Multi-function Balloon Catheter

Abstract

An improved multi-function balloon catheter is presented having multiple balloons and lumens that can be inserted into blood vessels (arteries or veins or microvasculature) in specific areas of the human body to perform a combination of therapeutic procedures including, but not limited to, widening narrowed or blocked blood vessels to allow improved blood flow therethrough, performing stent / implant delivery and placement to ensure the blood vessel remains open, and localized / targeted delivery of various treatments / therapeutic agents to diseased areas within the blood vessel.

Description

[Technical field]

[0001] Cross-references to related patents This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63,135,730, entitled "COMBINATION BALLOON CATHETER," filed on January 10, 2021, which is incorporated by reference in its entirety herein.

[0002] The present invention relates generally to medical devices, and more particularly to a multi-function balloon catheter that can be inserted into a blood vessel (artery or vein) in a particular region of the human body to perform a combination of procedures such as procedures performed to open a narrowed or blocked blood vessel to allow improved blood flow, procedures performed to deliver various therapeutic agents to diseased areas within the blood vessel, procedures performed to insert a stent within the blood vessel and ensure that a blood vessel once opened remains open by inflating the balloon of the balloon catheter, and / or combinations thereof. [Background technology]

[0003] A number of balloon catheters are known in the art that are used to dilate a stenosed area within a lumen, such as a blood vessel (e.g., a coronary or peripheral artery), during percutaneous transluminal angioplasty (PTA) and stent placement procedures. During use of such known catheters, typically an angioplasty balloon mounted on the catheter is inflated within the stenosed blood vessel at the location of an atheroma or plaque deposit to shear and break wall components of the vessel and widen the lumen of the vessel to improve blood flow. If necessary, a stent is inserted and secured within the vessel after the balloon dilation procedure to ensure that the dilated stenosed area remains open.

[0004] Examples of some balloon catheters in the prior art include US7740609, which discloses a catheter assembly with a guide catheter, a balloon catheter with a stabilizing balloon and a steering balloon, and an optional guidewire. As disclosed in the patent, one of the two balloons may be located inside the catheter and another balloon may be located outside the catheter. The balloons may optionally be arranged in a collinear relationship disposed around the same catheter. As disclosed in the patent, while treating an obstruction in the body, a catheter system with two balloons is first advanced to the desired site of the obstruction, then the first balloon is inflated to engage the inner surface of the catheter, and then finally the second balloon is inflated to engage the surface of the body cavity.

[0005] US5788708 discloses a balloon stent delivery catheter and method for deploying stents in human blood vessels.

[0006] US7658744 discloses a multiple balloon catheter equipped with cutting blades.

[0007] US4445892 discloses a dual balloon catheter for use with optical systems in blood vessels, particularly arteries. The catheter includes two spaced apart expandable balloons for occluding a segment of the blood vessel. The device also includes a first channel for flushing the occluded segment, the optical system used in the segment, and a second channel for introducing fluid into the blood vessel distal to the device.

[0008] US5318531 discloses a balloon catheter that can be used to apply drugs to the blood vessel wall, for example to the site of a stenosis. As disclosed in the patent, the balloon is a catheter that delivers drugs through a lumen. The balloon includes holes sized to allow the drug to pass outwardly therethrough, and the outer surface of the balloon includes a substantially hydrophilic tubular microporous membrane covering the holes and disrupting the flow of drug.

[0009] US2011 / 0060276 discloses a balloon catheter useful for delivering therapeutic agents into body vessels.

[0010] US6997898 discloses a catheter and a method for using the catheter for site-specific delivery of a drug to or collection of a drug from a biological space. The catheter includes an inflatable balloon that, when inflated at a target segment of the biological space, creates a closed drug delivery pocket for delivery or collection of a drug from a defined space.

[0011] US8088103 discloses a multi-lumen, multi-balloon catheter used, inter alia, for occlusion, visualization, irrigation, drainage, and delivery of drugs to treatment areas within blood vessels in the human body. The catheter proposed in US '103' includes an elongated catheter shaft having a longitudinal axis and defining five lumens therein. At its distal end, the catheter has an atraumatic tapered distal tip. The catheter includes a distal occlusion balloon located proximal to the tapered distal tip along the longitudinal axis of the catheter, a space-occupying balloon located proximal to the distal occlusion balloon, and a proximal occlusion balloon located proximal to the space-occupying balloon. Between the distal occlusion balloon and the space-occupying balloon is an aspiration segment, and between the space-occupying balloon and the proximal occlusion balloon is a drug delivery segment. Each of the aspiration segment and the drug delivery segment has at least one skive port formed therein. A proximal end adapter connected to the catheter includes an occluding balloon inflation hub and a delivery hub. As described in the '103' patent, when only the distal and proximal occlusion balloons are inflated and the space-filling balloon is deflated, a relatively large treatment volume remains within the occluded vessel lumen. This large volume is particularly undesirable when delivering rare or expensive drugs to treat diseased vessels, and potentially harmful when delivering toxic drugs, as larger amounts of those drugs are required. Thus, the larger the treatment volume, the greater the cost and risk. On the other hand, the inflation of the space-occupying balloon dramatically reduces the space remaining within the occluded vessel lumen, thereby increasing the effective dosage of the delivered drug while simultaneously reducing the amount of drug required. The space-occupying balloon is inflated to a degree that does not contact the vascular endothelium, so that the entire area of ​​the endothelium between the inflated distal and proximal occlusion balloons is exposed to the delivered drug. From the disclosure of the '103' patent, it is clear that the patent discloses a three-balloon catheter for performing a procedure to deliver drugs or various therapeutic agents to diseased areas within a vessel.

