Device for transfer of medications onto blood vessel wall

FIELD: medicine.

SUBSTANCE: invention relates to the field of medicine, in particular to vascular surgery, and is intended for transfer of medications onto an internal surface of a vessel wall. A device for transfer of medications onto the internal surface of the vessel wall contains a matrix, made in the form of a polymer film, covered with medication and placed on a flexible framework. The matrix and the framework have specified standard sizes. They are made with a possibility of placement in them of a cellular knitted metal temporary stent and with a possibility to be inside the temporary stent of an inflatable balloon with a fixed diameter and length and a cylindrical or conic shape when blowing under high pressure or a latex balloon with a possibility of filling the entire internal space of the temporary stent when blowing under low pressure.

EFFECT: invention makes it possible to simultaneously perform long-term efficient transfer of medication into the vessel wall with preservation of blood flow and efficient diameter of the affected vessel.

4 cl, 1 dwg

 

The invention relates to medicine, in particular to vascular surgery.

Known temporary wire mesh stent is used for maintaining effective lumen of a blood vessel or certain required amount of time. A temporary stent is not covered by the drug. Therefore, it is the transfer of drugs to the inner surface of the vascular wall to heal her injuries after intravascular intervention is not possible (Patent No. 2186547, EN).

For transfer of drugs to the inner surface of the vascular wall to heal her injuries after intravascular interventions use a known balloon catheters coated on their surface medicinal substances (Patent WO No. 2010/079218). However, this technical solution has the following disadvantages:

1. Time inflating the balloon, i.e., the direct contact of the outer surface of the cylinder covered with medicine, with the inner surface of the vascular wall, is limited to a maximum of 10 minutes

2. Because of the rigidity of the balloon portion of the catheter is formed by inflating high pressure of 5 ATM, and because of the presence of irregularities of the inner surface of the blood vessel is heterogeneous (loose contact with the surface of the container.

3. After deflation of the balloon blood vessel promptly the Xia to the reduction in diameter and makes ineffective the size for the implementation of the flow.

The aim of the invention is the elimination of the above disadvantages by the possibility of increasing drug exposure time (up to hours, days, weeks) by creating a device with a polymeric matrix, providing a snug fit to the damaged walls of the blood vessel, and create the necessary effective blood flow using a temporary stent.

This is achieved in that the device comprises a matrix made in the form of a polymeric film coated with a medicinal substance and placed on a flexible frame, the matrix and the frame have certain sizes and made with the possibility of location inside of them temporary knitted mesh metal stent and being inside the temporary stent of the inflatable balloon with a fixed diameter and length and a cylindrical or conical form when inflating high pressure or latex balloon with an opportunity to fill the entire inner space of the temporary stent during inflation with low pressure. The use of latex balloon prevents sagging of medicine in the cells of the stent and thus achieves a more dense and efficient contact of the film with medication with a rough inner surface of the vascular wall.

In addition, the matrix frame when ODA is defined medical indications can be used without a temporary stent, only located inside the inflatable balloon with a fixed size (diameter and length) and shape (cylindrical or conical) when inflating, including high blood pressure, or latex balloon with an opportunity to fill the entire inner space of the matrix cage when inflating with low pressure.

In addition, the framework and the matrix can be made of absorbable material, thereby reducing the load on the damaged wall of a blood vessel after a certain time required for therapeutic effects of the medicinal substance.

In addition, the frame may be made of a polymeric material or a metal wire, forming the shape of the body of rotation, and having a device for insertion and removal from a blood vessel.

In addition, the matrix can be coated with pharmaceutical substances on both sides. For example, the outer side (the surface in contact with the inner surface of the injured vascular wall) cytostatic agents or immunomodulators, and the inner side (in contact with the bloodstream) - anticoagulants or antiplatelet drugs.

The drawing shows the proposed universal matrix.

The device consists of a matrix 1 in the form of a polymer film with a medicinal substance, placed n the flexible frame 2, which can be made of absorbable material. In addition, the frame 2 may be made of a polymeric material and a metal wire and has a device 3 for insertion and removal from the blood vessel. The matrix can be coated on both sides (outer 4 and inner 5) medicinal substances. Inside the matrix 1 and the frame 2 is placed a temporary wire mesh stent 6. If necessary, the inside of the stent 6 may be placed inflatable cylinders with different characteristics (in the drawing not shown).

