Scoring balloon catheter with enhanced pushability and steerability

Abstract

The present application relates to a device for introduction into a body vessel, comprising a shaft (105), a balloon (115) at a distal end of the shaft (105), and at least one longitudinal scoring line (135) for scoring a vessel lesion, the scoring line being attached to the distal end of the shaft (105) and arranged above the balloon (115). The shaft (105) comprises a support (119), e.g. a wire or tube, having one or more helical cut portions (119A, 119B) that improve pushability and trackability, enabling use with an external guidewire in the form of a "short rapid exchange" (SRX). The balloon (115) is inflated when fluid is delivered to the balloon (115) through an inflation lumen. The inflation will push the scoring line and the guidewire against the vessel lesion.

Description

[0001] INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in the specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND

[0003] Balloon catheters are used to treat lesions in blood vessels. However, difficulties are encountered in navigating through tortuous anatomy and safely crossing very tight lesions. Also, some lesions are difficult to dilate using a balloon alone, and require focused force to dilate the lesion at a safe inflation pressure.

[0004] U.S. Patent No. 6,394,995 to Solar et al. describes a system for providing enhanced force to treat lesions. The system has a flexible advancement member with a tracking member that is slidable over a guide wire and a balloon with a distal end attached to the tracking member. This type of system provides limited focused force and no enhanced pushability (e.g., kink resistance) and maneuverability. SUMMARY

[0005] According to one aspect of the present invention, a balloon catheter provides enhanced pushability and maneuverability due to the omission of an internal guide wire and the inclusion of a support member (e.g., a wire or tube) having one or more helical cut or spring-like portions.

[0006] In one aspect, the present invention relates to a balloon catheter having a shaft with a proximal portion, a distal portion, and a support member extending from the proximal portion to the distal portion of the shaft. At least a portion of the support member includes a helical cut portion. A hub is mounted on the proximal portion of the shaft, and an inflatable balloon is mounted on the distal portion of the shaft. At least one score line is also provided, the at least one score line having a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon, a second end connected to the proximal portion of the shaft, and an intermediate portion extending alongside the inflatable balloon.

[0007] In one embodiment, the support member includes a tube. The helical cut portion of the tube can be located within the distal portion of the shaft, within the hub, or both. The support member can alternatively include a wire, which can also be located within the distal portion of the shaft, within the hub, or both.

[0008] The balloon catheter can include a spring for connecting the second end of the score line to the proximal portion of the shaft. The at least one score line can include two score lines, and the shaft can include lumens for each score line. The distal portion of the shaft includes a guide wire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon.

[0009] According to another aspect of the invention, the balloon catheter includes a shaft having a proximal portion, a distal portion, and a support extending from the proximal portion to the distal portion, at least a portion of which includes a helical cut portion. A hub-shaped portion is mounted on the proximal portion of the shaft, and an inflatable balloon is mounted on the distal portion of the shaft, the distal portion of the shaft including a guidewire lumen having an inlet distal to the balloon and an outlet distal to the inflatable balloon. At least one scribe line includes: a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon; a second end connected to the proximal portion of the shaft; and an intermediate portion extending alongside the inflatable balloon.

[0010] In one embodiment, the second end of the at least one scribed line is movably connected to the proximal portion of the shaft. The support may include a tube, with a helically cut portion of the tube located within the distal portion of the shaft or within a hub (or both). Alternatively, the support may include a wire, which may be similarly positioned.

[0011] Another aspect of the invention relates to a balloon catheter comprising a shaft having a proximal portion, a distal portion, and a support line extending from the proximal portion to the distal portion, at least a portion of the support line including a helical cut portion. A hub-shaped portion is mounted on the proximal portion of the shaft, and an inflatable balloon is mounted on the distal portion of the shaft.

[0012] In one embodiment, the balloon catheter includes at least one grooved line having: a first end fixed to the shaft between a distal end and an inflatable balloon; a second end connected to a proximal portion of the shaft; and an intermediate portion extending alongside the inflatable balloon. The second end is movably connected to the proximal portion of the shaft. A spring may also be provided for connecting the second end of the grooved line to the proximal portion of the shaft. The at least one grooved line may include two grooved lines, and the shaft may include lumens for each grooved line.

