shaft 105. 1B proximal end 130 is defined as the proximal portion of inflatable balloon 115 that remains in contact with shaft 105 after inflating.

[0053] For the present invention, IB distal end 131 is the portion of inflatable balloon 115 that distally attaches or secures inflatable balloon 115 to shaft 105. IB distal end 131 is defined as the distal portion of inflatable balloon 115 that remains in contact with shaft 105 after inflatable balloon 115 is inflated.

[0054] The IB lumen 133 is in fluid communication with the inflatable balloon 115 , which enables the inflatable balloon 115 to be inflated by fluid passing through the IB lumen 133 .

[0055] The SCB catheter 100 also includes a guidewire lumen (GWL) 119 that extends longitudinally from at least the shaft proximal end 112 to beyond the shaft distal end 110. The GW lumen 119 terminates at a GWL distal end 120.

[0056] In some embodiments, the IB proximal end 130 and the IB distal end 131 are coupled to the GWL outer surface 121 or the shaft 105 using any method known to one of ordinary skill in the art.

[0057] The SCB catheter 100 also includes a score wire (SCW) 135. The score wire 135 includes a fixed SCW end 136, an SCW IB portion 137, and a movable SCW end 138. The fixed SCW end 136 is connected within the shaft distal portion 108 distal to the IB distal end 131. In some embodiments, the fixed SCW end 136 is attached to the GWL outer surface 121. In other embodiments, the fixed SCW end 136 is attached to the outside of the shaft wall 109. The fixed SCW end 136 is attached using any method known to those of ordinary skill in the art.

[0058] This structure provides a force concentrating element (score line 135 ) next to the inflatable balloon 115 .

[0059] The distance between the score line 135 and the IB outer surface 132 can be any value deemed advantageous by one of ordinary skill in the art. Once past the inflatable balloon 115, the score line 135 submerges beneath the shaft wall 109, thereby extending proximally within the interior of the shaft 105. The movable SCW end 138 is disposed within the interior of the shaft 105 within the proximal portion 106 of the shaft. In some embodiments, the score line 135 occupies at least a portion of the SCW lumen 1139 (e.g., Figure 8a and 8b ).

[0060] Figure 1a-Figure 5bThe SCB catheter 100 is shown having two score lines. In some embodiments, the SCB catheter 100 has 1-15, 3-10, or 2-5 score lines. In some embodiments, the diameter of the SCW 135 is between 0.003 inches and 0.040 inches, or between 0.005 inches and 0.015 inches, or between 0.008 inches and 0.012 inches. In some embodiments, the SCW 135 is 0.10 inches. The SCW 135 need not have a uniform diameter. In some embodiments, the diameter of the SCW distal portion 1351 is greater than the diameter of the SCW proximal portion 1352. In some embodiments, the diameter of the SCW distal portion 1351 is less than the diameter of the SCW proximal portion 1352. In some embodiments, the SCW 135 comprises a metal, a metal alloy, a polymer, or a metal- or polymer-based shape memory material.

[0061] The SCB catheter 100 also includes a hub 140. The hub 140 is located inside the shaft 105 and within the proximal shaft portion 106. The hub 140 includes a GWL channel 141 for the guidewire lumen 119 to pass through. The hub 140 also includes one or more hub lumens 145 that interact with the movable SCW end 138.

[0062] In some embodiments, the interaction comprises the movable SCW end 138 being connected to or onto the hub lumen 145. In some embodiments, the movable SCW end 138 is fixed to the hub lumen 145. In other embodiments, the interaction comprises the movable SCW end 138 slidingly engaging the interior of the hub lumen 145. In some embodiments, the hub 140 comprises any biocompatible material, such as metals, metal alloys, and polymers. In some embodiments, the hub 140 comprises nylon, Pebax, or any other suitable material known to those of ordinary skill in the art.

[0063] In some embodiments, the hub 140 is substantially fixed within the proximal shaft portion 106, with the movable SCW end 138 slidingly engaged or disposed within the hub lumen 145. In some embodiments, the hub 140 is longitudinally movable or resilient, such that the movable SCW end 138 can be longitudinally moved by pulling the hub 140 distally, by moving the hub 140, or by stretching the material of the hub 140. For example, in some embodiments, the hub 140 is resilient. When the movable SCW end 138 is subjected to a distally directed force that moves it distally and when the movable SCW end 138 is fixed to or within the hub lumen 145, this movement stretches the hub 140. A restoring force, or a force opposing the distal stretch (a reaction force), causes the movable SCW end 138 to return substantially to its original position when the distally directed force is removed.

