ARTERIAL BALLOON WITH VARIABLE PRESSURES

Abstract

Provided is a balloon with multiple small segments (balloons) fused to each other along the shaft of the balloon. Each segment has a different pressure profile. Each segment has a separate outlet (slot) used for its inflation with the required pressure according to the tightness and calcification of the lesion of the arterial wall. Each segment can be inflated with different pressures and the apposition of the overlying stent can be confirmed without the need for another non compliant balloon which carry many complications and add extra cost.

Claims

1. A catheter for performing vascular angioplasty comprising: an inflating balloon catheter having multiple balloons, wherein the multiple balloons include at least three balloon, wherein each balloon of the multiple balloons adjoin another balloon without overlapping cavities, and wherein each said balloon of the multiple balloons has the ability to expand individually and separately such that each balloon of the multiple balloons can be inflated alone; wherein the inflating balloon catheter is configured for mounting of a stent and at least one balloon of the multiple balloons is configured for delivering the stent, wherein the inflating balloon catheter has a catheter shaft with a cavity for a guide wire; wherein in the catheter shaft there is a second cavity used to inflate at least one balloon of the multiple balloons; wherein at an end of the catheter shaft, there is a connection for an inflator; wherein separate openings within the catheter shaft are provided to inflate each balloon of the multiple balloons separately; wherein a sliding column is provided within the catheter shaft for inflation of at least one balloon of the multiple balloons; and wherein the sliding column carries multiple protrusions configured to close openings of the multiple balloons during inflation.

2. The catheter of claim 1, wherein each balloon of the multiple balloons is formed of a single, continuous tube of polymer material and wherein each balloon of the multiple balloons is configured to accept a mount of a stent.

3. The catheter of claim 1, wherein the separate openings are present at the end of the catheter shaft at regular intervals and each respective opening of the separate openings connects to a balloon of the multiple balloons facing the respective opening.

4. The catheter of claim 1, wherein the sliding column controls the openings of the multiple balloons.

5. The catheter of claim 1, wherein the sliding column controls the openings of each balloon of the multiple balloons independently.

6. The catheter of claim 1, wherein the connection for the inflator is used for all balloons of the multiple balloons.

7. The catheter of claim 1, further comprising labels on the catheter shaft configured for guiding the movement of the sliding column for inflation of respective balloons of the multiple balloons.

8. A method for performing dilation of a target vessel having a target lesion with different diameters or different calcifications along its length, comprising: providing the catheter of claim 1; placing the catheter such that at least one balloon of the multiple balloons is inside the target vessel opposite the target lesion; controlling the sliding column; and controlling an inflating pressure by the inflator.

Description

BRIEF DESCRIPTION

[0036] Some of the embodiments will be described in detail, with references to the following Figures, wherein like designations denote like members, wherein:

[0037] FIG. 1 depicts a balloon according to embodiments of the invention in which only a third balloon is filled;

[0038] FIG. 2 depicts the balloon according to embodiments of the invention in which only a second balloon is filled;

[0039] FIG. 3 depicts the balloon according to embodiments of the invention in which only a first balloon is filled;

[0040] FIG. 4 depicts the balloon according to embodiments of the invention in which the first balloon and the third balloon are filled;

[0041] FIG. 5 depicts the balloon according to embodiments of the invention in which the second balloon and the third balloon are filled;

[0042] FIG. 6 depicts the balloon according to embodiments of the invention in which the first balloon and the second balloon are filled; and

[0043] FIG. 7 depicts the balloon according to embodiments of the invention in which all of the first balloon, second balloon, and the third balloon are filled.

DETAILED DESCRIPTION

[0044] Referring to the Figures, the following elements are shown: [0045] 1—The first balloon; [0046] 2. Second balloon; [0047] 3. The third balloon; [0048] 4 The sliding column (arm) of inflation which is connected to the endflator; [0049] 5. First (distal) protrusion; [0050] 6. Second (middle) protrusion (at a distance X from the first one (no 5)); [0051] 7. Third (distal) protrusion (at a distance from the middle projection (no 6) equal to 1/2×); [0052] 8. Markers and locks to on the external surface of the sliding column (arm) to lock the movement of the sliding column when the desired distance is reached; and [0053] 9. Endflator [0054] The balloon usually consists of a column with a cavity that allows for a very thin guide wire (for example, 0.014 inches). [0055] In the arm there is another cavity used to inflate the balloon, which is usually used with saline solution (not air). [0056] At the end of the balloon arm, there is an inflator.

[0057] The balloon consists of a group of 3-5 small balloons adjoining each other, but their cavities do not overlap. Each balloon has a length range (5-10 mm) and diameter range (2-4.5 mm) in the embodiment used in coronary angioplasty. [0058] In the embodiment of the current invention used in peripheral angioplasty, each balloon should have a length range (5-20 mm) and diameter range (5-15 mm). [0059] Each small balloon has the ability to expand according to the amount of pressure used for its inflation, so that it expands alone without the other adjacent parts (balloons). [0060] The arm at the end of the balloon has several adjacent openings at regular intervals, each of which corresponds to the balloon facing it.

[0061] (These openings are aligned along single inflation path that makes embodiments of this invention different from, for example, “Angle inflatable composite balloon & method” (US20130238038A1) discussed above, in which the inflation of each balloon is done through different path so that each balloon should be inflated separately at a time. [0062] The front of the arm (column) cavity where the balloon is inflated on a thin metal wire (control wire) has at its end 3 protrusions on regular interval distance except for the third which is on double the interval distance.

[0063] (This feature is not present in any of the previous arts).

Method of Operation

[0064] 1—When inflating the balloon, 2 protrusions will be closing the opposite balloons at a time, so that only one balloon will be inflated. When inflating 2 balloons, the column is retracted so that only one protrusion closes the opposing balloon. On inflating the 3 parts, the column is retracted in a way that all the protrusions are away from the opposing openings. Therefore one can inflate whatever balloons are needed at a time with a single inflator.

[0065] (This feature is not present in any previous art. For example, The Angle inflatable composite balloon & method” (US20130238038A1) discussed above requires each balloon to be inflated separately at a time. Therefore the operator needs multiple inflators for inflation all balloons together at a time).

[0066] 2. The inflating pressure of each balloon is controlled by the endflator (as is the case in all currently used balloons), but each small balloon is inflated according to different needs and pressure.

[0067] 3. When the balloon is blown up (or the stent is installed), the balloons are completely inflated by pulling the control wire as described above so that all the openings are exposed and it is easy to inflate the balloons together.

[0068] 4. Inflation of both the proximal and distal balloons can have an anchoring effect preventing sliding of the balloon over the calcified lesion while inflation the middle balloon(s).

Method of Exploitation of the Possible Embodiments

[0069] 1—Balloon of dilatation of coronary arteries (PTCA balloon): in this case each balloon has a length range (5-10 mm) and diameter range (2-4.5 mm) 2—Balloon dilatation of the peripheral arteries: in this case in peripheral angioplasty, each balloon should have a length range (5-20 mm) and diameter range (5-15 mm).

[0070] 3—Stents could be mounted on the balloon to be implanted in the coronary or peripheral arteries.

[0071] Although the present invention has been disclosed in the form of preferred embodiments and variations thereon, it will be understood that numerous additional modifications and variations could be made thereto without departing from the scope of the invention.

[0072] For the sake of clarity, it is to be understood that the use of “a” or “an” throughout this application does not exclude a plurality, and “comprising” does not exclude other steps or elements. The mention of a “unit” or a “module” does not preclude the use of more than one unit or module.