| US4763654A | 1988-08-16 | |||
| US20130238038A1 | 2013-09-12 | |||
| EP0266957A2 | 1988-05-11 |
| 5-Claims New items to protect: 1- Multiple balloons (5-10 mm long each) with diameter range (2- 4.5 mm) fused together in one inflating balloon. Inflation of balloons is done through column or axis (arm) of inflation that contains separate openings or slots to inflate each balloon separately. The column contains a wire carrying multiple protrusions (projections) used to close the openings of balloons according to the operator’s choice. 2 - The existence of separate slots to inflate each balloon separately (refer to n°l). 3 - The existence of a sliding wire (column) to control the inflation openings (refer to n°l). 4 - The existence of different projections in the column (refer to n°3) to close the openings of the balloons in an optional manner as needed so that you can inflate one, two or the three balloons at a time (refer to n° l). 5 - The existence of a connection at the end of the sliding column connected to one inflation device (endflator) used for all the balloons, which reduces the cost and space used during the operation. |
| AMENDED CLAIMS received by the International Bureau on 17 July 2020 (17.07.2020) Claims [Claim 1] A catheter for performing vascular angioplasty comprising : -Multiple balloons (3-5 balloons) 5-10 mm long each with diameter range (2- 4.5 mm) fused together ultimately in one inflating balloon catheter. The balloons are adjoining each other, but their cavities do not overlap. Each one of the said balloons has the ability to expand indi vidually and separately according to the amount of pressure used for its inflation, so that it could be inflated alone without the other adjacent parts (balloons). - The said balloon could work alone for angioplasty dilatation and could accept the mounting of a stent over it, therefore the said balloon could be used in this case for delivering the stent. - A catheter shaft has a cavity (lumen) that allows for a very thin guide wire (0.014 inches). In the said shaft there is another cavity (lumen) used to inflate the balloon, which is usually done with saline solution (not air). At the end of the balloon shaft, there is a connection for an inflator. - Separate openings or slots within the said shaft to inflate each balloon separately. -A sliding column or axis (arm) within the said catheter shaft by which inflation of balloons is done . - The said column (arm) carries multiple protrusions (projections) used to close the openings of balloons during inflation according to the operator’s choice. [Claim 2] The catheter of claim 1, wherein each small said balloon is formed of a single, continuous tube of polymer material. -The said balloon could accept the mounting of stent over it. -The said small balloons have inflation cavities which are independent of each other to enable the balloons to be inflated selectively and inde pendently of each other. Therefore the inflation could be done with different strategies e.g.: -Inflation of 1st balloon only. -Inflation of 1st & 2nd balloons only. -Inflation of 1st & 3rd balloons only. -Inflation of 2nd & 3rd balloons only. -Inflation of the three balloons together. -Inflation of any of them with different pressures and to different diameters. [Claim 3] The existence of separate slots (openings) facing the said balloons to inflate each balloon separately. These said slots (openings) are present at the end of the catheter shaft and are adjacent, at regular intervals and each of which connects to the balloon facing it. (refer to claiml). [Claim 4] The existence of a sliding wire/ arm/axis (column) to control the inflation openings (refer to n°l). [Claim 5] The existence of different projections(protrusions) in the said column “arm” (refer to claim 4) to close the openings of the balloons (refer to claim 3) in an optional manner as needed so that you can inflate one, two or the three balloons at a time (refer to claim 2). -These said projections are on interval distance where (middle) protrusion (at a distance X from the first one ) and third (distal) protrusion ( at a distance from the middle projection equal to 1/2 X). If more than 3 adjacent balloons, the projections should be at regular interval distance except for the last one which is on double the interval distance. [Claim 6] The existence of a connection at the end of the sliding column (refer to claim 4) connected to one inflation device (endflator) used for all the balloons, which reduces the cost and space used during the operation. [Claim 7] The existence of labels (marks) on the inflation part of the catheter shaft (refer to claim 1) with marks guiding the movement of the sliding column (refer to calim 4) to the distance required for inflation of different balloons according to the needed strategy of inflation (refer to claim 2). These motions are controlled by locks to lock the movement of the sliding column when the desired distance is reached and the target strategy is achieved. [Claim 8] A method for performing the dilatation of a vessel (lesion) with different diameters or different calcifications along its length (as defined in claim 1, 2): -Placing the balloon inside the target vessel opposite the target lesion. -Controlling the sliding column according to the desired strategy. 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. 2. The inflating pressure of each balloon is controlled by the endflator, but each small balloon is inflated according to different needs and pressure. 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. 4. Reinflation of any part (point of a vessel) could be done after de livering of the stent if there is tight lesion or much calcification at such point by inflation the corresponding small balloon to more desirable pressure and /or diameter. |
The invention is in the field of medical engineering. It is concerned with medical equipment used in cardiovascular catheterization. Background Art:
Narrow and stenosed arteries are dilated by the interventional catheterization techniques and under the catheter device (cath lab). This is done by using balloons or by stenting the artery using metallic stents to keep the artery open. The doctor inserts a catheter that carries a small balloon into the artery through the arteries of the thigh or arm and directs it to the place of constriction in the coronary artery, for example. The stents also are installed (mounted) on balloons. The diameter of the stent increases gradually with increased the pressure of its balloon inflation up to a certain extent ( the maximum burst pressure) after which the balloon bursts.