[0064] In some embodiments, the hub 140 is biased by a spring 200. In some embodiments, the spring 200 is mounted distally of the hub 140, and in some embodiments, the spring 200 is mounted proximally of the hub 140.

[0065] The SCW catheter 100 also includes a handle assembly 150. The handle assembly 150 is connected to the proximal end 109 of the shaft. The handle assembly 150 includes an HA port subassembly and an HA transition subassembly. The HA port subassembly occupies at least a portion of the proximal end of the handle assembly 150. And the HA transition subassembly occupies at least a portion of the distal end of the handle assembly 150. The HA port subassembly is associated with the HA transition subassembly. In some embodiments, the HA port subassembly is connected to or fixed to the HA transition subassembly. In some embodiments, the HA port subassembly and the HA transition subassembly together form a single object or multiple objects, or form a single object separated by a plane containing the longitudinal axis of the SCW catheter 100.

[0066] The HA transition subassembly includes a HA step-down portion 156 disposed at the distal end of the HA transition subassembly. In some embodiments, the distal end of the HA transition subassembly and the distal end of the handle assembly 150 are the same object.

[0067] The HA step-down portion 156 is a portion of the HA transition subassembly where the overall outer dimension has a stepped transition to a smaller diameter that is sized to engage the proximal shaft end 112 .

[0068] In some embodiments, the transition subassembly 152 lacks the HA step-down portion 156 .

[0069] The shaft 105 is associated with the handle assembly 150 via the shaft proximal end 112 and the HA step-down portion 156. In some embodiments, the shaft 105 is connected to the handle assembly 150. For example, the shaft proximal end 112 can be slid through the HA step-down portion 156, and the components can be fixed, such as by welding, fusing, gluing, etc. Alternatively, the friction fit between the shaft proximal end 112 and the HA transition subassembly can be strong enough to secure the components together. In some embodiments without the HA step-down portion 156, the shaft proximal end 112 can be connected to the handle assembly 150 via a butt joint between the shaft proximal end 112 and the HA transition subassembly 152.

[0070] The HA port subassembly includes a HA GW port 154 that occupies the proximal end of the HA port subassembly. In some forms of the handle assembly 150, the HA GW port 154 points away from the distal end 110 of the shaft. The HA GW port 154 allows access to the guidewire lumen 119 from the outside of the SCB catheter 100. In some forms of the handle assembly 150, the HA port subassembly also includes a HA 1B lumen port 153 that extends obliquely from the longitudinal axis of the SCB catheter 100 at any angle deemed advantageous by one of ordinary skill in the art. In some forms, the HA 1B lumen port 153 flows into the guidewire port guidewire lumen area, and in other embodiments, flows into a separate lumen inside or outside the guidewire lumen 119 (not shown). The HA 1B lumen port 153 also allows access to a channel (the guidewire lumen 119 or the IB lumen 133 (IBL)) from outside the SCB catheter 100 that delivers gas or inflation fluid to the inflatable balloon 115 to inflate it or to deliver gas or inflation fluid from the inflatable balloon 115 to deflate it.

[0071] Operationally, Figure 1a In the device described in the embodiments, for example, to treat a calcified lesion, a physician cuts open the patient's tissue until a suitably sized blood vessel is exposed. The blood vessel must follow a pathway leading to the lesion, and the SCB catheter 100 can be moved along this pathway. In some embodiments, the location of the lesion dictates that one skilled in the art select a more or less flexible shaft 105 or SCB catheter 100.

[0072] The physician opens the vessel, inserts a guidewire into the vessel, and advances the guidewire through the patient's vasculature under ultrasound, magnetic resonance imaging, fluoroscopy, or some other type of guidance. Once the physician has positioned the guidewire in a desired location, the physician directs the proximal end of the guidewire into the distal GWL end 120, through the guidewire lumen 119, and ultimately out of the SCB catheter 100 through the HA GW port 154. With the guidewire in place and installed in the SCB catheter 100, the physician maneuvers the SCB catheter 100 along the guidewire until the inflatable balloon 115 reaches a desired position near the lesion. Typically, this position will allow at least one score line 135 to effectively engage the lesion. The physician then inflates the inflatable balloon 115 until the score line 135 is firmly pressed into the lesion or ruptures the lesion. Once lesion treatment via the SCB catheter 100 is complete, the physician deflates the inflatable balloon 115, which relaxes the score line 135 away from the lesion and the vessel wall.

[0073] As long as inflatable balloon 115 remains inflated, score line 135 contacts the lesion. The inflation time corresponds to the time selected by the physician to keep score line 135 in contact with the lesion. Those skilled in the art use inflation times ranging from 5 seconds to 5 minutes. Those skilled in the art will determine the appropriate inflation time and rate based on the nature of the lesion.