[0013] In one embodiment, the helical cut portion of the support wire is located within the distal portion of the shaft. In another embodiment, the helical cut portion of the support wire is located within the hub portion. The distal portion of the shaft may include a guidewire lumen having an inlet distal to the inflatable balloon and an outlet distal to the inflatable balloon. Attached Figure Description

[0014] The above and other advantages of the present invention can be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0015] Figure 1 This is a front view of an example of a etched balloon catheter.

[0016] Figure 1A yesFigure 1 enlarged view of an indicated portion of

[0017] Figure 1B Figure 1 enlarged view of an indicated portion of

[0018] Figure 2 is a front view of another example of the device of the present invention.

[0019] Figure 2A enlarged view of an indicated portion of Figure 2

[0020] Figure 2B enlarged view of an indicated portion of Figure 2

[0021] Figure 3 is an enlarged view of a distal end of a scoring balloon catheter according to one aspect of the present invention.

[0022] Figure 4 is a view of a support for a catheter.

[0023] Figure 4A is a first cross-sectional view of the support.

[0024] Figure 5A is an end view of an embodiment of Figure 1 at section BB.

[0025] Figure 5B are viewing cross-sections of different inventive embodiments, similar to Figure 5A

[0026] Figure 6A is a cross-sectional view of an embodiment of the device taken along a section similar to section AA of Figure 1

[0027] Figure 6B are viewing cross-sections AA of different inventive embodiments, similar to Figure 6A

[0028] In the interest of clarity, the dimensions of some of the elements in the drawings can be exaggerated relative to others, or several physical components can be included in one functional block or element. Furthermore, the reference numerals in the drawings can be repeated among the figures for elements that can have some similarity in certain cases. Moreover, some of the blocks in the drawings can be combined into a single function block or element. In addition, the order in which some or all of the blocks appear in the drawings can be different than in other instances. DETAILED DESCRIPTION

[0029] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, it will be understood by those skilled in the art that the disclosed embodiments can be practiced without these specific details. In other instances, well-known methods, procedures, components or structures have not been described in detail so as not to obscure the application.​​​​​​

[0030] The present application relates to systems and methods for vascular treatment. The principles and operation of the systems and methods of the present application can be better understood with reference to the accompanying drawings and the additional description.

[0031] This application is not limited to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The application is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

[0032] For clarity, certain features of the application that are, for brevity, described in the singular are also provided in combination in a single embodiment. Conversely, features of the application that are, for brevity, described in the plural are also provided singly or in any appropriate subcombination.

[0033] Turning to the embodiments of the present application, Figure 1 An embodiment of the device of the present application is illustrated. In the embodiment of the present application, the scoring balloon catheter 100 is represented in a front view, with selected portions represented in enlarged view. The catheter 100 includes a shaft 105 having a shaft proximal portion 106 connected to a shaft mid-portion 107 and a shaft distal portion 108 connected to the shaft mid-portion 107. A shaft taper 111 connects the shaft proximal portion 106 to the shaft mid-portion 107. The shaft 105 also includes a shaft wall 109 that provides a degree of rigidity to the shaft 105 to make the shaft 105 suitable for tracking into the vasculature or tortuous vasculature, which is neither too rigid nor too flexible. The shaft 105 can include a polymeric material, such as Pebax.

[0034] In some embodiments, the shaft taper 111 is fixed to the shaft mid-portion 107. In some embodiments, the shaft wall 109 ends before the shaft distal end or tip 110. The shaft distal end 110 is the end of the shaft 105 that enters the patient first and can include a tip 110 that includes a lumen suitable for receiving a guidewire G. This creates a so-called "short rapid exchange" or "SRX" configuration, which is a configuration in which the guidewire G extends outside of the catheter 100 and thus does not require an internally extending guidewire and the associated complexities that can arise therefrom.

[0035] The catheter 100 also includes an inflatable balloon 115. The inflatable balloon 115 is mounted on the shaft 105 along the shaft distal portion 108. In some embodiments, the inflatable balloon 115 terminates at the shaft distal end 110. In these or other embodiments, the inflatable balloon 115 is fixed to the shaft 105.

[0036] The inflatable balloon 115 includes an inflatable balloon proximal end 130 and a distal end 131. A typical embodiment has a flexible polymeric membrane that serves as the inflatable balloon 115 and has an outer surface 132. For the present invention, the inflatable balloon proximal end 130 is the portion of the inflatable balloon 115 that attaches or secures the proximal end of the inflatable balloon 115 to the shaft 105. The inflatable balloon proximal end 130 is defined as the proximal portion of the inflatable balloon 115 that remains in contact with the shaft 105 after the inflatable balloon 115 is inflated.

