RU2766737C2 - Catheter with positioning markers - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to medical equipment, namely to invasive medical procedures, such as angioplasty, and, more specifically, to a catheter with markers for correct positioning in the treated area. A set for influencing the treated area in the vascular bed contains the first pre-dilation catheter and the second dilation catheter. The first pre-dilation catheter has the first shaft containing the first distal part, made with the possibility of positioning in the treated area, and the first proximal part containing the first marker in the first place. The second dilation catheter has the second shaft containing the second distal part, made with the possibility of positioning in the treated area, and the second proximal part containing the second marker in the second place, essentially coinciding with the first place of the first marker. The first and the second markers contain dotted lines forming a ruler graded with numbers. The first and the second markers are radiopaque. A device for influencing the treated area inside vessels of the body contains a catheter containing a shaft having a distal part including a cylinder carrying a drug, and a proximal part including at least one radiopaque marker made with the possibility of observing it at a reference point in the body in order to determine the location of the treated area relatively to the reference point. The marker contains dotted lines forming a ruler graded with numbers. A method for influencing the treated area in the body includes the administration of the distal part of the first catheter into the treated area; determination of the location of the first radiopaque marker on the proximal part of the first catheter relatively to the reference point, and the administration of the second catheter until the second radiopaque marker on the second catheter corresponds to the reference point, wherein the first and the second markers contain dotted lines forming a ruler graded with numbers. The method for influencing the treated area in the vascular bed includes providing the first catheter having the first shaft containing the first distal part, made with the possibility of positioning in the treated area, and the first proximal part containing the first radiopaque marker in the first place; and providing the second catheter having the second shaft containing the second distal part, made with the possibility of positioning in the specified first place, and the second proximal part containing the second radiopaque marker in the second place, essentially coinciding with the first place of the first radiopaque marker, where the first and the second markers contain dotted lines forming a ruler graded with numbers.

EFFECT: use of inventions provides for the creation of the first catheter with a marker along the proximal part for use in order to determine the location relatively to the treated area in a place located outside the body, as well as provides for the second catheter with a corresponding marker for subsequent treatment in the same treated area.

13 cl, 8 dwg

Description

This patent application claims priority under US Provisional Application No. 61/747,416, the contents of which are hereby incorporated by reference.

Technical field

The present invention relates generally to invasive medical procedures such as angioplasty and more particularly to a catheter with markers for correct positioning in the treated area.

Background of the Invention

Balloon catheters are commonly used to solve problems associated with restriction or even complete blockage of the flow of fluids in tubular body structures such as arteries or veins. In many clinical situations, these restrictions are caused by the presence of particulate matter, such as calcified plaques, and the nature of these restrictions can sometimes result in the obstruction being subjected to high pressure to compress such particles. Commercially available cylinders are manufactured using sophisticated technology to meet high pressure requirements without compromising the geometry of the cylinder profile. In addition to the need to meet high pressure requirements, balloons must be puncture resistant, easy to pass through tortuous canals and push through tight canals, and low profile, especially when used in angioplasty.

The physician performing the angioplasty procedure needs to be able to pinpoint the exact location of the deflated balloon in order to properly position it when inflated. This is usually done by attaching marker strips to the catheter shaft at locations corresponding to the ends of the balloon working surface. This "working surface" is the surface along the part of the balloon used to achieve the desired therapeutic effect, that is, in contact with the calcified plaque (this surface, in relation to the balloon, having conical or tapering parts at the proximal and distal ends, corresponds mainly to the cylindrical part balloon).

However, incorrect positioning of the marker strips when applied along the catheter shaft sometimes leads to their inaccurate correspondence to the location of the working surface. Due to this incorrect positioning, the doctor may not accurately determine the location of the working surface of the balloon during catheterization. In addition, during intravascular intervention, for example in the process of predilatation with the first catheter followed by dilation with the second catheter, the doctor will not be able to accurately determine the actual location of the predilatation. In any case, this uncertainty can lead to incorrect positioning, or "missing", of the required contact between the treated area and the working surface of the balloon. It is particularly desirable to avoid this outcome when the balloon is intended to deliver a payload (such as a therapeutic agent (eg, a drug such as paclitaxel, rapamycin, heparin, etc.), a stent, stent graft, or a combination thereof) or a working an element (such as a cutting instrument, a directional guidewire, etc.) to a specific location in the vasculature, since a miss may at least lengthen the procedure itself (for example, due to the need to reposition the balloon or use a different balloon catheter, as in the case of a drug-eluting balloon) and the beneficial effect will be reduced if the affected area is not properly treated due to incorrect positioning.