[0074] One aspect of the present invention includes the performance of the score line 135, and in particular, the performance of the movable SCW end 138, during balloon inflation.

[0075] When the inflatable balloon 115 is inflated, the score line(s) 135 expand outward, thereby placing the score line 135 in longitudinal tension. The components of the force vector caused by this longitudinal tension are directed proximally from the fixed SCW end 136 and distally from the movable SCW end 138. However, the fixed SCW end 136 is fixed to the shaft 105 or the GWL outer surface 121. Therefore, any movement of the score line 135 will occur at the movable SCW end 138. The hub 140 limits the movement of the movable SCW end 138, thereby allowing it to move longitudinally. This movement reduces the strain on the inflatable balloon 115, thereby helping to maintain its engineered shape and helping to avoid any kinking in the balloon mesh, which is sometimes seen in prior art devices that have score lines that are essentially fixed at both ends.

[0076] When the physician deflates the balloon, the force that previously expanded the score line 135 disappears, allowing the score line 135 (and the movable SCW end 138) to relax. The hub 140 limits the relaxation of the movable SCW end 138. Specifically, the hub 140 guides the movable SCW end 138 into an arrangement similar to the initial arrangement of the movable SCW end 138 before balloon inflation. The effect of the hub 140 helps regulate the inflation and deflation steps, thereby increasing their predictability.

[0077] Back to Figure 1a , Figure 1a The catheter is described above. The special shaft 105 can be manufactured by a variety of methods known to those skilled in the art. Figure 1a The embodiment shown in the figures includes a shaft 105 connected (attached, connected, combined) to a handle assembly 150 via a HA distal portion 155 and a HA step-down portion 156. The HA step-down portion 156 occupies the shaft lumen 113 and substantially seals the shaft proximal end 112 from the atmosphere. In some embodiments, the shaft proximal end 112 and the HA distal portion 155 are bonded together by an adhesive. In other embodiments, no adhesive is used. Other methods of connection are known to those of ordinary skill in the art. These are considered to be within the scope of the present invention.

[0078] exist Figure 1a 14. In the embodiment shown in FIG. 14, the HA stepped-down portion 156 is located midway along the length of the HA distal portion 155. Furthermore, in this embodiment, the HA distal portion 155 also serves as the hub 140. Reference numerals denote the same component because the component serves as both the HA distal portion 155 and the hub 140.

[0079] Figure 1b is an enlarged view of the shaft proximal portion 106. The shaft 105 terminates at the shaft proximal end 112 and receives a hub 140 which may or may not be part of the HA distal end 155. The hub 140 can have one or more hub lumens 145 - Figure 1b Two hub lumens 145 are shown. In this embodiment, these hub lumens 145 extend longitudinally into the hub 140. However, the SCB catheter 100 does not require longitudinal hub lumens 145 to function properly. The hub lumens 145 are only required to slidably and reversibly receive the movable SCW tip 138. Figure 1b The hub lumen 145 is shown extending into the hub 140 approximately three-quarters of the way through the hub 140, but this is not critical. In some embodiments, the hub lumen 145 extends completely through the hub 140. The hub lumen 145 extends into the hub 140 as far as, or further than, the movable SCW tip 138 extends into the hub lumen 145. Figure 1bAlso shown are the score lines 135 and the movable SCW tip 138. In this embodiment, the score lines 135 taper or flare outward after proximally exiting the SCW lumen 1139. The movable SCW tip 138 occupies a portion of the hub lumen 145. In this embodiment, the SCB catheter 100 includes one hub lumen 145 for each movable SCW tip 138. However, other embodiments exist in which the hub lumen can interact with more than one movable SCW tip 138.

[0080] at last, Figure 1b The guidewire lumen 119 is shown passing through the hub 140 and continuing into the shaft 105 . Figure 1c An enlarged view of the area where the score line 135 exits the SCW lumen 1139 distally is depicted.

[0081] The score line 135 has a passageway through a portion of the SCB catheter 100. The SCW lumen 1139 is a lumen that receives the score line 135 along some or all of the mid-shaft portion 107. We will refer to the portion of the score line 135 within the SCW lumen 1139 as the SCW lumen portion 1361. We will refer to the portion of the score line 135 near the inflation balloon 115 as the SCW IB portion 137.