[0037] For the present invention, the inflatable balloon distal end 131 is the portion of the inflatable balloon 115 that attaches or secures the distal end of the inflatable balloon 115 to the shaft 105. The inflatable balloon distal end 131 is defined as the distal portion of the inflatable balloon 115 that remains in contact with the shaft 105 after the inflatable balloon 115 is inflated. The inflation lumen 133 is in fluid communication with the inflatable balloon 115, which enables the inflatable balloon 115 to inflate by passage of fluid therethrough.

[0038] The catheter 100 also includes a hub 140. The hub 140 is located within the shaft 105 and within the shaft proximal portion 106. The hub 140 includes a passage 141 for the passage of the support 119 therethrough. The hub 140 also includes one or more hub lumens 145.

[0039] The catheter 100 also includes a support 119, which can take the form of a solid wire or a hollow tube (e.g., a hypotube) and can be made of a metal (e.g., stainless steel, silver, platinum, titanium, or any other biocompatible metal or similar material). The support 119 can extend longitudinally at least from the shaft proximal end 112 (e.g., from within the hub 140) to near the shaft distal end or tip 110. At least a portion of the support 119 (e.g., the portion located within the hub 140) can be functionally altered so as to provide increased flexibility. This can be accomplished by providing the portion of the support 119 with a helical cut portion 119A, as shown in Figure 1A The helical cut portion 119A can be accomplished, for example, by laser cutting and essentially forms a spring-like portion of the support 119. This helps to provide the shaft 105 with sufficient rigidity (considering the lack of an internal guidewire) and thus improved trackability of the catheter 100, while maintaining a high degree of pushability. This feature also helps to avoid kinking due to the provided inflatable balloon, particularly when the balloon is inflated and the shaft 105 diameter is thus increased.

[0040] The catheter 100 can also include one or more score lines 135, where, Figure 1 , 1AOnly one such line is shown in the embodiment of Figures 1A and IB extending alongside the balloon 115 (the guidewire G also extends alongside the balloon to provide scoring functionality). This scoring line 135 can have a fixed end 136, a portion 137 extending alongside the balloon, and a movable end 138. The fixed end 136 is connected within the shaft distal portion 108 distally of the distal end of the inflatable balloon 131. In some embodiments, the fixed end 136 is attached on the outside of the shaft wall 109. The fixed end 136 can be attached using any method known to those of ordinary skill in the art. This configuration provides a focused force element (the scoring line 135) alongside the inflatable balloon 115.

[0041] The distance between the scoring line 135 and the outer surface 132 can be any value deemed useful by those of ordinary skill in the art. Once past the inflatable balloon 115, the scoring line 135 can extend proximally under the shaft wall 109 and inside the shaft 105. The movable end 138 is located inside the shaft 105 within the shaft proximal portion 106. In some embodiments, the scoring line 135 occupies at least a portion of the lumen 1139 (see Figure 1C) of the shaft 105. In some embodiments, the scoring line 135 is a wire, a shape memory wire, a polymer, or a shape memory polymer. Figure 6A 6B

[0042] Figure 1 1A Figures 1A and IB depict a catheter 100 having two scoring lines, one of which is a translatable scoring line 135 and the other of which is a guidewire G. In some embodiments, the catheter 100 has 1-15, 3-10, or 2-5 scoring lines. In some embodiments, the scoring line 135 has a diameter 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 scoring line 135 is 0.10 inches. The scoring line 135 need not have a uniform diameter, and can have a larger diameter at the distal end than at the proximal end. In some embodiments, the scoring line 135 comprises a metal, a metal alloy, a polymer, and a shape memory material based on metal or based on polymer.

[0043] In some embodiments, the interaction portion comprises the movable scoring line end 138 connected in or to the hub lumen 145. In some embodiments, the movable scoring line end 138 is fixed to the hub lumen 145. In other embodiments, the interaction portion comprises the movable scoring line end 138 slidably engaged inside the hub lumen 145. In some embodiments, the hub 140 comprises any biocompatible material, such as a metal, a metal alloy, and a polymer. In some embodiments, the hub 140 comprises nylon, Pebax, or any other suitable material.