[0012] Thus, while there have been various types of balloon catheters in the past, including those with multiple balloons for performing various medical procedures, the purpose of such existing balloon catheters was to perform a single therapeutic procedure at a given time, such as PTA or stent placement or drug delivery (using a coating or using an occlusive balloon catheter). When multiple therapeutic procedures are performed at a particular lesion site in a blood vessel, existing balloon catheters need to be inserted into the blood vessel multiple times, thereby increasing the cost of the treatment and requiring the patient to undergo multiple procedures, increasing the possibility of procedural complications and associated morbidity.

[0013] Because of the clinical need for improved solutions, the inventors herein propose a balloon catheter that can combine multiple therapeutic procedures in a single insertion, potentially improving safety and efficacy. Summary of the Invention

[0014] The present invention proposes an advanced balloon catheter design and method of use that may allow a combination of therapeutic procedures to be performed simultaneously with a single insertion, potentially increasing clinical safety and efficacy.

[0015] The inventors herein propose a multi-functional and improved multi-balloon and multi-lumen balloon catheter that can be inserted into blood vessels in specific regions of the human body to perform a combination of therapeutic procedures such as widening narrowed or blocked blood vessels to allow improved blood flow therethrough, inflating the balloon of the balloon catheter to perform delivery of a stent or suitable implant to ensure that the blood vessel remains open once opened, and delivering various therapeutic agents to the affected area within the isolated / sealed section of the blood vessel.

[0016] An embodiment of the present invention discloses a multi-lumen, multi-function balloon catheter comprising an elongate catheter body having a tip, a proximal end, and a distal end, the elongate catheter body being made up of a first port, a second port, a third port, a fourth port, and a fifth port, a first balloon having a predetermined shape and size mounted on the catheter and selectively inflated and deflated in a selected blood vessel using the first port, and a second balloon and a third balloon having a predetermined shape and size mounted on the catheter at the proximal and distal ends, respectively, the second balloon and the third balloon being selectively inflated and deflated in a selected blood vessel using the second port and the third port, respectively. Further, the fourth and fifth ports are configured for delivery and extraction of various therapeutic and / or biological agents to and from the blood vessel during or after a medical procedure.

[0017] In another embodiment of the invention, the body of the catheter embodies a stent or suitable implant selectively configured on the first balloon. The stent or implant is inserted, delivered and expanded in the selected vessel with the expansion of the first balloon of the catheter, after which the first balloon is deflated and the catheter carrying the first balloon is removed, optionally leaving or disposing the stent at the desired location in the vessel, to ensure that the vessel once opened by the expansion of the first balloon of the balloon catheter remains open. However, as an essence of the proposed invention, when delivering the stent or implant or widening the blocked vessel by the expanded balloon, other procedures may be performed at the same time, such as the delivery or extraction of various therapeutic agents to the affected area.

[0018] According to an embodiment, the second and third balloons are mounted on the catheter at the proximal end and when the distal end is inflated, they create a seal at the point of contact with the blood vessel. This seal can help to retain the delivered therapeutic agent within the sealed area of ​​the blood vessel for a period of time. This allows the therapeutic agent to be isolated / confined between the second and third balloons and also allows the excess therapeutic agent to be completely extracted, thereby maximizing the effect of the agent and minimizing / preventing the loss / migration of the agent to other undesirable parts of the human body.

[0019] According to another embodiment, the multi-function balloon catheter of the present invention may further comprise one or more electrodes in the first balloon and attached to the catheter body. The electrodes are adapted to generate waves or vibrations that flow towards the wall of the lesion and aid in impinging the lesion section adjacent to the first balloon. The waves or vibrations, such as but not limited to ultrasonic vibrations, provide a continuous vibration or perforation effect on some calcium / hard atherosclerotic lesions, including calcified deposits, opening up the occluded or narrowed selected sections. The waves may be mechanical waves (such as sound waves, ultrasound waves, pressure waves) capable of propagating through air, fluids, and solids, or atomic waves capable of propagating through air, fluids, solid materials, or vacuum. This may include, but is not limited to, electromagnetic waves such as line frequency waves.

[0020] These and other features, advantages and different embodiments of the present invention will become apparent from the following detailed description taken in light of the accompanying drawings. [Brief description of the drawings]

[0021] The above summary, as well as the following detailed description of the preferred embodiments, will be better understood when read in conjunction with the appended drawings, in which exemplary embodiments are illustrated, but the application is not limited to the particular systems and methods disclosed in the drawings.

