Patent Application
20240416088
The invention relates to a balloon catheter system, in particular a thrombus catheter, preferably a recirculating transferring dilatation catheter system, used in the treatment and cleaning of arteries, veins, other circulatory channels in the circulatory system of humans and animals, digestion, dilatation, fluid delivery, medication delivery, plaque, stenosis, thrombus and other extra anatomical, extra biological structures and formations.
Catheter devices of the balloon type, and more particularly catheter devices comprising multiple inflatable means carried by the catheters, are widely used in treatment concepts or methods for the site-specific local delivery of agents to biological spaces in medical procedures. In particular, such catheter systems, preferably with at least one radial opening located between at least a pair of inflatable means, may be used in methods for site-specific or local delivery of agents into blood vessels (including the blood vessel lumen and the vessel wall) for treatment of said blood vessels and/or other organ systems, as well as methods of visualizing the lumen of said blood vessels and/or other organ systems.
Arterial obstruction and constriction, venous obstruction, stenosis and venous insufficiency, narrowing in the excretory system, are defined as complaints caused by extra anatomical and extra biological conditions. Arterial stenosis or occlusion is an artery disease. These diseases occur throughout the neck (carotid), arm (subclavien, axillary, brachial, radial), abdominal vessels (Abdominal aorta, common iliac, external iliac, internal iliac) and leg vessels (femoral artery, Sfa, profunda or DFA, popliteal artery, anterior tibial artery, peroneal artery, posterior tibial artery). Since the blood flow is slowed or completely interrupted beyond the area where the congestion or narrowing occurs in these diseases that occur in the arteries, it can not be fed sufficiently after the occlusion, causing resting pain, severe pain while walking, discoloration of the skin, and finally loss of limb. Venous occlusion, thrombus or insufficiency is a venous disease. The most important venous occlusion, thrombus and insufficiency occur in the veins in the leg and abdomen. In addition, venous occlusion and thrombus are also seen in the vein vessels of the arm. In case of occlusion, thrombus or insufficiency, there is pain, swelling and discoloration of the skin in the relevant area, but it can result in severe paralysis or death by causing stroke or pulmonary obstruction in the brain due to clotting in the future.
Typical treatments performed nowadays for artery and vein vascular occlusions, thrombus formation or narrowing are: By-Pass surgery is in the form of PTA balloon dilation, atherectomy, aspiration, bare or covered stenting and/or dilatation with medication loaded balloons in endovascular treatments, allowing the coated medication to release in the lesioned area.
A very common treatment known for the aforementioned diseases is medication transfer to the diseased area with a medication-coated balloon. The patient is placed on the imaging device (angio and fluoroscopy) table in the imaging laboratory. Necessary antisepsis is applied to the relevant area to be introduced. With the Seldinger technique, intravascular cannulation is provided by introducing into the vessel, in particular arteri or vein, and placing the introducer sheath. All subsequent operations to be performed and all devices to be used are sent through this sheath. A contrast agent that helps diagnostic imaging is injected into the vessel through the sheath or with the help of a catheter, and the vein image is provided under fluoroscopy. In this way, the occlusion, stenosis, thrombus, plaques, calcification and/or the diseased area in the vessel are diagnosed and determined. This area is passaged with the help of guidewires and/or catheters and intravascular full cannulation is provided. With the guidewire in the vessel, a PTA balloon catheter is sent over it, inflating with ATM (atmospheric) pressure suitable for the effect of the balloon for pre-dilatation, the relevant area is expanded and the balloon is deflated after waiting for the desired time. The same process is repeated if this ex-pansion is not sufficient. When the opening of the relevant area in the vessel is deemed sufficient, a balloon catheter loaded with paclitaxel, sirolimus, everolimusor similar medication is sent and the diseased area is inflated for the time specified in the technical table, allowing the medication coated on the balloon to pass to the vessel surface.
This medication delivery process aims at minimizing re-occlusion condition. In case the diseased area within the vessel cannot be reached the desired width despite all these procedures, With the help of various atherectomy devices, the plaque load in the vessel is tried to be cleared, or the optimum width within the vessel is tried to be achieved by placing a loaded stent or a self-expandable stent on the balloon in order to provide the desired diameter without atherectomy.