[0044] ​​​In some embodiments, the hub portion 140 is substantially fixed within the proximal portion 106 of the shaft, and the movable scribe line end 138 is slidably engaged or disposed within the hub portion cavity 145. In some embodiments, the hub portion 140 is longitudinally movable or resilient, thereby allowing the movable scribe line end 138 to move longitudinally by pulling the hub portion 140 distally, by moving the hub portion 140, or by stretching the material of the hub portion 140. For example, in some embodiments, the hub portion 140 is resilient. This movement stretches the hub portion 140 when the movable scribe line end 138 is subjected to a distally directed force that moves it distally, and when the movable scribe line end 138 is fixed to or within the hub portion cavity 145. When the distally directed force is removed, a restoring force or a force opposite to the distal stretching (reaction force) will cause the movable scribe line end 138 to substantially return to its position.

[0045] The scribing guide 100 may also include a handle assembly 150. The handle assembly 150 is connected to the proximal end 109 of the shaft. The handle assembly 150 may include a transition subassembly 152, which includes a stepped descent portion 156, wherein the overall external dimensions have a stepped transition decreasing to a smaller diameter, and its dimensions are configured to engage the proximal end 112 of the shaft. In some embodiments, the transition subassembly 152 does not have the stepped descent portion 156.

[0046] Shaft 105 is associated with handle assembly 150 via shaft proximal end 112 and stepped descent portion 156. In some embodiments, shaft 105 is connected to handle assembly 150. For example, shaft proximal end 112 is slidable on stepped descent portion 156, and the components can be secured, for example, by welding, fusion, adhesive bonding, etc. The frictional fit between shaft proximal end 112 and transition subassembly 152 is strong enough to hold the components together. In some embodiments without stepped descent portion 156, shaft proximal end 112 can be connected to handle assembly 150 via a mating joint between shaft proximal end 112 and transition subassembly 152.

[0047] The handle assembly 150 may include a port 154. The port 154 delivers gas or expansion fluid through the lumen 120 into the inflatable balloon 115 to inflate it, or delivers gas or expansion fluid out of the inflatable balloon 115 to deflate it.

[0048] In terms of operation, under the leadership of... Figure 1 In the apparatus taught in the embodiments, for example to treat calcified lesions, a physician cuts through the patient's tissue until a blood vessel of appropriate size is exposed. The blood vessel must then lead to the lesion site along a pathway that the catheter 100 can follow. In some embodiments, the location of the lesion site may lead to the selection of a shaft 105 or catheter 100 with different flexibility.

[0049] The physician opens the blood vessel, inserts a guidewire into the blood vessel, and advances the guidewire through the patient's vasculature under ultrasound, magnetic resonance, fluoroscopy, or some other type of guidance. Once the physician has positioned the guidewire G at a satisfactory location, the physician threads the proximal end of the guidewire into the distal guidewire lumen that is connected to the tip 110, the inlet and outlet of which are distal to the balloon 115. With the guidewire G in place and connected to the catheter 100, the physician steers the catheter 100 along the guidewire G until the inflatable balloon 115 reaches the desired location near the lesion site. Typically, this location will allow at least one score line 135 to effectively engage the lesion portion. Thereafter, the physician inflates the inflatable balloon 115 until the score line 135 is firmly pressed into the lesion portion or causes the lesion portion to rupture. Once the lesion treatment with the catheter 100 is complete, the physician deflates the inflatable balloon 115, which allows the score line 135 to relax away from the lesion portion and the vessel wall.

[0050] The score line 135 contacts the lesion portion as long as the inflatable balloon 115 remains inflated. The inflation time corresponds to the time that the physician chooses for the score line 135 to contact the lesion portion. The inflation time can range from 5 seconds to 5 minutes. The nature of the lesion portion can dictate the appropriate inflation time and inflation rate.

[0051] When the inflatable balloon 115 is inflated, the score line (or score lines) 135 expands outward, such that the score line 135 is placed under longitudinal tension. The force vector caused by this longitudinal tension has a component that points proximally from the fixed end 136 and distally from the movable end 138. Thus, any movement of the score line 135 occurs at the movable end 138. The hub 140 constrains the movement of the movable end 138, allowing it to move longitudinally. This movement reduces the strain on the inflatable balloon 115, helping to maintain its engineered shape and helping to avoid any kinking.

[0052] When the physician deflates the balloon 115, the force that previously inflated the score line 135 is removed, allowing the score line 135 (and the movable end 138) to relax. The hub 140 limits the relaxation of the movable end 138. In particular, the hub 140 guides the movable end 138 into a similar structure as the initial structure of the movable end 138 prior to the inflation of the balloon. The action of the hub 140 helps to regularize the inflation and deflation steps, increasing their predictability.