The balloon is made of special material that is resistant to pressure, cracking or explosion and sometimes withstands 20 times the value of atmospheric pressure. These materials are all compatible with the body such as polyethylene or nylon.
The balloons used in the treatment and expansion of narrow blood vessels could be balloons with low pressure, medium or high pressure. That refers to the amount of pressure needed to inflate such balloon before it bursts. Stents used in the treatment of these lesions (narrowing) are also installed on balloons with different pressures.
The empty balloon catheter is placed, then inflated to perform the necessary procedure, and deflated again before removal. When the balloon is inflated it expands the stents. When the balloon is emptied later, the stent remains against the arterial wall and the balloon catheter could be then removed. This depends on the pressure needed to inflate the balloon. Each of these balloons is used according to the narrowness and calcification of the site of injury in the artery with the necessary pressure increases the greater the narrowing or calcification on the affected part of the artery.
Each balloon has a minimum pressure that allows it to be extended to the radius assigned to it and has a maximum pressure that will explode if exceeded.
The balloons could be compliant (its diameter increases continuously with increased pressure of inflation but with maintaining low internal pressure) and non compliant (ie, increasing the internal pressure of the balloon with increased inflation pressure but without considerable increase in diameter, allowing the dilatation of tightly stenosed or heavily calcified areas of the arteries).
The problem or shortcomings in the previous art:
In many cases, the diameter of the artery differs in the upper part of the artery from the lower part. In other cases, the diseased segment of the artery has different severity and calcification along its whole length. Therefore, the choice of the diameter of the needed balloon and the amount of pressure that the balloon inflates is confusing and problematic.
If the balloon is inflated with low pressure suitable for the small part of the artery, the widely large segment of the artery will not benefit from balloon inflation. If the balloon is inflated at high pressure, the diameter of the balloon and stent will increase more than the diameter of the small part of the artery, which may cause rupture of the artery. Therefore, doctors use a balloon (or a balloon-mounted stent) with low pressure that partially opens the narrowness first to widen the narrow part of the artery and then another higher pressure balloon is used to expand the part of the artery with the wider diameter.
The type of balloon in this case is called (non-compliant) which has a length similar to the remaining narrowing length to complete the expansion of the artery and confirm the positioning of the stent completely against the arterial wall.
More than one balloon may be used with different pressures to expand the different parts of the artery with different diameters and different calcification ratio. This increases the cost and carries a risk each time to rupture the artery.
In some cases, an internal fracture of the implanted stent may occur depending on the quality of the stent and the anatomical area in which this stent is located example, in the“below knee” region which moves periodically and in different directions. Disclosure Of Invention
This invention (the variable pressure arterial balloon) is a balloon made up of many small balloons that merge with each other along the balloon column. The column contains multiple slots (ports) that can be detected separately during blowing so that the blowing pressure is directed to only one slot at a time.
Each part has different pressure properties so that different tolerable pressures are likely.
Each section has a separate outlet that is used to inflate it with the desired pressure according to the narrowing and calcification of the corresponding arterial wall.
We can inflate each part individually with different pressures according to need and calcification ratio and confirm the placement of the local stent against the wall of the artery and adjacent to it completely without the need for other balloons that are non-compliant with many complications and add additional cost.
Detailed Description:
The balloon usually consists of a column with a cavity that allows for a very thin guide wire (0.014 inches).
In the arm there is another cavity used to inflate the balloon, which is usually used with saline solution (not air).
At the end of the balloon arm, there is an inflator. 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- 4mm)
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).
The arm at the end of the balloon has several adjacent openings at regular intervals, each of which corresponds to the balloon facing it. 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.
How to operate:
1 - When inflating the balloon, 2 protrusions will be closing the opposite ballons 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.
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.
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. Method of exploitation:
1- Experiments and follow the required rules according to the Egyptian Ministry of Health
2 - fulfilling the requirements of the Food and Drug Organization to obtain the necessary license for use in the United States and then in the rest of the world
3 - Used in the management of coronary arteries and peripheral lesions, especially with inhomogeneous narrowing and calcification
4 - Stents could be mounted on the balloon to be implanted in the coronary or peripheral arteries.
4-Brief description of the drawing
1- The first balloon
2. Second balloon
3. The third balloon
4 - The sliding column (arm) of inflation which is connected to the endflator
5. First (distal) protrusion.
6. Second (middle) protrusion (at a distance X from the first one (n°
5))·
7. Third (distal) protrusion ( at a distance from the middle projection (n° 6) equal to 1/2 X).
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