WO2008072243A2

WO2008072243A2 - Methods and devices to remove blood clot and plaque deposit

Info

Publication number: WO2008072243A2
Application number: PCT/IL2007/001546
Authority: WO
Inventors: Dan Nahoom
Original assignee: Dan Nahoom
Priority date: 2006-12-15
Filing date: 2007-12-13
Publication date: 2008-06-19
Also published as: WO2008072243A3

Abstract

Improved catheters are provided to remove a plaque deposited on a vessel' inner wall. The plaque from the inner wall of the vessel is removed by physical means such as adhering or rinsing. The plaque is then being eliminated from the vessel.

Description

METHODS AND DEVICES TO REMOVE BLOOD CLOT AND

PLAQUE DEPOSIT

FIELD OF THE INVENTION

The present invention relates to release of blood vessel blockage. More particularly, the present invention relates to removal of plaque and blood clot blockage in blood vessel including but not only during balloon angioplasty procedures or restenosis procedure

BACKGROUND FO THE INVENTION

Cardiovascular disease is one of the major causes of death in the modern world. Coronary artery disease (CAD) is a condition in which plaque builds up inside the coronary arteries. Theses arteries supply the heart muscle with oxygen-rich blood. The plaque is made up of fat, cholesterol, calcium and other substances found in the blood that forms a condition of atherosclerosis which means partial or fully blocked arteries. CAD weakens the heart muscle and may lead eventually to heart failure. Blood clots which are a consequence of plaques can also build up in other arteries and blood vessels that form conditions in which the body is susceptible to different diseases. Blockage of neck arteries, for example, leads to risk of stroke. The main procedure to treat blood vessels blockage nowadays is stent insertion while the diagnosis is usually made by angioplasty procedure while a catheter with balloons is inserted to within the vessel. Catheters, in general, are widely used in order to access the vascular system as well as other vessels or cavities in the body. Catheters are mainly used for infusion of therapeutics and for insertion or placement of substances or apparatii for treating the different conditions in the vessels. Since the catheter is already inserted to the vessel as diagnostic procedure or for treatment, it is desirable to use the catheter in a different manner in order to unblock the plaque or clot in the vessel.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improved catheter adapted to physically remove a plaque or clot of a vessel or any other body cavity.

It is yet another object of the present invention to provide an improved catheter for angioplasty capable of removing a plaque of the vessel during angioplasty procedure.

It is another object of the present invention to provide an improved catheter having a treated outer surface capable of adhering plaque material so as to remove it from the vessel.

Yet, it is another object of the present invention to provide a method of cleaning a vessel or another bodily cavity from a plaque using an improved catheter. It is yet another object of the present invention to provide a method of cleaning a vessel from a plaque using an improved catheter during angioplasty procedure.

It is an additional object of the present invention to provide an improved catheter having means to rinse a plaque material so as to remove it. It is therefore provided in accordance with a preferred embodiment of the present invention an improved catheter for removing material attached to an interior wall of a vessel or bodily cavity comprising: catheter having a proximal side and a distal side capable of being inserted into the vessel or cavity; at least one expander provided to said distal side wherein said expander is capable of expanding and contracting; a layer provided on a surface of said at least one expander wherein said layer has adhering characteristics.

Furthermore, in accordance with another preferred embodiment of the present invention, said expander is a balloon capable of being inflated and deflated.

Furthermore, in accordance with another preferred embodiment of the present invention, said layer has adherence forces that are greater than the adherence forces that attached the material to the vessel or bodily cavity.

Furthermore, in accordance with another preferred embodiment of the present invention, said surface is selected from a group of surfaces such as glue, porous, perforated, elastic mesh or a combination therein.

It is therefore provided in accordance with another preferred embodiment of the present invention, an improved catheter for vessel blockage removal comprising: a catheter having a distal side and a proximal side capable of being inserted into the vessel; at least two balloons positioned in said distal side adapted to be inflated in a predetermined distance one from the others; at least one first tubing provided in said catheter wherein said first tubing is provided with at least one opening positioned between the balloons and at least two openings associated with said at least two balloons; at least one second tubing wherein said second tubing is provided with at least one opening positioned between the balloons.