[0053] Figure 1A is a magnified view of the shaft proximal portion 106. The shaft 105 terminates at the shaft proximal end 112 and receives the hub 140, which is or is not part of the distal end 155. The hub 140 can have one or more hub lumens 145, Figure 1AThe hub-shaped lumen 145 is shown. In this embodiment, the hub-shaped lumen 145 extends longitudinally into the hub-shaped portion 140. The conduit 100 does not require the longitudinal hub-shaped lumen 145 to function properly. The hub-shaped lumen 145 is only needed for slidably and reversibly receiving the movable end 138. Figure 1A This indicates that the hub-shaped lumen 145 extends into the hub-shaped portion 140 to approximately three-quarters of its length, but this is not significant. In some embodiments, the hub-shaped lumen 145 extends completely through the hub-shaped portion 140. The hub-shaped lumen 145 extends into the hub-shaped portion 140 as far as the movable end 138 extends into the hub-shaped lumen 145.

[0054] Figure 1A The diagram also shows a scribe line 135 and a movable end 138. In this embodiment, the scribe line 135 tapers or widens outward after exiting the lumen 1139 proximally. The movable end 138 occupies a portion of the hub-shaped lumen 145. In this embodiment, where more than one scribe line is present, the catheter 100 includes one hub-shaped lumen 145 for each movable end 138. Other embodiments exist in which the hub-shaped lumen can interact with more than one movable end 138.

[0055] Figure 1B This is an enlarged view showing the region where the scribe line 135 exits distally from the lumen 1139. The scribe line 135 has a passageway through a portion of the catheter 100. The lumen 1139 is a lumen along the axial intermediate portion 107 that receives the scribe line 135. After exiting, the scribe line 135 flares outward as it advances distally, extending in a generally longitudinal direction until the line passes the distal end 131 of the balloon. At this point, the scribe line 135 turns inward until it reaches the axial distal portion 108. The fixed end 136 of the scribe line is attached to the catheter 100 distal to the inflatable balloon 115 or at or near the point where the distal end 131 of the balloon is attached to the catheter 100. The portion of the scribe line 135 within portion 137 has a longitudinal region along the inflatable balloon 115.

[0056] In the Figure 1In operation of a set of embodiments represented by the device in FIG. 1, a physician deploys the inflatable balloon 115 as described above. The physician inflates the inflatable balloon 115 through the lumen port 154. The balloon inflation first exerts outward pressure on the score line 135 and the guidewire G and forces them into engagement with the lesion. Without wishing to be bound by any particular theory of operation, it is believed that because the movable end 138 is movably connected, the score line 135 does not contribute to balloon deformation caused by inflation or over inflation. Because the line 135 and the guidewire G can move outward, their presence does not significantly trap the balloon, which prevents the balloon 115 from expanding beyond the line. As inflation continues, some other portion of the balloon 115 will deform due to the pressure exerted by the inflation fluid. In some cases, balloon deformation leads to problems later in deflation of the balloon. Instead, the outward inflation pressure on the score line 135 causes the movable end 138 to move distally, which reduces the counter force exerted by the score line 135 on the inflatable balloon 115. As the movable end 138 moves distally, it recedes from the hub lumen 145. In some embodiments, the inflation pressure causes the movable end 138 to pull out of the hub lumen 145. In other embodiments, the movable end 138 remains inside the hub lumen 145.

[0057] The physician maintains the pressure in the inflatable balloon 115 for a sufficient amount of time for the score line 135 to have the desired effect. Thereafter, the physician releases the pressure, the inflatable balloon 115 deflates, and the movable end 138 re-extends into the hub lumen 145.

[0058] Figure 2 、 2A FIGS. 1A and IB represent different embodiments of the scoring balloon catheter 100, the main difference being in the hub and proximal score line geometry. Figure 2B The hub 140 is shown, which has a hub distal portion 241 and a hub proximal portion 242. The hub proximal portion 242 is used to connect the shaft 105 to the handle assembly 150 through the step down portion 156. In addition, the hub proximal portion 242 serves as a stop for the spring 200. The spring 200 includes a spring wire 201 that adds elasticity to the mechanism of the score line 155.

