WO2019011801A1 - MEDICAL, IMPLANTABLE MARKER AND DEVICE FOR IMPLANTING THE MARKER - Google Patents

Abstract

Described is a medical, implantable marker for temporary or permanent positioning within an intracorporeal tissue region, consisting of a biocompatible and sonographically different from the rest tissue region material. Furthermore, an apparatus for implanting the marker in an animal or human tissue region is explained, comprising a hollow cannula with a slanted obliquely to the hollow needle longitudinal axis and at a distal cutting edge, preferably in the form of a cutting tip cutting surface, and a longitudinally movably mounted inside the hollow cannula Mandrin. The marker according to the invention is characterized in that the marker is a body with a matrix consisting of an elastic material which at least partially encloses a large number of pore-like volumes. For implanting the marker, the body is arranged in a compressed state within the hollow cannula of the device so that the body terminates the hollow cannula in a fluid-tight manner on the distal side. The stylet is mounted centrally or directly proximal side to the body for conditioning brought to separate the body by relative movement between the hollow cannula and stylet from the hollow cannula.

Description

 Medical, implantable marker and device for implanting the

 Markers

Technical area

The invention relates to a medical, implantable marker for temporary or permanent positioning within an intracorporeal

Tissue area consisting of a biocompatible and by means of

Sonographic diagnosis of the remaining tissue area distinguishable material. Furthermore, an apparatus for implanting the marker in an animal or human tissue region is explained, comprising a hollow cannula with an obliquely inclined to the hollow cannula longitudinal axis and at a distal cutting edge,

preferably in the form of a cutting tip opening cutting surface, and a longitudinally movably mounted within the hollow cannula mandrin.

State of the art

 Make medically implantable markers in the generic sense

A three-dimensional objects or body that a doctor for the purpose of localization of intracorporeal tissue sites or areas by means of a minimally invasive procedure, usually using a puncture or parts of a

Biopsy needle arrangement located intracorporeally. The marking of tissue areas, for example, in the context of a drug therapy of

Tumors that are no longer visible on successful treatment using conventional diagnostic imaging techniques, such as X-ray, computed tomography, sonographic or magnetic resonance methods. To observe the success of the treatment, the markers implanted on the treated tissue area serve. The document DE 44 24 394 B4 discloses a wire-like marking unit which has at least two wire strands twisted together whose distal end sections are not twisted together and have arcuate barb elements projecting from the common twisting axis. For introducing the wire-like marking unit serves a

Hollow needle. The twisted wire strands are made of a shape memory metal alloy, so that the distal end portions form the arcuate barb elements after leaving the hollow needle tip independently.

The document DE 10 2010 048 736 A1 also discloses a wire-like

Marking unit, which is intracorporeal placeable by means of a hollow needle and consists of at least two wires twisted together, with a distal

Wire end portion, which forms a closed ring due to a material-inherent shape impression after the distal ejection through the hollow needle, which encloses at least an angle of 360 °. The annularly forming distal wire form within a tissue region to be marked is advantageously characterized by negligible intracorporeal migration and improved visibility by means of conventional imaging diagnostic methods and good localization associated therewith.

In contrast to the above wire-shaped marking units, whose proximal ends percutaneously protrude outward after intracorporeal positioning of their marking ring and thus represent a minimum impairment at least for the person in question, the document DE 10 2004 055 583 A1 discloses a completely intracorporeal placeable marker in the form of a Closed ring, which can be minimally invasively placed using a delivery device consisting of a hollow needle and a longitudinally movably mounted within the hollow needle stylet. The circular marker consists of

at least two thin, mutually twisted, consisting of shape memory material strands, preferably nickel-titanium, which are pushed in a straight twisted extension with the help of the stylet through the intracorporeally placed hollow needle and after distal exit through the hollow needle automatically deform into a closed ring marking the relevant tissue site. The hollow needle and stylet are removed extracorporeally, so that the intracorporeal markers for the person concerned does not cause any impairment.

Document US 2009/0131734 A1 discloses an implantable medical marker and a method for producing the same. The marker has a medical grade for better visibility

Gamma ray emitting material imaging method

preferably in the form of so-called "micro-spheres", that is to say the "microspheres" consist entirely of gamma-emitting material. The capsular or spherical gamma-emitting material is embedded in a so-called "soft matrix." The soft matrix is made of a non-hardenable material that remains in an amorphous state.

