WO2009052818A1

WO2009052818A1 - Marking for surgical instruments and implants

Info

Publication number: WO2009052818A1
Application number: PCT/DE2008/001774
Authority: WO
Inventors: Franz Herbst
Original assignee: Franz Herbst
Priority date: 2007-10-25
Filing date: 2008-10-17
Publication date: 2009-04-30
Also published as: DE102007050969A1

Abstract

The present invention relates to a marking (1) for surgical instruments and implants - in particular for a dilation balloon (2) in PTCA catheters (3) for the dilation of strictures in the vascular system and furthermore for a stent, to achieve three-dimensional visualization of a two-dimensional recording of the marking (1), produced by computer tomography, fluoroscopy or in some other way, by means of an algorithm, which evaluates the space-specific data from a marking (1) present on the surgical instrument (3) or implant and the appearance thereof, characterized in that the marking (1) is arranged symmetrically around the surgical instrument (3) or the implant.

Description

DESCRIPTION

Marking for surgical instruments and implants

The present invention relates to a marker for surgical instruments and implants, in particular for a dilation balloon in PTCA catheters for dilatation of stenoses in the vascular system and also for a stent.

An insufficiently solved problem in minimally invasive surgery or surgery is the lack of visibility of an implant if it does not have sufficient X-ray contrast during or after implantation and it is not possible for the surgeon to observe the implant directly, but only with indirect methods such. As the computed tomography. Computed tomography allows X-rays to visualize the implant during and after implantation as long as the implant has sufficient X-ray contrast. If this contrast is minimal, e.g. in the case of very thin or small plastic implants or implants, the surgeon is dependent on radiopaque markers located on or in the implant, so that localization of the implant via these markers is possible. Typically, these markers are made from highly radiopaque metals, e.g. Platinum or gold.

For some implants, these radiopaque markers are sufficient, but for implants or procedures such as stents or dilatation catheters to open stenoses, these markers are completely inadequate or nonexistent. The cardiologist must rely on his many years of experience here and in the case of a stent implantation on the weak radiopaque contrast of the metallic implant. In the case of a pure balloon dilatation for the opening of a stenosis, only small radial or longitudinal movements are involved The catheter shaft or on the dilatation balloon attached radiopaque marker provided by the cardiologist can close the position of the balloon in the blood vessel indirectly. A direct visualization of the dilatation balloon is not possible because it is based on a polymer that does not have any radiopaque properties. For catheters that are not used for dilatation, these markers are applied to the shaft in radial or longitudinal form, which allow localization of the catheter but do not give any information as to which three-dimensional spatial arrangement the object to be observed has ,

The so-called balloon dilation describes a procedure in which vessels are widened. Specifically, a stenosis is usually diagnosed by the addition of contrast agents. By methods and methods known from PTCA (percutaneous transluminal coronary angioplasty) or PTA (percutaneous transluminal angioplasty), a dilatation catheter is guided to the stenotic areas via the lumen of the vessel. The dilatation catheter usually has an expandable balloon at the distal end, which is usually made of a high strength polymer such as nylon. The dilatation balloon can be expanded to a predetermined maximum dilation diameter. To do this, it is pressurized and inflated from the proximal end of the catheter via a lumen in the catheter shaft with a fluid. Radiopaque markers at each end of the balloon allow the cardiologist to determine where the balloon is at the moment. These radiopaque markers are usually not applied to the balloon, but on the catheter shaft, which leads pressure-tight through the balloon. Typically, the markers consist of two concentric strips of radiopaque material disposed about the catheter and attached to the distal and proximal ends of the balloon. They thus mark the balloon volume available for dilatation. A major disadvantage of this mark is that after inflation of the balloon, no statement can be made as to whether the balloon is actually inflated and, if so, how strong that inflation is. Likewise, no statement can be made as to whether the balloon is completely concentrically inflated or whether there are areas in the open stenosis that could not be fully opened. The attending physician is blind at this moment and can not tell if the dilatation was successful. Even after the treatment and application of a contrast medium into the vessel, it can not be said with certainty whether the vessel is completely open or whether there are areas that have not been opened. The reason for the failure of this method is that an X-ray computer tomograph provides a two-dimensional image and there is not enough data to convert it to a three-dimensional image of the stenosis. It is possible that the stenosis appears open in the X-ray, but in reality it still has spots that have not been opened.