[0059] The hub distal portion 241 is located near the distal end of the spring 200. The hub distal portion 241 is connected (attached) to the movable end 138. In some embodiments, the hub distal portion 241 is fixed to the movable end 138. In other embodiments, the hub distal portion 241 includes a hub distal lumen 145 that can be fixed to the movable end 138. When the movable end 138 reaches the hub distal end portion 241, the movable end 138 flares outwardly. The guide wire G also extends through a guide wire lumen in the tip 110 that is distal to the balloon distal end 131.

[0060] As in the above embodiments, the scoring line 135 modulates the otherwise applied reaction force by the movable end 138 when the inflatable balloon 115 is inflated. As previously described, the movable end 138 moves distally, but the hub distal portion 241 also moves distally. The structure of the hub distal portion 241, the spring 200, and the hub proximal portion 242 exerts a force on the movable end 138 through the hub distal portion 241. This force tends to bias the movable end 138 proximally. And when the physician deflates the balloon (as previously described), the movable end 138 moves proximally with the help of the spring 200 force, substantially returning to its original position.

[0061] Figure 3 Embodiments of the distal portion of the catheter 100 are disclosed. As shown, the support 119 can extend the entire length of the balloon 115 to the tip 110 of the catheter 100. Also shown in this figure is that the portion of the support 119 that extends along the balloon 115 can be functionally altered as described above, for example by being formed from a helically cut wire or tube, thereby creating a spring-like portion. Again, this is considered to assist in providing sufficient rigidity to the shaft 105 and thus improve the trackability of the catheter 100, while maintaining a high pushability, given the lack of an internal guide wire.

[0062] Figure 4 It is shown that the support 119 can comprise an elongate wire having a helically cut portion 119A. Although shown at the distal end, it will be appreciated that it can be located elsewhere, for example at the proximal end. It is also possible to provide more than one helically cut portion, for example portion 119B. From Figure 4 It will also be appreciated that the support 119 can have a length L that can be at least as great as the distance D from the distal tip 110 of the catheter to the proximal end of the hub 140, as Figure 1 shown in the figure. Figure 4A It is also shown that the support 119 has a solid cross-sectional area when in the form of a wire, except for the helically cut portion 119A, but as described above, the support can also comprise a hollow tube. In any case, the resulting portions 119A, 119B are spring-like and flexible, given the helical cutting as described.

[0063] Figure 5A represents a cross-section BB of Figure 1 . It represents the scoring line 135, the guidewire G, the inflatable balloon 115, the inflation lumen 133 and the support 119. It can be seen that the cross-section BB cuts through the catheter 100 at the shaft distal portion 108. The plane also cuts the inflatable balloon 115; at the balloon portion 137 it cuts the scoring line 135, thereby representing a cross-section 505. Figure 5B represents a similar embodiment, but with two scoring lines 135, and also a guidewire G, which can also provide the scoring function.

[0064] Figure 6A represents a cross-section AA of Figure 1 . It represents two lumens 1139 in the shaft 105, which are placed side by side for receiving the scoring line (not shown) when there are two scoring lines. It also represents the inflation lumen 133 for receiving the support 119 (wire or rod) and the lumen 120. The lumens 1139 need not take the side-by-side configuration as shown in the figure, but can take a configuration distributed around the circumference of the shaft 105. A single lumen 1139 can also be provided.

[0065] Figure 6B represents a different embodiment with two lumens 1139, each for receiving a scoring line (not represented) distributed in the shaft 105 crossing each other. This distribution need not be symmetrical, and there can be only one scoring line, in which case only one such lumen would be needed. Also in this figure, the lumen 120 for the support is located within the shaft 105, and is coaxial with the double inflation lumen 133.

[0066] In any of the embodiments described above, the inflatable balloon 115 can have any of a variety of diameters in the range of 1.25-40 mm or 2.0-8.0 mm. In any of the embodiments described above, the inflatable balloon 115 can have any of a variety of lengths, such as 10-300 mm or 20-300 mm. Longer balloons can be particularly advantageous for treating peripheral lesions, which often have a longer diseased portion.

[0067] Although it is preferred to include a scoring line, it is also understood that the catheter 100 can be useful without a scoring line, for example by providing angioplasty, without cutting or scoring the lesion. In such an embodiment, the support 119, whether in the form of a tube or a wire, having one or more helical cutting portions 119A, can extend the entire length of the shaft 105, for example from the proximal portion to the distal portion of the catheter 100, including the balloon 115.