[0082] For purposes of this description, we begin the pathway at the movable SCW end 138. The movable SCW end 138 is located within the hub lumen 145. As we move distally along the score line 135, we reach the proximal end of the SCW lumen 1139, which the score line 135 occupies. In some embodiments, the score line 135 tapers inwardly proximal to the SCW lumen 1139. The score line 135 exits the SCW lumen 1139 distally at the distal end of the lumen. We will refer to the portion of the score line 135 that begins at this exit as the SCW IB portion 137. After exiting, the score line 135 flares outward as it proceeds distally, extending in a generally longitudinal direction until the line passes the IB distal end 131. At this point, the score line 135 turns inward until it reaches the shaft distal portion 108 or the GWL outer surface 121. The fixed SCW end 136 is attached to the SCB catheter 100 distal to the inflatable balloon 115 or at or near the point where the IB distal end 131 is attached to the SCB catheter 100. The portion of the score line 135 within the SCW IB portion 137 has a longitudinal extent along the inflatable balloon 115. The distance that this longitudinal portion extends from the central axis of the SCB catheter 100 (the linear distance) can have a variety of values. The distance that the IB outer surface 132 extends from the central axis when the inflatable balloon 115 is inflated is the balloon expansion distance. Typically, (linear distance) / (balloon expansion distance) is in the following ranges: 0.99-1.01; 0.90-1.1; 0.8-1.2; and 0.5-1.5.

[0083] In by Figure 1a In operation of one set of embodiments represented by the device, a physician deploys the expandable balloon 115 as described above. The physician inflates the expandable balloon 115 through the HA 1B lumen port 153. Balloon inflation first exerts outward pressure on the score line 135 and then on the lesion. Without wishing to be bound by any particular operating principle, we believe that because the movable SCW end 138 is movably connected, the score line 135 does not contribute to balloon deformation caused by inflation or overinflation. Because the line can move outward, it does not significantly shield the balloon. This shielding effect prevents the balloon from inflating beyond the line. However, as inflation continues, some other portions of the balloon will deform due to the pressure exerted by the inflation fluid. In some cases, this balloon deformation can lead to subsequent deflation problems. Instead, the outward inflation pressure acting on the score line 135 causes the movable SCW end 138 to move distally, reducing the reaction force exerted by the score line 135 on the expandable balloon 115. As the movable SCW tip 138 moves distally, it recedes from the hub lumen 145. In some embodiments, the inflation pressure pulls the movable SCW tip 138 out of the hub lumen 145. In other embodiments, the movable SCW tip 138 remains within the hub lumen 145.

[0084] The physician maintains the pressure in the inflatable balloon 115 long enough to allow the score lines 135 to have the desired effect. The physician then releases the pressure, the inflatable balloon 115 deflates, and the movable SCW end 138 re-enters the hub lumen 145.

[0085] Figures 2a to 2c Various embodiments of the SCB catheter 100 are described. Figures 1a to 1c The main difference between these sets of embodiments is the geometry of the hub and the proximal score line.

[0086] Figure 2b The hub 140 is shown having a distal hub portion 241 and a proximal hub portion 242. The proximal hub portion 242 is used to connect the shaft 105 to the handle assembly 150 via the HA step-down portion 156. In addition, the proximal hub portion 242 serves as a stop for the spring 200. The spring 200 includes a spring wire 201—a cross-section of the spring wire 201 is shown in the figure. The spring 200 increases the elasticity of the score line 135 mechanism.

[0087] The hub-shaped distal portion 241 is disposed near the distal end of the spring 200. The hub-shaped distal portion 241 is connected (attached) to the movable SCW end portion 138. In some embodiments, the hub-shaped distal portion 241 is fixed to the movable SCW end portion 138. In other embodiments, the hub-shaped distal portion 241 includes a hub-shaped lumen 145, which in some instances is fixed to the movable SCW end portion 138. The movable SCW end portion 138 flares outward when it reaches the hub-shaped distal portion 241. In this embodiment, on the other hand, Figures 3a to 3c The embodiment shown in FIG includes a movable SCW tip 138 that does not flare when it reaches the hub distal portion 241 .

[0088] In by Figure 1a-6 In operation of one set of embodiments represented by the disclosed device, the physician deploys the inflatable balloon 115 as described above. The physician inflates the inflatable balloon 115 through the HA 1B lumen port 153, which first applies external pressure to the score line 135 and then to the lesion. Figures 1a-3c The operational difference between the illustrated set of embodiments lies in the mechanism that allows movement by the movable SCW tip 138. As in the previously described embodiments, in these embodiments, when the inflatable balloon 115 is inflated, the reaction force that would otherwise be exerted by the score line 135 is mitigated by the movable SCW tip 138. In this set, the movable SCW tip 138 retracts distally, as previously described, but the hub distal portion 241 also moves distally. The arrangement of the hub distal portion 241, the spring 200, and the hub proximal portion 242 applies a force to the movable SCW tip 138 via the hub distal portion 241. This force biases the movable SCW tip 138 proximally. Furthermore, when the physician deflates the balloon, as previously described, the movable SCW tip 138 moves proximally, assisted by the force of the spring 200, substantially returning to its initial position.