Furthermore, in accordance with another preferred embodiment of the present invention, rinsing material can be pressurized through the first tubing outwardly through the distal side and sucked from said distal side outwardly to said proximal side. Furthermore, in accordance with another preferred embodiment of the present invention, said first tubing transfers rising fluid to said at least two balloons so as to inflate the balloons. It is therefore also provided in accordance with an additional preferred embodiment of the present invention, a method of removing a plaque deposited on a vessel's inner wall comprising: providing an improved catheter having a distal side and a proximal side capable of being inserted to within the vessel; providing active surface to said distal side; inserting said improved catheter into the vessel; physically removing the plaque; withdrawing said improved catheter. Furthermore, in accordance with another preferred embodiment of the present invention, said active surface is a layer of adhesive material. said improved catheter is provided with at least one balloon in said distal side and said active surface is provided on the balloon.

Furthermore, in accordance with another preferred embodiment of the present invention, said active surface is a layer selected from a group of materials such as porous material, perforated material or meshed material.

Furthermore, in accordance with another preferred embodiment of the present invention, said improved catheter is provided with at least one balloon and said porous or elastic mesh material is provided on said balloon. Furthermore, in accordance with another preferred embodiment of the present invention, said active surface comprises a combination of layers having different characteristics.

It is further provided in accordance with another preferred embodiment of the present invention, a method of removing a plaque deposited on a vessel's inner wall comprising: providing an improved catheter comprising: a catheter having a distal side and a proximal side capable of being inserted into the vessel; at least two balloons positioned in said distal side capable of being inflated in a predetermined distance one from the others; at least one first tubing extending from said distal side to said proximal side wherein said first tubing is provided with at least one opening positioned between the balloons for rinsing and openings associated with the balloons for inflating; at least one second tubing extending from said proximal side to said distal side wherein said second tubing is provided with at least one opening positioned between the balloons; inserting said improved catheter to within the vessel; inflating the balloons so as to confine the plaque between the balloons; pressurizing rinsing material through said first tubing to within and between the balloons; sucking and discharging the rinsing material through said second tubing from between the balloons; withdrawing said improved catheter from the vessel.

Furthermore, in accordance with another preferred embodiment of the present invention, said rinsing material can be selected from a variety of materials having chemical, mechanical or therapeutically characteristics.

Additionally and in accordance with another preferred embodiment of the present invention, said pressurizing rinsing material can be performed in various sequences, temperatures, frequencies, and pulses.

BRIEF DESCRIPTION OF THE FIGURES

In order to better understand the present invention and appreciate its practical applications, the following figures are attached and referenced herein. Similar components are denoted by similar reference number. Please Note the figures are given as an example and a preferred configuration only, and do not limit the scope of the present invention in any way, as defined in the appending Description and Claims.

Figures 1a, b illustrate two views of an improved catheter for vessel blockage removal in accordance with a preferred embodiment of the present invention.

Figure 2 illustrates a cross sectional view of a blocked blood vessel with an improved catheter within the vessel in accordance with a preferred embodiment of the present invention. f

Figures 3a, b illustrate an improved catheter for blood vessel blockage removal in accordance with another preferred embodiment of the present invention, in two states.

DETAILED DESCRIPTION OF THE INVENTION AND FIGURES

The present invention provides novel and unique catheters adapted to be inserted to within bodily cavities such as vessels and remove a plaque or blockage that is attached to the walls of the cavity or vessel.

According to one aspect of the present invention, the improved catheter is used for blood vessels; therefore the catheter is designed to be inserted to within blood vessels such as an artery. The design of the catheter is based on dimensions that are known to people skilled in the art. However, the improved catheter is used to remove the material adhered on the internal walls of the vessel to outside the body.

According to one aspect of the present invention, a catheter is provided with an active surface such as a surface having adherence properties capable of adhering the deposited material from the walls of the vessel. The use of the words "plaque", "deposit" and "clot" are exchangeably used in order to describe the blocking material that is adhered in the vessel's inner walls.

Reference is now made to Figure 1 illustrating two views of an improved catheter for vessel blockage removal in accordance with a preferred embodiment of the present invention. The vessel can be a natural or artificial vessel. Blood vessel blockage removal apparatus comprises a tube or a catheter 2 capable of being inserted through a blood vessel, as an example. A guide wire 1 passes through tube 2 wherein the guide wire is used in a conventional manner. A balloon 3 is provided substantially at the end of tube 2. Balloon 3 is adapted to be inflated when the tube is within the blood vessel. Balloon 3 is inflated through dedicated tubing that is usually inserted to within the wall of the catheter having an opening in the proximal portion of the catheter, in a way known in the art. It should be noted that the catheter can be design in any other arrangement having more than one balloon, or inserted without a guide wire, and still be improved to be the improved catheter of the present invention without limiting the scope of the present invention.