Some main issues in these concepts may occur during the medication-coated balloon application, which is among these treatment steps. The medication loaded on the balloon with the help of various chemicals is subjected to various processes while being sent into the vessel. While the balloon is removed from the sterile package and loaded to the guide wire, hand and fluid contact occurs on the balloon surface, while it is sent to the target area over the guidewire, it passes through a tight introducer sheath filled with blood or fluid, and a certain surface of the balloon is completely in contact and interacts with blood during the time it goes to the target area. In all these steps, the medication covered on the balloon suffers serious losses due to these interactions and cannot be transferred to the vascular surface in targeted doses and amounts. Medication of the part of the balloon surface may completely disappear. As the current technology is insufficient some medication types with certain characteristics can not be used to cover balloons.
There are some catheters created as a solution to the problems mentioned above. The general purpose of the catheters in question is to compress the problematic area inside the vessel with balloons inflated from both ends, to clean the area with the aspiration process, and then to transfer the medication administered through the lumens to the relevant area.
European patent application No. EP2 497 524 relates to a multi-balloon catheter for medication delivery into veins. It discloses a multi-balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue, comprising a first balloon, a second balloon, and a catheter having a third balloon positioned between said first and second balloon. It has a fluid supply thereto to create a chamber on the catheter shaft between said first and second balloon, with fluid providing to inflate the first and second balloons mentioned. The catheter mentioned has a fluid path between the first balloon and the second balloon through which it can deliver the therapeutic and/or diagnostic agent, and a fluid source that increases the fluid pressure into the chamber by providing fluid to the said third balloon, and aims to transfer the administered medication into the tissue by inflating the middle balloon.
U.S. Pat. No. 6,485,500 discloses an embolism protection system designed to isolate a part of a blood vessel and prevent embolism from migrating into the rest of the vascular system. It comprises a distal blocking balloon catheter with pores at the proximal end of the catheter and an inflation feed fluid in fluid connection with distal and proximal barrier inflatable balloons. Proximal to the blocking balloon the catheter is adapted to be positioned in the vascular system and to provide inflation flow by rapidly guiding the inflation fluid under pressure from said pores and emboli to the emboli in the isolated part of the blood vessels towards the exit ports of the proximal blocking balloon catheter and close to the fluid communication lumen of the proximal blocking balloon catheter.
WO 2010/062778 A2 discloses a catheter comprising multiple inflatable balloons, in which the center balloon positioned between a proximal and a distal balloon is provided in order to minimize the surrounding volume within the blood vessel. When the medication is delivered via skyve ports positioned on the catheter shaft between the proximal and distal balloon, the center balloon may be inflated to minimize said volume, thereby improving the efficiency of medication delivery.
In WO 2019/027380 A1, a catheter system comprising multiple inflatable balloons is disclosed in which the center balloon is provided with a porous skin, thereby enabling the use of the center balloon as delivery port for the agent or medication.
In all these systems, the catheter system comprises a catheter shaft with a number of lumens each of which provides a media channel to either one of the balloons or to orifices positioned on the catheter shaft in the medication delivery segment. Accordingly, by means of the mutli-lumen catheter shaft, dilatation, aspiration, fluid, and/or fluid-medication may be delivered to the respective areas on the catheter shaft for their respective purposes.
It is now an objective of the present invention to provide a catheter system of the type identified above having a particularly simple, easily usable, cost efficient design allowing for low production cost while providing high reliability nevertheless. In particular, the invention aims at having a particularly effective use during the treatment. the patient should be given the best, safest and fastest treatment while at the same time the system should be user friendly for the doctors. The goal is to first of all offer a catheter system with multiple, preferably unlimited, options of medications compared to a now limited list of options of medication.
In accordance with the invention, this objective is achieved by providing a catheter shaft for the catheter system, said catheter shaft being assembled from a number of tubes which are bundled together by adhesive force to form the shaft body. In the concept of the present invention, bundling or bonding by “adhesive force” is supposed to mean any technology of substance-to substance bonding of components, such as by adhesive, glue, soldering, welding, thin coating, vulcanizing or the like. Preferably, bonding is effected by medical grade adhesive.