[0089] Figure 4a-4b Another embodiment of the SCB catheter 100 is described. The device of this embodiment is substantially similar to the above embodiment. The main difference is that the distal hub portion 241 of this embodiment is similar to the distal hub portion of the above embodiment, but has a narrowed area 340 extending proximally from the distal hub portion 241 (see FIG. Figure 4b The narrowed region 340 is located inside the spring 200 .

[0090] Similarly, Figure 5aThere is a narrowed region 340, and in addition, there is an extension 451 located between the hub distal portion 241 and the narrowed region 340. Located on the extension 451 is a finger grip 400 that extends across the side of the shaft proximal portion 106. The finger grip 400 provides the physician with some control of the distal hub 450, which allows for more direct control of the movable SCW tip 138 in these types of embodiments.

[0091] Figure 6 An embodiment of a proximal portion of a device is disclosed. In this embodiment, a spring 200 is disposed within and extends distally from the distal end of the HA 150. The hub 140 is connected to the HA 150 and forms a single-piece structure therewith. The spring 200 receives the proximal shaft portion 106. Referring to FIG. 1C , it can be appreciated that the movable SCW end 138 exits the score line lumen 1139 near the distal end of the proximal shaft portion 106. The movable SCW end 138 is directly connected to the spring 200 by any suitable method, such as brazing, welding, overmolding, gluing, or press-fitting using plastic tubing. In some embodiments, the movable SCW end 138 is directly connected to the spring 200 via a weld joint 1362. In this or other embodiments, a hub cover 700 is disposed over the hub 140 and the shaft 105. In some instances, the hub cover 700 reduces strain on the connection between the HA 150 and the shaft 105.

[0092] The spring 200 provides longitudinal movement and a biasing force to the movable SCW end 138. When the movable SCW end 138 is subjected to a distally directed force that moves it distally, the movement holds it away from the HA 150. Once the distally directed force disappears, a restoring force or force opposing the distal stretch (a reaction force) will cause the movable SCW end 138 to return substantially to its seat.

[0093] Figure 7a Described Figure 1a FIG2 shows a cross-section BB of the SCB catheter 100. It illustrates two score lines 135, the inflatable balloon 115, the IB lumen 133, and the guidewire lumen 119. It can be seen that the cross-section BB cuts through the SCB catheter 100 at the distal shaft portion 108. The cross-section also cuts through the inflatable balloon 115; cuts through the score line 135 at the SCW IB portion 137, thereby illustrating the SCW cross-section 505; and cuts through the guidewire lumen 119. Figure 7b A similar embodiment is described, but with three score lines 135 .

[0094] Figure 8a Described Figure 1a105. It shows two SCW lumens 1139 arranged side by side. It also shows the IB lumen 133 and the GW lumen 119. The SCW lumens 1139 do not have to be arranged side by side as shown in this figure, but can be arranged distributed around the periphery of the shaft 105.

[0095] Figure 8b Expressed with Figure 1a Similar cross-sectional views of different embodiments. The proximal portion 106 of the shaft is cut proximal to the tapered portion 111 of the shaft. The tapered portion 111 tapers from the proximal portion 106 of the shaft to the middle portion 107 of the shaft. The shaft 105 has a shaft wall 109. For example, Figure 8b Two SCW lumens 1139 are shown, which are arranged opposite each other in the shaft 105. This arrangement does not need to be symmetrical. Also in this figure, the guidewire lumen 119 is arranged within the shaft 105, which shows the SCW lumen 1139 extending longitudinally within the shaft 105. In some embodiments, the SCW lumen is arranged outside the guidewire lumen.

[0096] Figure 9 Expressed Figure 6 1. A cross-sectional view of an embodiment of the present invention along line CC. In this figure, the guidewire lumen 119 is disposed within the shaft 105. In some embodiments, the shaft 105 is an extrusion that provides a guidewire lumen 119, two SCW lumens 1139, and one lumen 133.

[0097] In any of the above embodiments, the inflatable balloon 115 can have any diameter ranging from 1.25-40 mm or 2.0-8.0 mm. In any of the above embodiments, the inflatable balloon 115 can have any length, for example, 10-300 mm or 20-300 mm. Longer balloons can be particularly beneficial for treating peripheral lesions, which typically have longer lesion portions.