A portion of the balloon or the whole. surface of the balloon is provided with an abrasive layer or adhesive material 4. If an adhering material is to be used on the exterior surface of the balloon, when the balloon is inflated within the blocked vessel, the adhering material on the face of the balloon is being adhered to the blocking material that covers the vessel wall. By using an adhering material that has adherence forces greater than the adherence forces of the blockage material that is deposited on the interior wall of the vessel or to itself, the blocking material will stick to the balloon's surface when the balloon is being deflated and removed from the place of blockage.

The adhering material can be any glue having adhering characteristics as an example, a glue that is activated under pressure. It should be noted that the surface of the balloon can be provided with different types of adhering materials and the material can be changed according to the character of the blockage, and vessel, etc. It should be noted that the balloon type catheter is given herein as a preferable embodiment; however, any other device or mechanism that is capable of expending the boundaries of the catheter so as to reach the diameter of the vessel can be used in order to adhere the blocking material to the catheter. Any other types that can be designs are limited to the scope of the present invention and by no means limit the scope of the present invention.

The same manner applies when a porous, perforated or an elastic mesh outer layer is used on the surface of the balloon. When the balloon is inserted and inflated to within the area that is blocked by a plaque, as an example, the adhered material of the blockage is removed from the vessel's wall in a manner that is used using a tissue or a sponge so that the adhered blocking material is attached to the outer layer of the balloon.

It should be noted that a combination of surfaces can be used also so as to make the blockage removal more efficient. As an example, a portion of the layer on the balloon surface of made of an porous material and another portion is made of a adhering material.

It should be noted also that the material from which the outer layer of the balloon is made of can be any type of material that is capable of binding to the blockage material on the walls of the vessels without damaging the vessels themselves. Any type of porous, perforated, or an elastic mesh material can be used to design the improved catheter of the present invention without limiting the scope of the invention coverage.

Reference is now made to Figure 2 illustrating a cross sectional schematic view of a blocked blood vessel with an improved catheter within the vessel in accordance with a preferred embodiment of the present invention. Blood vessel 10 is blocked with a plaque 12. A catheter 14 having a balloon 16 at its end is being inserted to within blood vessel 10. When the balloon is in the blockage area, it is inflated. The adhering material that is provided on the surface of balloon 16 sticks to plaque 12 and the plaque material is physically removed of the surface of the blood vessel and outwardly with the un-inflated balloon when the catheter is being removed. Optionally, the improved catheter of the present invention is inserted to the proper location in the vessel or bodily cavity or removed from it while having a protective device onto the surface so as to protect the surface when the catheter is inserted or removed. Such a protector can be a sheath that allows the balloon with the operating surface be exposed only when the catheter is in the blockage area where the surface is to be operable.

In another aspect of the present invention, the blocking material that is adhered to the walls of the vessel is being rinsed using a stream of fluid.

Reference is now made to Figures 3 a and b illustrating an improved catheter for vessel blockage removal in accordance with another preferred embodiment of the present invention, in two states. According to this aspect of the present invention, the plaque within the blood vessel is rinsed or emulsified using a jet of rinsing material. The rinsing material passes through an improved catheter that is inserted into the blood vessel. The rinsing or the emulsifying action can be performed mechanically, chemically, by temperature change, or any combination of the above without limiting the scope of the present invention.

Optionally, the rinsing material can be changed during the procedure in order to achieve higher result or healing process according to the nature of the process blockage.

Figure 3a depicts the structure of improved catheter 100 that is provided with two balloons - a first balloon 102 that is positioned at the end of catheter

100 and a second balloon 104 positioned at a predetermined distance from first balloon 102. When the balloons are inflated within a blood vessel 106 and are pressed to the vessel, there is a vacancy 108 confined between the balloons, the catheter, and the vessel. Vacancy 108 is the segment to be rinsed. Any plaque or clot material that is adhered to the vessel in this area is rinsed. It is important to notice that the rinsing material can pass through passages in the catheter and cannot pass to other portions of the blood vessel. Catheter 100 is provided with a guiding wire 120.

In order to better understand the passageways in catheter 100 and the rinsing procedure, reference is made to Figure 3b. Rinsing material is pumped to within catheter 100 through an inlet tube 110. First, at a low pressure, the balloons are inflated through ports 118 and then, while the pressure rises to a higher value, the rinsing material is being discharged from the tube through ports 112 to vacancy 108 where the plaque is present and is being loosen and sucked outwardly through outlet openings 114. The rinsing material and the particles that are being rinsed are discharged from catheter 100 through suction tube 116.