[0022] [Figure 1]1 illustrates a combination balloon catheter of the present invention, according to an exemplary embodiment of the present invention. [Diagram 2] 1 illustrates a combination balloon catheter of the present invention, according to an exemplary embodiment of the present invention. [Diagram 3] FIG. 1 shows a cross-sectional view of a combination balloon catheter tube having a multi-port hub connected to a five-lumen catheter tube according to an exemplary embodiment of the present invention. [Figure 4] FIG. 1 shows a cross-sectional view of a combination balloon catheter tube having a multi-port hub connected to a four-lumen catheter tube, according to an exemplary embodiment of the present invention. [Diagram 5] 1 illustrates the insertion and placement of a combination balloon catheter into the lumen of a blood vessel to open a narrowed or blocked blood vessel during a balloon dilation procedure. [Figure 6] 6 shows the combination balloon catheter of FIG. 5 with the first balloon in an inflated position. [Figure 7] The combination balloon catheter of FIG. 6 is shown with the second and third balloons in inflated positions in conjunction with the first balloon to create a seal at each location. [Figure 8] FIG. 8 shows the combination balloon catheter of FIG. 7 with the first balloon in a deflated position after a stenosed or blocked blood vessel has been opened. [Figure 9] 9 shows the combination balloon catheter of FIG. 8 in which a therapeutic agent is delivered and retained within the sealed region formed by the inflated second and third balloons. [Figure 10] 10 shows the combination balloon catheter of FIG. 9 where the therapeutic agent has been extracted from the sealed area. [Figure 11] 13 shows the second and third balloons in a deflated position after the balloon dilation procedure or extraction of therapeutic agent is complete and the combination balloon catheter is withdrawn after the medical procedure is completed. [Figure 12]1 illustrates the delivery of a stent at the location of a plaque deposit or obstruction within the lumen of a blood vessel as part of a balloon dilation procedure to open an obstructed blood vessel using the combination balloon catheter of the present invention. [Figure 13] 1 illustrates the delivery of a stent at the location of a plaque deposit or obstruction within the lumen of a blood vessel as part of a balloon dilation procedure to open an obstructed blood vessel using the combination balloon catheter of the present invention. [Figure 14] 1 illustrates an alternative embodiment of the proposed combination balloon catheter of the present invention, which may be useful for several other specific applications. [Figure 15] 1 illustrates an alternative embodiment of the proposed combination balloon catheter of the present invention, which may be useful for several other specific applications. [Figure 16] 13 illustrates another alternative embodiment of a combination balloon catheter of the present invention having two electrodes configured within a balloon attached to the catheter body. [Figure 17] 13 shows another alternative embodiment of the combination balloon catheter of the present invention having an electrode structure with multiple wave / vibration sources in the form of a coil about the catheter body. [Figure 18] FIG. 17 is a side view of the combination balloon catheter of FIG. 16 showing the arc between the electrodes and the wave / vibration flow that aids in impinging on a selected section or diseased section adjacent to the first balloon. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] We now consider in detail some embodiments illustrating the features. The words "comprising," "having," "containing," and "including," as well as other forms thereof, are intended to be equivalent and open-ended in that the item or items following any one of these words are not meant to be an exhaustive list of such item or items, nor are they meant to be limited to only the item or items listed. It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Although any methods and systems similar or equivalent to those described herein can be used in the practice or testing of the embodiments, the preferred methods and systems are described herein. The disclosed embodiments are merely exemplary.

[0024] References to "one embodiment," "another embodiment," "example," "other examples," "alternative embodiments," "some embodiments," and the like indicate that the embodiment or example so described may include a particular feature, structure, characteristic, property, element, or limitation, but not all embodiments or examples necessarily include that particular feature, structure, characteristic, property, element, or limitation. Moreover, repeated use of the phrase "in an embodiment" does not necessarily refer to the same embodiment.

[0025] As used in this application, the terms "catheter", "balloon catheter", "combination balloon catheter", and the like refer to a flexible tube that is inserted into the human body, particularly into a blood vessel (artery or vein), to dilate plaque deposits on the sidewall of the blood vessel to improve blood flow, to deliver a stent after the blood vessel has been widened, and / or to deliver various therapeutic agents (drugs, medicines, and the like) into the vessel to facilitate the effective performance of a medical procedure, recovery process, treatment, and the like. Furthermore, the terms "lesion", "plaque", and the like are used synonymously for the purposes of this application and refer to any deposit on the vessel wall that leads to a narrowing of the blood vessel that would prevent normal blood flow. For the purposes of the present invention, the terms "selected section", "lesion origin", "lesion section", "calcified lesion", and the like all refer to a diseased portion or area of ​​a blood vessel where the blood vessel has narrowed and the passageway / lumen has been narrowed due to the deposition of plaque on the vessel wall.

[0026] Furthermore, the proposed catheter device, which will now be described in detail with respect to Figures 1-15, is not limited to use for percutaneous transluminal coronary angioplasty (PTCA), but rather may be used during a variety of percutaneous transluminal angioplasty (PTA) procedures performed to widen narrowed or blocked arteries or veins, ranging from the coronary arteries of the heart to the small capillaries and veins (commonly referred to as the "microvasculature"), and further to the peripheral arteries and veins, including the arteries and veins of the legs, arms, etc. Various features and embodiments of the present invention are better described in conjunction with Figures 1-15.

[0027] 1 and 2, a multi-lumen, multi-function balloon catheter 10 is shown. The balloon catheter 10 includes an elongated catheter body 12 having a tip 12a, a proximal end 12b, and a distal end 12c. The balloon catheter 10 includes a first balloon 13 having a predetermined shape and size mounted on the catheter body 12 at a first portion 12d. When a medical procedure is being performed to dilate a lesion, the balloon 13 is selectively inflated and deflated within a selected section of a blood vessel. The balloon 13 is inflated or deflated using a first port 16 configured on the first portion 12d of the catheter body 12. The first balloon 13 is adapted to inflate or deflate a selected section or lesion 32 of a blood vessel 30. When inflated to open, it presses against and makes contact (partially or completely) with the inside 13c, 13d of the selected section 32 of the blood vessel 30 (see Figures 5 and 6). The portion of the catheter body 12 to which the balloon 13 is attached further embodies a pair of radiopaque marker bands 13a, 13b representing opposite ends of the balloon 13. In other words, each of the pair of radiopaque marker bands 13a, 13b is present at the two ends of the balloon 13. These radiopaque marker bands 13a, 13b serve to identify the ends of the balloon 13 or the exact location of the balloon 13 within the blood vessel where the medical procedure is being performed.