Preferred embodiments of the invention are specified in the dependent claims.
The invention is based upon the consideration that minimization of production costs may be achieved by keeping as many components particularly simple as possible. Under this aspect, in the catheter systems as known from the prior art, the multi-lumen catheter shaft is recognized as a relatively complex, costly component that under the consideration of the present invention should be simplified. In particular, for the multi-lumen catheter shaft, independence and reliable separation of each lumen against each other is important for proper functionality of the system since the respective media transported via the lumen must be kept separate from each other in order to enable reliable and efficient treatment.
In the existing systems, the catheter shaft is manufactured by extrusion. This, however, requires complex treatment since a number of up to five lumens must be integrally formed into the extruded shaft body. In order to simplify production and minimize cost, it is therefore an aspect of the present invention to use a number of originally separate tubes to provide for the lumens, and assemble them together into the actual catheter shaft by adhesive means, in particular by welding or gluing, or any other appropriate technique. It can be combined with coating or an extra external tubing. Welding may vary by bounding.
In an advantageous embodiment of the invention, three tubes are assembled to form the catheter shaft. Preferably and in order to achieve a particularly compact desing, the individual tubes should be arranged such that, as seen in cross section, their respective centers are the corners of a triangle, preferably of an equilateral triangle. In yet another, alternative or additional preferred embodiment, the tubes forming the catheter shaft are surrounded by an outer coating or wall, encapsulating the set of assembled tubes.
Preferably, one, some, or all of the tubes each providing a single lumen comprises a multi-layered tube wall. In this preferred embodiment, the wall of the respective tube is a multi-layer structure, in which several layers with different functionality are provided. Preferably, at least one of said layers, e. g. a middle layer, is made from reinforced, e. g. braided, material such as braided PTFE, HDPE, or PFA, thereby providing enhanced mechanical strength, durability, and resistance. In contrast, another of said layers, e. g. an inner layer facing towards the lumen and thereby potentially contacting the medium to be transferred, may be made of material such as PTFE, HDPE, or PFA with low frictional resistance. Yet another layer, e. g. an outer layer surrounding the other layers, may be made of materials such as PTFE or PET with low frictional resistance and adding rigidity to the tube system.
A preferred triple tube design can be made with two different tube sizes, two occlusion balloons with the same characteristics, a perforated middle balloon and standard connectors available in the market, in particular standard or specially designed handheld Y connectors.
In another aspect of the invention, herein regarded as an independent invention of its own value or in combination with the aspects disclosed above, the central balloon of the catheter system is designed as a porous balloon that may be used as a delivery port for the agent or medication into the blood system included between the distal and proximal occluding balloons. In accordance with this aspect of the invention, the outer wall of the central balloon may be equipped with holes in various sequencing designs and have different hole sizes to transfer any drug and/or liquid to the diseased area in the vessel. For example, the arrangement of the holes can be straight, spiral, complex or in any other geometric shape. The diameter of the holes in a preferred embodiment may range from 1 micron to 50 microns.
The perforated balloon in the middle in a preferred embodiment can be produced smaller than the diameter of the treated vessel or suitable for the vessel diameter. This production logic will ensure that the drug and/or liquid to be sent into the vein will be applied 360 degrees on the inner surface of the vein in the most effective way. The fact that the perforated balloon in the middle is smaller than the vessel diameter will prevent a barotrauma, to which the vessel is exposed. Because, in a kind of dilatation procedure in the vein creates a trauma in the vein and the vein gives a vasospasm reaction to it. This reaction can cause acute occlusion even if a successful operation is performed on an already occluded or diseased vessel.
In yet another independent aspect of the invention, herein also regarded as an independent invention of its own value, the catheter system is equipped with a circulation system for the agent. This re-circulation system in principle works according to the following steps:
As another option, the second extension tube may be connected to a circular motor pump. The tube is connected to the rotating part of the motor pump which provides re-circulation by the rotation which is provided, similar to a dialysis device.