The publication US 2015/0010470 A1 describes radioactive radiation sources, so-called "strands", for performing a brachytherapy.

Presentation of the invention

 The invention is based on the object of a medical, implantable marker for temporary or permanent location within an intracorporeal tissue area, consisting of a biocompatible and means

sonographic imaging diagnostics of the remaining tissue area

distinguishable material, so that in particular the important for a doctor visual detectability using sonographic, imaging examination methods to be improved over known markers. It is also necessary to train the marker in such a way that the

Acceptance by a patient, who must ultimately agree to the surgical procedure for placing the marker, should be substantially improved. Furthermore, it is a To provide a device for implanting the novel marker, by which the patient burden is to be reduced by the minimally invasive procedure.

The solution of the problem underlying the invention is specified in claim 1. A device according to the invention for implanting the

according to the invention marker is specified in claim 9. The solution ideas in an advantageous manner further developing features are the subject of the dependent claims and the further description, in particular with reference to the

Refer to exemplary embodiments.

According to the solution, a medical, implantable marker for temporary or permanent localization within an intracorporeal is characterized

Tissue region consisting of a biocompatible, distinguishable by sonographic diagnostics from the rest of the tissue range material characterized in that the marker is a body with a matrix consisting of an elastic material, which at least partially encloses a plurality of pore-like volumes.

The idea according to the invention was preceded by a large number of sonographic examinations of tissue materials into which markers made of different materials, with different shapes and sizes and different material consistencies, i. Density, material homogeneity or heterogeneity etc. have been placed. It has often been found, especially in annular markers, which are made of at least two wires twisted together, that of the rest

Tissue region contrasting significant sound echo image of the ring marker crucial of the sound direction under which the ring marker is hit by the ultrasonic waves, depends. Despite a winding structure impressed on the ring form, it is necessary for a trained and experienced eye to detect the marker in the event of sonication in the ring plane in relation to the surrounding tissue area.

In contrast, it was found that when using a marker whose consistency is formed in the manner of a foam, which is characterized by reflection of Ultrasonic waves at the marker in the ultrasound image visually looming reflection image characteristic and high contrast of the surrounding

Tissue area lifts off. Such a marker has a matrix consisting of an elastic material, which includes closed-pore volumes, in each of which a gas, preferably air, is contained.

Due to the internal, heterogeneous structure or consistency of the marker and the resulting multiple reflections of the ultrasound waves interacting with the body, the cross-sectional shape of the marker in the direction of transmission on a sonogram or ultrasound image is distinguished in high contrast. With a preferably spherical shape of the

Marker body or in the form of an ellipsoid, the marker emerges from all

Durchschallungsrichtungen equally strong contrast rich in appearance.

In addition, as a further unique identification characteristic of the marker on a sonogram, a type of ultrasound wave reflection tail is formed, which directly adjoins the marker in the direction of sound transmission and appears in high contrast. These ultrasonic wave reflection signals are due to those occurring within the heterogeneous foam structure of the marker body

Multiple reflections, which are due to the large number of closed-pore volumes within the matrix.

In addition to the high-contrast ultrasound image of the marker, which is already showing a high contrast, the visual conspicuity of the marker on the sonogram is significantly improved by the reflection tail described above.

It is also possible to form a marker whose matrix consisting of elastic material is formed in regions in the manner of a foam structure as well as in regions in the manner of a sponge structure.

In all cases, it is the matrix of a biocompatible elastic material, preferably a biocompatible plastic, in particular one To manufacture silicone material with appropriate implant-approved certification. A suitable material is, for example, under the

Designation "MED-2310" of the company Nusil Technology LLC

Silicone-based plastic is obtained by mixing two components and, depending on the processing, forms a foam and / or sponge structure, which in both cases has a silicone-based elastic matrix.

The marker according to the invention, which is characterized by a heterogeneous material structure and whose consistency is characterized by the elastic matrix, has a specific weight which is roughly comparable to the specific weight of an intracorporeal tissue to be marked, whereby a marker introduced within a tissue area is permanent and remains stable at the originally placed tissue area. Migration-related changes in location, which can be permanently adjusted by specific weight differences between marker and tissue, as may be the case with markers made of metal, do not occur with the marker according to the invention.