EP0244818B1 also proposes a radiopaque means having a radiopaque ring member peripherally formed on the catheter to intersect an axial or axial direction of the catheter, the ring member being provided with a portion having no or less radiopacity extends in the axial direction of the catheter. It describes a marker on catheters that do not have a balloon portion that is dilatable. The disadvantage of this embodiment described in EP0244818B1 is that it is not possible to detect even small distortions, since only a discontinuous correlation of the analytical elements is described here. An exact statement about Distorsionen with recordings (pictures), which were generated directly perpendicularly to the radiation source, is not possible. The ring elements appear only as rectangles. The present invention has for its object to provide an optimal arrangement of a computer tomography, fluoroscopy or otherwise two-dimensional mapable marking on medical instruments and implants, in particular dilatation onskathetern, catheters and stents.

The arrangement and geometry of this marking on dilatation catheters or other medical instruments or implants should fulfill the following tasks:

First, the mark must not alter the mechanical behavior of the medical instrument or implant. Second, it must be two-dimensionally imageable by computed tomography, fluoroscopy, or otherwise, and third, they must be arranged so that one can deduce from the two-dimensional image of the mark the three-dimensional arrangement of the medical instrument or implant. Here, the evaluation of the individual marking positions with the aid of an algorithm should make it possible to calculate an exact three-dimensional image of the medical instrument or implant, insofar as a clear statement can be made as to whether the marking or a part thereof is located on the Observer facing side or opposite side is located.

To achieve this object, it is proposed according to the present claim 1 that the marking for surgical instruments and implants for realizing a three-dimensional visualization from a computer tomographic, fluoroscopic or otherwise created two-dimensional image on the surgical instrument or implant circumferentially symmetrical. Using an algorithm that evaluates the space-specific data from the mark and appearance present on the surgical instrument or implant can provide an accurate and accurate result Three-dimensional representation can be calculated from a two-dimensional computer tomographic or other kind of mapping.

In terms of method, it is proposed in this regard that the evaluation of the two-dimensional image of the marking according to the invention for surgical instruments and implants takes place with the inclusion of the following parameters:

Angle and Angle Distortions of Mark Lines - Optical Angle and Angle Distortions of Mark Lines optical truncations or extensions of marking lines

Distortion Distortion Lines Optical Distortion Between Mark Lines - Optical Off Gain Magnification or Reduction of Mark Lines

Foreshortenings or extensions of spiral helices Distortions in the diameter of a spiral helix Distortions in the diameter of a spiral

in the two-dimensional image formed over the symmetrically arranged mark. In addition, the use of other parameters is quite conceivable. All analytical elements of the label are linked in continuous correlation to one another and over the entire range.

The advantages of the present marker are versatile: For example, the invention makes it possible to observe a direct observation of the inflation process during the treatment by means of a special arrangement of the marker, for example on a balloon membrane, and to make a statement as to how far the balloon was able to open the stenosis and possibly where Still stenotic areas are present, which were not open. A simple view of positioning The marking on the balloon allows the cardiologist to make a statement about the extent to which the stenosis could be opened or not.

A dilatation balloon coated in the form of the proposed marker is also suitable as a carrier for a stent. As a rule, stents are poorly radiopaque and their structure is difficult to detect after dilatation in the vessel. However, if a stent is dilated with the help of a radiopaque balloon, the same effects as in the case of the mere dilatation of a balloon come into play. Thus one can carry out a precise analysis of the stent opening and recognize in which areas there is only partial opening of the stent. It is also possible to integrate the radiopaque marker directly on the stent surface or into the stent. This makes it possible to accurately locate the stent during its implantation. Furthermore, the stent can be observed at any time throughout its lifetime and it can be determined whether structural problems of the stent occur and where these areas are located in the stent.

In addition, the proposed mark can be applied to all medical instruments, which are constructed of tubular structures, and determine the exact positioning of these devices in the body by computer tomographic evaluations. It is e.g. possible to track the exact course of a catheter shaft from the proximal to the distal end. Each type of catheter can be marked in this way radiopaque and is therefore easy to track visually.