[0068] In summary, the present invention can be considered to relate to the following:

[0069] 1. A balloon catheter comprising:

[0070] a shaft having a proximal portion, a distal portion, and a support extending from the proximal portion to the distal portion of the shaft, at least a portion of the support comprising a helically cut and / or spring-like portion;

[0071] a hub mounted on the proximal portion of the shaft;

[0072] an inflatable balloon mounted on the distal portion of the shaft; and

[0073] at least one score line having a first end fixed to the shaft between the distal portion of the shaft and the inflatable balloon, a second end connected to the proximal portion of the shaft, and an intermediate portion extending alongside the inflatable balloon.

[0074] 2. The balloon catheter of claim 1, wherein the support comprises a tube.

[0075] 3. The balloon catheter of claim 2, wherein the helically cut and / or spring-like portion of the tube is located within the distal portion of the shaft.

[0076] 4. The balloon catheter of claim 2, wherein the helically cut and / or spring-like portion of the tube is located within the hub.

[0077] 5. The balloon catheter of claim 1, wherein the support comprises a wire.

[0078] 6. The balloon catheter of claim 5, wherein the helically cut and / or spring-like portion of the wire is located within the distal portion of the shaft.

[0079] 7. The balloon catheter of claim 5, wherein the helically cut and / or spring-like portion of the wire is located within the hub.

[0080] 8. The balloon catheter of any one of claims 1-7, further comprising a spring connecting the second end of the score line to the proximal portion of the shaft.

[0081] 9. The balloon catheter of any one of claims 1-8, wherein the at least one score line comprises two score lines, and optionally, the shaft comprises a lumen for each score line.

[0082] 10. The balloon catheter of any one of claims 1-9, wherein the distal portion of the shaft comprises a guidewire lumen having an inlet distal to the balloon and an outlet distal to the inflatable balloon.

[0083] 11. The balloon catheter of claim 10, further comprising a guidewire extending through the guidewire lumen and including a portion extending alongside the balloon.

[0084] 12. A balloon catheter, comprising:

[0085] a shaft having a proximal portion, a distal portion, and a support extending from the proximal portion to the distal portion, at least a portion of the support comprising a helically cut and / or spring-like portion;

[0086] a hub mounted on the proximal portion of the shaft;

[0087] an inflatable balloon mounted on the distal portion of the shaft, the distal portion of the shaft comprising a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon; and

[0088] at least one score line having a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon, a second end connected to the proximal portion of the shaft, and an intermediate portion extending alongside the inflatable balloon.

[0089] 13. The balloon catheter of claim 12, wherein the second end of the at least one score line is movably connected to the proximal portion of the shaft.

[0090] 14. The balloon catheter of claim 12 or claim 13, wherein the support comprises a tube.

[0091] 15. The balloon catheter of claim 14, wherein the helically cut portion of the tube is located within the distal portion of the shaft.

[0092] 16. The balloon catheter of claim 43, wherein the helically cut portion of the tube is located within the hub.

[0093] 17. The balloon catheter of claim 12 or claim 13, wherein the support comprises a wire.

[0094] 18. The balloon catheter of claim 17, wherein the helically cut portion of the wire is located within the distal portion of the shaft.

[0095] 19. The balloon catheter of claim 17, wherein the helically cut portion of the wire is located within the hub.

[0096] 20. The balloon catheter of any one of claims 12 to 19, further comprising a guidewire extending through the guidewire lumen and including a portion extending alongside the balloon.

[0097] 21. A balloon catheter, comprising:

[0098] a shaft having a proximal portion, a distal portion, and a support wire extending from the proximal portion to the distal portion, at least a portion of the support wire comprising a helical cut and / or spring-like portion;

[0099] a hub mounted on the proximal portion of the shaft; and

[0100] an inflatable balloon mounted on the distal portion of the shaft.

[0101] 22. The balloon catheter of claim 21, further comprising at least one score line having a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon, a second end coupled to the proximal portion of the shaft, and an intermediate portion extending alongside the inflatable balloon.

[0102] 23. The balloon catheter of claim 21, wherein the second end is movably coupled to the proximal portion of the shaft.

[0103] 24. The balloon catheter of claim 21 or claim 22, further comprising a spring for coupling the second end of the score line to the proximal portion of the shaft.

[0104] 25. The balloon catheter of any one of claims 21-24, wherein the at least one score line comprises two score lines, and the shaft optionally comprises a lumen for each score line.

[0105] 26. The balloon catheter of any one of claims 21-25, wherein the helical cut and / or spring-like portion of the support wire is located within the distal portion of the shaft.