[0028] The balloon catheter 10 also includes a second balloon 15 and a third balloon 14 having a predetermined shape and size mounted on the catheter body 12 on either side of the first balloon 13 at the proximal end 12b and the distal end 12c, respectively. The second balloon 15 is mounted on the catheter body 12 at the second portion 12e, and the third balloon 14 is mounted on the catheter body 12 at the third portion 12f. The balloons 14, 15 are selectively inflated and deflated within a selected section of the blood vessel where the medical procedure is being performed to form a seal at a contact point 50 within the blood vessel 30 (as shown in FIG. 8). The balloons 15 and 14 are inflated or deflated using a second port 20 and a third port 19, respectively. The second and third ports 20, 19 are configured on the second and third portions 12e, 12f of the catheter body 12. The second and third portions 12e, 12f of the catheter body 12 to which the balloons 15 and 14 are attached further embody respective pairs of radiopaque marker bands 15a, 15b and 14a, 14b (referred to as a first pair of radiopaque marker bands 15a, 15b and a second pair of radiopaque marker bands 14a, 14b) configured on either side of the balloons 15 and 14. The pairs of radiopaque marker bands 13a and 13b, 14a and 14b, and 15a and 15b help medical professionals to locate the ends of the balloons 13, 14, 15, respectively, during the balloon expansion procedure. In a preferred embodiment, the balloons 14 and 15 located on either side of the balloon 13 may be identical in shape and size. In some other embodiments, the balloons 14 and 15 may be different in shape and size from each other. Additionally, in preferred embodiments, balloon 13 may be larger in size, and preferably in length, than balloons 14 and 15 located on either side of balloon 13. In some other embodiments, balloon 13 may be similar in size, diameter, and length to balloons 14 and 15 located on either side of balloon 13.

[0029] Further, according to embodiments, balloon 13 may have an essentially substantially cylindrical shape, and balloons 14 and 15 on either side of balloon 13 may have an essentially substantially spherical shape. Further, according to embodiments, balloon 13 may be made of an incompatible or semi-compatible material, and balloons 14 and 15 may be made of a semi-compatible or compliant material. Examples of incompatible materials include high pressure inflatable materials, typically made of polyester or nylon, where balloons made of this type of material (such as balloon 13) can be subjected to high pressure to expand to a certain diameter and open occlusions or dilate the vasculature. On the other hand, examples of compliant materials include, but are not limited to, polyurethane or silicone (essentially elastomers). Examples of semi-compliant materials include Pebax or high durometer polyurethanes, such as, but not limited to, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylene, polyurethane, crosslinked low density polyethylene (PET), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends, and ionomer resins. Other suitable balloon materials may also be used.

[0030] Additionally, the catheter body 12 additionally includes a fourth port 18 and optionally a fifth port 17 located on either side of the balloon 13 for delivery and extraction of various therapeutic agents within the diseased / selected section 32 of the blood vessel 30 during or after the medical procedure. The therapeutic agents may include several specific drugs, biologically active agents, antiplatelet agents, anticoagulants, antithrombotic and fibrolytic agents, anti-inflammatory agents, antibodies, and the like, which may be delivered individually in solution form, in combination, or in combination with nanoparticles such as lipids, gold, carbon, and the like. Although the preferred embodiment discloses the presence of separate ports 18, 17 for the delivery and extraction of the therapeutic agents, it may be possible to only have a common port (rather than two) for the delivery and extraction of the therapeutic agents. In the embodiment with separate ports 18, 17, the ports 18, 17 may be connected to individual lumens to allow the delivery of multiple therapeutic agents, optionally simultaneously (requiring two lumens in the catheter body 12). According to the embodiment, when the balloons 14, 15 are inflated during the dilatation procedure, the balloons 14, 15 form a seal at the contact points 50 with the blood vessel 30 (as seen in FIG. 8), creating a sealed area 55 (as seen in FIG. 8). The ports 17, 18 for injection or delivery of a therapeutic agent 60 (as shown in FIG. 9) are positioned so that the agent 60 remains within the sealed area 55 of the blood vessel 30 for a period of time ranging from a few seconds to 15 minutes, or optionally longer.

[0031] According to an embodiment, the catheter body / tube 12 consists of five lumens, each lumen connected to a dedicated port 25 of the multi-port hub 22 as seen in Fig. 3. As seen in Fig. 3, the multi-port hub 22 is connected to the catheter tube 12. In the example shown, the hub 22 consists of five ports (however, only four ports are visible, since one guidewire lumen port is not visible), and each of these four ports can be connected to a respective lumen within the catheter tube / catheter body 12 for at least inflation / deflation of the balloon 13 through port 16, inflation / deflation of the balloon 14 through port 19, inflation / deflation of the balloon 15 through port 20, and delivery / extraction of therapeutic agents through ports 17, 18. Furthermore, according to an alternative embodiment, the catheter body / tube 12 can consist of six lumens instead of five lumens. Of the six lumens, three lumens are dedicated to each of the balloons 13, 14, 15 for individually inflating and deflating the balloons 13, 14, 15, one is for delivery of the therapeutic agent 60, one is a lumen dedicated to extraction or aspiration of the therapeutic agent 60, and the remaining one is for guidewire guidance.