Thus, the actual task is to create a method for more accurate positioning of the balloon catheter in the vascular bed in the treated area, additionally characterized by a high degree of reproducibility.

Brief summary of the present invention

The purpose of the present invention is to provide a first catheter with a marker along the proximal portion (eg, proximal to the distal portion, including any balloon) for use in determining position relative to the treated area at a location outside the body. A second catheter with an appropriate marker may also be provided for subsequent treatment in the same treatment area.

In accordance with one aspect of the present invention, there is provided a set for influencing a treatment area in the vascular bed, comprising a first pre-dilatation catheter having a first shaft containing a first distal part intended for positioning in the treatment area, and a first proximal part containing a first marker in the first place ; and a second dilatation catheter having a second shaft containing a second distal portion intended for positioning in the treated area and a second proximal portion containing a second marker at a second location substantially coinciding with the first location of the first marker.

The first and second markers may contain marks spaced at the same distance from each other, or marks spaced apart from each other at different distances. The first and second markers may be located near the connector of the first and second catheters. The markers may be chemiluminescent or photoluminescent.

At least one of the first and second markers may contain at least one color label. At least one of the first and second markers contains at least two marks of different shades.

Each of the first and second catheters may contain a balloon. The first distal portion may contain one or more radiopaque markers. The second catheter may contain a treatment agent selected from the group consisting of a drug, a stent, a stent graft, a cutting instrument, a directional guidewire, or any combination thereof. One or more markers may be radiopaque. One or more markers may contain a dimple, tubercle, scar, dimple, or any combination thereof.

In accordance with another aspect of the present invention, a device is provided for influencing a treated area within the vessels of the body. The device contains a catheter having a shaft having a distal part, including a balloon carrying a drug, and a proximal part, including at least one marker, designed to observe it at a reference point outside the body in order to determine the location of the treated area relative to the specified reference point.

The balloon may further comprise a treatment agent selected from the group consisting of a stent, a graft, a cutting instrument, a directional guidewire, or any combination thereof. The first and second markers may comprise equidistant bands and may extend from a first location adjacent to the catheter connector to a second location closer to the balloon. The markers may be chemiluminescent or photoluminescent and may contain at least one color mark. The marker may contain at least two marks of different shades and may additionally contain a radiopaque marker. One or more markers may contain a dimple, tubercle, scar, depression, or any combination thereof.

In accordance with yet another aspect of the present invention, a method of influencing a treated area in the body is provided. The method involves inserting the distal part of the first catheter into the treated area, determining the position of the first marker on the proximal part of the first catheter relative to the reference point, and inserting the second catheter until the second marker on the second catheter corresponds to the reference point. The method may further comprise the step of applying the treatment agent to the area to be treated via the second catheter and may further comprise providing the first and second markers of the same color. The position determination step may involve observing the first marker at a location outside the body.

In accordance with another aspect of the present invention, a method of influencing a treated area in the vascular bed is provided. The method involves providing a first catheter having a first shaft containing a first distal part intended for positioning in the treated area, and a first proximal part containing a first marker in the first place; and providing a second catheter having a second shaft containing a second distal portion designed to be positioned at said first location and a second proximal portion containing a second marker at a second location substantially coinciding with the first location of the first marker.

Brief description of the figures

Figures 1-4 show a catheter according to an embodiment of the present invention.

Figures 5 and 6 show elements of a catheter according to an embodiment of the present invention.

Figures 7A, 7B and 8 illustrate the method of using a catheter in accordance with an embodiment of the present invention.

Embodiments of the present invention

The following description, given with reference to these figures, applies to all embodiments of the present invention, unless otherwise indicated, and the elements common to those or other embodiments of the invention have a similar appearance and similar reference designations.

Proposed is a catheter 10 having a distal portion 11 with a balloon 12 mounted on the tube 14 of the catheter. As shown in FIG. 1, 2 and 3, the balloon 12 has an intermediate part 16 or "cylinder" having a working surface W, and end parts 18, 20. In accordance with one embodiment of the invention, the end parts 18, 20 are characterized by a decreasing diameter at the junction of the intermediate part 16 with the catheter tube 14 (and thus the parts 18, 20 are called cones or conical parts). The extremities (proximal end 15a and distal end 15b) of the end portions 18, 20 of the balloon 12 are hermetically connected to the catheter tube 14 to enable the balloon 12 to be inflated through one or more inflation lumen 17 extending inside the catheter tube 14 and communicating with the interior of the balloon 12 .