According to the appropriate method in dialysis treatment, the second extension tube is connected to the circular motor section. The appropriate engine rotation speed is determined in the tests. According to the determined rotation speed, the motor pump provides effective recirculation of the drug and/or liquid in the localized area in the vessel.
The main advantages achieved with the invention are that the multi-lumen tube design is very simply and economic, and it has great advantages in terms of shaft, production, production expenses (machine and equipment, components, number of employees), R & D expenses (prototyping, preliminary functional tests, clinical studies). The shaft can be formed by placing several tubes of same diameter and same properties on top of each other by applying medical grade adhesive and thin heat shrink coating on it. Various individual tubes can be the same original tube cut in different lengths to form a catheter shaft. According to the performance evaluation, these tubes can be selected from materials with different parameters with different wall thicknesses or reinforced to increase push ability and kink resistance. Desired features can be added to single lumen tubing. As a major advantage, operation cost and time will be reduced.
If necessary, balloon deflating and inflation times can be adjusted or improved by adjusting free cross section of the tubing in the occlusion balloon tube line. During the production stages, wires (mandrel) may be put into the pipes, providing comfortable working opportunity. During all production processes tubings can stand rigid and lumen collapsation does not occur, whereas pushability and kink resistance are increased.
In terms of producing the product, it provides great convenience compared to conventional multi-lumen shaft designs based upon extrusion processes. Very precise holes or channels must be drilled on the multi-lumen shaft for inflating and deflating the occlusion balloons and the perforated balloon, drug delivery and aspiration. In the multi-tube design according to the present invention, there will be no need to drill holes on the shaft; it is only necessary to perforate a hole for the first occlusion balloon. In the triple pipe design, the liquids are sent independently of each other in a cylindrical geometry, which is efficient and more advantageous in terms of inflation and deflation times. The inner and outer surfaces of the independent pipes in a preferred embodiment can be coated with materials with low friction resistance.
In particular, the design of the catheter shaft according to the invention is less costly and allows for more effective operations as compared to previously known systems. In particular, the new catheter design, created by combining separate tubings according to the multilumen catheter shaft, provides wider interior lumens and shortens the inflation and deflation times of balloons, thereby increasing pushability. Thanks to these larger interior lumens the drugs and/or liquids are delivered to the diseased area in the most effective way and recirculation is carried out.
Another important feature of the invention is that it can be re-used in the same patient. In peripheral artery or vein diseases, the lesions may be very long and bilateral. In this case, it may be necessary to use more of the drug-coated balloons. This increases the cost of the procedure and also requires a continuous catheter exchange in the diseased vessel.
During these changes, the guidewire, guiding sheat, and/or balloon catheter can come into contact with the vessel surface. This contact may cause vaso spasm or a different complication that may occur in the vessel. This invention enables treatment with minimal catheter changes in the same vessel. Thanks to its perforated balloon design, the catheter shaft enables effective drug transferring with less lumen in within a smaller tube, applying unlimited drug options and recirculation with addition of any technology provided in the future.
Exemplary embodiments of the present invention are explained in further detail by reference to the drawings. In the drawings, it is shown in:
Identical parts are identified by identical reference numerals in all FIGS.
The catheter system 1 as shown in
The catheter system 1 comprises multiple inflatable means located on a common catheter shaft 2: a distal inflatable balloon 4 located in the vicinity of the distal end 6 of the catheter shaft 2, a proximal inflatable balloon 8 located on the catheter shaft 2 at a distance from the distal balloon 4, and a center inflatable balloon 10 located on the catheter shaft 2 between the distal balloon 4 and the proximal balloon 8. The distal balloon 4 and the proximal balloon 8 are designed as occluding balloons; when inflated, they will expand until they contact the inner surface of the respective blood vessel and seal it off, thereby providing a sealed, isolated volume in the blood vessel in the segment between them. The center balloon 10, in contrast, is designed as treatment balloon.