In a preferred embodiment, the marker has an open-pored surface through which an anchoring process is conditioned by local ingrowth of the surrounding tissue into the structured or open-pore

Marker surface is supported or improved.

Depending on an imaging method used in each case for the visual localization of the marker designed in accordance with the invention, it is used primarily for the use of sonographic examination methods which are particularly useful

patient-friendly, is designed, the elastic material of which the matrix consists, additionally at least one substance admixed or be applied to the matrix surface, which has interaction properties by which the substance and thus the marker also in imaging X-ray, computed tomography or magnetic resonance method becomes visible. Such a substance is for example an X-ray contrast agent, preferably in the form of Barium sulfate, or may have magnetic or magnetizable particles or metallic powder.

Similarly, it is advisable in a further embodiment to combine the marker with a medicinal agent, so that the marker next to his

Marker function also serves as a carrier for a medical drug, by which within the tissue area in which the marker is implanted, a certain medical drug delivery is feasible, with respect to their

Concentration and time of delivery can be selected appropriately.

Basically, the size and shape of the marker is freely selectable and adaptable to the respective application requirements. It has proved to be particularly advantageous to form the marker spherical or in the form of an ellipsoid, especially in such body shapes in the direction of the sound behind the respective

Marker body form characteristic ultrasound echo signals, which represent on the sonogram, as it were a body shadow through which the

Detection security of the marker is increased on the diagram.

In order to minimize the patient-side burden of the minimally invasive procedure for the purpose of implanting the marker in a tissue area of medical interest, a hollow needle as thin as possible, preferably hollow needles with diameters typically from 14 ga to 18 ga, i. 1, 6 mm to 1, 02 mm. This diameter dimension limits a maximum possible marker diameter, especially since the marker is to be placed in a compressed state within the hollow cannula for the purpose of implantation.

For implanting the marker is preferably a hollow cannula with an obliquely inclined to the hollow needle longitudinal axis and at a distal cutting edge, preferably in the form of cutting tips opening cutting surface, and a longitudinally movably mounted within the hollow cannula Mandrin, wherein the marker in a compressed state so within the Hollow cannula is arranged so that the marker, the hollow cannula on the distal side fluid-tight and the stylet middle or directly proximal side is brought to the compressed marker to the plant to ultimately distally move the marker by relative movement between the hollow cannula and stylet from the hollow cannula and to separate from the hollow cannula. As soon as the marker exits the hollow cannula on the distal side via the stylet, the marker assumes its original, relaxed spatial form and is completely surrounded by the surrounding tissue.

For handling and controlled placement of the marker within the

Tissue region provides the hollow cannula as well as the stylet ever a proximal-side attached handling agent, which is a separate or combined

bidirectional movement of the hollow cannula and / or the mandrin allows

Preferably, they are attached to the stylet and to the hollow cannula

Handling means coupled via a gear, through which the relative movement between stylet and hollow cannula is defined. Preferably, the transmission is designed such that an inverse movement conversion between stylet and hollow cannula is realized, i. E. in the case of a distally oriented movement of the mandrin, the hollow cannula is withdrawn proximally. The transmission in this case preferably has an inverse ratio of 1: 1, i. a distal movement of the mandrin leads to a proximal movement of the hollow cannula to the same extent and vice versa. In this way, it is possible to place the hollow cannula equipped with the marker intracorporally exactly, so that the marker is located in the tissue at the location of the intracorporally placed cutting surface, i. the cutting tip of the hollow cannula moves proximally during the dispensing process, so that no further tissue lesions during the dispensing process

Ausbringvorganges be caused.

Brief description of the invention

 The invention will hereinafter be understood without limitation of the general

Inventive idea using exemplary embodiments with reference to the drawings described by way of example. Show it: 1a, b different embodiments of a marker,

2 sonogram with marker,

Fig. 3 illustration of the Ausbringvorganges a marker with a

 Hollow cannula mandrin arrangement as well

Fig. 4a, b apparatus for implanting a solution according to

 trained marker

Ways to carry out the invention, industrial usability

 FIG. 1a shows a marker 1 in the form of a sphere, which has a large number of pore-like volumes 2, which is surrounded by a matrix 3 of elastic material, preferably of medically approved silicone material.