The symmetrically arranged marking is applicable to medical instruments or implants of any shape and size. Here, the object can also be labeled with a grid of radiopaque markers such as spirals, polygons, marker lines, points or combinations are symmetrically coated. The medical instrument or implant becomes directly visible by analysis of these markers in the manner described above. By analyzing the angles and the structure of the polygons or marking lines, a three-dimensional image can be generated.

In the case of punctual symmetrical marking, a three-dimensional image of the stenosis can be generated by analyzing the point distances to one another.

There are a number of other geometrical arrangements of the mark, all based on the same principle: analysis of the angles and distances of given points from each other and incorporation of these data in a given geometry.

The marking in a radiopaque embodiment can be made of a wide variety of materials. Here are mainly the following elements or their chemical derivatives are used: barium, hafnium, tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, lead, and bismuth. In addition, the use of other materials is not excluded.

However, the marking is not limited to being radiopaque, it can also be made of any other material that allows to create a contrast image or the like, which is subsequently represented in an image. Applications of fluorescence and luminescence labeling are conceivable, but by no means limited to these.

For the attachment of the marking on surgical instruments and implants, reference may be made to the well-proven in the prior art method. However, it must be ensured that the method of attachment of the marker does not provide the resistance of the instrument or implant significantly or preferably not affected at all.

Other objects, features, advantages and applications of the invention mark will become apparent from the following description of several embodiments with reference to the drawings. All described and / or illustrated features, alone or in any combination form the subject matter of the invention, regardless of the summary in individual An-claims or their relationship.

Show it:

1 shows a PTCA dilatation catheter 3 with dilatation balloon 2 and a circumferential symmetrical marking 1 in the form of a clockwise helical helix (also referred to below as spiral), FIG.

2 shows a PTCA dilatation catheter 3 with a circumferential symmetrical marker 1 in the form of a double helix,

2a is an enlarged view of the double helix,

3 shows an image of an encircling symmetrical marking 1 in the form of a clockwise helix without distortions 8. The left end 7 of the clockwise spiral spiral 1 with the spiral spiral segment 13 faces the observer and lies above the spiral axis 6. The spiral spiral segment 14 is the observer turned away and lies below the spiral axis 6,

4 as in FIG. 3, edge vectorized as a raster graphic,

5 as in FIG. 3, with distortions 13, 6 as in FIG. 5, edge vectorized as a raster graphic,

7 shows an image of an encircling symmetrical marking 1, wherein the object is coated with a marking network of polygons 15 (here: triangles) 15,

8 shows a PTCA dilatation catheter 3 with dilatation balloon 2 and symmetrically arranged, longitudinal linear markings 1,

9 shows a PTCA dilatation catheter 3 with dilatation balloon 2 and markings 1 running parallel to it, each having bulges 16 arranged on the inside,

10 shows a further embodiment and arrangement of the protrusions 16 on the markings 1 of the PTCA dilatation catheter 3,

Fign.lla-d Images of a dilatation balloon 2 with circumferentially symmetrically arranged markings 1 as in FIG. 8 with different forms,

12 shows an image of a dilatation balloon 2 with markings I as in FIGS. 11a-d, with respectively front and back side stenosis 8.

As shown in Fig.l, the symmetrically arranged marker 1 in a preferred embodiment in the form of a spiral, which is here applied to the expanded balloon surface of a dilatation balloon 2 of radiopaque material and winds from the distal to the proximal end of the balloon 2.

2 and 2a show a symmetrically arranged marking 1, which has the shape of a double helix. As can be seen in FIG. 2a, further optical intersections 4 of the double helix are visible meet at a certain angle 5. These angles 5 will change if there is a distortion 8 of the double helix. The analysis accuracy of the overall picture is thereby increased. Introducing a triple helix results in further optical intersections 4 and angles 5. The more angles 5 of an evaluation are available, the more accurate is the three-dimensional reconstruction.