The catheter tube 14 also includes an elongated tubular shaft 24 defining a guidewire lumen 23 through which the guidewire 26 can be moved through the catheter 10. As shown in FIG. 3, a conductor 26 may be inserted into the first channel 25 of a connector, such as connector 27, to be routed into lumen 23 in an OTW (over the wire) configuration, however, a "quick change" configuration may also be used. English rapid exchange), in which the conductor 26 can be inserted into the lumen through the side hole 14a, located closer to the distal end (see Fig. 4). A second conduit 29 may also be connected to catheter 10, eg via connector 27, to introduce fluid (eg, saline, contrast, or both) into balloon 12 through inflation lumen 17.

The balloon 12 may include a single-layer or multi-layer wall 28. The balloon 12 may be rigid, with its wall 28 retaining its size and shape when the balloon is inflated in one or more directions. In such a case, balloon 12 also has a given surface area that remains constant during and after inflation, as well as a given length in the longitudinal direction and a given circumference, one or both of which remain constant during and after inflation. Otherwise, however, depending on the particular use, balloon 12 may be semi-compliant or compliant.

To improve the control of the location of the catheter elements during catheterization, a marker 30 can be applied to the outside of the main part of the catheter 10 during this procedure, for example, along the tube 14. As shown in FIG. 5, the marker 30 may comprise a plurality of spaced apart marks 32, such as stripes. These marks 32 may extend from a location adjacent to the connector 27 to the proximal end 15a of the balloon or any portion thereof (which is referred to as the "proximal portion" of the catheter 10 as opposed to the distal portion including the balloon 12). The marks 32 may be spaced equally or at different distances from one another (for example, the distances between the marks may gradually decrease over the length of shaft 24). The marks 32 may be of the same color, such as black, as shown in FIG. 5, but may be of different shades or colors, as shown in FIG. 6. Labels 32 may also include dotted lines forming a ruler graduated with numbers, letters or symbols. The marker 30 may also contain a biocompatible chemiluminescent or photoluminescent material that is easily visible in low light conditions, which is often the case with fluoroscopy procedures. Alternatively, or additionally, the marker 30 may be configured to provide tactile feedback, i.e. may contain, for example, depressions, tubercles, scars, depressions and similar elements that can be counted even by touch.

In practice, as shown in FIG. 7A and 7B, a catheter 100 containing a marker 30 may be inserted into the vessel V at a specific treatment area A, which is shown to contain the lesion L, but only to analyze its location by predilatation. The catheter 100 may have a radiopacity property (for example, may include one or more bands 102 located under the balloon 112 and defining the ends of the cylindrical portion 116, or located on the surface of the balloon), which can be used in fluoroscopy to determine the location of the treatment area A. Those skilled in the art in the field of technology it will be clear from figa and 7B that the position of the bands 102 or, the same, any radiopaque marker corresponds to the location of the treatment area A. At this stage, the doctor can see the marker 30 and understand how accurately the catheter 100 is inserted into the treatment area A. This may be accompanied by counting the marks 32 outside the introducer I (see the embodiment of the invention illustrated in Fig. 5) or by observing a certain color or shade of a particular mark 32' (see the embodiment of the invention illustrated in Fig. 6) regarding anchor point R, such as the proximal edge th introductor I, which expresses a specific distance (indicated by the letter X in the figure illustrating the corresponding embodiment of the invention, while X denotes the distance from the connector 27 to the reference point R).

Next, a second catheter or a treatment delivery catheter 200 containing a similar marker 30 is inserted into treatment area A to deliver a treatment agent T (such as drug, stent, stent graft, balloon 212, or combinations). This catheter 200 can be inserted through introducer I until the corresponding mark 32' is aligned with the previously defined reference point R, which can also correspond to the distance X if the catheters 100, 200 are of the same length. It will be apparent to those skilled in the art from this description that with this method of positioning, the working surface of the balloon and the treatment area A are substantially aligned. The above allows the clinician to ensure that the treatment agent is delivered to the treatment area A in the prescribed manner, and also avoids the problem of geometric mispositioning. Further treatment may be provided, for example by inflating the balloon 212 of the second catheter 200 to seal the lesion L and/or to place a stent or stent graft. Radiopaque markers such as bands 202 may optionally be provided to help confirm the location of the balloon 212 of the second catheter 200.