Work with the claimed device is as follows. In the narrowed blood vessel impose a standard inflatable balloon without printed on its outer surface medicinal substance (in the drawing not shown). The diameter of the cylinder is chosen closer to the maximum reference size of the vessel to achieve when the extension of the maximum possible (efficient) of the vessel lumen. For expansion of the narrowed segment of the vessel, the balloon inflate and blow it away. Then in the advanced segment of the vessel with the help of the device 3 device for insertion and removal) take the matrix 1 with frame 2 of the appropriate size. Then inside the matrix 1 with frame 2 enter a temporary stent 6 diameter corresponding reference vessel diameters, while pulling from delivering the Catete the RA (in the drawing not shown) takes its true diameter and tightly presses the outer surface 4 of the matrix 1 to the inner surface of the vascular wall, providing a snug fit and the transition of medicine from the surface 4 on the inner surface of the vascular wall within a much larger time (hours, days, weeks)than when inflating balloon catheter (not more than 10 minutes). However, if you are using a balloon catheter for delivery of a drug (less than 10 min) blood flow is completely blocked (not physiological), when using the design matrix 1 with a frame 2 and a temporary stent 6 the flow is fully preserved, and it allows you to carry out this operation - long-term drug effects on the inner surface of the damaged wall of a blood vessel with preserved blood flow (provides temporary stent) within a much larger time (hours, days, weeks) depending on medical indications.

If necessary, inside the temporary stent 6 can be placed:

1. An inflatable bladder (in the drawing not shown) with a fixed size (diameter and length) and shape (cylindrical or conical) for inflating, including high pressure for a more complete temporary straightening metal stent 6 when caliciviruses changes of the vascular wall.

2. Or latex balloon (in the drawing not shown) to fill the entire inner space of the temporary stent during inflation with low giving is the group to prevent sagging of the film with medication in the cells of the stent and, thus, achieving this more dense and effective contact of the film with medication with the inner surface of the vascular wall

In addition, the frame 2 and the matrix 1 can be made of absorbable material, thereby reducing the load on the damaged wall of a blood vessel after a certain time required for therapeutic effects of the medicinal substance.

In addition, the matrix 1, the frame 2 can be covered with pharmaceutical substances (4 outer, inner 5) on both sides.

For example, with 4 outer side (the surface in contact with the inner surface of the injured vascular wall) cytostatic agents or immunomodulators to reduce proliferative inflammatory reaction on the part of the injured inner surface of the vascular wall 5 and the inner side (in contact with the bloodstream) - anticoagulants or antiplatelet drugs for prevention of thrombotic complications during surgery.

In some medical cases, possibly inside the matrix 1 with frame 2 without using a temporary stent 6 location:

1. Inflatable balloon (in the drawing not shown) with a fixed size (diameter and length) and shape (cylindrical or conical) when inflating, including high pressure d is I a snug fit matrix with medication to the inner surface of the injured vascular wall.

2. Or latex balloon (in the drawing not shown) to fill the inflated balloon of the entire internal space of the matrix 1 with frame 2 when inflating with low pressure. Latex balloon completely takes the shape space, where he finds himself. And in the case of its use in the above situations, when there is an uneven inner surface of the vessel wall, allows a tighter fit of the matrix 1 with medication to the uneven inner surface of the vessel wall and more efficient transfer of drugs.

Inflatable balloon high pressure when inflating retains its: diameter, length, and shape (cylindrical or conical), and latex balloon takes the shape of inner space, where it is inflated.

Surgery ends with the destruction of balloon catheters, temporary stent 6, matrix 1 with a frame 2 with the help of the device 3.

Thus, the combination of the described features allows you to simultaneously carry out long-term, effective transfer of the drug into the vessel wall with preserved blood flow and the effective diameter of the affected vessel.

1. Device for transmission of medicinal substances on the inner surface of the wall of the blood vessel, characterized in that it contains a matrix that is made in the form of a polymeric film coated with Carstensen substance and placed on a flexible frame, the matrix and the frame have a certain standard sizes and made with the possibility of location inside of them knitted mesh metal temporary stent and with the possibility of being inside the temporary stent of the inflatable balloon with a fixed diameter and length and a cylindrical or conical form when inflating high pressure or latex balloon with an opportunity to fill the entire inner space of the temporary stent during inflation with low pressure.

2. The device according to claim 1 characterized in that the frame is made from absorbable or polymer material, or a metal wire, forming the shape of the body of rotation, and has a device for insertion and removal from a blood vessel.

3. The device according to any one of claims 1, 2, characterized in that the matrix is made of absorbable material.

4. The device according to any one of claims 1, 2, characterized in that the matrix is covered with a medicinal substance on both sides.



 

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