As mentioned herein before, the rinsing material can be any type of liquid which can be also an active liquid that will chemically or mechanically interact with the plaque so as to establish substantially and totally removal of the plaque. The liquid can be heated to different temperatures or can be pressurized in sequences with different frequencies. Different rinsing materials can be provided in the different sequences or pulses.

Moreover, the rinsing material can be provided with materials that will have a therapeutic effect on the treated area.

It should be emphasized that a pressure supporting system is provided to the catheter in order to deliver the rinsing material to within the catheter and from it during the operation of the device. As customary in this industry, filters, pumps and additional accessories are provided. It should be noted that the passages of the tubing through the walls of the catheter is made as customary in the industry as well as the openings of the tubing that allows inflating and deflating the balloons as well as pushing the rinsing material through the blockage.

It should be clear that the description of the embodiments and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope as covered by the following Claims.

It should also be clear that a person skilled in the art, after reading the present specification can make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the following Claims.

Claims

C L A I M S

1. An improved catheter for removing material attached to an interior wall of a vessel or bodily cavity comprising: catheter having a proximal side and a distal side capable of being inserted into the vessel or cavity; at least one expander provided to said distal side wherein said expander is capable of expanding and contracting; a layer provided on a surface of said at least one expander wherein said layer has adhering characteristics.

2. The improved catheter as claimed in Claim 1 , wherein said expander is a balloon capable of being inflated and deflated.

3. The improved catheter as claimed in Claim 1 , wherein said layer has adherence forces that are greater than the adherence forces that attached the material to the vessel or bodily cavity.

4. The improved catheter as claimed in Claim 1 , wherein said surface is selected from a group of surfaces such as glue, porous, perforated, elastic mesh or a combination therein.

5. An improved catheter for vessel blockage removal comprising: a catheter having a distal side and a proximal side capable of being inserted into the vessel; at least two balloons positioned in said distal side adapted to be inflated in a predetermined distance one from the others; at least one first tubing provided in said catheter wherein said first tubing is provided with at least one opening positioned between the balloons and at least two openings associated with said at least two balloons; at least one second tubing wherein said second tubing is provided with at least one opening positioned between the balloons.

6. The improved catheter as claimed in Claim 5, wherein rinsing material can be pressurized through the first tubing outwardly through the distal side and sucked from said distal side outwardly to said proximal side.

7. The improved catheter as claimed in Claim 5, wherein said first tubing transfers rising fluid to said at least two balloons so as to inflate the balloons.

8. A method of removing a plaque deposited on a vessel's inner wall comprising: providing an improved catheter having a distal side and a proximal side capable of being inserted to within the vessel; providing active surface to said distal side; inserting said improved catheter into the vessel; physically removing the plaque; withdrawing said improved catheter.

9. The method as claimed in Claim 8, wherein said active surface is a layer of adhesive material.

10. The method as claimed in Claim 9, wherein said improved catheter is provided with at least one balloon in said distal side and said active surface is provided on the balloon.

11. The method as claimed in Claim 8, wherein said active surface is a layer selected from a group of materials such as porous material, perforated material or meshed material. .

12. The method as claimed in Claim 11 , wherein said improved catheter is provided with at least one balloon and said porous or elastic mesh material is provided on said balloon.

13. The method as claimed in Claim 8, wherein said active surface comprises a combination of layers having different characteristics.

14. A method of removing a plaque deposited on a vessel's inner wall comprising: providing an improved catheter comprising: a catheter having a distal side and a proximal side capable of being inserted into the vessel; at least two balloons positioned in said distal side capable of being inflated in a predetermined distance one from the others; at least one first tubing extending from said distal side to said proximal side wherein said first tubing is provided with at least one opening positioned between the balloons for rinsing and openings associated with the balloons for inflating; at least one second tubing extending from said proximal side to said distal side wherein said second tubing is provided with at least one opening positioned between the balloons; inserting said improved catheter to within the vessel; inflating the balloons so as to confine the plaque between the balloons; pressurizing rinsing material through said first tubing to within and between the balloons; sucking and discharging the rinsing material through said second tubing from between the balloons; withdrawing said improved catheter from the vessel.

15. The method as claimed in Claim 14 wherein said rinsing material can be selected from a variety of materials having chemical, mechanical or therapeutically characteristics.

16. The method as claimed in Claim 14, wherein said pressurizing rinsing material can be performed in various sequences, temperatures, frequencies, and pulses.