The catheter shaft 2 of the catheter system 1 is designed as a multi-lumen shaft 2 and at its proximal end 12 is connected to a multi-lumen hub 14 that on its inlet side is connected to a number of connectors 16, in the embodiment shown female Luer connectors 16, via a number of the individual tubings 18. Depending on the individual design and layout of the end-part of the catheter system 1, the tubings 18 may also be interconnected by a number of Y-connectors 20 or branch-offs, as shown in
In the embodiment as shown, the distal balloon 4 and the proximal balloon 8 are pre-welded on the catheter shaft 2, enabling them to cover both ends of a lesion or target area.
In this pre-treatment procedure, the PTA balloon or treatment balloon may, as shown, be used as a mechanical device; in this case inflation of the treatment balloon will exert mechanical force on the lesion 32, thereby potentially shrinking it. In the subsequent treatment phase with the catheter system 1 of the present invention, the balloon segment comprising balloons 4, 8, and 10 may be introduced into the lesioned vessel segment. In this treatment procedure, the center balloon 10 or treatment balloon may, as shown, be used as a mechanical device; in this case inflation of the treatment balloon, in addition to potentially exerting mechanical force on the lesion 32, will reduce the free volume within the encapsulated volume between the occluding balloons 4, 8. In this status, aspiration and/or the agent or medication may be delivered to the encapsulated, minimized volume via the orifice 22; due to minimization of the free volume in this area, distribution of the medication in the blood and/or adherence of the drug on the vessel surface will be much more efficient, which may be highly beneficial in case of delicate or expensive medication.
In one inventive aspect of the present disclosure, however, the treatment balloon 10 as such is designed as delivering means for delivering agent, medication, or other media directly into the volume within the blood vessel 30. For this purpose, as can be seen in
In a preferred embodiment shown, the perforated balloon 10 in the middle is smaller than the vessel diameter in order to minimize the risk of barotrauma to which the vessel is exposed. In particular, any kind of dilatation procedure performed in the vein creates a trauma in the vein and the vein gives a vasospasm reaction to it. This reaction can cause acute occlusion even if a successful operation is performed on an already occluded or diseased vessel. Another important feature of the invention is that it can be reused in the same patient. In peripheral artery or vein diseases, the lesions may be very long and bilateral. In this case, it may be necessary to use more of the drug-coated balloons. This increases the cost of the procedure and also requires a continuous catheter change in the diseased vessel. During these changes, Guide wire, guiding sheath, balloon catheter come into contact with the vessel surface. This contact may cause vaso spasm or a complication that may occur in the vessel. The present invention enables treatment with minimal catheter exchange in the same vessel. Thanks to its perforated balloon design, the catheter shaft enables effective drug transfer with less lumen in a smaller tube, applying unlimited drug options and recirculation with the possibilities provided by the technology in the future.
In other words, for the treatment as shown, the distal and proximal balloons 4, 8 are inflated to close off the area to be treated such that fluid, fluid-medication, agent, or the like, may be delivered, in particular by applying pressure using hydrodynamic principles, aspiration, circulation. The fluid or blood remaining in the area of the aspiration pores 22 may be simultaneously aspirated in the area between the two balloons 4, 8 (phase shown in
The porous balloon 10 in this phase is shown in more detail in longitudinal section in
After delivery of the drug or medication, in a subsequent treatment phase shown in
After treatment, all balloons 4, 8, 10 may be deflated again, and the catheter 1 is removed from the blood vessel 30 (
In order to safely and reliably provide the functions described above, proper and controlled supply and delivery of various media to the respective parts is necessary and important: fluid and/or medication must be delivered to the balloons 4, 8, 10 and to the aspiration pore 22. In order to provide for this, in one aspect of the present invention the catheter shaft 2 is designed as a multi-lumen shaft 2 in the way of a multi-pipe or multi-tube design, comprising an occlusion balloons lumen 42, intended to deliver medium to the occlusion balloons 4, 8, a treatment balloon lumen 44, intended to deliver medium to the center balloon 10, an aspiration lumen 46, intended to deliver medium to the aspiration pore 22, and a guidewire lumen 48 for the guidewire 34. At the proximal end 12 of the catheter shaft 2, they are all connected to the multi-lumen hub 14, which in turn is connected to the respective tubings 18 with the connectors 16 for attachment to appropriate medium reservoirs or delivery devices such as pumps etc. At their distals ends, each lumen 42, 44, 46, 48 is connected to the respective balloon 4, 8, 10 or aspiration pore 22, respectively, thereby forming a treatment balloon tubing line, a guidewire tubing line, a distal and proximal balloon inflation, inflation & deflation tubing line, and an aspiration tubing line, all of which are integrated into the multi-lumen catheter shaft 2. Consequently, in the embodiment shown the multi-lumen catheter shaft 2, which is configured with a valve distal to the guidewire line, is designed as a four-lumen catheter shaft 2, which is considered to be highly efficient and therefore preferred.