[0032] According to another embodiment, the catheter tube 12 may consist of four lumens instead of five with a common lumen for inflating / deflating the balloons 14, 15, each lumen connected to a dedicated port 25 of the multi-port hub 22. As seen in Fig. 4, the multi-port hub 22 is connected to the catheter tube 12. In the example shown, the hub 22 consists of four ports (however, only three ports are visible, since one guidewire lumen port is not visible), and each of these three ports of the hub 22 may be connected to a respective lumen in the catheter tube 12 for at least inflation / deflation of the balloon 13 (through port 16), inflation / deflation of the balloons 14 and 15 (through ports 19 and 20), and delivery / extraction of therapeutic agents (through ports 17, 18).

[0033] Next, the operation of the proposed combination balloon catheter 10 and a balloon dilation procedure performed using the proposed combination balloon catheter 10 of the present invention will be described with reference to FIGS.

[0034] To begin a balloon dilation procedure to open or widen a blockage in a stenosed or occluded blood vessel 30 (e.g., a coronary or peripheral artery), a guidewire 40 is first inserted into the lumen 36 of the blood vessel 30 to act as a rail for the balloon catheter 10, as shown in FIG. 5. As is known, in a balloon dilation procedure, the guidewire 40 is directed to a selected section of the vascular stenosis using X-ray monitoring / visualization. Further, as seen in FIG. 5, the catheter 10 is guided in such a manner that the guidewire 40 passes through the central lumen of the catheter tube 12. As shown, the catheter 10 is inserted over the guidewire 40 and the balloon 13 is positioned to cover the length of the lesion or plaque 32, with the balloons 15 and 14 on either side of the balloon 13 remaining aligned with the proximal and distal ends 32a, 32b of the lesion 32, respectively. Optionally, the catheter 10 can be positioned such that the balloons 15 and 14 are aligned with healthier sections of the vessel 30 (away from the proximal and distal ends 32a, 32b of the lesion 32). Typically, a catheter 10 having an appropriate balloon size can be selected based on the diameter or length of the lesion.

[0035] 6, the balloon 13 is inflated to open the occluded / narrowed selected section of the blood vessel 30 or to widen the lumen 36 of the blood vessel 30 at the origin of the lesion 32. The balloon 13 is inflated to a predetermined pressure or volume using a port 16 connected to the internal lumen of the catheter 10, which is then connected to a port in the hub 22 through which a suitable fluid, such as, for example, radiopaque saline, is delivered to inflate the balloon 13.

[0036] In a next step, as seen in Figure 7, following inflation of balloon 13, balloons 14 and 15 located on either side of balloon 13 are inflated. Optionally, balloons 14 and 15 may be inflated simultaneously. Upon inflation, balloons 14 and 15 create a seal at contact points 50 with blood vessel 30. Balloons 14 and 15 are inflated using ports 19, 20 connected to the inner lumen of catheter 10, which in turn are connected to ports in hub 22 through which a suitable fluid, such as, for example, radiopaque saline, is delivered to inflate balloons 14, 15.

[0037] In the next step, as seen in Figure 8, the balloon 13 is deflated using the same port 16. As can be seen, as the balloon 13 is deflated, the vessel 30 is widened / opened at the origin of the lesion 32 and remains open to allow increased blood flow. In this step, the deflation of the balloon 13 also creates a sealed area 55 between the two balloons 14 and 15.

[0038] 9, a therapeutic agent 60 (e.g., a drug, pharmaceutical, nanoparticle, functionalized nanoparticle, etc.) is delivered into the sealed region 55 through the port 18. The port 18 is internally connected to a lumen of the catheter 10, which is then connected to a dedicated port in the hub 22 through which the agent 60 is injected and delivered into the sealed region 55. This step may preferably be performed simultaneously with the deflation of the balloon 13, i.e., as the balloon 13 is deflated, the therapeutic agent 60 is delivered while continuously replacing the deflated volume of the balloon 13 to prevent any potential collapse of the blood vessel.

[0039] In a next step, as seen in FIG. 10 (which looks the same as FIG. 8), once the treatment agent 60 is delivered into the sealed area 55, the delivered agent 60 is then extracted through the port 17. In another embodiment, if the agent 60 is therapeutically effective and safe for the user / patient, the agent 60 may be allowed to flow down into the blood (without requiring a step of extracting the agent 60). In a next step, as shown in FIG. 11, the balloons 14 and 15 are then deflated using the ports 19 and 20, respectively, to open the sealed area 55, and the catheter tube 12 is released and pulled back, followed by the guidewire 40 to complete the balloon expansion procedure. This step may optionally be performed simultaneously with the insertion of saline, i.e., saline is delivered while continuously replacing the extracted volume of the treatment agent 60 as it is extracted, to prevent any potential collapse of the blood vessel.

[0040] 12 and 13, the above-described balloon 13 is shown having a stent 35 surrounding the balloon 13. A balloon catheter 10 is shown. The proposed balloon catheter 10 of the present invention can be used as a stent delivery system according to this embodiment. Figures 12 and 13 specifically show the delivery of a stent 35 into a lumen 36 of a blood vessel 30 at the location of a plaque / lesion deposit 32 as part of a balloon dilation procedure performed to open an occluded blood vessel using the combination balloon catheter 10 of the present invention.