The gas-filled, preferably with air, filled pore-like volumes 2 are not necessarily the same size, but are subject to a statistical

Size distribution. The illustrated in Figure 1a embodiment has a substantially smooth spherical surface.

FIG. 1b shows an alternative form of the marker 1 in the form of an ellipsoid, which as it were has a foam-structure-like matrix 3, but which has regions 2 'open to the outside in some regions. To the open-pore volumes 2 ', open-pore partial volumes 2', in the manner of a sponge structure, can join, as it were, into the depth of the matrix. Thus, the illustrated in Figure 1b

Embodiment over both sponge structure areas in which the individual sub-volumes 2 'are connected open-pore, as well as over

Foam structure areas with self-contained pore-like volumes 2. In principle, there are no limits to the shaping as well as the design of the matrix in the form of a sponge structure. The markers of the invention are compressible due to the elastic matrix material 3 and have a

specific gravity comparable to the specific gravity of biological, human or animal tissue. The specific gravity of the marker 1 may depend on the specific gravity of the biological

Fabric material with a tolerance of +/- 30%.

The marker according to the invention is distinguished by excellent

Ultrasound reflection properties, so that the marker visually stands out against the biological tissue 4 in the context of an ultrasound examination on the ultrasound image or sonogram.

FIG. 2 shows a sonogram of a tissue region 4 in which the marker 1 according to the invention is implanted. It is assumed that the tissue region 4 is sonicated with an ultrasonic field propagating along the plane of the drawing from right to left. Due to the internal heterogeneous structure of the marker 1, caused for example by the internal sponge structure, a large number of ultrasonic wave reflections occurring within the marker occur

Sonogram as a characteristic in the propagation direction behind the marker 1 arranged ultrasonic reflections, comparable to a

 Ultrasonic reflection shadow 1 '. In addition to the over the surrounding tissue 4 high-contrast representing marker image 1, which is clearly recognizable to a physician, the ultrasonic wave shadow V forms another for the marker

Characteristic identifier, so that the localization security is significantly increased.

The marker according to the invention causes the patient due to the intrinsic material elastic properties of the marker as a pleasant

perceptible haptic impression that the patient undergoes when the marker is inspected, so that the patient-side acceptance is decisively improved with regard to a purchase of a minimally invasive procedure, in comparison For example, to previously known markers made of a metallic material through which a tissue area to be marked is subject to a greater risk of lesion.

FIG. 3 shows a device for implanting the marker 1, which has a hollow cannula 5 with a distal cutting edge with a cutting tip 6 and one

Cutting surface 7. The cutting surface 7 is inclined relative to the hollow needle longitudinal axis 8. Inside the hollow cannula 5, a stylet 9 is longitudinally movably arranged, at the proximal end of a handling means 10 is attached. In the same way, the proximal end of the hollow cannula 5 has a corresponding one

Handling means 1 1 on. Both handling means 10, 1 1 are coupled via a transmission 12, which by correspondingly manual operation of both

Handling means 10, 1 1 for a separate or combined bidirectional

Movement of hollow cannula 5 and / or stylet 9 provides.

For introducing a marker 1 into a tissue region to be marked, the marker 1 is inserted into the hollow cannula 5 distally in a compressed state such that the marker 1 terminates the hollow cannula 5 at the distal end in a fluid-tight manner. In the exemplary embodiment illustrated in FIG. 3, the stylet 9 is brought into contact with the marker 1 directly on the proximal side in order to separate the marker 1 from the hollow cannula 5 by advancing the stylet 9 distally.

Also conceivable is fitting the hollow cannula 5 with a plurality of markers 1, which are arranged serially one behind the other along the hollow cannula 5. In this case, the stylet 9 would exert an axially directed delivery pressure over all the markers 1 mounted within the hollow cannula 5, in order to push the marker located at the distal end out of the hollow cannula 5.