[0098] In all of the above systems, a coating (e.g., a hydrophobic or hydrophilic coating) can be added externally to facilitate insertion.

[0099] Suitable drugs or therapeutic agents include the following.

[0100] The antimicrobial agent may, for example, be selected from the group consisting of triclosan, chlorhexidine, nitrofurazone, benzalkonium chloride, silver salts and antibiotics such as rifampicin, gentamicin and minocycline and combinations thereof.

[0101] In certain embodiments, the antimicrobial agent may include triclosan, chlorhexidine, and salts or combinations thereof. Examples of anti-inflammatory agents include steroidal and nonsteroidal anti-inflammatory agents. Examples of nonsteroidal anti-inflammatory drugs include aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonisin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terobamate, and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, aminobenzoylphenylacetic acid, bufenac, indomethacin, clopidogrel, diclofenac sodium, etodolac, felbinac, fenclorac, fenclorac, fenclorac, bisoprolol, glucomannan, ibufenac, indomethacin, trifloxycin, isofenac, clofenac, mefenamic acid, oxamicin, promegastatin, fenfluramine ... amphetamine, succinate, benzophenone, dapoxetine ... Pyrazolones, such as azapropazone, benzylpiperidone, phenazone, morphine, hydroxyphenylbutazone, phenylphenylbutazone, pipebuzone, isopropyl antipyrine, ramifenazone, succinylbutazone, and thiazolidinone; salicylic acid and its derivatives, such as acetaminophen, aspirin, pyraclostrobin, bromosalicylate, calcium acetylsalicylate, diflunisal, etersalate, fentasac, gentisic acid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate, masalazone, morphine salicylate, 1-naphthyl salicylate, olsalazine, parsalamide, phenyl acetylsalicylate, phenyl salicylate, acetylsalicylamide , salicylamide a-acetic acid, salicyl sulfate, salsalate and sulfasalazine; thiazine carboxamides such as daloxicam, isoxicam, piroxicam and tenoxicam; others such as E-6-acetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amitraline, bendazolic acid, pyridoxine, bucuronium, pyridyl biphenylacetamide, bispyribacol, emfazone, guaiac, nabumetone, nimesulide, liver protein, oxacerol, ranitol, pyridoxal, pifoxicam, proquinezone, proxazole and tenidapa; and pharmaceutically acceptable salts thereof.

[0102] Examples of steroidal anti-inflammatory agents (glucocorticoids) include 21-acetoxyprednisolone, alclometasone, algesone, amicinide, beclomethasone, betamethasone, budesonide, cloprednisone, clobetasol, clobetasone, clocortolone, chlorphenirol, corticosterone, corticosterone acetate, cortivazole, deflazacort, denatonide, desoximetasone, dexamethasone, diflusone, flumethasone, difluprednate, glycyrrhetinic acid, fluxacasone, fluclofenac, fludexamethasone, flunisolide, fluocinolone, fluocinolone acetate, fluocinolone, fluocinolone acetate, fluocinolone, flumetholone, fluperone acetate, fluprednil acetate The invention also includes but is not limited to: fluprednisolone, flurandrenolide, fluticasone propionate, flumethasone, halocetolone, halocetolone, halobetasol proopioid, halometasone, haloprednisolone acetate, hydrocortisone, cortisone, loteprednol ethyl carbonate, maleinidone, medrysone, methylprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisone sodium phosphate, prednisone, prednisolone valerate, prednidine, dimethoate, triamcinolone, triamcinolone acetonide, triamcinolone acetonide and pharmaceutically acceptable salts thereof.