As can be seen from FIG. 3 and FIG. 4, the spiral appears in a two-dimensional image, in the case of a completely symmetrical opening of the dilatation balloon 2, as a symmetrical zigzag line with alternating angles which are completely identical. Angle 5 depends on the slope of Spiral and the diameter of the balloon 2 open and precisely set by this geometry in advance. From the data of the resulting angles 5, as well as from the data of the balloon diameter and a possible distortion of the zigzag line, it can be seen exactly whether the balloon 2 is symmetrically opened or there are areas which have not been opened and what these areas look like. Using an algorithm, an accurate three-dimensional image of the opened balloon 2 can be calculated by correlating this data. In addition, it is possible to determine the stenotic condition of the lesion as well as the exact spatial locations at which the stenosis was not properly opened. The strength of the openings is determinable. Furthermore, a clear statement about it is possible that in a clockwise spiral all spiral spiral segments 13, which extend from left to right, facing the viewer, ie above the spiral axis 6 and all spiral spiral segments 14 which extend from right to left, below the spiral axis 6 and are facing away from the viewer. All occurring spiral angle 5 are not bent in the figure in Figure 3 and the same. Both the Spiralhalbstrecken 9, the distances between the spiral tips 10, the diameter of the spiral 11 and the diameter of the spiral coil 12 are the same everywhere. If it is a clockwise radiopaque spiral that winds around the balloon 2 from the distal end of the balloon 2 and the start of the zigzag line to be observed in the computed tomography image is from left to right, the distal end of the spiral is located on the to the viewer facing side on the balloon surface. However, if the observer recognizes a zigzag line that runs from right to left, the distal start of the spiral is located on the side of the balloon 2 facing away from the observer. Exact analysis of the start of the zigzag line reveals how the dilatation balloon 2 spatially is placed.

During the inflation of the balloon 2 in the stenotic vessel, one can create an exact three-dimensional image by the data described above. It is thus possible to immediately recognize where there are potential problems during dilatation and to act accordingly. By means of a computer program preferably switched online, a three-dimensional image of the stenotic vessel can be calculated, which consists solely of the analysis of the data such as balloon diameter, zigzag twist, torsion of the zigzag angle, length of a half zigzag line and analysis of the start of the zigzag line of links or Right beginning, based.

If it comes to the distortion of the spiral by occurring stenoses, as shown in Figure 5 and Figure 6 results in the case of three stenoses 8. The left end 7 of the spiral spiral with the spiral spiral segment 13 faces the viewer and is above the spiral axis. The spiral spiral segment 14 faces away from the observer and lies below the spiral axis 6. Not all spiral angles 5 are the same. Distortion of angles 5 occurs. Not all spiral half-lines 9 are the same. It comes to optical shortening or extension of the half-tracks 9. Neither the distances between the spiral tips 10, the diameter 11 of the spiral, nor the Durchstr. The diameter of spiral spiral 12 are the same everywhere, but sometimes extremely distorted.

FIGS. 8-10 show further preferred exemplary embodiments of symmetrically arranged markings 1 on a PTCA dilatation catheter 3 with dilatation balloon 2, which reveal a clear placement of the surgical instrument and implant.

8 shows an embodiment obliquely and at an angle arbitrary degrees parallel linear markings 1. In this embodiment, the markers 1, the catheter 3 and the balloon 2 from bottom left to top right are on the one, whereas the bottom left to right above the viewer facing side, whereas the left from top to bottom right markings are arranged on the side facing away from the viewer of the catheter 3. As a result of this structural arrangement of the markings 1, a clear assignment of the front and rear sides of the dilatation catheter 3 can be made and the degree of distortion (distortion) calculated and evaluated on evaluation of the occurring real and visual distortions of the marking lines and their geometrical position 3 dimensional image are built.

A further advantageous embodiment of the dilatation catheter 3 shown in FIGS. 9-10 provides for arranging longitudinally and parallelly extending markings 1, each of which has recesses 16 on the inside. As shown in Figs. 9 and 10, these lobes 16 may have a variety of shapes and orientations that enable one to make a directional statement as to the inserted catheter or other surgical instruments and implants. Finally, FIGS. 11a-12d and 12 show images of a dilatation balloon 2 with circumferentially symmetrically arranged markings 1 with different characteristics, as has already been shown in FIG. 8, the markings 1 arranged at the rear being punctiform.