[0041] 14 and 15 show an alternative embodiment of the proposed combination balloon catheter 10 of the present invention, which may be useful for some other specific applications. In particular, FIG. 14 shows a cross-sectional view of the catheter (similar to that described above in FIG. 1 and FIG. 2) with only the presence of balloon 13 and balloon 15. The embodiment shown in FIG. 14 can optionally be used for the treatment of coronary lesions, specifically lesions occurring near the distal end of the artery. Ports 17 can be present on both sides of balloon 13 in this embodiment. Optionally, balloon 15 can maintain only a partial seal to allow for the continuation of partial blood supply distally. Similarly, FIG. 15 shows a cross-sectional view of the catheter (similar to that described above in FIG. 1 and FIG. 2) with only the presence of balloon 15. This embodiment of the proposed combination balloon catheter 10 is preferably deployed for the treatment of microvasculature, i.e., the delivery of therapeutic agents to the microvasculature, e.g., the coronary microvasculature. The balloon 15 presses against and contacts (partially or completely) the inside 13c, 13d of the selected section of the blood vessel 30 or the selected lesion 32 when inflated to widen the selected section or lesion 32 of the blood vessel 30 and deliver one or more therapeutic agents 60 into the selected section or lesion 32 of the blood vessel 30. In these embodiments, the balloon 15 may not be used to widen the lesion section 32.

[0042] Figures 16 and 17 show alternative embodiments of the present invention. In particular, Figure 16 shows a combination balloon catheter 10 of the present invention having two electrodes configured in a first balloon and attached to the catheter body. Thus, the catheter 10 is similar to that described above with respect to Figures 1-13, except for the presence of electrodes 72 and 74. The electrodes are attached to the catheter body 12 (located on the first portion 12d). The electrodes 72, 74 are further attached to a high voltage pulse source 80. The electrodes 72 and 74 are made of metal and are spaced apart to allow a reproducible arc to occur at a given voltage and current. The electrical arc between the electrodes 72 and 74 in the fluid (which aids in the inflation of the balloon 13) is used to generate waves or vibrations in the fluid. These pulses / waves create a continuous vibration or perforation effect on some calcium / hard atherosclerotic lesions, including calcified deposits, opening up selected sections that have been blocked or narrowed. The wave motion may include mechanical waves (such as sound waves, ultrasound waves, pressure waves) that can propagate on air, water / fluid, and metal, or electromagnetic waves that can propagate on air, solid materials, or vacuum. A variable power supply 80 is used to deliver a stream of pulses to the electrodes 72 and 74 to create a wave or vibration stream within the balloon 13 and within the selected section 32 of the blood vessel 30 having the lesion being treated. The magnitude of the wave motion can be controlled by controlling the magnitude, current, and duration and repetition rate of the pulse voltage. FIG. 18 shows a side view of the combination balloon catheter of FIG. 16 showing the arc between the electrodes and the wave stream. The wave or vibration serves to strike the selected section or lesion section adjacent to the first balloon 13. The generated wave or vibration 95 propagates through the fluid and strikes the lesion section continuously. This action serves to easily open the stenosed or occluded selected section 32. In many cases, particularly in patients with an older history of stenosis or calcified lesions 32, simply inflating the balloon 13 may not be sufficient to open the calcified lesion 32 in the blood vessel 30.Thus, in such cases, application of the wave motion 95 in conjunction with inflation of the balloon 13 creates more pressure on the inner wall of the lesion 32, thereby increasing the likelihood of widening the narrowed or blocked blood vessel and improving blood flow therethrough.

[0043] FIG. 17 shows another alternative embodiment of the combination balloon catheter of the present invention having an electrode structure configured in the form of a coil around the catheter body and having multiple wave sources. As in the embodiment shown in FIG. 16, the catheter 10 includes an electrode structure 90 in the form of a coil. The electrode structure 90 is configured on the first portion 12d of the catheter body 12. The electrode structure 90 includes an insulated wire 92 wound around the catheter body 12. The insulated wire 92 may include multiple openings 94 that expose corresponding separate portions of the insulated wire conductor to the fluid (e.g., saline) filled within the balloon 13 for inflation. Each opening 94 forms a corresponding wave source / electrode 96. The electrode structure 90 also includes a counter electrode 74. The counter electrode 74 functions as a common electrode for creating an electric arc between each of the electrodes 96 and the electrode 74 when an appropriate high voltage is applied between the electrodes 96 and the counter electrode 74. As explained above, the electrodes 74 and 96 are attached to a high voltage pulse source 80. The variable high voltage pulse generator 80 is used to deliver a stream of pulses to the electrodes 96 and 74 to create a wave or oscillatory flow within the balloon 13 and within the selected section 32 of the blood vessel 30 containing the lesion being treated.

[0044] The combination balloon catheter 10 and its associated components, such as the balloons 13, 14, 15, and other facilitating means, such as the multi-port hub 22 connected to the tubing of the catheter, may be made using a wide range of materials in different dimensions.

[0045] The foregoing description has been presented with reference to various embodiments. Those skilled in the art and technicians to which this application pertains will appreciate that modifications and variations in the described structure and methods / steps of operation may be made without meaningfully departing from the principles, spirit and scope of the invention.