[0103] Analgesics include narcotic and non-narcotic analgesics. Narcotic analgesics include alfentanil, allylprodine, alfalfa, ampicillin, benzylmorphine, benzothiazide, buprenorphine, butorphanol, clonitrazine, codeine, codeine bromide, codeine phosphate, codeine sulfate, dihydrodesomorphine, dextromorphamide, dezocine, diaminopropionamide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimesadol, methadone, dimethylthiambutene, morphine butyl ester, dipipanone, eptazocine, ethylheptazine, etonizine, ethylmorphine, ethoxynidazole, fentanyl, hydrocodone, hydromorphone, hydroxymeperidine, Isomethadone, ketobemidone, hydroxymethyllevomorphan, lofentanil, meperidine, meptazocine, metazocine, dapoxetine hydrochloride, metoprolol, morphine, myrophine, nalbuphine, nalbufenine, nalcirene, nicomorphine, norlevorphanol, normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone, opium base, analgesic, phenadol suppository, phenazocine, meta-aminophenethyl ether, dapoxetine, pirithromide, proheptazine, dimethapride, iproperamide, disopyramide propoxyphene, remifentanil, sufentanil, tilidine, and pharmaceutically acceptable salts thereof.Non-narcotic analgesics include aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylic acid, alclofenac, amiprofen, alopolline, aluminum bis(acetylsalicylate), amilclofenac, 2-amino-4-methylpyridine, aminopyrazone, aminopyrine, ammonium salicylate, guaiacine, antipyrine, antipyrine salicylate, antrofenine, azapropazone, aspirin, pyraclostrobin, benoxaprofen, benzylpiperidone, pyralidone, bemoprofen, bromfenac, parabromoacetanilide, 5-bromosalicylate acetate, butaclofenac, bupropion, and bupropion. Hydrazine, butacetin, calcium acetylsalicylate, carbamoyl chloramphenicol, carbifene, casaran, chloralpyrine, clocinol, choline salicylate, atofen, silamadol, clomethacin, baramidamide, cloroethamide, dextromethorphan, diflubenzuron, diflubenzuron, dihydroaluminum acetylsalicylate, dipyridamole, analgin, emfazone, phenethylanthranilate, pyrimidine, ethoxypyrimidine, ethoxaquin, etodolac, felbinac, fenoprofen, flufenamic acid, flufenamic acid, flupirtine, fluprofen, fluprofen, phosphasic acid, gentian Acid, glafenine, isobufenacet, imidazole salicylate, indocin, indoprofen, triflate, isoladol, isonixin, ketoprofen, ketorolac, paraethoxylactanilide, linilide, cloxoprofen, lysine acetylsalicylic acid, magnesium acetylsalicylate, methoxypromazine, methoxyfol, miprofen, morazone, morphine salicylate, naproxen, nefopam, nicotinamide, 5'-nitro-2'-hydroxyacetanilide, parsamide, pyridoxal, phenacetin, phenazopyridine hydrochloride, phenoxazol, phenoxypyridine, acetylsalicylic acid Acid phenyl ester, phenyl salicylate, pheniradol, pipbuzone, peridone, prolidine, propacetamol, isopropyl antipyrine, proxazole, quinine salicylate, ramydone, rimazol mesulfate, acesalicylamide, salicin, salicylamide, salicylamide a-acetic acid, salicylic acid sulfate, salsalate, salverine, simetrol, sodium salicylate, sulfaphenazone, suprofen, talniflumate, tenoxicam, terazosamine, tetrandrine, tinoridine, tolfenamic acid, topronine, tramadol, vimimol, felbinac, zomepirac and pharmaceutically acceptable salts thereof.

[0104] Local anesthetics include hydroxyethylcaine, amoxicillin, amilocaine hydrochloride, oxybuprocaine, benzocaine, betocaine, phensalate, bupivacaine, butacaine, butanben, butancaine, amicaine, butylocaine, carbocaine, cloprodil, caine, cocaethidine, cocaine, cyclomethicone, cinchocaine hydrochloride, quinicaine, dimethocaine, deperidone hydrochloride, dyclonine, ecgonine, ecgonine, ethyl chloride, beta-eucaine, euprocin, phenacamine, morphine, hexylcaine hydrochloride, hydroxytetracaine, isobutylaminobenzoate, Leucaine mesylate, levobenzone, lidocaine, mepivacaine, mepurcaine, mebuvacaine, methyl chloride, myricaine, naecaine, cincaine, oxethacaine, oxethacaine, p-ethoxycaine, phenacaine, phenol, piprocaine, pidocaine, polidocanol, pramoxine, prilocaine, procaine, propancaine, proparacaine, propivacaine, propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropivacaine, salicyl alcohol, tetracaine hydrochloride, tolicaine, mesocaine, zolamine and pharmaceutically acceptable salts thereof.