FIG. 4a shows the distal region of a hollow cannula 5 equipped with a marker 1 and a mandrin 9 mounted proximally to the marker. It is assumed that the hollow cannula 5 is placed intracorporally up to a defined position x in a surrounding tissue region 4. For the purpose of spreading of the marker 1 from the hollow cannula 5, the stylet 9 moves distally forward and pushes in this way the marker 1 through the opening of the hollow cannula 5 therethrough. At the same time, the hollow cannula 5 is withdrawn proximally. In this way, the marker 1 is placed exactly at the point at which the opening of the hollow channel 5 has been placed in the image representation according to FIG. 4a.

This is on the one hand for the doctor very beneficial, especially since the doctor can accurately specify the exact location of the marker placement by the positioning of the hollow cannula 5. In addition, the tissue area 4 is not further damaged during the marker placement. FIG. 4b illustrates a situation in which the marker 1 assumes its original spherical shape, which typically has a diameter between 2 and 4 mm.

The above-explained controlled spreading of the inside of the hollow cannula 5 stored stored marker 1 sets a coordinated

Movement dynamics between hollow cannula 5 and stylet 9 ahead. The illustrated in Figure 3 transmission 12 provides for manual actuation of the handling means 10 and 1 1 for an inverse motion implementation, preferably with an inverse ratio of 1: 1, ie a distal movement of the stylet 9 leads to an equal proximal movement of the hollow cannula. 5

List of Reference Markers

'Ultrasonic wave tail

 Pore-like volumes

'Open-pore volumes

 matrix

 tissue area

'Ultrasonic Shadow Reflexes

 hollow cannula

 cutting tip

 cutting surface

 Hollow cannula longitudinal axis

 mandrin

0, 1 1 handling agent

2 gears

Claims

claims 1 . Medical, implantable marker for temporary or permanent localization within an intracorporeal tissue region, consisting of a biocompatible and by sonographic diagnosis of the other tissue area distinguishable material, characterized in that the marker is a body with one of a elastic matrix material which at least partially encloses a multiplicity of pore-like volumes, and in that the matrix has at least regions in which the volumes in the form of a foam structure are closed-pored and respectively include gas or air. 2. Marker according to claim 1, characterized in that the matrix consists of a biocompatible plastic. 3 markers according to claim 2, characterized in that the biocompatible plastic from a Silicone material exists. 4. Marker according to one of claims 1 to 3, characterized in that the body is in the form of a sphere or ellipsoid free of external forces, having a body diameter between 1.5 mm and a maximum body diameter, limited by the body in a compressed state by an 18G / 1, 25mm hollow needle is eligible. 5. Marker according to one of claims 1 to 4, characterized in that the body has an open-pored surface. 6. Marker according to one of claims 1 to 4, characterized in that the body has a closed surface. 7. Marker according to one of claims 1 to 6, characterized in that the body has a specific weight corresponding to the specific gravity of the tissue area with a tolerance of deviation of ± 30%. 8. Marker according to one of claims 1 to 7, characterized in that at least one second substance is contained in the matrix or is applied to the matrix, and the second substance is at least one of the following: an X-ray contrast agent, preferably in the form of barium sulfate, a medicinal agent, magnetic or magnetizable particles, metallic powder. 9. Device for implanting the marker according to one of claims 1 to 8 in an animal or human tissue region, comprising a hollow cannula with an obliquely inclined to the hollow needle longitudinal axis and at a distal cutting edge, preferably in the form of a cutting tip opening cutting surface, and within the Hollow cannula longitudinally movably mounted stylet, characterized in that the body is arranged in a compressed state in such a manner within the hollow cannula, so that the body, the hollow needle distal ends fluid-tight, and in that the stylet is mounted on the body for placement directly or indirectly on the proximal side in order to separate the body from the hollow cannula by relative movement between the hollow cannula and the stylet. 10. Apparatus according to claim 9, characterized in that on the proximal side both on the hollow cannula and on the stylet ever a handling means is attached to the separate or Combined bidirectional movement of hollow cannula and / or stylet. 1 1. Device according to claim 10, characterized in that the mandrin and on the hollow cannula attached handling means are coupled together via a gear, and that the transmission realizes an inverse movement implementation between stylet and hollow cannula. 12. Device according to claim 1 1, characterized in that the transmission has an inverse ratio of 1: 1, i. a distal movement of the mandrin leads to a Proximal movement of the hollow cannula to the same extent and vice versa.