Claims

1. A multi-function balloon catheter (10), comprising: an elongate catheter body (12) having a tip (12a), a proximal end (12b) and a distal end (12c); a first balloon (13) having a predetermined shape and size mounted on the first portion (12d) of the elongated catheter body (12); a second balloon (15) and a third balloon (14) having a predetermined shape and size, the second balloon (15) and the third balloon (14) being mounted on the second portion (12e) and the third portion (12f) of the catheter body (12) on either side of the first balloon (13) at the proximal end (12b) and the distal end (12c) of the catheter body (12), respectively; the first balloon (13), the second balloon (15), and the third balloon (14) are selectively inflated or deflated to perform at least one of a procedure for widening a selected section of a blood vessel (30) or a lesion origin (32) to allow improved blood flow therethrough, a procedure for delivering one or more therapeutic agents into the selected section of the blood vessel (30), and a procedure for deploying a stent or implant (35) into the selected section of the blood vessel (30); when the second balloon (15) and the third balloon (14) are inflated within the selected section (32) of the blood vessel (30), they form a sealed region (55) extending between contact points (50) of the second balloon (15) and the third balloon (14) with the blood vessel (30); A multi-function balloon catheter (10) in which, when the first balloon (13) is inflated to widen the selected section or lesion (32) of the blood vessel (30), it presses against and at least partially contacts the inside (13c, 13d) of the selected section (32) of the blood vessel (30).

2. 2. The multi-function balloon catheter (10) of claim 1, wherein the elongated catheter body (12) includes a first port (16) located on the first portion (12d) for selectively inflating or deflating the first balloon (13) within the selected section (32) of the blood vessel (30) when a medical procedure is performed to dilate a lesion.

3. The elongated catheter body (12) having the first balloon (13) mounted thereon.

2. The multi-function balloon catheter (10) of claim 1, wherein the first portion (12d) of the catheter comprises a pair of radiopaque marker bands (13a, 13b).

4. 2. The multi-function balloon catheter (10) of claim 1, wherein the second balloon (15) and the third balloon (14) are selectively inflated or deflated using second ports (20) and third ports (19) configured on the second portion (12e) and the third portion (12f) of the catheter body (12), respectively.

5. 5. The multi-function balloon catheter (10) of claim 4, wherein the inflation of the second balloon (15) and the third balloon (14) forms a seal at their contact points (50) with the selected section (32) of the blood vessel (30).

6. 5. The multi-function balloon catheter (10) according to claim 4, wherein each of the second portion (12e) and the third portion (12f) of the catheter body (12) on which the second balloon (15) and the third balloon (14) are mounted further comprises a first pair of radiopaque marker bands (15a, 15b) and a second pair of radiopaque marker bands (14a, 14b) configured at both ends of the second balloon (15) and the third balloon (14), respectively.

7. 2. The multi-function balloon catheter (10) of claim 1, wherein the second balloon (15) and the third balloon (14) located on either side of the first balloon (13) are similar in shape and size or different in shape and size.

8. 2. The multi-function balloon catheter (10) of claim 1, wherein the first balloon (13) is sized larger than the second balloon (15) and the third balloon (14) or similarly sized to the second balloon (15) and the third balloon (14).

9. 2. The multi-function balloon catheter (10) of claim 1, wherein the second balloon (15) is sized larger than the third balloon (14) or similarly sized to the third balloon (14).

10. The multi-function balloon catheter (10) of claim 1, wherein the first balloon (13) is substantially cylindrical.

11. The multi-function balloon catheter (10) of claim 1, wherein the second balloon (15) and the third balloon (14) are substantially spherical.

12. 2. The multi-function balloon catheter (10) of claim 1, wherein the first balloon (13) is made of a non-compliant or semi-compliant material that can expand to a certain diameter and apply high pressure to the wall (13c, 13d) of the blood vessel (30).

13. The multi-function balloon catheter (10) of claim 12, wherein the non-compliant or semi-compliant material is selected from the group of materials consisting of polyester, nylon, polyurethane, and silicone.

14. The multi-function balloon catheter (10) of claim 1, wherein the second balloon (15) and the third balloon (14) are made of a semi-compliant or compliant material.

15. The semi-compliant or compliant material may be polyurethane, silicone, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylene, polyurethane.

15. The multi-function balloon catheter (10) of claim 14, wherein the material is selected from the group of materials consisting of tan, cross-linked low density polyethylene (PET), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomer resins.

16. 3. The multi-function balloon catheter (10) of claim 2, further comprising at least one port (18, 17) located on either one or both sides of the first balloon (13) for delivering and extracting one or more therapeutic agents (60) within the selected section (32) of the blood vessel (30) during or after the medical procedure.

17. 17. The multi-function balloon catheter (10) of claim 16, wherein the one or more therapeutic agents (60) comprise drugs, biologically active agents, antiplatelet agents, anticoagulants, antithrombotic and fibrolytic agents, anti-inflammatory agents, antibodies, alone or in combination or with nanoparticles including lipids, gold, carbon, that are deliverable in the form of a solution.

18. 2. The multi-function balloon catheter (10) of claim 1, wherein the first balloon (13) is further configured to carry the stent (35) deployable at the selected section or the lesion origin (32) by inflating the first balloon (13).

19. 2. The multi-function balloon catheter (10) of claim 1, wherein the catheter body (12) includes multiple lumens, each lumen connected to a dedicated port (25) of a multi-port hub (22).

20. 2. The multi-function balloon catheter (10) of claim 1, wherein the first balloon (13) is sized to substantially cover a length of the selected section or lesion (32) of the blood vessel (30), while the second balloon (15) and the third balloon (14) remain aligned within or at a proximal edge (32a) and within or at a distal edge (32b) of the selected section or lesion (32) of the blood vessel (32).

21. 21. The multi-function balloon catheter (10) of claim 20, wherein the first balloon (13) is sized to substantially cover a length of the selected section or lesion (32) of the blood vessel (30), while the second balloon (15) and the third balloon (14) remain aligned away from the proximal and distal edges (32a) and (32b) of the selected section or lesion (32) of the blood vessel (32) toward a healthier portion of the blood vessel (30).