[0105] Anticonvulsants include alefenal, amoxicillin, amphenicol, atropine, atropine, beverlin mesulfate, bitanverine, fenpropipro, bromobutatropine, scopolamine bromide, caroverine, cimetropium bromide, cinnamidine, clebopride, quinacrine hydrobromide, quinacrine hydrochloride, cyclanin iodide, diphenhydramine, desopamine, fenbutamate, depredine bromide, hexahydrofenin, fenbutamate bromide, etaverine, feclimine, fennoverine, diphenhydramine, fenpentazone bromide, fentropium bromide, flavopyrate, trihydroxyacetone, gluconic acid, guaiac, hydrazine, hydroxymethoxychromene, leopyrrol, mebeverine , moxaverine, naiverine, octamidine, octaverine, oxybutynin hydrochloride, pentapyridine ester, benatamide hydrochloride, phloroglucinol, pinaverine bromide, piperidine alcohol, pipoxolan hydrochloride, pravaverine, pifenonium bromide, iproperidine, propifan, pyromazine, prozapine, racemic pheniramine, roxiverine, spasmololium iodide, sultopium, temozole iodide, tiquidimium bromide, benzamide, triethylbutanone, 3-methylchromone, clover, trimebutine, n,n-1 trimethyltryptophan-3,3-phenylbenzene-propylamine, methoxytropine oxychloride, trospium chloride, xentropium bromide and pharmaceutically acceptable salts thereof.

[0106] In certain embodiments, the therapeutic agent for relieving pain or discomfort may be selected from ketorolac and its pharmaceutically acceptable salts (e.g., tromethamine salts, trade name ), 4-diethylamino-2-phenylcyclohexyl ethanol butyl ester and their pharmaceutically acceptable salts (such as 4-diethylamino-2-phenylcyclohexyl glycolic acid butyl ester hydrochloride, also known as oxybutynin chloride, trade name ) and combinations thereof. The amount of therapeutic agent present will depend, for example, on the efficacy of the therapeutic agent used, the release rate, etc. One skilled in the art can readily determine the appropriate therapeutic agent loading to achieve the desired result.

[0107] In some embodiments, the surface of the IB 115 is embossed with any pattern. For example, in some embodiments, the surface of the IB 115 is embossed with a checkered pattern. Additionally, in some embodiments, the inflatable balloon 115 tapers along its longitudinal direction.

[0108] In some embodiments, the score line 135 is disposed within the SCW lumen 1139 . And in some embodiments, the SCW lumen 1139 is disposed on the exterior of the shaft 105 .

[0109] Although the present invention has been described with reference to specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, the present invention encompasses all such alternatives, modifications, and variations that fall within the spirit and scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, just as if each individual publication, patent, or patent application was specifically and individually incorporated herein. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. A scoring balloon catheter comprising: a shaft comprising a distal region, a distal end, and a proximal end; an inflatable balloon mounted at a distal region of the shaft; an inflation lumen having a distal end and a proximal end, wherein the distal end of the inflation lumen terminates within the interior of the balloon; a guidewire lumen disposed inside the shaft; a handle mounted at the proximal end of the shaft, the handle having: a guidewire port connected to the proximal end of the guidewire lumen; and a balloon inflation port connected to the proximal end of the inflation lumen; a spring coaxially mounted within the shaft at the distal end of the handle, the spring having a distal region, wherein the spring is disposed within the distal end of the handle and extends distally from the handle; at least two score line lumens disposed proximate to each other within the interior of the shaft on one side of the shaft, proximate to the guidewire lumen, having distal ends beginning proximal to the balloon and proximal ends ending distal to the spring; At least two score lines, each score line within a score line lumen, the score lines having: an end portion mounted on the shaft and positioned between the distal end of the shaft and the balloon; a middle portion that longitudinally traces the exterior of the balloon; a proximal portion located within the scored lumen; and The proximal end is fixed on the spring.

2. The scoring balloon catheter according to claim 1, wherein: The shaft is made of polymer.

3. The scoring balloon catheter according to claim 1 or 2, wherein: The proximal ends of the two score lines are welded to the spring.

4. The scoring balloon catheter according to claim 1, wherein: The spring is arranged to apply a biasing force that acts to oppose distal movement of the proximal end of the at least one score line.

5. The scoring balloon catheter according to claim 1, wherein: The proximal ends of the two score lines are secured to the spring by one of welding, overmolding, gluing, or press-fitting using a plastic tube.

6. The scoring balloon catheter according to claim 1, further comprising a hub, wherein: The spring is arranged around the shaft and partially within the hub.

7. The scoring balloon catheter according to claim 6, wherein: The proximal end is attached to the outer surface of the spring.

8. The scored balloon catheter according to claim 7, further comprising two to eight score lines, wherein: Each score line lumen is connected to one or more score lines.

9. The scoring balloon catheter according to claim 4, wherein: The movable proximal end of the score line is gradually inclined outward.

10. The scoring balloon catheter according to claim 4, wherein: The spring is arranged to apply a biasing force that acts to oppose distal movement of the proximal ends of the two score lines.

11. The scoring balloon catheter according to claim 5, wherein: The welding is brazing.

12. The scoring balloon catheter according to claim 8, wherein: The score lines are housed within connected score line lumens.

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