Marking 1, as shown in FIGS. 11a-d and 12, whose marking lines 1 point longitudinally to the axis of the dilatation balloon 2 and which are each offset by the value x on the left and right sides, have the advantage that a continuous negative of FIG Stenosis 8 images on the marking lines. In a spiral, there is a discontinuous mapping, since only certain spiral segments, which are indeed in interaction with each other, but spatially separated from each other, allow a negative imaging of the stenosis 8. In a marker line 1 as in the latter case, there is no spatial separation within the affected by the stenosis 8 points. This results in a finer resolution and a better negative impression of the stenosis 8. In FIG. 12, a dilatation balloon 2 with respectively front and back side 8 is illustrated for clarification. Recognizable in FIGS. 11a-d and 12 are the optical angles 17 at the visual intersections of the front and rear markings 1, and also the optical changes of the marking distances / distortions 18.

The marking 1 according to the invention is not limited in its execution to the above-mentioned preferred embodiments. Rather, a variety of design variations are possible, which make use of the solution shown even with fundamentally different type of execution. List of reference numbers:

1 circumferentially symmetrically arranged marking; spiral coil

2 dilatation balloon; Balloon 3 PTCA dilatation catheter

4 intersection of the (double) helix

5 angles

6 spiral axis

7 left end of the clockwise spiral 8 Stenosis; distortion

9 spiral necklaces

10 Distance between the spiral tips

11 diameter of the spiral

12 diameter of the spiral spiral 13 facing the viewer spiral spiral segment

14 facing away from the viewer spiral spiral segment

15 polygons in the form of triangles

16 bulges

17 optical angles 18 distortions / marking distances

Claims

CLAIM mark for surgical instruments and implants

A marking (1) for surgical instruments and implants for the realization of a three-dimensional visualization from a computer tomographic, fluoroscopic or otherwise created two-dimensional recording of the marker (1) by means of an algorithm, the space-specific data from an existing on the surgical instrument or implant Marker (1) and their appearance evaluates, characterized in that the marking (1) on the surgical instrument (3) or implant circumferentially symmetrically arranged and configured such that it allows a clear assignment of the geometric position of the marker (1).

2. marking (1) for surgical instruments and implants according to claim 1, characterized in that they point longitudinally to the axis of the surgical instrument or implant and the left and right sides are offset by the value x.

3. marking (1) for surgical instruments and implants according to claim 1, characterized in that it preferably has the shape of a helix on the surgical instrument or implant.

4. marking (1) for surgical instruments and implants according to claim 1, characterized in that it preferably on the surgical instrument or implant in the form of a double or multiple helix.

5. marking (1) for surgical instruments and implants according to claim 1, characterized in that medical instruments or implants are coated symmetrically with a marking network of markers such as spirals, polygons (15), marking lines, points or combinations thereof.

6. marking (1) for surgical instruments and implants according to claim 1, characterized in that they extend at an angle of any degree parallel to each other, such that the markings (1) on the catheter (3) or the balloon (2 ) from bottom left to top right on the side facing the observer, whereas markings extending from top left to bottom right are arranged on the side of the catheter (3) facing away from the observer.

7. marking for surgical instruments and implants according to claim 1, characterized in that it each on the instrument or implant front and rear lower and upper side bulges (16).

8. marking (1) for surgical instruments and implants according to one or more of the preceding claims, characterized in that it takes place selectively.

9. marking for surgical instruments and implants according to one or more of the preceding claims, characterized in that the marking (1) on a dilatation catheter (2) with dilatation balloon (2) is arranged and extending from the distal to the proximal end of the balloon (2 ) winds.

10. A method for evaluating the two-dimensional image of the marking for surgical instruments and implants according to one or more of the preceding claims, characterized in that the evaluation is based on the following parameters: a) angle and angular distorsions (5) of marking lines

(D, b) optical angles (17) and angular distortions of

C) optical shortening or extensions of marking lines (1), d) distortions of distances between marking lines (1), e) optical distortions (18) between marking lines (1), f) optical distance increase or reduction of marking lines 1), g) shortening or lengthening spiral hairlines (9), h) distortions in the diameter of the spiral spiral (12), i) distortions in the diameter of the spiral (11).