Those skilled in the art will appreciate from the above paragraph and FIG. 7A and 7B that, with respect to these two catheters, and in fact with respect to the treatment kit in the patient's vasculature, the locations of the two markers "combine". Those skilled in the art will appreciate that the same or corresponding marker on both catheters corresponds to the same length measured from the distal tip of the respective catheter. In other words, the same or corresponding marker on both catheters corresponds to at least approximately the same length that the catheter is inserted into the patient's vasculature.

Alternatively, instead of markers 30, or in addition to markers 30, catheter shafts 100, 200 may be marked with one or more radiopaque markers 40 separated by marks 42. As shown in FIG. 8, a similar counting operation can be performed under fluoroscopy during sequential procedures (e.g. interventions), for example, using a different reference point R in the V vessel (including possibly a part of the introductor I, such as the exit or distal end, which can also be made radiopaque).

To illustrate the ideas of the invention, the present document describes specific embodiments of the invention, however, the described embodiments of the invention may be subject to numerous modifications, variations and changes, without contradicting the spirit and scope of the present invention, defined in the attached claims. For example, any ranges and numbers given in relation to various embodiments of the invention may vary due to tolerances, due to changes in environmental factors and material quality, and due to modifications to the structure and shape of the cylinder, and, therefore, can be considered approximate, and the term " approximately" means that the corresponding value may, at a minimum, vary due to such factors. In addition, the figures illustrating the teachings of the invention are not drawn to scale and should not be construed as limiting in any particular size or dimension. Thus, the present invention is not intended to be limited to the described embodiments, but to be limited to the full extent defined by the presentation of the relevant claims and their equivalents.

Claims (27)

1. A kit for influencing the treated area in the vascular bed, containing: the first predilatation catheter having the first shaft containing the first a distal part configured to be positioned in the treatment area, and the first proximal part containing the first marker in the first place; And a second dilatation catheter having a second shaft containing a second distal part configured to be positioned in the treated area and a second proximal part containing a second marker at a second location substantially coinciding with the first location of the first marker, where the first and second markers contain dotted lines forming a ruler graduated with numbers; And wherein the first and second markers are radiopaque. 2. The set of claim. 1, in which the first marker determines the distance to the treated area relative to the reference point in the vascular bed. 3. A set according to any one of the preceding claims, wherein each of the first and second catheters contains a balloon. 4. A device for influencing the treated area inside the vessels of the body, containing: a catheter containing a shaft having a distal part, including a balloon carrying the drug, and a proximal part, including at least one radiopaque marker, made with the possibility of observing it at a reference point in the body in order to determine the location of the treated area relative to the specified reference point, and the marker contains dotted lines forming a ruler graduated with numbers. 5. The device of claim 4, wherein the balloon further comprises a treatment agent selected from the group consisting of a stent, a graft, a cutting instrument, a directional guidewire, or any combination thereof. 6. The device according to claim 4 or 5, wherein the first and second markers comprise equidistant stripes. 7. The method of influencing the treated area in the body, including: introducing the distal portion of the first catheter into the treated area; determining the position of the first radiopaque marker on the proximal part of the first catheter relative to the reference point and insertion of the second catheter until the second radiopaque marker on the second catheter matches the reference point, and the first and second markers contain dotted lines forming a ruler graduated with numbers. 8. The method of claim 8, further comprising the step of applying the treatment agent to the area to be treated via the second catheter. 9. The method according to any one of paragraphs. 7 or 8, in which the reference point is in the vascular bed. 10. The method according to any one of paragraphs. 7-9, in which the step of determining the position includes observing the first marker at a location in the body. 11. The method according to any one of paragraphs. 7-10, in which the step of determining the position includes observing the first and second markers under fluoroscopy. 12. The method according to any one of paragraphs. 7-11, in which the step of determining the position includes counting the first marker under fluoroscopy. 13. The method of influencing the treated area in the vascular bed, including: providing a first catheter having a first shaft containing a first distal part configured to be positioned in the treated area and a first proximal part containing a first radiopaque marker in the first location; And providing a second catheter having a second shaft containing a second distal part configured to be positioned at said first location and a second proximal part containing a second radiopaque marker at a second location substantially coinciding with the first location of the first radiopaque marker, where the first and second markers contain dotted lines forming a ruler graduated with numbers.

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