22. 2. The multi-function balloon catheter (10) of claim 1, further comprising one or more electrodes (72, 74, 96) attached or located proximate to the first portion (12d) of the catheter body (12) and powered by a power source (80).

23. 23. The multi-function balloon catheter (10) of claim 22, wherein the power source (80) delivers a flow of pulses to the one or more electrodes (72, 74, 96) to create a flow of waves or vibrations (95) within the first balloon (13) that moves toward the selected or diseased section (32) of the blood vessel (30).

24. 24. The multi-function balloon catheter (10) of claim 23, wherein the wave or pulse flow produces a continuous vibration or perforation effect on the diseased section (32) of the blood vessel (30).

25. The wave motion includes at least Mechanical waves, including sound waves, ultrasound waves or pressure waves, that can propagate through air, fluids and solids; or 24. The multi-function balloon catheter (10) of claim 23, comprising an electromagnetic wave capable of propagating through air, fluid, solid material, or vacuum.

26. A multi-function balloon catheter (10) for use in treating a lesion occurring near the distal end of an artery or vein, comprising: an elongate catheter body (12) having a tip (12a), a proximal end (12b) and a distal end (12c); a first balloon (13) having a predetermined shape and size mounted on the first portion (12d) of the elongated catheter body (12); a second balloon (15) having a predetermined shape and size mounted on the second portion (12e) of the catheter body (12) at the proximal end (12b); the first balloon (13), the second balloon (15) are selectively inflated or deflated to perform at least one of the following procedures: widening a selected section of a blood vessel (30) or a lesion site (32) to allow improved blood flow therethrough; delivering one or more therapeutic agents (60) into the selected section of the blood vessel (30); and deploying a stent (35) into the selected section of the blood vessel (30) or the lesion site (32) to ensure that the selected section of the blood vessel (30) remains open once the first balloon (13) of the balloon catheter (10) is inflated; when the second balloon (15) is inflated within the selected section (32) of the blood vessel (30), it forms a partial seal that allows a continued partial blood supply distally at the end of the blood vessel (30); A multi-function balloon catheter (10) in which, when the first balloon (13) is inflated to widen the selected section or lesion (32) of the blood vessel (30), it presses against and at least partially contacts the inside (13c, 13d) of the selected section or selected lesion (32) of the blood vessel (30).

27. 27. The multi-function balloon catheter (10) of claim 26, further comprising one or more electrodes (72, 74, 96) attached or located proximate to the first portion (12d) of the catheter body (12) and powered by a power source (80).

28. 28. The multi-function balloon catheter (10) of claim 27, wherein the power source (80) delivers a flow of pulses to the one or more electrodes (72, 74, 96) to create a flow of waves or vibrations (95) within the first balloon (13) that moves toward the selected or diseased section (32) of the blood vessel (30).

29. The multi-function balloon catheter (10) of claim 28, wherein the wave flow produces a continuous vibration or perforation effect on the diseased section (32) of the blood vessel (30) and includes at least mechanical waves including sound waves or ultrasonic waves or pressure waves capable of propagating through air, fluids, and solids, or electromagnetic waves capable of propagating through air, fluids, solid materials, or vacuum. and at least one port (18, 17) located on either or both sides of the first balloon (13) for delivering and extracting one or more therapeutic agents (60) within the selected section (32) of the blood vessel (30) during or after a medical procedure. The multi-function balloon catheter (10) of claim 26, comprising:

31. A multi-function balloon catheter (10) for use in treating the microvasculature, comprising: an elongate catheter body (12) having a tip (12a), a proximal end (12b) and a distal end (12c); a balloon (15) having a predetermined shape and size mounted on a portion (12e) of the catheter body (12) at an end (12b); the balloon (15) is selectively inflated or deflated to perform at least one of the following procedures: widening a selected section of a blood vessel (30) or a lesion site (32) to allow improved blood flow therethrough; delivering one or more therapeutic agents (60) into the selected section of the blood vessel (30); and deploying a stent (35) into the selected section of the blood vessel (30) or the lesion site (32) to ensure that the selected section of the blood vessel (30) remains open once the balloon (15) of the balloon catheter (10) is inflated; A multi-function balloon catheter (10) in which the balloon (15) presses against and at least partially contacts the inside (13c, 13d) of the selected section or selected lesion (32) of the blood vessel (30) when inflated to open the selected section or lesion (32) of the blood vessel (30) and deliver the one or more therapeutic agents (60) into the selected section (32) of the blood vessel (30).

32. 32. The multi-function balloon catheter (10) of claim 31, further comprising one or more electrodes (72, 74, 96) attached or located proximate to the portion (12e) of the catheter body (12) and powered by a power source (80).

33. 33. The multi-function balloon catheter (10) of claim 32, wherein the power source (80) delivers a flow of pulses to the one or more electrodes (72, 74, 96) to create a flow of waves or vibrations (95) that travel toward the selected or diseased section (32) of the blood vessel (30).

34. The multi-function balloon catheter (10) of claim 33, wherein the wave flow produces a continuous vibration or perforation effect on the diseased section (32) of the blood vessel (30) and includes at least mechanical waves including sound waves or ultrasonic waves or pressure waves capable of propagating through air, fluids, and solids, or electromagnetic waves capable of propagating through air, fluids, solid materials, or vacuum.

35. The multifunction balloon catheter (10) of claim 31, further comprising at least one port (18, 17) located on the catheter body (12) for delivering and extracting one or more therapeutic agents (60) within the selected section (32) of the blood vessel (30) during or after a medical procedure.

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