In one inventive aspect of the present invention, the catheter system 1 features a particularly simple, cost efficient design allowing for low production cost while providing high reliability for medium supply to the treatment components nevertheless. In order to achieve this objective the catheter shaft 2 is assembled from a number of individual tubes 50 which are bundled together by medical grade adhesive to form the body of catheter shaft 2.
This particular design of the catheter shaft 2 becomes evident from the cross sectional view in
With respect to exact dimensioning, various alternatives are possible in view of potentially varying requirements. Typically, for catheter systems 1 of the type discussed here, dimensions such as diameters are measured in “French units (Fr)”, where one French equals 0.33 mm. Catheter shafts to be used in coronary arteries are preferably between 3-5 Fr. in diameter, most preferably around 3 Fr. In contrast, catheter shafts to be used in peripheral vessels are preferably between 5-8 Fr. in diameter, most preferably around 5 or 6 Fr. Depending on the exact requirements given by the treatment, for the catheter shaft 2 the dimensions (diameters) are chosen appropriately. In
In the embodiment of
In the alternative embodiment shown in cross section in
In all cases, sufficient room with respect to the introducer sheath 60 is provided, thereby minimizing friction effects during insertion. Insertion of the multi-lumen catheter shaft 2 into the introducer sheath 60 is shown in cross sectional view in
The tubes 50 forming the catheter shaft 2 in one embodiment are surrounded by an outer coating or wall 56, encapsulating the set of assembled tubes 50.
The individual tubes 50, each providing a single lumen 42, 44, 46, 48, are specifically designed for the specific requirements derived from the intended use in a blood vessel catheter system 1, i. e. regarding rigidity, robustness, sealing properties, biomedical compatibility, etc. In view of these requirements, each tube 50 in the embodiment shown comprises a multi-layered tube wall 58, as shown in the cross sectional view in
In another inventive embodiment shown in
For re-circulation, the catheter shaft 2 is sent to the target area detected in the vessel 30. Then, the distal and proximal balloons 4, 8 are inflated by the inflator or similar device 88 connected to the first extension line 80 connected to the hub. As a consequence of the inflation, the area of the perforated center balloon 10 comprising the lesion 32 in the blood vessel 30 is isolated. Remaining blood in the isolated area can the be aspirated using the second extension line 90. The inflator device 88 or a separate inflation device 108 is then connected to the third extension line 100 in order to inflate the perforated center balloon 10 and/or transfer the drug and/or liquid to the target area. The drug and/or liquid delivered with a controlled pressure begins to further inflate the perforated balloon 10. When the pressure applied reaches a certain level, the drug and/or liquid starts to fill the isolated area formed by the distal and proximal balloons 4, 8 by further inflation through the pores 40 of the perforated balloon 10.
When the filling reaches the appropriate pressure within the second extension line 90 to which it is connected, a retrograde flow occurs within the aspiration channel in between the distal balloon 4 and the perforated center balloon 10. The flow is maintained until it exits the proximal end 114 of the extension tube 94 of the second extension line 90. Afterwards, the proximal end 114 of the extension tube 94 is inserted into the Y-connector 106 connected to the third extension line 100 with the one-way valve 112 that allows a retrograde flow. After this connection, the inflator device 108 connected to the third extension line 100 ensures the recirculation thanks to the pressure created in a controlled manner. Another option may be to connect the second extension line 90 to a circular motor pump. The tube is connected with the rotating part of the motor pump which provides re-circulation by the rotation which is provided, similar to the dialysis device.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21201731.3 | Oct 2021 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/078021 | 10/10/2022 | WO |