[0106] 27. The balloon catheter of any one of claims 21-25, wherein the helical cut and / or spring-like portion of the support wire is located within the hub.

[0107] 28. The balloon catheter of any one of claims 21-27, wherein the distal portion of the shaft comprises a guidewire lumen having an inlet distal of the inflatable balloon and an outlet distal of the inflatable balloon.

[0108] 29. The balloon catheter of claim 28, further comprising a guidewire extending through the guidewire lumen and comprising a portion extending alongside the balloon.

[0109] While the application has been described in connection with specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific embodiments thereof, it will be understood that many modifications, changes, and variations will be specific

Claims

1. A balloon catheter, the balloon catheter comprising: A shaft having a proximal portion, a distal portion, and a solid support line extending from the proximal portion to the distal portion of the shaft, at least a portion of the support line including a helical cut portion; A hub-shaped portion, which is mounted on the proximal end portion of the shaft; An inflatable balloon, the inflatable balloon being mounted on the distal portion of the shaft; as well as At least one scribe line having: a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon; a second end connected to the proximal portion of the shaft; and an intermediate portion extending beside the inflatable balloon.

2. The balloon catheter according to claim 1, wherein: The spiral-cut portion of the support line is located within the distal portion of the shaft.

3. The balloon catheter according to claim 1, wherein: The spiral-cut portion of the support line is located inside the hub-shaped section.

4. The balloon catheter according to claim 1, further comprising: A spring, the spring being used to connect the second end of the scribe line to the proximal portion of the shaft.

5. The balloon catheter according to claim 1, wherein: The at least one scribe line includes two scribe lines, and the shaft includes a lumen for each scribe line.

6. A balloon catheter, said balloon catheter comprising: A shaft having a proximal portion, a distal portion, and a solid support line extending from the proximal portion to the distal portion, at least a portion of the support line including a helical cut portion; A hub-shaped portion, which is mounted on the proximal end portion of the shaft; An inflatable balloon, the inflatable balloon being mounted on a distal portion of a shaft, the distal portion of the shaft including a guidewire lumen having an inlet distal to the inflatable balloon and an outlet distal to the inflatable balloon; and At least one scribe line having: a first end fixed to the shaft between the distal end of the shaft and the inflatable balloon; a second end connected to the proximal portion of the shaft; and an intermediate portion extending alongside the inflatable balloon.

7. The balloon catheter according to claim 6, wherein: The second end of at least one scribed line is movably connected to the proximal portion of the shaft.

8. The balloon catheter according to claim 6, wherein: The spiral-cut portion of the support line is located within the distal portion of the shaft.

9. The balloon catheter according to claim 6, wherein: The spiral-cut portion of the support line is located inside the hub-shaped section.

10. The balloon catheter according to claim 6, further comprising: A guidewire that extends through a guidewire lumen and includes a portion extending alongside an inflatable balloon.

11. A balloon catheter, said balloon catheter comprising: A shaft having a proximal portion, a distal portion, and a solid support line extending from the proximal portion to the distal portion, at least a portion of the support line including a helical cut portion; A hub-shaped portion, said hub-shaped portion being mounted on the proximal end portion of the shaft; and An inflatable balloon is mounted on the distal portion of the shaft.

12. The balloon catheter according to claim 11, wherein: The second end is movably connected to the proximal portion of the shaft.

13. The balloon catheter according to claim 12, further comprising: At least one scribe line, the scribe line having: a first end, the first end being fixed to the shaft between the distal end of the shaft and the inflatable balloon; a second end, the second end being connected to the proximal portion of the shaft; and an intermediate portion extending beside the inflatable balloon; as well as A spring, the spring being used to connect the second end of the at least one scribed line to the proximal portion of the shaft.

14. The balloon catheter according to claim 13, wherein: The at least one scribe line includes two scribe lines, and the shaft includes a lumen for each scribe line.

15. The balloon catheter according to claim 11, wherein: The spiral-cut portion of the support line is located within the distal portion of the shaft.

16. The balloon catheter according to claim 11, wherein: The spiral-cut portion of the support line is located inside the hub-shaped section.

17. The balloon catheter according to claim 11, wherein: The distal portion of the shaft includes a guidewire lumen having an inlet distal to the inflatable balloon and an outlet distal to the inflatable balloon.

18. The balloon catheter of claim 17, further comprising: A guidewire that extends through a guidewire lumen and includes a portion extending alongside an inflatable balloon.

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